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Stock Code : 2595
(A joint stock company incorporated in the People’s Republic of China with limited liability)
GLOBAL OFFERING
勁方醫藥科技 ( 上海 ) 股份有限公司
GenFleet Therapeutics (Shanghai) Inc.
Sole Sponsor, Sole Sponsor-Overall Coordinator,
Joint Global Coordinator, Joint Bookrunner and Joint Lead Manager


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IMPORTANT: If you are in any doubt about any of the contents of this Prospectus, you should seek independent professional advice.
GenFleet Therapeutics (Shanghai) Inc.
ʮ̡
(A joint stock company incorporated in the People’ s Republic of China with limited liability)
GLOBAL OFFERING
Number of Offer Shares under the
Global Offering
: 77,600,000 H Shares (subject to the
Offer Size Adjustment Option and the
Over-allotment Option)
Number of Hong Kong Offer Shares : 7,760,000 H Shares (subject to
reallocation)
Number of International Offer Shares : 69,840,000 H Shares (subject to
reallocation, the Offer Size Adjustment
Option and the Over-allotment
Option)
Offer Price : HK$20.39 per Offer Share, plus
brokerage of 1.0%, SFC transaction
levy of 0.0027%, AFRC transaction
levy of 0.00015% and Hong Kong
Stock Exchange trading fee of
0.00565% (payable in full on
application in Hong Kong dollars and
subject to refund)
Nominal value : RMB0.1 per H Share
Stock code : 2595
Sole Sponsor, Sole Sponsor-Overall Coordinator, Joint Global Coordinator,
Joint Bookrunner and Joint Lead Manager
Overall Coordinators, Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers
Joint Bookrunners, Joint Lead Managers and/or Joint Global Coordinator
Hong Kong Exchanges and Clearing Limited, The Stock Exchange of Hong Kong Limited and Hong Kong Securities Clearing Company Limited take no responsib ility for the
contents of this Prospectus, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoever for any loss h owsoever arising from or in
reliance upon the whole or any part of the contents of this Prospectus.
A copy of this Prospectus, having attached thereto the documents specified in the section headed “Documents Delivered to the Registrar of Companies i n Hong Kong and Available
on Display” in Appendix V to this Prospectus, has been registered by the Registrar of Companies in Hong Kong as required by Section 342C of the Companies (Winding Up and
Miscellaneous Provisions) Ordinance, Chapter 32 of the Laws of Hong Kong. The Securities and Futures Commission of Hong Kong and the Registrar of Comp anies in Hong Kong
take no responsibility as to the contents of this Prospectus or any other documents referred to above.
The Offer Price will be HK$20.39 per Offer Share, unless otherwise announced. Investors applying for the Hong Kong Offer Shares must pay, on applicati on, the Offer Price of
HK$20.39 for each Offer Share together with brokerage fee of 1.0%, SFC transaction levy of 0.0027%, Stock Exchange trading fee of 0.00565%, and AFRC tr ansaction levy of
0.00015%.
The obligations of the Hong Kong Underwriters under the Hong Kong Underwriting Agreement are subject to termination by the Sole Sponsor-Overall Coor dinator (for itself and
on behalf of other Overall-Coordinators and the Underwriters) if certain events occur prior to 8:00 a.m. on the Listing Date. Please refer to the secti on headed “Underwriting” in
this Prospectus.
Prior to making an investment decision, prospective investors should consider carefully all of the information set out in this Prospectus, includin g the risk factors set out in the section
headed “Risk Factors.”
The Offer Shares have not been and will not be registered under the U.S. Securities Act or any state securities law in the United States and may be offered and sold only (a) in
the United States to QIBs in reliance on Rule 144A or another exemption from, or in a transaction not subject to, the registration requirements under th e U.S. Securities Act and
(b) outside the United States in offshore transactions in accordance with Regulation S.
ATTENTION
We have adopted a fully electronic application process for the Hong Kong Public Offering. We will not provide printed copies of this prospectus to the p ublic in relation to
the Hong Kong Public Offering.
This prospectus is available at the website of the Stock Exchange at www.hkexnews.hk and our website at www.genfleet.com . If you require a printed copy of this prospectus,
you may download and print from the website addresses above.
IMPORTANT
September 11, 2025


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IMPORTANT NOTICE TO INVESTORS:
FULLY ELECTRONIC APPLICATION PROCESS
We have adopted a fully electronic application process for the Hong Kong
Public Offering. We will not provide printed copies of this prospectus in relation to
the Hong Kong Public Offering.
This prospectus is available at the website of the Stock Exchange at
www.hkexnews.hk under the “ HKEXnews > New Listings > New Listing Information ”
section, and our website at www.genfleet.com . Y ou may download and print from these
website addresses if you want a printed copy of this prospectus.
To apply for the Hong Kong Offer Shares, you may:
(1) apply online via the White Form eIPO service at www.eipo.com.hk ;o r
(2) apply electronically through the HKSCC EIPO channel and cause HKSCC
Nominees to apply on your behalf by instructing your broker or custodian who
is a HKSCC Participant to give electronic application instructions via
HKSCC’s FINI system to apply for the Hong Kong Offer Shares on your
behalf. apply online via HKSCC EIPO Channel:
We will not provide any physical channels to accept any application for the Hong
Kong Offer Shares by the public. The contents of the electronic version of this
prospectus are identical to the printed prospectus as registered with the Registrar of
Companies in Hong Kong pursuant to Section 342C of the Companies (Winding Up and
Miscellaneous Provisions) Ordinance.
If you are an intermediary, broker or agent, please remind your customers, clients
or principals, as applicable, that this prospectus is available online at the website
addresses stated above.
Please refer to the section headed “ How to Apply for the Hong Kong Offer Shares ”
in this prospectus for further details on the procedures through which you can apply for
the Hong Kong Offer Shares electronically.
IMPORTANT
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Y our application through the White Form eIPO service or the HKSCC EIPO
channel must be made for a minimum of 200 Hong Kong Offer Shares and in multiples
of that number of Hong Kong Offer Shares as set out in the table below.
If you are applying through the White Form eIPO service, you may refer to the
table below for the amount payable for the number of Shares you have selected. Y ou
must pay the respective amount payable on application in full upon application for Hong
Kong Offer Shares.
If you are applying through the HKSCC EIPO channel, your broker or custodian
may require you to pre-fund your application in such amount as determined by the broker
or custodian, based on the applicable laws and regulations in Hong Kong. Y ou are
responsible for complying with any such pre-funding requirement imposed by your
broker or custodian with respect to the Hong Kong Offer Shares you applied for.
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2) on
application
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2) on
application
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2) on
application
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2) on
application
HK$ HK$ HK$ HK$
200 4,119.13 5,000 102,978.16 80,000 1,647,650.65 700,000 14,416,943.20
400 8,238.25 6,000 123,573.79 90,000 1,853,606.98 800,000 16,476,506.52
600 12,357.38 7,000 144,169.42 100,000 2,059,563.31 900,000 18,536,069.84
800 16,476.50 8,000 164,765.06 150,000 3,089,344.98 1,000,000 20,595,633.16
1,000 20,595.63 9,000 185,360.70 200,000 4,119,126.64 1,500,000 30,893,449.73
1,200 24,714.76 10,000 205,956.34 250,000 5,148,908.29 2,000,000 41,191,266.30
1,400 28,833.88 20,000 411,912.66 300,000 6,178,689.95 2,500,000 51,489,082.88
1,600 32,953.01 30,000 617,869.00 350,000 7,208,471.60 3,000,000 61,786,899.46
1,800 37,072.14 40,000 823,825.32 400,000 8,238,253.25 3,880,000
(1) 79,911,056.63
2,000 41,191.26 50,000 1,029,781.66 450,000 9,268,034.92
3,000 61,786.90 60,000 1,235,737.99 500,000 10,297,816.58
4,000 82,382.53 70,000 1,441,694.32 600,000 12,357,379.89
(1) Maximum number of Hong Kong Offer Shares you may apply for.
(2) The amount payable is inclusive of brokerage, SFC transaction levy, the Stock Exchange trading fee
and AFRC transaction levy. If your application is successful, brokerage will be paid to the Exchange
Participants (as defined in the Listing Rules) and the SFC transaction levy, the Stock Exchange trading
fee and AFRC transaction levy are paid to the Stock Exchange (in the case of the SFC transaction levy,
collected by the Stock Exchange on behalf of the SFC; and in the case of the AFRC transaction levy,
collected by the Stock Exchange on behalf of the AFRC).
No application for any other number of Hong Kong Offer Shares will be considered
and such an application is liable to be rejected.
IMPORTANT
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Should there be any changes to the dates mentioned in the following expected
timetable of the Hong Kong Public Offering, an announcement will be made and
published on the website of the Stock Exchange at www.hkexnews.hk and our website at
www.genfleet.com of the revised timetable.
Hong Kong Public Offering commences .............................. 9:00 a.m. on
Thursday, September 11, 2025
Latest time for completing electronic applications
under the White Form eIPO service through the
designated website at www.eipo.com.hk (2) .........................1 1:30 a.m. on
Tuesday, September 16, 2025
Application lists open (3) .........................................1 1:45 a.m. on
Tuesday, September 16, 2025
Latest time for (a) completing payment for
White Form eIPO applications by effecting
internet banking transfer(s) or PPS payment
transfer(s) and (b) giving electronic application
instructions to HKSCC ....................................... 12:00 noon on
Tuesday, September 16, 2025
If you are instructing your broker or custodian who is a HKSCC Participant to apply for
Hong Kong Offer Shares on your behalf, you are advised to contact your broker or custodian
for the latest time for giving such instructions, which may be different from the latest time as
stated above.
Application lists close
(3) ......................................... 12:00 noon on
Tuesday, September 16, 2025
Announcement of the level of
applications in the Hong Kong Public Offering,
the level of indications of interest in the International
Offering and the basis of allocation of the Hong Kong
Offer Shares to be published on the website of the
Stock Exchange at www.hkexnews.hk and our website
at www.genfleet.com by(4) .....................................1 1:00 p.m. on
Thursday, September 18, 2025
EXPECTED TIMETABLE (1)
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Results of allocation in the Hong Kong Public Offering to be available through a variety
of channels as described in “How to Apply for Hong Kong Offer Shares — B. Publication of
Results,” including through:
(1) the designated results of allocation website
at www.iporesults.com.hk (alternatively:
www.eipo.com.hk/eIPOAllotment ) with a
“search by ID” function from .............................1 1:00 p.m. on
Thursday, September 18, 2025 to
12:00 midnight on
Wednesday, September 24, 2025
(2) the allocation results telephone enquiry line
by calling +852 2862 8555 between 9:00 a.m.
and 6:00 p.m. on ............................ Friday, September 19, 2025,
Monday, September 22, 2025,
Tuesday, September 23, 2025 and
Wednesday, September 24, 2025
H Share certificates in respect of wholly or partially
successful applications to be dispatched or deposited
into CCASS on or before
(5)(6) ...................... Thursday, September 18, 2025
White Form e-Refund payment instructions or refund
checks in respect of wholly or partially unsuccessful
applications (or wholly successful applications, if
applicable) to be dispatched on or before
(7) .............. Friday, September 19, 2025
Dealings in H Shares on the Stock Exchange to commence at ............. 9:00 a.m. on
Friday, September 19, 2025
Notes:
(1) All dates and times refer to Hong Kong local dates and times.
(2) Y ou will not be permitted to submit your application under the White Form eIPO service through the
designated website at www.eipo.com.hk after 11:30 a.m. on the last day for submitting applications. If you
have already submitted your application and obtained an application reference number from the designated
website prior to 11:30 a.m., you will be permitted to continue the application process (by completing payment
of application monies) until 12:00 noon on the last day for submitting applications, when the application lists
close.
(3) If there is/are a tropical cyclone warning signal number 8 or above, a “black” rainstorm warning signal and/or
Extreme Conditions in force in Hong Kong at any time between 9:00 a.m. and 12:00 noon on Tuesday,
September 16, 2025, the application lists will not open or close on that day. See “How to Apply for Hong Kong
Offer Shares — E. Severe Weather Arrangements.”
EXPECTED TIMETABLE (1)
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(4) None of the websites or any of the information contained on the websites forms part of this Prospectus.
(5) Applicants being individuals must not authorize any other person to collect on their behalf. Applicants being
corporations must attend by their respective authorized representative bearing a letter of authorization from the
corporation stamped with the corporation’s chop. Evidence of identity acceptable to the H Share Registrar,
Computershare Hong Kong Investor Services Limited, must be produced at the time of collection. Uncollected
H Share certificate(s) will be sent to the addresses specified in the relevant application instructions by ordinary
post at the applicants’ own risk. See “How to Apply for Hong Kong Offer Shares — D. Dispatch/Collection
of H Share Certificates and Refund of Application Monies.”
(6) The H Share certificates will only become valid evidence of title at 8:00 a.m. on the Listing Date, which is
expected to be Friday, September 19, 2025, provided that the Global Offering has become unconditional in all
respects and the right of termination described in “Underwriting — Underwriting Arrangements and Expenses
— Hong Kong Public Offering — Grounds for Termination” has not been exercised. Investors who trade H
Shares prior to the receipt of H Share certificates or prior to the H Share certificates becoming valid evidence
of title do so entirely at their own risk.
(7) White Form e-Refund payment instructions or refund checks will be issued in respect of wholly or partially
unsuccessful applications pursuant to the Hong Kong Public Offering. Part of the applicant’s Hong Kong
identity card number, national identification document number or passport number, or, if the application is
made by joint applicants, part of the Hong Kong identity card number, national identification document
number or passport number of the first-named applicant, provided by the applicant(s) may be printed on the
refund check, if any. Such data would also be transferred to a third party for refund purposes. Banks may
require verification of an applicant’s Hong Kong identity card number, national identification document
number or passport number before encashment of the refund check. Inaccurate completion of an applicant’s
Hong Kong identity card number, national identification document number or passport number may invalidate
or delay encashment of the refund check.
The above expected timetable is a summary only. For details of the structure of the Global
Offering, including its conditions, and the procedures for applications for Hong Kong Offer
Shares, see “Structure of the Global Offering” and “How to Apply for Hong Kong Offer
Shares,” respectively.
If the Global Offering does not become unconditional or is terminated in accordance with
its terms, the Global Offering will not proceed. In such a case, our Company will make an
announcement as soon as practicable thereafter.
EXPECTED TIMETABLE (1)
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IMPORTANT NOTICE TO INVESTORS
This Prospectus is issued by us solely in connection with the Hong Kong Public
Offering and the Hong Kong Offer Shares and does not constitute an offer to sell or a
solicitation of an offer to buy any security other than the Hong Kong Offer Shares offered
by this Prospectus pursuant to the Hong Kong Public Offering. This Prospectus may not
be used for the purpose of making, and does not constitute, an offer or invitation in any
other jurisdiction or in any other circumstances. No action has been taken to permit a
public offering of the Hong Kong Offer Shares in any jurisdiction other than Hong Kong
and no action has been taken to permit the distribution of this Prospectus in any
jurisdiction other than Hong Kong. The distribution of this Prospectus for purposes of a
public offering and the offering and sale of the Hong Kong Offer Shares in other
jurisdictions are subject to restrictions and may not be made except as permitted under
the applicable securities laws of such jurisdictions pursuant to registration with or
authorization by the relevant securities regulatory authorities or an exemption therefrom.
You should rely only on the information contained in this Prospectus to make your
investment decision. The Hong Kong Public Offering is made solely on the basis of the
information contained and the representations made in this Prospectus. We have not
authorized anyone to provide you with information that is different from what is
contained in this Prospectus. Any information or representation not contained nor made
in this Prospectus must not be relied on by you as having been authorized by us, the Sole
Sponsor , the Sole Sponsor-Overall Coordinator , the Overall Coordinators, the Capital
Market Intermediaries, the Joint Global Coordinators, the Joint Bookrunners, the Joint
Lead Managers, the Underwriters, any of our or their respective directors, officers,
employees, agents, or representatives of any of them or any other parties involved in the
Global Offering.
Page
EXPECTED TIMETABLE ............................................ i v
CONTENTS ...................................................... v i i
SUMMARY ....................................................... 1
DEFINITIONS .................................................... 3 3
GLOSSARY OF TECHNICAL TERMS ................................. 4 8
FORW ARD-LOOKING STATEMENTS ................................. 6 0
RISK FACTORS ................................................... 6 2
W AIVERS AND EXEMPTION ........................................ 1 2 8
CONTENTS
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INFORMATION ABOUT THIS PROSPECTUS AND THE GLOBAL
OFFERING ..................................................... 1 3 8
DIRECTORS, SUPERVISORS AND PARTIES INVOLVED IN THE GLOBAL
OFFERING ..................................................... 1 4 3
CORPORATE INFORMATION ....................................... 1 5 2
INDUSTRY OVERVIEW ............................................ 1 5 4
REGULATIONS ................................................... 2 1 5
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE ............ 2 6 0
BUSINESS ........................................................ 3 0 1
DIRECTORS, SUPERVISORS AND SENIOR MANAGEMENT ............. 4 6 3
SUBSTANTIAL SHAREHOLDERS .................................... 4 7 9
CORNERSTONE INVESTORS ........................................ 4 8 3
SHARE CAPITAL .................................................. 4 9 8
FINANCIAL INFORMATION ........................................ 5 0 1
FUTURE PLANS AND USE OF PROCEEDS ............................ 5 5 1
UNDERWRITING ................................................. 5 5 4
STRUCTURE OF THE GLOBAL OFFERING ........................... 5 6 8
HOW TO APPLY FOR HONG KONG OFFER SHARES ................... 5 7 9
APPENDIX I ACCOUNTANTS’ REPORT ............................ I - 1
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION . . II-1
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION ........... III-1
APPENDIX IV STATUTORY AND GENERAL INFORMATION ........... I V - 1
APPENDIX V DOCUMENTS DELIVERED TO THE REGISTRAR OF
COMPANIES IN HONG KONG AND A V AILABLE
ON DISPLAY ..................................... V - 1
CONTENTS
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This summary aims to give you an overview of the information contained in this
prospectus. As this is a summary, it does not contain all the information that may be
important to you. You should read this prospectus in its entirety before you decided to
invest in the Offer Shares. There are risks associated with any investment. Some of the
particular risks in investing in the Offer Shares are set out in “Risk Factors” of this
prospectus. You should read that section carefully before you decide to invest in the Offer
Shares. In particular , we are a biotechnology company seeking to list on the Main Board
of the Stock Exchange under Chapter 18A of the Listing Rules on the basis that we are
unable to meet the requirements under Rule 8.05(1), (2) or (3) of the Listing Rules. There
are unique challenges, risks and uncertainties associated with investing in companies
such as ours. Our Core Products are the products for the purpose of satisfying the
eligibility requirements under Chapter 18A of the Listing Rule and Chapter 2.3 of the
Guide for New Listing Applicants, and are in the early stages of clinical development. We
may continue to incur substantial costs and expenses in relation to research and
development activities for the Core Products, and the Core Products may not be
successfully developed or marketed. Your investment decision should be made in light of
these considerations.
OVERVIEW
Founded in 2017, we are a biopharmaceutical company focused on developing novel
treatment options in the fields of oncology, covering different lines of treatments of multiple
solid tumors, as well as autoimmune and inflammatory diseases. As of the Latest Practicable
Date, we had established a product pipeline consisting of eight product candidates with five
under clinical development, including two Core Products — GFH925 and GFH375.
GFH925 (fulzerasib , marketed under the brand name Dupert
®), an in-house discovered
new drug, has been approved for commercialization in China for the treatment of advanced
non-small cell lung cancer (“ NSCLC ”), and it was China’s first and globally the third approved
selective inhibitor of Kirsten rat sarcoma (“ KRAS ”) G12C. We retain all rights, including
conducting R&D, manufacturing and commercialization of GFH925 globally outside of the
Greater China, and we have out-licensed all rights related to GFH925 in the Greater China. We
are currently conducting Phase II stage of KORCUS trial in the EU for GFH925/cetuximab
combination therapy as a first-line treatment of NSCLC. GFH375 is an orally bioavailable
small molecule inhibitor of KRAS G12D. We have initiated the Phase II part of a Phase I/II
clinical trial in patients with advanced solid tumors harboring the KRAS G12D mutation in
China. In addition to our Core Products, we aim to further diversify our pipeline portfolio
beyond our RAS matrix, as exemplified by GFS202A , an in-house developed bispecific
antibody targeting GDF15 and IL-6. Our pipeline also includes GFH312, an in-house
developed potent small molecule that targets receptor interacting serine/threonine-protein
kinase 1 (“ RIPK1 ”) and inhibits its kinase activity. We have obtained NMPA ’s approval to
conduct a Phase II clinical of GFH312 for the treatment of primary biliary cholangitis (“ PBC”)
in China. Our diversified pipeline portfolio is a natural outcome of our established research and
development platforms spanning target discovery, molecular discovery and evaluation,
translational science and global clinical development, augmented by our expertise in key
chemistry, manufacturing and controls (“ CMC”) aspects including formulation research and
quality analysis.
WE MAY NOT BE ABLE TO SUCCESSFULLY DEVELOP AND/OR MARKET
OUR CORE PRODUCTS.
SUMMARY
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The following chart summarizes the development status of our drug candidates as of Latest Practicable Date.
Compound Target Route of
administration Indication Pre-Clinical IND Phase I Phase II Phase III NDA Key Regulatory
Authority
Expected Upcoming
Milestone
Commercial
Rights Partnership
Oncology: RAS-Focused
GFH925 KRAS G12C Oral
Oral
Oral
Injection
Injection
Injection
Oral
advanced stage
NSCLC
(1st line, combo)(1)
FDA, EMA(2) 2025Q4
Enter Phase III
Global
(outside of
Greater China)
GFH375 KRAS G12D
advanced stage
PDAC, NSCLC
and CRC(3)
NMPA 2025Q4
Enter Pivotal trials Greater China
GFH276 Pan-Ras advanced stage
Solid tumors / 2025H2
IND Approval Global
GFS784 ADC
(new payload)
advanced stage
Solid tumors / 2026Q1
IND submission Global
Oncology: Others
GFS202A GDF15 / IL-6 Cachexia NMPA 2026H2
Enter Phase II Global
GFH009 CDK9 advanced stage
AML(4) NMPA 2025H2
Enter Pivotal Trial Greater China
GFH018 TGF-βR1 advanced stage
Various solid
tumors
NMPA, Taiwan FDA,
TGA(5) * Global
2026H1
Enter Phase II(6)
Immunology
OralGFH312 RIPK1
PBC NMPA Global
NSCLC: non-small cell lung cancer
CRC: colorectal cancer
AML: acute myeloid leukemia
PAD: peripheral artery disease
IC: intermittent claudication PDAC: pancreatic ductal adenocarcinoma
PBC: primary biliary cholangitis
= Core Products
*: Currently assessing the competitive landscape and formulating future clinical development plan.
ADC: antibody drug conjugate
*PAD with PC TGA, FDA(7) Global
SUMMARY
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Notes:
(1) Cetuximab used in the clinical trials of GFH925/cetuximab combination was provided by Merck without charge, pursuant to the Merck Agreement. For additional information,
please see “Business — Major Collaboration and Licensing Arrangements — Merck Agreement.” The Merck Agreement only provided for supply of cetuximab used in the EU
clinical trials. Cetuximab received regulatory approval for the treatment of patients with EGFR- expressing, RAS wild-type metastatic CRC in the U. S. and EU in 2004.
Cetuximab received regulatory approval for the treatment of patients with squamous cell cancer of the head and neck in the U.S. in 2006 and EU in 2004.
(2) Phase Ib and II clinical trials of the GFH925/cetuximab combination were conducted in the EU. We plan to apply for a Phase III clinical trial of the GF H925/cetuximab
combination in the United States and had a pre-IND meeting with the FDA in February 2025 regarding our planned IND application. We also plan to submit a c linical trial
application for a Phase III clinical trial of the GFH925/cetuximab combination in selected member states within the jurisdiction of the EMA.
(3) We granted V erastem an option to acquire an exclusive license to develop and commercialize GFH375 in territories outside of Greater China within t he specified option exercise
period. In January 2025, V erastem exercised the option to acquire an exclusive license to develop and commercialize GFH375 in territories outside of Greater China.
(4) We granted SELLAS an exclusive (even to ourselves), sublicensable and royalty-bearing right and license to develop, manufacture and commercial ize GFH009 across all
therapeutic and diagnostic uses worldwide outside of Greater China.
(5) The clinical trial of GFH018 was a single trial with a single protocol conducted at different locations.
(6) We have completed a Phase I clinical trial for GFH312 in healthy participants in China. We submitted an IND application for a Phase II clinical trial of GFH312 for the treatment
of PBC to the NMPA in March 2025 and obtained NMPA’s approval in May 2025. We plan to initiate a Phase II clinical trial of GFH312 for the treatment of PBC in the first
half of 2026.
(7) We have completed a Phase I clinical trial for GFH312 in healthy participants in Australia, and we have no plans for subsequent clinical trials in Au stralia. In July 2022, we
submitted an IND application including results of the Phase I clinical trial in Australia to the FDA for a Phase II clinical trial of GFH312 in patients w ith PAD with IC. The
FDA granted our IND application in August 2022, based on the results of the Phase I clinical trial in Australia.
SUMMARY
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CORE PRODUCTS
Overview of GFH925
Our Core Product GFH925, also known as fulzerasib and marketed in China under the
brand name Dupert ®, is an in-house discovered, small molecule selective inhibitor of the
KRAS G12C protein. Having received the NDA approval from the NMPA as a Class 1 new drug
in August 2024 for the second or later-line treatment of NSCLC harboring the KRAS G12C
mutation, it is China’s first and globally the third approved selective inhibitor of KRAS G12C.
GFH925 received the breakthrough therapy designation (“ BTD”) for advanced NSCLC and
was conferred the priority review status by the NMPA, and received marketing approval in
merely approximately three years after the NMPA cleared the IND approval in July 2021,
underscoring its recognized competitive advantages over existing therapeutic options. GFH925
also received the BTD from the NMPA in May 2023 as a third-line treatment for advanced
colorectal cancer (“ CRC”) harboring the KRAS G12C mutation. We anticipate that GFH925
would qualify for negotiation for inclusion in 2026 National Reimbursement Drug List
(“NRDL ”), because GFH925 is China’s first and globally the third approved selective inhibitor
of KRAS G12C and KRAS G12C-mutant NSCLC has substantial patient population in China.
With over 15 years of patent term remaining for GFH925 as of the Latest Practicable Date, we
anticipate to realize commercial returns from GFH925 to fuel our future growth.
Clinical results of GFH925 as a monotherapy have demonstrated promising safety and
efficacy profile. For instance, in the single arm registrational Phase II clinical trial that
supported the NDA approval, GFH925 was generally well tolerated and demonstrated
encouraging antitumor activity in NSCLC patients harboring the KRAS G12C mutation.
According to its approved label in China, as of the data cut-off date of December 13, 2023, the
confirmed objective response rate (“ ORR”) was 49.1%, and the disease control rate (“ DCR”)
was 90.5% in 116 patients. The median progression-free survival (“ PFS”) was 9.7 months, and
the median overall survival (“ OS”) was 13.3 months. The median duration of response
(“DoR”) was not reached. GFH925 also demonstrated a favorable overall safety profile with
absence of Grade 3 or above QT interval prolongation or renal impairment observed in
FDA-approved KRAS G12C inhibitors based on reported data, which are critical measurements
for cardiac safety and drug clearance. For details, see “Business — Core Product GFH925: A
Small Molecule Inhibitor of KRAS G12C — Summary of Clinical Trials.”
We are advancing overseas clinical development of GFH925 to unleash its therapeutic
potential, including a Phase Ib/II clinical trial for the first-line treatment of advanced NSCLC
as a combination therapy with cetuximab, an antibody drug targeting epidermal growth factor
receptor (“ EGFR ”), in countries within the EMA jurisdiction. As EGFR is situated upstream
of RAS proteins in the signaling pathway and involved in switching on RAS proteins, we
reasoned that the combination therapy may achieve synergistic effects in damping the
EGFR-RAS pathway, which is critical for cell growth. We independently developed
GFH925/cetuximab combination therapy and its clinical trial design without any involvement
or contribution from our partner in China in the study design, protocol development, or trial
operations. The combination therapy is among the first of its kind to co-target KRAS G12C and
EGFR in terms of the clinical development status. We have been conducting the
GFH925/cetuximab combination trial (“ KROCUS Trial”) independently in Europe and have
SUMMARY
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--- page 14 ---
not relied on or used, and does not intend to rely on or use, any data generated from the clinical
studies of the same combination therapy in China. Apart from incorporating certain publicly
available data or authorized information (authorized for use in a clinical trial application under
the Innovent Agreement) on the monotherapies of GFH925 and cetuximab (including the
dosage, safety and efficacy data of the Phase I clinical trial of GFH925 in China conducted by
Innvonent, as well as the chemical nature, approved indication and dosage regime of
cetuximab) in our ex-China IND applications — as required under the EMA and FDA
regulatory frameworks for combination studies — we have not relied on any research and
development activities conducted by Innovent or other third parties. In addition, in advancing
the R&D of GFH925 in ex-Greater China regions, we have not relied on or used — and do not
intend to rely on or use — any data generated from Innovent’s or other third parties’ clinical
studies of the same combination therapy in China.
Interim results from the Phase Ib/II clinical trial in Europe provide preliminary evidence
of the synergetic effect of GFH925 and cetuximab, which leads to promising antitumor efficacy
compared to GFH925 as a monotherapy or to the current treatment regimens with
chemotherapy drugs or PD-(L)1 drugs alone or in combination with chemotherapy. Following
completion of the Phase Ib safety confirmation trial and pursuant to the clinical trial protocol,
all data review team members, consisting of principal investigators, the CRO medical
monitor
(1) and we as the clinical trial sponsor, collectively reviewed the clinical data from the
Phase Ib trial, and collectively confirmed that the selected dosage of GFH925 is safe, and
collectively agreed that the Phase II trial may proceed. The primary endpoints of the Phase Ib
were reached and safety confirmation of Phase Ib trial was completed by the data review team,
as required by the clinical trial protocol. We anticipate completing the Phase II trial in the
fourth quarter of 2025. We plan to leverage the clinical results in Europe to apply for a Phase
III clinical trial in the United States and Europe to evaluate the safety and efficacy of the
GFH925/cetuximab combination therapy. We had a pre-IND meeting with the FDA in February
2025 regarding our planned IND application for a Phase III clinical trial. Once approved, we
plan to initiate the Phase III clinical trial in the fourth quarter of 2025.
NSCLC presents large addressable markets, and we view GFH925 as well-positioned to
capture the considerable market opportunities. However, we may face uncertainties in clinical
trial development which are subject to a variety of factors, including satisfactory safety and
efficacy results from clinical trials, successful enrollment of patients, performance of CROs
and other parties involved in clinical trial development and others. For more details, please see
“Risk Factors — Risks Relating to the Development, Clinical Trials and Regulatory Approval
of Our Pipeline Products — Our business and financial prospects depend substantially on the
success of our pipeline products. If we are not able to successfully complete clinical
development, obtain regulatory approval and commercialize our pipeline products, including
our Core Products, or experience delays in doing so, our business prospects could be adversely
affected.”
Note:
(1) A CRO medical monitor is an expert consultant to clinical trial sponsor and project teams that provides
guidance and oversight the essential components of clinical trial planning and execution. Here, the CRO
medical monitor is the “Supplier G” referenced and described in “Business — Our Suppliers.”
SUMMARY
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--- page 15 ---
Addressable Markets and Competitive Landscape of GFH925
RAS drug market is increasingly competitive with major players actively expanding their
RAS matrix. One of the most common mutations in the KRAS gene is G12C, accounting for
approximately 15% of all KRAS mutations, and it is also the most prevalent variant of KRAS
mutations in NSCLC. The KRAS G12C mutation occurs in approximately 13% of NSCLC and
in 3% to 4% of CRC.
GFH925 (fulzerasib) was the first KRAS G12C inhibitor drug that received approval for
commercialization in China. Globally, there were four other KRAS G12C inhibitor (adagrasib,
sotorasib, garsorasib and glecirasib) drugs that have been approved as of the Latest Practicable
Date. Among them, garsorasib, glecirasib and fulzerasib received approval for
commercialization in China as of the same date. As of Latest Practicable Date, there were more
than 20 KRAS G12C inhibitor candidates being clinically developed globally. With the
continuous market penetration of the commercialized KRAS G12C inhibitor drugs and
development of new drugs, the global KRAS G12C inhibitor drug market is expected to grow
rapidly from US$489.1 million in 2024 to US$3,490.7 million in 2033 with a CAGR of 24.4%.
The global incidence of NSCLC increased from 1,937.6 thousand in 2019 to 2,203.5
thousand in 2024, and is expected to further increase to 2,761.6 thousand in 2033. In China,
the incidence of NSCLC increased from 830.2 thousand in 2019 to 946.7 thousand in 2024, and
is expected to further increase to 1,119.3 thousand in 2033. KRAS G12C mutation alone is
present in approximately 13% of all NSCLC cases. The global incidence of CRC increased
from 1,849.1 thousand in 2019 to 2,005.2 thousand in 2024, and is expected to further increase
to 2,472.6 thousand in 2033. In China, the incidence of CRC increased from 477.1 thousand
in 2019 to 542.4 thousand in 2024, and is expected to further increase to 642.0 thousand in
2033. KRAS G12C mutation alone appears in approximately 3-4% of the CRC incidence. For
details, see “Business — Core Product GFH925: A Small Molecule Inhibitor of KRAS G12C
— Market Opportunity and Competition.”
We are currently focused on the research and development of GFH925 in the Ex-China
Territory (i.e. EU and the U.S.) and have not yet formulated a detailed commercialization plan.
However, we currently expect GFH925 to be positioned with a competitive pricing strategy in
the overseas markets with other approved KRAS G12C inhibitor drugs, leveraging production
cost efficiencies anticipated from our second-generation manufacturing process. The pricing of
GFH925 outside of Greater China may be affected by differences in national healthcare
systems, including pricing mechanisms, insurance reimbursement structures, purchasing
power, and R&D expenditures. The pricing of GFH925 in the EU and U.S. is expected to by
higher than that in China.
SUMMARY
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KRAS G12C Inhibitor Drugs Approved Globally
Brand
Name
Generic
Name Company Indication Treatment
Line
Nature of Drug
Program First Approval Time Route of
Administration Efficacy Safety Treatment
schedules
Annual Cost(1)(2)
(thousand USD)
Annual
Sales
(2023)
Reimbursement
coverage
༺Ьत Fulzerasib Innovent/GenFleet
KRAS G12C
mutated
advanced
NSCLC adult
patients
2L+ Mono 2024/08/21 (NMPA) oral
ORR 49.1%
DCR 90.5%
mPFS 9.7 months
OS 13.3 months
SAE 14.0%,
TRAEs led to dose
reduction 18.3%,
drug interruption
32.6%, permanent
discontinuation 2.7%
600 mg, BID 31.0 – No
τ˙ྐྵ Garsorasib Chia Tai
Tianqing/Inventisbio
KRAS G12C
mutated
advanced
NSCLC adult
patients
2L+ Mono 2024/11/08 (NMPA) oral
ORR 52.0%
DCR 88.6%
mPFS 9.1 months
OS 14.1 months
TRAEs 95.9%
TRAEs led to dose
reduction 30.1%,
drug interruption
41.5%, permanent
discontinuation 0%
600 mg, BID 35.0 – No
Ў๿௱ Glecirasib Jacobio/Allist
KRAS G12C
mutated
advanced
NSCLC adult
patients
2L+ Mono 2025/5/20 (NMPA) oral
ORR 49.6%
DCR 86.3%
mPFS 8.2 months
OS 13.6 months
TRAEs 97.5%
TRAEs led to dose
reduction 37.8%,
drug interruption
18.5%, permanent
discontinuation 5%
800 mg, QD NA – No
Krazati Adagrasib BMS
KRAS G12C
mutated locally
advanced or
metastatic
NSCLC adult
patients
2L+ Mono 2022/12/12 (FDA)
2024/01/05 (EMA)
oral
ORR 42.9%
mPFS 6.5 months
OS 12.6 months
TRAEs led to dose
reduction 28%,
drug interruption
77%, permanent
discontinuation 13%
600 mg, BID 280.0 126 million
USD
KRAS G12C
mutated
metastatic
CRC
2L Combo with
cetuximab 2024/06/21 (FDA)
ORR 34%
DCR 85.1%
mPFS 6.9 months
mOS 15.9 months
TRAEs led to dose
reduction 35%,
drug interruption
62%, permanent
discontinuation
2 patients
(about 0.02%)
KRAS G12C
mutated
metastatic
CRC
2L combo with
panitumumab 2025/1/17 (FDA)
ORR 26%
mPFS 5.6 months
mOS Not Reached
TRAE 45.3%
Lumakras Sotorasib Amgen
KRAS G12C
mutated locally
advanced or
metastatic
NSCLC adult
patients
2L+ Mono
2021/05/28 (FDA)
2022/01/06 (EMA)
2022/01/20 (PMDA)
oral
ORR 37.1%
DCR 80.6%
mPFS 6.3 months
mOS 12.5 months
SAE 14.0%,
TRAEs led to dose
reduction 5%,
drug interruption
34%, permanent
discontinuation 9% 960 mg, QD 266.9
350
million
USD
Notes:
(1) The significant differences of annual costs of approved KRAS G12C inhibitor drugs in China and U.S. are due
to the differences in healthcare systems between the two countries, including pricing mechanism, insurance
payment system, spending power and R&D costs.
(2) The annual cost of each drug is calculated by multiplying the recommended daily dosage (as specified in the
package insert) by the unit pharmacy cash price per dose (from publicly available drug price charged to
consumers, excluding discounts) to give the daily cost, then multiplying this daily cost by the treatment
duration, which is based on clinical PFS data. The same calculation is applied to all approved KRAS G12C
inhibitor drugs.
While the first commercially-available KRAS G12C inhibitors have shown promising
efficacy results, drug resistance and certain side effects including gastrointestinal toxicity have
been observed in their clinical applications. GFH925, as a KRAS G12C inhibitor, is not
designed or expected to eliminate drug resistance or certain side effects, such as
gastrointestinal toxicity, associated with other approved KRAS G12C inhibitor drugs. For
details, see “Industry Overview — Overview of RAS Drug Market — Overview of KRAS
G12C Drugs.”
Our clinical development of GFH925 has been focused on the GFH925/cetuximab
combination therapy as a first-line treatment for patients with advanced NSCLC with KRAS
G12C mutations.
SUMMARY
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Overview of GFH375
GFH375 is an orally bioavailable small molecule inhibitor of KRAS G12D. KRAS G12D
is the most prevalent oncogenic KRAS variant that lacks approved treatment options. It is
found in various cancer types, including approximately 35% of pancreatic cancer, 12% of CRC
and 4% of NSCLC.
We have overcome the technical challenges to discover GFH375, a small molecule
inhibitor that targets KRAS G12D in both “on” and “off” states with a strong, low
nanomolar-level binding affinity, as demonstrated in our preclinical studies. GFH375 has also
demonstrated preclinical antitumor activity in controlling tumor growth in different animal
models. Furthermore, GFH375 differentiates itself from many other product candidates
currently under development for KRAS G12D in terms of route of administration. Formulated
as a once-daily, orally available treatment instead of requiring infusions, we believe GFH375
could potentially ease repeated drug administration, improve patient compliance, and therefore
potentially increase the overall efficacy of the treatment regimen. Notably, multiple cases of
antitumor activities have been observed at starting doses.
We are conducting a Phase I/II clinical trial of GFH375 in China to evaluate its safety and
efficacy in treating advanced solid tumors with the KRAS G12D mutation and a Phase II
clinical trial of GFH375 in China to evaluate its safety and efficacy in treating PDAC with the
KRAS G12D mutation. As of the data cut-off date of January 17, 2025, based on the completed
Phase I clinical trial results, where 33 patients were enrolled, no death or DLT occurred, and
a total of 10 patients experienced Grade 3 or higher TRAEs, which included diarrhea, increased
aspartate aminotransferase, increased gamma-glutamyl transferase, fatigue, decreased white
blood cell count, decreased neutrophil count, liver dysfunction, anemia, hypokalemia and
syncope. For more details, please refer to “Business — Our RAS Matrix Pipeline Products —
GFH375: A Small Molecule Inhibitor of KRAS G12D.” Moreover, 600 mg QD has been
recommended as the phase II dose (RP2D) for the phase II portion which started in February
2025.
We have granted to our partner V erastem an exclusive license to develop and
commercialize GFH375 in territories outside of Greater China. V erastem initiated a Phase I/IIa
clinical trial of GFH375 in patients with advanced solid tumors harboring the KRAS G12D
mutation in the U.S. in June 2025.
Addressable Markets and Competitive Landscape of GFH375
The KRAS G12D mutation accounts for approximately 29% of all KRAS mutations,
making it the most prevalent variant in human cancers. The KRAS G12D mutation is
particularly frequent in pancreatic cancer (approximately 35%), CRC (approximately 12%) and
NSCLC (approximately 4%). Compared to the KRAS G12C mutation, the KRAS G12D
mutation causes more disruption of intrinsic GTPase activity, resulting in a higher proportion
of active GTP-bound KRAS in tumor cells.
SUMMARY
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--- page 18 ---
As of the Latest Practicable Date, there was no approved KRAS G12D inhibitor drug
globally. GFH375 is one of the most advanced orally bioavailable inhibitors of KRAS G12D
in terms of development status as of the same date. There were 17 KRAS G12D inhibitor
candidates being clinically developed globally as of Latest Practicable Date. For details of the
targeted markets of GFH375, see “Industry Overview — Overview of RAS Drug Market —
Overview of KRAS G12D Drugs.”
Our clinical development of GFH375 has been focused on GFH375 as a second or later
line treatment for patients with PDAC, NSCLC or CRC with KRAS G12D mutations.
RAS MATRIX PIPELINE PRODUCTS
 GFH276 is a pan-RAS (on) molecular glue. We believe that pan-RAS approaches
are differentiated from pan-KRAS approaches that aim to address multiple KRAS
mutations at the same time. GFH276 demonstrated potential anti-proliferative
activity in cell lines that harbor various mutations in the RAS family members or in
cell lines with KRAS G12C that are conferred resistance to sotorasib and adagrasib.
We believe GFH276 may exhibit a potentially lower efficacious dose and better
tolerability in humans, which underscores the competitiveness of GFH276 as a
pan-RAS inhibitor and its potential to benefit the patient population in need.
Additionally, available clinical results suggest that some pan-RAS inhibitors may be
associated with adverse effects that are related to their comprehensive blockage of
RAS proteins. Therefore, pan-RAS inhibitor drug candidates with improved safety
profiles may have enhanced therapeutic potentials. For details, see “Industry
Overview — Overview of RAS Drug Market — Overview of Pan-RAS Drugs” and
“Business — Our RAS Matrix Pipeline Products — GFH276: A Pan-RAS Molecular
Glue.”
 GFS784 is a new molecular modality leveraging synergistic effect of large and small
molecules, which we call functional antibody synergistic conjugate (“ FAScon ”),
featuring a combination of antibody and small molecule drug targeting separate
components of the same signaling pathway. GFS784 is our leading FAScon
candidate, consisting of an antibody that blocks EGFR, an upstream cell surface
receptor of RAS signal pathway, and a small molecule pan-RAS inhibitor. We
believe this design has the potential to deliver promising clinical benefits. For
details, see “Business — Our RAS Matrix Pipeline Products — GFS784: EGFR-
Pan-RAS Functional Antibody Synergetic Conjugate.”
SUMMARY
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--- page 19 ---
SELECTED OTHER PIPELINE PRODUCTS
 GFH312 is an in-house developed inhibitor of the kinase RIPK1. RIPK1 is a master
regulator of the cellular decision between pro-survival signaling and death in response to
inflammatory and pro-death stimuli. The unique hydrophobic pocket in the allosteric
regulatory domain of RIPK1 has enabled the development of highly selective small
molecules of its kinase activity. As RIPK1 plays an important role in driving cell death
and inflammation, RIPK1 inhibitors potentially possess broad therapeutic applications for
the treatment of a wide range of human diseases, such as autoimmune diseases,
inflammatory disorders and neurodegenerative conditions.
The prevalence of PBC reached 1.2 million globally and 291.1 thousand in China in 2024,
according to Frost & Sullivan. The global PBC drug market grew from US$1,004 million
in 2019 to US$1,147.3 million in 2024, and is expected to further grow to US$1,542.2
million in 2033. China’s PBC drug market grew from US$235.0 million in 2019 to
US$232.4 million in 2024, and is expected to further grow to US$284.0 million in 2033.
We believe that GFH312 possesses the therapeutic potential to alleviate the root cause of
PBC. For details of the targeted markets of GFH312, see “Industry Overview —
Overview Of Ripk1 Drug Market.”
We completed a Phase I clinical trial for GFH312 in healthy participants in Australia and
China, respectively, achieving the predefined safety and pharmacokinetic objectives.
After reviewing results from the Australian Phase I clinical trial, the FDA has granted us
approval to commence a Phase II clinical trial of GFH312 for PAD with IC. We are also
planning to investigate GFH312 for the treatment of PBC in China. We submitted an IND
application for a Phase II clinical trial of GFH312 for the treatment of PBC to the NMPA
in March 2025 and obtained NMPA’s approval in May 2025. We plan to initiate a Phase
II clinical trial of GFH312 for the treatment of PBC in the first half of 2026.
 GFS202A is a novel bispecific antibody targeting both GDF15 and IL-6, two important
cytokines that play crucial roles in inflammatory processes, metabolic regulation, cancer
progression and cachexia. Cachexia is a common, life-threatening wasting condition that
can significantly impact quality of life in affected patients with cancer or other types of
chronic diseases. As of the Latest Practicable Date, there had been no FDA- or
NMPA-approved drug specifically for the treatment of cachexia, according to Frost &
Sullivan. As overexpression of GDF15 and IL-6 is associated with cachexia development
and poor survival, we believe a dual neutralization of GDF15 and IL-6 may potentially
achieve a better activity compared to targeting GDF15 alone. For details, see “Business
— Other Pipeline Products — GFS202A: A Novel Bispecific Antibody Targeting GDF15
and IL-6 as a Potential Treatment of Cachexia.”
SUMMARY
–1 0–


--- page 20 ---
 GFH009 is a selective small molecule compound that targets CDK9 and inhibits the
activity of the CDK9/cyclin T1 complex. CDK9, a serine/threonine kinase, plays crucial
roles in tumor growth. GFH009 is designed as a potential treatment for multiple types of
hematological malignancies. It received from the FDA the orphan drug designation
(“ODD”) and the fast track designation (“ FTD”) in October 2023 and January 2024,
respectively, for the treatment of acute myeloid leukemia (“ AML”). We also forged
collaborations with SELLAS, which has significant expertise in hematological
malignancies and solid tumors, on GFH009.
 GFH018 is a small-molecule inhibitor of TGF- /H9252R1. Elevated expression of TGF- /H9252
signaling genes is linked to various solid tumors. Results from a Phase I clinical trial in
patients with advanced solid tumors in Mainland China demonstrated potentially
favorable safety and preliminary efficacy profiles of GFH018.
STRENGTHS
We believe the following strengths differentiate us from our competitors:
 Comprehensive innovative drug portfolio addressing RAS
 Core Product GFH925, the first approved selective inhibitor of KRAS G12C in
China with a favorable safety and efficacy profile and considerable market potential
 Core Product GFH375, an orally bioavailable small molecule inhibitor of KRAS
G12D with the potential to target both active and inactive forms of KRAS
 Key Product GFH312, a small molecule inhibitor of RIPK1 that possesses broad
therapeutic applications for the treatment of autoimmune diseases, inflammatory
disorders and neurodegenerative conditions
 A powerhouse with a suite of integrated research and development platforms, and
CMC expertise to accelerate drug development and facilitate cost control
 Seasoned discovery and development leadership team with successful first-to-
market drug experiences
STRATEGIES
We plan to pursue the following significant opportunities and execute our key strategies
accordingly:
 Advance our Core Products through global clinical development
 Advance and replenish our other innovative product pipeline with a focus on the
comprehensive RAS pathway product matrix
 Execute global strategy through broad and diverse collaborations in
commercialization arrangements, business development and pipeline development
SUMMARY
–1 1–


--- page 21 ---
RESEARCH AND DEVELOPMENT
As of the Latest Practicable Date, 48 members of our R&D team had obtained advanced
degrees, including 13 members with doctorate degrees and 35 members with master’s degrees.
Our R&D team has strong expertise, deep understanding and broad development experience,
and is led by a team of world-class scientists with years of drug development experience. Our
core R&D personnel consists of six members covering the fields of chemistry, biology,
pharmacology and medicine. All of our core R&D personnel have been working in the
pharmaceutical industry for over 15 years. Our drug discovery team members also have
expertise in the fields of chemistry, biology, pharmacology and medicine, which support our
product development. For details, see “Business — Research and Development — R&D team.”
We aspire to leverage our industry experience and established R&D capabilities to
develop new and effective treatment options in the fields of oncology, autoimmune and
inflammatory diseases. During our endeavor, we have established and leveraged a proven,
integrated research and development platform spanning target discovery, molecular discovery
and evaluation, translational science and clinical development. Our technological capabilities
include discovery of original molecular structures and new molecular entities, investigation of
molecular process routes and quality standards, as well as exploration of clinical drug
combination development paths. Combining these internally accumulated capabilities and
external resources of our collaborators and service providers, we have rendered our pipeline
products among the frontrunners in both China and the global market.
In line with industry practice, we collaborate with contract research organizations
(“CROs ”) to conduct and support our preclinical and clinical studies. We select our CROs by
weighing various factors, such as their business focus, capabilities and overall market
recognition.
For the years ended December 31, 2023 and 2024 and the four months ended April 30,
2024 and 2025, we recorded R&D expenses of RMB312.7 million, RMB332.1 million and
RMB142.3 million and RMB69.8 million, respectively, representing 86.2%, 85.1%, 91.1% and
74.7% of our total operating expenses (defined as the sum of R&D expenses and administrative
expenses) in the corresponding periods, respectively. We anticipate to continue to significantly
invest in our R&D efforts, since we plan to expand the indications and continue the clinical
development of our Core Products, advance more pipeline candidates along clinical trials and
conduct additional preclinical studies.
For the years ended December 31, 2023 and 2024 and four months ended April 30, 2024
and 2025, we recorded major items of research and development costs attributable to our Core
Products, namely GFH925 and GFH375, of RMB121.1 million, RMB143.3 million and
RMB78.1 million, and RMB27.2 million, respectively, representing 38.7%, 43.1%, 54.9% and
39.0% of our total research and development costs in the corresponding periods, respectively.
For details, see “Financial Information — Research and Development Costs.”
SUMMARY
–1 2–


--- page 22 ---
CHEMISTRY, MANUFACTURING & CONTROLS
As of the Latest Practicable Date, our CMC team consisted of 15 professionals with
extensive experience in process development, production and quality management from
well-known biopharmaceutical and pharmaceutical companies. Our CMC team members have
on average approximately 11 years’ experience. Our CMC team specialized in preclinical and
clinical support throughout the drug development process. The CMC function in our Company
plays a critical role in drug development. It is responsible for developing safe, robust, and
economically sound production processes for our drug substances and drug products, and
ensuring their quality meets regulatory requirements.
We have established CMC capabilities that covers key aspects from the design of
synthetic routes for preclinical candidates to process development and quality control in
clinical development. We have in-depth expertise in areas including small molecule production
process development, dosage form selection, formulation determination, formulation process
development, drug quality control strategies, development and validation of quality control
methodologies, non-GMP kilogram-scale pilot production, and NDA-stage process validation.
Our CMC functions facilitate a smooth drug development and enables cost control. In
particular, we develop suitable process and ensure quality control according to applicable drug
registration regulations at early stages of product development. This strategy enables us to
avoid detours in subsequent development stage resulted from CMC issues that could have been
addressed earlier in the process, therefore may improve the overall efficiency of our research
and development efforts. In addition, our CMC process development capabilities allow us to
device efficient synthetic routes and establish measures to ensure consistent and reliable
production, thereby contribute to cost control and efficient use of resources. We are able to
significantly lower the manufacturing cost of GFH925 by optimizing the process route, and we
believe our CMC expertise also facilitated GFH925 to receive marketing approval in China in
merely approximately three years after it obtained IND approval. We are also actively
developing the second-generation manufacturing process for GFH925, taking full
responsibility for the entire process, including vendor selection. We have engaged two vendors
to collaborate on this initiative. We anticipate that the second-generation manufacturing
process will significantly enhance the cost-efficiency of drug production. We believe that
possessing core competency in CMC expertise will enable us to ensure the safety and quality
of the drug supply while positioning us to independently pursue ex-China regulatory approvals
and capitalize on potential commercial opportunities for GFH925 once the necessary
regulatory milestones are obtained.
As of the Latest Practicable Date, we did not have in-house manufacturing facility. We
currently plan to establish our own manufacturing facilities to support the formulation
production of certain of our pipeline products. We collaborate with CDMOs to conduct and
support our preclinical and clinical trials in line with industry practice. In terms of the
involvement and contributions of each of the major CDMO partners to the development of our
product candidates, we collaborate with our CDMO partners to manufacture certain raw
materials and drug substances, such as the active pharmaceutical ingredients (“ APIs ”) of our
product candidates to supply for preclinical studies and clinical trials. We did not experience
any material product quality issues in respect of the products manufactured by our CDMO
partners during the Track Record Period.
SUMMARY
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--- page 23 ---
INTELLECTUAL PROPERTY RIGHTS
As of the Latest Practicable Date, we held 72 issued patents and 118 patent applications
(including 9 PCT applications). As of the Latest Practicable Date, we held (i) 2, 1, 1 and 8
issued patents related to GFH925 in China, the U.S., the E.U. and in other overseas
jurisdictions respectively, and (ii) 5, 4, 3, 1 and 21 patent applications related to GFH925 in
China, the U.S., the E.U., under the PCT and in other overseas jurisdictions, respectively. As
of the same date, we have not received issued patents related to GFH375, but held 2, 1, 1, 1
and 22 patent applications related to GFH375 in China, the U.S., the E.U., under the PCT and
in other overseas jurisdiction, respectively. We currently plan to file patent application related
to GFH375 in Hong Kong in the second half of 2025 and in Macau after the receipt of the
issued patent in China. As of the Latest Practicable Date, we had not received any material
concerns or inquiries from relevant competent authorities that makes us to believe that any of
the pending patent applications will be finally rejected. The following table sets forth an
overview of our material granted patents and filed patent applications in connection with our
Core Products and significant clinical and preclinical product candidates as of the Latest
Practicable Date:
Products
Name of Patent
Family (1) Jurisdiction Status
Patent
Application Grant Date
Patent
Expiration (2) Type
Owner/
Applicant Inventor (3)
GFH925 /H1118/H1118Substituted
Heterocyclic Fused
Cyclic Compound,
Preparation Method
Therefor and
Pharmaceutical Use
Thereof
China,
United
States, EPO
Granted 2020-10-28 China:
2022-8-5;
United States:
2024-8-6;
EPO:
2024-10-9
2040-10-28 Invention GenFleet,
GenFleet
Zhejiang
Fusheng Zhou,
Tao Jiang,
Chonglan Lin,
Lijian Cai,
Wan He, Jiong
Lan
China,
United
States, EPO
Pending – – Invention GenFleet,
GenFleet
Zhejiang
Polymorph of KRAS
Inhibitor,
Preparation Method
Therefor, and Use
Thereof
China,
United
States, EPO
Pending 2022-12-23 – – Invention GenFleet,
GenFleet
Zhejiang
Fusheng Zhou,
Jinzhu Zhao,
Y udong Cao,
Lun Xiong,
Rongzhen Shi,
Jiong Lan
Pharmaceutical
Composition, Use
Thereof, and
Method for Treating
Cancer
China, United
States, EPO
Pending China:
2023-03-30;
United States:
2023-03-31;
EPO:
2023-03-31
– – Invention GenFleet,
GenFleet
Zhejiang
Lili Tang, Xiang
Y u, Jingyang
Zhang,
Huizhong Hu,
Fusheng Zhou,
Y u Wang,
Jiong Lan,
Qiang Lu
Pharmaceutical
Composition, and
Preparation Method
Therefor and Use
Thereof
China, United
States
Pending 2023-9-20 – – Invention GenFleet Y uanyuan Xie,
Lina Qi, Can
Huang, Jiong
Lan, Qiang Lu
SUMMARY
–1 4–


--- page 24 ---
Products
Name of Patent
Family (1) Jurisdiction Status
Patent
Application Grant Date
Patent
Expiration (2) Type
Owner/
Applicant Inventor (3)
Method for
Preparation of
Pyrazine-
Naphthyridine
Diketones and
Intermediates
Thereof
PCT Pending 2024-8-15 – – Invention GenFleet Jinzhu Zhao,
Y udong Cao,
Lun Xiong,
Xiong Wei,
Xiangchao
Liu, Mengting
Meng,
Fusheng Zhou,
JingRong Li,
Jiong Lan,
Qiang Lu
GFH375 /H1118/H1118Pyrimidine-Fused
Ring Compound,
and Preparation
Method Therefor
and Use Thereof
China,
United States
Pending 2023-9-25 – – Invention GenFleet,
GenFleet
Zhejiang
Tao Jiang,
Fusheng Zhou,
Tao Liang,
Chonglan Lin,
Lijian Cai,
Zhubo Liu,
Xiaoming Xu,
Kai Ma,
Leitao Zhang,
Zhen Li, Jiong
Lan
GFH312 /H1118/H1118Dihydronaphthyridinone
Compound, and
Preparation Method
Therefor and
Medical Use
Thereof
China Granted 2021-2-9 2024-2-9 2041-2-9 Invention GenFleet,
GenFleet
Zhejiang
Fusheng Zhou,
Xiaoming Xu,
Leitao Zhang,
Xin Li, Lili
Tang, Jiong
Lan
United States Pending – –
Crystal Form of
RIPK1 Inhibitor,
Acid Salt Thereof,
and Crystal Form of
Acid Salt Thereof
China,
United States
Pending 2022-8-2 – – Invention GenFleet,
GenFleet
Zhejiang
Fusheng Zhou,
Y uanzhi Tao,
Jinzhu Zhao,
Jiong Lan
GFH276 /H1118/H1118Macrocyclic
Compounds, and
Preparation Method
Therefor and Use
Thereof
PCT Pending 2024-8-30 – – Invention GenFleet Jichen Zhao,
Fusheng Zhou,
Tao Liang,
Y andong Lu;
Tao Jiang;
Chonglan Lin;
Ling Peng;
Jiong Lan;
Qiang Lu
GFH009
(4) /H1118Inhibitor of Cyclin-
Dependent Kinase
CDK9
China,
United States
Granted China:
2017-4-19;
United States:
2018-1-3
China:
2020-6-19;
United States:
2021-3-23
China:
2037-4-19;
United States:
2038-1-3
Invention GenFleet,
GenFleet
Zhejiang
Gang Zhou
GFH018
(4) /H1118Benzotriazole-Derived
/H9251And
/H9252-Unsaturated
Amide Compound
Used as TGF- /H9252R1
Inhibitor
China,
United States
Granted 2017-6-8 China:
2021-2-26;
United States:
2020-2-4
2037-6-8 Invention GenFleet,
GenFleet
Zhejiang
Fei Sun, Lifang
Wu, Charles
Z. Ding,
Guoping Hu,
Jian Li,
Shuhui Chen,
Jianyu Lu
Abbreviations: PCT = Patent Cooperation Treaty; EPO = European Patent Office
SUMMARY
–1 5–


--- page 25 ---
Notes:
(1) Unless otherwise indicated, the name of patents and patent applications within the same family is the same and
is therefore disclosed once.
(2) The patent expiration date is estimated based on current filing status, without taking into account any possible
patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity
and other government fees.
(3) All the inventors of the patents and patent applications listed in this table were employees of the Group when
the related inventions were conceived, except for the patents relating to GFH009 and GFH018, because these
patents were transferred from third parties. As of the Latest Practicable Date, we have no dispute with these
inventors regarding the ownership and disposition rights of the patents and patent applications listed in this
table.
(4) The U.S. patents in connection with GFH009 and GFH018, as listed in the table, are owned by GenFleet only.
We have identified that certain issued patents in China belonging to third parties appear
to cover the chemical structure of GFH925 and may not expire before the anticipated
commercial launch of GFH925 in China. To proactively manage any potential risks from these
patents, we have entered into two license agreements with third party holders of such patents
in China, to ensure activities relating to GFH925 in target markets will not be hindered by these
patents. Pursuant to the two license agreements, we are required to make a total of RMB34.5
million to these third party patent holders, which has been fully paid as of the date of the
prospectus, and mid-teens royalties tied to the achievement of specific regulatory.
commercialization milestones and receipt of royalties of GFH925 in Greater China to one of
the patent holders. Such mid-teens royalties is contingent on our receipt of regulatory,
commercial milestone payments and royalty payments from sublicensees (Innovent is currently
the only sublicensee). As a result of such licensing agreements, we have pre-empted potential
issues over GFH925 in China with those third-party patent holders, whose patents in China
would not affect our freedom to operate GFH925 and its future commercialization in China, as
advised by our IP counsel as to the PRC intellectual property laws. We are also aware of a U.S.
patent whose claim scope is excessively broad and appears to cover the chemical structure
formed by GFH925 bonded to certain residue of KRAS protein, which is a desired functional
characteristic of GFH925. However, the U.S. patent may be subject to validity challenges, and
therefore its potential impact on the freedom to operate GFH925 in the U.S. is low. For details,
please see “Business — Intellectual Property.”
We conduct our business under the brand name of “GenFleet” and/or “˙.” As of the
Latest Practicable Date, we held five registered trademarks in Mainland China and three
registered trademarks in Hong Kong. We are also the owner of eight registered software
copyrights and one domain name. As of the Latest Practicable Date, we were not involved in
any proceedings in respect of, and we had not received notice of any claims of infringement
of, any intellectual property rights that may be threatened or pending, in which we may be a
claimant or a respondent. For for information about our intellectual properties, please see
“Business — Intellectual Property.”
SUMMARY
–1 6–


--- page 26 ---
MAJOR COLLABORATION AND LICENSING ARRANGEMENTS
We have successfully entered into multiple cooperation and licensing agreements with
domestic and international partners to accelerate the development and maximize the
commercial value of our product portfolio. For details, see “Business — Major Collaboration
and Licensing Arrangements.”
License Agreement with Innovent
On September 1, 2021, we entered into a license and option agreement (the “ GFH925
License Agreement ”) with Innovent. According to the GFH925 License Agreement, we grant
to Innovent (i) an exclusive, royalty-bearing and sublicensable license to develop and
commercialize GFH925 for the treatment, prevention or diagnosis of any disease in humans in
Mainland China, Hong Kong, Macau and Taiwan (the “ Greater China ”); and (ii) an exclusive
option (the “ Ex-China Option ”) to develop and commercialize GFH925 in the all countries
and regions in the world other than Greater China (the “ Ex-China Territory ”). Prior to
entering into the GFH925 License Agreement, we proactively identified and finalized the
arrangement details with the lead principal investigator. Innovent later supported the clinical
collaboration by expanding the trial from the eight clinical sites we initially arranged to a total
of 55 clinical sites. After signing of the GFH925 License Agreement, Innovent became the
sponsor of the GFH925X1101 trial in China and is thereafter solely responsible for the
development and commercialization of GFH925 in the Greater China region. Also, Innovent is
the marketing authorization holder (“ MAH”) of GFH925 in Greater China. However, we retain
a critical role in managing the CMC-related processes, including overseeing process
development, finalizing agreements with key stakeholders, and selecting suitable vendors to
ensure smooth trial execution. Innovent will pay our Company for the drug supply on an
ongoing basis, with payments determined by the quantity required to support the trial’s
development needs. On January 11, 2024, we further entered into a supplementary agreement
(the “ GFH925 Supplementary Agreement ,” together with the GFH925 License Agreement,
the “ Innovent Agreement ”) with Innovent. According to the GFH925 Supplementary
Agreement, both parties agreed to terminate the Ex-China Option under the GFH925 License
Agreement. We have the exclusive rights to develop, manufacture and commercialize GFH925
for any indication in the Ex-China Territory. As of the Latest Practicable Date, we had paid
US$6.0 million to Innovent under the GFH925 Supplementary Agreement. The remaining
termination fees payment of US$14.0 million will be paid in two installments by December
2026.
For additional information, please see “Business — Major Collaboration and Licensing
Arrangements — License Agreement with Innovent” and “Business — Major Collaboration
and Licensing Arrangements — Supplementary Agreement with Innovent.”
SUMMARY
–1 7–


--- page 27 ---
Collaboration and Option Agreement with Verastem
On August 24, 2023, we entered into a collaboration and option agreement (the
“Verastem Agreement ”) with V erastem, pursuant to which, on a program-by-program basis,
we granted V erastem options (the “ Verastem Option(s) ”) to acquire an exclusive license to
develop and commercialize three product candidates, including GFH375, in territories outside
of Greater China within the specified option exercise period. V erastem agreed to pay an upfront
payment, certain development costs, as well as stipulated milestone payments, option exercise
fees and royalties on future annual net sales. In January 2025, V erastem exercised the option
to acquire an exclusive license to develop and commercialize GFH375 in territories outside of
Greater China.
For additional information, see “Business — Major Collaboration and Licensing
Arrangements — Collaboration and Option Agreement with V erastem.”
License Agreement with SELLAS
On March 31, 2022, we entered into a license agreement (the “ SELLAS License
Agreement ”) with SELLAS. Pursuant to the SELLAS License Agreement, we granted
SELLAS an exclusive (even to ourselves), sublicensable and royalty-bearing right and license
to develop, manufacture and commercialize GFH009 across all therapeutic and diagnostic uses
worldwide outside of Greater China (Mainland China, Hong Kong, Macau and Taiwan).
On October 13, 2022, we entered into a clinical supply agreement supplement to the
SELLAS License Agreement (the “ SELLAS Supplementary Agreement ”) with SELLAS.
According to the SELLAS Supplementary Agreement, we will manufacture and supply
GFH009 in the applicable formulations as specified in each purchase order to SELLAS. We
will ensure that we deliver GFH009 in conformation with the specifications, and regulatory
standards (the “ Manufacturing Requirements ”). SELLAS will provide a purchase order to us
every six months, specifying the quantity, formulations, and requested delivery dates.
For additional information, please see “Business — Major Collaboration and Licensing
Arrangements — License Agreement with SELLAS” and “Business — Major Collaboration
and Licensing Arrangements — Supplementary Agreement with SELLAS.”
Collaboration and Supply Agreement with Merck
On June 30, 2022, we entered into a clinical trial collaboration and supply agreement (the
“Merck Agreement ”) with Merck Healthcare KGaA in relation to the clinical development of
the GFH925/cetuximab combination therapy for a Phase Ib/II clinical trial (i.e.,
GFH925X0201) in the European Union. According to the Merck Agreement, Merck is
obligated to provide cetuximab for the use in the clinical trial to us with a maximum number
of 3,500 vials and schedule specified in the Merck Agreement according to the clinical trial
status and subject to mutual agreement between Merck and our Company. Our Company shall
SUMMARY
–1 8–


--- page 28 ---
bear all other costs associated with the subject clinical trial. The Merck Agreement does not
affect our status as the sole sponsor of or our sole responsibility to conduct the KROCUS trial.
The Merck Agreement does not provide for a joint steering committee. The Merck Agreement
stipulates that all rights to all inventions that are directed to the combination therapy and
variants thereof, except those inventions solely relating to GFH925 or cetuximab, shall be
jointly owned by Merck and our Company. Those inventions solely relating to GFH925 or
cetuximab shall be solely owned by GenFleet or Merck, respectively.
For additional information, please see “Business — Major Collaboration and Licensing
Arrangements — Merck Agreement.”
CUSTOMERS
In 2023 and 2024 and the four months ended April 30, 2025, our revenue was mainly
generated from three customers relating to multiple performance obligations including (1)
grants of licenses to intellectual property rights, (2) the research and development services and
(3) the supply of drugs in 2024. We generally grant a credit term of 30 days to 60 days from
the first day of the following month after receipt of invoice to our customers. Neither of them
is our supplier.
To the best of our knowledge, the three customers during the Track Record Period are
Independent Third Parties. None of our Directors, their respective associates or any
shareholder who, to the knowledge of our Directors, owned more than 5% of our issued share
capital as of the Latest Practicable Date, has any interest in any of the three customers during
the Track Record Period. For additional information, please see “Business — Our Customers.”
SUPPLIERS
During the Track Record Period, our major suppliers primarily consisted of CROs and
CDMOs and we did not experience any material disputes with our suppliers. In addition, we
believe that adequate alternative sources for such supplies exist, and we have developed
alternative sourcing strategies for these supplies. We generally have credit periods of 30 days.
For the years ended December 31, 2023 and 2024 and the four months ended April 30, 2024
and 2025, our purchases from our five largest suppliers in each year/period in aggregate
amounted to RMB94.1 million, RMB114.7 million, RMB26.9 million and RMB34.0 million
respectively, representing 44.4%, 45.7%, 47.5% and 41.7% of our total corresponding
purchases, and our purchases from the largest supplier in each period accounted for 11.3%,
13.3%, 17.1% and 11.6% of our total corresponding purchases, respectively.
All of our five largest suppliers in each year/period during the Track Record Period are
Independent Third Parties. None of our Directors or any Shareholder who, to the knowledge
of our Directors, owns more than 5% of our issued share capital immediately following
completion of the Global Offering, nor any of their respective associates had any interest in any
of our five largest suppliers in each year/period during the Track Record Period. In 2023, we
engaged 5 CROs and 15 CDMOs, for which we incurred expenses of RMB52.7 million and
SUMMARY
–1 9–


--- page 29 ---
RMB86.1 million, respectively. In 2024, we engaged 5 CROs and 10 CDMOs, for which we
incurred expenses of RMB42.5 million and RMB89.4 million, respectively. The decrease in the
expenses incurred for engaging CROs and the number of engaged CDMOs were primarily due
to the changed needs of many of our R&D projects. In the four months ended April 30, 2025,
we engaged 5 CROs and 10 CDMOs, for which we incurred expenses of RMB12.9 million and
RMB29.2 million, respectively. For additional information, please see “Business — Our
Suppliers.”
OUR SHAREHOLDING STRUCTURE
Our Single Largest Group of Shareholders
Our Single Largest Group of Shareholders comprises Dr. Lu, Dr. Lan, GenFleet HK, and
our ESOP Platforms. As of the Latest Practicable Date, GenFleet HK was held as to 53.69%
by Dr. Lu and 46.31% by Dr. Lan. Pursuant to a concert party agreement dated March 25, 2022
entered into between Dr. Lu, Dr. Lan, GenFleet HK, Shanghai Kunjin, Shanghai Kunjue and
Auspicious Delight, they acknowledged and confirmed their relationship of acting in concert
in exercising the rights of the Shareholders and Directors of the Company. In the event the
parties are unable to reach consensus on matters of our Company, each of the parties shall act
in accordance with the instructions of Dr. Lu.
As of the Latest Practicable Date, our Single Largest Group of Shareholders controlled
approximately 25.23% of our total issued share capital. Immediately following the completion
of the Global Offering (assuming that the Offer Size Adjustment Option and the Over-allotment
Option are not exercised), our Single Largest Group of Shareholders will control approximately
19.56% of our total issued share capital.
Pre-IPO Investments
We completed several rounds of Pre-IPO Investments since our inception with an
aggregate amount of approximately RMB1,421 million raised. Our Pre-IPO Investors include
established funds and venture capitals, such as HighLight Capital, Huagai Capital and Asia
Investment Capital. For further details of the identity and background of the Pre-IPO Investors
and the principal terms of the Pre-IPO Investments, see “History, Development and Corporate
Structure — Pre-IPO Investments.” Our Sophisticated Investor which made meaningful
investment to us include Ourea Biotech, which will hold approximately 6.75% of our total
issued share capital upon the completion of the Global Offering (assuming that the Offer Size
Adjustment Option and the Over-allotment Option are not exercised).
SUMMARY
–2 0–


--- page 30 ---
SUMMARY OF KEY FINANCIAL INFORMATION
This summary of key financial information set forth below have been derived from, and
should be read in conjunction with, our historical financial information, including the
accompanying notes, set forth in the Accountants’ Report set out in Appendix I to this
Prospectus, as well as the information set forth in “Financial Information” of this Prospectus.
Our historical financial information was prepared in accordance with IFRSs.
Summary of Consolidated Statements of Profit or Loss
The following table sets forth our consolidated statements of profit or loss for the periods
indicated:
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
REVENUE /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,734 104,703 – 82,149
Cost of sales /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(684) (20,095) – (8,693)
Gross profit /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,050 84,608 – 73,456
Other income and gains /H1118/H1118/H1118/H1118/H111839,964 28,531 6,534 6,122
Research and development
costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(312,738) (332,124) (142,262) (69,818)
Administrative expenses /H1118/H1118/H1118/H1118(49,946) (58,081) (13,881) (23,684)
Other expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(176) (10) (2) (3)
Finance costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,485) (17,963) (13,615) (2,005)
Loss before change in fair
value of redemption
liabilities on equity shares /H1118 (251,331) (295,039) (163,226) (15,932)
Change in fair value of
redemption liabilities on
equity shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(256,993) (382,602) (241,461) (50,692)
LOSS BEFORE TAX /H1118/H1118/H1118/H1118/H1118/H1118(508,324) (677,641) (404,687) (66,624)
Income tax expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118––––
LOSS FOR THE
YEAR/PERIOD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(508,324) (677,641) (404,687) (66,624)
Attributable to:
Owners of the parent /H1118/H1118/H1118/H1118/H1118/H1118/H1118(508,324) (677,641) (404,687) (66,624)
SUMMARY
–2 1–


--- page 31 ---
We recorded net losses of RMB508.3 million and RMB677.6 million for the years ended
December 31, 2023 and 2024, respectively, and net losses of RMB404.7 million and RMB66.6
million for the four months ended April 30, 2024 and 2025, respectively. Our net losses
recorded and the fluctuations during the Track Record Period were primarily in relation to: (i)
our substantial investment in research and development activities, and (ii) the change in fair
value of redemption liabilities on equity shares due to the increase in value of our Company.
Developing quality drug candidates requires significant investments of financial
resources over a prolonged period of time, and a core part of our strategy is to continue making
sustained investments in this area. As a result of this commitment, we have invested a
significant amount of financial resources in research and development to advance and expand
our pipeline of clinical- and preclinical-stage drug candidates. The research and development
costs we incurred for the years ended December 31, 2023 and 2024 and the four months ended
April 30, 2024 and 2025 amounted to RMB312.7 million, RMB332.1 million, RMB142.3
million and RMB69.8 million, respectively.
Our research and development costs increased from RMB312.7 million for the year ended
December 31, 2023 to RMB332.1 million for the year ended December 31, 2024, primarily due
to an increase of RMB28.8 million in others, primarily attributable to an one-time payment of
RMB28.8 million under the patent licensing agreements, and was partially offset by a decrease
of RMB9.2 million in staff costs. Our research and development costs decreased from
RMB142.3 million for the four months ended April 30, 2024 to RMB69.8 million for the four
months ended April 30, 2025, primarily due to incurred expenses of RMB45.4 million on
termination of Ex-China option and RMB18.9 million under the patent licensing agreements,
each in the first four months of 2024. No such costs incurred in the first four months of 2025.
Our change in fair value of redemption liabilities on equity shares increased from
RMB257.0 million for the year ended December 31, 2023 to RMB382.6 million for the year
ended December 31, 2024, primarily due to the increase in value of our Company. Our change
in fair value of redemption liabilities on equity shares decreased from RMB241.5 million for
the four months ended April 30, 2024 to RMB50.7 million for the four months ended April 30,
2025, primarily due to the moderate growth in value of our Company.
SUMMARY
–2 2–


--- page 32 ---
During the Track Record Period, our revenue was derived from our collaboration with
Innovent regarding our Core Product GFH925, V erastem regarding our Core Product GFH375,
and SELLAS regarding GFH009. For additional information about the relevant agreements, see
“Business — Major Collaboration and Licensing Arrangements.” Most of the revenue that we
recognized during the Track Record Period was generated from licenses of intellectual property
under such collaboration and out-licensing arrangements. We also generated a small portion of
revenue from provision of research and development services, clinical and regulatory support
in connection with the collaboration with SELLAS, including medical monitoring, data
management, statistics and regulatory document preparation. The following table sets forth
components of our revenue.
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
Licenses of intellectual
property /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111871,779 90,035 – 80,742
Sales of goods /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 14,668 – 127
Research and development
services /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,955 – – 1,280
Total/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,734 104,703 – 82,149
For details, see “Financial Information — Description of Selected Components of
Consolidated Statements of Profit or Loss and Other Comprehensive Income.”
Summary of Consolidated Statements of Financial Position
The following table sets forth selected information from our consolidated statements of
financial position as of the dates indicated.
As of December 31, As of April 30,
2023 2024 2025
(RMB in thousands)
Total non-current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111885,390 38,573 35,465
Total current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118450,744 568,248 545,215
Total current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,832,107 2,493,429 2,525,029
Net Current Liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,381,363) (1,925,181) (1,979,814)
Total assets less current liabilities /H1118/H1118/H1118/H1118(1,295,973) (1,886,608) (1,944,349)
Total non-current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,338 69,653 69,290
Net liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,317,311) (1,956,261) (2,013,639)
SUMMARY
–2 3–


--- page 33 ---
During the Track Record Period, we had net liabilities position, which was primarily due
to the significant total comprehensive loss for the year/period in each year/period of the Track
Record Period caused by the significant redemption liabilities on equity shares and research
and development costs we incurred in each year/period of the Track Record Period. The
increase of net liabilities from RMB1,956.3 million as of December 31, 2024 to RMB2,013.6
million as of April 30, 2025 was primarily due to the loss for the period year of RMB66.6
million mainly driven by the research and development costs we incurred and an increase in
fair value of the Shares held by Pre-IPO Investors. The increase of net liabilities from
RMB1,317.3 million as of December 31, 2023 to RMB1,956.3 million as of December 31,
2024 was primarily due to the loss for the year of RMB677.6 million mainly driven by the
research and development costs we incurred and an increase in fair value of the Shares held by
Pre-IPO Investors. Upon the Listing, we expect to record equity shares issued in connection
with Pre-IPO Investments as equity and do not expect to recognize any redemption liabilities
on these equity shares, or recognize any future loss or gains in connection with such
redemption liabilities on our consolidated statements of profit or loss and other comprehensive
income. We therefore expect to have a net current asset and net asset position rather than a net
current liability and net liability position upon the Listing.
The increase of net current liabilities by RMB543.8 million from RMB1,381.4 million as
of December 31, 2023 to RMB1,925.2 million as of December 31, 2024 was primarily driven
by an increase of (i) redemption liabilities on equity shares by RMB577.6 million, (ii) trade and
other payables of RMB98.9 million from the payables under the termination of the ex-China
option and (iii) interest-bearing bank borrowings of RMB45.8 million, partially offset by an
increase of (i) time deposits and cash and cash equivalents of RMB62.7 million and (ii) trade
receivables of RMB36.8 million as well as a decrease in contract liabilities of RMB59.7
million, primarily attributable to the termination in January 2024 of the ex-China option
previously granted to Innovent for GFH925, as well as the recognition of contractual
obligations under the V erastem Agreement following the receipt of payments in 2024.
Our net current liabilities as of April 30, 2025 remained relatively stable and increased
by 2.8% to RMB1,979.8 million, primarily due to the increase of interest-bearing bank
borrowings of RMB34.0 million and redemption liabilities on equity shares by RMB50.7
million, partially offset by a decrease in trade and other payables of RMB22.3 million and
contract liabilities of RMB29.9 million.
SUMMARY
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Summary of Consolidated Statements of Cash Flows
The following table sets forth key items of our consolidated statements of cash flows for
the periods indicated:
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
Net cash used in operating
activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(202,060) (206,400) (136,945) (34,045)
Net cash flows from/(used
in) investing activities /H1118/H1118/H1118/H1118263,443 730 (122,716) 33,140
Net cash flows from/(used
in) financing activities /H1118/H1118/H1118/H1118(29,059) 233,438 204,905 28,182
Net increase in cash and cash
equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111832,324 27,768 (54,756) 27,277
Cash and cash equivalents at
beginning of year/period /H1118/H1118/H1118295,321 332,197 332,197 362,125
Effects of foreign exchange
rate changes, net /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,552 2,160 585 1,364
Cash and cash equivalents at
end of year/period /H1118/H1118/H1118/H1118/H1118/H1118/H1118332,197 362,125 278,026 390,766
During the Track Record Period, we incurred negative cash flows from our operations and
our operating cash outflows mainly resulted from our research and development costs. Our
operating activities used RMB202.1 million and RMB206.4 million for the years ended
December 31, 2023 and 2024 and RMB136.9 million and RMB34.0 million for the four months
ended April 30, 2024 and 2025, respectively. For details, see “Financial Information —
Liquidity and Capital Resources — Cash Flows.”
Key Financial Ratios
The table below sets forth the current ratio of our Group as of the dates indicated:
As of December 31, As of April 30,
2023 2024 2025
Current ratio (1) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180.25 0.23 0.22
Note:
(1) Current ratio equals current assets divided by current liabilities as of the end of the year/period.
SUMMARY
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WORKING CAPITAL CONFIRMATION
During the Track Record Period, we incurred negative cash flows from our operations and
our operating cash outflows mainly resulted from our research and development costs. Our
operating activities used RMB202.1 million and RMB206.4 million in 2023 and 2024 and
RMB136.9 million and RMB34.0 million for the four months ended April 30, 2024 and 2025,
respectively. We expect to generate more cash flow from our operating activities, through
income from launching and commercializing GFH925, forging productive collaboration
agreements with third parties, advancing the development and eventually commercializing
GFH925 overseas and other pipeline products, and enhancing our cost containment capacity
and operating efficiency.
Our Directors are of the opinion that, taking into account the financial resources
available, including cash and cash equivalents, the expected income from commercialization of
GFH925 in China, and the estimated net proceeds from the Listing, as well as our cash burn
rate, we have sufficient working capital to cover at least 125% of our costs, including research
and development expenses and administrative expenses for at least the next 12 months from the
date of this Prospectus.
Our cash burn rate refers to the average monthly amount of net cash used in operating
activities, capital expenditures and lease payments. Assuming an average cash burn rate going
forward of 1.1 times the level in 2024, we estimate that our cash at bank and on hand and other
financial assets as of September 30, 2025 will be able to maintain our financial viability for 71
months from September 30, 2025 taking into account the estimated net proceeds from the
Global Offering; or we estimate that we will be able to maintain our financial viability for 13
months from September 30, 2025 without taking into account the estimated net proceeds from
the Global Offering. We will continue to monitor our cash flows from operations closely and
expect to raise our next round of financing, if needed, with a minimum buffer of 12 months.
GLOBAL OFFERING STATISTICS
The Global Offering by us consists of:
 the offer by us of initially 7,760,000 Hong Kong Offer Shares, for subscription by
the public in Hong Kong, referred to in this prospectus as the Hong Kong Public
Offering; and
 the offer by us of initially 69,840,000 International Offer Shares, in the United
States to QIBs only in reliance on Rule 144A and outside the U.S. (including to
professional, institutional and other investors within Hong Kong) in offshore
transactions in reliance on Regulation S or another exemption from the registration
requirements under the U.S. Securities Act, referred to in this prospectus as the
International Offering.
Based on the
Offer Price of
HK$20.39
Market capitalization of our Shares (1) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
HK$7,041.5
million
Unaudited pro forma adjusted net tangible assets per Share (2) /H1118/H1118/H1118/H1118/H1118/H1118HK$5.06
SUMMARY
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Notes:
* All statistics in this table are on the assumption that (i) the Share Subdivision is completed; and (ii) the
Offer Size Adjustment Option and the Over-allotment Option are not exercised.
(1) The calculation of market capitalization is based on 345,340,630 Shares expected to be in issue
immediately after completion of the Share Subdivision and Global Offering, assuming the Offer Size
Adjustment Option and the Over-allotment Option are not exercised.
(2) The unaudited pro forma adjusted net tangible assets per Share is calculated after making the
adjustments referred to in “Financial Information — Unaudited Pro Forma Statement of Adjusted Net
Tangible Assets.”
DIVIDEND
We have never declared or paid any dividends on our ordinary shares or any other
securities. As of the Latest Practicable Date, we did not have a formal dividend policy. We
currently intend to retain all available funds and earnings, if any, to fund the development and
expansion of our business and we do not intend to declare or pay any dividends in the
foreseeable future. Investors should not purchase our ordinary shares with the expectation of
receiving cash dividends. Any future determination to pay dividends will be made at the
discretion of our Directors subject to our Articles of Association and the PRC Company Law,
and may be based on a number of factors, including our future operations and earnings, capital
requirements and surplus, general financial condition, contractual restrictions and other factors
that our Directors may deem relevant. No dividend shall be declared or payable except out of
our profits and reserves lawfully available for distribution. Regulations in the PRC currently
permit payment of dividends of a PRC company only out of accumulated distributable after-tax
profits as determined in accordance with its articles of association and the accounting standards
and regulations in China. As confirmed by our PRC Legal Advisor, according to the PRC law,
any future net profit that we make will have to be first applied to make up for our historically
accumulated losses, after which we will be obliged to allocate 10% of our net profit to our
statutory common reserve fund until such fund has reached more than 50% of our registered
capital. We will therefore only be able to declare dividends after (i) all our historically
accumulated losses have been made up for; and (ii) we have allocated sufficient net profit to
our statutory common reserve fund as described above.
USE OF PROCEEDS
We estimate that we will receive net proceeds of approximately HK$1,443.6 million after
deducting the underwriting fees and expenses payable by us in the Global Offering, assuming
no Offer Size Adjustment Option or Over-allotment Option is exercised and based on an Offer
Price of HK$20.39 per Offer Share. We intend to use the net proceeds we will receive from this
Offering for the following purposes:
 approximately HK$476.4 million (or approximately 33% of the net proceeds) to
fund the clinical development of our Core Product GFH925;
SUMMARY
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 approximately HK$548.6 million (or approximately 38% of the net proceeds) to
fund the clinical development of our Core Product GFH375;
 approximately HK$274.3 million (or approximately 19% of the net proceeds) to
fund the further development of our other candidates including GFH312, GFS202A,
GFH276, GFS784 and other preclinical product candidates in our pipeline; and
 approximately HK$144.4 million (or approximately 10% of the net proceeds) will be
used for our working capital and other general corporate purposes.
For further details, see “Future Plans and Use of Proceeds.”
RISK FACTORS
We are developing our Core Products and other product candidates in highly competitive
markets with intense competition from multi-national and domestic pharmaceutical companies
with multiple approved drugs and similar drug candidates at similar or more advanced clinical
stages. For more details, see “Risk Factors — We face competition from existing drugs and
drug candidates under development.”
Our licensing and collaboration agreements with partners may lead to uncertainties on the
development and commercialisation of certain product candidates, because these agreements
allowed our partners to control certain aspects of the development, commercialization, and
patenting process of the product candidates. Especially, our receipt of development or
commercialization milestone payments from our partners will depend upon their development
and commercialization efforts, which are beyond our control and may be uncertain.
We believe that there are certain other risks involved in our operations, many of which
are beyond our control. These risks are set out in the section headed “Risk Factors” in this
prospectus. Some of the major risks we face include:
 Our business and financial prospects depend substantially on the success of our
pipeline products. If we are not able to successfully complete clinical development,
obtain regulatory approval and commercialize our pipeline products, including our
Core Products, or experience delays in doing so, our business prospects could be
adversely affected.
 We may face intellectual property risks relating to third-party patents in China and
the U.S. that appear to cover GFH925. While we have secured licenses from relevant
Chinese patent holders to mitigate such risks, potential challenges from a broadly
scoped U.S. patent remain, though our IP counsel assesses its impact on our freedom
to operate in the U.S. as low. If we or our collaborators are unable to obtain and
maintain adequate patent and other intellectual property protection for our pipeline
products throughout the selected markets in the world, our ability to successfully
commercialize our pipeline products may be adversely affected.
SUMMARY
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 We rely on our current and future collaborators’ willingness and ability to devote
resources to the development and commercialization of our Core Products and other
pipeline products and to otherwise support our business as contemplated in our
collaboration agreements.
 We may not receive some or all of the potential milestone and/or royalty payments
from our collaboration and licensing agreements.
 We work with various third-party service providers to develop our pipeline products.
If these third parties fail to duly perform their contractual obligations or meet
expected timelines, we may be unable to obtain regulatory approvals for, or
commercialize, our pipeline products, and our business, financial condition and
results of operations could be materially and adversely affected.
 We face competition from existing drugs and drug candidates under development.
 Development of product candidates in combination with other therapies could
expose us to additional risks.
 The regulatory approval processes for pharmaceutical products are time consuming
and depend on numerous factors, and if we are ultimately unable to obtain regulatory
approval for our pipeline products, our business could be substantially harmed.
 We depend on third parties to provide a stable and adequate supply of investigational
drugs for our research and development efforts and supply of APIs for future
commercial sales. Any disruptions of or significant price increases in such supply
could adversely affect our business.
 The size of the actual markets for our pipeline products may be smaller than our
estimates and our pipeline products may not be able to achieve the degree of market
acceptance by physicians, patients, third-party payers and others in the medical
community that would be necessary for their commercial success.
 We may not be able to protect our intellectual property rights or prevent unfair
competition by third parties.
 We may become subject to intellectual property infringement claims, which could
expose us to substantial liability, harm our reputation, limit our research and
development or other business activities and/or impair our ability to commercialize
our product candidates.
 We are a biopharmaceutical company with a limited operating history, which may
make it difficult to evaluate our current business and predict our future performance.
 Any failure to comply with applicable laws and regulations and industry standards
or obtain various licenses and permits could harm our reputation, business, financial
condition, results of operations and prospects.
SUMMARY
–2 9–


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LISTING EXPENSES
Our listing expenses represent professional fees, underwriting commissions and other
fees incurred in connection with the Global Offering. Based on an Offer Price of HK$20.39 per
H Share, we estimated that the total listing expenses for the Global Offering are approximately
HK$138.8 million, accounting for approximately 8.8% of the gross proceeds from the Global
Offering (assuming no H Shares are issued pursuant to the Offer Size Adjustment Option or the
Over-allotment Option), of which approximately HK$19.3 million is expected to be charged to
our consolidated statements of profit or loss and other comprehensive income upon the
completion of Global Offering, and approximately HK$89.2 million is expected to be
accounted for as a deduction from equity upon the completion of Global Offering. The above
expenses comprise of (i) underwriting-related expenses, including underwriting commission
and other expenses, of HK$72.9 million; and (ii) non-underwriting-related expenses of
HK$65.8 million, including (a) fee paid and payable to legal advisors and reporting
accountants of HK$32.1 million, and (b) other fees and expenses of HK$33.8 million. RMBnil,
RMB18.4 million and RMB9.3 million of the listing expenses have been recognized in profit
or loss for the years ended December 31, 2023, 2024 and the four months ended April 30, 2025,
respectively. The listing expenses above are the latest practicable estimate for reference only,
and the actual amount may differ from this estimate.
RECENT DEVELOPMENTS
Clinical Development
In August 2024, the NMPA approved the NDA for GFH925 for the treatment of NSCLC,
making it the first KRAS G12C inhibitor approved in Mainland China and the third globally.
We also initiated the Phase I/II clinical trial of GFH375 in July 2024. Among the 33 patients
that have received administration of GFH375, antitumor activities have already been observed
at the starting dosage. We completed the Phase I part of GFH375’s clinical trial in January 2025
and initiated the Phase II part in February 2025. In addition, we submitted an IND application
for a Phase II clinical trial of GFH312 for the treatment of PBC to the NMPA in March 2025
and obtained NMPA’s approval in May 2025.
Further, we submitted to the NMPA an IND application to conduct a Phase I/II clinical of
GFH276 in June 2025 and obtained the IND approval in September 2025.
Expected Increased in Net Loss
We expect to record an increase in net loss for the year ending December 31, 2025 due
to (i) a decrease in the recognized revenue from licenses of intellectual property, (ii) an
increase in expenses in connection with the Listing incurred in 2025 and (iii) an increase in
R&D expenses in line with the R&D activities. However, we have incurred net losses since our
inception and anticipate that we will continue to incur net losses for the foreseeable future.
SUMMARY
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Progress in Chemistry, Manufacturing and Controls
We are advancing the development of the second-generation manufacturing process for
GFH925 and are fully responsible for all aspects of the process, including vendor selection. We
have completed internal research, evaluation, and validation of the new process, which utilizes
more cost efficient starting materials and achieves higher yields compared to the first-
generation process, resulting in improved cost control. We have directed our vendor to submit
a post-marketing manufacturing process change application to the provincial drug regulatory
authority in May 2025. This application is expected to be completed by the end of 2025, after
which we anticipate an improvement in the current loss-making status of our drug supply due
to the adoption of the second-generation manufacturing process.
We expect the second-generation process to substantially enhance the cost-efficiency of
production. We believe that our CMC capabilities not only ensure drug safety and quality but
also position us to independently pursue regulatory approvals outside of China and unlock
future commercial opportunities for GFH925 as key regulatory milestones are achieved.
During the Track Record Period, the costs incurred in fulfilling drug supply arrangements
for GFH925 exceeded the corresponding revenue from the sale of GFH925, mainly because
production was based on the first-generation CMC process, which had a higher cost profile
than the selling price to Innovent. We expect the cost of sales to be significantly reduced once
the second-generation CMC process is successfully implemented. However, before that occurs,
we expect to continue sell GFH925 at a gross loss in 2025 to Innovent. Such gross loss is
expected to increase for the remainder of 2025 should our sales of GFH925 to Innovent
increase.
It is of the Directors’ view that the continuous loss making transaction for sales of
GFH925 to Innovent will not have a material adverse impact to the Group’s financial and
operation, because it is necessary for us to develop second-generation CMC process for R&D
and eventually, commercialization purposes, in Ex-China Territory, and we anticipate an
improvement in the current loss-making status after the adoption of the second-generation
manufacturing process in 2026.
For detailed discussion of our CMC capabilities, see “Business — Chemistry,
Manufacturing and Controls (“ CMC”).” For discussion of our financial results related to the
CMC, see “Financial Information — Description of Selected Components of Consolidated
Statements of Profit or Loss and Other Comprehensive Income — Cost of Sales.”
SUMMARY
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Impact of COVID-19
During the Track Record Period and up to the Latest Practicable Date, we had not
experienced material disruptions in our operations as a result of COVID-19. During the
COVID-19 pandemic, we maintained operational continuity through remote work
arrangements across our offices.
Through effective coordination with our CRO and CDMO partners across various
locations, we sustained the smooth progress of our research activities and achieved key
regulatory milestones. As COVID-19’s global impact continued to lessen as of the Latest
Practicable Date, our Directors do not expect COVID-19 to have a material adverse impact on
our business going forward. See also “Risk Factors — Risks Relating to Our Operations — We
may be subject to disasters, health epidemics, acts of war, terrorism, business disruptions and
other force majeure events, which may have a material adverse effect on our business.”
NO MATERIAL ADVERSE CHANGE
Our Directors confirm that up to the date of this Prospectus, there has been no material
adverse change in our financial, operational or trading positions or prospects since April 30,
2025, being the end of the period reported on as set out in the Accountants’ Report included
in Appendix I to this Prospectus.
SUMMARY
–3 2–


--- page 42 ---
In this Prospectus, unless the context otherwise requires, the following terms shall
have the meanings set out below. Certain other terms are explained in the section headed
“Glossary of Technical Terms” in this Prospectus.
“2024 ASCO Cut-off Date” April 19, 2024, the cut-off date for the purpose of
reporting preliminary result of the KROCUS Study in
2024 ASCO Annual Meeting
“Accountants’ Report” the accountants’ report prepared by Ernst & Y oung,
details of which are set out in Appendix I
“affiliate(s)” with respect to any specified person, any other person,
directly or indirectly, controlling or controlled by or
under direct or indirect common control with such
specified person
“AFRC” the Accounting and Financial Reporting Council of Hong
Kong
“Articles of Association” or
“Articles”
the articles of association of our Company, as amended,
which shall become effective on the Listing Date, a
summary of which is set out in Appendix III
“associate(s)” has the meaning ascribed to it under the Listing Rules
“Audit Committee” the audit committee of the Board
“Auspicious Delight” Auspicious Delight Limited, a limited liability company
incorporated in the BVI on May 25, 2018, a member of
our Single Largest Group of Shareholders and an ESOP
Platform of our Group
“Board” or “our Board” the board of Directors
“Business Day” a day on which banks in Hong Kong are generally open
for normal business to the public and which is not a
Saturday, Sunday or public holiday in Hong Kong
“BVI” British Virgin Islands
“Capital Market Intermediaries”
or “capital market
intermediary(ies)” or “CMI(s)”
the capital market intermediaries participating in the
Global Offering and has the meaning ascribed thereto
under the Listing Rules
DEFINITIONS
–3 3–


--- page 43 ---
“CCASS” the Central Clearing and Settlement System established
and operated by HKSCC
“CDE” Center for Drug Evaluation (ᄲ൙ʕː)o fN M P A
“Chairman” chairman of the Board
“Chief Executive Officer” chief executive officer of our Company
“Chief Medical Officer” chief medical officer of our Company
“China,” “Mainland China” or
“PRC”
the People’s Republic of China which, for the purpose of
this Prospectus and for geographical reference only,
excluding Hong Kong Special Administrative Region of
the People’s Republic of China, Macau Special
Administrative Region of the People’s Republic of China,
and Taiwan Region
“close associate(s)” has the meaning ascribed thereto under the Listing Rules
“Companies (Winding Up and
Miscellaneous Provisions)
Ordinance”
the Companies (Winding Up and Miscellaneous
Provisions) Ordinance (Chapter 32 of the Laws of Hong
Kong) as amended, supplemented or otherwise modified
from time to time
“Companies Ordinance” the Companies Ordinance (Chapter 622 of the Laws of
Hong Kong) as amended, supplemented or otherwise
modified from time to time
“Company”, “our Company”,
“the Company”, or “GenFleet”
GenFleet Therapeutics (Shanghai) Inc. (Ҧ(ɪ
ऎ)ʮ̡), a company incorporated in the PRC as
a limited liability company on August 23, 2017 and
converted into a joint stock company with limited
liability on September 29, 2024
“Competent Authority” has the meaning ascribed thereto under Chapter 18A of
the Listing Rules
“Compliance Advisor” Guotai Junan Capital Limited
“connected person(s)” has the meaning ascribed thereto under the Listing Rules
“connected transaction(s)” has the meaning ascribed thereto under the Listing Rules
DEFINITIONS
–3 4–


--- page 44 ---
“Core Product(s)” has the meaning ascribed thereto under Chapter 18A of
the Listing Rules and are the products for the purpose of
satisfying the eligibility requirements under Chapter 18A
of the Listing Rule
“Corporate Governance Code” the Corporate Governance Code set out in Appendix C1
to the Listing Rules
“CSCO” Chinese Society of Clinical Oncology
“CSRC” the China Securities Regulatory Commission ( ʕ਷ᗇՎ
ึ)
“Director(s)” or “our Director(s)” the director(s) of our Company
“Dr. Lan” Dr. Jiong LAN, our co-founder, executive Director, Chief
Executive Officer and General Manager, and a member of
our Single Largest Group of Shareholders
“Dr. Lu” Dr. Qiang LU, our co-founder, Chairman, executive
Director, and a member of our Single Largest Group of
Shareholders
“EIT” the PRC enterprise income tax
“EIT Law” the Enterprise Income Tax Law of the PRC ( ʕശɛ͏
), as amended, supplemented or
otherwise modified from time to time
“EMA” the European Medicines Agency
“ESOP Platform(s)” Shanghai Kunjin, Shanghai Kunjue, Shanghai Kunqian
and Auspicious Delight
“EU” European Union
“EU IP Counsel” 2K Patentanwälte — München, our IP counsel as to the
laws of European Patent Convention (“ EPC”) and the
national patent laws of EPC contracting countries
DEFINITIONS
–3 5–


--- page 45 ---
“Exchange Participant” a person (a) who, in accordance with the Rules of the
Hong Kong Stock Exchange, may trade on or through the
Hong Kong Stock Exchange; and (b) whose name is
entered in a list, register or roll kept by the Hong Kong
Stock Exchange as a person who may trade on or through
the Hong Kong Stock Exchange
“Extreme Conditions” extreme conditions caused by a super typhoon as
announced by the government of Hong Kong
“FDA” U.S. Food and Drug Administration
“FINI” the “Fast Interface for New Issuance” a new digital
platform through which IPO market participants and
regulators can manage the end-to-end settlement process
for new listings in Hong Kong
“General Manager” general manager of our Company
“General Rules of HKSCC” the General Rules of HKSCC as may be amended or
modified from time to time and where the context so
permits, shall include the HKSCC Operational
Procedures
“GenFleet Australia” GENFLEET THERAPEUTICS (AUSTRALIA) PTY
LTD, a limited liability company incorporated in
Australia on July 15, 2020 and one of our Company’s
subsidiaries
“GenFleet Beijing” GenFleet Therapeutics (Beijing) Co., Ltd. (˙(̏ԯ)ᔼ
ʮ̡), a limited liability company established
under the laws of the PRC on February 22, 2022 and one
of our Company’s subsidiaries
“GenFleet Hangzhou” GenFleet Therapeutics (Hangzhou) Co., Ltd. (˙ᖹุ
(ψ)ʮ̡), a limited liability company established
under the laws of the PRC on September 26, 2023 and
one of our Company’s subsidiaries
“GenFleet HK” GenFleet Therapeutics (H.K.) Limited ( ਄೯ᖹุ(ಥ)
ʮ̡), a limited liability company incorporated in
Hong Kong on March 15, 2017 and a member of the
Single Largest Group of Shareholders
DEFINITIONS
–3 6–


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“GenFleet Shanghai” GenFleet Biopharmaceutical (Shanghai) Co., Ltd. (˙
ᔼᖹ(ɪऎ)ʮ̡), a limited liability company
established under the laws of the PRC on March 30, 2021
and one of our Company’s subsidiaries
“GenFleet U.S.” GenFleet Therapeutics Inc., a corporation incorporated in
Delaware, the United States on April 13, 2020 and one of
our Company’s subsidiaries
“GenFleet Zhejiang” Zhejiang GenFleet Therapeutics Co., Ltd. (˙ᖹุ
ʮ̡), a limited liability company established under
the laws of the PRC on April 8, 2018 and one of our
Company’s subsidiaries
“GenFleet Zhuhai” GenFleet Therapeutics (Zhuhai) Co., Ltd. (˙ᖹุ(म
ऎ)ʮ̡), a limited liability company established
under the laws of the PRC on November 1, 2023 and one
of our Company’s subsidiaries
“GFH925X1101” A Phase I/II clinical trial to evaluate safety, tolerability,
PK and efficacy in patients with advanced solid tumors
with KRAS G12C mutations in Mainland China
sponsored by Innovent and originally initiated by us
“Global Offering” the Hong Kong Public Offering and the International
Offering
“Group”, “our Group”, “our”,
“we” or “us”
our Company and our subsidiaries
“Guide for New Listing
Applicants”
the Guide for New Listing Applicants issued by the Hong
Kong Stock Exchange, as amended, supplemented or
otherwise modified from time to time
“H Share(s)” overseas listed foreign share(s) in the share capital of our
Company with a nominal value of RMB0.1 each, which
is/are to be subscribed for and traded in HK dollars and
to be listed on the Stock Exchange
“H Share Registrar” Computershare Hong Kong Investor Services Limited
“HighLight Capital” an investment firm operating Ourea Biotech, a
Sophisticated Investor, details of which are set out under
“History, Development and Corporate Structure —
Pre-IPO Investments — Information about our Pre-IPO
Investors — HighLight Capital”
DEFINITIONS
–3 7–


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“HK$” or “Hong Kong Dollars”
or “HK Dollars” and “HK
cents”
Hong Kong dollars, the lawful currency of Hong Kong
“HKSCC” Hong Kong Securities Clearing Company Limited, a
wholly-owned subsidiary of Hong Kong Exchanges and
Clearing Limited
“HKSCC EIPO ” the application for Hong Kong Offer Shares to be issued
in the name of HKSCC Nominees and deposited directly
into CCASS to be credited to your designated HKSCC
Participant’s stock account through causing HKSCC
Nominees to apply on your behalf, including by
instructing your broker or custodian who is a HKSCC
Participant to give electronic application instructions via
HKSCC’s FINI system to apply for Hong Kong Offer
Shares on your behalf
“HKSCC Nominees” HKSCC Nominees Limited, a wholly-owned subsidiary
of HKSCC
“HKSCC Participant” a participant admitted to participate in CCASS as a direct
clearing participant, a general clearing participant or a
custodian participant
“Hong Kong” or “HK” the Hong Kong Special Administrative Region of the
PRC
“Hong Kong Offer Shares” the 7,760,000 H Shares (taking into account the Share
Subdivision) offered by us for subscription at the Offer
Price pursuant to the Hong Kong Public Offering (subject
to adjustments as described in the section headed
“Structure of the Global Offering”)
“Hong Kong Public Offering” the offering of the Hong Kong Offer Shares for
subscription by the public in Hong Kong (subject to
adjustments as described in the section headed “Structure
of the Global Offering”) at the Offer Price (plus
brokerage, SFC transaction levy, Hong Kong Stock
Exchange trading fee and AFRC transaction levy), on and
subject to the terms and conditions described in the
section headed “Structure of the Global Offering”
DEFINITIONS
–3 8–


--- page 48 ---
“Hong Kong Stock Exchange” or
“Stock Exchange”
The Stock Exchange of Hong Kong Limited, a wholly
owned subsidiary of Hong Kong Exchange and Clearing
Limited
“Hong Kong Takeovers Code” or
“Takeovers Code”
the Codes on Takeovers and Mergers and Share Buy-
backs issued by the SFC, as amended, supplemented or
otherwise modified from time to time
“Hong Kong Underwriters” the underwriters listed in the paragraph headed
“Underwriting — Hong Kong Underwriters”, being the
underwriters of the Hong Kong Public Offering
“Hong Kong Underwriting
Agreement”
the underwriting agreement dated September 10, 2025,
relating to the Hong Kong Public Offering entered into
by, among other parties, our Company, the Overall
Coordinators and the Hong Kong Underwriters, as further
described in “Underwriting — Underwriting
arrangements and expenses — Hong Kong Public
Offering — Hong Kong Underwriting Agreement”
“Independent Third Party(ies)” any entity(ies) or person(s) who is not a connected person
of our Company within the meaning of the Hong Kong
Listing Rules
“Innovent” Innovent Biologics, Inc., a limited liability company
incorporated in the Cayman Islands in 2011 and listed on
the Hong Kong Stock Exchange (stock code: 1801)
and/or any of its subsidiaries, where the case may be
“International Offer Shares” the 69,840,000 H Shares (taking into account the Share
Subdivision) offered by our Company pursuant to the
International Offering (subject to adjustment as described
in the section headed “Structure of the Global Offering”)
together with any additional H Shares which may be
allotted and issued by our Company pursuant to the
exercise of the Offer Size Adjustment Option and the
Over-allotment Option
“International Offering” the offering of the International Offer Shares at the Offer
Price, in the United States to QIBs only in reliance on
Rule 144A and outside the United States in offshore
transactions in reliance on Regulation S under the U.S.
Securities Act or any other available exemption from the
registration requirement under the U.S. Securities Act, as
further described in the section headed “Structure of the
Global Offering”
DEFINITIONS
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--- page 49 ---
“International Underwriters” the group of international underwriters who are expected
to enter into the International Underwriting Agreement to
underwrite the International Offering
“International Underwriting
Agreement”
the underwriting agreement relating to the International
Offering expected to be entered into on or about
September 17, 2025 by our Company and the
International Underwriters, as further described in the
section headed “Underwriting — International Offering”
“Joint Bookrunners” the joint bookrunners as named in the section headed
“Directors, Supervisors and Parties Involved in the
Global Offering”
“KROCUS” or “GFH925X0201” A Phase Ib/II trial to evaluate the safety, tolerability, PK,
and efficacy of GFH925 in combination with cetuximab
in patients with previously untreated advanced NSCLC
harboring KRAS G12C mutation sponsored by us
“Joint Global Coordinators” the joint global coordinators as named in the section
headed “Directors, Supervisors and Parties Involved in
the Global Offering”
“Joint Lead Managers” the joint lead managers as named in the section headed
“Directors, Supervisors and Parties Involved in the
Global Offering”
“Latest Practicable Date” September 2, 2025, being the latest practicable date for
the purpose of ascertaining certain information contained
in this Prospectus prior to its publication
“Listing” the listing of our H Shares on the Main Board
“Listing Committee” the listing committee of the Hong Kong Stock Exchange
“Listing Date” the date, expected to be on or about Friday, September
19, 2025, on which the H Shares are to be listed and on
which dealings in the Shares are to be first permitted to
take place on the Hong Kong Stock Exchange
“Listing Rules” the Rules Governing the Listing of Securities on The
Stock Exchange of Hong Kong Limited, as amended,
supplemented or otherwise modified from time to time
DEFINITIONS
–4 0–


--- page 50 ---
“M&A Rules” the Regulations on Mergers and Acquisitions of Domestic
Enterprises by Foreign Investors (Իᒅ
)
“Main Board” the stock exchange (excluding the option market)
operated by the Hong Kong Stock Exchange which is
independent from and operated in parallel with the GEM
of the Hong Kong Stock Exchange
“MOFCOM” or “Ministry of
Commerce”
the Ministry of Commerce of the PRC ( ʕശɛ͏΍ձ਷
ਠਕ௅) (formerly known as the Ministry of Foreign
Trade and Economic Cooperation of the PRC ( ʕശɛ͏
௅))
“Ms. Zhang” Ms. ZHANG Wei ( ੵᙯ), an executive Director, the
secretary to the Board and a joint company secretary of
our Company
“NDRC” the National Development and Reform Commission ( ʕ
ึ)
“NHC” the National Health Commission (formerly known as the
National Health and Family Planning Commission) ( ʕശ
ึ)
“NMPA” the National Medical Products Administration of China
(္ຖ၍ଣ҅) or, where the context so requires,
its predecessor, the China Food and Drug Administration
(္ຖ၍ଣᐼ҅), or CFDA
“Nomination Committee” the nomination committee of the Board
“NPC” the National People’s Congress of the PRC ( ʕശɛ͏΍
ɽึ)
“Offer Price” the offer price per Offer Share (exclusive of brokerage
fee of 1%, SFC transaction levy of 0.0027%, Hong Kong
Stock Exchange trading fee of 0.00565% and AFRC
transaction levy of 0.00015%) of HK$20.39
“Offer Share(s)” the Hong Kong Offer Shares and the International Offer
Shares, with any additional H Shares which may be
allotted and issued pursuant to the exercise of the Offer
Size Adjustment Option and the Over-allotment Option
DEFINITIONS
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“Offer Size Adjustment Option” the option expected to be granted by our Company under
the International Underwriting Agreement to the
International Underwriters, exercisable by the Sole
Sponsor-Overall Coordinator (on behalf of other Overall
Coordinators and the International Underwriters),
pursuant to which our Company may allot and issue up to
an aggregate of 11,640,000 additional H Shares (taking
into account the Share Subdivision) (representing in
aggregate approximately 15% of the Offer Shares
initially being offered under the Global Offering
assuming the Over-allotment Option is not exercised) at
the Offer Price, to cover the excess demand in the
International Offering, if any, as described in the section
headed “Structure of the Global Offering — The
International Offering — Offer Size Adjustment Option”
“Over-allotment Option” the option expected to be granted by us to the
International Underwriters, exercisable by the Sole
Sponsor-Overall Coordinator (for itself and on behalf of
other Overall-Coordinators and the International
Underwriters) pursuant to the International Underwriting
Agreement, to require our Company to allot and issue up
to an aggregate of 11,640,000 additional H Shares (taking
into account the Share Subdivision) at the Offer Price
(representing 15% of the Offer Shares initially available
under the Global Offering, assuming the Offer Size
Adjustment Option is not exercised at all) or up to an
aggregate of 13,386,000 additional H Shares
(representing not more than 15% of the Offer Shares
initially available under the Global Offering assuming the
Offer Size Adjustment Option is exercised in full), in
each case, taking into account the Share Subdivision, to
cover over-allocations in the International Offering, if
any, exercisable at any time from the date of the
International Underwriting Agreement up to (and
including) the date which is the 30th day from the last
day for lodging of applications under the Hong Kong
Public Offering
“Overall Coordinators” the overall coordinators as named in the section headed
“Directors, Supervisors and Parties Involved in the
Global Offering”
DEFINITIONS
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“PBOC” the People’s Bank of China ( ʕ਷ɛ͏ვБ), the central
bank of the PRC
“PRC and U.S. IP Counsel” JunHe LLP and Jun He Law Offices P .C., our IP counsel
as to the PRC and U.S. intellectual property law
“PRC Company Law” Company Law of the People’s Republic of China ( ʕശɛ
ج)
PRC GAAP” generally accepted accounting principles in the PRC
“PRC Legal Advisor” Jia Y uan Law Offices, our legal advisor on PRC laws in
connection with the Global Offering
“Pre-IPO Equity Incentive
Scheme”
the pre-IPO equity incentive plan of our Company
approved and adopted in 2020 as amended and restated in
July 2023
“Pre-IPO Investment(s)” the investment(s) in our Group undertaken by the
Pre-IPO Investors prior to this initial public offering, the
details of which are set out in “History, Development and
Corporate Structure”
“Pre-IPO Investor(s)” the investor(s) making investments in our Group prior to
this initial public offering as set out in “History,
Development and Corporate Structure — Pre-IPO
Investments”
“Prospectus” this prospectus being issued in connection with the Hong
Kong Public Offering
“QIB” a qualified institutional buyer within the meaning of Rule
144A
“Regulation S” Regulation S under the U.S. Securities Act
“Remuneration Committee” the remuneration committee of the Board
“Renminbi” or “RMB” the lawful currency of the PRC
“Reporting Accountants” Ernst & Y oung, the reporting accountants of our
Company
“Rule 144A” Rule 144A under the U.S. Securities Act
DEFINITIONS
–4 3–


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“SAFE” the State Administration of Foreign Exchange of the PRC
(̮ි၍ଣ҅)
“SAMR” the State Administration for Market Regulation of the
PRC (̹ఙ္ຖ၍ଣᐼ҅), the
successor of the State Administration of Industry and
Commerce of the PRC (၍
ଣᐼ҅)
“SA T” the State Taxation Administration of the PRC ( ʕശɛ͏
೼ਕᐼ҅)
“SELLAS” SELLAS Life Sciences Group, Inc., a company
headquartered in New Y ork and listed on NASDAQ
(stock code: SLS)
“SFC” the Securities and Futures Commission of Hong Kong
“SFO” or “Securities and Futures
Ordinance”
the Securities and Futures Ordinance, Chapter 571 of the
Laws of Hong Kong, as amended, supplemented or
otherwise modified from time to time
“Shanghai Kunjin” Shanghai Kunjin Consulting Partnership (Limited
Partnership) (Άุ၍ଣፔ༔ΥྫΆุ (Υ
ྫ)), a limited partnership established in the PRC on
April 2, 2021, a member of our Single Largest Group of
Shareholders and an ESOP Platform of our Group of
which Dr. Lu is the sole general partner
“Shanghai Kunjue” Shanghai Kunjue Consulting Partnership (Limited
Partnership) ( ɪऎտᙂΆุ၍ଣፔ༔ΥྫΆุ (Υ
ྫ)), a limited partnership established in the PRC on
October 13, 2017, a member of our Single Largest Group
of Shareholders, a limited partner of Shanghai Kunjin,
and an ESOP Platform of our Group
“Shanghai Kunqian” Shanghai Kunqian Consulting Partnership (Limited
Partnership) (Άุ၍ଣፔ༔ΥྫΆุ (Υ
ྫ)), a limited partnership established in the PRC on
March 26, 2021, a member of our Single Largest Group
of Shareholders, a limited partner of Shanghai Kunjin,
and an ESOP Platform of our Group
“Shanghai Stock Exchange” the Shanghai Stock Exchange (ה׸)
DEFINITIONS
–4 4–


--- page 54 ---
“Share(s)” ordinary share(s) in the share capital of our Company
with a nominal value of RMB0.1 each upon the
completion of the Share Subdivision; before the
completion of the Share Subdivision, ordinary share(s) in
the share capital of our Company with a nominal value of
RMB1.0 each
“Share Subdivision” the sub-division of the Shares by the Company where the
Company subdivided its Share from one Share of
RMB1.0 each into ten Shares of RMB0.1 each, which
will become effective immediately prior to the Listing
“Shareholder(s)” holder(s) of our Share(s)
“Shenzhen Stock Exchange” the Shenzhen Stock Exchange (ה׸)
Single Largest Group of
Shareholders”
refers to Dr. Lu, Dr. Lan, GenFleet HK, and our ESOP
Platforms
“Sole Sponsor” the sole sponsor of the Listing as named in “Directors,
Supervisors and Parties Involved in the Global Offering”
“Sole Sponsor-Overall
Coordinator”
the Sole Sponsor-Overall Coordinator as named in the
section headed “Directors, Supervisors and Parties
involved in the Global Offering”
“Sophisticated Investor(s)” has the meaning ascribed to it under Chapter 2.3 of the
Guide for New Listing Applicants
“Stabilizing Manager” CLSA Limited
“State Council” the State Council of the PRC ( ʕശɛ͏΍ձ਷਷ਕ৫)
“subsidiary(ies)” has the meaning ascribed to it in section 15 of the
Companies Ordinance
“substantial shareholder(s)” has the meaning ascribed to it under the Listing Rules
“Supervisor(s)” supervisor(s) of the Company
“Supervisory Committee” the committee of the Supervisors
DEFINITIONS
–4 5–


--- page 55 ---
“Track Record Period” the period comprising the financial years ended
December 31, 2023 and 2024 and the four months ended
April 30, 2025
“U.S. Government” the federal government of the United States, including its
executive, legislative and judicial branches
“U.S. persons” U.S. persons as defined in Regulation S
“U.S. Securities Act” United States Securities Act of 1933, as amended,
supplemented or otherwise modified from time to time
“Underwriters” the Hong Kong Underwriters and the International
Underwriters
“Underwriting Agreements” the Hong Kong Underwriting Agreement and the
International Underwriting Agreement
“United States”, “USA” or
“U.S.”
the United States of America, its territories, its
possessions and all areas subject to its jurisdiction
“Unlisted Share(s)” ordinary share(s) issued by our Company, with a nominal
value of RMB0.1 each (taking into account the Share
Subdivision), which is/are not listed on any stock
exchange
“US$” or “U.S. dollars” United States dollars, the lawful currency of the United
States
“V A T” value-added tax
“V erastem” V erastem, Inc., a company headquartered in
Massachusetts and listed on NASDAQ (stock code:
VSTM)
“White Form eIPO ” the application for Hong Kong Offer Shares to be issued
in the applicant’s own name, submitted online through
the designated website of the White Form eIPO Service
Provider, at www.eipo.com.hk
“White Form eIPO Service
Provider”
Computershare Hong Kong Investor Services Limited
“%” per cent
DEFINITIONS
–4 6–


--- page 56 ---
Certain amounts and percentage figures included in the Prospectus have been subject to
rounding adjustments. Accordingly, figures shown as totals in certain tables may not be an
arithmetic aggregation of the figures preceding them.
For ease of reference, the names of Chinese laws and regulations, governmental
authorities, institutions, natural persons or other entities (including our subsidiary) have been
included in this Prospectus in both the Chinese and English languages and in the event of any
inconsistency, the Chinese versions shall prevail. English translations of company names and
other terms from the Chinese language are provided for identification purposes only.
DEFINITIONS
–4 7–


--- page 57 ---
This glossary contains explanations of certain technical terms used in this
Prospectus in connection with our Group and its business. Such terminology and
meanings may not correspond to standard industry meanings or usages of those terms.
“AEs” adverse events, any untoward medical occurrences in a
patient or clinical investigation subject administered a
drug or other pharmaceutical product during clinical
trials and which do not necessarily have a causal
relationship with the treatment
“AESIs” adverse events of special interest, AEs of scientific and
medical concern specific to the sponsor’s product
“AKT” a serine/threonine protein kinase with three isoforms
(AKT1, AKT2 and AKT3) that participate in multiple
pathways regulating several cellular processes, including
survival, proliferation, tissue invasion, and metabolism
“AML” acute myeloid leukemia, a cancer that affects bone
marrow and blood
“antibody” also known as an immunoglobulin, a protein used by the
immune system to recognize and bind an antigen
“API” active pharmaceutical ingredient
“apoptosis” a form of programmed cell death in which a programmed
sequence of events leads to the elimination of cells
“A TP” adenosine triphosphate, an organic compound and
hydrotrope that provides energy to drive many processes
in living cells
“BID” twice-daily administration
“BIW” twice-weekly administration
“BOR” best overall response that the participant or patient has
had at any visit during the study
“BTD” Breakthrough Therapy Designation, a process designed to
expedite the development and review of drugs that are
intended to treat a serious condition
GLOSSARY OF TECHNICAL TERMS
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“CAGR” compound annual growth rate
“CDK” cyclin-dependent kinases, a family of protein kinases
regulating the cell cycle, also involved in regulating
transcription, mRNA processing, and the differentiation
of nerve cells
“CDMO” contract development and manufacturing organization, a
pharmaceutical company that develops and manufactures
drugs for other pharmaceutical companies on a
contractual basis
“CDX” cell line-derived xenograft
“DLT” dose-limiting toxicity, side effects of a drug that are
serious enough to prevent an increase in dose
“chemotherapy” a category of cancer treatment that uses one or more
anti-cancer chemotherapeutic agents as part of its
standardized regimen
“clinical trial/study” a research study carried out in human for validating or
finding the therapeutic effects and side effects of test
drugs in order to determine the therapeutic value and
safety of such drugs
“CLL/SLL” chronic lymphocytic leukaemia/small lymphocytic
lymphoma, a type of cancer in which the bone marrow
makes too many lymphocytes
“CMC” chemistry, manufacturing and controls
“CMO” contract manufacturing organization, a company that
serves other companies in the pharmaceutical industry on
a contract basis to provide comprehensive services from
drug development through drug manufacturing
“cohort” a group of patients as part of a clinical study who share
a common characteristic or experience within a defined
period and who are monitored over time
“combination therapy” treatment in which a patient is given two or more drugs
(or other therapeutic agents) for a single disease
GLOSSARY OF TECHNICAL TERMS
–4 9–


--- page 59 ---
“CR” complete response, the disappearance of all signs of
cancer in response to treatment
“CRC” colorectal cancer, the development of cancer from the
colon or rectum
“CRO” contract research organization, a company that provides
support to the pharmaceutical, biotechnology, and
medical device industries in the form of research services
outsourced on a contract basis
“CRR” complete response rate, the proportion of patients who
achieve a complete response to a treatment
“CSF” cerebrospinal fluid, a clear, colorless, watery fluid that
flows in and around your brain and spinal cord
“CTIS” Clinical Trials Information System, a system maintained
by EMA to support interactions throughout the lifecycle
of a clinical trial
“CypA” cyclophilin A, a ubiquitously distributed protein
belonging to the immunophilin family
“DCR” disease control rate, the proportion of patients who have
achieved either a complete response, partial response, or
stable disease after treatment
“DLBCL” diffuse large B-cell lymphoma, a type of non-Hodgkin
lymphoma characterized by the rapid growth of large B
cells in lymphoid tissue
“DoR” duration of response, the length of time that a tumor
continues to respond to treatment without the cancer
growing or spreading
“ERK” extracellular signal-regulated kinase, a key protein in the
mitogen-activated protein kinase signaling pathway
“EGFR” epidermal growth factor receptor, a cell surface protein
that plays a key role in cellular signaling and growth
“FADD” Fas-associated death domain protein, a key adapter
protein that plays a crucial role in apoptosis
GLOSSARY OF TECHNICAL TERMS
–5 0–


