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IMPORTANT: If you are in any doubt about any of the contents of this prospectus, you should obtain independent professional advice.
Duality Biotherapeutics, Inc.
ي
Incorporated under the laws of the Cayman Islands with limited liability)
GLOBAL OFFERING
Number of Offer Shares under the
Global Offering
: 15,071,600 Shares (subject to the Offer
Size Adjustment Option and the Over-
allotment Option)
Number of Hong Kong Offer Shares : 1,507,200 Shares (subject to reallocation)
Number of International Offer Shares : 13,564,400 Shares (subject to
reallocation, the Offer Size Adjustment
Option and the Over-allotment
Option)
Maximum Offer Price : HK$103.20 per Offer Share, plus
brokerage of 1.0%, SFC transaction
levy of 0.0027%, Stock Exchange
trading fee of 0.00565%, and AFRC
transaction levy of 0.00015% (payable
in full on application in Hong Kong
dollars and subject to refund)
Nominal Value : US$0.0001 per Share
Stock Code : 9606
Joint Sponsors
Morgan Stanley Jefferies CITIC Securities
(no particular order)
Overall Coordinators, Joint Global Coordinators, Joint Bookrunners and
Joint Lead Managers
Morgan Stanley Jefferies CLSA Limited CICC CMBI
(no particular order)
Joint Bookrunners and Joint Lead Managers
ICBCI BOCI GFSHK ABCI
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 howsoever arising from or in relia nce upon the whole or any part of the contents of this prospectus.
A copy of this prospectus, having attached thereto the documents specified in “Appendix V — Documents Delivered to the Registrar of Companies and Avai lable on Display” 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 3 2 of the Laws of Hong Kong). The Securities and
Futures Commission of Hong Kong and the Registrar of Companies in Hong Kong take no responsibility as to the contents of this prospectus or any other doc ument referred to above.
The Offer Price is expected to be determined by agreement between the Joint Representatives (for themselves and on behalf of the Underwriters) and us o n the Price Determination Date. The Price Determination
Date is expected to be on or about Friday, April 11, 2025 and, in any event, not later than 12:00 noon on Friday, April 11, 2025. The Offer Price will be not m ore than HK$103.20 and is currently expected to
be not less than HK$94.60. Applicants for Hong Kong Offer Shares are required to pay, on application, the maximum Offer Price of HK$103.20 for each Hong Kong Offer Share together with brokerage of 1.0%,
SFC transaction levy of 0.0027%, Stock Exchange trading fee of 0.00565% and AFRC transaction levy of 0.00015%, subject to refund if the Offer Price sho uld be lower than HK$103.20. If, for any reason,
the Joint Representatives (for themselves and on behalf of the Underwriters) and us are unable to reach an agreement on the Offer Price by 12:00 noon on F riday, April 11, 2025, the Global Offering will not
proceed and will lapse.
The Joint Representatives (for themselves and on behalf of the Underwriters) may, with our consent, reduce the number of Offer Shares being offered un der the Global Offering and/or the indicative
Offer Price range 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 P ublic Offering. In such case, an announcement
will be published on the websites of the Stock Exchange at www.hkexnews.hk and the Company at www.dualitybiologics.com and the offer will be canceled and relaunched at the revised number of
Offer Shares and/or the revised Offer Price range and the requirements under Rule 11.13 of the Listing Rules (which include the issue of a supplemental or a new prospectus (as appropriate)), as soon
as practicable following the decision to make such reduction, and in any event not later than the morning of the day which is the last day for lodging appl ications under the Hong Kong Public Offering.
For more details, see the sections headed “Structure of the Global Offering” and “How to Apply for Hong Kong Offer Shares” 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 but not limited to the risk factors set out in the section headed
“Risk Factors” in this prospectus.
The obligations of the Hong Kong Underwriters under the Hong Kong Underwriting Agreement to subscribe for, and to procure applicants for the subscrip tion for, the Hong Kong Offer Shares, are
subject to termination by the Joint Representatives (for themselves and on behalf of the Hong Kong Underwriters) if certain grounds arise prior to 8:0 0 a.m. on the Listing Date. Such grounds are
set out in the section headed “Underwriting — Underwriting Arrangements and Expenses — Hong Kong Public Offering — Grounds for Termination” in this pr ospectus.
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 not be offe red, sold, pledged or transferred within the United
States, except in transactions exempt from, or not subject to, the registration requirements of the U.S. Securities Act. The Offer Shares are being of fered and sold (1) solely to QIBs as defined in Rule 144A
pursuant to an exemption from registration under the U.S. Securities Act, and (2) outside the United States in offshore transactions in reliance on Re gulation S under the U.S. Securities Act.
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 websites of the Stock Exchange ( www.hkexnews.hk ) and our Company ( www.dualitybiologics.com ). If you require a printed copy of this prospectus, you may download
and print from the website addresses above.
IMPORTANT
April 7, 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 document to the public in relation to
the Hong Kong Public Offering.
This document 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.dualitybiologics.com. If you require a printed copy of this
document, you may download and print from the website addresses above.
To apply for the Hong Kong Offer Shares, you may:
(a) apply online through the White Form eIPO service through the designated website
at http://www.eipo.com.hk ;
(b) 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.
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 document 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
(Chapter 32 of the laws of Hong Kong).
If you are an intermediary , broker or agent , please remind your customers, clients or
principals, as applicable, that this document is available online at the website addresses
above.
Please refer to the section headed “How to Apply for Hong Kong Offer Shares” in this
document for further details of 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 by giving electronic
application instructions to HKSCC must be for a minimum of 100 Hong Kong Offer Shares
and in one of the numbers set out in the table.
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, you are required to pre-fund your
application based on the amount specified by your broker or custodian , as determined based
on the applicable laws and regulations in Hong Kong.
Duality Biotherapeutics, Inc. (Stock Code 9606)
(HK$103.20 per Hong Kong Offer Share)
NUMBER OF HONG KONG OFFER SHARES THAT MAY BE APPLIED
FOR AND PAYMENTS
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2)
on application
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2)
on application
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2)
on application
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2)
on application
HK$ HK$ HK$ HK$
100 10,424.08 2,000 208,481.54 10,000 1,042,407.72 200,000 20,848,154.40
200 20,848.16 2,500 260,601.94 20,000 2,084,815.45 250,000 26,060,193.00
300 31,272.24 3,000 312,722.31 30,000 3,127,223.15 300,000 31,272,231.60
400 41,696.30 3,500 364,842.70 40,000 4,169,630.88 350,000 36,484,270.20
500 52,120.39 4,000 416,963.09 50,000 5,212,038.60 400,000 41,696,308.80
600 62,544.46 4,500 469,083.48 60,000 6,254,446.32 450,000 46,908,347.40
700 72,968.54 5,000 521,203.85 70,000 7,296,854.05 500,000 52,120,386.00
800 83,392.61 6,000 625,444.63 80,000 8,339,261.75 600,000 62,544,463.20
900 93,816.70 7,000 729,685.40 90,000 9,381,669.48 700,000 72,968,540.40
1,000 104,240.77 8,000 833,926.18 100,000 10,424,077.20 753,600
(1) 78,555,845.78
1,500 156,361.16 9,000 938,166.95 150,000 15,636,115.80
(1) Maximum number of Hong Kong Offer Shares you may apply for and this is 50% of the Hong Kong Offer
Shares initially offered.
(2) The amount payable is inclusive of brokerage, SFC transaction levy, the Stock Exchange trading fee and
Accounting and Financial Reporting Council (“ AFRC ”) transaction levy. If your application is successful,
brokerage will be paid to the Exchange Participants (as defined in the Listing Rules) or to the Hong Kong
Share Registrar (for applications made through the application channel of the Hong Kong Share Registrar)
while the SFC transaction levy, the Stock Exchange trading fee and the AFRC transaction levy will be paid
to the SFC, the Stock Exchange and the AFRC, respectively.
No application for any other number of Hong Kong Offer Shares will be considered and
any such application is liable to be rejected.
IMPORTANT
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If there is any change in the following expected timetable of the Hong Kong Public
Offering, our Company will issue an announcement to be published on the websites of the
Stock Exchange at www.hkexnews.hk and our Company at www.dualitybiologics.com .
Date (1)
Hong Kong Public Offering commences ............................. .9:00 a.m. on
Monday, April 7, 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
Thursday, April 10, 2025
Application lists of the Hong Kong Public Offering open (3) ............... 1 1:45 a.m. on
Thursday, April 10, 2025
Latest time for (a) completing payment of White Form eIPO
applications by effecting internet banking transfer(s) or PPS
payment transfer(s) and (b) giving electronic application
instructions to HKSCC
(4) ..................................... .12:00 noon on
Thursday, April 10, 2025
If you are instructing your broker or custodian who is a HKSCC Participant submit an
EIPO application on your behalf through HKSCC’ s FINI system in accordance with your
instruction, 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 of the Hong Kong Public Offering close
(3) ............. .12:00 noon on
Thursday, April 10, 2025
Expected Price Determination Date (5) ........................ .Friday, April 11, 2025
Where applicable, announcement of the Offer Price being set
below the bottom end of the indicative Offer Price range
on the website of the Stock Exchange at www.hkexnews.hk
and the Company’s website at www.dualitybiologics.com
at or before ................................................1 1:00 p.m. on
Monday, April 14, 2025
EXPECTED TIMETABLE (1)
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(1) Announcement of the final Offer Price, the level of
indications of interest in the International Offering, the
level of applications in the Hong Kong Public Offering
and the basis of allocation of the Hong Kong Offer Shares
to be published on the websites of the Stock Exchange
at www.hkexnews.hk and our Company at
www.dualitybiologics.com at or before (7) .......................1 1:00 p.m. on
Monday, April 14, 2025
(2) Results of allocations in the Hong Kong Public Offering (with successful applicants’
identification document numbers, where applicable) to be available through a variety of
channels, including:
 in the announcement to be posted on the
websites of the Stock Exchange at
www.hkexnews.hk and our Company
at www.dualitybiologics.com , respectively .........a to r before 11:00 p.m. on
Monday, April 14, 2025
 from the designated results of allocations
website at www.iporesults.com.hk
(alternatively: www.eipo.com.hk/eIPOAllotment )
with a “search by ID” function ................ 2 4 hours, from 11:00 p.m. on
Monday, April 14, 2025
to 12:00 midnight on
Sunday, April 20, 2025
 from the allocation results telephone
enquiry line by calling +852 2862 8555
between 9:00 a.m. and 6:00 p.m. on ................T uesday, April 15, 2025,
Wednesday, April 16, 2025,
Thursday, April 17, 2025,
and Tuesday, April 22, 2025
Share certificates in respect of wholly or partially
successful applications pursuant to the Hong Kong
Public Offering to be despatched or deposited into
CCASS on or before
(8) ................................ .Monday, April 14, 2025
White Form e-Refund payment instructions/refund
checks in respect of (i) wholly or partially successful
applications (if applicable) and (ii) wholly or partially
unsuccessful applications pursuant to the Hong Kong
Public Offering to be despatched on or before
(9)(10)(11) ........T uesday, April 15, 2025
EXPECTED TIMETABLE (1)
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Dealings in the Shares on the Stock Exchange expected
to commence ............................................... a t 9:00 a.m. on
Tuesday, April 15, 2025
(1) All times and dates refer to Hong Kong local times and dates, except as otherwise stated.
(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 lodging 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 lodging applications, when the application lists close.
(3) If there is/are a “black” rainstorm warning signal, a tropical cyclone warning signal number eight or above
and/or Extreme Conditions in force in Hong Kong at any time between 9:00 a.m. and 12:00 noon on Thursday,
April 10, 2025, the application lists will not open and will close on that day. See the section headed “How to
Apply for Hong Kong Offer Shares — E. Severe Weather Arrangements” in this prospectus.
(4) Applicants who apply for the Hong Kong Offer Shares by giving electronic application instructions to
HKSCC or instructing your broker or custodian to apply on your behalf via HKSCC’s FINI system should
refer to the section headed “How to Apply for Hong Kong Offer Shares — A. Applications for Hong Kong
Offer Shares — 2. Application Channels” in this prospectus.
(5) The Price Determination Date is expected to be on or about Friday, April 11, 2025. If, for any reason, the Offer
Price is not agreed not later than 12:00 noon on Friday, April 11, 2025 the Global Offering will not proceed
and will lapse.
(6) To be announced as soon as practicable after the Price Determination Date but before the allotment result
announcement.
(7) None of the websites or any of the information contained on the websites forms part of this prospectus.
(8) Share certificates for the Hong Kong Offer Shares are expected to be issued on Monday, April 14, 2025 but
will only become valid evidence of title provided that (i) the Global Offering has become unconditional in all
respects, and neither of the Underwriting Agreements has been terminated in accordance with its terms, prior
to 8:00 a.m. on the Listing Date, which is expected to be on or around Tuesday, April 15, 2025. Investors who
trade Shares on the basis of publicly available allocation details before the receipt of share certificates or
before the share certificates becoming valid certificates of title do so entirely at their own risk, (ii) the right
of termination as described in the paragraph headed “Grounds for Termination” under the section headed
“Underwriting” in this prospectus has not been exercised and has lapsed.
(9) White Form e-Refund payment instruction 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 or passport number, or, if the application is made by joint applicants, part of the Hong
Kong identity card 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 purpose.
Banks may require verification of an applicant’s Hong Kong identity card number or passport number before
cashing the refund check. Inaccurate completion of an applicant’s Hong Kong identity card number or passport
number may lead to delay in encashment of or may invalidate the refund check. Further information is set out
in the section headed “How to Apply for Hong Kong Offer Shares” in this prospectus.
(10) Applicants who apply via HKSCC EIPO channel should refer to the section headed “How to Apply for Hong
Kong Offer Shares — D. Despatch of Share Certificates and Refund of Application Monies” in this prospectus
for details. Applicants who have applied through the White Form eIPO service by paying the application
monies through single bank accounts may have refund monies (if any) despatched to the bank account in the
form of White Form e-Refund payment instructions. Applicants who apply via the White Form eIPO service
by paying the application monies through multiple bank accounts may have refund monies (if any) despatched
to the address as specified in their application instructions in the form of refund checks by ordinary post and
at their own risk.
EXPECTED TIMETABLE (1)
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Share certificates and/or refund checks will be dispatched by ordinary post, at the applicants’ risk, to the
addresses specified in the relevant applications.
Further information is set out in the sections headed “How to Apply for Hong Kong Offer Shares —
D. Despatch of Share Certificates and Refund of Application Monies.”
(11) In case a tropical cyclone warning signal number eight or above, a black rainstorm warning signal and/or
Extreme Conditions is/are in force from Monday, April 7, 2025 to Tuesday, April 15, 2025, then the day of (i)
announcement of results of allocations in the Hong Kong Public Offering; (ii) despatch of Share certificates
and refund checks/ White Form e-Refund payment instructions; and (iii) dealings in the Shares on the Stock
Exchange may be postponed and an announcement may be made in such event.
The above expected timetable is a summary only. Y ou should refer to the sections headed
“Structure of the Global Offering” and “How to Apply for Hong Kong Offer Shares” in this
prospectus for details of the structure of the Global Offering, including the conditions of the
Global Offering, and the procedures for application for the Hong Kong Offer Shares.
If the Global Offering does not become unconditional or is terminated in accordance with
its terms, the Global Offering will not proceed. In such case, the Company will make an
announcement as soon as practicable thereafter.
You should read carefully “Underwriting,” “Structure of the Global Offering” and “How
to Apply for Hong Kong Offer Shares” for details relating to the structure of the Global
Offering, procedures on the applications for Hong Kong Offer Shares and the expected
timetable, including conditions, effect of bad weather and/or Extreme Conditions and the
despatch of refund monies and Share certificates.
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, and does not constitute, an offer or a solicitation
of an offer to subscribe for or buy, any security 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 or the distribution in any jurisdiction other than Hong Kong. The
distribution of this prospectus 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.
Y ou should rely only on the information contained in this prospectus to make your
investment decision. 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 made in this prospectus must not be relied on by you as having been
authorized by us, the Joint Sponsors, the Joint Representatives, the Overall
Coordinators, the Joint Global Coordinators, the Capital Market Intermediaries, the
Joint Bookrunners and the Joint Lead Managers, any of the Underwriters, any of our
or their respective directors, officers or representatives, or any other person or party
involved in the Global Offering.
IMPORTANT ...................................................... i i
EXPECTED TIMETABLE ........................................... i v
CONTENTS ...................................................... viii
SUMMARY ....................................................... 1
DEFINITIONS .................................................... 3 0
GLOSSARY OF TECHNICAL TERMS ................................. 4 3
FORW ARD-LOOKING STATEMENTS ................................. 5 8
RISK FACTORS ................................................... 6 0
CONTENTS
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W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES (WINDING UP AND
MISCELLANEOUS PROVISIONS) ORDINANCE ...................... 1 2 8
INFORMATION ABOUT THIS PROSPECTUS AND THE GLOBAL
OFFERING ...................................................... 1 4 3
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING ..... 1 4 8
CORPORATE INFORMATION ....................................... 1 5 8
INDUSTRY OVERVIEW ............................................. 1 6 1
REGULATORY OVERVIEW ......................................... 2 1 5
HISTORY AND CORPORATE STRUCTURE ............................ 2 5 0
BUSINESS ........................................................ 2 8 9
FINANCIAL INFORMATION ........................................ 4 3 7
SHARE CAPITAL .................................................. 4 7 7
SUBSTANTIAL SHAREHOLDERS .................................... 4 8 2
DIRECTORS AND SENIOR MANAGEMENT ........................... 4 8 4
CORNERSTONE INVESTORS ........................................ 5 0 7
FUTURE PLANS AND USE OF PROCEEDS ............................ 5 2 3
UNDERWRITING ................................................. 5 2 7
STRUCTURE OF THE GLOBAL OFFERING ........................... 5 4 0
HOW TO APPLY FOR HONG KONG OFFER SHARES ................... 5 5 3
APPENDIX I – ACCOUNTANT’S REPORT ..................... I - 1
APPENDIX II – UNAUDITED PRO FORMA
FINANCIAL INFORMATION .................. II-1
APPENDIX III – SUMMARY OF THE CONSTITUTION OF
OUR COMPANY AND CAYMAN ISLANDS
COMPANY LA W ............................ III-1
APPENDIX IV – STATUTORY AND GENERAL INFORMATION ..... I V - 1
APPENDIX V – DOCUMENTS DELIVERED TO THE REGISTRAR
OF COMPANIES 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 it is a summary, it does not contain all the information that may be
important to you and is qualified in its entirety by, and should be read in conjunction
with, the full document. Y ou should read the whole document before you decide 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 forth in the section headed
“Risk Factors” of this prospectus. Y ou 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 as we do not meet the requirements under Rules 8.05(1), (2) or (3) of the
Listing Rules. There are unique challenges, risks and uncertainties associated with
investing in companies like ours. Notably, our Core Products are in the early stages of
clinical development. We may continue to incur substantial costs and expenses in
relation to R&D activities for the Core Products and our Core Products may not be
successfully developed or marketed. Y our investment decision should be made in light
of these considerations.
OVERVIEW
Incorporated in 2019, we are a key player in the global antibody-drug conjugate (“ ADC”)
landscape, dedicated to the development of innovative therapeutics in this fast-growing drug
modality to treat cancer, autoimmune diseases, and beyond. We have self-discovered two Core
Products, namely DB-1303/BNT323, a HER2 ADC candidate targeting cancers including
endometrial cancer
1 (“EC”) and breast cancer 2 (“BC”), and DB-1311/BNT324, a B7-H3 ADC
candidate targeting cancers including small-cell lung cancer 3 (“SCLC ”), castration-resistant
prostate cancer 4 (“CRPC ”), esophageal squamous cell carcinoma 5 (“ESCC ”) and head and
neck squamous cell carcinoma (“ HNSCC ”)6. In addition to our Core Products, we have also
self-discovered (i) five other clinical-stage ADCs (namely, DB-1310, DB-1305/BNT325,
DB-1312/BG-C9074, DB-1419 and DB-2304) with potential in a broad range of indications,
each ranking among the most clinically advanced globally in terms of overall or lead indication
development progress, according to Frost & Sullivan; (ii) two bispecific ADCs (“ BsADCs ”)
(DB-1418/A VZO-1418 and DB-1421) that are expected to enter into clinical stage from 2025
to 2026; and (iii) multiple other preclinical ADCs.
WE MAY NOT BE ABLE TO SUCCESSFULLY DEVELOP, MARKET AND/OR
GENERATE MEANINGFUL ECONOMIC V ALUE FROM OUR PIPELINE PRODUCTS,
INCLUDING CORE PRODUCTS DB-1303 AND DB-1311.
Notes:
1 Cancer that develops in the lining of the uterus.
2 Cancer that develops in the tissue of the breasts.
3 A subtype of lung cancer that develops in the small cells of the lungs.
4 A subtype of prostate cancer that continues to grow despite hormone therapy.
5 A subtype of esophageal cancer that develops in the flat cells lining the food pipe.
6 Cancer that develops in the flat cells lining various areas of the head and neck, including the mouth, throat,
and voice box.
SUMMARY
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ADCs have emerged as one of the most promising and fastest-growing treatment
modalities, with the ability to leverage the targeting and binding abilities of antibodies to
precisely deliver cytotoxic payloads to cancer or other diseased cells. The following diagram
illustrates an ADC’s structure.
Main Structure of ADC
Antibody
Linker
 Cytotoxic/Payload
drugBridge between
antibody and drugs and
to control the release
of drugs inside cancer cell
Recognition of
target cancer cell
Warhead for destroying
cancer cell
Guidance system
for cytotoxic drugs
Target Antigen
We have established four globally innovative ADC technology platforms. Our
topoisomerase-based DITAC platform has demonstrated a wide therapeutic window (i.e., safe
and effective dosage range) which potentially translates into improved efficacy and safety in
the clinical setting. Topoisomerase is an enzyme that plays an essential role in DNA replication
and transcription. By targeting topoisomerase, ADCs derived from our DITAC platform can
potentially treat various solid tumors by inhibiting DNA replication and inducing DNA damage
in cancer cells. Our know-how and execution capabilities have further enabled us to design
multiple modular platforms and engineer next-generation ADC therapeutics with unique
features, including novel payloads (i.e., therapeutic agents delivered to the target area) and
bispecific formats, that can potentially generate synergistic and combination effects, which
may lead to significant improvement in patient outcomes.
All of our clinical-stage assets had obtained investigational new drug (“ IND”) approvals
from both the United States Food and Drug Administration (the “ FDA”) and the National
Medical Products Administration of the PRC (the “ NMPA”) as of the Latest Practicable Date.
We have seven ongoing global multi-regional clinical trials (“ MRCTs”) across 17 countries
and over 230 trial sites, with over 2,000 patients enrolled (more than 50% located in the U.S.,
EU, Australia and other regions outside China) as of the Latest Practicable Date, including four
conducted in collaboration with our strategic partners for which we are currently acting as the
trial sponsor. Our innovative ADC assets have attracted leading global biopharmaceutical
companies, culminating in several global partnerships to date, including with BioNTech SE
(“BioNTech ”), BeiGene, Ltd. (“ BeiGene ”), Adcendo ApS (“ Adcendo ”), GSK plc (“ GSK”),
and Avenzo Therapeutics, Inc. (“ Avenzo ”), with over US$6.0 billion in total deal value (of
which approximately US$500 million had been received as of the Latest Practicable Date).
SUMMARY
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--- page 13 ---
The pipeline chart below summarizes the development status of our clinical-stage drug candidates and selected preclinical assets, all of which
are in-house discovered.
Global
Global
Global
TROP2
OC (2L+) Mono
NCT05438329 Trial completion: 2025
Mainland China,
Hong Kong,
Macau
NSCLC (2L+) Mono
NSCLC, OC, CC, TNBC (multiple lines) +PD-L1xVEGF bsAb
Solid Tumors (CC, TNBC, etc.) Mono
Oncology
HER2
HER2-expressing EC (2L+)
Mono NCT05150691 Trial completion: 2027
Mainland China,
Hong Kong,
Macau
Mono NCT06340568 Trial completion: 2029
HR+/HER2-low BC (chemo naïve) Mono NCT06018337 Trial completion: 2028
HER2+ BC (2L+) Mono NCT06265428 Trial completion: 2026
HER2+ BC (1L) + Pertuzumab
NCT05150691 Trial completion: 2027
Solid Tumors (OC, CRC, esophageal cancer, etc.) Mono
HER3
EGFRm NSCLC (TKI-resistant) + Osimertinib
NCT05785741 Trial completion: 2026 Global
KRASm NSCLC (2L+) Mono
HER2-expressing BC (Post-Enhertu) + Trastuzumab
Solid Tumors Mono
DB-1312
/BG-C9074 B7-H4 Solid Tumors Mono/ + Tislelizumab NCT06233942 Trial completion: 2027 /
DB-1314 Undisclosed Solid Tumors Mono / IND submission: 2026 Global
DB-1317 Undisclosed Solid Tumors Mono / IND submission: 2025 Global
Autoimmune
Program Target Indications (lines of treatment) Mono/Combo Preclinical/
IND-Enabling Phase 1 Phase 2a/
Phase 2 Trial LocationPhase 3 NCT Number Upcoming Milestone Commercial Rights Partners
DITAC – Leading TOP1i ADC Platform
DB-1303
/BNT323
DB-1311
/BNT324
DB-1305
/BNT325
DB-1310
B7-H3
SCLC (2L+) Mono
NCT05914116 Trial completion: 2026
Mainland China,
Hong Kong,
Macau
(U.S.: Option to
Co-develop and
Co-commercialize)
Mono
ESCC (2L+) Mono
Solid Tumors (HNSCC, HCC, CC, melanoma, etc) Mono
CRPC (late line)
NSCLC (2L+) Mono
/
/
China
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
N.A.
N.A.
NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
**
FDA Fast
Track DesignationCore Products FDA Breakthrough
Therapy DesignationKey Products NMPA Breakthrough
Therapy Designation
FDA Orphan Drug
Designation
Note:   (1)
(2)
Abbreviations: Mono = Monotherapy, Combo = Combination Therapy, IND = Investigational New Drug, NCT = National Clinical Trial, ADC = Antibody-drug Conjugate, HER2 = Human Epidermal Growth Factor Receptor 2, HER2-expressing = HER2 Status of Tumor Cells Identified with a Test Score of IHC 1+ or Above, EC = Endometrial Cancer, HR+ = Hormone Receptor
Positive, HER2-low=HER2 Status of Tumor Cells Identified with a Test Score of IHC 1+ or IHC 2+/ISH-,  BC = Breast Cancer, Chemo = Chemotherapy, HER2+ = HER2 Status of Tumor Cells Identified with a Test Score of Either IHC 3+ or IHC 2+/ISH+, OC = Ovarian Cancer, CRC = Colorectal Cancer,  SCLC = Small Cell Lung Cancer, CRPC = Castration-resistant Prostate
Cancer, ESCC= Esophageal Squamous Cell Carcinoma, NSCLC = Non-small Cell Lung Cancer, HNSCC = Head and Neck Squamous Cell Carcinoma, HCC= Hepatocellular Carcinoma, CC = Cervical Cancer, HER3 = Human Epidermal Growth Factor Receptor 3, EGFRm = EGFR Mutant, TKI = Tyrosine Kinase Inhibitor, KRASm = Kirsten Rat Sarcoma Virus Mutant, BTC =
Biliary Tract Cancer, TROP2 = Human Trophoblast Cell-surface Antigen 2, TNBC = Triple-negative Breast Cancer, PD-L1 = PD-1 Ligand 1, VEGF = Vascular Endothelial Growth Factor, bsAb = Bispecific Antibody, EGFR = Epidermal Growth Factor Receptor, BDCA2 = Blood Dendritic Cell Antigen 2, MOA = Mechanism of Action, SLE = Systemic Lupus Erythematosus,
CLE = Cutaneous Lupus Erythematosus, FDA = U.S. Food and Drug Administration, NMPA = National Medical Products Administration of the PRC, 1L: first-line treatment, 2L+: second-line or later treatment
For each drug candidate, our clinical development typically begins with a combined phase 1/2a trial, where multiple patient groups across different tumor types or indications are enrolled to assess both safety and efficacy of the drug candidate. Based on the results from these phase 1/2 trials, we determine which indications to prioritize for advancement into later-stage clinical
development. All ongoing clinical trials are subject to regulatory oversight by both the FDA and NMPA, except for DB-1303's phase 3 trial in HER2+ BC patients, which is conducted solely in China and regulated by the NMPA.
BioNTech was the sponsor of this global trial as of the Latest Practicable Date.
BeiGene was serving as the sponsor of this trial as of the Latest Practicable Date.
*
**
Single-arm, Potential Registrational Study
N.A.
N.A.
DB-1419 B7-H3 x PD-L1 Solid Tumors Mono NCT06554795 Trial completion: 2027 Global
DB-1418
/AVZO-1418 EGFR x HER3 Solid Tumors Mono / IND submission: 2025 Greater China
DB-1421 Undisclosed Solid Tumors Mono / IND submission: 2026 Global
DB-1316 Undisclosed Solid Tumors Mono / IND submission: 2026 Global
DB-2304 BDCA2 SLE, CLE Mono NCT06625671 Trial completion: 2026 Global
/
/
/
Global
Global
N.A.
N.A.
N.A.
FDA, NMPA
FDA, NMPA
DIBAC – Leading Bispecific ADC Platform
DIMAC – Leading Immune-modulating ADC Platform
DUPAC – Unique Novel MOA Payload ADC Platform
Planned Phase 3 Confirmatory Trial *
Key Regulatory
Authorities
/N.A.DB-1324 Undisclosed Solid Tumors Mono Mainland China,
Hong Kong, Macau/
AVENZO
THERAPEUTICS
SUMMARY
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--- page 14 ---
OUR BUSINESS MODEL
Since our inception, we have focused primarily on the independent discovery and
development of ADC assets. We have assembled a highly experienced team of experts in all
facets of ADC drug development. Their accumulated experience and expertise have driven our
technology platform and pipeline development, executed with quality and operational
efficiency. With our commitment to organic in-house R&D, we have developed four
cutting-edge technology platforms and a pipeline of 12 internally discovered ADC candidates
covering a diverse range of indications, which reflects our understanding of disease biology
and unique insights into target selection.
In the rapidly iterating and highly competitive ADC market, we understand that
development speed is as crucial as asset quality in determining the ultimate success of an ADC
drug. As a biotech company founded in 2019, we have strategically focused our core
competencies on our technology platforms and the critical initial phases of drug development,
from drug discovery to proof-of-concept clinical trials. For late-stage clinical development
(such as global MRCTs) across multiple drug assets, we have taken a strategic and flexible
approach to drug development, leveraging both our internal resources and external partnerships
to rapidly bring our drugs to market. This efficient model allows us to maintain our agility and
innovation as a young biotech company while tapping into the scale and experience necessary
for successful late-stage global development.
Furthermore, we systematically assess our clinical programs to explore the full
therapeutic potential of our ADC candidates across diverse treatment approaches, including
through combination therapies and expanded patient populations. For example, our phase 1/2a
clinical trials, as the first-in-human study of our ADC candidates, include multiple ongoing
treatment cohorts that we continuously evaluate and dynamically expand or adjust. These
cohorts generate wide-ranging and foundational data that informs our regulatory discussions
with the competent authorities and shapes our late-stage clinical development strategy,
particularly for indication expansion. This comprehensive evaluation strategy enables us to
optimize therapeutic regimens, identify promising patient subgroups, accelerate development
timelines, and ultimately deliver more effective treatment options to patients in need. As of the
Latest Practicable Date, we had received no major concerns or objections from the NMPA or
FDA to the clinical development plans of our ADC candidates.
Our successful in-house R&D has drawn the attention of global biopharmaceutical
companies, and we have entered into collaborations to accelerate the global expansion of our
drug programs and maximize their impact on patients worldwide. These collaborations are
win-win for us and our partners. We have retained development and commercialization rights
to these assets in certain territories, and have continued to play a core role in the overall
development strategy and direction of these assets on a global level. The partnerships enable
us to maximize the clinical value of our in-house discovered assets and provide financial
resources to further invest in our pipeline development. Moreover, these collaborations provide
our partners with high-quality clinical-stage ADC assets to complement their drug portfolios
and support their long-term strategies.
SUMMARY
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Going forward, we expect to continue to implement this business model. We will continue
to lead the development activities of our clinical-stage assets in the regions where we retain
rights, and expect to have multiple assets entering the clinic in the next few years and more in
preclinical studies. We will also continue to optimize our ADC platforms to support further
innovation and remain open to value-accretive R&D partnerships that support our growth.
Anticipating commercialization of our late-stage ADCs, we are proactively developing a
tailored commercial strategy for each asset, harnessing both our in-house capabilities and
external collaboration.
OUR PIPELINE
We have built a pipeline of 12 in-house discovered ADC candidates, comprising: (i) seven
clinical-stage ADCs with potential in a broad range of indications; (ii) two next-generation
BsADCs that are expected to enter into clinical stage from 2025 to 2026; and (iii) multiple
other preclinical ADCs. Three of our clinical-stage assets, including our Core Products
DB-1303 and DB-1311 and key product DB-1305, have received Fast Track Designation from
the FDA, and DB-1303 has received Breakthrough Therapy Designations from both the FDA
and NMPA, for certain indications.
Core Products
 DB-1303/BNT323 is a late clinical-stage HER2 ADC candidate with two ongoing
registrational trials (one global trial and one in China) and one potential global
registrational study, with the first indication (HER2-expressing EC) projected to file
for accelerated approval with the FDA as early as 2025. DB-1303 is designed with
a stable, cleavable linker (i.e., molecule that connects the payload to the antibody of
an ADC to deliver the therapeutic agent to target cells) and proprietary
topoisomerase-based payload that aim to lower off-target toxicity and enhance
anti-tumor activity, including bystander killing effects. These features may enable
DB-1303 to potentially serve as a new therapeutic option for patients with
HER2-expressing advanced solid tumors, including both patients with high and low
expression levels of HER2. The global HER2 ADC market is expected to increase
from US$4.8 billion in 2023 to US$18.5 billion by 2028, representing a CAGR of
30.8%, according to Frost & Sullivan.
DB-1303 is being investigated as (i) a potential second-line (or later) treatment for
HER2-expressing EC patients, (ii) a potential treatment for chemo naïve HER2-low
BC patients, and (iii) a potential second-line (or later) treatment for HER2+ BC,
with combination potential to expand into earlier treatment lines. The global
incidence of endometrial cancer was 401.7 thousand cases in 2023. The global
incidence of HER2-expressing EC patients requiring first-line treatment, which
represents a subset of endometrial cancer, increased from 60.1 thousand cases in
2018 to 70.1 thousand cases in 2023 and are projected to reach 84.5 thousand cases
in 2032. The global incidence of HER2-expressing EC patients requiring second-
line (or later) treatment, which represents a subset of endometrial cancer, increased
SUMMARY
–5–


--- page 16 ---
from 44.5 thousand cases in 2018 to 52.1 thousand cases in 2023 and are projected
to reach 63.2 thousand cases in 2032. The global incidence of breast cancer was
2,408.0 thousand cases in 2023. The global incidence of chemo naïve HER2-low BC
patients, which represents a subset of breast cancer, increased from 241.9 thousand
cases in 2018 to 293.9 thousand cases in 2023 and are projected to reach 437.1
thousand cases in 2032. The global incidence of HER2+ BC patients requiring
first-line treatment, which represents a subset of breast cancer, increased from 172.8
thousand cases in 2018 to 200.4 thousand cases in 2023 and are projected to reach
264.8 thousand cases in 2032. The global incidence of HER2+ BC patients requiring
second-line (or later) treatment, which represents a subset of breast cancer,
increased from 124.4 thousand cases in 2018 to 147.3 thousand cases in 2023 and
are projected to reach 201.8 thousand cases in 2032.
As of the Latest Practicable Date, there were two HER2 ADCs approved both in the
U.S. and in China, namely Enhertu
® and Kadcyla ®, and one additional approved in
China, Aidixi ®. As of the same date, there were three HER2 ADCs (including
Enhertu ®) in phase 3 clinical development or beyond under global MRCTs. Among
these HER2 ADC candidates, DB-1303 is the most clinically advanced HER2 ADC
candidate globally that targets EC across HER2-expression levels and a candidate in
advanced clinical development for HER2 low-expressing BC, according to Frost &
Sullivan, with potential for extension to other underserved cancer indications.
DB-1303 has obtained Fast Track and Breakthrough Therapy Designations from the
FDA and Breakthrough Therapy Designation from the NMPA for the treatment of
advanced EC in patients who progressed on or after treatment with immune
checkpoint inhibitors, demonstrating DB-1303’s potential to treat advanced EC
patients who currently have low survival rates and a strong medical need for new
and more effective treatments. Moreover, DB-1303’s antitumor activity has been
observed in a range of tumors, including BC, EC, ovarian cancer (“ OC”), colorectal
cancer (“ CRC”) and esophageal cancer, supported by global clinical data from
patients across the U.S., China and Australia to date. To further advance DB-1303,
we formed a global strategic partnership with BioNTech in 2023 to accelerate its
development and maximize its global value.
SUMMARY
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The following table sets forth a summary of DB-1303’s clinical trial data to date.
Efficacy results Safety results
DB-1303
Potential Registrational Study for
HER2 Expressing EC /H1118/H1118/H1118/H1118/H1118/H1118
Based on the preliminary results from the
dose escalation and expansion studies, DB-
1303 demonstrated promising antitumor
activity with high disease control in patients
with advanced/metastatic EC, including
serous and carcinosarcomas.
 As of May 8, 2023, 17 patients were
evaluable for response. Ten patients
(58.8%) had objective partial tumor
response per RECIST v1.1. The
ORRs for patients at 7 and 8 mg/kg
dose were 50.0% (2/4) and 61.5%
(8/13), respectively. The overall DCR
was 94.1%.
Based on the preliminary results from the
dose escalation and expansion studies, DB-
1303 showed a manageable safety profile. As
of May 8, 2023, no TEAEs leading to death
or dose discontinuation occurred. No adverse
event of special interest (“AESI”) occurred,
and no DLT was observed in dose escalation.
Phase 1/2a Global Clinical Trial
for Advanced/Metastatic Solid
Tumors /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Based on the preliminary results from the
phase 1 dose escalation study, promising
antitumor activity was observed in heavily
pretreated patients with HER2-expressing
solid tumors.
 The unconfirmed ORR
1 (“uORR ”)
was 44.2% (23/52) and DCR was
88.5% (46/52).
 Encouraging anti-tumor activity of
DB-1303 was observed in advanced
BC patients, including 26 with
HER2+ BC and 13 with HER2-low
BC.
 Antitumor activity of DB-1303 was
also observed in non-BC tumor
types, including CRC, EC, OC and
esophageal cancer.
Based on the preliminary results from the
phase 1 dose escalation study, DB-1303 was
well tolerated and all AEs were manageable.
As of January 13, 2023, no DLT was
observed in all six dose levels during dose
escalation and no TEAEs associated with
death occurred.
For details, see “Business — Our Pipeline — ADC Assets Developed from
DITAC Technology Platform — DB-1303/BNT323, a late clinical stage HER2 ADC
candidate, our Core Product — Summary of Clinical Trial Data.”
1 Unconfirmed overall response rate, which is a metric used to measure the proportion of patients who achieve
a complete or partial response to a treatment, but the response has not yet been confirmed by follow-up
assessments. It is often used in early stages of clinical trials to assess preliminary effectiveness. When
presenting preliminary efficacy data with a specific cut-off date where confirmatory scans are still pending,
it is both scientifically necessary and ethically responsible to appropriately label such responses as
“unconfirmed.” This classification adheres to established RECIST criteria protocols and represents industry
best practice for transparent communication of emerging clinical data. Regulatory authorities routinely
evaluate unconfirmed response data, recognizing its value in preliminary assessment.
SUMMARY
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--- page 18 ---
 DB-1311/BNT324 is a clinically advanced B7-H3 ADC candidate under global
development. B7-H3 is a prominent member of the B7 family that plays a critical
role in promoting tumor progression and metastasis. DB-1311 is designed to harness
the potential of B7-H3 as a therapeutic target, leveraging its widespread
overexpression in a broad range of tumor types, including SCLC, non-small cell
lung cancer ( “NSCLC ”), BC, CRPC, ESCC and head and neck squamous cell
carcinoma (“ HNSCC ”). Notably, DB-1311 demonstrates strong selectivity by
targeting a specific isoform predominantly found on B7-H3-overexpressing tumor
cells, which, combined with its potent payload, stable linker-payload and fragment
crystallizable region silenced (“ Fc-silenced ”) monoclonal antibody (“ mAb”),
potentially translates into a favorable safety profile and a wide therapeutic window.
DB-1311 is being investigated as a potential second-line (or later) treatment for
mCRPC patients and SCLC patients, with combination potential to expand into
earlier treatment lines. For example, DB-1311 is currently undergoing a phase 1b/2
trial in combination with BNT327, a bsAb targeting PD-L1 and VEGF, in patients
with advanced lung cancer, including SCLC and NSCLC. The global incidence of
prostate cancer was 1,551.5 thousand cases in 2023. The global incidence of
mCRPC patients requiring first-line treatment, which represents a subset of prostate
cancer, increased from 162.3 thousand cases in 2018 to 189.6 thousand cases in
2023, and is projected to reach 232.1 thousand cases in 2032. The global incidence
of mCRPC patients requiring second-line (or later) treatment, which represents a
subset of prostate cancer, increased from 108.7 thousand cases in 2018 to 127.5
thousand cases in 2023, and is projected to reach 157.1 thousand cases in 2032. The
global incidence of lung cancer was 2,552.2 thousand cases in 2023. The global
incidence of SCLC patients requiring first-line treatment, which represents a subset
of lung cancer, increased from 243.6 thousand cases in 2018 to 284.9 thousand cases
in 2023, and is projected to reach 368.2 thousand cases in 2032. The global
incidence of SCLC patients requiring second-line (or later) treatment, which
represents a subset of lung cancer, increased from 127.1 thousand cases in 2018 to
149.4 thousand cases in 2023, and is projected to reach 194.8 thousand cases in
2032.
As of the Latest Practicable Date, there were no approved B7-H3-targeted therapies,
including ADCs, globally or in China, and there were six B7-H3 ADCs under global
MRCTs, with DB-1311 being a candidate in advanced clinical development. In
collaboration with BioNTech, we are actively pursuing a comprehensive clinical
development plan to unlock the full potential of DB-1311, both as monotherapy and
in combination with immunotherapy. DB-1311 has shown encouraging antitumor
activity and a manageable safety profile in its ongoing phase 1/2a trial, including in
patients with advanced SCLC, CRPC and multiple other solid tumors. Besides
SCLC and CRPC, we are also investigating DB-1311’s treatment potential in
HNSCC, HCC, CC, and melanoma. In 2024, the FDA granted DB-1311 Fast Track
Designation for the treatment of patients with advanced/unresectable, or metastatic
CRPC and Orphan Drug Designations for the treatment of ESCC and SCLC.
SUMMARY
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--- page 19 ---
The following table sets forth a summary of DB-1311’s clinical trial data to date.
Efficacy results Safety results
DB-1311
Phase 1/2a Clinical Trial in
Patients with
Advanced/Metastatic Solid
Tumors /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Based on the preliminary results from the
phase 1 dose escalation study, which were
presented in an oral session at the 2024
European Society of Medical Oncology Asia
Annual Meeting (“ ESMO Asia ”), DB-1311
showed encouraging antitumor activity in
advanced solid tumors.
As of September 27, 2024, the data cut-off
date for 2024 ESMO Asia, among all
evaluable patients with at least one post-
baseline tumor assessment (n=238), the
overall uORR was 32.4%, and the DCR was
82.4%.
As of the same date, among patients with
SCLC (n=73), the uORR was 56.2%, and the
DCR was 89.0%. Among patients with CRPC
(n=32), DB-1311 demonstrated early
antitumor activity with a uORR of 28.0% and
a DCR of 92.0%; radiographic progression-
free survival (“ rPFS ”) data were not yet
mature, with a median rPFS of 7.2 months
and a 6-month rPFS rate of 94.7%.
Based on the preliminary results from the
phase 1 dose escalation study, DB-1311
showed an acceptable and manageable safety
profile, with low rates of TRAEs associated
with drug discontinuation, dose reduction,
drug interruption or death.
For details, see “Business — Our Pipeline — ADC Assets Developed from
DITAC Technology Platform — DB-1311/BNT324, a B7-H3 ADC candidate with
global market potential, our Core Product — Summary of Clinical Trial Data.”
Key Products
 DB-1310 is one of the world’s most clinically advanced HER3 ADC candidates,
according to Frost & Sullivan, for which we hold global rights. HER3, along with
EGFR and HER2, are growth factor receptors in the HER family that play crucial
roles in tumor survival and growth. Despite the growing research and clinical
interest in HER3, it remains under-explored and has faced two decades of drug
development challenges due to the complexity in achieving signaling inhibition and
the potential for escape pathway activation. Guided by our team of leading experts
in HER3 research, we have built a deep knowledge base in HER3 biology, including
its dimerization patterns (i.e., the way in which two molecules combine to form a
complex structure) and intricate interactions with EGFR and HER2, and its
involvement in resistance mechanisms. These insights have informed DB-1310’s
SUMMARY
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--- page 20 ---
innovative design and equipped it with a high internalization capability (i.e., the
ability to be absorbed by target cells) to deliver payloads directly into HER3-
expressing cancer cells, which leads to targeted tumor killing and improved
therapeutic outcomes.
We believe HER3 ADCs present opportunities to cover a broad patient population
and overcome resistance to standard of care. We have developed a rational and
differentiated clinical development strategy focused on carefully selected
indications that maximize its commercial potential. Building on DB-1310’s
preliminary efficacy observed as a late-line monotherapy for EGFR-mutant
(“EGFRm ”) NSCLC, we have taken a differentiated strategy to investigate its
combination potential with osimertinib in EGFRm NSCLC patients, with
opportunity to be a first-line treatment covering a broader patient population.
DB-1310 is also one of the few global clinical-stage HER3 ADCs being investigated
as a potential treatment for KRAS-mutant (“ KRASm ”) NSCLC. We are also
exploring the efficacy signals of DB-1310 in various other solid tumors, including
BC, CRPC, HNSCC, ESCC and biliary tract cancer (“ BTC”).
 DB-1305/BNT325 is a TROP2 ADC candidate with a global development strategy.
TROP2, a validated and highly expressed ADC target across a wide spectrum of
cancers, plays a pivotal role in tumor progression. To date, there is only one TROP2
ADC approved globally, indicated for advanced triple-negative breast cancer
(“TNBC ”), urothelial cancer (“ UC”) and HR+/HER2- BC, according to Frost &
Sullivan. The global TROP2 ADC market is expected to increase from US$1.1
billion in 2023 to US$7.7 billion by 2028, representing a CAGR of 48.8%.
DB-1305 targets indications currently under-explored by other TROP2 ADC
candidates, such as OC. DB-1305 also has combination potential as a backbone
therapy in earlier lines of treatment, starting from NSCLC, OC, cervical cancer
(“CC”) and TNBC. We believe this well-rounded strategy may position DB-1305 as
a potential backbone therapy in the TROP2 ADC landscape. In collaboration with
BioNTech, we are advancing DB-1305’s global clinical development, including an
ongoing phase 1/2a global trial in patients with advanced solid tumors, where
encouraging preliminary efficacy signals in NSCLC and multiple other solid tumors
have been observed.
 DB-1419 is an innovative B7-H3xPD-L1 BsADC candidate with a DNA
topoisomerase I inhibitor, being the only B7-H3xPD-L1 BsADC currently under
clinical development globally, according to Frost & Sullivan. The simultaneous
action of delivering the toxin to tumor cell and modulate T cell activation provides
potential synergistic anti-tumor effect. Combining payload mediated cytotoxicity
with antibody mediated immunotherapy activity, DB-1419 provides an innovative
approach for cancer treatment. We have obtained IND approvals from the FDA and
the NMPA for DB-1419 and we initiated DB-1419’s phase 1/2a global trial in
September 2024.
SUMMARY
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--- page 21 ---
 DB-2304 is an innovative BDCA2 ADC candidate for systemic lupus erythematosus
(“SLE”) and cutaneous lupus erythematosus (“ CLE”), being one of the most
advanced BDCA2 ADCs in terms of development progress, according to Frost &
Sullivan. DB-2304 offers a selective therapeutic approach specifically targeting the
upstream signaling pathways of SLE/CLE pathogenesis, differentiating it from
existing lupus treatments that often have broader effects on the immune system. We
believe DB-2304 holds promise to substantially improve upon the standard of care
for SLE and CLE, such as glucocorticoids and immunosuppressants, and represents
a major step in the innovation of autoimmune ADCs. We initiated a phase 1 study
in healthy adults for DB-2304 in Australia in October 2024. We have obtained IND
approvals from the FDA and NMPA for DB-2304 and expect to complete DB-2304’s
phase 1 global trial in 2026.
OUR TECHNOLOGY PLATFORMS
Leveraging our experienced R&D team, insights into ADC design, and strong execution
capabilities, we have established four cutting-edge ADC technology platforms: DITAC,
DIBAC, DIMAC, and DUPAC, to push the boundaries of ADC treatment. Our technology
platforms serve as the foundation for continuous and sustained innovation and value creation,
whose value and versatility have been validated by our pipeline assets and recognized by global
multinational corporation (“ MNC”) partners.
1 preclinical asset 1 clinical asset
2 preclinical assets
5 clinical assets
3 preclinical assets
1 clinical asset
DITAC
Duality Immune Toxin Antibody Conjugate
DIMAC
Duality Immune Modulating Antibody Conjugate
DUPAC
Duality Unique Payload Antibody Conjugate
DIBAC
Duality Innovative Bispecific Antibody Conjugate
• Leading topoisomerase-based ADC platform
• Higher therapeutic window with enhanced toxin and linker,
bringing improved efficacy and safety
• Good tolerability profile demonstrated in over 2,000 patients
• Enhanced tumor selectivity via two tumor antigen binding
• Function synergy and pathway cross-talk
• Potential best-in-class and frontline therapy
• Potential to overcome resistance to Dxd (TOP1i)
• Targeting hard-to-treat tumor types with promising efficacy
• Potential to reshape the ADC treatment paradigm
• First-in-class ADC platform for autoimmune diseases
• “Smart steroid” targeted delivery of steroid with limited
exposure to normal tissue
• Superior to traditional antibody therapy in efficacy
Notes:
Topoisomerase: An enzyme that plays an essential role in DNA replication and transcription. By targeting
topoisomerase, ADCs derived from our DITAC platform can potentially treat various solid tumors
by inhibiting DNA replication and inducing DNA damage in cancer cells.
Payload: Therapeutic agents delivered to the target area.
Linker: Molecule that connects the payload to the antibody of an ADC to deliver the therapeutic agent to
target cells.
SUMMARY
–1 1–


--- page 22 ---
 Duality Immune Toxin Antibody Conjugate (DITAC) , our proprietary
topoisomerase inhibitor-based ADC platform, is validated by the global clinical data
from over 2,000 patients across the U.S., China, Europe, Australia and other major
markets. Compared to non-topoisomerase ADCs, topoisomerase-based ADCs have
demonstrated a wide therapeutic window which potentially translates into improved
efficacy and safety in the clinical setting. This platform is developed by screening
and optimizing a library of proprietary ADC components, including our proprietary
payloads P1003 and P1021, through meaningful technological improvements. As
such, DITAC provides critical flexibility to design our ADCs with improved
systemic stability, tumor-specific payload release, bystander-killing effects, and
rapid payload clearance.
 Duality Innovative Bispecific Antibody Conjugate (DIBAC) , one of the few
BsADC platforms in the world, is leading a new wave of ADC innovation. BsADCs
can potentially offer improved efficacy over traditional monospecific ADCs and
combination therapies, by incorporating two distinct binding moieties in a single
therapeutic entity. While promising, the complexity of BsADCs introduces new
challenges in antibody engineering, stability and manufacturing, setting a high entry
barrier. Our innovative DIBAC platform features our understanding of disease and
target biology, rich experience in bispecific antibody engineering, and artificial
intelligence-enabled target selection and antibody design.
 Duality Immune-Modulating Antibody Conjugate (DIMAC) , supported by our
proprietary immune-modulating payload, holds the potential to open the ADC
modality to a significant white-space market in autoimmune and other therapeutic
areas. DIMAC is one of the very few ADC platforms in the world that targets major
autoimmune diseases. Many patients with chronic autoimmune diseases, such as
SLE and CLE, are currently treated with therapies that often lead to severe side
effects. Long term use of glucocorticoids, for example, are commonly associated
with increased risks of bone fractures, weight gain, diabetes, immune system
suppression, and other chronic conditions. We believe ADCs can reshape the
treatment paradigm of autoimmune diseases by offering a targeted treatment with
low systemic exposure, enhanced efficacy and reduced side effects. Molecules
designed under our DIMAC platform have demonstrated potent and broad anti-
inflammatory activity, long duration of action, sustained stability, and low systemic
exposure in preclinical studies.
 Duality Unique Payload Antibody Conjugate (DUPAC) reflects our foresight into
the future landscape of ADC innovation. DUPAC is one of the few ADC platforms
globally dedicated to the development of linker-payload complexes with novel
mechanisms of action, beyond traditional cytotoxic agents, to combat growing drug
resistance and hard-to-treat tumors. We have made promising progress in a number
of unique payload mechanism and have obtained prototypes with broad-spectrum
anti-tumor activity across multiple solid tumors, and potent direct and bystander
killing effects in preclinical studies.
SUMMARY
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As of the Latest Practicable Date, we owned one patent family in relation to DITAC and
DIBAC, and one patent family in relation to DIMAC, and both patent families include multiple
patents and patent applications in different jurisdictions. For details, please see “Business —
Intellectual Property.”
OUR COMPETITIVE STRENGTHS
We believe that the following competitive strengths have differentiated us from our
competitors: (i) we are a key player in the global ADC landscape with insights and strong
execution capabilities to lead ADC innovation, (ii) we have clinically advanced ADC assets
with promising global data as validation of our leading DITAC platform, (iii) we are an
innovator in ADC development powered by versatile platforms to target underserved
therapeutic areas, (iv) we have established strategic and value-enhancing partnerships with
confidence in our platforms and pipeline to sustain long-term global development, and (v) we
are led by a world-class management team of ADC experts and seasoned entrepreneurs with a
proven track record. For details, see “Business — Our Competitive Strengths.”
OUR DEVELOPMENT STRATEGIES
Our mission is to become a global leader in the discovery, development, and
commercialization of innovative ADC therapies. Led by our founder and chief executive
officer Dr. ZHU Zhongyuan and an experienced scientific team, we have established a
dedicated global ADC development engine. Building upon these efforts, we intend to capitalize
on our competitive strengths by pursuing the following development strategies: (i) accelerating
global development and commercialization of clinical-stage assets, (ii) rapidly advance next
wave of ADC assets by leveraging accumulated global R&D and regulatory expertise, (iii)
continue technology innovation to unlock the full potential of ADCs and disrupt treatment
landscape, (iv) maximize clinical and commercial potential of our assets through value
accretive partnerships, and (v) continue to build our global presence and teams across drug
research, clinical development, regulatory affairs and commercialization. For details, see
“Business — Our Business Strategies.”
COMPETITION
The ADC industry is competitive and subject to rapid and significant change. While we
believe the strength of our pipeline, technology platforms and R&D capability gives us
competitive advantages, we face potential competition from many industry players, including
MNCs and leading biotechnology companies, who have commercialized, or are pursuing the
development of, ADC drugs that are similar to ours or target the same indications. Any ADC
candidates that we successfully develop and commercialize will compete both with approved
drugs and with any new drugs that may become available in the future. For instance, our Core
Products, DB-1303 and DB-1311, and other pipeline products may face competition from
existing ADCs directed against the same molecular targets and approved for the same target
indications upon potential marketing approval in the future. As of the Latest Practicable Date,
there were five, nine and 15 HER2 ADCs targeting EC across HER2-expressing level,
HR+/HER2-low BC, and HER2+ BC, respectively, in phase 2 clinical development or beyond
globally, including our DB-1303. As of the same date, there were nine and six B7-H3 ADCs
targeting SCLC and CRPC, respectively, under clinical development globally, including our
DB-1311.
SUMMARY
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In addition to competition within the ADC industry, our pipeline products also face
competition from other treatment modalities, including oncology chemotherapy and
monoclonal antibody for oncology treatment such as PD-(L)1 checkpoint inhibitors. Some of
these modalities may have more established market recognition and we may face challenges in
competing with them. Our competitors may have substantially greater financial, technical, and
other resources than we do, such as those with larger research and development staff and
established marketing and manufacturing infrastructure. Collaborations, mergers and
acquisitions in the biopharmaceutical industry may result in even more resources being
concentrated in our competitors. As a result, these companies may be able to advance their drug
candidates and obtain regulatory approval from the regulatory authorities more rapidly than we
do, and become more effective in selling and marketing their products. For details of the risks
relating to the competition we may face, please see “Risk Factors — Risks Relating to the
Development of Our Drug Candidates — We face intense competition and rapid technological
change and the possibility that our competitors may develop therapies that are similar, more
advanced, or more effective than ours, which may adversely affect our financial condition and
our ability to successfully commercialize our drug candidates.” For further details on market
opportunities and competition in respect of our ADC candidates, see “Business — Our
Pipeline” and “Industry Overview.”
To strengthen our long-term market position, we take a differentiated clinical
development strategy to accelerate the global expansion of our drug programs and maximize
their impact on patients worldwide. More specifically, we employ (i) a “first-to-market”
approach, where we prioritize initial target indications that are commercially attractive and
often underserved, which enable us to demonstrate key asset differentiation and potentially
obtain accelerated regulatory approval, and rapidly enter and establish a strong presence in the
global market, (ii) a complementary “fast-to-commercial” approach to accelerate access to our
differentiated assets, expanding from patients of the initial target indications to a wider
addressable population of patients in need, and (iii) combination therapy strategies to explore
the potential of our assets to enter into frontline settings and become primary treatment
options, as well as offer improved clinical benefits to patients. For details, see “Business —
Our Business Strategies — Accelerating global development and commercialization of
clinical-stage assets.”
COLLABORATION AND LICENSING ARRANGEMENTS
In line with our global strategy, we have established an array of strategic partnerships to
accelerate the development of our pipeline across key global markets, expand our global
clinical development capabilities, and fuel our future innovation and long-term growth. In our
short operating history, we have entered into several out-licensing and collaboration deals with
leading industry players worldwide to date, including BioNTech (for DB-1303, DB-1311 and
DB-1305), BeiGene (for DB-1312), Adcendo (for ADC assets using our proprietary payload
linkers), GSK (for DB-1324), and Avenzo (for DB-1418), with over US$6.0 billion in total deal
value (of which approximately US$500 million had been received as of the Latest Practicable
Date). Additionally, we have entered into in-license agreements for advanced antibody
technologies, enhancing our drug development efficiency.
SUMMARY
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--- page 25 ---
Strategic Partnership with BioNTech
BioNTech is a global leader in next-generation immunotherapy, pioneering innovative
treatments for cancer, infectious diseases, and other serious conditions. Headquartered in
Germany, BioNTech has operations across five continents and a global workforce of over 6,000
employees. In recent years, BioNTech has strategically enhanced its clinical pipeline through
global partnerships, including collaboration with our Company to add innovative ADC assets
into its oncology portfolio.
Our partnership with BioNTech, which originated from the two companies’ meetings at
industry conferences, is driven by a shared strategy to develop innovative therapies that could
potentially complement or replace chemotherapy, addressing the needs of cancer patients
across the entire disease continuum. For details on the key terms of our three licensing and
collaboration agreements with BioNTech, each relating to one of our in-house discovered ADC
assets, namely DB-1303, DB-1311 and DB-1305, see “Business — Our Collaboration and
Licensing Arrangements — License and Collaboration Agreement with BioNTech for
DB-1303/BNT323, DB-1311/BNT324 and DB-1305/BNT325.”
Collaboration with BeiGene
BeiGene is a global oncology company that is discovering and developing innovative
treatments that are more affordable and accessible to cancer patients worldwide. With a broad
portfolio, BeiGene is expediting development of its diverse pipeline of novel therapeutics
through internal capabilities and collaborations. BeiGene’s growing global team of more than
10,000 colleagues spans five continents. BeiGene is investing in impactful therapeutic
modalities such as ADCs to complement its pipeline in solid tumors.
We have entered into a strategic partnership with BeiGene, where we granted to BeiGene
a global license to develop and commercialize DB-1312, our in-house discovered B7-H4-
targeted ADC. This collaboration enables BeiGene to advance DB-1312 globally in
conjunction with its internally discovered ADC assets, leveraging our industry-leading
research capabilities and BeiGene’s end-to-end ADC manufacturing expertise and creating a
synergistic approach to drug development. For details on the key terms of our licensing and
collaboration agreement with BeiGene relating to DB-1312, see “Business — Our
Collaboration and Licensing Arrangements — Out-license and Collaboration Agreement with
BeiGene on DB-1312.”
Collaboration with Adcendo
Adcendo was founded in 2017 as a spin-out from The University of Copenhagen and
Rigshospitalet, dedicated to the development of breakthrough ADCs. Our strategic partnership
with Adcendo was established in 2022, which reflects the mutual recognition of each party’s
unique strengths in ADC discovery and development. This collaboration enables Adcendo to
utilize our proprietary DITAC platform in the advancement of their novel programs, including
uPARAP-directed ADCs. For details on the key terms of our licensing and collaboration
SUMMARY
–1 5–


--- page 26 ---
agreement with Adcendo dated December 23, 2022, see “Business — Our Collaboration and
Licensing Arrangements — Out-license and Collaboration Agreement with Adcendo on ADC
Assets Utilizing Our Proprietary Payload-linkers.”
On November 4, 2024, Adcendo entered into a new license agreement with us to develop
ADC products directed to an additional target using our proprietary DITAC platform, with
terms similar to the existing agreement with Adcendo dated December 23, 2022.
Collaboration with GSK and Avenzo
In December 2024, we entered into an exclusive option agreement with GSK for
DB-1324, a preclinical ADC asset developed with our DITAC platform. In the same month, we
entered into a collaboration and license agreement with Avenzo for DB-1418, our EGFR/HER3
BsADC. For details, see “Business — Our Collaboration and Licensing Arrangements —
Collaboration with GSK and Avenzo.”
In-licensing of Antibody Technologies for ADC Development
We have strategically in-licensed advanced antibody technologies to enhance our drug
development efficiency, while complementing our in-house capabilities in antibody research
and drug discovery. In-licensing components for innovative drug development has emerged as
a common practice, especially for complex therapeutics like ADCs, according to Frost &
Sullivan. It has enabled us to focus on our core competencies– notably our proprietary payload
technology– while leveraging external innovations to rapidly advance our ADC pipeline. For
example, in May 2022, we obtained an exclusive and sublicensable license to utilize a novel
B7-H3-targeted antibody and the underlying IP rights for the development and
commercialization of DB-1311 and other B7-H3 ADC products worldwide.
While using in-licensed antibody components, we retain independence over the
development of our novel ADC assets. Our in-licensing agreements are carefully structured to
ensure we maintain ownership and control over our ADC assets and the intellectual property
generated during drug development, including the ability to out-license the full drug candidate.
Meanwhile, the upstream licensors’ rights are generally limited to the specific antibody
components licensed to us, and do not extend to the entire ADC candidates. For further details,
see “Business — Our Collaboration and Licensing Arrangements.”
RESEARCH AND DEVELOPMENT
We conduct R&D activities primarily through our in-house R&D team. We also engage
contract research organization (“ CROs ”) from time to time to support our preclinical research
and clinical trials. In addition, we have established strategic partnerships in relation to our
pipeline assets and R&D programs, details of which are set out in “Business — Our
Collaboration and Licensing Arrangements.”
SUMMARY
–1 6–


--- page 27 ---
We have built an in-house R&D team that represent the leaders and experts of ADC
development. Our R&D team is led by Dr. QIU Y ang, our chief scientific officer, Dr. MU Hua,
our global chief medical officer, Ms. GU Wei, our chief medical officer, and Dr. HUA Haiqing,
our senior vice president and head of drug discovery, each of whom have extensive prior
experience in ADC research and a demonstrated track record contributing to the advancement
of this innovative drug modality.
Dr. Qiu drives the strategic direction of our pipeline programs, highlighted by our Core
Products and key products. She has over two decades of experience in drug discovery and
translational medicine at MNCs, including at Daiichi Sankyo where she served as co-chair of
the cross-functional ADC forum and senior director of translational medicine and was a leading
contributor to the development of innovative ADC therapy, most notably HER3-DXd
(U3-1402, patritumab deruxtecan), which received FDA Breakthrough Therapy Designation in
2021. Dr. Qiu’s understanding of the ADC landscape and track record are foundational to our
continued success as we develop cutting-edge ADC technologies that transform patient care.
Dr. Mu leads our global clinical development team and oversees our clinical development
strategies. With decades of global experience in pharmaceutical research, translational
medicine and clinical development, Dr. Mu held leadership roles at renowned MNCs,
biopharmaceutical companies and investment firms. His extensive experience as a seasoned
biotechnology executive and drug developer provides strategic vision for us to advance
efficient clinical development programs and navigate regulatory landscapes. Ms. Gu leads the
clinical development of our pipeline programs. Ms. Gu brings over ten years of expertise in
clinical development across the globe, with extensive experience leading numerous clinical
studies. Ms. Gu has built a successful track record for clinical development at renowned
MNCs, and her strategic oversight plays a key role in our efficient trial execution and
alignment with regulatory standards. Dr. Hua leads our strategies for novel drug discovery and
CMC development. Over the past 15 years, Dr. Hua has led the discovery of innovative drugs
and their advancement into the clinic at multiple MNCs. Dr. Hua’s extensive experience and
leadership in drug discovery and CMC development contribute to the seamless integration of
cutting-edge science with robust manufacturing processes, facilitating the efficient translation
of our ADC research into transformative therapies.
Supporting and executing the strategic vision of our senior management team are over
130 R&D personnel as of December 31, 2024, who had an average industry experience of over
12 years with over 80% holding a doctoral or master’ degree. As of the Latest Practicable Date,
we had over 20 core R&D team members, including scientists and experts with over 10 to 20
years of experience in diverse specialties who worked at global MNCs, such as BMS, Novartis
and Daiichi Sankyo, and leading domestic biopharma companies. In particular, each core
member of our drug discovery team has extensive and specific experience and know-how
relating to our four technology platforms, such as topoisomerase-based ADCs, autoimmune
drugs, bispecific antibodies and novel payloads, and designing and developing ADCs based on
such technologies. Their efforts, along with the expertise of our other R&D personnel,
collectively contribute to the development of pipeline programs, including our Core Products,
and the continued iteration of our technology platforms. Substantially all our core R&D team
members remained employed by us during the Track Record Period and up to the Latest
Practicable Date. Our core R&D team members are led by our seasoned senior management
SUMMARY
–1 7–


--- page 28 ---
team and strategically placed to be responsible for different aspects of drug discovery and
development, all of which contribute to the success of a drug program. In addition, employee
work products are classified as service inventions and are the property of our Company. As
such, we believe that the departure of certain core R&D personnel during the Track Record
Period did not have material impact on our business operations.
We have also built strong relationships with renowned industry experts. Regularly, we
engage our scientific advisory board of distinguished scientists to advise on our research
strategy and clinical development plan. Our scientific advisory board is led by Dr. Antoine Y ver
and Dr. Pasi A. Jänne, two leading minds in ADC drug development in the world, and Dr. Su
Ling, a distinguished expert in drug development and regulatory affairs.
In addition to our in-house R&D activities, we also collaborate with reputable CROs to
manage, conduct, and support our preclinical research and clinical trials. When selecting CRO
partners, we consider a range of factors such as their professional qualifications, relevant
research experience, service quality and efficiency, industry reputation, and pricing
competitiveness. We currently expect to continue in the engagement of our key existing CROs
and do not expect delays from them within or outside China. To the best knowledge of our
Directors, except for WuXi Biologics (Cayman) Inc., our CROs are independent of the
Company. Wuxi V enture, a wholly-owned subsidiary of WuXi Biologics (Cayman) Inc. is one
of our Shareholders.
In 2023 and 2024, our costs and expenses in relation to R&D activities, which represented
our cost of revenue and research and development expenses, were RMB986.7 million and
RMB1,993.3 million, respectively. In particular, costs and expenses in relation to R&D
activities incurred for our Core Products were RMB635.3 million and RMB1,275.3 million
during the same periods, respectively, accounting for 64.4% and 64.0% of our total costs and
expenses in relation to R&D activities for the corresponding periods. In 2023 and 2024, our
research and development expenses accounted for 89.9% and 84.1% of our total operating
expenses (which equals the sum of research and development expenses and administrative
expenses), respectively.
MANUFACTURING
To date, our manufacturing activities are conducted through contract development and
manufacturing organizations (“ CDMOs ”) to support our drug development process. We
currently outsource our manufacturing activities to industry recognized CDMOs in China. We
intend to continue this practice in the near term and at the initial stage of commercialization,
as we believe it is cost-effective and efficient to engage CDMOs for manufacturing activities
and enables us to focus on, and allocate our resources to, the discovery and clinical
development of our ADC candidates. We plan to continue to work together with our
industry-leading CDMO partners to optimize our manufacturing process, technologies, and
know-how to enhance product quality, improve cost efficiency, and shorten the time from
bench to bedside. We have maintained a relationship with the majority of our six existing
CDMOs for over three years.
SUMMARY
–1 8–


--- page 29 ---
COMMERCIALIZATION
As of the Latest Practicable Date, we had not obtained marketing approval for any drug
candidates, nor had we generated any revenue from product sales. Anticipating
commercialization of our late-stage ADCs in the next few years, we plan to maximize the value
of our drug candidates by selecting the optimal commercial model, including building our
in-house commercialization capabilities, and/or collaboration with third parties such as
distributors, contract sales organizations (“ CSOs ”), and licensing partners.
INTELLECTUAL PROPERTY
We are committed to the development and protection of our intellectual properties. Our
future success depends significantly on our ability to obtain and maintain robust patent
coverage, as well as other forms of intellectual property and proprietary protections, for the key
technologies, inventions, and know-how fundamental to our ADC pipeline and technology
platforms. We have a global portfolio of patents to protect our drug candidates and
technologies. As of the Latest Practicable Date, we owned (i) four issued patents in China, (ii)
six issued patents in the U.S., (iii) three issued patents in other jurisdictions, and (iv) 160
patent applications, including 40 in China, eight in the U.S., 19 under the Patent Cooperation
Treaty (the “ PCT”), nine in Europe, and 84 in other jurisdictions. As of the same date, with
respect to our two Core Products, DB-1303 and DB-1311, we owned four issued patents in
China and six issued patents in the U.S., two issued patents in other jurisdiction, and also
owned or in-licensed 40 patent applications, including three in China, one in the U.S., two
pending PCT patent applications, and 34 in other jurisdictions. The following table summarizes
the details of the material granted patents and patent applications in connection with our Core
Products and our technology platforms. For details, please see “Business — Intellectual
Property.”
Related product
Patent/patent
application Category
Patent/patent
application number Jurisdiction
Patent holder/
applicant
Application
date
Date of
grant
Expiration
date (1)
DB-1303 /H1118/H1118/H1118/H1118Anti-tumor Compound and
Preparation Method and
Application Thereof
(ʿՉ
ձᏐ͜)
Invention
patent
CN115925796B PRC Duality Suzhou Sept. 29,
2021
May 31,
2024
Sept. 28,
2041
DB-1303 /H1118/H1118/H1118/H1118Anti-tumor Compound and
Preparation Method and
Use Thereof
Invention
patent
US11685742B2 U.S. Duality Suzhou Sept. 29,
2021
Jun. 27,
2023
Sept. 28,
2041
DB-1311 /H1118/H1118/H1118/H1118Anti-tumor Compound and
Preparation Method and
Use Thereof
Invention
patent
US11607459B1 U.S. Duality Suzhou Sept. 29,
2021
Mar. 21,
2023
Sept. 28,
2041
SUMMARY
–1 9–


--- page 30 ---
Related product
Patent/patent
application Category
Patent/patent
application number Jurisdiction
Patent holder/
applicant
Application
date
Date of
grant
Expiration
date (1)
DB-1311 /H1118/H1118/H1118/H1118Anti-B7H3 Antibody-Drug
Conjugates and Uses
Thereof ( ҤB7H3 Ҥ᜗-ᖹ
ʿՉ͜௄)
(2)
Invention
patent
PCT/CN2023/098596 PCT Duality Suzhou Jun. 6,
2023
N/A N/A
DITAC and
DIBAC /H1118/H1118/H1118/H1118
Antitumor Compound, and
Preparation Method
Therefor and Use Thereof
(ʿՉ
ձᏐ͜)
(3)
Invention
patent
PCT/CN2021/121721 PCT Duality Suzhou Sept. 29,
2021
N/A N/A
DIMAC /H1118/H1118/H1118/H1118/H1118Steroid Compound and
Conjugate Thereof
(ʿՉၢ
ي)
3)
Invention
patent
PCT/CN2022/114855 PCT Duality Suzhou Aug. 25,
2022
N/A N/A
Notes:
(1) Patent expiration date does not include any applicable patent term extensions.
(2) PCT patent application which has the opportunity to enter national phases within specified deadline.
(3) PCT patent application which has entered national phases in various jurisdictions.
(4) We are applying for patent in relation to our DUPAC platform.
We are currently involved in three legal proceedings in China where a third party alleges
ownership rights over certain of our patent applications, which are related to parts of some
molecular structures derived from our proprietary technology platforms and used in certain of
our ADC candidates, including clinical-stage assets (such as our Core Products). For details,
see “Risk Factors — Risks Relating to Intellectual Property Rights — We may from time to
time be involved in legal proceedings and disputes to protect or enforce our intellectual
property rights, or defend against infringement and other claims alleged by third parties, which
could be expensive, time consuming and unsuccessful” and “Business — Legal Proceedings
and Compliance.”
SUPPLIERS AND PROCUREMENT
During the Track Record Period, our major suppliers primarily included (i) CROs and
CDMOs, (ii) licensing partners, and (iii) equipment and device suppliers and
renovation/construction service providers for our R&D facilities and offices. For the years
ended December 31, 2023 and 2024, our purchases from our five largest suppliers in each year
in aggregate accounted for 42.0% and 67.1% of our total purchases for the respective year,
respectively. Our purchases from our largest supplier in each year accounted for 12.5% and
25.7% of our total purchases for the respective year, respectively. To the best knowledge of our
Directors, none of our Directors, their respective associates or any of our Shareholders holding
more than 5% of our issued share capital immediately following the completion of the Global
Offering had an interest in any of our five largest suppliers during the Track Record Period. For
details, please see “Business — Suppliers and Procurement.”
SUMMARY
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--- page 31 ---
SUMMARY OF KEY FINANCIAL INFORMATION
The summary of the 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 Accountant’s Report in Appendix I to this prospectus, as
well as the information set forth in the section headed “Financial Information.”
Summary of Consolidated Statements of Profit or Loss
The following table sets forth a summary of our consolidated statements of
comprehensive loss for the periods indicated:
For the year ended December 31,
2023 2024
(RMB’000) (RMB’000)
Revenue /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,786,540 1,941,257
Cost of revenue /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(427,655) (1,156,590)
Gross profit /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,358,885 784,667
Research and development expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(558,997) (836,726)
Administrative expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(62,567) (158,692)
Other 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/H11183,261 7,338
Other gains, net /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111840,773 14,421
Operating profit/(loss) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118781,355 (188,992)
Finance 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/H111834,483 48,112
Finance costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(188) (250)
Fair value change of financial liabilities at
fair value through profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,017,899) (873,416)
Loss before income tax /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(202,249) (1,014,546)
Income tax expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(155,263) (35,888)
Loss for the year attributable to the owners of
the Company /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(357,512) (1,050,434)
During the Track Record Period, our revenue was primarily derived from our out-license
and collaboration agreements, including income in relation to upfront payments, milestone
payments, and reimbursement for R&D activities we undertake for our out-licensed candidates.
Our cost of revenue was primarily related to the R&D activities we conducted in accordance
with our out-license and collaboration agreements. Our revenue and cost of revenue increased
primarily because we entered into several out-license and collaboration agreements in 2023.
Our research and development expenses increased primarily due to an increase in staff costs
and the number and scale of our ongoing clinical trials. Our administrative expenses increased
primarily due to increase in staff costs and professional service expenses, and Listing expenses.
Our loss for the year increased from 2023 to 2024, primarily due to (i) higher research and
development expenses and administrative expenses caused by increased R&D activities and
share incentive expenses in 2024, and (ii) higher gross profit attributable to upfront payments
received pursuant to our out-license and collaboration agreements in 2023.
SUMMARY
–2 1–


--- page 32 ---
Summary of Consolidated Statements of Financial Position
The following table sets forth a summary of our consolidated statements of financial
position as of the dates indicated:
As of December 31,
2023 2024
(RMB’000) (RMB’000)
Total non-current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118166,014 180,387
Total current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,333,895 1,909,835
Total current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(2,561,246) (3,871,568)
Net current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,227,351) (1,961,733)
Total assets less current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,061,337) (1,781,346)
Total non-current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(62,576) (240,553)
Net liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,123,913) (2,021,899)
We recorded net current liabilities during the Track Record Period primarily because our
Preferred Shares issued to Pre-IPO investors are recorded as current liabilities under financial
liabilities at fair value through profit or loss. These Preferred Shares will be converted into
Ordinary Shares upon Listing, after which the amount of our financial liabilities at fair value
through profit or loss, which were recorded as our current liabilities during the Track Record
Period, will be derecognized from our liabilities and recorded as equity, which can result in the
Group turning into net current assets and net assets position. The increase in our net liabilities
during the Track Record Period was also largely due to the effect of financial liabilities at fair
value through profit or loss. See “Financial Information — Description of Selected Items from
the Consolidated Balance Sheets — Financial Liabilities at Fair V alue through Profit or Loss”
for details.
Summary of Consolidated Statements of Cash Flows
The following table sets forth the components of our consolidated statements of cash
flows for the periods indicated:
For the year ended December 31,
2023 2024
(RMB’000) (RMB’000)
Operating cash flows before movement
in working capital /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118790,947 31,559
Changes in working capital /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118239,834 260,650
Income tax paid /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(248,929) (54,540)
Interest received /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111834,483 48,112
Net cash from operating activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118816,335 285,781
Net cash (used in) investing activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(78,550) (211,151)
Net cash from/(used in) financing activities /H1118/H1118/H1118/H1118/H1118/H111810,817 (7,621)
Net increase in cash and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118748,602 67,009
Cash and cash equivalents at beginning of year /H1118/H1118/H1118375,974 1,130,889
Effect of foreign exchange rate changes /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,313 11,008
Cash and cash equivalents at the end of year /H1118/H1118/H1118/H11181,130,889 1,208,906
SUMMARY
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We recorded net cash inflow from operating activities in 2023 and 2024 primarily
attributable to payments received from our out-license and collaboration agreements. We had
cash and cash equivalents, term deposits with initial term over three months (principal
protected and available for early withdrawal at any time) and restricted cash amounting to
RMB1,435.8 million as of December 31, 2024.
We expect to fund our future operations primarily with existing cash and cash equivalents,
payments received from our out-license and collaboration agreements, and net proceeds from
the Global Offering. Upon the successful commercialization of one or more of our drug
candidates, we expect to fund our operations in part with income generated from sales of our
commercialized drug products. As our business continues to expand, we may require further
funding through equity offerings, debt financing, out-license and collaboration arrangements,
and other sources.
Our cash burn rate refers to the average monthly amount of cash used in operating
activities, payment for property, plant and equipment and payment for intangible assets,
without taking into account the cash inflow from out-licensing and collaboration agreements.
We estimate that we will receive net proceeds of approximately HK$1,308.4 million in the
Global Offering, assuming an Offer Price of HK$94.60 per Share, being the low end of the
indicative Offer Price range stated in this prospectus. Assuming an average cash burn rate
going forward of 1.2 times the level in 2024, we estimate that (i) our cash and cash equivalents
as of December 31, 2024 will be able to maintain our financial viability for 19 months, (ii) if
we take into account 10.0% of the estimated net proceeds from the Global Offering (namely,
the portion allocated for our working capital and other general corporate purposes), 21 months,
or, (iii) if we take into account all estimated net proceeds from the Global Offering, 39 months.
We will continue to monitor our cash flows from operations closely and expect to raise our next
round of financing no earlier than six months after the completion of the Global Offering.
Key Financial Ratios
The following table set forth our key financial ratios as of the dates indicated:
As of December 31,
2023 2024
Current ratio (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/H1118/H1118/H11180.5 0.5
Note:
(1) Current ratio represents current assets divided by current liabilities as of the same date.
SUMMARY
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RULE 13.46(2) OF THE LISTING RULES
Rule 13.46(2) of the Listing Rules requires an overseas issuer to send an annual report or
a summary financial report to its shareholders within four months after the end of the financial
year to which the report relates. Since (1) this prospectus already includes the financial
information of the Company for the year ended December 31, 2024 as required under Appendix
D2 to the Listing Rules in relation to annual reports; (2) we will not be in breach of the Articles
of Association, laws and regulations of the Cayman Islands or other regulatory requirements
as a result of not distributing such annual reports and accounts; and (3) we have complied with
the applicable code provisions in Part 2 of the Corporate Governance Code as set out in
Appendix C1 to the Listing Rules, we will not separately prepare and publish and send an
annual report to our Shareholders for the year ended December 31, 2024. In addition, we will
issue an announcement by April 30, 2025 stating that we will not separately prepare and send
an annual report to our Shareholders for the year ended December 31, 2024 as the relevant
financial information has been included in this prospectus. We will still comply with the
requirements under Rule 13.91(5) of the Listing Rules.
RISK FACTORS
Our business faces risks including those set out in the section headed “Risk Factors.” As
different investors may have different interpretations and criteria when determining the
significance of a risk, you should read the “Risk Factors” section in its entirety before you
decide to invest in our Company. Some of the major risks that we face include:
(i) If we are unable to successfully complete clinical development, obtain regulatory
approvals or achieve commercialization for our drug candidates, our business and
prospects could be materially and adversely affected;
(ii) We may from time to time be involved in legal proceedings and disputes to protect
or enforce our intellectual property rights, or defend against infringement and other
claims alleged by third parties;
(iii) We face intense competition and rapid technological change and the possibility that
our competitors may develop therapies that are similar, more advanced, or more
effective than ours;
(iv) The regulatory approval processes of the NMPA, the FDA and other comparable
regulatory authorities are time-consuming and may evolve over time;
(v) If we are unable to obtain or maintain approval from the NMPA, the FDA and other
comparable regulatory authorities for our drug candidates to be eligible for an
expedited registration pathway as innovative or breakthrough therapy, the time and
cost we incur to obtain regulatory approvals may increase;
SUMMARY
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(vi) Our future success depends on our ability to attract, retain and motivate senior
management, qualified medical professionals and scientific employees;
(vii) We have incurred net losses since our inception and anticipate that we will continue
to incur net losses for the foreseeable future and may never achieve or maintain
profitability;
(viii) We may fail to identify suitable business partners or may not realize the benefits of
such partnerships as expected;
(ix) Our business could be harmed if third parties suffer substantial disruption to supply
chain and production facilities, encounter problems in manufacturing or fail to
deliver sufficient quantities of product or at acceptable quality or price levels; and
(x) The future commercial success of our drug candidates will depend on the degree of
their market acceptance among physicians, patients and others in the medical
community.
PRE-IPO INVESTORS
Since the establishment of our Company, we have received four rounds of equity
financing totaling approximately US$137.5 million from our Pre-IPO Investors. Our Pre-IPO
Investors include certain Sophisticated Investors, such as King Star Med, Shanghai Yingjia,
Orchids and Golden Sword. Each Sophisticated Investor has made meaningful investment in
the Company at least six months before the Listing Date, holding approximately 7.92%, 7.68%,
4.52% and 4.01% of the total issued Shares immediately following the completion of the
Global Offering, assuming the Offer Size Adjustment Option and the Over-allotment Option
are not exercised, respectively. Pursuant to the lock-up undertakings given by the Pre-IPO
Investors to the Joint Sponsors, each Pre-IPO Investor, subject to the terms of such lock-up
undertakings, will not, whether directly or indirectly, at any time during the period agreed by
such Pre-IPO Investor and the Joint Sponsors dispose of any of the Shares held by such
Pre-IPO Investor. We utilized the proceeds to finance our ADC platforms discovery activities,
R&D development activities of pipeline products, as well as to support the working capital
needs of our Group. As of the Latest Practicable Date, all of the net proceeds from the Pre-IPO
Investments have been utilized for the aforementioned purposes. For further details of the
identity and background of our Pre-IPO Investors, and the principal terms of the Pre-IPO
Investments, please see “History and Corporate Structure — Pre-IPO Investments” in this
prospectus.
SUMMARY
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SHARE INCENTIVE PLAN
As of the Latest Practicable Date, we had one share incentive scheme, namely the Pre-IPO
Equity Incentive Plan, the terms of which are not subject to the provisions of Chapter 17 of the
Listing Rules. The maximum number of Shares that may be issued pursuant to the share awards
under the Pre-IPO Equity Incentive Plan shall not exceed 22,287,582 Shares in the aggregate.
We have conditionally granted all the options under the Pre-IPO Equity Incentive Plan, being
an aggregate of 22,287,582 options (representing the right to subscribe for 22,287,582 Shares)
(the “ Outstanding Pre-IPO Options ”) to 139 grantees, who are our current employees or
external consultants, under the Pre-IPO Equity Incentive Plan, all of which will remain
outstanding as of the Listing Date.
We are supported by a scientific advisory board of world-renowned ADC experts to guide
our R&D activities and provide invaluable strategic advice. To ensure consistent, high-quality
consulting services and align their interests with the Company’s long-term objectives, we have
granted options to three key external consultants who serve on this board. These options allow
them to subscribe for an aggregate of 300,000 Shares, representing approximately 0.36% of the
total number of Shares in issue immediately after completion of the Global Offering (assuming
the Offer Size Adjustment Option and the Over-allotment Option are not exercised). These
consultants have been engaged for a renewable three-year term to provide expert advice on
R&D activities, strategic developments, and/or regulatory affairs. To the best of our
Company’s knowledge, information and belief having made all reasonable enquiries, save for
Dr. SU Ling, a venture partner of Lilly Asia V entures, none of the external consultants have any
other past or present relationships with our Shareholders, Directors, senior management
members or any of their respective associates.
The number of the Shares underlying the Outstanding Pre-IPO Options amounting to
22,287,582 will only be issued by our Company after the Listing if such Outstanding Pre-IPO
Options are fully vested and exercised. Therefore, the Outstanding Pre-IPO Options will have
potential dilution effect on the Shares held by our Shareholders as of the Listing Date.
Assuming the Offer Size Adjustment Option and the Over-allotment Option are not exercised,
the shareholding of our Shareholders upon completion of the Global Offering will be diluted
by approximately 21.13% if the Outstanding Pre-IPO Options are fully vested and exercised.
For further details, please see “Statutory and General Information — D. Share Incentive Plan
— Pre-IPO Equity Incentive Plan” in Appendix IV to this prospectus.
DIVIDENDS
We did not declare or pay dividends on our Shares during the Track Record Period. We
currently expect to retain all future earnings for use in operation and expansion of our business,
and do not anticipate paying cash dividends in the foreseeable future. Our board of directors
has complete discretion as to whether to distribute dividends, subject to certain restrictions
under Cayman Islands law. In addition, our Shareholders may by ordinary resolution declare
a dividend, but no dividend may exceed the amount recommended by our board of directors.
Even if our board of directors decides to declare and pay dividends, the timing, amount and
SUMMARY
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--- page 37 ---
form of future dividends, if any, will depend on our future results of operations and cash flow,
our capital requirements and surplus, the amount of distributions, if any, received by us from
our subsidiaries, our financial condition, contractual restrictions and other factors deemed
relevant by our board of directors. Currently, we do not have any dividend policy or intention
to declare or pay any dividends in the near future. As advised by our legal advisor as to Cayman
Islands law, notwithstanding that the Company may have accumulated losses, the Company
may declare dividend (a) out of profits of the Company if the Company has sufficient profits,
realized or unrealized, unless such is contrary to the accounting principles adopted by the
Company or (b) out of the share premium of the Company if following the date on which the
dividend is proposed to be paid, the Company is able to pay its debts as they fall due in the
ordinary course of business. In determining whether to declare a dividend, our Board will need
to be satisfied that the declaration of dividend is in the best interest of the Company and may
make provision for losses. Investors should not purchase our Shares with the expectation of
receiving cash dividends.
OFFERING STATISTICS
(1)
Based on an
Offer Price
of HK$94.60
per Share
Based on an
Offer Price
of HK$103.20
per Share
Market capitalization of our Shares (2) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
HK$7,868.4
million
HK$8,583.7
million
Unaudited pro forma adjusted net tangible assets
of the Group per Share (3) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118HK$28.79 HK$30.28
Notes:
(1) All offering statistics in the table are on the assumptions that the Offer Size Adjustment Option and the
Over-allotment Option are not exercised.
(2) The calculation of market capitalization of our Shares is based on 83,175,764 Shares expected to be in
issue immediately after completion of the Global Offering.
(3) The unaudited pro forma adjusted consolidated net tangible assets attributable to owners of our
Company as of December 31, 2024 per Share is calculated after making the adjustments referred to in
“Appendix II — Unaudited Pro Forma Financial Information.”
USE OF PROCEEDS
We estimate that we will receive net proceeds from the Global Offering of approximately
HK$1,370.3 million, after deducting underwriting commissions, fees and estimated expenses
payable by us in connection with the Global Offering, and assuming an Offer Price of
HK$98.90 per Share, being the mid-point of the indicative Offer Price range stated in this
prospectus. We currently intend to apply these proceeds for the following purposes: (i)
approximately 45.0%, or HK$616.6 million, will be used for the research, development and
commercialization of our Core Products, namely, DB-1303 and DB-1311; (ii) approximately
SUMMARY
–2 7–


--- page 38 ---
30.0%, or HK$411.1 million, will be used for the research and development of our key
products; (iii) approximately 15.0%, or HK$205.5 million, will be used to fund the continued
development of our ADC technology platforms, advance our other pipeline assets, and explore
and develop new drug assets; and (iv) approximately 10.0%, or HK$137.0 million, will be used
for working capital and other general corporate purposes.
LISTING EXPENSES
Listing expenses to be borne by us are estimated to be approximately HK$120.3 million
(assuming an Offer Price of HK$98.90 per Share, being the mid-point of the indicative Offer
Price range of HK$94.60 to HK$103.20 per Share), representing approximately 8.1% of the
estimate gross proceeds from the Global Offering assuming no Shares are issued pursuant to
the Offer Size Adjustment Option and the Over-allotment Option. The listing expenses consist
of (i) underwriting-related expenses, including underwriting commission, of approximately
HK$67.1 million, and (ii) non-underwriting-related expenses of approximately HK$53.2
million, comprising (a) fees and expenses of our legal advisors and reporting accountants of
approximately HK$32.9 million, and (b) other fees and expenses of approximately HK$20.3
million. During the Track Record Period, listing expenses of RMB24.1 million (HK$26.5
million) was charged to our consolidated statements of profit or loss and RMB4.2 million
(HK$4.6 million) is expected to be accounted for as a deduction from equity upon the Listing.
After the Track Record Period, approximately HK$28.4 million is expected to be charged to
our consolidated statements of profit or loss, and approximately HK$60.8 million is expected
to be accounted for as a deduction from equity upon the Listing. The listing expenses above
are the latest practicable estimate for reference only, and the actual amount may differ from this
estimate.
RECENT DEVELOPMENTS AND NO MATERIAL ADVERSE CHANGE
Business Updates
Since the end of the Track Record Period, we have continuously developed our business
and continued to advance our pipeline. In January 2025, we entered into a collaboration
agreement with 3SBio Inc. (HKEX: 1530, “ 3SBio ”) through its subsidiaries, pursuant to which
we have appointed 3SBio as our commercialization partner in Mainland China, Hong Kong,
and Macau to promote DB-1303 for certain indications. For details, see “Business —
Commercialization — Partnership with 3SBio to Commercialize DB-1303 in the China
Market.”
As we strive to advance our pipeline and enhance our drug development capabilities, we
expect that we will continue to recognize net losses in 2025, primarily because (i) we will
continue to incur significant costs and expenses in relation to our R&D activities as we carry
out and expand our preclinical and clinical development programs, and (ii) we will incur fair
value change loss due to financial liabilities at fair value through profit or loss in relation to
our Preferred Shares prior to the Listing.
SUMMARY
–2 8–


--- page 39 ---
Regulatory Updates
The landscape of PRC cybersecurity, data privacy and security laws is also constantly
evolving. On September 30, 2024, the State Council promulgated the Administration
Regulations on Cyber Data Security ( ၣഖᅰኽτΌ၍ଣૢԷ) (the “ Data Security
Regulations ”), which came into effect on January 1, 2025. The Data Security Regulations
reiterate and refine the general regulations for cyber data processing activities, rules of
personal information protection, important data security protection, cyber data cross-border
transfer management, and the responsibilities of online platform service providers. For risks
relating to the evolving data privacy and cybersecurity laws and policies, see “Risk Factors —
Risks Relating to Government Regulations — We are subject to stringent data privacy and
cybersecurity laws and policies, and we may be restricted from transferring data abroad or
using human genetic resources collected within the PRC.” We will continue to closely monitor
and evaluate the potential impacts of the recent updates on Chinese data privacy policies on our
business and operations.
On February 21, 2025, U.S. President Donald J. Trump issued a memo entitled the
“America First Investment Policy” (the “ America First Memo ”), outlining the ongoing review
and consideration of potential new or expanded restrictions on U.S. outbound investment in the
PRC in sectors such as biotechnology, hypersonics, aerospace, advanced manufacturing, and
directed energy. The America First Memo also contemplates potential restrictions on
investments in publicly traded securities by pension funds, university endowments and other
limited partner investors. Such political tensions and policy changes could have an adverse
effect on global economic conditions, the stability of global financial markets, and
international trade policies. We will continue to monitor the future indications of such policies
and assess relevant risks.
No Material Adverse Change
Our Directors confirm that, except as disclosed above and up to the date of this
prospectus, there has been no material adverse change in our financial or trading position or
prospects since December 31, 2024, which is the end date of the periods reported on in the
Accountant’s Report included in Appendix I to this prospectus, and there is no event since
December 31, 2024 that would materially affect the information as set out in the Accountant’s
Report included in Appendix I to this prospectus.
IMPACT OF COVID-19
As of 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 in Shanghai and Beijing. 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, including securing IND approval from the FDA for DB-1303 in December 2021,
followed by IND approval from the NMPA in April 2022. 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 natural disasters, health epidemics,
acts of war or terrorism or other factors beyond our control.”
SUMMARY
–2 9–


--- page 40 ---
Unless the context otherwise requires, the following terms and expressions shall
have the meanings set out below. Certain technical terms are explained in the section
headed “Glossary of Technical Terms” in this prospectus.
“AACR” American Association for Cancer Research
“Accountant’s Report” the accountant’s report of our Company, the text of which
is set out in Appendix I to this prospectus
“Adcendo” Adcendo ApS, a biotech company organized under the
laws of Denmark on January 7, 2017
“affiliate” any other person, directly or indirectly, controlling or
controlled by or under direct or indirect common control
with such specified person
“AFRC” Accounting and Financial Reporting Council
“Articles” or “Articles of
Association”
the eighth amended and restated articles of association of
our Company conditionally adopted by a special
resolution passed on April 1, 2025 with effect from the
Listing Date, and as amended from time to time, a
summary of which is set out in “Summary of the
Constitution of our Company and Cayman Islands
Company Law” in Appendix III to this prospectus
“ASCO” American Society of Clinical Oncology Annual Meeting
“associate(s)” has the meaning ascribed to it under the Listing Rules
“Audit Committee” the audit committee of the Board
“BeiGene” BeiGene, Ltd., an exempted company with limited
liability incorporated under the laws of Cayman Islands
on October 28, 2010, whose shares are listed on the Hong
Kong Stock Exchange (HKEX: 6160), Nasdaq Stock
Market (Nasdaq: BGNE), and Shanghai Stock Exchange
(SSE: 688235)
DEFINITIONS
–3 0–


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“BioNTech” BioNTech SE, a European stock corporation (Societas
Europaea, or SE) under the laws of Germany and the
European Union whose shares are listed on the Nasdaq
Stock Market (Nasdaq: BNTX). The company was
incorporated on June 2, 2008 as Petersberg 91, V AG, a
German stock corporation
“Board” or “Board of Directors” the board of Directors of our Company
“business day” or
“Business Day”
any day (other than a Saturday, Sunday or public holiday
in Hong Kong) on which banks in Hong Kong are
generally open for normal banking business
“BVI” the British Virgin Islands
“Capital Market Intermediaries” the capital market intermediaries participating in the
Global Offering and has the meaning ascribed thereto
under the Listing Rules
“Cayman Companies Act” or
“Companies Act”
the Companies Act, Cap 22 (Act 3 of 1961, as
consolidated and revised) of the Cayman Islands as
amended, supplemented, or otherwise modified from
time to time
“CCASS” the Central Clearing and Settlement System established
and operated by HKSCC
“CDE” the Center for Drug Evaluation of the NMPA (ۜ
ᄲ൙ʕː), a division of the NMPA
mainly responsible for the review and approval of IND
and NDA/BLA
“China” or “Mainland China” or
“the PRC”
the People’s Republic of China excluding, for the purpose
of this prospectus and for geographical reference only,
Hong Kong, the Macau Special Administrative Region
and Taiwan
“CIT Law” Corporate Income Tax Law of the PRC ( ʕശɛ͏΍ձ਷
جwhich was adopted by the National
People’s Congress on March 16, 2007, as last amended
and effective on December 29, 2018
“close associate(s)” has the meaning ascribed to it under the Listing Rules
DEFINITIONS
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“Companies Ordinance” the Companies Ordinance (Chapter 622 of the Laws of
Hong Kong), as amended, supplemented or otherwise
modified from time to time
“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
“Company,” “our Company,”
or “the Company”
Duality Biotherapeutics, Inc. (يan exempted
company limited by shares incorporated in the Cayman
Islands on July 3, 2019
“Compliance Advisor” First Shanghai Capital Limited
“connected person(s)” has the meaning ascribed to it under the Listing Rules
“connected transaction(s)” has the meaning ascribed to it under the Listing Rules
“Core Product(s)” has the meaning ascribed thereto in Chapter 18A of the
Listing Rules; for the purpose of this prospectus, our
Core Products refer to DB-1303 and DB-1311
“CSRC” the China Securities Regulatory Commission ( ʕ਷ᗇՎ
ึ)
“Director(s)” the director(s) of our Company
“Duality Beijing” Beijing Duality Biologics Co., Ltd. (Ҧ
ʮ̡), a limited liability company incorporated
under the laws of the PRC on January 9, 2020, which is
a wholly-owned subsidiary of Duality Suzhou and one of
our wholly-owned subsidiaries
“Duality Shanghai” Duality Biologics (Shanghai) Co., Ltd. (Ҧ(ɪ
ऎ)ʮ̡), a limited liability company incorporated
under the laws of the PRC on April 26, 2020, which is a
wholly owned subsidiary of Duality Suzhou and one of
our wholly owned subsidiaries
DEFINITIONS
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“Duality Suzhou” Duality Biologics (Suzhou) Co., Ltd. (Ⴁᖹ(ᘽ
ψ)ʮ̡), a limited liability company incorporated
under the laws of the PRC on March 23, 2020, which is
a wholly owned subsidiary of DualityBio HK and one of
our wholly owned subsidiaries
“Duality U.S.” Dualitybio Inc., a limited liability company incorporated
under the laws of the State of Delaware of the United
States on May 3, 2021, which is one of our wholly owned
subsidiaries
“DualityBio HK” DualityBio HK Limited (ʮ̡), a
limited company incorporated in Hong Kong on January
21, 2020, which is one of our wholly owned subsidiaries
“EORTC” European Organization for Research and Treatment of
Cancer
“ESG” environmental, social and governance
“ESGO” European Society of Gynaecological Oncology Congress
“ESMO” European Society for Medical Oncology Congress
“Extreme Conditions” extreme conditions caused by a super typhoon as
announced by the government of Hong Kong
“FDA” the United States Food and Drug Administration
“FIL” the Foreign Investment Law of the PRC ( ʕശɛ͏΍ձ
) adopted by the National People’s
Congress on March 15, 2019 and became effective on
January 1, 2020
“FINI” Fast Interface for New Issuance, an online platform
operated by HKSCC that is mandatory for admission to
trading and, where applicable, the collection and
processing of specified information on subscription in
and settlement for all new listings
“Founder Holdco” DualityBio Ltd., a company with limited liability
incorporated under the laws of BVI and wholly owned by
Dr. ZHU Zhongyuan
DEFINITIONS
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“Frost & Sullivan” Frost & Sullivan (Beijing) Inc., Shanghai Branch Co.
“Frost & Sullivan Report” the report prepared by Frost & Sullivan as commissioned
by us
“FVTPL” fair value through profit or loss
“Global Offering” the Hong Kong Public Offering and the International
Offering
“Greater China” Mainland China, Hong Kong, the Macau Special
Administrative Region and Taiwan
“Group,” “our Group,”
“the Group,” “we,” “us,”
or “our”
our Company and its subsidiaries from time to time, and
where the context requires, in respect of the period prior
to our Company becoming the holding company of its
present subsidiaries, such subsidiaries as if they were
subsidiaries of our Company at the relevant time
“HK” or “Hong Kong” the Hong Kong Special Administrative Region of the
People’s Republic of China
“HKSCC” Hong Kong Securities Clearing Company Limited, a
wholly owned subsidiary of Hong Kong Exchanges and
Clearing Limited
“HKSCC EIPO channel” the application for the 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 an HKSCC
Participant to submit electronic application instructions
via FINI to apply for the Hong Kong Offer Shares on
your behalf
“HKSCC Nominees” HKSCC Nominees Limited, a wholly owned subsidiary
of HKSCC
DEFINITIONS
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“HKSCC Operational
Procedures”
the operational procedures of HKSCC, containing the
practices, procedures and administrative or other
requirements relating to HKSCC’s services and the
operations and functions of CCASS, FINI or any other
platform, facility or system established, operated and/or
otherwise provided by or through HKSCC, as from time
to time in force
“HKSCC Participant” a participant admitted to participate in CCASS as a direct
clearing participant, a general clearing participant or a
custodian participant
“Hong Kong dollars” or
“HK dollars” or “HK$”
Hong Kong dollars, the lawful currency of Hong Kong
“Hong Kong Offer Shares” the 1,507,200 Shares being initially offered by our
Company for subscription at the Offer Price pursuant to
the Hong Kong Public Offering (subject to reallocation as
described in the section headed “Structure of the Global
Offering” in this prospectus)
“Hong Kong Public Offering” the offer of the Hong Kong Offer Shares for subscription
by the public in Hong Kong
“Hong Kong Share Register” the register of members of our Shares maintained by the
Hong Kong Share Registrar
“Hong Kong Share Registrar” Computershare Hong Kong Investor Services Limited
“Hong Kong Underwriters” the underwriters of the Hong Kong Public Offering
“Hong Kong Underwriting
Agreement”
the Hong Kong underwriting agreement, dated April 3,
2025, relating to the Hong Kong Public Offering, entered
into by our Company, the Joint Sponsors, the Joint
Representatives and the Hong Kong Underwriters, as
further described in the section headed “Underwriting —
Underwriting Arrangements and Expenses — Hong Kong
Public Offering — Hong Kong Underwriting Agreement”
DEFINITIONS
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“IFRS(s)” International Financial Reporting Standards and
International Accounting Standards, which include
standards, amendments and interpretations promulgated
by the International Accounting Standards Board and the
International Accounting Standards and Interpretation
issued by the International Accounting Standards
Committee
“IFRS Accounting Standards” International Financial Reporting Standards issued by the
International Accounting Standards Board
“Independent Third Party(ies)” individual(s) or company(ies) which, to the best of our
Directors’ knowledge, information, and belief, having
made all reasonable enquiries, is/are not our connected
persons
“International Offer Shares” the 13,564,400 Shares being initially offered for
subscription under the International Offering, together,
where relevant, with any additional Shares which may be
issued pursuant to the exercise of the Offer Size
Adjustment Option and/or the Over-allotment Option,
subject to reallocation as described in the section headed
“Structure of the Global Offering” in this prospectus
“International Offering” the conditional placing of the International Offer Shares
at the Offer Price outside the United States in offshore
transactions in accordance with Regulation S and in the
United States to QIBs only in reliance on Rule 144A or
any other available exemption from the registration
requirements under the U.S. Securities Act, as further
described in the section headed “Structure of the Global
Offering” in this prospectus
“International Underwriters” the underwriters of the International Offering
“International Underwriting
Agreement”
the international underwriting agreement relating to the
International Offering to be entered into by our Company,
the Joint Sponsors, the Joint Representatives and the
International Underwriters on or about the Price
Determination Date
DEFINITIONS
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“Joint Bookrunners”,
“Joint Global Coordinators”,
“Joint Lead Managers”,
“Joint Representatives” or
“Joint Sponsors”
the joint bookrunners, joint global coordinators, joint
lead managers, joint representatives and joint sponsors as
named in the section headed “Directors and Parties
Involved in the Global Offering” in this prospectus
“Latest Practicable Date” March 28, 2025, being the latest practicable date for
ascertaining certain information in this prospectus before
its publication
“Listing” the listing of the Shares on the Main Board
“Listing Committee” the listing committee of the Stock Exchange
“Listing Date” the date, expected to be on or about Tuesday, April 15,
2025, on which the Shares are to be listed and on which
dealings in the Shares are to be first permitted to take
place on the Stock Exchange
“Listing Guide” the Guide for New Listing Applicants published by the
Stock Exchange, as amended, supplemented or otherwise
modified from time to time
“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
“Main Board” the stock exchange (excluding the option market)
operated by the Stock Exchange which is independent
from and operates in parallel with the GEM of the Stock
Exchange
“Memorandum” or
“Memorandum of Association”
the eighth amended and restated memorandum of
association of our Company conditionally adopted by a
special resolution passed on April 1, 2025 with effect
from the Listing Date, and as amended from time to time,
a summary of which is set out in “Summary of the
Constitution of our Company and Cayman Islands
Company Law” in Appendix III to this prospectus
DEFINITIONS
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“NMPA” the National Medical Products Administration of the PRC
(္ຖ၍ଣ҅), the successor to the China Food
and Drug Administration (္ຖ၍ଣᐼ҅)
“Nomination Committee” the nomination committee of the Board
“Offer Price” the final offer price per Offer Share (exclusive of
brokerage of 1.0%, SFC transaction levy of 0.0027%,
Stock Exchange trading fee of 0.00565% and AFRC
transaction levy of 0.00015%), expressed in Hong Kong
dollars, at which Hong Kong Offer Shares are to be
subscribed for pursuant to the Hong Kong Public
Offering and International Offer Shares are to be offered
pursuant to the International Offering, to be determined
as described in the section headed “Structure of the
Global Offering — Pricing and Allocation”
“Offer Share(s)” the Hong Kong Offer Shares and the International Offer
Shares
“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 Joint
Representatives (for themselves and on behalf of the
International Underwriters), pursuant to which our
Company may be required to allot and issue up to an
aggregate of 2,260,700 additional new Shares,
representing approximately 15% of the initial number of
the Offer Shares offered under the Global Offering, at the
Offer Price to cover any excess demand in the
International Offering, if any, details of which are
described in the section headed “Structure of the Global
Offering — Offer Size Adjustment Option”
“Overall Coordinators” the overall coordinators as named in the section headed
“Directors and Parties involved in the Global Offering”
DEFINITIONS
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--- page 49 ---
“Over-allotment Option” the option expected to be granted by our Company to the
International Underwriters, exercisable by the Joint
Representatives (for themselves and on behalf of the
International Underwriters) for up to 30 days from the
day following the last day for the lodging of applications
under the Hong Kong Public Offering, to require our
Company to allot and issue up to an aggregate of
2,260,700 additional 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
2,599,800 additional Shares (representing not more than
15% of the Offer Shares being offered under the Global
Offering assuming the Offer Size Adjustment Option is
exercised in full) at the Offer Price, to cover over-
allocations in the International Offering, if any, details of
which are described in the section headed “Structure of
the Global Offering — Over-allotment Option”
“PRC Legal Advisor” CM Law Firm, PRC legal advisor to our Company
“PRC Patent Law” the Patent Law of the PRC (ج,)
which was adopted by the National People’s Congress on
March 12, 1984, as last amended on October 17, 2020
and became effective on June 1, 2021
“Preferred Share(s)” the Series Seed Preferred Shares, Series A-1 Preferred
Shares, Series A-2 Preferred Shares, Series B-1 Preferred
Shares and Series B-2 Preferred Shares we issued during
the series financings
“Pre-IPO Equity Incentive Plan” the pre-IPO equity incentive plan adopted by our
Company on February 28, 2021 and amended on June 25,
2023, the principal terms of which are set out in the
section headed “Statutory and General Information — D.
Share Incentive Plan — Pre-IPO Equity Incentive Plan”
in Appendix IV
“Pre-IPO Investment(s)” the pre-IPO investment(s) in our Company undertaken by
the Pre-IPO Investors, details of which are set out in the
section headed “History and Corporate Structure —
Pre-IPO Investments” in this prospectus
DEFINITIONS
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“Pre-IPO Investor(s)” the investor(s) who participated in the Pre-IPO
Investments
“Price Determination Date” the date, expected to be on or about Friday, April 11,
2025 and in any event no later than 12:00 noon on Friday,
April 11, 2025, on which the Offer Price is to be fixed for
the purposes of the Global Offering
“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
“RMB” or “Renminbi” Renminbi, the lawful currency of the PRC
“Rule 144A” Rule 144A under the U.S. Securities Act
“SAFE” the State Administration of Foreign Exchange of the PRC
(̮ි၍ଣ҅)
“Series A-1 Investor(s)” the holder(s) of the Series A-1 Preferred Share(s)
“Series A-1 Preferred Share(s)” the series A-1 preferred share(s) of our Company with a
par value of US$0.0001 per Share
“Series A-2 Investor(s)” the holder(s) of the Series A-2 Preferred Share(s)
“Series A-2 Preferred Share(s)” the series A-2 preferred share(s) of our Company with a
par value of US$0.0001 per Share
“Series B Investor(s)” the holder(s) of the Series B-1 Preferred Share(s) and
Series B-2 Preferred Share(s)
“Series B-1 Preferred Share(s)” the series B-1 preferred share(s) of our Company with a
par value of US$0.0001 per Share
“Series B-2 Preferred Share(s)” the series B-2 preferred share(s) of our Company with a
par value of US$0.0001 per Share
DEFINITIONS
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“Series Seed Investor(s)” the holder(s) of the Series Seed Preferred Share(s)
“Series Seed Preferred Share(s)” the series seed preferred share(s) of our Company with a
par value of US$0.0001 per Share
“SFC” the Securities and Futures Commission of Hong Kong
“SFO” or “Securities and Futures
Ordinance”
Securities and Futures Ordinance (Chapter 571 of the
Laws of Hong Kong), as amended, supplemented or
otherwise modified from time to time
“Share(s)” or “Ordinary Share(s)” ordinary share(s) in the share capital our Company with
a par value of US$0.0001 each
“Shareholder(s)” holder(s) of our Share(s)
“Sophisticated Investor(s)” has the meaning ascribed to it under the Chapter 2.3 of
the Listing Guide
“Stabilizing Manager” Morgan Stanley Asia Limited
“Stock Borrowing Agreement” the stock borrowing agreement to be entered into between
DualityBio Ltd. and the Stabilizing Manager on or about
the Price Determination Date
“Stock Exchange” The Stock Exchange of Hong Kong Limited
“subsidiary(ies)” has the meaning ascribed to it in section 15 of the
Companies Ordinance
“substantial shareholder(s)” has the meaning ascribed to it in the Listing Rules
“Takeovers Code” Code on Takeovers and Mergers and Share Buy-backs
issued by the SFC, as amended, supplemented or
otherwise modified from time to time
“Track Record Period” the two years ended December 31, 2023 and 2024
“Treasury Share(s)” the Shares repurchased and held by the Company in
treasury, if any
“U.S. dollars,” “US$” or “USD” United States dollars, the lawful currency of the United
States
DEFINITIONS
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“U.S. Securities Act” the United States Securities Act of 1933, as amended, and
the rules and regulations promulgated thereunder
“U.S.” or “United States” the United States of America, its territories, its
possessions and all areas subject to its jurisdiction
“Underwriters” the Hong Kong Underwriters and the International
Underwriters
“Underwriting Agreements” the Hong Kong Underwriting Agreement and the
International Underwriting Agreement
“V A T” value-added tax
“White Form eIPO ” the application for Hong Kong Offer Shares to be issued in
the applicant’s own name by submitting applications online
through the designated website of the White Form eIPO
Service Provider, www.eipo.com.hk
“White Form eIPO Service
Provider”
Computershare Hong Kong Investor Services Limited
“%” per cent
For ease of reference, the names of Chinese laws and regulations, governmental
authorities, institutions, natural persons or other entities (including certain of our
subsidiaries) 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
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In this prospectus, unless the context otherwise requires, explanations and
definitions of certain terms used in this prospectus in connection with our Company
and our business shall have the meanings set out below. The terms and their meanings
may not always correspond to standard industry meaning or usage of these terms.
“advanced CRPC” metastatic and/or non-metastatic progressive castration-
resistant prostate cancer despite prior androgen
deprivation therapy
“advanced EC” locally advanced and/or metastatic endometrial cancer,
commonly refers to Stages III and IV EC
“ADA” anti-drug antibody, an antibody produced by the immune
system against a biologic. ADAs may adversely affect the
efficacy and safety of the biologic
“ADC” antibody-drug conjugate, a class of biopharmaceutical
drugs that comprise an antibody conjugated to a payload
molecule, typically a cytotoxic agent, via a chemical
linker
“ADCC” antibody dependent cell-mediated cytotoxicity or
antibody-dependent cellular cytotoxicity, a mechanism of
cell-mediated immune defense whereby an effector cell
of the immune system actively lyses a target cell whose
membrane-surface antigens have been bound by specific
antibodies
“ADT” androgen deprivation therapy, which is designed to either
stop testosterone from being produced or to directly
block it from acting on prostate cancer cells
“AE” adverse event, which may be mild, moderate, or severe,
any untoward medical occurrence in a patient or subject
receiving a drug or other pharmaceutical product in a
clinical trial and which does not necessarily have a causal
relationship with the treatment
“AESI” adverse event of special interest
“agonist” a chemical that binds to and activates a receptor or other
protein to produce a biological response
GLOSSARY OF TECHNICAL TERMS
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“AKT” a serine/threonine protein kinase with 3 isoforms (AKT1,
AKT2 and AKT3) that participate in multiple pathways
regulating several cellular processes, including survival,
proliferation, tissue invasion, and metabolism
“AUC” area under the curve, a pharmacokinetic parameter that
measures the body’s exposure to a drug, i.e., how much of
the drug reaches a person’s bloodstream over a given
period of time after a dose is administered
“BC” breast cancer
“BDCA2” Blood Dendritic Cell Antigen 2, a type II C-type lectin
receptor expressed on the surface of plasmacytoid
dendritic cells
“BICR” Blinded Independent Central Review, a process used in
clinical trials to ensure the objectivity and accuracy of
data analysis
“biomarker” a naturally occurring molecule, gene, or characteristic by
which a particular pathological or physiological process,
disease, etc. can be identified
“bispecific ADCs” or “BsADCs” a novel type of ADCs in which the payload molecule is
conjugated to a bispecific antibody which confers
targeting ability against two different antigens
“bispecific antibody” or “bsAb” an antibody that combines two antigen-recognizing
elements into a single construct, capable of binding to
two different antigens simultaneously
“BLA” biologics license application
“Breakthrough Therapy
Designation”
a designation by the NMPA and/or the FDA to expedite
the development and review of therapies intended for the
treatment of serious diseases for which there is no
effective treatment and where preliminary evidence
indicates the therapy may demonstrate a substantial
improvement over available treatment options
“BTC” biliary tract cancer
GLOSSARY OF TECHNICAL TERMS
–4 4–


--- page 55 ---
“bystander effect” a cytotoxic effect that occurs when the cytotoxic payload
from an ADC is released either from the target cell
following internalization and degradation of the ADC or
after cleavage within the extracellular space, resulting in
the payload being taken up by and killing surrounding
cells that may or may not express the ADC’s target
antigen
“B7H3” or “B7-H3” anti- B7 homolog 3 protein
“B7H4” or “B7-H4” anti- B7 homolog 4 protein
“CAGR” compound annual growth rate
“CC” cervical cancer
“CD276” cluster of differentiation 276, a molecule that regulates T
cell activation and function
“CDK” cyclin dependent kinase, a conserved family of proline-
directed serine/threonine kinases that perform critical
roles in regulating the stepwise progression through the
eukaryotic cell cycle
“CDK4” cyclin dependent kinase 4, a type of CDK
“CDK6” cyclin dependent kinase 6, a type of CDK
“CDMO” contract development and manufacturing organization, a
company that provides support to the pharmaceutical,
biotechnology, and medical device industries in the form
of development and manufacturing services outsourced
on a contract basis
“cell line” a population of cells which descend from a single cell and
contain the same genetic makeup, thereby producing the
same proteins. The productivity of a cell line determines
the cost of manufacturing, and the quality of a cell line is
directly related to the quality of the relevant biologics
“chemo naïve” a term used to describe patients who have not previously
received chemotherapy treatment
GLOSSARY OF TECHNICAL TERMS
–4 5–


--- page 56 ---
“chemotherapy” or “chemo” a drug treatment that uses cytotoxic chemicals to kill
fast-growing cells in a patient’s body. It is most often
used as a cancer treatment because cancer cells grow and
multiply much faster than most other cells in the body
“cGMP” current good manufacturing practice
“CLE” cutaneous lupus erythematosus
“C
max” maximum plasma concentration, a pharmacokinetic
parameter that measures the highest concentration of a
drug in the blood, cerebrospinal fluid, or target organ
after a dose is given
“CMC” chemistry, manufacturing and controls, also commonly
referred to as process development, covering the various
procedures used to assess the physical and chemical
characteristics of drug products, and to ensure their
quality and consistency during manufacturing
“cohort” a group of patients as part of a clinical trial who share a
common characteristic or experience within a defined
period and who are monitored over time
“combination therapy” a treatment that uses more than one medication or
modality
“CR” complete response, the disappearance of all signs of
cancer in response to treatment
“CRC” colorectal cancer, a type of cancer arising from the colon
or rectum
“CRPC” castration-resistant prostate cancer
“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
GLOSSARY OF TECHNICAL TERMS
–4 6–


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“CSO” contract sales organization, a company that provides
support to the pharmaceutical, biotechnology, and
medical device industries in the form of services for the
development and commercialization of new drugs,
medical devices, and other healthcare products
“cytokine” a broad category of small proteins that are important in
cell signaling, whose release has an effect on the
behavior of cells expressing corresponding receptors
“cytotoxic” toxic to living cells
“DAR” drug-to-antibody ratio, the average number of drug
molecules attached to each antibody in an ADC
“DC” dendritic cell
“DCR” disease control rate, the total proportion of patients who
demonstrate a response to treatment, equal to the sum of
complete responses (CR), partial responses (PR) and
stable disease (SD)
“DOR” duration of response, the length of time that a tumor
continues to respond to treatment without the cancer
growing or spreading
“DLT” dose-limiting toxicity, toxicities of a drug or other
treatment that are serious enough to prevent an increase
in dose or level of that treatment
“dose escalation study” a type of study where different doses of an agent (e.g. a
drug) are tested against each other to establish which
dose works best and/or is least harmful
“dose expansion study” a type of study that enrolls additional participants to
typically further evaluate efficacy, safety, tolerability,
pharmacokinetics, and pharmacodynamics
“EC” endometrial cancer
“EGFR” epidermal growth factor receptor
GLOSSARY OF TECHNICAL TERMS
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“EGFRm” or “EGFR-mutant” cells or tissues harboring mutations in the EGFR gene,
which can affect receptor function and are often
associated with certain types of cancer
“ERK” extracellular signal-regulated kinase
“ESCC” esophageal squamous cell carcinoma
“ET” endocrine therapy
“Fast Track Designation” or
“FTD”
a designation granted by the FDA to expedite the review
of drugs that treats serious or life-threatening condition
or address unmet medical needs to facilitate the
development of drugs
“Fc” crystallizable fragment, which is the tail region of an
antibody that interacts with cell surface receptors called
Fc receptors and some proteins of the complement system
“first-in-human” or “FIH” the initial clinical trials conducted in human subjects
after preclinical research and animal testing
“first-line” or “1L” with respect to any disease, the first line treatment refers
to the treatment regimen or regimens that are generally
accepted by the medical establishment for initial
treatment. It is also called primary treatment or therapy
“five-year survival rate” a type of survival rate used to estimate the prognosis of
a particular disease, referring to the percentage of
patients who are still alive five years after cancer
diagnosis
“FR/H9251” folate receptor alpha, a cell surface receptor that binds
and transports folate (vitamin B9) into cells
“GC” gastric cancer
“GCP” good clinical practice, an international ethical and
scientific quality standard for the performance of a
clinical trial on medicinal products involving humans
“GEA” gastroesophageal adenocarcinoma
“GJA” gastroesophageal junction adenocarcinoma
GLOSSARY OF TECHNICAL TERMS
–4 8–


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“glucocorticoid” steroid hormones produced by the adrenal glands that
regulate metabolism, immune response, and stress, and
are used to treat conditions like inflammation, allergies,
and autoimmune diseases
“GLP” good laboratory practice
“GR” glucocorticoid receptor
“HCC” hepatocellular carcinoma
“HER” human epidermal growth factor receptor, a group of four
closely related receptor tyrosine kinases that play
important roles in cell growth, survival, and
differentiation
“HER2” human epidermal growth factor receptor 2
“HER2-expressing” HER2 status of tumor cells identified with a test score of
IHC 1+ or above
“HER2-low” HER2 status of tumor cells identified with a test score of
IHC 1+ or IHC 2+/ISH-
“HER2m” HER2 status identified with one or more mutations, or
alterations, in the nucleotide sequence of HER2, which
may or may not result in HER2 amplification or
overexpression
“HER2-negative” or “HER2-” HER2 status of tumor cells identified with a test score of
IHC 0, IHC 1+ or IHC 2+/ISH-, which can be further
classified into HER2-low and HER2-null
“HER2-null” HER2 status of tumor cells identified with a test score of
IHC 0
“HER2-positive” or “HER2+” HER2 status of tumor cells identified with a test score of
either IHC 3+ or IHC 2+/ISH+
“HER3” human epidermal growth factor receptor 3
“HNSCC” head and neck squamous cell carcinoma
GLOSSARY OF TECHNICAL TERMS
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“HNSTD” the highest dose level that does not produce evidence of
lethality, life-threatening toxicities or irreversible
findings
“HR+” hormone receptor positive
“HR-” hormone receptor negative
“ICD” immunogenic cell death
“IFN/H9253” interferon gamma, a cytokine for activation and
regulation of the immune system
“IFN-I” type I interferon, a cytokine involved in the innate
immune response against viral infections and other
pathogens
“IgG” immunoglobulin G, the most common type of antibody
found in blood circulation that plays an important role in
antibody-based immunity against invading pathogens
“IgG1” immunoglobulin G1, a subclass of IgG
“immune checkpoint inhibitor(s)”
or “ICI(s)”
a type of immunotherapy that blocks proteins called
immune checkpoints, which prevent the immune system
from attacking the cancer cells
“immunotherapy” or “IO” a type of therapy that uses substances to stimulate or
suppress the immune system to help the body fight
cancer, infection, and other diseases
“IND” investigational new drug or investigational new drug
application, also known as clinical trial application in
China or the U.S.
“in vivo ” Latin for “within the living”, studies in vivo are those in
which the effects of various biological or chemical
substances are tested on whole, living organisms
including animals, humans and plants, as opposed to a
partial or dead organism, or those done in vitro
GLOSSARY OF TECHNICAL TERMS
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“in vitro ” Latin for “within the glass”, studies using components of
an organism that have been isolated from their usual
biological surroundings, such as microorganisms, cells or
biological molecules
“IRC” an independent review committee
“key opinion leaders” or “KOLs” experts and influencers who have significant knowledge
in a specific field
“LC” lung cancer
“linker” one of the three core components of an ADC. A linker
connects the antibody and payload via chemical bonds
“mAb” or “monoclonal antibody” an antibody generated by identical immune cells that are
all clones of the same parent cell
“Marketing Authorization
Holder” or “MAH”
an individual or entity that holds the license/legal
authorization to market and distribute a pharmaceutical
product in a specific jurisdiction
“MAPK” mitogen activated protein kinase, a type of protein kinase
that is specific to the amino acids serine and threonine
“mCRPC” metastatic castration-resistant prostate cancer
“melanoma” a form of skin cancer that arises when pigment-producing
cells, also known as melanocytes, mutate and become
cancerous
“metastatic” in reference to any disease, including cancer, disease
producing organisms or malignant or cancerous cells
transferred to other parts of the body by way of the blood
or lymphatic vessels or membranous surfaces
“MMAE” monomethyl auristatin E
“MNC” multinational companies
“MOA” mechanism of action
“monotherapy” therapy that uses a single drug to treat a disease or
condition
GLOSSARY OF TECHNICAL TERMS
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“MRCT” multi-regional clinical trial
“MTD” maximum tolerated dose, the highest dose of a drug or
treatment that does not cause unacceptable side effects
“NDA” new drug application
“NRDL” National Reimbursement Drug List
“NSAID” non-steroidal anti-inflammatory drug
“NSCLC” non-small cell lung cancer
“OC” ovarian cancer
“off-target toxicity” adverse effects that occur when a drug binds to targets
other than those for which it was designed to bind
“oncology” a branch of medicine that deals with tumors, including
the study of their development, diagnosis, treatment, and
prevention
“Orphan Drug Designation” a designation granted by the NMPA and/or FDA to a drug
or biological product intended to prevent, diagnose or
treat a rare disease or condition, qualifying the sponsors
for certain incentives
“ORR” overall objective response rate, the proportion of patients
with a complete response or partial response to treatment
“OS” or “overall survival” the length of time from either the date of diagnosis or the
start of treatment for a disease which patients diagnosed
with the disease are still alive. It is used in clinical trials
to measure a drug’s effectiveness
“payload” one of the three core components of an ADC. Payloads
are conventionally highly active and cytotoxic molecules
attached to an antibody via a chemical linker. Non-
cytotoxic payloads have recently emerged as novel ADC
strategies for oncology and non-oncology indications
“PC” prostate cancer
“pDC” plasmacytoid dendritic cell
GLOSSARY OF TECHNICAL TERMS
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“PDX model” a model of cancer where tissue or cells from a patient’s
tumor are implanted into an immunodeficient or
humanized mouse to evaluate the natural growth of the
cancer, its monitoring, and corresponding treatment for
the original patient
“PD-1” programmed cell death protein 1, an immune checkpoint
receptor expressed on T cells, B cells and macrophages
“PD-L1” PD-1 ligand 1, which is a protein on the surface of a
normal cell or a cancer cell that binds to its receptor,
PD-1, on the surface of the T cell that causes the T cell
to turn off its ability to kill the cancer cell
“PD-(L)1” referring to PD-1 or PD-L1
“PFS” progression free survival, the length of time during and
after the treatment that a patient lives without the disease
getting worse
“phase 1 clinical trial” a 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 2 clinical trial” a study in which a drug is administered to a limited
patient population to identify possible adverse effects and
safety risks, preliminarily evaluate the efficacy of the
product for specific targeted diseases, and determine
dosage tolerance and optimal dosage
“phase 3 clinical trial” a 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 product’s labeling
“pharmacokinetics” or “PK” a measurement of how fast and how completely a drug is
absorbed into animal or human body, including the
distribution, metabolism, and excretion of drugs in
animal or human body
GLOSSARY OF TECHNICAL TERMS
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“pivotal trial” a clinical trial or study designed to demonstrate clinical
efficacy and safety evidence required before submission
for drug marketing approval
“PI3K” phosphoinositide 3 kinase, an important signaling node
for many cellular functions such as growth control,
metabolism and translation initiation
“platinum-based chemotherapy” chemotherapy containing platinum complexes, which is
used to treat multiple types of cancers
“PR” partial response, defined as at least a 30% but less than
100% decrease in the size of a tumor or the extent of
cancer in the body in response to treatment, according to
RECIST
“proof-of-concept trial” an early clinical drug development phase aimed at
obtaining an initial evaluation of the potential efficacy of
a treatment
“Q2W” and “Q3W” dosing frequency referring to “once every two weeks”
and “once every three weeks,” respectively
“radionuclide drug conjugates” a novel form of drug conjugates composed of an antibody
linked to a radionuclide, a radioactive isotope, via a
chemical linker
“RCD” recommended combination dose
“RECIST” Response Evaluation Criteria in Solid Tumors, a set of
published rules that define when tumors in cancer
patients improve (“respond”), stay the same (“stabilize”),
or worsen (“progress”) during treatment with a focus on
measuring tumor size and its progress over time to assess
treatment effectiveness. The criteria were published in
February 2000 by an international collaboration
including the European Organization for Research and
Treatment of Cancer, National Cancer Institute of the
United States, and the National Cancer Institute of
Canada Clinical Trials Group. Now the majority of
clinical trials worldwide evaluating cancer treatments for
objective response in solid tumors use RECIST. These
criteria were developed and published in February 2000,
and subsequently updated in 2009
GLOSSARY OF TECHNICAL TERMS
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“rPFS” radiographic progression free survival, a clinical
endpoint commonly used in oncology trials to measure
the length of time from when a patient is randomly
assigned until objective tumor progression on imaging or
death, whichever occurs first
“RP2D” recommended phase 2 dose, typically the highest dose
with acceptable toxicity, usually defined as the dose level
that produces around 20% of dose-limiting toxicity
“SAE” serious adverse event, any medical occurrence in human
drug trials that, at any dose, results in death; is life-
threatening; requires inpatient hospitalization or prolongs
existing hospitalization; results in persistent or
significant disability/incapacity; may cause a congenital
anomaly/birth defect; or requires intervention to prevent
permanent impairment or damage
“SCLC” small-cell lung cancer
“second-line” or “2L” with respect to any disease, the therapy or therapies that
are given when initial treatments (first-line therapy) do
not work, or stop working
“SLE” systemic lupus erythematosus
“solid tumors” abnormal masses of tissue that usually do not contain
cysts or liquid areas. Solid tumors may be benign (not
cancer), or malignant (cancer). Different types of solid
tumors are named for the type of cells that form them,
such as carcinomas (cancers starting in epithelial cells)
and lymphomas (cancers originating in lymphocytes)
“standard of care” or “SoC” treatment accepted by medical experts as proper for a
certain type of disease and widely used by healthcare
professionals
“TAA” tumor-associated antigen, an antigen with elevated level
on tumor cells and lower levels on normal cells
GLOSSARY OF TECHNICAL TERMS
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“targeted therapy” a major type of treatment modalities that works by
targeting a particular molecule or molecules implicated in
or essential to the pathogenesis of cancer and non-
oncology indications, including but not limited to small
molecule drugs and monoclonal antibodies
“T cell” a lymphocyte produced or processed by the thymus
gland, actively participating in the immune response and
playing a central role in cell-mediated immunity. T cells
are distinguished from other lymphocytes, such as B cells
and NK cells, by the presence of a T cell receptor on their
surface
“TEAE” treatment-emergent adverse event, either an adverse
event that starts after the initiation of the study
medication or one that existed before study medication
but worsened in severity after the initiation of study
medication
“TGI” tumor growth inhibition, a measurement of the reduction
in the growth of tumors or tumor cells by a certain
treatment
“therapeutic window” the range of drug dosages that can treat disease
effectively without having toxic effects, or the time
interval during which a particular therapy can be given
safely and effectively
“third-line” or “3L” with respect to any disease, the therapy or therapies given
when both initial treatment (first-line therapy) and
subsequent treatment (second-line therapy) do not work,
or stop working
“TKI” tyrosine kinase inhibitor, a type of targeted therapy that
inhibits tyrosine kinases
“TME” tumor microenvironment
“TNBC” triple-negative breast cancer
“topoisomerase” any of a class of enzymes that reduce winding in DNA by
breaking and rejoining one or both strands of the DNA
molecule
GLOSSARY OF TECHNICAL TERMS
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“TRAE” treatment-related adverse event, an adverse event that, in
the investigator’s opinion, may have been caused by the
study medication with reasonable possibility
“TROP2” human trophoblast cell-surface antigen 2, a
transmembrane protein frequently over-expressed in
many types of solid tumors
“TTR” time to response, the time from the start of treatment to
the first objective tumor response observed in patients
who achieve a complete response (CR) or partial
response (PR)
“tumor growth inhibition” a measure of the reduction in the growth of tumors or
tumor cells by a certain treatment
“UC” urothelial cancer
“unresectable” referring to any tumor that cannot be surgically removed
due to factors making surgery either technically
impossible or medically inadvisable
“uORR” unconfirmed overall response rate, which is a metric used
to measure the proportion of patients who achieve a
complete or partial response to a treatment, but the
response has not yet been confirmed by follow-up
assessments. It is often used in early stages of clinical
trials to assess preliminary effectiveness. When
presenting preliminary efficacy data with a specific
cut-off date where confirmatory scans are still pending, it
is both scientifically necessary and ethically responsible
to appropriately label such responses as “unconfirmed.”
This classification adheres to established RECIST criteria
protocols and represents industry best practice for
transparent communication of emerging clinical data.
Regulatory authorities routinely evaluate unconfirmed
response data, recognizing its value in preliminary
assessment
“VEGF” vascular endothelial growth factor
GLOSSARY OF TECHNICAL TERMS
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This prospectus contains certain 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,” “believe,” “could,” “estimate,” “expect,” “going forward,”
“intend,” “may,” “might,” “ought to,” “plan,” “potential,” “predict,” “project,” “seek,”
“should,” “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 other
risk factors as described in this prospectus. Y ou are strongly cautioned that reliance on any
forward-looking statements involves known and unknown risks and uncertainties. The risks
and uncertainties facing our Company which could affect the accuracy of forward-looking
statements include, but are not limited to, the following:
 the timing of initiation and completion, and the progress of our preclinical studies
and clinical trials;
 the timing and likelihood of regulatory filings and approvals, such as INDs and new
drug applications (“ NDAs ”)/biologics license application (“ BLAs ”);
 our license and collaboration agreements;
 the market opportunities of our drug candidates;
 our operations and business prospects;
 our business strategies and plans to achieve these strategies;
 the competitive environment of the industry and markets in which we operate;
 the commercialization strategies and pricing policy of our drug candidates;
 our ability to defend our intellectual rights and protect our trade secrets;
 our financial conditions and operating results and performance;
 our ability to control costs and expenses;
 changes or volatility in interest rates, foreign exchange rates, equity prices, trading
volumes, commodity prices and overall market trends;
 changes to regulatory and operating conditions in the industry and markets in which
we operate;
FORW ARD-LOOKING STATEMENTS
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 general economic, political and business conditions in the markets in which we
operate;
 our future debt levels and capital needs;
 our ability to attract and retain senior management and key employees;
 certain statements in the sections headed “Business,” “Industry Overview” and
“Financial Information” in this prospectus with respect to trends in prices,
operations, margins, overall market trends, and risk management; and
 all other risks and uncertainties described in the section headed “Risk Factors” in
this prospectus.
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, the forward-looking statements are not a guarantee of future performance and you
should not place undue reliance on any forward-looking information. Moreover, the inclusion
of forward-looking statements should not be regarded as representations by us that our plans
and objectives will be achieved or realized. All forward-looking statements in this prospectus
are qualified by reference to the cautionary statements in this section.
In this prospectus, statements of or references to our intentions or those of the 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 Shares involves various risks. Y ou should carefully read and
consider all of the information in this prospectus, including the risks and uncertainties
described below before deciding to make any investment in our 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 Shares could decline and you may lose all
or part of your investment. Y ou should seek professional advice from your relevant
advisers regarding your prospective investment in the context of your particular
circumstances.
RISKS RELATING TO THE DEVELOPMENT OF OUR DRUG CANDIDATES
We depend substantially on the success of our drug candidates. If we are unable to
successfully complete clinical development, obtain regulatory approvals or achieve
commercialization for our drug candidates, or if we experience significant delays or cost
overruns in doing any of the foregoing, our business and prospects could be materially
and adversely affected.
Our revenue and profitability are substantially dependent on our ability to complete the
development of our drug candidates, obtain requisite regulatory approvals and successfully
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.
The success of our drug candidates will depend on a number of factors, including:
 favorable safety and efficacy data from our preclinical studies and clinical trials;
 sufficient resources to discover or acquire additional drug candidates and successful
identification of potential drug candidates based on our research or business
development methodology or search criteria and process;
 successful enrollment of patients in, and completion of, clinical trials;
 sufficient supplies of drug products that are used in our clinical trials;
 modifications to the protocols, which may delay the clinical program, regulatory
approvals or commercialization, and require us to supplement, modify, or withdraw
and refile our applications for regulatory approvals;
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 the performance by CROs, CDMOs, or other third parties we engage to conduct
clinical trials and preclinical studies and their compliance with our protocols and
applicable laws without damaging or compromising the integrity of the resulting
data;
 the capabilities and competence of our collaborators;
 the success of clinical trials conducted by, or jointly with, our collaborators;
 receipt of regulatory approvals for planned clinical trials or drug registrations,
manufacturing and commercialization;
 commercial manufacturing capabilities, including through the CDMOs we engage;
 successful launch of commercial sales of our drug candidates, if and when approved;
 the obtaining and maintenance of favorable reimbursement from third-party payers
for drugs, if and when approved;
 competition with other drug products;
 the obtaining, maintenance and enforcement of patents, trademarks, trade secrets
and other intellectual property protections and regulatory exclusivity for our drug
candidates;
 successful defense against any claims brought by third parties that we have
infringed, misappropriated or otherwise violated any intellectual property of any
such third party; and
 the continued acceptable safety profile of our drug candidates following regulatory
approval.
Some of our drug candidates represent a novel approach to therapeutic needs compared
with more commonly used modalities. For example, we have built a highly differentiated
portfolio of novel ADC drugs — one of the fastest-growing treatment modalities for cancers
with vast market potential. Our ADC assets and other drug candidates, given their novelty and
differentiated features, may carry inherent development risks that could result in delays and
cost overruns in clinical development, regulatory approvals or commercialization.
Furthermore, a substantial amount of education and training may need to be provided to
patients and medical personnel in connection with our drug candidates, which potentially
increases our sales and marketing expenses. This may have a material and adverse effect on
future profits generated from our drug candidates. For instance, our DB-1311 targets B7-H3,
a novel target for which no drug had been approved globally. We may not be able to generate
meaningful economic value taking into consideration the potentially significant efforts to
promote our novel ADC candidates, which in turn may materially and adversely affect our
competitive position, business, financial condition and results of operations.
RISK FACTORS
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As of the Latest Practicable Date, all of our drug candidates were in various phases of
preclinical and clinical development. If we fail to achieve drug development milestones as
disclosed in this prospectus, our business prospects could be adversely affected. Our costs will
also increase if we experience delays in the development of drug candidates or in obtaining
regulatory approvals, which could result in us having to delay or suspend the trial until
sufficient funding is procured, or we would have to abandon developing of the drug candidate
completely. Significant preclinical study or clinical trial delays also could allow our
competitors to bring products to market before we do and impair our ability to successfully
commercialize our drug candidates. Any of the above negative developments could have a
material and adverse effect on our business, financial condition and results of operation.
We face intense competition and rapid technological change and the possibility that our
competitors may develop therapies that are similar, more advanced, or more effective
than ours, which may adversely affect our financial condition and our ability to
successfully commercialize our drug candidates.
The biopharmaceutical industry in which we operate is intensely competitive and subject
to rapid and significant technological changes. While we focus on developing drug candidates
with the potential to become novel or highly differentiated drugs, we continue to face
competition with respect to our current drug candidates, and any drug candidates that we may
seek to develop or commercialize in the future. For instance, our Core Products, DB-1303 and
DB-1311, and other pipeline products may face competition from existing ADCs directed
against the same molecular targets and approved for the same target indications upon potential
marketing approval in the future.
Our competitors may include multinational pharmaceutical companies, biotechnology
companies, and research institutions worldwide. For example, in recent years, an increasing
number of biopharmaceutical companies have joined the competition in the research and
development of ADCs, with large pharmaceutical companies leading the competition and
biotechnology companies making frequent breakthroughs. Some of these competitive drugs
and therapies are based on scientific approaches that are similar to our approach. For details,
see “Business — Our Pipeline.” Potential competitors also include academic institutions,
governmental authorities and other public and private research organizations that invest in the
development, manufacturing and commercialization of innovative drugs.
Many of our competitors have substantially greater financial, technical, and other
resources than we do, such as those with larger research and development staff and established
marketing and manufacturing infrastructure. Collaborations, mergers and acquisitions in the
biopharmaceutical industry may result in even more resources being concentrated in our
competitors. As a result, these companies may be able to advance their drug candidates and
obtain regulatory approval from the regulatory authorities more rapidly than we do, and
become more effective in selling and marketing their products. Even if successfully developed
and subsequently approved by the NMPA, the FDA or other comparable regulatory authorities,
our drug candidates may still face competition in various aspects, including safety and efficacy,
the timing and scope of the regulatory approvals, the availability and cost of supply, sales and
marketing capabilities, price and patent status. Smaller or early-stage companies may also be
significant competitors, particularly through collaborative arrangements with large, established
companies.
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Competition may increase further as a result of advances in the commercial applicability
of technologies and greater availability of capital for investment in the industry. Our
competitors may succeed in developing, acquiring, or licensing on an exclusive basis, products
that are more effective or less costly than any drug candidate that we may develop, or achieve
earlier patent protection, regulatory approval, product commercialization, and market
penetration than we do. To compete with an approved product, we must demonstrate
compelling advantages in efficacy, safety or other aspects in order to overcome price
competition and to be commercially successful. Furthermore, disruptive technologies and
medical breakthroughs may further intensify the competition and render our drug candidates
uneconomical or obsolete, and we may not be successful in marketing our drug candidates
against competitors.
Clinical development involves a lengthy and expensive process with an uncertain
outcome, and results of preclinical studies and early phases of clinical trials may not be
predictive of future trial results.
Clinical development is expensive and can take many years to complete, and its outcome
is inherently uncertain. For instance, despite showing vast potential in clinical trials in the
1980s for cancer treatment, ADCs have presented a major scientific challenge to researchers
due to the high degree of technological sophistication required to design and produce a
balanced drug. Only in recent years have ADCs begun to gain momentum, as 11 of the 16
marketed ADCs to date were approved after 2019. For details, see “Industry Overview —
Antibody-drug Conjugates: A Precision Treatment Revolution — Evolution of ADCs.”
As of the Latest Practicable Date, several of our drug candidates, including our Core
Products DB-1303 and DB-1311, and key products DB-1310, DB-1305 and DB-1419, have
obtained IND approvals and are currently in clinical development. For details of our pipeline
and clinical development of our drug candidates, see “Business — Our Pipeline.” We may
encounter unexpected difficulties while executing our drug development plans for such drug
candidates and our current and future drug candidates are susceptible to the risks of failure
inherent at any stage of drug development, including the occurrence of unexpected or
unacceptable adverse events (“ AEs”) or the failure to demonstrate efficacy in clinical trials.
While we believe our drug candidates have the potential to be innovative and
differentiated globally, we cannot guarantee that we will be able to realize such potential for
any of our drug candidates, especially because they are still in clinical or preclinical
development. Failure can occur at any time during the drug development process, which would
result in a material and adverse effect on our business, financial condition and results of
operations. For instance:
 regulators, ethics committees, or other designated review bodies may not authorize
us or our investigators to commence a clinical trial or conduct a clinical trial at a
prospective trial site;
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 we might have to suspend or terminate clinical trials of our drug candidates for
various reasons, including negative results or a finding that participants are being
exposed to unacceptable health and safety risks;
 we may not be able to reach agreements on acceptable terms with prospective CROs
and hospitals as trial centers, the terms of which can be subject to extensive
negotiation;
 we may encounter various manufacturing issues, including inability to reach
agreements on acceptable terms with CDMOs, problems with quality control, or
ensuring sufficient quantities of our drug candidates for use in a clinical trial;
 subject enrolment may be insufficient or slower than we anticipate, or subjects may
drop out at a higher rate than anticipated;
 patent disputes or the failure to secure patents or other intellectual property
protection for our drug candidates may affect the drug development process; and
 our drug candidates may cause AEs and undesirable side effects, among other
unexpected characteristics, which could result in a suspension or termination of an
ongoing trial.
The results of preclinical studies and early clinical trials of our drug candidates may not
be predictive of the results of later-stage clinical trials. Drug candidates during later stages of
clinical trials may fail to show the desired results in safety and efficacy despite having
progressed through preclinical studies and initial clinical trials, and despite the level of
scientific rigor in the design of such studies and trials and the adequacy of their execution. In
some instances, there can be significant variability in safety and/or efficacy results among
different trials of the same drug candidate due to numerous factors, including differences in the
size and demographics of the enrolled patients, conditions of the individual subjects and their
adherence to the treatment regimen and other compounding factors, such as other medications
or pre-existing medical conditions. Differences in the number of clinical trial sites and regions
involved may also lead to variability between clinical trials.
Many companies in the biopharmaceutical industry have suffered significant setbacks in
advanced clinical trials due to a lack of efficacy or adverse safety profiles, notwithstanding
promising results at an earlier stage. We cannot guarantee that the results from our future
research and development efforts will be favorable based on currently available clinical and
preclinical data, which could result in delays in the completion of clinical trials, regulatory
approvals and commencement of commercialization of our drug candidates. See also “— Risks
Relating to Government Regulations — The regulatory approval processes of the NMPA, the
FDA and other comparable regulatory authorities are time-consuming and may evolve over
time. If we are unable to obtain without undue delay any regulatory approvals for our drug
candidates in our target markets, our business may be subject to actual or perceived harm.”
RISK FACTORS
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We may not be able to discover or identify new drug candidates, or to expand the
therapeutic opportunities for our drug candidates.
Besides the continued clinical testing, potential approvals and commercialization of our
existing drug candidates, the success of our business depends in part upon our ability to
discover or identify additional drug candidates. There can be no assurance that we will be
successful in identifying new drug candidates in the future. For example, although we have
developed our proprietary ADC technology platforms, which we believe enables us to design,
evaluate and select candidates and continue to enrich our pipeline, we cannot guarantee that we
will successfully identify potential drug candidates as expected. Some drug candidates may be
technically challenging to develop and manufacture. Drug candidates that we identify may later
show side effects or other characteristics that make them unmarketable or unlikely to receive
regulatory approvals. We have also pursued, and may continue to pursue, collaboration with
third parties in the discovery and development of potential drug candidates. However, there can
be no assurance that such license and collaboration will deliver the expected results.
Research programs to identify new drug candidates and to develop our drug candidates
for additional indications require substantial technical, financial, and human resources. We
may invest efforts and resources in potential drug candidates or indication expansions that
ultimately prove to be unsuccessful. Any of the foregoing events will have a material and
adverse effect on our business, results of operations and prospects.
We may allocate our limited resources to pursue a particular drug candidate or indication
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 on research programs
and drug candidates for specific indications. As a result, we may forgo or delay pursuit of
opportunities with other drug candidates or for other indications that later may prove to have
greater commercial potential or a greater likelihood of success. Our resource allocation
decisions may cause us to fail to capitalize on viable commercial products or profitable market
opportunities. 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, which
could materially adversely affect our future growth and prospects.
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If we encounter delays or difficulties enrolling subjects in our clinical trials, our clinical
development progress could be delayed or otherwise adversely affected.
We may not be able to initiate or continue clinical trials for our drug candidates if we are
unable to locate and enroll a sufficient number of eligible subjects to participate in these trials,
or if there are delays in the enrollment of eligible subjects as a result of the competitive clinical
enrollment environment. The inability to enroll a sufficient number of subjects who meet the
applicable criteria set out in the protocol could result in significant delays in our clinical trials.
In addition, some of our competitors may have ongoing clinical trials for drug candidates that
treat the same indications as our drug candidates, and subjects who would otherwise be eligible
for our clinical trials may instead enroll in the clinical trials of our competitors’ drug
candidates, which may further delay our clinical trial enrollments.
Subject enrollment for our clinical trials may be affected by a variety of factors, including
but not limited to the following:
 total size and nature of the relevant patient population;
 design and eligibility criteria for the clinical trial in question;
 perceived risks and benefits of the drug candidate under study;
 severity of the disease under investigation;
 our resources to facilitate timely subject enrollment in clinical trials;
 patient referral practices of physicians;
 availability of competing therapies also undergoing clinical trials;
 our ability to obtain and maintain subject consents;
 our investigators’ or clinical trial sites’ efforts to screen and recruit eligible patients;
 proximity and availability of clinical trial sites for prospective patients; and
 occurrence of natural disasters, health epidemics, acts of war or other public events.
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.
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Adverse events or undesirable side effects caused by our drug candidates could interrupt
or halt clinical trials, delay or prevent regulatory approval, limit the commercial profile
of an approved label, or result in significant negative consequences following any
regulatory approval.
AEs and undesirable side effects caused by our drug candidates could cause us or
regulatory authorities to interrupt or halt clinical trials and may result in a narrowed scope of
indications, a more restrictive label, a delay or denial of regulatory approval by the NMPA, the
FDA or other comparable regulatory authorities, or a significant change in our clinical protocol
or even our development plan. In particular, as is the case with other drugs treating cancers,
it is likely that there may be side effects associated with the use of certain of our drug
candidates. Results of trials conducted by us or by our collaboration partners with respect to
our drug candidates could reveal a high and unacceptable severity or prevalence of certain AEs,
including grade 3 or above TRAEs. In such an event, such trials could be suspended or
terminated and the NMPA, the FDA or other comparable regulatory authorities could order us
or our collaboration 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.
Additionally, if we, our collaboration partners, or others identify undesirable side effects
caused by our drug candidates after they receive regulatory approval, this may lead to
potentially significant negative consequences which include, but are not limited to, the
following:
 regulatory authorities may withdraw their approvals of or revoke the licenses for the
drug candidate;
 we, or our collaboration partners, may have to suspend marketing of the drug
candidate;
 regulatory authorities may require additional warnings on the label;
 the NMPA, the FDA or a comparable regulatory authority may require the
establishment of a Risk Evaluation and Mitigation Strategy (“ REMS ”), or similar
strategy that may, for instance, restrict distribution of our drugs and impose
burdensome implementation requirements on us;
 we, or our collaboration partners, may be required to conduct specific post-
marketing studies;
 we could become subject to litigation proceedings and held liable for harm caused
to subjects or patients; and
 our reputation may suffer.
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Further, combination therapy using our drug candidates together with third-party agents
may involve unique AEs that could be exacerbated compared with AEs from monotherapies.
Any of these events could prevent us or our collaboration partners, as applicable, from
achieving or maintaining market acceptance of any particular drug candidate that is approved
and could significantly harm our business, financial condition, results of operations and
prospects.
We may be unable to successfully develop or market our drug candidates or may
experience significant regulatory delays, if safety, efficacy or other issues arise from any
of our drug candidates or from any pharmaceutical product or medical treatment used,
or intended to be used, in combination with our drug candidates.
We plan to develop certain of our drug candidates for use as a combination therapy. For
instance, together with BioNTech, we are actively exploring the combination potential of our
Core Products and DB-1305. For details, see “Business — Our Pipeline.” We may also seek to
develop our drug candidates in combination with other drugs in the future. If the NMPA, the
FDA or another comparable regulatory authority revokes its approval of such treatments or
drugs we intend to use in combination with our drug candidates, we may not be able to develop
or market our drug candidates as a combination therapy as planned. If safety or efficacy issues
arise with such treatments or drugs that we seek to combine with our drug candidates in the
future, we may experience significant regulatory delays, and we may be required to redesign
or terminate the applicable clinical trials. For instance, we are investigating DB-1310’s
combination potential with osimertinib in EGFRm NSCLC patients resistant to osimertinib or
other third-generation tyrosine kinase inhibitor (“ TKI”) therapy. While this combination
strategy is designed to potentially address the challenge of osimertinib resistance, our success
will depend on demonstrating that DB-1310, when combined with osimertinib, can effectively
overcome resistance mechanisms and provide meaningful clinical benefit to patients. In
addition, if manufacturing or other issues result in a supply shortage of any drugs we use in
combination with, we may not be able to complete clinical development of our drug candidates
as a combination therapy on our current timeline or within our current budget, or at all.
In addition, we generally have no influence over the availability and pricing of such
drugs. If other pharmaceutical companies discontinue these combination drugs, or if these
drugs become prohibitively expensive, regimens that use these combination drugs may no
longer be prescribed, and we may not be able to introduce or find an alternative drug to be used
in combination with our drugs in a timely manner and on commercially reasonable terms, or
at all. As a result, clinical development of our drug candidates may be affected or future
demands for our drugs may be lowered, which would in turn materially and adversely affect
our business, financial condition, results of operations and prospects.
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The data and information we gather or otherwise rely on in our research and development
process could be inaccurate or incomplete, which could harm our trial results, reputation
and prospect.
We collect, aggregate, process, and analyze data and information from preclinical studies,
clinical trials and other research and development programs. We also engage in substantial
information gathering following the identification of a potential drug candidate. Because data
in the healthcare industry is fragmented in origin, inconsistent in format, and incomplete, the
overall quality of data collected or accessed is often subject to challenge, the degree or amount
of data which is knowingly or unknowingly absent or omitted can be material, and data issues
and errors are frequently discovered. If mistakes are made in the capture, input, or analysis of
these data, our ability to advance the development of our drug candidates may be materially
harmed and our business, prospects and reputation may suffer. We also engage in the
procurement of regulatory approvals necessary for the development and commercialization of
our products under development, for which we manage and submit data to governmental
entities. These processes and submissions are governed by complex data processing and
validation policies and regulations. We may be exposed to liability if it is concluded that our
storage, handling, submission, delivery, or display of health information or other data was
wrongful or erroneous.
In addition, we rely on third parties, including our collaborators, to collect, monitor and
manage data for some of the ongoing preclinical and clinical programs for our drug candidates
and have limited control over their activities. For instance, data from clinical trials conducted
or to be conducted by BioNTech, our collaboration partner, for DB-1303, DB-1311 and
DB-1305 outside Mainland China, Hong Kong and Macau may affect our clinical development
of these drug candidates in China. If there are any inaccuracies, mistakes or incompleteness in
the preclinical and clinical data of any of our collaborators, our clinical development activities
may be negatively impacted as a result.
We invest substantial human and capital resources in research and development in order
to develop our drug candidates and enhance our technologies, 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 significant efforts to develop our core technology platforms, including our
proprietary DITAC platform, DIBAC platform, DIMAC platform, and DUPAC platform which
allow us to continuously develop a strong pipeline of drug candidates. For details, see
“Business — Our Pipeline.” In 2023 and 2024, our costs and expenses in relation to R&D
activities, which represented our cost of revenue and research and development expenses, were
RMB986.7 million and RMB1,993.3 million, respectively. We intend to continue to strengthen
our technical capabilities in the development of our drug candidates, which requires substantial
capital and time. 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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RISKS RELATING TO DEPENDENCE ON THIRD PARTIES
We have entered into license and collaboration agreements with third parties in the
development, manufacturing and commercialization of our drug candidates, and may
seek and enter into additional partnerships in the future. We may fail to identify suitable
business partners or may not realize the benefits of such partnerships as expected.
We have in the past formed, and may continue to seek, strategic partnerships or other
collaborations, including entering into licensing arrangements with third parties that we
believe will complement or augment our drug development, manufacturing and
commercialization efforts with respect to our drug candidates and any future drug candidates
that we may develop. To date, we have entered into several out-licensing and collaboration
deals with leading industry players worldwide, including BioNTech, BeiGene and Adcendo.
See “Business — Our Collaboration and Licensing Arrangements” for details.
Our results of operations have been, and may continue to be, affected by our collaboration
and licensing arrangements. During the Track Record Period, substantially all of our revenue
was generated from such arrangements. Collaboration and licensing agreements involving our
drug candidates are subject to various risks, which may include the followings:
 collaborators have significant discretion in determining the efforts and resources
that they will apply to a collaboration;
 the collaboration and licensing agreements could be terminated upon a short notice,
and our collaborators may elect to cease collaboration due to change in their
strategic focus, potential acquisition of competitive drugs, availability of funding, or
other external factors;
 collaborators may delay clinical trials, provide insufficient funding for a clinical
trial, discontinue a clinical trial, repeat or conduct new clinical trials, or require a
new formulation of a drug candidate for clinical testing;
 the milestone payments and royalties under the agreements are conditioned upon the
achievements of certain regulatory, development and commercialization targets. We
cannot guarantee that we will be able to receive the aggregate amount as set out in
the relevant collaboration and licensing agreements;
 collaborators may not properly maintain or defend 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;
 disputes may arise between us and a collaborator that cause a delay or termination
of the research, development or commercialization of our drug candidates, or that
result in costly litigation or arbitration that diverts management attention and
resources;
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 collaborators could independently develop, or develop with third parties, drugs that
compete with our drug candidates or future drugs;
 collaborators may own or co-own intellectual property covering our drug candidates
or future drugs that results from our collaborating with them, and in such cases, we
would not have the exclusive right over such intellectual property; and
 the collaboration and licensing relationships may be affected by cross-border data
transmission restrictions and geopolitical tensions, including trade policies and
export controls.
For these and other reasons, we may not achieve the outcomes and synergies expected
from our collaboration and licensing arrangements. These collaboration and licensing
arrangements are inherently uncertain, and are subject to significant business, economic and
competitive uncertainties and contingencies, many of which are difficult to predict and are
beyond our control. We may face operational and financial risks including increase in near- and
long-term expenditures, exposure to unknown liabilities, disruption of our business and
diversion of our management’s time and attention. Even if we achieve the expected benefits,
we may not be able to do so within the anticipated time frame. In addition, any material and
adverse changes to our relationships with our collaborating partners may have an impact on the
technological and financial resources available to us under these collaboration and licensing
arrangements, which may in turn affect our R&D activities and business operations.
We face significant competition in seeking appropriate strategic partners and the
negotiation process can be time-consuming and complex. We may not be successful in our
efforts to establish a strategic partnership or other alternative 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 viability. If and when we
collaborate with a third party for development and commercialization of a drug candidate, we
may be required to relinquish some or all of the control over the future success of that drug
candidate to the third party. The collaborators may also consider alternative drug candidates or
technologies that may be available.
If we are unable to reach agreements with suitable collaborators on a timely basis, on
acceptable terms, or at all, we may have to curtail the development of a drug candidate, reduce
or delay its development program or one or more of our other development programs, delay its
potential commercialization or reduce the scope of any sales or marketing activities, or
increase our expenditures and undertake development, manufacturing or commercialization
activities at our own expenses. If we elect to fund and undertake development, manufacturing
or commercialization activities on our own, we may need to obtain additional expertise and
additional capital, which may not be available to us on acceptable terms or at all. Even with
existing collaboration agreements in place, we may not receive sufficient or timely
reimbursement from our collaborators for development costs, or our collaborators may delay
or withhold payments due to disputes over compliance with agreement terms or other factors.
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Additionally, development costs may exceed our initial estimates or agreed reimbursement
caps, requiring us to fund the excess amounts while any reimbursement disputes are being
resolved, which could be prolonged and may not result in full recovery of our costs. These
situations could strain our financial resources and potentially impair our ability to advance our
development programs as planned. If we fail to enter into collaboration and licensing
arrangements, face difficulties in securing adequate reimbursement from existing
collaborators, or do not have sufficient funds or expertise to undertake the necessary
development, manufacturing and commercialization activities, we may not be able to further
develop our drug candidates or bring them to market and generate product sales revenue, which
would harm our business, financial condition, results of operations and prospects.
As a result, we cannot be certain that, following a collaboration and licensing
arrangement, we will achieve the revenue or net income that justifies such transaction or such
other benefits that caused us to enter into the arrangement. Any of the foregoing could
materially and adversely affect our business, financial condition, results of operations and
prospects.
Our rights to develop and commercialize our drug candidates are subject, in part, to the
terms and conditions of licenses granted to us by others.
We rely on licenses to certain patent rights and other intellectual property from third
parties that are important or necessary to the development, manufacture or commercialization
of our certain drug candidates. For details, see “Business — Our Collaboration and Licensing
Arrangements.” The licenses we hold may not provide exclusive rights to use such intellectual
property in all relevant fields of use or in all territories in which we may wish to develop or
commercialize our future approved drugs. As a result, we may not be able to develop, export
or sell our drug products outside of the fields or territories as stipulated by the license and
collaboration agreements or prevent competitors from developing and commercializing
competitive drug products in territories included in all of our licenses. Our existing or future
collaboration partners may rely on third-party collaborators or on upstream licenses from third
parties.
In addition, 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 and components we license from third parties, or the technology underlying such
drug candidates and components. Therefore, we cannot be certain that these patents and patent
applications will be prepared, filed, prosecuted, maintained, enforced and defended in a
manner consistent with the best interests of our business. If our existing or future collaboration
partners fail to prosecute, maintain, enforce or defend such patents, or lose rights to those
patents or patent applications, the rights we have licensed may be reduced or eliminated, and
our right to research, develop and commercialize any of our drugs that are subject to such
licensed rights could be adversely affected.
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Such license agreements set out various procedures and timelines with respect to, among
other matters, clinical development, commercialization, and financial obligations such as
milestone payments and royalties. The terms of these agreements are complex and can be
subject to multiple interpretations. The resolution of any disagreements arising from these
agreements could, for example, eliminate or narrow what we believe to be the scope of our
rights to the relevant intellectual properties or technologies, or increase what we believe to be
our financial or other obligations under the relevant agreements. If we fail to comply with our
obligations under our current or future license agreements, our counterparties may have the
right to terminate such agreements, in which event we might lose the ability to develop,
manufacture or market certain drugs, or face claims for monetary damages or other penalties
under the respective agreements. Reduction or elimination of our rights under such agreements
may force us to negotiate new or restated agreements with less favorable terms, or cause
disruptions to our ongoing activities carried out in reliance of such rights, including our rights
to important intellectual properties and technologies.
Moreover, if any of our collaboration partners encounter financial problems, enter into
liquidation, dissolution, bankruptcy, or similar insolvency proceedings, or experience changes
in business focus, some or all of our rights under the license agreements may be affected. For
details, see “Business — Our Collaboration and Licensing Arrangements.” Any of these events
could have a material and adverse effect on our competitive position, business, financial
condition, results of operations and prospects.
We rely on third parties to monitor, support and/or conduct clinical trials and preclinical
studies of our drug candidates. If these third parties do not successfully carry out their
contractual duties or meet expected timelines, we may not be able to obtain regulatory
approval for, or commercialize, our drug candidates, and our business could be materially
affected.
We have relied on and plan to continue to rely on third-party CROs and other third parties
to monitor and manage data for some of our ongoing preclinical and clinical programs. We rely
on these parties for the execution of our preclinical 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 protocol and legal, regulatory and scientific
standards, and our reliance on the CROs and other third parties does not relieve us of our
regulatory responsibilities.
We and our CROs are required to comply with good clinical practice (“ GCP”), good
laboratory practice (“ GLP”) and other regulatory regulations and guidelines enforced by the
NMPA, the FDA and other comparable regulatory authorities for all of our drug candidates in
clinical development. Regulatory authorities may enforce these GCP , GLP or other regulatory
requirements through periodic inspections of trial sponsors, investigators and trial sites. In
addition, our clinical trials must be conducted with drug candidates or products manufactured
under current good manufacturing practice (“ cGMP ”) requirements.
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The CROs we engage may not always perform to our standards, may not produce results
in a timely manner or may fail to perform at all. Notwithstanding the remedies available to us
under our agreements with our CROs, we cannot control whether or not such CROs will devote
sufficient time and resources to our ongoing clinical, nonclinical and preclinical programs. If
we or any of our CROs fail to comply with the applicable GCP , GLP , cGMP or other regulatory
requirements, the relevant data generated in our clinical trials may be deemed unreliable and
the NMPA, the FDA or other comparable regulatory authorities may require us to perform
additional clinical trials before approving our marketing applications. There can be no
assurance the regulatory authorities will determine that our clinical trials comply with all the
applicable requirements. Failure to comply with these regulations may lead us to repeat
preclinical studies and clinical trials, which would delay the regulatory approval process.
Similarly, if other third parties fail to meet expected deadlines, timely transfer to us any
requisite information, adhere to protocols or act in accordance with regulatory requirements or
our agreements with them, or if they otherwise perform in a sub-standard manner or in a way
that compromises the quality or accuracy of their activities or the data they obtain, the clinical
trials of our drug candidates may be compromised, delayed, prolonged, suspended or
terminated, or our data may be rejected by the NMPA, the FDA, or other comparable regulatory
authorities.
Because we rely on third parties, our internal capacity to perform these functions is
limited. To the extent we are unable to identify and successfully manage the performance of
third-party service providers in the future, our business may be adversely affected. In addition,
the use of third-party service providers requires us to disclose our proprietary information or
confidential information concerning the subjects enrolled in our clinical trials to these third
parties, which could increase the risk that such information will be misappropriated. Though
we carefully manage our relationships with our CROs and other third-party service providers,
there can be no assurance that we will not encounter challenges or delays in the future or that
these delays or challenges will not have a material and adverse impact on our business,
financial condition, results of operations and prospects.
In addition, we may not be able to enter into arrangements with alternative CROs and
other third parties in a timely manner or do so on commercially reasonable terms, if our
existing relationships with these third parties terminate. Switching or adding CROs and other
third parties involves additional cost and delays, which can materially affect our ability to meet
our desired clinical development timelines. There can be no assurance that we will not
encounter similar challenges or delays in the future or that these delays or challenges will not
have a material adverse effect on our business, financial condition and prospects.
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We may rely on third parties to manufacture our drug products for clinical development
and commercial sales and to provide a stable and adequate supply of quality materials
and products for our drug development and commercialization needs. Our business could
be harmed if these third parties suffer substantial disruption to supply chain and
production facilities, encounter problems in manufacturing or fail to deliver sufficient
quantities of product or at acceptable quality or price levels.
To date, we have relied primarily on third-party service provides, including CDMOs, to
manufacture our drug candidates. See “Business — Manufacturing” for details. Going forward,
we intend to continue to engage third-party CDMOs to manufacture our drug candidates for our
research and development activities and commercial sales, while gradually establishing our
in-house manufacturing capabilities. Our reliance on third-party CDMOs exposes us to certain
risks, including, but not limited to, the following:
 we may be unable to identify CDMOs that may meet some or all acceptable terms
because the number of potential manufacturers is limited and the NMPA, the FDA
or other comparable regulatory authorities must approve any manufacturers as part
of their regulatory oversight of our drug candidates;
 our CDMOs may have limited capacity or limited manufacturing slots, which may
affect the timeline for the production of our drugs;
 our CDMOs are subject to periodic inspections and other government regulations by
the NMPA, the FDA or other comparable regulatory authorities, including to ensure
strict compliance with the cGMP . We do not have full control over our CDMOs’
compliance with these regulations and requirements;
 our CDMOs might be unable to timely manufacture our drug candidates or produce
the quantity and quality required to meet our clinical and future commercial needs,
if any;
 our CDMOs may not be able to execute our manufacturing procedures and other
logistical support requirements appropriately, or may otherwise fail to perform as
agreed;
 our CDMOs 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;
 our CDMOs may infringe, misappropriate, or otherwise violate the patent, trade
secret, or other intellectual property rights of third parties;
 our CDMOs could terminate their agreements with us;
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 raw materials and products supplied by certain CDMOs may not be readily
obtainable elsewhere; and
 our CDMOs and critical reagent suppliers may be subject to inclement weather, as
well as natural or man-made disasters, which may lead to interruption of supply.
See also “— Risks Relating to the Manufacturing and Commercialization of our Drug
Candidates — The manufacturing of biopharmaceutical products is a complex process, and we
have limited experience in manufacturing biopharmaceutical products on a large commercial
scale.”
In addition, during the Track Record Period, we and our CDMOs relied on third parties
to supply certain raw materials and products used in our research and development and clinical
trials. We expect to continue to rely on third parties to supply raw materials for the research,
development and commercialization of our drug candidates. Any disruption in production or
the inability of our suppliers or suppliers of our CDMOs to provide adequate quantities to meet
our or our CDMOs’ needs could impair our operations and the research and development of our
drug candidates. Moreover, we expect our demand for such raw materials and products to
increase as we expand our business scale and commercialize our drug candidates, but there is
no assurance that current suppliers have the capacity to meet our demand.
The quality of the raw materials procured and products manufactured by CDMOs will
depend significantly on the effectiveness of our quality control and quality assurance and that
of our CDMOs. We cannot assure you that these quality control and quality assurance
procedures will be effective in consistently preventing and resolving deviations from our
quality standards or that our operating procedures will be complete or updated at all times. Any
significant failure or deterioration of our quality control and quality assurance protocol or
standard operating procedures could render our products unsuitable for use, jeopardize our
drug approvals or licenses and/or harm our market reputation and relationship with business
partners. Any such developments may have a material and adverse effect on our business,
financial condition and results of operations.
If our business partners fail to maintain the necessary licenses for the development,
manufacturing and commercialization of our products, our business could be materially
affected.
Our business partners, such as CROs, CDMOs and suppliers, on whom we may rely on
to develop, manufacture, market, sell and distribute our drug candidates, may be subject to
requirement of obtaining and maintaining necessary permits, licenses and certificates in their
operations. Our business partners may also be subject to regular inspections, examinations,
inquiries or audits by the regulatory authorities, and an adverse outcome of such inspections,
examinations, inquiries or audits may result in the loss or non-renewal of the relevant permits,
licenses and certificates. If our business partners fail to maintain or renew material permits,
licenses and certificates, our ability to conduct our business could be materially impaired. Any
changes in the standards used by governmental authorities in considering whether to renew or
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reassess our business partners’ licenses, permits and certifications, as well as enactment of any
new regulations that may restrict the operation of our business partners’ operations, may also
decrease our revenue and increase our costs, which in turn could materially and adversely
affect our business, financial condition and results of operations.
We may fail to effectively manage our network of distributors after our drug candidates
are successfully launched. Actions taken by our distributors could materially and
adversely affect our business, prospects and reputation.
We may rely in part on third-party distributors to distribute our drug candidates upon their
commercialization. Our ability to maintain and grow our business will depend on our ability
to maintain an effective distribution channel that ensures the timely and effective delivery of
our products to the relevant markets. We cannot guarantee that we will be able to effectively
manage our distributors, or that our distributors would not breach the distribution agreements
and the policies and measures we have in place to manage their distribution. If our distributors
take one or more of the following actions, our business, results of operations, prospects and
reputation may be adversely affected:
 breaching the distribution agreements or our policies and measures;
 failing to maintain the requisite licenses, permits or approvals, or failure to comply
with applicable regulatory requirements when selling our products; or
 violating anti-corruption, anti-bribery, competition or other laws and regulations of
China or other jurisdictions.
Any violation or alleged violation by our distributors of the distribution agreements, our
policies or any applicable laws and regulations could expose us to liabilities and monetary
damages, a decrease in the market value of our brand and an unfavorable public perception
about the quality of our products, resulting in a material and adverse effect on our business,
financial condition, results of operations and prospects.
If we cannot maintain or develop clinical collaborations and relationships with principal
investigators, KOLs, physicians and other industry experts, our results of operations and
prospects could be adversely affected.
Our relationships with principal investigators, key opinion leaders (“ KOLs ”), physicians
and other industry experts play an important role in our research and development and
marketing activities. We have established extensive interaction channels with principal
investigators, KOLs, physicians and experts to gain first-hand knowledge of unmet clinical
needs and clinical practice trends, which is critical to our ability to develop market-responsive
drugs. However, we cannot assure you that we will be able to maintain or strengthen our
clinical collaborations and relationships with principal investigators, KOLs, physicians and
other industry experts, or that our efforts to maintain or strengthen such relationships will lead
to the successful development and marketing of new products.
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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. Even if their insights and perceptions
are correct, we may fail to develop commercially viable products. Industry participants may no
longer want to collaborate with us or attend our conferences, 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 and maintain our relationships with industry participants as anticipated, our
business, financial condition and results of operations may be materially and adversely
affected.
RISKS RELATING TO THE MANUFACTURING AND COMMERCIALIZATION OF
OUR DRUG CANDIDATES
The future commercial success of our drug candidates will depend on the degree of their
market acceptance among physicians, patients and others in the medical community.
Even if our drug candidates receive regulatory approval, they may nonetheless fail to gain
sufficient market acceptance by physicians and patients and others in the medical community.
Physicians and patients may prefer other drugs or drug candidates to ours. If our drug
candidates do not achieve an adequate level of acceptance, we may not generate significant
revenue from sales of our drugs or drug candidates and may not become profitable.
The degree of market acceptance of our drug candidates, if and only when they are
approved for commercial sale, will depend on a number of factors, including, but not limited
to:
 the clinical indications for which our drug candidates are approved;
 physicians, hospitals and patients considering our drug candidates as a safe and
effective treatment;
 whether our drug candidates have achieved the potential advantages of our drug
candidates over alternative treatments;
 the prevalence and severity of any side effects;
 product labeling or package insert requirements of the NMPA, the FDA or other
comparable regulatory authorities;
 limitations or warnings contained in the labeling approved by the NMPA, the FDA
or other comparable regulatory authorities;
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 timing of market introduction of our drug candidates, as well as competitive drugs
also on the market;
 cost of treatment in relation to alternative treatments;
 availability of adequate coverage and reimbursement under the national and
provincial reimbursement drug lists in the PRC, or from third-party payors and
governmental authorities in the United States or any other jurisdictions;
 willingness of patients to pay any out-of-pocket expenses in the absence of coverage
and reimbursement by third-party payors and governmental authorities;
 relative convenience and ease of administration, including as compared with
alternative treatments and competitive drugs on the market; and
 the effectiveness of our sales and marketing efforts.
If our drug candidates are approved but fail to achieve market acceptance among
physicians, patients, hospitals or others in the medical community, we will not be able to
generate significant revenue or become profitable. Even if our drugs achieve market
acceptance, we may not be able to maintain such market acceptance over time if new products
or technologies are introduced which are more favorably received or cost effective than our
drugs.
We have no experience in launching and marketing drug candidates. If we fail to
establish, expand and optimize an effective sales and distribution network for our drugs,
our business could be adversely affected.
Our operations to date have been largely focused on developing our drug candidates,
primarily undertaking preclinical studies and conducting clinical trials. To date, we have no
experience in marketing approved drugs. We may in the future develop an in-house marketing
and sales team, which will require significant capital expenditures, management resources and
time. We will have to compete with other biopharmaceutical companies to recruit, hire, train
and retain marketing and sales personnel.
We also plan to partnership with established commercial team externally for quick entries
into the market. 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 effective sales forces
and network will be established. Any revenue we receive will partially depend on the efforts
of such third parties, which may not be successful. We may have little or no control over the
marketing and sales efforts of such third parties, and our revenue from product sales may be
lower than if we had commercialized our drug candidates ourselves. See also “— Risks
Relating to Dependence on Third Parties — We may fail to effectively manage our network of
distributors after our drug candidates are successfully launched. Actions taken by our
distributors could materially and adversely affect our business, prospects and reputation.” We
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will also face competition in our search for reputable third parties to assist us with the sales
and marketing efforts of our drug candidates. There can be no assurance that we will be able
to develop in-house sales and marketing capabilities or establish or maintain relationships with
third-party collaborators to successfully commercialize any product, and as a result, we may
not be able to generate product sales revenue.
The size of the potential market for our current or future drug candidates is difficult to
estimate and, if any of our assumptions are inaccurate, the actual markets for our current
or future drug candidates may be smaller than our estimates.
Our projections of the number of patients who have the potential to benefit from treatment
with our drug candidates are based on our beliefs and estimates. These estimates have been
derived from a variety of sources, including scientific literature, surveys of clinics, patient
foundations, or 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 drug candidates may be smaller than our estimates. Furthermore, there
is no guarantee that any of our drug candidates, even if approved, would be approved for the
line of therapy we are aiming for. For example, cancer 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
and other comparable regulatory authorities may approve new therapies initially only for later
lines of therapy. While we may seek approval for our drug candidates 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.
Even if we are able to commercialize any approved drug candidates, reimbursement may
be limited or unavailable in certain market segments for our drug candidates, and we may
be subject to unfavorable pricing regulations, which could harm our business.
The regulations that govern regulatory approvals, pricing and reimbursement for new
therapeutic products vary widely from country to country. We intend to seek approval to market
our drug candidates in China, the U.S. and in other jurisdictions. In China, the pricing of
certain drugs and biologics is subject to governmental control, which can take considerable
time even after obtaining regulatory approval. Our 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.
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. In China, the Ministry of Human
Resources and Social Security of China, together with other government authorities, review the
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inclusion or removal of drugs from the China’s National Drug Catalog for Basic Medical
Insurance, Work-related Injury Insurance and Maternity Insurance (ᎈeʈ
ͦ፽), or the National Reimbursement Drug List (the “ NRDL ”),
regularly, and the tier under which a drug will be classified, both of which affect the amounts
reimbursable to program participants for their purchases of those drugs.
There can be no assurance that any of our future approved drug candidates will be
included in the NRDL. If we were to successfully launch commercial sales of our products but
fail in our efforts to have our products included in the NRDL, our revenue from commercial
sales would be highly dependent on patient self-payment, which can make our products less
competitive. Patients may choose other drugs with similar efficiency but lower price which
have been included in the NRDL. Additionally, even if the Ministry of Human Resources and
Social Security of China or any of its local counterparts were to accept our application for the
inclusion of products in the NRDL, our potential revenue from the sales of these products could
still decrease as a result of the significantly lowered prices we may be required to charge for
our products to be included in the NRDL.
In the U.S., 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 future approved drugs 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. Additionally,
third-party payers may not cover, or provide adequate reimbursement for, long-term follow-up
evaluations required following the use of our future approved drug candidates. Patients are
unlikely to use any of our future approved drug candidates unless coverage is provided and
reimbursement is adequate to cover a significant portion of the cost of the drugs.
We cannot be sure that reimbursement will be available for any approved drug candidates
that we commercialize 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. 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 also be significant delays in obtaining reimbursement for approved drug
candidates, and reimbursement coverage may be more limited than the approved indications of
the drug candidates by the NMPA, the FDA or other comparable regulatory authorities.
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. Payment rates may vary according to the uses of the drugs and the clinical setting
in which the drugs are 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. Our
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inability to promptly obtain reimbursement coverage at intended payment rates for our drug
candidates and any new drug candidates that we develop could have a material adverse effect
on our business, operating results, and overall financial conditions.
The manufacturing of biopharmaceutical products is a complex process, and we have
limited experience in manufacturing biopharmaceutical products on a large commercial
scale.
As of the Latest Practicable Date, we had not commercialized any drug candidates. As a
result, we have limited experience in manufacturing biopharmaceutical products on a
commercial scale, which is a complex process, in part due to strict regulatory requirements. We
cannot assure you that issues relating to the manufacturing of our drug candidates will not
occur in the future. We also face certain risks in relation to the CDMOs we engage for
manufacturing activities. See “— Risks Relating to Dependence on Third Parties — We may
rely on third parties to manufacture our drug products for clinical development and commercial
sales and to provide a stable and adequate supply of quality materials and products for our drug
development and commercialization needs. Our business could be harmed if these third parties
suffer substantial disruption to supply chain and production facilities, encounter problems in
manufacturing or fail to deliver sufficient quantities of product or at acceptable quality or price
levels.”
Issues may arise during the manufacturing process for reasons including: (i) equipment
malfunction, (ii) failure to follow specific protocols and procedures, (iii) problems with raw
materials, (iv) changes in manufacturing production sites or limits to manufacturing capacity
due to regulatory requirements, (v) changes in the type of products produced, (vi) advances in
manufacturing techniques, (vii) physical limitations that could inhibit continuous supply, and
(viii) the occurrence of natural disasters.
If problems arise during the production process of certain future products, 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 to the market, we may
incur additional costs in connection with product recalls and product liability.
We may not be able to maintain effective quality control over our drug products.
The quality of our products, including drug candidates we used for research and
development purposes, will depend significantly on the effectiveness of our quality control and
quality assurance, which in turn depends on factors such as the production processes, the
quality and reliability of equipment used, the capabilities of the CDMOs we engage and our
ability to ensure that they adhere to our quality control and quality assurance protocol. We
operate a comprehensive quality control system, which is established and refined in accordance
with the rigorous regulations and guidelines. See “Business — Quality Management.”
However, we cannot assure you that our quality control and quality assurance procedures will
be effective in consistently preventing and resolving deviations from our quality standards or
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that our standard operating procedures will be complete or updated at all times. 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, and/or harm our market reputation and relationship with business partners.
Any such developments may have a material and adverse effect on our business, financial
condition and results of operations.
Illegal and/or parallel imports and counterfeit pharmaceutical products may reduce
demand for our future approved drug candidates and could have a negative impact on our
reputation and business.
The illegal importation of competing products from countries where government price
controls or other market dynamics result in lower prices may adversely affect the demand for
our future approved drug candidates and, in turn, may adversely affect our sales and
profitability in China, the United States and other countries and regions where we
commercialize our products in the future. Illegal imports may continue to occur or even
increase as the ability of patients and other customers to obtain these lower priced imports
continues to grow. In addition, governmental authorities may expand consumers’ ability to
import lower priced versions of our future approved products or competing products.
Cross-border imports from lower-priced markets (which are known as parallel imports) into
higher-priced markets could harm sales of our future drug products and exert commercial
pressure on pricing within one or more markets. Any future legislation or regulations that
increase consumer access to lower priced medicines could have a material adverse effect on our
business.
Furthermore, certain products distributed or sold in the pharmaceutical market may be
manufactured without proper licenses or approvals, or be fraudulently mislabeled with respect
to their content or manufacturers. These products are generally referred to as counterfeit
pharmaceutical products. The counterfeit pharmaceutical product control and enforcement
system, particularly in developing markets such as China, may be inadequate to discourage or
eliminate the manufacturing and sale of counterfeit pharmaceutical products imitating our
products. Since counterfeit pharmaceutical products in many cases have similar appearances
compared with the authentic pharmaceutical products but are generally sold at lower prices,
counterfeits could quickly erode the demand for our drug candidates approved in the future. In
addition, thefts of our inventory at warehouses, plants or while in-transit could lead to our
products being wrongfully stored and handled, and eventually sold through unauthorized
channels. A patient who receives a counterfeit or unauthorized pharmaceutical product may be
at risk for a number of dangerous health consequences, which potentially exposes us to product
liability claims, government investigations, and other disputes and negative consequences. Our
reputation and business could suffer harm as a result of counterfeit or unauthorized
pharmaceutical products sold under our or our collaborators’ brand name(s).
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Negative results from off-label use of our future marketed drug products could harm our
reputation, product brand, business operations and financial condition and expose us to
liability.
Off-label drug use is the prescription of a product for an indication, dosage or in a dosage
form that is not in accordance with regulatory approved usage and labeling. For example,
certain HER2 ADCs have been prescribed off-label in selected patient populations before they
were approved for such use. While regulatory authorities including the FDA, NMPA, and other
comparable agencies strictly enforce regulations against the promotion of off-label use,
physicians may legally prescribe drugs for unapproved uses under certain circumstances.
Though a recognized aspect of medical practice, the prescription of our drug products outside
their approved indications, patient populations, or dosing parameters could lead to potential
risks arising from insufficient safety/efficacy data, regulatory compliance challenges,
reimbursement issues, and the need for enhanced monitoring and documentation. Off-label use
could also render our products less effective or entirely ineffective and may cause unexpected
adverse drug reactions or AEs. Any of these occurrences can create negative publicity and
materially and adversely affect our business reputation, product brand, business operations and
financial conditions. These occurrences may also expose us to liability and cause a delay in the
progress of our clinical trials and may ultimately result in failure to obtain regulatory approval
for our drug candidates
RISKS RELATING TO OUR FINANCIAL POSITION AND NEED FOR ADDITIONAL
CAPITAL
We are a clinical-stage 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 clinical stage 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. We have not yet demonstrated an
ability to successfully obtain marketing approvals for, or commercialize, our drug candidates.
To date, we have no products approved for commercial sale and have not generated any
revenue from product sales.
Our limited operating history, particularly in light of the rapidly evolving drug research
and development industry in which we operate 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 will suffer.
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We have incurred net losses since our inception and anticipate that we will continue to
incur net losses for the foreseeable future and may never achieve or maintain profitability.
Investment in the development of biopharmaceutical products is highly uncertain 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. We have not generated any revenue from commercial product sales to
date, and we continue to incur significant research and development costs and other expenses
related to our ongoing operations. As a result, we have incurred net losses in 2023 and 2024
of RMB357.5 million and RMB1,050.4 million, respectively.
Our net losses during the Track Record Period were primarily attributable to expenses
incurred by our research and development activities, including those in relation to our
preclinical studies and clinical trials, as well as fair value change of financial liabilities at fair
value through profit or loss in relation to our Preferred Shares. In 2023 and 2024, our costs and
expenses in relation to R&D activities, which represented our cost of revenue and research and
development expenses, were RMB986.7 million and RMB1,993.3 million, respectively. During
the same periods, we recorded fair value loss of financial liabilities at fair value through profit
or loss of RMB1,017.9 million and RMB873.4 million, respectively. See “Financial
Information — Description of Selected Components of the Consolidated Statements of
Comprehensive Loss” for details. Our ability to generate revenue and achieve profitability
depends significantly on our success in advancing these 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 net losses in the foreseeable future, and that these net
losses may increase as we carry out certain activities relating to our development, including,
but not limited to, the following:
 continue our ongoing and planned research and development activities;
 seek to discover, identify or develop additional drug candidates and further expand
our product pipeline;
 continue to scale up our business to meet the requirements for our R&D activities,
clinical trials and potential commercialization;
 hire additional drug discovery, clinical, quality control and administrative
personnel;
 develop, maintain, expand and protect our intellectual property portfolio;
 seek regulatory approvals for any drug candidates that successfully complete
clinical trials;
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 establish sales, marketing and distribution infrastructure to commercialize any drug
candidate for which we may obtain regulatory approval;
 expand our operations globally; and
 incur additional legal, accounting, investor relations, insurance and other expenses
associated with operating as a public company following the completion of this
offering.
The size of our future net losses will depend, among other factors, on the rate of the future
growth of our expenses, our ability to generate revenues and the timing and amount of
milestone payments and other payments that we receive from or pay to third parties. If any of
our drug candidates fails during clinical trials or does not gain regulatory approval, or, even
if approved, fails to achieve market acceptance, our business may not become profitable. Even
if we achieve profitability in the future, we may not be able to sustain profitability in
subsequent periods thereafter. Our prior losses and expected future losses have had, and will
continue to have, an adverse effect on our business, financial condition and results of
operation.
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, we had net liabilities of RMB1,123.9 million and
RMB2,021.9 million, respectively. The increase from December 31, 2023 to December 31,
2024 was primarily due to an increase in financial liability at fair value through profit or loss
(“FVTPL ”) mainly as a result of changes in fair value of our Preferred Shares, partially offset
by an increase in cash and cash equivalents as a result of increased revenue from our
out-license and collaboration agreements. In addition, we had net current liabilities of
RMB1,227.4 million and RMB1,961.7 million as of December 31, 2023 and 2024, respectively,
primarily because our Preferred Shares issued to Pre-IPO investors are recorded as current
liabilities under financial liabilities at FVTPL. A net liabilities position and net current
liabilities position can expose us to liquidity and financial risks. This in turn could require us
to seek financing from external sources such as debt issuance and bank borrowings, which may
not be available on terms favorably or commercially reasonable to us, or at all. See also “—
Risks Relating to Our Financial Position and Need for Additional Capital — 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.”
We may experience net cash outflows from our operating activities from time to time. See
also “Financial Information — Liquidity and Capital Resources — Working Capital
Sufficiency.” Our forecast of the period of time through which our capital resources will be
adequate to support our operations is a forward-looking statement and involves risks and
uncertainties. We have based this estimate on assumptions that may prove to be wrong, and we
could exhaust our available capital resources sooner than we currently expect.
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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 are subject to credit risk associated with our trade receivables. Payment delays or
defaults may affect our cash flow and results of operation.
We are subject to credit risk in collecting the trade receivables. Our trade receivables
amounted to RMB100.8 million and RMB379.0 million as of December 31, 2023 and 2024,
respectively. There can be no assurance that future trade receivables incurred during our
ordinary course of business would be settled on time. Accordingly, we face credit risk in
collecting trade receivables due to us. Our liquidity and financial position would be adversely
affected if significant amounts due to us are not settled on time or substantial impairment is
incurred.
We may incur impairment losses for intangible assets, which could negatively affect our
results of operations and financial condition.
We had intangible assets of RMB54.2 million and RMB46.2 million as of December 31,
2023 and 2024, respectively. Our intangible assets primarily consisted of (i) in-licenses,
primarily in relation to certain antibodies we licensed in from third parties, and (ii) software.
See “Financial Information — Description of Selected Items from the Consolidated Balance
Sheets — Intangible Assets” for details.
If the carrying value of our intangible assets is considered to exceed its recoverable
amount and is therefore determined to be impaired in the future, we would be required to write
down the carrying value or record a provision of impairment loss for these intangible assets in
our financial statements during the period in which our intangible assets are determined to be
impaired. The intangible assets related to in-licenses are subject to annual impairment test
based on the recoverable amount of the cash-generating unit to which the intangible asset is
related to. The annual impairment test was performed by engaging an independent valuer to
estimate fair value less cost to sell as the recoverable amount. The fair value is based on the
multi-periods excessive earning method with key assumptions. For more details, please refer
to note 16 to the Accountant’s Report set out in Appendix I to this prospectus. Impairment
losses for intangible assets would adversely affect our results of operations and our financial
condition.
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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 funded our operations primarily through equity
financing and revenue from our out-licensing and collaboration agreements. We expect our
expenses to increase significantly in connection with our ongoing activities, particularly as we
advance the clinical development of our clinical-stage drug candidates, continue the research
and development of our preclinical stage drug candidates and initiate additional clinical trials
of, and seek regulatory approval for, these and other future drug candidates. In addition, if we
obtain regulatory approvals for any of our drug candidates, we expect to incur significant
commercialization expenses relating to product manufacturing, marketing, sales and
distribution and post-approval commitments to continue monitoring the efficacy and safety
data of our future products on the market. We may also incur expenses as we create additional
infrastructure to support our operations as a public company. Accordingly, we may need to
secure substantial additional funding in connection with our continuing operations through
public or private equity offerings, debt financing, collaborations or licensing arrangements or
other sources.
We expect to fund our future operations primarily with existing cash and cash equivalents,
revenue from our out-license and collaboration agreements, and proceeds from the Global
Offering. Upon the successful commercialization of one or more of our drug candidates, we
expect to fund our operations in part with income generated from sales of our commercialized
drug products. Changes in our ability to fund our operations may affect our cash flow and
results of operations. If we are unable to raise capital when needed or on acceptable terms, we
could be forced to delay, limit, reduce or terminate our research and development programs or
any future commercialization efforts.
We have granted, and may continue to grant, certain awards under our share incentive
plan, which may result in increased share-based compensation expenses.
We have adopted a share incentive plan for the purpose of granting share-based
compensation awards to employees, officers, or directors to incentivize their performance and
align their interests with ours. In 2023 and 2024, we incurred RMB24.0 million and RMB190.4
million of share-based compensation expenses relating to share options granted under our share
incentive plan, respectively. We believe the granting of share-based compensation is of
significant importance to our ability to attract and retain key personnel and employees, and we
may continue to grant share-based compensation awards to employees in the future. As a result,
our expenses associated with share-based compensation may increase, which may affect our
financial condition and results of operations. We may re-evaluate the vesting schedules,
lock-up period, exercise price or other key terms applicable to the arrangements under our
currently effective employee stock option plans from time to time. If we choose to do so, we
may experience substantial change in our share-based compensation charges in the reporting
periods following this Offering.
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We have historically received financial incentives, such as government subsidies, and we
may not continue to receive such incentives in the future.
We have historically received various government subsidies, including subsidies from
different PRC governmental authorities to support the research and development for our drug
candidates. We recognized government grants as other income of RMB3.2 million and RMB7.1
million for the years ended December 31, 2023 and 2024, respectively. There is no assurance
that we could continue to enjoy or maintain financial incentives or government subsidies at the
historical levels, or at all, or apply for new financial incentives or government subsidies. Any
change, suspension or termination of these government subsidies, or government financial
incentives in other forms, may have a negative impact on our business, financial condition and
results of operations.
Fluctuations in exchange rates could result in foreign currency exchange losses.
The Renminbi has fluctuated against the Hong Kong dollar and U.S. dollar, at times
significantly and unpredictably. In 2023 and 2024, we recorded net foreign exchange gains of
RMB41.9 million and RMB12.3 million, respectively. There is no assurance that we will
continue to incur foreign exchange gains in the future or our foreign exchange losses will not
incur in the future. The value of Renminbi against the U.S. dollar and other currencies is
affected by changes in political and economic conditions and by foreign exchange policies,
among other things. We cannot assure you that Renminbi will not appreciate or depreciate
significantly in value against the Hong Kong dollar or U.S. dollar in the future. It is difficult
to predict how market forces or PRC or U.S. government policy may impact the exchange rate
between Renminbi and the Hong Kong dollar or U.S. dollar in the future.
The proceeds from the Global Offering will be received in Hong Kong dollars. As a result,
any appreciation of the Renminbi against the U.S. dollar, the Hong Kong dollar or any other
foreign currencies may result in the decrease in the value of our proceeds from the Global
Offering. Conversely, any depreciation of the Renminbi may adversely affect the value of, and
any dividends payable on, our Shares in foreign currency. In addition, there are limited
instruments available for us to reduce our foreign currency risk exposure at reasonable costs.
Furthermore, we are also currently required to complete filings with and obtain approvals from
the State Administration of Foreign Exchange of the PRC (the “ SAFE ”) before converting
significant sums of foreign currencies into Renminbi. All of these factors could materially and
adversely affect our business, financial condition, results of operations and prospects, and
could reduce the value of, and dividends payable on, our Shares in foreign currency terms.
Disruptions in the financial markets and economic conditions could affect our ability to
raise capital.
Global economies could suffer dramatic downturns as the result of a deterioration in the
credit markets and related financial crisis as well as a variety of other factors including,
extreme volatility in security prices, severely diminished liquidity and credit availability,
ratings downgrades of certain investments and declining valuations of others. In the past,
governments have taken actions in an attempt to address and rectify these market and economic
conditions by providing liquidity and stability to the financial markets. If these actions are not
successful, the return of adverse economic conditions may cause a significant impact on our
ability to raise capital, if needed, on a timely basis and on acceptable terms.
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In addition, concerns over the recent conflicts in the Middle East, Russian-Ukraine
conflicts, and unrest and terrorist threats in other territories, among others, add uncertainties
to the financial markets worldwide. It is unclear whether these challenges and uncertainties
will be contained or resolved, and what effects they may have on the global political and
economic conditions in the long term. See also “— Risks Relating to Our Operations — We
may be exposed to risks of conducting our business and operations in international markets.”
RISKS RELATING TO INTELLECTUAL PROPERTY RIGHTS
We may from time to time be involved in legal proceedings and disputes to protect or
enforce our intellectual property rights, or defend against infringement and other claims
alleged by third parties, which could be expensive, time consuming and unsuccessful.
Litigation relating to patents and other intellectual property rights in the
biopharmaceutical and pharmaceutical industries is common, including patent administrative
proceedings, patent ownership and patent infringement lawsuits. The various markets in which
we plan to operate are subject to frequent and extensive litigation regarding patents and other
intellectual property rights. Third parties could resort to litigation against us or other parties
we have agreed to indemnify, which litigation could be based on either existing intellectual
property or intellectual property that arises in the future. Some claimants may be able to sustain
the costs of complex intellectual property proceedings to a greater degree and for longer
periods of time than we could.
Despite measures we take to obtain and maintain patent and other intellectual property
rights with respect to our drug candidates, our intellectual property rights could be challenged
or invalidated. We have in the past been, and may in the future be, involved in legal
proceedings where third parties may challenge our intellectual property rights. In such
instances, we may need to take action to enforce or defend our intellectual property rights. For
example, we are currently involved in certain legal proceedings where a third party filed claims
against us alleging ownership rights to certain of our patent applications. Some of these patent
applications were related to parts of the molecular structures derived from our proprietary
technology platforms and used in certain of our ADC candidates, including clinical-stage assets
(such as our Core Products). These cases are still ongoing as of the date of this prospectus. For
details, see “Business — Legal Proceedings and Compliance.” Failure to successfully defend
against such claims may result in adverse court rulings affecting our ownership of certain
patent rights. Such outcomes could result in limitations to our control over the affected patents,
including allowing others to utilize our patent rights, which could potentially affect our
competitive position and prospects and adversely affect our business operations and financial
condition. Although we believe that we have conducted our patent prosecution in accordance
with a duty of candor and in good faith, the outcome following legal assertions of invalidity
and unenforceability during patent litigation is subject to uncertainty. In addition, competitors
or other third parties may challenge, infringe or misappropriate our patents and other
intellectual property rights. To counter infringement or unauthorized use, we may be required
to file infringement claims, which can be expensive and time consuming. In any infringement
proceeding, a court or governmental authority may decide that a patent of ours is not valid or
is unenforceable, or may refuse to stop the other party from using the technology at issue on
the grounds that our patents do not cover the technology in question.
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Even if we establish infringement, the court may decide not to grant an injunction against
further infringing activity and instead award only monetary damages, which may not be an
adequate remedy. Enforcing our intellectual property rights against third parties may also cause
such third parties to file other counterclaims against us, which could be costly to defend and
could require us to pay substantial damages. In addition, if the breadth or strength of protection
provided by our patents and other intellectual property rights is threatened, it could dissuade
companies from collaborating with us to license, develop, or commercialize our current or
future drug candidates. Any loss of intellectual property protection could have a material
adverse impact on one or more of our drug candidates and our business.
On the other hand, we cannot guarantee that our drug candidates or the sale or use of our
future products do not and will not in the future infringe, misappropriate or otherwise violate
third-party patents or other intellectual property rights. Third parties could allege that we are
infringing their patent rights or that we have misappropriated their trade secrets, or that we are
otherwise violating their intellectual property rights, whether with respect to the manner in
which we have conducted our research, or with respect to the use or manufacture of the
compounds we have developed or are developing.
It is also possible that we failed to identify, or may in the future fail to identify, relevant
patents or patent applications held by third parties that cover our drug candidates. Publication
of discoveries in the scientific or patent literature often lags behind actual discoveries.
Therefore, we cannot be certain that we were the first to invent, or the first to file patent
applications on, our drug candidates or for their uses, or that our drug candidates will not
infringe patents that are currently issued or that are issued in the future. In the event that a third
party has also filed a patent application covering one of our drug candidates or a similar
invention, our patent application may be regarded as a competing application and may not be
approved in the end. Additionally, pending patent applications that have been published can,
subject to certain limitations, be later amended in a manner that could cover our products or
their use.
If a third party were to assert claims of patent infringement against us, even if we believe
such third-party claims are without merit, a court of competent jurisdiction could hold that
these third-party patents are valid, enforceable and infringed, and the holders of any such
patents may be able to block our ability to commercialize the applicable product unless we
obtained a license under the applicable patents, or until such patents expire or are finally
determined to be invalid or unenforceable. Similarly, if any third-party patents were held by a
court of competent jurisdiction to cover aspects of our compositions, formulations, or methods
of treatment, prevention, or use, the holders of any such patents may be able to block our
ability to develop and commercialize the applicable product unless we obtained a license or
until such patent expires or is finally determined to be invalid or unenforceable. In addition,
defending such claims would cause us to incur substantial expenses and could cause us to pay
substantial damages, if we are found to be infringing a third party’s patent rights. These
damages potentially include increased damages and attorneys’ fees if we are found to have
infringed such rights willfully.
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In order to avoid or settle potential claims with respect to any patent or other intellectual
property rights of third parties, we may choose or be required to seek a license from a third
party and be required to pay license fees or royalties or both, which could be substantial. These
licenses may not be available on acceptable terms, or at all. Even if we were able to obtain a
license, the rights may be nonexclusive, which could result in our competitors gaining access
to the same intellectual property. Ultimately, we could be prevented from commercializing a
drug candidate, or be forced, by court order or otherwise, to modify or cease some or all aspects
of our business operations, if, as a result of actual or threatened patent or other intellectual
property claims, we are unable to enter into licenses on acceptable terms. Further, we could be
found liable for significant monetary damages as a result of claims of intellectual property
infringement.
An adverse result in any litigation proceedings could put one or more of our intellectual
property rights at risk of being invalidated or interpreted narrowly. Even if successful,
litigation may result in substantial costs and distraction of our management and other
employees. Furthermore, because of the substantial amount of discovery required in connection
with intellectual property litigation, there is a risk that some of our confidential information
could be compromised by disclosure during this type of litigation. In addition, there could be
public announcements of the results of hearings, motions or other interim proceedings or
developments. If the public, securities analysts or investors perceive these results to be
negative, or perceive that the presence or continuation of these cases creates a level of
uncertainty regarding our ability to increase or sustain products sales, it could have a
substantial adverse effect on the price of our Shares. There is no assurance that our drug
candidates will not be subject to the same risks.
If we are unable to obtain and maintain adequate patent and other intellectual property
protection for our drug candidates throughout the world, or if the scope of such
intellectual property rights obtained is not sufficiently broad, third parties could develop
and commercialize products and technologies similar or identical to ours and compete
directly against us, and our ability to successfully commercialize our drug candidates may
be adversely affected.
Our commercial success depends, to a certain extent, on our ability to protect our
proprietary technology and drug candidates from competition by obtaining, maintaining,
defending and enforcing our intellectual property rights, including patent rights. We seek to
protect the drug candidates and technology that we consider commercially important primarily
by filing patent applications in China, the U.S. and other countries or regions, relying on trade
secrets or pharmaceutical regulatory protection or employing a combination of these methods.
As of the Latest Practicable Date, we owned (i) four issued patents in China, (ii) six issued
patents in the U.S., (iii) three issued patents in other jurisdictions, and (iv) 160 patent
applications, including 40 in China, eight in the U.S., 19 under the PCT, nine in Europe, and
84 in other jurisdictions. See “Business — Intellectual Property” for details. This process is
expensive and time-consuming, and we or our business partners may not be able to file and
prosecute all necessary or desirable patent applications and secure other intellectual property
protection in all jurisdictions in a timely manner. It is also possible that we or our business
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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.
The patent position of biopharmaceutical companies generally involves complex legal
and factual questions, and can be frequently litigated. As a result, the issuance, scope, validity,
enforceability and commercial value of our patent rights are highly uncertain. Our current and
future patent applications may not be granted with approvals that effectively prevent third
parties from commercializing competitive technologies and drug candidates. The patent
examination process may require us or our business partners to narrow the scope of our or our
business partners’ current and future patent applications, which may then limit the scope of
patent protection that could be obtained. There can be no assurance that all of the potentially
relevant prior art relating to our patents and patent applications has been found. If such prior
art exists, it can invalidate a patent or prevent a patent application from being issued as a
patent. Moreover, if there are material defects in the form or preparation of our patents or
patent applications, such patents or applications may be invalid and unenforceable.
Even if patents are issued on these applications, there can be no assurance that a third
party will not challenge their validity, enforceability, or scope, which may result in the patent
claims being narrowed or invalidated, or that we will obtain sufficient claim scope in those
patents to prevent a third party from competing successfully with our drug candidates, or that
we may not be successful in preventing unfair competition by third parties throughout the
world. We or our business partners may become involved in interference, inter partes review,
post-grant review, ex parte reexamination, derivation, opposition or similar other proceedings
challenging our patent rights or the patent rights of others. An adverse determination in any
such proceeding could reduce the scope of, or invalidate, our patent rights, allow third parties
to commercialize our technology or drug candidates and compete directly with us, or result in
our inability to manufacture or commercialize drug candidates without infringing third-party
patent rights. Thus, even if our patent applications issue as patents, they may not issue in a
form that will provide us with any meaningful protection, prevent competitors from competing
with us or otherwise provide us with any competitive advantage.
The issuance of a patent is not conclusive as to its scope, validity or enforceability, and
our owned and licensed patents may be challenged in the courts or patent offices in any
jurisdictions. Such challenges may result in patent claims being narrowed, invalidated or held
unenforceable, which could limit our ability to stop or prevent us from stopping others from
using or commercializing similar or identical technology and drug candidates, or limit the
duration of the patent protection of our technology and drug candidates. As a result, our patent
portfolio may not provide us with sufficient rights to exclude others from commercializing
drug candidates similar or identical to ours. Our competitors may also be able to circumvent
our patent issuance by developing similar or alternative technologies or drug candidates in a
non-infringing manner.
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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. 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.
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 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.
Patent protection depends on compliance with various procedural, regulatory and other
requirements, and our patent protection could be reduced or eliminated for non-
compliance with these requirements.
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 authorities over the lifetime of a patent. The CNIPA, the
USPTO and other applicable patent authorities require compliance with a number of
procedural, documentary, fee payment, and other similar provisions during the patent
application process. While an inadvertent failure to make payment of such fees or to comply
with such provisions 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 such non-compliance will
result in the abandonment or lapse of the patent or patent application, and the 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, but not limited to
failure to respond to official actions within prescribed time limits, and non-payment of fees and
failure to properly legalize and submit formal documents within prescribed time limits. If we
or our collaboration partners fail to maintain the patents and patent applications covering our
drug candidates or if we or our collaboration partners otherwise allow our patents or patent
applications to be abandoned or lapse, our competitors might be able to enter the market, which
would hurt our competitive position and could impair our ability to successfully commercialize
our drug candidates in any indication for which they are approved. In addition, according to
the Patent Law of the PRC () (the “ PRC Patent Law ”) and related
regulations, we and our collaboration partners shall file the patent license agreements with the
CNIPA within three months after the effective date thereof, otherwise we may lose our
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exclusive right to use our in-licensed patents if the licensor grants a bona fide third party a right
to use the patent. Before such filings become effective, we may not be able to protect ourselves
against challenges brought by bona fide third parties to whom the licensors may, for any
reason, grant a right to use the same patents we have in-licensed.
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.
Lack of protection under the applicable patent linkage and patent term extension laws
and regulations could increase the risk of early generic competition.
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 from the date of application 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, including biosimilar medications.
Given the amount of time required for the development, testing and regulatory review of
new drug candidates, patents protecting such drug candidates could expire before or shortly
after such drug candidates are commercialized. As a result, our patents and patent applications
may not provide us with sufficient rights to exclude others from commercializing products
similar or identical to ours. 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. In addition, 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.
Even if we believe that we are eligible for certain patent term extensions, there can be no
assurance that the applicable authorities, including the FDA and the USPTO in the U.S., and
any equivalent regulatory authority in other countries, 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 request. For example, depending
upon the timing, duration and specifics of any FDA marketing approval of any drug candidates
we may develop, one or more of our U.S. patents may be eligible for limited patent term
extension under the Drug Price Competition and Patent Term Restoration Action of 1984, or
Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent extension term
of up to five years as compensation for the patent term lost during the FDA regulatory review
process. A patent term extension cannot extend the remaining term of a patent beyond a total
of 14 years from the date of product approval, only one patent may be extended, and only those
claims covering the approved drug, a method for using it, or a method for manufacturing it,
may be extended. Similarly, 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,
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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.
Moreover, the length of the extension could be less than we request. If we are unable to
obtain patent term extension or the term of any such extension is less than we request, the
period during which we can enforce our patent rights for that product will be shortened and our
competitors may obtain approval to market competing products sooner than we expect. Also,
the scope of our right to exclude during any patent term extension period may be limited or
may not cover a competitor’s product or product use. As a result, our revenue from applicable
drug candidates, if approved, could be reduced, possibly materially.
Manufacturers of generic or biosimilar drugs may challenge the scope, validity, or
enforceability of our patents in court or before a patent office, and we may not be successful
in enforcing or defending those intellectual property rights and, as a result, may not be able to
develop or market the relevant product exclusively, which would have a material adverse effect
on any potential sales of that product. Upon the expiration of our issued patents or patents that
may issue from our pending 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. On the other hand, if we launch our drug candidates prior to the expiration of patents
for any competing products, we may face potential claims for patent infringement.
If our trademarks and trade names are not adequately protected, we may not be able to
build name recognition in our markets of interest and our competitive position may be
adversely affected.
We own a number of trademarks in China and other jurisdictions. Our trademarks or trade
names may be challenged, infringed, circumvented or declared generic or determined to be
infringing on other marks, and may not be registered in all the necessary or desirable
jurisdictions and categories in which we intend to sell our future products or provide our future
services. Our trademarks may not be approved by one or more governmental trademark offices
or may not be approved for use on our products or services by regulatory authorities, such as
the FDA. We may not be able to protect our rights to these trademarks and trade names or may
be forced to stop using these names, which we need for name recognition by 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.
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If we are unable to establish name recognition based on our trademarks and trade names,
we may not be able to compete effectively and our business may be adversely affected. In the
future, we may license our trademarks and trade names to third parties, such as business
partners and collaborators. Though these license agreements may provide guidelines for how
our trademarks and trade names may be used, a breach of these agreements or misuse of our
trademarks and trade names by our licensees may jeopardize our rights in or diminish the
goodwill associated with our trademarks and trade names.
If we are unable to protect the confidentiality of our trade secrets, our business and
competitive position would be harmed. We also may be subject to claims that our
employees, consultants, or advisers have wrongfully used or disclosed alleged trade
secrets of their former employers or claims asserting ownership of what we regard as our
own intellectual property.
In addition to our issued patents and pending patent applications, we rely on trade secret
and confidential information, including unpatented know-how, technology and other
proprietary information, to maintain our competitive position and to protect our drug
candidates. If we rely on third parties to manufacture or commercialize our current or any
future drug candidates, or if we collaborate with third parties for the development of our
current or any future drug candidates, we must, at times, share trade secrets with them, which
increases the possibility that a competitor will discover them or that our trade secrets will be
misappropriated or disclosed. We seek to protect our trade secrets and confidential information,
in part, by entering into non-disclosure, confidentiality and similar agreements with parties that
have access to them, such as our employees, corporate collaborators, outside scientific
collaborators, sponsored researchers, CDMOs, consultants, advisers and other third parties.
Any of these parties may breach such agreements and disclose our proprietary information, and
we may not be able to obtain adequate remedies for such breaches. Moreover, 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.
Despite our efforts to protect our trade secrets, our competitors may discover our trade
secrets, either through breach of our agreements with third parties, independent development
or publication of information by any third-party collaborators. Given that our proprietary
position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our
trade secrets or other unauthorized use or disclosure could have an adverse effect on our
business and results of operations. 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 we are unable to prevent unauthorized material disclosure of our
intellectual property to third parties, or misappropriation of our intellectual property by third
parties, we will not be able to establish or maintain a competitive advantage in our market,
which could materially and adversely affect our business, financial condition, and results of
operations. 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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Furthermore, many of our employees, consultants, and advisers, including our senior
management, were previously employed at other biotechnology or pharmaceutical companies,
including our competitors or potential competitors. Some of these employees, consultants, and
advisers, including members of our senior management, executed proprietary rights, non-
disclosure and non-competition agreements in connection with such previous employment.
Although we try to ensure that our employees do not wrongfully use the proprietary
information or know-how of others in their work for us, we may be subject to claims that we
or these employees have used or disclosed intellectual property, including trade secrets or other
proprietary information, of any such individual’s former employer. 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 our management. See also “—
Risks Relating to Intellectual Property Rights — We may from time to time be involved in legal
proceedings and disputes to protect or enforce our intellectual property rights, or defend
against infringement and other claims alleged by third parties, which could be expensive, time
consuming and unsuccessful.”
In addition, while we typically require our employees, consultants 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. Further, the
assignment of intellectual property rights may not be self-executing, or the assignment
agreements may be breached, each of which may result in claims by or against us related to the
ownership of such intellectual property.
Litigation may be necessary to defend against these claims. If we fail in prosecuting or
defending any such claims, in addition to paying monetary damages, we may lose valuable
intellectual property rights. Even if we are successful in prosecuting or defending against such
claims, litigation could result in substantial costs, be a distraction to our management and
scientific personnel and have a material adverse effect on our business, financial condition,
results of operations and prospects.
Intellectual property and other laws and regulations are subject to change, which could
diminish the value of our intellectual property in general, thereby impairing our ability
to protect our current and any future drug candidates.
Obtaining and enforcing patents in the biopharmaceutical industry involve a high degree
of technological and legal complexity. Therefore, obtaining and enforcing biopharmaceutical
patents is costly, time consuming and inherently uncertain. Changes in either the patent laws
or in the interpretations of patent laws in China, the United States and other countries may
diminish the value of our intellectual property and may increase the uncertainties and costs
surrounding the prosecution of patent applications and the enforcement or defense of issued
patents. We cannot predict the breadth of claims that may be allowed or enforced in our future
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patents or in third-party patents. In addition, there are periodic proposals for changes to the
patent laws in China, the United States and other countries that, if adopted, could impact our
ability to enforce our proprietary technology.
In China, intellectual property laws are constantly evolving, with efforts being made to
improve intellectual property protection in the PRC. For example, on October 17, 2020, the
Standing Committee of the National People’s Congress of the PRC (the “ SCNPC ”)
promulgated the Amendment to the PRC Patent Law effective from June 1, 2021, which
provides that, among others, the patentee of an invention patent relating to the new drug that
has been granted the marketing authorization in the PRC is entitled to request the patent
administration department under the State Council to grant a patent term extension of up to five
years, in order to compensate the time required for the regulatory evaluation and approval for
the commercialization of such a new drug; provided that, the total remaining patent term of
such a new drug approved for commercialization shall not exceed fourteen (14) years after such
approval. As a result, the terms of our PRC patents may be eligible for extension and allow us
to extend patent protection of our products, and the terms of the patents owned by third parties
may also be extended, which may in turn affect our ability to commercialize our products
candidates, if and when approved, without facing infringement risks. The length of any such
patent term extension is uncertain. If we are required to delay commercialization for an
extended period of time, technological advances may develop and new competitor products
may be launched, which may render our product non-competitive. We also cannot guarantee
that other changes to PRC intellectual property laws would not have a negative impact on our
intellectual property protection.
Evolving judicial interpretation of patent law could also adversely affect our business.
The U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit have issued
numerous precedential opinions in recent years narrowing the scope of patent protection
available in certain circumstances or weakening 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. Depending on future actions by the U.S. Congress, the U.S. federal
courts, the USPTO or similar authorities in foreign jurisdictions, the laws and regulations
governing patents could change in unpredictable ways that would weaken our ability to obtain
new patents or to enforce or defend patents that we have licensed or that we might own or
license in the future.
Similarly, changes in patent law and regulations in other countries or jurisdictions or
changes in the governmental bodies that enforce them or changes in how the relevant
governmental authority enforces patent laws or regulations may weaken our ability to obtain
new patents or to enforce our current and future owned and licensed patents.
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Intellectual property rights do not necessarily protect us from all potential threats to our
competitive advantages.
The degree of future protection afforded by our intellectual property rights is uncertain
because intellectual property rights have limitations, and may not adequately protect our
business nor permit us to maintain our competitive advantage. The following examples are
illustrative:
 others may be able to make drug candidates that are the same as or similar to our
drug candidates but that are not covered by the claims of the patents that we own or
may have exclusively licensed;
 others may independently develop similar or alternative technologies or duplicate
any of our technologies without infringing our intellectual property rights;
 third parties might conduct research and development activities in countries 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;
and
 we may not develop additional technologies that are patentable.
RISKS RELATING TO GOVERNMENT REGULATIONS
All material aspects of the research, development, manufacturing and commercialization
of biopharmaceutical products are heavily regulated. Any failure to comply with relevant
laws, regulations and industry standards or any adverse actions by the regulatory
authorities against us could negatively impact our reputation and our business, financial
condition, results of operations and prospects.
All jurisdictions in which we operate or intend to our business regulate the research,
development, manufacturing and commercialization of biopharmaceutical products in great
depth and detail. We intend to implement a global development strategy, with a focus on China
and the United States, the two largest pharmaceutical markets in the world. These jurisdictions
strictly regulate the pharmaceutical industry, and in doing so they employ a broad range of
strategies, including regulation of product development and approval, manufacturing, and
marketing, sales and distribution of products. Evolutions and differences in these regulatory
regimes could lead to an increased and costly regulatory compliance burden.
We are required to obtained and maintain certain licenses and permits for conducting our
business. The process of obtaining regulatory approvals and compliance with appropriate laws,
regulations and guidance requires the expenditure of substantial time and financial resources.
If any regulatory authorities consider that we were operating without the requisite approvals,
licenses or permits or promulgates new laws and regulations that require additional approvals
or licenses or imposes additional restrictions on the operation of any part of our business, it has
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the power, among other things, to levy fines, confiscate our income, revoke our business
licenses, and require us to discontinue our relevant business or impose restrictions on the
affected portion of our business. In particular, failure to comply with the applicable
requirements at any time during the product development process and approval process, or
after approval, may subject an applicant to administrative or judicial sanctions. These sanctions
could include refusal to approve pending applications, withdrawal of an approval, license
revocation; clinical hold, voluntary or mandatory product recalls, product seizures; total or
partial suspension of production or distribution, injunctions, fines, refusals of government
contracts, restitution and disgorgement, or other civil or criminal penalties. Failure to comply
with these laws, regulations and guidance could have a material and adverse effect on our
business and prospects.
In many countries or regions where a drug is intended to be ultimately sold, including
China and the U.S., the relevant government agencies and industry regulatory bodies impose
high standards on the efficacy of such drug, as well as strict rules, regulations and industry
standards on how we develop such drug. For example, we may need to obtain clearance from
the NMPA, the FDA or other regulatory authorities as part of an IND application to seek
authorization to begin clinical trials, and file an NDA, a BLA or other similar applications to
seek marketing approval. Any failure to comply with existing laws, regulations and industry
standards could result in fines or other punitive actions against us, the termination of ongoing
research and the disqualification of data for submission to regulatory authorities, or a ban on
the future sales of our drugs, each of which could have a material adverse impact on our
reputation, business, financial condition, results of operations and prospects. In addition, any
action against us for violation of the relevant laws, regulations or industry standards, even if
we successfully defend against it, could cause us to incur significant legal expenses, divert our
management’s attention from the operation of our business, and adversely affect our reputation
and financial results.
The regulatory approval processes of the NMPA, the FDA and other comparable
regulatory authorities are time-consuming and may evolve over time. If we are unable to
obtain without undue delay any regulatory approvals for our drug candidates in our
target markets, our business may be subject to actual or perceived harm.
Generally, approval from the NMPA and FDA take many years to obtain, following the
commencement of preclinical studies and clinical trials. In addition, 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.
Additional time, effort and expense may be required to bring our drug candidates, upon
regulatory approval, to the international markets in compliance with different regulatory
processes.
Our drug candidates could fail to receive the regulatory approval of the NMPA, the FDA
or a comparable regulatory authority for many reasons, including, without limitation:
 disagreement with the design or implementation of our clinical trials;
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 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;
 failure to demonstrate that a drug candidate’s clinical and other benefits outweigh its
safety risks;
 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, a BLA or other submissions or to obtain
regulatory approval;
 failure of our drug candidates to pass cGMP , inspections during the regulatory
review process or across the production cycle of our drug;
 failure of our clinical sites to pass audits carried out by the NMPA, the FDA or
comparable regulatory authorities, resulting in a potential invalidation of our
research data;
 findings by the NMPA, the FDA or comparable regulatory authorities of deficiencies
related to the manufacturing of our products;
 changes in approval policies or regulations that render our preclinical and clinical
data insufficient for approval; and
 failure of our clinical trial process to keep up with any scientific or technological
advancements required by approval policies or regulations.
The NMPA, the FDA 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.
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If we are unable to obtain or maintain approval from the NMPA, the FDA and other
comparable regulatory authorities for our drug candidates to be eligible for an expedited
registration pathway as innovative or breakthrough therapy, the time and cost we incur
to obtain regulatory approvals may increase.
The NMPA, the FDA and the comparable regulatory authorities in other jurisdictions may
have implemented expedited review programs for drug candidates, among others, which are
innovative drug applications, or which treat a serious or life-threatening condition and provide
meaningful therapeutic benefit over available therapies. The NMPA ’s Breakthrough Therapy
Designation, for example, is intended to facilitate and expedite the development and review of
an investigational drug to treat a serious disease or condition when preliminary clinical
evidence indicates that the drug has demonstrated substantial improvement over current
therapies. Similarly, the FDA may facilitate the development and expedite the review of
pharmaceutical products that are intended for the treatment of a serious or life-threatening
condition for which there is no effective treatment and which demonstrate the potential to
address medical need for the condition.
To date, three of our clinical-stage assets, including our Core Products DB-1303 and
DB-1311 and key product DB-1305, have received Fast Track Designation from the FDA, and
DB-1303 has received Breakthrough Therapy Designations from both the FDA and NMPA. For
details, see “Business — Our Pipeline.” There can be no assurance, however, that the
regulatory authorities will consider granting Fast Track Designation, Breakthrough Therapy
Designation or other expedited review programs for our other or future drug candidates, or that
we will decide to pursue or submit any applications for accelerated approvals or any other form
of expedited development, review or approvals. Similarly, there can be no assurance that, after
receiving feedback from the regulatory authorities, we will continue to pursue or apply for
accelerated approvals or any other form of expedited development, review or approvals, even
if we initially decide to do so. Furthermore, there can be no assurance that such a submission
or application will be accepted for filing, or that any expedited development, review or
approvals will be granted on a timely basis, or at all. In addition, expedited registration
pathways may contain certain conditions related to use restrictions for certain patient
populations, warnings, precautions or contraindications, or may be subject to burdensome
post-approval study or risk management requirements. Any failure to obtain accelerated
approvals or any other form of expedited development, review or approvals for our drug
candidates and/or any future changes to current polices and approvals with respect to the
expedited registration pathways of our drug candidates could result in a longer period of time
prior to the commercialization of such drug candidate, an increase in the development expenses
for such drug candidate and an adverse impact on our competitive position in the market.
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Even if we receive regulatory approval for our drug candidates, we will be subject to
ongoing regulatory obligations and continued regulatory review, which may result in
significant additional expenses. We may be subject to penalties and other negative
consequences if we fail to comply with the applicable regulatory requirements.
If the NMPA, the FDA or other comparable regulatory authorities approve any of our drug
candidates, the manufacturing processes, labeling, packaging, distribution, adverse event
reporting, storage, advertising, promotion and record-keeping for the drug will be subject to
extensive and ongoing regulatory requirements on pharmacovigilance. These requirements
include submissions of safety and other post-marketing information and reports, registration,
random quality control testing, adherence to any chemistry, manufacturing, and controls
(“CMC”), variations, continued compliance with current cGMPs, and GCPs and potential
post-approval studies for the purposes of license renewal.
Any regulatory approvals that we receive for our drug candidates may also be subject to
limitations on the approved indicated uses for which the drug may be marketed or to other
conditions of approval, including requirements for potentially costly post-marketing studies,
such as studies for the surveillance and monitoring of the safety and efficacy of the drug.
In addition, once a drug is approved by the NMPA, the FDA or other comparable
regulatory authorities for marketing, it is possible that there could be a subsequent discovery
of previously unknown problems with the drug, including problems with third-party
manufacturers or manufacturing processes, or failure to comply with regulatory requirements.
If any of the foregoing occurs with respect to our drug products, it may result in, among other
things:
 restrictions on the marketing or manufacturing of the drug, withdrawal of the drug
from the market, or voluntary or mandatory recalls;
 fines, warning letters or holds on our clinical trials;
 refusal by the NMPA, the FDA or comparable regulatory authorities to approve
pending applications or supplements to approved applications filed by us, or
suspension or revocation of drug license approvals;
 refusal by the NMPA, the FDA or comparable regulatory authorities to accept any
of our other IND approvals and NDAs/BLAs;
 drug seizure or detention, or refusal to permit the import or export of drugs; and
 injunctions or the imposition of civil, administrative or criminal penalties.
Moreover, regulations or policies may change or additional government regulations may
be finalized that could prevent, limit or delay regulatory approval of our drug candidates.
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Any government investigation of alleged violations of law could require us to expend
significant time and resources and could generate negative publicity. If we are not able to
maintain regulatory compliance, we may lose the regulatory approvals that we have already
obtained and may not achieve or sustain profitability, which in turn could significantly harm
our business, financial condition and pipeline of biopharmaceutical products.
Changes in laws and regulations relating to the biopharmaceutical industry, including the
ongoing healthcare reform in China, may result in additional compliance risks and costs.
In China, the U.S. and other jurisdictions, there have been, and we expect there will
continue to be, a number of legislative and regulatory changes relating to the
biopharmaceutical industry and the healthcare system, including cost-containment measures
that may reduce or limit coverage and reimbursement for newly approved drugs and affect our
ability to profitably sell any drug candidates for which we obtain marketing approval. See also
“— Risks Relating to the Manufacturing and Commercialization of Our Drug Candidates —
Even if we are able to commercialize any approved drug candidates, reimbursement may be
limited or unavailable in certain market segments for our drug candidates, and we may be
subject to unfavorable pricing regulations, which could harm our business.”
In particular, the PRC government has enacted a series of new laws and regulations in
recent years aimed at improving the affordability and deterring potential over-use of oncology
drugs. In December 2020, for instance, the National Health Commission (the “ NHC”) released
the Notice on the Temporary Measures Regulating the Clinical Use of Oncology Drugs ( ᗫ
ج(༊Б)), followed by more detailed guidance
announced in its Measurement Criteria for the Reasonable Clinical Use of Oncology Drugs
(2021 V ersion) (ᅺ(2021وin June 2021 (“ Oncology
Drug Guidance ”), according to which several factors will be considered to evaluate whether
the oncology drugs, especially “restricted class drugs,” are under reasonable use by the medical
institutions, in terms of usage rate and amount, among other criteria. The Oncology Drug
Guidance sets out to designate anti-tumor drugs as “restricted class drugs” if they, among other
characteristics, exhibit a poor safety profile, require sophisticated clinical administration, new
to the market or prohibitively priced. If our oncology drug candidates are categorized as
“restricted class drugs” after commercialization, we may face a decreased demand from the
medical institutions and patients, which may adversely affect the commercialization and
marketing of such drug candidates. These new laws, regulations and healthcare reform
measures and others which may be adopted in the future may result in more rigorous
prescription and coverage criteria, new reimbursement methods and additional downward
pressure on drug prices.
Although none of our drug candidates had been commercialized as of the Latest
Practicable Date, these legislative trends and regulatory measures can potentially affect the
sales, profitability and prospects of our drug candidates in the future. Moreover, because these
laws and regulations are subject to varying interpretations, their application in practice may
evolve over time as new guidance becomes available. This evolution may result in continuing
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uncertainty regarding compliance matters and additional costs necessitated by ongoing
revisions to our disclosure and governance practices. If we fail to address and comply with
these laws and regulations and any subsequent changes, we may be subject to penalty and our
business may be harmed.
If we or our CROs, CDMOs and other business partners fail to comply with
environmental, health and safety laws and regulations, we could become subject to fines
or penalties and other negative consequences that could have a material and adverse
effect on the success of our business.
We and certain third parties we work with, such as our CROs, CDMOs and business
partners, 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. We generally contract with third parties for the
disposal of these materials and wastes and we cannot guarantee our contractors could
continuously maintain their qualifications with regard to such disposal. We cannot eliminate
the risk of contamination or injury from these materials. In the event of contamination or injury
resulting from our use of hazardous materials, we could be held liable for any resulting
damages, and any liability could exceed our resources. We also could incur significant costs
associated with civil or criminal fines and penalties. We do not maintain insurance for
environmental liability or toxic tort claims that may be asserted against us in connection with
our storage, use or disposal of biological, hazardous or radioactive materials. We may also
incur liabilities due to injuries to our employees resulting from the use of or exposure to
hazardous materials, and we do not maintain insurance covering such potential liabilities.
In addition, we may be required to incur substantial costs to comply with current or future
environmental, health and safety laws and regulations. These current or future laws and
regulations may impair our research, development or production efforts. Failure to comply with
these laws and regulations also may result in substantial fines, penalties or other sanctions.
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 in China and other jurisdictions, which could expose us to
administrative sanctions, criminal sanctions, civil penalties, contractual damages,
reputational damage and diminished profits and future earnings.
Healthcare providers, doctors and others play a primary role in the recommendation and
prescription of any products for which we obtain regulatory approval. If we obtain the approval
for any of our drug candidates and begin commercializing our drugs in China in the future, our
operations may become subject to various PRC fraud and abuse laws, including the PRC
Anti-Unfair Competition Law () and PRC Criminal Law
(). These laws may impact, among others, our proposed sales,
marketing and education programs.
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Law enforcement authorities are increasingly focusing on enforcing these laws. Efforts to
ensure that our business arrangements with third parties are in compliance with applicable
healthcare laws and regulations will involve substantial costs. 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 and results of operations.
Furthermore, we are subject to anti-bribery laws in China 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 (the “ 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. See also “— Risks Relating to Our Operations — We may be unable to
detect, deter and prevent all instances of bribery, fraud or other misconduct committed by our
employees or third parties.”
As we expand our operations globally, we may also become subject to similar laws and
regulations from other jurisdictions. There are ambiguities as to what is required to comply
with any of these laws and regulations, and if we fail to comply with such requirements, we
could be subject to penalties and other negative consequences. If any of the physicians or other
third parties with whom we do business are found to be not in compliance with the applicable
laws and regulations, they may be subject to criminal, civil or administrative sanctions,
including exclusions from government funded healthcare programs, which may also adversely
affect our business.
We face regulation and potential liability related to privacy, data protection and
information security which may require significant resources and may adversely affect
our business, operations and financial performance.
We and the CROs we engage may routinely receive, collect, generate, store, process,
transmit and maintain medical data, treatment records and other personal details of subjects
enrolled in our clinical trials, along with other personal or potentially sensitive information. As
such, we are subject to the relevant local, state, national and international data protection and
privacy laws, directives, regulations and standards that apply to the collection, use, retention,
protection, disclosure, transfer and other processing of personal information in the various
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jurisdictions in which we operate and conduct our clinical trials, as well as contractual
obligations. These data protection and privacy law regimes continue to evolve and may result
in ever-increasing public scrutiny and escalating levels of enforcement and sanctions and
increased costs of compliance including, for example, substantial operational costs associated
with changes to our data processing practices. Failure to comply with any of these laws could
result in enforcement action against us, including and without limitation to fines, imprisonment
of company officials and public censure, claims for damages by customers and other affected
individuals, damage to our reputation and loss of goodwill, any of which could have a material
and adverse effect on our business, financial condition, and results of operations or prospects.
The personal information of patients or subjects which might be involved in our clinical
trials could be highly sensitive and we are subject to strict requirements under the applicable
privacy protection regulations in the relevant jurisdictions. While we have adopted security
policies and measures to protect our proprietary data and patients’ privacy, such policies and
measures might not satisfy all the requirements in every respect under the applicable laws and
regulations. Data leakage and abuse and other misconduct related to data and personal
information protection might not be completely avoided, due to hacking activities, human
error, employee misconduct or negligence or system breakdown, among other reasons. We also
cooperate with hospitals, CROs and other business partners, licensees, contractors and
consultants for our clinical trials and operations. Any leakage or abuse of patient data by our
third-party partners may be perceived by the patients as a result of our failure. Any failure or
perceived failure by us to prevent information security breaches or to comply with data/privacy
policies or data/privacy-related legal obligations, or any compromise of information security
that results in the unauthorized release or transfer of personal information or other patient data,
could cause our customers to lose trust in us and could expose us to legal claims.
We are subject to stringent data privacy and cybersecurity laws and policies, and we may
be restricted from transferring data abroad or using human genetic resources collected
within the PRC.
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 that 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 PRC 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 that the term “state secret” is not clearly defined, if and to the extent any data collected
or generated in connection with our R&D of drug candidates will be subject to the Scientific
Data Measures and any subsequent laws as required by the relevant government authorities,
there is no assurance 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.
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In addition, the Regulations of PRC on the Administration of Human Genetic Resources
(ʕശɛ͏΍ձ਷ɛᗳ፲ෂ༟๕၍ଣૢԷ) (the “ HGR Regulation ”), which was
promulgated on May 28, 2019 and further amended on March 10, 2024, stipulates that foreign
organizations, foreign individuals and the institutions established or actually controlled thereby
shall not collect or preserve China’s human genetic resources within the PRC, and shall not
provide China’s human genetic resources abroad. Where a foreign organization or an institution
established or actually controlled by a foreign organization or foreign individual needs to use
China’s human genetic resources to conduct scientific research activities, it shall comply with
the applicable laws, administrative regulations and relevant provisions in the PRC, and
cooperate with China’s scientific research institutions, universities, medical institutions and
enterprises provided therein. In this regard, utilization of China’s human genetic resources for
international cooperation in scientific research, as well as transporting China’s human genetic
resources materials abroad shall be subject to the approval of the administrative department for
health under the State Council. However, no approval is required in international clinical trial
cooperation using China’s human genetic resources at clinical institutions without export of
human genetic resource materials for obtaining the licensing for the listing of relevant drugs
and medical devices in the PRC market, provided that the type, quantity and usage of the
human genetic resources to be used shall be filed with the administrative department for health
under the State Council before conducting the clinical trials. If we are unable to obtain
necessary approvals, complete the filings or comply with the regulatory requirements in a
timely manner, or at all, our R&D of drug candidates may be hindered. Further, the Biosecurity
Law (), which was promulgated on October 17, 2020, became effective on
April 15, 2021, and amended on April 26, 2024, reaffirms the regulatory requirements
stipulated by the HGR Regulation while potentially increasing the administrative sanctions
where China’s human genetic resources are collected, preserved, exported or used in
international cooperation in violation of applicable laws. If the relevant government authorities
consider the transmission of our scientific data or usage of human genetic resources to be in
violation of the requirements under applicable PRC laws and regulations, we may be subject
to fines and other administrative penalties imposed by those government authorities.
The landscape of cybersecurity and data privacy and security laws is constantly evolving.
For example, on November 7, 2016, the SCNPC promulgated the Cybersecurity Law ( ၣഖ
), effective on June 1, 2017, which requires network operators to safeguard security
of the network and follow the principles of legitimacy in collecting and using personal
information. On June 10, 2021, the SCNPC promulgated the Data Security Law ( ᅰኽτΌ
), effective on September 1, 2021, which imposes data security and privacy protection
obligations on entities and individuals which carry out data activities, and introduces a data
classification and hierarchical protection system. On August 20, 2021, the SCNPC promulgated
the Personal Information Protection Law (), effective on November 1,
2021, which further detailed the general rules and principles on personal information
processing and further increased the potential liability of personal information processor. See
“Regulatory Overview — Regulations on Information Security and Data Protection.”
Complying with new laws and regulations could substantially increase the costs or require us
to change our business practices in a manner materially adverse to our business. Additionally,
to the extent we are found by the PRC regulators to be not in compliance with these laws and
requirements, we may be subject to fines, regulatory orders to suspend our operations or other
regulatory and disciplinary sanctions.
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On December 28, 2021, the Cyberspace Administration of China (the “ CAC”), together
with other relevant administrative departments, jointly promulgated the revised Cybersecurity
Review Measures () with effect from February 15, 2022, according to
which, the purchase of network products and services by a critical information infrastructure
operator (the “ CIIO ”) or the data processing activities of a network platform operator that
affect or may affect national security will be subject to a cybersecurity review. In addition, an
online platform operator who possesses personal information of over one million users and
intends for listing in a foreign country ( ਷̮ɪ̹) must be subject to the cybersecurity review.
However, there has been no further explanation or interpretation for “foreign listing” or “affect
or may affect national security” under the aforementioned regulation. In addition, we cannot
rule out the possibility that the relevant government authorities may conduct cybersecurity
review on us according to the Cybersecurity Review Measures. If a cybersecurity review for
any of our activities is required, we will actively cooperate with the CAC to conduct such
cybersecurity review. Any failure to obtain such approval or clearance from the regulatory
authorities could materially constrain our liquidity and have a material adverse impact on our
business operations and financial results, especially if we need additional capital or financing.
On September 30, 2024, the Administration Regulations on Cyber Data Security ( ၣഖ
ᅰኽτΌ၍ଣૢԷ) (the “ Data Security Regulations ”) was promulgated by the State
Council, which came into effect on January 1, 2025. The Data Security Regulations reiterate
and refine the general regulations for cyber data processing activities, rules of personal
information protection, important data security protection, cyber data cross-border transfer
management, and the responsibilities of online platform service providers. In particular, the
Data Security Regulations provide that cyber data processors whose cyber data processing
activities affect or may affect national security shall be subject to national security review in
accordance with the relevant regulations. However, the Data Security Regulations provide no
further explanation or interpretation for the criteria on determining the risks that “affect or may
affect national security”. Additionally, since the Data Security Regulations are still relatively
new, the interpretation and implementation of these regulations may further evolve and
develop.
Moreover, the regulatory framework on cross-border transfer of personal information and
data worldwide is rapidly evolving and is likely to remain uncertain due to lack of clear
explanation and instruction on enforcement. For example, in recent years, China has
promulgated several laws and regulations on cross-border data transfer, including but not
limited to the Data Security Law, the Personal Information Protection Law, the Measures for
the Security Assessment of Cross-border Data Transfer (), the
Measures for the Administration of Standard Contractual Clauses for the Cross-Border Transfer
of Personal Information () and the Provisions on Promoting
and Regulating Cross-Border Data Flows (). These
regulations have provided that, amongst others, CIIO that provides any personal information
or important data to an overseas recipient, and other data processors that provides any
important data, sensitive personal information or certain amount of non-sensitive personal
information to an overseas recipient shall be subject to security assessment, standard contract
filing or personal information protection certification for outbound data transfer activities,
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unless otherwise provided under the relevant laws and regulations. We cannot guarantee if
these rules or regulations promulgated will impose additional compliance requirements,
including any approval, filing and other administrative measures thereunder, and we cannot
guarantee that the measures we have taken or will take in the future will always be effective
or fully satisfy the relevant regulatory requirements under the relevant laws and regulations,
including obtaining such approval, filing and other administrative measures in a timely manner,
or at all.
Changes in political and economic policies, as well as the interpretation and enforcement
of laws, rules and regulations, may affect our business, financial condition, results of
operations and prospects.
A substantial portion of our operations are based in the PRC, our business, financial
condition, results of operations and prospects may be affected by economic, political, social
and legal developments in China. The Chinese government has implemented various measures
to encourage economic growth and guide the allocation of resources; however, we cannot
guarantee the extent to which our business operations will be able to benefit from such
measures, if at all. In addition, laws, rules and regulations may also be amended from time to
time, and the application, interpretation and enforcement of such evolving laws, rules and
regulations may affect our business operations. Any of the foregoing may have a material and
adverse effect on our business, financial condition, results of operations and prospects.
We may be classified as a “PRC resident enterprise” for PRC enterprise income tax
purposes and our income may be subject to PRC tax under the relevant PRC laws.
Under the Corporate Income Tax Law of the PRC (the “ CIT Law ”), an enterprise
established outside of China with “de facto management bodies” within China is considered a
“resident enterprise,” meaning that it will be treated in a manner similar to a Chinese enterprise
for PRC enterprise income tax purposes. Under the Circular of the State Taxation
Administration (the “ STA”) on Issues Concerning the Identification of Chinese-Controlled
Enterprises Registered Overseas as Resident Enterprises on the Basis of Their De Facto
Management Bodies (֛
) issued by the STA on April 22, 2009 and partially abolished in
December 2017, or Circular 82, provides certain specific criteria for determining whether the
“de facto management body” of a PRC-controlled enterprise that is incorporated offshore.
Although Circular 82 only applies to offshore enterprises controlled by PRC enterprises or
PRC enterprise groups, not those controlled by foreigners like us as of the Latest Practicable
Date, the criteria set forth in the Circular 82 may reflect the STA ’s general position on how the
“de facto management body” test should be applied in determining the tax resident status of all
offshore enterprises. Under Circular 82, an offshore enterprise controlled by a PRC enterprise
or a PRC enterprise group will be regarded as a PRC tax resident by virtue of having its “de
facto management body” in China and will be subject to PRC enterprise income tax on its
global income only if all of the following conditions are met: (i) the primary location of the
day-to-day operational management and their work location is in the PRC; (ii) decisions
relating to the enterprise’s financial and human resources matters are made or are subject to
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approval by organizations or personnel in the PRC; (iii) the enterprise’s primary assets,
accounting books and records, company seals, and board and shareholder resolutions, are
located or maintained in the PRC; and (iv) at least 50% of voting board members or senior
executives habitually reside in the PRC. On July 27, 2011, the STA issued Administrative
Measures of Enterprise Income Tax of Chinese-Controlled Offshore Incorporated Resident
Enterprises (Trial) (ج(༊Б)), or Bulletin 45,
which became effective on September 1, 2011 and as amended in 2015, 2016 and 2018, to
provide further guidance on the implementation of Circular 82. Bulletin 45 clarifies certain
issues related to determining PRC resident enterprise status, including which the competent tax
authorities are responsible for determining offshore incorporated PRC resident enterprise
status, as well as post-determination administration.
Despite the foregoing, the STA may take the view that the determining criteria set forth
in Circular 82 and Bulletin 45 reflect the general position on how the “de facto management
body” test should be applied in determining the tax resident status of all offshore enterprises.
Additional implementing regulations or guidance may be issued determining that we or any of
our subsidiaries incorporated out of the PRC is a “resident enterprise” for PRC enterprise
income tax purposes. If the PRC tax authorities determine that we or any of our subsidiaries
incorporated out of the PRC is a resident enterprise for PRC enterprise income tax purposes,
a number of unfavorable PRC tax consequences could follow. First, we and our non-PRC
subsidiaries may be subject to enterprise income tax at a rate of 25% on our worldwide taxable
income, as well as to PRC enterprise income tax reporting obligations. Second, although under
the CIT Law and its implementing rules, Circular 82 and Bulletin 45 dividends paid by a PRC
tax resident enterprise to an offshore incorporated PRC tax resident enterprise controlled by
PRC enterprise would qualify as tax-exempted income, we cannot assure that dividends paid
by our PRC subsidiaries to us will not be subject to any withholding tax. Finally, the CIT Law
and its implementing rules issued by PRC tax authorities provide that dividends paid by us to
our non-PRC shareholders and, while less clear, capital gains recognized by them with respect
to the sale of our Shares may be subject to tax of 10% for non-PRC resident enterprise
shareholders and 20% for non-PRC resident individual shareholders. In the case of dividend
payments, such PRC tax may be withheld at source.
Governmental regulations on currency exchange may affect us.
The convertibility of Renminbi into foreign currencies and, in certain cases, the
remittance of currency into and out of China are subject to PRC foreign exchange regulations.
Under existing PRC foreign exchange regulations, payments of current account items, such as
profit distributions and trade and service-related foreign exchange transactions, can be made
in foreign currencies without prior approval from SAFE by complying with certain procedural
requirements. However, approval from or registration with appropriate governmental
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.
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In July 2014, SAFE promulgated the Circular of the SAFE on Foreign Exchange
Administration of Equity Financing and Round-Trip Investments by Domestic Residents via
Special Purpose V ehicles (ڏ
)( “ Circular 37 ”). Circular 37 requires PRC residents
(including PRC individuals and PRC corporate entities as well as foreign individuals with a
habitual residence in China due to economic interests) to register with SAFE or its local
branches in connection with their direct or indirect offshore investment activities. Circular 37
further requires amendment to the SAFE registrations in the event of any changes with respect
to the basic information of the offshore special purpose vehicle, such as changes of the offshore
special purpose vehicle’s name and operational term, or any significant changes with respect
to the PRC individual shareholder, such as the increase or decrease of capital contributions,
share transfer or exchange, or mergers or divisions. Circular 37 is applicable to our
shareholders who are PRC residents. If our shareholders who are PRC residents fail to make
the required registration or to update the previously filed registration, our PRC subsidiaries
may be prohibited from distributing their profits or the proceeds from any capital reduction,
share transfer or liquidation to us, and we may also be prohibited from making additional
capital contributions into our PRC subsidiaries. In February 2015, SAFE promulgated a Notice
on Further Simplifying and Improving Foreign Exchange Administration Policy on Direct
Investment ()( “ Notice 13 ”),
effective from June 2015, and further amended by SAFE on December 30, 2019. Under Notice
13, applications for foreign exchange registration of inbound foreign direct investments and
outbound overseas direct investments, including those required under Circular 37, will be filed
with qualified banks instead of SAFE. The qualified banks will directly examine the
applications and accept registrations under the supervision of SAFE. We cannot assure you that
all our Shareholders will at all times comply with the registration procedures as required under
these regulations. The failure or inability of the relevant shareholders to comply with the
registration procedures set forth in these regulations may subject us to fines and legal
sanctions. Moreover, failure to comply with the various foreign exchange registration
requirements described above could result in liability under PRC law for circumventing
applicable foreign exchange restrictions. As a result, our business operations and our ability to
distribute profits to you could be materially and adversely affected.
PRC regulations of loans and direct investment by offshore holding companies to PRC
entities may delay or prevent us from using the proceeds of the Global Offering to make
loans or additional capital contributions to our PRC subsidiaries.
Any loans provided by our offshore holding companies to our PRC subsidiaries are
subject to PRC regulations and such loans must be registered with the local branch of the
SAFE. Additionally, if we finance such subsidiary by means of additional capital contributions,
these capital contributions must be registered, reported or filed with certain government
authorities, including the Ministry of Commerce (the “ MOFCOM ”), the State Administration
for Market Regulation (the “ SAMR ”) and the SAFE or their local counterparts. We cannot
assure you that we will be able to obtain these government registrations or approvals or to
complete registration procedures on a timely basis, if at all, with respect to future loans or
capital contributions by us to our subsidiaries or any of their respective subsidiaries. If we fail
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to obtain such approvals or registrations, our ability to make equity contributions or provide
loans to our PRC subsidiaries or to fund their operations may be materially and adversely
affected. This may materially and adversely affect our PRC subsidiaries’ liquidity, their ability
to fund their working capital and expansion projects, and their ability to meet their obligations
and commitments. As a result, this may have a material adverse effect on our business,
financial condition and results of operations.
We may rely on dividends and other distributions on equity paid by our PRC subsidiaries
to fund any cash and financing requirements we may have. Any limitation on the ability
of our PRC subsidiaries to make payments to us could have a material and adverse effect
on our ability to conduct our business or financial condition.
We are a holding company incorporated in the Cayman Islands, and we may rely on
dividends and other distributions on equity that may be paid by our subsidiaries for our cash
and financing requirements, including the funds necessary to pay dividends and other cash
distributions to the holders of our Shares and service any debt we may incur. If any of our
subsidiaries incur debt on their own behalf in the future, the instruments governing the debt
may restrict their ability to pay dividends or make other distributions to us. Under PRC laws
and regulations, our PRC subsidiaries may pay dividends only out of their respective
accumulated profits as determined in accordance with PRC accounting standards and
regulations. In addition, our PRC subsidiaries are required to set aside at least 10% of its
after-tax profits each year, after making up previous years’ accumulated losses, if any, to fund
certain statutory reserve funds, until the aggregate amount of such a fund reaches 50% of its
registered capital. Such reserve funds cannot be distributed to us as dividends.
Any limitation on the ability of our PRC subsidiaries to pay dividends or make other
kinds of payments to us could materially and adversely limit our ability to grow, make
investments or acquisitions that could be beneficial to our business, pay dividends to our
investors or other obligations to our suppliers, or otherwise fund and conduct our business.
Failure to comply with PRC regulations regarding the registration requirements for
employee share ownership plans or share option plans may subject the PRC plan
participants or us to fines and other legal or administrative sanctions.
In 2012, the SAFE, promulgated the Circular on Issues Concerning the Foreign Exchange
Administration for Domestic Individuals Participating in Stock Incentive Plan of Overseas
Publicly Listed Company (ྌ̮
). Pursuant to these rules, PRC citizens and non-PRC citizens who
reside in China for a continuous period of not less than one year and participate in any stock
incentive plan of an overseas publicly listed company are required to register with SAFE
through a domestic qualified agent, which could be the PRC subsidiaries of such overseas-
listed company, and complete certain other procedures, unless certain exceptions are available.
In addition, an overseas-entrusted institution must be retained to handle matters in connection
with the exercise or sale of stock options and the purchase or sale of shares and interests. We
and our executive officers and other employees who are PRC citizens or non-PRC citizens
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living in China for a continuous period of not less than one year and have been granted options
will be subject to these regulations when our company becomes an overseas-listed company
upon the completion of the Global Offering. Failure to complete SAFE registrations may
subject them or us to fines or supervision measures. We also face regulatory uncertainties that
could restrict our ability to adopt additional incentive plans for our directors, executive officers
and employees.
In addition, the STA, has issued certain circulars concerning employee share options and
restricted shares. Under these circulars, our employees working in China who exercise share
options or are granted restricted shares will be subject to PRC individual income tax. Our PRC
subsidiary has obligations to file documents related to employee share options or restricted
shares with relevant tax authorities and to withhold individual income taxes for those
employees who exercise their share options. If our employees fail to pay or we fail to withhold
their income taxes according to relevant laws and regulations, we may face sanctions imposed
by the tax authorities or other PRC government authorities.
We are subject to filings and other requirements from the CSRC or other PRC regulatory
authorities for the listing and trading of our Shares on the Stock Exchange.
On February 17, 2023, the China Securities Regulatory Commission (“ CSRC ”)
promulgated the Trial Administrative Measures of Overseas Securities Offering and Listing by
Domestic Companies ()( “ Overseas Listing
Trial Measures ”) and relevant supporting guidelines, which came into effect on March 31,
2023. The Overseas Listing Trial Measures have comprehensively improved and reformed the
existing regulatory regime for overseas offering and listing of PRC domestic companies’
securities and will regulate both direct and indirect overseas offering and listing of PRC
domestic companies’ securities. Any such domestic company that is deemed to conduct
overseas offering and listing activities, including both the Global Offering and any further
capital raising, shall file with the CSRC in accordance with the Overseas Listing Trial
Measures.
We will file with the CSRC within the specific time limit as required by the Overseas
Listing Trial Measures. In addition, it is uncertain whether we can or how long it will take us
to complete the CSRC filing. Any failure to complete the CSRC filing may impede the Global
Offering and may subject us to sanctions by the CSRC. Furthermore, such failure may
adversely affect our ability to finance the development of our business and may have a material
adverse effect on our business and financial condition.
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RISKS RELATING TO OUR OPERATIONS
Our future success depends on our ability to attract, retain and motivate senior
management, qualified medical professionals and scientific employees.
We are highly dependent on the expertise of the members of our research and
development team, as well as the principal members of our management. We have entered into
employment agreements with our executive officers, but each of them may terminate their
employment with us.
Recruiting, retaining and motivating qualified management, scientific, clinical and sales
and marketing personnel will also be critical to our success. The loss of the services of our
executive officers or other key employees, in particular our core R&D team members, could
impede the achievement of our research, development and commercialization objectives and
seriously harm our ability to successfully implement our business strategy. Further, replacing
executive officers and key employees 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
drugs. Competition to hire from this limited pool is intense, and we may be unable to hire,
train, retain or motivate these key personnel on acceptable terms given the competition among
numerous biopharmaceutical companies for similar personnel. We also experience competition
for the hiring of scientific and clinical personnel from universities and research institutions.
If we fail to effectively manage our anticipated growth or execute on our growth
strategies, our business, financial condition, results of operations and prospects could
suffer.
Our future financial performance and our ability to commercialize our drug candidates
will also depend, in part, on our ability to effectively manage our growth, and our management
may also have to divert a disproportionate amount of its attention away from day-to-day
activities in order to implement our long-term development strategies. For details, see
“Business — Our Business Strategies.” Pursuing our growth strategies has resulted in, and will
continue to result in, substantial demands on capital and other resources. In addition, managing
our growth and executing on our growth strategies will require, among other things, our ability
to continue to identify and develop promising drug candidates in the competitive global and
PRC biopharmaceutical market, effective coordination and integration of new facilities and
new teams that we may develop, successful hiring and training of personnel, as well as
effective and efficient financial and management control and quality control.
All of these endeavors will require substantial management attention and efforts and
significant additional expenditures. If we fail to expand at our expected pace, we may face
capacity constraints in the future which may adversely affect our business and financial
condition. We cannot assure you that we will be able to execute our business strategies and
manage any future growth effectively and efficiently, and any failure to do so may materially
and adversely affect our ability to capitalize on new business opportunities, which in turn may
have a material and adverse effect on our business, financial condition, results of operations,
and prospects.
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Our potential engagement in acquisitions or strategic partnerships may increase our
capital requirements, dilute the value of your investment in our Shares, cause us to incur
debt or assume contingent liabilities, and subject us to other risks.
To enhance our growth, we may acquire businesses, products, technologies or know-how
or enter into strategic partnerships that we believe would benefit us in terms of product
development, technology advancement or distribution network. Any potential acquisition or
strategic partnership may entail numerous risks, including, but not limited to:
 increased operating expenses and cash requirements;
 the assumption of additional indebtedness or contingent liabilities;
 the issuance of our equity securities;
 assimilation of operations, intellectual property and products of an acquired
company, including difficulties associated with integrating new personnel;
 the diversion of our management’s attention from our existing product programs and
initiatives in pursuing such a strategic merger or acquisition;
 retention of key employees, the loss of key personnel, and uncertainties in our
ability to maintain key business relationships;
 risks and uncertainties associated with the assimilation of operations, corporate
culture and personnel of the acquired business;
 risks and uncertainties associated with the counterparty, including the prospects of
that party and its existing drugs or drug candidates;
 our inability to generate revenue from acquired technology and/or products
sufficient to meet our objectives in undertaking the acquisition or even to offset the
associated acquisition and maintenance costs; and
 changes in accounting principles relating to recognition and measurement of our
investments that may have a significant impact on our financial results.
In addition, if we undertake acquisitions, we may issue dilutive securities, assume or
incur debt obligations, incur large one-time expenses and acquire intangible assets that could
result in significant future amortization expense. Moreover, we may not be able to locate
suitable acquisition opportunities and this inability could impair our ability to grow or obtain
access to technology or products that may be important to the development of our business.
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We may be involved in claims, disputes, litigation, arbitration or other legal proceedings
in the ordinary course of business.
From time to time, we may be involved in inspections, claims, disputes and legal
proceedings in our ordinary course of business. These may concern issues relating to, among
others, product liability, privacy protection, environmental and safety matters, breach of
contract, employment or labor disputes and intellectual property rights. Any inspections,
claims, disputes or legal proceedings initiated by us or brought against us, our management or
directors, with or without merit, may result in substantial costs and diversion of resources, and
if we are unsuccessful, could materially harm our reputation. Furthermore, inspections, claims,
disputes or legal proceedings against us, our management or directors may be due to actions
taken by our counterparties, such as our suppliers, CROs and other service providers. Even if
we are able to seek indemnity from them, they may not be able to indemnify us in a timely
manner, or at all, for any costs that we incur as a result of such claims, disputes and legal
proceedings.
Our reputation is important to our success. Negative publicity with respect to us, our
management, employees, business partners, affiliates, or our industry, may materially and
adversely affect our reputation, business, results of operations and prospect.
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. However, our
reputation is vulnerable to potential threats that can be difficult or impossible to control, and
costly or impossible to remediate. 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 CROs, CSOs and CDMOs to 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 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.
We may be exposed to risks of conducting our business and operations in international
markets.
International markets are an important component of our growth strategy. We plan to
explore market opportunities overseas, where we believe there is substantial demand for our
drug candidates, and we intend to identify and collaborate with reputable local partners that
have proven track record to maximize the global value of our drug candidates. We will also
continue to seek licensing and co-development opportunities with global MNCs, and expand
our global clinical programs. For more details, see “Business — Our Business Strategies.”
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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 collaboration or licensing arrangements with third parties may
increase our expenses or divert our management’s attention from the development of
drug candidates;
 changes in a specific country’s or region’s political and cultural climate or economic
condition;
 differing regulatory requirements for drug approvals and marketing internationally;
 difficulty of effective enforcement of contractual provisions in local jurisdictions;
 potentially reduced protection for intellectual property rights;
 unexpected changes in tariffs, trade barriers and regulatory requirements;
 compliance with tax, employment, immigration and labor laws for employees
traveling abroad; and
 business interruptions resulting from geo-political actions, including war and
terrorism, or natural disasters, including earthquakes, volcanoes, typhoons, floods,
hurricanes and fires.
These and other risks may materially adversely affect our ability to attain or sustain
revenue and profits from international markets.
Increased labor costs could slow our growth and adversely affect our operations and
profitability.
Our operations depend in part on the skills and know-how of our employees. In recent
years, the average labor cost in the global biopharmaceutical market, particularly for highly
skilled and experienced personnel, has been steadily increasing as the competition for qualified
employees has become more intense. We cannot assure you that there will be no further
increase in labor cost, which may adversely affect our operations and financial condition. In
addition, share options and other share-based incentives granted under our existing or future
share-based incentive arrangements and scheme could adversely affect our costs and our results
of operations. See also “— Risks Relating to Our Financial Position and Need for Additional
Capital — We have granted, and may continue to grant, certain awards under our share
incentive plan, which may result in increased share-based compensation expenses.”
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Changes in international trade policies and political tensions may adversely impact our
business and results of operations.
We are susceptible to constantly changing international economic, regulatory, social and
political conditions, and local conditions in foreign countries and regions. Tensions and
political concerns between China and other countries or regions may adversely affect our
business, financial condition, results of operations, cash flows and prospects. China’s political
relationships with foreign countries and regions may affect the prospects of our relationship
with third parties, such as business partners, suppliers and future customers. There can be no
assurance that our existing or potential service providers or collaboration partners will not alter
their perception of us or their preferences as a result of adverse changes to the state of political
relationships between China and the relevant foreign countries or regions. Any tensions and
political concerns between China and the relevant foreign countries or regions may cause a
decline in the demand for our future products and adversely affect our business, financial
condition, results of operations, cash flows and prospects. Rising trade and political tensions,
as well as changes in relevant government policies could reduce levels of trades, investments,
technological exchanges and other economic activities between China and other countries and
regions. For example, on February 21, 2025, U.S. President Donald J. Trump issued a memo
entitled the “America First Investment Policy” (the “ America First Memo ”), outlining the
ongoing review and consideration of potential new or expanded restrictions on U.S. outbound
investment in the PRC in sectors such as semiconductors, artificial intelligence, quantum,
biotechnology, hypersonics, aerospace, advanced manufacturing, and directed energy. The
America First Memo also contemplates potential restrictions on investments in publicly traded
securities by pension funds, university endowments and other limited partner investors. Such
political tensions and policy changes would have an adverse effect on global economic
conditions, the stability of global financial markets, and international trade policies.
While we have not started commercialization of drug candidates, any rising trade and
political tensions or unfavorable government policies on international trade, such as capital
controls or tariffs, may affect the competitive position of our drug products. In addition, rising
trade and political tensions, heightened government scrutiny or unfavorable government
policies may also affect our existing and future relationships with shareholders and business
partners, including our suppliers, CROs and CDMOs, the provision of research and
development and other services, the supplies of materials and products, the hiring of scientists
and other research and development personnel, and import or export of raw materials in
relation to drug development, or prevent us from selling our drug products in certain countries.
Any failure in confirming and continuing business relationships with our existing partners or
any delay in identifying and entering into commercially reasonable business relationship with
a new partner could harm our ability to develop, manufacture and distribute our drug
candidates as planned or within budget, which could materially adversely affect our business,
financial condition and results of operations. In particular, if any new tariffs, legislation and/or
regulations, including the recently proposed BIOSECURE Act aiming at discouraging federal
funding to, and contracting with, entities that use biotechnology equipment or services
provided by certain Chinese biotechnology companies, are implemented, or if existing trade
agreements are renegotiated, such changes could limit our ability to expand into certain
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markets and have an adverse effect on our business, financial condition and results of
operations. In addition, our results of operations could be adversely affected if any such
tensions or unfavorable government trade policies harm the Chinese economy or the global
economy in general.
We may be subject to natural disasters, health epidemics, acts of war or terrorism or
other factors beyond our control.
Natural disasters, health epidemics, acts of war or terrorism or other factors beyond our
control may adversely affect the economy, infrastructure and livelihood of the people in the
regions where we conduct our business. Our operations 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
syndrome, or SARS, Ebola, Zika, COVID-19, other factors beyond our control, such as power,
water or fuel shortages, failures, malfunction and breakdown of information management
systems, unexpected maintenance or technical problems, or are susceptible to potential wars or
terrorist attacks.
The occurrence of a disaster or a prolonged outbreak of an epidemic illness, including the
COVID-19 pandemic, or other adverse public health developments in which we operate our
business could materially disrupt our business and operations. These uncertain and
unpredictable factors include, but are not limited to, adverse effects on the economy, potential
delays of our ongoing and future clinical trials, and disruptions to the operations of our
business partners and CROs.
Acts of war or terrorism may also injure our employees, cause loss of lives, disrupt our
business network and destroy our markets. Any of the foregoing events and other events
beyond our control 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 and results of 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.
We maintain industry-standard benefit plans in accordance with relevant laws and
regulations, based on our assessment of our operational needs and industry practice. Although
we maintain insurance coverage for adverse events in 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.
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In line with general market practice, we have elected not to maintain certain types of
insurances, such as business interruption insurance or key man insurance. Our insurance
coverage may 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.
We may be unable to detect, deter and prevent all instances of bribery, fraud or other
misconduct committed by our employees or third parties.
We may be exposed to fraud, bribery or other misconduct committed by our employees
or third parties that could subject us to financial losses and sanctions imposed by governmental
authorities, which may adversely affect our reputation. During the Track Record Period and up
to the Latest Practicable Date, we were not aware of any instances of fraud, bribery, or other
misconduct involving employees and other third parties that had any material and adverse
impact on our business and results of operations. However, we cannot assure you that there will
not be any such instances in future. Although we consider our internal control policies and
procedures to be adequate, we may be unable to prevent, detect or deter all such instances of
misconduct by our employees or third parties. Any such misconduct committed against our
interests, which may include past acts that have gone undetected or future acts, may have a
material adverse effect on our business, results of operations and reputation.
Our information technology systems, or those used by our partners or other contractors
or consultants, may fail or suffer security breaches.
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. If such an event were to occur and cause
interruptions in our operations, it could result in a material disruption of our research and
development programs. For example, our data may not be backed up in a timely manner and
the loss of clinical trial data from ongoing or future clinical trials for any of our drug
candidates could result in delays in regulatory approval efforts and significantly increase costs
to recover or reproduce the data. 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.
Our risk management and internal control systems may not be thorough or effective in all
respects.
We seek to establish risk management and internal control systems consisting of an
organizational framework, policies, procedures and risk management methods that are
appropriate for our business operations, and seek to continue to improve these systems. See
“Business — Risk Management and Internal Control” for further details. However, due to the
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inherent limitations in the design and implementation of risk management and internal control
systems, we cannot assure that our risk management and internal control systems will be able
to identify, prevent and manage all risks. Our internal procedures are designed to monitor our
operations and ensure their overall compliance. However, our internal control procedures may
be unable to identify all non-compliance incidents in a timely manner or at all. It is not always
possible to timely detect and prevent fraud and other misconduct committed by our employees
or third parties, and the precautions we take to prevent and detect such activities may not be
effective.
Furthermore, we cannot assure you that our risk management and internal control systems
will be effectively implemented. Since our risk management and internal control systems
depend on their implementation by our employees, we cannot assure you that all of our
employees will adhere to such policies and procedures, and the implementation of such policies
and procedures may involve human errors or mistakes, which may materially and adversely
affect our business and results of operations. Moreover, as we are likely to offer a broader and
more diverse range of services and solutions in the future, the expansion and diversification of
our service offerings will require us to continue to enhance our risk management capabilities.
If we fail to adapt our risk management policies and procedures to our evolving business in a
timely manner, our business, financial condition and results of operations could be materially
and adversely affected.
Our leased properties may be subject to non-compliances or challenges that could
potentially affect our future use of them.
We have leased certain properties in China as our offices and R&D facilities. Pursuant to
the Measures for Administration of Lease of Commodity Properties (ॡ༣၍ଣ፬
), 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, our lease agreements in China had not been registered.
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. If any of our leases is terminated or becomes
unenforceable as a result of challenges from third parties, we would need to seek alternative
properties and incur relocation costs. Any relocation could lead to disruptions to our operations
and adversely affect our business, financial conditions and results of operations.
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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.
Y ou may experience difficulties in effecting service of process upon or enforcing foreign
judgments against us or our Directors or officers.
Most of our assets are situated in the PRC and most of our directors and officers reside
in the PRC. Therefore, there remains the possibility that it may be difficult to effect service of
process outside the PRC upon most of our directors and officers, including with respect to
matters arising under applicable securities laws. The PRC does not have treaties providing for
the reciprocal recognition and enforcement of civil case judgments of courts with the United
States and many other countries. Consequently, you may experience difficulties in enforcing
against us or our directors or officers in the PRC any judgments obtained from courts outside
of the PRC.
On July 14, 2006, Hong Kong and China 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 Pursuant to Choice of
Court Agreements Between Parties Concerned (ʝႩ̙ձ
τર), or the Arrangement, pursuant to which a
party with a final court judgment rendered by a Hong Kong court requiring payment of money
in a civil and commercial case according to a choice of court agreement in writing may apply
for recognition and enforcement of the judgment in China. Similarly, a party with a final
judgment rendered by a Chinese court requiring payment of money in a civil and commercial
case pursuant to a choice of court agreement in writing may apply for recognition and
enforcement of such judgment in Hong Kong. On January 18, 2019, the Supreme People’s
Court and the Hong Kong Government signed 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), which has come into effect on January 29, 2024 and
superseded the Arrangement, or the New Arrangement, which seeks to establish a mechanism
with greater clarity and certainty for recognition and enforcement of judgments in wider range
of civil and commercial matters between Hong Kong and the mainland. The New Arrangement
discontinued the requirement for a choice of court agreement for bilateral recognition and
enforcement. 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. However, we cannot guarantee
that all judgments made by Hong Kong courts will be recognized and enforced in the PRC, as
whether a specific judgment will be recognized and enforced is still subject to a case-by-case
examination by the relevant court in accordance with the New Arrangement.
RISK FACTORS
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RISKS RELATING TO THE GLOBAL OFFERING
There has been no prior public market for our Shares prior to the Global Offering. An
active trading market for our Shares may not develop or be sustained and the trading
prices and volume of our Shares may be volatile.
Prior to the completion of the Global Offering, there has been no public market for our
Shares. There can be no guarantee that an active trading market for our Shares will develop or
be sustained after completion of the Global Offering. The Offer Price is the result of
negotiations between our Company and the Joint Representatives (for themselves and on behalf
of the Underwriters), which may not be indicative of the price at which our Shares will be
traded following completion of the Global Offering. The market price of our Shares may drop
below the Offer Price at any time after completion of the Global Offering. We have applied to
the Stock Exchange for the listing of, and permission to deal in the Share. A Listing on the
Stock Exchange, however, does not guarantee that an active and liquid trading market for our
Shares will develop, or if it does develop, that it will be sustained following the Global
Offering, or that the market price of the Shares will not decline following the Global Offering.
The trading price and trading volume and of our Shares may be volatile and could
fluctuate widely in response to factors beyond our control, including general market conditions
of the securities markets in Hong Kong, China, the United States and elsewhere in the world.
In particular, the performance and fluctuation of the market prices of other companies with
business operations located mainly in China that have listed their securities in Hong Kong may
affect the volatility in the price of and trading volumes for our Shares. A number of
China-based companies have listed their securities, and some are in the process of preparing
for listing their securities, in Hong Kong. Some of these companies have experienced
significant volatility. The trading performances of the securities of these companies at the time
of or after their offerings may affect the overall investor sentiment towards China-based
companies listed in Hong Kong and consequently may impact the trading performance of our
Shares. These broad market and industry factors may significantly affect the market price and
volatility of our Shares, regardless of our actual operating performance, and may result in
losses on your investment in our Shares.
In addition to market and industry factors, the price and trading volume for our Shares
maybe highly volatile for specific business reasons. In particular, factors such as variations in
our revenue, earnings, and cash flow could cause the market price of our Shares to change
substantially. Any of these factors may result in large and sudden change in the volume and
trading price of our Shares.
RISK FACTORS
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The actual or perceived sale or availability for sale of substantial amounts of our Shares,
especially by our directors, executive officers and substantial Shareholders, could
adversely affect the market price of our Shares.
Future sales of a substantial number of our Shares, especially by our directors, executive
officers and existing Shareholders, or the perception or anticipation of such sales, could
negatively impact the market price of our Shares in Hong Kong and our ability to raise equity
capital in the future at a time and price that we deem appropriate.
The Shares held by our existing Shareholders are subject to certain lock-up periods. See
“Underwriting — Underwriting Arrangements and Expenses.” While we currently are not
aware of any intention of such persons to dispose of significant amounts of their Shares after
the expiry of the lock-up periods, we cannot assure you that they will not dispose of any Shares
they may own now or in the future. The effect of such disposal, if any, on the market price of
the Shares cannot be predicted.
Y ou will incur immediate and substantial dilution and may experience further dilution in
the future.
As the Offer Price of Shares is higher than the net tangible book value per share of our
Shares immediately prior to the Global Offering, purchasers of our Shares in the Global
Offering will experience an immediate dilution. If we issue additional Shares in the future,
purchasers of our Shares in the Global Offering may experience further dilution in their
shareholding percentage.
We cannot assure you that we will declare and distribute any amount of dividends in the
future.
We currently intend to retain most, if not all, of our available funds and any future
earnings to fund the development and growth of our business. As a result, we have not yet
adopted a dividend policy with respect to future dividends. Therefore, you should not rely on
an investment in our Shares as a source for any future dividend income.
Our Board has discretion as to whether to distribute dividends, subject to certain
restrictions under Cayman Islands law, namely that our Company may pay dividends out of
profits or share premium, provided always that in no circumstances may a dividend be paid out
of share premium if this would result in our Company being unable to pay its debts as they fall
due in the ordinary course of business. In addition, our Shareholders may by ordinary
resolution declare a dividend, but no dividend may exceed the amount recommended by our
Board. Even if our Board decides to declare and pay dividends, the timing, amount and form
of future dividends, if any, will depend on, among other things, our future results of operations
and cash flow, our capital requirements and surplus, the amount of distributions, if any,
received by us from our subsidiary, our financial condition, contractual restrictions and other
factors deemed relevant by our board of directors. Accordingly, the return on your investment
in our Shares will likely depend entirely upon any future price appreciation of our Shares.
There is no guarantee that our Shares will appreciate in value or even maintain the price at
which you purchased the Shares. Y ou may not realize a return on your investment in our Shares
and you may even lose your entire investment in our Shares.
RISK FACTORS
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We may allocate the net proceeds from this offering in ways that you and other
Shareholders may not agree.
Our management will have broad discretion in the application of the net proceeds from
this offering, including for any of the purposes described in the section titled “Future Plans and
Use of Proceeds.” Because of the number and variability of factors that will determine our use
of the net proceeds from this Global Offering, their ultimate use may vary substantially from
their currently intended use. Our management might not apply the net proceeds in ways that
ultimately increase the value of your investment, and the failure by our management to apply
these funds effectively could harm our business. The failure by our management to apply these
funds effectively could have a material adverse effect on our business, financial condition and
results of operation. Y ou will not have the opportunity, as part of your investment decision, to
assess whether proceeds are being used appropriately. Y ou must rely on the judgment of our
management regarding the application of the net proceeds of this Global Offering.
The industry facts, statistics and forecasts in this prospectus that were obtained from
various government publications and the industry report have not been independently
verified.
This prospectus, particularly the section headed “Industry Overview,” contains
information and statistics relating to the healthcare market. Such information and statistics
have been derived from third-party reports, either commissioned by us or publicly accessible,
and other publicly available sources. The information and statistics from such sources have not
been independently verified by us, the Joint Sponsors, the Joint Representatives, the Overall
Coordinators, the Joint Global Coordinators, the Joint Bookrunners, the Joint Lead Managers,
the Underwriters, and other capital market intermediaries, any of our or their respective
directors, officers or representatives or any other party, other than Frost & Sullivan, involved
in the Global Offering and no representation is given as to its accuracy. Collection methods of
such information may be flawed or ineffective, or there may be discrepancies between
published information and market practice, which may result in the statistics being inaccurate.
Y ou should therefore not place undue reliance on such information. In addition, we cannot
assure you that such information is stated or compiled on the same basis or with the same
degree of accuracy as similar statistics presented elsewhere. In any event, you should consider
carefully the importance placed on such information or statistics.
Y ou should read the entire prospectus carefully and should not rely on any information
contained in press articles or other media regarding us and the Global Offering.
We strongly caution you not to rely on any information contained in press articles or other
media regarding us and the Global Offering. Prior to the publication of this prospectus, there
has been press and media coverage regarding us. Such press and media coverage may include
references to certain information that does not appear in this prospectus, including certain
operating and financial information and projections, valuations and other information. We have
not authorized the disclosure of any such information in the press or media and do not accept
any responsibility for any such press or media coverage or the accuracy or completeness of any
such information or publication. We make no representation as to the appropriateness,
accuracy, completeness or reliability of any such information or publication. To the extent that
any such information is inconsistent or conflicts with the information contained in this
prospectus, we disclaim responsibility for it and you should not rely on such information.
RISK FACTORS
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In preparation for the Listing, we have sought the following waivers from strict
compliance with the relevant provisions of the Listing Rules and certificates of exemption from
strict compliance with the relevant provisions of the Companies (Winding Up and
Miscellaneous Provisions) Ordinance:
MANAGEMENT PRESENCE IN HONG KONG
According to Rule 8.12 of the Listing Rules, our Company must have sufficient
management presence in Hong Kong. This normally means that at least two of our executive
Directors must be ordinarily resident in Hong Kong.
Since all our business operations are not principally located, managed or conducted in
Hong Kong, and our Directors consider that the relocation of our executive Directors to Hong
Kong or the appointment of additional executive Directors who will be ordinarily resident in
Hong Kong would not be beneficial to, or appropriate for, our Company and therefore would
not be in the best interests of our Company and our Shareholders as a whole, our Company does
not, and, for the foreseeable future, will not, have two executive Directors who are ordinarily
resident in Hong Kong for the purpose of satisfying the requirements under Rule 8.12 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 Rule 8.12 of the Listing
Rules. We will ensure that there is a regular and effective communication between the Stock
Exchange and us by way of the following arrangements:
(a) Authorized representatives : both of our Company’s authorized representatives,
Dr. ZHU Zhongyuan (Ⴣ), chairman of the Board, executive Director and our
chief executive officer, and Ms. TSANG Wing Man ( ಀ጑ත), a joint company
secretary of our Company, will act as our Company’s principal channels of
communication with the Stock Exchange. Accordingly, the authorized
representatives of our Company will be able to meet with the relevant members of
the Stock Exchange on reasonable notice and will be readily contactable by
telephone, facsimile (if any) and email. Each of the authorized representatives of our
Company has means of contacting all Directors (including our independent
non-executive Directors) promptly at all times as and when the Stock Exchange
proposes to contact a Director with respect to any matter;
(b) Directors : each Director has provided his/her mobile phone number, office phone
number, fax number (if any) and e-mail address to the authorized representatives of
our Company and the Stock Exchange, and in the event that any Director expects to
travel or otherwise be out of the office, he/she will provide the phone number of the
place of his/her accommodation to the authorized representatives.
Each of our Directors not ordinarily residing in Hong Kong possesses or can apply
for valid travel documents to visit Hong Kong and will be able to meet with the
relevant members of the Stock Exchange within a reasonable period of time;
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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(c) Compliance advisor : we have appointed First Shanghai Capital Limited as our
Compliance Advisor, in compliance with Rule 3A.19 of the Listing Rules, who will,
among other things and in addition to the authorized representatives and our
Directors, also act as an additional channel of communication with the Stock
Exchange from the Listing Date to the date when our Company complies with Rule
13.46 of the Listing Rules in respect of its financial results for the first full financial
year immediately following the Listing Date. Pursuant to the Note of Rule 3A.23,
the Compliance Advisor will have access at all times to our authorized
representatives, our Directors and other officers. We shall also ensure that our
authorized representatives, Directors and other officers will promptly provide such
information and assistance as the Compliance Advisor may need or may reasonably
require in connection with the performance of the Compliance Advisor’s duties as
set forth in Chapter 3A of the Listing Rules. We shall ensure that there are adequate
and efficient means of communication among our Company, our authorized
representatives, our Directors, and other officers and the Compliance Advisor, and
will keep the Compliance Advisor fully informed of all communications and
dealings between the Stock Exchange and us.
Any meeting between the Stock Exchange and our Directors will be arranged
through the authorized representatives or the Compliance Advisor or directly with
our Directors within a reasonable time frame. We will inform the Stock Exchange
promptly in respect of any changes in our authorized representatives and/or our
Compliance Advisor; and
(d) Legal advisors : we will also retain legal advisors to advise on on-going compliance
requirements as well as other issues arising under the Listing Rules and other
applicable laws and regulations of Hong Kong after the Listing.
JOINT COMPANY SECRETARIES
Pursuant to Rules 3.28 and 8.17 of the Listing Rules, the company secretary must be an
individual 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. 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); and
(c) a certified public accountant (as defined in the Professional Accountants
Ordinance).
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AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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Pursuant to Note 2 to Rule 3.28 of the Listing Rules, in assessing “relevant experience,”
the Stock Exchange will consider the individual’s:
(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 law and regulations including
the Securities and Futures Ordinance, 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
of taking not less than 15 hours of relevant professional training in each financial
year under Rule 3.29 of the Listing Rules; and
(d) professional qualifications in other jurisdictions.
Pursuant to paragraph 13 of Chapter 3.10 of the Listing Guide, the Stock Exchange will
consider a waiver application by an issuer in relation to Rules 3.28 and 8.17 of the Listing
Rules based on the specific facts and circumstances. Factors that will be considered by the
Stock Exchange include:
(a) whether the issuer has principal business activities primarily outside Hong Kong;
(b) whether the issuer was able to demonstrate the need to appoint a person who does
not have the Acceptable Qualification (as defined under paragraph 11 of Chapter
3.10 of the Listing Guide) nor Relevant Experience (as defined under paragraph 11
of Chapter 3.10 of the Listing Guide) as a company secretary; and
(c) why the directors consider the individual to be suitable to act as the issuer’s
company secretary.
Further, pursuant to paragraph 13 of Chapter 3.10 of the Listing Guide, such waiver, if
granted, will be for a fixed period of time (the “ Waiver Period ”) and on the following
conditions:
(a) the proposed company secretary must be assisted by a person who possesses the
qualifications or experience as required under Rule 3.28 of the Listing Rules and is
appointed as a joint company secretary throughout the Waiver Period; and
(b) the waiver will be revoked if there are material breaches of the Listing Rules by the
issuer.
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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Our Company considers that while it is important for the company secretary to be familiar
with the relevant securities regulation in Hong Kong, he/she also needs to have experience
relevant to our Company’s operations, nexus to the Board and close working relationship with
the management of our Company in order to perform the function of a company secretary and
to take the necessary actions in the most effective and efficient manner. It is for the benefit of
our Company to appoint a person who has been with the Company for a period of time and is
familiar with our Company’s business and affairs as company secretary.
We have appointed Ms. YUAN Jiali ( ঺Գᘆ) and Ms. TSANG Wing Man as our joint
company secretaries. Ms. YUAN Jiali is our head of legal and compliance. Since Ms. YUAN
Jiali does not possess a qualification stipulated in Rule 3.28 of the Listing Rules, she is not able
to solely fulfill the requirements as a company secretary of a listed issuer stipulated under
Rules 3.28 and 8.17 of the Listing Rules. In order to provide support to Ms. YUAN Jiali, we
have appointed Ms. TSANG Wing Man, an associate member of The Chartered Governance
Institute and The Hong Kong Chartered Governance Institute, who meets the requirements
under Rules 3.28 and 8.17 of the Listing Rules, as a joint company secretary to provide
assistance to Ms. YUAN Jiali, for a three-year period from the Listing Date so as to enable her
to acquire the relevant experience (as required under Rule 3.28(2) of the Listing Rules) to duly
discharge her duties.
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 in relation to the appointment of Ms. YUAN Jiali as our joint company
secretary. Pursuant to the Chapter 3.10 of the Listing Guide, such waiver has been granted on
the conditions that:
(a) Ms. TSANG Wing Man is appointed as a joint company secretary to assist
Ms. YUAN Jiali in discharging her functions as a company secretary and in gaining
the relevant experience under Rule 3.28 of the Listing Rules;
(b) our Company will further ensure that Ms. YUAN Jiali has access to the relevant
training and support to enable her to familiarize herself with the Listing Rules and
the duties required of a company secretary of an issuer listed on the Stock Exchange.
Our Hong Kong legal advisors have provided training to Ms. YUAN Jiali on the
principal requirements of the Listing Rules and the Hong Kong laws and regulations
applicable to our Company after the Listing. In addition, Ms. YUAN Jiali will
endeavor to familiarize herself with the Listing Rules, including any updates
thereto, during the three-year period from the Listing;
(c) Ms. YUAN Jiali has confirmed that she will attend no less than 15 hours of training
courses on the Listing Rules, corporate governance, information disclosure, investor
relations as well as the functions and duties of a company secretary of a Hong Kong
listed issuer during each financial year as required under Rule 3.29 of the Listing
Rules;
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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(d) before the expiry of Ms. YUAN Jiali’s initial term of appointment as the company
secretary of our Company, our Company will evaluate her experience in order to
determine if she has acquired the qualifications required under Rule 3.28 of the
Listing Rules; and
(e) this waiver will be revoked immediately if and when Ms. TSANG Wing Man ceases
to provide such assistance during the three-year period, and we undertake to
re-apply to the Stock Exchange for a waiver in the event that Ms. TSANG Wing Man
ceases to meet the requirements under Rule 3.28 of the Listing Rules or otherwise
ceases to serve as a joint company secretary of our Company. In addition, this
waiver is subject to revocation in the event of any material breaches of the Listing
Rules by our Company.
Prior to the end of the three-year period, we will demonstrate and seek the confirmation
from the Stock Exchange that Ms. YUAN Jiali, having had the benefit of Ms. TSANG Wing
Man during the three years, has attained the relevant experience and is capable of discharging
the functions of our company secretary.
See the section headed “Directors and Senior Management” in this prospectus for further
information regarding the qualifications of Ms. YUAN Jiali and Ms. TSANG Wing Man.
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
According to section 342(1)(b) of the Companies (Winding Up and Miscellaneous
Provisions) Ordinance, this prospectus shall include an accountant’s report which contains the
matters specified in the Third Schedule to the Companies (Winding Up and Miscellaneous
Provisions) Ordinance.
According to paragraph 27 of Part I of the Third Schedule to the Companies (Winding Up
and Miscellaneous Provisions) Ordinance, our Company is required to include in this
prospectus a statement as to the gross trading income or sales turnover (as the case may be)
of our Company during each of the three financial years immediately preceding the issue of this
prospectus as well as an explanation of the method used for the computation of such income
or turnover and a reasonable breakdown of the more important trading activities.
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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According to paragraph 31 of Part II of the Third Schedule to the Companies (Winding
Up and Miscellaneous Provisions) Ordinance, our Company is required to include in this
prospectus a report prepared by our Company’s auditor with respect to profits and losses of our
Company in respect of each of the three financial years immediately preceding the issue of the
prospectus and the assets and liabilities of our Company at the last date to which the financial
statements were prepared.
According to section 342A(1) of the Companies (Winding Up and Miscellaneous
Provisions) Ordinance, the SFC may issue, subject to such conditions (if any) as the SFC thinks
fit, a certificate of exemption from strict 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 interests of the
investing public and strict compliance with any or all of such requirements would be irrelevant
or unduly burdensome, or is otherwise unnecessary or inappropriate.
According to Rule 4.04(1) of the Listing Rules, the Accountant’s Report contained in this
prospectus must include, inter alia, the results of our Company in respect of each of the three
financial years immediately preceding the issue of this prospectus or such shorter period as
may be acceptable to the Stock Exchange.
According to Rule 18A.06 of the Listing Rules, an eligible biotech company shall comply
with Rule 4.04 of the Listing Rules modified so that references to “three financial years” or
“three years” in that rule shall instead refer to “two financial years” or “two years,” as the case
may be.
Accordingly, we applied to the SFC for a certificate of exemption from strict compliance
with the requirements under 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 on the following grounds:
(a) our Company is a key player in the global ADC landscape, dedicated to the
development of innovative therapeutics in this fast-growing drug modality to treat
cancer, autoimmune diseases, and beyond, and falls within the scope of biotech
company as defined under Chapter 18A of the Listing Rules;
(b) the Accountant’s Report for the two years ended December 31, 2023 and 2024 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 years ended December 31, 2023 and 2024 in accordance with Chapter 18A of
the Listing Rules, other information required to be disclosed under the Listing Rules
and requirements under the Companies (Winding Up and Miscellaneous Provisions)
Ordinance has been adequately disclosed in this prospectus pursuant to the relevant
requirements;
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AND EXEMPTIONS FROM THE COMPANIES
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(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
came from newly established license and collaboration arrangements, nearly all of
which were only entered into after 2022, whereas our revenue in 2022, which was
minimal and immaterial and was substantially different in nature, was derived
exclusively from consideration paid by potential business partners for biological
materials to evaluate drug candidates, and was not the key business of the Company;
and
(e) our Directors are of the view that the Accountant’s Report covering the two years
ended December 31, 2023 and 2024, together with other disclosures in this
prospectus, has 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 our
Company’s business, assets and liabilities, financial position, trading position,
management and prospects has been included in this prospectus. Therefore, the
exemption would not prejudice the interests of the investing public.
A certificate of exemption has been granted by the SFC under section 342A of the
Companies (Winding Up and Miscellaneous Provisions) Ordinance on the conditions that (i)
particulars of the exemption are set out in this prospectus, and (ii) this prospectus will be issued
on or before April 7, 2025.
THE PRE-IPO EQUITY INCENTIVE PLAN
Under Rule 17.02(1)(b) of, and paragraph 27 of Appendix D1A to, the Listing Rules, and
paragraph 10 of Part I of the Third Schedule to the Companies (Winding Up and Miscellaneous
Provisions) Ordinance, this prospectus is required to include, among other things, details of the
number, description and amount of any shares in or debentures of our Company which any
person has, or is entitled to be given, an option to subscribe for, together with certain
particulars of each option, namely the period during which it is exercisable, the price to be paid
for shares or debentures subscribed for under it, the consideration (if any) given or to be given
for it or for the right to it and the names and addresses of the persons to whom it was given.
According to Chapter 3.6 of the Listing Guide, the Stock Exchange would normally grant
waivers from disclosing the names and addresses of certain grantees if the issuer could
demonstrate that such disclosures would be irrelevant and unduly burdensome, subject to
certain conditions specified therein.
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
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The maximum number of Shares that may be issued pursuant to the share awards under
the Pre-IPO Equity Incentive Plan shall not exceed 22,287,582 Shares in the aggregate,
representing 26.80% of the total number of Shares in issue immediately after completion of the
Global Offering (assuming the Offer Size Adjustment Option and the Over-allotment Option
are not exercised). As of the Latest Practicable Date, our Company had granted all options
under the Pre-IPO Equity Incentive Plan to a total of 139 eligible grantees, including (i) three
Directors and eight senior management members; (ii) three external consultants (all being key
external consultants who serve on the Company’s scientific advisory board); (iii) 25
non-connected employees of our Company (who are not Directors or senior management) each
of whom was granted options to subscribe for 60,000 Shares or more; and (iv) the remaining
100 non-connected employees of our Company, to subscribe for an aggregate of 22,287,582
Shares, representing approximately 26.80% of the total number of Shares in issue immediately
after completion of the Global Offering (assuming the Offer Size Adjustment Option and the
Over-allotment Option are not exercised). For details, please see the section headed “Statutory
and General Information — D. Share Incentive Plan — Pre-IPO Equity Incentive Plan” in
Appendix IV to this prospectus.
We have applied to the Stock Exchange and the SFC, respectively, for, (i) a waiver from
strict compliance with the disclosure requirements under Rule 17.02(1)(b) of, and paragraph 27
of Appendix D1A to the Listing Rules; and (ii) a certificate of exemption under section 342A
of the Companies (Winding Up and Miscellaneous Provisions) Ordinance exempting our
Company from strict compliance with the disclosure requirements under paragraph 10(d) of
Part I of the Third Schedule to the Companies (Winding Up and Miscellaneous Provisions)
Ordinance, on the ground that strict compliance with the above requirements would be unduly
burdensome for our Company for the following reasons:
(a) given that 139 grantees are involved, setting out full details of all the grantees under
the Pre-IPO Equity Incentive Plan in this prospectus would be costly and unduly
burdensome for our Company in light of a significant increase in cost and time for
information compilation and prospectus preparation;
(b) as of the date of this prospectus, except for 11 grantees who are Directors and senior
management members of our Company, the remaining grantees under the Pre-IPO
Equity Incentive Plan are employees or consultants and are not connected persons
of our Company. Disclosing the names, addresses and entitlements on an individual
basis in this prospectus will require number of additional pages of disclosure that
does not provide any material information to the investing public;
(c) the grant and exercise in full of the options under the Pre-IPO Equity Incentive Plan
will not cause any material adverse impact on the financial position of our
Company;
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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(d) deviation from strict compliance with the disclosure requirements would not deprive
potential investors of information necessary for them to make an informed
assessment of the activities, assets, liabilities, financial position, management and
prospects of our Group; and
(e) material information relating to the options under the Pre-IPO Equity Incentive Plan
will be disclosed in this prospectus, including a summary of the major terms of the
Pre-IPO Equity Incentive Plan, the total number of Shares to be issued subject to the
Pre-IPO Equity Incentive Plan, the exercise price per Share, the exercise period, the
potential dilution effect on shareholding and the impact on earnings per Share. Our
Directors consider that the information that is reasonably necessary for the potential
investors to make an informed assessment of our Company in their investment
decision making process has been included in this prospectus.
In light of the above, our Directors are of the view that the grant of the waiver and
exemption sought under this application will not prejudice the interests of the investing public.
The Stock Exchange has granted to us a waiver under the Listing Rules on the conditions
that:
(a) on an individual basis, full details of the options granted under the Pre-IPO Equity
Incentive Plan to each of the Directors, members of senior management, connected
persons of our Company, external consultants and other grantees who have been
granted options to subscribe for 60,000 Shares or above, will be disclosed in
“Statutory and General Information — D. Share Incentive Plan — Pre-IPO Equity
Incentive Plan” in Appendix IV to this prospectus, as required under Rule
17.02(1)(b) of, and paragraph 27 of Appendix D1A to, the Listing Rules, and
paragraph 10 of Part I of the Third Schedule to the Companies (Winding Up and
Miscellaneous Provisions) Ordinance;
(b) in respect of the options granted by our Company under the Pre-IPO Equity
Incentive Plan to the grantees other than those referred to in paragraph (a) above,
disclosures are made of, on an aggregate basis, categorized into lots based on the
number of Shares underlying each individual grantee, being (i) 1 to 10,000 Shares,
(ii) 10,001 to 30,000 Shares, and (iii) 30,001 to 59,999 Shares. For each lot of
Shares, the following details are disclosed in this prospectus, including (1) the
aggregate number of such grantees and the number of Shares underlying the options
granted to them under the Pre-IPO Equity Incentive Plan, (2) the consideration paid
for the grant of the options under the Pre-IPO Equity Incentive Plan, and (3) the
exercise period and the exercise price for the options granted under the Pre-IPO
Equity Incentive Plan;
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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(c) there will be disclosure in this prospectus for the aggregate number of Shares
underlying the options under the Pre-IPO Equity Incentive Plan and the percentage
of our Company’s total issued share capital represented by such number of Shares
as of the date of this prospectus;
(d) the dilutive effect and impact on earnings per Share upon full exercise of the options
under the Pre-IPO Equity Incentive Plan will be disclosed in “Statutory and General
Information — D. Share Incentive Plan — Pre-IPO Equity Incentive Plan” in
Appendix IV to this prospectus;
(e) a summary of the major terms of the Pre-IPO Equity Incentive Plan will be disclosed
in “Statutory and General Information — D. Share Incentive Plan — Pre-IPO Equity
Incentive Plan” in Appendix IV to this prospectus;
(f) the particulars of the waiver will be disclosed in this prospectus;
(g) a full list of all the grantees (including the persons referred to in paragraph (a)
above) who have been granted options to subscribe for Shares under the Pre-IPO
Equity Incentive Plan, containing all the details as required under Rule 17.02(1)(b)
of, and paragraph 27 of Appendix D1A to, the Listing Rules, and paragraph 10 of
the Third Schedule to the Companies (Winding Up and Miscellaneous Provisions)
Ordinance, will be made available for public inspection in accordance with
“Documents Delivered to the Registrar of Companies and Available on Display —
Documents Available for Inspection” in Appendix V to this prospectus; and
(h) the grant of a certificate of exemption under the Companies (Winding Up and
Miscellaneous Provisions) Ordinance from the SFC exempting our Company from
the disclosure requirements provided in paragraph 10(d) of Part I of the Third
Schedule to the Companies (Winding Up and Miscellaneous Provisions) Ordinance.
The SFC has agreed to grant to our Company the certificate of exemption under section
342A of the Companies (Winding Up and Miscellaneous Provisions) Ordinance exempting our
Company from strict compliance with paragraph 10(d) subject to the conditions that:
(a) on an individual basis, full details of the options granted under the Pre-IPO Equity
Incentive Plan to each of the Directors, members of senior management, connected
persons of our Company, external consultants and other grantees who have been
granted options to subscribe for 60,000 Shares or above, will be disclosed in
“Statutory and General Information — D. Share Incentive Plan — Pre-IPO Equity
Incentive Plan” in Appendix IV to this prospectus, as required under paragraph 10
of Part I of the Third Schedule to the Companies (Winding Up and Miscellaneous
Provisions) Ordinance;
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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--- page 148 ---
(b) in respect of the options granted by our Company under the Pre-IPO Equity
Incentive Plan to the grantees other than those referred to in paragraph (a) above,
disclosures are made of, on an aggregate basis, categorized into lots based on the
number of Shares underlying each individual grantee, being (i) 1 to 10,000 Shares,
(ii) 10,001 to 30,000 Shares, and (iii) 30,001 to 59,999 Shares. For each lot of
Shares, the following details are disclosed in this prospectus, including (1) the
aggregate number of such grantees and the number of Shares underlying the options
granted to them under the Pre-IPO Equity Incentive Plan, (2) the consideration paid
for the grant of the options under the Pre-IPO Equity Incentive Plan, and (3) the
exercise period and the exercise price for the options granted under the Pre-IPO
Equity Incentive Plan;
(c) a full list of all the grantees (including the persons referred to in paragraph (a)
above) who have been granted options to subscribe for Shares under the Pre-IPO
Equity Incentive Plan, containing all the details as required under paragraph 10 of
the Third Schedule to the Companies (Winding Up and Miscellaneous Provisions)
Ordinance, will be made available for public inspection in accordance with
“Documents Delivered to the Registrar of Companies and Available on Display —
Documents Available for Inspection” in Appendix V to this prospectus;
(d) the particulars of the exemption will be disclosed in this prospectus; and
(e) this prospectus is issued on or before April 7, 2025.
W AIVER FROM STRICT COMPLIANCE WITH RULE 9.09(B) OF, AND CONSENT
UNDER PARAGRAPH 5(2) OF APPENDIX F1 TO THE LISTING RULES IN RESPECT
OF SUBSCRIPTIONS OF OFFER SHARES BY CLOSE ASSOCIATES OF EXISTING
SHAREHOLDER AS CORNERSTONE INVESTORS
Rule 9.09(b) of the Listing Rules provides, inter alia, that there must be no dealing in the
securities for which listing is sought by any core connected person of the issuer, in the case of
a new applicant, from four clear business days before the expected hearing date until listing is
granted.
Paragraph 5(2) of Appendix F1 to the Listing Rules provides, inter alia, 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 are fulfilled, without the prior written consent of the Stock Exchange.
Chapter 2.3 of the Guide provides that (i) an existing shareholder and/or its close
associates may, provided that the applicant complies with Rules 8.08(1) and 18A.07 of the
Listing Rules, participate in the initial public offering (the “ IPO”) of a Biotech Company (as
defined under Chapter 18A of the Listing Rules). An existing shareholder must subscribe for
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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shares in the IPO as a cornerstone investor if it holds 10% more of the shares in the applicant
prior to IPO, but may subscribe either as a cornerstone investor or placee if it holds less than
10% of the shares in the applicant prior to IPO. The applicant and its sponsors must confirm
that no preference in allocation was given to the existing shareholder; and in the case of
subscription as cornerstone investor, that no preference was given other than the preferential
treatment of assured entitlement at the IPO price and the terms are substantially the same as
other cornerstone investors; and (ii) the applicant must apply for, and the Stock Exchange will
ordinarily grant, a related Rule 9.09 of the Listing Rules waiver, if allocations of shares of a
Biotech Company will be made to a core connected person.
As further described in the section headed “Cornerstone Investors” in this prospectus,
each of following entities has entered into a cornerstone investment agreement as a cornerstone
investor (“ Cornerstone Investor ”) with the Company, the Joint Sponsors, and the Overall
Coordinators to subscribe for the Offer Shares:
(i) LA V Star Opportunities Limited (“ LA V Star”), our Cornerstone Investor, is wholly
owned by LA V Fund VI Opportunities, L.P .. LA V Fund VI, L.P ., and LA V Fund VI
Opportunities, L.P . (collectively “ LA V USD”) are under common control of Dr. SHI
Yi. Therefore, LA V Star is a close associate of LA V USD. As of the Latest
Practicable Date, LA V USD held approximately 23.89% of the total issued share
capital of the Company and was a core connected person of the Company.
(ii) Suzhou Suchuang Biomedical Health V enture Capital Fund Partnership
(Limited Partnership) (ΥྫΆุ(Υྫ))
(“Suzhou Suchuang ”), our Cornerstone Investor, the general partner of which is
Suzhou National Development Asset Management Co., Ltd. (ࠢ
ʮ̡), which is ultimately controlled by Finance Bureau of Suzhou Municipality ( ᘽ
҅). Finance Bureau of Suzhou Municipality is ultimately administered and
supervised by Suzhou Municipal People’s Government (ִ݁.)
China Singapore Suzhou Industrial Park V entures (ࠢ
ʮ̡)( “ CSVC ”), an existing Shareholder of the Company, is directly and
wholly-owned by Suzhou Oriza Holdings Co., Ltd (ʮ̡).
(“Oriza Holdings ”). Oriza Holdings is ultimately controlled by Suzhou Industrial
Park Administrative Committee (ึ), which is a subordinate
government agency (̈ዚ࿴) under Suzhou Municipal People’s Government.
Therefore, Suzhou Suchuang is considered as a close associate of CSVC. As of the
Latest Practicable Date, CSVC held approximately 3.68% of the total issued share
capital of the Company.
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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--- page 150 ---
We have applied for a waiver from strict compliance with the requirements under Rule
9.09(b) of the Listing Rules, and a consent under paragraph 5(2) of Appendix F1 to, the Listing
Rules, to permit LA V Star and Suzhou Suchuang to participate as Cornerstone Investors in the
Global Offering to subscribe for the Offer Shares to be issued by the Company under the
International Offering. The Stock Exchange has agreed to grant the requested waiver and
consent subject to the conditions that:
(a) the Company will comply with the public float requirements of Rules 8.08(1) and
18A.07 of the Listing Rules;
(b) the terms are substantially the same as other cornerstone investors (including (i) the
Offer Shares to be subscribed by and allocated to LA V Star and Suzhou Suchuang
being at the Offer Price; (ii) being subject to a six-month lock up arrangement
following Listing, and (iii) LA V Star and Suzhou Suchuang shall pay and settle in
full the consideration for the Offer Shares before the dealing commence on the
Listing Date) under cornerstone investment agreements following the principles set
out in Chapters 2.3 and 4.15 of the Guide;
(c) the Company and the Joint Sponsors confirm that no preferential treatment has been,
nor will be directly or indirectly, given to LA V Star and Suzhou Suchuang as
cornerstone investors by virtue of their relationship with the Company in any
allocation in the Global Offering, other than the preferential treatment of assured
entitlement under the cornerstone investments which follow the principles set out in
Chapters 2.3 and 4.15 of the Guide that, the cornerstone investment agreements of
LA V Star and Suzhou Suchuang do not contain any material terms which are more
favorable to them than those in the other cornerstone investment agreements; and
(d) details of the subscription of the Offer Shares by LA V Star and Suzhou Suchuang as
Cornerstone Investors under the Global Offering are disclosed in this prospectus,
and details of the allocation will be disclosed in the allotment results announcement
of our Company. For further information about the relevant cornerstone investments,
please refer to the section headed “Cornerstone Investors” in this prospectus.
CONSENT IN RESPECT OF THE PROPOSED SUBSCRIPTION OF OFFER SHARES
BY CONNECTED CLIENTS
Paragraph 5(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))
(collectively, the “ Distributors ”, and each a “ Distributor ”), without the prior written consent
of the Stock Exchange.
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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--- page 151 ---
Paragraph 13(7) of the Appendix F1 to the Listing Rules states that “connected client” in
relation to an exchange participant means any client which is a member of the same group of
companies as such exchange participant.
As further described in the section headed “Cornerstone Investors” in this prospectus, E
Fund Management Co., Ltd. (ʮ̡)( “E Fund Management ”) and E Fund
Management (Hong Kong) Co., Ltd. (ʮ̡)( “ E Fund HK ”) have
entered into cornerstone investment agreements with the Company, the Joint Sponsors, and the
Overall Coordinators to subscribe for the Offer Shares. GF Securities (Hong Kong) Brokerage
is an indirect wholly-owned subsidiary of GF Securities Co., Ltd (ʮ̡)
(“GF Securities , Stock Code: 1776). GF Securities holds 22.6% of the issued share capital of
E Fund Management. Each of E Fund Management and E Fund HK is a member of the same
group of companies as GF Securities and therefore is a “connected client” of GF Securities
(Hong Kong) Brokerage for the purpose of paragraph 13(7) of Appendix F1 to the Listing
Rules.
We have applied for, and the Stock Exchange has granted, a consent under paragraph 5(1)
of Appendix F1 to the Listing Rules to permit each of E Fund Management and E Fund HK to
participate in the Global Offering as Cornerstone Investors on the following basis and
conditions as set out in Paragraph 5 of Chapter 4.15 of the Guide:
(a) any Offer Shares to be allocated to each of E Fund Management and E Fund HK will
be held on behalf of independent third parties;
(b) GF Securities (Hong Kong) Brokerage has not participated, and will not participate,
in the decision-making process or relevant discussions among the Company, the
Underwriters and the Overall Coordinators as to whether Offer Shares will be
allocated to E Fund Management and E Fund HK;
(c) no preferential treatment has been, nor will be, given to E Fund Management and E
Fund HK by virtue of their relationship with GF Securities (Hong Kong) Brokerage
in any allocation of Offer Shares in the International Offering other than the assured
entitlement under the relevant cornerstone investment agreements following the
principles set out in Chapter 4.15 of the Guide that the cornerstone investment
agreements of E Fund Management and E Fund HK do not contain any material
terms which are more favorable to them than those in the other cornerstone
investment agreements;
(d) each of E Fund Management and E Fund HK confirms that to the best of its
knowledge and belief, it has not received and will not receive any preferential
treatment in the Global Offering allocation as a cornerstone investor by virtue of
their relationship with GF Securities (Hong Kong) Brokerage, other than the
preferential treatment of assured entitlement under the cornerstone investments;
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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--- page 152 ---
(e) each of the Company, the Overall Coordinators, E Fund Management and E Fund
HK and GF Securities Brokerage has provided the Stock Exchange with written
confirmations in accordance with Chapter 4.15 of the Guide; and
(f) details of the cornerstone investments and details of the allocations will be disclosed
in this prospectus and the allotment results announcement of our Company. For
further information about the relevant cornerstone investments, please refer to the
section headed “Cornerstone Investors” in this prospectus.
W AIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES
AND EXEMPTIONS FROM THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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--- page 153 ---
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 Listing Rules, the Companies (Winding Up and
Miscellaneous Provisions) Ordinance and the Securities and Futures (Stock Market Listing)
Rules (Chapter 571V of the Laws of Hong Kong) for the purpose of giving information to the
public with regard to our Group. 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 matters the omission of which would make any statement herein or this prospectus
misleading.
CSRC FILING
According to the Overseas Listing Trial Measures, we are required to complete the filing
procedures with the CSRC in connection with the Listing. We have submitted a filing to the
CSRC for application for the Listing on August 28, 2024. The CSRC confirmed completion of
such filing on January 20, 2025 by granting the filing notice to the Company. In granting such
filing notice, the CSRC accepts no responsibility for the financial soundness of us or for the
accuracy of any of the statements made or opinions expressed in this prospectus. 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.
INFORMATION ON THE GLOBAL OFFERING
This prospectus is published solely in connection with the Hong Kong Public Offering,
which forms part of the Global Offering. For applications under the Hong Kong Public
Offering, this prospectus contains the terms and conditions of the Hong Kong Public Offering.
The Hong Kong Offer Shares are offered 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 to give any information in connection with the
Global Offering or to make any representation not contained in this prospectus, and any
information or representation not contained herein must not be relied upon as having been
authorized by our Company, the Joint Sponsors, the Joint Representatives, the Overall
Coordinators, the Joint Global Coordinators, the Joint Bookrunners, the Joint Lead Managers,
the Capital Market Intermediaries, any of the Underwriters, any of our or their respective
affiliates or any of our or their respective directors, officers, employees, advisors, agents or
representatives, or any other persons or parties involved in the Global Offering.
The Listing is sponsored by the Joint Sponsors and the Global Offering is managed by the
Joint Representatives. Pursuant to the Hong Kong Underwriting Agreement, the Hong Kong
Public Offering is fully underwritten by the Hong Kong Underwriters under the terms and
conditions of the Hong Kong Underwriting Agreement. The International Offering is expected
INFORMATION ABOUT THIS PROSPECTUS AND THE GLOBAL OFFERING
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--- page 154 ---
to be fully underwritten by the International Underwriters and subject to the terms and
conditions of the International Underwriting Agreement. For further details on the
Underwriters and the underwriting arrangements, please refer to the section headed
“Underwriting” in this prospectus.
Neither the delivery of this prospectus nor any offering, sale, delivery, subscription or
acquisition made in connection with the Offer Shares shall, under any circumstances, constitute
a representation or create any implication that there has been no change in our affairs since the
date of this prospectus or that the information in this prospectus is correct as of any date
subsequent to the date of this prospectus.
For details of the structure of the Global Offering, including its conditions and the
arrangements relating to the Offer Size Adjustment Option, the Over-allotment Option and
stabilization, please refer to the section headed “Structure of the Global Offering” in this
prospectus.
PROCEDURE FOR APPLICATION FOR HONG KONG OFFER SHARES
The procedure for applying for the Hong Kong Offer Shares is set forth in “How to Apply
for Hong Kong Offer Shares” in this prospectus.
STRUCTURE AND CONDITIONS OF THE GLOBAL OFFERING
Details of the structure of the Global Offering, including its conditions, are set forth in
the section headed “Structure of the Global Offering” in this prospectus.
RESTRICTIONS ON OFFER AND SALE OF THE OFFER SHARES
Each person acquiring the Hong Kong Offer Shares under the Hong Kong Public Offering
will be required to, or be deemed by their acquisition of Hong Kong Offer Shares to, confirms
that they are aware of the restrictions on offers for the Hong Kong Offer Shares described in
this prospectus.
No action has been taken to permit a public offering of the Offer Shares in any
jurisdiction other than in Hong Kong, or the distribution of this prospectus in any jurisdiction
other than Hong Kong. Accordingly, this prospectus may not be used for the purpose 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 sale 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.
INFORMATION ABOUT THIS PROSPECTUS AND THE GLOBAL OFFERING
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Persons applying for or purchasing Offer Shares under the Global Offering are deemed,
by their making an application or purchase, to have represented that they are not associates of
any of our Directors or existing Shareholders or a nominee of any of the foregoing.
APPLICATION FOR LISTING ON THE STOCK EXCHANGE
We have applied to the Stock Exchange for the listing of, and permission to deal in, (a)
the Shares in issue; (b) the Shares to be issued pursuant to the Global Offering (including the
Offer Size Adjustment Option and the Over-allotment Option); and (c) the Shares to be issued
pursuant to the outstanding share options under the Pre-IPO Equity Incentive Plan.
Dealings in the Shares on the Stock Exchange are expected to commence on Tuesday,
April 15, 2025. No part of our Shares or loan capital 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. All Offer Shares will be registered on the Hong Kong Share Register
of our Company in order to enable them to be traded on the Stock Exchange.
The Shares will be traded in board lot of 100 Shares. The stock code of the Shares is 9606.
Under section 44B (1) of the Companies (Winding Up and Miscellaneous Provisions)
Ordinance, any allotment made in respect of any application will be invalid if the listing of,
and permission to deal in, the Shares on the 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 our Company by the
Stock Exchange.
OFFER SIZE ADJUSTMENT OPTION, OVER-ALLOTMENT OPTION AND
STABILIZATION
Details of the arrangements relating to the Offer Size Adjustment Option, the Over-
allotment Option and stabilization are set forth in the section headed “Structure of the Global
Offering” in this prospectus.
SHARES WILL BE ELIGIBLE FOR ADMISSION INTO CCASS
Subject to the granting of the listing of, and permission to deal in, the Shares on the Stock
Exchange and compliance with the stock admission requirements of HKSCC, the Shares will
be accepted as eligible securities by HKSCC for deposit, clearance and settlement in CCASS
with effect from the Listing Date or any other date as determined by HKSCC. Settlement of
transactions between participants of the Stock Exchange 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 HKSCC Operational Procedures in effect from time to time.
INFORMATION ABOUT THIS PROSPECTUS AND THE GLOBAL OFFERING
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All necessary arrangements have been made for the Shares to be admitted into CCASS.
Investors should seek the advice of their stockbrokers or other professional advisors for details
of the settlement arrangements and how such arrangements will affect your rights and interests
as such arrangements may affect their rights and interests.
SHARE REGISTER AND STAMP DUTY
Our principal register of members will be maintained by our principal registrar, Maples
Fund Services (Cayman) Limited, in the Cayman Islands. Our Hong Kong Share Register will
be maintained by the Hong Kong Share Registrar, Computershare Hong Kong Investor Services
Limited, in Hong Kong.
All Offer Shares issued pursuant to applications made in the Hong Kong Public Offering
and the International Offering will be registered on the Hong Kong Share Register of our
Company in Hong Kong. Dealings in the Shares registered in our Hong Kong Share Register
will be subject to Hong Kong stamp duty. For further details of Hong Kong stamp duty, please
seek professional tax advice.
PROFESSIONAL TAX ADVICE RECOMMENDED
Potential investors in the Global Offering are recommended to consult their professional
advisors if they are in any doubt as to the taxation implications of subscribing for, holding and
dealing in the Shares or exercising any rights attached to them. It is emphasized that none of
our Company, the Joint Sponsors, the Joint Representatives, the Overall Coordinators, the Joint
Global Coordinators, the Joint Bookrunners, the Joint Lead Managers, the Capital Market
Intermediaries, the Underwriters, any of their respective affiliates, directors, supervisors,
employees, agents or advisors or any other party involved in the Global Offering accepts
responsibility for any tax effects on, or liabilities of holders of the Shares resulting from the
subscription, purchase, holding or disposal of the Shares or exercising any rights attached to
them.
EXCHANGE RATE CONVERSION
Solely for your convenience, this prospectus contains translations among certain amounts
denominated in Renminbi, Hong Kong dollars and U.S. dollars.
Unless otherwise specified, this prospectus contains certain translations for the
convenience purposes at the following rates: Renminbi into Hong Kong dollars at the rate of
RMB0.9227 to HK$1.00, Renminbi into U.S. dollars at the rate of RMB7.1752 to US$1.00 and
Hong Kong dollars into U.S. dollars at the rate of HK$7.7761 to US$1.00. The RMB to HK$
and RMB to US$ exchange rates are quoted by the PBOC for foreign exchange transactions
prevailing on March 28, 2025.
No representation is made that any amounts in RMB, Hong Kong dollars or U.S. dollars
can be or could have been at the relevant dates converted at the above rate or any other rates
or at all.
INFORMATION ABOUT THIS PROSPECTUS AND THE GLOBAL OFFERING
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LANGUAGE
If there is any inconsistency between this prospectus and its Chinese translation, the
English version of this prospectus shall prevail. The English names of the Chinese laws and
regulations, government authorities, institutions, natural persons, other entities (including
certain of our subsidiaries), facilities, certificates and titles included in this prospectus are
translations of their Chinese names for identification purposes only. In the event of any
inconsistency, the Chinese version shall prevail.
ROUNDING
Certain amounts and percentage figures, such as share ownership and operating data,
included in this prospectus may 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. Any discrepancies in any table, chart or elsewhere between totals and sums of
amounts listed therein are due to rounding.
MARKET SHARE DATA CONVENTION
The statistical and market share information contained in this prospectus has been derived
from official government publications and other sources, including information or data
provided by Frost & Sullivan. 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, our Company, the Joint Sponsors, the Joint
Representatives, the Overall Coordinators, the Joint Global Coordinators, the Joint
Bookrunners, the Joint Lead Managers, the Underwriters, any of our and their respective
directors, supervisors, officers, representatives, employees, advisers or any other persons or
parties involved in the Global Offering make no representation to the appropriateness,
accuracy, completeness or reliability of any such statistical and market share information.
OTHERS
Unless otherwise specified, all references to any shareholdings in our Company following
the completion of the Global Offering assume that the Offer Size Adjustment Option and the
Over-allotment Option are not exercised.
INFORMATION ABOUT THIS PROSPECTUS AND THE GLOBAL OFFERING
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DIRECTORS
Name Address Nationality
Executive Directors
Dr. ZHU Zhongyuan (Ⴣ) Room 403, Building 10
Lane 1299, Dingxiang Road
Pudong New Area
Shanghai
the PRC
Chinese
Mr. ZHANG Shaoren ( ੵჭˁ) Rooms 201-203, Building 2
Lane 76, Nujiang Road
Putuo District
Shanghai
the PRC
Chinese
Ms. SI Wen ( ̡˖) Room 402, No. 44
Lane 438, Guzong Road
Pudong New Area
Shanghai
the PRC
Chinese
Non-executive Directors
Mr. CAI Zhiyang (ݱRoom 1601
No. 8, Lane 299, Y aohong Road
Minhang District
Shanghai
the PRC
Chinese
Dr. YU Tao ( Яᏹ) Room 601, Building 26
No. 139 Zhongshan Avenue West
Tianhe District
Guangzhou, Guangdong Province
the PRC
Chinese
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 159 ---
Name Address Nationality
Independent Non-executive Directors
Mr. XIE Dong (؇Flat E, 15/F
5-17 Western Street
Sai Ying Pun
Hong Kong
Chinese
Mr. GAO Fengyong (ۇRoom 302, No. 12
Lane 199, Baiyang Road
Pudong New Area
Shanghai
the PRC
Chinese
Ms. CHUAI Shuyin ( ౣ᪣ত) Room 1902, No. 110
Lane 2388, Chengshan Road
Pudong New Area
Shanghai
the PRC
Chinese
See the section headed “Directors and Senior Management” in this prospectus for further
details.
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 160 ---
PARTIES INVOLVED IN THE GLOBAL OFFERING
Joint Sponsors Morgan Stanley Asia Limited
46/F, International Commerce Centre
1 Austin Road West
Kowloon
Hong Kong
Jefferies Hong Kong Limited*
26/F, Two International Finance Centre
8 Finance Street, Central
Hong Kong
CITIC Securities (Hong Kong) Limited*
18/F, One Pacific Place
88 Queensway
Hong Kong
(* in no particular order)
Sponsor-Overall Coordinators Morgan Stanley Asia Limited
46/F, International Commerce Centre
1 Austin Road West
Kowloon
Hong Kong
Jefferies Hong Kong Limited*
26/F, Two International Finance Centre
8 Finance Street, Central
Hong Kong
CLSA Limited*
18/F, One Pacific Place
88 Queensway
Hong Kong
(* in no particular order)
Overall Coordinators and Joint Global
Coordinators
Morgan Stanley Asia Limited
46/F, International Commerce Centre
1 Austin Road West
Kowloon
Hong Kong
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 161 ---
Jefferies Hong Kong Limited*
26/F, Two International Finance Centre
8 Finance Street, Central
Hong Kong
CLSA Limited*
18/F, One Pacific Place
88 Queensway
Hong Kong
China International Capital Corporation
Hong Kong Securities Limited
29/F, One International Finance Centre
1 Harbour View Street
Central
Hong Kong
CMB International Capital Limited
45/F, Champion Tower
3 Garden Road
Central
Hong Kong
(* in no particular order)
Joint Representatives Morgan Stanley Asia Limited
46/F, International Commerce Centre
1 Austin Road West
Kowloon
Hong Kong
Jefferies Hong Kong Limited*
26/F, Two International Finance Centre
8 Finance Street, Central
Hong Kong
CLSA Limited*
18/F, One Pacific Place
88 Queensway
Hong Kong
China International Capital Corporation
Hong Kong Securities Limited
29/F, One International Finance Centre
1 Harbour View Street
Central
Hong Kong
(* in no particular order)
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 162 ---
Joint Bookrunners Morgan Stanley Asia Limited
46/F, International Commerce Centre
1 Austin Road West
Kowloon
Hong Kong
Jefferies Hong Kong Limited*
26/F, Two International Finance Centre
8 Finance Street, Central
Hong Kong
CLSA Limited*
18/F, One Pacific Place
88 Queensway
Hong Kong
China International Capital Corporation
Hong Kong Securities Limited
29/F, One International Finance Centre
1 Harbour View Street
Central
Hong Kong
CMB International Capital Limited
45/F, Champion Tower
3 Garden Road
Central
Hong Kong
ICBC International Securities Limited
37/F ICBC Tower
3 Garden Road
Hong Kong
BOCI Asia Limited
26/F, Bank of China Tower
1 Garden Road
Central
Hong Kong
GF Securities (Hong Kong)
Brokerage Limited
27/F, GF Tower
81 Lockhart Road
Wan Chai
Hong Kong
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 163 ---
ABCI Capital Limited
11/F, Agricultural Bank of China Tower
50 Connaught Road Central
Central
Hong Kong
(* in no particular order)
Joint Lead Managers Morgan Stanley Asia Limited
46/F, International Commerce Centre
1 Austin Road West
Kowloon
Hong Kong
Jefferies Hong Kong Limited*
26/F, Two International Finance Centre
8 Finance Street, Central
Hong Kong
CLSA Limited*
18/F, One Pacific Place
88 Queensway
Hong Kong
China International Capital Corporation
Hong Kong Securities Limited
29/F, One International Finance Centre
1 Harbour View Street
Central
Hong Kong
CMB International Capital Limited
45/F, Champion Tower
3 Garden Road
Central
Hong Kong
ICBC International Securities Limited
37/F ICBC Tower
3 Garden Road
Hong Kong
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 164 ---
BOCI Asia Limited
26/F, Bank of China Tower
1 Garden Road
Central
Hong Kong
GF Securities (Hong Kong)
Brokerage Limited
27/F, GF Tower
81 Lockhart Road
Wan Chai
Hong Kong
ABCI Securities Company Limited
10/F, Agricultural Bank of China Tower
50 Connaught Road Central
Central
Hong Kong
(* in no particular order)
Capital Market Intermediaries Morgan Stanley Asia Limited
46/F, International Commerce Centre
1 Austin Road West
Kowloon
Hong Kong
Jefferies Hong Kong Limited*
26/F, Two International Finance Centre
8 Finance Street, Central
Hong Kong
CLSA Limited*
18/F, One Pacific Place
88 Queensway
Hong Kong
China International Capital Corporation
Hong Kong Securities Limited
29/F, One International Finance Centre
1 Harbour View Street
Central
Hong Kong
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 165 ---
CMB International Capital Limited
45/F, Champion Tower
3 Garden Road
Central
Hong Kong
ICBC International Securities Limited
37/F ICBC Tower
3 Garden Road
Hong Kong
BOCI Asia Limited
26/F, Bank of China Tower
1 Garden Road
Central
Hong Kong
GF Securities (Hong Kong)
Brokerage Limited
27/F, GF Tower
81 Lockhart Road
Wan Chai
Hong Kong
ABCI Capital Limited
11/F, Agricultural Bank of China Tower
50 Connaught Road Central
Central
Hong Kong
ABCI Securities Company Limited
10/F, Agricultural Bank of China Tower
50 Connaught Road Central
Central
Hong Kong
(* in no particular order)
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 166 ---
Legal Advisors to our Company As to Hong Kong and U.S. laws:
Kirkland & Ellis
26/F, Gloucester Tower
The Landmark
15 Queen’s Road Central
Hong Kong
As to PRC laws:
CM Law Firm
Rm 2805, Plaza 66 Tower 2
1366 West Nanjing Road
Shanghai
the PRC
As to PRC intellectual property laws:
JunHe LLP
26/F, HKRI Centre One
HKRI Taikoo Hui
288 Shimen Road (No. 1)
Shanghai
the PRC
As to intellectual property laws of the
United States:
Jun He Law Offices P.C.
20380 Town Center Lane
Suite 128
Cupertino, CA 95014
the United States
As to Cayman Islands laws:
Harney Westwood & Riegels
3501, The Center
99 Queen’s Road Central
Hong Kong
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 167 ---
Legal Advisors to the Joint Sponsors and
the Underwriters
as to Hong Kong and U.S. laws:
Cooley HK
35/F, Two Exchange Square
8 Connaught Place
Central
Hong Kong
as to PRC law:
Commerce & Finance Law Offices
12-14th Floor, China World Office 2
No. 1 Jianguomenwai Avenue
Beijing
the PRC
Reporting Accountant and
Independent Auditor
PricewaterhouseCoopers
Certified Public Accountants and
Registered Public Interest Entity Auditor
22/F, Prince’s Building
Central
Hong Kong
Industry Consultant Frost & Sullivan (Beijing) Inc.,
Shanghai Branch Co.
Room 2504, Wheelock Square
No. 1717 West Nanjing Road
Jing’an District, Shanghai
the PRC
Compliance Advisor First Shanghai Capital Limited
19/F., Wing On House
71 Des V oeux Road Central
Hong Kong
Receiving Bank CMB Wing Lung Bank Limited
45 Des V oeux Road Central
Hong Kong
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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--- page 168 ---
Head Offices, Registered Offices and
Principal Places of Business in the PRC
Unit 301, Building 3, Zone B
Phase III, Biopharmaceutical Industrial Park
No. 99 Jingu Road
Suzhou Industrial Park
Suzhou, Jiangsu Province
the PRC
Units 1103-1106, Building A
No. 868 Yinghua Road
Pudong New Area
Shanghai
the PRC
Principal Place of Business in Hong Kong 40/F
Dah Sing Financial Centre
248 Queen’s Road East
Wanchai
Hong Kong
Registered office in the Cayman Islands Harneys Fiduciary (Cayman) Limited
4th Floor, Harbour Place
103 South Church Street
George Town
P .O. Box 10240
Grand Cayman KY1-1002
Cayman Islands
Company’s Website www.dualitybiologics.com
(Information contained in this website does
not form part of this prospectus)
Joint Company Secretaries Ms. YUAN Jiali ( ঺Գᘆ)
Units 1103-1106, Building A
No. 868 Yinghua Road
Pudong New Area
Shanghai
the PRC
Ms. TSANG Wing Man ( ಀ጑ත)
(an associate member of The Hong Kong
Chartered Governance Institute and The
Chartered Governance Institute)
40/F
Dah Sing Financial Centre
248 Queen’s Road East
Wanchai
Hong Kong
CORPORATE INFORMATION
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--- page 169 ---
Authorized Representatives Dr. ZHU Zhongyuan (Ⴣ)
Units 1103-1106, Building A
No. 868 Yinghua Road
Pudong New Area
Shanghai
the PRC
Ms. TSANG Wing Man ( ಀ጑ත)
40/F
Dah Sing Financial Centre
248 Queen’s Road East
Wanchai
Hong Kong
Audit Committee Mr. XIE Dong (؇)Chairperson)
Mr. GAO Fengyong (ۇ)
Ms. CHUAI Shuyin ( ౣ᪣ত)
Remuneration Committee Ms. CHUAI Shuyin ( ౣ᪣ত) (Chairperson)
Mr. GAO Fengyong (ۇ)
Ms. SI Wen ( ̡˖)
Nomination Committee Dr. ZHU Zhongyuan (Ⴣ) (Chairperson)
Ms. CHUAI Shuyin ( ౣ᪣ত)
Mr. XIE Dong (؇)
Principal Share Registrar and Transfer
Agent
Harneys Fiduciary (Cayman) Limited
4th Floor, Harbour Place
103 South Church Street
P .O. Box 10240
Grand Cayman KY1-1002
Cayman Islands
CORPORATE INFORMATION
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--- page 170 ---
Hong Kong 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 bank Industrial and Commercial Bank of
China Limited, Suzhou Industrial
Park Branch
No. 1 Suzhou Avenue West
Suzhou Industrial Park
Suzhou, Jiangsu Province
the PRC
CORPORATE INFORMATION
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--- page 171 ---
The information and statistics set out in this section and other sections of this
prospectus were extracted from different official government publications, available
sources from public market research and other sources from independent suppliers, and
from the independent industry report prepared by Frost & Sullivan in connection with the
Global Offering (the “ F&S Report ”). The information from official government sources
has not been independently verified by us, the Joint Sponsors, the Joint Representatives,
the Overall Coordinators, the Capital Market Intermediaries, the Joint Global
Coordinators, the Joint Bookrunners, the Joint Lead Managers, any of the Underwriters,
any of their respective directors and advisers, or any other persons or parties involved
in the Global Offering, and no representation is given as to its accuracy.
ANTIBODY-DRUG CONJUGATES: A PRECISION TREATMENT REVOLUTION
Evolution of Disease Treatment Paradigm
The treatment landscape of major diseases, such as cancer and autoimmune diseases, has
undergone a dynamic transformation. For decades, systemic treatments, such as chemotherapy
and radiotherapy, have been the mainstays in the standard of care for cancer and other diseases.
While these treatments can be applied to a broad spectrum of cancer types, their indiscriminate
nature can damage healthy cells and often causes serious side effects, prompting the
revolutionary development of precision treatments and immunotherapies for cancer in recent
years. Immunotherapies, such as programmed cell death protein 1/ligand 1 (“ PD-(L)1 ”)
checkpoint inhibitors, have transformed the treatment landscape for cancer with improved
efficacy and better tolerability. However, these treatments still face significant limitations,
including a large population of unresponsive or resistant patients and treatment discontinuation
due to side effects.
Antibody-drug conjugates (“ ADCs ”) have emerged as one of the most promising and
fastest-growing treatment modalities, with the ability to leverage the targeting and binding
abilities of antibodies to precisely deliver cytotoxic payloads to cancer or other diseased cells.
The first ADC was approved in 2000, and 11 of the 16 marketed ADCs to date were approved
after 2019, with five ADCs achieving blockbuster status (i.e., more than US$1.0 billion in
annual sales).
Building upon earlier technologies and successes, ADCs have reached an inflection point
with their full potential ready to be unleashed. Substantial research is being conducted to
optimize each component of the ADC — the payload, linker and antibody — to explore new
formats, targets and mechanisms. These efforts aim to improve efficacy and safety of ADCs to
advance the modality towards first-line treatment and establish a new standard of care. Beyond
oncology, ADCs are a promising modality in other underserved therapeutic areas, such as
autoimmune, metabolic and cardiovascular diseases. These ongoing advancements are
propelling ADCs to new frontiers, unlocking the promise of this innovative modality to benefit
a much wider patient population.
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Cycle
Emerging Stage
 Rapid Growth Stage
 Maturity Stage
• Increasing recognition and gaining
attraction
• Rapid adoption and market expansion
• Number of competitors increases
and competitive landscape emerges
• Well-established modality
demonstrating clinical efficacy
• Seek differentiated strategies
and product offerings
Broaden the boundary of the
modality and therapy and
establish new standard
of care (“SoC”)
•
• Growing investments drive
innovations and breakthroughs
• Established recognition and
widespread adoption
• Market leaders emerge and begin to
realize economies of scale
• Focus on improving product quality
• Major breakthroughs or disruptions are
less common
Industry
Characteristics
• Gaining awareness of the
new modality and therapy
Market
Environment
Development
Stage
Gene
Therapy
Chemotherapy(3)
Decline Stage
• Market saturation and
demand decline
•M a r k e t g r o w t h
stabilizes
• Reduction in product
categories and number
of competitors
ADC(1)
• Few market competitors
• Hypothesize, generate and
test new ideas and
technologies
• Seek proof-of-concept on
new indications
Explore and identify
target market and
market proposition
•
Oligonucleotide
Cell
Therapy
Monoclonal
Antibody(2)
Notes:
(1) The global ADC market grew rapidly from US$2.0 billion in 2018 to US$10.4 billion in 2023 with a CAGR
of 38.6%, and is projected to continue its robust growth at a CAGR of 31.8% and 29.2% from 2023 to 2028
and from 2028 to 2032, respectively, and reach US$115.1 billion in 2032.
(2) The global market size of PD-(L)1 checkpoint inhibitors, being one of the major modalities of monoclonal
antibody for oncology treatment, grew from US$16.3 billion in 2018 to US$47.6 billion in 2023 with a CAGR
of 24.0%, and is expected to reach US$57.1 billion in 2032 with a CAGR of 2.0% from 2023 to 2032.
(3) The global market size of oncology chemotherapy grew from US$22.3 billion in 2018 to US$29.5 billion in
2023 with a CAGR of 5.7%, and is expected to reach US$33.2 billion in 2032 with a CAGR of 1.3% from 2023
to 2032.
Source: Literature review, Frost & Sullivan
Substantial Market Interest in ADCs
ADCs have attracted significant interest and investment in the pharmaceutical industry.
Each of the global top ten multinational corporations (“ MNCs ”) has established an ADC
presence, through in-house development or external collaboration and investment. Since 2022,
the global ADC industry has witnessed a record-breaking volume of over 20 licensing deals by
global MNCs in aggregate, with a total deal value of over US$60 billion.
Notably, China-based biopharmaceutical companies have emerged as prominent players.
As the licensors in a majority of these deals, China-based companies have exemplified strong
ADC discovery and development capabilities. Since 2022, over 20 ADC assets have been
licensed or acquired for a total deal value of over US$35 billion from China-based companies.
China-based companies and institutions also ranked second in the world in terms of the number
of ADC-related journal articles published and the number of patents granted in 2022. China’s
leading position is attributed to its robust interdisciplinary R&D capabilities. In addition, the
innovation-oriented regulatory framework, including expedited approval process, incentives to
innovative R&D and promotion of international collaboration, also supports drug innovation
and accelerates drug development in China.
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Introduction to ADC Structure and Mechanism
ADCs comprise three core components and require holistic and intricate design based on
features of each component and characteristics of the target disease. Modifications to each
component can have a substantial influence on the pharmacological properties and clinical
profiles of the ADC. The following diagrams illustrate an ADC’s structure and its mechanism
of action:
Main Structure of ADC
 Mechanism of Action of ADC
Antibody
Linker
 Cytotoxic/Payload
drug
• Once antibody of ADC is bound to the target antigens that
are specifically expressed on the cancer cells, the ADC is
endocytosed/internalized by cells to form an early endosome,
followed a maturation into late endosomes and finally fused
with lysosomes.
• The cytotoxic payloads are eventually released via either chemical
or enzyme mediated mechanism in the lysosomes, resulting in cell
apoptosis or death via targeting DNA or microtubules.
• When the payload released is permeable or transmembrane,
it may also induce bystander effect to enhance the efficacy of ADC.
Bridge between
antibody and drugs and
to control the release
of drugs inside cancer cell
Recognition of
target cancer cell
Warhead for destroying
cancer cell
Guidance system
for cytotoxic drugs
Target Antigen
Source: Literature review, Frost & Sullivan
As “guided missiles,” ADCs combine the target selectivity of antibodies and the
cancer-killing potency of cytotoxic drugs (payloads). This synergistic design potentially
reduces off-target, systemic toxicity and allows the targeted delivery of highly potent cytotoxic
drugs that would otherwise be intolerable in systemic therapies such as chemotherapies,
thereby leading to a wider therapeutic window, improved efficacy, duration of response and
overall survival in cancer patients. Notably, the achievement of bystander killing effects by
topoisomerase-based ADCs in recent years has further enhanced efficacy by enabling killing of
neighboring tumor cells that may not express the target antigen.
Evolution of ADCs
Despite their vast therapeutic potential, early generations of ADCs faced various
challenges, including intolerable toxicity and suboptimal efficacy that stymied numerous ADC
development programs from the 1980s to the 2000s. The first ADC, Mylotarg
®, was approved
by the United States Food and Drug Administration (the “ FDA”) in 2000 for the treatment of
acute myeloid leukemia. Since then, ADC technology has undergone continuous innovation,
bringing substantial improvements in stability, tolerability and efficacy. Examples include the
introduction of bystander killing effects through new payloads with better cross-cell
INDUSTRY OVERVIEW
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permeability, the evolution from chimeric antibodies to humanized antibodies, cleavable
linkers for payload release in the tumor microenvironment, and advancements in site-specific
conjugation techniques to improve therapeutic window. These technological breakthroughs
have expanded the application of ADCs from blood cancers only to a growing number of solid
tumors. Significant efforts are being made to investigate new and emerging targets with no
approved drugs, such as B7-H3 and HER3. There are also continuous efforts to optimize each
of the three ADC components for difficult-to-treat tumors with low or ultralow protein
expression, such as HER2-low breast cancer (“ BC”) and endometrial cancer (“ EC”).
The next wave ADCs are expected to leverage novel linkers and payloads, moving beyond
traditional cytotoxic agents to employ innovative molecules such as immunomodulatory
payloads. Other innovation fronts in ADC development include the exploration of novel
bispecific and multi-specific formats, and potential combination therapies with other treatment
modalities to create synergistic effects. All these advancements will pave the way for ADCs to
expand towards earlier lines of treatment and therapeutic areas beyond oncology.
The table below sets forth the details of the evolution of ADCs and representative
products and their treatment potential.
2012 and before
Treatment for
hematological malignancies
2013-2019
Treatment for solid tumor with
highly and specifically
expressed biomarker
2020-2024
Treatment for solid tumor with high
and low-biomarker expression
2000
Mylotarg®
• Acute Myeloid
Leukemia
Adcetris®
• Classical
Hodgkin
Lymphoma
2011 2013
Kadcyla
®
• HER2+ BC
Padcev®
• Urothelial Cancer (“UC”)
2019
Enhertu®
• HER2-Low BC
More ADC candidates
with low-expression
solid tumor indications
are under development
2020
2024
2022
Trodelvy®
• Metastatic Triple
Negative Breast
Cancer (“mTNBC”)
Next Wave
Potential treatment
for broader tumor types
and non-oncology
indications
• Bispecific ADC
• ADC for autoimmune
diseases
• Novel linker and
payload design
Source: FDA, NMP A, Frost & Sullivan
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Major Considerations and Challenges in ADC Design and Development
Payload design is a crucial factor to the success of an ADC drug, and involves selecting
a cytotoxic agent with the optimal potency and a mechanism of action suitable for the target
tumor type. A well-designed payload typically possesses a small molecular weight to enable
good tissue penetration, coupled with a short half-life to reduce systemic exposure and
potential off-target toxicity, while maintaining a sufficient concentration within the tumor
microenvironment to exert the desired cytotoxic effects. Payload design has been a key focus
in ADC innovation with significant improvements over the years. While traditional payloads
such as monomethyl auristatin E (“ MMAE ”) have their advantages, topoisomerase-based
inhibitors have revolutionized the ADC modality, with their ability to exert bystander killing,
high potency, effective mechanism of action and accessibility for linker attachment.
The chart below sets forth the respective potency and on-target, off-tumor toxicity
profiles of different payload designs. Topoisomerase-based payloads, such as exatecan and its
derivatives, have exhibited a favorable balance between potency and off-tumor toxicity,
delivering strong antitumor efficacy while minimizing adverse effects on healthy tissues.
10-6 10-7 10-8 10-9 10-10 10-12
Low
High
Risk of
On-target
Off-Tumor
Toxicity
SN38*
Exatecan and
its derivatives*
MMAF
MMAE
Calicheamicin
DM1
DM4
PBD
PNU
IC50 Range1
Risk of Off-Tumor Toxicity as Function of Payload Potency
Note:
(1) IC50 range represents the span of concentrations at which a substance inhibits 50% of a specific biological or
biochemical function. IC50 range is used here to measure and compare the potency of different payloads.
* Topoisomerase-based payload
Source: ENA 2022, Frost & Sullivan
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Antibody selection requires careful consideration of the target antigen’s expression
profile, internalization rate, and potential for off-target toxicity, where the chosen antibody
possesses the desired specificity and affinity to ensure efficient and targeted delivery of the
payload to the tumor cells. However, challenges remain in identifying suitable antigens with
limited expression in healthy tissues, developing antibodies with optimal pharmacokinetic and
pharmacodynamic properties, and mitigating potential immunogenicity of the antibody. In
addition, new targeting backbones, such as bispecific antibodies, are being developed to
achieve synergistic anti-tumor effects and increase tumor specificity. The complexity of
combining targets with different targeting moieties introduces new challenges in antibody
selection and engineering.
Linker design focuses on selecting a linker that is stable in circulation to minimize
premature payload release and systemic toxicity, while also enabling efficient release of the
active drug within the target cells and tissues. Linkers can be broadly categorized into
cleavable and non-cleavable linkers, chosen based on payload properties and the desired
release mechanism. For example, cleavable linkers can achieve more targeted and precise
delivery through their controlled release mechanism, whereas non-cleavable linkers are
typically more stable in circulation. Other linker design considerations include ensuring
consistent drug-to-antibody ratio (“ DAR”) through site-specific conjugation, and minimizing
the impact of the linker on the ADC’s pharmacokinetics and immunogenicity.
Global ADC Market Size
The global ADC market has witnessed rapid growth in recent years following the approval
of novel ADCs that demonstrate enhanced safety and efficacy profiles. For example, Padcev
®,
a Nectin-4 targeted ADC, and Enhertu ®, a HER2-targeted ADC, both of which received initial
FDA approval in 2019, have experienced rapid uptake and commercial success in recent years.
In 2023, Padcev
® and Enhertu ® generated global sales revenue of US$1,178.0 million and
US$2,566.0 million, respectively.
The global ADC market grew rapidly from US$2.0 billion in 2018 to US$10.4 billion in
2023 at a CAGR of 38.6% and is projected to continue its robust growth at a CAGR of 31.8%
and 29.2% from 2023 to 2028 and from 2028 to 2032, respectively, and reach US$115.1 billion
in 2032. The U.S. and China are expected to remain the largest and fastest-growing markets for
ADCs, with a CAGR of 30.9% and 72.6% from 2023 to 2028, respectively. In addition, with
the exploration of this modality in non-oncology indications, ADCs for autoimmune diseases
are expected to further enlarge the ADC market. The chart below illustrates the growth of the
global ADC market with a breakdown by major regions.
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--- page 177 ---
Global ADC Market Size and Forecast, 2018-2032E
5.15.02.0 2.8 4.1 5.5 7.9 10.4
2018 2019 2020 2021 2022 2023 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E
0.4
China U.S. ROW
Period CAGR
China1 U.S. ROW Global 2
2018-2023 N/A 41.6% 34.2% 38.6%
2023-2028E 72.6% 30.9% 26.9% 31.8%
2028E-2032E
Billion USD
34.0% 27.6% 29.5% 29.2%
30.9
6.4 8.3 11.2 15.0 19.4 24.2
39.7
51.5
25.8
6.1 7.6 10.0
13.0
16.4
20.0
34.2
46.2
13.2 17.2
23.6
31.7
41.3
51.6
66.2
86.8
115.1
9.5 12.8 17.47.25.43.70.10.1
3.1
2.3
0.01.30.9 0.7 1.4 2.3
2.3
1.8
1.51.1 4.0
3.8
Notes:
(1) China’s relatively small share in the global ADC market is primarily attributable to (i) the fewer number of
approved ADCs to date (11 in China compared to 14 in the U.S.), (ii) later market entry (first approval in 2020
in China as compared to 2000 in the U.S.), and (iii) lower pricing compared to the U.S. and EU. Despite the
above factors, China’s share in the global ADC market is projected to grow from 3.4% in 2023 to 15.2% in
2032.
(2) As the global ADC market size expands, the expected growth of the global ADC market between 2023 and
2032 is projected to slow down compared to the period between 2018 and 2023. However, it is still expected
to grow faster than other traditional treatment modalities, including chemotherapy and monoclonal antibodies.
Source: Annual Reports of Listed Medical Companies, NMP A, CDE, NRDL, MOHRSS, Frost & Sullivan
Entry Barriers
The major entry barriers for new entrants to the ADC market are set forth as follows:
 Sophisticated development process. ADC development is a challenging process
involving significant uncertainties. Many ADCs have exhibited potential in
preclinical research, but failed to perform well in clinical trials, with toxicity being
one of the main factors contributing to these failures. The nature of ADCs requires
robust and specialized data, such as drug-to-antibody ratio, in addition to a wide
range of other parameters. Such a sophisticated development process also
necessitates significant capital investment and substantial financial support, which
also poses challenges to new entrants to the ADC market.
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 Stringent and evolving regulatory oversight. The ADC market is subject to
stringent and constantly evolving regulatory oversight, with the approval process for
new ADCs often characterized by its lengthiness and high expenses. Regulatory
authorities such as the FDA and the NMPA closely evaluate the safety, efficacy and
quality of ADCs and ADC candidates through rigorous preclinical and clinical
review. The process requires substantial documentation, additional studies and
regulatory communications, making ADC development and approval time-
consuming and expensive for market players, especially new entrants.
Market Drivers and Future Trends
The growth of the ADC market is expected to be driven by the following factors:
 Expanding patient base with unmet needs. The global cancer incidence reached
20.8 million cases in 2023, and is projected to increase to 25.5 million cases in 2032.
Incidence is growing in major tumor types currently covered by approved ADCs,
including certain subtypes of BC and non-small cell lung cancer (“ NSCLC ”). Other
cancers, such as EC, ovarian cancer ( “OC”), small-cell lung cancer (“ SCLC ”) and
castration-resistant prostate cancer (“ CRPC ”), are also growing in global incidence.
Due to the lack of effective treatments, as well as the occurrence of drug resistance
and relapse, the five-year survival rate for cancer remains low, highlighting the
demand for novel therapies to improve cancer prognosis and outcome. Notably,
ADCs have emerged as a promising upgrade to chemotherapy in cancer treatment,
as they combine the specificity of antibodies with the potent cell-killing ability of
cytotoxic drugs, representing a significant market opportunity.
 Broadened application through technology advances. Significant investments are
being devoted to cancer research and drug development, with the goal to further
elucidate disease biology and discover targeted cancer treatments that improve
patient outcomes. In particular, ongoing ADC research and development on novel
payloads can potentially yield new designs that improve the therapeutic effects of
this modality and reduce toxicity that limits the use of some marketed ADCs. To
date, there are over 100 ADC candidates under clinical development globally
targeting new indications not covered by approved ADCs. These efforts will drive
ADCs towards becoming a backbone cancer therapy and their expansion into other
therapeutic areas.
 Dynamic collaboration among market players. There has been a surge of
collaboration and licensing deals in the ADC industry, with large MNCs increasing
investments into this field and smaller biotechnology companies contributing
significantly to the R&D of ADC candidates. Biotechnology companies often
leverage their innovative capabilities and expertise to conduct initial exploratory
work and proof-of-concept studies, while collaborating with MNCs provides
substantial technical, financial and regulatory support to expedite further
development and commercialization of promising ADC candidates. Meanwhile,
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in-licensing components for innovative drug development has emerged as a common
practice, especially for complex therapeutics like ADCs. The enhanced collaboration
among biotechnology companies to advance the R&D and commercialization of
ADCs also contributes substantially to the growth of the ADC market. For example,
in June 2024, MabCare Therapeutics entered into a license agreement with Day One
Biopharma for a PTK7 ADC candidate. In December 2024, our Company entered
into a collaboration and license agreement with Avenzo regarding the R&D and
commercialization of an EGFR/HER3 BsADC candidate. Overall, synergistic
collaboration models have become increasingly instrumental in bringing novel
candidates to the market.
The future development of ADCs is likely to witness the following trends:
 Novel payloads and linkers . Although traditional payloads have been proven to be
effective, there is a growing focus on exploring novel payloads to expand the range
of treatable cancer types and overcome drug resistance, as more patients are treated
with, and acquire resistance to, existing ADCs. In addition, beyond the site-specific
conjugation methods of existing ADCs, researchers are exploring more sophisticated
linker designs aimed to further improve payload delivery and release while reducing
off-target toxicity.
 Wider coverage of targets and expression levels . Expression level refers to the
quantity of specific targets present on the surface of cells. Many solid tumors
express low or heterogeneous levels of targets, limiting the applicability of existing
ADCs that focus on tumors with high expression levels of targets. Research is
underway to develop ADC candidates effective against solid tumors with low
expression. For example, recent advancements in ADC design, including the
development of topoisomerase-based payloads, have resulted in successful
applications of HER2 ADCs for HER2-low BC patients. Novel targets such as HER3
and B7-H3 have also emerged, drawing significant industry attention. Research into
these emerging targets aims to broaden the landscape of tumor antigens that can be
leveraged for the selective delivery of cytotoxic payloads.
 Novel ADC formats. New formats such as bispecific and multi-specific ADCs are a
rising trend in the development of next-generation ADCs. Compared to
monospecific ADCs, BsADCs can potentially target and kill tumor cells more
precisely by simultaneously targeting two different antigens to overcome tumor
heterogenicity, and reduce the risk of off-target toxicity. Some BsADCs can also
harness the patient’s own immune system through simultaneous immune-modulation
to achieve synergistic anti-tumor effects. Moreover, BsADCs can potentially
overcome drug resistance to monospecific ADCs by blocking escape pathways,
making them more promising for extended duration of response.
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 Expansion to non-oncology therapeutic areas. With technological advances in
progress, ADCs are expected to cover a wider range of cancer types as well as
expand to non-oncology areas such as autoimmune, metabolic and cardiovascular
diseases. With the ability to minimize off-target effects and systemic toxicity
through targeting specificity, ADCs have become a promising option for these
chronic, non-oncology conditions that require treatments with improved safety
profiles. This expansion is likely to bring new market potential for ADCs in the near
future.
 Combination with other treatment modalities and expansion of treatment lines.
The mechanism of action of ADCs is highly synergistic with other treatment
modalities to potentiate tumor cell killing. Combination strategies have shown to be
crucial in improving efficacy and promising as first-line treatments for a broader
patient population. Notably, a strong biological rationale supports the investigation
of combining ADCs with IO to overcome the occurrence of resistance and improve
treatment outcomes for cancer patients. ADCs interact with cancer cells and immune
cells through mechanisms such as immunogenic cell death, antibody-dependent cell
mediated cytotoxicity and dendritic cell activation, leading to synergistic effects
when combined with immunotherapies such as immune checkpoint inhibitors
(“ICIs ”). Combination therapies of ADCs with tyrosine kinase inhibitors (“ TKIs ”)
have also shown promise in clinical studies to enhance anti-tumor efficacy.
THE CANCER DRUG MARKET
Cancer is the leading cause of mortality worldwide, resulting in approximately 10 million
deaths globally each year. Global cancer incidence reached 20.8 million in 2023 and is
expected to reach 25.5 million in 2032. As illustrated in the charts below, lung cancer, BC and
colorectal cancer (“ CRC”) were the top three cancers by global incidence in 2023, with 2,552
thousand cases, 2,408 thousand cases and 2,032 thousand cases, respectively.
Thousands Top 10 Cancers by Incidence Globally, 2023
Lung Breast Colorectum Prostate Stomach Liver Thyroid Lymphoma Cervix uteri Bladder
Thousands Top 10 Cancers by Incidence in the U.S., 2023
300.6 288.3
238.3
153.0
97.6 89.4 82.3 81.8 66.2 64.1
Breast Prostate Lung Colorectum Melanoma
of skin
Lymphoma Bladder Kidney Uterus Pancreas
Thousands Top 10 Cancers by Incidence in China, 2023
1,090.1
531.2 476.3 376.0 369.0 365.1 231.0 151.6 139.7 122.3
Lung Colorectum Thyroid Liver Stomach Breast Esophagus Cervix uteri Prostate Pancreas
2,552.2 2,408.0 2,031.5
1,551.5
995.5 889.2 833.0 670.8 639.7 621.8
Source: Globocan, IARC, NCCR, Frost & Sullivan
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Global Cancer Drug Market Size
In line with the continuous growth of cancer incidence, the global cancer drug market has
expanded rapidly in recent years. The global cancer drug market grew from US$128.1 billion
in 2018 to US$228.9 billion in 2023 at a CAGR of 12.3% and is expected to continue its growth
at a CAGR of 9.5% and 7.8% from 2023 to 2028 and 2028 to 2032, respectively, and reach
US$486.8 billion in 2032.
Global Cancer Drug Market, 2018-2032E
60.2 67.8 70.5 84.7 95.5 105.0 118.8 133.9
101.2
149.1
106.1
164.0
112.1
179.5
117.5
195.0
124.2
209.9
133.0
225.6
142.7
242.2
153.2
44.1 49.2 51.2
61.2 74.9 89.7 97.0
128.1 143.5 150.3
181.7
205.1
228.9
253.8
279.2
305.8
333.3
360.6
389.5
419.8
452.2
486.8
2018 2019 2020 2021 2022 2023 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E
28.6 35.823.8 26.4 34.7 34.1 38.0 44.1 50.6 57.2 63.6 70.2 77.0 84.0 91.4
China U.S. ROW
Billion USD
Period CAGR
China U.S. ROW Global
2018-2023 7.5% 11.8% 15.2% 12.3%
2023-2028E 13.2% 11.3% 5.5% 9.5%
2028E-2032E 9.5% 7.8% 6.9% 7.8%
Source: Frost & Sullivan
Despite the advancement of various cancer treatment modalities in recent years, there
remains an unmet need for novel, differentiated therapies that can enhance the overall survival
of cancer patients. These unmet needs have grown even more pressing as the patient population
continues to expand.
GLOBAL HER2 ADC MARKET
Overview
HER2 is a cell surface receptor protein within the HER family that plays a key role in
regulating cellular growth, division and survival. Upon activation by ligand binding or
overexpression, HER2 dimerizes with other HER family members, leading to the activation of
downstream signaling cascades such as the PI3K/AKT and MAPK/ERK pathways. These
pathways promote cell proliferation, inhibit apoptosis, and enhance cell migration and
invasion. HER2 is expressed in normal tissues at a low level, but its aberrant activation through
overexpression in tumor cells promotes their growth and survival, thus driving the
development of various types of cancers. HER2 has become a well-established cancer drug
target with successful HER2-targeted therapies in different modalities, among which HER2
ADC represents one of the most successful strategies.
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While HER2 is frequently overexpressed in tumor cells, expression levels can vary,
requiring different therapeutic strategies. The table below sets forth the percentage of different
tumor types with HER2+ and HER2 low expression levels.
Breast cancer
Endometrial cancer
Ovarian cancer
Colorectal cancer
Gastric cancer
Esophageal cancer
Non-small cell lung cancer
17–30%
20–30%
5–6%
9–38%
7–22%
7–23%
45–55%
47–53%
60–70%
45–50%
30–35%
N/A
N/A
Cancer HER2+
(IHC 3+ or IHC 2+ /ISH +)
HER2 Low
(IHC 2+/ISH- or IHC 1+)
15–30%
Sources: Literature review, Frost & Sullivan
Addressable Market Size
The first ADC targeting HER2 in the world, Kadcyla ®, was approved in 2013. As shown
in the chart below, the global HER2 ADC market increased to US$4.8 billion in 2023,
representing a CAGR of 37.1% from 2018. The global HER2 ADC market is projected to
increase at a CAGR of 30.8% and 16.8% from 2023 to 2028 and from 2028 to 2032,
respectively, and reach US$34.5 billion in 2032. The chart below sets forth the growth of the
global HER2 ADC market with a breakdown by major regions.
Global HER2 ADC Market Size, 2018-2032E
China U.S. ROW
2.33.2
3.4
4.2 5.4 6.8 8.2 9.8 11.5
13.2
15.1
4.5
5.7
7.1
8.6
10.1
11.6
13.1
14.5
1.0 1.4 2.1 2.7 3.5
0.4
4.8
7.0
9.3
12.0
15.1
18.5
22.2
26.1
30.3
34.5
2018 2019 2020 2021 2022 2023 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E
3.0 3.9 5.0
Period CAGR
China U.S. ROW Global
2018-2023 NA 44.5% 29.1% 37.1%
2023-2028E 46.0% 28.9% 30.4% 30.8%
2028E-2032E
Billion USD
30.7% 16.2% 14.0% 16.8%
0.6 0.9 1.3 1.7
Source: Frost & Sullivan
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Market Opportunities of HER2 ADCs
Breast Cancer
BC is the second largest cancer type in the world with incidence of approximately 2,408.0
thousand cases globally and 365.1 thousand cases in China in 2023. HER2 is expressed in
approximately 70% of BC cases, with expression levels varying from high (IHC 3+ or IHC
2+/ISH+) to low (IHC 2+/ISH- or IHC 1+). The table below sets forth the classification of
HER2 expression by IHC scores and their respective percentages in total BC cases.
HER2 Positive
(IHC 3+ or IHC 2+/ISH+)
HER2 Low
(IHC 2+/ISH- or IHC 1+)
HER2 Null
(IHC 0)
~15-30%
~45-55%
~15-40%
Classification of HER2 Expression in BC Patients
The global BC drug market grew from US$26.8 billion in 2018 to US$38.2 billion in 2023
at a CAGR of 7.4%, and is expected to increase to US$56.1 billion and US$71.2 billion in 2028
and 2032, respectively, representing a CAGR of 8.0% from 2023 to 2028 and 6.1% from 2028
to 2032. The chart below sets forth the growth of the global BC drug market with a breakdown
by HER2 expression level.
Global Breast Cancer Drug Market Size, 2018-2032E
7.36.76.2
7.6 8.0 8.6
12.5 13.4 14.5 15.7 17.0 18.3 19.6
8.5 9.3 10.3 11.0
15.915.014.313.112.1
17.2 18.6
9.1
20.2 22.0 23.9 25.9 27.9 29.9 31.7 33.59.8 10.5 11.2
11.9
12.7
13.3 14.1 14.7
26.8 29.2 31.8 33.6 35.6 38.2 41.2 44.5
48.2
52.1
56.1
60.2
64.1
67.8 71.2
2018 2019 2020 2021 2022 2023 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E
20.9 22.0 23.0
Billion USD
11.6
HER2-null BC HER2-low BC HER2+ BC
Period
CAGR
HER2-null BC
2018-2023
2023-2028E
2028E-2032E
6.6%
6.9%
5.4%
HER2-low BC
7.3%
8.5%
6.7%
HER2+ BC
8.0%
8.0%
5.9%
Total
7.4%
8.0%
6.1%
Source: Frost & Sullivan
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The current treatment landscape of BC primarily consists of chemotherapy, monoclonal
antibodies (“ mAbs ”), immune checkpoint inhibitors such as PD-(L)1 inhibitors and small
molecule inhibitors such as CDK4/6 inhibitors, as well as ADCs which represent a novel
treatment modality.
As of the Latest Practicable Date, Kadcyla
® and Enhertu ® were the only two HER2 ADCs
indicated for BC approved both in the U.S and in China. Traditionally, HER2 ADCs were
designed to target and were believed to be effective only against HER2+ BC. However, HER2+
BC patients account for less than one third of the total BC patient population, leaving the
HER2-low and HER2-null population untreated. Recent advancements in ADC design,
including the development of topoisomerase-based payloads, have resulted in successful
applications of HER2 ADCs for HER2-low BC patients. As of the Latest Practicable Date, only
one HER2 ADC, Enhertu
®, was approved for HER2-low BC and only for patients who have
received a prior chemotherapy in the metastatic setting or developed disease recurrence during
or within six months of completing adjuvant chemotherapy, highlighting an unmet need among
the large HER2-low or null patient population.
The charts below set forth the subsets of BC patients as well as the treatment paradigm
for BC in China and the U.S.
Treatment Paradigm for BC in China
HER2+ BC
BC
HER2-Low BC HER2-Null BC
Trastuzumab-resistantTrastuzumab-sensitive TKI-resistant
• THP
• TH + Pyrotinib
• Pyrotinib +
Capecitabine
• Trastuzumab
Deruxtecan
• N/A
• TXH
• H + Chemotherapy
• Trastuzumab
Emtansine
Emtansine
• HP + Chemotherap y
• Tr astuzumab
Deruxtecan
• Pyrotinib +
Capecitabine
• HP + Chemotherapy
• Neratinib +
Capecitabine
• Margetuximab +
Chemotherapy
• Lapatinib +
Capecitabine
• TKI + Chemotherapy
• HP + Chemotherapy
• Another TKI +
Chemotherapy
HR+/HER2-Low HR-/HER2-Low
• ET + CDK4/6i
• Chemotherapy
• Trastuzumab
Deruxtecan
• Other ET
• Sacituzumab
Govitecan
• Chemotherapy
 ± Immunotherapy is
recommended as
first-line treatment
• ADCs such as
Trastuzumab Deruxtecan
 or Sacituzumab
Govitecan are
recommended as the first
choice of subsequent
treatment
Level I
recommendation
Level II
recommendation
Level III
recommendation
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Treatment Paradigm for BC in the U.S.
HER2+ BC
BC
HER2-Low BC HER2-Null BC
HR+/HER2-Low HR-/HER2-Low
First Line
Disease
Progression
Second Line
Fourth Line &
beyond
Disease
Progression
• Pertuzumab + Trastuzumab + Docetaxel
• Pertuzumab + Trastuzumab + Paclitaxel
• Trastuzumab + Docetaxel/Vinorelbine
• Trastuzumab + Paclitaxel ± Carboplatin
• Capecitabine + Trastuzumab/Lapatinib
• Neratinib + Capecitabine
• Margetuximab + Chemotherapy
• Targeted Therapy Options
• Trastuzumab Deruxtecan
• CDK4/6i + ET (AI or
Fulvestrant)
• Chemotherapy +
Pembrolizumab
• Chemotherapy
• Olaparib/Talazoparib
• Alpelisib + ET
• Olaparib/Talazoparib
• Elacestrant
• Fulvestrant/Exemestane +
Everolimus
• Chemotherapy
• Trastuzumab Deruxtecan
• Sacituzumab Govitecan
• Olaparib/Talazoparib
• Chemotherapy
• Trastuzumab Deruxtecan
• Sacituzumab Govitecan
• Trastuzumab Emtansine
• Tucatinib + Trastuzumab + CapecitabineThird Line
Disease
Progression
• Trastuzumab Deruxtecan
• Sacituzumab Govitecan• Chemotherapy
• Chemotherapy
• Trastuzumab Deruxtecan
• Sacituzumab Govitecan
Note: Our Group’s DB-1303 is being investigated as (i) a potential second-line (or later) treatment for HER2+ BC,
with first-line potential to treat this patient group in combination with pertuzumab, and (ii) a potential
treatment for chemo naïve HER2-low BC patients. Our Group’s DB-1310 is being investigated as a potential
treatment for HER2+ BC patients with prior Enhertu treatments.
Source: CSCO 2024, NCCN 2024, A review of treatment options in HER2-low breast cancer and proposed treatment
sequencing algorithm, Frost & Sullivan
HER2-low BC
HER2-low BC is the most prevalent subtype of BC, accounting for approximately 50%
of total BC cases. Global incidence of HER2-low BC increased from 1,044.4 thousand cases
in 2018 to 1,204.0 thousand cases in 2023, and is projected to reach 1,597.9 thousand cases by
2032. Our Group’s DB-1303 is being investigated as a potential treatment for chemo naïve
HER2-low BC patients. Global incidence of chemo naïve HER2-low BC patients increased
from 241.9 thousand cases in 2018 to 293.9 thousand cases in 2023 and are projected to reach
437.1 thousand cases in 2032.
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The global HER2-low BC drug market increased from US$12.1 billion in 2018 to
US$17.2 billion in 2023 at a CAGR of 7.3%, and is expected to increase to US$25.9 billion
and US$33.5 billion in 2028 and 2032, respectively, representing a CAGR of 8.5% from 2023
to 2028 and 6.7% from 2028 to 2032.
In China, for HR+/HER2-low BC patients who have not undergone CDK4/6 inhibitor
treatment, endocrine therapies (“ ETs”) with CDK4/6 inhibitor are recommended as level I
treatment option. For patients with prior CDK4/6 inhibitor treatment, trastuzumab deruxtecan
(Enhertu
®, HER2 ADC), chemotherapy and other ET-based therapies are recommended as level
II treatment options. Sacituzumab govitecan (Trodelvy ®, TROP2 ADC) is recommended as
level III treatment. For HR-/HER2-low BC patients, chemotherapy with or without
immunotherapy is recommended as first-line treatment. ADCs such as trastuzumab deruxtecan
or sacituzumab govitecan are recommended as the first choice of subsequent treatment.
In the U.S., for hormone receptor positive (“ HR+”)/HER2-low BC patients, ET-based
therapy with CDK4/6 inhibitors is recommended as first-line treatment. Second-line treatments
include targeted therapies such as alpelisib, olaparib and talazoparib, and estrogen receptor
degrader such as elacestrant, which are recommended based on driver mutations status.
Chemotherapy is also used in second-line or later settings for patients with imminent organ
failure or rapid progressive disease. Trastuzumab deruxtecan and sacituzumab govitecan are
used in third-line or later settings. For hormone receptor negative (“ HR-”)/HER2-low BC
patients, chemotherapy with or without pembrolizumab can be considered as first-line
treatment. Trastuzumab deruxtecan and sacituzumab govitecan are recommended to be used in
the second-line setting or later.
The current treatment paradigm for HER2-low BC has significant limitations. ETs, such
as aromatase inhibitors and a selective estrogen receptor degrader, represent the cornerstone of
standard first-line and second-line treatment options for advanced HER2-low BC in China and
the U.S. However, the recurrence rate after using ETs is approximately 40-50%. Limited
effective treatment options are available for recurrent patients, leaving a need for effective
non-ET-based treatment.
HER2+ BC
HER2+ BC is an aggressive type of BC, representing approximately 15-30% of total BC
cases. Up to 10% of HER2+ BC patients present with late-stage tumors that are challenging to
treat at the time of diagnosis, and 20% of early-stage patients eventually develop advanced
disease. The global incidence of HER2+ BC increased from 470.0 thousand cases in 2018 to
541.8 thousand cases in 2023 and is expected to reach 719.0 thousand cases in 2032. Our
Group’s DB-1303 is being investigated as a potential second-line (or later) treatment for
HER2+ BC, with first-line potential to treat this patient group in combination with pertuzumab.
Global incidence of HER2+ BC patients requiring first-line treatment increased from 172.8
thousand cases in 2018 to 200.4 thousand cases in 2023 and are projected to reach 264.8
thousand cases in 2032. Global incidence of HER2+ BC patients requiring second-line (or
later) treatment increased from 124.4 thousand cases in 2018 to 147.3 thousand cases in 2023
and are projected to reach 201.8 thousand cases in 2032.
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The global HER2+ BC drug market increased from US$8.5 billion in 2018 to US$12.5
billion in 2023 at a CAGR of 8.0%, and is expected to increase to US$18.3 billion and US$23.0
billion in 2028 and 2032, respectively, representing a CAGR of 8.0% from 2023 to 2028 and
5.9% from 2028 to 2032.
In China, treatments for HER2+ BC are generally categorized based on three patient
types: trastuzumab-sensitive patients, trastuzumab-resistant patients and TKI-resistant
patients. For trastuzumab-sensitive patients, level I recommended treatments include (i)
combination therapy of docetaxel, trastuzumab and pertuzumab, (ii) combination therapy of
docetaxel and trastuzumab plus pyrotinib. Level II recommended treatments include (i)
combination therapy of docetaxel, capecitabine and trastuzumab, and (ii) trastuzumab with
chemotherapy. Level III recommended treatments include (i) pyrotinib plus capecitabine, and
(ii) combination therapy of trastuzumab and pertuzumab plus chemotherapy. For trastuzumab-
resistant patients, trastuzumab deruxtecan (Enhertu
®, HER2 ADC) is recommended as a level
I treatment option, and trastuzumab emtansine (Kadcyla ®, HER2 ADC) as a level II treatment
option. For TKI-resistant patients, trastuzumab deruxtecan and trastuzumab emtansine are also
recommended as level II treatment options.
In the U.S., for recurrent unresectable HER2+ BC eligible for HER2 mAb treatment,
first-line treatments comprise taxane-based chemotherapy in combination with pertuzumab and
trastuzumab (HER2 mAbs) and second-line options include trastuzumab deruxtecan.
Combination therapies such as tucatinib and trastuzumab plus capecitabine, and trastuzumab
emtansine (Kadcyla
®, HER2 ADC) are recommended in third-line or later settings.
With the approval of effective treatments such as HER2 ADCs in recent years, HER2+ BC
patients have experienced increased progression free survival (“ PFS”) and overall survival
(“OS”). However, there is still a risk of acquired resistance and need for safer treatments for
long-term use. Approved HER2 ADCs, Kadcyla ®, for example, carry a black box warning
issued by the FDA for hepatic, cardiac and embryo-fetal toxicities, indicating the need for
future improvements in safety profiles of HER2 ADCs.
Endometrial Cancer
Endometrial cancer is one of the most common gynecological cancers in the world. As
one of the fastest growing cancers in terms of incidence, new cases of EC increased from 343.9
thousand in 2018 to 401.7 thousand in 2023 and are projected to reach 494.1 thousand in 2032.
While EC has traditionally been more prevalent in post-menopausal women, there is a growing
incidence in younger women, indicating increasing medical needs. The five-year survival rate
for EC patients with advanced, metastatic or recurrent disease is estimated at only 18%.
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HER2 overexpression is reported in 17-30% of total EC cases and HER2 low-expression
is reported in 47-53% of total EC cases. Our Group’s DB-1303 is being investigated as a
potential second-line (or later) treatment for HER2-expressing EC patients with combination
potential to expand into earlier treatment lines. Global incidence of HER2-expressing EC
patients requiring first-line treatment increased from 60.1 thousand cases in 2018 to 70.1
thousand cases in 2023 and are projected to reach 84.5 thousand cases in 2032. Global
incidence of HER2-expressing EC patients requiring second-line (or later) treatment increased
from 44.5 thousand cases in 2018 to 52.1 thousand cases in 2023 and are projected to reach
63.2 thousand cases in 2032.
The global EC drug market grew from US$3.4 billion in 2018 to US$5.3 billion in 2023
at a CAGR of 9.1%, and is expected to increase to US$9.0 billion and US$12.7 billion in 2028
and 2032, respectively, representing a CAGR of 11.2% from 2023 to 2028 and 8.9% from 2028
to 2032. The chart below sets forth the growth of the global EC drug market.
Global Endometrial Cancer Drug Market Size, 2018-2032E
3.4 3.7 3.9 4.3 4.8 5.3 6.0 6.7 7.4
8.2
9.0
9.9
10.8
11.7
12.7
2018 2019 2020 2021 2022 2023 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E
Billions USD
Period CAGR
2018-2023 9.1%
2023-2028E
2028E-2032E
11.2%
8.9%
Source: Frost & Sullivan
The current treatment landscape of EC primarily consists of chemotherapy, targeted
therapies such as TKIs, hormone therapies, immune checkpoint inhibitors such as PD-(L)1
inhibitors, as well as ADCs which represent a novel treatment modality.
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The charts below set forth the treatment paradigm for EC in China and the U.S.
Treatment Paradigm for EC in China
First Line
Disease
Progression
Second
Line &
beyond
EC
Level I recommendation
• Pembrolizumab
 + Lenvatinib
Level I recommendation
• Carboplatin + Paclitaxel
Level II recommendation
• Carboplatin + Paclitaxel + Pembrolizumab
• Carboplatin + Paclitaxel + Trastuzumab
• Carboplatin + Paclitaxel + Bevacizumab
• Carboplatin + Docetaxel
• Pembrolizumab + Lenvatinib
• Pembrolizumab
Level III recommendation
• Carboplatin + Paclitaxel
+ Trastuzumab
Level II recommendation
• Ifosfamide + Paclitaxel
• Cisplatin + Ifosfamide
• Pembrolizumab
• Tislelizumab
• Envafolimab
• Serplulimab
• Pucotenlimab
Level III recommendation
• Cisplatin + Doxorubicin
• Cisplatin + Doxor ubicin + Paclitaxel
• Carboplatin + D oxorubicin liposomes
• Ifosfamide
• Cisplatin
• Carboplatin
• Bevacizumab
• Topotecan
• Albumin-bound paclitaxel
Treatment Paradigm for EC in the U.S.
EC
First Line
Disease
Progression
Second Line &
beyond
• Carboplatin + Paclitaxel
• Carboplatin + Paclitaxel + Pembrolizumab
• Carboplatin + Paclitaxel + Dostarlimab
• Carboplatin + Paclitaxel + Trastuzumab (For HER2+
uterine serous carcinoma and HER2+ carcinosarcoma)
• Lenvatinib + Pembrolizumab (For pMMR tumors)
• Cisplatin + doxorubicin
• Cisplatin
• Carboplatin
• Doxorubicin
• Liposomal doxorubicin
• Paclitaxel
• Albumin-bound paclitaxel
• Topotecan
• Bevacizumab
• Temsirolimus
• Cabozantinib
• Docetaxel
• Ifosfamide + Paclitaxel
(for carcinosarcoma)
• Trastuzumab deruxtecan
(For HER2 + tumors)
Note: Our Group’s DB-1303 is being investigated as a potential second-line (or later) treatment for HER2-
expressing EC patients with combination potential to expand into earlier treatment lines.
Source: CSCO 2024, NCCN 2024, Frost & Sullivan
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In China, systemic therapy for recurrent and metastatic EC use carboplatin with paclitaxel
as level I recommended treatment. Level II treatment options include (i) combination therapies
of carboplatin with paclitaxel plus trastuzumab or bevacizumab, and (ii) combination therapy
of carboplatin with docetaxel. In second-line setting, level I recommended treatment options
include pembrolizumab plus lenvatinib.
In the U.S., first-line treatment options for recurrent disease include (i) combination
therapy of carboplatin and paclitaxel with or without pembrolizumab or dostarlimab, (ii)
combination therapy of carboplatin and paclitaxel with or without trastuzumab for HER2+
patients. Second-line treatment options include (i) combination therapy of cisplatin and
doxorubicin with or without paclitaxel, (ii) combination therapy of cisplatin with gemcitabine,
(iii) monotherapy of cisplatin, carboplatin or doxorubicin and others.
The current treatment paradigm for EC has significant limitations. For patients not
suitable for total hysterectomy, traditional drug treatments have substantial side effects. In
addition, a significant percentage of patients develop advanced and recurrent disease after
first-line treatment, and have limited response to second- or third-line treatment.
As of the Latest Practicable Date, no HER2 ADC had been approved for EC across HER2-
expression levels globally, and DB-1303 was the only HER2 ADC candidate in phase 3 clinical
development or beyond for EC patients across HER2 expression levels.
Competitive Landscape
As of the Latest Practicable Date, there were two HER2 ADCs approved both in the U.S.
and in China, namely Enhertu
® and Kadcyla ®, and one additional approved in China, Aidixi ®.
As of the same date, there were three HER2 ADCs (including Enhertu ®) in phase 3 clinical
development or beyond under global multi-regional clinical trials (“ MRCTs”). The following
tables illustrate the competitive landscape of marketed HER2 ADCs and HER2 ADC in phase
2 clinical development or beyond.
Marketed HER2 ADCs Globally
Brand Name
(Chemical Name;
Code Name)
Company Indications Treatment
Line
FDA First
Approval
NMPA
First
Approval
Global Sales
in 2023
Kadcyla®
(Ado-trastuzumab
emtansine; T-DM1)
Roche
HER2+ BC ≥2L 2013.02 2021.06 US$2,188.1
millionHER2+ Early BC Adjuvant 2019.05 2020.01
Enhertu®
(Trastuzumab
deruxtecan;
DS-8201)
Daiichi
Sankyo/
Astra-
Zeneca
HER2+ BC ≥3L 2019.12 N/A
US$2,566.0
million
HER2+ GC or GJA
≥2L
2021.01 2024.08
HER2+ BC 2022.05 2023.02
HER2-Low BC 2022.08 2023.07
HER2m NSCLC 2022.08 N/A
HER2+ Solid Tumors
HR+/HER2-Low or
HER2-Ultralow BC
2024.04 N/A
Aidixi®
(Disitamab vedotin;
RC48)
RemeGen
HER2-Overexpressing GC ≥3L
N/A
2021.06
N/A2
US$4,148/
100mg
US$2,967/
100mg
RMB3,800/
60mg1
Yes
No
Yes
100%
100%
N/A
Not available
2033 (US)
2033-2035
(China and EU)
2034 (China)
2034 (US)
HER2-Overexpressing UC ≥2L 2022.01
Price NRDL
Inclusion
U.S.
Insurance/
Assistance
Program
Coverage
Patent
Expiry
Date
2025.01 N/A
Notes:
(1) Represents price after medical insurance reimbursement.
(2) Sales revenue of Aidixi
® is not publicly available.
Sources: FDA, NMP A, Drug.com, annual reports, Frost & Sullivan
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HER2 ADCs under Global MRCTs
(Phase 2 or beyond)
Drug Name Indications Phase of TrialCompany First Post Date3 Location
DS-82011 Daiichi Sankyo
/AstraZeneca
NSCLC Harboring HER2 Exon 19 or 20
Mutations Phase 3 2021-09 Global
Biliary Tract Cancer Phase 3 2024-06 Global
HER2-Low or HER2- Null BC Phase 3 2024-09 Global
HER2+, pMMR EC Phase 3 2024-11 Global
HER2-Overexpressing CRC Phase 2 2021-02 Global
HER2-Expressing Tumors, incl. EC Phase 2 2020-07 Global
DB-1303/BNT3234
HR+/HER2-Low BC Phase 3
Our Group
/BioNTech
2023-08 Global
HER2-Expressing EC Phase 3 2024-04 Global
RC48
HER2-Expressing UC Phase 2
RemeGen
/Seagen
2021-05 Global
ARX788 HER2+ BC Phase 2Ambrx/Novo
Codex 2021-04 Global
DX126-262 HER2+ BC Phase 2DAC Biotech 2021-08 Global
HER2-Expressing Solid Tumors, incl. EC Phase 2 2023-08 Global
SYD985
HER2+ BC NDA2
Byondis
2022-07 Global
HER2-Expressing EC Phase 2 2019-12 Global
Notes:
(1) DS-8201 (Enhertu ®, trastuzumab deruxtecan), first approved by the FDA in December 2019 for HER2+ BC,
is currently under clinical development for new indications.
(2) In May 2023, FDA issued a complete response letter to Byondis on SYD985, which requested additional
information that will require additional time and resources that extend beyond the current evaluation period.
(3) First post date is the date on which the study record was first published on ClinicalTrials.gov or CDE’s
website, which may be different from the date on which a trial is initiated.
(4) DB-1303/BNT323 obtained Fast Track and Breakthrough Therapy Designations from the FDA in January and
December 2023, respectively, and Breakthrough Therapy Designation from the NMPA in March 2024 for the
treatment of advanced EC in patients who progressed on or after treatment with immune checkpoint inhibitors.
For details on the requirements of Fast Track and Breakthrough Therapy Designations, please refer to
“Regulatory Overview — PRC Regulation — Regulations on Pharmaceutical Product — Accelerated Approval
for Clinical Trial and Registration” and “Regulatory Overview — Overview of Laws and Regulations in the
United States — Laws and Regulations in Relation to New Drug — Expedited Development and Review
Programs.”
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Other HER2 ADCs under Clinical Development
(Phase 2 or beyond)
Drug Name Indications Phase of Trial Company First Post Date1 Location
A166 HER2+ BC NDAKelun-Biotech 2023-05 China
DS-8201
GC NDA
Daiichi Sankyo/
AstraZeneca
2023-12 China
NSCLC NDA 2024-02 China
HER2-Overexpressing Solid Tumors Phase 2 2024-03 China
RC48
HER2-Low BC Phase 3
RemeGen
2020-05 China
HER2-Overexpressing GC Phase 3 2021-01 China
HER2-Expressing UC Phase 3 2022-03 China
HER2+ BC Phase 2/3 2018-04 China
HER2-Overexpressing BTC Phase 2 2020-04 China
HER2-Expressing Gynecological Malignancies Phase 2 2021-07 China
Muscle-Invasive Bladder Cancer Phase 2 2022-03 China
Cervical Cancer Phase 2 2023-12 China
SHR-A1811
HER2+ BC Phase 3
Hengrui
Pharmaceuticals
2022-06 China
HER2-Low BC Phase 3 2023-04 China
HER2+ GC or GJA Phase 3 2023-11 China
2023-12 ChinaCRC Phase 3
HER2m NSCLC Phase 3 2024-05 China
Epithelial Ovarian, Fallopian Tube,
or Primary Peritoneal Cancer Phase 3 2025-02 China
HER2+ BTC Phase 2 2025-02 China
HER2+ BC Phase 2/3 2021-05 China
HER2-Low BC Phase 2 2021-02 China
HER2+/HER2-Low GC or GJA Phase 2 2021-11 China
NSCLC Phase 2 2022-01 China
RAS/BRAF Wild-Type HER2+ CRC Phase 2 2022-01 China
HER2-Expressing GC Phase 2 2022-09 China
HER2-Expressing OC Phase 2 2021-03 China
HER2-Expressing GC Phase 2 2021-04 China
MRG002
HER2+ UC Phase 3
Miracogen
2023-01 China
FS-1502
HER2+ BC Phase 3
Fosun Pharma
2023-02 China
DP303c
HER2+ BC Phase 3
CSPC Group
2023-06 China
HER2-Low BC Phase 3
JSKN003 Alphamab
2023-10 China
HER2-IHC 0 BC Phase 2 2024-03 China
HER2- BC Phase 2 2024-06 China
HER2 Gene Abnormality NSCLC Phase 2 2024-07 China
BL-M07D1
HER2+ BC Phase 3
Sichuan Biokin
2024-03 China
HER2+ GC or GJA Phase 2 2024-05 China
ARX788
HER2+ BC Phase 2/3
Ambrx/NovoCodex
2020-06 China
HER2+ GC or GJA Phase 2/3 2021-06 China
FDA022-BB05
HER2-Expressing EC,
HER2-Low BC and
HER2-Overexpressing
Solid Tumors
Phase 2Shanghai Fudan-
Zhangjiang 2024-04 China
SHR-4602 HER2-Expressing or
HER2-Mutated Solid Tumors Phase 2Hengrui
Pharmaceuticals 2024-07 China
HER2-Mutated NSCLC Phase 2
BB-1701 Eisai/Bliss
Biopharmaceutical
2023-11 China
HER2-Low BC Phase 3
TQB2102 Chia Tai Tianqing
2024-08 China
HER2+ BC Phase 2 2024-01 China
DB-1303/BNT323 HER2+ BC Phase 3Our Group/BioNTech 2023-11 China
Epithelial Ovarian, Fallopian Tube,
or Primary Peritoneal Cancer Phase 3 2024-12 China
HER2+ BC Phase 3 2025-02 China
HER2+ GEA Phase 2 2024-10 China
Gynecological Tumor Phase 2 2025-02 China
GQ1005 HER2+ BC Phase 3GeneQuantum 2024-12 China
IBI354 Epithelial Ovarian, Fallopian Tube,
or Primary Peritoneal Cancer Phase 3Innovent 2025-02 China
HER2+ or HER2-low BC Phase 2 2024-01 U.S., Japan
HER2-Expressing or HER2-Mutated Solid Tumors Phase 2 2024-09 China
Note:
(1) First post date is the date on which the study record was first published on ClinicalTrials.gov or CDE’s
website, which may be different from the date on which a trial is initiated.
Sources: Clinicaltrials.gov, CDE, Frost & Sullivan
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The following table illustrates the key features of DB-1303 alongside Enhertu ®
(DS-8201), Kadcyla ® and Aidixi ®, the only three FDA and/or NMPA-approved HER2 ADCs as
of the Latest Practicable Date.
ADC design of HER2 ADCs (DB-1303, Enhertu ® (DS-8201), Kadcyla ® and Aidixi ®)
DB-1303
Enhertu ®
(DS-8201) Kadcyla ® Aidixi ®
Antibody /H1118/H1118/H1118/H1118/H1118Trastuzumab Trastuzumab Trastuzumab Disitamab
Linker /H1118/H1118/H1118/H1118/H1118/H1118/H1118Tetrapeptide-based
cleavable linker
GGFG linker MCC linker V al-Cit linker
Payload /H1118/H1118/H1118/H1118/H1118/H1118P1003, an exatecan
derivative and a
moderately
potent TOPO I
inhibitor
Dxd, an exatecan
derivative and a
moderately
potent TOPO I
inhibitor
DM1, a maytansine
derivative and a
highly potent
tubulin inhibitor
MMAE, a highly
potent tubulin
inhibitor
DAR /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188 8 3.5 4
Source: Literature review, Frost & Sullivan
GLOBAL B7-H3 ADC MARKET
Overview
B7-H3 is a prominent member of the B7 family that plays a critical role in promoting
tumor progression and metastasis. B7-H3 can effectively inhibit the function of T cells and NK
cells, and inhibit the production of cytokines, thus possibly promoting the immune escape of
cancer cells. High expression of B7-H3 is widely observed in various solid tumors, including
lung cancer, BC and prostate cancer. B7-H3 is an active area of research and a potential
therapeutic target for its role in tumor immune evasion, making it a potential backbone
treatment target for multiple cancer types. The table below sets forth the B7-H3 expression rate
in different cancer types.
Breast cancer
Gastric cancer
Small-cell lung cancer
Non-small cell lung cancer
Hepatocellular carcinoma
Castration-resistant prostate cancer
Cancer
57-74%
58%
65%
74%
92%
93%
B7-H3 Expression
Sources: Literature review, Frost & Sullivan
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As of the Latest Practicable Date, no B7-H3-targeting drug had been approved globally.
Clinical development has been conducted to develop therapies leveraging B7-H3’s role in
inhibiting tumor growth and enhancing anti-tumor immunity in various cancers. Despite the
current absence of approved B7-H3-targeted therapies, recent advancements in B7-H3 ADCs
have demonstrated encouraging clinical efficacy, sparking substantial interest and high-profile
licensing deals in the field. For example, in 2023, Merck & Co and GSK in-licensed B7-H3
ADC candidates from Daiichi Sankyo and Hansoh Pharma, respectively. In the same year, our
Group entered into an out-license and collaboration agreement to grant BioNTech the rights to
develop and commercialize DB-1311, also a B7-H3 ADC, outside Mainland China, Hong Kong
and Macau.
Market Opportunities of B7-H3 ADCs
Small-cell Lung Cancer
Lung cancer is the most common cancer and the leading cause of cancer death worldwide.
SCLC represents 10-15% of all lung cancer cases globally. The global incidence of SCLC
increased from 332.9 thousand cases in 2018 to 382.8 thousand cases in 2023, and is projected
to reach 484.1 thousand cases by 2032. In China, incidence of SCLC increased from 142.7
thousand cases in 2018 to 163.5 thousand cases in 2023, and is projected to reach 202.1
thousand cases by 2032. SCLC has two stages: limited stage, which is confined to one side of
the chest, and extensive stage, which spreads beyond the chest to other body parts. As a highly
aggressive cancer, the average five-year survival rate for SCLC patients in extensive stage is
less than 5%. B7-H3 is expressed in approximately 65% of SCLC cases. The global incidence
of B7-H3-overexpressing SCLC increased from 199.7 thousand cases in 2018 to 229.7
thousand cases in 2023, and is projected to reach 290.5 thousand cases by 2032. Our Group’s
DB-1311 is being investigated as a potential second-line (or later) treatment for SCLC patients,
with combination potential to expand into earlier treatment lines. Global incidence of SCLC
patients requiring first-line treatment increased from 243.6 thousand cases in 2018 to 284.9
thousand cases in 2023, and is projected to reach 368.2 thousand cases in 2032. Global
incidence of SCLC patients requiring second-line (or later) treatment increased from 127.1
thousand cases in 2018 to 149.4 thousand cases in 2023, and is projected to reach 194.8
thousand cases in 2032.
The global SCLC drug market grew from US$2.4 billion in 2018 to US$4.1 billion in
2023 at a CAGR of 11.9%, and is expected to increase to US$7.6 billion and US$10.6 billion
in 2028 and 2032, respectively, representing a CAGR of 13.0% from 2023 to 2028 and 8.7%
from 2028 to 2032. The chart below sets forth the growth of the global SCLC drug market.
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Global SCLC Drug Market Size, 2018-2032E
2.4 2.6 2.8 3.2
3.8 4.1
4.8
5.5
6.2
6.9
7.6
8.3
9.1
9.8
10.6
2018 2019 2020 2021 2022 2023 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E
Billions USD
Period CAGR
2018-2023 11.9%
2023-2028E 13.0%
2028E-2032E 8.7%
Sources: Frost & Sullivan
The current treatment landscape of SCLC primarily consists of platinum-based
chemotherapy, radiotherapy and immune checkpoint inhibitors such as PD-(L)1 inhibitors.
Novel treatment modalities, such as ADCs, are being investigated as a potential treatment for
SCLC patients.
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The charts below set forth the subsets of SCLC patients as well as the treatment paradigm
for SCLC in China and the U.S.
Treatment Paradigm for SCLC in China
First Line
Disease
Progression
Second Line
SCLC
Limited-Stage Extensive-Stage
CTFI ≤ 6 MONTHS CTFI > 6 MONTHS
Third line &
beyond
Level I recommendation
• Anlotinib
Level II recommendation
• Nivolumab
• Pembrolizumab
• Cisplatin + etoposide + concurrent
radiotherapy
• Carboplatin + etoposide + concurrent
radiotherapy
• Atezolizumab + Carboplatin + etoposide
• Durvalumab + Cisplatin + etoposide
• Durvalumab + Carboplatin + etoposide
• Serplulimab + Carboplatin + etoposide
• Adebrelimab + Carboplatin + etoposide
Disease
Progression
Level I recommendation
• Topotecan
Level III recommendation
• Bendamustine
• Lurbinectedin
Level I and II recommendation
• Original treatment plan
Level III recommendation
• Lurbinectedin
Level II recommendation
• Irinotecan
• Paclitaxel
• Docetaxel
• Gemcitabine
• Vinorelbine
• Temozolomide
• Trilaciclib/G-CSF
• Oral etoposide
Treatment Paradigm for SCLC in the U.S.
First Line
Disease
Progression CTFI ≤ 6 MONTHS CTFI > 6 MONTHS
Second
Line &
beyond
SCLC
Limited-Stage Extensive-Stage
• Cisplatin + etoposide + concurrent radiotherapy
• Carboplatin + etoposide + concurrent radiotherapy
• Carboplatin + etoposide + atezolizumab
• Carboplatin + etoposide + durvalumab
• Cisplatin + etoposide + durvalumab
• Carboplatin + irinotecan
• Cisplatin + irinotecan
• Clinical trial enrollment
• Lurbinectedin
• Topotecan
• Irinotecan
• Tarlatamab
• Re-treatment with
platinum-based doublet
• Nivolumab
• Pembrolizumab
• Paclitaxel
• Temozolomide
• Cyclophosphamide +
doxorubicin +
vincristine
• Docetaxel
• Gemcitabine
• Oral etoposide
• Clinical trial enrollment
• Re-treatment with platinum-based doublet
• Lurbinectedin
• Topotecan
• Tarlatamab
Note: Our Group’s DB-1311 is being investigated as a potential second-line (or later) treatment for SCLC patients,
with combination potential to expand into earlier treatment lines.
Source: CSCO 2024, NCCN 2024, Frost & Sullivan
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In China and the U.S., for limited stage SCLC patients, chemotherapy involving etoposide
plus cisplatin with concurrent radiotherapy is recommended as first-line treatment.
For extensive stage SCLC patients in China, first-line treatment options include (i)
chemotherapy of etoposide plus carboplatin, used in combination with atezolizumab or
serplulimab or durvalumab or adebrelimab, and (ii) chemotherapy of etoposide plus cisplatin,
used in combination with durvalumab. In second-line or later settings, topotecan, irinotecan
and clinical trials enrollment are recommended.
For extensive stage SCLC patients in the U.S., first-line treatment options include (i)
chemotherapy of etoposide plus carboplatin, used in combination with atezolizumab and
durvalumab (PD-(L)1 inhibitors), and (ii) chemotherapy of etoposide plus cisplatin, used in
combination with durvalumab (PD-(L)1 inhibitor). Subsequent lines of treatments include (i)
platinum-based doublet chemotherapy, (ii) topotecan-based and taxane-based chemotherapy
and other monotherapy such as lurbinectedin, and (iii) immunotherapies such as nivolumab and
pembrolizumab (PD-(L)1 inhibitors).
While chemotherapy is still the mainstay for SCLC treatment, SCLC patients often
develop resistance to chemotherapy and the disease often relapses within one year. Relapsed
SCLC patients often have worse prognosis, with limited treatment options available. While
immunotherapies such as PD-(L)1 inhibitors are also recommended in frontline settings for
extensive stage SCLC patients, there remains an unmet need for new and more effective
treatments for SCLC patients. B7-H3 overexpression is reported in 65% of all SCLC cases,
making it a promising target for novel treatments of SCLC.
Castration-resistant Prostate Cancer
CRPC is a severe form of prostate cancer that exhibits resistance to treatments aiming to
reduce testosterone levels. Initially, most prostate cancers depend on testosterone and other
hormones to grow. Standard treatment involves lowering testosterone to castrate levels by
surgical removal or chemical medications. However, CRPC patients have tumors that are
adapted to grow despite very low testosterone levels. These patients are typically treated with
androgen deprivation therapy (“ ADT”) to maintain low testosterone levels and androgen
receptor pathway inhibitors to block androgen activity, such as testosterone activity.
B7-H3 is expressed in approximately 93% of CRPC cases. The global incidence of
B7-H3-overexpressing CRPC increased from 158.8 thousand cases in 2018 to 183.5 thousand
cases in 2023, and is projected to reach 220.3 thousand cases by 2032. The global CRPC drug
market grew from US$2.4 billion in 2018 to US$3.9 billion in 2023 at a CAGR of 10.6%, and
is expected to increase to US$6.5 billion and US$9.0 billion in 2028 and 2032, respectively,
representing a CAGR of 10.9% from 2023 to 2028 and 8.4% from 2028 to 2032. The chart
below sets forth the growth of the global CRPC drug market.
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Global CRPC Drug Market Size, 2018-2032E
2.4 2.6 2.9 3.2 3.4
3.9
4.4
4.9
5.4
5.9
6.5
7.1
7.8
8.4
9.0
2018 2019 2020 2021 2022 2023 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E
Billions USD
Period CAGR
2018-2023 10.6%
2023-2028E 10.9%
2028E-2032E 8.4%
Sources: Frost & Sullivan
Among the subtypes of CRPC, metastatic CRPC (“ mCRPC ”) is particularly advanced
and challenging. The global incidence of mCRPC increased from 176.4 thousand cases in 2018
to 203.9 thousand cases in 2023 and is projected to reach 244.8 thousand cases by 2032. The
incidence of mCRPC in China increased from 42.8 thousand cases in 2018 to 50.5 thousand
cases in 2023, and is projected to reach 72.2 thousand cases by 2032. Our Group’s DB-1311
is being investigated as a potential second-line (or later) treatment for mCRPC patients, with
combination potential to expand into earlier treatment lines. Global incidence of mCRPC
patients requiring first-line treatment increased from 162.3 thousand cases in 2018 to 189.6
thousand cases in 2023, and is projected to reach 232.1 thousand cases in 2032. Global
incidence of mCRPC patients requiring second-line (or later) treatment increased from 108.7
thousand cases in 2018 to 127.5 thousand cases in 2023, and is projected to reach 157.1
thousand cases in 2032. The five-year survival rate for mCRPC patients is approximately 30%.
The current treatment landscape of mCRPC primarily consists of ADT, chemotherapy,
radiotherapy such as Radium-223, and PARP inhibitors. Novel treatment modalities, such as
ADCs, are being investigated as a potential treatment for mCRPC patients.
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The charts below set forth the treatment paradigm for mCRPC in China and the U.S.
Treatment Paradigm for mCRPC in China
mCRPC
Progression on prior docetaxel/
no prior novel hormone therapy
Progression on prior docetaxel and
a novel hormone therapy
Progression on prior novel hormone therapy/
no prior docetaxel
No prior docetaxel/
no prior novel hormone therapy
• Abiraterone/Prednisone
• Enzalutamide
• Docetaxel
• Radium-223 (for symptomatic bone metastases)
• Olaparib + Abiraterone for HRR mutation
• Niraparib + Abiraterone for BRCA mutation
• Talazoparib + Enzalutamide for HRR mutation
• Sipuleucel-T
• Docetaxel
• Olaparib
• Radium-223 (for symptomatic bone metastases)
• Enzalutamide/Abiraterone/Prednisone
• Cabazitaxel
• Sipuleucel-T
• Enzalutamide + Docetaxel
• Olaparib for HRR mutation
• Radium-223 for symptomatic bone metastases
• Docetaxel rechallenge
• Lu-177-PSMA-617 + SOC
• Pembrolizumab
• Radium-223 + Enzalutamide
• Etoposide
• Abiraterone/Prednisone
• Enzalutamide
• Olaparib for HRR mutation
• Radium-223 for symptomatic bone metastases
• Cabazitaxel
• Rezvilutamide
Treatment Paradigm for mCRPC in the U.S.
mCRPC
Progression on prior docetaxel/
no prior novel hormone therapy
Progression on prior docetaxel
and a novel hormone therapy
Progression on prior novel hormone therapy/
no prior docetaxel
No prior docetaxel/
no prior novel hormone therapy
• Abiraterone/Docet axel/Enzalutamide
• Niraparib/Olaparib + Abiraterone, for
BRCA mutation
• Pembrolizumab for MSI-H/dMMR
• Radium-223 for symptomatic bone metastases
• Sipuleucel-T
• Talazoparib + Enzalutamide for
HRR mutation
• Docetaxel
• Olaparib/Rucaparib for BRCA mutation
• Cabazitaxel + Carboplatin
• Niraparib + Abiraterone for BRCA mutation
• Olaparib for HRR mutation other than BRCA1/2
• Pembrolizumab for MSI-H/dMMR
• Radium-223 for symptomatic bone metastases
• Sipuleucel-T
• Talazoparib + Enzalutamide for HRR mutation
•    Abiraterone/Cabaz itaxel/Enzalutamide
•    Cabazitaxel + Carboplatin
•    Mitoxantrone for palliation in symptomatic
   patients who cannot tolerate other therapies
•    Niraparib/Olaparib  + Abiraterone for
   BRCA mutation
•    Pembrolizumab for MSI-H/dMMR
•    Radium-223 for symptomatic bone metastases
•    Sipuleucel-T
•    Talazoparib + Enzalutamide for HRR mutation
•    Cabazitaxel/Docetaxel rechallenge
•    Cabazitaxel + Carboplatin
•    Lutetium Lu 177 vipivotide tetraxetan (Lu-177-
   PSMA-617) for PSMA-positive metastases
•    Mitoxantrone for palliation in symptomatic
   patients who cannot tolerate other therapies
•    Olaparib for HRR mutation
•    Pembrolizumab for MSI-H, dMMR, or
   TMB ≥ 10 mut/Mb
•    Radium-223 for symptomatic bone metastases
•    Rucaparib for BRCA mutation
Note: Our Group’s DB-1311 is being investigated as a potential late-line treatment for CRPC patients, with
combination potential to expand into earlier treatment lines.
Source: CSCO 2024, NCCN 2024, Frost & Sullivan
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In China, for mCRPC patients without prior treatment of ADT and chemotherapy, level
I recommended treatment options include (i) abiraterone or prednisone, (ii) olaparib plus
abiraterone, (iii) enzalutamide, and (iv) docetaxel. For patients with ADT failure and without
prior treatment of chemotherapy, docetaxel or olaparib is recommended as level I treatment.
For patients with docetaxel treatment failure and without prior treatment of ADT, abiraterone,
prednisone, enzalutamide or olaparib is recommended as level I treatment. For patients with
docetaxel treatment failure and with prior treatment of chemotherapy, olaparib is recommended
as level I treatment. Radium-223 is also recommended for patients with symptomatic bone
metastases.
In the U.S., preferred regimens for mCRPC patients without prior docetaxel and novel
hormone therapy consist of abiraterone, docetaxel and enzalutamide. For patients with disease
progression after prior novel hormone therapy without prior docetaxel, preferred regimens
consist of (i) docetaxel and (ii) olaparib or rucaparib. For patients with disease progression
after prior docetaxel without prior novel hormone therapy, preferred regimens consist of
abiraterone, cabazitaxel and enzalutamide. For patients with disease progression after prior
docetaxel and novel hormone therapy, preferred regimens consist of cabazitaxel and docetaxel
rechallenge. Other regimens include radium-223, niraparib and pembrolizumab, recommended
based on metastases and mutation status.
The current treatment paradigm for mCRPC remains limited in its ability to provide
durable and effective long-term control. Drug resistance remains a critical challenge in the
treatment of mCRPC. While ADT like enzalutamide and abiraterone provides initial benefits,
most patients eventually develop resistance, leading to disease progression, underscoring the
potential of innovative targeted therapy to address this unmet need. With a B7-H3 expression
rate as high as 93% in all CRPC cases, B7-H3 ADCs are a promising treatment option for
CRPC.
Competitive Landscape
As of the Latest Practicable Date, there were no approved B7-H3 drugs, including ADCs,
globally. As of the same date, there were six B7-H3 ADCs under global MRCTs. The following
tables illustrate the global competitive landscape of B7-H3 ADCs under clinical development.
B7-H3 ADCs under Global MRCTs
Drug Name Indications Phase of TrialCompany First Post Date 2 Location
SCLC Phase 3
DS-7300 Daiichi Sankyo/
Merck Sharp & Dohme
2024-01 Global
DB-1311/BNT3243
Solid Tumors,  incl. SCLC, CRPC
and other cancer types Phase 1/2a
Our Group/BioNTech
2023-06
Advanced LC Phase 1/2 2025-03
YL201 Solid Tumors
Gastrointestinal Solid Tumors
Phase 1
Phase 1/2
MediLink 2022-09
2025-03
U.S., China
Global
Global
Global
Global
BGB-C354 Solid Tumors Phase 1BeiGene 2024-10 Global
MGC0181 mCRPC and Other Solid Tumors, incl. SCLC Phase 2MacroGenics 2022-09 Global
HS-20093/
GSK5764227 Solid Tumors Phase 1
Hansoh/GSK
2024-08
ESCC Phase 3 2025-02 Global
Notes:
(1) The trial of MGC018 on mCRPC patients was suspended according to MacroGenics’ announcement on July 30,
2024.
(2) First post date is the date on which the study record was first published on ClinicalTrials.gov or CDE’s
website, which may be different from the date on which a trial is initiated.
(3) In June 2024, DB-1311 was granted Fast Track Designation by the FDA for the treatment of patients with
advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic regimens, in
recognition of DB-1311’s potential for the treatment of this challenging tumor type. For details on the
requirements of Fast Track Designation, please refer to “Regulatory Overview — Overview of Laws and
Regulations in the United States — Laws and Regulations in Relation to New Drug — Expedited Development
and Review Programs.”
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Other B7-H3 ADCs under Clinical Development
Drug Name Indications Phase of TrialCompany First Post Date1 Location
DS-7300
Solid Tumors, incl. SCLC and CRPC
Daiichi Sankyo/
Merck Sharp
& Dohme
Solid Tumors, incl. EC and CRC Phase 2
Phase 1/2
2024-03
2019-10
U.S.
U.S., Japan
HS-20093/
GSK5764227
Limited-Stage SCLC Phase 3
Hansoh/GSK
2024-07 China
Osteosarcoma and Other Sarcomas Phase 2 2023-03 China
mCRPC Phase 2 2023-08 China
HNSCC Phase 2 2023-08 China
Extensive-Stage SCLC Phase 2 2023-09 China
Esophageal Carcinoma Phase 2 2023-11 China
Solid Tumors Phase 1 2022-03 China
mCRPC Phase 2YL201 MediLink 2024-01 China
Solid Tumors, incl. SCLC Phase 1/2 2023-08 China
MHB088C Solid Tumors, incl. SCLC and CRPC Phase 1/2Minghui
Pharmaceutical 2022-12 Australia
7MW3711 Solid Tumors Phase 1/2Mabwell 2023-08 China
IBI129 Solid Tumors, incl. SCLC Phase 1/2Innovent 2023-08 Australia
ILB-3101 Solid Tumors, incl. SCLC Phase 1/2Innolake
Biopharm 2024-05 China
MGC018 Solid Tumors, incl. CRPC Phase 1MacroGenics 2022-03 U.S.
BAT8009 Solid Tumors Phase 1Bio-Thera 2022-06 China
MGC026 Solid Tumors, incl. SCLC Phase 1MacroGenics 2024-02 U.S., Australia
BGB-C354 Solid Tumors Phase 1BeiGene 2024-05 U.S., Australia
Bone and Soft Tissue Sarcomas Phase 1 2024-12 China
SCLC Phase 3 2024-11 China
SYS6043 Solid Tumors, incl. SCLC Phase 1CSPC Group 2024-12 China
BB-1712 Solid Tumors Phase 1Bliss
Biopharmaceutical 2025-01 China
Note:
(1) First post date is the date on which the study record was first published on ClinicalTrials.gov or CDE’s
website, which may be different from the date on which a trial is initiated.
Sources: Clinicaltrials.gov, CDE, Frost & Sullivan
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The following table illustrates the key features of DB-1311, DS-7300 and MGC018, the
only three B7-H3 ADCs under global MRCTs in phase 1/2a clinical development or beyond.
ADC design of B7-H3 ADCs (DB-1311, DS-7300 and MGC018)
DB-1311 DS-7300 MGC018
Antibody /H1118/H1118/H1118/H1118Humanized anti-B7-H3
IgG1 mAb
Ifinatamab V obramitamab
Linker /H1118/H1118/H1118/H1118/H1118/H1118Tetrapeptide-based
cleavable linker
GGFG linker V aline-citrulline linker
Payload /H1118/H1118/H1118/H1118/H1118P1021, an exatecan
derivative and a
highly potent
TOPO I inhibitor
Dxd, an exatecan
derivative and a
moderately potent
TOPO I inhibitor
Seco-DUBA, a DNA
alkylating agent
DAR /H1118/H1118/H1118/H1118/H1118/H1118/H11186 4 2.7
Source: Literature review, Frost & Sullivan
GLOBAL HER3 ADC MARKET
Overview
HER3 is a cell surface receptor that is a member of the HER family, playing crucial roles
in tumor survival and growth. In contrast to other HER family members, HER3 is not
oncogenic when overexpressed alone. However, ubiquitous HER3 expression is detected in
various solid tumors, including breast, lung, colorectal, prostate, and head and neck cancers.
The table below sets forth HER3 expression rate in different cancer types.
Cancer HER3 Expression
Prostate cancer
Non-small cell lung cancer 83%
Cervical cancer 55-74%
Colorectal cancer 51-75%
Ovarian cancer 41-68%
Pancreatic cancer 41%
Gastric cancer 34-59%
Breast cancer 30-75%
90%
Sources: Literature review, Frost & Sullivan
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While it lacks intrinsic tyrosine kinase activity, HER3 is activated by dimerization with
another receptor, with EGFR and HER2 being its preferred dimerization partners, ultimately
promoting tumorigenesis, metastatic dissemination and drug resistance. Moreover, therapies
targeting HER3 can mediate resistance to other targeted therapies, including resistance of
NSCLC patients to EGFR targeted therapy and HER2+ BC patients to HER2-targeted therapy.
Despite the growing research and clinical interest in HER3, its exploration is still limited
and development of HER3-targeted drugs has been challenging due to the limited
understanding of its complex signaling pathway, its lack of intrinsic kinase activity and limited
internalization. As of the Latest Practicable Date, there were no approved HER3 ADCs
globally. HER3 ADCs represent a breakthrough approach that addresses the historical
challenges of targeting HER3. Unlike traditional inhibitors that depend on blocking HER3’s
signaling pathway, ADCs leverage HER3’s presence on tumor cells to deliver highly potent
cytotoxic payloads to directly kill tumor cells. Enhanced antibody engineering significantly
improves internalization efficiency, while HER3 ADCs’ bystander killing effect enables
elimination of neighboring cancer cells regardless of their HER3 expression levels. This
combination of targeted delivery, improved internalization, and bystander activity makes
HER3 ADCs a therapeutic opportunity that addresses diverse patient populations across
multiple tumor types without requiring specific biomarker selection. Initially targeting late-line
patients, the favorable efficacy and safety profiles of HER3 ADCs demonstrate their potential
to expand into earlier treatment lines where patients could benefit before their diseases
progress.
Market Opportunities of HER3 ADCs
Non-small Cell Lung Cancer
NSCLC is the most common subtype of lung cancer and represents approximately 85%
of all lung cancer cases globally. Global incidence of NSCLC increased from 1,886.3 thousand
cases in 2018 to 2,169.4 thousand cases in 2023 and is projected to reach 2,743.2 thousand
cases by 2032. In China, NSCLC incidence increased from 808.7 thousand cases in 2018 to
926.6 thousand cases in 2023, and is projected to reach 1,145.4 thousand cases by 2032. The
global NSCLC drug market grew from US$44.7 billion in 2018 to US$78.3 billion in 2023 at
a CAGR of 11.9%, and is expected to increase to US$143.1 billion and US$182.2 billion in
2028 and 2032, respectively, representing a CAGR of 12.8% from 2023 to 2028 and 6.2% from
2028 to 2032. The chart below sets forth the growth of the global NSCLC drug market.
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Global NSCLC Drug Market Size, 2018-2032E
44.7 50.2 52.8 60.5
72.9 78.3
91.5
104.0
116.9
130.4
143.1
154.6
165.1
174.2 182.2
2018 2019 2020 2021 2022 2023 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E
Billions USD
Period CAGR
2018-2023 11.9%
2023-2028E 12.8%
2028E-2032E 6.2%
Sources: Frost & Sullivan
A set of genetic abnormalities occurring in NSCLC have been identified as predictors for
patients’ responses to various targeted therapies, including EGFR mutations. Treatments
developed specifically for different subtypes of NSCLC based on these genetic differences can
be more effective for disease control.
EGFR-mutant NSCLC
EGFR-mutant (“ EGFRm ”) NSCLC is a prevalent subtype of NSCLC with approximately
700 thousand new cases each year globally. EGFR mutations are particularly prevalent in the
Asian population, accounting for over 50% of all NSCLC cases in this demographic group.
EGFR-TKIs are the major first-line therapies for EGFRm NSCLC, with chemotherapy
and PD-(L)1 inhibitors also used in the first-line setting or in specific clinical scenarios. Novel
treatment modalities, such as ADCs, are being investigated as a potential treatment for EGFRm
NSCLC patients.
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The charts below set forth the subsets of EGFRm NSCLC patients as well as the treatment
paradigm for EGFRm NSCLC in China and the U.S.
Treatment Paradigm for EGFRm NSCLC in China
EGFRm NSCLC
First Line
Disease
Progression
Second Line &
beyond
EGFR-Sensitive Mutant NSCLC
• Continue the original EGFR-TKI
treatment (for patients with minimal
or CNS progression)
• Osimertinib/Almonertinib/
Furmonertinib/Befotertinib
(for patients with T790M+ after first
or second generation EGFR-TKI failureͨ
• Platinum-based doublet chemotherapy
± bevacizumab (patients with T790M-
after third generation EGFR-TKI failure)
• Osimertinib
• Almonertinib
• Furmonertinib
• Befotertinib
• Afatinib
• Dacomitinib
• Gefitinib
• Erlotinib
• Icotinib
• TKIs + bevacizumab
• TKIs + chemotherapy
• Platinum-based
doublet
chemotherapy ±
bevacizumab
EGFR Exon
20 Insertion Mutation
• Suvotinib
•A m i v a n t a m a b
• Pembrolizumab
• Amivantamab combined
with platinum-based
doublet chemotherapy
Treatment Paradigm for EGFRm NSCLC in the U.S.
EGFRm NSCLC
First Line
Disease
Progression
Second Line &
beyond
•
•
•
•
•
•
•
•
•
•
EGFR S768I, L861Q,
and/or G719X Mutation
• Osimertinib
• Amivantamab +
carboplatin + pemetrexed
(nonsquamous)
• Afatinib
• Erlotinib
• Dacomitinib
• Gefitinib
• Osimertinib
EGFR Exon 19 Deletion or
Exon 21 L858R Mutation
• Osimertinib
• Amivantamab +
carboplatin + pemetrexed
(nonsquamousͨ
• Afatinib
• Erlotinib
• Dacomitinib
• Gefitinib
• Osimertinib
• Osimertinib + pemetrexed
+ (cisplatin or carboplatinͨ
(nonsquamous)
• Erlotinib + ramucirumab
• Erlotinib + bevacizumab
(nonsquamous)
EGFR Exon
20 Insertion Mutation
• Amivantamab
• Amivantamab +
carboplatin + pemetrexed
(nonsquamous)
Note: Our Group’s DB-1310 is being investigated as a potential treatment for TKI-resistant EGFRm NSCLC
patients in combination with osimertinib.
Source: CSCO 2024, NCCN 2024, Frost & Sullivan
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In China, the first-line treatments for EGFRm NSCLC patients include (i) TKIs, such as
osimertinib, almonertinib, furmonertinib, befotertinib, afatinib, dacomitinib, gefitinib,
erlotinib, and icotinib, (ii) combination therapy of TKIs and mAbs, (iii) platinum-based
doublet chemotherapy plus bevacizumab and (iv) combination therapy of TKIs and
chemotherapy. Second and subsequent lines of treatments include (i) continuous original
EGFR-TKI treatment in combination with local treatment, (ii) single-agent chemotherapy and
(iii) anlotinib.
In the U.S., the first-line treatments for EGFRm NSCLC patients include (i) TKIs, such
as afatinib, erlotinib, dacomitinib, gefitinib and osimertinib, (ii) combination therapy of TKIs
and mAbs, such as erlotinib with ramucirumab or bevacizumab. In second-line or later settings,
TKIs such as osimertinib and mobocertinib, and bispecific antibodies (“ bsAbs ”) such as
amivantamab are recommended.
TKIs are still the mainstay for EGFRm NSCLC treatment. However, most patients
eventually acquire resistance with median relapse occurring approximately 9-14 months after
treatment with TKIs. For patients who have failed TKIs, effective treatment options are
limited. HER3 has become a validated target for EGFRm NSCLC, supported by promising
efficacy data shown in pivotal trial. EGFR and HER3 can together form heterodimeric
complexes, leading to the activation of downstream signaling pathways. HER3 is also shown
to be an escape mechanism involved in resistance to EGFR TKI therapies.
Breast Cancer
The global incidence of BC increased from 2,088.8 thousand cases in 2018 to 2,408.0
thousand in 2023, and is projected to reach 3,195.7 thousand cases by 2032. While HER2 is
a well-established target for BC treatments, approximately 15-40% of all BC cases are
HER2-null, which show limited response to current HER2-targeted therapies. In addition,
HER2-expressing BCs commonly exhibit co-expression and activation of HER3. Inhibition of
HER2 can lead to a compensatory upregulation or activation of HER3, which can limit the
efficacy of HER2-targeted therapies, including HER2 ADCs. This feedback loop between the
two receptors highlights the importance of developing HER3-targeted therapies to overcome
potential resistance to HER2-targeted therapies. For more details on the background and
epidemiology of BC, see “— Global HER2 ADC Market — Market Opportunities of HER2
ADCs — Breast Cancer.”
Castration-resistant Prostate Cancer
HER3 is expressed in approximately 90% of prostate cancer cases and is commonly
overexpressed, making it an actionable target in treating prostate cancer, including CRPC. The
current treatment paradigm for CRPC remains limited in its ability to provide durable and
effective long-term control, underscoring the potential of innovative targeted therapy to
address this unmet need. For more details on the background and epidemiology of CRPC, see
“— Global B7-H3 ADC Market — Market Opportunities of B7-H3 ADCs — Castration-
resistant Prostate Cancer.”
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Competitive Landscape
As of the Latest Practicable Date, there were no approved HER3 ADCs, globally. As of
the same date, there were four HER3 ADCs under global MRCTs. The following tables
illustrate the global competitive landscape of HER3 ADCs under clinical development.
HER3 ADCs under Global MRCTs
Drug Name Indications Phase of Trial First Post Date 1 Location
U3-1402
EGFRm NSCLC NDA 2023-12 Global
Solid Tumors Phase 2 2023-12 Global
NSCLC Phase 1 2017-08 Global
DB-1310 Solid Tumors, incl.
NSCLC and BC Phase 1/2a 2023-03 Global
SHR-A2009 Solid tumors Phase 1 2021-11 Global
Company
Daiichi Sankyo/Merck
Sharp & Dohme
Our Group
Hengrui Pharmaceuticals
YL202/BNT326 NSCLC and BC Phase 1 2022-12 China, U.S.MediLink/BioNTech
Gastrointestinal Cancers Phase 1/2 2024-09 Global
Other HER3 ADCs under Clinical Development
Drug Name Indications Phase of Trial First Post Date 1 Location
U3-1402
BC Phase 2 2021-01 U.S.
BC and NSCLC with Brain Metastases Phase 2 2023-05 Austria, Spain
HER3+ BC Phase 1/2 2016-12 U.S., Japan
YL202/BNT326
Solid Tumors Phase 2 2023-10 China
mTNBC Phase 2 2024-06 China
Company
Daiichi Sankyo/
Merck Sharp & Dohme
MediLink/BioNTech
IBI133 Solid Tumors Phase 1/2 2023-12 Australia
AMT-562 Solid Tumors Phase 1 2024-01 Australia
SIBP-A13 Solid Tumors Phase 1 2024-02 China
Innovent
Multitude Therapeutics
Shanghai Institute Of
Biological Products
SHR-A2009 Solid Tumors Phase 1b/2 2023-10 China
BC Phase 1/2 2024-01 China
Hengrui Pharmaceuticals
EGFRm NSCLC Phase 3 2024-11 China
AK138D1 Solid Tumors Phase 1 2024-12 AustraliaAkeso
Note:
(1) First post date is the date on which the study record was first published on ClinicalTrials.gov or CDE’s
website, which may be different from the date on which a trial is initiated.
Sources: Clinicaltrials.gov, CDE, Frost & Sullivan
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The following table illustrates the key features of DB-1310 and U3-1402, the only two
HER3 ADCs under global MRCTs in phase 1/2a clinical development or beyond.
ADC design of HER3 ADCs (DB-1310 and U3-1402)
DB-1310 U3-1402
Antibody /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Humanized anti-HER3 IgG1 mAb Patritumab
Linker /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Tetrapeptide-based cleavable
linker
GGFG linker
Payload /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118P1021, an exatecan derivative
and a highly potent TOPO I
inhibitor
Dxd, an exatecan derivative and
a moderately potent TOPO I
inhibitor
DAR /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188 7-8
Source: Literature review, Frost & Sullivan
GLOBAL TROP2 ADC MARKET
Overview
TROP2 is a transmembrane protein that has essential functions in embryonic and organ
development with low expression in normal tissues. TROP2 is a clinically valuable ADC target
as it is overexpressed in a wide range of highly prevalent or hard-to-treat cancers, including
advanced tumors with limited actionable targets. The table below sets forth the TROP2
expression rate in different cancer types.
Endometrial cancer
Cancer
Ovarian cancer
Urothelial cancer
Cervical cancer
Castration-resistant prostate cancer
Pancreatic cancer
Breast cancer
Gastric cancer
Non-small cell lung cancer
96%
TROP2 Expression
91%
90%
89-98%
89%
87%
80%
66%
64-75%
Sources: Literature review, Frost & Sullivan
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TROP2 ADCs have demonstrated synergistic anti-tumor activity in various preclinical
and clinical studies as the backbone of potential combination therapies with other treatment
modalities such as chemotherapy, targeted therapy and immunotherapy. Despite the
encouraging therapeutic benefits shown by TROP2 ADCs, the global clinical development of
TROP2 ADCs is currently heavily focused on triple-negative breast cancer (“ TNBC ”),
HR+/HER2- BC, UC and NSCLC. This leaves unmet needs among patients with other
prevalent or hard-to-treat cancers, such as OC.
Addressable Market Size
The first TROP2 ADC was approved by the FDA in 2020 and by the NMPA in 2022.
Driven by TROP2 ADCs’ proven success in indication expansion and the continued exploration
of new clinical applications, the global TROP2 ADC market reached US$1.1 billion in 2023.
It is expected to increase to US$7.7 billion in 2028, with a CAGR of 48.8% from 2023 and
further increase to US$23.4 billion in 2032 at a CAGR of 31.8% from 2028. In China, the
market size for TROP2 ADCs is projected to reach US$3.4 billion in 2032, representing a
CAGR of 63.8% from 2028. The chart below sets forth the growth of the global TROP2 ADC
market with a breakdown by major regions.
Global TROP2 ADC Market Size, 2018-2032E
China U.S. ROW
4.2
2.11.4 3.0
5.5
7.0
8.9
11.2
1.3
0.1 0.3 0.5 0.8
2.1
3.1
4.4
5.7
7.1
8.8
5.4
3.5
7.7
10.7
14.0
18.2
23.4
2018 2019 2020 2021 2022 2023 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E
2.2 3.4
Period
CAGR
China U.S. ROW Global
2018-2023 NA NA NA NA
2023-2028E 117.7% 39.8% 62.4% 48.8%
2028E-2032E
Billion USD
63.8% 28.2% 29.5% 31.8%
1.4
0.7 1.1 1.5 2.2
0.40.0 0.1
0.8
0.0
1.0
0.4
0.00.0
0.8
0.3
0.5
0.2
Source: Frost & Sullivan
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Market Opportunities of TROP2 ADCs
Ovarian Cancer
OC is the third most common cancer of the female reproductive system worldwide. High
expression of TROP2 is reported in about 83% of OC patients. The global incidence of OC
increased from 295.4 thousand cases in 2018 to 333.9 thousand cases in 2023, and is projected
to further increase to 396.8 thousand cases by 2032. In China, incidence of OC increased from
57.8 thousand cases in 2018 to 61.6 thousand cases in 2023, and is projected to increase to 66.6
thousand cases by 2032. TROP2 is expressed in approximately 91% of OC cases. The global
incidence of TROP2-overexpressing OC increased from 173.1 thousand cases in 2018 to 195.7
thousand cases in 2023, and is projected to reach 232.5 thousand cases by 2032. The global OC
drug market grew from US$3.1 billion in 2018 to US$4.8 billion in 2023 at a CAGR of 9.2%,
and is expected to increase to US$8.1 billion and US$11.2 billion in 2028 and 2032,
respectively, representing a CAGR of 11.1% from 2023 to 2028 and 8.5% from 2028 to 2032.
The chart below sets forth the growth of the global OC drug market.
Global Ovarian Cancer Drug Market Size, 2018-2032E
7.4
3.7 4.0
3.1 3.3
4.4 4.8
5.4
6.0
6.7
8.1
8.8
9.6
10.4
11.2
2018 2019 2020 2021 2022 2023 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E
Billion USD
Period
2018-2023
2023-2028E
2028E-2032E
CAGR
9.2%
11.1%
8.5%
Sources: Frost & Sullivan
The current treatment landscape of OC primarily consists of platinum-based
chemotherapy, targeted therapies such as PARP inhibitors and anti-VEGF mAbs, and
immunotherapy such as ICIs. Novel treatment modalities, such as ADCs, are being investigated
as a potential treatment for OC patients.
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The charts below set forth the subsets of OC patients as well as the treatment paradigm
for OC in China and the U.S.
Treatment Paradigm for OC in China
Primary Chemotherapy/
Primary Adjuvant Therapy
 Paclitaxel + carboplatin
 Carboplatin + doxorubicin liposomes
 Carboplatin + docetaxel
STAGE I
OC
 Paclitaxel + carboplatin
 Carboplatin + docetaxel
 Paclitaxel + carboplatin + bevacizumab
STAGE II-IV
PLATINUM-SENSITIVE
RECURRENCE THERAPY
PLATINUM-RESISTANT
 Secondary surgical cytoreduction + platinum-
based combination chemotherapy ±
maintenance therapy
 Platinum-based combination chemotherapy
± maintenance therapy
 Hormone therapy
 PARP inhibitors (for tumors with BRCA1/2
mutations)
 Niraparib + bevacizumab
 Non-platinum-based chemotherapy
 Immune checkpoint inhibitors
 Doxorubicin liposome ± bevacizumab
 Paclitaxel (weekly) ± bevacizumab
 Topotecan ± bevacizumab
 Docetaxel
 Oral etoposide
 Gemcitabine ± bevacizumab
 Doxorubicin liposome + apatinib
Treatment Paradigm for OC in the U.S.
Primary Chemotherapy/
Primary Adjuvant Therapy
OC
 Paclitaxel + carboplatin
 5-FU + Leucovorin + Oxaliplatin ± Bevacizumab
 Capecitabine + oxaliplatin ± bevacizumab
 Paclitaxel + carboplatin ± maintenance letrozole or
other hormonal therapy
 Hormone therapy (aromatase inhibitors: anastrozole
letrozole
exemestane)
STAGE II-IV
PLATINUM-SENSITIVE
RECURRENCE THERAPY
PLATINUM-RESISTANT
 Carboplatin + gemcitabine ± bevacizumab
 Carboplatin + liposomal doxorubicin
± bevacizumab
 Carboplatin + paclitaxel ± bevacizumab
 Cisplatin + gemcitabine
 Bevacizumab
 Cyclophosphamide (Oral) + bevacizumab
 Docetaxel
 Oral etoposide
 Gemcitabine
 Liposomal doxorubicin
 Paclitaxel (weekly)
 Topotecan
 Bevacizumab
 Mirvetuximab soravtansine (for FR α-expressing tumors)
STAGE I
 Paclitaxel + carboplatin
 5-FU + leucovorin + oxaliplatin
 Capecitabine + oxaliplatin
Paclitaxel + carboplatin ± maintenance letrozole or
other hormonal therapy