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“FAScon” functional antibody synergetic conjugate, a type of
bioconjugate consisting of an antibody attached with
another functionally synergistic molecule through a
linker, such as a drug or a toxin, to enhance its efficacy
in targeting cellular signaling pathways
“FGFR” fibroblast growth factor receptor, a family of receptor
tyrosine kinases that play a critical role in cell growth,
differentiation, and tissue repair
“fibrosis” a condition marked by increase of interstitial fibrous
tissue
“right of first to file” a contractual right granting one party the first opportunity
to file patent or other intellectual property applications
related to jointly developed or collaborative inventions.
Exercising such right allows the right holder to lead the
filing process, including decisions on timing,
jurisdiction, and scope. It does not preclude the other
party from retaining ownership or usage rights, which are
typically defined separately in the collaboration
agreement. If the right holder declines or chooses not to
file, the other party may be permitted to lead the filing
process, subject to agreed terms
“FLIP” FADD-like IL-1 /H9252-converting enzyme — inhibitory
protein, a protein that plays a crucial role in regulating
apoptosis and inflammation; it mainly has two isoforms,
FLIP(S), the short isoform, and FLIP(L), the long
isoform
“FTD” Fast Track Designation
“GCP” good clinical practice, an international ethical and
scientific quality standard for the performance of a
clinical trial on medicinal products involving humans
“GMP” good manufacturing practice, the practices required in
order to conform to the guidelines recommended by
agencies that control the authorization and licensing of
the manufacture and sale of products
GLOSSARY OF TECHNICAL TERMS
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--- page 61 ---
“Grade,” which is in
relation to AE
term used to refer to the severity of adverse events
according to Common Terminology Criteria for Adverse
Events (CTCAE), using Grade 1, Grade 2, Grade 3, etc.
“GDP” guanosine diphosphate, a nucleotide that plays a
significant role in cellular metabolism and signaling; it is
composed of a guanine base, a ribose sugar, and two
phosphate groups
“GTP” guanosine triphosphate, a nucleotide that serves as an
essential energy source and signaling molecule in various
biological processes; it is composed of a guanine base, a
ribose sugar, and three phosphate groups
“GTPase” guanosine triphosphatase, an enzyme that catalyzes the
hydrolysis of GTP to GDP and inorganic phosphate
“HRAS” Harvey RAS, a member of the RAS family proteins
“IARC” International Agency for Research on Cancer
“IC” intermittent claudication, a disease characterized by pain,
cramping, or heaviness in the legs or buttocks
“IC
50” half-inhibitory concentration
“immunodeficiency” a state in which the immune system’s ability to fight
infectious diseases and other invaders is compromised or
absent
“immunotherapy” use of the immune system to treat disease
“IMPD” investigational medicinal product dossier, a document
that provides information about a drug intended for use in
clinical trials
“indication” a specific condition, disease, or medical purpose for
which a drug, treatment, or medical device is intended or
approved for use
“in vitro ” studies that are performed with microorganisms, cells, or
biological molecules outside their normal biological
context
GLOSSARY OF TECHNICAL TERMS
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--- page 62 ---
“in vivo ” studies in which the effects of various biological entities
are tested on whole, living organisms or cells, usually
animals, including humans, and plants, as opposed to a
tissue extract or dead organism
“IND” investigational new drug, the application for which is the
first step in the drug review process by regulatory
authorities to decide whether to permit clinical trials
“irAEs” immune-related adverse events, adverse events that occur
as a result of immunotherapies
“KRAS” Kirsten RAS, a member of the RAS family proteins
“lines of treatment” different methods to treating cancer at different stages,
such first-line, second-line, third-line etc.
“LUSC” lung squamous cell carcinoma, a type of NSCLC
characterized by the uncontrolled growth of squamous
cells in the lung lining
“MAD” multiple ascending dose, a type of clinical study designed
to evaluate a drug after administering multiple doses over
a specific period
“MAPK” mitogen-activated protein kinase, a family of proteins
involved in transmitting signals from cell surface
receptors to the nucleus
“MCL1” myeloid cell leukemia 1, a member of the B-cell
lymphoma 2 family of proteins, which are crucial
regulators of apoptosis
“MEK” MAPK/ERK, a key protein kinase that plays a crucial role
in the MAPK signaling pathway
“metastatic” in reference to any disease, including cancer, disease-
producing organisms or of malignant or cancerous cells
transferred to other parts of the body by way of the blood
or lymphatic vessels or membranous surfaces
“mechanism of action” the specific biochemical interaction through which a drug
substance produces its pharmacological effect
GLOSSARY OF TECHNICAL TERMS
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“MLKL” mixed lineage kinase domain like pseudokinase, a protein
that plays a crucial role in the process of necroptosis, a
form of programmed cell death distinct from apoptosis
“monotherapy” therapy that uses a single drug to treat a disease or
condition
“MSC” member state concerned, a country that is involved in a
regulatory process within the context of the European
Union
“MTD” maximum tolerated dose, the highest dose of a drug or
treatment that does not cause unacceptable side effects
“multi-regional clinical trial” a clinical trial that is conducted in different regions under
a common trial design for simultaneous global new drug
development
“NCC” National Cancer Center
“NCCN” National Comprehensive Cancer Network
“NDA” new drug application, a process required by an regulatory
authority to approve a new drug for sale and marketing
“NF-/H9260B” nuclear factor kappa B, a key transcription factor that
plays a crucial role in regulating immune response,
inflammation, cell proliferation, and survival
“NRAS” neuroblastoma RAS, a member of the RAS family
proteins
“NSCLC” non-small-cell lung carcinoma, any carcinoma (as an
adenocarcinoma or squamous cell carcinoma) of the
lungs that is not a small-cell lung carcinoma
“ODD” Orphan Drug Designation
“ORR” overall response rate, the proportion of patients who have
a partial or complete response to therapy
“OS” overall survival, a length of time that a patient with a
specific disease is still alive, used as a measurement of a
drug’s effectiveness
GLOSSARY OF TECHNICAL TERMS
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--- page 64 ---
“P-TEFb” positive transcription elongation factor b, a crucial
protein complex involved in the regulation of
transcription elongation during gene expression
“PAD” peripheral artery disease, a circulatory condition
characterized by narrowed arteries
“PBC” primary biliary cholangitis, an autoimmune liver disease
resulting from a slow, progressive destruction of the
intra-hepatic small bile ducts
“PCT” Patent Cooperation Treaty, an international patent law
treaty that provides a unified procedure for filing patent
applications in its contracting states
“PD” pharmacodynamics, the branch of pharmacology
concerned with the effects of drugs and the mechanism of
their action
“PD-1” programmed death protein 1, an immune checkpoint
receptor expressed on T cells, B cells and macrophages,
acting to turn off the T cell mediated immune response as
part of the process that stops a healthy immune system
from attacking other pathogenic cells in the body
“PD-L1” programmed death-ligand 1, a protein on the surface of a
normal cell or a cancer cell that attaches to PD-1 on the
surface of the T cell that causes the T cell to turn off its
ability to kill the cancer cell
“PDAC” pancreatic ductal adenocarcinoma, a type of exocrine
pancreatic cancer that develops from cells lining small
tubes in the pancreas called ducts and accounts for over
90% of all pancreatic cancer cases
“PFS” progression-free survival, the length of time during and
after the treatment of a disease, such as cancer, that a
patient lives without the disease getting worse. In a
clinical trial, measuring the progression-free survival is
one way to see how well a new treatment works
GLOSSARY OF TECHNICAL TERMS
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--- page 65 ---
“Phase I clinical trial(s)” study in which a drug is introduced into healthy human
subjects or patients with the target disease or condition
and tested for safety, dosage tolerance, absorption,
metabolism, distribution, excretion, and if possible, to
gain an early indication of its effectiveness. Phase I
clinical trials can be divided into Phase Ia and Phase Ib
clinical trials. Phase Ia typically involves dose-escalation
studies, while Phase Ib generally focuses on combination
therapy or dose-expansion studies
“Phase II clinical trial(s)” study in which a drug is administered to a limited patient
population to identify possible adverse effects and safety
risks, to preliminarily evaluate the efficacy of the product
for specific targeted diseases, and to determine dosage
tolerance and optimal dosage
“Phase III clinical trial(s)” study in which a drug is administered to an expanded
patient population generally at geographically dispersed
clinical trial sites, in well-controlled clinical trials to
generate enough data to statistically evaluate the efficacy
and safety of the product for approval, to provide
adequate information for the labeling of the product
“PI3K” phosphoinositide 3 kinase, an important signaling
pathway for many cellular functions such as growth
control, metabolism and translation initiation
“PK” pharmacokinetics, the study of the bodily absorption,
distribution, metabolism, and excretion of drugs, which,
together with pharmacodynamics, influences dosing,
benefit, and adverse effects of the drug
“PMDA” Pharmaceuticals and Medical Devices Agency of Japan
“PO” per os, the Latin for “by mouth”
“PR” partial response, a decrease in the size of a tumor or the
extent of cancer in the body following treatment, but not
a complete disappearance of the disease
“PI” principal investigator, a key individual responsible for
the overall design, conduct, and management of clinical
trials
GLOSSARY OF TECHNICAL TERMS
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“placebo” a medical treatment or preparation with no specific
pharmacological activity
“preclinical studies” studies testing a drug on non-human subjects, to gather
efficacy, toxicity, pharmacokinetic and safety
information and to decide whether the drug is ready for
clinical trials
“primary endpoint” the main or most important outcome at the end of a study
to assess the effect of the drug being investigated
“PTCL” peripheral T-cell lymphoma, a group of hematologic
malignancies that arise from mature T-cells and natural
killer cells
“QD” once-daily administration
“QT interval” a measurement made on an electrocardiogram used to
assess some of the electrical properties of the heart
“QW” once weekly administration
“R&D” research and development
“RA” rheumatoid arthritis, an inflammatory autoimmune
disorder that primarily affects the joints
“RAF” rapidly accelerated fibrosarcoma, a group of kinases that
play a crucial role in the MAPK/ERK signaling pathway
“RALGDS” Ral guanine nucleotide dissociation stimulator, a protein
that functions as a guanine nucleotide exchange factor for
RalA and RalB
“RAS” rat sarcoma, a family of proteins that are critical
regulators of cellular signaling pathways; it primarily
includes HRAS, KRAS, and NRAS
“RDE” recommended dose for expansion, the dosage of a drug
that is suggested for use in clinical trials, particularly
during the phase of expanding a treatment
“refractory” disease or condition that does not respond to treatment
GLOSSARY OF TECHNICAL TERMS
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“relapsed” a patient initially responds to drug treatment, but the
disease subsequently returns after a period of
improvement or remission
“RIPK” receptor-interacting serine/threonine-protein kinase, a
family of serine/threonine kinases that play a significant
role in apoptosis, necroptosis and inflammation
“RLBP1” retinaldehyde-binding protein 1, a protein that plays a
crucial role in the visual cycle
“RMS” reporting member state
“RP2D” recommended Phase II dose, the dosage of a drug that is
suggested for use in Phase II clinical trials
“RTK” receptor tyrosine kinase, a subclass of cell surface
receptors that play a crucial role in cellular
communication and signaling
“SAD” single ascending dose, a clinical trial design used
primarily to assess a drug by administering a single dose
that gradually increases
“SAE” serious adverse event
“SD” stable disease, a situation where a patient’s cancer does
not significantly worsen or improve after treatment
“SM” substantial modification of the materials submitted
through the CTIS
“SMO” site management organization, an organization that
provides clinical trial related services to a company or a
clinical site
“t
1/2” half-life, the time required for the concentration to fall to
50% of its peak value
“TEAE” treatment emergent adverse event, adverse events not
present prior to medical treatment, or an already present
event that worsens either in intensity or frequency
following the treatment
GLOSSARY OF TECHNICAL TERMS
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“TGA” Therapeutic Goods Administration of Australia
“TGF-/H9252” transforming growth factor- /H9252, a multifunctional cytokine
that signals through the binding with its receptors and
plays a critical role in various cellular processes
“TGF-/H9252R” transforming growth factor- /H9252receptor
“T
max” time of maximum concentration, the time point after
administration of a drug at which the highest
concentration of the drug is observed in the bloodstream
or target tissue
“TNF-/H9251” tumor necrosis factor- /H9251, a cytokine that plays a central
role in inflammation and immune responses
“TNFR1” tumor necrosis factor receptor 1
“TRAE” treatment-related adverse event, undesirable events not
present prior to medical treatment or an already present
event that worsens in intensity or frequency as a result of
the treatment
“TTR” time to response, the duration from the initiation of
treatment to the first observable response in a patient
“UDCA” ursodeoxycholic acid, a bile acid that is used primarily in
the treatment of certain liver and gallbladder diseases
GLOSSARY OF TECHNICAL TERMS
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We have included in this Prospectus forward-looking statements. Statements that are not
historical facts, including but not limited to statements about our intentions, beliefs,
expectations or predictions for the future, are forward-looking statements.
This Prospectus contains forward-looking statements and information relating to us and
our subsidiaries that are based on the beliefs of our management as well as assumptions made
by and information currently available to our management. When used in this Prospectus, the
words “aim,” “anticipate,” “aspire,” “believe,” “could,” “expect,” “going forward,” “intend,”
“may,” “ought to,” “plan,” “project,” “schedule,” “seek,” “should,” “target,” “vision,” “will,”
“would,” and the negative of these words and other similar expressions, as they relate to us or
our management, are intended to identify forward-looking statements. Such statements reflect
the current views of our management with respect to future events, operations, liquidity and
capital resources, some of which may not materialize or may change. These statements are
subject to certain risks, uncertainties and assumptions, including the risk factors as described
in “Risk Factors” and elsewhere in this Prospectus, some of which are beyond our control and
may cause our actual results, performance or achievements, or industry results, to be materially
different from any future results, performance or achievements expressed or implied by the
forward-looking statements. Y ou are strongly cautioned that reliance on any forward-looking
statements involves known and unknown risks and uncertainties. The risks and uncertainties
facing us which could affect the accuracy of forward-looking statements include, but are not
limited to, the following:
 our operations and business prospects;
 future developments, trends and conditions in the industries and markets in which
we operate or plan to operate;
 general economic, political and business conditions in the markets in which we
operate, including but not limited to interest rates, foreign exchange rates;
 changes to the regulatory environment in the industries and markets in which we
operate;
 our ability to maintain relationship with, and the actions and developments
affecting, our major business partners, suppliers and future customers;
 our ability to maintain the market leading positions and the actions and
developments of our competitors;
 our ability to effectively control costs and operating expenses;
 the ability of business partners to perform in accordance with contractual terms and
specifications;
 our ability to retain senior management and key personnel and recruit qualified staff;
FORW ARD-LOOKING STATEMENTS
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 our business strategies and plans to achieve these strategies, including our drug
development plans, commercialization strategies and geographic expansion plans;
and
 all other risks and uncertainties described in “Risk Factors.”
By their nature, certain disclosures relating to these and other risks are only estimates and
should one or more of these uncertainties or risks, among others, materialize, actual results
may vary materially from those estimated, anticipated or projected, as well as from historical
results. Specifically but without limitation, sales could decrease, costs could increase, capital
costs could increase, capital investment could be delayed and anticipated improvements in
performance might not be fully realized.
Subject to the requirements of applicable laws, rules and regulations, we do not have any
and undertake no obligation to update or otherwise revise the forward-looking statements in
this Prospectus, whether as a result of new information, future events or otherwise. As a result
of these and other risks, uncertainties and assumptions, the forward-looking events and
circumstances discussed in this Prospectus might not occur in the way we expect or at all.
Accordingly, you should not place undue reliance on any forward-looking information. All
forward-looking statements in this Prospectus are qualified by reference to the cautionary
statements in this section as well as the risks and uncertainties discussed in the section headed
“Risk Factors” in this Prospectus.
In this Prospectus, statements of or references to our intentions or those of our Directors
are made as of the date of this Prospectus. Any such information may change in light of future
developments.
FORW ARD-LOOKING STATEMENTS
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An investment in our H Shares involves various risks. You should carefully consider
all the information in this Prospectus and in particular the risks and uncertainties
described below before making an investment in our H Shares. In particular , we are a
biopharmaceutical company seeking to list on the Main Board of the Stock Exchange
under Chapter 18A of the Listing Rules. Our operations and the biopharmaceutical
industry involve certain risks and uncertainties, some of which are beyond our control
and may cause you to lose all your investment in our H Shares. The occurrence of any
of the following events could materially and adversely affect our business, financial
condition, results of operations or prospects. If any of these events occurs, the trading
price of our H Shares could decline, and you may lose all or part of your investment.
Additional risks and uncertainties not presently known to us, or not expressed or implied
below, or that we deem immaterial, could also harm our business, financial condition and
results of operations.
These factors are contingencies that may or may not occur , and we are not in a
position to express a view on the likelihood of any such contingency occurring. The
information given is as of the Latest Practicable Date unless otherwise stated, will not
be updated after the date hereof, and is subject to the cautionary statements in the section
headed “Forward-looking Statements” in this Prospectus. You should seek professional
advice from your relevant advisors regarding your prospective investment in the context
of your particular circumstances.
We believe there are certain risks and uncertainties involved in our operations, some of
which are beyond our control. We have categorized these risks and uncertainties into: (i) risks
relating to the development, clinical trials and regulatory approval of our pipeline products, (ii)
risks relating to dependence on third parties, (iii) risks relating to commercialization and
manufacturing of our pipeline products; (iv) risks relating to our intellectual property rights;
(v) risks relating to our financial position, (vi) risks relating to our operations, (vii) risks
relating to doing business in jurisdictions where we operate and (viii) risks relating to the
Global Offering.
Additional risks and uncertainties that are presently not known to us or not expressed or
implied below or that we currently deem immaterial could also have a material adverse effect
on our business, financial condition, results of operations and prospects. Y ou should consider
our business and prospects in light of the challenges we face, including the ones discussed in
this section.
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RISKS RELATING TO THE DEVELOPMENT, CLINICAL TRIALS AND
REGULATORY APPROV AL OF OUR PIPELINE PRODUCTS
Our business and financial prospects depend substantially on the success of our pipeline
products. If we are not able to successfully complete clinical development, obtain
regulatory approval and commercialize our pipeline products, including our Core
Products, or experience delays in doing so, our business prospects could be adversely
affected.
While one of our Core Products, GFH925, has received NDA approval from the NMPA,
as of the Latest Practicable Date, our other drug candidates and GFH925 in jurisdictions
outside China had not been approved for commercialization. We believe our future revenue and
profitability will substantially depend on our ability to complete the development of our drug
candidates, obtain requisite regulatory approvals and successfully manufacture and
commercialize our drug candidates. We have invested a significant portion of our efforts and
capital resources in the development of our existing drug candidates, and we expect to incur
substantial and increasing expenditures for the development and commercialization of our drug
candidates in the future. However, development of new drugs, including developing our Core
Products GFH375 in Greater China and GFH925 in overseas markets, can be time-consuming
and costly, and the outcome may be uncertain. The success of our drug candidates will depend
on several factors, including:
 successful enrollment in, and completion of, clinical trials, as well as completion of
preclinical studies;
 favorable safety and efficacy data from our clinical trials and other studies;
 receipt of regulatory approvals;
 establishing sufficient manufacturing capabilities to ensure supply for clinical use
and future commercialization, either by building facilities ourselves or making
arrangements with third-party manufacturers;
 our ability to effectively and simultaneously design, manage and supervise a number
and range of clinical trials in multiple jurisdictions;
 our ability to reach agreements on acceptable terms with prospective third-party
service providers, such as CROs, and trial sites, the terms of which can be subject
to negotiation and may vary among different third-party service providers and trial
sites;
 the performance by contract research organizations, or CROs, or other third parties
we may retain of their duties to us in a manner that complies with our protocols and
applicable laws and that protects the integrity of the resulting data;
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 obtaining and maintaining patent, trade secret and other intellectual property
protection and regulatory exclusivity;
 ensuring we do not infringe, misappropriate or otherwise violate the patent, trade
secret or other intellectual property rights of third parties;
 successfully launching our drug candidates, if and when approved;
 obtaining favorable reimbursement from third-party payors for drugs, if and when
approved;
 competition with other products and drug candidates;
 continued acceptable safety profile following regulatory approval; and
 obtaining sufficient supplies of any drug products that may be necessary for use in
clinical trials for evaluation of our drug candidates in combination with such drug
products.
If we do not achieve one or more of these factors in a timely manner or at all, we could
experience significant delays in our ability or be unable to obtain approval for and/or to
successfully commercialize our drug candidates, which would materially harm our business
and we may not be able to generate sufficient revenues and cash flows to continue our
operations.
We are focused on development and commercialization of new drugs for the treatment of
oncology and inflammatory-related diseases, and we have explored multiple modalities in the
exploration process. A substantial part of our pipeline programs are therapies targeting RAS
family members, against which it had been so challenging to develop selective inhibitors that
RAS proteins earned the reputation of being “undruggable” for decades. RAS-targeting
therapies under development by us not only include small molecules but also modalities
involving conjugates of small molecule and antibody. Given their novelty and differentiated
features, our pipeline products may carry inherent development risks that could result in delays
and cost overruns in clinical development, regulatory approvals or commercialization. The
successful development of certain pipeline products, such as our Core Product GFH925 in
China, does not guarantee similarly successful development of other pipeline products. For
related risks, see “— Clinical development involves a lengthy and expensive process with
uncertain outcomes, and results of earlier studies and trials may not be predictive of future trial
results.”
Furthermore, due to the novelty of our therapeutics, a substantial amount of education and
training may need to be provided to patients and medical personnel in the future, which may
potentially increase our sales and marketing expenses. These risks and uncertainties may have
a material adverse effect on future profits generated from our drug candidates, which in turn
may materially and adversely affect our competitive position, business, financial condition and
results of operations.
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If we or our collaborators are unable to obtain and maintain adequate patent and other
intellectual property protection for our pipeline products throughout the selected markets
in the world, our ability to successfully commercialize our pipeline products may be
adversely affected.
Our commercial success depends, to a material extent, on our or our collaborators’ ability
to protect our proprietary technologies and pipeline products from competition by obtaining,
maintaining, defending and enforcing our intellectual property rights, including patent rights.
We seek to protect the pipeline products and technologies that we consider commercially
important primarily by filing patent applications in China, the United States, the EU and other
countries or regions, relying on trade secrets or pharmaceutical regulatory protection or
employing a combination of these methods. This process is expensive and time-consuming, and
we or our business partners may not be able to file all necessary or desirable patent applications
and secure other intellectual property protection in all desirable jurisdictions in a timely
manner.
As of the Latest Practicable Date, we held 72 issued patents and 118 patent applications
(including 9 PCT applications), of which 12 issued patents and 61 patent applications
(including 2 PCT applications) are related to our Core Products. We cannot assure you that all
of our patent applications will be granted. Patent applications may not be granted for a number
of reasons, including a later application date, known or unknown prior art, deficiencies in the
patent application or the lack of novelty or non-obviousness of the underlying invention or
technology. China, the U.S. and Europe have adopted the “first-to-file” system, under which
the first inventor to file a patent application will be awarded the patent if all other patentability
requirements are met. Moreover, patent applications in China, the U.S., Europe and other
jurisdictions are typically not published until a 18-month waiting period after filing, or in some
cases, not at all. In addition, under the PRC Patent Law, any organization or individual that
applies for a patent in a foreign country for an invention or utility model accomplished in China
is required to file in advance to CNIPA for confidentiality examination. Otherwise, if an
application is later filed in China, the patent right will not be granted. Therefore, we cannot be
certain that we or our collaborators were the first to make the inventions claimed in our owned
or licensed patents or pending patent applications or that we or our collaborators were the first
to file for patent protection of such inventions.
As a result of the first-to-file system, waiting period before publication or other
applicable laws and regulations, in the case that a third party and us/our collaborators
independently invent proprietary molecules, compounds or other technologies with certain
overlapping patentable aspects, but the third party files a relevant patent application prior to
us and publish after 18 months or even no publication at all, such third-party patent application,
even not issued yet, may become a conflicting application of which we/our collaborators would
not be aware until its publication. If the third party can establish that we or our collaborators
were not the first to file for patent protection of our proprietary or licensed inventions even
only certain immaterial aspects thereunder, such inventions, though independently developed
by us or our collaborators, may not issue as patents and even if issued, may be challenged and
invalidated or ruled unenforceable or have to be amended to delimit the previous protection
RISK FACTORS
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scope, and third parties may be granted a patent relating to a compound, molecule or
technology which we independently invented, and our pipeline candidates covered by such
inventions may be subject to third-party infringement claims. In such cases, we may be
required to obtain and maintain licenses from third parties. For instance, we independently
invented compounds related to our Core Product, GFH925, and obtained issued patents for
these compounds in the PRC and the U.S. We also filed patent applications related to GFH925
in other jurisdictions. However, through the freedom-to-operate analysis we conducted, which
did not cover Taiwan, Hong Kong or Macau, we are aware of certain general formula
compounds claimed in third-party patents issued in Mainland China that may cover the
chemical structure of GFH925. Since then, we entered into agreements with holders of such
third-party patents, to proactively manage any potential risks from these patents. In addition,
given our freedom-to-operate analysis did not include Taiwan, Hong Kong and Macau, we
cannot rule out potential patent infringement risks in these jurisdictions.
On November 20, 2023, we entered into a license agreement with such a third party,
which granted us a non-exclusive and sublicensable license to practice a Chinese patent owned
by the third party in the research, improvement, manufacture, use, offer to sell, sell, and import
of medical products containing or using GFH925 within Mainland China. The patent was
issued in 2022, and is expected to expire in 2040. The patent is directed to a chemical formula
that appears to cover the chemical structure of GFH925. Under the licensing agreement, we
will pay the third party a total of RMB4.5 million in three milestone payments, and we retain
a right of first offer in the event that the third party intends to transfer-out or sub-license its
rights related to the patent. All the three payments shall be made within 30 business days of
our receipt of the third party’s invoice for the respective amount. We have made the three
payments to the third party timely and in full, as of the Latest Practicable Date. As provided
in the licensing agreement, if we have made any one of the three payments timely and in full,
the third party agrees not to assert infringement allegations or cause interference against our,
our sub-licensees’, our interested parties’ or our related parties’ research, improvement,
manufacture, use, offer to sell, sell, develop, commercialize, export and import of a medical
product containing GFH925 within Mainland China, including by instituting a lawsuit,
arbitration or other government proceedings.
On February 28, 2024, we entered into a license agreement with a third-party group which
granted us a non-exclusive and sublicensable license to practice four patents owned by the third
parties in Greater China, as well as their current and future related patents or patent
applications the same patent family in Greater China, in the research, manufacture, use, offer
to sell, sell, improvement, export and import of medical products containing GFH925 within
Greater China. The four licensed patents are directed to a chemical formula that appears to
cover the chemical structure of GFH925 and are expected to expire in 2040. We are required
to make a total of RMB30.0 million to the third parties in two milestone payments and
mid-teens royalties tied to the achievement of specific regulatory and commercialization
milestones and the receipt of royalty payments. As of the Latest Practicable Date, we have paid
such RMB30.0 million to the third parties pursuant to the license agreement. Provided that we
and our related parties, our sub-licensees and sub-contractors abide by the license agreement,
RISK FACTORS
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the third parties agree not to assert infringement allegations or otherwise cause interference
against our, our sub-licensees’, sub-contractors’ or our related parties’ commercialization of
GFH925, including by instituting a lawsuit, arbitration or other government proceedings.
We also are aware that a third party’s patent in the U.S. includes claims defining the
compounds solely by functional characteristics, without specifying their chemical structure. To
further assess the potential risk, we have conducted a comprehensive freedom-to-operate
analysis with respect to our core products, including GFH925, in the U.S. and sought advice
from our legal advisor as to the U.S. intellectual property laws. Based on this analysis, and
considering the legal standards in the U.S. regarding claim validity, including enablement and
written description requirements, we believe that these broadly defined claims, which are
solely based on functional characteristics, may raise concerns about their validity and
enforceability in U.S. courts due to insufficient enablement and written description support.
Accordingly, we do not believe that a license agreement similar to the ones we entered
in China is currently necessary for GFH925 in the U.S., and therefore, we have not entered into
license agreements with respect to this U.S. patent. We continue to monitor the IP landscape
closely and will consider appropriate measures, including licensing or legal action, if new risks
arise.
As for our products candidates GFH312 and GFH375, we have not identified patents and
patent applications in China or the U.S. that may pose an infringement risk. However, even
with reasonable due diligence, our patent search may not be exhaustive. In other words, we
cannot guarantee that we are able to identify all the patents and patent applications that may
lead to patent disputes regarding our product candidates.
The coverage claimed in a patent application can be significantly reduced before the
patent is issued, and its scope can be reinterpreted after issuance. Even if patent applications
we own currently or in the future are issued as patents, they may not be issued in a form that
will provide us with any meaningful protection, prevent competitors or other third parties from
competing with us, or otherwise provide us with any competitive advantage. In addition, the
patent positions of biotech and pharmaceutical companies often involve complex legal and
factual questions and have been the subject of increasing litigations in recent years.
Consequently, we cannot be sure that we will acquire or maintain patent protections with the
desired scope over our pipeline products or technologies. Our competitors or other third parties
may be able to circumvent our patents by developing similar or alternative technologies or
products in a non-infringing manner.
It is also possible that we or our business partners will fail to identify patentable aspects
of our research and development output before it is too late to obtain patent protection.
Moreover, we or our business partners may fail to timely identify third-party infringement of
our intellectual property rights and take necessary actions to defend and enforce our rights, or
at all. If any of the foregoing scenarios materialize, our ability to successfully commercialize
our pipeline products may be adversely affected.
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We rely on our current and future collaborators’ willingness and ability to devote
resources to the development and commercialization of our Core Products and other
pipeline products and to otherwise support our business as contemplated in our
collaboration agreements, and we may not have adequate control over patents and patent
applications covering the drug candidates that involve our current and future
collaborators.
We rely on our current and future collaborators to support our business, including to assist
with, or to conduct, clinical development and regulatory filings, manufacturing and/or
commercialization of certain of our pipeline products. For example, we have granted Innovent
exclusive rights to develop, manufacture and commercialize one of our Core Products,
GFH925, in Greater China. GFH925 obtained the NDA approval from the NMPA in August
2024. Pursuant to the agreement, Innovent shall be solely responsible for commercializing
GFH925 in Greater China, and we are entitled to certain royalties and commercial milestone
payments that are keyed to the annual net sales of GFH925 in Greater China, in addition to
other enumerated upfront and milestone payments. For additional information, see “Business
— Major Collaboration and Licensing Agreements.” Therefore, our future financial position
will partly depend on the commercialization efforts of Innovent.
However, as we may have little or no control over the marketing and sales efforts beyond
the contractual terms, the actual revenue generated from the commercialization of GFH925
may be lower than the anticipated revenue, and we may not realize the contemplated benefits
from this collaboration. There is also no assurance that our collaborators will not seek to
change the terms of the collaboration agreement with the effect of diminishing benefits to us.
If we do not realize the contemplated benefits from our current and expected collaborations,
our business, financial condition and results of operations may be materially harmed.
We may not have the right to control the preparation, filing, prosecution, maintenance,
enforcement or defense of patents and patent applications covering the drug candidates that
involve our current and future collaborators. For example, the Innovent Agreement granted to
Innovent the first right (but not the obligation) to file and maintain the patents that cover
inventions jointed developed by both parties. For more information, please see “Business —
Major Collaboration and Licensing Arrangements — Innovent Agreement.” Therefore, we
cannot be certain that these patents and patent applications will be prepared, filed, maintained,
enforced and defended in a manner consistent with the best interests of our business. If we
continue to enter into collaboration agreements in the future, and such future collaborators fail
to file, maintain, enforce or defend the patents we license in, or lose rights to those patents or
patent applications, the rights we will have licensed may be reduced or eliminated, and our
right to develop and commercialize any of our drugs that are subject of such potential licensed
rights could be adversely affected.
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We cannot assure you that our existing or future collaborations will not be terminated
prior to the expiry of contemplated terms. Such terminations could significantly impact the
development and commercialization of our pipeline products and impact our financial results
and future prospects. Any failure by any current or future collaborators to perform their
obligations under our agreements for any reason, including its obligations to make milestone
payments or pay royalties, or modification of termination of such agreements, could have a
material adverse effect on our financial performance.
Our collaboration and licensing agreements with certain third parties, including V erastem
and Innovent, establish a joint steering committee (“ JSC”) with decision-making authority
relating to the performance of the collaboration and licensing agreements. The JSC makes
decisions by voting. If a deadlock in voting occurs, the JSC would be unable to render a
decision. Though our collaboration and licensing agreements provide alternative decision-
making mechanisms upon such deadlock, such as negotiation by the parties’ senior executives,
the deadlock may cause delay, disruption or loss of good faith in the parties’ collaboration.
Moreover, the alternative decision-making mechanisms may still be unable to resolve the
parties’ differences the performance of the collaboration and licensing agreement. In that case,
the third party may have the final decision-making authority in the jurisdiction where the third
party has acquired rights to the subject product candidate, such as under the collaboration and
licensing agreements with V erastem and Innovent, such that the final decision may favor the
third party but not us.
Our collaboration agreement with Merck did not establish a JSC. If the parties are unable
to resolve a dispute, the Merck Agreement provided that the unresolvable dispute shall be
finally settled at the competent courts of Geneva, Switzerland. We did not have an unresolvable
dispute with Merck during the Track Record Period. However, such unresolvable dispute, if it
occurs, may cause delay, disruption or loss of good faith in the parties’ collaboration.
We may continue to receive from certain of our current and future collaborators with
information about the status, progress and results of clinical trials and regulatory processes that
they are conducting, sponsoring or pursuing with respect to our partnered product candidates.
We may not have direct access to the underlying data or direct communications with the
relevant regulators. In addition, our collaboration with our current and future collaborators
could subject us to a number of additional risks, including the following:
 our collaborators have significant discretion regarding whether and on what timeline
to pursue planned activities;
 we cannot control the quantity and nature of the resources our collaborators may
devote to the development, commercialization, marketing and distribution of
products or product candidates;
 disputes between us and our collaborators may delay or terminate the research,
development or commercialization of the applicable pipeline products or result in
costly litigation or arbitration that diverts management’s attention and resources;
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 we may not receive stipulated milestone payments from our collaborators, at the
expected time or at all, if our collaborators do not achieve future milestones or if we
and our collaborators disagree about whether a milestone has been reached;
 with respect to collaborations, partnerships or other arrangements under which we
have an active role, we and our collaborators may have differing opinions or
priorities, or we may encounter challenges in joint decision making, which may
delay or terminate the research, development or commercialization of the applicable
products and product candidates;
 our collaborators may not properly maintain or defend relevant intellectual property
rights, or may infringe the intellectual property rights of third parties, or may use our
or third parties’ proprietary information in such a way as to invite litigation that
could jeopardize or invalidate our proprietary information or expose us to potential
litigation; and
 business combinations, financial difficulties or significant changes in a
collaborator’s business strategy may adversely affect that collaborator’s willingness
or ability to continue to pursue our products or product candidates.
Any one or more of the foregoing risks, if realized, could have a material adverse effect
on our business, financial condition and results of operations.
We may not receive some or all of the potential milestone and/or royalty payments from
our collaboration and licensing agreements.
From time to time, we enter into collaboration and licensing agreements that include
clauses regarding potential development and commercial milestone payments and/or royalties.
The milestone payments will only be payable to us upon the achievement of certain milestones
based on clinical development progress and achievement of specified amounts of annual net
sales of the licensed products. We may also receive tiered royalties tied to the net sales amount
of the licensed products. For example, pursuant to the Innovent Agreement, Innovent shall be
solely responsible for commercializing GFH925 in Greater China, and we are entitled to
certain royalties and commercial milestone payments that are keyed to the annual net sales of
GFH925 in Greater China, in addition to other enumerated upfront and milestone payments.
There is a risk that any or all of the milestone events under these various agreements might not
be achieved, that our licensees may not achieve sales that would entitle us to royalty payments,
and that any or all of the consideration tied to the achievement of the milestone events and/or
royalties might not be received.
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We work with various third-party service providers to develop our pipeline products. If
these third parties fail to duly perform their contractual obligations or meet expected
timelines, we may be unable to obtain regulatory approvals for, or commercialize, our
pipeline products, and our business, financial condition and results of operations could be
materially and adversely affected.
We have worked with and may continue to work with third-party service providers on our
ongoing preclinical and clinical programs. For example, we seek assistance from CROs,
clinical trial sites, consultants and other third parties to monitor, support and/or conduct
preclinical studies and clinical trials of our drug candidates. We work with these parties to
execute our preclinical studies and clinical trials, and control only certain aspects of their
activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted
in accordance with the applicable protocols, legal and regulatory requirements and scientific
standards, and our collaboration with the CROs does not relieve us of our regulatory
responsibilities. We, our CROs for our clinical programs and our clinical investigators are
required to comply with GCPs, which are regulations and guidelines enforced by the NMPA,
the FDA, the EMA and other comparable regulatory authorities for all of our drug candidates
in clinical development. If we or any of our CROs or clinical investigators fail to comply with
the applicable GCP , the clinical data generated in our clinical trials may be deemed unreliable
and the NMPA, the FDA, the EMA or other comparable regulatory authorities may require us
to perform additional clinical trials before approving our marketing applications. In addition,
our pivotal clinical trials must be conducted with products produced under GMP regulations.
Any failure to comply with these regulations may require us to repeat clinical trials, which
would delay the regulatory approval process. Furthermore, due to the involvement of
thirdparties such as CROs, the data we gather in our research and development may be affected
by factors unrelated to our drug candidates or out of our control, which could adversely affect
the reliability of results derived from our research and development activities.
If any of our relationships with these third-party CROs terminates, we may not be able
to enter into arrangements with alternative CROs or to do so on commercially reasonable
terms. In addition, our CROs are not our employees, and except for remedies available to us
under our agreements with such CROs, we cannot control whether or not they devote sufficient
time and resources to our ongoing clinical and nonclinical programs. If CROs fail to duly
perform their contractual obligations or meet expected timelines, if they need to be replaced
or if the quality or accuracy of the clinical data they or our clinical investigators obtain is
compromised due to failure to adhere to our clinical protocols, regulatory requirements or for
other reasons, our clinical trials may be extended, delayed or terminated and we may not be
able to obtain regulatory approvals for, or successfully commercialize, our drug candidates.
Switching or adding additional CROs involves additional cost and delays, which can materially
influence our ability to meet our desired clinical development timelines. Any of the foregoing
events may cause increases in costs, restrict our ability to generate revenue and have a material
adverse effect on our business, financial condition, results of operations and prospects.
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Our ability to generate future revenue is partly dependent on our ability to work
effectively with collaborators to develop our drug candidates, including to obtain regulatory
approvals. Our arrangements with collaborators will be critical to the successful
commercialization of our drug candidates and future products. We rely on collaborators in
various respects, including to undertake research and development programs and conduct
clinical trials, manage or assist with the regulatory filings and approval process, and to assist
with our commercialization efforts. We do not control our collaborators, and therefore there
can be no assurance that these third parties will adequately and timely perform all of their
obligations under their agreements with us. If they fail to complete the remaining studies
successfully, or at all, it could delay or adversely affect the obtaining of regulatory approvals.
There can be no assurance of the satisfactory performance of any of our collaborators, and if
any of our collaborators breach or terminate their agreements with us, we may not be able to
successfully commercialize the product which could materially and adversely affect our
business, financial condition, cash flows and results of operations.
We face competition from existing drugs and drug candidates under development.
We face competition from existing drugs and drug candidates under development in the
global innovative drug market. Competition in therapeutic areas such as oncology and
immunology diseases, to which our Core Products and many other pipeline assets belong, is
intense given the abundance of existing competing oncology therapy options, approved drugs
and drug candidates that continue to increase. For instance, with respect to our Core Product
GFH925, an inhibitor of KRAS protein that harbors the G12C mutation (“ KRAS G12C ”),
adagrasib and sotorasib, both of which have been approved for marketing in the United States
and the EU and garsorasib recently approved in China, address the same target, and there are
a number of competing drug candidates currently under different development stages. Beyond
drugs addressing RAS proteins, there have also been a number of approved drugs, such as a
variety of tyrosine kinase inhibitors, for the treatment of NSCLC globally. For additional
information on the market landscape, see “Industry Overview.”
In addition, the wide application of traditional cancer therapies, such as surgeries,
radiotherapies and chemotherapies, also poses significant competition for our drug candidates.
Our drug candidates and lines of treatments may not be selected unless and until one or more
of these more conventional and widely adopted cancer treatments have been adopted, which
could potentially negatively affect the size of our total addressable market for our drug
candidates.
Our commercial opportunities may be adversely impacted if our competitors develop and
commercialize drugs that are safer, more effective, more convenient, or less expensive than any
of the drugs that we may develop or commercialize. Our competitors also may obtain approval
from the NMPA, the FDA, the EMA or other comparable regulatory authorities for their drugs
more quickly than we do, which could result in our competitors establishing a strong market
position before we are able to enter the market. This may render our pipeline products obsolete
or less competitive before we can recover the expenses of developing and commercializing our
pipeline products. Additionally, even if approved and commercialized, our drug candidates
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may fail to achieve the degree of market acceptance by physicians, patients, third-party payers
and others in the medical community necessary for commercial success. See “— The size of
the actual markets for our pipeline products may be smaller than our estimates and our pipeline
products may not be able to achieve the degree of market acceptance by physicians, patients,
third-party payers and others in the medical community that would be necessary for their
commercial success.”
Many of the companies against which we are competing or against which we may
compete in the future have significantly greater financial, technical and human resources and
expertise in research and development, manufacturing, pre-clinical testing, conducting clinical
trials, obtaining regulatory approvals and marketing approved drugs than we do. Smaller and
other early-stage companies may also prove to be significant competitors, particularly through
collaborative arrangements with large and established companies. Additional mergers and
acquisitions in the pharmaceutical industries may result in even more resources being
concentrated among a smaller number of competitors. These third parties compete with us in
recruiting and retaining qualified scientific and management personnel, establishing clinical
trial sites and patient registration for clinical trials, as well as in acquiring technologies
complementary to, or necessary for, our programs.
Clinical development involves a lengthy and expensive process with uncertain outcomes,
and results of earlier studies and trials may not be predictive of future trial results.
Clinical development is capital-intensive and may demand years of effort to complete,
while its outcomes are inherently uncertain and may not be favorable. We may encounter
unexpected difficulties while executing our clinical development plans for our drug candidates.
Failure can occur at any time or stage during the clinical development process, which would
result in a material and adverse effect on our business, financial condition and results of
operations.
Furthermore, the results of preclinical studies and early clinical trials may not be
predictive of the success of later-phase clinical trials, and favorable initial or interim results of
a clinical trial do not necessarily indicate the success of final results. Drug candidates in later
stages of clinical trials may fail to show the desired safety and efficacy profiles despite having
progressed through preclinical studies and initial clinical trials. Many companies in the
biopharmaceutical industry have experienced significant setbacks in advanced clinical trials
due to unsatisfactory efficacy or adverse safety profiles, notwithstanding promising results in
earlier trials. It is also common that various aspects of the development programs, such as
manufacturing and formulation, are altered along the entire research and development stage in
an effort to optimize processes and results, and there can be no assurance that such alterations
would help achieve the intended objectives.
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There may be significant variability in safety or efficacy results among different trials of
the same drug candidate due to numerous factors, including changes in trial procedures set
forth in protocols, differences in size and demographics of the enrolled patients (such as
genetic differences and patient adherence to the dosage regimen) and the dropout rate among
enrolled patients in clinical trials. Differences in the number of clinical trial sites and countries
involved may also lead to variability among clinical trials. Therefore, the results of planned
clinical trials or other future clinical trials could be significantly different and deviate from our
expectation, which could result in delays in the completion of clinical trials, regulatory
approvals and commencement of commercialization of our drug candidates.
If clinical trials of our drug candidates fail to demonstrate safety and efficacy profiles to
the satisfaction of regulatory authorities or do not otherwise produce positive results, we
may incur additional costs or experience delays in completing, or ultimately be unable to
complete, the development and commercialization of our drug candidates.
Before obtaining regulatory approval for the sale of our drug candidates, we must conduct
extensive clinical trials to demonstrate the safety and efficacy profiles of our drug candidates
in humans. We may experience certain unexpected events during, or as a result of, clinical trials
that could delay or prevent our ability to receive regulatory approval or commercialize our drug
candidates, including but not limited to: regulators, institutional review boards, or IRBs, or
ethics committees may not authorize us or our investigators to commence a clinical trial or
conduct a clinical trial at a prospective trial site; manufacturing issues, including problems
with manufacturing, supply quality, compliance with drug Good Manufacturing Practice, or
GMP , or obtaining from third parties sufficient quantities of a drug candidate for use in a
clinical trial; clinical trials of our drug candidates may produce negative or inconclusive
results, and we may decide, or regulators may require us, to conduct additional clinical trials
or abandon drug development programs; our third-party contractors, including clinical
investigators, may fail to comply with regulatory requirements or meet their contractual
obligations to us in a timely manner, or at all; we might have to suspend or terminate clinical
trials of our drug candidates for various reasons, including a finding of a lack of clinical
response or other unexpected characteristics or a finding that participants are being exposed to
unacceptable health risks.
Adverse events (“ AEs”) and undesirable side effects caused by our drug candidates could
cause us or regulatory authorities to interrupt, delay or halt clinical trials and may result in a
narrowed scope of indications or a more restrictive label of our drug candidates, a delay or
denial of regulatory approval by the NMPA, the FDA, the EMA or other comparable regulatory
authorities, or a significant change in our clinical protocol or even our development plan.
Results of trials conducted by us or by our collaborators with respect to our drug candidates
could reveal a high and unacceptable severity or prevalence of certain AEs. In such an event,
such trials could be suspended or terminated and the NMPA, the FDA, the EMA or other
comparable regulatory authorities could order us or our licensing partners, as applicable, to
cease further development of, or deny approval of, our drug candidates for any or all targeted
indications. AEs related to our drug candidates may also affect subject recruitment or the
ability of enrolled subjects to complete the trial and could result in potential liability claims.
Any of these occurrences may significantly harm our reputation, business, financial condition
and prospects.
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If we are required to conduct additional clinical trials or other testing of our drug
candidates beyond those that we currently contemplate, if we are unable to successfully
complete clinical trials of our drug candidates or other testing, if the results of these trials or
tests are not positive or are only modestly positive or if they raise safety concerns, we may:
 be delayed in obtaining regulatory approval for our drug candidates;
 not obtain regulatory approval at all;
 obtain approval for indications that are not as broad as intended;
 have the drug removed from the market after obtaining regulatory approval;
 be subject to additional post-marketing testing requirements;
 be subject to restrictions on how the drug is distributed or used;
 be unable to obtain reimbursement for use of the drug; or
 be held liable for harm caused to our patients and be subject to litigation and product
liability claims.
Significant clinical trial delays may also increase our development costs and could
shorten any periods during which we have the exclusive right to commercialize our drug
candidates or allow our competitors to bring drugs to market before we do. This could impair
our ability to commercialize our drug candidates and may harm our business and results of
operations.
Development of product candidates in combination with other therapies could expose us
to additional risks.
In addition to monotherapies, we are developing certain pipeline products with other
commercialized therapies as combination therapies to achieve potential synergistic effects and
improved efficacy profile. For instance, we are investigating the safety and efficacy of one of
our Core Products, GFH925, in combination with cetuximab developed and commercialized by
Merck for the treatment of NSCLC harboring the KRAS G12C mutation in Europe. For
additional information, see “Business — Core Product GFH925: A Small Molecule Inhibitor of
KRAS G12C — Licenses, Rights and Obligations — Merck Agreement.” However,
development of any of our product candidates in combination with one or more other therapies
could expose us to additional risks. For instance, we may be unable to successfully develop or
market our pipeline products or may experience significant regulatory delays, if safety, efficacy
or other issues arise from any pharmaceutical product or medical treatment used, or intended
to be used, in combination with our drug candidates. Additionally, as combination therapies
may increase the rate of serious or unexpected AEs, which could result in a clinical hold as well
as pre-approval and post-approval restrictions by the regulatory authorities on the proposed
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combination therapy, including narrowing of the indication, warnings, additional safety data
collection and monitoring procedures, even if the cause of such serious or unexpected AEs is
not directly attributed to our product candidate. Any of these events or restrictions could have
a material adverse effect on our business, delay our regulatory approval, and decrease the
market acceptance and profitability of our product candidate if approved for a combination
therapy.
Even if any of our product candidates were to receive marketing approval or be
commercialized for use in combination with other existing approved therapies, we would
continue to be subject to multiple risks, such as the possibility that safety, efficacy,
manufacturing or supply issues could arise with these existing therapies. In addition, it is
possible that existing therapies with which our product candidates are approved for use could
themselves fall out of favor or be relegated to later lines of treatment, which could adversely
affect the market perception and acceptance of the combination therapy. In such scenarios, we
may need to identify other potential combination therapies for our product candidates and
conduct additional preclinical and clinical studies before these alternative therapies receive
regulatory approvals for marketing. Additionally, components of the combination therapies,
other than our product candidates, may not be under our control, and it is possible that we may
encounter difficulties in obtaining sufficient quantities for clinical trials or, when
commercialized, patients may not have adequate access to such components for their treatment
regimes. Historically, we had not experienced shortages of supply that affected our
development of combination therapies, however, in any of aforementioned scenarios, the
development efforts and commercialization prospects regarding our product candidates would
be impaired, which would have an adverse effect on our business, financial condition, results
of operations and growth prospects.
If we encounter difficulties enrolling participants in our clinical trials, our clinical
development activities could be delayed or otherwise adversely affected.
The timely completion of clinical trials in accordance with their protocols depends,
among other things, on our ability to enroll enough participants who remain in the trial until
its conclusion. We may experience difficulties in participant enrollment in our clinical trials for
a variety of reasons, including the size and nature of the patient population and the patient
eligibility criteria defined in the clinical trial protocol, the resources we have to facilitate
timely subject enrollment in our clinical trials, the efforts made by trial execution personnel
including our CROs to screen and recruit eligible subjects, the ability to obtain and maintain
informed consents, epidemics, and the proximity and availability of clinical trial sites for
prospective subjects, among others.
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In addition, our clinical trials may compete with other clinical trials for drug candidates
that are in the same therapeutic areas as our drug candidates. Such competition will likely
reduce the number and types of patients available to us, because some patients who might have
opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our
competitors. Even if we are able to enroll a sufficient number of subjects in our clinical trials,
delays in subject enrollment may result in increased costs or may affect the timing or outcome
of the planned clinical trials, which could delay or prevent the completion of these trials and
adversely affect our ability to advance the development of our drug candidates.
Interim and/or preliminary data derived from our clinical trials that we announce or
publish from time to time may change as more valid data becomes available and are
subject to verification procedures that could result in material changes in the final results.
From time to time, we may publish interim and/or preliminary data from our clinical
trials. Interim data from clinical trials that we may complete are subject to the risk that one or
more of the clinical outcomes may materially change as patient enrollment continues and more
patient data become available. Preliminary data also remain subject to verification procedures
that may result in the final data being materially different from the preliminary data we
previously published. As a result, interim and preliminary data should be viewed with caution
until the final data are available. Differences between preliminary or interim data and final data
could significantly affect our business prospects and may cause the trading price of H Shares
to fluctuate significantly after the Global Offering.
Our preclinical programs may experience delays or may never advance to clinical trials,
which would adversely affect our ability to obtain regulatory approvals or commercialize
these drug candidates on a timely basis or at all, which would have an adverse effect on
our business.
Many of our product candidates are still in the preclinical development stage, and the risk
of failure of preclinical programs is high. Before we can commence clinical trials for a product
candidate, we must complete extensive preclinical testing and studies to obtain regulatory
clearance to initiate human clinical trials. We cannot be certain of the timely completion or
outcome of our preclinical testing and studies and cannot predict if the FDA, the NMPA, the
EMA or other regulatory authorities will accept our proposed clinical programs or if the
outcome of our preclinical testing and studies will ultimately support the further development
of our programs. As a result, we cannot be sure that we will be able to submit IND applications
or similar applications for the contemplated clinical development of our preclinical drug
candidates on the timelines we expect, if at all, and we cannot be sure that submission of IND
applications or similar applications will result in the FDA, the NMPA, the EMA or other
regulatory authorities allowing clinical trials to begin.
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We may allocate our limited resources to pursue particular drug candidates or indications
and fail to capitalize on drug candidates or indications that may later prove to be more
profitable or for which there is a greater likelihood of success.
As we have limited financial and managerial resources, we focus our product pipeline on
research programs and drug candidates that we identify for selected indications. As a result, we
may forgo or delay pursuit of opportunities with other drug candidates or for other indications
that may later prove to have greater commercial potential or a greater likelihood of success.
Our investments in current and future research and development programs and drug candidates
for selected indications may not yield commercially viable products. Furthermore, if we do not
accurately evaluate the commercial potential or target market for a particular drug candidate,
we may relinquish valuable rights to that drug candidate through licensing, collaboration or
royalty arrangements in cases where it would have been more advantageous for us to retain sole
development and commercialization rights to such drug candidate, or we may allocate internal
resources to a drug candidate in a therapeutic area in which it would have been more
advantageous to enter into a partnering arrangement.
We invest substantial human and capital resources in research and development to
develop our pipeline products, but we cannot guarantee that such efforts will lead to
successful outcomes.
The global biopharmaceutical market is constantly evolving, and we must keep pace with
new technologies and methodologies to maintain our competitive position. For example, we
have made efforts to develop our pipeline products. For the years ended December 31, 2023
and 2024 and four months ended April 30, 2024 and 2025, our R&D costs were RMB312.7
million, RMB332.1 million and RMB142.3 million and RMB69.8 million, respectively. We
intend to continue to strengthen our technical capabilities in CMC, technology platforms and
the development of our existing and future drug candidates, which requires substantial capital
and time investment. We cannot assure you that we will be able to develop, improve or adapt
to new technologies and methodologies, successfully identify new technological opportunities,
develop and bring new or enhanced products to market, or obtain sufficient or any patent or
other intellectual property protection for such new or enhanced products in a timely and
cost-effective manner. Any failure to do so may render our previous efforts obsolete, which
could significantly reduce the competitiveness of our technology platforms and drug
candidates, and harm our business and prospects.
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We may fail to sufficiently and promptly respond to rapid scientific and technological
changes, clinical demand and market changes in the pharmaceutical industry, and we may
be unable to maintain or enhance our market share in this industry for a variety of
reasons.
The global pharmaceutical industry is characterized by rapid advances in science and
technology and the continuous emergence of new treatment options. Our future success
partially depends on our ability to launch new products that meet evolving market demands, in
particular, new drugs that are effective in treating oncology and immunology diseases. We
cannot assure you that we will be able to respond to emerging or evolving trends by improving
our product portfolio in a timely manner, or at all.
In addition, clinical demand for pharmaceutical products may change rapidly and
significantly. Our success depends on our ability to anticipate product offering lead-time and
demand, identify preferences of patients and physicians and adapt our products to these
preferences. We may need to adjust our research and development plan, production scale and
schedule, product portfolio, and inventory levels based on market demand, sales trends and
other market conditions. There can be no assurance that we will be able to sufficiently and
promptly respond to changes in clinical demand and purchasing patterns in the future, and such
failure may have a material and adverse effect on our business, financial condition, results of
operations and profitability.
The pharmaceutical industry is highly competitive and fragmented. We face competition
from both domestic and international competitors across most of our product lines based on
safety and efficacy, the timing and scope of the regulatory approvals, prices, sales and
marketing capabilities, the availability and cost of supply, patent position and other factors. In
general, we have faced and will continue to face pricing competition from domestic
competitors, and competition on product quality and brand recognition from international
competitors. In particular, some of our domestic competitors may have, among other things,
greater pricing flexibility and more robust sales networks, which may enable them to offer
products with similar functions but lower prices to the end users. We may not be able to
successfully compete with our competitors and cannot ensure you that we will be able to
demonstrate compelling advantages in safety and efficacy to overcome price competition and
to be commercially successful.
If we cannot maintain or develop clinical collaborations and relationships with our
principal investigators, key opinion leaders, physicians and experts, our results of
operations and prospects could be adversely affected.
Our relationships with principal investigators (“ PIs”), key opinion leaders (“ KOLs ”),
physicians and experts play an important role in our research and development and future
marketing activities. We have established extensive interaction channels with PIs, KOLs,
physicians and experts to gain first-hand knowledge of clinical needs and clinical practice
trends, which is critical to our ability to develop new market-responsive drugs. However, we
cannot assure you that we will be able to maintain or strengthen our clinical collaborations and
relationships with our PIs and KOLs, physicians and experts, or that our efforts to maintain or
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strengthen such relationships will yield the successful development and marketing of new
products. These industry participants may leave their roles, change their business or practice
focus, choose to no longer cooperate with us or cooperate with our competitors instead. Even
if they continue to cooperate with us, their market insights and perceptions, which we take into
account in our research and development process, may be inaccurate and lead us to develop
products that do not have significant market potential. Moreover, we cannot assure you that our
academic promotion and marketing strategy will continue to serve as an effective marketing
strategy. Industry participants may no longer want to collaborate with us and our marketing
strategy may no longer be able to yield results that are commensurate to our efforts spent. If
we are unable to develop new drugs or generate returns from our relationships with industry
participants as anticipated, or at all, our business, financial condition and results of operations
may be materially and adversely affected.
All material aspects of the research, development, manufacturing and commercialization
of pharmaceutical products are heavily regulated. Any failure to comply with relevant
laws and regulations may adversely affect our business, financial condition, results of
operations and prospects.
All jurisdictions in which we intend to conduct our biopharmaceutical industry activities
regulate these activities in great depth and detail. These jurisdictions strictly regulate the
pharmaceutical industry, and in doing so they employ extensive regulations governing the
development, approval, manufacturing, marketing, sales and distribution of pharmaceutical
products. For additional information, see “Regulations” in this Prospectus. Differences in
regulatory regimes across jurisdictions may lead to a higher compliance burden.
The process of obtaining regulatory approvals and maintaining compliance with
appropriate laws and regulations requires spending of substantial time and financial resources.
Any recently enacted and future legislation may increase the difficulty and cost of us to obtain
regulatory approval of, and commercialize, our drug candidates, and affect the prices we may
obtain. Changes in government regulations or in practices relating to the pharmaceutical
industry, such as a relaxation in regulatory requirements; the introduction of simplified
approval procedures, which would lower the entry barrier for potential competitors; or an
increase in regulatory requirements, which may increase the difficulty for us to satisfy such
requirements, may have a material adverse impact on our business, financial condition, results
of operations, and prospects.
Failure to comply with the applicable requirements at any time during the drug
development process or approval process, or after approval, may subject us to administrative
or judicial sanctions. These sanctions could include, but are not limited to, a regulator’s refusal
to approve pending applications, withdrawal of an approval, license revocation, a clinical hold,
voluntary or mandatory product recalls, product seizures, total or partial suspension of
production or distribution, injunctions, fines, refusals of government contracts, restitution,
disgorgement or civil or criminal penalties. Any occurrence of the foregoing could therefore
materially adversely affect our business, financial condition, results of operations and
prospects.
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The regulatory approval processes for pharmaceutical products are time consuming and
depend on numerous factors, and if we are ultimately unable to obtain regulatory
approval for our pipeline products, our business could be substantially harmed.
The regulatory approval processes of pharmaceutical products depend on numerous
factors, some of which may be outside our control. Generally, such approvals take years to be
obtained following the commencement of preclinical studies and clinical trials. Approval
policies, regulations or the type and amount of clinical data necessary to gain approval may
change during the course of a drug candidate’s clinical development and may vary among
jurisdictions. While our Core Product GFH925 received NDA approval from the NMPA, we
may not obtain marketing approval in other markets for GFH925, and we cannot guarantee that
we will be able to obtain regulatory approvals for our other existing drug candidates or any
drug candidates we may discover in the future.
Our pipeline products could fail to receive the regulatory approval of the NMPA, the
FDA, the EMA or a comparable regulatory authority for many reasons, including but not
limited to:
 disagreement with the design or implementation of our clinical trials;
 failure to demonstrate that a drug candidate is safe and effective and potent for its
proposed indication;
 failure of our clinical trial results to meet the level of statistical significance
required for approval;
 failure of our clinical trial process to pass relevant GCP inspections;
 disagreement with our interpretation of data from preclinical studies or clinical
trials;
 insufficient data collected from the clinical trials of our drug candidates to support
the submission and filing of an NDA or other submissions or to obtain regulatory
approval;
 failure of the manufacturer of our drug candidates to pass GMP inspections during
the regulatory review process or across the production cycle of our drug candidates;
 failure of our clinical sites to pass audits carried out by the NMPA, the FDA, the
EMA or other comparable regulatory authorities, resulting in a potential invalidation
of our research data;
 changes in approval policies or regulations that render our preclinical and clinical
data insufficient for obtaining approvals; or
 failure of our clinical trial process to keep up with any scientific or technological
advancements required by approval policies or regulations.
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The NMPA, the FDA, the EMA or a comparable regulatory authority may require more
information, including additional preclinical or clinical data, to support approval, which may
delay or prevent approval and our commercialization plans. Even if we were to obtain
approval, regulatory authorities may approve any of our drug candidates for fewer or more
limited indications than we request, grant approval contingent on the performance of costly
post-marketing clinical trials, or approve a drug candidate with an indication that is not
desirable for the successful commercialization of that drug candidate. Any of the foregoing
scenarios could materially harm the commercial prospects of our drug candidates.
RISKS RELATING TO DEPENDENCE ON THIRD PARTIES
We depend on third parties to provide a stable and adequate supply of investigational
drugs for our research and development efforts and supply of APIs for commercial sales.
Any disruptions of or significant price increases in such supply could adversely affect our
business.
During the Track Record Period, we did not have in-house manufacturing facility and we
outsourced manufacturing activities to reputable third-party manufacturing service providers.
Going forward, we may continue to engage third-party CMOs and CDMOs to manufacture a
portion of our pipeline products for research and development activities and commercial sales.
For instance, we engage third-party manufacturing service providers to provide the APIs for
commercial sales. In particular, we rely on third party manufacturers for the production of
GFH925 supplied to Innovent for commercial sales. During the Track Record Period, the costs
incurred in fulfilling drug supply arrangements for GFH925 exceeded the corresponding
revenue from our sales of GFH925 to Innovent, mainly because production was based on the
first-generation CMC process, which had a higher cost profile than the selling price to
Innovent. To reduce the production cost, we are actively developing a second-generation
manufacturing process, which we expect to adopt in 2026. We anticipate the second-generation
manufacturing process, which is expected to be implemented by third party manufacturers, will
lead an improvement in the current loss-making status of our drug supply. However, we cannot
assure you that there will not be delay or failure in developing and implementing this
cost-effective production method of GFH925. Our engagement with third-party CMOs and
CDMOs exposes us to certain risks, including but not limited to the following:
 we may be unable to identify manufacturers on acceptable terms or at all because the
number of potential manufacturers is limited and the NMPA, the FDA, the EMA or
other comparable regulatory authorities must evaluate and/or approve any
manufacturers as part of their regulatory oversight of our drug candidates. This
evaluation would require new testing and GMP-compliance inspections by the
NMPA, the FDA, the EMA or other comparable regulatory authorities;
 our third-party manufacturers might be unable to timely manufacture our drug
candidates or produce the quantity and quality required to meet our clinical and
commercial needs, if any;
 manufacturers may not be able to execute our manufacturing procedures and other
logistical support requirements appropriately, or may otherwise fail to perform as
agreed;
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 manufacturers are subject to ongoing periodic unannounced inspection by the
regulatory authorities to ensure strict compliance with GMP and other government
regulations. We do not have control over third-party manufacturers’ compliance with
these regulations and requirements;
 manufacturers may not properly obtain, protect, maintain, defend or enforce our
intellectual property rights or may use our intellectual property or proprietary
information in a way that gives rise to actual or threatened litigation that could
jeopardize or invalidate our intellectual property or proprietary information or
expose us to potential liability;
 manufacturers may infringe, misappropriate or otherwise violate the patent, trade
secret or other intellectual property rights of third parties;
 manufacturers may experience manufacturing difficulties due to resource constraints
or as a result of labor disputes, unstable political environments, natural or man-made
disasters, or other events beyond control, which may lead to interruption of the
manufacturing process.
As we are exploring combination therapies consisting of our pipeline products and other
drugs developed by third parties, we also depend on such third parties to provide us with access
to certain drug products developed by these collaborators. For example, we entered into a
clinical trial collaboration and supply agreement with Merck Healthcare KGaA (“ Merck ”),
pursuant to which Merck agreed to supply certain amount of cetuximab to us to be used in our
clinical investigation of the GFH925 in combination with cetuximab for the treatment of
NSCLC in Europe. For additional information, see “Business — Core Product GFH925: A
Small Molecule Inhibitor of KRAS G12C — Licenses, Rights and Obligations — Merck
Agreement.”
In the event that our suppliers are unable to provide adequate supplies of products or
services to us, our operations, including in-house CMC functions and the research and
development of our pipeline products, may be adversely affected. We may also be exposed to
the possibility of increased costs, which we may not be able to pass on to purchasers of our
pipeline products and as a result, lower our profitability. Any delay or interruption in the
provision of clinical trial supplies could delay the completion of clinical trials, increase the
costs associated with maintaining clinical trial programs, and, depending upon the period of
delay, require us to begin new clinical trials at additional expense or terminate clinical trials
completely. The risks discussed above could also jeopardize our ability to provide any future
approved drug candidates for commercial sale.
We believe that we have stable relationships with our existing large third-party
manufacturing service providers and collaborators that supply drug products to us. However,
the stability of operations and business strategies of our service providers and collaborators are
beyond our control, and we cannot assure you that we will be able to secure a stable
relationship and high-quality outsourced services or materials. If any of our large
manufacturing service providers or collaborators terminates its business relationship with us,
we may encounter difficulty in finding a replacement that can provide services or materials of
equal quality at a similar price, and our operations, financial position and business prospect
may be materially and adversely affected.
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We may face difficulties in forming additional collaboration and strategic alliances in the
future.
We have in the past formed and may in the future form or seek strategic alliances, create
collaborations, or enter into additional licensing arrangements with third parties that we
believe will complement or augment our development and commercialization efforts with
respect to our other drug candidates and any future drug candidates that we may develop. Any
of these relationships may require us to incur non-recurring and other charges, increase our
near and long-term expenditures, issue securities that dilute our existing shareholders, or
disrupt our management and business.
We face significant competition in seeking appropriate strategic partners and the
negotiation process is time-consuming and complex. Whether we reach a definitive agreement
for a collaboration, partnership, licenses or other arrangement will depend, among other things,
upon our assessment of the collaborator’s resources and expertise, the terms and conditions of
the proposed collaboration, partnership, licenses or other arrangement and the proposed
collaborator’s evaluation of a number of factors. These factors may include the design or
results of clinical trials, the likelihood of approval by the NMPA, the FDA, the EMA or
applicable regulatory authorities, the potential market for the subject product candidate, the
costs and complexities of manufacturing and delivering such product candidate to patients, the
potential of competing products and the existence of uncertainty with respect to its ownership
of technology, which can exist if there is a challenge to such ownership without regard to the
merits of the challenge and industry and market conditions generally. Moreover, we may not
be successful in our efforts to establishing or maintaining our collaborations, partnerships,
licenses or other arrangements for our drug candidates because they may be deemed to be at
too early of a stage of development for collaborative effort and third parties may not view our
drug candidates as having the requisite potential to demonstrate safety and efficacy or
commercial potential. If and when we collaborate with a third party for the development and
commercialization of a drug candidate, we can expect to relinquish some or all of the control
over the future success of that drug candidate to the third party.
RISKS RELATING TO COMMERCIALIZATION AND MANUFACTURING OF OUR
PIPELINE PRODUCTS
We have no experience in launching and marketing drug products and may not be able
to successfully do so in the future.
While GFH925 is approved for marketing in China, our collaborator Innovent will be
solely responsible for the commercialization activities. For risks associated with this
arrangement, see “— Risks Relating to Dependence on Third Parties — We rely on our current
and future collaborators’ willingness and ability to devote resources to the development and
commercialization of our Core Products and other pipeline products and to otherwise support
our business as contemplated in our collaboration agreements, and we may not have adequate
control over patents and patent applications covering the drug candidates that involve our
current and future collaborators.” Since none of our other pipeline products has reached the
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commercialization stage, we have not yet demonstrated an ability to launch and commercialize
drug products. Given our lack of experience, we may require a longer time frame or be less
cost-efficient in the commercialization process than a company with more experience
launching and marketing drug products. This inexperience may subject our business operations
to greater risk. We cannot assure you that we will succeed in the commercialization process.
Furthermore, if we are unable to, or decide not to, further develop internal sales,
marketing and commercial distribution capabilities for any or all of our drug candidates, we
will likely pursue collaborative arrangements regarding the sales and marketing of our pipeline
products. However, there can be no assurance that we will be able to establish or maintain such
collaborative arrangements, or if we are able to do so, that they will have effective sales forces.
If we choose to pursue this path, we may have little or no control over the marketing and sales
efforts of such third parties beyond contractual terms, and our revenue from product sales may
be lower than if we had commercialized our drug candidates ourselves. We also face
competition in our search for third parties to assist us with the sales and marketing efforts for
our drug candidates. We will have to compete with other pharmaceutical companies to recruit,
hire, train and retain marketing and sales personnel and any revenue we receive will depend
upon the efforts of such third parties. Therefore, we cannot assure you that we will be able to
establish or maintain relationships with third-party partners to successfully commercialize any
product. As a result, we may not be able to generate the anticipated product sales revenue.
The size of the actual markets for our pipeline products may be smaller than our estimates
and our pipeline products may not be able to achieve the degree of market acceptance by
physicians, patients, third-party payers and others in the medical community that would
be necessary for their commercial success.
Our projections of the number of patients who have the potential to benefit from treatment
with our pipeline products are based on our beliefs and estimates. These estimates have been
derived from a variety of sources, including scientific literature and market research, and may
prove to be incorrect. Further, new studies may change the estimated incidence or prevalence
of these diseases. The number of patients may turn out to be fewer than expected. As a result,
the potentially addressable patient population and market size for our pipeline products may be
smaller than our estimates.
Furthermore, there is no guarantee that any of our pipeline products, even if approved,
would be approved for the line of therapy we are ultimately aiming for. For example, oncology
therapies may be characterized as first line, second line or later line therapy depending on
options for treatment and prior treatments received. For indications with well-established
standard of care therapies, the NMPA, the FDA, the EMA and other comparable regulatory
authorities may approve new therapies initially only for second or later lines of therapy. While
we may seek approval for our pipeline products as an early-line therapy for certain indications,
there is no guarantee that they will be approved as such. As a result, even if we obtain market
approval for our drug candidates, we may not achieve the anticipated market size and revenue
unless such market approval is for the intended lines of therapy or for additional indications.
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Additionally, our pipeline products may not be able to gain sufficient market acceptance
in the medical community and physicians, patients or third-party payers may prefer other
products to ours. If our pipeline products do not achieve an adequate level of acceptance, we
may not realize sufficient income from sales that turns us profitable. The degree of market
acceptance of our pipeline products, once approved for commercial sale, will depend on a
number of factors, including, but not limited to:
 the clinical indications for which our pipeline products are approved;
 physicians, hospitals, medical treatment centers and patients considering our
pipeline products;
 efficacy and safety profile of our pipeline products;
 the potential and perceived advantages of our pipeline products over alternative
treatments;
 the prevalence and severity of any side effects;
 limitations or warnings contained in the labeling approved by regulatory authorities;
 the timing of market introduction of our pipeline products as well as competitive
drugs;
 the cost of treatment in relation to alternative treatments;
 the availability of adequate coverage, reimbursement and pricing by third-party
payers and government authorities;
 price control or downward adjustment by the government authorities or other pricing
pressure;
 relative convenience and ease of administration, including as compared to
alternative treatments and competitive therapies;
 the willingness of patients to pay out-of-pocket in the absence of coverage and
reimbursement by third-party payers and government authorities; and
 the effectiveness of sales and marketing efforts regarding our pipeline products and
competing drug products.
Even if our approved pipeline products achieve market acceptance, such market
acceptance may not be maintained over time if new drug products or technologies are
introduced that are more favorably perceived than our pipeline products, have better safety and
efficacy profiles or render our drug candidates obsolete. Inability to achieve and maintain
market acceptance for our pipeline products could materially adversely affect our business,
financial condition, results of operations and prospects.
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Inability to conduct effective sales and marketing activities either by ourselves or through
third parties would negatively affect the sales volume of our pipeline products after they
are approved for commercialization, and our operations, revenue, profitability and
business prospects could be adversely affected.
Successful sales and marketing are crucial to increase the market penetration of our
pipeline products after they are commercialized, expand coverage of hospitals and other
medical institutions and promote new products in the future. If we or our collaborators are
unable to increase or maintain the effectiveness and efficiency of sales and marketing
activities, the sales volumes and business prospects could be adversely affected.
In particular, sales and marketing efforts regarding our pipeline products, once they are
commercialized, will consist of raising awareness and knowledge of our products and product
candidates among medical professionals, hospitals, other medical institutions and pharmacies.
Therefore, the sales and marketing force must possess a relatively high level of technical
knowledge, up-to-date understanding of industry trends, necessary expertise in the relevant
therapeutic areas and products, as well as sufficient promotion and communication skills. If we
or our commercialization collaborators are unable to effectively train the sales representatives,
sales and marketing of our pipeline products may be less successful than desired.
Moreover, to the ability to attract, motivate and retain a sufficient number of qualified
sales professionals, either by us or by our collaborators, is important. Competition for
experienced marketing, promotion and sales personnel is intense. If we or our collaborators are
unable to attract, motivate and retain a sufficient number of marketing, promotion and sales
professionals, sales volume of our products may be adversely affected, and we may be unable
to expand our hospital coverage or increase our market penetration as contemplated.
The commercialization of our pipeline products, if approved, may be subject to
uncertainties from national, provincial or other third-party drug reimbursement
practices and unfavorable drug pricing policies or regulations, which could harm our
business.
The regulations that govern regulatory approvals, pricing and reimbursement for new
therapeutic products vary widely from jurisdiction to jurisdiction. In China and some other
markets, the pricing of drug products remains subject to continuing governmental control even
after initial approval, and the pricing negotiations can take considerable time. As a result, the
commercial launch of our drug candidates, once approved, can be delayed due to price
regulation, which will negatively impact our revenues. The ability to commercialize any
approved drug candidates successfully also will depend in part on the extent to which
reimbursement for these drugs and related treatments will be available from government health
administration authorities, private health insurers and other organizations.
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A primary trend in the global healthcare industry is cost containment. Government
authorities and these third-party payers have attempted to control costs by limiting coverage
and the amount of reimbursement for particular medications. Increasingly, third-party payers
are requiring that companies provide them with predetermined discounts from list prices and
are challenging the prices charged for medical products. We cannot be sure that reimbursement
will be available for any commercialized pipeline products and, if reimbursement is available,
what the level of reimbursement will be. Reimbursement may impact the demand for, or the
price of, any approved drug candidates that we commercialize. Obtaining or maintaining
reimbursement for our future approved pipeline products may be difficult. If reimbursement is
not available or is available only to limited levels, we may not be able to successfully
commercialize any drug candidates that we successfully develop.
There may be significant delays in obtaining reimbursement for approved drug
candidates, and coverage may be more limited than the purposes for which the drug candidates
are approved by the NMPA, the FDA, the EMA or other comparable regulatory authorities. For
instance, in the United States, no uniform policy of coverage and reimbursement for drugs
exists among third-party payers. As a result, obtaining coverage and reimbursement approval
of a drug from a government or other third-party payer is a time-consuming and costly process
that could require us to provide to each payer supporting scientific, clinical and cost-
effectiveness data for the use of our approved pipeline products on a payer-by-payer basis, with
no assurance that coverage and adequate reimbursement will be obtained. Even if we obtain
coverage for a given drug, the resulting reimbursement rates might not be adequate for us to
achieve or sustain profitability or may require co-payments that patients find unacceptably
high.
Moreover, eligibility for reimbursement does not imply that any drug will be paid for in
all cases or at a rate that covers our costs, including research, development, manufacture, sale
and distribution. Interim payments for new drugs, if applicable, may also not be sufficient to
cover our costs and may not be made permanent. Payment rates may vary according to the use
of the drug and the clinical setting in which it is used, may be based on payments allowed for
lower cost drugs that are already reimbursed, and may be incorporated into existing payments
for other services. Net prices for drugs may be reduced by mandatory discounts or rebates
required by government healthcare programs or private payers and by any future weakening of
laws that presently restrict imports of drugs from countries where they may be sold at lower
prices. Our inability to promptly obtain coverage and profitable payment rates from both
government-funded and private payers for any future approved drug candidates or any new
drugs that we develop could have a material adverse effect on our business, our results of
operation, and our overall financial condition.
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Guidelines, recommendations and studies published by various organizations could
disfavor our pipeline products.
Government agencies, professional societies, practice management groups, private health
and science foundations and organizations focused on various diseases may publish guidelines,
recommendations or studies that affect our or our competitors’ drugs and drug candidates.
Currently, there are not any unfavorable guidelines, recommendations and studies published by
various organizations in relation to our pipeline products. However, any such guidelines,
recommendations or studies that reflect negatively on our pipeline products, either directly or
relative to competing drug products, could result in current or potential decreased use and/or
sales of, and revenue from one or more of our pipeline products. Furthermore, our success
depends in part on the ability to educate healthcare providers and patients about our pipeline
products, and these education efforts could be rendered ineffective by, among other things,
third parties’ guidelines, recommendations or studies.
We may not be able to maintain effective quality control and quality assurance over our
drug products.
During the Track Record Period, we primarily procured third-party manufacturing
services to produce pipeline products for clinical development. For risks associated with
third-party manufacturing, see “— Risks Relating to Dependence on Third Parties — We
depend on third parties to provide a stable and adequate supply of investigational drugs supply
for our research and development efforts and supply of APIs for future commercial sales. Any
disruptions of or significant price increases in such supply could adversely affect our
business.” The quality of drug products manufactured by the third-party service providers will
depend significantly on the effectiveness of our established standards and protocol of quality
control and quality assurance, which in turn depends on factors such as the production
processes used in the manufacturing facilities, the quality and reliability of equipment used, the
quality of manufacturing staff and related training programs and the ability to ensure that the
manufacturing staff adheres to quality control and quality assurance protocol. We have been
refining the CMC aspects of our pipeline products to establish manufacturing processes that
ensure the pipeline products, from a manufacturing perspective, to be safe and with consistent
quality, even in a setting of scaled-up and repeated manufacturing. However, we cannot assure
you that the established quality control and quality assurance procedures will be effective in
consistently preventing and resolving deviations from our quality standards or that our standard
operating procedures will be complete or updated at all times. We may be unable to detect or
cure quality defects as a result of a number of factors, many of which are outside our control,
including but not limited to:
 manufacturing errors;
 technical or mechanical malfunctions in the manufacturing process;
 human error or malfeasance;
 tampering by third parties; and
 quality issues with the raw materials we purchase or produce.
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Any significant failure or deterioration of our quality control and quality assurance
protocol or standard operating procedures could render our products unsuitable for use, result
in gaps in the audit of our processes, jeopardize any GMP certifications we may have in the
future and/or harm our market reputation and relationship with business collaborators. Any
such developments may have a material adverse effect on our business, financial condition and
results of operations.
We have limited experience in manufacturing pharmaceutical products, including
scaled-up product formulation and filling, and our business could be materially and
adversely affected if we encounter problems in manufacturing our future pipeline
products.
We have limited experience in manufacturing biopharmaceutical products, which is a
complex process requiring significant expertise and capital investment, in part due to strict
regulatory requirements. While we currently plan to continue to engage third-party
manufacturing service providers to produce the APIs, we intend to carry out certain aspects of
drug manufacturing, including final drug product formulation and filling, for certain pipeline
products in-house in the future. V arious problems may arise during the manufacturing for a
variety of reasons, including but not limited to:
 equipment malfunction;
 failure to follow specific protocols and procedures;
 changes in product specification;
 low quality or insufficient supply of APIs;
 changes in the types of products produced;
 advances in manufacturing techniques;
 inability to procure adequate raw materials from our suppliers, or inability to do so
at a reasonable cost; and
 man-made or natural disasters and other environmental factors.
Furthermore, if contaminants are discovered in our pipeline products or in the
manufacturing facilities, such manufacturing facilities may need to be closed for an extended
period of time to investigate and remedy the contamination. We cannot assure you that any
stability failures or other issues relating to the manufacture of our pipeline products will not
occur in the future, either relating to our third-party CDMOs or on our manufacturing facilities
we plan to build in the future. If problems arise during the production process of a drug
product, a batch or several related batches of such product may have to be discarded and cause
production delays, cost increases, lost revenue and damage to customer relationships and our
reputation. If problems are not discovered before the relevant products are released for the
clinical development or to the market, we may incur additional costs in connection with
product recalls and product liability.
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Manufacturing methods and formulations are sometimes altered through the development
of drug candidates from clinical trials to approval, and further to commercialization, in an
effort to optimize manufacturing processes and results. Such changes carry the risk that they
will not achieve these intended objectives. Any of these changes could cause the drug
candidates to perform differently and affect the results of planned clinical trials or other future
clinical trials conducted with the altered materials. This could delay the commercialization of
drug candidates and require bridging studies or the repetition of one or more clinical trials,
which may result in increases in clinical trial costs, delays in drug approvals and jeopardize our
ability to commence product sales and generate revenue.
We may also encounter problems with achieving adequate products that meet the NMPA,
the FDA, the EMA or other comparable regulatory agency standards or specifications, and
maintaining consistent and acceptable production costs. We may also experience shortages of
qualified personnel, raw materials or key contractors, and experience unexpected damage to
our facilities or equipment. In these cases, we may be required to delay or suspend our future
manufacturing activities. We may be unable to secure temporary, alternative manufacturers for
our drugs with the terms, quality and costs acceptable to us, or at all. Moreover, we may spend
significant time and costs to remedy these deficiencies before we can continue production at
our manufacturing facilities. Occurrence of such events would restrict our manufacturing
capacity and could delay our clinical trials and/or the availability of our products for
commercial sale, or render us unable to meet the increasing demand for our drug candidates
and future drug products, and may materially and adversely affect our business and financial
condition.
Our planned establishment of manufacturing facilities may not be as successful as we
have planned.
As we accumulate deeper experience in CMC and advance more pipeline products to later
stages of development, we plan to establish manufacturing facilities to internalize certain
aspects of drug product manufacturing, including formulation production and filling, for
certain pipeline products. We are also advancing the development of the second-generation
manufacturing process for GFH925 and are fully responsible for all aspects of the process. As
of the Latest Practicable Date, we were in the process of formulating a detailed establishment
plan and had not acquired a parcel of land to construct the facilities. The completion of such
a contemplated facility establishment plan will involve regulatory approvals and reviews by
various authorities, including, but not limited to, urban planning, construction and
environmental protection authorities. We cannot assure you that we will be able to obtain all
of the required approvals, permits and licenses. In addition, the establishment of the
contemplated manufacturing facilities also may not be completed on the anticipated timetable
or within budget. Cost overruns associated with constructing or maintaining our facilities could
require us to raise additional funds from other sources. We may also be unable to fully utilize
the production capacity after we construct the facilities. Any of the foregoing factors could
materially and adversely affect our results of operations and prospects.
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Our future manufacturing facilities may be subject to ongoing, periodic inspection by the
NMPA, the FDA, the EMA or other comparable regulatory agencies to ensure compliance with
applicable GMP standards. Our failure to follow and document our adherence to such GMP
regulations or other regulatory requirements may lead to significant delays in the availability
of products for clinical or, in the future, commercial use, may result in the termination of or
a hold on a clinical trial, or may delay or prevent filing or approval of marketing applications
for our drug candidates or the commercialization of our drugs, if approved.
Should deficiencies or manufacturing issues arise in our future manufacturing facilities,
or instances of failure to comply with applicable regulations occur, we may also be subject to
sanctions for failure to comply with applicable regulations, including fines, injunctions,
penalties, suspension of clinical trials, failure of regulatory authorities to grant marketing
approval of our drug candidates, suspension or withdrawal of approvals, supply disruptions,
seizures or recalls of our pipeline products, or operating restrictions, any of which may harm
our operations, financial position and business prospect.
RISKS RELATING TO OUR INTELLECTUAL PROPERTY RIGHTS
Our patent rights may be challenged and invalidated.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or
enforceability, and our patent rights may be challenged in the courts or patent offices in China,
the U.S., the EU and other jurisdictions. We may be subject to claims that former employees,
collaborators or other third parties have an interest in our patents or other intellectual property
or become involved in opposition, derivation, revocation, reexamination, post-grant and inter
partes review, or interference proceedings challenging our patent rights or the patent rights of
others. If we are unsuccessful in any interference proceedings or other priority or validity
disputes (including any patent oppositions) to which our intellectual properties are subject, we
may lose valuable intellectual property rights through the loss of one or more patents or our
patent claims may be narrowed, invalidated, or held unenforceable. In addition, if we are
unsuccessful in any inventorship disputes to which we are subject, we may lose valuable
intellectual property rights, such as exclusive ownership. If we are unsuccessful in any
interference proceeding or other priority or inventorship dispute, we may be required to obtain
and maintain licenses from third parties, including parties involved in any such interference
proceedings or other priority or inventorship disputes. Such licenses may not be available on
commercially reasonable terms or at all, or may be non-exclusive. If we are unable to obtain
and maintain such licenses, we may need to cease the development, manufacture and
commercialization of one or more of our drug candidates. The loss of exclusivity or the
narrowing of our patent claims could limit our ability to stop others from using or
commercializing similar or identical drug products. Any of the foregoing could result in a
material adverse effect on our business, financial condition, results of operations or prospects.
Even if we are successful in an interference proceeding or other similar priority or inventorship
disputes, it could result in substantial costs and be a distraction to our management and other
employees.
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Patent protection depends on compliance with various procedural, regulatory and other
requirements, and our patent protection could be reduced or eliminated due to
non-compliance.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental
fees on patents and patent applications are due to be paid to the China National Intellectual
Property Administration (the “ CNIPA”), the United States Patent and Trademark Office (the
“USPTO ”) and other applicable patent agencies in several stages over the lifetime of a patent.
The CNIPA, the USPTO and other applicable patent agencies require compliance with a
number of procedural, documentary, fee payment, and other similar provisions during the
patent application process. Although an inadvertent lapse can in many cases be cured by
payment of a late fee or by other means in accordance with the applicable rules, there are
situations in which non-compliance can result in abandonment or lapse of the patent or patent
application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
Non-compliance events that could result in abandonment or lapse of a patent or patent
application include failure to respond to official actions within prescribed time limits,
non-payment of fees, and failure to properly legalize and submit formal documents. In any such
event, our competitors might be able to enter the market, which would have a material adverse
effect on our business.
If our patent terms expire before or soon after our drug candidates are approved, or if
competitors successfully challenge our patents, our business may be materially harmed.
Patents have a limited duration. Depending on the jurisdiction, various extensions may be
available, but the life of a patent, and the protection it affords, is limited. For example, the
expiration of a patent is generally 20 years for inventions in China and generally 20 years from
the earliest date of filing of the first non-provisional patent application to which the patent
claims priority in the U.S. Even if patents covering our drug candidates, their manufacture, or
use are obtained, once the patent life has expired, we may be open to competition from
competitive medications. The expiration of our issued patents or patents that may issue from
our patent applications, we will not be able to assert such patent rights against potential
competitors and our business and results of operations may be adversely affected. Moreover,
the applicable time period or the scope of patent protection afforded could be less than we
request. If we are unable to obtain a patent term extension or the term of any such extension
is less than we request, our competitors may obtain approval of competing products following
our patent expiration, and our business could be harmed.
In addition, some of our patents and patent applications may, in the future, be co-owned
with third parties. If we are unable to obtain an exclusive license to any such third-party
co-owners’ interest in such patents or patent applications, such co-owners may be able to
license their rights to other third parties, including our competitors, and our competitors could
market competing products and technology. Besides this, we may need the cooperation of any
such co-owners of our patents in order to enforce such patents against third parties, and such
cooperation may not be provided to us. Any of the foregoing could have a material adverse
effect on our competitive position, business, financial condition, results of operations and
prospects.
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Lack of protection under the applicable patent linkage and patent term extension laws
and regulations could increase the risk of early generic competition.
In the United States, the Federal Food, Drug, and Cosmetic Act, as amended by the law
generally referred to as the “Hatch-Waxman Amendments,” provides the opportunity for
patent-term restoration of up to five years to reflect patent term lost during certain portions of
product development and the FDA regulatory review process. The Hatch-Waxman
Amendments also have a process for patent linkage, pursuant to which FDA will stay approval
of certain follow-on applications during the pendency of litigation between the follow-on
applicant and the patent holder or licensee, generally for a period of 30 months. Finally, the
Hatch-Waxman Amendments provide for statutory exclusivities that can prevent submission or
approval of certain follow-on marketing applications. For example, federal law provides a
five-year period of exclusivity within the United States to the first applicant to obtain approval
of a new chemical entity (as defined) and three years of exclusivity protecting certain
innovations to previously approved active ingredients where the applicant was required to
conduct new clinical investigations to obtain approval for the modification. Similarly, the
Orphan Drug Act provides seven years of market exclusivity for certain drugs to treat rare
diseases, where FDA designates the product candidate as an orphan drug and the drug is
approved for the designated orphan indication. These provisions, designed to promote
innovation, can prevent competing products from entering the market for a certain period of
time after FDA grants marketing approval for the innovative product.
In China, the amendment to the PRC Patent Law which was promulgated in October 2020
introduces patent extensions to patents of new drugs that launched in the PRC, which may
enable the patent owner to submit applications for a patent term extension of up to a maximum
length of five years, and after the new drug is approved for marketing, the total effective term
of the patent shall not exceed 14 years. However, we may not be granted an extension because
of, for example, failing to exercise due diligence during the testing phase or regulatory review
process, failing to apply within applicable deadlines, failing to apply prior to expiration of
relevant patents, or otherwise failing to satisfy applicable requirements.
Even if we believe that we are eligible for certain patent term extensions, there can be no
assurance that the relevant governmental authorities will agree with our assessment of whether
such extensions are available, and such authorities may refuse to grant extensions to our
patents, or may grant more limited extensions than we requested. In such instances, a
lower-cost generic drug can emerge onto the market much more quickly, leading to early
generic competition that may have a material and adverse effect on our financial position and
business prospect.
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We may not be able to protect our intellectual property rights or prevent unfair
competition by third parties.
Filing, prosecuting, maintaining and defending patents on drug candidates in all countries
throughout the world could be prohibitively expensive for us, and our intellectual property
rights in some countries can have a different scope and strength than do those in some other
countries. In addition, the laws of certain countries do not protect intellectual property rights
to the same extent as the laws of certain other countries. Consequently, we may not be able to
prevent third parties from practicing our inventions in all countries, or from selling or
importing drugs made using our inventions in and into certain jurisdictions. Competitors may
use our technologies in jurisdictions where we have not obtained patent protection to develop
their own drugs and further, may be able to circumvent our patents by developing similar or
alternative products and technologies in a non-infringing manner, may develop and
commercialize products and technologies similar or identical to ours and compete directly
against us after the expiration of our patent rights, or may export otherwise infringing drugs
to certain jurisdictions where we have patent protection, but where enforcement rights are not
as strong as those in certain other countries. These drugs may compete with our drug candidates
and our patent rights or other intellectual property rights may not be effective or adequate to
prevent them from competing.
The legal systems of some countries do not favor the enforcement of patents, trade secrets
and other intellectual property, particularly those relating to biopharmaceutical products, which
could make it difficult in those jurisdictions for us to stop the infringement, misappropriation
or other violation of our patents or other intellectual property rights, or the marketing of
competing drugs in violation of our proprietary rights. Proceedings to enforce our intellectual
property and proprietary rights in foreign jurisdictions could result in substantial costs and
divert our efforts and attention from other aspects of our business, could put our patents at risk
of being invalidated or interpreted narrowly, could put our patent applications at risk of not
issuing, and could provoke third parties to assert claims against us. We may not prevail in any
lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be
commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights
around the world may be inadequate to obtain a significant commercial advantage from the
intellectual property that we develop or license. Any of the foregoing could materially
adversely affect our business, financial condition, results of operations and prospects.
We may become subject to intellectual property infringement claims, which could expose
us to substantial liability, harm our reputation, limit our research and development or
other business activities and/or impair our ability to commercialize our product
candidates.
Our commercial success depends significantly on our ability to develop, manufacture,
market and sell pharmaceutical products and use our proprietary technologies without
infringing, misappropriating or otherwise violating the patents and other intellectual property
rights of third parties. The pharmaceutical industry is characterized by extensive litigation
regarding patents and other intellectual property rights. Defending against claims of patent
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infringement, misappropriation of trade secrets or other violations of intellectual property
rights could also be costly and time-consuming, regardless of the outcome. Thus, even if we
were to ultimately prevail, or to settle at an early stage, such litigation could burden us with
substantial unanticipated costs.
The publication of discoveries in scientific or patent literature frequently occurs
substantially later than the date on which the underlying discoveries were made and invention
patent applications are filed. Even after reasonable investigation, we may not know with
certainty whether any third party may have filed a patent application without our knowledge
while we are still developing or producing that product or other relevant technology. We may
become party to, or threatened with, adversarial proceedings or litigation regarding intellectual
property rights with respect to our technology and any product candidates we may develop.
Third parties may assert infringement claims against us based on patents or other
proprietary rights that they currently hold or may be granted in the future, regardless of their
merit. We may receive in the future, notices that claim our technologies or certain other aspects
of our business have infringed, misappropriated or misused other parties’ intellectual property
rights. Whether or not third-party intellectual property claims are without merit, there is no
assurance that a court would find in our favor on questions of infringement, validity,
enforceability or priority. A court of competent jurisdiction could hold that these third-party
patents are valid, enforceable and infringed, which could materially and adversely affect our
ability to commercialize any product candidates we may develop and any other product
candidates or technologies covered by the asserted third-party patents. We are not currently
involved in any material patent litigations. We, however, are aware that a third party’s patent
claims in the U.S. define a group of compounds solely by functional characteristics, without
specifying their chemical structures. The scope of this protection is excessively broad and
appears to cover GFH925, which covalently binds to the KRAS protein. Our legal advisor as
to the U.S. intellectual property laws advised that under the U.S. patent law, functional
languages in patent claims may lead to written description and enablement issues if not
properly supported by the specification, thereby rendering the patent invalid under 35 U.S.C.
§ 112. Here, the functional language in the claims of the U.S. patent defines a broad group of
compounds, and such functional language lacks sufficiently specified corresponding chemical
structures described in the patent specification. Moreover, the actual chemical structures
described in the patent specification are substantially different from that of GFH925.
Accordingly, as advised by our legal advisor as to the U.S. intellectual property laws, we
believe that these broadly defined claims, which are solely based on functional characteristics,
may raise concerns about their validity and enforceability in U.S. courts due to insufficient
enablement and written description support. As a result, the likelihood of these claims having
a significant impact on the freedom to operate GFH925 in the U.S. is low.
Also, under the licensing agreements we entered with Innovent, V erastem and SELLAS,
we, as the licensor, have an obligation to indemnify our collaboration partners for the potential
penalties arising from patent infringement of IP claims asserted by a third party in the licensed
jurisdiction. For example, we have an obligation to indemnify Innovent for the potential
penalties arising from patent infringement of IP claims asserted by a third party in Greater
China. In addition, we have an obligation to indemnify V erastem the potential penalties arising
from patent infringement of IP claims asserted by a third party outside Greater China.
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However, whether a product infringes a patent involves an analysis of complex legal and
factual issues, the determination of which is often uncertain, and the burden of proof required
to successfully challenge a third-party patent may be high. Such legal proceedings, regardless
of their merits, could lead to considerable legal costs and be a distraction to our management.
If we are found to infringe on a third party’s intellectual properties, and we are unsuccessful
in demonstrating that such patents are invalid or unenforceable, one or more of the following
may occur:
 we may have to reformulate the affected product(s) so that it does not infringe the
intellectual property rights of others, which may not be possible or could be very
costly and time-consuming;
 we may be forced to discontinue production and sales of the affected product(s) or
cease developing and commercializing the affected product candidate(s);
 we may be prevented from commercializing our product candidates until the
asserted patent expires or is held finally invalid or not infringed in a court of law;
and
 we may be required to obtain royalty-bearing licenses from such third party to such
patents, which may not be available on commercially reasonable terms, or at all, and
even if we were able to obtain such licenses, they could be non-exclusive, thereby
giving our competitors and other third parties’ access to the same technologies
licensed to us and could require us to make substantial licensing and royalty
payments.
Furthermore, potential disputes with our business partners or collaborators may arise if
we are unable to agree on whether the product candidates under collaboration involve
freedom-to-operate concerns. In addition, some of our competitors are larger than we are and
have substantially greater resources than we do. They are, therefore, likely to be able to sustain
the costs of complex intellectual property litigation longer than we could. In addition, the
uncertainties associated with litigation could have a material adverse effect on our ability to
raise the funds necessary to conduct our clinical trials, continue our internal research projects,
in-license needed technologies, or enter into strategic partnerships that would help us bring our
product candidates to market.
Claims that we have misappropriated the confidential information or trade secrets of third
parties could have a material adverse effect on our business, financial condition, results of
operations, and prospects. Even if we are successful in litigation or administrative proceedings,
such litigation and proceedings may be costly and could result in a substantial diversion of
management resources. If any of the foregoing events occurs, our business may be materially
and adversely affected.
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If our trademarks and trade names are not adequately protected, then we may not be able
to build name recognition in our markets of interest and our business may be adversely
affected.
We own registered trademarks in China and have a pending trademark application in the
United States. Our registered or unregistered trademarks or trade names may be challenged,
infringed, circumvented or declared generic or determined to be infringing on other marks. We
may not be able to protect our rights to these trademarks and trade names, which we need to
build name recognition among potential partners or customers in our markets of interest. At
times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our
ability to build brand identity and possibly leading to market confusion. In addition, there
could be potential trade name or trademark infringement claims brought by owners of other
registered trademarks or trademarks that incorporate variations of our registered or
unregistered trademarks or trade names. Over the long term, if we are unable to establish name
recognition based on our trademarks and trade names, then we may not be able to compete
effectively, and our business may be adversely affected. Our efforts to enforce or protect our
proprietary rights related to trademarks, trade secrets, domain names, copyrights or other
intellectual property may be ineffective and could result in substantial costs and diversion of
resources and could adversely affect our competitive position, business, financial condition,
results of operations, and prospects.
If we are unable to protect the confidentiality of our trade secrets, our business and
competitive position would be harmed.
In addition to our issued patents and patent applications, we rely on trade secrets and
confidential information, including unpatented know-how, technology and other proprietary
information, to maintain our competitive position and to protect our drug candidates. We seek
to protect our trade secrets and confidential information, in part, by entering into non-
disclosure and confidentiality agreements with parties that have access to trade secrets or
confidential information, such as our employees, corporate collaborators, outside scientific
collaborators, CROs, clinical research coordinators, contract manufacturers, consultants,
advisors and other third parties that have access to them.
However, we may not be able to prevent the unauthorized disclosure or use of our trade
secrets and confidential information by the parties to these agreements. Monitoring
unauthorized uses and disclosures is difficult and we do not know whether the steps we have
taken to protect our proprietary technologies will be effective. Any of the parties with whom
we enter into confidentiality agreements may breach or violate the terms of any such
agreements and may disclose our proprietary information, and we may not be able to obtain
adequate remedies for any such breach or violation. As a result, we could lose our trade secrets
and third parties could use our trade secrets to compete with our drug candidates and
technology. Additionally, we cannot guarantee that we have entered into such agreements with
each party that may have or has had access to our trade secrets or proprietary technology and
processes. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret
can be difficult, expensive and time-consuming, and the outcome is unpredictable. If any of our
trade secrets were to be lawfully obtained or independently developed by a competitor or other
third party, we would have no right to prevent them from using that technology or information
to compete with us and our competitive position would be harmed.
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Changes in patent law could diminish the value of patents in general, thereby impairing
our ability to protect our pipeline products.
The laws and regulations governing patents could be revised from time to time that would
affect our ability to obtain new patents or to enforce our existing patents and patents that we
might obtain in the future. Our existing patent rights and future patent applications may face
certain potential influence. Such changes may impact the value of our patent rights or our other
intellectual property rights. For instance, the United States has enacted wide-ranging patent
reform legislation. The United States Supreme Court rulings have narrowed the scope of patent
protection available in certain circumstances and weakened the rights of patent owners in
certain situations. In addition to increasing uncertainty with regard to our ability to obtain
patents in the future, this combination of events has created uncertainty with respect to the
value of patents once obtained, if any.
We may be subject to claims that our employees have wrongfully used or disclosed alleged
trade secrets of their former employers.
Some of our employees and consultants were previously employed at universities or other
biotechnology or pharmaceutical companies, including our competitors or potential
competitors. Although we try to ensure that our employees do not use the proprietary
information or know-how of others in their work for us, we may be subject to claims that we
or our employees have used or disclosed intellectual property, including trade secrets or other
proprietary information, of any such employee’s former employer. Litigation may be necessary
to defend against these claims. If we fail in defending any such claims, in addition to paying
monetary damages, we may lose valuable intellectual property rights or personnel. Even if we
are successful in defending against such claims, litigation could result in substantial costs and
be a distraction to management and our specific personnel.
We may be subject to claims challenging the inventorship of our patents and other
intellectual property.
We may be subject to claims that former employees, collaborators or other third parties
have an interest in our patents, trade secrets, or other intellectual property as an inventor or
co-inventor. For example, we may have inventorship disputes arise from conflicting
obligations of employees, consultants or others who are involved in developing our product
candidates. Also, former employees may become employed by competitors who develop
similar technology, and could assist the competitor in designing around our patents. While we
typically require our employees and contractors who may be involved in the development of
intellectual property to execute agreements assigning such intellectual property to us, we may
be unsuccessful in executing such an agreement with each party who in fact develops
intellectual property that we regard as our own. Our and their assignment agreements may not
be self-executing or may be breached, and litigation may be necessary to defend against these
and other claims challenging inventorship or our ownership of our patents, trade secrets or
other intellectual property. If we fail in defending any such claims, in addition to paying
monetary damages, we may lose valuable intellectual property rights, such as exclusive
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ownership of, or right to use, intellectual property that is important to our product candidates.
Even if we are successful in defending against such claims, litigation could result in substantial
costs and be a distraction to management and other employees. Any of the foregoing could
have a material adverse effect on our business, financial condition, results of operations and
prospects.
Intellectual property rights do not necessarily protect us from all potential threats.
Intellectual property rights do not necessarily protect us from all potential threats,
because intellectual property rights have limitations and may not adequately protect our
business or permit us to maintain our competitive advantage. For example:
 others may be able to make products that are similar to any candidates we may
develop while our candidates are not protected by our intellectual property rights;
 we or our current or future collaborators might not have been the first to develop
drug candidates covered by the issued patent that we license or may own in the
future;
 we or our current or future collaborators might not have been the first to file patent
applications covering certain of our, or their, candidates;
 others may independently develop similar or alternative technologies or duplicate
any of our technologies without infringing, misappropriating or otherwise violating
our owned or licensed (if any) intellectual property rights;
 it is possible that our pending patent applications or those that we may file in the
future will not lead to issued patents;
 issued patents that we hold rights to may not provide us with a competitive
advantage, or may be held invalid or unenforceable, including as a result of legal
challenges by our competitors or other third parties;
 we may obtain patents for certain technologies many years before we commercialize
candidates leveraging such technologies, and because patents have a limited life,
which may begin to run prior to the commercial sale of the related candidates, the
commercial value of our patents may be limited;
 our competitors or other third parties might conduct research and development
activities in jurisdictions where we do not have patent rights and then use the
information learned from such activities to develop competitive products for sale in
our major commercial markets;
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 the validity and scope of any claims relating to copyrights or other intellectual
property may involve complex legal and factual questions and analyses and, as a
result, the outcome may be highly uncertain;
 we may not develop additional proprietary technologies that are patentable; and
 we may choose not to file a patent for certain trade secrets or know-how, and a third
party may subsequently file a patent covering such intellectual property.
Should any of these events occur, it could have a material adverse effect on our
competitive position, business, financial condition, results of operations and prospects.
RISKS RELATING TO OUR FINANCIAL POSITION
We are a biopharmaceutical company with a limited operating history, which may make
it difficult to evaluate our current business and predict our future performance.
We are a biopharmaceutical company with a limited operating history. Our operations to
date have focused on establishing our intellectual property portfolio, conducting drug
discovery, preclinical studies and clinical trials of our drug candidates, organizing and staffing
our operations, business planning and raising capital. To date, we have one product approved
for commercial sale and have not become profitable from product sales.
Our limited operating history, particularly in light of the rapidly evolving drug research
and development industry in which we operate, the inherent uncertainties in drug research and
development, and the changing regulatory and market environments we encounter, may make
it difficult to evaluate our prospects for future performance. Consequently, any predictions
about our future success or viability may not be as accurate as they could be if we had a longer
operating history. We will encounter risks and difficulties frequently experienced by
early-stage companies in rapidly evolving fields as we seek to transition to a company capable
of supporting commercial activities. If we do not address these risks and difficulties
successfully, our business may suffer and you may lose all of your investments in us.
We have incurred significant operating losses since inception, and we anticipate that we
will continue to incur operating losses and may fail to achieve or maintain profitability in
the future. As a result, you may lose substantially all of your investments in us.
Investment in the development of innovative biopharmaceutical products can be highly
speculative as it entails substantial upfront expenditures and significant risks that a drug
candidate may fail to demonstrate efficacy and safety to gain regulatory or marketing approvals
or become commercially viable. During the Track Record Period, while we generated a limited
amount of revenue from the collaboration agreements with Innovent V erastem and SELLAS,
we continue to incur significant research and development costs and other expenses related to
our ongoing operations. As a result, we are not profitable and have incurred operating losses
since our inception. For the years ended December 31, 2023 and 2024 and four months ended
April 30, 2024 and 2025, our total losses were RMB508.3 million, RMB677.6 million and
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RMB404.7 million and RMB66.6 million, respectively. Substantially all of our operating losses
during the Track Record Period resulted from costs and expenses incurred by our research and
development activities, including those in relation to our preclinical studies and clinical trials,
which exceeded the revenue we recognized in the same periods. Our ability to generate revenue
and achieve profitability depends significantly on our success in advancing innovative drug
candidates into later stages of clinical development, and obtaining regulatory approvals for
each drug candidate, which we may not be able to do in a timely manner or at all.
We expect to continue to incur losses in the near future and that these net losses may
increase as we continue to carry out certain activities relating to our development, including
but not limited to the following:
 continue to advance the clinical trials and preclinical studies of our pipeline
products;
 seek regulatory approvals for our pipeline products and commence
commercialization;
 identify additional drug candidates with significant market potential;
 respond to scientific advancements, new technologies and market developments;
 maintain, protect and expand our intellectual property portfolio; and
 enter into additional strategic collaborations to maximize the value of our pipeline
products.
Even if we achieve profitability in the future, we may not be able to sustain profitability
in subsequent periods thereafter. Our operating losses have had, and will continue to have, an
adverse effect on our working capital and shareholders’ equity. Our inability to become and
remain profitable may affect investors’ perception of the potential value of our Company and
could impair our ability to raise additional capital, expand our business or continue our
operations. Failure to become and remain profitable may also adversely affect the market price
of our H Shares. A decline in the market price of our H Shares could cause potential investors
to lose all or part of their investment in our business.
We had net operating cash outflows during the Track Record Period.
Since our inception, our operations have consumed substantial amounts of cash. We had
net cash used in operating activities of RMB202.1 million and RMB206.4 million for the years
ended December 31, 2023 and 2024 and RMB136.9 million and RMB34.0 million for the four
months ended April 30, 2024 and 2025, respectively. Additionally, we are exposed to credit risk
on the cash and cash equivalents deposited in financial institutions. In the event that any of
them becomes insolvent and is taken into receivership by the relevant government agencies,
there will be uncertainty as to the timing and extent to which we will be able to recover our
cash on deposit at such financial institution.
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While we believe we have sufficient working capital to fund our current operations for the
next 12 months, we expect that we may experience net cash outflows from our operating
activities for the foreseeable future. We may need to obtain substantial additional funding in
connection with our continuing operations through public or private equity offerings, debt
financing, collaborations or other sources. Adequate additional funding may not be available
to us on acceptable terms, or at all. If we are unable to raise capital when needed or on
reasonable terms, we could have to delay, limit, reduce or terminate our research and
development programs or any future commercialization efforts. Our inability to obtain
additional funding when we need it could seriously harm our business.
We incurred net liabilities and net current liabilities during the Track Record Period,
which may continue into the foreseeable future and expose us to liquidity risk.
As of December 31, 2023 and 2024 and April 30, 2025, we had net liabilities of
RMB1,317.3 million, RMB1,956.3 million and RMB2,013.6 million, respectively. In addition,
we recorded net current liabilities of RMB1,381.4 million, RMB1,925.2 million and
RMB1,979.8 million as of December 31, 2023 and 2024 and April 30, 2025, respectively. A net
liabilities position can expose us to liquidity and financial risks. This in turn could require us
to seek financing from external sources such as bank borrowings, which may not be available
on terms favorably or commercially reasonable to us, or at all. If we are unable to maintain
adequate working capital or obtain sufficient financings to meet our capital needs, we may be
unable to continue our operations according to our plan, default on our payment obligations
and fail to meet our capital expenditure requirements, which may have a material adverse effect
on our business, financial condition, results of operations and prospects.
We may need to obtain substantial additional financing to fund our operations and
expansion, and if we fail to do so, we may be unable to complete the development and
commercialization of our drug candidates.
During the Track Record Period, we financed our operations, including our research and
development activities in relation to our preclinical studies and clinical trials, primarily
through proceeds from our financing activities. We expect to fund our future operations
primarily with existing cash and cash equivalents, net proceeds from the Global Offering,
payments received from our license and collaboration agreements, including royalties from the
sales of GFH925 in Greater China, proceeds from commercial loans, and future sales of our
commercialized drug products. Changes in our ability to fund our operations may affect our
cash flow and results of operations. Although we are conducting this Global Offering, we may
nevertheless require substantial additional capital to meet our continued operating cash
requirements, especially to fund our research and development activities, commercialization of
our drug candidates and development of manufacturing capabilities. As our business continues
to expand, we may seek additional funding through equity offerings, debt financings, license
and collaboration arrangements and other sources, which may not be available on terms
favorable or commercially reasonable to us or at all.
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We face exposure to fair value change of financial assets at FVTPL and valuation
uncertainty due to the use of unobservable inputs.
For the years ended December 31, 2023 and 2024 and four months ended April 30, 2024
and 2025, we recorded fair value gains on financial assets measured at FVTPL of RMB3.6
million, RMB0.4 million, RMB0.2 million and nil, respectively. We did not have any financial
assets at FVTPL as of December 31, 2023 or 2024 or April 30, 2025, because our financial
assets at FVTPL reached maturity in 2023, and our financial assets at FVTPL purchased in
2024 reached maturity before December 31, 2024 and we did not make any purchases of such
financial assets in the first four months of 2025. After Listing, we may continue to purchase
low-risk wealth management products with a short maturity period based on our operational
needs. We therefore face exposure to fair value change of financial assets measured at FVTPL.
We cannot assure you that we can recognize comparable fair value gains in the future, and
we may on the contrary recognize fair value losses, which would affect our result of operations
for future periods. In addition, the valuation of financial assets at FVTPL is subject to
uncertainties due to the use of unobservable inputs. Such estimated fair values involve the
exercise of professional judgment and the use of certain bases, assumptions and unobservable
inputs, which, by their nature, are subjective and uncertain. As such, the valuation of financial
assets at FVTPL has been, and will continue to be, subject to uncertainties in estimations,
which may not reflect the actual fair value of these financial assets and result in fluctuations
in profit or loss from year to year.
Share-based payments may have a material and adverse effect on our financial
performance and cause shareholding dilution to our Shareholders.
We have granted share-based payments to, among others, attract and retain outstanding
individuals to serve the Company. We believe the granting of share-based payment is of
significant importance to our ability to attract and retain key personnel and employees, and we
may continue to grant share-based payment to employees in the future. For the years ended
December 31, 2023 and 2024 and four months ended April 30, 2024 and 2025, we incurred
equity-settled share-based payment expenses of RMB37.0 million, RMB26.9 million, RMB9.6
million and RMB8.8 million, respectively. See Note 29 of the Accountants’ Report set out in
Appendix I to this Prospectus. As a result, our expenses associated with share-based payment
may increase, which may have an adverse effect on our results of operations. We may
re-evaluate the vesting schedules, lock-up period, exercise price or other key terms applicable
to the grants under our currently effective share incentive plans and any subsequently adopted
share incentive plans from time to time. If we choose to do so, we may experience substantial
change in our share-based payment charges. In addition, such share-awards may dilute the
shareholding percentage of our existing Shareholders and could result in a decline in the value
of our H Shares.
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We are subject to credit risk arising from trade receivables.
As of December 31, 2023 and 2024 and April 30, 2025, we had trade receivables of
RMB72.4 million, RMB109.2 million and RMB97.5 million, respectively. We may be exposed
to credit risk with our counterparties and may not be able to collect all of such receivables due
to a variety of factors that are outside of our control. If the relationship between us and any
of our counterparties is terminated or deteriorated, or if our counterparties experience financial
or operational difficulties, the recoverability of our receives may be negatively affected, which
may have a material and adverse effect on our business, financial condition and results of
operations.
Certain of our subsidiaries currently enjoy, and other subsidiaries may in the future
enjoy, preferential tax treatment, including reduced tax rates. The expiration of, or
changes to, any of these preferential tax treatments could adversely affect our business,
financial condition, and results of operations.
We have received preferential tax treatments and currently benefit from certain
preferential tax treatments that reduce our overall tax obligations. These benefits include
reduced tax rates, tax refunds, or other favorable tax policies provided by governmental
authorities in certain jurisdictions where we operate. However, these preferential tax treatments
are typically subject to review and renewal by the relevant tax authorities and are dependent
on our compliance with applicable rules and regulations. There is no assurance that we will
continue to qualify for such preferential tax treatment or that these benefits will be renewed
upon expiration. In addition, changes to existing laws, regulations, or interpretations of tax
policies could result in the reduction or elimination of these benefits. Furthermore, some of the
government grants or preferential tax treatments are subject to the satisfaction of certain
conditions, including compliance with requirements of the applicable incentive programs. We
cannot guarantee that we have satisfied or will continue to satisfy all relevant conditions, and
if we fail to satisfy any such conditions, we may be deprived of the relevant incentives. Any
such change, non-renewal, or failure to qualify could significantly increase our tax obligations
and adversely affect our business, financial condition, and results of operations.
RISKS RELATING TO OUR OPERATIONS
We may encounter difficulties in managing our anticipated growth or expand our
operations successfully.
As we seek to advance our pipeline products through clinical trials and eventually achieve
commercialization, we will need to expand our development, regulatory, manufacturing, sales
and marketing capabilities or contract with third parties to provide these capabilities for us. In
addition, we may need to manage additional relationships with various strategic partners,
suppliers and other third parties. Future growth will impose significant additional
responsibilities on our management. Our future financial performance and our ability to
commercialize our pipeline products and to compete effectively will depend, in part, on our
ability to manage any future growth effectively. We cannot assure you that we will be able to
RISK FACTORS
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successfully develop and commercialize our drug candidates and build suitable, or procure for
external providers, manufacturing, sales, marketing and managerial functions to meet our
growth targets. Our inability to accomplish any of these tasks could prevent us from
successfully growing our company.
Managing our growth and executing our growth strategies will require, among other
things, our ability to continue to innovate and develop advanced technology in the highly
competitive global pharmaceutical market, effective coordination and integration of our teams
across different sites, successful hiring and training of personnel, effective cost control,
sufficient liquidity, effective and efficient financial and management control, increased sales
and marketing activities, effective quality control, and management of our suppliers and
collaborators. If we are not able to effectively manage our growth or execute our growth
strategies, our business, financial condition, results of operations and prospects could be
adversely affected.
We, our management and directors may be involved in claims, disputes, litigation,
arbitration or other legal proceedings in the ordinary course of business.
We, our management or directors may from time to time become party to litigation, legal
disputes, claims or administrative proceedings arising in the ordinary course of our business.
These may concern issues relating to, among others, product liability, environmental matters,
breach of contract, employment or labor disputes and intellectual property rights. For example,
we may be sued if our pipeline products cause or are perceived to cause injury or are found to
be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such
product liability claims may include allegations of defects in manufacturing, defects in design,
a failure to warn of dangers inherent in the drug, negligence, strict liability or a breach of
warranties.
Involvement in litigation, legal disputes, claims or administrative proceedings may
distract our management’s or directors’ attention and consume our time and other resources.
Furthermore, any litigation, legal disputes, claims or administrative proceedings which are
initially not of material importance may escalate due to the various factors involved, such as
the facts and circumstances of the cases, the likelihood of winning or losing, the monetary
amount at stake and the parties concerned, and such factors may result in these cases becoming
of material importance to us. If we cannot successfully defend ourselves against the claims, we
may incur substantial liabilities or be required to limit commercialization of our pipeline
products.
In addition, negative publicity arising from litigation, legal disputes, claims or
administrative proceedings may damage our reputation and adversely affect the image of our
brands and products. In addition, if any verdict or award is rendered against us, we could be
required to pay significant monetary damages, assume other liabilities, and suspend or
terminate the related business ventures or projects. Consequently, our business, financial
condition and results of operations may be materially and adversely affected.
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Our future success depends in part on our ability to retain key executives and to attract,
hire, retain and motivate other qualified and highly skilled personnel.
We depend on the continued contributions of our senior management, especially the
executive officers listed in the section headed “Directors, Supervisors and Senior
Management” in this Prospectus, and other key employees, many of whom may be difficult to
replace. Replacing executive officers, scientific employees, and other qualified personnel may
be difficult and may take an extended period of time because of the limited number of
individuals in our industry with the breadth of skills and experience required to successfully
develop, gain regulatory approval of and commercialize products like those we develop. The
loss of the services of any of our executive officers or other key employees could impede the
achievement of our research, development and commercialization objectives.
Our future success is dependent on our ability to attract qualified employees and retain
existing key employees, especially our drug development and technology professionals. We
believe that there is, and will continue to be, intense competition for highly skilled
management, technical, sales and other personnel with experience in our industry in the cities
where our offices are located. Our need to increase the number of our qualified employees and
retain key employees may cause us to materially increase compensation-related costs,
including stock-based compensation. We must provide competitive compensation packages and
a high-quality work environment to hire, retain and motivate employees. To the extent we hire
personnel from competitors, we also may be subject to allegations that they have been
improperly solicited or divulged proprietary or other confidential information. If we are unable
to retain and motivate our existing employees and attract qualified personnel for important
positions, we may be unable to manage our business effectively, including the development,
marketing and sale, which could adversely affect our business, operating results and financial
condition, and the price of our H Shares could suffer.
If we, our CROs, CDMOs or business partners fail to comply with environmental, health
and safety laws and regulations, we could be subject to fines or penalties and other
negative consequences that could have a material adverse effect on our business.
We are subject to numerous environmental, health and safety laws and regulations,
including those governing laboratory procedures and the handling, use, storage, treatment and
disposal of hazardous materials and wastes. Our operations may involve the use of hazardous
and flammable materials, including chemicals materials, and may produce hazardous wastes.
For additional information, see “Business — Environmental, Social and Governance.” We may
contract with third parties for the disposal of these materials and wastes. We cannot eliminate
the risk of contamination or injury from these materials and wastes, whether arising from our
own operations or those of our CROs, CDMOs or other business partners, now or in the future.
In the event of such contamination or injury, we could be held liable for any resulting damages,
and such liabilities could exceed our resources. We could also incur significant costs associated
with civil or criminal fines and penalties.
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In addition, we may incur substantial costs to ensure compliance with current or future
environmental, health and safety laws and regulations. These current or future laws and
regulations may affect our research, development or production efforts. Failure to comply with
these laws and regulations also may result in substantial fines, penalties or other sanctions that
could have a material adverse effect on our business.
Any failure to comply with applicable laws and regulations and industry standards or
obtain various licenses and permits could harm our reputation, business, financial
condition, results of operations and prospects.
A number of governmental agencies or industry regulatory bodies impose strict rules,
regulations and industry standards governing biopharmaceutical research and development
activities, which apply to us. Our or our collaborators’ failure to comply with such regulations
could result in the termination of ongoing research, administrative penalties imposed by
regulatory bodies or the disqualification of data for submission to regulatory authorities. This
could harm our reputation, business, financial condition, results of operations and prospects.
Pursuant to relevant laws and regulations, we are required to obtain, maintain and renew
various approvals, licenses, permits and certificates from relevant authorities to operate our
business. For additional information, see “Business — Permits, Licenses and Other
Approvals.” Any failure to obtain or renew any approvals, licenses, permits and certificates
necessary for our operations may result in enforcement actions including orders issued by the
relevant regulatory authorities to take remedial actions, suspend our operations or impose fines
and penalties which could materially and adversely affect our business, financial condition,
results of operations and prospects. If the interpretation or implementation of laws and
regulations is adjusted in the future or new regulations come into effect, or the criteria used in
reviewing applications for, or renewals of permits, licenses and certificates change to adapt to
new developments, we may be required to obtain any additional approvals, permits, licenses or
certificates and we cannot assure you that we will be able to do so. Our failure to obtain the
additional approvals, permits, licenses or certificates may restrict the conduct of our business,
increase our costs, and in turn, adversely affect results of operations and prospects.
Any government investigation of alleged violations of laws could require us to expend
significant time and resources in response and generate negative publicity. Any failure to
comply with ongoing regulatory requirements may significantly and adversely affect our
ability to commercialize and generate revenue from our products. If regulatory sanctions are
applied or if regulatory approval is withdrawn, the value of our H Shares and our results of
operations will be adversely affected.
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We have limited insurance coverage, and any claims beyond our insurance coverage may
result in our incurring substantial costs and a diversion of resources.
We maintain insurance policies that are required under the applicable laws and
regulations as well as based on our assessment of our operational needs and industry practice.
For more details, please see “Business — Insurance.” Although we maintain insurance
coverage for adverse events in our clinical trials, this coverage may prove to be inadequate or
could cease to be available to us on acceptable terms, if at all. A claim brought against us that
is uninsured or under-insured could harm our business, financial condition and results of
operations. Our insurance coverage may also be insufficient to cover any claim for product
liability, damage to our fixed assets or employee injuries. Any liability or damage to, or caused
by, our facilities or our personnel beyond our insurance coverage may result in our incurring
substantial costs and a diversion of resources.
Our information technology systems, or those used by our partners or other contractors
or consultants, may fail or suffer security breaches.
We make use of information technology systems to obtain, process, analyze and manage
data. We use these systems to, among other things, monitor the daily operations of our
business, record research and development activities, maintain operating and financial data, as
well as manage our quality control systems. Despite the implementation of security measures,
our information technology systems and those of our CROs, consultants and other service
providers are vulnerable to damage from computer viruses, unauthorized access, cyber-attacks,
natural disasters, terrorism, war and telecommunication and electrical failures. Any system
damage or failure that interrupts data input, retrieval or transmission or increases service time
could disrupt our normal operations. To the extent that any disruption or security breach were
to result in a loss of or damage to data or applications, or inappropriate disclosure of
confidential or proprietary information, we could incur liability and the further development of
our drug candidates could be delayed.
There can be no assurance that we will be able to effectively handle a failure of our
information systems, or that we will be able to restore our operational capacity in a timely
manner to avoid disrupting our business. The occurrence of any of these events could adversely
affect our ability to effectively manage our business operations. In addition, if the capacity of
our information systems fails to meet the increasing needs of our expanding operations, our
ability to expand may be constrained.
Negative publicity on us or failure to maintain and enhance our recognition and
reputation may materially and adversely affect our business.
We believe that market awareness and recognition of our brand image, and the
maintenance of a positive brand image, is crucial to the success of our business. While we will
continue to promote our brands to remain competitive, we may not be successful in doing so.
In addition, we may engage various third parties, such as contract sales organizations, to
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expand our commercialization network and increase market access for our drugs, which can
make it increasingly difficult to effectively manage our brand reputation, as we have relatively
limited control over these third parties.
Any negative publicity, including disputes concerning us, our business partners or our
affiliates, even if untrue, could adversely affect our reputation and prospects. Moreover, if we
are unable to maintain a good reputation, our ability to attract and retain key employees and
business partners could be harmed which, in turn, may materially and adversely affect our
business, financial condition, results of operations and prospects.
Our reputation is vulnerable to potential threats that can be difficult or impossible to
control, and costly or impossible to remediate. Negative publicity about us, such as alleged
misconduct or improper activities, or negative rumors relating to us, our management,
employees, business partners or affiliates, can harm our business, financial condition, results
of operations and prospects, even if they are unsubstantiated or are later satisfactorily
addressed. Any regulatory inquiries or investigations or other actions against our management,
any perceived unethical, fraudulent, or inappropriate business conduct by us or perceived
wrongdoing by any key member of our management team or other employees, our business
partners or our affiliates, could harm our reputation and materially and adversely affect our
business. Regardless of the merits or final outcome of such regulatory inquiries, investigations
or actions, our reputation may be substantially damaged, which may impede our ability to
attract and retain talent and business partners and grow our business.
Moreover, any negative media publicity about the pharmaceutical industry in general,
including issues and allegations solely involving other companies in the industry, may also
negatively impact our reputation. In the event that such negative publicity relates to our own
products and business, the adverse impact on our financial condition or results of operations
might be more significant. Any such negative publicity may undermine the public confidence
in our products, reputation, brand image, business prospects, and impair the development and
commercialization of our pipeline products, all of which may adversely affect our business
operations and financial performance. Investigations and increasingly stringent regulations
arising from such negative publicity, if any, may draw time and attention from our management
team, which would have otherwise been devoted into our business operations, or may incur
additional compliance expenses.
We may be subject to disasters, health epidemics, acts of war, terrorism, business
disruptions and other force majeure events, which may have a material adverse effect on
our business.
Natural disasters, acts of war, terrorism or other force majeure events beyond our control
may adversely affect the economy, infrastructure and livelihood of the people in the regions
where we conduct our business. Our operations, and those of our third-party collaborators,
suppliers and other contractors and consultants, may be under the threat of natural disasters
such as floods, earthquakes, sandstorms, snowstorms, fire or drought, the outbreak of a
widespread health epidemic, such as swine flu, avian influenza, severe acute respiratory
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syndrome, or SARS, Ebola, Zika, COVID-19, force majeure events such as power, water or
fuel shortages, failures, malfunction and breakdown of information management systems,
unexpected maintenance or technical problems, or potential wars or terrorist attacks.
The occurrence of a disaster or a prolonged outbreak of an epidemic illness or other
adverse public health developments could materially disrupt our business and operations. For
example, since the end of December 2019, the outbreaks of a novel strain of coronavirus
COVID-19 have materially and adversely affected the global economy. Many countries and
regions had been affected by the COVID-19 outbreaks. There is no assurance that such kind
of health epidemic or even a more severe pandemic will not occur again in the future.
There also could occur serious natural disasters, which may result in loss of lives, injury,
destruction of assets and disruption of our business and operations. Damage or extended
periods of interruption to our, our collaborators’ or our suppliers’ corporate, development,
research or manufacturing facilities due to fire, disaster, epidemics, power loss,
communications failure, unauthorized entry or other events could cause us to cease or delay
development or commercialization of some or all of our pipeline products. As we rely on third
parties on various services and supplies, the occurrence of any of the foregoing events could
seriously harm ability to obtain services or supplies if such third parties are affected by
disasters, epidemics, business interruptions and other force majeure events. In addition, our
insurance might not cover all losses under such circumstances and our business may be
seriously harmed by such delays and interruption.
Acts of war or terrorism may also injure our employees, disrupt our business network and
destroy our markets. In addition, in response to acts of war or conflicts, the United States, the
EU, the United Kingdom and other countries may impose certain economic sanctions and
export control restrictions against certain countries involved in such wars or conflicts, which
could restrict our business opportunities and impact our business. In addition, as monitoring
and ensuring compliance with such economic sanctions and export control restrictions can be
challenging, we may be subject to both civil and criminal penalties, including substantial fines,
possible incarceration of responsible individuals for willful violations, possible loss of our
export or import privileges and reputation harm, in case there are any failure to comply with
these regimes.
Any of the foregoing events and other events could have an adverse effect on the overall
business sentiment and environment, cause uncertainties in the regions where we conduct
business, cause our business to suffer in ways that we cannot predict and materially and
adversely impact our business, financial condition, results of operations and prospects.
We may be exposed to the risks of conducting business in multiple jurisdictions.
Overseas markets are an important component of our growth strategy. We are exploring
and plan to continue to explore market opportunities overseas, where we believe there is
substantial demand for our pipeline products, and we intend to continue to identify and
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collaborate with reputable local partners that have proven track record to maximize the global
value of our pipeline products. We will also continue seeking licensing and co-development
opportunities to expand our global clinical programs.
However, such activities may subject us to additional risks that may materially adversely
affect our ability to attain or sustain profitable operations, including but not limited to:
 efforts to enter into license and collaboration arrangements with third parties may
increase our expenses or divert our management’s attention from the development of
drug candidates;
 political and economic instability as well as geopolitical tensions, including the
threat of war or terrorist attacks (notably the Russia-Ukraine conflicts and the
reaction of the international community, the consequences of which on the financial
markets and the global business climate remain uncertain);
 differing regulatory requirements for drug approvals and marketing internationally;
 potentially longer payment cycles, greater difficulty in accounts receivable
collection and potentially adverse tax treatment;
 difficulty of effective enforcement of contractual provisions in local jurisdictions;
 unexpected changes in tariffs, trade barriers and regulatory requirements, and delays
resulting from difficulty in obtaining export licenses, tariffs and other barriers and
restrictions;
 significant adverse changes in currency exchange rates;
 compliance with tax, employment, immigration and labor laws for employees
traveling abroad;
 the effects of applicable foreign tax structures and potentially adverse tax
consequences; and
 business interruptions resulting from geo-political actions, including war and acts of
terrorism, or natural disasters, including earthquakes, volcanoes, typhoons, floods,
hurricanes and fires.
In addition, changes in international trade policies may also adversely affect various
aspects of our business operations. For example, the U.S. government has made statements and
taken certain actions that may lead to potential changes to U.S. and international trade policies
towards China. It remains unclear what additional actions, if any, will be taken by the U.S. or
other governments with respect to international trade agreements, the imposition of tariffs on
goods imported into the U.S., tax policy related to international commerce, or other trade
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matters. It is unknown whether new tariffs will be imposed, or whether new laws and
regulations will be enacted, or the effect that any such actions would have on us or our industry.
While we have not commenced commercial sales of drug candidates overseas markets, any
unfavorable government policies on international trade, such as capital controls or tariffs, may
affect the import or export of raw materials and disrupt our drug development and the
manufacturing of our drug candidates. Such unfavorable policies may also negatively impact
the hiring of scientists and other research and development personnel, the demand for and
competitiveness of our drugs, or prevent us from selling our drugs in certain countries.
On September 9, 2024, the U.S. House of Representatives passed the BIOSECURE Act.
The BIOSECURE Act prohibits entities that receive federal funds from using biotechnology
that is from a company associated with a foreign adversary. WuXi Biologics and WuXi
Apptech, which are our major suppliers, were named as “companies of concern” under the
BIOSECURE Act. However, the BIOSECURE Act was not included in the last legislation
during the 118 United States Congress and as a result, it did not become law in 2024. Because
the BIOSECURE Act has not been enacted, it would not have any material impact on our
business operations and financial conditions.
If any new tariffs, policies, legislation and/or regulations are announced or implemented,
or if existing trade agreements are renegotiated, such changes could have an adverse effect on
our business, financial condition, results of operations and prospects.
RISKS RELATING TO DOING BUSINESS IN JURISDICTIONS WHERE WE
OPERATE
We may be subject to the approval, filing or other requirements of the CSRC or other
PRC governmental authorities in connection with future capital raising activities, and, if
required, we cannot predict whether we will be able to obtain such approval or complete
such filing.
On July 6, 2021, the General Office of the State Council, together with another regulatory
authority, jointly promulgated the Opinions on Strictly Combating Illegal Securities Activities
in Accordance with the Law (จԈ), which calls for,
among others, enhanced administration and supervision of overseas-listed China-based
companies, proposes to revise the relevant regulation governing the overseas issuance and
listing of shares by such companies, and clarifies the responsibilities of competent domestic
industry regulators and government authorities.
On February 17, 2023, the CSRC released the Trial Administrative Measures of Overseas
Securities Offering and Listing by Domestic Companies ( ྤʫΆุྤ̮೯БᗇՎձɪ̹၍ଣ
) and certain supporting guidelines (together, “ Trial Measures ”), which came into
effect on March 31, 2023. Pursuant to the Trial Measures, domestic companies that seek to list
overseas, both directly and indirectly, should fulfill the filing procedure and report relevant
information to the CSRC. The filing is required to be conducted within three business days
after the submission of the application for initial public offering and listing overseas to the
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overseas regulators. The CSRC will review the filing application and may have queries and
may consult with other relevant regulators. Filings granted by the CSRC will have a valid term
of one year during which the issuer should complete the offering. Further follow-up offerings
after overseas listings also require a filing or a report submitted to the CSRC in accordance
with the Trial Measures, and the listed companies will need to report to the CSRC upon the
occurrence and public disclosure of certain significant matters such as a change in control,
penalty received from overseas securities regulators or relevant PRC regulators, a switch of
listing status and a termination of listing. There is uncertainty as to whether we will be able
to complete the filing procedures for this Listing in a timely manner or at all. If a domestic
company fails to complete the filing procedure or conceals any material fact or falsifies any
major content in its filing documents, such domestic company may be subject to administrative
penalties, such as orders to rectify, warnings, fines, and its controlling shareholders, actual
controllers, the person directly in charge and other directly liable persons may also be subject
to administrative penalties, such as warnings and fines.
Our PRC Legal Advisor is of the view that this Listing shall be deemed as a direct
overseas Listing by PRC domestic enterprise, and we are required to submit filings with the
CSRC within three business days after we submit filing to Hong Kong Stock Exchange for this
Listing. On June 25, 2025 the CSRC has issued a notification on our Company’s completion
of the PRC filing procedures necessary for the Listing of our H Shares on the Stock Exchange
and the Global Offering. We may also be subject to filing requirements with the CSRC under
the Trial Measures with respect to our future offerings, listings or any other capital raising
activities. We cannot assure you that we could meet such requirements or complete such filing
in accordance with the Trial Measures in a timely manner. Any failure may restrict our ability
to complete the Listing or any future equity capital-raising activities.
We are subject to privacy laws and information security policies related to data privacy
and security, and we may be exposed to risks relating to personal or other sensitive
information.
We are subject to privacy, data protection and information security laws and regulations
that apply to the collection, transmission, storage and use of personal information, which
among other things, impose certain requirements relating to the privacy, security and
transmission of personal information. The legislative and regulatory landscape for privacy, data
protection and information security continues to evolve in jurisdictions worldwide, and there
has been an increasing focus on these issues with the potential to affect our business. Failure
to comply with any of these laws and regulations could result in enforcement action against us,
fines, imprisonment of company officials and public censure, claims for damages by affected
individuals, damage to our reputation and loss of goodwill, any of which could have a material
adverse effect on our business, financial condition, results of operations or prospects. However,
our ongoing efforts to comply with evolving laws and regulations may be costly and require
ongoing modifications to our policies, procedures and systems.
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On December 28, 2021, the Cyberspace Administration of China (“ CAC”), jointly with
other 12 governmental authorities, promulgated the Measures for Cybersecurity Review ( ၣ
) (the “ MCR”), which became effective from February 15, 2022. Pursuant
to Article 2 of the MCR, if a critical information infrastructure operator purchases network
products and services or a network platform operator conducts any data processing activity that
affects or may affect national security, a cybersecurity review shall be carried out according to
the MCR. In accordance with Article 7 of the MCR, a network platform operator possessing
personal information of more than one million users must apply to the Cybersecurity Review
Office for cybersecurity review when listing abroad ( ਷̮ɪ̹).
As of the Latest Practicable Date, (i) we had not been notified of the results of any
determination that we have been identified as a critical information infrastructure operator by
the relevant governmental authorities; (ii) we had been focused on the discovery, development
and commercialization of therapeutics primarily for oncology, autoimmune and inflammatory
diseases, and had not conducted any business involving the collection, usage, storage or
processing of personal information of users through network information technology or via
internet; (iii) we had not received any notification of cybersecurity review from the relevant
governmental authorities, nor had we been involved in any investigations on cybersecurity
review initiated by CAC or received any inquiry, notice, warning, or sanctions in such respect;
and (iv) the Global Offering is a listing in Hong Kong, rather than a listing abroad ( ਷̮ɪ̹).
Therefore, as advised by our PRC Legal Advisor, taking into consideration the above and
provided that there is no material change to our current business and no further rules are
introduced and no significant changes to the MCR is made by the relevant governmental
authorities, our Directors believe cybersecurity review under the article 2 and article 7 of the
MCR shall not be applicable to us.
However, the MCR was released recently, certain provisions of which are subject to
clarification by the relevant governmental authorities. If we were deemed having conducted
any data processing activity that “affects or may affect national security” by the relevant
regulatory authorities, we may be subject to cybersecurity review under the MCR. If we fail
to pass such cybersecurity review, our Listing may be impeded, our business operations may
be adversely affected, and/or we may be subject to other penalties and/or actions by the
competent governmental authorities.
In addition, on September 24, 2024, the State Council released the Regulation on the
Administration of Cyber Data Security ( ၣഖᅰኽτΌ၍ଣૢԷ) (the “ Cyber Data
Security Regulation ”), which would come into effect on March 31, 2025. Cyber Data Security
Regulation stipulated certain requirements on data processors in their daily operations and,
among others, required an internet data processor to apply for a cybersecurity review pursuant
to relevant laws and regulations if such internet data processor processing activities that affect
or may affect national security. However, as the Cyber Data Security Regulation provided no
further explanation or interpretation for “affect or may affect national security,” there remains
uncertainty as to whether we would be subject to cybersecurity review under the Cyber Data
Security Regulation.
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On July 7, 2022, CAC promulgated the Measures for the Security Assessment of
Cross-border Data Transfer (), which took effect on September 1,
2022 and required that the data processors providing data overseas and falling under any of the
circumstances provided in Article 4 of the Measures for the Security Assessment of
Cross-border Data Transfer () shall apply for the security
assessment of cross-border data transfer. On March 22, 2024, CAC further promulgated the
Provisions on Facilitating and Regulating Cross-border Data Flow (ݴ
), providing the latest circumstances for the security assessment of cross-border data
transfer. According to the Provisions on Facilitating and Regulating Cross-border Data Flow
(), where a data processor transfers any data overseas and
has any of the following circumstances, it shall apply to the CAC for security assessment: (i)
where a data processor provides important data overseas; (ii) where a critical information
infrastructure operator or a data processor processing the personal information of more than 1
million individuals provides personal information; or (iii) where a data processor transfers
overseas the personal information of more than 100,000 individuals (excluding sensitive
personal information) or the sensitive personal information of more than 10,000 individuals on
a cumulative basis starting from January 1 of the said year. As of the Latest Practicable Date,
as our business operations had not fallen under any of the above-mentioned circumstances, our
Directors believed the security assessment of cross-border data transfer under the Measures for
the Security Assessment of Cross-border Data Transfer shall not be applicable to us currently.
Laws in all 50 U.S. states require businesses to provide notice under certain
circumstances generally to governmental authorities and affected individuals in connection
with certain breaches of personal information, and, in the future, we may be required to notify
applicable governmental authorities and affected individuals in the event of a data breach or
other data security incident. In addition to data breach notification laws, some states have
enacted statutes and rules requiring businesses to reasonably protect certain types of personal
information they hold or to otherwise comply with certain specified data security requirements
for personal information. Other states also have enacted laws and regulations relating to
privacy and information security and comprehensive privacy laws. The laws are not consistent,
as certain state laws may be more stringent or broader in scope, or offer greater individual
rights, with respect to sensitive and personal information than federal, international, or other
state laws, and such laws may differ from each other, which may complicate compliance
efforts. These laws may apply directly to our business or indirectly by contract when we enter
into collaboration arrangements to other companies. If we become subject to these new or
additional privacy laws, the risk of enforcement actions against us could increase.
In addition, the European Union’s General Data Protection Regulation (EU) 2016/679, or
GDPR, went into effect on May 25, 2018 in respect of processing operations carried out in the
context of the activities of an establishment in the European Economic Area, or EEA, and any
processing relating to the offering of goods or services to individuals in the EEA and/or the
monitoring of their behavior in the EEA. The GDPR provides that EEA member states may
make their own further laws and regulations to introduce specific requirements in certain areas,
including related to the processing of “special categories of personal data,” including personal
data related to health and genetic data. This may lead to greater divergence among the laws and
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regulations that apply to the processing of personal data across the EEA and United Kingdom,
compliance with which, as and where applicable, may increase our costs and could increase our
overall compliance risk. Such laws and regulations could also limit our ability to collect, use,
share and otherwise process personal data in the context of our EEA and/or UK establishments
(regardless of where any such processing occurs), and/or could cause our compliance costs to
increase, ultimately having an adverse impact on our business, and harming our business and
financial condition.
We may be restricted from transferring our scientific data abroad.
On March 17, 2018, the General Office of the State Council promulgated the Measures
for the Management of Scientific Data () (the “ Scientific Data
Measures ”), which provides a broad definition of scientific data and relevant rules for the
management of scientific data. According to the Scientific Data Measures, enterprises in China
must seek governmental approval before any scientific data involving a state secret may be
transferred abroad or to foreign parties. Further, any researcher conducting research funded at
least in part by the Chinese government is required to submit relevant scientific data for
management by the entity to which such researcher is affiliated before such data may be
published in any foreign academic journal. Given the term state secret is not clearly defined,
if and to the extent our research and development of drug candidates will be subject to the
Scientific Data Measures and any subsequent laws as required by the relevant government
authorities, we cannot assure you that we can always obtain relevant approvals for sending
scientific data (such as the results of our preclinical studies or clinical trials conducted within
China) abroad or to our foreign partners in China. If we are unable to obtain necessary
approvals in a timely manner, or at all, our research and development of drug candidates may
be hindered, which may materially and adversely affect our business, financial condition,
results of operations and prospects. If the relevant government authorities consider the
transmission of our scientific data to be in violation of the requirements under the Scientific
Data Measures, we may be subject to fines and other administrative penalties imposed by those
government authorities. In addition, according to the Administration of Human Genetic
Resources ( ɛᗳ፲ෂ༟๕၍ଣૢԷ) promulgated in March 2024 and the PRC Biosecurity
Law () promulgated in April 2024, if any scientific data falls within the scope
of Chinese human genetic resources, any transfer of such data outside of China will be subject
to the prior approval of the PRC Ministry of Science and Technology. There can be no
assurance that we will be able to obtain such approval in a timely manner, or at all.
The data collected by us mainly includes personal information of patients participating in
clinical trials and clinical trial data, and the relevant data are processed in accordance with the
informed consent forms agreed by the patients. To the best of our knowledge, we believe that
all the personal information of patients generated in our clinical trials has been de-identified
to the extent necessary. According to the cooperation agreements entered with our overseas
collaboration partners, we provide online access of certain clinical data to them.
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According to Article 22 of the Administration of the Management of Human Genetic
Resources, approval is not required where clinical institutions, in order to obtain the marketing
licenses of relevant drugs and medical devices in China, carry out international cooperation in
clinical trials by utilization of China’s human genetic resources by the clinical institutions but
not involving the export of physical materials of human genetic resources. However, the two
cooperating parties shall, before conducting such clinical trials, submit the types, quantities
and uses of the human genetic resources to be used to the health department of the State
Council for filing. We transfer clinical trial data to our collaboration partners online, which
does not involve the export of physical materials of human genetic resources, and have filed
with the Human Genetic Resource Administration of China certain reports regarding the use of
human genetic materials in clinical studies.
In addition, our transfer of the clinical trial data to our overseas collaboration partners
does not involve data export security assessment under the Measures for the Security
Assessment of Cross-Border Data Transmission, because we are not critical information
infrastructure operator, we do not process personal information of more than 1 million people,
and we do not provide personal information of more than 100,000 people or sensitive personal
information of more than 10,000 people to our overseas collaboration partners. With respect to
our cross-border transfer of clinical trial data, we have signed with our overseas collaboration
partner SELLAS the standard contract for the cross-border transfer of personal information.
We may be directly or indirectly subject to applicable anti-kickback, false claims laws,
doctor payment transparency laws, fraud and abuse laws or similar healthcare and
security laws and regulations, which could expose us to criminal sanctions, civil penalties,
contractual damages, reputational harm and diminished future earnings.
Healthcare providers and third-party payors play a primary role in the recommendation
and prescription of any drug candidates for which we obtain marketing approval. Our current
and future arrangements with healthcare professionals, clinical investigators, CROs, third-
party payors and customers may expose us to broadly applicable fraud and abuse and other
healthcare laws and regulations that may constrain the business or financial arrangements and
relationships through which our drug products, for which marketing approvals are obtained, are
marketed, sold and distributed.
For instance, the marketing and sales activities of GFH925 and our other pipeline
products, once they are approved by the NMPA, will be subject to various PRC fraud and abuse
laws, including the PRC Anti-Unfair Competition Law ()
and the PRC Criminal Law (). After receiving marketing approvals
from the FDA, our operations will be subject to federal and state fraud and abuse laws United
States, including the federal Anti-Kickback Statute and the False Claims Act, as well as
physician payment transparency laws and regulations, including the Physician Payments
Sunshine Act, among others.
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Furthermore, we are subject to anti-bribery laws in China and overseas that generally
prohibit companies and their intermediaries from making payments to government officials for
the purpose of obtaining or retaining business or securing other improper advantages. In
addition, although currently our business operations are primarily in China, we are subject to
the Foreign Corrupt Practices Act (FCPA) of the United States, which generally prohibits us
from making improper payments to non-U.S. officials for the purpose of obtaining or retaining
business. Failure to comply with anti-bribery laws could disrupt our business and lead to severe
criminal and civil penalties, including imprisonment, criminal and civil fines, loss of our
export licenses, suspension of our ability to do business with the government, denial of
government reimbursement for our products and/or exclusion from participation in government
healthcare programs.
Efforts to ensure that our business arrangements with third parties are in compliance with
applicable healthcare laws and regulations will involve substantial costs. Because of the
breadth of these laws and regulations, and the narrowness of the statutory exceptions and safe
harbors available, it is possible that some of our business activities could be subject to
challenge under one or more of such laws or regulations. Regulatory authorities could conclude
that our business practices may not comply with current or future fraud, abuse or other
healthcare laws or regulations. If any such actions are instituted against us, and if we are not
successful in defending ourselves or asserting our rights, those actions could result in the
imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary
fines, possible exclusion from participation in governmental healthcare programs, contractual
damages, reputational damage, diminished profits and future earnings, and curtailment of our
operations, any of which could adversely affect our ability to operate our business and have a
material adverse effect on our business, financial condition, results of operations and
prospects.
We are also exposed to the risk that our employees, independent contractors, consultants,
commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in
misconduct or other improper activities. In particular, sales, marketing and business
arrangements in the health care industry are subject to extensive laws and regulations intended
to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws
and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and
promotion, sales commission, customer incentive programs and other business arrangements.
Misconduct by these parties could also involve the improper use of information obtained in the
course of clinical trials, which could result in regulatory sanctions and serious harm to our
reputation. It is not always possible to identify and deter misconduct by these parties. Those
actions could have a significant impact on our business, including the imposition of significant
penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement,
imprisonment, exclusion from participation in government funded healthcare programs,
contractual damages, reputational harm, diminished profits and future earnings and the
curtailment or restructuring of our operations.
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There might be uncertainties in effecting service of legal process and enforcing foreign
judgments against us and our management in the PRC.
We are a company incorporated under the laws of the PRC, and a significant portion of
our assets and the majority of our Directors and senior management are located in the PRC. As
a result, it may be difficult for the investors to directly effect service of process outside the
PRC upon us or most of our Directors and senior management in the PRC.
On July 14, 2006, the Supreme People’s Court of the PRC and the government of the
Hong Kong Special Administrative Region entered into the Arrangement on Reciprocal
Recognition and Enforcement of Judgments in Civil and Commercial Matters by Courts of the
Mainland and the Hong Kong Special Administration Region Pursuant to Choice of Court
Agreements between Parties Concerned (ʝႩ̙ձੂБ຅
τર) (the “ Arrangement ”). Under the Arrangement,
where any designated PRC court or any designated Hong Kong court has made an enforceable
final judgment requiring payment of money in a civil or commercial case pursuant to a choice
of court agreement in writing, any party concerned may apply to the relevant PRC court or
Hong Kong court for recognition and enforcement of the judgment. A judgment rendered by a
Hong Kong court may not be enforced in Mainland China if the parties in dispute have not
agreed to enter into a choice of court agreement in writing.
On January 18, 2019, the Supreme People’s Court and the government of the Hong Kong
Special Administrative Region entered into the Arrangement on Reciprocal Recognition and
Enforcement of Judgments in Civil and Commercial Matters by the Courts of the Mainland and
of the Hong Kong Special Administrative Region (ʝႩ̙
τર) (the “ New Arrangement ”), which seeks to establish a
mechanism with further clarification on and certainty for reciprocal recognition and
enforcement of judgments in a wider range of civil and commercial matters between Mainland
China and Hong Kong. The New Arrangement does not include the requirements for a choice
of court agreement in writing by the parties. The New Arrangement has come into effect on
January 29, 2024 and superseded the Arrangement. After the New Arrangement became
effective, a judgment rendered by a Hong Kong court can generally be recognized and enforced
in the PRC even if the parties in the dispute do not enter into a choice of court agreement in
writing.
Required procedures on the remittance of Renminbi into and out of the PRC may affect
our ability to pay dividends and other obligations and affect the value of your investment.
Procedures on the remittance of Renminbi into and out of the PRC are required under the
relevant PRC laws and regulations. A substantial majority of our future revenue is expected to
be denominated in Renminbi and we will need to convert Renminbi into foreign currencies for
the payment of dividends, if any, to holders of our H Shares. Shortages in the availability of
foreign currency may affect our ability to remit sufficient foreign currency to pay dividends or
other payments, or otherwise satisfy our foreign currency denominated obligations.
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Under the relevant PRC laws and regulations, foreign exchange transactions under the
current account conducted by us do not require advance approval from China’s State
Administration of Foreign Exchange (“ SAFE ”), but we are required to present relevant
documentary evidence of such transactions and conduct such transactions at designated foreign
exchange banks within China that have the licenses to carry out foreign exchange business.
Approval from appropriate government authorities is required where Renminbi is to be
converted into foreign currency and remitted out of China to pay capital expenses such as the
repayment of loans denominated in foreign currencies.
Holders of H Shares may be subject to PRC income taxes.
Under the current PRC tax laws and regulations, non-PRC resident individuals and
non-PRC resident enterprises are subject to different tax obligations with respect to the
dividends paid to them by us and the gains realized upon the sale or other disposition of H
Shares.
Non-PRC resident individuals are required to pay PRC individual income tax at a 20%
rate for the income derived in China under the PRC Individual Income Tax Law (the “ IIT
Law”) and its implementation guidelines. Accordingly, we are required to withhold such tax
from dividend payments, unless applicable tax treaties between China and the jurisdiction in
which the foreign individual resides reduce or provide an exemption for the relevant tax
obligations. However, pursuant to the Circular on Certain Policy Questions Concerning
Individual Income Tax ()
(Cai Shui Zi [1994] No. 020) issued by the MOF and SA T on May 13, 1994, the income gained
by individual foreigners from dividends and bonuses of enterprises with foreign investment are
exempted from individual income tax for the time being. In addition, under the IIT Law and
its implementation regulations, non-PRC resident individual holders of H shares are subject to
individual income tax at a rate of 20% on gains realized upon the sale or other disposition of
H shares. However, pursuant to the Circular of Declaring that Individual Income Tax Continues
to be Exempted over Income of Individuals from the Transfer of Shares (ୃ
) (Cai Shui Zi [1998] No. 61) issued by the MOF and
the SA T on March 30, 1998, from January 1, 1997, the income of individuals from the transfer
of the shares of listed enterprises continues to be exempted from individual income tax.
As of the Latest Practicable Date, no aforesaid provisions had expressly provided that
individual income tax shall be levied on non-PRC resident individual holders on the transfer
of shares in PRC resident enterprises listed on overseas stock exchanges, and to our knowledge,
no such individual income tax was levied by PRC tax authorities in practice. However, there
is no assurance that the PRC tax authorities will not change these practices which could result
in levying income tax on non-PRC resident individual holders on gains from the sale of H
shares.
For non-PRC resident enterprises that do not have establishments or premises in China,
and for those that have establishments or premises in China but whose income is not related
to such establishments or premises, under the PRC Enterprise Income Tax Law and its
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implementation regulations, dividends paid by us and gains realized by such foreign enterprises
upon the sale or other disposition of H Shares are subject to PRC enterprise income tax at a
10% rate. In accordance with the Circular on Issues Relating to Withholding of Enterprise
Income Tax by PRC Resident Enterprises on Dividends Paid to Overseas Non-PRC Resident
Enterprise Shareholders of H Shares (͏ΆุΣྤ̮Hٰ
) (Guo Shui Han [2008] No. 897) issued by SA T on
November 6, 2008, the withholding tax rate for dividends payable to non-PRC resident
enterprise holders of H Shares will be 10% and we intend to withhold tax at a rate of 10% from
dividends paid to non-PRC resident enterprise holders of our H Shares (including HKSCC
Nominees). Non-PRC resident enterprises that are entitled to be taxed at a reduced rate under
an applicable income tax treaty or arrangement will be required to apply to the PRC tax
authorities for a refund of any amount withheld in excess of the applicable treaty rate, and
payment of such refund will be subject to the PRC tax authorities’ approval.
Despite the arrangements mentioned above, the interpretation and application of
applicable PRC tax laws and regulations by the competent tax authorities shall be in
accordance with the then effective laws and regulations, and new taxes may be imposed which
may materially and adversely affect the value of your investment in our H Shares.
We are subject to risks in relation to our social insurance and housing provident fund
contributions.
Pursuant to the Social Insurance Law of the PRC () and
the Regulations on the Administration of Housing Provident Funds (၍ଣૢ
Է), we are required to make contributions to the social insurance plans and the housing
provident fund under the relevant PRC laws and regulations for our employees.
As of April 30, 2025, we did not make full social security insurance contributions for
certain employees who are not PRC citizens, in accordance to their own preference, which we
estimate to be approximately RMB1.1 million during the Track Record Period. We also
engaged a third-party human resources agency to pay social insurance premium and housing
provident funds for one employee. Pursuant to the agreement entered into between such
third-party human resources agency and us, the third-party human resources agency would pay
social insurance premium and housing provident funds for such employee on behalf of us. As
of the Latest Practicable Date, (i) the employees had confirmed such arrangement and had
raised no objections in relation thereto; (ii) there had been no disputes between us, such
employees and/or the third-party human resources agency with regard to such arrangement, as
the case may be; and (iii) we had not received any notice of rectification from, or been imposed
any administrative penalty by, the relevant governmental authorities as a result of such
arrangement or nonpayment for employees who are not PRC citizens. If the relevant
governmental authorities determine the use of the third-party agency to pay social insurance
premium and housing provident funds to be non-compliant in the future or such human
resources agency fails to pay the social insurance premium or housing provident funds for our
employee as required by applicable PRC laws and regulations, or if the relevant government
authorities require us to pay social insurance premium for employees who are not PRC citizens
RISK FACTORS
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despite their own preference not having us make such payments, we may be subject to
additional contribution, late payment fee and/or penalties imposed by the relevant PRC
authorities for failing to discharge our obligations in relation to payment of social insurance
premium and housing provident funds as an employer or be ordered to rectify. This in turn may
adversely affect our financial condition and results of operations.
We are subject to risks associated with our leased properties.
We have leased certain properties in China as our offices and laboratories. Pursuant to the
Measures for Administration of Lease of Commodity Properties (),
which was promulgated by the Ministry of Housing and Urban-Rural Development of the PRC
(ண௅) on December 1, 2010 and became effective on February
1, 2011, both lessors and lessees are required to file the lease agreements for registration and
obtain property leasing filing certificates for their leases. As of the Latest Practicable Date, we
had not registered seven lease agreements as tenant, which were primarily used as offices and
laboratories. Although failure to register does not in itself invalidate the leases, we may be
subject to fines if we fail to rectify such non-compliance within the prescribed time frame after
receiving notice from the relevant PRC government authorities. The penalty ranges from
RMB1,000 to RMB10,000 for each unregistered lease, at the discretion of the relevant
authority. As of the Latest Practicable Date, we were not subject to any penalties arising from
the non-registration of lease agreements. However, we cannot assure you that we would not be
subject to any penalties and/or requests from local authorities to fulfill the registration
requirements, which may increase our costs in the future. In addition, as our leases expire, we
may face difficulties renewing them, either on commercially acceptable terms or at all. Our
inability to enter into new leases or renew existing leases on terms acceptable to us could
materially and adversely affect our business, results of operations or financial condition.
RISKS RELATING TO THE GLOBAL OFFERING
There has been no public market for our H Shares, and an active trading market for our
H Shares may not develop or be sustained.
Prior to the Global Offering, there was no public market for our H Shares. We cannot
assure you that a public market for our H Shares with adequate liquidity will develop and be
sustained following the completion of Global Offering. The Offer Price for our H Shares to the
public is the result of negotiations between us and the Sole Sponsor-Overall Coordinator (for
itself and on behalf of other Overall-Coordinators and the Underwriters), and the Offer Price
may differ significantly from the market price of the H Shares following the Global Offering.
We have applied to the Hong Kong Stock Exchange for the listing of, and permission to
deal in, the H Shares (including any H Shares which may be issued pursuant to the exercise of
the Offer Size Adjustment Option and the Over-allotment Option). A listing on the Hong Kong
Stock Exchange, however, does not guarantee that an active and liquid trading market for the
H Shares will develop, or if it does develop, that it will be sustained following the Global
Offering, or that the market price of the H Shares will not decline following the Global
RISK FACTORS
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Offering. If an active public market for our H Shares does not develop following the
completion of the Global Offering, the market price and liquidity of our H Shares could be
materially and adversely affected.
The price and trading volume of our H Shares may be volatile, which could lead to
substantial losses to investors.
The price and trading volume of our H Shares may be subject to significant volatility in
response to various factors beyond our control, including the general market conditions of the
securities in Hong Kong and elsewhere in the world. In particular, the business and
performance and the market price of the shares of other companies engaging in similar business
may affect the price and trading volume of our H Shares. In addition to market and industry
factors, the price and trading volume of our H Shares may be highly volatile for specific
business reasons, such as fluctuations in our revenue, earnings, cash flows, investments,
expenditures, regulatory developments, relationships with our suppliers, movements or
activities of key personnel, or actions taken by competitors. Moreover, shares of other
companies listed on the Hong Kong Stock Exchange with significant operations and assets in
China have experienced price volatility in the past, and it is possible that our H Shares may be
subject to changes in price not directly related to our performance but related to the overall
political and economic conditions in Hong Kong, the PRC or elsewhere in the world.
Our Single Largest Group of Shareholders have substantial influence over our Company
and their interests may not be aligned with the interests of our other Shareholders.
Immediately upon the completion of the Global Offering, without taking into account any
H Shares which may be issued pursuant to the exercise of the Offer Size Adjustment Option
or the Over-allotment Option, our Single Largest Group of Shareholders will collectively
control approximately 19.56% of the voting power at our general meetings. Our Single Largest
Group of Shareholders will thus have significant influence over our business and affairs,
including decisions in respect of mergers or other business combinations, acquisition or
disposition of assets, issuance of additional Shares or other equity securities, timing and
amount of dividend payments, and our management. This concentration of ownership may
discourage, delay or prevent a change in control of our Company, which could deprive other
Shareholders of an opportunity to receive a premium for their H Shares as part of a sale of our
Company and might reduce the price of our H Shares. These events may occur even if they are
opposed by our other Shareholders. In addition, the interests of our Single Largest Group of
Shareholders may differ from the interests of our other Shareholders. We cannot assure you that
our Single Largest Group of Shareholders will not exercise their substantial influence over us
and cause us to enter into transactions or take, or fail to take, actions or make decisions that
conflict with the best interests of our other Shareholders.
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Future sales or perceived sales or conversion of significant amounts of our H Shares in the
public market following the Global Offering could materially and adversely affect the
price of our H Shares.
The market price of our H Shares could decline as a result of future sales of a substantial
number of our H Shares or other securities relating to our H Shares in the public market, or the
issuance of new shares or other securities, or the perception that such sales or issuances may
occur. Future sales, or anticipated sales, of substantial amounts of our securities, including any
future offerings, could also materially and adversely affect our ability to raise capital at a
specific time and on terms favorable to us. In addition, our Shareholders may experience
dilution in their holdings if we issue more securities in the future. New shares or shares-linked
securities issued by us may also confer rights and privileges that take priority over those
conferred by the H Shares.
In addition, while investors subscribing shares in the Global Offering are not subject to
any restrictions on the disposal of the H Shares they subscribed (except otherwise disclosed in
this Prospectus), they may have existing arrangements or agreement to dispose part or all of
the H Shares they hold immediately or within certain period upon completion of the Global
Offering for legal and regulatory, business and market, or other reasons. Such disposal may
occur within a short period or any time or period after the Listing Date.
Any sale of the H Shares subscribed by such investors pursuant to such arrangement or
agreement could adversely affect the market price of our H Shares and any sizeable sale could
have a material and adverse effect on the market price of our H Shares and could cause
substantial volatility in the trading volume of our H Shares.
Y ou will incur immediate and significant dilution and may experience further dilution if
we issue additional Shares or equity securities in the future.
The Offer Price of the H Shares is higher than the net tangible asset value per H Share
immediately prior to the Global Offering. Therefore, purchasers of the H Shares in the Global
Offering will experience an immediate dilution. In order to expand our business, we may
consider offering and issuing additional Shares in the future. Purchasers of the H Shares may
experience dilution if we issue additional Shares in the future at a price which is lower than
the net tangible asset value per Share at that time. Furthermore, we may issue Shares through
the employee incentive platforms, which would further dilute Shareholders’ interests in our
Company.
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Payment of dividends is subject to restrictions under the PRC law and there is no
assurance whether and when we will pay dividends.
Under PRC law and the constitutional documents of our Company and our PRC operating
subsidiaries, dividends may be paid only out of distributable profits, which refer to after-tax
profits as determined under PRC GAAP less any recovery of accumulated losses and required
allocations to statutory capital reserve funds. Any distributable profits that are not distributed
in a given year are retained and become available for distribution in subsequent years. As a
result, our Company and our PRC operating subsidiaries may not be able to pay a dividend in
a given year if our Company or our PRC operating subsidiaries do not have distributable profits
as determined under PRC GAAP even if they have profits as determined under IFRS. During
the Track Record Period, no dividend had been paid or declared by us. See “Financial
Information — Dividends” for further details of our dividend policy.
There can be no assurance that future dividends will be declared or paid. The declaration,
payment and amount of any future dividends are subject to the discretion of our Directors, after
taking into account our results of operations, financial condition, cash requirements and
availability and other factors as they may deem relevant, and subject to the approval at
Shareholders’ meeting. We may not have sufficient or any profits to enable us to make dividend
distributions to our Shareholders in the future, even if our financial statements indicate that our
operations have been profitable.
Certain facts, forecasts and statistics in this Prospectus relating to the biopharmaceutical
industry are derived from various official government sources and have not been
independently verified by us.
Certain statistics, information and data contained in this Prospectus relating to China and
elsewhere in the world, and the industry in which we operate have been derived from various
official government publications. We believe that the sources of the information are
appropriate sources for such information, and we have taken reasonable care in extracting and
reproducing such information. However, information and statistics from official government
sources have not been independently verified by us or any other parties involved in the Global
Offering and no representation is given as to their accuracy. Due to possibly flawed or
ineffective collection methods and analysis or discrepancies between published information
and market practice, such statistics, information and data in this Prospectus may be inaccurate
or may not be comparable to statistics, information and data produced with respect to other
economies. Further, there is no assurance that they are stated or compiled on the same basis or
with the same degree of accuracy as the case may be in other jurisdictions. In all cases,
investors should give consideration as to how much weight or importance they should attach
to or place on such facts.
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Y ou should read the entire Prospectus carefully, and we strongly caution you not to place
any reliance on any information contained in press articles or other media regarding us
or the Global Offering.
Prior to the publication of this Prospectus, there has been coverage in the media regarding
us and the Global Offering, which contained among other things, certain financial information,
projections, valuations and other forward-looking information about us and the Global
Offering. We have not authorized the disclosure of any such information in the press or media
and do not accept any responsibility for the accuracy or completeness of such media coverage
or forward-looking statements. We make no representation as to the appropriateness, accuracy,
completeness or reliability of any information disseminated in the media. We disclaim any
information in the media to the extent that such information is inconsistent or conflicts with
the information contained in this Prospectus. Accordingly, prospective investors are cautioned
to make their investment decisions on the basis of the information contained in this Prospectus
only and should not rely on any other information.
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In preparation for the Listing, our Company has sought the following waivers from strict
compliance with the relevant provisions of the Listing Rules and exemption from strict
compliance with the Companies (Winding up and Miscellaneous Provisions) Ordinance.
W AIVER IN RESPECT OF MANAGEMENT PRESENCE IN HONG KONG
According to Rule 8.12 of the Listing Rules, a new applicant for a primary listing on the
Stock Exchange must have a sufficient management presence in Hong Kong. This normally
means that at least two of our executive Directors must be ordinarily resident in Hong Kong.
Rule 19A.15 of the Listing Rules further provides that the requirement in Rule 8.12 of the
Listing Rules may be waived by having regard to, among other considerations, our
arrangements for maintaining regular communication with the Hong Kong Stock Exchange.
We do not have a sufficient management presence in Hong Kong for the purpose of
satisfying the requirement under Rule 8.12 and Rule 19A.15 of the Listing Rules. Our
management headquarters, senior management, business operations and assets are primarily
based outside Hong Kong. The Directors consider that either by means of relocation of our
existing executive Directors or appointment of additional executive Directors who will be
ordinarily resident in Hong Kong would not be beneficial to, or appropriate for, our Group and
therefore would not be in the best interests of our Company or the Shareholders as a whole.
As such, we have applied to the Stock Exchange for, and the Stock Exchange has granted us
a waiver from strict compliance with Rule 8.12 and Rule 19A.15 of the Listing Rules. We will
ensure that there is a regular and effective communication between us and the Stock Exchange
by way of, among others, the following conditions:
(a) pursuant to Rule 3.05 of the Listing Rules, we have appointed Ms. Zhang and
Mr. NG Tung Ching Raphael (“ Mr. Ng ”) as our authorized representatives (the
“Authorized Representatives ”), who will act as our principal channel of
communication with the Stock Exchange and ensure that our Company complies
with the Listing Rules at all times. Mr. Ng is based in Hong Kong and our
Authorized Representatives will be available to meet with the Stock Exchange in
Hong Kong within a reasonable time frame upon the request of the Stock Exchange
and will be readily contactable by telephone and email to deal promptly with
enquiries from the Stock Exchange. Our Company has provided contact details of
the Authorized Representatives to the Stock Exchange and will inform the Stock
Exchange promptly in respect of any change in the Authorized Representatives;
(b) both Authorized Representatives have means to contact all Directors (including the
independent non-executive Directors) promptly at all times as and when the Stock
Exchange wishes to contact our Directors for any matters. Our Company has
implemented a policy whereby (1) each Director has provided their respective valid
phone numbers or other means of communication to the Authorized Representatives;
(2) in the event that a Director expects to travel or is otherwise out of office, he/she
will endeavor to provide his/her phone number of the place of his/her
accommodation to the Authorized Representatives or maintain an open line of
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communication via his/her mobile phone; and (3) each Director has provided his/her
mobile phone number, office phone number, e-mail address and, where available,
fax number to the Stock Exchange and will inform the Stock Exchange promptly if
there are any changes to the contact details of the Directors;
(c) pursuant to Rule 3.20 of the Listing Rules, each Director has provided his/her
contact information to the Stock Exchange and to the Authorized Representatives.
This will ensure that the Stock Exchange and the Authorized Representatives should
have means for contacting all Directors promptly at all times as and when required;
(d) all our Directors who are not ordinarily resident in Hong Kong have confirmed that
they possess or can apply for valid travel documents to visit Hong Kong and will be
able to meet with relevant members of the Stock Exchange in Hong Kong upon
reasonable notice, when required;
(e) pursuant to Rule 3A.19 of the Listing Rules, we have retained the services of Guotai
Junan Capital Limited as Compliance Advisor upon Listing for a period
commencing on the Listing Date and ending on the date on which we comply with
Rule 13.46 of the Listing Rules in respect of our financial results for the first full
financial year commencing after the Listing Date, which will act as an additional
channel of communication with the Stock Exchange and will be available to respond
to enquiries from the Stock Exchange. The contact details of the Compliance
Advisor have been provided to the Stock Exchange;
(f) our Authorized Representatives, Directors and other officers of our Company will
provide promptly such information and assistance as the Compliance Advisor may
reasonably require in connection with the performance of the Compliance Advisor’s
duties as set forth in Chapter 3A of the Listing Rules. There will be adequate and
efficient means of communication between our Company, Authorized
Representatives, Directors and other officers of our Company and the Compliance
Advisor, and to the extent reasonably practicable and legally permissible, we will
keep the Compliance Advisor informed of all communications and dealings between
the Stock Exchange and us; meetings between the Stock Exchange and our Directors
could be arranged through our Authorized Representatives or the Compliance
Advisor, or directly with our Directors within a reasonable time frame. We will
inform the Stock Exchange as soon as practicable in respect of any change of
Authorized Representatives and/or the Compliance Advisor; and
(g) we will appoint other professional advisors (including legal advisors in Hong Kong)
after the Listing to assist us in dealing with any questions which may be raised by
the Stock Exchange and to ensure that there will be prompt and effective
communication with the Stock Exchange.
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W AIVER IN RESPECT OF JOINT COMPANY SECRETARIES
Pursuant to Rules 3.28 and 8.17 of the Listing Rules and Chapter 3.10 of the Guide for
New Listing Applicants, a new applicant for listing on the Stock Exchange must appoint a
company secretary who, by virtue of his/her academic or professional qualifications or relevant
experience, is, in the opinion of the Stock Exchange, capable of discharging the functions of
the company secretary.
Note 1 to Rule 3.28 of the Listing Rules provides that the Stock Exchange considers the
following academic or professional qualifications to be acceptable:
(a) a member of The Hong Kong Chartered Governance Institute;
(b) a solicitor or barrister as defined in the Legal Practitioners Ordinance (Chapter 159
of the Laws of Hong Kong); and
(c) a certified public accountant as defined in the Professional Accountants Ordinance
(Chapter 50 of the Laws of Hong Kong).
Note 2 to Rule 3.28 of the Listing Rules further provides that the Stock Exchange
considers the following factors in assessing the “relevant experience” of the individual:
(a) length of employment with the issuer and other issuers and the roles he/she played;
(b) familiarity with the Listing Rules and other relevant laws and regulations including
the SFO, the Companies Ordinance, the Companies (Winding Up and Miscellaneous
Provisions) Ordinance and the Takeovers Code;
(c) relevant training taken and/or to be taken in addition to the minimum requirement
under Rule 3.29 of the Listing Rules; and
(d) professional qualifications in other jurisdictions.
Our Company has appointed Ms. Zhang and Mr. Ng as our joint company secretaries. See
“Directors, Supervisors and Senior Management — Joint Company Secretaries” for their
biographical details.
Ms. Zhang joined our Group in August 2017 and is our executive Director and secretary
to the Board. She has extensive experience in supervising financing and corporate governance
matters of our Company. The Company believes that it would be in the best interests of the
Company and the corporate governance of the Group to have a person such as Ms. Zhang as
its joint company secretary, who is our secretary to the Board and has day-to-day knowledge
of the Company’s affairs. Ms. Zhang has the necessary nexus to the Board and close working
relationship with management of the Company in order to perform the function of a joint
company secretary and to take the necessary actions in the most effective and efficient manner.
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However, Ms. Zhang presently does not possess any of the qualifications under Rules 3.28 and
8.17 of the Listing Rules, and may not be able to solely fulfill the requirements of the Listing
Rules. Therefore, we have appointed Mr. Ng, who is an Associate Member of both The Hong
Kong Chartered Governance Institute (the “ HKCGI ” formerly known as the Hong Kong
Institute of Chartered Secretaries) and The Chartered Governance Institute in the United
Kingdom. He also possesses the practitioner’s endorsement from HKCGI and fully meets the
requirements stipulated under Rules 3.28 and 8.17 of the Listing Rules, to act as the other joint
company secretary and to provide assistance to Ms. Zhang for an initial period of three years
from the Listing Date to enable Ms. Zhang to acquire the “relevant experience” under Note 2
to Rule 3.28 of the Listing Rules so as to fully comply with the requirements set forth under
Rules 3.28 and 8.17 of the Listing Rules.
Accordingly, we have applied to the Stock Exchange for, and the Stock Exchange
has granted, a waiver from strict compliance with the requirements under Rules 3.28 and 8.17
of the Listing Rules such that Ms. Zhang may be appointed as a joint company secretary of our
Company.
The waiver is valid for an initial period of three years from the Listing Date, and is
granted on the condition that Mr. Ng, as a joint company secretary of our Company, will work
closely with Ms. Zhang to jointly discharge the duties and responsibilities as company
secretaries and assist Ms. Zhang in acquiring the relevant experience as required under Rules
3.28 and 8.17 of the Listing Rules. Mr. Ng will also assist Ms. Zhang in organizing Board
meetings and Shareholders’ meetings of our Company as well as other matters of our Company
which are incidental to the duties of a company secretary. Mr. Ng is expected to work closely
with Ms. Zhang and will maintain regular contact with Ms. Zhang, the Directors and the senior
management of our Company. In addition, Ms. Zhang will comply with the annual professional
training requirement under Rule 3.29 of the Listing Rules and will enhance her knowledge of
the Listing Rules during the three-year period from the Listing. Ms. Zhang will also be assisted
by (a) the Compliance Advisor, particularly in relation to compliance with the Listing Rules;
and (b) the Hong Kong legal advisors of our Company, on matters concerning our Company’s
ongoing compliance with the Listing Rules and the applicable laws and regulations.
Pursuant to Chapter 3.10 of the Guide for New Listing Applicants, the waiver will be
revoked immediately if Mr. Ng ceases to provide assistance to Ms. Zhang as a joint company
secretary for the three-year period after the Listing Date or where there are material breaches
of the Listing Rules by our Company.
Prior to the expiration of the initial three-year period, the qualifications and experience
of Ms. Zhang will be re-evaluated to determine whether the requirements as stipulated in
Rules 3.28 and 8.17 of the Listing Rules can be satisfied and whether the need for ongoing
assistance will continue. We will demonstrate to and seek the confirmation from the Stock
Exchange that Ms. Zhang, having benefited from the assistance of Mr. Ng for the preceding
three years, has acquired the skills necessary to carry out the duties of company secretary and
the relevant experience within the meaning of Note 2 to Rule 3.28 of the Listing Rules so that
a further waiver will not be necessary.
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EXEMPTION FROM STRICT COMPLIANCE WITH SECTION 342(1)(b) OF THE
COMPANIES (WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE IN
RELATION TO PARAGRAPH 27 OF PART I AND PARAGRAPH 31 OF PART II OF
THE THIRD SCHEDULE TO THE COMPANIES (WINDING UP AND
MISCELLANEOUS PROVISIONS) ORDINANCE
Section 342(1)(b) of the Companies (Winding Up and Miscellaneous Provisions)
Ordinance requires all prospectuses to include matters specified in Part I of the Third Schedule
to the Companies (Winding Up and Miscellaneous Provisions) Ordinance (the “ Third
Schedule ”), and set out the reports specified in Part II of the Third Schedule.
Paragraph 27 of Part I of the Third Schedule requires a listing applicant to include in its
prospectus a statement as to the gross trading income or sales turnover (as the case may be)
of the company during each of the three financial years immediately preceding the issue of the
prospectus, including an explanation of the method used for the computation of such income
or turnover and a reasonable breakdown between the more important trading activities.
Paragraph 31 of Part II of the Third Schedule further requires a listing applicant to include
in its prospectus a report by the auditors of the company with respect to (i) the profits and
losses of the company for each of the three financial years immediately preceding the issue of
the prospectus and (ii) the assets and liabilities of the company of each of the three financial
years immediately preceding the issue of the prospectus.
Section 342A(1) of the Companies (Winding Up and Miscellaneous Provisions)
Ordinance provides that the SFC may issue, subject to such conditions (if any) as the SFC
thinks fit, a certificate of exemption from the compliance with the relevant requirements under
the Companies (Winding Up and Miscellaneous Provisions) Ordinance if, having regard to the
circumstances, the SFC considers that the exemption will not prejudice the interest of the
investing public and compliance with any or all of such requirements would be irrelevant or
unduly burdensome, or would otherwise be unnecessary or inappropriate.
Rule 4.04(1) of the Listing Rules requires that the consolidated results of the issuer and
its subsidiaries in respect of each of the three financial years immediately preceding the issue
of the listing document be included in the accountants’ report to the prospectus.
Our Company is a Biotech Company as defined under Chapter 18A of the Listing Rules
and is seeking a listing under Chapter 18A of the Listing Rules. Rule 18A.03(3) of the Listing
Rules requires that a Biotech Company must have been in operation in its current line of
business for at least two financial years prior to listing under substantially the same
management. Rule 18A.06 of the Listing Rules requires that a Biotech Company must comply
with Rule 4.04 of the Listing Rules modified so that references to “three financial years” or
“three years” in Rule 4.04 shall instead be references to “two financial years” or “two years,”
as the case may be. Further, pursuant to Rule 8.06 of the Listing Rules, the latest financial
period reported on by the reporting accountants for a new applicant must not have ended more
than six months from the date of the listing document.
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In compliance with the abovementioned requirements under the Listing Rules, the
Accountants’ Report set out in Appendix I is prepared to cover the two financial years ended
December 31, 2023 and 2024 and the four months ended April 30, 2025. As such, we have
applied to the SFC for, and the SFC has granted, a certificate of exemption from strict
compliance with section 342(1)(b) of the Companies (Winding Up and Miscellaneous
Provisions) Ordinance in relation to the requirements of paragraph 27 of Part I and paragraph
31 of Part II of the Third Schedule regarding the inclusion of the Accountants’ Report covering
the full three financial years immediately preceding the issue of this Prospectus on the
following grounds:
(a) our Company is primarily engaged in R&D and commercialization of biotech
products, and falls within the scope of Biotech Company as defined under Chapter
18A of the Listing Rules. Our Company will fulfill the additional conditions for
Listing required under Chapter 18A of the Listing Rules;
(b) the Accountants’ Report for the two financial years ended December 31, 2023 and
2024 and the four months ended April 30, 2025 has been disclosed in the prospectus
of our Company and is set out in Appendix I to this prospectus in accordance with
Rule 18A.06 of the Listing Rules;
(c) notwithstanding that the financial results set out in this Prospectus are only for the
two financial years ended December 31, 2023 and 2024 and the four months ended
April 30, 2025 in accordance with Chapter 18A of the Listing Rules, other
information required to be disclosed under the Listing Rules and the Companies
(Winding Up and Miscellaneous Provisions) Ordinance has been adequately
disclosed in this Prospectus pursuant to the relevant requirements;
(d) furthermore, as Chapter 18A of the Listing Rules provides track record period of two
years for biotech companies in terms of financial disclosure, strict compliance with
the requirements of section 342(1)(b) of the Companies (Winding Up and
Miscellaneous Provisions) Ordinance in relation to paragraph 27 of Part I and
paragraph 31 of Part II of the Third Schedule to the Companies (Winding Up and
Miscellaneous Provisions) Ordinance would be unnecessary and/or irrelevant in the
circumstance of the Company. Substantially all of our revenue in 2023 and 2024 was
derived from our collaboration with Innovent relating to our Core Product GFH925.
In contrast, the majority of our 2022 revenue came from our collaboration with
SELLAS regarding GFH009, which commenced in March 2022. As we continue to
monitor evolving treatment paradigms in hematological malignancies and assess the
broader landscape for CDK9 inhibitors, we may consider future development or
business development pathways to maximize the value of GFH009. However, we do
not anticipate generating any meaningful revenue from our collaboration with
SELLAS in the near term. Given the non-recurring nature of the revenue in 2022 and
its limited relevance to our current business operations and revenue model, we
believe the financial information in 2022 do not provide meaningful insight into our
ongoing performance and are not necessary for investors’ understanding and
assessment of the business, assets and liabilities, financial position, management
and prospects of the Group; and
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(e) the Accountants’ Report covering the two financial years ended December 31, 2023
and 2024 and the four months ended April 30, 2025 (as set out in Appendix I),
together with other disclosure in this Prospectus, have already provided the potential
investors with adequate and reasonably up-to-date information in the circumstances
to form a view on the track record of our Company; and our Directors confirm that
all information which is necessary for the investing public to make an informed
assessment of the business, assets and liabilities, financial position, management
and prospects has been included in this Prospectus. Therefore, the exemption would
not prejudice the interests of the investing public.
The SFC has granted us a certificate of exemption under section 342A of the Companies
(Winding Up and Miscellaneous Provisions) Ordinance exempting our Company from strict
compliance with section 342(1)(b) in relation to paragraph 27 of Part I and paragraph 31 of Part
II of the Third Schedule on the condition that particulars of the exemption are set out in this
Prospectus and that this Prospectus will be issued on or before September 11, 2025.
CONSENT IN RESPECT OF CORNERSTONE INVESTMENT BY CONNECTED
CLIENT
Paragraph 1C(1) of Appendix F1 to the Listing Rules provides that no allocations will be
permitted to “connected clients” of the overall coordinator(s), any syndicate member(s) (other
than the overall coordinator(s)) or any distributor(s) (other than syndicate member(s)), without
the prior written consent of the Stock Exchange.
Chapter 4.15 of the Guide for New Listing Applicants provides that the Stock Exchange
will ordinarily give its consent for allocation to connected clients if it is satisfied that: (i) the
allocation to a connected client represents genuine demand for securities of an applicant; and
(ii) the connected client has not taken and will not take advantage of its position to receive an
allocation for its own benefit at the expense of other placees or the public (i.e., no actual or
perceived preferential treatment has been given to such connected client).
We have applied to the Stock Exchange for a written consent under paragraph 1C(1) of
Appendix F1 to the Listing Rules to allow CITIC Securities International Capital Management
Limited (the “ CSICM ”) to subscribe for Offer Shares as a cornerstone investor. CLSA Limited
is the Sole Sponsor-Overall Coordinator and one of the distributors in respect of the Global
Offering. CSICM is a member of the same group of companies as CLSA Limited and is
considered as a connected client of CLSA Limited pursuant to paragraph 1B of Appendix F1
to the Listing Rules. CSICM will hold the Shares subscribed through the cornerstone
investment on behalf of independent third parties on a non-discretionary basis. The Stock
Exchange has granted the requested written consent on the following basis and conditions, as
set out in paragraph 6 of Chapter 4.15 of the Guide for New Listing Applicants, that:
(a) any Offer Shares to be allocated to CSICM will be held on non-discretionary basis
and on behalf of independent third parties;
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(b) the cornerstone investment agreement of CSICM does not contain any material
terms which are more favorable to it than those in other cornerstone investment
agreements;
(c) no preferential treatment has been, nor will be, given to CSICM by virtue of its
relationship with CLSA Limited, in any allocation of Offer Shares in the
International Offering other than the assured entitlement under the relevant
cornerstone investment agreement following the principles set out in Chapter 4.15
of the Guide for New Listing Applicants;
(d) CSICM confirms that it has not received and will not receive any preferential
treatment in the Global Offering allocation as a cornerstone investor by virtue of its
relationship with CLSA Limited, other than the preferential treatment of assured
entitlement under the cornerstone investment;
(e) each of the Company, the Overall Coordinators (including CLSA Limited as the Sole
Sponsor-Overall Coordinator) and CSICM has provided the Stock Exchange with
written confirmations in accordance with Chapter 4.15 of the Guide for New Listing
Applicants; and
(f) identities of the CSICM Ultimate Clients (Tibet Longrising) (as defined under the
section headed “Cornerstone Investors”) and details of the OTC Swaps (as defined
under the section headed “Cornerstone Investors”) are disclosed in this Prospectus,
and details of the cornerstone investment and the allocations are disclosed in this
Prospectus and will be disclosed in the allotment results announcement.
For further information about the proposed cornerstone investments by CSICM, please
refer to the section headed “Cornerstone Investors” in this Prospectus.
CONSENT IN RESPECT OF CORNERSTONE INVESTMENT BY CLOSE
ASSOCIATES OF MINORITY EXISTING SHAREHOLDER
Paragraph 1C(2) of Appendix F1 to the Listing Rules provides that no allocations will be
permitted to directors or existing shareholders of the applicant or their close associates,
whether in their own names or through nominees unless the conditions set out in Rules 10.03
and 10.04 of the Listing Rules are fulfilled, without the prior written consent of the Stock
Exchange.
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Paragraph 18 of Chapter 2.3 of the Guide for New Listing Applicants provides that the
Exchange permits an existing shareholder and/or its close associates to participate in the initial
public offering of a Biotech Company (as defined under Chapter 18A the Listing Rules)
provided that the applicant, in case of a PRC issuer, complies with Rules 19A.13A and
19A.13C of the Listing Rules in relation to the shares held by the public. Further, pursuant to
paragraph 18 of Chapter 2.3 of the Guide for New Listing Applicants, an existing shareholder
must subscribe for shares in the initial public offering as a cornerstone investor if it holds 10%
or more of the shares in the applicant prior to the initial public offering, and an existing
shareholder holding less than 10% of shares in the applicant prior to the initial public offering
may subscribe either as a cornerstone investor or placee.
Rule 19A.13A of the Listing Rules requires that, where a new applicant is a PRC issuer
with no other listed shares at the time of listing, at least a minimum prescribed percentage of
shares in the class to which H shares belong must be H shares held by the public at the time
of listing, determined by reference to the expected market value of the class of shares to which
H shares belong at the time of listing.
Rule 19A.13C of the Listing Rules further requires that, where a new applicant is a PRC
issuer with no other listed shares at the time of listing, the portion of H shares for which listing
is sought that are held by the public and not subject to any disposal restrictions (whether under
contract, the Listing Rules, applicable laws or otherwise), at the time of listing, must: (a)
represent at least 10% of the total number of issued shares in the class to which H shares belong
at the time of listing (excluding treasury shares), with an expected market value at the time of
listing of not less than HK$50,000,000; or (b) have an expected market value at the time of
listing of not less than HK$600,000,000.
Our Company has applied for a written consent under paragraph 5(2) of the Placing
Guidelines, to allow the following close associates of one of our existing Shareholder to
participate as cornerstone investors in the Global Offering:
(a) each of Lake Bleu Prime Healthcare Master Fund Limited, Lake Bleu Innovation
Healthcare Master Fund Limited, and LBC HK Opportunity Fund Limited
(collectively, the “ Lake Bleu Entities ”) is a Cornerstone Investor. LBC Sunshine
Healthcare Fund II L.P . (the “ Minority Existing Shareholder ”) is an existing
Shareholder of the Company. Each of the Lake Bleu Entities and the Minority
Existing Shareholder, is an investment fund managed by Lake Bleu Capital ( ૶ϫ༟
͉). Accordingly, each of the Lake Bleu Entities is a close associate of the Minority
Existing Shareholder.
For further details, please refer to the section headed “Cornerstone Investors” in this
prospectus.
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The Stock Exchange has granted the requested written consent subject to the conditions
that:
(a) the Company will comply with the public float requirement under Rule 19A.13A of
the Listing Rules and the free float requirement under Rule 19A.13C of the Listing
Rules;
(b) the Shares to be subscribed by and allocated to the Lake Bleu Entities under the
Global Offering will be at the same Offer Price and on substantially the same terms,
or no more favorable than, the terms of the other cornerstone investors (including
being subject to a lock-up period of six months from the Listing Date) and each of
the Lake Bleu Entities shall pay and settle in full the consideration for the relevant
Offer Shares before dealings commence on the Listing Date;
(c) no preference in allocation has been, nor will be, given to the Lake Bleu Entities by
virtue of their relationship with the Company other than the preferential treatment
of assured entitlement at the Offer Price under a cornerstone investment and the
terms of the cornerstone investment agreement of the Lake Bleu Entities are
substantially the same as the other cornerstone investment agreements following the
principles set out in Chapters 2.3 and 4.15 of the Guide for New Listing Applicants;
(d) each of the Company and the Sole Sponsor has provided the Stock Exchange with
written confirmations in accordance with Chapters 2.3 and 4.15 of the Guide for
New Listing Applicants; and
(e) the relevant information in respect of the allocation to the Lake Blue Entities as
Cornerstone Investors are disclosed in this Prospectus and will be disclosed in the
allotment results announcement.
For further information about the proposed cornerstone investments by the Lake Bleu
Entities, please refer to the section headed “Cornerstone Investors” in this Prospectus.
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DIRECTORS’ RESPONSIBILITY FOR THE CONTENTS OF THIS PROSPECTUS
This Prospectus, for which our Directors (including any proposed director who is named
as such in this Prospectus) collectively and individually accept full responsibility, includes
particulars given in compliance with the Companies (Winding up and Miscellaneous
Provisions) Ordinance, the Securities and Futures (Stock Market Listing) Rules (Chapter 571V
of the Laws of Hong Kong) and the Listing Rules for the purpose of giving information to the
public with regard to us. Our Directors, having made all reasonable enquiries, confirm that, to
the best of their knowledge and belief, the information contained in this Prospectus is accurate
and complete in all material respects and not misleading or deceptive, and there are no other
facts, the omission of which would make this Prospectus or any statement in this Prospectus
misleading.
CSRC FILING REQUIREMENT
On June 25, 2025, the CSRC has issued a notification on our Company’ completion of the
PRC filing procedures for the Listing of our H Shares on the Stock Exchange and the Global
Offering. As advised by our PRC Legal Advisor, our Company has completed all necessary
filings with the CSRC in the PRC in relation to the Global Offering and the Listing.
UNDERWRITING
This Prospectus is published solely in connection with the Hong Kong Public Offering
which forms part of the Global Offering. For applicants under the Hong Kong Public Offering,
this Prospectus contain the terms and conditions of the Hong Kong Public Offering. The Global
Offering comprises the Hong Kong Public Offering of initially 7,760,000 H Shares and the
International Offering of initially 69,840,000 H Shares (taking into account the Share
Subdivision, and subject, in each case, to reallocation on the basis described in “Structure of
the Global Offering” and, in case of the International Offering, any exercise of the Offer Size
Adjustment Option and the Over-allotment Option).
The listing of the Offer Shares on the Hong Kong Stock Exchange is sponsored by the
Sole Sponsor. Pursuant to the Hong Kong Underwriting Agreement, the Hong Kong Public
Offering is underwritten by the Hong Kong Underwriters on a conditional basis. The
International Offering is managed by the Sole Sponsor-Overall Coordinator and is underwritten
by the International Underwriters. The International Underwriting Agreement is expected to be
entered into on or about September 17, 2025. See “Underwriting” for details about the
Underwriters and the underwriting arrangements.
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RESTRICTIONS ON OFFER AND SALE OF THE OFFER SHARES
No action has been taken to permit a Hong Kong Public Offering of the Offer Shares or
the general distribution of this Prospectus in any jurisdiction other than Hong Kong.
Accordingly, this Prospectus may not be used for the purposes of, and does not constitute, an
offer or invitation in any jurisdiction or in any circumstances in which such an offer or
invitation is not authorized or to any person to whom it is unlawful to make such an offer or
invitation. The distribution of this Prospectus and the offering and sales of the Offer Shares in
other jurisdictions are subject to restrictions and may not be made except as permitted under
the applicable securities laws of such jurisdictions pursuant to registration with or
authorization by the relevant securities regulatory authorities or an exemption therefrom. Each
person acquiring the Hong Kong Offer Shares under the Hong Kong Public Offering will be
required to confirm, or be deemed by his or her acquisition of Hong Kong Offer Shares to
confirm, that he or she is aware of the restrictions on offers and sales of the Offer Shares
described in this Prospectus. In particular, the Offer Shares have not been offered or sold, and
will not be offered or sold, directly or indirectly, in the PRC.
The Offer Shares are offered for subscription solely on the basis of the information
contained and representations made in this Prospectus, and on the terms and subject to the
conditions set out herein and therein. No person is authorized in connection with the Global
Offering to give any information, or to make any representation not contained in this
Prospectus, and any information or representation not contained in this Prospectus must not be
relied upon as having been authorized by the Company, the Sole Sponsor, the Sole
Sponsor-Overall Coordinator, the Overall Coordinators, the Joint Global Coordinators, the
Joint Bookrunners, the Joint Lead Managers, the Capital Market Intermediaries, the
Underwriters, any of their respective directors, officers, employees, agents, affiliates or
advisors or any other persons or parties involved in the Global Offering. For further details of
the structure of the Global Offering, including its conditions, and the procedures for applying
for Hong Kong Offer Shares, see “Structure of the Global Offering” and “How to Apply for
Hong Kong Offer Shares.”
APPLICATION FOR LISTING ON THE HONG KONG STOCK EXCHANGE
We have applied to the Listing Committee for the granting of Listing of, and permission
to deal in, our H Shares to be issued pursuant to the Global Offering (including any H Shares
which may be issued pursuant to the Offer Size Adjustment Option and the Over-allotment
Option) under Chapter 18A of the Listing Rules. Dealings in the H Shares on the Hong Kong
Stock Exchange are expected to commence on Friday, September 19, 2025. No part of our
H Shares is listed on or dealt in on any other stock exchange, and no such listing or permission
to list is being or proposed to be sought as of the date of this Prospectus.
The H Shares will be traded in board lot of 200 H Shares. The stock code of the H Shares
is 2595.
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Under section 44B(1) of the Companies (Winding Up and Miscellaneous Provisions)
Ordinance, any allotments made in respect of any applications will be invalid if the listing of,
and permission to deal in, the Offer Shares on the Hong Kong Stock Exchange is refused before
the expiration of three weeks from the date of the closing of the application lists, or such longer
period (not exceeding six weeks) as may, within the said three weeks, be notified to the
Company by the Hong Kong Stock Exchange.
COMPLIANCE WITH LISTING RULES
We will comply with applicable laws and regulations in Hong Kong (including the Listing
Rules) and any other undertakings which have been given in favor of the Hong Kong Stock
Exchange from time to time. If the Listing Committee finds that there has been a breach by us
of the Listing Rules or such other undertakings which may have been given by us in favor of
the Hong Kong Stock Exchange from time to time, the Listing Committee may instigate
cancelation or disciplinary proceedings in accordance with the Listing Rules.
H SHARE REGISTER AND STAMP DUTY
All H Shares issued pursuant to applications made in the Hong Kong Public Offering and
the International Offering will be registered on the Company’s H Share register of members to
be maintained by our H Share Registrar, Computershare Hong Kong Investor Services Limited,
in Hong Kong. Our principal register of members will be maintained by us at our headquarters
in the PRC.
Dealings in the H Shares registered in our H Share register will be subject to Hong Kong
stamp duty. Hong Kong stamp duty is charged to each of the seller and purchaser at the ad
valorem rate of 0.1% on the higher of the consideration for or the market value of the H Shares
transferred. In other words, a total of 0.2% will be payable on a typical sale and purchase
transaction of the H Shares. In addition, a fixed stamp duty of HK$5.00 is currently payable
on each instrument of transfer of H Shares.
Unless determined otherwise by our Company, dividends payable in Hong Kong dollars
in respect of the H Shares will be paid to the Shareholders as recorded on the H Share register
of members of our Company in Hong Kong and sent by ordinary post, at the Shareholders’ risk,
to the registered address of each Shareholder.
H SHARES WILL BE ELIGIBLE FOR ADMISSION INTO CCASS
Subject to the granting of listing of, and permission to deal in, our H Shares on the Hong
Kong Stock Exchange and our compliance with the stock admission requirements of HKSCC,
our H Shares will be accepted as eligible securities by HKSCC for deposit, clearance and
settlement in CCASS with effect from the date of commencement of dealings in our H Shares
on the Hong Kong Stock Exchange or any other date as HKSCC chooses. Settlement of any
transactions between participants of the Hong Kong Stock Exchange is required to take place
in CCASS on the second settlement day after any trading day. All activities under CCASS are
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subject to the General Rules of HKSCC and the HKSCC Operational Procedures in effect from
time to time. All necessary arrangements have been made for our H Shares to be admitted into
CCASS. Investors should seek the advice of their stockbroker or other professional advisors for
details of the settlement arrangements as such arrangements may affect their rights and
interests.
PROFESSIONAL TAX ADVICE RECOMMENDED
Applicants for the Offer Shares are recommended to consult their professional advisors
if they are in any doubt as to the tax implications of subscribing for, purchasing, holding,
disposing of and dealing in our H Shares or exercising rights attached to them. None of the
Company, the Underwriters, the Sole Sponsor, the Sole Sponsor-Overall Coordinator, the
Overall Coordinators, the Joint Global Coordinators, the Joint Bookrunners, the Joint Lead
Managers, the Capital Market Intermediaries, the Underwriters, any of their respective
directors, supervisors, officers, employees, agents or advisors or any other persons involved in
the Global Offering accepts responsibility for any tax effects or liabilities of holders of Shares
resulting from the subscription, purchase, holding or disposal of, or dealing in, our H Shares.
OFFER SIZE ADJUSTMENT OPTION, OVER-ALLOTMENT OPTION AND
STABILIZATION
Assuming that the Offer Size Adjustment Option and the Over-allotment Option are both
exercised in full, our Company may be required to issue up to an aggregate of 25,026,000
additional H Shares. Details of the arrangements relating to the Offer Size Adjustment Option,
the Over-allotment Option, and stabilization are set out in “Structure of the Global Offering”
in this prospectus.
INFORMATION ON THE CONVERSION OF UNLISTED SHARES INTO H SHARES
Our Company has applied for conversion of Unlisted Shares into H Shares, which
involves 235,403,020 Unlisted Shares (taking into account the Share Subdivision) held by the
existing Shareholders. See “History, Development and Corporate Structure” and “Share
Capital” for details of our existing Shareholders and their respective interests in our Company
and relevant procedures for the conversion of Unlisted Shares into H Shares. Such H Shares
to be converted from Unlisted Shares are restricted from trading for a period of one year after
the Listing.
The relevant filing procedure in relation to the conversion of Unlisted Shares into H
Shares has been completed on June 25, 2025.
PROCEDURES FOR APPLICATION FOR HONG KONG OFFER SHARES
The procedures for applying for the Hong Kong Offer Shares are set out in “How to Apply
for Hong Kong Offer Shares.”
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STRUCTURE OF THE GLOBAL OFFERING
See “Structure of the Global Offering” for details of the structure of the Global Offering,
including its conditions.
LANGUAGE
The English names of the PRC nationals, entities, departments, facilities, certificates,
titles, laws, regulations and the like are translations of their Chinese names and are included
herein for identification purposes only. If there is any inconsistency, the Chinese name prevails.
ROUNDING
Certain amounts and percentage figures included in this Prospectus have been subject to
rounding adjustments, or have been rounded to one decimal place. Any discrepancies in any
tables or charts between the total shown and the sums of the amounts listed are due to rounding.
MARKET SHARE DATA
The statistical and market share information contained in this Prospectus has been derived
from official government publications, market data providers and other independent third-party
sources. Unless otherwise indicated, the information has not been verified by us independently.
This statistical information may not be consistent with other statistical information from other
sources within or outside the PRC. While reasonable caution has been made in the process of
reproducing the data and statistics extracted from such official government publications or
other sources, the Sole Sponsor and our Company, or any of their directors, employees, agents,
and representatives make no representation to the appropriateness, accuracy, completeness or
reliability of any such statistical and market share information.
CURRENCY TRANSLATIONS
Solely for your convenience, this Prospectus contains translations among certain amounts
denominated in Renminbi, Hong Kong dollars and U.S. dollars at specified rates.
Unless otherwise specified, the translation of Renminbi into Hong Kong dollars, of
Renminbi into U.S. dollars and of Hong Kong dollars into U.S. dollars, and vice versa, in this
Prospectus was made at the following rates:
RMB0.91183 to HK$1.00
RMB7.10890 to US$1.00
HK$7.79630 to US$1.00
No representation is made that any amounts in Renminbi, Hong Kong dollars or U.S.
dollars can be or could have been at the relevant dates converted at the above rates or any other
rates or at all.
INFORMATION ABOUT THIS PROSPECTUS AND THE GLOBAL OFFERING
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--- page 152 ---
DIRECTORS
Name Address Nationality
Executive Directors
Dr. Qiang LU No. 21, Lane 2466
Jinxiu Road
Pudong New Area
Shanghai
PRC
American
Dr. Jiong LAN No. 1, Lane 408
Qingtong Road
Pudong New Area
Shanghai
PRC
American
Ms. ZHANG Wei ( ੵᙯ) Building No. 4
Lanting Xuan
Dongli District
Tianjing
PRC
Chinese
Non-executive Directors
Mr. ZHU Jingyang ( ϡᘩජ)
(formerly named ZHU
Daqiang ( ϡɽ੶))
Floor 2, Building 1
No. 1 Courtyard
Shuijun Chang’an Jiayuan
Chaoyang District
Beijing
PRC
Chinese
Ms. TAO Sha ( ௗ୶) Unit 1
Centrium Residence
No. 3 BaiJiaZhuang Bei Li
Chaoyang District
Beijing
PRC
Chinese
DIRECTORS, SUPERVISORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 153 ---
Independent non-executive Directors
Ms. Christine Shaohua
LU-WONG ( ጅჭശ)
Flat A, 9/F
Block 19
Mei Foo Sun Chuen
Nassau Street
Kowloon
Hong Kong
American
Dr. ZHOU Demin ( մᅃઽ) 10/F, Building 26
No. 38 Xueyuan Road
Haidian District
Beijing
PRC
Chinese
M r .L IB o(تNo. 10, Lane 1500
Changyi Road
Pudong New Area
Shanghai
PRC
Chinese
SUPERVISORS
Name Address Nationality
Mr. XUE Mengjun (ࠏ֗No. 52, Lane 588
Lianhua South Road
Minhang District
Shanghai
PRC
Chinese
Mr. LIN Chonglan (ਫ਼ᖀ) No. 16, Lane 7677
Shenjiang South Road
Pudong New Area
Shanghai
PRC
Chinese
Ms. MA Rui ( ৵ြ) No. 18, Lane 550
Heyun Road
Pudong New Area
Shanghai
PRC
Chinese
See “Directors, Supervisors and Senior Management” for further details of our Directors
and Supervisors.
DIRECTORS, SUPERVISORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 154 ---
PARTIES INVOLVED IN THE GLOBAL OFFERING
Sole Sponsor CITIC Securities (Hong Kong) Limited
18/F, One Pacific Place
88 Queensway
Hong Kong
Sole Sponsor-Overall Coordinator CLSA Limited
18/F, One Pacific Place
88 Queensway
Hong Kong
Overall Coordinators CLSA Limited
18/F, One Pacific Place
88 Queensway
Hong Kong
BOCOM International Securities Limited
9/F, Man Y ee Building
68 Des V oeux Road Central
Central
Hong Kong
Fosun International Securities Limited
Suite 2101-2105
21/F Champion Tower
3 Garden Road
Central Hong Kong
ABCI Capital Limited
11/F
Agricultural Bank of China Tower
50 Connaught Road Central
Hong Kong
Capital Market Intermediaries CLSA Limited
18/F, One Pacific Place
88 Queensway
Hong Kong
BOCOM International Securities Limited
9/F, Man Y ee Building
68 Des V oeux Road Central
Central
Hong Kong
DIRECTORS, SUPERVISORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 155 ---
Fosun International Securities Limited
Suite 2101-2105
21/F Champion Tower
3 Garden Road
Central
Hong Kong
ABCI Capital Limited
11/F
Agricultural Bank of China Tower
50 Connaught Road Central
Hong Kong
ABCI Securities Company Limited
10/F
Agricultural Bank of China Tower
50 Connaught Road Central
Hong Kong
China Renaissance Securities
(Hong Kong) Limited
Units 8107-08, Level 81
International Commerce Centre
1 Austin Road West
Kowloon, Hong Kong
CCB International Capital Limited
12/F, CCB Tower
3 Connaught Road Central
Central, Hong Kong
GF Securities (Hong Kong) Brokerage
Limited
27/F, GF Tower
81 Lockhart Road
Wan Chai, Hong Kong
Joint Global Coordinators CLSA Limited
18/F, One Pacific Place
88 Queensway
Hong Kong
DIRECTORS, SUPERVISORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 156 ---
BOCOM International Securities Limited
9/F, Man Y ee Building
68 Des V oeux Road Central
Central
Hong Kong
Fosun International Securities Limited
Suite 2101-2105
21/F Champion Tower
3 Garden Road
Central
Hong Kong
ABCI Capital Limited
11/F
Agricultural Bank of China Tower
50 Connaught Road Central
Hong Kong
CCB International Capital Limited
12/F, CCB Tower
3 Connaught Road Central
Central, Hong Kong
Joint Bookrunners CLSA Limited
18/F, One Pacific Place
88 Queensway
Hong Kong
BOCOM International Securities Limited
9/F, Man Y ee Building
68 Des V oeux Road Central
Central
Hong Kong
Fosun International Securities Limited
Suite 2101-2105
21/F Champion Tower
3 Garden Road
Central
Hong Kong
DIRECTORS, SUPERVISORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 157 ---
ABCI Capital Limited
11/F
Agricultural Bank of China Tower
50 Connaught Road Central
Hong Kong
China Renaissance Securities
(Hong Kong) Limited
Units 8107-08, Level 81
International Commerce Centre
1 Austin Road West
Kowloon, Hong Kong
CCB International Capital Limited
12/F, CCB Tower
3 Connaught Road Central
Central, Hong Kong
GF Securities (Hong Kong) Brokerage
Limited
27/F, GF Tower
81 Lockhart Road
Wan Chai, Hong Kong
Joint Lead Managers CLSA Limited
18/F, One Pacific Place
88 Queensway
Hong Kong
BOCOM International Securities Limited
9/F, Man Y ee Building
68 Des V oeux Road Central
Central
Hong Kong
Fosun International Securities Limited
Suite 2101-2105
21/F Champion Tower
3 Garden Road
Central
Hong Kong
DIRECTORS, SUPERVISORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 158 ---
ABCI Securities Company Limited
10/F
Agricultural Bank of China Tower
50 Connaught Road Central
Hong Kong
China Renaissance Securities
(Hong Kong) Limited
Units 8107-08, Level 81
International Commerce Centre
1 Austin Road West
Kowloon, Hong Kong
CCB International Capital Limited
12/F, CCB Tower
3 Connaught Road Central
Central, Hong Kong
GF Securities (Hong Kong) Brokerage
Limited
27/F, GF Tower
81 Lockhart Road
Wan Chai, Hong Kong
Legal advisors to our Company As to Hong Kong and United States laws:
Davis Polk & Wardwell
10/F, The Hong Kong Club Building
3A Chater Road
Central
Hong Kong
As to PRC laws:
Jia Yuan Law Offices
32F, Building S1
The Bund Finance Center
No. 600, Zhongshan No. 2 Road (E)
Huangpu District, Shanghai
PRC
DIRECTORS, SUPERVISORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 159 ---
As to PRC intellectual property law:
JunHe LLP
26/F, HKRI Centre One
HKRI Taikoo Hui
288 Shimen Road (No.1)
Shanghai
PRC
As to United States intellectual property
law:
Jun He Law Offices P.C.
20380 Town Center Lane, Suite 128
Cupertino, CA 95014
USA
As to the laws of European Patent
Convention and the national patent laws of
EPC contracting countries:
2K Patentanwälte — München
Bajuwarenring 14
D-82041 Oberhaching
Germany
Legal advisors to the Sole Sponsor
and the Underwriters
As to Hong Kong and United States laws:
Sullivan & Cromwell (Hong Kong) LLP
20th Floor, Alexandra House
18 Chater Road
Central
Hong Kong
DIRECTORS, SUPERVISORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 160 ---
As to PRC laws:
Jingtian & Gongcheng
45/F, K. Wah Centre
1010 Huai Hai Road (M)
Xu Hui District
Shanghai
China
Auditor and Reporting Accountants Ernst & Y oung
Certified Public Accountants
Registered Public Interest Entity Auditor
27/F, One Taikoo Place
979 King’s Road
Quarry Bay
Hong Kong
Industry Consultant Frost & Sullivan (Beijing) Inc.,
Shanghai Branch Co.
Suite 2504
Wheelock Square
1717 Nanjing West Road
Shanghai
China
Compliance Advisor Guotai Junan Capital Limited
26/F-28/F, Low Block
Grand Millennium Plaza
181 Queen’s Road Central
Hong Kong
Receiving Bank China CITIC Bank International Limited
80 Floor, International Commerce Centre
1 Austin Road West
Kowloon
Hong Kong
DIRECTORS, SUPERVISORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 161 ---
Registered Office, headquarter and
Principal Place of Business in the PRC
Floors 2, 3, 4, and 5, Building 8
1206 Zhangjiang Road
(Shanghai) Pilot Free Trade Zone
PRC
Principal Place of Business in Hong Kong 46/F., Hopewell Centre
183 Queen’s Road East
Wan Chai, Hong Kong
Company’s Website http://www.genfleet.com
(the information contained on this website
does not form part of this Prospectus)
Joint Company Secretaries Ms. ZHANG Wei ( ੵᙯ)
Floors 2, 3, 4, and 5, Building 8
1206 Zhangjiang Road
(Shanghai) Pilot Free Trade Zone
PRC
Mr. NG Tung Ching Raphael (ᆋ)
(Associate Member of both The Hong Kong
Chartered Governance Institute and The
Chartered Governance Institute in the
United Kingdom)
46/F., Hopewell Centre
183 Queen’s Road East
Wan Chai
Hong Kong
Authorized Representatives Ms. ZHANG Wei ( ੵᙯ)
Floors 2, 3, 4, and 5, Building 8
1206 Zhangjiang Road
(Shanghai) Pilot Free Trade Zone
PRC
Mr. NG Tung Ching Raphael (ᆋ)
46/F., Hopewell Centre
183 Queen’ Road East
Wan Chai
Hong Kong
CORPORATE INFORMATION
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--- page 162 ---
Audit Committee Ms. Christine Shaohua LU-WONG ( ጅჭശ)
(chairperson)
Mr. ZHU Jingyang ( ϡᘩජ)
Dr. ZHOU Demin ( մᅃઽ)
Remuneration Committee M r .L IB o(ت)chairperson)
Dr. Jiong LAN
Dr. ZHOU Demin ( մᅃઽ)
Nomination Committee Dr. Qiang LU (chairperson)
Ms. Christine Shaohua LU-WONG ( ጅჭശ)
M r .L IB o(ت)
H Share Registrar Computershare Hong Kong Investor
Services Limited
Shops 1712-1716
17th Floor Hopewell Centre
183 Queen’s Road East
Wan Chai, Hong Kong
Principal Banks Bank of Ningbo Co., Ltd. (Shanghai
Branch)
1/F, Haiyin Financial Centre
No. 8 Middle Yincheng Road
Pudong New Area
Shanghai
PRC
China Merchants Bank Co., Ltd.
(Shanghai Zhangjiang Branch)
1/F, Building 2
German Centre
No. 88 Ke Y uan Road
Zhangjiang Town
Pudong New Area
Shanghai
PRC
CORPORATE INFORMATION
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--- page 163 ---
Certain information and statistics set out in this section have been extracted from
various official government publications, available sources from public market data
providers and an Independent Third-Party source, Frost & Sullivan. The report prepared
by Frost & Sullivan and cited in this document was commissioned by us. We believe that
the sources of this information are appropriate sources for such information and have
taken reasonable care in extracting and reproducing such information. We have no reason
to believe that such information is false or misleading or that any fact has been omitted
that would render such information false or misleading. The information from official
government sources has not been independently verified by us, the Sole Sponsor , the Sole
Sponsor-Overall Coordinator , the Overall Coordinators, the Joint Global Coordinators,
the Joint Bookrunners, the Joint Lead Managers, the Underwriter(s), any of their
respective directors, employees, agents or advisors or any other person or party involved
in the Global Offering, and no representation is given as to its accuracy, fairness and
completeness. For discussion of the risks relating to our industry, see “Risk Factors” in
this Prospectus.
OVERVIEW OF ONCOLOGY DRUG MARKET
Overview
Cancer is a broad group of diseases that involve uncontrolled growth and development of
cells in the body, and is one of the foremost reasons of deaths throughout the world. Over the
past century, cancer treatments have experienced significant evolution from surgery,
radiotherapy, chemotherapy, immuno-oncology therapies to targeted therapies, such as small
molecule targeted therapies and antibody-based therapies. Among these advancements, the
development of Rat sarcoma (“ RAS”)-targeting therapies has answered to the long-term
struggles by directly targeting Kirsten rat sarcoma (“ KRAS ”), one of the most frequently
mutated oncogenes in cancer and which has historically been considered “undruggable.”
With the advanced cancer treatments today, there continue to be growing medical needs
for differentiated therapeutics to improve duration of response and overall survival in oncology
patients. Carcinogenesis is a highly complex biological process, and certain treatment methods
that have shown to be effective for certain types of cancers may be less effective for others.
Cancer cells could also become resistance to certain treatments due to, for example, activation
of a signaling pathway through overactivation of downstream components. Additionally, the
aging population and unhealthy lifestyle choices also drive up the cancer incidence globally.
INDUSTRY OVERVIEW
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--- page 164 ---
Market Size of Oncology Drugs
Cancer is the leading cause of death worldwide, resulting in approximately 10 million
deaths globally each year. There were 21.3 million new cancer cases globally in 2024, and it
was estimated that as of 2033, there would be 26.0 million new cancer cases. The diagram
below illustrates the top 10 cancer types by incidence globally in 2024, among which lung
cancer, breast cancer and colorectal cancer were the top three cancers by global incidence. In
China, lung cancer, colorectal cancer and thyroid cancer were the top three cancers by
incidence as of 2024.
China and Global Top 10 Cancers by Incidence in 2024
Thousands1,113.8
542.4 479.1 382.8 376.1 372.7
235.5 152.7 143.3 125.0
BreastLung Colorectum ProstateStomachLiverThyroid Esophagus Pancreas Cervix uteri
Thousands2,592.4 2,384.1
2,005.2
1,521.0
1,017.0 905.6 845.9 692.2 660.0 637.4
BreastLung Colorectum Prostate Stomach Liver Thyroid Lymphoma Bladder Cervix uteri
Note: Head and neck cancer is a collective term for cancers that occur in various parts of the head and neck, so it
is not included in the ranking of single cancer incidence.
Source: Globocan, IARC, NCCR, Frost & Sullivan analysis
The global oncology drug market has expanded significantly in the past and is projected
to further grow. The global oncology drug market grew from US$143.5 billion in 2019 to
US$253.3 billion in 2024 with a CAGR of 12.0%, and is expected to further grow to US$596.7
billion in 2033 with a CAGR of 10.0% from 2024 to 2033. Greater China’s oncology drug
market has also grown rapidly in recent years. Its size grew from US$26.4 billion in 2019 to
US$35.9 billion in 2024 with a CAGR of 6.3%, and is expected to further grow to US$114.1
billion in 2033 with a CAGR of 13.7% from 2024 to 2033.
In recent years, an increasing number of innovative cancer therapies have been approved
globally. It is expected that more innovative drugs with better efficacy and/or less adverse
effects than currently available therapies will continue to emerge. The following charts
illustrate the historical and projected expansion of global and Greater China’s oncology drug
markets.
INDUSTRY OVERVIEW
– 155 –