Hormone therapy (aromatase inhibitors: anastrozole
letrozole
exemestane)

Carboplatin + liposomal doxorubicin
Note: Our Group’s DB-1305 is being investigated as (i) a potential second-line (or later) treatment for OC patients,
and (ii) a potential early-line treatment for OC patients in combination with a PD-L1x VEGF bsAb.
Source: CSCO 2024, NCCN 2024, Frost & Sullivan
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In China, first-line treatments for OC include (i) carboplatin and paclitaxel or docetaxel
or doxorubicin liposome, (ii) paclitaxel and carboplatin with bevacizumab. For relapsed
patients resistant to platinum-based chemotherapy, recommended treatments include (i)
doxorubicin liposome with or without bevacizumab, (ii) docetaxel or etoposide or gemcitabine,
(iii) topotecan hydrochloride with or without bevacizumab, (iv) doxorubicin liposome plus
apatinib, and (v) PARP inhibitors.
In the U.S., preferred regimens for primary therapy of OC include (i) carboplatin and
paclitaxel, (ii) 5-FU, leucovorin and oxaliplatin, (iii) capecitabine and oxaliplatin, and (iv)
hormone therapy such as anastrozole, letrozole and exemestane. For platinum-sensitive
patients, recurrence therapy includes (i) carboplatin and gemcitabine with or without
bevacizumab, (ii) carboplatin and doxorubicin liposome with or without bevacizumab, (iii)
carboplatin and paclitaxel with or without bevacizumab, and (iv) cisplatin and gemcitabine.
For platinum-resistant patients, preferred regimens include (i) cyclophosphamide or
bevacizumab, (ii) docetaxel, (iii) etoposide, (iv) gemcitabine, and (v) liposomal doxorubicin or
paclitaxel or topotecan with or without bevacizumab.
Chemotherapy represents the mainstay of standard treatments for advanced OC in China
and the U.S., which involves platinum-based and taxane-based chemotherapy with or without
antiangiogenic mAb bevacizumab. However, the disease often recurs in a more resistant form
even after initial successful treatment with surgery and chemotherapy. Immunotherapy, such as
PD-(L)1 inhibitors, may be considered for patients with certain immunotherapy biomarkers
who have no satisfactory alternative treatment options. However, immunotherapy, while
promising, has shown limited effectiveness in OC when used as a monotherapy. This limited
efficacy and high recurrence rate underscore the need for more effective and durable treatment
options that can improve long-term survival outcomes for patients.
Traditionally, ADC development has focused on FR /H9251-positive OC patients, who
constitute a limited subset of the OC population. Given that TROP2 is overexpressed in the
majority of OC patients and the under-exploration of OC as an indication for other TROP2
ADC candidates, TROP2 ADCs targeting OC patients represent a promising therapeutic
strategy with vast potential. In addition, TROP2 ADCs can potentially provide a novel
therapeutic option when standard platinum-based chemotherapy is no longer effective. They
can also be used in combination with or as a complement to standard platinum-based
chemotherapy, potentially enhancing treatment efficacy.
Non-small Cell Lung Cancer
TROP2 is broadly overexpressed in NSCLC, making TROP2 ADCs a promising modality
for treating advanced NSCLC regardless of driver mutation status. Lung cancer is the most
common cancer and the leading cause of cancer death worldwide, with NSCLC accounting for
over 85% of all lung cancer cases. For more details on the background and epidemiology of
NSCLC, see “— Global HER3 ADC Market — Market Opportunities of HER3 ADCs —
Non-small Cell Lung Cancer.” TROP2 is expressed in approximately 64-75% of NSCLC cases.
The global incidence of TROP2-overexpressing NSCLC increased from 997.9 thousand cases
in 2018 to 1,147.6 thousand cases in 2023, and is projected to reach 1,451.2 thousand cases by
2032.
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Competitive Landscape
As of the Latest Practicable Date, Trodelvy ® was the only TROP2-targeted drug approved
both in the U.S. and in China, indicated for mTNBC, metastatic UC (“ mUC”) and HR+/HER2-
BC in the U.S., and for mTNBC in China. Despite its promising clinical activity, Trodelvy ® is
associated with severe neutropenia (i.e., a lower-than-normal number of neutrophils in the
blood) and severe diarrhea, two serious adverse reactions for which Trodelvy
® has black box
warnings issued by the FDA. Consequently, there is a need for novel TROP2 ADCs that have
limited toxicities while maintaining robust anti-tumor activity. As of the same date, there were
one additional TROP2-targeted drug approved in China, SKB264 (brand name: Գइഺ
®),
indicated for mTNBC, and one approved in the U.S., Datroway ®, indicated for HR+/HER2-
BC.
The following tables illustrate the global competitive landscape of marketed TROP2
ADCs, TROP2 ADCs indicated for OC under clinical development, and TROP2 ADCs in
combination with immunotherapies in phase 1/2 clinical development or beyond.
Marketed TROP2 ADCs Globally
Brand Name
(Chemical Name;
Code Name)
Company Indications Treatment
Line
FDA
First
Approval
NMPA
First
Approval
Global
Sales in 2023Price NRDL
Inclusion
U.S.
Insurance/
Assistance
Program
Coverage
Patent
Expiry Date
Trodelvy®
(Sacituzumab
govitecan;
IMMU-132)
Gilead
≥3L
2021.04
2020.04
2023.02
2022.06
US$1,063.0
million
US$2,604/
180mg No 100% 2028 (U.S.)
2029 (EU)≥3L
2025.03
N/A
mTNBC
≥2L
mUC
Ղହṿ®
(Sacituzumab
Tirumotecan;
SKB264)
Kelun-Biotech/
Merck Sharp
& Dohme
N/ARMB9,399/
200mg No N/A 2038 (China)
Daiichi Sankyo/
AstraZeneca
Datroway®
(datopotamab
deruxtecan-dlnk)
N/A N/A US$4,891/
100mg N/A 100% 2034 (U.S.)
2034 (EU) ≥2L 2025.01HR+/HER2- BC
HR+/HER2- BC
2024.11N/AmTNBC ≥3L
≥3L N/A 2025.03EGFRm NSCLC
Sources: Clinicaltrials.gov, CDE, Frost & Sullivan
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TROP2 ADCs Indicated for OC under Clinical Development
Drug Name Indications Phase of TrialCompany First Post Date1 Location
DS-1062 Solid Tumors,  incl. OC Phase 2Daiichi Sankyo
/AstraZeneca 2022-08 Global
DB-1305/
BNT3252 Solid Tumors, incl. OC Phase 1/2aOur Group/BioNTech 2022-06 Global
SHR-A1921 OC Phase 3Hengrui Pharmaceuticals 2024-05 China
XYD-9668-198 Solid Tumors,  incl. OC Phase 1/2Xinyunda Biotechnology 2023-04 China
BHV1510/
GQ1010 Solid Tumors,  incl. OC Phase 1/2GeneQuantum/Pyramid
Biosciences 2024-05 China
FDA018 Solid Tumors,  incl. OC Phase 1Fudan-Zhangjiang
Bio-Pharmaceutical 2022-01 China
DXC1002 Solid Tumors,  incl. OC Phase 1DAC Biotech 2023-12 China
SKB264/
MK-2870
Solid Tumors,  incl. OC Phase 2
Kelun-Biotech/Merck
Sharp & Dohme
2022-12 Global
Platinum-sensitive OC Phase 3 2025-02 Global
TROP2 ADCs in Combination with Immunotherapies
under Clinical Development (Phase 1/2 or beyond)
Drug Name Indications Combo IO Drug Phase of Trial First Post Date 1 Location
DS-1062
NSCLC PD-1 mAb Phase 3 2022-01 Global
TNBC PD-1 mAb Phase 3 2022-11 Global
TNBC or HR-Low/
HER2- BC PD-L1 mAb+chemo Phase 3 2023-11 Global
Sacituzumab
Govitecan
TNBC PD-1 mAb Phase 3 2022-05 Global
NSCLC PD-1 mAb+chemo Phase 2 2022-01 Global
HR+/HER2- BC PD-1 mAb Phase 3 2024-03 Global
TNBC PD-1 mAb Phase 3 2024-05 Global
Company
Daiichi Sankyo
/AstraZeneca
Gilead
SKB264/MK-2870 NSCLC PD-L1 mAb+chemo Phase 2 2022-04 China
HER2- BC PD-L1 mAb Phase 2 2022-07 China
Solid Tumors PD-1 mAb Phase 2 2022-12 Global
2024-07 GlobalUC PD-1 mAb+chemo Phase 1/2
DB-1305/BNT3252
OC
PD-L1×
VEGF bsAb
Phase 1/2a 2022-06 Global
NSCLC Phase 1/2a 2022-06 Global
TNBC Phase 1/2a 2022-06 Global
CC Phase 1/2a 2022-06 Global
SHR-1921 NSCLC CTLA-4 mAb+PD-L1 mAb Phase 1/2 2024-05 China
BIO-106 Solid Tumors PD-1 mAb Phase 1/2 2022-04 U.S.
LCB84 Solid Tumors PD-1 mAb Phase 1/2 2023-07 U.S., Canada
BAT8008 Solid Tumors PD-1 mAb Phase 1/2 2024-04 China
Kelun-Biotech/
Merck Sharp &
Dohme
Our Group/
BioNTech
Hengrui
Pharmaceuticals
BiOneCure
Therapeutics
LegoChem
Biosciences
Bio-Thera
Non sq-NSCLC PD-1 mAb Phase 3 2024-09 China
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Note:
(1) First post date is the date on which the study record was first published on ClinicalTrials.gov or CDE’s
website, which may be different from the date on which a trial is initiated.
(2) In January 2024, DB-1305 was granted Fast Track Designation by the FDA for patients with platinum-resistant
epithelial ovarian, fallopian tube, or primary peritoneal cancer, acknowledging its potential to address unmet
medical needs. For details on the requirements of Fast Track Designation, please refer to “Regulatory
Overview — Overview of Laws and Regulations in the United States — Laws and Regulations in Relation to
New Drug — Expedited Development and Review Programs.”
Sources: Clinicaltrials.gov, CDE, Frost & Sullivan
The following table illustrates the key features of DB-1305 alongside Trodelvy ®, the only
TROP2 ADC approved both by the FDA and the NMPA as of the Latest Practicable Date, as
well as DS-1062 and SKB264/MK-2870, the only two TROP2 ADCs indicated for OC under
global MRCTs in phase 1/2a clinical development or beyond other than DB-1305.
ADC design of TROP2 ADCs (DB-1305, Trodelvy
®, DS-1062 and SKB264/MK-2870)
DB-1305 Trodelvy® DS-1062 SKB264/MK-2870
Antibody /H1118/H1118/H1118/H1118/H1118Sacituzumab Sacituzumab Datopotamab Sacituzumab
Linker /H1118/H1118/H1118/H1118/H1118/H1118/H1118Tetrapeptide-based
cleavable linker
Maleimide-
containing
CL2A linker
GGFG linker 2-methylsulfonyl
pyrimidine
containing
CL2A linker
Payload /H1118/H1118/H1118/H1118/H1118/H1118P1021, an exatecan
derivative and a
highly potent
TOPO I
inhibitor
SN38, a metabolite
of the
camptothecin
derivative and a
moderately
potent TOPO I
inhibitor
Dxd, an exatecan
derivative and a
moderately
potent TOPO I
inhibitor
T030, a belotecan-
derivative TOP I
inhibitor
DAR /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184 7.6 4 7.4
Source: Literature review, Frost & Sullivan
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OVERVIEW OF BISPECIFIC ADCS
Bispecific ADCs (“ BsADCs ”) are next-generation therapeutics that combine the targeting
precision of bsAbs with the potent cytotoxicity of ADCs. By incorporating two distinct binding
moieties in a single therapeutic entity, BsADCs can potentially offer meaningful advantages
over traditional monospecific ADCs and their combination therapies. While promising, the
complexity of BsADCs introduces new challenges in antibody engineering, stability and
manufacturing, setting a high entry barrier.
BsADCs employ various design strategies to enhance therapeutic efficacy and safety,
represented by the tumor-associated antigen (“ TAA”) + immunotherapy (“ IO”) approach and
the dual-TAA approach. The TAA + IO strategy utilizes dual-function antibodies that
simultaneously target TAAs on cancer cells to induce direct tumor cell death while engaging
IO targets to activate the immune system, promoting more potent and durable anti-tumor
responses.
By comparison, the dual-TAA approach targets two distinct, carefully selected TAAs
co-expressed on cancer cells, enhancing binding specificity, reducing off-tumor toxicity, and
potentially overcoming tumor heterogeneity and antigen escape mechanisms.
The mechanisms of actions of the TAA+IO approach and the dual-TAA approach are
illustrated below.
TAA+IO Approach Dual-TAA Approach
Source: Development of bispecific antibodies in China: overview and prospects, Frost & Sullivan
Both strategies aim to improve the therapeutic index of ADCs by increasing tumor-
specific targeting while minimizing off-target effects, with the choice between approaches
depending on the specific cancer type, target availability, and desired mechanism of action. In
recent years, BsADC has attracted growing interest and development as a new modality, with
over ten BsADCs under current clinical development across a broad range of solid tumors and
hematological malignancies.
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TAA+IO Approach: B7-H3xPD-L1 BsADCs
BsADCs that can simultaneously block both PD-L1 and B7-H3 pathways are developed
under the TAA+IO approach to synergistically enhance T cell activity and cancer cell killing.
B7-H3’s pan-cancer expression coupled with PD-L1’s immune-modulating function may offer
enhanced anti-tumor effects across broad indications. Studies have shown that B7-H3xPD-L1
BsADCs may have strong binding and neutralizing capabilities and can potentially achieve
better anti-tumor activity than using PD-L1 or B7-H3 antibodies alone or in combination.
B7-H3xPD-L1 BsADCs have treatment potential across various solid tumors, including SCLC,
hepatocellular carcinoma (“ HCC”), NSCLC, melanoma, ESCC and TNBC.
Dual-TAA Approach: EGFRxHER3 BsADCs
BsADCs that target EGFR and HER3 are a representative therapy of the dual-TAA
BsADC approach. EGFR is a cell surface receptor with key roles in multiple signaling
pathways that promote cell proliferation and survival. Aberrant activation of EGFR, such as
overexpression or mutation, is widely established as an oncogenic driver in a wide range of
cancers, such as CRC, HNSCC and NSCLC. HER3 belongs to the same family as EGFR and
preferentially forms heterodimers with EGFR to activate downstream oncogenic pathways.
Due to target synergies, EGFRxHER3 BsADCs have demonstrated enhanced efficacy and
ability to overcome resistance to EGFR-directed treatments in clinical studies. Potential
indications for EGFRxHER3 BsADCs include ESCC, HNSCC, CRC, nonmelanoma skin
cancer, NSCLC, gastric cancer (“ GC”), pancreatic adenocarcinoma, nasopharyngeal cancer,
bladder cancer and BC.
THE AUTOIMMUNE DISEASE TREATMENT MARKET
Overview
Autoimmune diseases are caused by the abnormal functioning of the immune system,
where the body’s immune system mistakenly attacks its normal cells and tissues. Many
autoimmune diseases are chronic conditions that require lifelong treatment. Major types of
autoimmune disease include systemic lupus erythematosus (“ SLE”), cutaneous lupus
erythematosus (“ CLE”), rheumatoid arthritis and psoriasis.
ADC as An Emerging Modality for Autoimmune Disease Treatment
For decades, a considerable number of autoimmune disease patients have suffered from
drug-related side effects and emerging challenges from novel therapies such as paradoxical
effects of biologics and immune-related adverse events (“ AEs”). Anti-inflammatory agents,
such as non-steroidal anti-inflammatory drugs (“ NSAIDs ”), glucocorticoids and disease-
modifying anti-rheumatic drugs, are commonly used treatment options for patients with
autoimmune diseases, particularly during the initial stages of disease. While they are effective
in alleviating pain, reducing fever and mitigating inflammatory responses, they are limited to
easing symptoms instead of treating the cause of disease. Moreover, many of these
anti-inflammatory agents are systemic treatments, and as a result, may globally impair the
immune system with long-term use and result in serious side effects, such as increased
susceptibility to infections, metabolic disturbances and cardiovascular complications.
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In recent years, targeted treatments such as biologics have been developed and marketed
with better safety profiles. However, current drawbacks of biologic therapies prevent their
wider use as first-line treatments for autoimmune diseases, which include paradoxical effects,
side effects on normal immune functions and responses, narrow therapeutic window due to
drug resistance, and poor patient compliance resulting from the inconvenience of intravenous
administration. While cell therapies such as CAR-T cell therapy have emerged as a promising
approach for treating certain autoimmune diseases, the B-cell depletion associated with this
therapy can subsequently jeopardize the overall integrity of patients’ immune systems,
presenting a significant clinical challenge. The table below sets forth the current treatment
landscape for autoimmune diseases.
Type Subtype Mechanism of Action
Anti-inflammatory
Agents
NSAIDs
SAIDs
(Glucocorticoids)
Targeted
Biologics
Anti-TNF
Antibodies
Interleukin Related
Drugs
Other Monoclonal
Antibodies
Other Novel
Therapy CAR-T
Representative
Drugs
Aspirin
Ibuprofen
Dexamethasone
Prednisone
Infliximab
Rilonacept
Rituximab
Under
development
Dates of Market
Launch
1899
1969
1958
1955
1998
2008
1997
N.A.
Drawbacks
• May affect the normal immune function
 and its response, leading to the development of
 many autoimmune phenomena and diseases
• May affect the normal immune function and
 its response, leading to the development of
 many autoimmune phenomena and diseases
• Long-term use of targeted biologics can easily
 lead to the drug resistance, thereby reducing
 the therapeutic effect
• Inconvenience of intravenous administration,
 leading to poor patient compliance
• Long-term GC use should be individualized
 based on patient characteristics and minimized
 due to their potential AEs
• Side effects are potentially severe or even
 life-threatening immune-related toxicities,
 specifically cytokine release syndrome (CRS)
 and immune effector cell-associated
 neurotoxicity syndrome (ICANS)
• Long manufacturing time and high treatment costs
• Traditional non-selective NSAIDs inhibit
 platelet aggregation and cause significant
 gastrointestinal disorders such as bleeding,
 ulcers, and perforation
Exert an anti-inflammatory effect
by inhibiting the activity of
cyclooxygenase (COX)
Prevent the formation of both
PGs and LTs by causing the
release of lipocortin, which by
inhibition of phospholipase A2
reduces arachidonic acid release
Bind to TNF-α to prevent its
association with receptors on the
cell surface, thereby blocking the
signaling pathways mediated by
TNF-α
Target specific antigens on cells
(e.g., CD20, CD22), leading to
cell lysis or inhibition of cell
proliferation
Target and inhibit interleukins
involved in inflammation
Modify the patients’ T-cells to
recognize and attack abnormal
B-cells
Adalimumab
Etanercept
2002
1998
Anakinra
Secukinumab
2001
2015
Ocrelizumab 2017
* CAR-T cell therapy has not been approved for autoimmune diseases.
ADCs represent a promising new frontier and an area of growing interest for autoimmune
and inflammatory conditions given their high specificity for target cells, enabling potent
payloads (anti-inflammatory agents) to be delivered with minimal impact to healthy cells. As
a result, ADCs may enable durable treatment response and improved patient outcomes
compared to existing therapies.
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While no autoimmune ADCs have been approved, the advantages and potential of ADCs
indicated for autoimmune diseases have attracted significant research interest and investment.
With the continuous advancements in this field, next-generation ADCs are expected to
maximize therapeutic efficacy while reducing the risk of off-target toxicities that have
hampered some earlier autoimmune ADC candidates.
Global Autoimmune Diseases Drug Market Size
The global autoimmune disease drug market size increased from US$113.7 billion in 2018
to US$133.8 billion in 2023 at a CAGR of 3.3%. Targeted biologics have become the mainstay
treatment of autoimmune diseases. The global autoimmune disease drug market is expected to
continue its growth at a CAGR of 4.1% and 4.1% from 2023 to 2028 and from 2028 to 2032,
respectively, and reach US$192.3 billion in 2032.
Global Autoimmune Disease Drug Market, 2018-2032E
73.0 74.9 76.9 80.1 83.1 83.6 86.0 89.4 92.7 96.1 99.5 102.8 106.0 109.4 112.7
38.7 39.6 41.2 44.8 46.1 46.1 47.8 49.0 50.0 50.8 51.3 51.6 51.9 52.2 53.2
113.7 116.9 120.6 127.7 132.3 133.8 138.9 144.8 150.9 157.2 163.5 170.0 176.7 183.9 192.3
2018 2019 2020 2021 2022 2023 2024E 2025E 2026E 2027E 2028E 2029E 2030E 2031E 2032E
2.0 2.5 2.5 2.8 3.1 4.0 5.0 6.5 8.2
10.3 12.7 15.5 18.8 22.4 26.3
China U.S. ROW
Period CAGR
China U.S. ROW Global
2018-2023 13.4% 2.8% 3.7% 3.3%
2023-2028E 27.3% 3.5% 2.1% 4.1%
2028E-2032E
Billion USD
20.0% 3.2% 0.9% 4.1%
Source: Frost & Sullivan
GLOBAL BDCA2 ADC MARKET
Overview
Blood dendritic cell antigen 2 (“ BDCA2 ”) is a transmembrane protein uniquely expressed
on the surface of plasmacytoid dendritic cells (“ pDCs ”). pDCs play a crucial role in the innate
immune response and BDCA2 acts as an inhibitory receptor on pDCs, modulating their
activation and function. Targeting BDCA2 can inhibit pDC activation and the subsequent
production of type I interferons, which are known to play a key pathogenic role in various
autoimmune conditions. As a result, BDCA2 has been explored as a potential therapeutic target
for autoimmune and inflammatory disorders, such as SLE and CLE.
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Market Opportunities of BDCA2 ADCs
Systemic Lupus Erythematosus
Systemic lupus erythematosus is an autoimmune disease characterized by the production
of autoantibodies that target the body’s own tissues and cells. It is the most common type of
lupus, causing widespread inflammation and tissue damage in the affected organs. The global
prevalence of SLE grew from 7,632.8 thousand cases in 2018 to 8,048.8 thousand cases in
2023. It is projected to increase to 8,800.3 thousand cases by 2032. In China, the prevalence
of SLE grew from 1,015.6 thousand cases in 2018 to 1,048.3 thousand cases in 2023. It is
projected to increase to 1,078.3 thousand cases by 2032.
The charts below set forth the treatment paradigm for SLE in China and the U.S.
Treatment Paradigm for SLE in China
Sequence of
medication
Before
After
SLE
Long-term use of hydroxychloroquine, for SLE
patients without contraindications
Glucocorticoids
Immunosuppressive Agents, used when
combination therapy with glucocorticoids and
hydroxychloroquine is ineffective
Biologics, for patients who are ineffective, intolerant,
or relapse after treatment with
glucocorticoids and/or immunosuppressants
Other Measures, such as plasma
exchange/immunoadsorption, immunoglobulin
therapy and tripterygium wilfordii
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Treatment Paradigm for SLE in the U.S.
First Line
Disease
Progression
Second Line
Third Line &
beyond
Disease
Progression
SLE
• Anifrolumab
• Belimumab
• Cyclophosphamide
• Mycophenolate mofetil
• Rituximab
• Voclosporin
• Glucocorticoids
• Hydroxychloroquine
• Nonsteroidal anti-inflammatory drugs
• Azathioprine
• Methotrexate
Source: Guidelines for Diagnosis and Treatment of Systemic Lupus Erythematosus, Systemic Lupus Erythematosus:
Diagnosis and Treatment, Frost & Sullivan
In China, long-term use of hydroxychloroquine is the primary treatment for SLE patients
without contraindications, followed by glucocorticoids. Immunosuppressive agents are used in
second-line setting when combination therapy with glucocorticoids and hydroxychloroquine is
ineffective. For patients who are ineffective, intolerant, or relapse after treatment with
glucocorticoids and/or immunosuppressants, biologics are recommended.
In the U.S. first-line treatment options for SLE mainly include (i) glucocorticoids, (ii)
hydroxychloroquine, and (iii) NSAIDs. Azathioprine and methotrexate are recommended as
second-line treatments. Third-line treatments include anifrolumab, belimumab,
cyclophosphamide, mycophenolate mofetil, rituximab and voclosporin.
With advancements in diagnostic tools and treatment options, the prognosis for
individuals with SLE has improved significantly over the past few decades. However, SLE
remains a chronic and potentially life-threatening condition, and calls for innovative treatment
options with improved efficacy. A major shortcoming of mainstay treatments for SLE, such as
glucocorticoids and immunosuppressants, is their inability to address the high heterogeneity of
pathogenesis in these complex diseases, which often result in limited efficacy and serious side
effects, especially when used long term for chronic disease management. Given the complex
and heterogeneous nature of SLE, an ideal treatment modality for SLE should be able to
achieve optimal disease control and minimize long-term side effects, calling for the
development of targeted therapies such as ADCs. As a validated target that is specifically
expressed on pDCs, BDCA2 and its over-production of type I interferon (“ IFN-I ”) are crucial
in SLE pathogenesis, making BDCA2-targeted ADCs promising for the treatment of SLE.
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Cutaneous Lupus Erythematosus
CLE is an autoimmune disorder that primarily affects the skin. CLE is characterized by
a range of inflammatory skin lesions and rashes that can appear on various parts of the body,
including the face, scalp, arms, and trunk. The global annual incidence of CLE remained
relatively stable at approximately 330 thousand cases from 2018 to 2023, and is projected to
reach 363.4 thousand cases in 2032. In China, the incidence of CLE grew from 55.8 thousand
cases in 2018 to 57.2 thousand cases in 2023, and is projected to remain at an annual incidence
of approximately 58 thousand cases from 2023 to 2032.
The charts below set forth the treatment paradigm for CLE in China and the U.S.
Treatment Paradigm for CLE in China
First Line
Disease
Progression
Second Line
Third Line &
beyond
Disease
Progression
CLE
• Methotrexate
• Mycophenolate mofetil
• Medical plant extracts
• Hydroxychloroquine
• Glucocorticoids
• Thalidomide
• Retinoids
• Dapsone
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Treatment Paradigm for CLE in the U.S.
CLE
First Line
Second Line &
beyond
Disease
Progression
• Oral antimalarial medication, such as
 hydroxychloroquine, chloroquine and quinacrine
• Topical corticosteroids
• Oral retinoids such as acitretin and isotretinoin
• Methotrexate
• Dapsone
• Mycophenolate mofetil
• Thalidomide/lenalidomide/iberdomide
Source: An Update on the Management of Refractory Cutaneous Lupus Erythematosus, Guidelines for Diagnosis and
Treatment of Cutaneous Lupus Erythematosus, Frost & Sullivan
In China, first-line systematic therapy for CLE patients is hydroxychloroquine.
Glucocorticoids, thalidomide, retinoids and dapsone are used as second-line treatments.
Third-line treatments include methotrexate, mycophenolate mofetil. In the U.S., first-line
systemic therapy for CLE patients is the use of an oral antimalarial medication. In second-line
settings, oral retinoids such as acitretin and isotretinoin, immunosuppressants such as
methotrexate are recommended.
Despite the available treatment options, many patients continue to experience suboptimal
disease control, highlighting the need for more effective and targeted therapies such as ADCs
to improve outcomes for individuals living with this debilitating autoimmune skin condition.
As a validated target that is specifically expressed on pDCs, BDCA2 and its over-production
of IFN-I are crucial in CLE pathogenesis, making BDCA2-targeted ADCs promising for the
treatment of CLE.
Competitive Landscape
As of the Latest Practicable Date, there were no approved BDCA2 ADCs and no BDCA2
ADCs under clinical development globally.
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REPORT COMMISSIONED BY FROST AND SULLIV AN
In connection with the Global Offering, we have engaged Frost & Sullivan to conduct a
detailed analysis and 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 which was founded in 1961 and is based in the United States. We have
agreed to pay Frost & Sullivan a total fee of approximately RMB0.6 million for the preparation
of the F&S Report, and we believe that such fees are consistent with the market rate. The
payment of such amount is not contingent upon our successful Listing or on the results 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 F&S 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 F&S Report may be
affected by the accuracy of the foregoing key assumptions.
The Directors and Joint Sponsors have exercised reasonable care in selecting and
identifying the named information sources, compiling, extracting and reproducing the
information, and in ensuring that there is no material omission of the information.
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PRC REGULATION
We are subject to a variety of PRC laws, rules and regulations across a number of aspects
of our business. This section sets forth a summary of the most significant laws and regulations
that are applicable to our current business activities within the territory of the PRC.
REGULATIONS ON FOREIGN INVESTMENT
Investment activities in the PRC by foreign investors are principally governed by the
Catalog of Encouraged Industries for Foreign Investment (ོᎸ̮ਠҳ༟ପุͦ፽) (the
“Encouraged Catalog ”), and the Special Administrative Measures (Negative List) for Foreign
Investment Access (݄(૶ఊ)) (the “ Negative List ”), which
are promulgated and amended from time to time by the MOFCOM and the National
Development and Reform Commission (the “ NDRC ”), and together with the Foreign
Investment Law of PRC () (the “ FIL”) and its respective
implementation rules and ancillary regulations.
In March 2019, the FIL was promulgated by National People’s Congress (the “ NPC”) and
came into effect on January 1, 2020, which replaced three then existing laws on foreign
investments in China, namely, the Sino-Foreign Equity Joint V enture Enterprise Law of PRC
(), the Sino-Foreign Cooperative Joint V enture
Enterprise Law of PRC () and the Wholly Foreign-
owned Enterprise Law of PRC (). The FIL, by means of
legislation, establishes the basic framework for the access, promotion, protection and
administration of foreign investment in view of investment protection and fair competition.
According to the FIL, foreign investment shall enjoy pre-entry national treatment, except for
those foreign invested entities that operate in industries deemed to be either “restricted” or
“prohibited” in the “negative list”, and the State Council shall promulgate or approve a list of
special administrative measures for access of foreign investments. To ensure the effective
implementation of the FIL, the Regulations on Implementing the Foreign Investment Law of the
PRC (ૢԷ) (the “ Implementation Regulations ”), was
promulgated by State Council in December 2019 and came into effect on January 1, 2020,
which further clarified that the state encourages and promotes foreign investment, protects the
lawful rights and interests of foreign investors, regulates foreign investment administration,
continues to optimize foreign investment environment, and advances a higher-level opening.
In December 2019, the MOFCOM and the SAMR promulgated the Measures on
Reporting of Foreign Investment Information (), which came into
effect in January 2020. After the Measures on Reporting of Foreign Investment Information
came into effect, the Interim Measures for the Administration of Filing for Establishment and
Changes in Foreign Investment Enterprises ()
have been repealed simultaneously. Since January 1, 2020, for foreign investors carrying out
investment activities directly or indirectly in China, the foreign investors or foreign-invested
enterprises shall submit investment information to the relevant commerce administrative
authorities according to the Measure on Reporting of Foreign Investment Information.
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According to the Measures for the Security Review of Foreign Investment (̮ਠҳ༟τ
) promulgated by the NDRC and the MOFCOM on December 19, 2020 and
became effective on January 18, 2021, any foreign investment that has or possibly has an
impact on state security shall be subject to security review in accordance with the provisions
hereof. A foreign investor or a party concerned in China shall take the initiative to make a
declaration to the working mechanism office prior to making the investment in any important
infrastructure, important transportation services and other important fields that concern state
security while obtaining the actual control over the enterprises invested in.
REGULATIONS ON PHARMACEUTICAL PRODUCT
Drug Regulatory Regime
The Drug Administration Law of the PRC () (the “ Drug
Administration Law ”) was promulgated by the Standing Committee of the NPC (the
“SCNPC ”), in September 1984, last amended on August 26, 2019 and became effective on
December 1, 2019. The Implementation Regulations of the Drug Administration Law of the
PRC (ૢԷ) (the “ Implementation Regulations ”) was
promulgated by the State Council in August 2002, and was last amended in December 2024,
and became effective on January 2025. The Drug Administration Law and the Implementation
Regulations have jointly established the legal framework for the administration of
pharmaceutical products in the PRC, including the research, development and manufacturing
of drugs. The Drug Administration Law applies to entities and individuals engaged in the
development, production, trade, application, supervision and administration of pharmaceutical
products, which regulates and provides for a framework for the administration of
pharmaceutical manufacturers, pharmaceutical trading companies and medicinal preparations
of medical institutions, and the development, research, manufacturing, distribution, packaging,
pricing and advertisements of pharmaceutical products. The Implementation Regulations, at
the same time, provides the detailed implementation regulations on the Drug Administration
Law.
In 2017, the drug regulatory system entered a new and significant period of reform. The
General Office of the State Council and the General Committee of China Communist Party
jointly issued an Opinions on Deepening the Reform of the Evaluation and Approval Systems
and Encouraging Innovation on Drugs and Medical Devices (ོ
จԈ) (the “ Innovation Opinions ”) in October 2017. According to
the Innovation Opinions, institutions for drug clinical trials should establish an independent
ethics committee and the clinical trial schemes are subject to examination, approval and
signing with approval opinions by the ethics committee before implementation, in order to
protect the rights and interests of human subjects in clinical trials. For a multi-center clinical
trial conducted in the PRC, after ethical review by the leader unit of clinical trial, other member
units should recognize the review results of the leader unit and may not conduct repeated
review. In addition, the expedited programs, the record-filing system, the prioritized review
mechanism, the acceptance of foreign clinical data under the Innovation Opinions and other
recent reforms encourage drug marketing authorization holders to seek marketing approval in
China first for the development of drugs in highly prioritized therapeutic areas such as
oncology or rare disease areas.
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To implement the regulatory reform introduced by Innovation Opinions, the SCNPC and
the NMPA as well as other authorities, are currently responsible for revising the laws,
regulations and rules regulating the pharmaceutical products and the industry.
Application for Clinical Trial
According to the Decision on Adjusting the Approval Procedures of Certain
Administrative Approval Items for Drugs (Ӕ
) promulgated by the China Food and Drug Administration (currently known as the
NMPA) on March 17, 2017, the decision on the approval of clinical trials of drugs shall be
made by the Center for Drug Evaluation (“ CDE”) from May 1, 2017. According to the
Administrative Measures for Drug Registration () (the “ Registration
Measures ”), which was promulgated on January 22, 2020 and took effect on July 1, 2020, drug
clinical trials shall be divided into Phase 1 clinical trial, Phase 2 clinical trial, Phase 3 clinical
trial, Phase 4 clinical trial, and bioequivalence trial. After the completion of the
pharmaceutical, pharmacological and toxicological research of the drug clinical trial, the
applicant may submit relevant research materials to CDE for applying for the approval to
conduct drug clinical trial. The CDE will organize pharmaceutical, medical and other
technicians to review the application and to decide whether to approve the drug clinical trial
within 60 days of the date of acceptance of the application. Once the decision is made, the
result will be notified to the applicant through the website of the CDE and if no notice of
decision is issued within the aforementioned time limit, the application of clinical trial shall
be deemed as approval. In accordance with Registration Measures and the Announcement on
Adjusting Evaluation and Approval Procedures for Clinical Trials for Drugs (ي
ʮѓ) issued in July 2018, if a clinical trial applicant does not
receive any negative or questioned opinions from the CDE within 60 days after the date when
the trial application is accepted and the fees are paid, the applicant can proceed with the
clinical trial in accordance with the trial protocol submitted to the CDE.
The Registration Measures further requires that the applicant shall, prior to conducting
the drug clinical trial, register the information of the drug clinical trial plan, etc. on the Drug
Clinical Trial Information Platform. After obtaining the approval of clinical trial, the applicant
must complete the clinical trial registration at the Drug Clinical Trial Information Platform for
public disclosure in accordance with the Circular on Drug Clinical Trial Information Platform
(ʮѓ), which came into effect in September 2013. The
applicant shall complete the trial pre-registration within one month after obtaining the approval
of the clinical trial application in order to obtain the trial’s unique registration number and
complete registration of certain follow-up information before the first subject’s enrollment in
the trial. If the registration is not completed within one year after the approval, the applicant
shall submit an explanation, and if the first submission is not completed within three years, the
approval of the clinical trial application shall automatically expire. During the drug clinical
trials, the applicant shall update registration information continuously, and register information
of the outcome of the drug clinical trial upon completion.
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Accelerated Approval for Clinical Trial and Registration
The Opinions on the Reform of Evaluation and Approval System for Drugs and Medical
Devices (จԈ) issued by the State Council on
August, 2015, established a reform framework of the evaluation and approval system for drugs
and medical devices, and indicated the tasks of enhancing the standards of approval for drug
registration, accelerating the evaluation and approval process for innovative drugs, and
improving the approval for clinical trials of drugs, etc.
The China Food and Drug Administration (currently known as the NMPA) released the
Circular Concerning Several Policies on Drug Registration Review and Approval (ۜ
ʮѓ) in November 2015, which clarified the measures and policies
regarding simplifying and accelerating the approval process of clinical trials, including but not
limited to an one-time approval procedure allowing the overall approval of all phases of a
drug’s clinical trials, replacing the phase-by-phase application and approval.
The Innovation Opinions established a framework for reforming the evaluation and
approval system for drugs, medical devices and equipment. The Innovation Opinions indicated
enhancing the standard of approval for drug marketing registration and accelerating the
evaluation and approval process for innovative drugs as well as improving the approval of drug
clinical trials.
According to the Announcement on Matters Concerning the Optimization of Drug
Registration Review and Approval (ʮѓ) jointly
issued by the NMPA and the NHC in May 2018, the CDE will prioritize the allocation of
resources for review, inspection, examination and approval of registration applications that
have been included in the scope of fast track clinical trial approval.
In July 2020, the NMPA issued the Review and Approval Procedures for Conditional
Approval of Drug Marketing Applications (Trial Implementation) (ɪ̹͡ሗ
ᄲ൙ᄲҭʈЪ೻ҏ(༊Б)), pursuant to which and the Registration Measures, an applicant
may submit, during the stage of clinical trials, an application for conditional approval, for
pharmaceuticals which fall under the following circumstances: (i) drugs for treatment of
life-threatening illnesses for which there is no effective treatment, whose clinical trial has data
to prove efficacy and to forecast the clinical value thereof; (ii) drugs urgently needed for public
health, whose clinical trial has data to prove efficacy and to forecast the clinical value thereof;
and (iii) other vaccines urgently needed for major public health emergencies or deemed by the
NHC to be urgently needed, which has been concluded upon evaluation that the benefits
outweigh the risks. For applications for a conditional approval, the applicant shall
communicate with the CDE on the conditional approval criteria for marketing and the
post-marketing research work to be continued and completed, and apply for drug marketing
authorization upon communication and confirmation. If it is concluded that the conditional
approval requirements are complied with, the drug registration certificate shall state the
validity period of the drug registration with conditional approval, the post-marketing research
work to be continued and completed and the deadline to complete such work, etc. For the drug
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which is granted with conditional approval, the holder shall adopt the appropriate risk
management measures following marketing of the drug, and complete the drug clinical trial and
relevant post-marketing research within the stipulated period, and declare so to the CDE via a
supplementary application.
In July 2020, NMPA issued the Priority Review and Approval Procedures for Drug
Marketing Authorizations (Trial Implementation) (ɪ̹஢̙Ꮄ΋ᄲ൙ᄲҭʈЪ೻ҏ(༊
Б)), at the time of application for drug marketing authorization, the following drugs which
have obvious clinical value may apply for prioritized review and approval procedures: (i)
clinically and urgently needed but insufficient drugs, innovative drugs and improved new drugs
for prevention and treatment of major contagious diseases and rare diseases; (ii) new pediatric
use pharmaceutical products, dosage form and specifications 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
therapy designation; (v) drugs which comply with conditional approval criteria; and (vi) other
circumstances entitled to prioritized review as stipulated by the NMPA. Upon communication
and confirmation with the CDE, when the applicant submits the application for drug marketing
authorization, the applicant shall simultaneously submit an application for prioritized review
and approval. If an application satisfies one of the foregoing criteria, the CDE shall announce
so and admit the application in the prioritized review and approval procedures. The following
policy support shall be granted to an application for drug marketing authorization admitted in
the prioritized review and approval procedures: (i) the review period shall be limited to no
more than 130 days; (ii) for clinically and urgently needed imported drugs for rare diseases
which are not yet marketed in the PRC, the review period shall be limited to no more than 70
days; (iii) priority shall be granted to examination, inspection and approval of the commonly
used name of drugs (if applicable); and (iv) upon communication and confirmation,
supplementary supporting materials may be required.
Conduct of Clinical Trial
After obtaining clinical trial approval, the applicant shall conduct clinical trials at
qualified clinical trial institutions. The qualified clinical trial institution refers to institutions
that have the conditions to conduct clinical trials in accordance with the requirements and
technical guidelines set forth in the Regulations for the Administration of Drug Clinical Trial
Institutions (), which came into effect on December 1, 2019.
Such clinical trial institutions shall be subject to filing requirements, with the exception of
institutions that only engage in analysis of biological samples which shall not be subject to
such filing requirements. The NMPA is responsible for setting up a filing management
information platform for the registration, filing and operation management of drug clinical trial
institutions, as well as the entry, sharing and disclosure of information from the supervision
and inspection activities conducted by the drug regulatory authorities and competent healthcare
authorities.
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The applicant filing an application for clinical drug trial after completing the
pharmaceutical research, pharmacological and toxicological research, and other researches
supporting clinical drug trial shall submit relevant research materials according to the
requirements for the application materials. The applicant who intends to carry out a
bioequivalence test shall, after undergoing the recordation formalities for bioequivalence test
at the website of the CDE as required, carry out relevant research work according to the plan
recorded. The applicant who is approved to carry out clinical drug trial shall, before carrying
out subsequent clinical drug trial by stages, develop corresponding plan for clinical drug trial,
carry out clinical drug trial upon examination and with consent of the ethics committee, and
submit corresponding plan for clinical drug trial and supporting materials on the website of the
Center for Drug Evaluation. Where indications (or functions) are intended to be added for a
drug approved for clinical drug trial and the use of a drug in combination with other drugs is
added, the applicant shall file a new application for clinical drug trial, and may only carry out
new clinical drug trial with approval.
The Announcement on Issuing the Guidelines for General Considerations for Clinical
Trials on Drugs (ஷѓ) promulgated by the
NMPA in January 2017 provides technical guidelines for applicants and investigators in
formulating overall research and development plan of drugs and separate clinical trial and
provides references for evaluation of the technical standards of the drugs.
According to the Announcement on Adjusting Evaluation and Approval Procedures for
Clinical Trials for Drugs (ʮѓ), where the
application for clinical trial of new investigational drug has been approved, upon the
completion of Phases 1 and 2 clinical trials and prior to Phase 3 clinical trial, the applicant shall
submit the application for communication meetings to CDE to discuss with CDE the key
technical questions including the design of Phase 3 clinical trial protocol. According to the
Administrative Measures for Communication on the Research, Development and Technical
Evaluation of Drugs (), revised by the NMPA on
December 10, 2020, during the research and development periods and in the registration
applications of, among others, the innovative new drugs, the applicants may propose to conduct
communication meetings with the CDE. The communication meetings can be classified into
three types. Type I meetings are convened to address key safety issues in clinical trials of drugs
and key technical issues in the research and development of breakthrough therapeutic drugs.
Type II meetings are held during the key research and development stages of drugs, mainly
including meetings before submitting the clinical trial application, meetings upon the
completion of Phase 2 trials and prior to Phase 3 trials, meetings before submitting the
marketing application for a new drug, and meetings for risk evaluation and control. Type III
meetings refer to other meetings not classified as Type I or Type II.
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Good Clinical Practices
Clinical trials must be conducted in accordance with the Good Clinical Practice for Drug
Trials (ᑗґ༊᜕ሯඎ၍ଣ஝ᇍ) (the “ GCP Rules ”) promulgated by NMPA and NHC
on April 23, 2020 and effective on July 1, 2020, which stipulates the requirements for the
procedures of conducting clinical trials, including preclinical trial preparation, trial protocols,
protection of testees’ rights and interests, duties of researchers, sponsors and monitors, as well
as data management and statistical analysis. According to the GCP Rules, clinical trial means
systematical investigation of drugs conducted on human subjects (patients or healthy
volunteers) to prove or reveal the clinical, pharmacological and other pharmacodynamic
effects, adverse reactions or absorption, distribution, metabolism and excretion of the drug
being investigated. In order to ensure the quality of clinical trials and the safety of human
subjects, the GCP Rules provides comprehensive and substantive requirements on the design
and conduct of clinical trials in the PRC. In particular, the GCP Rules enhances the protection
for study subjects and tightens the control over bio-samples collected under clinical trials.
The GCP Rules stipulated that the sponsor shall bear the expenses for medical treatment
and the corresponding compensation for any human subject who is harmed or dies due to
reasons connected with the clinical trial. The sponsor and investigator shall pay the human
subject the compensation or indemnification in a timely manner. However, the GCP Rules
promulgated in 2020 abolishes the compulsory insurance the sponsor provides to human
subjects participating in a clinical trial compared with the GCP Rules promulgated in 2003.
The GCP Rules also set out the qualifications and requirements for the investigators and
centers participating in clinical trial, including: (i) professional certification at a clinical trial
center, professional knowledge, training experience and capability of clinical trial, and being
able to provide the latest resume and relevant qualification documents per request; (ii) being
familiar with the trial protocol, investigator’s brochure and relevant information of the trial
drug provided by the applicant; (iii) being familiar with and comply with the Revised GCP
Rules and relevant laws and regulations relating to clinical trials; (iv) keeping a copy of the
authorization form on work allocation signed by investigators; (v) investigators and clinical
trial centers shall accept supervision and inspection organized by the applicant and inspection
by the drug regulatory authorities; and (vi) in the case of investigators and clinical trial centers
authorizing other individual or institution to undertake certain responsibilities and functions
relating to clinical trial, they shall ensure such individual or institution are qualified and
establish complete procedures to ensure the responsibilities and functions are fully performed
and generate reliable data.
The GCP Rules also summarizes the role of ethic committee in clinical trial process. An
ethic committee shall consist of experts working in the medical, pharmaceutical and other
fields. The clinical trial protocol may not be executed unless approved by the ethic committee.
Pursuant to the Announcement on Issuing the Guidelines for Ethical Review Work of Drug
Clinical Trials () promulgated by
State Food and Drug Administration (currently known as the NMPA) in November 2010, the
ethics committee shall carry out a review on the project of clinical trial on the drug to decide
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if it is rational in terms of science and ethics, and shall be subject to guidance and supervision
under the drug supervisory and administrative departments. The Regulations for the
Administration of Drug Clinical Trial Institutions also stipulates that each clinical trial
institution shall maintain an ethic committee responsible for the ethical review of drug clinical
trial.
Non-clinical Research
The non-clinical safety evaluation study for drugs for the purpose of applying for drug
registration shall be conducted in accordance with the Administrative Measures for Good
Laboratories Practice (Ӻሯඎ၍ଣ஝ᇍ), which was promulgated in August
2003 and amended in July 2017 by the China Food and Drug Administration (currently known
as the NMPA). In April 2007, the China Food and Drug Administration issued the Regulations
on the Certification Management of Good Laboratory Practice (Ӻሯඎ၍ଣ஝
), last amended on January 19, 2023 and taking effect on July 1, 2023, which
set forth the requirements for an institution to apply for a Certification of Good Laboratory
Practice to undertake non-clinical research on drugs.
Trial Exemptions and Acceptance of Foreign Data
The NMPA issued the Technical Guidance Principles on Accepting Foreign Drug Clinical
Trial Data () in July 2018, as one of the
implementing rules for the Innovation Opinions, which provides that overseas clinical data can
be submitted for the drug marketing registration applications in China. Such applications can
be in the form of waivers to China-based clinical trials, bridging trials and direct drug
marketing registration. According to the Technical Guidance Principles on Accepting Foreign
Drug Clinical Trial Data, sponsors may use the data of foreign clinical trials to support drug
marketing registration in China, provided that sponsors must ensure the authenticity, integrity,
accuracy and traceability of foreign clinical trial data and such data must be obtained consistent
with the relevant requirements under the Good Clinical Practice of the International
Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals
for Human Use (the “ ICH”). Moreover, sponsors shall ensure the scientific design of overseas
clinical trials, the compliance of clinical trial quality management system requirements, and
the accuracy and integrity of statistical analysis of data. To ensure that the clinical trial design
and statistical analysis of the data are scientific and reasonable, for the drugs with simultaneous
R&D at home and abroad and forthcoming clinical trials in China, the sponsors may, prior to
implementing registrational clinical trials, contact the CDE to ensure the compliance of
registrational clinical trials’ design with the essential technical requirements for drug
registration in China. Sponsors must also comply with other relevant sections of the
Registration Measures when applying for drug marketing registrations in China using foreign
clinical trial data.
The NMPA now officially permits, and its predecessor agencies have permitted on a
case-by-case basis in the past, drugs approved outside of China to be approved in China on a
conditional basis without pre-approval clinical trials being conducted in China. Specifically,
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the NMPA and the NHC released the Procedures for Reviewing and Approval of Clinical
Urgently Needed Overseas New Drugs (ʮѓ)
in October 2018, permitting drugs that have been approved within the last ten years in the
United States, the European Union or Japan and that prevent or treat orphan diseases or
prevent, or treat serious life-threatening illnesses for which there is either no effective therapy
in China, or for which the foreign-approved drug would have clear clinical advantages.
Applicants will be required to establish a risk mitigation plan and may be required to complete
trials in China after the drug has been marketed. The CDE has developed a list of qualifying
drugs that meet the foregoing criteria.
On November 15, 2021, the CDE introduced the Guiding Principles for Clinical Research
and Development of Anti-tumor Drugs Oriented by Clinical V alue (Ҥ
), for anti-tumor drugs, which states that the fundamental
purpose of the drug market is to address the needs of patients, and emphasizes that drug R&D
should be based on patient needs and clinical value.
New drug registration
Pursuant to the Registration Measures, upon completion of clinical trials, determination
of quality standards, completion of validation of commercial-scale production processes and
completion of other related preparation works, the applicant may apply with the NMPA for the
marketing authorization. The NMPA then determines whether to approve the application
according to applicable laws and regulations. The applicant must obtain the marketing
authorization for a new drag before the drug can be manufactured and sold in the China market.
Marketing Authorization Holder Mechanism
Pursuant to the Drug Administration Law, the PRC implements the marketing
authorization holder mechanism for management of the drug industry. The drug marketing
authorization holder refers to an enterprise or a drug research and development institution that
has obtained the drug registration certificate. The drug marketing authorization holder shall be
responsible for non-clinical research, clinical trials, production and operation, post-marketing
research, adverse reaction monitoring, reporting and processing of drugs in accordance with
the provisions of the law.
The marketing authorization holders may manufacture drugs by themselves or entrust a
pharmaceutical manufacturing enterprise to manufacture drugs. Likewise, they may sell drugs
by themselves or entrust a pharmaceutical distribution enterprise to sell drugs. However,
marketing authorization holders may not entrust a pharmaceutical manufacturing enterprise to
produce blood products, narcotic drugs, psychotropic drugs, medical-use toxic drugs or
pharmaceutical precursor chemicals, except as otherwise stipulated by the drug regulatory
department under the State Council.
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The drug marketing authorization holder shall establish a drug quality assurance system
and be equipped with special personnel to take charge of quality management on drugs
independently. The drug marketing authorization holder shall regularly review the quality
management system of the drug manufacturer and the drug distributor, and supervise its
continuous quality assurance and control capabilities. Where the marketing authorization
holder is an overseas enterprise, its designated domestic enterprise shall perform the
obligations of the marketing authorization holder and jointly assume responsibilities of the
marketing authorization holder with the overseas enterprise.
Approval or Filing of Human Genetic Resources
The Ministry of Science and Technology (the “ MST”) promulgated the Service Guide for
Administrative Licensing Items concerning Examination and Approval of Sampling, Collecting,
Trading or Exporting Human Genetic Resources, or Taking Such Resources out of the PRC
() in July 2015,
according to which, 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 Human Genetic Resources
Management Office of the PRC through the online system. The MST and the Human Genetic
Resources Management Office of the PRC further respectively promulgated the Circular on
Optimizing the Administrative Examination and Approval of Human Genetic Resources (ᗫ
) in October 2017 and the Circular on Further
Optimizing the Administrative Examination and Approval of Human Genetic Resources (ᗫ
) in October 2020, which simplify the
approval of sampling and collecting human genetic resources for the purpose of listing a drug
in the PRC.
The Regulations on the Administration of Human Genetic Resources of the PRC (ʕശ
ɛ͏΍ձ਷ɛᗳ፲ෂ༟๕၍ଣૢԷ), promulgated by the State Council in May 2019, latest
amended in March 2024 and came into effect in May 2024, further stipulates that 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 resource materials. However, the type,
quantity and usage of the human genetic resources to be used shall be filed with the
administrative department of health under the State Council before clinical trials. In May 2023,
the MST issued the Implementation Rules for the Administrative Regulation on Human Genetic
Resources (), which came into effect on July 1, 2023,
optimizing the scope of administrative licensing and record-keeping, enhancing the operability
of the human genetic resources administration system, and implementing the registration and
reporting system for the management of human genetic resources.
On October 17, 2020, the SCNPC promulgated the Biosecurity Law of the PRC (ʕശ
) (the “ Biosecurity Law ”) which became effective on April 15, 2021
and latest amended on April 26, 2024, establishing a comprehensive legislative framework on
the current regulations in the areas including prevention and control of outbreak of major
newly-emerged infectious diseases, animal and plant epidemics, security of biotechnology
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research, development and application, biosafety management of pathogenic microbiology
laboratories, security management of human genetic resources and biological resources,
prevention of the invasion of alien species and protection of biodiversity, 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; (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 administrative department of health 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, shall be
approved by the administrative department of health under the State Council.
REGULATIONS ON INFORMATION SECURITY AND DATA PROTECTION
According to the PRC Civil Code (Պ), the personal information
of an individual 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
safety of such information, and shall not illegally collect, use, process or transmit personal
information of others, or illegally purchase or sell, provide or make public personal
information of others. In addition, the processing of personal information shall follow the
principles of lawfulness, legitimacy and necessity.
On August 20, 2021, the SCNPC promulgated the Personal Information Protection Law
of the PRC (), or the Personal Information Protection
Law, which became effective on November 1, 2021. The Personal Information Protection Law
requires, among others, that the processing of personal information should have a clear and
reasonable purpose and should be limited to the minimum scope necessary to achieve the
processing purpose, adopt a method that has the least impact on personal rights and interests,
and shall not process personal information that is not directly related to the processing purpose.
The Interpretations of the Supreme People’ s Court and the Supreme People’ s
Procuratorate on Several Issues Concerning the Application of Law in the Handling of
Criminal Cases Involving Infringement of Citizens’ Personal Information (৫e
༆ᙑ), or the
Interpretations were promulgated on May 8, 2017 and became effective on June 1, 2017. The
Interpretations clarify several concepts regarding the crime of “infringement of citizens’
personal information” stipulated by Article 253A of the Criminal Law of the PRC (ʕശɛ
), including “citizens’ personal information”, “violation of relevant national
provisions”, “provision of citizens’ personal information” and “illegally obtaining any citizen’s
personal information by other methods”. In addition, the Interpretations specify the standards
for determining “serious circumstances” and “extraordinary serious circumstances” of this
crime.
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On June 10, 2021, the SCNPC promulgated the Data Security Law of PRC (ʕശɛ͏
), or the Data Security Law, which became effective on September 1,
2021. The Data Security Law mainly sets forth specific provisions regarding establishing basic
systems for data security management, including data classification and hierarchical protection
system, risk assessment system, monitoring and early warning system and emergency disposal
system. In addition, it clarifies the data security protection obligations of organizations and
individuals carrying out data activities and implementing data security protection
responsibility. The Data Security Law stipulates the measures to support and promote data
security and development, to establish and optimize the national data security management
system and to clarify organizations’ and individuals’ responsibilities in data security.
On November 7, 2016, the SCNPC promulgated the Cybersecurity Law of the PRC (ʕ
), which became effective on June 1, 2017, according to which,
network operators shall fulfill their obligations to safeguard the security of the network when
conducting business and providing services. Those who build, operate or provide services
through networks shall take technical measures and other necessary measures according to
laws, regulations and compulsory national standards to safeguard the safe and stable operation
of the networks, respond to network security incidents effectively, prevent illegal and criminal
activities, and maintain the integrity, confidentiality and usability of network data. The network
operator shall not collect personal information irrelevant to the services it provides or collect
or use the personal information in violation of the provisions of laws and regulations or
agreements concluded with its users.
On December 28, 2021, the Cyberspace Administration of China, or the CAC, jointly with
12 other administrative authorities, promulgated the revised Measures for Cybersecurity
Review (), or the MCR, which became effective on February 15, 2022.
According to the MCR, (i) CIIO that the purchase of cyber products and services or network
platform operators that engage in data processing activities that affects or may affect national
security shall be subject to the cybersecurity review by the Cybersecurity Review Office, the
department which is responsible for the implementation of cybersecurity review under the
CAC; (ii) network platform operators with personal information of more than one million users
that seek for listing in a foreign country are obliged to apply for a cybersecurity review by the
Cybersecurity Review Office; and (iii) the relevant regulatory authorities may initiate
cybersecurity review if such regulatory authorities determine that the issuer’s network products
or services, or data processing activities affect or may affect national security. On November
14, 2021, the CAC published the Administration Regulations on Cyber Data Security (Draft for
Comments) (ၣഖᅰኽτΌ၍ଣૢԷ(ᅄӋจԈᇃ)), which stipulated that data processing
entities should apply for cybersecurity review in the event that, among others, its listing in
Hong Kong affects or may affect national security. On September 30, 2024, the State Council
promulgated the Administration Regulations on Cyber Data Security (ၣഖᅰኽτΌ၍ଣૢ
Է) (the “ Data Security Regulations ”), which came into effect on January 1, 2025. The Data
Security Regulations reiterate and refine the general regulations for cyber data processing
activities, rules of personal information protection, important data security protection, cyber
data cross-border transfer management, and the responsibilities of online platform service
providers. In addition, the officially promulgated Data Security Regulations do not specifically
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include the requirement that cyber data processing entities seeking a listing in Hong Kong that
affects or may affect national security should apply for a cybersecurity review, as the
requirement originally set forth in the draft regulations published on November 14, 2021.
Instead, the officially promulgated regulations generally provide that cyber data processors
whose cyber data processing activities affect or may affect national security shall be subject to
national security review in accordance with the relevant regulations.
On July 7, 2022, the CAC promulgated the Measures for the Security Assessment of
Cross-border Data Transfer (), or the Security Assessment
Measures, which became effective on September 1, 2022. The Security Assessment Measures
provides four circumstances, under any of which data processors shall, through the local
cyberspace administration at the provincial-level, apply to the national cyberspace
administration for security assessment of cross-border data transfer. These circumstances
include: (i) where the important data are transferred to an overseas recipient; (ii) where the
personal information is transferred to an overseas recipient by a CIIO or a data processor that
has processed personal information of more than one million individuals; (iii) where a data
processor provides personal information to an overseas recipient if such data processor has
already provided overseas the personal information of 100,000 individuals or sensitive
personal information of 10,000 individuals in total since January 1 of the preceding year; or
(iv) other circumstances under which security assessment of outbound data transfer is required
as prescribed by the national cyberspace administration. In addition, on February 22, 2023, the
Measures for the Administration of Standard Contractual Clauses for the Cross-Border
Transfer of Personal Information (), or the SCC Measures,
were promulgated by the CAC, which took effect on June 1, 2023. The SCC Measures attach
the prescribed template for the standard contract on the outbound transfer of personal
information that could be used as an available option to satisfy the condition for cross-border
transfer of personal information under Article 38 of the Personal Information Protection Law.
On March 22, 2024, the CAC promulgated the Provisions on Promoting and Regulating
Cross-Border Data Flows (), effective on the date of
promulgation. The provisions provide several exemptions from undergoing data security
assessment, obtaining personal information protection certification or entering into standard
contract for outbound transfer of personal information for businesses. These exemptions
include, among others, the scenario where a data processor, other than a CIIO, has
cumulatively transferred overseas personal information, excluding sensitive personal
information, of fewer than 100,000 individuals since January 1 of the current year. A data
processor, other than a CIIO, shall enter into a standard contract with overseas recipients for
the cross-border transfer of personal information or obtain certification for personal
information protection if since January 1 of the current year, the data processor has
cumulatively transferred to overseas recipients (a) personal information of more than 100,000
but less than 1,000,000 individuals, excluding sensitive personal information, or (b) sensitive
personal information of less than 10,000 individuals. The provisions also explicitly state that
data processors are not required to conduct data security assessment for cross-border transfer
of important data if the data has not been notified or published as important data by relevant
departments or regions.
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REGULATIONS ON INTELLECTUAL PROPERTY
In terms of international conventions, the PRC has entered into (including but not limited
to) the Agreement on Trade-Related Aspects of Intellectual Property Rights (ٙ
), the Paris Convention for the Protection of Industrial Property (ᚐʈ
), the Madrid Agreement Concerning the International Registration of
Marks () and the Patent Cooperation Treaty (ਖ਼лΥЪૢ
).
Patent
In accordance with the Patent Law of the PRC (),
promulgated by the SCNPC, which was latest amended in October 2020 and became effective
on June 1, 2021, and the Implementation Rules of the Patent Law of the PRC (ʕശɛ͏΍
), which were promulgated by the State Council on June 15, 2001 and
last amended on December 11, 2023 and became effective on January 20, 2024, patent is
divided in to 3 categories, i.e., invention patent, design patent and utility model patent. The
duration of invention patent right, design patent right and utility model patent right shall be 20
years, 15 years and 10 years, respectively, which all calculated from the date of application.
Implementation of a patent without the authorization of the patent holder shall constitute an
infringement of patent rights, and shall be held liable for compensation to the patent holder and
may be imposed a fine, or even subject to criminal liabilities.
Specifically, for the purpose of compensating for the time taken to evaluate and approve
a new drug to be put on market, the patent administrative department under the State Council
shall grant compensation for duration of patent rights for invention of a new drug approved to
be put on market in China upon request of the patentee. The compensation period shall not
exceed five years, and the total validity period of patent rights for a new drug after being
approved for marketing shall not exceed 14 years.
Patent Transfer and License
Patent transfer (patent assignment) and patent license are two different ways of
transferring or granting rights of a patent. Patent assignment refers to the transfer of ownership
of a patent from one party (assignor) to another (assignee). The party who receives the
assignment (assignee) becomes the new owner of the patent, has the entire right to enforce it
and collect any damages for infringement. In countries like the PRC, patent assignment needs
to be recorded with the patent office and announced to public, before it takes effect. On the
other hand, patent license grants permission to another party (licensee) to use a patent, but
ownership of the patent remains with the original owner (licensor). The licensee is allowed to
use the patent subject to the terms of the license agreement, which may specify limitations on
territory, field, scope and/or duration of use. In the PRC, the recordal of a patent license
agreement is not mandatory.
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Patent Enforcement
Unauthorized use of patents without consent from owners of patents, forgery of the
patents belonging to other persons, or engagement in other patent infringement acts, will
subject the infringers to infringement liability. Serious offences such as forgery of patents may
be subject to criminal penalties.
A patent owner, or an interested party who believes the patent is being infringed, may
either file a civil legal suit or file an administrative complaint with the relevant patent
administration authority. A PRC court may issue a preliminary injunction upon the patent
holder’s or an interested party’s request before instituting any legal proceedings or during the
proceedings. Damages for infringement are calculated as the loss suffered by the patent holder
arising from the infringement or the benefit gained by the infringer from the infringement. If
it is difficult to ascertain damages in this manner, damages may be determined by using a
reasonable multiple of the license fee under a contractual license. If willful patent infringement
is found with serious circumstances, the damages may be increased to an amount between one
and five times the amount determined as per the aforementioned calculation method. Statutory
damages may be awarded in the circumstances where the damages cannot be determined by the
above-mentioned calculation standards. The damage calculation methods shall be applied in
the aforementioned order.
Trade Secrets
According to the Anti-Unfair Competition Law, the term “trade secrets” refers to
technical and business information that is unknown to the public, has utility, may create
business interests or profits for its legal owners or holders, and is maintained as a secret by its
legal owners or holders. Under the PRC Anti-Unfair Competition Law, business persons are
prohibited from infringing others’ trade secrets by: (i) obtaining the trade secrets from the legal
owners or holders by any unfair methods such as theft, bribery, fraud, coercion, electronic
intrusion, or any other illicit means; (ii) disclosing, using or permitting others to use the trade
secrets obtained illegally under item (i) above; (iii) disclosing, using or permitting others to use
the trade secrets, in violation of any contractual agreements or any requirements of the legal
owners or holders to keep such trade secrets in confidence; or (iv) instigating, inducing or
assisting others to violate confidentiality obligation or to violate a rights holder’s requirements
on keeping confidentiality of trade secrets, disclosing, using or permitting others to use the
trade secrets of the rights holder. If a third party knows or should have known of the
above-mentioned illegal conduct but nevertheless obtains, uses or discloses trade secrets of
others, the third party may be deemed to have committed a misappropriation of the others’ trade
secrets. The parties whose trade secrets are being misappropriated may petition for
administrative corrections, and regulatory authorities may stop any illegal activities and fine
infringing parties.
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Trademark
According to the Trademark Law of the PRC () promulgated
by SCNPC on August 23, 1982, most recently amended on April 23, 2019 and effective from
November 1, 2019, and the Implementation Regulation of the Trademark Law of the PRC (ʕ
ૢԷ) promulgated by the State Council on August 3, 2002, later
amended on April 29, 2014 and effective from May 1, 2014, registered trademarks are granted
a term of ten years which may be renewed for consecutive ten-year periods upon request by the
trademark owner. Trademark license agreements must be filed with the Trademark Office for
record, and the Trademark Law of the PRC has adopted a “first-to-file” principle with respect
to trademark registration. Conducts that shall constitute an infringement of the exclusive right
to use a registered trademark include but not limited to using a trademark that is identical with
or similar to a registered trademark on the same or similar goods without the permission of the
trademark registrant, and the infringing party will be ordered to stop the infringement act
immediately and may be imposed a fine. The infringing party may also be held liable for the
right holder’s damages, which will be equal to gains obtained by the infringing party or the
losses suffered by the right holder as a result of the infringement, including reasonable
expenses incurred by the right holder for stopping the infringement.
Copyright
According to the Copyright Law of the PRC () promulgated
by the SCNPC, which was latest amended in November 2020, and its related Implementing
Regulations, Chinese citizens, legal persons, or other organizations shall, whether published or
not, own copyright in their works, which include, among others, works of literature, art, natural
science, social science, engineering technology and computer software. Copyright owners of
protected works enjoy personal rights and property rights with respect to publication,
authorship, alteration, integrity, reproduction, distribution, lease, exhibition, performance,
projection, broadcasting, dissemination via information network, production, adaptation,
translation, compilation, and other rights shall be enjoyed by the copyright owners.
Domain Names
The Measures on Administration of Internet Domain Names ()
was promulgated by the MIIT in 2017, which adopts “first to file” rule to allocate domain
names to applicants, and provide that the MIIT shall supervise the domain names services
nationwide and publicize the PRC domain name system. After completion of the registration
procedures, the applicant will become the holder of the relevant domain name.
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REGULATIONS ON LEASING
According to the Civil Code, an owner of immovable or movable property is entitled to
possession, use, earnings, and disposal of such property in accordance with the law. Subject to
the consent of the lessor, the lessee may sublease the leased premises to a third party. Where
a lessee subleases the premises, the lease contract between the lessee and the lessor remains
valid. The lessor is entitled to terminate the lease if the lessee subleases the premises without
the consent of the lessor. In addition, if the ownership of the leased premises changes during
the lessee’s possession in accordance with the terms of the lease contract, the validity of the
lease contract shall not be affected. Moreover, pursuant to the Civil Code, if the mortgaged
property has been leased and transferred for occupation prior to the establishment of the
mortgage right, the original tenancy shall not be affected by such mortgage right.
On December 1, 2010, the Ministry of Housing and Urban-Rural Development
promulgated the Administrative Measures on Leasing of Commodity Housing (ॡ༣
), which became effective on February 1, 2011. According to such measures, the
lessor and the lessee are required to complete property leasing registration and filing
formalities within 30 days from execution of the property lease contract with the development
authorities or real estate authorities of the municipality or county where the leased property is
located. If a company fails to do as aforesaid, it may be ordered to rectify within a stipulated
period, and if such company fails to rectify, a fine ranging from RMB1,000 to RMB10,000 may
be imposed on each lease agreement.
According to the Interpretation of the Supreme People’ s Court on Several Issues
concerning the Application of Law in the Trial of Cases about Disputes Over Lease Contracts
on Urban Buildings (2020 version) (΁Ո᜗
༆ᙑ(2020͍)), which took effect on January 1, 2021, if the
ownership of the leased premises changes during lessee’s possession in accordance with the
terms of the lease contract, and the lessee requests the assignee to continue to perform the
original lease contract, the PRC court shall support it, except that the mortgage right has been
established before the lease of the leased premises and the ownership changes due to the
mortgagee’s realization of the mortgage right.
REGULATIONS ON FIRE PROTECTION AND ENVIRONMENTAL PROTECTION
Fire Control
Pursuant to the Fire Control Law of the PRC () promulgated
by the SCNPC on April 29, 1998, and last amended on April 29, 2021 and effective therefrom,
the Department of Emergency Management under the State Council and the local people’s
governments at or above county level shall supervise and administer the matters of fire
protection, while the fire control and rescue institutions of such people’s governments shall be
responsible for implementation. The design of fire control of the construction projects must
comply with the national technical standards of fire control. If the design of fire control of a
construction project has not been examined pursuant to the relevant laws or failed to pass the
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examination, the construction of such project is not allowed. If a completed construction
project has not gone through the fire safety inspection or failed to satisfy the requirements of
fire safety upon inspection, such project is not allowed to be put to use or business. According
to Interim Regulations on Administration of Examination and Acceptance of Fire Control
Design of Construction Projects () issued by the
Ministry of Housing and Urban-Rural Development on April 1, 2020 and latest amended on
21 August, 2023, an examination system for fire control design and acceptance only applies to
special construction projects, and for other projects, a record-filing and spot check system
would be applied.
Environmental Protection
The Environmental Protection Law of the PRC () was
promulgated and effective on 26 December 1989, and most recently amended on 24 April 2014.
The Environmental Protection Law has been formulated for the purpose of protecting and
improving both the living and the ecological environment, preventing and controlling pollution
and other public hazards and safeguarding people’s health. According to the provisions of the
Environmental Protection Law, in addition to other relevant laws and regulations of the PRC,
the Ministry of Environmental Protection and its local counterparts are responsible for
administering and supervising environmental protection matters. Pursuant to the
Environmental Protection Law, construction projects that have environmental impact shall be
subject to environmental impact assessment.
Environment Impact Assessment
On 28 October 2002, the SCNPC promulgated the Environmental Impact Assessment Law
of PRC (), which was latest amended on 29 December
2018. According to the Environmental Impact Assessment Law, the State Council implemented
the environmental impact assessment to classify construction projects according to the impact
of the construction projects on the environment.
Pursuant to the Interim Measures for Environmental Protection Acceptance of Completed
Construction Projects () effective as of 20
November, 2017 and the Regulations on the Administration Construction Project
Environmental Protection (ᚐ၍ଣૢԷ), which was revised on 16 July
2017 and implemented on October 1, 2017, after the completion of a construction project for
which an environmental impact report or an environmental impact report form is required, the
construction entity shall, according to standards and procedures prescribed by the
environmental protection administrative authorities, conduct environmental protection
completion acceptance check and compile an acceptance check report. A construction project
for which an environmental impact report or an environmental impact report form is required
shall not be put into production or use until the environmental protection completion
acceptance check has been passed.
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On 30 November 2020, Ministry of Ecology and Environment of the PRC promulgated
the Classified Administration Catalogue of Environmental Impact Assessments for
Construction Project (2021 version) (ணධͦᐑྤᅂᚤ൙ᄆʱᗳ၍ଣΤ፽(2021و)),
which became effective on 1 January 2021. According to the Environmental Impact Assessment
Law, where a construction entity commenced construction prior to submission of the
environmental impact report and environmental impact statement of the construction project or
prior to resubmission of the environmental impact report and environmental impact statement,
the ecological environment authorities at the county level or above shall order it to stop the
construction, impose a fine of not less than 1% but not more than 5% of the overall investment
amount for such construction project according to the seriousness and consequences of such
violations, and order it to restore to the original status; and the person-in-charge and
responsible personnel of the construction project shall be liable to administrative sanctions in
accordance with laws.
Pollutant Discharges Permitting Administration
Pursuant to the provisions of the Regulation on the Administration of Permitting of
Pollutant Discharges (રϮ஢̙၍ଣૢԷ) promulgated on 24 January 2021, and the
Measures for Pollutant Discharge Permitting Administration ()
promulgated on April 1, 2024 and became effective on July 1, 2024, the PRC implements the
classified pollutant discharge permit management (i.e., key management, simplified
management and registration management) on pollutant discharges of enterprises based on
factors such as the volume of pollutants generated, the amount of pollutant discharged and the
degree of impact on the environment. Enterprises and other producers that are included in the
Classification Administration List of Pollutant Discharge Permits for Fixed Pollution Sources
(๕રϮ஢̙ʱᗳ၍ଣΤ፽) shall apply for and obtain a pollutant discharge
permit or fill in a pollutant discharge registration form within the prescribed time limit, and
shall not discharge pollutants without a pollutant discharge permit or filling in a pollutant
discharge registration form.
For any violation of the Regulation on the Administration of Permitting of Pollutant
Discharges and the Measures for Pollutant Discharge Permitting Administration, in accordance
with the Environmental Protection Law of the PRC, the Atmospheric Pollution Prevention and
Control Law of the PRC, the Water Pollution Prevention and Control Law of the PRC and other
laws and regulations, the environmental protection authorities have the right to order to make
corrections, restrict production, suspend production for rectification, and suspend business and
close down, and impose a fine. If a violation of the public security provisions is constituted,
it shall be punished for public security violation in accordance with the law. If a crime is
constituted, it shall be investigated for criminal liabilities in accordance with the law.
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Disposal of Hazardous Waste
Pursuant to the Law on the Prevention and Control of Environmental Pollution Caused by
Solid Waste of the PRC (), which was
promulgated by the SCNPC in 1995 and was latest amended on 29 April 2020, entities
generating hazardous waste shall store, utilise and dispose hazardous waste according to the
relevant requirements of the state and environmental protection standards, and shall not dump
or pile up hazardous waste without authorisation. Furthermore, it is forbidden to entrust
hazardous waste to entities without a permit for disposal, or else the competent ecological and
environmental authorities shall order it to make rectification, impose fines, confiscate illegal
gains, and in serious circumstance, order it to suspend business or close down upon the
approval of the government authorities.
REGULATIONS ON EMPLOYMENT AND SOCIAL WELFARE
Employment
The major PRC laws and regulations that govern employment relationship are the Labor
Law of the PRC (), the Labor Contract Law of the PRC (ʕശɛ
) (the “ Labor Contract Law ”) and its implementation, which impose
stringent requirements on the employers in relation to entering into fixed-term employment
contracts, hiring of temporary employees and dismissal of employees.
The Labor Contract Law, which became effective on January 1, 2008, primarily aims at
regulating rights and obligations of employment relationships, including the establishment,
performance, and termination of labor contracts. Pursuant to the Labor Contract Law, labor
contracts must be executed in writing if labor relationships are to be or have been established
between employers and employees. Employers are prohibited from forcing employees to work
above certain time limits and employers must pay employees for overtime work in accordance
with national regulations. In addition, employee wages must not be lower than local standards
on minimum wages and must be paid to employees in a timely manner.
In December 2012, the Labor Contract Law was amended to impose more stringent
requirements on the use of employees of temp agencies, who are known in China as
“dispatched workers”. Dispatched workers are entitled to equal pay with full-time employees
for equal work. Employers are only allowed to use dispatched workers for temporary, auxiliary
or substitutive positions. According to the Interim Provisions on Labor Dispatch (჆
) promulgated by the Ministry of Human Resources and Social Security and came
into effect on March 1, 2014, the number of dispatched workers hired by an employer may not
exceed 10% of the total number of its employees. Where rectification is not made within the
stipulated period, the employers may be subject to a penalty ranging from RMB5,000 to
RMB10,000 per dispatched worker exceeding the 10% threshold.
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Social Insurance
The Social Insurance Law of the PRC () (the “ Social
Insurance Law ”) issued by the SCNPC in 2010 and latest amended on December 29, 2018, has
established social insurance systems of basic pension insurance, basic medical insurance,
work-related injury insurance, unemployment insurance and maternity insurance and has
elaborated in detail the legal obligations and liabilities of employers who fail to comply with
relevant laws and regulations on social insurance. According to the Social Insurance Law and
the Provisional Regulations on Collection and Payment of Social Insurance Premiums (ٟ
ᎈ൬ᅄᖮᅲБૢԷ) promulgated by the State Council on January 22, 1999 and most
recently amended on March 24, 2019 and effective from the same date, enterprises shall
register social insurance with local social insurance and pay or withhold relevant social
insurance for or on behalf of its employees. Any employer that fails to make social insurance
contributions may be ordered to rectify the non-compliance and pay the required contributions
within a prescribed time limit and be subject to a late fee. If the employer still fails to rectify
the failure to make the relevant contributions within the prescribed time, it may be subject to
a fine ranging from one to three times the amount overdue.
Housing Provident Fund
In accordance with the Regulations on the Administration of Housing Provident Funds
(၍ଣૢԷ) promulgated by the State Council on April 3, 1999, and amended
on March 24, 2002, and March 24, 2019, enterprises must register at the designated
administrative centers and open bank accounts for depositing employees’ housing provident
funds. Employers and employees are also required to pay and deposit housing provident funds,
with an amount no less than 5% of the monthly average salary of the employee in the preceding
year in full and on time. In case of overdue payment or underpayment by employers, orders for
payment within a specified period will be made by the housing fund management center. Where
employers fail to make payment within such period, enforcement by the people’s court will be
applied.
In case of failure to register and open accounts for depositing employees’ housing
provident funds, the housing fund management center shall order employers to go through the
formalities within a specified period, where employers fail to do such formalities within the
prescribed time, a fine of not less than RMB10,000 nor more than RMB50,000 shall be
imposed.
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REGULATIONS ON FOREIGN EXCHANGE
Regulations relating to Foreign Currency Exchange
The principal regulations governing foreign currency exchange in China are the Foreign
Exchange Administration Regulations of the PRC (ʕശɛ͏΍ձ਷̮ි၍ଣૢԷ), most
recently amended in August 2008. Under the PRC foreign exchange regulations, payments of
current account items, such as profit distributions, interest payments and trade and service-
related foreign exchange transactions, can be made in foreign currencies without prior approval
from the SAFE, by complying with certain procedural requirements. By contrast, approval
from or registration with appropriate government authorities is required where Renminbi is to
be converted into foreign currency and remitted out of China to pay capital account items, such
as direct investments, repayment of foreign currency-denominated loans, repatriation of
investments and investments in securities outside of China.
The SAFE issued the Circular on Reforming of the Management Method of the Settlement
of Foreign Currency Capital of Foreign-Invested Enterprises (̮ਠ
) (the “ SAFE Circular 19 ”) on March 30, 2015,
and it became effective on June 1, 2015, which was partially repealed on December 30, 2019,
and latest amended on March 23, 2023. The SAFE Circular 19 expands a pilot reform of the
administration of the settlement of the foreign exchange capitals of foreign-invested
enterprises nationwide. In June 2016, SAFE further promulgated the Circular on the State
Administration of Foreign Exchange on Reforming and Standardizing the Foreign Exchange
Settlement Management Policy of Capital Account (ձ஝ᇍ༟͉ධ
) (the “ SAFE Circular 16 ”), which, among other things, amends
certain provisions of SAFE Circular 19. Pursuant to SAFE Circular 19 and SAFE Circular 16,
the flow and use of the Renminbi capital converted from foreign currency denominated
registered capital of a foreign-invested company is regulated such that Renminbi capital may
not be used for business beyond its business scope or to provide loans to persons other than
affiliates unless otherwise permitted under its business scope.
In October 2019, SAFE issued the Circular on Further Facilitating Cross-border Trade
and Investment () (the
“SAFE Circular 28 ”), which cancels the restrictions on domestic equity investments by capital
fund of non-investment foreign invested enterprises and allows non-investment foreign
invested enterprises to use their capital funds to lawfully make equity investments in China,
provided that such investments do not violate the Negative List and the target investment
projects are genuine and in compliance with laws. According to the Circular on Optimizing
Administration of Foreign Exchange to Support the Development of Foreign-related Business
() (the “ SAFE Circular 8 ”),
issued by SAFE in April 2020, under the prerequisite of ensuring true and compliant use of
funds and compliance with the prevailing administrative provisions on use of income under the
capital account, eligible enterprises are allowed to make domestic payments by using their
capital funds, foreign credits and the income under capital accounts of overseas listing, without
prior provision of the evidentiary materials concerning authenticity to the bank for each
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transaction. The handling banks shall conduct spot checks afterwards in accordance with the
relevant requirements. The interpretation and implementation in practice of SAFE Circular 28
and SAFE Circular 8 are still subject to substantial uncertainties given they are newly issued
regulations.
Foreign Exchange Registration of Offshore Investment by PRC Residents
The SAFE promulgated the Circular on Relevant Issues Concerning Foreign Exchange
Control on Domestic Residents’ Offshore Investment and Financing and Roundtrip Investment
through Special Purpose V ehicles (ʮ̡ྤ̮ҳ
) (the “ SAFE Circular 37 ”) in July 2014. The
SAFE Circular 37 requires PRC residents (including PRC institutions and individuals) must
register with local branches of SAFE in connection with their direct or indirect offshore
investment in an overseas special purpose vehicle (the “ SPV”) directly established or indirectly
controlled by PRC residents for the purposes of offshore investment and financing with their
legally owned assets or interests in domestic enterprises, or their legally owned offshore assets
or interests. Such PRC residents are also required to amend their registrations with SAFE when
there is a change to the basic information of the SPV , such as changes of a PRC resident
individual shareholder, the name or operating period of the SPV , or when there is a significant
change to the SPV , such as changes of the PRC individual resident’s increase or decrease of its
capital contribution in the SPV , or any share transfer or exchange, merger, division of the SPV .
Failure to comply with the registration procedures set forth in the SAFE Circular 37 may
result in restrictions being imposed on the foreign exchange activities of the relevant onshore
company, including the payment of dividends and other distributions to its offshore parent or
affiliate, the capital inflow from the offshore entities and settlement of foreign exchange
capital, and may also subject relevant onshore company or PRC residents to penalties under
PRC foreign exchange administration regulations.
Regulations relating to Stock Incentive Plans
Pursuant to the Circular on Issues Concerning the Foreign Exchange Administration for
Domestic Individuals Participating in Stock Incentive Plan of Overseas Publicly Listed
Company (ྌ̮ි၍ଣϞᗫਪᕚ
) (the “ SAFE Circular 7 ”), promulgated by SAFE in February 2012, employees,
directors, supervisors, and other senior management participating in any share incentive plan
of an overseas publicly-listed company who are PRC citizens or who are non-PRC citizens
residing in China for a continuous period of not less than one year, subject to a few exceptions,
are required to register with SAFE through a domestic agency. Moreover, an overseas-entrusted
institution must be retained to handle matters in connection with the exercise or sale of stock
options and the purchase or sale of shares and interests.
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The income of foreign exchange PRC residents by selling out the shares according to the
equity incentive plan and the dividend distributed by the overseas-listed company shall be
distributed to the PRC residents after being remitted to the bank account in China opened by
the domestic institutions.
REGULATIONS ON TAXATION
Enterprise Income Tax
According to the CIT Law, which was promulgated by the SCNPC and was latest
amended on December 29, 2018, and the Regulation on the Implementation of the CIT Law ,
which was promulgated by the State Council and was latest amended in April 2019, a uniform
25% enterprise income tax rate is imposed to both foreign invested enterprises and domestic
enterprises, except where tax incentives are granted to special industries and projects. The
enterprise income tax rate is reduced to 20% for qualifying small low-profit enterprises. The
high-tech enterprises that need full support from the PRC’s government will enjoy a reduced
tax rate of 15% for enterprise income tax.
Value-added Tax
Pursuant to the Provisional Regulations of the PRC on V alue-added Tax (ʕശɛ͏΍
೼ᅲБૢԷ), which was promulgated by the State Council and was latest amended
on November 19, 2017, and the Implementation Rules for the Provisional Regulations the PRC
on V alue-added Tax (), which was promulgated
by the Ministry of Finance and was latest amended on October 28, 2011 and effective from
November 1, 2011, entities and individuals engaging in selling goods, providing processing,
repairing or replacement services or importing goods within the territory of the PRC are
taxpayers of the value-added tax (“ VAT”).
According to the Notice of the Ministry of Finance and the State Taxation Administration
on the Adjusting V alue-added Tax Rates ( )
effective in May 2018, the V A T rates of 17% and 11% on sales, imported goods shall be
adjusted to 16% and 10%, respectively.
According to the Announcement of the Ministry of Finance, the State Taxation
Administration and the General Administration of Customs on Relevant Policies for Deepening
the V alue-Added Tax Reform (ഄ
ʮѓ) promulgated on March 20, 2019 and effective from April 1, 2019, the V A T rates of
16% and 10% on sales, imported goods shall be adjusted to 13% and 9%, respectively.
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Dividends Distribution
The principal laws, rules and regulations governing dividend distributions by foreign-
invested enterprises in the PRC are the Company Law, promulgated in 1993 and latest amended
in 2023, and the FIL and its Implementing Regulations. Under these requirements, foreign-
invested enterprises may pay dividends only out of their accumulated profit, if any, as
determined in accordance with PRC accounting standards and regulations. A PRC company is
required to allocate at least 10% of their respective accumulated after-tax profits each year, if
any, to fund certain capital reserve funds until the aggregate amount of these reserve funds have
reached 50% of the registered capital of the enterprises. A PRC company is not permitted to
distribute any profits until any losses from prior fiscal years have been offset. Profits retained
from prior fiscal years may be distributed together with distributable profits from the current
fiscal year.
REGULATIONS ON OVERSEAS LISTINGS
Overseas Listings
On February 17, 2023, the CSRC released several regulations regarding the management
of filings for overseas offerings and listings by domestic companies, including the Trial
Measures for the Administration on Overseas Securities Offering and Listing by Domestic
Companies () (the “ Overseas Listing Trial
Measures ”) together with 5 supporting guidelines (together with the Overseas Listing Trial
Measures, collectively referred to as the “ Overseas Listing Regulations ”). Under Overseas
Listing Regulations, PRC domestic companies that seek to offer and list securities in overseas
markets, either in direct or indirect means, are required to file the required documents with the
CSRC within three working days after its application for overseas listing is submitted.
Under the Overseas Listing Trial Measures, an issuer shall be deemed to have filed with
the CSRC for indirect overseas issuance and listing if the issuer meets the following
circumstances: (i) the operating revenues, total profits, total assets or net assets of the domestic
enterprise in the most recent fiscal year, with any one of the indicators accounting for more
than 50% of the relevant data in the issuer’s audited consolidated financial statements for the
same period; (ii) the major aspects of the operating activities are carried out in the territory or
the principal place of business is located in the territory, or the majority of the senior
management in charge of the operation and management are Chinese citizens or have their
usual place of residence in the territory. If an issuer submits an application for an initial public
offering to a foreign regulatory body, it shall file the application with the CSRC within three
working days after the application is made.
The Overseas Listing Regulations provides that no overseas offering and listing shall be
made under any of the following circumstances: (i) such securities offering and listing is
explicitly prohibited by provisions in laws, administrative regulations and relevant state rules;
(ii) the intended securities offering and listing may endanger national security as reviewed and
determined by competent authorities under the State Council in accordance with law; (iii) the
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domestic company intending to make the securities offering and listing, or its controlling
shareholders and the actual controller, have committed crimes such as corruption, bribery,
embezzlement, misappropriation of property or undermining the order of the socialist market
economy during the latest three years; (iv) the domestic company intending to make the
securities offering and listing is suspected of committing crimes or major violations of laws
and regulations, and is under investigation according to law and no conclusion has yet been
made thereof; or (v) there are material ownership disputes over equity held by the domestic
company’s controlling shareholder or by other shareholders that are controlled by the
controlling shareholder and/or actual controller. Additionally, the Overseas Listing Regulations
stipulates that after an issuer has offering and listing securities in an overseas market, the issuer
shall submit a report to the CSRC within three working days after the occurrence and public
disclosure of (i) a change of control thereof, (ii) investigations of or sanctions imposed on the
issuer by overseas securities regulators or relevant competent authorities, (iii) changes of
listing status or transfers of listing segment, and (iv) a voluntary or mandatory delisting.
Overseas offering and listing by domestic companies shall be made in strict compliance with
relevant laws, administrative regulations and rules concerning national security in spheres of
foreign investment, cybersecurity, data security and etc., and duly fulfill their obligations to
protect national security.
On February 24, 2023, the CSRC and three other relevant government authorities jointly
promulgated the Provisions on Strengthening the Confidentiality and Archives Administration
Related to the Overseas Securities Offering and Listing by Domestic Enterprises (̋੶
) (the “ Provision on
Confidentiality ”). Pursuant to the Provision on Confidentiality, where a domestic enterprise
provides or publicly discloses any document or material that involving state secrets and
working secrets of state agencies to the relevant securities companies, securities service
institutions, overseas regulatory authorities and other entities and individuals, it shall report to
the competent department with the examination and approval authority for approval in
accordance with the law, and submit to the secrecy administration department of the same level
for filing. The working papers formed within the territory of the PRC by the securities
companies and securities service agencies that provide corresponding services for the overseas
issuance and listing of domestic enterprises shall be kept within the territory of the PRC, and
cross-border transfer shall go through the examination and approval formalities in accordance
with the relevant provisions of the State.
As advised by our PRC Legal Advisor, we are required to submit filings with the CSRC
within three business days after we submit application for this Global Offering. As confirmed
by our Directors and our PRC Legal Advisor, we have submitted the filing with the CSRC
within the specific time limit as required by the Overseas Listing Regulations after our
submission of the application for this Global Offering to the Stock Exchange.
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OVERVIEW OF LA WS AND REGULATIONS IN THE UNITED STATES
This section summarizes the principal laws and regulations in the United States that are
relevant to our business.
Laws and Regulations in Relation to New Drug
U.S. Government Regulation of Drug and Biological Products
In the United States, the FDA regulates drugs under the FDCA and its implementing
regulations, and biologics under the FDCA and the Public Health Service Act 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 preclinical testing, which
includes laboratory evaluations of product chemistry, toxicity, formulation and stability, as
well as animal studies. Preclinical testing is conducted in accordance with FDA ’s Good
Laboratory Practice regulations. A sponsor of an IND must submit the results of the preclinical
tests, 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.
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 (the “ 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.
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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 1, phase
2 and phase 3, and may overlap.
 phase 1 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 2 clinical trials involve studies in 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 3 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.
Specifically for oncology drugs and biologics, in August 2018, the FDA, together with
other US competent authorities, introduced a draft guidance paper “Expansion Cohorts: Use in
First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics
Guidance for Industry”, which was formally adopted in March 2022. This guidance paper
acknowledges a new clinical trial design, which the FDA calls the first-in-human multiple
expansion cohort trial. These are trial designs that have a single protocol with an initial dose
escalation phase for the initial determination of a tolerated dose and multiple concurrently
accruing expansion cohorts with assessments that are more typical of phase 2 trials (i.e., to
assess anti-tumor activity). The new trial design is intended to efficiently expedite the clinical
development of oncology drugs, including biological products, through multiple expansion
cohort trial designs.
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 .
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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 cGMP requirements. The process of obtaining regulatory approvals and
compliance with appropriate federal, state, local and foreign statutes and regulations requires
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.
U.S. Review and Approval Processes
The results of product development, preclinical 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 a 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 cGMP-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 cGMP
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 (“ CR”) 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 CR 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 4 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 United States, 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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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 an 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 preclinical and clinical data is as efficient as practicable.
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. For
drugs under accelerated approval, the FDA grants priority review status, which aims to shorten
the review time to six months from the submission of a complete application. 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.
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.
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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.
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.
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
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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.
Proposed BIOSECURE Act
On December 20, 2023, members of the U.S. Senate introduced legislation to prohibit
federal contracting with certain biotechnology providers connected to foreign adversaries. On
March 6, 2024, the version of the legislation introduced in the U.S. Senate was advanced by
the Homeland Security and Governmental Affairs Committee for consideration by the full U.S.
Senate. On January 24, 2024, the U.S. House of Representatives proposed a similar version of
such legislation titled the BIOSECURE Act (the “ BIOSECURE Act ”). On May 15, 2024, the
BIOSECURE Act was advanced by the Committee on Oversight to the full U.S. House of
Representatives. On September 9, 2024, the U.S. House of Representatives voted in favor of
the BIOSECURE Act, which is currently now pending a vote in the full U.S. Senate.
The BIOSECURE Act, if enacted in its current form, would prohibit the U.S. government
from procuring biotechnology equipment or services from designated “biotechnology
companies of concern,” and would prohibit government contracts, loans and grants to any
entity that uses biotechnology equipment or services from a designated “biotechnology
company of concern.” The most recent House version of the legislation names five specific
Chinese companies as “biotechnology companies of concern,” namely BGI Group, MGI Tech
Co., Ltd., Complete Genomics, Inc., WuXi AppTec Co., Ltd., and WuXi Biologics (Cayman)
Inc., and any of their subsidiary, parent, affiliate, or successor. The U.S. government has the
authority to identify additional entities for inclusion as “biotechnology companies of concern,”
specifically any entity that is subject to the administrative governance structure, direction,
control, or operates on behalf of the government of a foreign adversary (defined by law to be
China, Iran, North Korea, and Russia), is involved in the manufacturing, distribution,
provision, or procurement of a biotechnology equipment or service, and poses a risk to the
national security of the U.S., based on (i) engaging in joint research with, being supported by,
or being affiliated with a foreign adversary’s military, internal security forces, or intelligence
agencies; (ii) providing multiomic data obtained via biotechnology equipment or services to
the government of a foreign adversary; or (iii) obtaining human multiomic data via the
biotechnology equipment or services without express and informed consent. In 2022, we
entered into a license agreement with WuXi Biologics Ireland Limited, an indirect wholly
owned subsidiary of WuXi Biologics (Cayman) Inc. (HKEX: 2269), in relation to the in-license
of a B7-H3 mAb. During the Track Record Period, we also procured CRO services from WuXi
Biologics (Cayman) Inc. through its subsidiaries.
REGULATORY OVERVIEW
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The most recent House version of the legislation would delay the application of the
BIOSECURE Act’s provisions (i) until January 1, 2032, with respect to biotechnology
equipment or services provided or produced by one of the named biotechnology companies of
concern under a contract or agreement entered before the effective date of the legislation; and
(ii) for a period of five years after the identification of new biotechnology companies of
concern, with respect to biotechnology equipment and services provided or produced by an
entity that the government identifies in the future as a biotechnology company of concern.
We will continue to closely monitor and evaluate the potential impacts of the proposed
BIOSECURE Act on our business and operations, including maintaining strong business
relationships with our existing suppliers and a list of qualified alternative suppliers capable of
providing equivalent services.
Laws and Regulations in Relation to Outbound Investment
On October 28, 2024, the U.S. Department of the Treasury issued final regulations (the
“Final Rule ”) to implement Executive Order 14105, “Addressing United States Investments in
Certain National Security Technologies and Products in Countries of Concern” (August 9,
2023). The Final Rule took effect on January 2, 2025, which prohibits or requires notification
of certain investments by “U.S. persons” or their foreign subsidiaries in “covered foreign
persons,” which are defined as certain individuals or entities associated with a country of
concern that are engaged in, or associated with parties engaged in, activities involving
semiconductors and microelectronics, quantum information technologies, or artificial
intelligence (including. The Final Rule applies if the covered foreign person or a related party
is working with specified technologies in one of these fields.
On February 21, 2025, U.S. President Donald J. Trump issued a memo entitled the
“America First Investment Policy” (the “ America First Memo ”), outlining the ongoing review
and consideration of potential new or expanded restrictions on U.S. outbound investment in the
PRC in sectors such as biotechnology, hypersonics, aerospace, advanced manufacturing, and
directed energy. The America First Memo also contemplates potential restrictions on
investments in publicly traded securities by pension funds, university endowments and other
limited partner investors. We will continue to monitor the future indications of such policies
and assess relevant risks.
REGULATORY OVERVIEW
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--- page 260 ---
OVERVIEW
We are a key player in the global ADC landscape, dedicated to the development of
innovative therapeutics in this fast-growing drug modality to treat cancer, autoimmune
diseases, and beyond. Our Company was established in July 2019 by our founder, Dr. ZHU
Zhongyuan, who has extensive entrepreneurial and managerial experience in the
pharmaceutical industry across China and the United States. With over 20 years of experience
spanning biotech entrepreneurship and venture investment, Dr. ZHU has cultivated extensive
relationships with founders, scientists, and industry experts across the biotech sector. His
network and industry expertise were instrumental in assembling our Company’s current
management team and advisory board. For the biographical information of Dr. ZHU, please
refer to the section headed “Directors and Senior Management” in this prospectus.
MILESTONES
The following table summarizes various key milestones in our corporate and business
development.
Y ear Milestone
2019 /H1118/H1118/H1118/H1118The Company was incorporated under the laws of the Cayman Islands.
2020 /H1118/H1118/H1118/H1118We commenced our operations in China.
We completed the Series Seed Financing.
We completed the Series A-1 Financing and the Series A-2 Financing.
We initiated our first ADC program DB-1303 (HER2 ADC).
2021 /H1118/H1118/H1118/H1118We commenced our operations in the U.S.
We received IND approval from FDA to launch the first-in-human study of
DB-1303 in the U.S.
2022 /H1118/H1118/H1118/H1118We completed the Series B Financing.
We received IND approval from NMPA to launch the first-in-human study
of DB-1303 in China.
We initiated the phase 1/2a global trial of DB-1303.
We received IND approvals from the FDA and NMPA for DB-1305 (TROP2
ADC) and initiated the first-in-human phase 1/2a global trial of DB-1305.
We entered into an out-license and collaboration agreement with Adcendo*
on December 23, 2022 on ADC assets utilizing our proprietary payload-
linkers derived from DITAC platform.
HISTORY AND CORPORATE STRUCTURE
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Y ear Milestone
2023 /H1118/H1118/H1118/H1118We completed the Series B+ Financing.
We received IND approvals from the FDA and NMPA for DB-1311 (B7-H3
ADC) and initiated the first-in-human phase 1/2a global trial of DB-1311.
We received IND approvals from the FDA and NMPA for DB-1310 (HER3
ADC) and initiated the first-in-human phase 1/2a global trial of DB-1310.
We entered into a global strategic partnership with BioNTech* on DB-1303,
DB-1311 and DB-1305 on March 16, 2023, March 31, 2023 and August 4,
2023, respectively.
We entered into an out-license and collaboration agreement with BeiGene*
on July 9, 2023 on DB-1312 (B7-H4 ADC).
We and BioNTech* initiated a global potential registrational study of
DB-1303 in HER2-expressing EC.
DB-1303 obtained Fast Track and Breakthrough Therapy Designations from
the FDA for the treatment of advanced EC in patients who progressed on or
after treatment with immune checkpoint inhibitors.
2024 /H1118/H1118/H1118/H1118We and BioNTech* initiated a phase 3 global registrational trial for
DB-1303 in chemo-naïve HR+/HER2-low metastatic BC.
We initiated a phase 3 registrational trial of DB-1303 in HER2+ BC in
China.
DB-1303 obtained Breakthrough Therapy Designation by the NMPA for the
treatment of advanced EC in patients who progressed on or after treatment
with immune checkpoint inhibitors.
DB-1305 was granted Fast Track Designation by the FDA for patients with
platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal
cancer.
DB-1311 received FDA Fast Track Designation for the treatment of patients
with advanced/unresectable, or metastatic CRPC and Orphan Drug
Designations for the treatment of ESCC and SCLC.
We received IND approval from the FDA to launch the phase 1/2a clinical
trial of DB-1419.
We initiated a phase 1 study in healthy adults for DB-2304 in Australia.
HISTORY AND CORPORATE STRUCTURE
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Y ear Milestone
We entered into an exclusive option agreement with GSK for DB-1324, a
preclinical asset developed with our DITAC platform.
We entered into a collaboration and license agreement with Avenzo,
pursuant to which we granted Avenzo an exclusive license to develop,
manufacture and commercialize DB-1418/A VZO-1418, our EGFR/HER3
BsADC, globally excluding Greater China.
2025 /H1118/H1118/H1118/H1118We entered into a collaboration agreement with 3SBio Inc. (HKEX: 1530,
“3SBio ”) through its subsidiaries, pursuant to which we have appointed
3SBio as our commercialization partner in Mainland China, Hong Kong, and
Macau to promote DB-1303 for certain indications.
We received IND approval for DB-1419 from the NMPA to initiate
DB-1419’s phase 1/2a trial in China.
We received IND approvals from the FDA and the NMPA for DB-2304’s
phase 1 global trial.
* Throughout its business development history, the Company has established strategic collaborations with
several biopharmaceutical companies, leveraging existing professional networks and industry events to
initiate discussions. These collaborations, including those with Adcendo, BioNTech, and BeiGene, were
formed through business development efforts.
CORPORATE HISTORY
Establishment and Major Shareholding Changes of Our Company
Our Company was incorporated as an exempted company with limited liability in the
Cayman Islands on July 3, 2019. The initial authorized share capital of the Company was
US$20,000 divided into 200,000,000 Ordinary Shares of par value of US$0.0001 each. Upon
incorporation of the Company, one subscriber share was allotted and issued at par value to
Mourant Nominees (Cayman) Limited, which was subsequently transferred at par value to
Founder Holdco on February 19, 2020. On the same date, 5,999,999 Ordinary Shares were
allotted and issued at par value to Founder Holdco.
Since our incorporation, we have completed several rounds of pre-IPO financing. See “—
Pre-IPO Investments” below for more information.
HISTORY AND CORPORATE STRUCTURE
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Series Seed Financing
On April 24, 2020, a series seed preferred share purchase agreement was entered into by
and among the Company, DualityBio HK, Dr. ZHU Zhongyuan and the Series Seed Investors,
pursuant to which (i) 2,000,000 Ordinary Shares were issued and allotted to 6D (as defined
below) at par value in consideration of and in recognition of 6D’s provision of backing and
endorsement to Dr. ZHU, who was a partner of 6D, during the early development phase of the
company, and (ii) 5,000,000 Series Seed Preferred Shares were issued and allotted to the Series
Seed Investors (the “ Series Seed Financing ”) for a consideration of US$5,000,000, which was
determined after arm’s length negotiations with reference to our business prospects and the
research and development of our drug candidates at the time of the investment. The total
consideration of US$5,000,200 for the Series Seed Financing was fully settled on May 14,
2020.
Details of the Series Seed Financing are set forth below:
Investors
Number of
Shares Description of Shares Consideration
(US$)
Founder Holdco /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118500,000 Series Seed Preferred
Shares
500,000
6 Dimensions Capital, L.P .
(“6D Capital ”) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
1,900,000 Ordinary Shares 190
1,900,000 Series Seed Preferred
Shares
1,900,000
6 Dimensions Affiliates Fund,
L.P . (“6D Affiliates ”,
together with 6D Capital,
“6D”)/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
100,000 Ordinary Shares 10
100,000 Series Seed Preferred
Shares
100,000
APHN Limited (“ APHN ”) /H1118/H1118/H11181,500,000 Series Seed Preferred
Shares
1,500,000
King Star Med LP
(“King Star Med ”) /H1118/H1118/H1118/H1118/H1118/H1118
1,000,000 Series Seed Preferred
Shares
1,000,000
HISTORY AND CORPORATE STRUCTURE
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Upon completion of the Series Seed Financing, the number of the total issued shares of
the Company was 13,000,000. The shareholding structure of our Company immediately
following completion of the Series Seed Financing is set forth below:
Shareholders
Number of
Shares Description of Shares
Approximately
shareholding
Founder Holdco /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,000,000 Ordinary Shares 46.15%
500,000 Series Seed Preferred
Shares
3.85%
6D Capital /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,900,000 Ordinary Shares 14.62%
1,900,000 Series Seed Preferred
Shares
14.62%
6D Affiliates /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,000 Ordinary Shares 0.77%
100,000 Series Seed Preferred
Shares
0.77%
APHN /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,500,000 Series Seed Preferred
Shares
11.54%
King Star Med /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,000,000 Series Seed Preferred
Shares
7.69%
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111813,000,000 100%
Series A Financing
On July 20, 2020, a series A-1 preferred share purchase agreement was entered into by
and among the Company, DualityBio HK, Duality Suzhou, Duality Shanghai, Dr. ZHU
Zhongyuan, Founder Holdco and the Series A-1 Investors, pursuant to which 12,333,333 Series
A-1 Preferred Shares were issued and allotted to the Series A-1 Investors (the “ Series A-1
Financing ”).
On August 10, 2020, a series A-2 preferred share purchase agreement was entered into by
and among, the Company, DualityBio HK, Duality Suzhou, Duality Shanghai, Dr. ZHU
Zhongyuan, Founder Holdco and WuXi Biologics HealthCare V enture (“ WuXi Venture ”),
pursuant to which 2,666,667 Series A-2 Preferred Shares were issued and allotted to WuXi
V enture at the same purchase price as the Series A-1 Financing (the “ Series A-2 Financing ”,
together with the Series A-1 Financing, the “ Series A Financing ”).
The total consideration for each of the Series A-1 Financing and the Series A-2 Financing
is US$18,500,000 and US$4,000,000, respectively, which was determined after arm’s length
negotiations with reference to our business prospects and the research and development of our
drug candidates at the time of the investment and was fully settled on August 13, 2020 and
August 14, 2020, respectively.
HISTORY AND CORPORATE STRUCTURE
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Details of the Series A Financing are set forth below:
Investors
Number of
Shares Description of Shares Consideration
(US$)
Series A-1 Investors
APHN /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,000,000 Series A-1 Preferred
Shares
1,500,000
GOLDEN SWORD
VENTURES LIMITED
(“Golden Sword ”) /H1118/H1118/H1118/H1118/H1118/H1118/H1118
3,333,333 Series A-1 Preferred
Shares
5,000,000
King Star Med /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,000,000 Series A-1 Preferred
Shares
12,000,000
Series A-2 Investor
WuXi V enture /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,666,667 Series A-2 Preferred
Shares
4,000,000
Upon completion of the Series A Financing, the number of the total issued shares of the
Company was 28,000,000. The shareholding structure of our Company immediately following
completion of the Series A Financing is set forth below:
Shareholders
Number of
Shares Description of Shares
Approximately
shareholding
Founder Holdco /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,000,000 Ordinary Shares 21.43%
500,000 Series Seed Preferred
Shares
1.79%
6D Capital /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,900,000 Ordinary Shares 6.79%
1,900,000 Series Seed Preferred
Shares
6.79%
6D Affiliates /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,000 Ordinary Shares 0.36%
100,000 Series Seed Preferred
Shares
0.36%
APHN /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,500,000 Series Seed Preferred
Shares
5.36%
1,000,000 Series A-1 Preferred
Shares
3.57%
King Star Med /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,000,000 Series Seed Preferred
Shares
3.57%
8,000,000 Series A-1 Preferred
Shares
28.57%
Golden Sword /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,333,333 Series A-1 Preferred
Shares
11.90%
WuXi V enture /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,666,667 Series A-2 Preferred
Shares
9.52%
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111828,000,000 100%
HISTORY AND CORPORATE STRUCTURE
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Series B and Series B+ Financing
Series B Financing
On April 16, 2021, a series B-1 and series B-2 preferred share purchase agreement was
entered into by and among, the Company, DualityBio HK, Duality Suzhou, Duality Shanghai,
Dr. ZHU Zhongyuan, Founder Holdco and the Series B Investors (the “ Series B Investment
Agreement ”), pursuant to which 16,666,666 Series B-1 Preferred Shares and 13,392,857
Series B-2 Preferred Shares were issued and allotted to the Series B Investors (the “ Series B
Financing ”).
The total consideration for the Series B Financing was US$80,000,000, which was
determined after arm’s length negotiations with reference to our business prospects and the
research and development of our drug candidates at the time of the investment. The
consideration for the Series B-1 Preferred Shares and the Series B-2 Preferred Shares was fully
settled on September 22, 2021 and June 10, 2022, respectively.
Series B+ First Tranche Financing
On April 13, 2022, the Company, DualityBio HK, Duality Suzhou, Duality Shanghai, Dr.
ZHU Zhongyuan, Founder Holdco and each of the Series B+ First Tranche Investors entered
into a series B-2 preferred share purchase agreement, pursuant to which a total of 4,185,267
Series B-2 Preferred Shares were issued and allotted to the Series B+ First Tranche Investors
(the “ Series B+ First Tranche Financing ”).
The total consideration for the Series B+ First Tranche Financing was US$12,500,000,
which was determined based on the same purchase price of Series B-2 Preferred Shares as the
Series B Financing. The consideration for the Series B+ First Tranche Financing was fully
settled on April 13, 2023.
Series B+ Second Tranche Financing
On September 19, 2022, the Company, DualityBio HK, Duality Suzhou, Duality
Shanghai, Dr. ZHU Zhongyuan, Founder Holdco and each of the Series B+ Second Tranche
Investors entered into a series B-2 preferred share purchase agreement, pursuant to which a
total of 5,859,374 Series B-2 Preferred Shares were issued and allotted to the Series B+ Second
Tranche Investors (the “ Series B+ Second Tranche Financing ”, together with the Series B+
First Tranche Financing, the “ Series B+ Financing ”, and together with the Series B Financing
and the Series B+ First Tranche Financing, the “ Series B and Series B+ Financing ”).
The total consideration for the Series B+ Second Tranche Financing was US$17,500,000,
which was determined based on the same purchase price of Series B-2 Preferred Shares as the
Series B Financing. The consideration for the Series B+ Second Tranche Financing was fully
settled on March 29, 2023.
HISTORY AND CORPORATE STRUCTURE
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Details of the Series B and Series B+ Financing are set forth below:
Investors
Number of
Shares Description of Shares Consideration
(US$)
Series B Investors
WuXi V enture /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118833,333 Series B-1 Preferred
Shares
2,000,000
669,643 Series B-2 Preferred
Shares
2,000,000
LA V Fund VI, L.P .
(“LA V Fund VI ”) /H1118/H1118/H1118/H1118/H1118/H1118/H1118
6,250,000 Series B-1 Preferred
Shares
15,000,000
5,022,321 Series B-2 Preferred
Shares
15,000,000
Green Pine Growth Fund I
LP (“ Green Pine ”) /H1118/H1118/H1118/H1118/H1118/H1118
1,041,667 Series B-1 Preferred
Shares
2,500,000
837,054 Series B-2 Preferred
Shares
2,500,000
Orchids Limited (“ Orchids ”)/H1118 2,083,333 Series B-1 Preferred
Shares
5,000,000
1,674,107 Series B-2 Preferred
Shares
5,000,000
Shanghai Yingjia Enterprise
Management Partnership
(Limited Partnership) ( ɪऎ
ๅТΆุ၍ଣΥྫΆุ(Ϟ
Υྫ)) (“ Shanghai
Yingjia ”) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
3,541,667 Series B-1 Preferred
Shares
8,500,000
2,845,982 Series B-2 Preferred
Shares
8,500,000
Huagai Sunshine Investment
Fund LP (“ Huagai USD ”) /H1118
583,333 Series B-1 Preferred
Shares
1,400,000
Shenzhen Huagai Qianhai
Kekong Angel V enture
Capital Partnership
(Limited Partnership) ( ଉέ
છ˂Դ௴ุҳ༟
ΥྫΆุ(Υྫ))
(“Shenzhen Huagai ”) /H1118/H1118/H1118/H1118
625,000 Series B-1 Preferred
Shares
1,500,000
Suzhou Huagai Yizhen Equity
Investment Partnership
(Limited Partnership) ( ᘽψ
ᛆҳ༟ΥྫΆุ
(Υྫ)) (“ Suzhou
Huagai ”) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
41,667 Series B-1 Preferred
Shares
100,000
1,674,107 Series B-2 Preferred
Shares
5,000,000
HISTORY AND CORPORATE STRUCTURE
– 257 –


--- page 268 ---
Investors
Number of
Shares Description of Shares Consideration
(US$)
Tianjin Huagai Zeyuan
Equity Investment
Partnership (Limited
Partnership) (ശႊዣჃ
ᛆҳ༟ΥྫΆุ(Υ
ྫ)) (“ Tianjin Huagai ”
together with Shenzhen
Huagai and Suzhou
Huagai, collectively
“Huagai RMB ”) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
833,333 Series B-1 Preferred
Shares
2,000,000
China Singapore Suzhou
Industrial Park V entures
(ʕอᘽψʈุ෤ਜ௴ุҳ
ʮ̡)( “ CSVC ”) /H1118/H1118/H1118
833,333 Series B-1 Preferred
Shares
2,000,000
669,643 Series B-2 Preferred
Shares
2,000,000
Series B+ First Tranche
Investors
SW BIOTECH I LPF ( ɖ᳅ᔼ
ږ)
“(SW Biotech ”) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
1,674,107 Series B-2 Preferred
Shares
5,000,000
CSVC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,004,464 Series B-2 Preferred
Shares
3,000,000
Suzhou Taikuntong Start-up
Investments Partnership
(Limited Partnership) ( ᘽψ
इ㆕ஷ௴ุҳ༟ΥྫΆุ
(Υྫ)) (“ Tai Kun ”) /H1118/H1118
1,506,696 Series B-2 Preferred
Shares
4,500,000
Series B+ Second Tranche
Investors
Hangzhou AstraZeneca CICC
venture capital partnership
(L.P .) (௴
ุҳ༟ΥྫΆุ(Υྫ))
(“AZ-CICC Fund I ”) /H1118/H1118/H1118/H1118
1,674,107 Series B-2 Preferred
Shares
5,000,000
Wuxi AstraZeneca CICC
No. 1 V enture Capital
Partnership (L.P .) (ڛ
ఠ໮௴ุҳ༟Υ
ྫΆุ(Υྫ)) (“ AZ-
CICC Fund II ”, together
with AZ-CICC Fund I,
“AZ-CICC Fund ”) /H1118/H1118/H1118/H1118/H1118/H1118
1,674,107 Series B-2 Preferred
Shares
5,000,000
HISTORY AND CORPORATE STRUCTURE
– 258 –


--- page 269 ---
Investors
Number of
Shares Description of Shares Consideration
(US$)
Xiamen Shenglianzhiyuan
Equity Investment Limited
Partnership (ߧ
ᛆҳ༟ΥྫΆุ(ࠢ
Υྫ)) (“ Shenglian ”) /H1118/H1118/H1118/H1118/H1118
1,506,696 Series B-2 Preferred
Shares
4,500,000
Tasly International
Capital Limited
(ʮ̡)
(“Tasly International
Capital ”)
(Note) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
1,004,464 Series B-2 Preferred
Shares
3,000,000
Note: On June 26, 2023, Tasly International Capital transferred all of its Shares (the “ Tasly Shares ”) in the
Company to Y ue Cheng International Capital Limited (“ Yue Cheng Capital ”) pursuant to a share
purchase agreement entered into between Tasly International Capital and Y ue Cheng Capital (the “ Share
Purchase Agreement ”). Following further commercial discussions between the parties, the Share
Purchase Agreement was terminated on June 29, 2024. Subsequently, the Tasly Shares were transferred
back to Tasly International Capital and Tasly International Capital restored its shareholding in the
Company on June 30, 2024.
As transitional arrangements before the completion of the ODI registration of certain
investors on the same date of RMB CB Investors’ (as defined below) respective share purchase
agreements, (i) each of Orchids, Huagai RMB, CSVC, Tau Kun, and AZ-CICC Fund
(collectively, the “ RMB CB Investors ”) and their respective affiliates entered into a
convertible loan agreement with Duality Suzhou, the Company, Duality Shanghai, and
DualityBio HK, pursuant to which (a) the respective offshore affiliates of each RMB CB
Investor agreed to provide convertible loans to Duality Suzhou in a total principal amount
equal to the consideration for the respective purchase of the Series B-1 Preferred Shares and/or
the Series B-2 Preferred Shares by the RMB CB Investors (the “ Convertible Loans ”); and (b)
Duality Suzhou agreed to repay the Convertible Loans upon receipt of notification from each
RMB CB Investor of the completion of its ODI registration for its respective purchase; and (ii)
each of Shanghai Yingjia and Shenglian (collectively, the “ RMB Advance Investors ”) and
their respective affiliates entered into an advance payment agreement with Duality Suzhou, the
Company, Duality Shanghai, and DualityBio HK, pursuant to which (a) the respective offshore
affiliates of each RMB Advance Investor agreed to make advance payments to Duality Suzhou
in a total principal amount equal to the consideration for their purchase of the Series B-2
Preferred Shares (the “ Advance Payments ”); and (b) Duality Suzhou agreed to repay the
Advance Payments upon receipt of notification from each RMB Advance Investor of the
completion of its ODI registration for its respective purchase. As of the Latest Practicable Date,
all Convertible Loans and Advance Payments have been fully repaid.
HISTORY AND CORPORATE STRUCTURE
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Upon completion of the Series B and Series B+ Financing, the number of the total issued
shares of the Company was 68,104,164. The shareholding structure of our Company
immediately following completion of the Series B and Series B+ Financing is set forth below:
Shareholders
Number of
Shares Description of Shares
Approximately
shareholding
Founder Holdco /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,000,000 Ordinary Shares 8.81%
500,000 Series Seed Preferred
Shares
0.73%
6D Capital /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,900,000 Ordinary Shares 2.79%
1,900,000 Series Seed Preferred
Shares
2.79%
6D Affiliates /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,000 Ordinary Shares 0.15%
100,000 Series Seed Preferred
Shares
0.15%
APHN /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,500,000 Series Seed Preferred
Shares
2.20%
1,000,000 Series A-1 Preferred
Shares
1.47%
King Star Med /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,000,000 Series Seed Preferred
Shares
1.47%
8,000,000 Series A-1 Preferred
Shares
11.75%
Golden Sword /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,333,333 Series A-1 Preferred
Shares
4.89%
WuXi V enture /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,666,667 Series A-2 Preferred
Shares
3.92%
833,333 Series B-1 Preferred
Shares
1.22%
669,643 Series B-2 Preferred
Shares
0.98%
LA V Fund VI /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,250,000 Series B-1 Preferred
Shares
9.18%
5,022,321 Series B-2 Preferred
Shares
7.37%
Green Pine /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,041,667 Series B-1 Preferred
Shares
1.53%
837,054 Series B-2 Preferred
Shares
1.23%
Orchids /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,083,333 Series B-1 Preferred
Shares
3.06%
1,674,107 Series B-2 Preferred
Shares
2.46%
HISTORY AND CORPORATE STRUCTURE
– 260 –


--- page 271 ---
Shareholders
Number of
Shares Description of Shares
Approximately
shareholding
Shanghai Yingjia /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,541,667 Series B-1 Preferred
Shares
5.20%
2,845,982 Series B-2 Preferred
Shares
4.18%
Huagai USD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118583,333 Series B-1 Preferred
Shares
0.86%
Shenzhen Huagai /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118625,000 Series B-1 Preferred
Shares
0.92%
Suzhou Huagai /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111841,667 Series B-1 Preferred
Shares
0.06%
1,674,107 Series B-2 Preferred
Shares
2.46%
Tianjin Huagai /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118833,333 Series B-1 Preferred
Shares
1.22%
CSVC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118833,333 Series B-1 Preferred
Shares
1.22%
1,674,107 Series B-2 Preferred
Shares
2.46%
SW Biotech /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,674,107 Series B-2 Preferred
Shares
2.46%
Tai Kun /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,506,696 Series B-2 Preferred
Shares
2.21%
AZ-CICC Fund I /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,674,107 Series B-2 Preferred
Shares
2.46%
AZ-CICC Fund II /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,674,107 Series B-2 Preferred
Shares
2.46%
Shenglian /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,506,696 Series B-2 Preferred
Shares
2.21%
Tasly International Capital /H1118/H1118/H11181,004,464 Series B-2 Preferred
Shares
1.47%
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111868,104,164 100%
Share Transfer from 6D and APHN to LAV USD
On October 15, 2024, LA V Fund VI Opportunities, L.P . (“ LA V Opportunities ”, together
with LA V Fund VI, “ LA V USD”) entered into instruments of transfer with each of APHN, 6D
Capital and 6D Affiliates, pursuant to which (i) APHN transferred 1,000,000 Series A-1
Preferred Shares to LA V Opportunities for a consideration of US$3,584,000; (ii) 6D Capital
transferred 1,900,000 Ordinary Shares and 1,900,000 Series Seed Preferred Shares to LA V
Opportunities for an aggregate consideration of US$13,619,200; and (iii) 6D Affiliates
transferred 100,000 Ordinary Shares and 100,000 Series Seed Preferred Shares to LA V
Opportunities for a consideration of US$716,800 (collectively, the “ Share Transfer to LA V
HISTORY AND CORPORATE STRUCTURE
– 261 –


--- page 272 ---
USD”). The considerations for the Share Transfer to LA V USD were determined through arm’s
length negotiations between the transferors and transferee, taking into account our business
prospects, research and development progress of our drug candidates, and the commercial
considerations of the relevant parties at the time of the transfer. The relevant considerations
were fully settled on December 6, 2024. Upon completion of the Share Transfer to LA V USD,
(i) LA V Opportunities held 2,000,000 Ordinary Shares, 2,000,000 Series Seed Preferred Shares
and 1,000,000 Series A-1 Preferred Shares; (ii) APHN held 1,500,000 Series Seed Preferred
Shares; and (iii) 6D ceased to be a Shareholder of the Company.
Share Transfer from King Star Med to Hoi Pok
On November 21, 2024, Hoi Pok (Hong Kong) Trading Company (“ Hoi Pok ”) entered
into an instrument of transfer with King Star Med, pursuant to which King Star Med transferred
1,205,223 Series A-1 Preferred Shares to Hoi Pok for a consideration of US$6,000,000 (the
“Share Transfer to Hoi Pok ”). The consideration for the Share Transfer to Hoi Pok was
determined through arm’s length negotiations between the transferor and transferee, taking into
account our business prospects, research and development progress of our drug candidates, and
the commercial considerations of the relevant parties at the time of the transfer. The
consideration was fully settled on November 27, 2024. Upon completion of the Share Transfer
to Hoi Pok, (i) Hoi Pok held 1,205,223 Series A-1 Preferred Shares; and (ii) King Star Med
held 1,000,000 Series Seed Preferred Shares and 6,794,777 Series A-1 Preferred Shares.
Share Transfer from King Star Med to Hankang
On December 12, 2024, each of Hankang Biotech Fund III, L.P . and Splendid Biotech
Fund L.P . (collectively, “ Hankang ”) entered into an instrument of transfer with King Star Med,
pursuant to which (i) King Star Med transferred 803,482 Series A-1 Preferred Shares to
Hankang Biotech Fund III, L.P . for a consideration of US$4,000,000; and (ii) King Star Med
transferred 401,741 Series A-1 Preferred Shares to Splendid Biotech Fund L.P . for a
consideration of US$2,000,000 (collectively, the “ Share Transfer to Hankang ”). The
considerations for the Share Transfer to Hankang were determined through arm’s length
negotiations between the transferor and transferees, taking into account our business prospects,
research and development progress of our drug candidates, and the commercial considerations
of the relevant parties at the time of the transfer. The relevant considerations were fully settled
on December 13, 2024. Upon completion of the Share Transfer to Hankang, (i) Hankang
Biotech Fund III, L.P . held 803,482 Series A-1 Preferred Shares; (ii) Splendid Biotech Fund
L.P . held 401,741 Series A-1 Preferred Shares; and (iii) King Star Med held 1,000,000 Series
Seed Preferred Shares and 5,589,554 Series A-1 Preferred Shares.
HISTORY AND CORPORATE STRUCTURE
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VOTING RIGHTS PROXY AGREEMENT
In order to maintain an appropriate balance of voting influence between the Company’s
single largest shareholder (i.e., LA V USD) and its founder (i.e., Dr. ZHU Zhongyuan) during
the Company’s private company phase following completion of the Share Transfer to LA V
USD, on October 15, 2024, LA V Opportunities and Founder Holdco entered into a voting rights
proxy agreement (the “ Voting Rights Proxy Agreement ”), pursuant to which LA V
Opportunities irrevocably and unconditionally appointed Founder Holdco as its true and lawful
attorney and proxy with respect to the exercise of voting rights of the 2,000,000 Ordinary
Shares (representing approximately 2.94% of our Company’s total issued Shares as of the
Latest Practicable Date) held by LA V Opportunities (the “ Subject Shares ”) in connection with
all matters upon which the Subject Shares are entitled to vote. The V oting Rights Proxy
Agreement shall effect from October 15, 2024 through the earlier of (a) the completion of the
Global Offering or any deemed liquidation event as prescribed under the seventh amended and
restated articles of association of our Company, and (b) the date when LA V Opportunities no
longer holds any Subject Shares and such Subject Shares have been transferred to any third
party by LA V Opportunities (other than any affiliate of LA V Opportunities).
Upon the Listing, the V oting Rights Proxy Agreement will automatically terminate. The
Company believes such arrangement can foster clarity and transparency within the Company’s
governance structure during its transition from a private company to a publicly listed company
as:
(a) it ensures that the Company will have a straightforward and transparent
shareholding structure post-Listing, enabling public investors to easily comprehend
the voting dynamics among the Company’s shareholders by simply examining the
shareholding structure table, which eliminates the necessity to refer to additional
arrangements such as a voting proxy arrangement; and
(b) it aligns with the prevailing market practices and general corporate governance
expectation for listed companies where the institutional investors typically maintain
direct control over their voting rights, and various mechanisms exist to balance
stakeholder interests.
HISTORY AND CORPORATE STRUCTURE
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--- page 274 ---
PRE-IPO INVESTMENTS
Principal Terms of the Pre-IPO Investments
Our Company concluded several rounds of investments with the Pre-IPO Investors. The
basis of determination for the consideration of the Pre-IPO Investments were from arm’s length
negotiations after taking into consideration the timing of the investments and the status of our
business operation and product development between (i) our Company and the Pre-IPO
Investors in respect of the equity financings, and (ii) the relevant transferors and transferees in
respect of the share transfers. The following tables summarize the key terms of the Pre-IPO
Investments to our Company made by the Pre-IPO Investors:
Equity Financings of the Company
Series Seed
Financing Series A Financing Series B Financing
Series B+
Financing
Date of agreement(s) /H1118/H1118/H1118April 24, 2020 July 20, 2020 and
August 10, 2020
April 16, 2021 April 13, 2022 and
September 19,
2022
Date of payment of
full consideration /H1118/H1118/H1118/H1118
May 14, 2020 August 13, 2020 and
August 14, 2020
September 22, 2021
and June 10, 2022
April 13, 2023 and
March 29, 2023
Approximate cost per
Share (US$) /H1118/H1118/H1118/H1118/H1118/H1118/H1118
US$0.0001 per
Ordinary Shares;
US$1.00 per
Series Seed
Preferred Shares
US$1.50 per Series
A-1 Preferred
Shares; US$1.50
per Series A-2
Preferred Shares
US$2.40 per Series
B-1 Preferred
Shares; US$2.9867
per Series B-2
Preferred Shares
US$2.9867 per Series
B-2 Preferred
Shares
Amount of Shares
subscribed /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
2,000,000 Ordinary
Shares; 5,000,000
Series Seed
Preferred Shares
12,333,333 Series
A-1 Preferred
Shares; 2,666,667
Series A-2
Preferred Shares
16,666,666 Series
B-1 Preferred
Shares; 13,392,857
Series B-2
Preferred Shares
10,044,641 Series
B-2 Preferred
Shares
Amount of consideration
paid for Shares
subscription /H1118/H1118/H1118/H1118/H1118/H1118/H1118
US$200 for Ordinary
Shares; US$5.0
million for Series
Seed Shares
US$18.5 million for
Series A-1
Preferred Shares;
US$4.0 million for
Series A-2
Preferred Shares
US$40.0 million for
Series B-1
Preferred Shares;
US$40.0 million
for Series B-2
Preferred Shares
US$30.0 million
HISTORY AND CORPORATE STRUCTURE
– 264 –