--- page 165 ---
Global and Greater China Oncology Drug Market, 2019-2033E
Period Greater ChinaU.S. ROW Global
CAGR
2019-2024
2024-2033E
12.0%
10.0%
15.7%
9.6%
6.3%
13.7%
11.2%
9.0%
Billion USD
143.5 150.3
181.7 205.1
228.9 253.3
279.5
310.3
343.5
375.9
410.8
452.5
498.8
596.7
548.2
20202019 2021 2022 2023 2024 2025E 2026E 2028E 2029E 2030E 2031E 2032E 2033E2027E
67.8 70.5 84.7 95.5 105.0 115.3 127.0 139.7 153.3 167.4 182.0 197.5 214.0 231.6 250.2
26.4 28.6 35.8 34.7 34.1 35.9 39.0 42.7 47.8 54.3 62.9 73.4 85.8 99.2
114.1
49.2 51.2 61.2 74.9 89.7 102.1 113.5
127.9 142.4
154.3
166.0
181.7
199.0
217.4
232.4
Greater ChinaUS ROW
Source: Frost & Sullivan Analysis
The global oncology drug markets for the treatment of NSCLC, CRC and pancreatic
cancer represent considerable market size and growth potential in light of their prevalence and
relatively large proportion of patients with unresectable tumor and/or at advanced stages. The
diagrams below set forth the historical and projected market size of these three cancer types
from 2019 to 2033, respectively.
Global and Greater China NSCLC Drug Market Size, 2019-2033E
Greater ChinaPeriod ROW
CAGR
2019-2024
2024-2033E
12.4%14.7%
Billion USD
50.2 52.8 60.6 68.6 78.3
91.2
105.2
119.7
135.3
152.0
167.7
182.2
213.9
197.5
231.2
20202019 2021 2022 2023 2024 2025E 2026E 2028E 2029E 2030E 2031E 2033E2032E
8.3 8.0 8.8 10.5 15.1 17.6
2027E
20.0 22.4 24.8 27.3 33.030.1
44.9 46.3 52.3 60.6 69.6 80.7
104.6
12.7
92.6
117.6 132.0 145.3
157.4 170.2
198.2
183.8
Greater China ROW
13.6% 10.5%
Global
12.7%
10.9%
5.3 6.5
Source: NMP A, FDA, Annual Reports, Frost & Sullivan Analysis
INDUSTRY OVERVIEW
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--- page 166 ---
Global and Greater China CRC Drug Market Size, 2019-2033E
Greater China ROWPeriod
CAGR
2019-2024
2024-2033E
8.2%10.7%
Billion USD
16.9 17.4 19.0 20.6 22.9
25.4
31.0
28.2
34.1
37.2
40.6
44.0
47.6
55.0
51.2
20202019 2021 2022 2023 2024 2025E 2026E 2028E 2029E 2030E 2031E 2032E 2033E
2.0 2.2 2.5 2.6 2.9 3.4 3.9 4.6
2027E
5.4 6.2 7.0 7.7 8.5 10.09.2
14.9 15.2 16.5 18.0 22.120.0 24.3 26.4 28.6 31.0 33.6 36.3
39.1
42.0
45.0
Greater China ROW
12.9% 8.2%
Global
8.5%
8.9%
Source: NMP A, FDA, Annual Reports, Frost & Sullivan Analysis
Global and Greater China Pancreatic Cancer Drug Market Size, 2019-2033E
Billions USD
1.9 2.1 2.3
2.72.5
2.8 3.0 3.3
3.6
3.9
4.2
4.6
5.0
5.5
6.0
20202019 2021 2022 2023 2024 2025E 2026E 2028E 2029E 2030E 2031E 2033E2032E
0.4 0.4 0.50.5 0.5 0.5 0.5 0.5 0.6
2027E
0.6 0.7 0.8 0.9 1.0 1.2
1.5 1.7 1.8 2.22.0 2.3 2.5 2.7 3.0 3.3 3.6
3.9
4.2
4.5
4.8
Greater China ROW
Greater China ROWPeriod
CAGR
2019-2024
2024-2033E
8.5%4.6%
10.4% 8.5%
Global
7.8%
8.8%
Source: NMP A, FDA, Annual Reports, Frost & Sullivan Analysis
INDUSTRY OVERVIEW
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--- page 167 ---
The table below sets forth the proportion of unresectable and/or advanced stages of
NSCLC, CRC and pancreatic cancer cases, respectively.
Proportion of Different Stages of Major Cancer Types
NSCLC CRC PC
• 22% of patients were diagnosed as
early stage (stage I-II), 21% as locally
advanced stage (stage III), and 53%
as late stage patients
• 30% to 55% of patients with NSCLC
develop recurrence and die of their
disease despite curative resection
• 35% of patients were diagnosed as
early stage (stage I-II), 36% as locally
advanced stage (stage III), and 23%
as late stage patients
• After treatment with curative intent,
30% to 40% of the patients develop
recurrent disease; thus 43.8% were
diagnosed at late stage
• 14% of patients were diagnosed as
early stage (stage I-II), 29% as locally
advanced stage (stage III), and 51%
as late stage patients
• At present, radical surgery is the only
way to cure pancreatic cancer, while
the recurrence rate within 2 years
after surgery is 66%~92%
• 16% of patients were diagnosed as
early stage (stage I-II), 22% as locally
advanced stage (stage III), and 57%
as late stage patients
• Surgical treatment is the first choice
for early to mid stage patients,
however, the postoperative
recurrence and metastasis rate is still
as high as 45.4%
• 56.2% of patients were diagnosed as
early to mid stage, thus 43.8% were
diagnosed at late stage
• The recurrence rate after radical
surgery for colorectal cancer is 30% to
40%
• The early diagnosis rate of pancreatic
cancer was only 5%, the resectable
pancreatic cancer was 15%~20%,
thus 80%~85% should accept drug
treatment at diagnose;
• The tumor recurrence rates at 2 years
after radical resection is 79%
20%-40% are resectable cancers,
including most stage I-IIIa and a small
proportion of stage IIIb lung cancers
Almost all patients with initially
diagnosed non-metastatic and
partially metastatic CRC can be
resected, and systemic treatment can
transform partially unresectable CRC
into resectable. There is no relevant
research on the specific proportion
Resectable PC accounts for only
approximately 10%-15% of total PC
Legends:
and 53% and 23%
thus 43.8% were
diagnosed at late stage
40%
The recurrence rate aftff er radical
surgery foff r colorectal cancer is 30% to
and 57%
as late stage patients as late stage patients
Aftff er treatment with curative intent,
30% to 40% of the patients develop
recurrent disease; thus 43.8% were
diagnosed at late stage
as late stage patients
develop recurrence
as high as 45.4%
30% to 55% of patients with NSCLC
recurrence and metastasis rate is still
51%
as late stage patients
recurrence rate within 2 years
thus 80%~85% should accept drug
treatment at diagnose;
The tumor recurrence rates at 2 years
aftff er radical resection is 79%
aftff er surgery is 66%~92%
patients targeted by GFH925 and GFH375.
patients targeted by GFH375.
Source: Literature review, Frost & Sullivan Analysis
Growth Drivers and Future Trends of Oncology Drug Market
According to Frost & Sullivan, the growth of oncology drug market has primarily been
driven by the following factors:
 Unmet Clinical Needs. In 2024, the global cancer incidence reached 21.3 million
cases, which can be attributed to various factors such as an aging population,
environmental pollution, and the prevalence of unhealthy lifestyle choices including
smoking, physical inactivity and high-calorie diets. As a result, the number of cancer
patients worldwide is expected to increase, leading to a corresponding expansion of
the oncology drug market.
 Emerging Innovative Therapies . Innovative therapies such as ADCs and targeted
inhibitors are emerging treatment modalities for certain types of cancers. These
therapies have made significant clinical progress with the increasing understanding
of tumorigenesis mechanism and the use of evolving techniques to formulate such
innovative therapies.
 Targeted Therapies . Targeted therapy is an approach to diagnose and treat cancer
that leverages information of an individual’s genotypes and associated factors.
Statistics show that over 85% of the oncology market is now centered around
targeted therapies. Targeted therapy enables physicians to formulate personalized
and effective treatment options by incorporating cancer DNA (such as oncogenes)
analysis into tailored cancer therapies with enhanced treatment outcomes.
INDUSTRY OVERVIEW
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--- page 168 ---
 General Support Care . Supportive care services focus on supportive therapy that
helps relieve pain, distress and other symptoms that can accompany serious illness.
Substantial needs have developed around support care. For instance, around 30% of
cancer-related deaths are associated with cachexia, symptoms not only impact
patient tolerability to treatment but also significantly deteriorate their quality of life.
Developing treatments for chronic diseases-induced symptoms is crucial for
prolonging patient survival, improving quality of life, and saving medical costs.
 Expanding Combination Therapy . Combining different therapies, such as small
molecule inhibitors with immunotherapy, has the potential of increasing the efficacy
of cancer treatment and represents a promising direction for the development of
oncology drugs.
OVERVIEW OF RAS DRUG MARKET
RAS is a family of proteins that exhibits a guanosine triphosphatase (“ GTPase ”) activity
and cycles between “on” guanosine triphosphate (“ GTP”)-bound and “off” guanosine
diphosphate (“ GDP”)-bound states. RAS protein regulates multiple signal transductions and
plays a role in the cascade of cell process control, including cell proliferation and cell division.
Three RAS genes encode for protein isoforms, namely KRAS, Harvey Ras (“ HRAS ”) and
Neuroblastoma Ras (“ NRAS ”). KRAS is one of the most frequently mutated oncogenes in
human cancers and it represents approximately 75% of all RAS isoforms contributing to
cancer. KRAS mutations are detected in approximately 90% of pancreatic cancer, 30-40% of
colorectal cancer (“ CRC”), and 15-20% of lung cancer patients. These mutations are often
associated with resistance to targeted therapies and poor outcomes in cancer patients.
The major players in the RAS drug industry include Mirati (acquired by Bristol Myers
Squibb (NYSE: BMS) in 2024) and Revolution Medicines (NASDAQ: RVMD). The following
table sets forth the RAS product matrix of Mirati and Revolution Medicines.
Mirati RAS Product Matrix Revolution Medicines RAS Product Matrix
StageApproachT reatment
LineIndicationDrug
Phase IIIMono2L+PDAC
RMC-6236
(Pan-Ras
Inhibitor)
Phase IIIMono
2L+NSCLC
Phase I/ IICombo with
Pembrolizumab
Phase I/ IICombo with
chemo/anti E GFR1L+Gastrointestinal
solid tumors
Phase IMono2L+Solid tumors
Phase IMono/Combo with
RMC-62362L+Solid tumorsRMC-6291
(Kras G12C
Inhibitor) Phase I/IICombo with
Pembrolizumab2L+NSCLC
Phase IMono/Combo with
RMC-62362L+Solid tumors
RMC-9805
(Kras G12D
Inhibitor)
StageApproachT reatment
LineIndicationDrug
ApprovedMono2L+NSCLC
KRAZATI
(adagrasib,
KrasG12C
Inhibitor)
ApprovedCombo with
Cetuximab2LCRC
Other 5+pepelines exploring different drug combinations and
expanding  indications
Phase I/IIMono/Combo with
KRAZATI1L+Solid tumors
MRTX0902
(SOS1:KRAS
Inhibitor)
Source: Official Website, Annual Report, ClinicalTrials.gov, Frost & Sullivan
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Overview of KRAS G12C Drugs
One of the most common mutations in the KRAS gene is G12C, accounting for
approximately 15% of all KRAS mutations, and it is also the most prevalent variant of KRAS
mutations in non-small-cell lung cancer (“ NSCLC ”). The KRAS G12C variant favors the
active form of the KRAS protein, resulting in a predominantly GTP-bound KRAS oncoprotein.
This leads to enhanced proliferation and survival in tumor cells. The KRAS G12C mutation
occurs in approximately 13% of NSCLC and in 3% to 4% of CRC.
While the first commercially-available KRAS G12C inhibitors have shown promising
efficacy results, drug resistance including secondary mutations and bypass activation of other
signaling pathways, and certain side effects such as gastrointestinal toxicity have been
observed in their clinical applications. Therefore, emerging KRAS G12C inhibitor drugs to
further combat resistance and with improved safety profiles could potentially bring additional
clinical benefits to patients.
Market Size of KRAS G12C Inhibitor Drugs
GFH925 (fulzerasib) was the first KRAS G12C inhibitor drug that received approval for
commercialization in China. Globally, there were four other KRAS G12C inhibitor (adagrasib,
sotorasib, garsorasib and glecirasib) drugs that have been approved as of the Latest Practicable
Date. GFH925, as a KRAS G12C inhibitor, is not designed or expected to eliminate drug
resistance or certain side effects, such as gastrointestinal toxicity, associated with other
approved KRAS G12C inhibitor drugs. The following table sets forth such marketed products.
KRAS G12C Inhibitor Drugs Approved Globally
Brand
Name
Generic
Name Company Indication Treatment
Line
Nature of Drug
Program
First Approval
Time
Route of
Administration Efficacy Safety Treatment
schedules
Annual Cost
(thousand USD)
Annual
Sales
(2023)
Reimbursement
coverage
༺Ьत Fulzerasib Innovent/GenFleet
KRAS G12C
mutated
advanced
NSCLC adult
patients
2L+ Mono 2024/08/21 (NMPA) oral
ORR 49.1%
DCR 90.5%
mPFS 9.7 months
OS 13.3 months
SAE 14.0%,
TRAEs led to dose
reduction 18.3%,
drug interruption
32.6%, permanent
discontinuation 2.7%
600 mg, BID 31.0 – No
τ˙ྐྵ Garsorasib Chia Tai
Tianqing/Inventisbio
KRAS G12C
mutated
advanced
NSCLC adult
patients
2L+ Mono 2024/11/08 (NMPA) oral
ORR 52.0%
DCR 88.6%
mPFS 9.1 months
OS 14.1 months
TRAEs 95.9%
TRAEs led to dose
reduction 30.1%,
drug interruption
41.5%, permanent
discontinuation 0%
600 mg, BID 35.0 – No
Ў๿௱ Glecirasib Jacobio/Allist
KRAS G12C
mutated
advanced
NSCLC adult
patients
2L+ Mono 2025/5/20 (NMPA) oral
ORR 49.6%
DCR 86.3%
mPFS 8.2 months
OS 13.6 months
TRAEs 97.5%
TRAEs led to dose
reduction 37.8%,
drug interruption
18.5%, permanent
discontinuation 5%
800 mg, QD NA – No
Krazati Adagrasib BMS
KRAS G12C
mutated locally
advanced or
metastatic
NSCLC adult
patients
2L+ Mono 2022/12/12 (FDA)
2024/01/05 (EMA)
oral
ORR 42.9%
mPFS 6.5 months
OS 12.6 months
TRAEs led to dose
reduction 28%,
drug interruption
77%, permanent
discontinuation 13%
600 mg, BID 280.0 126 million
USD
KRAS G12C
mutated
metastatic
CRC
2L Combo with
cetuximab 2024/06/21 (FDA)
ORR 34%
DCR 85.1%
mPFS 6.9 months
mOS 15.9 months
TRAEs led to dose
reduction 35%,
drug interruption
62%, permanent
discontinuation
2 patients
(about 0.02%)
KRAS G12C
mutated
metastatic
CRC
2L combo with
panitumumab 2025/1/17 (FDA)
ORR 26%
mPFS 5.6 months
mOS Not Reached
TRAE 45.3%
Lumakras Sotorasib Amgen
KRAS G12C
mutated locally
advanced or
metastatic
NSCLC adult
patients
2L+ Mono
2021/05/28 (FDA)
2022/01/06 (EMA)
2022/01/20 (PMDA)
oral
ORR 37.1%
DCR 80.6%
mPFS 6.3 months
mOS 12.5 months
SAE 14.0%,
TRAEs led to dose
reduction 5%,
drug interruption
34%, permanent
discontinuation 9% 960 mg, QD 266.9
350
million
USD
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Notes:
1. The annual cost is calculated based on the patient using the product for one year and price in 2025. The
significant differences of annual costs of approved KRAS G12C inhibitor drugs in China and U.S. are due to
the differences in healthcare systems between the two countries, including pricing mechanism, insurance
payment system, spending power and R&D costs.
2. The reimbursement coverage only applies to drugs approved by the NMPA, and drugs listed in the United
States are covered by different commercial insurances, which cannot be exhaustive.
Source: Annual Report, FDA, EMA, PMDA, NMP A, Frost & Sullivan Analysis
With the continuous market penetration of the commercialized KRAS G12C inhibitor
drugs and development of new drugs, the global KRAS G12C inhibitor drug market is expected
to grow rapidly from US$489.1 million in 2024 to US$3,490.7 million in 2033 with a CAGR
of 24.4%.
The Global KRAS G12C inhibitor drug market for NSCLC rose from US$90.0 million in
2021 to US$464.7 million in 2024 with a CAGR of 72.8% during the period. It is expected to
continue increasing to US$2,757.6 million by 2033, reflecting a CAGR of 21.9% from 2024.
The Global KRAS G12C inhibitor drug market for CRC was US$24.5 million in 2024 and is
expected to continue increasing to US$733.0 million by 2033, reflecting a CAGR of 45.9%
from 2024.
The Greater China KRAS G12C inhibitor drug market for NSCLC was US$13.1 million
in 2024 and is expected to continue increasing to US$559.8 million by 2033, reflecting a
CAGR of 51.7% from 2024. The Greater China KRAS G12C inhibitor drug market for CRC
is expected to develop in 2027 with a market size estimated to be US$4.3 million in 2027 and
is expected to continue increasing to US$87.4 million by 2033.
The diagram below sets forth the historical and projected global market size of KRAS
G12C inhibitor drugs from 2021 to 2033.
Global KRAS G12C Inhibitor Drug Market, 2021-2033E
CAGR
2021-2024
2024-2033E
Greater China
-
54.2%
Global
75.8%
24.4%
Million USD
2021 2022 2023 2024 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E
90.090.0 318.9318.9285.0285.0 476.0476.0
126.7126.713.113.1 161.7161.7 213.0213.0 282.7282.7 356.7356.7 436.1436.1 504.0504.0 574.6574.6 647.1647.1665.0665.0 889.4889.4
1,114.61,114.6
1,741.61,741.6
1,408.01,408.0
2,071.72,071.7
2,346.52,346.5
2,595.62,595.6
2,843.62,843.6
Greater China ROW
318.9285.0
90.0
489.1
791.7
1,051.1
1,327.6
1,690.7
2,098.3
2,507.7
2,850.5
3,170.2
3,490.7
Source: NMP A, FDA, Annual Reports, Frost & Sullivan Analysis
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The assumptions for the future market forecast of KRAS G12C inhibitor drugs globally
are as follows.
1. Rich global clinical pipeline
There are multiple drug candidates that have reached the Phase III stage or further,
and we assume that there will be more drugs being approved in the near future. Also,
ongoing global R&D efforts are expected to expand the indications of KRAS G12C
inhibitor drugs to CRC and other cancer types. Lumakras has been approved by the FDA
for second-line treatment of CRC patients worldwide in January 2025, and China, as one
of the major markets, also have one more approved product (Garsorasib, τ˙ྐྵ) and one
NDA product (JMKX001899) in 2025, which will jointly drive market growth. In
addition, we expect the first-line treatment approval in NSCLC patients around 2028.
Thus, the market size of KRAS G12C inhibitor drugs has considerable growth potential.
2. Improved drug accessibility enables faster drug penetration and domestic products
expanding overseas
The first KRAS G12C inhibitor in China, Fluzeleise ( ༺Ьत), has reduced its price
by 25.3% in the second year after its launch, and plans to participate in the adjustment
of the national medical insurance catalog in 2025. The Glecirasib ( Ў๿௱) commercial
insurance project will provide insurance support for patients starting from June 2025.
These will enable more patients to afford treatment and improve patient compliance.
Besides, KRAS G12C inhibitor drugs approved in China, such as fulzerasib and
garsorasib, are undergoing clinical trials overseas. We assume that these drugs will have
market potential both in China and globally.
3. Urgent needs for KRAS G12C targeted therapy
For a long time, KRAS G12C mutation positive patients lacked targeted drugs.
There are approximately 300 thousands new cases of KRAS G12C mutant NSCLC
globally each year, with 85-90% of them at locally advanced or metastatic stage, 90-95%
of people receiving first-line treatment, and about 55% of patients entering second line
treatment. For KRAS G12C mutant CRC, the number of new cases, late stage proportion,
first line treatment rate and second line treatment rate are 70 thousands, 55-70%, 90-95%
and 60-65% respectively. With the approval of effective targeted drugs for the mutation,
we assume that the penetration rates of these KRAS G12C targeted drugs will mirror the
previous development of EGFR-targeted drugs, i.e., reaching a high level.
The slowdown in the growth rate of the global KRAS G12C inhibitor market in 2023
is mainly due to the decline in revenue of Lumakras. According to Amgen’s financial
report, this is mainly due to unfavorable changes to estimated sales deductions, including
changes related to ongoing reimbursement negotiations in France. Full year sales were
also impacted by lower net selling price and lower inventory levels, but noticeably, the
annual sales volume increased by 16%. However, such reimbursement negotiations in
France did not have material impact on the revenue of Lumakras in 2022 or 2024;
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The main reasons for the accelerated growth in 2024 are:
 Kkrazati has been approved in EU and indication expansion in US. In 2023,
krazati was only approved by the FDA for second-line and above treatment of
locally advanced or meta static NSCLC adult patients with KRAS G12C
mutation. In January 2024, the same indication was approved in Europe, and
in June 2024, the FDA approved the extension of the indication to KRAS G12C
mutated meta static CRC second-line treatment;
 Lumakras volume growth and favorable changes to estimated sales deductions;
and
 The first KRAS G12C inhibitor was approved in China and quickly begins
commercialization.
Growth Drivers for KRAS G12C Inhibitor Drug Market
According to Frost & Sullivan, the growth of KRAS G12C inhibitor drug market has
primarily been driven by the following factors:
 Large number of addressable patients with Increasing Diagnostic Rates. Globally,
approximately 300 thousands new cases of KRAS G12C-mutated NSCLC and
70 thousands cases of KRAS G12C-mutated CRC annually. Current first-line
treatment options for these patients—including chemotherapy, immunotherapy, and
their combinations—demonstrate limited efficacy, highlighting significant unmet
clinical needs. Concurrently, the rapid adoption of companion diagnostics has
facilitated the advancement of precision medicine, establishing a solid foundation
for the KRAS G12C inhibitor market.
 Exploration of Combination Therapies and Indication Expansion. Ongoing clinical
researches are focusing on combination regimens involving KRAS G12C inhibitors
with anti-EGFR, anti-VEGF, and SHP2 inhibitors, aiming to evaluate their potential
in first-line treatment settings. Additionally, studies exploring the expansion of these
therapies into other indications, such as pancreatic cancer (PC), are actively
progressing, promising further market growth.
 Policy Support Accelerating Approval and Improving Patient Access. China’s first
KRAS G12C inhibitor, Fuzuresib, has confirmed to enter the national
reimbursement negotiation process with a 25% price reduction. If successfully
included in the national reimbursement drug list (NRDL), it will substantially
enhance patient accessibility. Furthermore, the “White Paper on Quality of Life for
Chinese KRAS G12C Patients” project, initiated in April 2025 under the guidance
of the Chinese Anti-Cancer Association, aims to comprehensively analyze patient
survival status and drive the optimization of precision medicine models.
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Alternate therapeutic options
NSCLC
For first line treatment of NSCLC: Chemotherapy, immunotherapy, and chemotherapy
combined with immunotherapy;
For second and subsequent lines treatment of NSCLC:
 China: other approved KRAS G12C inhibitor, including garsorasib ( τ˙ྐྵ),
Glecirasib ( Ў๿௱)
 Global: other approved KRAS G12C inhibitor, including Krazati, Lumakras
CRC
for second line treatment
 China: Chemotherapy, targeted drugs (cetuximab/bevacizumab), PD-(L)1
immunotherapy, irinotecan and other drugs used alone or in combination
 Global: Krazati, Lumakras
The impact on the market potential and acceptance of GFH925
At present, the impact of other alternative treatment options on GFH925 in the target
indications mainly comes from other approved KRAS G12C inhibitors. There are currently
single drug efficacy data of competitors in China that are close to or even partially better than
GFH925, which may affect doctors’ preferences and divert some market share. However,
overall, GFH925 has significant advantages in multiple aspects, including impressive data in
combination with cetuximab, a first mover advantage in China, and the potential for the first
medical insurance coverage to accelerate commercial penetration. It has also been included in
guidelines to further consolidate its position as a second-line treatment. Therefore, the current
alternative treatment options have little impact on the potential and acceptance of GFH925.
From a global market perspective, due to the strong commercial foundation of
competitors, BMS and Amgen have mature KOL relationships, medical insurance negotiation
experience, and market education capabilities overseas, making it difficult to convert doctors’
prescription preferences in the short term. Also, GFH925, as a KRAS G12C inhibitor, is not
designed or expected to eliminate drug resistance or certain side effects, such as
gastrointestinal toxicity, associated with other approved KRAS G12C inhibitor drugs. If
GFH925 is approved overseas, its commercialization challenges will be significant. However,
GFH925 has efficacy and price advantages. Its efficacy data is comparable or superior to the
other two products based on the published clinical trial data (though no head to head clinical
trial has been conducted for efficacy comparison), which may become a key driving force for
physicians to try dressing changes.
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The following chart represents comparison of GFH925 with other approved KRAS G12G
inhibitors.
GFH925
Other KRAS G12C Inhibitors
Domestic Imported
MoA /H1118/H1118/H1118/H1118Highly comparable, each targeting the cysteine residue of the KRAS G12C protein to disable its
activity
Approved
Indication /H1118
NSCLC NSCLC, CRC
Pricing /H1118/H1118/H1118Similar, significantly lower than imported products High
Efficacy* /H1118/H1118The optimal DCR and mPFS
data for monotherapy of
NSCLC, with outstanding
control of brain metastasis
The ORR data for the
monotherapy of NSCLC with
glecirasib is optimal, and the
OS may be longer
The main safety data in NSCLC
are inferior to domestic
drugs, and the effectiveness
data in CRC is determined
Safety* /H1118/H1118/H1118Common TRAEs include
anemia, elevated alanine
aminotransferase, etc. Most
of them can be controlled by
interrupting treatment or
reducing dosage, and overall
safety is controllable
Glecirasib TRAEs mainly
include liver and
gastrointestinal events, while
Garsorasib TRAEs include
anemia, elevated blood
bilirubin, and elevated
alanine aminotransferase, all
of which are overall safe and
controllable
The most common TRAEs are
gastrointestinal and liver
related events, mostly of low
severity, and overall safety is
controllable
All of the above approved products encounter the issue of drug resistance that is
commonly observed across the KRAS G12C inhibitor class.
Note:
* Based on the published clinical trial data, not head-to-head clinical trials.
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Competitive Landscape of KRAS G12C Inhibitors
As of Latest Practicable Date, there were more than 20 KRAS G12C inhibitor candidates
being clinically developed globally. The following table sets forth the KRAS G12C inhibitor
candidates with at least a Phase III clinical trial globally as well as commercialized G12C
inhibitors.
Pipeline of KRAS G12C Inhibitor Candidates with Phase III Clinical Trial
and Beyond Globally
Drug Indication Latest
status Company Therapeutic
strategy
Treatment
line
Route of
Administration Treatment Schedules Efficacy & Safety Country
/region
First
posted
date
༺Ьत
(Fulzerasib)
advanced NSCLC Approved
Innovent/Genfleet
mono 2L+
oral
600mg, BID
ORR 49.1%
DCR 90.5%
mPFS 9.7 months
OS 13.3 months
SAE 14.0%,
TRAEs led to dose
reduction 18.3%, drug
interruption 32.6%,
permanent
discontinuation 2.7%
China 2024-08-21
(NMPA)
advanced non-sq
NSCLC Phase 1b/3
combo with
sintilimab±chem
otherapy
1L
GFH925 recommended
dose ± sintilimab
200mg Q3W ±
cetuximab 500mg/m
2
Q2W ± chemotherapy
ORR 45.5%
mPFS 9.6 months
TRAE 95.5%
TRAE (grade ≥3)
36.4%
China 2022-09-14
metastatic CRC Phase 1b/3 combo with
Cetuximab NA
GFH925 recommended
dose + cetuximab
500mg/m
2 Q2W
ORR 45.8%
DCR 89.6%
TRAE (grade 3) 23.2%
TRAE (dose reduction)
10.7%
TRAE (interruption)
21.4%
China 2022-08-09
advanced NSCLC Phase 1b/2 combo with
cetuximab 1L
GFH925 600mg BID
with cetuximab
500mg/m
2 Q2W,
28-day cycle
ORR 80.0%
mPFS 12.5 months
TRAE (dose reduction)
29.8%
EU 2023-03-06
advanced solid
tumors Phase 1/2 mono NA 700mg QD or
450/600/750mg BID
NSCLC: ORR 61.2%,
DCR 92.5%, TRAE
(any grade) 94.0%,
TRAE (grade ≥3) 31.3%
600mg BID dose group:
ORR 66.7%, DCR
96.7%, mPFS 8.2
months
China 2021-08-12
τ˙ྐྵ
(Garsorasib)
advanced NSCLC Approved
Chia Tai
Tianqing/
Inventisbio
mono 2L+
oral
600mg, BID
ORR 52.0%
DCR 88.6%
mPFS
9.1 months
OS 14.1 months
TRAEs 95.9%
TRAEs led to dose
reduction 30.1%, drug
interruption 41.5%,
permanent
discontinuation 0%
China 2024-11-08
(NMPA)
advanced or
metastatic NSCLC,
CRC, and other
solid tumors
Phase 1/2 combo with
Cetuximab NA
600mg BID +
cetuximab
400mg/m
2 at the
first day and
250mg/m
2 after
ORR 45.2%
DCR 92.9%
mPFS 7.5 months
mOS not reached
China 2021-12-01
advanced or
metastatic solid
tumors
Phase 1/2
mono or combo
with
pembrolizumab/C
cetuximab/other
NA
150, 300, 600,
800, and 1200 mg
QD, 400, 600, and
800 mg BID
PC: ORR 50.0%,
mPFS 8.54 months,
DCR 80.0%,
TRAE (any grade) 70%,
TRAE (grade 3) 20%
CRC: ORR 20.8%,
DCR 95.8%,
mPFS7.62 months,
TRAE (any grade) 50%,
TRAE (grade ≥3) 2pts
NSCLC: ORR 54.5%,
DCR 81.8%,
TRAE (any grade) 93.8%
US,
Australia,
Korea,
Taiwan
2020-10-14
locally advanced or
metastatic NSCLC Phase 1b/2
combo with
pembrolizumab/c
cetuximab/afatinib
1L
400mg BID or
600mg QD
Pembrolizumab
200mg Q3W,
Afatinib 30mg QD
or QOD,
Cetuximab
400mg/m
2 at the
first day or
250mg/m
2 Q1W,
21-day cycle
- China 2022-07-14
Advanced or
Metastatic Solid
Tumors
Phase 1b/2 Combo with
IN10018 NA 600mg  BID + 100mg
QD Ifebemtinib
NSCLC: mPFS 22.3 months
mDOR 19.4 months
SAE 24.2%
AE (grade≥3) 39.4%
CRC: ORR 44.4%
DCR 100%
mPFS 7.7 months
SAE 11.1%
AE (grade≥3) 27.8%
China 2022-05-18
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Drug Indication Latest
status Company Therapeutic
strategy
Treatment
line
Route of
Administration Treatment Schedules Efficacy & Safety Country
/region
First
posted
date
Krazati
(Adagrasib)
locally advanced or
metastatic NSCLC Approved
BMS
mono 2L+
oral
600mg, BID
ORR 42.9%
mPFS 6.5
months
OS 12.6 months
TRAEs led to
dose reduction
28%, drug
interruption 77%,
permanent
discontinuation
13%
Europe, US
2022-12-12
(FDA)
2024-01-05
(EMA)
locally advanced or
metastatic CRC Approved combo with
cetuximab 2L
ORR 34%
DCR 85.1%
mPFS 6.9
months
mOS 15.9
months
TRAEs led to
dose reduction
35%, drug
interruption 62%,
permanent
discontinuation 2
patients (about
0.02%)
US 2024-06-21
(FDA)
locally advanced or
metastatic non-sq
NSCLC
Phase 3 1L Specified dose on
specified days - Global 2025-03-13
NSCLC Phase 3 Combination with
pembrolizumab 1L
Krazati 400mg BID
+ pembrolizumab
200mg Q3W
- China 2024-03-27
Advanced NSCLC Phase 2/3
Mono or combo
 with
pembrolizumab
1L
Krazati 400mg BID
+ pembrolizumab
200mg Q3W or
Krazati 600mg BID
or Pembrolizumab
200mg Q3W
ORR 44.3%,
mDOR 26.3 months,
mPFS 11.0
months, mOS
18.3 months,
TRAE 94.6%,
TRAE (grade
3/4) 68.4%
US, Europe,
Canada, etc 2020-11-03
Advanced solid
tumors Phase 1/2
Mono or
combination
therapy
NA
Krazati QD or BID
± pembrolizumab
Q3W ± cetuximab
Q2W ± Afatinib
CRC: ORR 43%
DCR 86%,
mPFS 6.9
months, mOS 16
months, TRAE
(grade 3/4) 28%,
TRAE
(discontinuation)
10%
NSCLC: ORR
30.3%, mPFS
4.8 months,
mOS 12.3
months, TRAE
(dose reduction)
51.4%, TRAE
(discontinuation)
5.7%
Puerto Rico,
US 2018-12-24
2023-05-03
2022-01-05
2020-04-01
2025-01-08
Advanced solid
tumors/NSCLC
Phase 1
Combo with
nab-sirolimus NA
Dose escalation of
Krazati and nab-
Sirolimus
-U S
Advanced solid tumors
malignancies with
KRAS G12C
mutation
Combo with
palbociclib NA
Dose escalation of
Krazati and
palbociclib
-U S
Advanced solid
tumors
Combo with
TNO155 NA Krazati 600mg BID
+ TNO155 -U S
Advanced NSCLC
and CRC
Combo with
BMS-986488 NA Specified dose on
specified days
US, Canada,
Australia
combo with
Pembrolizumab +
Chemotherapy
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Lumakras
(Sotorasib)
locally advanced or
metastatic NSCLC Approved
Amgen
mono 2L+
oral
960mg, QD
ORR 37.1%
DCR 80.6%
mPFS 6.3
months
mOS 12.5
months
SAE 14.0%,
TRAEs led to
dose reduction
5%, drug
interruption 34%,
permanent
discontinuation
9%
Europe, US,
Japan
2021-05-28
(FDA)
2022-01-06
(EMA)
2022-01-20
(PMDA)
metastatic CRC
Phase 3
Combo with
Panitumumab and
FOLFIRI
1L
Lumakras QD ±
Panitumumab
and FOLFITI
Q2W
ORR 78%
DCR 95%
mOS 1.5 months
grade ≥ 3 TRAEs 58%
US,
Argentina,
Australia,
Korea, etc
2024-02-12
Stage IV or advanced
stage IIIB/C non-sq
NSCLC
Combo with platinum
doublet 1L
Lumakras 960mg
QD + carboplatin
and pemetrexed
ORR 88.9%
mPFS 6.6 months
mOS 20.6 months
grade ≥ 3
TRAEs 90%
US, Europe,
Japan, etc 2023-06-27
metastatic CRC Combo with
panitumumab 2L+
Lumakras
960/240mg QD
+ panitumumab
Lumakras
960mg: ORR
30.2%, DCR
71.7%, mPFS
5.8 months
Lumakras
240mg: mOS
11.9 months,
ORR 7.5%, DCR
69.8%, mPFS
4.0 months
US, Spain,
Korea, etc 2022-01-20
Drug Indication Latest
status Company Therapeutic
strategy
Treatment
line
Route of
Administration Treatment Schedules Efficacy & Safety Country
/region
First
posted
date
Advanced PC Phase 2 combo with chemo 1L lumakras 960mg
QD ± chemotherapy – Spain, France 2025-03-18
Advanced solid
tumors, advanced
NSCLC
Phase 1/2 Mono and combined
therapy NA Lumakras 960mg
QD ± chemotherapy
NSCLC: mPFS
5.6 months, mOS
11.6 months,
ORR 33.6%,
TRAE (grade 3/4)
26.8%
PC: ORR 21.1%,
DCR 84.2%,
mPFS 3.98
months, mOS
6.87 months
CRC: ORR 9.7%,
TRAE (grade 3)
10%
US, Europe,
Japan, etc 2018-07-26
Advanced solid
tumors with KRAS
p.G12C mutation
Phase 1
Mono or combo with
other anti-cancer
therapies
NA
Lumakras 960mg
QD ± panitumumab
6mg/kg Q2W ±
FOLFIRI ± other
anti-cancer drugs
CRC: ORR 75%,
DCR 95%
NSCLC: mPFS
5.6 months, mOS
11.6 months,
ORR 33.6%,
TRAE (grade 3/4)
26.8%
US, Europe,
Australia, etc 2019-12-04
INDUSTRY OVERVIEW
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--- page 178 ---
Glecirasib
(JAB-
21822)
advanced or
metastatic NSCLC Approved
Jacobio/Allist
Mono 2L+
oral
800mg QD
cORR 49.6%
DCR 86.3%
mPFS 8.2
months
mDOR 14.5
months
mOS 17.5
months
China 2025-05-20
(NMPA)
Locally advanced or
metastatic NSCLC Phase 3 Combo with
JAB-3312 1L JAB-21822+JAB-
3312, 21-days cycle
ORR 64.7%,
mPFS 12.2
months
China 2024-05-16
Locally advanced or
metastatic PC Phase 2 mono 2L+ 800mg QD – China 2023-08-18
advanced CRC,
small intestinal
cancer, appendiceal
cancer
Phase 1b/2 combo with
cetuximab NA
JAB-21822+
cetuximab 21-days
cycle
With cetuximab
group: mDOR 5.1
months, mPFS
6.1 months, mOS
19.3 months,
ORR 50%, DCR
87%, TRAEs (all
grade) 97.7%,
Grade 3-4
TRAEs 19.1%
China 2022-01-19
advanced  solid
tumors Phase 1/2 mono NA QD, 21-days cycle
PDAC: ORR
46.4%, DCR
96.4%, mDoR
4.1 months,
mPFS 5.5
months
China 2021-06-29
JMKX0018
99
advanced or
metastatic NSCLC NDA Jemincare Mono 2L+ oral JMKX001899
500mg QD
DCR 87.6%
ORR 52.4%
mPFS 7.2 months
All TRAE 95.2%
grade ≥ 3
TRAEs 40%
ORR 71%
AE 96%
TRAE 79%
grade 3-4
TRAEs 42%
China 2025-06-05
Drug Indication Latest
status Company Therapeutic
strategy
Treatment
line
Route of
Administration Treatment Schedules Efficacy & Safety Country
/region
First
posted
date
MK-1084
metastatic NSCLC
with confirmed PD-L1
TPS ≥50%
Phase 3
MSD
Combo with
pembrolizumab
1L
oral
MK-1084 QD +
pembrolizumab
200mg on Day 1
of each 21-day
cycle (Q3W) for
up to 35 cycles
US, South
Korea,
Ukraine, Chile
2024-04-03
locally advanced or
metastatic CRC Phase 3 combo with cetuximab,
chemo ± Bevacizumab 1L
MK-1084 QD,
cetuximab Q2W,
chemo Q2W
ORR 58%
DCR 92% Global 2025-05-30
Olomorasib
advanced NSCLC
with confirmed PD-L1
TPS ≥50%
Phase 3
Eli Lilly
Combo with
pembrolizumab
± chemotherapy
1L
oral
olomorasib 50mg
or 100mg BID +
pembrolizumab
plus
ORR 90%
DCR 95%
PFS(12-month)
59.8%
China, US,
Europe, etc 2023-11-07
NSCLC Phase 3 Combo with
pembrolizumab
or Durvalumab
adjuvant
Olomorasib +
Pembrolizumab
up to 1 year
followed by
olomorasib
alone for up to 3
years
– Global 2025-03-24
Divarasib
(RG6330)
advanced or
metastatic NSCLC Phase 3
Roche
Mono 2L+
oral
Divarasib QD China, Korea 2022-10-11
Advanced or
Metastatic non-sq
NSCLC
Phase 3
Combo with
pembrolizumab
± chemotherapy
1L
ORR 55.6%
mDOR 18.0
months
mPFS 13.8
month
TRAE 94%
grade 3-4
TRAE 17%
Divarasib QD +
Pembrolizumab
Q3W ±
chemotherapy
Q3W
ORR 30.0%
TRAE 64.1%
Gr 3 TRAEs
10.3%, no Gr 4-5
TRAEs
– Global 2025-01-27
JDQ443 Locally advanced or
metastatic NSCLC Phase 3 Novartis Mono 2L+ Oral – Global 2021-11-24
Note: Ongoing Clinical trials with first posted date up to Latest Practicable Date, initiated by companies are
included. A blank space in the efficacy and safety column indicates that the results have not been disclosed.
A Phase Ib/III clinical trial is typically designed to investigate the efficacy, safety and clinical benefits of the
test drug(s), with a potentially more streamlined flow to reach the Phase III registrational trial stage, especially
in the context of cancer treatment. Phase Ib/III clinical trial is a two-part trial. The first part is for determining
a recommended Phase 3 dose (RP3D) for the second part, which is a normal Phase 3 clinical trial.
Source: ClinicalTrials.gov, CDE, Frost & Sullivan Analysis
INDUSTRY OVERVIEW
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--- page 179 ---
The selling price of ERBITUX (cetuximab) is approximately US$330.0 for a 20 mL vial
at a concentration of 2 mg/mL in the United States, C339.39 (equivalent to US$367) for a 20
mL vial at a concentration of 5 mg/mL in Germany, and £178.1 (equivalent to US$228) for a
20 mL vial at a concentration of 5 mg/mL in the United Kingdom.
Overview of KRAS G12D Drugs
The KRAS G12D mutation accounts for approximately 29% of all KRAS mutations,
making it the most prevalent variant in human cancers. The KRAS G12D mutation is
particularly frequent in pancreatic cancer (approximately 35%), CRC (approximately 12%) and
NSCLC (approximately 4%). Compared to the KRAS G12C mutation, the KRAS G12D
mutation causes more significant disruption of intrinsic GTPase activity, resulting in a higher
proportion of active GTP-bound KRAS in tumor cells.
With the future commercialization of relevant drug pipelines, the global KRAS G12D
inhibitor drug market is expected to grow from US$81.8 million in 2027 to US$1,204.6 million
in 2033 with a CAGR of 56.6%. The Greater China KRAS G12D inhibitor drug market is
expected to grow from US$12.3 million in 2027 to US$164.0 million in 2033 with a CAGR of
54.0%.
The Global KRAS G12D inhibitor drug market for pancreatic cancer is expected to rose
from US$81.8 million in 2027 to US$1,023.9 million in 2033 with a CAGR of 52.4% during
the period.
The Greater China KRAS G12D inhibitor drug market for pancreatic cancer is expected
to rose from US$12.3 million in 2027 to US$139.4 million in 2033 with a CAGR of 49.9%
during the period.
The diagram below sets forth the projected global market size of KRAS G12D inhibitor
drugs from 2027 to 2033.
Global KRAS G12D Inhibitor Drug Market, 2027E-2033E
12.3 24.1 42.1
68.9 102.4 139.1 164.0 69.5
137.1
241.8
395.6
604.5
856.0
1,040.6
81.8
161.1
283.9
464.5
706.9
995.0
1,204.6
2027E 2028E 2029E 2030E 2031E 2032E 2033E
Greater China ROW
CAGR Greater China Global
2027E -2033E 54.0% 56.6%
Million USD
Source: NMP A, CDE, FDA, ClinicalTrials.gov, Frost & Sullivan Analysis
INDUSTRY OVERVIEW
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--- page 180 ---
The assumptions for the future market forecast of KRAS G12D inhibitor drugs globally
are as follows.
1. Expected first market approval in 2027
We expect that the first KRAS G12D inhibitor drug will be approved for marketing and
generate revenue in 2027, and the indication is likely to be second-line treatment of pancreatic
cancer.
2. Large size of target patient population
The main indications for the clinical development of KRAS G12D inhibitors are
pancreatic cancer, NSCLC, and CRC. It is expected that by 2027, there will be 212.4 thousand,
95.2 thousand, and 258.2 thousand KRAS G12D mutation positive pancreatic cancer, NSCLC,
and CRC patients worldwide, respectively. Over 90% of pancreatic cancer patients are at
advanced or metastatic stage, 90-95% of people receiving first-line treatment, and about
80-85% of patients entering second line treatment. For NSCLC patients, 85-90% of them at
locally advanced or metastatic stage, 90-95% of people receiving first-line treatment, and about
55% of patients entering second line treatment. For CRC patients, the late stage proportion,
first line treatment rate and second line treatment rate are 55-70%, 90-95% and 60-65%
respectively.
3. Growth of penetration rate
Currently, there is no targeted drug for the KRAS G12D mutation. We believe that the
launch of new KRAS G12D inhibitor drugs will quickly penetrate the target patient population,
like the KRAS G12C inhibitor drugs, in light of the market performance of China’s first KRAS
G12C inhibitor after its launch. In the first year of marketing, the approved KRAS G12D
inhibitor drug is expected to be used as a second-line treatment of about 1000 pancreatic cancer
patients, which is equivalent to a penetration rate of about 2% (calculated only for the Chinese
and American pancreatic cancer patients who can accept second-line treatment). By 2033, the
penetration rate is expected to reach about 10% (calculated only for the Chinese and American
pancreatic cancer, NSCLC, CRC patients who can accept second-line treatment).
4. Other growth factors
The expected rapid growth of the future market of KRAS G12D inhibitor drugs is also
based on factors such as the expected increase in the number of approved KRAS G12D
inhibitor drugs, the strong commercialization capabilities of companies with current product
layouts, and the expected expansion of indications of approved KRAS G12D inhibitor drugs.
For example, on August 12, 2025, Bayer and Kumquat Biosciences announced an exclusive
global license and collaboration to develop and commercialize Kumquat’s KRAS G12D
inhibitor. Collaborations between large pharmaceutical corporations and biotechnology firms
have become a mainstream global model and are expected to continue driving the development
of KRAS G12D drug market.
INDUSTRY OVERVIEW
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--- page 181 ---
Competitive Landscape of KRAS G12D Inhibitors
As of the Latest Practicable Date, there was no approved KRAS G12D inhibitor drug
globally. GFH375 is one of the most advanced orally bioavailable inhibitors of KRAS G12D
in terms of development status as of the same date.
The following chart represents comparison of GFH375 with other approved KRAS G12D
inhibitor drugs.
GFH375
Other KRAS G12D
Inhibitor Candidates
MoA /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Targeting both the “on” GTP-
bound and “off’ GDP-bound
states of KRAS protein with
G12D mutation
Mostly targeting “on” GTP-
bound states of KRAS
protein with G12D mutation
Route of
administration /H1118
Oral daily Infusion or oral
Pricing /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Expected to be priced lower
than overseas products
While domestic prices are
expected to be broadly
comparable, overseas
products are generally priced
at higher levels
Safety* /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Special attention should be paid
to the incidence of TRAEs of
grade /H113503
Safety profile is similar among
the products with disclosed
clinical data, subject to
further clinical confirmation
Efficacy* /H1118/H1118/H1118/H1118/H1118/H1118Superior efficacy profile in
PDAC and comparable or
superior efficacy profile in
NSCLC
Products with comparable data
for NSCLC treatment
Note:
* Based on the published clinical trial data, not head-to-head clinical trials.
There were 17 KRAS G12D inhibitor candidates being clinically developed globally as
of Latest Practicable Date. The following table sets forth the clinical-stage KRAS G12D
inhibitor candidates globally.
INDUSTRY OVERVIEW
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--- page 182 ---
Pipeline of Clinical-stage KRAS G12D Inhibitor Candidates Globally
Drug Indication Latest
status Company Therapeutic
strategy
Treatment
Line
Route of
Administration
Treatment
Schedules
Efficacy &
Safety
Country/
region
First posted
date
AZD0022 Advanced solid tumors, NSCLC,
PDAC, CRC Phase 1/2a AZ Mono or combo with
Cetuximab 2L+ oral
AZD0022 ±
cetuximab at the
assigned dose level,
dose level not
disclosed
– US, China 2024-09-19
DN022150 Advanced solid tumors Phase 1/2a DE NOVO Mono 2L+ Infusion 20/50/100/200/300 mg
QW/Q2W/Q3W – China 2024-08-02
RNK08954 Advanced solid tumors Phase 1/2 Ranok
Therapeutics Mono 2L+ oral RNK08954 QD,
21-day cycle – US, China 2024-10-08
GDC-7035 Advanced or metastatic solid
tumors Phase 1/2 Genentech Mono or combo with
other drugs NA NA
administered at the
assigned dose level,
dose level not
disclosed
– NA 2024-10-01
GFH375/
VS-7375
Metastatic pancreatic cancer Phase 2
GenFleet/
Verastem
Mono 2L+
oral
administered at the
assigned dose level,
dose level not
disclosed
– China 2025-05-30
Advanced solid tumors Phase 1/2 Mono NA
GFH375
100/200/400/600/
750/900 mg QD
and 300mg BID
All pts: ORR
38%, DCR 90%,
TRAE (grade ≥3)
29%, SAE 15.6%,
TEAE
(interruption)
21% PDAC: ORR
52%, DCR 100%
NSCLC: ) RR 42%,
DCR 83%
China 2024-07-01
Advanced solid tumors Phase 1/2a Mono NA
administered at the
assigned dose level,
dose level not
disclosed
– US 2025-06-13
HRS-4642
PDAC Phase 2
HengRui
Combo with
chemotherapy NA
Infusion
administered at the
assigned dose level,
dose level not
disclosed
–
China
2024-09-19
Advanced solid tumors
Phase 1/2
Combo with
Adebrelimab or
 SHR-A1921
NA
HRS-4642 +
Adebrelimab/SHR-
9839/HRS-4642,
dose level not
disclosed
– 2024-04-26
Phase 1 Mono NA
15/50/100/200/300
mg QW, 21-day
cycle
NSCLC: DCR
90.0%
All patients: DCR
77.8%, TRAE
(grade ≥3) 33.3%
2022-09-06
TSN1611 Advanced solid tumors Phase 1/2 Tyligand Mono 1L+ oral
administered at the
assigned dose level,
dose level not
disclosed
ORR 25%, DCR
67%
(600-800mg,
BID)
US 2024-04-26
HRS-6093 Advanced solid tumors Phase 1 HengRui Mono 2L+ oral
50mg/150mg
one time
treatment
China 2025-08-21
HBW-012336 Advanced solid tumors Phase 1/2 Hyperway Mono 2L+ oral
administered at the
assigned dose level,
dose level not
disclosed
– China 2025-06-18
HS-10529 Advanced solid tumors Phase 1 Hansoh Mono NA oral HS-10529, 21-day
cycle – China 2023-05-06
LY3962673 Advanced solid tumors Phase 1 Eli Lilly
Mono or combo with
Cetuximab and
chemotherapy
2L+ oral
LY3962673 ±
chemotherapy at the
assigned dose level,
dose level not
disclosed
– US 2024-9-19
QTX3046 Advanced solid
tumors Phase 1 Quanta
Therapeutics
Mono, or
combo with
cetuximab
2L+ oral
QTX3046 ±
cetuximab, dose
level not
disclosed
– US 2024-05-24
QLC1101
Unresectable or
metastatic solid
tumors
Phase 1/2b
Combo
with
QL1203/QL2107/
QL1706/
docetaxel
NA
QLC1101
600-1200mg BID,
14-day cycle
– 2025-05-21
Advanced solid
tumors Phase 1
Qilu
Pharmaceutical
Mono 1L+
oral
QLC1101 BID,
21-day cycle – China
China
2024-05-08
AST2169 Advanced solid
tumors Phase 1 Allist
Pharmaceuticals Mono 1L+ Infusion
42/150/300/400/
500/600 mg at the
1, 8 and 15 day of
one 21-day cycle
– China 2024-04-02
INCB161734
Advanced or
metastatic solid
tumors
Phase 1
Incyte
Corporation
Mono, or
combo with
other anti-cancer
therapies
1L+ oral
INCB161734 ±
protocol-defined
dose strength
based on cohort
assignment
–
Australia,
US,
Belgium,
Canada,
France,
Italy, Spain
2023-12-21
INCB186748
 Advanced or
Metastatic Solid
Tumors, PDAC, CRC
Phase 1
Combo with
cetuximab/
GEMNabP/
mFOLFIRINOX
2L+ NA
administered at the
assigned dose level,
dose level not
disclosed
– US 2025-02-10
RMC-9805 Advanced solid
tumors Phase 1 Revolution
Medicines
Mono, and
combo with
RMC-6236
2L+ oral 600 mg BID or
1200 mg QD
NSCLC: ORR
61%, DCR 89% US 2023-09-15
Note: Ongoing Clinical trials with first posted date up to Latest Practicable Date, initiated by companies are
included.
Source: CDE, ClinicalTrials.gov, Frost & Sullivan Analysis
INDUSTRY OVERVIEW
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--- page 183 ---
Overview of Pan-RAS Drugs
RAS proteins are frequently mutated proto-oncogenes in human cancers, which are
encoded by three commonly expressed genes: HRAS, KRAS, and NRAS. Three RAS oncogene
mutations are present in approximately 30% of all human cancers, and they drive tumor growth
and metastasis through aberrant activation of RAS-mediated signaling.
Percentage Distribution of RAS Isoforms
Contributing to Cancer
KRAS NRAS HRAS
75%
7%
17%
KRAS mutations are detected in approximately 90% of pancreatic cancer, 30-40% of
CRC, and 15-20% of lung cancer patients. According to the U.S. data, the five most common
KRAS mutant isoforms, KRAS G12D (29%), G12V (23%), G12C (15%), G13D (7%), and
G12R (5%), collectively accounted for about 80% of all KRAS alterations. According to a
landscape analysis of Chinese tumor samples, KRAS G12C accounted for 14.5% of all KRAS
mutations. The top three cancers with the highest KRAS mutation rates are pancreatic cancer,
NSCLC, and CRC. The percentages of incidence of different types of KRAS mutation in these
cancers are shown below.
NSCLC CRC
G12D G12V G12C G12R G13D Others
41.0%39.7%
31.7%
17.8%
10.8%
27.6%34.5%
20.0%
18.0%
28.5%
11.1%
19.4%
Pancreatic Cancer
INDUSTRY OVERVIEW
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--- page 184 ---
The prevalence of different types of KRAS mutations in cancer patients vary by ethnicity.
The incidence of KRAS mutations is different between the East and the West. KRAS mutations
are found in approximately 20%–25% of lung cancer cases in the Western countries and
10%–15% of lung cancer cases in Asian countries. There are at least nine different KRAS
mutational subtypes. Among the subtypes of KRAS mutations, KRAS G12C is the subtype
most often found in the West. The patterns reported in Asia are somewhat different: whereas
some studies similarly report G12C as the most common subtype, others report that G12D is
most often identified. GFH925 targets the G12C mutation, whereas GFH375 targets the G12D
mutation. The varying prevalence of the two types of KRAS mutation affect the size of
potential markets for KRAS G12C and G12D inhibitor drugs at different geographical
locations.
Pan-RAS inhibitors are theoretically advantageous over mutation-specific products in
addressing a broader range of oncogenic RAS mutants and wild-type RAS isoforms.
Pan-targeting approaches have the potential to block compensatory activation of wild-type
RAS proteins and prevent the emergence of acquired resistance to mutant-specific inhibitors.
Pan-RAS may also have potentially broad applications and long-lasting therapeutic benefits
across various cancer types. Drug candidates that dampen excessive activities of RAS proteins
in a pan-RAS manner could potentially enable sequential therapies to overcome resistance to
mutant-specific treatments.
Pan-RAS inhibitors, regardless of the specific mutation sites of RAS oncogenes, act as
multi-selective, triple-complex inhibitors designed to comprehensively block RAS proteins.
Pan-RAS inhibitors can be categorized as direct-binding and indirect-binding pan-RAS
inhibitors. Direct-binding inhibitors target common binding sites across all RAS isozymes,
allowing them to suppress the entire RAS signaling network, independent of any specific
isozyme or mutation. Indirect-binding inhibitors function by targeting RAS-interacting
proteins, thereby inhibiting RAS protein-protein interactions and reducing RAS signaling.
Examples of indirect-binding inhibitors include inhibitors that block RAS-activating proteins
to suppress RAS activity. In addition, innovative modalities, such as functional antibody-
molecular drug conjugates, are also being explored to achieve pan-RAS signaling inhibition.
On the other hand, available clinical results suggest that some pan-RAS inhibitors may be
associated with adverse effects that are related to their comprehensive blockage of RAS
proteins. Therefore, pan-RAS inhibitor drug candidates with improved safety profiles may
have enhanced therapeutic potentials.
Pan-RAS approaches are differentiated from pan-KRAS approaches that aim to address
multiple KRAS mutations at the same time. Pan-KRAS “off” state inhibitors are vulnerable to
adaptive resistance caused by mitogen-activated protein kinase (“ MAPK ”) reactivation via
upstream receptor tyrosine kinase signaling. Moreover, pan-KRAS “off” state inhibitors have
been found ineffective against certain KRAS mutants, such as KRAS G12R or KRAS Q61X,
which exhibit nearly complete impairment of GTPase activity in tumor cells. Therefore, a
pan-RAS “on” state inhibitor would potentially encompass a larger patient population and yield
better clinical outcomes compared to existing pan-KRAS “off” state inhibitors.
Competitive Landscape of Pan-RAS Drugs
As of the Latest Practicable Date, there was no approved pan-RAS drug worldwide. There
were six pan-RAS and 15 pan-KRAS inhibitor candidates being clinically developed globally
as of Latest Practicable Date. The following table sets forth the clinical-stage pan-RAS
inhibitor and pan-KRAS inhibitor candidates globally.
INDUSTRY OVERVIEW
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--- page 185 ---
Pipeline of Clinical-stage Pan-RAS Inhibitor Drug Candidates Globally
Drug Indication Latest
status Company Therapeutic
strategy
Treatment
Line
Route of
Administration Treatment Schedules Efficacy
& Safety
Country/
region
First
posted
date
RMC-6236
metastatic
PDAC Phase 3
Revolution
Medicines
mono 2L+
oral
administered at the
assigned dose level, dose
level not disclosed
–
US,
Europe,
Japan,
Puerto Rico
2024-10-03
Locally
Advanced or
Metastatic RAS
mutant NSCLC
Phase 3 mono 2L+
administered at the
assigned dose level, dose
level not disclosed
– US,
Puerto Rico 2025-03-18
Gastrointestinal
solid tumors Phase 1/2
combo with
SOC or novel
agents
NA
RMC-6236 + 5-fluorouracil-
based regimens
RMC-6236 + cetuximab with
or without mFOLFOX6
RMC-6236 + gemcitabine +
nab-paclitaxel
RMC-9805 with or without
RMC-6236 + 5-fluorouracil-
based regimens
RMC-9805 with or without
RMC-6236 + cetuximab with
or without mFOLFOX6
RMC-9805 with or without
RMC-6236 + gemcitabine +
nab-paclitaxel
– US,
Europe 2024-06-06
RAS-mutated
NSCLC Phase 1/2
Combo with
pembrolizumab,
with or without
chemotherapy
2L+
RMC-6291 BID/RMC-9805
QD or BID ± RMC-6236 QD
+ pembrolizumab Q3W ±
chemotherapy (Q3W-Q4W)
– US,
Europe 2023-12-08
Advanced
KRAS G12C
Mutant Solid
Tumors
Phase 1
Combo with
RMC-6291 2L+
RMC-6291 + RMC-6236
administered at the
assigned dose level, dose
level not disclosed
–
US,
Europe,
Puerto Rico
2023-11-13
INDUSTRY OVERVIEW
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--- page 186 ---
Drug Indication Latest
status Company Therapeutic
strategy
Treatment
Line
Route of
Administration Treatment Schedules Efficacy
& Safety
Country/
region
First
posted
date
RMC-6236
RAS mutant
advanced solid
tumors
Phase 1 Mono 2L+ oral
doses ranging
from 160mg to
300mg QD
KRAS G12X
mutation in
the PDAC 2L
treatment (300mg
daily): mPFS 8.8
months, OS 100%
KRAS G12X
mutation in the
NSCLC 2L
treatment
(120-220mg daily):
mPFS 9.8 months,
mOS 17.7 months
any RAS mutation
in the 2L treatment
(300mg daily): mPFS
8.5 months, OS 97%
US 2022-05-18
JYP0015/E
RAS-0015
RAS mutant
advanced solid
tumors
Phase 1/2
JOYO
Pharma/
Erasca
Mono NA
oral
4/8/16mg QD,
21-day cycle,
4 cycles
– China 2025-03-07
RAS mutant
advanced or
metastatic solid
tumors
Phase 1
Mono or in
combination
with
pembrolizumab
or panitumumab
NA NA – US 2025-05-21
LUNA18
Locally
Advanced or
Metastatic
Solid Tumors
Phase 1 Chugai
Pharma
Mono or in
combination
with other
anti-cancer
drugs
NA oral
LUNA18 ±
cetuximab
administered at
the assigned
dose level, dose
level not
disclosed
– US,
Japan
2021-08-19
INDUSTRY OVERVIEW
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--- page 187 ---
Drug Indication Latest
status Company Therapeutic
strategy
Treatment
Line
Route of
Administration Treatment Schedules Efficacy
& Safety
Country/
region
First
posted
date
RO7673396 Advanced solid
tumors with
RAS mutation
Phase 1 Roche Mono NA NA
administered at the
assigned dose
level, dose level not
disclosed
–
Australia,
New
Zealand
2025-03-19
VVD-159642 Advanced solid
tumors, PDAC,
CRC, NSCLC
Phase 1 Vividion
Therapeutics
Mono or
combination
with
sotorasib/
trametinib
NA oral
administered at the
assigned dose
level, dose level not
disclosed
– US,
Australia 2025-02-03
HRS-7172
Advanced solid
tumors with
RAS mutation
Phase 1 HengRui Mono NA NA
administered at the
assigned dose level,
dose level not
disclosed
– China 2025-08-21
Note: Ongoing Clinical trials with first posted date up to Latest Practicable Date, initiated by companies are included.
Source: CDE, ClinicalTrials.gov, Frost & Sullivan Analysis
INDUSTRY OVERVIEW
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Pipeline of Clinical-stage Pan-KRAS Inhibitor Drug Candidates Globally
Drug Indication Latest
status Company Therapeutic
strategy Treatment Line Route of
Administration Treatment Schedules Efficacy
& Safety
Country/
region
First
posted
date
PF-07985045
advanced
solid tumors,
NSCLC,
CRC, PDAC
Phase 1
Pfizer
mono or combo
with other
anti-cancer
therapies
part I: 2-3L
part II: PDAC
1L, CRC 1L+,
NSCLC 1L
oral
PF-07985045
administered at the
assigned dose level ±
cetuximab/
pembrolizumab/
sasanlimab/SHP2 ±
chemotherapy,
21/28-day cycle
–
US,
Japan,
Puerto
Rico
2024-11-26
PF-07934040
Advanced
Solid Tumors
Harboring
Mutations in
the KRAS
Gene
Phase 1
Combo with
other Targeted
Agents
part I: 2-3L
part II: PDAC
1L, CRC 1L+,
NSCLC 1L
oral
PF-07934040
administered at the
assigned dose level ±
cetuximab/
pembrolizumab/
sasanlimab/SHP2 ±
chemotherapy,
21/28-day cycle
–
China,
US,
Puerto
Rico
2024-06-07
QTX3544 advanced
solid tumors Phase 1
Quanta
Therapeutics
mono or
combo with
cetuximab
2L+ oral
QTX3544 administered
at the assigned dose
level ± cetuximab
–U S 2024-12-04
QTX3034
Solid tumors
with
KRASG12D
mutation
Phase 1
Mono, or
combined with
cetuximab
2L+ oral
QTX3034 administered
at the assigned
dose level ± cetuximab
– US 2024-01-26
INDUSTRY OVERVIEW
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--- page 189 ---
JAB-23E73 advanced
solid tumors Phase 1/2a Jacobio mono NA oral 5/10/40mg QD,
21-day cycle – China,
US 2024-11-11
LY4066434
locally
advanced or
metastatic solid
tumors
Phase 1 Eli Lilly
mono or
combo with
other
treatments
NA oral
LY4066434
administered at the
assigned dose
level ± cetuximab
± chemotheraphy
–
China,
US,
Belgium,
Japan,
Spain,
Taiwan
2024-09-23
BGB-53038
advanced or
metastatic solid
tumors
Phase 1 BeiGene
mono or
combo with
tislelizumab
NA oral
BGB-53038
administered at the
assigned dose
level ± Tislelizumab
and cetuximab
–
China,
US,
Australia,
Korea,
New
Zealand,
Spain
2024-09-05
YL-17231 Advanced solid
tumors Phase 1 Yingli
Pharmaceutical Mono
NSCLC:
2L
CRC: 3L
others:
2L+
oral 0.25-10mg BID,
21-day cycle – China 2023-10-12
BI 3706674
Unresectable
Metastatic
KRAS Wild
Type Amplified
GAC, EAC and
AGEJ
Phase 1
Boehringer
Ingelheim
Mono NA oral
administered at the
assigned dose
level, dose level
not disclosed
–
US,
Japan,
Korea,
Taiwan
2023-09-28
BI 1701963
KRAS Mutated
Advanced or
Metastatic Solid
Tumours
Phase 1
Mono and and
Combined
With
Trametinib
2L+ oral
BI 1701963
50/100/200/400/
800 mg, QD ±
Trametinib
TRAE
64%
Germany,
Nether-
lands,
US
2019-10-01
Drug Indication Latest
status Company Therapeutic
strategy Treatment Line Route of
Administration Treatment Schedules Efficacy
& Safety
Country/
region
First
posted
date
INDUSTRY OVERVIEW
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--- page 190 ---
Drug Indication Latest
status Company Therapeutic
strategy Treatment Line Route of
Administration Treatment Schedules Efficacy
& Safety
Country/
region
First
posted
date
BBO-11818
locally
advanced and
unresectable
or metastatic
NSCLC,
PDAC, CRC,
 or other solid
tumor with
KRAS mutation
Phase 1
TheRas/
BridgeBio
Oncology
Therapeutics
Mono and
combined with
pembrolizumab,
pembrolizumab +/-
cis/carboplatin +
pemetrexed, or
cetuximab
NA oral
administered
at the
assigned dose
level, dose
level not
disclosed
– US 2025-04-08
ALTA-3263
Advanced solid
tumors with
KRAS
mutations,
PDAC,
NSCLC, CRC
Phase 1 Alterome
Therapeutics Mono NA oral
administered
at the
assigned dose
level, dose
level not
disclosed
– US 2025-02-19
ERAS-4001
Advanced
Solid
Tumors
Phase 1 Erasca
Mono and
combined with
pembrolizumab/
panitumumab
NA oral
administered
at the
assigned dose
level, dose
level not
disclosed
– NA 2025-06-15
KQB-365
Advanced Solid
Tumors with
either a KRAS
G12C or
KRAS G12S
mutation
Phase 1 Kumquat
Biosciences
mono or combined
with cetuximab NA Intravenous
administered
at the
assigned dose
level, dose
level not
disclosed
– US 2024-12-06
AMG-410
KRAS-altered
advanced or
metastatic solid
tumors
Phase 1 Amgen
mono or
combined with
Pembrolizumab or
Panitumumab
NA oral
administered
at the
assigned dose
level, dose
level not
disclosed
– US,
Australia 2025-07-30
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--- page 191 ---
Note: Ongoing Clinical trials with first posted date up to Latest Practicable Date, initiated by companies are included.
Source: CDE, ClinicalTrials.gov, Frost & Sullivan Analysis
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Entry Barriers of RAS Drug Market
There are considerable entry barriers for the development of RAS drugs:
 Challenging Druggability. RAS proteins have been well-established to be
challenging drug targets. Primarily, it is difficult to design selective RAS inhibitors
because of the unique smooth surface of RAS proteins. Additionally, the high
affinity for GTP/GDP of RAS proteins and the absence of known allosteric
regulatory sites also make it difficult to develop targeted therapies. Furthermore, not
only it is difficult to identify effective therapeutics for each mutant RAS protein, it
is also challenging to enhance their ability to selectively inhibit mutated RAS
proteins in order to reduce toxicity and side effects. These factors combined pose
considerable challenges to the development of RAS-targeted drugs.
 Considerable Development Uncertainty . In the past, the successful rate of
conducting preclinical and/or clinical studies of RAS-targeted drugs was relatively
low, mainly due to unsatisfying efficacy and/or inherited toxicity. The high risk of
development failure has discouraged pharmaceutical companies from investing in
this particular domain. Moreover, since RAS mutations are present in a wide range
of cancers, the response to RAS-targeted therapies can vary significantly across
different patient populations, which further increases the uncertainty of developing
RAS-targeted drugs.
 Significant R&D Cost . Developing RAS inhibitors requires extensive preclinical
studies to understand their effects on multiple signaling pathways and to optimize
drug candidates for potency and selectivity. For instance, the mechanism of RAS
drugs resistance is complex, including primary resistance, acquired resistance due to
mutation escape, and adaptive resistance, all of which require considerable research
efforts. The monetary and time investment required for these studies are significant
and could be an entry barrier especially for emerging pharmaceutical companies.
Growth Drivers and Future Trends of RAS Drug Market
According to Frost & Sullivan, the RAS drug market growth has primarily been driven
by the following factors:
 Development Beyond KRAS Targets. As of the Latest Practicable Date, all
RAS-targeted drugs approved globally were KRAS G12C inhibitors. Nonetheless,
ongoing research has expanded to additional KRAS mutations, such as G12D, G12V
and G13D, as well as NRAS and HRAS mutations, thereby broadening therapeutic
options across a wider range of cancers. A key area of interest is the development
of pan-RAS inhibitors, which target multiple RAS isoforms or mutations
simultaneously. These inhibitors are designed to treat a broader spectrum of
RAS-driven cancers by inhibiting various RAS variants and to overcome the
limitations of mutation-specific therapies.
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--- page 193 ---
 Exploration of Combination Therapies . A promising trend in cancer treatment is the
development of combination therapies that integrate RAS inhibitors with other
targeted agents, immunotherapies, or chemotherapy. These combinations aim to
improve treatment efficacy, minimize the emergence of drug resistance, and
effectively address the complexities of cancer signaling pathways.
 Extending the Breadth of RAS Inhibitors . Recent research has focused on designing
novel modalities, including bioconjugates, RAS degraders, toxins, immunotherapy,
and siRNA-based approaches, each offering distinct advantages. For instance,
FAScon, a class of bioconjugates featuring a combination of antibody and small
molecule drug targeting separate components of the same signaling pathway, has the
potential to realize both precise targeting and synergistic effects of the large and
small molecules, and to prevent premature release of payload in the blood and
enables conjugation of hydrophobic small molecules at a high drug-to-antibody
ratio.
The Company stays at the forefront of the industry by expanding its RAS pipelines,
developing various combination therapies and exploring novel modalities.
Major Indications of RAS Inhibitors
NSCLC
NSCLC is any type of epithelial lung cancer other than small cell lung cancer (SCLC),
which accounts for approximately 85% of all lung cancer incidence. The three main subtypes
of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma. All types
can occur in unusual histologic variants and develop as mixed cell-type combinations. The
subtypes of NSCLC can be categorized based on the presence or absence of driver gene
mutations. Among the common driver genes identified in NSCLC, KRAS mutations are one of
the most prevalent mutations, accounting for approximately 20% of cases, and KRAS G12C
mutation alone is present in approximately 13% of all NSCLC cases. The following table sets
forth the percentages of NSCLC incidence with different oncogene mutations.
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Percentages of NSCLC Incidence with Oncogenes Mutations
Gene Mutation Percentage
EGFR mutation 45-50% (Asian), ~20% (Western Countries)
ALK fusion 3-5%
ROS1 fusion ~2%
BRAF V600E 1-2%
NTRK fusion Less than 1%
KRAS G12C mutation ~4% (Asian),  ~13% (Western Countries)
MET14 exon skipping mutation ~3%
RET fusion 1-2%
ERBB2 mutation 1-6%
Source: Literature review, Frost & Sullivan Analysis
The global incidence of NSCLC increased from 1,937.6 thousand in 2019 to 2,203.5
thousand in 2024, and is expected to further increase to 2,761.6 thousand in 2033. In China,
the incidence of NSCLC increased from 830.2 thousand in 2019 to 946.7 thousand in 2024, and
is expected to further increase to 1,119.3 thousand in 2033. The diagram below sets forth the
historical and projected incidence of NSCLC from 2019 to 2033.
Global and China Incidence of NSCLC, 2019-2033E
2019 2020 2021 2022 2023 2024 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E
Period CAGR
ROWChina Global
2019-2024 2.7% 2.6% 2.6%
2024-2033E 1.9% 3.0% 2.5%
Thousand
901.6
China ROW
830.2 852.8 876.6 901.6 926.6 946.7 966.2 984.2 1,002.5 1,021.2 1,040.1 1,059.4 1,079.0 1,099.0 1,119.3
1,107.5 1,138.9 1,172.0 1,207.0 1,229.7 1,256.8 1,288.8 1,332.8 1,376.9 1,421.2 1,465.5 1,509.9 1,554.1 1,598.3 1,642.3
1,937.6 1,991.7 2,048.6 2,108.6 2,156.3 2,203.5 2,255.1 2,317.0 2,379.5 2,442.4 2,505.7 2,569.3 2,633.2 2,697.3 2,761.6
Source: WHO, NCC, IARC, Frost & Sullivan Analysis
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NSCLC treatment options mainly depend on the disease stage and specific gene mutation.
The following charts set forth the treatment regimen of advanced NSCLC (stage IV with
metastasis) according to NCCN 2025 and CSCO 2024, respectively.
Treatment Paradigm of Advanced NSCLC in U.S. (NCCN 2025)
Advanced NSCLC
EGFR
mutation
positive
ALK fusion-
positive
ROS1 fusion-
positive
• Alectinib
 Brigatinib
 Lorlatinib
 Crizotinib
 Ceritinib
 Ensartinib
 Entrectinib
 Crizotinib
 Repotrectinib
definitive local
therapy for
limited lesions
 Continue
alectinib/
brigatinib/
ceritinib/
lorlatinib/
Ensartinib
 Lorlatinib (if not
previously given
 Systemic therapy
 Consider
definitive local
therapy for
limited lesions
 Continue
entrectinib,
crizotinib ,
repotrectinib
 Repotrectinib/
lorlatinib/
Entrectinib
 Systemic
therapy
 Consider  Consider
definitive local
therapy for limited
lesions
 Continue
Osimertinib/
erlotinib/afatinib/
gefitinib/
dacomitinib
 Amivantamab -
vmjw +
carboplatin +
pemetrexed
 Systemic therapy Patients with disease
progression on EGFR TKI
therapy: Afatinib + cetuximab
 PD-1/PD-L1 inhibitor
monotherapy is less effective,
irrespective of PD-L1 expression,
in EGFR exon 19 deletion or exon
21 L858R, ALK+ NSCLC
 Capmatinib
 Tepotinib
 Crizotinib
 Systemic
Therapy
 Fam -
trastuzumab
deruxtecan -
nxki
 Ado-
trastuzumab
emtansine
BRAF V600E
mutation
 Dabrafenib +
trametinib
 Encorafenib
+ binimetinib
 Vemurafenib
 Dabrafenib
 Systemic
therapy
 Larotrectinib
 Entrectinib
 Systemic
Therapy
 Continue first line
treatment
 Systemic Therapy
 Lorlatinib (if not
previously given)
 Systemic
Therapy
Adenocarcinoma
 Squamous Cell
Carcinoma
 Systemic
Therapy
 Systemic
Therapy
 Maintenance
therapy
NTRK fusion
mutation
MET14 exon
skipping
mutation
RET fusion
mutation
ERBB2
mutation
 Selpercatinib
 Pralsetinib
 Systemic
therapy
 Systemic
Therapy
 Capmatinib
 Tepotinib
 Crizotinib
 Selpercatinib
 Pralsetinib
 Cabozantinib
 Systemic
Therapy
Disease
Progression
First
Line
(~92%)
Second
Line
Clinico -
pathological
Stages
Third
Line
Disease
Progression
 Atezolizumab,
Cemiplimab-
rwlc
 Pembrolizumab
 Combination
therapies
KRAS G12C
mutation
 KRAS inhibitor
 Sotorasib
(Lumakras) and
adagrasib
(Krazati)
 Osimertinib +
pemetrexed + (cisplatin/
carboplatin)
 Erlotinib/Afatinib/
Gefitinib/Dacomitinib
 Erlotinib ± ramucirumab/
bevacizumab/Gefitinib
 Amivantamab-vmjw +
carboplatin/pemetrexed
 Osimertinib
/Amivantamab-vmjw +
lazertinibtt
 Zenocutu
zumab-
zbco
 Systemic
Therapy
NRG1
fusion
 Systemic
therapy
Source: NCCN2025v3, Frost & Sullivan Analysis
In summary, for advanced NSCLC patients without specific gene mutations, first-line
treatment mainly includes immunotherapy, chemotherapy, or combination therapy. If there are
targeted gene mutations, targeted drugs (such as osimertinib and alectinib) are preferred as
first-line treatment. The second-line selection of advanced NSCLC patients is mainly adjusted
based on the first-line medication. If immunotherapy is used as first-line treatment,
chemotherapy or targeted drugs (if there are newly discovered mutations) should be switched.
If targeted drugs are used as first-line treatment, another targeted drug should be switched, or
chemotherapy combined with immunotherapy should be used. According to NCCN, for
NSCLC patients with the KRAS G12C mutation, the first-line treatment is PD-(L)1 as a
monotherapy or in combination with chemotherapy, and the second-line treatment is sotorasib
or adagrasib.
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Treatment Paradigm of Advanced NSCLC in China (CSCO 2024)
Advanced NSCLC
EGFR mutation
positive
ALK fusion-
positive
ROS1 fusion-
positive
 Geftinib
 Erlotinib
 Afatinib
 Dacomitinib
 Osimertinib
 Vemurafenib
 Almonertinib
 Befotertinib
 icotinib
 Alectinib
 Brigatinib
 Lorlatinib
 Ensartinib
 Irlotinib
 Ceritinib
 Crizotinib
 Entrectinib
 Crizotinib
 Continuation of original TKI
treatment + local therapy
 Alectinib, ceritinib, ensartinib,
brigatinib, Irlotinib or
lorlatinib
 Second-generation TKI for
first-line treatment or
first/second-generation TKIs
fail: lorlatinib
 After TKI treatment failure:
platinum-based doublet
chemotherapy ± bevacizumab
 Continue
original KTI
treatment +
local therapy
 Platinum-
containing
doublet
chemotherapy ±
bevacizumab
 Continuing the original
EGFR-TKI treatment
alongside local therapy
 Patients who have failed
first/second-generation
TKI treatment and exhibit
T790M mutation
positivity upon re-biopsy:
Osimertinib/
Almonertinib/
Furmonertinib/
Befotertinib
 Patients negative for T790M mutation upon re-
biopsy/have failed third-generation TKI
treatment: platinum-containing doublet
chemotherapy ± bevacizumab
 Patients who have failed targeted therapy and
platinum-containing doublet chemotherapy:
monotherapy chemotherapy
 Gumetinib
 Borretinib
 Tepotinib
 Nivolumab
 Tislelizumab
 Docetaxel
 Pemetrexed
 Best supportive therapy
BRAF V600E
mutation
 Dabrafenib +
Trametinib
 Entrectinib
 Larotrectinib
 Refer to IV-stage non-
driver gene NSCLC in
2L+ treatment
 Patients who have failed
targeted therapy and
platinum-based doublet
chemotherapy:
monotherapy
chemotherapy
 Monotherapy
Chemotherapy
 Nivolumab
 Docetaxel
 Pemetrexed
 Anlotinib
NTRK fusion
mutation
MET14 exon
skipping
mutation
RET fusion
mutation
KRAS G12C/HER2
mutation or
Non-driver gene
 Selpercatinib
 Pralsetinib
 Pembrolizumab
 Atezolizumab
 Pemetrexed + Platinum + ICI
 Pemetrexed + Platinum +
Pemetrexed
 Bevacizumab + Platinum
Doublet Chemotherapy +
Bevacizumab
 Single agent chemotherapy
 Seviteronib
 Gumetinib
 Borretinib
 Tepotinib
 Refer to IV-
stage non-
driver gene
NSCLC in
2L+
treatment
 Selpercatinib
 Pralsetinib
 Refer to IV-
stage non-
driver gene
NSCLC in
2L+ treatment
Disease
Progression
First
Line
(~90%)
Second Line
(~55%)
Clinico-
pathological
Stages
Third
Line
Disease
Progression
Source: CSCO 2024, Frost & Sullivan Analysis
Abbreviations: PCBA=Paclitaxel + Carboplatin + Bevacizumab in combination with Atezolizumab;
PCBT=Paclitaxel + Carboplatin + Bevacizumab combined with Trastuzumab; PCBR=Paclitaxel + carboplatin +
bevacizumab combined with ramucirumab; APCA=Albumin-bound Paclitaxel + Carboplatin in combination with
Atezolizumab; NIP=Nivolumab and Ipilimumab in combination with Pembrolizumab; PP=Pemetrexed in
combination with platinum agents; BP=Bevacizumab in combination with platinum-based doublet chemotherapy;
PC=PD-L1 inhibitors as monotherapy or in combination with chemotherapy
In China, the overall principles for the first-line and second-line treatments for advanced
NSCLC are similar to those in the United States, but there is a gap in the availability of new
targeted drugs. For some disease causing specific gene mutations, there are no marketed drugs
that target these gene mutations. In China, for NSCLC patients with the KRAS G12C mutation
in the 2024 version of the diagnosis and treatment guidelines, the I/II grade recommendations
for first-line and second-line treatments refer to the treatment plan for NSCLC patients without
driver gene mutations (i.e., without gene mutations that promote the development and
progression of the cancer), and the III grade recommendations for second-line treatment are
sotorasib and adagrasib (not yet approved in China).
The KRAS G12C and G12D mutations are among the most common oncogene mutations
in NSCLC incidence. The diagrams below set forth the historical and projected incidences of
G12C and G12D mutated NSCLC from 2019 to 2033, respectively.
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Incidence of KRAS G12C mutated NSCLC, 2019-2033E
2019 2020 2021 2022 2023 2024 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E
China ROW
CAGR China Global
2019-2024 2.7% 2.6%
2024-2033E 1.9% 2.5%
Thousand
35.7 36.7 37.7 38.8 39.8 40.7 41.5 42.3 43.1 43.9 44.7 45.6 46.4 47.3 48.1
216.2 222.2 228.6 235.3 240.5 245.7 251.6 258.9 266.2 273.6 281.0 288.5 295.9 303.4 310.9
251.9 258.9 266.3 274.1 280.3 286.5 293.2 301.2 309.3 317.5 325.7 334.0 342.3 350.7 359.0
Source: IARC, NCCN, Frost & Sullivan Analysis
Incidence of KRAS G12D mutated NSCLC, 2019-2033E
18.3 18.8 19.3 19.8 20.4 20.8 21.3 21.7 22.1 22.5 22.9 23.3 23.7 24.2 24.6
59.2 60.9 62.7 64.5 65.9 67.3 68.9 71.0 73.1 75.2 77.3 79.5 81.6 83.7 85.8
77.5 79.7 81.9 84.3 86.3 88.1 90.2 92.7 95.2 97.7 100.2 102.8 105.3 107.9 110.5
2019 2020 2021 2022 2023 2024 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E
CAGR China Global
2019-2024 2.7% 2.6%
2024-2033E 1.9% 2.5%
Thousand
ROW China
Source: IARC, NCCN, Frost & Sullivan Analysis
The 5-year survival rate for lung cancer in China is comparable to that in the United
States, both standing at approximately 20%, which is significantly lower than that of other
major cancers. The low survival rate is primarily attributed to a lack of early detection tools
and the limited number of early-stage diagnoses. In China, the majority of NSCLC patients are
diagnosed at an advanced stage, with approximately 60% to 70% being diagnosed at Stage IV .
For patients with unresectable locally advanced NSCLC, the prognosis remains poor despite
standardized treatment, which typically involves concurrent radiotherapy. Despite following
these treatment protocols, many patients experience rapid disease progression and unsatisfied
outcomes, leading to a 5-year overall survival rate of only 15% to 25%. The low survival rate
and deficient treatment underscore the critical need for improved therapeutic options.
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There is also a lack of effective targeted therapies for KRAS mutations in NSCLC. About
90% advanced NSCLC patients received first-line treatment, and about 55% of them entered
the second-line treatment in China. Research has shown that KRAS-mutant NSCLC patients in
the past were considered insensitive to chemotherapy and had poor prognoses. The efficacy of
PD-1 combined with chemotherapy has also been reported with mixed results. Additionally,
primary and acquired resistance in EGFR-mutant patients is also associated with KRAS
mutations. In August 2024, GFH925 (fulzerasib) became the first commercially available
KRAS G12C inhibitor drug in China, which offers a novel solution for patients with KRAS
G12C mutations, and potentially addresses the gap in targeted therapies for this mutation.
CRC
CRC, also known as bowel cancer, colon cancer, or rectal cancer, is a type of cancer that
develops from the colon or rectum. Most colorectal cancers develop first as polyps, which are
abnormal growths inside the colon or rectum that may later become cancerous if they are not
removed. KRAS mutations are also prevalent mutations for CRC. RAS is one of the most
frequently mutated oncogenes in CRC, and KRAS G12C mutation alone appears in
approximately 3-4% of the CRC incidence.
The global incidence of CRC increased from 1,849.1 thousand in 2019 to 2,005.2
thousand in 2024, and is expected to further increase to 2,472.6 thousand in 2033. In China,
the incidence of CRC increased from 477.1 thousand in 2019 to 542.4 thousand in 2024, and
is expected to further increase to 642.0 thousand in 2033. The diagram below sets forth the
historical and projected incidence of CRC from 2019 to 2033.
Global and China Incidence of CRC, 2019-2033E
1,849.1 1,880.7 1,928.0 1,926.4 1,966.2 2,005.2 2,048.1 2,099.7 2,151.8 2,204.3 2,257.2 2,310.6 2,364.2 2,418.3 2,472.6
2019 2020 2021 2022 2023 2024 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E
Period CAGR
China ROW Global
2019-2024 2.6% 1.3% 1.6%
2024-2033E 1.9% 2.5% 2.4%
Thousand
China ROW
477.1 489.8 503.1 517.1 531.2 542.4 553.5 564.4 575.3 586.2 597.3 608.4 619.5 630.7 642.0
1,372.0 1,390.9 1,424.9 1,409.3 1,435.0 1,462.8 1,494.6 1,535.3 1,576.5 1,618.0 1,659.9 1,702.2 1,744.7 1,787.5 1,830.6
Source: WHO, IARC, NCC, Frost & Sullivan Analysis
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Treatment options for CRC mainly depend on the disease stage. Advanced CRC refers to
CRC at stage IV with metastasis. The following charts set forth the treatment regimen of CRC
according to NCCN 2025 and CSCO 2024, respectively.
Treatment Paradigm of CRC in the U.S. (NCCN 2025)
•F O L F O X
•C A P E O X
•F O L F I R I
• Targeted agents
b a s e do ng e n e t i c
profileszBevacizum
ab (with
chemotherapy),
Cetuximab or
Panitumumab (for
RAS wild-type
cancers)
• Checkpoint
inhibitor
immunotherapy
Systemic
therapy
Obstructed
YN
Colorectal Cancer
Early-stage Disease
Resectable
• Surgery: Primary treatment involves
colectomy with en bloc removal of
regional lymph nodes.
Advanced or Metastatic Disease
Invasive
-(non
metastatic)
Malignant
polyp Resectable Unresectable
•C o l e c t o m y
• Palliative
Surgery
Initial therapy (Intensive therapy)
• FOLFOX/CAPEOX ± bevacizumab/ (cetuximab or panitumumab)
• FOLFIRI ± bevacizumab/ (cetuximab or panitumumab)
• FOLFIRINOX ± bevacizumab
• Encorafenib + (cetuximab or panitumumab) + FOLFOX
Select second-line chemotherapy regimen based on first-line medication
• Adjuvant Chemotherapy: Considered
for high -risk stage II and all stage III
diseases, with options like CAPEOX
(capecitabine plus oxaliplatin) or FOLFOX
(leucovorin, fluorouracil, and oxaliplatin)
• Systemic therapy: For high-risk stage II
and stage III disease, regimens include:
• CAPEOX (capecitabine plus oxaliplatin)
• FOLFOX (leucovorin, fluorouracil, and
oxaliplatin)
First
Line
(~92%)
Second Line
and
Subsequent
Therapy
(2L:~65%
3L:~50%)
Disease
Progression
Biomarker-directed therapy:
• BRAF V600E mutation positive: Encorafenib+(cetuximab or
panitumumab) ± FOLFOX
• HER2 -amplified and RAS and BRAF WT:
(Trastuzumab+[pertuzumabor lapatinib or tucatinib])
• HER2-amplified (IHC3+): Fam-trastuzumab deruxtecan-nxki
• KRAS G12C mutation positive: (Sotorasibor
adagrasib)+(cetuximab or panitumumab)
• NTRK gene fusion-positive: Entrectinib, Larotrectinib,
Repotrectinib
• RET gene fusion-positive: Selpercatinib
Supportive care
OR
OR
Source: NCCN 2025, Frost & Sullivan Analysis
The first-line treatment is based on chemotherapy, and targeted drugs can be used in
combination after genetic testing (cetuximab or panitumumab can be used for patients with
EGFR mutations, and bevacizumab can be used for non mutations). Second line and subsequent
treatments are adjusted to different chemotherapy regimens and targeted drugs based on
first-line medication choice. Patients with special gene mutation can use corresponding
targeted drugs.
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Treatment Paradigm of CRC in China (CSCO 2024)
Colorectal Cancer
Metastatic (Stage IV)Non-metastatic (Early Stage)
Unresectable
(conversion therapy)
Resectable (postoperative
chemotherapy)
• Fluorouracil +/- oxaliplatin
+/- irinotecan
Unresectable (palliative treatment)Resectable
(neoadjuvant
chemotherapy)
•F O L F O X /
CapeOx /
FOLFIRI
• FOLFIRI / FOLFOX +/- cetuximab
• FOLFIRI / FOLFOX / CapeOx / FOLFOXIRI +/- bevacizumab
• Fluorouracil-based +/- bevacizumab
• Anti-PD-1 monoclonal antibody
• Nivolumab + lpilimumab
• FOLFIRI / FOLFOX +/- cetuximab
• FOLFIRI / FOLFOX / CapeOx +/- bevacizumab
• Irinotecan +/- cetuximab / bevacizumab
• Irinotecan / oxaliplatin + raltitrexed
• Irinotecan + capecitabine +/- bevacizumab
• Anti-PD-1 monoclonal antibody
• Nivolumab + lpilimumab
• Irinotecan + cetuximab + vemurafenib
• Irinotecan +/- cetuximab
• Regorafenib
• Fruquintinib
• Anti-PD-1 monoclonal antibody
• Nivolumab + lpilimumab
• Raltitrexed
• Irinotecan + cetuximab + vemurafenib
First
Line
(~90%)
Second
Line
(~62%)
Third
Line
(~50%)
Disease
Progression
Disease
Progression
• Fluorouracil
•5 - F U / L V
• CapeOx
•F O L F O X
• Without urgent symptoms,
patient receives PD-1/CTLA-
4 monoclonal antibody
therapy before radical
surgery.
• Postoperative adjuvant
chemotherapy usually starts 3
weeks to 2 months after
surgery and last 3 or 6
months.
• Combination with
bevacizumab or cetuximab
improves prognosis, but the
two targeted drugs are not
recommended to be used at
the same time
•L e n g t h o f
neoadjuvant
chemotherapy is
limited to within
2-3 month, with
FOLFOX/Cape
Ox as first
choice.
Note:
1. FOLFOX=oxaliplatin + leucovorin + 5-FU; FOLFIRI=irinotecan + leucovorin+ 5-FU; CapeOx=oxaliplatin +
capecitabine.
Source: CSCO 2024, Frost & Sullivan Analysis
Abbreviations: FOLFOX = oxaliplatin + leucovorin + 5-FU; FOLFIRI = irinotecan + leucovorin + 5-FU;
CapeOx = oxaliplatin + capecitabine
Similarly, the principles for selecting first-line and second-line drugs for advanced CRC
in China are similar to those in the United States, but lack targeted drugs for specific genes,
such as KRAS G12C.
The KRAS G12C and G12D mutations are among the most common oncogene mutations
in CRC incidence. The diagrams below set forth the historical and projected incidences of
G12C and G12D mutated CRC from 2019 to 2033, respectively.
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Incidence of KRAS G12C mutated CRC, 2019-2033E
China GlobalCAGR
2019-2024
2024-2033E
1.6%
2.4%
2.6%
1.9%
Thousand
64.7 65.8 67.5 67.4 68.8 70.2 71.7 73.5 75.3 77.1 79.0 80.9 82.7
86.584.6
20202019 2021 2022 2023 2024 2025E 2026E 2028E 2029E 2030E 2031E 2033E2032E
16.7 17.1 17.6 18.1 18.6 19.0 19.4 19.8
2027E
20.1 20.5 20.9 21.3 21.7 22.522.1
48.0 48.7 49.9 49.3 50.2 51.2 52.3 53.7 55.2 56.6 58.1 59.6 61.1 64.162.6
ChinaROW
Source: IARC, NCCN, Frost & Sullivan Analysis
Incidence of KRAS G12D mutated CRC, 2019-2033E
China GlobalCAGR
2019-2024
2024-2033E
1.6%
2.4%
2.6%
1.9%
Thousand
20202019 2021 2022 2023 2024 2025E 2026E 2028E 2029E 2030E 2031E 2033E 2032E2027E
ChinaROW
75.4 77.4 79.5 81.7 83.9 85.7 87.5 89.2 90.9 92.6 94.4 96.1 97.9 101.499.7
221.9 225.7 231.4 231.2 235.9 240.6 245.8 252.0 258.2 264.5 270.9 277.3 283.7
296.7290.2
146.5 148.3 151.9 149.5 152.0 154.9 158.3 162.8 167.3 171.9 176.5 181.1 185.8 195.3190.5
Source: IARC, NCCN, Frost & Sullivan Analysis
CRC ranks as the second most lethal and the third most commonly-diagnosed cancer
globally. The incidence of CRC among the younger population has also been rising, a trend
expected to continue over the next decade, and such trend is especially pronounced in Asian
and African populations. Additionally, metastatic CRC (“ mCRC ”), with its complex and
heterogeneous nature, further contributes to poor outcomes for many patients, complicating the
development of effective targeted treatments. While other cancers have seen significant
advancements in targeted therapy availability, treatment options for mCRC remain limited.
Despite extensive research, there is still a relative shortage of therapies that address the
common genetic mutations found in mCRC patients.
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Pancreatic cancer
Pancreatic cancer is an aggressive disease in which malignant cells originate in the
pancreatic tissue. Pancreatic cancers have certain prevalent genetic mutations, the most
commonly mutated genes being KRAS (approximately 85%) and loss-of-function mutations in
tumor suppressors, such as TP53, CDNK2A, DPC4/SMAD4, and BRCA2.
The global incidence of pancreatic cancer rose from 471.5 thousand to 532.6 thousand
between 2019 and 2024, with a CAGR of 2.5% and is expected to continue increasing to 667.3
thousand by 2033. In China, the incidence of pancreatic cancer increased from 108.5 thousand
in 2019 to 125.0 thousand in 2024, with a CAGR of 2.9% and is expected to further increase
to 149.9 thousand in 2033. The diagram below sets forth the historical and projected incidence
of pancreatic cancer from 2019 to 2033.
Global and China Incidence of Pancreatic Cancer, 2019-2033E
CAGR
Period
China ROW
2019-2024
2024-2033E
2.3%
2.7%
Global
2.5%
2.5%
2.9%
2.0%
Thousand
471.5 495.8 508.9 511.0 521.9 532.6 544.5 559.2 574.1 589.2 604.5 619.9 635.6 667.3651.3
20202019 2021 2022 2023 2024 2025E 2026E 2028E 2029E 2030E 2032E 2031E 2033E
108.5 111.8 115.1 118.7 122.3 125.0 127.7 130.4
2027E
133.1 135.9 138.6 141.4 144.2 147.0 149.9
363.0 384.0 393.7 392.3 399.6 407.5 416.7 428.8 441.0 453.3 465.9 478.5 491.4 517.4504.3
China ROW
Source: WHO, NCC, IARC, Frost & Sullivan Analysis
Treatment options for pancreatic cancer mainly depend on the disease stage. The
following charts set forth the treatment regimen of pancreatic cancer according to NCCN 2025
and CSCO 2024, respectively.
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Treatment Regimen of Advanced and Metastatic Pancreatic Cancer (NCCN 2025)
Locally Advanced and Metastatic Pancreatic Cancer
Maintenance Therapy for Patients who have response or stable disease after 4–6 months of chemotherapy
 Olaparib if previous platinum-based chemotherapy (only for germline BRCA1/2 mutations)
 Clinical trial
 Capecitabine if previous first-line FOLFIRINOX
 Gemcitabine single agent or Gemcitabine + albumin-bound paclitaxel modified schedule if previous first-line gemcitabine + albumin-bound paclitaxel
First
Line
(~92%)
Second
Line
(~62%)
Disease
Progression
Performance Status(PS) 0-1
 FOLFIRINOX or modified FOLFIRINOX
 Gemcitabine + albumin-bound paclitaxel
 Liposomal irinotecan + 5-FU + leucovorin +
oxaliplatin (NALIRIFOX)
 NALIRIFOX
Preferred Regimens:
 Entrectinib / Larotrectinib / Repotrectinib if
NTRK gene fusion-positive
 Pembrolizumab if no prior immunotherapy
Other Recommended Regimens:
 Dabrafenib + trametinib (if BRAF V600E
mutation-positive)
 Selpercatinib (if RET gene fusion positive)
PS=3
 Capecitabine
 Continuous infusion 5-FU
 Gemcitabine
 Palliative and best supportive care
Preferred Regimens:
 Palliative and best supportive care
Other Recommended Regimens:
 Capecitabine
 Continuous infusion 5-FU
 Gemcitabine
PS=2
 Capecitabine
 Gemcitabine
 Gemcitabine + albumin-bound paclitaxel
 5-FU + leucovorin + oxaliplatin (FOLFOX)
 5-FU + leucovorin + irinotecan (FOLFIRI)
 CapeOx
Preferred Regimens:
 If prior fluoropyrimidine-based therapy:
/g1905-FU + leucovorin+ liposomal irinotecan (if no
prior irinotecan)
/g190Gemcitabine +albumin-bound paclitaxel
 If prior gemcitabine-based therapy:
/g1905-FU + leucovorin+ liposomal irinotecan
Other Recommended Regimens:
 Capecitabine
 Continuous infusion 5-FU
 Gemcitabine
Source: NCCN2025v2, Frost & Sullivan Analysis
The standard first-line treatment for locally advanced and metastatic pancreatic cancer is
FOLFIRINOX chemotherapy (suitable for patients in good condition), or gemcitabine
combined with albumin paclitaxel. If there is a BRCA mutation, targeted drug olaparib can be
added. Second line treatment involves switching to another chemotherapy regimen based on
first-line treatment, as well as targeting drugs specific to mutated genes, including NTRK,
BRAF V600E and RET.
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Treatment Regimen of Pancreatic Cancer (CSCO 2024)
Pancreatic Cancer
First
Line
~90%
Second
Line
~62%
Disease
Progression
Good Physical Fitness Poor Physical Fitness
Borderline Resectable
Pancreatic Cancer
Resectable Pancreatic
Cancer
Unresectable Local Progression or Distant Metastasis
Pancreatic Cancer
• GEM+ albumin-bound paclitaxel (AG regimen) (Grade 1A)
• FOLFIRINOX regimen (Grade 1A)
• GEM monotherapy (Grade 1A)
• S-1 monotherapy (Grade 1A)
• GEM combined with ERK inhibitor monotherapy (KRAS wild type)
(Grade 1A)
• Platinum-based therapy (for BRCA1/2 mutations): If no disease
progression after 16 weeks of treatment, consider maintenance
therapy with olaparib (Grade 1A).
• GEM monotherapy (Grade 1A)
• S-1 monotherapy (Grade 1A)
• GEM combined with ERK inhibitor monotherapy (KRAS wild type)
(Grade 1A)
• Best supportive care
• Participation in clinical trials
• GEM monotherapy
• S-1 monotherapy
• Best supportive care
• Nanoliposomal irinotecan + 5-FU/LV (Grade 1A)
• GEM-based, switch to 5-FU-based therapy.
• 5-FU-based, switch to GEM-based therapy.
• For patients with recurrent distant metastases more than 6 months
after adjuvant chemotherapy, other than repeating the original
therapy, alternative systemic chemotherapies can also be considered.
• Participation in clinical trials
Source: CSCO 2024, Frost & Sullivan Analysis
The first-line chemotherapy regimens between China and the U.S. are similar, but
second-line treatment relies more on basic chemotherapy in China.
The KRAS G12D mutation is among the most common oncogene mutations in pancreatic
cancer incidence. The diagram below sets forth the historical and projected incidences of G12D
mutated pancreatic cancer from 2019 to 2033.
Incidence of KRAS G12D Mutated Pancreatic Cancer, 2019-2033E
54.8
China GlobalCAGR
2019-2024
2024-2033E
2.5%
2.5%
2.9%
2.0%
Thousand
174.5 183.4 188.3 189.1 193.1 197.1 201.5 206.9 212.4 218.0 223.7 229.4 235.2 246.9241.0
20202019 2021 2022 2023 2024 2025E 2026E 2028E 2029E 2030E 2031E 2033E2032E
41.2 42.5 43.8 45.1 46.5 47.5 48.5 49.6
2027E
50.6 51.6 52.7 53.7
133.2 141.0 144.5 144.0 146.6 149.5 152.9 157.3 161.8 166.4 171.0 175.6 180.4 189.9185.1
ChinaROW
57.055.9
Source: IARC, NCCN, Frost & Sullivan Analysis
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Pancreatic cancer has a rising incidence and is one of the most lethal human malignancies.
The 5-year survival rate of pancreatic cancer is approximately 13% and two factors mainly
contributed to the low survival rate. First, early diagnosis at a curable stage is difficult because
patients with early-stage pancreatic cancer rarely exhibit symptoms. The second factor is the
lack of effective treatment options. The treatment of pancreatic cancer mainly includes surgical
treatment, radiotherapy, chemotherapy, interventional therapy, endoscopic retrograde
cholangiopancreatography related treatment and traditional Chinese medicine treatment.
Currently, the option of targeted therapies is quite limited. Several targeted therapies have been
assessed in combination with gemcitabine, but none has been shown to significantly impact
outcomes. As pancreatic cancer is mainly driven by mutations in the KRAS oncogene, we
believe that our KRAS-targeted inhibitors have the potential to become a promising therapeutic
solution to pancreatic cancer, one of the most lethal forms of cancer.
OVERVIEW OF RIPK1 DRUG MARKET
Receptor-interacting serine/threonine-protein kinase 1 (“ RIPK1 ”) is a master regulator of
cellular fate, balancing pro-survival nuclear factor kappa B (“ NF-/H9260B”) signaling and cell death
in response to a wide range of inflammatory processes, apoptosis, necroptosis and pro-death
stimuli in human diseases. Activation of RIPK1 kinase has been observed in pathological
samples from autoimmune, inflammatory and neurodegenerative conditions. Additionally, both
monogenic and polygenic variants of known RIPK1 regulators contribute to inflammatory and
neurodegenerative diseases. Furthermore, RIPK1 kinase activation plays a central role in
mediating cell necroptosis following the activation of tumor necrosis factor receptor
1( “ TNFR1 ”) by TNF- /H9251, particularly in apoptosis-deficient conditions.
RIPK1 inhibitors downregulate RIPK1 kinase activity and effectively suppress cell death
induced by TNF- /H9251and caspase inhibitors. Inhibition of RIPK1 has demonstrated efficacy
across a wide range of human diseases
*, including autoimmune diseases such as psoriasis,
ulcerative colitis, lupus, and rheumatoid arthritis, as well as neurodegenerative conditions such
as amyotrophic lateral sclerosis, multiple sclerosis and Alzheimer’s disease.
Competitive Landscape of RIPK1 Drug Market
The prevalence of PAD globally rose from 271.6 million in 2019 to 322.3 million in 2024,
with a CAGR of 3.5%. It is expected to continue increasing to 378.1 million by 2033, reflecting
a CAGR of 1.8% from 2024. The prevalence of PBC globally rose from 1,115.8 thousand in
2019 to 1,206.2 thousand in 2024, with a CAGR of 1.6%. It is expected to continue increasing
to 1,353.9 thousand by 2033, reflecting a CAGR of 1.3% from 2024.
As of the Latest Practicable Date, there was no approved RIPK1 inhibitor drug globally.
There were seven RIPK1 inhibitor candidates under clinical development globally, and
GFH312 was the only one developed for the treatment of PAD and PBC as of Latest Practicable
Date. The following table sets forth the clinical-stage RIPK1 inhibitor candidates globally.
* Degterev A, Ofengeim D, Y uan J. Targeting RIPK1 for the treatment of human diseases. Proc Natl Acad Sci
U S A. 2019;116(20):9714-9722.
Bai Y , Qiao Y , Li M, Y ang W, Chen H, Wu Y , Zhang H. RIPK1 inhibitors: A key to unlocking the potential
of necroptosis in drug development. European Journal of Medicinal Chemistry. 2024; 265(5):116-123.
Mifflin L, Ofengeim D, Y uan J. Receptor-interacting protein kinase 1 (RIPK1) as a therapeutic target. Nat Rev
Drug Discov. 2020;19(8):553-571.
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Pipeline of Clinical-stage RIPK1 Inhibitor Drug Candidates Globally
Drug
names Indication Latest
status Company Therapeutic
strategy
Treatment
Line
Route of
Administration
Treatment
Schedules Efficacy & Safety Country/
region
First
posted
date
GDC-8264
Cardiac Surgery-
Associated Acute
Kidney Injury and
Major Adverse
Kidney Events
prevention
Phase 2 Genentech mono oral
single-
(5–225 mg)
and multiple-
(50 and 100 mg)
once daily,
up to 14 days
–
US,
Australia,
Europe,
Canada, etc.
2024-09-19
ABBV-668 Moderate to
severe UC Phase 2 AbbVie Mono oral BID, for 52
weeks –
US,
Belgium,
France, etc
2022-10-06
Eclitasertib
Adult with
moderate to
severe UC
Phase 2 Sanofi & Denali
Therapeutics Mono oral
administered
at 3 assigned
dose levels,
dose level not
disclosed
no study
drug-related
severe or serious
AEs reported,
At doses of 100
mg and above,
> 90% inhibition
of RIPK1
phosphorylation in
human peripheral
blood mononuclear
cells was
observed with
eclitasertib
at 12 h post-dose
US,
China,
Europe, etc.
2022-10-20Not
applicable
Not
applicable
Not
applicable
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--- page 207 ---
Drug
names Indication Latest
status Company Therapeutic
strategy
Treatment
Line
Route of
Administration
Treatment
Schedules Efficacy & Safety Country/
region
First
posted
date
GFH312
Inflammatory
conditions
(healthy
volunteer)
Phase 1 GenFleet Mono oral
a single
ascending
dose up to
500 mg (part I)
or once-daily
repeated doses up
to 200 mg for
14 days (part II)
TEAE: part I
42.1%, part
II 63.2%
Australia,
China 2020-12-21
SIR9900
Systemic
Inflammatory
Response
Syndrome
(healthy volunteer)
Phase 1 SIRONAX Mono oral
30mg QD, 10-day
cycle or 200mg for
one day
– China 2025-4-16Not
applicable
Not
applicable
LY3871801
Moderately-to-
severely
active RA
Phase 2 Eli Lilly & Rigel
Pharmaceuticals Mono oral
administered
at the
assigned dose
level, dose
level not
disclosed
No TEAEs
US,
United
Kingdom,
France, etc.
2023-05-08
AC-003 aGVHD Phase 1b Accro
Bioscience
Combo
with
glucocorticoid
Not
applicable
Not
applicable
oral BID or QD, 28-
day cycle – China 2023-12-12
Note: Ongoing Clinical trials with first posted date up to Latest Practicable Date, initiated by companies are included.
Source: CDE, Clinical Trials, Frost & Sullivan Analysis
Abbreviations: UC: urothelial carcinoma; MS: multiple sclerosis; RA: rheumatoid arthritis; aGVHD: acute graft-versus-host disease
INDUSTRY OVERVIEW
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Entry Barriers of RIPK1 Drug Market
The RIPK1 drug market has the following entry barriers:
 Development Obstacles. The complex structure of RIPK1 necessitates
comprehensive studies in structural biology to elucidate its active site and
mechanism of action. RIPK1 participates in complex signaling pathways, and it
requires a thorough understanding of molecular biology and cellular signaling to
develop RIPK1-targeted drugs. This complexity presents significant barriers for
pharmaceutical companies lacking the requisite expertise or technology to enter the
market. Moreover, the current RIPK1 inhibitors are constrained to specific
chemotypes, and the optimization of RIPK1 inhibitors to enhance their activity and
selectivity remains a substantial challenge.
 Safety Concern . Developing effective RIPK1 inhibitors with an acceptable safety
profile presents a significant challenge. Although the targeting of RIPK1 itself
appears to be relatively safe at least in short-term studies, the clinical development
of some of compounds has been discontinued due to potential safety signal. Adverse
events tend to be drug-specific and related to off-target effects, among which,
headache and gastrointestinal events are the most common. Elevated liver enzymes
were also observed with some drugs. Therefore, ensuring drug safety remains a
major concern in the development of RIPK1 inhibitors.
 Blood-brain Barrier Crossing . Studies have shown that elevated RIPK1 activity in
the brain drives neuroinflammation and cell necrosis, and it is believed to be
associated with various CNS and autoimmune diseases. Therefore, designing RIPK1
inhibitors capable of penetrating the blood-brain barrier will be key to achieving
breakthroughs. However, developing compounds that can safely and effectively
penetrate the blood-brain barrier without causing toxicity poses considerable
difficulties.
Growth Drivers and Future Trends of RIPK1 Drug Market
According to Frost & Sullivan, the RIPK1 drug market growth has primarily been driven
by the following factors:
 Viable Drug Target with Considerable Potential. The critical regulatory role of
RIPK1 in mediating the interactions between inflammatory responses, apoptosis,
and necroptotic signaling pathways, combined with its kinase structure that is
well-suited for the development of pharmacologically specific small-molecule
inhibitors, has established RIPK1 as an attractive drug target for pharmaceutical
companies.
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--- page 209 ---
 Broad Therapeutic Applications . RIPK1 inhibitors are being studied in clinical trials
for a diverse array of therapeutic applications, including autoimmune disorders,
neurodegenerative diseases, and beyond. For instance, recent findings indicate that
RIPK1 degradation mediated through PROTAC can induce immune cell death and
improve the efficacy of antitumor therapies. Additionally, RIPK1 has also shown
promising potential in the treatment of atherosclerosis-related conditions.
 Combination Therapies . The therapeutic efficacy of RIPK1 inhibitors could be
potentially enhanced with reduced side effects if developed in combination with
other drugs. These combination therapies can target multiple pathways in conditions
such as neurodegeneration and autoimmune disorders, and they could potentially
yield improved patient outcomes and reduced drug resistance.
Major Indications of RIPK1 Drug
PAD
Peripheral Arterial Disease (“ PAD”) is a condition in which narrowed arteries reduce
blood flow to the limbs. Arteries are responsible for transporting oxygen-rich blood from the
heart to various parts of the body. However, the accumulation of cholesterol and scar tissue can
create plaque, which obstructs the arteries and limits the flow of blood, oxygen, and essential
nutrients to the arms and legs, leading to PAD. PAD is mainly caused by atherosclerosis, as
well as other factors including inflammation, trauma or injury, structural abnormalities in
ligaments or muscles, and radiation exposure. Major risk factors for PAD include smoking,
diabetes, hypertension, high cholesterol, obesity, advancing age, and a family history of the
condition, with atherosclerosis being the most prevalent cause.
The global prevalence of PAD increased from 271.6 million in 2019 to 322.3 million in
2024, and is expected to further increase to 378.1 million in 2033. In China, the prevalence of
PAD increased from 49.8 million in 2019 to 55.4 million in 2024, and is expected to further
increase to 66.4 million in 2033. The diagram below sets forth the historical and projected
prevalence of PAD from 2019 to 2033.
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Global and China Prevalence of PAD, 2019-2033E
Million
20202019 2021 2022 2023 2024 2025E 2026E 2028E 2029E 2030E 2031E 2033E 2032E2027E
China ROW
ChinaCAGR
2019-2024
2024-2033E
2.2%
2.0%
Global
3.5%
1.8%
271.6
301.8288.8280.2
312.0 322.3 330.4 338.2 345.4 352.2 358.5 364.6 370.1 375.4 378.1
221.7 229.5 237 248.7 257.8 266.8 273.8 280.3 286.3 291.8 297.0 301.8 306.1 310.2 311.7
49.8 50.7 51.9 53.1 54.2 55.4 56.6 57.9 59.1 60.3 61.6 62.8 64.0 65.2 66.4
Source: Research review, Frost & Sullivan Analysis
The global PAD drug market grew from US$8.1 billion in 2019 to US$10.4 billion in
2024, and is expected to further grow to US$14.0 billion in 2033. Greater China’s PAD drug
market grew from US$1.2 billion in 2019 to US$1.3 billion in 2024, and is expected to further
grow to US$1.6 billion in 2033. The diagram below sets forth the historical and projected
global and Greater China’s market sizes of PAD drugs from 2019 to 2033.
Global and Greater China PAD Drug Market, 2019-2033E
Billion USD
20202019 2021 2022 2023 2024 2025E 2026E 2028E 2029E 2030E 2031E 2033E 2032E2027E
Greater China ROW
Greater ChinaCAGR
2019-2024
2024-2033E
1.3%
2.5%
Global
5.0%
3.3%
8.1 8.5 8.9
9.5 9.9 10.4 10.8 11.3 11.7 12.1 12.5 12.9 13.3 13.7 14.0
1.2 1.2 1.4 1.3 1.3 1.3 1.3 1.4 1.4 1.4 1.5 1.5 1.5 1.6 1.6
6.9 7.3 7.6 8.1 8.6 9.1 9.5 9.9 10.3 10.7 11.0 11.4 11.7 12.1 12.3
Source: Frost & Sullivan Analysis
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Current Treatment Options and Limitations
The current treatment regimen of PAD mainly constitutes medical and exercise therapies,
preventive foot care and revascularization. However, these treatment options have notable
limitations. For instance, revascularization, such as percutaneous endovascular balloon dilation
or stenting, remains the primary intervention for patients with severe claudication, yet there is
a lack of pharmacological therapies specifically targeting the inflammatory mechanisms
underlying PAD. Moreover, many patients remain asymptomatic until the disease progresses to
a critical stage, at which point invasive surgical and pharmacological interventions become
necessary, yet these treatments often come with critical risks. The limitations of existing
treatment options call for more effective and less invasive treatment strategies with better
clinical outcome, lower risks and less complications. Given the observed elevation of RIPK1
expression in human atherosclerotic lesions, RIPK1 has been viewed as a potential therapeutic
target for reducing residual inflammation in patients at high risk of developing coronary artery
disease and subsequently PAD.
PBC
Primary biliary cholangitis (“ PBC”) is a chronic, progressive autoimmune cholestatic
disease that primarily affects the liver. It is characterized by non-suppurative inflammation of
the small intrahepatic bile ducts, which eventually leads to liver fibrosis and cirrhosis.
PBC predominantly affects middle-aged and older female patients and is diagnosed in
patients with high serum titres of antimitochondrial antibodies, elevated bile enzymes, and
distinctive liver pathology. A combination of genetic and environmental factors likely causes
PBC, although its precise pathogenesis remains unclear. The onset of PBC is often insidious,
with some patients presenting with cirrhosis at the time of diagnosis. Due to improved
understanding of the disease in recent years that has led to earlier detection, there are more
patients being diagnosed at the stage of small bile duct inflammation, where treatment response
tends to be more favorable.
The global prevalence of PBC increased from 1,115.8 thousand in 2019 to 1,206.2
thousand in 2024, and is expected to further increase to 1,353.9 thousand in 2033. In China,
the prevalence of PBC increased from 270.5 thousand in 2019 to 291.1 thousand in 2024, and
is expected to further increase to 320.7 thousand in 2033. The diagram below sets forth the
historical and projected prevalence of PBC from 2019 to 2033.
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Global and China Prevalence of PBC, 2019-2033E
1,115.8 1,135.7 1,154.8 1,171.4 1,187.6 1,206.2 1,222.5 1,239.1 1,255.5 1,272.0 1,288.4 1,304.8 1,321.2 1,337.5 1,353.9Thousand
20202019 2021 2022 2023 2024 2025E 2026E 2028E 2029E 2030E 2031E 2033E 2032E2027E
China ROW
ChinaCAGR
2019-2024
2024-2033E
1.5%
1.1%
Global
1.6%
1.3%
845.3 860.6
875.3 887.9 900.3 915.1 927.7 940.7 953.6 966.7 979.8 993.1 1,006.4 1,019.8 1,033.2
270.5 275.1 279.4 283.5 287.3 291.1 294.8 298.4 301.9 305.3 308.5 311.7 314.8 317.8 320.7
Source: Research review, Frost & Sullivan Analysis
The global PBC drug market grew from US$1,004 million in 2019 to US$1,147.3 million
in 2024, and is expected to further grow to US$1,542.2 million in 2033. Greater China’s PBC
drug market grew from US$235.0 million in 2019 to US$232.4 million in 2024, and is expected
to further grow to US$284.0 million in 2033. The diagram below sets forth the historical and
projected global and Greater China’s market sizes of PBC drugs from 2019 to 2033.
Global and Greater China PBC Drug Market, 2019-2032E
Million USD
20202019 2021 2022 2023 2024 2025E 2026E 2028E 2029E 2030E 2031E 2033E 2032E2027E
Greater China ROW
Greater ChinaCAGR
2019-2024
2024-2033E
-0.2%
2.3%
Global
2.7%
3.3%
1,004.2 1,033.5 1,062.5 1,089.8 1,117.2 1,147.3 1,181.6 1,219.3 1,261.6 1,305.1 1,349.8 1,395.9 1,443.3 1,492.0 1,542.2
235.0 237.2 255.3 246.1 235.2 232.4 236.8 241.8 247.1 253.1 260.0 266.3 272.5 278.3 284.0
769.2 796.3 807.2 843.7 882.0 914.9 944.8 977.4 1,014.4 1,051.9 1,089.9 1,129.5 1,170.8 1,213.7 1,258.1
Source: Frost & Sullivan Analysis
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Current Treatment Options and Limitations
As of the Latest Practicable Date, there were four drugs approved by the FDA for the
treatment of PBC. Current recommended treatments include first-line treatment of
ursodeoxycholic acid (“ UDCA ”) and second-line treatment of obeticholic acid (“ OCA”).
Similarly in China, UDCA is generally the first-line treatment option to PBC. However,
approximately 40% of patients with PBC exhibit incomplete response to UDCA, leaving
considerable medical need for novel treatments of PBC.
When a patient is diagnosed with PBC, UDCA is used as a first-line medication.
Currently, for the treatment of PBC, both in China and globally, the recommended dosage is
13-15mg/kg/day, and it usually does not require discontinuation of medication. According to
the median bid price of UDCA in China in 2025, the annual cost of medication for Chinese
patients is approximately RMB3,558.8 (calculated based on an average weight of 60kg for
Chinese patients). The annual cost of medication for U.S. patients is approximately $80,088
(calculated based on an average weight of 80kg).
For patients with poor biochemical response to UDCA, their long-term prognosis is poor
and survival rate is low. In that case, second line treatment may be considered, such as UDCA
in combination with OCA or fibrate drugs (e.g., bezafibrate and fenofibrate). However, OCA
and fibrate drugs (including bezafibrate and fenofibrate) have not been approved in China for
the treatment of PBC. The recommended dosage for OCA is 5-10mg/day, and the annual cost
for U.S. patients using this medication is approximately $129,730.
If PBC only progresses to decompensated cirrhosis, liver transplantation may be
considered.
OVERVIEW OF CACHEXIA DRUG MARKET
Overview of Cachexia
Cachexia, including cancer cachexia, is a common and severe condition characterized by
appetite loss, accelerated breakdown of muscle and fat tissue, subsequent weight loss and
decreased physical function. These symptoms not only impact patient tolerability to treatment
but also significantly deteriorate their quality of life. Overall, cachexia is responsible for 20%
of all cancer-related deaths and is an indicator of poor prognosis.
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Prevalence of Cachexia in Different Cancer Types
Breast, Sarcoma, Leukemia &
Hodgkin Lymphoma 40%
61%
87%
Colon, Lung, Prostate &
Non-Hodgkin Lymphoma
Pancreatic & Gastric Cancers
Competitive Landscape of Cachexia Drugs
As of the Latest Practicable Date, there was only one approved drug specifically for the
treatment of cancer cachexia globally, being Adlumiz, a ghrelin receptor agonist co-developed
by Helsinn Group and Ono Pharmaceutical Co., Ltd. which was approved by the
Pharmaceuticals and Devices Agency of Japan in 2021 for the treatment of cancer cachexia in
malignant tumors of NSCLC, gastric cancer, pancreatic cancer or CRC. There were 10 cachexia
drug candidates under clinical development globally as of the Latest Practicable Date. The
following table sets forth the clinical-stage cachexia drug candidates globally.
Pipeline of Clinical-stage Cachexia Drug Candidates Globally
Drug Target Indication Latest
status Company Therapeutic
strategy
Treatment
Line
Route of
Administration
Treatment
Schedules
Efficacy &
Safety Country First posted
date
Ponsegromab GDF15
cancer, cachexia, and
elevated GDF 15 Phase 2
Pfizer
Mono NA
subcutaneous
100/200/400mg
every 4 weeks
for 12 weeks
100mg group: body
weight +2.02%,
TRAE 7.7%
200mg group: body
weight +3.48%,
TRAE 8.9%
400mg group: body
weight +5.61%,
FAACT-ACS
(12-week) 4.11,
FAACT-5IASS
(12-week) 2.30
US, Europe,
China, Japan 2022-09-19
Anamorelin
Hydrochloride GHSR
Cancer Induced-Weight
Loss and Anorexia in
Advanced PC
Phase 2
Helsinn
Combo with
standard of care
chemotherapy
1L
oral
100mg QD,
24-week cycle – US 2021-04-14
cachexia and
metastatic PDAC Phase 2b/3
Combo with
standard of care
chemotherapy
1L 200/400mg
Q4W – NA 2025-5-25
Cachexia/anorexia in
NSCLC Phase 1
Combo with
standard of care
chemotherapy
1L 100mg QD,
24-week cycle
body weight
change from
baseline:
1.938kg
(Placebo:
0.594kg)
China, US,
Bularia,
Europe, etc.
2018-11-15
STC008 GHSR
Cachexia of NSCLC, C,
PC, CRC and other
advanced solid tumors
Phase 1a Sintanovo Mono NA subcutaneous
10/30/100/300/
500/750μg or
1/1.25/1.5mg,
single dose
– China 2024-09-29
JMT203 GFRAL Cachexia Phase 1 JMT-Bio Mono NA subcutaneous 5-300mg,
Q3W – China 2024-01-04
AV-380 GDF15 Metastatic Cancer Patients
With Cachexia Phase 1 AVEO
Pharmaceuticals
Combo with standard
of care chemotherapy 1L intravenous
7 doses in total,
the 2nd dose will
be 28 days after the
1st, the remaining
5 doses will be
given every
2 weeks
– US 2023-05-19
TCMCB07 MC4R,
MC3R Cachexia of CRC Phase 2 Endevica Bio
Combo with
standard of care
chemotherapy
1L subcutaneous 12.5/25/50mg QD,
28-day cycle – US, Canada 2025-04-22
DS010 – Cachexia Phase 1 Dartsbio Mono NA intravenous 15-400mg,
single dose – China 2025-04-28
GFS202A GDF15, IL6 Cachexia Phase 1 GenFleet Mono NA intravenous 240mg, Q3W,
12 weeks – China 2025-03-19
NGM120 GFRAL Colorectal Cancer
with Cachexia Phase 2 NGM
Biopharmaceuticals Mono NA su bcutaneous Q4W/Q8W – US 2025-06-24
Visugromab GDF15 cachexia Phase 2/3 CatalYm Mono NA intravenous NA – NA 2025-08-08
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Note: Ongoing Clinical trials with first posted date up to the Latest Practicable Date, initiated by companies are
included.
Source: CDE, Clinical Trials, Frost & Sullivan Analysis
Current Treatment Options and Limitations
As of the Latest Practicable Date, progesterone and glucocorticoids were the major drugs
used to alleviate the symptoms of cachexia in clinical practice. However, such treatment
options primarily increase fat instead of muscle mass of patients. Nutritional interventions may
also improve quality of life for patients suffering from cachexia, although in the refractory
stage of cachexia, nutritional interventions may not fully reverse weight loss and metabolic
abnormalities. Given the limited existing treatment options, there are considerable unmet
medical needs for effective treatments for cachexia, such as targeted therapies for important
cytokines including GDF15 and IL-6. In particular, GDF15 has been recently recognized as a
key driver target in various diseases, including cachexia, and reported positive data from
clinical study of ponsegromab, a monoclonal antibody directed against GDF15 developed by
Pfizer, underscored its therapeutic potential.
Entry Barriers and Future Trends of Cachexia Drug Market
There are considerable entry barriers for the development of cachexia drugs:
 Complex Disease Mechanisms . The pathogenesis of cachexia is complex and
involves multiple factors, including tumor burden, chronic inflammation, and other
contributing elements. This complexity makes drug development challenging and
necessitates targeted drug design for specific underlying causes. Due to the
complexity of cachexia, effective methods for reversing it remain unclear, and
therapeutic options are still in the exploratory stage.
 Lack of Clinical Evidence. The first drug globally for cancer cachexia, Adlumiz, was
approved in Japan. However, its effects on physical functioning, quality of life, and
overall survival of patients with cancer have not been well established. Other drugs
for the treatment of cachexia remain in the early stages of clinical research, and
there is limited clinical evidence to guide the further development of cachexia drugs.
 Difficulty to Conduct Clinical Trials . Clinical trials for cachexia drugs demand
considerable time and resources due to the relatively complex patient population and
their poor health conditions. Additionally, these trials face challenges in both design
and execution, with a critical need to ensure the safety and efficacy of such
treatments.
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According to Frost & Sullivan, future cachexia drug market may observe the following
trends:
 Increasing Clinical Needs . The global cancer incidence is projected to continue its
upward trend, having reached 21.3 million cases in 2024 and is estimated to further
reach 26.0 million by 2033. This trend is likely to result in a higher number of
patients affected by cachexia, driving an anticipated increase in demand for effective
cachexia treatments in the coming years.
 Advancements in Targeted Drug Development . Currently, the primary therapeutic
options for treating cachexia are appetite stimulants and various symptom-
management medications, while numerous targeted therapies are actively being
researched or developed preclinically. Pharmaceutical companies are investing in
innovative drug candidates that can intervene at different stages of cachexia
progression, and R&D investment in targeted therapies for cachexia is expected to
continue to grow.
 Personalized and Comprehensive Treatment . Given the complex causes of cachexia,
personalized treatment strategies are expected to evolve and tailored for different
patient populations. A comprehensive approach, involving multi-pathway and
multi-target combination drug therapy alongside multidisciplinary collaboration,
offers a promising strategy to enhance treatment efficacy. This approach integrates
medications, dietary and nutritional support, psychological care, and physical
exercise for a holistic intervention.
 Increasing Awareness . In the future, ongoing research into the causes of cachexia,
along with increased awareness among healthcare professionals and patients, is
expected to lead to improved diagnosis and more proactive treatment strategies of
cachexia.
OVERVIEW OF CDK9-TARGETED AND TGF- /H9252R1-TARGETED DRUG MARKET
Overview of CDK9-targeted Drug
Cyclin-dependent kinases (“ CDKs ”) are a group of serine/threonine kinases that regulate
major steps throughout the cell cycle. As a transcriptional regulator, CDK9 plays crucial roles
in tumorigenesis and tumor growth. CDK9, when associated with cyclin T, forms the positive
transcription elongation factor b (“ P-TEFb ”) complex. This complex regulates gene
transcription elongation and mRNA maturation of super enhancer-regulated genes, including
the myelocytomatosis oncogene (“ MYC”) (a proto-oncogene involved in cell growth and
cell-cycle progression) and myeloid cell leukemia 1 (“ MCL1 ”) (an anti-apoptosis gene).
Together, these genes modulate proliferation and survival of cancer cells. Notably, deregulation
in the CDK9-related pathway has been reported in several human malignancies, such as
lymphomas, leukemia, neuroblastoma, primary neuroectodermal tumors, rhabdomyosarcoma,
and prostate cancer. These findings suggest that CDK9 could be a promising therapeutic target
for cancer therapy. CDK9 inhibitors have emerged as promising therapeutic agents for various
hematologic cancers due to their ability to reduce the levels of short-lived oncogenic proteins,
induce apoptosis, and inhibit tumor growth.
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Major Indication of CDK9-targeted Drug
AML
Acute myeloid leukemia (“ AML”) and diffuse large B-cell lymphoma (“ DLBCL ”) are
two hematologic cancers that CDK9 inhibitors could potentially target. AML is characterized
by a rapid increase in the number of immature blood cells, whose genetic damage impairs their
abilities to function as normal blood cells. AML typically originates in the blood and bone
marrow — the spongy, red tissue within large bones — and can sometimes spread to other parts
of the body. It progresses rapidly and aggressively, necessitating immediate treatment. The
global incidence of AML increased from 86.1 thousand in 2019 to 97.1 thousand in 2024, and
is expected to further increase to 112.9 thousand in 2033. In China, the incidence of AML
increased from 29.4 thousand in 2019 to 31.5 thousand in 2024, and is expected to further
increase to 34.3 thousand in 2033.
Chemotherapy, particularly cytarabine-based therapies, remains the primary treatment for
AML. However, intensive chemotherapy may not be suitable for patients in poor health
condition and advanced age. Even with chemotherapy being an available treatment, over 50%
of patients eventually experience disease progression due to relapsed/refractory AML. A
potential treatment option arises recently as CDK9 inhibitors have shown promise in
preclinical models, especially in AML, where they have demonstrated the ability to reduce key
oncogenic proteins and improve survival in both animal models and clinical trials.
Competitive Landscape of CDK9-targeted Drugs
As of the Latest Practicable Date, there was no approved CDK9 inhibitor globally, and
there were 8 CDK9 inhibitor candidates under clinical development globally as of Latest
Practicable Date. The following table sets forth the clinical-stage CDK9 inhibitor candidates
globally.
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Pipeline of Clinical-stage CDK9 Inhibitor Drug Candidates Globally
Drug Indication Latest
status Company Therapeutic
strategy
Treatment
Line
Route of
Administration Treatment Schedules Efficacy
& Safety
Country/
region
First
posted
date
QHRD107 R/R AML Phase 2 Qianhong
Biopharma
Combo with
venetoclax
and
azacitidine
3L+ oral
40/60/80mg BID
+ venetoclax
QD  according
to a ramp-up
schedule to a
maximum dose
of 400 mg,
28-day cycle
ORR 41.3%
mOS
12.8 months,
ORR 60.9%
China 2023-8-18
GFH009/
SLS009
R/R DLBCL
Phase 1/2 GenFleet/
SELLAS
Combo with
zanubrutinib 3L+
infusion
GFH009
60/75/100mg
QW +
Zanubrutinib
160mg BID,
28-day cycle
All pts: ORR 67%,
AE (grade  ≥3) 55.6%;
non-GCB DLBCL:
DCR 83%
China 2024-2-18
R/R PTCL Mono 3L+ GFH009 QW,
21-day cycle – China
2023-5-25
R/R
hematologic
malignancies
Mono and
combo with
venetoclax
and
azacitidine
Lymphoma
3L+, AML
2L
45/60mg QW
or 30mg BIW
+ venetoclax
+ azacitidine
ORR: 44% (AML-MR),
50% (AML MR with
Myelomonocytic/Myelo
monoblastic (M4/M5)
Subtype) mOS: 8.9
months (AML-MR),
8.8 months (all r/r to
venetoclax-based
regimens pts)
US,
China 2020-10-19
SYHX1903
R/R
hematologic
malignancies
Phase 1/2 CSPC Mono NA oral SYHX1903 QD –– 2021-09-24
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Drug Indication Latest
status Company Therapeutic
strategy
Treatment
Line
Route of
Administration Treatment Schedules Efficacy
& Safety
Country/
region
First
posted
date
AZD4573
R/R
haematological
malignancies
Phase 1/2 AstraZeneca
Combo with
anti-cancer
agents
2L+ infusion
AZD4573 6/9/12mg
QW ± acalabrutinib
100mg BID
ORR 50%,
CR 25%
Australia
US,
Europe
2020-11-16
PRT2527
R/R
hematologic
malignancies
Phase 1 Prelude
Therapeutics
Mono and
combo with
zanubrutinib
or venetoclax
1L+ infusion
PRT2527
9/15/18mg/m2
QW ± Zanubrutinib
QD/BID
ORR: 17.4%
(mono), 38.5%
(combo with
zanubrutinib)
US
Canada,
Europe
2022-12-27
Voruciclib
R/R B cell
malignancies
or AML
Phase 1 MEI Pharma
Mono or
Combo with
venetoclax
3L+ oral
Voruciclib 7 dose
levels between
50 mg and 300 mg
on days 1-14 of
28-day cycles,
Venetoclax was
administered at
200 mg on days
1-21 and 400 mg
on days 22-28
death 17.1% US 2018-06-06
TG02 R/R HGG Phase 1 CotheraBio Mono 2L+ oral 100/150/200/250mg
BIW
mPFS 1.77
months, TRAE
(grade 3/4) 50%
China 2019-1-18
YK-2168
Histologically
or cytologically
confirmed
advanced or
unresectable
solid tumors,
and R/R NHL
Phase 1 YOKO
Pharmaceutical Mono 1L+ infusion
5mg QW ramp-up
to a maximum dose
of 30 mg, 21-day
cycle
– China 2021-11-17
Note: Ongoing Clinical trials with first posted date up to Latest Practicable Date, initiated by companies are included.
Source: CDE, Clinical Trials, Frost & Sullivan Analysis
INDUSTRY OVERVIEW
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Overview of TGF- /H9252R1-targeted Drug
TGF- /H9252is a multifunctional cytokine that binds and activates TGF- /H9252receptor II
(“TGF- /H9252R2”) on the cell membrane. In turn, TGF- /H9252R2 phosphorylates and activates
TGF- /H9252R1, which subsequently phosphorylates and activates the downstream Smad binding
element, which directly regulates gene expression and facilitates various biological functions.
In cancer cells, the activation of the TGF- /H9252signaling pathway promotes epithelial-to-
mesenchymal transition and metastasis, inhibits antitumor immune responses, and enhances
angiogenesis and tissue fibrosis within the tumor microenvironment, thereby driving tumor
progression. Furthermore, elevated expression of TGF- /H9252signaling pathway genes in blood and
tumors has been observed in patients with various solid tumors, including hepatocellular
carcinoma, glioma, CRC, lung cancer, pancreatic cancer, and urothelial cancer. Higher levels
of TGF- /H9252expression are also positively correlated with poorer differentiation, advanced tumor
stages, and worse prognosis.
There are several possible mechanisms to inhibit the TGF- /H9252R1 signaling pathway,
including small molecule receptor kinase inhibitors, antibodies that bind to TGF- /H9252R1, ligand
traps that bind to TGF- /H9252R1, and latent TGF- /H9252R1. The inhibition of the TGF- /H9252signaling
pathway could potentially slow the tumor progression.
Competitive Landscape of TGF- /H9252R1-targeted Drug
As of the Latest Practicable Date, there was no approved TGF- /H9252R1 inhibitor globally, and
there were eight TGF- /H9252R1 inhibitor candidates under clinical development globally as of
Latest Practicable Date. The following table sets forth the clinical-stage TGF- /H9252R1 inhibitor
candidates globally.
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Pipeline of Clinical-stage TGF- /H9252R1 Inhibitor Drug Candidates Globally
Drug names Indication Latest
status Company Therapeutic strategy Treatment
Line
Route of
Administration
Treatment
Schedules Efficacy & Safety Country/
region
First posted
date
AGMB-129 Fibrostenotic Crohn's
disease Phase 2
Agomab
Therapeutics
Mono Not Applicable oral 200mg twice-daily
or 100mg QD –
US,
Italy, Canada,
etc.
2023-05-06
AGMB-447 Idiopathic pulmonary
fibrosis Phase 1 Mono Not Applicable inhaled
a single dose of
AGMB-447, multiple
doses of AGMB-447
over 7 days or multiple
doses of AGMB-447
over 14 days
– United Kingdom 2023-12-26
GFH018
Unresectable, locally
advanced stage III
NSCLC
Phase 2
Genfleet
Therapeutics
Combo with toripalimab and
concurrent chemoradiotherapy 1L
oral
80mg QD 7 day-
on/7 day-off +
Toripalimab
240mg Q3W +
chemotherapy
– China 2022-05-23
Advanced solid tumor Phase 1/2 Combo with toripalimab 2L+
GFH018 40/80mg
BID for  14 day-on/
14 day-off +
Toripalimab
3mg/kg Q2W
All r/m NPC pts:
ORR 26.1%,
mPFS 2.0 months,
DCR 43.5%
r/m NPC pts without
prior treatment of
ICIs: ORR 40%,
mPFS 9.0 months,
DCR 60%
China, Australia 2021-06-04
Advanced solid tumor Phase 1 Mono NA
5/10/20/30/40/50/65/
85 mg BID, 14 day-
on/14 day-off, 28-day
cycle or 85mg BID,
7 day-on/7 day-off
DCR 25.0%,
TRAE 86.0%,
TRAE (grade ≥3) 6%
China 2021-09-21
LY2157299
Metastatic castration-resistant
PC
Phase 2
Eli Lilly
MedPacto
Sanhome
Pharmaceutical
Combo with enzalutamide NA
oral
LY2157299 150mg
BID on 1-14 days
of each cycle +
Enzalutamide 160mg
QD on 1-28 days
of each cycle
– US 2015-05-22
advanced liver cancer mono or combo with Sorafenib NA 150mg BID
for 14 days CR 32% China 2015-07-10
Metastatic castration-resistant
PC Combo with enzalutamide 1L 150mg BID
for 14 days ORR 5%, SAE 30% US 2015-05-22
LY3200882 Solid Tumor Phase 1
Mono and combo with
LY3300054, Gemcitabine +
nab-Paclitaxel or Cisplatin +
Radiation
NA oral
oral
oral
50 mg BID 2-weeks-
on/2-weeks-off and
35 mg BID 3-weeks-
on/1-week-off
DCR 75%,
TEAE 93.5%,
TEAE (LY3200882-
related) 39.6%
US,
Italy, Canada,
etc.
2016-10-18
Vactosertib
Adolescents and adults with
recurrent, refractory or
progressive osteosarcoma
Phase 1/2 Mono 2L+
150/200/250mg BID,
5day-on/2day-off,
4-week cycle
– US, Korea 2022-10-20
SH3051 Advanced malignant
solid tumor Phase 1 Mono 1L+ 20/40/60/80/100mg BID,
28-day cycle – China 2020-03-27YL-13027
Metastatic PC Phase 1b/2
YingLi
Pharmaceutical
combo with chemotherapy,
with or without HY-0102 NA
oral
YL-13027 180mg
BID + Nab-paclitaxel
125mg/m
2, D1D8
D15 Q4W +
Gemcitabine
1000mg/m
2, D1D8
D15 Q4W ± HY-0102
10mg D1D15 Q4W
– China 2024-10-29
Advanced solid tumors Phase 1/2 Combo with sintilimab 1L+
YL-13027
240/360mg BID +
sintilimab 200mg
Q3W, 21-day cycle
– China 2022-07-14
Solid tumors Phase 1 Mono 1L+
start with initial
dose 60mg BID,
28-day cycle
TEAE (grade ≥3):
gamma-
glutamyltransferase
increased (7.7%),
haemoglobin
decreased (0%),
blood alkaline
phosphatase
increased (7.7%),
aspartate
aminotransferase
increased (0%) and
blood phosphorus
decreased (0%)
China 2019-06-14
Note: Ongoing Clinical trials with first posted date up to Latest Practicable Date, initiated by companies are
included.
Source: CDE, Clinical Trials, Frost & Sullivan Analysis
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The following table represents toripalimab approval timeline in China.
Approval Time Indication
2018/12 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Unresectable or metastatic melanoma that has failed previous
systemic therapy
2021/02 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Recurrent/metastatic nasopharyngeal carcinoma that has
failed second-line or above systemic treatment in the past
2021/04 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Failure of platinum-based chemotherapy, includes locally
advanced or metastatic urothelial carcinoma that progresses
within 12 months of neoadjuvant or adjuvant chemotherapy
2021/11 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118First-line treatment for recurrent/metastatic nasopharyngeal
carcinoma that has not received systemic therapy before
2022/05 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118In combination with platinum chemotherapy as first-line
treatment for locally advanced or metastatic esophageal
squamous cell
2022/09 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118In combination with pemetrexed and platinum for first-line
treatment of EGFR gene mutation negative and ALK
negative, unresectable locally advanced or metastatic non
squamous NSCLC
2024/01 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118In combination with chemotherapy perioperative and
monotherapy adjuvant therapy for resectable stage III
NSCLC patients
2024/04 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118In combination with axitinib for first-line treatment of
intermediate to high-risk unresectable or metastatic renal cell
carcinoma patients
2024/06 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118In combination with etoposide and platinum for first-line
treatment of extensive stage small cell lung cancer
(ES-SCLC)
2024/06 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118In combination with paclitaxel for injection (albumin binding
type) for first-line treatment of recurrent or metastatic triple
negative breast cancer (TNBC) with fully verified PD-L1
positive (CPS /H113501) detection
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Approval Time Indication
2025/03 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118In combination with bevacizumab for first-line treatment of
unresectable or metastatic hepatocellular carcinoma (HCC)
patients
2024/04 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118First-line treatment for unresectable or metastatic melanoma
Source: Frost & Sullivan analysis.
In China, toripalimab is priced at RMB812.88 fo ra2m L vial containing 80 mg.
REPORT COMMISSIONED BY FROST AND SULLIV AN
In connection with the Global Offering, we have engaged Frost & Sullivan to conduct a
detailed analysis and to prepare an industry report on the major markets for which our drug
candidates are positioned. Frost & Sullivan is an independent global market research and
consulting company founded in 1961 and is based in the United States. We have agreed to pay
Frost & Sullivan a total fee of approximately RMB0.7 million for the preparation of the Frost
& Sullivan Report, and we believe that such fee is consistent with the market rate. The payment
of such amount was not contingent upon our successful listing or on the content of the Frost
& Sullivan Report. Except for the Frost & Sullivan Report, we did not commission any other
industry report in connection with the Global Offering.
The market projections in the Frost & Sullivan Report were based on the following key
assumptions: (i) the overall social, economic and political environment globally and in China
is expected to remain stable during the forecast period; (ii) the economic and industrial
development globally and in China is likely to maintain a steady growth trend over the next
decade; (iii) related key industry drivers are likely to continue driving the growth of the market
during the forecast period; and (iv) there is no extreme force majeure or industry regulation in
which the market may be affected dramatically or fundamentally. The reliability of the Frost
& Sullivan Report may be affected by the accuracy of the foregoing key assumptions.,
including those used to make future projections, are factual, correct and not misleading.
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OVERVIEW OF LA WS AND REGULATIONS IN THE PRC
This section summarizes the principal PRC laws, rules and regulations relevant to our
business.
Pharmaceutical Regulatory System
Principal Regulatory Authorities
The major regulatory authorities of pharmaceutical industry in the PRC include the
National Medical Products Administration (the “ NMPA,” formerly known as the China Food
and Drug Administration (“ CFDA ”)), the National Health Commission (“ NHC,” formerly
known as the National Health and Family Planning Commission), and the National Healthcare
Security Administration.
The NMPA carries on responsibilities for pharmaceutical supervision of CFDA, its
predecessor, as the principal pharmaceutical regulatory authority in charge of the
pharmaceutical registration and supervision, including non-clinical research, clinical trial,
marketing approval, production and circulation.
The NHC is the chief healthcare regulator of the PRC, which is primarily responsible for
drafting national healthcare policies, regulating public health, medical services and health
contingency system, coordinating the implementation of healthcare reform and overseeing the
operation of medical institutions and practice of medical personnel.
The National Healthcare Security Administration (a new authority established in May,
2018 in accordance with the Institutional Reform Program of the State Council) is responsible
for drafting and implementing policies, plans and standards on medical insurance, maternity
insurance and medical assistance; administering healthcare fund; formulating a uniform
medical insurance catalogue and payment standards on drugs, medical consumables and
healthcare services; formulating and administering the bidding and tendering policies for drugs
and medical consumables.
Laws and Regulations Relating to Drugs
Drug Administration Laws and Regulations
The PRC Drug Administration Law () (the “ Drug
Administration Law ”) promulgated by the Standing Committee of the National People’s
Congress (the “ NPCSC ”) on September 20, 1984, and amended on February 28, 2001,
December 28, 2013, April 24, 2015, and August 26, 2019, as well as the Implementing Rules
for the PRC Drug Administration Law (ૢԷ) (the
“Implementing Rules for the Drug Administration Law ”) issued by the State Council on
August 4, 2002, and amended on February 6, 2016 and March 2, 2019 have together laid down
the legal framework for the administration of drugs, including the research, development,
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manufacturing and business operation for new drugs, and administer the pharmaceutical
manufacturing enterprises, pharmaceutical operating enterprises, and medicinal preparations of
medical institutions, along with the development, research, production, distribution,
packaging, pricing and advertisements of drugs.
Non-Clinical Research and Animal Testing
The SAMR requires preclinical data to support registration applications for imported and
domestic drugs. According to the Administrative Measures for Drug Registration (ൗ̅
), issued by the SAMR on January 22, 2020, and became effective on July 1, 2020,
non-clinical drug safety evaluation studies shall comply with the Good Laboratory Practice for
Non-clinical Laboratory Studies (Ӻሯඎ၍ଣ஝ᇍ) (the “ GLP”). The latest
GLP has been implemented by the CFDA since September 1, 2017, to improve the quality of
non-clinical research.
Pursuant to the Measures for Administration of Certification of the Good Laboratory
Practice for Non-clinical Laboratory Studies (Ӻሯඎ၍ଣ஝ᇍႩᗇ၍ଣ፬
) promulgated on January 19, 2023 and implemented since July 1, 2023 by the NMPA,
applying for the GLP certification is required for institutions that intend to conduct non-clinical
safety evaluation studies in the PRC used for drug registration applications. The NMPA is in
charge of the administration of the GLP certification nationwide, while the provincial medical
products administrative authorities are responsible for the daily supervision and administration
of non-clinical safety evaluation studies institutions within the administrative region. The GLP
Certificate will be issued by the NMPA with its approval if the relevant requirements for the
GLP are satisfied by the applicant. The valid period for the GLP certificate lasts for 5 years.
Any entity without such certification must engage a qualified third party to conduct such
non-clinical studies regulated under relevant laws and regulations.
Pursuant to the Administrative Regulations on Experimental Animals (၍ଣૢ
Է) issued by the State Science and Technology Commission on November 14, 1988, and
latest amended on March 1, 2017 by the State Council, the Administrative Measures on Good
Practice of Experimental Animals () jointly issued by the State
Science and Technology Commission and the State Bureau of Quality and Technical
Supervision on December 11, 1997, and the Administrative Measures on the Certificate for
Experimental Animals (Trial) (ج(༊Б)) issued by the Ministry of
Science and Technology and other regulatory authorities on December 5, 2001 and
implemented since January 1, 2002, using and breeding experimental animals shall be subject
to certain rules, and performing experiments on animals requires a Certificate for Use of
Experimental Animals. Any entity without such certification must engage a qualified third
party to conduct such non-clinical studies regulated under relevant laws and regulations.
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Approval of Clinical Trials
Pursuant to the Administrative Measures for Drug Registration, an applicant that applies
for a drug clinical trial after completion of the pharmaceutical, pharmacological and
toxicological research, etc., which support the drug clinical trial, shall submit relevant research
materials according to the requirements for application materials. The application materials
shall be accepted if they are deemed acceptable upon formal examination. The Center for Drug
Evaluation of the National Medical Products Administration (the “ CDE”) shall organize
pharmaceutical, medical and other technicians to review the accepted application for the drug
clinical trial. A decision on approval or non-approval of the application for clinical trials of
drugs shall be made within 60 days from acceptance of application, and the applicant shall be
notified of the examination and approval outcome through the CDE website; where the
applicant is not notified within the stipulated period, the application shall be deemed approved,
and the applicant may conduct clinical trial of drugs in accordance with the submitted scheme.
According to the Circular on Drug Clinical Trial Information Platform (ᑗґ
ʮѓ) issued by the CFDA on September 6, 2013, all clinical trials approved
by the NMPA and conducted in the PRC shall complete clinical trial registration and publish
trial information through the Drug Clinical Trial Public Information Platform. The applicant
shall complete the initial registration of the trial within one month after obtaining the approval
of the drug clinical trial to obtain an exclusive trial registration number and complete the
subsequent information registration before the first participant is enrolled in the trial.
Phases of Clinical Trials and Communication with the CDE
Pursuant to the Drug Administration Law (), drug clinical trials shall be
carried out in a clinical trial institution with corresponding conditions. The conditions that
clinical trial institution should satisfy shall mainly comply with the relevant requirements of
Administrative Regulations for Drug Clinical Trial Institutions (ᑗґ༊᜕ዚ࿴၍ଣ஝
), which came into effect on December 1, 2019. Such drug clinical trial institutions shall
be subject to filing administration. Institutions that only engage in analysis of biological
samples related to drug clinical trials shall not be subject to filing. The NMPA is responsible
for setting up a filing management information platform for drug clinical trial institutions for
registration, filing and operation management of drug clinical trial institutions, as well as the
entry, sharing and disclosure of information on supervision and inspection of the drug
regulatory authority and competent healthcare authority.
According to the Administrative Measures for Drug Registration, based on the drug’s
characteristics and the purpose of research, clinical trials of drugs consist of Phase I, II, III and
IV clinical trials, as well as the bioequivalence trials, contents of which include clinical
pharmacology research, exploratory clinical trials, confirmatory clinical trials and post-
marketing research. Clinical trials shall be conducted in accordance with the provisions of the
PRC GCP , including the preparation for clinical trials, clinical trial protocols, responsibilities
of sponsors and investigators, and protection of subjects, etc.
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Pursuant to the Administrative Measures for Communication on Drug Development and
Technical Reviews () issued by the CDE on
December 10, 2020, during the research and development, and application for registration
stages of innovative drugs, the applicant may propose communication sessions with the CDE.
The forms of communication can be face-to-face conference, video conference, telephone
conference or written replies. The communication sessions are classified into three types. Type
I sessions are held to address the material safety issues encountered in the clinical trials of
drugs and the significant technical issues in the research and development process of
breakthrough therapeutic drugs. Type II sessions are held during the key research and
development stages of drugs, mainly including the sessions held prior to the application of
IND, the sessions held upon completion of Phase II clinical trials and prior to commencement
of Phase III clinical trials of new drugs, the sessions held prior to application for marketing
approvals of new drugs, and the risk evaluation and control sessions. Type III sessions are
those sessions not falling into the categories of Type I or II sessions.
International Multi-Center Clinical Trial
Pursuant to the International Multi-Center Clinical Trial Guidelines (Trial) ( ਷ყεʕ
یܸ(༊Б)) issued by the CFDA on January 30, 2015 and effective from
March 1, 2015, applicants may simultaneously conduct clinical trials in different centers of
multiple regions using the same clinical trial protocol, or conduct regional clinical trials
simultaneously in multiple centers in different countries within a certain region using the same
protocol. Where the data derived from the international multi-center clinical trials are to be
used for application for a drug registration in the PRC, it shall satisfy the requirements for
clinical trials set forth in the Administrative Measures for Drug Registration. Where the
applicant plans to conduct the international multi-center clinical trials in the PRC, it shall
comply with the Drug Administration Law, the Implementing Rules for the Drug
Administration Law and the Administrative Measures for Drug Registration and other relevant
laws and regulations, to carry out the PRC GCP with reference to internationally recognized
principles such as the ICH-GCP , and to meet the requirements of the laws and regulations of
the relevant countries at the same time.
The NMPA issued the Technical Guiding Principles for the Acceptance of Overseas
Clinical Trial Data of Drugs () on July 6,
2018, to guide work related to the acceptance of overseas clinical trial data as clinical
evaluation reference by the applicant applying for the registration of drugs in the PRC.
Registration and Application of New Drugs
According to the Administrative Measures for Drug Registration, the drug registration
administration shall be categorized into traditional Chinese drugs, chemical drugs and
biological products; among them, the registration of chemical drugs shall be categorized into
innovative chemical drugs, improved new chemical drugs, generic chemical drugs, etc.
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Pursuant to the Reform Plan for Registration Category of Chemical Medicine ( ʷኪᖹ
) issued by the CFDA on March 4, 2016, new registration of
chemical drugs are divided into 5 categories: (i) Category 1: innovative drugs that have not
been marketed in the PRC or abroad which shall contain new compounds with clear structure
and pharmacological effects and clinical value; (ii) Category 2: improved new drugs that have
not been marketed in the PRC or abroad with optimization in structure, dosage form,
prescription technology, route of drug administration and indications on the basis of known
active ingredients as well as obvious clinical advantages; (iii) Category 3: drugs imitated by
domestic applicants which are marketed overseas while originator’s drugs are not marketed in
the PRC. Such drugs should possess quality and efficacy in line with that of the originator’s
drugs (i.e. the first drugs approved to be marketed in the PRC or overseas with complete and
sufficient safety and efficacy data to serve as the basis for its launch); (iv) Category 4: drugs
imitated by domestic applicants while originator’s drugs have been marketed in the PRC. The
quality and efficacy of such drugs should be consistent with that of the originator’s drugs; and
(v) Category 5: drugs which have been marketed abroad with the applications to be marketed
in the PRC. Among them, the reporting procedure for Category 1 and 2 shall comply with those
for new drugs and for Category 3 and 4 it shall be in accordance with those for generic drugs,
while Category 5 shall be reported pursuant to the procedures for imported drugs.
According to the Registration Classification of Chemical Drugs and the Reporting
Information Requirements (Ӌ) issued by the NMPA on
June 29, 2020 with implementation of the Registration Classification of Chemical Drugs from
July 1, 2020, the registration of chemical drugs is categorized into innovative drugs, improved
new drugs, generic drugs, and chemical drugs marketed abroad only. The Registration
Classification of Chemical Drugs and the Reporting Information Requirements reaffirmed the
classification principles for chemical drugs set forth by the Reform Plan for Registration
Classification of Chemical Drugs () and made further
adjustments to the chemical drugs subclassifications of Category 2 and 5 among which as well
as elaboration regarding the quality and efficacy requirements for generic drugs in Category 3
and 4; in addition, it is also proposed the registration requirements and reporting information
requirements for various types of chemical drugs.
According to the Administrative Measures for Drug Registration, the applicant may
submit an application for permission of the drugs registration for marketing (“ New Drug
Application ”) upon determining quality standards after completion of researches on pharmacy,
pharmacology, toxicology, and clinical trials of drugs that support the registration of drugs for
marketing and completing the commercial-scale production process verification and
preparations for receiving on-site inspections. The New Drug Application shall be evaluated by
the NMPA in accordance with applicable laws and regulations.
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Accelerated Approval for Clinical Trial and New Drug Registration
The Opinions of the State Council on the Reform of Evaluation and Approval System for
Drugs and Medical Devices (จԈ) issued
by the State Council on August 9, 2015, established a reform framework of the evaluation and
approval system for drugs and medical devices, and specified the tasks of enhancing the
standards of approval for, among others, drug registration, accelerating the evaluation and
approval process for innovative drugs, and improving the approval for clinical trials of drugs.
The Announcement on Several Policies on Drug Registration Review and Approval ( ᗫ
ʮѓ) issued by the CFDA on November 11, 2015, provided
fast-track clinical trial approvals and drug registration pathways for the following new drug
applications: (i) registration of innovative new drugs treating HIV , malignant tumors (cancers),
severe infectious diseases and rare diseases; (ii) registration of pediatric drugs; (iii) registration
of geriatric drugs and drugs treating diseases specially or commonly contracted by the senior
population; (iv) registration of drugs listed in national major science and technology projects
or national key research and development plan; (v) registration of innovative drugs using
advanced technology or innovative treatment methods, or having distinctive clinical benefits;
(vi) registration of foreign innovative drugs to be manufactured locally in China; (vii)
concurrent applications for new drug clinical trials which are already approved in the United
States or the European Union or concurrent drug registration applications for drugs which have
applied to the competent drug approval authorities for marketing authorization and passed such
authorities’ onsite inspections in the United States or European Union and are manufactured
using the same production line in China; and (viii) clinical trial applications for drugs with
urgent clinical need and patent expiry within three years, and manufacturing authorization
applications for drugs with urgent clinical need and patent expiry within one year.
On October 8, 2017, the General Office of the Central Committee of the Communist Party
of China and the General Office of the State Council jointly issued the Opinions on Deepening
the Reform of the Evaluation and Approval System and Encouraging Innovation of Drugs and
Medical Devices (จԈ), aiming to
simplify the clinical trial procedures and shorten the time. For new drugs and medical devices
urgently needed in clinical practice and drugs and medical devices used for the treatment of
rare diseases, the evaluation and approval procedures for marketing shall be accelerated.
Furthermore, according to the Announcement on Matters Concerning the Optimization of
Drug Registration Review and Approval (ʮѓ)
jointly issued by the NMPA and the NHC on May 17, 2018, the drug approval process shall be
further streamlined and expedited.
Pursuant to the provisions of the Procedures for the Evaluation of Breakthrough
Therapeutic Drugs (Trial) (ᄲ൙ʈЪ೻ҏ(༊Б)) issued by the NMPA on
July 7, 2020, during the clinical drug trials, the applicant is allowed to apply for the
breakthrough therapeutic drug procedure during Phase I and Phase II clinical trials and
normally no later than the commencement of Phase III clinical trials for the innovative or
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improved drugs etc. which are used for the prevention and treatment of diseases that seriously
endanger life or seriously affect quality of life and there is no effective means of prevention
and treatment or there is sufficient evidence to show a significant clinical advantage over
existing treatment approach.
The Administrative Measures for Drug Registration has integrated the previous reform in
respect of the accelerated approval for clinical trial and drug marketing registration and
introduced four procedures for expedited marketing registration of drugs, which are procedures
for breakthrough therapeutic drugs, procedures for conditional approval, procedures for
prioritized review and approval, and procedures for special examination and approval:
Procedures for breakthrough therapeutic drugs: during the drug clinical trials, for an
innovative drug or improved new drug used for prevention and treatment of life-threatening
illnesses or illnesses which have a serious impact on quality of life and for which there is no
other effective prevention and treatment method or there is adequate evidence to prove that the
said innovative drug or improved new drug has obvious clinical advantages over existing
treatment approach, the applicant may request for application of procedures for breakthrough
therapeutic drugs.
Procedures for conditional approval: during the drug clinical trials, for drugs which fall
under the following circumstances, an application for conditional approval of marketing
registration may be submitted (i) for drugs for treatment of life-threatening illnesses for which
there is no effective treatment approach, the clinical trial of drugs already has data to prove
efficacy and is able to forecast the clinical value; (ii) for drugs urgently needed for public
health, the clinical trial of drugs already has data to prove efficacy and is able to forecast the
clinical value; and (iii) for other vaccines urgently needed for major public health emergencies
or deemed by the NHC to be urgently needed, its benefits outweigh the risks according to the
evaluation.
Procedures for prioritized review and approval: at the time of the drug marketing
registration, drugs have obvious clinical value may apply for application of procedures for
prioritized review and approval, including (i) clinically and urgently needed but insufficient
drug, innovative drugs and improved new drugs for prevention and treatment of major
contagious diseases and rare diseases; (ii) new pharmaceutical product types, dosage form and
specifications of pediatric drugs which comply with pediatric physiological characteristics;
(iii) vaccines and innovative vaccines urgently needed for prevention and control of diseases;
(iv) drugs included in the procedures for breakthrough therapeutic drug; (v) drugs which
comply with conditional approval criteria; and (vi) other circumstances of prioritized review
promulgated by the NMPA.
Procedures for special examination and approval: at the time of a threat or occurrence of
public health emergency, the NMPA may, in accordance with law, decide to implement special
examination and approval for urgently needed drug required for the prevention and treatment
during the public health emergency.
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Marketing Authorization Holder System
Pursuant to Drug Administration Law, the drug marketing authorization holder system has
been implemented for drug management in the PRC. The drug marketing authorization holder
refers to an enterprise or a drug research and development institution that has obtained the drug
registration certificate, which is responsible for the safety, efficacy and controlled quality of
medicine during the whole process of drug development, production, operation and utilization
processes in accordance with laws. The marketing authorization holders shall be liable for
non-clinical study, clinical trial, manufacturing and business operation, post-market launch
study, monitoring, reporting and handling of adverse reactions of the pharmaceuticals. The
legal representative and the key person-in-charge of a drug marketing authorization holder
shall be fully responsible for the quality of drugs.
The drug marketing authorization holders may produce drugs by themselves or entrust
drug manufacturers with the production of such drugs; they may sell drugs with a drug
registration permit on their own or through entrusting qualified drug operating enterprises.
Blood products, anesthetics, psychotropic drugs, toxic drugs for medical use and
pharmaceutical precursor chemicals are in principle not allowed to be produced through
entrustment.
The drug marketing authorization holders shall establish a pharmaceutical quality
assurance system, equipped with specialized staff solely responsible for the management of
drug quality; the drug marketing authorization holders shall regularly review the quality
management system of the drug manufacturer and the drug distributor, and supervise their
continuous quality assurance and control capabilities. The drug marketing authorization
holders, drug manufacturers, drug distributors and medical institutions shall establish and
implement a drug traceability system, provide traceability information in accordance with
regulations and ensure that drugs are traceable.
Pharmacovigilance
Pursuant to the Pharmacovigilance Quality Control Specifications (ᙆҡሯඎ၍ଣ
஝ᇍ) issued by the NMPA on May 7, 2021, and implemented from December 1, 2021, drug
marketing authorization holders and drug registration applicants who are permitted to
implement drug clinical trials shall establish the pharmacovigilance system to monitor,
identify, evaluate and control adverse drug reactions and other drug-related harmful reactions
through the effective operation and maintenance of the system. The drug marketing
authorization holders shall initiate quality objectives for pharmacovigilance and establish
quality assurance system for quality management on pharmacovigilance system and activities
with an aim to consistently improve the efficiency of the system and ensure the compliance of
the activities with the relevant laws and regulations. The legal representative and the key
person-in-charge of a drug marketing authorization holder shall be fully responsible for the
pharmacovigilance activities. The drug marketing authorization holders shall complete the
information registration in the National Adverse Drug Reaction Monitoring System within 30
days upon the date of obtaining the first drug approval document.
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Filing for Gathering and Collection of Human Genetic Resources
Pursuant to the Service Guide for Administrative Licensing of Gathering, Collection,
Deal, Export and Exit Approval of Human Genetic Resources of Human Genetic Resources
() promulgated
by the Ministry of Science and Technology on July 2, 2015, the sampling, collection or
research activities of human genetic resources by a foreign-invested sponsor fall within the
scope of international cooperation, and the cooperating organization of China shall apply for
approval of the China Human Genetic Resources Management Office through the online
system. The Ministry of Science and Technology promulgated the Circular on Optimizing the
Administrative Examination and Approval of Human Genetic Resources (Ꮄʷɛᗳ፲ෂ
) on October 26, 2017, which became effective on December 1,
2017, simplifying the approval of sampling and collecting human genetic resources for the
purpose of marketing a drug in the PRC.
According to the Regulation of the People’s Republic of China on the Management of
Human Genetic Resources ( ʕശɛ͏΍ձ਷ɛᗳ፲ෂ༟๕၍ଣૢԷ), as promulgated by
the State Council on May 28, 2019, effective on July 1, 2019, and revised on March 10, 2024,
in order to obtain marketing authorization for relevant drugs and medical devices in China, no
approval is required in international clinical trial cooperation using China’s human genetic
resources at clinical institutions without export of human genetic resources materials.
However, the two parties should file the type, quantity and usage of the human genetic
resources to be used with the competent health department under the State Council before
clinical trials. On May 26, 2023, the Ministry of Science and Technology issued the
Implementing Rules of the Administrative Regulations on Human Genetic Resources ( ɛᗳ
), which became effective from July 1, 2023, further specifying
the requirements for the collection, preservation, use, and outbound offering of the human
genetic resources in the PRC.
On October 17, 2020, the NPCSC promulgated the Biosecurity Law of the PRC ( ʕശ
) (the “ Biosecurity Law ”) which became effective on April 15, 2021
and was revised on April 26, 2024, establishing a comprehensive legislative framework on the
current regulations in the areas including epidemic control of human, animal and plant
infectious diseases, security of biotechnology research, development and application, biosafety
management of pathogenic microbiology laboratories, security management of human genetic
resources and biological resources, countermeasures against microbial resistance and
prevention of bioterrorism and threat of biological weapons. According to the Biosecurity Law,
the high-risk and medium-risk biotechnology research and development activities shall be
carried out by legal entities lawfully established in the PRC, and shall be approved or filed; the
establishment of a pathogenic microbiology laboratory shall be lawfully approved or filed; the
approval from the competent health department under the State Council is required for the
following activities: (i) collecting human genetic resources of important genetic families or
specific areas in the PRC, or collecting human genetic resources of which the types and
quantities are subject to provisions of the competent health department under the State Council,
(ii) preserving human genetic resources of the PRC, (iii) using human genetic resources of the
PRC to carry out international scientific research cooperation, or (iv) transporting, mailing or
exiting human genetic resource materials of the PRC.
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Drug Manufacturing License
According to the Drug Administration Law and the Implementing Rules for the Drug
Administration Law, when engaging in pharmaceutical manufacturing activities, an enterprise
must obtain a Drug Manufacturing License (͛ପ஢̙ᗇ) granted by the drug regulatory
authority of the people’s government of the province, autonomous region, or municipality
directly under the central government at the place where the enterprise is located. No medicinal
products shall be manufactured without a Drug Manufacturing License. The drug regulatory
authority of the people’s government of the province, autonomous region, or municipality
directly under the central government shall organize acceptance inspection for an enterprise
subject to the following conditions, and issue a drug manufacturing license if the acceptance
inspection is passed: (i) it shall be staffed with legally certified pharmaceutical technical
personnel, engineering technical personnel, as well as corresponding skilled workers; (ii) it
shall have factory premises, facilities and a sanitary environment suitable for the drugs
produced; (iii) it shall have institutions and personnel capable of managing and inspecting the
quality of the drugs produced, as well as necessary instruments and equipment; and (iv) it shall
have rules and regulations to ensure the quality of drugs. Each Drug Manufacturing License is
valid for a period of five years. If an enterprise holding the Drug Manufacturing License needs
to continue the manufacturing of drugs upon the expiration of the license, the enterprise should
apply for renewal in compliance with the regulation of the drug regulatory authority under the
State Council six months prior to the expiration of the license.
GMP
The Good Manufacturing Practices (͛ପሯඎ၍ଣ஝ᇍ) (GMP) was first
promulgated on March 17, 1988, subsequently revised on December 28, 1992, by the Ministry
of Health. After the establishment of the NMPA, the GMP was amended on June 18, 1999 and
became effective on August 1, 1999. The GMP , which was amended by the Ministry of Health
on January 17, 2011 and became effective on March 1, 2011, stipulates the basic standards for
pharmaceutical production which cover various areas including production plants and
facilities, qualification of management personnel, documentation, material packaging and
labeling, testing, production management, sales and return of products, and complaints of
customers.
On August 2, 2011, the CFDA issued the Circular on Printing and Distributing the
Administrative Measures for the Certification of Good Manufacturing Practice (Ι೯ᖹ
), which provided that newly established drug
manufacturers, or existing drug manufacturers that wish to expand manufacturing scope or
build new workshops shall apply for the GMP certification in accordance with the
Implementing Rules for the Drug Administration Law. Those drug manufacturers that have
already obtained the GMP certificates shall re-apply for the GMP certification within six
months prior to the expiration date of the GMP certificates. On December 30, 2015, the CFDA
issued the Notice on Effectively Implementing the Good Manufacturing Practice (ʲྼ
), which provided that those drug
manufacturers that failed to obtain the GMP certificates shall not be granted the drug
manufacturing license.
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On November 29, 2019, the NMPA issued the Announcement on Matters relating to the
Implementation of the Drug Administration Law of the PRC (݄<ʕശɛ͏΍ձ
ج>ʮѓ), which confirmed that the GMP certification would be
canceled from December 1, 2019, and no application for GMP certification would be accepted
and no GMP certificate would be granted. However, according to the Drug Administrative Law,
drug manufacturers shall still comply with the GMP , establish and improve the GMP system,
and ensure the whole drug production process is consistently in compliance with statutory
requirements.
The Administrative Measures for Drug Inspection (Trial) (ج(༊Б))
issued by the NMPA on May 24, 2021, and revised on July 19, 2023, and the Administrative
Measures for the Certification of Good Manufacturing Practice was repealed. The
Administrative Measures for Drug Inspection (Trial) provided that onsite inspections shall be
conducted pursuant to the GMP on a drug manufacturer applying for the Drug Manufacturing
License for the first time, while for the drug manufacturers applying for the renewal of Drug
Manufacturing License, the review shall be conducted based on the risk management
principles, in combination with the drug manufacturers’ compliance with the laws and
regulations of drug administration, and the operation of the GMP and quality management
system, and inspections on the drug manufacturers’ conformity to the GMP may be conducted
where necessary.
Entrusted Manufacturing of Drugs
Pursuant to the Measures on the Supervision and Administration of the Manufacture of
Drugs (), promulgated by the State Administration for Market
Regulation on December 11, 2002, with latest amendments on January 22, 2020 effective from
July 1, 2020, the drug marketing authorization holders may entrust qualified drug
manufacturing enterprises with drug production, provided that they shall evaluate the entrusted
party’s quality assurance capabilities and risk management capabilities. They shall also sign
the quality agreement and the entrustment agreement with the entrusted party in accordance
with the requirements of the guidelines for entrusted drug production promulgated by the
NMPA and supervise the fulfillment of the obligations agreed by the entrusted party in the
agreement; the entrusted party shall not recommission the production of the drugs it agreed to
be entrusted to another third party. The drug marketing authorization holders shall establish a
pharmaceutical quality assurance system, equipped with specialized staff solely responsible for
the quality of medicines management. They shall regularly review the quality management
system of the drug manufacturer and the drug distributor and supervise its continuous quality
assurance and control capabilities.
Drug Operation License
According to the Drug Administration Law, the Measures for the Supervision and
Administration of Drug Quality in Operation and Usage (຾ᐄձԴ͜ሯඎ္ຖ၍ଣ፬
), which was issued by the SAMR on September 27, 2023 and came into effect on January
1, 2024, whoever engages in the wholesale or retail of drugs shall be subject to the approval
of the drug regulatory authority, obtain a Drug Operation License in accordance with the law.
The drug marketing authorization holders may sell the drugs for which they have obtained drug
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registration certificate on their own or entrust a drug operating enterprise with the sale of such
drugs. However, the drug marketing authorization holders engaged in retail activities of drugs
shall obtain a Drug Operation License. Each Drug Operation License is valid for five years.
Where it is necessary to continue the operation of drugs upon the expiration of the period of
validity of the Drug Operation License, a drug operating enterprise shall file an application
with the license-issuing organ for re-examination and issuance of license in 6 to 2 months
before the expiration of the period of validity.
Other Relevant Regulations in the PRC Pharmaceutical Industry
Coverage of the National Medical Insurance Program
The national medical insurance program was first adopted according to the Decision of
the State Council on the Establishment of the Urban Employee Basic Medical Insurance
Program () issued by the State Council
on December 14, 1998, under which all employers in urban cities are required to enroll their
employees in the basic medical insurance program and the insurance premium is jointly
contributed by the employers and employees. On July 10, 2007, the State Council issued the
Guiding Opinions of the State Council about the Pilot Urban Resident Basic Medical Insurance
(ኬจԈ), further enlarged the coverage
of the basic medical insurance program, under which urban residents of the pilot district, rather
than urban employees, may voluntarily join the Urban Resident Basic Medical Insurance. In
addition, on January 3, 2016, the Opinions on Integrating the Basic Medical Insurance Systems
for Urban and Rural Residents (จԈ)
issued by the State Council required the integration of the urban resident basic medical
insurance and the new rural cooperative medical care system and the establishment of a unified
basic medical insurance system, which will cover all urban and rural residents other than rural
migrant workers and persons in flexible employment arrangements who participate in the basic
medical insurance for urban employees.
Pursuant to Interim Measures for the Administration of Drug Use in Basic Medical
Insurance () issued by the National Healthcare Security
Administration on July 30, 2020, and became effective on September 1, 2020, the scope of
medical insurance coverage for pharmaceutical products needs to be managed through the
formulation of the Medical Insurance Catalogue (ͦ፽), the cost of
drugs falls under which shall be paid by the Basic Medical Insurance Fund in accordance with
regulations in the PRC. The pharmaceutical products listed in the PRC Medical Insurance
Catalogue shall be chemical drugs, biological products, traditional Chinese drugs (including
ethnic drugs) and Chinese medicine decoction pieces prepared according to national standards,
all of which shall be clinically needed, safe and effective, and reasonably priced, with approval
from the drug administration department in the PRC and obtainment of drug registration
certificates. The administrative department of medical insurance under the State Council
established and improved the dynamic adjustment mechanism so that the Medical Insurance
Catalogue shall be adjusted once a year in principle. On the premise of meeting clinical needs,
the medical insurance designated medical institutions are required to prioritize the preparation
and utilization of drugs listed in the Medical Insurance Catalogue.
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Pursuant to Interim Measures for the Administration of Drug Use in Basic Medical
Insurance, expenses incurred by insured persons using drugs listed in the Medical Insurance
Catalogue may be paid by the Basic Medical Insurance Fund with satisfaction of the following:
(i) they are for the purpose of diagnosis or treatment of diseases; (ii) the diagnosis and
treatment are in line with their conditions, the legal indications of the drugs, and the limited
payment scope of the medical insurance; (iii) they are supplied by the designated medical
institutions in compliance with the regulations, except for emergency and rescue medicines;
(iv) the drug expenses paid by the unified fund shall be based on prescriptions from physicians
or hospitalization instructions; (v) they are examined by pharmacists or licensed pharmacists
through the prescribed procedures. Western medicines and traditional Chinese drugs are
divided into “Class A drugs” and “Class B drugs.” The use of “Class A drugs” is paid for by
the insured according to the payment standards and sharing methods stipulated by the basic
medical insurance; the use of “Class B drugs” is paid for according to the payment standards
stipulated by the basic medical insurance, with a certain percentage paid out of pocket by the
insured first, and then paid for according to the sharing methods stipulated by the basic medical
insurance. The proportion of out-of-pocket payments for “Class B drugs” is determined by the
administrative department of medical insurance in provinces or regions subject to its overall
planning.
National Essential Drug List
According to the Circular on the Printing and Distribution of the Administrative Measures
for the National Essential Drug List () issued
on February 13, 2015, the Opinions of the General Office of the State Council on Improving
the National Essential Drugs System (จԈ)
issued on September 13, 2018 and the National Essential Drug List (2018 version) (ਿ
ͦ፽(2018و)) (the “ National Essential Drug List ”) issued by the NHC on
September 30, 2018 and effective from November 1, 2018, basic healthcare institutions funded
by the government, which primarily include county-level hospitals, county-level Chinese
medicine hospitals, rural clinics and community clinics, shall store up and use drugs listed in
the National Essential Drug List. The drugs listed in the National Essential Drug List shall be
purchased by centralized tender process and shall be subject to the price control by the National
Development and Reform Commission (the “ NDRC ”). Remedial drugs listed in the National
Essential Drug List are all listed in the Medical Insurance Catalogue and the entire amount of
the purchase price of such drugs is entitled to reimbursement.
Centralized Procurement of Drugs
According to the Certain Regulations on the Trial Implementation of Centralized Tender
Procurement of Drug by Medical Institutions (ʍ஝
) jointly issued by authorities including the MOH on July 7, 2000, and the Notice on
Further Improvement on the Implementation of Centralized Tender Procurement of Drugs by
Medical Institutions () jointly
issued by authorities including the MOH on July 23, 2001, non-profit medical institutions run
by the people’s governments at county level and above are required to implement centralized
tender procurement of drugs. Drugs included in the drug catalogue of basic medical insurance
for urban employees (or publicly-funded medical care) and those with relatively high clinical
usage in medical institutions are, in principle, subject to centralized tender procurement.
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The Opinions on Further Regulating Centralized Procurement of Drugs by Medical
Institutions (จԈ) was jointly issued by
authorities including the MOH on January 17, 2009, according to which, the centralized
procurement of drugs for medical institutions shall be organized on a provincial (regional and
municipal) basis. Non-profit medical institutions owned by the people’s governments at county
level and above or owned by state-owned enterprises (including state-controlled enterprises)
must purchase pharmaceutical products by centralized procurement; other medical institutions
are encouraged to participate in the centralized procurement of drugs. The centralized
procurement of drugs should give full consideration to the characteristics of the clinical
demand for drugs at all levels and in all types of medical institutions, and the centralized
procurement cycle should be once a year in principle. Each provincial (regional and municipal)
government shall formulate its catalogue of drugs subject to centralized procurement. Drugs
included in the National Essential Drug List are implemented in accordance with the provisions
of the national essential drugs system. A few varieties of drugs under special management by
the State, such as Class II psychotropic drugs, toxic drugs for medical use and
radiopharmaceuticals, as well as Chinese herbal drugs and Chinese medicine decoction pieces,
are not be included in the catalogue for the centralized procurement of drugs, and narcotic
drugs and Class I psychotropic drugs are not included in the catalogue for the centralized
procurement of drugs. Except for the above drugs, all other drugs used by medical institutions
must, in principle, be included in the centralized procurement catalogue.
According to the Guiding Opinions on Enhancing Centralized Procurement of
Pharmaceutical Products by Public Hospitals (ණʕમ
ኬจԈ) issued by the General Office of the State Council on February 9, 2015,
the centralized procurement of drugs is carried out by categories: (i) for essential drugs and
non-patented drugs with large clinical usage, high procurement amounts and produced by
multiple enterprises, the advantages of provincial centralized bulk procurement are brought
into play, and the provincial drug procurement agency adopts the two-envelope system of open
tendering and procurement, and hospitals, as the main procurement body, purchase the drugs
according to the winning bid prices; (ii) for some patented drugs and exclusively produced
drugs, an open and transparent price negotiation mechanism with multi-party participation will
be established, and the results of the negotiation will be announced on the National Drug
Supply Security Comprehensive Management Information Platform, and the hospitals will
purchase the drugs according to the results of the negotiation; (iii) for generic drugs for women
and children, emergency (rescue) drugs, basic infusion, drugs with small clinical usage (the
specific scope of the above drugs is determined by provinces, autonomous regions and
municipalities) and commonly used low-priced drugs, centralized online bidding is
implemented and hospitals can directly procure them; (iv) for drugs that are clinically
necessary, in small quantities and in short supply in the market, the State will invite tenders for
designated production and purchase at negotiated prices; (v) for narcotic medicines,
psychotropic medicines, free medicines for the prevention and treatment of infectious and
parasitic diseases, vaccines under the National Immunization Program, medicines for planned
parenthood, and Chinese medicinal tablets, they shall be purchased in accordance with the
existing state regulations.
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According to the Opinions of the General Office of the State Council on Further Reform
and Improvement of Policy on Drug Production, Circulation and Use (ආ
ʍจԈ) promulgated by the General Office of the
State Council on January 24, 2017, cross-regional and specialized hospitals are encouraged to
make joint purchases; in areas where the reform of the payment method of health insurance is
comprehensively implemented or where the payment standard for drugs under health insurance
has already been formulated, public hospitals are allowed to jointly carry out volume- and
budget-based procurement on the provincial centralized drug procurement platform (the
provincial public resources trading platform).
According to the Pilot Program of the Centralized Procurement and Use of Drugs
Organized by the State () issued by the General
Office of the State Council on January 1, 2019, eleven pilot cities including Beijing, Tianjin,
Shanghai, Chongqing, Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu and Xi’an,
are selected to launch pilot programs of the centralized procurement and use of drugs under the
organization of the State. According to the Implementation Opinions on Expanding the
Regional Scope in the Pilot Program of Centralized Drug Procurement and Use Organized by
the State (จԈ) issued by the
National Healthcare Security Administration and other departments on September 25, 2019, the
regional scope in the pilot program of centralized procurement and use of drugs organized by
the State is being expanded and the volume-based procurement model of the pilot program for
conducting the centralized procurement and use of drugs organized by the State is being
promoted throughout the country.
The Opinions of the General Office of the State Council on Promoting the Centralized
V olume-based Procurement of Drugs in a Normalized and Institutionalized Manner ( ਷ਕ৫
จԈ), which was promulgated
by the General Office of the State Council on January 22, 2021, set out the promotion of the
normalization and institutionalization of the centralized procurement of drugs. All public
medical institutions (including military medical institutions, hereinafter referred to as the
same) shall participate in the centralized procurement of drugs, with reference to the
requirements of the management of designated social medical institutions and designated
pharmacies in accordance with the management of designated agreements for medical
insurance. In accordance with the principles of preserving the basics and the clinical care,
emphasis shall be placed on including drugs that are listed in the Drug Catalogue of Basic
Medical Insurance with large consumption and high procurement price in the procurement
scope, and gradually covering various drugs which are clinically necessary and reliable, so as
to achieve the procurement of all medicines as much as possible.
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Drug Price Management
Pursuant to the Opinions on Promoting Drug Pricing Reform (จ
Ԉ), which was jointly promulgated by the authorities including the NDRC on May 4, 2015,
from June 1, 2015, the original prices of the drugs formulated by the government will be
canceled, except for narcotic drugs and Class I psychotropic drugs. The prices of narcotic drugs
and Class I psychotropic drugs are still temporarily managed by the NDRC through the
implementation of maximum factory prices and maximum retail prices. The drugs other than
the narcotic drugs and Class I psychotropic drugs no longer adopted government-designated
pricing. Such notice aimed to improve the mechanism of the drug purchase, give play to the
role of health care insurance in drug fees controlling, and actual transaction prices of the drugs
are mainly determined by the market competition.
Two-invoice System
Pursuant to the 2016 Key Tasks for Deepening the Reform of the Pharmaceutical and
Healthcare System (ࠧ2016ᓃʈЪ΂ਕ) issued by the General
Office of the State Council on April 21, 2016, in order to optimize the order of purchasing and
selling pharmaceutical products and reduce circulation steps, the implementation of the
“two-invoice system” shall be constructed throughout the pilot provinces for comprehensive
healthcare reform and actively encouraged in the public hospitals of the pilot cities therefor.
According to the Opinions on the Implementation of the “Two Invoice System” in Drug
Procurement by Public Medical Institutions (for Trial Implementation) (ίʮͭᔼᐕዚ
મᒅʕપБ“ՇୃՓ”จԈ(༊Б)) issued by Deepen Medical and Healthcare
System Reform Leading Group Office (܃of the State
Council on December 26, 2016, the “Two Invoice System” refers to the system that requires
one invoice to be issued from pharmaceutical manufacturers to pharmaceutical distributors and
the other invoice to be issued from pharmaceutical distributors to medical institutions. The
wholly-owned or holding commercial company (only one commercial company is permitted in
the whole country) with the sales of its own enterprise (group) drugs only and the domestic
general agent for overseas drugs (only one domestic agent is permitted in the whole country)
established by a pharmaceutical manufacturer or a group enterprise integrating science,
industry and trade may be regarded as a manufacturer. The allocation of drugs between a
pharmaceutical distribution group enterprise and its wholly-owned (holding) subsidiaries or
among its wholly-owned (holding) subsidiaries may not be regarded as a process for which an
invoice should be issued, but one invoice is allowed to be issued at most. The gradual
implementation of the “Two Invoice System” in drug procurement by public medical
institutions would be encouragement for its implementation in the drug procurement for other
medical institutions.
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Other Significant PRC Regulations Affecting Our Business Activities in the PRC
Laws and Regulations relating to Company Law and Foreign Investment
The establishment, operation and management of enterprises in the PRC are governed by
the Company Law of the PRC () (the “ Company Law ”), which
was promulgated by the NPCSC on December 29, 1993 and became effective on July 1, 1994.
It was subsequently amended on December 25, 1999, August 28, 2004, October 27, 2005,
December 28, 2013, October 26, 2018, and December 29, 2023, respectively. Pursuant to the
Company Law, companies are classified into two categories, namely limited liability
companies and limited companies by shares. The Company Law shall also apply to
foreign-invested limited liability companies and companies limited by shares. According to the
Company Law, the provisions otherwise prescribed by the laws on foreign investment shall
prevail.
On March 15, 2019, the National People’s Congress (the “ NPC”) issued the Foreign
Investment Law of the People’s Republic of China () (the
“Foreign Investment Law ”), which came into effect on January 1, 2020 and the Sino-Foreign
Equity Joint V enture Enterprise Law of the People’s Republic of China ( ʕശɛ͏΍ձ਷ʕ
), the Wholly Foreign-Invested Enterprise Law of the People’s Republic
of China (), and the Cooperative Joint V enture Enterprise Law
of the People’s Republic of China () were simultaneously
abolished. Since then, the Foreign Investment Law has become the basic law regulating
foreign-invested enterprises wholly or partially invested by foreign investors. According to the
Foreign Investment Law and the Implementation Regulations for the Foreign Investment Law
of the PRC (ૢԷ) issued by the State Council on
December 26, 2019, with effect from January 1, 2020, “foreign investment” refers to the
investment activities in the PRC carried out directly or indirectly by foreign individuals,
enterprises or other organizations (the “ Foreign Investors ”), including the following: (i)
Foreign Investors establishing foreign-invested enterprises in the PRC alone or collectively
with other investors; (ii) Foreign Investors obtaining shares, equities, shares of properties or
other similar equities of Chinese domestic enterprises; (iii) Foreign Investors investing in new
projects in the PRC alone or collectively with other investors; (iv) Foreign Investors investing
through other ways prescribed by laws and regulations or the State Council. The provisions of
the Company Law, the Partnership Enterprise Law of the People’s Republic of China ( ʕശ
) and other laws shall apply to the form of organization of a
foreign-invested enterprise, its organizational structure and the rules governing its activities.
The PRC implements a pre-access national treatment plus negative list management
system for foreign investment, which means that foreign investors and their investments are
given treatment no less favorable than that accorded to domestic investors and their
investments at the stage of investment access; while the “negative list” refers to special
administrative measures for access of foreign investment in specific fields as stipulated by the
PRC. The national treatment shall be granted to foreign investments outside of the negative list.
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The Measures on Reporting Foreign Investment Information (జѓ፬
) was issued by MOFCOM and State Administration for Market Regulation on December
30, 2019 and came into effect on January 1, 2020, pursuant to which, for foreign investors
carrying out investment activities directly or indirectly in the PRC, the foreign investors or
foreign-invested enterprises shall submit investment information to the commerce authorities
pursuant to such measures. When submitting an annual report, a foreign-invested enterprise
shall submit the information such as basic enterprise information, the information on investor
and actual controller thereof, enterprise business operation, assets and liability, as well as the
relevant industry license information, if any special administrative measure for foreign
investment access is involved.
Laws and Regulations on Outbound Investment
Pursuant to the Administrative Measures on Outbound Investments ( ྤ̮ҳ༟၍ଣ፬
) issued by the MOFCOM on March 16, 2009, and amended on September 6, 2014, and
the Administrative Measures for the Outbound Investments of Enterprises ( Άุྤ̮ҳ༟၍
) issued by the NDRC on December 26, 2017, and effective from March 1, 2018, if
an enterprise in the PRC intends to make outbound investments, it shall be subject to approval
or filing for the project, report relevant information, and cooperate in the supervisory
inspections. Non-sensitive projects directly conducted by domestic enterprise in China,
involving direct contribution of assets or rights and interests or provision of financing or
security, shall be subject to filing.
Laws and Regulations relating to Foreign Exchange
The principal law governing foreign currency exchange in the PRC is the Foreign
Exchange Administration Regulations of the PRC ( ʕശɛ͏΍ձ਷̮ි၍ଣૢԷ) (the
“Foreign Exchange Administration Regulations ”). The Foreign Exchange Administration
Regulations were enacted by the State Council on January 29, 1996 and implemented on April
1, 1996. On January 14, 1997 and August 5, 2008, the State Council amended the Foreign
Exchange Administration Regulations. According to the Foreign Exchange Administration
Regulations, international payments in foreign currencies and transfer of foreign currencies
under current items shall not be restricted. Foreign currency transactions under the capital
account are still subject to limitations and require approvals from, or registration with, the
State Administration of Foreign Exchange of the PRC ( ʕശɛ͏΍ձ਷̮ි၍ଣᐼ҅) (the
“SAFE ”) or its local counterpart and other relevant PRC governmental authorities.
According to the Notice of the State Administration of Foreign Exchange on Issues
Concerning the Foreign Exchange Administration of Overseas Listing (׵
) issued by the SAFE and implemented on December 26,
2014, a domestic company shall, within 15 business days from the date of the end of its
overseas listing issuance, register the overseas listing with the local Foreign Exchange
Administration at the place of its establishment. The proceeds from an overseas listing of a
domestic company may be remitted to the domestic account or deposited in an overseas
account, but the use of the proceeds shall be consistent with the content of the prospectus or
company securities offering documents, circulars of the shareholders, resolutions from the
Board of Directors or at the shareholders’ meetings, and other disclosure documents.
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According to the Circular of SAFE on Reforming and Regulating Policies on the Control
over Foreign Exchange Settlement of Capital Accounts (ձ஝ᇍ༟
) (the “ SAFE Circular 16 ”) promulgated on June 9, 2016, and
revised on December 4, 2023, by the SAFE, the Discretional Foreign Exchange Settlement
shall be unified for all the domestic institutions, while the use of foreign exchange incomes of
capital projects by domestic institutions shall follow the principles of authenticity and self-use
within the business scope of enterprises. The SAFE Circular 16 stipulates that the foreign
exchange proceeds under the capital account of and the Renminbi funds obtained from foreign
exchange settlement by a domestic institution may be used for expenditures under the current
account within its business scope or the expenditures under the capital account permitted by
the laws and regulations. The foreign exchange proceeds under the capital account of and the
Renminbi funds obtained from foreign exchange settlement by a domestic institution (i) shall
not be used directly or indirectly for expenditures beyond the business scope of the domestic
institution or as prohibited by the laws and regulations; (ii) unless otherwise provided, shall not
be used directly or indirectly for securities investments or other investments (except for wealth
management products and structured deposits with risk rating not higher than level 2); (iii)
shall not be used for offering loans to non-affiliated enterprises, unless expressly permitted by
the business scope; (iv) shall not be used for the purchase of residential real estate not for
self-use (except for enterprises engaged in real estate development and real estate leasing).
According to the Circular of SAFE on Optimizing Foreign Exchange Administration to
Support the Development of Foreign-related Business (Ꮄʷ̮ි၍ଣ˕
) promulgated by the SAFE on April 10, 2020, the reform of
facilitating the payments of incomes under the capital projects shall be promoted nationwide.
Under the prerequisite of ensuring true and compliant use of funds and complying with the
prevailing administrative provisions on use of income from capital projects, enterprises which
satisfy the criteria are allowed to use income under the capital account, including capital funds,
foreign debt and overseas listing, for domestic payment, without the need to provide proof
materials for veracity to the bank beforehand for each transaction.
Distribution of Dividends
Pursuant to the provisions of the Company Law, when distributing each year’s profits
after taxation, the company shall set aside 10% of its profits for the company’s statutory
common reserve fund until the fund has reached more than 50% of the company’s registered
capital. When the company’s statutory common reserve fund is not sufficient to make up for
the company’s losses for the previous years, the current year’s profits shall first be used to
make good the losses before any allocation is set aside for the statutory common reserve fund.
After the company has made allocations to the statutory common reserve fund from its profits
after taxation, it may, upon the resolution at a shareholders’ general meeting, make further
allocations from its profits after taxation to the discretionary common reserve fund. After the
company has made good its losses and made allocations to its common reserve fund, the
remaining profits after taxation shall be distributed to the shareholders.
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On January 26, 2017, the SAFE issued the Notice on Promoting the Reform of Foreign
Exchange Administration and Improving the Review of Authenticity and Compliance (׵
) which provided that when processing
the outward remittance of profits of a domestic institution equivalent to more than 50,000 US
dollars, the bank shall, in light of the principle of genuine transaction, review the profit
distribution resolution made by the board of directors (or by the partners), original tax filing
form and audited financial statements relating to the outward remittance of profits, and chop
on the original tax filing form to endorse the amount and date of the outward remittance. The
domestic institution shall make up for its losses during the previous years according to the laws
before remitting the profits.
Laws and Regulations Related to Intellectual Property Rights
Patents
Pursuant to the Patent Law of the PRC () (the “ Patent Law ”)
promulgated by the NPCSC on March 12, 1984, and amended on September 4, 1992, August
25, 2000 December 27, 2008, and October 17, 2020, respectively, with the latest amendments
effective from June 1, 2021, and the Implementation Rules of the Patent Law of the PRC ( ʕ
) promulgated by the State Council on June 15, 2001, with the
latest amendments on December 11, 2023, effective from January 20, 2024, the patents in the
PRC refer to invention, utility model and design. An invention or a utility model to be granted
as a patent shall have novelty, creativity and practicality. The Patent Office under the State
Intellectual Property Office is responsible for receiving, examining, and approving patent
applications. A patent is valid for a twenty-year term for an invention, a ten-year term for a
utility model, or a fifteen-year term for a design, commencing from their respective application
dates.
According to the provisions of the Patent Law and the Implementation Rules of the Patent
Law of the PRC, for the purpose of compensating for the time taken to examine and approve
a new drug to be marketed, the patent administrative department under the State Council shall
grant compensation to the validity period of patent rights for the invention patents of new drugs
approved to be marketed in the PRC upon request of the patentee. The compensation period
shall not exceed five years, and the total validity period of patent rights after a new drug is
approved to be marketed shall not exceed fourteen years. During the validity compensation
period of patent rights, the scope of protection of the invention patent of a new drug is limited
to the new drug and its approved indications-related technical solutions; within the scope of
protection, the patentee enjoys the same rights and undertakes the same obligations as those
before the validity compensation period.
On July 4, 2021, the NMPA and the National Intellectual Property Administration jointly
issued the Implementation Measures for Early Resolution Mechanism of Pharmaceutical Patent
Disputes (for Trial Implementation) (ج(༊Б)), which
establishes an early resolution mechanism of pharmaceutical patent disputes; the
pharmaceutical marketing authorization holder shall, within 30 days upon obtainment of
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pharmaceutical registration certificates, register the relevant pharmaceutical patent information
on the PRC Marketing Pharmaceutical Product Patent Information Registration Platform ( ʕ਷
೮া̨̻). When an application is submitted by a chemical generic drug
applicant for its marketing permit, he/she shall make declaration of each relevant
pharmaceutical patent of the generic drugs in accordance with the disclosed patent information
on the PRC Marketing Pharmaceutical Product Patent Information Registration Platform.
Provided there are disputes from the patentee or interested party considering the patent
declaration, he/she may, within 45 days from the disclosure date of the drug marketing
authorization application by drug evaluation institutions in the PRC, initiate legal proceedings
in the People’s Court or apply for an administrative ruling to the patent administration
department of the State Council on whether the relevant technical solution of the drug under
application falls within the scope of protection of the relevant patent right.
Trademark
Pursuant to the Trademark Law of the PRC () promulgated by
the NPCSC on August 23, 1982, and amended on February 22, 1993, October 27, 2001 and
August 30, 2013 respectively, and last amended on April 23, 2019 with the latest amendment
effective on November 1, 2019 and the Implementation Regulations of the Trademark Law of
the PRC (ૢԷ) promulgated by the State Council on August
3, 2002 which became effective on September 15, 2002 and was revised on April 29, 2014 and
the latest amendment became effective on May 1, 2014, the period of validity for a registered
trademark is 10 years, commencing from the date of registration. Upon expiry of the period of
validity, the registrant shall go through the formalities for renewal within 12 months prior to
the date of expiry as required if the registrant needs to continue to use the trademark. Where
the registrant fails to do so, a grace period of six months may be granted. The period of validity
for each renewal of registration is 10 years, commencing from the day immediately after the
expiry of the preceding period of validity for the trademark. In the absence of a renewal upon
expiry, the registered trademark shall be canceled.
Copyright
Copyright is protected by the Copyright Law of the PRC ()
promulgated by the NPCSC on September 7, 1990 and last amended on November 11, 2020
with the latest amendment effective on June 1, 2021 and the Implementation Regulations of the
Copyright Law of PRC (ૢԷ) issued by the State Council
on August 2, 2002 and last amended on January 30, 2013 with the latest amendment effective
on March 1, 2013, which provided provisions on the classification of works and the obtaining
and protection of copyright and the related rights.
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Domain Names
Domain names are protected by the Administrative Measures of Internet Domain Names
() issued by the Ministry of Industry and Information Technology
(the “ MIIT ”) on August 24, 2017 and effective from November 1, 2017 and the Implementing
Rules on Registration of China Country Code Top-level Domain Names (௟ॴਹΤൗ̅
) issued by China Internet Network Information Center on June 18, 2019. The MIIT
is the regulatory body responsible for the administration of PRC internet domain names. The
China Internet Network Information Center is responsible for the administration of registration
of China country code top-level domain names. Domain name registrations are processed by
the domain name registration service agencies established pursuant to the relevant provisions.
The applicants become domain name holders upon successful registration.
Trade Secrets
According to the Anti-Unfair Competition Law of the PRC ( ʕശɛ͏΍ձ਷ˀʔ͍຅
) promulgated by the NPCSC on September 2, 1993 and amended on November 4,
2017 and April 23, 2019 respectively and the Provisions of the Supreme People’s Court on
Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Trade
Secret Infringement (஝
) issued by the Supreme People’s Court on September 10, 2020 and effective from
September 12, 2020, the term “trade secrets” refers to technical, operational and other business
information that is unknown to the public, has business value, may create business interests or
profits for its legal owners or holders, and is maintained as a secret with relevant security
measures taken by its right holders. According to the Anti-Unfair Competition Law of the PRC,
business operators are prohibited from infringing others’ trade secrets by (i) acquiring a trade
secret from the right holder by theft, bribery, fraud, coercion, electronic intrusion or any other
illicit means; (ii) disclosing, using or allowing other person to use a trade secret acquired from
the right holder by any means as specified in the preceding subparagraph; (iii) disclosing, using
or allowing other person to use a trade secret in its possession in violation of its confidentiality
obligation or the requirements of the right holder for keeping the trade secret confidential; (iv)
abetting, tempting or aiding a person into or in acquiring, disclosing, using or allowing other
person to use the trade secret of the right holder in violation of its confidentiality obligation
or the requirements of the right holder for keeping the trade secret confidential. If a third party
knows or should have known the above mentioned illegal conducts but nevertheless acquires,
uses or allows other persons to use such trade secrets, the third party shall be deemed to have
infringed others’ trade secrets. The right holders whose trade secrets are infringed may apply
for administrative corrections, and the regulatory authorities shall order to stop any illegal
activities and impose fine penalties on the infringers.
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Regulations relating to Enterprise Income Tax and V alue-added Tax
Enterprise Income Tax
Pursuant to the Enterprise Income Tax Law of the PRC (੻೼
) (the “ EIT Law ”) promulgated by the NPCSC on March 16, 2007, which became
effective from January 1, 2008, and last amended on December 29, 2018, enterprises shall be
classified into resident enterprises and non-resident enterprises. The income tax rate of resident
enterprises is 25%, while the income tax rate of non-resident enterprises is 20%. According to
the EIT Law and the Implementation Regulations for the Enterprise Income Tax Law of the
PRC (ૢԷ) (the “ Implementation Regulations for
EIT Law ”) issued by the State Council on December 6, 2007, which became effective from
January 1, 2008, and last amended on April 23, 2019, enterprise income tax shall be payable
by a resident enterprise for the income derived from or accruing in or outside the PRC.
Enterprise income tax shall be payable by a non-resident enterprise with office or premises
within the territory of the PRC for the income derived from or accruing in the PRC by its office
or premises, and the income derived from or accruing outside the PRC for which its office or
premises has a de facto relationship. Where the non-resident enterprise has no office or
premises within the territory of the PRC or the income derived or accrued has no de facto
relationship with its office or premises, enterprise income tax shall be payable by the
non-resident enterprise for the income derived from or accruing in the PRC at a reduced rate
of 10%.
V alue-Added Tax
According to the Interim Regulations of the PRC on V alue-added Tax ( ʕശɛ͏΍ձ
೼ᅲБૢԷ), which was promulgated by the State Council on December 13, 1993 and
amended on November 10, 2008, February 6, 2016 and November 19, 2017 respectively, and
the Detailed Rules for the Implementation of the Interim Regulations of the PRC on
V alue-added Tax (), which was promulgated by
the Ministry of Finance on December 25, 1993 and last amended on October 28, 2011 with the
last amendment effective on November 1, 2011, entities and individuals selling goods or
processing, repair and fitting-out services, selling services, intangible assets, immovable
property and importing goods within the territory of the PRC shall be subject to V A T. The
applicable V A T rates, depending on the nature of the taxable acts of the general taxpayer, are
17%, 11%, 6% and 0%, respectively. According to the Circular of the MOF and the SA T on
Adjusting V alue-added Tax Rate (), which
was jointly issued by the MOF and the SA T on April 4, 2018 and took effective on May 1, 2018,
the V A T rates of 17% and 11% originally applicable to general taxpayers’ relevant taxable acts
are adjusted to 16% and 10%, respectively. According to the Circular of the MOF, the SA T and
the General Administration of Customs on Policies in Relation to the Deepening of
V alue-added Tax Reforms (ٙ
ʮѓ), which was jointly issued by the MOF and other departments on March 20, 2019 and
became effective on April 1 2019, the V A T rates of 16% and 10% originally applicable to
general taxpayers’ relevant taxable acts are further adjusted to 13% and 9%, respectively.
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Laws and Regulations Relating to Product Quality
The Product Quality Law of the PRC () promulgated on
February 22, 1993 by the NPCSC and amended on July 8, 2000, August 27, 2009 and December
29, 2018 respectively, is the main law regulating the supervision and management of quality
of products in China. According to the Product Quality Law of the PRC, producers shall be
responsible for the quality of the products they produce, and sellers shall take measures to
maintain the quality of the products they sell. If a defect in a product causes physical injury
or damage to property other than the defective product, the producer shall bear the liability for
compensation, unless the producer can prove any of the following circumstances: (i) the
product has not been put into circulation; (ii) the defect causing the damage did not exist when
the product was put into circulation; (iii) when the product was put into circulation, the level
of science and technology at the time was not sufficient to detect the existence of the defect.
Pursuant to the Civil Code of the PRC (Պ) promulgated by the
NPC on May 28, 2020 and coming into effective on January 1, 2021, where a patient suffers
damage due to defects in drugs, he/she may seek compensation from the drug marketing
authorization holder, producer or also from the medical institution. Where the patient seeks
compensation from the medical institution, the medical institution, after it has made the
compensation, shall have the right to recover the compensation from the liable drug marketing
authorization holder or the producer.
Laws and Regulations Relating to Safety Production
Pursuant to the Safety Production Law of the PRC ()
promulgated by the NPCSC on June 29, 2002 and amended on August 31, 2014 and June 10,
2021 respectively with the latest amendment taking effect on September 1, 2021, production
and operation units shall abide by the Safety Production Law of the PRC and other laws and
regulations related to production safety, strengthen production safety management, and
establish a sound production safety responsibility system and formulate a set of production
safety rules and regulations for all employees; increase the efforts to guarantee the input of
funds, supplies, technology and personnel to production safety, improve production safety
conditions, and strengthen standardization and informatization of production safety; construct
a “dual-prevention” mechanism consisting of graded management and control of safety risks
and examination and control of potential risks, improve the risk prevention and resolution
mechanism, enhance production safety levels and ensure production safety.
Precursor Chemicals
Pursuant to the Regulation on the Administration of Precursor Chemicals (ʷኪ
၍ଣૢԷ) promulgated by the State Council on August 26, 2005, which became effective
on November 1, 2005 and was amended on July 29, 2014, February 6, 2016 and September 18,
2018 respectively, the State regulates the production, operation, purchase, transport, import and
export of precursor chemicals. Unit intending to purchase Category II and III precursor
chemicals shall file with the public security authorities of the local people’s government at the
county level for the types and quantities of precursor chemicals required before making the
purchase.
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Explosive Precursor Hazardous Chemicals
Pursuant to Measures for Public Security Administration of Explosive Precursor
Hazardous Chemicals () promulgated by the Ministry of
Public Security on July 6, 2019 and effective from August 10, 2019, enterprises that have
obtained the safe production permit for hazardous chemicals, the safe use permit for hazardous
chemicals and the business permit for hazardous chemicals in accordance with the laws can
purchase explosive dangerous chemicals with the corresponding permits; and other units
purchasing explosive precursor hazardous chemicals shall provide the following materials to
the selling unit: (i) photocopies of legal certificates of the unit such as industrial and
commercial license ( ʈਠᐄุੂ๫), and legal person certificate for a public institution
(), as well as a photocopy of the identity certificate of the responsible
person; (ii) the instructions of legal use of the explosive precursor hazardous chemicals, in
which should contain the contents about their specific purpose, variety and quantity. Unit
intending to purchase explosive precursor hazardous chemicals shall file with the public
security authorities at the county level where it operates within five days after the purchase,
through the explosive hazardous chemicals information system, about the information of the
variety, quantity and flow of the explosive precursor hazardous chemicals it purchased.
Labor, Social Insurance and Housing Fund
The Labor Law of the PRC () promulgated by the NPCSC on
July 5, 1994 and last amended on December 29, 2018 and the Labor Contract Law of the PRC
() promulgated on June 29, 2007, effective from January 1,
2008, and last amended on December 28, 2012 and effective on July 1, 2013 stipulate the
relationship between the employers and the employees, and specifies the terms and conditions
of the labor contracts.
Pursuant to the Social Insurance Law of the PRC ()
promulgated by the NPCSC on October 28, 2010, effective from July 1, 2011, and last amended
on December 29, 2018, the Provisional Regulations for the Collection and Payment of Social
Insurance Premiums (ᎈ൬ᅄᖮᅲБૢԷ) issued by the State Council on January
22, 1999 and last amended on March 24, 2019, and the Regulations on the Administration of
Housing Provident Fund (၍ଣૢԷ) issued by the State Council on April 3,
1994, and amended on March 24, 2002 and March 24, 2019, respectively, employers are
required to pay social insurance premiums such as basic pension insurance, unemployment
insurance, basic medical insurance, work-related injury insurance and maternity insurance for
their employees, and contribute to housing provident funds.
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Regulations Relating to Information Security and Data Privacy
Data Security and Data Outbound Transfer
On June 10, 2021, the NPCSC promulgated the Data Security Law of the People’s
Republic of China (), with effect on September 1, 2021, which
establishes a classified and tiered system for data protection. Entities engaged in data
processing activities shall, in accordance with laws and regulations, establish a sound data
security management system that covers the whole process of data processing, organize data
security education and training, and take corresponding technological measures and other
necessary measures to protect data security.
On July 7, 2022, the Cyberspace Administration of China promulgated the Measures for
the Security Assessment of Cross-border Data Transmission (),
which came into effect on September 1, 2022, according to which under any of the following
circumstances, a data processor who shall process cross-border data transmission shall report
to the national cyberspace department through the local cyberspace department at the
provincial level for security assessment of cross-border data transmission: (i) transferring
important data outside the PRC by a data processor; (ii) transferring personal information
outside the PRC by a Critical Information Infrastructure Operator or a data processor that has
processed personal information of more than one million individuals; (iii) transferring personal
information outside the PRC by a data processor that has transferred personal information of
more than 100,000 individuals or sensitive personal information of more than 10,000
individuals since January 1 of the previous year; and (iv) other circumstances under which
security assessment of data cross-border transfer is required as prescribed by the national
cyberspace department.
On February 22, 2023, the Cyberspace Administration of China promulgated the
Measures for Standard Contract for Outbound Transfer of Personal Information (̈
), with effect from June 1, 2023. Accordingly, the personal information
processor who provides personal information to any overseas recipient through standard
contract shall meet the following criteria: (i) it is not a critical information infrastructure
operator; (ii) it handles personal information of less than one million individuals; (iii) it
provided personal information of less than 100,000 individuals in aggregate to overseas
recipients since January 1 of the previous year; and (iv) it provided sensitive personal
information of less than 10,000 individuals in aggregate to any overseas recipients since
January 1 of the previous year. In addition, the Measures for Standard Contract for Outbound
Transfer of Personal Information require that all outbound transfers of personal information
that have been carried out before June 1, 2023 and do not comply with the provisions of the
Measures for Standard Contract for Outbound Transfer of Personal Information be rectified
within six months.
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Protection of personal information
Pursuant to the Civil Code, the personal information of a natural person shall be protected
by the law. Any organization or individual that needs to obtain personal information of others
shall obtain such information legally and ensure the security of such information, and shall not
illegally collect, use, process or transmit personal information of others, or illegally purchase,
sell, provide or make public the personal information of others. On August 20, 2021, the
Standing Committee of the National People’s Congress promulgated the Personal Information
Protection Law of the People’s Republic of China (),
which took effect on November 1, 2021. The Personal Information Protection Law further
emphasizes the obligation and responsibility of personal information processors on personal
information and implements stricter protection measures on processing sensitive personal
information.
On November 7, 2016, the Standing Committee of the National People’s Congress issued
the Cyber Security Law of the People’s Republic of China, which came into effect on June 1,
2017. Network operators who collect and utilize personal information shall compile with the
principles of legality, rationality and necessity to disclose the rules of collecting and utilizing
personal information, indicate the purpose, method and scope of collecting and utilizing such
personal information explicitly, and shall obtain consent from the person whose personal
information are being collected. Network operators shall not collect personal information not
related to the services they provide. Network operators may not leak, tamper with, or damage
the personal information that they have collected, and shall not provide such personal
information to other parties without the consent from the person whose personal information
are being collected. However, this does not apply to cases where a specific individual cannot
be identified and the identity cannot be recovered after processing. Network operators shall
adopt technological and other necessary measures to ensure the security of the personal
information collected in order to prevent the leakage, damage and loss of such personal
information.
Regulations Relating to Overseas Listing
According to the Trial Administrative Measures of Overseas Securities Offering and
Listing by Domestic Companies (“ Trial Administrative Measures ”) released by the China
Securities Regulatory Commission (“ CSRC ”) on February 17, 2023 and come into effect on
March 31, 2023, domestic enterprise in the PRC that directly issues securities outside the PRC
shall file with the CSRC in accordance with the Trial Administrative Measures. For the
overseas initial public offering or listing, issuers shall file with the CSRC within three working
days after the submission of its application for listing in overseas region. If the filing materials
are complete and comply with regulations, the CSRC will complete the filing within 20
working days from the date of receipt of the filing materials and will announce the filing
information through its website publicly.
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According to the Trial Administrative Measures, an overseas offering and listing are
prohibited under any of the following circumstances: (i) financing through listing is explicitly
prohibited by laws, administrative regulations or relevant national regulations; (ii) the overseas
offering and listing may endanger national security as determined by the relevant competent
department under the State Council after examination according to the law; (iii) a domestic
enterprise or its controlling shareholder or actual controller has committed a criminal crime of
corruption, bribery, embezzlement, misappropriation of property or disrupting the order of the
socialist market economy in the last three years; (iv) a domestic enterprise is under formal
investigation according to the law for being suspected of any crime or major violation of laws
and regulations, but no clear conclusions have been made; or (v) there is a major dispute over
ownership of the equity held by the controlling shareholder or a shareholder controlled by the
controlling shareholder or the actual controller.
Confidentiality and Archives Administration Concerning Overseas Listing
Pursuant to the Provisions on Strengthening Confidentiality and Archives Administration
Concerning Overseas Securities Offerings and Listings by Domestic Enterprises (̋੶ྤ
), which was jointly announced
by numerous departments including CSRC on February 24, 2023 and came into effect since
March 31, 2023, during the overseas issuance and listing activities of domestic enterprises, such
enterprises and securities companies, securities service institutions which provide corresponding
services shall strictly comply with the relevant laws and regulations of PRC and the requirements
of these Provisions, in order to strengthen the legal awareness on safeguarding national secret and
strengthening archives administration, establish a sound system on confidentiality and archives
administration, and adopt necessary measures for fulfilling its obligations on confidentiality and
archives administration, They shall not leak any national secrets and work secrets of national
authorities, and shall not jeopardize the national and public interests. A domestic enterprise,
which provides or publicly discloses documents and information about the national secrets and
the work secrets of national authorities to entities or individuals such as securities companies,
securities service institutions and overseas regulatory authorities, or provides such documents
and information through its overseas listed entity, shall report to, and obtain approval from
competent authority with approval authorizations in accordance with law, and shall report to the
administrative department of confidentiality at the same level for filing. A domestic company that
provides or publicly discloses documents and information that may pose adverse effects to
national security or public interests to relevant entities or individuals including securities
companies, securities service institutions, and overseas regulators, or provides or publicly
discloses such documents and information through its overseas listed entity, shall strictly fulfill
relevant procedures stipulated by applicable national regulations.
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Regulations Relating to “Full Circulation” of H Shares
According to the Trial Administrative Measures, if a domestic enterprise is directly listed
overseas, when its shareholders of its domestic unlisted shares apply to convert their domestic
unlisted shares held to overseas listed shares and to be circulated in overseas exchanges, it shall
comply with the relevant regulations of CSRC and entrust the domestic enterprises to file with
the CSRC.
According to the Guidelines for the “Full Circulation” Program for Domestic Unlisted
Shares of H-share Listed Companies ( H΅͡ሗ“ஷ”ˏ)
announced by the CSRC on November 14, 2019 and amended on August 10, 2023, shareholders
of domestic unlisted shares may, under the premise of complying with the relevant laws and
regulations and the requirements of the policies on management of state-owned assets, foreign
investment, and industry regulation, among others, determine the amount and proportion of
shares whose circulation is applied for on their own through consultation, and entrust H-share
companies with undergoing the filing formalities with the CSRC. Domestic companies with
limited liability which have not been listed in any exchanges, may file with the “full
circulation” of its H-shares with the CSRC along with its overseas initial public offering.
Shareholders of domestic unlisted shares shall, according to the relevant business rules of
China Securities Depository and Clearing Corporation Limited (the “ CSDC ”), handle
registration of transfer of shares, undergo the formalities of registration of shares, and
quotation and listing of shares, among others, according to the relevant provisions of the Hong
Kong market, and conduct information disclosure according to the laws and regulations.
H-share companies shall submit relevant status report to the CSRC within 15 days after the
shares involved in the application are transferred to the CSDC.
On December 31, 2019, the CSDC and Shenzhen Stock Exchange jointly announced the
Measures for Implementation of H-share “Full Circulation” Business ( Hٰ“ஷ”ุਕྼ
), which are applicable to businesses of cross-border share transfer registration,
maintenance of deposit and holding details, transaction entrustment and instruction
transmission, settlement, management of settlement participants, nominal holder services and
other related operations in relation to the H-share “full circulation business.”
On September 20, 2024, the Shenzhen Branch of CSDC issued the Guidelines to the
Program for “Full Circulation” of H-shares of Shenzhen Branch of China Securities Depository
and Clearing Corporation Limited (ப΂ʮ̡ଉέʱʮ̡Hٰ“ݴ
ஷ”), which are applicable to the business preparation, cross-border share transfer
registration and overseas centralized custody, the initial maintenance of details of domestic
shareholding and the maintenance of its changes, corporate actions, clearing, settlement and
risk management measures. On the same day, China Securities Depository and Clearing (Hong
Kong) Company Limited issued the H-Share Full Circulation Business Guide of China
Securities Depository and Clearing (Hong Kong) Limited ( ʕ਷ᗇՎ೮াഐၑ(ಥ)ʮ
̡Hٰ“ஷ”), which is applicable to businesses such as share custody and
depository, agent service, arrangement for settlement and delivery, and risk management
measures.
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OVERVIEW OF EU LA WS AND REGULATIONS
This section summarizes the principal laws and regulations in the EU that are relevant to
our business.
Clinical Trial Approval
The European Medicines Agency (“ EMA”) is the scientific agency of the EU that
coordinates the evaluation and monitoring of new and approved medicinal products such as
drugs and biologics. It is responsible for the scientific evaluation of applications for EU
marketing authorizations, as well as the development of technical guidance and the provision
of scientific advice to sponsors.
The process regarding approval of medicinal products in the EU follows roughly the same
lines as in the United States and likewise generally involves satisfactorily completing each of
the following:
 preclinical laboratory tests, animal studies and formulation studies all performed in
accordance with the applicable EU Good Laboratory Practice regulations;
 submission to the relevant regulatory agencies in EU member states, or national
authorities, of a clinical trial application (“ CTA”) for each clinical trial, which must
be approved before human clinical trials may begin;
 performance of adequate and well-controlled clinical trials to establish the safety
and efficacy of the product for each proposed indication;
 satisfactory completion of an inspection by the relevant national authorities of the
manufacturing facility or facilities, including those of third parties, at which the
product is produced to assess compliance with cGMP;
 potential audits of the non-clinical and clinical trial sites that generated the data in
support of the Marketing Authorization Application (“ MAA”); and
 in the event that the sponsor elects the mutual recognition procedure or the national
procedure for submitting an MAA, review and approval by the relevant national
authority of the MAA before any commercial marketing, sale or shipment of the
product.
Preclinical studies include laboratory evaluations of product chemistry, formulation and
stability, as well as studies to evaluate the potential efficacy and toxicity in animals. The
conduct of the preclinical tests and formulation of the compounds for testing must comply with
the relevant EU regulations and requirements. The results of the preclinical tests, together with
relevant manufacturing information and analytical data, are submitted as part of the CTA when
seeking approval to start a clinical trial, and with the MAA when seeking marketing
authorization.
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Requirements for the conduct of clinical trials in the EU including Good Clinical Practice
(“GCP”), are implemented in the currently Clinical Trials Directive 2001/20/EC and the GCP
Directive 2005/28/EC. Pursuant to Directive 2001/20/EC and Directive 2005/28/EC, as
amended, a system for the approval of clinical trials in the EU has been implemented through
national legislation of the EU member states. Under this system, approval must be obtained
from the competent national authority in which a trial is planned to be conducted, or in multiple
member states if the clinical trial is to be conducted in a number of member states. The EMA,
however, as the centralized agency, is not involved in the clinical trials approval process. To
this end, a CTA is submitted, which must be supported by an investigational medicinal product
dossier (“ IMPD ”) and further supporting information prescribed by Directive 2001/20/EC and
Directive 2005/28/EC and other applicable guidance documents. Furthermore, a clinical trial
may only be started after a competent ethics committee has issued a favorable opinion on the
clinical trial application in that country.
On January 31, 2022, the Clinical Trials Regulation (EU) No. 536/2014 repealed the
Clinical Trials Directive 2001/20/EC. To ensure that the rules for clinical trials are identical
throughout the EU, the Clinical Trials Regulation (EU) No. 536/2014 was passed as a
regulation which is directly applicable in all EU member states. The Clinical Trials Directive
2001/20/EC will, however, still apply three years from the date of entry into application of the
Clinical Trials Regulation to (i) clinical trials applications submitted before the entry into
application and (ii) clinical trials applications submitted within one year after the entry into
application if the sponsor opts for the old system.
Regulation (EU) No 536/2014 aims to simplify and streamline the approval of clinical
trial in the EU. The main characteristics of the regulation include:
 a streamlined application procedure via a single-entry point, known as the Clinical
Trials Information System (“ CTIS ”);
 a single set of documents to be prepared and submitted for the application as well
as simplified reporting procedures which will spare sponsors from submitting
broadly identical information separately to various and different national
authorities;
 harmonized procedure for the assessment of applications for clinical trials, which is
divided in two parts;
 strictly defined deadlines for the assessment of clinical trial application; and
 the involvement of the ethics committees in the assessment procedure in accordance
with the national law of the member state concerned but within the overall timelines
defined by the Regulation (EU) No 536/2014.
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According to EMA, it does not evaluate applications for the authorization of clinical
trials. Instead, such authorization occurs at EU member state level. The Clinical Trials
Regulation enables sponsors to submit one online application via the CTIS maintained by the
EMA, through which regulators and authorities of each state can collaboratively process
clinical trial applications, request further information, authorize or refuse a trial and oversee
an authorized trial. The evaluation process of an initial clinical trial application includes three
main phases: validation, assessment and decision. The assessment phase includes two parts:
Part I and Part II.
 Part I is a joint assessment by the member states concerned (“ MSCs ”) led by the
reporting member state (“ RMS”) on aspects primarily related to scientific
documentation, manufacturing and importing requirements, labeling requirements
and completeness and adequateness of the investigator’s brochure.
 Part II is a separate assessment performed by each MSC, each of which results in the
submission of an individual conclusion. The scope of the Part II assessment is set
out in the Clinical Trial Regulation and primarily relate to aspects such as informed
consent, compensation, protection of data and samples, patient recruitment and
suitability of clinical trial sites.
Request for information (“ RFIs ”) may be raised by RMS for Part I or by the MSC for Part
II. Each MSC decides if the application is complete and adequate, and therefore if the clinical
trial can be conducted in its territory.
A clinical trial sponsor may apply to its preferred MSC to conduct a clinical trial,
including a Phase III or other pivotal studies following the completion of earlier trial phases,
provided that the applicable procedures and requirements of that MSC are satisfied.
Clinical Trial Implementation
Article 47 of the Clinical Trials Regulation (EU) No. 536/2014 provides that the sponsor
of a clinical trial and the investigator shall ensure that the clinical trial is conducted in
accordance with the protocol and with the principles of good clinical practice. Also, the
sponsor and the investigator, when drawing up the protocol and when applying this Regulation
and the protocol, shall also take appropriate account of the quality standards and the guidelines
established by the International Council for Harmonisation of Technical Requirements of
Pharmaceuticals for Human Use (“ ICH”) on good clinical practice.
ICH E6(R3) Guideline for Good Clinical Practice provides that the sponsor may consider
establishing a data review team or data monitoring committee to assess the progress of a
clinical trial, including the safety data and the efficacy endpoints, at intervals and to
recommend to the sponsor whether to continue, modify or stop a trial.
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Marketing Authorization
Centralized procedure
Authorization to market a product in the member states of the EU proceeds under one of
four procedures: a centralized procedure, a mutual recognition procedure, a decentralized
procedure or a national procedure.
The centralized procedure enables applicants to obtain a marketing authorization that is
valid in all EU member states based on a single application. Certain medicinal products,
including products developed by means of biotechnological processes must undergo the
centralized authorization procedure for marketing authorization, which, if granted by the
European Commission, based on the opinion of the EMA, is automatically valid in all EU
member states. Sponsors may elect to file an MAA through the centralized procedures for other
classes of products.
The centralized procedure is mandatory for certain types of products such as, medicines
derived from biotechnology processes such as genetic engineering, advanced-therapy
medicines such as gene-therapy or tissue engineered medicine, orphan medicines, and
medicinal products containing a new active substance indicated for the treatment of cancer,
diabetes, neurodegenerative disorders, autoimmune and other immune dysfunctions, and viral
diseases. The centralized procedure is mandatory for GFH925, because it is a new active
substance for which the therapeutic indication is the treatment of cancer.
The centralized authorization procedure is optional for other medicinal products if they
contain a new active substance, if the applicant shows that the medicinal product concerned
constitutes a significant therapeutic, scientific or technical innovation, or that the granting of
authorization is in the public interest of the EU.
The mutual recognition procedure refers to a procedure through which an authorization
of a medicine in one EU Member State is recognized by another Member State. The
decentralized procedure refers to the procedure for authorizing medicines in more than one EU
Member State in parallel. It can be used for medicines that do not need to be authorized via
the centralized procedure and have not already been authorized in any Member State. The
national procedure refers to the procedure in which the competent authorities of respective EU
Member States are responsible for reviewing the marketing authorisation applications made by
pharmaceutical companies.
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Administration Procedure
MAAs should first be electronically submitted to the EMA through the eSubmission
gateway. The MAA shall include data in line with the EU legislation. This includes details of
the target patient population, as well as an explanation of whether the medicine addresses an
unmet medical need. The application must present information on the medicine’s quality,
including its chemical, physical, and biological properties such as stability, purity, and
biological activity, and demonstrate compliance with international standards for laboratory
testing, manufacturing, and clinical trials, namely good laboratory practice, good
manufacturing practice, and good clinical practice.
The MAA should describe the medicine’s mechanism of action based on laboratory
studies, how it is distributed and eliminated in the body, and the clinical benefits observed in
the intended patient group. It must also set out the safety profile, including side effects
identified in patients, with specific attention to special populations such as children or the
elderly. The application should detail how potential risks will be managed and monitored after
authorization, and what follow-up studies are planned; these elements are contained in a risk
management plan (RMP), which is reviewed by the European Medicines Agency’s safety
committee, PRAC, for suitability.
Additionally, the applicant must provide the information intended for patients and
healthcare professionals, including the Summary of Product Characteristics (SmPC), labelling,
and package leaflet. These documents are reviewed and approved by the CHMP to ensure they
are accurate and appropriate. EMA then performs a technical validation of the MAAs it
receives. The objective is to make sure that all essential regulatory elements required for
scientific assessment are included in the application prior to the start of the procedure. If EMA
needs additional information to complete its validation of the application, it will ask the
applicant to supply the additional by a deadline. After the MAA is validated by the EMA, it will
be referred to EMA ’s Committee for Human Medicinal Products (“ CHMP ”).
Under the centralized procedure, the CHMP serves as the scientific committee that
renders opinions about the safety, efficacy and quality of medicinal products for human use on
behalf of the EMA. The standards and requirements of the evaluation by the CHMP are the
same across member statements throughout the E.U. The CHMP is composed of experts
nominated by each member state’s national authority for medicinal products, with one of them
appointed to act as Rapporteur for the co-ordination of the evaluation with the possible
assistance of a further member of the Committee acting as a Co-Rapporteur. After approval, the
Rapporteur(s) continue to monitor the product throughout its life cycle. The CHMP has 210
active days, to adopt an opinion as to whether a marketing authorization should be granted. The
process usually takes longer in case additional information is requested, which triggers
clock-stops in the procedural timelines. The process is complex and involves extensive
consultation with the regulatory authorities of member states and a number of experts. When
an application is submitted for a marketing authorization in respect of a drug which is of major
interest from the point of view of public health and in particular from the viewpoint of
therapeutic innovation, the applicant may, pursuant to Article 14(9) Regulation (EC) No
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726/2004, request an accelerated assessment procedure. If the CHMP accepts such request, the
time-limit of 210 days will be reduced to 150 days, but it is possible that the CHMP can revert
to the standard time-limit for the centralized procedure if it considers that it is no longer
appropriate to conduct an accelerated assessment. The final CHMP recommendation is reached
by a formal vote. Ideally, the CHMP will come to a consensus and unanimously recommend
either the approval or refusal of the marketing authorisation; such a consensus is reached in
most of the cases. However, when a final recommendation by consensus cannot be reached,
CHMP’s final recommendation will represent the majority view. The divergent opinions and
the names of the members expressing them are attached to the opinion of the committee and
mentioned in the meeting minutes. The divergent opinions are then published together with the
public assessment report. Once the procedure is completed, a European Public Assessment
Report (“ EPAR”) is produced. If the opinion is negative, information is given as to the grounds
on which this conclusion was reached. After the adoption of the CHMP opinion, a decision on
the MAA must be adopted by the European Commission, after consulting the EU member
states, which in total can take more than 60 days. During such consultation period, each
member state has 22 days to forward their written observations on the draft decision to the
European Commission. Concerned member states may request in writing that the draft decision
referred be discussed by a plenary meeting of the Standing Committee on Medicinal Products
for Human Us, stating their reasons in detail. Where, in the opinion of the European
Commission, a member state’s written observations raise important new questions of a
scientific or technical nature which the opinion delivered by the EMA has not addressed, the
Chairman of the European Commission shall suspend the procedure and refer the application
back to the EMA for further consideration. In other words, under the centralized procedure, if
a member state has significant concerns, different opinions or negative findings about a
medicine during the evaluation phase, it can be raised within the CHMP and the European
Commission. However, the final decision rests with the European Commission, and if the
European Commission renders a favorable decision, such significant concerns, different
opinions or negative findings from a member state cannot override such favorable decision. An
applicant for a marketing authorisation is not required to obtain prior consent or clearance from
the member states in which the clinical trial was conducted. A centralized marketing
authorisation shall be valid throughout the European Commission and EEA-EFTA states
(Iceland, Liechtenstein and Norway). It shall confer the same rights and obligations in each of
the member states as a marketing authorisation granted by that member state. The European
Commission carefully evaluates the application to verify compliance with stringent EU
standards for safety, efficacy, and quality, culminating in the decision to grant or deny
marketing authorization. After a drug has been authorized and launched, it is a condition of
maintaining the marketing authorization that all aspects relating to its quality, safety and
efficacy must be kept under review.
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Import of Investigational Medicinal Products
In the European Union, the manufacture and import of investigational medicinal products
(“IMPs ”) for clinical trial use are subject to prior authorization, subject to certain exemptions.
Such authorisation requires the applicant to maintain suitable premises, equipment and quality
control facilities that meet prescribed standards, and to have at least one permanently available
qualified person meeting the professional requirements under applicable EU legislation. Each
batch manufactured or imported into the EU must be certified by the qualified person as
meeting the applicable quality and compliance requirements. IMPs must be manufactured in
accordance with EU GMP , and imported IMPs must meet quality standards at least equivalent
to EU GMP . The European Commission issues detailed GMP guidelines and Member States
monitor compliance through inspections.
Exemptions from the authorisation requirement referred to in the above paragraph apply
to the preparation of medicinal products for use as investigational medicinal products, where
this process is carried out in hospitals, health centres or clinics legally authorised in the
member state concerned to carry out such process and if the investigational medicinal products
are intended to be used exclusively in hospitals, health centers or clinics taking part in the same
clinical trial in the same member state.
Conditional Approval
In specific circumstances, EU legislation (Article 14(7) Regulation (EC) No. 726/2004
and Regulation (EC) No. 507/2006 on Conditional Marketing Authorizations for Medicinal
Products for Human Use) enables applicants to obtain a conditional marketing authorization
prior to obtaining the comprehensive clinical data required for an application for a full
marketing authorization. Such conditional approvals may be granted for products (including
medicines designated as orphan medicinal products), if (1) the risk-benefit balance of the
product is positive, (2) it is likely that the applicant will be in a position to provide the required
comprehensive clinical trial data, (3) the product fulfills unmet medical needs, and (4) the
benefit to public health of the immediate availability on the market of the medicinal product
concerned outweighs the risk inherent in the fact that additional data are still required. A
conditional marketing authorization may contain specific obligations to be fulfilled by the
marketing authorization holder, including obligations with respect to the completion of
ongoing or new studies, and with respect to the collection of pharmacovigilance data.
Conditional marketing authorizations are valid for one year, and may be renewed
annually, if the risk-benefit balance remains positive, and after an assessment of the need for
additional or modified conditions and/or specific obligations. The timelines for the centralized
procedure described above also apply with respect to the review by the CHMP of applications
for a conditional marketing authorization.
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Post-Authorization Measures
After obtaining a marketing approval in the EU, the applicant may be required by the
EMA, on a case-by-case basis, to provide certain additional data post-authorization, including
data about the safety and, in certain cases, the efficacy or quality of authorized medicinal
products. Such post-authorization measures may be aimed at collecting or providing data to
enable the assessment of the safety or efficacy of medicinal products in the post-approval
setting. An applicant will not be notified about the requirement of post-authorization measures,
if any, with respect to their approved products until and after the receipt of marketing approval
from the EMA. Under centralized procedures, member states do not have unilateral authority
to impose a post-authorization study on the drugs approved by the European Commission.
OVERVIEW OF U.S. LA WS AND REGULATIONS
This section summarizes the principal laws and regulations in the U.S. that are relevant
to our business.
U.S. Government Regulation of Drug and Biological Products
In the U.S., the FDA regulates drugs under the FDCA, its implementing regulations and
biologics under the FDCA and the Public Health Service Act (the “ PHSA ”) and their
implementing regulations. Both drugs and biologics also are subject to other federal, state and
local statutes and regulations, such as those related to competition. The process of obtaining
regulatory approvals and the subsequent compliance with appropriate federal, state, and local
statutes and regulations requires the expenditure of substantial time and financial resources.
Failure to comply with the applicable U.S. requirements at any time during the product
development process, approval process or following approval may subject an applicant to
administrative actions or judicial sanctions. These actions and sanctions could include, among
other actions, the FDA ’s refusal to approve pending applications, withdrawal of an approval,
license revocation, a clinical hold, untitled or warning letters, voluntary or mandatory product
recalls or market withdrawals, product seizures, total or partial suspension of production or
distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement and
civil or criminal fines or penalties. Any agency or judicial enforcement action could have a
material adverse effect on our business, the market acceptance of our products and our
reputation.
Once a product candidate is identified for development, it enters pre-clinical testing,
which includes laboratory evaluations of product chemistry, toxicity, formulation and stability,
as well as animal studies. Pre-clinical testing is conducted in accordance with FDA ’s Good
Laboratory Practice regulations. A sponsor of IND must submit the results of the pre-clinical
testing, manufacturing information, analytical data, the clinical trial protocol, and any
available clinical data or literature to the FDA. The IND automatically becomes effective 30
days after receipt by the FDA, unless the FDA raises concerns or questions and places the trial
on a clinical hold within that 30-day period. FDA may also impose clinical holds or partial
clinical holds at any time during clinical trials due to safety concerns or non-compliance.
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All clinical trials, which involve the administration of the investigational product to
humans, must be conducted under the supervision of one or more qualified investigators in
accordance with Good Clinical Practice regulations, including the requirement that all research
subjects provide informed consent in writing before their participation in any clinical trial.
Further, an Institutional Review Board (“ IRB”), must review and approve the plan for any
clinical trial before it commences at any institution, and the IRB must conduct continuing
review and reapprove the study at least annually. Each new clinical protocol and any
amendments to the protocol must be submitted for FDA review, and to the IRBs for approval.
An IRB can suspend or terminate approval of a clinical trial at its institution if the trial is not
being conducted in accordance with the IRB’s requirements or if the product has been
associated with unexpected serious harm to subjects.
Clinical trials generally are conducted in three sequential phases, known as Phase I, Phase
II and Phase III, and may overlap.
 Phase I clinical trials generally involve a small number of healthy volunteers or
disease-affected patients who are initially exposed to a single dose and then multiple
doses of the product candidate. The primary purpose of these clinical trials is to
assess the metabolism, pharmacologic action, side effect, tolerability and safety of
the product candidate.
 Phase II clinical trials involve studies on disease-affected patients to evaluate proof
of concept and/or determine the dose required to produce the desired benefits. At the
same time, safety and further PK and PD information is collected, possible adverse
effects and safety risks are identified, and a preliminary evaluation of efficacy is
conducted.
 Phase III clinical trials generally involve a large number of patients at multiple sites
and are designed to provide the data necessary to demonstrate the effectiveness of
the product for its intended use, its safety in use and to establish the overall
benefit/risk relationship of the product and provide an adequate basis for product
labeling.
Progress reports detailing the results of the clinical trials must be submitted at least
annually to the FDA. Safety reports must be submitted to the FDA and the investigators’ 15
calendar days after the trial sponsor determines that the information qualifies for reporting. The
sponsor also must notify FDA of any unexpected fatal or life-threatening suspected adverse
reaction as soon as possible but in no case later than 7 calendar days after the sponsor’s initial
receipt of the information. Sponsors of clinical trials of FDA-regulated products, including
drugs, are required to register and disclose certain clinical trial information, which is publicly
available at www.clinicaltrials.gov .
Concurrent with clinical trials, companies usually complete additional animal studies and
must also finalize a process for manufacturing the product in commercial quantities in
accordance with GMP requirements. The process of obtaining regulatory approvals and
compliance with appropriate federal, state, local and foreign statutes and regulations require
the expenditure of substantial time and financial resources. Failure to comply with the
applicable U.S. requirements may subject an applicant to administrative or judicial sanctions.
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U.S. Review and Approval Processes
The results of product development, pre-clinical studies and clinical trials, along with
descriptions of the manufacturing process, analytical tests conducted on the product, proposed
labeling and other relevant information, are submitted to the FDA as part of an NDA or BLA.
Unless deferred or waived, NDAs or BLAs, or supplements must contain data adequate to
assess the safety and effectiveness of the product for the claimed indications in all relevant
pediatric subpopulations and to support dosing and administration for each pediatric
subpopulation for which the product is safe and effective. The submission of an NDA or a BLA
is subject to the payment of a substantial user fee and an annual prescription drug product
program fee.
Within 60 days of its receipt, the FDA reviews the NDA/BLA to ensure that it is
sufficiently complete for substantive review before it accepts the NDA/BLA for filing. After
accepting the NDA/BLA filing, the FDA begins an in-depth substantive review to determine,
among other things, whether a product is safe and effective for its intended use. The FDA also
evaluates whether the product’s manufacturing is GMP-compliant to assure the product’s
identity, strength, quality and purity. Before approving the NDA/BLA, the FDA typically will
inspect whether the manufacturing processes and facilities are in compliance with GMP
requirements and adequate to assure consistent production of the product within required
specifications. The FDA may refer the NDA/BLA to an advisory committee, a panel of experts,
for review whether the application should be approved and under what conditions and
considers such recommendations when making decisions.
The FDA may refuse to approve the NDA/BLA if the applicable regulatory criteria are not
satisfied or may require additional clinical data or other data and information. The FDA will
issue a complete response letter describing all of the specific deficiencies that the FDA
identified in the NDA/BLA that must be satisfactorily addressed before it can be approved. The
deficiencies identified may be minor, for example, requiring labeling changes, or major, for
example, requiring additional clinical trials. Additionally, the complete response letter may
include recommended actions that the applicant might take to place the application in a
condition for approval. The applicant may either resubmit the NDA/BLA, addressing all of the
deficiencies identified in the letter, or withdraw the application or request an opportunity for
a hearing.
The regulatory approval may be limited to specific diseases and dosages or the indications
for use may otherwise be limited, which could restrict the commercial value of the product.
Further, the FDA may require that certain contraindications, warnings or precautions be
included in the product labeling. In addition, the FDA may require post-approval studies,
including Phase IV clinical trials, to further assess a product’s safety and effectiveness after
NDA/BLA approval and may require testing and surveillance programs to monitor the safety
of approved products that have been commercialized.
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In the U.S., products composed of components that would normally be regulated by
different centers at the FDA are known as combination products. Typically, the FDA ’s Office
of Combination Products assigns a combination product to a specific Agency Center as the lead
reviewer. The FDA determines which Center will lead a product’s review based upon the
product’s primary mode of action. Depending on the type of combination product, its approval,
clearance or licensure may usually be obtained through the submission of a single marketing
application. However, the FDA sometimes will require separate marketing applications for
individual constituent parts of the combination product, which may require additional time,
effort, and information. Even when a single marketing application is required for a combination
product, the relevant Centers may participate in the review. An applicant will also need to
discuss with the Agency how to apply certain premarket requirements and post-marketing
regulatory requirements, including conduct of clinical trials, adverse event reporting and good
manufacturing practices, to their combination product.
Expedited Development and Review Programs
The FDA has various programs that are intended to expedite or streamline the process for
the development and FDA review of drugs that are intended for the treatment of serious or
life-threatening diseases or conditions and demonstrate the potential to address unmet medical
needs. The purpose of these programs is to provide important new drugs to patients earlier than
under standard FDA review procedures. The programs include fast track designation,
breakthrough therapy designation, accelerated approval, priority review and orphan drug
designation, among others.
Fast Track Designation
To be eligible for a fast-track designation, the FDA must determine, based on the request
of a sponsor, that a drug is intended to treat a serious or life-threatening disease or condition
for which there is no effective treatment and demonstrates the potential to address an unmet
medical need for the disease or condition. Under the fast-track program, the sponsor of a drug
candidate may request FDA to designate the product for a specific indication as a fast-track
product concurrent with or after the filing of the IND for the drug candidate. The FDA must
make a fast-track designation determination within 60 days after receipt of the sponsor’s
request.
In addition to other benefits, such as the ability to use surrogate endpoints and have more
interactions with FDA, FDA may initiate review of sections of a fast-track product’s NDA
before the application is complete. This rolling review is available if the applicant provides,
and FDA approves, a schedule for the submission of the remaining information and the
applicant pays applicable user fees. However, FDA ’s time period goal for reviewing a fast-track
application does not begin until the last section of the NDA is submitted. In addition, the
fast-track designation may be withdrawn by FDA if FDA believes that the designation is no
longer supported by data emerging in the clinical trial process.
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Orphan Drug Designation
Under The Orphan Drug Act of 1983, the FDA may grant orphan drug designation to
drugs or biologic candidates intended to treat a rare disease or condition generally affecting
fewer than 200,000 individuals in the U.S. or for which a manufacturer has no reasonable
expectation of recovering drug treatment research and development costs. The first applicant
to receive FDA approval for the disease or indication for which it has orphan drug designation
is entitled to a seven-year exclusive marketing period. During the exclusivity period, the FDA
may not approve any other applications to market the same product for the same disease or
condition except in limited circumstances.
Accelerated Approval
Under FDA ’s accelerated approval regulations, the FDA may approve a drug or biologic
candidate for a serious or life-threatening illness that provides meaningful therapeutic benefit
to patients over existing treatments and demonstrates an effect on either a surrogate endpoint
that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be
measured earlier than irreversible morbidity or mortality (“ IMM”), that is reasonably likely to
predict an effect on IMM or other clinical benefit, taking into account the severity, rarity, or
prevalence of the disease or condition and the availability or lack of alternative treatments. A
product candidate approved on this basis is subject to rigorous post-marketing compliance
requirements, including the completion of post-approval clinical trial to confirm the effect on
the clinical endpoint. Failure to conduct required post-approval studies, or to confirm a clinical
benefit during post-marketing studies, will allow the FDA to withdraw the product from the
market on an expedited basis. All promotional materials for product candidates approved under
accelerated regulations are subject to prior review by the FDA.
Breakthrough Therapy Designation
Another program available for sponsors is the breakthrough therapy designation. A drug
or biologic may be eligible for designation as a breakthrough therapy if the product is intended,
alone or in combination with one or more other drugs or biologics, to treat a serious or
life-threatening condition and preliminary clinical evidence indicates that the product may
demonstrate substantial improvement over currently approved therapies on one or more
clinically significant endpoints, such as substantial treatment effects observed early in clinical
development. A sponsor may request that a product be designated as a breakthrough therapy
concurrently with, or at any time after, the submission of IND, and the FDA must determine
if the candidate qualifies for such designation within 60 days of receipt of the request. If so
designated, the FDA shall act to expedite the development and review of the product’s
marketing application, including by meeting with the sponsor throughout the product’s
development, providing timely advice to the sponsor to ensure that the development program
to gather pre-clinical and clinical data is as efficient as practicable.
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Priority Review
The FDA may give a priority review designation to drugs that offer major advances in
treatment or provide a treatment where no adequate therapy exists. A priority review means that
the goal for the FDA to review an application is six months, rather than the standard review
of ten months under the Prescription Drug User Fee Act guidelines. These six- and ten-month
review periods are measured from the “filing” date rather than the receipt date for NDAs for
new molecular entities, which typically adds approximately two months to the timeline for
review and decision from the date of submission. Most products that are eligible for fast-track
designation are also likely to be considered appropriate to receive a priority review.
Post-Marketing Requirements
Following the approval of a new product, the manufacturer and the approved product are
subject to continuing regulation by the FDA, including, among other things, monitoring and
record-keeping activities, reporting of adverse experiences, complying with promotion and
advertising requirements, which include restrictions on promoting products for unapproved
uses or patient populations (known as “off-label use”) and limitations on industry-sponsored
scientific and educational activities. Although physicians may prescribe legally available
products for off-label uses, manufacturers may not market or promote such uses. The FDA and
other agencies actively enforce the laws and regulations prohibiting the promotion of off-label
uses, and a company that is found to have improperly promoted off-label uses may be subject
to significant liability, including investigation by federal and state authorities. Prescription
drug promotional materials must be submitted to the FDA in conjunction with their first use or
first publication. Further, if there are any modifications to the drug or biologic, including
changes in indications, labeling or manufacturing processes or facilities, the applicant may be
required to submit and obtain FDA approval of a new NDA/BLA or NDA/BLA supplement,
which may require the development of additional data or preclinical studies and clinical trials.
The FDA may also place other conditions on approvals including the requirement for a
risk evaluation and mitigation strategy (“ REMS ”), to assure the safe use of the product. If the
FDA concludes a REMS is needed, the sponsor of the NDA/BLA must submit a proposed
REMS. The FDA will not approve the NDA/BLA without an approved REMS, if required. A
REMS could include medication guides, physician communication plans or elements to assure
safe use, such as restricted distribution methods, patient registries and other risk minimization
tools. Any of these limitations on approval or marketing could restrict the commercial
promotion, distribution, prescription or dispensing of products. Product approvals may be
withdrawn for non-compliance with regulatory standards or if problems occur following initial
marketing.
FDA regulations require that products be manufactured in specific approved facilities and
in accordance with cGMP regulations. These manufacturers must comply with cGMP
regulations that require, among other things, quality control and quality assurance, the
maintenance of records and documentation, and the obligation to investigate and correct any
deviations from cGMP .
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Manufacturers and other entities involved in the manufacture and distribution of approved
drugs or biologics are required to register their establishments with the FDA and certain state
agencies and are subject to periodic unannounced inspections by the FDA and certain state
agencies for compliance with cGMP requirements and other laws. Accordingly, manufacturers
must continue to expend time, money and effort in the area of production and quality control
to maintain cGMP compliance. The discovery of violative conditions, including failure to
conform to cGMP regulations, could result in enforcement actions, and the discovery of
problems with a product after approval may result in restrictions on a product, manufacturer
or holder of an approved NDA/BLA, including recall.
Once an approval is granted, the FDA may issue enforcement letters or withdraw the
approval of the product if compliance with regulatory requirements and standards is not
maintained or if problems occur after the drug or biologic reaches the market. Corrective action
could delay drug or biologic distribution and require significant time and financial
expenditures. Later discovery of previously unknown problems with a drug or biologic,
including AEs of unanticipated severity or frequency, or with manufacturing processes, or
failure to comply with regulatory requirements, may result in revisions to the approved
labeling to add new safety information; imposition of post-market studies or clinical trials to
assess new safety risks; or imposition of distribution or other restrictions under a REMS
program. Other potential consequences include, among other things:
 restrictions on the marketing or manufacturing of the drug or biologic, suspension
of the approval, complete withdrawal of the drug from the market or product recalls;
 fines, warning letters or holds on post-approval clinical trials;
 refusal of the FDA to approve applications or supplements to approved applications,
or suspension or revocation of drug or biologic approvals; drug or biologic seizure
or detention, or refusal to permit the import or export of drugs; or
 injunctions or the imposition of civil or criminal penalties.
Optimizing the Dosage of Human Prescription Drugs and Biological Products for the
Treatment of Oncologic Diseases
In August 2024, the U.S. Food and Drug Administration (FDA) issued guidance on
optimizing the dosage of oncology drugs and biological products, encouraging sponsors to
determine an optimal dosage that maximizes therapeutic benefit while minimising toxicity
early in clinical development.
This guidance is intended to assist sponsors in identifying an optimized dosage(s) for
human prescription drugs or biological products for the treatment of oncologic diseases during
clinical development and prior to submitting an application for approval of a new indication
and usage.
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This reflects a shift from the traditional focus on identifying the maximum tolerated dose,
which may not be appropriate for modern targeted therapies that can achieve similar efficacy
at lower, more tolerable doses. The guidance notes that unnecessarily high doses may adversely
affect patient quality of life, treatment adherence and clinical outcomes.The guidance
encourages early engagement with the FDA, including through formal meetings or the
Model-Informed Drug Development paired meeting programe, to discuss dosage optimization
plans.
Key Data Collection and Evaluation Areas
Sponsors are encouraged to initiate early evaluations of population pharmacokinetics,
dose- and exposure-response relationships, the impact of intrinsic factors on pharmacokinetics,
pharmacodynamics and safety, and potential drug–drug interactions.
 PK/PD/Pharmacogenomics: Implement sampling plans to characterize drug
behavior and variability; analyze exposure–response early; consider intrinsic factors
(e.g., genetics, organ impairment) and alternative dosing strategies.
 Trial Design: Compare multiple dosages in randomized, parallel, or adaptive trials
to assess efficacy, safety, and tolerability; use model-informed approaches to select
dose levels; ensure trials are sized to detect meaningful safety and activity
differences.
 Safety/Tolerability: Evaluate dose modifications, discontinuations, and patient-
reported outcomes (PROs); predefined stopping rules for toxicity; consider
strategies like dose titration for drugs with early-onset toxicities.
 Drug Formulation: Ensure suitable dose strengths and forms are available to
facilitate evaluation of multiple dosages.
 Subsequent Indications: Dosage may differ by disease setting; further dose-finding
may be required for new indications or combinations.
The use of modeling approaches, including semi-mechanistic or mechanistic methods, is
recommended to inform dosage selection for both current and future indications. Dose
optimization studies are expected to compare multiple dosages using relevant clinical
endpoints such as overall response rate or progression-free survival, and may incorporate data
from similar therapies where appropriate. Features such as blinding to reduce bias, pre-
specified crossover analysis plans, and intra-patient dose adjustments to improve tolerability
are also encouraged.
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Patent Term Restoration and Marketing Exclusivity
After approval, owners of relevant drug or biological product patents may apply for up
to a five-year patent extension to restore a portion of patent term lost during product
development and FDA review of an NDA or a BLA if approval of the application is the first
permitted commercial marketing or use of a biologic containing the active ingredient under the
Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the
Hatch-Waxman Act. The allowable patent term extension is calculated as one-half of the
product’s testing phase, which is the time between IND and NDA/BLA submission, and all of
the review phase, which is the time between NDA/BLA submission and approval, up to a
maximum of five years. The time can be shortened if the FDA determines that the applicant did
not pursue approval with due diligence. The total patent term after the extension may not
exceed more than 14 years from the date of FDA approval of the product. Only one patent
claiming each approved product is eligible for restoration, only those claims covering the
approved product, a method for using it, or a method for manufacturing it may be extended,
and the patent holder must apply for restoration within 60 days of approval. The USPTO, in
consultation with the FDA, reviews and approves the application for patent term restoration.
For patents that might expire during the application phase, the patent owner may request an
interim patent extension. An interim patent extension increases the patent term by one year and
may be renewed up to four times. For each interim patent extension granted, the post-approval
patent extension is reduced by one year. The director of the USPTO must determine that
approval of the drug candidate covered by the patent for which a patent extension is being
sought is likely. Interim patent extensions are not available for a drug candidate for which an
NDA or a BLA has not been submitted.
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OVERVIEW
We are a biopharmaceutical company based in China, featuring a global vision,
international collaborations and operations. Our history can be traced back to 2017 when our
Company was established in August 2017 as a limited liability company under the PRC
Company Law with the name “˙ᖹุ(ɪऎ)ʮ̡.” In April 2018, our Company was
renamed as “Ҧ(ɪऎ)ʮ̡.” On September 29, 2024, our Company was
converted into a joint stock company with limited liability, and was renamed as GenFleet
Therapeutics (Shanghai) Inc. (Ҧ(ɪऎ)ʮ̡).
Our Group was founded by Dr. Lu, our Chairman and executive Director and Dr. Lan, our
executive Director, Chief Executive Officer and General Manager. Dr. Lu and Dr. Lan have
extensive research and managerial experience in the biotechnology and pharmaceutical
industry across the PRC and the United States. For details of the biographical background and
relevant industry experience of Dr. Lu and Dr. Lan, see “Directors, Supervisors and Senior
Management.”
BUSINESS DEVELOPMENT MILESTONES
The following table summarizes the key milestones in our business development:
Y ear Milestone
2017 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Our Company was established in the PRC
2018 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118We commenced our endeavor to discover and develop innovative
RAS-targeting therapies, including our Core Product GFH925
We completed an angel financing round with investors including,
among others, HighLight Capital, in an aggregate amount of
RMB60 million
Our first R&D laboratory commenced operation in Zhangjiang,
Shanghai
2019 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118We completed series A and series A+ financing with investors
including Ningbo Hongjia, Jianyi Capital, CSPC and Haibang
V enture Capital, in an aggregate amount of approximately
RMB140 million
We submitted our first IND application in China within 19
months after our establishment
2020 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118We received the IND approval in China and the United States
with respect to GFH009
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Y ear Milestone
2021 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118We received the IND approval from the NMPA for GFH925 for a
Phase I/II clinical trial in patients with advanced solid tumors
with the KRAS G12C mutation
We commenced our Phase I clinical trial of GFH312 in Australia
We arranged eight clinical sites in multiple provinces in China,
and activated one clinical trial site in 2021 in preparation for the
clinical trial of GFH925 in China
We entered into collaboration agreement with Innovent (Hong
Kong Stock Exchange: 1801) in relation to the clinical
development and commercialization of GFH925
We completed series B and B+ financing with investors
including, among others, CDH Investments, Shenzhen Capital,
Panlin Capital and Northern Light V enture Capital, in an
aggregate amount of approximately RMB543 million
2022 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118We submitted the investigational medicinal product dossier to the
CTIS maintained by the EMA for the KROCUS trial, which is a
Phase Ib/II trial of GFH925 in combination with cetuximab to
assess the combination therapy as a first-line treatment of
advanced NSCLC
We entered into a clinical trial collaboration and supply
agreement with Merck Healthcare KGaA to secure cetuximab for
the KROCUS trial
We completed the Phase I clinical trial of GFH312 in Australia
We received the IND approval for a Phase I clinical trial of
GFH312 in healthy participants in China, and we initiated the
trial
The FDA approved our Phase II clinical trial of GFH312 for
peripheral artery disease with intermittent claudication
We entered into collaboration agreement with SELLAS
(NASDAQ: SLS) in relation to the co-development of GFH009
We completed series C financing with investors including, among
others, Huagai Capital, Cherami Sun Tour, Shanjin Capital and
Huimei Capital, in an aggregate amount of approximately
RMB483 million
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Y ear Milestone
2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Italy, Spain and Greece authorized the KROCUS trial and we
initiated the KROCUS trial in these countries
The Phase Ib trial of KROCUS reached the primary endpoints,
and there were no objection from the data review team or relevant
health authorities to the commencement of the Phase II trial
The GFH925 monotherapy received two Breakthrough Therapy
Designations from the NMPA for treating advanced KRAS
G12C-mutant NSCLC and CRC patients
We completed the Phase I clinical trial of GFH312 in China
We entered into a collaboration and option agreement with
V erastem, pursuant to which, on a program-by-program basis, we
granted V erastem options to acquire an exclusive license to
develop and commercialize three product candidates, including
GFH375, in territories outside of Greater China within the
specified option exercise period
2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118GFH925 (marketed under the name Dupert
®) was approved by
NMPA for the treatment of patients with advanced NSCLC
harboring KRAS G12C mutation who have received at least one
systemic therapy
We reported the results of the KROCUS trial for GFH925 as a
late-breaking oral presentation at the 2024 American Society of
Clinical Oncology annual meeting
The FDA approved our Phase III clinical trial of GFH925 for the
treatment of refractory metastatic CRC patients
We initiated our Phase I clinical trial of GFH375, an orally
bioavailable small molecule inhibitor of KRAS G12D, in China
We completed series C+ financing with investors including Asia
Investment Capital, Huajin Capital, Tailong Investment and
Jiangmen Qishun, in an aggregate amount of approximately
RMB195 million
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Y ear Milestone
2025 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118NMPA accepted our Breakthrough Therapy Designation (BTD)
application with respect to GFH375 for the treatment of PDAC
NMPA granted IND approval in China in relation to GFS202A for
a Phase I study treating cancer cachexia patients
Our IND application with respect to GFH276, an oral novel
small-molecule Pan RAS (ON) inhibitor was submitted to the
NMPA
OUR SUBSIDIARIES
The principal business activities and the dates of incorporation of all of our subsidiaries
(all of which are wholly-owned) are as follows:
Name of major
subsidiary
Place of
incorporation
Date of incorporation
and commencement
of business
Principal business
activities
GenFleet Zhejiang /H1118/H1118/H1118PRC April 8, 2018 Research and
development of
innovative drugs
GenFleet U.S. /H1118/H1118/H1118/H1118/H1118/H1118U.S. April 13, 2020 Research and
development of
innovative drugs
GenFleet Australia /H1118/H1118/H1118Australia July 15, 2020 Research and
development of
innovative drugs
GenFleet Hangzhou /H1118/H1118PRC September 26, 2023 Technical services,
technology
development and
production of drugs
GenFleet Zhuhai /H1118/H1118/H1118/H1118PRC November 1, 2023 Technical services,
technology
development and
production of drugs
GenFleet Shanghai /H1118/H1118/H1118PRC March 30, 2021 No substantial
business activities
GenFleet Beijing /H1118/H1118/H1118/H1118PRC February 22, 2022 No substantial
business activities
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CORPORATE DEVELOPMENT AND MAJOR SHAREHOLDING CHANGES
(1) Establishment of our Company
On August 23, 2017, our Company was established as a limited liability company under
the laws of the PRC, with an initial registered capital of RMB5,000,000. The shareholding
structure of our Company upon establishment is set forth in the table below:
Beneficial Shareholders
Registered capital
subscribed for
Corresponding
equity interest in
our Company
(RMB) (%)
GenFleet HK (Note 1) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,540,000 90.8
Ms. Zhang (Note 2) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118460,000 9.2
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,000,000 100.0
Notes:
1. GenFleet HK was held as to 54% by Dr. Lu and 46% by Dr. Lan when our Company was established
on August 23, 2017. On October 11, 2017, each of Dr. Lu and Dr. Lan transferred 300 shares and 200
shares of GenFleet HK to Snow Owl, LLC (“ Snow Owl ”), upon which GenFleet HK was held as to 51%,
44% and 5% by Dr. Lu, Dr. Lan and Snow Owl, respectively. Snow Owl is an Independent Third Party.
It is an early investor of the Company invested in the Company indirectly through GenFleet HK. It is
a private investor and was not involved in the day-to-day management of the Company nor GenFleet
HK. After a series of shareholding changes, since August 2023, GenFleet HK was held as to 53.69% by
Dr. Lu and 46.31% by Dr. Lan.
2. Ms. Zhang is an executive Director and member of the senior management of our Company, and an
initial subscriber of our Company when our Company was established. The equity interests of our
Company were held by Ms. Zhang for subsequent share incentive purpose. Pursuant to an equity transfer
agreement dated October 24, 2017, Ms. Zhang transferred her equity interests held in our Company to
Shanghai Kunjue, our ESOP Platform, at nil consideration.
(2) Overview of Pre-IPO Investments
Our Company entered into several rounds of Pre-IPO Investments pursuant to the
respective capital increase agreements with our Pre-IPO Investors. For details, see “— Pre-IPO
Investments” in this section.
Apart from such capital increases, since our incorporation, there were also equity
transfers between our Pre-IPO Investors and members of our Single Largest Group of
Shareholders. As at the Latest Practicable Date, our Single Largest Group of Shareholders had
transferred an insignificant portion of the equity interests that represented an aggregate
registered capital of RMB1.41 million to various Pre-IPO Investors. The last round of equity
transfers between our Single Largest Group of Shareholders and the Pre-IPO Investors were
completed in January 2024, whereby GenFleet HK transferred registered capital of our
Company in an aggregate amount of RMB627,536.93 to our Pre-IPO Investors at an aggregate
consideration of approximately RMB57.25 million.
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(3) Conversion into a joint stock limited company
On June 28, 2024, our then Shareholders passed resolutions approving, among other
matters, the conversion of our Company from a limited liability company into a joint stock
limited company and the change of name of our Company to GenFleet Therapeutics (Shanghai)
Inc. (Ҧ(ɪऎ)ʮ̡). Pursuant to the promoters’ agreement dated July 25,
2024 entered into by all the then Shareholders, all promoters approved the conversion of the
net assets value of our Company as of March 31, 2024 into 26,774,063 Shares of our Company,
with the remaining RMB733,504,174.20 in net assets included as capital reserves of our
Company. Upon completion of the conversion, the registered capital of our Company became
RMB26,774,063 divided into 26,774,063 Shares with a nominal value of RMB1.00 each, which
were subscribed by all the then Shareholders in proportion to their respective equity interests
in our Company before the conversion. The conversion was completed on September 29, 2024
when our Company obtained a new business license. Immediately after the conversion into a
joint stock company, the Company is held by the following shareholders who acted as
promoters for the purpose of the stock conversion of our Company. The information of our
promoters is set forth as follows:
Shareholders Number of Shares
Ownership
percentage
GenFleet HK /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,372,465 16.3309%
Ourea Biotech HK Limited /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,505,596 9.3583%
Long Star Growth Group Limited (ණྠ
ʮ̡)/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,509,115 5.6365%
Shanghai Kunjin /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,383,607 5.1677%
Hongyong Bingde (Hong Kong) Limited (٢
ᅃ(ಥ)ʮ̡) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,317,182 4.9196%
Ningbo Huiqiao Hongjia V enture Capital
Partnership (Limited Partnership) (ි዗̾
͠௴ุҳ༟ΥྫΆุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,150,894 4.2985%
Auspicious Delight /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,000,000 3.7350%
Sinopharm (Shanghai) Biological Equity
Investment Fund Partnership (Limited
Partnership) ( ਷ᖹʕ͛(ɪऎ)ږ
ΥྫΆุ(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118947,615 3.5393%
Shenzhen Hongtu Healthcare Industry Equity
Investment Fund Partnership (Limited
Partnership) (ᛆҳ༟ਿ
ΥྫΆุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118896,012 3.3466%
Capital Health Industry (Beijing) Fund (Limited
Partnership) (ேɽ਄ੰପุ(̏ԯ)ږ(Υ
ྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118746,755 2.7891%
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Shareholders Number of Shares
Ownership
percentage
Beijing Huagai Xincheng Y uanhang Medical
Industry Investment Partnership (Limited
Partnership) (༐Ⴣঘᔼᐕପุҳ༟Υ
ྫΆุ(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118746,755 2.7891%
Guangzhou Chenhui V enture Capital Fund
Partnership Enterprise (Limited Partnership) ( ᄿ
ΥྫΆุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118564,325 2.1077%
Xiamen Zhongnan Hongyuan Equity Investment
Fund Partnership (Limited Partnership) (ʕ
ΥྫΆุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118487,719 1.8216%
Zhuhai Huajin Lingjian Equity Investment Fund
Partnership (Limited Partnership) (ჯ
ΥྫΆุ(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118470,271 1.7564%
Hangzhou Taikun Equity Investment Fund
Partnership (Limited Partnership) (ٰ
ΥྫΆุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118470,271 1.7564%
Shanghai Panlong V enture Capital Partnership
(Limited Partnership) ( ɪऎᇂᗬ௴ุҳ༟ΥྫΆ
ุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118448,006 1.6733%
Hangzhou Jingxin V enture Capital Partnership
(Limited Partnership) (ψᗝː௴ุҳ༟ΥྫΆ
ุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118448,006 1.6733%
CSPC NBP Pharmaceutical Co., Ltd. (ࢸ
ʮ̡)/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118441,176 1.6478%
Beta Achieve Limited /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118406,919 1.5198%
Shanghai Y uhan Equity Investment Fund
Partnership (Limited Partnership) (ٰ
ΥྫΆุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118402,956 1.5050%
Shijiazhuang High-Tech Zone Pu’en Guoxin
Equity Investment Centre (Limited Partnership)
(ᛆҳ༟ʕː(Υ
ྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118395,607 1.4776%
Shaoxing Haibang Caizhi V enture Capital
Partnership (Limited Partnership) ( ୗጳऎԞʑ
౽௴ุҳ༟ΥྫΆุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118348,788 1.3027%
Shanghai Taiyi V enture Capital Partnership
(Limited Partnership) (
ɪऎइӥ௴ุҳ༟ΥྫΆ
ุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118339,919 1.2696%
Shaoxing Haibang Talent V enture Capital
Partnership (Limited Partnership) ( ୗጳऎԞɛ
ʑ௴ุҳ༟ΥྫΆุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118322,129 1.2031%
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Shareholders Number of Shares
Ownership
percentage
Huimei Jiankang Haihe (Tianjin) Private Equity
L.P . (ئ(ݵ)ΥྫΆุ
(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118307,213 1.1474%
Faithful Way Investment Limited (ʮ
̡) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118295,885 1.1051%
LBC Sunshine Healthcare Fund II L.P . /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118294,024 1.0982%
Suzhou Jichuang Xinyuan V enture Capital
Partnership (Limited Partnership) (ؚ
๕௴ุҳ༟ΥྫΆุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118290,557 1.0852%
Guangzhou Chentu No. 14 V enture Capital Fund
Partnership Enterprise (Limited Partnership) ( ᄿ
ΥྫΆุ(Υ
ྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118280,017 1.0459%
Xiamen Dyee Evergreen V enture Capital
Partnership (Limited Partnership) (ڗ
௴ุҳ༟ΥྫΆุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118280,017 1.0459%
Jiaxing Runji Equity Investment Partnership
(Limited Partnership) (ᛆҳ༟ΥྫΆ
ุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118232,525 0.8685%
Suqian Lingdao Shengming Changqing Equity
Investment Partnership (Limited Partnership)
(ᛆҳ༟ΥྫΆุ(Υ
ྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118192,661 0.7196%
BOCOM Sci-Tech Innovation Equity Investment
Fund (Shanghai) Partnership (Limited
Partnership) (ږ(ɪऎ)Υྫ
Άุ(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118189,048 0.7061%
Suzhou Suxin Guokang V enture Capital
Partnership (Limited Partnership) (ڦ
਷ੰ௴ุҳ༟ΥྫΆุ(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186,695 0.6973%
Suzhou Suxin Junnuo V enture Capital Partnership
(Limited Partnership) (ёፕ௴ุҳ༟
ΥྫΆุ(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186,695 0.6973%
Suzhou Jingtian Medical Investment Partnership
(Limited Partnership) ( ᘽψ౻˂ᔼᐕҳ༟ΥྫΆ
ุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186,695 0.6973%
BV Fund II L.P . /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186,695 0.6973%
Hangzhou Panlin Xukang V enture Capital
Partnership (Limited Partnership) (ψᇂᎌϛ
ੰ௴ุҳ༟ΥྫΆุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186,695 0.6973%
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Shareholders Number of Shares
Ownership
percentage
Qingdao Shanjin Anjia Equity Investment
Partnership (Limited Partnership) (τ
ᛆҳ༟ΥྫΆุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186,695 0.6973%
Zhuzhou Wenzhou Junzhe V enture Capital
Partnership (Limited Partnership) (̹˖մ
ё䂮௴ุҳ༟ΥྫΆุ(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186,695 0.6973%
Qingdao Panlin Hongyu V enture Capital
Partnership (Limited Partnership) (ᇂᎌᒿ
༃௴ุҳ༟Άุ(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118174,394 0.6514%
Shenzhen Capital Group Co., Ltd. ( ଉέ̹௴อҳ
ʮ̡) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118149,335 0.5578%
Jiangmen Qishun Technology Partnership (Limited
Partnership) (ҦΥྫΆุ(Υ
ྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118149,335 0.5578%
Guangzhou Chentu No. 15 V enture Capital Fund
Partnership Enterprise (Limited Partnership) ( ᄿ
ΥྫΆุ(Υ
ྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118140,021 0.5230%
Chongqing Jichuang Fengyuan Private Equity
Investment Fund Partnership (Limited
Partnership) (Υ
ྫΆุ(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118116,362 0.4346%
Suzhou Suxin Qikang V enture Capital Partnership
(Limited Partnership) (઼ੰ௴ุҳ༟
ΥྫΆุ(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111893,347 0.3486%
Nantong Ruiyi Equity Investment Partnership
(Limited Partnership) (ᛆҳ༟ΥྫΆ
ุ(Υྫ))/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111893,347 0.3486%
Hangzhou Y antong Investment Partnership
(Limited Partnership) (ҳ༟ΥྫΆุ
(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111858,131 0.2171%
Shanghai Shengcheng Investment Management
Partnership (Limited Partnership) ( ɪऎ໋ϓҳ
༟၍ଣΥྫΆุ(Υྫ)) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,891 0.0332%
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111826,774,063 100.00%
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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(4) Share Subdivision before the Listing
Pursuant to the resolutions of the Shareholders dated December 3, 2024, the Shares will
be split on a one-for-ten basis immediately prior to the Listing, and the nominal value of the
Shares will be changed from RMB1.0 each to RMB0.1 each. Immediately after the Share
Subdivision, the registered share capital of the Company will be RMB26,774,063 with
267,740,630 Shares in a nominal value of RMB0.1 each.
COMPLIANCE WITH PRC LA WS AND REGULATION
Our PRC Legal Advisor confirmed that all material regulatory approvals in relation to the
equity transfers, conversion into joint stock limited company and the capital increases as
described in this section were properly and legally completed and all necessary approvals,
filings and registrations from the relevant PRC authorities have been obtained and completed.
MAJOR ACQUISITIONS AND INVESTMENTS
We have not conducted any acquisitions, disposals or mergers since our inception that we
consider to be material to us.
CONCERT PARTY AGREEMENT
Dr. Lu and Dr. Lan shared the same values and goals, as well as the belief in our
prospects. Since the establishment of the Company, as the co-founders of the Group, they have
decided to act in concert in respect of the decision making at the Board meeting level and
Shareholders’ meeting level relating to the business operation and major issues of the
Company. Dr. Lu, Dr. Lan, GenFleet HK, Shanghai Kunjin, Shanghai Kunjue and Auspicious
Delight entered into the currently effective concert party agreement dated March 25, 2022 (for
the purpose of replacing the previous versions of the concert party agreements as Shanghai
Kunjin was established in April 2021 as a new ESOP Platform, which therefore joined as a
party to the concert party agreement) (the “ Concert Party Agreement ”). Pursuant to the
Concert Party Agreement, the parties acknowledged and confirmed their relationship of acting
in concert in exercising the rights of the Shareholders and Directors of the Company. In the
event the parties are unable to reach consensus on matters of our Company, each of the parties
shall act in accordance with the instructions of Dr. Lu. The Concert Party Agreement shall
remain effective until 36 months after the Listing Date. Notwithstanding Dr. Lu is the sole
general partner of, and is able to control and exercise the voting rights attached to, each of
Shanghai Kunjin and Shanghai Kunjue, Shanghai Kunjin and Shanghai Kunjue joined as
parties to the Concert Party Agreement as (i) Shanghai Kunjin is a Shareholder of the Company
and (ii) Shanghai Kunjue had been a party to the historical concert party agreement, and thus
remained as a party to the Concert Party Agreement.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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REASONS FOR THE LISTING
Our Company is seeking a Listing of its H Shares on the Stock Exchange in order to
provide further capital for the development and expansion of our Company’s business, to
strengthen our Company’s working capital and to further raise our business profile and global
presence. For further details of our future plans, see “Future Plans and Use of Proceeds.”
OUR ESOP PLATFORMS
In recognition of the contributions of our employees and to incentivize them to further
promote our development, we adopted the Pre-IPO Equity Incentive Scheme in 2020 as
amended and restated in July 2023. The Pre-IPO Equity Incentive Scheme shall be
administered by the department designated by the Board. The Board shall have the right to,
among others, (i) interpret and construe the provisions of the Pre-IPO Equity Incentive
Scheme, (ii) determine the persons who will be granted awards under the Pre-IPO Equity
Incentive Scheme and the relevant terms of the awards, (iii) amend any of the provisions of the
Pre-IPO Equity Incentive Scheme, (iv) terminate the Pre-IPO Equity Incentive Scheme, and (v)
make such other decisions or determinations as it shall deem appropriate in the administration
of the Pre-IPO Equity Incentive Scheme.
Our ESOP Platforms include (i) Shanghai Kunjin, a limited partnership established in the
PRC on April 2, 2021, holding 5.1677% of the issued Shares as at the Latest Practicable Date,
(ii) Shanghai Kunjue and Shanghai Kunqian, each being a limited partner of Shanghai Kunjin
holding approximately 20.60% and 7.19% limited partnership interests of Shanghai Kunjin as
at the Latest Practicable Date, respectively; and (iii) Auspicious Delight, a limited company
incorporated in the BVI on May 25, 2018, holding 3.7350% of the issued Shares as at the Latest
Practicable Date. The Company established Auspicious Delight to facilitate the vesting of
awards of grantees under the Pre-IPO Equity Incentive Scheme who are non-PRC employees.
The Company further established three ESOP Platforms (including Shanghai Kunjue, Shanghai
Kunjin and Shanghai Kunqian) to facilitate the vesting of awards of grantees under the Pre-
IPO Equity Incentive Scheme who are PRC employees. Different ESOP Platforms were
established having considered, among others, (i) there is restriction on the maximum number
of limited partners in a limited partnership and (ii) for the ease of management to register the
partnership interests accordingly based on the different terms of the share incentives granted
to the grantees.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Shanghai Kunjin
The sole general partner of Shanghai Kunjin is Dr. Lu, who manages the day-to-day
affairs and exercise the voting rights of Shanghai Kunjin. Therefore, in effect, all management
powers and voting rights of Shanghai Kunjin reside with Dr. Lu as the sole general partner. Our
Company had granted awards to selected participants under the Pre-IPO Equity Incentive
Scheme for (i) direct limited partnership interests in Shanghai Kunjin, and (ii) indirect limited
partnership interests in Shanghai Kunjin (i.e. limited partnership interests in Shanghai Kunjue
and Shanghai Kunqian, each of which is a limited partner of Shanghai Kunjin) corresponding
to underlying H Shares of the Company. Dr. Lu is also the sole general partner of each of
Shanghai Kunjue and Shanghai Kunqian, who is able to exercise the voting rights attached to
Shanghai Kunjue and Shanghai Kunqian.
As of the Latest Practicable Date, Dr. Lu held approximately 0.04% partnership interests
in Shanghai Kunjin, 1.00% partnership interests in Shanghai Kunjue, and 0.50% partnership
interests in Shanghai Kunqian. The remaining partnership interests of Shanghai Kunjin were
held by 47 limited partners of Shanghai Kunjin, namely (i) Shanghai Kunjue (holding
approximately 20.60% partnership interests of Shanghai Kunjin), (ii) Shanghai Kunqian
(holding approximately 7.19% partnership interests of Shanghai Kunjin), (iii) five connected
persons of our Company, including Ms. Zhang, our executive Director (holding approximately
4.88% interests of Shanghai Kunjin), Mr. Lin Chonglan and Ms. Ma Rui, each a Supervisor
(holding approximately 0.58% and 0.80% interests of Shanghai Kunjin respectively), and Dr.
Wang Y u and Dr. Shen Haige, each a current employee and also a former director of our
Company in the last 12 months before the Listing Date (holding approximately 14.82% and
5.06% interests of Shanghai Kunjin respectively), and (iv) other 40 current employees who are
not Directors, Supervisors or connected persons of our Company (holding in aggregate
approximately 46.03% interests of Shanghai Kunjin). None of the limited partners of Shanghai
Kunjin held more than 30% or more of the partnership interests in Shanghai Kunjin.
The remaining partnership interests of Shanghai Kunjue were held by 22 limited partners
of Shanghai Kunjue, namely (i) four connected persons of our Company, including Ms. Zhang,
our executive Director (holding approximately 4.38% interests of Shanghai Kunjue), Mr. Lin
Chonglan, a Supervisor (holding approximately 0.70% interests of Shanghai Kunjue), and Dr.
Wang Y u and Dr. Shen Haige, each a current employee and also a former director of our
Company in the last 12 months before the Listing Date (holding approximately 43.86% and
17.54% interests of Shanghai Kunjue respectively), and (ii) other 18 current employees who
are not Directors, Supervisors or connected persons of our Company (holding in aggregate
approximately 32.52% interests of Shanghai Kunjue). Save as disclosed above, none of the
limited partners of Shanghai Kunjue held more than 30% or more of the partnership interest
in Shanghai Kunjue.
The remaining 99.50% partnership interests of Shanghai Kunqian were held by 16 limited
partners of Shanghai Kunqian, all of whom are current employees who are not Directors,
Supervisors or connected persons of our Company. None of the limited partner of Shanghai
Kunqian held more than 30% or more of the partnership interest in Shanghai Kunqian.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Auspicious Delight
As of the Latest Practicable Date, four current employees, including (i) three employees
who are not the Directors, Supervisors or connected persons of our Company (holding 19.5%
of the issued share capital of Auspicious Delight in aggregate) and (ii) Dr. LI Jingrong, who
is also a former director of our Company in the last 12 months before the Listing Date (holding
approximately 16.0% of the issued share capital of Auspicious Delight) had their awards vested
through Auspicious Delight. The rest of the issued share capital of Auspicious Delight,
representing 64.5% of the issued share capital of Auspicious Delight were held by GenFleet
HK. Such issued share capital of Auspicious Delight held by GenFleet HK will not be further
granted to other grantees under the Pre-IPO Equity Incentive Scheme.
As of the Latest Practicable Date, there were 66 grantees under the Pre-IPO Equity
Incentive Scheme, and all awards granted under the Pre-IPO Equity Incentive Scheme had been
vested and exercised and no further awards will be granted under the Pre-IPO Equity Incentive
Scheme upon Listing.
PRE-IPO INVESTMENTS
Our Company entered into several rounds of Pre-IPO Investments pursuant to the
respective capital increase agreements with our Pre-IPO Investors.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Principal Terms of the Pre-IPO Investments and Pre-IPO Investors’ Rights
The following table summarizes the key terms of the Pre-IPO Investments to our Company made by the Pre-IPO Investors:
Series Angel Series A Series A+ Series B (6) Series B+ Series C Series C+
Amount of registered capital/shares
acquired by Pre-IPO Investors /H1118/H1118/H1118
RMB2,500,000 RMB2,647,059 RMB322,129 RMB5,122,199 RMB2,156,401 RMB4,503,387 (4) RMB1,673,807
Amount of consideration paid /H1118/H1118/H1118/H1118RMB60,000,000 RMB120,000,000 RMB20,000,000 RMB343,000,000 RMB200,000,000 RMB482,450,000 RMB195,299,600
Implied post-money valuation /H1118/H1118/H1118/H1118RMB180,000,000 RMB460,000,000 (2) RMB650,000,000 RMB1,083,000,000 (3) RMB1,700,000,000 RMB2,662,450,000 (4) RMB3,123,994,600 (5)
Date of agreement(s) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118November 13, 2017
and January 3, 2018
October 11, 2018,
November 21, 2018
and December 4,
2018
February 28, 2019 February 8, 2020 December 30, 2020 March 25, 2022 and
November 15,
2022
(4)
December 28, 2023
Date of payment of full
consideration /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
January 29, 2018 January 7, 2019 April 16, 2019 March 30, 2020 March 22, 2021 December 21, 2022 March 21, 2024
Cost per Share paid under the Pre-
IPO Investments (approximately)
(RMB) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
24.00 45.33 62.09 66.96 92.75 107.13 116.68
Discount to the Offer Price
(approximately)
(1) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
87.09% 75.62% 66.60% 63.98% 50.11% 42.38% 37.24%
Basis of determination of the
valuation and consideration /H1118/H1118/H1118/H1118
The considerations for each round of Pre-IPO Investments were determined based on arm’s length negotiation amongst the respective Pre-IPO Investor s and our Group after
taking into consideration of the timing of the investments, the status of our business operations, financial performance of our Group, and the prospe cts of our business.
Lock-up Period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Pursuant to the PRC Company Law, Shares issued by our Company prior to the Listing (including those held by the Pre-IPO Investors) will be subject to a lo ck-up period of
one year from the Listing Date.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Series Angel Series A Series A+ Series B (6) Series B+ Series C Series C+
Use of proceeds from the Pre-IPO
Investments /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
We utilized the proceeds, and expect to continue to utilize the unutilized proceeds from the Pre-IPO Investments, for the principal business of our Gr oup, including but not
limited to research and development of our products, the growth and expansion of our business and general working capital purposes. As of the Latest Pr acticable Date, we
have utilized approximately 75% of the proceeds from the Pre-IPO Investments.
Strategic benefits to our Company
brought by the Pre-IPO Investors /H1118
At the time of the Pre-IPO Investment, we believed that our Group could benefit from the additional funds raised from the Pre-IPO Investments as well as their knowledge
and experience.
Notes:
(1). Calculated based on the Offer Price of HK$20.39 per H Share.
(2). The increase in the valuation of the Company in Series A investment compared with Series Angel investment was due to the research and development p rogress we achieved
in our drug candidates. In particular, we commenced our endeavor to discover and develop GFH018.
(3). The valuation of the Company increased in Series B investment compared with Series A investment as a result of the progress we made in our research a nd development, as
we submitted our first IND application in China in 2019 within 19 months after our establishment. Further, the market was optimistic about the future d evelopment of
KRAS G12C, in particular having considered the results of the first-in-human clinical trial of KRAS G12C presented at the 2019 American Society of Cli nical Oncology annual
meeting.
(4). The implied post-money valuation of Series C investment has taken into account (i) the subscription of a total of RMB3,889,673 registered capita l of the Company by the Pre-IPO
Investors at a consideration of RMB482,450,000 and (ii) the transfer of a total of RMB613,714 registered capital of the Company by Shanghai Kunjin (ou r ESOP Platform)
to the relevant Pre-IPO Investors in Series C investment, each at a consideration of RMB1. The increase in the valuation of the Company in Series C inves tment compared with
Series B investment was due to the research and development progress we achieved in our drug candidates. In particular, we commenced our Phase I clinic al trial of GFH312
in Australia and arranged eight clinical sites in multiple provinces in China, and activated one clinical trial site in 2021 in preparation for the cli nical trial of GFH925 in China.
We also received the IND approval in China and the United States with respect to GFH009.
(5). The increase in the valuation of the Company in Series C+ investment compared with Series C investment was due to the research and development prog ress we achieved in
our drug candidates. In particular, NDA with respect to our GFH925 was submitted and our GFH925 monotherapy received two Breakthrough Therapy Design ations from the
NMPA for treating advanced KRAS G12C-mutant NSCLC and CRC patients. We also entered into collaboration agreement with SELLAS in relation to the co-de velopment of
GFH009.
(6). As at the Latest Practicable Date, the market capitalization of the Company upon completion of the Global Offering is expected to be approximatel y HK$7,041.5 million (based
on the Offer Price of HK$20.39, assuming the Offer Size Adjustment Option and the Over-Allotment Option are not exercised). The increase in the valuat ion of the Company
upon Listing since Series C+ investment was due to the business growth of our Company, in particular, we have started generating sales revenue from the supply of GFH925
to Innovent in 2024. Further, we have also achieved significant research and development progress in our drug candidates. For example, the FDA approv ed our Phase III clinical
trial of GFH925 for the treatment of refractory metastatic CRC patients in April 2024, GFH925 (marketed under the name Dupert
®) was approved by NMPA for the treatment
of patients with advanced NSCLC harboring KRAS G12C mutation who have received at least one systemic therapy in August 2024, and NMPA accepted our Brea kthrough
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Therapy Designation (BTD) application with respect to GFH375 for the treatment of PDAC and we submitted our IND application with respect to GFH276, an oral novel
small-molecule Pan RAS (ON) inhibitor to NMPA in June 2025. In addition, we submitted an IND application for a Phase II clinical trial of GFH312 for the t reatment of PBC
to the NMPA in March 2025 and obtained NMPA ’s approval in May 2025. The increase in valuation upon the completion of the Global Offering has also taken in to account
the potential business development of the Company, the increased liquidity of the Shares subsequent to the Listing, and the current market condition s.
(7). Prior to the Series B Pre-IPO Investment, on January 18, 2020, a capital increase agreement was entered into by and among others, our Company and ou r then Shareholders,
pursuant to which Ourea Biotech, Shanghai Y uhan, Shanghai Taiyi, Ningbo Hongjia, Sinopharm, Shanghai Shengcheng and Pu’en Guoxin, each of which (ex cept Pu’en Guoxin)
is a then Shareholder of our Company, collectively agreed to subscribe for registered capital in the aggregate amount of RMB581,622 of our Company at a n aggregate
consideration of RMB30,000,000.
(8). In April 2025, Suzhou Apricot Xingyong Emerging Medical Industry Investment Fund Management Partnership (Limited Partnership) (၍
ଣΥྫΆุ(Υྫ)) (“ Suzhou Apricot ”) entered into equity transfer agreements with each of Faithful Way Investment Limited (“ Faithful Way Investment ”), Ourea Biotech
HK Limited, Shanghai Y uhan Equity Investment Fund Partnership (Limited Partnership) (ΥྫΆุ(Υྫ)) (“ Shanghai Yuhan ”) and Ningbo Huiqiao
Hongjia V enture Capital Partnership (Limited Partnership) (ි዗̾͠௴ุҳ༟ΥྫΆุ(Υྫ)) (“ Ningbo Hongjia ”), pursuant to which Suzhou Aprico agreed to
acquire 177,531 Shares, 263,707 Shares, 71,254 Shares and 263,707 Shares from Faithful Way Investment, Ourea Biotech HK Limited, Shanghai Y uhan and Ningbo Hongjia
at a consideration of approximately RMB13.5 million, RMB20 million, RMB5.4 million and RMB20 million, respectively. The consideration of such shar e transfers was
completely settled on May 21, 2025.
In April 2025, Xiamen Zhongnan Hongyuan Equity Investment Fund Partnership (Limited Partnership) (ΥྫΆุ(Υྫ)) (“ Zhongnan
Hongyuan ”) entered into an equity transfer agreement with GF Qianhe Investment Co., Ltd. (ʮ̡)( “ GF Qianhe ”) and Qingding (Beijing) Management
Consulting Partnership (Limited Partnership) ( Ꮧཻ(̏ԯ)၍ଣፔ༔ΥྫΆุ(Υྫ)) (“ Qingding Beijing ”), pursuant to which Zhongnan Hongyuan agreed to transfer
476,496 Shares and 11,223 Shares GF Qianhe and Qingding Beijing at a consideration of approximately RMB35 million and RMB0.8 million, respectively. The consideration
of such share transfers was completely settled on April 16, 2025.
The considerations of the above equity transfers were determined after arm’s length negotiations between the relevant parties, with reference to, a mong others, the investment
cost of subscribing for such registered capital in our Company paid by the transferors (in particular, having considered the increase in the valuatio n of our Company since their
respective initial investment in our Company), the funding needs and investment plan of the transferors, the business growth prospect of our Company and the valuation of our
Company in the Series C+ investment.
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Rights of the Pre-IPO Investors
Pursuant to the shareholders agreement and capital increase agreement dated December
28, 2023, the Pre-IPO Investors were granted customary special rights, including but not
limited to redemption rights, liquidation rights, right of first refusal, anti-dilution rights, and
directors nomination rights. Pursuant to a supplemental agreement entered into by our
Company with, among others, the then Shareholders of the Company dated November 30,
2024, (a) the redemption rights and the related compulsory liquidation right of the Pre-IPO
Investors shall be terminated on the day before the submission of the application for an initial
public offering to the Hong Kong Stock Exchange by the Company (the “ Listing
Application ”), subject to reinstatement in the event of (i) the Listing Application not being
accepted (including being rejected or returned); (ii) the Company withdrawing its Listing
Application; (iii) the Company failing to complete the Listing within two years after date of
the Listing Application; or (iv) the Listing Committee not approving the Listing Application
(the “ Reinstatement ”); and (b) all of the other special rights shall be terminated completely
from the Listing Date.
Sole Sponsor’s Confirmation
On the basis that (i) the considerations for the Pre-IPO Investments were settled at least
120 clear days before the Listing Date, (ii) the redemption rights and the related compulsory
liquidation right of the Pre-IPO Investors shall be terminated on the day before the submission
of the Listing Application subject to the Reinstatement, and (iii) all the special rights granted
to the Pre-IPO Investors shall cease to be effective and be terminated before the Listing, the
Sole Sponsor confirms that the Pre-IPO Investments are in compliance with the Pre-IPO
Investment Guidance in Chapter 4.2 of the Guide for New Listing Applicants.
Information about our Pre-IPO Investors
Ourea Biotech (details of which are set out under “HighLight Capital” below) is our
Sophisticated Investor. To the best knowledge of our Directors, save as disclosed below, each
of our Pre-IPO Investors and their respective ultimate beneficial owner (where applicable) is
an Independent Third Party. Set out below are details of our Pre-IPO Investors.
HighLight Capital
Ourea Biotech HK Limited (“ Ourea Biotech ”) is a limited liability company incorporated
in Hong Kong on May 22, 2017 and is wholly owned by HL Partners II L.P ., a limited
partnership established under the laws of the Cayman Islands. The general partner of HL
Partners II L.P . is HL GP II Company Limited, which is owned as to 91.25% by Mr. Wang,
Stephen Hui ( ˮฯ), an Independent Third Party to the Company. None of the limited partners
of HL Partners II L.P . holds one-third or more of its partnership interests.
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Ourea Biotech invested in the Company in December 2017. It is a dedicated healthcare
and biotech fund controlled by HL Partners II L.P ., an investment fund operated under
HighLight Capital principally focusing on investment opportunities in medical and healthcare
and related industries. The value of assets under management of HL Partners II L.P ., and other
investment funds under the control of Mr. Wang, Stephen Hui as of December 31, 2024,
exceeds US$2.5 billion. The investment portfolio of HL Partners II L.P . in the medical and
healthcare and related industries include, among others, Zylox-Tonbridge Medical Technology
Co., Ltd. (a company listed on the Hong Kong Stock Exchange, stock code: 2190), Kintor
Pharmaceutical Limited (a company listed on the Hong Kong Stock Exchange, stock code:
9939) and Chemclin Diagnostics Co., Ltd. (a company listed on the Shanghai Stock Exchange,
stock code: 688468). Ourea Biotech is therefore a Sophisticated Investor.
CDH Investments
Long Star Growth Group Limited (ʮ̡)( “ Long Star ”), a company
incorporated in Hong Kong with limited liability, is indirectly wholly owned by CDH Growth
Fund III (USD Parallel), L.P ., a limited partnership registered in the Cayman Islands. The
general partner of CDH Growth Fund III (USD Parallel), L.P . is CDH R-III Parallel Holdings
Company Limited (together with its affiliates, “ CDH Investments ”), which is ultimately
controlled by Wu Shangzhi (қ), an Independent Third Party. Wu Shangzhi indirectly
controls 26.97% of the equity interests of CDH R-III Parallel Holdings Company Limited. No
other shareholders controls one-third or more of the equity interests in CDH R-III Parallel
Holdings Company Limited.
CDH Investments is an asset management group focusing on investment in China. From
its roots in private equity, CDH Investments has expanded to become a diversified alternative
asset management platform covering private equity, venture and growth capital, mezzanine &
credit, public equities and real estate. The investment portfolio of CDH Investments in the
medical and healthcare and related industries include, among others, Wuhan YZY Biopharma
Co., Ltd. (a company listed on the Hong Kong Stock Exchange, stock code: 2496), SciClone
Pharmaceuticals (Holdings) Limited (a company listed on the Hong Kong Stock Exchange,
stock code: 6600) and HitGen Inc. (ʮ̡) (a company listed on the
Shanghai Stock Exchange, stock code: 688222).
Huagai Capital
Beijing Huagai Xincheng Y uanhang Medical Industry Investment Partnership (Limited
Partnership) (༐Ⴣঘᔼᐕପุҳ༟ΥྫΆุ(Υྫ)) (“ Huagai Xincheng ”) is a
limited partnership incorporated under the laws of the PRC, with its general partner being
Huagai Medical Investment Management (Beijing) Co., Ltd. ( ശႊᔼᐕҳ༟၍ଣ(̏ԯ)ʮ
̡) which is effectively controlled and held as to 70% equity interests by Huagai Capital Co.,
Ltd. (ப΂ʮ̡), the ultimate controller of which is Xu Xiaolin (؍an
Independent Third Party. Huagai Xincheng has more than 30 partners, and none of any of the
partners holds one-third or more of the partnership interests.
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Capital Health Industry (Beijing) Fund (Limited Partnership) (ேɽ਄ੰପุ(̏ԯ)ږ
(Υྫ)) (“ Capital Health ”) is a limited partnership incorporated under the laws of the
PRC. Its general partner is Bei Guang Huagai Consulting Management (Beijing) Co., Ltd. ( ̏
ᄿശႊፔ༔၍ଣ(̏ԯ)ʮ̡), which is held as to 35% respectively by Huagai Medical
Investment Management (Beijing) Co., Ltd. ( ശႊᔼᐕҳ༟၍ଣ(̏ԯ)ʮ̡) and Beijing
Broadcasting Group Co., Ltd. (ʮ̡) (ultimately controlled by Beijing Radio
and Television Station, a public institution directly under the Beijing municipal government).
Capital Health has more than 10 partners, and none of whom holds one-third or more of the
partnership interests.
Huagai Xincheng and Capital Health are investment funds of Huagai Capital ( ശႊ༟͉),
which focuses on private equity investments in the two major fields of healthcare and
technology. The investment portfolio of Huagai Capital in the medical and healthcare and
related industries include, among others, Antengene Corporation Limited (a company listed on
the Hong Kong Stock Exchange, stock code: 6996), Hygeia Healthcare Holdings Co., Limited
(a company listed on the Hong Kong Stock Exchange, stock code: 6078) and Shanghai Henlius
Biotech, Inc. (a company listed on the Hong Kong Stock Exchange, stock code: 2696).
Asia Investment Capital
Hongyong Bingde (Hong Kong) Limited (ᅃ(ಥ)ʮ̡)( “ Hongyong
Bingde ”) is a private limited liability company incorporated in Hong Kong and is wholly-
owned by Hongyong Bingde Capital (Cayman) Limited. Hongyong Bingde Capital (Cayman)
Limited is owned as to approximately 99% by Asia Ascent Holding (Cayman) Ltd., which is
in turn wholly owned by Asia Investment Limited Partnership Fund (ږ.)
The general partner of Asia Investment Limited Partnership Fund is Asia Investment Capital
Limited (ʮ̡), and none of the limited partners of Asia Investment Limited
Partnership Fund owns more than one-third of its partnership interests. Asia Investment Capital
Limited is a wholly-owned subsidiary of AIC Holdings Limited (ʮ̡). AIC
Holdings Limited is held as to 43.13% by Liu Erh Fei (࠭an Independent Third Party,
and none of its other shareholders holds one-third or more of its equity interests. Each of the
limited partners of Asia Investment Limited Partnership Fund (ږi sa n
Independent Third Party. The investment portfolio of Asia Investment Capital include, among
others, Innovation New Material Technology Co., Ltd. (ʮ̡),
WeRide Inc., and Hive Box Holdings Limited (ʮ̡).
Shenzhen Capital
Shenzhen Hongtu Healthcare Industry Equity Investment Fund Partnership
(Limited Partnership) (ΥྫΆุ(Υྫ)) (“ Shenzhen
Hongtu ”) is a limited partnership established under the laws of the PRC, with its general
partner being Shenzhen City Hongtu Gaocheng Investment Co., Ltd. (ɺ৷ϓҳ༟Ϟ
ʮ̡), whose de facto controller is the State-owned Asset Supervision and Administration
Commission of the Shenzhen Municipal People’s Government and is held as to 95.00% by
Shenzhen V enture Capital Hongtu Private Equity Investment Fund Management (Shenzhen)
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Co., Ltd. (၍ଣ(ଉέ)ʮ̡). Shenzhen V enture Capital
Hongtu Private Equity Investment Fund Management (Shenzhen) Co., Ltd. is a wholly-owned
subsidiary of Shenzhen Capital Group Co., Ltd. (ʮ̡)( “ Shenzhen
Capital ”). None of any partners of Shenzhen Hongtu holds one-third or more of the partnership
interests. Shenzhen Hongtu is engaged in investments in the medical and healthcare industry
of the PRC and its investment portfolio include, among others, OrbusNeich Medical Group
Holdings Limited (a company listed on the Hong Kong Stock Exchange, stock code: 6929),
Nanjing Leads Biolabs Co., Ltd. (ʮ̡) and Shanghai
Zhimeng Biopharma Inc. (ʮ̡).
Shenzhen Capital is a limited liability company incorporated in the PRC, initially
co-founded by the Shenzhen Municipal People’s Government and a group of private
shareholders in 1999, approximately 28.20% of equity of which is currently held by its largest
shareholder and de facto controller, the State-owned Asset Supervision and Administration
Commission of the Shenzhen Municipal People’s Government. Shenzhen Capital currently is
a state-controlled and independently-managed investment institution concentrated on venture
capital, primarily investing in innovative high-tech companies in emerging industries at their
start-up, growth, or pre-IPO stages, including in IT, new media, medical, new energy,
environmental protection, chemical engineering, new materials, advanced manufacturing, and
consuming goods. The investment portfolio of Shenzhen Capital in the medical and healthcare
and related industries include, among others, Akeso, Inc. (a company listed on the Hong Kong
Stock Exchange, stock code: 9926), RemeGen Co., Ltd. (a company listed on the Hong Kong
Stock Exchange, stock code: 9995) and BGI Genomic Co., Ltd. (ʮ̡)
(a company listed on the Shenzhen Stock Exchange, stock code: 300676).
Cherami Sun Tour
Guangzhou Chentu No. 14 V enture Capital Fund Partnership Enterprise
(Limited Partnership) (ΥྫΆุ(Υྫ)) (“ Chentu No. 14 ”),
Guangzhou Chentu No. 15 V enture Capital Fund Partnership Enterprise (Limited Partnership)
(ΥྫΆุ(Υྫ)) (“ Chentu No. 15 ”) and Guangzhou
Chenhui V enture Capital Fund Partnership Enterprise (Limited Partnership) ( ᄿψԕሾ௴ุҳ
ΥྫΆุ(Υྫ)) (“ Guangzhou Chenhui ”) are all limited partnerships
incorporated under the laws of the PRC. The general partner of Chentu No. 14, Chentu No. 15,
and Guangzhou Chenhui is Guangzhou Cherami Sun Tour Equity Investment Management Co.,
Ltd. (ʮ̡)( “ Cherami Sun Tour ”), which is wholly owned
by Guangzhou Cherami Chenhui Investment Co., Ltd. (ʮ̡).
Guangzhou Cherami Chenhui Investment Co., Ltd. is owned as to approximately 90.00% by
Guangzhou Cherami Investment Group Co., Ltd. (ʮ̡), and is
ultimately controlled by Chen Ruibin ( ௓ቚ੸), an Independent Third Party to the Company.
Each of Chentu No. 14, Chentu No. 15, and Guangzhou Chenhui has more than 40 partners,
and none of any of the partners holds one-third or more of the partnership interests.
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Chentu No. 14, Chentu No. 15 and Guangzhou Chenhui are investment funds controlled
by Cherami Sun Tour, which focuses on three major industries: new energy,
semiconductors/new materials, and healthcare. The investment portfolio of Cherami Sun Tour
in the medical and healthcare and related industries include, among others, TINA VI Medical
Technologies Co., Ltd. (ʮ̡) (a company listed on the Shanghai
Stock Exchange, stock code: 688277), Mindrank AI Ltd. (ʮ̡) and
EnKang (Guangzhou) Pharmaceuticals, Ltd. (Ҧ(ᄿψ)ʮ̡).
Jianyi Capital
Sinopharm (Shanghai) Biological Equity Investment Fund Partnership (Limited
Partnership) ( ਷ᖹʕ͛(ɪऎ)ΥྫΆุ(Υྫ)) (“ Sinopharm ”) is a
limited partnership established under the laws of the PRC and its general partner, Shanghai
Jianyi Private Fund Management Co., Ltd. (ʮ̡) is held as to 65%
and controlled by Shanghai Shenghui Investment Management Partnership (Limited
Partnership) ( ɪऎ໋ිҳ༟၍ଣΥྫΆุ(Υྫ)), and as to 35% by China National
Pharmaceutical Investment Co., Ltd. (ʮ̡). Shanghai Shenghui Investment
Management Partnership (Limited Partnership) is ultimately controlled by an Independent
Third Party to the Company, Wu Aimin ( юฌ͏), holding 95.00% of its partnership equity.
None of any partners of Sinopharm holds one-third or more of the partnership interests.
Sinopharm is an investment fund operated under and managed by Jianyi Capital ( ਄ఠ༟
͉) focusing on investing in the medical healthcare sector. The value of assets under
management of Jianyi Capital exceeds RMB6.5 billion as of December 31, 2024. The
investment portfolio of Jianyi Capital in the medical healthcare and biotechnology sectors
includes, among others, Eyebright Medical Technology (Beijing) Co., Ltd. (a company listed
on the Shanghai Stock Exchange, stock code: 688050), Shenzhen YHLO Biotech Co., Ltd. (a
company listed on the Shanghai Stock Exchange, stock code: 688575) and Abbisko Cayman
Limited (a company listed on the Hong Kong Stock Exchange, stock code: 2256).
Apricot Capital
Suzhou Apricot Xingyong Emerging Medical Industry Investment Fund Management
Partnership (Limited Partnership) (၍ଣΥྫΆุ(Υ
ྫ)) (“ Suzhou Apricot ”) is a limited partnership incorporated under the laws of the PRC, with
its general partner being Suzhou Apricot Equity Investment Centre (Limited Partnership) ( ᘽ
ᛆҳ༟ʕː(Υྫ)), which is owned as to approximately 52% and 47% by its
limited partners, Shanghai Zhushou Enterprise Management Centre (Limited Partnership) ( ɪ
ऎጘ˓Άุ၍ଣʕː(Υྫ)) and Shanghai Y ueyi Investment Centre (Limited Partnership)
(ɪऎ˜๐ҳ༟ʕː(Υྫ)), respectively. The general partner of Suzhou Apricot Equity
Investment Centre (Limited Partnership) is Shanghai Apricot Investment Management Co.,
Ltd. (ʮ̡)( “ Apricot Capital ”). Apricot Capital is held as to 46.67%
and ultimately controlled by Liu Wenyi ( ᄎ˖๐), an Independent Third Party, and no other
shareholders of Apricot Capital holds one-third or more of its equity interest. None of the
partners of Suzhou Apricot holds one-third or more of the partnership interests in it.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Apricot Capital focuses on investing in outstanding early-stage and growth-stage
companies in the life sciences industry with a total asset under management of approximately
RMB5 billion as of Latest Practicable Date. The investment portfolio of Apricot Capital in the
biopharmaceuticals and medical and related industries include, among others, Shanghai Junshi
Biosciences Co., Ltd. (ʮ̡) (a company listed on the
Shanghai Stock Exchange (stock code: 688180) and the Hong Kong Stock Exchange (stock
code: 01877)), SinoMab BioScience Limited (a company listed on the Hong Kong Stock
Exchange (stock code: 3681)) and RemeGen Co., Ltd. (Ⴁᖹ(๧̨)ʮ̡)( a
company listed on the Shanghai Stock Exchange (stock code: 688331) and the Hong Kong
Stock Exchange (stock code: 9995)).
Ningbo Hongjia
Ningbo Huiqiao Hongjia V enture Capital Partnership (Limited Partnership) (ි዗̾
͠௴ุҳ༟ΥྫΆุ(Υྫ)) (“ Ningbo Hongjia ”) is a limited partnership established
under the laws of the PRC engaged in investments in medical services, biopharmaceuticals, and
related industries, the investment portfolio of which include, among others, Bloomage
Biotechnology Corporation Limited (ʮ̡) (a company listed on the
Shanghai Stock Exchange, stock code: 688363) and SMO ClinPlus Co., Ltd. ( ౷ጶ౶(ɪऎ)ᔼ
ʮ̡) (a company listed on the Shenzhen Stock Exchange, stock code:
301257). Shanghai Hongjia Private Fund Management Co., Ltd. (ࠢ
ʮ̡), as its general partner, is a private fund manager regulated by the Asset Management
Association of China (ุ՘ึ). Shanghai Hongjia Private Fund Management
Co., Ltd. is ultimately controlled by an Independent Third Party. None of the limited partners
of Ningbo Hongjia holds one-third or more of the partnership interests.
Northern Light V enture Capital
Beta Achieve Limited (“ Beta Achieve ”) is a limited liability company incorporated in
Hong Kong and is ultimately controlled by Feng DENG, an Independent Third Party to the
Company.
Suzhou Jichuang Xinyuan V enture Capital Partnership (Limited Partnership) (ؚ
๕௴ุҳ༟ΥྫΆุ(Υྫ)) (“ Jichuang Xinyuan ”) is a limited partnership incorporated
under the laws of the PRC. The general partner of Jichuang Xinyuan is Suzhou Peiyuan V enture
Capital Partnership (Limited Partnership) ( ᘽψӒ๕௴ุҳ༟ΥྫΆุ(Υྫ)). The de
facto controller of Jichuang Xinyuan is Zhang Pengpeng (؃؃an Independent Third Party
to the Company. None of any partners of Jichuang Xinyuan holds one-third or more of the
partnership interests.
Chongqing Jichuang Fengyuan Private Equity Investment Fund Partnership (Limited
Partnership) (ΥྫΆุ(Υྫ)) (“ Jichuang Fengyuan ”)
is a limited partnership incorporated under the laws of the PRC. The general partner of
Jichuang Fengyuan is Chongqing Jichuang Liyuan Private Equity Investment Fund
Management Partnership (Limited Partnership) (၍ଣΥྫΆ
ุ(Υྫ)). The de facto controller of Jichuang Fengyuan is Zhang Pengpeng (؃؃.)
None of the partners of Jichuang Fengyuan hold 40% or more of the partnership interests.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Beta Achieve, Jichuang Xinyuan and Jichuang Fengyuan are all investment institutions of
Northern Light V enture Capital ( ̏฽Έ௴ҳ), a venture capital dedicated to investing in
early-stage, technology-driven innovative companies, primarily focusing on enterprises in new
technology, healthcare and new consumer industries. The investment portfolio of Northern
Light V enture Capital in the medical and healthcare and related industries include, among
others, Suzhou Zelgen Biopharmaceuticals Co., Ltd. (ʮ̡)( a
company listed on the Shanghai Stock Exchange STAR Market, stock code: 688266),
BrainAurora Medical Technology Limited (a company listed on the Hong Kong Stock
Exchange, stock code: 6681) and Zhejiang Taimei Medical Technology Co., Ltd. (a company
listed on the Hong Kong Stock Exchange, stock code: 2576).
Panlin Capital
Shanghai Panlong V enture Capital Partnership (Limited Partnership) ( ɪऎᇂᗬ௴ุҳ༟
ΥྫΆุ(Υྫ)) (“ Shanghai Panlong ”) is a limited partnership registered under the laws
of the PRC, whose general partner, Shanghai Panlin Management Consulting Co., Ltd. ( ɪऎ
ʮ̡) is a wholly-owned subsidiary of Shanghai Panlin Asset Management
Co., Ltd. (ʮ̡)( “ Shanghai Panlin Asset ”) and ultimately controlled
by Li Y uhui ( ҽρሾ), an Independent Third Party to the Company. Jiaxing Panlin Y uesheng
V enture Capital Partnership (Limited Partnership) (͛௴ุҳ༟ΥྫΆุ(Υ
ྫ)), the single largest partner of Shanghai Panlong, holds 49.00% of the partnership interests
in Shanghai Panlong and its de facto controller is Shanghai Panlin Asset. None of the other
partners of Shanghai Panlong hold one-third or more of the partnership interests.
Qingdao Panlin Hongyu V enture Capital Partnership (Limited Partnership) (ᇂᎌᒿ
༃௴ุҳ༟Άุ(Υྫ)) (“ Qingdao Panlin ”) is a limited partnership registered under the
laws of the PRC, with Shanghai Panlin Asset, its general partner and single largest partner,
holding 48.48% of its partnership interests. Shanghai Panlin Asset is owned as to 46% and
ultimately controlled by Li Y uhui ( ҽρሾ), an Independent Third Party. None of the other
partners of Qingdao Panlin hold one-third or more of the partnership interests.
Hangzhou Panlin Xukang V enture Capital Partnership (Limited Partnership) (ψᇂᎌϛ
ੰ௴ุҳ༟ΥྫΆุ(Υྫ)) (“ Hangzhou Panlin ”) is a limited partnership registered
under the laws of the PRC, whose general partner is Shanghai Panlin Asset, which is owned
as to 46% and ultimately controlled by Li Y uhui ( ҽρሾ), an Independent Third Party. None
of the partners of Hangzhou Panlin hold one-third or more of the partnership interests.
Shanghai Panlong, Qingdao Panlin, and Hangzhou Panlin are investment funds controlled
by Panlin Capital ( ᇂᎌ༟͉) (referring to Shanghai Panlin Asset, its related parties, and the
private equity funds managed by the aforementioned entities), which focuses on two major
fields: Healthcare and Biotechnology field, as well as To B and Technology field. Panlin
Capital mainly invests in early-stage companies, and is dedicated to “Identifying the
entrepreneurs among scientists, and fostering the innovators among entrepreneurs.” The
investment portfolio of Panlin Capital in the healthcare and biotechnology field include, among
others, Shenzhen Kangtai Biological Products Co., Ltd. (ʮ̡)( a
company listed on the Shenzhen Stock Exchange, stock code: 300601) and Guangdong
Hybribio Biotech Co., Ltd. (ʮ̡) (a company listed on the
Shenzhen Stock Exchange, stock code: 300639) and Suzhou Ribo Life Science Co., Ltd. ( ᘽ
ʮ̡).
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Haibang V enture Capital
Shaoxing Haibang Talent V enture Capital Partnership (Limited Partnership) ( ୗጳऎԞɛ
ʑ௴ุҳ༟ΥྫΆุ(Υྫ)) (“ Haibang Talent ”) is a limited partnership established
under the laws of the PRC, with its general partner being Shaoxing Y uecheng Haibang Huirong
Investment Management Co., Ltd. (ʮ̡)( “ Shaoxing
Yuecheng Haibang ”), whose de facto controller is Y ao Naxin (ॶอ), an Independent Third
Party to the Company. Quzhou Haibang Shengrong Investment Partnership (Limited
Partnership) ( ᜪψऎԞ᳅ፄҳ༟ΥྫΆุ(Υྫ)), the single largest partner of Haibang
Talent, holds approximately 66.19% of the partnership interests. Zhejiang Shangyu Investment
Management Co., Ltd. (ʮ̡) is the single largest partner of Quzhou
Haibang Shengrong Investment Partnership (Limited Partnership). The general partner of
Quzhou Haibang Shengrong Investment Partnership (Limited Partnership) is Shaoxing
Y uecheng Haibang. None of the other partners of Haibang Talent holds one-third or more of
the partnership interests.
Shaoxing Haibang Caizhi V enture Capital Partnership (Limited Partnership) ( ୗጳऎԞʑ
౽௴ุҳ༟ΥྫΆุ(Υྫ)) (“ Shaoxing Haibang ”) is a limited partnership registered
under the laws of the PRC, with its general partner being Zhejiang Haibang Investment
Management Co., Ltd. (ʮ̡). Zhejiang Haibang Investment
Management Co., Ltd. is ultimately controlled by an Independent Third Party to the Company,
Y ao Naxin (ॶอ), who holds 55.00% in equity, and is also held by Xie Li as to 45.00%.
Shaoxing Binhai New Area Development Group Co., Ltd. (ʮ̡),
the largest partner of Shaoxing Haibang, holds 40.00% of the partnership interests. None of the
other partners of Shaoxing Haibang holds one-third or more of the partnership interests.
Haibang Talent and Shaoxing Haibang are all investment funds of Haibang V enture
Capital ( ऎԞҳ༟), which primarily focuses on life health, biomedicine, digital economy, new
materials, and high-end manufacturing, with the main investments in early to mid-stage
projects founded by overseas high-level talents. The investment portfolio of Haibang V enture
Capital in the medical and healthcare and related industries include, among others, Zylox-
Tonbridge Medical Technology Co., Ltd. (a company listed on the Hong Kong Stock Exchange,
stock code: 2190), Hangzhou Alltest Biotech Co., Ltd. (ʮ̡)( a
company listed on the Shanghai Stock Exchange, stock code: 688606) and TYK Medicines, Inc
(ʮ̡) (a company listed on the Hong Kong Stock Exchange, stock
code: 2410).
GF Qianhe
GF Qianhe Investment Co., Ltd. (ʮ̡)( “ GF Qianhe ”) is a limited
liability company incorporated under the laws of the PRC. GF Qianhe is wholly owned by GF
Securities Co., Ltd. (ʮ̡), a company listed on the Shenzhen Stock
Exchange (stock code: 000776) and the Hong Kong Stock Exchange (stock code: 1776).
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Huajin Capital
Zhuhai Huajin Lingjian Equity Investment Fund Partnership (Limited Partnership) ( मऎ
ΥྫΆุ(Υྫ)) (“ Huajin Lingjian ”) is a limited partnership
incorporated under the laws of the PRC, with its general partner being Zhuhai Huajin
Lingchuang Fund Management Co., Ltd. (ʮ̡), which is a
wholly-owned subsidiary of Zhuhai Huajin Capital Co., Ltd. (ʮ̡)
(listed on the Shenzhen Stock Exchange, stock code: 000532, “ Huajin Capital ”). The single
largest limited partner of Huajin Lingjian is Zhuhai Huajin Alpha No. 6 Equity Investment
Fund Partnership (Limited Partnership) (ΥྫΆุ(Υ
ྫ)), which holds approximately 99.80% of the partnership interests in Huajin Lingjian. The
general partner of Zhuhai Huajin Alpha No. 6 Equity Investment Fund Partnership (Limited
Partnership) is Zhuhai Huaying Investment Co., Ltd. (ʮ̡). None of the
other partners of Huajin Lingjian hold one-third or more of the partnership interests.
Zhuhai Huajin Lingchuang Fund Management Co., Ltd. is a core private equity
investment fund management company under Huajin Capital. Since its establishment, it has
initiated and established a number of market-oriented equity investment funds and commenced
the business of industrial fund equity investment. It initiated and established medical industry
funds such as Huajin Lingfeng, Huajin Lingshang and Huajin Lingjian. The de facto controller
of Huajin Capital is the State-owned Assets Supervision and Administration Commission of the
Zhuhai Municipal People’s Government. Huajin Capital focuses on investment opportunities in
growing and mature companies through private equity and mergers and acquisitions investment
in strategic emerging industries such as new energy, advanced manufacturing, medical health,
and new generation information technology. The investment portfolio of funds under Huajin
Capital in the medical and healthcare and related industries include, among others, Bivision
Biomedical Technology (Nanjing) Co. Ltd. (Ҧ(ԯ)ʮ̡), and
Guangdong OptoMedic Technologies, Inc. (ʮ̡).
Tailong Investment
Hangzhou Taikun Equity Investment Fund Partnership (Limited Partnership) (ٰ
ΥྫΆุ(Υྫ)) (“ Hangzhou Taikun ”) is a limited partnership incorporated
under the laws of the PRC, engaged in the investments of medical, pharmaceuticals, and related
industries. Hangzhou Taikun has three limited partners, with its largest limited partner,
Hangzhou Tiger Equity Investment Partnership (Limited Partnership) (ᛆҳ༟Υྫ
Άุ(Υྫ)) (“ Tiger Equity ”), holding approximately 49.00% of the equity interests in
Hangzhou Taikun, and no other partners holds one-third or more of the partnership interests in
Hangzhou Taikun. The general partner and fund manager of Hangzhou Taikun is Hangzhou
Tailong V enture Investment Partnership (Limited Partnership) (ψइᘡ௴ุҳ༟ΥྫΆุ(Ϟ
Υྫ)) (“ Hangzhou Tailong ”). The general partner of Hangzhou Tailong is Zhaotai (Zibo)
V enture Capital Management Partnership (Limited Partnership) (इ(଍௹)௴ุҳ༟၍ଣΥྫ
Άุ(Υྫ)), and its general partner is Liu Chunguang (Έ), an Independent Third
Party to the Company, holding approximately 99.00% of the partnership interests. The largest
limited partner of Hangzhou Tailong is also Tiger Equity. Tiger Equity is a wholly-owned
subsidiary of Hangzhou Tigermed Consulting Co., Ltd., a biopharmaceutical company listed on
the Hong Kong Stock Exchange (stock code: 3347) and the Shenzhen Stock Exchange (stock
code: 300347).
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Hangzhou Taikun is an investment fund of Tailong Investment, which is a professional
equity investment management organization focused on the fields of biopharmaceuticals,
medical devices, and big health, with a fund management scale of RMB20 billion. The
investment portfolio of Tailong Investment in the medical and healthcare and related industries
include, among others, Duality Biotherapeutics, Inc., Jiangsu CuroV ax Biotechnology Co., Ltd.
(ʮ̡) and Beijing Luzhu Biotechnology Co., Ltd. (a company listed on
the Hong Kong Stock Exchange, stock code: 2480).
Yihe Fund
Suzhou Suxin Guokang V enture Capital Partnership (Limited Partnership) (਷
ੰ௴ุҳ༟ΥྫΆุ(Υྫ)) (“ Suxin Guokang ”) is a limited partnership incorporated
under the laws of the PRC. The general partner of Suxin Guokang is Suzhou Yihe Private Fund
Management Co., Ltd. (ʮ̡)( “ Yihe Private Fund ”), which is
an indirect wholly-owned subsidiary of Suzhou International Development Group Co., Ltd. ( ᘽ
ʮ̡). Suzhou International Development Group Co., Ltd. is a wholly-
owned subsidiary of the Finance Bureau of Suzhou (҅). The single largest partner
of Suxin Guokang is Suzhou Suxin Qikang V enture Capital Partnership (Limited Partnership)
(઼ੰ௴ุҳ༟ΥྫΆุ(Υྫ)) (“ Suxin Qikang ”), which holds
approximately 52.08% of the partnership interests. None of other partners of Suxin Guokang
holds one-third or more of the partnership interests.
Suzhou Suxin Junnuo V enture Capital Partnership (Limited Partnership) (ёፕ
௴ุҳ༟ΥྫΆุ(Υྫ)) (“ Suxin Junnuo ”) is a limited partnership incorporated under
the laws of the PRC. The general partner of Suxin Junnuo is Yihe Private Fund and is
ultimately controlled by the Finance Bureau of Suzhou. The single largest partner of Suxin
Junnuo is Suxin Qikang, which holds approximately 61.88% of the partnership interests, and
none of other partners of Suxin Junnuo holds one-third or more of the partnership interests.
Suzhou Suxin Qikang V enture Capital Partnership (Limited Partnership) (઼
ੰ௴ุҳ༟ΥྫΆุ(Υྫ)) (“ Suxin Qikang ”) is a limited partnership incorporated under
the laws of the PRC, with its general partner being Yihe Private Fund, and is ultimately
controlled by the Finance Bureau of Suzhou. The single largest limited partner of Suxin Qikang
is Suzhou International Development Group Co., Ltd. (ʮ̡), holding
approximately 43.43% partnership interests in it and is an Independent Third Party. None of the
other partners of Suxin Qikang hold one-third or more of the partnership interests.
Suxin Guokang, Suxin Junnuo and Suxin Qikang are investment funds of Yihe Private
Fund, which focuses on the medical and health sector, investing in new drug research and
development and the import substitution of high-end medical devices, centering on
advancements in bioscience cognition and application technology, the investment portfolio in
the medical and healthcare and related industries of which include, among others, Agibot
Biotechnology (Suzhou) Co., Ltd. (Ҧ(ᘽψ)ʮ̡), Eluminex Biosciences
(Suzhou) Limited (Ҧ(ᘽψ)ʮ̡) and Nanjing Delova Biotech Co., Ltd.
(ʮ̡).
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Lake V entures
Hangzhou Jingxin V enture Capital Partnership (Limited Partnership) (ψᗝː௴ุҳ༟
ΥྫΆุ(Υྫ)) (“ Hangzhou Jingxin ”) is a limited partnership established under the
laws of the PRC. The general partner of Hangzhou Jingxin, Ningbo Zehong Ziyue Investment
Management Co., Ltd. (ʮ̡), is owned as to 70.00% by an
Independent Third Party to the Company, Lyu Xiaoxiang ( ѐወജ). The largest limited partner
of Hangzhou Jingxin is Guizhou Xinbang Pharmaceutical Co., Ltd. (ʮ
̡), a company listed on the Shenzhen Stock Exchange (stock code: 002390), which holds
40.00% of the partnership interests. None of the other partners of Hangzhou Jingxin holds
one-third or more of the partnership interests.
Hangzhou Jingxin has invested in various companies engaged in medical, pharmaceutical
and related industries including, among others, Shanghai Zhimeng Biopharma Co., Ltd. ( ɪऎ
ʮ̡) and Hangzhou Highlight Pharma Co., Ltd. (ʮ̡).
CSPC
CSPC NBP Pharmaceutical Co., Ltd. (ʮ̡)( “ CSPC NBP ”) is
a limited liability company established in China and is principally engaged in the manufacture
and sales of pharmaceutical products. CSPC NBP is a wholly-owned subsidiary of CSPC
Pharmaceutical Group Limited (ʮ̡), a company listed on the Hong Kong Stock
Exchange (stock code: 1093).
Shanjin Capital
Jiaxing Runji Equity Investment Partnership (Limited Partnership) (ᛆҳ༟Υ
ྫΆุ(Υྫ)) (“ Jiaxing Runji ”) is a limited partnership incorporated under the laws of
the PRC and filed as an equity investment fund with the Asset Management Association of
China (ุ՘ึ), with the fund number being: SNB034. Its general partner is
Shanghai Shanjin Private Fund Management Co., Ltd. (ʮ̡)
(“Shanjin Capital ”), which is ultimately controlled and held as to 36.00% equity interests by
Liu Jing ( ᄎẙ), an Independent Third Party to the Company. Jiaxing Runji has more than 30
partners, and none of any of the partners holds one-third or more of the partnership interests.
Qingdao Shanjin Anjia Equity Investment Partnership (Limited Partnership) (τ
ᛆҳ༟ΥྫΆุ(Υྫ)) (“ Shanjin Anjia ”) is a limited partnership incorporated
under the laws of the PRC and is also a venture capital fund filed with the Asset Management
Association of China, with the fund number being: SSA028. Its general partner is Shanjin
Capital (༟͉) and is ultimately controlled by Liu Jing ( ᄎẙ), an Independent Third Party.
Shanjin Anjia has a total of 19 partners, and none of any of the partners holds one-third or more
of the partnership interests.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Shanjin Capital focuses its investment on two major lines: hard technology and medical
health, specializing in investments in areas such as new energy, advanced technology, as well
as research and development of biopharmaceutical, the investment portfolio of which include,
among others, TINA VI Medical Technologies Co., Ltd. (ʮ̡)( a
company listed on the Shanghai Stock Exchange, stock code: 688277) and Suzhou Zelgen
Biopharmaceuticals Co., Ltd. (ʮ̡) (a company listed on the
Shanghai Stock Exchange, stock code: 688266).
Pu’en Guoxin
Shijiazhuang High-Tech Zone Pu’en Guoxin Equity Investment Centre (Limited
Partnership) (ᛆҳ༟ʕː(Υྫ)) (“ Pu’en Guoxin ”) is a limited
partnership and private equity fund incorporated under the laws of China. Guoxin Sichuang
Investment Fund Management (Beijing) Co., Ltd. (၍ଣ(̏ԯ)ʮ̡), the
general partner of Pu’en Guoxin, is ultimately controlled by Wang Hongjie ( ˮ҃௫), an
Independent Third Party to the Company. Pu’en Guoxin has four limited partners, and
Shijiazhuang High-tech Capital Industry Investment Co., LTD (ࠢ
ʮ̡) as its largest limited partner holds approximately 30.00% of the partnership interests.
None of the other partners of Pu’en Guoxin holds one-third or more of the partnership interests.
Shanghai Taiyi
Shanghai Taiyi V enture Capital Partnership (Limited Partnership) ( ɪऎइӥ௴ุҳ༟Υ
ྫΆุ(Υྫ)) (“ Shanghai Taiyi ”) is a limited partnership established under the laws of
the PRC, with Shanghai Taiyou Investment Management Center (Limited Partnership) ( ɪऎइ
Ϟҳ༟၍ଣʕː(Υྫ)) as its general partner, of which general partner is Shanghai Taifu
V enture Capital Management Co., Ltd. (ʮ̡)( “Shanghai Taifu ”).
Shanghai Taifu is ultimately controlled by Liu Junjun (ࠏࠏan Independent Third Party to
the Company. The single largest limited partner of Shanghai Taiyi is Shenzhen Hepalink
Pharmaceutical Group Co., Ltd. (ʮ̡) (a company listed on
the Shenzhen Stock Exchange (stock code: 002399) and the Hong Kong Stock Exchange (stock
code:9989)), holding approximately 49.58% partnership interests and is an Independent Third
Party. None of the other partners of Shanghai Taiyi hold one-third or more of the partnership
interests.
Shanghai Taiyi is an investment fund controlled by Shanghai Taifu, which focuses on
venture capital in the life sciences sector, primarily investing in promising companies in early
and growth stage, the investment portfolio of which include, among others, Shanghai Rendu
Biotechnology Co., Ltd. (ʮ̡) (a company listed on the Shanghai
Stock Exchange, stock code: 688193).
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Shanghai Yuhan
Shanghai Y uhan Equity Investment Fund Partnership (Limited Partnership) (ٰ
ΥྫΆุ(Υྫ)) (“ Shanghai Yuhan ”) is a limited partnership incorporated
under the laws of the PRC, with its general partner being Shanghai Qianlong Y uhan Investment
Management Co., Ltd. (ʮ̡), and is ultimately controlled by
Zhang Hanhong ( ੵဏ҃), an Independent Third Party to the Company. The largest partner of
Shanghai Y uhan is Shenxian Y uzhong Enterprise Management Consulting Center (Limited
Partnership) ( ୸ጤᚑʕΆุ၍ଣፔ༔ʕː(Υྫ)), which holds 36.00% of the partnership
interests in Shanghai Y uhan. The de facto controller of Shenxian Y uzhong Enterprise
Management Consulting Center (Limited Partnership) is Guo Leifeng (ࢤan Independent
Third Party to the Company. None of the other partners of Shanghai Y uhan holds one-third or
more of the partnership interests.
Shanghai Y uhan focuses on investments in the healthcare sector, concentrating on
innovative pharmaceuticals and devices, research and development services and other sectors,
the investment portfolio of which include, among others, Shanghai Xihua Scientific Co., Ltd.
(ʮ̡) and Changchun Zhuoyi Biological Co., Ltd. (ՙሒ
ʮ̡).
Huimei Capital
Huimei Jiankang Haihe (Tianjin) Private Equity L.P . (ئ(ݵ)ږ
ΥྫΆุ(Υྫ)) (“ Huimei Jiankang ”) is a limited partnership incorporated under the
laws of the PRC. The general partner of Huimei Jiankang is Beijing Huimei Private Equity
Fund Management Partnership L.P . (၍ଣΥྫΆุ(Υྫ)( “ Huimei
Capital ”). The general partner and the largest partner of Huimei Capital is Huimei Huakang
Health Management (Beijing) Co., Ltd. ( ౉ӊശੰ਄ੰ၍ଣ(̏ԯ)ʮ̡), holding 60.00%
of the partnership interests in Huimei Capital. Huimei Huakang Health Management (Beijing)
Co., Ltd. is held as to 66.00% equity interests by Luo Rushu ( ᖯν⤳), an Independent Third
Party to the Company. None of the partners holds one-third or more interest in Huimei
Jiankang.
Huimei Jiankang is a private equity fund managed by Huimei Capital ( ౉ӊ༟͉), which
has extensive experiences in medical and healthcare investments. The investment portfolio of
Huimei Capital in the medical and healthcare and related industries include, among others,
Suzhou NanoMicro Technology Co., Ltd. (ʮ̡) (a company listed on
the Shanghai Stock Exchange, stock code: 688690), SMO ClinPlus Co., Ltd. ( ౷ጶ౶(ɪऎ)ᔼ
ʮ̡) (a company listed on the Shenzhen Stock Exchange, stock code:
301257), and PharmaResources (Shanghai) Co., Ltd. (ʮ̡)( a
company listed on the Shenzhen Stock Exchange, stock code: 301230).
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Lake Bleu Capital
LBC Sunshine Healthcare Fund II L.P . (“ LBC Sunshine II ”) is managed by Lake Bleu
Capital (Hong Kong) Limited (“ Lake Bleu Capital ”). LBC Sunshine II is an exempted limited
partnership registered in the Cayman Islands engaged in investing in medical companies in
Asia and Greater China with an investment scope covering pharmaceuticals, biotechnology,
medical devices and healthcare services. An Independent Third Party to the Company, LBC GP
II Limited, is an exempted company incorporated in the Cayman Islands and acts as the general
partner of LBC Sunshine II. LBC GP II Limited is ultimately owned by an Independent Third
Party. None of the partners of LBC Sunshine II hold one-third or more of the partnership
interests.
LBC Sunshine II is an investment fund managed by Lake Bleu Capital ( ૶ϫ༟͉), which
is an investment platform focusing on the healthcare, pharmaceutical, and technology
innovation sectors. The investment portfolio of Lake Bleu Capital in the medical and
healthcare and related industries include, among others, Duality Biotherapeutics, Inc. (a
company listed on the Hong Kong Stock Exchange, stock code: 9606), Akeso, Inc. (a company
listed on the Hong Kong Stock Exchange, stock code: 9926), RemeGen Co., Ltd. (a company
listed on the Hong Kong Stock Exchange, stock code: 9995), Zylox-Tonbridge Medical
Technology Co., Ltd. (a company listed on the Hong Kong Stock Exchange, stock code: 2190),
Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (ʮ̡), Pharmaron
Beijing Co., Ltd.(a company listed on the Shenzhen Stock Exchange (stock code: 300759) and
Hong Kong Stock Exchange (stock code: 3759)) and JD Health International Inc. (a company
listed on the Hong Kong Stock Exchange, stock code: 6618).
Qiaojing Capital
Suzhou Jingtian Medical Investment Partnership (Limited Partnership) ( ᘽψ౻˂ᔼᐕҳ
༟ΥྫΆุ(Υྫ)) (“ Suzhou Jingtian ”) is a limited partnership established in the PRC,
whose general partner is Suzhou Qiaojing Investment Management Consulting Co., Ltd. ( ᘽψ
ʮ̡), which is ultimately controlled and held as to 80.00% equity
interests by Jin Dan (የ), an Independent Third Party to the Company. Suzhou Jingtian has
11 limited partners and none of any of the partners holds one-third or more of the partnership
interests.
Suzhou Jingtian is an investment fund of Qiaojing Capital ( ఐ౻༟͉), which has focused
on investments in medical and consumer industries, including Allgens Medical Science &
Technology Co., Ltd. (ʮ̡) (a company listed on the Shanghai Stock
Exchange; stock code: 688613), Leto Laboratories Co., Ltd. (ʮ̡) and
Xiamen Spacegen Co., Ltd. (ʮ̡).
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Dyee Evergreen
Xiamen Dyee Evergreen V enture Capital Partnership (Limited Partnership) (ڗ
௴ุҳ༟ΥྫΆุ(Υྫ)) (“ Dyee Evergreen ”) is a limited partnership incorporated
under the laws of the PRC and is mainly engaged in private equity investments. Focusing on
modern service industries, Dyee Evergreen mainly invested in medical, healthcare,
biopharmaceutical, information technology and services business, including, among others,
Shanghai Zhimeng Biopharma Co., Ltd. (ʮ̡), Genepoint
Biotechnology (Shanghai) Co., Ltd. (Ҧ(ɪऎ)ʮ̡) and Shanghai Ark
Biopharmaceutical Co., Ltd. (ʮ̡).
The general partner of Dyee Evergreen is Xiamen Derong Investment Partnership
(Limited Partnership) (ᅃᏌҳ༟ΥྫΆุ(Υྫ)), holding 1.00% of the partnership
interests whose general partner is Xiamen Dyee Evergreen Equity Investment Management
Partnership (Limited Partnership) (ᛆҳ༟၍ଣΥྫΆุ(Υྫ)) (“ Dyee
Evergreen Equity ”). Xiamen Zhisheng Investment Management Co., Ltd. (ҳ༟၍ଣ
ʮ̡)( “Xiamen Zhisheng ”) acts as the general partner of Dyee Evergreen Equity and Zhu
Qiuzhen (ࠊ߇an Independent Third Party, held 80.0% equity interest in Xiamen Zhisheng.
Dyee Evergreen had seven limited partners, with the largest limited partner, Xiamen Delihong
Investment Partnership (Limited Partnership) (ҳ༟ΥྫΆุ(Υྫ)) holding
approximately 50.00% partnership interest and each of the remaining limited partners holding
less than one-third of the partnership interest.
Linden Asset
Suqian Lingdao Shengming Changqing Equity Investment Partnership (Limited
Partnership) (ᛆҳ༟ΥྫΆุ(Υྫ)) (“ Suqian Lingdao ”) is a
limited partnership established in China, primarily engaged in equity investment. The general
partner of Suqian Lingdao is Suzhou Lingdao Investment Management Co., Ltd. ( ᘽψჯ༸ҳ
ʮ̡), the de facto controller of which is Sun Y urong (͗ႂ), an Independent
Third Party to the Company. None of any of Suqian Lingdao’s partners holds one-third or more
of the partnership interests. Suqian Lingdao is engaged in investments in the medical
technology and related industries including, among others, AIM V accine Co., Ltd. (ߴޥߕ
ʮ̡) (a company listed on the Hong Kong Stock Exchange, stock code: 6660),
BrioHealth Technologies, Inc. (ʮ̡) and Singlera Genomics Inc.
(ʮ̡).
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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BOCOM International
BOCOM Sci-Tech Innovation Equity Investment Fund (Shanghai) Partnership (Limited
Partnership) (ږ(ɪऎ)ΥྫΆุ(Υྫ)) (“ BOCOM Sci-Tech ”) is a
limited partnership established under the laws of the PRC, with its general partner being
Shanghai Boli Investment Co., Ltd. (ʮ̡). Shanghai Boli Investment Co.,
Ltd. is controlled by BOCOM International Holdings Company Limited, a company listed on
the Hong Kong Stock Exchange (stock code: 3329). None of the partners of BOCOM Sci-Tech
holds one-third or more of the partnership interests.
BOCOM Sci-Tech is principally engaged in equity investment business and have invested
in companies including, among others, Shanghai Xukang Gene Technology Co., Ltd. ( ɪऎҏ
ʮ̡), Hangzhou Sumgen Biotechnology Co., Ltd. (ҦஔϞ
ʮ̡), and Guangdong Raynovent Biotech Co., Ltd. (ʮ̡).
Baidu V entures
BV Fund II L.P . (“ Baidu Ventures ”) is an exempted limited partnership validly
established and legally existing under Cayman law, and is set up as a venture capital institution
by Baidu, Inc. Baidu, Inc. is listed on the Nasdaq Global Market (stock code: BIDU) and the
Hong Kong Stock Exchange (stock code: 9888). The general partner of Baidu V entures is Baidu
V entures GP II, L.P ., which is ultimately controlled by Baidu, Inc., each of which is an
Independent Third Party to the Company. The other partner of Baidu V entures is Fresco Mobile
Limited, holding approximately 99.99% of the partnership interests in Baidu V entures.
Baidu V entures concentrates on early-stage AI-based technology innovation companies
and devoting to several major fields, including but not limited to, technology innovation and
life sciences. The investment portfolio of Baidu V entures and its related parties in the life
sciences related industries include, among others, Beijing DP Technology Co., Ltd. ( ̏ԯଉැ
ʮ̡), BCIFlex Medical Technology Co., Ltd. (ʮ̡) and
Beijing MoleculeMind Technology Co., Ltd. (ʮ̡).
Wenzhou Junzhe
Zhuzhou Wenzhou Junzhe V enture Capital Partnership (Limited Partnership) (̹˖մ
ё䂮௴ุҳ༟ΥྫΆุ(Υྫ)) (“ Wenzhou Junzhe ”) is a limited partnership incorporated
under the laws of the PRC and is managed by its general partner Shanghai Wenzhou Investment
Management Co., Ltd. (ʮ̡), which in turn is ultimately controlled by
Wang Shuguang ( ˮᏣΈ), an Independent Third Party to the Company. None of the limited
partners of Wenzhou Junzhe holds one-third or more of the partnership interests in Wenzhou
Junzhe.
Wenzhou Junzhe focuses on investment in biopharmaceutical-related areas. Its investment
portfolio includes other pharmaceutical companies such as Ab&B Bio-Tech Co., Ltd. JS ( Ϫᘽ
ʮ̡), Zhejiang Zhida Pharmaceutical Co., Ltd. ( एϪ౽༺ᖹุϞ
ʮ̡) and uBriGene Biosciences Co., Ltd. (׼֝(̏ԯ)ʮ̡).
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Jiangmen Qishun
Jiangmen Qishun Technology Partnership (Limited Partnership) (ҦΥྫΆุ
(Υྫ)) (“ Jiangmen Qishun ”) is a limited partnership incorporated under the laws of the
PRC, with its general partner being Li Songsheng (௷), an Independent Third Party to the
Company. The single largest partner of Jiangmen Qishun is Jing Hao (Shenzhen) Equity
Investment Fund Partnership (Limited Partnership) ( ౺ख(ଉέ)ΥྫΆุ(Υ
ྫ)), which holds approximately 99.80% partnership interests in Jiangmen Qishun. The general
partner of Jing Hao (Shenzhen) Equity Investment Fund Partnership (Limited Partnership) is
Qian Hai Wan Hui Equity Investment Fund Management (Shenzhen) Co., Ltd. (ᛆ
ҳ༟၍ଣ(ଉέ)ʮ̡), an Independent Third Party to the Company. None of the other
partners of Jiangmen Qishun hold one-third or more of the partnership interests. Jiangmen
Qishun is engaged in investments in medical companies including Hangzhou Sumgen
Biotechnology Co., Ltd. (ʮ̡).
ABCI
Faithful Way Investment Limited (ʮ̡)( “ Faithful Way Investment ”) is a
limited liability company incorporated in Hong Kong and is wholly-owned by ABCI
Investment Management Limited, which is a wholly-owned subsidiary of Agricultural Bank of
China Limited (a company listed on the Hong Kong Stock Exchange (stock code: 1288) and
the Shanghai Stock Exchange (stock code: 601288)).
Zhineng Capital
Nantong Ruiyi Equity Investment Partnership (Limited Partnership) (ᛆҳ༟
ΥྫΆุ(Υྫ)) (“ Nantong Ruiyi ”) is a limited partnership incorporated under the laws
of the PRC, with the general partner being Nantong Zhineng Private Fund Management Co.,
Ltd. (ʮ̡), which is ultimately controlled and held as to 58.75%
equity interests by Guo Yihong (ߎۯan Independent Third Party to the Company. None of
any of Nantong Ruiyi’s partners holds one-third or more of the partnership interests.
Hangzhou Yantong
Hangzhou Y antong Investment Partnership (Limited Partnership) (ҳ༟ΥྫΆุ
(Υྫ)) (“ Hangzhou Y antong ”) is a limited partnership registered under the laws of the
PRC, with Xie Li ( ᑽɢ), an Independent Third Party to the Company, being its general partner.
Huang Dongdong ( ර̆̆), an Independent Third Party to the Company, serves as the single
largest partner of Hangzhou Y antong and holds 82.96% of the partnership interests. None of the
other partners of Hangzhou Y antong hold one-third or more of the partnership interests.
Hangzhou Y antong is engaged in investments in the biotechnology, medical devices, and
information technology industries. The investment portfolio of Hangzhou Y antong include,
among others, Hangzhou SynRx Therapeutics Co., Ltd. (ʮ̡) and
Zhejiang Curaway Medical Technology Co., Ltd. (ʮ̡).
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Qingding Beijing
Qingding (Beijing) Management Consulting Partnership (Limited Partnership) ( Ꮧཻ(̏
ԯ)၍ଣፔ༔ΥྫΆุ(Υྫ)) (“ Qingding Beijing ”) is a limited partnership established in
accordance with Chinese law and serves as a joint employee investment plan of GF Qianhe. It
is managed by the general partner Mr. He Kuanhua ( Оᄱശ), who is the chairman of GF Qianhe
and an Independent Third Party. None of the partners of Qingding Beijing hold one-third or
more of the partnership interests.
Shanghai Shengcheng
Shanghai Shengcheng Investment Management Partnership (Limited Partnership) ( ɪऎ
໋ϓҳ༟၍ଣΥྫΆุ(Υྫ)) (“ Shanghai Shengcheng ”) is a limited partnership
established under the laws of the PRC. Wu Aimin, an Independent Third Party to the Company,
serves as its general partner, single largest partner, and the de facto controller, holding 58.00%
of partnership interests in Shanghai Shengcheng. None of the other partners of Shanghai
Shengcheng holds one-third or more of the partnership interests. The investment portfolio of
Shanghai Shengcheng in the medical and healthcare and related industries include, among
others, Puzhong Discovery Medical Technology (Shanghai) Co., Ltd. (Ҧ(ɪ
ऎ)ʮ̡) and Shanghai Chengyi Biotechnology Co., Ltd. (ʮ̡).
PUBLIC FLOAT AND FREE FLOAT
Following the conversion of the Unlisted Shares into H Shares and upon completion of
the Global Offering (taking into account the Share Subdivision and assuming that the Offer
Size Adjustment Option and the Over-allotment Option are not exercised):
(a) GenFleet HK, Shanghai Kunjin and Auspicious Delight, each of which is a close
associate of Dr. Lu and Dr. Lan (our Directors and members of the Single Largest
Group of Shareholders), are our core connected persons and a total of 67,560,720
H Shares (taking into account the Share Subdivision) held by them will not be
counted towards the public float, representing 19.56% of our issued share capital in
aggregate;
(b) a total of 32,337,610 Unlisted Shares (taking into account the Share Subdivision)
held by our Shareholders (including Hongyong Bingde, Sinopharm, Huajin Lingjian,
CSPC NBP , Pu’en Guoxin, BOCOM Sci-Tech, Suzhou Jingtian, Wenzhou Junzhe,
Nantong Ruiyi and Shanghai Shengcheng) will not be converted into H Shares and
listed on the Stock Exchange, and therefore will not be counted as part of the public
float, representing 9.36% of our issued share capital in aggregate;
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(c) a total of 167,842,300 Unlisted Shares (taking into account the Share Subdivision)
held by our Shareholders who are not our core connected persons (nor are
accustomed to take instructions from core connected persons of the Company in
relation to the acquisition, disposal, voting or other disposition of their shares, and
their acquisition of shares were not financed directly or indirectly by core connected
persons of the Company) will be converted into H Shares and listed on the Stock
Exchange, and therefore will be counted as part of the public float, representing
48.60% of our issued share capital in aggregate; and
(d) a total of 77,600,000 H Shares (taking into account the Share Subdivision) issued
pursuant to the Global Offering will be counted as part of the public float,
representing 22.47% of our issued share capital in aggregate.
Based on the above, it is expected that immediately following completion of the Global
Offering, a total of 245,442,300 H Shares (taking into account the Share Subdivision),
representing 71.07% of our total share capital upon the completion of the Global Offering
(assuming that the Offer Size Adjustment Option and the Over-allotment Option are not
exercised) will be counted as part of the public float, which is higher than the prescribed
percentage of H Shares required to be held in public hands of approximately 21.30% (on the
basis of the Offer Price of HK$20.39 per H Share) under Rule 19A.13A(1) of the Listing Rules
(assuming that the Offer Size Adjustment Option and the Over-allotment Option are not
exercised). Immediately following the completion of the Global Offering, based on the Offer
Price of HK$20.39 per H Share, assuming that the Offer Size Adjustment Option and the
Over-allotment Option are not exercised, taking into account Offer Shares that may be
subscribed by Cornerstone Investors who will be subject to lock-up requirement pursuant to the
respective Cornerstone Investment Agreements, the expected market value of the H Shares
being held by the public and not subject to any disposal restrictions at the time of Listing under
Rule 19A.13C of the Listing Rules would amount to approximately HK$802.66 million. The
Company is expected to satisfy the free float requirement under Rule 19A.13C(1)(b) of the
Listing Rules.
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CAPITALIZATION OF OUR COMPANY
The table below is a summary of the capitalization of our Company as of the Latest
Practicable Date and the Listing Date:
As of the Latest Practicable
Date without taking
into account the
Share Subdivision
Immediately upon completion of the
Global Offering (taking into account the
Share Subdivision and assuming the
Offer Size Adjustment Option and the
Over-allotment Option are not exercised)
Number of
Unlisted
Shares Held
Approximate
ownership
percentage
Number of
Unlisted
Shares Held
Number of H
Shares Held
Approximate
ownership
percentage
Single Largest Group of Shareholders
– GenFleet HK (Note 1) /H1118/H1118/H1118/H1118/H11184,372,465 16.33% – 43,724,650 12.66%
– Shanghai Kunjin (Note 1) /H1118/H11181,383,607 5.17% – 13,836,070 4.01%
– Auspicious Delight (Note 1) /H1118 1,000,000 3.73% – 10,000,000 2.90%
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,756,072 25.23% – 67,560,720 19.56%
Ourea Biotech /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,241,889 8.37% – 22,418,890 6.49%
Long Star /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,509,115 5.64% – 15,091,150 4.37%
Huagai Capital
– Huagai Xincheng /H1118/H1118/H1118/H1118/H1118/H1118746,755 2.79% – 7,467,550 2.16%
– Capital Health /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118746,755 2.79% – 7,467,550 2.16%
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,493,510 5.58% – 14,935,100 4.32%
Hongyong Bingde (Note 2) /H1118/H1118/H1118/H11181,317,182 4.92% 13,171,820 – 3.81%
Shenzhen Capital
– Shenzhen Hongtu /H1118/H1118/H1118/H1118/H1118/H1118896,012 3.35% – 8,960,120 2.59%
– Shenzhen Capital /H1118/H1118/H1118/H1118/H1118/H1118149,335 0.56% – 1,493,350 0.43%
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,045,347 3.90% – 10,453,470 3.03%
Cherami Sun Tour
– Guangzhou Chenhui /H1118/H1118/H1118/H1118564,325 2.11% – 5,643,250 1.63%
– Chentu No. 14 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118280,017 1.05% – 2,800,170 0.81%
– Chentu No. 15 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118140,021 0.52% – 1,400,210 0.41%
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118984,363 3.68% – 9,843,630 2.85%
Sinopharm (Note 2) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118947,615 3.54% 4,738,075 4,738,075 2.74%
Suzhou Apricot /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118776,199 2.90% – 7,761,990 2.25%
Ningbo Hongjia /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118887,187 3.31% – 8,871,870 2.57%
Northern Light Venture Capital
– Beta Achieve /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118406,919 1.52% – 4,069,190 1.18%
– Jichuang Xinyuan /H1118/H1118/H1118/H1118/H1118/H1118290,557 1.09% – 2,905,570 0.84%
– Jichuang Fengyuan /H1118/H1118/H1118/H1118/H1118116,362 0.43% – 1,163,620 0.34%
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118813,838 3.04% – 8,138,380 2.36%
Panlin Capital
– Shanghai Panlong /H1118/H1118/H1118/H1118/H1118/H1118448,006 1.67% – 4,480,060 1.30%
– Hangzhou Panlin /H1118/H1118/H1118/H1118/H1118/H1118/H1118186,695 0.70% – 1,866,950 0.54%
– Qingdao Panlin /H1118/H1118/H1118/H1118/H1118/H1118/H1118174,394 0.65% – 1,743,940 0.50%
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118809,095 3.02% – 8,090,950 2.34%
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As of the Latest Practicable
Date without taking
into account the
Share Subdivision
Immediately upon completion of the
Global Offering (taking into account the
Share Subdivision and assuming the
Offer Size Adjustment Option and the
Over-allotment Option are not exercised)
Number of
Unlisted
Shares Held
Approximate
ownership
percentage
Number of
Unlisted
Shares Held
Number of H
Shares Held
Approximate
ownership
percentage
Haibang Venture Capital
– Shaoxing Haibang /H1118/H1118/H1118/H1118/H1118348,788 1.30% – 3,487,880 1.01%
– Haibang Talent /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118322,129 1.20% – 3,221,290 0.93%
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118670,917 2.51% – 6,709,170 1.94%
GF Qianhe /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118476,496 1.78% – 4,764,960 1.38%
Huajin Lingjian (Note 2) /H1118/H1118/H1118/H1118/H1118470,271 1.75% 2,351,350 2,351,360 1.36%
Hangzhou Taikun /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118470,271 1.75% – 4,702,710 1.36%
Yihe Fund
– Suxin Guokang /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186,695 0.70% – 1,866,950 0.54%
– Suxin Junnuo /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186,695 0.70% – 1,866,950 0.54%
– Suxin Qikang /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111893,347 0.35% – 933,470 0.27%
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118466,737 1.74% – 4,667,370 1.35%
Hangzhou Jingxin /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118448,006 1.67% – 4,480,060 1.30%
CSPC NBP (Note 2) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118441,176 1.65% 4,411,760 – 1.28%
Shanjin Capital
– Jiaxing Runji /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118232,525 0.87% – 2,325,250 0.67%
– Shanjin Anjia /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186,695 0.70% – 1,866,950 0.54%
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118419,220 1.57% – 4,192,200 1.21%
Pu’en Guoxin (Note 2) /H1118/H1118/H1118/H1118/H1118/H1118395,607 1.48% 3,956,070 – 1.15%
Shanghai Taiyi /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118339,919 1.27% – 3,399,190 0.98%
Shanghai Yuhan /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118331,702 1.24% – 3,317,020 0.96%
Huimei Jiankang /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118307,213 1.14% – 3,072,130 0.89%
LBC Sunshine II /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118294,024 1.10% – 2,940,240 0.85%
Dyee Evergreen /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118280,017 1.05% – 2,800,170 0.81%
Suqian Lingdao /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118192,661 0.72% – 1,926,610 0.56%
BOCOM Sci-Tech (Note 2) /H1118/H1118/H1118/H1118189,048 0.70% 1,890,480 – 0.55%
Suzhou Jingtian (Note 2) /H1118/H1118/H1118/H1118/H1118186,695 0.70% 933,475 933,475 0.54%
Baidu Ventures /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186,695 0.70% – 1,866,950 0.54%
Wenzhou Junzhe (Note 2) /H1118/H1118/H1118/H1118186,695 0.70% 373,390 1,493,560 0.54%
Jiangmen Qishun /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118149,335 0.56% – 1,493,350 0.43%
Faithful Way Investment /H1118/H1118/H1118/H1118118,354 0.44% – 1,183,540 0.34%
Nantong Ruiyi (Note 2) /H1118/H1118/H1118/H1118/H1118/H111893,347 0.35% 466,735 466,735 0.27%
Hangzhou Y antong /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111858,131 0.22% – 581,310 0.17%
Qingding Beijing /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111811,223 0.04% – 112,230 0.03%
Shanghai Shengcheng (Note 2) /H1118 8,891 0.03% 44,455 44,455 0.03%
Investors taking part in the
Global Offering /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – – 77,600,000 22.47%
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111826,774,063 100.00% 32,337,610 313,003,020 100.00%
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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--- page 306 ---
Notes:
(1) Such Shareholders are close associates of Dr. Lu and Dr. Lan (our Directors and members of the Single Largest
Group of Shareholders), and therefore are our core connected persons. Hence, Shares held by such
Shareholders will not be counted towards the public float.
(2) Unlisted Shares held by such Shareholders will not be converted into H Shares and listed on the Stock
Exchange, and therefore will not be counted as part of the public float.
(3) Save as otherwise indicated in Note 1 and Note 2 above, H Shares held by other Shareholders and the H Shares
to be held by Investors taking part in the Global Offering will be counted as part of the public float.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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--- page 307 ---
CORPORATE STRUCTURE IMMEDIATELY BEFORE COMPLETION OF THE GLOBAL OFFERING
The chart below sets out the shareholding structure of our Company immediately before completion of the Global Offering:
16.33%
64.5%
53.69%46.31%
GP
5.17% 8.37% 3.73% 5.64% 5.58% 4.92% 3.90% 3.68% 3.54%
GenFleet
HK(1)
Shanghai
Kunjin(1)
Auspicious
Delight(1)
Ourea
Biotech Long Star Hongyong
Bingde
Huagai
Capital(2)
Shenzhen
Capital(3)
Dr. Lan(1) Dr. Lu(1)
Ningbo
Hongjia
100% 100%
The Company
(PRC)
GenFleet
Zhejiang
(PRC)
GenFleet
Beijing
(PRC)
100%
GenFleet
Shanghai
(PRC)
100%
GenFleet
Australia
(Australia)
100%
GenFleet
U.S.
(United States)
100%
GenFleet
Zhuhai
(PRC)
100%
GenFleet
Hangzhou
(PRC)
Cherami
Sun Tour(4)
3.31%
Sinopharm
3.04%
Northern Light
Venture Capital(5)
3.02%
Panlin
Capital(6)
29.77%
Other Pre-IPO
Investors(7)
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Notes:
1. Shanghai Kunjin and Auspicious Delight are our ESOP Platforms. Dr. Lu, Dr. Lan, GenFleet HK, Shanghai Kunjin and Auspicious Delight are our Single L argest Group of
Shareholders and they have entered into a concert party agreement on March 25, 2022. See “— Concert Party Agreement” above for details.
2. Includes Shares held by Huagai Xincheng and Capital Health. See “— Pre-IPO Investments — Information about our Pre-IPO Investors — Huagai Capital” above for details.
3. Includes Shares held by Shenzhen Hongtu and Shenzhen Capital. See “— Pre-IPO Investments — Information about our Pre-IPO Investors — Shenzhen Capi tal” above for
details.
4. Includes Shares held by Chentu No. 14, Chentu No. 15 and Guangzhou Chenhui. See “— Pre-IPO Investments — Information about our Pre-IPO Investors — Ch erami Sun
Tour” above for details.
5. Includes Shares held by Beta Achieve, Jichuang Xinyuan and Jichuang Fengyuan. See “— Pre-IPO Investments — Information about our Pre-IPO Investor s — Northern Light
V enture Capital” above for details.
6. Includes Shares held by Shanghai Panlong, Qingdao Panlin and Hangzhou Panlin. See “— Pre-IPO Investments — Information about our Pre-IPO Investor s — Panlin Capital”
above for details.
7. Other Pre-IPO Investors include other Shareholders, each holding less than 3% shareholding interests in our Company immediately before completi on of the Global Offering.
See “— Pre-IPO Investments” and “— Capitalization of our Company” above for details.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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--- page 309 ---
CORPORATE STRUCTURE IMMEDIATELY FOLLOWING COMPLETION OF THE GLOBAL OFFERING
The chart below sets out the shareholding structure of our Company immediately following completion of the Global Offering (assuming the
Offer Size Adjustment Option and the Over-allotment Option are not exercised):
12.66%
64.5%
53.69%46.31%
GP
4.01% 6.49%2.90% 4.37% 4.32% 3.03% 2.85% 3.81% 2.74%
GenFleet
HK(1)
Shanghai
Kunjin(1)
Auspicious
Delight(1)
Ourea
Biotech Long Star Huagai
Capital(2)
Hongyong
Bingde
Shenzhen
Capital(3)
Dr. Lan(1) Dr. Lu(1)
Ningbo
Hongjia
The Company
(PRC)
100%
GenFleet
Beijing
(PRC)
100%
GenFleet
Zhejiang
(PRC)
100%
GenFleet
Shanghai
(PRC)
100%
GenFleet
Australia
(Australia)
100%
GenFleet
U.S.
(United States)
100%
GenFleet
Zhuhai
(PRC)
100%
GenFleet
Hangzhou
(PRC)
Cherami
Sun Tour(4) Sinopharm
2.57%
Northern Light
Venture Capital(5)
2.36%
Panlin
Capital(6)
2.34%
Other Pre-IPO
Investors(7)
23.08%
Investors taking
part in the
Global Offering
22.47%
Note: For notes (1) to (7), please see “— Corporate Structure Immediately Before Completion of the Global Offering” above. For the Unlisted Shares and H Shar es held by each
of the Shareholders, please see “— Capitalization of our Company” above.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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--- page 310 ---
OVERVIEW
Who We Are
We are a biopharmaceutical company based in China, featuring a global vision,
international collaborations and operations. We adhere to an innovative development strategy,
with a vision to propel ourselves with the advancement of science and technology to build a
globally competitive biopharmaceutical company.
Upholding the mission of addressing unmet medical needs around the globe, we aspire to
bring new and effective treatment options in the fields of oncology, autoimmune and
inflammatory diseases. During our endeavor, we have established and leveraged a proven,
integrated research and development platform spanning target discovery, molecular discovery
and evaluation, translational science and clinical development, as well as key CMC aspects
including formulation research, process development and quality analysis. Our technological
capabilities include discovery of new molecular entities, novel molecular modalities,
investigation of molecular process routes and quality standards, as well as exploration of
differentiated clinical development strategy and pathway. Combining these internally
accumulated capabilities and external resources of our collaborators and service providers, we
have rendered our pipeline products among the frontrunners in both China and the global
market, resulting in potentially significant market opportunities and commercial value.
Inspired by scientific advancements and driven by our in-depth research and development
capabilities, we had established an evolving product pipeline consisting of eight product
candidates, with five under clinical development, as of the Latest Practicable Date. The
in-house discovered new drug product, GFH925 (fulzerasib, marketed under the brand name
Dupert
®), has been approved for commercialization in China for the treatment of advanced
non-small cell lung cancer (“ NSCLC ”). We view our pipeline programs as competitive,
innovative and market oriented. In total, we possessed 72 issued patents and 118 patent
applications (including 9 PCT applications), of which 12 issued patents and 61 patent
applications (including 2 PCT applications) are related to our Core Products, as of the Latest
Practicable Date, which collectively cover key inventions undergirding our product pipeline.
The following chart summarizes the development status of our pipeline products as of the same
date.
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Compound Target Route of
administration Indication Pre-Clinical IND Phase I Phase II Phase III NDA Key Regulatory
Authority
Expected Upcoming
Milestone
Commercial
Rights Partnership
Oncology: RAS-Focused
GFH925 KRAS G12C Oral
Oral
Oral
Injection
Injection
Injection
Oral
advanced stage
NSCLC
(1st line, combo)(1)
FDA, EMA(2) 2025Q4
Enter Phase III
Global
(outside of
Greater China)
KRAS G12D
advanced stage
PDAC, NSCLC
and CRC(3)
NMPA 2025Q4
Enter Pivotal trials Greater China
GFH276 Pan-Ras advanced stage
Solid tumors / 2025H2
IND Approval Global
GFS784 ADC
(new payload)
advanced stage
Solid tumors / 2026Q1
IND submission Global
Oncology: Others
GFS202A GDF15 / IL-6 Cachexia NMPA 2026H2
Enter Phase II Global
GFH009 CDK9 advanced stage
AML(4) NMPA 2025H2
Enter Pivotal Trial Greater China
GFH018 TGF-βR1
advanced stage
Various solid
tumors
NMPA, Taiwan FDA,
TGA(5) * Global
GFH375
2026H1
Enter Phase II(6)
Immunology
OralGFH312 RIPK1
PBC NMPA Global
NSCLC: non-small cell lung cancer
CRC: colorectal cancer
AML: acute myeloid leukemia
PAD: peripheral artery disease
IC: intermittent claudication PDAC: pancreatic ductal adenocarcinoma
PBC: primary biliary cholangitis
= Core Products
*: Currently assessing the competitive landscape and formulating future clinical development plan.
ADC: antibody drug conjugate
*PAD with PC TGA, FDA(7) Global
BUSINESS
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Notes:
(1) Cetuximab used in the clinical trials of GFH925/cetuximab combination is provided by Merck at no cost, pursuant to the Merck Agreement. For additi onal information, please
see “Business — Major Collaboration and Licensing Arrangements — Merck Agreement.” The Merck Agreement only provided for supply of cetuximab used in the EU clinical
trials. Cetuximab received regulatory approval for the treatment of patients with EGFR- expressing, RAS wild-type metastatic CRC in the U.S. and EU i n 2004. Cetuximab
received regulatory approval for the treatment of patients with squamous cell cancer of the head and neck in the U.S. in 2006 and EU in 2004.
(2) Phase Ib and II clinical trials of the GFH925/cetuximab combination were conducted in the EU. We plan to apply for a Phase III clinical trial of the GF H925/cetuximab
combination in the United States and had a pre-IND meeting with the FDA in February 2025 regarding our planned IND application. We also plan to submit a c linical trial
application for a Phase III clinical trial of the GFH925/cetuximab combination in selected member states within the jurisdiction of the EMA.
(3) We granted V erastem an option to acquire an exclusive license to develop and commercialize GFH375 in territories outside of Greater China within t he specified option exercise
period. In January 2025, V erastem exercised the option to acquire an exclusive license to develop and commercialize GFH375 in territories outside of Greater China.
(4) We granted SELLAS an exclusive (even to ourselves), sublicensable and royalty-bearing right and license to develop, manufacture and commercial ize GFH009 across all
therapeutic and diagnostic uses worldwide outside of Greater China.
(5) The clinical trial of GFH018 was a single trial with a single protocol conducted at different locations.
(6) We have completed a Phase I clinical trial for GFH312 in healthy participants in China. We submitted an IND application for a Phase II clinical trial of GFH312 for the treatment
of PBC to the NMPA in March 2025 and obtained NMPA’s approval in May 2025. We plan to initiate a Phase II clinical trial of GFH312 for the treatment of PBC in the first
half of 2026.
(7) We have completed a Phase I clinical trial for GFH312 in healthy participants in Australia, and we have no plans for subsequent clinical trials in Au stralia. In July 2022, we
submitted an IND application including results of the Phase I clinical trial in Australia to the FDA for a Phase II clinical trial of GFH312 in patients w ith PAD with IC. The
FDA granted our IND application in August 2022, based on the results of the Phase I clinical trial in Australia.
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Our Diverse Pipeline — Comprehensive Innovative Drug Portfolio Addressing RAS
A substantial part of our pipeline programs revolves around therapies targeting RAS
family members, including KRAS, HRAS and NRAS, which are binary switches cycling
between “on” (GTP-bound) and “off” (GDP-bound) states during cellular signaling
transduction to stimulate or silence downstream proteins to effectuate regulation on cell
growth, differentiation and survival. Mutations that result in excessive “on” signal from RAS
thus may lead to uncontrolled cell division and growth and ultimately generation of tumor.
Indeed, RAS genes are among the most frequently mutated oncogenes, and mutations of RAS
family members appear in approximately 30% of all human cancers. RAS-targeting therapies
therefore present a potentially significant market opportunity, according to Frost & Sullivan.
However, selective inhibitors against RAS family members remained elusive for decades
and RAS proteins earned the reputation of being “undruggable.” The seemingly
unsurmountable difficulty was primarily due to the usually smooth shape of RAS proteins, their
high affinity for GTP/GDP and the absence of known allosteric sites for small molecule
binding. A breakthrough in 2013, when a compound was developed that could bind to a small
pocket in the mutant KRAS G12C protein, reinvigorated the field and inspired us to embark
on our journey to pursue RAS-targeting therapies. We anchored the breakthrough of
RAS-targeting therapies and endeavored to develop related targeted therapies.
GFH925 , also known as fulzerasib and marketed in China under the brand name
Dupert
®, is an in-house discovered, small molecule selective inhibitor of the KRAS G12C
protein. It is our lead pipeline product in the RAS-targeting therapies under development.
GFH925 is China’s first and globally the third KRAS G12C selective inhibitor approved for
marketing, having recently obtained the NDA approval from the NMPA as a Class 1 new drug
in August 2024 for second or later-line treatment of advanced NSCLC in China. Clinical results
of GFH925 as a monotherapy for NSCLC have demonstrated potentially favorable safety and
efficacy profile. For instance, in the single arm registrational Phase II clinical trial that
supported the NDA approval, GFH925 was generally well tolerated and demonstrated
encouraging antitumor activity in NSCLC patients harboring the KRAS G12C mutation.
According to its approved label in China, as of the data cut-off date of December 13, 2023, the
confirmed objective response rate (“ ORR”) was 49.1%, and the median progression-free
survival (“ PFS”) was 9.7 months. While no head-to-head clinical trials were conducted, these
values appear to outperform those of the other two FDA-approved selective KRAS G12C
inhibitors (sotorasib and adagrasib) in treating NSCLC, for which the ORR was 37.1% and
42.9% and the median PFS was 6.8 months and 6.5 months, respectively.
We are advancing overseas clinical development of GFH925, including a Phase Ib/II
clinical trial for the first-line treatment of advanced NSCLC as a combination therapy with
cetuximab in countries within the EMA jurisdiction. The FDA also approved our IND
application for a Phase III clinical trial of GFH925 for a later-line treatment of refractory
metastatic colorectal cancer (“ CRC”) as a monotherapy. In China, we oversaw preclinical
studies of GFH925 and obtained IND approval from the NMPA in July 2021. Innovent is the
marketing authorization holder (“ MAH”) of GFH925 in Greater China, pursuant to an
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agreement between Innovent and our Company entered into in September 2021. We are entitled
to an upfront fee, development and regulatory milestone payments, commercial milestone
payment, and royalty payments ranging from a single-digit percentage to a low teen percentage
of GFH925 annual net sales achieved by Innovent, its affiliates and its sublicensees (although
we are not aware of any such sublicensees as of the Latest Practicable Date) upon the
achievement of specific thresholds.
GFH375 is an in-house discovered orally bioavailable, potent and selective small
molecule inhibitor targeting both the “on” GTP-bound and “off” GDP-bound states of KRAS
protein with G12D mutation. According to Frost & Sullivan, GFH375 was among the most
advanced orally bioavailable KRAS G12D inhibitors in the world in terms of development
status as of the Latest Practicable Date. We are conducting a Phase I/II clinical trial of GFH375
in China to evaluate its safety and efficacy in treating advanced solid tumors with the KRAS
G12D mutation. In addition, we have initiated a separate Phase II clinical of GFH375 as a
second-line treatment of PDAC. As of the Latest Practicable Date, the Phase I clinical data
demonstrated good oral bioavailability and anti-tumor activities of GFH375, with potentially
encouraging efficacy in treating multiple tumor types including PDAC and NSCLC.
Leveraging our deep understanding of RAS family members and the experience gained
from developing GFH925 and GFH375 in drug design, molecular mechanism and CMC, we
have gradually broadened our horizon to build a product candidate matrix that not only covers
commonly seen mutant RAS proteins, such as KRAS G12D that similarly features a potentially
significant market potential, but also seeks to dampen excessive activities of RAS proteins in
a pan-RAS manner. These RAS-targeting therapies under development by us not only include
small molecules, such as molecular glue GFH276 , but also functional antibody synergistic
conjugate (“ FAScon ”) GFS784 , a differentiated type of conjugate of an antibody and a small
molecule designed to achieve synergistic effects of both components. The versatility of
modalities that we are exploring to address RAS both shows our commitment to fully address
this challenging target and potentially enables sequential therapies to overcome drug resistance
to mutant-specific treatment options, which we believe would help us maintain a solid footing
in the field, and evidences our research and development capabilities in mastering cutting-edge
technologies. Our RAS-targeting product candidate matrix also renders us one of the
companies with the most comprehensive innovative drug portfolio addressing the RAS proteins
in the world, according to Frost & Sullivan.
Our in-depth research and development capabilities, accumulated know-how and acumen
in the industry also enable us to pursue a diversified pipeline portfolio, which reaches beyond
RAS family members to other therapeutic areas, such as other tumor and adjunctive therapy (a
supplementary form of treatment used in conjunction with traditional therapies) and
autoimmune and inflammatory diseases. For instance, our product candidate GFH312 is an
in-house developed inhibitor of the kinase RIPK1, a key mediator of cell death and
inflammation that potentially allows a broad application in autoimmune, inflammatory and
neurodegenerative diseases. We completed a Phase I clinical trial for GFH312 in healthy
participants in Australia and China, achieving the predefined safety and pharmacokinetic
objectives. GFH312 has also demonstrated differentiation in penetrating the blood-brain barrier
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and its pharmacodynamic profile. After reviewing results from the Australian Phase I clinical
trial, the FDA has allowed us to commence a Phase II clinical trial of GFH312 for peripheral
artery disease (“ PAD”) with intermittent claudication (“ IC”). We are also planning to
investigate GFH312 for the treatment of primary biliary cholangitis (“ PBC”) in China and have
obtained NMPA ’s approval to conduct a Phase II clinical of GFH312 targeting PBC in May
2025. According to Frost & Sullivan, we are globally the first company that not only has
advanced an RIPK1 inhibitor to the Phase II clinical trial-ready stage for the treatment of PAD
with IC but also seeks to explore PBC as a potential indication.
We are also developing GFS202A , a novel bispecific antibody targeting both GDF15 and
IL-6, for the treatment of cachexia, a condition experienced by the majority of patients with
malignant tumors and various other chronic diseases, which significantly affects their
treatment tolerability, quality of life, and poses life-threatening risks. In multiple preclinical
pharmacologic models, once-weekly administration of GFS202A has shown statistically
significant improvement in cachexia. As of the Latest Practicable Date, the Phase I clinical trial
was ongoing, and there was no FDA- or NMPA-approved drug specifically for the treatment
of cachexia. GDF15 has been recently recognized as a key target for treating cachexia, and
reported positive data from clinical study of ponsegromab, a monoclonal antibody directed
against GDF15 developed by Pfizer, underscored its therapeutic potential. We believe that
GFS202A represents a promising treatment of cachexia with the similar mechanism of action
and demonstrates a substantial market potential.
Our Collaborations
To maximize the commercial potential and improve the development efficiency of our
pipeline products, we actively pursue diversified global business development opportunities.
We strategically choose our collaborators to not only allow our strengths to supplement and
reinforce each other to create value, but also ensure that development programs of our pipeline
products will be among the top priorities in our collaborations. In the past, we have entered into
collaborations with Innovent that enabled GFH925 to be smoothly developed and approved for
commercialization in China. We also forged collaborations with SELLAS, which has
significant expertise in hematological malignancies and solid tumors, on GFH009, a small
molecule selective inhibitor of CDK9 designed for the treatment of AML and certain
lymphomas, as well as with V erastem, a company focused on RAS pathway-driven cancers, on
certain of our RAS-targeting pipeline products. As a testament of its confidence in our clinical
development program, we have also secured supplies of cetuximab from Merck for our clinical
trials of GFH925 in combination with cetuximab for the first-line treatment of advanced
NSCLC. We view our track record of forming beneficial collaborations as a critical driver and
validation of our pipeline development.
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Our Management
Our development to date has been guided by an experienced management team comprised
of seasoned industry veterans. Our achievements have been enabled under the leadership of our
co-founders, Dr. Lu and Dr. Lan, both with decades of experience and successful track records
in the pharmaceutical industry, including serving leading roles in Novartis in the United States
and Y angtze River Pharmaceutical in China. Dr. Lu also equipped himself with abundant
experience in start-up companies such as CStone Pharmaceuticals. With leaders who “know the
drill,” we have constantly been steered in the right direction. Other key members of the
management team also synergized their efforts and made indispensable contributions to our
achievements over time. We have built a well-rounded team to effectuate smooth functioning,
consisting of members with in-depth hands-on experience in every key aspect of our business,
spanning early-stage discovery, clinical development, CMC and business development.
Our Path Forward
Building on our established research and development capabilities and the extensive
progress we have made to date, we aim to accelerate the clinical development of our Core
Products, rapidly advance our innovative product pipeline to later stages of development, and
expand our portfolio in other oncology, autoimmune and inflammatory diseases. We also aim
to continue our global strategy through broad and diverse collaborations to maximize the
commercial value of pipelines, internalize certain aspects of drug manufacturing by
establishing GMP-compliant facilities, and expand our professional team to continuously
propel ourselves ahead as a globally competitive biopharmaceutical company.
OUR STRENGTHS
The first approved selective inhibitor of KRAS G12C in China with a favorable safety and
efficacy profile and considerable market potential
Our Core Product GFH925, also known as fulzerasib and marketed in China under the
brand name Dupert
®, is an in-house discovered, small molecule selective inhibitor of the
KRAS G12C protein. Having received the NDA approval from the NMPA as a Class 1 new drug
in August 2024 for the second or later-line treatment of NSCLC harboring the KRAS G12C
mutation, it is China’s first and globally the third approved selective inhibitor of KRAS G12C.
GFH925 was designated as a breakthrough therapy (“ BTD”) for advanced NSCLC and was
conferred the priority review status by the NMPA, and received marketing approval in merely
approximately three years after the NMPA cleared the IND approval in July 2021, underscoring
its recognized competitive advantages over existing therapeutic options. We anticipate that
GFH925 would qualify for negotiation for inclusion in 2026 National Reimbursement Drug
List. GFH925 also received the BTD from the NMPA in May 2023 as a third-line treatment for
advanced CRC harboring the KRAS G12C mutation. With over 15 years of patent term
remaining for GFH925 as of the Latest Practicable Date, we anticipate to realize commercial
returns from GFH925 to fuel our future growth.
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Clinical results of GFH925 as a monotherapy have demonstrated promising safety and
efficacy profile. For instance, in the single arm registrational Phase II clinical trial that
supported the NDA approval, GFH925 was generally well tolerated and demonstrated
encouraging antitumor activity in NSCLC patients harboring the KRAS G12C mutation.
According to its approved label in China, as of the data cut-off date of December 13, 2023, the
confirmed objective response rate (“ ORR”) was 49.1%, and the disease control rate (“ DCR”)
was 90.5% in 116 patients. The median progression-free survival (“ PFS”) was 9.7 months, and
the median overall survival (“ OS”) was 13.3 months. The median duration of response
(“DoR”) was not reached. While no head-to-head clinical trials were conducted, these values
appear to outperform those of the other two FDA-approved selective KRAS G12C inhibitors
(sotorasib and adagrasib) in treating NSCLC, for which the ORR was 37.1% and 42.9% and the
median PFS was 6.8 months and 6.5 months, respectively. GFH925 also demonstrated a
favorable overall safety profile with absence of Grade 3 or above QT interval prolongation or
renal impairment observed in the FDA-approved KRAS G12C inhibitors based on reported
data, which are critical measurements for cardiac safety and drug clearance.
We are advancing overseas clinical development of GFH925 to unleash its therapeutic
potential, including a Phase Ib/II clinical trial for the first-line treatment of advanced NSCLC
as a combination therapy with cetuximab, an antibody drug targeting epidermal growth factor
receptor (“ EGFR ”), in countries within the EMA jurisdiction. As EGFR is situated upstream
of RAS proteins in the signaling pathway and involved in switching on RAS proteins, we
reasoned the combination therapy may achieve synergistic effects in damping the EGFR-RAS
pathway, which is critical for cell growth.
Interim results from the Phase Ib/II clinical trial in Europe provide preliminary evidence
of the synergetic effect of GFH925 and cetuximab, which leads to promising antitumor efficacy
compared to GFH925 as a monotherapy or to the current treatment regimens with
chemotherapy drugs or PD-(L)1 drugs alone or in combination with chemotherapy. Following
completion of the Phase Ib safety confirmation trial and pursuant to the clinical trial protocol,
all data review team members, consisting of principal investigators, the CRO medical monitor
and we as the clinical trial sponsor, collectively reviewed the clinical data from the Phase Ib
trial, and collectively confirmed that the selected dosage of GFH925 is safe, and collectively
agreed that the Phase II trial may proceed. As of the 2024 ASCO Cut-off Date, in a cohort of
33 patients who received the combination therapy and received at least one post-treatment
tumor assessment, the ORR was 81.8% and the DCR was 100%. In addition, the
GFH925/cetuximab combination therapy also led to partial response (“ PR”) in seven out of ten
patients (70.0%) with brain metastasis, demonstrating its promising potential in addressing this
challenging medical condition, considering that brain metastasis is a common and lethal
complication in NSCLC and typically associated with a poor prognosis. The primary endpoints
of the Phase Ib were reached and safety confirmation of Phase Ib trial was completed by the
data review team, as required by the clinical trial protocol. We anticipate completing the Phase
II trial in the fourth quarter of 2025.
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Updated Phase II data of GFH925’s Phase Ib/II clinical trial in Europe was presented at
the 2025 European Lung Cancer Conference (“ ELCC ”) annual meeting. As of January 14,
2025, a total of 47 patients were enrolled and 45 of them received at least one post-treatment
tumor assessment: the ORR reached 80% and the DCR reached 100%. The post-treatment
evaluation revealed 3 patients achieved complete response; 33 others reached partial response,
including one with 100% tumor shrinkage; 57.8% of patients exhibited >50% tumor shrinkage.
As the data cut-off date, the median follow-up time was 12.8 months, and the median
progression-free survival was 12.5 months. 34% of enrolled patients had baseline brain
metastasis, and the ORR was 71.4% per RECIST 1.1 among brain-metastatic patients who
received at least one post-treatment tumor assessment; all non-target lesions of brain-
metastatic patients disappeared or remained stable in the course, and brain target lesions of 5
patients exhibited shrinkage. As of January 14, 2025, the combination therapy presented a
favorable safety/tolerability profile. TRAEs occurred in 87.2% of patients and the majority of
the TRAEs were graded 1-2; 14.9% of patients experienced at least one grade 3 TRAEs; no
grade 4-5 TRAEs. 2 patients had treatment-related serious adverse events (“ TRSAE ”) and the
TRSAEs were assessed to be merely related with cetuximab; 3 patients experienced TRAEs,
unrelated to fulzerasib, leading to dose discontinuation. The KROCUS study demonstrated a
relatively low occurrence of dose discontinuation or reduction among different first-line
G12C-mutant NSLCL combo studies. No new safety signals were identified compared with
fulzerasib or cetuximab as single agent.
We plan to leverage the clinical results in Europe to apply for a Phase III clinical trial in
the United States and Europe to evaluate the safety and efficacy of the GFH925/cetuximab
combination therapy. We had a pre-IND meeting with the FDA in February 2025, where the
FDA provided guidance on the clinical development pathway for fulzerasib in combination
with cetuximab as a first-line treatment for patients with locally advanced or metastatic KRAS
G12C-mutated NSCLC. Subject to the IND approval by the FDA, we subsequently plan to
initiate the Phase III trials in United States in the fourth quarter of 2025. We also intend to
submit a clinical trial application for a Phase III clinical trial of the GFH925/cetuximab
combination in selected member states within the jurisdiction of the EMA in the second half
of 2025.
Beyond NSCLC, we view GFH925 as potentially a valuable therapeutic option in other
challenging cancers, such as advanced CRC. The Phase I results of GFH925X1101 and Phase
Ib results of a Phase Ib/III clinical trial conducted by Innovent in China for GFH925 in
advanced CRC patients revealed an ORR of 45.8% and a DCR of 89.6% for the 600 mg
twice-daily dosing regimen. For the patients who had received at least two lines of prior
treatment, the ORR was 63.0% and the DCR was 88.9% with the same dosing regimen. A
majority of treatment-related adverse events (“ TRAEs ”) were classified as Grade 1 or 2.
Overall, the Phase Ib results demonstrated an encouraging efficacy and safety profile in
advanced CRC patients with KRAS G12C mutation. We plan to investigate the safety and
efficacy of GFH925 monotherapy as a later-line treatment for refractory metastatic CRC
harboring the KRAS G12C mutation in the United States. The FDA approved our IND
application for a Phase III clinical trial in April 2024.
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Both NSCLC and CRC present large addressable markets, and we view GFH925 as
well-positioned to capture the considerable market opportunities. NSCLC is the most common
subtype of lung cancer and represents approximately 85% of all lung cancer cases globally.
According to Frost & Sullivan, the global incidence of NSCLC increased from 1.9 million
cases in 2019 to 2.2 million cases in 2023 and is projected to reach 2.7 million cases by 2032.
The KRAS G12C mutation appears in approximately 13% of the NSCLC incidence, however
there were only five approved KRAS G12C selective inhibitor drugs globally as of the Latest
Practicable Date, including GFH925. The global KRAS G12C inhibitor drug market reached
US$318.9 million in 2023 and is anticipated to reach US$2,748.4 million in 2032, according
to the same source. Given the scarcity of selective inhibitor for KRAS G12C and the
prevalence of the mutation, we anticipate GFH925 to establish a solid footing in the market
soon after its commercial launch. According to Frost & Sullivan, KRAS G12C mutation
appears in approximately 3-4% of the CRC incidence and the global incidence of CRC
increased from 1.8 million cases in 2019 to 2.0 million in 2023, and is expected to reach 2.5
million by 2032, we anticipate GFH925 to generate a significant return for us in its application
to treat advanced CRC.
A diverse set of innovative RAS-targeting product candidates to harness the therapeutic
potential of the RAS pathway
Leveraging our deep understanding of RAS family members and the experience gained
from developing GFH925 in drug design, molecular mechanism and CMC, we have gradually
broadened our horizon to build a diverse set of innovative RAS-targeting product candidates,
which collectively are dubbed our “RAS matrix.” Our RAS matrix not only covers other RAS
mutations, such as KRAS G12D addressed by GFH375, but also includes product candidates
that are designed to dampen excessive activities of RAS proteins in a pan-RAS manner,
including GFH276 and GFS784, which potentially enable sequential therapies to overcome
drug resistance to mutant-specific treatment options. Besides particular targets, the breadth and
diversity of our RAS matrix is reflected in the modalities we have deployed — from small
molecule chemical drug to molecular glue and conjugation of large and small molecules.
Overall, we are at the forefront of harnessing the therapeutic potential of the RAS pathway and
have become one of the companies with the most comprehensive innovative drug portfolio
addressing the RAS proteins in the world, according to Frost & Sullivan.
GFH375, an orally bioavailable small molecule inhibitor of KRAS G12D
KRAS G12D is the most prevalent oncogenic KRAS variant that lacks approved treatment
options. It is found in various cancer types, including approximately 35% of pancreatic
cancers, 12% of CRC and 4% of NSCLC. In 2023, the incidence of pancreatic cancers, CRC
and NSCLC reached 0.5 million, 2.0 million and 2.2 million worldwide, respectively,
according to Frost & Sullivan. Therefore, we believe that the addressable patient population
and market opportunity for drugs targeting KRAS G12D could be substantial.
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However, development of selective KRAS G12D inhibitors has faced significant
challenges. As compared with KRAS G12C protein, the GTPase activity of KRAS G12D
protein is further impaired, which makes the “on” to “off” state conversion proceed in a very
slow rate and thus keeping KRAS G12D predominantly in the “on” state in tumor cells.
Therefore, solely trapping KRAS G12D in its “off,” similar to the action of KRAS G12C
inhibitors on KRAS G12C mutant, state may not be able to achieve sufficient target inhibition
and thus targeting “on” activity is required for a KRAS G12D inhibitor.
We have overcome the technical challenges to discover GFH375, a small molecule
inhibitor that targets KRAS G12D in both “on” and “off” states with a low nanomolar-level
binding affinity, as demonstrated in our preclinical studies. GFH375 has also demonstrated
preclinical antitumor activity in controlling tumor growth in different animal models. As of the
Latest Practicable Date, the Phase I clinical data of GFH375 demonstrated good oral
bioavailability and anti-tumor activities, with potentially encouraging efficacy in treating
multiple tumor types including PDAC and NSCLC. Furthermore, GFH375 differentiates itself
from many other product candidates currently under development for KRAS G12D in terms of
route of administration. Formulated as a once-daily, orally available treatment instead of
requiring infusions, we believe GFH375 can potentially ease repeated drug administration,
improve patient compliance, and therefore potentially increase the overall efficacy of the
treatment regimen.
We are conducting a Phase I/II clinical trial of GFH375 in China to evaluate its safety and
efficacy in treating advanced solid tumors with the KRAS G12D mutation. We received IND
approval from the NMPA in June 2024. We have initiated Phase II part in February 2025.
According to Frost & Sullivan, GFH375 was among the most advanced orally bioavailable
KRAS G12D inhibitors in the world in terms of development status as of the Latest Practicable
Date.
GFH276, a pan-RAS (on) molecular glue
Pan-RAS approaches, which inhibit most oncogenic RAS mutant and wild-type RAS
isoforms, have theoretical advantages over their mutant-specific counterparts. First, pan-
targeting approaches have the potential to block compensatory activation of wild-type RAS
proteins and overcome the acquired resistance to mutant-specific inhibitors. Second, pan-RAS
may also have potentially broad applications and enduring therapeutic benefits in various types
of cancers, such as pancreatic cancer, which feature significant medical needs and substantial
market opportunities. Third, we believe that the pan-RAS approaches may also offer tools
applicable to the development of emerging modalities, including our in-house developed
bioconjugates, FAScon, featuring a combination of antibody and small molecule drug targeting
separate components of the same signaling pathway.
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We believe pan-RAS approaches are differentiated from pan-KRAS approaches that aim
to address multiple KRAS mutations at the same time. As of the Latest Practicable Date, a few
pan-KRAS inhibitors with publicly available information targeted solely the “off” state of
KRAS protein, generally sparing the NRAS and HRAS proteins, according to Frost & Sullivan.
Thus, these pan-KRAS “off” state inhibitors are vulnerable to adaptive resistance caused by
mitogen-activated protein kinase (“ MAPK ”) reactivation via upstream receptor tyrosine kinase
signaling, which drives the resynthesis of KRAS in its “on” state, or through signaling bypass
via wild-type NRAS and HRAS proteins. Moreover, pan-KRAS “off” state inhibitors have been
found ineffective against certain KRAS mutants, such as KRAS G12R or KRAS Q61X, which
exhibit nearly complete impairment of GTPase activity in tumor cells. Therefore, an inhibitor
that targets both multiple KRAS mutants and wild-type RAS variants in their active states,
termed a pan-RAS “on” state inhibitor, would potentially encompass a larger patient population
and yield better clinical outcomes compared to existing pan-KRAS “off” state inhibitors.
GFH276 is our flagship product candidate exploring pan-RAS approaches. It acts as a
molecular glue by forming a binary complex with the chaperone protein cyclophilin A
(“CypA ”), which in turn interacts with RAS in the “on” state, regardless of the particular RAS
variants. Formation of the tricomplex of GFH276, CypA and RAS leads to steric occlusion and
prevents the binding of downstream effector proteins to RAS, therefore disrupting signaling
pathways that drive tumor cell growth.
GFH276 demonstrated potential anti-proliferative activity in tumor cell lines that harbor
various mutations in the RAS family members or in KRAS G12C mutated cell lines with
acquired resistance to sotorasib and adagrasib due to various mechanisms. In addition, the
activity of GFH276 was not affected by the upstream receptor tyrosine kinase (“ RTK”)
activation that results in adaptive resistance to covalent inhibitors of KRAS G12C. While
exhibiting an inhibitory activity in preclinical studies on par with that of RMC-6236, globally
the only Phase III clinical-stage pan-RAS product candidate with a similar mechanism of
action, GFH276 demonstrated potentially enhanced bioavailability, lower efficacious dose and
less distribution in normal tissues compared to RMC-6236. We believe these features suggest
that GFH276 may exhibit a potentially lower efficacious dose and better tolerability in human,
which underscore the competitiveness of GFH276 as a pan-RAS inhibitor and its potential to
benefit the patient population in need. In June 2025, we submitted to the NMPA an IND
application to conduct a Phase I/II clinical of GFH276.
GFS784, a new molecular modality leveraging synergistic effect of large and small
molecules
The biopharmaceutical industry has witnessed notable success with bioconjugates,
exemplified by antibody-drug conjugates (“ ADCs ”), in the treatment of cancers, resulting in
improved treatment outcomes, offering precise delivery of drugs to cancer cells while
minimizing damage to healthy tissues. ADCs are typically designed with an antibody that
functions to recognize diseased cells and a cytotoxic, small molecule payload to kill that
recognized cell.
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We aimed to push the boundary further and explore bioconjugates that realize both precise
targeting and synergistic effects of the large and small molecules. To that end, we are
developing a class of bioconjugates, which we call “FAScon,” featuring a combination of
antibody and small molecule drug targeting separate components of the same signaling
pathway. The design of FAScon also incorporates a highly hydrophilic linker, which is
sufficiently stable to prevent premature release of payload in the blood and enables conjugation
of hydrophobic small molecules at a high drug-to-antibody ratio.
GFS784 is our leading FAScon candidate, consisting of an antibody that blocks EGFR, an
upstream cell surface receptor of RAS signal pathway, and a small molecule pan-RAS inhibitor.
We believe this design has the potential to deliver promising clinical benefits, given the
encouraging results of our clinical development of the GFH925/cetuximab combination, which
also targets EGFR and a RAS variant. GFS784 may even outperform the GFH925/cetuximab
combination, as it addresses RAS not in a mutant-specific manner but with a broader coverage
that is less vulnerable to drug resistance. In our preclinical studies, GFS784 demonstrated
durable antitumor activity measured by tumor volume in mice models regardless of their
sensitivity to Dxd, a commonly deployed cytotoxic payload in ADCs.
Differentiated clinical programs and market potential beyond our RAS matrix
Our research and development efforts extend beyond the RAS family to build a
diversified pipeline portfolio. This is exemplified by GFH312, an in-house developed inhibitor
of the kinase RIPK1, and GFS202A, an in-house developed bispecific antibody targeting
GDF15 and IL-6. GFH312 is designed to address certain autoimmune and inflammatory
diseases, and GFS202A is a potential treatment for cachexia.
GFH312, a small molecule inhibitor of RIPK1
RIPK1 is a master regulator of the cellular decision between pro-survival signaling and
death in response to inflammatory and pro-death stimuli. The unique hydrophobic pocket in the
allosteric regulatory domain of RIPK1 has enabled the development of highly selective small
molecules of its kinase activity. As RIPK1 plays an important role in driving cell death and
inflammation, RIPK1 inhibitors potentially possess broad therapeutic applications for the
treatment of a wide range of human diseases, such as autoimmune diseases, inflammatory
disorders and neurodegenerative conditions. RIPK1 inhibitors thus feature a potentially
significant market opportunity. According to Frost & Sullivan, the global addressable patient
number of the RIPK1 inhibitor drugs reached 313.2 million in 2023 and is anticipated to reach
367.9 million in 2032.
From the outset, we have been developing GFH312 with an innovative development
strategy in mind. In contrast to the majority of other RIPK1-targeting drugs under clinical
development, which are focused on central nervous system disorders, such as amyotrophic
lateral sclerosis, multiple sclerosis, or Alzheimer’s disease, or autoimmune diseases, like
inflammatory bowel disease and psoriasis, we pursue differentiated clinical programs of
GFH312 that target diseases that may seriously affect patients’ quality of life yet lack much
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needed attention. To that end, we aim to be an early-mover to investigate application of RIPK1
inhibitors for the treatment of PAD with IC and PBC. In that regard, GFH312 is the first RIPK1
inhibitor drug candidate developed by a Chinese company that has entered the clinical stage,
and we are among the world’s earliest drug developers that apply a RIPK1 inhibitor to the
treatment of PAD with IC and PBC, according to Frost & Sullivan. For details, see “Industry
Overview — Overview of Ripk1 Drug Market — Competitive Landscape of RIPK1 Drug
Market.”
PAD is a common condition in which atherosclerosis causes narrowed arteries that reduce
blood flow to the arms or legs. Atherosclerosis, the gradual buildup of plaque inside the
arteries, is closely linked to inflammation. PAD is estimated to affect over 300 million people
worldwide, according to Frost & Sullivan. The classic symptom of PAD, IC, is characterized
by exertional leg pain that resolves with rest and is estimated to affect approximately 5.5% of
the newly diagnosed patients with PAD and 12.6% of the patients with a prior diagnosis of
PAD, according to Frost & Sullivan. Patients with PAD with IC have impaired walking ability,
poor functional outcomes, and a reduced quality of life. However, few pharmacological therapy
options are available to address the inflammatory mechanisms of PAD. According to Frost &
Sullivan, the size of the global PAD drug market is anticipated to reach US$13.4 billion in
2032.
PBC is a chronic, slowly progressive autoimmune, cholestatic liver disease. It is
characterized by progressive inflammation and destruction of small bile ducts, resulting in
fibrosis, cirrhosis, and eventually leading to complications of end-stage liver disease and death.
The prevalence of PBC reached 1.2 million globally and 287.3 thousand in China in 2023,
according to Frost & Sullivan. The four approved treatments for PBC as of the Latest
Practicable Date are each with their own limitations. For instance, while ursodeoxycholic acid
(“UDCA ”) is prescribed for patients with PBC as the current first-line therapy, up to 40% of
PBC patients do not achieve a complete response to UDCA as a monotherapy, leaving
considerable unmet medical need for novel treatments of PBC, according to Frost & Sullivan.
We believe GFH312 has therapeutic potential to alleviate the root cause of PAD with IC
and PBC. In both diseases, inflammation plays a critical role in disease progression and/or
manifestation, and GFH312 is demonstrated in our preclinical studies to exhibit not only potent
and selective inhibition of RIPK1 but also an anti-inflammatory effect. For instance, in the
systemic inflammatory response model, mice administered with GFH312 at dosages of 0.1
mg/kg or 1 mg/kg survived while all mice in the control group deceased in 48 hours.
Pharmacodynamic biomarkers of our clinical trial suggest that GFH312 is able to inhibit
RIPK1 activation from doses as low as 5 mg to the highest tested dose of 500 mg, which
potentially enables a wide therapeutic window. In addition, GFH312 has also demonstrated an
ability to penetrate blood-brain barrier, making it suitable for addressing both central nervous
system diseases and peripheral diseases.
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We completed a Phase I clinical trial for GFH312 in healthy participants in Australia and
China, achieving the predefined safety and pharmacokinetic objectives. After reviewing results
from the Australian Phase I clinical trial, the FDA has granted us approval to commence a
Phase II clinical trial of GFH312 for PAD with IC. We are also planning to investigate GFH312
for the treatment of PBC in China and have obtained NMPA ’s approval to conduct a Phase II
clinical of GFH312 targeting PBC in May 2025. According to Frost & Sullivan, we are globally
the first company that not only has advanced an RIPK1 inhibitor to the Phase II clinical
trial-ready stage for the treatment of PAD with IC but also seeks to explore PBC as a potential
indication. We believe our clinical program design potentially paves the way for us to capture
opportunities in those and other blue ocean markets where approved RIPK1 inhibitor drugs are
scarce.
GFS202A, a novel bispecific antibody for cachexia
GFS202A is a novel bispecific antibody targeting both GDF15 and IL-6, two important
cytokines that play crucial roles in inflammatory processes, metabolic regulation, cancer
progression and cachexia. Cachexia is a common, life-threatening wasting condition that can
significantly impact quality of life in affected patients with cancer or other types of chronic
diseases. More than 50% of patients with malignant tumors experience cancer cachexia,
characterized by decreased appetite and accelerated catabolism of muscle and adipose tissue
during tumor progression, resulting in significant weight loss. These debilitating symptoms not
only impact patient tolerability to treatment but also significantly deteriorate their quality of
life, with approximately 30% of cancer related death linked to cancer cachexia, according to
Frost & Sullivan. As of the Latest Practicable Date, there had been no FDA- or NMPA-
approved drug specifically for the treatment of cachexia, according to Frost & Sullivan.
Targeting GDF15 for the treatment of cachexia has been demonstrated as a promising
approach, as reflected in the recently announced Phase II results of ponsegromab, a GDF15
antibody under development by Pfizer, in improving body weight, appetite, physical activity
and muscle mass in cancer patients. As overexpression of GDF15 and IL-6 is associated with
cachexia development and poor survival, we believe a dual neutralization of GDF15 and IL-6
may potentially achieve a better activity compared to targeting GDF15 alone. In multiple
preclinical pharmacologic models, once-weekly administration of GFS202A at doses as low as
1.5-4 mg/kg has shown significant improvement in cachexia with weight loss. GFS202A has
also demonstrated good tolerability profile in preclinical studies.
We have filed IND application with the NMPA in December 2024 and received the IND
approval in March 2025. We initiated Phase I clinical trials for GFS202A monotherapy for the
treatment of cachexia in April 2025. We believe that GFS202A represents a potent treatment
of cachexia and has the potential to capture a substantial market share.
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A powerhouse with a suite of integrated research and development platforms, CMC
expertise and proven business development capabilities
Strong R&D capabilities driven by a suite of integrated technology platforms
Our diversified pipeline portfolio is a natural outcome of our integrated research and
development platforms, spanning target discovery, molecular discovery and evaluation,
translational science and clinical development, augmented by our expertise in key CMC
aspects including formulation research and quality analysis. These research and development
capabilities organically constitute our drug development framework, which enables us to
efficiently advance pipeline programs through different developmental stages.
 Target Discovery Platform is rooted in our endeavor to develop differentiated
therapeutic options based on clinical needs. We focus on addressing clinical needs
by analyzing disease-related factors such as geographical variations, underlying
biological mechanisms, primary or secondary drug resistance, and the specifics of
medical treatment modalities. We also consider the mechanisms of drug action and
the global clinical strategy landscape. We deploy computational biology,
bioinformatics, and artificial intelligence to systematically track, discover and
evaluate new drug targets based on clinical needs. By analyzing literature and
ongoing research in the field, we are able to identify and prioritize novel and
potentially druggable targets. After integrating insights from the developments and
future projections of the industry as a whole, our target discovery platform crafts
differentiated clinical development strategies tailored to specific disease contexts
and therapeutic areas.
 Molecular Discovery and Evaluation Platform is a critical component in our new
drug development process, which is designed to enhance the efficiency and success
rate of our drug discovery efforts. The platform includes integrated molecular
design, synthesis and optimization technology, high-quality molecular discovery,
efficient drug metabolism and pharmacokinetics research technology,
comprehensive biological and drug mechanisms evaluation technology, which
together not only accelerate the molecular investigation phase but also significantly
increase the likelihood of successful drug development.
 Translational Science and Clinical Development Platform encompasses our
biomarker clinical translation technology, precision medicine technology for the
entire project lifecycle, clinical development technology based on data science and
quantitative analysis.
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Our accumulated research and development capabilities, as exemplified by the
establishment, continuous refinement, and application of these technology platforms, have
empowered us to pursue innovative and diversified drug development opportunities. In
addition to the pipeline products described above, our pipeline products include GFH018, an
oral small molecule inhibitor targeting the receptor TGF- /H9252R1, and GFH009, a highly selective
CDK9 inhibitor, both of which have been advanced to the clinical stage.
We also distinguish ourselves through our ability to strategize and execute multicenter
clinical trials across a global scale. We have adopted the strategy to develop many of our
pipeline products by conducting global multicenter clinical trials, which significantly enhances
the efficiency and effectiveness of advancing our product pipeline. We strategically design and
implement clinical plans tailored to the unique needs of each pipeline product based on our
profound understanding of the product targets and indications, as well as our deep knowledge
of clinical and regulatory environments in major jurisdictions worldwide. We are able to
maintain effective communication and collaboration with competent regulatory authorities
across various countries and regions and have successfully conducted clinical trials in the
multiple jurisdictions.
Differentiated CMC expertise to accelerate drug development and facilitate cost control
Since inception, we have strived to build reliable internal CMC capabilities, so that we
are able to continuously optimize the CMC aspects to establish the best practice during product
development. Over the years, we have established integrated CMC capabilities covering key
aspects from the design of synthetic routes for preclinical candidates to process development
and quality control in clinical development and commercial supply of drugs. We have
accumulated in-depth expertise in areas including small molecule process development, dosage
form selection, formulation determination, formulation process development, drug quality
control strategies, development and validation of quality control methodologies, non-GMP
kilogram-scale pilot production, and NDA-stage process validation. Such internal and
differentiated CMC expertise allows us to accelerate the drug development cycle and better
control costs at every stage of drug development.
 Accelerate drug development. Our CMC functions facilitate a smooth drug
development to potentially reduce the overall development timeline. In particular,
we develop suitable process and ensure quality control according to applicable drug
registration regulations at early stages of product development. This strategy
enables us to avoid detours in subsequent development stage resulted from CMC
issues that could have been addressed earlier in the process, therefore may improve
the overall efficiency of our research and development efforts. We believe our
meticulous CMC development for GFH925 since the start of the program facilitated
GFH925 to receive marketing approval in China in merely approximately three
years after it obtained IND approval. Our CMC functions also undergirds our swift
development of the comprehensive RAS matrix in merely seven years since our
inception.
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 Facilitate cost control. Our CMC process development capabilities allow us to
device efficient synthetic routes and establish measures to ensure consistent and
reliable production, thereby contribute to cost control and efficient use of resources.
We are able to significantly lower the manufacturing cost of GFH925 by
approximately 30-fold primarily through optimizing the process route and
production scaling up. Evidencing our reliable capabilities, we will work with
Innovent to secure commercial supply of GFH925 in China. We intend to further
optimize the CMC aspects of GFH925 and view the ability to substantially reduce
the cost of goods, in particular for commercial drug supply, not only as a critical
factor for achieving commercial success, but also as our social responsibility to
lower the burden for patients in need.
Diversified collaboration to maximize value of our pipeline programs
To maximize the commercial potential and improve the development efficiency of our
pipeline products, we actively pursue diversified global business development opportunities.
We strategically choose our collaborators to not only allow our strengths to supplement and
reinforce each other to create value, but also ensure that development programs of our pipeline
products will be among the top priorities in our collaborations. In the past, we have entered into
collaborations with Innovent that enabled GFH925 to be smoothly developed and approved for
commercialization in China, as we recognized the advantages of Innovent to advance clinical
trials, their established commercialization team as well as extensive marketing channel. We
also forged collaborations with SELLAS, which has significant expertise in hematological
malignancies and solid tumors, on GFH009, a small molecule selective inhibitor of CDK9
designed for the treatment of AML and certain lymphomas, as well as with V erastem, a
company focused on RAS pathway-driven cancers, on certain of our RAS-targeting pipeline
products. As a testament of its confidence in our clinical development program, we have also
secured supplies of cetuximab from Merck for our clinical trials of GFH925 in combination
with cetuximab for the first-line treatment of advanced NSCLC. These collaborations are
strategically designed to leverage the strengths of each party, combining our own research and
development capabilities with the extensive commercial and development expertise of such
collaborators. We view our track record of forming beneficial collaborations as a critical driver
of our pipeline development.
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Seasoned Discovery and Development Leadership Team with Successful First-to-Market
Drug Experience
In addition to their complimentary technical skillsets, our founders, Dr. Lu and Dr. Lan,
share the same vision of building a world-class research and development team that is capable
of providing and delivering first-to-market drugs candidates with significant global market
value.
The leadership experiences of our Chairman and co-founder, Dr. Lu, span from
early-stage research and development projects and technology platform building to executing
pipeline strategy, as well as corporate fundraising. Prior to founding our Company, Dr. Lu led
the inception of CStone Pharmaceuticals as the senior vice president for operation and
spearheaded its initial pipeline advancement. Before that, he served as the chief scientific
officer for Y angtze River Pharmaceuticals and Gloria Pharmaceutical, responsible for the
portfolio strategy and execution. Dr. Lu served as a founder of the biology business unit for
WuXi AppTec, part of which later became WuXi Biologics in China. Dr. Lu started his career
as a project team lead at Wyeth Pharmaceuticals, and then moved to Novartis to build up a
novel technical platform for the lead optimization and compound profiling in the United States.
As an experienced chemist and our co-founder and Chief Executive Officer, Dr. Lan is
instrumental in our operation, project execution and organizational buildup. Dr. Lan brings to
us a wealth of cross-border research and development experience spanning a number of large
pharmaceutical companies such as Novartis in the United States and Jiangsu Hengrui
Pharmaceuticals in China. Dr. Lan had a longstanding working relationship with Dr. Lu at
Y angtze River Pharmaceuticals in China, and more importantly, they share a common vision
of building up a globally competitive innovative biotech company in China.
Since our inception, our core team has grown and excelled along with the maturation of
our key pipeline programs. Notably, our Core Product GFH925 (fulzerasib), the first-in-China
KRAS G12C inhibitor, advanced from project initiation to NDA approval in merely six years,
including the time from IND to NDA approval within two and a half years after collaborating
with Innovent. We have integrated our team well within our proprietary development system,
which encompasses all the way from research and development to commercialization. This is
also a reflection of the pursuit of corporate excellence focusing on cross-functional
collaboration and continued process optimization.
We have built a well-rounded discovery and development leadership team consisting of
members with strong technical expertise in every key aspect of the drug development process,
spanning from early-stage discovery to clinical development, and CMC.
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OUR STRATEGIES
Advance our Core Products and leading product candidates through global clinical
development
Leveraging our strong in-house clinical and development capabilities, we aim to continue
to efficiently advance our Core Products through various clinical development programs. We
also plan to maximize the therapeutic value of our assets by expanding the number of
indications and combinations for our product candidates. We anticipate achieving significant
development milestones for our Core Products and other leading product candidates.
 GFH925. We are conducting a Phase Ib/II clinical trial of the GFH925/cetuximab
combination therapy in Europe and anticipate completing that trial in the fourth
quarter of 2025. We plan to leverage clinical results of the European trial to apply
for a Phase III clinical trial in the United States for the same combination therapy.
We had a pre-IND communication with the FDA in February 2025 regarding our
potential IND application for a Phase III clinical trial for the combination therapy.
Once approved, we intend to commence the Phase III trial in the United States in the
fourth quarter of 2025. Furthermore, the FDA also approved our IND application for
a Phase III clinical trial of GFH925 for a later-line treatment for refractory
metastatic CRC harboring the KRAS G12C mutation.
 GFH375. We are conducting a Phase I/II clinical trial of GFH375 in China to
evaluate its safety and efficacy in treating advanced solid tumors with the KRAS
G12D mutation. We received IND approval from the NMPA in June 2024. We
completed the Phase I part of the clinical trial in January 2025 and initiated the
Phase II part in February 2025. In addition, we have initiated a separate Phase II
clinical of GFH375 as a second-line treatment of PDAC.
 GFH312. We have completed a Phase I clinical trial for GFH312 in healthy
participants in Australia and China, respectively. We received the IND approval for
one Phase II clinical trial of GFH312 for the treatment of PAD with IC in the United
States and expect to initiate the Phase II clinical trial to evaluate safety and efficacy
of GFH312 monotherapy in patients with PAD with IC. In addition, we have
submitted the Phase II trial application of GFH312 for the treatment of PBC to the
NMPA in November 2024 and obtained NMPA’s approval in May 2025. We plan to
initiate the clinical trial in the the first half of 2026.
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Advancing and replenishing our other innovative product pipeline with a focus on the
comprehensive RAS pathway product matrix
We strive to achieve and deliver major development milestones for our RAS matrix
pipeline products in the coming years. We believe the anticipated milestones will help us
solidify our position and competitive advantage in the field of RAS-targeting therapies.
As our other RAS matrix product candidates were currently in the preclinical stage as of
the Latest Practicable Date, we intend to advance them to the clinical stage and submit IND
applications once ready.
We will closely monitor the development of market landscape and technology
advancements to formulate or adjust future clinical development plans for other pipeline
products, including GFH009 and GFH018. For additional information, see “— Our Product
Pipeline” and “Future Plans and Use of Proceeds.” We will also explore additional drug
development opportunities that bear significant market potential, particularly in the fields of
oncology, autoimmune disorders and inflammatory diseases, to replenish our product pipeline.
Once our pipeline products approach commercialization in markets where we retain exclusive
commercialization rights, we will determine the commercialization arrangement and, if
warranted, enter into strategic alliances to conduct adequate promotion and achieve smooth
market penetration.
Execute global strategy through broad and diverse collaborations in commercialization
arrangements, business development and pipeline development
To maximize the unique value of our product candidates and fully realize their clinical
potential, we will continue to actively collaborate with both existing and prospective partners
to explore potential opportunities for indication expansion and combination therapies among
our pipeline product candidates and with other potential treatments.
Going forward, we plan to continue and further establish strategic partnerships with
leading international and domestic pharmaceutical companies to expand our geographic
coverage, actively explore the global business layout, and accelerate the global development
of our product candidates, with the ultimate objective to maximize the value of our product
pipeline. We may also explore future collaboration opportunities for the research and
development of some of our product candidates to improve the chance of successful product
development and the efficient usage of our resources.
We plan to adopt multi-level development strategies keyed to the development status of
product candidates. We may seek and establish strategic partnerships with leading international
and domestic pharmaceutical companies to leverage their experience in early-stage drug
discovery, clinical development and manufacturing to expediently advance product
development. As our product candidates move towards later-stage of clinical trial and/or near
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commercialization, we may pursue out-licensing arrangements with large multinational
companies or prestigious local pharmaceutical companies to realize the commercial value of
our product candidates at a potentially earlier stage.
We anticipate our overall business development efforts to revolve around and eventually
lead to gaining favorable brand image and name recognition for our Company, realizing the
global market potential of our products, and maximizing the commercial value of our product
portfolio.
Establish a GMP-compliant formulation manufacturing facility
We have a diverse pipeline of products, including small molecules, functional antibody
synergetic conjugates, as well as molecular glues. As a biopharmaceutical company, we focus
on a comprehensive and balanced development across the value chain of the entire
biopharmaceutical industry. The clinical development and commercialization of our pipeline
products require significant formulation production. To leverage our established CMC
capabilities, including drug product and formulation production, reduce our operational costs
and cover the full cycle of the clinical development process, besides continuing to cooperate
with existing CMOs or CDMOs, we plan to commence the construction of a GMP-compliant
formulation manufacturing facility that meets international standards and would enhance our
manufacturing capabilities especially in preparing the formulations for our pipeline products.
We believe constructing such a facility and strengthening our in-house manufacturing
capabilities would ensure that our products meet the clinical and marketing approval
requirements of regulatory authorities and could further establish our advantages in the
development of challenging products. As of the Latest Practicable Date, we were in the process
of detailing the plan for the facility construction.
Attract, retain and motivate high-caliber talents across our business functions
We are a biopharmaceutical company dedicated to development and commercialization of
drug products. Our employees are key to our growth strategy and ability to develop and
commercialize innovative drugs, and hence we will continue to recruit, train, promote and
retain talents with relevant background and experience in the pharmaceutical and biotech
industries. To fully support our continued growth, we will continue to invest in attracting and
retaining top talents in various aspects of our operations around the world, including discovery,
research and development, manufacture and commercialization. This initiative is a key part of
our strategy to enrich our talent pool. In addition, we will continue to cultivate our culture of
collaboration and efficiency and refine our organizational structure to empower our leaders and
team members to take ownership of their work and reward their contributions. Accordingly, by
investing in the advanced education of our staff, we not only enhance their expertise and skills
but also foster a culture of continuous learning and innovation within our organization. This
approach ensures that our team remains at the forefront of industry knowledge and expertise,
significantly benefiting our research, development, and overall business performance.
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OUR PRODUCT PIPELINE
As of the Latest Practicable Date, we had established a diverse and innovative pipeline
featuring eight pipeline products. A substantial part of our pipeline programs revolves around
therapies targeting RAS family members, which are key regulators during cellular signaling
transduction to stimulate or silence downstream proteins to effectuate regulation on cell
growth, differentiation and survival. In particular, one of our Core Products, GFH925
(fulzerasib, marketed under the brand name Dupert
®), has been approved for
commercialization in China for the treatment of NSCLC. Another Core Product of ours,
GFH375, is one of the most advanced orally bioavailable inhibitors of KRAS G12D in terms
of development status as of the Latest Practicable Date. In addition to RAS, we also explore
treatment options for autoimmune and inflammatory diseases, including our product candidate
GFH312, and other cancer-related therapies. We believe that this diverse range of pipeline
products reflects our commitment to innovation and addressing various medical needs through
advanced therapeutic approaches. The following chart summarizes the development status of
our pipeline product candidates as of the Latest Practicable Date.
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Compound Target Route of
administration Indication Pre-Clinical IND Phase I Phase II Phase III NDA Key Regulatory
Authority
Expected Upcoming
Milestone
Commercial
Rights Partnership
Oncology: RAS-Focused
GFH925 KRAS G12C Oral
Oral
Oral
Injection
Injection
Injection
Oral
advanced stage
NSCLC
(1st line, combo)(1)
FDA, EMA(2) 2025Q4
Enter Phase III
Global
(outside of
Greater China)
KRAS G12D
advanced stage
PDAC, NSCLC
and CRC(3)
NMPA 2025Q4
Enter Pivotal trials Greater China
GFH276 Pan-Ras advanced stage
Solid tumors / 2025H2
IND Approval Global
GFS784 ADC
(new payload)
advanced stage
Solid tumors / 2026Q1
IND submission Global
GFS202A GDF15 / IL-6 Cachexia NMPA 2026H2
Enter Phase II Global
GFH009 CDK9 advanced stage
AML(4) NMPA 2025H2
Enter Pivotal Trial Greater China
GFH018 TGF-βR1
advanced stage
Various solid
tumors
NMPA, Taiwan FDA,
TGA(5) * Global
GFH375
2026H1
Enter Phase II(6)
Immunology
OralGFH312 RIPK1
PBC NMPA Global
NSCLC: non-small cell lung cancer
CRC: colorectal cancer
AML: acute myeloid leukemia
PAD: peripheral artery disease
IC: intermittent claudication PDAC: pancreatic ductal adenocarcinoma
PBC: primary biliary cholangitis
= Core Products
*: Currently assessing the competitive landscape and formulating future clinical development plan.
ADC: antibody drug conjugate
*PAD with PC TGA, FDA(7) Global
Oncology: Others
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Notes:
(1) Cetuximab used in the clinical trials of GFH925/cetuximab combination is provided by Merck at no cost, pursuant to the Merck Agreement. For additi onal information, please
see “Business — Major Collaboration and Licensing Arrangements — Merck Agreement.” The Merck Agreement only provided for supply of cetuximab used in the E.U. clinical
trials. Cetuximab received regulatory approval for the treatment of patients with EGFR- expressing, RAS wild-type metastatic CRC in the U.S. and EU i n 2004. Cetuximab
received regulatory approval for the treatment of patients with squamous cell cancer of the head and neck in the U.S. in 2006 and EU in 2004.
(2) Phase Ib and II clinical trials of the GFH925/cetuximab combination were conducted in the EU. We plan to apply for a Phase III clinical trial of the GF H925/cetuximab
combination in the United States and had a pre-IND meeting with the FDA in February 2025 regarding our planned IND application. We also plan to submit a c linical trial
application for a Phase III clinical trial of the GFH925/cetuximab combination in selected member states within the jurisdiction of the EMA.
(3) We granted V erastem an option to acquire an exclusive license to develop and commercialize GFH375 in territories outside of Greater China within t he specified option exercise
period. In January 2025, V erastem exercised the option to acquire an exclusive license to develop and commercialize GFH375 in territories outside of Greater China.
(4) We granted SELLAS an exclusive (even to ourselves), sublicensable and royalty-bearing right and license to develop, manufacture and commercial ize GFH009 across all
therapeutic and diagnostic uses worldwide outside of Greater China.
(5) The clinical trial of GFH018 was a single trial with a single protocol conducted at different locations.
(6) We have completed a Phase I clinical trial for GFH312 in healthy participants in China. We submitted an IND application for a Phase II clinical trial of GFH312 for the treatment
of PBC to the NMPA in March 2025 and obtained NMPA’s approval in May 2025. We plan to initiate a Phase II clinical trial of GFH312 for the treatment of PBC in the first
half of 2026.
(7) We have completed a Phase I clinical trial for GFH312 in healthy participants in Australia, and we have no plans for subsequent clinical trials in Au stralia. In July 2022, we
submitted an IND application including results of the Phase I clinical trial in Australia to the FDA for a Phase II clinical trial of GFH312 in patients w ith PAD with IC. The
FDA granted our IND application in August 2022, based on the results of the Phase I clinical trial in Australia.
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OUR RAS MATRIX PIPELINE PRODUCTS
Core Product GFH925: A Small Molecule Inhibitor of KRAS G12C
Overview
GFH925, also known as fulzerasib and marketed in China under the brand name Dupert
®,
is an in-house discovered, potent and highly selective small molecule inhibitor of KRAS
protein glycine-to-cysteine mutation at position 12 (“ G12C ”). It demonstrates substantial
activity against KRAS G12C mutant tumors. KRAS is one of the most frequently mutated
oncogenes in human cancers, and G12C is a very common mutation in the KRAS gene,
accounting for 40% of all KRAS mutations in NSCLC according to Frost & Sullivan.
The GFH925 monotherapy received two BTDs for treating advanced KRAS G12C-mutant
NSCLC and CRC patients from the NMPA in January 2023 and May 2023, respectively. In
August 2024, the NMPA approved the NDA for GFH925 for the treatment of NSCLC, making
it the first KRAS inhibitor approved in Mainland China and the third globally. Innovent
commenced the commercial sales of GFH925 in Mainland China shortly after the approval in
the same month. Innovent is the MAH of GFH925 in Greater China, pursuant to an agreement
between Innovent and our Company. For additional information, see “— Licenses, Rights and
Obligations.” We are advancing the clinical development of GFH925 in overseas regions to
unleash its therapeutic potential, including as a combination therapy with cetuximab for the
first-line treatment of advanced NSCLC harboring KRAS G12C mutation, currently in a Phase
Ib/II clinical trial in Europe.
Mechanism of Action
RAS exhibits a guanosine triphosphatase (“ GTPase ”) activity. A GTPase binds to the
nucleotide guanosine triphosphate (“ GTP”) and removes one phosphate group from the GTP
in a process called hydrolysis to generate guanosine diphosphate (“ GDP”). RAS cycles
between “on” (GTP-bound) and “off” (GDP-bound) states during cellular signaling
transduction to stimulate or silence downstream proteins to effectuate regulation on cell
growth, differentiation and survival. Three RAS genes encode for protein isoforms, namely
KRAS, Harvey Ras (“ HRAS ”) and Neuroblastoma Ras (“ NRAS ”). KRAS is one of the most
frequently mutated oncogenes in human cancers. KRAS mutations are detected in nearly 90%
of pancreatic cancer, 30-40% of colon cancer, and 15-20% of lung cancer patients according
to Frost & Sullivan. These mutations are often associated with resistance to targeted therapies
and poor outcomes in cancer patients. G12C is one of the most common mutations in KRAS
gene, accounting for approximately 15% of all KRAS mutations, and it is also the most
prevalent variant of KRAS mutations in NSCLC according to Frost & Sullivan. The KRAS
G12C variant leads to enhanced proliferation and survival of tumor cells.
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GFH925 is a small molecule that exhibits a highly selective inhibitory effect on the KRAS
G12C mutation site, through covalent, irreversible modification of cysteine residues in the
KRAS G12C protein. Different from reversible inhibitors, GFH925 functions by forming a
chemical bond with the mutated cysteine residue, which cannot be broken apart in the cell once
formed. In this manner, GFH925 impedes the GTP/GDP exchange, an essential step in pathway
activation, and disrupts the mutant KRAS protein from interacting with downstream proteins.
By down-regulating the activation level of the KRAS protein, GFH925 results in subsequent
down-regulation of the downstream signaling pathways, effectively inducing apoptosis in
tumor cells and arresting the cell cycle, leading to an efficient antitumor effect.
The diagram below illustrates the mechanism of action of GFH925:
Cell survival, proliferation and differentiation
KRAS
G12C
GTP
MEK
RAF
ERK
KRAS
G12C
GDP
AKT
PI3K
mTOR
RAL
RALGDS
RLBP1
SOS1
SHP2
GEF
GAP
RTKs
GF
GFH925
1. In normal cells, wild type KRAS cycles between active and
inactive states, serves as a molecular switch to transmit
upstream signaling to downstream pathways and thus
regulates cell survival, proliferation and differentiation.
2. KRAS G12C mutation impairs GAP - mediated GTP hydrolysis
process, hyperactivates downstream pathway, leads to
uncontrolled cell proliferation and ultimately promotes
tumorigenesis.
3. GFH925 traps KRAS G12C in its inactive state via covalent
modification, blocks  downstream pathway signaling and
inhibits tumor growth.
Source: Company information
Abbreviations: ERK: extracellular signal-regulated kinase; GAP: GTPase-Activating Protein; GER: Guanine
Exchange Factor; GF: growth factor; MEK: MAPK/ERK; mTOR: mechanistic target of rapamycin; PI3K:
phosphoinositide 3-kinases; RAF: rapidly accelerated fibrosarcoma; RALGDS: Ral guanine nucleotide dissociation
stimulator; RLBP1: retinaldehyde-binding protein 1; RTK: receptor tyrosine kinase; SHP2: Src homology 2
domain-containing phosphatase 2; SOS1: son of sevenless 1
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Market Opportunity and Competition 1
RAS drug market is increasingly competitive with major players such as Mirati (acquired
by Bristol Myers Squibb (NYSE: BMY) in 2024) and Revolution Medicines
(NASDAQ:RVMD) actively expanding their RAS matrix. One of the most common mutations
in the KRAS gene is G12C, accounting for approximately 15% of all KRAS mutations, and it
is also the most prevalent variant of KRAS mutations in NSCLC. The KRAS G12C mutation
occurs in approximately 13% of NSCLC, in 3% to 4% of CRC, and other solid tumors.
GFH925 (fulzerasib) was the first KRAS G12C inhibitor drug that received approval for
commercialization in China. Globally, there were four other KRAS G12C inhibitor (adagrasib,
sotorasib, garsorasib and glecirasib) drugs that have been approved as of the Latest Practicable
Date. Among them, garsorasib, glecirasib and fulzerasib received received approval for
commercialization in China as of the same date. As of Latest Practicable Date, there were more
than 20 KRAS G12C inhibitor candidates being clinically developed globally.
With the continuous market penetration of the commercialized KRAS G12C inhibitor
drugs and development of new drugs, the global KRAS G12C inhibitor drug market is expected
to grow rapidly from US$489.1 million in 2024 to US$3,490.7 million in 2033 with a CAGR
of 24.4%. The diagram below sets forth the historical and projected global market size of
KRAS G12C inhibitor drugs from 2021 to 2033.
Global KRAS G12C Inhibitor Drug Market, 2021-2033E
13.1 126.7 161.7 213.0 282.7 356.7 436.1 504.0 574.6 647.1
90.0 285.0 318.9 476.0
665.0 889.4
1,114.6
1,408.0
1,741.6
2,071.7
2,346.5
2,595.6
2,843.6
90.0
285.0 318.9
489.1
791.7
1,051.1
1,327.6
1,690.7
2,098.3
2,507.7
2,850.5
3,170.2
3,490.7
2021 2022 2023 2024 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E
Greater China ROW
CAGR Greater China Global
2021-2024 - 75.8%
2024-2033E 54.2% 24.4%
Million USD
Source: Frost & Sullivan Analysis
Note
1. Market information and statistics set out in this subsection have been extracted from an report prepared by
Frost & Sullivan.
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We are advancing overseas clinical development of GFH925 to unleash its therapeutic
potential, including a Phase Ib/II clinical trial for the first-line treatment of advanced NSCLC
as a combination therapy with cetuximab and as a later-line treatment of refractory metastatic
CRC as a monotherapy.
Among the common driver genes identified in NSCLC, KRAS mutations are one of the
most prevalent mutations, accounting for approximately 20% of cases, and KRAS G12C
mutation alone is present in approximately 13% of all NSCLC cases. The global incidence of
NSCLC increased from 1,937.6 thousand in 2019 to 2,203.5 thousand in 2024, and is expected
to further increase to 2,743.2 thousand in 2032. In China, the incidence of NSCLC increased
from 830.2 thousand in 2019 to 946.7 thousand in 2024, and is expected to further increase to
1,119.3 thousand in 2033. The 5-year survival rate for lung cancer in China is comparable to
that in the United States, both standing at approximately 20%, which is significantly lower than
that of other major cancers. The low survival rate and deficient treatment underscore the
critical need for improved therapeutic options. With the existing treatment regimen, many
patients experience rapid disease progression and unsatisfied outcomes, and there is a lack of
targeted therapies for KRAS mutations in NSCLC. GFH925 (fulzerasib) became the first
commercially available KRAS G12C inhibitor drug in China, which offers novel solution for
patients with KRAS G12C mutations, and potentially addresses the gap in targeted therapies
for this mutation. However, GFH925, as a KRAS G12C inhibitor, is not designed or expected
to eliminate drug resistance or certain side effects, such as gastrointestinal toxicity, associated
with other approved KRAS G12C inhibitor drugs. See “Industry Overview — Overview of
KRAS G12C Drugs — The impact on the market potential and acceptance of GFH925” for
comparison of GFH925 with other approved KRAS G12C inhibitor drugs.
RAS is one of the most frequently mutated oncogenes in CRC, and KRAS G12C mutation
alone appears in approximately 3-4% of the CRC incidence. The global incidence of CRC
increased from 1,849.1 thousand in 2019 to 2,005.2 thousand in 2024, and is expected to
further increase to 2,472.6 thousand in 2033. In China, the incidence of CRC increased from
477.1 thousand in 2019 to 542.4 thousand in 2024, and is expected to further increase to 642.0
thousand in 2033. CRC ranks as the second most lethal and the third most commonly-
diagnosed cancer globally. The incidence of CRC among the younger population has also been
rising. We view GFH925 as potentially a valuable therapeutic option in advanced CRC.
Advantages of GFH925
GFH925 (fulzerasib) is the first approved KRAS G12C inhibitor for the treatment of
NSCLC in China. We believe that GFH925 has the following advantages:
Highly selective inhibition of the KRAS G12C protein mutant
In preclinical studies evaluating the binding of GFH925 to human KRAS recombinant
proteins, selective covalent modification of GFH925 to the cysteine site at position 12 on the
KRAS G12C protein was observed. Notably, no covalent modification was detected on cysteine
sites other than G12C in KRAS G12C or for any cysteines on the KRAS wild-type proteins.
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Furthermore, GFH925 dose-dependently inhibited nucleotide exchange in human KRAS G12C
recombinant proteins, with a half-inhibitory concentration (“ IC50”) of 29 ± 3 nM. Importantly,
GFH925 did not exhibit inhibitory activity against KRAS wild-type protein. We believe that
GFH925 selectively targets the KRAS G12C mutant protein with high potency in such
preclinical studies.
Favorable safety profile
GFH925 has demonstrated favorable safety profiles in clinical trials. For instance, in the
clinical trial in China that supported the NDA approval of GFH925, there were no Grade 3 or
above QT interval prolongation or renal impairment observed in the FDA-approved KRAS
G12C inhibitors, which are critical measurements for cardiac safety and drug clearance. There
was also lower incidence of treatment-related adverse events than those of another FDA-
approved KRAS G12C inhibitor based on reported data, although no head-to-head comparisons
were conducted in the clinical trial.
In preclinical studies using Sprague-Dawley rat and Beagle dog models, GFH925 also
demonstrated a favorable safety profile. In particular, GFH925 had no impact on the central
nervous system or the respiratory system of Sprague-Dawley rats. It also had no impact on
cardiovascular parameters or affect electrocardiographic parameters in a 28-day repeated dose
toxicity test in Beagle dogs.
V alidated antitumor effect
GFH925 has also demonstrated the antitumor effect in NSCLC patients harboring the
KRAS G12C mutation. For instance, in the single arm registrational Phase II clinical trial that
supported the NDA approval, the confirmed ORR was 49.1%, and the DCR was 90.5% in 116
patients as of the data cut-off date of December 13, 2023. As of the same date, the median PFS
was 9.7 months, and the median OS was 13.3 months. The median DoR was not reached. While
no head-to-head trials were conducted, these values appear to outperform those of the other two
FDA-approved selective KRAS G12C inhibitors (sotorasib and adagrasib) in treating NSCLC,
for which the ORR was 37.1% and 42.9% and the median PFS was 6.8 months and 6.5 months,
respectively.
In preclinical mouse xenograft tumor models, GFH925 demonstrated clear activities in
controlling tumor growth as measured by the size of tumor. In preclinical studies, the tumor
inhibitory effects of GFH925 were similar to or better than those of an FDA-approved KRAS
G12C inhibitor.
Potential for combination therapy to realize better clinical outcomes
While RAS is a critical component in its associated cellular signaling pathways, there are
other potentially druggable targets in those pathways that, once addressed in combination with
RAS, may lead to better inhibitory effect of the pathways and result in potentially more
favorable clinical outcomes. For instance, in an ongoing Phase Ib/II trial that we are conducting
in Europe to evaluate the safety and efficacy of the GFH925/cetuximab combination therapy
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as a first line treatment for advanced NSCLC harboring KRAS G12C mutation, the ORR was
81.8% and the DCR was 100% in a cohort of 33 patients as of the 2024 ASCO Cut-off Date.
In addition, the combination therapy also exhibited a favorable safety profile, further
suggesting its potential as a competitive and potentially advantageous treatment option. These
results provide preliminary evidence of the synergetic effect of GFH925 and cetuximab, which
leads to promising antitumor efficacy compared to GFH925 as a monotherapy or to the current
treatment regimens with PD-(L)1 drugs alone or in combination with chemotherapy. According
to Frost & Sullivan, the combination therapy of GFH925 and cetuximab for the treatment of
NSCLC that we are investigating is among the first of its kind to co-target KRAS G12C and
EGFR in terms of the clinical development status.
Summary of Clinical Trials
We retain all rights of GFH925 in jurisdictions outside of Greater China, and we were
conducting clinical development of GFH925 in combination with cetuximab in Europe, as of
the Latest Practicable Date. In Greater China, we have exclusively out-licensed the
development, manufacturing and commercialization rights of GFH925 to Innovent. Innovent is
the MAH of GFH925 in Greater China. However, Innovent does not have any role or
involvement in the clinical trials of GFH925 in EU and the U.S. For additional information, see
“— Licenses, Rights and Obligations.” The following table sets forth an overview of the
ongoing clinical trial of GFH925 that we are conducting, as well as the completed clinical trial
of GFH925 in China that supported the NDA approval:
Study Number Phase Study Design Sites Subjects Status
Actual Patient
Enrollment
GFH925X0201
(sponsored
by us) /H1118/H1118/H1118/H1118
Ib/II Evaluate safety,
tolerance and
PK and
efficacy of
GFH925 in
combination
with
cetuximab
Sites within the
jurisdiction
of EMA
(Greece,
Italy, Spain)
Patients with
advanced
NSCLC
harboring
KRAS G12C
mutation
Phase II trial is
ongoing
1
Six in the Phase
Ib trial, 41
in the Phase
II trial as of
April 25,
2024
2
GFH925X1101
(initiated by
us and
subsequently
sponsored by
Innovent) /H1118/H1118
I/II Evaluate the
safety,
tolerability
and efficacy,
and PK of
GFH925
Mainland China Patients with
advanced
solid tumors
with KRAS
G12C
mutation
Completed No less than
293 (based
on the
label of
fulzerasib)
Note:
(1) The data review team reviewed the Phase Ib data, confirmed safety of the selected dose and allowed
Phase II to proceed in October 2023, in accordance with the approved clinical trial protocol.
(2) For the purpose of 2024 American Society of Clinical Oncology (“ ASCO ”) abstract, six patients were
enrolled in the Phase Ib trial and 40 patients were enrolled in the Phase II trial as of April 19, 2024, the
2024 ASCO Cut-off Date.
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The following sets forth an overview of the key clinical trials of GFH925:
GFH925X0201 (KROCUS): A Phase Ib/II trial to evaluate the safety, tolerability, PK, and
efficacy of GFH925 in combination with cetuximab in patients with previously untreated
advanced NSCLC harboring KRAS G12C mutation sponsored by us
This trial is a multi-center, open-label Phase Ib/II clinical trial. The trial consists of two
parts: the Phase Ib part and the Phase II part. The two parts are separate clinical trials with
different designs, objectives and endpoints, while the designs and the mechanism on how to
proceed to the Phase II part (after the safety of the combination of GFH925 and cetuximab is
confirmed by the Phase Ib part) are included in the same clinical trial protocol, which is
approved by relevant health authorities in countries within the jurisdiction of the EMA.
The Phase Ib part is a safety confirmation trial to evaluate the safety and tolerability of
GFH925 at certain dosage level combining with cetuximab. The safety data generated in the
Phase Ib part shall be reviewed by a data review team, consisting of principal investigators,
CRO medical monitor and we as the clinical trial sponsor, to confirm safety before the Phase
II part is commenced. Once safety of the combination in the Phase Ib is confirmed, the
enrollment of Phase II will be initiated.
Phase Ib Trial
Trial Design. In the Phase Ib trial, six patients were enrolled to receive a combination
treatment of GFH925 and cetuximab to confirm safety. Cetuximab is administrated at a dose
of 500 mg/m
2 once every two weeks, as recommended by its FDA-approved prescribing
information. GFH925 was administered at a dose of 600 mg, twice daily (“ BID”), which has
been established as the recommended Phase II dose (“ RP2D ”) of GFH925 monotherapy based
on the first-in-human GFH925X1101 clinical trial. The treatment cycle is defined as 28 days.
The safety data generated in the first cycle are designed to be reviewed by the data review
team. According to the clinical trial protocol of the KROCUS Study approved by the relevant
health authorities of the MSCs, this Phase Ib trial, is a standalone complete trial equivalent to
a typical Phase I clinical trial regulated by the Competent Authority.
While results of a previous clinical trial as a single agent facilitated our initial dose
selection of GFH925 for the combination therapy, the clinical trial protocol provides that the
dose level of GFH925 shall be adjusted lower should the safety results of this Phase Ib trial
suggests. In particular, should the safety of GFH925 at the dose level of 600 mg BID not be
confirmed, one or more dose levels of GFH925 lower than 600 mg BID may be explored in the
combination therapy, prior to the commencement of the Phase II trial. Therefore, we view this
Phase Ib trial, as a safety confirmation trial, also serving a dose finding/confirmation purpose.
The primary objective of Phase Ib trial is to evaluate the safety and tolerability of
GFH925 in combination with cetuximab in patients with advanced KRAS G12C mutant
NSCLC. The secondary objectives of Phase Ib trial are to evaluate PK and preliminary efficacy
of GFH925 in combination with cetuximab.
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The primary endpoints of Phase Ib trial are to evaluate incidence of adverse events
(“AEs”), serious adverse events (“ SAEs ”), and changes in laboratory parameters, vital signs,
physical examinations, and electrocardiogram. The secondary endpoints of Phase Ib trial are to
evaluate plasma concentration and PK parameters of GFH925, and best overall response
(“BOR”), duration of response (“ DoR”), time to response (“ TTR”), progression free survival
(“PFS”), and overall survival (“ OS”).
The key inclusion criteria for the trial include but not limited to: (i) male or female
patients aged 18 years or older; (ii) patients with a life expectancy greater than three months
judged by the investigator; (iii) patients with histologically or cytologically confirmed
advanced KRAS G12C-mutated NSCLC; (iv) patients with sufficient organ functions; and
(v) patients whose toxicities from prior antitumor therapy have resolved to baseline levels or
Common Terminology Criteria for Adverse Events Grade 1 (with neurotoxicity or alopecia not
greater than Grade 2). The key exclusion criteria for the trial include but not limited to:
(i) patients with clinically significant cardiovascular diseases; (ii) patients with active central
nervous system metastases and/or carcinomatous meningitis; (iii) patients with clinically
significant gastrointestinal diseases; (iv) patients with uncontrolled systemic diseases; or
(v) patients that have undergone major surgery within four weeks prior to the initiation of the
treatment.
Scope of IND Approval. The KROCUS stud y — a Phase Ib/II trial of GFH925 in
combination with cetuximab for patients with previously untreated advanced NSCLC
harboring the KRAS G12C mutation in Italy, Spain, and Greece — was approved by the
respective regulatory authorities in February 2023 (Italy), February 2023 (Spain), and June
2023 (Greece). Under the approved trial protocol, the combination therapy was intended to be
evaluated as a first-line treatment. However, the Competent Authorities did not require, and the
protocol did not include, a head-to-head comparison in this Phase Ib/II study. We intend to
conduct such a head-to-head study in the planned pivotal trial.
Trial Status. The Phase Ib trial was initiated in April 2023. The first patient was dosed in
April 2023. All six enrolled patients completed one 28-day treatment cycle in September 2023,
and all six patients were safety-evaluable. In October 2023, the primary endpoints of the Phase
Ib were reached and safety confirmation of Phase Ib trial was completed by the data review
team, as required by the clinical trial protocol.
The following summary outlines the safety data reviewed by the data review team as
stipulated in the clinical trial protocol.
Safety Data. In the first treatment cycle, one patient experienced Grade 3 asthenia related
to both of GFH925 and cetuximab, meeting the criteria of predetermined toxicity listed in the
clinical trial protocol. No other predetermined toxicity occurred. As of the data cut-off date
October 10, 2023, no fatal treatment-emergent adverse events or treatment-related serious
adverse events occurred. Four patients (66.7%) experienced at least one treatment-related
adverse events, and most of the adverse events were Grade 1 or Grade 2. There were one
reported Grade 3 asthenia and one Grade 3 rash related to both GFH925 and cetuximab. A
Grade 3 skin fissures was not assessed as related to GFH925. Other than those Grade 3
treatment-related adverse events, no other Grade 3 or more severe treatment-related adverse
events were reported. There were no unexpected safety signals from the Phase Ib trial. Overall,
the results demonstrate a favorable safety profile of the combination therapy.
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No Objection to the Commencement of Phase II Trial
Pursuant to the clinical trial protocol approved by the relevant health authorities within
the jurisdiction of the EMA, in October 2023, the data review team, consisting of a
majority-independent parties, including five principal investigators, one representative of the
CRO medical monitor and two representatives from us as the medical and biostatistical
representative, reviewed the results of the Phase Ib trial, confirmed the safety of the selected
dose of the combination therapy, and agreed that the Phase II trial may proceed. All data review
team members are required to vote. If the decision isn’t unanimous, it will be determined by
majority vote, with the leading principal investigator casting two votes to break a tie when
there’s an even number of members. We believe the data review team is competent with
relevant experience to conclude on the completion of a clinical trial under the EMA regulatory
framework. Authorities of similar data review team or data monitoring committee are
acknowledged under the ICH E6 (R3) Guideline on good clinical practice and EU Clinical
Trials Regulation. See “Regulation — Overview of EU Laws and Regulations.” The clinical
trial protocol and all subsequent amendments have been authorized by relevant health
authorities, and under the authorized clinical trial protocol, the data review team is authorized
to review the safety data and to confirm RP2D. As such, the authority of the data review team
is acknowledged by relevant authorities.
The approved clinical trial protocol does not require us to communicate with the relevant
health authorities or the EMA prior to the commencement of the Phase II trial, and therefore
we did not conduct such communications, in line with the common practice in similar
situations, according to Frost & Sullivan. In June 2024, we submitted a substantial
modification application to the Clinical Trials Information System (“ CTIS ”) maintained by the
EMA, in which we included an updated investigator’s brochure for GFH925 that contains (1)
the PK data from the Phase Ib trial and (2) the latest results, including the safety results, of 27
patients who had received treatment of the GFH925/cetuximab combination as of January 31,
2024. The said 27 patients included the 6 patients enrolled in the completed Phase Ib trial. As
of the Latest Practicable Date, the modifications had been authorized, and we had not received
any objections to the ongoing Phase II trial from the relevant healthcare authorities or the
EMA, and we have not received any objection or rejection from the MSCs via the CTIS to
commence the Phase II trial.
Phase II Trial
Trial Design. Up to 45 patients are designed to receive GFH925 at a dose of 600mg BID,
which has been confirmed as safe in the Phase Ib trial, in combination with cetuximab at dose
of 500 mg/m
2 once every two weeks in a 28-day cycle to evaluate efficacy. The primary
endpoint of Phase II trial is to evaluate overall response rate (“ ORR”). The secondary
endpoints are to evaluate (i) disease control rate (“ DCR”), DoR, TTR, PFS, and OS,
(ii) incidence of AEs and SAEs; (iii) changes in laboratory parameters, vital signs, physical
examinations, and electrocardiogram; (iv) trough concentration of GFH925 and
(v) concentration of GFH925 near the time of maximum concentration (“ T
max”).
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The key inclusion criteria for the trial include but not limited to: (i) male or female
patients aged 18 years or older; (ii) patients with a life expectancy greater than three months
judged by the investigator; (iii) patients with histologically or cytologically confirmed
advanced KRAS G12C-mutated NSCLC; (iv) patients with sufficient organ functions; and
(v) patients whose toxicities from prior antitumor therapy have resolved to baseline levels or
Common Terminology Criteria for Adverse Events Grade 1 (with neurotoxicity or alopecia not
greater than Grade 2). The key exclusion criteria for the trial include but not limited to:
(i) patients with clinically significant cardiovascular diseases; (ii) patients with active central
nervous system metastases and/or carcinomatous meningitis; (iii) patients with clinically
significant gastrointestinal diseases; (iv) patients with uncontrolled systemic diseases; or
(v) patients that have undergone major surgery within four weeks prior to the initiation of the
treatment.
Trial Status. The Phase II trial was initiated in October 2023. As of the 2024 ASCO
Cut-off Date, a total of 40 patients received the GFH925/cetuximab combination treatment. We
anticipate completing the Phase II trial in the fourth quarter of 2025.
Efficacy Data. Most patients (95.0%) were diagnosed with stage IV diseases, and 13
(32.5%) were with brain metastases. As of the 2024 ASCO Cut-off Date, a total of 33 patients
had at least one available post-treatment tumor assessment. Among these 33 patients, the ORR
was 81.8% with one complete response and the DCR was 100%. Seven out of ten patients
(70.0%) with brain metastases achieved partial responses. The results demonstrate a promising
efficacy profile of GFH925 in combination with cetuximab as the first line treatment for KRAS
G12C mutated NSCLC.
As of January 14, 2025, a total of 47 patients were enrolled and 45 of them received at
least one post-treatment tumor assessment: the ORR reached 80% and the DCR reached 100%.
The post-treatment evaluation revealed 3 patients achieved complete response; 33 others
reached partial response, including one with 100% tumor shrinkage; 57.8% of patients
exhibited /H1135050% tumor shrinkage. As of the data cut-off date, the median follow-up time was
12.8 months, and the median progression-free survival was 12.5 months. 34% of enrolled
patients had baseline brain metastasis, and the ORR was 71.4% per RECIST 1.1 among
brain-metastatic patients who received at least one post-treatment tumor assessment; all
non-target lesions of brain-metastatic patients disappeared or remained stable in the course,
and brain target lesions of 5 patients exhibited shrinkage. The data also showcased the
combination therapy’s superior therapeutic potential over immunotherapy or chemo-
immunotherapy in first-line KRAS-mutant NSCLC treatment: consistent response rates were
observed in KROCUS study across subgroups with varied PD-L1 expressions; since STK11
and KEAP1 have been identified as associated with a lower response to immunotherapy and
with poor prognosis for first-line NSCLC SOC, it’s noteworthy that similar responses were
discovered in KROCUS study between STK11 or KEAP1 wild-type patients and those with
STK11 or KEAP1 co-mutations. The above results of the Phase II trial were presented in a
late-breaking abstract at the mini oral presentation of the 2025 ELCC annual meeting.
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Safety Data. As of the 2024 ASCO Cut-off Date, among the 40 patients who received the
GFH925/cetuximab combination therapy, TRAEs of any grade occurred in 35 patients (87.5%).
Seven patients (17.5%) experienced Grade 3 TRAEs and the only treatment-related serious
adverse event of the combination therapy was assessed as not related to GFH925. The Grade
3 TRAEs included rash, asthenia, pruritus, eye infection, dry skin, skin fissures and
infusion-related reaction. One (2.1%) and four patients (10.0%), respectively, required dose
reductions or temporary interruptions of GFH925 treatment due to TRAEs but no patients
permanently discontinued GFH925 treatment. Three patients (7.5%) discontinued cetuximab
treatment due to TRAEs. Overall, the results demonstrate a favorable safety profile of the
combination therapy. The above results of the Phase II trial were presented as a late-breaking
oral presentation at the 2024 American Society of Clinical Oncology (“ ASCO ”) annual
meeting.
As of January 14, 2025, the combination therapy presented a favorable safety/tolerability
profile, with a lower incidence of TRAEs than that of fulzerasib monotherapy for second-line
and above NSCLC treatment; grade 3 or higher TRAEs occurred at a considerably lower rate
than that of fulzerasib monotherapy. TRAEs occurred in 87.2% of patients and the majority of
the TRAEs were graded 1-2; 14.9% of patients experienced at least one grade 3 TRAEs; no
grade 4-5 TRAEs. 2 patients had treatment-related serious adverse events (“ TRSAE ”) and the
TRSAEs were assessed to be merely related with cetuximab; 3 patients experienced TRAEs,
unrelated to fulzerasib, leading to dose discontinuation. The KROCUS study demonstrated a
relatively low occurrence of dose discontinuation or reduction among different first-line
G12C-mutant NSLCL combo studies. No new safety signals were identified compared with
fulzerasib or cetuximab as single agent. The above results of the Phase II trial were presented
in a late-breaking abstract at the mini oral presentation of the 2025 ELCC annual meeting.
GFH925X1101: A Phase I/II clinical trial to evaluate safety, tolerability, PK and efficacy in
patients with advanced solid tumors with KRAS G12C mutations in Mainland China sponsored
by Innovent and originally initiated by us
Overview. This trial is a multicenter, non-randomized, open-label, single-arm Phase I/II
clinical trial. The primary objective of the Phase Ia trial is to evaluate safety and tolerability
of GFH925 in patients with advanced solid tumors harboring KRAS G12C mutations, and to
determine the maximum tolerated dose (“ MTD”) and/or RP2D of GFH925. The primary
objective of the Phase Ib trial is to evaluate efficacy of GFH925 in patients with advanced
colorectal cancer or other tumors with KRAS G12C mutations. The primary objective of the
Phase II trial is to evaluate efficacy of GFH925 in patients with advanced NSCLC with KRAS
G12C mutations.
We led and were responsible all preclinical development of GFH925 and obtained an IND
approval addressed to our Company for GFH925X1101 from the NMPA in July 2021. In
preparation for the clinical trial and prior to entering into the GFH925 License Agreement, we
proactively identified and finalized the arrangement details with the lead principal investigator.
We also arranged eight clinical sites in multiple provinces in China, submitted materials for
ethics committee approvals for a number of these clinical sites, and activated one clinical trial
site in August 2021. Innovent later supported the clinical collaboration by expanding the trial
from eight clinical sites we initially arranged to a total of 55 clinical sites.
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After signing of the GFH925 License Agreement, Innovent became the sponsor of the
GFH925X1101 trial in China and is thereafter solely responsible for the development and
commercialization of GFH925 in the Greater China region. However, we retain a critical role
in managing the CMC-related processes, including overseeing process development, finalizing
agreements with key stakeholders, and selecting suitable vendors to ensure smooth trial
execution. Innovent will pay our Company for the drug supply on an ongoing basis, with
payments determined by the quantity required to support the trial’s development needs. For
additional information about the Innovent Agreement, see “— Licenses, Rights and
Obligations” below.
Clinical results from the Phase II trial supported the NDA approval of GFH925 in China
for the treatment of advanced NSCLC harboring KRAS G12C.
Design of the Phase II Trial . The Phase II trial enrolled a total of 116 patients with
advanced NSCLC with KRAS G12C mutations. All patients were treated with GFH925 at a
dose of 600 mg orally twice daily until intolerable toxicity or disease progression occurred.
The primary endpoint of the Phase II trial is ORR. The secondary endpoints include
(i) DCR, DoR, TTR, PFS, and OS, disease progression-free rate at six and 12 months, and
survival rate at 12 months; (ii) incidence and severity of AEs, SAEs, AEs leading to treatment
suspension, and AEs leading to treatment discontinuation; and (iii) plasma concentrations of
patients after multiple doses, including trough concentrations.
The key inclusion criteria for the trial include but not limited to: (i) patients aged 18 years
or older at the time of signing the informed consent form; (ii) patients with at least one
measurable lesion; and (iii) patients with an expected survival time of 12 weeks or more. The
key exclusion criteria for the trial include but not limited to: (i) patients with significant
cardiovascular system disease; (ii) patients with brain metastases judged unstable by the
investigators; (iii) patients with significant gastrointestinal disease; (iv) patients with
significant acute or chronic infections; or (v) patients that are allergic to the drug or any
component of its formulation.
Efficacy Data of the Phase II Trial. As of the data cut-off date of December 13, 2023, the
confirmed ORR was 49.1%, and the DCR was 90.5% in 116 patients. The median DoR was not
reached, and 75.8% and 53.7% patients had DoR at six months and 12 months, respectively.
The median of TTR was 1.38 months and the median PFS was 9.7 months. The median OS was
13.3 months, with six-month OS and 12-month OS of 81.8% and 54.4%, respectively.
Safety Data of GFH925. Results of 301 patients were used for the safety analysis of
GFH925. TRAEs occurred in 92.2% of patients. Most TRAEs are Grade 1 to 2. The most
common TRAEs included anemia, increased alanine aminotransferase, increased aspartate
aminotransferase, elevated blood bilirubin, asthenia, proteinuria, hypoproteinemia, pruritus,
edema, and elevated gamma-glutamyl transferase. The common AEs of Grade 3 and higher
include anemia, elevated gamma-glutamyl transferase, asthenia, hepatic dysfunction, elevated
blood alkaline phosphatase, and decreased lymphocyte counts. 14.0% of patients has SAE, and
2.7% of patients experienced AEs leading to drug discontinuation. 32.6% and 18.3% of patients
experienced AEs resulting in drug suspension and dose reduction, respectively.
The above clinical efficacy and safety data are included in the label of GFH925 in China.
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Clinical Development Plan
Our overseas clinical development of GFH925 has been focused on the
GFH925/cetuximab combination therapy as a first-line treatment of NSCLC, instead of
GFH925 as a monotherapy. This is because, when we started the clinical development of
GFH925, in multiple regions outside China, such as the U.S., certain drugs (e.g., sotorasib and
adagrasib) as monotherapies targeting the KRAS G12C mutation had received regulatory
approval for treating NSCLC as a standard of care in the second or later line treatment, and the
medical need for the first line treatment was not met.
We chose to conduct the KROCUS trial in EU where the population is considered
representative to the global-wise population and the trial is relatively cost-effective. The
planned Phase III clinical trial in the U.S. was designed to be part of a multi-regional study in
U.S. and EU, and may support future global registration in multiple regions. Conducting the
Phase III clinical trial in the U.S. would enable us to benefit from the fast and straightforward
U.S. IND process and to initiate communications with FDA to receive FDA ’s inputs on the
study design. The FDA ’s inputs may support further communications with the regulatory
authorities in EU and other regions. In EU, we plan to conduct the Phase III trial in Spain, Italy
and Greece. We would also consider conducting the Phase III trial in other EU member states
where there are extensive experience in conducting clinical trials and KRAS testing capacity
for lung cancers. Innovent will not be involved or co-lead this Phase III clinical trial as
sponsors.
We will continue to advance the clinical development of our Core Product GFH925 for
cancer treatment. We anticipate completing the KROCUS Phase II trial in the fourth quarter of
2025. We plan to leverage the clinical results of the KROCUS trial to apply for a Phase III
clinical trial in the United States to evaluate the safety and efficacy of the GFH925/cetuximab
combination therapy as a first-line treatment for NSCLC harboring the KRAS G12C mutation.
We had a pre-IND meeting with the FDA in February 2025 regarding our planned IND
application for a Phase III clinical trial. In the meeting, the FDA provided guidance on the
clinical development pathway for fulzerasib/cetuximab combination therapy as a first-line
treatment for NSCLC harboring the KRAS G12C-mutation. In particular, the FDA provided
requests and recommendations regarding the study protocol. Specifically, the FDA advised us
to, as part of the proposed Phase III clinical trial, (i) further optimize the dosages and (ii) assess
the contribution of each of GFH925 and cetuximab within the combination regimen in light of
the strong efficacy observed in GFH925 monotherapy trials. We expect to incorporate the
FDA’s requests and recommendations and prepare a revised study protocol for the planned
Phase III clinical trial. We expect to submit an IND application to the FDA for the Phase III
clinical trial in the third quarter of 2025 and initiate the trial in the fourth quarter of 2025.
Based on our communication with the FDA, we do not expect the guidance on “ Optimizing the
Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic
Diseases ” released by the FDA in August 2024 will have material impact on the development
of GFH925/cetuximab combination therapy in the U.S.. We expect to submit to the FDA an
NDA for the GFH925/cetuximab combination therapy in the fourth quarter of 2028 and obtain
the NDA approval in the fourth quarter of 2029. We also intend to submit a clinical trial
application for a Phase III clinical trial of the GFH925/cetuximab combination in selected
member states within the jurisdiction of the EMA in the second half of 2025.
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Beyond NSCLC, we view GFH925 as a potentially valuable therapeutic option in other
challenging cancers, such as advanced CRC. The FDA approved our IND application for a
Phase III clinical trial of GFH925 monotherapy as a later-line treatment for refractory
metastatic CRC harboring the KRAS G12C mutation in April 2024, based on the revised
protocol, informed consent document, and Investigator’s Brochure that we submitted in March
2024. However, because of commercial considerations of GFH925 in the CRC drug market and
the potential significant costs for further R&D, we are not currently actively pursuing the
clinical development of GFH925 as a potential treatment of CRC for commercial
considerations. We are currently assessing the competitive landscape and formulating future
clinical development plan of GFH925.
We independently designed and conducted the clinical trials of GFH925 in the EU and
U.S. Specifically, before the KROCUS trial, we conducted two preclinical studies in China to
test the antitumor effects of the GFH925/cetuximab combination on xenograft mouse models
of human NSCLC and PDAC cell lines, between December 2021 and March 2022. Both
preclinical studies showed good tolerability and considerable synergistic effect of the
GFH925/cetuximab combination compared with monotherapy. We are the sole sponsor of the
KROCUS study in the EU and expect to be sole sponsor of the planned Phase III clinical trial
of the GFH925/cetuximab combination therapy in the U.S. Innovent does not and will not have
any involvement in the two overseas studies. We retain the right to develop and commercialize
GFH925 in the overseas markets, and Innovent does not possess such a right. Also, we, not
Innovent, possess patents that cover GFH925. Therefore, our R&D and commercialization
efforts in the EU and/or U.S. are independent without any reliance on Innovent.
In our clinical trial application for the KROCUS study, we included a summary of the
clinical data generated from the GFH925X1101 study as required under the relevant
regulations, including the reference to the dosage and patient selection. The initial dosage of
GFH925 at 600 mg BID in the Phase Ib part of the KROCUS study was derived from the RP2D
determined in the Phase I part of Innovent’s GFH925X1101 study. As advised by Frost &
Sullivan, a study’s sponsor normally will review available clinical or non-clinical research data
relating to the investigational therapy to design its own study protocol, including the dosage
and patient selection. The Phase I clinical data of the GFH925X1101 study and the dosage
regimen of cetuximab at 500 mg/m
2 once every two weeks based on its prescribing information
approved by the FDA were such existing knowledge for the KROCUS study at its planning
stage. The RP2D that derived from the GFH925X1101 study provided a starting point for the
dosage selection of GFH925 in the KROCUS study. Since the safety of GFH925 in
combination with cetuximab was confirmed at 600 mg BID for GFH925 and 500 mg/m
2 once
every two weeks for cetuximab, we did not need to test other dosage levels per the dose
de-escalating design of the Phase Ib part, thereby saving considerable time and costs in dosage
selection.
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We are currently focused on the research and development of GFH925 in the Ex-China
Territory and have not yet formulated a detailed commercialization plan. However, we
currently expect GFH925 to be positioned with a competitive pricing strategy in the overseas
markets with other approved KRAS G12C inhibitor drugs, leveraging production cost
efficiencies anticipated from our second-generation manufacturing process. The pricing of
GFH925 in the EU and U.S. is expected to by higher than that in China. For information on
the regulatory pathways to marketing authorization in the EU and U.S., please refer to
“Regulations — Overview of EU Laws and Regulations” and “Regulations — Overview of
U.S. Laws and Regulations.”
Licenses, Rights and Obligations
Innovent Agreement
On September 1, 2021, we entered into a license and option agreement (the “ GFH925
License Agreement ”) with Innovent. According to the GFH925 License Agreement, we grant
to Innovent (i) an exclusive, royalty-bearing and sublicensable license to develop and
commercialize GFH925 for the treatment, prevention or diagnosis of any disease in humans in
Mainland China, Hong Kong, Macau and Taiwan (the “ Greater China ”); and (ii) an exclusive
option (the “ Ex-China Option ”) to develop and commercialize GFH925 in the all countries
and regions in the world other than Greater China (the “ Ex-China Territory ”). Prior to
entering into the GFH925 License Agreement, we proactively identified and finalized the
arrangement details with the lead principal investigator. Innovent later supported the clinical
collaboration by expanding the trial from the eight sites we initially arranged to a total of 55
clinical sites. After signing of the GFH925 License Agreement, Innovent became the sponsor
of the GFH925X1101 trial in China and is thereafter solely responsible for the development
and commercialization of GFH925 in the Greater China region. However, we retain a critical
role in managing the CMC-related processes, including overseeing process development,
finalizing agreements with key stakeholders, and selecting suitable vendors to ensure smooth
trial execution. Innovent will pay our Company for the drug supply on an ongoing basis, with
payments determined by the quantity required to support the trial’s development needs. On
January 11, 2024, we further entered into a supplementary agreement (the “ GFH925
Supplementary Agreement ,” together with the GFH925 License Agreement, the “ Innovent
Agreement ”) with Innovent. According to the GFH925 Supplementary Agreement, both parties
agreed to terminate the Ex-China Option under the GFH925 License Agreement. We have the
exclusive rights to develop, manufacture and commercialize GFH925 for any indication in the
Ex-China Territory. For more details, please see “— Major Collaboration and Licensing
Arrangements — Innovent Agreement.”
We collaborated with Innovent to facilitate the swift development and approval of
GFH925 for commercialization in China. This collaboration leveraged Innovent’s development
expertise in advancing clinical trials, as well as their leadership position in China, which
includes an established commercialization team and an extensive marketing network.
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The table lists the chronology on the material clinical development of GFH925 conducted
by us and Innovent in different regions.
GenFleet Innovent
China Europe U.S. China
2018 /H1118/H1118/H1118/H1118/H1118Commenced the
endeavor to discover
and develop GFH925
2021 /H1118/H1118/H1118/H1118/H1118July: Received the IND
approval from the
NMPA for GFH925 for
a Phase I/II clinical
trial in patients with
advanced solid tumors
with the KRAS G12C
mutation;
September: Entered into
collaboration
agreement with
Innovent in relation to
the clinical
development and
commercialization of
GFH925
September: Entered into
collaboration
agreement with the
Company in relation to
the clinical
development and
commercialization of
GFH925;
September: Completed
the first patient dosed
for Phase I/II clinical
trial of GFH925 in
Chinese patients with
solid tumors
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GenFleet Innovent
China Europe U.S. China
2022 /H1118/H1118/H1118/H1118/H1118March: completed
preclinical studies of
the antitumor effects
of the
GFH925/cetuximab
combination on
xenograft models of
human NSCLC and
PDAC cell lines;
June: Entered into a
clinical trial
collaboration and
supply agreement with
Merck Healthcare
KGaA to secure
cetuximab for the
KROCUS trial;
October: Submitted the
investigational
medicinal product
dossier to the CTIS
maintained by the
EMA for the KROCUS
trial, which is a Phase
Ib/II trial of GFH925
in combination with
cetuximab to assess
the combination
therapy as a first-line
treatment of advanced
NSCLC
June: The Phase I dose-
escalation study
results of GFH925 as
monotherapy were
released at the ASCO
Annual Meeting 2022;
H2: Initiated Phase Ib
studies for GFH925
combination therapy
for KRAS G12C
mutated cancers;
H2: Initiated the pivotal
Phase II study for
GFH925 for the
treatment of 2L KRAS
G12C mutated NSCLC
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GenFleet Innovent
China Europe U.S. China
2023 /H1118/H1118/H1118/H1118/H1118 March: Initiated the
KROCUS trial in Italy,
Spain and Greece;
October: The Phase Ib
trial of KROCUS
reached the primary
endpoints, and there
was no objection from
the data review team
or relevant health
authorities to the
commencement of the
Phase II trial
January and May: The
GFH925 monotherapy
received two
Breakthrough Therapy
Designations from the
NMPA for treating
advanced KRAS
G12C-mutant NSCLC
and CRC patients;
June: Entered into a
clinical trial
collaboration and
supply agreement with
Merck KGaA for the
combination therapy of
GFH925 with
cetuximab
(ERBITUX
®) for
KRAS G12C-mutated
NSCLC in a Phase Ib
study in China;
November: The NMPA
accepted the NDA and
granted Priority
Review Designation
for GFH925
monotherapy in
patients with
previously treated
advanced NSCLC
harboring KRAS
G12C mutation who
have received at least
one systemic therapy
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GenFleet Innovent
China Europe U.S. China
2024 /H1118/H1118/H1118/H1118/H1118 June: Reported the
results of the
KROCUS trial for
GFH925 as a late-
breaking oral
presentation at the
2024 American
Society of Clinical
Oncology annual
meeting
April: The FDA
approved the Phase III
clinical trial of
GFH925 for the
treatment of refractory
metastatic CRC
patients
Initiated a Phase Ib/III
clinical trial to
investigate GFH925/
cetuximab combination
therapy in patients
with previously
untreated advanced
NSCLC harboring
KRAS G12C mutation;
August: GFH925
(marketed under the
name Dupert
®) was
approved by NMPA
for the treatment of
patients with advanced
NSCLC harboring
KRAS G12C mutation
who have received at
least one systemic
therapy
2025 /H1118/H1118/H1118/H1118/H1118 March: Reported the
results of the latest
phase II data of the
KROCUS trial for
GFH925 in a late-
breaking abstract at
the mini oral
presentation of the
2025 European Lung
Cancer Conference
annual meeting
Merck Agreement
On June 30, 2022, we entered into a clinical trial collaboration and supply agreement (the
“Merck Agreement ”) with Merck Healthcare KGaA in relation to the clinical development of
the GFH925/cetuximab combination therapy for a Phase Ib/II clinical trial (i.e.,
GFH925X0201) in the EU. According to the Merck Agreement, Merck is obligated to provide
cetuximab for the use in the clinical trial to us with a maximum number of 3,500 vials and
schedule specified in the Merck Agreement according to the clinical trial status and subject to
mutual agreement between Merck and our Company. Our Company shall bear all other costs
associated with the subject clinical trial. The Merck Agreement does not affect our status as the
sole sponsor of or our sole responsibility to conduct the KROCUS trial. The Merck Agreement
does not provide for a JSC.
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The Merck Agreement stipulates that all rights to all inventions that are directed to the
combination therapy and variants thereof, except those inventions solely relating to GFH925
or cetuximab, shall be jointly owned by Merck and our Company. Those inventions solely
relating to GFH925 or cetuximab shall be solely owned by GenFleet or Merck, respectively.
The Merck Agreement allows us to freely exploit such joint inventions and does not provide
for payment obligations in connection with any licensing arrangement or Merck’s provision of
cetuximab. Where a license is required, Merck grants to us a perpetual, irrevocable,
non-exclusive, worldwide, royalty-free, fully paid-up license under Merck’s right, title and
interest in and to all joint inventions to use such inventions for any use, and vice versa.
Accordingly, if a joint invention is developed through potential future collaboration with
Merck, each party (i.e. we and Merck) is permitted to use and freely exploit such joint
invention without any costs and without written consent from the other party in accordance
with the Merck Agreement. The Merck Agreement granted us the first right (but not the
obligation) to file, maintain and defend the patents that cover the joint inventions. However,
if we do not want to file or share expenses for a patent application that covers the joint
inventions, Merck may at its own expenses continue to file, maintain and defend such a patent
application. Also, under the Merck Agreement, we need Merck’s consent in making disclosures
to the patent authority regarding jointly inventions. The Merck Agreement does not otherwise
affect our existing ownership of intellectual property rights over GFH925. As of the Last
Practicable Date, neither party has obtained any patent or filed any patent application for the
joint inventions under the Merck Agreement.
Each party agreed to customary indemnification to the other party in relation to losses
attributable to such party’s product and, in case of Company, arising from the trial of
GFH925/cetuximab combination therapy.
Merck and we agreed to attempt in good faith to settle all disputes arising out of the
Merck Agreement in an amicable manner. If such disputes cannot be so resolved, they shall be
finally settled at the competent courts of Geneva, Switzerland. During the Track Record Period,
we did not have any unresolvable dispute with Merck.
The term of the Merck Agreement shall continue until completion of all of the obligations
of the parties. Either party may terminate the Merck Agreement (i) when the other party
commits a material breach and fail to remedy in a specified period, (ii) when the party
reasonably determines in good faith, after a review of relevant information, that the trial may
unreasonable affect patient safety, (iii) by providing written notice in specified events,
including regulatory action or manufacturing or supply chain disruption, (iv) by providing
advance written notice in case the study fails to reach any of its endpoints. Merck may
terminate the Merck Agreement if it reasonably and in good faith believes that the supplied
cetuximab is being used in the trial in an unsafe manner or there is imminent danger to patients,
and we fail to promptly incorporate appropriate changes to address such issues after we receive
notification from Merck.
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Material Communications with Competent Authorities
Regarding the KROCUS Trial
EMA
The EMA is a decentralized agency of the EU and is responsible for the scientific
evaluation, supervision and safety monitoring of medicines. It plays a key role in ensuring that
the standards of good clinical practice are applied in cooperation with EU member states and
manages clinical trial databases, including CTIS, for clinical trials that are carried out in the
EU. The CTIS serves to implement the EU Clinical Trials Regulation, Regulation (EU) No
536/2014, and supports interactions between clinical trial sponsors and regulatory authorities
in the EU member states throughout the lifecycle of a clinical trial. The EMA evaluates the
marketing authorization applications (“ MAAs ”) submitted through the centralized procedure
and its evaluation provides the basis for the authorization of medicines in Europe.
According to EMA, it does not evaluate applications for the authorization of clinical
trials. Instead, such authorization occurs at EU member state level. The Clinical Trials
Regulation enables sponsors to submit one online application via the CTIS maintained by the
EMA, through which regulators and authorities of each state can collaboratively process
clinical trial applications, request further information, authorize or refuse a trial and oversee
an authorized trial. The evaluation process of an initial clinical trial application includes three
main phases: validation, assessment and decision. The assessment phase includes two parts:
Part I and Part II.
 Part I consists in a joint assessment by the member states concerned (“ MSCs ”) led
by the reporting member state (“ RMS”) on aspects primarily related to scientific
documentation, manufacturing and importing requirements, labeling requirements
and completeness and adequateness of the investigator’s brochure.
 Part II consists in a separate assessment performed by each MSC, each of which
results in the submission of an individual conclusion. The scope of the Part II
assessment is set out in the Clinical Trial Regulation and primarily relate to aspects
such as informed consent, compensation, protection of data and samples, patient
recruitment and suitability of clinical trial sites.
Request for information (“ RFIs ”) may be raised by RMS for Part I or by the MSC for Part
II. Each MSC decides if the application is complete and adequate, and therefore if the clinical
trial can be conducted in its territory.
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On October 14, 2022, pursuant to the Clinical Trials Regulation (EU) No. 536/2014CTR,
we independently prepared and submitted to the CTIS a clinical trial application for the
KROCUS study. The application included IMPD, Investigator’s Brochure (“ IB”), clinical study
protocol (the “ Protocol ”) and informed consents of clinical trial participants. The IMPD
presented the detailed data of GFH925 regarding its manufacturing and formulation. The IB
presented detailed data generated in the prior non-clinical and clinical studies of GFH925, and
the only clinical study mentioned therein was the GFH925X1101 study. The Protocol
elaborated the design, procedure and data analysis planned for the KROCUS study. The
introduction part of the Protocol, which explained the scientific basis of the study, summarized
the clinical data generated from the GFH925X1101 study (including the dosage and safety
profile of GFH925 in the study). In addition, we take the initiative and are responsible for
drafting and leading the annual updates of the IB.
On November 14, 2022, our clinical trial application was validated. On February 20,
2023, the Italian health authority submitted the part I evaluation report, including a favorable
conclusion. The Italian and Spanish health authorities submitted the part II evaluation report
with a favorable conclusion on February 20, 2023 and January 12, 2023, respectively.
Subsequently, both countries’ health authorities authorized the KROCUS study in their
respective jurisdictions on February 23, 2023. On June 20, 2023, Greece agreed to be added
as an MSC.
The French authority declined to authorize our clinical trial application in June 2023,
noting a lack of clinical data at the time that may guarantee a favorable benefit/risk balance of
the GFH925/cetuximab combination therapy in the KROCUS study. The decision of the French
authority would not have any adverse or knock-on impact on the ongoing clinical development,
market registration application, and commercialisation plans of the GFH925 in other member
states under the EMA regime. The marketing authorization application of the
GFH925/cetuximab combination therapy, as a new active substance indicated for the treatment
of cancer, is expected to follow the centralised procedure. Accordingly, we expect to submit via
the CTIS a single marketing application for the combination therapy. Under the EMA
centralised procedure, if the GFH925/cetuximab combination therapy is approved by the
European Commission, we will obtain a single marketing authorization valid in all E.U.
member states, including France and other member states, even though the clinical trial of the
GFH925/cetuximab combination therapy has not been conducted in France and such other
member states or France declined to authorize clinical trial application of the
GFH925/cetuximab combination therapy. For more details, please refer to “Regulations —
Overview of EU Laws and Regulations.”
We initially selected Greece, Italy, France, and Spain as the sites for the KROCUS study
because these EU member states have relatively large populations, well-developed healthcare
systems, and extensive experience in conducting clinical trials. These factors facilitated patient
recruitment and enabled the smooth execution of the study at local hospitals. In addition, these
countries have relatively greater openness to innovative trial designs within the EU, such as the
combination study we are conducting. We have successfully recruited a sufficient number of
patients from Greece, Italy, and Spain to meet the requirements set forth in the approved trial
protocol. Accordingly, we believe the selection of the participating member states in the E.U.
is sufficient for the approved clinical development purpose.
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Following the authorization of the KROCUS trial, we made five substantial modifications
(“SM”) through the CTIS, with two of them involving the Part I (SM-3 and SM-4 below).
According to the EU Clinical Trials Regulation, a substantial modification is any change to any
aspect of a clinical trial, which is likely to either have a substantial impact on subjects’ safety
or rights or on the reliability and robustness of the data generated in the clinical trial. A
substantial modification may only be implemented if it has been authorized by the MSCs
through CTIS maintained by the EMA. Through these modifications, we have ongoing
communications via CTIS with the EMA and MSCs by updating information, including the
investigator’s brochure that contains updated clinical trial results, about the ongoing KROCUS
trial. As of the Latest Practicable Date, we had not received any objections to the ongoing
Phase II trial from the relevant healthcare authorities, any relevant MSC, or the EMA, and we
do not expect to make further SMs.
The following table sets out information about those five substantial modifications, which
had all been authorized by the relevant MSCs.
Primary purpose/
Major changes
Initial
submission date Status
SM-1 /H1118/H1118/H1118/H1118We added six new clinical trial
sites in Spain.
March 17, 2023 The proposed modifications
were authorized on April 27,
2023, by Spain through CTIS
maintained by the EMA.
There were no other
comments/feedbacks from
CTIS maintained by the
EMA after the submission of
evaluation reports by each
relevant MSC.
SM-2 /H1118/H1118/H1118/H1118We added four new clinical trial
sites in Italy.
April 26, 2023 The proposed modifications
were authorized on June 21,
2023, by Italy through CTIS
maintained by the EMA.
There were no other
comments/feedbacks from
CTIS maintained by the
EMA after the submission of
evaluation reports by each
relevant MSC.
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Primary purpose/
Major changes
Initial
submission date Status
SM-3 /H1118/H1118/H1118/H1118We updated the protocol for
GFH925 to include (1) new
preclinical data and (2) changes
on definition of the end of the
trial and eligibility criteria. We
changed the definition from “the
time when the last enrolled
patient has been under study
treatment for at least 1 year or
discontinued for any reason
(whichever is earlier)” to “the
time when the last on treatment
patient has been under study
treatment for at least 1 year or
discontinued for any reason
(whichever is earlier),” because,
during the KROCUS study, we
found the revised definition is
more reasonable than the
previous one and therefore
submitted SM-3 to reflect the
same. We also updated
nonclinical and clinical data
regarding GFH925 and its
combination therapies (including
the clinical data from the
KROCUS study, as well as
dosage and safety profile of
GFH925 in the GFH925X1101
study), as well as reference
safety information in the
investigator’s brochure for
GFH925.
September 1, 2023 The proposed modifications
were authorized to be made
to the protocol and
investigator’s brochure on
November 6, 2023,
November 2, 2023, and
November 7, 2023, by Italy,
Spain and Greece,
respectively, through CTIS
maintained by the EMA.
There were no other
comments/feedbacks from
CTIS maintained by the
EMA after the submission of
evaluation reports by each
relevant MSC.
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Primary purpose/
Major changes
Initial
submission date Status
SM-4 /H1118/H1118/H1118/H1118We updated the investigator’s
brochure for GFH925 to include,
among others, (1) the PK data
from the Phase I trial, (2) the
latest results, including the
safety results, of 27 patients
who had received treatment of
the GFH925/cetuximab
combination as of January 31,
2024, and (3) the latest safety
and efficacy results of the
GFH925X1101 study as of
December 13, 2023. We also
updated the informed consent
form, which mentioned updated
safety data of the KROCUS
study, in line with the new
investigator’s brochure. SM-4
represented a routine process of
updating the investigator’s
brochure annually on the clinical
and non-clinical study results of
the study drug. We made the
updates without any health
authorities’ request.
June 20, 2024 The proposed modifications
were authorized to be made
to the investigators’ brochure
and the informed consent
form on September 11, 2024,
August 27, 2024, and
September 12, 2024,
respectively, by Italy, Spain
and Greece through CTIS
maintained by the EMA.
There were no other
comments/feedbacks from
CTIS maintained by the
EMA after the submission of
evaluation reports by each
relevant MSC. In particular,
as of the date of the
Prospectus, we have not
received further updates from
the member states of Italy,
Spain and since the
submission of SM-4.
SM-5 /H1118/H1118/H1118/H1118We changed a principal
investigator for a clinical trial
site in Spain, because the
previous principal investigator
left that principal investigator
position on July 30, 2024.
October 3, 2024 The proposed modification was
authorized on October 23,
2024, by Spain through CTIS
maintained by the EMA.
There were no other
comments/feedbacks from
CTIS maintained by the
EMA after the submission of
evaluation reports by each
relevant MSC.
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Regarding the GFH925X1101 Trial in China
We conducted all preclinical development of GFH925 and submitted an IND application
for the first-in-human GFH925X1101 trial to the NMPA in May 2021. We were responsible for
the trial design that resulted in the NMPA ’s approval in July 2021, addressed to our Company
without any significant inquiries or objections. In preparation for the clinical trial and prior to
entering into the GFH925 License Agreement, we proactively identified and finalized the
arrangement details with the lead principal investigator. We also arranged eight clinical sites
in multiple provinces in China, submitted materials for ethics committee approvals for a
number of these clinical sites, and activated one clinical trial site in August 2021. Innovent
later supported the clinical collaboration by expanding the trial from the eight sites we initially
arranged to a total of 55 clinical sites.
After signing of the GFH925 License Agreement, Innovent became the sponsor of the
GFH925X1101 trial in China and is thereafter solely responsible for the development and
commercialization of GFH925 in the Greater China region. However, we retain a critical role
in managing the CMC-related processes, including overseeing process development, finalizing
agreements with key stakeholders, and selecting suitable vendors to ensure smooth trial
execution. Innovent will pay our Company for the drug supply on an ongoing basis, with
payments determined by the quantity required to support the trial’s development needs. For
additional information about the Innovent Agreement, see “— Licenses, Rights and
Obligations” above.
On August 20, 2024, the NMPA approved GFH925 for the treatment of patients with
advanced NSCLC harboring KRAS G12C who have received at least one systemic therapy.
In the United States
We submitted an IND application to the FDA on March 18, 2024 for a Phase III clinical
trial to investigate the safety and efficacy of GFH925 monotherapy as a later-line treatment for
refractory metastatic CRC harboring the KRAS G12C mutation in the United States. The FDA
communicated with us their comments and requests for additional clinical information on April
4, 2024. In their letter dated April 4, 2024, the FDA requested us to (i) modify the protocol to
require a treatment hold for Grade 3 nausea, vomiting, or diarrhea and treatment
discontinuation for Grade 4 vomiting or diarrhea; (ii) modify the protocol to include AEs that
would not require permanent discontinuation for a Grade 4 event; and (iii) submit the most
recent copy of the protocol for the dose finding study conducted in China. We submitted our
responses to the FDA on April 11, 2024, which included dosage and safety data of GFH925 in
the Phase I part of the GFH925X1101 study. There were no material inquiries or comments that
we were unable to address. Thereafter, the FDA issued the “study may proceed” letter on April
17, 2024, allowing us to conduct the proposed Phase III clinical trial. However, because of
commercial considerations of GFH925 in the CRC drug market and the potential significant
costs for further R&D, we are not currently actively pursuing the clinical development of
GFH925 as a potential treatment of CRC, as the substantial R&D expenses required may
outweigh the potential benefits in light of the regulatory approval of competing products. We
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are currently assessing the competitive landscape and formulating future clinical development
plan of GFH925. Accordingly, we have not conducted R&D activities of GFH925 as a potential
treatment for CRC after the FDA issued the “study may proceed” letter, and we have not
initiated the Phase III clinical trial of GFH925 targeting CRC. We currently have no concrete
plan to further conduct clinical trials of GFH925 targeting CRC, and we do not plan to allocate
any net proceeds from this Listing for such clinical trials.
We are aware of the guidance on “ Optimizing the Dosage of Human Prescription Drugs
and Biological Products for the Treatment of Oncologic Diseases ” released by the FDA in
August 2024. Given we received the “study may proceed” letter prior to the release of such
guidance and our Phase III clinical trial in the U.S. is not a dose finding trial, we do not expect
such guidance will have material impact on the development of GFH925 in the U.S. We had
not received any relevant regulatory agency’s objections to our clinical development plans as
of the Latest Practicable Date.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET GFH925
SUCCESSFULLY.
Core Product GFH375: A Small Molecule Inhibitor of KRAS G12D
Overview
GFH375 is an orally bioavailable, potent and selective small molecule inhibitor targeting
both the “on” GTP-bound and “off” GDP-bound states of KRAS protein with G12D mutation.
KRAS G12D mutation is the most prevalent oncogenic KRAS variant found in human cancers
that lacks approved treatment options. Preclinical results demonstrate low-nanomolar binding
affinity, favorable safety, oral bioavailability and potent activity for GFH375 in solid tumor
models. We are currently conducting a Phase I/II trial to evaluate safety and tolerability, PK,
and efficacy of GFH375 in patients with advanced solid tumors harboring the KRAS G12D
mutation in China. PDAC has emerged as the lead indication of GFH375. As of the Latest
Practicable Date, no drugs targeting the KRAS G12D mutation had been approved for
marketing globally, and GFH375 was among the most advanced orally bioavailable KRAS
G12D inhibitors in the world in terms of development status, according to Frost & Sullivan.
We believe that GFH375 has the potential to be an effective treatment for cancer harboring
KRAS G12D mutation.
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Mechanism of Action
KRAS is the most commonly mutated oncogene in human cancers. The KRAS G12D
mutation accounts for approximately 29% of all KRAS mutations, making it the most prevalent
variant in human cancers. The KRAS G12D mutation is particularly frequent in pancreatic
cancer (approximately 35%), CRC (approximately 12%) and NSCLC (approximately 4%).
In comparison to the KRAS G12C mutation, the KRAS G12D mutation causes a more
significant disruption of intrinsic GTPase activity, resulting in a higher proportion of active
GTP-bound KRAS in tumor cells. GFH375 is a KRAS G12D inhibitor that targets both the
“on” GTP-bound and “off” GDP-bound states of KRAS proteins, allowing it to effectively
inhibit KRAS protein function. Consequently, GFH375 blocks the GDP-GTP exchange,
preventing the activation of KRAS G12D in tumor cells and subsequently disrupting its
interaction with downstream proteins, such as RAF kinases.
Advantages of GFH375
We believe that GFH375 has the following advantages:
Highly potent dual (“off” and “on”) KRAS G12D inhibitor
In preclinical studies, GFH375 demonstrated its potential as a specific KRAS G12D
inhibitor targeting both active and inactive KRAS. Results from the nucleotide exchange assay
showed that GFH375 inhibited SOS1-mediated transition of GDP-bound KRAS G12D mutant
to GTP-bound state, with IC
50 value of 6 nM. In KRAS-RAF1 binding assay, GFH375
prevented GTP-analog (GMPPNP)-preloaded KRAS G12D from interacting with their effector
protein RAF1 in the reconstituted setting with IC
50 value of 2 nM.
Favorable tolerability in preclinical studies
GFH375 has demonstrated favorable tolerability in preclinical studies. For instance,
GFH375 had no effect on the central nervous and respiratory systems of Sprague Dawley rats,
nor on the cardiovascular system of beagle dogs following a single dose administration. In
addition, no death occurred in a 28-day repeated dose toxicity study with beagle dogs.
Repeated dosing of GFH375 also showed no impact on the electrocardiograms of the beagle
dogs.
Favorable activity in preclinical studies
GFH375 has demonstrated preclinical antitumor activity in controlling tumor growth in
different pancreatic cancer and CRC models. The following diagrams depict the dose-
dependent antitumor activity of GFH375 in multiple tumor models via oral administration.
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Source: Company information
Notes: AsPC-1 and Panc04.03 are cell lines originally derived from different pancreatic cancer patients. LS513 and
GP2D are cell lines originally derived from different patients with colorectal cancer. The above graphs show
results of CDX experiments, which involve implanting human cancer cell lines into immunodeficient mice
to study tumor growth and test activities of potential treatments in reducing tumor growth.
The significant antitumor activity of GFH375 was also observed in intracranial tumor
models, demonstrating GFH375’s potential to inhibit brain metastasis.
Differentiated route of administration
GFH375 differentiates itself from other product candidates currently under development
for KRAS G12D in terms of route of administration. In the preclinical study, GFH375
demonstrated moderate to high absolute bioavailability across various species, suggesting that
GFH375 can be orally available in human. Clinical research indicates that the exposure to
GFH375 increases in a dose-dependent manner following once-daily oral dosing. Notably,
antitumor activities have been observed at starting doses. Formulated as a once-daily, orally
available treatment, we believe GFH375 could potentially ease repeated drug administration,
improve patient compliance, and therefore potentially increase the overall efficacy of the
treatment regimen.
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Summary of Clinical Trials
We retain all rights of GFH375 in Greater China, and we are conducting a Phase I/II
clinical trial of GFH375 in China (i.e., GFH375X1101). We received IND approval from the
NMPA in June 2024 to initiate the clinical trial. We completed the Phase I part of the clinical
trial in January 2025 and initiated the Phase II part in February 2025. The following sets forth
an overview of the clinical trial of GFH375.
GFH375X1101: A Phase I/II clinical trial to evaluate safety, tolerability, and preliminary
efficacy of GFH375 in patients with advanced solid tumors harboring the KRAS G12D
mutation in China sponsored by us
Overview. This is a multicenter, non-randomized, open-label, single-arm Phase I/II
clinical trial to evaluate safety, tolerability, PK, and efficacy of GFH375 in patients with
advanced solid tumors harboring the KRAS G12D mutation.
The primary objective of the Phase I trial is to evaluate safety and tolerability of GFH375
in patients with advanced G12D-mutant solid tumors and determine the MTD and RP2D of
GFH375. The primary objective of Phase II trial is to evaluate efficacy of GFH375 in patients
with advanced solid tumors, including pancreatic ductal adenocarcinoma, CRC, NSCLC and
other solid tumors.
The Phase I trial
Trial design. In the Phase I trial, approximately 30 patients will be enrolled and treated
with GFH375 administered orally QD for 21-day treatment cycles. Patients will be assigned to
sequentially escalating dose groups at doses of 100 mg, 200 mg, 400 mg, 600 mg, 750mg and
900 mg, with three to six patients enrolled at each dose level. During such dose escalation,
patients may be administered GFH375 BID for dose finding. If no DLT event occurs during the
first treatment cycle, patients will continue to receive treatment and may receive dose
adjustments until disease progression, intolerable toxicity, or termination for other reasons.
The primary endpoints of the Phase I clinical trial are to evaluate (i) the incidence and severity
of AEs and SAEs, (ii) changes in laboratory tests, vital signs, and electrocardiogram; and (iii)
the incidence of DLT. The secondary endpoints of the Phase I study include evaluating (i)
plasma concentrations and PK profile, and (ii) ORR, DoR, DCR, TTR, PFS and OS. The above
trial design is in line with a conventional Phase I clinical trial.
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The key inclusion criteria for the trial include but not limited to: (i) male or female
patients aged between 18 and 75 years; (ii) patients with a life expectancy of 12 weeks or more;
(iii) patients with histologically or cytologically confirmed advanced or metastatic solid tumors
harboring the KRAS G12D mutation; and (iv) patients with at least one measurable lesion. The
key exclusion criteria for the trial include but not limited to: (i) patients with active brain
metastases; (ii) patients with poorly controlled or severe cardiovascular disease; (iii) patients
with active hepatitis B or active hepatitis C viruses; (iv) patients with combined major acute
or chronic infectious diseases; or (v) patients who have completed palliative radiotherapy
within 14 days prior to the first dose.
Scope of IND Approval. An “umbrella” approval of the Phase I and Phase II clinical trials
of GFH375 in patients with advanced solid tumors harboring the KRAS G12D mutation in
China were granted by the NMPA in June 2024. As of the Latest Practicable Date, all the
ongoing and planned clinical trials of GFH375 in China are under this “umbrella” IND
approval. The IND approval and the approved trial protocol did not specify the intended line
of treatment. No head-to-head comparison is required or planned prior to the pivotal trial.
Status. The Phase I clinical trial was initiated in July 2024 and the safety evaluation was
completed in January 2025. Based on the trial results, we determined the RP2D to be 600mg.
Safety Data of the Phase I Trial . As of the data cut-off date of January 17, 2025, no death
or DLT occurred in the trial. The incidences of Grade 3 or higher TEAEs/TRAEs, SAEs,
treatment related SAEs, and the termination/dosage reduction/suspension of clinical trial
caused by these AEs, for different dosage cohorts, are summarized below.
100 mg
QD (n=1)
200 mg
QD (n=1)
400 mg
QD (n=7)
600 mg
QD (n=10)
750 mg
QD (n=8)
900 mg
QD (n=3)
300 mg
BID (n=3)
Total
(n=33)
Grade 3 or higher
TEAEs /H1118/H1118/H1118/H1118/H1118/H11181(100.0%) 0 5(71.4%) 4(40.0%) 2(25.0%) 0 2(66.7%) 14(42.4%)
Grade 3 or higher
TRAEs /H1118/H1118/H1118/H1118/H1118/H11181(100.0%) 0 3(42.9%) 3(30.0%) 1(12.5%) 0 2(66.7%) 10(30.3%)
SAEs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181(100.0%) 0 1(14.3%) 2(20.0%) 1(12.5%) 0 1(33.3%) 6(18.2%)
Treatment Related
SAEs /H1118/H1118/H1118/H1118/H1118/H1118/H11181(100.0%) 0 0 1(10.0%) 0 0 1(33.3%) 3(9.1%)
Trial termination
caused by AE /H1118/H1118/H1118 0 0 0 2(20.0%) 0 1(33.3%) 0 3(9.1%)
Trial termination
caused by TRAE /H1118 0 0 0 1(10.0%) 0 1(33.3%) 0 2(6.1%)
Dosage reduction
caused by AE /H1118/H1118/H1118 0000 1(12.5%) 0 0 1(3.0%)
Dosage reduction
caused TRAE /H1118/H1118/H1118 0000 1(12.5%) 0 0 1(3.0%)
Trial suspension
caused by AE /H1118/H1118/H11181(100.0%) 0 5(71.4%) 1(10.0%) 1(12.5%) 0 2(66.7%) 10(30.3%)
Trial suspension
caused by TRAE /H1118 1(100.0%) 0 4(57.1%) 1(10.0%) 0 0 2(66.7%) 8(24.2%)
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A total of 10 patients experienced Grade 3 or higher TRAEs, which included diarrhea,
increased aspartate aminotransferase, increased gamma-glutamyl transferase, fatigue,
decreased white blood cell count, decreased neutrophil count, liver dysfunction, anemia,
hypokalemia and syncope.
Under the study protocol, one or more dose groups may be selected to enroll additional
subjects as backfilling cohorts to receive a dose of GFH375 monotherapy that has been
confirmed to be safe and well-tolerated and that has been assessed by the investigator and
sponsor as potentially clinically beneficial, in order to better estimate the RP2D of GFH375
monotherapy and characterize its safety, tolerability, PK and efficacy. Accordingly, after the
reach of Phase I primary end points and confirm of RP2D dose at 600 mg, we voluntarily chose
to continue to enroll backfilling cohort at 400 and 600 mg QD dose groups to further
characterize the pharmacokinetics, efficacy as well as safety of GFH375 as a monotherapy.
Accordingly, the Phase I clinical trial enrolled a total of 62 patients, including 33 patients for
the primary safety evaluation to determine whether the primary endpoints were met, and an
additional 29 patients as part of the backfilling cohort. As of the data cutoff date of March 31,
2025, among the 62 patients enrolled, there were no DLTs observed across all dose levels
(100-900 mg QD and 300 mg BID), and the TRAEs were mostly Grade 1/2. The most common
TRAEs occurring in at least 20% of patients were diarrhea, nausea, vomiting, and anemia.
TRAEs /H11350Grade 3 consisted mainly of decreased neutrophil count (8%) and diarrhea (5%). No
TRAE-related deaths were reported. The following tables summarizes TRAEs observed as of
the data cutoff date of March 31, 2025:
All Patients
(N=62)
400mg QD + 600mg QD + 300mg BID
(N=49)
Any Grade /H11350Grade 3 Any Grade /H11350Grade 3
Any TRAE /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111862 (100%) 18 (29%) 49 (100%) 15 (31%)
TRAEs occuring in /H1135020% of
patients, n (%)
Diarrhea /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111843 (69%) 3 (5%) 34 (69%) 2 (4%)
Nausea /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111842 (68%) 0 (0%) 34 (69%) 0 (0%)
V omiting /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111838 (61%) 1 (2%) 29 (59%) 1 (2%)
Anemia /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111832 (52%) 0 (0%) 26 (53%) 0 (0%)
Decreased appetite /H1118/H1118/H1118/H1118/H1118/H1118/H111824 (39%) 0 (0%) 20 (41%) 0 (0%)
Neutrophil count decreased /H1118/H1118 21 (34%) 5 (8%) 17 (35%) 4 (8%)
White blood cell count
decreased /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820 (32%) 1 (2%) 15 (31%) 1 (2%)
AST increased /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820 (32%) 1 (2%) 16 (33%) 0 (0%)
Hypoalbuminaemia /H1118/H1118/H1118/H1118/H1118/H1118/H111817 (27%) 0 (0%) 12 (24%) 0 (0%)
Asthenia /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111817 (27%) 1 (2%) 15 (31%) 1 (2%)
ALT increase /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815 (24%) 0 (0%) 13 (27%) 0 (0%)
TRAEs leading to dose
reduction, n (%) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11187 (11%) 3 (5%) 5 (10%) 1 (2%)
TRAEs leading to dose
interruption, n (%) /H1118/H1118/H1118/H1118/H1118/H1118/H111813 (21%) 7 (11%) 9 (18%) 6 (12%)
TRAEs leading to treatment
discontinuation, n (%) /H1118/H1118/H1118/H1118/H11182 (3%) # 2 (3%) 2 (4%) 2 (4%)
Treatment Related SAEs, n (%) 6 (10%) 5 (8%) 5 (10%) 4 (8%)
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Notes:
Percentage (%) is rounded to the nearest whole number.
Time from first dosing to safety data cutoff is at least 26 days. Median time on treatment was 6.4 weeks (range:
0.1-38.0)
# The two patients discontinued treatment due to G3/4 hepatic function abnormality, both were treated at 600
mg QD.
As of the data cutoff date of May 16, 2025, among the 52 patients across all dose levels
and indications who received at least one post-treatment tumor assessment (efficacy
evaluable): the overall ORR was 38% and DCR was 90%; 38 patients exhibited reduction in
target lesion, and 20 patients achieved partial response.
As of the data cutoff date of May 16, 2025, among 49 patients orally administered at daily
dosages of 400 or 600 mg: 43 patients who received at least one post-treatment tumor
assessment achieved an ORR of 42% and a DCR of 91%; the ORR was 52% and DCR was
100% among 23 efficacy-evaluable PDAC patients, and the ORR was 42% and DCR was 83%
among 12 efficacy-evaluable NSCLC patients. Pharmacokinetic analysis revealed the dose
levels of 400 mg and 600 mg QD were able to achieve average trough concentrations that were
three times above the IC90 value for p-ERK inhibition in AsPC-1 cells. Moreover, 600 mg QD
has been recommended as the phase II dose (RP2D) for the phase II portion which started in
February 2025.
Phase II trial
Trial design . The Phase II trial plans to enroll approximately 317 subjects with advanced
solid tumors with KRAS G12D mutations to receive continuous monotherapy with GFH375 at
RP2D for 21 days. Patients will receive GFH375 monotherapy until disease progression,
intolerable toxicity, or termination for other reasons. The primary endpoint of the Phase II
clinical trial is to evaluate ORR. The secondary endpoints of the Phase II trial are to evaluate
(i) DoR, DCR, TTR, PFS, best overall response and OS; (ii) the incidence and severity of AEs
and SAEs; (iii) changes in laboratory tests, vital signs, and electrocardiogram; and (iv) plasma
concentrations.
The key inclusion criteria for the trial include but not limited to: (i) male or female
patients aged between 18 and 75 years; (ii) patients with a life expectancy of 12 weeks or more;
(iii) patients with histologically or cytologically confirmed advanced or metastatic solid tumors
harboring the KRAS G12D mutation; and (iv) patients with at least one measurable lesion. The
key exclusion criteria for the trial include but not limited to: (i) patients with active brain
metastases; (ii) patients with poorly controlled or severe cardiovascular disease; (iii) patients
with active hepatitis B or active hepatitis C viruses; (iv) patients with combined major acute
or chronic infectious diseases; or (v) patients who have completed palliative radiotherapy
within 14 days prior to the first dose.
Status . On February 25, 2025, the ethics committee approved our plan for a Phase II
clinical trial, which marked the initiation of the trial. The Phase II clinical trial has started
patient enrollment. We expect to complete the trial in the fourth quarter of 2028.
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Safety data of the Phase I/II trial:
As of the data cutoff date of July 17, 2025, 142 patients were enrolled, including 28
patients with NSCLC, 85 patients with PDAC and 29 patients with other solid tumors, whose
median exposure time of GFH375 was 2.2 (range: 0.2-11.3) months. The most common TRAEs
(reported in /H1135020% patients) were diarrhea, vomiting, nausea, anemia, decreased appetite,
neutrophil count decrease, white blood cell count decrease, aspartate aminotransferase
increase, asthenia, hypoalbuminemia and alanine aminotransferase increase. The TRAEs were
primarily Grade 1 or 2. TRAEs of Grade 3/4 and SAEs occurred in 27.5% (39/142) and 7.7%
(11/142) of the patients. 11 patients (7.7%) had dose reduction, and 6 patients (4.2%)
discontinued treatment due to TRAEs. No treatment-related death was recorded.
Efficacy data of the Phase I/II trial:
As of the data cutoff date of July 15, 2025, among the 16 patients treated with GFH375
at 600 mg QD, ORR was 68.8% and DCR was 93.8%.
Tumor response was observed at all dose levels. Among the 28 NSCLC patients recruited
in the study, the median follow-up time was 4.5 (range: 1.8-12.2) months, and tumor response
was observed at all dose levels. Among the 26 evaluable patients, ORR was 57.7% and DCR
was 88.5%.
GFH375X1201: A Phase II study to evaluate GFH375 in patients with KRAS G12D mutant
metastatic pancreatic cancer
Overview. This is a multicenter, open-label, Phase II study to explore the efficacy,
safety/tolerability and PK of GFH375 in patients with previously treated KRAS G12D mutant
metastatic pancreatic cancer. The primary objective is to evaluate the efficacy of GFH375 in
treating KRAS G12D mutant metastatic pancreatic cancer. The secondary objectives are to
evaluate the safety, tolerability and PK profile of GFH375 in treating KRAS G12D mutant
metastatic pancreatic cancer.
Trial Design . About 83 patients will be enrolled and treated with GFH375 administered
orally 600 mg QD for 21-day treatment cycles until disease progression, intolerable toxicity,
or termination of study treatment due to other reasons. The patients will return to the study
center about 30 days after the last treatment to complete a safety follow-up, and survival
follow-up will be conducted about every 90 days thereafter. The primary endpoint is to
evaluate ORR per RECIST 1.1 by blinded independent central review. The secondary endpoints
are to evaluate (i) ORR per RECIST 1.1 by the investigator; (ii) DoR, DCR, TTR, PFS, and
OS; (iii) the incidence and severity of AEs and SAEs; and (iv) plasma concentration of
GFH375.
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The key inclusion criteria for the trial include: (i) male or female aged between 18 and
75 years; (ii) histologically or cytologically confirmed metastatic pancreatic cancer harboring
KRAS G12D mutation; (iii) able to provide tumor tissue samples that meet the requirements;
(iv) having at least one measurable lesion according to RECIST1.1; and (v) life expectancy
above 12 weeks. The key exclusion criteria for the trial include: (i) active brain metastases; (ii)
prior treatment with a KRAS G12D inhibitor or a pan-RAS/KRAS inhibitor; (iii) with poorly
controlled or severe cardiovascular disease; (iv) with active hepatitis B or active hepatitis C;
and (v) known allergy to the study drug or its components.
Status . We plan to initiate the clinical trial in the fourth quarter of 2025.
Clinical Development Plan
GFH375X1101
We have initiated the Phase II part of the Phase I/II clinical trial in patients with advanced
solid tumors harboring the KRAS G12D mutation in China in February 2025. We expect to
submit to the NMPA a pre-pivotal study communication request in the third quarter of 2025 and
initiate a pivotal clinical study of GFH375 as a treatment of pancreatic ductal adenocarcinoma
(“PDAC ”) in the fourth quarter of 2025. We expect to submit to the NMPA an NDA for
GFH375 as a treatment of PDAC in the third quarter of 2027. In addition, we expect to submit
to the NMPA a pre-pivotal study communication request in the fourth quarter of 2025 and
initiate a pivotal clinical study of GFH375 as a treatment of NSCLC in the first quarter of 2026.
We expect to submit to the NMPA an NDA for GFH375 as a treatment of NSCLC in the third
quarter of 2027. We also expect to initiate clinical studies of GFH375 in combination with
other drugs in the fourth quarter of 2025 for previously treated CRC, and treatment-naive
PDAC and NSCLC.
GFH375X1201
We plan to initiate the clinical trial in the fourth quarter of 2025.
U.S. Phase 1/2a Study of VS-7375
V erastem has initiated a Phase I/IIa clinical trial of GFH375 in patients with advanced
solid tumors harboring the KRAS G12D mutation in the U.S. In June 2025, the first patient was
dosed in the trial.
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Licenses, Rights and Obligations
We collaborated with V erastem to facilitate the swift development and approval of
GFH375 for commercialization outsider Greater China, while we retain development and
commercialization rights within Greater China. V erastem is a U.S. based Nasdaq-listed
biopharmaceutical company committed to the development and commercialization of new
medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven
cancers. Our collaboration with V erastem leverages the latter’s expertise in conducting clinical
trials of RAS inhibitor drug candidates in the U.S. and other countries, as well as V erastem’s
successful experience in obtaining FDA approval for RAS inhibitor drugs.
On August 24, 2023, we entered into a collaboration and option agreement with V erastem,
pursuant to which, on a program-by-program basis, we granted V erastem options to acquire an
exclusive license to develop and commercialize three product candidates, including GFH375,
in territories outside of Greater China within the specified option exercise period. V erastem
agreed to pay an upfront payment in two installments, certain development costs, as well as
stipulated milestone payments, option exercise fees and royalties on future annual net sales.
GFH375 was independently discovered and developed by the Company, and V erastem was not
involved in its initial discovery or in any clinical research and development activities related
to the GFH375X1101 trial. For additional information, see “— Major Collaboration and
Licensing Arrangements — Collaboration and Option Agreement with V erastem.” In January
2025, V erastem exercised the option to acquire an exclusive license to develop and
commercialize GFH375 in territories outside of Greater China.
Material Communications with Competent Authorities
We submitted the IND application for the GFH375X1101 trial to the NMPA in March
2024. In June 2024, the NMPA issued the IND approval without material inquiries or
objections. The clinical trial protocol of GFH375X1101 communicated with the CDE of the
NMPA covers both Phase Ia/Ib and Phase II clinical trials of GFH375, and Phase Ia/Ib and
Phase II clinical trials are two separate trials with different objectives and endpoints. The
approved clinical trial protocol does not require us to communicate with the NMPA prior to the
commencement of the Phase II trial and only requires obtaining approval from the ethics
committee for the clinical trial protocol before commencing Phase II trial. In September 2024,
we amended the clinical trial protocol design to specify the BID regime that may be applied
to patients in dose exploration in Phase Ia. The starting dose of BID will be selected from one
of the five dose groups (100mg, 150mg, 200mg, 300mg, and 400mg), and the total daily dose
will be consistent with the QD dose already explored. In November 2024, we amended the
clinical trial protocol regarding Phase I, by removing the Phase Ib trial, and amending the QD
dose levels to be administered and the size of potential backfilling cohorts. On January 22,
2025, the sponsor and principal investigators of the GFH375X1101 trial had a discussion on
the Phase I clinical trial to confirm that the primary endpoints of the Phase I clinical trial had
been reached and RP2D had been decided, and therefore the Phase II clinical trial was allowed
to be initiated according to the study protocol. We thereafter amended the clinical trial protocol
in late January 2025 to provide clinical basis of the determination of the RP2D and amended
inclusion and exclusion criteria for PDAC and NSCLC patients.
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Each clinical trial protocol amendment mentioned above have been submitted to clinical
trial management system, and we have not received any objection or concerns from CDE as of
the Latest Practicable Date. Our PRC Legal Advisor has consulted with the CDE, during which
(i) the CDE confirmed that all amendments to the initial clinical trial protocol (including
removing a previously planned Phase Ib clinical trial), so long as the safety of the subjects
remains unaffected, are allowed without requiring additional approvals or review from the
CDE, (ii) the CDE did not raise any concerns or questions on our submissions regarding
amendments to clinical trial protocol via the CDE’s clinical trial management system; and (iii)
the CDE did not object that we can proceed with a Phase II clinical trial after reaching primary
endpoints in the Phase I clinical trial. According to the “umbrella” approval of the Phase I and
Phase II clinical trials of GFH375 from the NMPA and the aforementioned consultation with
the CDE, Phase I trial of the Phase I/II clinical trial of GFH375 is a standalone complete trial
equivalent to a typical Phase I clinical trial regulated by the Competent Authority.
In April 2025, the FDA granted V erastem’s IND application to conduct a Phase I/IIa
clinical trial of GFH375 in patients with advanced solid tumors harboring the KRAS G12D
mutation in the U.S.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET GFH375
SUCCESSFULLY.
Preclinical RAS-targeting Candidates
GFH276: A Pan-RAS Molecular Glue
GFH276 is our flagship product candidate exploring pan-RAS approaches. Pan-RAS
approaches, which inhibit all mutant and wild-type RAS isoforms, have theoretical advantages
over their mutant-specific counterparts. GFH276 acts as a molecular glue by forming a binary
complex with the chaperone protein CypA, which in turn associates with RAS in the “on” state,
regardless of the particular RAS variants. Formation of the tricomplex of GFH276, CypA and
RAS leads to steric occlusion and prevents the binding of downstream effector proteins to
RAS, therefore disrupting signaling pathways that drive cell growth. The following diagram
depicts the mechanism of action of GFH276.
GFH276
CypA
Inactive H/N/KRAS Active
H/N/KRAS
GTPGDP
 G
T
G
G
G
D
Tri-complex
RAF(RBD)
Steric clash
RAS
CypA
Block RAS
downstream signals
MOA of tri-complex pan-RAS(on) inhibitor
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Source: Company information
Notes: CypA: Cyclophilin A; RAF: a family of protein kinase downstream of RAS in the RAS pathway and can be
activated by binding to GTP-bound RAS; PI3K: Phosphoinositide 3-kinase, which plays a crucial role in
various cellular functions, including cell growth, proliferation and survival, and can be activated by
interacting with RAS through its RAS-binding domain.
RMC-6236, the only pan-RAS candidate with similar mechanism of action as GFH276
under Phase III clinical trial being developed worldwide, has demonstrated potentially
favorable clinical efficacy in early trials. Notably, preclinical data of GFH276 showed that its
efficacy in animals is better than that of RMC-6236, requiring only one-tenth of the dose to
achieve comparable tumor growth inhibition. The diagram below illustrates that in the AsPC-1
CDX pancreatic ductal adenocarcinoma model, GFH276 at a dose of 1 mg/kg was more
effective than RMC-6236 at a dose of 10 mg/kg.
Source: Company information
GFH276 also demonstrated potential anti-proliferative activity in cells that harbor a
single G12C mutation in KRAS or an additional KRAS mutation that can render the cells
resistant to adagrasib, suggesting the potential of GFH276 to control tumor cells growth when
acquired resistance renders approved KRAS G12C inhibitors less effective. Furthermore,
GFH276 demonstrated potential anti-proliferative activity in cells that are induced to be
resistant by sotorasib.
Effect of 2nd KRAS mutation on AP IC
50 in Ba/F3 cells lines (nM)
Ba/F3-KRAS-G12C
Ba/F3-KRAS-G12C-R68S
Ba/F3-KRAS-G12C-H95Q
Ba/F3-KRAS-G12C-Y96C
0.38 0.25 7.0
306
549
757
1.67
0.21
0.24
4.06
0.27
0.33
Cell Line GFH276 RMC-6236 Adagrasib
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AP IC 50 sotorasib-resistant NCI-H358 cell line
Compound Compound type IC 50 (nM)No.
1 GFH276 42panRAS (on) inhibitor
24 6 panRAS (on) inhibitorRMC-6236
3 4,396 SIIP-based KRAS G12C inhibitorSotorasib
4 2,177 SIIP-based KRAS G12C inhibitorAdagrasib
5 >10,000 SIIP-based KRAS G12C inhibitorDivarasib
6 >10,000Inhibitor by CypACyclosporin A
Source: Company information
Note: FGFR2-TACC2: a fusion protein of fibroblast growth factor receptor 2 and transforming acidic coiled-coil
protein-2, which appears in multiple tumor types; PBS: phosphate-buffered saline; IC 50: half maximal
inhibitory concentration, a lower concentration indicates a stronger inhibitory effect.
We believe the encouraging preclinical activities of GFH276 underscore its potential to
overcome limitations of mutant specific KRAS inhibitors and benefit a broad patient
population in need. We submitted an IND application to the NMPA for conducting a Phase I/II
clinical trial of GFH276 in June 2025.
GFS784: EGFR-Pan-RAS Functional Antibody Synergetic Conjugate
GFS784 is our leading functional antibody synergistic conjugate (“ FAScon ”) candidate.
FAScon is a class of bioconjugates featuring a combination of antibody and small molecule
drug targeting separate components of the same signaling pathway. The design of FAScon also
incorporates a highly hydrophilic linker, which is sufficiently stable to prevent premature
release of payload in the blood and enables conjugation of hydrophobic small molecules at a
high drug-to-antibody ratio. The following diagram depicts the mechanism of action of
GFS784.
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Tumor growth
EGFR
/g132Cetuximab: an approved
antibody with validated
synergy when combined
with KRAS G12C
inhibitor such as
Fulzerasib.
/g132panRAS(on) inhibitors:
more effective and more
selective in RASmut cell
lines compared with
traditional payloads such
as DXd.
reactivation
Source: Company information
GFS784 consists of an antibody that blocks EGFR, an upstream cell surface receptor of
RAS, and a small molecule pan-RAS inhibitor. We believe this design has the potential to
deliver clinical benefits, given the encouraging results of our clinical development of the
GFH925/cetuximab combination, which also targets EGFR and a RAS variant. In our
preclinical studies, GFS784 demonstrated durable antitumor activity measured by tumor
volume in mice models, as showed in the following diagram. Such antitumor activity of
GFS784 was comparable to that of an EGFR-exatecan derivatives (“ DXd”) ADC in DXd
sensitive mouse model. Dxd is a commonly deployed cytotoxic payload in ADCs. In DXd
insensitive model, while the EGFR-DXd ADC demonstrated significantly reduced antitumor
activity, GFS784 still inhibited the growth of tumor in a durable manner, underscoring that
GFS784 functions through a different mechanism from that of a typical ADC compound.
Source: Company information
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In the EGFRm KRAS wildtype H1975 NSCLC xenograft model, single dose
administration of GFS784 had demonstrated enhanced efficacy compared to EGFR-DXd ADC,
as illustrated in the following diagram, demonstrating potential in treating EGFRm NSCLC
patients.
Source: Company information
We plan to complete the preclinical study for GFS784 and file an IND application with
the NMPA in the first quarter of 2026.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET THE
ABOVE PRECLINICAL CANDIDATES SUCCESSFULLY.
OTHER PIPELINE PRODUCTS
GFH312: A Small Molecule Inhibitor of RIPK1
GFH312 is an in-house developed, potent small molecule that targets RIPK1 and inhibits
its kinase activity. Activation of RIPK1 plays significant roles in autoimmune disorders,
inflammatory conditions and neurodegeneration. We completed one Phase I clinical trial in
Australia (GFH312X3101) and one Phase I clinical trial in China (GFH312X1102), both in
healthy participants. Both clinical trials demonstrated favorable safety profiles. We have
received the IND approval from the FDA for a Phase II clinical trial to evaluate the safety and
efficacy of GFH312 for the treatment of PAD with IC. We have also received IND approval
from the NMPA for a Phase II clinical trial of GFH312 for the treatment of PBC. The results
of the Phase I clinical trial in Australia supported the Phase II IND approval in the United
States.
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Mechanism of Action
RIPK1 is a master regulator of cellular fate, balancing pro-survival nuclear factor kappa
B( “ NF-/H9260B”) signaling and cell death in response to a wide range of inflammatory processes,
apoptosis, and necroptosis in human diseases. Activation of RIPK1 kinase has been observed
in pathological samples from autoimmune, inflammatory, and neurodegenerative conditions.
Additionally, both monogenic and polygenic variants of known RIPK1 regulators contribute to
inflammatory and neurodegenerative diseases. Furthermore, RIPK1 kinase activation plays a
central role in mediating cell necroptosis following the activation of tumor necrosis factor
receptor 1 (“ TNFR1 ”) by TNF- /H9251, particularly in apoptosis-deficient conditions.
RIPK1 inhibitors downregulate RIPK1 kinase activity and effectively suppress cell death
induced by TNF- /H9251and caspase inhibitors. Inhibition of RIPK1 has demonstrated efficacy
across a wide range of human diseases, including multiple types of neurodegenerative
conditions and autoimmune diseases. GFH312 inhibits RIPK1 kinase activity, blocking cell
death and associated inflammation, making it a potent treatment for autoimmune and
inflammatory diseases.
The diagram below illustrates the mechanism of action of GFH312:
TNFa
OPTN
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
Ub
P
P
P
Ub
Ub
Ub
Ub
Ub
NEMO
IKK1/2
A20
cCLIP
FADD
RIPK1
P
P
P
RIPK1
RIPK3
FADD
Casp8
MLKL
FADD
Casp8
RIPK1
RIPK1
Casp8
TBK1
NF-kB
activation
RIPK1-
independent
apoptosis
Dimerization/
activation
Complex IIa
RIPK1-dependent
apoptosis
Complex Iib
RIPK1-dependent
necroptosis
GFH312
Active Casp8
Active Casp8
TAK1
Peli1
TAB2/3
TRAF1/2
clAP1/2 XIAP
HOIP HOIL1
SHARPIN CYLD
SPATA2
RIPK1
TRADD
TNFR1
RIPK1 kinase inhibitor
Complex I
Source: Company information
Abbreviations: Casp: Caspase; cCLIP: canonical caspase-dependent lipid-interacting protein; CLAP: caspase-like
apoptosis protein; CYLD: Cylindromatosis; FDAA: fluoromethyl ketone-modified dipeptide amino acid; HOIL: HOIP
interacting protein; HOIP: HECT domain and Ankyrin repeat containing E3 ubiquitin protein ligase; IKK: I /H9260B
kinase; NEMO: NF-kB essential modulator; OPTN: optineurin; SHARPIN: SHANK-associated Rhomain-binding
protein; SP ATA: spermatogenesis associated protein; TAB: TAK1-binding protein; TAK: transforming growth factor
beta-activated kinase; TBK1: TANK-binding kinase 1; TNF: tumor necrosis factor; TNFR: tumor necrosis factor
receptor; TRADD: TNF receptor-associated death domain protein; TRAF: TNF receptor-associated factor; Ub:
ubiquitin XIAP: X-linked inhibitor of apoptosis protein
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Market Opportunity and Competition 1
As of the Latest Practicable Date, there was no approved RIPK1 inhibitor drug globally.
There were seven RIPK1 inhibitor candidates under clinical development globally as of Latest
Practicable Date, and GFH312 was the only one developed for the treatment of PAD and PBC.
PAD is a common condition in which atherosclerosis causes narrowed arteries that reduce
blood flow to the arms or legs. Atherosclerosis, the gradual buildup of plaque inside the
arteries, is closely linked to inflammation. PAD is estimated to affect over 300 million people
worldwide, according to Frost & Sullivan. The classic symptom of PAD, IC, is characterized
by exertional leg pain that resolves with rest and is estimated to affect approximately 5.5% of
the newly diagnosed patients with PAD and 12.6% of the patients with a prior diagnosis of
PAD. Patients with PAD with IC have impaired walking ability, poor functional outcomes, and
a reduced quality of life. However, few pharmacological therapy options are available to
address the inflammatory mechanisms of PAD. According to Frost & Sullivan, global PAD
drug market grew from US$8.1 billion in 2019 to US$10.4 billion in 2024, and is expected to
further grow to US$14.0 billion in 2033. Given the observed elevation of RIPK1 expression in
human atherosclerotic lesions, RIPK1 has been viewed as a potential therapeutic target for
reducing residual inflammation in patients at high risk of developing coronary artery disease.
PBC is a chronic, slowly progressive autoimmune, cholestatic liver disease. It is
characterized by progressive inflammation and destruction of small bile ducts, resulting in
fibrosis, cirrhosis, and eventually leading to complications of end-stage liver disease and death.
The prevalence of PBC reached 1.2 million globally and 287.3 thousand in China in 2023,
according to Frost & Sullivan. As of the Latest Practicable Date, there were four drugs
approved by the FDA for the treatment of PBC. Current recommended treatments include
first-line treatment of UDCA and second-line treatment of OCA. Similarly in China, UDCA is
generally the first-line treatment option to PBC. However, approximately 40% of patients with
PBC exhibit incomplete response to UDCA, leaving considerable medical need for novel
treatments of PBC. We believe that GFH312 possesses the therapeutic potential to alleviate the
root cause of PBC.
Note
1. Market information and statistics set out in this subsection have been extracted from an report prepared by
Frost & Sullivan.
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Competitive Advantages
We believe that GFH312 has the following competitive advantages:
Demonstrated tolerability in clinical and preclinical studies
GFH312 has demonstrated potentially favorable safety profile in clinical trials. We have
completed two Phase I clinical trials in healthy participants in Australia and China. All TEAEs
reported were classified as Grade 1 or 2. There were no Grade 3 or above AEs, no SAEs or
deaths. The overall safety and tolerability of GFH312 were favorable for repeated doses of up
to 200 mg QD.
GFH312 also demonstrated a favorable safety profile in in vivo preclinical studies
involving rat and monkey models. In particular, GFH312 had no effects on either the central
nervous system or respiratory system at any dose tested in rats. Preclinical studies in monkeys
also indicated that GFH312 had no effects on cardiovascular function at tested doses.
Favorable activity in preclinical studies
The preclinical activity of GFH312 was evaluated in TNF- /H9251-induced systemic
inflammatory response syndrome and myelin oligodendrocyte glycoprotein-induced
experimental autoimmune encephalomyelitis mouse models. In the systemic inflammatory
response model, a single oral dose of GFH312 increased the survival rate in a dose-dependent
manner. In the experimental autoimmune encephalomyelitis mouse model, orally administered
GFH312 at doses of 1 mg/kg and 3 mg/kg, twice daily, attenuated the development of
experimental autoimmune encephalomyelitis, resulting in significant reductions in clinical
scores, protection against body weight loss, and reductions in inflammatory infiltration and
demyelination, in a dose-dependent manner.
Potentially promising PK/PD profile
The Phase I clinical trial of GFH312 (GFH312X3101) conducted on healthy participants
in Australia revealed a potentially promising PK/PD profile. In participants receiving a single
ascending dose (“ SAD”) of GFH312, the mean plasma concentration of GFH312 increased
with the dose level, and exposures (AUC
0-t and C max) increased with increasing dose over the
5 mg to 360 mg range. In participants receiving multiple ascending dose (“ MAD”) treatment,
plasma concentration approached steady-state approximately seven days after administration.
The GFH312 CSF concentration following a 100 mg single dose was approximately fourfold
higher than the half maximal inhibitory concentration of human monocyte-derived
macrophages necroptosis with expected central nervous system penetration. All dose levels of
GFH312 in both SAD and MAD treatments resulted in a rapid decrease of phospho-RIPK1
levels from baseline. This decrease was sustained for 24 hours post-dose for SAD and from day
1 to day 14 for MAD. The PD results indicate that GFH312 at a dose level as low as 5 mg is
sufficient to produce an effective and sustained inhibition of phospho-RIPK1.
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Summary of Clinical Trials
As of the Latest Practicable Date, we had completed one Phase I clinical trial in Australia
(GFH312X3101) and one Phase I clinical trial in China (GFH312X1102). We have also
received the IND approval from the FDA for a Phase II clinical trial to evaluate the safety and
efficacy of GFH312 for the treatment of PAD with IC. The results of the Phase I clinical trial
in Australia supported the Phase II IND approval in the United States and were the only clinical
results that we submitted for the consideration by the FDA. The following table sets forth an
overview of the completed clinical trials of GFH312:
Study Number Phase Study Design Sites Subjects Status
Planned/
Actual
Patient
Enrollment
GFH312X3101 /H1118/H1118I Evaluate safety,
tolerability and PK
of single- and
multiple-ascending
doses and food effect
of GFH312
Australia Healthy
participants
Completed Planned: 88;
Actual: 76
GFH312X1102 /H1118/H1118I Evaluate PK profile
and safety of
GFH312 after single
and multiple
administrations
Mainland
China
Healthy
participants
Completed Planned: 26;
Actual: 26
Scope of the IND Approval/Registration. The Phase I clinical trial of GFH312 in healthy
participants in Australia was registered with the TGA in February 2021. The Phase II clinical
trial of GFH312 in patients with PAD and IC in the United States was approved by the FDA
in August 2022. The Phase I clinical trial of GFH312 for potential treatment of rheumatoid
arthritis in healthy subjects in China was approved by the NMPA in September 2022. The Phase
II clinical trial of GFH312 in PBC was approved by the NMPA in May 2025. The IND approval
and the approved trial protocol did not specify the intended line of treatment. No head-to-head
comparison is required or planned prior to the pivotal trial.
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The following sets forth an overview of the key clinical trial of GFH312:
GFH312X3101: A Phase I first-in-human, randomized, double blinded, placebo-controlled,
two-part study to assess safety/tolerability and PK of single- and multiple-ascending doses and
food effect of GFH312 in healthy participants in Australia sponsored by us
Overview. This trial is a first-in-human, randomized, double-blinded, placebo-controlled
Phase I clinical trial to evaluate safety, tolerability and PK of SAD and MAD and food effect
of GFH312 in healthy participants. The primary objective is to evaluate the safety, tolerability
of single (administered under fed and fasted conditions) and repeat doses of GFH312 in healthy
participants. The secondary objective is to characterize the PK profile of single and repeat
doses of GFH312 in healthy participants.
Trial design. The trial was divided into two parts: an SAD (Part Ia) with an additional
food effect cohort (Part Ib), and an MAD (Part II). In Part I, 52 participants were randomized
and dosed, with 38 receiving GFH312 treatment and 14 receiving placebo treatment. Each dose
level of GFH312 included six participants at 5 mg, 15 mg, 45 mg, and 200 mg; five participants
at the 100 mg fasting and 360 mg dose levels; and four participants at the 500 mg dose level.
For the fed treatment, six participants received the 100 mg dose of GFH312. In Part II, 24
participants were dosed, with 19 receiving GFH312 treatment and five receiving placebo
treatment. This part included six participants at the 60 mg QD and 200 mg QD dose levels, and
seven participants at the 120 mg QD dose level.
Subjects in Part Ia had a duration of treatment of up to 62 days and a follow-up visit at
Day 31 (±3 days). Subjects in Part Ib had a duration of treatment of up to 96 days across 2
periods, with an intervening washout period of /H113507 days. Part Ib subjects completed all of the
study periods for Part 1a (up to 62 days), followed by a washout period of /H113507 days, and then
up to an additional 34 days composed of a baseline visit at Day -1, 4 days of assessment during
the treatment period, a study completion visit at Day 8 (±1 days), and a follow-up visit at Day
31 (±3 days). Subjects in Part II had a duration of treatment of up to 75 days, a study
completion visit at Day 21 (±1 days), and a follow-up visit at 30 days after the last treatment
(±3 days).
The primary endpoints were to evaluate incidence of AEs and SAEs, and change in
laboratory values, electrocardiogram, vital signs, and physical examinations. For the single
doses of GFH312, the secondary endpoints were to evaluate (i) plasma concentration of
GFH312 and derived PK parameters, and (ii) cerebrospinal fluid concentration and
cerebrospinal fluid/plasma ratio of GFH312 in one cohort. For the repeat doses of GFH312, the
secondary endpoints were to evaluate (i) plasma concentration of GFH312 and derived PK
parameters, and (ii) cerebrospinal fluid concentration and cerebrospinal fluid/plasma ratio of
GFH312 following repeat doses in one cohort.
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The key inclusion criteria for the trial include but not limited to: (i) healthy male and
female participants aged between 18 and 55 years; (ii) participants with sitting vital signs
within the normal ranges; and (iii) participants weighing at least 50 kg, with a body mass index
within the range of 18-32kg/m
2 inclusive. The key exclusion criteria for the trial include but
not limited to: (i) participants with clinically significant electrocardiograph abnormalities; (ii)
participants with immunodeficiency diseases; (iii) participants with chronic infection with
hepatitis B or hepatitis C viruses; (iv) participants with significant cardiovascular, respiratory,
renal or neurological diseases; or (v) participants with recent (within the last three years)
and/or recurrent autonomic dysfunction.
Status. The trial was initiated in April 2021, and completed in October 2022 in Australia.
The trial enrolled 76 participants.
Safety Data. In the SAD cohorts, the incidence of TEAEs was 42.1% (16 out of 38) among
participants receiving GFH312 (0 in the 100mg GFH312 treatment (fed) cohorts; 33.3% in the
5mg, 45mg, 200mg GFH312 treatment (fasting) cohorts; 40.0 % in the 360mg GFH312
treatment (fasting) cohort, 50% in the 15mg and 500mg GFH312 treatment (fasting) cohorts,
and 60% in the 100mg GFH312 treatment (fasting) cohort), and 42.9% (6 out of 14) in the
participants receiving placebo. TRAEs were reported in two participants receiving GFH312
(5.3%) and two participants receiving placebo (14.3%). The TEAEs reported in at least 5% of
the overall participants included headache (7.9% of GFH312 vs. 7.1% of placebo), procedural
pain (7.9% of GFH312 vs. 7.1% of placebo), and muscle twitching (5.3% of GFH312 vs. 7.1%
of placebo). The TRAEs reported were one headache and one muscle twitching in the GFH312
treatment cohorts, and one muscle twitching and one diarrhea in the placebo treatment cohorts.
All TEAEs and TRAEs were Grade 1 according to CTCAE v5.0.
In the MAD cohorts, the incidence of TEAEs was 63.2% (12 out of 19) among
participants receiving GFH312 (66.7% in the 60mg GFH312 treatment cohort, 71.4% in 120mg
treatment cohort and 50.0% in the 200mg GFH312 treatment cohort), and 40.0% (2 out of 5)
of participants receiving placebo. TRAEs were reported in 21.1% (4 out of 19) of participants
receiving GFH312 (14.3% and 50.0% in the 120mg and 200mg GFH312 treatment cohorts,
respectively), and 20.0% (1 out of 5) of participants receiving placebo. The TEAEs reported
in at least 10% of the overall participants included headache, post-procedural complication,
procedural pain, back pain and nausea. Most TEAEs were Grade 1 according to CTCAE v5.0,
except for three Grade 2 events (positional vertigo in the 60mg GFH312 treatment cohort, back
pain in the 120mg GFH312 treatment cohort, and increased blood creatinine in the 200mg
GFH312 treatment cohort). The TRAEs reported among participants receiving GFH312
included three patients with headache (Grade 1) and one patient with increased blood
creatinine (Grade 2, recovered to normal condition at the end of treatment visit). No Grade 3
or above AEs were reported, and there were no SAEs or deaths. Three participants discontinued
the treatment early due to TEAEs in MAD cohorts: two participants (10.5%) in the GFH312
treatment cohorts and one participant (20.0%) in the placebo treatment cohort. One participant
in the 200mg GFH312 MAD treatment cohort discontinued the treatment early due to increased
blood creatinine (Grade 2), which was related to GFH312. All TEAEs were not significantly
associated with any specific system organ classes or dose levels.
The results demonstrated that GFH312 was safe and well tolerated in healthy participants.
A favorable safety profile was observed with the 120 mg once-daily dose of GFH312 treatment.
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GFH312X1102: A Phase I clinical trial to evaluate safety and PK profile of GFH312 after
single and multiple administrations in healthy participants in Mainland China sponsored by us
Overview. This trial is a randomized, double-blind, placebo-controlled, parallel-group,
single-dose and multiple-dose Phase I clinical trial to evaluate safety and PK profile of
GFH312 in healthy participants. The primary objective is to evaluate PK profile of GFH312
after single and multiple administrations in healthy participants. The secondary objectives are
to evaluate safety of GFH312 after single and multiple administrations in healthy participants.
Trial design. A total of 26 participants are randomized and treated orally with GFH312 or
placebo once daily for 14 days in three cohorts: 100 mg GFH312 in the single-dose cohort, 200
mg GFH312 in the single-dose cohort, and 120 mg GFH312 in the multiple-dose cohort. In
each single-dose cohort, eight healthy participants are randomly assigned to receive either
GFH312 or placebo in a 3:1 (GFH312: placebo) ratio. The multiple-dose group includes 10
healthy participants who are randomly assigned to receive either GFH312 or placebo in a 4:1
(GFH312: placebo) ratio. The primary endpoints are to evaluate blood concentration and PK
profile of GFH312. The secondary endpoints are to evaluate incidence and percentage of AE
and SAEs, and change from baseline in physical examination, vital signs, 12-lead
electrocardiograph, and laboratory tests.
The key inclusion criteria for the trial include but not limited to: (i) healthy male or
female participants aged between 18 and 55 years; (ii) participants with a body mass index
between 18-28 kg/m
2 (inclusive), and weight of at least 50kg; and (iii) participants with normal
examination results or with abnormal examination results that are not clinically significant
during the screening period and on Day-1. The key exclusion criteria for the trial include but
not limited to: (i) participants with abnormal electrocardiogram with clinical significance; (ii)
participants with immunodeficiency diseases, including a positive human immunodeficiency
virus antibody test; (iii) participants with significant cardiovascular, respiratory or
neurological diseases; (iv) participants with any type of malignant tumor within the last five
years; or (v) participants with major diseases that have not been recovered within two weeks
prior to initiation of dosing.
Status. The trial was initiated in December 2022 and completed in February 2023 in
Mainland China.
Safety Data. A total of 10 subjects (38.5%) experienced 16 TRAEs. In the single-dose
cohort, TRAEs were reported in three (25%) participants receiving GFH312 and two (50%)
participants receiving placebo. In the multiple-dose cohort, TRAEs occurred in five (62.5%)
participants receiving GFH312, with no participants receiving placebo reported. The most
common TRAE was an elevation in blood triglyceride, occurred in one (8.3%) participant
receiving GFH312 and one (25%) participant receiving placebo in the single-dose group, as
well as in only one (12.5%) participant receiving GFH312 in the multiple-dose group. All
TRAEs were Grade 1 in severity. No dose-related trends were observed in laboratory findings,
vital signs, weight, physical examinations, and electrocardiography, or differences in changes
associated with GFH312 or placebo administration. In summary, the overall safety and
tolerability of GFH312 were favorable for single doses of 100 mg or 200 mg and multiple
repeated doses of 120 mg.
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GFH312X1102: A Phase II clinical trial to evaluate the safety and efficacy of GFH312 in
patients with PBC who have an inadequate response to UDCA in Mainland China sponsored
by us
Overview. This is a randomized, double-blind, placebo-controlled, dose-finding Phase II
clinical study to evaluate the safety and efficacy of GFH312 in patients with PBC who have
an inadequate response to UDCA. The primary objective is to evaluate the efficacy, safety and
tolerability of GFH312 in the PBC patients. The second objectives are to evaluate the PK
profile of GFH312 and the changes of the following parameters in the PBC patients including
liver function, metabolism, itching, total bile acid, inflammation, and metabolic bone disease.
Trial Design . About 100 patients will be randomized and treated orally with GFH312 or
placebo once daily for 12 weeks in four cohorts: placebo cohort; 40 mg GFH312; 80 mg
GFH312; 120 mg GFH312. The primary endpoints are to evaluate the percentage change of
alkaline phosphatase (“ ALP”) from baseline, the AEs, and the change from baseline in physical
examination, vital signs, 12-lead electrocardiograph, and laboratory tests. The secondary
endpoints include plasma concentration and PK profile of GFH312, change from baseline in
total bile acid and inflammatory factors.
The key inclusion criteria for the trial include: (i) male or female aged between 18 and
75 years; (ii) meeting the diagnostic criteria for PBC, which means meeting at least two of the
following three items: (1) indicators reflecting cholestasis such as elevated ALP , (2) positive
in anti-mitochondrial antibodies (“ AMA”) or AMA-M2, or if AMA is negative, positive in
PBC-specific antibodies such anti-gp210 antibody or anti-Sp100 antibody, (3) liver biopsy
being consistent with PBC; and (iii) patients who had taken UDCA for at least 6 months before
enrollment (stable dose of UDCA at no less than 13-15 mg/kg/d for at least 3 months) but had
poor treatment outcome. The key exclusion criteria for the trial include: (i) having the
following diseases: Active hepatitis B virus or active hepatitis C virus infection, primary
sclerosing cholangitis, complete biliary obstruction, acute cholecystitis or gallstones with
obvious symptoms (such as biliary colic), alcoholic hepatitis, non-alcoholic steatohepatitis,
suspected or confirmed primary liver cancer, bile duct cancer; (ii) ALB lower than 3.5g/dL;
(iii) platelet level lower than 100*10
9/L; and (iv) poor blood sugar control, i.e. , glycosylated
hemoglobin higher than 9.0% at screening.
Status . We plan to initiate the clinical trial in the first half of 2026.
Clinical Development Plan
Other than the GFH312X3101 study, we have no plans for subsequent clinical trials in
Australia. The decision to conduct the Phase I trial in Australia was driven by cost-efficiency
considerations and the opportunity to collect data from patients of diverse populations.
Conducting Phase I trials in Australia is a common practice, as Australia is recognized for its
high-quality clinical trial infrastructure, particularly for non-cancer treatments. We choose to
conduct clinical trials of GFH312 in China as a treatment of PBC and in the U.S. as a treatment
of PAD with IC for the following reasons. The recruitment of PAD patients is more feasible in
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the U.S., where patients are more likely to seek treatment earlier in the disease progression. In
contrast, patients in China often delay in seeking treatment until the late stages of the
condition. According to Frost & Sullivan, PAD with IC is more widely recognized in the U.S.
We are currently evaluating the competitive landscape across various markets, recognizing that
different regions have distinct patient profiles and prevalence rates for specific indications.
Additionally, we are collecting clinical data from diverse patient populations.
We have received the IND approval from the FDA for a Phase II clinical trial of GFH312
(GFH312X2201). The Phase II clinical trial is designed as a multicenter, double-blinded,
randomized, placebo-controlled Phase II clinical trial to evaluate safety and efficacy of
GFH312 after multiple oral doses in patients with PAD with IC. We anticipate enrolling
approximately 100 patients, who will be randomized in a 1:1:1:1 ratio into four groups to
receive oral doses of 40mg, 80mg, 120mg of GFH312, along with a placebo once daily for 12
weeks, on top of standard treatment of PAD. The proposed dose levels of GFH312 were
determined based on the results from the first-in-human trial GFH312X3101 completed in
Australia. The primary endpoints will include evaluating (i) absolute change from baseline in
maximum walking distance at Week 12, assessed by a 6-minute walking test; (ii) incidence and
severity of AEs and SAEs; and (iii) changes in laboratory parameters, vital signs, and
electrocardiogram. As of the Latest Practicable Date, we have not commenced the Phase II
clinical trial in the U.S., in light of ongoing internal assessments regarding the commercial
viability of advancing GFH312 in the U.S. market and overall budgeting considerations.
In addition, we have submitted an IND application for a Phase II clinical trial of GFH312
for the treatment of PBC to the NMPA in March 2025 and obtained NMPA’s approval in May
2025. We plan to initiate the clinical trial in the first half of 2026. In light of the potential of
GFH312 in targeting inflammation, we believe GFH312 may be a promising therapeutic option
for PBC, which is a chronic, slowly progressive autoimmune, cholestatic liver disease
characterized by progressive inflammation and destruction of small bile ducts.
Material Communications with Competent Authorities
In February 2021, we registered the study protocol for GFH312X3101 with the
Therapeutic Goods Administration (the “ TGA”) of Australia. In July 2022, we submitted an
IND application including results of the Phase I clinical trial in Australia to the FDA for a
Phase II clinical trial of GFH312 in patients with PAD with IC.
The results of the Phase I clinical trial in Australia were the only clinical results that we
submitted to the FDA in the Phase II IND application dossier. Other than the clinical results,
the FDA did not request additional information from the Company for the IND approval. The
FDA (1) reviewed and took into account our IND application dossier, which included the
design and results of the Phase I clinical trial primarily concerning the safety of GFH312
administration in human conducted in Australia, (2) specifically stated that they completed
their safety review of our application dossier (as explained in (1) above), and (3) concluded
that we may proceed with our proposed Phase II clinical trial. In a “study may proceed” letter
issued in August 2022, the FDA did not raise any inquiries or objections to the safety data
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derived from our Phase I clinical trial in Australia, which by that time were the first-in-human
and only-in-human clinical data on GFH312, or require us to conduct any additional Phase I
clinical trial or safety assessment before commencing the proposed Phase II clinical trial in the
United States.
The “study may proceed” letter is equivalent to a conventional IND application approval
obtained from the FDA, as the letter allowed the applicant to conduct a Phase II clinical trial
of a study drug based on the results obtained from the Phase I clinical trial of the same study
drug. Here, the letter was based on our IND application, which incorporated primary clinical
results obtained in the Phase I clinical trial of GFH312 in Australia. By August 2022, we had
obtained the primary clinical results of the Phase I clinical trial in Australia. Since then and
until October 2022, the trial was in the close-out process. In October 2022, we obtained the
final clinical study report for the Phase I clinical trial in Australia, which we considered as
marking the final completion of the trial. The clinical results in the final clinical study report
had no substantial changes from those submitted to the FDA previously for the IND
application. Because we had obtained all the primary clinical results of the Phase I clinical
trial, the FDA granted our application for a Phase II clinical trial. The fact that the FDA
completed the safety review of the Phase II IND application materials, including the only
in-human safety results from the Australian Phase I clinical trial, did not raise any objections,
and allowed us to proceed directly to the Phase II clinical trial in the United States, indicates
that the FDA acknowledged and accepted the results of the Australian Phase I clinical trial. The
IND approval from the FDA demonstrates that the Phase I clinical trial data in Australia has
been reviewed, accepted and regarded as comparable to the completion of a Phase I clinical
trial by the FDA.
In July 2022, the NMPA accepted our IND application for GFH312 in China. The NMPA
subsequently issued IND approval in September 2022. We have completed a Phase I clinical
trial in healthy participants in China to evaluate the safety and PK profile of GFH312. In
November 2024, we had a pre-IND communication with the CDE to propose selecting PBC as
the targeted indication for the clinical trial of GFH312, which the CDE agreed. At the request
of NMPA, in March 2025, we submitted an IND application for a Phase II clinical trial of
GFH312 as a potential treatment of PBC, leveraging the results of the two Phase I clinical trials
in China and Australia for GFH312 on healthy participants. In May 2025, NMPA approved the
IND application.
We had not received any relevant regulatory agency’s objections to our clinical
development plans as of the Latest Practicable Date.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET GFH312
SUCCESSFULLY.
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GFS202A: A Novel Bispecific Antibody Targeting GDF15 and IL-6 as a Potential
Treatment of Cachexia
GFS202A is a novel bispecific antibody targeting both GDF15 and IL-6. Both GDF15 and
IL-6 are important cytokines that play crucial roles in inflammatory processes, metabolic
regulation, cancer progression and cachexia.
Cachexia is a common, life-threatening wasting condition that can significantly impact
quality of life in affected patients with cancer or other types of chronic diseases. More than
50% of patients with malignant tumors experience cancer cachexia, characterized by decreased
appetite and accelerated catabolism of muscle and adipose tissue during tumor progression,
resulting in significant weight loss. These debilitating symptoms not only impact patient
tolerability to treatment but also significantly deteriorate their quality of life, with
approximately 30% of cancer related death linked to cancer cachexia. As of the Latest
Practicable Date, there had been no FDA- or NMPA-approved drug specifically for the
treatment of cachexia, according to Frost & Sullivan. Progesterone and glucocorticoids are the
main drugs used to alleviate the symptoms of cachexia in clinical practice; however, they
demonstrate moderate efficacy accompanied by many adverse drug reactions.
GDF15, a member of the TGF- /H9252superfamily, is associated with many diseases including
cancer, inflammation and cardiovascular diseases. Targeting GDF15 for the treatment of cancer
cachexia has been demonstrated as a promising approach, as reflected in the recently
announced Phase II results of ponsegromab, a GDF15 antibody under development by Pfizer,
in improving body weight, appetite, physical activity and muscle mass in cancer patients. As
of the Latest Practicable Date, the FDA has granted Pfizer approval to initiate a Phase IIb/III
clinical trial targeting cachexia in patients with pancreatic cancer. Combined with the RAS
pathway products, our pipeline reflects broader therapeutic coverage of oncology, especially in
GI indications such as pancreatic cancer and coloractal cancers that are highly across with
cechaxia.
The diagram below illustrates the mechanism of action of GFS202A:
Source: Company information
Abbreviations: GFRAL: glial cell line-derived neurotrophic factor family receptor alpha-like; gp130: glycoprotein
130; JAK: Janus kinase; PLC: phospholipase C; RET: rearranged during transfection
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A synergistic effect exists between the GFD15 signaling pathway and the IL-6 signaling
pathway. The GDF15-GFRAL pathway is associated with the cachexia development, and high
levels of GDF-15 are negatively correlated with body weight, adiposity, physical performance,
appetite, and survival of patients. Similarly, IL-6 also acts on IL-6R on neurons to induce
cachexia. Additionally, the expression of IL-6R on these neurons overlaps with GFRAL
expression, and inhibition of IL-6R expression affects the proportion of GFRAL-positive
neurons. In light of the interactions between GDF15 and IL-6, we believe a dual neutralization
of GDF15 and IL-6 may potentially achieve a better activity compared to targeting GDF15
alone. GFS202A potently neutralizes GDF15-induced and IL-6-induced receptor activation in
cell lines.
In multiple preclinical pharmacologic models, once-weekly administration of GFS202A
at doses as low as 1.5-4 mg/kg has shown significant improvement in cachexia with weight
loss. In a repeated-dose toxicology study in cynomolgus monkeys, GFS202A was well
tolerated at doses ranging from 20 to 300 mg/kg. Additionally, in the HT-1080 human
fibrosarcoma induced cachectic mice model, mice were treated 1 mg/kg to 12 mg/kg GFS202A,
12 mg/kg isotype control and 3.3 mg/kg PF0694860 as a positive control, which was equimolar
to 4 mg/kg of GFS202A. The following figure shows that mice treated with isotype control
experienced remarkable weight loss due to fibrosarcoma induced cachexia, but the
administration of GFS202A reversed body weight loss in a dose-dependent manner.
Efficacy in HT-1080 tumor induced cachexia model
Similar results were observed in preclinical TOV21G human ovarian cancer induced
cachectic mice. The following chart shows that mice treated with weekly GFS202A
experienced a dose-dependent reversal of lean body mass loss compared to isotype control
group. The average lean body mass in the 12 mg/kg GFS202A treatment group was even higher
than that of non-tumor bearing healthy individuals. Additionally, C-reactive protein levels,
which indicate inflammation, significantly decreased after GFS202A treatment, but remained
high in the isotype control treated mice.
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Efficacy in TOV21G tumor
induced cachexia model
C-reactive protein concentration in
TOV21G induced cachexia model
Non-tumor bearing
Non-tumor bearing
Scope of IND Approval . Phase I clinical trial of GFS202A cancer patients with
pre-cachexia and cachexia in China was filed with the NMPA in Decemebr 2024 and granted
by the NMPA in March 2025. The IND approval and the approved trial protocol did not specify
the intended line of treatment. No head-to-head comparison is required or planned prior to the
pivotal trial.
As of the Latest Practicable Date, our Phase I clinical trial for GFS202A monotherapy for
the treatment of pre-cachexia and cachexia was ongoing. We believe that GFS202A represents
a potent treatment of cachexia and has the potential to capture a substantial market share.
GFS202AX1101: A Phase I study to evaluate GFS202A in advanced solid tumor patients with
pre-cachexia or cachexia in Mainland China sponsored by us
Overview. This is an open-label, multi-center, Phase I study to evaluate the
safety/tolerability and pharmacokinetics of GFS202A in advanced solid tumor patients with
pre-cachexia or cachexia. The primary objective is to assess the safety/tolerability of
GFS202A, determine its MTD and/or RP2D. Additionally, the study will assess GFS202A ’s
pharmacokinetic profile, and its impact on improving body weight and appetite.
Trial Design . Up to 36 participants will receive GFS202A intravenously every 3 weeks
(“Q3W”) in a 21-day cycle. The treatment duration will be 12 weeks. Participants will be
enrolled in different dose groups with increasing order, starting at 5 mg Q3W. Six dose levels
are planned for evaluation, including 5 mg Q3W, 25 mg Q3W, 100 mg Q3W, 200 mg Q3W, 400
mg Q3W, and 600 mg Q3W. The primary endpoints will be the incidence and severity of
AEs/SAEs and the incidence DLTs. The secondary endpoints will include but not limited to the
plasma concentration and PK profile of GFS202A, the incidence and percentage of participants
with anti-drug antibodies, change of the concentration of GDF-15 and IL-6, and change from
baseline in body weight.
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The key inclusion criteria for the trial will include: (1) men or women between the ages
of 18 and 80 years; (2) patients with histologically or cytologically confirmed solid tumors; (3)
pre-cachectic and cachectic patients with weight loss or baseline body mass index below 21
kg/m
2 within 6 months before the first study dose; (4) persistent concomitant appetite/eating
problems related to cancer; (5) adequate organ function; and (6) the expected survival time
judged by the investigator to be over three months. The key exclusion criteria for the trial will
include: (1) with active brain metastases; (2) with other active diseases that lead to reduced
food intake or seriously affect digestion and absorption baseline body mass index above 28
kg/m
2; (3) with infectious diseases; (4) with clinically significant cardiovascular disease; (5)
with uncontrolled metabolic diseases; (6) with known clinically significant allergic reactions
to antibodies and excipients; and (7) with history of drug or alcohol abuse.
Status . The trial was initiated in April 2025. We expect to complete the trial in the second
half of 2026.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET GFS202A
SUCCESSFULLY.
GFH009: A Small Molecule Inhibitor of CDK9 as a Potential Treatment of Cancer
Overview
GFH009 is a selective small molecule compound that targets CDK9 and inhibits the
activity of the CDK9/cyclin T1 complex. CDK9, a serine/threonine kinase, plays crucial roles
in tumor growth. GFH009 is designed as a potential treatment for multiple types of
hematological malignancies. It received from the FDA the orphan drug designation (“ ODD”)
and the fast track designation (“ FTD”) in October 2023 and January 2024, respectively, for the
treatment of acute myeloid leukemia (“ AML”).
Mechanism of Action
CDKs are serine/threonine kinases that regulate cell proliferation, differentiation, and
apoptosis. As a transcriptional regulator, CDK9 plays crucial roles in tumor growth. CDK9,
when associated with cyclin T, forms the positive transcription elongation factor b (“ P-TEFb ”)
complex. This complex regulates gene transcription elongation and mRNA maturation of super
enhancer-regulated genes, including the myelocytomatosis oncogene (“ MYC”) (a proto-
oncogene involved in cell growth and cell-cycle progression) and myeloid cell leukemia 1
(“MCL1 ”) (an anti-apoptosis gene). Together, these genes modulate proliferation and survival
of cancer cells. Notably, deregulation in the CDK9-related pathway has been reported in
several human malignancies, such as lymphomas, leukemia, neuroblastoma, primary
neuroectodermal tumors, rhabdomyosarcoma, and prostate cancer. These findings suggest that
CDK9 could be a promising therapeutic target for cancer therapy.
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GFH009 is a small molecule compound that targets CDK9 and inhibits the activity of the
CDK9/cyclin T1 complex with a nanomolar-level biochemical half maximal inhibitory
concentration. Therefore, treatment with GFH009 can lead to decreased protein levels of
MCL1 and c-Myc and induction of apoptosis in tumor cells and reduced tumor growth.
GFH009X2101: A Phase I clinical trial to evaluate safety and efficacy of GFH009
monotherapy in Mainland China and the United States
Overview. This is a multi-regional, non-randomized, open-label, single-arm Phase I trial.
This is an open-label trial of GFH009 monotherapy for the treatment of
relapsed/refractory hematologic tumors. The primary objectives are to evaluate safety and
tolerability of GFH009 in patients with relapsed/refractory hematologic tumors, including
AML, CLL/SLL, and lymphoma; and to determine the MTD and RP2D of GFH009. The
primary endpoints of this trial are to (i) evaluate incidence of DLT, incidence and severity of
all AEs and SAEs, and changes in laboratory indices, vital signs, physical examination, and
electrocardiogram; and (ii) dose interruptions and reductions due to toxicity.
We sponsored and were initially solely responsible for the Phase I clinical trial. The Phase
I clinical trial of GFH009 in patients with recurrent or refractory hematologic tumors was
approved by the NMPA in China in December 2020 and by the FDA in the United States in June
2020. The IND approval and the approved trial protocol did not specify the intended line of
treatment. No head-to-head comparison is required or planned prior to the pivotal trial. The
Phase I clinical trial was initiated in November 2020 in the United States and April 2021 in
China. Following our entry into a license agreement (the “ SELLAS License Agreement ”) with
SELLAS in March 2022, SELLAS became responsible for clinical development of GFH009 in
territories outside of Greater China. We completed the Phase I trial in China in April 2024.
The key inclusion criteria for the trial include but not limited to: (i) male or female
patients aged 18 or older; (ii) patients with cytologically or histologically confirmed recurrent
or refractory hematologic neoplasms (AML, CLL/SLL, and lymphomas); (iii) patients with
serum creatinine clearance higher than 60 mL/min; and (iv) patients whose electrolyte and uric
acid levels have stabilized for at least 3 days (allowing for interventional therapy) prior to the
first treatment with GFH009. The key exclusion criteria for the trial include but not limited to:
(i) patients with bulky disease ( /H1135010 cm) who require cytoreductive therapy; (ii) patients who
received a large radiotherapy within 28 days prior to the first dose of study drug or palliative
localized radiotherapy within the previous 7 days; (iii) patients with symptomatic central
nervous system metastases or primary lymphoma, molluscum contagiosum, or spinal cord
compression; (iv) patient with serious cardiovascular disease within 6 months prior to study
entry; or (v) patient with active hepatitis B virus or hepatitis C virus infection or history of
human immunodeficiency virus infection or human immunodeficiency virus-positive at
screening.
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A total of 86 patients, among which 34 had AML and 52 had lymphoma were enrolled in
the Phase I clinical trial. The enrolled patients were heavily pretreated and resistant to multiple
prior therapies.
Safety Data. The trial includes two disease cohorts: Cohort 1 enrolls 34 AML patients,
and Cohort 2 enrolls 52 lymphoma patients. In the AML cohort, 34 patients received at least
one dose of GFH009, at dosages of 9 mg BIW, 15 mg BIW, 22.5 mg BIW, 30 mg BIW, 40 mg
BIW, as well as 30 mg QW, 45 mg QW, and 60 mg QW. No DLT was observed in the dose
groups, and MTD was not achieved. All AML patients experienced at least one TEAE, with
76.5% of patients (26/34) experiencing at least one Grade 3 or higher TEAE. 64.7% (22/34) of
patients had at least one TRAE, of which 41.2% (14/34) had at least one Grade 3 or higher
TRAE. 35.3% (12/34) of patients had an SAE, with 14.7% (5/34) having a drug-related SAE.
The most common TRAEs included decreased platelet count (32.4%, 11/34), decreased white
blood cell count (26.5%, 9/34), anemia (26.5%, 9/34), decreased neutrophil count (23.5%,
8/34), nausea (17.6%, 6/34), vomiting (17.6%, 6/34), pyrexia (17.6%, 6/34), hypoproteinemia
(17.6%, 6/34) and hyperchloremia (14.7, 5/34). Additionally, in the lymphoma cohort, 52
patients received at least one dose of GFH009, at dosages of 2.5 mg BIW, 4.5 mg BIW, 9 mg
BIW, 15 mg BIW, 22.5 mg BIW, 30 mg BIW, 30 mg QW, 45 mg QW, 60 mg QW, 75 mg QW,
and 100 mg QW. 98.1% (51/52) of lymphoma patients had at least one TEAE, of which 51.9%
(27/52) experienced a Grade 3 or higher TEAE. 84.6% (44/52) patients experienced at least one
TRAE, with 38.5% (20/52) having Grade 3 or higher TRAE. 28.8% (15/52) patients had an
SAE, of which 19.2% (10/52) were drug-related SAE. The most common TRAEs included
decreased white blood cell count (48.1%, 25/52), decreased neutrophil count (42.3%, 22/52),
anemia (40.4%, 21/52), decreased platelet count (34.6%, 18/52), hyperuricemia (17.3%, 9/52),
hypokalemia (17.3%, 9/52), aspartate aminotransferase increased (13.5%, 7/52) and bilirubin
increased (11.5%, 7/52). For both AML and lymphoma patients, GFH009 did not significantly
affect other tests in terms of laboratory tests, except for the decrease in various types of cells
in routine blood tests. No significant effect on ECG was observed after GFH009
administration. The RP2D of GFH009 monotherapy was 60 mg QW for the treatment of AML
and 100 mg QW for the treatment of lymphoma.
Efficacy Data. Response was observed across dose levels in both AML cohort and the
lymphoma cohort. In the AML cohort, one patient achieved complete remission, with a
complete remission rate of 2.9% (90% CI: 0.15% to 13.21%). The duration of sustained
remission for this patient was 36.3 weeks. The median PFS was 4.3 weeks (80% CI: 4.29 to
4.57 weeks). In the lymphoma cohort, the best overall response was PR in five patients, and
nine patients had stable disease, resulting in an ORR of 9.8% based on 51 patients with target
lesion at baseline (90% CI: 3.94% to 19.52%). The median DoR was 12.2 weeks (80% CI: 5.29
weeks to NA). The median PFS was 8.3 weeks (80% CI: 8.14 to 8.43 weeks).
A study of GFH009 in combination with other drugs for the treatment of AML in the U.S.
is ongoing. The FDA granted ODD and FTD to GFH009 for the treatment of AML.
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Clinical Development Plan
We completed the GFH009 Phase I China Trial in April 2024. We had also previously
conducted clinical trials to explore the potential application of GFH009 in the treatment of
relapsed or refractory PTCL as a monotherapy and for DLBCL as a combination therapy with
zanubrutinib (such trials, the “ GFH009 Non-AML China Trials ”). As of the Latest Practicable
Date, we had strategically decided to focus on AML for GFH009 and therefore not push
forward the GFH009 Non-AML China Trials at the moment. With respect to the GFH009
development for treatment of AML in China however, we intend to conscientiously monitor the
treatment paradigms of hematological malignancies and the industry landscape revolving
around CDK9 inhibitors and formulate appropriate future clinical development plans and/or
assess business development opportunities that may potentially maximize the value of GFH009
in the future. Accordingly, we are not currently advancing the GFH009 development for the
treatment of AML in China as of the Latest Practicable Date. As of the Latest Practicable Date,
we have not formulated a detailed clinical development plan for GFH009 in Greater China.
We had not received any relevant regulatory agency’s objections to our clinical
development plans as of the Latest Practicable Date.
Licenses, Rights and Obligations
Jiongshuo Agreement
On May 23, 2018, we entered into a technology transfer agreement with Shanghai
Jiongshuo Pharmaceutical Technology Co., Ltd (ʮ̡,“ Jiongshuo ”) in
relation to GFH009. In October 2018, we entered into a supplementary agreement with
Jiongshuo to clarify that we shall be the sole owner of all the patents and patent applications
covering GFH009, and Jiongshuo shall transfer the ownership of a specified patent application
(the “ Project Patent ”) to us. Jiongshuo is a company incorporated under the laws of the
People’s Republic of China and an Independent Third Party to us.
In 2018, when GFH009 was still in the preclinical stage of development, we bought
GFH009 because GFH009 exhibited high selectivity for the CDK family proteins, strong
activities and good solubility, making it suitable for development into an injectable solution for
the treatment of AML and other hematologic malignancies with clear clinical need and
significant market potential.
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Pursuant to the aforementioned agreements with Jiongshuo (“ Jiongshuo Agreements ”),
Jiongshuo transferred to us the designated pharmacological research reports or original records
as well as all patent application materials related to GFH009. The Jiongshuo Agreements
established a “scientific enforcement and monitoring committee” which is composed of
representatives designated by each party and should hold quarterly meetings to assess the
project progress. The committee may, on a consensus basis, vote to terminate the project.
Pursuant to the Jiongshuo Agreements, we paid Jiongshuo a one-time technology transfer fee
of RMB6 million. The Jiongshuo Agreements allowed us to seek collaboration with third-party
pharmaceutical companies to transfer rights under the Project Patent to other third parties after
obtaining regulatory approval for clinical development. If such activities occur prior to the
expiration of the term of the Project Patent, we agreed to share a portion of the fees that we
receive from such activities, with the percentage amounts specified in accordance with the
development stages when such activities occur, ranging from mid-single digit to mid-teens. In
accordance with this obligation, we made an aggregate payment of RMB9.9 million in 2022
and 2024 to Jiongshuo after entry into the SELLAS License Agreement (as defined below).
Jiongshuo is also entitled to a less than 1% royalty on the net annual sales if GFH009 is
advanced to commercialization after we transfer GFH009 to third parties, or a single-digit
percentage royalty on the net annual sales if GFH009 is advanced to market by our Company
alone.
Jiongshuo agreed to indemnify us for any liabilities imposed on us due to infringement
of a third party’s legal rights by practicing the patents or technologies transferred under the
Jiongshuo Agreements. Jiongshuo’s obligation of such indemnification has not been triggered
as of the Latest Practicable Date.
Jiongshuo and we agreed to attempt to settle all disputes arising out of the Jiongshuo
Agreements in an amicable manner. If such disputes cannot be so resolved, the parties should
resort to the China International Economic and Trade Arbitration Commission to resolve the
disputes by arbitration in Shanghai.
The term of the Jiongshuo Agreements shall continue until completion of all of the
obligations of the parties. However, either party may terminate the Jiongshuo Agreements (i)
when the other party commits a material breach and fails to remedy within 30 days of receipt
of notice from the non-breaching party, (ii) by executing another written agreement with the
other party to terminate the Jiongshuo Agreements, or (iii) by a written notice to the other party
when performance of the Jiongshuo Agreements is rendered impractical or impossible by force
majeure .
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SELLAS License Agreement
We collaborated with SELLAS to facilitate the swift development and approval of
GFH009 for commercialization outsider Greater China, while we retain development and
commercialization rights within Greater China. SELLAS is a U.S. based, NASDAQ-listed
company with superior capabilities and resources in clinical development in the fields of AML,
other hematological tumors and solid tumors. Our collaboration with SELLAS leverages the
latter’s accumulated expertise in conducting clinical trials of drug candidates targeting
hematological malignancies and solid tumors in the U.S.
On March 31, 2022 (the “ SELLAS Effective Date ”), we entered into a license agreement
(the “ SELLAS License Agreement ”) with SELLAS. Pursuant to the SELLAS License
Agreement, we granted SELLAS an exclusive (even to ourselves), sublicensable and
royalty-bearing right and license to develop, manufacture and commercialize GFH009 across
all therapeutic and diagnostic uses worldwide outside of Greater China (Mainland China, Hong
Kong, Macau and Taiwan). For details, see “— Major Collaboration and Licensing
Arrangements.”
SELLAS is a U.S. based, NASDAQ-listed company with superior capabilities and
resources in clinical development in the fields of AML, other hematological tumors and solid
tumors. By 2022, we had obtained IND approvals from both the FDA and the NMPA for the
Phase I clinical trial of GFH009. To accelerate the overseas clinical development of GFH009,
we entered into the licensing agreement with SELLAS.
On October 13, 2022, we entered into a master clinical supply agreement (the “ SELLAS
Clinical Supply Agreement ”) with SELLAS concerning the supply of the GFH009 by us to
SELLAS for clinical use and development activities outside of Greater China contemplated in
the SELLAS License Agreement. Pursuant to the SELLAS Clinical Supply Agreement, we are
responsible for manufacturing (either by us or designated CMOs) and supplying GFH009
products in applicable formulation(s) and dosage form(s) as specified by SELLAS. SELLAS
shall provide us an order every six months with the product and delivery details. SELLAS will
pay us a per unit price for our supply of GFH009 equal to 100% of the fully burdened
manufacturing cost per unit plus a percentage of mid-twenties of our full-time equivalent
(“FTE”) cost for the manufacturing management to the extent not already included in the full
burdened manufacturing cost, with a specified capped unit price within three years following
the date of execution of the SELLAS Clinical Supply Agreement. Unless earlier terminated, the
SELLAS Clinical Supply Agreement will be effective until GFH009 is no longer developed by
SELLAS outside of Greater China. Either party may terminate the SELLAS Clinical Supply
Agreement in the event of material breach of the other party as detailed in the SELLAS Clinical
Supply Agreement. SELLAS may terminate SELLAS Clinical Supply Agreement at any time
by providing us a written notice of termination, which includes an effective date of termination
at least 60 days after the date of the notice. The SELLAS Clinical Supply Agreement will
terminate automatically upon the termination of the SELLAS License Agreement.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET GFH009
SUCCESSFULLY.
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GFH018: A Small Molecule Inhibitor of TGF- /H9252R1 as a Potential Treatment of Cancer
Overview
GFH018 is a potent small-molecule inhibitor of TGF- /H9252R1. Elevated expression of TGF- /H9252
signaling genes is linked to various solid tumors. Results from a Phase I clinical trial in patients
with advanced solid tumors in Mainland China demonstrated potentially favorable safety and
preliminary efficacy profiles of GFH018.
Scope of IND Approval. In May 2019, the NMPA approved our IND application to
conduct a Phase Ib/II clinical trial of GFH018 in patients with advanced solid tumors. In June
2022, the NMPA approved our IND application to conduct a Phase Ib/II clinical trial of
GFH018 in combination with toripalimab in patients with advanced solid tumors. The IND
approval and the approved trial protocol did not specify the intended line of treatment. No
head-to-head comparison is required or planned prior to the pivotal trial.
Mechanism of Action
TGF- /H9252is a multifunctional cytokine that binds to and activates TGF- /H9252receptor II
(“TGF- /H9252R2”) on the cell membrane. In turn, TGF- /H9252R2 phosphorylates and activates
TGF- /H9252RI, which subsequently phosphorylates downstream Smad2/3, regulating gene
expression and facilitating various biological functions. In cancer cells, activation of the
TGF- /H9252signaling pathway promotes epithelial-to-mesenchymal transition and metastasis,
inhibits antitumor immune responses, and enhances angiogenesis and tissue fibrosis within the
tumor microenvironment, thereby driving tumor progression. Furthermore, elevated expression
of TGF- /H9252signaling pathway genes in blood and tumors has been observed in patients with
various solid tumor, and higher levels of TGF- /H9252expression are also positively correlated with
poorer differentiation, advanced tumor stages, and worse prognosis.
GFH018, a small-molecule inhibitor of TGF- /H9252R1, is designed to inhibit the TGF- /H9252
signaling pathway and suppress tumor growth and progression through multiple mechanisms,
including the reduction of tumor metastasis, enhancement of antitumor immune responses
within the tumor microenvironment, and inhibition of intra-tumor angiogenesis. In addition,
the expression level of the TGF /H92521 gene is negatively correlated with patient response to
PD-1/L1 antibody treatment. Inhibitors of the TGF- /H9252signaling pathway have been shown to
enhance efficacy in animal models when combined with immune checkpoint inhibitors. This
approach indicates a potential for a synergistic antitumor effect when GFH018 is combined
with PD-1/L1 immune checkpoint inhibitors.
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GFH018X1101: A Phase I clinical trial to evaluate safety, tolerability, and PK of GFH018 in
patients with advanced solid tumors in Mainland China sponsored by us
Overview. This first-in-human, non-randomized, open-label, single-arm Phase I clinical
trial aims to evaluate safety, tolerability, and PK of GFH018 in patients with advanced solid
tumors following single and multiple administrations. The primary objective is to evaluate
safety and tolerability of GFH018 and to determine its MTD and/or RP2D.
Trial design. The clinical trial consists of a dose escalation part to determine MTD and/or
recommended extended dose (“ RDE”); and a dose expansion part to confirm safety of RDE
dosing and establish RP2D and to evaluate preliminary efficacy. In the dose escalation phase,
47 patients were enrolled. Of these, 41 patients received doses ranging from 5 mg to 85 mg
BID, following a 14-day dosing and 14-day withdrawal schedule of GFH018. Six patients
received 85 mg BID with a 7-day dosing and 7-day withdrawal schedule. In the dose expansion
phase, three patients were enrolled and received 85 mg BID with a 14-day dosing and 14-day
withdrawal schedule of GFH018.
The primary endpoints are to evaluate (i) DLT, (ii) incidence and severity of AEs and
SAEs, and (iii) laboratory tests, vital signs, electrocardiogram, and cardiac ultrasound
examinations.
The key inclusion criteria for the trial include but are not limited to: (i) male or female
patients aged 18 to 75 (inclusive); (ii) patients with a life expectancy of 12 weeks or more; (iii)
patients with adequate organ and bone marrow function without severe hematopoietic
abnormalities and cardiac, pulmonary, hepatic, renal functional abnormalities or
immunodeficiencies; (iv) patients with an evaluable lesion for the first dose escalation part or
patients with at least one measurable target lesion for the second dose expansion part; and (v)
patients with histologically or cytologically confirmed diagnosis of advanced solid tumors who
have no standard therapy or who have failed after standard therapy or for whom standard
therapy is not appropriate at this stage. The key exclusion criteria for the trial include but are
not limited to: (i) patients with significant underlying disease of the cardiovascular system; (ii)
patients with significant gastrointestinal disorders; (iii) patients with clinically uncontrolled
pleural and abdominal fluid; (iv) patients with active or previous autoimmune disease with
potential for relapse; or (v) patients with major organ surgery within four weeks prior to first
dose.
Status. The trial was initiated in August 2019 and completed in August 2022 in Mainland
China. It enrolled 50 patients with various advanced solid tumors for the dose escalation and
dose expansion parts.
Safety Data. GFH018 was safe and well-tolerated across the 5 mg to 85 mg BID dosing
range, following a 14-day dosing and 14-day withdrawal schedule. No DLT was observed, and
MTD was not reached. There were no drug-related deaths or other SAEs. The incidence of
TEAEs leading to discontinuation of treatment was 4.0% (2/50), with no TRAEs leading to
discontinuation. The incidence of TEAEs and TRAEs leading to discontinuation was 14.0%
(7/50) and 6.0% (3/50), respectively. No TEAEs or TRAEs resulted in dose reductions. The
majority of TEAEs and TRAEs were Grade 1-2, with similar incidence and severity across all
dose groups.
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In the GFH018 85 mg BID dosing group following a 7-day dosing and 7-day withdrawal
schedule, there were no GFH018-related deaths, other SAEs, or events leading to termination
of treatment, treatment suspension, or reduction in TEAEs and TRAEs. Compared to the
GFH018 85 mg BID dosing group following a 14-day dosing and 14-day withdrawal schedule,
there were no significant differences in TEAEs and TRAEs. Overall, GFH018 demonstrated a
good safety and tolerability profile within the dose range. The RP2D of GFH018 was 85 mg
BID following a 14-day dosing and 14-day withdrawal schedule. Overall, GFH018
demonstrated a favorable safety profile.
GFH018X0201: A Phase Ib/II clinical trial to evaluate safety, tolerability, PK, and preliminary
efficacy of GFH018 in combination with Toripalimab in patients with advanced solid tumors
in Mainland China, Taiwan and Australia sponsored by us
Overview. This is a multicenter, non-randomized, open-label, single-arm Phase Ib/II
clinical trial to evaluate safety, tolerability, PK, and preliminary efficacy of GFH018 in
combination with Toripalimab in patients with advanced solid tumors. The primary objective
of Phase Ib trial is to evaluate the safety and tolerability of the combination therapy. The
primary objective of Phase II trial is to evaluate efficacy of the combination therapy.
Trial design. The clinical trial consists of a dose escalation Phase Ib part in patient with
advanced solid tumors and an indications expansion Phase II part in patients with advanced
solid tumors of 14 specific tumor types. The tumor types of Phase II trial include hepatocellular
carcinoma, cholangiocarcinoma/cholangiocarcinoma (except pot-bellied carcinoma),
pancreatic cancer, colorectal cancer, uroepithelial carcinoma, cervical cancer, squamous cell
carcinoma of head and neck, squamous cell carcinoma of esophagus, nasopharyngeal
carcinoma, thymic carcinoma, endometrial carcinoma, osteosarcoma, triple-negative breast
carcinoma, and extranodal NK/T-cell lymphoma. The primary endpoints of Phase Ib trial are
to evaluate (i) incidence of DLT events; (ii) incidence and severity of AEs, SAEs, adverse
events of special interest (“ AESIs ”), immune-related adverse events (“ irAEs ”); and (iii)
changes in laboratory tests, vital signs, physical examination, electrocardiogram. The
secondary endpoints of Phase Ib trial are to assess (i) plasma drug concentration and pk
parameters for single dose administration of GFH018; (ii) C
trough of Toripalimab and number
and percentage of patients producing anti-Toripalimab antibodies; and (iii) ORR, DCR, TTR,
DoR, PFS, and OS. The primary endpoints of Phase II trial are to evaluate ORR, DCR, TTR,
DoR, PFS, and OS. The secondary endpoints of the Phase II trial are to assess incidence and
severity of AEs, SAEs, AESIs, irAEs; (ii) C
trough of GFH018; and (iii) C trough of Toripalimab
and number and percentage of patients producing anti-Toripalimab antibodies.
For the Phase Ib part, 15 patients received doses of 40 mg, and 80 mg BID, following a
14-day dosing and 14-day withdrawal schedule of GFH018 combined with toripalimab 3 mg/kg
by intravenous infusion every 2 weeks. For the Phase II part, 133 patients were divided into
14 groups according to specific tumor types and received GFH018 80 mg BID for 14 days on
and 14 days off combined with toripalimab 3 mg/kg by intravenous infusion every 2 weeks.
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The key inclusion criteria for the trial include but are not limited to: (i) patients aged 18
or older; (ii) patients with a life expectancy of 12 weeks or more; (iii) patients with adequate
organ function; (iv) patients whose toxic response to prior antitumor therapy has returned to
baseline levels or CTCAE Grade 1 level; and (v) patients with an advanced or metastatic tumor
confirmed by histology or cytology that has failed at least one line of standard therapy, is not
amenable to standard therapy due to intolerable toxicity, or for which no standard therapy is
available. The key inclusion criteria for the Phase II part further include but are not limited to:
(i) patients with a specific type of advanced or metastatic tumor diagnosed by histology or
cytology; and (ii) patients with at least one measurable lesion. The key exclusion criteria for
the trial include but are not limited to: (i) patients with impaired cardiac function or clinically
significant heart disease; (ii) patients with an acute or chronic infection; (iii) patients with
active central nervous system metastases; (iv) patients with active autoimmune disease or a
history of autoimmune disease within one year prior to enrollment; or (v) patients with
significant gastrointestinal disorders.
Status. The trial was initiated in June 2022 in Mainland China, November 2021 in Taiwan
and October 2021 in Australia, respectively, and was completed in December 2023.
Safety Data. For patients who received 40 mg BID and 80 mg BID following a 14-day on
and 14-day off schedule in combination with Toripalimab in the Phase Ib trial, no patients
developed DLTs, and the MTD was not reached. The RP2D of GFH018 in combination with
Toripalimab is 80 mg BID following the same 14-day on and 14-day off schedule. In this study,
73.6% of patients had at least one TRAE related to the combination regimen, with 19.6% of
these patients experienced at least one Grade 3 or higher TRAE. The incidence of treatment
related SAEs was 11.5%. The most common TRAEs included rash 26.4% (39/148), fatigue
14.2% (21/148), anemia 11.5% (17/148), nausea 11.5% (17/148), pruritus 11.5% (17/148), and
increased aspartate aminotransferase 10.8% (16/148). No other safety signals were observed,
and the combination of GFH018 and toripalimab did not increase toxicity. Overall safety and
tolerability were good.
Efficacy Data. The confirmed best overall response was 16.2% (90% CI: 11.44% to
22.04%) and the DCR was 35.8% (90% CI: 29.25% to 42.80%). Specifically, in
nasopharyngeal carcinoma patients without any prior treatment with immune checkpoint
inhibitors (n = 25), the confirmed ORR was 40% (90% CI: 23.6-58.3%) and DCR was 60%
(90% CI: 41.7-76.4%). The median PFS was 9.0 months (90% CI: 1.9-NR), and median DoR
was not reached. The results demonstrated that GFH018, in combination with Toripalimab,
showed synergistic anticancer activity in solid tumors such as nasopharyngeal carcinoma.
Clinical Development Plan
In addition to the two clinical trials described above, in the past we conducted a Phase II
clinical trial to evaluate the efficacy and safety of GFH018 in combination with Toripalimab
with concurrent chemoradiotherapy in patients with unresectable, locally advanced stage III
NSCLC in China. We decided to focus on other more promising pipeline programs after we
initiated the clinical trial to best leverage our limited resources. We will continue to assess our
development strategy on GFH018 and formulate appropriate clinical development plan in the
future.
We had not received any relevant regulatory agency’s objections to our clinical
development plans as of the Latest Practicable Date.
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Licenses, Rights and Obligations
WuXi Agreements
In June 2017, GenFleet HK, a member of the Single Largest Group of Shareholders,
entered into a joint development agreement with WuXi AppTec (Shanghai) Co., Ltd. ( ɪऎᖹ
ʮ̡)( “WuXi AppTec SH ”) in relation to the development of an inhibitor
against TGF- /H9252receptor (hereafter referred to as GFH018) (as amended and supplemented, the
“GFH018 Joint Development Agreement ”). Between September 2017 and December 2018,
members of our Group entered into several supplemental agreements to the GFH018 Joint
Development Agreement with WuXi AppTec SH, pursuant to which we were assigned with all
rights, privileges and obligations related to GFH018 under the GFH018 Joint Development
Agreement. In March 2020, we entered into a confirmatory patent assignment agreement with
an affiliate of WuXi AppTec SH, which was then the applicant of certain patent applications
regarding GFH018. Pursuant to the confirmatory patent assignment agreement, we were
assigned with all patent rights associated with GFH018 listed thereunder.
Pursuant to the aforementioned agreements (“ WuXi Agreements ”), WuXi AppTec SH
was responsible for conducting preclinical studies of GFH018, and our Company is responsible
for applying for and obtaining IND approval, as well as conducting subsequent clinical
development. The WuXi Agreements set out each parties’ cost contribution to the pre-IND
research and development activities. For the clinical development, we shall be solely
responsible for the associated costs, and we incurred RMB115.3 million for the clinical
development of GFH018 since 2019. We agreed to share a portion of the fees (in the
low-to-mid double-digit percentage range) that we receive when we transfer the molecule to
other third parties, with the percentage amounts specified in accordance with the development
stages when such transfer occurs. WuXi AppTech SH is entitled to a single-digit percentage
royalty on net annual sales once GFH018 is commercialized. The WuXi Agreements
established a “project committee” composed of six individuals, with three representatives from
each party. The “project committee” has decision-making authority with respect to the planning
and implementation of the R&D projects provided under the WuXi Agreements.
WuXi AppTec and we agreed to attempt to settle all disputes arising out of the WuXi
Agreements in an amicable manner. If such disputes cannot be so resolved, either party may
refer the disputes to the China International Economic and Trade Arbitration Commission,
which shall finally resolve the disputes by an arbitration award legally binding to both parties.
The WuXi Agreements may be terminated by mutual agreement of both parties but cannot
be terminated before March 30, 2018. The R&D activities for GFH018 under the Wuxi
Agreements were completed in 2018, and we have fulfilled our payment obligations for such
R&D activities under the Wuxi Agreements. As such, WuXi AppTech SH is no longer involved
in the decision making of the R&D activities and progression of GFH018 under the Wuxi
Agreements.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET GFH018
SUCCESSFULLY.
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Below is a summary of the clinical results and development status of our drug candidates
in clinical development stage.
Compound(s)
Country/
region of
clinical
development
Development
status
Clinical trial
participants
Key safety results
(with Grade 3 or
above AEs, if any) Key efficacy results
Impact of
adverse events (3)
GFH925 +
cetuximab (1)/H1118
EU Phase II trial
ongoing for
NSCLC
Patients with previously
untreated advanced
NSCLC harboring
KRAS G12C
mutation, including 6
patients in Phase I
and 40 patients in
Phase II
Overall, the combination
therapy presented a
favorable safety/
tolerability profile.
TRAEs occurred in
87.2% of patients and
the majority of the
TRAEs were graded
1-2; 14.9% of patients
experienced at least
one grade 3 TRAEs;
no grade 4-5 TRAEs.
Interim Phase II results
showed that, among
the 45 patients who
received at least one
post-treatment tumor
assessment, the ORR
was 80% and DCR
was 100%.
Suspension/discontinuation
of individual participants
due to TRAEs include:
one patient required
dose reductions; four
patients, required
suspension of GFH925
treatment; three patients
discontinued cetuximab
treatment.
GFH925 /H1118/H1118/H1118Mainland
China
Regulatory
approval for
NSCLC
No less than
293 patients with
advanced NSCLC
with KRAS G12C
mutations, including
116 patients in Phase
II trial
In Phase II, 14.0% of
patients had SAE.
In Phase II, ORR was
49.1%, and DCR was
90.5%.
Suspension/discontinuation
of individual participants
due to AEs include:
2.7% of patients
required drug
discontinuation; 32.6%
required drug
suspension; 18.3%
required dose reduction.
GFH375
(2) /H1118/H1118Mainland
China
Phase I/II trial
ongoing for
solid tumors
62 patients with
advanced solid tumors
harboring the KRAS
G12D mutation,
including 33 patients
with PDAC, 16
patients with NSCLC,
8 patients with CRC
and 5 patients with
other solid tumors in
Phase I/II trial
In Phase I, 29.0% of
patients had Grade 3
TRAEs and 8.1% of
patients had treatment
related SAEs.
among 49 patients at
daily dosages of 400
or 600 mg: 43
patients who received
tumor assessment
achieved an ORR of
42% and a DCR of
91%; the ORR was
52% and DCR was
100% among 23
efficacy-evaluable
PDAC patients, and
the ORR was 42%
and DCR was 83%
among 12 efficacy-
evaluable NSCLC
patients
52 patients across all
dose levels and
indications who
received tumor
assessment: the
overall ORR was 38%
and DCR was 90%.
Suspension/discontinuation
of individual participants
due to TRAEs include:
11% of patient required
does reduction; 21% of
patient required dose
interruption, 3% of
patient required
treatment
discontinuation.
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Compound(s)
Country/
region of
clinical
development
Development
status
Clinical trial
participants
Key safety results
(with Grade 3 or
above AEs, if any) Key efficacy results
Impact of
adverse events (3)
GFH312 /H1118/H1118/H1118Mainland
China and
Australia
Phase I trial
ongoing for
PAD with IC
and PBC
26 healthy individuals
in China and 76
healthy individuals in
Australia in Phase I
trial
The results demonstrate
a favorable safety
profile, with no Grade
3 or above AEs, SAEs
or deaths.
N/A None
GFH009 /H1118/H1118/H1118Mainland
China and
U.S.
Phase I trial
for AML in
China
completed;
Phase II
trial in
combination
with other
drugs for the
treatment of
AML
conducted by
SELLAS in
the U.S. is
ongoing
34 AML patients, and
52 lymphoma patients
in Phase I trial
In Phase I, 26 AML
patients had Grade 3
or higher TEAEs. 14
AML patients had
Grade 3 or higher
TRAEs. 12 AML
patients had SAEs,
with 5 being drug
related.
In Phase I, 27
lymphoma patients
had Grade 3 or higher
TEAEs. 20 lymphoma
patients had Grade 3
or higher TRAEs.
15 lymphoma patients
had SAEs, with 10
being drug related.
In Phase I, one AML
patient achieved
complete remission,
with a complete
remission rate of
2.9%.
In Phase I, five
lymphoma patients
achieved partial
response and nine
achieved stable
disease.
Suspension/discontinuation
of individual participants
due to AEs include: for
AML patients, 9.1%
required drug
discontinuation; 29.4%
required drug
suspension. For
lymphoma patients,
9.6% required drug
discontinuation; 21.2%
required drug
suspension; 8% required
dose reduction.
GFH018 /H1118/H1118/H1118Mainland
China,
Taiwan and
Australia
Phase II trial
completed
patients with various
advanced solid tumors
Overall safety and
tolerability were
good.
19.6% patients had
Grade 3 or higher
TRAEs, and 11.5%
had SAEs.
ORR was 16.2%, and
DCR was 35.8%.
None
Notes:
(1) The clinical trial statistics are as of January 14, 2025.
(2) The clinical trial statistics of key safety results are as of March 31, 2025, and those of key efficacy are as of
May 16, 2025.
(3) The competent authorities did not raise any safety concerns or impose any conditions due to the adverse events
that occurred in the clinical trials indicated in the table. Most of these adverse events occurred in the Phase
I clinical trials, whose primary objective is to select the appropriate drug dosage and target patient group based
in part on the occurrence of adverse events. As such, the frequency of adverse events that occurs with certain
drug dosage or target patient group may be higher than others. The adverse events caused temporary
suspension or discontinuation of clinical trial for certain individual patients, but not an entire clinical trial.
MAJOR COLLABORATION AND LICENSING ARRANGEMENTS
We have successfully entered into multiple collaboration and licensing agreements with
domestic and international partners to expand our coverage in the global market, and maximize
the commercial value of our product portfolio. We select our partners with rigorous criteria and
strategic synergy for the benefits of the research and development of drug products, and we had
not had material disputes with our partners since entering of such agreements.
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Innovent Agreement
On September 1, 2021, we entered into a license and option agreement (the “ GFH925
License Agreement ”) with Innovent. On January 11, 2024, we further entered into a
supplementary agreement (the “ GFH925 Supplementary Agreement ,” together with the
GFH925 License Agreement, the “ Innovent Agreement ”) with Innovent.
License Agreement with Innovent
On September 1, 2021, we entered into a license and option agreement (the “ GFH925
License Agreement ”) with Innovent, a biopharmaceutical company incorporated in the
Cayman Islands and listed on the Hong Kong Stock Exchange (stock code: 1801). Innovent
specializes in developing and commercializing monoclonal antibodies and other drug assets in
the fields of oncology, ophthalmology, autoimmune diseases, and cardiovascular and metabolic
diseases. In September 2021, Innovent assigned all of its rights, privileges and obligations for
the territory of Greater China under the GFH925 License Agreement to Innovent Biologics
(Suzhou) Co., Ltd. (“ Innovent Suzhou ”), a company incorporated under the laws of the
People’s Republic of China and a wholly owned subsidiary of Innovent. Each of Innovent and
Innovent Suzhou is an Independent Third Party to us.
Obligations and Responsibilities
According to the GFH925 License Agreement, we grant to Innovent (i) an exclusive,
royalty-bearing and sublicensable license under all GenFleet Intellectual Property
2 to research,
import, develop, make (have made), manufacture (have manufactured), 3 use, commercialize,
sell, offer to sell, distribute, market and promote pharmaceutical products (the “ Licensed
Product ”) consisting of or containing compounds targeting KRAS G12C mutation (the
2 The “GenFleet Intellectual Property” means any and all the know-how, trademarks, patents and patent
applications that we have obtained an interest in, in a way independent from licensing under the GFH925
License Agreement, such that we may license that interest to Innovent or its affiliates, and (1) such know-how
is necessary or reasonably useful in connection with the development, commercialization or other use of the
Licensed Product as a treatment for human diseases within Greater China, (2) such trademarks are used in
connection with, intended for use, or adopted for use in connection with the Licensed Product, and (3) such
patents and patent applications are registered within Greater China and cover the composition of, or methods
to manufacture or use the Licensed Product.
3 The word “import” means the act of bringing objects into a country/region from other countries/regions. The
GFH925 License Agreement, by using this word, allows Innovent to bring Licensed Products into Greater
China from other regions of the world. The phrase “make (have made)” means the act of creating or forming
something, regardless of whether the act is completed before or after the execution of the GFH925 License
Agreement. The GFH925 License Agreement, by using this phrase, allows Innovent to create or form Licensed
Products within Greater China, whether before or after the execution of the GFH925 License Agreement. The
word “manufacture (have manufactured),” means all operations involved in the manufacturing, quality control
testing (including in-process, release and stability testing, if applicable), storage, releasing and packaging of
the Licensed Product, regardless of whether the operations are completed before or after the execution of the
GFH925 License Agreement. The GFH925 License Agreement, by using this phrase, allows Innovent to
conduct any operations involved in the manufacturing, quality control testing (including in-process, release
and stability testing, if applicable), storage, releasing and packaging of the Licensed Product within Greater
China, whether the operations are completed before or after the execution of the License Agreement.
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“Licensed Compounds ”) as specified in the GFH925 License Agreement, including GFH925,
for the treatment, prevention or diagnosis of any disease or condition in humans in Mainland
China, Hong Kong, Macau and Taiwan (the “ Greater China ”); and (ii) an exclusive option (the
“Ex-China Option ”) to develop and commercialize Licensed Product in the all countries and
regions in the world other than Greater China (the “ Ex-China Territory ”). The Ex-China
Option was never exercised by Innovent and was terminated on January 11, 2024. For
additional information, see “— Supplementary Agreement with Innovent.” There was no
transfer of rights of GFH925 in the Ex-China Territory before the termination of the Ex-China
Option from us to Innovent, and we conducted overseas clinical development of GFH925
during the same period.
The GFH925 License Agreement established a JSC, which is a forum for the
communication and decision-making regarding the parties’ activities under the agreement. We
and Innovent shall each appoint three representatives to the JSC and select one representative
as each side’s co-chairperson for the JSC. The JSC may change its size from time to time by
mutual consent of the parties, provided that the JSC will consist at all times of an equal number
of representatives of each party. When voting on any matter properly before the JSC, each party
shall have one vote cast by its respective co-chairperson. The JSC holds meetings at least once
a quarter and at other times as the co-chairpersons may reasonably determine. All decisions
within the JSC must be made on a consensus basis. If the JSC encounters a deadlock on a
matter and cannot make a decision, the matter may be referred to the parties’ Senior
Representatives (i.e., our Chief Medical Offer and Innovent’s President and Head of R&D) to
negotiate and decide. If the parties’ Senior Representatives still cannot resolve the matter, then
Innovent shall have the final decision-making authority for matters within Greater China, and
we shall have the final decision-making authority for matters outside Greater China.
We conducted all preclinical development of GFH925 and submitted an IND application
for the first-in-human GFH925X1101 trial to the NMPA in May 2021. We were responsible for
the trial design that resulted in the NMPA ’s approval in July 2021 and the approval was
addressed to us without any material inquiries or objections. In preparation for the clinical trial
and prior to entering into the GFH925 License Agreement, we proactively identified and
finalized the arrangement details with the lead principal investigator. We also arranged eight
clinical sites in multiple provinces in China, submitted materials for ethics committee
approvals for a number of these clinical sites, and activated one clinical trial site in August
2021. Innovent later supported the clinical collaboration by expanding the trial from the eight
sites we initially arranged to a total of 55 clinical sites.
After signing of the GFH925 License Agreement, Innovent became the sponsor of the
GFH925X1101 trial in China and is thereafter solely responsible for the development and
commercialization of GFH925 in the Greater China region. However, we retain a critical role
in managing the CMC-related processes, including overseeing process development, finalizing
agreements with key stakeholders, and selecting suitable vendors to ensure smooth trial
execution. We retain this critical role for several reasons. First, we still retain the ex-China
rights of GFH925, which is currently under clinical development overseas, such as in the U.S.
and Europe. As the sponsor of such overseas clinical trials, we are responsible for supplying
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GFH925 for these trials. Thus, we need to manage the CMC-related process of GFH925 in the
overseas markets. Second, though the Greater China rights of GFH925 have been granted to
Innovent, it serves our interest to maintain consistency of GFH925 in formulation and quality
in its different target markets. Especially, any quality related issues of GFH925, a Core Product
of us, may affect our commercial reputation. Third, equipped with in-depth expertise in CMC
(see “— Chemistry, Manufacturing and Controls (“CMC”)”), we are well positioned to take
responsibility in managing the CMC-related process. Fourth, managing the CMC-related
process of GFH925 and other drug candidates fits with our plan to establish an in-house
manufacturing facility to support the formulation production of our pipeline products. The
GFH925 License Agreement does not require Innovent to procure GFH925 exclusively from
us. However, we have the priority to be appointed by Innovent as the manufacturer and supplier
of GFH925 provided that the terms and conditions of our manufacturing and supply are the
same or more favorable as provided by other third party to Innovent. Innovent will pay our
Company for the drug supply on an ongoing basis, with payments determined by the quantity
required to support the trial’s development needs. After the regulatory approval of GFH925 in
China in August 2024, we became the supplier of GFH925 to Innovent. In 2024, we generated
RMB14.7 million of sales revenue from the supply of GFH925 to Innovent.
Furthermore, Innovent grants to us an exclusive and sublicensable license under all
Innovent Intellectual Property
4, solely for the purpose of developing and commercializing the
Licensed Product in the Ex-China Territory.
Intellectual Property
According to the GFH925 License Agreement, we shall remain the exclusive owner of
GenFleet Intellectual Property. Innovent shall remain the exclusive owner of Innovent
Intellectual Property.
In addition, both parties shall jointly own the intellectual property rights generated from
any joint efforts of both parties, including any inventions generated, developed, conceived or
reduced to practice (constructively or actually) jointly by or on behalf of Innovent and us, their
affiliates and respective sublicensees, in the course of the development, manufacture or
commercialization of the Licensed Compounds or the Licensed Product according to the
GFH925 License Agreement. Each party may freely exploit such joint inventions without any
duty to account to or obtain consent from the other party, provided that each party shall
disclose in writing to the other party all joint inventions promptly following the generation,
development, conception or reduction to practice thereof. However, Innovent was granted the
first right (but not the obligation) to file and maintain the patents that cover inventions jointed
developed by both parties. After the termination of the Ex-China Option under the GFH925
4 The “Innovent Intellectual Property” means any and all the know-how, patents and patent applications that
Innovent has an obtained interest in, in a way independent from licensing under the GFH925 License
Agreement, such that Innovent may license that interest to us, and (1) such know-how is necessary or
reasonably useful in connection with the development, commercialization or other use of the Licensed Product
as a treatment for human diseases within Greater China and (2) such patents and patent applications cover the
composition of, or methods to manufacture or use, the Licensed Product or the Licensed Compounds.
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License Agreement in January 2024, we and Innovent separately conducted R&D activities
with respect to GFH925 in each one’s respective regions (i.e., Innovent in Greater China and
we in Ex-China Terrority). As of the Last Practicable Date, the parties conducted, and expected
to continue to conduct, R&D activities with respect to GFH925 at different geographical
locations in accordance with the GFH925 License Agreement and, as such, no such joint
inventions could have occurred. As of the same date, neither party has obtained any patent or
filed any patent application for the joint inventions under the Innovent Agreement. As of the
same date, to our best knowledge, we are not aware of patents, patent applications or
know-how of Innovent that relate to GFH925.
In addition, we have an obligation to indemnify Innovent the potential penalties arising
from patent infringement of IP claims asserted by a third party in Greater China.
Payments
Under the GFH925 License Agreement, Innovent has agreed to make various payments to
us, including but not limited to, an upfront fee, development and regulatory milestone
payments, commercial milestone payments, royalty payments. Innovent will pay us a one-time,
non-refundable and non-creditable upfront fee of US$22.0 million, comprising US$8.5 million
for the license and US$13.5 million for the Ex-China Option for Ex-China Territory.
Upon achieving (i) pre-specified development and regulatory milestones triggered by
certain clinical development progress and regulatory filing regarding GFH925 in Greater
China, we are eligible to receive up to US$27 million milestone payments from Innovent, (ii)
pre-determined commercialization milestones triggered by reaching annual sales of GFH925 in
Greater China of at least hundreds of millions of U.S. dollars per year, we are eligible to
receive up to US$105 million milestone payments from Innovent. Innovent is also obligated to
pay tiered royalties ranging from a single-digit percentage to a low teen percentage of annual
net sales of GFH925 upon the achievement of specific thresholds for GFH925 annual net sales
achieved by Innovent, its affiliates and sublicensees (although we are not aware of any such
sublicensees as of the Latest Practicable Date) on a region-by-region basis. Net sales refers to
the gross amount invoiced, less applicable discounts, shipping charges, and taxes as well as
customary adjustments. Net sales shall be determined in accordance with US GAAP , IRFS or
other accounting standard.
As of the Latest Practicable Date, we had received US$49.6 million under the GFH925
License Agreement, consisting of US$22.0 million upfront payments, US$27.0 million
development and regulatory milestones and US$0.6 million royalties, and the milestones in
commercialization of GFH925 in Greater China have not been triggered.
Dispute Resolution
The GFH925 License Agreement shall be governed by the laws of the PRC, without
regard to its conflicts of law provisions and shall be finally resolved by arbitration
administered by the Shanghai International Arbitration Centre.
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Termination Clauses
Unless terminated earlier, the GFH925 License Agreement shall continue in full force and
effect until the expiration of the Royalty Term under the GFH925 License Agreement, which
is determined on a region-by-region basis, defined as: since the first commercial sale of a
Licensed Product in a region, until the last to occur of: (a) expiration of the last-to-expire valid
claim of our patent(s) covering such Licensed Product in that region; (b) ten years from the first
commercial sale of such Licensed Product in that region; and (c) the expiration of marketing
or manufacturing exclusivity on such Licensed Product conferred by the applicable regulatory
authority in that region. Innovent and we may terminate the GFH925 License Agreement by
mutual written agreement. Each party may also terminate the GFH925 License Agreement with
advance written notice upon occurrence of one of the following events: (1) the other party’s
material breach of the GFH925 License Agreement, (2) bankruptcy of the other party, (3)
withdrawal of a Licensed Product required by the competent regulatory authority in a
jurisdiction, and (4) an event of force majeure. Also, Innovent may terminate the GFH925
License Agreement in its entirety or with respect to a Licensed Product with advance written
notice (1) during the period from the initiation of the first pivotal clinical trial for the Licensed
Product and the issuance of the marketing authorization by the competent regulatory authority,
or (2) after the issuance of the marketing authorization by the competent Regulatory Authority
for the Licensed Product.
Supplementary Agreement with Innovent
On January 11, 2024, we further entered into a supplementary agreement (the “ GFH925
Supplementary Agreement ”) with Innovent. The decision to enter into the GFH925
Supplementary Agreement was based on a range of commercial considerations and aligned
with our broader strategy for international expansion. We believe the GFH925 Supplementary
Agreement was negotiated at arm’s length basis. As part of our ordinary course of business, we
routinely make strategic business development decisions, including the termination of the
Ex-China Option, which was one of many such determinations. In making this decision, we
considered (i) our own assessment of GFH925’s therapeutic potential and the addressable
markets for its intended indications, which also played a role in the decision-making process
and (ii) the growing market interest in GFH925 and the favorable reception it has received from
potential investors and partners, which highlighted its commercial appeal and supported our
efforts to secure additional financing.
Obligations and Responsibilities
According to the GFH925 Supplementary Agreement, all parties agree to terminate the
Ex-China Option under the GFH925 License Agreement, including but not limited to Ex-China
Option, development milestone payments in the Ex-China Territory and Ex-China Option
related payments. We will retain the exclusive rights to develop and commercialize the
Licensed Product and the Licensed Compounds for any indication in the Ex-China Territory.
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We may license the commercialization rights in Ex-China and/or sublicense the license
granted by Innovent under the GFH925 License Agreement through multiple tiers to any third
party, without the written consent of Innovent; provided that such sublicense will not relieve
us of any obligations under the GFH925 License Agreement and GFH925 Supplementary
Agreement, and each sublicense agreement shall not conflict with the GFH925 License
Agreement and GFH925 Supplementary Agreement.
All parties agree that upon the effective date of the GFH925 Supplementary Agreement,
we shall have sole discretion regarding the development or commercialization activities of the
Licensed Product and the Licensed Compounds in the Ex-China Territory.
The GFH925 Supplementary Agreement provides for allocation of responsibilities
between the parties for the costs incurred in our activities relating to the License Product in the
Ex-China Territory. If Innovent, at our reasonable request, provides support to our activities in
development or obtaining regulatory approval of the License Product in the Ex-China Territory,
we should reimburse Innovent for the internal and out-in-pocket costs reasonably incurred by
Innovent in providing such support. As of the Latest Practicable Date, such reimbursement has
not occurred or been triggered.
Payments
In consideration of the termination, we shall pay non-refundable termination fees to
Innovent in an aggregate of US$20.0 million (the “ Termination Fees ”) in installments by
December 1, 2026. The higher amount of the Termination Fees than the original fee paid by
Innovent on the Ex-China Option in 2021 had taken into account the appreciation of monetary
value of the Ex-China Option during such period, as well as the increasing certainty towards
the clinical development of GFH925 through the passage of time. Innovent’s efforts and
progress achieved in the clinical development of GFH925 had contributed to the added value
of the Ex-China Option. According to Frost & Sullivan, a higher amount of termination fee
than the original option fee is in line with industry norm. Especially, with the advancement of
clinical-stage development of a drug candidate and the accumulation of positive clinical trial
results, the probability of success (“ POS”) of the drug candidate’s commercialization would
increase. As the evaluation of a drug candidate usually relies on the POS, an increase of POS
will lead to an increase of drug evaluation. As of the Latest Practicable Date, we had paid
US$6.0 million to Innovent under the GFH925 Supplementary Agreement. The remaining
termination fees payment of US$14.0 million will be paid in two installments by December
2026. If we receive any payments from the sublicense transaction to a third party to use the
licensed technology/rights to develop and commercialize the product in the sublicensed
territory, we shall pay a low double-digit percentage of such sublicensing income (including
any upfront, milestone and royalty payment(s), license maintenance fees and other similar
payments) to Innovent Suzhou. We shall also pay to Innovent Suzhou revenue sharing
payments ranging from a single-digit percentage to a low double-digit percentage based on the
total annual net sales of the Licensed Product sold in the Ex-China Territory. Upon the
termination of Ex-China Option, we have the right to assign and/or transfer any of the GenFleet
Intellectual Property in the Ex-China Territory to any third party (the “ Assignee ”). If we make
and actually receive any payments from such assignment and/or transfer (the “ Assignment
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Income ”), we shall share with Innovent Suzhou the Assignment Income ranging from a low
double-digit percentage to a middle double-digit percentage depending on the stage of the
development of the Licensed Product in the Ex-China Territory and whether such Assignee is
recommended by us. The sharing of licensing payment and Assignment Income with Innovent
represented our further recognition of the progress Innovent achieved in the clinical
development of GFH925 in China and a further consideration for Innovent’s agreement to
terminate the Ex-China Option. Upon such assignment and/or transfer, if the Licensed Product
in the Ex-China Territory is at a later stage of clinical development, the Assignment Income to
be shared with Innovent Suzhou will be lower. Also, if such assignment and/or transfer is
recommended by us to Innovent Suzhou, the Assignment Income to be shared with Innovent
will be higher. In the Ex-China Territory, we have complete discretion with respect to GFH925.
In particular, we do not require Innovent’s consent, nor does Innovent have any control
(directly or indirectly) for authorizing any sublicense transaction, assignment of rights and/or
transfer of any GenFleet Intellectual Property and/or determining any of the fees involved in
such transactions. We also have complete discretion to decide whether to accept the
sublicensees/assignees/transferees recommended by Innovent.
Dispute Resolution
The GFH925 Supplementary Agreement shall be governed by the laws of the PRC,
without regard to its conflicts of laws. The dispute resolution mechanism of the GFH925
License Agreement shall also apply to the GFH925 Supplementary Agreement.
Clinical Supply Agreement with Innovent
In December 2022, we entered into a Clinical Supply Agreement with Innovent regarding
the supply of GFH925 to Innovent for use in clinical trials, the consideration of which was
determined at arm’s length basis.
Price term: Innovent shall pay us for the supply of GFH925 at a fixed price per pill in
installments according to the progress of the delivery of GFH925 as determined in the Clinical
Supply Agreement.
Quantity term: We shall supply GFH925 to Innovent in the fixed quantity according to the
time scheduled provided in the Clinical Supply Agreement.
Return policy: If the products we supply to Innovent are defective, we have an obligation
to replace the defective products for Innovent.
Duration: The Clinical Supply Agreement shall remain effective until the termination of
the GFH925 License Agreement, except that we have a right to terminate the agreement due
to Innovent’s failure to make undisputed payment within a specified period of time.
Since GFH925 has advanced into commercialization stage in China, the Clinical Supply
Agreement have since ceased to be operative without termination by either party.
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Drug Supply Settlement Agreement with Innovent
In May 2025, we entered into a Drug Supply Settlement Agreement with Innovent
regarding the commercial supply of GFH925 to Innovent, the consideration of which was
determined at arm’s length basis.
Price term: Innovent shall pay us for the supply of GFH925 at a non-adjustable fixed
price per kilogram in installments according to the progress of the manufacturing and delivery
of GFH925 as determined in the Drug Supply Settlement Agreement.
Quantity term: The Drug Supply Settlement Agreement does not set forth a minimum
purchase amount or any purchase or supply obligation on either party.
Return policy: The Drug Supply Settlement Agreement does not set forth a return policy.
However, Innovent’s payment obligations are triggered by our delivery of non-defective
products.
Duration: The Drug Supply Settlement Agreement shall remain effective until the
termination of the GFH925 License Agreement.
Settlement of previously delivered API: The Drug Supply Settlement Agreement also
specifies the settlement terms for unpaid APIs delivered prior to the execution of the agreement
but after the commencement of the commercialization stage, all of which had been fully settled
as of the Latest Practicable Date.
Innovent’ s Development of GFH925
After execution of the License Agreement, Innovent renamed GFH925 as IBI351 and has
taken over the clinical development and commercialization of IBI351 in Greater China. We are
not aware of any negative clinical results from drug programs of Innovent that may negatively
affect the development and commercialisation prospects of GFH925. Based on publicly
available information, the major progresses achieved in Innovent’s development of IBI351 are
summarized below.
Y ear Major events
2021 /H1118/H1118/H1118/H1118/H1118In September, Innovent entered into an exclusive license agreement with the
Company for the development and commercialization of GFH925 ( i.e. , the
License Agreement) in Greater China.
In September, Innovent completed the first patient dosed for Phase I/II clinical
trial of IBI351 in Chinese patients with solid tumors.
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Y ear Major events
2022 /H1118/H1118/H1118/H1118/H1118In June, the Phase I dose-escalation study results of IBI351 as monotherapy
were released at the ASCO Annual Meeting 2022. Favorable safety and
tolerability and promising antitumor activity of IBI351 monotherapy were
observed in previously treated advanced NSCLC and CRC harboring KRAS
G12C mutation.
In the second half of 2022, Innovent initiated Phase Ib studies for IBI351
combination therapy for KRAS G12C mutated cancers.
In the second half of 2022, Innovent initiated the pivotal Phase II study for
IBI351 for the treatment of 2L KRAS G12C mutated NSCLC.
2023 /H1118/H1118/H1118/H1118/H1118In January, IBI351 received NMPA BTD for the treatment of patients with
advanced NSCLC harboring KRAS G12C mutation.
In April, the updated results of the Phase I study of IBI351 as monotherapy in
patients with previously treated advanced NSCLC harboring KRAS G12C
mutation were presented at the AACR 2023.
In May, IBI351 received NMPA BTD for the treatment of patients with advanced
CRC harboring KRAS G12C mutation.
In June, the preliminary results from a pooled analysis of two Phase I studies of
IBI351 as monotherapy in patients with metastatic CRC harboring KRAS G12C
mutation were presented at the ASCO Annual Meeting 2023.
In June, Innovent entered into a clinical trial collaboration and supply agreement
with Merck KGaA for the combination therapy of IBI351 with cetuximab
(ERBITUX®) for KRAS G12C-mutated NSCLC in a Phase Ib study in China.
In November, the NMPA accepted the NDA and granted Priority Review
Designation for IBI351 monotherapy in patients with previously treated
advanced NSCLC harboring KRAS G12C mutation who have received at least
one systemic therapy.
In December, updated results from the Phase II pivotal study for IBI351 for
previously treated KRAS G12C-mutated NSCLC and CRC were presented at
ESMO Asia 2023.
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Y ear Major events
2024 /H1118/H1118/H1118/H1118/H1118Innovent initiated a Phase Ib/III clinical trial to investigate IBI351/cetuximab
combination therapy in patients with previously untreated advanced NSCLC
harboring KRAS G12C mutation.
In August, the data from the Phase II pivotal study for IBI351 for previously
treated KRAS G12C-mutated NSCLC has been published in full manuscript in
the Journal of Thoracic Oncology .
In August, the NMPA approved Dupert® (IBI351, fulzerasib) as monotherapy
for the treatment of advanced NSCLC patients harboring KRAS G12C mutation
who have received at least one systemic therapy. Dupert became Innovent’s
eleventh product in its commercial portfolio. Innovent has initiated
commercialization of Dupert® in Mainland China.
In our communications with EMA and FDA regarding applying for clinical trials of the
GFH925/cetuximab combination therapy, we submitted to the two regulatory authorities
certain clinical data generated from the GFH925X1101 study conducted by Innovent in China
(including the dosage, safety and efficacy profile of GFH925, and patient selection in the
study), as well as publicly available past clinical trial results regarding cetuximab (the safety
and efficacy profile). Apart from incorporating the above-mentioned information of GFH925
and cetuximab in our ex-China IND applications — as required under the EMA and FDA
regulatory framework for combination studies — we have not relied on any research and
development activities conducted by Innovent and other third parties. In addition, in advancing
the R&D of GFH925 in ex-Greater China regions, we have not relied on or used — and do not
intend to rely on or use — any data generated from Innovent’s or other third parties’ clinical
studies of the same combination therapy in China.
Merck Agreement
On June 30, 2022, we entered into a clinical trial collaboration and supply agreement (the
“Merck Agreement ”) with Merck Healthcare KGaA in relation to the clinical development of
the GFH925/cetuximab combination therapy for a Phase Ib/II clinical trial (i.e.,
GFH925X0201) in the EU.
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Obligations and Responsibilities
According to the Merck Agreement, Merck is obligated to provide cetuximab for the use
in the clinical trial to us with a maximum number of 3,500 vials and schedule specified in the
Merck Agreement according to the clinical trial status and subject to mutual agreement
between Merck and our Company. Our Company shall bear all other costs associated with the
subject clinical trial. The Merck Agreement does not affect our status as the sole sponsor of or
our sole responsibility to conduct the KROCUS trial. The Merck Agreement does not provide
for a joint steering committee. Each party agreed to customary indemnification to the other
party in relation to losses attributable to such party’s product and, in case of Company, arising
from the trial of GFH925/cetuximab combination therapy.
In addition, the Merck Agreement provides that: (1) we shall be the sponsor of the
KROCUS study and shall own and hold the respective clinical trial application for the
KROCUS study; (2) we shall ensure that all directions from any regulatory authority and/or
ethics committee with jurisdiction over the KROCUS study are followed; (3) we shall lead all
discussions with any regulatory authority regarding the KROCUS study; (4) we and Merck are
responsible for the supply of GFH925 and cetuximab, respectively, to be used in the KROCUS
study; (5) the inventions solely relating to GFH925 or cetuximab shall be solely owned by us
or Merck, respectively.
Intellectual Property
The Merck Agreement stipulates that all rights to all inventions that are directed to the
GFH925/cetuximab combination therapy and variants thereof, except those inventions solely
relating to GFH925 or cetuximab, shall be jointly owned by Merck and our Company (the
“Joint Invention ”). Those inventions solely relating to GFH925 or cetuximab shall be solely
owned by GenFleet or Merck, respectively. The Merck Agreement allows us to freely exploit
such joint inventions and does not provide for payment obligations in connection with any
licensing arrangement. Where a license is required, Merck grants to us a perpetual, irrevocable,
non-exclusive, worldwide, royalty-free, fully paid-up license under Merck’s right, title and
interest in and to all joint inventions to use such inventions for any use, and vice versa. The
Merck Agreement granted us the first right (but not the obligation) to file, maintain and defend
the patents that cover the joint inventions. However, if we do not want to file or share expenses
for a patent application that covers the joint inventions, Merck may at its own expenses
continue to file, maintain and defend such a patent application. Also, under the Merck
Agreement, we need Merck’s consent in making disclosures to the patent authority regarding
jointly inventions. The Merck Agreement does not otherwise affect our existing ownership of
intellectual property rights over GFH925. As of the Last Practicable Date, neither party has
obtained any patent or filed any patent application for the joint inventions under the Merck
Agreement. We will be the sole marketing authorization holder for the combination therapy of
GFH925/cetuximab in all Ex-Greater China jurisdictions.
The Merck Agreement further provides that, where a license is required, Merck grants to
us a perpetual, irrevocable, non-exclusive, worldwide, royalty-free, fully paid-up license under
Merck’s right, title and interest in and to all the Joint Inventions to use the Joint Inventions for
any use, and vice versa.
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Dispute Resolution
Merck and we agreed to attempt in good faith to settle all disputes arising out of the
Merck Agreement in an amicable manner. If such disputes cannot be so resolved, they shall be
finally settled at the competent courts of Geneva, Switzerland. We did not have an unresolvable
dispute with Merck during the Track Record Period.
Termination Clauses
The term of the Merck Agreement shall continue until completion of all of the obligations
of the parties or termination by either party. Either party may terminate the Merck Agreement
(i) when the other party commits a material breach and fail to remedy in a specified period, (ii)
when the party reasonably determines in good faith, after a review of relevant information, that
the trial may unreasonable affect patient safety, (iii) by providing written notice in specified
events, including regulatory action or manufacturing or supply chain disruption, (iv) by
providing advance written notice in case the study fails to reach any of its endpoints. Merck
may terminate the Merck Agreement if it reasonably and in good faith believes that the
supplied cetuximab is being used in the trial in an unsafe manner or there is imminent danger
to patients, and we fail to promptly incorporate appropriate changes to address such issues after
we receive notification from Merck.
Collaboration and Option Agreement with Verastem
On August 24, 2023 (the “ Verastem Effective Date ” referred to below), we entered into
a Collaboration and Option Agreement (the “ Verastem Agreement ”) with V erastem. V erastem
specializes in developing treatment for cancers and is a member of Nasdaq Biotechnology
Index. V erastem is an Independent Third Party to us.
Obligations and Responsibilities
Under the V erastem Agreement, we granted V erastem exclusive options (the “ Verastem
Option(s) ”) to obtain an exclusive (including us), royalty-bearing and sublicensable licenses
to develop, manufacture, commercialize and otherwise exploit the certain compounds and
products (with details below) in territories other than Mainland China, Hong Kong, Macau and
Taiwan (the “ Greater China ”) (such territories, the “ Verastem Territories ”). As the V erastem
Agreement implicates three programs, V erastem obtained three V erastem Options from us, and
the exercise of such options is on a program-by-program basis. V erastem may exercise the
option for a program within 45 days after we provide V erastem a package of documents or
information related to the products and compounds in connection with the program. As of the
Latest Practicable Date, Genfleet had not yet generated the documents or information related
to the products and compounds in connection with our collaboration with V erastem under the
V erastem Options. In January 2025, V erastem exercised the option to acquire an exclusive
license to develop and commercialize GFH375 in territories outside of Greater China. In the
same month, V erastem made a payment of US$6 million of the option exercise fee in
connection with V erastem’s exercise of the option regarding GFH375 to us, pursuant to the
V erastem Agreement.
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In connection with the V erastem Options, we agree to collaborate with V erastem to
advance three oncology collaboration programs focused primarily on RAS pathway-driven
cancers, including (i) the initial program targeting KRAS G12D, including GFH375, (ii) the
first additional program, and (iii) the second additional program (each a “ Collaboration
Program ”), provided that both the first and second additional programs target specific
molecules other than KRAS G12D (the “ Two (2) Additional Programs ”) to be selected by
V erastem. The Two (2) Additional Programs are not related to our Core Products and are not
included in our pipeline chart as they are currently in the preclinical stage. As of the Latest
Practicable Date, the Two (2) Additional Programs had been selected.
The V erastem Agreement established a JSC, to coordinate and oversee the discovery and
development activities under the agreement. We and V erastem shall each appoint an equal
number of (at least three for each party) employee representatives to the JSC. A representative
of either V erastem or us will serve as the chairperson of the JSC, with such chairperson
alternating between V erastem and us on an annual basis. The first chairperson will be a
representative of V erastem. The JSC holds meetings at least once a quarter and at other times
as the JSC may determine. All decisions within the JSC must be made on a consensus basis.
If the JSC encounters a deadlock on a matter and cannot make a decision, the matter may be
referred to the parties’ Executive Officers (i.e., our Chairman and V erastem’s Chief Executive
Officer) to negotiate and decide. If the parties’ Executive Officers still cannot resolve the
matter, then V erastem shall have the final decision-making authority for matters covered by
exercised V erastem Options outside Greater China (meaning, in the case of GFH375, the
development and commercialization of GFH375 in territories outside of Greater China), and
we shall have the final decision-making authority for matters within Greater China or not
covered by any exercised V erastem Option. If such matter is covered by an exercised V erastem
Option and relates to both Greater China and regions outside Greater China, then such matter
can only be resolved by unanimous agreement by the parties.
The V erastem Agreement provides for allocation of responsibilities between the parties
for the costs incurred in connection with activities under a Collaboration Program.
Intellectual Property
Each party will retain all of its rights, title, and interests in and to all know-how, patent
rights, and other intellectual property rights that are controlled by such party prior to the
V erastem Agreement or are otherwise conceived, discovered, developed, invented, created, or
otherwise made or acquired by such party or its affiliates outside of the performance of
activities under the V erastem Agreement, subject to any rights or licenses expressly granted by
such party to the other party under the V erastem Agreement. Subject to any rights or licenses
expressly granted to V erastem, we are the sole owner of all collaboration knowhow and patent
rights first generated, conceived, discovered, created, invented, or otherwise made during the
term solely by or on behalf of us during the performance of activities under the V erastem
Agreement. Subject to any rights or licenses granted to us, V erastem is the sole owner of all
collaboration knowhow and patent rights first generated, conceived, discovered, created,
invented, or otherwise made during the term solely by or on behalf of V erastem during the
performance of activities under the V erastem Agreement. Subject to any rights or licenses
granted by one party to the other party, the parties will jointly own all Joint Collaboration
Technology on an equal and undivided basis.
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In addition, we have an obligation to indemnify V erastem the potential penalties arising
from patent infringement of IP claims asserted by a third party outside Greater China.
Payments
According to the V erastem Agreement, V erastem agreed to make an upfront payment of
US$5.0 million in two installments and will provide US$1.5 million of research support over
the first three years of the V erastem Agreement. In addition, pursuant to the V erastem
Agreement, upon achievement of pre-specified development milestones triggered by certain
clinical development progress and regulatory filing regarding GFH375 and commercial
milestones triggered by reaching annual sales of at least hundreds of millions of U.S. dollars
per year, and upon V erastem exercising all three V erastem Options, we will be entitled to
receive payments (evenly split among the three V erastem Options) of up to US$620.0 million
inclusive of (i) US$6.0 million upon exercise of each of the three (3) GenFleet Options, (ii)
US$2.0 million of pre-option development milestone payment for each of the Two (2)
Additional Programs, (iii) up to US$49.0 million upon achievement of pre-specified
development and commercialization milestones for each of the three (3) licensed programs,
(iv) up to US$150.0 million upon achievement of pre-specified sales milestones for each of the
three (3) licensed programs, and (v) up to US$1.0 million for the manufacture of licensed
compound and licensed products. V erastem has also agreed to pay us royalties on annual net
sales (determined in accordance with U.S. GAAP) of licensed products in the V erastem
Territories ranging from the mid to high single digits. If V erastem grants a sublicense for either
of the Two (2) Additional Programs to a third party in the United States, European Union
(including the United Kingdom) or Japan, V erastem will pay us a percentage ranging from a
middle single-digit to a low double-digit percentage of any upfront payment.
As of the Latest Practicable Date, we had received the full upfront payment of US$5.0
million, the first annual R&D fee payment of US$0.5 million from V erastem and US$6.0
million revenue related to GFH375 in connection with V erastem’s exercise of its option under
the V erastem Agreement in January 2025.
Dispute Resolution
For any dispute between the parties, other than matters subject to resolution by the joint
steering committee established by the parties, the parties will first attempt in good faith to
resolve such dispute by negotiation. If the dispute is not resolved informally within 10 days,
either party may refer the matter to the executive officers of the parties for resolution. The
executive officers will then attempt in good faith to resolve the dispute through negotiation
within 10 business days following the referral. If the dispute remains unresolved, a party may
submit the dispute to arbitration by providing written notice to the other party. Within 30 days
after receipt of such notice, the parties shall designate a single arbitrator in writing. If the
parties cannot agree on an arbitrator within that 30-day period, the arbitrator shall be selected
by the Singapore office of the American Arbitration Association-International Centre for
Dispute Resolution. The arbitration shall be governed by the International Arbitration Rules
and Procedures of the International Centre for Dispute Resolution. The V erastem Agreement is
governed by, and enforced and construed in accordance with, the laws of the state of Delaware,
without regard to its conflicts of law provisions.
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Termination Clauses
V erastem may terminate the V erastem Agreement in its entirety or on a program-by-
program basis or on a licensed product-by-licensed product and country-by-country basis, by
providing 90 days written notice to us
5. Either party may terminate the V erastem Agreement
in its entirety or on a program-by-program and country-by-country basis, with 60 days’ written
notice for the other party’s material breach if such party fails to cure the breach. Either party
may also terminate the V erastem Agreement in its entirety upon the following insolvency
events by the other party: (a) files for bankruptcy; (b) making an assignment for the benefit of,
or an arrangement or composition generally with, its creditors; (c) appointing an examiner of
or a receiver or trustee over all or substantially all of its property or suffering the appointment
of such party that is not discharged within 60 days after such filing or appointment; (d)
proposing a written agreement of composition or extension of its debts; (e) proposing or being
a party to any dissolution, liquidation or winding up; (f) having a bankruptcy petition filed
against it that is not discharged or dismissed within 60 days, or (g) admitting in writing its
inability generally to meet its obligations as they fall due in the ordinary course.
License Agreement with SELLAS
On March 31, 2022 (the “ SELLAS Effective Date ” referred to below), we entered into
a License Agreement (the “ SELLAS License Agreement ”) with SELLAS. SELLAS
specializes in developing novel therapeutics for a broad range of cancer indications including
hematological malignancies and solid tumors. SELLAS is an Independent Third Party to us.
Obligations and Responsibilities
Under the SELLAS License Agreement, we grant SELLAS an exclusive (even as to us),
sublicensable, royalty-bearing right and license under relevant patents and know-how
controlled by us to develop, manufacture and commercialize GFH009 and any related back-up
molecules or intermediaries, or related compound or forms as specified in the SELLAS License
Agreement, across all treatment, diagnosis, or prevention of disease in humans and animals
uses in regions outside of Greater China (Mainland China, Hong Kong, Macau and Taiwan).
SELLAS shall have sole responsibility for the cost and expense of, and the sole authority over
and control of the development, manufacture, regulatory approval, and commercialization of
the compounds and products, including GFH009, outside of Greater China.
Under the SELLAS License Agreement, the parties will establish a JSC to review and
oversee the development and commercialization of the compounds and products, including
GFH009, and to coordinate the parties’ activities under the SELLAS License Agreement. Each
party shall appoint two representatives to the JSC and designate a co-chairperson from their
representatives. The purpose of the JSC is only for the exchange of information and discussion.
5 The expression of to “continue/terminate/expire” something on a “product-by-product,” “program-by-program,”
“region-by-region” and “country-by-country” basis means: whether something is to continue/terminate/expire is
determined separately for each particular product, program, region, or country. Here, the expression indicates that
the V erastem Agreement may be terminated only as to a particular product, program, or country, while remaining
effective as to a different product, program, or country.
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The JSC has no decision-making authority. SELLAS has final decision-making authority for all
matters relating to the development and commercialization of the compounds and products,
including GFH009, outside of Greater China. The JSC will hold meetings on a semi-annual
basis determined reasonably by the co-chairpersons.
Intellectual Property
Each party shall retain all rights, title and interests in and to any intellectual property
rights that it owned, licensed or sublicensed prior to or independent of the SELLAS License
Agreement. Ownership of patent rights created or developed under the SELLAS License
Agreement after the SELLAS Effective Date and during the term will be determined based on
inventorship, with inventorship being determined according to the principles of United States
patent law.
Payments
According to the SELLAS License Agreement, SELLAS is obligated to provide us with
the following payments: (i) a non-refundable, and non-creditable initial payment of US$10.0
million; (ii) development and regulatory milestone payments of an aggregate of up to US$48.0
million upon the achievement of the following milestones: the first dosing of the first subject
in the first Phase III clinical trial, application and subsequent regulatory approval of an NDA
with the FDA or EMA for the first indication, the second indication and the third indication;
and (iii) the sales milestone payments of an aggregate of up to US$92.0 million upon the
achievement of specific levels of the aggregate annual net sales. In addition, SELLAS shall pay
us non-refundable, non-creditable royalties at rates ranging from a low single-digit percentage
to a high single-digit percentage based on the aggregate net annual sales, calculated on a
product-by-product and country-by-country basis. The royalties will be payable during the
Royalty Term under the SELLAS License Agreement (as defined below). Net sales shall be
calculated by gross amount invoiced, less applicable discounts, shipping charges, and taxes as
well as other customary adjustments. Net sales shall be determined in accordance with U.S.
GAAP .
As of the Latest Practicable Date, we had received the full initial payment US$10.0
million from SELLAS.
Dispute Resolution
For any dispute regarding the construction of the SELLAS License Agreement or the
rights and liabilities of either party, the parties will first attempt in good faith to resolve the
dispute through negotiation. If the dispute is not resolved informally within 10 business days,
either party may, by written notice to the other party, refer the dispute to an executive officer
of the other party for attempted resolution through good faith negotiation within 30 days after
such notice is received. If the dispute remains unresolved, it shall be submitted in writing to
the other party for arbitration at the office of the American Arbitration Association in New Y ork
County, New Y ork, U.S., in accordance with the then-prevailing commercial arbitration rules
of the American Arbitration Association.
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Termination Clauses
The term of the SELLAS License Agreement shall commence on the SELLAS Effective
Date and shall continue, on a product-by-product and country-by-country basis, until the
expiration of the applicable Royalty Term under the SELLAS License Agreement, unless
earlier terminated. The Royalty Term under the SELLAS License Agreement is determined on
a product-to-product and country-to country basis, defined as: since the first commercial sale
the GFH009 product in a country, until the later of: (a) ten years following the date of such first
commercial sale, or (b) the date upon which the manufacture, use, sale, offer for sale, or
importation of such product in such country would no longer infringe, but for the license
granted by the SELLAS License Agreement, a valid claim of our patents. Upon the expiration
of the Royalty Term on a product-by-product and country-by-country basis, the license granted
to SELLAS shall become non-exclusive, perpetual and fully paid up on a product-by-product
and country-by-country basis.
Each party may, without prejudice to any other remedies available to it at law or in equity,
terminate the SELLAS License Agreement in its entirety if the other party materially breaches
any material obligations and fails to cure such material breach within 90 days of receiving
notice. SELLAS may terminate the SELLAS License Agreement for the following conditions:
(i) with 180 days’ prior written notice if a clinical failure occurs during the period from the first
anniversary of the SELLAS Effective Date until the first regulatory approval of the product in
any country outside of Greater China; (ii) with one year’s prior written notice upon receiving
the first regulatory approval of the product and continuing through the end of the Term; (iii)
upon 90 days’ notice if there is a material risk for harm in humans or if the occurrence of any
safety concerned required to be reported that results in a clinical hold issued by the FDA, or
if there is a material toxicity or material drug safety issues or serious adverse event reasonably
related to GFH009 that was not publicly known at the time of the SELLAS Effective Date; or
(iv) upon notice if we file a petition under any bankruptcy or insolvency act or makes an
assignment for the benefit of creditors or has any other events of insolvency as specified in the
SELLAS License Agreement. We may terminate the SELLAS License Agreement by delivery
of written notice under the following circumstances: (i) if SELLAS fails to make the required
payment within 60 days after the receipt of our written notice; (ii) if SELLAS fails to meet the
deadline for a diligence milestone event including but not limited to the first dosing of a first
patient in Phase II clinical trial within 12 months following completion of Phase I trial for such
product; or (iii) if SELLAS files a petition under any bankruptcy or insolvency act or make an
assignment for the benefit of creditors or has any other events of insolvency as specified in the
SELLAS License Agreement.
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Supplementary Agreement with SELLAS
On October 13, 2022 (the “ SELLAS Supplementary Effective Date ”), we further
entered into a clinical supply agreement supplement to the SELLAS License Agreement (the
“SELLAS Supplementary Agreement ”) with SELLAS.
Obligations and Responsibilities
According to the SELLAS Supplementary Agreement, we have appointed two leading
CDMO companies for the manufacturing of API and drug product of GFH009, respectively,
and we shall supply GFH009 in the applicable formulations as specified in each purchase order
to SELLAS as a non-exclusive supplier. We will ensure that we deliver GFH009 in
conformation with the specifications, and regulatory standards (the “ Manufacturing
Requirements ”). SELLAS will provide a purchase order to us every six months, specifying the
quantity, formulations, and requested delivery dates. SELLAS retains a right to inspect the
shipment and return or destroy any products that do not conform to the Manufacturing
Requirements (the “ Non-conforming Product ”), at our option and our costs and expenses. We
will then (a) at SELLAS’s election, either promptly (i) deliver replacement to SELLAS at our
cost, or (ii) reimburse SELLAS for all amounts already paid to us for such Non-conforming
Product; and (b) reimburse SELLAS for shipping costs for the delivery of Non-conforming
Product.
Payments
SELLAS will pay us a per unit price for the clinical supply of GFH009 equal to the fully
burdened manufacturing cost per unit, plus a percentage of our FTE cost for manufacturing
management (the “ Supply Price ”). However, excluding inflation, the Supply Price will not
exceed a specified amount per vial within three years following the effective date of the
supplementary agreement with SELLAS.
Upon receipt of a purchase order, SELLAS will pay us a portion of the Supply Price,
along with any applicable taxes as outlined in the purchase order. Upon delivery of the first
shipment of GFH009, SELLAS will pay us the remaining balance of the Supply Price and
applicable taxes as specified in the purchase order.
As of the Latest Practicable Date, we had received US$0.2 million under the SELLAS
Supplementary Agreement.
Dispute Resolution
The dispute resolution mechanism of the SELLAS License Agreement shall also apply to
the SELLAS Supplementary Agreement.
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Termination Clauses
The term of the SELLAS Supplementary Agreement will commence on the SELLAS
Supplementary Effective Date and continue until SELLAS no longer develops GFH009 in
countries outside of Greater China.
The SELLAS Supplementary Agreement will terminate (i) upon termination of the
SELLAS License Agreement, or (ii) upon either party filing for bankruptcy proceedings. In the
event of a material breach of the SELLAS Supplementary Agreement by SELLAS, we have the
right to terminate the agreement by providing 30 days’ written notice to SELLAS. Furthermore,
SELLAS may terminate the SELLAS Supplementary Agreement (i) for convenience, by
delivering written notice to us at least 60 days prior to the effective termination date, or (ii)
in the event of a material breach by us, by providing 30 days’ written notice.
RESEARCH AND DEVELOPMENT
R&D Strategy
We aspire to leverage our industry experience and established R&D capabilities to
develop innovative and effective treatment options in the fields of oncology, autoimmune and
inflammatory diseases. During our endeavor, we have established and leveraged a proven,
integrated research and development platform spanning target discovery, molecular discovery
and evaluation, translational science and clinical development. Our technological capabilities
include discovery of original molecular structures and new molecular entities, investigation of
molecular process routes and quality standards, as well as exploration of clinical drug
combination development paths. Combining these internally accumulated capabilities and
external resources of our collaborators and service providers, we have rendered our pipeline
products among the frontrunners in both China and the global market.
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R&D Team
Our R&D team has strong expertise, deep understanding and broad development
experience. As of the Latest Practicable Date, 48 members of our R&D team had obtained
advanced degrees, including 13 members with doctorate degrees and 35 members with master’s
degrees. Our R&D team is led by a team of world-class scientists with years of drug
development experience. Our core R&D personnel consists of six members covering the fields
of chemistry, biology, pharmacology and medicine. All of our core R&D personnel have been
working in the pharmaceutical industry for over 15 years. The core R&D personnel involved
in the development of the Core Product are all remained employed by us. The following table
sets forth a breakdown of the number of R&D team by function as of the Latest Practicable
Date:
Functions
Number of
employees by
function
Early Research and Development /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111837
Clinical Development /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816
CMC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111868
The following table sets forth the identities, positions, expertise of our core R&D
personnel as of the Latest Practicable Date and their involvement and contributions to the R&D
activities, including with regard to our Core Products, up to the same date. We had not
experienced any material difficulties in our R&D activities, including the research and
development of our Core Products.
Identity Position Expertise
Involvement and
contributions to
the R&D activities,
including with regard
to our Core Products
Date of
joining our
Group
Dr. Qiang
LU /H1118/H1118/H1118/H1118/H1118/H1118/H1118
Executive
Director and
Chairman of
the Board
Over 20 years’
experience in the
biopharmaceutical
industry
Provide strategic
guidance on and
oversee our R&D
efforts
Since our
inception
Dr. Jiong
LAN /H1118/H1118/H1118/H1118/H1118
Executive
Director, Chief
Executive
Officer and
General
Manager
Over 20 years’
experience in the
biopharmaceutical
industry
Provide strategic
guidance on and
oversee our R&D
efforts
Since our
inception
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Identity Position Expertise
Involvement and
contributions to
the R&D activities,
including with regard
to our Core Products
Date of
joining our
Group
Dr. W ANG Y u /H1118Chief Medical
Officer
Over 20 years’
experience in
clinical
development
Strategize and execute
our clinical
development
November
2020
Dr. LI
Jingrong /H1118/H1118/H1118/H1118
Chief Technology
Officer
Over 20 years’
experience in the
biopharmaceutical
industry
Refine the CMC aspects
of our pipeline
products to advance
drug development,
optimize cost and
ensure consistent
quality
January
2022
Dr. SHEN
Haige /H1118/H1118/H1118/H1118/H1118
SVP , clinical
development
Over 15 years’
experience in drug
and clinical
development
Design and oversee our
clinical development
programs
November
2020
Dr. ZHOU
Fusheng /H1118/H1118/H1118/H1118
VP , drug
discovery
Over 15 years’
experience
in drug
development
Supervise our preclinical
research and
development activities,
in particular early drug
discovery efforts
April 2018
Drug Discovery
As of the Latest Practicable Date, there were 37 members in the drug discovery function
of our Company, who are divided to sub-functions that focus on biology, chemistry, drug
metabolism and pharmacokinetics, pharmacology, toxicology, large molecule R&D, project
management, computational chemistry, as well as patent information. Each sub-function is
directed by a function lead. Most of the team members hold an advanced degree in the relevant
fields. The function head typically have over 10 years of experience, while our laboratory staff
generally have 5 years or more of experience.
Our Platforms
We have established and leveraged a proven, integrated research and development drug
discovery and development system spanning target discovery, molecular discovery and
evaluation, translational science and clinical development. Our technological capabilities
include discovery of original molecular structures and new molecular entities, investigation of
molecular process routes and quality standards, as well as exploration of clinical drug
combination development paths. These research and development capabilities organically
constitute our drug development framework, which enables us to efficiently advance pipeline
programs through different developmental stages.
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Target Discovery Platform
The target discovery platform is rooted in our endeavor to develop differentiated
therapeutic options based on clinical needs. We focus on addressing clinical needs by analyzing
disease-related factors such as geographical variations, underlying biological mechanisms,
primary or secondary drug resistance, and the specifics of medical treatment modalities. We
also consider the mechanisms of drug action and the global clinical strategy landscape. By
analyzing literature and ongoing research in the field, we are able to identify and prioritize
novel and potentially druggable targets. After integrating insights from the developments and
future projections of the industry as a whole, our target discovery platform crafts differentiated
clinical development strategies tailored to specific disease contexts and therapeutic areas.
Molecular Discovery and Evaluation Platform
The molecular discovery and evaluation platform is a critical component in our new drug
development process, which is designed to enhance the efficiency and success rate of our drug
discovery efforts. The platform includes integrated molecular design, synthesis and
optimization technology, high-quality molecular discovery, efficient drug metabolism and
pharmacokinetics research technology, comprehensive biological and drug mechanisms
evaluation technology, which together not only accelerate the molecular investigation phase
but also significantly increase the likelihood of successful drug development.
With our molecular discovery and evaluation platform, we have been able to explore
versatile technologies and modalities to address challenging targets identified by our target
discovery platform. For instance, in addition to traditional small molecule drug and antibodies,
we are also developing molecular glue and bioconjugates, which are functional antibody
synergistic conjugate (FAScon) that aim to realize both precise targeting and synergistic effects
of the large and small molecules. With this platform, we also designed a special linker featuring
adequate stability to prevent premature release of payload in the blood and enabling
conjugation of hydrophobic small molecules at a high drug-to-antibody ratio.
In parallel to our molecular discovery and evaluation platform, we believe that the
in-depth CMC experience over the years forms an integral part of our drug discovery efforts.
For additional information about our CMC capabilities, see “— Chemistry, Manufacturing and
Controls (“ CMC”).”
Translational Science and Clinical Development Platform
We seamlessly integrate our early-stage drug discovery activities with later clinical
development capabilities. For instance, our early-stage drug discovery platforms enable
generation of solid preclinical candidates with optimized design and promising IND-enabling
result to facilitate advancement of clinical development, and our clinical development
activities may help us refine parameters that we focus during drug discovery efforts. Our
translational science and clinical development platform encompasses our biomarker clinical
translation technology, precision medicine technology for the entire project lifecycle, clinical
development technology based on data science and quantitative analysis. For additional
information about our clinical development capabilities, see “— Clinical Development” below.
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External Collaboration
For our preclinical studies, we have collaborated with global CROs and leading research
institutes for preclinical development. These partners and collaborators mainly provide us with
services related to protein purification, establishment of enzymatic assay, cocrystallization of
compounds with target proteins, preclinical toxicity and safety evaluations of our product
candidates in accordance with agreed study design and under our supervision. We select our
collaborators to facilitate our innovative strategy.
Clinical Development
Clinical Development Team
As of the Latest Practicable Date, our clinical development team consisted of 16
members, including scientists and physicians with strong drug development experience, who
participate in clinical development strategy development, clinical trial design, clinical trial
operation organization, drug safety monitoring, and clinical trial quality control. Many of our
clinical development team members had extensive relevant work experience. Among our
clinical development team members, over 60% have obtained post-graduate degrees. Our
clinical development team is generally responsible for the clinical development of our Core
Products and other pipeline products.
Clinical Trial Design and Implementation
Our clinical development team manages all stages of clinical trials, from protocol design
to overseeing the operations and conduct of clinical trials. Our rapid trial advancements are
driven by (i) our strategic decision to initiate clinical phase trials based on preclinical results
that are assessed as promising, (ii) optimized trial design, enabled by our rigorous quantitative
analysis of integrated data, and whole-process oversight, and (iii) long-term partnership with
various hospitals and principal investigators from different regions to achieve smooth
execution. For pipeline products that are out-licensed to third parties in certain jurisdictions,
our clinical development team also keeps track of their clinical development in those
jurisdictions and participates in the analysis of clinical results and provides suggestions as
needed.
Our clinical development team is also responsible for the selection of trial sites. Our site
selection criteria include the site’s overall experience, understanding of the disease state,
access to relevant experts and patients, geographical coverage, regulatory and quality
management, range of services, staff proficiency, and technology. We have collaborated with
numerous hospitals and PIs located in China and overseas that can support our clinical trials
of different indications, at different stages and in different jurisdictions. We believe the size
and geographic diversity of these facilities provide us with an advantage in implementing
large-scale clinical trials in and out of China and also enable us to conduct multiple clinical
trials concurrently. With the support of our partner hospitals, we are capable of recruiting
participants from specific populations for trials that would otherwise be difficult to fulfill
enrollment.
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For the years ended December 31, 2023 and 2024, we cooperated with 116 and 122 PIs,
respectively, to conduct the clinical trials of our product candidates. To the best of our
Company’s knowledge, none of them has any past or present relationships with our Group, our
Directors, shareholders, senior management or any of their respective associates. The PIs are
responsible for conducting site-level clinical research activities according to our trial protocols
and in accordance with laws, regulations, and the GCP Guideline, a quality standard for the
overall conduct of the clinical trial. Each trial has a leading PI with primary responsibility to
ensure compliance with trial protocol and good clinical practice over the entire trial.
Relationship with CROs
We collaborate with CROs to conduct and support our preclinical and clinical trials in line
with industry practice. We select our CROs by weighing various factors. Upon business
engagement, we assess CROs based on their business focus, capabilities and overall market
recognition. Secondly, we also value the R&D capabilities of the CROs and the management
skills of their leaders based on their experience and previous track record. Overall, we aim to
select CROs that have optimal compatibility with our preclinical and clinical development
programs. When collaborating with CROs on a given project, our internal project team takes
a comprehensive approach to manage such project and closely monitors the progress, engages
in regular communication with the CRO teams to understand project milestones, identify
potential risks, and ensure the project deliverables. Simultaneously, the project/trial leader
maintains close contact with the financial departments of both our Company and the CRO
organization, implementing stringent financial controls at different stages of the project to
ensure its timely and quality completion. Upon project completion, we will conduct a thorough
review and provides feedback to enhance the efficiency of future collaborations with the CRO
organizations.
The clinical CROs provide us with an array of services necessary for complex clinical
trials in accordance with agreed trial design and under our supervision, including trial
preparation, trial management, clinical safety management, data management, and report
preparation. We choose to engage a CRO based on the complexity and workload of a specific
trial. Led by Dr. Shen (our SVP for clinical development), we have a designated team to
oversee the on-the-ground operations of clinical trials implemented by CROs at different
locations. We closely monitor the work of our CROs and provide specific directions to ensure
the quality and efficiency of the trial execution. This approach allows us to leverage the
experience of our in-house team to better focus on critical clinical trial elements, such as trial
design, data analysis and decision-making. All studies of our product candidates on humans are
conducted in compliance with the applicable laws, regulations and in line with the industry
standards. We believe our ability to conduct and work closely with CROs to conduct preclinical
studies and clinical trials helps us to shorten the time required for product development as well
as generate the requisite data in a reliable and efficient way.
We mainly determine the service fees paid to the CROs in accordance with market prices
of similar services, the number of enrolled patients, the duration of the clinical trials, the
complexity of trial, including the number of clinical sites and jurisdictions, and the quality and
contents of the services provided.
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Regulatory Affairs
Our regulatory affairs team is responsible for the regulatory process of our product
candidates, including assembling application dossiers for IND and NDA, addressing inquiries
from relevant authorities and monitoring our R&D projects to ensure their compliance with
relevant regulations. Our regulatory affairs team manages the regulatory submission process in
multiple major jurisdictions, including China, the U.S., Europe, and Australia, for our product
candidates, which requires filings to be made to and approved by the relevant authorities before
clinical trials and commercialization can be initiated. The regulatory affairs team prepares and
manages regulatory filings by coordinating filing dossiers drafting, addressing regulatory
questions and conducting CMC and GMP readiness assessments for our product candidates. We
possess extensive knowledge and experience with regard to regulatory filings in China and
overseas. With our presence and expertise in China and overseas jurisdictions, we can design
our clinical trials to maximize operational efficiency.
CHEMISTRY, MANUFACTURING & CONTROLS (“CMC”)
CMC Team
As of the Latest Practicable Date, our CMC team consisted of 15 professionals with
extensive experience in process development, production and quality management from
well-known biopharmaceutical and pharmaceutical companies. Our CMC team members have
on average approximately 11 years’ experience. Our CMC team is specialized in preclinical and
clinical support throughout the drug development process. The CMC function in our Company
plays a critical role in drug development. It is responsible for developing safe, robust, and
economically sound production processes for our drug substances and drug products, and
ensuring their quality meets regulatory requirements.
We have established CMC capabilities that cover key aspects from the design of synthetic
routes for preclinical candidates to process development and quality control in clinical
development. We have in-depth expertise in areas including small molecule process
development, dosage form selection, formulation determination, formulation process
development, drug quality control strategies, development and validation of quality control
methodologies, non-GMP kilogram-scale pilot production, and NDA-stage process validation.
In particular, the capabilities of our CMC team are reflected in the following aspects.
First, our CMC team designs and develops production processes, including but not limited to
process route design, process parameter reaction condition development and production-scale
setting. In the process development for GFH925, our CMC team designed the process route and
validated the same at the kilogram scale in its Shaoxing research facility. Our CMC team then
transferred the technology on production processes of GFH925 to the CDMOs to validate and
implement the process route at a commercial scale. Second, our CMC team designs and
develops quality control methods and then transfers the technology on quality control to the
CDMOs to validate the method and set the quality standard. Third, our CMC team manages the
CDMOs it collaborates with. Our CMC team not only monitors the CDMOs’ work progress but
also offers solutions to the CDMOs when a technical problem arises. Through collaboration,
our CMC team helps the CDMOs improve their technical, compliance, and research
capabilities.
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Our CMC functions facilitate a smooth drug development and enables cost control. In
particular, we develop suitable process and ensure quality control according to applicable drug
registration regulations at early stages of product development. This strategy enables us to
avoid detours in subsequent development stage resulted from CMC issues that could have been
addressed earlier in the process, therefore may improve the overall efficiency of our research
and development efforts. In addition, our CMC process development capabilities allow us to
device efficient synthetic routes and establish measures to ensure consistent and reliable
production, thereby contribute to cost control and efficient use of resources. We are able to
significantly lower the manufacturing cost of GFH925 by optimizing the process route, and we
believe our strong CMC expertise also facilitated GFH925 to receive marketing approval in
China in merely approximately three years after it obtained IND approval. We are also actively
developing the second-generation manufacturing process for GFH925, taking full
responsibility for the entire process, including vendor selection. We have engaged two vendors
to collaborate on this initiative. The vendors are two leading CDMOs in China that have passed
multiple rounds of on-site inspections by the NMPA and the FDA. By April 2025, the two
vendors have completed process qualification and control, as well as method qualification and
control, for the second-generation manufacturing process; and their applications for
manufacturing license have been submitted to and pending before the competent authorities in
China. We anticipate that the second-generation manufacturing process will significantly
enhance the cost-efficiency of drug production. The second-generation manufacturing process
adopts low-cost starting materials, applies chiral response surface methodology, and optimizes
the sequence of process steps. These enhancements have led to lower production costs and
higher recovery yields, thereby laying a strong foundation for future scale-up of
manufacturing. Compared with the first-generation manufacturing process, the second-
generation manufacturing process is expected to generate products of the same quality while
achieving over 50% of cost reduction. We are the sole owner of the knowhow or invention
generated from second-generation manufacturing process of GFH925. We believe that
possessing core competency in CMC expertise will enable us to ensure the safety and quality
of the drug supply while positioning us to independently pursue ex-China regulatory approvals
and capitalize on potential commercial opportunities for GFH925 once the necessary
regulatory milestones are obtained.
Collaboration with CDMO Partners
As of the Latest Practicable Date, we did not have in-house manufacturing facility. We
currently plan to establish our own manufacturing facilities to support the formulation
production of certain of our pipeline products. We plan to establish a finished dose
manufacturing facility in Zhejiang Province, the PRC. Although we are advancing the
second-generation manufacturing process for GFH925, we plan to continue to engage CDMOs
for the manufacturing of the active pharmaceutical ingredient of GFH925 and fulfill our drug
supply responsibility of GFH925 in the future, and we will no longer reserve manufacturing
capacity for this product. We believe the capacity of the contracted CDMO service providers
is sufficient to satisfy our needs.
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Over the next three years, we expect our Core Product, GFH375, will enter into
commercialization stage and require the use of our in-house manufacturing facility, which has
a designed annual capacity of 100 million tablets. As of the date of this prospectus, we do not
have plan to use our in-house manufacturing facility for other clinical assets. The area of the
manufacturing facility is expected to be around 5000m
2. The manufacturing facility is expected
to include manufacturing lines for oral solid dose, tablet and capsule with a designed capacity
of hundred million pieces, and a liquid dose manufacturing line. The planned timeline for the
construction of the manufacturing facility is as follows: determination of the location by the
end of 2025; completion of construction and equipment purchase by September 2026;
completion of plant commissioning and technology transfer, and initiation of trial operation of
the facility by the end of 2026; commencement of commercial-scale production by the end of
2028. We collaborate with CDMOs to conduct and support our preclinical and clinical trials in
line with industry practice. In terms of the involvement and contributions of each of the major
CDMO partners to the development of our product candidates, we collaborate with our CDMO
partners to manufacture certain raw materials and drug substances, such as the active
pharmaceutical ingredients (“ APIs ”) of our product candidates to supply for preclinical studies
and clinical trials. We believe the capacity of the contracted CDMO service providers is
sufficient to satisfy our needs.
For instance, we are the manufacturer and supplier of GFH925 in connection with the
collaboration with Innovent. To support this supply arrangement, we independently developed
a suitable and scalable manufacturing process for GFH925, including robust quality control
protocols. We do not manufacture the active pharmaceutical ingredient (“ API”) in-house;
rather, we engage a reputable and qualified CDMO to produce the API according to our
proprietary process and specifications. We maintain oversight of the production process and
ensures the continuous, compliant, and high-quality supply of the API.
Once the API is manufactured and released, Innovent is responsible for engaging its own
downstream vendor to formulate and manufacture the finished drug product using the API
supplied by us. This division of responsibility ensures efficiency, cost control, and regulatory
compliance throughout the production and supply chain for GFH925.
We did not experience any material product quality issues in respect of the products
manufactured by our CDMO partners during the Track Record Period. Under our agreement
with our CDMO partners, the CDMO partners are required to perform their services according
to the prescribed time frame as set out in the agreement. Usually, we pay the CDMO partners
in installments, with a specified credit period. Our CDMO partners are responsible for
manufacturing our required products in accordance with certain product specifications, in
compliance with cGMP requirements (where applicable), our quality standards and other
applicable laws and regulations. We retain all the intellectual property rights and grant our
CDMO partners the right to use our intellectual property rights for such manufacturing and
packaging activities during the contract period. We are entitled to inspect and audit our CDMO
partner’s manufacturing process. We mainly determine the service fees paid to the CDMOs in
accordance with market prices of similar services, the number of products manufactured, and
the quality and contents of the services provided. We do not share our IPs, know-hows and
trade secrets with CDMOs.
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BUSINESS DEVELOPMENT
To maximize the commercial potential and improve the development efficiency of our
pipeline products, we actively pursue diversified global business development opportunities. In
the past, we collaborated with Innovent to facilitate the swift development and approval of
GFH925 for commercialization in China. This collaboration leveraged Innovent’s strong
development expertise in advancing clinical trials, as well as their leadership position in China,
which includes an established commercialization team and an extensive marketing network.
We also forged collaborations with SELLAS, which has significant expertise in hematological
malignancies and solid tumors, on GFH009, a small molecule selective inhibitor of CDK9
designed for the treatment of AML and certain lymphomas, as well as with V erastem, a
company focused on RAS pathway-driven cancers, on certain of our RAS-targeting pipeline
products. For additional information on our business development efforts, see “— Major
Collaboration and Licensing Arrangements.”
Going forward, we plan to continue establishing strategic partnerships with leading
international and domestic pharmaceutical companies to expand our geographic coverage, as
well as accelerate the development of our product candidates, with the ultimate objective to
maximize the value of our product pipeline. We will select potential collaborators based on a
number of considerations, including the brand awareness of the potential collaborators, their
R&D capabilities and/or commercialization networks, the track records of successfully develop
and/or commercialize pharmaceutical products, where applicable. We will also seek such
potential collaborators with pipelines, R&D and commercialization capabilities, as well as
monetary resources that could bring potential synergies to us and our pipelines.
In August 2024, GFH925 obtained the NDA approval from the NMPA for the treatment
of adult patients with advanced NSCLC harboring KRAS G12C mutation who have received
at least one systemic therapy. Pursuant to the GFH925 License Agreement, Innovent is
responsible for the commercialization of GFH925 in Greater China. As of the Latest
Practicable Date, none of our pipeline products for which we retain the commercialization
rights had been approved for commercialization in China or overseas. To lay a solid foundation
for our future marketing and commercialization efforts, we plan to actively engage in academic
promotions and industry seminars to familiarize market participants, such as patients,
physicians and PIs of clinical trials, regarding the potential advantages of our pipeline
products. We believe such efforts would also help us gain a favorable brand image and name
recognition, which may contribute to maximizing the commercial value of our product
portfolio. We intend to closely monitor the updates in the industry and formulate concrete
commercialization plans when we advance our pipeline programs closer to the NDA
submission stage. We will assess and select an appropriate commercialization model and may
seek external collaborations, including engaging third-party contract sales organizations, if we
deem it to serve our best interest.
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INTELLECTUAL PROPERTY
Intellectual property rights are pivotal to the success of our business. Our commercial
future will depend, in part, on our ability to acquire and protect our intellectual property rights
for commercially significant technologies, inventions and know-how. This includes acquisition
of new patents, defense of existing patents, and protection of our trade secrets. We will also
have to operate without infringing, misappropriating, or otherwise violating third parties’ valid,
enforceable intellectual property rights.
As of the Latest Practicable Date, we held 72 issued patents and 118 patent applications
(including 9 PCT applications). As of the Latest Practicable Date, we held (i) 2, 1, 1 and 8
issued patents related to GFH925 in China, the U.S., the E.U. and in other overseas
jurisdictions respectively, and (ii) 5, 4, 3, 1 and 21 patent applications related to GFH925 in
China, the U.S., the E.U., under the PCT and in other overseas jurisdictions, respectively. As
of the same date, we had not received issued patents related to GFH375, but held 2, 1, 1, 1 and
22 patent applications related to GFH375 in China, the U.S., the E.U., under the PCT and in
other overseas jurisdiction, respectively. We currently plan to file patent application related to
GFH375 in Hong Kong in the second half of 2025 and in Macau after the receipt of the issued
patent in China. As of the Latest Practicable Date, we had not received any material concerns
or inquiries from relevant competent authorities that makes us to believe that any of the
pending patent applications will be finally rejected. The following table sets forth an overview
of our material granted patents and filed patent applications in connection with our clinical and
preclinical product candidates as of the Latest Practicable Date:
Products
Name of Patent
Family (1) Jurisdiction Status
Patent
Application Grant Date
Patent
Expiration (2) Type
Owner/
Applicant Inventor (3)
GFH925 /H1118/H1118Substituted
Heterocyclic Fused
Cyclic Compound,
Preparation Method
Therefor and
Pharmaceutical Use
Thereof
China,
United
States, EPO
Granted 2020-10-28 China:
2022-8-5;
United States:
2024-8-6;
EPO:
2024-10-9
2040-10-28 Invention GenFleet,
GenFleet
Zhejiang
Fusheng Zhou,
Tao Jiang,
Chonglan Lin,
Lijian Cai,
Wan He, Jiong
Lan
China,
United
States, EPO
Pending – – Invention GenFleet,
GenFleet
Zhejiang
Polymorph of KRAS
Inhibitor,
Preparation Method
Therefor, and Use
Thereof
China,
United
States, EPO
Pending 2022-12-23 – – Invention GenFleet,
GenFleet
Zhejiang
Fusheng Zhou,
Jinzhu Zhao,
Y udong Cao,
Lun Xiong,
Rongzhen Shi,
Jiong Lan
Pharmaceutical
Composition, Use
Thereof, and
Method for Treating
Cancer
China, United
States, EPO
Pending China:
2023-03-30;
United States:
2023-03-31;
EPO:
2023-03-31
– – Invention GenFleet,
GenFleet
Zhejiang
Lili Tang, Xiang
Y u, Jingyang
Zhang,
Huizhong Hu,
Fusheng Zhou,
Y u Wang,
Jiong Lan,
Qiang Lu
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Products
Name of Patent
Family (1) Jurisdiction Status
Patent
Application Grant Date
Patent
Expiration (2) Type
Owner/
Applicant Inventor (3)
Pharmaceutical
Composition, and
Preparation Method
Therefor and Use
Thereof
China, United
States
Pending 2023-9-20 – – Invention GenFleet Y uanyuan Xie,
Lina Qi, Can
Huang, Jiong
Lan, Qiang Lu
Method for
Preparation of
Pyrazine-
Naphthyridine
Diketones and
Intermediates
Thereof
PCT Pending 2024-8-15 – – Invention GenFleet Jinzhu Zhao,
Y udong Cao,
Lun Xiong,
Xiong Wei,
Xiangchao
Liu, Mengting
Meng,
Fusheng Zhou,
JingRong Li,
Jiong Lan,
Qiang Lu
GFH375 /H1118/H1118Pyrimidine-Fused
Ring Compound,
and Preparation
Method Therefor
and Use Thereof
China,
United States
Pending 2023-9-25 – – Invention GenFleet,
GenFleet
Zhejiang
Tao Jiang,
Fusheng Zhou,
Tao Liang,
Chonglan Lin,
Lijian Cai,
Zhubo Liu,
Xiaoming Xu,
Kai Ma,
Leitao Zhang,
Zhen Li, Jiong
Lan
GFH312 /H1118/H1118Dihydronaphthyridinone
Compound, and
Preparation Method
Therefor and
Medical Use
Thereof
China Granted 2021-2-9 2024-2-9 2041-2-9 Invention GenFleet,
GenFleet
Zhejiang
Fusheng Zhou,
Xiaoming Xu,
Leitao Zhang,
Xin Li, Lili
Tang, Jiong
Lan
United States Pending – –
Crystal Form of
RIPK1 Inhibitor,
Acid Salt Thereof,
and Crystal Form of
Acid Salt Thereof
China,
United States
Pending 2022-8-2 – – Invention GenFleet,
GenFleet
Zhejiang
Fusheng Zhou,
Y uanzhi Tao,
Jinzhu Zhao,
Jiong Lan
GFH276 /H1118/H1118Macrocyclic
Compounds, and
Preparation Method
Therefor and Use
Thereof
PCT Pending 2024-8-30 – – Invention GenFleet Jichen Zhao,
Fusheng Zhou,
Tao Liang,
Y andong Lu;
Tao Jiang;
Chonglan Lin;
Ling Peng;
Jiong Lan;
Qiang Lu
GFH009
(4) /H1118Inhibitor of Cyclin-
Dependent Kinase
CDK9
China,
United States
Granted China:
2017-4-19;
United States:
2018-1-3
China:
2020-6-19;
United States:
2021-3-23
China:
2037-4-19;
United States:
2038-1-3
Invention GenFleet,
GenFleet
Zhejiang
Gang Zhou
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Products
Name of Patent
Family (1) Jurisdiction Status
Patent
Application Grant Date
Patent
Expiration (2) Type
Owner/
Applicant Inventor (3)
GFH018 (4) /H1118Benzotriazole-Derived
/H9251And
/H9252-Unsaturated
Amide Compound
Used as TGF- /H9252R1
Inhibitor
China,
United States
Granted 2017-6-8 China:
2021-2-26;
United States:
2020-2-4
2037-6-8 Invention GenFleet,
GenFleet
Zhejiang
Fei Sun, Lifang
Wu, Charles
Z. Ding,
Guoping Hu,
Jian Li,
Shuhui Chen,
Jianyu Lu
Abbreviations: PCT = Patent Cooperation Treaty; EPO = European Patent Office
Notes:
(1) Unless otherwise indicated, the name of patents and patent applications within the same family is the same and
is therefore disclosed once.
(2) The patent expiration date is estimated based on current filing status, without taking into account any possible
patent term adjustments or extensions and assuming payment of all appropriate maintenance, renewal, annuity
and other government fees.
(3) All the inventors of the patents and patent applications listed in this table were employees of the Group when
the related inventions were conceived, except for the patents relating to GFH009 and GFH018, because these
patents were transferred from third parties. We have no dispute with these inventors regarding the ownership
and disposition rights of the patents and patent applications listed in this table.
(4) The U.S. patents in connection with GFH009 and GFH018, as listed in the table, are owned by GenFleet only.
The term of an individual patent may vary based on the countries/regions in which it is
granted. The actual protection afforded by a patent varies on a claim-by-claim and
country-by-country basis and depends upon many factors, including the type of patent, the
scope of its coverage, the availability of any patent term extension or adjustment, the
availability of legal remedies in a particular country/region and the validity and enforceability
of the patent. We cannot provide any assurance that patents will be issued with respect to any
of our pending patent applications or any such patent applications that may be filed in the
future, nor can we provide any assurance that any of our owned, or in-licensed issued patents
or any such patents that may be issued in the future will be commercially useful in protecting
our product candidates and the methods of manufacturing the same. Nevertheless, as of the
Latest Practicable Date, we have not encountered any challenge to the validity to our issued
patents from a third party; nor have we identified any prior art or other circumstances that may
lead to invalidation of our issued patents. Our IP counsel as to the PRC and U.S. intellectual
property law and EU IP Counsel as to the laws of EPC contracting countries, after independent
search and review of the legal status of the material patents listed in the above table, are not
aware of any claim, action, suit or proceeding pertaining to the validity, enforceability or scope
of those issued patents, nor aware of any fact or legal impediment with respect to those pending
patent applications that would preclude the issuance of patents.
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Our IP counsels have conducted patent search in the freedom-to-operate analysis for our
Core Products GFH925 and GFH375. The coverage of the patent search was limited to the PCT
applications, as well as the patents and patent applications in the key target markets where our
Core Products are expected to be marketed, namely: China, the U.S. and the European Union
for GFH925; China and the U.S. for GFH312; China and the U.S. for GFH375. Accordingly,
our freedom-to-operate analysis did not include Taiwan, Hong Kong and Macau. As of the
Latest Practicable Date, save as disclosed below, we are not aware of any unexpired patent that
may cover these product candidates in their respective key markets.
We have identified that certain issued patents in China and U.S. belonging to third parties
appear to cover the chemical structure of or formed by GFH925 and may not expire before our
anticipated commercial launch of GFH925 in China and the U.S. To proactively manage any
potential risks from these patents, we have been monitoring the status of such patents and their
related patent applications; to the extent that we consider as necessary, we have entered into
license agreements with certain third party holders of such patents, to ensure our activities
relating to GFH925 in target markets will not be hindered by these patents. Specifically, the
third-party patents in China may cover the chemical structure of GFH925. This is due to the
first-to-file system and publication delays, where those third parties first filed patent
applications that were published after a waiting period, during which we filed our own patent
applications related to GFH925. As such, we did not have any knowledge of those third parties’
patent applications until their publication, and those third parties acknowledged that we
independently developed our own patent rights covering the chemical structure of GFH925
with potentially overlapping claims. We have entered into license agreements with those
third-party patent holders to proactively prevent any potential infringement risks. We are
required to make a total of RMB34.5 million to the third party patent holders and mid-teens
royalties tied to the achievement of specific regulatory, commercialization milestones and
receipt of royalty payments to one of the patent holders. Such mid-teens royalties is contingent
on our receipt of regulatory, commercial milestone payments and royalty payments from
sublicensees (Innovent is currently the only sublicensee). As of the Latest Practicable Date, we
have paid such RMB34.5 million pursuant to the license agreement. We do not expect the
“mid-teens royalties” will have any material adverse impact on our business operation and
financial conditions, as such royalties is contingent on our receipt of payments from regulatory,
commercial milestone and royalty payments from sublicensees (Innovent is currently the only
sublicensee), and constitutes only a relatively small part of the regulatory, commercial
milestone and royalty payments to be received by us. As a result of such licensing agreements,
we have pre-empted potential issues over GFH925 in China with those third-party patent
holders, whose patents in China would not affect our freedom to operate GFH925 and its future
commercialization in China, as advised by our IP counsel as to the PRC intellectual property
laws. The same third-party patent holders have patent applications of the same patent family
still pending and under review by the USPTO and the EPO, and there remains uncertainty as
to whether the patent applications in the U.S. or the EU can be issued with a scope that covers
GFH925. Our IP counsel has advised that these pending patent applications do not present a
material impact on the FTO analysis of GFH925. In particular, the pending claims of the
currently pending U.S. patent application had been amended, to address novelty and
enablement issues after a previous rejection by the USPTO, in a form that no longer covers the
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chemical structure of GFH925. For details of relevant license agreements, please see “Risk
Factors — Risks Relating to Our Intellectual Property Rights — If we or our collaborators are
unable to obtain and maintain adequate patent and other intellectual property protection for our
pipeline products throughout the selected markets in the world, our ability to successfully
commercialize our pipeline products may be adversely affected.”
We are also aware of a U.S. patent whose claim scope is excessively broad and appears
to cover the chemical structure formed by GFH925 bonded to certain residue of KRAS protein,
which is a desired functional characteristic of GFH925. To further assess the potential risk, we
have conducted a comprehensive freedom-to-operate analysis with respect to our core
products, including GFH925, in the U.S. and sought advice from our legal advisor as to the
U.S. intellectual property laws. Based on this analysis, and considering the legal standards in
the U.S. regarding claim validity, including enablement and written description requirements,
we believe that these broadly defined claims, which are solely based on functional
characteristics without specifying their chemical structures, may raise concerns about their
validity and enforceability in U.S. courts due to insufficient enablement and written description
support. Our legal advisor as to the U.S. intellectual property laws has further advised that the
likelihood of these broadly defined claims having a significant impact on the freedom to
operate of GFH925 in the U.S. is low, and therefore the risk of this U.S. patent hindering our
future commercialization efforts in the U.S. is remote. For details of the U.S. patent, please see
“Risk Factors — Risks Relating to Our Intellectual Property Rights — We may become subject
to intellectual property infringement claims, which could expose us to substantial liability,
harm our reputation, limit our research and development or other business activities and/or
impair our ability to commercialize our product candidates.” As such, as of the Latest
Practicable Date, we have not attempted to approach the holder of the U.S. patent regarding
GFH925; nor has the holder approached us or taken any action regarding GFH925 that we are
aware of. As of the Latest Practicable Date, neither we nor our IP counsels are aware of any
patent infringement proceedings related to GFH925 in China, the U.S., or the EPC contracting
countries.
As a result of foregoing, as reviewed and advised by our IP counsels, as of the Latest
Practicable Date, we believe that we have sufficient patent protection for our Core Products in
their respective key target markets, and we are not aware of any facts that cause us to believe
that the development and commercialization of our Core Products would infringe any issued
patents of any third party that, in our IP counsels’ opinion, are valid and enforceable in their
respective key target markets. Except for the above-mentioned issues related to certain China
and U.S. patents, there are no other issues noted from the freedom to operate analysis that may
affect our rights to conduct research and development, commercialisation, and submission of
patent claims for GFH925 in China, U.S. and E.U. and for GFH375 in China and U.S.
We may rely, in some circumstances, on trade secret and/or confidential information to
protect aspects of our product candidates. We seek to protect our proprietary product
candidates and processes, in part, by entering into confidentiality agreements with consultants,
scientific advisors and contractors, and invention assignment agreements with our employees.
We have entered into confidentiality agreements with our senior management and key members
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of our R&D team and other employees who have access to trade secrets or confidential
information about our business. Our standard employment contract, which we used to employ
each of our employees, contains an assignment clause, under which we own all the rights to
all inventions, technology, know-how and trade secrets derived during the course of such
employee’s work.
These agreements may not provide sufficient protection of our trade secret and/or
confidential information. These agreements may also be breached, resulting in the
misappropriation of our trade secret and/or confidential information, and we may not have an
adequate remedy for any such breach. In addition, our trade secret and/or confidential
information may become known or be independently developed by a third party, or misused by
any collaborator to whom we disclose such information. Despite any measures taken to protect
our intellectual property, unauthorized parties may attempt to or successfully copy aspects of
our products or to obtain or use information that we regard as proprietary without our consent.
As a result, we may be unable to sufficiently protect our trade secrets and proprietary
information.
We also seek to preserve the integrity and confidentiality of our data and trade secrets by
maintaining physical security of our premises and physical and electronic security of our
information technology systems. Despite any measures taken to protect our data and
intellectual property, unauthorized parties may attempt to or successfully gain access to and use
information that we regard as proprietary. Please see “Risk Factors — Risks Relating to Our
Intellectual Property Rights” in this Prospectus for a description of risks related to our
intellectual property.
We conduct our business under the brand name of “GenFleet” and/or “˙.” As of the
Latest Practicable Date, we held five registered trademarks in Mainland China and three
registered trademarks in Hong Kong. We are also the owner of eight registered software
copyrights and one domain name.
During the Track Record Period and up to the Latest Practicable Date, (i) we were not
involved in any legal, arbitral or administrative proceedings in respect of, and we had not
received notice of any material claims of infringement, misappropriation or other violations of,
third-party intellectual property; and (ii) we were not involved in any proceedings in respect
of any intellectual property rights that may be threatened or pending and that may have an
influence on the research and development for any of our product candidates in which we may
be a claimant or a respondent.
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OUR CUSTOMERS
In 2023 and 2024 and first four months of 2025, our revenue was generated from three
customers relating to multiple performance obligations including (1) grants of licenses to
intellectual property rights and (2) the research and development services. We generally grant
a credit term of 30 days to 60 days from the first day of the following month after receipt of
value-added tax invoice to our customers. Neither of them is our supplier.
Customer Background
Product/
Service Sold
Credit
Terms
Commencement
of Business
Relationship
(Since)
Sale
Amount
% of Total
Revenue
for the
Period
(RMB in
thousand)
For the year ended December 31, 2023
Customer B /H1118Founded in 2011, a
biopharmaceutical
company that
focuses on fields of
oncology,
cardiovascular and
metabolic diseases,
autoimmune
diseases and
ophthalmology;
place of
incorporation:
Cayman Islands
grants of licenses to
intellectual
property rights
30 to 45
business
days
2021 71,779 97.3%
Customer A /H1118Founded in 2012, a
late-stage clinical
biopharmaceutical
company that
focuses on
development of
cancer treatments;
place of
incorporation: U.S.
grants of licenses to
intellectual
property rights
and R&D services
30 to 60
days
2022 1,955 2.7%
Total /H1118/H1118/H1118/H1118/H1118 73,734 100.0%
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Customer Background
Produce/
Service Sold
Credit
Terms
Commencement
of Business
Relationship
(Since)
Sales
Amount
% of Total
Revenue
of the
Period
(RMB in
thousand)
For the year ended December 31, 2024
Customer B /H1118Founded in 2011, a
biopharmaceutical
company that
focuses on fields of
oncology,
cardiovascular and
metabolic diseases,
autoimmune
diseases and
ophthalmology;
place of
incorporation:
Cayman Islands
grants of licenses to
intellectual
property rights
and sales of goods
30 to 45
business
days
2021 104,703 100.0%
Total /H1118/H1118/H1118/H1118/H1118 104,703 100.0%
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Customer Background
Product/
Service Sold
Credit
Terms
Commencement
of Business
Relationship
(Since)
Sale
Amount
% of Total
Revenue
for the
Period
(RMB in
thousand)
For the four months ended April 30, 2025
Customer B /H1118Founded in 2011, a
biopharmaceutical
company that
focuses on fields of
oncology,
cardiovascular and
metabolic diseases,
autoimmune
diseases and
ophthalmology;
place of
incorporation:
Cayman Islands
grants of licenses to
intellectual
property rights
30 to 45
business
days
2021 4,310 5.2%
Customer C /H1118Founded in 2010, a
biopharmaceutical
company that
focuses on
development of
cancer treatments;
place of
incorporation: U.S.
grants of licenses to
intellectual
property rights
and R&D services
30 to 60
days
2023 77,618 94.5%
Total /H1118/H1118/H1118/H1118/H1118 81,928 99.7%
To the best of our knowledge, the three customers during the Track Record Period are
Independent Third Parties. None of our Directors, their respective associates or any
shareholder who, to the knowledge of our Directors, owned more than 5% of our issued share
capital as of the Latest Practicable Date, has any interest in any of the three customers during
the Track Record Period.
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OUR SUPPLIERS
During the Track Record Period, our major suppliers primarily consisted of CROs and
CDMOs and we did not experience any material disputes with our suppliers. In addition, we
believe that adequate alternative sources for such supplies exist, and we have developed
alternative sourcing strategies for these supplies. We will establish necessary relationships with
alternative sources based on supply continuity risk assessment. We generally have credit
periods of 30 days.
Below is a summary of the key terms of a typical agreement with our CROs and CDMOs.
 Services. The CRO or CDMO provides us with services such as implementing a
clinical research project, manufacturing products and/or providing materials as
specified in the master agreement and completing ad-hoc work orders.
 Term. The CRO or CDMO is required to perform its services according to the
prescribed time frame set out in the master agreement or a work order.
 Payment. We are required to make payments to the CRO or CDMO according to the
payment schedule agreed by the parties.
 Confidentiality. We and the CRO or CDMO agree to keep confidential any
information in relation to the performance of the master agreement.
 Credit terms. We usually arrange payment within one to three months of receipt of
invoice from CRO or CDMOs. Installment payments will be made in accordance
with the milestone payment arrangements specified in the agreement.
 Intellectual property. We own all intellectual property derived from the clinical
research project, and we are entitled to apply patent for such intellectual properties.
 Medical liabilities . The CDMO will be liable for medical events and accidents that
occur as a result of non-compliance with the quality of drugs manufactured by the
CDMO.
 Liabilities and termination . The liability of a CRO or CDMO arises at the failure to
provide services in accordance with the agreed upon service schedule, and our
liability arises at the failure to make timely arrangements for payment in accordance
with credit terms. If either party is prevented from or delayed in the performance of
its obligations under the agreement by force majeure for more than 60 consecutive
or aggregate days or if either party is in breach of the agreement and fails to remedy
its breach for more than 30 days after notice is given by the non-breaching party, the
non-breaching party shall have the right to terminate the agreement immediately by
written notice to such breaching party.
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In 2023, 2024 and the four months ended April 30, 2024 and 2025, our purchases from
our five largest suppliers in each year/period in aggregate amounted to RMB94.1 million,
RMB108.5 million, RMB26.9 million and RMB34.0 million, representing 44.4%, 44.3%,
47.5% and 41.7% of our total corresponding purchases in such period, respectively, and our
purchases from the largest R&D supplier in each period accounted for 11.3%, 12.7%, 17.1%
and 11.6% of our total corresponding purchases, respectively. Our material increase in the
expenses attributable to the five largest suppliers for each year/period during the Track Record
Period is in line with the advancement of clinical trials of our product candidates.
The following table sets forth details of our five largest suppliers for each year/period
during the Track Record Period.
Supplier Background Major Purchases
Credit
Terms
Commencement
of Business
Relationship
(Since)
Purchase
Amount
% of Total
Purchases
for the
Period
(RMB in
thousand)
For the year ended December 31, 2023
Supplier F /H1118/H1118Founded in 2006, a
CDMO service
provider that
specializes in the
design and
manufacturing of
drug molecules;
place of
incorporation:
Jiangsu Province
CDMO services 30 working
days
2021 23,943.9 11.3%
Supplier B /H1118/H1118Founded in 2005,
offers CRDMO end-
to-end solutions in
drug development
and manufacturing;
place of
incorporation:
Chongqing
CDMO services 30 days 2020 23,368.0 11.0%
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Supplier Background Major Purchases
Credit
Terms
Commencement
of Business
Relationship
(Since)
Purchase
Amount
% of Total
Purchases
for the
Period
(RMB in
thousand)
Supplier G /H1118/H1118Founded in 1982,
utilizes data,
technology, and
advanced analysis to
provide clinical
research service;
place of
incorporation: U.S.
CRO services 30 days 2022 23,372.1 11.0%
Supplier H /H1118/H1118Founded in 2015,
offers CRDMO end-
to-end solutions in
drug development
and manufacturing;
place of
incorporation:
Shanghai
CDMO services 30 working
days
2020 12,998.6 6.1%
Supplier I /H1118/H1118/H1118Founded in 2004,
offers integrated
biopharmaceutical
R&D service
platform, providing
R&D solutions
across the drug
development cycle;
place of
incorporation:
Zhejiang Province
CRO services 45 days 2018 10,406.9 4.9%
Total /H1118/H1118/H1118/H1118/H1118 94,089.5 44.4%
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Suppliers Background Major Purchases
Credit
Terms
Commencement
of Business
Relationship
(Since)
Purchase
Amount
% of Total
Purchases
of the
Period
(RMB in
thousand)
For the year ended December 31, 2024
Supplier F /H1118/H1118Founded in 2006, a
CDMO service
provider that
specializes in the
design and
manufacturing of
drug molecules;
place of
incorporation:
Jiangsu Province
CDMO services 30 working
days
2021 31,063.5 12.7%
Supplier B /H1118/H1118Founded in 2005,
offers CRDMO end-
to-end solutions in
drug development
and manufacturing;
place of
incorporation:
Chongqing
CDMO services 30 days 2020 27,349.8 11.2%
Supplier G /H1118/H1118Founded in 1982,
utilizes data,
technology, and
advanced analysis to
provide clinical
research service;
place of
incorporation: U.S.
CRO services 30 days 2022 21,880.0 8.9%
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Suppliers Background Major Purchases
Credit
Terms
Commencement
of Business
Relationship
(Since)
Purchase
Amount
% of Total
Purchases
of the
Period
(RMB in
thousand)
Supplier J /H1118/H1118Founded in 2011, a
trading and
import/export
company
specializing in
chemical products,
medical devices, and
technical services;
place of
incorporation:
Hengdian, Zhejiang
Province
CDMO services 45 days 2022 14,508.7 5.9%
Supplier K /H1118/H1118Founded in 2015, a
CDMO service
provider that
specializes in
antibody,
recombinant protein,
and ADC drug
development and
manufacturing;
place of
incorporation:
Hangzhou, Zhejiang
Province
CDMO services 45 days 2020 13,733.8 5.6%
Total /H1118/H1118/H1118/H1118/H1118 108,535.7 44.3%
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Suppliers Background Major Purchases
Credit
Terms
Commencement
of Business
Relationship
(Since)
Purchase
Amount
% of Total
Purchases
of the
Period
(RMB in
thousand)
For the four months ended April 30, 2025
Supplier G /H1118/H1118Founded in 1982,
utilizes data,
technology, and
advanced analysis to
provide clinical
research service;
place of
incorporation: U.S.
CRO services 30 days 2022 9,439.8 11.6%
Supplier H /H1118/H1118Founded in 2015,
offers CRDMO end-
to-end solutions in
drug development
and manufacturing;
place of
incorporation:
Shanghai
CDMO services 30 working
days
2020 8,891.4 10.9%
Supplier F /H1118/H1118Founded in 2006, a
CDMO service
provider that
specializes in the
design and
manufacturing of
drug molecules;
place of
incorporation:
Jiangsu Province
CDMO services 30 working
days
2021 7,233.3 8.9%
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Suppliers Background Major Purchases
Credit
Terms
Commencement
of Business
Relationship
(Since)
Purchase
Amount
% of Total
Purchases
of the
Period
(RMB in
thousand)
Supplier K /H1118/H1118Founded in 2015, a
CDMO service
provider that
specializes in
antibody,
recombinant protein,
and ADC drug
development and
manufacturing;
place of
incorporation:
Hangzhou, Zhejiang
Province
CDMO services 45 days 2020 5,012.6 6.1%
Supplier L /H1118/H1118Founded in 2006, a
CDMO service
provider that
specializes in small
molecules, biologics
and new modalities
such as ADCs/
XDCs, peptides and
PROTACs drug
development and
manufacturing;
place of
incorporation:
Shanghai
CDMO services 45 days 2018 3,455.0 4.2%
Total /H1118/H1118/H1118/H1118/H1118 34,032.1 41.7%
All of our five largest suppliers in each year/period during the Track Record Period are
Independent Third Parties. None of our Directors or any Shareholder who, to the knowledge
of our Directors, owns more than 5% of our issued share capital immediately following
completion of the Global Offering, nor any of their respective associates had any interest in any
of our five largest suppliers in each year/period during the Track Record Period.
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The following table sets forth details of the five largest CROs we engaged for each
year/period during the Track Record Period.
CRO Background
Commencement
of Business
Relationship
(Since)
Purchase
Amount
Drug Candidate
for which the
CRO provided
service
(RMB in
thousand)
For the year ended December 31, 2023
CRO A (i.e., Supplier G) /H1118Founded in 1982, utilizes data,
technology, and advanced
analysis to provide clinical
research service; place of
incorporation: U.S.
2022 23,372.1 GFH925
CRO B (i.e., Supplier I) /H1118/H1118Founded in 2004, offers
integrated biopharmaceutical
R&D service platform,
providing R&D solutions
across the drug development
cycle; place of incorporation:
Zhejiang Province
2018 10,406.9 GFH018,
GFH925,
GFH009
CRO C /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Founded in 2019, focuses on
providing full-service clinical
research and development of
drugs and devices; place of
incorporation: Shanghai
2022 7,950.3 GFH018,
GFH009,
GFH312
CRO D /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Founded in 1997, provides
clinical development services
across all phases of clinical
trials and therapeutic areas;
place of incorporation:
Australia
2021 7,451.9 GFH018
CRO E /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Founded in 2014, one of the
world’s largest CROs that
provides full range of Phase I
to IV clinical development
services; place of
incorporation: Ireland
2020 3,560.3 GFH009
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CRO Background
Commencement
of Business
Relationship
(Since)
Purchase
Amount
Drug Candidate
for which the
CRO provided
service
(RMB in
thousand)
For the year ended December 31, 2024
CRO A (i.e., Supplier G) /H1118Founded in 1982, utilizes data,
technology, and advanced
analysis to provide clinical
research service; place of
incorporation: U.S.
2022 21,880.0 GFH925
CRO B (i.e., Supplier I) /H1118/H1118Founded in 2004, offers
integrated biopharmaceutical
R&D service platform,
providing R&D solutions
across the drug development
cycle; place of incorporation:
Zhejiang Province
2018 6,804.7 GFH018,
GFH925,
GFH009,
GFH375,
GFS202A
CRO C /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Founded in 2019, focuses on
providing full-service clinical
research and development of
drugs and devices
2022 4,910.0 GFH018,
GFH009,
GFH375
CRO D /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Founded in 1997, provides
clinical development services
across all phases of clinical
trials and therapeutic areas;
place of incorporation:
Australia
2021 4,625.2 GFH018
CRO E /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Founded in 2014, one of the
world’s largest CROs that
provides full range of Phase I
to IV clinical development
services; place of
incorporation: Ireland
2020 4,325.0 GFH009
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CRO Background
Commencement
of Business
Relationship
(Since)
Purchase
Amount
Drug Candidate
for which the
CRO provided
service
(RMB in
thousand)
For the four months ended April 30, 2025
CRO A (i.e., Supplier G) /H1118Founded in 1982, utilizes data,
technology, and advanced
analysis to provide clinical
research service; place of
incorporation: U.S.
2022 9,439.8 GFH925
CRO F /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Founded in 2010, offers
screening and discovery
services, non-clinical
pharmacodynamics, non-
clinical pharmacokinetics,
non-clinical safety evaluation,
clinical sample bioanalysis,
biomarkers and translational
research; place of
incorporation: Shanghai
2018 1,609.3 GFH276,
GFS784,
GFH375,
GFS202A
CRO C /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Founded in 2019, focuses on
providing full-service clinical
research and development of
drugs and devices
2022 851.1 GFH018,
GFH375
CRO B (i.e., Supplier I) /H1118/H1118Founded in 2004, offers
integrated biopharmaceutical
R&D service platform,
providing R&D solutions
across the drug development
cycle; place of incorporation:
Zhejiang Province
2018 748.9 GFH009,
GFH375,
GFH925,
GFS202A
CRO D /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Founded in 1997, provides
clinical development services
across all phases of clinical
trials and therapeutic areas;
place of incorporation:
Australia
2021 236.8 GFH018
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The following table sets forth details of the five largest CDMOs we engaged for each
year/period during the Track Record Period.
CDMO Background
Commencement
of Business
Relationship
(Since)
Purchase
Amount
Drug Candidate
for which the
CRO provided
service
(RMB in
thousand)
For the year ended December 31, 2023
CDMO A (i.e.,
Supplier F) /H1118/H1118
Founded in 2006, a CDMO service
provider that specializes in the
design and manufacturing of drug
molecules; place of incorporation:
Jiangsu Province
2021 23,943.9 GFH375,
GFH925,
GFH312
CDMO B (i.e.,
Supplier H) /H1118/H1118
Founded in 2015, it provides services
in medicinal chemistry SAR
development, synthetic route
scouting, process optimization, and
production to multi-ton scale; place
of incorporation: Shanghai
2020 12,998.6 GFH925
CDMO C /H1118/H1118/H1118/H1118/H1118Founded in 2004, offers comprehensive
research, development, and
manufacturing service capabilities
throughout the drug discovery,
preclinical, clinical development,
and commercialization process for
small molecules, biologics, and CGT
products; place of incorporation:
Beijing
2019 7,806.3 GFH018,
GFH375,
GFH925,
GFH009
CDMO D /H1118/H1118/H1118/H1118/H1118Founded in 2007, provides one-stop
service for new drug R&D as well
as commercial production and
dedicates to the drug discovery,
pharmaceutical processes R&D, and
the commercial manufacturing of
APIs and intermediates; place of
incorporation: Shanghai
2023 3,669.8 GFH375
CDMO E (i.e.,
Supplier B) /H1118/H1118
Founded in 2005, offers CRDMO end-
to-end solutions in drug development
and manufacturing; place of
incorporation: Chongqing
2020 3,259.7 GFH925,
GFH009
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CDMO Background
Commencement
of Business
Relationship
(Since)
Purchase
Amount
Drug Candidate
for which the
CRO provided
service
(RMB in
thousand)
For the year ended December 31, 2024
CDMO A (i.e.,
Supplier F) /H1118/H1118
Founded in 2006, a CDMO service
provider that specializes in the
design and manufacturing of drug
molecules; place of incorporation:
Jiangsu Province
2021 31,063.5 GFH375,
GFH276,
GFS784, GFH925
CDMO E (i.e.,
Supplier B) /H1118/H1118
Founded in 2005, offers CRDMO end-
to-end solutions in drug development
and manufacturing; place of
incorporation: Chongqing
2020 27,349.8 GFH925
CDMO F (i.e.,
Supplier J) /H1118/H1118/H1118
Founded in 2011, a trading and
import/export company specializing
in chemical products, medical
devices, and technical services;
place of incorporation: Hengdian,
Zhejiang Province
2022 14,508.7 GFH925
CDMO G (i.e.,
Supplier K) /H1118/H1118
Founded in 2015, provides stable cell
line development services, one-stop
R&D and production solution for
antibodies, fusion proteins, and ADC
products from protein engineering,
early druggability evaluation, CMC
process development to commercial
production; place of incorporation:
Zhejiang Province
2020 13,733.8 GFS202A
CDMO H /H1118/H1118/H1118/H1118/H1118Founded in 2009, it provides
CRO/CDMO services of the APIs
and pharmaceutical intermediates
from lab scale R&D, to process
development, to pilot production and
commercial production; place of
incorporation: Jiangsu Province
2020 1,319.3 GFH925
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CDMO Background
Commencement
of Business
Relationship
(Since)
Purchase
Amount
Drug Candidate
for which the
CRO provided
service
(RMB in
thousand)
For the four months ended April 30, 2025
CDMO I (i.e.,
Supplier H) /H1118/H1118
Founded in 2015, offers CRDMO
end-to-end solutions in drug
development and manufacturing;
place of incorporation: Shanghai
2020 8,891.4 GFH925
CDMO A (i.e.,
Supplier F) /H1118/H1118
Founded in 2006, a CDMO service
provider that specializes in the
design and manufacturing of drug
molecules; place of incorporation:
Jiangsu Province
2021 7,233.3 GFH375,
GFH276,
GFH312
CDMO G (i.e.,
Supplier K) /H1118/H1118
Founded in 2015, a CDMO service
provider that specializes in antibody,
recombinant protein, and ADC drug
development and manufacturing;
place of incorporation: Hangzhou,
Zhejiang Province
2020 5,012.6 GFS202A,
GFS784
GFS101A
CDMO J (i.e.,
Supplier L) /H1118/H1118
Founded in 2006, a CDMO service
provider that specializes in small
molecules, biologics and new
modalities such as ADCs/XDCs,
peptides and PROTACs drug
development and manufacturing;
place of incorporation: Shanghai
2018 3,455.0 GFH276,
GFH375,
GFH925,
GFH312
CDMO H /H1118/H1118/H1118/H1118/H1118Founded in 2009, it provides
CRO/CDMO services of the APIs
and pharmaceutical intermediates
from lab scale R&D, to process
development, to pilot production and
commercial production; place of
incorporation: Jiangsu Province
2020 2,896.9 GFH925
We plan to continue engaging these major CROs/CDMOs. In 2023, we engaged 5 CROs
and 15 CDMOs, for which we incurred expenses of RMB52.7 million and RMB86.1 million,
respectively. In 2024, we engaged 5 CROs and 10 CDMOs, for which we incurred expenses of
RMB42.5 million and RMB89.4 million, respectively. In the first four months of 2025, we
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engaged 5 CROs and 10 CDMOs, for which we incurred expenses of RMB12.9 million and
RMB29.2 million, respectively. The decrease in the expenses incurred for engaging CROs and
the number of engaged CDMOs were primarily due to the changed needs of many of our R&D
projects.
COMPETITION
The pharmaceutical and biotechnology industries are characterized by rapidly advancing
technologies, competition and a strong emphasis on proprietary drugs. While we believe our
pipeline of clinical and preclinical stage proprietary assets, leading R&D capability,
technology platforms and seasoned management team provide us with competitive advantages,
we face potential competition from many different sources, including major pharmaceutical,
specialty pharmaceutical and biotechnology companies, academic institutions, and public and
private research institutions. Any product candidates that we successfully develop and
commercialize will compete with existing drugs and new drugs that may become available in
the future.
We focus on leveraging our industry experience and established R&D capabilities for the
in-house discovery and development of differentiated therapeutics in the fields of oncology,
autoimmune and inflammatory diseases. We face fierce competition from existing products and
product candidates under development in the market. See “Industry Overview” for more details
on the competitive landscape of the various markets in which we compete. We face
uncertainties in clinical trial development which are subject to a variety of factors, including
satisfactory safety and efficacy results from clinical trials, successful enrollment of patients,
and performance of CROs and other parties involved in clinical trial development and others.
INSURANCE
We maintain insurance policies that we consider to be in line with market practice and
adequate for our business. Our principal insurance policies cover adverse events in clinical
trials. We maintain social insurance for our employees in accordance with relevant PRC laws
and regulations. We also purchase property insurances against property loss. We currently do
not maintain insurance for environmental liability. Please refer to “Risk Factors — Risks
Relating to Our Operations — We have limited insurance coverage, and any claims beyond our
insurance coverage may result in our incurring substantial costs and a diversion of resources.”
in this Prospectus.
We consider that the coverage from the insurance policies maintained by us is adequate
for our present operations and is in line with the industry norm. During the Track Record
Period, we had not made or been the subject of any material insurance claims.
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EMPLOYEES
As of the Latest Practicable Date, we had 90 employees in total (excluding two
co-founders). The following table sets forth the number of our employees categorized by
function as of the Latest Practicable Date.
Functions
Number of
employees by
function Percentage
Research and Development /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111868 76%
Business Strategy and Corporate Development /H1118/H1118/H1118 33 %
General and Administrative /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819 21%
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111890 100.0%
We expect to make ordinary-course adjustments to our human capital, including our
research and development team from time to time for various reasons, including strategic
initiatives to enhance operational efficiency and voluntary departures of our staff. The number
of R&D staff responsible for clinical development of our Core Products has generally remained
stable during the Track Record Period, and we do not currently anticipate any material changes
to our key R&D personnel that would have a significant impact on our operations or the
research and development of our Core Products.
We enter into individual employment contracts with our employees covering salaries,
bonuses, employee benefits, workplace safety, confidentiality and non-competition, work
product assignment clause and grounds for termination.
To maintain our workforce’s quality, knowledge, and skill levels, we provide continuing
education and training programs, including internal training, to improve their technical,
professional or management skills. We also provide training programs to our employees from
time to time to ensure their awareness and compliance with our policies and procedures in
various aspects. Furthermore, we provide various incentives and benefits to our employees,
including competitive salaries, bonuses and share-based payment, particularly our key
employees.
Our employees’ remuneration comprises salaries, bonuses, provident funds, social
security contributions, and other welfare payments. We have made contributions to our
employees’ social security insurance funds (including pension plans, medical insurance,
work-related injury insurance, unemployment insurance and maternity insurance) and housing
funds pursuant to applicable laws and regulations. We have complied with all statutory social
security insurance fund and housing fund obligations applicable to us under the laws and
regulations in China in all material aspects during the Track Record Period and as of the Latest
Practicable Date, except that we did not make full social security insurance contributions for
certain employees who are not PRC citizens, which we estimate to be approximately RMB1.1
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million during the Track Record Period. We currently plan to make such full contributions in
2026. As of the Latest Practicable Date, (i) the employees had confirmed such arrangement and
had raised no objections in relation thereto; (ii) there had been no disputes between us, such
employees and/or the third-party human resources agency with regard to such arrangement, as
the case may be; and (iii) we had not received any notice of rectification from, or been imposed
any administrative penalty by, the relevant governmental authorities as a result of such
arrangement or nonpayment for employees who are not PRC citizens. As advised by our PRC
Legal Advisor, taking into consideration the above, the risk of us being subject to material
penalties as a result of not paying social insurance premium for employees who are not PRC
citizens, or paying the social insurance premium and housing provident funds for the relevant
employee through the third-party agency, which thus have a material adverse effect on our
financial condition or results of operations taken as a whole, is relatively low. Please refer to
the section headed “Risk Factors — Risks Relating to Doing Business in Jurisdictions Where
We Operate — We are subject to risks in relation to our social insurance and housing provident
fund contributions.” in this Prospectus.
Workplace Safety
We have adopted and maintained a series of rules, standard operating procedures, and
measures to maintain our employees’ healthy and safe environment. We implement safety
guidelines to set out information about potential safety hazards and procedures. We require
employees to participate in safety training to familiarize themselves with the relevant safety
rules and procedures. Also, we have policies in place and have adopted relevant measures to
ensure the hygiene of our work environment and the health of our employees.
Our PRC Legal Advisor has confirmed that, during the Track Record Period and up to the
Latest Practicable Date, we had not been subject to any material penalty in relation to health,
work safety, social and environmental protection.
PROPERTIES
As of the Latest Practicable Date, we did not own any real property. We leased several
properties in Mainland China with an aggregate GFA of approximately 4,159.4 sq.m. We did
not lease any properties overseas. We believe our current facilities are sufficient to meet our
near-term needs, and additional space can be obtained on commercially reasonable terms to
meet our future needs.
BUSINESS
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The following table sets forth the details of our material leased properties as of the Latest
Practicable Date:
Usage Location GFA (sq.m) Expiry Date
Office, R&D and
General Business
Operations /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Shanghai, China 3,063.4 October 31, 2028
R&D /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Shaoxing, China 1,000.0 September 13, 2026
We also leased certain properties with an aggregate GFA of approximately 96 sq.m for
satellite office in Shanghai and employee dormitory purpose in Shaoxing.
We plan to comply with the lease agreement registration requirement regarding our lease
agreements. However, as the filing of the lease agreements requires the coordination of both
lessors and lessees, the lessors may not cooperate and complete the registration in a timely
manner.
As of the Latest Practicable Date, none of our lease agreements for properties in China
had been registered with relevant authorities in China. Our PRC Legal Advisor is of the view
that the non-registration of lease agreements will not affect the validity of the lease
agreements, but the relevant local housing administrative authorities can require us to complete
registrations within a specified timeframe and if we fail to so rectify, we may be subject to a
fine of between RMB1,000 and RMB10,000 for each of these leasing properties. For further
details, please see the sections headed “Risk Factors — Risks Relating to Doing Business in
Jurisdictions Where We Operate — We are subject to risks associated with our leased
properties.”
As of the Latest Practicable Date, no single property interest that formed part of
non-property activities had a carrying amount of 15%, and no single property interest that
formed part of property activities had a carrying amount of 1%, of our total assets. Therefore,
according to Chapter 5 of the Listing Rules and section 6(2) of the Companies (Exemption of
Companies and Prospectuses from Compliance with Provisions) Notice (Cap. 32L of the Laws
of Hong Kong), this Prospectus is exempted from compliance with the requirements of section
342(1)(b) of the Companies (Winding Up and Miscellaneous Provisions) Ordinance in relation
to paragraph 34(2) of the Third Schedule to the Companies (Winding Up and Miscellaneous
Provisions) Ordinance, which requires a valuation report with respect to our Group’s interests
in land or buildings.
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PERMITS, LICENSES AND OTHER APPROV ALS
As of the Latest Practicable Date, we had obtained all requisite licenses, approvals and
permits from relevant authorities that are material to our operations in the PRC and the United
States and such licenses, permits and certifications all remain in full effect. For more details
regarding the laws and regulations to which we are subject, see “Regulations” in this
Prospectus. We had not experienced any material difficulty in renewing such licenses, permits,
approvals and certificates during the Track Record Period and up to the Latest Practicable Date,
and we currently do not expect to have any material difficulty in renewing them when they
expire, if applicable. There is no material legal impediment in renewing such licenses, permits,
approvals and certificates as they expire in the future as long as we are in compliance with
applicable laws, regulations and rules. During the Track Record Period and up to the Latest
Practicable Date, we had not been penalized by any government authorities for any
non-compliance relating to maintenance and renewal of our material licenses, permits,
approvals and certificates.
The following table sets forth the details of our material licenses, permits and approvals
as of the Latest Practicable Date:
License/Permit Issuing Authority Holder Grant Date Expiration Date
High-tech Enterprise
Certificate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Science and
Technology
Commission of
Shanghai
Municipality,
Shanghai
Municipal Finance
Bureau, Shanghai
Municipal Tax
Service, State
Taxation
Administration
Our Company December 14,
2022
December 13,
2025 (in the
process of
renewal)
Quality Management
System Certification
(ISO9001) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
TUVHD Certification
Testing Co., Ltd
Our Company May 18, 2024 May 17, 2027
Shanghai Pathogenic
Microorganism
Laboratory
Certificate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Pudong Health
Commission of
Shanghai
Municipal
Our Company December 31,
2019
N/A
Consignee and
Consignor of Import
and Export Goods /H1118/H1118/H1118
Pudong Customs Our Company January 20, 2022 July 31, 2068
BUSINESS
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A W ARDS AND RECOGNITION
We have leveraged our independent R&D capabilities and innovative strategy to achieve
over dozens of certifications and accolades since our establishment. Many awards received
since 2024, exclusively open to companies with commercialized products, highlight our growth
in scale, pipeline strength, and commercialization success.
In 2022, we obtained national “High-Tech Enterprise” certification (ॴ৷อҦஔΆุ
֛on our first application and advanced in 2024 to be recognized as a “National Specialized
and New ‘Little Giant’ Enterprise (ॴਖ਼ၚतอ“ʃ̶ɛ”Άุ၈໮).” Within three years
since our inception, we were also named a “Shanghai Multinational Corporation R&D Center
(೯ʕː),” reflecting our focus on globally innovative products and
international vision.
Over the past two years, we have been featured on the Hurun Global Gazelle Enterprise
Ranking, recognized for our rapid valuation growth from a “Cheetah Enterprise” to a “Gazelle
Enterprise.” This year, with the launch of our first commercial product through collaborations
with our partner, we were included in Fortune magazine’s IMPACT “China’s Most Socially
Influential Startups” list.
The table below sets forth an indicative list of some of the awards and recognitions we
have received as of the Latest Practicable Date.
Awards Y ear Grant Authority
Shanghai Science and
Technology “Little Giant”
Cultivation Enterprise ( ɪऎ̹
Ҧʃ̶ɛ੃ԃΆุ) /H1118/H1118/H1118/H1118/H1118/H1118/H1118
2024 Science and Technology
Commission of Shanghai
Municipality, Shanghai
Municipal Finance Bureau and
Shanghai Municipal
Commission of Economy and
Informatization
Hurun Future Unicorns – Global
Gazelles Index 2024 (2024ߡ
ᆗΌଢᐙୣΆุ࿮) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
2024 Hurun Report
National Specialized and New
“Little Giant” Enterprise
(ॴਖ਼ၚतอ“ʃ̶ɛ”Άุ
၈໮)/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
2024 Ministry of Industry and
Information Technology
(MIIT)
National Biopharmaceutical
Enterprise Platform Governing
Unit (ᔼᖹΆุ̨̻
ଣԫఊЗ) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
2024 National Biopharmaceutical
Enterprise Platform
BUSINESS
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Awards Y ear Grant Authority
Key Service Unicorn (Potential)
Enterprise in Shanghai ( ɪऎ
ਕዹԉᖕ(ᆑɢ)Άุ)
2024 Shanghai MCEI SME Service
Center
Shanghai Municipal Enterprise
Technology Center Title ( ɪऎ
̹ΆุҦஔʕː၈໮) /H1118/H1118/H1118/H1118/H1118/H1118/H1118
2024 Shanghai Commission of
Economy and Informatization/
Shanghai Tax Bureau/Shanghai
Finance Bureau/Shanghai
Customs
Fortune China’s Most Socially
Impactful Startups Top 60 /H1118/H1118/H1118/H1118
2024 Fortune Magazine
Forbes China’s Top 100 Most
Influential Chinese Elites /H1118/H1118/H1118/H1118
2024 Forbes
Shanghai Specialized and New
SME /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
2023 Shanghai Municipal Commission
of Economy and
Informatization (“ Shanghai
MCEI SME Service Center ”)
2023 Hurun Global Gazelle
Enterprise /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
2023 Hurun Report
National High-Tech Enterprise
Certification (ॴ৷อҦஔ
֛)H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
2022 Shanghai Science and
Technology
Commission/Shanghai
Municipal Finance
Bureau/National Tax Bureau,
Shanghai
Biopharmaceutical Innovation
Golden Seed Award (ᔼᖹ
ᆤ) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
2022 China Pharmaceutical Industry
Information Center
2022 Hurun Global Gazelle
Enterprise /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
2022 Hurun Report
2021 VENTURE50 Investment
Community Leaderboard /H1118/H1118/H1118/H1118/H1118
2021 PEDaily.cn
Shanghai Multinational
Corporation R&D Center
(೯ʕː) /H1118/H1118/H1118/H1118/H1118
2019 Shanghai Municipal Commission
of Commerce
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ENVIRONMENTAL, SOCIAL AND GOVERNANCE
Corporate Governance
ESG Governance Framework
The Board fully recognizes the importance of Environmental, Social, and Governance
(ESG) management in achieving the Company’s green, compliance, and sustainability
realization. Therefore, throughout the Company’s management and operation processes, the
Board actively promotes the implementation of ESG principles and integrates them into the
Company’s governance framework. The Board has authorized the CEO to establish an ESG
Management Committee, which is responsible for monitoring and researching laws,
regulations, and policies in the company’s ESG domain, identifying, and managing ESG-
related risks and opportunities that have a significant impact on the Company’s business,
assessing the Company’s overall ESG performance, and providing corresponding
recommendations. The ESG Management Committee shall consist of one Chairperson, who
will be the CEO, and the CEO may appoint another senior executive as the Executive
Chairperson of the ESG Management Committee. The remaining members shall be composed
of department heads, directors, and other members deemed necessary for inclusion. The
Chairperson and Executive Chairperson are responsible for unified leadership, approving
various ESG tasks, and overseeing related information disclosures. The other members are
responsible for implementing the ESG Management Committee’s directives and overseeing the
management and implementation of ESG issues. Under the ESG Committee, an ESG Working
Group is established to promote the implementation and execution of ESG issues, monitor the
implementation status of ESG issues, and regularly collect, organize, and report the progress,
performance, and case studies related to ESG issues managed by each responsible department.
Each issue is assigned a responsible person composed of personnel from several functional
departments.
The Board and all the employees have already acquired relevant ESG knowledge and are
actively applying ESG principles in practice. Looking ahead, we will also consider engaging
external experts to provide professional ESG training for the Board and all the employees. This
measure is intended to ensure that our Board could continuously update and maintain current
ESG knowledge, thereby enabling informed and effective ESG-related decision-making. Upon
the listing, we will further refine and enhance our ESG governance framework as necessary.
Materiality ESG Issues
The Company actively implements the environmental, social, and governance
requirements in all aspects, with its basic ESG obligations fulfilled as a publicly listed
company. We have maintained good relationships with stakeholders of the Company, including
government and regulatory authorities, shareholders and investors, customers, business
partners, employees, and the public, adhering to principles of mutual benefit and consistently
upholding our social responsibilities.
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Drawing on the MSCI ESG Industry Materiality Map, with reference to the healthcare
industry materiality list in the Hong Kong Stock Exchange’s Environmental, Social, and
Governance Reporting Guide, the SASB Healthcare Materiality Map, and the key material ESG
issues identified by industry leading ESG-rated enterprises — together with the Company’s
actual situation, we have preliminarily identified the following material ESG issues:
Materiality Issue Materiality Quantitative Metrics
Business Ethics &
Anti-Corruption /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Highly material Average training hours completed per
employee for anti-corruption
(hours/person)
Number of corruption lawsuits filed
and/or adjudicated (case)
R&D and Innovation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Highly material R&D expenses as a percentage of
operating revenue (%)
Intellectual Property Protection /H1118/H1118Moderately material Number of intellectual properties held
(item)
Development & Training /H1118/H1118/H1118/H1118/H1118/H1118Highly material Employee training coverage rate (%)
Occupational Health and Safety /H1118Highly material Lost Days Due to Work Injury (Days)
Risk Management /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Highly material Number of significant risk incidents
(case)
Data Privacy & Security /H1118/H1118/H1118/H1118/H1118/H1118/H1118Highly material Total number of incidents violating
regulations and voluntary guidelines
related to customer privacy (case)
Climate Change /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Moderately material Total greenhouse gas (GHG) emissions
(tons)
Economic losses due to climate change
(RMB0’000)
Product Quality & Safety /H1118/H1118/H1118/H1118/H1118/H1118Moderately material Percentage of the total number of
products sold or shipped that have to
be recalled for safety and health
reasons (%)
Resource Usage /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Moderately material Water usage (tons)
Electricity consumption (MWh)
Waste Management /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Moderately material Hazardous waste emissions (tons)
Supply Chain Management /H1118/H1118/H1118/H1118/H1118Moderately material Number of suppliers (companies)
Equal Employment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Moderately material Female employee ratio (%)
Customer Relations /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Moderately material Customer complaint resolution rate (%)
Community Contribution /H1118/H1118/H1118/H1118/H1118/H1118Generally material Amount invested in social public
welfare (RMB0’000)
Upon the listing, the ESG working team will further refine its diversified communication
mechanisms together with proactive connections with stakeholders to gain an understanding of
their views and suggestions on sustainable performance and future development strategies. The
feedback collected from the continuing review on materiality issues would be integrated and
reported to the Board so that it could timely assess the materiality of various issues to
stakeholders and enterprise which conduces to the formulation of the materiality matrix more
applicable to the Company.
BUSINESS
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Business Ethics
We place great importance on anti-corruption and strictly complies with relevant laws and
regulations, including the Company Law of the People’ s Republic of China , the Anti-Unfair
Competition Law of the People’ s Republic of China , and the Opinions on Certain Issues
Concerning the Application of Law in Handling Criminal Cases of Commercial Bribery . The
Company maintains a zero-tolerance policy towards corruption, bribery, extortion, fraud, and
money laundering. All the employees are required to comply with local laws and regulations
as well as the Company’s internal policies, and must not leverage their positions or
work-related advantages to seek improper benefits or damage the Company’s interests. In
addition, the Company actively fosters clean and transparent cooperation with stakeholders,
further standardizes its procurement processes, and advances integrity in procurement
practices.
Employee Rights Protection
Training and Development
One of our corporate values is “Collaborative Coexistence”: boosting efficiency with
synergy, growing across boundaries. By collaborating across functions and roles, we aim to
achieve business growth and ensure every employee’s development. The Company provides
internal and external training to ensure employees enhance and refine their skill sets related to
their work. To encourage skill enhancement and broaden career paths, each employee would be
offered with open, fair, and impartial self-development opportunities and platforms based on
his/her qualified performance and potential. The clear rank and promotion channels would be
available for current employees while key ones shall attain targeted trainings.
Health and Safety
The health and safety of employees is a top priority for the Company. We strictly comply
with relevant laws and regulations, including the Production Safety Law of the People’ s
Republic of China (2021 edition) , the Occupational Disease Prevention Law of the People’ s
Republic of China , the Regulations on the Safety Management of Hazardous Chemicals , and
the Work Injury Insurance Regulations . We have established and continuously improves safety
management and occupational health systems, formulating a range of policies including the
Safety Production Responsibility System, the Occupational Health (including Work Injury)
Management System, the Safety Management System for Hazardous Chemicals (including
Controlled Substances), and the Management Measures of Personal Protective Equipment.
Considering the functional characteristics of each department, the Company clearly defines
departmental responsibilities in safety management, as well as employees’ job duties and
health objectives in their operational activities. These measures ensure the safety and health of
employees throughout the production process. The safety management department is
responsible for the organization of the relevant departments, whose trainings for employees
include aspects of production safety and compliance with rules and regulations, three-level
education for new employees, and pre-job training and certification for employees with special
work types. Through these initiatives, the Company actively fulfills its primary responsibility
for occupational health and safety.
BUSINESS
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Green Operations and Response to Climate Change
We incorporate the principles of green chemistry into the research, testing, and production
processes for every product. The Company is committed to ensuring the safety of
pharmaceutical raw materials, prioritizing atom economy in reaction design, and focusing on
environmentally friendly outcomes. We continuously refine our processes and promote
cutting-edge technologies such as enzyme catalysis and crystallization engineering. These
efforts reduce the use of hazardous substances and the generation of waste, thereby fulfilling
our commitment to environmental safety and public health. Our strict enforcement of the
biological and chemical experiment system standards in the pharmaceutical industry, brings
protection for the environment and employees’ health, along with our green chemical design
practices and experimental waste emission guidelines. In collaboration with multiple
enterprises, we adopt a high-tech-driven, eco-friendly model to develop the “one center and
three strengths” innovation hub in Zhangjiang Headquarters Park. We will continue to develop
and optimize our energy management system, establish internal environmental risk assessment
protocols, and implement wastewater and exhaust gas treatment systems. In doing so, we fulfill
our social responsibility to conserve energy and reduce emissions.
Resource Use
We comply with the Energy Conservation Law of the People’s Republic of China ( ʕ
) and the Circular Economy Promotion Law of the People’s
Republic of China (), along with other relevant laws and
regulations. We have issued the “Civilized Office Initiative,” aiming to reduce resource usage
through various measures:
 Resource Conservation: When employees need to use vehicles for business travel,
they must strictly follow the Company’s procedures for application and approval,
effectively saving gasoline and reducing company costs. We advocate for paperless
office practices, with black and white double-sided default printing settings, and
require print previews to ensure accuracy before printing.
 Energy Conservation: We manage air conditioning usage rationally to avoid resource
waste caused by unnecessary usage. We implement detailed management of
electrical equipment, ensuring that devices are not left on standby for extended
periods.
 Water Conservation: We post water-saving signs and encourage employees to
develop the habit of turning off water taps when not in use, fostering water
conservation awareness.
BUSINESS
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Our primary resource consumption involves gasoline, electricity, and water. The summary
of the total consumption and intensity for 2023 and 2024 are summarized as follows:
Water consumption
2023 2024
Tons /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,752 1,255
(Tons per person) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814.24 11.21
Gasoline consumption
2023 2024
L /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11187,082 7,332
Intensity (L per person) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111857.58 65.46
Electricity consumption
2023 2024
MWh /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118970.41 791.99
Intensity (MWh per person) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11187.89 7.07
Pollutant Emissions
We strictly comply with the national and local laws and regulations, including the
Atmosphere Pollution Prevention and Control Law of the People’ s Republic of China , the Water
Pollution Prevention and Control Law of the People’ s Republic of China , and the Law of the
People’ s Republic of China on the Prevention and Control of Environmental Pollution by Solid
Wastes. We have established an environmental protection management system that covers
emissions of exhaust gases, water, and hazardous waste. We also provide training to relevant
personnel to reinforce our environmental management practices. Apart from regular checks on
facilities, the Company employs qualified institutions to routinely monitor wastewater and
exhaust gas emissions to ensure they have met emission standards when the management and
disposal of solid waste have been systematized in daily operations.
Since we are currently still focused on drug research and development, the volume of
hazardous waste we generated is limited. This primarily includes experimental waste liquids,
experimental waste mother solution, experimental waste residue, experimental waste drugs,
used laboratory vessels, waste activated carbon and waste HEPA filter element. We have set up
a temporary storage area for storing hazardous waste as a qualified third-party company would
remove and dispose of it on a regular basis. General waste, primarily consisting of domestic
refuse, is collected and handed over to property or sanitation department for centralized
transportation. All solid waste treatment and disposal measures strictly adhere to
environmental protection requirements.
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We adopt a strategy of purchasing in smaller quantities more frequently to avoid the
accumulation of expired or unusable hazardous chemicals due to excessive inventory, thus
reducing hazardous waste generation. We also prioritize using reagents with higher safety
profiles to reduce the risk of generating hazardous waste. For the years ended December 31,
2023 and 2024, the amount of hazardous and non-hazardous waste generated by us is as
follows:
2023 2024
Hazardous Waste (tons) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815.55 14.62
In order to effectively mitigate the environmental impact of exhaust gas emissions, we
have implemented different treatment measures for various types of emissions. Solid dosage
dust is collected by fume hoods and enclosed equipment systems. Laboratory waste gases
generated from volatile organic reagents and disinfectants are centrally collected through
dedicated ventilation ducts, treated by accompanying activated carbon adsorption devices, and
then discharged through exhaust pipes high on the rooftop of the buildings they locate.
Biological aerosols are treated by HEPA filters inside biological safety cabinets prior to
releasement into the laboratory. We also reduce exhaust emissions by increasing the frequency
of replacing activated carbon materials in our adsorption devices. For the years ended
December 31, 2023 and 2024, the total amount of pollutants emitted from our laboratory’s
exhaust is as follows:
2023 2024
V olatile Organic Compounds
(VOCs) (tons) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180.37 0.43
Our wastewater mainly consists of liquid waste generated from pharmaceutical R&D
activities and domestic wastewater. The wastewater generated from R&D is strictly controlled
in compliance with applicable laws and regulations by the Company. Our experimental
wastewater primarily comes from the cleaning of chemical laboratory equipment and vessels,
pure water preparation, ice-making, and evaporative condensate drainage. Among the above,
the rinsing method is used in the first two stages of wastewater from chemical experimental
cleaning, where wastewater contains higher concentrations of reagents to be disposed as
hazardous waste by a third-party contractor. The subsequently collected cleaning wastewater,
pure water preparation wastewater, and ice-making wastewater are directed to the municipal
sewage pipe network together with domestic wastewater. Furthermore, we implement several
measures to minimize wastewater generation, including collection of water from dehumidifiers
for flushing toilets, and setting up a centralized dishwashing area to reduce water usage and
wastewater discharge, thus lowering the overall volume of sewage produced. For the years
ended December 31, 2023 and 2024, the details of our wastewater emission are as follows:
2023 2024
Chemical Oxygen Demand (kg) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118106.47 72.35
Ammoniacal Nitrogen (kg) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185.89 0.68
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Greenhouse Gas Emissions
For the years ended December 31, 2023 and 2024, our carbon dioxide emissions are as
follows:
2023 2024
Scope 1 (tons of CO 2 equivalent) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111818.84 19.5
Scope 2 (tons of CO 2 equivalent) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118533.42 451.67
Total Greenhouse Gas Emissions
(tons of CO 2 equivalent) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118572.26 471.17
Intensity (tons of CO 2 equivalent per person) /H1118/H1118/H1118/H1118 4.65 4.21
Goals and Strategies
The majority of our carbon emissions come from Scope 2 emissions associated with
purchased electricity. Accordingly, a series of environmental management plans have been
developed to continually improve our resource consumption efficiency with guarantee for
observance of all our operations with relevant government environmental regulations and
requirements to avoid or reduce the negative environmental impacts. We have been constantly
reducing electricity usage in daily office operations utilizing approaches including green
lighting controls, energy-saving settings for office equipment and air conditioning, and
conference room usage management.
To lessen Scope 1 carbon emissions, tightened management and minimized usage of
official vehicles have been carried out. The electric vehicles are considered as priority choices
when there are needs for replacing official vehicles or purchasing new vehicles.
We have also attached significance to Scope 3 carbon emissions. We plan to initiate an
assessment of our Category 3 greenhouse gas emissions and have implemented a series of
reduction measures targeting these emissions. We aim to complete data collection for Scope 3
in 2024 by early 2025, which will serve as our baseline for future data comparisons.
To reduce Scope 3 emissions, we have developed, among others, the following measures:
(i) Posting water and electricity conservation signs in prominent office locations to raise
employees’ environmental awareness; (ii) Encouraging double-sided printing and the use of
electronic reports to promote a paperless office environment; (iii) Encouraging
teleconferencing or online meetings to reduce unnecessary business travel for face-to-face
meetings; (iv) Urging employees to prioritize public transportation for commuting and business
travel to achieve greener mobility; (v) Maximizing recycling, repurposing, and
remanufacturing in our production processes to improve solid waste utilization rates and
reduce waste generation; (vi) Evaluating suppliers’ environmental performance in areas such
as energy use, production processes, and transportation methods, and encouraging them to
optimize their carbon emissions.
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We will continue to closely monitor suppliers and upstream/downstream transportation to
lower carbon emissions in these segments. Using 2023 as our baseline year, we are committed
to achieving a 10% reduction in water intensity in mainland China and ensuring 100%
compliant disposal of hazardous waste by 2030. We will also regularly review our progress
towards these goals and adjust and refine our strategies in line with the Company’s ongoing
development.
The Board is responsible for the evaluation and management of ESG-related risks,
opportunities, and goals. Our overall resource consumption and emissions are expected to
increase with business expansion. We are committed to improving the environmental
performance across our entire value chain, including office operations, supplier selection, raw
material inflows, experimental processes, and waste management, to control the intensity of
resource consumption and waste levels. Based on our historical energy consumption and
average industry level, we have formulated the following specific ESG-related goals:
2024 (Actual)
Goals for the
Next Three Y ears
(2025-2027)
Greenhouse Gas Emissions (Scop e1+2 ) (tons of
CO2 equivalent per person) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184.21 no more than 5
Electricity Consumption Intensity (MWh per
person) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11187.07 no more than 8
The Board will regularly review the Group’s performance against ESG goals. If
significant deviations are identified, appropriate adjustments will be made to the ESG-related
measures. Our directors believe that these measures will not affect the Company’s operations,
either financially or non-financially.
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Response to Climate Change
Following the unceasing expansion in scope of global climate change, it is becoming an
increasingly prominent international issue. The impact of frequent extreme weather events and
natural disasters has rapidly changed public perceptions, drawing widespread attention. With
a sustained focus on the effects of climate change on the pharmaceutical industry and our
business operations, the Company, with reference to TCFD recommendations, assesses and
implements a variety of climate change risk management measures. These efforts aim to ensure
our long-term resilience to climate risks and maintain vigilance in responding to the potential
climate-related impacts and risks.
We will monitor climate-related risks and opportunities at least once a year during Board
meetings to safeguard the smooth progress on climate-related issues in compliance. The ESG
Committee is responsible for formulating and reviewing climate-related strategies,
coordinating climate-related efforts, and communicating the latest issues affecting the
Company to the Board. To keep the Board updated on climate-related risks and opportunities,
we provide climate-related trainings every two years, inviting external experts to share their
insights.
Given the current nature of our business, climate change is not expected to pose a
significant impact on our operations. However, in the future, we may face acute and chronic
physical risks such as extreme weather events (e.g. typhoons and floods) and increases in
average temperatures, which could damage our property and assets, including buildings, and
cause business disruptions due to delays in timely delivery by production/supply chains. By
implementing property insurance, emergency preparedness plans, and strengthening supply
chain management, we aim to address these risks.
Certain climate-related transition risks may also get close to us, including rising costs of
energy and raw materials as well as the disposal of pollutants or hazardous waste under
increasingly stringent environmental regulations, the costs associated with low-emission
technology transformation (e.g. R&D in green chemistry technologies), and shifts in
downstream customer preferences (e.g. order losses and revenue declines due to failure of
disclosure on carbon neutrality goals and data to meet downstream customers’ demand). To
address these risks, we will enhance compliance operations and information disclosure,
improve communication with stakeholders, strengthen the introduction and training of
professional talent, and reinforce supply chain management. In addition, we will actively
advance green chemistry R&D, intensify energy conservation and consumption reduction
efforts, and improve energy efficiency.
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LEGAL PROCEEDINGS AND NON-COMPLIANCE
Legal Proceedings
During the Track Record Period and up to the Latest Practicable Date, we were not a party
to any actual or threatened legal or administrative proceedings. We are committed to
maintaining the standards of compliance with the laws and regulations applicable to our
business. However, we may from time to time be subject to various legal or administrative
claims and proceedings arising in the ordinary course of business.
Legal Compliance
According to our PRC Legal Advisor, during the Track Record Period and up to the Latest
Practicable Date, we had not been and were not involved in any material non-compliance
incidents that led to fines, enforcement actions or other penalties that could, individually or in
the aggregate, have a material adverse effect on our business, financial condition or results of
operation. Our Directors confirmed that we had complied with all material applicable laws and
regulations for our operations in the PRC and the United States and we were not involved in
any material or systemic non-compliance incidents in the PRC and the United States.
RISK MANAGEMENT AND INTERNAL CONTROL
Risk Management
We are exposed to various risks in our business operations, and we believe that risk
management is important to our success. For more details, see “Risk Factors — Risks Relating
to Our Operations” in this Prospectus. Our Directors oversee and manage the overall risks
associated with our operations. We have prepared written terms of reference in compliance
with Rule 3.21 of the Listing Rules and the Corporate Governance Code and Corporate
Governance Report as set out in Appendix C1 to the Listing Rules.
To monitor the ongoing implementation of our risk management policies and corporate
governance measures after the Listing, we have adopted or will continue to adopt, among other
things, the following risk management measures:
 establish an Audit Committee to review and supervise our financial reporting
process and internal control system;
 adopt various policies to ensure compliance with the Listing Rules, including but not
limited to aspects related to risk management, connected transactions and
information disclosure;
 provide anti-corruption and anti-bribery compliance training periodically to our
senior management and employees to enhance their knowledge and compliance with
applicable laws and regulations; and
 attend training sessions by our Directors and senior management in respect of the
relevant requirements of the Listing Rules and duties of directors of companies
listed in Hong Kong.
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Internal Control
We have employed an independent internal control consultant to assess our internal
control system in connection with the Listing. The internal control consultant has conducted a
review procedure on our internal control system in certain aspects, including financial
reporting and disclosure controls, corporate level controls, information system control
management and other procedures for our operations. We had improved our internal control
system by adopting and implementing the corresponding enhanced internal control measures.
Going forward, we will continue to regularly review and improve these internal control
policies, measures and procedures.
We have also appointed external legal counsel to advise us on compliance matters, such
as compliance with the regulatory requirements on clinical R&D. Under our whistle blowing
policy, we make our internal reporting channel open and available for our employees to report,
on an anonymous basis, any non-compliance incidents and acts, including bribery and
corruption. Reported incidents and persons will be investigated and appropriate measures will
be taken in response to the findings. We have also established anti-bribery guidelines and
compliance requirements. After considering the remedial actions we have taken, our Directors
are of the view that our internal control system is adequate and effective for our current
operations.
We plan to provide our Directors, senior management, and relevant employees with
continuous training programs and updates regarding the relevant laws and regulations regularly
to proactively identify any concerns and issues relating to any potential non-compliance.
Anti-bribery
We maintain a strict code of conduct and anti-corruption policies among our employees
and third parties. We believe we will be less affected by the increasingly stringent measures
taken by the PRC government to correct corruptive practices in the pharmaceutical industry.
We strictly prohibit bribery or other improper payments in our business operations. This
prohibition applies to all business activities, anywhere globally, whether involving government
officials or healthcare professionals. Improper payments prohibited by this policy include
bribes, kickbacks, excessive gifts or entertainment, or any other payment made or offered to
obtain an undue business advantage. We keep accurate books and records that reflect
transactions and asset dispositions in reasonable detail. Requests for false invoices or payment
of unusual, excessive or inadequately described expenses should be rejected and promptly
reported. Misleading, incomplete or false entries in our books and records are never acceptable.
We will also ensure that future commercialization team personnel comply with applicable
promotion and advertising requirements, including restrictions on promoting drugs for
unapproved uses or patient populations and limitations on industry-sponsored scientific and
educational activities.
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We have adopted comprehensive internal control measures for anti-corruption and
anti-bribery by (i) providing regular anti-corruption and anti-bribery compliance training for
senior management and employees, including daily compliance team meeting, annual
compliance training and other ad hoc compliance training sessions, to enhance their knowledge
and compliance with applicable law and regulations; (ii) monitoring books, records and
accounts with respect to supplier management, tendering and bidding process management and
financial payment management to identify any false, misleading or undisclosed entries; (iii)
establishing whistle-blowing mechanisms and encouraging all employees, suppliers, customers
and other third parties to report suspicious activities and violations of the policies.
Conflict of Interest and Non-Competition
Our code of conduct clearly defines the scope of conflicts of interest, including supplier
and customer relationships, hospitality and gifts, financial interests and personnel matters. Our
employees, including but not limited to our Directors and R&D team members, may not have
or be suspected of having a personal interest in business dealings with our suppliers, customers,
competitors or distributors; accept monetary, financial or other benefits from our suppliers,
customers, competitors or distributors; have close relatives who work for our suppliers,
customers, competitors or distributors; serve as a consultant or director in an association or
company in the same market or industry. At the same time, employees shall keep confidential
information strictly confidential and agree on the definition of confidential information, the
content covered, the use of intellectual properties, including but not limited to any transfer of
know-how, acquisition of technologies, and potential breach liabilities.
All of the Company’s executives have signed a non-compete agreement upon joining the
Company, which prohibits them from engaging in any way in a business that competes with the
Company’s business, and, unless agreed to in writing by the Company, working for any third
party full-time or part-time. Any of our employees shall not, without prior written approval
from our Company, own, manage, operate or control any other entity that competes with our
Company.
Data Privacy Protection
We have established procedures to protect the confidentiality of patients’ data. We
implement strict internal policies to govern the collection, handling, storage, retrieval of, and
access to our patients’ personal data and medical records and protect the security and
confidentiality of personal information to ensure compliance with all applicable national or
international rules and regulations on data protection and privacy. We usually require our
personnel to collect and safeguard personal information in their possession. Our information
technology network is configured with multiple layers of protection to secure our databases
and servers. We have also implemented a variety of protocols and procedures to safeguard our
data assets and prevent unauthorized access to our network. According to the GCP and relevant
regulations, access to clinical trial data has been strictly limited to authorized personnel. In
order to strengthen the management of our database, ensure the normal and effective operation
of the database, and ensure the security of the database, we have designated database
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administrator to carry out the responsibilities of daily maintenance, authority control, security
protection and other management of the database. Additionally, we require external parties and
internal employees involved in clinical trials to comply with confidentiality requirements. Data
are to be used only for the intended use, as agreed by the patients and consistent with the
informed consent form.
Furthermore, we enter into confidentiality agreements with our employees who have
access to any aforementioned privacy information. The confidentiality agreements provide
that, among other things, these employees are legally obligated not to misuse the confidential
information while in office, to surrender all confidential information in possession while
resigning, and to retain their confidential obligations after they leave office. We also implement
a series of measures to ensure our employees’ compliance with our data security measures. For
instance, we provide training to our employees on relevant data security policies.
We attach importance to data protection, data transfer and data security, and have taken
relevant measures as follows:
1. We have established a clinical trial data security management system to standardize
our internal data security management;
2. We hold routine staff training to enhance the compliance and safety awareness of all
staff to ensure compliance and safety of data processing;
3. We have continuously upgraded our information security technology and established
firewalls to improve data security;
4. We entered into agreements with CROs and other collaboration partners contain data
protection clauses setting out their responsibilities for data protection.
During the Track Record Period and up to the Latest Practicable Date, we did not
experience any breach of confidential client information or any other client information-related
incidents which could cause a material adverse effect on our business, financial condition or
results of operations. Our PRC Legal Advisor have confirmed that, during the Track Record
Period and up to the Latest Practicable Date, we had not been subject to any material penalty
in relation to data privacy, and had been in compliance with the relevant PRC laws and
regulations in all material aspects in this regard. During the Track Record Period, as advised
by our PRC Legal Advisor, we had not been subject to administrative penalties relating to data
transfer, and we have been in compliance with relevant PRC laws and regulations in all
material aspects in this regard.
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BOARD OF DIRECTORS
Our Board comprises eight Directors, including three executive Directors, two non-
executive Directors and three independent non-executive Directors. Pursuant to the Articles of
Association, our Directors are elected and appointed by our Shareholders at a Shareholders’
meeting for a term of three years, which is renewable upon re-election and re-appointment.
The following table sets out information regarding the Directors.
Name Age Position/Title
Date of
Appointment
as a Director
Date of Joining
Our Group
Roles and
Responsibilities
Executive Directors
Dr. Qiang LU /H1118/H1118/H111859 Executive Director
and Chairman of
the Board
November 2,
2017
August 2017 Overall strategic
planning, financial
management, and
business management
of our Group
Dr. Jiong LAN /H1118/H111853 Executive Director,
Chief Executive
Officer and General
Manager
November 30,
2017
August 2017 Overall supervision and
management of the
business operation of
our Group
Ms. ZHANG Wei
(ੵᙯ) /H1118/H1118/H1118/H1118/H1118/H1118
46 Executive Director,
secretary to the
Board and joint
company secretary
November 25,
2024
August 2017 Supervision of
financing and
investment related
matters of our Group
Non-executive Directors
Mr. ZHU
Jingyang
(ϡᘩජ) /H1118/H1118/H1118/H1118
36 Non-executive Director August 1, 2022 August 2022 Providing strategic
advice and making
recommendation on
the operation and
management of our
Group
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Name Age Position/Title
Date of
Appointment
as a Director
Date of Joining
Our Group
Roles and
Responsibilities
Ms. TAO Sha
(ௗ୶) /H1118/H1118/H1118/H1118/H1118/H1118
31 Non-executive Director November 25,
2024
November 2024 Providing strategic
advice and making
recommendation on
the operation and
management of our
Group
Independent non-executive Directors
Ms. Christine
Shaohua LU-
WONG
(ጅჭശ) /H1118/H1118/H1118/H1118
56 Independent
Non-executive
Director
December 3,
2024
(Note)
December 2024 Advising our Group on
issues relating to
corporate
governance, audit
and providing
independent opinion
to the Board
Dr. ZHOU Demin
(մᅃઽ) /H1118/H1118/H1118/H1118
59 Independent
Non-executive
Director
December 3,
2024
(Note)
December 2024 Advising our Group on
issues relating to
corporate
governance, audit
and providing
independent opinion
to the Board
M r .L IB o
(ت)H1118/H1118/H1118/H1118/H1118/H1118
54 Independent
Non-executive
Director
December 3,
2024
(Note)
December 2024 Advising our Group on
issues relating to
corporate
governance, audit
and providing
independent opinion
to the Board
Note: The appointment will become effective upon the Listing.
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Executive Directors
Dr. Qiang LU , aged 59, is our executive Director and Chairman of the Board. Dr. Lu is
the co-founder of our Group and is responsible for overall strategic planning, financial
management, and business management of our Group. Dr. Lu was appointed as a Director on
November 2, 2017. Dr. Lu is also in charge of the Company’s finance related functions with
the support of the Company’s finance department, which comprises mangers and officers with
relevant qualification and ample experience in finance and accounting related area since
incorporation. Dr. Lu himself has been formally designated as “பɛ (Head of Finance)”
of the Company under the PRC rules and regulations since June 2024.
Dr. Lu has over 20 years of experience in the biotechnology and pharmaceutical industry.
Before founding the Group, Dr. Lu served as a senior vice president of CStone Pharmaceuticals
(Suzhou) Co., Ltd. ( ਿͩᖹุ(ᘽψ)ʮ̡) until August 2017, which later became a
wholly-owned subsidiary of CStone Pharmaceuticals ( ਿͩᖹุ), a pharmaceutical company
listed on the Hong Kong Stock Exchange (stock code: 2616). Before he joined CStone
Pharmaceuticals (Suzhou) Co., Ltd., he successively served as chief scientific officer and a
vice president of Harbin Gloria Pharmaceuticals Co., Ltd. (ʮ̡), a
pharmaceutical company listed on the Shenzhen Stock Exchange (stock code: 002437) from
February 2015 to May 2016; and chief scientific officer of Y angtze River Pharmaceutical
Group Co., Ltd. (ʮ̡), a pharmaceutical company, from June 2013 to
February 2015. From April 2008 to June 2013, he served as a vice president at WuXi AppTec
(Shanghai) Co., Ltd. (ʮ̡), a wholly-owned subsidiary of WuXi
AppTec Co., Ltd. (ʮ̡), a pharmaceutical company listed on
the Shanghai Stock Exchange (stock code: 603259) and the Hong Kong Stock Exchange (stock
code: 2359). Before he joined WuXi AppTec (Shanghai) Co., Ltd., he served as head of ion
channel and cellular toxicology in Novartis Institutes for BioMedical Research, Inc., a
pharmaceutical research organization of Novartis AG, a medicines company, until April 2008.
From April 2000 to February 2006, he worked at Wyeth, a pharmaceutical company.
Dr. Lu received his bachelor’s degree in biochemistry from Peking University ( ̏ԯɽኪ)
in China in July 1987 and Doctor of Philosophy degree in biochemistry from Brandeis
University in the United States in May 1996. After receiving his Doctor of Philosophy degree,
he continued his research at the Departments of Physiology and Neuroscience at Tufts
University School of Medicine in the United States.
Dr. Jiong LAN , aged 53, is our executive Director, Chief Executive Officer and General
Manager. Dr. Lan is the co-founder of our Group and is responsible for overall supervision and
management of the business operation of our Group. Dr. Lan was appointed as a Director on
November 30, 2017.
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Dr. Lan has over 20 years of experience in the biotechnology and pharmaceutical industry.
Before founding the Group, he served as general manager of Shanghai Haiyan Pharmaceutical
Technology Co., Ltd. (ʮ̡), a wholly-owned subsidiary of Y angtze
River Pharmaceutical Group Co., Ltd. (ʮ̡), a pharmaceutical company,
from August 2013 to August 2017. From October 2011 to July 2013, he served as head of the
department of medicinal chemistry at Shanghai Hengrui Pharmaceuticals Co., Ltd. (๿
ʮ̡), a wholly-owned subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd. ( Ϫ
ʮ̡), a pharmaceutical company listed on the Shanghai Stock Exchange
(stock code: 600276). From March 2005 to October 2011, he served as an investigator at
Novartis Institutes of Biomedical Research, a pharmaceutical research organization of Novartis
AG, a medicines company.
Dr. Lan received his bachelor’s degree in organic chemistry from Lanzhou University ( ᚆ
ψɽኪ) in China in 1994 and Doctor of Science degree in organic chemistry from Lanzhou
University ( ᚆψɽኪ) in China in June 1999. After receiving his Doctor of Science degree, he
continued his research in organic synthetic chemistry at University of Rochester in the United
States.
Ms. ZHANG Wei ( ੵᙯ), aged 46, is our executive Director, secretary to the Board and
a joint company secretary. Ms. Zhang is responsible for supervising financing and investment
related matters of our Group. Ms. Zhang joined the Group in August 2017 when the Company
was established and was then appointed as a Director on November 25, 2024. Prior to joining
our Group, Ms. Zhang has worked in different companies in the biotechnology and
pharmaceutical related field, where she had gained knowledge and experience in project
management in the industry. She had also gained insight in business development related
matters from potential investors in the industry through her prior working experience. Such
experience and knowledge allow her to provide valuable insights and support to the pre-IPO
financing and investment related matters of the Group. She was responsible in leading each
round of the pre-IPO financings conducted by the Company.
From October 2009 to December 2016, she worked at PerkinElmer Enterprise
Management (Shanghai) Co., Ltd. (ဧᎰΆุ၍ଣ(ɪऎ)ʮ̡), a company primarily
engaged in the provision of analytical and enterprise solutions in various aspects, including but
not limited to medical device testing solutions, laboratory services solutions and forensics and
toxicology solutions. She was responsible for new products launch and solutions and
technology application. Before she joined PerkinElmer Enterprise Management (Shanghai)
Co., Ltd. and since August 2009, she worked at WuXi AppTec (Shanghai) Co., Ltd. (׼
ʮ̡), a wholly-owned subsidiary of Wuxi Apptec Co., Ltd. (ੰᅃ
ʮ̡), a pharmaceutical company listed on the Shanghai Stock Exchange
(stock code: 603259) and the Hong Kong Stock Exchange (stock code: 2359). From December
2006 to August 2009, she served as a research assistant at Shanghai Genomics Inc. (݋
ʮ̡), a biopharmaceutical company.
Ms. Zhang received her bachelor’s degree in chemical engineering in July 2000 and a
bachelor’s degree in English language in July 2001 from Dalian University of Technology ( ɽ
ஹଣʈɽኪ) in China. She received a master’s degree in biology and biotechnology from Lille
1 University in France in September 2006. She obtained a master’s degree in science, health
and applications, with a focus on structure, proteomics, and functional genomics from
Université Paris VII in France in March 2007.
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Non-executive Directors
Mr. ZHU Jingyang ( ϡᘩජ) (formerly named ZHU Daqiang ( ϡɽ੶)), aged 36, is our
non-executive Director. Mr. Zhu is responsible for providing strategic advice and making
recommendation on the operation and management of our Group. Mr. Zhu was appointed as a
Director on August 1, 2022.
Mr. Zhu has ample experiences in investment management. He is currently an investment
director at HuaGai Healthcare Fund (ږof HuaGai Capital ( ശႊ༟͉).
Mr. Zhu obtained a master’s degree in medicine in microbiology and biochemical
pharmacy from Peking Union Medical College ( ̏ԯ՘ձᔼኪ৫), Tsinghua University School
of Medicine ( ૶ശɽኪᔼኪ௅) in China in January 2014.
Ms. TAO Sha ( ௗ୶), aged 31, is our non-executive Director. Ms. Tao is responsible for
providing strategic advice and making recommendation on the operation and management of
our Group. Ms. Tao was appointed as a Director on November 25, 2024.
Ms. Tao is currently a vice president at Shanghai CDH Futai V enture Capital Management
Co., Ltd. (ʮ̡), a fund manager under CDH Investments ( ཻ
ฯҳ༟), an asset management group focusing on investment in China.
Ms. Tao received her dual bachelor’s degrees in business and biochemistry from Brandeis
University in the United States in February 2017. She received her master’s degree in strategic
management from HEC Paris in France in March 2019.
Independent non-executive Directors
Ms. Christine Shaohua LU-WONG ( ጅჭശ), aged 56, is appointed as our independent
non-executive Director with effect from the Listing Date. Ms. Lu-Wong is responsible for
advising our Group on issues relating to corporate governance, audit and providing
independent opinion to the Board.
Ms. Lu-Wong brings invaluable senior executive leadership and experiences in corporate
financial strategy and governance. She is also qualified as a certified public accountant in the
United States. She held various senior management positions at various listed companies,
including vice president of finance at WuXi PharmaTech (Cayman) Inc. (NYSE ticker before
delisting: WX) from August 2007 to August 2009, executive vice president and chief financial
officer at Pactera Technology International Ltd. (NASDAQ ticker before delisting: PACT) from
January 2010 to November 2012, chief financial officer at Xueda Education Group (NYSE
ticker before delisting: XUE) from November 2012 to December 2015, and chief financial
officer at WuXi Biologics (Cayman) Inc., a company listed on the Hong Kong Stock Exchange
(stock code: 02269.HK) from January 2016 to November 2021.
She has been serving the independent non-executive director and chairwoman of the audit
committee at WuXi AppTec Co., Ltd. (ʮ̡), a company listed
on the Shanghai Stock Exchange (stock code: 603259.SH) and Hong Kong Stock Exchange
(stock code: 02359.HK) since May 2023 and June 2023, respectively.
Ms. Lu-Wong obtained a bachelor’s degree in foreign trade and economics from
Guangdong University of Foreign Studies (̮Ⴇ̮൱ɽኪ) in China in July 1990 and an
MBA degree in accounting from Golden Gate University in the United States in April 1994.
DIRECTORS, SUPERVISORS AND SENIOR MANAGEMENT
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Dr. ZHOU Demin ( մᅃઽ), aged 59, is appointed as our independent non-executive
Director with effect from the Listing Date. Dr. Zhou is responsible for advising our Group on
issues relating to corporate governance, audit and providing independent opinion to the Board.
Dr. Zhou has served as a professor of Peking University School of Pharmaceutical
Sciences ( ̏ԯɽኪᖹኪ৫) since September 2008, where he consecutively served as the
deputy dean from December 2009 to January 2016 and the dean from January 2016 to July
2023. He is currently the director of State Key Laboratory of Natural and Biomimetic Drugs
(܃.)
Dr. Zhou has been serving as an independent non-executive director of Hangzhou Jiuyuan
Gene Engineering Co., Ltd. (ʮ̡) (a company listed on the Hong
Kong Stock Exchange (stock code: 2566)) since November 2023; an independent director of
Chengdu Kanghong Pharmaceutical Group Co., Ltd. (ʮ̡)( a
company listed on the Shenzhen Stock Exchange (stock code: 002773)) since August 2023; an
independent non-executive director of Lepu Biopharma Co., Ltd. (ʮ̡)
(a company listed on the Hong Kong Stock Exchange (stock code: 2157)) since December
2020. He was an independent director of North China Pharmaceutical Co, Ltd. (΅
ʮ̡) (a company listed on the Shanghai Stock Exchange (stock code: 600812)) from May
2019 to May 2025.
Dr. Zhou obtained bachelor’s degree in chemistry from the pharmaceutical college of
Beijing Medical University (ɽኪ) (currently known as Peking University Health
Science Center ( ̏ԯɽኪᔼኪ௅)) in China in July 1990 and a Doctor of Science from the
same university in June 1996. Dr. Zhou has been certified by Peking University ( ̏ԯɽኪ)a s
a professor since September 2008. Dr. Zhou was also recognized as “973 Chief Scientist” (973
࢕by Ministry of Science and Technology of the PRC (ኪҦஔ௅)
in 2010, and “Changjiang Scholar Distinguished Professor” (त໌઺બ) by Ministry
of Education of the PRC ( ʕശɛ͏΍ձ਷઺ԃ௅) in 2013. He is also a vice chairman of the
council of Beijing Pharmaceutical Society ( ̏ԯᖹኪึ) and a member of the professional
committee on pharmaceutical chemistry of Chinese Pharmaceutical Association ( ʕ਷ᖹኪึ).
M r .L IB o(ت)aged 54, is appointed as our independent non-executive Director with
effect from the Listing Date. Mr. Li is responsible for advising our Group on issues relating to
corporate governance, audit and providing independent opinion to the Board.
Mr. Li has ample experiences in asset management. Mr. Li has been serving as the partner
of Shanghai Real Estate Asset Management Co., Ltd. ( ɪໄ༟ପ၍ଣ(ɪऎ)ʮ̡) since
April 2023.
Mr. Li served as an independent director of Shanghai Chuangxin Resources Development
Co., Ltd. (ʮ̡), a company listed on the Shanghai Stock Exchange
(stock code: 600193), from July 2021 to May 2023.
Mr. Li received his bachelor’s degree in hoisting, transporting, and engineering
machinery from Hebei Coal Construction Engineering College (ጘʈ೻ኪ৫)
(currently known as Hebei University of Engineering (̏ʈ೻ɽኪ)) in China in July 1994.
He received his master’s degree in engineering science from Shanghai Jiao Tong University ( ɪ
ऎʹஷɽኪ) in China in February 1997.
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SUPERVISORY COMMITTEE
Our Supervisory Committee currently consists of three supervisors, one of whom is the
chairperson of our Supervisory Committee.
Each of the Supervisors is appointed for a term of three years which is renewable upon
re-election and re-appointment. Pursuant to the Articles of Association, the functions and
powers of our Supervisory Committee include, but not limited to, reviewing the financial
management of our Company, monitoring the performance of duties of our Directors and senior
management members, and requesting Directors and senior management members to rectify
actions detrimental to our Company’s interests. In addition, our Supervisory Committee is
responsible for exercising other powers, functions and duties in accordance with the Articles
of Association, and all applicable laws and regulations. The following table sets forth the key
information of our Supervisors:
Name Age Position/Title
Date of
Appointment as
a Supervisor
Date of Joining
Our Group
Roles and
Responsibilities
Mr. XUE
Mengjun
(ࠏ֗)H1118/H1118/H1118/H1118
53 Shareholders’
representative
Supervisor
August 2022 August 2022 Supervising the
performance of our
Directors and
members of senior
management, and
performing other
supervisory duties
Mr. LIN
Chonglan
(ਫ਼ᖀ) /H1118/H1118/H1118/H1118
42 Employees’
representative
Supervisor
September 2024 July 2019 Supervising the
performance of our
Directors and
members of senior
management, and
performing other
supervisory duties
Ms. MA Rui
(৵ြ) /H1118/H1118/H1118/H1118/H1118/H1118
33 Employees’
representative
Supervisor
September 2024 March 2019 Supervising the
performance of our
Directors and
members of senior
management, and
performing other
supervisory duties
DIRECTORS, SUPERVISORS AND SENIOR MANAGEMENT
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Supervisors
Mr. XUE Mengjun (ࠏ֗)aged 53, is our Supervisor. He is responsible for
supervising the performance of our Directors and members of senior management, and
performing other supervisory duties. Mr. Xue was appointed as a Supervisor in August 2022.
Mr. Xue has ample experiences in investment management. Since September 2010, he has
been serving as the managing partner of Shanghai Panlin Asset Management Co., Ltd. ( ɪऎ
ʮ̡), an asset management and investment firm focusing on investment in
Healthcare and Biotechnology field as well as To B and Technology field.
Mr. Xue received his bachelor’s degrees in statistics and economics from Shanghai
University of Finance and Economics ( ɪऎৌ຾ɽኪ) in China in July 1994.
Mr. LIN Chonglan (ਫ਼ᖀ), aged 42, is our Supervisor. He is responsible for
supervising the performance of our Directors and members of senior management, and
performing other supervisory duties. Mr. Lin was appointed as a Supervisor in September 2024.
Mr. Lin joined the Company in July 2019 as a manager and senior researcher of the R&D
department.
Mr. Lin has more than 15 years of experiences in chemical and pharmaceutical industry.
From August 2017 to July 2019, he worked at Shanghai Haiyan Pharmaceutical Technology
Co., Ltd. (ʮ̡), a wholly-owned subsidiary of Y angtze River
Pharmaceutical Group Co., Ltd. (ʮ̡), a pharmaceutical company. From
March 2008 to August 2017, he worked successively at Shanghai ChemExplorer Co., Ltd. ( ɪ
ʮ̡) and Shanghai ChemPartner Co., Ltd. (ӺϞ
ʮ̡).
Mr. Lin received his bachelor’s degree in chemistry from Wenzhou University ( ๝ψɽኪ)
in China in June 2005 and his master’s degree in organic chemistry from Sun Y at-sen
University ( ʕʆɽኪ) in China in June 2007.
Ms. MA Rui ( ৵ြ), aged 33, is our Supervisor. Ms. Ma is responsible for supervising the
performance of our Directors and members of senior management, and performing other
supervisory duties. Ms. Ma was appointed as a Supervisor in September 2024. Ms. Ma joined
the Company in March 2019 and is currently the deputy manager of human resources.
Ms. Ma has ample experiences in human resources management. Prior to joining the
Group, she served as a human resources specialist at Shanghai Shoen International Trade Co.,
Ltd. (ʮ̡), a company focusing on the manufacturing and supply of
new energy related products and parts from May 2017 to March 2019. From October 2014 to
May 2017, she worked at Shanghai Haiyan Pharmaceutical Technology Co., Ltd. ( ɪऎऎඨᔼ
ʮ̡), a wholly owned subsidiary of Y angtze River Pharmaceutical Group Co., Ltd.
(ʮ̡), a pharmaceutical company.
Ms. Ma received her bachelor’s degree in e-commerce from Anhui University Jianghuai
College ( τᏏɽኪϪଊኪ৫) in China in July 2013.
DIRECTORS, SUPERVISORS AND SENIOR MANAGEMENT
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SENIOR MANAGEMENT
The following table sets out information regarding the members of senior management of
our Company.
Name Age Position/Title
Date of
Appointment as
a Senior
Management
Date of Joining
Our Group
Roles and
Responsibilities
Dr. Qiang LU /H1118/H1118/H111859 Executive Director
and Chairman of
the Board
August 2017 August 2017 Overall strategic
planning, financial
management, and
business management
of our Group
Dr. Jiong LAN /H1118/H111853 Executive Director,
Chief Executive
Officer and General
Manager
August 2017 August 2017 Overall supervision and
management of the
business operation of
our Group
Ms. ZHANG Wei
(ੵᙯ) /H1118/H1118/H1118/H1118/H1118/H1118
46 Executive Director,
secretary to the
Board and joint
company secretary
August 2017 August 2017 Supervision of
financing and
investment related
matters of our Group
Dr. W ANG Y u
(ӓ༃) /H1118/H1118/H1118/H1118/H1118/H1118
53 Chief Medical Officer November 2020 November 2020 Supervision of our
clinical development
strategy and
execution, and our
whole R&D strategy
and project planning
For biographical details of Dr. Lu, Dr. Lan and Ms. Zhang, see “— Executive Directors”
in this section. The details of the other senior management member are set out below:
Dr. W ANG Yu (ӓ༃), aged 53, is our Chief Medical Officer. Dr. Wang is responsible for
the supervision of our clinical development strategy and execution, and our whole R&D
strategy and project planning. Dr. Wang joined the Group as the Chief Medical Officer in
November 2020. Dr. Wang was appointed as a Director in December 2020 and has resigned
from directorship with effect before Listing to streamline and adjust the Board and
management structure upon Listing.
Dr. Wang has over 20 years of experiences in the antitumor drug development and the
pharmaceutical industry. Prior to joining the Group, he served as consulting partner of
ZenRhyme Consulting Services Co., Ltd. ( ༉Ѹ(ɪऎ)ʮ̡) from January
2018 to October 2020, and chief medical officer of Abbisko Therapeutics (ᔼᖹ
ʮ̡), a wholly-owned subsidiary of Abbisko Cayman Limited, a company listed on
the Hong Kong Stock Exchange (stock code: 2256) from March 2020. From November 2016
to December 2017, he served as chief scientist of Beijing Panacro Pharmaceutical Technology
Co., Ltd. (ʮ̡), a contract research organization specializing in
DIRECTORS, SUPERVISORS AND SENIOR MANAGEMENT
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pharmaceutical R&D and clinical research. From September 2013 to November 2016, he
served as clinical program leader, oncology translational medicine of China Novartis Institutes
for Biomedical Research Co., Ltd. ( ፕശ(ʕ਷)Ӻʕː). From April 2012 to
September 2013, he served as clinical research director of Sanofi (China) Investment Co., Ltd.
Shanghai Branch ( ᒄፕി(ʕ਷)ʮ̡ɪऎʱʮ̡). From February 2010 to March
2012, he served as a medical director at GlaxoSmithKline (China) Investment Co., Ltd. ( ໤ᚆ
९̦д(ʕ਷)ʮ̡), a subsidiary of GSK PLC, a company listed on the London Stock
Exchange (stock code: GSK) and New Y ork Stock Exchange (stock code: GSK). From April
2007 to February 2010, he served as an associate medical director at Eli Lilly Asia, Inc.
Shanghai Rep. Office (ஈ). From April 2005 to April 2007, he
served as a senior research fellow at Shanghai Sunway Biotech Co., Ltd. (Ҧஔ
ʮ̡). From July 2000 to January 2001, he worked at the Shanghai Huadong Hospital ( ɪ
ᔼ৫).
Dr. Wang received his medical degree in clinical medicine from Tongji Medical
University (ɽኪ), which is now known as Tongji Medical College of Huazhong
University of Science and Technology (ҦɽኪΝ᏶ᔼኪ৫) in China in June 1995. He
received a doctorate degree in surgery from Shanghai Medical University (ɽኪ),
which is now known as Shanghai Medical College of Fudan University ( ూ͇ɽኪɪऎᔼኪ৫)
in China in June 2000 and was a post-doctorate fellow in oncology at the Barbara Ann
Karmanos Cancer Institute of the Wayne State University in the United States from July 2001
to August 2004.
CONFIRMATION FROM OUR DIRECTORS
Rule 8.10 of the Listing Rules
Each of our Directors confirms that as of the Latest Practicable Date, he or she did not
have any interest in a business which competes or is likely to compete, either directly or
indirectly, with our Company’s business which would require disclosure under Rule 8.10 of the
Listing Rules.
Rule 3.09D of the Listing Rules
Each of our Directors confirms that he or she (i) has obtained the legal advice referred
to under Rule 3.09D of the Listing Rules in December 2024, and (ii) understands his or her
obligations as a director of a listed issuer under the Listing Rules.
Rule 3.13 of the Listing Rules
Each of the independent non-executive Directors has confirmed (i) his/her independence
as regards each of the factors referred to in Rules 3.13(1) to (8) of the Listing Rules, (ii) he/she
has no past or present financial or other interest in the business of the Company or its
subsidiaries or any connection with any core connected person of the Company under the
Listing Rules as of the Latest Practicable Date, and (iii) that there are no other factors that may
affect his/her independence at the time of his/her appointments.
DIRECTORS, SUPERVISORS AND SENIOR MANAGEMENT
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GENERAL
Save as disclosed above, none of the Directors, Supervisors or members of senior
management of our Company has been a director of any public company the securities of which
are listed on any securities market in Hong Kong or overseas in the three years immediately
preceding the date of this Prospectus.
None of the Directors, Supervisors or members of the senior management of our
Company is related to any other Directors, Supervisors and members of the senior management
of our Company.
None of the Directors, Supervisors or members of the senior management of our
Company has completed his/her respective education programs as disclosed in this section by
way of attendance of long distance learning or online courses.
Save as disclosed herein, to the best knowledge, information and belief of our Directors
and Supervisors having made all reasonable inquiries, there was no other matter with respect
to the appointment of our Directors or Supervisors that needs to be brought to the attention of
the Shareholders and there was no information relating to our Directors or Supervisors that is
required to be disclosed pursuant to Rule 13.51(2)(h) to (v) of the Listing Rules as of the Latest
Practicable Date.
JOINT COMPANY SECRETARIES
Ms. Zhang was appointed as our joint company secretary in November 2024. For further
details, see “— Executive Directors” above.
Mr. NG Tung Ching Raphael (ᆋ), was appointed as our joint company secretary in
November 2024. Mr. Ng is a seasoned professional with over 14 years of extensive experience
in the legal and company secretarial domains, specializing in corporate governance and
compliance. He currently serves as the assistant vice president of Computershare Hong Kong
Investor Services Limited.
Mr. Ng holds a master’s degree in Chinese business law from the Chinese University of
Hong Kong and a master’s degree in professional accounting and corporate governance from
The City University of Hong Kong. He earned his bachelor’s degree in law from Manchester
Metropolitan University. Mr. Ng is an associate member of both The Hong Kong Chartered
Governance Institute (the “ HKCGI ,” formerly known as the Hong Kong Institute of Chartered
Secretaries) and The Chartered Governance Institute in the United Kingdom. He also possesses
the practitioner’s endorsement from HKCGI.
DIRECTORS, SUPERVISORS AND SENIOR MANAGEMENT
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BOARD COMMITTEES
Our Board delegates certain responsibilities to various committees. In accordance with
the relevant PRC laws and regulations and the Corporate Governance Code as set out in the
Appendix C1 to the Listing Rules, our Company has formed three Board committees, namely
the Audit Committee, the Remuneration Committee and the Nomination Committee.
Audit Committee
We have established an Audit Committee with written terms of reference in compliance
with Rule 3.21 of the Listing Rules and paragraph D.3 of Part 2 of the Corporate Governance
Code. The Audit Committee consists of three Directors, namely Ms. Christine Shaohua
LU-WONG, Mr. ZHU Jingyang and Dr. ZHOU Demin. Ms. Christine Shaohua LU-WONG,
who holds the appropriate professional qualifications as required under Rules 3.10(2) and 3.21
of the Listing Rules, serves as the chairperson of the Audit Committee. The primary duties of
the Audit Committee include, but not limited to, the following:
 proposing the appointment or change of external auditors to our Board, and
monitoring the independence of external auditors and evaluating their performance;
 guiding internal audit work;
 examining the financial information of our Company, reviewing financial reports
and statements of our Company and giving comments on relevant matters;
 assessing the effectiveness of internal control;
 coordinating the communication among management, internal audit department,
related departments and external audit agency; and
 dealing with other matters that are authorized by the Board or involved in relevant
laws and regulations.
DIRECTORS, SUPERVISORS AND SENIOR MANAGEMENT
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Remuneration Committee
We have established a Remuneration Committee with written terms of reference in
compliance with Rule 3.25 of the Listing Rules and paragraph E.1 of Part 2 of the Corporate
Governance Code. The Remuneration Committee consists of three Directors, namely Mr. LI
Bo, Dr. Lan and Dr. ZHOU Demin. Mr. LI Bo serves as the chairperson of the Remuneration
Committee. The primary duties of the Remuneration Committee include, but not limited to, the
following:
 formulating individual remuneration plans for Directors and members of the senior
management in accordance with the terms of reference of the job responsibilities,
the importance of their positions as well as the remuneration benchmarks for the
relevant positions in other comparable companies;
 examining the criteria of performance evaluation of Directors and the senior
management of our Company, and conducting annual performance evaluation;
 supervising the implementation of the remuneration plan of the Company;
 reviewing and/or approving matters relating to share schemes under Chapter 17 of
the Listing Rules; and
 dealing with other matters that are authorized by the Board.
Nomination Committee
We have established a Nomination Committee with written terms of reference in
compliance with Rule 3.27A of the Listing Rules and paragraph B.3 of Part 2 of the Corporate
Governance Code. The Nomination Committee consists of three Directors, namely Dr. Lu, Ms.
Christine Shaohua LU-WONG and Mr. LI Bo. Dr. Lu serves as the chairperson of the
Nomination Committee. The primary duties of the Nomination Committee include, but not
limited to, the following:
 making recommendations to our Board with regards to the size and composition of
our Board based on our Company’s business operation, asset scale and equity
structure;
 researching and developing standards and procedures for the election of our Board
members, general managers and members of the senior management, and making
recommendations to our Board;
 conducting extensive search and providing to our Board suitable candidates for
Directors, general managers and other members of the senior management;
DIRECTORS, SUPERVISORS AND SENIOR MANAGEMENT
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 examining our Board candidates, general manager and members of the senior
management and making recommendations to our Board;
 assessing and reviewing the independence of independent non-executive Directors;
and
 dealing with other matters that are authorized by our Board.
REMUNERATION OF DIRECTORS AND SUPERVISORS
For more information on the remuneration of the Directors, Supervisors and chief
executive during the Track Record Period as well as information on the five highest paid
individuals, please see Notes 10 and 11 of the Accountants’ Report set out in Appendix I.
Under the arrangement currently in force, we estimate the remuneration of our Directors
and our Supervisors for the year ending December 31, 2025 to be approximately RMB7.2
million.
During the Track Record Period, no remuneration was paid by our Company to, or
receivable by, our Directors, Supervisors or the five highest paid individuals as an inducement
to join or upon joining our Company or as compensation for loss of office in connection with
the management positions of any subsidiary of our Company.
During the Track Record Period, none of our Directors or Supervisors waived any
remuneration. Save as disclosed above, no other payments have been paid, or are payable, by
our Company or any of our subsidiary to our Directors, Supervisors or the five highest paid
individuals during the Track Record Period.
CORPORATE GOVERNANCE CODE
Our Company is committed to achieving high standards of corporate governance with a
view to safeguarding the interests of our Shareholders. To accomplish this, our Company
intends to comply with Corporate Governance Code set out in Appendix C1 to the Listing
Rules and the Model Code for Securities Transactions by Directors of Listed Issuers set out in
Appendix C3 to the Listing Rules after the Listing. Our Directors consider that upon Listing,
we will comply with all applicable code provisions of the Corporate Governance Code as set
out in Appendix C1 to the Listing Rules.
DIRECTORS, SUPERVISORS AND SENIOR MANAGEMENT
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--- page 486 ---
BOARD DIVERSITY POLICY
We are committed to promoting the culture of diversity in the Company. We have strived
to promote diversity to the extent practicable by taking into consideration a number of factors
in our corporate governance structure.
We have adopted the board diversity policy (the “ Board Diversity Policy ”) which sets
out the objective and approach to achieve and maintain diversity of our Board in order to
enhance the effectiveness of our Board. Pursuant to the board diversity policy, we seek to
achieve Board diversity through the consideration of a number of factors, including but not
limited to gender, age, race, cultural background, educational background, industry experience
and professional experience. Our Directors have a balanced mix of knowledge and skills,
including knowledge and experience in the areas of biotechnology, pharmaceutical, chemistry,
and investment banking. They obtained degrees in various areas including biology, chemistry,
economics and business. Our Board Diversity Policy is well implemented as evidenced by the
fact that there are Directors ranging from 31 years old to 59 years old and comprises three
female Directors and five male Directors. We will use our best efforts to maintain at least one
or 10% female representation in the Board and continue to take steps to promote diversity at
all levels of the Company including but without limitation to our Board and senior management
levels, to enhance the effectiveness of corporate governance of the Company as a whole. Going
forward, we will continue to work to enhance gender diversity of our Board when selecting and
recommending suitable candidates for Board appointments.
Our Nomination Committee is responsible for ensuring the diversity of our Board
members. After the Listing, our Nomination Committee will examine the board diversity policy
from time to time to ensure its continued effectiveness and we will disclose in our corporate
governance report about the implementation of the board diversity policy on an annual basis.
COMPLIANCE ADVISOR
We have appointed Guotai Junan Capital Limited as our Compliance Advisor pursuant to
Rules 3A.19 and 3A.23 of the Listing Rules. The Compliance Advisor will provide us with
guidance and advice as to compliance with the Listing Rules and other applicable laws, rules,
codes and guidelines. Pursuant to Rule 3A.23 of the Listing Rules, the Compliance Advisor
will advise our Company in certain circumstances including:
(a) before the publication of any regulatory announcement, circular or financial report;
(b) where a transaction, which might be a notifiable or connected transaction, is
contemplated, including share issues and share repurchases;
(c) where we propose to use the proceeds of the Global Offering in a manner different
from that detailed in this Prospectus or where our business activities, developments
or results deviate from any forecast, estimate or other information in this Prospectus;
and
DIRECTORS, SUPERVISORS AND SENIOR MANAGEMENT
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(d) where the Hong Kong Stock Exchange makes an inquiry to our Company regarding
unusual movements in the price or trading volume of its listed securities or any other
matters in accordance with Rule 13.10 of the Listing Rules.
Pursuant to Rule 3A.24 of the Listing Rules, the Compliance Advisor will, on a timely
basis, inform our Company of any amendment or supplement to the Listing Rules that are
announced by the Hong Kong Stock Exchange. The Compliance Advisor will also inform our
Company of any new or amended law, regulation or code in Hong Kong applicable to us, and
advise us on the continuing requirements under the Listing Rules and applicable laws and
regulations.
The term of the appointment will commence on the Listing Date and is expected to end
on the date on which our Company complies with Rule 13.46 of the Listing Rules in respect
of our financial results for the first full financial year commencing after the Listing.
DIRECTORS, SUPERVISORS AND SENIOR MANAGEMENT
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SUBSTANTIAL SHAREHOLDERS
So far as our Directors are aware, immediately following the completion of the Global
Offering and the conversion of our Unlisted Shares to H Shares assuming the Over-allotment
Option is not exercised, the following persons will have an interest and/or short position in the
Shares or the underlying Shares which would fall to be disclosed to us and the Stock Exchange
under the provisions of Divisions 2 and 3 of Part XV of the SFO, or, will be, directly or
indirectly interested in 10% or more of the nominal value of any class of our share capital
carrying rights to vote in all circumstances at general meetings of our Company:
Name of Shareholder Nature of Interest
As of the Latest Practicable
Date without taking into
account the Share Subdivision
Immediately following the
Global Offering (taking into account
the Share Subdivision and assuming
the Offer Size Adjustment Option and the Over-
allotment Option are not exercised)
Number
of Unlisted
Shares
Approximate
percentage of
shareholding
in our total
share capital
Number of
Shares (1)
Approximate
percentage of
shareholding
in Unlisted
Shares/
H Shares (2)
Approximate
percentage of
shareholding
in our total
share capital (2)
Dr. Lu /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Interest in controlled
corporations
1,383,607 (3) 5.17% 13,836,070
H Shares (L)
4.42% 4.01%
5,372,465 (4) 20.06% 53,724,650
H Shares (L)
17.16% 15.56%
Dr. Lan /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Interest in controlled
corporations
5,372,465 (4) 20.06% 53,724,650
H Shares (L)
17.16% 15.56%
GenFleet HK (4) /H1118/H1118/H1118/H1118Interest in controlled
corporations
1,000,000 3.73% 10,000,000
H Shares (L)
3.19% 2.90%
Beneficial owner 4,372,465 16.33% 43,724,650
H Shares (L)
13.97% 12.66%
Ourea Biotech (5) /H1118/H1118/H1118Beneficial owner 2,241,889 8.37% 22,418,890
H Shares (L)
7.16% 6.49%
HL Partners II L.P . (5) /H1118Interest in controlled
corporations
2,241,889 8.37% 22,418,890
H Shares (L)
7.16% 6.49%
HL GP II Company
Limited (5) /H1118/H1118/H1118/H1118/H1118/H1118
Interest in controlled
corporations
2,241,889 8.37% 22,418,890
H Shares (L)
7.16% 6.49%
Long Star (6) /H1118/H1118/H1118/H1118/H1118/H1118Beneficial owner 1,509,115 5.64% 15,091,150
H Shares (L)
4.82% 4.37%
CDH Growth Fund
III (USD Parallel),
L.P .
(6) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Interest in controlled
corporations
1,509,115 5.64% 15,091,150
H Shares (L)
4.82% 4.37%
CDH R-III Parallel
Holdings Company
Limited
(6) /H1118/H1118/H1118/H1118/H1118
Interest in controlled
corporations
1,509,115 5.64% 15,091,150
H Shares (L)
4.82% 4.37%
SUBSTANTIAL SHAREHOLDERS
– 479 –