--- page 275 ---
Series Seed
Financing Series A Financing Series B Financing
Series B+
Financing
Discount to the Offer
Price (1) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
100.00% for per
Ordinary Share
and 92.14% for
per Series Seed
Preferred Share
88.21% for per Series
A-1 Preferred
Share and per
Series A-2
Preferred Share
81.13% for per Series
B-1 Preferred
Share and 76.52%
for Series B-2
Preferred Shares
76.52% for Series
B-2 Preferred
Shares
Post-money valuation of
our Company
(undiluted)
(2) /H1118/H1118/H1118/H1118/H1118/H1118
US$13.00 million US$42.00
million (3)
US$173.41
million (4)
US$203.41
million (5)(6)
Post-money valuation of
our Company (fully
diluted)
(2) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
US$14.50 million US$56.25 million US$208.52 million US$269.97 million
Use of proceeds /H1118/H1118/H1118/H1118/H1118/H1118We utilized the proceeds to finance our ADC platform development activities, R&D activities
of pipeline products, as well as to support the working capital needs of our Group. As of the
Latest Practicable Date, all the net proceeds from the Pre-IPO Investments had been utilized
for the aforementioned purposes.
Lock-up period /H1118/H1118/H1118/H1118/H1118/H1118Pursuant to the lock-up undertakings given by the Pre-IPO Investors to the Joint Sponsors, each
Pre-IPO Investor, subject to the terms of such lock-up undertakings, will not, whether
directly or indirectly, at any time during the period agreed by such Pre-IPO Investor and the
Joint Sponsors dispose of any of the Shares held by such Pre-IPO Investor.
Strategic benefits /H1118/H1118/H1118/H1118/H1118Our Group would benefit from the additional capital injected by the Pre-IPO Investors in our
Group, their business resources, knowledge and experience, potential business opportunities
and benefits that may be provided by them. Our Pre-IPO Investors include private equity
funds and other professional investment companies, many of which are highly experienced
in investing in the healthcare and biopharmaceutical industry. Our Directors believed that
our Company could benefit from their industry insights and guidance. Our Directors were
also of the view that the Pre-IPO Investments demonstrate the Pre-IPO Investors’
commitment and confidence in the business performance and operations, strengths and
long-term prospects of our Group.
Notes:
(1) The discount to the Offer Price is calculated based on the foreign exchange rate as of the Latest Practicable
Date and the assumption that the Offer Price is HK$98.90 per Share (being the mid-point of the indicative
Offer Price range).
HISTORY AND CORPORATE STRUCTURE
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--- page 276 ---
(2) Post-money valuation (undiluted) is calculated as (a) cost per Share multiplied by (b) total number of Shares
in issue upon completion of the relevant Pre-IPO Investment round. Post-money valuation (fully diluted) is
calculated in accordance with the relevant shareholders agreement as (a) cost per Share multiplied by (b) total
number of (i) Shares in issue and (ii) Shares to be issued pursuant to the Pre-IPO Equity Incentive Plan (on
a fully-diluted and as-exercised basis), upon completion of the relevant Pre-IPO Investment round. The
valuation of our Company was determined based on, among other things, arm’s length negotiations between
the relevant parties primarily taking into consideration the status and continuous development of our business
and the progress in the R&D of our pipeline.
(3) The increase of our Company’s valuation during the period between the Series Seed Financing and the Series
A Financing reflects the investors’ recognition of our initial blueprint for the next generation of ADC products.
This growth is supported by key achievements on our DITAC platform, through which we successfully
identified suitable linker payload molecules and conducted preliminary IP free-to-operate analyses, ensuring
unrestricted implementation of our technology. Furthermore, we validated the anti-tumor activity of molecules
in early preclinical models for DB-1303, both in vivo and in vitro, leading to the significant milestone of
designating a preclinical candidate.
(4) The increase of our Company’s valuation during the period between the Series A Financing and the Series B
Financing is primarily due to the preliminary preclinical validation on the DITAC platform, and the related
patent applications having been filed for priority. Specifically, DB-1303 advanced to the IND-enabling stage,
demonstrating a better tolerable dose in monkey toxicity studies compared to other products. Additionally,
DB-1305 achieved preclinical candidate designation and also entered the IND-enabling stage, demonstrating
superior anti-tumor activity in multiple preclinical models relative to benchmark products. Furthermore, our
autoimmune platform DIMAC made significant progress, identifying suitable linker payloads and initiating the
development of DB-2304, an innovative ADC candidate targeting autoimmune diseases.
(5) The increase of our Company’s valuation during the period between the Series B Financing and the Series B+
Financing is primarily due to (i) the establishment of our senior management team, (ii) the filing and approval
of an IND application for DB-1303, marking its crucial transition from preclinical research to clinical
development, (iii) our other products, including DB-1310, DB-1311, DB-1312 and DB-2304, obtaining
preclinical candidate molecules, and (iv) early research results on our DIBAC platform. The purchase price of
Series B-2 Preferred Shares remained unchanged between the Series B Financing and the Series B+ Financing,
because the share purchase agreements for the Series B+ Financing were entered into around the time of the
closing of the Series B Financing for the Series B-2 Preferred Shares.
(6) The increase of our Company’s valuation upon Listing from Series B+ Financing is primarily due to the R&D
progress we made in our drug candidates and platforms, alongside achieving key business milestones
subsequent to Series B+ financing including, among others, (i) the R&D progress of our Core Product -
DB-1303: initiating a global potential registrational study in HER2-expressing endometrial cancer (EC) and
a phase 3 global registrational trial in chemo-naïve HR+/HER2-low metastatic BC and receiving Breakthrough
Therapy Designations from both the FDA and the NMPA for certain indications; (ii) the R&D progress of our
Core Product-DB-1311: receiving Fast Track Designation from the FDA; (iii) the R&D progress of our key
products - DB-1305: receiving Fast Track Designation from the FDA; (iv) the R&D progress of our key
products - DB-1419: receiving IND approval; and (v) entering into global partnerships with several world-class
pharmaceutical companies with a total deal value of over US$5.0 billion, including a collaboration with
BioNTech on DB-1303, DB-1311 and DB-1305 and a collaboration with GSK on DB-1324.
HISTORY AND CORPORATE STRUCTURE
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--- page 277 ---
Transfers of Existing Shares
Share Transfer
to LA V USD
Share Transfer
to Hoi Pok
Share Transfer
to Hankang
Date of agreement(s) /H1118/H1118/H1118/H1118October 15, 2024 November 21, 2024 December 12, 2024
Date of payment of full
consideration /H1118/H1118/H1118/H1118/H1118/H1118/H1118
December 6, 2024 November 27, 2024 December 13, 2024
Approximate cost
per Share (US$) (1) /H1118/H1118/H1118/H1118
US$3.584 per Ordinary
Share; US$3.584 per
Series Seed Preferred
Shares; US$3.584 per
Series A-1 Preferred
Share
US$4.978 per Series A-1
Preferred Share
US$4.978 per Series A-1
Preferred Share
Amount of Shares
transferred /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
2,000,000 Ordinary Shares;
2,000,000 Series Seed
Preferred Shares;
1,000,000 Series A-1
Preferred Shares
1,205,223 Series A-1
Preferred Shares
1,205,223 Series A-1
Preferred Shares
Amount of consideration
paid for Shares
transfers /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
US$17,920,000 US$6,000,000 US$6,000,000
Discount to the
Offer Price
(2) /H1118/H1118/H1118/H1118/H1118/H1118/H1118
71.82% 60.86% 60.86%
Lock-up period /H1118/H1118/H1118/H1118/H1118/H1118/H1118Pursuant to the lock-up undertakings given by LA V USD, Hoi Pok and Hankang to the Joint
Sponsors, each of them, subject to the terms of such lock-up undertakings, will not,
whether directly or indirectly, at any time during the period agreed by it and the Joint
Sponsors dispose of any of the Shares held by it.
Notes:
(1) The transfer price was independently negotiated between the relevant transferor and transferee, both of which
are professional investors.
(2) The discount to the Offer Price is calculated based on the foreign exchange rate as of the Latest Practicable
Date and the assumption that the Offer Price is HK$98.90 per Share (being the mid-point of the indicative
Offer Price range).
HISTORY AND CORPORATE STRUCTURE
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--- page 278 ---
Information regarding the Pre-IPO Investors
Our Pre-IPO Investors include certain Sophisticated Investors, such as King Star Med,
Shanghai Yingjia, Orchids and Golden Sword. Each Sophisticated Investor has made
meaningful investment in the Company at least six months before the Listing Date, holding
approximately 7.92%, 7.68%, 4.52% and 4.01% of the total issued Shares immediately
following the completion of the Global Offering, assuming the Offer Size Adjustment Option
and the Over-allotment Option are not exercised, respectively. Upon Listing, LA V USD and
Founder Holdco will be connected persons of the Company as (i) LA V USD will be a
substantial shareholder of the Company, and (ii) Founder Holdco is wholly owned by Dr. ZHU
Zhongyuan, who is a Director and chief executive officer of the Company. To the best of the
Company’s knowledge, information and belief having made all reasonable enquiries, all other
Pre-IPO Investors are Independent Third Parties. The background information of the Pre-IPO
Investors is set out below.
Pre-IPO Investors Background
King Star Med /H1118/H1118/H1118/H1118/H1118King Star Med is an investment fund organized under the laws of
the Cayman Islands, specializing in investments with a primary
focus on healthcare and biotech with a fund size of approximately
US$100 million. The general partner and manager of King Star
Med, namely King Star Med Management Limited and King Star
Consulting Limited, are both indirectly held by Ace Treasure
Trust and Superb Outcome Trust (the “ Trusts ”) as to 40.0% and
30.0%, respectively. Dr. LIN Xianghong is the settlor, the
protector and one of the beneficiaries of the Trusts. The voting
and investment power of shares held by King Star Med is
exercised by the two directors, Dr. LIN Xianghong and Ms. YU
Bin, of King Star Med Management Limited, no one of whom
may act alone to vote or dispose of the shares. No limited partner
holds more than 30% economic interests in King Star Med. The
management team of King Star Med has been specializing in
private equity and venture capital investment, and accumulated
experience in financing for the development of biotech
companies. The portfolio of King Star Med in biotech or
healthcare sectors includes Gracell Biotechnologies, a company
previously listed on the Nasdaq (stock code: GRCL) and acquired
by AstraZeneca PLC, a company listed the Nasdaq and London
Stock Exchange (symbol: AZN) in 2023, Adagene Inc., a
company listed on the Nasdaq (stock code: ADAG), CStone
Pharmaceuticals, a company listed on the Stock Exchange (stock
code: 2616), JW (Cayman) Therapeutics Co. Ltd, a company
listed on the Stock Exchange (stock code: 2126).
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Pre-IPO Investors Background
Shanghai Yingjia /H1118/H1118/H1118Shanghai Yingjia is a limited partnership incorporated in
the PRC. Shanghai Yingjia is held as to 0.01% by Xiamen
Yinglian Health Industry Management Partnership
(Limited Partnership) (ๅᑌ਄ੰପุ၍ଣΥྫΆุ(Υ
ྫ)) (“ Yinglian Management ”), its general partner. The
remaining 99.99% interest in Shanghai Yingjia is held by its
limited partner, Xiamen Yinglian Health Industry Investment
Partnership (Limited Partnership) (ๅᑌ਄ੰପุҳ༟ΥྫΆ
ุ(Υྫ)) (“ Yinglian Investment ”). Each of Yinglian
Management and Yinglian Investment is controlled by Xiamen
Yinglian Health Industry Investment Management Co. Ltd. (ژ
ʮ̡)( “Xiamen Yinglian ”), which is
ultimate beneficially owned by LUO Jing, an Independent Third
Party. As of the Latest Practicable Date, Xiamen Yinglian had
assets under management of over US$200 million. Its investment
portfolio includes, among others, Hinova Pharmaceuticals Inc.
(ʮ̡), a company listed on Shanghai Stock
Exchange (stock code: 688302), BioNova Pharmaceuticals ( ⮶ሾ
ᔼᖹ), Full-Life Technologies (Ҧ), Y olTech (Shanghai)
Therapeutics Co., Ltd. (ࡥ(ɪऎ)ʮ̡
, Innovac
Therapeutics (Ҧ), and Reistone Biopharma ( ๿
ͩᔼᖹ).
Orchids /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Orchids is a limited liability company established under the laws
of BVI. Orchids is a subsidiary of Shanghai Lihao Biotech, L.P .
(ҦΥྫΆุ(Υྫ)) (“ Shanghai Lihao ”),
which is a limited partnership established under the laws of the
PRC. The general partner of Shanghai Lihao is Shanghai Liyi
Investment Management Partnership (Limited Partnership) ( ɪऎ
ᓿ᎚ҳ༟၍ଣΥྫΆุ(Υྫ)) (“ Liyi Investment I ”). The
general partner of Liyi Investment I is Shanghai Liyao
Investment Management Co., Ltd. (ʮ̡)
(“Shanghai Liyao ”), which is in turn wholly owned by
Dr. CHEN Fei, an Independent Third Party.
The sole limited partner of Shanghai Lihao is Suzhou Likang
Equity Investment Centre (LP) (ᛆҳ༟ʕː(Υ
ྫ)( “ Suzhou Likang ”). The general partner of Suzhou Likang is
Shanghai Liyi Investment Management Partnership (Limited
Partnership) ( ɪऎᓿ൪ҳ༟၍ଣΥྫΆุ(Υྫ)) (“ Liyi
Investment II ”). No limited partner of Suzhou Likang holds
more than 30% interests. The general partner of Liyi Investment
II is Shanghai Liyao.
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Pre-IPO Investors Background
As of the Latest Practicable Date, Liyi Investment I, Liyi
Investment II, and their respective affiliates, all controlled by Dr.
CHEN Fei (together, “ Liyi Investment Group ”), had assets
under management of approximately US$1.7 billion. Liyi
Investment Group dedicated its investments primarily to
healthcare and biotech companies including Sichuan Kelun-
Biotech Biopharmaceutical Co., Ltd. (ٰ
ʮ̡), a company listed on the Stock Exchange (stock
code: 6990), and Terns Pharmaceuticals, Inc., a company listed
on the NASDAQ (ticker : TERN).
As confirmed by LA V USD, which is ultimately controlled by Dr.
SHI Yi, and Orchids, which is ultimately controlled by Dr. CHEN
Fei, each of LA V USD and Orchids makes its investment
decisions independently and there is no concert party
arrangement or voting arrangement between them with respect to
their interests in the Company.
Golden Sword /H1118/H1118/H1118/H1118/H1118Golden Sword is an investment holding wholly owned by Sino
Biopharmaceutical Limited, a limited liability company
incorporated in the Cayman Islands and was listed on the Stock
Exchange (stock code: 1177) in 2003 and became a constituent
stock of the Hang Seng Index in 2018. Sino Biopharmaceutical
Limited principally engages in the research and development as
well as the manufacture and sales of pharmaceutical products. Its
products have gained a competitive foothold in various
therapeutic categories with promising potentials, comprising a
variety of biopharmaceutical and chemical medicines for tumors,
surgery/analgesia, liver diseases, respiratory system diseases and
others. Sino Biopharmaceutical Limited is an Independent Third
Party.
HISTORY AND CORPORATE STRUCTURE
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Pre-IPO Investors Background
LA V USD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118LA V Fund VI is a Cayman Islands exempted limited partnership
and none of the limited partners of LA V Fund VI holds more than
30% interest. The general partner of LA V Fund VI is LA V GP VI,
L.P . The general partner of LA V GP VI, L.P . is LA V Corporate VI
GP , Ltd.
LA V Opportunities is a Cayman Islands exempted limited
partnership and none of the limited partners in LA V Opportunities
holds more than 30% interest. The general partner of LA V
Opportunities is LA V GP VI Opportunities, L.P . The general
partner of LA V GP VI Opportunities, L.P . is LA V Corporate VI
GP Opportunities, Ltd.
Each of LA V Corporate VI GP , Ltd. and LA V Corporate VI GP
Opportunities, Ltd. is a Cayman Islands exempted company
wholly owned by Dr. SHI Yi. LA V USD is within a group of
offshore investment vehicles, the investments of which are
denominated in U.S. dollar, controlled by Dr. SHI Yi (“ LA V USD
Group ”). As of the Latest Practicable Date, LA V USD Group had
assets under management of approximately US$3.5 billion and
invested in over one hundred portfolios covering all major sectors
of the biomedical and healthcare industry including
biopharmaceuticals, medical devices, diagnostics and healthcare
services, examples including ArriV ent BioPharma, Inc., a
company listed on the NASDAQ (symbol: A VBP), Abbisko
Cayman Limited, a company listed on the Stock Exchange (stock
code: 2256) and Jacobio Pharmaceuticals Group Co., Ltd., a
company listed on the Stock Exchange (stock code: 1167).
APHN /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118APHN is a company with limited liability incorporated under the
laws of the BVI and is ultimately owned by the personal
representative of the estate of the late Dr. ZHAO Ning, Dr. LI Ge,
an Independent Third Party. APHN’s principal business is
investment. As of the Latest Practicable Date, APHN’s
investment portfolio consists solely of its investment in the
Company.
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Pre-IPO Investors Background
WuXi V enture /H1118/H1118/H1118/H1118/H1118WuXi V enture is a limited liability partnership incorporated in
Hong Kong which is principally engaged in investment activities.
WuXi V enture is wholly owned and ultimately controlled by
WuXi Biologics (Cayman) Inc., a company listed on the Stock
Exchange (stock code: 2269) and is a global biologics contract
research, development and manufacturing organization offering
end-to-end solutions that enable partners to discover, develop and
manufacture biologics from concept to commercialization for the
benefit of patients worldwide. WuXi Biologics (Cayman) Inc. is
an Independent Third Party, who invested, among others, I-Mab
(ʮ̡), a company listed on the Nasdaq
(ticker: IMAB) and Zenas BioPharma, a company listed on the
Nasdaq (ticker: ZBIO).
Green Pine /H1118/H1118/H1118/H1118/H1118/H1118/H1118Green Pine is an exempted limited partnership incorporated under
the laws of the Cayman Islands, with its general partner being
Green Pine International Capital Partners (“ GPCP ”) which is
ultimately owned by LUO Fei (࠭and LI Wei ( ᄒਃ). GPCP
principally invests in artificial intelligence, healthcare and new
material industries. The limited partners of Green Pine are (i)
Lilac International Investment Company Limited which is
interested in 26.53% of its equity interests; (ii) Mizuho Bank, Ltd
which is interested in 13.53% of its equity interests; (iii) Bondwa
Enterprise Limited which is interested in 10.61% of its equity
interests; (iv) JU Xiongwei who is interested in 10.61% of its
equity interests; (v) Avant Sports Industrial Co., Limited which is
interested in 5.31% of its equity interests; (vi) Sidereal Group
Limited which is interested in 6.37% of its equity interests; (vii)
KA V Invest Holding AG which is interested in 3.71% of its equity
interests; and (viii) five individuals each of whom is interested in
no more than 10% of its equity interests. Each of Green Pine,
GPCP , LUO Fei and LI Wei and the aforesaid limited partners is
an Independent Third Party.
As of the Latest Practicable Date, Green Pine had assets under
management of approximately US$18.9 million. Its investment
portfolio includes, among others, HighTide Therapeutics, Inc., a
company listed on the Stock Exchange (stock code: 2511),
Analytical Biosciences Ltd., and Huahui Healthcare, Inc.
HISTORY AND CORPORATE STRUCTURE
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Pre-IPO Investors Background
Huagai RMB /H1118/H1118/H1118/H1118/H1118/H1118Suzhou Huagai is a limited partnership incorporated in the PRC,
whose general partner is Huagai Shangzhen Medical Investment
Management (Suzhou) Co., Ltd. (ጲᔼᐕҳ༟၍ଣ(ᘽψ)
ʮ̡), which is controlled by Huagai Capital Co., Ltd. ( ശႊ
ப΂ʮ̡)( “ Huagai Capital ”). No limited partner of
Suzhou Huagai holds more than 30% economic interests.
Shenzhen Huagai is a limited partnership incorporated in the
PRC, whose general partner is HuaGai Southern Investment
Management (Shenzhen) Co., Ltd. (˙ҳ༟၍ଣ(ଉέ)ࠢ
ʮ̡), which is controlled by Huagai Capital. One limited partner
of Shenzhen Huagai, namely Shenzhen Angel Investment
Guidance Fund Co., Ltd. (ʮ̡),
holds 40% economic interests in Shenzhen Huagai, which is
ultimately controlled by Finance Bureau of Shenzhen
Municipality (҅), an Independent Third Party. Other
than that, no limited partner of Shenzhen Huagai holds more than
30% economic interests.
Tianjin Huagai is a limited partnership incorporated in the PRC,
whose general partner is Beijing HuaGai Healthcare Investment
Management Co., Ltd. ( ശႊᔼᐕҳ༟၍ଣ(̏ԯ)ʮ̡),
which is controlled by Huagai Capital. One limited partner of
Tianjin Huagai, namely, Semir Group Co., Ltd. (ʮ
̡), holds approximately 85% economic interests in Tianjin
Huagai, which is owned as to 40% and 30% by QIU Guanghe (ړ
Έձ) and ZHENG Qiulan (ᚆ), respectively, each an
Independent Third Party. Other than that, no limited partner of
Tianjin Huagai holds more than 30% economic interests.
Huagai Capital is a company established in the PRC with assets
under management of approximately RMB20 billion as of June
30, 2024, and is held as to 30% and controlled by Liaoning
Chengda Co., Ltd. (ʮ̡), a company listed on
the Shanghai Stock Exchange (stock code: 600739), an
Independent Third Party which has invested in several healthcare
and biotech companies, including Shenzhen Kangtai Biological
Products Co., Ltd. (ʮ̡), a company
listed on the Shenzhen Stock Exchange (stock code: 300601),
Hygeia Healthcare Holding Co., Ltd. (ʮ̡),
a company listed on the Stock Exchange (stock code: 6078) and
Shanghai Micurx Pharmaceutical Co., Ltd. (΅Ϟ
ʮ̡),a company listed on the Shanghai Stock Exchange (stock
code: 688373).
HISTORY AND CORPORATE STRUCTURE
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Pre-IPO Investors Background
Huagai USD /H1118/H1118/H1118/H1118/H1118/H1118Huagai USD is an exempted limited partnership registered in the
Cayman Islands. The limited partners of Huagai USD are Sunet
Global Limited and Pokansing Investment Limited, each holding
50% of the limited partnership interest. Sunet Global Limited is
wholly owned by Wang Jian, an Independent Third Party, and
Pokansing Investment Limited is wholly owned by Zheng Jiayi,
an Independent Third Party. The general partner of Huagai USD
is Huagai Healthcare Investment Company Limited, an exempted
company incorporated in the Cayman Islands and ultimately
controlled by XU Xiaolin (؍an Independent Third Party.
Huagai USD primarily focuses on early stage investment in
biotech and medtech companies with cutting edge technology and
has invested in several healthcare and biotech companies,
including PAQ Therapeutics.
CSVC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118CSVC is an investment services flagship which is directly and
wholly-owned by Suzhou Oriza Holdings Co., Ltd (ٰ
ʮ̡). (“ Oriza Holdings ”). Oriza Holdings’ primary
investment focus is early-stage and growth-stage enterprises and
Oriza Holdings has previously invested in healthcare companies
such as Innovent Biologics, Inc., a company listed on the Stock
Exchange (stock code: 1801), JW (Cayman) Therapeutics, a
company listed on the Stock Exchange (stock code: 2126),
Ascentage Pharma, a company listed on the Stock Exchange
(stock code: 6855). Oriza Holdings is ultimately controlled by
Suzhou Industrial Park Administrative Committee ( ᘽψʈุ෤ਜ
ึ), which is an Independent Third Party.
Tai Kun /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Tai Kun is a limited partnership incorporated in the PRC, which
is held as to 1% by its general partner, Hangzhou Tailong V enture
Capital Partnership Enterprise (Limited partnership) (ψइᘡ௴
ุҳ༟ΥྫΆุ(Υྫ)) (“ Hangzhou Tailong ”), and 99% by
its limited partner, Hangzhou Taikun Equity Investment Fund
Partnership (Limited Partnership) (ΥྫΆ
ุ(Υྫ)) (“ Hangzhou Taikun ”).
HISTORY AND CORPORATE STRUCTURE
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Pre-IPO Investors Background
Hangzhou Taikun is a limited liability partnership established in
the PRC on August 10, 2021 and is an investment fund registered
under the Asset Management Association of China with an
aggregate amount of assets under management of approximately
RMB20.0 billion. Hangzhou Taikun primarily focuses on
investment opportunities in companies which engage in
development of innovative medical devices and medicine,
medical services, etc. Hangzhou Taikun has three limited
partners, with the largest limited partner holding approximately
49.00%, and none of the other limited partners holding more than
30%. The general partner and fund manager of Hangzhou Taikun
is Hangzhou Tailong.
The general partner of Hangzhou Tailong is Zhaotai (Zibo)
V enture Capital Management Partnership (Limited Partnership)
(इ(଍௹)௴ุҳ༟၍ଣΥྫΆุ(Υྫ)), the general
partner of which is Mr. LIU Chunguang (Έ), an Independent
Third Party, holding approximately 99% partnership interest
therein.
As of the Latest Practicable Date, approximately 49% and 99% of
the respective interest in Hangzhou Taikun and Hangzhou Tailong
was held by their respective largest limited partner, Hangzhou
Tigermed Equity Investment Partnership (Limited Partnership)
(ᛆҳ༟ΥྫΆุ(Υྫ)), which is a wholly-
owned subsidiary of Tigermed Consulting Co., Ltd. (ᔼ
ʮ̡), a biopharmaceutical company dually
listed on the Stock Exchange (stock code: 3347) and the
Shenzhen Stock Exchange (stock code: 300347). Tai Kun and its
general partner and limited partners are all Independent Third
Parties.
AZ-CICC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118AZ-CICC Fund I is a limited partnership incorporated in the PRC,
the general partners of which are AstraZeneca Investment
Consulting (Wuxi) Co., Ltd. (౶лੰਠਕፔ༔(ೌ፼)ʮ̡)
(“AstraZeneca Investment Consulting ”) and CICC Private
Equity Management Co., Ltd. (ʮ̡)
(“CICC Capital Management ”). The limited partners of AZ-
CICC Fund I are Independent Third Parties.
HISTORY AND CORPORATE STRUCTURE
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Pre-IPO Investors Background
AZ-CICC Fund II is a limited partnership incorporated in the
PRC, the general partners of which are AstraZeneca Investment
Consulting and CICC Capital Management. The limited partners
of AZ-CICC Fund II are Independent Third Parties.
CICC Capital Management is a wholly-owned subsidiary of
China International Capital Corporation Limited (ፄ
ʮ̡), a company listed on the Stock Exchange (stock
code: 3908) and Shanghai Stock Exchange (stock code: 601995).
AstraZeneca Investment Consulting is a wholly-owned subsidiary
of AstraZeneca Investment (China) Co., Ltd. (౶лੰҳ༟(ʕ਷)
ʮ̡) and these entities are indirectly wholly-owned
subsidiaries of the parent company AstraZeneca PLC
(“AstraZeneca ”), a public limited company with the principal
markets for trading on the London Stock Exchange, Nasdaq
Stockholm and Nasdaq Global Select Market (symbol: AZN) and
an Independent Third Party. AstraZeneca is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
oncology, rare diseases, and biopharmaceuticals, including
cardiovascular, renal & metabolism, and respiratory &
immunology. Based in Cambridge, UK, AstraZeneca’s innovative
medicines are sold in more than 125 countries and used by millions
of patients worldwide. AstraZeneca has invested in a number of
healthcare and biotech companies including Abbisko Cayman
Limited (ப΂ʮ̡), a company listed on the Stock
Exchange (stock code: 2256) and Dizal Pharmaceutical Co., Ltd.
(ࡪࠔ(Ϫᘽ)ʮ̡), a company listed on the Shanghai
Stock Exchange (stock code: 688192).
Therefore, each of AZ-CICC Fund I and AZ-CICC Fund II is
ultimately beneficially owned by each of CICC and AstraZeneca.
HISTORY AND CORPORATE STRUCTURE
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Pre-IPO Investors Background
Shenglian /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Shenglian is a limited partnership incorporated in the PRC.
Xiamen Jingman Technology Partnership (Limited Partnership)
(ҦΥྫΆุ(Υྫ)), a limited partner of
Shenglian which is owned as to 65% by Lin Y uehua (ᚔശ) and
35% by Zhang Y uxing ( ੵ༃ጳ), both of whom are Independent
Third Parties, holds approximately 31.38% interest in Shenglian,
with none of the other limited partners holding more than 30%
interest in Shenglian. The general partner of Shenglian is Xiamen
Qisheng V enture Capital Co., Ltd. (ʮ
̡)( “ Qisheng Venture Capital ”), which is controlled by
Septwolves Group Holding CO., LTD. (ࠢ
ʮ̡)( “ Septwolves Group ”). Septwolves Group is ultimately
controlled by Zhou Y ongwei, Zhou Shaoxiong and Zhou
Shaoming, each of whom is an Independent Third Party. As of the
Latest Practicable Date, Qisheng V enture Capital had assets under
management of approximately RMB2 billion. Its investment
portfolio includes, among others, Pyrotech (Beijing)
Biotechnology Co., Ltd (ʮ̡),
XpectVision Technology Co., Ltd (ʮ̡)
and Bluepha Co., Ltd (ʮ̡).
SW Biotech /H1118/H1118/H1118/H1118/H1118/H1118/H1118SW Biotech is a limited partnership fund registered in Hong
Kong. Hong Kong Li Hong Company Limited, a limited partner
of SW Biotech, holds approximately 60.34% interest in SW
Biotech, while no other limited partner holds more than 30%
interest. Hong Kong Li Hong Company Limited is ultimately
wholly owned by Chen Pengling, an Independent Third Party. The
general partner of SW Biotech is Hong Kong Wang Yick
Investment Limited, a company registered in Hong Kong and
wholly owned by TSAI Y an Y an ( ᇹতত), an Independent Third
Party. SW Biotech is primarily engaged in investments. As of the
Latest Practicable Date, SW Biotech’s investment portfolio
consists solely of its investment in the Company.
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Pre-IPO Investors Background
Tasly International
Capital /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Tasly International Capital is a company incorporated under the
laws of the BVI with limited liability on February 28, 2014 which
is indirectly wholly owned by Tasly Bio-Medicine Industry
Group Co., Ltd. (ʮ̡)( “ Tasly
Group ”) and mainly focuses on overseas equity investment.
Tasly Group business covers biopharmaceuticals, health care
management, medical services, and investment in the healthcare
industry which is ultimately controlled by Mr. Y AN Kaijing ( ₢
௱ྤ), an Independent Third Party. Tasly Group has invested in a
number of healthcare and biotech companies including Tasly
Pharmaceutical Group Co., Ltd. (ʮ̡),
a company listed on the Shanghai Stock Exchange (stock code:
600535), Dingdang Health Technology Group Ltd. (߅
ʮ̡), a company listed on the Stock Exchange (stock
code: 9886), ClouDr Group Limited (Ҧණྠ), a
company listed on the Stock Exchange (stock code: 9955), and
BrainAurora Medical Technology Limited (ҦϞ
ʮ̡), a company listed on the Stock Exchange (stock code:
6681).
Hoi Pok /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Hoi Pok is a sole proprietorship registered in Hong Kong in
accordance with the Business Registration Ordinance (Chapter
310 of the Laws of Hong Kong) and is wholly controlled by Ms.
Chau Nga Chun, an Independent Third Party. Hoi Pok is
principally engaged in investment holding activities.
Hankang /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Hankang Biotech Fund III, L.P . is a limited partnership
established in the Cayman Islands and is managed by Hankang
Biotech III, LLC, which is ultimately owned by Ms. Meichai
Zhang. Carob Investment Pte Ltd, a limited partner, holds
approximately 37.23% interest in Hankang Biotech Fund III, L.P .,
while no other limited partner holds more than 30% interest.
Splendid Biotech Fund L.P . is a limited partnership established in
the Cayman Islands and is managed by Pole Star Biotech LLC,
which is ultimately owned by Mr. Quanhong Y uan. The sole
limited partner of Splendid Biotech Fund L.P . is Carob
Investment Pte Ltd. Carob Investment Pte Ltd is wholly owned by
GIC (V entures) Pte. Ltd., which in turn is an affiliate of GIC Pte.
Ltd. (“ GIC”). GIC is a global investment firm established in 1981
to manage Singapore’s foreign reserves. Each of Ms. Meichai
Zhang, Mr. Quanhong Y uan and GIC is an Independent Third
Party.
HISTORY AND CORPORATE STRUCTURE
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Pre-IPO Investors Background
Each of Hankang Biotech Fund III, L.P ., Splendid Biotech Fund
L.P ., Hankang Biotech III, LLC and Pole Star Biotech LLC is
operated under Hankang Capital. Hankang Capital is a venture
capital fund committed to the pharmaceutical and biotechnology
industry with the mission to empower biomedical innovation and
safeguard life wellness.
Hankang Capital has established strong partnership with
pioneering scientists and top-notch entrepreneurs to develop
breakthrough new drugs for treatment of major diseases with
great unmet clinical needs. Hankang Capital is based in China
and with a global vision, many of Hankang Capital’s portfolio
companies have become industry-leading enterprises, such as
Akeso, Inc., a company listed on the Stock Exchange (stock code:
9926), InnoCare Pharma Limited, a company dually listed on the
Shanghai Stock Exchange (stock code: 688428) and the Stock
Exchange (stock code: 9969), Keymed Biosciences Inc., a
company listed on the Stock Exchange (stock code: 2162),
Shenzhen Chipscreen Biosciences Co., Ltd., a company listed on
the Shanghai Stock Exchange (stock code: 688321), Abbisko
Cayman Limited, a company listed on the Stock Exchange (stock
code: 2256) and Shanghai Opm Biosciences Co., Ltd., a company
listed on the Shanghai Stock Exchange (stock code: 688293). As
of the Latest Practicable Date, Hankang Capital has assets under
management of approximately USD700 million.
Special Rights of the Pre-IPO Investors
All Preferred Shares will be converted into Shares of our Company on a one to one basis
immediately prior to the completion of the Global Offering. All Shareholders (including our
Pre-IPO Investors) are bound by (i) the terms of the existing memorandum and articles of
association of our Company which will be replaced by our Articles effective upon the Listing,
(ii) the shareholders’ agreement dated September 19, 2022 entered into by, among others, the
Company and our Shareholders (the “ Shareholders’ Agreement ”), and (iii) the agreement in
respect of certain rights entered into by, among others, the Company and our Shareholders (the
“Agreement in respect of Certain Rights ”) dated August 25, 2024.
HISTORY AND CORPORATE STRUCTURE
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Pursuant to the Shareholders’ Agreement, the Pre-IPO Investors were granted certain
special rights, including, among other rights, (i) information and inspection rights; (ii)
pre-emptive rights; (iii) rights of first refusal; (iv) co-sale rights; (v) Board representation; (vi)
liquidation preferences; (vii) registration rights; (viii) redemption rights; and (ix) prohibitions
on transfers.
Pursuant to the Agreement in respect of Certain Rights, (i) the redemption rights of the
Pre-IPO Investors will be terminated immediately upon the first filing of the listing application
by the Company with the Stock Exchange (the “ First Submission Date ”), but shall again
become exercisable upon the earliest of (a) the withdrawal of the listing application by the
Company; (b) the rejection of the listing application by the Stock Exchange; or (c) the
expiration of eighteen (18) months after the First Submission Date, and (ii) all other special
rights of the Pre-IPO Investors will be automatically terminated upon the completion of the
Listing. No special rights granted to the Pre-IPO Investors will survive after the Listing.
Compliance with the Listing Guide
On the basis that (i) the Listing will take place more than 120 clear days after the
completion of the Pre-IPO Investments, and (ii) the termination of special rights granted to the
Pre-IPO Investors as disclosed in “— Special Rights of the Pre-IPO Investors” above, the Joint
Sponsors confirm that the Pre-IPO Investments are in compliance with Chapter 4.2 of the
Listing Guide.
Public Float
The Shares held by LA V USD and Founder Holdco will not be considered as part of the
public float for the purpose of Rule 8.08 of the Listing Rules as (i) LA V USD will be a
substantial shareholder of the Company and thus a core connected person of the Company; (ii)
LA V Star Opportunities Limited, a cornerstone investor of the Company, is a close associate
of LA V USD and thus a core connected person of the Company; and (iii) Founder Holdco is
a company wholly owned by Dr. ZHU Zhongyuan, who is a Director and thus a core connected
person of the Company.
Therefore, a total of 23,165,421 Shares, representing approximately 27.85% of our
Company’s total issued Shares immediately following the completion of the Global Offering,
assuming an Offer Price of HK$98.90 per Share, being the mid-point of the indicative Offer
Price range stated in this prospectus, and that the Offer Size Adjustment Option and the
Over-allotment Option are not exercised, will not be considered as part of the public float upon
the Listing for the purpose of Rule 8.08 of the Listing Rules after the Global Offering.
To our Directors’ best knowledge, each of the other Pre-IPO Investors is an Independent
Third Party. Accordingly, Shares held by them will be counted towards the public float for the
purpose of Rule 8.08 of the Listing Rules after the Global Offering.
HISTORY AND CORPORATE STRUCTURE
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Save as disclosed above, to the best of our Directors’ knowledge, all other Shareholders
of our Company are not core connected persons of the Company. As a result, over 25% of the
Company’s total issued Shares will be held by the public upon completion of the Global
Offering as required under Rule 8.08(1)(a) of the Listing Rules. In addition, the market
capitalization of the portion of the total number of the Company’s issued Shares held by the
public pursuant to the requirements under Rule 18A.07 of the Listing Rules (based on the Offer
Price of HK$98.90, being the mid-point of the indicative Offer Price range) would be over
HK$375 million at the time of the Listing.
SHARE INCENTIVE PLAN OF THE COMPANY
As of the Latest Practicable Date, we had one share incentive scheme, namely the Pre-IPO
Equity Incentive Plan, the terms of which are not subject to the provisions of Chapter 17 of the
Listing Rules. For further details of the Pre-IPO Equity Incentive Plan, please see “Statutory
and General Information — D. Share Incentive Plan — Pre-IPO Equity Incentive Plan” in
Appendix IV to this prospectus.
ACQUISITIONS AND DISPOSALS
Acquisition during the Track Record Period
In order to streamline our operations and mitigate potential competition, in November
2024, our Group acquired the entire equity interests from the then shareholders of Duality
Beijing, namely Dr. ZHU Zhongyuan (our Director and chief executive officer, a connected
person of our Company), Mr. ZHU Fuyuan (the brother of Dr. ZHU Zhongyuan, a connected
person of our Company) and LO’ HK LIMITED (an Independent Third Party) for nil
consideration, which was determined on an arm’ length basis with reference to the valuation
report prepared by an independent qualified professional valuer, taking into account that
Duality Beijing was a holding company and had no actual business operations. At the time of
completion of the acquisition, Duality Beijing did not have any outstanding liabilities.
Major Acquisitions and Disposals
We did not conduct any material acquisitions, mergers or disposals during the Track
Record Period and up to the Latest Practicable Date that we consider significant to our
business.
HISTORY AND CORPORATE STRUCTURE
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OUR SUBSIDIARIES
As of the Latest Practicable Date, we have five subsidiaries, detailed information of
which is set out below:
Name
Date of
establishment/
incorporation
Place of
establishment/
incorporation Principal business activities
DualityBio HK /H1118/H1118/H1118/H1118/H1118January 21,
2020
Hong Kong Investment holding
Duality Suzhou /H1118/H1118/H1118/H1118/H1118March 23,
2020
PRC Investment holding and
pharmaceuticals
research, development
and production
Duality Shanghai /H1118/H1118/H1118/H1118April 26, 2020 PRC Pharmaceuticals research,
development and
production
Duality US /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118May 3, 2021 Delaware, the
United States
Pharmaceuticals research
and development
Duality Beijing /H1118/H1118/H1118/H1118/H1118January 9,
2020
PRC No material business
activities
REASON FOR THE LISTING
Our Company is seeking a listing of its Shares on the Stock Exchange in order to
primarily provide further capital for (i) research, development and commercialization of our
Core Products; (ii) research and development of our key products; and (iii) continued
development of our ADC technology platforms, advancement of our other pipeline assets, and
exploration and development of new drug assets, as described in more details in “Future Plans
and Use of Proceeds” in this prospectus.
HISTORY AND CORPORATE STRUCTURE
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SHAREHOLDING STRUCTURE OF OUR COMPANY AS OF THE LISTING DATE
The shareholding structure of our Company as of the Latest Practicable Date and immediately upon completion of the Global Offering,
assuming the Offer Size Adjustment Option and the Over-allotment Option are not exercised is set forth below:
As of the Latest
Practicable Date
Immediately upon
completion of the Global
Offering, assuming the
Offer Size Adjustment
Option and the Over-
allotment Option are
not exercised
Shareholders
Ordinary
Shares
Series Seed
Preferred
Shares
Series A-1
Preferred
Shares
Series A-2
Preferred
Shares
Series B-1
Preferred
Shares
Series B-2
Preferred
Shares
Aggregate
number of
Shares
Aggregate
ownership
percentage
Number of
Shares
Ownership
percentage
Founder Holdco /H1118/H1118/H1118/H1118/H1118/H1118/H11186,000,000 500,000 –––– 6,500,000 (1) 9.54% 6,500,000 7.81%
APHN /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 1,500,000 –––– 1,500,000 2.20% 1,500,000 1.80%
King Star Med /H1118/H1118/H1118/H1118/H1118/H1118/H1118– 1,000,000 5,589,554 – – – 6,589,554 9.68% 6,589,554 7.92%
Golden Sword /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 3,333,333 3,333,333 – – 3,333,333 4.89% 3,333,333 4.01%
WuXi V enture /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – – 2,666,667 833,333 669,643 4,169,643 6.12% 4,169,643 5.01%
LA V Fund VI /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– 6,250,000 5,022,321 11,272,321 16.55% 11,272,321 13.55%
LA V Opportunities /H1118/H1118/H1118/H1118/H11182,000,000 2,000,000 1,000,000 – – – 5,000,000 7.34% 5,393,100 (2) 6.48%
Green Pine /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– 1,041,667 837,054 1,878,721 2.76% 1,878,721 2.26%
Huagai USD /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– 583,333 – 583,333 0.86% 583,333 0.70%
Orchids /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– 2,083,333 1,674,107 3,757,440 5.52% 3,757,440 4.52%
Shenzhen Huagai /H1118/H1118/H1118/H1118/H1118/H1118–––– 625,000 – 625,000 0.92% 625,000 0.75%
Suzhou Huagai /H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– 41,667 1,674,107 1,715,774 2.52% 1,715,774 2.06%
Tianjin Huagai /H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– 833,333 – 833,333 1.22% 833,333 1.00%
Shanghai Yingjia /H1118/H1118/H1118/H1118/H1118/H1118–––– 3,541,667 2,845,982 6,387,649 9.38% 6,387,649 7.68%
CSVC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–––– 833,333 1,674,107 2,507,440 3.68% 2,507,440 3.01%
HISTORY AND CORPORATE STRUCTURE
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As of the Latest
Practicable Date
Immediately upon
completion of the Global
Offering, assuming the
Offer Size Adjustment
Option and the Over-
allotment Option are
not exercised
Shareholders
Ordinary
Shares
Series Seed
Preferred
Shares
Series A-1
Preferred
Shares
Series A-2
Preferred
Shares
Series B-1
Preferred
Shares
Series B-2
Preferred
Shares
Aggregate
number of
Shares
Aggregate
ownership
percentage
Number of
Shares
Ownership
percentage
SW Biotech /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118––––– 1,674,107 1,674,107 2.46% 1,674,107 2.01%
Shenglian /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118––––– 1,506,696 1,506,696 2.21% 1,506,696 1.81%
AZ-CICC Fund I /H1118/H1118/H1118/H1118/H1118/H1118––––– 1,674,107 1,674,107 2.46% 1,674,107 2.01%
AZ-CICC Fund II /H1118/H1118/H1118/H1118/H1118––––– 1,674,107 1,674,107 2.46% 1,674,107 2.01%
Tai Kun /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118––––– 1,506,696 1,506,696 2.21% 1,506,696 1.81%
Tasly International
Capital /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118––––– 1,004,464 1,004,464 1.47% 1,004,464 1.21%
Hoi Pok /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 1,205,223 – – – 1,205,223 1.77% 1,205,223 1.45%
Hankang Biotech
Fund III, L.P . /H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 803,482 – – – 803,482 1.18% 803,482 0.97%
Splendid Biotech
Fund L.P . /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 401,741 – – – 401,741 0.59% 401,741 0.48%
Other Public
Shareholders /H1118/H1118/H1118/H1118/H1118/H1118/H1118–––––––– 14,678,500 17.65%
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,000,000 5,000,000 12,333,333 2,666,667 16,666,666 23,437,498 68,104,164 100.00% 83,175,764 100.00%
HISTORY AND CORPORATE STRUCTURE
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--- page 295 ---
Notes:
(1) Founder Holdco is entitled to exercise the voting rights attached to 2,000,000 Ordinary Shares held by LA V Opportunities pursuant to the V oting Ri ghts Proxy Agreement, which
will terminate upon completion of the Global Offering. For details, see “— V oting Rights Proxy Agreement”.
(2) Includes the Offer Shares (calculated based on the Offer Price of HK$98.90, being the mid-point of the indicative Offer Price range) to be subscrib ed by LA V Star Opportunities
Limited (“ LA V Star”), a wholly-owned subsidiary of LA V Opportunities, as a cornerstone investor. For details, see “Cornerstone Investors”.
HISTORY AND CORPORATE STRUCTURE
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PRC LEGAL COMPLIANCE
Our PRC Legal Advisor has confirmed that each of the capital increase and incorporation
of our PRC subsidiaries have been legally completed and the requisite government approvals
or filings in all material respects, as applicable, have been obtained in accordance with PRC
laws and regulations.
M&A RULES
The M&A Rules require that foreign investors acquiring domestic companies by means
of asset acquisition or equity acquisition shall comply with relevant foreign investment
industry policies and shall be subject to approval by the relevant commerce authorities. Article
11 of the M&A Rules stipulates that an offshore special purpose vehicle, or a SPV , established
or controlled by a PRC company or individual shall obtain approval from MOFCOM prior to
the acquisition of any domestic enterprise related to such company or individual. The M&A
Rules, among others, also require that an offshore SPV formed for listing purposes and
controlled directly or indirectly by PRC companies or individuals, shall obtain the approval of
the CSRC prior to the listing and trading of such SPV’s securities on an overseas stock
exchange.
As advised by our PRC Legal Advisor, the MOFCOM approvals or CSRC approvals under
the M&A Rules are not required because Duality Suzhou was established at the beginning as
a foreign-invested enterprise in the PRC, rather than become foreign-invested enterprises
through merger or acquisition under the M&A Rules. However, there is uncertainty as to how
the M&A Rules will be interpreted or implemented and whether the MOFCOM and other
related government authorities would promulgate future PRC laws, regulations or rules
contrary to the M&A Rules.
SAFE Registration
Pursuant to the SAFE Circular 37 which became effective on July 4, 2014, PRC residents
are required to register with SAFE or its local branch in connection with their establishment
or control of an offshore SPV established for the purpose of overseas investment or financing.
Pursuant to the Circular on Further Simplifying and Improving the Foreign Exchange
Management Policies for Direct Investment (Hui Fa [2015] No. 13) (ආɓӉᔊʷձҁഛ
(ි೯[2015]13 ໮)) (the “ SAFE Circular 13 ”), promulgated
by SAFE in February 2015 and amended on December 30, 2019, banks are required to review
and carry out foreign exchange registration under offshore direct investment directly. The
SAFE and its branches shall implement indirect supervision over foreign exchange registration
of direct investment via the banks.
HISTORY AND CORPORATE STRUCTURE
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--- page 297 ---
As advised by our PRC Legal Advisor, Dr. ZHU, who is required to complete the
registration under SAFE Circular 37 and SAFE Circular 13, has completed the foreign
exchange initial registration in January 2020 in relation to his offshore investments as a PRC
resident.
OUR SHAREHOLDING AND CORPORATE STRUCTURE
Immediately Prior to the Global Offering
Our corporate and shareholding structure immediately prior to the completion of the
Global Offering is as follows:
Company
(Cayman Islands)
Duality US
(Delaware, the United States)
100% 100%
100%
23.89%
LAV USD(1)(2)
9.68%
King Star Med
9.54%
Founder
Holdco(2)
9.38%
Shanghai
Yingjia
6.12%
WuXi Venture
5.52%
Orchids
35.52%
Other Pre-IPO
Investors(3)
DualityBio HK
(HK)
Duality Suzhou
(PRC)
100%
Duality Shanghai
(PRC)
100%
Duality Beijing
(PRC)
offshore
onshore
Notes:
(1) As of the Latest Practicable Date, 2,000,000 Ordinary Shares, 2,000,000 Series Seed Preferred Shares,
1,000,000 Series A-1 Preferred, 6,250,000 Series B-1 Preferred Shares and 5,022,321 Series B-2 Preferred
Shares were held by LA V USD, among which (i) 6,250,000 Series B-1 Preferred Shares and 5,022,321 Series
B-2 Preferred Shares were held by LA V Fund VI; and (ii) 2,000,000 Ordinary Shares, 2,000,000 Series Seed
Preferred Shares and 1,000,000 Series A-1 Preferred Shares were held by LA V Opportunities.
(2) Founder Holdco is entitled to exercise the voting rights attached to 2,000,000 Ordinary Shares held by LA V
Opportunities pursuant to the V oting Rights Proxy Agreement, which will terminate upon completion of the
Global Offering. For details, see “— V oting Rights Proxy Agreement”.
(3) As of the Latest Practicable Date, other Pre-IPO Investors includes APHN (1,500,000 Preferred Shares),
Golden Sword (3,333,333 Preferred Shares), Green Pine (1,878,721 Preferred Shares), Huagai USD (583,333
Preferred Shares), Shenzhen Huagai (625,000 Preferred Shares), Suzhou Huagai (1,715,774 Preferred Shares),
Tianjin Huagai (833,333 Preferred Shares), CSVC (2,507,440 Preferred Shares), SW Biotech (1,674,107
Preferred Shares), Shenglian (1,506,696 Preferred Shares), AZ-CICC Fund I (1,674,107 Preferred Shares),
AZ-CICC Fund II (1,674,107 Preferred Shares), Tai Kun (1,506,696 Preferred Shares), Tasly International
Capital (1,004,464 Preferred Shares), Hoi Pok (1,205,223 Preferred Shares), Hankang Biotech Fund III, L.P .
(803,482 Preferred Shares), and Splendid Biotech Fund L.P . (401,741 Preferred Shares).
HISTORY AND CORPORATE STRUCTURE
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Immediately Following the Global Offering
The following chart sets forth our corporate and shareholding structure upon the
completion of the Global Offering, assuming the Offer Size Adjustment Option and the
Over-allotment Option are not exercised:
Company
(Cayman Islands)
100% 100%
100%
DualityBio HK
(HK)
Duality Suzhou
(PRC)
Duality US
(Delaware, the United States)
offshore
onshore
20.04%
LAV USD(1)
7.92%
King Star Med
7.81%
Founder
Holdco
7.68%
Shanghai
Yingjia
4.52%
Orchids
29.37%
Other Pre-IPO
Investors(2)
17.65%
Other Public
Shareholders
5.01%
WuXi Venture
100%
Duality Shanghai
(PRC)
100%
Duality Beijing
(PRC)
Notes:
(1) Immediately following the Global Offering, 16,665,421 Shares will be held by LA V USD, among which (i)
11,272,321 Shares will be held by LA V Fund VI; (ii) 5,000,000 Shares will be held by LA V Opportunities; and
(iii) 393,100 Shares (calculated based on the Offer Price of HK$98.90, being the mid-point of the indicative
Offer Price range) will be held by LA V Star, a wholly-owned subsidiary of LA V Opportunities, as a cornerstone
investor. For details, see “Cornerstone Investors”.
(2) Immediately following the Global Offering, other Pre-IPO Investors includes APHN (1,500,000 Shares),
Golden Sword (3,333,333 Shares), Green Pine (1,878,721 Shares), Huagai USD (583,333 Shares), Shenzhen
Huagai (625,000 Shares), Suzhou Huagai (1,715,774 Shares), Tianjin Huagai (833,333 Shares), CSVC
(2,507,440 Shares), SW Biotech (1,674,107 Shares), Shenglian (1,506,696 Shares), AZ-CICC Fund I
(1,674,107 Shares), AZ-CICC Fund II (1,674,107 Shares), Tai Kun (1,506,696 Shares), Tasly International
Capital (1,004,464 Shares), Hoi Pok (1,205,223 Shares), Hankang Biotech Fund III, L.P . (803,482 Shares), and
Splendid Biotech Fund L.P . (401,741 Shares).
HISTORY AND CORPORATE STRUCTURE
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OVERVIEW
Who we are. We are a key player in the global antibody-drug conjugate (“ ADC”)
landscape, dedicated to the development of innovative therapeutics in this fast-growing drug
modality to treat cancer, autoimmune diseases, and beyond. Leveraging our technology
platforms and a differentiated, clinically advanced pipeline, we aim to deliver transformative
treatments that improve patient outcomes.
Since our inception, we have focused primarily on the independent discovery and
development of ADC assets. We have assembled a highly experienced team of experts in all
facets of ADC drug development. Leveraging our experienced R&D team, insights into ADC
design, and strong execution capabilities, we have established four cutting-edge ADC
technology platforms to push the boundaries of ADC treatment and a pipeline of 12 internally
discovered ADC candidates covering a diverse range of indications. As recognition of the
clinical and commercial value of our platforms and pipeline, we have forged several global
partnerships to date with a total deal value of over US$6.0 billion, enabling us to accelerate the
delivery of our ADC drugs to patients around the world.
We know how to create differentiated ADCs. From target selection, ADC design to
clinical development, we build on the extensive experience of major players in the ADC space
and have accumulated deep knowledge in this rising modality. This expertise has allowed us
to stand out among the pioneers in this domain, harnessing proprietary next-generation ADC
platform technologies and address unmet medical needs worldwide, according to Frost &
Sullivan.
We strive to be at the forefront of ADC technologies and development strategies. Our
pipeline of 12 in-house discovered ADC candidates is a testament to our prowess in ADC
innovation, comprising: (i) seven clinical-stage ADCs with potential in a broad range of
indications, each ranking among the most clinically advanced globally in terms of overall or
lead indication development progress, according to Frost & Sullivan; (ii) two next-generation
bispecific ADCs (“ BsADCs ”) that are expected to enter into clinical stage from 2025 to 2026;
and (iii) multiple other preclinical ADCs. Three of our clinical-stage assets, including our Core
Products DB-1303/BNT323 and DB-1311/BNT324 and key product DB-1305/BNT325, have
received Fast Track Designation from the United States Food and Drug Administration (the
“FDA”), and DB-1303 has received Breakthrough Therapy Designations from both the FDA
and the National Medical Products Administration (the “ NMPA”), for certain indications.
DB-1303 is a late clinical-stage HER2 ADC candidate with two ongoing registrational trials
(one global trial and one in China) and one potential global registrational study, with the first
indication (HER2-expressing endometrial cancer (“ EC”)) projected to file for accelerated
approval with the FDA as early as 2025.
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We have set our sights on the global market and aspire to treat patients worldwide.
We have designed our ADC drug candidates to be competitive with, or differentiated from,
those of the leading global ADC players. All of our clinical-stage assets had obtained
investigational new drug (“ IND”) approvals from both the FDA and the NMPA as of the Latest
Practicable Date. We have seven ongoing global multi-regional clinical trials (“ MRCTs”)
across 17 countries and over 230 trial sites, with over 2,000 patients (more than 50% located
in the U.S., EU, Australia and other regions outside China) enrolled as of the Latest Practicable
Date, including four conducted in collaboration with our strategic partners for which we are
currently acting as the trial sponsor. Our innovative ADC assets have attracted global
biopharmaceutical companies, culminating in several global partnerships to date, including
with BioNTech SE (“ BioNTech ”), BeiGene, Ltd. (“ BeiGene ”), Adcendo ApS (“ Adcendo ”),
GSK plc (“ GSK”), and Avenzo Therapeutics, Inc. (“ Avenzo ”), with over US$6.0 billion in total
deal value (of which approximately US$500 million had been received as of the Latest
Practicable Date).
We implement our strategies with industry-leading clinical development and
execution capabilities. Within just four years since our inception, seven of our ADC
candidates have advanced from program initiation to IND approval. DB-1303 advanced from
first-patient-in to end-of-phase 2 (“ EOP2 ”) meeting with the FDA in just 20 months and is
projected to file for accelerated approval with the FDA as early as 2025, within four years after
the first patient was dosed. We strive to achieve breakthroughs in ADC technology and execute
our global drug development strategies at a pace that keeps us at the forefront of the industry.
A D C=C P
2 — Our Development Formula
CP2 embodies our formula for compounded success and growth. “C” represents our
Clinical development strategy, emphasizing our systematic approach in key aspects of clinical
development and operations. The first “P” stands for our in-house developed ADC technology
Platforms, which underscore our innovative prowess, and the second “P” stands for our robust
Pipeline, which showcases our strategic target selection and clinical development capabilities.
Our In-house Developed ADC Platforms
Leveraging our experienced R&D team, insights into ADC design, and strong execution
capabilities, we have established four cutting-edge ADC technology platforms: DITAC,
DIBAC, DIMAC, and DUPAC, to push the boundaries of ADC treatment. Our technology
platforms serve as the foundation for continuous and sustained innovation and value creation,
whose value and versatility have been validated by our pipeline assets and recognized by global
multinational corporation (“ MNC”) partners.
BUSINESS
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1 preclinical asset 1 clinical asset
2 preclinical assets
5 clinical assets
3 preclinical assets
1 clinical asset
DITAC
Duality Immune Toxin Antibody Conjugate
DIMAC
Duality Immune Modulating Antibody Conjugate
DUPAC
Duality Unique Payload Antibody Conjugate
DIBAC
Duality Innovative Bispecific Antibody Conjugate
• Leading topoisomerase-based ADC platform
• Higher therapeutic window with enhanced toxin and linker,
bringing improved efficacy and safety
• Good tolerability profile demonstrated in over 2,000 patients
• First-in-class ADC platform for autoimmune diseases
• “Smart steroid” targeted delivery of steroid with limited
exposure to normal tissue
• Superior to traditional antibody therapy in efficacy
• Enhanced tumor selectivity via two tumor antigen binding
• Function synergy and pathway cross-talk
• Potential best-in-class and frontline therapy
• Potential to overcome resistance to Dxd (TOP1i)
• Targeting hard-to-treat tumor types with promising efficacy
• Potential to reshape the ADC treatment paradigm
Notes:
Topoisomerase: An enzyme that plays an essential role in DNA replication and transcription. By targeting
topoisomerase, ADCs derived from our DITAC platform can potentially treat various solid tumors
by inhibiting DNA replication and inducing DNA damage in cancer cells.
Payload: Therapeutic agents delivered to the target area.
Linker: Molecule that connects the payload to the antibody of an ADC to deliver the therapeutic agent to
target cells.
 Duality Immune Toxin Antibody Conjugate (DITAC) , our proprietary topoisomerase
inhibitor-based ADC platform, is validated by the global clinical data from over
2,000 patients across the U.S., China, Europe, Australia and other major markets.
Compared to non-topoisomerase ADCs, Topoisomerase-based ADCs have
demonstrated a wide therapeutic window which potentially translates into improved
efficacy and safety in the clinical setting. This platform is developed by screening
and optimizing a library of proprietary ADC components, including our proprietary
payloads P1003 and P1021, through meaningful technological improvements. As
such, DITAC provides critical flexibility to design our ADCs with improved
systemic stability, tumor-specific payload release, bystander-killing effects, and
rapid payload clearance.
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 Duality Innovative Bispecific Antibody Conjugate (DIBAC) , one of the few BsADC
platforms in the world, is leading a new wave of ADC innovation. BsADCs can
potentially offer improved efficacy over traditional monospecific ADCs and their
combination therapies, by incorporating two distinct binding moieties in a single
therapeutic entity. While promising, the complexity of BsADCs introduces new
challenges in antibody engineering, stability and manufacturing, setting a high entry
barrier. Our innovative DIBAC platform features our understanding of disease and
target biology, rich experience in bispecific antibody engineering, and artificial
intelligence-enabled target selection and antibody design.
 Duality Immune-Modulating Antibody Conjugate (DIMAC) , supported by our
proprietary immune-modulating payload, holds the potential to open the ADC
modality to a significant white-space market in autoimmune and other therapeutic
areas. DIMAC is one of the very few ADC platforms in the world that targets major
autoimmune diseases. Many patients with chronic autoimmune diseases, such as
SLE and CLE, are currently treated with therapies that often lead to severe side
effects. Long term use of glucocorticoids, for example, are commonly associated
with increased risks of bone fractures, weight gain, diabetes, immune system
suppression, and other chronic conditions. We believe ADCs can reshape the
treatment paradigm of autoimmune diseases by offering a targeted treatment with
low systemic exposure, enhanced efficacy and reduced side effects. Molecules
designed under our DIMAC platform have demonstrated potent and broad anti-
inflammatory activity, long duration of action, sustained stability, and low systemic
exposure in preclinical studies.
 Duality Unique Payload Antibody Conjugate (DUP AC) reflects our foresight into the
future landscape of ADC innovation. DUPAC is one of the few ADC platforms
globally dedicated to the development of linker-payload complexes with novel
mechanisms of action, beyond traditional cytotoxic agents, to combat growing drug
resistance and hard-to-treat tumors. We have made promising progress in a number
of unique payload mechanisms and have obtained prototypes with broad-spectrum
anti-tumor activity across multiple solid tumors, and potent direct and bystander
killing effects in preclinical studies.
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Our Pipeline of Innovative ADCs
We have self-discovered two Core Products, namely DB-1303/BNT323, a HER2 ADC
candidate targeting cancers including EC and BC, and DB-1311/BNT324, a B7-H3 ADC
candidate targeting cancers including SCLC, CRPC, ESCC and HNSCC. In addition to our
Core Products, we have also self-discovered (i) five other clinical-stage ADCs (namely,
DB-1310, DB-1305/BNT325, DB-1312/BG-C9074, DB-1419 and DB-2304) with potential in
a broad range of indications, each ranking among the most clinically advanced globally in
terms of overall or lead indication development progress, according to Frost & Sullivan; (ii)
two BsADCs (DB-1418/A VZO-1418 and DB-1421) that are expected to enter into clinical
stage from 2025 to 2026; and (iii) multiple other preclinical ADCs. We take a tiered strategy
in ADC development, leading the waves of technology iteration that place us at the forefront
of ADC innovation:
 First batch of assets , enabled by DITAC and serving as proof of concept of our
leading ADC technology, includes (i) ADC candidates with clinically validated
targets strategically developed for differentiated indications, represented by our
Core Product DB-1303, a HER2 ADC, and our key product DB-1305, a TROP2
ADC; and (ii) ADC candidates under global development for high-potential targets
and under-explored indications, represented by our Core Product DB-1311, a B7-H3
ADC, and our key product DB-1310, a HER3 ADC;
 Second batch of assets , leveraging DIBAC and DIMAC, is represented by
next-generation ADCs with novel formats and components that open ADCs to
front-line or difficult-to-treat settings and new therapeutic areas, such as BsADCs,
including DB-1419 (B7-H3xPD-L1 BsADC), DB-1418/A VZO-1418 (EGFRxHER3
BsADC) and DB-1421, and immune-modulating ADCs for autoimmune diseases,
including DB-2304 (BDCA2 ADC), and others; and
 Third batch of assets , enabled by DUPAC, is the driving force behind our novel ADC
payload and linker technologies that potentially disrupt the ADC modality, opening
the possibility to reach hard-to-treat tumors and staying ahead of the growing need
to overcome acquired resistance to existing ADCs.
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The pipeline chart below summarizes the development status of our clinical-stage drug candidates and selected preclinical assets, all of which
are in-house discovered.
N.A.
N.A.
Global
Global
Global
TROP2
OC (2L+) Mono
NCT05438329 Trial completion: 2025
Mainland China,
Hong Kong,
Macau
NSCLC (2L+) Mono
NSCLC, OC, CC, TNBC (multiple lines) +PD-L1xVEGF bsAb
Solid Tumors (CC, TNBC, etc.) Mono
Oncology
HER2
HER2-expressing EC (2L+)
Mono NCT05150691 Trial completion: 2027
Mainland China,
Hong Kong,
Macau
Mono NCT06340568 Trial completion: 2029
HR+/HER2-low BC (chemo naïve) Mono NCT06018337 Trial completion: 2028
HER2+ BC (2L+) Mono NCT06265428 Trial completion: 2026
HER2+ BC (1L) + Pertuzumab
NCT05150691 Trial completion: 2027
Solid Tumors (OC, CRC, esophageal cancer, etc.) Mono
HER3
EGFRm NSCLC (TKI-resistant) + Osimertinib
NCT05785741 Trial completion: 2026 Global
KRASm NSCLC (2L+) Mono
HER2-expressing BC (Post-Enhertu) + Trastuzumab
Solid Tumors Mono
DB-1312
/BG-C9074 B7-H4 Solid Tumors Mono/ + Tislelizumab NCT06233942 Trial completion: 2027 /
DB-1314 Undisclosed Solid Tumors Mono / IND submission: 2026 Global
DB-1317 Undisclosed Solid Tumors Mono / IND submission: 2025 Global
DB-1419 B7-H3 x PD-L1 Solid Tumors Mono NCT06554795 Trial completion: 2027 Global
DB-1418
/AVZO-1418 EGFR x HER3 Solid Tumors Mono / IND submission: 2025 Greater China
DB-1421 Undisclosed Solid Tumors Mono / IND submission: 2026 Global
DB-1316 Undisclosed Solid Tumors Mono / IND submission: 2026 Global
Autoimmune DB-2304 BDCA2 SLE, CLE Mono NCT06625671 Trial completion: 2026 Global
Program Target Indications (lines of treatment) Mono/Combo Preclinical/
IND-Enabling Phase 1 Phase 2a/
Phase 2 Trial LocationPhase 3 NCT Number Upcoming Milestone Commercial Rights Partners
DITAC – Leading TOP1i ADC Platform
DB-1303
/BNT323
DB-1311
/BNT324
DB-1305
/BNT325
DB-1310
B7-H3
SCLC (2L+) Mono
NCT05914116
Mainland China,
Hong Kong,
Macau
(U.S.: Option to
Co-develop and
Co-commercialize)
Mono
ESCC (2L+) Mono
Solid Tumors (HNSCC, HCC, CC, melanoma, etc) Mono
CRPC (late line)
NSCLC (2L+) Mono
/
/
/
/
/
China
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
FDA Fast
Track DesignationCore Products FDA Breakthrough
Therapy DesignationKey Products NMPA Breakthrough
Therapy Designation
FDA Orphan Drug
Designation
Notes:   (1)
(2)
Abbreviations: Mono = Monotherapy, Combo = Combination Therapy, IND = Investigational New Drug, NCT = National Clinical Trial, ADC = Antibody-drug Conjugate, HER2 = Human Epidermal Growth Factor Receptor 2, HER2-expressing = HER2 Status of Tumor Cells Identified with a Test Score of IHC 1+ or Above, EC = Endometrial Cancer, HR+ = Hormone Receptor
Positive, HER2-low=HER2 Status of Tumor Cells Identified with a Test Score of IHC 1+ or IHC 2+/ISH-,  BC = Breast Cancer, Chemo = Chemotherapy, HER2+ = HER2 Status of Tumor Cells Identified with a Test Score of Either IHC 3+ or IHC 2+/ISH+, OC = Ovarian Cancer, CRC = Colorectal Cancer, SCLC = Small Cell Lung Cancer, CRPC = Castration-resistant Prostate
Cancer, ESCC= Esophageal Squamous Cell Carcinoma, NSCLC = Non-small Cell Lung Cancer, HNSCC = Head and Neck Squamous Cell Carcinoma, HCC= Hepatocellular Carcinoma, CC = Cervical Cancer, HER3 = Human Epidermal Growth Factor Receptor 3, EGFRm = EGFR Mutant, TKI = Tyrosine Kinase Inhibitor, KRASm = Kirsten Rat Sarcoma Virus Mutant, BTC =
Biliary Tract Cancer, TROP2 = Human Trophoblast Cell-surface Antigen 2, TNBC = Triple-negative Breast Cancer, PD-L1 = PD-1 Ligand 1, VEGF = Vascular Endothelial Growth Factor, bsAb =  Bispecific Antibody, EGFR = Epidermal Growth Factor Receptor, BDCA2 = Blood Dendritic Cell Antigen 2, MOA = Mechanism of Action, SLE = Systemic Lupus Erythematosus,
CLE = Cutaneous Lupus Erythematosus, FDA = U.S. Food and Drug Administration, NMPA = National Medical Products Administration of the PRC, 1L: first-line treatment, 2L+: second-line or later treatment
For each drug candidate, our clinical development typically begins with a combined phase 1/2a trial, where multiple patient groups across different tumor types or indications are enrolled to assess both safety and efficacy of the drug candidate. Based on the results from these phase 1/2 trials, we determine which indications to prioritize for advancement into later-stage clinical
development. All ongoing clinical trials are subject to regulatory oversight by both the FDA and NMPA, except for DB-1303's phase 3 trial in HER2+ BC patients, which is conducted solely in China and regulated by the NMPA.
BioNTech was the sponsor of this global trial as of the Latest Practicable Date.
BeiGene was serving as the sponsor of this trial as of the Latest Practicable Date.
*
**
**
Single-arm, Potential Registrational Study
Planned Phase 3 Confirmatory Trial
DIBAC – Leading Bispecific ADC Platform
DIMAC – Leading Immune-modulating ADC Platform
DUPAC – Unique Novel MOA Payload ADC Platform
*
Key Regulatory
Authorities
N.A.
N.A.
N.A.
N.A.
N.A.
NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
Trial completion: 2026
/N.A.DB-1324 Undisclosed Solid Tumors Mono Mainland China,
Hong Kong, Macau/
AVENZO
THERAPEUTICS
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Core Products
 DB-1303/BNT323 is a late clinical-stage HER2 ADC candidate with two ongoing
registrational trials (one global trial and one in China) and one potential global
registrational study, with the first indication (HER2-expressing EC) projected to file
for accelerated approval with the FDA as early as 2025. DB-1303 is designed with
a stable, cleavable linker and proprietary topoisomerase-based payload that aim to
lower off-target toxicity and enhance anti-tumor activity, including bystander killing
effects. These features may enable DB-1303 to potentially serve as a new
therapeutic option for patients with HER2-expressing advanced solid tumors,
including both patients with high and low expression levels of HER2. The global
HER2 ADC market is expected to increase from US$4.8 billion in 2023 to US$18.5
billion by 2028, representing a CAGR of 30.8%, according to Frost & Sullivan.
DB-1303 is the most clinically advanced HER2 ADC candidate globally that targets
EC across HER2-expression levels and a candidate in advanced clinical
development for HER2 low-expressing breast cancer (“ BC”), according to Frost &
Sullivan, with potential for extension to other underserved cancer indications.
DB-1303 has obtained Fast Track and Breakthrough Therapy Designations from the
FDA and Breakthrough Therapy Designation from the NMPA for the treatment of
advanced EC in patients who progressed on or after treatment with immune
checkpoint inhibitors, demonstrating DB-1303’s potential to treat advanced EC
patients who currently have low survival rates and a strong medical need for new
and more effective treatments. Moreover, DB-1303’s antitumor activity has been
observed in a range of tumors, including BC, EC, ovarian cancer (“ OC”), colorectal
cancer (“ CRC”) and esophageal cancer, supported by global clinical data from
patients across the U.S., China and Australia to date. To further advance DB-1303,
we formed a global strategic partnership with BioNTech in 2023 to accelerate its
development and maximize its global value.
 DB-1311/BNT324 is a clinically advanced B7-H3 ADC candidate under global
development. B7-H3 is a prominent member of the B7 family that plays a critical
role in promoting tumor progression and metastasis. DB-1311 is designed to harness
the potential of B7-H3 as a therapeutic target, leveraging its widespread
overexpression in a broad range of tumor types, including small-cell lung cancer
(“SCLC ”), non-small cell lung cancer (“ NSCLC ”), BC, castration-resistant prostate
cancer (“ CRPC ”), esophageal squamous cell carcinoma (“ ESCC ”) and head and
neck squamous cell carcinoma (“ HNSCC ”). Notably, DB-1311 demonstrates strong
selectivity by targeting a specific isoform predominantly found on B7-H3-
overexpressing tumor cells, which, combined with its potent payload, stable
linker-payload and fragment crystallizable region silenced (“ Fc-silenced ”) mAb,
potentially translates into a favorable safety profile and a wide therapeutic window.
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In collaboration with BioNTech, we are actively pursuing a comprehensive clinical
development plan to unlock the full potential of DB-1311, both as monotherapy and
in combination with immunotherapy. DB-1311 has shown encouraging antitumor
activity and a manageable safety profile in its ongoing phase 1/2a trial, including in
patients with advanced SCLC, CRPC and multiple other solid tumors. Preliminary
data from this trial were presented in an oral session at the 2024 European Society
of Medical Oncology Asia Annual Meeting (“ ESMO Asia ”). As of September 27,
2024, the data cut-off date for 2024 ESMO Asia, among all evaluable patients with
at least one post-baseline tumor assessment (n=238), the overall unconfirmed ORR
(“uORR ”) was 32.4%, and the DCR was 82.4%. As of the same date, among patients
with SCLC (n=73), the uORR was 56.2%, and the DCR was 89.0%. Among patients
with CRPC (n=32), DB-1311 demonstrated early antitumor activity with a uORR of
28.0% and a DCR of 92.0%; radiographic progression-free survival (“ rPFS ”) data
were not yet mature, with a median rPFS of 7.2 months and a 6-month rPFS rate of
94.7%.
Besides SCLC and CRPC, we are also investigating DB-1311’s treatment potential
in HNSCC, HCC, CC, and melanoma. In 2024, the FDA granted DB-1311 Fast Track
Designation for the treatment of patients with advanced/unresectable, or metastatic
CRPC and Orphan Drug Designations for the treatment of ESCC and SCLC.
Key Products
 DB-1310 is one of the world’s most clinically advanced HER3 ADC candidates,
according to Frost & Sullivan, for which we hold global rights. HER3, along with
EGFR and HER2, are growth factor receptors in the HER family that play crucial
roles in tumor survival and growth. Despite the growing research and clinical
interest in HER3, it remains under-explored and has faced two decades of drug
development challenges due to the complexity in achieving signaling inhibition and
the potential for escape pathway activation. Guided by our team of leading experts
in HER3 research, we have built a deep knowledge base in HER3 biology, including
its dimerization patterns and intricate interactions with EGFR and HER2, and its
involvement in resistance mechanisms. These insights have informed DB-1310’s
innovative design and equipped it with a high internalization capability to deliver
payloads directly into HER3-expressing cancer cells, which leads to targeted tumor
killing and improved therapeutic outcomes.
We believe HER3 ADCs present opportunities to cover a broad patient population
and overcome resistance to standard of care. We have developed a rational and
differentiated clinical development strategy focused on carefully selected
indications that maximize its commercial potential. Building on DB-1310’s
preliminary efficacy observed as a late-line monotherapy for EGFR-mutant
(“EGFRm ”) NSCLC, we have taken a differentiated strategy to investigate its
combination potential with osimertinib in EGFRm NSCLC patients, with
opportunity to be a first-line treatment covering a broader patient population.
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DB-1310 is also one of the few global clinical-stage HER3 ADCs being investigated
as a potential treatment for KRAS-mutant (“ KRASm ”) NSCLC. We are also
exploring the efficacy signals of DB-1310 in various other solid tumors, including
BC, CRPC, HNSCC, ESCC and BTC.
 DB-1305/BNT325 is a TROP2 ADC candidate with a global development strategy.
TROP2, a validated and highly expressed ADC target across a wide spectrum of
cancers, plays a pivotal role in tumor progression. To date, there is only one TROP2
ADC approved globally, indicated for advanced triple-negative breast cancer
(“TNBC ”), urothelial cancer (“ UC”) and HR+/HER2- BC, according to Frost &
Sullivan. The global TROP2 ADC market is expected to increase from US$1.1
billion in 2023 to US$7.7 billion by 2028, representing a CAGR of 48.8%.
DB-1305 targets indications currently under-explored by other TROP2 ADC
candidates, such as OC. DB-1305 also has combination potential as a backbone
therapy in earlier lines of treatment, starting from NSCLC, OC, CC and TNBC. We
believe this well-rounded strategy may position DB-1305 as a potential backbone
therapy in the TROP2 ADC landscape. In collaboration with BioNTech, we are
advancing DB-1305’s global clinical development, including an ongoing phase 1/2a
global trial in patients with advanced solid tumors, where encouraging preliminary
efficacy signals in NSCLC and multiple other solid tumors have been observed.
 DB-1419 is an innovative B7-H3xPD-L1 BsADC candidate with a DNA
topoisomerase I inhibitor, being the only B7-H3xPD-L1 BsADC currently under
clinical development globally, according to Frost & Sullivan. The simultaneous
action of delivering the toxin to tumor cell and modulate T cell activation provides
potential synergistic anti-tumor effect. Combining payload mediated cytotoxicity
with antibody mediated immunotherapy activity, DB-1419 provides an innovative
approach for cancer treatment. We have obtained IND approvals from the FDA and
the NMPA for DB-1419 and we initiated DB-1419’s phase 1/2a global trial in
September 2024.
 DB-2304 is an innovative BDCA2 ADC candidate for systemic lupus erythematosus
(“SLE”) and cutaneous lupus erythematosus (“ CLE”), being one of the most
advanced BDCA2 ADCs in terms of development progress, according to Frost &
Sullivan. DB-2304 offers a selective therapeutic approach specifically targeting the
upstream signaling pathways of SLE/CLE pathogenesis, differentiating it from
existing lupus treatments that often have broader effects on the immune system. We
believe DB-2304 holds promise to substantially improve upon the standard of care
for SLE and CLE, such as glucocorticoids and immunosuppressants, and represents
a major step in the innovation of autoimmune ADCs. We initiated a phase 1 study
in healthy adults for DB-2304 in Australia in October 2024. We have obtained IND
approvals from the FDA and NMPA for DB-2304 and expect to complete DB-2304’s
phase 1 global trial in 2026.
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Our Clinical Development Strategy
We take a differentiated clinical development strategy to accelerate the global expansion
of our drug programs and maximize their impact on patients worldwide, taking into account our
unique features in ADC design, acumen in indication selection and understanding of unmet
clinical needs and the market landscape. Our development strategies are carefully tailored by
drug and target indication, following the general principles below:
 First-to-market approach . To maximize the global competitiveness of our pipeline,
we will select and address initial target indications that are commercially attractive
and often underserved, which enable us to demonstrate key asset differentiation, and
rapidly enter and establish a strong presence in the global market. For example,
DB-1303 is the most clinically advanced HER2 ADC candidate globally that targets
EC across HER2-expression levels, according to Frost & Sullivan. We and
BioNTech have completed patient enrollment for DB-1303’s potential registrational
cohort in HER2-expressing advanced/recurrent EC patients and plan to commence
a confirmatory phase 3 trial in this patient population in 2025.
 Fast-to-commercial approach . Complementing our first-to-market strategy, we
utilize a fast-to-commercial approach to accelerate access to our differentiated
assets for a wider addressable population of patients in need. For instance, DB-1303
is a leading candidate for HER2 low-expressing BC, according to Frost & Sullivan,
with potential for extension to other underserved cancer indications. DB-1303 is
undergoing a phase 3 global registrational trial in HR+/HER2-low metastatic BC
patients who are chemo-naïve (i.e., who have not previously received
chemotherapy) with first patient dosed in January 2024. Furthermore, DB-1311 is
currently one of the top three B7-H3 ADCs undergoing global MRCTs in terms of
clinical development progress for advanced SCLC, according to Frost & Sullivan.
 Combination and indication expansion strategy . We adopt combination therapy
strategies to unlock the frontline and backbone potential for our assets and offer
improved clinical benefits to patients. For instance, DB-1310 is a global clinical-
stage HER3 ADC candidate being developed for EGFRm NSCLC patients resistant
to osimertinib or other third-generation tyrosine kinase inhibitor (“ TKI”) treatments
through combination with osimertinib. Together with BioNTech, we are actively
exploring the combination potential of our Core Products and DB-1305 as a
backbone therapy in early lines of treatment. In June 2024, the first patient was
dosed in a combination cohort of DB-1305’s ongoing phase 1/2a global trial to
evaluate the combination of DB-1305 and BNT327, a bispecific antibody (“ bsAb ”)
targeting PD-L1 and vascular endothelial growth factor (“ VEGF ”), aiming to
harness the potent anti-tumor activity of ADCs along with the sustained benefit of
immunomodulators. In October 2024, we received IND approval from the NMPA to
initiate a phase 1/2a trial for DB-1305 in combination with BNT327 in patients with
late-stage/metastatic solid tumors. Furthermore, DB-1311 is currently undergoing a
phase 1b/2 trial in combination with BNT327, a bsAb targeting PD-L1 and VEGF,
in patients with advanced lung cancer, including SCLC and NSCLC.
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OUR COMPETITIVE STRENGTHS
Key player in the global ADC landscape with insights and strong execution capabilities to
lead ADC innovation
We are a key player in the global ADC landscape, dedicated to the development of
innovative therapeutics in this fast-growing drug modality to treat cancer, autoimmune
diseases, and beyond. ADCs are revolutionizing oncology treatment as the new backbone
therapy, moving towards early-line treatment to replace existing standard of care and
broadening coverage to pan-tumors and pan-expression. Beyond oncology, ADCs hold promise
as the optimal modality in white-space therapeutic areas, such as autoimmune, metabolic and
cardiovascular diseases.
In just four years, we have established four globally innovative ADC technology
platforms, supported by our research, clinical and regulatory insights and execution capability.
We have designed and executed development strategies for our ADC drug candidates to be
competitive with, or differentiated from, those of the leading global ADC players. Leveraging
comprehensive global R&D capabilities, we have seven ongoing global MRCTs across 17
countries and over 230 trial sites, with over 2,000 patients (more than 50% located in the U.S.,
EU, Australia and other regions outside China) enrolled as of the Latest Practicable Date,
including four conducted in collaboration with our strategic partners for which we are currently
acting as the trial sponsor.
With our insights and know-how supported by four leading technology platforms and
strong global clinical development experience, we have accomplished these feats with
industry-leading speed and quality. Our Core Product DB-1303 reached FDA EOP2 meeting in
just 20 months after first-patient-in and is projected to file for accelerated approval with the
FDA within four years after the first patient was dosed. By comparison, the average time for
an innovative drug to advance from IND filing to NDA approval by the FDA is over eight
years, according to Frost & Sullivan. Our ADC candidates have obtained three FDA Fast Track
Designations, two Breakthrough Therapy Designations from the FDA and NMPA, and two
FDA Orphan Drug Designations since our inception. As recognition of the clinical and
commercial value of our platforms and pipeline, we have forged several global partnerships to
date with a total deal value of over US$6.0 billion, enabling us to accelerate the delivery of our
ADC drugs to patients around the world.
We strive to remain at the innovation forefront of this rising modality to unlock its full
potential. Meaningful advancements are being made to enhance and innovate all three ADC
components — the payload, linker and antibody — to improve efficacy and reduce toxicity, and
potentially extend ADCs to front-line or difficult-to-treat settings, including relapsed patients
with drug resistance to current standard-of-care treatments. In addition to cancer treatment,
innovative ADCs are also being developed for a broader spectrum of non-oncology indications.
Driven by continued innovation, the global ADC market is expected to surpass US$110 billion
by 2032. In the pursuit of next-generation ADCs, China has emerged as a global innovation
center, where over 45% of the world’s clinical trials conducted for ADCs since 2023 took place.
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With growing global competency in drug discovery, biotech companies in China are leading the
research of novel targets such as HER3 and B7-H3 and new modalities like BsADCs, achieving
a record-breaking US$35 billion in ADC deals with global MNCs since 2022. Guided by our
“CP
2” formula, we aim to continue to achieve breakthroughs in ADC technology and drug
development that propel us to the forefront of the industry.
Clinically advanced ADC assets with promising global data as validation of our DITAC
platform
We have developed a pipeline of novel ADCs led by seven clinical-stage assets each
ranking among the most clinically advanced globally in terms of overall or lead indication
development progress, according to Frost & Sullivan. These assets leverage both well-
validated targets, such as HER2 and TROP2, and emerging targets, such as B7-H3 and HER3,
with broad indication opportunities. As we rapidly advance these assets towards regulatory
approval and commercialization, we have established a global leading position in addressable
markets with vast clinical and commercial potential.
Our clinical-stage assets have shared roots in DITAC, our proprietary topoisomerase-
based ADC platform. DITAC is validated by the global clinical data from over 2,000 patients
across the U.S., China, Europe, Australia and other major markets. Compared to ADCs with
earlier-generation payloads such as monomethyl auristatin E (“ MMAE ”), topoisomerase-based
ADCs are distinguished for their ability to target a broader range of tumor types. Notably, the
bystander effect of topoisomerase-based ADCs enhances efficacy by allowing the cytotoxic
payload to affect neighboring tumor cells that may not express the target antigen.
DITAC takes a holistic approach to ADC design, demonstrating improved systemic
stability, tumor-specific payload release, bystander-killing effects, and rapid payload
clearance, which potentially translates to a significantly improved therapeutic window. We
have developed a library of proprietary linkers and payloads with meaningful technological
improvements, giving us critical optionality in optimizing each ADC component for a broad
range of target indications.
DB-1303/BNT323, a late clinical-stage HER2 ADC candidate, our Core Product
Our Core Product DB-1303 is a late clinical-stage HER2 ADC candidate with two
ongoing registrational trials (one global trial and one in China) and one potential global
registrational study, with the first indication (HER2-expressing EC) projected to file for
accelerated approval with the FDA as early as 2025. DB-1303 is designed with a stable,
cleavable linker and proprietary topoisomerase-based payload that aim to lower off-target
toxicity and enhance anti-tumor activity, including bystander killing effects. These features
may enable DB-1303 to potentially serve as a new therapeutic option for patients with
HER2-expressing advanced solid tumors, including both patients with high and low expression
levels of HER2. The global HER2 ADC market is expected to increase from US$4.8 billion in
2023 to US$18.5 billion by 2028, representing a CAGR of 30.8%, according to Frost &
Sullivan.
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DB-1303 is the most clinically advanced HER2 ADC candidate globally that targets EC
across HER2-expression levels and a candidate in advanced clinical development for HER2
low-expressing BC, according to Frost & Sullivan, with potential for extension to other
underserved cancer indications. DB-1303 has obtained Fast Track and Breakthrough Therapy
Designations from the FDA and Breakthrough Therapy Designation from the NMPA for the
treatment of advanced EC in patients who progressed on or after treatment with immune
checkpoint inhibitors, demonstrating DB-1303’s potential to treat advanced EC patients who
currently have low survival rates and a strong medical need for new and more effective
treatments. Moreover, DB-1303’s antitumor activity has been observed in a range of tumors,
including BC, EC, OC, CRC and esophageal cancer, supported by global clinical data from
patients across the U.S., China and Australia to date. To further advance DB-1303, we formed
a global strategic partnership with BioNTech in 2023 to accelerate its development and
maximize its global value.
Highlights of DB-1303 include:
 Most clinically advanced HER2 ADC globally for EC patients across HER2-
expression levels . EC is known to be one of the most common gynecological
malignancies globally, with approximately 400,000 new cases reported worldwide in
2023, according to Frost & Sullivan. Approved first- and second-line standard-of-
care treatments for EC, including chemotherapy and targeted therapies, have shown
limited efficacy in advanced or metastatic EC patients, highlighting an unmet
medical need.
We aim to improve treatment for EC patients across HER2-expression levels.
DB-1303 is differentiated by observed anti-tumor activity across both HER2-low
(IHC 1+ and IHC 2+) and HER2+ EC patients, which potentially expands its
suitability to over 70% of the EC patient population. Notably, DB-1303
demonstrated an overall objective response rate (“ ORR”) of 58.8% and disease
control rate (“ DCR”) of 94.1% in heavily pre-treated HER2-expressing EC patients
(IHC 1/2/3+ or ISH-positive), including those with prior immunotherapy or
anti-HER2 antibody treatments, in its phase 1/2a trial, preliminary data of which
were published at the 2023 European Society of Gynaecological Oncology Congress
(“ESGO ”). We and BioNTech have completed patient enrollment for DB-1303’s
potential registrational cohort in HER2-expressing advanced/recurrent EC patients
and plan to commence a confirmatory phase 3 trial in this patient population in
2025.
 Potential treatment for chemo-naïve HR+/HER2-low BC patients . BC is known to
be the second largest cancer type in the world by incidence, according to Frost &
Sullivan, with approximately 2.4 million new cases reported in 2023 of which
HR+/HER2-low patients accounted for approximately 50%. According to Frost &
Sullivan, the only HER2 ADC approved for HER2-low BC to date is currently
indicated for patients who have received a prior chemotherapy in the metastatic
setting or developed disease recurrence during or within six months of completing
adjuvant chemotherapy. We are advancing, in collaboration with BioNTech, a phase
3 global registrational trial for DB-1303 in chemo-naïve HR+/HER2-low metastatic
BC patients with first patient dosed in January 2024.
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 Phase 3 topoisomerase-based ADC for HER2+ BC in China . About 15-30% of BC
patients are HER2+, with a significant patient population of approximately 92.7
thousand in China in 2023, according to Frost & Sullivan. Despite the potential of
topoisomerase-based ADCs to offer significantly improved progression-free
survival and overall survival compared to existing treatments, there is only one
topoisomerase-based HER2 ADC approved in China to date. We plan to complete
our phase 3 registrational trial in China in 2026 for DB-1303 versus T-DM1
(trastuzumab emtansine) in patients with HER2+ unresectable and/or metastatic BC
previously treated with trastuzumab and taxane and file biologics license application
(“BLA”) with the NMPA by the end of 2025.
 Promising efficacy and manageable safety data in phase 1/2a global trial . DB-1303
demonstrated encouraging efficacy results in its phase 1/2a global trial, based on
preliminary data as of January 13, 2023 published at the 2023 American Society of
Clinical Oncology Annual Meeting (“ ASCO ”). The uORR and DCR across all dose
levels was 44.2% and 88.5%, respectively, in patients with HER2-expressing solid
tumors with a median of seven previous lines of treatment, including prior HER2
ADC regimens, as of January 13, 2023. In addition, preliminary antitumor activity
has also been observed in other tumor types, including OC, CRC and esophageal
cancer, signifying DB-1303’s potential for indication expansion. DB-1303 was
well-tolerated with no dose-limiting toxicity (“ DLT”) observed in all six dose levels
(ranging from 2.2 mg/kg to 10 mg/kg) during dose escalation and no treatment-
emergent adverse event (“ TEAEs ”) associated with death in phase 1/2a global trial
as of January 13, 2023.
DB-1311/BNT324, a B7-H3 ADC candidate with global market potential, our Core Product
DB-1311 is a clinically advanced B7-H3 ADC candidate under global development.
B7-H3 is a prominent member of the B7 family that plays a critical role in promoting tumor
progression and metastasis. DB-1311 is designed to harness the potential of B7-H3 as a
therapeutic target, leveraging its widespread overexpression in a broad range of tumor types,
including SCLC, NSCLC, CRPC, ESCC and HNSCC. Notably, DB-1311 demonstrates strong
selectivity by targeting a specific isoform predominantly found on B7-H3-overexpressing
tumor cells, which, combined with its potent payload, stable linker-payload and Fc-silenced
mAb, potentially translates into a favorable safety profile and a wide therapeutic window.
In collaboration with BioNTech, we are actively pursuing a comprehensive clinical
development plan to unlock the full potential of DB-1311, both as monotherapy and in
combination with immunotherapy. DB-1311 has shown encouraging antitumor activity and a
manageable safety profile in its ongoing phase 1/2a trial, including in patients with advanced
SCLC, CRPC and multiple other solid tumors. Besides SCLC and CRPC, we are also
investigating DB-1311’s treatment potential in HNSCC, HCC, CC, and melanoma. In 2024, the
FDA granted DB-1311 Fast Track Designation for the treatment of patients with
advanced/unresectable, or metastatic CRPC and Orphan Drug Designations for the treatment of
ESCC and SCLC.
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Highlights of DB-1311 include:
 Key player in the global B7-H3 ADC landscape . Despite the current absence of
approved B7-H3-targeted therapies, B7-H3 ADCs have demonstrated encouraging
clinical efficacy, notably in SCLC patients, sparking substantial interest and
high-profile licensing deals in the field, according to Frost & Sullivan. DB-1311 is
currently one of the top three B7-H3 ADCs undergoing global MRCTs in terms of
clinical development progress for advanced SCLC, according to Frost & Sullivan.
SCLC is an aggressive form of lung cancer characterized by rapid growth and high
rates of recurrence. We are also investigating DB-1311’s potential in treating CRPC
patients, another cancer population that is highly underserved. To date, there are no
B7-H3 ADC candidates indicated for CRPC that have entered into phase 3
registrational trial worldwide, according to Frost & Sullivan.
 Novel design with the potential to enable tumor killing and wide therapeutic
window . DB-1311 is designed to deliver potent tumor killing while reducing
off-target toxicities. Conjugated at a higher drug-to-antibody ratio (“ DAR”) value of
6, DB-1311 showed more potent antitumor activity compared to DS-7300 in vitro
and in vivo in both high and medium B7-H3 expression models, based on preclinical
results published at the 2023 American Association for Cancer Research (“ AACR ”)
Annual Meeting. DB-1311 demonstrated high selectivity by targeting the 4IgB7-H3
isoform, which is predominantly found on B7-H3-overexpressing tumor cells, with
over 1,000-fold greater affinity compared to the 2IgB7-H3 isoform commonly
expressed on normal cells. This high selectivity differentiates DB-1311 and aims to
enable the delivery of DB-1311’s payload directly into tumor cells. Meanwhile,
DB-1311’s Fc-silenced mAb is designed to reduce unwanted immune responses. In
preclinical studies, DB-1311 has shown a significantly highest non-severely toxic
dose (“ HNSTD ”) and better binding to B7-H3-expressing lung cancer cells
compared to DS-7300.
 Promising clinical efficacy and manageable safety profile observed in phase 1/2a
trial . DB-1311 showed encouraging antitumor activity in its phase 1/2a global trial
in advanced solid tumors. Preliminary data from this trial were presented in an oral
session at 2024 ESMO Asia. As of September 27, 2024, the data cut-off date for
2024 ESMO Asia, among all evaluable patients with at least one post-baseline tumor
assessment (n=238), the overall uORR was 32.4%, and the DCR was 82.4%. As of
the same date, among patients with SCLC (n=73), the uORR was 56.2%, and the
DCR was 89.0%. Among patients with CRPC (n=32), DB-1311 demonstrated early
antitumor activity with a uORR of 28.0% and a DCR of 92.0%; rPFS data were not
yet mature, with a median rPFS of 7.2 months and a 6-month rPFS rate of 94.7%.
We are also investigating DB-1311’s treatment potential in several prevalent cancer
types under-explored by other clinical-stage B7-H3 ADCs. Preliminary data from
DB-1311’s phase 1/2a global trial also showed an acceptable and manageable safety
profile, with low rates of treatment-related adverse events (“ TRAEs ”) associated
with drug discontinuation, dose reduction, drug interruption or death.
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 Combination potential as frontline treatment for prevalent cancers . We believe the
combination of DB-1311 with immunotherapy holds therapeutic promise, as the
direct cytotoxic effects of this B7-H3 ADC synergize with the immune-activating
properties of immunotherapies, potentially leading to a more powerful anti-tumor
response and improved patient outcomes. We are actively exploring DB-1311’s
combination potential to expand into earlier treatment lines in various solid tumors,
such as CRPC, SCLC and NSCLC. For example, DB-1311 is currently undergoing
a phase 1b/2 trial in combination with BNT327, a bsAb targeting PD-L1 and VEGF,
in patients with advanced lung cancer, including SCLC and NSCLC.
 Opt-in rights to co-develop and co-commercialize in the U.S . Under our
collaboration agreement with BioNTech, we have retained an option to co-develop
and co-commercialize DB-1311 in the U.S. If we elect to exercise this option, we
will become eligible to share the profits/losses and costs from DB-1311’s
development and commercialization in this major market. This strategic partnership
not only demonstrates our confidence in and commitment to DB-1311’s global
development, but also allows us to leverage BioNTech’s complementary strengths
and resources while capturing the asset’s significant economic interest and upside
potential overseas. As such, we are well-positioned to efficiently navigate the
complex global market landscape and accelerate DB-1311’s entry into both domestic
and international markets.
DB-1310, a HER3 ADC candidate in phase 1/2a trial, our key product
DB-1310 is one of the world’s most clinically advanced HER3 ADC candidates,
according to Frost & Sullivan, for which we hold global rights. HER3, along with EGFR and
HER2, are growth factor receptors in the HER family that play crucial roles in tumor survival
and growth. Despite the growing research and clinical interest in HER3, it remains
under-explored and has faced two decades of drug development challenges due to the
complexity in achieving signaling inhibition and the potential for escape pathway activation.
Guided by our team of leading experts in HER3 research, we have built a deep knowledge base
in HER3 biology, including its dimerization patterns and intricate interactions with EGFR and
HER2, and its involvement in resistance mechanisms. These insights have informed DB-1310’s
innovative design and equipped it with a high internalization capability to deliver payloads
directly into HER3-expressing cancer cells, which leads to targeted tumor killing and improved
therapeutic outcomes.
We believe HER3 ADCs present opportunities to cover a broad patient population and
overcome resistance to standard of care. We have developed a rational and differentiated
clinical development strategy focused on carefully selected indications that maximize its
commercial potential. Building on DB-1310’s preliminary efficacy observed as a late-line
monotherapy for EGFRm NSCLC, we have taken a differentiated strategy to investigate its
combination potential with osimertinib in EGFRm NSCLC patients, with opportunity as
first-line treatment to cover a broader patient population. DB-1310 is also one of the few global
clinical-stage HER3 ADCs being investigated as a potential treatment for KRASm NSCLC. We
are also exploring the efficacy signals of DB-1310 in various other solid tumors, including BC,
CRPC, HNSCC, ESCC and BTC.
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Highlights of DB-1310 include:
 Differentiated EGFRm NSCLC strategy . DB-1310 is a global clinical-stage HER3
ADC candidate being developed for EGFRm NSCLC patients resistant to
osimertinib or other third-generation TKI treatments, according to Frost & Sullivan.
DB-1310 demonstrated promising anti-tumor activity as a single agent in patients
with advanced or metastatic EGFRm NSCLC who failed previous standard therapies
in the dose escalation cohort of its phase 1/2a clinical trial. We are also developing
DB-1310 in combination with osimertinib based on our translational medicine
research that EGFR inhibition synergistically promotes HER3 ADC internalization
and efficacy. We are enrolling patients in our phase 1 global dose escalation study
for DB-1310 in China and the U.S.
 Unique coverage of KRASm NSCLC . KRAS mutations are estimated to occur in
approximately 30% of NSCLC cases. There are currently no global registrational
trials for HER3 ADC candidates specifically targeting KRASm NSCLC,
highlighting the potential of DB-1310 in this underserved area. Patients with
KRASm NSCLC typically experience rapid disease progression after KRAS TKI
treatments, and those who develop drug resistance face severely limited subsequent
treatment options. We have observed preliminary efficacy in KRASm NSCLC
patients, including partial response in dose expansion, in DB-1310’s phase 1/2a
global trial.
 Encouraging efficacy in multiple BC subtypes . DB-1310 has demonstrated efficacy
signals as a single agent across multiple BC subtypes, including for HER2+ BC and
HR+/HER2-low BC, and in TNBC patients with prior Trodelvy
® treatment.
Furthermore, DB-1310 in combination with trastuzumab has significant potential to
treat HER2-expressing BC patients with prior Enhertu
® treatment, given HER3’s
critical role in drug resistance and pathway synergies with HER2.
 Treatment potential for CRPC . HER3 protein is frequently overexpressed in prostate
cancer, correlating with faster progression to castration resistance and reduced
overall survival. In preclinical studies, DB-1310 has demonstrated significant
antitumor activity against prostate cancer, indicating its potential as a promising
treatment for this cancer type. We are currently recruiting patients with CRPC in
DB-1310’s phase 1/2a trial.
 Promising preliminary data from phase 1/2a trial . DB-1310 demonstrated promising
anti-tumor activity as a single agent in patients with advanced or metastatic EGFRm
NSCLC who failed previous standard therapies in the dose escalation cohort of its
phase 1/2a clinical trial. In EGFRm NSCLC patients, as of May 17, 2024, uORR and
DCR reached 39% and 94.4%, respectively, across dose levels from 1.5 to 5.5
mg/kg. The uORR and DCR was 50% and 100% at 4.5 mg/kg, respectively, and
100% and 100% at 5.5 mg/kg, respectively. DB-1310 also demonstrated an
acceptable and manageable safety profile in its phase 1/2a global trial. As of May
17, 2024, the incidence of grade 3 or above TRAEs was 19.3%.
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DB-1305/BNT325, a TROP2 ADC candidate with potential as a frontline backbone therapy,
our key product
DB-1305 is a TROP2 ADC candidate with a global development strategy. TROP2, a
validated and highly expressed ADC target across a wide spectrum of cancers, plays a pivotal
role in tumor progression. To date, there is only one TROP2 ADC approved globally, indicated
for advanced TNBC, UC and HR+/HER2- BC, according to Frost & Sullivan. The global
TROP2 ADC market is expected to increase from US$1.1 billion in 2023 to US$7.7 billion by
2028, representing a CAGR of 48.8%.
DB-1305 targets indications currently under-explored by other TROP2 ADC candidates,
such as OC. DB-1305 also has combination potential as a backbone therapy in earlier lines of
treatment, starting from NSCLC, OC, CC and TNBC. We believe this well-rounded strategy
may position DB-1305 as a potential backbone therapy in the TROP2 ADC landscape. In
collaboration with BioNTech, we are advancing DB-1305’s global clinical development,
including an ongoing phase 1/2a global trial in patients with advanced solid tumors, where
encouraging preliminary efficacy signals in NSCLC and multiple other solid tumors have been
observed.
Highlights of DB-1305 include:
 Well-positioned to address underserved needs in OC treatment . Despite the
encouraging therapeutic benefits shown by TROP2 ADCs, the global clinical
development of TROP2 ADCs is currently heavily focused on TNBC, HR+/HER2-
BC, UC and NSCLC. Because TROP2 is a significant prognostic biomarker and
therapeutic target across other prevalent or hard-to-treat cancers, this leaves unmet
needs among patients. OC, for example, is one of the leading causes of cancer death
in women globally with over 300,000 diagnosed each year.
Traditionally, ADC development has focused on FR /H9251-positive OC patients, who
constitute a limited subset of the OC population. Compared to FR /H9251-directed ADCs,
DB-1305 demonstrates broader treatment potential among a wide range of OC
patients, due to TROP2’s high overexpression rate (~83%) in this cancer type. In
January 2024, DB-1305 was granted Fast Track Designation by the FDA for patients
with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal
cancer, acknowledging its potential to address unmet medical needs.
 Combination potential as backbone therapy in multiple solid tumors . We and
BioNTech are actively exploring DB-1305’s combination potential as a backbone
therapy in early lines of treatment, starting from NSCLC, OC, cervical cancer
(“CC”) and TNBC. In June 2024, the first patient was dosed in a combination cohort
of DB-1305’s ongoing phase 1/2a global trial to evaluate the combination of
DB-1305 and BNT327, a bsAb targeting PD-L1 and VEGF, aiming to harness the
potent anti-tumor activity of ADCs along with the sustained benefit of
immunomodulators. In October 2024, we received IND approval from the NMPA to
initiate a phase 1/2a trial for DB-1305 in combination with BNT327 in patients with
late-stage/metastatic solid tumors.
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 Encouraging efficacy and manageable safety profile from phase 1/2a trial . Based on
preliminary data from DB-1305’s ongoing phase 1/2a global trial, which were
published at the 2023 European Society for Medical Oncology Congress (“ ESMO ”),
DB-1305’s uORR was 30.4% and unconfirmed DCR was 87.0% among heavily
pretreated patients with advanced solid tumors as of April 7, 2023. Among the 23
patients with post-baseline tumor scans, encouraging preliminary efficacy signals
were observed in NSCLC patients: uORR was 46.2% and unconfirmed DCR was
92.3%. Encouraging preliminary efficacy signals of DB-1305 have also been
observed in multiple other solid tumors. Based on preliminary data from its phase
1/2a global trial, DB-1305 was well-tolerated and all TEAEs were generally
manageable at lower dose levels, with grade 3 or above TRAEs reported at 34.1%
(15/44) in all patients and low incidences of blood-related TRAEs.
Innovator in ADC development powered by versatile platforms to target underserved
therapeutic areas
We push the boundaries of ADC innovation through continued development and iteration
of three cutting-edge technology platforms, DIBAC, DIMAC and DUPAC. Based on the
successful development of our DITAC platform, we have built each of DIBAC, DIMAC and
DUPAC upon our accumulated antibody engineering, linker chemistry and toxin technologies
and know-how, as well as our deep disease biology and target insights. These platforms are
tailored to explore next generation ADC formats, mechanism of action, and diseases within and
beyond the realm of cancer.
Our technology platforms serve as the foundation for continuous and sustained innovation
and value creation, driving our cutting-edge R&D and strategic collaborations with global
partners. In addition to our clinical-stage assets, we are advancing multiple preclinical
programs, including five expected to initiate clinical trials by the end of 2026.
DIBAC — Next-generation BsADC platform
BsADCs are next-generation therapeutics that combine the targeting precision of bsAbs
with the potent cytotoxicity of ADCs. By incorporating two distinct binding moieties in a
single therapeutic entity, BsADCs can potentially offer meaningful advantages over traditional
monospecific ADCs and their combination therapies.
While promising, the complexity of BsADCs introduces new challenges in antibody
engineering, stability and manufacturing. Our innovative DIBAC platform features our
understanding of disease and target biology, rich experience in bispecific antibody engineering,
and artificial intelligence-enabled target selection and antibody design.
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Our DIBAC platform features proprietary design strategies under two approaches:
 Synergistic tumor-associated antigen (“ TAA”) + IO approach. We have designed
BsADCs with dual function antibodies that enhance anti-tumor effect by
simultaneously targeting (i) TAA on tumor cells to induce tumor cell death, and (ii)
IO antigen to harness the immune system for more potent and lasting anti-tumor
activity. We believe this presents a novel and promising approach to cancer
treatment.
DB-1419, an innovative B7-H3xPD-L1 BsADC candidate, being the only B7-
H3xPD-L1 BsADC currently under clinical development globally, according to
Frost & Sullivan, is a representative TAA+IO asset. We believe B7-H3’s pan-cancer
expression coupled with PD-L1’s immune-modulating function may offer enhanced
anti-tumor effects across broad indications. Preclinical studies showed that DB-1419
exhibits both direct cancer cell killing and immune-modulation, with more potent
tumor growth inhibition activity than the monospecific B7-H3 ADC and the
monospecific B7-H3 ADC in combination with a PD-L1 mAb in immune
reconstitute models. Moreover, it was well tolerated with repeat dose administration
up to 120 mg/kg in monkeys. We have obtained IND approvals from the FDA and
the NMPA for DB-1419 and we initiated DB-1419’s phase 1/2a global trial in
September 2024.
 Dual-TAA approach. Due to tumor heterogeneity, monospecific antigen targeting
often has suboptimal therapeutic outcomes. Under this approach, we design BsADCs
that target two distinct and optimally selected TAAs co-expressed on the same
cancer cells to improve binding specificity toward cancer cells and reduce off-tumor
toxicity.
DB-1418, a EGFRxHER3 BsADC, is a representative asset of this approach. Due to
target synergies, EGFRxHER3 BsADCs have demonstrated enhanced efficacy and
ability to overcome resistance to EGFR-directed treatments in clinical studies. Our
DB-1418 is differentiated by a “1+1” format molecule design (two binding sites, one
for each target) that translates to higher binding capacity to tumor cells as opposed
to healthy cells. DB-1418 has also shown better efficacy in EGFR-resistant or
EGFR-low models compared to BsADCs with a “2+2” design, potentially covering
a broad patient population currently under-served. We are conducting IND-enabling
studies for DB-1418 and expect to advance this molecule into clinical stage in the
first half of 2025.
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DIMAC — Next-generation Immune-modulating ADC platform
We believe immune-modulating ADCs hold the potential to open the ADC modality to a
significant white-space market in autoimmune and other therapeutic areas. Many patients with
chronic autoimmune diseases, such as SLE and CLE, are currently treated with therapies that
often lead to severe side effects. Long term use of glucocorticoids, for example, are commonly
associated with increased risks of bone fractures, weight gain, diabetes, immune system
suppression, and other chronic conditions. We believe ADCs can reshape the treatment
paradigm of autoimmune diseases by offering a targeted treatment with low systemic exposure,
enhanced efficacy and reduced side effects. Immune-modulating ADCs have been validated by
preliminary clinical data from peers, showing better safety and efficacy profiles compared to
the antibody alone.
We are a global pioneer in this space with the ability to mobilize our accumulated
technology in oncology into innovation of autoimmune ADCs, according to Frost & Sullivan.
Leveraging our technology accumulation in target and payload selection and ADC design, our
DIMAC platform has demonstrated broad anti-inflammatory activity, long duration of action,
sustained stability, and low systemic exposure in preclinical studies. We have developed a deep
technological moat for DIMAC with patent protection extending beyond 2040.
DB-2304 , the representative asset for our DIMAC platform, is an innovative BDCA2
ADC candidate for SLE and CLE. SLE and CLE are autoimmune diseases that together affect
over eight million patients globally, being one of the most advanced BDCA2 ADCs in terms
of development progress. A major shortcoming of mainstay treatments, such as glucocorticoids
and immunosuppressants, is their inability to address the high heterogeneity of pathogenesis in
these complex diseases, which often result in limited efficacy and serious side effects,
especially when used long term for chronic disease management.
We designed DB-2304 with a novel BDCA2 mAb conjugated with a proprietary
glucocorticoid receptor (“ GR”) agonist as a payload. BDCA2 is a validated target that is
specifically expressed on plasmacytoid dendritic cells (“ pDCs ”), whose over-production of
type I interferon (“ IFN-I ”) is crucial in SLE and CLE pathogenesis. Although BDCA2-targeted
mAbs have demonstrated reduced disease activity in SLE patients, their clinical efficacy is
generally limited. By selectively targeting BDCA2, DB-2304 can deliver the immune-
modulating payload directly to pDCs, which has demonstrated greater potency with synergistic
effects in suppressing production of IFN-I as well as other pro-inflammatory cytokines in
preclinical studies. Moreover, by delivering the GR agonist in a site-specific manner, DB-2304
showed good drug stability and serum stability, as well as a promising safety profile with a no
observed adverse effect level (“ NOAEL ”) of 85 mg/kg in monkeys.
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DUPAC — Unique Novel MOA payload ADC platform
We are looking ahead to the next innovation to disrupt the ADC landscape. We anticipate
a growing need for ADC payloads with a novel mechanism of action as more patients develop
resistance to existing ADCs. Moreover, we believe ADCs with new mechanism of action are
the future direction in combating hard-to-treat tumors out of the reach of existing ADCs.
We are building DUPAC to develop linker-payload complexes with novel mechanisms of
action (“ MOA”) beyond traditional cytotoxic agents to combat growing drug resistance and
hard-to-treat tumors. We have made promising progress in a number of unique payload
mechanisms and have obtained prototypes with broad-spectrum anti-tumor activity across
multiple solid tumors, and potent direct and bystander killing effects in preclinical studies. In
particular, our in-house discovered lead prototype has a unique MOA that demonstrates
broad-spectrum anti-tumor activity across multiple solid tumors and remains potent in tumors
resistant to deruxtecan. ADCs designed with our lead prototype have also shown potent direct
and bystander killing effects and induce strong immunogenic cell death.
Strategic and value-enhancing partnerships to sustain long-term global development
We have set our sights on being a global leader in ADC innovation from day one. In line
with our global strategy, we have established an array of strategic partnerships to accelerate the
development of our pipeline across key global markets, expand our global clinical development
capabilities, and fuel our future innovation and long-term growth. In our short operating
history, we have entered into several out-licensing and collaboration deals with leading
industry players worldwide to date, including BioNTech, BeiGene, Adcendo, GSK, and
Avenzo, with over US$6.0 billion in total deal value (of which approximately US$500 million
had been received as of the Latest Practicable Date). We believe our proven partnership model
has the following advantages:
 V alidation of industry-leading innovation . Our high-profile partnerships served as
industry validation of our platform technologies and pipeline assets. Since deal
signing, through the consistent and timely achievement of R&D and clinical
milestones, we have solidified and deepened our collaboration with our partners. We
believe our partnerships have elevated our strengths, especially in executing global
trials and managing multicenter studies, hence expanding our cross-border clinical
development capabilities. Our partnerships have also enabled our exploration into
new R&D programs. With our established reputation, we strive to become a
partner-of-choice for global biopharmaceutical companies seeking innovative ADC
programs.
 Strong commercial upside . We had received approximately US$500 million in
upfront and milestone payments from collaboration partners as of the Latest
Practicable Date, providing significant capital support for our R&D and operations.
In addition, we have structured our partnerships favorably to provide strong
commercial upside and visibility. For example, we have preserved the opportunity
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to capture the commercial upside of DB-1311 by retaining the opt-in rights to
co-develop and co-commercialize this asset with BioNTech in the U.S. As part of
our partnership with Adcendo, we also have an exclusive option to license the
Greater China rights for the development and commercialization of Adcendo’s novel
ADC candidates arising from this collaboration, after such assets have completed
proof-of-concept trials.
 Fueling future innovation . The replicability of our partnership model delineates a
sustainable path for future innovation. Cash flows generated from our partnerships
contribute to our agile pipeline development strategy, sustaining our R&D engine to
deliver more cutting-edge technologies and assets. Through external collaboration,
we create flexible deal structures to allow our partners and us to leverage each
other’s strengths to accelerate the development of drug candidates that are valued by
patients and the biopharmaceutical industry. We believe our partnership model
creates a virtuous business cycle that will drive our long-term value creation and
generate future partnership opportunities.
World-class management team of ADC experts and seasoned entrepreneurs with a proven
track record
We are a dynamic and driven ADC company that values quality, efficiency and speed.
Within just four years since our inception, seven of our ADC candidates have advanced from
program initiation to IND approval. In addition, we have seven ongoing global MRCTs,
including two registrational trials (one global trial and one in China) and one potential global
registrational study.
We owe these successes to our leadership team, who guides our strategic direction. We
believe their complementary expertise across R&D, clinical execution and entrepreneurship
have been the pillars of our success:
 Dr. ZHU Zhongyuan , MBA, Ph.D., our founder, chairman of the Board and chief
executive officer, is a key figure in the biotech landscape with a unique background
in both the scientific and business facets of the industry. Dr. Zhu brings strong
business acumen, industry insights, and over 20 years of experience in
pharmaceutical entrepreneurship and investment as a former partner at leading
venture capital firms such as 6 Dimensions Capital and Wuxi Healthcare V entures.
Dr. Zhu has consistently demonstrated his ability to navigate market dynamics and
make investment decisions that drive innovation and value creation, playing a
significant role in the incubation and growth of several notable biotechnology
companies, including CStone Pharmaceuticals (HKEX: 2616), RemeGen Co., Ltd.
(HKEX: 9995), Gan & Lee Pharmaceuticals (SHA: 603087), and BGI Genomics
Co., Ltd. (SHE: 300676). With a Ph.D. from the University of Massachusetts at
Worcester in biomedical science and an MBA from the University of California at
Berkeley, Dr. Zhu combines his scientific background with entrepreneurial judgment
and foresight, guiding our Company to capitalize on opportunities, forge strategic
partnerships worldwide, and remain at the forefront of ADC development.
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 Dr. QIU Yang , Ph.D., our chief scientific officer, drives the scientific direction of
our pipeline programs, with over two decades of experience in drug discovery and
translational medicine at MNCs. Prior to joining us, Dr. Qiu served as co-chair of
the cross-functional ADC forum and senior director of translational medicine at
Daiichi Sankyo, where she was a leading contributor to the development of
innovative ADC therapy, most notably HER3-DXd (U3-1402, patritumab
deruxtecan), which received FDA Breakthrough Therapy Designation in 2021.
Before Daiichi Sankyo, Dr. Qiu held key positions as director and head of biomarker
research at Janssen China Discovery Center and director leading the progress of
early drug discovery at GSK R&D China. Throughout her distinguished career, Dr.
Qiu has demonstrated success in leading drug discovery, translational medicine, and
early clinical development programs, contributing to the discovery and advancement
of over 15 drug candidates into clinical trials and the approval of multiple
innovative drugs. Dr. Qiu’s understanding of the ADC landscape and track record
are foundational to our continued success as we develop cutting-edge ADC
technologies that transform patient care.
 Dr. MU Hua , Ph.D., our global chief medical officer, leads our global clinical
development team and oversees our clinical development strategies. With decades of
global experience in pharmaceutical research, translational medicine and clinical
development, Dr. Mu held leadership roles at renowned MNCs, biopharmaceutical
companies and investment firms, including Genentech, Inc., WuXi AppTec Co., Ltd.
(HKEX: 2359), and Simcere Pharmaceutical Group Limited (HKEX: 2096) or their
respective subsidiaries. Prior to joining us, Dr. Mu served as chief executive officer,
interim chief medical officer and China head at Zenas BioPharma Inc. (Nasdaq:
ZBIO). His extensive experience as a seasoned biotechnology executive and drug
developer provides strategic vision for us to advance efficient clinical development
programs and navigate regulatory landscapes.
 Ms. GU Wei , M.D., our chief medical officer, brings over ten years of expertise in
clinical development across the globe, highlighted by her extensive experience
leading numerous clinical studies. Ms. Gu has built a successful track record for
clinical development at renowned MNCs, including Boehringer Ingelheim,
AstraZeneca, and Bristol Myers Squibb, and her strategic oversight plays a key role
in our efficient trial execution and alignment with regulatory standards. Earlier in
her career, Ms. Gu had six years of physician experience at a top-grade hospital in
China.
 Mr. WANG Xin , CFA, is our chief business officer. Mr. Wang is a seasoned
executive with nearly 20 years’ industry experience. Before joining us, he was
responsible for research on the global healthcare sector and advising corporate
clients on business strategy and development at Mizuho Bank in New Y ork. Before
that, Mr. Wang was a member of the top-ranked pharmaceutical research teams at
UBS. Earlier in his career, Mr. Wang worked at the pharmaceutical R&D team at
Schering-Plough Research Institute (now Merck).
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 Dr. HUA Haiqing , Ph.D., our senior vice president and head of drug discovery, leads
our strategies for novel drug discovery and CMC development. Over the past 15
years, Dr. Hua has established a strong track record of leading the discovery of
innovative drugs and advancing them into the clinic. Prior to joining us, Dr. Hua
held senior positions at Hansoh Pharma and as a principal scientist at Lilly China
R&D Center. Dr. Hua’s extensive experience and leadership in drug discovery and
CMC development contribute to the seamless integration of cutting-edge science
with robust manufacturing processes, facilitating the efficient translation of our
ADC research into transformative therapies.
Our core leadership team has assembled a highly experienced senior management team,
each with over 15 years of experience in key functions of our business, including drug
discovery, translational medicine, clinical development, chemistry, manufacturing and controls
(“CMC”), business development, finance, and human resources, to lead our operations. By
bringing together experts in all facets of ADC drug development, we aim to push boundaries
and deliver innovative medicine to patients in need.
We are supported by a scientific advisory board of world-renowned ADC experts to guide
our R&D activities and provide invaluable strategic advice. Key members of our scientific
advisory board include Dr. Antoine Y ver and Dr. Pasi Jänne, two leading minds in ADC drug
development in the world, and Dr. Su Ling, a distinguished expert in drug development and
regulatory affairs. We have had the privilege of working with both Dr. Y ver and Dr. Jänne since
our inception. With the deep relationships we have built, Dr. Y ver, Dr. Jänne and other members
of our scientific advisory board have shared years of knowledge and insights that have been
instrumental in our pipeline R&D, clinical development and global collaboration.
 Dr. Antoine Yver , M.D., M.S., is the chairman of our scientific board. Dr. Y ver is a
world-leading scientist in ADC research and development with over 34 years of
pharmaceutical experience. Dr. Y ver formerly served as the executive vice president,
global head of oncology R&D and chair of the cancer enterprise at Daiichi Sankyo
from 2016 to 2021, where his strategic leadership transformed Daiichi Sankyo from
a small molecule drug company to a world-class oncology company. Dr. Y ver was
the vision leader for Daiichi Sankyo’s ADC pipeline and led the successful
accelerated and practice-changing development of Enhertu
® (trastuzumab
deruxtecan). He previously had been a senior vice president and head of oncology
global medicines development at AstraZeneca, where he led equally successful
development and approvals of TAGRISSO
® and L YNPARZA®. In addition, he held
various clinical development roles at Johnson & Johnson, Schering-Plough, Aventis
Group and Rhone Poulenc Rorer. Dr. Y ver is currently an independent director at
Sanofi, a member of the scientific committee of Institut Gustave Roussy at Paris,
France, as well as board member or special advisor to various companies.
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 Dr. Pasi A. Jänne , M.D., Ph.D., is a world-renowned medical oncologist and
translational scientist. Dr. Jänne is currently a professor of medicine at Harvard
Medical School, the senior vice president for translational medicine and a director
of the Belfer Center for Applied Cancer Science, and an active thoracic medical
oncologist within the Lowe Center for Thoracic Oncology, at the Dana-Farber
Cancer Institute. As a leading PI of early clinical development, he has 25 years of
experience in early clinical development and translational research for oncology
drugs, with a particular focus on lung cancer. He has made seminal therapeutic
discoveries, including as one of the inventors of patents on EGFR mutations. Dr.
Jänne has also contributed instrumentally to the development of several innovative
drugs, including HER3-DXd of Daiichi Sankyo, TAK-788 of Takeda
Pharmaceutical, osimertinib of AstraZeneca, crizotinib of Pfizer, trastuzumab
deruxtecan of Daiichi Sankyo and Astra Zeneca and adagrasib of Mirati
Therapeutics and Bristol Myers Squibb.
 Dr. SU Ling , Ph.D., FDIA. Dr. Su has over 30 years of experience in drug regulatory
and clinical development. Early in his career, he worked in the Bureau of Drugs of
the Ministry of Health, PRC (၍ଣ҅) and in Center for Drug
Evaluation, Food and Drug Administration, U.S. Since 1996, Dr. Su spent 16 years
in various R&D and management positions in multinational pharmaceutical
companies, both in US and China, including an epidemiologist in Merck U.S., a
medical director in Merck Sharp & Dohme China, a senior global regulatory strategy
director at Merck U.S., a pharma development and medical director at Roche
Shanghai, a vice president for Asia Pacific clinical research at Wyeth, and a senior
vice president and head of Greater China pharma development at Novartis. During
2012 to 2016, Dr. Su was a life science strategic advisor in Sidley Austin LLP . Since
2016, Dr. Su has been a venture partner in Lilly Asia V entures. Since 2022, he has
been serving as the chief development officer at Skyline Therapeutics. Dr. Su was
elected as the president of Drug Information Association (“ DIA”), a global
professional association focusing on healthcare product development, during 2012
to 2013, and served on the board of directors of DIA during 2008 to 2014. He is
currently a fellow of DIA. Dr. Su received his bachelor’s degree in pharmacology
from Shanghai Medical University, PRC, his master’s degree in drug clinical
development and Ph.D. in epidemiology from University of North Carolina at
Chapel Hill.
Our shareholder base consists of leading healthcare investors, including Lilly Asia
V entures, King Star Med, AZ-CICC, Yinglian Investment and Golden Sword.
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OUR BUSINESS STRATEGIES
Our mission is to become a global leader in the discovery, development, and
commercialization of innovative ADC therapies. We adhere to a “CP 2” strategy, our formula
centered around Clinical development, Platforms and Pipeline and are expanding its adoption
for the global market. Led by our founder and chief executive officer Dr. ZHU Zhongyuan and
an experienced scientific team, we have established a dedicated global ADC development
engine. Within just four years since our inception, we have built four proprietary technology
platforms and a differentiated and tiered in-house pipeline of innovative ADCs assets.
Building upon these efforts, we will accelerate the global development and
commercialization of our clinical-stage programs to unlock their commercial value. We will
also continue to enhance our global research, clinical development and regulatory expertise to
drive future waves of ADC innovation. By harnessing our innovation capabilities and
value-accretive partnerships, we aim to unlock the full potential of ADCs to transform the
treatment paradigm for oncology, autoimmune diseases and beyond.
Accelerating global development and commercialization of clinical-stage assets
For our first batch of clinical-stage ADC assets, we will continue to drive their global
development and accelerate market entry by leveraging our clinical execution speed and
efficiency and deep regulatory expertise. We have designed bespoke clinical strategies for each
asset for market entrance, broaden coverage to large patient populations and potentially
become the new standard of care.
 First-to-market approach . To maximize the global competitiveness of our pipeline,
we will select and address initial target indications that are commercially attractive
and often underserved, which enable us to demonstrate key asset differentiation, and
rapidly enter and establish a strong presence in the global market. For example,
DB-1303 is the most clinically advanced HER2 ADC candidate globally that targets
EC across HER2-expression levels, according to Frost & Sullivan. We and
BioNTech have completed patient enrollment for DB-1303’s potential registrational
cohort in HER2-expressing advanced/recurrent EC patients and plan to commence
a confirmatory phase 3 trial in this patient population in 2025.
 Fast-to-commercial approach . Complementing our first-to-market strategy, we
utilize a fast-to-commercial approach to accelerate access to our differentiated
assets for a wider addressable population of patients in need. For instance, DB-1303
is a leading candidate for HER2 low-expressing BC, according to Frost & Sullivan,
with potential for extension to other underserved cancer indications. DB-1303 is
undergoing a phase 3 global registrational trial in chemo-naïve HR+/HER2-low
metastatic BC patients with first patient dosed in January 2024. Furthermore,
DB-1311 is currently one of the top three B7-H3 ADCs undergoing global MRCTs
in terms of clinical development progress for advanced SCLC, according to Frost &
Sullivan.
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 Combination and indication expansion strategy . We adopt combination therapy
strategies to unlock the frontline and backbone potential for our assets and offer
improved clinical benefits to patients. For instance, DB-1310 is a global clinical-
stage HER3 ADC candidate being developed for EGFRm NSCLC patients resistant
to osimertinib or other third-generation TKI treatments through combination with
osimertinib. Together with BioNTech, we are actively exploring the combination
potential of our Core Products and DB-1305 as a backbone therapy in early lines of
treatment. In June 2024, the first patient was dosed in a combination cohort of
DB-1305’s ongoing phase 1/2a global trial to evaluate the combination of DB-1305
and BNT327, a bsAb targeting PD-L1 and VEGF, aiming to harness the potent
anti-tumor activity of ADCs along with the sustained benefit of immunomodulators.
In October 2024, we received IND approval from the NMPA to initiate a phase 1/2a
trial for DB-1305 in combination with BNT327 in patients with late-stage/metastatic
solid tumors. Furthermore, DB-1311 is currently undergoing a phase 1b/2 trial in
combination with BNT327, a bsAb targeting PD-L1 and VEGF, in patients with
advanced lung cancer, including SCLC and NSCLC.
Based on DB-1303’s anticipated market launch timeline in China, we have formulated a
cross-functional commercialization plan. Key initiatives include establishing manufacturing
and supply chain management systems, final marketing approval application, as well as
trademark registration and packaging design. We have also begun building our core
commercialization teams, with strategic planning, supply chain management, and partnership
management positions already filled. In January 2025, we entered into a collaboration
agreement with 3SBio Inc. (HKEX: 1530, “ 3SBio ”) through its subsidiaries, pursuant to which
we have appointed 3SBio as our commercialization partner in Mainland China, Hong Kong,
and Macau (the “ Territory ”) to promote DB-1303 for various indications. 3SBio will also
provide related commercialization services to support DB-1303’s market access, medical
affairs, channel management and other commercial activities in the Territory. As the Marketing
Authorization Holder, we will continue to be responsible for advancing the clinical
development and registration of DB-1303 in the Territory before and after commercial launch.
Together with 3SBio, we are formulating a comprehensive marketing and promotional plan for
DB-1303 in the Territory. We intend to implement competitive pricing and market access
strategies, including participating in NRDL negotiations, volume-based procurement programs,
and leveraging other opportunities to maximize DB-1303’s market potential and accessibility.
See “— Commercialization — Partnership with 3SBio to Commercialize DB-1303 in the China
Market” for details.
We believe that the market entry of our clinical-stage assets over the next few years will
propel us into a new phase as a biopharmaceutical company, expanding beyond R&D to
commercialize drugs and maximize their value. In anticipation of this next phase, we will
actively assess potential collaborations and partnerships that could help us establish and grow
our global presence, while building up our in-house capabilities — which span market access,
channel management, medical affairs, and sales and marketing — to drive our overall
commercial strategy, including post-launch clinical development, pricing, healthcare insurance
negotiations, and distribution. We aim to maintain flexibility in our commercialization
approach and adapt to the unique needs of different regions.
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Through our first batch of assets, we showcase the strength and versatility of our
technology platform and our translational medicine capabilities, as well as accumulate global
clinical execution and regulatory expertise. As we bring our innovative therapies to patients in
need, we solidify our position as a leader in the industry, poised for sustained growth and
success.
Rapidly advance next wave of ADC assets by leveraging accumulated global R&D and
regulatory expertise
With our first batch of assets approaching commercialization, we are actively developing
next-generation ADCs that address limitations of existing therapeutics and further improve the
anti-tumor activity and toxicity profiles of earlier generations of ADCs. In line with our
overarching goal to optimize ADCs to treat challenging diseases with improved clinical
outcomes, we are exploring new antibody, payload and linker formats, such as BsADCs and
immune-modulating ADCs. We believe these novel ADC formats can potentially treat patients
that are unresponsive or develop resistance, and expand the therapeutic coverage of ADCs to
new tumor types and disease areas.
We aim to bring multiple bispecific and immune-modulating ADCs into the clinic in the
next few years, with at least one or two INDs obtained each year. We initiated a phase 1/2a
global trial for DB-1419 (B7-H3xPD-L1 BsADC) in 2024. We initiated a phase 1 study in
healthy adults for DB-2304 in Australia in October 2024. We have obtained IND approvals
from the FDA and NMPA for DB-2304 and expect to complete DB-2304’s phase 1 global trial
in 2026. We are conducting IND-enabling studies for DB-1418 (EGFRxHER3 BsADC) and
expect to advance this molecule into clinical stage in the first half of 2025.
We are devising global clinical development plans and regulatory approval strategies to
rapidly advance our second batch of assets into the clinic. In doing so, we will leverage our
accumulated know-how and insights in translational medicine across the world to optimize
drug candidates and clinical trial design for the target indications. Moreover, we will harness
our experience in regulatory affairs to navigate and develop global regulatory strategies and
engage with key regulatory authorities across the U.S., China, the EU and worldwide. Our
global clinical strategy ensures diverse demographic representation, hence enabling wider
market access across various ethnicities and genetic variations. This approach also facilitates
a coordinated and potentially streamlined approval process by adhering to regulatory standards
across jurisdictions. Leveraging our regulatory expertise accumulated over the years, we aim
to continuously advance global drug development with enhanced in-house control and
execution speed.
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Continue technology innovation to unlock the full potential of ADCs and disrupt
treatment landscape
We believe disruptive ADC technology innovation will redefine the treatment landscape
for many therapeutic areas. We will continue to invest extensively in innovation, with a focus
on the following directions:
 Novel payload and linker technology . With our understanding of limitations of
traditional ADCs, such as inadequate efficacy and acquired drug resistance to
existing therapy, our research in the next few years will focus on novel payloads and
linkers to broaden the therapeutic index of our ADCs. We are actively exploring new
mechanism of action and formats to achieve new heights in terms of safety, potency
and activity, and have a number of prototypes under development with promising
broad-spectrum anti-tumor activity and potent bystander killing effects. We believe
these innovations will redefine ADC functionality and chart the course for a new
revolution of the ADC modality.
 AI-driven drug discovery and development . We plan to leverage the power of AI to
accelerate our drug discovery and development efforts, and to remain competitive in
ADC innovation. We have built an AI team to support our R&D efforts with a large
language model-based, machine learning approach. We will continue to invest into
our dedicated computational infrastructure with integrated AI capabilities, based
upon iterative learning through both our “Duality Target Engine,” that comprises
comprehensive omics computational analysis and automatic literature review, and
“Duality Knowledge Base and Retrieval-Augmented Generation Chatbot,” that
centralize internal data and knowledge repositories to further improve efficiency and
accuracy of R&D. By utilizing AI-driven tools and data-based support, we aim to
systematically optimize every stage of our R&D, from target identification, ADC
design and engineering to biomarker discovery, enabling us to finetune our
engineering of next generation ADC candidates to prioritize high-potential targets
and indications.
 Expansion to autoimmune, metabolic and cardiovascular diseases . We believe the
ADC modality represents a more targeted, enhanced and better tolerated approach
for many diseases and conditions beyond oncology. We have designed our
technology platforms with a plug-and-play architecture, which enables us to
engineer different ADCs to unlock the significant potential in multiple non-oncology
therapeutic areas, including autoimmune, metabolic and cardiovascular diseases.
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Maximize clinical and commercial potential of our assets through value accretive
partnerships
Our proven track record of successful global R&D partnerships underscores the
effectiveness of our approach to maximizing value through strategic collaborations. Building
on this foundation, we will continue to actively seek and evaluate different modes of external
partnerships to accelerate the delivery of our innovative therapies to patients across various
markets worldwide. By leveraging the strengths and expertise of our partners, we aim to
expand and deepen our global reach, optimize resource allocation, and ultimately, determine
the right development strategy for the asset program towards approval and commercialization.
 To accelerate global clinical development and maximize commercial value of our
drugs, we will primarily focus on partnerships with leading global
biopharmaceutical companies that will bring synergies to our pipeline and
operations, and innovative global biotech companies with a proven record of
successful drug development. We will maintain flexibility in the form of
collaboration to fully capitalize the value of our assets. In particular, we may seek
to structure the partnerships to retain significant economic interest and upside
potential, and optimize the joint development and control of our clinical and
preclinical programs. Moreover, we will maintain our agile pipeline development,
which leverage our partnerships to provide funding for our in-house assets
development. To date, we have been actively assessing opportunities extended by
various MNCs on our technology platforms and preclinical stage assets.
 In addition to partnerships on an asset level, we will also actively evaluate
collaborative R&D opportunities to enhance and supplement our in-house drug
discovery and research efforts. We will focus on identifying and engaging with
partners who possess complementary expertise and technologies that can synergize
with our own capabilities. These collaborations may span various aspects of ADC
design, such as antibody engineering, novel linker technologies and cutting-edge
payload development. By strategically combining our strengths with those of our
partners, we aim to accelerate future waves of ADC innovation.
Continue to build our global presence and teams across drug research, clinical
development, regulatory affairs and commercialization
In line with our global vision, continued global development of our drug assets and
building robust teams across critical functions will be paramount to our success. We will
continue to conduct global MRCTs with increased in-house control and oversight. This
approach will allow us to ensure consistent quality, maintain regulatory compliance, and gather
diverse patient data to support our global registration strategies.
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In parallel, we will focus on attracting, developing, and retaining top-tier talent across
key areas of drug research and development, including discovery, translational medicine,
clinical operations, regulatory affairs, and commercialization. As we strengthen our global
talent pool, we will be well-positioned to continue to develop innovative assets with global
clinical development strategies executed with speed and efficiency. Ultimately, these efforts
will propel us forward in our journey to become a truly globalized biopharmaceutical company,
recognized for our scientific expertise, operational excellence, and unwavering commitment to
improving patient lives on a global scale.
OUR BUSINESS MODEL
Since our inception, we have focused primarily on the independent discovery and
development of ADC assets. We have assembled a highly experienced team of experts in all
facets of ADC drug development. Their accumulated experience and expertise have driven our
technology platform and pipeline development, executed with quality and operational
efficiency. With our commitment to organic in-house R&D, we have developed four
cutting-edge technology platforms and a pipeline of 12 internally discovered ADC candidates
covering a diverse range of indications, which reflects our understanding of disease biology
and unique insights into target selection.
In the rapidly iterating and highly competitive ADC market, we understand that
development speed is as crucial as asset quality in determining the ultimate success of an ADC
drug. As a biotech company founded in 2019, we have strategically focused our core
competencies on our technology platforms and the critical initial phases of drug development,
from drug discovery to proof-of-concept clinical trials. For late-stage clinical development
(such as global MRCTs) across multiple drug assets, we have taken a strategic and flexible
approach to drug development, leveraging both our internal resources and external partnerships
to rapidly bring our drugs to market. This efficient model allows us to maintain our agility and
innovation as a young biotech company while tapping into the scale and experience necessary
for successful late-stage global development.
Our successful in-house R&D has drawn the attention of global biopharmaceutical
companies, and we have entered into collaborations to accelerate the global expansion of our
drug programs and maximize their impact on patients worldwide. These collaborations are
win-win for us and our partners. We have retained development and commercialization rights
to these assets in certain territories, and have continued to play a core role in the overall
development strategy and direction of these assets on a global level. The partnerships enable
us to maximize the clinical value of our in-house discovered assets and provide financial
resources to further invest in our pipeline development. Moreover, these collaborations provide
our partners with high-quality clinical-stage ADC assets to complement their drug portfolios
and support their long-term strategies.
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Going forward, we expect to continue to implement this business model. We will continue
to lead the development activities of our clinical-stage assets in the regions where we retain
rights, and expect to have multiple assets entering the clinic in the next few years and more in
preclinical studies. We will also continue to optimize our ADC platforms to support further
innovation and remain open to value-accretive R&D partnerships that support our growth.
Anticipating commercialization of our late-stage ADCs, we are proactively developing a
tailored commercial strategy for each asset, harnessing both our in-house capabilities and
external collaboration.
OUR PIPELINE
Overview
As of the Latest Practicable Date, our pipeline comprised 12 in-house discovered ADC
candidates, which we have rapidly established in our short operating history leveraging our
four cutting-edge ADC technology platforms, execution capabilities and experienced R&D
team. Our technology platforms, namely DITAC, DIBAC, DIMAC and DUPAC, serve as the
foundation of our drug discovery and development efforts.
We take a tiered strategy in ADC development, leading the waves of technology iteration
that place us at the forefront of ADC innovation:
 First batch of assets , enabled by DITAC and serving as proof of concept of our
leading ADC technology, our proprietary topoisomerase-based ADC platform,
includes (i) ADC candidates with clinically validated targets strategically developed
for differentiated indications, represented by our Core Product DB-1303, a HER2
ADC, and our key product DB-1305, a TROP2 ADC; and (ii) ADC candidates under
global development for high-potential targets and under-explored indications,
represented by our Core Product DB-1311, a B7-H3 ADC, and our key product
DB-1310, a HER3 ADC;
 Second batch of assets , leveraging DIBAC and DIMAC, our bispecific and
immune-modulating ADC platforms, is represented by next-generation ADCs with
novel formats and components that open ADCs to front-line or difficult-to-treat
settings and new therapeutic areas, such as BsADCs, including DB-1419 (B7-
H3xPD-L1 BsADC), DB-1418 (EGFRxHER3 BsADC) and DB-1421, and immune-
modulating ADCs for autoimmune diseases, including DB-2304 (BDCA2 ADC), and
others; and
 Third batch of assets , enabled by DUPAC, our novel MOA payload ADC platform,
is the driving force behind our novel ADC payload and linker technologies that
potentially disrupt the ADC modality, opening the possibility to reach hard-to-treat
tumors and staying ahead of the growing need to overcome acquired resistance to
existing ADCs.
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The pipeline chart below summarizes the development status of our clinical-stage drug candidates and selected preclinical assets, all of which
are in-house discovered.
Global
Global
Global
TROP2
OC (2L+) Mono
NCT05438329 Trial completion: 2025
Mainland China,
Hong Kong,
Macau
NSCLC (2L+) Mono
NSCLC, OC, CC, TNBC (multiple lines) +PD-L1xVEGF bsAb
Solid Tumors (CC, TNBC, etc.) Mono
HER2
HER2-expressing EC (2L+)
Mono NCT05150691 Trial completion: 2027
Mainland China,
Hong Kong,
Macau
Mono NCT06340568 Trial completion: 2029
HR+/HER2-low BC (chemo naïve) Mono NCT06018337 Trial completion: 2028
HER2+ BC (2L+) Mono NCT06265428 Trial completion: 2026
HER2+ BC (1L) + Pertuzumab
NCT05150691 Trial completion: 2027
Solid Tumors (OC, CRC, esophageal cancer, etc.) Mono
HER3
EGFRm NSCLC (TKI-resistant) + Osimertinib
NCT05785741 Trial completion: 2026 Global
KRASm NSCLC (2L+) Mono
HER2-expressing BC (Post-Enhertu) + Trastuzumab
Solid Tumors Mono
DB-1312
/BG-C9074 B7-H4 Solid Tumors Mono/ + Tislelizumab NCT06233942 Trial completion: 2027 /
DB-1314 Undisclosed Solid Tumors Mono / IND submission: 2026 Global
DB-1317 Undisclosed Solid Tumors Mono / IND submission: 2025 Global
Autoimmune
Program Target Indications (lines of treatment) Mono/Combo Preclinical/
IND-Enabling Phase 1 Phase 2a/
Phase 2 Trial LocationPhase 3 NCT Number Upcoming Milestone Commercial Rights
DITAC – Leading TOP1i ADC Platform
DB-1303
/BNT323
DB-1311
/BNT324
DB-1305
/BNT325
DB-1310
B7-H3
SCLC (2L+) Mono
NCT05914116
Mainland China,
Hong Kong,
Macau
(U.S.: Option to
Co-develop and
Co-commercialize)
Mono
ESCC (2L+) Mono
Solid Tumors (HNSCC, HCC, CC, melanoma, etc) Mono
CRPC (late line)
NSCLC (2L+) Mono
/
/
China
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
Global
FDA Fast
Track DesignationCore Products FDA Breakthrough
Therapy DesignationKey Products NMPA Breakthrough
Therapy Designation
FDA Orphan Drug
Designation
Notes:   (1)
(2)
Abbreviations: Mono = Monotherapy, Combo = Combination Therapy, IND = Investigational New Drug, NCT = National Clinical Trial, ADC = Antibody-drug Conjugate, HER2 = Human Epidermal Growth Factor Receptor 2, HER2-expressing = HER2 Status of Tumor Cells Identified with a Test Score of IHC 1+ or Above, EC = Endometrial Cancer, HR+ = Hormone Receptor
Positive, HER2-low=HER2 Status of Tumor Cells Identified with a Test Score of IHC 1+ or IHC 2+/ISH-,  BC = Breast Cancer, Chemo = Chemotherapy, HER2+ = HER2 Status of Tumor Cells Identified with a Test Score of Either IHC 3+ or IHC 2+/ISH+, OC = Ovarian Cancer, CRC = Colorectal Cancer, SCLC = Small Cell Lung Cancer, CRPC = Castration-resistant Prostate
Cancer, ESCC= Esophageal Squamous Cell Carcinoma, NSCLC = Non-small Cell Lung Cancer, HNSCC = Head and Neck Squamous Cell Carci noma, HCC= Hepatocellular Carcinoma, CC = Cervical Cancer, HER3 = Human Epidermal Growth Factor Receptor 3, EGFRm = EGFR Mutant , TKI = Tyrosine Kinase Inhibitor, KRASm = Kirsten Rat Sarcoma Virus Mutant,
BTC = Biliary Tract Cancer, TROP2 = Human Trophoblast Cell-surface Antigen 2, TNBC = Triple-negative Breast Cancer, PD-L1 = PD-1 Ligand 1, VEGF = Vascular Endothelial Growth Factor, bsAb =  Bispecific Antibody, EGFR = Epidermal Growth Factor Receptor, BDCA2 = Blood Dendritic Cell Antigen 2, MOA = Mechanism of Action, SLE = Systemic Lupus Erythematosus,
CLE = Cutaneous Lupus Erythematosus, FDA = U.S. Food and Drug Administration, NMPA = National Medical Products Administration of the PRC, 1L: first-line treatment, 2L+: second-line or later treatment
For each drug candidate, our clinical development typically begins with a combined phase 1/2a trial, where multiple patient groups across different tumor types or indications are enrolled to assess both safety and efficacy of the drug candidate. Based on the results from these phase 1/2 trials, we determine which indications to prioritize for advancement into later-stage clinical
development. All ongoing clinical trials are subject to regulatory oversight by both the FDA and NMPA, except for DB-1303's phase 3 trial in HER2+ BC patients, which is conducted solely in China and regulated by the NMPA.
BioNTech was the sponsor of this global trial as of the Latest Practicable Date.
BeiGene was serving as the sponsor of this trial as of the Latest Practicable Date.
*
**
**
Single-arm, Potential Registrational Study
Planned Phase 3 Confirmatory Trial *
Key Regulatory
Authorities
N.A.
N.A.
NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
DB-1419 B7-H3 x PD-L1 Solid Tumors Mono NCT06554795 Trial completion: 2027 Global
DB-1418
/AVZO-1418 EGFR x HER3 Solid Tumors Mono / IND submission: 2025 Greater China/
Global
DIBAC – Leading Bispecific ADC Platform
N.A.
FDA, NMPA
N.A.
N.A.
DB-1421 Undisclosed Solid Tumors Mono / IND submission: 2026 Global
DB-1316 Undisclosed Solid Tumors Mono / IND submission: 2026 Global
DB-2304 BDCA2 SLE, CLE Mono NCT06625671 Trial completion: 2026 Global
/
/
Global
DIMAC – Leading Immune-modulating ADC Platform
DUPAC – Unique Novel MOA Payload ADC Platform
N.A.
N.A.
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
FDA, NMPA
Trial completion: 2026
Partners
/N.A.DB-1324 Undisclosed Solid Tumors Mono Mainland China,
Hong Kong, Macau/
AVENZO
THERAPEUTICS
Oncology
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ADC Assets Developed from DITAC Technology Platform
DITAC — A Globally Leading TOP1i ADC Platform
Our clinical-stage assets have shared roots in DITAC, our topoisomerase-based ADC
platform. DITAC is validated by the global clinical data from over 2,000 patients (more than
50% located in the U.S., EU, Australia and other regions outside China) across the U.S., China,
Europe, Australia and other major markets. Compared to ADCs with earlier-generation
payloads such as MMAE, topoisomerase-based ADCs are distinguished for their ability to
target a broader range of tumors. Notably, the bystander effect of topoisomerase-based ADCs
enhances efficacy by allowing the cytotoxic payload to affect neighboring tumor cells that may
not express the target antigen.
DITAC takes a holistic approach to ADC design based on our innovative research in
disease pathology and biological targets. We have developed a library of proprietary linkers
and payloads with meaningful technological improvements, giving us critical optionality in
optimizing each ADC component for the target indication. In various clinical and preclinical
studies, DITAC-based ADCs have demonstrated improved systemic stability, tumor-specific
payload release, bystander-killing effects, and rapid payload clearance, which potentially
translates to a significantly improved therapeutic window. For example, one of our DITAC
ADCs showed superior in vitro plasma stability in human plasma than an in-house produced
DS-8201 analog, as illustrated below.
0 48 96 144 192 240 288 336 384
0
20
40
60
80
100
120
Incubation time (hr)
Change of DAR from baseline
DS-8201 *
Change of DAR from baseline
120
100
80
60
40
0
144 192 240
Incubation time (hr)
0
20
48 96 288 336 384
DS-8201*
0 48 96 144 192 240 288 336 384
0
20
40
60
80
100
120
Incubation time (hr)
Change of DAR from baseline
DS-8201 *
Change of DAR from baseline
120
100
80
60
40
0
144 192 240
Incubation time (hr)
0
20
48 96 288 336 384
DITAC ADC
DS-8201 analog
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Our DITAC ADCs also exhibit sustained, tumor-selective payload release in tumor-
bearing mice and, as illustrated in a preclinical study below, significantly lower free payload
level in circulation.
Free payload release rate
-0.40
-0.20
0.00
0.20
0.40
0.60
0.80
1.00
1.20
0h 2h 4h 6h D1 D2 D4 D7 D14 D21
Release rate %
Time
DS-8201
DITAC ADC
Furthermore, ADCs derived from our DITAC platform have demonstrated promising
immune-modulating properties, showing a strong potential to overcome drug resistance and
improve treatment outcome for cancer patients, especially in combination with
immunotherapy. Notably, DITAC ADCs can robustly induce immunogenic cell death (“ ICD”)
of tumor cells, a clinically validated therapeutic approach where anti-tumor treatments
stimulate an immune response to antigens released by dying cancer cells, followed by dendritic
cell activation and T-cell recruitment. Cytotoxic compounds, such as ADC payloads, vary in
their ability to induce ICD. In a preclinical investigation, our DITAC ADC showed a superior
immunologic effect in a head-to-head comparison with Enhertu
®, evidenced by higher levels
of CXCL10/IP-10, a reported marker of ICD, in peripheral blood mononuclear cells and breast
cancer cells co-culture, as illustrated below.
Innate cytokine CXCL10/IP-10
1000
800
600
400
200
CXCL10/P10 (pg/mL)
Vehicle con
trol
1 nM Enhertu (ADC)1 nM DITAC
 ADC
1 nM iso-IgG1Vehicle con
trol
1 nM Enhertu (ADC)1 nM DITAC
 ADC
1 nM iso-IgG1Vehicle con
trol
1 nM Enhertu (ADC)1 nM DITAC
 ADC
1 nM iso-IgG1
0
1E5 PBMC
1E5 PBMC + 1E4 SK-BR-3
1E5 PBMC + 2E4 SK-BR-3
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DB-1303/BNT323, a late clinical-stage HER2 ADC candidate, our Core Product
Overview
Our Core Product DB-1303 is a in-house discovered, late clinical-stage HER2 ADC
candidate with two ongoing registrational trials (one global trial and one in China) and one
potential global registrational study, with the first indication (HER2-expressing EC) projected
to file for accelerated approval with the FDA as early as 2025. DB-1303 is designed with a
stable, cleavable linker and proprietary topoisomerase-based payload that aim to lower
off-target toxicity and enhance anti-tumor activity, including bystander killing effects. These
features may enable DB-1303 to potentially serve as a new therapeutic option for patients with
HER2-expressing advanced solid tumors, including both patients with high and low expression
levels of HER2. The global HER2 ADC market is expected to increase from US$4.8 billion in
2023 to US$18.5 billion by 2028, representing a CAGR of 30.8%, according to Frost &
Sullivan.
DB-1303 is the most clinically advanced HER2 ADC candidate globally that targets EC
across HER2-expression levels and a candidate in advanced clinical development for HER2
low-expressing BC, according to Frost & Sullivan, with potential for extension to other
underserved cancer indications. DB-1303 has obtained Fast Track and Breakthrough Therapy
Designations from the FDA and Breakthrough Therapy Designation from the NMPA for the
treatment of advanced EC in patients who progressed on or after treatment with immune
checkpoint inhibitors, demonstrating DB-1303’s potential to treat advanced EC patients who
currently have low survival rates and a strong medical need for new and more effective
treatments. Moreover, DB-1303’s antitumor activity has been observed in a range of tumors,
including BC, EC, OC, CRC and esophageal cancer, supported by global clinical data from
patients across the U.S., China and Australia to date.
To further advance DB-1303, we formed a global strategic partnership with BioNTech in
2023 to accelerate its development and maximize its global value. We have granted to
BioNTech an exclusive, royalty-bearing and sublicensable license under certain patents and
know-how owned or otherwise controlled by us to develop, manufacture, commercialize or
otherwise exploit DB-1303 and pharmaceutical products comprising DB-1303 (together
“DB-1303 Products ”) for all uses worldwide except Mainland China, Hong Kong and Macau.
We retain the full rights to develop, manufacture, commercialize and otherwise exploit
DB-1303 and DB-1303 Products in Mainland China, Hong Kong and Macau. See “— Our
Collaboration and Licensing Arrangements — License and Collaboration Agreement with
BioNTech for DB-1303/BNT323” for details.
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Drug Design and Mechanism of Action
HER2 is a cell surface receptor protein within the HER family that plays a key role in
regulating cellular growth, division and survival. Upon activation by ligand binding or
overexpression, HER2 dimerizes with other HER family members, leading to the activation of
downstream signaling cascades such as the PI3K/AKT and MAPK/ERK pathways. These
pathways promote cell proliferation, inhibit apoptosis, and enhance cell migration and
invasion.
The HER2 gene has been shown to be overexpressed in various human cancers, including
cancers of the breast, gastric, colon, salivary gland, bladder and uterine serous carcinoma.
HER2 overexpression results in tumor cell proliferation, apoptosis inhibition, and enhanced
cell migration and invasion, ultimately contributing to the development and progression of
HER2-expressing tumors. Moreover, HER2 overexpression have been associated with
increased tumor aggressiveness, metastatic potential, and resistance to certain
chemotherapeutic agents.
DB-1303 is a HER2-targeted ADC designed with a humanized anti-HER2
immunoglobulin G1 (“ IgG1 ”) mAb, covalently linked to a proprietary topoisomerase I
inhibitor payload (P1003) via a maleimide tetrapeptide-based cleavable linker, with a DAR of
8. The core components of DB-1303 are illustrated below.
DB-1303
Humanized anti-HER2
IgG1 mAb
P1003
(TOP1 inhibitor) DAR = 8
H
u
m
an
i
z
e
d
 an
t
i-
H
E
R
2
I
g
G
1
 m
A
b
P100
3
(
T
O
P1
 i
nh
i
b
i
t
o
r
)
D
A
R
=
 8
DB-1303’s anti-HER2 IgG1 mAb has the same amino acid sequence as Herceptin
(trastuzumab), a clinically proven HER2 mAb. Designed with a cleavable linker that is stable
in plasma, DB-1303 travels through the bloodstream upon IV administration with low free
payload in the system, translating to a potentially favorable safety profile. Upon selectively
binding to HER2 on the surface of tumor cells, DB-1303 is endocytosed into the tumor cell,
where the tetrapeptide-based linker is cleaved by lysosomal enzymes preferentially expressed
in tumor cells, releasing the highly potent P1003 payload. P1003, a derivative of exatecan,
leads to apoptosis of the target tumor cells via the inhibition of topoisomerase I. DB-1303 is
also expected to exhibit HER2-specific antitumor activity through antibody-dependent cellular
cytotoxicity (“ ADCC ”) activity and bystander killing effect.
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Market Opportunity and Competition
As of the Latest Practicable Date, Kadcyla ®, Aidixi ® and Enhertu ® were the only three
HER2 ADCs approved globally or in China, with Enhertu ® being the only topoisomerase-based
ADC, and there were three HER2 ADCs in phase 3 clinical development or beyond under
global MRCTs. The global HER2 ADC market was US$4.8 billion in 2023 and is projected to
increase to US$18.5 billion in 2028, representing a CAGR of 30.8%. In China, the HER2 ADC
market was US$0.3 billion in 2023 and is projected to increase to US$1.7 billion in 2028,
representing a CAGR of 46.0%. For more details on the addressable market and competitive
landscape of HER2 ADCs, see “Industry Overview — Global HER2 ADC Market — Market
Opportunities of HER2 ADCs.”
We face fierce competition in the HER2 ADC market from existing and future ADCs
directed against the same molecular targets and indicated for the same indications. Such
competition may become more intense by future collaborations, mergers and acquisitions in the
biopharmaceutical industry. For details of the key features of DB-1303 in comparison with
other HER2 ADCs, see also “Industry Overview — Global HER2 ADC Market — Competitive
Landscape.”
To compete effectively in the HER2 ADC markets, we are driving the clinical
development of DB-1303 with a differentiated strategy focused on under-served indications,
such as HER2-expressing EC and HER2 low-expressing BC, where existing treatments fail to
offer satisfactory clinical benefits to patients. DB-1303 is designed with a stable, cleavable
linker and proprietary topoisomerase-based payload that aim to lower off-target toxicity and
enhance anti-tumor activity, including bystander killing effects. These features may enable
DB-1303 to potentially serve as a new therapeutic option for patients with HER2-expressing
advanced solid tumors, including both patients with high and low expression levels of HER2.
HER2-expressing EC. EC is one of the most common gynecological cancers in the world.
As one of the fastest growing cancers in terms of incidence, new cases of EC increased from
343.9 thousand in 2018 to 401.7 thousand in 2023 and are projected to reach 494.1 thousand
in 2032. While EC has traditionally been more prevalent in post-menopausal women, there is
a growing incidence in younger women, indicating increasing medical needs. HER2
overexpression is reported in 17-30% of total EC cases and HER2 low-expression is reported
in 47-53% of total EC cases.
In China and the U.S., primary treatment options for HER2-expressing EC include
taxane-based chemotherapy, HER2 mAbs, and immunotherapies such as PD-(L)1 inhibitors.
For details of the treatment paradigm of EC in China and the U.S., see “Industry Overview —
Global HER2 ADC Market — Market Opportunities of HER2 ADCs — Endometrial Cancer.”
The current treatment paradigm for EC has significant limitations. For patients not suitable for
total hysterectomy, traditional drug treatments have substantial side effects. In addition, a
significant percentage of patients develop advanced and recurrent disease after first-line
treatment, and have limited response to second- or third-line treatment.
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As of the Latest Practicable Date, no HER2 ADC had been approved for EC across
HER2-expressing level globally. As of the same date, there were five HER2 ADCs targeting EC
across HER2-expressing level in phase 2 clinical development or beyond globally. For details,
see “Industry Overview — Global HER2 ADC Market — Competitive Landscape.”
HR+/HER2-low BC. HER2-low BC is the most prevalent subtype of BC, accounting for
approximately 50% of total BC cases. Global incidence of HER2-low BC increased from
1,044.4 thousand cases in 2018 to 1,204.0 thousand cases in 2023, and is projected to reach
1,597.9 thousand cases by 2032. Traditionally, HER2 ADCs were designed to target and were
believed to be effective only against HER2+ BC. However, recent advancements in ADC
design, including the development of topoisomerase-based payloads, have resulted in
successful applications of HER2 ADCs for HER2-low BC patients.
Endocrine therapies (“ ET”), such as aromatase inhibitors and a selective estrogen
receptor degrader, represent the cornerstone of standard first-line and second-line treatment
options for advanced HER2-low BC in China and the U.S. However, the recurrence rate after
using ET is approximately 40-50%. Limited effective treatment options are available for
recurrent patients, leaving a need for effective non-endocrine therapy-based treatment.
Trastuzumab deruxtecan (Enhertu
®, HER2 ADC) is recommended as second-line or later
treatment for HER2-low BC patients in China and the U.S. For details of the treatment
paradigm of HR+/HER2-low BC in the U.S and in China, see “Industry Overview — Global
HER2 ADC Market — Market Opportunities of HER2 ADCs — Breast Cancer — HER2-low
BC.”
As of the Latest Practicable Date, only one HER2 ADC, Enhertu
®, was approved for
HR+/HER2-low BC and only for patients who have received a prior chemotherapy in the
metastatic setting or developed disease recurrence during or within six months of completing
adjuvant chemotherapy. As of the same date, there were nine HER2 ADCs targeting
HR+/HER2-low BC in phase 2 clinical development or beyond globally. For details, see
“Industry Overview — Global HER2 ADC Market — Competitive Landscape.”
HER2+ BC. HER2+ BC is an aggressive type of BC, representing approximately 15-30%
of total BC cases. About 20-25% of HER2+ BC patients present with advanced disease at the
time of diagnosis, and 20% of early-stage patients eventually develop advanced disease. The
global incidence of HER2+ BC increased from 470.0 thousand cases in 2018 to 541.8 thousand
cases in 2023 and is expected to reach 719.0 thousand cases in 2032.
The treatment paradigm for HER2+ BC in China and the U.S. primarily comprises
combination therapy of taxane-based chemotherapy plus HER2 mAbs such as pertuzumab and
trastuzumab, HER2 ADCs and other targeted therapy options. For details of the treatment
paradigm of HER2+ BC in China and the U.S., see “Industry Overview — Global HER2 ADC
Market — Market Opportunities of HER2 ADCs — Breast Cancer — HER2+ BC.” With the
approval of effective treatments such as HER2 ADCs in recent years, HER2+ BC patients have
experienced increased progression free survival (“ PFS”) and overall survival (“ OS”).
However, there is still a risk of acquired resistance and need for safer treatments for long-term
use. Kadcyla
®, for example, carry a black box warning issued by the FDA for hepatic, cardiac
and embryo-fetal toxicities. These limitations highlight a need for safer treatments that can
prolong the survival for relapsed or refractory patients.
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--- page 339 ---
As of the Latest Practicable Date, Kadcyla ® and Enhertu ® were the only two HER2 ADCs
indicated for HER2+ BC approved both in the U.S and in China. As of the same date, there
were 15 HER2 ADCs targeting HER2+ BC in phase 2 clinical development or beyond globally.
For details, see “Industry Overview — Global HER2 ADC Market — Competitive Landscape.”
In addition to the indications described above, DB-1303’s antitumor activity has been
observed in a range of tumors, including OC, CRC and esophageal cancer, signifying its
potential for indication expansion.
Key Advantages
 Most clinically advanced HER2 ADC globally for EC patients across HER2-
expression levels. EC is known to be one of the most common gynecological
malignancies globally. Both the reported incidence and mortality of EC have
increased in the last decade, especially in younger women, with approximately
400,000 new cases reported worldwide in 2023, according to Frost & Sullivan.
Approved first- and second-line standard-of-care treatments for EC, including
chemotherapy and targeted therapies, have shown limited efficacy in advanced or
metastatic EC patients, highlighting an unmet medical need. The five-year survival
rate for EC patients with advanced, metastatic or recurrent disease is estimated at
only 18%. The global EC drug market is expected to increase from US$5.3 billion
in 2023 to US$9.0 billion by 2028, representing a CAGR of 11.2%, according to
Frost & Sullivan.
We aim to improve treatment for EC patients across HER2-expression levels. To
date, the only approved HER2 ADC available for EC patients globally is indicated
for pan-HER2+ solid tumors and hence covers only HER2+ (IHC 3+) EC, which is
estimated to account for around 17-30% of the EC patient population. Beyond this
small subset of patients, approximately 47-53% of EC patients are HER2 low-
expressing with very limited treatment options, according to Frost & Sullivan.
DB-1303 is differentiated by observed anti-tumor activity across both HER2-low
(IHC 1+ and IHC 2+) and HER2+ EC patients, which potentially expands its
suitability to over 70% of the EC patient population. Notably, DB-1303
demonstrated an ORR of 58.8% and DCR of 94.1% in heavily pre-treated
HER2-expressing EC patients (IHC 1/2/3+ or ISH-positive), including those with
prior immunotherapy or anti-HER2 antibody treatments, in its phase 1/2a trial,
preliminary data of which were published at the 2023 ESGO.
DB-1303 has obtained Fast Track and Breakthrough Therapy Designations from the
FDA and Breakthrough Therapy Designation from the NMPA for the treatment of
advanced EC in patients who progressed on or after treatment with immune
checkpoint inhibitors. We and BioNTech have completed patient enrollment for
DB-1303’s potential registrational cohort in HER2-expressing advanced/recurrent
EC patients and plan to commence a confirmatory phase 3 trial in this patient
population in 2025.
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 Potential treatment for chemo-naïve HR+/HER2-low BC patients. BC is known to be
the second largest cancer type in the world by incidence, according to Frost &
Sullivan, with approximately 2.4 million new cases reported in 2023 of which
HER2-low patients accounted for approximately 50%. The global HER2-low BC
drug market is expected to increase from US$17.2 billion in 2023 to US$25.9 billion
by 2028, representing a CAGR of 8.5%, according to Frost & Sullivan. Response to
first-line therapies, including ET in combination with CDK4/6 inhibitors or
chemotherapy, is limited and patients face even fewer available treatment options
and poor prognosis after disease progression. According to Frost & Sullivan, the
only HER2 ADC approved for HER2-low BC to date is currently indicated for
patients who have received a prior chemotherapy in the metastatic setting or
developed disease recurrence during or within six months of completing adjuvant
chemotherapy. We are advancing, in collaboration with BioNTech, a phase 3 global
registrational trial for DB-1303 in chemo-naïve HR+/HER2-low metastatic BC
patients with first patient dosed in January 2024.
 Phase 3 topoisomerase-based ADC for HER2+ BC in China. About 15-30% of BC
patients are HER2+, with a significant patient population of approximately 92.7
thousand in China in 2023, according to Frost & Sullivan. Despite the potential of
topoisomerase-based ADCs to offer significantly improved progression-free
survival and overall survival compared to existing treatments, there is only one
topoisomerase-based HER2 ADC approved in China to date. We plan to complete
our phase 3 registrational trial in China in 2026 for DB-1303 versus T-DM1
(trastuzumab emtansine) in patients with HER2+ unresectable and/or metastatic BC
previously treated with trastuzumab and taxane and file BLA with the NMPA by the
end of 2025.
 Promising efficacy data in phase 1/2a global trial. DB-1303 demonstrated
encouraging efficacy results in its phase 1/2a global trial, based on preliminary data
as of January 13, 2023 published at the 2023 ASCO. The uORR and DCR across all
dose levels was 44.2% and 88.5%, respectively, in patients with HER2 expressing
solid tumors with a median of seven previous lines of treatment, including prior
HER2 ADC regimens, as of January 13, 2023. ORR and DCR were 38.5% and 84.6%
in heavily pre-treated HER2-low BC patients, respectively, and 50% and 96.2% in
heavily pre-treated HER2+ BC patients, respectively, supporting the initiation of
later-stage trials. In addition, preliminary antitumor activity has also been observed
in other tumor types, including OC, CRC and esophageal cancer, signifying
DB-1303’s potential for indication expansion.
 Manageable safety profile. DB-1303 was well-tolerated with no DLT observed in all
six dose levels (ranging from 2.2 mg/kg to 10 mg/kg) during dose escalation and no
TEAEs associated with death in phase 1/2a global trial as of January 13, 2023, with
grade 3 or above TRAEs reported in 12.9% (11/85) of patients. Few patients
experienced neutropenia (11.8%) and alopecia (3.5%). Based on preclinical data
published at the 2022 AACR Annual Meeting, the HNSTD of DB-1303 is 80 mg/kg
in cynomolgus monkeys while the reported HNSTD of DS-8201 was 30 mg/kg. In
the same study, DB-1303 also exhibited superior stability and systemic clearance of
payload compared to DB-8201a, which potentially contributes to a better safety
profile resulting from maintenance of efficacy and reduction of systemic toxicity
risk from free payload.
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Clinical Development Plan
Based on the IND approvals from the FDA and NMPA, we initiated a phase 1/2a global
trial for DB-1303 in advanced or metastatic solid tumors in January 2022. As the first-in-
human study for DB-1303, this phase 1/2a clinical trial provides foundational data that informs
our regulatory discussions with the competent authorities and shapes our late-stage clinical
development strategy. We completed the phase 1 dose escalation study of the phase 1/2a global
trial in January 2023, and initiated the phase 2a dose expansion study of this trial in the same
month. DB-1303 is being investigated in multiple cohorts for various solid tumors in an
ongoing phase 2a dose expansion study and has advanced into two registrational trials (one
global trial and one in China) and one potential global registrational study. In general, if
approved, DB-1303 with different indications would be regulated as the same product by each
competent authority.
In collaboration with BioNTech, we are advancing DB-1303 towards the market with the
first indication projected to file for accelerated approval with the FDA as early as 2025:
 First-to-market approach. We strategically adopt a first-to-market approach for
DB-1303 as a potential treatment for EC across all HER2-expression levels (IHC3+,
2+, 1+ or ISH-positive) to rapidly establish a presence in the global market. As of
the Latest Practicable Date, patient enrollment had been completed for DB-1303’s
registrational cohort in HER2-expressing patients with advanced/recurrent EC, with
a confirmatory phase 3 trial planned to commence in 2025. DB-1303 has obtained
Fast Track and Breakthrough Therapy Designations by the FDA and Breakthrough
Therapy Designation by the NMPA for the treatment of advanced EC in patients who
progressed on or after treatment with immune checkpoint inhibitors. Subject to the
results of this potential registrational study, we and BioNTech plan to file for
accelerated approval with the FDA as early as 2025.
 Fast-to-market approach. We are advancing, in collaboration with BioNTech, a
phase 3 global registrational trial for DB-1303 in chemo-naïve HR+/HER2-low
metastatic BC patients, with the first patient dosed in January 2024. We plan to
develop DB-1303 for other prevalent tumor types, including HER2+ BC. We are
conducting a phase 3 registrational trial in China for unresectable and/or metastatic
BC patients previously treated with trastuzumab and taxanes and plan to file BLA
with the NMPA for this indication by the end of 2025. Building on DB-1303’s
clinical data from its ongoing trials, we plan to further explore its combination
potential as an early line treatment, including for HER2-low BC and other BC
subtypes. For example, DB-1303 is currently undergoing a phase 1/2 trial in
combination with BNT327, a bsAb targeting PD-L1 and VEGF, in patients with
HR+/HR-, HER2-low, HER2-ultralow, or HER2-null BC.
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The table below sets forth details of DB-1303’s clinical development plan:
Indication (lines of
treatment)
Mono/
Combo-therapy Trial phase Region Trial status
(Planned) Trial
start date
(Planned) Trial
completion date
1. Advanced or metastatic
solid tumors*
Mono/
Combo (1)
Phase 1/2a Global Phase 1:
completed
January 2022 (2027)
Phase 2a:
ongoing
2. HER2-expressing EC
(2L+)*
Mono Potential registrational
study (2)
Global Ongoing September 2023 (2025)
3. HR+/HER2-low BC
(chemo naïve)
Mono Phase 3 registrational
trial
Global Ongoing January 2024 (2028)
DYNASTY-Breast02 *
4. HER2+ BC (2L+) Mono Phase 3 registrational
trial
China Ongoing January 2024 (3) (2026)
DYNASTY-Breast01 *
5. HER2-expressing
EC (2L+)**
Mono Planned phase 3
confirmatory
trial
(2)
Global Planned (2025) (2029)
Notes:
* We were the sponsor of this study as of the Latest Practicable Date.
** BioNTech was the sponsor of this study as of the Latest Practicable Date and the holder of IND approval from
the FDA.
(1) As part of this trial, DB-1303 is being investigated as a potential first-line treatment for HER2+ BC in
combination with pertuzumab.
(2) Based on communications with the FDA and NMPA in September 2023 and April 2024, respectively, we and
BioNTech are (i) conducting a potential registrational study of DB-1303 in HER2-expressing EC patients
(which is a single arm study converted from DB-1303’s phase 2a dose expansion cohort for the same
indication), results from which will be used to support the application for accelerated approval (in the U.S.)
and conditional approval (in China) for this indication; and (ii) planning a phase 3 confirmatory trial for
DB-1303 in HER2-expressing EC patients, as required for full marketing approval post-
accelerated/conditional approval. For more details on the regulatory pathways of accelerated approval (U.S.)
and conditional approval (China), see “Regulatory Overview — PRC Regulation — Regulations on
Pharmaceutical Product — Accelerated Approval for Clinical Trial and Registration” and “Regulatory
Overview — Overview of Laws and Regulations in the United States — Laws and Regulations in Relation to
New Drug — Expedited Development and Review Programs.”
(3) We conducted preliminary trial preparations, such as trial site selection and CRO engagement, in parallel with
our IND application to the NMPA for this phase 3 registrational trial, which was approved in April 2024.
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The table below sets forth the drug development timeline for DB-1303.
Milestone/Stage Timeline
Preclinical development /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118September 2020 to
December 2021
IND approval from FDA /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118December 2021
IND approval from NMPA /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118April 2022
Phase 1/2a clinical trial in advanced or metastatic
solid tumors /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Start date:
U.S.: January 2022
China: June 2022
Completion date:
Phase 1: January 2023
Phase 2a: 2027 (planned)
License and collaboration agreement with BioNTech /H1118March 2023
Potential registrational study in HER2-expressing EC /H1118September 2023-ongoing
Phase 3 registrational trial in HR+/HER2-low BC
(DYNASTY-Breast02 ) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118January 2024-ongoing
Phase 3 registrational trial in HER2+ BC
(DYNASTY-Breast01 ) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118January 2024-ongoing
Commence confirmatory phase 3 trial in HER2-
expressing EC patients /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182025 (planned)
Filing for accelerated approval with the FDA for
HER2-expressing EC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182025 (planned)
Filing for BLA with the NMPA for HER2+ BC /H1118/H1118/H1118/H1118/H11182025 H2 (planned)
Data readout from phase 3 registrational trial in
HER2+ BC in China /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182026 H1 (planned)
Summary of Clinical Trial Data
DYNASTY -Breast02, a Phase 3 Global Clinical Trial for HR+/HER2-low BC (NCT06018337)
This is a phase 3, randomized, multicenter, open-label study of DB-1303 vs investigator’s
choice chemotherapy in HR+/HER2-low metastatic BC subjects whose disease has progressed
on at least two lines of prior ET or within six months of first line ET + CDK4/6 inhibitor in
the metastatic setting.
Trial Design . Approximately 532 subjects with HER2 low-expression (IHC 2+/ISH- and
IHC 1+) will be randomized 1:1 across approximately 230 centers globally to receive either
DB-1303, at a dosage of 8 mg/kg Q3W, or investigator’s choice single agent chemotherapy
(capecitabine, paclitaxel or nab-paclitaxel) until Response Evaluation Criteria in Solid Tumors
(“RECIST ”) v1.1 defined disease progression, unless there is unacceptable toxicity,
withdrawal of consent, or another criterion for discontinuation is met.
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Trial Objectives . The primary purpose of the study is to determine the efficacy and safety
of DB-1303 compared with investigator’s choice single agent chemotherapy in chemotherapy-
naïve patients with HR+/HER2-low metastatic BC that have progressed on hormone therapy.
The study’s primary endpoint is PFS by Blinded Independent Central Review (“ BICR ”)
according to RECIST v1.1 in the HR+/HER2-low population. Secondary endpoints include OS,
ORR, PFS by investigator assessment, duration of response (“ DOR”), safety parameters
including TEAEs and serious adverse events (“ SAEs ”) per National Cancer Institute Common
Terminology Criteria for Adverse Events v5.0, and quality of life of patients evaluated using
the European Organization for Research and Treatment of Cancer (“ EORTC ”) Quality of Life
Questionnaire, among other outcome measures.
Trial Progress . This trial was initiated in January 2024 and is currently recruiting
patients.
DYNASTY -Breast01, a Phase 3 Clinical Trial for HER2+ BC in China (NCT06265428)
This is a phase 3, multicenter, open-label, randomized controlled study evaluating
DB-1303 versus T-DM1 (trastuzumab emtansine) in patients with HER2+ unresectable and/or
metastatic BC previously treated with trastuzumab and taxane.
Trial Design . Approximately 224 patients with unresectable or metastatic HER2+ BC will
be randomized 1:1 to receive DB-1303, at a dosage of 8 mg/kg Q3W, or T-DM1, at a dosage
of 3.6 mg/kg Q3W, respectively, until RECIST v1.1 defined disease progression, unless there
is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.
Trial Objectives . The primary purpose of the study is to compare the PFS benefit of
DB-1303 with T-DM1 in patients with HER2+ unresectable/metastatic BC previously treated
with trastuzumab and paclitaxel. The study’s primary endpoint is PFS by BICR according to
RECIST v1.1.
Trial Progress . This trial was initiated in January 2024 and is currently recruiting
patients.
Potential Registrational Study for HER2 Expressing EC (NCT05150691)
This is a potential registrational study conducted as part of DB-1303’s phase 1/2a global
trial in advanced/metastatic solid tumors. This study is a multicenter, open-label, non-
randomized study to assess DB-1303 for use as a potential treatment for patients with advanced
EC who have progressed on or after standard systemic treatment.
Based on communications with the FDA and NMPA in September 2023 and April 2024,
respectively, results from this potential registrational study will be used to support the
application for accelerated approval (in the U.S.) and conditional approval (in China) for
HER2-expressing EC. A phase 3 confirmatory trial for DB-1303 in HER2-expressing EC
patients is required for full marketing approval post-accelerated/ conditional approval. For
more details on the regulatory pathways of accelerated approval (U.S.) and conditional
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approval (China), see “Regulatory Overview — PRC Regulation — Regulations on
Pharmaceutical Product — Accelerated Approval for Clinical Trial and Registration” and
“Regulatory Overview — Overview of Laws and Regulations in the United States — Laws and
Regulations in Relation to New Drug — Expedited Development and Review Programs.”
Study Design . Patients with advanced/unresectable, recurrent, or metastatic HER2-
expressing (IHC 1/2/3+ or ISH+) EC have been enrolled and are treated with DB-1303,
including subjects with or without prior immune checkpoint inhibitor (“ ICI”) treatments. This
registrational study is a single-arm study converted from one of DB-1303’s phase 2a dose
expansion cohorts for the same indication, as part of its phase 1/2a global clinical trial for
advanced/metabolic solid tumors (which collectively enrolls approximately 766 patients).
Study Objectives . The primary objectives of the study are to asses the safety and
tolerability of DB-1303 and evaluate the efficacy of DB-1303 among HER2 expressing EC
patients. The study’s primary endpoints include SAEs, TEAEs and ORR assessed by
independent review committees (“ IRC”) in all HER2-expressing (confirmed by central
laboratory) subjects.
Study Progress . This study is currently ongoing with patient enrollment completed. We
published the preliminary data from DB-1303’s dose escalation and expansion studies in
patients with HER2-expressing advanced/metastatic EC at the 2023 ESGO.
As of May 8, 2023, the data cut-off date for the 2023 ESGO, 32 patients with EC received
7 or 8 mg/kg doses of DB-1303. The median treatment duration was 2.6 (range, 0.7-10.4)
months with 29 patients (90.6%) remaining on treatment. Median number of prior regimens for
metastatic disease was 2 (range, 1-10). Nineteen patients (59.4%) had prior immunotherapy
therapy.
Efficacy Data. DB-1303 demonstrated promising antitumor activity with high disease
control in patients with advanced/metastatic EC, including serous and carcinosarcomas. As of
May 8, 2023, 17 patients were evaluable for response. Ten patients (58.8%) had objective
partial tumor response per RECIST v1.1. The ORRs for patients at 7 and 8 mg/kg dose were
50.0% (2/4) and 61.5% (8/13), respectively. The overall DCR was 94.1%. The table below sets
forth a summary of the efficacy data as of May 8, 2023.
Dose Escalation
Dose
Expansion
Response (1)
7 mg/kg
(n=4) (2)
8 mg/kg
(n=4) (2)
8 mg/kg
(n=9) (2)
Pooled
8 mg/kg
(n=13)
Total
(n=17) (2)
Best Overall Response, n (%)
PR /H1118/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 (50.0) 4 (100) 4 (44.4) 8 (61.5) 10 (58.8)
SD /H1118/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 (50.0) 0 4 (44.4) 4 (30.8) 6 (35.3)
PD /H1118/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 0 1 (11.1) 1 (7.7) 1 (5.9)
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Dose Escalation
Dose
Expansion
Response (1)
7 mg/kg
(n=4) (2)
8 mg/kg
(n=4) (2)
8 mg/kg
(n=9) (2)
Pooled
8 mg/kg
(n=13)
Total
(n=17) (2)
Unconfirmed ORR, n (%) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182 (50.0) 4 (100) 4 (44.4) 8 (61.5) 10 (58.8)
Confirmed ORR, n (%) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 (25.0) 3 (75.0) 0 3 (23.1) 4 (23.5)
Pending Confirmation ORR, n (%) /H1118/H1118/H1118/H1118/H11181 (25.0) 1 (25.0) 4 (44.4) 5 (38.5) 6 (35.3) (3)
Unconfirmed ORR By Histology, n/N (%)
Serous Carcinoma /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181/1 (100) 4/4 (100) 2/3 (66.7) 6/7 (85.7) 7/8 (87.5)
Adenocarcinoma /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181/2 (50.0) – (4) 0/1 0/1 1/3 (33.3)
Carcinosarcoma /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–(4) –(4) 1/2 (50.0) 1/2 (50.0) 1/2 (50.0)
Mixed Adenocarcinoma /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–(4) –(4) 1/2 (50.0) 1/2 (50.0) 1/2 (50.0)
Unconfirmed DCR, n (%) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184 (100) 4 (100) 8 (88.9) 12 (92.3) 16 (94.1)
Notes:
1. By investigator
2. Response evaluable participants, which includes participants with 1 post-baseline overall response
3. As of the Latest Practicable Date, all six PRs had been confirmed
4. No efficacy evaluable participants
Nearly all participants with post-baseline scans had a reduction in target lesions. The
waterfall plot below shows the best percentage change from baseline of target lesions in all
patients with post-baseline scans.
Best Tumor Response for EC PTs with Post-baseline Scans
-120
-90
-60
-30
0
30
60
90
120
Best Change from Baseline (%)
Subject
8 mg/kg7m g / k gDose Level
3+2+1+HER2 IHC Status
+HSI
+HSI
+HSI
+HSI
+HSI
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The spider plot below sets forth the target lesion tumor response over time in all patients
with post-baseline scans.
-100
-50
0
50
100
Best Change from Baseline (%)
0 10 20 30
Duration of Treatment (weeks)
8m g / k g7m g / k gDose Level
SD
PR
PD
Response
Safety Data . DB-1303 showed a manageable safety profile. As of May 8, 2023, no TEAEs
leading to death or dose discontinuation occurred. No adverse event of special interest
(“AESI ”) occurred, and no DLT was observed in dose escalation. The following table sets forth
a summary of the safety data as of May 8, 2023.
Dose Escalation
Dose
Expansion
Events, n (%)
7 mg/kg
(n=4) (2)
8 mg/kg
(n=4) (2)
8 mg/kg
(n=9) (2)
Pooled
8 mg/kg
(n=13)
Total
(n=17) (2)
TEAEs /H1118/H1118/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 (100) 4 (100) 22 (91.7) 26 (92.9) 30 (93.8)
Study treatment related /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184 (100) 4 (100) 18 (75.0) 22 (78.6) 26 (81.2)
Grade /H113503 TEAEs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182 (50.0) 1 (25.0) 7 (29.2) 8 (28.6) 10 (31.2)
Study treatment related /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 (25.0) 0 4 (16.7) 4 (14.3) 5 (15.6)
Serious TEAEs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 (25.0) 0 3 (12.5) 3 (10.7) 4 (12.5)
TEAEs associated with dose reduction /H1118/H1118/H1118/H1118/H11180 0 1 (4.2) 1 (3.6) 1 (3.1)
Study treatment related /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180 0 1 (4.2) 1 (3.6) 1 (3.1)
TEAEs associated with dose interruption /H1118/H1118/H1118 0 0 3 (12.5) 3 (10.7) 3 (9.4)
Study treatment related /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180 0 2 (8.3) 2 (7.1) 2 (6.2)
TEAEs associated with dose discontinuation /H1118 0000 0
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Notes:
AESI = Adverse event of special interest; DLT = Dose-limiting toxicity; ILD = Interstitial lung disease; LVEF = Left
ventricular ejection fraction; TEAE = Treatment emergent adverse event
1. TEAEs was defined as AEs with a start or worsening data on or after the start of study treatment
2. AESIs include LVEF decrease (grade /H113503), ILD/pneumonitis, and IRRs (grade /H113503)
3. DLT was defined as any TEAE not attributable to disease or any disease-related process that occurs during the
DLT evaluation period (days 1-21 in cycle 1)
The most frequent TEAEs of any grade were nausea (16 grade 1-2; 0 /H11350grade 3), fatigue
(10 grade 1-2; 0 /H11350grade 3) and vomiting (8 grade 1-2; 1 /H11350grade 3). The chart below sets forth
the TEAEs occurring in /H1135010% of the participants. No interstitial lung disease occurred.
Nausea
Fatigue
V omiting
Decreased Appetite
Hypokalaemia
Anaemia
Oedema Peripheral
Aspartate Aminotransferase Increased
Alanine Aminotransferase Increased
50.0
31.2
28.1
15.6
15.6
15.6
12.5
12.5
12.5
TEAE (%)
0 5 10 15 20 25 30 35 40 45 50 55 60
Grade ≥3
Grade 1-2
3.1
3.1
12.5
6.2
Phase 1/2a Global Clinical Trial for Advanced/Metastatic Solid Tumors (NCT05150691)
This is a phase 1/2a, multicenter, open-label, first-in-human study to assess the safety,
tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1303 in patients with
advanced/metastatic solid tumors.
Trial Design . This study enrolls approximately 766 patients with HER2 (high or
low)-expressing solid tumors to receive DB-1303 as a treatment. This trial consists of two
parts: phase 1 dose escalation study and phase 2a dose expansion study. The dose escalation
study adopts an accelerated titration at first dose level (2.2 mg/kg) followed with a classic
“3+3” dose escalation design (4.4, 6.0, 7.0, 8.0, 10.0 and 12.0 mg/kg) given intravenous Q3W
to identify the maximum tolerated dose (“ MTD”) and RP2D. In the dose expansion study,
patients are assigned to different cohorts to receive DB-1303 at the MTD/RP2D to confirm the
safety, tolerability and explore efficacy in selected malignant solid tumors.
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Trial Objectives . The primary objective of the phase 1 dose escalation study is to evaluate
the safety and tolerability and determine the MTD/RP2D. The primary endpoints of the phase
1 study are safety and tolerability measured by DLT, SAEs, TEAEs, MTD and RP2D, among
others. Secondary endpoints include efficacy (measured by ORR, DoR, DCR, TTR, PFS, OS
per RECIST v1.1), PK, and immunogenicity.
The primary objective of the phase 2a dose expansion study is to assess safety, tolerability
and efficacy of DB-1303 at the MTD/RP2D. The primary endpoints of the phase 2a study
include SAEs, TEAEs and ORR, among others. Secondary endpoints include efficacy
(measured by percentage change in target lesions, DoR, DCR, TTR and time on therapy per
RECIST v1.1), PK, and immunogenicity.
Trial Progress . The phase 1 dose escalation study was initiated in January 2022 and
completed in January 2023, with all primary endpoints met and RP2D determined at 8 mg/kg.
The phase 2a dose expansion study was initiated in January 2023 and is currently ongoing. The
preliminary results from the phase 1 dose escalation study were published at the 2023 ASCO
Annual Meeting. As of January 13, 2023, the data cut-off date for the 2023 ASCO, 85 patients
had received DB-1303 at six dose levels (2.2, 4.4, 6.0, 7.0, 8.0, and 10.0 mg/kg). As of the
same date, the median duration of treatment was 63.0 (range, 21-211) days and 68 pts (80.0%)
remained on treatment.
These patients were heavily pretreated and had received a median of seven (range, 1-27)
prior lines of therapy, including 28 patients (32.9%) who had received prior anti-HER2 ADC
therapy. The table below sets forth the baseline characteristics of the 85 patients.
Total (n=85)
Age, median (range) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111852.0 (30.0-79.0)
Female , n (%) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111878 (91.8%)
Region , n (%)
US/AUS /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111830 (35.3%)
CHN /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111855 (64.7%)
ECOG PS , n (%)
0 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111822 (25.9%)
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111863 (74.1%)
Number of Prior Systematic Regimens in the Metastatic Disease , median
(range) 7.0 (1-27)
Cancer Type , n (%) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
HER2 Positive Breast Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111842 (49.4%)
HER2 Low Breast Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (24.7%)
Endometrial Carcinoma /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (7.1%)
Colorectal Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (3.5%)
Ovarian Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (3.5%)
Esophageal Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (2.4%)
Gastric Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (1.2%)
Gastroesophageal Junction Adenocarcinoma /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 (1.2%)
Non-small Cell Lung Cancer /H1118/H1118/H1118/H1118/H1118/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 (1.2%)
V aginal Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (1.2%)
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Total (n=85)
Site of Metastasis , n (%)
Lungs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111843 (50.6%)
Liver /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111834 (40.0%)
Brain /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (21.2%)
HER2 IHC Results , n (%)
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188 (9.4%)
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111829 (34.1%)
ISH Positive /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (11.8%)
ISH Negative or NE /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (21.2%)
3+ /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111840 (47.1%)
Prior Anti-HER2 ADC Therapy , n (%) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111828 (32.9%)
Prior Anti-HER2 Antibody Therapy , n (%) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111847 (55.3%)
Prior Anti-HER2 TKI Therapy , n (%) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111835 (41.2%)
SOD in Target Lesion, median (n, range) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111855.0 (81,10.5-206.0)
Efficacy Data . As of January 13, 2023, a total of 52 patients had undergone at least one
post-baseline tumor scan. Overall, promising antitumor activity was observed in heavily
pretreated patients with HER2-expressing solid tumors with an uORR of 44.2% (23/52) and
DCR of 88.5% (46/52), as shown in the table below. Encouraging anti-tumor activity of
DB-1303 was observed in advanced BC patients, including 26 with HER2+ BC and 13 with
HER2-low BC. Antitumor activity of DB-1303 was also observed in non-BC tumor types,
including CRC, EC, OC and esophageal cancer.
ORR,% DCR,%
All patients (n=52) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111844.2 (23/52) 88.5 (46/52)
HER2+ BC (n=26) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111850 (13/26) 96.2 (25/26)
HER2+ BC with brain metastases (n=9) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111855.6 (5/9) 100 (9/9)
HER2 low BC (n=13) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111838.5 (5/13) 84.6 (11/13)
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The waterfall plot below sets forth the best tumor response for all patients with
post-baseline scans as of January 13, 2023.
Best Tumor Response by Subject ID
Dose Level
2.2mg/kg
6m g / k g
8m g / k g
4.4mg/kg
7m g / k g
10mg/kg
Best Change from Baseline (%)
-100
-50
0
100
50
150
HER2 IHC Status
1+
2+
3+
GEJ
BC
BC
CRC
EsC
NSCLC
OC
EC
GC
BC
BC
BC
BC
BC
BC
BC
BC
BC
BC
BC
BC
BC
BC
BC
BC
EC
BC
BC
BC
BC
EC
BC
CRC
CRC
BC
BC
BC
BC
BC
BC
BC
BC
BC
BC
EsC
BC
BC
BC
BC
OC
BC
+HSI
+HSI
+HSI
+HSI
+HSI
+HSI
+HSI
Subject name or identifier
201-001305-003101-004101-002104-001305-004102-001306-002202-004305-002301-014301-028306-007306-003301-018104-003301-019101-008301-020303-003306-005301-027101-007301-026101-005301-023305-008202-005301-025102-002307-003104-004101-003301-038301-001301-005301-004306-004301-002301-008302-001202-002202-003101-001301-010303-001301-009301-003101-006307-001301-012
The swimmer plot shows the tumor responses over time in all patients with post-baseline
scans.
Tumor Response Over Time
HER2 IHC Statu
1+
2+
3+
Response
PD
PR
SD
Dose Level 10 mg/kg8 mg/kg7 mg/kg6 mg/kg4.4 mg/kg2.2 mg/kg
Duration of Treatment (days)
Subject
104-004 CRC
202-003 BC
102-002 EC
202-004 GC
302-001 BC
301-018 BC
301-014 BC
306-005 BC
306-004 BC
305-008 GC
303-003 BC
301-027 BC
101-006 OC
101-007 BC
301-008 BC
306-003 BC
104-003 BC
301-010 BC
301-009 BC
101-005 EC
306-002 EC
301-012 BC
303-001 BC
301-038 BC
301-025 BC
307-001 BC
306-007 BC
202-005 BC
307-003 BC
301-023 BC
301-028 BC
301-026 BC
307-020 BC
301-032 BC
301-002 BC
301-004 BC
101-008 BC
101-003 CRC
301-003 BC
202-002 BC
301-001 BC
305-002 BC
305-004 NSCLC
301-005 BC
102-001 OC
305-003 BC
104-001 EsC
201-001 GEJ
101-004 BC
101-002 CRC
101-001 EsC
301-019 BC
150100500 250200
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The spider plot below sets forth the response with changes of tumor size in all patients
with post-baseline scans.
Tumor Response Over Change of Target Lesion
PR
PD
SD
2.2 mg/kg
4.4 mg/kg
6 mg/kg
7 mg/kg
8 mg/kg
10 mg/kg
3020100
Weeks since first dose of study drug
-100
-50
0
50
100
Change from Baseline (%)
BC
CRC
BC
BC
OC
EsC
BC
BC
BC
BC
BC
BC
BC
BC
BCEC
EC
BC
BC
BC
BC
BCBC
BC
BC
EC
EsC
GC
GEJ
BC
BC
BC
CRC
BC
BC
BC
BC
BC
BC BC
OC
BC
BC
BC
BC
BC
BC
CRC
SC
BC
Safety Data . DB-1303 was well tolerated and all AEs were manageable. As of January 13,
2023, no DLT was observed in all six dose levels during dose escalation and no TEAEs
associated with death occurred. TRAEs primarily included nausea, vomiting, platelet count
decreased, anemia, aspartate aminotransferase increased, decreased appetite, fatigue and
alanine aminotransferase increased, with grade 3 or above TRAEs reported in 12.9% (11/85)
of patients. Interstitial lung disease occurred in two patients (2.4%, both were grade 1). Few
patients experienced neutropenia (11.8% (10/85); grade 3 or above in 1.2% (1/85)) and
alopecia (3.5% (3/85), all were grade 1). The median duration of treatment was 63.0 (range,
21-211) days, and the median duration of follow-up was 77.0 (range, 7-350) days. The
following table sets forth a summary of the safety data as of January 13, 2023.
2.2 mg/kg
(n=1)
4.4 mg/kg
(n=5)
6.0 mg/kg
(n=15)
7.0 mg/kg
(n=29)
8.0 mg/kg
(n=32)
10.0 mg/kg
(n=3)
Total
(n=85)
Any TEAEs 1 (100.0%) 5 (100.0%) 14 (93.3%) 26 (89.7%) 26 (81.2%) 2 (66.7%) 74 (87.1%)
Associated with:
Treatment withdrawal 0 0 0 1 (3.4%) 0 0 1 (1.2%)
Treatment dose reduction 0 0 0 2 (6.9%) 1 (3.1%) 0 3 (3.5%)
Treatment dose interruption 0 0 4 (26.7%) 8 (27.6%) 5 (15.6%) 0 17 (20.0%)
Grade /H113503 0 3 (60.0%) 3 (20.0%) 9 (31.0%) 2 (6.2%) 1 (33.3%) 18 (21.2%)
Serious AEs 0 3 (60.0%) 4 (26.7%) 4 (13.8%) 2 (6.2%) 0 13 (15.3%)
Treatment-related TEAEs 1 (100.0%) 3 (60.0%) 12 (80.0%) 26 (89.7%) 25 (78.1) 2 (66.7%) 69 (81.2%)
Grade /H113503 0 1 (20.0%) 2 (13.3%) 6 (20.7%) 1 (3.1%) 1 (33.3%) 11 (12.9%)
Serious AEs 0 0 2 (13.3)% 0 0 0 2 (2.4%)
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The table below sets forth a summary of AEs occurring in /H1135020% of the patients and AESI.
TEAEs TRAEs AESI
All grade Grade /H113503 All grade Grade /H113503 All grade Grade /H113503
Nausea 44 (51.8%) 3 (3.5%) 42 (49.4%) 2 (2.4%) – –
V omiting 37 (43.5%) 1 (1.2%) 32 (37.6%) 0 – –
Platelet count decreased 30 (35.3%) 3 (3.5%) 30 (35.3%) 3 (3.5%) – –
Anemia 25 (29.4%) 5 (5.9%) 23 (27.1%) 5 (5.9%) – –
Aspartate aminotransferase increased 22 (25.9%) 0 21 (24.7%) 0 – –
Decreased appetite 22 (25.9%) 0 21 (24.7%) 0 – –
Fatigue 18 (21.2%) 1 (1.2%) 15 (17.6%) 0 – –
Alanine aminotransferase increased 17 (20.0%) 0 17 (20.0%) 0 – –
Ejection fraction decreased –––– 3 (3.5%) 0
Infusion related reaction –––– 2 (2.4%) 0
Interstitial lung disease –––– 2 (2.4%) 0
Electrocardiogram QT prolonged –––– 1 (1.2%) 0
Selected Preclinical Data
In preclinical studies in cynomolgus monkeys, DB-1303 showed reduced toxicity
compared to the published profile of DS-8201, enabling rapid systemic payload clearance in
monkeys. Highest non-severely toxic dose was 80 mg/kg, potentially translating to a large
safety margin.
DB-1303 also induced dose-dependent tumor growth inhibition and tumor regression,
demonstrating potent anti-tumor effect in both HER2+ and HER2 low tumor models with a
wide therapeutic window.
Tumor volume (mm3)
HER2 positive (HER2 2+)
PDX tumor model
Tumor volume (mm3)
HER2 low (HER2 1+)
PDX tumor model
1,000
800
600
400
200
0 7 14 21 280 7 14 21 28
Days post dosingDays post dosing
vehicle T-DM1, 7 mg/kg, single
dose
DB-1303, 2 mg/kg, single
dose
DB-1303, 7 mg/kg, single
dose
DS-8201*, 2 mg/kg,
single dose
DS-8201*, 7 mg/kg,
single dose
800
600
400
200
* An in-house produced analog of DS-8201.
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Material Communications with Competent Authorities
We received IND approval from the FDA in December 2021 and from the NMPA in April
2022, respectively, to investigate DB-1303 for advanced/metastatic solid tumors, pursuant to
which we initiated DB-1303’s phase 1/2a global clinical trial. Our phase 1/2a comprised two
standalone studies, namely, the phase 1 dose escalation study and the phase 2a dose expansion
study. The primary endpoints of the phase 1 dose escalation study were safety and tolerability,
including MTD/RP2D, whereas the primary endpoints of the phase 2a study were ORR and
safety endpoints. We completed the phase 1 dose escalation study of the phase 1/2a clinical
trial in January 2023, with all primary endpoints of this study reached, and initiated the phase
2a dose expansion study in the same month. For details, see “— Our Pipeline — ADC Assets
Developed from DITAC Technology Platform — DB-1303/BNT323, a late clinical-stage HER2
ADC candidate, our Core Product — Summary of Clinical Trial Data.”
Taking into account the industry practice as advised by Frost & Sullivan and as advised
by our PRC Legal Advisor with respect to PRC laws and regulations, the phase 1 dose
escalation study constituted a completed clinical trial with its main purpose aligning with the
overall purpose of a conventional phase 1 trial, which is typically to assess safety and
determine the dosage for phase 2 trial. Therefore, the completion of the phase 1 dose escalation
study is equivalent to the completion of a conventional phase 1 trial.
The INDs we obtained from the FDA and NMPA covered both the phase 1 dose escalation
study and the phase 2a dose expansion study. As advised by our PRC Legal Advisor, we are
not required to obtain additional approval or confirmation from the NMPA for commencing
phase 2a study of the phase 1/2a trial in China. Since initiating the phase 2a dose expansion
study, we have not received any material objection from the FDA or NMPA on the
commencement or progress of this study. Under the clinical trial design submitted to and
reviewed by the regulatory authorities for IND approval, our phase 2a study comprised of
multiple cohorts exploring the efficacy of DB-1303 in different cancer indications. Under
Measures for the Administration of Drug Registration () in China and
our IND from the NMPA, we are required to consult the CDE before commencing pivotal or
registrational studies, which we had duly fulfilled before initiating DB-1303’s phase 3
registrational trials for HR+/HER2- low BC and HER2+BC in China.
Since 2023, we have had several rounds of communications with the FDA and NMPA,
including EOP2 meetings for certain indications to seek feedback on the proposed clinical
development plans. For clarity, the initiation of DB-1303’s phase 3 registrational trial or
confirmatory trial is not contingent upon the completion of its ongoing phase 2a dose
expansion study. We are authorized to proceed with such phase 3 trials upon securing the
requisite regulatory confirmation, such as IND approvals (which we have obtained from the
NMPA for initiating DB-1303’s phase 3 registrational trials in HR+/HER2-low BC and
HER2+BC patients), or positive feedback at EOP2 meetings (which we have received from the
NMPA for DB-1303’s potential registrational study in HER2-expressing EC patients and
planned confirmatory trial in China). Specifically:
 For EC, an EOP2 meeting was held with the FDA in September 2023, where the
FDA (i) agreed to the conversion of DB-1303’s phase 2a dose expansion cohort in
HER2-expressing EC patients into a single arm study to support the filing of an
accelerated approval, and (ii) provided comments on the design of the planned
confirmatory trial for this indication, which will be used to support DB-1303’s full
marketing approval in the U.S.
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EOP2 meetings with the NMPA were also held in April 2024 for the same indication,
where the NMPA agreed that, in parallel to DB-1303’s clinical progress overseas, (i)
we should continue to advance DB-1303’s potential registrational study in HER2-
expressing EC patients in China, results from which may be used to support our
application for conditional approval in China for this indication, and (ii) a phase 3
confirmatory trial for the same indication will be required for DB-1303’s full
marketing approval post-conditional approval in China.
Unlike regular registrational trials conducted before marketing approval,
confirmatory trials are designed to verify a drug’s clinical benefits after it has
previously received accelerated or conditional approval and is already available to
patients. In the United States, China and many other jurisdictions, this
accelerated/conditional approval pathway allows promising therapies to reach
patients sooner, while still requiring robust evidence of long-term clinical benefit
through post-market studies before final marketing approvals are granted. For more
details on the regulatory pathways of accelerated approval (U.S.) and conditional
approval (China), see “Regulatory Overview — PRC Regulation — Regulations on
Pharmaceutical Product — Accelerated Approval for Clinical Trial and
Registration” and “Regulatory Overview — Overview of Laws and Regulations in
the United States — Laws and Regulations in Relation to New Drug — Expedited
Development and Review Programs.”
 For HR+/HER2-low BC, an EOP2 meeting with the FDA in September 2023 to seek
feedback on our planned phase 3 global registrational trial, and communicated with
the NMPA in November 2023 regarding the same matter. Based on communications
with the FDA in this meeting, DB-1303’s phase 3 registrational trial for HR+/HER2-
low BC was initiated in the United States. We received the NMPA’s IND approval
in March 2024 to commence DB-1303’s phase 3 registrational trial for HR+/HER2-
low BC in China.
 For HER2+ BC, we received the NMPA’s IND approval to conduct a phase 3
registrational trial in China and initiated this trial in 2024.
We did not receive any major concerns or objections from the abovementioned regulatory
authorities with respect to the clinical development plans for DB-1303. We and BioNTech will
continue to maintain close communications with competent authorities at key milestones of
DB-1303’s clinical development.
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The following table sets forth a summary of material communications with regulatory
authorities regarding DB-1303.
Milestone/Stage Timeline
Submission of IND application (phase 1/2a clinical trial) to
the FDA /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118November 2021
IND approval (phase 1/2a clinical trial) from the FDA (1) /H1118/H1118/H1118/H1118December 2021
Submission of IND application (phase 1/2a clinical trial) to
the NMPA /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118January 2022
IND approval (phase 1/2a clinical trial) from the NMPA (1) /H1118/H1118/H1118April 2022
Completion of the phase 1 study and initiation of phase 2a
study of phase 1/2a trial in advanced or metastatic solid
tumors /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118January 2023
Fast Track Designation from the FDA for the treatment of
advanced EC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118January 2023
EOP2 meeting with the FDA regarding EC indication to
discuss the conversion of DB-1303’s phase 2a dose
expansion cohort in EC patients into a single arm study to
support the filing of an accelerated approval, and seek
comments on the design of confirmatory study /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118September 2023
EOP2 meeting with the FDA regarding HR+/HER2-low BC
indication to seek feedback on our planned phase 3 global
registrational trial /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118September 2023
IND approval (HR+/HER2-low BC phase 3 global
registrational trial) from the FDA /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118September 2023
EOP2 meeting with the NMPA regarding HR+/HER2-low BC
indication to seek feedback on our planned phase 3 global
registrational trial /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118November 2023
Breakthrough Therapy Designation from the FDA for the
treatment of advanced EC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118December 2023
Breakthrough Therapy Designation by the NMPA for the
treatment of advanced EC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118March 2024
IND approval (HR+/HER2-low BC phase 3 global
registrational trial) from the NMPA /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118March 2024
IND approval (HER2+ BC phase 3 China registrational trial)
from the NMPA /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118April 2024
EOP2 meeting with the NMPA regarding the progress of DB-
1303’s potential registrational study in HER2-expressing EC
patients, the anticipated filing for conditional approval, and
planned confirmatory trial /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118April 2024
Note:
(1) In connection with the IND application, we submitted the trial protocol of DB-1303’s phase 1/2a clinical
trial, which set forth a detailed description of the study, including its purpose, the primary and secondary
objectives, patient selection criteria, and trial design, among other information. The FDA and NMPA
granted IND approval after reviewing the trial protocol we submitted and other information pertaining
to DB-1303’s development plan.
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DB-1303/BNT323 MAY NOT ULTIMATELY BE SUCCESSFULLY DEVELOPED AND
COMMERCIALIZED.
DB-1311/BNT324, a B7-H3 ADC candidate with global market potential, our Core Product
Overview
DB-1311 is an in-house discovered, clinically advanced B7-H3 ADC candidate under
global development. B7-H3 is a prominent member of the B7 family that plays a critical role
in promoting tumor progression and metastasis. DB-1311 is designed to harness the potential
of B7-H3 as a therapeutic target, leveraging its widespread overexpression in a broad range of
tumor types, including SCLC, NSCLC, CRPC, ESCC and HNSCC. Notably, DB-1311
demonstrates strong selectivity by targeting a specific isoform predominantly found on
B7-H3-overexpressing tumor cells, which, combined with its potent payload, stable linker-
payload and Fc-silenced mAb, potentially translates into a favorable safety profile and a wide
therapeutic window.
In collaboration with BioNTech, we are actively pursuing a comprehensive clinical
development plan to unlock the full potential of DB-1311, both as monotherapy and in
combination with immunotherapy. DB-1311 has shown preliminary efficacy signals and a
manageable safety profile in its ongoing phase 1/2a trial, including in patients with advanced
SCLC, CRPC and multiple other solid tumors. Preliminary data from this trial were presented
in an oral session at 2024 ESMO Asia. As of September 27, 2024, the data cut-off date for 2024
ESMO Asia, among all evaluable patients with at least one post-baseline tumor assessment
(n=238), the overall uORR was 32.4%, and the DCR was 82.4%. As of the same date, among
patients with SCLC (n=73), the uORR was 56.2%, and the DCR was 89.0%. Among patients
with CRPC (n=32), DB-1311 demonstrated early antitumor activity with a uORR of 28.0% and
a DCR of 92.0%; rPFS data were not yet mature, with a median rPFS of 7.2 months and a
6-month rPFS rate of 94.7%. Besides SCLC and CRPC, we are also investigating DB-1311’s
treatment potential in HNSCC, HCC, CC, and melanoma. In 2024, the FDA granted DB-1311
Fast Track Designation for the treatment of patients with advanced/unresectable, or metastatic
CRPC and Orphan Drug Designations for the treatment of ESCC and SCLC.
We entered into a license and collaboration agreement with BioNTech for DB-1311 in
March 2023, where we granted to BioNTech an exclusive, royalty-bearing and sublicensable
license under certain patents and know-how owned or otherwise controlled by us to develop,
manufacture, commercialize or otherwise exploit DB-1311 and pharmaceutical products
comprising DB-1311 (together “ DB-1311 Products ”) for all uses worldwide except Mainland
China, Hong Kong and Macau. We retain the full rights to develop, manufacture,
commercialize and otherwise exploit DB-1311 and DB-1311 Products in Mainland China,
Hong Kong and Macau. See “— Our Collaboration and Licensing Arrangements — License
and Collaboration Agreement with BioNTech for DB-1311/BNT324” for details.
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Drug Design and Mechanism of Action
B7-H3, also known as CD276, is a type I transmembrane protein belonging to the B7
family. Its overexpression has been observed in many solid tumors including lung, prostate,
esophageal, endometrial, and breast cancers, with limited expression in healthy tissues. The
high B7-H3 expression is also linked to disease progression and/or poor prognosis in many
cancer types. Due to its frequent expression in multiple tumors with high internalization
capability, B7-H3 has emerged as a promising target for ADC development. Several ADC
candidates are currently being studied in clinical trials and have showed manageable safety
profile and encouraging clinical efficacy in patients with various solid tumors.
DB-1311 is designed with three key components: a Fc-silenced, humanized anti-B7-H3
IgG1 mAb, a cleavable linker, and a proprietary DNA topoisomerase I inhibitor (P1021). The
core components of DB-1311 are illustrated below.
DB-1311
Humanized anti-B7-H3
IgG1 mAb
P1021
(TOP1 inhibitor)DAR = 6
DB-1311 is designed to deliver potent tumor killing while reducing off-target toxicities.
Conjugated at a higher DAR value of 6, DB-1311 showed more potent antitumor activity
compared to DS-7300 in vitro and in vivo in both high and medium B7-H3 expression models,
based on preclinical results published at the 2023 AACR Annual Meeting. DB-1311
demonstrated high selectivity by targeting the 4IgB7-H3 isoform, which is predominantly
found on B7-H3-overexpressing tumor cells, with over 1,000-fold greater affinity compared to
the 2IgB7-H3 isoform commonly expressed on normal cells. This high selectivity differentiates
DB-1311 and aims to enable the delivery of DB-1311’s payload directly into tumor cells.
Meanwhile, DB-1311’s Fc-silenced mAb is designed to reduce unwanted immune responses. In
preclinical studies, DB-1311 has shown a significantly higher HNSTD and better binding to
B7-H3-expressing lung cancer cells compared to DS-7300.
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Market Opportunity and Competition
As of the Latest Practicable Date, there were no approved B7-H3-targeted therapies,
including ADCs, globally or in China, and there were six B7-H3 ADCs under global MRCTs.
For more details on the competitive landscape of B7-H3 ADCs, see “Industry Overview —
Global B7-H3 ADC Market — Market Opportunities of B7-H3 ADCs.” For details of the key
features of DB-1311 in comparison with other B7-H3 ADCs, see also “Industry Overview —
Global B7-H3 ADC Market — Competitive Landscape.”
To compete effectively in the B7-H3 ADC markets, we are actively pursuing a
comprehensive clinical development plan to unlock the full potential of DB-1311, with a
strategic focus on SCLC and CRPC. DB-1311 is also designed to deliver potent tumor killing
while reducing off-target toxicities, which differentiates DB-1311 with its competitors in the
B7-H3 ADC markets.
SCLC. Lung cancer is the most common cancer and the leading cause of cancer death
worldwide. SCLC represents 10-15% of all lung cancer cases globally. The global incidence of
SCLC increased from 332.9 thousand cases in 2018 to 382.8 thousand cases in 2023, and is
projected to reach 484.1 thousand cases by 2032. In China, incidence of SCLC increased from
142.7 thousand cases in 2018 to 163.5 thousand cases in 2023, and is projected to reach 202.1
thousand cases by 2032. As a highly aggressive cancer, the average five-year survival rate for
SCLC patients in extensive stage is less than 5%.
Chemotherapy is still the mainstay for SCLC treatment. However, SCLC patients often
develop resistance to chemotherapy and the disease often relapses within one year. Relapsed
SCLC patients often have worse prognosis, with limited treatment options available. While
immunotherapies such as PD-(L)1 inhibitors are recommended in frontline settings for
extensive stage SCLC patients, there remains a unmet need for new and more effective
treatments for SCLC patients. For details of the treatment paradigm of SCLC in China and the
U.S., see “Industry Overview — Global B7-H3 ADC Market — Market Opportunities of
B7-H3 ADCs — Small-cell Lung Cancer.”
As of the Latest Practicable Date, no B7-H3 targeted therapies, including ADCs, had been
approved for SCLC globally. As of the same date, there were nine B7-H3 ADCs targeting
SCLC under clinical development globally. For details, see “Industry Overview — Global
B7-H3 ADC Markets — Competitive Landscape.”
CRPC. CRPC is a severe form of prostate cancer that exhibits resistance to treatments
aiming to reduce testosterone levels. Among the subtypes of CRPC, mCRPC is particularly
advanced and challenging. The global incidence of mCRPC increased from 176.4 thousand
cases in 2018 to 203.9 thousand cases in 2023, and is projected to reach 244.8 thousand cases
by 2032. The incidence of mCRPC in China increased from 42.8 thousand cases in 2018 to 50.5
thousand cases in 2023, and is projected to reach 72.2 thousand cases by 2032.
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The current treatment paradigm for CRPC remains limited in its ability to provide durable
and effective long-term control. Drug resistance remains a critical challenge in the treatment
of mCRPC. While androgen deprivation therapy (“ ADT”) like enzalutamide and abiraterone
provide initial benefits, most patients eventually develop resistance, leading to disease
progression, underscoring the potential of innovative targeted therapy to address this unmet
need. For details of the treatment paradigm of CRPC in China and the U.S., see “Industry
Overview — Global B7-H3 ADC Market — Market Opportunities of B7-H3 ADCs —
Castration-resistant Prostate Cancer.”
As of the Latest Practicable Date, no B7-H3 targeted therapies, including ADCs, had been
approved for CRPC globally. As of the same date, there were six B7-H3 ADCs targeting CRPC
under clinical development globally. For details, see “Industry Overview — Global B7-H3
ADC Markets — Competitive Landscape.”
We and BioNTech are also actively exploring DB-1311’s therapeutic potential across
several prevalent cancer types under-explored by other clinical-stage B7-H3 ADCs. On July 16
and August 26, 2024, DB-1311 was granted Orphan Drug Designations by the FDA as a
treatment for ESCC and SCLC, respectively.
Key Advantages
 Key player in the global B7-H3 ADC landscape. Despite the current absence of
approved B7-H3-targeted therapies, B7-H3 ADCs have demonstrated encouraging
clinical efficacy, notably in SCLC patients, sparking substantial interest and
high-profile licensing deals in the field, according to Frost & Sullivan. These
developments underscore the potential of B7-H3 ADCs to improve cancer patient
outcomes.
DB-1311 is currently one of the top three B7-H3 ADCs undergoing global MRCTs
in terms of clinical development progress for advanced SCLC, according to Frost &
Sullivan. SCLC is an aggressive form of lung cancer characterized by rapid growth
and high rates of recurrence with a five-year survival rate of less than 7%, compared
to 28% for NSCLC. However, available treatments for SCLC remain limited,
primarily to chemotherapy and PD-L1 inhibitors, with few targeted therapies
approved globally for this indication to date. The global SCLC drug market is
expected to increase from US$4.1 billion in 2023 to US$7.6 billion by 2028,
representing a CAGR of 13.0%, according to Frost & Sullivan.
We are also investigating DB-1311’s potential in treating CRPC patients, another
cancer population that is highly underserved. To date, there are no B7-H3 ADC
candidates indicated for CRPC that have entered into phase 3 registrational trial
worldwide, according to Frost & Sullivan. In June 2024, DB-1311 was granted Fast
Track Designation by the FDA for the treatment of patients with
advanced/unresectable, or metastatic CRPC who have progressed on or after
standard systemic regimens, in recognition of DB-1311’s potential for the treatment
of this challenging tumor type. While patients with metastatic prostate cancer
initially respond to hormone therapy, most patients progress after 18-24 months and
develop mCRPC, leading to a poor prognosis. The global CRPC drug market is
expected to increase from US$3.9 billion in 2023 to US$6.5 billion by 2028,
representing a CAGR of 10.9%, according to Frost & Sullivan.
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 Novel design with the potential to enable tumor killing and wide therapeutic
window. DB-1311 is designed to deliver potent tumor killing while reducing
off-target toxicities. Conjugated at a higher DAR value of 6, DB-1311 showed more
potent antitumor activity compared to DS-7300 in vitro and in vivo in both high and
medium B7-H3 expression models, based on preclinical results published at the
2023 AACR Annual Meeting. DB-1311 demonstrated high selectivity by targeting
the 4IgB7-H3 isoform, which is predominantly found on B7-H3-overexpressing
tumor cells, with over 1,000-fold greater affinity compared to the 2IgB7-H3 isoform
commonly expressed on normal cells. This high selectivity differentiates DB-1311
and aims to enable the delivery of DB-1311’s payload directly into tumor cells.
Meanwhile, DB-1311’s Fc-silenced mAb is designed to reduce unwanted immune
responses. In preclinical studies, DB-1311 has shown a significantly higher HNSTD
and better binding to B7-H3-expressing lung cancer cells compared to DS-7300.
 Promising clinical efficacy and manageable safety profile observed in phase 1/2a
trial. DB-1311 showed encouraging antitumor activity in its phase 1/2a global trial
in advanced solid tumors. Preliminary data from this trial were presented in an oral
session at 2024 ESMO Asia. As of September 27, 2024, the data cut-off date for
2024 ESMO Asia, among all evaluable patients with at least one post-baseline tumor
assessment (n=238), the overall uORR was 32.4%, and the DCR was 82.4%. As of
the same date, among patients with SCLC (n=73), the uORR was 56.2%, and the
DCR was 89.0%. Among patients with CRPC (n=32), DB-1311 demonstrated early
antitumor activity with a uORR of 28.0% and a DCR of 92.0%; rPFS data were not
yet mature, with a median rPFS of 7.2 months and a 6-month rPFS rate of 94.7%.
We are also investigating DB-1311’s treatment potential in several prevalent cancer
types under-explored by other clinical-stage B7-H3 ADCs. Preliminary data from
DB-1311’s phase 1/2a global trial also showed an acceptable and manageable safety
profile, with low rates of TRAEs associated with drug discontinuation, dose
reduction, drug interruption or death.
 Combination potential as frontline treatment for prevalent cancers. We believe the
combination of DB-1311 with immunotherapy holds therapeutic promise, as the
direct cytotoxic effects of this B7-H3 ADC synergize with the immune-activating
properties of immunotherapies, potentially leading to a more powerful anti-tumor
response and improved patient outcomes. We are actively exploring DB-1311’s
combination potential to expand into earlier treatment lines in various solid tumors,
such as CRPC, SCLC and NSCLC. For example, DB-1311 is currently undergoing
a phase 1b/2 trial in combination with BNT327, a bsAb targeting PD-L1 and VEGF,
in patients with advanced lung cancer, including SCLC and NSCLC.
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 Opt-in rights to co-develop and co-commercialize in the U.S. Under our
collaboration agreement with BioNTech, we have retained an option to co-develop
and co-commercialize DB-1311 in the U.S. If we elect to exercise this option, we
will become eligible to share the profits/losses and costs from DB-1311’s
development and commercialization in this major market. This strategic partnership
not only demonstrates our confidence in and commitment to DB-1311’s global
development, but also allows us to leverage BioNTech’s complementary strengths
and resources while capturing the asset’s significant economic interest and upside
potential overseas. As such, we are well-positioned to efficiently navigate the
complex global market landscape and accelerate DB-1311’s entry into both domestic
and international markets.
Clinical Development Plan
Based on IND approvals from the FDA and the NMPA, we initiated a phase 1/2a global
trial for DB-1311 for patients with advanced/metastatic solid tumors in September 2023 and
were the sponsor of this trial as of the Latest Practicable Date. As the first-in-human study for
DB-1311, this phase 1/2a clinical trial provides foundational data that informs our regulatory
discussions with the competent authorities and shapes our late-stage clinical development
strategy. We completed the phase 1 study of this phase 1/2a trial in March 2024.
We are focused on DB-1311’s strategic positioning as one of the top three B7-H3 ADCs
undergoing global MRCTs in terms of clinical development progress for advanced SCLC,
according to Frost & Sullivan. Leveraging DB-1311’s Fast Track Designation from the FDA,
we are also actively exploring DB-1311’s potential in CRPC. We and BioNTech will continue
to advance the phase 2a dose expansion study of DB-1311’s phase 1/2a trial in cancer types
under-explored by other clinical-stage B7-H3 ADC candidates. In general, if approved,
DB-1311 with different indications would be regulated as the same product by each competent
authority.
The table below sets forth the drug development timeline for DB-1311.
Milestone/Stage Timeline
Preclinical development /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118May 2021 to May 2023
License and collaboration agreement with BioNTech /H1118March 2023
IND approval from FDA /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118May 2023
IND approval from NMPA /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118August 2023
Phase 1/2a clinical trial in advanced or metastatic
solid tumors /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Start date:
September 2023
Completion date:
Phase 1: March 2024
Phase 2a: 2026 (planned)
Data readout from phase 1/2a trial and oral
presentation at ESMO Asia /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
December 2024
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Summary of Clinical Trial Data
Phase 1/2a Clinical Trial in Patients with Advanced/Metastatic Solid Tumors ( NCT05914116 )
This is a phase 1/2a, multicenter, open label, first in human study to assess the safety,
tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1311 in patients with
advanced/metastatic solid tumors who progressed on previous standard therapies or for whom
no standard therapy is available.
Trial Design . This trial consists of two parts: phase 1 dose escalation study and phase 2a
dose expansion study. Phase 1 adopts an accelerated titration at first dose level (3 mg/kg)
followed with classic “3+3” design (6, 9, 12 and 15 mg/kg) given intravenous Q3W to identify
the MTD and/or RP2D. Phase 2a is a dose expansion phase to confirm the safety, tolerability
and explore efficacy in selected malignant solid tumors treated with DB-1311 as monotherapy.
Trial Objectives . The primary objective of the phase 1 dose escalation study is to evaluate
safety and tolerability and determine the MTD/RP2D. The primary endpoints of the phase 1
study are safety and tolerability measured by DLTs, SAEs, TEAEs, MTD and/or RP2D.
Secondary endpoints include efficacy (measured by ORR, DoR, DCR, TTR, PFS, OS), PK, and
immunogenicity.
The primary objective of the phase 2a dose expansion study is to assess safety and
tolerability of DB-1311 at the MTD/RP2D and evaluate the efficacy of DB-1311 at the
MTD/RP2D. The primary endpoints of the phase 2a study are SAEs, TEAEs and ORR as
determined by investigator. Secondary endpoints include efficacy (measured by DoR , DCR,
TTR, PFS, OS, among others), PK, and immunogenicity.
Trial Progress . The phase 1 dose escalation study was initiated in September 2023 and
completed in March 2024, with all primary endpoints met. Phase 2a dose expansion study is
currently ongoing. Preliminary data from this trial were presented in an oral session at 2024
ESMO Asia.
As of September 27, 2024, the data cut-off date for 2024 ESMO Asia, there were 277
evaluated patients across various solid tumor types including SCLC, NSCLC, CRPC, and
squamous cell carcinoma of the head and neck (“SCCHN”). About 75% of participants had an
Eastern Cooperative Oncology Group (“ECOG”) performance status of 1, and approximately
61% had undergone two or more lines of therapy.
Efficacy Data. DB-1311 shows encouraging antitumor activity across heavily pre-treated
patients with locally advanced or metastatic solid tumors. As of September 27, 2024, among
all evaluable patients with at least one post-baseline tumor assessment (n=238), the overall
uORR was 32.4% and the DCR was 82.4%.
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Among patients with SCLC (n=73), the uORR was 56.2%, and the DCR was 89.0%. The
majority of patients with SCLC received 6 mg/kg and 9 mg/kg of DB-1311, with no significant
difference in uORR between the two dose groups (54.5% and 58.8%, respectively).
Most patients with NSCLC had non-squamous histology (n=41), exhibiting a uORR of
22.0%, while patients with squamous NSCLC (n=25) had a uORR of 16.0%.
Among patients with CRPC (n=32), DB-1311 demonstrated early antitumor activity with
a uORR of 28.0% and a DCR of 92.0%. rPFS data were not yet mature, with a median rPFS
of 7.2 months and a 6-month rPFS rate of 94.7%.
In other tumor types, including CC (n=4), HCC (n=12), HNSCC (n=3), and melanoma
(n=11), DB-1311 also exhibited antitumor activity with uORRs of 75.0%, 25.0%, 100.0%, and
36.4%, respectively.
Safety Data. DB-1311 showed a manageable safety profile across all evaluated patients
and tumor types (n=277) as of September 27, 2024. The most common TRAEs reported
included nausea, neutrophil count decreased, anemia, white blood cell count decreased,
decreased appetite, and platelet count decreased.
Material Communications with Competent Authorities
We received IND approvals from the FDA and the NMPA in May 2023 and August 2023,
respectively, to investigate DB-1311 for advanced/metastatic solid tumors, pursuant to which
we initiated DB-1311’s phase 1/2a global clinical trial in advanced/metastatic solid tumors.
Our phase 1/2a comprised two standalone studies, namely, the phase 1 dose escalation study
and the phase 2a dose expansion study. The primary endpoints of the phase 1 dose escalation
study were safety and tolerability, including MTD/RP2D, whereas the primary endpoints of the
phase 2a study were ORR and safety endpoints. We completed the phase 1 dose escalation
study of the phase 1/2a clinical trial in March 2024, with all primary endpoints of this study
reached. For details, see “— Our Pipeline — ADC Assets Developed from DITAC Technology
Platform — DB-1311/BNT324, a B7-H3 ADC candidate with global market potential, our Core
Product — Summary of Clinical Trial Data.”
Taking into account the industry practice as advised by Frost & Sullivan and as advised
by our PRC Legal Advisor with respect to PRC laws and regulations, the phase 1 dose
escalation study constituted a completed clinical trial with its main purpose aligning with the
overall purpose of a conventional phase 1 trial, which is typically to assess safety and
determine the dosage for phase 2 trial. Therefore, the completion of the phase 1 dose escalation
study is equivalent to the completion of a conventional phase 1 trial.
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As advised by our PRC Legal Advisor, we are not required to obtain additional approval
or confirmation from the NMPA for commencing phase 2a study of the phase 1/2a trial in
China. This is because we have obtained an IND approval to conduct DB-1311’s phase 1/2a
trial in its entirety, which covers both the phase 1 dose escalation study and the phase 2a dose
expansion study. Furthermore, the FDA explicitly stated in its IND approval that we may
proceed with our clinical investigation based on the clinical protocol for the entire phase 1/2a
trial.
We did not receive any major concerns or objections from the abovementioned regulatory
authorities to the clinical development plans for DB-1311. We and BioNTech plan to maintain
close communications with the competent authorities at key milestones of DB-1311’s clinical
development, including before initiating any phase 3 registrational studies and combination
trials.
The following table sets forth a summary of material communications with regulatory
authorities regarding DB-1311.
Milestone/Stage Timeline
Submission of IND application (phase 1/2a clinical trial) to
the FDA (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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
April 2023
Submission of IND application (phase 1/2a clinical trial) to
the NMPA (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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
June 2023
IND approval (phase 1/2a clinical trial) from the FDA /H1118/H1118/H1118/H1118/H1118/H1118May 2023
IND approval (phase 1/2a clinical trial) from the NMPA /H1118/H1118/H1118/H1118/H1118August 2023
Fast Track Designation from the FDA for the treatment of
advanced CRPC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
June 2024
Orphan Drug Designation from the FDA for the treatment
of ESCC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
July 2024
Orphan Drug Designation from the FDA for the treatment
of SCLC /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
August 2024
Note:
(1) In connection with the IND application, we submitted the trial protocol of DB-1311’s phase 1/2a clinical trial,
which set forth a detailed description of the study, including its purpose, the primary and secondary objectives,
patient selection criteria, and trial design, among other information. The FDA and NMPA granted IND
approval after reviewing the trial protocol we submitted and other information pertaining to DB-1311’s
development plan.
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DB-1311/BNT324 MAY NOT ULTIMATELY BE SUCCESSFULLY DEVELOPED AND
COMMERCIALIZED.
DB-1310, a HER3 ADC candidate in phase 1/2a trial, our key product
Overview
DB-1310 is our self-discovered HER3 ADC and one of the world’s most clinically
advanced HER3 ADC candidates, according to Frost & Sullivan, for which we hold global
rights. HER3, along with EGFR and HER2, are growth factor receptors in the HER family that
play crucial roles in tumor survival and growth. Despite the growing research and clinical
interest in HER3, it remains under-explored and has faced two decades of drug development
challenges due to the complexity in achieving signaling inhibition and the potential for escape
pathway activation. Guided by our team of leading experts in HER3 research, we have built a
deep knowledge base in HER3 biology, including its dimerization patterns and intricate
interactions with EGFR and HER2, and its involvement in resistance mechanisms. These
insights have informed DB-1310’s innovative design and equipped it with a high
internalization capability to deliver payloads directly into HER3-expressing cancer cells,
which leads to targeted tumor killing and improved therapeutic outcomes.
We believe HER3 ADCs present opportunities to cover a broad patient population and
overcome resistance to standard of care. We have developed a rational and differentiated
clinical development strategy focused on carefully selected indications that maximize its
commercial potential. Building on DB-1310’s preliminary efficacy observed as a late-line
monotherapy for EGFRm NSCLC, we have taken a differentiated strategy to investigate its
combination potential with osimertinib in EGFRm NSCLC patients, with opportunity as
first-line treatment to cover a broader patient population. DB-1310 is also one of the few global
clinical-stage HER3 ADCs being investigated as a potential treatment for KRASm NSCLC. We
are also exploring the efficacy signals of DB-1310 in various other solid tumors, including BC,
CRPC, HNSCC, ESCC and BTC.
Drug Design and Mechanism of Action
HER3 is a member of the HER family that plays a crucial role in the development and
progression of various types of cancer. In contrast to EGFR and HER2, HER3 is the only
family member of the HER family that lacks an active kinase domain, which makes it an
obligate binding partner with other receptors for its oncogenic role. Despite lacking intrinsic
tyrosine kinase activity, HER3 is activated by dimerization with another receptor, with EGFR
and HER2 being its preferred dimerization partners. Moreover, ubiquitous HER3 expression is
detected in various solid tumors, including breast, lung, colorectal, prostate, and head and neck
cancers. High HER3 expression is also associated with a more aggressive disease, increased
metastatic potential, and poorer clinical outcomes for patients.
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Unlike traditional inhibitors that depend on blocking HER3’s signaling pathway, ADCs
leverage HER3’s presence on tumor cells to deliver highly potent cytotoxic payloads to
directly kill tumor cells. Enhanced antibody engineering significantly improves DB-1310’s
internalization efficiency, while its bystander killing effect enables elimination of neighboring
cancer cells regardless of their HER3 expression levels. This combination of targeted delivery,
improved internalization, and bystander activity makes DB-1310 a promising “all-comer”
therapeutic opportunity that addresses diverse patient populations across multiple tumor types
without requiring specific biomarker selection.
Activation of HER3 through dimerization promotes pro-survival and pro-proliferative
signaling pathways, making it an attractive therapeutic target in oncology. HER3 expression
also acts as a bypass mechanism for various targeted therapies.
DB-1310 is a HER3-targeted ADC designed with a highly potent topoisomerase I
inhibitor payload P1021, a cleavable linker containing tetrapeptide and a novel humanized
anti-HER3 IgG1 monoclonal antibody. The core components of DB-1310 are illustrated below.
DB-1310
Humanized anti-HER3
IgG1 mAb
P1021
(TOP1 inhibitor)DAR = 8
DB-1310’s antibody is designed to bind to a novel epitope on the domain I of HER3.
Upon binding and internalization into the target tumor cell, the ADC is cleaved by lysosomal
enzymes, releasing the P1021 payload in the cytoplasm. The P1021 payload prevents
re-ligation of the DNA strand by binding to topoisomerase I-DNA complex, and causes
double-strand DNA breakage and cancer cell death. DB-1310 is designed with a DAR of 8,
enabling a high concentration of the cytotoxic agent to be delivered to the tumor cell. In
preclinical studies, DB-1310’s mAb demonstrated higher affinity for HER3 compared to
patritumab (the antibody used in U3-1402) and was more effectively internalized.
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Market Opportunity and Competition
As of the Latest Practicable Date, there were no approved HER3-directed therapies,
including ADCs, globally or in China, and there were four HER3 ADC candidates under global
MRCTs. For more details on the competitive landscape of HER3 ADCs, see “Industry
Overview — Global HER3 ADC Market — Market Opportunities of HER3 ADCs.” For details
of the key features of DB-1310 in comparison with other HER3 ADCs, see also “Industry
Overview — Global HER3 ADC Market — Competitive Landscape.”
To compete effectively in the HER3 ADC markets, we have built a deep knowledge base
in HER3 biology, including its dimerization patterns and intricate signaling crosstalk with
EGFR and HER2, and its involvement in resistance mechanisms. These insights have informed
DB-1310’s innovative design and equipped it with a high internalization capability to deliver
payloads directly into HER3-expressing cancer cells, which leads to targeted tumor killing and
improved therapeutic outcomes. We are currently developing DB-1310 for multiple subtypes of
NSCLC and BC and may further expand to other solid tumors such as CRPC.
NSCLC. NSCLC is the most common subtype of lung cancer and represents
approximately 85% of all lung cancer cases globally. Global incidence of NSCLC cases
increased from 1,886.3 thousand cases in 2018 to 2,169.4 thousand cases in 2023 and is
projected to reach 2,614.2 thousand cases by 2030. In China, NSCLC incidence increased from
808.7 thousand cases in 2018 to 926.6 thousand cases in 2023, and is projected to reach 1,100.0
thousand cases by 2030.
EGFRm NSCLC is a prevalent subtype of NSCLC with approximately 700 thousand new
cases each year globally. EGFR mutations are particularly prevalent in the Asian population,
accounting for over 50% of all NSCLC cases in this demographic group.
In China and the U.S., the first-line treatment for EGFRm NSCLC patients include TKIs,
such as afatinib, erlotinib, dacomitinib, gefitinib and osimertinib. However, most of these
patients eventually acquire resistance with median relapse occurring approximately 9-14
months after treatment with TKIs. For patients who have failed TKIs, effective treatment
options are limited, which primarily include platinum-based doublet chemotherapy with or
without bevacizumab (VEGF mAb), single-agent chemotherapy, or PD-(L)1 inhibitors. For
details of the treatment paradigm of EGFRm NSCLC in China and the U.S., see “Industry
Overview — Global HER3 ADC Market — Market Opportunities of HER3 ADCs —
Non-small Cell Lung Cancer — EGFR-mutant NSCLC.”
HER3 has become a validated target for EGFRm NSCLC, supported by promising
efficacy data shown in pivotal trials. EGFR and HER3 can together form heterodimeric
complexes, leading to the activation of downstream signaling pathways. HER3 is also shown
to be an escape mechanism involved in resistance to EGFR TKI therapies.
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BC. The global incidence of BC increased from 2,088.8 thousand cases in 2018 to 2,408.0
thousand in 2023, and is projected to reach 3,195.7 thousand cases by 2032. HER3-
overexpression is reported in 18-43% of BC patients.
While HER2 is a well-established target for BC treatments, approximately 15-40% of all
BC cases are HER2 null, which show limited response to current HER2-targeted therapies. In
addition, HER2-expressing BC commonly exhibit co-expression and activation of HER3.
Inhibition of HER2 can lead to a compensatory upregulation or activation of HER3, which can
limit the efficacy of HER2-targeted therapies, including HER2 ADCs such as Enhertu
®. This
feedback loop between the two receptors highlights the importance of developing HER3-
targeted therapies to overcome potential resistance to HER2-targeted therapies. For details of
the treatment paradigm of BC in China and the U.S., see “Industry Overview — Global HER3
ADC Market — Market Opportunities of HER3 ADCs — Breast Cancer.”
Key Advantages
 Differentiated EGFRm NSCLC strategy. DB-1310 is a global clinical-stage HER3
ADC candidate being developed for EGFRm NSCLC patients resistant to
osimertinib or other third-generation TKI treatments, according to Frost & Sullivan.
DB-1310 demonstrated promising anti-tumor activity as a single agent in patients
with advanced or metastatic EGFRm NSCLC who failed previous standard therapies
in the dose escalation cohort of its phase 1/2a clinical trial. We are also developing
DB-1310 in combination with osimertinib based on our translational medicine
research that EGFR inhibition synergistically promotes HER3 ADC internalization
and efficacy. Preclinical studies demonstrate more potent anti-tumor activity from
DB-1310 and osimertinib combination therapy than either DB-1310 or osimertinib
as monotherapy. We are enrolling patients in our phase 1 global dose escalation
study for DB-1310 in China and the U.S.
 Unique coverage of KRASm NSCLC. KRAS mutations are estimated to occur in
approximately 30% of NSCLC cases. There are currently no global registrational
trials for HER3 ADC candidates specifically targeting KRASm NSCLC,
highlighting the potential of DB-1310 in this underserved area. Patients with
KRASm NSCLC typically experience rapid disease progression after KRAS TKI
treatments, and those who develop drug resistance face severely limited subsequent
treatment options. We have observed preliminary efficacy in KRASm NSCLC
patients, including partial response in dose expansion, in DB-1310’s phase 1/2a
global trial.
 Encouraging efficacy in multiple BC subtypes. DB-1310 has demonstrated efficacy
signals as a single agent across multiple BC subtypes, including for HER2+ BC and
HR+/HER2-low BC, and in TNBC patients with prior Trodelvy ® treatment.
Furthermore, DB-1310 in combination with trastuzumab has significant potential to
treat HER2-expressing BC patients with prior Enhertu
® treatment, given HER3’s
critical role in drug resistance and pathway synergies with HER2.
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 Treatment potential for CRPC. HER3 protein is frequently overexpressed in prostate
cancer, correlating with faster progression to castration resistance and reduced
overall survival. In preclinical studies, DB-1310 has demonstrated significant
antitumor activity against prostate cancer, indicating its potential as a promising
treatment for this cancer type. We are currently recruiting patients with CRPC in
DB-1310’s phase 1/2a trial.
 Promising preliminary data from phase 1/2a trial. DB-1310 demonstrated promising
anti-tumor activity as a single agent in patients with advanced or metastatic EGFRm
NSCLC who failed previous standard therapies in the dose escalation cohort of its
phase 1/2a clinical trial. In EGFRm NSCLC patients, as of May 17, 2024, uORR and
DCR reached 39% and 94.4%, respectively, across dose levels from 1.5 to 5.5
mg/kg. The uORR and DCR was 50% and 100% at 4.5 mg/kg, respectively, and
100% and 100% at 5.5 mg/kg, respectively. DB-1310 also demonstrated an
acceptable and manageable safety profile in its phase 1/2a global trial. As of May
17, 2024, the incidence of grade 3 or above TRAEs was 19.3%.
Summary of Clinical Trial Data
We received IND approvals from the FDA and NMPA in March 2023 and May 2023,
respectively, and commenced DB-1310’s first-in-human global MRCT phase 1/2a clinical trial
for advanced/metastatic solid tumors. Set forth below is a summary of the key information on
DB-1310’s ongoing clinical trial.
Phase 1/2a Clinical Trial in Patients with Advanced/Metastatic Solid Tumors (NCT05785741)
This is a phase 1/2a, multicenter, open-label, non-randomized first-in-human study to
assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of
DB-1310 in patients with advanced/metastatic solid tumors who failed previous standard
therapies or no standard therapy is available, regardless of HER3 expression.
Trial Design . This trial consists of two parts: a phase 1 dose escalation study and phase
2a dose expansion study, with approximately 1,000 patients expected to be enrolled. The phase
1 study has three arms: (i) DB-1310 monotherapy (solid tumors), using a classic “3+3” design
with six dose levels, (ii) DB-1310 combo-therapy A (HER2+ BC), combining DB-1310 with
trastuzumab, and (iii) DB-1310 combo-therapy B (NSCLC with EGFR Ex19del or L858R
mutation), combining DB-1310 with osimertinib. Each arm of the phase 1 study adopts a “3+3”
dose escalation design to identify: the MTD and/or RP2D of DB-1310 as monotherapy, the
recommended combination dose A (“ RCD_A ”) of DB-1310 in combination with trastuzumab
and the recommended combination dose B (“ RCD_B ”) of DB-1310 in combination with
osimertinib.
Phase 2a study expands into multiple cohorts of advanced/metastatic solid tumors, each
exploring specific subtypes and/or combinations, to further assess the efficacy and safety of
DB-1310.
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Trial Objectives . The primary objective of the phase 1 dose escalation study is to assess
safety and tolerability of DB-1310 as monotherapy or in combination with trastuzumab or in
combination with osimertinib, and to determine the MTD/RP2D of DB-1310 as monotherapy
or the RCD_A of DB-1310 in combination with trastuzumab or the RCD_B of DB-1310 in
combination with osimertinib. The primary endpoints of the phase 1 study are safety and
tolerability measured by DLTs, SAEs, TEAEs, MTD and/or RP2D, among others. Secondary
endpoints include efficacy (measured by ORR, DoR, DCR, TTR, PFS, OS per RECIST v1.1),
PK, and immunogenicity.
The primary objective of the phase 2a dose expansion study is to assess the safety and
tolerability of DB-1310 as monotherapy or in combination with trastuzumab or in combination
with osimertinib in targeted subject populations, and to assess the effectiveness of DB-1310 as
monotherapy or in combination with trastuzumab or in combination with osimertinib by
assessment of ORR by investigator. The primary endpoints of the phase 2a study are SAEs,
TEAEs and ORR. Secondary endpoints include efficacy (measured by DoR, DCR, TTR, PFS
or rPFS, OS, PSA50 response rate, PSA-PFS for mCRPC per RECIST v1.1), PK, and
immunogenicity.
Trial Progress . The phase 1 dose escalation study was initiated in April 2023 and is
currently recruiting patients. As of May 17, 2024, the data cut-off date of the preliminary phase
1 results, 57 subjects from the DB-1310 monotherapy arm received at least one dose of
DB-1310.
Efficacy Data . As of May 17, 2024, of the 18 efficacy-evaluable EGFRm NSCLC
patients, DB-1310 achieved a uORR of 39% (7/18) and DCR of 94.4% (17/18) across all dose
levels from 1.5 to 5.5 mg/kg. The chart below sets forth the best tumor response for all patients
across various tumor types.
Best Tumor Response for Patients with Post-baseline Scans
Dose Level 1.5 mg/kg 3 mg/kg 4.5 mg/kg 5 mg/kg 5.5 mg/kg 6.5 mg/kg
100
50
0
-50
-100
Best Change from Baseline (%)
Other
NSCLC
NSCLC
HER2+ BC
HR+HER2-BC
TNBC
Other
Other
NSCLC
Other
TNBC
NSCLC
NSCLC
Other
NSCLC
Other
TNBC
Other
NSCLC
HR+HER2-BC
NSCLC
NSCLC
NSCLC
NSCLC
TNBC
NSCLC
NSCLC
NSCLC
NSCLC
NSCLC
Other
NSCLC
NSCLC
NSCLC
NSCLC
NSCLC
NSCLC
NSCLC
NSCLC
NSCLC
NSCLC
NSCLC
NSCLC
Other
TNBC
Subject
104-009103-005102-004205-001109-002201-005106-004106-002201-006105-003104-005106-010106-001201-007104-006102-001101-003202-001106-009201-003105-005105-008201-008104-001106-006104-004103-007205-002104-010105-007103-003202-002201-004105-003101-001103-002103-001103-008104-007101-002105-001204-002204-001103-004
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Tumor shrinkage with durable response was observed in various tumor types. The two
charts below set forth the tumor response over time for patients with post-baseline scans and
target lesion tumor response over time for patients with post-baseline scans as of May 17, 2024.
Tumor Response Over Time for Patients with Post-baseline Scans
1.5 mg/kgDose Level 3 mg/kg 4.5 mg/kg 5 mg/kg 5.5 mg/kg 6.5 mg/kg
Duration of Treatment (weeks) Continue Treatment
30 4010 200
SDPRPD
Response
Subject
105-001 HER2+ BC
101-001 NSCLC
105-003 TNBC
104-001 HR+HER2-BC
201-004 NSCLC
106-002 NSCLC
202-202 NSCLC
103-001 Other
201-006 NSCLC
106-001 NSCLC
202-001 NSCLC
201-003 NSCLC
102-001 NSCLC
104-007 TNBC
106-007 NSCLC
101-003 NSCLC
109-002 NSCLC
104-010 Other
204-001 NSCLC
104-004 NSCLC
104-009 TNBC
103-005 Other
106-004 NSCLC
204-002 NSCLC
201-007 NSCLC
106-009 NSCLC
205-001 NSCLC
106-006 NSCLC
106-008 NSCLC
104-005 NSCLC
201-005 NSCLC
205-002 TNBC
103-003 Other
103-002 Other
101-002 HR+ HER2-BC
201-008 NSCLC
103-007 Other
103-008 Other
106-010 NSCLC
103-003 Other
104-006 Other
102-004 NSCLC
106-003 NSCLC
105-005 TNBC
Target Lesion Tumor Response Over Time for Patients with Post-baseline Scans
3020100
Duration of Treatment (weeks)
-100
-50
0
50
100
Best Change from Baseline (%)
Other
Dose Level 1.5 mg/kg 3 mg/kg 4.5 mg/kg 5 mg/kg 5.5 mg/kg 6.5 mg/kg
Response
PD
PR
SD
40
NSCLC
HER2+ BC
NSCLC
NSCLC
NSCLC
NSCLCOther
HR+HER2-BCNSCLC
Other
Other
TNBC
TNBC
NSCLC
OtherNSCLC
NSCLC
NSCLC
OtherNSCLC
TNBC
Other
Other
NSCLC Other
HR+HER2-BCNSCLCNSCLC
NSCLC
TNBC
NSCLCNSCLC
NSCLC
NSCLC
NSCLCNSCLCNSCLC
NSCLC
NSCLC
NSCLC
TNBC
NSCLC
NSCLC
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In particular, preliminary efficacy was observed among the patients with NSCLC, with
tumor target lesion shrinkage observed in most patients. The chart below sets forth best tumor
response for NSCLC patients as of May 17, 2024.
Best Tumor Response for NSCLC Patients with Post-baseline Scans
Dose Level 1.5 mg/kg 3m g / k g 4.5 mg/kg 5.5 mg/kg 6.5 mg/kg5m g / k g
100
50
0
-50
-100 Best Change from Baseline (%)
Subject
204-001 204-002 101-001 201-004 202-002 106-007 104-004 106-006 201-008 106-008 201-003 106-009 202-001 101-003 102-001 201-007 106-001 106-010 104-005 106-003 201-006 106-002 106-004 201-005 109-002 205-001 102-004
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Tumor shrinkage was also durable in NSCLC patients. The two charts below set forth the
tumor response over time for NSCLC patients with post-baseline scans and target lesion tumor
response over time for NSCLC patients with post-baseline scans.
Tumor Response Over Time for NSCLC Patients with Post-baseline Scans
Duration of Treatment (weeks)
1.5 mg/kg 3m g / k g 4.5 mg/kg 5m g / k g 5.5 mg/kg 6.5 mg/kg
Response
PD
PR
SD
Continue Treatment
Subject
30 4010 200
Dose Level
102-004 NSCLC
106-003 NSCLC
201-008 NSCLC
106-010 NSCLC
104-005 NSCLC
201-005 NSCLC
106-006 NSCLC
106-008 NSCLC
106-009 NSCLC
205-001 NSCLC
204-002 NSCLC
201-007 NSCLC
106-004 NSCLC
204-001 NSCLC
104-004 NSCLC
101-003 NSCLC
109-002 NSCLC
106-007 NSCLC
201-003 NSCLC
102-001 NSCLC
106-001 NSCLC
202-001 NSCLC
201-006 NSCLC
106-002 NSCLC
202-002 NSCLC
101-001 NSCLC
201-004 NSCLC
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Target Lesion Tumor Response Over Time for NSCLC Patients with Post-baseline
Scans
1.5 mg/kgDose Level 3m g / k g 4.5 mg/kg 5m g / k g 5.5 mg/kg 6.5 mg/kg
Response
PD
PR
SD
Best Change from Baseline (%)
Duration of Treatment (weeks)
100
50
0
-50
-100
0 10 20 30 40
Safety Data . As of May 17, 2024, DB-1310 had an acceptable and manageable safety
profile. The incidence of TEAEs was 91.2% and incidence of grade 3 or above TEAEs was
29.8%. The incidence of TRAEs was 80.7% and incidence of grade 3 or above TRAEs was
19.3%. The most common TRAEs observed were neutrophil count decreased (29.8%), nausea
(28.1%), anemia (26.3%), platelet count decreased (24.6%), and white blood cell count
decreased (21.1%).
Selected Preclinical Data
In preclinical studies, DB-1310’s mAb binds to HER3 with a novel epitope different from
patritumab (the antibody used in U3-1402).
mAb
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The internalization of DB-1310 and an in-house produced U3-1402 analog was measured
on cancer cells expressing HER3. The results showed that DB-1310 is more effectively
internalized by HER3-expressing cancer cells than the reference ADC.
2 4 6 24 48
0
1
2
3
4
Time (h)
Spots per cell
HER3-DXd
DB-1310
IgG1 control
Spots per cell
DB-13104
3
2
0
U3-1402 analog
IgG1 control
Time (h)
2 4 6 24 48
DB-1310 also displayed robust anti-tumor activity in multiple tumor models, including
for PC, NSCLC and BC, and superior results compared to an in-house produced U3-1402
analog in various models. In addition, DB-1310 in combination with EGFR TKI osimertinib
showed greater anti-tumor effects in an NSCLC preclinical model, as illustrated below.
NCI-H1975 NSCLC CDX Model PR9587 Prostate Cancer PDX Model
07 1 4 2 1
0
1,000
2,000
3,000
4,000
5,000
Tumor Volume (mm3) Vehicle
DB-1310 6 mg/kg
Osimertinib 1 mg/kg
DB-1310 + Osimertinib
Day post treatment
Day post treatment
Tumor volume (mm 3)
0 7 14 21 28 35 42 49
0
100
200
300
400
Vehicle
DB-1310 3mg/kg
DB-1310 10mg/kg
Vehicle
DB-1310 3 mg/kg-
DB-1310 10 mg/kg-
Tumor volume (mm3)
Day post treatment
0
100
200
400
300
0 7 14 21 28 35 42 49
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LU1542 NSCLC PDX Model H CC1569 HER3 High BC CDX Model
Day post treatment
Tumor volume (mm 3)
0 7 14 21 28
0
500
1000
1500
2000
2500
Vehicle
Reference 3mg/kg
Reference 10mg/kg
DB-1310 3mg/kg
DB-1310 10mg/kg
Tumor volume (mm3)
Day post treatment
0
2,500
Vehicle
U3-1402 analog 3 mg/kg
U3-1402 analog 10 mg/kg
DB-1310 3 mg/kg
DB-1310 10 mg/kg
7 21 2814
2,000
1,500
1,000
500
0
Day post treatment
Tumor volume (mm 3)
0 5 10 15 20 25
0
500
1000
1500
Vehicle
Reference 1mg/kg
Reference 3mg/kg
DB-1310 1mg/kg
DB-1310 3mg/kg
Tumor volume (mm3)
Day post treatment
0 5 10 15 20 25
1,500
1,000
500
0
Vehicle
U3-1402 analog 1 mg/kg
U3-1402 analog 3 mg/kg
DB-1310 1 mg/kg
DB-1310 3 mg/kg
Next Steps
We are rapidly advancing the phase 1/2a clinical trial for DB-1310 for patients with
advanced or metastatic solid tumors. As the first-in-human study for DB-1310, this phase 1/2a
clinical trial provides foundational data that informs our regulatory discussions with the
competent authorities and shapes our late-stage clinical development strategy. We plan to
announce interim data from DB-1310’s phase 2a expansion cohorts in the second half of 2025.
DB-1310 MAY NOT ULTIMATELY BE SUCCESSFULLY DEVELOPED AND
COMMERCIALIZED.
DB-1305/BNT325, a TROP2 ADC candidate with potential as a frontline backbone therapy,
our key product
Overview
DB-1305 is an in-house discovered TROP2 ADC candidate with a global development
strategy. TROP2, a validated and highly expressed ADC target across a wide spectrum of
cancers, plays a pivotal role in tumor progression. To date, there is only one TROP2 ADC
approved globally, indicated for advanced TNBC, UC and HR+/HER2- BC, according to Frost
& Sullivan. The global TROP2 ADC market is expected to increase from US$1.1 billion in
2023 to US$7.7 billion by 2028, representing a CAGR of 48.8%.
DB-1305 targets indications currently under-explored by other TROP2 ADC candidates,
such as OC. DB-1305 also has combination potential as a backbone therapy in earlier lines of
treatment, starting from NSCLC, OC, CC and TNBC. We believe this well-rounded strategy
may position DB-1305 as a potential backbone therapy in the TROP2 ADC landscape. In
collaboration with BioNTech, we are advancing DB-1305’s global clinical development,
including an ongoing phase 1/2a global trial in patients with advanced solid tumors, where
encouraging preliminary efficacy signals in NSCLC and multiple other solid tumors have been
observed.
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We entered into a license and collaboration agreement with BioNTech in August 2023,
where we granted to BioNTech an exclusive, royalty-bearing and sublicensable license under
certain patents and know-how owned or otherwise controlled by us to develop, manufacture,
commercialize or otherwise exploit DB-1305 and pharmaceutical products comprising DB-
1305 (together “ DB-1305 Products ”) for all uses worldwide except Mainland China, Hong
Kong and Macau. We retain the full rights to develop, manufacture, commercialize and
otherwise exploit DB-1305 and DB-1305 Products in Mainland China, Hong Kong and Macau.
See “— Our Collaboration and Licensing Arrangements — License and Collaboration
Agreement with BioNTech for DB-1305/BNT325” for details.
Drug Design and Mechanism of Action
TROP2 is a transmembrane glycoprotein encoded by the Tacstd2 gene. It is an
intracellular calcium signal transducer that is differentially expressed in many cancers. It
signals cells for self-renewal, proliferation, invasion, and survival. It has stem cell-like
qualities. TROP2 overexpression has been reported in many epithelial cancers, particularly in
prevalent or hard-to-treat cancers including BC, NSCLC, GC and OC, and is associated with
tumor aggressiveness, progression, and metastasis. Importantly, TROP2 overexpression in
tumor cells relative to normal tissue has been well documented, making it a promising cancer
drug target.
DB-1305 is a TROP2-targeted ADC designed with a humanized anti-TROP2 IgG1 mAb,
a cleavable linker, and a proprietary DNA topoisomerase I inhibitor (P1021) conjugated at a
DAR value of 4. The core components of DB-1305 are illustrated below.
DB-1305
P1021
(TOP1 inhibitor)DAR = 4
P102
1
(
T
O
P1
 i
nh
i
b
i
t
o
r
)
D
A
R
 =
 4
Humanized anti-TROP2
IgG1 mAb
After administration, DB-1305’s anti-TROP2 IgG1 mAb directs the ADC selectively to
TROP2-expressing tumor cells. Upon binding and internalization, P1021 is released, and
inhibits DNA topoisomerase-1 activity, thereby suppressing the proliferation of TROP2-
expressing tumor cells. DB-1305’s optimized drug-to-antibody ratio of ~4 helps strike a
balance between potency and tolerability. The linker used is highly stable in circulation. The
payload itself is highly potent but has a short systemic half-life. Additionally, DB-1305
demonstrates a bystander antitumor effect.
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Market Opportunity and Competition
As of the Latest Practicable date, Trodelvy ®, SKB264 (brand name: Գइഺ®) and
Datroway
®
were the only three TROP2 ADCs approved globally or in China. As of the same
date, there were eight TROP2 ADCs indicated for OC under clinical development globally and
eight TROP2 ADCs in combination with immunotherapies in phase 1/2 clinical development
or beyond globally. The global TROP2 ADC market reached US$1.1 billion in 2023. Driven by
TROP2 ADCs’ proven success in indication expansion and the continued exploration of new
clinical applications, the global TROP2 ADC market is expected to further increase to US$7.7
billion in 2028, with a CAGR of 48.8% from 2023. In China, the market size for TROP2 ADCs
is projected to reach US$3.4 billion in 2032, representing a CAGR of 63.8% from 2028. For
more details on the addressable market and competitive landscape of TROP2 ADCs, see
“Industry Overview — Global TROP2 ADC Market — Market Opportunities of TROP2
ADCs.”
We face fierce competition in the TROP2 ADC market from existing and future ADCs
directed against the same molecular targets and indicated for the same indications. Such
competition may become more intense by future collaborations, mergers and acquisitions in the
biopharmaceutical industry. For details of the key features of DB-1305 in comparison with
other TROP2 ADCs, see also “Industry Overview — Global TROP2 ADC Market —
Competitive Landscape.”
To compete effectively in the TROP2 ADC markets, we are developing DB-1305 by
strategically targeting indications previously under-explored by other TROP2 ADC candidates,
such as OC. We are also exploring the combination potential as backbone therapy in multiple
solid tumors, aiming to harness the potent anti-tumor activity of ADCs along with the sustained
benefit of immunomodulators. We and BioNTech are actively exploring DB-1305’s
combination potential as a backbone therapy in early lines of treatment, starting from NSCLC,
OC, CC and TNBC.
OC. OC is the third most common cancer of the female reproductive system worldwide.
High expression of TROP2 is reported in about 83% of OC patients. The global incidence of
OC increased from 295.4 thousand cases in 2018 to 333.9 thousand cases in 2023, and is
projected to further increase to 396.8 thousand cases by 2032. In China, incidence of OC
increased from 57.8 thousand cases in 2018 to 61.6 thousand cases in 2023, and is projected
to increase to 66.6 thousand cases by 2032.
Chemotherapy represents the mainstay of standard treatments for advanced OC in China
and the U.S., which involves platinum-based and taxane-based chemotherapy with or without
antiangiogenic mAb bevacizumab. However, the disease often recurs in a more resistant form
even after initial successful treatment with surgery and chemotherapy. Patients with persistent
disease or progression during first-line treatment are treated with second-line approaches,
primarily consisting of bevacizumab and PARP inhibitors, such as olaparib and niraparib, and
platinum-based or non-platinum-based chemotherapy, depending on whether they are
platinum-sensitive or platinum-resistant. Immunotherapy, such as programmed cell death
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protein 1 (“ PD-1 ”) inhibitors may be considered for patients with certain immunotherapy
biomarkers who have no satisfactory alternative treatment options. However,
immunotherapies, while promising, has shown limited effectiveness in OC when used as a
monotherapy. This limited efficacy and high recurrence rate underscores the need for more
effective and durable treatment options that can improve long-term survival outcomes for
patients. For details of the treatment paradigm of OC in China and the U.S., see “Industry
Overview — Global TROP2 ADC Market — Market Opportunities of TROP2 ADCs —
Ovarian Cancer.”
Traditionally, ADC development has focused on FR /H9251-positive OC patients, who
constitute a limited subset of the OC population. Given that TROP2 is overexpressed in the
majority of OC patients and the under-exploration of OC as an indication for other TROP2
ADC candidates, TROP2 ADCs targeting OC patients represent a promising therapeutic
strategy with vast potential. In addition, TROP2 ADCs can potentially bypass platinum
resistance, providing a novel therapeutic option when standard platinum-based chemotherapy
is no longer effective. They can also be used in combination with or as a complement to
standard platinum-based chemotherapy, potentially enhancing treatment efficacy.
As of the Latest Practicable Date, no TROP2-targeted drugs, including ADCs, had been
approved for OC globally. As of the same date, there were eight TROP2 ADCs targeting OC
under clinical development globally. For details, see “Industry Overview — Global TROP2
ADC Markets — Competitive Landscape.”
NSCLC. TROP2 is broadly overexpressed in NSCLC, making TROP2 ADCs a promising
modality for treating advanced NSCLC regardless of driver mutation status.
The treatment paradigm of advanced NSCLC in China and the U.S. can be broadly
classified based on the presence or absence of driver mutations. For driver mutation-positive
advanced NSCLC, the first-line treatment options include TKIs directed against specific
actionable driver mutations. However, most of these patients eventually acquire resistance to
this treatment. For patients who have failed TKIs, platinum-based doublet chemotherapy with
or without bevacizumab, single-agent chemotherapy, or PD-(L)1 inhibitor is usually
considered. In China and the U.S., for driver mutation-negative advanced NSCLC, the first-line
or later treatment options include chemoimmunotherapy with or without anti-angiogenic mAb
bevacizumab, immunotherapies such as PD-1 and CTLA-4 inhibitors with or without
chemotherapy. For details of the treatment paradigm of NSCLC in China and the U.S., see
“Industry Overview — Global TROP2 ADC Market — Market Opportunities of TROP2 ADCs
— Non-small Cell Lung Cancer.”
As of the Latest Practicable Date, no TROP2-targeted drugs, including ADCs, had been
approved for NSCLC globally. As of the same date, there were 12 TROP2 ADCs targeting
NSCLC under clinical development globally.
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Key Advantages
Highlights of DB-1305 include:
 Well-positioned to address underserved needs in OC treatment. We are actively
investigating DB-1305 for the treatment of advanced OC. Despite the encouraging
therapeutic benefits shown by TROP2 ADCs, the global clinical development of
TROP2 ADCs is currently heavily focused on TNBC, HR+/HER2- BC, UC and
NSCLC. Because TROP2 is a significant prognostic biomarker and therapeutic
target across other prevalent or hard-to-treat cancers, this leaves unmet needs among
patients. OC, for example, is one of the leading causes of cancer death in women
globally with over 300,000 diagnosed each year. Frequently diagnosed at an
advanced stage, OC is associated with a higher mortality rate and poor prognosis,
and many OC patients develop resistance to platinum-based chemotherapies and
other standard treatments. The global OC drug market is expected to increase from
US$4.8 billion in 2023 to US$8.1 billion by 2028, representing a CAGR of 11.1%.
Traditionally, ADC development has focused on FR /H9251-positive OC patients, who
constitute a limited subset of the OC population. Compared to FR /H9251-directed ADCs,
DB-1305 demonstrates broader treatment potential among a wide range of OC
patients, due to TROP2’s high overexpression rate (~83%) in this cancer type. In its
ongoing phase 1/2a global trial, DB-1305 has shown preliminary efficacy in an
all-comer cohort of advanced PROC patients. In January 2024, DB-1305 was
granted Fast Track Designation by the FDA for patients with platinum-resistant
epithelial ovarian, fallopian tube, or primary peritoneal cancer, acknowledging its
potential to address unmet medical needs.
 Combination potential as backbone therapy in multiple solid tumors. We and
BioNTech are actively exploring DB-1305’s combination potential as a backbone
therapy in earlier lines of treatment, starting from NSCLC, OC, CC and TNBC. In
June 2024, the first patient was dosed in a combination cohort of DB-1305’s ongoing
phase 1/2a global trial to evaluate the combination of DB-1305 and BNT327, a bsAb
targeting PD-L1 and VEGF, aiming to harness the potent anti-tumor activity of
ADCs along with the sustained benefit of immunomodulators. In October 2024, we
received IND approval from the NMPA to initiate a phase 1/2a trial for DB-1305 in
combination with BNT327 in patients with late-stage/metastatic solid tumors.
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 Encouraging efficacy and manageable safety profile from phase 1/2a trial. Based on
preliminary data from DB-1305’s ongoing phase 1/2a global trial, which were
published at the 2023 ESMO, DB-1305’s uORR was 30.4% and unconfirmed DCR
was 87.0% among heavily pre-treated patients with advanced solid tumors as of
April 7, 2023. Among the 23 patients with post-baseline tumor scans, encouraging
preliminary efficacy signals were observed in NSCLC patients: uORR was 46.2%
and unconfirmed DCR was 92.3%. Encouraging preliminary efficacy signals of
DB-1305 have also been observed in multiple other solid tumors. Based on
preliminary data from its phase 1/2a global trial, DB-1305 was well-tolerated and all
TEAEs were generally manageable at lower dose levels, with grade 3 or above
TRAEs reported at 34.1% (15/44) in all patients and low incidences of blood-related
TRAEs.
Summary of Clinical Trial Data
We received IND approvals from the FDA and NMPA in May 2022 and August 2022,
respectively, and commenced DB-1305’s first-in-human global MRCT phase 1/2a clinical trial
for advanced/metastatic solid tumors. We were the sponsor of this trial as of the Latest
Practicable Date. Set forth below is a summary of the key information on DB-1305’s ongoing
clinical trial.
Phase 1/2a Clinical Trial for Advanced/Metastatic Solid Tumors ( NCT05438329 )
This is an open-label, multicenter, multiple-dose, phase 1/2a study, including phase 1
dose escalation and phase 2a dose expansion for DB-1305 in patients with advanced solid
tumors. As part of this clinical trial, DB-1305 is being studied in combination with BNT327
across multiple cohorts.
Trial Design. This study consists of two parts, phase 1 dose escalation study and phase
2a dose expansion study, with approximately 1,123 patients expected to be enrolled. Phase 1
adopts an accelerated titration at first dose (2 mg/kg) followed by the classic “3+3” design (4,
6, 8 and 10 mg/kg) to identify MTD and RP2D of DB-1305. Phase 2a is a dose expansion phase
to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors
treated with DB-1305 as monotherapy or combination therapy. Subjects with solid tumors will
be enrolled to treat with DB-1305 in monotherapy or in combination with pembrolizumab or
BNT327 at the RP2D to assess the preliminary anti-tumor activity, safety, tolerability, PK and
other endpoints of DB-1305 when dosed alone, in combination with pembrolizumab and in
combination with BNT327.
Trial Objectives. The primary objective of the phase 1 dose escalation study is to evaluate
safety and tolerability and determine the MTD/RP2D. The primary endpoints of the phase 1
study are safety and tolerability measured by TEAEs, SAEs, laboratory abnormalities reported
up through the safety follow-up period, and AEs meeting DLT criteria, and to determine the
MTD and/or the RP2D of DB-1305 monotherapy. Secondary endpoints include efficacy
(measured by ORR, DoR, DCR, TTR, PFS, OS per RECIST v1.1), PK, and immunogenicity.
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The primary objective of the phase 2a dose expansion study is to assess safety and
tolerability of DB-1305 at the MTD/RP2D and evaluate the efficacy of DB-1305 at the
MTD/RP2D. The primary endpoints of the phase 2a study include SAEs, TEAEs and ORR.
Secondary endpoints include efficacy (measured by DoR, DCR, TTR, PFS, OS per RECIST
v1.1), PK, and immunogenicity.
Trial Progress. This trial was initiated in July 2022 and is currently recruiting patients.
We published the preliminary clinical data at the 2023 ESMO. As of April 7, 2023, the data
cutoff date for 2023 ESMO, 44 patients received DB-1305 at four dose levels (2 mg/kg, n=1;
4 mg/kg, n=20; 5 mg/kg, n=17; 6 mg/kg, n=6; all were enrolled in the phase 1) and received
a median of 3 (range, 1-6) prior lines of therapy. The median treatment duration was 1.5 (range,
0.7-6.1) months, and a total of 25 patients (56.8%) remained on treatment. The table below sets
forth details of the baseline characteristics of these 44 patients.
Total (n=44)
Age, Median (range) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111859.0 (40.0-78.0)
Female , n (%) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (59.1)
Region , n (%)
United States /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (47.7)
China /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (52.3)
ECOG Performance Status , n (%)
0 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (15.9)
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/H1118/H1118/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 (84.1)
Median Prior Lines of Therapy , Median (range) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183.0 (1-6)
Cancer Types , n (%)
Non-small Cell Lung Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111830 (68.2)
Colorectal Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (9.1)
HR+HER2-breast cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (4.5)
Ovarian Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (4.5)
Ampullary Carcinoma /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (2.3)
Appendiceal Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (2.3)
Duodenal Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (2.3)
Gastric or Gastroesophageal Junction Adenocarcinoma /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 (2.3)
Primary Malignant Neoplasm of Fallopian Tube /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 (2.3)
Triple-negative Breast Cancer /H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 (2.3)
Prior Anticancer Systematic Therapy , n (%)
With Prior Immunotherapy Therapy /H1118/H1118/H1118/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 (45.5)
With Prior Platinum Therapy /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111839 (88.6)
In March 2025, we published the latest clinical data from this trial at the 2025 Society of
Gynecologic Oncology Annual Meeting on Women’s Caner (“ 2025 SGO ”).
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Efficacy Data. As of April 7, 2023, a total of 23 patients had undergone at least one
post-baseline tumor scan. The overall uORR was 30.4% (7/23) and unconfirmed DCR was
87.0% (20/23) in patients with TROP2-expressing advanced solid tumors (n = 23) who had
received a median of 3 prior lines of therapy (range, 1-6). In the NSCLC cohort, the uORR was
46.2% (6/13) and the unconfirmed DCR was 92.3% (12/13). Antitumor activity was also
observed in a patient with fallopian tube cancer, with one unconfirmed PR at the 5 mg/kg dose
level, resulting in an ORR of 1/1 in that patient. The table below sets forth details of the best
tumor response for all patients with post-baseline scans.
Best Change from Baseline (%)
As of December 15, 2024, the data cutoff date for 2025 SGO, DB-1305 demonstrated
encouraging durable efficacy in patients with previously treated ovarian cancer, with ORR of
41.4%, DCR of 82.8%, mDOR of 7.3 months, and mPFS of 7.4 months (N=58).
Safety Data. As of April 7, 2023, DLT occurred in three patients who received the 6 mg/kg
dose. As such, 5 mg/kg was established as the MTD. No TEAE led to death. TRAEs primarily
included stomatitis, nausea, infusion-related reaction, decreased appetite, mucosal
inflammation and interstitial lung disease. Grade 3 or above TRAEs were reported in 34.1%
(15/44) of patients, with the most common being stomatitis (22.7%), nausea (2.3%), and
mucosal inflammation (2.3%). DB-1305 was tolerable and all TEAEs were generally
manageable at lower dose levels (i.e., 2 and 4 mg/kg). The table below sets forth details of the
safety data as of April 7, 2023.
2 mg/kg
(n=1)
n (%)
4 mg/kg
(n=20)
n (%)
5 mg/kg
(n=17)
n (%)
6 mg/kg
(n=6)
n (%)
Total
(n=44)
n (%)
Any TEAEs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 (100.0) 19 (95.0) 15 (88.2) 6 (100.0) 41 (93.2)
Grade /H113503 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181 (100.0) 13 (65.0) 6 (35.3) 5 (83.3) 25 (56.8)
Serious TEAEs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180 6 (30.0) 5 (29.4) 4 (66.7) 15 (34.1)
Led to does reduction /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180 1 (5.0) 2 (11.8) 3 (50.0) 6 (13.6)
Led to does interruption /H1118/H1118/H1118/H1118/H1118/H11180 9 (45.0) 6 (35.3) 4 (66.7) 19 (43.2)
Led to dose discontinuation /H1118/H1118/H1118/H11180 2 (10.0) * 0 0 2 (4.5)
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2 mg/kg
(n=1)
n (%)
4 mg/kg
(n=20)
n (%)
5 mg/kg
(n=17)
n (%)
6 mg/kg
(n=6)
n (%)
Total
(n=44)
n (%)
Any TRAEs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180 19 (95.0) 15 (88.2) 6 (100) 40 (90.9)
Grade /H113503 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180 7 (35.0) 5 (29.4) 3 (50.0) 15 (34.1)
Serious TRAEs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180 3 (15.0) 4 (23.5) 3 (50.0) 10 (22.7)
Led to dose reduction /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180 1 (5.0) 2 (11.8) 3 (50.0) 6 (13.6)
Led to dose interruption /H1118/H1118/H1118/H1118/H1118/H11180 6 (30.0) 5 (29.4) 4 (66.7) 15 (34.1)
Led to dose discontinuation /H1118/H1118/H1118/H11180 1 (5.0) 0 0 1 (2.3)
Dose-limiting toxicities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180003 (50.0) 3 (6.8)
* One patient died by suicide on day 18 after first dose and one patient experienced double pneumonia
on day 49.
As of December 15, 2024, the data cutoff date for 2025 SGO, DB-1305 demonstrated a
manageable safety profile and was generally well tolerated.
PK Data. Exposure parameters (maximum plasma concentration (“ Cmax”) and area under
the curve (“ AUC”)) of DB-1305 ADC increased with dose in the dose range of 2 to 6 mg/kg.
The half-life of DB-1305 ADC is approximately 3.0-4.5 days for a dose range of 4 to 6 mg/kg.
The exposure of release payload was magnitudes lower than that of DB-1305 ADC, with
ADC/payload molar ratio of approximately 80, demonstrating stability of the ADC in systemic
circulation.
Selected Preclinical Data
In preclinical studies, DB-1305 induced dose-dependent tumor growth inhibition and
tumor regression. Potent anti-tumor effect was observed in TROP2 high and low tumor models
with a wide therapeutic window.
TROP2-high CDX MDA-MB-468
(breast cancer)
MDA-MB-468 tumor xenograft model
Tumor volume mean ± SEM
TROP2-low CDX Colon-205
(colon cancer)
Colon-205 tumor xenograft model
Tumor volume mean ± SEM
Vehicle, once, i.v.
DB-1305, 1mpk, once, i.v.
DB-1305, 3mpk, once, i.v.
DS-1062*, 1mpk, once, i.v.
DS-1062*, 3mpk, once, i.v.
400
300
200
100
0
0 7 14 21
Days after that start of treatment
Tumor volume (mm3)
TGI = 77.31%
TGI = 92.09%
28
TGI = 17.54%
TGI = 22.11%
TGI = 20.22%
TGI = 37.77%
Vehicle, once, i.v.
DB-1305, 3mpk, once, i.v.
DB-1305, 10mpk, once, i.v.
DS-1062*, 3mpk, once, i.v.
DS-1062*, 10mpk, once, i.v.
Days after that start of treatment
Tumor volume (mm3)
1000
800
600
400
200
0
0 7 14 21 28
TGI = 41.45%
TGI = 79.89%
* An in-house produced analog of DS-1062.
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Next Steps
We are rapidly advancing the phase 1/2a clinical trial for DB-1305 for patients with
advanced or metastatic solid tumors. As the first-in-human study for DB-1305, this Phase 1/2a
clinical trial provides foundational data that informs our regulatory discussions with the
competent authorities and shapes our late-stage clinical development strategy. Subject to
clinical progress and communications with the competent authorities, we and BioNTech plan
to initiate a global potential registrational study for DB-1305 in 2025.
DB-1305/BNT325 MAY NOT ULTIMATELY BE SUCCESSFULLY DEVELOPED AND
COMMERCIALIZED.
Other ADC assets derived from our DITAC platform include (i) DB-1312, a novel B7H4
ADC we out-licensed to BeiGene in 2023 in a transaction exceeding US$1.3 billion in deal
value. DB-1312 is currently at clinical stage. See also “— Our Collaboration and Licensing
Arrangements — Out-license and Collaboration Agreement with BeiGene on DB-1312”; and
(ii) DB-1314 and DB-1317, two preclinical ADC candidates. Going forward, we will continue
to leverage our DITAC platform to optimize the design and engineering of ADC drugs for
cancer treatment.
ADC Assets Developed from DIMAC Technology Platform
DIMAC — Next-generation Immune-modulating ADC Platform
We believe immune-modulating ADCs holds the potential to open the ADC modality to
a significant white-space market in autoimmune and other therapeutic areas. Many patients
with chronic autoimmune diseases, such as SLE and CLE, are currently treated with therapies
that often lead to severe side effects. Long term use of glucocorticoids, for example, are
commonly associated with increased risks of bone fractures, weight gain, diabetes, immune
system suppression, and other chronic conditions. We believe ADCs can reshape the treatment
paradigm of autoimmune diseases by offering a targeted treatment with low systemic exposure,
enhanced efficacy and reduced side effects. Immune-modulating ADCs have been validated by
preliminary clinical data from peers, showing better safety and efficacy profiles compared to
the antibody alone.
We are a global pioneer in this space with the ability to mobilize our accumulated
technology in oncology into innovation of autoimmune ADCs, according to Frost & Sullivan.
Leveraging our technology accumulation in target and payload selection and ADC design, our
DIMAC platform has demonstrated broad anti-inflammatory activity, long duration of action,
sustained stability, and low systemic exposure in preclinical studies. We have developed a deep
technological moat for DIMAC with patent protection extending beyond 2040.
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DB-2304, Innovative Autoimmune ADC for SLE/CLE, our Key Product
Overview
DB-2304 is an in-house discovered, innovative BDCA2 ADC candidate for SLE and CLE,
being one of the most advanced BDCA2 ADCs in terms of development progress, according
to Frost & Sullivan. DB-2304 offers a selective therapeutic approach specifically targeting the
upstream signaling pathways of SLE/CLE pathogenesis, differentiating it from existing lupus
treatments that often have broader effects on the immune system. We believe DB-2304 holds
promise to substantially improve upon the standard of care for SLE and CLE, such as
glucocorticoids and immunosuppressants, and represents a major step in the innovation of
autoimmune ADCs. We initiated a phase 1 study in healthy adults for DB-2304 in Australia in
October 2024. We have obtained IND approvals from the FDA and NMPA for DB-2304 and
expect to complete DB-2304’s phase 1 global trial in 2026.
Drug Design and Mechanism of Action
SLE is a complex autoimmune disorder characterized by the dysregulation of the immune
system, leading to widespread inflammation and tissue damage. A key pathogenic feature of
SLE is the abnormal production of IFN-I, which are signaling molecules that play a central role
in driving autoimmune response, including the maturation and differentiation of autoreactive
B cells, promotion of antibody production, and enhancement of adaptive immune response
generation. The excessive and sustained production of IFN-I is primarily driven by the
over-activation of pDCs.
BDCA2 is a unique and clinically validated receptor expressed on pDCs, according to
Frost & Sullivan. When BDCA2 is engaged by mAb, it triggers an inhibitory signaling cascade
that suppresses activation of pDCs and reduces IFN-I production. This negative feedback
mechanism helps to control pDC activation and prevent excessive IFN-I production.
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DB-2304 is a BDCA2-directed ADC designed with a novel BDCA2-targeting antibody
conjugated to a proprietary GR agonist payload at a DAR of 4. DB-2304’s core components and
mechanism of action are illustrated below.
DB-2304
BDCA2 BDCA2
DAR = 4 GR Agonist
Triggers
Genetic, environmental, hormonal and viral factors
Innate Immune
DB-2304
Adaptive Immune
DC
 T cell
Cytokines
B cell
Type I IFNs
Autoantibody Production
Tissue Damage
pDC
The engagement of BDCA2 by the antibody contributes to the suppression of pDC
activation and IFN-I production. Upon binding to BDCA2, DB-2304 is internalized into the
pDCs, where its novel GR agonist payload is released. The GR agonist acts to drive the
transcription of glucocorticoid response genes suppressing pro-inflammatory cytokine
secretion. These two mechanisms combined result in synergistic modulation of a broad
spectrum of anti-inflammatory responses, beyond IFN regulation in pDCs.
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By eliminating the primary source of interferon overproduction, DB-2304 aims to
interrupt the self-perpetuating cycle of immune dysregulation and inflammation that is central
to the pathogenesis of SLE. Reducing the abnormal levels of type I interferons could have
multiple beneficial effects, including inhibiting the activation of antigen presentation, limiting
the differentiation of autoantibody-producing plasma cells, and dampening the overall
autoimmune response.
Market Opportunity and Competition
SLE. SLE is an autoimmune disease characterized by the production of autoantibodies
that target the body’s own tissues and cells. It is the most common type of lupus, causing
widespread inflammation and tissue damage in the affected organs. The global prevalence of
SLE grew from 7,632.8 thousand cases in 2018 to 8,048.8 thousand cases in 2023. It is
projected to increase to 8,800.3 thousand cases by 2032. In China, the prevalence of SLE grew
from 1,015.6 thousand cases in 2018 to 1,048.3 thousand cases in 2023. It is projected to
increase to 1,078.3 thousand cases by 2032.
With advancements in diagnostic tools and treatment options, the prognosis for
individuals with SLE has improved significantly over the past few decades. However, SLE
remains a chronic and potentially life-threatening condition, and calls for innovative treatment
options with improved efficacy. A major shortcoming of mainstay treatments for SLE, such as
glucocorticoids and immunosuppressants, is their inability to address the high heterogeneity of
pathogenesis in these complex diseases, which often result in limited efficacy and serious side
effects, especially when used long term for chronic disease management. For details of the
treatment paradigm of SLE in China and the U.S., see “Industry Overview — Global BDCA2
ADC Market — Market Opportunities of BDCA2 ADCs — Systemic Lupus Erythematosus.”
Given the complex and heterogeneous nature of SLE, an ideal treatment modality for SLE
should be able to achieve optimal disease control and minimize long-term side effects, calling
for the development of targeted therapies such as ADCs. As a validated target that is
specifically expressed on pDCs, BDCA2’s over-production of IFN-I is crucial in SLE
pathogenesis, making BDCA2-targeted ADCs promising for the treatment of SLE.
CLE. CLE is an autoimmune disorder that primarily affects the skin. CLE is characterized
by a range of inflammatory skin lesions and rashes that can appear on various parts of the body,
including the face, scalp, arms, and trunk. The global annual incidence of CLE remained
relatively stable at approximately 330 thousand cases from 2018 to 2023, and is projected to
reach 363.4 thousand cases in 2032. In China, the incidence of CLE grew from 55.8 thousand
cases in 2018 to 57.2 thousand cases in 2023, and is projected to remain at an annual incidence
of approximately 58 thousand cases from 2023 to 2032.
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In China, first-line systematic therapy for CLE patients is hydroxychloroquine.
Glucocorticoids, thalidomide, retinoids and amifostine are used as second-line treatments.
Third-line treatments include methotrexate, mycophenolate mofetil. In the U.S., first-line
systemic therapy for CLE patients is the use of an oral antimalarial medication. In second-line
settings, oral retinoids such as acitretin and isotretinoin, immunosuppressants such as
methotrexate are recommended. For details of the treatment paradigm of CLE in China and the
U.S., see “Industry Overview — Global BDCA2 ADC Market — Market Opportunities of
BDCA2 ADCs — Cutaneous Lupus Erythematosus.”
Despite the available treatment options, many patients continue to experience suboptimal
disease control, highlighting the need for more effective and targeted therapies such as ADCs
to improve outcomes for individuals living with this debilitating autoimmune skin condition.
As of the Latest Practicable Date, there were no approved BDCA2 ADCs and no BDCA2
ADCs indicated for SLE or CLE under clinical development globally or in China.
Key Advantages
 Novel targeted treatment to address unmet needs for SLE and CLE. SLE and CLE
are autoimmune diseases that together affect over eight million patients globally,
according to Frost & Sullivan. A major shortcoming of mainstay treatments, such as
glucocorticoids and immunosuppressants, is their inability to address the high
heterogeneity of pathogenesis in these complex diseases, which often result in
limited efficacy and serious side effects, especially when used long term for chronic
disease management. DB-2304 offers a selective therapeutic approach specifically
targeting the upstream signaling pathways of SLE/CLE pathogenesis, differentiating
it from existing lupus treatments that often have broader effects on the immune
system.
 Good stability and safety profile. In preclinical studies, DB-2304 showed strong
stability in plasma with little change in concentration or DAR value up to 21 days.
Good stability and low level of systemic exposure of free payload indicates a good
safety profile, as illustrated below. DB-2304 also showed promising safety profile
with a NOAEL of 85 mg/kg.
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 Strong efficacy with synergistic functions. Preclinical studies also show that
DB-2304 demonstrates greater potency with synergistic effects in suppressing
production of both IFN-I and pro-inflammatory cytokines. DB-2304 is designed to
combine the efficacy of mechanisms mediated by BDCA2-targeting mAb
(demonstrated by INF /H9251suppression) and the GR agonist payload (demonstrated by
IL-6 and IP-10 suppression), as illustrated below.
IFNα
IFNa (pg/ml)
20,000
15,000
10,000
5,000
0
BIIB059 (BDCA2 mAb)*
Hu033-03 (DB-2304 mAb)
DB-2304
Dex
IgG1 300nM
Cell only
IL-6
IL-6( pg/ml)
1,500
1,000
500
0
IP-10
IP-10 (pg/ml)
30,000
20,000
10,000
0
0
8E-04
0.004
0.019
0.096
0.048
2.4
12
60
300
0
8E-04
0.004
0.019
0.096
0.048
2.4
12
60
300
0
8E-04
0.004
0.019
0.096
0.048
2.4
12
60
300
0
0.003
0.015
0.077
0.384
1.92
9.6
48
240
1,200
300
Concentration (nM)
* Litifilimab (known as BIIB059), a BDCA-targeting mAb developed by Biogen
Summary of Clinical Trial Data
We submitted clinical trial notification to the Therapeutic Goods Administration (“ TGA”)
of Australia in September 2024 to conduct DB-2304’s phase 1 clinical trial in healthy subjects
in Australia, and received the TGA’s acknowledgment in the same month. Set forth below is
a summary of the key information on DB-2304’s ongoing clinical trial.
Phase 1 Clinical Trial in Healthy Adults in Australia (NCT06625671)
This is a randomized, double-blind, placebo- and positive-controlled, single ascending
dose phase 1 study to evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of DB-2304 injection in healthy adult participants.
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Trial Design. Participants will be enrolled in five cohorts and randomized to receive
escalating doses of DB-2304 or placebo. This trial will be performed in a single ascending dose
design. The decision to escalate to subsequent dose levels will be made based on the review
of all available safety information and PK/PD data in each cohort.
Trial Objectives. The primary objective is to evaluate the safety and tolerability of single
ascending dose of DB-2304 in healthy adult participants. The primary endpoints are safety
parameters such as TEAE and SAE.
Trial Progress. This trial was initiated in October 2024 and is currently ongoing.
Next Steps
We initiated a phase 1 study in healthy adults for DB-2304 in Australia in October 2024.
We have obtained IND approvals from the FDA and NMPA for DB-2304 and expect to
complete DB-2304’s phase 1 global trial in 2026 through separate protocols assessing single
ascending doses in healthy volunteers and multiple ascending doses in SLE/CLE patients.
Subject to clinical progress and communications with the competent authorities, we plan to
achieve proof-of-concept in SLE patients in 2025 and enroll the first patient in DB-2304’s
phase 2 clinical trial in 2026.
DB-2304 MAY NOT ULTIMATELY BE SUCCESSFULLY DEVELOPED AND
COMMERCIALIZED.
ADC Assets Developed from DIBAC Technology Platform
DIBAC — Next-generation BsADC Platform
BsADCs are next-generation ADCs with an innovative targeting backbone, according to
Frost & Sullivan. By incorporating two distinct binding moieties in a single therapeutic entity,
BsADCs can potentially offer meaningful advantages over traditional monospecific ADCs and
combination therapies.
While promising, the complexity of BsADCs introduces new challenges in antibody
engineering, stability and manufacturing. Our innovative DIBAC platform features our
understanding of disease and target biology, rich experience in bispecific antibody engineering,
and artificial intelligence-enabled target selection and antibody design. For details on the
differentiating features of our DIBAC platform, see “— Our Competitive Strengths —
Innovator in ADC development powered by versatile platforms to target underserved
therapeutic areas.”
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DB-1419, Innovative B7-H3xPD-L1 BsADC Candidate
Overview
DB-1419 is an in-house discovered, innovative B7-H3xPD-L1 BsADC candidate with a
DNA topoisomerase I inhibitor, being the only B7-H3xPD-L1 BsADC currently under clinical
development globally, according to Frost & Sullivan. The simultaneous action of delivering the
toxin to tumor cell and modulate T cell activation provides potential synergistic anti-tumor
effect. Combining payload mediated cytotoxicity with antibody mediated immunotherapy
activity, DB-1419 provides an innovative approach for cancer treatment. We have obtained
IND approvals from the FDA and the NMPA for DB-1419 and we initiated DB-1419’s phase
1/2a global trial in September 2024.
Drug Design and Mechanism of Action
DB-1419 is a B7-H3/PD-L1-directed ADC composed of a humanized B7-H3/PD-L1
bispecific antibody, covalently linked to a topoisomerase inhibitor (P1003) via a cleavable
linker, with a DAR value of 8. DB-1419’s core components are illustrated below.
DB-1419
P1003
B7-H3
(TOP1 inhibitor)DAR = 8
PD-L1
DB-1419 selectively binds to human B7-H3 and PD-L1 with no cross reactivity to other
B7 family proteins. DB-1419 can selectively bind to and be endocytosed into the lysosome of
B7-H3-positive cells. DB-1419 induces B7-H3-dependent cytotoxicity, causes G2/M cell cycle
arrest, induces DNA damage, and inhibits cell proliferation in a concentration-dependent
manner towards B7-H3-expressing cells. Simultaneously, by binding to PD-L1, DB-1419
blocks the interaction between PD-L1 and PD-1 receptors, reversing PD-L1-mediated immune
suppression and enhancing T cell activation. This dual mechanism results in effective direct
cytotoxicity against tumor cells and robust immune modulation, significantly inhibiting tumor
growth and demonstrating improved therapeutic outcomes in preclinical models.
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Key Advantages
 First-mover advantage. DB-1419 is an innovative B7-H3xPD-L1 BsADC candidate,
being the only B7-H3xPD-L1 BsADC currently under clinical development
globally, according to Frost & Sullivan. As of the Latest Practicable Date, there were
no approved drugs targeting both B7-H3 and PD-L1 globally and no B7-H3xPD-L1
BsADC candidates under clinical development worldwide. We believe B7-H3’s
pan-cancer expression coupled with PD-L1’s immune-modulating function may
offer enhanced anti-tumor effects across broad indications.
 Synergistic immune modulation. By targeting PD-L1, DB-1419 blocks the
interaction between PD-L1 and PD-1. This blockade reverses PD-L1-mediated
immune suppression, enhancing T cell activation and promoting a robust anti-tumor
immune response. The dual action of direct cytotoxicity and immune modulation can
potentially improve overall therapeutic efficacy.
 Better efficacy than monospecific B7-H3 ADC. DB-1419 demonstrated superior
efficacy over a monospecific B7-H3 ADC in syngeneic model and immune
reconstitute model in preclinical studies. The results indicated that DB-1419 exhibit
tumor growth inhibition effect through the simultaneous action of immune check
point inhibitor activity and payload toxicity activity.
Summary of Clinical Trial Data
We obtained IND approval from the FDA for DB-1419 in September 2024 and initiated
DB-1419’s phase 1/2a trial. We received IND approval for DB-1419 from the NMPA in March
2025. Set forth below is a summary of the key information on DB-1419’s ongoing clinical trial.
Phase 1/2a Clinical Trial in Patients with Advanced/Metastatic Solid Tumors (NCT06554795)
This is a phase 1/2a, multicenter, open-label, first in human study to assess the safety,
tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1419 in patients with
advanced/metastatic solid tumors.
Trial Design. Participants will be enrolled in six cohorts to receive six dose levels of
DB-1419. In addition to these initial dosing groups, this trial also includes eight dose
expansion phases.
Trial Objectives. The primary objective is to evaluate the safety and tolerability of
DB-1419 and determine the MTD/RP2D. The primary endpoints are safety parameters such as
TEAE and SAE.
Trial Progress. This trial was initiated in September 2024 and is currently ongoing.
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Selected Preclinical Data
DB-1419 showed a more pronounced and sustained tumor volume reduction effect than
a monospecific B7-H3 ADC during the study period, as illustrated below, in a syngeneic mouse
tumor model.
Tumor Volume (mm3)
Days Post Treatment (d)
3,000
2,000
1,000
0
0 7 14 21
bsAb ADC
**
mono ADC
Isotype-ADC, 10 mg/kg
B7-H3 ADC, 5.5 mg/kg
DB-1419, 12 mg/kg
In an efficacy comparison study, DB-1419 demonstrated comparable tumor reduction
effect compared to a B7-H3 ADC and PD-1 mAb combination therapy (monospecific B7-H3
ADC + pembrolizumab) during the study period.
Tumor Volume (mm3)
Days post Administration
Isotype ADC, 15 mg/kg2,000
1,500
1,000
500
0 3 6 9 12 15 18 21
DB-1419, 18 mg/kg
B7-H3 ADC, 18 mg/kg +
Pembrolizumab, 15 mg/kg
Next Steps
We have obtained IND approvals from the FDA and the NMPA for DB-1419 and we
initiated DB-1419’s phase 1/2a global trial in September 2024. We plan to explore the potential
of DB-1419 across various solid tumors, including SCLC, HCC, NSCLC, melanoma, ESCC,
and TNBC. We plan to publish the study design for DB-1419’s phase 1/2a global trial at the
2025 AACR Annual Meeting, with data readout anticipated in 2026, and to complete this trial
by 2027. As the first-in-human study for DB-1419, this phase 1/2a clinical trial provides
foundational data that informs our regulatory discussions with the competent authorities and
shapes our late-stage clinical development strategy.
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DB-1419 MAY NOT ULTIMATELY BE SUCCESSFULLY DEVELOPED AND
COMMERCIALIZED.
DB-1418/AVZO-1418, Differentiated EGFRxHER3 BsADC
Overview
DB-1418 is an in-house discovered EGFRxHER3 BsADC. Due to target synergies,
EGFRxHER3 BsADCs have demonstrated enhanced efficacy and ability to overcome
resistance to EGFR- or HER3-directed treatments in clinical studies. Our DB-1418 is
differentiated by a “1+1” format molecule design (two binding sites, one for each target) that
translates to higher binding affinity to tumor cells as opposed to healthy cells. DB-1418 has
also shown better efficacy in EGFR-resistant, EGFR-low or HER3-resistant models, potentially
offering broader patient coverage. We are conducting IND-enabling studies for DB-1418 and
expect to advance this molecule into clinical stage in the first half of 2025.
We entered into a collaboration and license agreement with Avenzo in December 2024,
pursuant to which we granted Avenzo an exclusive license to develop, manufacture and
commercialize DB-1418 globally excluding Greater China. We have also granted to Avenzo a
non-exclusive license to develop and manufacture DB-1418 in Greater China solely for the
development of DB-1418, for purposes of obtaining regulatory approval of DB-1418 and for
the other exploitation of DB-1418 outside Greater China. We retain all other rights to develop,
manufacture, commercialize and otherwise exploit DB-1418 in Greater China. For details, see
“— Our Collaboration and Licensing Arrangements — Collaboration with GSK and Avenzo.”
Drug Design and Mechanism of Action
DB-1418 is EGFR and HER3 dual targeting ADC comprised of a fully human
EGFRxHER3 bispecific antibody conjugated to a topoisomerase I inhibitor payload P1021 via
a cleavable linker. DB-1418’s core components are illustrated below.
DB-1418
P1021
EGFRHER3
(TOP1 inhibitor)DAR = 6
P1021
EGFR
HER3
(TOP1 inhibitor)
DAR = 6
HER3
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DB-1418 is designed with a unique “1+1” format molecule design, in contrast to the
“2+2” format (four binding sites, two for each target) used in other BsADCs. Compared to
BsADCs with a “2+2” format, DB-1418’s “1+1” format has the potential to bring more
payloads to tumor in addition to enhanced selectivity between tumor versus normal tissues.
Key Advantages
 Differentiated “1+1” format molecule design. Leveraging the “1+1” format
molecule design, DB-1418 exhibited higher binding affinity to tumor cells (which
express both EGFR and HER3) compared to other BsADCs with a “2+2” design.
Due to the “1+1” design, DB-1418 also demonstrates better internalization than
other “2+2” format EGFRxHER3 BsADCs, as illustrated below.
NCI-H1975 (L858R/T790M)
EGFR ++, HER3 +
MFI
Antibody conc. (nM)
40,000
30,000
20,000
10,000
0
0.001 0.01 0.1 1 10 100 1,000
DB-1418 antibody
EGFR x HER3 (2+2) antibody
Isotype IgG1
Internalization Assay on NCI-H1975 – 48 h
(Sample: 1 nM)
Total Red Object Integrated Intensity
(RCU x μm2/Image
150,000
100,000
50,000
0
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 Synergistic efficacy. Simultaneously binding to EGFR and HER3 by DB-1418
potentially translates to synergistic anti-tumor effects, significantly enhancing its
therapeutic impact compared to traditional monospecific ADCs. In preclinical
studies, DB-1418 achieved tumor growth inhibition (“ TGI”) of 99.32% in the
NCI-H1975 model (EGFR++, HER3+) at 6 mg/kg, significantly higher than the TGI
of 53.88% for a HER3-targeting ADC.
NCI-H1975 (EGFR++, HER3+) model
3,000
2,000
1,000
0
Tumor Volume (mm3)
0 5 10 15 20 25
Days Post Treatment (d)
TGI=53.88%
TGI=96.19%
TGI=99.32%
Vehicle
HER3 ADC
HER3 ADC + Osimertinib
DB-1418
 Overcoming resistance. A major advantage of DB-1418 is its ability to overcome
resistance to conventional EGFR-targeted therapies. EGFR can bind to multiple
ligands and, once internalized, the ligand-receptor complex can be recycled to cell
surface. The recycling of ADCs may lead to inefficient payload processing in
lysosome and potentially contribute to resistance mechanism of anti-EGFR
monospecific ADCs. BsADCs like DB-1418 can better modulate intracellular
trafficking by targeting two receptors and hence enhance intracellular release of
payload.
Next Steps
We are conducting IND-enabling studies for DB-1418 and expect to advance this
molecule into clinical stage in the first half of 2025. We plan to explore the potential of
DB-1418 across various solid tumors, including ESCC, HNSCC, CRC, non-melanoma skin
cancer, NSCLC, GC, pancreatic adenocarcinoma, nasopharyngeal cancer, bladder cancer, and
BC.
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DB-1418/A VZO-1418 MAY NOT ULTIMATELY BE SUCCESSFULLY DEVELOPED
AND COMMERCIALIZED.
ADC Assets Developed from Novel MOA Payload Technology Platform
DUPAC — Unique Novel MOA payload ADC platform
We are building DUPAC to develop linker-payload complexes with novel mechanisms of
action beyond traditional cytotoxic agents to combat growing drug resistance and hard-to-treat
tumors. Notably, the anti-proliferation activity of our unique payload, P5142, was examined on
various cancer type cells and compared with Dxd, a DNA topoisomerase I inhibitor. Cell
viability was evaluated after five days’ treatment using the CellTiter-Glo
® Luminescent Cell
Viability kit. Significantly superior potency of P5142 was observed in Dxd-insensitive
(low-response) cancer cells BT-474, JIMT-1 and NCI-H660. Overall, the different
susceptibility of cells to Dxd and P5142 is due to the distinct mechanism of action of these two
payloads.
BT-474 (BC) JIMT-1 (BC) NCI-H660 (CRPC)
0.01 0.1 1 10 100 1000
-20
0
20
40
60
80
Concentration of Cpd. [nM] /g3
Inhibition Rate (%)
Dxd
P5142
0.01 0.1 1 10 100 1000
-20
0
20
40
60
80
100
120
Concentration of Cpd. [nM] /g3
Inhibition Rate (%)
Dxd
P5142
0.001 0.01 0.1 1 10 100 1000
-20
0
20
40
60
80
100
120
Concentration of Cpd. [nM] /g3
Inhibition Rate (%)
Dxd
P5142
We have made promising progress in a number of unique payload mechanisms and have
obtained prototypes with broad-spectrum anti-tumor activity across multiple solid tumors, and
potent direct and bystander killing effects in preclinical studies. In particular, our in-house
discovered lead prototype has a unique mechanism of action with demonstrated broad-
spectrum anti-tumor activity across multiple solid tumors and remains potent in tumors
resistant to deruxtecan. ADCs designed with our lead prototype have also shown potent direct
and bystander killing effects and induce strong immunogenic cell death. DB-1316, for
example, is a novel ADC asset derived from the DUPAC platform currently in preclinical stage
positioned to target deruxtecan-resistant solid tumors. We aim to receive the first IND approval
for an ADC candidate derived from our DUPAC platform as early as 2026.
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OUR COLLABORATION AND LICENSING ARRANGEMENTS
We have entered into several out-licensing and collaboration deals with leading industry
players worldwide to date, including BioNTech, BeiGene, Adcendo, GSK, and Avenzo, with
over US$6.0 billion in total deal value (of which approximately US$500 million had been
received as of the Latest Practicable Date). Each of BioNTech, BeiGene, Adcendo, GSK, and
Avenzo is an Independent Third Party. Additionally, we have strategically in-licensed advanced
antibody technologies to enhance our drug development efficiency, while complementing our
in-house capabilities in antibody research and drug discovery.
We believe our collaboration strategy promotes the growth of a strong, interconnected
ecosystem that benefits both ourselves and our upstream and downstream partners. Through
collaboration with diverse stakeholders across the industry chain, we create synergies that not
only drive innovation but also broaden market opportunities for all participants, laying a
foundation for our long-term, sustainable growth.
License and Collaboration Agreement with BioNTech for DB-1303/BNT323
On March 16, 2023, we entered into a license and collaboration agreement with BioNTech
SE (Nasdaq: BNTX, “ BioNTech ”) (as may be amended from time to time, the “ DB-1303
License and Collaboration Agreement ”), where we granted to BioNTech an exclusive,
royalty-bearing and sublicensable license under certain patents and know-how owned or
otherwise controlled by us to develop, manufacture, commercialize or otherwise exploit
DB-1303 and pharmaceutical products comprising DB-1303 (together “ DB-1303 Products ”)
for all uses worldwide except Mainland China, Hong Kong and Macau (the “ Territory ”). We
retain the full rights to develop, manufacture, commercialize and otherwise exploit DB-1303
and DB-1303 Products in Mainland China, Hong Kong and Macau (collectively, the “ Retained
Territory ”).
We and BioNTech have established a joint steering committee (“ JSC”) comprised of an
equal number of representatives from each party to oversee the development of DB-1303
Products in the Territory and facilitate information exchange under this agreement. As of the
Latest Practicable Date, the JSC comprised six members, equally represented by three members
each from our Company and BioNTech. The JSC will endeavor to make decisions by
consensus, with the representatives of each party having, collectively, one vote. If the
representatives on the JSC cannot reach an agreement, such disagreement shall be referred to
the chief executive officers of both parties for resolution. If the chief executive officers cannot
resolve such matter, we shall generally have the final decision-making authority with respect
to the development of DB-1303 and DB-1303 Products in the Retained Territory, while
BioNTech shall generally have the final decision-making authority with respect to the
development of DB-1303 Products in the Territory. Furthermore, BioNTech shall be entitled to
make final decisions with respect to global trials in which patients in both the Territory and the
Retained Territory are enrolled (with our prior written consent for enrollment in the Retained
Territory) and are solely sponsored by BioNTech, provided that if such decision would increase
our financial or operational obligations in a manner not contemplated under the Development
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Plan (as defined below) or development budget, our prior written consent shall be required. In
respect of global trials in which patients in the Retained Territory are enrolled (with our prior
written consent), we are entitled to make final decisions in the Retained Territory, provided that
BioNTech’s prior written consent shall be required. For clarity, BioNTech shall not conduct
any global trial in the Retained Territory without obtaining our prior written consent, and we
have the right, in our sole discretion, to decide whether to participate in any additional global
clinical trials in relation to DB-1303 Products where we contribute patients from the Retained
Territory.
In the event a deadlock occurs with respect to the decision-making process of the JSC,
such deadlock shall be subject to binding determination by an expert panel in Hong Kong. The
expert panel shall consist of three members, one of which is appointed by each party and the
third member shall be selected by the other two members (collectively, the “ Experts ”). Each
Expert shall be a person having experience in the area of expertise in the business of
pharmaceuticals and having no conflict of interest with either BioNTech or us. The decision of
the Experts shall be final and binding on the applicable parties involved in such dispute and
deadlock resolution procedure.
Pursuant to the DB-1303 License and Collaboration Agreement, we and BioNTech agreed
to have a development plan (“ Development Plan ”) which sets forth the scope, timeline and
responsibilities of each party for DB-1303 and the DB-1303 Products in the Territory, which
may be amended upon the approval of JSC. BioNTech shall be responsible, at its own expense,
for the development of DB-1303 Products in the Territory under the oversight of JSC. To
ensure that DB-1303’s ongoing phase 1/2a global clinical trial (NCT05150691) (“ DB-1303
Ongoing Clinical Trial, ” including (i) a phase 1 clinical study, which had since been
completed, and (ii) phase 2a dose expansion study) can be conducted without interruption, the
parties have agreed that we will continue to be the sponsor of the DB-1303 Ongoing Clinical
Trial in both the Territory and the Retained Territory. Except for the DB-1303 Ongoing Clinical
Trial and other additional clinical trials for which BioNTech may designate us to be the
sponsor, BioNTech shall be the sponsor and holder of all regulatory approvals for the DB-1303
Products in the Territory, and shall lead and control the preparation and submission of all
regulatory filings related to DB-1303 and DB-1303 Products in the Territory at its sole cost and
expense. Following the completion of the DB-1303 Ongoing Clinical Trial, we shall transfer
and assign to BioNTech our right, title and interest in all regulatory approvals in the Territory
with respect to DB-1303 and DB-1303 Products. For clarity, we shall be the sponsor of any
clinical trial for DB-1303 Products conducted solely in the Retained Territory (unless
otherwise agreed), and are responsible for the preparation and submission of any regulatory
filings in the Retained Territory at our sole cost and expense. With respect to regulatory filings
for the DB-1303 Ongoing Clinical Trial that are prepared by us, we shall submit all such
regulatory filings to the JSC for its review and approval.
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Each party grants to the other party a right of reference to regulatory filings related to
DB-1303 and DB-1303 Products, for use in regulatory filings related to the DB-1303 and
DB-1303 Products. The parties have agreed under the DB-1303 License and Collaboration
Agreement and a separate data agreement for providing reasonably sufficient access to data
relating to the DB-1303 and DB-1303 Products generated pursuant to activities conducted
under the DB-1303 License and Collaboration Agreement, for regulatory approvals for
DB-1303 and DB-1303 Products.
In partial consideration of our granting of the licenses and rights to BioNTech under the
DB-1303 License and Collaboration Agreement, BioNTech has made a non-refundable upfront
payment to us. In addition, BioNTech agreed to provide funding to and reimburse us for the
reasonable costs and expenses incurred in the Territory in relation to us conducting the
DB-1303 Ongoing Clinical Trial on behalf of BioNTech, subject to the applicable cap set out
in the agreement. After the end of each calendar quarter, we shall submit to BioNTech an
invoice setting forth the amount of actual costs incurred during such quarter by or on behalf
of us performing development activities agreed under the DB-1303 License and Collaboration
Agreement in the Territory, along with supporting documentation itemizing the breakdown of
the costs and expenses that were incurred and are reimbursable hereunder. Upon BioNTech’s
request for us to conduct additional clinical studies of any DB-1303 Product, the parties shall,
through the JSC, discuss BioNTech’s funding and reimbursement of our costs and expenses
incurred in connection with such studies in the Territory and, subject to mutual agreement,
reflect these arrangements in the Development Plan. To date, we have received US$134.7
million in reimbursement from BioNTech. We are also eligible to receive payments upon the
achievement of specified development, regulatory and commercial milestones, potentially up
to an aggregate of US$857.5 million. Such milestones include: completion of the first phase II
and phase III clinical trials in the Territory for each of the initial indications, securing
marketing authorizations or approvals for a DB-1303 Product in the U.S. or other specified
jurisdictions, first achievement of certain annual net sales thresholds of DB-1303 Products in
the Territory, among other events. To date, milestone payments of US$21.0 million have been
paid under this agreement. BioNTech further agreed to pay tiered royalties between
high-single-digit to low-double-digit percentage on the annual net sales of all DB-1303
Products in the Territory (subject to certain royalty reduction adjustments) upon
commercialization. Such royalties shall be payable, on a country-by-country and product-by-
product basis, during the period beginning on the date of the first commercial sale of such
DB-1303 Product in such country and continuing until the end of the royalty term of such
DB-1303 Product in such country of sale.
Under the DB-1303 License and Collaboration Agreement, intellectual property
generated, developed, conceived solely by one of the parties or jointly by us and BioNTech
during the performance of this agreement shall be solely owned by one of the parties or jointly
and equally owned by both parties depending on inventorship, subject matter and/or by which
party it was funded. For the purpose of allocating IP ownership, inventorship shall be
determined in accordance with patent law of the United States, irrespective of where such
conception, discovery, development, or making occurs.
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The DB-1303 License and Collaboration Agreement will continue, on a country-by-
country and product-by-product basis, until the expiration of the respective royalty term for
such DB-1303 Product in such country. Upon expiration (but not early termination) of the
royalty term for a given DB-1303 Product in a given country, the license granted to BioNTech
with respect to such product in such country will automatically convert into a fully paid up,
royalty-free, perpetual, and irrevocable license (i.e., allowing permanent use of the license
granted without further payments or risk of revocation). In general, either party may terminate
this agreement in the event of the other party’s uncured material breach or insolvency.
BioNTech may also terminate the agreement without cause, in whole or in part, by giving us
prior written notice.
In general, neither expiration nor any termination of the DB-1303 License and
Collaboration Agreement shall relieve either party of any obligation or liability (including any
payment obligations) accruing prior to such expiration or termination. If the DB-1303 License
and Collaboration Agreement is terminated by BioNTech without cause, in whole or in part, the
respective license granted by us will automatically terminate. If BioNTech is confirmed to be
in uncured or non-curable material breach of the DB-1303 License and Collaboration
Agreement, we may, in our sole discretion, (i) elect to continue the DB-1303 License and
Collaboration Agreement, in which case the remaining development milestone payments by
BioNTech under the DB-1303 License and Collaboration Agreement shall automatically
increase by a certain percentage, or (ii) elect to terminate the DB-1303 License and
Collaboration Agreement, in which case the respective license granted by us will automatically
terminate. If we are confirmed to be in uncured or non-curable material breach of the DB-1303
License and Collaboration Agreement, BioNTech may (i) elect to continue the DB-1303
License and Collaboration Agreement, in which case the remaining payments by BioNTech
under the DB-1303 License and Collaboration Agreement would be reduced by a certain
percentage, or (ii) elect to terminate the DB-1303 License and Collaboration Agreement.
License and Collaboration Agreement with BioNTech for DB-1311/BNT324
On March 31, 2023, we entered into a license and collaboration agreement with BioNTech
(as may be amended from time to time, the “ DB-1311 License and Collaboration
Agreement ”), where we granted to BioNTech an exclusive, royalty-bearing and sublicensable
license under certain patents and know-how owned or otherwise controlled by us to develop,
manufacture, commercialize or otherwise exploit DB-1311 and pharmaceutical products
comprising DB-1311 (together “ DB-1311 Products ”) for all uses worldwide except Mainland
China, Hong Kong and Macau (the “ Territory ”). We retain the full rights to develop,
manufacture, commercialize and otherwise exploit DB-1311 and DB-1311 Products in
Mainland China, Hong Kong and Macau (collectively, the “ Retained Territory ”). Under the
same agreement, we also granted to BioNTech an exclusive, royalty-bearing and sublicensable
license to exploit certain patents and know-how controlled by us for the development,
manufacture and commercialization of non-ADC modalities containing the antibody sequences
in DB-1311 in the Territory, which we in-licensed from WuXi Biologics Ireland Limited
(“WuXi Biologics ”) pursuant to a license agreement we entered into with WuXi Biologics to
use its B7H3 antibody for the development of DB-1311 and potentially other B7H3-directed
drugs.
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We and BioNTech have established a joint steering committee (“ JSC”) comprised of an
equal number of representatives from each party to oversee the development, manufacture and
regulatory activities of DB-1311 Products in the Territory and, if and after we exercise the
DB-1311 Cost & Profit/Loss Sharing Option (as described below), the U.S. commercialization
of DB-1311 Products, and to facilitate information exchange under this agreement. As of the
Latest Practicable Date, the JSC comprised six members, equally represented by three members
each from our Company and BioNTech. The JSC will endeavor to make decisions by
consensus, with the representatives of each party having, collectively, one vote. If the
representatives on the JSC cannot reach an agreement, such disagreement shall be referred to
the chief executive officers of both parties for resolution. If the chief executive officers cannot
resolve such matter, we shall generally have the final decision-making authority with respect
to the development of DB-1311 and DB-1311 Products in the Retained Territory, while
BioNTech shall generally have the final decision-making authority with respect to the
development of DB-1311 Products in the Territory (including global trials where patients in
both the Territory and the Retained Territory are enrolled (with our prior written consent for
enrollment in the Retained Territory)).
In the event a deadlock occurs with respect to the decision-making process of the JSC,
such deadlock shall be subject to binding determination by an expert panel in Hong Kong. The
expert panel shall consist of three members, one of which is appointed by each party and the
third member shall be selected by the other two members (collectively, the “ Experts ”). Each
Expert shall be a person having experience in the area of expertise in the business of
pharmaceuticals and having no conflict of interest with either BioNTech or us. The decision of
the Experts shall be final and binding on the applicable parties involved in such dispute and
deadlock resolution procedure.
Pursuant to the DB-1311 License and Collaboration Agreement, we and BioNTech agreed
to have a development plan which sets forth the scope, timeline and responsibilities of each
party for DB-1311 and the DB-1311 Products in the Territory, which may be amended upon the
approval of JSC. BioNTech shall be responsible, at its own expense, for the development of
DB-1311 Products in the Territory under the oversight of JSC. The parties have agreed that we
will conduct all clinical trials for DB-1311, including those in the Territory, until the
completion of the phase II study (being the phase 2a dose expansion study) of DB-1311’s
ongoing phase 1/2a trial (NCT05914116) (together, the “ DB-1311 Planned Trials ”), provided
that if we conduct the DB-1311 Planned Trials in accordance with the DB-1311 License and
Collaboration Agreement and the development plan, BioNTech shall reimburse us for the
development costs of the DB-1311 Products in the Territory in accordance with the terms of
the agreement. Except for the DB-1311 Planned Trials and other additional clinical trials for
which BioNTech may designate us to be the sponsor, BioNTech shall be the sponsor and holder
of all regulatory approvals for the DB-1311 Products in the Territory, and shall lead and control
the preparation and submission of all regulatory filings related to DB-1311 and DB-1311
Products in the Territory at its sole cost and expense. Following the completion of a DB-1311
Planned Trial, we shall transfer and assign to BioNTech our right, title and interest in all
regulatory approvals in the Territory with respect to DB-1311 and DB-1311 Products. For
clarity, we shall be the sponsor of any clinical trial for DB-1311 Products conducted solely in
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the Retained Territory (unless otherwise agreed), and are responsible for the preparation and
submission of any regulatory filings in the Retained Territory at our sole cost and expense.
With respect to regulatory filings for the DB-1311 Planned Trials that are prepared by us, we
shall submit all such regulatory filings to the JSC for its review and approval.
Each party grants to the other party a right of reference to regulatory filings related to
DB-1311 and DB-1311 Products, for use in regulatory filings related to the DB-1311 and
DB-1311 Products. The parties have agreed under the DB-1311 License and Collaboration
Agreement and a separate data agreement for providing reasonably sufficient access to data
relating to the DB-1311 and DB-1311 Products generated pursuant to activities conducted
under the DB-1311 License and Collaboration Agreement, for regulatory approvals for
DB-1311 and DB-1311 Products.
Under the DB-1311 License and Collaboration Agreement, BioNTech has also granted us
an exclusive option to share the development and commercialization costs and profits and
losses from the exploitation of the first DB-1311 Product in the United States (the “ DB-1311
Cost & Profit/Loss Sharing Option ”), in accordance with the terms set out in the agreement.
We are entitled to exercise this option at any time during a specified period following the
completion of the first phase II clinical trial of the first DB-1311 Product (signified by the
JSC’s agreement to proceed into a phase III clinical trial). If we elect to exercise the DB-1311
Cost & Profit/Loss Sharing Option, we and BioNTech shall promptly engage in good faith
negotiations and enter into a separate cost & profit/loss sharing agreement. As of the Latest
Practicable Date, we had not exercised the DB-1311 Cost & Profit/Loss Sharing Option and
retained the right to do so in the future.
BioNTech has paid us a non-refundable upfront payment and agreed to reimburse us for
the reasonable costs and expenses incurred in the Territory in relation to us conducting the
DB-1311 Planned Trials, to the extent they are explicitly set out in the development budget or
approved in advance by the JSC. After the end of each calendar quarter, we shall submit to
BioNTech an invoice setting forth the amount of actual costs incurred during such quarter by
or on behalf of us performing development activities agreed under the DB-1311 License and
Collaboration Agreement in the Territory, along with supporting documentation itemizing the
breakdown of the costs and expenses that were incurred and are reimbursable hereunder. Upon
BioNTech’s request for us to conduct additional clinical studies of any DB-1311 Product, the
parties shall, through the JSC, discuss BioNTech’s funding and reimbursement of our costs and
expenses incurred in connection with such studies in the Territory and, subject to mutual
agreement, reflect these arrangements in the development plan. To date, we have received
US$50.1 million in reimbursement from BioNTech. We are also eligible to receive payments
upon the achievement of specified development, regulatory and commercial milestones,
potentially up to an aggregate of US$901.0 million, subject to adjustments in the event the
DB-1311 Cost & Profit/Loss Sharing Option is exercised. Such milestones include: dosing of
patients in the first phase I and phase II clinical trials in the Territory for each of the initial
indications, securing marketing authorizations or approvals for a DB-1311 Product in the U.S.
or other specified jurisdictions, first achievement of certain annual net sales thresholds of
DB-1311 Products in the Territory, among other events. To date, milestone payments of
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US$24.0 million have been paid under this agreement. BioNTech further agreed to pay tiered
royalties between high-single-digit to low-double-digit percentage on the annual net sales of all
DB-1311 Products in the Territory (subject to certain royalty reduction adjustments and
adjustments in the event the DB-1311 Cost & Profit/Loss Sharing Option is exercised). Such
royalties shall be payable, on a country-by-country and product-by-product basis, during the
period beginning on the date of the first commercial sale of such DB-1311 Product in such
country and continuing until the end of the royalty term of such DB-1311 Product in such
country of sale.
Under the DB-1311 License and Collaboration Agreement, intellectual property
generated, developed, conceived solely by one of the parties or jointly by us and BioNTech
during the performance of this agreement shall be solely owned by one of the parties or jointly
and equally owned by both parties depending on inventorship, subject matter and/or by which
party it was funded. For the purpose of allocating IP ownership, inventorship shall be
determined in accordance with patent law of the United States, irrespective of where such
conception, discovery, development, or making occurs.
The DB-1311 License and Collaboration Agreement will continue, on a country-by-
country and product-by-product basis, until the expiration of the respective royalty term for
such DB-1311 Product in such country. Upon expiration (but not early termination) of the
royalty term for a given DB-1311 Product in a given country, the license granted to BioNTech
with respect to such product in such country will automatically convert into a fully paid up,
royalty-free, perpetual, and irrevocable license (i.e., allowing permanent use of the license
granted without further payments or risk of revocation). In general, either party may terminate
this agreement in the event of the other party’s uncured material breach or insolvency.
BioNTech may also terminate the agreement without cause, in whole or in part, by giving us
prior written notice.
In general, neither expiration nor any termination of the DB-1311 License and
Collaboration Agreement shall relieve either party of any obligation or liability (including any
payment obligations) accruing prior to such expiration or termination. If the DB-1311 License
and Collaboration Agreement is terminated by BioNTech without cause, in whole or in part, the
respective license granted by us will automatically terminate. If BioNTech is confirmed to be
in uncured or non-curable material breach of the DB-1311 License and Collaboration
Agreement, we may, in our sole discretion, (i) elect to continue the DB-1311 License and
Collaboration Agreement, in which case the remaining development milestone payments by
BioNTech under the DB-1311 License and Collaboration Agreement shall automatically
increase by a certain percentage, or (ii) elect to terminate the DB-1311 License and
Collaboration Agreement, in which case the respective license granted by us will automatically
terminate. If we are confirmed to be in uncured or non-curable material breach of the DB-1311
License and Collaboration Agreement, BioNTech may (i) elect to continue the DB-1311
License and Collaboration Agreement, in which case the remaining payments by BioNTech
under the DB-1311 License and Collaboration Agreement would be reduced by a certain
percentage, or (ii) elect to terminate the DB-1311 License and Collaboration Agreement.
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License and Collaboration Agreement with BioNTech for DB-1305/BNT325
On August 4, 2023, we entered into a license and collaboration agreement with BioNTech
(as may be amended from time to time, the “ DB-1305 License and Collaboration
Agreement ”), where we granted to BioNTech an exclusive, royalty-bearing and sublicensable
license under certain patents and know-how owned or otherwise controlled by us to develop,
manufacture, commercialize or otherwise exploit DB-1305 and pharmaceutical products
comprising DB-1305 (together “ DB-1305 Products ”) for all uses worldwide except Mainland
China, Hong Kong and Macau (the “ Territory ”). We retain the full rights to develop,
manufacture, commercialize and otherwise exploit DB-1305 and DB-1305 Products in
Mainland China, Hong Kong and Macau (collectively, the “ Retained Territory ”).
We and BioNTech have established a joint steering committee (“ JSC”) comprised of an
equal number of representatives from each party to oversee the development, manufacture and
regulatory activities of DB-1305 Products in the Territory and facilitate information exchange
under this agreement. As of the Latest Practicable Date, the JSC comprised six members,
equally represented by three members each from our Company and BioNTech. The JSC will
endeavor to make decisions by consensus, with the representatives of each party having,
collectively, one vote. If the representatives on the JSC cannot reach an agreement, such
disagreement shall be referred to the chief executive officers of both parties for resolution. If
the chief executive officers cannot resolve such matter, we shall generally have the final
decision-making authority with respect to the development of DB-1305 and DB-1305 Products
in the Retained Territory, while BioNTech shall generally have the final decision-making
authority with respect to the development of DB-1305 Products in the Territory (including
global trials where patients in both the Territory and the Retained Territory are enrolled (with
our prior written consent for enrollment in the Retained Territory)).
In the event a deadlock occurs with respect to the decision-making process of the JSC,
such deadlock shall be subject to binding determination by an expert panel in Hong Kong. The
expert panel shall consist of three members, one of which is appointed by each party and the
third member shall be selected by the other two members (collectively, the “ Experts ”). Each
Expert shall be a person having experience in the area of expertise in the business of
pharmaceuticals and having no conflict of interest with either BioNTech or us. The decision of
the Experts shall be final and binding on the applicable parties involved in such dispute and
deadlock resolution procedure.
Pursuant to the DB-1305 License and Collaboration Agreement, we and BioNTech agreed
to have a development plan which sets forth the scope, timeline and responsibilities of each
party for DB-1305 and the DB-1305 Products in the Territory, which may be amended upon the
approval of JSC. BioNTech shall be responsible, at its own expense, for the development of
DB-1305 Products in the Territory under the oversight of JSC. The parties have agreed that we
will conduct all clinical trials for DB-1305, including those in the Territory, until the
completion of the phase II study (being the phase 2a dose expansion study) of DB-1305’s
ongoing phase 1/2a clinical trial (NCT05438329) (together, the “ DB-1305 Planned Trials ”),
provided that if we conduct the DB-1305 Planned Trials in accordance with the DB-1305
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License and Collaboration Agreement and the development plan, BioNTech shall reimburse us
for the development costs of the DB-1305 Products in the Territory in accordance with the
terms of the agreement. Except for the DB-1305 Planned Trials and other additional clinical
trials for which BioNTech may designate us to be the sponsor, BioNTech shall be the sponsor
and holder of all regulatory approvals for the DB-1305 Products in the Territory, and shall lead
and control the preparation and submission of all regulatory filings related to DB-1305 and
DB-1305 Products in the Territory at its sole cost and expense. Following the completion of a
DB-1305 Planned Trial, we shall transfer and assign to BioNTech our right, title and interest
in all regulatory approvals in the Territory with respect to DB-1305 and DB-1305 Products. For
clarity, we shall be the sponsor of any clinical trial for DB-1305 Products conducted solely in
the Retained Territory (unless otherwise agreed), and are responsible for the preparation and
submission of any regulatory filings in the Retained Territory at our sole cost and expense.
With respect to regulatory filings for the DB-1305 Planned Trials that are prepared by us, we
shall submit all such regulatory filings to the JSC for its review and approval.
Each party grants to the other party a right of reference to regulatory filings related to
DB-1305 and DB-1305 Products, for use in regulatory filings related to the DB-1305 and
DB-1305 Products. The parties have agreed under the DB-1305 License and Collaboration
Agreement and a separate data agreement for providing reasonably sufficient access to data
relating to the DB-1305 and DB-1305 Products generated pursuant to activities conducted
under the DB-1305 License and Collaboration Agreement, for regulatory approvals for
DB-1305 and DB-1305 Products.
In partial consideration of our granting of the licenses and rights to BioNTech under the
DB-1305 License and Collaboration Agreement, BioNTech has made a non-refundable upfront
payment to us. In addition, BioNTech agreed to reimburse us for the reasonable costs and
expenses incurred in the Territory in relation to us conducting the DB-1305 Planned Trials, to
the extent they are explicitly set out in the development budget or approved in advance by the
JSC. After the end of each calendar quarter, we shall submit to BioNTech an invoice setting
forth the amount of actual costs incurred during such quarter by or on behalf of us performing
development activities agreed under the DB-1305 License and Collaboration Agreement in the
Territory, along with supporting documentation itemizing the breakdown of the costs and
expenses that were incurred and are reimbursable hereunder. Upon BioNTech’s request for us
to conduct additional clinical studies of any DB-1305 Product, the parties shall, through the
JSC, discuss BioNTech’s funding and reimbursement of our costs and expenses incurred in
connection with such studies in the Territory and, subject to mutual agreement, reflect these
arrangements in the development plan. To date, we have received US$43.9 million in
reimbursement from BioNTech. We are also eligible to receive payments upon the achievement
of specified development, regulatory and commercial milestones, potentially up to an
aggregate of US$826.0 million. Such milestones include: completion of the first phase II and
registrational clinical trials in the Territory for each of the initial indications, securing
marketing authorizations or approvals for a DB-1305 Product in the U.S. or other specified
jurisdictions, first achievement of certain annual net sales thresholds of DB-1305 Products in
the Territory, among other events. To date, no milestone payments have become due under this
agreement. BioNTech further agreed to pay tiered royalties between high-single-digit to
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low-double-digit percentage on the annual net sales of all DB-1305 Products in the Territory
(subject to certain royalty reduction adjustments). Such royalties shall be payable, on a
country-by-country and product-by-product basis, during the period beginning on the date of
the first commercial sale of such DB-1305 Product in such country and continuing until the end
of the royalty term of such DB-1305 Product in such country of sale.
Under the DB-1305 License and Collaboration Agreement, intellectual property
generated, developed, conceived solely by one of the parties or jointly by us and BioNTech
during the performance of this agreement shall be solely owned by one of the parties or jointly
and equally owned by both parties depending on inventorship, subject matter and/or by which
party it was funded. For the purpose of allocating IP ownership, inventorship shall be
determined in accordance with patent law of the United States, irrespective of where such
conception, discovery, development, or making occurs.
The DB-1305 License and Collaboration Agreement will continue, on a country-by-
country and product-by-product basis, until the expiration of the respective royalty term for
such DB-1305 Product in such country. Upon expiration (but not early termination) of the
royalty term for a given DB-1305 Product in a given country, the license granted to BioNTech
with respect to such product in such country will automatically convert into a fully paid up,
royalty-free, perpetual, and irrevocable license (i.e., allowing permanent use of the license
granted without further payments or risk of revocation). In general, either party may terminate
this agreement in the event of the other party’s uncured material breach or insolvency.
BioNTech may also terminate the agreement without cause, in whole or in part, by giving us
prior written notice.
In general, neither expiration nor any termination of the DB-1305 License and
Collaboration Agreement shall relieve either party of any obligation or liability (including any
payment obligations) accruing prior to such expiration or termination. If the DB-1305 License
and Collaboration Agreement is terminated by BioNTech without cause, in whole or in part, the
respective license granted by us will automatically terminate. If BioNTech is confirmed to be
in uncured or non-curable material breach of the DB-1305 License and Collaboration
Agreement, we may, in our sole discretion, (i) elect to continue the DB-1305 License and
Collaboration Agreement, in which case the remaining development milestone payments by
BioNTech under the DB-1305 License and Collaboration Agreement shall automatically
increase by a certain percentage, or (ii) elect to terminate the DB-1305 License and
Collaboration Agreement, in which case the respective license granted by us will automatically
terminate. If we are confirmed to be in uncured or non-curable material breach of the DB-1305
License and Collaboration Agreement, BioNTech may (i) elect to continue the DB-1305
License and Collaboration Agreement, in which case the remaining payments by BioNTech
under the DB-1305 License and Collaboration Agreement would be reduced by a certain
percentage, or (ii) elect to terminate the DB-1305 License and Collaboration Agreement.
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Out-license and Collaboration Agreement with BeiGene on DB-1312
On July 9, 2023, we entered into an exclusive option, license and collaboration agreement
with BeiGene, Ltd. (“ BeiGene ”) (HKEX: 6160) (the “ BeiGene Agreement ”), pursuant to
which we granted to BeiGene an exclusive option to obtain a license for the development,
manufacturing, commercialization and exploitation of DB-1312, our B7-H4-targeted ADC and
all modifications, derivatives, mutations, and variants thereof that is a monospecific ADC
against B7-H4 controlled by us (the “ DB-1312 Compound ”), or any biological or
pharmaceutical product incorporating the DB-1312 Compound (the “ DB-1312 Product ”), for
all uses in humans worldwide.
On February 18, 2024 (the “ BeiGene Option Exercise Date ”), BeiGene exercised this
exclusive option, pursuant to which we granted to BeiGene (i) an exclusive, non-transferable,
royalty-bearing license, with the right to grant sublicenses, of certain know-how and patent
rights controlled by us (the “ DB-1312 Licensed IP ”), excluding patent rights specifically
related to DB-1312’s linker-payload, and (ii) a non-exclusive, non-transferable, royalty-
bearing license, with the right to grant sublicenses, of patent rights specifically related to
DB-1312’s linker-payload (together, the “ BeiGene License ”), to develop, manufacture,
commercialize and otherwise exploit any DB-1312 Compound or DB-1312 Product for all uses
in humans worldwide.
Pursuant to the BeiGene Agreement, following the BeiGene Option Exercise Date,
BeiGene shall be responsible, at its own costs and expenses, for all development activities with
respect to the DB-1312 Compounds and DB-1312 Products as permitted under the BeiGene
License. BeiGene shall be responsible, at its sole cost and expense, for the conduct of all
regulatory activities with respect to the DB-1312 Compound(s) and any DB-1312 Products for
all uses in humans worldwide.
We and BeiGene have established a Joint Steering Committee (“ BeiGene JSC ”) to
discuss the overall coordination and oversight of the activities under the BeiGene Agreement.
As of the Latest Practicable Date, the JSC comprised eight members, equally represented by
four members each from our Company and BeiGene. The BeiGene JSC will endeavor to make
decisions by consensus, with each of BeiGene and us having one vote. If the BeiGene JSC
cannot reach consensus, such matter shall be referred to the chief executive officer of both
parties (or executive officers designated by the chief executive officers) for resolution. If the
executive officers of each party are unable to resolve a matter referred to them in the event that
the BeiGene JSC fails to reach a consensus, BeiGene shall generally have the final
decision-making authority with respect to all exploitation activities related to the DB-1312
Products, subject to certain limitations.
In partial consideration of the BeiGene License, we have received an upfront payment of
US$15.0 million from BeiGene and one-time payment of US$25.0 million after it exercised the
option. We are eligible to receive payments totaling up to US$1,287.0 million upon the
achievement of certain development, regulatory and commercialization milestones set forth for
the applicable DB-1312 Product. Such milestones include: dosing of patients in the first phase
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1, phase 2 and registrational trials for each of the initial indications, submission of BLA and
receipt of BLA approvals for the first DB-1312 Product in the U.S., China and other specified
jurisdictions for each of the initial indications, first achievement of certain annual net sales
thresholds of the first DB-1312 Product worldwide, among other events. To date, milestone
payments of US$5.0 million have been paid under this agreement. Upon commercialization, we
are also eligible for tiered royalties of high-single-digit to low-double-digit percentage on the
annual net sales of each DB-1312 Product, subject to certain adjustments. BeiGene’s obligation
to make royalty payments for each DB-1312 Product in each country shall commence on the
date of first commercial sale of such DB-1312 Product in such country and continue until the
end of the royalty term of such DB-1312 Product in such country. As we in-licensed DB-1312’s
B7-H4 antibody pursuant to an agreement we entered into with Harbour BioMed Suzhou Co.,
Ltd. ( ձཔᔼᖹ(ᘽψ)ʮ̡) (currently known as Nona Biosciences (Suzhou) Co., Ltd. ( ፕ
ي(ᘽψ)ʮ̡)) (“ Harbour BioMed ”) on January 18, 2022 (as amended on October
31, 2023, the “ Harbour BioMed Agreement ”), BeiGene acknowledges and agrees that the
BeiGene License is subject to the terms and conditions of the Harbour BioMed Agreement.
BeiGene shall solely own all inventions conceived or first reduced to practice solely by
or on behalf of BeiGene and we shall solely own all inventions conceived or first reduced to
practice solely by or on behalf of us. Inventions conceived or first reduced to practice jointly
by or on behalf of BeiGene and us shall be jointly owned, with each party having the right to
freely practice and license any such jointly owned inventions without accounting to the other.
The BeiGene Agreement will remain in effect a country-by-country and product-by-
product basis, until the expiration of the royalty term applicable to such DB-1312 Product in
such country. BeiGene may terminate the BeiGene Agreement at any time in its entirety or on
a product-by-product, country-by-country basis by providing prior written notice to us. We
may terminate the BeiGene Agreement if BeiGene or its affiliates or sublicensees challenge the
validity of the patent rights under the DB-1312 Licensed IP by providing prior written notice
to BeiGene. In addition, either party may terminate the BeiGene Agreement if (i) the other
party is in material breach and fails to remedy such breach, or (ii) the other party files for
bankruptcy, faces an unresolved involuntary insolvency petition, or assigns most of its assets
to creditors.
If the BeiGene Agreement is terminated, all rights and licenses granted by us to BeiGene
pursuant to this agreement, including the BeiGene License and all other rights granted by us
to BeiGene under the DB-1312 Licensed IP shall terminate. If BeiGene has the right to
terminate this agreement due to our uncured material breach then, at BeiGene’s option, it may
elect (i) not to terminate this agreement, provided that our rights to receive and BeiGene’s
obligations to make royalty payments pursuant may be offset by the damages determined by
arbitration, or (ii) to terminate this agreement.
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Out-license and Collaboration Agreement with Adcendo on ADC Assets Utilizing Our
Proprietary Payload-linkers
On December 23, 2022, we entered into an exclusive license agreement with Adcendo
ApS, a Denmark-based biotech company focused on the development of breakthrough ADCs
for the treatment of underserved cancers (“ Adcendo ”) (as amended, the “ Adcendo
Agreement ”), pursuant to which we granted to Adcendo an irrevocable (subject to the
termination provisions therein), exclusive, royalty-bearing and sublicensable license under
certain of our technologies, including payload-linkers derived from our proprietary DITAC
platform, to develop, manufacture and commercialize Adcendo’s uPARAP-ADC product (the
“Adcendo ADC Product ”) worldwide.
Under the Adcendo Agreement, we shall have an exclusive option, by giving notice to
Adcendo at any time during a three-month period following (i) the completion of a phase 2
clinical trial, or (ii) the completion of a phase 1 clinical trial demonstrating the proof-of-
concept of the Adcendo ADC Product and the practical potential of such Adcendo ADC Product
in late-stage clinical trials, to negotiate to acquire (i) an exclusive license from Adcendo to
develop and commercialize the Adcendo ADC Product in Greater China and (ii) a non-
exclusive license from Adcendo to manufacture the Adcendo ADC Product in Greater China
(“Adcendo Granted License ”). As consideration for Adcendo Granted License, if we decide
to exercise this option, we agree to pay Adcendo an upfront payment and a milestone payment
upon our receipt of the first regulatory approval from the NMPA for an Adcendo ADC Product
in Greater China.
We and Adcendo have established a Joint Steering Committee (“ Adcendo JSC ”) to
discuss and oversee the activities under this agreement. The Adcendo JSC is composed of an
equal number of representatives from Adcendo and us. The Adcendo JSC will use good faith
efforts to promptly resolve any such matter for which it has authority. If consensus cannot be
reached, such matter may be referred for resolution to the parties’ chief executive officers. If
the chief executive officers are unable to reach an agreement, Adcendo shall have the final
decision-making authority provided that it has considered our position in good faith, and such
decision-making authority shall not be used in such a manner that would be reasonably
expected to materially increase the costs incurred by us, require us to violate any applicable
law, or is reasonably likely to give rise to a safety concern with respect to such Adcendo ADC
Product.
Subject to the terms of the Adcendo Agreement, Adcendo shall be responsible for
developing and commercializing the Adcendo ADC Product at its own cost and expense.
Adcendo shall be responsible for all regulatory activities and interaction with regulatory
authorities for the Adcendo ADC Product and will notify us of any decision by any regulatory
authorities. Adcendo will use commercially reasonable efforts to commercialize the Adcendo
ADC Product in major markets, at its sole cost and expense, unless otherwise agreed between
the parties. Upon written notice to us, Adcendo may change the antibody used in its Adcendo
ADC Product, subject to certain conditions set out in the agreement.
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In partial consideration of the Adcendo Agreement, we have received non-refundable
upfront payments. In addition, we are entitled to milestone payments up to an aggregate of
US$414.25 million upon the achievement of specified clinical, regulatory and sales milestone
events of the Adcendo ADC Product. Such milestones include: initiation of certain clinical
trials, IND clearance and regulatory approval in specified jurisdictions, and achievement of
certain annual net sales thresholds, among other events. To date, milestone payment of US$3.3
million in total has been made under this agreement. Furthermore, Adcendo agrees to pay us
tiered royalties of low-single-digit percentage on the annual net sales of the Adcendo ADC
Product, subject to certain adjustments. Such royalties will be payable on a product-by-product
and country-by-country basis until the end of the royalty term of such Adcendo ADC Product
in such region.
Under the Adcendo Agreement, each party shall solely own all inventions made solely by
its personnel. We and Adcendo shall jointly own all inventions made jointly by personnel of
both parties, provided that, subject to the rights and licenses granted under and the restrictions
set forth in the Adcendo Agreement, each party may practice and exploit any such jointly
owned invention without the consent of the other party. Inventorship shall generally be
determined in accordance with the rules of inventorship under U.S. patent law or other
applicable law.
The Adcendo Agreement will remain in effect on a product-by-product and region-by-
region basis until the expiration of the royalty term applicable to such Adcendo ADC Product
and such region, unless terminated earlier in accordance with its terms. Adcendo has the right
to terminate the Adcendo Agreement without cause upon prior written notice to us. In general,
either party may terminate the agreement upon (i) the other party’s uncured material breach of
the agreement, or (ii) the other party’s bankruptcy, insolvency or similar arrangements. Upon
termination of the Adcendo Agreement, Adcendo shall remain liable to us for all its duties and
obligations accrued prior to the termination, including all payments accrued for the
achievement of any development milestone event or sales milestone event.
We have continued to broaden and expand our collaboration with Adcendo. On November
4, 2024, Adcendo entered into a new license agreement with us to develop ADC products
directed to an additional target using our proprietary DITAC platform, with terms similar to the
existing Adcendo Agreement.
Collaboration with GSK and Avenzo
In December 2024, we entered into an exclusive option agreement with GSK for
DB-1324, a preclinical ADC asset developed with our DITAC platform. Pursuant to the
agreement, we agreed to grant GSK an exclusive option to obtain a license to develop and
commercialize DB-1324 worldwide, excluding Mainland China, Hong Kong, and Macau. GSK
paid US$30 million in upfront payment and has agreed to pay additional pre-option milestone
payments. If GSK exercises the option, we are eligible to receive an option exercise fee as well
as potential development, regulatory and commercial milestone payments totalling up to
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US$975 million, plus tiered royalties on DB-1324’s global net sales outside Mainland China,
Hong Kong, and Macau. GSK is eligible to receive potential royalties on DB-1324’s net sales
in Mainland China, Hong Kong, and Macau. As of the Latest Practicable Date, GSK had not
exercised the option.
In December 2024, we entered into a collaboration and license agreement with Avenzo,
a clinical-stage biotechnology company developing next-generation oncology therapies,
pursuant to which we granted Avenzo an exclusive license to develop, manufacture and
commercialize DB-1418, our EGFR/HER3 BsADC, globally excluding Greater China. We
have received an upfront payment of US$50 million and will be eligible to receive up to
approximately US$1.15 billion in development, regulatory and commercial milestone
payments. In addition, we are eligible to receive tiered royalties on sales in Avenzo’s territory
upon DB-1418’s commercialization.
Agreement with WuXi Biologics to In-license B7-H3 MAb
On May 26, 2022, we entered into a license agreement with WuXi Biologics Ireland
Limited (“ WuXi Biologics ”), a limited company incorporated in Ireland and an indirect wholly
owned subsidiary of WuXi Biologics (Cayman) Inc. (HKEX: 2269), which was amended,
restated and superseded by a license agreement dated March 31, 2023 between the same parties
(the “ WuXi Biologics Agreement ”). Pursuant to the WuXi Biologics Agreement, we obtained
an exclusive (even as to WuXi Biologics and its affiliates), irrevocable (subject to the
termination provisions therein), non-transferable, royalty-bearing and sublicensable license
from Wuxi Biologics to research, develop, use, manufacture, commercialize or otherwise
exploit products (“ B7-H3 ADC Products ”) that contain a B7-H3-targeted antibody validly
covered by WuXi Biologics’ certain patent rights (“ B7-H3 Antibody ”) for all uses worldwide,
including to generate ADCs (“ ADC Field ”) and other biologics modalities (together, the
“WuXi Biologics License ”). As of the Latest Practicable Date, DB-1311, one of our Core
Products and a B7-H3-targeted ADC, was the only B7-H3 ADC Product under the WuXi
Biologics Agreement.
Under the WuXi Biologics Agreement, we shall have the sole authority to determine all
regulatory plans and strategies for the B7-H3 Antibody and any B7-H3 ADC Product
worldwide. We will also be responsible as the registered holder for preparing, seeking, filing,
submitting and maintaining all regulatory approvals for the B7-H3 ADC Products worldwide
at our own expense and shall have the sole responsibility for communicating with the
regulatory authorities regarding any such regulatory approval relating to the B7-H3 ADC
Products. For clarity, as the holder of all regulatory approvals for the B7-H3 ADC Products
worldwide, we have the rights and authority to determine the commercialization strategy of
such B7-H3 ADC Products, including DB-1311, subject to the license we have granted to
BioNTech under the DB-1311 License and Collaboration Agreement, as defined and described
under “— Our Collaboration and Licensing Arrangements — License and Collaboration
Agreement with BioNTech for DB-1311/BNT324.”
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In partial consideration of the WuXi Biologics License, we have paid WuXi Biologics an
upfront payment. WuXi Biologics also received a one-time payment of US$12.0 million as a
sublicensing fee after we entered into the DB-1311 License and Collaboration Agreement.
WuXi Biologics is eligible to potentially receive milestone payments totaling up to US$56.75
million for the use of B7-H3 Antibody in the ADC Field, and up to US$39.725 million for its
use in each modality in other fields, if applicable. To date, we have paid a total of US$4.75
million in milestone payments, all of which were related to the development of DB-1311. Upon
commercialization, WuXi Biologics is eligible to receive royalties at a low-single-digit
percentage on the annual net sales of each B7-H3 ADC Product in the ADC Field and other
fields on a product-by-product and region-by-region basis, subject to certain adjustments. The
royalties shall be payable for a period from the first commercial sale of such B7-H3 ADC
Product in such region until the later of (i) the last to expire of the valid claims in the licensed
patent rights that cover the manufacture or commercialization of such B7-H3 ADC Product in
such region, (ii) the period of regulatory exclusivity for such B7-H3 ADC Product in such
region, and (iii) ten years commencing upon the first commercial sale of such B7-H3 ADC
Product in such region.
Unless otherwise agreed between the parties, inventorship of all inventions made under
the WuXi Biologics Agreement shall be determined in accordance with U.S. patent laws or
other applicable laws. We will be the sole and exclusive owner of the intellectual rights of or
claiming a B7-H3 ADC Product, any improvement to such B7-H3 ADC Product, and any
intellectual property generated, developed, conceived or reduced to practice (constructively or
actually) in connection with the performance under this agreement by or on behalf of us or our
Affiliate, whether alone or jointly with WuXi Biologics or its affiliates (“ B7-H3 Product IP ”),
unless otherwise agreed between the parties. We shall have the sole right to file patent
applications that claim a B7-H3 ADC Product or B7-H3 Product IP , and the sole right to control
the preparation, filing, prosecution, maintenance and defense of such patents worldwide. Wuxi
Biologics and its affiliates will remain the sole and exclusive owner of the intellectual property
rights licensed to us.
The WuXi Biologics Agreement will remain in effect until the expiration of the royalty
term on a product-by-product and region-by-region basis. Upon expiration of this agreement,
we shall retain the WuXi Biologics License granted to us, and such license will convert into,
non-exclusive, irrevocable, perpetual, fully-paid-up WuXi Biologics License. Before the
expiration of the royalty term, the WuXi Biologics Agreement may generally be terminated if
(i) either party reasonably believes the other party is in material breach and fails to remedy
such breach, or (ii) either party enters into liquidation, dissolution, bankruptcy, or similar
insolvency proceedings. WuXi Biologics shall have the right to terminate this agreement upon
prior written notice to us, if we indirectly or directly initiate or assist a challenge to the any
of the patents licensed to us. We may terminate this agreement upon prior written notice to
WuXi Biologics, on a region-by-region and product-by-product basis, (i) if WuXi Biologics
grants the licenses to any third party in violation of the WuXi Biologics Agreement, (ii) if a
regulatory authority in a region has ordered us to stop all development, manufacturing or
commercialization of a B7-H3 ADC Product in such region, or (iii) if in our reasonable opinion
there is a safety, patient tolerability or efficacy concern, or the profile or the commercial
viability of B7-H3 ADC Product does not justify continued development, manufacturing or
commercialization by us.
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Agreement with Harbour BioMed to In-license B7-H4 mAb
On January 18, 2022, we entered into a license agreement with Harbour BioMed Suzhou
Co., Ltd. ( ձཔᔼᖹ(ᘽψ)ʮ̡) (currently known as Nona Biosciences (Suzhou) Co., Ltd.
(ي(ᘽψ)ʮ̡)) (“ Harbour BioMed ”), a company established in the PRC and an
indirect wholly owned subsidiary of HBM Holdings Limited (HKEX: 2142) (as amended on
October 31, 2023, the “ Harbour BioMed Agreement ”). Pursuant to the Harbour BioMed
Agreement, we obtained an exclusive (even as to Harbour BioMed), royalty-bearing and
sublicensable license from Harbour BioMed to use an H2L2 antibody developed by Harbour
BioMed that targets B7-H4 (“ B7-H4 Antibody ”) to research, develop, manufacture and
commercialize any ADCs containing such B7-H4 Antibody (“ B7-H4 ADC Products ”)
worldwide (together, the “ Harbour BioMed License ”). As of the Latest Practicable Date,
DB-1312, a B7-H4-targeted ADC we out-licensed to BeiGene in 2023, was the only B7-H4
ADC Product under the Harbour BioMed Agreement. See also “— Our Collaboration and
Licensing Arrangements — Out-license and Collaboration Agreement with BeiGene on
DB-1312.”
In partial consideration of the Harbour BioMed License, we have paid Harbour BioMed
an upfront payment of US$2.0 million. Harbour BioMed also shared a single-digit percentage
of the upfront payment we received pursuant to the BeiGene Collaboration Agreement (as
defined above) for DB-1312. Harbour BioMed is eligible to potentially receive milestone
payments totaling up to US$214.7 million for the development and commercialization of each
B7-H4 ADC Product. To date, we have paid a total of US$2.3 million for the milestones
achieved by the development of DB-1312. Furthermore, Harbour BioMed is eligible to receive
royalties at a low- to mid-single-digit percentage on the annual net sales of the B7-H4 ADC
Products. The royalties shall be payable on a region-by-region basis from the first commercial
sale of such B7-H4 ADC Product in such region until the later of (i) the last to expire of the
valid patent claims under the licensed intellectual property covering the B7-H4 ADC Product
in such region, (ii) the expiration of market exclusivity for the B7-H4 ADC Product in such
region, and (iii) 15 years commencing upon the first commercial sale of the B7-H4 ADC
Product in such region (“ Harbour BioMed Royalty Term ”).
We shall be the sole owner of the intellectual rights generated in the process of our
development, manufacturing and commercialization of B7-H4 ADC Product, including any of
our improvements to the B7-H4 Antibody for the purpose of developing the B7-H4 ADC
Product.
The Harbour BioMed Agreement will remain in effect until the expiration of the license
term or completion of performance of both parties. Before the expiration of the term, the
B7-H4 Agreement may generally be terminated if (i) mutually agreed by both parties, (ii) either
party is in material breach of the Harbour BioMed Agreement and fails to remedy such breach,
(iii) either party enters into liquidation, dissolution, bankruptcy, or similar insolvency
proceedings, or (iv) we decide to terminate the development of the B7-H4 ADC Product upon
written notice to the Harbour BioMed.
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Agreement with Beijing Sinotau to In-license HER3 Antibodies
On November 29, 2021, we entered into a technology licensing and collaboration
agreement with Beijing Sinotau International Pharmaceutical Technology Co., Ltd. ( ̏ԯ΋ஷ
ʮ̡)( “ Beijing Sinotau ”) to in-license certain patents and know-how
owned or controlled by Beijing Sinotau relating to its in-house developed HER3 mAb (“ HER3
MAb Licensed IP ”) (as further amended on March 18, 2024, the “ Sinotau Mab Agreement ”).
On March 18, 2024, we entered into another technology licensing and collaboration agreement
with Beijing Sinotau to in-license certain patents and know-how owned or controlled by
Beijing Sinotau relating to its in-house developed HER3 bispecific and multi-specific
antibodies (together with the HER3 MAb Licensed IP , the “ HER3 Antibody Licensed IP ”)
(the “ Sinotau BsAb and MsAb Agreement ” and, together with the Sinotau Mab Agreement,
the “ Sinotau Agreements ”).
Pursuant to the Sinotau Agreements, we obtained an exclusive (even as to Beijing
Sinotau), royalty-bearing, irrevocable and sublicensable license from Beijing Sinotau to use
the HER3 Antibody Licensed IP to develop, manufacture, commercialize and otherwise exploit
ADC compounds (the “ HER3 ADC Compounds ”) and pharmaceutical products containing
any HER3 ADC Compound in any form, formulation or dosage form (the “ HER3 ADC
Products ” which, for clarity, comprise HER3-monospecific, bispecific and multi-specific ADC
products) globally in all uses (the “ Sinotau Licenses ”). As of the Latest Practicable Date,
DB-1310, our HER3 ADC, and DB-1418, our EGFRxHER3 bispecific ADC, were the only two
HER3 ADC Products under the Sinotau Agreements.
We shall bear all development and commercialization-related expenses for the HER3
ADC Products and are responsible for the preparation and submission of the requisite
regulatory filings, to the extent such activities are within the scope of the Sinotau Licenses.
Beijing Sinotau shall use commercially reasonable efforts to provide necessary assistance in
the process. We and Beijing Sinotau have established a Joint Steering Committee (“ Sinotau
JSC”), composed of three representatives from each of Sinotau and us, to discuss the overall
coordination and oversight of the activities under the Sinotau Agreements. The Sinotau JSC
will endeavor to make decisions by consensus. If consensus is not reached by the Sinotau JSC,
senior executives from both parties shall engage in consultation and decision-making. If
consensus still cannot be reached through good-faith negotiation, we shall have the final
decision-making authority with respect to the R&D, clinical studies, manufacturing, and
commercialization of HER3 ADC Compounds and HER3 ADC Products developed under the
Sinotau licenses. Both parties have the right to be informed of the final decisions regarding any
disagreements.
Pursuant to the Sinotau Mab Agreement, we have made an upfront payment of US$1.25
million, and are required to pay, for each HER3 ADC Product developed under this agreement,
(i) up to US$9.0 million upon the achievement of specified development and regulatory
milestones, and (ii) up to US$110.5 million upon the achievement of sales-based milestones.
Pursuant to the Sinotau BsAb and MsAb Agreement, we have made an upfront payment of
US$1.0 million. Beijing Sinotau may receive from us, for each HER3 ADC Product developed
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under this agreement, (i) up to US$5.86 million upon the achievement of specified
development and regulatory milestones, and (ii) up to US$71.83 million upon the achievement
of sales-based milestones. To date, we have paid a total of US$0.5 million for the milestones
achieved by the development of DB-1310.
Upon commercialization, Beijing Sinotau is eligible to receive royalties at a percentage
not exceeding 1% on the annual net sales of each HER3 ADC Product on a region-by-region
basis. The royalties shall be payable for a period from the first commercial sale of HER3 ADC
Product in such region until the later of (i) ten years commencing upon the first commercial
sale of such HER3 ADC Product in such region, and (ii) the loss of valid patent protection of
the HER3 Antibody Licensed IP covering the HER3 ADC Compound or HER3 ADC Product
in such region.
We shall be the sole owner of all intellectual property rights independently developed by
us in relation to (i) the HER3 ADC Compounds and HER3 ADC Products, and (ii) our ADC
technology platforms, including our improvements performed within the scope of the Sinotau
Licenses to the HER3 ADC Compounds, HER3 ADC Products, and the HER3 antibodies
licensed to us. Beijing Sinotau retains ownership of the intellectual property rights
independently developed by it outside the scope of the Sinotau Licenses in relation to the
HER3 antibodies out-licensed to us, including improvements performed to such HER3
antibodies and the relevant products. Any improvements jointly made by us and Beijing
Sinotau in relation to the HER3 ADC Compounds, HER3 ADC Products, and the HER3
antibodies licensed to us will be jointly owned by the parties.
The Sinotau Agreements will remain in effect until terminated in accordance therewith.
Either of the Sinotau Agreements may generally be terminated earlier: (i) by mutual consent,
(ii) if Beijing Sinotau is in material breach of such Sinotau Agreement and fails to remedy such
breach, in which case we are entitled to either terminate such Sinotau Agreement or elect to
retain the Sinotau Licenses by continuing to perform our contractual obligations, (iii) if we are
in material breach of the Sinotau Agreements and fail to remedy such breach, in which case
Beijing Sinotau shall have the right to terminate the Sinotau Agreements or convert the
exclusive license to a non-exclusive license, (iv) if either party enters into liquidation,
dissolution, bankruptcy, winding-up or similar insolvency proceedings, or (v) if we are in
material default of our payment obligations.
Agreement with Dartsbio Pharmaceutical to In-license B7-H3xPD-L1 BsAb
On October 9, 2022, we entered into a technology licensing and collaboration agreement
with Dartsbio Pharmaceutical (Guangdong) Co., Ltd. ( ༺ͩᖹุ(؇)ʮ̡) and its
affiliates (collectively, “ Dartsbio Pharmaceutical ”) to in-license certain patents and know-
how owned by Dartsbio Pharmaceutical relating to certain of its in-house developed
B7-H3xPD-L1 bsAbs (“ Dartsbio Licensed IP ”) (as further amended on May 15, 2023, the
“Dartsbio Agreement ”).
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Pursuant to the Dartsbio Agreement, we obtained an exclusive (even as to Dartsbio
Pharmaceutical), royalty-bearing, irrevocable, sub-licensable and transferable license to use
the Dartsbio Licensed IP and certain of Dartsbio’s B7-H3xPD-L1 bsAbs (the “ B7-H3xPD-L1
Licensed BsAbs ,” including, where applicable, the amino acid sequence, cell lines and other
related materials related to such bsAbs) to develop, manufacture and commercialize, using our
ADC technology platform, ADC products (including any derivatives or improvements thereof,
the “ B7-H3xPD-L1 ADC Products ”) worldwide (the “ Dartsbio License ”). As of the Latest
Practicable Date, DB-1419, our B7-H3xPD-L1 bispecific ADC, was the only B7-H3xPD-L1
ADC Products under the Dartsbio Agreement.
We shall bear all development and commercialization-related expenses for the B7-
H3xPD-L1 ADC Products and are responsible for the preparation and submission of the
requisite regulatory filings, to the extent such activities are within the scope of the Dartsbio
License, unless otherwise agreed between the parties. Dartsbio Pharmaceutical shall use
commercially reasonable efforts to provide necessary assistance in the process. We and
Dartsbio Pharmaceutical have established a Joint Steering Committee (“ Dartsbio JSC ”),
composed of three representatives from each of Dartsbio and us, to discuss the overall
coordination and oversight of the activities under the Dartsbio Agreement. The Dartsbio JSC
will endeavor to make decisions by consensus. If consensus is not reached by the Dartsbio JSC,
senior executives from both parties shall engage in consultation and decision-making. If the
senior executives are unable to reach a consensus, we shall have the final decision-making
authority on matters within the scope of the Dartsbio License. For matters outside the scope of
the Dartsbio License or where Dartsbio Pharmaceutical retains rights that do not affect our
rights and interests under the Dartsbio Agreement, Dartsbio Pharmaceutical shall have the final
decision-making authority. Both parties have the right to be informed of the final decisions
regarding any disagreements.
Pursuant to the Dartsbio Agreement, we have made an upfront payment of US$0.5 million
and are required to pay technology transfer milestone payments of up to an aggregate of
RMB9.0 million contingent on the progress of such transfer. Dartsbio Pharmaceutical may
receive from us, for each B7-H3xPD-L1 ADC Product, (i) up to US$20.5 million upon the
achievement of specified development and regulatory milestones, and (ii) up to US$15.0
million upon the achievement of sales-based milestones. To date, we have paid a total of
US$1.0 million in milestone payments, all of which were related to the development of
DB-1419. Upon commercialization, Dartsbio Pharmaceutical is eligible to receive tiered
royalties at a percentage not exceeding 2% on the annual net sales of each B7-H3xPD-L1 ADC
Product on a product-by-product and region-by-region basis. The royalties shall be payable for
a period from the first commercial sale of such B7-H3xPD-L1 ADC Product in such region
until the earliest of (i) the expiration of valid claims which may arise from the infringement
due to the importation, manufacture, use, sale, or offer for sale of the B7-H3xPD-L1 Licensed
BsAb in such region; (ii) the expiration of regulatory exclusivity for the B7-H3xPD-L1
Licensed BsAb in such region; or (iii) ten years following such first commercial sale of the
B7-H3xPD-L1 ADC Product in such region.
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We shall be the sole owner of all intellectual property rights generated in development,
manufacture or commercialization of the B7-H3xPD-L1 ADC Products by us, including any
improvements performed within the scope of the Dartsbio License to the B7-H3xPD-L1
Licensed BsAbs. Dartsbio Pharmaceutical retains ownership of the intellectual property rights
independently developed by it in relation to the B7-H3xPD-L1 Licensed BsAbs. Dartsbio
Pharmaceutical will also own improvements performed outside the scope of the Dartsbio
License to the B7-H3xPD-L1 Licensed BsAbs and Dartsbio Licensed IP .
The Dartsbio License will remain in effect until the expiration of the license term, unless
the Dartsbio Agreement is terminated earlier. The Dartsbio Agreement may generally be
terminated: (i) by mutual consent, (ii) if either party is in material breach of the Dartsbio
Agreement and fails to remedy such breach, (iii) if either party enters into liquidation,
dissolution, bankruptcy, winding-up or similar insolvency proceedings, or (iv) if we are in
material default of our payment obligations.
RESEARCH AND DEVELOPMENT
We conduct R&D activities primarily through our in-house R&D team. We also engage
contract research organizations (“ CROs ”) from time to time to support our preclinical research
and clinical trials. In addition, we have established an array of strategic partnerships to
accelerate the development of our pipeline across key global markets, expand our global
clinical development capabilities, and fuel our future innovation and long-term growth. See “—
Our Collaboration and Licensing Arrangements” for details.
In 2023 and 2024, our costs and expenses in relation to R&D activities, which represented
our cost of revenue and research and development expenses, were RMB986.7 million and
RMB1,993.3 million, respectively. In particular, costs and expenses in relation to R&D
activities incurred for our Core Products were RMB635.3 million and RMB1,275.3 million
during the same periods, respectively, accounting for 64.4% and 64.0% of our total costs and
expenses in relation to R&D activities for the corresponding periods. In 2023 and 2024, our
research and development expenses accounted for 89.9% and 84.1% of our total operating
expenses (which equals the sum of research and development expenses and administrative
expenses), respectively.
In-house R&D Team
As of December 31, 2024, our in-house R&D team consisted of 131 members across PRC
and the U.S., over 80% of whom held a doctoral or master’s degree, mainly in medical science,
biology, pharmacology, and chemistry and other related fields. The average industry experience
of our R&D team is over 12 years. We place a strong emphasis on academic qualifications,
industry experience, and complementary expertise when building our R&D team, which has
allowed us to assemble strong talent that can effectively leverage their accumulated expertise
across all aspects of drug R&D.
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Notably, our R&D leadership have extensive prior experience in ADC research and a
demonstrated track record contributing to the advancement of this innovative drug modality.
Our in-house R&D team is led by Dr. QIU Y ang, our chief scientific officer, Dr. MU Hua, our
global chief medical officer, Ms. GU Wei, our chief medical officer, and Dr. HUA Haiqing, our
senior vice president and head of drug discovery:
 Dr. QIU Y ang drives the scientific direction of our pipeline programs, with over two
decades of experience in drug discovery and translational medicine at MNCs. Prior
to joining us, Dr. Qiu served as co-chair of the cross-functional ADC forum and
senior director of translational medicine at Daiichi Sankyo, where she was a leading
contributor to the development of innovative ADC therapy, most notably HER3-
DXd (U3-1402, patritumab deruxtecan), which received FDA Breakthrough Therapy
Designation in 2021. Before Daiichi Sankyo, Dr. Qiu held key positions as director
and head of biomarker research at Janssen China Discovery Center and director
leading the progress of early drug discovery at GSK R&D China. Throughout her
distinguished career, Dr. Qiu has demonstrated success in leading drug discovery,
translational medicine, and early clinical development programs, contributing to the
discovery and advancement of over 15 drug candidates into clinical trials and the
approval of multiple innovative drugs. Dr. Qiu’s understanding of the ADC
landscape and track record are foundational to our continued success as we develop
cutting-edge ADC technologies that transform patient care.
 Dr. MU Hua leads our global clinical development team and oversees our clinical
development strategies. With decades of global experience in pharmaceutical
research, translational medicine and clinical development, Dr. Mu held leadership
roles at renowned MNCs, biopharmaceutical companies and investment firms,
including Genentech, Inc., WuXi AppTec Co., Ltd. (HKEX: 2359), and Simcere
Pharmaceutical Group Limited (HKEX: 2096) or their respective subsidiaries. Prior
to joining us, Dr. Mu served as chief executive officer, interim chief medical officer
and China head at Zenas BioPharma Inc. (Nasdaq: ZBIO). His extensive experience
as a seasoned biotechnology executive and drug developer provides strategic vision
for us to advance efficient clinical development programs and navigate regulatory
landscapes.
 Ms. GU Wei brings over ten years of expertise in clinical development across the
globe, highlighted by her extensive experience leading numerous clinical studies.
Ms. Gu has built a successful track record for clinical development at renowned
MNCs, including Boehringer Ingelheim, AstraZeneca, and Bristol Myers Squibb,
and her strategic oversight plays a key role in our efficient trial execution and
alignment with regulatory standards. Earlier in her career, Ms. Gu had six years of
physician experience at a top-grade hospital in China.
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 Dr. HUA Haiqing leads our strategies for novel drug discovery and CMC
development. Over the past 15 years, Dr. Hua has established a strong track record
of leading the discovery of innovative drugs and advancing them into the clinic.
Prior to joining us, Dr. Hua held senior positions at Hansoh Pharma and as a
principal scientist at Lilly China R&D Center. Dr. Hua’s extensive experience and
leadership in drug discovery and CMC development contribute to the seamless
integration of cutting-edge science with robust manufacturing processes, facilitating
the efficient translation of our ADC research into transformative therapies.
Our in-house R&D team consists of several key functionalities, including drug research
and clinical development. The following table sets forth the composition of our R&D team as
of December 31, 2024:
R&D Centers Number % of total
Drug research /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111853 40.5%
China /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111848 36.6%
U.S. /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 3.8%
Clinical development /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111878 59.5%
China /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111864 48.9%
U.S. /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 10.7%
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/H1118131 100.0%
During the Track Record Period and up to the Latest Practicable Date, substantially all
key R&D personnel involved in the research and development of our Core Products, DB-1303
and DB-1311, remained employed by us.
Industry-leading Scientific Advisory Board
We have built strong relationships with renowned industry experts. Regularly, we engage
our scientific advisory board of distinguished scientists to advise on our research strategy and
clinical development plan. Our scientific advisory board is led by Dr. Antoine Y ver and Dr. Pasi
A. Jänne, two leading minds in ADC drug development in the world, and Dr. Su Ling, a
distinguished expert in drug development and regulatory affairs:
 Dr. Antoine Yver is the chairman of our scientific board. Dr. Y ver is a world-leading
scientist in ADC research and development with over 34 years of pharmaceutical
experience. Dr. Y ver formerly served as the executive vice president, global head of
oncology R&D and chair of the cancer enterprise at Daiichi Sankyo from 2016 to
2021, where his strategic leadership transformed Daiichi Sankyo from a small
molecule drug company to a world-class oncology company. Dr. Y ver was the vision
leader for Daiichi Sankyo’s ADC pipeline and led the successful accelerated and
practice-changing development of Enhertu
® (trastuzumab deruxtecan). He
previously had been a senior vice president and head of oncology global medicines
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development at AstraZeneca, where he led equally successful development and
approvals of TAGRISSO ® and L YNPARZA ®. In addition, he held various clinical
development roles at Johnson & Johnson, Schering-Plough, Aventis Group and
Rhone Poulenc Rorer. Dr. Y ver is currently an independent director at Sanofi, a
member of the scientific committee of Institut Gustave Roussy at Paris, France, as
well as board member or special advisor to various companies.
 Dr. Pasi A. Jänne is a world-renowned medical oncologist and translational
scientist. Dr. Jänne is currently a professor of medicine at Harvard Medical School,
the senior vice president for translational medicine and a director of the Belfer
Center for Applied Cancer Science, and an active thoracic medical oncologist within
the Lowe Center for Thoracic Oncology, at the Dana-Farber Cancer Institute. As a
leading PI of early clinical development, he has 25 years of experience in early
clinical development and translational research for oncology drugs, with a particular
focus on lung cancer. He has made seminal therapeutic discoveries, including as one
of the inventors of patents on EGFR mutations. Dr. Jänne has also contributed
instrumentally to the development of several innovative drugs, including HER3-
DXd of Daiichi Sankyo, TAK-788 of Takeda Pharmaceutical, osimertinib of
AstraZeneca, crizotinib of Pfizer, trastuzumab deruxtecan of Daiichi Sankyo and
AstraZeneca and adagrasib of Mirati Therapeutics and Bristol Myers Squibb.
 Dr. SU Ling , Ph.D., FDIA. Dr. Su has over 30 years of experience in drug regulatory
and clinical development. Early in his career, he worked in the Bureau of Drugs of
the Ministry of Health, PRC (၍ଣ҅) and in Center for Drug
Evaluation, Food and Drug Administration, U.S. Since 1996, Dr. Su spent 16 years
in various R&D and management positions in multinational pharmaceutical
companies, both in US and China, including an epidemiologist in Merck U.S., a
medical director in Merck Sharp & Dohme China, a senior global regulatory strategy
director at Merck U.S., a pharma development and medical director at Roche
Shanghai, a vice president for Asia Pacific clinical research at Wyeth, and a senior
vice president and head of Greater China pharma development at Novartis. During
2012 to 2016, Dr. Su was a life science strategic advisor in Sidley Austin LLP . Since
2016, Dr. Su has been a venture partner in Lilly Asia V entures. Since 2022, he has
been serving as the chief development officer at Skyline Therapeutics. Dr. Su was
elected as the president of Drug Information Association (“ DIA”), a global
professional association focusing on healthcare product development, during 2012
to 2013, and served on the board of directors of DIA during 2008 to 2014. He is
currently a fellow of DIA. Dr. Su received his bachelor’s degree in pharmacology
from Shanghai Medical University, PRC, his master’s degree in drug clinical
development and Ph.D. in epidemiology from University of North Carolina at
Chapel Hill.
With the deep relationships we have built, Dr. Y ver, Dr. Jänne and other members of our
scientific advisory board have shared years of knowledge and insights that have been
instrumental in our pipeline R&D, clinical development and global collaboration.
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R&D Process
We have formulated a comprehensive in-house R&D system, which sets forth procedures
governing key aspects of the drug development process. Key steps of the R&D process for our
ADC candidates are set forth below.
 Target identification/validation and drug discovery. Before initiating an ADC
candidate R&D project, we leveraged insights from our seasoned scientists to
identify targets with high potential. For each identified target, we will conduct a
comprehensive analysis to assess market size, patentability, competitive landscape,
and potential risks, ensuring strategic alignment and high success potential. Our
rigorous target validation includes assessment of scientific rationale, risk and safety
considerations, commercial viability, and future clinical and regulatory plans.
After target identification and validation, we will conduct a comprehensive drug
discovery process including antibody discovery, ADC engineering, as well as
evaluation of systemic stability, tumor-specific payload release, direct and
bystander-killing effects, in vivo efficacy and safety.
 Preclinical research and translational medicine. During the preclinical stage, we
assess PK, toxicity, pharmacology, and safety through in vitro and animal studies,
making informed decisions about advancing candidates and setting key development
milestones. Our translational medicine team bridges the gap between preclinical
research and clinical application. Their interdisciplinary research encompasses a
wide range of studies from drug metabolism and pharmacokinetics (“ DMPK ”),
toxicology and biomarker development, to quantitative and clinical pharmacology.
Our translational medicine team plays a key role in improving the success rates,
time-efficiency and cost-effectiveness of our clinical trials.
In addition, we have built an AI team to support our R&D efforts with a large
language model-based, machine learning approach. We will continue to invest into
our dedicated computational infrastructure with integrated AI capabilities, based
upon iterative learning through both our “Duality Target Engine,” that comprises
comprehensive omics computational analysis and automatic literature review, and
“Duality Knowledge Base and Retrieval-Augmented Generation Chatbot,” that
centralize internal data and knowledge repositories to further improve efficiency and
accuracy of R&D. By utilizing powerful AI-driven tools and data-based support, we
aim to systematically optimize every stage of our R&D, from target identification,
ADC design and engineering to biomarker discovery, enabling us to finetune our
engineering of next generation ADC candidates to prioritize high-potential targets
and indications.
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 Clinical development. During clinical trials, we maintain close communication with
trial sites and principal investigators to ensure adherence to study protocols and
good clinical practice (“ GCP”) guidelines. We select reputable principal
investigators, clinical trial institutions and hospitals based on their quality,
resources, expertise, and patient availability. Additionally, our regulatory affairs
team oversees the registration strategy and submission processes required by
regulatory authorities, maintaining continuous dialogue with regulatory authorities.
We also maintain close communication with these authorities, including the NMPA
and the FDA, so as to closely follow the regulatory requirements for IND and
NDA/BLA approvals.
 CMC and quality management. We have implemented comprehensive CMC testing
protocols to ensure consistent quality across our ADC batches. These measures
include monitoring the number of payloads attached to each antibody, checking the
purity and stability of the payload, analyzing the antibody structure, and conducting
various tests to verify the final product’s physical appearance, chemical properties,
and biological effectiveness under different storage conditions. See also “— Social,
Health, Work Safety and Environmental Matters — Manufacturing and Quality
Management.”
Collaboration with CROs
In addition to our in-house R&D activities, we also collaborate with reputable CROs to
manage, conduct, and support our preclinical research and clinical trials. The services they
provide under our oversight include site management, patient recruitment, and
pharmacovigilance for our clinical trials, as well as preclinical and clinical laboratory testing
and other specialized tasks aligned with our needs. During the Track Record Period, we
collaborated with over 200 CROs.
When selecting CRO partners, we consider a range of factors such as their professional
qualifications, relevant research experience, service quality and efficiency, industry reputation,
and pricing competitiveness. Depending on the specific services required, we enter into
project-based service agreements with our CROs that outline the detailed scope of work,
sample size, procedures, deliverables, timelines, and payment terms. Many CROs we
collaborate with are among the leading and well-recognized players in the industry.
We maintain close supervision of our CRO partners to ensure their performance fully
complies with our protocols and all applicable regulations. We hold regular meetings with
CROs to keep track of project progress and execution details and conduct periodic audits on
them. This rigorous oversight helps protect the integrity and authenticity of the data generated
from our trials and studies.
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We currently expect to continue in the engagement of our key existing CROs and do not
expect delays from them within or outside China. To the best knowledge of our Directors,
except for WuXi Biologics (Cayman) Inc., our CROs are independent of the Company. Wuxi
V enture, a wholly-owned subsidiary of WuXi Biologics (Cayman) Inc. is one of our
Shareholders. For details, see “History and Corporate Structure — Pre-IPO Investments —
Information regarding the Pre-IPO Investors.”
Key terms of our agreements that we typically enter into with our CROs are set forth
below.
 Services. The CRO provides us with ancillary services in the course of our
preclinical studies and clinical trials, such as implementing animal studies,
providing clinical support, record keeping and report preparation.
 Term. The CRO is required to perform its services within the prescribed time limit
set out in each work order, usually on a project basis.
 Payments. We are required to make payments to the CROs in accordance with a
payment schedule agreed by the parties.
 Intellectual property rights. We generally own the intellectual property rights
arising from the projects conducted by the CROs within the stipulated work scope.
R&D Facilities
Our R&D activities were primarily conducted in China and the U.S.. Our Suzhou facility
serves as the core of our R&D activities, housing our key technology platforms and
well-equipped research laboratory to support our drug discovery, preclinical, and clinical
needs. In addition to this central R&D hub, we also conduct R&D activities across Shanghai,
Beijing, and the U.S. The collective efforts across our multi-regional research infrastructure
and operations are instrumental to the rapid, smooth and efficient execution of our drug
development plans in China and globally.
MANUFACTURING
To date, our manufacturing activities are conducted through contract development and
manufacturing organizations (“ CDMOs ”) to support our drug development process. We
currently outsource our manufacturing activities to industry recognized CDMOs in China. We
intend to continue this practice in the near term and at the initial stage of commercialization,
as we believe it is cost-effective and efficient to engage CDMOs for manufacturing activities
and enables us to focus on, and allocate our resources to, the discovery and clinical
development of our ADC candidates. We plan to continue to work together with our
industry-leading CDMO partners to optimize our manufacturing process, technologies, and
know-how to enhance product quality, improve cost efficiency, and shorten the time from
bench to bedside. We have maintained a relationship with the majority of our six existing
CDMOs for over three years.
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When selecting CDMOs we take into account a number of factors, including
manufacturing capacity, qualifications, geographic, track record, adherence to applicable
regulations and standards, as well as compatibility with our R&D priorities. We conduct quality
assurance audit programs to ensure monitor and evaluate the services of our CDMOs.
We enter into long-term master service agreements with our CDMO partners. We then
place specific orders as our R&D activities progress. Key terms of our agreements that we
typically enter into with our CDMOs are set forth below.
 Services. The CDMOs provide us with manufacturing services according to the
types of deliverables, location, unit price, volume and requested delivery date
specified by us.
 Quality control and inspections. We are entitled to conduct on-site audits and
regular inspections to ensure compliance of our CDMOs with the relevant current
good manufacturing practice (“ cGMP ”) and regulatory requirements.
 Payments. We are required to make payments to the CDMOs in accordance with the
payments schedule set forth in the agreement, which is typically linked to the stages
of the manufacturing process and the deliverables we receive.
 Intellectual property rights. We own all intellectual property rights relating to our
products arising from the outsourced manufacturing processes.
 Remedies for non-conforming products. Remedies for non-conforming products.
We are entitled to remedies for products that fail to conform to our specifications.
The CDMOs are required to replace the non-conforming products and compensate
us for any direct losses due to the delay.
For risks relating to our relationship with CDMOs, see “Risk Factors — Risks Relating
to Dependence on Third Parties — We may rely on third parties to manufacture our drug
products for clinical development and commercial sales and to provide a stable and adequate
supply of quality materials and products for our drug development and commercialization
needs. Our business could be harmed if these third parties suffer substantial disruption to
supply chain and production facilities, encounter problems in manufacturing or fail to deliver
sufficient quantities of product or at acceptable quality or price levels” for details.
QUALITY MANAGEMENT
We maintain a comprehensive quality management system which is developed and
continuously refined to meet the stringent regulations and guidelines in China, the U.S., and
Europe. We closely monitor the evolving cGxP standards and regulatory changes in these key
markets, updating our internal procedures accordingly. Our quality management procedures
span all key stages of the ADC development process.
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We carry out our R&D activities in compliance with detailed quality control and quality
assurance procedures to comply with relevant regulatory requirements and our internal
standards. We maintain documentation of our R&D activities to ensure proper records are
maintained for regulatory submissions and audits. For the manufacturing process, we conduct
rigorous qualification and selection of raw material suppliers and ensure raw materials are
tested and verified before entering the manufacturing process. We regularly audit and inspect
CDMOs to verify that their processes align with our quality requirements and regulatory
standards. Furthermore, we provide trainings for our quality and research and development
teams to keep them updated on the latest quality standards and regulatory requirements.
COMMERCIALIZATION
As of the Latest Practicable Date, we had not obtained marketing approval for any drug
candidates, nor had we generated any revenue from product sales. Anticipating
commercialization of our late-stage ADCs in the next few years, we plan to maximize the value
of our drug candidates by selecting the optimal commercial model, including building our
in-house commercialization capabilities, and/or collaboration with third parties such as
distributors, CSOs, and licensing partners.
DB-1303, one of our Core Products, is projected to file for accelerated approval with the
FDA as early as 2025 as a treatment for HER2-expressing EC. DB-1303 is the most clinically
advanced HER2 ADC candidate globally that targets EC across HER2-expression levels,
according to Frost & Sullivan, with potential for extension to other underserved cancer
indications. We are also developing DB-1311, our other Core Product, which is currently one
of the top three B7-H3 ADCs undergoing global MRCTs in terms of clinical development
progress for advanced SCLC, according to Frost & Sullivan.
Partnership with 3SBio to Commercialize DB-1303 in the China Market
On January 10, 2025, we entered into a collaboration agreement with 3SBio Inc.
(HKEX: 1530, “ 3SBio ”) through its subsidiaries (the “ 3SBio Collaboration Agreement ”),
pursuant to which we have appointed 3SBio as our commercialization partner in Mainland
China, Hong Kong, and Macau (the “ Territory ”) to promote DB-1303 for certain indications.
Such promotion generally encompasses activities directed at healthcare professionals and other
promotional and sales channels for DB-1303 (which, for the avoidance of doubt, does not
include the actual sales of drug products). 3SBio will also provide related commercialization
services to support DB-1303’s market access, medical affairs, channel management and other
commercial activities in the Territory.
We retain all rights related to DB-1303 not expressly granted to 3SBio, including the
exclusive rights to (i) conduct R&D, regulatory (including as Marketing Authorization Holder),
and manufacturing activities for DB-1303 in the Territory, and promote DB-1303 outside the
Territory; (ii) maintain responsibility for DB-1303’s sales and distribution activities, except
where 3SBio is authorized to provide assistance for channel management, distributor
recommendations, and other limited functions as specified in the 3SBio Collaboration
Agreement; and (iii) perform safety monitoring and pharmacovigilance, provided that 3SBio’s
ability to carry out its responsibilities with respect to pharmacovigilance is not impeded.
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We and 3SBio have established a joint steering committee (“ JSC”) comprised of three
representatives from each party to oversee the strategic direction of DB-1303’s
commercialization activities and monitor the performance of the 3SBio Collaboration
Agreement. JSC decisions shall generally require unanimous approval of both parties, with
representatives from each party having one collective vote. If the JSC is unable to reach
consensus, the matter will be escalated to both parties’ chief executive officers or their
authorized representatives for resolution. If an agreement still cannot be reached, we shall have
final decision-making authority on: (i) DB-1303’s branding strategies, as well as patient
assistance and service programs, (ii) reviewing and approving 3SBio’s proposed commercial
channel strategies and its recommended distributors, and overall channel management within
the Territory, (iii) initial product pricing, (iv) post-launch multi-center investigator-initiated
clinical trials and real-world studies, (v) reviewing and approving promotional materials
submitted by 3SBio, and (vi) all matters that fall within the authority of the Marketing
Authorization Holder under the applicable laws and regulations.
3SBio agrees to use commercially reasonable efforts to promote DB-1303 and carry out
its obligations under the 3SBio Collaboration Agreement, including: (i) developing detailed
promotional plans for JSC approval, and executing JSC-approved promotional plans; (ii)
consulting with us on channel management principles and processes, and recommending
distributors for product channel management; (iii) implementing market access strategies and
initiatives approved by the JSC or jointly developed by the parties (including participation in
NRDL negotiations and volume-based procurement programs); (iv) jointly developing
reasonable pricing strategies and annual sales targets through the JSC; and (v) providing
support in pharmacovigilance and adverse event reporting.
In partial consideration of the 3SBio Collaboration Agreement, 3SBio has paid us a
non-refundable upfront payment of US$25 million. We agree to pay 3SBio a service fee
calculated as a tiered percentage of DB-1303’s net sales in the Territory in exchange for the
promotion and commercialization services they provide, subject to performance-based
adjustments determined through a comprehensive KPI assessment framework evaluating,
among other defined metrics, sales target achievement, hospital coverage expansion, and
resource deployment. We are eligible to receive payments from 3SBio upon the achievement
of specified development and regulatory milestones, potentially up to an aggregate of US$42.0
million, as well as potential sales-based milestone payments.
We have granted 3SBio the rights to use our designated trademarks and intellectual
property rights related to DB-1303 within the Territory for the sole purpose of facilitating its
performance of the 3SBio Collaboration Agreement, and such rights shall be non-transferable
and non-sublicensable. Any intellectual property arising from the performance of the 3SBio
Collaboration Agreement by the parties that relates to DB-1303 shall be solely owned by us,
regardless of how such intellectual property is conceived and developed, whether individually
or jointly by either or both parties.
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The initial term of the 3SBio Collaboration Agreement shall be 15 years, commencing
from the date we deliver the first commercial batch of DB-1303 following its first marketing
approval (including conditional approval) in Mainland China. The initial term may be extended
for additional five-year period(s) upon mutual agreement. The 3SBio Collaboration Agreement
may be terminated with immediate effect by mutual agreement. Additionally, either party may
terminate the agreement upon the other party’s uncured material breach or insolvency, or if the
parties cannot reach a resolution upon a force majeure event, among other circumstances
specified in the 3SBio Collaboration Agreement.
BUSINESS DEVELOPMENT
We have a dedicated business development team led by Mr. W ANG Xin, our chief
business officer, who has over 20 years of expertise in healthcare research and cross-border
corporate advisory roles. In our short operating history, we have entered into several
out-licensing and collaboration deals with leading industry players worldwide to date,
including BioNTech, BeiGene, Adcendo, GSK, and Avenzo, with over US$6.0 billion in total
deal value (of which approximately US$500 million had been received as of the Latest
Practicable Date). Additionally, we have strategically in-licensed advanced antibody
technologies to enhance our drug development efficiency, while complementing our in-house
capabilities in antibody research and drug discovery. While using in-licensed antibody
components, we retain independence over the development of our novel ADC assets. Our
in-licensing agreements are carefully structured to ensure we maintain ownership and control
over our ADC assets and the intellectual property generated during drug development,
including the ability to out-license the full drug candidate. For further details, see “— Our
Collaboration and Licensing Arrangements.”
We will continue to implement our hybrid model of external collaboration and internal
development to maximize the clinical and commercial value of our programs. For details, see
“— Our Business Strategies — Maximize clinical and commercial potential of our assets
through value accretive partnerships.”
INTELLECTUAL PROPERTY
We are committed to the development and protection of our intellectual properties. Our
future success depends significantly on our ability to obtain and maintain robust patent
coverage, as well as other forms of intellectual property and proprietary protections, for the key
technologies, inventions, and know-how fundamental to our ADC pipeline and technology
platforms. Equally important is our capacity to defend and enforce these patents, preserve the
confidentiality of our trade secrets, and ensure our freedom to operate without infringing upon,
misappropriating, or otherwise violating the valid and enforceable intellectual property rights
held by third parties.
BUSINESS
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We have a global portfolio of patents to protect our drug candidates and technologies. As
of the Latest Practicable Date, we owned (i) four issued patents in China, (ii) six issued patents
in the U.S., (iii) three issued patents in other jurisdictions, and (iv) 160 patent applications,
including 40 in China, eight in the U.S., 19 under the Patent Cooperation Treaty (“ PCT”), nine
in Europe, and 84 in other jurisdictions.
As of the Latest Practicable Date, with respect to our two Core Products, DB-1303 and
DB-1311, we owned four issued patents in China and six issued patents in the U.S., two issued
patents in other jurisdiction, and also had 40 patent applications (30 of which are owned by us
and ten of which are in-licensed from our collaboration partners), including three in China, one
in the U.S., two pending PCT patent applications, and 34 in other jurisdictions. These patents
and patent applications owned or in-licensed by us cover material aspects of our Core Products.
The following table summarizes the details of the material granted patents and patent
applications in connection with our Core Products and our technology platforms. For more
details, please see “Appendix IV — Statutory and General Information — B. Further
Information about Our Business — 2. Intellectual Property Rights — (ii) Patents.”
Related product
Patent/patent
application (1) Category
Patent/patent
application number Jurisdiction
Patent holder/
applicant
Application
date
Date of
grant
Expiration
date (2)
DB-1303 /H1118/H1118/H1118/H1118Anti-tumor Compound and
Preparation Method and
Application Thereof
(ʿՉ
ձᏐ͜)
Invention
patent
CN115925796B PRC Duality Suzhou Sept. 29,
2021
May 31,
2024
Sept. 28,
2041
DB-1303 /H1118/H1118/H1118/H1118Anti-tumor Compound and
Preparation Method and
Use Thereof
Invention
patent
US11685742B2 U.S. Duality Suzhou Sept. 29,
2021
Jun. 27,
2023
Sept. 28,
2041
DB-1311 /H1118/H1118/H1118/H1118Anti-tumor Compound and
Preparation Method and
Use Thereof
Invention
patent
US11607459B1 U.S. Duality Suzhou Sept. 29,
2021
Mar. 21,
2023
Sept. 28,
2041
DB-1311 /H1118/H1118/H1118/H1118Anti-B7H3 Antibody-Drug
Conjugates and Uses
Thereof ( ҤB7H3 Ҥ᜗-ᖹ
ʿՉ͜௄)
(3)
Invention
patent
PCT/CN2023/098596 PCT Duality Suzhou Jun. 6,
2023
N/A N/A
DITAC and
DIBAC /H1118/H1118/H1118/H1118
Antitumor Compound, and
Preparation Method
Therefor and Use Thereof
(ʿՉ
ձᏐ͜)
(4)
Invention
patent
PCT/CN2021/121721 PCT Duality Suzhou Sept. 29,
2021
N/A N/A
DIMAC /H1118/H1118/H1118/H1118/H1118Steroid Compound and
Conjugate Thereof
(ʿՉၢ
ي)
5)
Invention
patent
PCT/CN2022/114855 PCT Duality Suzhou Aug. 25,
2022
N/A N/A
BUSINESS
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Notes:
(1) Each of these patents/patent applications protects, among others, the structures of the whole ADC
molecules. Additionally, most of these patents/patent applications also protect the payload component
of the relevant ADC candidates, preventing competitors from commercializing ADCs using payloads
that are identical to or within the scope of the protected payloads. This comprehensive, multi-layered
approach enhances the exclusivity and competitive positioning of our ADC portfolio.
(2) Patent expiration date does not include any applicable patent term extensions.
(3) PCT patent application which has the opportunity to enter national phases within specified deadline.
(4) PCT patent application which has entered national phases in various jurisdictions.
(5) We are applying for patent in relation to our DUPAC platform.
We conduct our business under the brand name of “Duality (ࢸ݈As of the Latest
Practicable Date, we had (i) 41 registered trademarks in China, (ii) 20 trademark applications
in China, and (iii) five trademark applications in other jurisdictions. We are also the registered
owner of one domain name.
We have entered into license and collaboration arrangements with our business partners,
through which we may grant access to our own intellectual property or gain access to the
intellectual property of others. See “— Our Collaboration and Licensing Arrangements.”
We have engaged IP counsel to oversee comprehensive planning and development of our
intellectual property portfolio, with the objective of mitigating IP-related risks. Furthermore,
our employment contracts contain specific intellectual property provisions prohibiting
employees from infringing third-party intellectual property rights, including those of their
former employers.
During the Track Record Period and up to the date of this prospectus, except as disclosed
under “— Legal Proceedings and Compliance,” neither our Company nor, to the best
knowledge of our Directors, our R&D personnel had been involved in any proceedings in
respect of any claims of infringement of any intellectual property rights which may have a
material adverse effect on our business, financial condition and results of operations. See also
“Risk Factors — Risks Relating to Intellectual Property Rights — We may from time to time
be involved in legal proceedings and disputes to protect or enforce our intellectual property
rights, or defend against infringement and other claims alleged by third parties, which could
be expensive, time consuming and unsuccessful.”
In June 2024, we engaged JunHe LLP to conduct certain freedom-to-operate searches and
analyses (“ FTO Analysis ”) in China and the U.S. in relation to our Core Products, namely
DB-1303 and DB-1311. Our Directors confirm that no substantial risk of infringement had
been identified from the FTO Analysis in relation to the constructs, amino acid sequences,
chemical structures or indications currently under development of our Core Products.
BUSINESS
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SUPPLIERS AND PROCUREMENT
During the Track Record Period, our major suppliers primarily included (i) CROs and
CDMOs, (ii) licensing partners, and (iii) equipment and device suppliers and
renovation/construction service providers for our R&D facilities and offices. We have
maintained stable business relationships with our major suppliers. During the Track Record
Period, we did not experience any material disputes with our suppliers, difficulties in the
procurement of raw materials or services, disruptions to our operations due to a shortage of or
delay in supply of raw materials or services, or significant fluctuations in raw material and/or
service prices.
For the years ended December 31, 2023 and 2024, our purchases from our five largest
suppliers in each year in aggregate accounted for 42.0% and 67.1% of our total purchases for
the respective year, respectively. Our purchases from our largest supplier in each year
accounted for 12.5% and 25.7% of our total purchases for the respective year, respectively. The
following table summarizes information about our five largest suppliers and our purchases
from them during each year of the Track Record Period.
Ranking Supplier Background
Purchase
amount
%o f
total
purchase
Credit
Term
Commencement
of business
relationships
RMB’000 %
For the year ended
December 31, 2024
1 /H1118/H1118/H1118/H1118/H1118Supplier A A leading China-based
CRO with global
presence and a listed
company on the Stock
Exchange
453,987 25.7 10 or 30 days 2021
2 /H1118/H1118/H1118/H1118/H1118Supplier B A leading China-based
CRO with global
presence and a listed
company on the Stock
Exchange
291,454 16.5 60 days 2021
3 /H1118/H1118/H1118/H1118/H1118Supplier C A leading China-based
CRO with global
presence
180,256 10.2 21 or 60 days 2020
4 /H1118/H1118/H1118/H1118/H1118Supplier D A leading U.S.-based
CRO with global
presence and a listed
company on the New
Y ork Stock Exchange
139,864 7.9 45 days 2023
5 /H1118/H1118/H1118/H1118/H1118Supplier E A leading U.S.-based
CRO with global
presence
119,529 6.8 30 days 2022
Total /H1118/H1118/H1118 1,185,090 67.1
BUSINESS
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Ranking Supplier Background
Purchase
amount
%o f
total
purchase
Credit
Term
Commencement
of business
relationships
RMB’000 %
For the year ended
December 31, 2023
1 /H1118/H1118/H1118/H1118/H1118Supplier A A leading China-based
CRO with global
presence and a listed
company on the Stock
Exchange
139,499 12.5 10 or 30 days 2021
2 /H1118/H1118/H1118/H1118/H1118Supplier B A leading China-based
CRO with global
presence and a listed
company on the Stock
Exchange
129,463 11.6 60 days 2021
3 /H1118/H1118/H1118/H1118/H1118Supplier F A leading China-based
CRO with global
presence and a listed
company on the
Shanghai Stock
Exchange
74,798 6.7 30 days 2020
4 /H1118/H1118/H1118/H1118/H1118Supplier D A leading U.S.-based
CRO with global
presence and a listed
company on the New
Y ork Stock Exchange
71,685 6.4 45 days 2023
5 /H1118/H1118/H1118/H1118/H1118Supplier C A leading China-based
CRO with global
presence
53,643 4.8 21 or 60 days 2020
Total /H1118/H1118/H1118 469,088 42.0
To monitor the quality of supplies, we implement a standardized operating system, setting
out the procedures and guidelines for quality control inspection. This includes rigorous
supplier qualification and selection based on stringent quality standards, detailed material
specifications, and standards that outline required characteristics.
To the best knowledge of our Directors, none of our Directors, their respective associates
or any of our Shareholders holding more than 5% of our issued share capital immediately
following the completion of the Global Offering had an interest in any of our five largest
suppliers during the Track Record Period.
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CUSTOMERS
During the Track Record Period, our revenue was primarily derived from our license and
collaboration agreements with our business partners. For further details, please refer to
“Financial Information — Description of Selected Components of the Consolidated Statements
of Comprehensive Loss — Revenue.” For the years ended December 31, 2023 and 2024, our
revenue generated from our largest customer in each year accounted for 98.9% and 80.7% of
our total revenue for the respective year. The following table summarizes information about all
our largest customers and our revenue from them during each year of the Track Record Period.
Ranking Customer
Revenue
amount
% of total
revenue
Commencement
of business
relationships
Products/
services
purchased Background
RMB’000 %
For the year ended December 31, 2024
1 /H1118/H1118/H1118/H1118/H1118BioNTech 1,566,650 80.7 2023 ADC candidate
out-license
Biopharmaceutical
company
2 /H1118/H1118/H1118/H1118/H1118Customer A 331,596 17.1 2023 ADC candidate
out-license
A China-based
biopharmaceutical
company and a
listed company
on the Stock
Exchange
3 /H1118/H1118/H1118/H1118/H1118Customer B 42,900 2.2 2022 ADC candidate
out-license
A Europe-based
biopharmaceutical
company
4 /H1118/H1118/H1118/H1118/H1118Customer C 111 0.0 2024 Plasma stability
study
A Europe-based
biopharmaceutical
company
Total /H1118/H1118/H1118 1,941,257 100.0
Ranking Customer
Revenue
amount
% of total
revenue
Commencement
of business
relationships
Products/
services
purchased Background
RMB’000 %
For the year ended December 31, 2023
1 /H1118/H1118/H1118/H1118/H1118BioNTech 1,766,133 98.9 2023 ADC candidate
out-license
Biopharmaceutical
company
2 /H1118/H1118/H1118/H1118/H1118Customer B 19,897 1.1 2022 ADC technology
out-license
A Europe-based
biopharmaceutical
company
3 /H1118/H1118/H1118/H1118/H1118Customer D 283 0.0 2022 Pre-agreement
biological
materials
provision
A China-based
biopharmaceutical
company
4 /H1118/H1118/H1118/H1118/H1118Customer E 227 0.0 2022 Pre-agreement
biological
materials
provision
A Europe-based
biopharmaceutical
company
Total /H1118/H1118/H1118 1,786,540 100.0
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To the best knowledge of our Directors, none of our Directors, their respective associates
or any of our Shareholders holding more than 5% of our issued share capital immediately
following the completion of the Global Offering had an interest in any of our customers during
the Track Record Period.
COMPETITION
The ADC industry is competitive and subject to rapid and significant change. While we
believe the strength of our pipeline, technology platforms and R&D capability gives us
competitive advantages, we face potential competition from many industry players, including
MNCs and leading biotechnology companies, who have commercialized, or are pursuing the
development of, ADC drugs that are similar to ours or target the same indications. Any ADC
candidates that we successfully develop and commercialize will compete both with approved
drugs and with any new drugs that may become available in the future. For instance, our Core
Products, DB-1303 and DB-1311, and other pipeline products may face competition from
existing ADCs directed against the same molecular targets and approved for the same target
indications upon potential marketing approval in the future. As of the Latest Practicable Date,
there were five, nine and 15 HER2 ADCs targeting EC across HER2-expressing level,
HR+/HER2-low BC, and HER2+ BC, respectively, in phase 2 clinical development or beyond
globally, including our DB-1303. As of the same date, there were nine and six B7-H3 ADCs
targeting SCLC and CRPC, respectively, under clinical development globally, including our
DB-1311.
In addition to competition within the ADC industry, our pipeline products also face
competition from other treatment modalities, including oncology chemotherapy and
monoclonal antibody for oncology treatment such as PD-(L)1 checkpoint inhibitors. Some of
these modalities may have more established market recognition and we may face challenges in
competing with them. Our competitors may have substantially greater financial, technical, and
other resources than we do, such as those with larger research and development staff and
established marketing and manufacturing infrastructure. Collaborations, mergers and
acquisitions in the biopharmaceutical industry may result in even more resources being
concentrated in our competitors. As a result, these companies may be able to advance their drug
candidates and obtain regulatory approval from the regulatory authorities more rapidly than we
do, and become more effective in selling and marketing their products. For details of the risks
relating to the competition we may face, please see “Risk Factors — Risks Relating to the
Development of Our Drug Candidates — We face intense competition and rapid technological
change and the possibility that our competitors may develop therapies that are similar, more
advanced, or more effective than ours, which may adversely affect our financial condition and
our ability to successfully commercialize our drug candidates.” For further details on market
opportunities and competition in respect of our ADC candidates, see “— Our Pipeline” and
“Industry Overview.”
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To strengthen our long-term market position, we take a differentiated clinical
development strategy to accelerate the global expansion of our drug programs and maximize
their impact on patients worldwide. More specifically, we employ (i) a “first-to-market”
approach, where we prioritize initial target indications that are commercially attractive and
often underserved, which enable us to demonstrate key asset differentiation, and rapidly enter
and establish a strong presence in the global market, (ii) a complementary
“fast-to-commercial” approach to accelerate access to our differentiated assets for a wider
addressable population of patients in need, and (iii) combination therapy strategies to unlock
the frontline and backbone potential for our assets and offer improved clinical benefits to
patients. For details, see “— Our Business Strategies — Accelerating global development and
commercialization of clinical-stage assets.”
EMPLOYEES
As of December 31, 2024, we had 170 employees, a majority of whom were based in
China. The following table sets forth the number of our employees by function as of the same
date.
Function
Number of
Employees % of total
Research and development /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118131 77.1%
Administrative /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111817 10.0%
Management /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111812 7.1%
Manufacturing and quality control /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184 2.4%
Business development /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186 3.5%
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/H1118170 100.0%
The following table sets forth the number of our employees by location as of the same
date.
Location
Number of
Employees % of total
China /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118147 86.5%
U.S. /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 13.5%
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/H1118170 100.0%
We recruit our employees primarily through online platforms, recruiting websites and
headhunter referral. We conduct induction programs and periodic professional training for our
employees.
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We enter into individual employment contracts with our employees covering matters such
as salaries, bonuses, employee benefits, confidentiality obligations, non-competition clauses,
work product and intellectual property assignment clause and grounds for termination. The
remuneration package of our employees includes salary and bonus, which are generally
determined by their qualifications, performance review, and seniority. We also offer share
incentives and promotion opportunities to motivate our employees.
We have not established a labor union. During the Track Record Period and up to the
Latest Practicable Date, we did not experience any labor disputes or strikes that may have a
material and adverse effect on our business, financial condition or results of operations.
INSURANCE
We maintain insurance policies that are required under PRC laws and regulations as well
as based on our assessment of our operational needs and industry practice. Our existing
insurance policies cover adverse events (“ AEs”) in our clinical trials, as well as supplementary
commercial insurance plans for our employees. In line with industry practice in the PRC, we
have elected not to maintain certain types of insurances, such as business interruption
insurance or key man insurance. We believe our existing insurance coverage is adequate for our
present operations and in line with the industry practice in the PRC. See also “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.”
SOCIAL, HEALTH, WORK SAFETY AND ENVIRONMENTAL MATTERS
We believe our long-term success rests on our ability to make a positive impact on the
society. As we continue to bring innovative and effective ADC drugs to patients in China and
worldwide, we strive to build a sustainable ecosystem comprised of our employees,
collaborators and business partners, physicians, and patient groups.
We are subject to various health, work safety and environmental laws and regulations and
our operations are regularly inspected by local government authorities. During the Track
Record Period and up to the Latest Practicable Date, we had been in compliance with health,
work safety and environmental laws and regulations applicable to our operations in all material
respects and had not been subject to any material claims, fines or other penalties due to
non-compliance with health, work safety or environmental regulations that would materially
and adversely affect our business, financial condition or results of operations.
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Governance on ESG Matters
We have built a series of policies and procedures to contribute to social, health, work
safety and environmental matters. Going forward, it is our objective to proactively identify and
assess the actual and potential environmental, social and governance (“ ESG”) risks that may
impact our business, strategy and financial performance, and integrate considerations of ESG
issues into our business, strategic and financial planning, in compliance with the
recommendations made by the Environmental, Social and Governance Reporting Guide in
Appendix C2 to the Listing Rules.
We are committed to strengthening our ESG oversight mechanisms by thoroughly
integrating environmental, social, and governance factors into our business operations and
ensuring compliance with relevant environmental protection laws and regulations. Recognizing
the risks and opportunities associated with ESG, we are dedicated to identifying and addressing
these factors through environmental impact assessments and management. We are exploring
various measures to mitigate ESG-related risks while striving to balance cost-effectiveness
with sustainable development. Our emissions reduction targets are based on industry standards
and our specific circumstances, aiming to enhance our environmental performance in
alignment with best practices. We plan to set up a timeline for achieving our ESG goals through
a phased approach that ensures feasibility and traceability. Furthermore, we are committed to
fostering a culture of compliance, with a goal to ensure that all employees are well-informed
of and adhere to relevant ESG regulations and requirements through cross-departmental
collaboration.
Our Board is responsible for monitoring and enhancing compliance with ESG laws and
regulations. Our management regularly reports to the board on ESG matters, and the Board
makes decisions regarding our policies and practices in alignment with ESG requirements. The
Board will continue to monitor, evaluate, and address ESG issues, overseeing the
implementation of policies that promote ESG practices.
Environmental Protection
We strive to conduct our operations in a manner that safeguards the environment
associated with our operation.
Wastes
We have established waste management procedures to ensure compliance with relevant
waste disposal regulations and to minimize environmental impact. The waste is categorized
into hazardous waste (such as chemical waste and liquid waste) and non-hazardous waste (such
as waste from general office operations). The wastewater and solid waste generated during our
in-house research and development process are pre-treated by our team before being handled
by qualified third-party medical waste treatment companies. We have implemented a
comprehensive hazardous waste management system. This includes maintaining a hazardous
waste ledger, completing and executing transfer documentation, and contracting with qualified
institutions for hazardous waste disposal.
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Greenhouse gas emission
Our greenhouse gas emissions consist of Scope 1 and Scope 2 emissions. Scope 1 direct
emissions include the greenhouse gas emissions from our manufacturing facilities and other
stationary combustion sources. Scope 2 energy indirect emissions primarily include the
greenhouse gas emissions from our usage of purchased electricity. In response to the national
carbon neutrality target, we are committed to actively reducing the greenhouse gas emissions
produced in our operations.
Management of Environmental Protection Matters
We conduct environmental impact assessments to monitor emission levels. We use a range
of metrics to evaluate the impact of environmental risks. Furthermore, we have set multiple
objectives to reduce our environmental footprint and are actively pursuing significant measures
to meet these targets. The following table sets forth the indicators related to our energy
consumption and waste production during the Track Record Period.
For the year ended December 31,
2023 2024
Energy consumption
Electricity (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/H1118509.2 653.1
Water* (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/H1118293.1 1,019.3
Waste /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Hazardous waste* (tons) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180.6 2.0
* In our Suzhou laboratory.
As our business grows and our candidates move closer to commercialization, we
anticipate an increase in resource consumption and emissions. Nonetheless, we are dedicated
to implementing a variety of measures to optimize resource use and reduce emissions.
Simultaneously, we strive to cultivate a corporate culture that prioritizes environmental
protection and work closely with our business partners to establish an eco-friendly ecosystem.
Our commitment includes enhancing the environmental performance across our entire value
chain, which encompasses office operations, supplier selection, laboratory activities, and waste
management. We expect our energy consumption in 2024 to be approximately 200% of the
level recorded in 2023, in line with our business growth.
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Patient Data Protection and Prevention of Data Manipulation
We are committed to the protection of trial participant information in compliance with the
applicable laws, regulations and industry standards. We generally require CROs to keep all
documents, data, records, and information provided by us or generated during the contract
strictly confidential. The CROs are also required to ensure that their employees, consultants,
and other professionals who access this confidential information are bound by the same
confidentiality obligations. Without our prior written consent, CROs are generally prohibited
from disclosing, revealing, or disseminating any confidential information to third parties in any
form. Additionally, to the extent possible, we require CROs to implement protective measures
that are at least equivalent to those they use for their own confidential information, to prevent
unauthorized use, disclosure, or leakage of the information provided by us or generated during
the trial. Furthermore, our contracts with R&D employees contain confidentiality clauses,
adding an extra layer of security for the confidential information. Through these measures, we
maintain a high standard of confidentiality and data protection throughout the clinical trial
process.
We have established comprehensive internal policies to protect data integrity and prevent
data manipulation, specifically outlined in our Code of Business Conduct and Ethics, Data
Protection Policy regarding detection and response to data breaches, tampering, and data loss,
and the Compliance Disciplinary Policy. These policies establish clear guidelines for data
handling and set forth consequences for policy violations. Together, they form a robust
framework to safeguard the authenticity and reliability of our research and clinical data.
Manufacturing and Quality Management
We strive to align our manufacturing and quality management practices with ESG
standards. We prioritize partnerships with suppliers who demonstrate strong environmental
practices in their raw material sourcing and production processes. Meanwhile, we maintain a
comprehensive quality management system which is developed and continuously refined to
meet the stringent regulations and guidelines in China, the U.S., and Europe. We regularly
audit and inspect CDMOs to verify that their processes align with our quality requirements and
regulatory standards. See also “— Quality Management.” Through the integration of rigorous
quality standards and sustainable manufacturing practices, we strive to establish ourselves as
a responsible participant in the ADC industry.
Management of Third-Party Relationships
We maintain strict compliance standards in our third-party engagements through a robust
internal policy framework. Our procurement management system establishes clear protocols
for supplier interactions, with specific anti-bribery and anti-corruption provisions. For
healthcare professionals, we follow detailed guidelines that govern all professional
engagements. Our Code of Business Conduct and Ethics provides additional safeguards against
corruption, bribery, and unfair competition, while our third-party contracts incorporate specific
compliance requirements.
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Work Safety
We strive to provide a safe and healthy working environment for our employees. To
achieve this, we have established stringent safety protocols. These protocols are reinforced by
regular safety training initiatives that equip our employees with the necessary awareness and
technical expertise to perform their duties safely and efficiently. Our safety measures
encompass our operations as well as our primary operational sites. We have specific protocols
in place for managing emergency matters. Regular meetings and periodic inspections are
conducted to ensure continuous adherence to our safety standards. Through these efforts, we
maintain a secure and productive working environment that supports the well-being of our
employees and the success of our enterprise. During the Track Record Period and up to the
Latest Practicable Date, we did not have any major workplace accidents.
Workplace Diversity
We are dedicated to fostering an inclusive and open workplace that values equality. Our
recruitment practices are strictly merit-based, ensuring that all employees are provided with
equal opportunities regardless of gender, age, race, religion, or any other social or personal
attributes. As of December 31, 2024, over half of our total employees were female. We are
committed to maintaining a fair and transparent employee management system and
continuously strive to enhance the gender and age diversity of our workforce.
Animal Welfare
We typically engage CROs to conduct animal studies, and the CROs we engaged have
obtained certification from the Association for Assessment and Accreditation of Laboratory
Animal Care. This certification promotes compliance with key regulations regarding animal
welfare, including the humane treatment of all animals, the promotion of psychological
well-being, access to adequate veterinary care, ethical reviews of research protocols, proper
training for personnel involved in animal care, and ongoing compliance monitoring to uphold
high standards of animal welfare throughout the research process.
PROPERTIES
We have presence in Shanghai, Suzhou and Beijing in China, as well as in the U.S. We
currently lease all of the properties used in our operations from Independent Third Parties. As
of the Latest Practicable Date, we had nine property leases in Shanghai, Jiangsu Province, and
Beijing for R&D and office use, with an aggregate GFA of approximately 5,039 m
2. Our
employees based in the U.S., primarily including our overseas R&D, translational medicine
and clinical operation personnel, work remotely from New Jersey and California.
Pursuant to the applicable PRC laws and regulations, property lease agreements must be
registered with the local branch of the Ministry of Housing and Urban-Rural Development of
the PRC. As of the Latest Practicable Date, our lease agreements in China had not been
registered. Our PRC Legal Advisor are of the view that the non-registration of our lease
agreements will not affect the validity of such lease agreements, but the relevant local housing
administrative authorities may require us to complete registrations within a specified
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timeframe and we may be subject to a fine between RMB1,000 and RMB10,000 per lease for
any delay in making these registrations. Therefore, we have the right to use such properties in
accordance with the lease agreements, but we may be subject to the risks of fines if lease
registration is not completed as required by the relevant local housing administrative
authorities. During the Track Record Period and up to the Latest Practicable Date, we were not
subject to any penalties arising from the non-registration of the lease agreements. See “Risk
Factors — Risks Relating to Our Operations — Our leased properties may be subject to
non-compliances or challenges that could potentially affect our future use of them” for details.
A W ARDS AND RECOGNITION
The table below sets forth a summary of the major awards and recognition we received
during the Track Record Period.
Awards or Recognitions Y ear Granted Granting Authority
Best New Drug Developer /H1118/H1118/H1118/H1118/H1118/H11182024 11th Annual World ADC Awards
Suzhou City 2022 “Unicorn”
Cultivation Enterprise (2022 ϋ
ᘽψ̹ዹԉᖕ੃ԃΆุ) /H1118/H1118/H1118
2023 Suzhou Municipal People’s
Government (ִ݁)
Jiangsu Province 2022 “Potential
Unicorn” Enterprise (2022 ϋϪ
ᆑίዹԉᖕΆุ) /H1118/H1118/H1118/H1118/H1118
2022 Productivity Center of Jiangsu
Province (ආʕ
ː)
LICENSES, PERMITS AND APPROV ALS
Our PRC Legal Advisor has advised us that, during the Track Record Period and up to the
Latest Practicable Date, we had obtained all requisite licenses, approvals and permits from the
relevant government authorities that are material for our business operations in the PRC.
LEGAL PROCEEDINGS AND COMPLIANCE
We may from time to time be subject to legal or administrative claims and proceedings
arising from the ordinary course of business. In particular, despite measures we take to obtain
and maintain patent and other intellectual property rights with respect to our drug candidates,
our intellectual property rights could be challenged or invalidated. During the Track Record
Period and up to the date of this prospectus, except as disclosed below, we have not been a
party to any actual or threatened legal or administrative proceedings which may have a material
adverse effect on our business, financial condition and results of operations, and our Directors
have not been involved in any such proceedings.
We are committed to maintaining the highest standards of compliance with the laws and
regulations applicable to our business. During the Track Record Period and up to the date of
this prospectus, we have complied in all material respects with the applicable laws and
regulations relating to our business operations.
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Legal Proceedings Regarding Certain Patent Applications
We are currently involved in three legal proceedings in China where a third party
(“Plaintiff ”) has filed claims against both our Company and one of our employees (the
“Employee ”), alleging ownership rights over certain of our patent applications. Some of these
patent applications are related to parts of some molecular structures derived from our
proprietary technology platforms and used in certain of our ADC candidates, including
clinical-stage assets (such as our Core Products) (“ Relevant Patents ”). These cases are still
ongoing as of the date of this prospectus. We have engaged external IP litigation counsel and
are vigorously advocating for our patent rights in these proceedings. For more details on the
patent rights related to our technology platforms and ADC assets, see “— Intellectual
Property.”
As advised by our IP litigation counsel, we believe the Plaintiff’s claims are without merit
and unlikely to succeed, primarily because (i) the Relevant Patents are the results of inventions
and R&D work conducted independently by us prior to the Employee’s arrival, while the
Plaintiff fails to provide substantive evidence supporting its claims to the contrary, and (ii) the
Relevant Patents contain molecular structures that are substantially different from those cited
in the evidence presented by the Plaintiff. Based on a thorough assessment of the claims and
the information currently available, our Directors are of the view that these legal proceedings
are not expected to have a material impact on our R&D activities, clinical development plans,
external collaborations, business operations or financial performance.
While we believe the Plaintiff’s claims are without merit and will continue to vigorously
advocate for our rights in these proceeds, litigation outcomes are inherently uncertain, although
we do not expect potential limitations that may be imposed to materially impair our ability to
advance the R&D and clinical development of our ADC candidates, considering, among other
factors, the applicable patent laws preserving a patent owner’s right to independently
implement their patented technologies. See also “Risk Factors — Risks Relating to Intellectual
Property Rights — We may from time to time be involved in legal proceedings and disputes
to protect or enforce our intellectual property rights, or defend against infringement and other
claims alleged by third parties, which could be expensive, time consuming and unsuccessful.”
RISK MANAGEMENT AND INTERNAL CONTROL
We have established and maintained risk management and internal control systems
consisting of policies and procedures that we consider to be appropriate for our business
operations.
Risk Management
We recognize that effective risk management is critical to the success of our business
operations. The key operational risks we face include, among others, changes in the general
market conditions and regulatory environment of the PRC and global biopharmaceutical
markets, our ability to develop, manufacture, and commercialize our drug candidates, as well
as our ability to compete with other biopharmaceutical companies. See “Risk Factors” for
detailed discussion of the various risks and uncertainties we confront. We also encounter
diverse market risks, including credit, liquidity, interest rate, and currency risks. See “Financial
Information — Quantitative and Qualitative Disclosure about Market Risk”.
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To address these challenges, we have implemented a comprehensive set of risk
management policies that establish a framework to identify, assess, evaluate, and continuously
monitor the key risks associated with our strategic objectives. Risks identified by our
management are analyzed based on likelihood and impact, and are then properly followed up,
mitigated, and rectified by our Group, meanwhile reporting to our Board of Directors. Our
Directors oversee the implementation of these risk management policies.
To monitor the ongoing implementation of 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:
 Our Directors will oversee and manage the overall risks associated with our business
operations by (i) reviewing and approving our risk management policy to ensure
alignment with our corporate objectives; (ii) reviewing and approving the annual
working plan and annual report on corporate risk management; (iii) monitoring the
most significant risks related to our business operations and evaluating our
management’s handling of these risks; (iv) assessing our corporate risk in relation
to our risk tolerance; and (v) ascertaining the appropriate application of our risk
management framework across our Group.
 Our finance, legal, human resources and other relevant departments will be
responsible for (i) developing our risk management policy and reviewing major risk
management issues within our Company; (ii) creating the annual risk management
plan and report; (iii) offering guidance on our risk management approach to relevant
departments and supervising the implementation of our risk management policy; (iv)
reviewing reports on key risks from relevant departments and providing feedback;
and (v) conducting education and training related to risk management.
 Our finance, legal, human resources and other relevant departments will be
responsible for implementing our risk management policy and conducting daily risk
management activities. To standardize risk management across our Group and
establish a common level of transparency and performance, these departments will
(i) gather information about risks related to their operations or functions; (ii)
conduct risk assessments, which include identifying, prioritizing, measuring, and
categorizing all key risks that could potentially impact their objectives; (iii)
continuously monitor key risks related to their operations or functions; (iv)
implement appropriate risk responses as needed; (v) develop and maintain
mechanisms to facilitate the application of our risk management framework; and (vi)
promptly report any material risks to relevant departments.
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Internal Control
Our Board is responsible for establishing our internal control system and reviewing its
effectiveness. We have engaged an independent internal control consultant (the “ Internal
Control Consultant ”) to perform certain agreed-upon procedures (the “ Internal Control
Review ”), in connection with the internal control of our Company and our major operating
subsidiaries and to report factual findings on our Group’s entity-level controls and internal
controls of various processes, including financial reporting and disclosure controls, human
resources and payroll management, general controls of IT system, taxation management,
procurement management, and other procedures of our operations. The Internal Control
Consultant performed the Internal Control Review in June 2024 and follow-up reviews in July
2024. As of the Latest Practicable Date, there were no material outstanding issues relating to
our Group’s internal control.
During the Track Record Period, we regularly reviewed and enhanced our internal control
system. Below is a summary of the internal control policies, measures and procedures we have
implemented or plan to implement:
 We have implemented a range of measures and procedures covering various aspects
of our business operations, including related party transactions, risk management,
intellectual property protection, environmental protection, and occupational health
and safety. For more information, see “— Intellectual Property” and “— Social,
Health, Work Safety and Environmental Matters.” As part of our employee training
program, we regularly provide training on these measures and procedures to our
staff.
 Our Directors, who are responsible for overseeing the corporate governance of our
Group, will, with assistance from our legal advisers, will periodically review our
compliance status with all relevant laws and regulations following the Listing.
 We have established an audit committee which (i) makes recommendations to our
Directors on the appointment and removal of external auditors; and (ii) reviews the
financial statements and renders advice in respect of financial reporting as well as
oversees internal control procedures of our Group.
 We have engaged First Shanghai Capital Limited as our compliance adviser to
provide advice to our Directors and management team until the end of the first fiscal
year after the Listing regarding matters relating to the Listing Rules. Our
compliance adviser is expected to ensure our use of funding complies with the
section headed “Future Plans and Use of Proceeds” in this prospectus after the
Listing, as well as to provide support and advice regarding requirements of relevant
regulatory authorities in a timely fashion.
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Y ou should read the following discussion and analysis in conjunction with our
consolidated financial information, including the notes thereto, included in the
Accountant’s Report set out in Appendix I to this prospectus. Our consolidated
financial information has been prepared in accordance with International Financial
Reporting Standards (“IFRSs ”).
The following discussion and analysis contain forward-looking statements that
reflect our current views with respect to future events and financial performance that
involve risks and uncertainties. These statements are based on assumptions and
analysis made by us in light of our experience and perception of historical events,
current conditions and expected future developments, as well as other factors we
believe are appropriate under the circumstances. Our actual results may differ
materially from those anticipated in these forward-looking statements as a result of
certain factors. We discuss factors that we believe could cause or contribute to these
differences below and elsewhere in this prospectus, including those set forth in “Risk
Factors” and “Forward-Looking Statements” in this prospectus.
OVERVIEW
We are a key player in the global ADC landscape, dedicated to the development of
innovative therapeutics in this fast-growing drug modality to treat cancer, autoimmune
diseases, and beyond. Our pipeline comprises 12 in-house discovered assets, with seven in the
clinical stage and five in the preclinical stage. All of our clinical-stage assets had obtained IND
approvals from both the FDA and the NMPA as of the Latest Practicable Date. We have seven
ongoing global MRCTs across 17 countries and over 230 trial sites, with over 2,000 patients
(more than 50% located in the U.S., EU, Australia and other regions outside China) enrolled
as of the Latest Practicable Date, including four conducted in collaboration with our strategic
partners for which we are currently acting as the trial sponsor. In our short operating history,
we have entered into several out-licensing and collaboration deals with leading industry
players worldwide to date, including BioNTech (for DB-1303/BNT323, DB-1311/BNT324 and
DB-1305/BNT325), BeiGene (for DB-1312), Adcendo (for ADC assets using our proprietary
payload linkers), GSK (for DB-1324), and Avenzo (for DB-1418/A VZO-1418), with over
US$6.0 billion in total deal value (of which approximately US$500 million had been received
as of the Latest Practicable Date).
We currently have no products approved for commercial sales and was loss-making
during the Track Record Period. We incurred losses of RMB357.5 million and RMB1,050.4
million for the years ended December 31, 2023 and 2024 respectively, which were primarily
resulted from expenses in relation to R&D activities as well as fair value change of financial
liabilities at fair value through profit or loss in relation to our Preferred Shares. For the years
ended December 31, 2023 and 2024, we recognized revenue of RMB1,786.5 million and
RMB1,941.3 million, respectively, substantially all of which were derived from our out-license
and collaboration agreements.
FINANCIAL INFORMATION
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We expect to incur significant expenses for at least the next several years as we continue
to advance our preclinical research and clinical development plans, and to prepare for the
commercialization of our drug candidates. Subsequent to the Listing, our financial performance
may fluctuate from period to period due to, among other factors, the development status of our
drug candidates, regulatory approval timeline, and commercialization of our drug candidates
after approval.
BASIS OF PREPARATION
Our historical financial information has been prepared in accordance with all applicable
International Financial Reporting Standards issued by the International Accounting Standards
Board (“ IFRS Accounting Standards ”). Our historical financial information has been
prepared under the historical cost convention, except for financial assets and financial
liabilities measured at fair value through profit or loss. The preparation of historical financial
information in conformity with IFRS Accounting Standards requires the use of certain critical
accounting estimates. It also requires our management to exercise judgement in the process of
applying our accounting policies. The areas involving a higher degree of judgement or
complexity, or areas where assumptions and estimates are significant to our historical financial
information are disclosed in note 4 to the Accountant’s Report set out in Appendix I to this
prospectus. All effective standards, amendments to standards and interpretations, which are
mandatorily effective for the financial year beginning on January 1, 2024, are consistently
applied to us for the Track Record Period.
We had net current liabilities of RMB1,961.7 million as of December 31, 2024, of which
the convertible preferred shares classified as current liabilities were RMB3,046.8 million and
contract liabilities were RMB90.3 million, which do not result in future cash payments. We had
net liabilities of RMB2,021.9 million as at December 31, 2024, of which the convertible
preferred shares classified as liabilities were RMB3,046.8 million and contract liabilities were
RMB328.5 million, which do not result in future cash payments. Our Directors assessed our
Group’s liquidity by evaluating our ability to generate cash from operating activities, attract
additional capital or other means of finance funding. Historically, we have relied principally
on both operational sources of cash (e.g., revenue from out-licensing) and non-operational
sources of financing from investors (e.g., convertible preferred shares) to fund our research and
development activities.
Pursuant to the resolution passed by the Shareholders in September 2022, we shall
redeem, at the option of any holder of outstanding convertible preferred shares, all of the
outstanding convertible preferred shares held by the requesting holder, at any time after the
earliest occurrence of failure to complete the qualified public offering within four years after
April 23, 2021. In August 2024, we entered into supplemental agreements with respect to
certain rights with the shareholders to suspend such redemption feature for a period
commencing on the day immediately prior to the date of our first submission of the Listing
application, until the earlier of: (a) the withdrawal of the Listing application by us; (b) the
rejection of the Listing application; and (c) the expiration of 18 months after the first
submission date.
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Based on the above factors and our Group’s historical performance and our management’s
operating and financing plans, our Directors believe the cash and cash equivalents and the
operating and financing cash flows are sufficient to meet the cash requirements to fund our
Group’s planned operations, capital expenditures and other obligations for at least the next 12
months after December 31, 2024. Therefore, our historical financial information have been
prepared on a going concern basis, which contemplates the realization of assets and settlement
of liabilities in the normal course of business.
KEY FACTORS AFFECTING OUR RESULTS OF OPERATIONS
We believe that the most significant factors affecting our results of operations and
financial condition include the following:
Our Ability to Successfully Develop and Commercialize Our Drug Candidates
The success of our business and results of operation relies on our ability to advance our
drug development programs, demonstrate satisfactory safety and efficacy in clinical trials,
obtain the necessary regulatory approvals, and launch our products in our target markets as
planned. All of our ADC candidates are currently in the development stage. To date, we have
built a pipeline comprising 12 in-house discovered assets, with seven in the clinical stage and
five in the preclinical stage. See “Business — Our Pipeline” for more details.
Based on the expected approval timeline of each late-stage ADC candidate in our
pipeline, which is subject to regulatory communications and marketing approval, we anticipate
filing for accelerated approval with the FDA as early as 2025 for DB-1303 as a treatment for
HER2-expressing EC. After our ADC candidates are commercialized, our business and results
of operations will depend on the market acceptance and sales of our commercialized drugs. See
also “Risk Factors — Risks Relating to the Development of Our Drug Candidates — We
depend substantially on the success of our drug candidates. If we are unable to successfully
complete clinical development, obtain regulatory approvals or achieve commercialization for
our drug candidates, or if we experience significant delays or cost overruns in doing any of the
foregoing, our business and prospects could be materially and adversely affected” for details.
Our Existing and Future License and Collaboration Arrangements
During the Track Record Period, we entered into a number of out-license and
collaboration agreements for our ADC assets and technology, and generated revenue in relation
to these agreements of RMB1,781.1 million and RMB1,937.0 million in 2023 and 2024,
respectively. 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. Upon commercialization, we will also be eligible to receive royalties on net sales
of the products. These strategic collaborations allow us to maximize the global value of our
assets and provide capital support for our other pipeline assets and sustainable long-term
growth. In addition to these out-license and collaboration agreements, we are also required to
pay certain milestone and royalty payments in relation to our in-licensing agreements based on
terms of the agreements. See “Business — Our Collaboration and Licensing Arrangements” for
details.
FINANCIAL INFORMATION
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The timing and amounts of milestone payments and royalties differ by agreement and
depend on the achievement of various milestones. Moreover, following the success of our
existing out-license and collaboration partnerships, we may enter into new partnerships and
collaborations depending on our development strategies. These factors will influence, and may
result in fluctuations in, our revenue, profit and results of operations from period to period.
Our Cost Structure
Our cost structure during the Track Record Period primarily consisted of costs and
expenses in relation to R&D activities and administrative expenses.
Our costs and expenses in relation to R&D activities, which represented our cost of
revenue and research and development expenses, were the largest component of our cost
structure during the Track Record Period. In 2023 and 2024, our costs and expenses in relation
to R&D activities were RMB986.7 million and RMB1,993.3 million, respectively. Our costs
and expenses in relation to R&D activities increased during the Track Record Period as we
rapidly advanced multiple ADC programs in or towards the clinic, including our initiation of
various clinical trials. Going forward, we expect to continue to incur significant R&D costs and
expenses as we advance our ADC candidates towards commercialization or clinical stage.
In 2023 and 2024, costs and expenses in relation to R&D activities incurred for our Core
Products were RMB635.3 million and RMB1,275.3 million, respectively, accounting for 64.4%
and 64.0% of our total costs and expenses in relation to R&D activities for the corresponding
periods. In 2023 and 2024, our research and development expenses accounted for 89.9% and
84.1% of our total operating expenses (which equals the sum of research and development
expenses and administrative expenses), respectively. The decrease in the percentage of
research and development expenses relative to total operating expenses in 2024 was primarily
due to increase in administrative expenses caused by share incentive expenses and listing
expenses.
Our administrative expenses, which primarily consisted of professional services expenses
and staff costs, amounted to RMB62.6 million and RMB158.7 million in 2023 and 2024,
respectively. Our administrative expenses increased during the Track Record Period primarily
because (i) our business grew and team expanded, (ii) our share incentive expenses increased,
and (iii) we engaged professional services in relation to our out-license and collaboration
agreements, equity financing and listing.
Going forward, our cost structure will evolve as we further develop our ADC candidates.
As our ADC candidates progress through preclinical studies and clinical trials and advance
towards commercialization, we expect to incur additional expenses related to research and
development, sales and marketing, and regulatory affairs, among other activities. Additionally,
we may also incur increased legal, compliance, accounting, insurance, and investor and public
relations expenses associated with being a public company in Hong Kong.
FINANCIAL INFORMATION
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Funding for Our Operations
During the Track Record Period, we funded our operations primarily through equity
financing and income from out-license and collaboration agreements. We expect to fund our
future operations primarily with existing cash, income from our out-license and collaboration
agreements, and net proceeds from the Global Offering. Upon the successful
commercialization of one or more of our ADC candidates, we expect to fund our operations in
part with income generated from sales of our commercialized drug products. As our business
continues to expand, we may require further funding through equity offerings, debt financing,
out-license and collaboration arrangements, and other sources. Changes in our ability to fund
our operations may affect our cash flow and results of operations. See also “Risk Factors —
Risks Relating to Our Financial Position and Need for Additional Capital — 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.”
MATERIAL ACCOUNTING POLICIES AND SIGNIFICANT ACCOUNTING
JUDGMENTS AND ESTIMATES
The preparation of our historical financial information requires our management to make
judgments, estimates and assumptions that affect the reported amounts of revenues, expenses,
assets and liabilities, and their accompanying disclosures, and the disclosure of contingent
liabilities. Such judgments, estimates and assumptions are continually evaluated and are based
on historical experience and various other factors, including expectations of future events, that
are believed to be reasonable under the circumstances, from which our actual results may
differ.
Set out below are material accounting policies, judgements and estimates which we
believe are most important for understanding our results of operations and financial condition.
See note 4 and other notes to the relevant financial line items or transactions to the
Accountant’s Report set out in Appendix I to this prospectus for a detailed description of our
material accounting policies, judgments and estimates.
Revenue Recognition
Revenue from contracts with customers is recognized when control of goods or services
is transferred to the customers at an amount that reflects the consideration to which we expect
to be entitled in exchange for those goods or services.
At contract inception, we assess the goods or services promised within each contract and
determines those that are performance obligations and assesses whether each promised good or
service is distinct.
FINANCIAL INFORMATION
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We consider the terms of the contracts to determine the transaction price. When the
consideration in a contract includes a variable amount, the amount of consideration is
estimated to which we 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.
We recognize revenue only when it satisfies a performance obligation by transferring
control of the promised goods or services. The transfer of control can occur over time or at a
point in time. A performance obligation is satisfied over time if it meets one of the following
criteria.
 The counterparty simultaneously receives and consumes the benefits provided by
our performance as we perform.
 Our performance creates or enhances an asset that the counterparty controls as the
asset is created or enhanced.
 Our performance does not create an asset with an alternative use to us and we have
an enforceable right to payment for performance completed to date.
If control of the goods and services transfers over time, revenue is recognized over the
period of the contract by reference to the progress towards complete satisfaction of that
performance obligation. We adopt an appropriate method of measuring progress for the purpose
of recognizing revenue. We evaluate the measure of progress at the end of each reporting
period and, if necessary, adjusts the measure of performance and related revenue recognition.
We enter into out-license and collaboration agreements for research, development,
manufacturing and commercialization services. The terms of these arrangements typically
include non-refundable upfront payments, reimbursements for costs incurred, milestone
payments and royalties on net sales of licensed products. The contracts generally do not include
a significant financing component.
As part of the accounting for these arrangements, we use the following significant
judgements:
 Licenses of intellectual property. We assess whether the licensing of our intellectual
property is distinct from the other performance obligations identified in the
arrangements. For licenses determined to be distinct, we recognize revenue from
non-refundable, upfront payments allocated to the license at a point in time, when
the license is transferred to the licensee and the licensee is able to use and benefit
from the license.
FINANCIAL INFORMATION
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 Research and development services. For research and development services
determined to be distinct, the portion of the reimbursements for costs incurred and
other transaction price allocated to the performance obligations is recognized as
revenue over time as delivery or performance of such services occurs.
 Milestone payments. At the inception of each arrangement that includes milestone
payments, we assess whether the milestones are considered highly probable of being
achieved and estimates the amount to be included in the transaction price using the
most likely amount method. In making these assessments, we consider various
factors such as the scientific, clinical, regulatory, commercial, and other risks that
must be overcome to achieve a particular milestone. Milestone payments that are
subject to regulatory approvals and commercialization stages are not considered
highly probable of being achieved until those approvals are received or
commercialization stages are achieved. The transaction price will be allocated to
each performance obligation on a relative stand-alone selling price basis, for which
we recognize revenue as or when the performance obligations are satisfied. At the
end of each subsequent reporting period, we re-evaluate the probability of
achievement of all milestones subject to constraint and, if necessary, adjusts our
estimate of the overall transaction price.
 Royalties. For arrangements that include sales-based royalties, we recognize
revenue at the later of (i) when the related sales occur, or (ii) when the performance
obligation to which some or all of the royalty has been allocated has been satisfied
(or partially satisfied).
The excess of cumulative revenue recognized in profit or loss over the cumulative billings
to customers is recognized as contract assets. The excess of cumulative billings to customers
over the cumulative revenue recognized in profit or loss is recognized as contract liabilities.
Intangible Assets
Software
Computer software is recognized at historical cost and subsequently carried at cost less
accumulated amortization and accumulated impairment losses. We amortized on a straight-line
basis over their estimated useful lives of one to three years.
In-licenses
Certain intangible assets are for in-licenses of intellectual properties in development, with
non-refundable upfront payment, milestone payment and royalty payment. Upfront payment is
capitalized when paid. The milestone payment is capitalized as intangible assets when incurred,
unless the payment is for outsourced research and development work which would follow the
capitalization policy in note 16(c) to the Accountant’s Report set out in Appendix I to this
prospectus. Royalty payment would be accrued for in line with the underlying sales and
recognized as a cost of revenue. However, if the intangible asset is acquired in a business
combination, it is measured at fair value at initial recognition.
FINANCIAL INFORMATION
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In-licenses with finite useful life are amortized using the straight-line basis over the
commercial lives of the underlying products, commencing from the date when the products are
put into commercial production.
Intangible assets not ready for use are not subject to amortization and are tested annually
for impairment, or more frequently if events or changes in circumstances indicate that they
might be impaired. We obtained in-licenses and in-process research and development to
continue research and development work and commercialize the products, which are classified
as intangible assets not ready for use.
An impairment loss is recognized for the amount by which the asset’s carrying amount
exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value
less costs of disposal and value in use. For the purposes of assessing impairment, assets are
grouped at the lowest levels for which there are separately identifiable cash flows (cash-
generating units).
Research and Development
We incur significant costs and efforts on research and development activities. Research
expenditures are charged to the profit or loss as an expense in the period the expenditures are
incurred. Development costs are recognized as assets if they can be directly attributable to a
newly developed drug products and all the following can be demonstrated:
(i) the technical feasibility of completing the intangible assets so that it will be
available for use or sale;
(ii) the intention to complete the intangible asset and use or sell it;
(iii) the ability to use or sell the intangible assets;
(iv) the intangible asset will generate probable future economic benefits;
(v) the availability of adequate technical, financial and other resources to complete the
development and to use or sell the intangible asset; and
(vi) the ability to measure reliably the expenditure attributable to the intangible asset
during its development.
All of our research expenditures during the Track Record Period were charged to the
profit or loss.
Research and development expenses include costs paid to hospitals and third-party CROs.
The estimate of accrual of research and development expenses is complex because billing terms
under relevant contracts often do not coincide with the timing of when the work is performed,
which in turn requires estimates of outstanding obligations as of the end of each year of the
Track Record Period. These estimates are based on a number of factors, including
management’s knowledge of the R&D programs and activities associated with timelines,
invoicing date, and the provisions in the contracts.
FINANCIAL INFORMATION
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Financial Liabilities at Fair Value Through Profit or Loss
Preferred Shares issued by us are redeemable upon occurrence of certain future events.
This instrument can be converted into Ordinary Shares at any time at the option of the holders
or automatically converted into Ordinary Shares upon occurrence of an initial public offering
of the Company.
We designated the Preferred Shares as financial liabilities at fair value through profit or
loss. They are initially recognized at fair value. Subsequent to initial recognition, the Preferred
Shares are carried at fair value with changes in fair value recognized in the consolidated
statements of comprehensive loss. If our own credit risk results in fair value changes in
financial liabilities designated as at fair value through profit or loss, they are recognized in
other comprehensive loss.
The fair value of Preferred Shares that are not traded in an active market is determined
by using valuation techniques. We applied back-solve method and the discounted cash flow
approach to determine the underlying equity value of the Company and adopted option-pricing
method and equity allocation model to determine the fair value of the Preferred Shares. Key
assumptions such as discount rate, volatility and discount for lack of marketability are
disclosed in note 25 to the Accountant’s Report set out in Appendix I to this prospectus.
Effective from January 1, 2024, “IAS 1 (Amendment) ‘Classification of Liabilities as
current or non-current’” requires a reclassification of convertible preferred shares from
non-current liabilities to current liabilities, as the convertible preferred shares may be
converted into ordinary shares at the option of the preferred shareholders at any time and the
conversion feature does not meet “fixed-for-fixed” criteria. Such accounting policy change has
been consistently applied to all the years presented in our historical financial information. This
classification is applicable to us because we do not have an unconditional right to defer the
settlement of these Preferred Shares for at least 12 months after the end of the Track Record
Period.
Share-based Compensation
We operate stock options granted to employees, under which we receive services from
employees as consideration for equity instruments of us. The fair value of the employee
services received in exchange for the grant of equity instruments (options) is recognized as an
expense in the historical financial information. The total amount to be expensed is determined
by reference to the fair value of the equity instruments granted:
 including any market performance conditions;
 excluding the impact of any service and non-market performance vesting conditions
(for example, the requirement for employees to serve);
 including the impact of any non-vesting conditions.
FINANCIAL INFORMATION
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--- page 456 ---
At the end of each year of the Track Record Period, we revise the estimates of the number
of options that are expected to vest based on the non-market vesting performance and service
conditions. We recognize the impact of the revision to original estimates, if any, in the
consolidated statements of comprehensive loss, with a corresponding adjustment to equity.
We have engaged an independent valuer to determine the fair value of the options granted
to employees, which is expensed over the vesting periods. Unobservable inputs, such as the
risk-free interest rate, volatility and dividend yield, are used in determining the fair value of
the share-based compensations.
For details, see note 13 to the Accountant’s Report set out in Appendix I to this
prospectus.
DESCRIPTION OF SELECTED COMPONENTS OF THE CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
The following table sets forth a summary of our consolidated statements of
comprehensive loss for the periods indicated. Our historical results presented below are not
necessarily indicative of the results that may be expected for any future period.
For the year ended December 31,
2023 2024
(RMB’000) (RMB’000)
Revenue /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,786,540 1,941,257
Cost of revenue /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(427,655) (1,156,590)
Gross profit /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,358,885 784,667
Research and development expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(558,997) (836,726)
Administrative expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(62,567) (158,692)
Other 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/H11183,261 7,338
Other gains, net /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111840,773 14,421
Operating profit/(loss) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118781,355 (188,992)
Finance 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/H111834,483 48,112
Finance costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(188) (250)
Fair value change of financial liabilities at fair
value through profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,017,899) (873,416)
Loss before income tax /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(202,249) (1,014,546)
Income tax expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(155,263) (35,888)
Loss for the year attributable to the owners of
the Company /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(357,512) (1,050,434)
FINANCIAL INFORMATION
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For the year ended December 31,
2023 2024
(RMB’000) (RMB’000)
Other comprehensive loss:
Items that will not be reclassified to profit or loss
Exchange differences on translation (1) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(19,553) (37,950)
Changes in fair value of financial liabilities
from own credit risk /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,688) (15)
Other comprehensive loss for the year,
net of tax /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(21,241) (37,965)
Total comprehensive loss for the year
attributable to the owners of the Company /H1118/H1118 (378,753) (1,088,399)
Note:
(1) The exchange differences on translation are primarily attributable to the discrepancy between the
presentation currency of our historical financial information (RMB) and the functional currency of
certain of our subsidiaries, including the Company, DualityBio HK Limited, and DualityBio Inc. (US
dollar). As DualityBio HK Limited, and DualityBio Inc. share the same functional currency as the
Company, they are not considered foreign operations. Consequently, we view the cumulative translation
adjustment as part of other comprehensive income items, which will not be reclassified to profit or loss.
Revenue
During the Track Record Period, our revenue was primarily derived from our out-license
and collaboration agreements, including income in relation to upfront payments, milestone
payments, and reimbursement for R&D activities we undertake for our out-licensed candidates.
See “Business — Our Collaboration and Licensing Arrangements” for details. The following
table sets forth a breakdown of our revenue in absolute amounts and as percentages of the total
revenue for the periods indicated.
For the year ended December 31,
2023 2024
(RMB’000) % (RMB’000) %
Revenue from the license and
collaboration agreement /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,781,088 99.7 1,937,049 99.8
– Upfront /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,437,267 80.5 348,869 18.0
– Milestone /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 377,760 19.5
– Reimbursement /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118343,821 19.2 1,210,420 62.3
Others (1) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,452 0.3 4,208 0.2
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/H11181,786,540 100.0 1,941,257 100.0
FINANCIAL INFORMATION
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The following table sets forth a breakdown of our revenue by drug candidates in absolute
amounts and as percentages of the total revenue for the periods indicated.
For the year ended December 31,
2023 2024
(RMB’000) % (RMB’000) %
Revenue from the license and
collaboration agreement /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,781,088 99.7 1,937,049 99.8
– DB-1303 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118699,567 39.2 817,376 42.1
– DB-1311 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118727,538 40.7 462,219 23.8
– DB-1305 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118339,027 19.0 287,055 14.8
– DB-1312 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 331,596 17.1
– DITAC platform /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814,956 0.8 38,803 2.0
Others (1) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,452 0.3 4,208 0.2
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/H11181,786,540 100.0 1,941,257 100.0
Note:
(1) Primarily including the consideration paid by our business partners in exchange for biological materials
to evaluate drug candidates in relation to the licensing deal.
Cost of Revenue
During the Track Record Period, our cost of revenue was primarily related to the R&D
activities we conducted in accordance with our out-license and collaboration agreements. The
costs were either incurred by us internally, or by third parties to whom we were obligated to
make payments. In 2023 and 2024, our cost of revenue was RMB427.7 million and
RMB1,156.6 million, respectively.
Gross Profit and Gross Profit Margin
In 2023 and 2024, our gross profit was RMB1,358.9 million and RMB784.7 million,
respectively. For the same periods, our gross profit margin was 76.1% and 40.4%, respectively.
Research and Development Expenses
During the Track Record Period, our research and development expenses primarily
consisted of (i) technical service expenses, primarily representing CRO and CDMO service
fees, (ii) staff costs, including wages, bonus, social insurance and other welfare, as well as
share incentive expenses in relation to Pre-IPO Equity Incentive Plan for our R&D personnel,
see “Statutory and General Information — D. Share Incentive Plan — Pre-IPO Equity
Incentive Plan” for details, (iii) depreciation of property, plant and equipment and right-of-use
assets, (iv) asset impairment loss, representing impairment provision in relation to an
FINANCIAL INFORMATION
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--- page 459 ---
in-licensed antibody, see “— Description of Selected Items from the Consolidated Balance
Sheets — Intangible Assets” for details, and (v) others, including expenses for warehouse,
logistics, insurance and miscellaneous items. The following table sets forth a breakdown of our
research and development expenses in absolute amounts and as percentages of the total
research and development expenses for the periods indicated.
For the year ended December 31,
2023 2024
(RMB’000) % (RMB’000) %
Technical service expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118494,404 88.4 598,112 71.5
Staff costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111858,545 10.5 203,422 24.3
Depreciation of property, plant and
equipment and right-of-use assets /H1118/H1118/H11181,848 0.3 4,365 0.5
Asset impairment loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 21,350 2.6
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/H11184,200 0.8 9,477 1.1
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/H1118558,997 100.0 836,726 100.0
Administrative Expenses
During the Track Record Period, our administrative expenses primarily consisted of (i)
staff costs, including wages, bonus, social insurance and other welfare, as well as share
incentive expenses in relation to Pre-IPO Equity Incentive Plan for our administrative
personnel, see “Statutory and General Information — D. Share Incentive Plan — Pre-IPO
Equity Incentive Plan” for details, (ii) professional services expenses, primarily in relation to
our equity financing and business collaboration activities, (iii) listing expenses, (iv)
depreciation of property, plant and equipment and right-of-use assets, and (v) office, traveling
and other expenses. The following table sets forth a breakdown of our administrative expenses
in absolute amounts and as percentages of the total administrative expenses for the periods
indicated.
For the year ended December 31,
2023 2024
(RMB’000) % (RMB’000) %
Staff costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111822,754 36.4 91,259 57.5
Professional services expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111830,274 48.4 29,818 18.8
Listing expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 24,145 15.2
Depreciation of property, plant and
equipment and right-of-use assets /H1118/H1118/H11183,139 5.0 3,505 2.2
Office, traveling and other expenses /H1118/H1118/H11186,400 10.2 9,965 6.3
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/H111862,567 100.0 158,692 100.0
FINANCIAL INFORMATION
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--- page 460 ---
Other Income
During the Track Record Period, our other income primarily consisted of (i) government
grants, primarily representing government subsidies from government authorities in relation to
our R&D activities, which were mainly one-off in nature, and (ii) others, primarily representing
refunds in relation to individual income tax. The following table sets forth a breakdown of our
other income in absolute amounts and as percentages of the total other income for the periods
indicated.
For the year ended December 31,
2023 2024
(RMB’000) % (RMB’000) %
Government grants /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,154 96.7 7,124 97.1
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/H1118107 3.3 214 2.9
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/H11183,261 100.0 7,338 100.0
Other Gains, Net
During the Track Record Period, our net other gains primarily consisted of net foreign
exchange gains, as a result of fluctuations in currency exchange. The following table sets forth
a breakdown of our net other gains in absolute amounts and as percentages of the total net other
gains for the periods indicated.
For the year ended December 31,
2023 2024
(RMB’000) % (RMB’000) %
Foreign exchange gains, net /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111841,935 102.8 12,273 85.1
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(1,162) (2.8) 2,148 14.9
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/H111840,773 100.0 14,421 100.0
Finance Income
Our finance income represents interest income from bank deposits, which amounted to
RMB34.5 million and RMB48.1 million in 2023 and 2024, respectively.
Finance Costs
Our finance costs represent interest expenses on lease liabilities, which amounted to
RMB188 thousand and RMB250 thousand in 2023 and 2024, respectively.
FINANCIAL INFORMATION
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--- page 461 ---
Fair Value Change of Financial Liabilities at Fair Value through Profit or Loss
Our financial liabilities at fair value through profit or loss primarily represented our
Preferred Shares issued in our previous equity financings. See “— Description of Selected
Items from the Consolidated Balance Sheets — Financial Liabilities at Fair V alue through
Profit or Loss” for details. The fair value changes of our financial liabilities are recognized in
profit or loss unless they are related to our own credit risk, which are recognized in other
comprehensive loss. Our fair value change of financial liabilities at fair value through profit
or loss amounted to loss of RMB1,017.9 million and RMB873.4 million in 2023 and 2024,
respectively. For more details, please refer to note 25 to the Accountant’s Report set out in
Appendix I to this prospectus.
Income Tax Expense
Our income tax expenses amounted to RMB155.3 million and RMB35.9 million in 2023
and 2024, respectively. Our income tax expenses during the Track Record Period were mainly
in relation to withholding tax on our overseas income. No deferred tax asset has been
recognized in respect of the tax losses and temporary difference due to the unpredictability of
future profit streams.
The current income tax charge is calculated on the basis of the tax laws enacted or
substantively enacted at the end of the reporting period in the countries where we operate and
generate taxable income. Our management periodically evaluates positions taken in tax returns
with respect to situations in which applicable tax regulation is subject to interpretation and
considers whether it is probable that a taxation authority will accept an uncertain tax treatment.
We measure our tax balances either based on the most likely amount or the expected value,
depending on which method provides a better prediction of the resolution of the uncertainty.
Our principal applicable taxes and tax rates are set out below.
Cayman Islands
Under the current laws of the Cayman Islands, our Company is not subject to tax on
income or capital gains. Additionally, the Cayman Islands does not impose a withholding tax
on payments of dividends to shareholders.
Hong Kong
Under the current Hong Kong Inland Revenue Ordinance, our subsidiary in Hong Kong
is subject to Hong Kong profit tax on its taxable income generated from operations in Hong
Kong at two-tiered profit tax rates, 8.25% for first HK$2 million of assessable profits and
16.5% for assessable profits above HK$2 million. Additionally, payments of dividends by the
subsidiary incorporated in Hong Kong to the Company are not subject to any Hong Kong
withholding tax. No provision for Hong Kong profits tax has been provided for at the rate of
16.5% as our subsidiary in Hong Kong had no estimated assessable profit during the Track
Record Period.
FINANCIAL INFORMATION
– 451 –