--- page 489 ---
Name of Shareholder Nature of Interest
As of the Latest Practicable
Date without taking into
account the Share Subdivision
Immediately following the
Global Offering (taking into account
the Share Subdivision and assuming
the Offer Size Adjustment Option and the Over-
allotment Option are not exercised)
Number
of Unlisted
Shares
Approximate
percentage of
shareholding
in our total
share capital
Number of
Shares (1)
Approximate
percentage of
shareholding
in Unlisted
Shares/
H Shares (2)
Approximate
percentage of
shareholding
in our total
share capital (2)
Hongyong Bingde (7) /H1118Beneficial owner 1,317,182 4.92% 13,171,820
Unlisted
Shares (L)
40.73% 3.81%
Hongyong Bingde
Capital (Cayman)
Limited
(7) /H1118/H1118/H1118/H1118/H1118/H1118
Interest in controlled
corporations
1,317,182 4.92% 13,171,820
Unlisted
Shares (L)
40.73% 3.81%
Sinopharm (8) /H1118/H1118/H1118/H1118/H1118Beneficial owner 947,615 3.54% 4,738,075
H Shares (L)
1.51% 1.37%
4,738,075
Unlisted
Shares (L)
14.65% 1.37%
Shanghai Jianyi
Private Fund
Management Co.,
Ltd.
(8) /H1118/H1118/H1118/H1118/H1118/H1118/H1118
Interest in controlled
corporations
947,615 3.54% 4,738,075
H Shares (L)
1.51% 1.37%
4,738,075
Unlisted
Shares (L)
14.65% 1.37%
CSPC NBP (9) /H1118/H1118/H1118/H1118/H1118Beneficial owner 441,176 1.65% 4,411,760
Unlisted
Shares (L)
13.64% 1.28%
CSPC Pharmaceutical
Group Limited (9) /H1118
Interest in controlled
corporations
441,176 1.65% 4,411,760
Unlisted
Shares (L)
13.64% 1.28%
Pu’en Guoxin /H1118/H1118/H1118/H1118/H1118Beneficial owner 395,607 1.48% 3,956,070
Unlisted
Shares (L)
12.23% 1.15%
Huajin Lingjian (10) /H1118/H1118Beneficial owner 470,271 1.76% 2,351,360
H Shares (L)
0.75% 0.68%
2,351,350
Unlisted
Shares (L)
7.27% 0.68%
Zhuhai Huajin
Lingchuang Fund
Management Co.,
Ltd.
(10) /H1118/H1118/H1118/H1118/H1118/H1118/H1118
Interest in controlled
corporations
470,271 1.76% 2,351,360
H Shares (L)
0.75% 0.68%
2,351,350
Unlisted
Shares (L)
7.27% 0.68%
SUBSTANTIAL SHAREHOLDERS
– 480 –


--- page 490 ---
Name of Shareholder Nature of Interest
As of the Latest Practicable
Date without taking into
account the Share Subdivision
Immediately following the
Global Offering (taking into account
the Share Subdivision and assuming
the Offer Size Adjustment Option and the Over-
allotment Option are not exercised)
Number
of Unlisted
Shares
Approximate
percentage of
shareholding
in our total
share capital
Number of
Shares (1)
Approximate
percentage of
shareholding
in Unlisted
Shares/
H Shares (2)
Approximate
percentage of
shareholding
in our total
share capital (2)
Zhuhai Huajin Alpha
No. 6 Equity
Investment Fund
Partnership
(Limited
Partnership)
(10) /H1118/H1118/H1118
Interest in controlled
corporations
470,271 1.76% 2,351,360
H Shares (L)
0.75% 0.68%
2,351,350
Unlisted
Shares (L)
7.27% 0.68%
Zhuhai Huaying
Investment Co.,
Ltd.
(10) /H1118/H1118/H1118/H1118/H1118/H1118/H1118
Interest in controlled
corporations
470,271 1.76% 2,351,360
H Shares (L)
0.75% 0.68%
2,351,350
Unlisted
Shares (L)
7.27% 0.68%
Huajin Capital (10) /H1118/H1118Interest in controlled
corporations
470,271 1.76% 2,351,360
H Shares (L)
0.75% 0.68%
2,351,350
Unlisted
Shares (L)
7.27% 0.68%
BOCOM Sci-Tech (11) /H1118Beneficial owner 189,048 0.71% 1,890,480
Unlisted
Shares (L)
5.85% 0.55%
Shanghai Boli
Investment Co.,
Ltd.
(11) /H1118/H1118/H1118/H1118/H1118/H1118/H1118
Interest in controlled
corporations
189,048 0.71% 1,890,480
Unlisted
Shares (L)
5.85% 0.55%
BOCOM International
Holdings Company
Limited
(11) /H1118/H1118/H1118/H1118/H1118
Interest in controlled
corporations
189,048 0.71% 1,890,480
Unlisted
Shares (L)
5.85% 0.55%
Notes:
1. The letter “L” denotes the person’s long position in the Shares.
2. The calculation is based on the total number of 32,337,610 Unlisted Shares and 313,003,020 H Shares in issue
immediately after completion of the Global Offering since 235,403,020 Unlisted Shares will be converted into
H Shares and 77,600,000 H Shares will be issued pursuant to the Global Offering, taking into account the Share
Subdivision and assuming that the Offer Size Adjustment Option and the Over-allotment Option are not
exercised.
3. Shanghai Kunjin is our ESOP Platform. As of the Latest Practicable Date, Shanghai Kunjin is deemed to be
controlled by Dr. Lu as its sole general partner, and none of the limited partners of Shanghai Kunjin held more
than one-third of the partnership interest in Shanghai Kunjin. Therefore, by virtue of the SFO, Dr. Lu is deemed
to be interested in the Shares held by Shanghai Kunjin.
SUBSTANTIAL SHAREHOLDERS
– 481 –