--- page 462 ---
United States
DualityBio Inc. is incorporated in the United States and is subject to federal income tax
at 21% and state and local income tax (generally ranges from 1% to 12%) where it has
operation. DualityBio Inc. did not have any taxable income, therefore no income tax expense
was accrued for the Track Record Period.
Mainland China
Duality Suzhou is subject to corporate income tax at a rate of 15% as its “High and New
Technology Enterprises” certificate was obtained on November 19, 2024 with a valid period of
three years. Duality Shanghai is subject to corporate income tax at a rate of 25%. Duality
Beijing, incorporated in the PRC, as a small and micro enterprise, is eligible for a corporate
income tax rate of 20% on 25% of its taxable income for portions not exceeding RMB3.0
million.
According to the CIT Law and the respective regulations, the income derived by a
resident enterprise in China from the transfer of technology which meets certain prescribed
criteria could be eligible for income tax incentives. The part of the annual income from the
transfer of technology derived by a resident enterprise within RMB5.0 million shall be
tax-exempt; and the remainder shall be subject to a 50% reduction in the enterprise income tax
rate. During the year ended December 31, 2023 and 2024, Duality Suzhou incurred income of
transfer of technology for the above mentioned tax reduction and exemption incentives.
No provision for Mainland China profits tax has been provided for at a rate of 15%, 20%
or 25% pursuant to the CIT Law and the respective regulations, as we had no estimated
assessable profits during the Track Record Period.
Withholding Tax
According to the CIT rules and regulations, distribution of profits earned by PRC
companies is generally subject to a withholding tax of 10% upon the distribution of profits to
overseas-incorporated immediate holding companies. Depending on the tax residency of the
foreign shareholder, the withholding tax rate may be adjusted based on the relevant bilateral
tax treaty. During the years ended December 31, 2023 and 2024, we did not have any profit
distribution plan.
Withholding tax on revenue from out-licensing
We have entered into a number of out-license and collaboration agreements with certain
overseas customers. According to the local income tax rules and regulations in the tax
jurisdictions of the customers, a withholding tax might be triggered for the whole or part of the
income arising from the license and collaboration agreements.
FINANCIAL INFORMATION
– 452 –