--- page 491 ---
4. Auspicious Delight is our ESOP Platform. As at the Latest Practicable Date, GenFleet HK was held as to
53.69% by Dr. Lu and 46.31% by Dr. Lan. GenFleet HK held 64.5% of the issued share capital of Auspicious
Delight. Therefore, by virtue of the SFO, each of Dr. Lu and Dr. Lan is deemed to be interested in the Shares
held by GenFleet HK and Auspicious Delight.
5. Ourea Biotech is controlled by HL Partners II L.P ., a limited partnership established under the laws of the
Cayman Islands, which is ultimately managed by its general partner, HL GP II Company Limited. Therefore,
by virtue of the SFO, each of HL Partners II L.P . and HL GP II Company Limited is deemed to be interested
in the Shares held by Ourea Biotech.
6. Long Star is indirectly wholly owned by CDH Growth Fund III (USD Parallel), L.P ., a limited partnership
incorporated in the Cayman Islands. The general partner of CDH Growth Fund III (USD Parallel), L.P . is CDH
R-III Parallel Holdings Company Limited. Therefore, by virtue of the SFO, each of CDH Growth Fund III
(USD Parallel), L.P . and CDH R-III Parallel Holdings Company Limited is deemed to be interested in the
Shares held by Long Star.
7. Hongyong Bingde is wholly-owned by Hongyong Bingde Capital (Cayman) Limited. Therefore, by virtue of
the SFO, Hongyong Bingde Capital (Cayman) Limited is deemed to be interested in the Share held by
Hongyong Bingde.
8. Shanghai Jianyi Private Fund Management Co., Ltd. is the executive partner of Sinopharm. Therefore, by
virtue of the SFO, Shanghai Jianyi Private Fund Management Co., Ltd. is deemed to be interested in the Shares
held by Sinopharm.
9. CSPC NBP is a wholly-owned subsidiary of CSPC Pharmaceutical Group Limited. Therefore, by virtue of the
SFO, CSPC Pharmaceutical Group Limited is deemed to be interested in the Shares held by CSPC NBP .
10. Huajin Lingjian is a limited partnership incorporated under the laws of the PRC, with its executive partner
being Zhuhai Huajin Lingchuang Fund Management Co., Ltd., which is a wholly-owned subsidiary of Huajin
Capital. The single largest limited partner of Huajin Lingjian is Zhuhai Huajin Alpha No. 6 Equity Investment
Fund Partnership (Limited Partnership), which holds approximately 99.80% of the partnership interests in
Huajin Lingjian. The executive partner of Zhuhai Huajin Alpha No. 6 Equity Investment Fund Partnership
(Limited Partnership) is Zhuhai Huaying Investment Co., Ltd. Therefore, by virtue of the SFO, each of Zhuhai
Huajin Lingchuang Fund Management Co., Ltd., Huajin Capital, Zhuhai Huajin Alpha No. 6 Equity Investment
Fund Partnership (Limited Partnership) and Zhuhai Huaying Investment Co., Ltd. is deemed to be interested
in the Shares held by Huajin Lingjian.
11. Shanghai Boli Investment Co., Ltd. is the executive partner of BOCOM Sci-Tech. Shanghai Boli Investment
Co., Ltd. is controlled by BOCOM International Holdings Company Limited. Therefore, by virtue of the SFO,
each of Shanghai Boli Investment Co., Ltd. and BOCOM International Holdings Company Limited is deemed
to be interested in the Shares held by BOCOM Sci-Tech.
Save as disclosed above and the section headed “Statutory and General Information —
Further Information about our Directors, Supervisors, Senior Management and Substantial
Shareholders” in Appendix IV , our Directors are not aware of any person who will,
immediately following completion of the Global Offering (assuming that the Over-allotment
Option is not exercised), have any interest and/or short position in the Shares or underlying
Shares of our Company which will be required to be disclosed to our Company and the Stock
Exchange pursuant to the provisions of Divisions 2 and 3 of Part XV of the SFO, or, who are,
directly or indirectly interested in 10% or more of the nominal value of any class of share
capital carrying rights to vote in all circumstances at general meeting of the Company or any
other member of our Group.
SUBSTANTIAL SHAREHOLDERS
– 482 –


--- page 492 ---
THE CORNERSTONE PLACING
We have entered into cornerstone investment agreements (each a “ Cornerstone
Investment Agreement ” and collectively, the “ Cornerstone Investment Agreements ”) with
the cornerstone investors set out below (each a “ Cornerstone Investor ” and collectively, the
“Cornerstone Investors ”), pursuant to which the Cornerstone Investors have agreed to,
subject to certain conditions, subscribe, or cause their designated entities to subscribe, at the
Offer Price for such number of Offer Shares (rounded down to the nearest whole board lot of
200 H Shares) that may be purchased for an aggregate amount of US$100 million (or
approximately HK$779.63 million, calculated based on the exchange rate set out in the section
headed “Information about this Prospectus and the Global Offering — Currency Translations”
in this Prospectus) (the “ Cornerstone Placing ”). The aggregate amount of the investment
contributed by the Cornerstone Investors does not include brokerage, SFC transaction levy,
AFRC transaction levy and Hong Kong Stock Exchange trading fee which the Cornerstone
Investors will pay in respect of the International Offer Shares to be subscribed by them.
Assuming an Offer Price of HK$20.39 per Offer Share, the total number of Offer Shares
to be subscribed by the Cornerstone Investors would be 38,234,000 Offer Shares. The table
below reflects the shareholding percentage immediately after the completion of the Global
Offering.
Assuming the Offer Size Adjustment Option is not exercised Assuming the Offer Size Adjustment Option is fully exercised
Assuming the Over-allotment
Option is not exercised
Assuming the Over-allotment
Option is fully exercised
Assuming the Over-allotment
Option is not exercised
Assuming the Over-allotment
Option is fully exercised
Approximate
%o ft h e
Offer Shares
Approximate
%o f
the Shares in
issue upon
completion of
the Global
Offering
Approximate
%o ft h e
Offer Shares
Approximate
%o f
the Shares in
issue upon
completion of
the Global
Offering
Approximate
%o ft h e
Offer Shares
Approximate
%o f
the Shares in
issue upon
completion of
the Global
Offering
Approximate
%o ft h e
Offer Shares
Approximate
%o f
the Shares in
issue upon
completion of
the Global
Offering
49.27% 11.07% 42.84% 10.71% 42.84% 10.71% 37.26% 10.32%
Our Company is of the view that, (i) the Cornerstone Placing will ensure a reasonable size
of solid commitment at the beginning of the marketing period of the Global Offering and will
provide confidence to the market; and (ii) by leveraging on the Cornerstone Investors’ industry
reputation and investment experience, in particular in the life sciences, healthcare and
biopharmaceutical sectors, the Cornerstone Placing will help raise the profile of our Company
and to signify that such investors have confidence in our business and prospect. Our Company
became acquainted with each of the Cornerstone Investors through the business network of our
Group or through our existing Shareholders or through the Capital Markets Intermediaries.
CORNERSTONE INVESTORS
– 483 –


--- page 493 ---
Details of the actual number of Offer Shares to be allocated to each of the Cornerstone
Investors will be disclosed in the allotment results announcement to be issued by the Company
on or around Thursday, September 18, 2025 (the “ Allotment Results Announcement ”).
The Offer Shares to be subscribed by the Cornerstone Investors will rank pari passu in
all respects with the fully paid Shares in issue and all the H Shares to be subscribed by the
Cornerstone Investors will be counted towards the public float for the purpose of Rule 8.08 of
the Listing Rules. Immediately following the completion of the Global Offering, (i) none of the
Cornerstone Investors will become a substantial shareholder of the Company; (ii) none of the
Cornerstone Investors will have any Board representation in the Company solely by virtue of
its cornerstone investment; and (iii) equity interests in the Company being beneficially owned
by the three largest public Shareholders will be less than 50% for the purpose of Rule 8.08(3)
of the Listing Rules.
Among the Cornerstone Investors, Lake Bleu Entities (as defined in this section below)
are close associates of an existing minority Shareholder of the Company. The Stock Exchange
has granted a waiver from strict compliance with the requirements under Rule 10.04 and
consent under Paragraph 1C(2) of Appendix F1 to the Listing Rules and paragraph 18 of
Chapter 2.3 of the Guide for New Listing Applicants to permit H Shares in the International
Offering to be placed to Lake Bleu Entities. For further details, please refer to the section
headed “Waivers and Exemption — Waiver and Consent in respect of Cornerstone Investment
by Close Associates of Minority Existing Shareholder.” Save as Lake Bleu Entities, to the best
knowledge of the Company, (i) each of the Cornerstone Investors is an Independent Third
Party; (ii) none of the Cornerstone Investors is accustomed to taking instructions from the
Company, the Directors, the Supervisors, chief executive of the Company, substantial
Shareholders or existing Shareholders or any of its subsidiaries or their respective close
associates in relation to the acquisition, disposal, voting, or other disposition of H Shares
registered in its name or otherwise held by it; and (iii) none of the subscription for the relevant
Offer Shares by the Cornerstone Investors is financed by the Company, the Directors, the
Supervisors, chief executive of the Company, substantial Shareholders or existing Shareholders
or any of its subsidiaries or their respective close associates for the purpose of subscription of
the Offer Shares.
The Cornerstone Placing will form part of the International Offering. Save as otherwise
disclosed in the Allotment Results Announcement (if any), the Cornerstone Investors will not
subscribe for any Offer Shares under the Global Offering other than pursuant to the
Cornerstone Investment Agreements.
CORNERSTONE INVESTORS
– 484 –


--- page 494 ---
To the best knowledge of the Company and as confirmed by each of the Cornerstone
Investors, they made their own independent decisions to enter into the Cornerstone Investment
Agreements, and their subscriptions under the Cornerstone Investment would be financed by
their own internal resources. The Cornerstone Investors have also confirmed that all necessary
approvals have been obtained with respect to the Cornerstone Investment and that no specific
approval from any stock exchange (if relevant) or their shareholders is required for the
Cornerstone Investment. Other than a guaranteed allocation of the relevant Offer Shares at the
final Offer Price, the Cornerstone Investors do not have any preferential rights in the
Cornerstone Investment Agreements compared with other public Shareholders. Other than the
Cornerstone Investment Agreements, as confirmed by each of the Cornerstone Investors, there
are no side agreements or arrangements between us and the Cornerstone Investors or any
benefit, direct or indirect, conferred on the Cornerstone Investors by virtue of or in relation to
the Listing, other than a guaranteed allocation of the relevant Offer Shares at the final Offer
Price.
The Cornerstone Investors have agreed to fully pay for the relevant Offer Shares that they
have subscribed before dealings in the Company’s Shares commence on the Stock Exchange.
Some of the Cornerstone Investors have agreed that our Company and the Sole Sponsor-
Overall Coordinator may in their sole discretion defer the delivery of all or part of the Offer
Shares it will subscribe to on a date later than the Listing Date. Such delayed delivery
arrangement is in place to facilitate the over-allocation in the International Offering. There will
be no delayed delivery if there is no over-allocation in the International Offering. Where
delayed delivery takes place, (i) there would be delayed delivery of Offer Shares to some of
the Cornerstone Investors based on commercial negotiations with the Cornerstone Investors,
(ii) the delayed delivery date should be no later than three business days following the last day
on which the Over-allotment Option may be exercised, (iii) no extra payment will be made to
the relevant Cornerstone Investors for the purpose of the delayed delivery arrangement, and
(iv) each of the Cornerstone Investors has agreed that it shall nevertheless fully pay for the
relevant Offer Shares in full before the Listing. As such, there will not be any deferred
settlement in payment by the Cornerstone Investors.
The number of Offer Shares to be subscribed by the Cornerstone Investors pursuant to the
Cornerstone Placing may be affected by reallocation of the Offer Shares between the
International Offering and the Hong Kong Public Offering as described in the section headed
“Structure of the Global Offering — The Hong Kong Public Offering — Reallocation” at the
discretion of the Sole Sponsor-Overall Coordinator. Details of the actual number of Offer
Shares to be allocated to the Cornerstone Investors will be disclosed in the Allotment Results
Announcement.
CORNERSTONE INVESTORS
– 485 –


--- page 495 ---
THE CORNERSTONE INVESTORS
The information about our Cornerstone Investors set forth below has been provided by
our Cornerstone Investors in connection with the Cornerstone Placing.
RTW Funds
RTW Master Fund, Ltd., RTW Innovation Master Fund, Ltd. and RTW Biotech
Opportunities Ltd
RTW Master Fund, Ltd. (“ RTW Master Fund ,” a private investment fund incorporated
in the Cayman Islands), RTW Innovation Master Fund, Ltd. (“ RTW Innovation Fund ,” a
private investment fund incorporated in the Cayman Islands) and RTW Biotech Opportunities
Ltd (“ RTW Biotech ,” a publicly listed investment fund incorporated in Guernsey, together
with RTW Master Fund and RTW Innovation Fund, the “ RTW Funds ”) are collective
investment vehicles consisting of hundreds of underlying investors that are high-net-worth
individuals, institutional investors, funds of funds, etc. As of June 30, 2025, RTW Master Fund,
RTW Innovation Fund and RTW Biotech had approximately US$2.9 billion, US$2.3 billion and
US$561 million in assets under management, respectively. As of June 30, 2025, RTW Master
Fund and RTW Innovation Fund had 1,440 and 349 limited partners, respectively, none of
whom owned more than a 30% partnership interest in the relevant fund. RTW Biotech is a fund
listed on the London Stock Exchange (ticker code: RTW).
RTW Funds are managed by RTW Investments, LP (“ RTW Investments ”), a healthcare
and biotech investment management firm based in New Y ork. The general partner of RTW
Investments is RTW Investments GP , LLC. Rod Wong, an Independent Third Party, is the sole
member of RTW Investments GP , LLC. RTW Investments is a full life cycle investment firm
supporting scientists and entrepreneurs at any stage where it identifies opportunity, from
academic programs in need of industry sponsorship all the way to mature publicly traded
companies.
TruMed
TruMed Healthcare Master Fund and TruMed Health Innovation Fund LP
TruMed Healthcare Master Fund (“ TruMed Healthcare ”), a limited liability company
incorporated in the Cayman Islands, is a healthcare focused pooled investment fund whose
investment manager is TruMed Investment Management Limited. TruMed Investment
Management Limited is controlled by Ms. Ting Wang. Save as Ms. Ting Wang who ultimately
beneficially owns more than 30% interest in TruMed Healthcare Master Fund and is an
Independent Third Party, none of the remaining investors hold more than 30% interest in
TruMed Healthcare Master Fund.
CORNERSTONE INVESTORS
– 486 –


--- page 496 ---
TruMed Health Innovation Fund LP (“ TruMed Innovation Fund ,” together with TruMed
Healthcare, “ TruMed ”) is a limited partnership incorporated in the Cayman Islands, and it is
a pooled investment fund primarily investing in healthcare equities. The general partner is
TruMed Health Innovation Fund GP Limited, which is controlled by Ms. Ting Wang. No other
party holds more than 30% shareholding interest in TruMed Health Innovation Fund GP
Limited. TruMed Health Innovation Fund LP has over 20 limited partners. None of the limited
partners holds 30% or more equity interest in TruMed Health Innovation Fund LP .
OrbiMed
OrbiMed Genesis Master Fund, L.P ., The Biotech Growth Trust PLC and OrbiMed Partners
Master Fund Limited
OrbiMed Genesis Master Fund, L.P . (“ Genesis ”) is an exempted limited partnership
incorporated in the Cayman Islands. OrbiMed Genesis GP LLC (“ Genesis GP ”) is the general
partner of Genesis. OrbiMed Advisors LLC (“ OrbiMed Advisors ”) is the managing member
of Genesis GP . OrbiMed Advisors exercises voting and investment power through a
management committee comprised of Carl L. Gordon, Sven H. Borho and W. Carter Neild,
each of whom disclaims beneficial ownership of the shares held by Genesis, except to the
extent of its or his pecuniary interest therein if any, and each of them is a third party
independent of the Company. No single limited partner of Genesis, directly or indirectly, owns
equal to or more than 30% of Genesis. Genesis invests primarily in innovative life sciences
companies engaged in the discovery and development of novel products and services that aim
to address significant unmet medical needs.
The Biotech Growth Trust PLC (“ BIOG ”) is a publicly listed trust listed on the London
Stock Exchange (stock ticker: BIOG) and organized in England and Wales. OrbiMed Capital
LLC (“ OrbiMed Capital ”) is the portfolio manager of BIOG. OrbiMed Capital exercises
voting and investment power through a management committee comprised of Carl L. Gordon,
Sven H. Borho and W. Carter Neild, each of whom disclaims beneficial ownership of the shares
held by BIOG, except to the extent of its or his pecuniary interest therein if any, and each of
them is a third party independent of the Company. No single limited partner of BIOG, directly
or indirectly, owns equal to or more than 30% of BIOG. BIOG invests in a diversified portfolio
of shares and related securities in biotechnology companies on a worldwide basis.
OrbiMed Partners Master Fund Limited (“ OPM”) is a Bermuda exempted company
limited by shares. OrbiMed Capital is the investment advisor of OPM. OrbiMed Capital
exercises voting and investment power through a management committee comprised of Carl L.
Gordon, Sven H. Borho and W. Carter Neild, each of whom disclaims beneficial ownership of
the shares held by OPM, except to the extent of its or his pecuniary interest therein if any, and
each of them is a third party independent of the Company. None of the shareholders of OPM,
directly or indirectly, owns equal to or more than 30% of OPM, except for one shareholder who
directly owns more than 30% of OPM, and such shareholder is a third party independent of the
Company. OPM invests in a diversified portfolio of shares and related securities in
biotechnology companies on a worldwide basis.
CORNERSTONE INVESTORS
– 487 –


--- page 497 ---
Genesis, BIOG and OPM are investment funds managed by OrbiMed Advisors or
OrbiMed Capital as applicable, and therefore their interests in cornerstone investments should
be aggregated.
UBS Asset Management (Singapore) Ltd.
UBS Asset Management (Singapore) Ltd. (“ UBS AM Singapore ”), a company
incorporated in Singapore in December 1993, has entered into a cornerstone investment
agreement with the Company, the Sole Sponsor and Sole Sponsor-OC, in its capacity as the
delegate of the investment manager for and on behalf of the following fund(s), which are
discretionary funds and there is no investor holding more than 30% of each of the funds: (i)
UBS (Lux) Equity Fund — Greater China (USD); (ii) UBS (Lux) Equity Fund — China
Opportunity (USD); (iii) UBS (HK) Fund Series — China Opportunity Equity (USD); (iv) UBS
(Lux) Equity SICA V — All China (USD); (v) UBS (Lux) Investment SICA V — China A
Opportunity (USD); (vi) UBS (CAY) China A Opportunity; and (vii) certain other segregated
accounts and mandates.
UBS AM Singapore is a wholly owned subsidiary of UBS Asset Management AG, an
investment management company, which is wholly ultimately owned by UBS Group AG,
which is a company organized under Swiss law as a corporation that has issued shares of
common stock to investors. UBS Group AG’s shares are listed on the SIX Swiss Exchange
(stock ticker: UBSG) and the New Y ork Stock Exchange (stock ticker: UBS).
Vivo Funds
Vivo Opportunity Fund Holdings, L.P . and Vivo Opportunity Cayman Fund, L.P . (together,
“Vivo Funds”)
Vivo Opportunity Fund Holdings, L.P . is a private fund organized under the laws of the
State of Delaware. It primarily invests in public companies in the healthcare and life sciences
sector. Vivo Opportunity, LLC (whose managing members are Kevin Dai, Gaurav Aggarwal,
Frank Kung and Shan Fu) is the general partner of Vivo Opportunity Fund Holdings, L.P .. No
single limited partner of Vivo Opportunity Fund Holdings, L.P . holds more than 30% of its
partnership interests. Vivo Opportunity Cayman Fund, L.P . is a private fund organized under
the laws of the Cayman Islands. It primarily invests in public companies in the healthcare and
life sciences sector. Vivo Opportunity Cayman, LLC (whose managing members are Kevin Dai,
Gaurav Aggarwal, Frank Kung and Shan Fu) is the general partner of Vivo Opportunity
Cayman Fund, L.P . Save and except for one limited partner who is an Independent Third Party
who holds more than 30% of the partnership interest, none of the other limited partners of Vivo
Opportunity Cayman Fund, L.P . holds more than 30% of its partnership interests.
Vivo Opportunity Fund Holdings, L.P . and Vivo Opportunity Cayman Fund, L.P . are
private funds managed by Vivo Capital, LLC (whose managing members are Frank Kung,
Edgar Engleman, Shan Fu, Gaurav Aggarwal and Michael Chang), and therefore their interests
in cornerstone investments should be aggregated.
CORNERSTONE INVESTORS
– 488 –


--- page 498 ---
CUAM Entities
China Universal Asset Management Company Limited and China Universal Asset
Management (Hong Kong) Company Limited
China Universal Asset Management Company Limited (ʮ̡)
(“CUAM ”) is a joint stock company established in the PRC with limited liability on February
3, 2005 and is principally engaged in the business of fund and asset management covering areas
such as mutual funds, segregated accounts, international business and pension funds. CUAM
possesses all the licenses required to engage in fund management business in the securities
industry in the PRC. As of the second quarter of 2025, CUAM managed 363 mutual funds,
covering equity funds, bond funds, index funds, QDII funds, mixed funds and money market
funds. CUAM is owned by Orient Securities Co., Ltd (ʮ̡)( “ OSC”),
Shanghai Jingjujin Investment Management Partnership (Limited Partnership) (ҳ
༟၍ଣΥྫΆุ(Υྫ)) (“ Shanghai Jingjujin ”), Shanghai United Media Asset
Management Co., Ltd (ʮ̡)( “ Shanghai United ”) and CES Finance
Holding Co., Ltd (ப΂ʮ̡)( “ CES”) as to 35.412%, 24.656%, 19.966% and
19.966%, respectively.
OSC is a public company dually listed on the Shanghai Stock Exchange (stock code:
600958) and the Hong Kong Stock Exchange (stock code: 3958) and is a professional and
integrated financial service provider. To the best of our Directors’ knowledge, information and
belief after making reasonable enquiries and as confirmed by OSC, it does not require any
approval from the Shanghai Stock Exchange or the Hong Kong Stock Exchange, nor its
shareholders, to indirectly invest in our Company. Shanghai Jingjujin is an employee
shareholding platform of CUAM. Shanghai Jingjujin is a limited partnership enterprise
established in the PRC and is principally engaged in the business of investment management.
The general partner of Shanghai Jingjujin is Shanghai Jingju Investment Management Co., Ltd.
(ʮ̡)( “ Jingju Investment Management ”) and none of the
shareholder of Jingju Investment Management holds more than 30% of its shareholding
interests. Shanghai Jingjujin has five limited partners, among which Shanghai Jingjumu
Investment Management Centre (Limited Partnership) ( ɪऎവၳ˝ҳ༟၍ଣʕː(Υྫ))
and Shanghai Jingjushui Investment Management Centre (Limited Partnership) ( ɪऎവၳ˥ҳ
༟၍ଣʕː(Υྫ)) holds 40.93% and 34.11% of the limited partnership interests of
Shanghai Jingjujin, respectively, and each of their general partner is Jingju Investment
Management. None of the other limited partners holds more than 30% of the partnership
interests of Shanghai Jingjujin. Shanghai United is a limited liability company established in
the PRC and is a professional investment platform focusing on the investment in property and
financial equity areas. Shanghai United is ultimately controlled by Shanghai State-owned
Assets Supervision and Administration Commission (ึ).
CORNERSTONE INVESTORS
– 489 –


--- page 499 ---
CES is a limited liability company established in the PRC and is an investment holding
vehicle of China Eastern Airline Holding Company (ʮ̡)( “CEAHC ”)
focusing on financial assets management and investment. CES is a wholly-owned subsidiary of
CEAHC, which is in turn ultimately controlled by State-owned Assets Supervision and
Administration Commission of the State Council of the PRC ( ʕശɛ͏΍ձ਷਷ਕ৫਷Ϟ༟ପ
ึ).
China Universal Asset Management (Hong Kong) Company Limited (“ China Universal
(HK) ,” together with CUAM, “ CUAM Entities ”), founded in November 2009, is a wholly
owned subsidiary of CUAM. China Universal (HK) is among the first group of Chinese fund
management company subsidiaries established outside of Mainland China. China Universal
(HK) is licensed by the Hong Kong Securities and Futures Commission to carry on Type 1
(Dealing in Securities), Type 4 (Advising on Securities) and Type 9 (Asset Management)
regulated activities under Part V of the Securities and Futures Ordinance. China Universal
(HK) manages investment funds, provides investment advisory services, and manages
discretionary accounts.
As confirmed by China Universal (HK), the subscription of the Offer Shares as a
cornerstone investor will be made by it in its capacity as the investment manager for and on
behalf of the following fund(s) and discretionary investment account(s): CUAM China-Hong
Kong Strategy Fund, Better Supply Chain (HK) Holdings Co., Limited.
The mission of China Universal (HK) is to be the gateway for oversea investments into
China as well as domestic investments going oversea. Leveraging its expertise in the local
market, it looks to build trusted partnerships with international investors who seek to invest
into China; building upon its overseas presence, China Universal (HK) also offer unique
international investment opportunities to domestic Chinese institutional and individual
investors.
Fullgoal Entities
Fullgoal Fund Management Co., Ltd. and Fullgoal Asset Management (HK) Limited
Fullgoal Fund Management Co., Ltd. (ʮ̡)( “ Fullgoal Fund ”) is a
fund management company established in China in April 1999, and is one of the first ten fund
management companies authorized by the CSRC and other regulatory authorities to obtain full
licenses to provide asset management services in the PRC. Fullgoal Fund has a registered
capital of RMB520 million and its main scope of business includes the provision of traditional
fund management services, fund raising, fund sale and asset management solutions to both
domestic and overseas clients. Fullgoal Fund is a QDII approved by the relevant PRC authority
and is also the first fund management company with foreign equity participation among the
first ten fund management companies in China. The relevant funds proposed to subscribe for
the Offer Shares under the management of Fullgoal Fund are open-ended publicly raised
securities investment funds registered with the CSRC.
CORNERSTONE INVESTORS
– 490 –


--- page 500 ---
The shareholders of Fullgoal Fund include (i) Guotai Haitong Securities Co., Ltd. ( ਷इ
ʮ̡) holding 27.775% in Fullgoal Fund; (ii) Shenwan Hongyuan Securities
Co., Ltd. (ʮ̡) holding 27.775% in Fullgoal Fund; (iii) Bank of Montreal
holding 27.775% in Fullgoal Fund, and (iv) Shandong Financial Asset Management Co., Ltd.
(ʮ̡), holding 16.675% in Fullgoal Fund.
Established in 2012 in Hong Kong, Fullgoal Asset Management (HK) Limited (“ Fullgoal
HK,” together with Fullgoal Fund, “ Fullgoal Entities ”) is a wholly owned subsidiary of
Fullgoal Fund. Fullgoal HK has Type 1 (Dealing in Securities), Type 4 (Advising on Securities)
and Type 9 (Asset Management) licenses issued by the SFC.
The Offer Shares to be allocated and issued to Fullgoal HK and Fullgoal Fund in their
capacity as investment managers acting as agents on behalf of certain clients, will be held on
a discretionary basis for and on behalf of clients who are Independent Third Parties to the best
knowledge of Fullgoal HK and Fullgoal Fund.
CITIC Securities International Capital Management Limited (in connection with Tibet
Longrising OTC Swaps)
CITIC Securities International Capital Management Limited (“ CSICM ”) and CITIC
Securities Company Limited (“ CITICS ”) will enter into a series of delta-one OTC swap
transactions (collectively, the “ Tibet Longrising OTC Swaps ”) with each other and the
ultimate clients (the “ CSICM Ultimate Clients (Tibet Longrising) ”), pursuant to which
CSICM will hold the Offer Shares on a non-discretionary basis to hedge the Tibet Longrising
OTC Swaps while the economic risks and returns of the underlying Offer Shares are ultimately
borne by the CSICM Ultimate Clients (Tibet Longrising), subject to customary fees and
commissions. The Tibet Longrising OTC Swaps will be fully funded by the CSICM Ultimate
Clients (Tibet Longrising). During the terms of the Tibet Longrising OTC Swaps, all economic
returns of the Offer Shares subscribed by CSICM will be ultimately enjoyed by the CSICM
Ultimate Clients (Tibet Longrising) and all economic loss shall be borne by the CSICM
Ultimate Clients (Tibet Longrising) according to the terms and conditions under the Tibet
Longrising OTC Swaps, and CSICM will not take part in any economic return or bear any
economic loss in relation to the Offer Shares. The Tibet Longrising OTC Swaps are linked to
the Offer Shares and the CSICM Ultimate Clients (Tibet Longrising) may, after expiration of
the lock-up period beginning from the date of the cornerstone agreement entered into between
CSICM and the Company and ending on the date which is six months from the Listing Date,
request to early terminate the Tibet Longrising OTC Swaps at their own discretion, upon which
CSICM may dispose of the Offer Shares and settle the Tibet Longrising OTC Swaps in cash
in accordance with the terms and conditions of the Tibet Longrising OTC Swaps. Despite that
CSICM will hold the legal title of the Offer Shares by itself, it wiIl not exercise the voting
rights attaching to the relevant Offer Shares during the terms of the Tibet Longrising OTC
Swaps according to its internal policy. To the best of CSICM’s knowledge having made all
reasonable inquiries, each of the CSICM Ultimate Clients (Tibet Longrising) is an independent
third party of CSICM, CITIC Securities (Hong Kong) Limited and the companies which are
members of the same group of CITIC Securities (Hong Kong) Limited and CLSA Limited.
CORNERSTONE INVESTORS
– 491 –


--- page 501 ---
Save for Zeng Xiaojie ( ಀወᆎ), a professional individual investor who owns approximately
39.04% in Longrising-Shengshi No. 8 Private Securities Investment Fund ( ๕ᆀ᳅— ᳅˰8໮ӷ
ږand approximately 98.19% in Longrising Qiangshu Private Securities
Investment Fund (ږLü Xiaojiu ( ѐʃɘ), a professional investor
who owns approximately 92.92% in Longrising Bimi Private Securities Investment Fund ( ๕
ږand Y ang Jianhai (ऎ), a professional investor who owns
approximately 96.16% in Longrising Xinyun Private Securities Investment Fund ( ๕ᆀ᳅อථ
ږeach a CSICM Ultimate Client (Tibet Longrising), there is no other single
ultimate beneficial owner holds 30% or more interests in each of the remaining eight CSICM
Ultimate Clients (Tibet Longrising).
CSICM is a wholly-owned subsidiary of CITICS, of which its shares are listed on the
Shanghai Stock Exchange (stock code: 600030) and the Hong Kong Stock Exchange (stock
code: 6030). CSICM is a connected client (as defined under Appendix F1 to the Listing Rules)
of CITIC Securities (Hong Kong) Limited and CLSA Limited, holding securities on a
non-discretionary basis on behalf of independent third parties. The Company has applied to the
Stock Exchange for, and the Stock Exchange has granted, its consent under paragraph 1C(1)
of Appendix F1 to the Listing Rules to permit us to allocate the Offer Shares to CSICM. See
“Waivers and Exemption – Consent in respect of Cornerstone Investment by Connected
Client.”
CSICM Ultimate Clients (Tibet Longrising) are twelve private funds managed by Tibet
Longrising Asset Management Co., Ltd. (ʮ̡)( “Tibet Longrising ”)
on a discretionary basis in its capacity as investment manager. Tibet Longrising is founded in
August 2013. With a registered capital of RMB10 million and the total asset under management
of approximately RMB24 billion, the company boasts a full-fledged team covering investment
research, risk management, and client services, equipped with exceptional research capabilities
and acute market analysis skills. Its portfolio comprises sectors such as pharmaceuticals,
electronics, construction, and consumer goods. Since 2013, Tibet Longrising has demonstrated
outstanding investment expertise in a complex and volatile economic environment. In 2015, it
focused on allocating high — growth stocks based on reform expectations and market liquidity
characteristics. When monetary policy tightened in 2017, it increased its holdings in consumer
and financial industries. In 2020, it made relevant investments in the internet industry when the
COVID-19 pandemic broke out. In 2021, during the first year of the carbon-peaking and
carbon-neutrality goals, it grasped high- growth assets such as photovoltaic and lithium-battery
industries. It can make relatively precise investment decisions under different economic
scenarios, fully reflecting the company’s rich investment experience. Tibet Longrising
continues to strengthen and improve its corporate governance, adhering to standardized risk
management as the foundation, pursuing absolute returns for investors, and taking the most
transparent supervision as a driving force. It is committed to becoming a leader in China’s local
private equity funds, providing professional wealth management services and investment
products that can sustainably create stable returns for high-net-worth individuals and high-end
financial institutions. Save for Zeng Xiaojie holding 61.75% equity interest in Tibet
Longrising, there is no other shareholder who owns 30% or more in Tibet Longrising.
CORNERSTONE INVESTORS
– 492 –


--- page 502 ---
As confirmed by our PRC Legal Advisors, based on the assumption that CSICM’s
domestic cooperating institutions have carried out sufficient risk disclosure and qualified
investor assessment procedures, this transaction structure is not explicitly prohibited by the
PRC law at present, though ongoing attention to evolving regulatory requirements remains
necessary.
Lake Bleu Entities
Lake Bleu Prime Healthcare Master Fund Limited, Lake Bleu Innovation Healthcare
Master Fund Limited and LBC HK Opportunity Fund Limited
Lake Bleu Prime Healthcare Master Fund Limited (“ Lake Bleu Prime ”) is a long-bias
fund that primarily invests in publicly traded equities across various sectors, including
healthcare, as well as other industries. Recently, Lake Bleu Prime acts as a cornerstone investor
for certain companies listed on the Hong Kong Stock Exchange, including Joinn Laboratories
(China) Co., Ltd. (stock code: 6127), Suzhou Basecare Medical Corporation Limited (stock
code: 2170), New Horizon Health Limited (stock code: 6606), JD Health International Inc.
(stock code: 6618), MicroPort CardioFlow Medtech Corporation (stock code: 2160), Akeso,
Inc. (stock code: 9926), Pharmaron Beijing Co., Ltd. (stock code: 3759), RemeGen Co., Ltd.
(stock code: 9995), Hygeia Healthcare Holdings Co., Limited (stock code: 6078), and Kangji
Medical Holdings Limited (stock code: 9997). Lake Bleu Prime is dedicated to assisting its
portfolio companies with value-added initiatives and has successfully supported numerous
companies in achieving this goal. Lake Bleu Capital is also licensed by the SFC to carry out
type 9 regulated activities.
Lake Bleu Innovation Healthcare Master Fund Limited (“ Lake Bleu Innovation ”) is a
long-bias fund that primarily invests in publicly traded equities across various sectors,
including healthcare, as well as other industries. Lake Bleu Innovation is dedicated to assisting
its portfolio companies with value-added initiatives and has successfully supported numerous
companies in achieving this goal.
LBC HK Opportunity Fund Limited (“ LBC HK Opportunity ,” together with Lake Bleu
Prime and Lake Bleu Innovation, “ Lake Bleu Entities ”) is a long-bias fund that primarily
invests in publicly traded equities across various sectors, including healthcare, as well as other
industries in Hong Kong market.
Each of Lake Bleu Prime, Lake Bleu Innovation and LBC HK Opportunity is managed by
Lake Bleu Capital (Hong Kong) Limited (“ Lake Bleu Capital ”). Bin LI, an Independent Third
Party, is the ultimate beneficial owner of Lake Bleu Capital. To the best of the knowledge,
information and belief of our Company, Lake Bleu Prime, Lake Bleu Innovation and LBC HK
Opportunity, together with their ultimate beneficial owners, are Independent Third Parties.
CORNERSTONE INVESTORS
– 493 –


--- page 503 ---
Set out below is the details of the Cornerstone Placing:
Cornerstone Investor
Investment
amount
(US$) (1)
Number of
Offer
Shares (2)
Assuming the Offer Size Adjustment Option
is not exercised
Assuming the Offer Size Adjustment Option
is fully exercised
Assuming the
Over-allotment Option
is not exercised
Assuming the
Over-allotment Option
is fully exercised
Assuming the
Over-allotment Option
is not exercised
Assuming the
Over-allotment Option
is fully exercised
Approximate
%o ft h e
Offer Shares
Approximate
%o fo u r
total issued
share capital
Approximate
%o ft h e
Offer Shares
Approximate
%o fo u r
total issued
share capital
Approximate
%o ft h e
Offer Shares
Approximate
% of our
total issued
share capital
Approximate
% of the
Offer Shares
Approximate
%o fo u r
total issued
share capital
RTW Funds /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815,000,000 5,735,200 7.39% 1.66% 6.43% 1.61% 6.43% 1.61% 5.59% 1.55%
– RTW Master Fund, Ltd. /H1118/H1118/H1118/H1118/H1118/H11187,987,873 3,054,200 3.94% 0.88% 3.42% 0.86% 3.42% 0.86% 2.98% 0.82%
– RTW Innovation Master Fund,
Ltd. /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,393,087 2,444,400 3.15% 0.71% 2.74% 0.68% 2.74% 0.68% 2.38% 0.66%
– RTW Biotech Opportunities Ltd /H1118 619,040 236,600 0.30% 0.07% 0.27% 0.07% 0.27% 0.07% 0.23% 0.06%
TruMed /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111812,500,000 4,779,200 6.16% 1.38% 5.36% 1.34% 5.36% 1.34% 4.66% 1.29%
– TruMed Health Innovation Fund
LP /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111811,500,000 4,397,000 5.67% 1.27% 4.93% 1.23% 4.93% 1.23% 4.28% 1.19%
– TruMed Healthcare Master Fund /H1118 1,000,000 382,200 0.49% 0.11% 0.43% 0.11% 0.43% 0.11% 0.37% 0.10%
OrbiMed /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111812,500,000 4,779,200 6.16% 1.38% 5.36% 1.34% 5.36% 1.34% 4.66% 1.29%
– OrbiMed Genesis Master Fund,
L.P ./H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,977,193 1,903,000 2.45% 0.55% 2.13% 0.53% 2.13% 0.53% 1.85% 0.51%
– OrbiMed Partners Master Fund
Limited /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,602,413 1,759,600 2.27% 0.49% 1.97% 0.49% 1.97% 0.49% 1.71% 0.48%
– The Biotech Growth Trust PLC /H1118/H11182,920,394 1,116,600 1.44% 0.32% 1.25% 0.31% 1.25% 0.31% 1.09% 0.30%
CORNERSTONE INVESTORS
– 494 –


--- page 504 ---
Cornerstone Investor
Investment
amount
(US$) (1)
Number of
Offer
Shares (2)
Assuming the Offer Size Adjustment Option
is not exercised
Assuming the Offer Size Adjustment Option
is fully exercised
Assuming the
Over-allotment Option
is not exercised
Assuming the
Over-allotment Option
is fully exercised
Assuming the
Over-allotment Option
is not exercised
Assuming the
Over-allotment Option
is fully exercised
Approximate
%o ft h e
Offer Shares
Approximate
%o fo u r
total issued
share capital
Approximate
%o ft h e
Offer Shares
Approximate
%o fo u r
total issued
share capital
Approximate
%o ft h e
Offer Shares
Approximate
% of our
total issued
share capital
Approximate
% of the
Offer Shares
Approximate
%o fo u r
total issued
share capital
UBS Asset Management (Singapore)
Ltd. /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111810,000,000 3,823,400 4.93% 1.11% 4.28% 1.07% 4.28% 1.07% 3.73% 1.03%
Vivo Funds /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111810,000,000 3,823,400 4.93% 1.11% 4.28% 1.07% 4.28% 1.07% 3.73% 1.03%
– Vivo Opportunity Fund Holdings,
L.P ./H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11189,082,574 3,472,800 4.48% 1.01% 3.89% 0.97% 3.89% 0.97% 3.38% 0.94%
– Vivo Opportunity Cayman Fund,
L.P ./H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118917,426 350,600 0.45% 0.10% 0.39% 0.10% 0.39% 0.10% 0.34% 0.09%
CUAM Entities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111810,000,000 3,823,400 4.93% 1.11% 4.28% 1.07% 4.28% 1.07% 3.73% 1.03%
– China Universal Asset
Management (Hong Kong)
Company Limited /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,000,000 3,058,800 3.94% 0.89% 3.43% 0.86% 3.43% 0.86% 2.98% 0.83%
– China Universal Asset
Management Company Limited /H1118/H11182,000,000 764,600 0.99% 0.22% 0.86% 0.21% 0.86% 0.21% 0.75% 0.21%
Fullgoal Entities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111810,000,000 3,823,400 4.93% 1.11% 4.28% 1.07% 4.28% 1.07% 3.73% 1.03%
– Fullgoal Fund Management Co.,
Ltd. /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,000,000 3,058,800 3.94% 0.89% 3.43% 0.86% 3.43% 0.86% 2.98% 0.83%
– Fullgoal Asset Management (HK)
Limited /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,000,000 764,600 0.99% 0.22% 0.86% 0.21% 0.86% 0.21% 0.75% 0.21%
CORNERSTONE INVESTORS
– 495 –


--- page 505 ---
Cornerstone Investor
Investment
amount
(US$) (1)
Number of
Offer
Shares (2)
Assuming the Offer Size Adjustment Option
is not exercised
Assuming the Offer Size Adjustment Option
is fully exercised
Assuming the
Over-allotment Option
is not exercised
Assuming the
Over-allotment Option
is fully exercised
Assuming the
Over-allotment Option
is not exercised
Assuming the
Over-allotment Option
is fully exercised
Approximate
%o ft h e
Offer Shares
Approximate
%o fo u r
total issued
share capital
Approximate
%o ft h e
Offer Shares
Approximate
%o fo u r
total issued
share capital
Approximate
%o ft h e
Offer Shares
Approximate
% of our
total issued
share capital
Approximate
% of the
Offer Shares
Approximate
%o fo u r
total issued
share capital
CITIC Securities International
Capital Management Limited /H1118/H1118/H111810,000,000 3,823,400 4.93% 1.11% 4.28% 1.07% 4.28% 1.07% 3.73% 1.03%
Lake Bleu Entities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111810,000,000 3,823,400 4.93% 1.11% 4.28% 1.07% 4.28% 1.07% 3.73% 1.03%
– LBC HK Opportunity Fund
Limited /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,010,000 1,533,200 1.98% 0.44% 1.72% 0.43% 1.72% 0.43% 1.49% 0.41%
– Lake Bleu Prime Healthcare
Master Fund Limited /H1118/H1118/H1118/H1118/H1118/H1118/H11183,830,000 1,464,400 1.89% 0.42% 1.64% 0.41% 1.64% 0.41% 1.43% 0.40%
– Lake Bleu Innovation Healthcare
Master Fund Limited /H1118/H1118/H1118/H1118/H1118/H1118/H11182,160,000 825,800 1.06% 0.24% 0.93% 0.23% 0.93% 0.23% 0.80% 0.22%
TOTAL /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,000,000 38,234,000 49.27% 11.07% 42.84% 10.71% 42.84% 10.71% 37.26% 10.32%
Notes:
(1) The investment amount excludes brokerage, SFC transaction levy, AFRC transaction levy and Stock Exchange trading fee, and to be converted to Hong Kong dollars based on
the exchange rate as disclosed in the section headed “Information about this Prospectus and the Global Offering — Currency Translations” in this Pros pectus.
(2) Rounded down to the nearest whole board lot of 200 H Shares, and is calculated based on the exchange rate set out in the section headed “Information ab out this Prospectus
and the Global Offering — Currency Translations” in this Prospectus.
CORNERSTONE INVESTORS
– 496 –


--- page 506 ---
CLOSING CONDITIONS
The obligation of each of the Cornerstone Investors to subscribe for the Offer Shares
under their respective Cornerstone Investment Agreement is subject to, among other things, the
following closing conditions:
(i) the Hong Kong Underwriting Agreement and the International Underwriting
Agreement being entered into and having become effective and unconditional (in
accordance with their respective original terms or as subsequently waived or varied
by agreement of the parties thereto) by no later than the time and date as specified
in the Hong Kong Underwriting Agreement and the International Underwriting
Agreement, and neither the Hong Kong Underwriting Agreement nor the
International Underwriting Agreement having been terminated;
(ii) the Offer Price having been agreed upon between our Company and the Sole
Sponsor-Overall Coordinator (for itself and on behalf of the Overall Coordinators
and the underwriters of the Global Offering);
(iii) the Listing Committee having granted the approval for the listing of, and permission
to deal in, the H Shares (including the H Shares under the Cornerstone Placing as
well as other applicable waivers and approvals) and such approval, permission or
waiver having not been revoked prior to the commencement of dealings in the H
Shares on the Stock Exchange;
(iv) no laws having been enacted or promulgated by any governmental authority which
prohibits the consummation of the transactions contemplated in the Global Offering
or each Cornerstone Investment Agreement, and there being no orders or injunctions
from a court of competent jurisdiction in effect precluding or prohibiting
consummation of such transactions; and
(v) the respective representations, warranties, undertakings, acknowledgements and
confirmations of the Cornerstone Investors under their respective Cornerstone
Investment Agreement are and will be accurate, true and complete in all respects and
not misleading or deceptive and that there is no breach of the respective Cornerstone
Investment Agreement on the part of the relevant Cornerstone Investor.
RESTRICTIONS ON THE CORNERSTONE INVESTORS
Each Cornerstone Investor has agreed that without the prior written consent of our
Company, the Sole Sponsor and the Overall Coordinators, it will not, whether directly or
indirectly, at any time during the period of six months following the Listing Date (the
“Lock-up Period ”), dispose of, in any way, any of the Offer Shares it has purchased, pursuant
to their respective Cornerstone Investment Agreement, save for certain limited circumstances,
such as transfers to any of its wholly-owned subsidiaries who will be bound by the same
obligations of the relevant Cornerstone Investor, including the Lock-up Period restriction.
CORNERSTONE INVESTORS
– 497 –


--- page 507 ---
This section presents certain information regarding our share capital before and upon
completion of the Global Offering.
BEFORE THE COMPLETION OF THE GLOBAL OFFERING
As of the Latest Practicable Date, the issued share capital of our Company was
RMB26,774,063, comprising 26,774,063 Unlisted Shares of nominal value RMB1.00 each.
UPON THE COMPLETION OF THE SHARE SUBDIVISION AND THE GLOBAL
OFFERING
Assuming the Offer Size Adjustment Option and the Over-allotment Option are not
exercised, the share capital of our Company immediately following completion of the Global
Offering (taking into account the Share Subdivision) will be as follows:
Description of Shares Number of Shares
Approximate
percentage of the
total share capital
of our Company
Unlisted Shares in issue /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111832,337,610 9.36%
H Shares to be converted from Unlisted Shares /H1118/H1118/H1118235,403,020 68.17%
H Shares to be issued under the Global Offering /H1118/H1118 77,600,000 22.47%
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118345,340,630 100.00%
Assuming the Offer Size Adjustment Option and the Over-allotment Option are fully
exercised, the share capital of our Company immediately following completion of the Global
Offering (taking into account the Share Subdivision), will be as follows:
Description of Shares Number of Shares
Approximate
percentage of the
total share capital
of our Company
Unlisted Shares in issue /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111832,337,610 8.73%
H Shares to be converted from Unlisted Shares /H1118/H1118/H1118235,403,020 63.56%
H Shares to be issued under the Global Offering /H1118/H1118102,626,000 27.71%
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118370,366,630 100.00%
SHARE CAPITAL
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RANKING
Upon completion of the Global Offering and the conversion of the Unlisted Shares into
H Shares, the Shares will consist of H Shares and Unlisted Shares. Upon completion of the
Global Offering, we would have only one class of Shares. H Shares and Unlisted Shares are
all ordinary Shares in the share capital of our Company. However, apart from certain qualified
domestic institutional investors in the PRC, the qualified PRC investors under the Shanghai —
Hong Kong Stock Connect or the Shenzhen — Hong Kong Stock Connect and other persons
who are entitled to hold our H Shares pursuant to relevant PRC laws and regulations or upon
approvals of any competent authorities, H Shares generally cannot be subscribed for by or
traded between legal or natural persons of the PRC.
Unlisted Shares and H Shares will rank pari passu with each other in all respects and, in
particular, will rank equally for all dividends or distributions declared, paid or made after the
date of this Prospectus. All dividends in respect of the H Shares are to be paid by us in Hong
Kong dollars or in the form of H Shares.
CONVERSION OF OUR UNLISTED SHARES INTO H SHARES
According to the regulations issued by the CSRC, the holders of our Unlisted Shares may,
at their own option, authorize the Company to apply to the CSRC for conversion of their
respective Unlisted Shares to H Shares, and such converted Shares may be listed and traded on
an overseas stock exchange provided that the required filings with the securities regulatory
authorities of the State Council for the conversion, listing and trading of such converted Shares
have been completed. Additionally, such conversion, trading and listing shall meet any
requirement of internal approval process and in all respects comply with the regulations
prescribed by the securities regulatory authorities of the State Council and the regulations,
requirements and procedures prescribed by the relevant overseas stock exchange. Save as
disclosed in this Prospectus and to the best knowledge of our Directors, we are not aware of
the intention of such existing Shareholders to convert their Unlisted Shares.
If any of the Unlisted Shares are to be converted, listed and traded as H Shares on the
Stock Exchange, the filings and approvals with the relevant PRC regulatory authorities,
including the CSRC, and the approval of the Stock Exchange are necessary for such
conversion. Based on the procedures for the conversion of Unlisted Shares into H Shares as set
forth below, we will apply for the listing of all or any portion of the Unlisted Shares on the
Stock Exchange as H Shares in advance of any proposed conversion after the Global Offering
to ensure that the conversion process can be completed promptly upon notice to the Stock
Exchange and delivery of Shares for entry on the H Share register. As the listing of additional
Shares after the Listing on the Stock Exchange is ordinarily considered by the Stock Exchange
to be a purely administrative matter, it does not require such prior application for listing at the
time of our Listing in Hong Kong. No class Shareholder voting is required for the conversion
of such Shares or the listing and trading of such converted Shares on an overseas stock
exchange. Any application for listing of the converted shares on the Stock Exchange after our
initial Listing is subject to prior notification by way of announcement to inform our
Shareholders and the public of any proposed conversion.
SHARE CAPITAL
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After all the requisite filings have been completed and approvals have been obtained, the
relevant Unlisted Shares will be withdrawn from the Unlisted Share register, and our Company
will re-register such Shares on the H Share register maintained in Hong Kong and instruct the
H Share Registrar to issue H Share certificates. Registration on the H Share register of our
Company will be on the conditions that (i) the H Share Registrar lodges with the Stock
Exchange a letter confirming the entry of the relevant H Shares on the H Share register and the
due dispatch of H Share certificates; and (ii) the admission of the H Shares to be traded on the
Stock Exchange complies with the Listing Rules and the General Rules of HKSCC and the
HKSCC Operational Procedures in force from time to time. Until the converted Shares are
re-registered on the H Share register of our Company, such Shares would not be listed as H
Shares.
TRANSFER OF SHARES ISSUED PRIOR TO THE GLOBAL OFFERING
Pursuant to the PRC Company Law, our Shares issued prior to the Listing shall not be
transferred within one year from the Listing Date.
Shares transferred by our Directors, Supervisors and members of the senior management
each year during their term of office shall not exceed 25% of their total respective
shareholdings in our Company unless otherwise permitted by applicable laws and regulations.
The Shares that the aforementioned persons hold in our Company cannot be transferred within
half a year after they leave their positions as Directors, Supervisors and members of the senior
management in our Company.
PRE-IPO EQUITY INCENTIVE SCHEME
We adopted the Pre-IPO Equity Incentive Scheme in 2020 as amended and restated in July
2023 and established the ESOP Platforms. All awards granted under the Pre-IPO Equity
Incentive Scheme had been vested and exercised and no further awards will be granted under
the Pre-IPO Equity Incentive Scheme upon Listing.
SHAREHOLDERS’ GENERAL MEETING
See “Appendix III — Summary of Articles of Association” for details of circumstances
under which our general meeting is required.
SHARE CAPITAL
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--- page 510 ---
You should read the following discussion and analysis with our consolidated
financial information, including the notes thereto, included in the Accountants’ Report in
Appendix I to this Prospectus. Our consolidated financial information has been prepared
in accordance with International Financial Reporting Standards issued by the
International Accounting Standards Board, which may differ in material aspects from
generally accepted accounting principles in other jurisdictions, including the United
States. You should read the entire Accountants’ Report and not merely rely on the
information contained in this section.
The following discussion and analysis contain forward-looking statements that
reflect our current views with respect to future events and financial performance. These
statements are based on our assumptions and analysis in light of our experience and
perception of historical trends, current conditions and expected future developments, as
well as other factors we believe are appropriate under the circumstances. However ,
whether actual outcomes and developments will meet our expectations and predictions
depends on a number of risks and uncertainties. In evaluating our business, you should
carefully consider the information provided in the section headed “Risk Factors” and
“Business” in this Prospectus.
For the purpose of this section, unless the context otherwise requires, references to
the year of 2023 and 2024 refer to our financial year ended December 31 of such year .
Unless the context otherwise requires, financial information described in this section is
described on a consolidated basis. Discrepancies between totals and sums of amounts
listed in this section in any table or elsewhere in this document may be due to rounding.
OVERVIEW
We are a biopharmaceutical company featuring a global vision, international
collaborations and operations. We adhere to an innovative development strategy, with a vision
to propel ourselves with the advancement of science and technology to build a globally
competitive biopharmaceutical company.
As of the Latest Practicable Date, we had established a product pipeline consisting of
eight product candidates, with five under clinical development. A substantial part of our
pipeline programs revolves around therapies targeting RAS family members, which are key
regulators during cellular signaling transduction to stimulate or silence downstream proteins to
effectuate regulation on cell growth, differentiation and survival. In particular, one of our Core
Products, GFH925 (fulzerasib, marketed under the brand name Dupert
®), has been approved
for commercialization in China for the treatment of advanced NSCLC. In addition to RAS, we
also explore treatment options for autoimmune and inflammatory diseases, including our
product candidate GFH312, and other cancer-related therapies. We believe that this diverse
range of pipeline products reflects our commitment to innovation and addressing various
medical needs through advanced therapeutic approaches.
FINANCIAL INFORMATION
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--- page 511 ---
During the Track Record Period, we realized revenues from licenses of intellectual
property and provision of research and development services. The revenues amounted to
RMB73.7 million, RMB104.7 million and RMB82.1 million for the year ended December 31,
2023 and 2024 and four months ended April 30, 2025, respectively. We did not realize revenue
for the four months ended April 30, 2024. Other than our Core Product, GFH925, which
received NDA approval from the NMPA in August 2024, our other drug candidates and
GFH925 in jurisdictions beyond China had not been approved for commercialization and had
not generated any revenue from product sales. We had not been profitable and had incurred
operating losses during the Track Record Period. For the years ended December 31, 2023 and
2024 and four months ended April 30, 2024 and 2025, we had total loss for the year/period of
RMB508.3 million and RMB677.6 million, RMB404.7 million and RMB66.6 million,
respectively. Our total loss for the year/period mainly resulted from research and development
costs and change in fair value of redemption liabilities on equity shares.
As GFH925 has been approved for commercialization in China, we anticipate to realize
revenues from sales of GFH925 pursuant to our agreement with Innovent. For additional
licensing information about the agreement, see “Business — Major Collaboration and
Licensing Arrangements.” However, we also anticipate incurring an increased amount of
research and development costs and operating expenses for the next several years as we
continue to advance our pipeline products in China and overseas. Subsequent to the Listing, we
expect to incur costs associated with operating as a public company. We expect that our
financial performance will fluctuate from period to period due to the development status of our
pipeline products, timeline and terms of potential collaboration with our partners, regulatory
approval timeline and commercialization of our drug candidates after approval.
BASIS OF PRESENTATION AND PREPARATION
Our consolidated financial information has been prepared in accordance with
International Financial Reporting Standards (“ IFRSs ”) (which include all IFRSs, International
Accounting Standards (“ IASs ”) and Interpretations) issued by the International Accounting
Standards Board (the “ IASB ”), and accounting principles generally accepted in Hong Kong.
All IFRSs effective for the accounting period commencing from January 1, 2025, together with
the relevant transitional provisions, have been adopted by us in the preparation of the
consolidated financial information for the Track Record Period.
The consolidated financial information has been prepared under the historical cost
convention, except for redemption liabilities on equity shares and wealth management products
that have been measured at fair value, as explained in the respective accounting policies in the
Accountants’ Report in Appendix I to this Prospectus. Our consolidated financial information
is presented in RMB and all values are rounded to the nearest thousand except when otherwise
indicated. The preparation of the consolidated financial information in conformity with IFRSs
requires the use of certain critical accounting estimates. It also requires our management to
exercise its judgment in the process of applying our accounting policies.
FINANCIAL INFORMATION
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--- page 512 ---
The Directors further assessed whether we have sufficient working capital to meet our
present obligations, taking into account the financial resources available to us. We have
prudently prepared a full-speed budget based for clinical trials of our Core Products and other
pipelines for 2025 assuming we are able to raise proceeds from the Listing as well as a
backbone budget plan to advance all necessary R&D activities for our Core Products assuming
we are unable to raise proceeds from the Listing. Based on the rigorous review of the budget
under either full-speed or backbone scenario, the Directors are satisfied that we would have
sufficient working capital to meet our present obligations, taking into account the financial
resources available to us for next twelve months from 30 April 2025.
Based on the above factors, our historical performance and our management’s operating
and financing plans, the Directors concluded that it is appropriate to prepare the consolidated
financial information for the Track Record Period on a going concern basis.
SIGNIFICANT FACTORS AFFECTING OUR RESULTS OF OPERATIONS
Our results of operations and financial condition have been, and are expected to continue
to be, principally affected by a number of factors, many of which may be beyond our control.
A discussion of the key factors is set out below.
Development and Commercialization of Our Pipeline Products
Our business and results of operations depend on our ability to successfully develop, as
well as our receipt of regulatory approval for and successful commercialization of, our drug
candidates. For pipeline products that we out license certain rights, including
commercialization rights, in certain jurisdictions to collaborators, our results of operations will
likely depend on the collaborators’ promotional and marketing efforts once those products are
approved in the relevant jurisdictions. As of the Latest Practicable Date, we had established a
diverse and innovative pipeline featuring eight pipeline products. A substantial part of our
pipeline programs revolves around therapies targeting RAS family members, which are key
regulators during cellular signaling transduction to stimulate or silence downstream proteins to
effectuate regulation on cell growth, differentiation and survival. For more information on the
development status of our Core Products and other drug candidates, see “Business — Our
Product Pipeline.” Our business and results of operations depend on our drug candidates
demonstrating favorable safety and efficacy profiles in clinical trials and our or our
collaborators’ ability to obtain the requisite regulatory approvals for the drug candidates.
While GFH925 has received NDA approval from the NMPA, which we expect to bring us
revenue from drug sales, GFH375 and other pipeline products have not been approved for
commercial sale, and we had not generated any revenue from product sales during the Track
Record Period. We expect to incur significant research and development costs and further
advance the pipeline products to the commercialization stage over the coming years. However,
our ability to generate revenue from our pipeline products to cover research and developments
costs and other expenses will depend on multiple factors, including but not limited to our
ability to obtain regulatory approvals, secure adequate manufacturing capacity, collaboration
with competent third-party partners, as well as making our products accessible to, affordable
for and accepted by the addressable patient population who are in need of high-quality products
that bring comprehensive benefits for oncology and immunology diseases.
FINANCIAL INFORMATION
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--- page 513 ---
Our Existing and Future Collaboration and Licensing Arrangements
In the past, we entered into a number of collaboration and licensing arrangements with
respect to our pipeline products, including our Core Products GFH925 and GFH375. We
generated revenue in the amount of RMB73.7 million, RMB104.7 million and RMB82.1
million in 2023, 2024 and April 30, 2025, respectively. Most of the revenue that we recognized
during the Track Record Period was generated from licenses of intellectual property under such
collaboration and out-licensing arrangements. We are eligible to receive further payments upon
the achievement of specified development, regulatory and commercial milestones, subject to
terms and conditions of these agreements. For additional information about the relevant
agreements, see “Business — Major Collaboration and Licensing Arrangements.” These
strategic collaborations empower us to maximize the global value of our assets and provide
capital support for our other pipeline assets and sustainable long-term growth. We may also
enter into new collaboration and licensing arrangements to serve our best interests. We
anticipate our existing and future collaboration and licensing arrangements to contribute a
substantial part of our revenue and cash inflows going forward, and payments associated with
such arrangements may influence and result in fluctuations in our revenue, profit and results
of operations from period to period.
Our Cost Structure
Our results of operations are significantly affected by our cost structure, of which our
research and development costs and administrative expenses are a major component.
We believe our ability to successfully develop drug candidates is the primary factor
affecting our long-term competitiveness, as well as our future growth and development.
Developing quality drug candidates requires significant investments of financial resources over
a prolonged period of time, and a core part of our strategy is to continue making sustained
investments in this area. As a result of this commitment, we have invested a significant amount
of financial resources in research and development to advance and expand our pipeline of
clinical- and preclinical-stage drug candidates. The research and development costs we
incurred for the years ended December 31, 2023 and 2024 and the four months ended April 30,
2024 and 2025 amounted to RMB312.7 million, RMB332.1 million, RMB142.3 million and
RMB69.8 million, respectively. See “— Description of Selected Components of Consolidated
Statements of Profit or Loss and Other Comprehensive Income — Research and Development
Costs” for detailed information.
We expect our research and development costs to continue to be a major component in our
cost structure. As we expand the indications and explore combination therapies of our Core
Products, advance more drug candidates along clinical trials and conduct additional preclinical
studies, we expect to incur additional costs in relation to, among other things, preclinical study
and clinical trial expenses, CMC expenses, raw materials procurements, manufacturing and
sales and marketing.
FINANCIAL INFORMATION
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--- page 514 ---
Our administrative expenses, which primarily consisted of staff costs and professional
services expenses, among others, amounted to RMB49.9 million, RMB58.1 million, RMB13.9
million and RMB23.7 million for the years ended December 31, 2023 and 2024 and the four
months ended April 30, 2024 and 2025, respectively. Our administrative expenses increased
during the Track Record Period mainly due to the increase in listing expense. We expect our
administrative expenses to increase in coming years to support our growing operations,
expanding product development efforts and entry into future collaboration and licensing
arrangements.
The change in fair value of redemption liabilities on equity shares also had a significant
impact on our financial position during the Track Record Period. We have recognized the
equity shares that we issued in the several rounds of investments that we historically received
as redemption liabilities on equity shares. Upon Listing, we do not expect to recognize any
further change in fair value of redemption liabilities on equity shares, as the redemption right
will be automatically terminated upon Listing, which we anticipate to allow us to turn into a
net assets, rather than net liabilities, position.
We expect our cost structure to evolve as we continue to develop and expand our business.
Beyond research and development costs and administrative expenses, we anticipate increasing
legal, compliance, accounting, insurance and investor and public relations expenses associated
with being a public company in Hong Kong.
Funding for Our Operations
During the Track Record Period, we funded our operations primarily through equity
financing. Going forward, in the event of the successful commercialization of one or more of
our pipeline products, we expect to primarily fund our operations with revenue generated from
sales of the commercialized drug products. However, with the continuing expansion of our
business, we may require further funding through public or private offerings, debt financing,
collaboration and licensing arrangements or other sources. Any fluctuation in the funding for
our operations will impact our cash flow and our results of operations.
MATERIAL ACCOUNTING POLICIES AND SIGNIFICANT ACCOUNTING
JUDGMENTS AND ESTIMATES
Our discussion and analysis of our financial condition and results of operations is based
on our financial statements, which have been prepared in accordance with accounting
principles that conform with IFRSs. The preparation of these financial statements requires us
to make estimates, assumptions and judgments that affect the reported amounts of assets,
liabilities, revenues, costs and expenses. We evaluate our estimates and judgments on an
ongoing basis, and our actual results may differ from these estimates. We base our estimates
on historical experience, known trends and events, contractual milestones and other various
factors that are believed to be reasonable under the circumstances, the results of which form
the basis for making judgments about the carrying values of assets and liabilities that are not
readily apparent from other sources.
FINANCIAL INFORMATION
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--- page 515 ---
We set forth below those accounting policies that we believe are of critical importance to
us or involve the most significant estimates and judgments used in the preparation of our
consolidated financial statements. Our material accounting policies and estimates, which are
important for an understanding of our financial condition and results of operations, are set forth
in detail in Notes 2 and 3 to the Accountants’ Report in Appendix I to this Prospectus.
Revenue Recognition
Revenue from contracts with customers
Revenue from contracts with customers is recognized when control of the goods or
services is transferred to the customer at an amount that reflects the consideration to which our
Group expects to be entitled in exchange for those goods or services.
When the consideration in a contract includes a variable amount, the amount of
consideration is estimated to which the Group will be entitled in exchange for transferring the
goods or services to the customer. The variable consideration is estimated at contract inception
and constrained until it is highly probable that a significant revenue reversal in the amount of
cumulative revenue recognized will not occur when the associated uncertainty with the variable
consideration is subsequently resolved.
Our revenue is generated from the collaboration agreements with Innovent and SELLAS,
which generally contain multiple performance obligations including (1) grants of licenses to
intellectual property rights and (2) the research and development services.
Collaboration revenue
At contract inception, we analyze the collaboration arrangements to assess whether they
are within the scope of IFRS 11 Joint Arrangements to determine whether such arrangements
involve joint operating activities performed by parties that are both active participants in the
activities and are exposed to significant risks and rewards dependent on the commercial
success of such activities.
In determining the appropriate amount of revenue to be recognized as we fulfill our
obligations under each of the collaboration agreements, our management performs the five-step
model under IFRS 15. The collaboration arrangements may contain more than one unit of
account or performance obligation, including grants of licenses to intellectual property rights
(the “ Licenses ”), agreements to provide research and development services and other
deliverables. The collaborative arrangements typically do not include a right of return for any
deliverable. In general, the consideration allocated to each performance obligation is
recognized when the obligation is satisfied either by delivering a good or rendering a service,
limited to the consideration that is not constrained. Non-refundable payments received before
all of the relevant criteria for revenue recognition are satisfied are recorded as contract
liabilities.
FINANCIAL INFORMATION
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--- page 516 ---
(a) Licenses of intellectual property
Upfront non-refundable payments for Licenses are evaluated to determine if they are
distinct from the other performance obligations identified in the arrangements. For the
Licenses determined to be distinct, we recognize revenues from non-refundable up-front fees
allocated to the licenses at a point in time, when the Licenses are transferred to the licensee
and the licensee is able to use and benefit from the Licenses.
Milestone payments
At the inception of each arrangement that includes development milestone payments
and commercial milestone payments, our management evaluates whether the milestones
are considered probable of being reached and estimates the amount to be included in the
transaction price using the most likely amount method. If it is probable that a significant
revenue reversal would not occur, the associated milestone value is included in the
transaction price. Milestones related to development-based activities may include
initiation of various phases of clinical trials. Due to the uncertainty involved in meeting
these development-based targets, they are generally fully constrained at contract
inception. Our management assesses whether the variable consideration is fully
constrained for each reporting period based on the facts and circumstances surrounding
the clinical trials. Upon changes to constraint associated with the developmental
milestones, variable consideration is included in the transaction price when a significant
reversal of revenue recognized is not expected to occur and allocated to the separate
performance obligations. Due to the inherent uncertainty with the approval process,
regulatory milestones are fully constrained until the period in which those regulatory
approvals are achieved. Regulatory milestones are included in the transaction price in the
period regulatory approval is obtained.
Royalties
For arrangements that include sales-based royalties, we recognize revenue when the
related sales occur.
(b) Research and development services
We provide our customer with a project team of scientists and technical staff dedicated
to the customer’s studies for a specific period of time and charges the customer at a fixed rate
per employee. We have assessed that the customers simultaneously receive and consume
benefit provided by our performance. Therefore, the performance obligation of research and
development services is satisfied over time and revenue is recognized over the service period.
FINANCIAL INFORMATION
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(c) Drug supply manufacturing services
We provide drug supply manufacturing services to customers. We recognize revenue at
point in time when such services are rendered. The drug supply manufacturing services revenue
is recognized on a net basis as we are acting as an agent because we did not obtain control of
those drugs goods before they are transferred to the customers. Accordingly, during Track
Record Period, we did not recognize any revenues for the drug supply manufacturing services.
Other Income
Bank interest income is recognized on an accrual basis using the effective interest method
by applying the rate that exactly discounts the estimated future cash receipts over the expected
life of the financial instrument or a shorter period, when appropriate, to the net carrying
amount of the financial asset.
Research and Development Costs
All research costs are charged to profit or loss as incurred. Expenditure incurred on
projects to develop new products is capitalized and deferred only when our Group can
demonstrate the technical feasibility of completing the intangible asset so that it will be
available for use or sale, its intention to complete and its ability to use or sell the asset, how
the asset will generate future economic benefits, the availability of resources to complete the
project and the ability to measure reliably the expenditure during the development. Product
development expenditure which does not meet these criteria is expensed when incurred.
Determination of the amounts to be capitalized requires management to make judgments on the
technical feasibility of existing pipelines to be successfully commercialized and bring
economic benefits to our Company.
Property, Plant and Equipment and Depreciation
Property, plant and equipment, other than construction in progress, are stated at cost less
accumulated depreciation and any impairment losses. The cost of an item of property, plant and
equipment comprises its purchase price and any directly attributable costs of bringing the asset
to its working condition and location for its intended use.
Expenditure incurred after items of property, plant and equipment have been put into
operation, such as repairs and maintenance, is normally charged to profit or loss in the period
in which it is incurred. In situations where the recognition criteria are satisfied, the expenditure
for a major inspection is capitalized in the carrying amount of the asset as a replacement.
Where significant parts of property, plant and equipment are required to be replaced at
intervals, our Group recognizes such parts as individual assets with specific useful lives and
depreciates them accordingly.
FINANCIAL INFORMATION
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Depreciation is calculated on the straight-line basis to write off the cost of each item of
property, plant and equipment to its residual value over its estimated useful life. The principal
annual rates used for this purpose are as follows:
Computer and office equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118 19% to 32%
Machinery and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819%
Motor vehicles /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819%
Leasehold improvements /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Shorter of remaining lease terms and
estimated useful lives
Where parts of an item of property, plant and equipment have different useful lives, the
cost of that item is allocated on a reasonable basis among the parts and each part is depreciated
separately. Residual values, useful lives and the depreciation method are reviewed, and
adjusted if appropriate, at least at the end of the reporting periods.
An item of property, plant and equipment including any significant part initially
recognized is derecognized upon disposal or when no future economic benefits are expected
from its use or disposal. Any gain or loss on disposal or retirement recognized in profit or loss
in the year the asset is derecognized is the difference between the net sales proceeds and the
carrying amount of the relevant asset.
Leases
We assess at contract inception whether a contract is, or contains, a lease. A contract is,
or contains, a lease if the contract conveys the right to control the use of an identified asset for
a period of time in exchange for consideration.
We apply a single recognition and measurement approach for all leases, except for
short-term leases and leases of low-value assets. We recognize lease liabilities to make lease
payments and right-of-use assets representing the right to use the underlying assets.
FINANCIAL INFORMATION
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--- page 519 ---
Right-of-use Assets
Right-of-use assets are recognized at the commencement date of the lease (that is the date
the underlying asset is available for use). Right-of-use assets are measured at cost, less
accumulated depreciation and any impairment losses, and adjusted for any remeasurement of
lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities
recognized, initial direct costs incurred, and lease payments made at or before the
commencement date less any lease incentives received. Right-of-use assets are depreciated on
a straight-line basis over the shorter of the lease terms and the estimated useful lives of the
assets as follows:
Office premises /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182 to 10 years
If ownership of the leased asset transfers to our Group by the end of the lease term or the
cost reflects the exercise of a purchase option, depreciation is calculated using the estimated
useful life of the asset.
Lease liabilities
Lease liabilities are recognized at the commencement date of the lease at the present value
of lease payments to be made over the lease term. The lease payments include fixed payments
(including in-substance fixed payments) less any lease incentives receivable, variable lease
payments that depend on an index or a rate, and amounts expected to be paid under residual
value guarantees. The lease payments also include the exercise price of a purchase option
reasonably certain to be exercised by our Group and payments of penalties for termination of
a lease, if the lease term reflects our Group exercising the option to terminate the lease.
In calculating the present value of lease payments, we use our incremental borrowing rate
at the lease commencement date because the interest rate implicit in the lease is not readily
determinable. After the commencement date, the amount of lease liabilities is increased to
reflect the accretion of interest and reduced for the lease payments made. In addition, the
carrying amount of lease liabilities is remeasured if there is a modification, a change in the
lease term, a change in lease payments (e.g., a change to future lease payments resulting from
a change in an index or rate used to determine such lease payments) or a change in assessment
of an option to purchase the underlying asset.
Our lease liabilities are presented in a separate line on the consolidated statements of
financial position.
FINANCIAL INFORMATION
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Short-term leases and leases of low-value assets
We apply the short-term lease recognition exemption to its short-term leases of office
premises (that is those leases that have a lease term of 12 months or less from the
commencement date and do not contain a purchase option). It also applies the recognition
exemption for leases of low-value assets to leases of office equipment that is considered to be
of low value.
Lease payments on 25 short-term leases and leases of low-value assets are recognized as
an expense on a straight-line basis over the lease term.
Share-based Payments
We operate restricted share units schemes. Employees (including directors) of our Group
receive remuneration in the form of share-based payments, whereby employees render services
in exchange for equity instruments (“ equity-settled transactions ”). The cost of equity-settled
transactions with employees is measured by reference to the fair value at the date at which they
are granted. The fair value is determined by an external valuer, further details of which are
given in Note 29 to the Accountants’ Report in Appendix I to this Prospectus.
The cost of equity-settled transactions is recognized in employee benefit expense,
together with a corresponding increase in equity, over the period in which the performance
and/or service conditions are fulfilled. The cumulative expense recognized for equity-settled
transactions at the end of each reporting period until the vesting date reflects the extent to
which the vesting period has expired and our Group’s best estimate of the number of equity
instruments that will ultimately vest. The charge or credit to the statement of profit or loss for
a period represents the movement in the cumulative expense recognized as at the beginning and
end of that period.
Service and non-market performance conditions are not taken into account when
determining the grant date fair value of awards, but the likelihood of the conditions being met
is assessed as part of our Group’s best estimate of the number of equity instruments that will
ultimately vest. Market performance conditions are reflected within the grant date fair value.
Any other conditions attached to an award, but without an associated service requirement, are
considered to be non-vesting conditions. Non-vesting conditions are reflected in the fair value
of an award and lead to an immediate expensing of restricted shares unless there are also
service and/or performance conditions.
For awards that do not ultimately vest because non-market performance and/or service
conditions have not been met, no expense is recognized. Where awards include a market or
non-vesting condition, the transactions are treated as vesting irrespective of whether the market
or non-vesting condition is satisfied, provided that all other performance and/or service
conditions are satisfied.
FINANCIAL INFORMATION
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Where the terms of an equity-settled award are modified, as a minimum an expense is
recognized as if the terms had not been modified, if the original terms of the award are met.
In addition, an expense is recognized for any modification that increases the total fair value of
the share-based payments, or is otherwise beneficial to the employee as measured at the date
of modification. Where an equity-settled award is canceled, it is treated as if it had vested on
the date of cancelation, and any expense not yet recognized for the award is recognized
immediately.
Contract Liabilities
A contract liability is recognized when a payment is received or a payment is due
(whichever is earlier) from a customer before our Group transfers the related goods or services.
Contract liabilities are recognized as revenue when our Group performs under the contract (i.e.,
transfers control of the related goods or services to the customer).
Impairment of Non-financial Assets
Where an indication of impairment exists, or when annual impairment testing for a
non-financial asset is required, the asset’s recoverable amount is estimated. An asset’s
recoverable amount is the higher of the asset’s or cash-generating unit’s value in use and its
fair value less costs of disposal, and is determined for an individual asset, unless the asset does
not generate cash inflows that are largely independent of those from other assets or groups of
assets, in which case the recoverable amount is determined for the cash-generating unit to
which the asset belongs. In testing a cash-generating unit for impairment, a portion of the
carrying amount of a corporate asset (e.g., a headquarters building) is allocated to an individual
cash-generating unit if it can be allocated on a reasonable and consistent basis or, otherwise,
to the smallest group of cash-generating units.
An impairment loss is recognised only if the carrying amount of an asset exceeds its
recoverable amount. In assessing value in use, the estimated future cash flows are discounted
to their present value using a pre-tax discount rate that reflects current market assessments of
the time value of money and the risks specific to the asset. An impairment loss is charged to
profit or loss in the period in which it arises in those expense categories consistent with the
function of the impaired asset.
An assessment is made at the end of each reporting period as to whether there is an
indication that previously recognised impairment losses may no longer exist or may have
decreased. If such an indication exists, the recoverable amount is estimated. A previously
recognised impairment loss of an asset other than goodwill is reversed only if there has been
a change in the estimates used to determine the recoverable amount of that asset, but not to an
amount higher than the carrying amount that would have been determined (net of any
depreciation/amortisation) had no impairment loss been recognised for the asset in prior years.
A reversal of such an impairment loss is credited to profit or loss in the period in which it arises
unless the asset is carried at a revalued amount, in which case the reversal of the impairment
loss is accounted for in accordance with the relevant accounting policy for that revalued asset.
FINANCIAL INFORMATION
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--- page 522 ---
Fair Value Measurement
We measure our financial instruments at fair value at the end of each reporting period.
Fair value is the price that would be received to sell an asset or paid to transfer a liability in
an orderly transaction between market participants at the measurement date. The fair value
measurement is based on the presumption that the transaction to sell the asset or transfer the
liability takes place either in the principal market for the asset or liability, or in the absence of
a principal market, in the most advantageous market for the asset or liability. The principal or
the most advantageous market must be accessible by our Group. The fair value of an asset or
a liability is measured using the assumptions that market participants would use when pricing
the asset or liability, assuming that market participants act in their economic best interest.
A fair value measurement of a non-financial asset takes into account a market
participant’s ability to generate economic benefits by using the asset in its highest and best use
or by selling it to another market participant that would use the asset in its highest and best use.
We use valuation techniques that are appropriate in the circumstances and for which
sufficient data are available to measure fair value, maximising the use of relevant observable
inputs and minimising the use of unobservable inputs.
All assets and liabilities for which fair value is measured or disclosed in the financial
statements are categorized within the fair value hierarchy, described as follows, based on the
lowest level input that is significant to the fair value measurement as a whole:
 Level 1: based on quoted prices (unadjusted) in active markets for identical assets
or liabilities;
 Level 2: based on valuation techniques for which the lowest level input that is
significant to the fair value measurement is observable, either directly or indirectly;
 Level 3: based on valuation techniques for which the lowest level input that is
significant to the fair value measurement is unobservable.
For assets and liabilities that are recognized in the financial statement on a recurring
basis, we determine whether transfers have occurred between levels in the hierarchy by
reassessing categorization (based on the lowest level input that is significant to the fair value
measurement as a whole) at the end of the reporting periods.
During the Track Record Period, we had certain financial liabilities categorized within
Level 3 of fair value measurement (“ Level 3 Financial Liabilities ”). Our Level 3 Financial
liabilities include redemption liabilities on equity shares. Our finance department headed by
the finance manager is responsible for determining the policies and procedures for the fair
value measurement of financial instruments. At the end of the reporting periods, the finance
department analyses the movements in the values of financial instruments and determines the
major inputs applied in the valuation. The valuation is reviewed and approved by the finance
manager.
FINANCIAL INFORMATION
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--- page 523 ---
Fair value measurement of liabilities using
Quoted prices
in active
markets
(Level 1)
Significant
observable
inputs
(Level 2)
Significant
unobservable
inputs
(Level 3) Total
(RMB in thousands)
As of December 31, 2023
Redemption liabilities on
equity shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 1,636,508 1,636,508
As of December 31, 2024
Redemption liabilities on
equity shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 2,214,121 2,214,121
As of April 30, 2025
Redemption liabilities on
equity shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 2,264,813 2,264,813
During the Track Record Period, there were no transfers between Level 1 and Level 2, or
transfers into or out of Level 3 for both financial assets and financial liabilities.
The fair value of redemption liabilities on equity shares have been estimated using a
discounted cash flow and back-solve method based on unobservable inputs including risk-free
interest rate, volatility and discount for lack of marketability (DLOM). We believe that the
estimated fair values resulting from the valuation technique are reasonable, and that they were
the most appropriate values at the end of reporting periods.
In relation to the valuation of the Level 3 Financial Liabilities, our Directors had
reviewed the valuation works and results and the financial statements prepared in accordance
with IFRS, and had obtained sufficient understanding of the valuation model, methodologies
and techniques on which the valuation is based. Based on the above, our Directors are of the
view that the valuation analysis performed during the Track Record Period is fair and
reasonable, and our financial statements are properly prepared. In addition, our Directors are
satisfied with the valuation work for the Level 3 Financial Liabilities performed during the
Track Record Period.
Our Reporting Accountants have conducted their work in accordance with Hong Kong
Standard on Investment Circular Reporting Engagement 200 “Accountants’ Reports on
Historical Financial Information in Investment Circulars” (“ HKSIR 200 ”) issued by the Hong
Kong Institute of Certified Public Accountants in order to express an opinion on the Historical
Financial Information (as defined in the Appendix I to this Prospectus) as a whole. The
Reporting Accountants’ opinion on the Historical Financial Information for the Track Record
Period as a whole is set out in Appendix I to this Prospectus.
FINANCIAL INFORMATION
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--- page 524 ---
DESCRIPTION OF SELECTED COMPONENTS OF CONSOLIDATED STATEMENTS
OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
The following table sets forth our consolidated statements of profit or loss and other
comprehensive income for the periods indicated:
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
REVENUE /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,734 104,703 – 82,149
Cost of sales /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(684) (20,095) – (8,693)
Gross profit /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,050 84,608 – 73,456
Other income and gains /H1118/H1118/H1118/H1118/H111839,964 28,531 6,534 6,122
Research and development
costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(312,738) (332,124) (142,262) (69,818)
Administrative expenses /H1118/H1118/H1118/H1118(49,946) (58,081) (13,881) (23,684)
Other expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(176) (10) (2) (3)
Finance costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,485) (17,963) (13,615) (2,005)
Loss before change in fair
value of redemption
liabilities on equity shares /H1118 (251,331) (295,039) (163,226) (15,932)
Change in fair value of
redemption liabilities on
equity shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(256,993) (382,602) (241,461) (50,692)
LOSS BEFORE TAX /H1118/H1118/H1118/H1118/H1118/H1118(508,324) (677,641) (404,687) (66,624)
Income tax expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118––––
LOSS FOR THE
YEAR/PERIOD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(508,324) (677,641) (404,687) (66,624)
Attributable to:
Owners of the parent /H1118/H1118/H1118/H1118/H1118/H1118/H1118(508,324) (677,641) (404,687) (66,624)
OTHER COMPREHENSIVE
(EXPENSE)/INCOME
Other comprehensive income
(expense) that may be
reclassified to profit or loss
in subsequent periods:
Exchange differences on
translation of foreign
operations /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118734 (1,111) (624) 470
OTHER COMPREHENSIVE
(EXPENSE)/INCOME FOR
THE YEAR /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118734 (1,111) (624) 470
TOTAL COMPREHENSIVE
LOSS FOR THE YEAR /H1118/H1118(507,590) (678,752) (405,311) (66,154)
FINANCIAL INFORMATION
– 515 –


--- page 525 ---
Revenue
During the Track Record Period, our revenue was mainly derived from our collaboration
with Innovent regarding our Core Product GFH925, collaboration with V erastem regarding our
Core Product GFH375 and SELLAS regarding GFH009. For additional information about the
relevant agreements, see “Business — Major Collaboration and Licensing Arrangements.”
Most of the revenue that we recognized during the Track Record Period was generated from
licenses of intellectual property under such collaboration and out-licensing arrangements. We
also generated a small portion of revenue from provision of research and development services,
clinical and regulatory support in connection with the collaboration with SELLAS, including
medical monitoring, data management, statistics and clinical pharmacology. The following
table sets forth components of our revenue.
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
Licenses of intellectual
property /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111871,779 90,035 – 80,742
Sales of goods (1) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 14,668 – 127
Research and development
services /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,955 – – 1,280
Total/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,734 104,703 – 82,149
The following table sets forth of our revenue by Core Products and other products.
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
GFH925 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111871,779 104,703 – 4,310
GFH375 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – – 77,618
Other products /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,955 – – 221
Total/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,734 104,703 – 82,149
Note:
(1) The sales of goods in 2024 was derived from our supply of GFH925 to Innovent. The sales of goods in
the first four months in 2025 was derived from the resale of redundant consumables.
FINANCIAL INFORMATION
– 516 –


--- page 526 ---
Cost of Sales
For the years ended December 31, 2023 and 2024 and four months ended April 30, 2024
and 2025, our cost of sales was RMB0.7 million, RMB20.1 million, nil and RMB8.7 million,
respectively. Our cost of sales primarily consists of costs related to licenses of intellectual
property, costs related to sales of goods and cost related to research and development services.
Costs related to intellectual property licenses primarily consist of fees paid to a third-party
patent holder under licensing arrangements enabled us to proactively mitigate potential
infringement risks associated with GFH925. Under these arrangements, we have agreed to pay
one of the patent holders mid-teen percentage royalties upon the achievement of specified
regulatory and commercialization milestones and receipt of royalty payments for GFH925 in
China, commencing after the execution of the agreement in 2024. See “Business — Intellectual
Property.” Costs related to licenses of intellectual property increased in the four months ended
April 30, 2025 compared to that of the same period of 2024 was primarily due to the increased
royalty payments we received from Innovent in the first four months of 2025, whereas we did
not receive any such payments in the first four months of 2024. Such costs increased in 2024
compared to 2023 was due to the regulatory milestones and royalties we received from
Innovent in late 2024. As such, we had made corresponding royalties payments to the license
holder in late 2024 and the first four months in 2025.
The cost of goods sold primarily reflects the costs incurred in connection with our
fulfillment of drug supply arrangements. During the Track Record Period, the cost related to
sales of goods primarily reflected costs incurred in fulfilling drug supply arrangements for
GFH925. These costs exceeded the corresponding revenue from the sale of GFH925, mainly
because production was based on the first-generation CMC process, which had a higher cost
profile than the selling price to Innovent. We expect the cost of sales to be significantly reduced
once the second-generation CMC process is successfully implemented For details on how we
fulfill our drug supply arrangement, including manufacturing the GFH925 supplied to
Innovent, see “Business — Chemistry, Manufacturing & Controls (“ CMC”) — Collaboration
with CDMO Partners.” The following table sets forth components of our cost of sales.
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
Costs related to licenses of
intellectual property /H1118/H1118/H1118/H1118/H1118/H1118– 12,425 – 595
Cost related to research and
development services /H1118/H1118/H1118/H1118/H1118/H11186 8 4–––
Cost related to sales of goods – 7,670 – 8,098
Total/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118684 20,095 – 8,693
FINANCIAL INFORMATION
– 517 –


--- page 527 ---
Gross Profit
Our gross profit represents our revenue less our cost of sales. For the years ended
December 31, 2023 and 2024 and four months ended April 30, 2024 and 2025, our gross profit
was RMB73.1 million, RMB84.6 million, nil and RMB73.5 million, respectively. The
fluctuation of our gross profit was primarily driven by the fluctuation of the revenue we
recognized, which in turn resulted from the timing of our entry into collaboration agreements
and the payment schedule stipulated in those collaboration agreements.
Other Income and Gains
Our other income and gains primarily consists of (i) government grants, (ii) bank interest
income, (iii) net foreign exchange differences and (iv) fair value gains on financial assets at
fair value through profit and loss (“ FVTPL ”).
The following table sets forth a breakdown of our other income and gains for the periods
indicated.
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
Other income
Government grants /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,786 6,869 678 242
Bank interest income /H1118/H1118/H1118/H1118/H1118/H1118/H111810,767 17,228 4,186 4,986
Gains
Foreign exchange
differences, net /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,818 3,539 959 894
Fair value gains on financial
assets at FVTPL /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,587 402 222 –
Gain on lease reassessment /H1118/H1118/H1118 – 488 488 –
Others /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118651–
Total/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111839,964 28,531 6,534 6,122
Our government grants mainly represent incentives we received from the local
governments. Such incentives are generally one-off in nature and granted primarily for
compensating expenditure arising from our various preclinical and clinical research activities,
as well as our general business operations. Fair value gains on financial assets at FVTPL
mainly represents gains resulting from changes in the fair value of our structured deposits
purchased from reputable banks.
FINANCIAL INFORMATION
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--- page 528 ---
Research and Development Costs
The following table sets forth a breakdown of our research and development costs for the
periods indicated.
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
CMC, materials costs and
preclinical development
costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111899,468 83,438 18,132 16,023
Clinical development costs /H1118/H1118 85,961 57,223 23,085 22,320
Staff costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111878,198 68,992 22,206 19,114
Share-based payment /H1118/H1118/H1118/H1118/H1118/H1118/H111820,283 21,518 7,479 6,965
Depreciation and amortization 15,289 12,595 4,246 3,048
IP management expenses /H1118/H1118/H1118/H11184,300 4,921 1,501 1,060
Termination fee /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 45,404 45,404 –
Patent licensing agreements /H1118/H1118 3,774 28,774 18,868 –
Others /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,465 9,259 1,341 1,288
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118312,738 332,124 142,262 69,818
Our CMC, materials costs and preclinical development costs relate to our process
development of our pipeline products, the costs of materials used in our CMC development and
the costs related to our preclinical development of pipeline product candidates, including costs
related to engaging third-party service providers. Our clinical development costs related to
clinical development of pipeline products, including costs related to engaging third-party
service providers. In the twelve months ended December 31, 2024, we incurred the expenses
of RMB45.4 million to Innovent in relation to the termination of ex-China option for GFH925.
No such costs incurred in the first four months of 2025. Depreciation and amortization includes
depreciation of property, plant and equipment and right-of-use assets and amortization of
intangible assets. IP management expenses primarily relate to our costs related to preparing and
filing patent applications and maintenance of issued patents. Others primarily relates to utilities
and miscellaneous fees for translation, training, transportation, communications and office
expenses, among others. For the years ended December 31, 2023 and 2024, and the four months
ended April 30, 2024, we incurred one-time payments of RMB3.8 million, RMB28.8 million
and RMB18.9 million, respectively, related to patent licensing agreements we entered. No such
costs in the first four months of 2025. For additional information, see “Risk Factors — Risks
Related to Intellectual Property Rights — If we or our collaborators are unable to obtain and
maintain adequate patent and other intellectual property protection for our pipeline products
throughout the selected markets in the world, our ability to successfully commercialize our
pipeline products may be adversely affected.”
FINANCIAL INFORMATION
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--- page 529 ---
For the years ended December 31, 2023 and 2024 and four months ended April 30, 2024
and 2025, we recorded major items of research and development costs attributable to our Core
Products, consisting of (i) CMC, material costs and preclinical development costs, (ii) clinical
development costs, and termination fee and (iii) staff costs, of RMB121.1 million, RMB143.3
million, RMB78.1 million and RMB27.2 million, respectively, representing 38.7%, 43.1%,
54.9% and 39.0% of our total research and development costs in the corresponding periods,
respectively.
The major items of research and development costs attributable to the Core Product
GFH925, consisting of (i) CMC, material costs and preclinical development costs, (ii) clinical
development costs, and termination fee and (iii) staff costs, are RMB81.5 million, RMB101.2
million, RMB73.3 million and RMB13.9 million for the years ended December 31, 2023 and
2024 and four months ended April 30, 2024 and 2025, respectively. Such research and
development costs expressed as a percentage of the total operating expense, defined as the sum
of research and development costs and administrative expenses, are 22.5%, 25.9%, 47.0% and
14.8% for the years ended December 31, 2023 and 2024 and four months ended April 30, 2024
and 2025, respectively.
The following table sets forth major items of research and development costs attributable
to the Core Product GFH925 during the Track Record Period.
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
CMC, material costs and
preclinical development
costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111838,579 16,341 11,224 825
Clinical development costs
and termination fee /H1118/H1118/H1118/H1118/H1118/H1118/H111829,208 71,414 56,415 10,521
Staff costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111813,684 13,406 5,673 2,508
Subtotal of major items /H1118/H1118/H1118/H111881,471 101,161 73,312 13,854
Add: others* /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,979 4,955 4,561 2,428
Exclude: termination fee** /H1118/H1118/H1118 – (45,404) (45,404) –
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111890,450 60,712 32,469 16,282
* Others mainly include IP management expenses, depreciation and amortisation expense and share-based
compensation.
** The termination fee stands for RMB45.4 million to Innovent in connection with the termination of the
ex-China option previously granted to Innovent.
The major items of research and development costs attributable to the Core Product
GF375 expressed as a percentage of the total operating expense, defined as the sum of research
and development costs and administrative expenses, are 10.9%, 10.8%, 3.1% and 14.3% for the
years ended December 31, 2023 and 2024 and four months ended April 30, 2024 and 2025,
respectively.
FINANCIAL INFORMATION
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--- page 530 ---
The following table sets forth major items of research and development costs attributable
to the Core Product GFH375 during the Track Record Period.
For the year ended
December 31,
For the four months ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
CMC, material costs and
preclinical development
costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111830,228 27,506 2,279 (85)
Clinical development costs /H1118/H1118/H1118 – 5,893 – 9,092
Staff costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11189,436 8,712 2,555 4,335
Subtotal of major iterms /H1118/H1118/H1118/H111839,664 42,111 4,834 13,342
Others* /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,779 7,933 1,797 2,717
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111842,443 50,044 6,631 16,059
* Others mainly include IP management expenses, depreciation and amortisation expense and share-based
compensation.
The following table sets forth the research and development costs attributable to each of
our major drug candidates during the Track Record Period:
For the year ended
December 31,
For the year ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
GFH925 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111890,450 60,712 32,469 16,282
GFH375 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111842,443 50,044 6,631 16,059
GFH018 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111848,818 20,887 7,800 821
GFH009 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111839,550 23,317 9,805 2,202
Other candidates /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111887,703 102,986 21,285 34,454
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118308,964 257,946 77,990 69,818
Payment made to pre-empt
potential issues* /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,774 28,774 18,868 –
Terminations fee** /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 45,404 45,404 –
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118312,738 332,124 142,262 69,818
* The payment was made to pre-empt potential issues over GFH925 in China with third-party patent
holders such that these third-party patent holders’ patents in China would not affect the Company’s
freedom to operate GFH925 and its commercialization in China.
** The termination fee stands for RMB45.4 million to Innovent in connection with the termination of the
ex-China option previously granted to Innovent.
FINANCIAL INFORMATION
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The following table sets forth the clinical development costs (including termination fee)
as part of the R&D expenses incurred for the Core Products at different jurisdictions where the
clinical trials are conducted in each year during the Track Record Period.
For the year ended December 31,
(RMB in
thousands) 2023 2024
Core Products CHN AUS U.S. EU total CHN AUS U.S. EU TOTAL
GF925 /H1118/H1118/H1118/H1118/H1118/H1118– – 432 28,776 29,208 – – 794 70,620 71,414
GF375 /H1118/H1118/H1118/H1118/H1118/H1118––––– 5,89 3––– 5,893
For the four months ended April 30,
(RMB in
thousands) 2024 2025
Core Products CHN AUS U.S. EU TOTAL CHN AUS U.S. EU total
GF925 /H1118/H1118/H1118/H1118/H1118/H1118– – 591 55,824 56,415 – – 45 10,476 10,521
GF375 /H1118/H1118/H1118/H1118/H1118/H1118––––– 9,09 2––– 9,092
Administrative Expenses
During the Track Record Period, our administrative expenses primarily consisted of (i)
staff costs, including wages, bonus, social insurance and other welfare for our administrative
personnel, (ii) professional services expenses primarily in relation to our equity financing and
business collaboration activities, and annual retainer fees of our legal counsels, (iii) office,
traveling and business-related expenses, a vast majority of which consisted of office expenses
and traveling expenses, (iv) depreciation of property, plant and equipment and right-of-use
assets and amortization of intangible assets, (v) Share-based payment compensation, (vi)
listing expense and (vii) others. The following table sets forth a breakdown of our
administrative expenses for the periods indicated.
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
Staff costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111818,771 19,739 6,638 6,004
Share-based payment
compensation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816,685 5,367 2,107 1,810
Professional services
expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,853 7,306 2,428 4,626
Listing expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 18,363 – 9,228
Office, traveling and business-
related expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,818 4,436 1,664 1,155
Depreciation and amortization /H1118 2,747 1,697 712 459
Others /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,072 1,173 332 402
Total/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111849,946 58,081 13,881 23,684
FINANCIAL INFORMATION
– 522 –


--- page 532 ---
Other Expenses
During the Track Record Period, we incurred a small amount of other expenses, which
was primarily attribute to the loss on disposals of property, plant and equipment. Other
expenses for the years ended December 31, 2023 and 2024 and four months ended April 30,
2024 and 2025 were RMB176 thousand, RMB10 thousand, RMB2 thousand and RMB3
thousand, respectively.
Finance Costs
Our finance costs consist of (i) transaction cost on issue of redemption liabilities on
equity shares, (ii) interest on lease liabilities; (iii) imputed interest expense on other payables
and (iv) interest on bank borrowings. The following table sets forth the components of our
finance costs for the periods indicated.
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
Transaction costs on issue
of redemption liabilities
on equity shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 11,840 11,840 –
Interest on lease liabilities /H1118/H1118/H11181,366 1,112 389 271
Imputed interest expenses
on other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 4,134 1,334 1,116
Interest on bank borrowings /H1118/H1118 119 877 52 618
Total/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,485 17,963 13,615 2,005
The transaction costs on issue of redemption liabilities on equity shares mainly represent
the consulting service fees in connection with our equity financing. We incurred imputed
interest expenses on other payables for the twelve months ended December 31, 2024 primarily
because we are committed to pay Innovent in several installments in relation to the termination
of ex-China option for GFH925.
Change in Fair Value of Redemption Liabilities on Equity Shares
We have recognized the equity shares that we issued in the several rounds of investments
that we historically received as redemption liabilities on equity shares. For additional
information about those historical investments, see “History, Development and Corporate
Structure” in this Prospectus. Change in fair value of redemption liabilities on equity shares
represents changes in fair value of the equity shares issued by us. The change in the fair value
of our issued equity shares is charged to profit or loss.
FINANCIAL INFORMATION
– 523 –


--- page 533 ---
We used the discounted cash flow and back-solve method to determine the underlying
share value of our Company and performed an equity allocation based on the option pricing
model to arrive at the fair value of the redemption liabilities on equity shares as of the end of
each reporting period with reference to valuation report carried out by an independent valuer.
For additional information, see Note 25 of the Accountants’ Report set out in Appendix I to this
Prospectus.
Upon Listing, we do not expect to recognize any further change in fair value of
redemption liabilities on equity shares, as the redemption right, and the related compulsory
liquidation rights, will be automatically terminated upon Listing. For additional information,
see “History, Development and Corporate Structure” in this Prospectus.
Income Tax
We are subject to income tax on an entity basis on profits arising in or derived from the
jurisdictions in which members of our Group are domiciled and operate.
PRC
Under the Law of the PRC on Enterprise Income Tax (the “ EIT Law ”) and
Implementation Regulation of the EIT Law, the Enterprise Income Tax (“ EIT”) rate of the PRC
subsidiaries was 25% during the Track Record Period except for certain members of the Group,
which was subject to tax concession set out below.
Our Company was accredited as a “High and New Technology Enterprise” (“ HNTE ”) in
2022. Therefore, our Company was entitled to a preferential EIT rate of 15% during the Track
Record Period. The qualification as a HNTE Enterprise is subject to review by the relevant tax
authority in the PRC every three years.
In 2022, the Ministry of Finance and the State Administration of Taxation issued the
Notice on the Further Implementation of Preferential Income Tax for Small and Micro
Enterprises (Cai Shui [2022] No. 13), which provides that the portion of annual taxable income
of small and micro enterprises exceeding RMB1.0 million but not exceeding RMB3.0 million
shall be deducted to 25% of the taxable income and subject to income tax at a rate of 20% for
the period from January 1, 2022 to December 31, 2027. GenFleet Zhejiang, GenFleet Beijing
and GenFleet Shanghai were recognized as Small and Micro Enterprises and were entitled to
a preferential tax rate of 20% during the Track Record Period.
Australia
GenFleet Australia, which was incorporated in Australia with less than AUD50.0 million
of turnover, was subject to income tax at the rate of 25% on the estimated assessable profits
during the Track Record Period.
The United States
GenFleet U.S., the subsidiary incorporated and operated in the United States, was subject
to the federal corporate income tax rate at 21% during the Track Record Period.
FINANCIAL INFORMATION
– 524 –


--- page 534 ---
PERIOD-TO-PERIOD COMPARISON OF RESULTS OF OPERATIONS
Four Months Ended April 30, 2024 Compared to Four Months Ended April 30, 2025
Revenue
For the four months ended April 30, 2025, we recognized RMB77.6 million revenue
related to GFH375 in connection with V erastem’s exercise of its option under the V erastem
Agreement in January 2025. We also recognized RMB4.3 million royalty related to GFH925
from Innovent. We have also recognized small amount of revenue from sale of goods and R&D
services for the first four months in 2025. We did not recognize any revenue in the four months
ended April 30, 2024.
Cost of Sales
For the four months ended April 30, 2025, we recognized cost of sales of RMB8.7
million, which was primarily attributable to cost related to sales of goods of RMB8.1 million
in relation to the fulfillment of drug supply arrangement. We did not recognize any cost of sales
for the four months ended April 30, 2024.
Gross Profit
For the four months ended April 30, 2025, we recognized gross profit of RMB73.5
million. As we did not recognize any revenue or incur cost of sales for the four months ended
April 30, 2024, our gross profit was nil for the same period.
Other Income and Gains
Our other income and gains remained relatively stable at RMB6.1 million for the four
months ended April 30, 2025 compared to RMB6.5 million for the four months ended April 30,
2024. The decrease was primarily attributable to the decrease of RMB0.4 million in
government grants, and decrease of RMB0.7 million in gains on (i) fair value gains on financial
assets at FVTPL and (ii) lease reassessment in the first four months of 2025, partially offset
the by the increase of bank interest income of RMB0.8 million in the four months ended April
30, 2025.
Research and Development Costs
Our research and development costs decreased by 50.9% from RMB142.3 million for the
four months ended April 30, 2024 to RMB69.8 million for the four months ended April 30,
2025, primarily due to incurred expenses of RMB45.4 million on termination of Ex-China
option and RMB18.9 million under the patent licensing agreements, each in the first four
months of 2024. No such costs incurred in the first four months of 2025.
FINANCIAL INFORMATION
– 525 –


--- page 535 ---
Administrative Expenses
Our administrative expenses increased by 70.5% from RMB13.9 million for the four
months ended April 30, 2024 to RMB23.7 million for the four months ended April 30, 2025.
The increase was mainly driven by an increase of listing related expenses incurred in 2025.
Finance Costs
Our finance costs decreased significantly from RMB13.6 million for the four months
ended April 30, 2024 to RMB2.0 million for the four months ended April 30, 2025. The
decrease was primarily attributable to the decrease of transaction cost on issue of redemption
liabilities on equity shares by RMB11.8 million as a result of professional fees in connection
with our series C+ financing with redemption features in the first four months of 2024. We did
not recognize such transaction cost in the first four months of 2025.
Change in Fair V alue of Redemption Liabilities on Equity Shares
Our change in fair value of redemption liabilities on equity shares decreased from
RMB241.5 million for the four months ended April 30, 2024 to RMB50.7 million for the four
months ended April 30, 2025, primarily due to the moderate growth in value of our Company.
Loss for the Period
For the reasons described above, our loss for the period decreased from RMB404.7
million for the four months ended April 30, 2024 to RMB66.6 million for the four months
ended April 30, 2025.
Y ear Ended December 31, 2024 Compared to Y ear Ended December 31, 2023
Revenue
Our revenue increased from RMB73.7 million for the year ended December 31, 2023 to
RMB104.7 million for the year ended December 31, 2024. Most of the revenue that we
recognized during the Track Record Period was generated from licenses of intellectual property
under such collaboration and out-licensing arrangements, and the increase in revenue was in
line with the timing of our entry into the relevant licensing agreements and the payment
schedules stipulated in those agreements and whether milestones triggering the payments were
reached.
Cost of Sales
Our cost of sales increased significantly from RMB0.7 million in 2023 to RMB20.1
million in 2024, which was primarily attributable to the cost of GFH925 we supplied to
Innovent.
FINANCIAL INFORMATION
– 526 –


--- page 536 ---
Gross Profit
As a result of the foregoing, our gross profit increased from RMB73.1 million for the year
ended December 31, 2023 to RMB84.6 million for the year ended December 31, 2024.
Other Income and Gains
Our other income and gains decreased from RMB40.0 million for the year ended
December 31, 2023 to RMB28.5 million for the year ended December 31, 2024. The decrease
was primarily attributable to the decrease in government grants of RMB14.9 million and the
decrease in fair value gains on financial assets at FVTPL by RMB3.2 million because the
structured deposits reached maturity in 2023 and the reduced amount of new structured
deposits we purchased in the year ended December 31, 2024, partially offset by the increase
of bank interest income of RMB6.5 million in the year ended December 31, 2024.
Research and Development Costs
Our research and development costs increased from RMB312.7 million for the year ended
December 31, 2023 to RMB332.1 million for the year ended December 31, 2024, primarily due
to an increase of RMB28.8 million in others, primarily attributable to an one-time payment of
RMB28.8 million under the patent licensing agreements, and was partially offset by a decrease
of RMB9.2 million in staff costs.
Administrative Expenses
Our administrative expenses increased from RMB49.9 million for the year ended
December 31, 2023 to RMB58.1 million for the year ended December 31, 2024. The increase
was mainly driven by an increase of listing expense by RMB18.4 million.
Finance Costs
Our finance costs increased significantly from RMB1.5 million for the year ended
December 31, 2023 to RMB18.0 million for the year ended December 31, 2024. The increase
was primarily attributable to the increase of transaction cost on issue of redemption liabilities
on equity shares by RMB11.8 million as a result of professional fees in connection with our
series C+ financing with redemption features in 2024.
Change in Fair V alue of Redemption Liabilities on Equity Shares
Our change in fair value of redemption liabilities on equity shares increased from
RMB257.0 million for the year ended December 31, 2023 to RMB382.6 million for the year
ended December 31, 2024, primarily due to the increase in value of our Company.
Loss for the Period
For the reasons described above, our loss for the period increased from RMB508.3
million for the year ended December 31, 2023 to RMB677.6 million for the year ended
December 31, 2024.
FINANCIAL INFORMATION
– 527 –


--- page 537 ---
DISCUSSION OF CERTAIN SELECTED ITEMS FROM THE CONSOLIDATED
STATEMENTS OF FINANCIAL POSITION
The following table sets forth our consolidated statements of financial position as of the
dates indicated.
As of December 31, As of April 30,
2023 2024 2025
(RMB in thousands)
NON-CURRENT ASSETS
Property, plant and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H111820,601 12,328 10,325
Right-of-use assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,361 15,412 14,212
Intangible assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,401 1,257 1,198
Prepayments, other receivables and
other assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,275 9,576 9,730
Time deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,752 – –
Total non-current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111885,390 38,573 35,465
CURRENT ASSETS
Inventories /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,058 5,586 918
Trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
Prepayments, other receivables and
other assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111844,136 58,594 56,013
Time deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 32,790 –
Cash and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118332,197 362,125 390,766
Total current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118450,744 568,248 545,215
CURRENT LIABILITIES
Trade and other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111882,847 181,733 159,406
Interest-bearing bank borrowings /H1118/H1118/H1118/H1118/H11185,312 51,128 85,117
Contract liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118101,914 42,204 12,348
Redemption liabilities on equity shares 1,636,508 2,214,121 2,264,813
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,526 4,243 3,345
Total current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,832,107 2,493,429 2,525,029
Net current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,381,363) (1,925,181) (1,979,814)
Total assets less current liabilities /H1118/H1118/H1118(1,295,973) (1,886,608) (1,944,349)
NON-CURRENT LIABILITIES
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820,835 13,977 12,861
Deferred income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185 0 3––
Trade and other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 55,676 56,429
Total non-current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,338 69,653 69,290
Net liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,317,311) (1,956,261) (2,013,639)
DEFICIENCY IN EQUITY
Equity attributable to owners of the
Company
Paid-in capital/Share capital /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111822,027 26,774 26,774
Reserves /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,339,338) (1,983,035) (2,040,413)
Controlling interests /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,317,311) (1,956,261) (2,013,639)
Net deficits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,317,311) (1,956,261) (2,013,639)
FINANCIAL INFORMATION
– 528 –


--- page 538 ---
The following table sets forth our current assets and current liabilities as of the dates
indicated.
As of December 31,
As of
April 30,
As of
July 31,
2023 2024 2025 2025
(RMB in thousands)
(unaudited)
Current assets
Inventories /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,058 5,586 918 892
Trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518 93,363
Prepayments, other receivables
and other assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111844,136 58,594 56,013 55,231
Time deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 32,790 – –
Cash and cash equivalents /H1118/H1118/H1118/H1118/H1118332,197 362,125 390,766 358,310
Total current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118450,744 568,248 545,215 507,796
Current liabilities
Trade and other payables /H1118/H1118/H1118/H1118/H1118/H111882,847 181,733 159,406 183,607
Interest-bearing bank borrowings 5,312 51,128 85,117 74,209
Contract liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118101,914 42,204 12,348 32,759
Redemption liabilities on equity
shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,636,508 2,214,121 2,264,813 3,199,126
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,526 4,243 3,345 3,419
Total current liabilities /H1118/H1118/H1118/H1118/H1118/H11181,832,107 2,493,429 2,525,029 3,493,120
NET CURRENT LIABILITIES (1,381,363) (1,925,181) (1,979,814) (2,985,324)
During the Track Record Period, we had net liabilities position, which was primarily due
to the significant total comprehensive loss for the year/period in each year/period of the Track
Record Period caused by the significant redemption liabilities on equity shares and increased
research and development costs in each year/period of the Track Record Period. The increase
of net liabilities from RMB1,956.3 million as of December 31, 2024 to RMB2,013.6 million
as of April 30, 2025 was primarily due to the loss for the period year of RMB66.6 million
mainly driven by the research and development costs we incurred and an increase in fair value
of the Shares held by Pre-IPO Investors. The increase of net liabilities from RMB1,317.3
million as of December 31, 2023 to RMB1,956.3 million as of December 31, 2024 was
primarily due to the loss for the year of RMB677.6 million mainly driven by the research and
development costs we incurred and an increase in fair value of the Shares held by Pre-IPO
Investors.
FINANCIAL INFORMATION
– 529 –


--- page 539 ---
The increase of net current liabilities by RMB543.8 million from RMB1,381.4 million as
of December 31, 2023 to RMB1,925.2 million as of December 31, 2024 was primarily driven
by an increase of (i) redemption liabilities on equity shares by RMB577.6 million, (ii) trade and
other payables of RMB98.9 million primarily from the payables under the termination of the
ex-China option and (iii) interest-bearing bank borrowings of RMB45.8 million, partially
offset by an increase of (i) time deposits and cash and cash equivalents of RMB62.7 million
and (ii) trade receivables of RMB36.8 million as well as a decrease in contract liabilities of
RMB59.7 million, primarily attributable to the termination in January 2024 of the ex-China
option previously granted to Innovent for GFH925, as well as the recognition of contractual
obligations under the V erastem Agreement following the receipt of payments in 2024.
Our net current liabilities as of April 30, 2025 remained relatively stable and increased
by 2.8% to RMB1,979.8 million, primarily due to the increase of interest-bearing bank
borrowings of RMB34.0 million and redemption liabilities on equity shares by RMB50.7
million, partially offset by a decrease in trade and other payables of RMB22.3 million and
contract liabilities of RMB29.9 million.
The increase of net liabilities by RMB639.0 million from December 31, 2023 to
December 31, 2024 was primarily driven by our total comprehensive loss for the year in 2024
of RMB678.8 million, which was further driven by the significant amount of research and
development costs of RMB332.1 million and change in fair value of redemption liabilities on
equity shares of RMB382.6 million.
Our net liabilities as of April 30, 2025 remained relatively stable and increased by
RMB57.3 million to RMB2,013.6 million, primarily due to our total comprehensive loss for the
period in the first four months of 2025 of RMB66.2 million, which was further driven by the
significant amount of research and development costs of RMB69.8 million and change in fair
value of redemption liabilities on equity shares of RMB50.7 million.
Upon the Listing, we expect to record equity shares issued in connection with Pre-IPO
Investments as equity and do not expect to recognize any redemption liabilities on these equity
shares, or recognize any future loss or gains in connection with such redemption liabilities on
our consolidated statements of profit or loss and other comprehensive income. We therefore
expect to have a net asset position rather than a net liability position upon the Listing. We will
also take additional measures to improve our financial position. For additional information, see
“— Liquidity and Capital Resources.”
FINANCIAL INFORMATION
– 530 –


--- page 540 ---
Property, plant and equipment
Our property, plant and equipment primarily consists of machinery and equipment,
computer and office equipment, motor vehicles and leasehold improvements. The following
table sets forth a breakdown of the net carrying amount of our property, plant and equipment
as of the dates indicated.
As of December 31, As of April 30,
2023 2024 2025
(RMB in thousands)
Machinery and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111817,812 11,419 9,581
Computer and office equipment /H1118/H1118/H1118/H1118/H1118/H11181,280 576 492
Motor vehicles /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118575 333 252
Leasehold improvements /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11189 3 4––
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820,601 12,328 10,325
Our property, plant and equipment decreased from RMB20.6 million as of December 31,
2023 to RMB12.3 million as of December 31, 2024, primarily attributable to the depreciation
of machinery and equipment of RMB6.4 million for the year ended December 31, 2024.
Our property, plant and equipment decreased from RMB12.3 million as of December 31,
2024 to RMB10.3 million as of April 30, 2025, primarily attributable to the depreciation of
machinery and equipment of RMB1.8 million for the four months ended April 30, 2025.
Right-of-use assets
Our right-of-use assets are primarily related to our leased office premises used in our
operations. Leases of office premises generally have lease terms between two and 10 years. Our
right-of-use assets decreased from RMB23.4 million as of December 31, 2023 to RMB15.4
million as of December 31, 2024, primarily due to a depreciation charge of RMB5.4 million
and reassessment of a lease term arising from a decision not to exercise the extension option,
which decreased the right-of-use assets by RMB2.5 million in the year ended December 31,
2024. Our right-of-use assets decreased from RMB15.4 million as of December 31, 2024 to
RMB14.2 million as of April 30, 2025, primarily due to a depreciation charge of RMB1.4
million in the four months ended April 30, 2025.
Intangible assets
Our intangible assets include computer software related to our business operations. The
net carrying amount of our intangible assets slightly decreased from RMB1.4 million as of
December 31, 2023 to RMB1.3 million as of December 31, 2024, primarily attributable to the
amortization of our compute software in the year ended December 31, 2024. The net carrying
amount of our intangible assets slightly decreased to RMB1.2 million as of April 30, 2025,
primarily attributable to the amortization of our compute software of RMB59 thousand in the
four months ended April 30, 2025.
FINANCIAL INFORMATION
– 531 –


--- page 541 ---
Trade receivables
During the Track Record Period, our trade receivables consisted of receivables from our
collaboration partners for payment (including milestone payment) obligations set out in the
relevant agreements. The following table sets forth the details of our trade receivables as of the
dates indicated.
As of December 31, As of April 30,
2023 2024 2025
(RMB in thousands)
Trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
Impairment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
Our trade receivables increased from RMB72.4 million as of December 31, 2023 to
RMB109.2 million as of December 31, 2024 and decreased to RMB97.5 million as of April 30,
2025, generally in line with the research and development activities of our collaborators in
relation to the out-license and collaboration programs, as well as the milestones achieved
within such periods.
The following table sets forth an aging analysis of our trade receivables as of the dates
indicated.
As of December 31, As of April 30,
2023 2024 2025
(RMB in thousands)
Within 1 year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
As of July 31, 2025, RMB7.6 million, or 7.8% of our trade receivables as of April 30,
2025 had been subsequently settled. The Company does not expect any material recoverability
issues with respect to the Company’s trade receivables. As of April 30, 2025, approximately
92.6% of the trade receivables were due from Innovent, arising from the licensing and
collaboration agreements. Innovent is a limited liability company listed on the Hong Kong
Stock Exchange. Based on the financial information disclosed in its latest annual report, there
are no indications of concerns regarding its ability to meet repayment obligations. In addition,
Innovent has been consistently fulfilling its payment obligations, with trade receivables being
settled on an ongoing basis.
FINANCIAL INFORMATION
– 532 –


--- page 542 ---
Prepayments, other receivables and other assets
Our prepayments, other receivables and other assets primarily consisted of (i)
prepayments for research and development services; (ii) value-added tax recoverable,
representing value-added tax paid by us on purchases that are deductible against future
value-added tax payable; (iii) rental and other deposits, with deposits mainly in connection
with our offices as well as third-party research and development services; (iv) other
prepayments including our prepayments for various business-related activities, such as patent
filing, legal consulting and financing; and (v) other receivables including disbursement on
behalf of Innovent and SELLAS, which are to be borne by Innovent and SELLAS, in
connection with our research and/or manufacturing activities.
The following table sets forth the components of our prepayments, other receivables and
other assets as of the dates indicated:
As of December 31, As of April 30,
2023 2024 2025
(RMB in thousands)
Non-current
Rental and other deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,480 1,514 1,514
V alue-added tax recoverable /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,635 7,865 8,017
Others /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118160 197 199
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,275 9,576 9,730
Current
Prepayments for research and
development and other services /H1118/H1118/H1118/H111826,755 22,194 26,176
Rental and other deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11187,375 7,139 3,576
V alue-added tax recoverable /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,537 10,719 16,771
Deferred listing expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 3,122 4,674
Other receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,469 15,420 4,816
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111844,136 58,594 56,013
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111852,411 68,170 65,743
Our prepayments, other receivables and other assets increased from RMB52.4 million as
of December 31, 2023 to RMB68.2 million as of December 31, 2024, primarily due to the
increase of value-added tax recoverable by RMB7.4 million and payment advances for certain
CMC activities of RMB15.0 million.
Our prepayments, other receivables and other assets decreased from RMB68.2 million as
of December 31, 2024 to RMB65.7 million as of April 30, 2025, primarily due to the decrease
of other receivables of RMB10.6 million, partially offset by the increase of value-added tax
recoverable of RMB6.1 million and prepayments for research and development services and
other services of RMB4.0 million.
As of July 31, 2025, RMB5.0 million, or 9.0% of the current portion of our prepayments,
other receivables and other assets as of April 30, 2025 had been subsequently settled.
FINANCIAL INFORMATION
– 533 –


--- page 543 ---
Time deposits
All time deposits held at bank with original maturities over three months and less than one
year with corresponding interest receivables are classified as our current assets. Time deposits
held at bank with original maturities over one year with corresponding interest receivables are
classified as our non-current assets. Most of our time deposits were denominated in the U.S.
dollar.
As of December 31, As of April 30,
2023 2024 2025
(RMB in thousands)
Time deposits over three months but
less than one year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 32,790 –
Time deposits over one year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,752 – –
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,752 32,790 –
Our time deposits remained relatively stable at RMB31.8 million as of December 31,
2023 and RMB32.8 million as of December 31, 2024, respectively.
We do not have time deposits as of April 30, 2025.
Inventories
During the Track Record Period, we had a relatively insignificant amount of inventories,
which primarily consisted of reagents and consumables for preclinical activities. Our
inventories increased from RMB2.1 million as of December 31, 2023 to RMB5.6 million as of
December 31, 2024, generally in line with our R&D activities. Our inventories further
decreased to RMB0.9 million as of April 30, 2025, generally in line with our R&D activities.
As of July 31, 2025, RMB0.2 million, or 18.8% of our inventories as of April 30, 2025
had been consumed.
Financial assets at FVTPL
Our financial assets at FVTPL during the Track Record Period represents the structured
deposits we purchased as part of our wealth management to generate reasonable low risk
returns. The purchases of structured deposits were approved by our senior management team.
Such structure deposits were principal guaranteed and purchased from reputable banks in the
PRC. We had financial assets at FVTPL of nil, nil and nil as of December 31, 2023 and
December 31, 2024 and April 30, 2025, respectively, since our financial assets at FVTPL
reached maturity in 2023, and our financial assets at FVTPL purchased in 2024 reached
maturity before December 31, 2024, and we did not purchase such financial assets in the first
four months of 2025.
FINANCIAL INFORMATION
– 534 –


--- page 544 ---
With regards to the purchase of wealth management products, we have formulated the
investment policy of diversifying risks and generating steady returns on the premise of
ensuring the safety of funds. Our finance manager and the finance department are mainly
responsible for making, implementing and supervising our investment decisions. We have
implemented the following treasury policies and internal authorization controls:
 We have formulated the internal control measures to control our process of
investment in wealth management products;
 Our Board authorizes and supervises the finance manager to approve through a strict
review and decision-making process, and our General Manager and/or Chairman of
the Board are responsible for the approval of our material investments in wealth
management products;
 Our finance department is responsible for the analysis and research of investments
in wealth management products, as well as the long-term routine management of
such investments; and
 Investments in wealth management products could be made when we have surplus
cash that is not required for our short-term working capital purposes and in no event
beyond the amount authorized by our senior management team.
Prior to making an investment, we evaluate the sufficiency of our remaining working
capital for our business needs, operating activities, research and development and capital
expenditures following the proposed investment. We adopt a prudent approach in selecting
financial assets. Our investment strategy related to financial assets focuses on minimizing the
financial risks by reasonably and conservatively matching the maturities of the portfolio to
anticipated operating cash needs, while generating desirable investment returns for the benefits
of our shareholders. We make investment decisions related to financial assets on a case-by-case
basis after thoroughly considering a number of factors, including but not limited to the
macro-economic environment, general market conditions, risk control and credit of invested
subjects, our own working capital conditions, and the expected profit or potential loss of the
investment. To control our risk exposure, we have in the past sought and may continue in the
future to seek other low-risk wealth management products.
To the extent that we will have surplus cash that is not required for our short-term
working capital purposes, we will continue to consider investing in wealth management
products taking into account the considerations above as appropriate to be in our best interest.
Our investments in wealth management products after the Listing will be subject to compliance
with Chapter 14 of the Listing Rules.
FINANCIAL INFORMATION
– 535 –


--- page 545 ---
Cash and cash equivalents
Our cash and cash equivalents primarily consisted of cash at banks. The following table
sets forth a breakdown of our cash and cash equivalents by currency type as of the dates
indicated.
As of December 31, As of April 30,
2023 2024 2025
(RMB in thousands)
Denominated in:
– Renminbi /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111875,183 24,714 74,224
– U.S. dollar /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118238,818 319,040 303,165
– Australian dollar /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111818,196 18,371 13,377
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118332,197 362,125 390,766
Our cash and cash equivalents increased from RMB332.2 million as of December 31,
2023 to RMB362.1 million as of December 31, 2024 and further to RMB390.8 million as of
April 30, 2025. For an analysis on cash flows during the Track Record Period, see “—
Liquidity and Capital Resources.”
Trade and other payables
Our trade and other payables primarily related to our purchases of materials and
third-party contracting services in relation to our research and development activities. The
following table sets forth a breakdown of our trade and other payables.
As of December 31, As of April 30,
2023 2024 2025
(RMB in thousands)
Current:
Trade payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,355 6,292 10,836
Payroll payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819,656 17,711 8,561
Accrued expenses for research and
development services /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111849,335 73,704 63,964
Accrued listing expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 12,706 5,380
Other taxes payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,088 987 684
Other payables
– License-out agreement option
termination fee /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 68,573 69,112
– Accrued expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,910 1,216 688
– Others /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118503 544 181
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111882,847 181,733 159,406
FINANCIAL INFORMATION
– 536 –


--- page 546 ---
As of December 31, As of April 30,
2023 2024 2025
(RMB in thousands)
Non-current:
License-out agreement option
termination fee /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 55,676 56,429
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 55,676 56,429
The current portion of our trade and other payables increased from RMB82.8 million as
of December 31, 2023 to RMB181.7 million as of December 31, 2024, primarily due to the
license-out agreement option termination fee of RMB68.6 million as of December 31, 2024
primarily in relation to our agreement with Innovent in January 2024 to terminate the ex-China
option previously granted to Innovent regarding GFH925. We also had a non-current portion
of the trade and other payables of RMB55.7 million due to the same reason. For additional
information about the agreement, see “Business — Major Collaboration and Licensing
Arrangements — Supplementary Agreement with Innovent.”
The current portion of our trade and other payables decreased from RMB181.7 million as
of December 31, 2024 to RMB159.4 million as of April 30, 2025, primarily due to (i) the
increase in trade payables of RMB4.5 million, (ii) the decrease in payroll payables of RMB9.2
million and (iii) the decrease in accrued listing expense of RMB7.3 million. We had a
non-current portion of the trade and other payables, representing license-out agreement option
termination fee of RMB56.4 million as of April 30, 2025 primarily in relation to our agreement
with Innovent in January 2024 to terminate the ex-China option previously granted to Innovent
regarding GFH925. For additional information about the agreement, see “Business — Major
Collaboration and Licensing Arrangements — Supplementary Agreement with Innovent.”
The following table sets forth an aging analysis of our trade payables based on the invoice
date as of the dates indicated.
As of December 31, As of April 30,
2023 2024 2025
(RMB in thousands)
Within 3 months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,355 6,292 10,836
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,355 6,292 10,836
Our trade payables are non-interest-bearing and are typically settled on terms of one to
three months of the invoice date.
As of July 31, 2025, RMB10.8 million, or 100.0%, of our trade payables as of April 30,
2025 had been subsequently settled.
FINANCIAL INFORMATION
– 537 –


--- page 547 ---
Contract liabilities
Our contract liabilities primarily represented the obligations to transfer the ex-China right
of GFH925 pursuant to an ex-China option to Innovent and the obligations to transfer the
ex-China right of GFH375 pursuant to an option granted to V erastem, respectively.
In January 2024, we entered into an agreement with Innovent to terminate the ex-China
option of GFH925. In January 2025, V erastem exercised the ex-China option of GFH375. We
have gradually fulfilled our contractual obligations under the aforementioned contracts in the
Track Record Period, which is the primarily underlying reason for a decrease of contractual
liabilities from RMB101.9 million as of December 31, 2023 to RMB42.2 million as of
December 31, 2024 and further to RMB12.3 million as of April 30, 2025. For additional
information about our agreements with Innovent, see “Business — Major Collaboration and
Licensing Arrangements.”
As of July 31, 2025, RMB0.4 million, or 3.3% of our outstanding contract liabilities as
of April 30, 2025 has been subsequently recognized as revenue.
Redemption liabilities on equity shares
We have recognized the equity shares that we issued in the several rounds of investments
that we historically received as redemption liabilities on equity shares. For additional
information about those historical investments, see “History, Development and Corporate
Structure” and Note 25 of the Accountants’ Report set out in Appendix I to this Prospectus.
During the Track Record Period, we had increased redemption liabilities on equity shares
from RMB1,636.5 million as of December 31, 2023 to RMB2,214.1 million as of December 31,
2024 and further to RMB2,264.8 million as of April 30, 2025. Such increments were in line
with our issuance of additional equity shares with redemption features to raise capital and the
increase in value of Shares held by Pre-IPO Investors.
Lease liabilities
The following table sets forth our lease liabilities as of the dates indicated.
As of December 31, As of April 30,
2023 2024 2025
(RMB in thousands)
Current /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,526 4,243 3,345
Non-current /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820,835 13,977 12,861
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111826,361 18,220 16,206
FINANCIAL INFORMATION
– 538 –


--- page 548 ---
Our lease liabilities decreased from RMB26.4 million as of December 31, 2023 to
RMB18.2 million as of December 31, 2024, primarily attributable to (i) our lease payments in
the year ended December 31, 2024 of RMB6.3 million and (ii) a reassessment of a lease term
arising from a decision not to exercise the extension option, which decreased our lease
liabilities by RMB3.0 million as of December 31, 2024.
Our lease liabilities further decreased to RMB16.2 million as of April 30, 2025 primarily
due to our lease payments in the first four months of 2025 of RMB2.5 million.
Deferred income
Our deferred income decreased from RMB0.5 million as of December 31, 2023 to nil as
of December 31, 2024, primarily due to recognizing RMB6.9 million of government grants as
income in 2024, partially offset by a receipt of government grants of RMB6.4 million during
the same period.
We had RMBnil deferred income as of April 30, 2025.
LIQUIDITY AND CAPITAL RESOURCES
Overview
We monitor and maintain a level of cash and cash equivalents deemed adequate to finance
our operations and mitigate the effects of fluctuations in cash flows. In addition, we monitor
the utilization of borrowings and, from time to time, evaluate the options to renew the
borrowings upon expiry based on our actual business requirement. We relied on equity
financing as the major sources of liquidity during the Track Record Period.
During the Track Record Period, we incurred negative cash flows from our operations and
our operating cash outflows mainly resulted from our research and development costs. Our
operating activities used RMB202.1 million, RMB206.4 million, RMB136.9 million and
RMB34.0 million for the years ended December 31, 2023 and 2024 and four months ended
April 30, 2024 and 2025, respectively. We expect to generate more cash flow from our
operating activities, through income from launching and commercializing GFH925, forging
productive collaboration agreements with third parties, advancing the development and
eventually commercializing GFH925 overseas and other pipeline products, and enhancing our
cost containment capacity and operating efficiency. In order to bring to fruition our research
and development objectives, we will ultimately need additional funding sources and there can
be no assurances that they will be made available.
FINANCIAL INFORMATION
– 539 –


--- page 549 ---
Cash Flows
The following table sets forth key items of our consolidated statements of cash flows for
the periods indicated:
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
Operating activities
Cash used in operating
activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(211,792) (222,266) (140,384) (38,670)
Interest received /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11189,732 15,866 3,439 4,625
Net cash flows used in
operating activities /H1118/H1118/H1118/H1118/H1118/H1118(202,060) (206,400) (136,945) (34,045)
Investing activities
Purchases of items of
property, plant and
equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(594) (236) (5) (11)
Purchases for other intangible
assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (32) – –
Purchases of financial assets
at FVTPL /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(480,000) (170,000) (110,000) –
Withdrawal of financial assets
at FVTPL /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118744,024 170,402 90,222 –
Proceeds from disposal of
property, plant and
equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 344–
Proceeds from withdrawal of
time deposits with original
maturity of more than three
months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 124,560 16,290 33,151
Purchases of time deposits
with original maturity of
more than three months /H1118/H1118/H1118/H1118– (123,968) (119,227) –
Net cash flows from/(used
in) investing activities /H1118/H1118/H1118/H1118263,443 730 (122,716) 33,140
Financing activities
New bank borrowings /H1118/H1118/H1118/H1118/H1118/H1118/H11185,312 56,928 5,800 54,900
Repayment of bank
borrowings /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(22,767) (11,112) – (21,128)
Interest paid on bank
borrowings /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(119) (877) (52) (401)
FINANCIAL INFORMATION
– 540 –


--- page 550 ---
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
Principal portion of lease
payments /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5,402) (5,144) (1,627) (2,187)
Interest paid for lease
liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,366) (1,112) (389) (271)
Proceeds on issue of shares /H1118/H1118 – 207,871 207,871 –
Payment of listing expenses /H1118/H1118 – (1,276) – (2,731)
Issued costs paid /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(4,717) (11,840) (6,698) –
Net cash flows (used
in)/from financing
activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(29,059) 233,438 204,905 28,182
Net increase/(decrease) in
cash and cash equivalents /H1118/H1118 32,324 27,768 (54,756) 27,277
Cash and cash equivalents at
beginning of year/period /H1118/H1118/H1118295,321 332,197 332,197 362,125
Effects of foreign exchange
rate changes, net /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,552 2,160 585 1,364
Cash and cash equivalents at
end of year/period /H1118/H1118/H1118/H1118/H1118/H1118/H1118332,197 362,125 278,026 390,766
Operating Activities
In the four months ended April 30, 2025, our net cash used in operating activities was
RMB34.0 million, which was primarily attributable to our loss before tax of RMB66.6 million,
primarily adjusted for (i) fair value loss on redemption liabilities on equity shares of RMB50.7
million, (ii) decrease in trade and other payables of RMB21.5 million, (iii) decrease in
inventories of RMB4.7 million, (iv) decrease in contract liabilities of RMB29.9 million.
In 2024, our net cash used in operating activities was RMB206.4 million, which was
primarily attributable to our loss before tax of RMB677.6 million, primarily adjusted for (i) fair
value loss on redemption liabilities on equity shares of RMB382.6 million, (ii) increase in trade
and other payables of RMB148.6 million, (iii) decrease in contract liabilities of RMB59.7
million, (iv) share-based payment compensation of RMB26.9 million and (v) finance costs of
RMB18.0 million.
In 2023, our net cash used in operating activities was RMB202.1 million, which was
primarily attributable to our loss before tax of RMB508.3 million, primarily adjusted for (i) fair
value loss on redemption liabilities on equity shares of RMB257.0 million, (ii) share-based
payment compensation of RMB37.0 million, (iii) increase in trade receivables of RMB32.9
million and (iv) decrease in prepayments, other receivables and other assets of RMB14.7
million.
FINANCIAL INFORMATION
– 541 –


--- page 551 ---
We monitor and maintain a level of cash and cash equivalents deemed adequate to finance
our operations and mitigate the effects of fluctuations in cash flows. In view of our net
operating cash outflows throughout the Track Record Period, we plan to improve such position
by:
 rapidly advancing our pipeline products towards commercialization to generate
revenue from product sales. For our Core Product GFH925, we expect to generate
inflow of cash from the commercialization of GFH925 in China. We are conducting
and planning to conduct further clinical development of GFH925 in overseas
jurisdictions, such as in the United States and Europe to pave the way for launching
and commercializing GFH925 overseas to maximize its value. We also plan to
advance GFH375 clinical trial in China to further validate its clinical safety and
efficacy profiles. In addition to our Core Products, we have been optimizing our
product portfolio and propelling it from preclinical stage toward clinical studies. As
we achieve regulatory approvals for more pipeline products, we expect to generate
a steady inflow of cash from sales of pipeline products in the foreseeable future;
 entering into collaboration and licensing agreements with major pharmaceutical
companies for the co-development of our pipeline products, and activity pursuing
business development opportunities at every stage of the development of our
product candidates; and
 adopting comprehensive measures to effectively control our cost and operating
expenses. For example, we plan to continue to regularly evaluate our existing and
future arrangements and actively seek mutually beneficial strategic cooperations to
control our research and development costs.
Investing Activities
For the four months ended April 30, 2025, our net cash from investing activities was
RMB33.1 million, primarily as a result of proceeds from withdrawal of time deposits with
original maturity of more than three months of RMB33.2 million.
In 2024, our net cash generated from investing activities was RMB0.7 million, primarily
as a result of the offsetting effect of purchases and withdrawal of financial assets at FVTPL,
and purchases and proceeds from time deposits with original maturity of more than three
months.
In 2023, our net cash generated from investing activities was RMB263.4 million, which
was primarily attributable to disposal of financial assets at FVTPL of RMB744.0 million,
partially offset by purchases of financial assets at FVTPL of RMB480.0 million.
FINANCIAL INFORMATION
– 542 –


--- page 552 ---
Financing Activities
In the four months ended April 30, 2025, we had RMB28.2 million of net cash inflow
from financing activities, primarily attributable to the proceeds from new bank borrowings of
RMB54.9 million, offset by repayment of bank borrowings of RMB21.1 million.
In 2024, we had RMB233.4 million of net cash inflow from financing activities, primarily
attributable to the capital contributions from investors of RMB207.9 million in connection with
our series C+ equity financing round and proceeds from new bank borrowings of RMB56.9
million.
In 2023, we had RMB29.1 million of net cash outflow from financing activities, primarily
attributable to our repayment of bank borrowings of RMB22.8 million.
CASH OPERATING COSTS
The following table sets forth information on our cash operating costs for the periods
indicated.
Research and development costs
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(unaudited)
(RMB in thousands)
Research and development
costs for Core Products
– Clinical development
costs and termination fee /H1118 26,449 43,406 20,435 9,596
– staff costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,322 22,798 11,284 8,138
– CMC and Preclinical
development costs /H1118/H1118/H1118/H1118/H1118/H111870,976 58,082 25,088 20,069
Research and development
costs for other product
candidates
– Clinical development
costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111857,626 24,767 10,013 2,017
– staff costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111855,560 48,316 20,112 18,547
– CMC and Preclinical
development costs /H1118/H1118/H1118/H1118/H1118/H111831,562 43,808 11,030 3,839
Workforce employment
costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819,087 19,345 7,619 7,849
284,582 260,522 105,581 70,055
FINANCIAL INFORMATION
– 543 –


--- page 553 ---
WORKING CAPITAL CONFIRMATION
Our Directors are of the opinion that, taking into account the financial resources
available, including cash and cash equivalents, the expected income from commercialization of
GFH925 in China, and the estimated net proceeds from the Listing, as well as our cash burn
rate, we have sufficient working capital to cover at least 125% of our costs, including research
and development expenses and administrative expenses for at least the next 12 months from the
date of this Prospectus.
Our cash burn rate refers to the average monthly amount of net cash used in operating
activities, capital expenditures and lease payments. Assuming an average cash burn rate going
forward of 1.1 times the level in 2024, we estimate that our cash at bank and on hand and other
financial assets as of September 30, 2025 will be able to maintain our financial viability for 71
months from September 30, 2025 taking into account the estimated net proceeds from the
Global Offering; or we estimate that we will be able to maintain our financial viability for 13
months from September 30, 2025 without taking into account the estimated net proceeds from
the Global Offering. We will continue to monitor our cash flows from operations closely and
expect to raise our next round of financing, if needed, with a minimum buffer of 12 months.
INDEBTEDNESS
The following table sets forth the breakdown of our indebtedness as of the dates
indicated:
As of December 31,
As of
April 30,
As of
July 31,
2023 2024 2025 2025
(RMB in thousands)
(unaudited)
Current
Interest-bearing bank borrowings 5,312 51,128 85,117 74,209
Redemption liabilities on equity
shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,636,508 2,214,121 2,264,813 3,199,126
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,526 4,243 3,345 3,419
Non-current
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820,835 13,977 12,861 11,708
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,668,181 2,283,469 2,366,136 3,288,462
FINANCIAL INFORMATION
– 544 –


--- page 554 ---
As of December 31, 2023 and 2024, and April 30, 2025, except as discussed above, we
did not have any material mortgages, charges, debentures, loan capital, debt securities, loans,
bank overdrafts or other similar indebtedness, finance lease or hire purchase commitments,
liabilities under acceptances (other than normal trade bills), acceptance credits, which are
either guaranteed, unguaranteed, secured or unsecured, or guarantees or other contingent
liabilities. We utilize credit facilities for short-term liquidity management purpose, the interest
rate of which ranged from 2.5% to 3.0% during the Track Record Period. As of April 30, 2025,
we had RMB35.1 million of unutilized credit facilities. Since April 30, 2025, the latest
practicable date for the purpose of the indebtedness statement, and up to the date of this
Prospectus, there had been no material change in our indebtedness.
Our Directors confirm that as of the Latest Practicable Date, there was no material
covenant on any of our outstanding debt and there was no breach of any covenant during the
Track Record Period and up to the Latest Practicable Date. Our Directors further confirm that
our Group did not experience any difficulty in obtaining bank loans and other borrowings,
default in payment of bank loans and other borrowings or breach of covenants during the Track
Record Period and up to the Latest Practicable Date.
CAPITAL EXPENDITURES
The following table sets forth our capital expenditures for the periods indicated:
For the Y ear Ended
December 31,
For the Four Months Ended
April 30,
2023 2024 2024 2025
(RMB in thousands)
Purchase of property, plant
and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118594 236 5 11
Our historical capital expenditures during the Track Record Period primarily included
purchases of property, plant and equipment. We funded our capital expenditure requirements
during the Track Record Period mainly from equity financing. We plan to fund our planned
capital expenditures using our cash at bank and the net proceeds received from the Global
Offering. Please refer to the section headed “Use of Proceeds” in this prospectus for more
details. We may reallocate the fund to be utilized on capital expenditure based on our ongoing
business needs.
FINANCIAL INFORMATION
– 545 –


--- page 555 ---
CONTRACTUAL COMMITMENTS
We had the following contractual commitments as of the dates indicated:
As of December 31, As of April 30,
2023 2024 2025
RMB’000 RMB’000 RMB’000
Property, plant and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H111851–
CONTINGENT LIABILITIES
As of December 31, 2023 and 2024 and April 30, 2025, we did not have any contingent
liabilities. We confirm that as of the Latest Practicable Date, there had been no material
changes or arrangements to our contingent liabilities.
OFF-BALANCE SHEET COMMITMENTS AND ARRANGEMENTS
As of the Latest Practicable Date, we had not entered into any off-balance sheet
transactions.
RELATED PARTY TRANSACTIONS
During the Track Record Period, we had one transaction with a related party in
accordance with the terms agreed with the counterparty. Details of our transaction with the
related party during the Track Record Period are set out in Note 33 to the Accountants’ Report
included in Appendix I to this Prospectus. Our Directors confirm that the material related party
transaction during the Track Record Period was conducted on an arm’s length basis, and would
not distort our results of operations over the Track Record Period or make our historical results
over the Track Record Period not reflective of our expectations for our future performance.
KEY FINANCIAL RATIOS
The table below sets forth the current ratio of our Group as of the dates indicated:
As of December 31, As of April 30,
2023 2024 2025
Current ratio (1) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180.25 0.23 0.22
Note:
(1) Current ratio equals current assets divided by current liabilities as of the end of the year/period.
FINANCIAL INFORMATION
– 546 –


--- page 556 ---
MARKET RISK DISCLOSURE
We are exposed to a variety of financial risks, including foreign currency risk, credit risk
and liquidity risk, as set out below. We manage and monitor these risks to ensure that
appropriate measures can be implemented in a timely and effective manner. For further details,
see Note 36 to the Accountants’ report in Appendix I to this Prospectus. The discussion below
provides a summary of our market risks.
Foreign Currency Risk
Foreign currency risk means the risk relating to the fluctuation of fair value or future cash
flows of financial instruments, which arises from changes in exchange rates. We have
transactional currency exposures. Such exposures arise from financing activities by
subsidiaries in currencies other than the subsidiaries’ functional currencies. For further details,
including relevant sensitivity analysis, see Note 36 to the Accountants’ Report in Appendix I
to this Prospectus.
Credit Risk
Credit risk refers to the risk that a counterparty will default on its contractual obligations
resulting in a financial loss. Our credit risk is primarily attributable to trade and other
receivables. We trade only with recognized and creditworthy third parties. Management has a
credit policy in place and the exposure to credit risk is monitored on an ongoing basis. It is our
policy that all customers who wish to trade on credit terms are subject to credit verification
procedures. In addition, receivable balances are monitored on an ongoing basis and our
exposure to bad debts is not significant.
Our management has assessed that during the Track Record Period, trade receivables have
not had a significant increase in credit risk since initial recognition. Our management has
applied the simplified approach to provide for ECLs prescribed by IFRS 9, which permits the
use of the lifetime expected loss provision for all trade and other receivables. Our management
expects the occurrence of losses from non-performance by counterparties of trade and other
receivables to be remote and no loss allowance for impairment of trade and other receivables
is provided as of April 30, 2025.
Liquidity Risk
We monitor and maintain a level of cash and cash equivalents deemed adequate by our
management to finance the operations and mitigate the effects of fluctuations in cash flows. For
further details, see Note 36 to the Accountants’ Report set out in Appendix I to this Prospectus.
FINANCIAL INFORMATION
– 547 –


--- page 557 ---
DIVIDEND
We have never declared or paid any dividends on our ordinary shares or any other
securities. As of the Latest Practicable Date, we did not have a formal dividend policy. We
currently intend to retain all available funds and earnings, if any, to fund the development and
expansion of our business and we do not intend to declare or pay any dividends in the
foreseeable future. Investors should not purchase our ordinary shares with the expectation of
receiving cash dividends. Any future determination to pay dividends will be made at the
discretion of our Directors subject to our Articles of Association and the PRC Company Law,
and may be based on a number of factors, including our future operations and earnings, capital
requirements and surplus, general financial condition, contractual restrictions and other factors
that our Directors may deem relevant. No dividend shall be declared or payable except out of
our profits and reserves lawfully available for distribution. Regulations in the PRC currently
permit payment of dividends of a PRC company only out of accumulated distributable after-tax
profits as determined in accordance with its articles of association and the accounting standards
and regulations in China.
As confirmed by our PRC Legal Advisor, according to the PRC law, any future net profit
that we make will have to be first applied to make up for our historically accumulated losses,
after which we will be obliged to allocate 10% of our net profit to our statutory common
reserve fund until such fund has reached more than 50% of our registered capital. We will
therefore only be able to declare dividends after (i) all our historically accumulated losses have
been made up for; and (ii) we have allocated sufficient net profit to our statutory common
reserve fund as described above.
DISTRIBUTABLE RESERVES
As of April 30, 2025, our Company did not have any distributable reserves.
LISTING-RELATED EXPENSE INCURRED AND TO BE INCURRED
Our listing expenses represent professional fees, underwriting commissions and other
fees incurred in connection with the Global Offering. Based on an Offer Price of HK$20.39 per
H Share, we estimated that the total listing expenses for the Global Offering are approximately
HK$138.8 million, accounting for approximately 8.8% of the gross proceeds from the Global
Offering (assuming no H Shares are issued pursuant to the Offer Size Adjustment Option or the
Over-allotment Option), of which approximately HK$19.3 million is expected to be charged to
our consolidated statements of profit or loss and other comprehensive income upon the
completion of Global Offering, and approximately HK$89.2 million is expected to be
accounted for as a deduction from equity upon the completion of Global Offering. The above
expenses comprise of (i) underwriting-related expenses, including underwriting commission
and other expenses, of HK$72.9 million; and (ii) non-underwriting-related expenses of
HK$65.8 million, including (a) fee paid and payable to legal advisors and reporting
accountants of HK$32.1 million, and (b) other fees and expenses of HK$33.8 million. RMBnil,
RMB18.4 million and RMB9.3million of the listing expenses have been recognized in profit
or loss for the years ended December 31, 2023, 2024 and the four months ended April 30, 2025,
respectively. The listing expenses above are the latest practicable estimate for reference only,
and the actual amount may differ from this estimate.
FINANCIAL INFORMATION
– 548 –


--- page 558 ---
UNAUDITED PRO FORMA STATEMENT OF ADJUSTED NET TANGIBLE ASSETS
The following unaudited pro forma statement of adjusted consolidated net tangible assets
of the Group prepared in accordance with Rule 4.29 of the Listing Rules is set out below to
illustrate the effect of the Global Offering on the consolidated net tangible assets attributable
to equity shareholders of the Company as of April 30, 2025 as if the Global Offering had taken
place on April 30, 2025.
The unaudited pro forma statement of adjusted consolidated net tangible assets has been
prepared for illustrative purposes only and because of its hypothetical nature, it may not
provide a true picture of the financial position of the Group had the Global Offering been
completed as of April 30, 2025 or any future date.
Consolidated net
tangible liabilities
of the Group
attributable to
owners of the
parent as at
April 30, 2025
Estimated
net Proceeds
from the
Global
Offering
Estimated
impact to the
consolidated
net tangible
liabilities
upon the
derecognition
of redemption
liabilities on
equity shares
upon Listing
Unaudited
pro forma
adjusted
consolidated
net tangible
assets
attributable
to owners of
the parent
as at
April 30, 2025
Unaudited
pro forma adjusted
consolidated net
tangible assets per
Share attributable to
owners of the
parent as at
April 30, 2025
RMB’000 RMB’000 RMB’000 RMB’000 RMB HK$
(Note 1) (Note 2) (Note 3) (Note 4&5) (Note 6)
Based on an Offer
Price of HK$20.39
per Share /H1118/H1118/H1118/H1118/H1118/H1118/H1118(2,014,837) 1,343,833 2,264,813 1,593,809 4.62 5.06
Notes:
1. The consolidated net tangible liabilities of the Group attributable to equity holders of the Company as at April
30, 2025 is arrived at after deducting intangible assets or RMB1,198,000 from the audited net liabilities
attributable to owners of the parent as at April 30, 2025 of RMB2,013,639,000 set out in the Accountants’
Report in Appendix I to this Prospectus.
2. The estimated net proceeds from the Global Offering are based on the offer price of HK$20.39 per Share after
deduction of the underwriting fees and other related expenses payable by the Company (excluding the listing
expenses that have been charged to profit or loss during the Track Record Period) and do not take into account
any share which may be sold and offered upon exercise of the Offer Size Adjustment Option or the
Over-allotment Option.
3. Upon the Listing and the completion of the Global Offering, all redemption liabilities on equity shares will be
automatically derecognized. The redemption liabilities on equity shares will then be transferred from liabilities
to equity. Accordingly, for the purpose of the unaudited pro forma financial information, the unaudited pro
forma adjusted net tangible assets attributable to owners of the parent will be increased by RMB2,264,813,000,
being the carrying amounts of the redemption liabilities on equity shares as at April 30, 2025.
FINANCIAL INFORMATION
– 549 –


--- page 559 ---
4. The unaudited pro forma adjusted consolidated net tangible assets per Share is arrived at after adjustments
referred to in the preceding note 2 and 3 and on the basis that 345,340,630 Shares were in issue assuming the
Subdivision and the Global Offering has been completed on April 30, 2025.
5. For the purpose of this unaudited pro forma statement of adjusted net tangible assets, the balances stated in
RMB are converted into HK$ at the rate of RMB1.00 to HK$1.0967.
6. No other adjustment has been made to the unaudited pro forma adjusted consolidated net tangible assets to
reflect any trading results or other transactions of the Group entered into subsequent to April 30, 2025.
NO MATERIAL ADVERSE CHANGE
Our Directors confirm that, up to the date of this Prospectus, there has been no material
adverse change in our financial or trading position since April 30, 2025 (being the date on
which the latest consolidated financial information of our Group was prepared) and there has
been no event since April 30, 2025 which would materially affect the information shown in our
consolidated financial statements included in the Accountants’ Report in Appendix I to this
Prospectus.
DISCLOSURE UNDER RULES 13.13 TO 13.19 OF THE LISTING RULES
Our Directors confirm that, as of the Latest Practicable Date, there was no circumstance
that would give rise to a disclosure requirement under Rules 13.13 to 13.19 of the Listing
Rules.
FINANCIAL INFORMATION
– 550 –


--- page 560 ---
FUTURE PLANS
For further details of our future plans, please see the section headed “Business —
Strategies” in this Prospectus.
USE OF PROCEEDS
We estimate that the aggregate net proceeds to our Company from the Global Offering
will be approximately HK$1,443.6 million, after deducting underwriting fees and estimated
expenses in connection with the Global Offering payable by us and assuming that the Offer
Size Adjustment Option the Over-allotment Option are not exercised and based on an Offer
Price of HK$20.39 per H Share.
We intend to apply such net proceeds from the Global Offering for the following
purposes:
 approximately HK$1,024.9 million (or approximately 71.0% of the net proceeds) to
fund further development of our Core Products GFH925 and GFH375, which
includes:
 approximately HK$476.4 million (or approximately 33.0% of the net proceeds)
will be used to fund the clinical development of GFH925.
 approximately HK$259.8 million (or approximately 18.0% of the net
proceeds) will be used to fund the Phase III clinical trial to evaluate the
safety and efficacy of the GFH925/cetuximab combination therapy as a
first-line treatment for NSCLC harboring the KRAS G12C mutation,
which we plan to initiate in United States in the fourth quarter of 2025.
The planned Phase III clinical trial in the U.S. is designed to be part of
a multi-regional study in U.S. and EU, and may support future global
registration in multiple regions. In EU, we plan to conduct the Phase III
trial in Spain, Italy and Greece. We would also consider conducting the
Phase III trial in other EU member states where there are extensive
experience in conducting clinical trials and KRAS testing capacity for
lung cancers.
 approximately HK$216.5 million (or approximately 15.0% of the net
proceeds) will be used to fund other costs associated with the clinical
development of GFH925, including CMC and staff costs. To reduce the
production cost, we are actively developing a second-generation
manufacturing process for GGH925, which we expect to adopt in 2026.
Compared with the first-generation manufacturing process, the second-
generation manufacturing process is expected to generate products of the
same quality while achieving over 50% of cost reduction. We are taking
full responsibility for the entire process, including vendor selection.
FUTURE PLANS AND USE OF PROCEEDS
– 551 –


--- page 561 ---
The proceeds allocated for GFH925 is only in relation to our clinical trials in
ex-Greater China and the process development; they are not related to the our
collaboration or arrangement with Innovent.
We have incurred RMB81.5 million, RMB101.2 million, RMB73.3 million and
RMB13.9 million major items of research and development costs attributable
to GFH925 in 2023, 2024 and four months ended April 30, 2024 and 2025.
We anticipate completing the KROCUS Phase II trial in the fourth quarter of
2025. We plan to leverage the clinical results of the KROCUS trial to apply for
a Phase III clinical trial in the United States to evaluate the safety and efficacy
of the GFH925/cetuximab combination therapy as a first-line treatment for
NSCLC harboring the KRAS G12C mutation.
For further details, please see the section headed “Business — Our RAS Matrix
Pipeline Products — Core Product GFH925: A Small Molecule Inhibitor of
KRAS G12C — Clinical Development Plan” in this Prospectus.
 approximately HK$548.6 million (or approximately 38.0% of the net proceeds)
will be used to fund the clinical development of GFH375 in China.
 approximately HK$173.2 million (or approximately 12.0% of the net
proceeds) will be used to fund the Phase II part of the Phase I/II clinical
trial of GFH375 in patients with advanced solid tumors harboring the
KRAS G12D mutation, which we initiated in China in February 2025.
 approximately HK$28.9 million (or approximately 2.0% of the net
proceeds) will be used to fund the planned GFH375X1201 study, which
is a separate Phase II clinical trial of GFH375 in patients with metastatic
PDAC harboring the KRAS G12D mutation. The purpose of initiating the
GFH375X1201 study is to evaluate GFH375 as a potential treatment for
PDAC, the lead indication of GFH375.
 approximately HK$274.3 million (or approximately 19.0% of the net
proceeds) will be used to fund the planned Phase III clinical trial of
GFH375 in patients with advanced solid tumors (expected to include
PDAC, NSCLC and CRC) harboring the KRAS G12D mutation.
 approximately HK$72.2 million (or approximately 5.0% of the net
proceeds) will be used to fund other costs associated with the clinical
development of GFH375, including CMC and staff costs. We expect our
GFH375 once entering into commercialization stage will require the use
of our in-house manufacturing facility under construction in Zhejiang
Province, which has a designed annual capacity of 100 million tablets.
We have incurred RMB39.7 million, RMB42.1 million, RMB4.8 million and
RMB13.3 million major items of research and development costs attributable
to GFH375 in 2023, 2024 and four months ended April 30, 2024 and 2025.
FUTURE PLANS AND USE OF PROCEEDS
– 552 –


--- page 562 ---
We have initiated the Phase II part of the Phase I/II clinical trial in patients
with advanced solid tumors harboring the KRAS G12D mutation in China in
February 2025. We expect to submit to the NMPA a pre-pivotal study
communication request in the third quarter of 2025 and initiate a pivotal
clinical study of GFH375 as a treatment of PDAC in the fourth quarter of 2025.
For further details, please see the section headed “Business — Our RAS Matrix
Pipeline Products — GFH375: A Small Molecule Inhibitor of KRAS G12D —
Clinical Development Plan” in this Prospectus.
 approximately HK$274.3 million (or approximately 19.0% of the net proceeds) to
fund the development of our other product candidates such as GFH312, GFS202A,
GFH276, GFS784 and other preclinical candidates. In particular, approximately
HK$101.0 million, representing around 7.0% of the net proceeds, is expected to be
allocated to fund the clinical and regulatory costs associated with the Phase II and
Phase III trials of GFH312 as monotherapy for PBC in China. For further details,
please see the section headed “Business — Other Pipeline Products” in this
Prospectus; and
We submitted an IND application for a Phase II clinical trial of GFH312 for the
treatment of PBC to the NMPA in March 2025 and obtained NMPA ’s approval in
May 2025. We plan to initiate a Phase II clinical trial of GFH312 for the treatment
of PBC in the first half of 2026.
 approximately HK$144.4 million (or approximately 10% of the net proceeds) will be
used for our working capital and other general corporate purposes.
The net proceeds from the Global Offering will not be used to finance the outstanding
payment of the Supplementary Agreement with Innovent or any potential patent disputes.
If the Offer Size Adjustment Option and the Over-allotment Option are exercised in full,
the net proceeds of the Global Offering would increase to approximately HK$1,668.5 million
(based on the Offer Price of HK$20.39 per H Share). We intend to apply the additional net
proceeds to the above uses in the proportion stated above.
To the extent that our net proceeds are not sufficient to fund the purposes set out above,
we intend to fund the balance through a variety of means, including cash generated from
operations, bank loans and other borrowings.
If the net proceeds of the Global Offering are not immediately applied to the above
purposes, we will only deposit those net proceeds into short-term interest-bearing accounts at
licensed commercial banks and/or other authorized financial institutions (as defined under the
SFO or the applicable laws and regulations in other jurisdictions) so long as it is deemed to be
in the best interests of our Company. We will issue an appropriate announcement if there is any
material change to the above proposed use of proceeds.
FUTURE PLANS AND USE OF PROCEEDS
– 553 –


--- page 563 ---
HONG KONG UNDERWRITERS
CLSA Limited
BOCOM International Securities Limited
Fosun International Securities Limited
ABCI Securities Company Limited
China Renaissance Securities (Hong Kong) Limited
CCB International Capital Limited
GF Securities (Hong Kong) Brokerage Limited
UNDERWRITING
This Prospectus is published solely in connection with the Hong Kong Public Offering.
The Hong Kong Public Offering is fully underwritten by the Hong Kong Underwriters on a
conditional basis. The International Offering is expected to be fully underwritten by the
International Underwriters.
The Global Offering comprises the Hong Kong Public Offering of initially 7,760,000
Hong Kong Offer Shares and the International Offering of initially 69,840,000 International
Offer Shares, subject, in each case, to reallocation on the basis as described in “Structure of
the Global Offering” as well as to the Offer Size Adjustment Option and the Over-allotment
Option (in the case of the International Offering).
UNDERWRITING ARRANGEMENTS AND EXPENSES
Hong Kong Public Offering
Hong Kong Underwriting Agreement
Pursuant to the Hong Kong Underwriting Agreement, our Company is offering the Hong
Kong Offer Shares for subscription by the public in Hong Kong on the terms and conditions
set out in this Prospectus and the Hong Kong Underwriting Agreement at the Offer Price.
Subject to (a) the Listing Committee granting approval for the listing of, and permission
to deal in, the H Shares to be issued pursuant to the Global Offering (including any additional
H Shares that may be issued pursuant to the exercise of the Offer Size Adjustment Option and
the Over-allotment Option) on the Main Board of the Stock Exchange, and such approval and
permission not subsequently having been withdrawn or revoked prior to the commencement of
dealings in the H Shares on the Stock Exchange and (b) certain other conditions set out in the
Hong Kong Underwriting Agreement, the Hong Kong Underwriters have agreed severally but
not jointly to procure subscribers for, or themselves to subscribe for, their respective applicable
proportions of the Hong Kong Offer Shares being offered which are not taken up under the
Hong Kong Public Offering on the terms and conditions set out in this Prospectus and the Hong
Kong Underwriting Agreement.
The Hong Kong Underwriting Agreement is conditional on, among other things, the
International Underwriting Agreement having been executed and becoming unconditional and
not having been terminated in accordance with its terms.
UNDERWRITING
– 554 –


--- page 564 ---
Grounds for Termination
The obligations of the Hong Kong Underwriters to subscribe or procure subscribers for
the Hong Kong Offer Shares under the Hong Kong Underwriting Agreement are subject to
termination. If at any time prior to 8:00 a.m. on the day that trading in the H Shares commences
on the Stock Exchange:
(a) there develops, occurs, exists or comes into force:
(i) any new law or regulation or any change or development involving a
prospective change or any event or series of events or circumstances likely to
result in a change or a development involving a prospective change in existing
laws or regulations, or the interpretation or application thereof by any court or
any competent authority in or affecting Hong Kong, PRC, the United States,
Australia, the British Virgin Islands, the United Kingdom, the European Union
(or any member thereof), or other jurisdictions relevant to the Group or the
Global Offering (each a “ Relevant Jurisdiction ” and collectively, the
“Relevant Jurisdictions ”); or
(ii) any change or development involving a prospective change, or any event or
series of events or circumstances likely to result in a change or prospective
change, in any local, national, regional or international financial, political,
military, industrial, economic, fiscal, legal, regulatory, currency, credit or
market conditions or sentiments, taxation, equity securities or currency
exchange rate or controls or any monetary or trading settlement system, or
foreign investment regulations (including, without limitation, a devaluation of
the Hong Kong dollar, U.S. dollar or Renminbi against any foreign currencies,
a change in the system under which the value of the Hong Kong dollar is linked
to that of the U.S. dollar or the Renminbi is linked to any foreign currency or
currencies) or other financial markets (including, without limitation,
conditions and sentiments in stock and bond markets, money and foreign
exchange markets, the inter-bank markets and credit markets) in or affecting
any Relevant Jurisdictions, or affecting an investment in the Offer Shares; or
(iii) any event or series of events, or circumstances in the nature of force majeure
(including, without limitation, any acts of government, declaration of a
regional, national or international emergency or war, calamity, crisis, economic
sanctions, strikes, labor disputes, other industrial actions, lock-outs, fire,
explosion, flooding, tsunami, earthquake, volcanic eruption, civil commotion,
riots, rebellion, public disorder, paralysis in government operations, acts of
war, epidemic, pandemic, outbreak or escalation, mutation or aggravation of
diseases, accident or interruption or delay in transportation, local, national,
UNDERWRITING
– 555 –


--- page 565 ---
regional or international outbreak or escalation of hostilities (whether or not
war is or has been declared), act of God or act of terrorism (whether or not
responsibility has been claimed)) in or affecting any of the Relevant
Jurisdictions; or
(iv) the imposition or declaration of any moratorium, suspension or limitation
(including without limitation, any imposition of or requirement for any
minimum or maximum price limit or price range) on (i) the trading in shares
or securities generally on the Stock Exchange, the Shanghai Stock Exchange,
the Shenzhen Stock Exchange, the New Y ork Stock Exchange, the NASDAQ
Global Market or the London Stock Exchange; or (ii) the trading in any
securities of the Company listed or quoted on a stock exchange or an
over-the-counter market; or
(v) the imposition or declaration of any general moratorium on banking activities
in or affecting any of the Relevant Jurisdictions or any disruption in
commercial banking or foreign exchange trading or securities settlement or
clearing services, procedures or matters in or affecting any of the Relevant
Jurisdictions; or
(vi) any change or prospective change, or a materialization of, any of the risks set
out in the section headed “Risk Factors” in this Prospectus; or
(vii) any breach of any of the obligations or undertakings imposed upon the
Company, Dr. Lu or Dr. Lan or any cornerstone investor (as applicable) to the
Hong Kong Underwriting Agreement, the International Underwriting
Agreement or the cornerstone investment agreements, or
(viii) the commencement by any authority or other regulatory or political body or
organization of any public action or investigation against a member of the
Group or a director or a supervisor or a senior management member of the
Company or announcing an intention to take any such action; or
(ix) any valid demand by creditors for payment or repayment of indebtedness of
any member of the Group or in respect of which any member of the Group is
liable prior to its stated maturity; or
(x) any non-compliance of this Prospectus, the CSRC Filings (as defined in the
Hong Kong Underwriting Agreement) or any aspect of the Global Offering
with the Listing Rules or any other applicable laws; or
(xi) any litigation, dispute, legal action or claim or regulatory or administrative
investigation or action being threatened, instigated or announced against any
member of the Group or Dr. Lu or Dr. Lan or any Director or any Supervisor
or senior management members as named in this Prospectus; or
UNDERWRITING
– 556 –


--- page 566 ---
(xii) any contravention by any member of the Group or any Director or any
Supervisor or any member of the senior management of the Company of any
applicable laws, including the Listing Rules, the Companies Ordinance, the
Companies (Winding Up and Miscellaneous Provisions) Ordinance and the
PRC Company Law,
which, in any such case individually or in the aggregate, in the sole and absolute
opinion of the Sole Sponsor and the Sole Sponsor Overall-Coordinator (for itself and
on behalf of the Overall Coordinators and the Hong Kong Underwriters):
(1) has or will or may have a material adverse effect, whether directly or indirectly,
on the assets, liabilities, business, general affairs, management, prospects,
shareholders’ equity, profits, losses, results of operations, position or
condition, financial or otherwise, or performance of the Company or the Group
as a whole;
(2) has or will or may have a material adverse effect on the success of the Global
Offering or the level of applications under the Hong Kong Public Offering or
the level of indications of interest under the International Offering; or
(3) makes or will make or may make it impracticable, inadvisable, inexpedient or
incapable for any material part of the Hong Kong Underwriting Agreement, the
Hong Kong Public Offering or the Global Offering to be performed or
implemented as envisaged, or for the Hong Kong Public Offering and/or the
Global Offering to proceed, or to market the Global Offering or the delivery or
distribution of the Offer Shares on the terms and in the manner contemplated
by the Offering Documents; or
(4) has or will or may have the effect of making any part of the Hong Kong
Underwriting Agreement (including underwriting) incapable of performance in
accordance with its terms or preventing the processing of applications and/or
payments pursuant to the Global Offering or pursuant to the underwriting
thereof; or
(b) there has come to the notice of the Sole Sponsor and the Sole Sponsor Overall-
Coordinator (for itself and on behalf of the Overall Coordinators and the Hong Kong
Underwriters) that:
(i) any statement contained in any of the Offering Documents (as defined in the
Hong Kong Underwriting Agreement), the CSRC Filings and/or any notices,
announcements, advertisements, communications or other documents issued or
used by or on behalf of the Company in connection with the Hong Kong Public
Offering (including any supplement or amendment thereto) (the “ Global
Offering Documents ”) was, when it was issued, or has become untrue,
incorrect, inaccurate in any material respect or misleading; or that any
estimate, forecast, expression of opinion, intention or expectation contained in
any such documents, was, when it was issued, or has become unfair or
misleading in any respect or based on untrue, dishonest or unreasonable
assumptions or given in bad faith; or
UNDERWRITING
– 557 –


--- page 567 ---
(ii) any matter has arisen or has been discovered which would, had it arisen or been
discovered immediately before the date of this Prospectus, constitute a material
omission or misstatement in any Global Offering Document; or
(iii) any breach of, or any event or circumstance rendering untrue or incorrect or
misleading in any respect, any of the representations, warranties and
undertakings given by the Company or Dr. Lu or Dr. Lan in the Hong Kong
Underwriting Agreement or the International Underwriting Agreement; or
(iv) any event, act or omission which gives rise or is likely to give rise to any
liability of any of the indemnifying parties pursuant to the indemnities in the
Hong Kong Underwriting Agreement; or
(v) there is any change or development involving a prospective change,
constituting or having a material adverse effect; or
(vi) the Chairman of the Board, any Director or any member of senior management
of the Company named in this Prospectus seeks to retire, or is removed from
office or vacating his/her office; or
(vii) any Director or any member of senior management of the Company named in
this Prospectus is being charged with an indictable offence or prohibited by
operation of law or otherwise disqualified from taking part in the management
or taking directorship of a company; or
(viii) the Company withdraws this Prospectus (and/or any other documents used in
connection with the subscription or sale of any of the Offer Shares pursuant to
the Global Offering) or the Global Offering; or
(ix) the approval by the Listing Committee of the listing of, and permission to deal
in, the H Shares in issue and to be issued pursuant to the Global Offering
(including any additional H Shares that may be issued pursuant to the exercise
of the Offer Size Adjustment Option and the Over-allotment Option) is refused
or not granted, other than subject to customary conditions, on or before the
Listing Date, or if granted, the approval is subsequently withdrawn, cancelled,
qualified (other than by customary conditions), revoked or withheld; or
(x) any expert (as named in this Prospectus) has withdrawn its consent to the issue
of this Prospectus with the inclusion of its reports, letters and/or legal opinions
(as the case may be) and references to its name included in the form and
context in which it respectively appears; or
(xi) any prohibition on the Company for whatever reason from offering, allotting,
issuing or selling any of the Offer Shares pursuant to the terms of the Global
Offering; or
UNDERWRITING
– 558 –


--- page 568 ---
(xii) any person has withdrawn or sought to withdraw its consent to being named in
any of the Offering Documents or to the issue of any of the Offering
Documents; or
(xiii) an order or petition is presented for the winding-up or liquidation of any
member of the Group, or any member of the Group makes any composition or
arrangement with its creditors or enters into a scheme of arrangement or any
resolution is passed for the winding-up of any member of the Group or a
provisional liquidator, receiver or manager is appointed over all or part of the
assets or undertaking of any member of the Group or anything analogous
thereto occurs in respect of any member of the Group; or
(xiv) (A) the notice of acceptance of the CSRC Filings issued by the CSRC and/or
the results of the CSRC Filings published on the website of the CSRC is
rejected, withdrawn, revoked or invalidated; or (B) other than with the prior
written consent of the Sole Sponsor Overall-Coordinator, the issue or
requirement to issue by the Company of a supplement or amendment to the
CSRC Filings pursuant to the CSRC Rules (as defined in the Hong Kong
Underwriting Agreement) or upon any requirement or request of the CSRC; or
(C) any non-compliance of the CSRC Filings with the CSRC Rules or any other
applicable laws; or
(xv) the issue or requirement to issue by the Company of a supplement or
amendment to this Prospectus or other documents in connection with the offer
and sale of the Offer Shares pursuant to the Companies (Winding Up and
Miscellaneous Provisions) Ordinance or the Listing Rules or upon any
requirement or request of the Stock Exchange and/or the SFC; or
(xvi) the imposition of sanctions or export controls in whatever form, directly or
indirectly, on any member of the Group or Dr. Lu or Dr. Lan or by or on any
Relevant Jurisdiction, or the withdrawal of trading privileges which existed on
the date of the Hong Kong Underwriting Agreement, in whatever form, directly
or indirectly, by, or for, any Relevant Jurisdiction; or
(xvii) that (i) a material portion of the orders placed or confirmed in the bookbuilding
process or (ii) any investment commitment made by any cornerstone investors
under the cornerstone investment agreements signed with such cornerstone
investors, have been withdrawn, terminated or cancelled, as a result of the
payment of the relevant investment amount not being received or settled in the
stipulated time and manner or otherwise,
then, in each case, the Sole Sponsor and the Sole Sponsor Overall-Coordinator (for
itself and on behalf of the Hong Kong Underwriters) may, in its sole and absolute
discretion and upon giving notice in writing to the Company, terminate the Hong
Kong Underwriting Agreement with immediate effect.
UNDERWRITING
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--- page 569 ---
Undertakings to the Stock Exchange Pursuant to the Listing Rules
Undertakings by Our Company
Pursuant to Rule 10.08 of the Listing Rules, our Company has undertaken to the Stock
Exchange that it will not issue any further Shares or securities convertible into equity securities
of our Company (whether or not of a class already listed) or enter into any agreement to such
an issue within six months from the Listing Date (whether or not such issue of Shares or
securities will be completed within six months from the Listing Date), except (a) pursuant to
the Global Offering (including pursuant to the Offer Size Adjustment Option and the
Over-allotment Option) or (b) under any of the circumstances provided under Rule 10.08 of the
Listing Rules.
Undertakings Pursuant to the Hong Kong Underwriting Agreement
Undertakings by Our Company and the Warranting Shareholders in Respect of Our Company
Our Company has undertaken to each of the Sole Sponsor, the Sole Sponsor-Overall
Coordinator, the Overall Coordinators, the Joint Global Coordinators, the Capital Market
Intermediaries, the Joint Bookrunners, the Joint Lead Managers and the Hong Kong
Underwriters that, except pursuant to the Global Offering (including pursuant to the Offer Size
Adjustment Option and the Over-allotment Option), at any time after the date of the Hong
Kong Underwriting Agreement up to and including the date falling six months after the Listing
Date (the “ First Six Month Period ”), it will not, without the prior written consent of the Sole
Sponsor and the Sole Sponsor-Overall Coordinator (for itself and on behalf of the Overall
Coordinators and the Hong Kong Underwriters) and unless in compliance with the
requirements of the Listing Rules:
(a) allot, issue, sell, accept subscription for, offer to allot, issue or sell, contract or agree
to allot, issue or sell, assign, mortgage, charge, pledge, hypothecate, lend, grant or
sell any option, warrant, contract or right to subscribe for or purchase, grant or
purchase any option, warrant, contract or right to allot, issue or sell, or otherwise
transfer or dispose of or create an encumbrance over, or agree to transfer or dispose
of or create an encumbrance over, either directly or indirectly, conditionally or
unconditionally, or repurchase, any legal or beneficial interest in the share capital or
any other securities of the Company or any interest in any of the foregoing
(including, without limitation, any securities convertible into or exchangeable or
exercisable for or that represent the right to receive, or any warrants or other rights
to purchase any share capital or other securities of the Company, as applicable), or
deposit any share capital or other securities of the Company, as applicable, with a
depositary in connection with the issue of depositary receipts; or
(b) enter into any swap or other arrangement that transfers to another, in whole or in
part, any of the economic consequences of ownership (legal or beneficial) of the
Shares or any other securities of the Company, or any interest in any of the foregoing
(including, without limitation, any securities convertible into or exchangeable or
exercisable for or that represent the right to receive, or any warrants or other rights
to purchase, any Shares); or
UNDERWRITING
– 560 –


--- page 570 ---
(c) enter into any transaction with the same economic effect as any transaction
described in paragraph (a) or (b) above; or
(d) offer to or agree to do any of the foregoing specified in paragraph (a), (b) or (c) or
announce any intention to do so,
in each case, whether any of the foregoing transactions is to be settled by delivery of share
capital or such other securities, in cash or otherwise (whether or not the issue of such
share capital or other securities will be completed within the First Six Month Period). The
Company further agrees that, in the event the Company is allowed to enter into any of the
transactions described in paragraph (a), (b) or (c) above or offers to or agrees to or
announces any intention to effect any such transaction during the period of six months
commencing on the date on which the First Six Month Period expires (the “ Second Six
Month Period ”), it will take all reasonable steps to ensure that such an issue or disposal
will not, and no other act of the Company will, create a disorderly or false market for any
Shares or other securities of the Company.
Dr. Lu and Dr. Lan (together, the “ Warranting Shareholders ”) undertake to each of the
Sole Sponsor, the Sole Sponsor-Overall Coordinator, the Overall Coordinators, the Joint Global
Coordinators, the Capital Market Intermediaries, the Joint Bookrunners, the Joint Lead
Managers and the Hong Kong Underwriters to procure the Company to comply with the above
undertakings.
Our Company has undertaken to each of the Sole Sponsor, the Sole Sponsor-Overall
Coordinator, the Overall Coordinators, the Joint Global Coordinators, the Capital Market
Intermediaries, the Joint Bookrunners, the Joint Lead Managers and the Hong Kong
Underwriters that:
(a) it will, and the Warranting Shareholders undertake to procure that the Company will,
comply with the minimum public float requirements specified in the Listing Rules
(the “ Minimum Public Float Requirement ”), and it will not effect any purchase of
the Shares, or agree to do so, which may reduce the holdings of the H Shares held
by the public (as defined in Rule 8.24 of the Listing Rules) to below the Minimum
Public Float Requirement or any waiver granted and not revoked by the Stock
Exchange prior to the expiration of the Second Six Month Period without first
having obtained the prior written consent of the Sole Sponsor and the Sole
Sponsor-Overall Coordinator (for itself and on behalf of the Overall Coordinators
and the Hong Kong Underwriters); and
(b) it will not, and the Warranting Shareholders undertake to procure that the Company
will not, enter into any agreement, arrangement or transaction which shall cause or
have the effect of causing the portion of the H Shares that are held by the public and
that are available for trading and not subject to any disposal restrictions (whether
under contract, the Listing Rules, applicable Laws or otherwise) on the Listing Date
to fall below the prescribed level under 19A.13C of the Listing Rules.
UNDERWRITING
– 561 –


--- page 571 ---
Undertakings by the Warranting Shareholders in Respect of Themselves
Each of the Warranting Shareholders has undertaken to each of the Company, the Sole
Sponsor, the Sole Sponsor-Overall Coordinator, the Overall Coordinators, the Joint Global
Coordinators, the Capital Market Intermediaries, the Joint Bookrunners, the Joint Lead
Managers and the Hong Kong Underwriters that, without the prior written consent of the Sole
Sponsor and the Sole Sponsor-Overall Coordinator (for itself and on behalf of the Overall
Coordinators and the Hong Kong Underwriters) and unless in compliance with the
requirements of the Listing Rules:
(a) he will not, and will procure that the relevant registered holder(s), any nominee or
trustee holding on trust for him and the companies controlled by him will not, at any
time during the First Six Month Period:
(i) sell, offer to sell, accept subscription for, contract or agree to allot, issue or
sell, mortgage, charge, pledge, hypothecate, lend, grant or sell any option,
warrant, contract or right to purchase, grant or purchase any option, warrant,
contract or right to sell, or otherwise transfer or dispose of or create an
encumbrance over, or agree to transfer or dispose of or create an encumbrance
over, either directly or indirectly, conditionally or unconditionally, any Shares
or other securities of the Company or any interest therein (including, without
limitation, any securities convertible into or exchangeable or exercisable for or
that represent the right to receive, or any warrants or other rights to purchase,
any Shares or any such other securities, as applicable or any interest in any of
the foregoing), or deposit any Shares or other securities of the Company with
a depositary in connection with the issue of depositary receipts; or
(ii) enter into any swap or other arrangement that transfers to another, in whole or
in part, any of the economic consequences of ownership (legal or beneficial)
of any Shares or other securities of the Company or any interest therein
(including, without limitation, any securities convertible into or exchangeable
or exercisable for or that represent the right to receive, or any warrants or other
rights to purchase, any Shares or any such other securities, as applicable or any
interest in any of the foregoing); or
(iii) enter into any transaction with the same economic effect as any transaction
specified in paragraph (i) or (ii) above; or
(iv) offer to or agree to or announce any intention to effect any transaction
specified in paragraph (i), (ii) or (iii) above,
in each case, whether any of the transactions specified in paragraph (i), (ii) or (iii)
above is to be settled by delivery of Shares or other securities of the Company or
in cash or otherwise, and whether or not the transactions will be completed within
the First Six Month Period; and
UNDERWRITING
– 562 –


--- page 572 ---
(b) until the expiry of the Second Six Month Period, in the event that he enters into any
of the transactions specified in paragraph (a)(i), (ii) or (iii) or offer to or agrees to
or contract to or publicly announce any intention to effect any such transaction, he
will take all reasonable steps to ensure that such a disposal will not create a
disorderly or false market in the securities of the Company.
The foregoing restrictions shall not prevent the Warranting Shareholders from (i)
purchasing additional Shares or other securities of the Company and disposing of such
additional Shares or securities of the Company in accordance with the Listing Rules, provided
that any such purchase or disposal does not contravene the foregoing lock-up arrangements
with the Warranting Shareholders or the compliance by the Company with the Minimum Public
Float Requirement, and (ii) using the Shares or other securities of the Company or any interest
therein beneficially owned by them as security (including a charge or a pledge) in favor of an
authorized institution (as defined in the Banking Ordinance (Chapter 155 of the Laws of Hong
Kong)) for a bona fide commercial loan, provided that:
(a) the relevant Warranting Shareholder will immediately inform the Company and the
Sole Sponsor-Overall Coordinator in writing of such pledge or charge together with
the number of Shares or other securities of the Company so pledged or charged if
and when he or the relevant registered holder(s) pledges or charges any Shares or
other securities of the Company beneficially owned by him; and
(b) when the relevant Warranting Shareholder receives indications, either verbal or
written, from the pledgee or chargee of any Shares that any of the pledged or
charged Shares or other securities of the Company will be disposed of, he will
immediately inform the Company and the Sole Sponsor-Overall Coordinator of such
indications.
Hong Kong Underwriters’ Interests in Our Company
Save for their respective obligations under the Hong Kong Underwriting Agreement, as
of the Latest Practicable Date none of the Hong Kong Underwriters was interested, legally or
beneficially, directly or indirectly, in any Shares or any securities of any member of our Group
or had any right or option (whether legally enforceable or not) to subscribe for or purchase, or
to nominate persons to subscribe for or purchase, any Shares or any securities of any member
of our Group.
Following the completion of the Global Offering, the Hong Kong Underwriters and their
affiliated companies may hold a certain portion of the H Shares as a result of fulfilling their
respective obligations under the Hong Kong Underwriting Agreement.
UNDERWRITING
– 563 –


--- page 573 ---
International Offering
International Underwriting Agreement
In connection with the International Offering, it is expected that our Company and the
Single Largest Shareholders will enter into the International Underwriting Agreement with,
among others, the Sole Sponsor, the Sole Sponsor-Overall Coordinator, the Overall
Coordinators, the Joint Global Coordinators, the Joint Bookrunners, the Joint Lead Managers,
the International Underwriters and the Capital Market Intermediaries on or about September
17, 2025. Under the International Underwriting Agreement and subject to the Offer Size
Adjustment Option and the Over-allotment Option, the International Underwriters would,
subject to certain conditions set out therein, agree severally but not jointly to procure
subscribers for, or themselves to subscribe for, their respective applicable proportions of the
International Offer Shares being offered under the International Offering.
It is expected that the International Underwriting Agreement may be terminated on
similar grounds as the Hong Kong Underwriting Agreement. Potential investors should note
that in the event that the International Underwriting Agreement is not entered into or is
terminated, the Global Offering will not proceed. See “Structure of the Global Offering — The
International Offering.”
Offer Size Adjustment Option
Our Company is expected to grant an Offer Size Adjustment Option under the
International Underwriting Agreement to the International Underwriters, exercisable by the
Sole Sponsor-Overall Coordinator (for itself and on behalf of other Overall Coordinators and
the International Underwriters) on or before the second business day prior to the Listing Date,
pursuant to which our Company may be required to allot and issue up to an aggregate of
11,640,000 additional Shares (representing approximately 15% of the number of Offer Shares
initially available under the Global Offering) at the Offer Price. The Offer Size Adjustment
Option provides flexibility for the Sole Sponsor-Overall Coordinator (for itself and on behalf
of other Overall Coordinators and the International Underwriters) to increase the number of
Offer Shares available for purchase under the International Offering to cover additional market
demand. See “Structure of the Global Offering — Offer Size Adjustment Option.”
UNDERWRITING
– 564 –


--- page 574 ---
Over-allotment Option
Our Company is expected to grant the Over-allotment Option to the International
Underwriters, exercisable by the Sole Sponsor-Overall Coordinator (for itself and on behalf of
other Overall-Coordinators and the International Underwriters) at any time from the Listing
Date until 30 days after the last day for lodging applications under the Hong Kong Public
Offering, being Thursday, October 16, 2025, pursuant to which our Company may be required
to issue up to an aggregate of 11,640,000 additional H Shares (representing not more than 15%
of the Offer Shares initially available under the Global Offering assuming the Offer Size
Adjustment Option is not exercised at all) or up to an aggregate of 13,386,000 additional H
Shares (representing not more than 15% of the Offer Shares initially available under the Global
Offering assuming the Offer Size Adjustment Option is exercised in full), in each case, taking
into account the Share Subdivision at the Offer Price to, among other things, cover
over-allocations in the International Offering, if any. See “Structure of the Global Offering —
Over-allotment Option.”
Commissions and Expenses
The Underwriters and the Capital Market Intermediaries will receive an underwriting
commission of 3.5% of the aggregate Offer Price of all the Offer Shares (including any Offer
Shares to be issued pursuant to the Offer Size Adjustment Option and the Over-allotment
Option) (the “ Fixed Fees ”). Our Company may, at its discretion, pay to one or more
Underwriter(s) and Capital Market Intermediary(ies) an additional discretionary fee of up to
1% of the aggregate Offer Price of all the Offer Shares (including any Offer Shares to be issued
pursuant to the Offer Size Adjustment Option and the Over-allotment Option) (the
“Discretionary Fees ”). For the purpose of disclosure of the ratio of fixed and discretionary
fees payable (the “ Fee Split Ratio ”) as required under paragraph 3B of Appendix D1A to the
Listing Rules, the Fee Split Ratio is approximately 77.78%:22.22%, assuming the
Discretionary Fees will be paid in full and regardless whether the Offer Size Adjustment
Option and the Over-allotment Option will be exercised or not.
For any unsubscribed Hong Kong Offer Shares reallocated to the International Offering,
our Company will pay an underwriting commission at the rate applicable to the International
Offering to the relevant International Underwriters (and not the Hong Kong Underwriters).
The Sole Sponsor is entitled to a sponsor fee in the amount of US$500,000. The aggregate
underwriting commissions and fees payable to the Underwriters and the Capital Market
Intermediaries, together with the Stock Exchange listing fees, the SFC transaction levy, the
AFRC transaction levy and the Stock Exchange trading fee, legal and other professional fees
and printing and other expenses payable by our Company in relation to the Global Offering are
estimated to be approximately HK$138.75 million (assuming an Offer Price of HK$20.39 per
H Share, the full payment of the Discretionary Fees, and the Offer Size Adjustment Option and
the Over-allotment Option are not exercised).
UNDERWRITING
– 565 –


--- page 575 ---
Indemnity
Each of our Company and the Single Largest Shareholders has agreed to jointly and
severally indemnify the Sole Sponsor, the Sole Sponsor-Overall Coordinator, the Overall
Coordinators, the Joint Global Coordinators, the Joint Bookrunners, the Joint Lead Managers,
the Hong Kong Underwriters, the Capital Market Intermediaries and each of them for certain
losses which they may suffer or incur, including losses arising from the performance of their
obligations under the Hong Kong Underwriting Agreement or any breach by any of our
Company and the Single Largest Shareholders of the Hong Kong Underwriting Agreement.
ACTIVITIES BY SYNDICATE MEMBERS
The underwriters of the Hong Kong Public Offering and the International Offering
(together, the “ Syndicate Members ”) and their affiliates may each individually undertake a
variety of activities (as further described below) which do not form part of the underwriting or
stabilizing process.
The Syndicate Members and their affiliates are diversified financial institutions with
relationships in countries around the world. These entities engage in a wide range of
commercial and investment banking, brokerage, funds management, trading, hedging,
investing and other activities for their own account and for the account of others. In the
ordinary course of their various business activities, the Syndicate Members and their respective
affiliates may purchase, sell or hold a broad array of investments and actively trade securities,
derivatives, loans, commodities, currencies, credit default swaps and other financial
instruments for their own account and for the accounts of their customers. Such investment and
trading activities may involve or relate to assets, securities and/or instruments of our Group
and/or persons and entities with relationships with our Group and may also include swaps and
other financial instruments entered into for hedging purposes in connection with our Group’s
loans and other debts.
In relation to the H Shares, the activities of the Syndicate Members and their affiliates
could include acting as agent for buyers and sellers of the H Shares, entering into transactions
with those buyers and sellers in a principal capacity, including as a lender to initial purchasers
of the H Shares (which financing may be secured by the H Shares) in the Global Offering,
proprietary trading in the H Shares, and entering into over the counter or listed derivative
transactions or listed or unlisted securities transactions (including issuing securities such as
derivative warrants listed on a stock exchange) which have as their underlying assets, assets
including the H Shares. Such transactions may be carried out as bilateral agreements or trades
with selected counterparties. Those activities may require hedging activity by those entities
involving, directly or indirectly, the buying and selling of the H Shares, which may have a
negative impact on the trading price of the H Shares. All such activities could occur in Hong
Kong and elsewhere in the world and may result in the Syndicate Members and their affiliates
holding long and/or short positions in the H Shares, in baskets of securities or indices including
the H Shares, in units of funds that may purchase the H Shares, or in derivatives related to any
of the foregoing.
UNDERWRITING
– 566 –


--- page 576 ---
In relation to issues by the Syndicate Members or their affiliates of any listed securities
having the H Shares as their underlying securities, whether on the Stock Exchange or on any
other stock exchange, the rules of the stock exchange may require the issuer of those securities
(or one of its affiliates or agents) to act as a market maker or liquidity provider in the security,
and this will also result in hedging activity in the H Shares in most cases.
All such activities may occur both during and after the end of the stabilizing period
described in “Structure of the Global Offering — Stabilization.” Such activities may affect the
market price or value of the H Shares, the liquidity or trading volume in the H Shares and the
volatility of the price of the H Shares, and the extent to which this occurs from day to day
cannot be estimated.
It should be noted that when engaging in any of these activities, the Syndicate Members
will be subject to certain restrictions, including the following:
(a) the Syndicate Members (other than the Stabilization Manager or its affiliates or any
person acting for it) must not, in connection with the distribution of the Offer
Shares, effect any transactions (including issuing or entering into any option or other
derivative transactions relating to the Offer Shares), whether in the open market or
otherwise, with a view to stabilizing or maintaining the market price of any of the
Offer Shares at levels other than those which might otherwise prevail in the open
market; and
(b) the Syndicate Members must comply with all applicable laws and regulations,
including the market misconduct provisions of the SFO, including the provisions
prohibiting insider dealing, false trading, price rigging and stock market
manipulation.
Certain of the Syndicate Members or their respective affiliates have provided from time
to time, and expect to provide in the future, investment banking and other services to our Group
and its affiliates for which such Syndicate Members or their respective affiliates have received
or will receive customary fees and commissions.
In addition, the Syndicate Members or their respective affiliates may provide financing to
investors to finance their subscriptions of Offer Shares in the Global Offering.
UNDERWRITING
– 567 –


--- page 577 ---
THE GLOBAL OFFERING
This Prospectus is published in connection with the Hong Kong Public Offering as part
of the Global Offering. CLSA Limited is the Sole Sponsor-Overall Coordinator of the Global
Offering.
The listing of the H Shares on the Stock Exchange is sponsored by the Sole Sponsor. The
Sole Sponsor have made an application on behalf of our Company to the Listing Committee of
the Stock Exchange for the listing of, and permission to deal in, the H Shares to be issued as
mentioned in this Prospectus.
77,600,000 Offer Shares will initially be made available (subject to the Offer Size
Adjustment Option and the Over-allotment Option) under the Global Offering comprising:
(a) the Hong Kong Public Offering of initially 7,760,000 H Shares (subject to
reallocation) in Hong Kong as described in “— The Hong Kong Public Offering”
below; and
(b) the International Offering of initially 69,840,000 H Shares (subject to reallocation,
the Offer Size Adjustment Option and the Over-allotment Option) (a) outside the
United States (including to professional and institutional investors within Hong
Kong) in offshore transactions in reliance on Regulation S and (b) in the United
States solely to QIBs in reliance on an exemption from registration under the U.S.
Securities Act provided by, and in accordance with the restrictions of, Rule 144A or
another exemption from, or in a transaction not subject to, the registration
requirements of the U.S. Securities Act, as described in “— The International
Offering” below.
Investors may either:
(i) apply for Hong Kong Offer Shares under the Hong Kong Public Offering; or
(ii) apply for or indicate an interest for International Offer Shares under the
International Offering,
but may not do both.
The Offer Shares will represent approximately 22.47% of the total Shares in issue
immediately following the completion of the Global Offering (assuming the Offer Size
Adjustment Option and the Over-allotment Option are not exercised). If the Offer Size
Adjustment Option and the Over-allotment Option are exercised in full, the Offer Shares
(including H Shares to be issued pursuant to the full exercise of the Offer Size Adjustment
Option and the Over-allotment Option) will represent approximately 27.71% of the total Shares
in issue immediately following the completion of the Global Offering and the issue of H Shares
pursuant to the Offer Size Adjustment Option and the Over-allotment Option.
References in this Prospectus to applications, application monies or the procedures for
applications relate solely to the Hong Kong Public Offering.
STRUCTURE OF THE GLOBAL OFFERING
– 568 –


--- page 578 ---
THE HONG KONG PUBLIC OFFERING
Number of Offer Shares Initially Offered
Our Company is initially offering 7,760,000 H Shares (subject to reallocation) for
subscription by the public in Hong Kong at the Offer Price, representing approximately 10%
of the Offer Shares initially available under the Global Offering. The Offer Shares initially
offered under the Hong Kong Public Offering, subject to any reallocation of Offer Shares
between the Hong Kong Public Offering and the International Offering, will represent
approximately 2.25% of the total Shares in issue immediately following the completion of the
Global Offering (assuming the Offer Size Adjustment Option and the Over-allotment Option
are not exercised).
The Hong Kong Public Offering is open to members of the public in Hong Kong as well
as to professional and institutional investors. Professional investors generally include brokers,
dealers, companies (including fund managers) whose ordinary business involves dealing in
shares and other securities and corporate entities that regularly invest in shares and other
securities.
Completion of the Hong Kong Public Offering is subject to the conditions set out in
“— Conditions of the Global Offering” below.
Allocation
Allocation of Offer Shares to investors under the Hong Kong Public Offering will be
based solely on the level of valid applications received under the Hong Kong Public Offering.
The basis of allocation may vary, depending on the number of Hong Kong Offer Shares validly
applied for by applicants. Such allocation could, where appropriate, consist of balloting, which
could mean that some applicants may receive a higher allocation than others who have applied
for the same number of Hong Kong Offer Shares, and those applicants who are not successful
in the ballot may not receive any Hong Kong Offer Shares.
For allocation purposes only, the total number of Hong Kong Offer Shares available under
the Hong Kong Public Offering (after taking into account any reallocation referred to below)
will be divided equally (to the nearest board lot) into two pools (with any odd lots being
allocated to pool A): pool A and pool B. The Hong Kong Offer Shares in pool A will be
allocated on an equitable basis to applicants who have applied for Hong Kong Offer Shares
with an aggregate price of HK$5 million (excluding brokerage, SFC transaction levy, AFRC
transaction levy and the Stock Exchange trading fee payable) or less. The Hong Kong Offer
Shares in pool B will be allocated on an equitable basis to applicants who have applied for
Hong Kong Offer Shares with an aggregate price of more than HK$5 million (excluding
brokerage, SFC transaction levy, AFRC transaction levy and the Stock Exchange trading fee
payable) and up to the total value in pool B.
STRUCTURE OF THE GLOBAL OFFERING
– 569 –


--- page 579 ---
Investors should be aware that applications in pool A and applications in pool B may
receive different allocation ratios. If any Hong Kong Offer Shares in one (but not both) of the
pools are unsubscribed, such unsubscribed Hong Kong Offer Shares will be transferred to the
other pool to satisfy demand in that other pool and be allocated accordingly. For the purpose
of the immediately preceding paragraph only, the “price” for Hong Kong Offer Shares means
the price payable on application therefor (without regard to the Offer Price as finally
determined). Applicants can only receive an allocation of Hong Kong Offer Shares from either
pool A or pool B and not from both pools. Multiple or suspected multiple applications under
the Hong Kong Public Offering and any application for more than 3,880,000 Hong Kong Offer
Shares is liable to be rejected.
Reallocation
The Offer Shares to be offered in the Hong Kong Public Offering and the International
Offering may, in certain circumstances, be reallocated as between these offerings at the
discretion of the Sole Sponsor-Overall Coordinator. Subject to the allocation cap described in
the subsequent paragraph, the Sole Sponsor-Overall Coordinator may in its discretion
reallocate Offer Shares from the International Offering to the Hong Kong Public Offering to
satisfy valid applications under the Hong Kong Public Offering. In addition, if the Hong Kong
Public Offering is not fully subscribed, the Sole Sponsor-Overall Coordinator will have the
discretion (but shall not be under any obligation) to reallocate to the International Offering all
or any unsubscribed Hong Kong Offer Shares in such amounts as they deem appropriate.
In each case, the additional Offer Shares reallocated to the Hong Kong Public Offering
will be allocated between Pool A and Pool B and the number of Offer Shares allocated to the
International Offering will be correspondingly reduced in such manner as the Sole Sponsor-
Overall Coordinator deems appropriate. In the event of reallocation of Offer Shares between
the International Offering and the Hong Kong Public Offering in the circumstances where (a)
the International Offer Shares are fully subscribed or oversubscribed and the Hong Kong Offer
Shares are fully subscribed or oversubscribed irrespective of the number of times, or (b) the
International Offer Shares are undersubscribed and the Hong Kong Offer Shares are fully
subscribed or oversubscribed irrespective of the number of times, then up to 3,880,000 Offer
Shares may be reallocated from the International Offering to the Hong Kong Public Offering,
so that the total number of Offer Shares available for subscription under the Hong Kong Public
Offering will increase up to 11,640,000 Offer Shares, representing approximately 15% of the
number of Offer Shares initially available under the Global Offering (before any exercise of the
Offer Size Adjustment Option and the Over-allotment Option) in accordance with Chapter 4.14
of the Guide for New Listing Applicants.
Given the initial allocation of the Offer Shares to the Hong Kong Public Offering and the
International Offering follows the provision of Paragraph 4.2(b) of Practice Note 18 of the
Listing Rules, no mandatory clawback or reallocation mechanism is required to increase the
number of Offer Shares under the Hong Kong Public Offering to a certain percentage of the
total number of Offer Shares offered under the Global Offering.
STRUCTURE OF THE GLOBAL OFFERING
– 570 –


--- page 580 ---
Applications
Each applicant under the Hong Kong Public Offering will be required to give an
undertaking and confirmation in the application submitted by him/her/it that he/she/it and any
person(s) for whose benefit he/she/it is making the application has not applied for or taken up,
or indicated an interest for, and will not apply for or take up, or indicate an interest for, any
International Offer Shares under the International Offering. Such applicant’s application under
the International Offering will be rejected if such undertaking and/or confirmation is/are
breached and/or untrue (as the case may be) or if he/she/it has been or will be placed or
allocated International Offer Shares under the International Offering.
Applicants under the Hong Kong Public Offering may (depending on application
channels) be required to pay, on application, the Offer Price of HK$20.39 per H Share plus
brokerage of 1.0%, SFC transaction levy of 0.0027%, AFRC transaction levy of 0.00015% and
the Stock Exchange trading fee of 0.00565%, amounting to a total of HK$4,119.13 for one
board lot of 200 H Shares.
THE INTERNATIONAL OFFERING
Number of Offer Shares Initially Offered
Subject to reallocation, the Offer Size Adjustment Option and the Over-allotment Option,
the International Offering will consist of an offering of initially 69,840,000 H Shares,
representing approximately 90% of the Offer Shares initially available under the Global
Offering. The Offer Shares initially offered under the International Offering, subject to any
reallocation of Offer Shares between the Hong Kong Public Offering and the International
Offering, will represent approximately 20.22% of the total Shares in issue immediately
following the completion of the Global Offering (assuming the Offer Size Adjustment Option
and the Over-allotment Option are not exercised).
Allocation
The International Offering will include selective marketing of Offer Shares to QIBs in the
United States in accordance with Rule 144A as well as professional and institutional investors
and other investors anticipated to have a sizeable demand for such Offer Shares in Hong Kong
and other jurisdictions outside the United States in reliance on Regulation S. Professional
investors generally include brokers, dealers, companies (including fund managers) whose
ordinary business involves dealing in shares and other securities and corporate entities that
regularly invest in shares and other securities. Allocation of Offer Shares pursuant to the
International Offering will be effected in accordance with the “book-building” process
described in “— Pricing and Allocation” below and based on a number of factors, including the
level and timing of demand, the total size of the relevant investor’s invested assets or equity
assets in the relevant sector and whether or not it is expected that the relevant investor is likely
to buy further H Shares and/or hold or sell its H Shares after the Listing. Such allocation is
intended to result in a distribution of the H Shares on a basis which would lead to the
establishment of a solid professional and institutional shareholder base to the benefit of our
Group and the Shareholders as a whole.
STRUCTURE OF THE GLOBAL OFFERING
– 571 –


--- page 581 ---
The Sole Sponsor-Overall Coordinator (for itself and on behalf of other Overall-
Coordinators and the Underwriters) require any investor who has been offered Offer Shares
under the International Offering and who has made an application under the Hong Kong Public
Offering to provide sufficient information to the Overall Coordinators so as to allow them to
identify the relevant applications under the Hong Kong Public Offering and to ensure that they
are excluded from any allocation of Offer Shares under the International Offering.
Reallocation
The total number of Offer Shares to be issued or sold pursuant to the International
Offering may change as a result of the exercise of the Offer Size Adjustment Option and the
Over-allotment Option in whole or in part described in the paragraphs headed “— Offer Size
Adjustment Option” and “— Over-allotment Option” in this section, and any reallocation of
unsubscribed Offer Shares originally included in the Hong Kong Public Offering and/or any
Offer Shares from the International Offering to the Hong Kong Public Offering at the discretion
of the Sole Sponsor-Overall Coordinator.
Offer Size Adjustment Option
In order to provide the Company with the flexibility to increase the number of Offer
Shares available for purchase under the International Offering to cover additional market
demand, our Company is expected to grant to the International Underwriters the Offer Size
Adjustment Option, exercisable by the Sole Sponsor-Overall Coordinator at its absolute
discretion (by itself and on behalf of the other Overall Coordinators and the International
Underwriters) on or before the second business day prior to the Listing Date and will lapse
immediately thereafter, to require our Company to issue and allot up to an aggregate of
11,640,000 additional H Shares, representing in aggregate approximately 15% of the total
number of the Offer Shares initially available under the Global Offering, at the Offer Price, to
cover any excess demand in the International Offering.
If the Offer Size Adjustment Option is exercised in full, the additional H Shares to be
issued pursuant thereto will represent approximately 3.26% of our issued share capital
immediately following the completion of the Global Offering (assuming the Over-allotment
Option is not exercised) and the full exercise of the Offer Size Adjustment Option.
The dilution effect of the Offer Size Adjustment Option (assuming the Over-allotment
Option is not exercised) is set out below:
Number of H Shares issued
under the Global Offering
before the exercise of the
Offer Size Adjustment
Option (“Original
Subscribers”)
Approximate percentage of
total issued share capital
held by the Original
Subscribers before the
exercise of the Offer Size
Adjustment Option
Number of H Shares issued
under the Global Offering
after the exercise of the
Offer Size Adjustment
Option
Approximate percentage of
total issued share capital
held by the Original
Subscribers after the
exercise of the Offer Size
Adjustment Option
77,600,000 22.47% 89,240,000 21.74%
STRUCTURE OF THE GLOBAL OFFERING
– 572 –


--- page 582 ---
The Offer Size Adjustment Option will not be used for price stabilization purposes and
will not be subject to the provisions of the Securities and Futures (Price Stabilizing) Rules
(Chapter 571W of the Laws of Hong Kong). The Offer Size Adjustment Option will be in
addition to the Over-allotment Option.
If the Offer Size Adjustment Option is exercised in full, the additional net proceeds
received from the placing of the additional H Shares allotted and issued will be allocated in
accordance with the allocations as disclosed in the section headed “Future Plans and Use of
Proceeds” in this prospectus, on a pro rata basis.
The Company will disclose in its allotment results announcement if and to what extent the
Offer Size Adjustment Option has been exercised, or will confirm that if the Offer Size
Adjustment Option has not been exercised by the second business day prior to the Listing Date,
it will lapse and cannot be exercised at any future date.
OVER-ALLOTMENT OPTION
In connection with the Global Offering, our Company is expected to grant the
Over-allotment Option to the International Underwriters, exercisable by the Sole Sponsor-
Overall Coordinator (for itself and on behalf of other Overall-Coordinators and the
International Underwriters).
Pursuant to the Over-allotment Option, the International Underwriters will have the right,
exercisable by the Sole Sponsor-Overall Coordinator (for itself and on behalf of other
Overall-Coordinators and the International Underwriters) at any time from the Listing Date
until 30 days after the last day for lodging applications under the Hong Kong Public Offering,
being Thursday, October 16, 2025, to require our Company to issue up to an aggregate of
11,640,000 additional H Shares (representing not more than 15% of the Offer Shares initially
available under the Global Offering assuming the Offer Size Adjustment Option is not
exercised at all) or up to an aggregate of 13,386,000 additional H Shares (representing not
more than 15% of the Offer Shares initially available under the Global Offering assuming the
Offer Size Adjustment Option is exercised in full), in each case, taking into account the Share
Subdivision, at the Offer Price to, among other things, cover over-allocations in the
International Offering, if any.
If the Offer Size Adjustment Option is not exercised and the Over-allotment Option is
exercised in full, the additional International Offer Shares to be issued pursuant thereto will
represent approximately 3.26% of our Company’s enlarged issued share capital immediately
following the completion of the Global Offering and the exercise of the Over-allotment Option.
If the Offer Size Adjustment Option and the Over-allotment Option are both exercised in full,
the additional International Offer Shares to be issued pursuant thereto will represent
approximately 6.76% of our Company’s enlarged issued share capital immediately following
the completion of the Global Offering and the exercise of the Offer Size Adjustment Option and
the Over-allotment Option. In the event that the Over-allotment Option is exercised, an
announcement will be made.
STRUCTURE OF THE GLOBAL OFFERING
– 573 –


--- page 583 ---
STABILIZATION
Stabilization is a practice used by underwriters in some markets to facilitate the
distribution of securities. To stabilize, the underwriters may bid for, or purchase, the securities
in the secondary market, during a specified period of time, to retard and, if possible, prevent
a decline in the initial public market price of the securities below the offer price. Such
transactions may be effected in all jurisdictions where it is permissible to do so, in each case
in compliance with all applicable laws and regulatory requirements, including those of Hong
Kong. In Hong Kong, the price at which stabilization is effected is not permitted to exceed the
offer price.
In connection with the Global Offering, the Stabilization Manager (or its affiliates or any
person acting for it), on behalf of the Underwriters, may over-allocate or effect transactions
with a view to stabilizing or supporting the market price of the H Shares at a level higher than
that which might otherwise prevail for a limited period after the Listing Date. However, there
is no obligation on the Stabilization Manager (or its affiliates or any person acting for it) to
conduct any such stabilizing action. Such stabilizing action, if taken, (a) will be conducted at
the absolute discretion of the Stabilization Manager (or its affiliates or any person acting for
it) and in what the Stabilization Manager reasonably regards as the best interest of our
Company, (b) may be discontinued at any time and (c) is required to be brought to an end
within 30 days after the last day for lodging applications under the Hong Kong Public Offering.
Stabilization action permitted in Hong Kong pursuant to the Securities and Futures (Price
Stabilizing) Rules of the SFO includes (a) over-allocating for the purpose of preventing or
minimizing any reduction in the market price of the H Shares, (b) selling or agreeing to sell
the H Shares so as to establish a short position in them for the purpose of preventing or
minimizing any reduction in the market price of the H Shares, (c) purchasing or subscribing
for or agreeing to purchase or subscribe for the H Shares pursuant to the Over-allotment Option
in order to close out any position established under paragraph (a) or (b) above, (d) purchasing
or agreeing to purchase any of the H Shares for the sole purpose of preventing or minimizing
any reduction in the market price of the H Shares, (e) selling or agreeing to sell any H Shares
in order to liquidate any position established as a result of those purchases and (f) offering or
attempting to do anything as described in paragraph (b), (c), (d) or (e) above.
Specifically, prospective applicants for and investors in the Offer Shares should note that:
(a) the Stabilization Manager (or its affiliates or any person acting for it) may, in
connection with the stabilizing action, maintain a long position in the H Shares;
(b) there is no certainty as to the extent to which and the time or period for which the
Stabilization Manager (or its affiliates or any person acting for it) will maintain such
a long position;
STRUCTURE OF THE GLOBAL OFFERING
– 574 –


--- page 584 ---
(c) liquidation of any such long position by the Stabilization Manager (or its affiliates
or any person acting for it) and selling in the open market may have an adverse
impact on the market price of the H Shares;
(d) no stabilizing action can be taken to support the price of the H Shares for longer than
the stabilization period, which will begin on the Listing Date and is expected to
expire on Thursday, October 16, 2025, being the 30th day after the last day for
lodging applications under the Hong Kong Public Offering. After this date, when no
further stabilizing action may be taken, demand for the H Shares, and therefore the
price of the H Shares, could fall;
(e) the price of the H Shares cannot be assured to stay at or above the Offer Price by
the taking of any stabilizing action; and
(f) stabilizing bids or transactions effected in the course of the stabilizing action may
be made at any price at or below the Offer Price and can, therefore, be done at a
price below the price paid by applicants for, or investors in, the Offer Shares.
In order to effect stabilizing actions, the Stabilization Manager will arrange cover of up
to an aggregate of 11,640,000 H Shares (representing not more than 15% of the Offer Shares
initially available under the Global Offering assuming the Offer Size Adjustment Option is not
exercised at all) or up to an aggregate of 13,386,000 additional H Shares (representing not
more than 15% of the Offer Shares initially available under the Global Offering assuming the
Offer Size Adjustment Option is exercised in full), in each case, taking into account the Share
Subdivision, through delayed delivery arrangements with investors who have been allocated
Offer Shares in the International Offering. The delayed delivery arrangements (if specifically
agreed by an investor) relate only to the delay in the delivery of the Offer Shares to such
investor and the Offer Price for the Offer Shares allocated to such investor will be fully paid
on or before the Listing Date.
Our Company will ensure or procure that an announcement in compliance with the
Securities and Futures (Price Stabilizing) Rules of the SFO will be made within seven days of
the expiration of the stabilization period.
Over-allocation
Following any over-allocation of H Shares in connection with the Global Offering, the
Stabilization Manager (or its affiliates or any person acting for it) may cover such
over-allocations by exercising the Over-allotment Option in full or in part, by using H Shares
purchased by the Stabilization Manager (or its affiliates or any person acting for it) in the
secondary market at prices that do not exceed the Offer Price, or by a combination of these
methods.
STRUCTURE OF THE GLOBAL OFFERING
– 575 –


--- page 585 ---
PRICING AND ALLOCATION
The Offer Price will be HK$20.39 per H Share, unless otherwise announced by our
Company no later than the morning of the last day for lodging applications under the Hong
Kong Public Offering, as further explained below.
The International Underwriters will be soliciting from prospective investors indications
of interest in acquiring Offer Shares in the International Offering. Prospective professional and
institutional investors will be required to specify the number of Offer Shares under the
International Offering they would be prepared to acquire either at different prices or at a
particular price. This process, known as “book-building,” is expected to continue up to, and to
cease on or about, the last day for lodging applications under the Hong Kong Public Offering.
The Sole Sponsor-Overall Coordinator (for itself and on behalf of other Overall-
Coordinators and the Underwriters) may, where it deems appropriate, based on the level of
interest expressed by prospective investors during the book-building process, and with the
consent of our Company, reduce the number of Offer Shares and/or the Offer Price below that
stated in this Prospectus at any time on or prior to the morning of the last day for lodging
applications under the Hong Kong Public Offering. In such case, our Company will, as soon
as practicable following the decision to make such reduction, and in any event not later than
the morning of the last day for lodging applications under the Hong Kong Public Offering,
cause to be published on the website of the Stock Exchange at www.hkexnews.hk and our
website at www.genfleet.com notices of the reduction in the number of Offer Shares and/or the
Offer Price, the cancelation of the Global Offering and the relaunch of the offering at the
revised number of Offer Shares and/or Offer Price. Our Company will also, as soon as
practicable following the decision to make such reduction, issue a supplemental or new
prospectus updating investors of the reduction in the number of Offer Shares and/or the Offer
Price, and giving investors at least three business days to consider the new information. The
supplemental or new prospectus shall include at least the following: updated (a) Offer Price
and market capitalization; (b) listing timetable and underwriting obligations; (c) price/earnings
multiple (if applicable), unaudited pro forma and adjusted net tangible assets; and (d) use of
proceeds and working capital adequacy confirmation based on revised estimated proceeds. In
the event of a reduction in the number of Offer Shares, the Sole Sponsor-Overall Coordinator
may also at its discretion reallocate the number of Offer Shares to be offered under the Hong
Kong Public Offering and the International Offering. In the absence of any such supplemental
or new prospectus so published, the number of Offer Shares will not be reduced and the Offer
Price will be HK$20.39 per H Share.
If there is any change to the offer size due to change in the number of Offer Shares
initially offered under the Global Offering (other than pursuant to the exercise of the Offer Size
Adjustment Option, the Over-allotment Option and/or the reallocation mechanism as disclosed
in this Prospectus), or if there is any change to the Offer Price, or if our Company becomes
aware that there has been a significant change affecting any matter contained in this Prospectus
or a significant new matter has arisen, the inclusion of information in respect of which would
have been required to be in this Prospectus if it had arisen before this Prospectus was issued,
STRUCTURE OF THE GLOBAL OFFERING
– 576 –


--- page 586 ---
after the issue of this Prospectus and before the commencement of dealings in our H Shares as
prescribed under Rule 11.13 of the Listing Rules, we are required to cancel the Global Offering
and relaunch the offering and issue a supplemental or new prospectus.
The level of applications in the Hong Kong Public Offering, the level of indications of
interest in the International Offering and the basis of allocation of the Hong Kong Offer Shares
are expected to be announced on Thursday, September 18, 2025 on the website of the Stock
Exchange at www.hkexnews.hk and our website at www.genfleet.com .
UNDERWRITING
The Hong Kong Public Offering is fully underwritten by the Hong Kong Underwriters
under the terms and conditions of the Hong Kong Underwriting Agreement. Our Company
expects to enter into the International Underwriting Agreement relating to the International
Offering on or about September 17, 2025. These underwriting arrangements, including the
Underwriting Agreements, are summarized in “Underwriting.”
CONDITIONS OF THE GLOBAL OFFERING
Acceptance of all applications for Offer Shares will be conditional on:
(a) the Listing Committee granting approval for the listing of, and permission to deal in,
the H Shares to be issued pursuant to the Global Offering (including any additional
H Shares that may be issued pursuant to the exercise of the Offer Size Adjustment
Option and the Over-allotment Option) on the Main Board of the Stock Exchange,
and such approval and permission not subsequently having been withdrawn or
revoked prior to the commencement of dealings in the H Shares on the Stock
Exchange;
(b) the execution and delivery of the International Underwriting Agreement; and
(c) the obligations of the Hong Kong Underwriters under the Hong Kong Underwriting
Agreement and the obligations of the International Underwriters under the
International Underwriting Agreement becoming and remaining unconditional and
not having been terminated in accordance with the terms of the respective
agreements,
in each case on or before the dates and times specified in the respective Underwriting
Agreements (unless and to the extent such conditions are validly waived on or before such
dates and times) and, in any event, not later than the date which is 30 days after the date of
this Prospectus.
The consummation of each of the Hong Kong Public Offering and the International
Offering is conditional upon, among other things, the other offering becoming unconditional
and not having been terminated in accordance with its terms.
STRUCTURE OF THE GLOBAL OFFERING
– 577 –


--- page 587 ---
If the above conditions are not fulfilled or waived prior to the dates and times specified,
the Global Offering will lapse and the Stock Exchange will be notified immediately. Notice of
the lapse of the Hong Kong Public Offering will be published on the website of the Stock
Exchange at www.hkexnews.hk and our website at www.genfleet.com on the next day
following such lapse. In such a situation, all application monies will be returned, without
interest, on the terms set out in “How to Apply for Hong Kong Offer Shares — D.
Dispatch/Collection of H Share Certificates and Refund of Application Monies.” In the
meantime, all application monies will be held in separate bank account(s) with the receiving
bank or other bank(s) in Hong Kong licensed under the Banking Ordinance (Chapter 155 of the
Laws of Hong Kong).
The H Share certificates for the Offer Shares will only become valid evidence of title at
8:00 a.m. on the Listing Date, which is expected to be Friday, September 19, 2025 (Hong Kong
time), provided that the Global Offering has become unconditional in all respects and the right
of termination described in “Underwriting — Underwriting Arrangements and Expenses —
Hong Kong Public Offering — Grounds for Termination” has not been exercised. Investors
who trade H Shares prior to the receipt of H Share certificates or prior to the H Share
certificates becoming valid evidence of title do so entirely at their own risk.
DEALINGS IN THE H SHARES
Assuming that the Hong Kong Public Offering becomes unconditional at or before 8:00
a.m. in Hong Kong on Friday, September 19, 2025, it is expected that dealings in the H Shares
on the Stock Exchange will commence at 9:00 a.m. on Friday, September 19, 2025.
The H Shares will be traded in board lots of 200 H Shares each and the stock code of the
H Shares will be 2595.
STRUCTURE OF THE GLOBAL OFFERING
– 578 –


--- page 588 ---
IMPORTANT NOTICE TO INVESTORS
OF HONG KONG OFFER SHARES
FULLY ELECTRONIC APPLICATION PROCESS
We have adopted a fully electronic application process for the Hong Kong
Public Offering and below are the procedures for application.
This Prospectus is available at the website of the Stock Exchange at
www.hkexnews.hk under “HKEXnews > New Listings > New Listing Information” and
our website at www.genfleet.com .
The contents of this Prospectus are identical to the Prospectus as registered with the
Registrar of Companies in Hong Kong pursuant to Section 342C of the Companies
(Winding Up and Miscellaneous Provisions) Ordinance.
A. APPLICATION FOR HONG KONG OFFER SHARES
1. Who Can Apply
Y ou can apply for Hong Kong Offer Shares if you or the person(s) for whose benefit you
are applying:
 are 18 years of age or older;
 have a Hong Kong address (for the White Form eIPO service only); and
 are outside the United States, and are not a United States Person (as defined in
Regulation S under the U.S. Securities Act).
Unless permitted by the Listing Rules, you cannot apply for any Hong Kong Offer Shares
if you or the person(s) for whose benefit you are applying:
 are an existing Shareholder or a Director;
 are a close associate of any of the above;
 are a core connected person (as defined in the Listing Rules) of the Company or will
become a core connected person of the Company immediately upon completion of
the Global Offering; or
 have been allocated or have applied for any International Offer Shares or otherwise
participated in the International Offering.
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 579 –


--- page 589 ---
2. Application Channels
The Hong Kong Public Offering period will begin at 9:00 a.m. on Thursday,
September 11, 2025 and end at 12:00 noon on Tuesday, September 16, 2025 (Hong Kong
time).
To apply for Hong Kong Offer Shares, you may use one of the following application
channels:
Application Channel Platform Target Investors Application Time
White Form eIPO
service /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
www.eipo.com.hk Applicants who would like
to receive a physical H
Share certificate. Hong
Kong Offer Shares
successfully applied for
will be allotted and
issued in your own
name.
From 9:00 a.m. on
Thursday, September 11,
2025 to 11:30 a.m. on
Tuesday, September 16,
2025 (Hong Kong time).
The latest time for
completing full payment
of application monies
will be 12:00 noon on
Tuesday, September 16,
2025 (Hong Kong time).
HKSCC EIPO
channel /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Y our broker or custodian
who is a HKSCC
Participant will submit
electronic application
instruction(s) on your
behalf through
HKSCC’s FINI system
in accordance with
your instructions.
Applicants who would not
like to receive a
physical H Share
certificate. Hong Kong
Offer Shares
successfully applied for
will be allotted and
issued in the name of
HKSCC Nominees,
deposited directly into
CCASS and credited to
your designated HKSCC
Participant’s stock
account.
Contact your broker or
custodian for the earliest
and latest time for
giving such instructions,
as this may vary by
broker or custodian.
The White Form eIPO service and the HKSCC EIPO channel are facilities subject to
capacity limitations and potential service interruptions, and you are advised not to wait until
the last day for applications to apply for Hong Kong Offer Shares.
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 580 –


--- page 590 ---
For those applying through the White Form eIPO service, once you complete payment
in respect of any application instruction given by you or for your benefit through the White
Form eIPO service to make an application for Hong Kong Offer Shares, an actual application
shall be deemed to have been made. If you are a person for whose benefit the application
instructions are given, you shall be deemed to have declared that only one set of application
instructions has been given for your benefit. If you are an agent for another person, you shall
be deemed to have declared that you have only given one set of application instructions for the
benefit of the person for whom you are an agent and that you are duly authorized to give those
instructions as an agent.
For the avoidance of doubt, giving an application instruction under the White Form eIPO
service more than once and obtaining different application reference numbers without effecting
full payment in respect of a particular reference number will not constitute an actual
application.
If you apply through the White Form eIPO service, you are deemed to have authorized
the White Form eIPO Service Provider to apply on the terms and conditions in this
Prospectus, as supplemented and amended by the terms and conditions of the White Form
eIPO service.
By instructing your broker or custodian to apply for Hong Kong Offer Shares on your
behalf through the HKSCC EIPO channel, you (and, if you are joint applicants, each of you
jointly and severally) are deemed to have instructed and authorized HKSCC to cause HKSCC
Nominees (acting as nominee for the relevant HKSCC Participants) to apply for Hong Kong
Offer Shares on your behalf and to do on your behalf all the things stated in this Prospectus
and any supplement to it.
For those applying through the HKSCC EIPO channel, an actual application will be
deemed to have been made for any application instruction given by you or for your benefit to
HKSCC (in which case an application will be made by HKSCC Nominees on your behalf)
provided such application instruction has not been withdrawn or otherwise invalidated before
the closing time of the Hong Kong Public Offering.
HKSCC Nominees will only be acting as a nominee for you and neither HKSCC nor
HKSCC Nominees shall be liable to you or any other person in respect of any actions taken by
HKSCC or HKSCC Nominees on your behalf to apply for Hong Kong Offer Shares or for any
breach of the terms and conditions of this Prospectus.
3. Information Required to Apply
Y ou must provide the following information with your application:
For Individual/Joint Applicants For Corporate Applicants
 Full name(s) (2) as shown on your
identity document
 Full name(s) (2) as shown on your
identity document
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 581 –


--- page 591 ---
For Individual/Joint Applicants For Corporate Applicants
 Identity document’s issuing country
or jurisdiction
 Identity document’s issuing country
or jurisdiction
 Identity document type, with order
of priority:
i. Hong Kong identity card
(“HKID ”); or
ii. National identification document;
or
iii. Passport
 Identity document number
 Identity document type, with order of
priority:
i. Legal Entity Identifier (“ LEI”)
registration document; or
ii. Certificate of incorporation; or
iii. Business registration certificate;
or
iv. Other equivalent document
 Identity document number
Notes:
(1) If you are applying through the White Form eIPO service, you are required to provide a valid e-mail
address, a contact telephone number and a Hong Kong address. Y ou are also required to declare that the
identity information provided by you follows the requirements as described in Note 2 below. In
particular, where you cannot provide a HKID number, you must confirm that you do not hold a HKID.
(2) The applicant’s full name as shown on their identity document must be used and the surname, given
name, middle and other names (if any) must be input in the same order as shown on the identity
document. If an applicant’s identity document contains both English and Chinese names, both English
and Chinese names must be used. Otherwise, either English or Chinese name will be accepted. The order
of priority of the applicant’s identity document type must be strictly followed and where an individual
applicant has a valid HKID card (including both Hong Kong Residents and Hong Kong Permanent
Residents), the HKID number must be used when making an application for Hong Kong Offer Shares.
Similarly, for corporate applicants, a LEI number must be used if an entity has a LEI certificate.
(3) If the applicant is a trustee, the client identification data (“ CID”) of the trustee, as set out above, will
be required. If the applicant is an investment fund (i.e. a collective investment scheme, or CIS), the CID
of the asset management company or the individual fund, as appropriate, which has opened a trading
account with the broker will be required, as above.
(4) The maximum number of joint applicants on FINI is capped at 4 in accordance with market practice.
(5) If you are applying as a nominee, you must provide: (i) the full name (as shown on the identity
document), the identity document’s issuing country or jurisdiction, the identity document type; and (ii)
the identity document number, for each of the beneficial owners or, in the case(s) of joint beneficial
owners, for each of the joint beneficial owners. If you do not include this information, the application
will be treated as being made for your benefit.
(6) If an application is made by an unlisted company and (i) the principal business of that company is
dealing in securities; and (ii) you exercise statutory control over that company, then the application will
be treated as being for your benefit and you should provide the required information in your application
as stated above.
“Unlisted company ” means a company with no equity securities listed on the Stock Exchange or any
other stock exchange.
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“Statutory control ” means you:
 control the composition of the board of directors of the company;
 control more than half of the voting power of the company; or
 hold more than half of the issued share capital of the company (not counting any part of it which
carries no right to participate beyond a specified amount in a distribution of either profits or
capital).
For those applying through the HKSCC EIPO channel and making an application under
a power of attorney, the Overall Coordinators may accept it at its discretion and on any
conditions they think fit, including evidence of the attorney’s authority.
Failing to provide any required information may result in your application being rejected.
4. Permitted Number of Hong Kong Offer Shares for Application
Board lot size /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118: 200 H Shares
Permitted number of Hong
Kong Offer Shares for
application and amount
payable on application/
successful allotment /H1118/H1118/H1118/H1118/H1118/H1118
: Hong Kong Offer Shares are available for
application in specified board lot sizes only.
Please refer to the amount payable associated
with each specified board lot size in the table
below.
The Offer Price is HK$20.39 per H Share, plus
brokerage of 1.0%, SFC transaction levy of
0.0027%, AFRC transaction levy of 0.00015%
and the Stock Exchange trading fee of
0.00565%.
If you are applying through the White Form
eIPO service, you may refer to the table below
for the amount payable for the number of H
Shares you have selected. Y ou must pay the
respective maximum amount payable on
application in full upon application for Hong
Kong Offer Shares.
If you are applying through the HKSCC EIPO
channel, your broker or custodian may require
you to pre-fund your application in such amount
as determined by the broker or custodian, based
on the applicable laws and regulations in Hong
Kong. Y ou are responsible for complying with
any such pre-funding requirement imposed by
your broker or custodian with respect to the
Hong Kong Offer Shares you applied for.
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--- page 593 ---
By instructing your broker or custodian to apply
for Hong Kong Offer Shares on your behalf
through the HKSCC EIPO channel, you (and,
if you are joint applicants, each of you jointly
and severally) are deemed to have instructed
and authorized HKSCC to cause HKSCC
Nominees (acting as nominee for the relevant
HKSCC Participants) to arrange payment of the
Offer Price, brokerage, SFC transaction levy,
AFRC transaction levy and the Stock Exchange
trading fee by debiting the relevant nominee
bank account at the designated bank for your
broker or custodian.
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2) on
application
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2) on
application
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2) on
application
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2) on
application
HK$ HK$ HK$ HK$
200 4,119.13 5,000 102,978.16 80,000 1,647,650.65 700,000 14,416,943.20
400 8,238.25 6,000 123,573.79 90,000 1,853,606.98 800,000 16,476,506.52
600 12,357.38 7,000 144,169.42 100,000 2,059,563.31 900,000 18,536,069.84
800 16,476.50 8,000 164,765.06 150,000 3,089,344.98 1,000,000 20,595,633.16
1,000 20,595.63 9,000 185,360.70 200,000 4,119,126.64 1,500,000 30,893,449.73
1,200 24,714.76 10,000 205,956.34 250,000 5,148,908.29 2,000,000 41,191,266.30
1,400 28,833.88 20,000 411,912.66 300,000 6,178,689.95 2,500,000 51,489,082.88
1,600 32,953.01 30,000 617,869.00 350,000 7,208,471.60 3,000,000 61,786,899.46
1,800 37,072.14 40,000 823,825.32 400,000 8,238,253.25 3,880,000
(1) 79,911,056.63
2,000 41,191.26 50,000 1,029,781.66 450,000 9,268,034.92
3,000 61,786.90 60,000 1,235,737.99 500,000 10,297,816.58
4,000 82,382.53 70,000 1,441,694.32 600,000 12,357,379.89
Notes:
(1) The maximum number of Hong Kong Offer Shares you may apply for, which is 50% of the Offer Shares
initially available for subscription under the Hong Kong Public Offering.
(2) The amount payable is inclusive of brokerage, SFC transaction levy, AFRC transaction levy and the Stock
Exchange trading fee. If your application is successful, the brokerage will be paid to the Exchange Participants
(as defined in the Listing Rules) and the SFC transaction levy, the AFRC transaction levy and the Stock
Exchange trading fee will be paid to the Stock Exchange (in the case of the SFC transaction levy and the AFRC
transaction levy, collected by the Stock Exchange on behalf of the SFC and the AFRC, respectively).
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--- page 594 ---
5. Multiple Applications Prohibited
Y ou or your joint applicant(s) shall not make more than one application for your own
benefit, except where you are a nominee and provide the information of the underlying investor
in your application as required under “— A. Application for Hong Kong Offer Shares — 3.
Information Required to Apply” above. If you are suspected of submitting or causing to be
submitted more than one application, all of your applications will be rejected.
Multiple applications made either through (i) the White Form eIPO service, (ii) the
HKSCC EIPO channel or (iii) both channels concurrently are prohibited and will be rejected.
If you have made an application through the White Form eIPO service or the HKSCC EIPO
channel, you or the person(s) for whose benefit you have made the application shall not apply
for any International Offer Shares.
6. Terms and Conditions of an Application
By applying for Hong Kong Offer Shares through the White Form eIPO service or the
HKSCC EIPO channel, you (or as the case may be, HKSCC Nominees will do the following
things on your behalf):
(i) undertake to execute all relevant documents and instruct and authorize us and/or the
Overall Coordinators (or their agents or nominees), as our agents, to execute any
documents for you and to do on your behalf all things necessary to register any Hong
Kong Offer Shares allocated to you in your name or in the name of HKSCC
Nominees as required by the Articles of Association, and (if you are applying
through the HKSCC EIPO channel) to deposit the allotted Hong Kong Offer Shares
directly into CCASS for the credit of your designated HKSCC Participant’s stock
account on your behalf;
(ii) confirm that you have read and understood the terms and conditions and application
procedures set out in this Prospectus and the designated website of the White Form
eIPO service (or as the case may be, the agreement you entered into with your
broker or custodian), and agree to be bound by them;
(iii) (if you are applying through the HKSCC EIPO channel) agree to the arrangements,
undertakings and warranties under the participant agreement between your broker or
custodian and HKSCC and observe the General Rules of HKSCC and the HKSCC
Operational Procedures for giving application instructions to apply for Hong Kong
Offer Shares;
(iv) confirm that you are aware of the restrictions on the Hong Kong Public Offering set
out in this Prospectus and they do not apply to you or the person(s) for whose benefit
you have made the application;
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--- page 595 ---
(v) confirm that you have read this Prospectus and any supplement to it, and have relied
only on the information and representations contained therein in making your
application (or as the case may be, causing your application to be made), and will
not rely on any other information or representations;
(vi) agree that we, the Sole Sponsor, the Sole Sponsor-Overall Coordinator, the Overall
Coordinators, the Joint Global Coordinators, the Joint Bookrunners, the Joint Lead
managers, the Capital Market Intermediaries, the Underwriters, our and their
respective directors, supervisors, officers, employees, partners, agents, advisors and
other parties involved in the Global Offering (the “ Relevant Persons ”), the H Share
Registrar, the White Form eIPO Service Provider and HKSCC will not be liable for
any information and representations not in this Prospectus and any supplement to it;
(vii) undertake and confirm that you or the person(s) for whose benefit you have made
the application have not applied for or taken up, or indicated an interest in, and will
not apply for or take up, or indicate an interest in, any International Offer Shares nor
participated in the International Offering;
(viii) agree to disclose the details of your application and your personal data and any other
personal data which may be required about you and the person(s) for whose benefit
you have made the application to us, the Relevant Persons, the H Share Registrar,
HKSCC, HKSCC Nominees, the Stock Exchange, the SFC and any other statutory
regulatory or governmental bodies or otherwise as required by laws, rules or
regulations, for the purposes specified under “— G. Personal Data” below;
(ix) agree (without prejudice to any other rights which you may have once your
application (or as the case may be, HKSCC Nominees’ application) has been
accepted) that you will not rescind it because of an innocent misrepresentation;
(x) agree that subject to Section 44A(6) of the Companies (Winding Up and
Miscellaneous Provisions) Ordinance, any application made by you or HKSCC
Nominees on your behalf cannot be revoked once it is accepted, which will be
evidenced by the notification of the result of the ballot by the H Share Registrar by
way of publication of the results at the time and in the manner as specified in
“— B. Publication of Results” below;
(xi) confirm that you are aware of the situations specified in “— C. Circumstances in
Which Y ou Will Not Be Allocated Hong Kong Offer Shares” below;
(xii) agree that your application or HKSCC Nominees’ application, any acceptance of it
and the resulting contract will be governed by and construed in accordance with the
laws of Hong Kong;
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--- page 596 ---
(xiii) agree and warrant that you have complied with the Companies Ordinance, the
Companies (Winding Up and Miscellaneous Provisions) Ordinance, the Cayman
Companies Act, the Memorandum and Articles of Association, and laws of any place
outside Hong Kong that apply to your application, and that neither we nor the
Relevant Persons will breach any law inside and/or outside Hong Kong as a result
of the acceptance of your offer to purchase, or any action arising from your rights
and obligations under the terms and conditions contained in this Prospectus;
(xiv) represent, warrant and undertake that (a) you understand that the Hong Kong Offer
Shares have not been and will not be registered under the U.S. Securities Act; and
(b) you and the person(s) for whose benefit you have made the application are
outside the United States (as defined in Regulation S) or are a person described in
paragraph (h)(3) of Rule 902 of Regulation S;
(xv) confirm that (a) your application or HKSCC Nominees’ application on your behalf
is not financed directly or indirectly by the Company, any of the directors, chief
executives, substantial shareholder(s) or existing shareholder(s) of the Company or
any of its subsidiaries or any of their respective close associates; and (b) you are not
accustomed or will not be accustomed to taking instructions from the Company, any
of the directors, chief executives, substantial shareholder(s) or existing
shareholder(s) of the Company or any of its subsidiaries or any of their respective
close associates in relation to the acquisition, disposal, voting or other disposition
of the H Shares registered in your name or otherwise held by you;
(xvi) warrant that the information you have provided is true and accurate;
(xvii) confirm that you understand that we and the Overall Coordinators will rely on your
declarations and representations in deciding whether or not to allocate any Hong
Kong Offer Shares to you, and that you may be prosecuted for making a false
declaration;
(xviii) agree to accept Hong Kong Offer Shares applied for or any lesser number allocated
to you under the application;
(xix) authorize us to place your name(s) or the name of HKSCC Nominees on our register
of members as the holder(s) of any Hong Kong Offer Shares allocated to you and
such other registers as may be required under the Memorandum and Articles of
Association, and we and/or our agents to send any H Share certificate(s) and/or any
White Form e-Refund payment instructions and/or any refund check(s) to you or
the first-named applicant for joint application to the address specified in your
application instructions by ordinary post at your own risk, unless you are eligible to
collect the H Share certificate(s) and/or refund check(s) in person;
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--- page 597 ---
(xx) declare and represent that this is the only application made and the only application
intended by you to be made to benefit you or the person for whose benefit you are
applying;
(xxi) (if the application is made for your own benefit) warrant that no other application
has been or will be made for your benefit by giving application instructions to
HKSCC directly or indirectly or through the White Form eIPO service or by you
or by anyone as your agent or by any other person; and
(xxii) (if you are making the application as an agent for the benefit of another person)
warrant that (a) no other application has been or will be made by you as agent for
or for the benefit of that person or by that person or by any other person as agent
for that person by giving application instructions to HKSCC and (b) you have due
authority to give application instructions on behalf of that other person as its agent.
B. PUBLICATION OF RESULTS
Results of Allocation
Y ou can check whether you are successfully allocated any Hong Kong Offer Shares
through:
Platform Date/Time
Applying through White Form eIPO service or HKSCC EIPO channel:
Website /H1118/H1118/H1118The designated results of allocation
website at www.iporesults.com.hk
(alternatively:
www.eipo.com.hk/eIPOAllotment )
with a “search by ID” function.
24 hours, from 11:00 p.m. on
Thursday, September 18,
2025 to 12:00 midnight on
Wednesday, September 24,
2025 (Hong Kong time).
The full list of (i) wholly or partially
successful applicants using the White
Form eIPO service and HKSCC
EIPO channel, and (ii) the number of
Hong Kong Offer Shares conditionally
allotted to them, among other things,
will be displayed on the “Allotment
Results” page of the White Form
eIPO service at
www.iporesults.com.hk (alternatively:
www.eipo.com.hk/eIPOAllotment ).
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 598 ---
Platform Date/Time
The Stock Exchange’s website at
www.hkexnews.hk and our website at
www.genfleet.com , which will provide
links to the above-mentioned websites
of the H Share Registrar.
By 11:00 p.m. on Thursday,
September 18, 2025 (Hong
Kong time).
Telephone /H1118+852 2862 8555 — the allocation results
telephone enquiry line provided by the
H Share Registrar
Between 9:00 a.m. and 6:00
p.m. on Friday, September
19, 2025, Monday,
September 22, 2025,
Tuesday, September 23,
2025 and Wednesday,
September 24, 2025 (Hong
Kong time).
For those applying through the HKSCC EIPO channel, you may also check with your
broker or custodian from 6:00 p.m. on Wednesday, September 17, 2025 (Hong Kong time).
HKSCC Participants can log into FINI and review the allotment result from 6:00 p.m. on
Wednesday, September 17, 2025 (Hong Kong time) on a 24-hour basis, and should report any
discrepancies on allotments to HKSCC as soon as practicable.
Allocation Announcement
We expect to announce the level of indications of interest in the International Offering,
the level of applications in the Hong Kong Public Offering and the basis of allocations of the
Hong Kong Offer Shares on the Stock Exchange’s website at www.hkexnews.hk and our
website at www.genfleet.com by no later than 11:00 p.m. on Thursday, September 18, 2025
(Hong Kong time).
C. CIRCUMSTANCES IN WHICH YOU WILL NOT BE ALLOCATED HONG KONG
OFFER SHARES
Y ou should note the following situations in which Hong Kong Offer Shares will not be
allocated to you or the person(s) for whose benefit you are applying:
1. If your application is revoked:
Y our application or the application made by HKSCC Nominees on your behalf may be
revoked pursuant to Section 44A(6) of the Companies (Winding Up and Miscellaneous
Provisions) Ordinance.
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--- page 599 ---
2. If we or our agents exercise our discretion to reject your application:
We, the Overall Coordinators, the H Share Registrar and their respective agents and
nominees have full discretion to reject or accept any application, or to accept only part of any
application, without giving any reasons.
3. If the allocation of Hong Kong Offer Shares is void:
The allocation of Hong Kong Offer Shares will be void if the Stock Exchange does not
grant permission to list the H Shares either:
 within three weeks from the closing date of the application lists; or
 within a longer period of up to six weeks if the Stock Exchange notifies us of that
longer period within three weeks of the closing date of the application lists.
4. If:
 you make multiple applications or suspected multiple applications. Y ou may refer to
“— A. Application for Hong Kong Offer Shares — 5. Multiple Applications
Prohibited” above on what constitutes multiple applications;
 your application instruction is incomplete;
 your payment (or confirmation of funds, as the case may be) is not made correctly;
 the Underwriting Agreements do not become unconditional or are terminated; or
 the Company or the Overall Coordinators believe that by accepting your application,
it or they would violate applicable securities or other laws, rules or regulations.
5. If there is money settlement failure for allotted Shares:
Based on the arrangements between HKSCC Participants and HKSCC, HKSCC
Participants will be required to hold sufficient application funds on deposit with their
designated bank before balloting. After balloting of Hong Kong Offer Shares, the receiving
bank will collect the portion of these funds required to settle each HKSCC Participant’s actual
Hong Kong Offer Share allotment from their designated bank.
There is a risk of money settlement failure. In the extreme event of money settlement
failure by a HKSCC Participant (or its designated bank), who is acting on your behalf in
settling payment for your allotted shares, HKSCC will contact the defaulting HKSCC
Participant and its designated bank to determine the cause of failure and request such
defaulting HKSCC Participant to rectify or procure to rectify the failure.
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 600 ---
However, if it is determined that such settlement obligation cannot be met, the affected
Hong Kong Offer Shares will be reallocated to the International Offering. Hong Kong Offer
Shares applied for by you through the broker or custodian may be affected to the extent of the
settlement failure. In the extreme case, you will not be allocated any Hong Kong Offer Shares
due to the money settlement failure by such HKSCC Participant. None of us, the Relevant
Persons, the H Share Registrar and HKSCC is or will be liable if Hong Kong Offer Shares are
not allocated to you due to the money settlement failure.
D. DISPATCH/COLLECTION OF H SHARE CERTIFICATES AND REFUND OF
APPLICATION MONIES
Y ou will receive one H Share certificate for all Hong Kong Offer Shares allotted to you
under the Hong Kong Public Offering (except pursuant to applications made through the
HKSCC EIPO channel where the H Share certificates will be deposited into CCASS as
described below).
No temporary document of title will be issued in respect of the H Shares. No receipt will
be issued for sums paid on application.
The H Share certificates will only become valid evidence of title at 8:00 a.m. on the
Listing Date, which is expected to be Friday, September 19, 2025 (Hong Kong time), provided
that the Global Offering has become unconditional in all respects and the right of termination
described in “Underwriting — Underwriting Arrangements and Expenses — Hong Kong Public
Offering — Grounds for Termination” has not been exercised. Investors who trade H Shares
prior to the receipt of H Share certificates or prior to the H Share certificates becoming valid
evidence of title do so entirely at their own risk.
The right is reserved to retain any H Share certificate(s) and (if applicable) any surplus
application monies pending clearance of application monies.
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 601 ---
The following sets out the relevant procedures and time:
White Form eIPO service HKSCC EIPO channel
Dispatch/collection of H Share certificate
For physical share
certificates of
1,000,000 or more
Offer Shares
issued under your
own name /H1118/H1118/H1118/H1118/H1118/H1118
Collection in person from
the H Share Registrar,
Computershare Hong Kong
Investor Services Limited at
Shops 1712-1716, 17th
Floor, Hopewell Centre, 183
Queen’s Road East, Wan
Chai, Hong Kong.
H Share certificate(s) will
be issued in the name of
HKSCC Nominees,
deposited into CCASS
and credited to your
designated HKSCC
Participant’s stock
account.
No action by you is
required.
Time: from 9:00 a.m. to
1:00 p.m. on Friday,
September 19, 2025 (Hong
Kong time).
If you are an individual, you
must not authorize any other
person to collect for you. If
you are a corporate
applicant, your authorized
representative must bear a
letter of authorization from
your corporation stamped
with your corporation’s
chop.
Both individuals and
authorized representatives
must produce, at the time of
collection, evidence of
identity acceptable to the
H Share Registrar.
Note: If you do not collect
your H Share certificate(s)
personally within the time
above, it/they will be sent to
the address specified in your
application instructions by
ordinary post at your own
risk.
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--- page 602 ---
White Form eIPO service HKSCC EIPO channel
For physical share
certificates of less
than 1,000,000
Offer Shares
issued under your
own name /H1118/H1118/H1118/H1118/H1118/H1118
Y our H Share certificate(s)
will be sent to the address
specified in your application
instructions by ordinary post
at your own risk.
Time: Thursday, September
18, 2025
Refund mechanism for surplus application monies paid by you
Date /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Friday, September 19, 2025 Subject to the arrangement
between you and your
broker or custodian
Responsible party /H1118/H1118H Share Registrar Y our broker or custodian
Application monies
paid through
single bank
account /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
White Form e-Refund
payment instructions to your
designated bank account.
Y our broker or custodian
will arrange refund to
your designated bank
account subject to the
arrangement between you
and it.
Application monies
paid through
multiple bank
accounts /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Refund check(s) will be
dispatched to the address
specified in your application
instructions by ordinary post
at your own risk.
Except in the event of any Severe Weather Signals (as defined below) in force in Hong
Kong on Thursday, September 18, 2025 rendering it impossible for the relevant H Share
certificates to be dispatched to HKSCC in a timely manner, the Company shall procure the H
Share Registrar to arrange for delivery of the supporting documents and H Share certificates
in accordance with the contingency arrangements as agreed between them. Y ou may refer to
“— Severe Weather Arrangements” in this section.
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--- page 603 ---
E. SEVERE WEATHER ARRANGEMENTS
The application lists will not open or close on Tuesday, September 16, 2025 if there is/are:
 a tropical cyclone warning signal number 8 or above;
 a “black” rainstorm warning signal; and/or
 Extreme Conditions
(collectively, “ Severe Weather Signals ”)
in force in Hong Kong at any time between 9:00 a.m. and 12:00 noon on Tuesday, September
16, 2025 (Hong Kong time).
Instead they will open at 11:45 a.m. and/or close at 12:00 noon on the next business day
which does not have Severe Weather Signals in force in Hong Kong at any time between 9:00
a.m. and 12:00 noon (Hong Kong time).
Prospective investors should be aware that a postponement of the opening/closing of the
application lists may result in a delay in the Listing Date. Should there be any changes to the
dates mentioned in “Expected Timetable,” an announcement will be made and published on
the website of the Stock Exchange at www.hkexnews.hk and our website at www.genfleet.com
of the revised timetable.
If a Severe Weather Signal is hoisted on Thursday, September 18, 2025:
 the H Share Registrar will make appropriate arrangements for the delivery of the H
Share certificates to the CCASS Depository’s service counter so that they would be
available for trading on Friday, September 19, 2025; and
 for physical H Share certificate(s) of less than 1,000,000 Hong Kong Offer Shares
issued under your own name, dispatch will be made by ordinary post when the post
office re-opens after the Severe Weather Signal is lowered or canceled (e.g. in the
afternoon of Thursday, September 18, 2025 or on Friday, September 19, 2025).
If a Severe Weather Signal is hoisted on Friday, September 19, 2025, for physical H Share
certificate(s) of 1,000,000 Hong Kong Offer Shares or more issued under your own name, you
may collect your physical H Share certificate(s) at the H Share Registrar’s office after the
Severe Weather Signal is lowered or canceled (e.g. in the afternoon of Friday, September 19,
2025 or on Monday, September 22, 2025).
Prospective investors should be aware that if they choose to receive physical H Share
certificates issued in their own name, there may be a delay in receiving the H Share
certificates.
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--- page 604 ---
F. ADMISSION OF THE H SHARES INTO CCASS
If the Stock Exchange grants the listing of, and permission to deal in, the H Shares on the
Stock Exchange and we comply with the stock admission requirements of HKSCC, the H
Shares will be accepted as eligible securities by HKSCC for deposit, clearance and settlement
in CCASS with effect from the date of commencement of dealings in the H Shares on the Stock
Exchange or any other date HKSCC chooses. Settlement of transactions between Exchange
Participants is required to take place in CCASS on the second settlement day after any trading
day.
All activities under CCASS are subject to the General Rules of HKSCC and the HKSCC
Operational Procedures in effect from time to time.
All necessary arrangements have been made enabling the H Shares to be admitted into
CCASS.
Y ou should seek the advice of your broker or other professional advisors for details of
those settlement arrangements as such arrangements may affect your rights and interests.
G. PERSONAL DATA
The following Personal Information Collection Statement applies to any personal data
collected and held by the Company, the H Share Registrar, the receiving bank and the Relevant
Persons about you in the same way as it applies to personal data about applicants other than
HKSCC Nominees. Such personal data may include client identifier(s) and your identification
information. By giving application instructions to HKSCC, you acknowledge that you have
read, understood and agree to all of the terms of the Personal Information Collection Statement
below.
1. Personal Information Collection Statement
This Personal Information Collection Statement informs applicant for, and holder of,
Hong Kong Offer Shares, of the policies and practices of the Company and the H Share
Registrar in relation to personal data and the Personal Data (Privacy) Ordinance (Chapter 486
of the Laws of Hong Kong).
2. Reasons for the Collection of Y our Personal Data
It is necessary for applicants and registered holders of Hong Kong Offer Shares to ensure
that personal data supplied to the Company or its agents and the H Share Registrar is accurate
and up-to-date when applying for Hong Kong Offer Shares or transferring Hong Kong Offer
Shares into or out of their names or in procuring the services of the H Share Registrar.
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 595 –


--- page 605 ---
Failure to supply the requested data or supplying inaccurate data may result in your
application for Hong Kong Offer Shares being rejected, or in the delay or the inability of the
Company or the H Share Registrar to effect transfers or otherwise render their services. It may
also prevent or delay registration or transfers of Hong Kong Offer Shares which you have
successfully applied for and/or the dispatch of H Share certificate(s) to which you are entitled.
It is important that applicants for and holders of Hong Kong Offer Shares inform the
Company and the H Share Registrar immediately of any inaccuracies in the personal data
supplied.
3. Purposes
Y our personal data may be used, held, processed and/or stored (by whatever means) for
the following purposes:
 processing your application and refund check and White Form e-Refund payment
instruction(s), where applicable, verification of compliance with the terms and
application procedures set out in this Prospectus and announcing results of
allocation of Hong Kong Offer Shares;
 compliance with applicable laws and regulations in Hong Kong and elsewhere;
 registering new issues or transfers into or out of the names of the holders of the H
Shares including, where applicable, HKSCC Nominees;
 maintaining or updating the Company’s register of members;
 verifying identities of applicants for and holders of the H Shares and identifying any
duplicate applications for the H Shares;
 facilitating Hong Kong Offer Shares balloting;
 establishing benefit entitlements of holders of the H Shares, such as dividends,
rights issues, bonus issues, etc.;
 distributing communications from the Company and its subsidiaries;
 compiling statistical information and profiles of the holder of the H Shares;
 disclosing relevant information to facilitate claims on entitlements; and
 any other incidental or associated purposes relating to the above and/or to enable the
Company and the H Share Registrar to discharge their obligations to applicants for
and holders of the H Shares and/or regulators and/or any other purposes to which
applicants for and holders of the H Shares may from time to time agree.
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 596 –


--- page 606 ---
4. Transfer of Personal Data
Personal data held by the Company and the H Share Registrar relating to the applicants
for and holders of Hong Kong Offer Shares will be kept confidential but the Company and the
H Share Registrar may, to the extent necessary for achieving any of the above purposes,
disclose, obtain or transfer (whether within or outside Hong Kong) the personal data to, from
or with any of the following:
 the Company’s appointed agents such as financial advisors, receiving bank and
overseas principal share registrar;
 HKSCC or HKSCC Nominees, who will use the personal data and may transfer the
personal data to the H Share Registrar, in each case for the purposes of providing its
services or facilities or performing its functions in accordance with its rules or
procedures and operating FINI and CCASS (including where applicants for the
Hong Kong Offer Shares request a deposit into CCASS);
 any agents, contractors or third-party service providers who offer administrative,
telecommunications, computer, payment or other services to the Company or the H
Share Registrar in connection with their respective business operations;
 the Stock Exchange, the SFC and any other statutory regulatory or governmental
bodies or otherwise as required by laws, rules or regulations, including for the
purposes of the Stock Exchange’s administration of the Listing Rules and the SFC’s
performance of its statutory functions; and
 any persons or institutions with which the holders of Hong Kong Offer Shares have
or propose to have dealings, such as their bankers, solicitors, accountants or brokers
etc.
5. Retention of Personal Data
The Company and the H Share Registrar will keep the personal data of the applicants for
and holders of Hong Kong Offer Shares for as long as necessary to fulfill the purposes for
which the personal data were collected. Personal data which is no longer required will be
destroyed or dealt with in accordance with the Personal Data (Privacy) Ordinance (Chapter 486
of the Laws of Hong Kong).
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 597 –


--- page 607 ---
6. Access to and Correction of Personal Data
Applicants for and holders of Hong Kong Offer Shares have the right to ascertain whether
the Company or the H Share Registrar hold their personal data, to obtain a copy of that data,
and to correct any data that is inaccurate. The Company and the H Share Registrar have the
right to charge a reasonable fee for the processing of such requests. All requests for access to
data or correction of data should be addressed to the Company, at the Company’s registered
address disclosed in “Corporate Information” or as notified from time to time, for the attention
of the joint company secretaries, or the H Share Registrar for the attention of the privacy
compliance officer.
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 598 –


--- page 608 ---
The following is the text of a report received from the independent reporting accountants,
Ernst & Young, Certified Public Accountants, Hong Kong, prepared for the purpose of
incorporation in this Prospectus.
⭰㰟㛪姯⸒Ṳ⋀㈧
榀㸖毩歁㵳勘䙮怺979噆
⤑⏋✱ᷧ⺎27㧺
Tel 曢婘: +852 2846 9888
Fax ₚ䜆: +852 2868 4432
ey.com
Ernst & Young
27/F, One Taikoo Place
979 King’s Road
Quarry Bay, Hon
g Kong
ACCOUNTANTS’ REPORT ON HISTORICAL FINANCIAL INFORMATION TO THE
DIRECTORS OF GENFLEET THERAPEUTICS (SHANGHAI) INC. AND CITIC
SECURITIES (HONG KONG) LIMITED
Introduction
We report on the historical financial information of GENFLEET THERAPEUTICS
(SHANGHAI) INC. (the “Company”) and its subsidiaries (together, the “Group”) set out on
pages I-4 to I-68, which comprises the consolidated statements of profit or loss and other
comprehensive income, statements of changes in equity and statements of cash flows of the
Group for each of the years ended 31 December 2023 and 2024, and the four months ended
30 April 2025 (the “Relevant Periods”), and the consolidated statements of financial position
of the Group and the statements of financial position of the Company as at 31 December 2023
and 2024 and 30 April 2025 and material accounting policy information and other explanatory
information (together, the “Historical Financial Information”). The Historical Financial
Information set out on pages I-4 to I-68 forms an integral part of this report, which has been
prepared for inclusion in the prospectus of the Company dated 11 September 2025 (the
“Prospectus”) in connection with the initial listing of the shares of the Company on the Main
Board of The Stock Exchange of Hong Kong Limited (the “Stock Exchange”).
Directors’ Responsibility for the Historical Financial Information
The directors of the Company are responsible for the preparation of the Historical
Financial Information that gives a true and fair view in accordance with the basis of preparation
set out in Note 2.1 to the Historical Financial Information, and for such internal control as the
directors determine is necessary to enable the preparation of the Historical Financial
Information that is free from material misstatement, whether due to fraud or error.
Reporting Accountants’ Responsibility
Our responsibility is to express an opinion on the Historical Financial Information and to
report our opinion to you. We conducted our work in accordance with Hong Kong Standard on
Investment Circular Reporting Engagements 200 Accountants’ Reports on Historical Financial
Information in Investment Circulars issued by the Hong Kong Institute of Certified Public
Accountants (the “HKICPA”). This standard requires that we comply with ethical standards
and plan and perform our work to obtain reasonable assurance about whether the Historical
Financial Information is free from material misstatement.
APPENDIX I ACCOUNTANTS’ REPORT
– I-1 –


--- page 609 ---
Our work involved performing procedures to obtain evidence about the amounts and
disclosures in the Historical Financial Information. The procedures selected depend on the
reporting accountants’ judgement, including the assessment of risks of material misstatement
of the Historical Financial Information, whether due to fraud or error. In making those risk
assessments, the reporting accountants consider internal control relevant to the entity’s
preparation of the Historical Financial Information that gives a true and fair view in accordance
with the basis of preparation set out in note 2.1 to the Historical Financial Information in order
to design procedures that are appropriate in the circumstances, but not for the purpose of
expressing an opinion on the effectiveness of the entity’s internal control. Our work also
included evaluating the appropriateness of accounting policies used and the reasonableness of
accounting estimates made by the directors, as well as evaluating the overall presentation of
the Historical Financial Information.
We believe that the evidence we have obtained is sufficient and appropriate to provide a
basis for our opinion.
Opinion
In our opinion, the Historical Financial Information gives, for the purposes of the
accountants’ report, a true and fair view of the financial position of the Group and the Company
as at 31 December 2023 and 2024 and 30 April 2025 and of the financial performance and cash
flows of the Group for each of the Relevant Periods in accordance with the basis of preparation
set out in Note 2.1 to the Historical Financial Information.
Review of interim comparative financial information
We have reviewed the interim comparative financial information of the Group which
comprises the consolidated statement of profit or loss and other comprehensive income,
statement of changes in equity and statement of cash flows for the four months ended 30 April
2024 and other explanatory information (the “Interim Comparative Financial Information”).
The directors of the Company are responsible for the preparation and presentation of the
Interim Comparative Financial Information in accordance with the basis of preparation set out
in Note 2.1 to the Historical Financial Information. Our responsibility is to express a
conclusion on the Interim Comparative Financial Information based on our review. We
conducted our review in accordance with Hong Kong Standard on Review Engagements 2410
Review of Interim Financial Information Performed by the Independent Auditor of the Entity
issued by the HKICPA. A review consists of making inquiries, primarily of persons responsible
for financial and accounting matters, and applying analytical and other review procedures. A
review is substantially less in scope than an audit conducted in accordance with Hong Kong
Standards on Auditing and consequently does not enable us to obtain assurance that we would
become aware of all significant matters that might be identified in an audit. Accordingly, we
do not express an audit opinion. Based on our review, nothing has come to our attention that
causes us to believe that the Interim Comparative Financial Information, for the purposes of the
accountants’ report, is not prepared, in all material respects, in accordance with the basis of
preparation set out in Note 2.1 to the Historical Financial Information.
APPENDIX I ACCOUNTANTS’ REPORT
– I-2 –


--- page 610 ---
REPORT ON MATTERS UNDER THE RULES GOVERNING THE LISTING OF
SECURITIES ON THE STOCK EXCHANGE AND THE COMPANIES (WINDING UP
AND MISCELLANEOUS PROVISIONS) ORDINANCE
Adjustments
In preparing the Historical Financial Information, no adjustments to the Underlying
Financial Statements as defined on page I-4 have been made.
Dividends
We refer to Note 13 to the Historical Financial Information which states that no dividends
have been paid by the Company in respect of the Relevant Periods.
Ernst & Y oung
Certified Public Accountants
Hong Kong
11 September 2025
APPENDIX I ACCOUNTANTS’ REPORT
– I-3 –


--- page 611 ---
I. HISTORICAL FINANCIAL INFORMATION
Preparation of Historical Financial Information
Set out below is the Historical Financial Information which forms an integral part of this
accountants’ report.
The financial statements of the Group for the Relevant Periods, on which the Historical
Financial Information is based, were audited by Ernst & Y oung in accordance with Hong Kong
Standards on Auditing issued by the HKICPA (the “Underlying Financial Statements”).
The Historical Financial Information is presented in Renminbi (“RMB”) and all values
are rounded to the nearest thousand (RMB’000) except when otherwise indicated.
APPENDIX I ACCOUNTANTS’ REPORT
– I-4 –


--- page 612 ---
CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER
COMPREHENSIVE INCOME
Y ear ended 31 December Four months ended 30 April
Notes 2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
REVENUE /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185 73,734 104,703 – 82,149
Cost of sales /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(684) (20,095) – (8,693)
Gross profit /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,050 84,608 – 73,456
Other income and gains /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186 39,964 28,531 6,534 6,122
Research and development costs /H1118/H1118/H1118/H1118 (312,738) (332,124) (142,262) (69,818)
Administrative expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(49,946) (58,081) (13,881) (23,684)
Other expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188 (176) (10) (2) (3)
Finance costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11187 (1,485) (17,963) (13,615) (2,005)
Loss before change in fair value of
redemption liabilities on equity
shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(251,331) (295,039) (163,226) (15,932)
Change in fair value of redemption
liabilities on equity shares /H1118/H1118/H1118/H1118/H1118/H111825 (256,993) (382,602) (241,461) (50,692)
LOSS BEFORE TAX /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11189 (508,324) (677,641) (404,687) (66,624)
Income tax expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111812 ––––
LOSS FOR THE YEAR/PERIOD /H1118/H1118 (508,324) (677,641) (404,687) (66,624)
Attributable to:
Owners of the parent /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(508,324) (677,641) (404,687) (66,624)
OTHER COMPREHENSIVE
INCOME/(EXPENSE)
Other comprehensive income
(expense) that may be reclassified
to profit or loss in subsequent
periods:
Exchange differences on translation
of foreign operations /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118734 (1,111) (624) 470
OTHER COMPREHENSIVE
INCOME/(EXPENSE) FOR THE
YEAR/PERIOD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118734 (1,111) (624) 470
TOTAL COMPREHENSIVE LOSS
FOR THE YEAR/PERIOD /H1118/H1118/H1118/H1118/H1118 (507,590) (678,752) (405,311) (66,154)
Attributable to:
Owners of the Company /H1118/H1118/H1118/H1118/H1118/H1118/H1118(507,590) (678,752) (405,311) (66,154)
LOSS PER SHARE A TTRIBUTABLE
TO ORDINARY EQUITY
HOLDERS OF THE COMPANY
(expressed in RMB)
Basic and diluted /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814 (23.08) (26.20) (16.86) (2.49)
APPENDIX I ACCOUNTANTS’ REPORT
– I-5 –


--- page 613 ---
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
As at
31 December
As at
31 December
As at
30 April
Notes 2023 2024 2025
RMB’000 RMB’000 RMB’000
NON-CURRENT ASSETS
Property, plant and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H111815 20,601 12,328 10,325
Right-of-use assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816 23,361 15,412 14,212
Intangible assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111817 1,401 1,257 1,198
Prepayments, other receivables and
other assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819 8,275 9,576 9,730
Time deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820 31,752 – –
Total non-current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111885,390 38,573 35,465
CURRENT ASSETS
Inventories /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,058 5,586 918
Trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111818 72,353 109,153 97,518
Prepayments, other receivables and
other assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819 44,136 58,594 56,013
Time deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820 – 32,790 –
Cash and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820 332,197 362,125 390,766
Total current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118450,744 568,248 545,215
CURRENT LIABILITIES
Trade and other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821 82,847 181,733 159,406
Interest-bearing bank borrowings /H1118/H1118/H1118/H1118/H111822 5,312 51,128 85,117
Contract liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111824 101,914 42,204 12,348
Redemption liabilities on equity
shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111825 1,636,508 2,214,121 2,264,813
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816 5,526 4,243 3,345
Total current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,832,107 2,493,429 2,525,029
NET CURRENT LIABILITIES /H1118/H1118/H1118/H1118/H1118(1,381,363) (1,925,181) (1,979,814)
TOTAL ASSETS LESS CURRENT
LIABILITIES /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,295,973) (1,886,608) (1,944,349)
NON-CURRENT LIABILITIES
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816 20,835 13,977 12,861
Deferred income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823 5 0 3––
Trade and other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821 – 55,676 56,429
Total non-current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,338 69,653 69,290
Net liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,317,311) (1,956,261) (2,013,639)
DEFICIENCY IN EQUITY
Equity attributable to owners of the
Company
Paid-in capital/Share capital /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111827 22,027 26,774 26,774
Reserves /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111828 (1,339,338) (1,983,035) (2,040,413)
Controlling interests /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,317,311) (1,956,261) (2,013,639)
Net deficits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,317,311) (1,956,261) (2,013,639)
APPENDIX I ACCOUNTANTS’ REPORT
– I-6 –


--- page 614 ---
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
Y ear ended 31 December 2023
Paid-in
capital
Share
premium
Share-
based
payment
reserve
Other
reserves
Foreign
currency
translation
reserve
Accumulated
losses
Net
deficits
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At 1 January 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H111822,027 1,246,080 1,555 (1,264,082) (1,098) (851,171) (846,689)
Exchange translation
differences /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– 7 3 4 – 7 3 4
Loss for the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– – (508,324) (508,324)
Total comprehensive loss for
the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– 7 3 4 (508,324) (507,590)
Share-based payment
compensation (note 29) /H1118/H1118/H1118 – – 36,968 – – – 36,968
At 31 December 2023 /H1118/H1118/H1118/H1118/H111822,027 1,246,080 38,523 (1,264,082) (364) (1,359,495) (1,317,311)
APPENDIX I ACCOUNTANTS’ REPORT
– I-7 –


--- page 615 ---
Y ear ended 31 December 2024
Paid-in
capital/
Share
capital
Share
premium
Share-
based
payment
reserve
Other
reserves
Foreign
currency
translation
reserve
Accumulated
losses
Net
deficits
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At 1 January 2024 /H1118/H1118/H1118/H1118/H1118/H111822,027 1,246,080 38,523 (1,264,082) (364) (1,359,495) (1,317,311)
Exchange translation
differences /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– (1,111) – (1,111)
Loss for the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– – (677,641) (677,641)
Total comprehensive loss for
the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– (1,111) (677,641) (678,752)
Issue of new shares
(note 27) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,648 193,338 – – – – 195,986
Capital contributions from
employee incentive
platform (note 27) /H1118/H1118/H1118/H1118/H11182,099 9,786 – – – – 11,885
Conversion into a joint
stock company
(“Capitalisation Issue”) /H1118/H1118 – (734,351) – – – 734,351 –
Recognition of redemption
liabilities on equity shares
(note 25) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – – (195,011) – – (195,011)
Share-based payment
compensation (note 29) /H1118/H1118 – – 26,942 – – – 26,942
At 31 December 2024 /H1118/H1118/H1118/H111826,774 714,853 65,465 (1,459,093) (1,475) (1,302,785) (1,956,261)
APPENDIX I ACCOUNTANTS’ REPORT
– I-8 –


--- page 616 ---
Four months ended 30 April 2024
Paid-in
capital
Share
premium
Share-
based
payment
reserve
Other
reserves
Foreign
currency
translation
reserve
Accumulated
losses Net deficits
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At 1 January 2024 /H1118/H1118/H1118/H1118/H1118/H111822,027 1,246,080 38,523 (1,264,082) (364) (1,359,495) (1,317,311)
Exchange translation
differences /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– (624) – (624)
Loss for the period /H1118/H1118/H1118/H1118/H1118/H1118–––– – (404,687) (404,687)
Total comprehensive loss for
the period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– (624) (404,687) (405,311)
Issue of new shares
(note 27) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,648 193,338 – – – – 195,986
Capital contributions from
employee incentive
platform (note 27) /H1118/H1118/H1118/H1118/H11182,099 9,786 – – – – 11,885
Recognition of redemption
liabilities on equity shares
(note 25) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – – (195,011) – – (195,011)
Share-based payment
compensation (note 29) /H1118/H1118 – – 9,584 – – – 9,584
At 30 April 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H111826,774 1,449,204 48,107 (1,459,093) (988) (1,764,182) (1,700,178)
Four months ended 30 April 2025
Share
capital
Share
premium
Share-
based
payment
reserve
Other
reserves
Foreign
currency
translation
reserve
Accumulated
losses Net deficits
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At 1 January 2025 /H1118/H1118/H1118/H1118/H1118/H111826,774 714,853 65,465 (1,459,093) (1,475) (1,302,785) (1,956,261)
Exchange translation
differences /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– 4 7 0 – 4 7 0
Loss for the period /H1118/H1118/H1118/H1118/H1118/H1118–––– – (66,624) (66,624)
Total comprehensive loss for
the period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– 4 7 0 (66,624) (66,154)
Share-based payment
compensation (note 29) /H1118/H1118 – – 8,776 – – – 8,776
At 30 April 2025 /H1118/H1118/H1118/H1118/H1118/H1118/H111826,774 714,853 74,241 (1,459,093) (1,005) (1,369,409) (2,013,639)
APPENDIX I ACCOUNTANTS’ REPORT
– I-9 –


--- page 617 ---
CONSOLIDATED STATEMENTS OF CASH FLOWS
Y ear ended 31 December Four months ended 30 April
Notes 2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
CASH FLOWS FROM OPERA TING
ACTIVITIES
Loss before tax /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(508,324) (677,641) (404,687) (66,624)
Adjustments for:
Finance cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11187 1,485 17,963 13,615 2,005
Bank interest income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186 (10,767) (17,228) (4,186) (4,986)
Amortisation of other intangible assets /H1118/H111817 186 176 58 59
Depreciation of property, plant and
equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815 11,502 8,496 3,012 2,011
Depreciation of right-of-use assets /H1118/H1118/H1118/H111816 6,167 5,440 1,814 1,373
Share-based payment compensation /H1118/H1118/H1118/H111829 36,968 26,942 9,584 8,776
Fair value loss on redemption liabilities
on equity shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111825 256,993 382,602 241,461 50,692
Loss on the disposal of property,
plant and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188 1 3 7923
Gain on lease reassessment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186 – (488) (488) –
Fair value gains on financial assets at
FVTPL /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186 (3,587) (402) (222) –
Net exchange difference /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186 (3,818) (3,539) (959) (894)
(Increase)/decrease in trade receivables /H1118/H1118/H1118 (32,945) (36,800) 574 11,635
Decrease/(increase) in inventories /H1118/H1118/H1118/H1118/H1118/H1118 544 (3,528) 596 4,668
Decrease/(increase) in prepayments,
other receivables and other assets /H1118/H1118/H1118/H1118/H1118 14,690 (12,637) (6,905) 3,979
Increase/(decrease) in contract liabilities /H1118/H1118 14,361 (59,710) (87,554) (29,856)
Decrease in deferred income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(3,148) (503) (450) –
Increase/(decrease) in trade and
other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11187,764 148,582 94,351 (21,511)
Cash used in operating activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118(211,792) (222,266) (140,384) (38,670)
Interest received /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11189,732 15,866 3,439 4,625
Net cash flows used in operating activities /H1118 (202,060) (206,400) (136,945) (34,045)
CASH FLOWS FROM INVESTING
ACTIVITIES
Purchases of items of property, plant and
equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(594) (236) (5) (11)
Purchases for other intangible assets /H1118/H1118/H1118/H1118 – (32) – –
Purchases of financial assets at FVTPL /H1118/H1118/H1118 (480,000) (170,000) (110,000) –
Withdrawal of financial assets at FVTPL /H1118/H1118 744,024 170,402 90,222 –
APPENDIX I ACCOUNTANTS’ REPORT
– I-10 –


--- page 618 ---
Y ear ended 31 December Four months ended 30 April
Notes 2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Proceeds from disposal of property,
plant and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 344–
Proceeds from withdrawal of time deposits
with original maturity of more than
three months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 124,560 16,290 33,151
Purchases of time deposits with original
maturity of more than three months /H1118/H1118/H1118/H1118 – (123,968) (119,227) –
Net cash flows generated from/(used in)
investing activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118263,443 730 (122,716) 33,140
CASH FLOWS FROM FINANCING
ACTIVITIES
New bank borrowings /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,312 56,928 5,800 54,900
Repayment of bank borrowings /H1118/H1118/H1118/H1118/H1118/H1118/H1118(22,767) (11,112) – (21,128)
Interest paid on bank borrowings /H1118/H1118/H1118/H1118/H1118/H1118 (119) (877) (52) (401)
Principal portion of lease payments /H1118/H1118/H1118/H1118/H1118 (5,402) (5,144) (1,627) (2,187)
Interest paid for lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,366) (1,112) (389) (271)
Proceeds on issue of shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 207,871 207,871 –
Payment of listing expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (1,276) – (2,731)
Issued costs paid /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(4,717) (11,840) (6,698) –
Net cash flows (used in)/from financing
activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(29,059) 233,438 204,905 28,182
NET INCREASE/(DECREASE) IN CASH
AND CASH EQUIV ALENTS /H1118/H1118/H1118/H1118/H1118/H1118/H111832,324 27,768 (54,756) 27,277
Cash and cash equivalents at beginning of
year/period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118295,321 332,197 332,197 362,125
Effect of foreign exchange rate changes,
net /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,552 2,160 585 1,364
CASH AND CASH EQUIV ALENTS A T
END OF YEAR/PERIOD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820 332,197 362,125 278,026 390,766
ANAL YSIS OF BALANCES OF CASH
AND CASH EQUIV ALENTS
Cash and bank balances /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118332,197 255,226 278,026 308,644
Non-pledged time deposits with original
maturity of less than three months when
acquired /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 106,899 – 82,122
Cash and cash equivalents as stated in the
statement of cash flows /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118332,197 362,125 278,026 390,766
APPENDIX I ACCOUNTANTS’ REPORT
– I-11 –


--- page 619 ---
STATEMENTS OF FINANCIAL POSITION OF THE COMPANY
As at
31 December
As at
31 December
As at
30 April
Notes 2023 2024 2025
RMB’000 RMB’000 RMB’000
NON-CURRENT ASSETS
Property, plant and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H111815 18,080 10,866 9,096
Intangible assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111817 1,401 1,257 1,198
Right-of-use assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816 23,286 15,412 14,072
Investments in subsidiaries /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111830 303,526 398,352 411,740
Prepayments, other receivables and
other assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819 1,640 1,711 1,713
Amounts due from subsidiaries /H1118/H1118/H1118/H1118/H1118/H1118152,490 199,491 206,990
Time deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820 31,752 – –
Total non-current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118532,175 627,089 644,809
CURRENT ASSETS
Inventories /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,677 5,586 918
Trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111818 72,353 109,153 97,518
Prepayments, other receivables and
other assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819 9,626 39,081 35,117
Time deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820 – 32,790 –
Cash and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820 241,962 313,454 361,804
Total current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118325,618 500,064 495,357
CURRENT LIABILITIES
Interest-bearing bank borrowings /H1118/H1118/H1118/H1118/H111822 5,312 51,128 85,117
Trade and other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821 60,410 166,859 156,003
Amounts due to subsidiaries /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,548 96,548 101,048
Contract liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111824 101,914 42,204 12,348
Redemption liabilities on equity
shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111825 1,636,508 2,214,121 2,264,813
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816 5,499 4,243 3,171
Total current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,811,191 2,575,103 2,622,500
NET CURRENT LIABILITIES /H1118/H1118/H1118/H1118/H1118/H1118(1,485,573) (2,075,039) (2,127,143)
TOTAL ASSETS LESS CURRENT
LIABILITIES /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(953,398) (1,447,950) (1,482,334)
NON-CURRENT LIABILITIES
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816 20,835 13,977 12,861
Deferred income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185 0 3––
Trade and other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821 – 55,676 56,429
Total non-current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,338 69,653 69,290
Net liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(974,736) (1,517,603) (1,551,624)
EQUITY
Paid-in capital/Share capital /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111822,027 26,774 26,774
Reserves /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111828 (996,763) (1,544,377) (1,578,398)
Net deficits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(974,736) (1,517,603) (1,551,624)
APPENDIX I ACCOUNTANTS’ REPORT
– I-12 –


--- page 620 ---
II. NOTES TO THE HISTORICAL FINANCIAL INFORMATION
1. CORPORATE AND GROUP INFORMATION
GENFLEET THERAPEUTICS (SHANGHAI) INC. (the “Company”) was established in Mainland China on 23
August 2017. The registered office address of the Company is 2, 3, 4 and 5 floor, Building 8, 1206 Zhangjiang Road,
China (Shanghai) Pilot Free Trade Zone, PRC.
The Company is a clinical-stage biotechnology company. The Company and its subsidiaries (the “Group”) are
principally engaged in the research, development and commercialisation of pharmaceutical products.
As at the date of this report, the Company had direct interests in its subsidiaries, all of which are private limited
liability companies, the particulars of which are as follows:
Name
Place and date of
incorporation/
registration and place
of operations
Issued
ordinary share/
registered capital
Issued ordinary
share/registered capital
Principal activitiesDirect Indirect
Zhejiang GenFleet Therapeutics
Co., Ltd (ʮ̡)*
(note a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
PRC/Mainland China
8 April 2018
RMB60,000,000 100% – Research and
development of
innovative drugs
GenFleet Therapeutics (Hangzhou)
Co., Ltd (˙ᖹุ(ψ)ʮ̡)*
(note a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
PRC/Mainland China
26 September
2023
RMB50,000,000 100% – Technical services,
technology
development
and production
of drugs
GenFleet Therapeutics (Zhuhai)
Co., Ltd (˙ᖹุ(मऎ)ʮ̡)*
(note a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
PRC/Mainland China
1 November 2023
RMB50,000,000 100% – Technical services,
technology
development
and production
of drugs
GENFLEET THERAPEUTICS INC.
(note a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
United States 13
April 2020
United States
Dollars (“USD”)
15,000,000
100% – Research and
development of
innovative drugs
GENFLEET THERAPEUTICS
(AUSTRALIA) PTY LTD
(note a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Australia
15 July 2020
AUD100 100% – Research and
development of
innovative drugs
* These entities are limited liability enterprises established under the PRC law. The English names of
these entities represent the best effort made by the directors of the Company, as they had not been
registered with official English names.
Note:
(a) No audited financial statements have been prepared for the entities for Relevant Periods, as the entities
were not subject to any statutory audit requirements under the relevant rules and regulations in their
jurisdictions of incorporation/registration.
2.1 BASIS OF PREPARATION
The Historical Financial Information has been prepared in accordance with International Financial Reporting
Standards (“IFRSs”), which comprise all standards and interpretations approved by the International Accounting
Standards Board (the “IASB”). All IFRSs effective for the accounting period commencing from 1 January 2025,
together with the relevant transitional provisions, have been early adopted by the Group in the preparation of the
Historical Financial Information throughout the Relevant Periods.
These financial statements have been prepared under the historical cost convention, except for Redemption
liabilities on equity shares which have been measured at fair value. These financial statements are presented in
Renminbi and all values are rounded to the nearest thousand except when otherwise indicated.
APPENDIX I ACCOUNTANTS’ REPORT
– I-13 –


--- page 621 ---
The Group incurred losses continually during the Relevant Periods due to the pre-revenue stage of its new drug
research and development businesses. The Group recorded net current liabilities of RMB1,979,814,000 and net
liabilities of RMB2,013,639,000 as at 30 April 2025, primarily due to the significant amount of the redemption
liabilities on equity shares of RMB2,264,813,000 arising from the financing with redemption feature from pre-IPO
investors. The redemption liabilities on equity shares will not result in future cash payments within the next twelve
months from 30 April 2025 because as set out in the paragraph headed “Rights of the Pre-IPO Investors — HISTORY ,
DEVELOPMENT AND CORPORA TE STRUCTURE” to this prospectus, pursuant to a supplemental agreement
entered into by the Company with, among others, the then shareholders of the Company dated 26 December 2024,
the redemption feature has ceased to be effective from the date before the submission of application for an initial
public offering on the Main Board of the Stock Exchange (the “Listing”) and shall be reinstated in the event where
(i) the application of the Listing not being accepted (including being rejected or returned); (ii) the Company
withdrawing its application of the Listing; (iii) the Company failing to complete the Listing within two years after
date of the Listing Application; or (iv) the listing committee of the Stock Exchange not approving the application of
the Listing. In this regard, the directors of the Company are of the opinion that the Company is not obligated to settle
the redemption liabilities in next twelve months from 30 April 2025.
The directors of the Company further assessed whether the Group have sufficient working capital to meet its
present obligations, taking into account the financial resources available to the Group.
The Company has prudently prepared a full-speed budget based for clinical trials of its core products and other
pipelines for 2025 assuming the Company is able to raise proceeds from the listing as well as a backbone budget plan
to advance all necessary R&D activities for its core products assuming the Company is unable to raise proceeds from
the Listing. Based on the rigorous review of the budget under either full-speed or backbone scenario, the directors
of the Company are satisfied that the Group would have sufficient working capital to meet its present obligations,
taking into account the financial resources available to the Group for next twelve months from 30 April 2025.
Based on the above factors and our Group’s historical performance and our management’s operating and
financing plans, the directors of the Company concluded that it is appropriate to prepare the Historical Financial
Information on a going concern basis, which contemplates the realization of assets and settlement of liabilities in the
normal course of business.
Basis of consolidation
The Historical Financial Information includes the financial information of the Company and its subsidiaries
for the Relevant Periods. A subsidiary is an entity (including a structured entity), directly or indirectly, controlled by
the Company. Control is achieved when the Group is exposed, or has rights, to variable returns from its involvement
with the investee and has the ability to affect those returns through its power over the investee (i.e., existing rights
that give the Group the current ability to direct the relevant activities of the investee).
Generally, there is a presumption that a majority of voting rights results in control. When the Company has
less than a majority of the voting or similar rights of an investee, the Group considers all relevant facts and
circumstances in assessing whether it has power over an investee, including:
(a) the contractual arrangement with the other vote holders of the investee;
(b) rights arising from other contractual arrangements; and
(c) the Group’s voting rights and potential voting rights.
The financial statements of the subsidiaries are prepared for the same reporting periods as the Company, using
consistent accounting policies. The results of subsidiaries are consolidated from the date on which the Group obtains
control and continue to be consolidated until the date that such control ceases.
Profit or loss and each component of other comprehensive income are attributed to the owners of the parent
of the Group and to the non-controlling interests, even if this results in the non-controlling interests having a deficit
balance. All intra-group assets and liabilities, equity, income, expenses and cash flows relating to transactions
between members of the Group are eliminated in full on consolidation.
The Group reassesses whether or not it controls an investee if facts and circumstances indicate that there are
changes to one or more of the three elements of control described above. A change in the ownership interest of a
subsidiary, without a loss of control, is accounted for as an equity transaction.
If the Group loses control over a subsidiary, it derecognises the related assets (including goodwill), liabilities,
any non-controlling interest and the exchange fluctuation reserve; and recognises the fair value of any investment
retained and any resulting surplus or deficit in profit or loss. The Group’s share of components previously recognised
in other comprehensive income is reclassified to profit or loss or retained profits, as appropriate, on the same basis
as would be required if the Group had directly disposed of the related assets or liabilities.
APPENDIX I ACCOUNTANTS’ REPORT
– I-14 –


--- page 622 ---
2.2 ISSUED BUT NOT YET EFFECTIVE INTERNATIONAL FINANCIAL REPORTING STANDARDS
The Group has not applied the following new and revised IFRSs, that have been issued but are not yet effective,
in the Historical Financial Information.
IFRS 18 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Presentation and Disclosure in Financial Statements 2
IFRS 19 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Subsidiaries without Public Accountability: Disclosures 2
Amendments to IFRS 9 and IFRS 7 /H1118/H1118/H1118Amendments to the Classification and Measurement of Financial
Instruments 1
Amendments to IFRS 10 and IAS 28 /H1118/H1118Sale or Contribution of Assets between an Investor and its
Associate or Joint V enture 3
Amendments to IFRS 9 and IFRS 7 /H1118/H1118/H1118Contracts Referencing Nature-dependent Electricity
Annual Improvements to IFRS
Accounting Standards – V olume 11 /H1118/H1118
Amendments to IFRS 1, IFRS 7, IFRS 9, IFRS 10 and IAS 7 1
1 Effective for annual periods beginning on or after 1 January 2026
2 Effective for annual/reporting periods beginning on or after 1 January 2027
3 No mandatory effective date yet determined but available for adoption
The application of IFRS 18 will have no impact on the consolidated statements of financial position of the
Group, but will have impact on the presentation of the consolidated statements of profit or loss and other
comprehensive income and consolidated statements of cash flows. Except for IFRS 18, the directors of the Company
anticipate that the application of these amendments to IFRS Accounting Standards will have no material impact on
the Group’s financial performance and financial position in the foreseeable future.
2.3 MATERIAL ACCOUNTING POLICIES
Fair value measurement
The Group measures its financial instruments at fair value at the end of each reporting period. Fair value is
the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market
participants at the measurement date. The fair value measurement is based on the presumption that the transaction
to sell the asset or transfer the liability takes place either in the principal market for the asset or liability, or in the
absence of a principal market, in the most advantageous market for the asset or liability. The principal or the most
advantageous market must be accessible by the Group. The fair value of an asset or a liability is measured using the
assumptions that market participants would use when pricing the asset or liability, assuming that market participants
act in their economic best interest.
A fair value measurement of a non-financial asset takes into account a market participant’s ability to generate
economic benefits by using the asset in its highest and best use or by selling it to another market participant that
would use the asset in its highest and best use.
The Group uses valuation techniques that are appropriate in the circumstances and for which sufficient data
are available to measure fair value, maximising the use of relevant observable inputs and minimising the use of
unobservable inputs.
All assets and liabilities for which fair value is measured or disclosed in the financial statements are
categorised within the fair value hierarchy, described as follows, based on the lowest level input that is significant
to the fair value measurement as a whole:
Level 1 – based on quoted prices (unadjusted) in active markets for identical assets or liabilities
Level 2 – based on valuation techniques for which the lowest level input that is significant to the fair
value measurement is observable, either directly or indirectly
Level 3 – based on valuation techniques for which the lowest level input that is significant to the fair
value measurement is unobservable
For assets and liabilities that are recognised in the financial statement on a recurring basis, the Group
determines whether transfers have occurred between levels in the hierarchy by reassessing categorisation (based on
the lowest level input that is significant to the fair value measurement as a whole) at the end of the reporting periods.
APPENDIX I ACCOUNTANTS’ REPORT
– I-15 –


--- page 623 ---
Impairment of non-financial assets
Where an indication of impairment exists, or when annual impairment testing for an asset is required, the
asset’s recoverable amount is estimated. An asset’s recoverable amount is the higher of the asset’s or cash-generating
unit’s value in use and its fair value less costs of disposal, and is determined for an individual asset, unless the asset
does not generate cash inflows that are largely independent of those from other assets or groups of assets, in which
case the recoverable amount is determined for the cash-generating unit to which the asset belongs. In testing a
cash-generating unit for impairment, a portion of the carrying amount of a corporate asset (e.g., a headquarters
building) is allocated to an individual cash-generating unit if it can be allocated on a reasonable and consistent basis
or, otherwise, to the smallest group of cash-generating units.
An Impairment loss is recognised only if the carrying amount of an asset exceeds its recoverable amount. In
assessing value in use, the estimated future cash flows are discounted to their present value using a pre-tax discount
rate that reflects current market assessments of the time value of money and the risks specific to the asset. An
impairment loss is charged to profit or loss in the period in which it arises in those expense categories consistent with
the function of the impaired asset.
An assessment is made at the end of each reporting period as to whether there is an indication that previously
recognised impairment losses may no longer exist or may have decreased. If such an indication exists, the recoverable
amount is estimated. A previously recognised impairment loss of an asset other than goodwill is reversed only if there
has been a change in the estimates used to determine the recoverable amount of that asset, but not to an amount higher
than the carrying amount that would have been determined (net of any depreciation/amortisation) had no impairment
loss been recognised for the asset in prior years. A reversal of such an impairment loss is credited to profit or loss
in the period in which it arises unless the asset is carried at a revalued amount, in which case the reversal of the
impairment loss is accounted for in accordance with the relevant accounting policy for that revalued asset.
Related parties
A party is considered to be related to the Group if:
(a) the party is a person or a close member of that person’s family and that person
(i) has control or joint control over the Group;
(ii) has significant influence over the Group; or
(iii) is a member of the key management personnel of the Group or of a parent of the Group;
or
(b) the party is an entity where any of the following conditions applies:
(i) the entity and the Group are members of the same group;
(ii) one entity is an associate or joint venture of the other entity (or of a parent, subsidiary or fellow
subsidiary of the other entity);
(iii) the entity and the Group are joint ventures of the same third party;
(iv) one entity is a joint venture of a third entity and the other entity is an associate of the third entity;
(v) the entity is a post-employment benefit plan for the benefit of employees of either the Group or
an entity related to the Group;
(vi) the entity is controlled or jointly controlled by a person identified in (a);
(vii) a person identified in (a)(i) has significant influence over the entity or is a member of the key
management personnel of the entity (or of a parent of the entity); and
(viii) the entity, or any member of a group of which it is a part, provides key management personnel
services to the Group or to the parent of the Group.
APPENDIX I ACCOUNTANTS’ REPORT
– I-16 –


--- page 624 ---
Property, plant and equipment and depreciation
Property, plant and equipment are stated at cost less accumulated depreciation and any impairment losses. The
cost of an item of property, plant and equipment comprises its purchase price and any directly attributable costs of
bringing the asset to its working condition and location for its intended use.
Expenditure incurred after items of property, plant and equipment have been put into operation, such as repairs
and maintenance, is normally charged to profit or loss in the period in which it is incurred. In situations where the
recognition criteria are satisfied, the expenditure for a major inspection is capitalised in the carrying amount of the
asset as a replacement. Where significant parts of property, plant and equipment are required to be replaced at
intervals, the Group recognises such parts as individual assets with specific useful lives and depreciates them
accordingly.
Depreciation is calculated on the straight-line basis to write off the cost of each item of property, plant and
equipment to its residual value over its estimated useful life. The principal annual rates used for this purpose are as
follows:
Computer and office equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819% to 32%
Machinery and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819%
Motor vehicles /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819%
Leasehold improvements /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Shorter of remaining lease terms and
estimated useful lives
Where parts of an item of property, plant and equipment have different useful lives, the cost of that item is
allocated on a reasonable basis among the parts and each part is depreciated separately. Residual values, useful lives
and the depreciation method are reviewed, and adjusted if appropriate, at least at the end of the reporting periods.
An item of property, plant and equipment including any significant part initially recognised is derecognised
upon disposal or when no future economic benefits are expected from its use or disposal. Any gain or loss on disposal
or retirement recognised in profit or loss in the year the asset is derecognised is the difference between the net sales
proceeds and the carrying amount of the relevant asset.
Intangible assets (other than goodwill)
Intangible assets acquired separately are measured on initial recognition at cost. The cost of intangible assets
acquired in a business combination is the fair value at the date of acquisition. The useful lives of intangible assets
are assessed to be either finite or indefinite. Intangible assets with finite lives are subsequently amortised over the
useful economic life and assessed for impairment whenever there is an indication that the intangible asset may be
impaired. The amortisation period and the amortisation method for an intangible asset with a finite useful life are
reviewed at least at each financial year end.
Software /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111810 years
Purchased software is stated at cost less any impairment losses and is amortised on the straight-line basis over
its estimated useful life of 10 years. The estimated useful life of 10 years for software is determined by considering
the period of the economic benefits to the Group as well as by referring to the industry practice.
Research and development costs
All research costs are charged to profit or loss as incurred.
Expenditure incurred on projects to develop new products is capitalised and deferred only when the Group can
demonstrate the technical feasibility of completing the intangible asset so that it will be available for use or sale, its
intention to complete and its ability to use or sell the asset, how the asset will generate future economic benefits, the
availability of resources to complete the project and the ability to measure reliably the expenditure during the
development. Product development expenditure which does not meet these criteria is expensed when incurred.
APPENDIX I ACCOUNTANTS’ REPORT
– I-17 –


--- page 625 ---
Leases
The Group assesses at contract inception whether a contract is, or contains, a lease. A contract is, or contains,
a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for
consideration.
Group as a lessee
The Group applies a single recognition and measurement approach for all leases, except for short-term leases
and leases of low-value assets. The Group recognises lease liabilities to make lease payments and right-of-use assets
representing the right to use the underlying assets.
(a) Right-of-use assets
Right-of-use assets are recognised at the commencement date of the lease (that is the date the underlying
asset is available for use). Right-of-use assets are measured at cost, less accumulated depreciation and any
impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets
includes the amount of lease liabilities recognised, initial direct costs incurred, and lease payments made at
or before the commencement date less any lease incentives received. Right-of-use assets are depreciated on a
straight-line basis over the shorter of the lease terms and the estimated useful lives of the assets as follows:
Office premises /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182 to 10 years
If ownership of the leased asset transfers to the Group by the end of the lease term or the cost reflects
the exercise of a purchase option, depreciation is calculated using the estimated useful life of the asset.
(b) Lease liabilities
Lease liabilities are recognised at the commencement date of the lease at the present value of lease
payments to be made over the lease term. The lease payments include fixed payments (including in-substance
fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate,
and amounts expected to be paid under residual value guarantees. The lease payments also include the exercise
price of a purchase option reasonably certain to be exercised by the Group and payments of penalties for
termination of a lease, if the lease term reflects the Group exercising the option to terminate the lease.
In calculating the present value of lease payments, the Group uses its incremental borrowing rate at the
lease commencement date because the interest rate implicit in the lease is not readily determinable. After the
commencement date, the amount of lease liabilities is increased to reflect the accretion of interest and reduced
for the lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a
modification, a change in the lease term, a change in lease payments (e.g., a change to future lease payments
resulting from a change in an index or rate used to determine such lease payments) or a change in assessment
of an option to purchase the underlying asset.
The Group’s lease liabilities are presented in a separate line on the consolidated statements of financial
position.
(c) Short-term leases and leases of low-value assets
The Group applies the short-term lease recognition exemption to its short-term leases of office premises
(that is those leases that have a lease term of 12 months or less from the commencement date and do not contain
a purchase option). It also applies the recognition exemption for leases of low-value assets to leases of office
equipment that is considered to be of low value.
Lease payments on short-term leases and leases of low-value assets are recognised as an expense on a
straight-line basis over the lease term.
APPENDIX I ACCOUNTANTS’ REPORT
– I-18 –


--- page 626 ---
Investments and other financial assets
Initial recognition and measurement
Financial assets are classified, at initial recognition, as subsequently measured at amortised cost, fair value
through other comprehensive income, and fair value through profit or loss.
The classification of financial assets at initial recognition depends on the financial asset’s contractual cash
flow characteristics and the Group’s business model for managing them. With the exception of trade receivables that
do not contain a significant financing component or for which the Group has applied the practical expedient of not
adjusting the effect of a significant financing component, the Group initially measures a financial asset at its fair
value, plus in the case of a financial asset not at fair value through profit or loss, transaction costs. Trade receivables
that do not contain a significant financing component or for which the Group has applied the practical expedient are
measured at the transaction price determined under IFRS 15 in accordance with the policies set out for “Revenue
recognition” below.
In order for a financial asset to be classified and measured at amortised cost or fair value through other
comprehensive income, it needs to give rise to cash flows that are solely payments of principal and interest (“SPPI”)
on the principal amount outstanding. Financial assets with cash flows that are not SPPI are classified and measured
at fair value through profit or loss, irrespective of the business model.
The Group’s business model for managing financial assets refers to how it manages its financial assets in order
to generate cash flows. The business model determines whether cash flows will result from collecting contractual
cash flows, selling the financial assets, or both. Financial assets classified and measured at amortised cost are held
within a business model with the objective to hold financial assets in order to collect contractual cash flows, while
financial assets classified and measured at fair value through other comprehensive income are held within a business
model with the objective of both holding to collect contractual cash flows and selling. Financial assets which are not
held within the aforementioned business models are classified and measured at fair value through profit or loss.
Purchases or sales of financial assets that require delivery of assets within the period generally established by
regulation or convention in the marketplace are recognised on the trade date, that is, the date that the Group commits
to purchase or sell the asset.
Subsequent measurement
The subsequent measurement of financial assets depends on their classification as follows:
Financial assets at amortised cost (debt instruments)
Financial assets at amortised cost are subsequently measured using the effective interest method and are
subject to impairment. Gains and losses are recognised in profit or loss when the asset is derecognised, modified or
impaired.
Financial assets at fair value through profit or loss
Financial assets at fair value through profit or loss are carried in the statement of financial position at fair value
with net changes in fair value recognised in the profit or loss.
Derecognition of financial assets
A financial asset (or, where applicable, a part of a financial asset or part of a group of similar financial assets)
is primarily derecognised (i.e., removed from the Group’s consolidated statement of financial position) when:
 the rights to receive cash flows from the asset have expired; or
 the Group has transferred its rights to receive cash flows from the asset or has assumed an obligation
to pay the received cash flows in full without material delay to a third party under a “pass-through”
arrangement; and either (a) the Group has transferred substantially all the risks and rewards of the asset,
or (b) the Group has neither transferred nor retained substantially all the risks and rewards of the asset,
but has transferred control of the asset.
APPENDIX I ACCOUNTANTS’ REPORT
– I-19 –


--- page 627 ---
When the Group has transferred its rights to receive cash flows from an asset or has entered into a pass-through
arrangement, it evaluates if, and to what extent, it has retained the risk and rewards of ownership of the asset. When
it has neither transferred nor retained substantially all the risks and rewards of the asset nor transferred control of
the asset, the Group continues to recognise the transferred asset to the extent of the Group’s continuing involvement.
In that case, the Group also recognises an associated liability. The transferred asset and the associated liability are
measured on a basis that reflects the rights and obligations that the Group has retained.
Continuing involvement that takes the form of a guarantee over the transferred asset is measured at the lower
of the original carrying amount of the asset and the maximum amount of consideration that the Group could be
required to repay.
Impairment of financial assets
The Group recognises an allowance for expected credit losses (“ECLs”) for all debt instruments not held at fair
value through profit or loss. ECLs are based on the difference between the contractual cash flows due in accordance
with the contract and all the cash flows that the Group expects to receive, discounted at an approximation of the
original effective interest rate. The expected cash flows will include cash flows from the sale of collateral held or
other credit enhancements that are integral to the contractual terms.
General approach
ECLs are recognised in two stages. For credit exposures for which there has not been a significant increase
in credit risk since initial recognition, ECLs are provided for credit losses that result from default events that are
possible within the next 12 months (a 12-month ECL). For those credit exposures for which there has been a
significant increase in credit risk since initial recognition, a loss allowance is required for credit losses expected over
the remaining life of the exposure, irrespective of the timing of the default (a lifetime ECL).
At the end of each reporting period, the Group assesses whether the credit risk on a financial instrument has
increased significantly since initial recognition. When making the assessment, the Group compares the risk of a
default occurring on the financial instrument as at the reporting date with the risk of a default occurring on the
financial instrument as at the date of initial recognition and considers reasonable and supportable information that
is available without undue cost or effort, including historical and forward-looking information. The Group considers
that there has been a significant increase in credit risk when contractual payments are more than 30 days past due.
The Group considers a financial asset in default when contractual payments are 90 days past due. However,
in certain cases, the Group may also consider a financial asset to be in default when internal or external information
indicates that the Group is unlikely to receive the outstanding contractual amounts in full before taking into account
any credit enhancements held by the Group. A financial asset is written off when there is no reasonable expectation
of recovering the contractual cash flows.
Financial assets at amortised cost are subject to impairment under the general approach and they are classified
within the following stages for measurement of ECLs except for trade receivables which apply the simplified
approach as detailed below.
Stage 1 – Financial instruments for which credit risk has not increased significantly since initial
recognition and for which the loss allowance is measured at an amount equal to 12-month
ECLs.
Stage 2 – Financial instruments for which credit risk has increased significantly since initial
recognition but that are not credit-impaired financial assets and for which the loss
allowance is measured at an amount equal to lifetime ECLs.
Stage 3 – Financial assets that are credit-impaired at the reporting date (but that are not purchased or
originated credit-impaired) and for which the loss allowance is measured at an amount
equal to lifetime ECLs.
APPENDIX I ACCOUNTANTS’ REPORT
– I-20 –


--- page 628 ---
Simplified approach
For trade receivables that do not contain a significant financing component or when the Group applies the
practical expedient of not adjusting the effect of a significant financing component, the Group applies the simplified
approach in calculating ECLs. Under the simplified approach, the Group does not track changes in credit risk, but
instead recognises a loss allowance based on lifetime ECLs at each reporting date. The Group has established a
general matrix that is based on its historical credit loss experience, adjusted for forward-looking factors specific to
the debtors and the economic environment.
Financial liabilities
Initial recognition and measurement
Financial liabilities are classified, at initial recognition, as financial liabilities at fair value through profit or
loss, loans and borrowings, payables, or as derivatives designated as hedging instruments in an effective hedge, as
appropriate.
All financial liabilities are recognised initially at fair value and, in the case of payables, net of directly
attributable transaction costs.
The Group’s financial liabilities include trade and other payables, interest-bearing bank borrowings and
redemption liabilities on equity shares.
Subsequent measurement
The subsequent measurement of financial liabilities depends on their classification as follows:
Financial liabilities at amortised cost
After initial recognition, trade and other payables and interest-bearing bank borrowings are subsequently
measured at amortised cost, using the effective interest rate method unless the effect of discounting would be
immaterial, in which case they are stated at cost. Gains and losses are recognised in profit or loss when the liabilities
are derecognised as well as through the effective interest rate amortisation process.
Amortised cost is calculated by taking into account any discount or premium on acquisition and fees or costs
that are an integral part of the effective interest rate. The effective interest rate amortisation is included in finance
costs in profit or loss.
Financial liabilities measured at FVTPL
Financial liabilities measured at FVTPL include redemption liabilities on equity shares.
Financial liabilities designated upon initial recognition as at fair value through profit or loss are designated at
the initial date of recognition, and only if the criteria in IFRS 9 are satisfied. Gains or losses on liabilities designated
at FVTPL are recognised in profit or loss, except for the gains or losses arising from the Group’s own credit risk
which are presented in other comprehensive income with no subsequent reclassification to the profit or loss. The net
fair value gain or loss recognised in the profit or loss does not include any interest charged on these financial
liabilities.
Derecognition of financial liabilities
A financial liability is derecognised when the obligation under the liability is discharged or cancelled, or
expires.
When an existing financial liability is replaced by another from the same lender on substantially different
terms, or the terms of an existing liability are substantially modified, such an exchange or modification is treated as
a derecognition of the original liability and a recognition of a new liability, and the difference between the respective
carrying amounts is recognised in profit or loss.
APPENDIX I ACCOUNTANTS’ REPORT
– I-21 –


--- page 629 ---
Offsetting of financial instruments
Financial assets and financial liabilities are offset and the net amount is reported in the statement of financial
position if there is a currently enforceable legal right to offset the recognised amounts and there is an intention to
settle on a net basis, or to realise the assets and settle the liabilities simultaneously.
Inventories
Inventories are stated at the lower of cost and net realizable value. Cost is determined on the first-in, first-out
basis or on a weighted average method and, in the case of work in progress and finished goods, comprises direct
materials, direct labour and an appropriate proportion of overheads. Net realisable value is based on estimated selling
prices less any estimated costs to be incurred to completion and disposal.
Cash and cash equivalents
Cash and cash equivalents in the statement of financial position comprise cash on hand and at banks, and short
term highly liquid deposits with a maturity of generally within three months that are readily convertible into known
amounts of cash, subject to an insignificant risk of changes in value and held for the purpose of meeting short-term
cash commitments.
For the purpose of the consolidated statement of cash flows, cash and cash equivalents comprise cash on hand
and at banks, and short-term deposits as defined above, less bank overdrafts which are repayable on demand and form
an integral part of the Group’s cash management.
Provisions
A provision is recognised when a present obligation (legal or constructive) has arisen as a result of a past event
and it is probable that a future outflow of resources will be required to settle the obligation, provided that a reliable
estimate can be made of the amount of the obligation.
If Group has a contract that is onerous, the present obligation under the contract will be recognised and
measured as a provision.
Income tax
Income tax comprises current and deferred tax. Income tax relating to items recognised outside profit or loss
is recognised outside profit or loss, either in other comprehensive income or directly in equity.
Current tax assets and liabilities are measured at the amount expected to be recovered from or paid to the
taxation authorities, based on tax rates (and tax laws) that have been enacted or substantively enacted by the end of
the reporting periods, taking into consideration interpretations and practices prevailing in the countries in which the
Group operates.
Deferred tax is provided, using the liability method, on all temporary differences at the end of the reporting
periods between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes.
Deferred tax liabilities are recognised for all taxable temporary differences, except:
 when the deferred tax liability arises from the initial recognition of an asset or liability in a transaction
that is not a business combination and, at the time of the transaction, affects neither the accounting profit
nor taxable profit or loss and does not give rise to equal taxable and deductible temporary difference;
and
 in respect of taxable temporary differences associated with investments in subsidiaries, when the timing
of the reversal of the temporary differences can be controlled and it is probable that the temporary
differences will not reverse in the foreseeable future.
APPENDIX I ACCOUNTANTS’ REPORT
– I-22 –


--- page 630 ---
Deferred tax assets are recognised for all deductible temporary differences, and the carry forward of unused
tax credits and any unused tax losses. Deferred tax assets are recognised to the extent that it is probable that taxable
profit will be available against which the deductible temporary differences, and the carry forward of unused tax
credits and unused tax losses can be utilised, except:
 when the deferred tax asset relating to the deductible temporary differences arises from the initial
recognition of an asset or liability in a transaction that is not a business combination and, at the time
of the transaction, affects neither the accounting profit nor taxable profit or loss and does not give rise
to equal taxable and deductible temporary difference; and
 in respect of deductible temporary differences associated with investments in subsidiaries, deferred tax
assets are only recognised to the extent that it is probable that the temporary differences will reverse in
the foreseeable future and taxable profit will be available against which the temporary differences can
be utilised.
The carrying amount of deferred tax assets is reviewed at the end of the reporting periods and reduced to the
extent that it is no longer probable that sufficient taxable profit will be available to allow all or part of the deferred
tax asset to be utilised. Unrecognised deferred tax assets are reassessed at the end of the reporting periods and are
recognised to the extent that it has become probable that sufficient taxable profit will be available to allow all or part
of the deferred tax asset to be recovered.
Deferred tax assets and liabilities are measured at the tax rates that are expected to apply to the period when
the asset is realised or the liability is settled, based on tax rates (and tax laws) that have been enacted or substantively
enacted by the end of the reporting periods.
Deferred tax assets and deferred tax liabilities are offset if and only if the Group has a legally enforceable right
to set off current tax assets and current tax liabilities and the deferred tax assets and deferred tax liabilities relate to
income taxes levied by the same taxation authority on either the same taxable entity or different taxable entities which
intend either to settle current tax liabilities and assets on a net basis, or to realise the assets and settle the liabilities
simultaneously, in each future period in which significant amounts of deferred tax liabilities or assets are expected
to be settled or recovered.
Government grants
Government grants are recognised at their fair value where there is reasonable assurance that the grant will be
received and all attaching conditions will be complied with. When the grant relates to an expense item, it is
recognised as income on a systematic basis over the periods that the costs, for which it is intended to compensate,
are expensed.
Where the grant relates to an asset, the fair value is credited to a deferred income account and is released to
the statement of profit or loss over the expected useful life of the relevant asset by equal annual instalments or
deducted from the carrying amount of the asset and released to the statement of profit or loss by way of a reduced
depreciation charge.
Revenue recognition
Revenue from contracts with customers
Revenue from contracts with customers is recognised when control of the goods or services is transferred to
the customer at an amount that reflects the consideration to which the Group expects to be entitled in exchange for
those goods or services.
When the consideration in a contract includes a variable amount, the amount of consideration is estimated to
which the Group will be entitled in exchange for transferring the goods or services to the customer. The variable
consideration is estimated at contract inception and constrained until it is highly probable that a significant revenue
reversal in the amount of cumulative revenue recognised will not occur when the associated uncertainty with the
variable consideration is subsequently resolved.
The Group’s revenue is generated from the collaboration agreements with Innovent Biologics, Inc. and
SELLAS Life Sciences Group, Inc., which generally contain multiple performance obligations including (1) grants
of licenses to intellectual property rights and (2) the research and development services.
APPENDIX I ACCOUNTANTS’ REPORT
– I-23 –


--- page 631 ---
Collaboration revenue
At contract inception, the Group analyses the collaboration arrangements to assess whether they are within the
scope of IFRS 11 Joint Arrangements to determine whether such arrangements involve joint operating activities
performed by parties that are both active participants in the activities and are exposed to significant risks and rewards
dependent on the commercial success of such activities. After Group’s assessment, no collaboration arrangement was
within the scope of IFRS11 Joint Arrangements during the Relevant Periods.
In determining the appropriate amount of revenue to be recognised as the Group fulfils its obligations under
each of the collaboration agreements, the management of the Company perform the five-step model under IFRS 15.
The collaboration arrangements may contain more than one unit of account or performance obligation, including
grants of licenses to intellectual property rights (the “Licenses”), agreements to provide research and development
services and other deliverables. The collaborative arrangements typically do not include a right of return for any
deliverable. In general, the consideration allocated to each performance obligation is recognised when the obligation
is satisfied either by delivering a good or rendering a service, limited to the consideration that is not constrained.
Non-refundable payments received before all of the relevant criteria for revenue recognition are satisfied are recorded
as contract liabilities.
(a) Licenses of intellectual property
Upfront non-refundable payments for Licenses are evaluated to determine if they are distinct from the other
performance obligations identified in the arrangements. For the Licenses determined to be distinct, the Group
recognises revenues from non-refundable up-front fees allocated to the licenses at a point in time, when the Licenses
are transferred to the licensee and the licensee is able to use and benefit from the Licenses.
Milestone payments
At the inception of each arrangement that includes development milestone payments and commercial
milestone payments, the management of the Company evaluates whether the milestones are considered
probable of being reached and estimates the amount to be included in the transaction price using the most
likely amount method. If it is probable that a significant revenue reversal would not occur, the associated
milestone value is included in the transaction price. Milestones related to development-based activities may
include initiation of various phases of clinical trials. Due to the uncertainty involved in meeting these
development-based targets, they are generally fully constrained at contract inception. The management of the
Company assesses whether the variable consideration is fully constrained for each reporting period based on
the facts and circumstances surrounding the clinical trials. Upon changes to constraint associated with the
developmental milestones, variable consideration is included in the transaction price when a significant
reversal of revenue recognised is not expected to occur and allocated to the separate performance obligations.
Due to the inherent uncertainty with the approval process, regulatory milestones are fully constrained until the
period in which those regulatory approvals are achieved. Regulatory milestones are included in the transaction
price in the period regulatory approval is obtained.
Royalties
For arrangements that include sales-based royalties, the Group recognises revenue when the related
sales occur.
(b) Research and development services
The Group provides a customer with a project team of scientists and technical staff dedicated to the customer’s
studies for a specific period of time and charges the customer at a fixed rate per employee and the Group has assessed
that the customer simultaneously receives and consumes benefit provided by the Group’s performances. Therefore,
the performance obligation of research and development services is satisfied over time and revenue is recognised over
the service period.
(c) Drug supply manufacturing services
The Group provides drug supply manufacturing services to customers and the Group recognises revenue at
point in time when such services are rendered. The drug supply manufacturing services revenue is recognised on a
net basis as the Group is acting as an agent because the Group didn’t obtain control of those drugs goods before they
are transferred to the customers.
APPENDIX I ACCOUNTANTS’ REPORT
– I-24 –


--- page 632 ---
Other income
Bank interest income is recognised on an accrual basis using the effective interest method by applying the rate
that exactly discounts the estimated future cash receipts over the expected life of the financial instrument or a shorter
period, when appropriate, to the net carrying amount of the financial asset.
Contract liabilities
A contract liability is recognised when a payment is received or a payment is due (whichever is earlier) from
a customer before the Group transfers the related goods or services. Contract liabilities are recognised as revenue
when the Group performs under the contract (i.e., transfers control of the related goods or services to the customer).
Share-based payments
The Group operates restricted share units schemes. Employees (including directors) of the Group receive
remuneration in the form of share-based payments, whereby employees render services in exchange for equity
instruments (“equity-settled transactions”). The cost of equity-settled transactions with employees is measured by
reference to the fair value at the date at which they are granted. The fair value is determined by an external valuer,
further details of which are set out in Note 29 to the Historical Financial Information.
The cost of equity-settled transactions is recognised in employee benefit expense, together with a
corresponding increase in equity, over the period in which the performance and/or service conditions are fulfilled.
The cumulative expense recognised for equity-settled transactions at the end of each reporting period until the vesting
date reflects the extent to which the vesting period has expired and the Group’s best estimate of the number of equity
instruments that will ultimately vest. The charge or credit to the statement of profit or loss for a period represents
the movement in the cumulative expense recognised as at the beginning and end of that period.
Service and non-market performance conditions are not taken into account when determining the grant date
fair value of awards, but the likelihood of the conditions being met is assessed as part of the Group’s best estimate
of the number of equity instruments that will ultimately vest. Market performance conditions are reflected within the
grant date fair value. Any other conditions attached to an award, but without an associated service requirement, are
considered to be non-vesting conditions. Non-vesting conditions are reflected in the fair value of an award and lead
to an immediate expensing of restricted shares unless there are also service and/or performance conditions.
For awards that do not ultimately vest because non-market performance and/or service conditions have not
been met, no expense is recognised. Where awards include a market or non-vesting condition, the transactions are
treated as vesting irrespective of whether the market or non-vesting condition is satisfied, provided that all other
performance and/or service conditions are satisfied.
Where the terms of an equity-settled award are modified, as a minimum an expense is recognised as if the
terms had not been modified, if the original terms of the award are met. In addition, an expense is recognised for any
modification that increases the total fair value of the share-based payments, or is otherwise beneficial to the employee
as measured at the date of modification. Where an equity-settled award is cancelled, it is treated as if it had vested
on the date of cancellation, and any expense not yet recognised for the award is recognised immediately.
Other employee benefits
Pension schemes
The employees of the Group which operates in Mainland China are required to participate in a central pension
scheme operated by the local municipal government. The subsidiaries operating in Mainland China are required to
contribute a certain percentage of their payroll costs to the central pension scheme. The contributions are charged to
profit or loss as they become payable in accordance with the rules of the central pension scheme.
The subsidiary in the United States maintains multiple qualified contributory savings plans as allowed under
Section 401(k) of the Internal Revenue Code in the US. These plans are defined contribution plans covering
substantially all its qualifying employees of that subsidiary and provide for voluntary contributions by employees,
subject to certain limits. The contributions are made by both the employees and the employer. The employees’
contributions are primarily based on specified dollar amounts or percentages of employee compensation. The only
obligation of the subsidiaries in the US with respect to the retirement benefit plans is to make the specified
contributions under the plans.
APPENDIX I ACCOUNTANTS’ REPORT
– I-25 –


--- page 633 ---
Housing fund — Mainland China
The Group contributes on a monthly basis to a defined contribution housing fund plan operated by the local
municipal government. Contributions to this plan by the Group are expensed as incurred.
Borrowing costs
All borrowing costs are recognised in profit or loss in the period in which they are incurred.
Foreign currencies
The Historical Financial Information is presented in RMB, which is the Company’s functional currency. Each
entity in the Group determines its own functional currency and items included in the financial statements of each
entity are measured using that functional currency. Foreign currency transactions recorded by the entities in the
Group are initially recorded using their respective functional currency rates prevailing at the dates of the transactions.
Monetary assets and liabilities denominated in foreign currencies are translated at the functional currency rates of
exchange ruling at the end of the reporting periods. Differences arising on settlement or translation of monetary items
are recognised in profit or loss.
Non-monetary items that are measured in terms of historical cost in a foreign currency are translated using the
exchange rates at the dates of the initial transactions. Non-monetary items measured at fair value in a foreign currency
are translated using the exchange rates at the date when the fair value was measured. The gain or loss arising on
translation of a non-monetary item measured at fair value is treated in line with the recognition of the gain or loss
on change in fair value of the item (i.e., translation difference on the item whose fair value gain or loss is recognised
in other comprehensive income or profit or loss is also recognised in other comprehensive income or profit or loss,
respectively).
In determining the exchange rate on initial recognition of the related asset, expense or income on the
derecognition of a non-monetary asset or non-monetary liability relating to an advance consideration, the date of
initial transaction is the date on which the Group initially recognises the non-monetary asset or non-monetary liability
arising from the advance consideration. If there are multiple payments or receipts in advance, the Group determines
the transaction date for each payment or receipt of the advance consideration.
The functional currencies of certain overseas subsidiaries are currencies other than RMB. As at the end of the
Relevant Periods, the assets and liabilities of these entities are translated into RMB at the exchange rates prevailing
at the end of the reporting periods and their statements of profit or loss and other comprehensive income are
translated into RMB at the exchange rates that approximate to those prevailing at the dates of the transactions.
The resulting exchange differences are recognised In other comprehensive income and accumulated in the
exchange fluctuation reserve. On disposal of a foreign operation, the cumulative amount in the reserve relating to that
particular foreign operation is recognised in profit or loss.
For the purpose of the consolidated statement of cash flows, the cash flows of the overseas subsidiaries are
translated into RMB at the exchange rates ruling at the dates of the cash flows. Frequently recurring cash flows of
the overseas subsidiaries which arise throughout the reporting periods are translated into RMB at the exchange rates
that approximate to those prevailing at the dates of the transactions.
APPENDIX I ACCOUNTANTS’ REPORT
– I-26 –


--- page 634 ---
3. SIGNIFICANT ACCOUNTING JUDGEMENTS AND ESTIMATES
The preparation of the Group’s Historical Financial Information requires management to make judgements,
estimates and assumptions that affect the reported amounts of revenues, expenses, assets and liabilities, and their
accompanying disclosures, and the disclosure of contingent liabilities. Uncertainty about these assumptions and
estimates could result in outcomes that could require a material adjustment to the carrying amounts of the assets or
liabilities affected in the future.
Judgements
In the process of applying the Group’s accounting policies, management has made the following judgements,
apart from those involving estimations, which have the most significant effect on the amounts recognised in the
Historical Financial Information:
Research and development costs
All research costs are charged to profit or loss as incurred. Expenses incurred on each pipeline to develop new
products are only capitalised and deferred in accordance with the accounting policy for research and development
expenses in Note 2.3 to the Historical Financial Information. Determining the amounts to be capitalised requires
management to make judgements on the technical feasibility of existing pipelines to be successfully commercialised
and bring economic benefits to the Company.
Estimation uncertainty
The key assumptions concerning the future and other key sources of estimation uncertainty at the end of the
reporting periods, that have a significant risk of causing a material adjustment to the carrying amounts of assets and
liabilities within the next financial year, are described below.
Leases — Estimating the incremental borrowing rate
The Group cannot readily determine the interest rate implicit in a lease, and therefore, it uses an incremental
borrowing rate (“IBR”) to measure lease liabilities. The Group estimates the IBR using observable inputs (such as
market interest rates) when available and is required to make certain entity-specific estimates (such as a subsidiary’s
stand-alone credit rating).
Impairment of property, plant and equipment, intangible assets and right-of-use assets
At the end of each reporting period, the Group reviews the carrying amounts of its property, plant and
equipment, intangible assets and right-of-use assets to determine whether there is any indication that these assets have
suffered an impairment loss. If any such indication exists, the recoverable amount of the relevant asset is estimated
in order to determine the extent of the impairment loss.
The recoverable amount of property, plant and equipment, intangible assets and right-of-use assets are
estimated individually. When it is not possible to estimate the recoverable amount individually, the Group estimates
the recoverable amount of the cash-generating unit to which the asset belongs. Recoverable amount is the higher of
fair value less costs of disposal and value in use. In assessing value in use, the estimated future cash flows are
discounted to their present value using a pre-tax discount rate that reflects current market assessments of the time
value of money and the risks specific to the asset (or a cash-generating unit) for which the estimates of future cash
flows have not been adjusted. If the recoverable amount of an asset (or a cash-generating unit) is estimated to be less
than its carrying amount, the carrying amount of the asset (or a cash-generating unit) is reduced to its recoverable
amount. An impairment loss is recognized immediately in profit or loss.
Group assess whether there are any indicators of impairment for all non-financial assets (including property,
plant and equipment, intangible assets and right-of-use assets) at the end of each period comprising the Relevant
Periods by reviewing the internal and external sources of information.
As of 31 December 2023 and 2024 and 30 April 2025, no indicators of impairment for non-financial assets of
the Group were identified, given that (i) non-financial assets of the Group were neither obsolete nor physically
damaged, and (ii) Group actual losses incurred for the years ended 31 December 2023 and 2024 and the four months
ended 30 April 2025 did not exceed the estimated losses for the same periods.
APPENDIX I ACCOUNTANTS’ REPORT
– I-27 –


--- page 635 ---
Fair value of financial instruments
The redemption liabilities on equity shares issued by the Group are not traded in an active market and the
respective fair value is determined by using valuation techniques, including the back-solve method. Such valuation
is based on key parameters about risk-free rate, discounts for lack of marketability (“DLOM”) and volatility, which
are subject to uncertainty and might materially differ from the actual results.
The fair values of redemption liabilities on equity shares of the Group as at 31 December 2023 and 2024 and
30 April 2025 were RMB1,636,508,000, RMB2,214,121,000, and RMB2,264,813,000, respectively. Further details
are set out in Note 25 to the Historical Financial Information.
Recognition of income taxes and deferred tax assets
Determining income tax provision involves judgment on the future tax treatment of certain transactions and
when certain matters relating to the income taxes have not been confirmed by the local tax bureau. Management
evaluates tax implications of transactions and tax provisions are set up accordingly. The tax treatments of such
transactions are reconsidered periodically to take into account all changes in tax legislation. Deferred tax assets are
recognised in respect of deductible temporary differences and unused tax losses. As those deferred tax assets can only
be recognised to the extent that it is probable that future taxable profits will be available against which the deductible
temporary differences and the losses can be utilised, management’s judgment is required to assess the probability of
future taxable profits. Management’s assessment is revised as necessary and deferred tax assets are recognised if it
becomes probable that future taxable profits will allow the deferred tax asset to be recovered.
Share-based payment expenses
The Group estimates the number of share awards contingently issuable when determining the share-based
expenses, which depends on the achievement of certain non-market performance targets of the Group under the
Employee Incentive Scheme (as defined in Note 29 to the Historical Financial Information). This requires an
estimation of the performance targets to be achieved by the Group, including completion of public offering. The
Group recorded RMB36,968,000, RMB26,942,000 and RMB8,776,000 share-based payment compensation expenses
during the Relevant Periods.
4. OPERATING SEGMENT INFORMATION
Operating segment information
The Group is engaged in biopharmaceutical research and development, which is regarded as a single reportable
segment in a manner consistent with the way in which information is reported internally to the Group’s directors for
purposes of resource allocation and performance assessment. Therefore, no further operating segment analysis
thereof is presented.
Geographical information
(a) Revenue from external customers
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Overseas /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,955 – – 77,618
Mainland China /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111871,779 104,703 – 4,531
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,734 104,703 – 82,149
The revenue information above is based on the locations of headquarters of the Group’s customers.
APPENDIX I ACCOUNTANTS’ REPORT
– I-28 –


--- page 636 ---
(b) Non-current assets
Since all of the Group’s non-current assets were located in Mainland China, no geographical information in
accordance with IFRS 8 Operating Segments is presented.
Information about major customers
Revenue from one customer (2023: two), which accounted for 100% of the Group’s revenue during the year
end 31 December 2024 and 2023, and revenue from two major customers which accounted for 99.73% of the Group’s
revenue during the four months ended 30 April 2025, is set out below:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Customer A /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,95 5–––
Customer B /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111871,779 104,703 – 4,310
Customer C /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – – 77,618
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,734 104,703 – 81,928
5. REVENUE
An analysis of revenue is as follows:
Revenue from contracts with customers
(a) Disaggregated revenue information
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Type of services
Licenses of intellectual property /H1118/H1118/H1118 71,779 90,035 – 80,742
Sale of goods /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 14,668 – 127
Research and development services /H1118 1,955 – – 1,280
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,734 104,703 – 82,149
Timing of revenue recognition
Transferred at a point in time /H1118/H1118/H1118/H1118/H111871,779 104,703 – 80,869
Transferred overtime /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,955 – – 1,280
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,734 104,703 – 82,149
(b) Performance obligations
Information about the Group’s performance obligations is summarised below:
License-out of GFH925
On 1 September 2021, the Group entered into a license and option agreement (the “GFH925 License
Agreement”) with Innovent Biologics, Inc. (“Innovent”). According to the GFH925 License Agreement, the
Group grant to Innovent (i) an exclusive, royalty-bearing and sublicensable license to develop and
commercialize GFH925 for the treatment, prevention or diagnosis of any disease in humans in Mainland
China, Hong Kong, Macau and Taiwan (the “Greater China”); and (ii) an exclusive option (the “Ex-China
Option”) to develop and commercialize GFH925 in the all countries and regions in the world other than Greater
China (the “Ex-China Territory”).
APPENDIX I ACCOUNTANTS’ REPORT
– I-29 –


--- page 637 ---
In November 2021, Innovent paid the Group a one-time and non-refundable upfront payment of
USD8,500,000 (equivalent to RMB55,126,000) for GFH925 license in Great China, and an ex-China Option
payment of USD13,500,000 (equivalent to RMB87,553,000). The Group recognised collaboration revenue
related to GFH925 of RMB55,126,000 during the year ended 31 December 2021 and recorded contract liability
of RMB87,553,000 as of 31 December 2021.
In December 2022, Innovent paid the Group a development milestone payment of USD5,000,000
(equivalent to RMB35,884,000) for the first patient dosed in the first pivotal trial in Great China for the
licensed product. According to the agreement of the development milestone payment, the Group recognised
revenue of licenses of intellectual property related to GFH925 of RMB35,884,000 during the year ended 31
December 2022.
In 2023, Innovent paid the Group a development milestone payment of USD10,000,000 (equivalent to
RMB71,779,000) for the NDA filing completed in Great China for the first indication for the licensed products.
According to the agreement of the development milestone payment, the Group recognised revenue of licenses
of intellectual property related to GFH925 of RMB71,779,000 during the year ended 31 December 2023.
In January 2024, the Group entered into a supplementary agreement with Innovent to terminate the
Ex-China Option under the GFH925 License Agreement. Subject to the terms and conditions of the agreement,
the group is required to pay non-refundable termination fees of USD20,000,000 in instalments and certain
revenue sharing payments to Innovent based on the annual net sales of GFH925 outside Great China.
Following the termination, the Group took back Ex-China option and has the exclusive rights to develop and
commercialize the licensed product and the licensed compounds for any indication in the Ex-China Territory.
As of 30 April 2025, the Group had paid USD2,000,000 (equivalent to RMB14,165,000) to Innovent. The
remaining USD18,000,000 will be paid by the Group to Innovent in instalments by 1 December 2026.
During the four months ended 30 April 2025, the Group didn’t recognised any milestone revenue of
GFH925.
License-out of GFH009
In March 2022, the Group entered into an exclusive license agreement with Sellas Life Sciences Group,
Inc. (“Sellas”), to use, have used, develop, have developed, manufacture, have manufactured, commercialize.
have commercialized, and otherwise Exploit Compounds and Products in the world outside of Greater China.
Pursuant to the Agreement, the Group is entitled to receive upfront payment, development milestone payments,
commercial Milestone payments. Details of the agreement please refer to “BUSINESS” to this prospectus.
Sellas paid the Group a non-creditable and non-refundable initial payment of USD4,500,000 (equivalent to
RMB28,567,000) and USD5,500,000 (equivalent to RMB39,144,000) in 2022 and 2023, respectively. The
Group recognised revenue of licenses of intellectual property related to GFH009 of RMB68,040,000 during the
year ended 31 December 2022, and recognised trade receivables of RMB38,305,000 at the end of 31 December
2022, which had been fully collected in 2023.
License-out of GFH375
In August 2023, the Group entered into a collaboration and option agreement (the “V erastem
Agreement”) with V erastem, Inc. (“V erastem”), a pharmaceutical company headquartered in Massachusetts and
listed on Nasdaq (stock code: VSTM). V erastem specializes in developing treatment for cancers and is a
member of Nasdaq Biotechnology Index.
Under the V erastem Agreement, the Group granted V erastem options to obtain an exclusive,
royalty-bearing and sublicensable licenses to develop, manufacture, commercialize and otherwise exploit the
certain compounds and products in territories other than Greater China. As the V erastem Agreement implicates
three programs, V erastem obtained three options from the Group and the exercise of option is on a
program-by-program basis. V erastem paid the Group the upfront payments of USD2,000,000 (equivalent to
RMB14,360,000) and USD3,500,000 (equivalent to RMB24,893,000) for the options of three product
candidates, including GFH375 in 2023 and 2024, respectively. Therefore, the upfront payment received from
V erastem was presented as contract liabilities as of 31 December 2023 and 2024. In January 2025, V erastem
exercised one of three options and the Group recognised RMB77,618,000 revenue related to GFH375 during
four months ended 30 April 2025.
APPENDIX I ACCOUNTANTS’ REPORT
– I-30 –


--- page 638 ---
The amounts of transaction prices allocated to the remaining performance obligations (unsatisfied or
partially unsatisfied) as at 31 December are as follow:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Amounts expected to be
recognised as revenue:
Within one year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111887,554 32,631 – –
After one year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814,360 9,573 14,360 12,348
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118101,914 42,204 14,360 12,348
The amounts of transaction prices allocated to the remaining performance obligations which are
expected to be recognised as revenue after one year relate to the exercise of the option, of which the
performance obligations are to be satisfied within two years. All the other amounts of transaction prices
allocated to the remaining performance obligations are expected to be recognised as revenue within one year.
The amounts disclosed above do not include variable consideration which is constrained.
6. OTHER INCOME AND GAINS
An analysis of other income and gains is as follows:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Other income
Government grants /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,786 6,869 678 242
Bank interest income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111810,767 17,228 4,186 4,986
Gains
Foreign exchange differences, net /H1118/H1118 3,818 3,539 959 894
Fair value gains on financial assets
at FVTPL /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,587 402 222 –
Gain on lease reassessment /H1118/H1118/H1118/H1118/H1118/H1118– 488 488 –
Others /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118651–
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111839,964 28,531 6,534 6,122
7. FINANCE COSTS
An analysis of finance costs is as follows:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Interest on lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H11181,366 1,112 389 271
Imputed interest expenses on other
payable /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 4,134 1,334 1,116
Transaction cost on issue of
redemption liabilities on equity
shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 11,840 11,840 –
Interest on bank borrowings /H1118/H1118/H1118/H1118/H1118/H1118119 877 52 618
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,485 17,963 13,615 2,005
APPENDIX I ACCOUNTANTS’ REPORT
– I-31 –


--- page 639 ---
8. OTHER EXPENSES
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Loss on disposals of property, plant
and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 3 7923
Others /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183 91––
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118176 10 2 3
9. LOSS BEFORE TAX
The Group’s loss before tax is arrived at after charging/(crediting):
Y ear ended 31 December Four months ended 30 April
Notes 2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Cost of inventories sold /H1118/H1118/H1118/H1118 – 7,670 – 8,098
Cost of licenses of intellectual
property /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 12,425 – 595
Cost of services provided /H1118/H1118/H1118 6 8 4–––
Depreciation of property,
plant and equipment* /H1118/H1118/H1118/H111815 11,502 8,496 3,012 2,011
Amortisation of intangible
assets*** /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111817 186 176 58 59
Depreciation of right-of-use
assets** /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816 6,167 5,440 1,814 1,373
Gain on lease reassessment /H1118/H1118 6 – (488) (488) –
Expenses relating to short-
term and low-value leases /H1118 16 1,540 961 375 387
Listing expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118 – 18,363 – 9,228
Staff costs (including
directors’ emoluments):
– Salaries, discretionary
bonuses, allowances and
benefits in kind /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111884,058 78,321 24,732 22,883
– Pension scheme
contributions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,750 5,709 1,968 1,863
– Share-based payment
compensation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111829 36,968 26,942 9,584 8,776
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118126,776 110,972 36,284 33,522
* The depreciation of property, plant and equipment for the Relevant Periods is included in “Research and
development costs” and “Administrative expenses” in the consolidated statements of profit or loss.
** The depreciation of right-of-use assets for the Relevant Periods is included in “Research and
development costs” and “Administrative expenses” in the consolidated statements of profit or loss.
*** The amortisation of intangible assets for the Relevant Periods is included in “Research and development
costs” and “Administrative expenses” in the consolidated statements of profit or loss.
APPENDIX I ACCOUNTANTS’ REPORT
– I-32 –


--- page 640 ---
10. DIRECTORS’ AND SUPERVISORS’ REMUNERATION
Directors’ and supervisors’ remuneration for the Relevant Periods, disclosed pursuant to the Listing Rules,
section 383(1)(a), (b), (c) and (f) of the Hong Kong Companies Ordinance and Part 2 of the Companies (Disclosure
of Information about Benefits of Directors) Regulation, is as follows:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Salaries, allowances and
benefits in kind /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814,238 13,302 4,124 4,755
Performance related bonuses /H1118/H1118/H1118/H1118/H11188,647 9,942 1,898 1,707
Pension scheme contributions /H1118/H1118/H1118/H1118/H1118210 241 72 115
Equity-settled share award expense /H1118 33,548 9,386 3,752 3,222
Total fees and other emoluments /H1118/H1118/H1118 56,643 32,871 9,846 9,799
Directors and supervisors:
Salaries,
allowances and
benefits in kind
Performance
related bonuses
Pension scheme
contributions
Share-based
payment
compensation Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Y ear ended 31 December
2023
Directors:
Dr. Lu Qiang (Note a) /H1118/H1118/H1118 1,310 1,444 – 16,785 19,539
Dr. Lan Jiong (Note b) /H1118/H1118/H1118 1,447 1,444 – 14,305 17,196
Mr. Li Bin (Note c) /H1118/H1118/H1118/H1118/H1118–––––
Mr. Zhou Yi (Note d) /H1118/H1118/H1118/H1118 –––––
Ms. Shen Haige (Note e) /H1118/H1118 2,505 1,142 70 406 4,123
Mr. Wang Y u (Note f) /H1118/H1118/H1118/H11184,305 2,780 70 1,104 8,259
Mr. Stephen Hui Wang
(Note g) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Mr. Song Gaoguang
(Note h) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Mr. Zhu Jingyang (Note i) /H1118 –––––
Mr. Li Jingrong (Note j) /H1118/H1118 2,762 841 – 697 4,300
Mr. Chen Fanwei (Note k) /H1118 1,074 290 – – 1,364
Mr. Peng Wei (Note l) /H1118/H1118/H1118 –––––
Ms. Qian Ranting
(Note m) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Ms. Liu Dan (Note o) /H1118/H1118/H1118 –––––
Supervisors:
Ms. Zhang Wei (Note q) /H1118/H1118 835 706 70 251 1,862
Mr. Wei Y ufa (Note r) /H1118/H1118/H1118 –––––
Mr. Xue Mengjun
(Note s) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814,238 8,647 210 33,548 56,643
APPENDIX I ACCOUNTANTS’ REPORT
– I-33 –


--- page 641 ---
Salaries,
allowances and
benefits in kind
Performance
related bonuses
Pension scheme
contributions
Share-based
payment
compensation Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Y ear ended 31 December
2024
Directors:
Dr. Lu Qiang (Note a) /H1118/H1118/H1118 998 1,663 – – 2,661
Dr. Lan Jiong (Note b) /H1118/H1118/H1118 998 1,665 – – 2,663
Mr. Zhou Yi (Note d) /H1118/H1118/H1118/H1118 –––––
Ms. Shen Haige (Note e) /H1118/H1118 2,505 1,030 73 1,562 5,170
Mr. Wang Y u (Note f) /H1118/H1118/H1118/H11184,306 2,597 73 4,355 11,331
Mr. Song Gaoguang
(Note h) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Mr. Zhu Jingyang (Note i) /H1118 –––––
Mr. Li Jingrong (Note j) /H1118/H1118 2,763 1,673 – 2,322 6,758
Mr. Chen Fanwei (Note k) /H1118 802 803 – – 1,605
Mr. Peng Wei (Note l) /H1118/H1118/H1118 –––––
Ms. Qian Ranting
(Note m) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Mr. Gao Jieliang (Note n) /H1118 –––––
Ms. Liu Dan (Note o) /H1118/H1118/H1118 –––––
Mr. Liu Erh Fei (Note p) /H1118/H1118 –––––
Ms. Tao Sha (Note v) /H1118/H1118/H1118/H1118 –––––
Ms. Zhang Wei (Note q) /H1118/H1118 139 111 12 190 452
Ms. Xu Xijin (Note w) /H1118/H1118/H1118 –––––
Supervisors:
Ms. Zhang Wei (Note q) /H1118/H1118 488 388 42 665 1,583
Mr. Wei Y ufa (Note r) /H1118/H1118/H1118 –––––
Mr. Xue Mengjun
(Note s) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Ms. Ma Rui (Note t) /H1118/H1118/H1118/H1118108 4 17 165 294
Mr. Lin Chonglan
(Note u) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118195 8 24 127 354
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111813,302 9,942 241 9,386 32,871
APPENDIX I ACCOUNTANTS’ REPORT
– I-34 –


--- page 642 ---
Salaries,
allowances and
benefits in kind
Performance
related bonuses
Pension scheme
contributions
Share-based
payment
compensation Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Four months ended
30 April 2024
(unaudited)
Directors:
Dr. Lu Qiang (Note a) /H1118/H1118/H1118 161 554 – – 715
Dr. Lan Jiong (Note b) /H1118/H1118/H1118 161 555 – – 716
Mr. Zhou Yi (Note d) /H1118/H1118/H1118/H1118 –––––
Ms. Shen Haige (Note e) /H1118/H1118 835 157 24 625 1,641
Mr. Wang Y u (Note f) /H1118/H1118/H1118/H11181,436 366 24 1,742 3,568
Mr. Song Gaoguang
(Note h) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Mr. Zhu Jingyang (Note i) /H1118 –––––
Mr. Li Jingrong (Note j) /H1118/H1118 921 210 – 929 2,060
Mr. Chen Fanwei (Note k) /H1118 3 3 1––– 3 3 1
Mr. Peng Wei (Note l) /H1118/H1118/H1118 –––––
Ms. Qian Ranting
(Note m) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Mr. Gao Jieliang (Note n) /H1118 –––––
Ms. Liu Dan (Note o) /H1118/H1118/H1118 –––––
Mr. Liu Erh fei (Note p) /H1118/H1118 –––––
Supervisors:
Ms. Zhang Wei (Note q) /H1118/H1118 279 56 24 456 815
Mr. Wei Y ufa (Note r) /H1118/H1118/H1118 –––––
Mr. Xue Mengjun
(Note s) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,124 1,898 72 3,752 9,846
Salaries,
allowances and
benefits in kind
Performance
related bonuses
Pension scheme
contributions
Share-based
payment
compensation Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Four months ended
30 April 2025
Directors:
Dr. Lu Qiang (Note a) /H1118/H1118/H1118 497 421 – – 918
Dr. Lan Jiong (Note b) /H1118/H1118/H1118 497 421 – – 918
Mr. Zhou Yi (Note d) /H1118/H1118/H1118/H1118 –––––
Ms. Shen Haige (Note e) /H1118/H1118 834 129 24 520 1,507
Mr. Wang Y u (Note f) /H1118/H1118/H1118/H11181,434 492 24 1,451 3,401
Mr. Song Gaoguang
(Note h) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Mr. Zhu Jingyang (Note i) /H1118 –––––
Mr. Li Jingrong (Note j) /H1118/H1118 920 224 – 774 1,918
Ms. Qian Ranting
(Note m) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Ms. Tao Sha (Note v) /H1118/H1118/H1118/H1118 –––––
Ms. Zhang Wei (Note q) /H1118/H1118 275 10 24 380 689
Ms. Xu Xijin (Note w) /H1118/H1118/H1118 –––––
Supervisors:
Mr. Xue Mengjun
(Note s) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––
Ms. Ma Rui (Note t) /H1118/H1118/H1118/H1118105 3 19 55 182
Mr. Lin Chonglan
(Note u) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118193 7 24 42 266
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,755 1,707 115 3,222 9,799
APPENDIX I ACCOUNTANTS’ REPORT
– I-35 –


--- page 643 ---
Notes:
(a) Dr. Lu Qiang was appointed as a director of the Company on November 2017.
(b) Dr. Lan Jiong was appointed as a director of the Company with effect from November 2017.
(c) Mr. Li Bin was appointed as a director of the Company with effect from October 2018 and has resigned
as a director of the Company with effect from July 2023.
(d) Mr. Zhou Yi was appointed as a director of the Company with effect from February 2020.
(e) Ms. Shen Haige was appointed as a director of the Company with effect from December 2020.
(f) Mr. Wang Y u was appointed as a director of the Company with effect from December 2020.
(g) Mr. Stephen Hui Wang was appointed as a director of the Company with effect from December 2020 and
has resigned as a director of the Company with effect from July 2023.
(h) Mr. Song Gaoguang was appointed as a director of the Company with effect from December 2020.
(i) Mr. Zhu Jingyang was appointed as a director of the Company with effect from August 2022.
(j) Mr. Li Jingrong was appointed as a director of the Company with effect from March 2022.
(k) Mr. Chen Fanwei was appointed as a director of the Company with effect from March 2022 and resigned
in November 2024.
(l) Mr. Peng Wei was appointed as a director of the Company with effect from July 2023 and resigned in
July 2024.
(m) Ms. Qian Ranting was appointed as a director of the Company with effect from July 2023.
(n) Mr. Gao Jieliang was appointed as a director of the Company with effect from May 2024 and resigned
in November 2024.
(o) Ms. Liu Dan was appointed as a director of the Company with effect from February 2020 and has
resigned as a director of the Company with effect from May 2024.
(p) Mr. Liu Erh Fei was appointed as a director of the Company with effect from January 2024 and resigned
in December 2024.
(q) Ms. Zhang Wei was appointed as a supervisor of the Company with effect from February 2020 and
resigned in July 2024. Ms. Zhang Wei was appointed as a director of the Company with effect from
November 2024.
(r) Mr. Wei Y ufa was appointed as a supervisor of the Company with effect from February 2020 and
resigned in July 2024.
(s) Mr. Xue Mengjun was appointed as a supervisor of the Company with effect from August 2022.
(t) Ms Ma Rui was appointed as a supervisor of the Company with effect from September 2024.
(u) Mr. Lin Chonglan was appointed as a supervisor of the Company with effect from September 2024.
(v) Ms. Tao Sha was appointed as a director of the Company with effect from November 2024.
(w) Ms. Xu Xijin was appointed as a director of the Company with effect from July 2024.
During the Relevant Period, restricted shares were granted to the non-director and non-chief executive highest
paid employees in respect of their services to the Group, further details of which are included in the disclosures in
Note 29 to the Historical Financial Information. The fair value of such restricted share units, which has been
recognised in profit or loss over the vesting period, was determined as at the date of grant and the amount included
in the Historical Financial Information for the Relevant Periods is included in the above non-director and non-chief
executive highest paid employees’ remuneration disclosures.
During the Relevant Period, no highest paid employees waived or agreed to waive any remuneration, and no
remuneration was paid by the Group to any of the five highest paid employees as an inducement to join or upon
joining the Group or as compensation for loss of office.
APPENDIX I ACCOUNTANTS’ REPORT
– I-36 –


--- page 644 ---
11. FIVE HIGHEST PAID EMPLOYEES
The five highest paid employees during the Relevant Period, included five, three and five directors, details of
whose remuneration are set out in Note 10 above. Details of the remuneration of the remaining highest paid
employees who are neither a director nor chief executive of the Company are as follows:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Salaries, allowances and
benefits in kind /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 2,827 1,368 –
Performance related bonuses /H1118/H1118/H1118/H1118/H1118 – 1,353 104 –
Pension scheme contributions /H1118/H1118/H1118/H1118/H1118 – 140 672 –
Equity-settled share award expense /H1118 – 6,034 71 –
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 10,354 2,215 –
The numbers of non-director and non-chief executive highest paid employees whose remuneration fell within
the following bands are as follows:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
Number of
employees
Number of
employees
Number of
employees
Number of
employees
(unaudited)
HKD500,001 to HKD1,000,000 /H1118/H1118/H1118 ––1–
HKD1,000,001 to HKD1,500,000 /H1118/H1118 ––1–
HKD4,500,001 to HKD5,500,000 /H1118/H1118 –1––
HKD5,500,001 to HKD6,500,000 /H1118/H1118 –1––
During the Relevant Periods, no highest paid employees waived or agreed to waive any remuneration and no
remuneration was paid by the Group to any of the five highest paid employees as an inducement to join or upon
joining the Group or as compensation for loss of office.
12. INCOME TAX
The Group is subject to income tax on an entity basis on profits arising in or derived from the jurisdictions
in which members of the Group are domiciled and operate.
Mainland China
Under the Law of the PRC on Enterprise Income Tax (the “EIT Law”) and Implementation Regulation of the
EIT Law, the Enterprise Income Tax (“EIT”) rate of the PRC subsidiaries was 25% during the Relevant Periods except
for certain members of the Group which was subject to tax concession set out below.
The Company was accredited as a “High and New Technology Enterprise” (“HNTE”) in 2022. Therefore, the
Company was entitled to a preferential EIT rate of 15% during the Relevant Periods. The qualification as a HNTE
is subject to review by the relevant tax authority in the PRC every three years.
In 2022, the Ministry of Finance and the State Administration of Taxation issued the Notice on the Further
Implementation of Preferential Income Tax for Small and Micro Enterprises (Cai Shui [2022] No. 13), which provides
that the portion of annual taxable income of small and micro enterprises exceeding RMB1,000,000 but not exceeding
RMB3,000,000 shall be deducted to 25% of the taxable income and subject to income tax at a rate of 20% for the
period from 1 January 2022 to 31 December 2027. Zhejiang GenFleet Therapeutics Co., Ltd., GenFleet Therapeutics
(Beijing) Co., Ltd. and GenFleet Biopharmaceutical (Shanghai) Co., Ltd. were recognised as Small and Micro
Enterprises and were entitled to a preferential tax rate of 20% during the Relevant Periods.
Pursuant to Cai Shui [2018] circular No. 76, the Company and Zhejiang GenFleet Therapeutics Co., Ltd. which
was accredited as “Technology-based Small and Medium-sized Enterprises” can carry forward their unutilised tax
losses for up to ten years. This extension of the expiration period applies to all the unutilised tax losses that were
carried forward by the entities at the effective date of the tax circular.
APPENDIX I ACCOUNTANTS’ REPORT
– I-37 –


--- page 645 ---
Australia
The subsidiary incorporated and operated in Australia with turnover of less than AUD50,000,000 was subject
to income tax at the rate of 25% on the estimated assessable profits during the Relevant Periods.
USA
The subsidiary incorporated and operated in United States of America is subject to the federal corporate
income tax rate at 21% during the Relevant Periods.
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Loss before tax /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(508,324) (677,641) (404,687) (66,624)
Tax at the statutory tax rate (15%) /H1118/H1118 (76,249) (101,646) (60,703) (9,994)
Effect of different tax rates enacted
by local authorities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5,833) (5,358) (1,998) (1,290)
Additional deductible allowance for
research and development
expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(34,871) (32,719) (10,796) (7,351)
Tax losses utilised from previous
periods /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(196) – – –
Income not subject to tax /H1118/H1118/H1118/H1118/H1118/H1118/H1118(2,488) (474) – –
Deductible temporary difference and
tax losses not recognised /H1118/H1118/H1118/H1118/H1118/H111873,435 78,115 35,246 9,834
Expenses not deductible for tax /H1118/H1118/H1118 46,202 62,082 38,251 8,801
Tax charge at the Group’s effective
rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118––––
Deferred tax assets have not been recognised in respect of these losses and deductible temporary differences
as the Company and its subsidiaries have been loss-making for some time and it is not considered probable that
taxable profits in foreseeable future will be available against which the tax losses can be utilised.
According to the EIT Law, an additional 100% of qualified research and development expenses incurred is
allowed to be deducted from taxable income effective from 1 October 2022 for GenFleet Biopharmaceutical
(Shanghai) Co., Ltd, while Zhejiang GenFleet Therapeutics Co., Ltd. has been eligible for this additional deduction
since 1 January 2022.
13. DIVIDENDS
No dividend was paid or declared by the Company during the Relevant Periods.
14. LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE COMPANY
On 29 September 2024, the Company was converted to a joint stock limited liability company. A total of
26,774,063 shares of par value of RMB1.00 each were issued and allotted to the respective shareholders of the
Company according to the paid-in capital registered under these shareholders on that day. The conversion of paid-in
capital to share capital with par value of RMB1.00 each is applied retrospectively for the Relevant Periods and four
months ended 30 April 2024 for the purpose of computation of basic earnings per share.
The calculation of the basic loss per share amounts is based on the loss for the year attributable to ordinary
equity holders of the parent, and the weighted average numbers of ordinary shares in issue during the Relevant
Periods and four months ended 30 April 2024. The calculation of the basic loss per share amounts didn’t consider
the sub-division of the Shares by the Company, where the Company subdivided its Share from one Share of RMB1.0
each into ten Shares of RMB0.1 each, which will become effective immediately prior to the Listing.
The Group had no potentially dilutive ordinary shares in issue during the Relevant Periods and four months
ended 30 April 2024.
APPENDIX I ACCOUNTANTS’ REPORT
– I-38 –


--- page 646 ---
The calculation of basic and loss per share is based on:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Loss
Loss attributable to ordinary equity
holders of the parent /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(508,324) (677,641) (404,687) (66,624)
Shares
Weighted average number of
ordinary shares in issue during the
year/period used in the basic loss
per share calculation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111822,027,034 25,859,402 24,007,405 26,774,063
LOSS PER SHARE A TTRIBUTABLE
TO ORDINARY EQUITY
HOLDERS OF THE PARENT
(Express in RMB) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
– Basic and diluted /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(23.08) (26.20) (16.86) (2.49)
15. PROPERTY, PLANT AND EQUIPMENT
The Group
Machinery and
equipment
Computer and
office
equipment Motor Vehicles
Leasehold
improvements Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
31 December 2023
At 1 January 2023:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111838,884 5,690 1,276 12,851 58,701
Accumulated depreciation /H1118 (14,012) (3,378) (458) (9,457) (27,305)
Net carrying amount /H1118/H1118/H1118/H111824,872 2,312 818 3,394 31,396
At 1 January 2023, net
of accumulated
depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111824,872 2,312 818 3,394 31,396
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118547 169 – 141 857
Disposal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(88) (62) – – (150)
Depreciation provided
during the year /H1118/H1118/H1118/H1118/H1118/H1118(7,519) (1,139) (243) (2,601) (11,502)
At 31 December 2023, net
of accumulated
depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111817,812 1,280 575 934 20,601
At 31 December 2023:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111839,229 5,688 1,276 12,992 59,185
Accumulated depreciation (21,417) (4,408) (701) (12,058) (38,584)
Net carrying amount /H1118/H1118/H1118/H111817,812 1,280 575 934 20,601
APPENDIX I ACCOUNTANTS’ REPORT
– I-39 –


--- page 647 ---
Machinery and
equipment
Computer and
office
equipment Motor Vehicles
Leasehold
improvements Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
31 December 2024:
At 1 January 2024:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111839,229 5,688 1,276 12,992 59,185
Accumulated depreciation /H1118 (21,417) (4,408) (701) (12,058) (38,584)
Net carrying amount /H1118/H1118/H1118/H111817,812 1,280 575 934 20,601
At 1 January 2024, net of
accumulated
depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111817,812 1,280 575 934 20,601
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111833 2 – 201 236
Disposal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(2) (11) – – (13)
Depreciation provided
during the year /H1118/H1118/H1118/H1118/H1118/H1118(6,424) (695) (242) (1,135) (8,496)
At 31 December 2024, net
of accumulated
depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111811,419 576 333 – 12,328
At 31 December 2024:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111839,221 5,578 1,276 13,523 59,598
Accumulated depreciation /H1118 (27,802) (5,002) (943) (13,523) (47,270)
Net carrying amount /H1118/H1118/H1118/H111811,419 576 333 – 12,328
Machinery and
equipment
Computer and
office
equipment Motor Vehicles
Leasehold
improvements Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
30 April 2025
At 1 January 2025:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111839,221 5,578 1,276 13,523 59,598
Accumulated depreciation /H1118 (27,802) (5,002) (943) (13,523) (47,270)
Net carrying amount /H1118/H1118/H1118/H111811,419 576 333 – 12,328
At 1 January 2025,
net of accumulated
depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111811,419 576 333 – 12,328
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 1––– 1 1
Disposal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(3) – – – (3)
Depreciation provided
during the period /H1118/H1118/H1118/H1118/H1118(1,846) (84) (81) – (2,011)
At 30 April 2025,
net of accumulated
depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11189,581 492 252 – 10,325
At 30 April 2025:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111839,225 5,575 1,276 13,195 59,271
Accumulated depreciation /H1118 (29,644) (5,083) (1,024) (13,195) (48,946)
Net carrying amount /H1118/H1118/H1118/H11189,581 492 252 – 10,325
As at 31 December 2023 and 2024 and 30 April 2025, there were no pledged property, plant and equipment.
APPENDIX I ACCOUNTANTS’ REPORT
– I-40 –


--- page 648 ---
The Company
Machinery and
equipment
Computer and
office
equipment Motor Vehicles
Leasehold
improvements Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
31 December 2023
At 1 January 2023:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111833,456 5,094 1,276 11,085 50,911
Accumulated depreciation /H1118 (11,967) (3,058) (458) (7,692) (23,175)
Net carrying amount /H1118/H1118/H1118/H111821,489 2,036 818 3,393 27,736
At 1 January 2023, net of
accumulated
depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,489 2,036 818 3,393 27,736
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118484 168 – 128 780
Disposal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(51) (50) – – (101)
Depreciation provided
during the year /H1118/H1118/H1118/H1118/H1118/H1118(6,481) (1,014) (243) (2,597) (10,335)
At 31 December 2023, net
of accumulated
depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815,441 1,140 575 924 18,080
At 31 December 2023:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111833,792 5,109 1,276 11,213 51,390
Accumulated depreciation /H1118 (18,351) (3,969) (701) (10,289) (33,310)
Net carrying amount /H1118/H1118/H1118/H111815,441 1,140 575 924 18,080
Machinery and
equipment
Computer and
office
equipment Motor Vehicles
Leasehold
improvements Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
31 December 2024
At 1 January 2024:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111833,792 5,109 1,276 11,213 51,390
Accumulated depreciation /H1118 (18,351) (3,969) (701) (10,289) (33,310)
Net carrying amount /H1118/H1118/H1118/H111815,441 1,140 575 924 18,080
At 1 January 2024, net of
accumulated
depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815,441 1,140 575 924 18,080
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182 2 – 202 206
Disposal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(2) (10) – – (12)
Depreciation provided
during the year /H1118/H1118/H1118/H1118/H1118/H1118(5,448) (592) (242) (1,126) (7,408)
At 31 December 2024, net
of accumulated
depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11189,993 540 333 – 10,866
At 31 December 2024:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111833,752 5,001 1,276 11,745 51,774
Accumulated depreciation /H1118 (23,759) (4,461) (943) (11,745) (40,908)
Net carrying amount /H1118/H1118/H1118/H11189,993 540 333 – 10,866
APPENDIX I ACCOUNTANTS’ REPORT
– I-41 –


--- page 649 ---
Machinery and
equipment
Computer and
office
equipment Motor Vehicles
Leasehold
improvements Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
30 April 2025
At 1 January 2025:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111833,752 5,001 1,276 11,745 51,774
Accumulated depreciation /H1118 (23,759) (4,461) (943) (11,745) (40,908)
Net carrying amount /H1118/H1118/H1118/H11189,993 540 333 – 10,866
At 1 January 2025,
net of accumulated
depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11189,993 540 333 – 10,866
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 0––– 1 0
Depreciation provided
during the period /H1118/H1118/H1118/H1118/H1118(1,620) (79) (81) – (1,780)
At 30 April 2025,
net of accumulated
depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,383 461 252 – 9,096
At 30 April 2025:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111833,762 5,001 1,276 – 40,039
Accumulated depreciation /H1118 (25,379) (4,540) (1,024) – (30,943)
Net carrying amount /H1118/H1118/H1118/H11188,383 461 252 – 9,096
As at 31 December 2023 and 2024 and 30 April 2025, there were no pledged property, plant and equipment.
16. LEASES
The Group as a lessee
The Group has lease contracts for various items of office premises used in its operations. Leases of office
premises generally have lease terms between 2 and 10 years. Generally, the Group is restricted from assigning and
subleasing the leased assets outside the Group.
(a) Right-of-use assets
The carrying amounts of the Group’s right-of-use assets and the movements during the Relevant Periods are
as follows:
Office premises
RMB’000
As at 31 December 2023
As at 1 January 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111829,528
Depreciation charge /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(6,167)
As at 31 December 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,361
APPENDIX I ACCOUNTANTS’ REPORT
– I-42 –


--- page 650 ---
Office premises
RMB’000
As at 31 December 2024
As at 1 January 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,361
Depreciation charge /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5,440)
Lease reassessment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(2,509)
As at 31 December 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815,412
Office premises
RMB’000
As at 30 April 2025
As at 1 January 2025 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815,412
Addition /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118173
Depreciation charge /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,373)
As at 30 April 2025 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814,212
(b) Lease liabilities
The carrying amount of lease liabilities and the movements during the Relevant Periods are as follows:
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Carrying amount at 1 January /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,763 26,361 18,220
New leases /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 173
Accretion of interest recognised during
the year/period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,366 1,112 271
Payments /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(6,768) (6,256) (2,458)
Lease reassessment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (2,997) –
Carrying amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111826,361 18,220 16,206
Analysed into:
Current portion /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,526 4,243 3,345
Non-current portion /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820,835 13,977 12,861
The maturity analysis of lease liabilities is disclosed in Note 36 to the Historical Financial Information.
(c) The amounts recognised in profit or loss in relation to leases are as follows:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Depreciation of right-of-use assets /H1118/H1118 6,167 5,440 1,814 1,373
Interest on lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H11181,366 1,112 389 271
Gain on lease reassessment /H1118/H1118/H1118/H1118/H1118/H1118– (488) (488) –
Expenses relating to short-term and
low-value leases /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,540 961 375 387
Total amount recognised in
profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11189,073 7,025 2,090 2,031
APPENDIX I ACCOUNTANTS’ REPORT
– I-43 –


--- page 651 ---
(d) The total cash outflow for leases is disclosed in Note 31 to the Historical Financial Information.
The Company as a lessee
The Company has lease contracts for various items of office premises used in its operations. Leases of office
premises generally have lease terms between 3 and 10 years. Generally, the Company is restricted from assigning and
subleasing the leased assets outside the Company.
(a) Right-of-use assets
The carrying amounts of the Group’s right-of-use assets and the movements during the Relevant Periods are
as follows:
Office premises
RMB’000
As at 31 December 2023
As at 1 January 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111829,363
Depreciation charge /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(6,077)
As at 31 December 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,286
Office premises
RMB’000
As at 31 December 2024
As at 1 January 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,286
Depreciation charge /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5,365)
Lease reassessment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(2,509)
As at 31 December 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815,412
Office premises
RMB’000
As at 30 April 2025
As at 1 January 2025 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815,412
Depreciation charge /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,340)
As at 30 April 2025 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814,072
(b) Lease liabilities
The carrying amounts of lease liabilities and the movements during the Relevant Periods are as follows:
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Carrying amount at 1 January /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,574 26,334 18,220
Accretion of interest recognised during the
year/period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,361 1,111 270
Payments /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(6,601) (6,228) (2,458)
Lease reassessment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (2,997) –
Carrying amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111826,334 18,220 16,032
Analysed into:
Current portion /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,499 4,243 3,171
Non-current portion /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111820,835 13,977 12,861
The maturity analysis of lease liabilities is disclosed in Note 36 to the Historical Financial Information.
APPENDIX I ACCOUNTANTS’ REPORT
– I-44 –


--- page 652 ---
(c) The amounts recognised in profit or loss in relation to leases are as follows:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Depreciation of right-of-use assets /H1118/H1118 6,077 5,365 1,814 1,340
Interest on lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H11181,361 1,111 389 270
Lease reassessment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (488) (489) –
Expenses relating to short-term and
low-value leases /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,500 943 375 369
Total amount recognised in
profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,938 6,931 2,089 1,979
17. INTANGIBLE ASSETS
The Group and the Company
Software
RMB’000
31 December 2023
At 1 January 2023:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,567
Accumulated amortisation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(167)
Net carrying amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,400
At 1 January 2023, net of accumulated amortisation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,400
Addition /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118187
Amortisation provided during the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(186)
At 31 December 2023, net of accumulated amortisation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,401
At 31 December 2023:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,754
Accumulated amortisation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(353)
Net carrying amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,401
Software
RMB’000
31 December 2024
At 1 January 2024:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,754
Accumulated amortisation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(353)
Net carrying amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,401
At 1 January 2024, net of accumulated amortisation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,401
Addition /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111832
Amortisation provided during the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(176)
At 31 December 2024, net of accumulated amortisation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,257
At 31 December 2024:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,786
Accumulated amortisation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(529)
Net carrying amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,257
APPENDIX I ACCOUNTANTS’ REPORT
– I-45 –


--- page 653 ---
Software
RMB’000
30 April 2025
At 1 January 2025:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,786
Accumulated amortisation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(529)
Net carrying amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,257
At 1 January 2025, net of accumulated amortisation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,257
Addition /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–
Amortisation provided during the period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(59)
At 30 April 2025, net of accumulated amortisation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,198
At 30 April 2025:
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,786
Accumulated amortisation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(588)
Net carrying amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,198
18. TRADE RECEIV ABLE
The Group
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
Impairment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
The Company
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
Impairment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
The Group’s trading terms with its customers are mainly on credit. The credit period is generally 30 to 60 days,
depending on the contract terms. Each customer has a maximum credit limit. The Group does not hold any collateral
or other credit enhancements over its trade receivable balances. Trade receivables are non-interest-bearing.
APPENDIX I ACCOUNTANTS’ REPORT
– I-46 –


--- page 654 ---
The Group
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Within 1 year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
The Company
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Within 1 year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
An impairment analysis is performed at each reporting date. The Group has applied the simplified approach
to provide for ECLs prescribed by IFRS 9, which permits the use of the lifetime expected loss provision for all trade
receivables. The directors of the Company are of the opinion that the ECL in respect of the balance of trade
receivables is minimal. No loss allowance for impairment of trade receivables is provided as at 31 December 2023
and 2024 and 30 April 2025.
19. PREPAYMENTS AND OTHER RECEIV ABLES
The Group
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Non-current:
Rental and other deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,480 1,514 1,514
V alue-added tax recoverable /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,635 7,865 8,017
Others /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118160 197 199
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,275 9,576 9,730
Current:
Prepayments for research and development
services and other services /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111826,755 22,194 26,176
Rental and other deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11187,375 7,139 3,576
V alue-added tax recoverable /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,537 10,719 16,771
Other receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,469 15,420 4,816
Deferred listing expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 3,122 4,674
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111844,136 58,594 56,013
APPENDIX I ACCOUNTANTS’ REPORT
– I-47 –


--- page 655 ---
The Company
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Non-current:
Rental deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,481 1,514 1,514
Others /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118159 197 199
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,640 1,711 1,713
Current:
Prepayments for research and development
services and others /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,397 8,987 8,857
Rental and other deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118373 337 61
V alue-added tax recoverable /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,537 11,564 16,771
Other receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118319 15,071 4,754
Deferred listing expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 3,122 4,674
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11189,626 39,081 35,117
The financial assets included in the above balances relate to receivables for which there were no recent history
of default and past due amounts. In addition, there is no significant change in the economic factors based on the
assessment of the forward-looking information, so the directors of the Company are of the opinion that the ECLs in
respect of these balances are minimal. The balances are interest-free and are not secured with collateral.
20. TIME DEPOSITS AND CASH AND CASH EQUIV ALENTS
The Group
Cash and cash equivalents
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Cash at banks /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118332,197 255,226 308,644
Time deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,752 139,689 82,122
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118363,949 394,915 390,766
Less:
Time deposits over three months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(31,752) (32,790) –
Cash and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118332,197 362,125 390,766
Denominated in:
RMB /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111875,183 24,714 74,224
USD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118238,818 319,040 303,165
AUD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111818,196 18,371 13,377
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118332,197 362,125 390,766
APPENDIX I ACCOUNTANTS’ REPORT
– I-48 –


--- page 656 ---
Time deposits
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Time deposits over three months but less than
one year – current /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 32,790 –
Time deposits over one year – non-current /H1118/H1118/H1118/H1118/H111831,752 – –
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,752 32,790 –
Denominated in:
RMB /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,752 32,790 –
The Company
Cash and cash equivalents
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Cash at banks /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118241,962 217,909 282,013
Time deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,752 128,335 79,791
Subtotal /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118273,714 346,244 361,804
Less:
Time deposits over three months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(31,752) (32,790) –
Cash and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118241,962 313,454 361,804
Denominated in:
RMB /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,008 12,675 71,425
USD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118220,954 300,779 290,379
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118241,962 313,454 361,804
Time deposits
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Time deposits over three months but less than
one year – current /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 32,790 –
Time deposits over one year – non-current /H1118/H1118/H1118/H1118/H111831,752 – –
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,752 32,790 –
Denominated in:
RMB /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,752 32,790 –
USD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,752 32,790 –
The RMB is not freely convertible into other currencies, however, under Mainland China’s Foreign Exchange
Control Regulations and Administration of Settlement, Sale and Payment of Foreign Exchange Regulations, the
Group is permitted to exchange RMB for other currencies through banks authorised to conduct foreign exchange
business.
Cash at banks earns interest at floating rates based on daily bank deposit rates. The bank balances are deposited
with creditworthy banks with no recent history of default.
APPENDIX I ACCOUNTANTS’ REPORT
– I-49 –


--- page 657 ---
21. TRADE AND OTHER PAYABLES
The Group
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Current:
Trade payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,355 6,292 10,836
Payroll payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111819,656 17,711 8,561
Accrued expenses for research and development
services /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111849,335 73,704 63,964
Accrued listing expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 12,706 5,380
Other taxes payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,088 987 684
Other payables
– License-out agreement option termination fee
(note a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 68,573 69,112
– Accrued expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,910 1,216 688
– Others /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118503 544 181
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111882,847 181,733 159,406
Non-current:
Other payables
– License-out agreement option termination fee
(note a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 55,676 56,429
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 55,676 56,429
Note:
(a) The detail information of License-out option termination fee is described in Note 5.
An ageing analysis of the trade payables as at each end of the Relevant Periods, based on the invoice date, is
as follows:
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Within 3 months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,355 6,292 10,836
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,355 6,292 10,836
The trade payables are non-interest-bearing and payable on demand, which are normally settled on terms of
1 to 3 months.
APPENDIX I ACCOUNTANTS’ REPORT
– I-50 –


--- page 658 ---
The Company
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Current:
Trade payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,270 6,164 9,451
Payroll payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111811,257 11,503 5,616
Accrued expenses for research and development
services /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111836,267 66,938 58,450
Accrued listing expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 11,765 5,380
Other taxes payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118566 675 415
Other payables
– License-out agreement option termination fee
(note a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 68,573 69,112
– Accrued expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,874 706 375
– Others /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118176 535 7,204
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111860,410 166,859 156,003
Non-current:
Other payables
– License-out agreement option termination fee
(note a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 55,676 56,429
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 55,676 56,429
Note:
(a) The detail information of License-out option termination fee is described in Note 5.
An ageing analysis of the trade payables as at the end of the Relevant Periods, based on the invoice date, is
as follows:
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Within 3 months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,270 6,164 9,451
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,270 6,164 9,451
The trade payables are non-interest-bearing and payable on demand, which are normally settled on terms of
1 to 3 months.
APPENDIX I ACCOUNTANTS’ REPORT
– I-51 –


--- page 659 ---
22. INTEREST-BEARING BANK BORROWINGS
The Group and the Company
As at 31 December 2023
Effective interest
rate per annum Maturity RMB’000
%
Current:
Bank loans-unsecured /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182.85-2.95 2024 5,312
As at 31 December 2024
Effective interest
rate per annum Maturity RMB’000
%
Current:
Bank loans-unsecured /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182.50-2.90 2025 51,128
As at 30 April 2025
Effective interest
rate per annum Maturity RMB’000
%
Current:
Bank loans-unsecured /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182.50-2.75 2025-2026 85,117
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Bank loans repayable:
Within one year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,312 51,128 85,117
23. DEFERRED INCOME
The Group
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Government grants /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185 0 3––
APPENDIX I ACCOUNTANTS’ REPORT
– I-52 –


--- page 660 ---
* The movements in deferred income during the Relevant Periods are as follows:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
At beginning of the
year/period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,651 503 503 –
Grants received during the
year/period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111818,638 6,366 228 242
Amounts released to profit or
loss during the year/period /H1118 (21,786) (6,869) (678) (242)
At end of the year/period /H1118/H1118/H1118 503 – 53 –
24. CONTRACT LIABILITIES
The Group and the Company
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Contract liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118101,914 42,204 12,348
Contract liabilities represented the obligation to transfer the Ex-China Option of GFH925 to Innovent and the
obligation to transfer the Ex-China Option of GFH375 to V erastem. The changes of contractual liabilities on GFH925
are mainly due to the addition or termination of options to develop and commercialize the licensed products and
licensed compounds of GFH925 in the Ex-China Territory and the exercise of the Ex-China Option of GFH375 at the
end of the year/period as detailed in Note 5.
25. REDEMPTION LIABILITIES ON EQUITY SHARES
From January 2018 to March 2024, the Company had received several rounds of investments as follows:
In January 2018, the Company issued 2,500,000 angel round equity shares with a par value of RMB1.00 per
share (“Angel Round Shares”) to several independent investors for a cash consideration of RMB60,000,000 or
RMB24.00 per share.
In January 2019, the Company issued first tranche of 2,647,059 series A equity shares with a par value of
RMB1.00 per share (“Series A Shares”) to several independent investors for a cash consideration of RMB120,000,000
or RMB45.33 per share.
In April 2019, the Company issued 322,129 series A + equity shares with a par value of RMB1.00 per share
(“Series A+ Shares”) to one independent investors for a cash consideration of RMB20,000,000 or RMB62.09 per
share.
In February and March 2020, the Company issued second tranche of 581,622 Series A Shares to several
independent investors for a cash consideration of RMB30,000,000 or RMB51.58 per share.
In March 2020, the Company issued 5,122,199 series B equity shares with a par value of RMB1.00 per share
(“Series B Shares”) to several independent investors for a cash consideration of RMB343,000,000 or RMB66.96 per
share.
APPENDIX I ACCOUNTANTS’ REPORT
– I-53 –


--- page 661 ---
In March 2021, the Company issued 2,156,401 series B+ equity shares with a par value of RMB1.00 per share
(“Series B+ Shares”) to several independent investors for a cash consideration of RMB200,000,000 or RMB92.75 per
share.
In December 2022, the Company issued 3,889,673 series C equity shares with a par value of RMB1.00 per
share (“Series C Shares”) to several independent investors for a cash consideration of RMB491,082,000 or
RMB124.03 per share.
In March 2024, the Company issued 1,673,807 series C+ equity shares with a par value of RMB1.00 per share
(“Series C+ Shares”) to several independent investors for a cash consideration of RMB195,011,000 or RMB116.68
per share.
Angel Round Shares, Series A Shares, Series A+ Shares, Series B Shares, Series B+ Shares, Series C Shares
and Series C+ Shares are collectively referred as Shares.
The key terms of the Shares are summarized as follows:
(1) Voting rights
All shareholders, including the holders of ordinary shares and holders of Shares, are entitled to vote together
as a single class on a pro-rata basis.
(2) Dividends rights
The Group’s capital reserve, surplus reserve and undistributed reserve (if any) are shared by all shareholders
in proportion to their shareholding.
No dividend or distribution, whether in cash, in property, or in any other shares of the Group, shall be declared,
paid, set aside or made with respect to the ordinary shares at any time unless a dividend or distribution in like amount
is likewise declared, paid, set aside or made at the same time with respect to each issued and outstanding payable
of Shares in cash when, as and if declared by the Group.
(3) Redemption features
Upon occurrence of the following events which cannot be controlled by the Company, the Shares shall be
redeemable by the Company at the option of the shareholders:
(a) The Company fails to achieve a qualified IPO or qualified overall sale of the Company before 31
December 2024;
(b) the founders or controlling shareholders of the Company is changed or they have actually ceased to
contribute their time and efforts to the Company;
(c) The Company, GenFleet Therapeutics (H.K.) Limited, employee incentive platforms or the founders
seriously violates the transaction documents (including but not limited to any breach of representations,
warranties, commitments, full-time service and non-competition commitments, etc.);
(d) The founders of the Company, engage in significant acts of dishonesty that may cause unknown
off-balance liabilities or unknown off-balance cash income; or
(e) The Company or the Group undergoes events that may cause significant obstacles to the qualified IPO
of the Company and the obstacles cannot be overcome according to the relevant provisions of PRC laws
or any one of the Company, GenFleet Therapeutics (H.K.) Limited, employee incentive platforms or the
founders refuse to correct these obstacles.
The redemption amount is calculated as the higher of (i) the original investment principal from investors with
an annual compound interest rate of 12% of the original investment principal plus any dividends declared but unpaid
for a period of time commencing from the actual investment payment date to the actual settlement of redemption
amount date (referred as “P+I”) and (ii) the net assets of the Company at the time of transfer attributable to the
shareholders according to share percentage.
APPENDIX I ACCOUNTANTS’ REPORT
– I-54 –


--- page 662 ---
(4) Liquidation preferences
In the event of any liquidation or deemed liquidation event, holders of the Shares shall be entitled to be paid
out of the funds and assets available for distribution to the members of the Company, an amount per share equal to
the original issue price for each series equity share with an annual compound interest rate of 12% or 10% plus any
dividends declared but unpaid thereon in the sequence as follows:
(1) Series C+ Shares
(2) Series C Shares
(3) Series B+ Shares
(4) Series B Shares
(5) Series A+ Shares
(6) Series A Shares
(7) Angel Round Shares
(5) Anti-dilution right
If the Company increases its paid-in capital at a price lower than the price paid by the investors on a per paid-in
capital basis, the investors have a right to require the Company to issue additional paid-in capital at the lowest issue
price permitted by law to the investors or receive cash compensation from the Company, and the investors also have
a right to require the controlling shareholders to transfer shares to the investors at the lowest issue price permitted
by law or receive cash compensation from the controlling shareholders, so that the total amount paid by the investors
divided by the total amount of paid-in capital obtained is equal to the price per paid-in capital in the new issuance.
Presentation and classification
The Group and the Company have designated the Shares issued to investors as whole as financial liabilities
carried at FVTPL and presented as “redemption liabilities on equity shares” in the consolidated statements of
financial position. The change in fair value of the redemption liabilities on equity shares is charged to profit or loss
except for the portion attributable to credit risk change that shall be charged to other comprehensive income.
Management considered that the fair value change in the redemption liabilities on equity shares attributable to
changes of own credit risk is not significant.
The redemption liabilities on equity shares were presented in current liabilities as at 31 December 2023 and
2024 and 30 April 2025 as the Company would be requested to redeem the Shares upon occurrence of the events
which cannot be controlled by the Company as detailed above.
The redemption features and liquidation preferences will be automatically terminated upon Listing.
APPENDIX I ACCOUNTANTS’ REPORT
– I-55 –


--- page 663 ---
The movements in our redemption liabilities on equity shares are set out as follows:
The Group and the Company
Angel
Round
Shares
Series A
Shares
Series A+
Shares
Series B
Shares
Series B+
Shares
Series C
Shares
Series C+
Shares
Total
Shares
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At 1 January 2023 /H1118/H1118/H1118113,668 190,990 20,941 360,557 194,262 499,097 – 1,379,515
Change in fair value /H1118/H1118 13,163 39,363 5,438 98,683 50,165 50,181 – 256,993
At 31 December 2023 /H1118 126,831 230,353 26,379 459,240 244,427 549,278 – 1,636,508
Issue /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––– 195,011 195,011
Change in fair value /H1118/H1118 45,688 54,037 4,550 64,024 23,177 89,672 101,454 382,602
At 31 December 2024 /H1118 172,519 284,390 30,929 523,264 267,604 638,950 296,465 2,214,121
Issue
Change in fair value /H1118/H1118 10,268 14,426 1,337 19,639 6,498 (236) (1,240) 50,692
At 30 April 2025 /H1118/H1118/H1118/H1118182,787 298,816 32,266 542,903 274,102 638,714 295,225 2,264,813
The Company used the discounted cash flow and back-solve method to determine the underlying share value
of the Company and performed an equity allocation based on the Option Pricing model (“OPM model”) to arrive the
fair value of the redemption liabilities on equity shares as at the end of each reporting period with reference to
valuation report carried out by an independent valuer.
In addition to the underlying share value of the Company determined by the back-solve method, other key
valuation assumptions used in the OPM model to determine the fair value are as follows:
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Risk-free interest rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182.08% 1.14% 1.47%
DLOM /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815.09% 14.70% 14.10%
V olatility /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111858.00% 56.00% 58.00%
Possibilities under liquidation scenario /H1118/H1118/H1118/H1118/H1118/H1118/H111830.00% 27.50% 25.00%
Possibilities under redemption scenario /H1118/H1118/H1118/H1118/H1118/H1118/H111830.00% 27.50% 25.00%
Possibilities under conversion scenario /H1118/H1118/H1118/H1118/H1118/H1118/H111840.00% 45.00% 50.00%
The Group estimated the risk-free interest rate based on the yield of China government bond with maturity
close to the expected exit timing as of the valuation date. The DLOM was estimated based on the option-pricing
method. Under the option-pricing method, the cost of put option, which can hedge the price change before the
privately held share can be sold, was considered as a basis to determine DLOM. V olatility was estimated based on
annualized standard deviation of daily shares price return of comparable companies for a period from the valuation
date and with a similar span as time to expiration.
APPENDIX I ACCOUNTANTS’ REPORT
– I-56 –


--- page 664 ---
26. DEFERRED TAX
Deferred tax liabilities
Right-of-use assets Total
RMB’000 RMB’000
As at 1 January 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,437 4,437
Credited to the consolidated statements of profit or loss and other
comprehensive income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(929) (929)
As at 31 December 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,508 3,508
Credited to the consolidated statements of profit or loss and other
comprehensive income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,196) (1,196)
As at 31 December 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,312 2,312
Credited to the consolidated statements of profit or loss and other
comprehensive income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(173) (173)
As at 30 April 2025 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,139 2,139
Deferred tax assets
Tax Losses Lease liabilities Total
RMB’000 RMB’000 RMB’000
As at 1 January 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 4,437 4,437
(Credited)/charged to the consolidated statements of
profit or loss and other comprehensive income /H1118/H1118/H1118/H1118/H1118 10 (939) (929)
As at 31 December 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111810 3,498 3,508
Charged to the consolidated statements of profit or loss
and other comprehensive income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(10) (1,186) (1,196)
As at 31 December 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 2,312 2,312
Charged to the consolidated statements of profit or loss
and other comprehensive income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (173) (173)
As at 30 April 2025 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 2,139 2,139
For presentation purposes, certain deferred tax assets and liabilities have been offset in the statements of
financial position. The following is an analysis of the deferred tax balances of the Group for financial reporting
purposes:
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Net deferred tax assets recognised in the
consolidated statement of financial position /H1118/H1118/H1118 –––
Net deferred tax liabilities recognised in the
consolidated statement of financial position /H1118/H1118/H1118 –––
Net deferred tax liabilities in respect of
continuing operations /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––
APPENDIX I ACCOUNTANTS’ REPORT
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27. PAID-IN CAPITAL/SHARE CAPITAL
The Group and the Company
Pursuant to the shareholders’ resolutions dated 25 July 2024, the then existing shareholders of the Company
approved the conversion of the Company into a joint stock company with limited liabilities with 26,774,063 shares
in a nominal value of RMB1.0 each. Upon the completion of registration with the Administration for Market
Regulation of the Shanghai ( ɪऎ̹̹ఙ္ຖ၍ଣ҅) on 29 September 2024, the Company was converted into a joint
stock company with limited liability.
Paid-in capital/Share capital
Share capital
RMB’000
As at 1 January 2023, 31 December 2023 and 1 January 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111822,027
Issue of new shares (note a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,648
Capital contribution from employee incentive platforms (note b) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,099
As at 31 December 2024, 1 January 2025 and 30 April 2025 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111826,774
Notes:
(a) On 24 July 2023, the Company passed shareholders’ resolutions and approved the increase of the registered
capital of the Company from RMB24,852,000 to RMB25,100,000 for employee incentive platforms. On 28
December 2023, the Company passed shareholders’ resolutions and approved, among other things, the increase
of the registered capital of the Company from RMB25,100,000 to RMB26,774,000, the capital contribution by
shareholders related to the increase of the registered capital was settled in March 2024.
(b) In March 2024, the consideration of RMB12,860,000 for registered capital of RMB3,073,000 was settled by
employee incentive platforms. As at 31 December 2024, the share capital of the Company was RMB26,774,000
and fully paid.
28. RESERVES
The Group
The amounts of the Group’s share premium and other reserves and the movements therein for the Relevant
Periods are presented in the consolidated statement of changes in equity.
(a) Share premium
The share premium of the Group represents the difference between the par value of the shares issued and the
consideration received.
APPENDIX I ACCOUNTANTS’ REPORT
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(b) Share-based payment reserve
The share-based payment reserve represents the equity-settled share awards as set out in Note 29 to the
Historical Financial Information.
(c) Other reserves
Other reserves of the Group represent the carrying amounts of the equity shares with redemption features as
stipulated in Note 25 to the Historical Financial Information.
(d) Foreign currency translation reserve
The foreign currency translation reserve is used to record exchange differences arising from the translation of
the financial statements of entities of which the functional currency is not RMB.
The Company
Share premium
Share-based
payment
reserve Other reserves
Accumulated
losses Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At 1 January 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,246,080 1,555 (1,264,082) (621,076) (637,523)
Loss for the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – – (396,208) (396,208)
Total comprehensive loss for the
year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – – (396,208) (396,208)
Share-based payment
compensation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 36,968 – – 36,968
At 31 December 2023 and
1 January 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,246,080 38,523 (1,264,082) (1,017,284) (996,763)
Loss for the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – – (582,669) (582,669)
Total comprehensive loss for the
year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – – (582,669) (582,669)
Issue of new shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118193,33 8––– 193,338
Capital contribution from
employee incentive platforms /H1118 9,78 6––– 9,786
Capitalisation Issue (note a) /H1118/H1118/H1118/H1118(734,351) – – 734,351 –
Recognition of redemption
liabilities on equity shares /H1118/H1118/H1118 – – (195,011) – (195,011)
Share-based payment
compensation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 26,942 – – 26,942
At 31 December 2024 and
1 January 2025 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118714,853 65,465 (1,459,093) (865,602) (1,544,377)
Loss for the period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – – (42,797) (42,797)
Total comprehensive loss for the
period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – – (42,797) (42,797)
Share-based payment
compensation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 8,776 – – 8,776
At 30 April 2025 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118714,853 74,241 (1,459,093) (908,399) (1,578,398)
Note:
(a) On 29 September 2024, the Company was converted into a joint stock company with limited liability under
the Company Law of the PRC. The net assets of the Company under PRC Generally Accepted Accounting
Principles as of the conversion base date, including paid-in capital, share premium and accumulated losses,
amounting to RMB760,278,237 were converted into 26,774,063 share capital at RMB1.00 each.
APPENDIX I ACCOUNTANTS’ REPORT
– I-59 –


--- page 667 ---
29. SHARE-BASED PAYMENTS
Employee Incentive Scheme
The Company adopted a share incentive plan (“Employee Incentive Scheme”) in 2020, as amended and
restated in 2023, for the purpose of attracting and retaining the best talents who promote the success of the Group’s
operations. Eligible participants of the Employee Incentive Scheme include the certain directors of the Company, and
employees of the Group. Pursuant to the adopted Employee Incentive Scheme in 2023, 2,383,606 shares of the
Company were allocated to four employee incentive platforms. The restricted shares granted to each grantee shall
vest and tradeable upon one year anniversary of the listing date of the Company. The eligible participants would be
repaid with original subscription price plus single digit interest if employment were terminated before the vesting
date. After taking into consideration of the best estimation of the listing date, the management determined the vesting
period of the relevant restricted shares based on the above performance conditions and service requirements. As such,
the share-based payment expenses are amortised during the vesting period.
The fair value of services received in return for shares granted to employees and directors was measured by
reference to the fair value of the shares granted and the subscription price paid by employees and directors. During
the Relevant Periods, the Company granted nil, 2,226,857 and 42,000 restricted shares, respectively, with fair values
ranging from RMB24.67 to RMB60.83 per share.
Details of the granted shares are as follows:
Date of grant
Number of
restricted shares
Subscription price
per share
Fair value
of the underlying
shares
2020/12/21 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118246,000 RMB0.0000 RMB24.67
2023/10/31 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,098,607 RMB5.6658 RMB53.65
2023/10/31 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118128,250 RMB0.0000 RMB53.65
2023/9/30 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,000,000 RMB5.7562 RMB53.65
2024/2/29 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,000 RMB5.6658 RMB53.65
2024/4/30 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111810,000 RMB5.6658 RMB60.83
2024/5/31 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816,000 RMB5.6658 RMB60.83
2024/6/7 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,000 RMB0.0000 RMB60.83
2024/6/7 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,000 RMB5.6658 RMB60.83
2024/7/12 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,000 RMB5.6658 RMB60.83
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,522,857
The following numbers of restricted shares were outstanding under the Employee Incentive Scheme during the
Relevant Periods:
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
At the beginning of the year/period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118171,000 2,383,607 2,383,607
Granted during the year/period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,226,857 50,000 –
Forfeited during the year/period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(14,250) (50,000) –
At the end of the year/period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,383,607 2,383,607 2,383,607
During the Relevant Periods and the four months ended 30 April 2024, share-based payment compensation
expenses of RMB36,968,000, RMB26,942,000, RMB8,776,000 and RMB9,584,000 (unaudited) were charged to
profit or loss.
The fair values of the restricted shares as at the grant date were determined with reference to the fair value
of ordinary shares on the grant dates, using back-solve method. Major inputs used for the determination of the fair
values of ordinary shares are listed as follows:
At grant dates
Expected volatility /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111854%-58%
Risk-free interest rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182.08%-2.86%
Discount for lack of marketability /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815.09%-22.24%
APPENDIX I ACCOUNTANTS’ REPORT
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--- page 668 ---
30. INVESTMENTS IN SUBSIDIARIES
The Company
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Investment Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118303,526 398,352 411,740
31. NOTES TO THE CONSOLIDATED STATEMENTS OF CASH FLOWS
(a) Major non-cash transactions
During the Relevant Periods, the Group had non-cash additions to right-of-use assets of nil and nil and
non-cash additions to lease liabilities of nil and nil, respectively, in respect of lease arrangements for office premises.
(b) Changes in liabilities arising from financing activities
Lease liabilities
Interest-bearing
bank
borrowings
Redemption
liabilities on
equity shares
Accrued
transaction cost
on issue of
redemption
liabilities on
equity shares in
trade and other
payables
Accrued listing
expenses
included in
trade and other
payable
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At 1 January 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,763 22,767 1,379,515 4,717 –
Changes from financing
cash flows
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 5,31 2–––
Payments /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(6,768) (22,886) – (4,717) –
Accretion of interest recognised
during the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,366 11 9–––
Change in fair value of
redemption liabilities on
equity shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 256,993 – –
At 31 December 2023 and
1 January 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111826,361 5,312 1,636,508 – –
Changes from financing
cash flows
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 56,928 195,011 11,840 3,122
Payments /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(6,256) (11,989) – (11,840) (1,276)
Accretion of interest recognised
during the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 , 1 1 2 8 7 7–––
Change in fair value of
redemption liabilities on
equity shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 382,602 – –
Lease reassessment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(2,997) ––––
At 31 December 2024 and
1 January 2025 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111818,220 51,128 2,214,121 – 1,846
Changes from financing cash
flows /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118173 54,900 – – 1,552
Payments /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(2,458) (21,529) – – (2,731)
Accretion of interest recognised
during the period /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182 7 1 6 1 8–––
Change in fair value of
redemption liabilities on
equity shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 50,692 – –
At 30 April 2025 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816,206 85,117 2,264,813 – 667
APPENDIX I ACCOUNTANTS’ REPORT
– I-61 –


--- page 669 ---
(c) Total cash outflow for leases
The total cash outflow for leases included in the consolidated statements of cash flows is as follows:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Within operating activities /H1118/H1118/H1118/H1118/H1118/H1118/H11181,540 961 375 387
Within financing activities /H1118/H1118/H1118/H1118/H1118/H1118/H11186,768 6,256 2,016 2,458
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,308 7,217 2,391 2,845
32. COMMITMENTS
The Group had the following contractual commitments at the end of the Relevant Periods:
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Property, plant and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111851–
33. RELATED PARTY TRANSACTIONS
(a) Names and relationships
Name of related parties Relationship with the Group
Hongyong Binde (Hong Kong) Limited (ᅃ(ಥ)ʮ̡)
(“Hongyong”) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Shareholder of the Company*
* Hongyong has significant influence over the Group as Hongyong had a representation on the board of
directors of the Company.
(b) Significant related party transactions
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Rendering of services
Hongyong /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 1,191 1,191 –
APPENDIX I ACCOUNTANTS’ REPORT
– I-62 –


--- page 670 ---
(c) Compensation of key management personnel of the Group:
Y ear ended 31 December Four months ended 30 April
2023 2024 2024 2025
RMB’000 RMB’000 RMB’000 RMB’000
(unaudited)
Salaries, allowances and
benefits in kind /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,757 1,996 322 994
Performance related bonuses /H1118/H1118/H1118/H1118/H11182,888 3,328 1,109 842
Pension scheme contributions /H1118/H1118/H1118/H1118/H1118 ––––
Equity-settled share award expense /H1118 31,09 0–––
Total compensation paid to key
management personnel /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111836,735 5,324 1,431 1,836
Further details of directors’ and supervisors’ emoluments are included in Note 10 to the Historical Financial
Information.
34. FINANCIAL INSTRUMENTS BY CATEGORY
The carrying amounts of each of the categories of financial instruments as at the end of the Relevant Periods
are as follows:
The Group
Financial assets
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Financial assets at amortised cost:
Trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,353 109,153 97,518
Financial assets included in prepayments and
other receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814,324 24,073 9,906
Cash and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118332,197 362,125 390,766
Time deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111831,752 32,790 –
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118450,626 528,141 498,190
Financial liabilities
As at
31 December
As at
31 December
As at
30 April
2023 2024 2025
RMB’000 RMB’000 RMB’000
Financial liabilities at FVTPL:
Redemption liabilities on equity shares /H1118/H1118/H1118/H1118/H1118/H1118/H11181,636,508 2,214,121 2,264,813
Financial liabilities at amortised cost:
Interest-bearing bank borrowings /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,312 51,128 85,117
Financial liabilities included in trade and
other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111862,103 218,711 206,590
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111867,415 269,839 291,707
APPENDIX I ACCOUNTANTS’ REPORT
– I-63 –


--- page 671 ---
35. FAIR V ALUE AND FAIR V ALUE HIERARCHY OF FINANCIAL INSTRUMENTS
Fair values
Management has assessed that the fair values of cash and cash equivalents, financial assets included in
prepayments and other receivables (in the current portion), financial liabilities included in trade and other payables
approximate to their carrying amounts largely due to the short-term maturities of these instruments. The fair values
of the other non-current financial assets and financial liabilities have been calculated by discounting the expected
future cash flows using rates currently available for instruments with similar terms, credit risk and remaining
maturities.
The Group’s finance department headed by the finance manager is responsible for determining the policies and
procedures for the fair value measurement of financial instruments. At the end of the Relevant Periods, the finance
department analyses the movements in the values of financial instruments and determines the major inputs applied
in the valuation. The valuation is reviewed and approved by the finance manager.
The fair values of the financial assets and liabilities are included at the amount at which the instrument could
be exchanged in a current transaction between willing parties, other than in a forced or liquidation sale.
The Group invests in financial assets at fair value through profit or loss, which represent structured deposits
products issued by banks. The fair values are based on cash flows discounted using the expected yield rate.
The fair values of the redemption liabilities on equity shares measured at FVTPL are determined using the
OPM. Further details are set out in note 25 to the Historical Financial Information.
Fair value hierarchy
The following tables illustrate the fair value measurement hierarchy of the Group’s financial instruments:
The Group
Liabilities measured at fair value:
Fair value measurement using
Quoted prices in
active markets
Significant
observable inputs
Significant
unobservable
inputs
Total(Level 1) (Level 2) (Level 3)
RMB’000 RMB’000 RMB’000 RMB’000
As at 31 December 2023
Redemption liabilities on equity
shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 1,636,508 1,636,508
As at 31 December 2024
Redemption liabilities on equity
shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 2,214,121 2,214,121
As at 30 April 2025
Redemption liabilities on equity
shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 2,264,813 2,264,813
During the Relevant Periods, there were no transfers of fair value measurements between Level 1 and Level
2 and no transfers into or out of Level 3 for both financial assets and financial liabilities.
APPENDIX I ACCOUNTANTS’ REPORT
– I-64 –


--- page 672 ---
Below is a summary of significant unobservable inputs to the valuation of financial instruments together with
a quantitative sensitivity analysis as at the end of each of the Relevant Periods:
As at 31 December 2023:
Valuation technique
Significant
unobservable inputs Range Sensitivity of fair value to the input
Redemption
liabilities on
equity shares /H1118/H1118
Back-solve method Risk-free interest
rate
2.08% 1% increase/decrease in
risk-free interest rate would
result in decrease/increase
fair value by
RMB(962,000)/
RMB3,091,000
V olatility 58.00% 1% increase/decrease in
volatility would result in
decrease/increase fair value
by RMB(622,000)/
RMB611,000
DLOM 15.09% 1% increase/decrease in
DLOM would result in
decrease/increase in fair
value by RMB(18,917,000)/
RMB18,917,000
As at 31 December 2024:
Valuation technique
Significant
unobservable inputs Range Sensitivity of fair value to the input
Redemption
liabilities on
equity shares /H1118/H1118
Back-solve method Risk-free interest
rate
1.14% 1% increase/decrease in risk-
free interest rate would
result in decrease/increase
fair value by
RMB(3,574,000)/
RMB5,732,000
V olatility 56.00% 1% increase/decrease in
volatility would result in
decrease/increase fair value
by RMB(1,034,000)/
RMB1,023,000
DLOM 14.60% 1% increase/decrease in
DLOM would result in
decrease/increase in fair
value by RMB(25,523,000)/
RMB25,523,000
APPENDIX I ACCOUNTANTS’ REPORT
– I-65 –


--- page 673 ---
As at 30 April 2025:
Valuation technique
Significant
unobservable inputs Range Sensitivity of fair value to the input
Redemption
liabilities on
equity shares /H1118/H1118
Back-solve method Risk-free interest
rate
1.47% 1% increase/decrease in
risk-free interest rate would
result in decrease/increase
fair value by
RMB(1,962,000)/
RMB2,647,000
V olatility 58.00% 1% increase/decrease in
volatility would result in
decrease/increase fair value
by RMB(807,000)/
RMB795,000
DLOM 14.10% 1% increase/decrease in
DLOM would result in
decrease/increase in fair
value by RMB(26,121,000)/
RMB26,121,000
36. FINANCIAL RISK MANAGEMENT OBJECTIVES AND POLICIES
Foreign currency risk
The Group has transactional currency exposures. Such exposures arise from financing activities by subsidiaries
in currencies other than the subsidiaries’ functional currencies.
The following table demonstrates the sensitivity at the end of each of the Relevant Periods to a reasonably
possible change in the USD and AUD exchange rates, with all other variables held constant, of the Group’s loss
before tax and equity (due to changes in the fair value of monetary assets and liabilities).
Increase/(decrease)
in rate of foreign
currency
Increase/(decrease)
in loss before tax
Increase/(decrease)
in equity
% RMB’000 RMB’000
31 December 2023
If RMB weakens against USD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185 (1,001) 1,001
If RMB strengthens against USD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5) 1,001 (1,001)
If RMB weakens against AUD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185 (910) 910
If RMB strengthens against AUD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5) 910 (910)
31 December 2024
If RMB weakens against USD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185 (194) 194
If RMB strengthens against USD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5) 194 (194)
If RMB weakens against AUD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185 (919) 919
If RMB strengthens against AUD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5) 919 (919)
30 April 2025
If RMB weakens against USD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185 (1,815) 1,815
If RMB strengthens against USD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5) 1,815 (1,815)
If RMB weakens against AUD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185 (553) 553
If RMB strengthens against AUD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5) 553 (553)
APPENDIX I ACCOUNTANTS’ REPORT
– I-66 –


--- page 674 ---
Credit risk
The Group trades only with recognised and creditworthy third parties. It is the Group’s policy that all
customers who wish to trade on credit terms are subject to credit verification procedures. In addition, receivable
balances are monitored on an ongoing basis and the Group’s exposure to bad debts is not significant. For transactions
that are not denominated in the functional currency of the relevant operating unit, the Group does not offer credit
terms without the specific approval of the head of credit control.
The Group’s credit risk is primarily attributable to trade receivables. The Group has applied the simplified
approach to provide for ECLs prescribed by IFRS 9, which permits the use of the lifetime expected loss provision
for all trade receivables. The directors of the Company are of the opinion that the ECL in respect of the balance of
trade receivables is minimal. No loss allowance for impairment of trade receivables is provided as at 30 April 2025.
For other receivables and other non-current assets, management has assessed that during the years ended
31 December 2023 and 2024, and the four months ended 30 April 2025, other receivables and other non-current assets
have not had a significant increase in credit risk since initial recognition. Thus, a 12-month expected credit loss
approach that results from possible default event within 12 months of each reporting date is adopted by management.
The Group does not expect any losses from non-performance by the counterparties of other receivables and no loss
allowance provision for other receivables and other non-current assets was recognized.
To measure the expected credit losses, other receivables have been grouped based on shared credit risk
characteristics and the days past due. As at 31 December 2023 and 2024 and 30 April 2025, the Group has assessed
that the expected loss rate for other receivables was immaterial. Thus no loss allowance provision for other
receivables was recognized as at 31 December 2023 and 2024 and 30 April 2025.
Liquidity risk
The Group monitors and maintains a level of cash and cash equivalents deemed adequate by the management
of the Group to finance the operations and mitigate the effects of fluctuations in cash flows.
The maturity profile of the Group’s financial liabilities as at the end of the Relevant Periods, based on the
contractual undiscounted payments, is as follows:
The Group
As at 31 December 2023
Within 1 year 1 to 5 years Over 5 years Total
RMB’000 RMB’000 RMB’000 RMB’000
Financial liabilities included in trade
and other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111862,103 – – 62,103
Interest-bearing bank borrowings /H1118/H1118/H1118 5,399 – – 5,399
Redemption liabilities on equity
shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,715,411 – – 1,715,411
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,981 24,681 – 30,662
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,788,894 24,681 – 1,813,575
APPENDIX I ACCOUNTANTS’ REPORT
– I-67 –


--- page 675 ---
As at 31 December 2024
Within 1 year 1 to 5 years Over 5 years Total
RMB’000 RMB’000 RMB’000 RMB’000
Financial liabilities included in trade
and other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118166,306 57,507 – 223,813
Interest-bearing bank borrowings /H1118/H1118/H1118 51,637 – – 51,637
Redemption liabilities on equity
shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,082,681 – – 2,082,681
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,014 15,015 – 20,029
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,305,638 72,522 – 2,378,160
As at 30 April 2025
Within 1 year 1 to 5 years Over 5 years Total
RMB’000 RMB’000 RMB’000 RMB’000
Financial liabilities included in trade
and other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118153,063 57,611 – 210,674
Interest-bearing bank borrowings /H1118/H1118/H1118 86,405 – – 86,405
Redemption liabilities on equity
shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,140,215 – – 2,140,215
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,288 13,688 – 18,976
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,384,971 71,299 – 2,456,270
Capital management
The primary objectives of the Group’s capital management are to safeguard the Group’s ability to continue as
a going concern and to maintain healthy capital ratios in order to support its business and maximise shareholders’
value.
The Group manages its capital structure and makes adjustments to it in light of changes in economic conditions
and the risk characteristics of the underlying assets. To maintain or adjust the capital structure, the Group may adjust
the dividend payment to shareholders, return capital to shareholders or issue new shares. The Group is not subject
to any externally imposed capital requirements. No changes were made in the objectives, policies or processes for
managing capital during the Relevant Periods.
37. EVENT AFTER THE RELEV ANT PERIOD
No significant events of the Group occurred after 30 April 2025.
38. SUBSEQUENT FINANCIAL STATEMENTS
No audited financial statements have been prepared by the Company, the Group or any of the companies now
comprising the Group in respect of any period subsequent to 30 April 2025.
APPENDIX I ACCOUNTANTS’ REPORT
– I-68 –


--- page 676 ---
The following information does not form part of the Accountants’ Report from Ernst &
Young, Certified Public Accountants, Hong Kong, the Company’ s reporting accountants, as set
out in Appendix I to this Document, and is included herein for information purpose only. The
unaudited pro forma financial information should be read in conjunction with the section
headed “Financial Information” in this Document and the Accountants’ Report set out in
Appendix I to this Document.
A. UNAUDITED PRO FORMA STATEMENT OF ADJUSTED CONSOLIDATED NET
TANGIBLE ASSETS
The following unaudited pro forma adjusted consolidated net tangible assets of the Group
prepared in accordance with Rule 4.29 of the Rules Governing the Listing of Securities on the
Stock Exchange of Hong Kong Limited and with reference to Accounting Guideline 7
Preparation of Pro Forma Financial Information for inclusion in Investment Circulars issued
by the Hong Kong Institute of Certified Public Accountants for illustration purposes only, and
is set out here to illustrate the effect of the Global Offering on the consolidated net tangible
assets of the Group attributable to owners of the parent as if the Global Offering had taken
place on April 30, 2025.
The unaudited pro forma statement of adjusted consolidated net tangible assets of the
Group has been prepared for illustrative purpose only and, because of its hypothetical nature,
it may not give a true picture of the consolidated net tangible assets of the Group to owners
of the parent had the Global Offering been completed as of April 30, 2025 or as at any future
dates.
Consolidated net
tangible liabilities
of the Group
attributable to
owners of the
parent as at
April 30, 2025
Estimated
net Proceeds
from the
Global
Offering
Estimated
impact to the
consolidated
net tangible
liabilities
upon the
derecognition
of redemption
liabilities on
equity shares
upon Listing
Unaudited
pro forma
adjusted
consolidated
net tangible
assets
attributable
to owners of
the parent
as at
April 30, 2025
Unaudited
pro forma adjusted
consolidated net
tangible assets per
Share attributable to
owners of the
parent as at
April 30, 2025
RMB’000 RMB’000 RMB’000 RMB’000 RMB HK$
(Note 1) (Note 2) (Note 3) (Note 4&5) (Note 6)
Based on an Offer
Price of HK$20.39
per Share /H1118/H1118/H1118/H1118/H1118/H1118/H1118(2,014,837) 1,343,833 2,264,813 1,593,809 4.62 5.06
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-1 –


--- page 677 ---
Notes:
1. The consolidated net tangible liabilities of the Group attributable to equity holders of the Company as at April
30, 2025 is arrived at after deducting intangible assets or RMB1,198,000 from the audited net liabilities
attributable to owners of the parent as at April 30, 2025 of RMB2,013,639,000 set out in the Accountants’
Report in Appendix I to this Prospectus.
2. The estimated net proceeds from the Global Offering are based on the offer price of HK$20.39 per Share after
deduction of the underwriting fees and other related expenses payable by the Company (excluding the listing
expenses that have been charged to profit or loss during the Track Record Period) and do not take into account
any share which may be sold and offered upon exercise of the Offer Size Adjustment Option, the
Over-allotment Option.
3. Upon the Listing and the completion of the Global Offering, all redemption liabilities on equity shares will be
automatically derecognized. The redemption liabilities on equity shares will then be transferred from liabilities
to equity. Accordingly, for the purpose of the unaudited pro forma financial information, the unaudited pro
forma adjusted net tangible assets attributable to owners of the parent will be increased by RMB2,264,813,000,
being the carrying amounts of the redemption liabilities on equity shares as at April 30, 2025.
4. The unaudited pro forma adjusted consolidated net tangible assets per Share is arrived at after adjustments
referred to in the preceding note 2 and 3 and on the basis that 345,340,630 Shares were in issue assuming the
Subdivision and the Global Offering has been completed on April 30, 2025.
5. For the purpose of this unaudited pro forma statement of adjusted net tangible assets, the balances stated in
RMB are converted into HK$ at the rate of RMB1.00 to HK$1.0967.
6. No other adjustment has been made to the unaudited pro forma adjusted consolidated net tangible assets to
reflect any trading results or other transactions of the Group entered into subsequent to April 30, 2025.
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-2 –


--- page 678 ---
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Ernst & Young
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B. INDEPENDENT REPORTING ACCOUNTANTS’ ASSURANCE REPORT ON THE
COMPILATION OF PRO FORMA FINANCIAL INFORMATION
To the Directors of GenFleet Therapeutics (Shanghai) Inc.
We have completed our assurance engagement to report on the compilation of pro forma
financial information of GenFleet Therapeutics (Shanghai) Inc. (the “Company”) and its
subsidiaries (hereinafter collectively referred to as the “Group”) by the directors of the
Company (the “Directors”) for illustrative purposes only. The pro forma financial information
consists of the pro forma consolidated net tangible assets as at April 30, 2025, and related notes
as set out on pages II-1 to II-2 of the prospectus dated 11 September 2025 issued by the
Company (the “Pro Forma Financial Information”). The applicable criteria on the basis of
which the Directors have compiled the Pro Forma Financial Information are described in Part
A of Appendix II to the Prospectus.
The Pro Forma Financial Information has been compiled by the Directors to illustrate the
impact of the global offering of shares of the Company on the Group’s financial position as at
April 30, 2025 as if the transaction had taken place at April 30, 2025. As part of this process,
information about the Group’s financial position has been extracted by the Directors from the
Group’s financial statements for the year ended April 30, 2025, on which an accountants’ report
has been published.
Directors’ responsibility for the Pro Forma Financial Information
The Directors are responsible for compiling the Pro Forma Financial Information in
accordance with Rule 4.29 of the Rules Governing the Listing of Securities on The Stock
Exchange of Hong Kong Limited (the “Listing Rules”) and with reference to Accounting
Guideline (“AG”) 7 Preparation of Pro Forma Financial Information for Inclusion in
Investment Circulars issued by the Hong Kong Institute of Certified Public Accountants (the
“HKICPA”).
Our independence and quality management
We have complied with the independence and other ethical requirements of the Code of
Ethics for Professional Accountants issued by the HKICPA, which is founded on fundamental
principles of integrity, objectivity, professional competence and due care, confidentiality and
professional behavior.
Our firm applies Hong Kong Standard on Quality Management 1 Quality Management for
Firms that Perform Audits or Reviews of Financial Statements, or Other Assurance or Related
Services Engagements which requires the firm to design, implement and operate a system of
quality management including policies or procedures regarding compliance with ethical
requirements, professional standards and applicable legal and regulatory requirements.
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-3 –


--- page 679 ---
Reporting accountants’ responsibilities
Our responsibility is to express an opinion, as required by paragraph 4.29(7) of the
Listing Rules, on the Pro Forma Financial Information and to report our opinion to you. We do
not accept any responsibility for any reports previously given by us on any financial
information used in the compilation of the Pro Forma Financial Information beyond that owed
to those to whom those reports were addressed by us at the dates of their issue.
We conducted our engagement in accordance with Hong Kong Standard on Assurance
Engagements 3420 Assurance Engagements to Report on the Compilation of Pro Forma
Financial Information Included in a Prospectus issued by the HKICPA. This standard requires
that the reporting accountants plan and perform procedures to obtain reasonable assurance
about whether the Directors have compiled the Pro Forma Financial Information in accordance
with Rule 4.29 of the Listing Rules and with reference to AG 7 issued by the HKICPA.
For purposes of this engagement, we are not responsible for updating or reissuing any
reports or opinions on any historical financial information used in compiling the Pro Forma
Financial Information, nor have we, in the course of this engagement, performed an audit or
review of the financial information used in compiling the Pro Forma Financial Information.
The purpose of the Pro Forma Financial Information included in the Prospectus is solely
to illustrate the impact of the global offering of shares of the Company on unadjusted financial
information of the Group as if the transaction had been undertaken at an earlier date selected
for purposes of the illustration. Accordingly, we do not provide any assurance that the actual
outcome of the transaction would have been as presented.
A reasonable assurance engagement to report on whether the Pro Forma Financial
Information has been properly compiled on the basis of the applicable criteria involves
performing procedures to assess whether the applicable criteria used by the Directors in the
compilation of the Pro Forma Financial Information provide a reasonable basis for presenting
the significant effects directly attributable to the transaction, and to obtain sufficient
appropriate evidence about whether:
 the related pro forma adjustments give appropriate effect to those criteria; and
 the Pro Forma Financial Information reflects the proper application of those
adjustments to the unadjusted financial information.
The procedures selected depend on the reporting accountants’ judgment, having regard to
the reporting accountants’ understanding of the nature of the Group, the transaction in respect
of which the Pro Forma Financial Information has been compiled, and other relevant
engagement circumstances.
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-4 –


--- page 680 ---
The engagement also involves evaluating the overall presentation of the Pro Forma
Financial Information.
We believe that the evidence we have obtained is sufficient and appropriate to provide a
basis for our opinion.
Opinion
In our opinion:
(a) the Pro Forma Financial Information has been properly compiled on the basis stated;
(b) such basis is consistent with the accounting policies of the Group; and
(c) the adjustments are appropriate for the purpose of the Pro Forma Financial
Information as disclosed pursuant to paragraph 4.29(1) of the Listing Rules.
Ernst & Y oung
Certified Public Accountants
Hong Kong
11 September 2025
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-5 –


--- page 681 ---
The Articles of Association is considered and approved at the general meeting of the
Company, which shall come into effective and be implemented upon the initial public offering
of the overseas-listed foreign shares of the Company and from the date of its listing and trading
on the Hong Kong Stock Exchange.
GENERAL PROVISIONS
The Company is a joint stock company with perpetual existence.
All assets of the Company shall be divided into shares of equal value. The shareholders
shall be liable to the Company to the extent of the shares they subscribed for. The Company
shall be liable for its debts to the extent of all of its assets.
From the effective date of the Articles of Association, the Articles of Association shall be
a legally binding document which regulates the Company’s organization and acts, governs the
rights and obligations between the Company and the shareholders, and amongst the
shareholders themselves, and shall be a legally binding document governing on the Company,
its shareholders, directors, supervisors, and senior management. Pursuant to the Articles of
Association, a shareholder may take legal actions against the other shareholders; a shareholder
may take legal actions against the Company’s directors, supervisors and senior management;
a shareholder may take legal actions against the Company; and the Company may take legal
actions against its shareholders, directors, supervisors and senior management.
SHARES
Issuance of Shares
The shares of the Company shall take the form of share certificates.
The shares of the Company shall be issued in accordance with the principles of openness,
fairness and impartiality. Each share of the same class shall carry the same rights.
Shares of the same class and in the same issuance shall be issued on the same conditions
and at the same price. Any entity or individual shall pay the same price for each of the shares
he/she subscribes for.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-1 –


--- page 682 ---
INCREASE, REDUCTION AND REPURCHASE OF SHARES
Capital Increase
The Company may, based on its operational and developmental needs, increase its capital
in accordance with applicable laws, administrative regulations, departmental rules, normative
documents, the securities regulatory rules of the place where the Company’s shares are listed
and the requirements of relevant regulatory authorities, and subject to a resolution of the
general meeting, by any of the following methods:
(I) a public offering of shares;
(II) a non-public offering of shares;
(III) allotment bonus shares to existing shareholders;
(IV) conversion of common reserve funds to share capital;
(V) other methods permitted by the laws, administrative regulations as well as the CSRC
and the securities regulatory authorities of the place where the Company’s shares are
listed.
Capital Reduction
The Company may reduce its registered capital. If the Company reduces its registered
capital, it shall do so by the procedures set forth in the Company Law, the securities regulatory
rules of the place where the Company’s shares are listed, other relevant regulations and the
Articles of Association.
Repurchase of Shares
The Company shall not acquire its shares, except under one of the following
circumstances:
(I) reducing the registered capital of the Company;
(II) merging with other companies that hold shares in the Company;
(III) using the shares for employee shareholding schemes or as share incentives;
(IV) acquiring the shares of shareholders (upon their request) who vote against any
resolution adopted at any general meetings on the merger or division of the
Company;
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-2 –


--- page 683 ---
(V) using the shares to satisfy the conversion of those corporate bonds convertible into
share certificates issued by the Company;
(VI) safeguarding corporate value and shareholders’ equity as the Company deems
necessary;
(VII) other circumstances as stipulated by the laws, administrative regulations,
departmental rules, and the securities regulatory rules of the place where the
Company’s shares are listed (including but not limited to the Hong Kong Listing
Rules).
The Company may acquire its own shares through public and centralized trading or other
ways specified by the laws, administrative regulations, the CSRC and the securities regulatory
authorities of the place where the Company’s shares are listed, and in accordance with
applicable laws, administrative regulations and departmental rules.
In the event that the Company acquires its own shares under the circumstances set forth
in (I) and (II) above, this shall be resolved at a general meeting of shareholders; in the event
that the Company acquires its own shares under the circumstances set forth in (III), (V) and
(VI) above, this shall be resolved at a board meeting with more than two-thirds of directors
present.
After the Company acquires its own shares, under the circumstance in (I) above, the
shares so acquired shall be cancelled within 10 days from the date of acquisition. In the case
of (II) or (IV) above, the shares so acquired shall be transferred or cancelled within 6 months.
In the event that the Company acquires its own shares under the circumstances set forth
in (III), (V) or (VI) above, the shares so acquired shall not exceed 10% of the total issued
shares of the Company, and they shall be transferred or cancelled within 3 years.
If the relevant laws and regulations, normative documents and the securities regulatory
rules of the place where the Company’s shares are listed (including but not limited to the Hong
Kong Listing Rules) otherwise have provisions in respect of matters related to the aforesaid
repurchase of share, without prejudicing the Company Law and the Securities Law, such
provisions shall prevail.
Transfer of Shares
The shares of the Company may be transferred in accordance with the laws.
The Company shall not accept any of its own shares as the subject of pledges.
Shares issued prior to the Company’s public offering of shares shall not be transferred for
a period of 1 year from the date of listing and trading of the Company’s shares on the stock
exchange.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-3 –


--- page 684 ---
The directors, supervisors and senior management of the Company shall declare to the
Company the numbers of the shares of the Company held by them and the changes thereof and
shall not transfer in a given year during their terms of office determined at the time of their
assumption of office more than 25% of the total number of shares of the Company they hold.
The shares of the Company held by the said person shall not be transferred within 1 year from
the date of listing and trading of the Company’s shares. Any of the aforesaid persons shall not
transfer the shares of the Company held by him/her within 6 months from his/her termination
of the office.
If the relevant provisions of the securities regulatory authorities of the place where the
Company’s shares are listed have any other provisions in respect of restrictions on transfer of
overseas-listed shares, such provisions shall prevail.
SHAREHOLDERS AND GENERAL MEETINGS
Shareholders
The Company shall establish a register of shareholders based on the requirements as
stipulated by the Company Law, the securities regulatory rules of the place where the
Company’s shares are listed, other relevant regulations and the Articles of Association. The
register of shareholders shall be the sufficient evidence of the shareholders’ shareholding in the
Company.
A shareholder is entitled to rights and assumes obligations as per the class of the shares
held by them. Shareholders holding the same class of shares shall be entitled to the same rights
and assume the same obligations.
When the Company convenes the general meeting, distributes dividends, goes into
liquidation or is involved in other actions that require the confirmation of the shareholders’
identities, the Board or the convener of the general meeting shall determine a record date of
shareholdings, and the shareholders whose names are registered on the register of shareholders
at closing on the record date of shareholdings shall be the shareholders entitled to the relevant
interests.
Rights and Obligations of Shareholders
The shareholders of the Company shall be entitled to the following rights:
(I) to receive distribution of dividends and other forms of benefits in proportion
according to the number of shares held;
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-4 –


--- page 685 ---
(II) to legally require, convene, preside over, participate in or appoint a shareholder
proxy to participate in the general meeting and exercise corresponding right to speak
and voting right (except for situations where voting rights are required to be waived
on relevant matters in accordance with the securities regulatory rules of the place
where the Company’s shares are listed);
(III) to supervise the business operations of the Company, put forward proposals or raise
enquiries;
(IV) to transfer, give as gift or pledge the shares held in accordance with the laws,
administrative regulations, the securities regulatory rules of the place where the
Company’s shares are listed, other relevant regulations and the Articles of
Association;
(V) to inspect the Articles of Association, register of shareholders, corporate bond stubs,
minutes of general meetings, resolutions of the Board meetings, resolutions of
meetings of the supervisory committee and financial accounting reports;
(VI) in the event of the termination or liquidation of the Company, to participate in the
distribution of the remaining assets of the Company in proportion to the number of
shares held;
(VII) with respect to shareholders who voted against any resolution adopted at any general
meetings on the merger or division of the Company, to request the Company to buy
back the shares held by them;
(VIII) other rights as stipulated by the laws, administrative regulations, departmental rules,
the securities regulatory rules of the place where the Company’s shares are listed
(including but not limited to the Hong Kong Listing Rules) or the Articles of
Association.
Where the content of a resolution of the general meeting or the meeting of the Board of
the Company violates laws or administrative regulations, the shareholders shall be entitled to
request the People’s Court to hold it invalid.
If the convening procedure or voting method of a general meeting or board meeting
violates laws, administrative regulations or the Articles of Association, or if the content of a
resolution violates the Articles of Association, the shareholders shall be entitled to request the
People’s Court to revoke the resolution within 60 days from the date it was made, except for
those with only minor defects in the convening procedure or voting method of the Board
meetings and those without material impact on resolutions.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-5 –


--- page 686 ---
Shareholders who have not been notified to attend the general meeting may apply to the
People’s Court for revocation within sixty days from the date they knew or should have known
of the passing of the resolution of the general meeting; if the right to revoke is not exercised
within one year from the date the resolution is made, the right to revoke shall be extinguished.
In the event of any loss caused to the Company as a result of violation of any laws,
administrative regulations or the Articles of Association by the directors or senior management
when performing their duties in the Company, the shareholders holding 1% or more shares of
the Company separately or jointly for over 180 consecutive days may submit a written request
to the supervisory committee to file an action with the People’s Court. Where supervisors
violate any laws, administrative regulations or the Articles of Association in their performance
of duties and cause losses to the Company, the aforesaid shareholders may submit a written
request to the Board to file an action with the People’s Court.
In the event that the supervisory committee or the Board refuses to file an action upon
receipt of the shareholders’ written request specified in the preceding paragraph, or fails to file
an action within 30 days upon receipt thereof, or in the event that the failure to immediately
file an action in an emergency case will cause irreparable damage to the interests of the
Company, the shareholders specified in the preceding paragraph may, in their own name,
directly file an action with the People’s Court for the interests of the Company.
In the event that any person infringes upon the legitimate rights and interests of the
Company and causes losses thereto, the shareholders specified in paragraph 1 of this Article
may file an action with the People’s Court pursuant to the provisions of the preceding two
paragraphs.
Where the directors, supervisors or senior management of a wholly-owned subsidiary of
the Company violate any laws, administrative regulations or the Articles of Association in their
performance of duties and cause losses to the wholly-owned subsidiary or the legitimate rights
and interests of the wholly-owned subsidiary are infringed by others, the shareholders specified
in paragraph 1 of this Article may request the supervisory committee or the Board of the
wholly-owned subsidiary in writing to file an action with the People’s Court or, in their own
name, directly file an action with the People’s Court pursuant to the provisions of the preceding
three paragraphs.
Where the directors or senior management violate any laws, administrative regulations or
the Articles of Association, thereby damaging the interests of the shareholders, the
shareholders may file an action with the People’s Court.
The shareholders of the Company shall have the following obligations:
(I) to comply with the laws, administrative regulations, and the Articles of Association;
(II) to pay subscription monies according to the number of shares subscribed and the
method of subscription;
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-6 –


--- page 687 ---
(III) not to withdraw shares unless required by the laws and regulations;
(IV) not to abuse their shareholders’ rights to harm the legitimate interests of the
Company or other shareholders; and not to abuse the independent legal person status
of the Company and the limited liability of shareholders to harm the legitimate
interests of any creditor of the Company;
(V) any other obligations imposed by the laws, administrative regulations, the securities
regulatory rules of the place where the Company’s shares are listed and the Articles
of Association.
Where shareholders of the Company who abuse their shareholders’ rights and thereby
cause losses to the Company or other shareholders shall be liable for indemnity according to
the law; where shareholders of the Company who abuse the independent legal person status of
the Company and the limited liability of shareholders for the purposes of evading repayment
of debts, thereby materially impairing the interests of the creditors of the Company, such
shareholders shall be jointly and severally liable for the debts owed by the Company.
If shareholders conduct any action stipulated in the preceding paragraph by using two or
more companies controlled by him/her, each of the company shall assume joint and several
liability for any one of the company’s debts.
Where a shareholder holding 5% or more of the voting shares of the Company pledges any
shares in his/her possession, he/she shall make a written report to the Company on the day on
which he/she pledges his/her shares.
Restriction on Rights of the Controlling Shareholders
The controlling shareholders, de facto controllers, directors, supervisors and senior
management of the Company shall not use their connections to harm the interests of the
Company. Any person who violates this provision and causes losses to the Company shall be
liable for compensation.
The controlling shareholders and de facto controllers of the Company shall have fiduciary
duties towards the Company and the public shareholders of the Company. The controlling
shareholders shall exercise their rights as contributors in strict compliance with the laws. The
controlling shareholders shall not infringe the legitimate rights and interests of the Company
and the public shareholders of the Company through profit distribution, asset restructuring,
foreign investment, capital appropriation and loan guarantee, and shall not make use of their
controlling status to jeopardize the interests of the Company and the public shareholders of the
Company.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-7 –


--- page 688 ---
General Rules of the General Meeting
The general meeting is the organ of authority of the Company and shall exercise the
following functions and powers in accordance with the laws:
(I) to elect and replace directors and supervisors and decide on matters relating to the
remuneration of directors and supervisors;
(II) to consider and approve reports of the Board;
(III) to consider and approve reports of the supervisory committee;
(IV) to consider and approve profit distribution plans and loss recovery plans of the
Company;
(V) to decide on any increase or reduction of the registered capital of the Company;
(VI) to decide on the issuance of corporate bonds;
(VII) to decide on merger, division, dissolution, liquidation and change of form of the
Company;
(VIII) to amend the Articles of Association;
(IX) to decide on the engagement or dismissal of the accounting firm of the Company and
determine its remuneration;
(X) to consider and approve the guarantees as provided below;
(XI) to consider the purchase or disposal of substantial assets of the Company with an
amount exceeding 30% of the latest audited total assets of the Company within one
year;
(XII) to consider the proposals by the shareholders severally or jointly holding one
percent or more of the voting shares of the Company;
(XIII) to consider and approve transactions between the Company and connected persons
that meet the requirements of the Hong Kong Listing Rules to be submitted to a
general meeting for approval;
(XIV) to consider other matters which are required to be determined at the general meeting
as required by the laws, administrative regulations, departmental rules, the securities
regulatory rules of the place where the Company’s shares are listed (including but
not limited to the Hong Kong Listing Rules) or the Articles of Association.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-8 –


--- page 689 ---
The following external guarantee offered by the Company shall be considered and
approved by a general meeting after considering and approving by a meeting of the Board of
Directors of the Company:
(I) guarantee provided by the Company with a guaranteed amount exceeding 30% of the
latest audited total assets of the Company within one year (excluding guarantee
between the Company and the subsidiaries of the Company);
(II) guarantee provided to shareholders, de facto controllers and their connected parties;
(III) other external guarantee matters which are required to be considered at the general
meeting as required by the laws, administrative regulations, departmental rules, the
securities regulatory rules of the place where the Company’s shares are listed
(including but not limited to the Hong Kong Listing Rules) or the Articles of
Association.
The shareholders set forth in (II) above or the shareholders who are subject to the
domination of the de facto controller set forth in (II) above shall not take part in the voting on
the matters specified in (II) above, such voting shall be considered and approved by the other
shareholders present at the meeting.
The Board shall resolve on all matters relating to external guarantees other than those
approved at general meetings.
General meetings include annual general meetings and extraordinary general meetings.
Annual general meetings shall be held once every year and within 6 months from the close of
the preceding fiscal year.
The Company shall convene an extraordinary general meeting within 2 months upon the
occurrence of the following events:
(I) the number of directors is less than the number stipulated in the Company Law or
less than two-thirds of the number as specified in the Articles of Association;
(II) the unrecovered losses of the Company amount to one-third of the total amount of
its paid-up share capital;
(III) on request by the shareholder(s) individually or collectively holding 10% or more of
the voting shares of the Company;
(IV) when the Board considers it is necessary;
(V) when the supervisory committee proposes to convene;
(VI) other circumstances as stipulated by the laws, administrative regulations,
departmental rules, the securities regulatory rules of the place where the Company’s
shares are listed or the Articles of Association.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-9 –


--- page 690 ---
Convening of General Meetings
General meetings shall be called by the Board in accordance with the laws.
The independent non-executive directors shall have the right to propose to the Board to
convene an extraordinary general meeting. In response to a proposal by an independent
non-executive director to convene an extraordinary general meeting, the Board shall, in
accordance with the laws, administrative regulations, the securities regulatory rules of the
place where the Company’s shares are listed and the Articles of Association, give a written
response as to whether or not it agrees to convene an extraordinary general meeting within 10
days upon receipt of such proposal. Where the Board agrees to convene the extraordinary
general meeting, a convening notice will be issued within 5 days after the resolution of the
Board is made; where the Board disagrees to convene the extraordinary general meeting,
reasons shall be specified.
The supervisory committee shall have the right to propose to the Board to convene an
extraordinary general meeting and such proposal shall be made to the Board in writing. The
Board shall, in accordance with the laws, administrative regulations, the securities regulatory
rules of the place where the Company’s shares are listed and the Articles of Association, give
a written response as to whether or not it agrees to convene an extraordinary general meeting
within 10 days upon receipt of such proposal.
Where the Board agrees to convene the extraordinary general meeting, a convening notice
will be issued within 5 days after the resolution of the Board is made, and the changes made
to the original proposal in the notice shall be approved by the supervisory committee.
Where the Board disagrees to convene the extraordinary general meeting, or fails to reply
within 10 days upon the receipt of such proposal, the Board will be deemed as not being able
to perform or not to perform its duty to convene a general meeting, and the supervisory
committee may convene and preside over such meeting on their own.
The shareholder(s) severally or jointly holding 10% or more of the voting shares of the
Company shall have the right to propose to the Board to convene an extraordinary general
meeting and such proposal shall be made to the Board in writing. The written proposal shall
state the subject of the meeting and present a complete proposal. The Board shall, in
accordance with the laws, administrative regulations, the securities regulatory rules of the
place where the Company’s shares are listed (including but not limited to the Hong Kong
Listing Rules) and the Articles of Association, give a written response as to whether or not it
agrees to convene an extraordinary general meeting within 10 days upon receipt of such
proposal.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-10 –


--- page 691 ---
Where the Board agrees to convene the extraordinary general meeting, a convening notice
shall be issued within 5 days after the resolution of the Board is made, and the changes made
to the original proposal in the notice shall be approved by the relevant shareholders. If the laws,
administrative regulations, departmental rules and the securities regulatory rules of the place
where the Company’s shares are listed have any other provisions, such provisions shall prevail.
The subject of the meeting proposed by the convening requestor shall be included in the agenda
of the extraordinary general meeting.
Where the Board disagrees to convene the extraordinary general meeting, or fails to reply
within 10 days upon receipt of such proposal, the shareholder(s) individually or collectively
holding 10% or more of the voting shares of the Company shall have the right to propose to
the supervisory committee to convene an extraordinary general meeting and such proposal
shall be made to the supervisory committee in writing.
Where the supervisory committee agrees to convene the extraordinary general meeting, a
convening notice shall be issued within 5 days upon receipt of the proposal, and the changes
made to the original proposal in the notice shall be approved by the relevant shareholders. If
the laws, administrative regulations, departmental rules and the securities regulatory rules of
the place where the Company’s shares are listed have any other provisions, such provisions
shall prevail. The subject of the meeting proposed by the convening requestor shall be included
in the agenda of the extraordinary general meeting.
Where the supervisory committee fails to issue the notice of the general meeting within
the prescribed period, the supervisory committee will be deemed as not being able to convene
or not to preside over the general meeting, and the shareholder(s) individually or collectively
holding 10% or more of the voting shares of the Company for 90 or more consecutive days may
convene and preside over such meeting on their own.
If the supervisory committee or the shareholder(s) decides to convene a general meeting
on his/her/its own, he/she/it shall notify the Board in writing and shall give notice of such
meeting to the shareholders in accordance with the applicable requirements such as the Hong
Kong Listing Rules.
Prior to the formation of the resolutions adopted at such general meeting, the shareholders
convening such meeting shall hold at least 10% of the voting shares of the Company.
Proposals of General Meetings
The Board, the supervisory committee, and shareholder(s) severally or jointly holding
more than 1% of the voting shares of the Company shall have the right to make a proposal to
the Company at a general meeting of the Company.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-11 –


--- page 692 ---
The shareholder(s) severally or jointly holding more than 1% of the voting shares of the
Company may make provisional proposals in writing to the convener of a general meeting 10
days prior to such meeting. The convener shall issue a supplementary notice of the general
meeting and announce the contents of such provisional proposals within 2 days upon receipt
thereof, unless the provisional proposal does not comply with the Articles of Association.
Except as provided by the preceding paragraph and laws, administrative regulations and
the securities regulatory rules of the place where the Company’s shares are listed, the convener
of a general meeting shall not amend the proposals already specified in the notice of the general
meeting or add new proposals subsequent to the issue of the notice of the general meeting.
Proposals which are not specified in the notice of the general meeting or which do not
comply with the Articles of Association shall not be voted on and resolved at the general
meeting.
Notices of General Meetings
The convener shall notify all shareholders by written notice (including announcement) no
later than 21 days prior to the date of convening the annual general meeting and no later than
15 days prior to the date of convening the extraordinary general meeting. If the laws,
administrative regulations, departmental rules and the securities regulatory rules of the place
where the Company’s shares are listed (including but not limited to the Hong Kong Listing
Rules) have any other provisions, such provisions shall prevail.
The date of the meeting shall be excluded when the Company calculates the starting date.
Holding of General Meetings
All shareholders or their proxies recorded in the register on the record date shall have the
right to attend general meetings, and they are entitled to speak and vote at general meetings in
accordance with the relevant laws, regulations, the securities regulatory rules of the place
where the Company’s shares are listed and the Articles of Association. Shareholders may attend
general meetings in person or appoint their proxies to attend, speak and vote on their behalf.
A proxy does not need to be a shareholder of the Company. Shareholders shall have the right
to speak and vote at general meetings, unless individual shareholders are required by the
securities regulatory rules of the place where the Company’s shares are listed (including but not
limited to the Hong Kong Listing Rules) to abstain from voting on specific matters.
Individual shareholders attending the meeting in person shall present his/her
identification card or other valid documents or proof of his/her identification and certificate of
shareholding. In the case of attendance by proxies, they shall present his/her valid
identification documents and the proxy forms from the shareholders.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-12 –


--- page 693 ---
Legal person shareholders or other institutional shareholders shall be represented at the
meeting by their legal representatives/executive partners or proxies appointed by the legal
representatives/executive partners. In the case of attendance by legal representatives/executive
partners, they shall present their identity cards, valid proof of their capacities as legal
representatives/executive partners; in the case of attendance by proxies, they shall present their
identity cards and written authorization letters issued by such legal representatives/executive
partners of the legal person shareholders or institutional shareholders, unless the shareholder
is a recognized clearing house (or its proxy) as defined in the relevant ordinances enacted in
Hong Kong from time to time.
If the shareholder is a recognized clearing house (or its proxy) as defined in the relevant
ordinances promulgated in Hong Kong from time to time, the shareholder may authorize one
or more persons as he/she thinks fit to act as his/her proxy or representative(s) at any general
meeting (and/or any meeting of creditors). However, if more than one person is authorized, the
power of attorney shall state the number and class of shares in respect of which each such
person is authorized and shall be signed by the authorized officer of a recognized clearing
house. A person so authorized is entitled to attend meetings and exercise the rights (including
the right to speak and vote) on behalf of the recognized clearing house (or its proxy) (without
the need to produce a certificate of shareholding, notarized power of attorney and/or further
evidence of formal authorization), as if they were the individual shareholders of the Company.
Such authorized person shall be entitled with the same statutory rights as other shareholders,
including the right to speak and vote.
It shall be stated clearly in the power of attorney if the shareholder proxy can vote at
his/her discretion when the shareholder does not give any specific instructions.
Voting and Resolutions at General Meetings
The resolutions of general meetings shall be divided into ordinary resolutions and special
resolutions. Ordinary resolutions of a general meeting shall be approved by more than one half
of the voting rights held by the shareholders (including proxies thereof) present at the general
meeting. special resolutions of a general meeting shall be approved by more than two-thirds of
the voting rights held by the shareholders (including proxies thereof) present at the general
meeting.
The following matters shall be approved by ordinary resolutions at the general meeting:
(I) work reports of the Board and the supervisory committee;
(II) profit distribution plans and loss recovery plans drafted by the Board;
(III) appointment or dismissal of the members of the Board and the supervisory
committee, and determination of the remuneration of the Board and the supervisory
committee;
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-13 –


--- page 694 ---
(IV) issuance of corporate bonds;
(V) annual reports of the Company;
(VI) engagement or dismissal of the accounting firm, and determination of the
remuneration of the accounting firm;
(VII) connected transactions between the Company and connected persons that meet the
requirements of the Hong Kong Listing Rules to be submitted to a general meeting
for approval; and
(VIII) matters other than those approved by special resolution as stipulated by the laws,
administrative regulations, the securities regulatory rules of the place where the
Company’s shares are listed (including but not limited to the Hong Kong Listing
Rules) or the Articles of Association.
The following matters shall be approved by special resolutions at the general meeting:
(I) the increase or decrease of the registered capital of the Company;
(II) division, spin-off, merger, termination, dissolution, liquidation and change in the
form of the Company;
(III) amendments to the Articles of Association;
(IV) purchase and disposal of substantial assets by the Company within one year, or a
guaranteed amount exceeding 30% of the latest audited total assets of the Company;
(V) other matters as required by the laws, administrative regulations, the securities
regulatory rules of the place where the Company’s shares are listed (including but
not limited to the Hong Kong Listing Rules) or the Articles of Association, and
confirmed by an ordinary resolution at a general meeting that it may have a material
impact on the Company and accordingly shall be approved by special resolutions.
In accordance with the applicable laws, administrative regulations, departmental rules,
normative documents and the securities regulatory rules of the place where the Company’s
shares are listed, where any shareholder shall abstain from voting for any particular resolution,
or is restricted to vote only for or against such resolution, any votes in violation of such
requirement or restriction by the shareholders (or their proxies) shall not be counted in the
voting results.
The shares of the Company held by it have no voting rights, and such portion of shares
shall not be counted in the total number of voting shares present at the general meeting.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-14 –


--- page 695 ---
Where matters relating to connected transactions (as defined under the Hong Kong
Listing Rules) are considered at the general meeting, the connected shareholders and their
associates (as defined under the Hong Kong Listing Rules) shall not be involved in voting, and
the voting shares they represent shall not be counted in the total number of valid voting rights.
The voting particulars of the non-connected persons shall be fully disclosed in the
announcement on the resolution of the general meeting.
In order to be valid, the resolution of the general meeting on matters relating to connected
transactions shall be approved by more than one half of the voting rights held by the
non-connected persons attending the general meeting. However, in the event of such connected
transaction involving matters that are required to be approved by special resolution stipulated
in the Articles of Association, in order to be valid, the resolution of the general meeting must
be approved by more than two-thirds of the voting rights held by the non-connected persons
attending the general meeting.
DIRECTORS AND THE BOARD
Directors
Directors of the Company shall be natural persons. The following person may not serve
as a director of the Company:
(I) a person without capacity or with limited capacity for civil conduct;
(II) a person who has been sentenced to criminal punishment for corruption, bribery,
infringement of property, misappropriation of property or for damaging the order of
the socialist market economy, where less than five years have elapsed since the
sentence was served, or who has been deprived of his/her political rights due to
criminal offense, where less than 5 years have elapsed since the sentence was
served, or where less than 2 years have elapsed since the date of expiration of the
probationary period if such person is sentenced to probation;
(III) a person who served as a director, or factory director or manager, and who assumed
personal liability for the bankruptcy liquidation of a company or enterprise, where
less than 3 years have elapsed since the date of completion of the bankruptcy
liquidation of such company or enterprise;
(IV) a person who served as a legal representative of a company or enterprise which had
its business license revoked and was ordered to close down due to violation of law,
and who assumed personal liability for such violation, where less than 3 years have
elapsed since the date of the revocation of business license of such company or
enterprise;
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-15 –


--- page 696 ---
(V) a person who has a relatively large amount of debts which have fallen due but have
not been settled and was listed as a dishonest person subject to enforcement by the
People’s Court;
(VI) a person who is banned by the CSRC from entering into the securities market for a
period which has not yet expired;
(VII) other contents required by the laws, administrative regulations, departmental rules,
the securities regulatory rules of the place where the Company’s shares are listed
(including but not limited to the Hong Kong Listing Rules).
Directors shall be elected or replaced at a general meeting and he/she may be dismissed
at a general meeting before the expiry of his/her term of office. Directors serve a term of office
of 3 years for each session. A director may be re-elected and reappointed upon the expiry of
his/her term of office, unless otherwise stipulated by the relevant laws, regulations and the
securities regulatory rules of the place where the Company’s shares are listed.
The term of office of a director shall commence from the date on which the said director
assumes office to the expiry of the current term of the Board. If the term of office of a director
expires but re-election is not carried out in a timely manner, the said director shall continue to
perform the duties as director pursuant to the laws, administrative regulations, departmental
rules, the securities regulatory rules of the place where the Company’s shares are listed
(including but not limited to the Hong Kong Listing Rules) and the Articles of Association until
the elected director assumes his/her office. Any person appointed by the Board to fill a
temporary vacancy on or as an addition to the Board shall hold office only until the first annual
general meeting immediately following his/her appointment, and shall then be eligible for
re-election, provided that the securities regulatory rules of the place where the Company’s
shares are listed (including but not limited to the Hong Kong Listing Rules), applicable laws,
regulations and regulatory rules are not violated. Subject to the relevant laws and
administrative regulations, the shareholders have the right to dismiss a director whose term of
office has not expired by an ordinary resolution at a general meeting, but such dismissal shall
not affect the director’s claim for damages under any contract.
There are no employee representative directors in the Company. The general manager or
other senior management may concurrently serve as directors.
Duties of Directors
Directors shall comply with the laws, administrative regulations, the securities regulatory
rules of the place where the Company’s shares are listed and the Articles of Association, and
bear the following duties of loyalty to the Company:
(I) not to exploit their positions to accept bribes or obtain other illegal income;
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-16 –


--- page 697 ---
(II) not to expropriate the property of the Company, not to misappropriate the funds of
the Company;
(III) not to open any account in their own name or in any other name for the deposit of
the assets or funds of the Company;
(IV) not to take as their own any commission for any transaction with the Company;
(V) not to disclose any secret of the Company without authorization;
(VI) not to use their connected relationships to harm the interests of the Company;
(VII) other duties of loyalty as stipulated by the laws, administrative regulations,
departmental rules, the securities regulatory rules of the place where the Company’s
shares are listed and the Articles of Association.
Directors shall comply with the laws, administrative regulations, departmental rules,
normative documents, the Hong Kong Listing Rules and the Articles of Association, and fulfill
the obligations of diligence to the Company, and exercise the reasonable care normally
expected of a manager in the best interests of the Company in the performance of their duties.
Where a director directly or indirectly enters into a contract or transaction with the
Company, he/she shall report the matters relating to the entering of the contract or transaction
to the Board or the general meeting, and the contract or transaction shall be subject to the
approval of the Board or the general meeting in accordance with the laws, regulations and the
securities regulatory rules of the place where the Company’s shares are listed.
The provisions above shall be applicable to the close family members of the directors, the
enterprises directly or indirectly controlled by the directors or their close family members, and
the related persons who have other related relationships with the directors when they enter into
contracts or conduct transactions with the Company.
Directors shall not use their position to seek business opportunities that belong to the
Company for themselves or others, except in any of the following circumstances:
(I) reporting to the Board or the general meeting and being approved by a resolution of
the Board or the general meeting in accordance with the laws, regulations and the
securities regulatory rules of the place where the Company’s shares are listed;
(II) where the Company is not permitted to make use of the business opportunity in
accordance with the laws, administrative regulations or the Articles of Association.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-17 –


--- page 698 ---
Directors, without reporting to the Board or the general meeting and being approved by
a resolution of the Board or the general meeting in accordance with the laws, regulations and
the securities regulatory rules of the place where the Company’s shares are listed, shall not
engage in or operate a business similar to that of the Company either on their own account or
for others.
The Board
The Company shall set up a board of directors, which shall be accountable to the general
meeting. Directors of the Company are classified as executive directors, non-executive
directors and independent non-executive directors, and the number of independent non-
executive directors shall comprise at least one-third of the members of the Board and shall not
be less than 3 members.
The Board exercises the following functions and powers:
(I) to convene general meetings and report on work to the general meeting;
(II) to implement the resolutions of the general meeting;
(III) to determine the business plans and investment plans of the Company;
(IV) to formulate the profit distribution plans and loss recovery plans of the Company;
(V) to formulate plans for increasing or decreasing the registered capital of the
Company, the issuance of bonds or other securities, as well as the listing plan of the
Company;
(VI) to formulate plans for merger, division, dissolution or change of form of the
Company;
(VII) to decide on the setup of the internal management organization of the Company;
(VIII) to appoint or dismiss the general manager of the Company, and determine their
remunerations; based on the nomination of the general manager, to appoint or
dismiss other senior management of the Company, and determine their
remunerations;
(IX) to set the basic management systems of the Company;
(X) other functions and powers authorized by the laws, administrative regulations,
departmental rules, the securities regulatory rules of the place where the Company’s
shares are listed (including but not limited to the Hong Kong Listing Rules) or the
Articles of Association.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-18 –


--- page 699 ---
The Board of the Company shall establish the special committees, namely, an audit
committee, a nomination committee and a remuneration committee. The special committees
shall be accountable to the Board and perform their duties in accordance with the Articles of
Association and the authorization from the Board. Their proposals shall be submitted to the
Board for consideration and decision making. The members of each special committee shall all
be directors, with reference to the laws, administrative regulations, departmental rules, and the
regulatory rules of the place where the Company’s shares are listed (including but not limited
to the Hong Kong Listing Rules) for specific composition and qualification requirements. The
Board of Directors is responsible for formulating the working rules of the special committees
and regulating the operation of the special committees.
The chairman of the Board exercises the following functions and powers:
(I) to preside over general meetings, and to convene and preside over the Board
meetings;
(II) to supervise and inspect the implementation of the resolutions of the Board;
(III) other functions and powers granted by the Board.
Board meetings shall be classified into regular meetings and extraordinary meetings. The
Board shall convene regular meetings at least 4 times a year, which shall be held approximately
once each quarter and convened by the chairman of the Board. The written notice of the regular
meeting shall be delivered 14 days before the date of the meeting. The chairman of the Board
shall hold at least one meeting with the independent non-executive directors without the
presence of other directors each year.
An extraordinary meeting of the Board shall be convened and presided over by the
chairman of the Board within 10 days after the receipt of such proposal under any of the
following circumstances:
(I) when it is proposed by more than 1/10 of the shareholders with voting rights;
(II) when it is jointly proposed by more than 1/3 of directors;
(III) when it is proposed by the supervisory committee;
(IV) when the chairman of the Board deems it necessary;
(V) at the request of the relevant securities regulatory authorities;
(VI) other circumstances as stipulated by the Articles of Association.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-19 –


--- page 700 ---
A Board meeting may be held only when a majority of the directors are present at the
meeting. A resolution of the Board meeting must be approved with affirmative votes of a
majority of all directors.
Directors shall attend Board meetings in person, or actively participate through electronic
means. If a director cannot attend the meeting for any reason, he/she may authorize in writing
another director to act on his/her behalf. The power of attorney shall set out the name of the
proxy, the matters represented, scope of authorization and validity period, and shall be signed
or sealed by the appointing director. The appointed director who attends the meeting shall
exercise the director’s duties within the scope of authorization. If a director does not attend a
Board meeting in person and does not appoint a proxy to attend the meeting, he/she shall be
deemed to have waived the voting rights at the meeting.
SENIOR MANAGEMENT
The Company shall have one general manager, one chief financial officer and one
secretary to the Board of whom shall be appointed or dismissed by the Board. In the future, the
Company may decide to appoint other senior management according to the actual operational
development needs.
Each term of office of the general manager is 3 years and is renewable upon re-election
of the Board.
The general manager is accountable to the Board and exercises the following functions
and powers:
(I) to be in charge of the production and operational management of the Company,
organize the enforcement of resolutions of the Board and report to the Board on
work;
(II) to organize the implementation of the annual operation plans and investment
schemes of the Company;
(III) to formulate the structure scheme of the internal management department of the
Company;
(IV) to formulate the specific rules and regulations of the Company;
(V) to propose to the Board the appointment or dismissal of the chief financial officer
of the Company and other senior management;
(VI) to decide on the appointment or dismissal of responsible management personnel
except those whose appointment or dismissal shall be determined by the Board;
(VII) other functions and powers authorized by the Articles of Association or the Board.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-20 –


--- page 701 ---
SUPERVISORS AND SUPERVISORY COMMITTEE
The Company shall have a supervisory committee, which shall be composed of 3
supervisors, with 1 chairman. The chairman of the supervisory committee shall be elected by
a majority of all directors. Meetings of the supervisory committee shall be convened and
presided over by the chairman of the supervisory committee; if the chairman of the supervisory
committee is unable or fails to perform his/her duties, a supervisor who has been elected by
more than one half of the supervisors shall convene and preside over the meeting of the
supervisory committee.
The supervisory committee exercises the following functions and powers:
(I) to examine the financial operations of the Company;
(II) to supervise the performance of duties to the Company by the directors and senior
management, and propose dismissal of any director or senior management who
violates any laws, administrative regulations, the Articles of Association or
resolutions of the general meeting;
(III) to require directors and senior management to make corrections if their conduct has
damaged the interests of the Company;
(IV) to propose the convening of an extraordinary general meeting, and to convene and
preside over the general meeting when the Board fails to perform such duties as
specified in the Company Law;
(V) to submit proposals to the general meeting;
(VI) to institute legal proceedings against the directors and senior management according
to the Company Law;
(VII) in the event that the supervisory committee discovers any unusual operation of the
Company, it may conduct an investigation and, when necessary, professionals, such
as accounting firms and law firms, may be engaged to assist in its work; any
expenses incurred thereby shall be borne by the Company;
(VIII) other functions and powers authorized by the general meeting.
The supervisory committee shall hold at least one meeting every six months. The written
notice (including by post, email, fax or personal delivery) shall be delivered 10 days before the
date of the meeting. A meeting of the supervisory committee may be held only when a majority
of the supervisors are present at the meeting.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-21 –


--- page 702 ---
A supervisor may propose to convene an extraordinary meeting of the supervisory
committee. The written notice of the extraordinary meeting of the supervisory committee shall
be delivered 5 days before the date of the meeting. With the unanimous consent of all
supervisors of the Company, the time limit for notification stipulated in the preceding
paragraph may be waived.
FINANCIAL AND ACCOUNTING SYSTEM, PROFIT DISTRIBUTION AND AUDIT
Financial and Accounting System
The Company shall establish its financial and accounting system in accordance with the
laws, administrative regulations and the requirements of the relevant authorities of China. If
the securities regulatory authorities of the place where the Company’s shares are listed have
any other provisions, such provisions shall prevail.
The Company shall not establish any other accounting books except for the statutory
ones. No assets of the Company shall be deposited in any account opened in the name of any
individual.
Profit Distribution
In distributing the after-tax profit of the current year, the Company shall withdraw 10%
of the profit as its statutory reserve funds. When the aggregate amount of the statutory reserve
funds of the Company is more than 50% of its registered capital, further appropriations are not
required.
Where the statutory reserve funds of the Company are insufficient to make up for the
losses of the previous year, the profits of the current year shall be used to make up for such
losses before making allocation to its statutory reserve funds in accordance with the preceding
paragraph.
After withdrawing the statutory reserve funds from after-tax profit, the Company may,
subject to a resolution of the general meeting, withdraw the discretionary reserve funds from
after-tax profit.
After making up for the losses and making allocations to the reserve funds, any remaining
after-tax profit shall be distributed by the Company to the shareholders in proportion to their
respective shareholdings.
The shares of the Company held by it are not entitled to any profit distribution.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-22 –


--- page 703 ---
Reserve funds of the Company shall be used for making up for the losses, business
expansion for operation or registered capital replenishment of the Company. When using the
reserve funds to make up for the losses of the Company, the discretionary reserve funds and
the statutory reserve funds shall be used first; if the losses still cannot be made up, the capital
reserve funds can be used in accordance with the requirements.
When the statutory reserve funds are converted into the capital, the remaining amount of
such reserve funds shall not be less than 25% of the registered capital of the Company before
the conversion.
Engagement of Accounting Firms
The Company shall engage an accounting firm which complies with the laws and
regulations to conduct accounting statements audit, net assets verification and other relevant
consultancy services, which is subject to renewal.
The appointment of any accounting firm of the Company shall be subject to the approval
of the general meeting, prior to which the Board shall not appoint any accounting firm.
When the Company intends to dismiss or not to reappoint an accounting firm, it shall give
15 days prior notice to the accounting firm. When a general meeting of the Company votes on
the dismissal of the accounting firm, the firm shall be allowed to represent its opinions.
NOTICES
The notices of the Company may be served as follows:
(I) by personal delivery;
(II) by fax, email or post;
(III) by telephone;
(IV) by announcement (including on the designated website and the website of the
Company in accordance with the securities regulatory rules of the place where the
Company’s shares are listed);
(V) by other means as specified by the securities regulatory authorities of the place
where the Company’s shares are listed or the Articles of Association.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-23 –


--- page 704 ---
MERGER, DIVISION, CAPITAL INCREASE AND CAPITAL REDUCTION
In the event of a merger, the parties to the merger shall enter into a merger agreement, and
prepare balance sheets and inventories of assets. The Company shall notify the creditors within
10 days from the date of the resolution to merge and publish an announcement within 30 days
in accordance with the requirements. The creditors may require the Company to settle the debts
or provide appropriate guarantees within 30 days after the receipt of the notice or within 45
days after the date of the announcement if the creditors have not received the notice.
In the event of a division, balance sheets and inventories of assets shall be prepared. The
Company shall notify the creditors within 10 days from the date of the resolution to divide and
publish an announcement within 30 days in accordance with the requirements.
The Company shall prepare balance sheets and inventories of assets when it needs to
reduce its registered capital.
The Company shall notify the creditors within 10 days from the date of the resolution to
reduce its registered capital and publish an announcement within 30 days in accordance with
the requirements. The creditors may require the Company to settle the debts or provide
appropriate guarantees within 30 days after the receipt of the notice or within 45 days after the
date of the announcement if the creditors have not received the notice.
Where a merger or division of the Company involves any changes to any registration, an
application for modification of registration shall be made to the Company’s registration
authority pursuant to the laws; where the Company is dissolved, the Company shall apply for
cancellation of its registration in accordance with the laws; where a new company is
established, the Company shall apply for registration thereof in accordance with the laws.
Where the Company increases or reduces its registered capital, an application for
modification of registration shall be made to the Company’s registration authority pursuant to
the laws.
Dissolution and Liquidation
In any of the following circumstances, the Company shall be dissolved:
(I) the term of business operation set out in the Articles of Association has expired or
other events of dissolution specified in the Articles of Association have occurred;
(II) a resolution for dissolution is passed at a general meeting;
(III) dissolution is necessary due to a merger or division of the Company;
(IV) the business license is revoked, the Company is ordered to close or is eliminated
according to the laws;
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-24 –


--- page 705 ---
(V) the Company has experienced material difficulties in operation and management,
and the continuous operation would lead to substantial losses to the interests of its
shareholders and there are no other solutions to resolve the matters. Shareholders
holding 10% or more of the total voting rights of the Company may appeal to the
People’s Court for dissolution of the Company.
The Company shall, within ten days of the occurrence of the reasons for dissolution as
stipulated in the preceding paragraph, disclose the reasons for dissolution on the National
Enterprise Credit Information Publicity System.
In the circumstances set forth in (I) and (II) above, and where no property has been
distributed to shareholders, the Company may carry on its existence by amending the Articles
of Association or by resolution of the general meeting.
The amendments to the Articles of Association pursuant to the preceding paragraph or by
resolution of the general meeting shall require approval of more than 2/3 of voting rights of
shareholders attending a general meeting.
Where the Company is dissolved pursuant to (I), (II), (IV) and (V) above, a liquidation
committee shall be formed within 15 days from the date of occurrence of such grounds for
dissolution to start the liquidation process. The composition of the liquidation committee shall
be determined by directors or the general meeting. In case no such committee is established to
timely proceed with liquidation, the creditors may make an application to the People’s Court
for appointing relevant persons to form the liquidation committee for liquidation.
The liquidation committee exercises the following functions and powers during the
liquidation period:
(I) to sort out the assets of the Company and prepare balance sheets and inventories of
assets respectively;
(II) to notify creditors by notice or public announcements;
(III) to deal with and settle any outstanding businesses of the Company;
(IV) to pay outstanding taxes as well as taxes arising in the course of liquidation;
(V) to settle claims and debts;
(VI) to allocate the remaining assets of the Company after the repayment of debts;
(VII) to represent the Company in any civil proceedings.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-25 –


--- page 706 ---
The liquidation committee shall notify the creditors within 10 days from the date of its
establishment and publish an announcement within 60 days in accordance with the
requirements. The creditors shall declare their claims to the liquidation committee within 30
days after the receipt of the notice or within 45 days after the date of the announcement if the
creditors have not received the notice.
When declaring the claims, the creditors shall specify the relevant matters about the
claims and provide corresponding evidence. The liquidation committee shall register such
claims.
During the period of declaration of claims, the liquidation committee shall not repay any
debts to the creditors.
After sorting out the assets of the Company and preparing balance sheets and inventories
of assets, the liquidation committee shall formulate a liquidation plan and present it to the
general meeting or to the People’s Court for confirmation.
The remaining assets of the Company after repayment of liquidation expenses, staff
wages and social insurance expenses and statutory compensation, payment of outstanding
taxes, and payment of the debts of the Company shall be distributed by the Company to the
shareholders in proportion to their respective shareholdings.
During the liquidation, the Company shall continue to exist but shall not commence any
business activities unrelated to the liquidation. The assets of the Company shall not be
distributed to the shareholders before repayment of its debts in full in accordance with the
preceding paragraph.
If, after sorting out the assets of the Company and preparing balance sheets and
inventories of assets, the liquidation committee discovers that the assets of the Company are
insufficient to repay its debts in full, it shall apply to the People’s Court for bankruptcy in
accordance with the laws.
After the People’s Court has ruled that the Company is declared bankrupt, the liquidation
committee shall hand over the liquidation matters to the bankruptcy administrator designated
by the People’s Court.
Upon completion of the liquidation of the Company, the liquidation committee shall
prepare a liquidation report and submit to the general meeting or the People’s Court for
confirmation. The liquidation committee shall submit the foregoing documents to the
Company’s registration authority and apply for deregistration of the Company.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-26 –


--- page 707 ---
AMENDMENTS TO THE ARTICLES OF ASSOCIATION
The Company shall amend the Articles of Association in any of the following
circumstances:
(I) after amendment has been made to the Company Law or relevant laws,
administrative regulations and the securities regulatory rules of the place where the
Company’s shares are listed, the contents of the Articles of Association are in
conflict with the amended laws, administrative regulations or securities regulatory
rules of the place where the Company’s shares are listed;
(II) the changes that the Company have undergone are inconsistent with the records
made in the Articles of Association;
(III) the general meeting has resolved to amend the Articles of Association.
Where the amendments to the Articles of Association approved by the general meetings
are subject to the examination and approval by the competent authorities, such amendments
shall be submitted to the competent authorities for approval. Where the amendments involve
registration of the Company, the Company shall register relevant changes according to the
laws.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-27 –


--- page 708 ---
FURTHER INFORMATION ABOUT OUR COMPANY
Establishment of our Company
Our Company was established as a limited liability company in the PRC on August 23,
2017 and was converted into a joint stock company with limited liability on September 29,
2024 under the laws of the PRC. As of the Latest Practicable Date, the registered share capital
of our Company is RMB26,774,063.
Our Company has established a place of business in Hong Kong at 46/F., Hopewell
Centre, 183 Queen’s Road East, Wan Chai, Hong Kong and has been registered as a non-Hong
Kong company in Hong Kong under Part 16 of the Companies Ordinance on December 18,
2024. Mr. NG Tung Ching Raphael, one of our joint company secretaries, has been appointed
as the authorized representative in Hong Kong and our agent for the acceptance of service of
process in Hong Kong whose correspondence address is the same as our place of business in
Hong Kong.
As we are established in the PRC, our corporate structure and Articles of Association are
subject to the relevant laws and regulations of the PRC. A summary of the relevant provisions
of our Articles of Association is set out in “Summary of Articles of Association” in
Appendix III.
Changes in Share Capital of Our Company
The changes in the share capital of our Company during the two years immediately
preceding the date of this Prospectus is set out as follows:
On January 6, 2024, the registered capital of our Company increased from
RMB25,100,255.68 to RMB26,774,062.58.
Save as aforesaid, as of the Latest Practicable Date, there had been no alterations of our
share capital within the two years preceding the date of publication of this Prospectus.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-1 –


--- page 709 ---
Changes in Share Capital of Our Subsidiaries
A summary of the corporate information and the particulars of our subsidiaries are set out
in the Accountants’ Report in Appendix I. There had been no other alterations of share capital
of our subsidiaries within the two years preceding the date of this Prospectus.
Resolutions of our Shareholders
Pursuant to a general meeting held on December 3, 2024, among other things, our
Shareholders resolved that:
(a) the issuance by our Company of the H Shares of nominal value of RMB0.1 each and
such H Shares being listed on the Hong Kong Stock Exchange;
(b) the sub-division of the Shares with nominal value of RMB1.0 each on the basis of
1:10, effective immediately prior to the Listing, and taking into account the Share
Subdivision, the issue of H Shares of nominal value of RMB0.1 each and such H
Shares be listed on the Stock Exchange;
(c) the number of H Shares to be issued shall not be more than 25% of the total issued
share capital of our Company as enlarged by the Global Offering, and the grant to
the underwriters (or their representatives) of the Over-allotment Option of not more
than 15% of the number of H Shares issued pursuant to the Global Offering;
(d) authorization of the Board to handle matters relating to, among other things, the
Global Offering, the issue and listing of the H Shares; and
(e) subject to the completion of the Global Offering, the conditional adoption of the
Articles of Association, which shall become effective on the Listing Date and the
authorization of the Board to amend the Articles of Association in accordance with
relevant laws and regulations and upon the request from the Stock Exchange and
relevant PRC regulatory authorities.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-2 –


--- page 710 ---
FURTHER INFORMATION ABOUT OUR BUSINESS
Summary of Material Contracts
We have entered into the following contracts (not being contracts entered into in the
ordinary course of business) within the two years immediately preceding the date of this
Prospectus that are or may be material:
(a) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, RTW Master Fund, Ltd., RTW Innovation Master Fund, Ltd., RTW
Biotech Opportunities Ltd, CITIC Securities (Hong Kong) Limited, CLSA Limited
and China Renaissance Securities (Hong Kong) Limited, details of which are set out
in the section headed “Cornerstone Investors” in this Prospectus;
(b) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, TruMed Healthcare Master Fund, CITIC Securities (Hong Kong)
Limited and CLSA Limited, details of which are set out in the section headed
“Cornerstone Investors” in this Prospectus;
(c) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, TruMed Health Innovation Fund LP , CITIC Securities (Hong Kong)
Limited and CLSA Limited, details of which are set out in the section headed
“Cornerstone Investors” in this Prospectus;
(d) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, OrbiMed Genesis Master Fund, L.P ., The Biotech Growth Trust PLC,
OrbiMed Partners Master Fund Limited, CITIC Securities (Hong Kong) Limited,
CLSA Limited and China Renaissance Securities (Hong Kong) Limited, details of
which are set out in the section headed “Cornerstone Investors” in this Prospectus;
(e) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, UBS Asset Management (Singapore) Ltd. (as the delegate of the
investment manager for and on behalf of the investors listed in the agreement),
CITIC Securities (Hong Kong) Limited and CLSA Limited, details of which are set
out in the section headed “Cornerstone Investors” in this Prospectus;
(f) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, Vivo Opportunity Fund Holdings, L.P ., CITIC Securities (Hong Kong)
Limited, CLSA Limited and China Renaissance Securities (Hong Kong) Limited,
details of which are set out in the section headed “Cornerstone Investors” in this
Prospectus;
(g) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, Vivo Opportunity Cayman Fund, L.P ., CITIC Securities (Hong Kong)
Limited, CLSA Limited and China Renaissance Securities (Hong Kong) Limited,
details of which are set out in the section headed “Cornerstone Investors” in this
Prospectus;
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-3 –


--- page 711 ---
(h) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, China Universal Asset Management Company Limited, CITIC
Securities (Hong Kong) Limited and CLSA Limited, details of which are set out in
the section headed “Cornerstone Investors” in this Prospectus;
(i) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, China Universal Asset Management (Hong Kong) Company Limited
(as the investment manager for and on behalf of the investors listed in the
agreement), CITIC Securities (Hong Kong) Limited and CLSA Limited, details of
which are set out in the section headed “Cornerstone Investors” in this Prospectus;
(j) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, Fullgoal Fund Management Co., Ltd., CITIC Securities (Hong Kong)
Limited and CLSA Limited, details of which are set out in the section headed
“Cornerstone Investors” in this Prospectus;
(k) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, Fullgoal Asset Management (HK) Limited, CITIC Securities (Hong
Kong) Limited and CLSA Limited, details of which are set out in the section headed
“Cornerstone Investors” in this Prospectus;
(l) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, CITIC Securities International Capital Management Limited, CITIC
Securities (Hong Kong) Limited and CLSA Limited, details of which are set out in
the section headed “Cornerstone Investors” in this Prospectus;
(m) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, Lake Bleu Prime Healthcare Master Fund Limited, CITIC Securities
(Hong Kong) Limited and CLSA Limited, details of which are set out in the section
headed “Cornerstone Investors” in this Prospectus;
(n) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, Lake Bleu Innovation Healthcare Master Fund Limited, CITIC
Securities (Hong Kong) Limited and CLSA Limited, details of which are set out in
the section headed “Cornerstone Investors” in this Prospectus;
(o) the cornerstone investment agreement dated September 9, 2025 entered into among
the Company, LBC HK Opportunity Fund Limited, CITIC Securities (Hong Kong)
Limited and CLSA Limited, details of which are set out in the section headed
“Cornerstone Investors” in this Prospectus; and
(p) the Hong Kong Underwriting Agreement.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-4 –


--- page 712 ---
Intellectual Property Rights
As of the Latest Practicable Date, our Group has registered, or has applied for the
registration of the following intellectual property rights which were material to our Group’s
business.
Trademarks
As of the Latest Practicable Date, our Company had registered the following trademarks
which we consider to be or may be material to our business:
No. Trademark
Registration
Number Class
Place of
registration Effective period
1. /H1118/H1118
 72980546 5 PRC May 21, 2024 to
May 20, 2034
2. /H1118/H1118
 65254924 5 PRC April 7, 2023 to
April 6, 2033
3. /H1118/H1118
 51025814 42 PRC August 7, 2021 to
August 6, 2031
4 /H1118/H1118/H1118A.ۊ˙
B.˙
306740569 5 Hong Kong November 28, 2024
to November 27,
2034
5 /H1118/H1118/H1118A. GENFLEET
B. GenFleet
C. Genfleet
D. genfleet
306740587 5 Hong Kong November 28, 2024
to November 27,
2034
6 /H1118/H1118/H1118
306740578 5 Hong Kong November 28, 2024
to November 27,
2034
Patents
For material patents and patent applications of our Group as of the Latest Practicable
Date, see paragraph headed “Business — Intellectual Property” for more details.
Domain Names
As of the Latest Practicable Date, we have registered the following internet domain name
which we consider to be or may be material to our business:
No. Domain Name Registered Owner Registration Date Expiry Date
1. /H1118/H1118/H1118/H1118genfleet.com Company April 6, 2017 April 6, 2027
Save as the above, as of the Latest Practicable Date, there were no other intellectual
property rights which were material to our business.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
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--- page 713 ---
FURTHER INFORMATION ABOUT OUR DIRECTORS, SUPERVISORS, SENIOR
MANAGEMENT AND SUBSTANTIAL SHAREHOLDERS
Interests and short positions of our Directors, Supervisors and chief executive of our
Company in the Shares, underlying Shares and debentures of our Company and our
associated corporations
Save as disclosed in the section headed “Substantial Shareholders” and below,
immediately following the completion of the Global Offering (assuming that the Over-
allotment Option is not exercised), so far as our Directors are aware, none of our Directors,
Supervisors and chief executive has any interests and short positions in our Shares, underlying
Shares or debentures of our Company or any of our associated corporations (within the
meaning of Part XV of the SFO) (i) which will have to be notified to us and the Stock Exchange
pursuant to Divisions 7 and 8 of Part XV of the SFO (including interests and short positions
in which they are taken or deemed to have under such provisions of the SFO); (ii) which will
be required, pursuant to section 352 of the SFO, to be entered in the register referred to therein;
or (iii) which will be required to be notified to us and the Stock Exchange pursuant to the
Model Code for Securities Transactions by Directors of Listed Issuers contained in the Listing
Rules:
Name
Capacity/Nature
of interest
Number of
Shares (1)
Approximate
percentage of
shareholding in
the Unlisted
Shares/H Shares
immediately after
completion of the
Global Offering (2)
Approximate
percentage of
shareholding
in the total
Share capital
immediately after
completion of the
Global Offering (2)
Dr. Lu /H1118/H1118/H1118/H1118/H1118Interest in controlled
corporations
13,836,070 (3)
H Shares (L)
4.42% 4.01%
53,724,650 (4)
H Shares (L)
17.16% 15.56%
Dr. Lan /H1118/H1118/H1118/H1118/H1118Interest in controlled
corporations
53,724,650 (4)
H Shares (L)
17.16% 15.56%
Notes:
1. The letter “L” denotes the person’s long position in the Shares.
2. The calculation is based on the total number of 32,337,610 Unlisted Shares and 313,003,020 H Shares
in issue immediately after completion of the Global Offering since 235,403,020 Unlisted Shares will be
converted into H Shares and 77,600,000 H Shares will be issued pursuant to the Global Offering, taking
into account the Share Subdivision and assuming that the Offer Size Adjustment Option and the
Over-allotment Option are not exercised.
3. Shanghai Kunjin is our ESOP Platform. As of the Latest Practicable Date, Shanghai Kunjin is deemed
to be controlled by Dr. Lu as its sole general partner, and none of the limited partner of Shanghai Kunjin
held more than one-third of the partnership interest in Shanghai Kunjin. Therefore, by virtue of the SFO,
Dr. Lu is deemed to be interested in the Shares held by Shanghai Kunjin.
4. Auspicious Delight is our ESOP Platform. As at the Latest Practicable Date, GenFleet HK was held as
to 53.69% by Dr. Lu and 46.31% by Dr. Lan. GenFleet HK held 64.5% of the issued share capital of
Auspicious Delight. Therefore, by virtue of the SFO, each of Dr. Lu and Dr. Lan is deemed to be
interested in the Shares held by GenFleet HK and Auspicious Delight.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-6 –


--- page 714 ---
Interests in associated corporations
Our Directors, Supervisors and chief executive are not interested in the Shares of any
associated corporation of our Company.
Interests of the substantial shareholders in the Shares
Save as disclosed in “Substantial Shareholders,” immediately following the completion of
the Global Offering and without taking into account any Shares which may be issued pursuant
to the exercise of the Offer Size Adjustment Option and the Over-allotment Option, our
Directors are not aware of any other person (not being a Director, Supervisor or chief executive
of our Company) who will have an interest or short position in our Shares or the underlying
Shares which would fall to be disclosed to us and the Stock Exchange under the provisions of
Divisions 2 and 3 of Part XV of the SFO, or who is, directly or indirectly, interested in 10%
or more of the issued voting shares of our Company.
Interests of the substantial shareholders in other members of our Group
Our Directors are not aware of any persons (other than our Directors, Supervisors or chief
executive) who will, immediately following the completion of the Global offering, directly or
indirectly, be interested in 10% or more of the nominal value of any class of share capital
carrying rights to vote in all circumstances at general meetings of any other member of our
Group.
Particulars of Directors’ and Supervisors’ Service Contracts
Each of the Directors and Supervisors has entered into a service contract or a letter of
appointment with our Company.
Save as disclosed above, we have not entered into, and do not propose to enter into any
service contracts with any of our Directors or Supervisors in their respective capacities as
Directors or Supervisors (excluding agreements expiring or determinable by any member of
our Group within one year without payment of compensation other than statutory
compensation).
Remuneration of Directors and Supervisors
Save as disclosed in “Directors, Supervisors and Senior Management” and Notes 10 and
11 to the Accountants’ Report set out in Appendix I for the two financial years ended December
31, 2023 and 2024 and the four months ended April 30, 2025, none of our Directors or
Supervisors received other remunerations of benefits in kind from us.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-7 –


--- page 715 ---
Disclaimers
Save as disclosed in this Prospectus:
(a) none of our Directors, Supervisors or our chief executive has any interest or short
position in our Shares, underlying Shares or debentures of our Company or any of
our associated corporations (within the meaning of Part XV of the SFO) which will
have to be notified to us and the Stock Exchange pursuant to Divisions 7 and 8 of
Part XV of the SFO, or which will be required, pursuant to section 352 of the SFO,
to be entered in the register referred to therein, or which will be required to be
notified to us and the Stock Exchange pursuant to Model Code for Securities
Transactions by Directors of Listed Issuers once the H Shares are listed on the Stock
Exchange;
(b) none of our Directors or Supervisors is aware of any person (not being a Director,
Supervisor or chief executive of our Company) who will, immediately following the
completion of the Global Offering and the conversion of Unlisted Shares into
H Shares (without taking into account any H Shares which may be allotted and
issued pursuant to the exercise of the Offer Size Adjustment Option and the
Over-allotment Option), have an interest or short position in our Shares or
underlying Shares which would fall to be disclosed to us under the provisions of
Divisions 2 and 3 of Part XV of the SFO or who is interested, directly or indirectly,
in 10% or more of the issued voting shares of any member of our Group; and
(c) none of our Directors, Supervisors or any of the parties listed in “Qualifications of
Experts” in this Appendix is:
i. interested in our promotion, or in any assets which have been, within two years
immediately preceding the date of this Prospectus, acquired or disposed of by
or leased to us, or are proposed to be acquired or disposed of by or leased to
any member of our Group; or
ii. materially interested in any contract or arrangement subsisting at the date of
this Prospectus which is significant in relation to our business.
PRE-IPO EQUITY INCENTIVE SCHEME
We adopted the Pre-IPO Equity Incentive Scheme in 2020 as amended and restated in July
2023 and established the ESOP Platforms. All awards granted under the Pre-IPO Equity
Incentive Scheme had been vested and exercised and no further awards will be granted under
the Pre-IPO Equity Incentive Scheme upon Listing. The terms of the Pre-IPO Equity Incentive
Scheme are not subject to the provisions of Chapter 17 of the Listing Rules as the Pre-IPO
Equity Incentive Scheme do not involve the grant of new awards by our Company to subscribe
for H Shares after the Listing. The Pre-IPO Equity Incentive Scheme will not cause any
dilution of the shareholding of our Shareholders after the Listing given all underlying Shares
of the awards granted under the Pre-IPO Equity Incentive Scheme have been issued to the
relevant ESOP Platforms. For details of the ESOP Platforms, see “History, Development and
Corporate Structure — Our ESOP Platforms.”
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-8 –


--- page 716 ---
The following is a summary of the principal terms of the Pre-IPO Equity Incentive
Scheme:
(a) Objectives
The objectives of the Pre-IPO Equity Incentive Scheme are to build incentive mechanisms
for employees, to attract and retain outstanding talents, and to enhance the Company’s market
competitiveness and sustainable development capabilities.
(b) Eligibility
Participants of the Pre-IPO Equity Incentive Scheme include directors, supervisors,
senior management and core employees of the Group. Core employees include key business,
technical and management personnel who hold positions in the Group and have a significant
impact on the Group’s overall performance and sustainable development.
(c) Grant of Awards
Each Participant will be granted restricted shares in the form of economic interest in the
relevant ESOP Platforms either as a limited partner or shareholder (the “Awards”). Upon
becoming the limited partner or shareholder of the relevant ESOP Platforms, the Participant
indirectly receives economic interest in the number of Shares underlying the Awards granted
to the Participant held by the relevant ESOP Platforms.
(d) Payment of the Price of the Awards
The Participants must subscribe for the Awards with personal funds or self-financed
funds, and should ensure that their source of funds is lawful. The subscription period of the
Awards shall be determined by the Administrator. The Participants shall make the
corresponding payment for Awards fully and timely.
(e) Administration
The Board highest authority in respect of the implementation, amendment, interpretation,
termination, and execution of the Pre-IPO Equity Incentive Scheme. The Chairman and
General Manager are authorized to determine, among others, list of the grantees, number of
awards to be granted to the grantees and ESOP Platforms for the vesting of the awards. The
Chairman and his authorized person shall be responsible for the daily management and
implementation of the Pre-IPO Equity Incentive Scheme.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-9 –


--- page 717 ---
(f) Restriction on transfer
Prior to the Listing, the grantees may not transfer any or all of his or her interest in the
relevant ESOP Platforms unless specified in the scheme rules. After the Listing, in addition to
the restrictions under the Pre-IPO Equity Incentive Scheme, the transfer or sale by the grantees
shall be subject to the lock-up requirements under the relevant laws and regulations and the
stock exchange rules, or the respective agreements entered into between the Company and the
relevant grantees pursuant to the terms of the Pre-IPO Equity Incentive Scheme (if applicable).
(g) Lapse of awards
A share award shall be repurchased in the event of, among others:
(i) the employment of the grantee was dismissed by the Group for legal grounds or
violation of the Group’s internal policies;
(ii) the loss of ability to work of the grantees (except for work-relating injuries);
(iii) the grantee is held liable for criminal offence;
(iv) the grantee is directly responsible for any significant losses or decline in the Group’s
operating performance as determined by the Company; or
(v) the grantee committed material violation of the Group’s internal rules and
regulations.
(h) Rights of the grantees
Grantees shall be entitled to register their interests underlying the awards granted as a
limited partner or shareholder of the relevant ESOP Platforms in accordance with the Pre-IPO
Equity Incentive Scheme. The grantees shall have the rights to any dividends or distributions
as a limited partner or shareholder of the relevant ESOP Platforms based on the partnership
agreement, shareholders agreement or articles of the relevant ESOP Platforms.
(i) Duration
The Pre-IPO Equity Incentive Scheme shall be valid and effective commencing on the
effective date until the ESOP Platforms no longer hold any Shares, and in any event shall not
be longer than the period of ten (10) years.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-10 –


--- page 718 ---
OTHER INFORMATION
Estate Duty
Our Directors have been advised that no material liability for estate duty is likely to fall
on our Company or any of our subsidiaries under the laws of the PRC.
Litigation
As of the Latest Practicable Date, we were not engaged in any litigation, arbitration or
claim of material importance and no litigation, arbitration or claim of material importance was
known to our Directors to be pending or threatened by or against any member of our Group,
that would have a material and adverse effect on our Group’s results of operations or financial
conditions, taken as a whole.
Preliminary Expenses
As of the Latest Practicable Date, our Company has not incurred any material preliminary
expenses.
Promoter
The promoters of the Company are all of the 49 then Shareholders immediately before our
conversion into a joint stock limited liability company. Within the two years immediately
preceding the date of this Prospectus, no cash, securities or other benefit has been paid, allotted
or given or is proposed to be paid, allotted or given to the promoters in connection with the
Global Offering and the related transactions described in this Prospectus.
Taxation of Holders of H Shares
The sale, purchase and transfer of H Shares registered with our Hong Kong branch
register of members will be subject to Hong Kong stamp duty. The current rate charged on each
of the purchaser and seller is 0.1% of the consideration of or, if higher, of the fair value of our
Shares being sold or transferred.
No Material Adverse Change
Our Directors confirm that there has been no material adverse change in the financial or
trading position or prospects of the Group since April 30, 2025 (being the date to which the
latest consolidated financial statements of our Group were prepared).
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-11 –


--- page 719 ---
Qualifications of Experts
The qualifications of the experts (as defined under the Listing Rules and the Companies
(Winding Up and Miscellaneous Provisions) Ordinance) who have given their opinion and/or
advice in this Prospectus are as follows:
Name Qualification
CITIC Securities (Hong Kong) Limited A licensed corporation to conduct Type 4
(advising on securities) and Type 6 (advising
on corporate finance) regulated activities
under the SFO
Jia Y uan Law Offices /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118PRC legal advisor
JunHe LLP /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118PRC intellectual property law legal advisor
Jun He Law Offices P .C. /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118U.S. intellectual property law legal advisor
2K Patentanwälte — München /H1118/H1118/H1118/H1118/H1118/H1118/H1118Legal advisor as to the laws of European
Patent Convention and the national patent
laws of EPC contracting countries
Ernst & Y oung /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Certified Public Accountants under
Professional Accountants Ordinance
(Chapter 50 of the Laws of Hong Kong) and
Registered Public Interest Entity Auditor
under Accounting and Financial Reporting
Council Ordinance (Chapter 588 of the Laws
of Hong Kong)
Frost & Sullivan (Beijing) Inc.,
Shanghai Branch Co. /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Independent industry consultant
As of the Latest Practicable Date, none of the experts named above had any shareholding
interest in our Company or any of our subsidiaries or the right (whether legally enforceable or
not) to subscribe for or to nominate persons to subscribe for securities in any member of our
Group.
Consents of Experts
Each of the experts as referred to “Qualifications of Experts” in this Appendix has given
and has not withdrawn their respective written consents to the issue of this Prospectus with the
inclusion of their reports and/or letters (as the case may be) and the references to their names
included in the form and context in which they are respective included.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-12 –


--- page 720 ---
Sole Sponsor’s Independence
The Sole Sponsor satisfies the independence criteria applicable to the sponsor set out in
Rule 3A.07 of the Listing Rules.
Pursuant to the engagement letter entered into between the Company and the Sole
Sponsor, the Sole Sponsor’s fees payable by us to the Sole Sponsor in respect of its service as
the sponsor in connection with the Listing on the Stock Exchange is US$500,000.
Binding Effect
This Prospectus shall have the effect, if an application is made in pursuance of it, of
rendering all persons concerned bound by all of the provisions (other than the penal provisions)
of sections 44A and 44B of the Companies (Winding Up and Miscellaneous Provisions)
Ordinance so far as applicable.
Bilingual Prospectus
The English and Chinese language versions of this Prospectus are being published
separately, in reliance upon the exemption provided under section 4 of the Companies
(Exemption of Companies and Prospectuses from Compliance with Provisions) Notice
(Chapter 32L of the Laws of Hong Kong).
Miscellaneous
Save as otherwise disclosed in this Prospectus:
(a) within the two years preceding the date of this Prospectus: (i) we have not issued nor
agreed to issue any share or loan capital fully or partly paid either for cash or for
a consideration other than cash; and (ii) no commissions, discounts, brokerage fee
or other special terms have been granted in connection with the issue or sale of any
shares of our Company;
(b) no share or loan capital of our Company is under option or is agreed conditionally
or unconditionally to be put under option;
(c) we have not issued nor agreed to issue any founder shares, management shares or
deferred shares;
(d) there are no arrangements under which future dividends are waived or agreed to be
waived;
(e) there are no procedures for the exercise of any right of pre-emption or transferability
of subscription rights;
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-13 –


--- page 721 ---
(f) there are no contracts for hire or hire purchase of plant to or by us for a period of
over one year which are substantial in relation to our business;
(g) there have been no interruptions in our business which may have or have had a
significant effect on our financial position in the last 12 months;
(h) there are no restrictions affecting the remittance of profits or repatriation of capital
by us into Hong Kong from outside Hong Kong;
(i) no part of the equity or debt securities of our Company, if any, is currently listed on
or dealt in on any stock exchange or trading system, and no such listing or
permission to list on any stock exchange other than the Hong Kong Stock Exchange
is currently being or agreed to be sought;
(j) our Company has no outstanding convertible debt securities or debentures;
(k) our Company is a joint stock limited company and is subject to the PRC Company
Law; and
(l) our Company has adopted a code of conduct regarding Directors’ and Supervisors’
securities transactions on terms as required under the Model Code for Securities
Transactions by Directors of Listed Issuers as set out in Appendix C3 to the Hong
Kong Listing Rules.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-14 –


--- page 722 ---
DOCUMENTS DELIVERED TO THE REGISTRAR OF COMPANIES IN HONG KONG
The documents attached to a copy of this Prospectus delivered to the Registrar of
Companies in Hong Kong for registration were:
(a) copies of the material contracts referred to in “Statutory and General Information —
Further Information about our Business — Summary of Material Contracts” in
Appendix IV; and
(b) the written consents referred to in “Statutory and General Information — Other
Information — Consents of Experts” in Appendix IV .
DOCUMENTS A V AILABLE ON DISPLAY
Copies of the following documents will be published on the Stock Exchange’s website at
www.hkexnews.hk and the Company’s website at www.genfleet.com during a period of 14
days from the date of this Prospectus:
(a) the Articles of Association;
(b) the audited consolidated financial statements of our Group for the two years ended
December 31, 2023 and 2024 and the four months ended April 30, 2025;
(c) the Accountants’ Report from Ernst & Y oung, the text of which is set out in
Appendix I;
(d) the report from Ernst & Y oung on the unaudited pro forma financial information of
our Group, the text of which is set out in Appendix II;
(e) the material contracts referred to in “Statutory and General Information — Further
Information about our Business — Summary of Material Contracts” in Appendix IV;
(f) the written consents referred to in “Statutory and General Information — Other
Information — Consents of Experts” in Appendix IV;
(g) the service contracts and letters of appointment referred to in “Statutory and General
Information — Further Information about our Directors, Supervisors, Senior
Management and Substantial Shareholders — Particulars of Directors’ and
Supervisors’ Service Contracts” in Appendix IV;
(h) the legal opinions issued by Jia Y uan Law Offices, our PRC Legal Advisor, in
respect of, among other things, the general corporate matters of our Group under the
PRC law;
APPENDIX V DOCUMENTS DELIVERED TO THE REGISTRAR OF
COMPANIES IN HONG KONG AND A V AILABLE ON DISPLAY
– V-1 –


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(i) the legal opinion issued by 2K Patentanwälte — München, our IP counsel as to the
laws of European Patent Convention and the national patent laws of EPC contracting
countries;
(j) the legal opinions issued by JunHe LLP and Jun He Law Offices P .C., our IP
counsels as to the PRC and U.S. intellectual property laws, respectively;
(k) the industry report issued by Frost & Sullivan (Beijing) Inc., Shanghai Branch Co.
referred to in “Industry Overview”; and
(l) a copy of the following PRC laws, together with unofficial English translations:
(i) the PRC Company Law;
(ii) the PRC Securities Law; and
(iii) the Overseas Listing Trial Measures.
APPENDIX V DOCUMENTS DELIVERED TO THE REGISTRAR OF
COMPANIES IN HONG KONG AND A V AILABLE ON DISPLAY
– V-2 –


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勁方醫藥科技 ( 上海 ) 股份有限公司
GenFleet Therapeutics (Shanghai) Inc.