--- page 463 ---
Loss for the Y ear
As a result of the foregoing, we incurred losses of RMB357.5 million and RMB1,050.4
million for the years ended December 31, 2023 and 2024, respectively.
PERIOD-TO-PERIOD COMPARISON OF RESULTS OF OPERATIONS
Y ear Ended December 31, 2024 Compared to Y ear Ended December 31, 2023
Revenue
Our revenue increased from RMB1,786.5 million in 2023 to RMB1,941.3 million in 2024,
primarily due to an increase in reimbursement for R&D activities.
Cost of Revenue
Our cost of revenue increased from RMB427.7 million in 2023 to RMB1,156.6 million
in 2024, primarily in relation to the R&D activities we conducted in accordance with our
out-license and collaboration agreements.
Gross Profit and Gross Profit Margin
Our gross profit decreased from RMB1,358.9 million in 2023 to RMB784.7 million in
2024. Our overall gross profit margin decreased from 76.1% in 2023 to 40.4% in 2024. The
decreases in gross profit and gross profit margin are primarily because the revenue in 2023 was
primarily derived from upfront payments, while the revenue in 2024 was primarily derived
from reimbursement for R&D activities.
Research and Development Expenses
Our research and development expenses increased by 49.7% from RMB559.0 million in
2023 to RMB836.7 million in 2024, primarily due to (i) an increase of RMB144.9 million in
staff costs mainly due to increase in share incentive expenses, as we recognized more expenses
in accordance with the vesting conditions under our Pre-IPO Equity Incentive Plan in 2024, and
(ii) an increase of RMB103.7 million in CRO and CDMO technical service expenses as we
initiated several new trials in 2023 and 2024 and accordingly had more clinical trials in
progress and more patients enrolled.
Administrative Expenses
Our administrative expenses increased by 153.6% from RMB62.6 million in 2023 to
RMB158.7 million in 2024, primarily due to (i) an increase of RMB68.5 million in staff costs
mainly due to increase in share incentive expenses, as we recognized more expenses in
accordance with the vesting conditions under our Pre-IPO Equity Incentive Plan in 2024, and
(ii) RMB24.1 million of Listing expenses.
FINANCIAL INFORMATION
– 453 –


--- page 464 ---
Other Income
Our other income increased from RMB3.3 million in 2023 to RMB7.3 million in 2024,
primarily due to an increase of RMB4.0 million in government grants.
Other Gains, Net
We recorded net other gains of RMB40.8 million in 2023, which decreased to RMB14.4
million in 2024, primarily due to the exchange rate fluctuations between U.S. dollar and
Renminbi. During the Track Record Period, U.S. dollar-denominated balances consistently
represented approximately 50% or more of our cash and cash equivalents.
Finance Income
Our finance income increased from RMB34.5 million in 2023 to RMB48.1 million in
2024, primarily because we had increased bank deposits as a result of increased cash derived
from our out-license and collaboration agreements.
Finance Costs
Our finance costs increased from RMB188 thousand in 2023 to RMB250 thousand in
2024, primarily because we expanded the area of our leased properties in 2024 as we leased
more space as our operations grew.
Fair V alue Change of Financial Liabilities at Fair V alue Through Profit or Loss
We recorded a fair value loss of financial liabilities at fair value through profit or loss of
RMB1,017.9 million and RMB873.4 million in 2023 and 2024, respectively. The fair value
change of financial liabilities at fair value through profit or loss was mainly in relation to
changes in the fair value of our Preferred Shares.
Income Tax Expense
Our income tax expense decreased from RMB155.3 million in 2023 to RMB35.9 million
in 2024 as we had less withholding tax in 2024.
Loss for the Period
For the reasons discussed above, we recorded loss for the period of RMB357.5 million
and RMB1,050.4 million in 2023 and 2024, respectively.
FINANCIAL INFORMATION
– 454 –


--- page 465 ---
DESCRIPTION OF SELECTED ITEMS FROM THE CONSOLIDATED BALANCE
SHEETS
The following table sets forth a summary of our consolidated balance sheets as of the
dates indicated.
As of December 31,
2023 2024
(RMB’000) (RMB’000)
Non-current assets
Property, plant and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111812,313 13,072
Intangible assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111854,248 46,237
Right-of-use assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,445 5,523
Other non-current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111894,008 115,555
Total non-current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118166,014 180,387
Current assets
Cash and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,130,889 1,208,906
Restricted cash /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111842,645 45,155
Term deposits with initial term over three months /H1118/H1118 – 181,766
Trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,803 379,021
Prepayments and other receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111827,024 24,598
Other current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111832,534 70,389
Total current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,333,895 1,909,835
Total assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,499,909 2,090,222
Current liabilities
Financial liabilities at fair value through profit or
loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,132,720 3,046,784
Trade payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118234,814 670,910
Other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111834,674 60,631
Contract liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118156,132 90,256
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,906 2,987
Total current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,561,246 3,871,568
Net current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,227,351) (1,961,733)
Total assets less current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,061,337) (1,781,346)
Non-current liabilities
Contract liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111860,164 238,251
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,412 2,302
Total non-current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111862,576 240,553
Total liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,623,822 4,112,121
Net liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,123,913) (2,021,899)
FINANCIAL INFORMATION
– 455 –


--- page 466 ---
Property, Plant and Equipment
During the Track Record Period, our property, plant and equipment primarily consisted of
equipment in our offices and facilities, leasehold improvements as well as construction in
progress. Our property, plant and equipment increased from RMB12.3 million as of December
31, 2023 to RMB13.1 million as of December 31, 2024, primarily due to the expansion of our
business operations leading to the increase in the size and number of our offices and the
improvement of laboratory.
Intangible Assets
During the Track Record Period, our intangible assets primarily consisted of (i)
in-licenses and in-progress research and development, primarily in relation to certain
antibodies we licensed in from third parties, see “Business — Our Collaboration and Licensing
Arrangements” for details, and (ii) software. The following table sets forth the details of our
intangible assets as of the dates indicated.
As of December 31,
2023 2024
(RMB’000) (RMB’000)
In-licenses and in-progress 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/H111853,757 42,048
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/H1118491 4,189
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/H111854,248 46,237
Our intangible assets decreased from RMB54.2 million as of December 31, 2023 to
RMB46.2 million as of December 31, 2024. The decrease was primarily because (i) we
suspended the development of a drug candidate and accordingly recorded a full allowance for
the impairment of the in-licensed antibody used in its development, and (ii) certain amounts
were recognized as cost of revenue in accordance with our out-licensing arrangements.
The intangible assets related to in-licenses and in-progress research and development are
not ready for use and we are continuing their research and development. Impairment tests were
performed in respect of these intangible assets based on the recoverable amount of the
cash-generating unit to which the intangible asset is related. The appropriate cash-generating
unit is at the product level.
FINANCIAL INFORMATION
– 456 –


--- page 467 ---
The impairment test was performed for each pipeline product by engaging an independent
appraiser to estimate fair value less cost to sell as the recoverable amount of each pipeline
product. The fair value was estimated using the multi-period excess earnings method and the
Group estimated the forecast of profit for its pipeline products based on the timing of clinical
development and regulatory approval, commercial ramp up to reach expected peak revenue
potential, potential upfront fee under license agreements, and the length of exclusivity for each
pipeline product. The discount rate used is post-tax and reflects specific risks relating to the
relevant products.
The following tables set forth details of the annual impairment tests for our key drug
candidates with balances in in-licenses and in-progress research and development as of
December 31, 2024.
DB-1310 As of December 31,
2023 2024
Post-tax discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816.0% 15.0%
Revenue growth rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118-6% to 140% -6% to 140%
Recoverable amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H111884,406 238,287
Carrying amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111810,790 10,790
DB-1419 As of December 31,
2023 2024
Post-tax discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816.0% 15.0%
Revenue growth rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118-8.7% to 218% -8.7% to 218%
Recoverable amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H111874,834 172,888
Carrying amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,349 10,077
DB-1311 As of December 31,
2023 2024
Post-tax discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816.0% 15.0%
Revenue growth rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118-10% to 160% -10% to 160%
Recoverable amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118140,526 336,571
Carrying amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,931 5,563
FINANCIAL INFORMATION
– 457 –


--- page 468 ---
DB-1418 As of December 31,
2023 2024
Post-tax discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Not applicable 15.0%
Revenue growth rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Not applicable -5% to 333.9%
Recoverable amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118Not applicable 66,711
Carrying amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118– 6,703
DB-1324 As of December 31,
2023 2024
Post-tax discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Not applicable 15.0%
Revenue growth rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Not applicable
-19.6% to
246.1%
Recoverable amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118Not applicable 235,392
Carrying amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118– 8,915
We also perform sensitivity test by increasing one percentage of post-tax discount rate or
decreasing one percentage of revenue growth rate, which our management considers are the
key assumptions to determine the recoverable amount of each intangible asset, with all other
variables held constant.
For more details, please refer to note 16 to the Accountant’s Report set out in Appendix
I to this prospectus.
Based on the result of the assessment, there was no impairment for the in-licenses and
in-progress research and development as of December 31, 2023. Considering there was
sufficient headroom based on the assessment, our Directors and management believe that a
reasonably possible change in any of the key assumptions would not cause the relevant
carrying amount of the cash generating unit to exceed its recoverable amount, and that there
was no impairment as of December 31, 2024, except that we suspended the development of a
drug candidate and accordingly recorded a full allowance for the impairment of the in-licensed
antibody used in its development.
Right-of-use Assets
During the Track Record Period, our right-of-use assets represents leases of offices and
laboratory. Our right-of-use assets increased from RMB5.4 million as of December 31, 2023
to RMB5.5 million as of December 31, 2024, primarily due to our new leases, offset by the
depreciation of the right-of-use assets.
FINANCIAL INFORMATION
– 458 –


--- page 469 ---
Other Non-current Assets
During the Track Record Period, our other non-current assets primarily consisted of (i)
withholding tax recoverable mainly in relation to the withholding tax deducted from payments
made by our overseas collaboration partners in accordance with local regulations, a portion of
which may be refunded to us by virtue of the tax treaty between the local jurisdiction and
China, and (ii) others, primarily representing non-current prepayments incurred during our
business operation. The following table sets forth the details of our other non-current assets as
of the dates indicated.
As of December 31,
2023 2024
(RMB’000) (RMB’000)
Tax deduction related to
withholding tax /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111893,666 115,400
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118342 155
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/H111894,008 115,555
Our other non-current assets increased from RMB94.0 million as of December 31, 2023
to RMB115.6 million as of December 31, 2024, primarily due to the increase of withholding
tax recoverable caused by the increase of our revenue from collaboration partners.
As of February 28, 2025, none of our withholding tax recoverable as of December 31,
2024 had been subsequently recovered. During the Track Record Period and up to the Latest
Practicable Date, we had not encountered any recoverability issue in relation to our
withholding tax recoverable.
Withholding tax receivables as of December 31, 2024 mainly represents
RMB110,962,000 in withholding tax receivable from the Federal Central Tax Office, Germany,
attributable to excess withholding tax withheld and paid by our overseas collaboration partner
in Germany based on the normal statutory withholding tax rate of 15.825%. According to the
double tax treaty between China and Germany, Duality Suzhou, as the recipient of the payment
and a Chinese tax resident, is eligible to apply for a reduced withholding tax rate of 10%.
Duality Suzhou has submitted an application for this treaty benefit and received a formal
withholding tax exemption certificate issued by the Federal Central Tax Office. The certificate
confirms that Duality Suzhou is entitled to the reduced withholding tax rate of 10% for license
payments received. The refund process for the recoverable portion of withholding tax is
currently ongoing. We do not anticipate material issues regarding the recoverability of the
withholding tax recoverable.
FINANCIAL INFORMATION
– 459 –


--- page 470 ---
Cash and Cash Equivalents
During the Track Record Period, our cash and cash equivalents primarily consisted of
cash in bank and in hand, denominated on Renminbi, U.S. dollar and Euro. The following table
sets forth the details of our cash in bank and on hand as of the dates indicated.
As of December 31,
2023 2024
(RMB’000) (RMB’000)
Cash in bank and on hand are denominated in:
U.S. dollar /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118558,170 943,255
Renminbi /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118570,485 263,666
Euro /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,234 1,985
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/H11181,130,889 1,208,906
Our cash and cash equivalents increased from RMB1,130.9 million as of December 31,
2023 to RMB1,208.9 million as of December 31, 2024, primarily due to our increased revenue
from out-license and collaboration agreements.
Term deposits with initial term over three months
Term deposits with initial term over three months represents our bank deposits in U.S.
dollar with maturities over three months and less than one year. As of December 31, 2023 and
2024, our term deposits with initial term over three months was nil and RMB181.8 million,
respectively.
Financial Assets at Fair Value through Profit or Loss
As part of our cash management policy, we purchase wealth management products to
better utilize our idle cash without interfering with our business operations or capital
expenditures. During the Track Record Period, we purchased structured deposits issued by
reputable commercial banks in the PRC, with a floating return being paid together with the
principal on the maturity date, which were recognized as financial assets at fair value through
profit or loss. As of December 31, 2023 and 2024 and February 28, 2025, the balances of our
financial assets at fair value through profit or loss were nil, nil and RMB90.0 million,
respectively.
To monitor and control the investment risks associated with our financial assets at fair
value through profit or loss, we have adopted a comprehensive set of internal policies and
guidelines to manage our investment in financial assets at fair value through profit or loss. We
make investment decisions based on our estimated capital requirements and our annual budget,
taking into account the duration, expected returns and risks of the wealth management product.
We generally limit our purchases to low-risk and short-term products which are redeemable on
demand from reputable commercial banks.
FINANCIAL INFORMATION
– 460 –


--- page 471 ---
After Listing, we may continue to purchase low-risk wealth management products with
a short maturity period based on our operational needs, strictly in accordance with our internal
policies and measures and the requirements under Chapter 14 of the Listing Rules.
Restricted Cash
During the Track Record Period, our restricted cash represented the restricted deposits
held in designated bank accounts mainly as security deposits for derivative financial
instruments, denominated in U.S. dollars.
Trade Receivables
During the Track Record Period, our trade receivables consisted of receivables from our
collaboration partners for payment obligations set out in the relevant agreements, primarily
including reimbursement payments and a milestone payment as of the balance sheet dates. The
following table sets forth the details of our trade receivables as of the dates indicated.
As of December 31,
2023 2024
(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/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,888 379,545
Less: provision for impairment of
trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(85) (524)
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/H1118100,803 379,021
Our trade receivables increased significantly from RMB100.8 million as of December 31,
2023 to RMB379.0 million as of December 31, 2024, generally in line with the R&D activities
we conducted in relation to our out-license and collaboration programs.
The following table sets forth an aging analysis of our trade receivables presented based
on the invoice date and net of expected credit losses as of the dates indicated.
As of December 31,
2023 2024
(RMB’000) (RMB’000)
Within 30 days /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,803 377,783
31 days to 60 days /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 1,238
Total trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,803 379,021
FINANCIAL INFORMATION
– 461 –


--- page 472 ---
As of February 28, 2025, RMB61.4 million, or 16.2%, of our trade receivables as of
December 31, 2024 had been subsequently settled. Up to the Latest Practicable Date, all of our
trade receivables as of December 31, 2024 had been subsequently settled. There had been no
material recoverability issue for our trade receivable balance during the Track Record Period
and up to the Latest Practicable Date and we believe sufficient provision has been made.
Prepayments and Other Receivables
During the Track Record Period, our prepayments and other receivables primarily
consisted of (i) prepayments to suppliers in our R&D activities, (ii) deposits for our leases and
in relation to staff compensation, and (iii) deferred listing expenses.
As of December 31,
2023 2024
(RMB’000) (RMB’000)
Prepayments to suppliers /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,746 14,057
Deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,264 6,290
Deferred listing expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 4,205
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814 46
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/H111827,024 24,598
Our prepayments and other receivables decreased from RMB27.0 million as of
December 31, 2023 to RMB24.6 million as of December 31, 2024. The level of our
prepayments and other receivables primarily depends on our R&D activities and business
operation.
Contract Assets
Our contract assets relate to reimbursement payments pursuant to our out-license and
collaboration agreements. Costs incurred that have not yet been settled with our partners are
classified as contract assets and will be accounted for as cost of revenue at each quarter end,
after quarterly settlements with our partners. See “Business — Our Collaboration and
Licensing Arrangements” for details. Our contract assets amounted to RMB96.4 million as of
February 28, 2025.
Other Current Assets
During the Track Record Period, our other current assets represent value-added tax
recoverable. Our other current assets increased from RMB32.5 million as of December 31,
2023 to RMB70.4 million as of December 31, 2024. This growth was primarily driven by the
expansion of our operations and the resulting increase in procurement activities. Additionally,
the amount of V A T we paid on inputs exceeded the V A T collected on sales, contributing to the
rise in our V A T recoverable.
FINANCIAL INFORMATION
– 462 –


--- page 473 ---
Financial Liabilities at Fair Value Through Profit or Loss
Our financial liabilities at fair value through profit or loss primarily represented the
Preferred Shares issued in our previous equity financings. Our Preferred Shares are recorded
as financial liabilities at fair value through profit or loss (current). Effective from January 1,
2024, “IAS 1 (Amendment) ‘Classification of Liabilities as current or non-current’” requires
a reclassification of convertible preferred shares from non-current liabilities to current
liabilities, as the convertible preferred shares may be converted into ordinary shares at the
option of the preferred shareholders at any time and the conversion feature does not meet
“fixed-for-fixed” criteria. See “— Material Accounting Policies and Significant Accounting
Judgments and Estimates — Financial Liabilities at Fair V alue Through Profit or Loss” for
details. These Preferred Shares will be converted into Ordinary Shares upon Listing, after
which the amount of our financial liabilities at fair value through profit or loss will be
derecognized from our liabilities and recorded as equity.
Our financial liabilities at fair value through profit or loss increased from RMB2.1 billion
as of December 31, 2023 to RMB3.0 billion as of December 31, 2024 primarily due to the
changes in fair value of our Preferred Shares.
Trade Payables
During the Track Record Period, our trade payables primarily consisted of payables in
relation to our research and development activities. Our trade payables increased from
RMB234.8 million as of December 31, 2023 to RMB670.9 million as of December 31, 2024.
The continuous increase of our trade payables was primarily due to the expanded scale of our
R&D activities.
The following table sets forth an aging analysis of our trade payables presented based on
the invoice date as of the dates indicated.
As of December 31,
2023 2024
(RMB’000) (RMB’000)
Within 6 months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118234,476 670,199
6 months to 12 months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118338 711
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/H1118234,814 670,910
As of February 28, 2025, RMB168.7 million, or 25.1%, of our trade payables as of
December 31, 2024 had been subsequently settled.
Our Directors confirm that there has not been any material default on our part in the
payment of trade payables during the Track Record Period and up to the Latest Practicable
Date.
FINANCIAL INFORMATION
– 463 –


--- page 474 ---
Other Payables
During the Track Record Period, our other payables consisted of (i) staff salaries and
welfare payables, (ii) payables for acquisition of property, plant and equipment and intangible
assets, (iii) payables for listing expenses, (iv) other taxes payable, (v) payables for financial
and consulting services, (vi) recruitment services and other accrued expenses, and (vii) others.
The following table sets forth the details of our other payables as of the dates indicated.
As of December 31,
2023 2024
(RMB’000) (RMB’000)
Staff salaries and welfare payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,587 38,496
Payables for acquisition of property, plant and
equipment and
intangible assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11187,408 10,114
Payables for listing expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 8,822
Other taxes payable /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118919 1,718
Payables for financial and
consulting services /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,651 390
Recruitment services and other
accrued expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–8 5
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,109 1,006
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/H111834,674 60,631
Our other payables increased from RMB34.7 million as of December 31, 2023 to
RMB60.6 million as of December 31, 2024, primarily due to an increase of RMB14.9 million
in staff salaries and welfare payables, as well as the payables for listing expenses. As of
February 28, 2025, RMB13.5 million, or 22.2%, of our other payables as of December 31, 2024
had been subsequently settled.
Our Directors confirm that there has not been any material default on our part in the
payment of other payables during the Track Record Period and up to the Latest Practicable
Date.
Contract Liabilities
Our contract liabilities primarily represented amounts paid by our collaboration partners
in relation to our out-license and collaboration agreements before we fulfilled corresponding
performance obligations. The excess of our cumulative billings to customers over the
cumulative revenue recognized in profit or loss is recognized as contract liabilities. See
“Business — Our Collaboration and Licensing Arrangements” for details. Our contract
liabilities amounted to RMB216.3 million as of December 31, 2023 and increased to
RMB328.5 million as of December 31, 2024, primarily because we entered into an exclusive
option agreement in 2024 and received an upfront payment, and the collaboration partner had
not exercised the option as of December 31, 2024. As of February 28, 2025, RMB21.8 million,
or 6.6%, of our contract liabilities as of December 31, 2024 had been recognized as revenue.
FINANCIAL INFORMATION
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--- page 475 ---
Lease Liabilities
Our lease liabilities primarily consisted of leases of offices and laboratory. During the
Track Record Period, our lease liabilities remained stable at RMB5.3 million as of December
31, 2023 and 2024.
LIQUIDITY AND CAPITAL RESOURCES
Our primary uses of cash during the Track Record Period were to fund our research and
development activities. During the Track Record Period, we conducted series B and B+
financing and also generated cash inflow from our out-license and collaboration agreements.
We recorded net cash from operating activities of RMB816.3 million and RMB285.8 million
for the year ended December 31, 2023 and 2024, respectively. As of February 28, 2025, being
the latest practicable date for determining our indebtedness, we had cash and cash equivalents,
term deposits with initial term over three months (principal-protected and available for early
withdrawal at any time), restricted cash and financial assets at fair value through profit or loss
of RMB1,880.7 million.
Current Assets and Liabilities
As of December 31,
As of
February 28,
2023 2024 2025
(RMB’000) (RMB’000) (RMB’000)
(Unaudited)
Current assets
Cash and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,130,889 1,208,906 1,023,286
Restricted cash /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111842,645 45,155 45,297
Term deposits with initial term over three
months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 181,766 722,091
Trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,803 379,021 326,774
Prepayments and other receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111827,024 24,598 25,710
Contract assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 96,392
Financial assets at fair value through profit
or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 90,000
Other current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111832,534 70,389 4,550
Total current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,333,895 1,909,835 2,334,100
Current liabilities
Financial liabilities at fair value through
profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,132,720 3,046,784 3,175,338
Trade payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118234,814 670,910 697,660
Other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111834,674 60,631 64,511
Contract liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118156,132 90,256 74,757
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,906 2,987 2,525
Total current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,561,246 3,871,568 4,014,791
Net current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,227,351) (1,961,733) (1,680,691)
FINANCIAL INFORMATION
– 465 –


--- page 476 ---
We recorded net current liabilities during the Track Record Period primarily because our
Preferred Shares issued to Pre-IPO investors are recorded as current liabilities under financial
liabilities at fair value through profit or loss. These Preferred Shares will be converted into
Ordinary Shares upon Listing, after which the amount of our financial liabilities at fair value
through profit or loss, which were recorded as our current liabilities during the Track Record
Period, will be derecognized from our liabilities and recorded as equity, which can result in the
Group turning into net current assets and net assets position. See “— Description of Selected
Items from the Consolidated Balance Sheets — Financial Liabilities at Fair V alue through
Profit or Loss” for details.
We expect to continue to incur significant expenses for the foreseeable future as we
advance our ADC candidates, which will be funded by a combination of our cash on hand, our
income from out-license and collaboration agreements, and proceeds from the Global Offering.
Working Capital Sufficiency
Although we recorded significant net current liabilities during the Track Record Period,
our Directors are of the view that we have sufficient working capital to cover at least 125% of
our costs, including research and development expenses and administrative expenses
(including any production costs), for at least the next 12 months from the date of this
prospectus, primarily for the reasons set out below:
 Cash on hand and cash inflow from our operations. We had cash and cash
equivalents, term deposits with initial term over three months (principal protected
and available for early withdrawal at any time) and restricted cash together
amounting to RMB1,435.8 million as of December 31, 2024. We expect to receive
milestone payments from our out-license and collaboration agreements in the future,
and intend to utilize them to fund our operations, subject to the achievement of
certain milestones and other terms of these agreements. See “Business — Our
Collaboration and Licensing Arrangements” for details. Furthermore, upon the
successful commercialization of one or more of our ADC candidates, we expect to
fund our operations in part with income generated from sales of our commercialized
drugs.
 Conversion of Preferred Shares upon Listing. As of December 31, 2024, we
recorded RMB3,046.8 million in financial liabilities at fair value through profit or
loss, which were attributable to the Preferred Shares we issued to Pre-IPO Investors.
These Preferred Shares will be converted into Ordinary Shares upon Listing, after
which our financial liabilities at fair value through profit or loss, which were
recorded as current liabilities during the Track Record Period, will be derecognized
from our liabilities and recorded as equity, which can result in the Group turning
into net current assets and net assets position. See “— Description of Selected Items
from the Consolidated Balance Sheets — Financial Liabilities at Fair V alue through
Profit or Loss” for details.
FINANCIAL INFORMATION
– 466 –


--- page 477 ---
 Cash burn rate. Our cash burn rate refers to the average monthly amount of cash
used in operating activities, payment for property, plant and equipment and payment
for intangible assets, without taking into account the cash inflow from out-licensing
and collaboration agreements. We estimate that we will receive net proceeds of
approximately HK$1,308.4 million in the Global Offering, assuming an Offer Price
of HK$94.60 per Share, being the low end of the indicative Offer Price range stated
in this prospectus. Assuming an average cash burn rate going forward of 1.2 times
the level in 2024, we estimate that (i) our cash and cash equivalents as of December
31, 2024 will be able to maintain our financial viability for 19 months, (ii) if we take
into account 10.0% of the estimated net proceeds from the Global Offering (namely,
the portion allocated for our working capital and other general corporate purposes),
21 months, or, (iii) if we take into account all estimated net proceeds from the
Global Offering, 39 months. We will continue to monitor our cash flows from
operations closely and expect to raise our next round of financing no earlier than six
months after the completion of the Global Offering.
Cash Flows
The following table sets forth the components of our consolidated statements of cash
flows for the periods indicated:
For the year ended December 31,
2023 2024
(RMB’000) (RMB’000)
Operating cash flows before movement in working
capital /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118790,947 31,559
Changes in working capital /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118239,834 260,650
Income tax paid /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(248,929) (54,540)
Interest received /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111834,483 48,112
Net cash from operating activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118816,335 285,781
Net cash (used in) investing activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(78,550) (211,151)
Net cash from/(used in) financing activities /H1118/H1118/H1118/H1118/H1118/H111810,817 (7,621)
Net increase in cash and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118748,602 67,009
Cash and cash equivalents at beginning of year /H1118/H1118/H1118375,974 1,130,889
Effect of foreign exchange rate changes /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,313 11,008
Cash and cash equivalents at the end of year /H1118/H1118/H1118/H11181,130,889 1,208,906
FINANCIAL INFORMATION
– 467 –


--- page 478 ---
Net Cash From Operating Activities
For the year ended December 31, 2024, we had net cash from operating activities of
RMB285.8 million, which was primarily attributable to our loss before taxation of
RMB1,014.5 million adjusted by certain non-cash and working capital items, including (i)
positive adjustments, which primarily included fair value losses on financial liabilities at fair
value through profit or loss of RMB873.4 million, increase in trade and other payables of
RMB463.1 million, share-based compensation expenses of RMB190.4 million and contract
liabilities of RMB112.2 million, and (ii) negative adjustments, which primarily included
increase in trade, other receivables and prepayments of RMB276.8 million, finance income of
RMB48.1 million and increase in other current assets of RMB37.9 million.
For the year ended December 31, 2023, we had net cash from operating activities of
RMB816.3 million, which was primarily attributable to our loss before taxation of RMB202.2
million adjusted by certain non-cash and working capital items, including (i) positive
adjustments, which primarily included fair value losses on financial liabilities at fair value
through profit or loss of RMB1,017.9 million and an increase of RMB216.3 million in contract
liabilities, and (ii) negative adjustments, which primarily included an increase of RMB121.0
million in trade, other receivables and prepayments, net foreign exchange gains of RMB41.9
million and finance income of RMB34.5 million.
Net Cash Used in Investing Activities
For the year ended December 31, 2024, we had net cash used in investing activities of
RMB211.2 million, primarily attributable to (i) increase in term deposits with initial term over
three months of RMB179.7 million, (ii) purchase of intangible assets of RMB27.1 million, (iii)
purchase of property, plant and equipment of RMB4.1 million, and (iv) changes in restricted
cash balances of RMB2.5 million.
For the year ended December 31, 2023, we had net cash used in investing activities of
RMB78.6 million, primarily attributable to (i) purchase of intangible assets of RMB24.6
million, (ii) purchase of property, plant and equipment of RMB11.3 million, and (iii) changes
in restricted cash balances of RMB42.7 million.
Net Cash From/(Used in) Financing Activities
For the year ended December 31, 2024, we had net cash used in financing activities of
RMB7.6 million, primarily attributable to (i) principal component of lease payments of
RMB3.4 million, and (ii) payment of listing expenses of RMB3.3 million.
For the year ended December 31, 2023, we had net cash from financing activities of
RMB10.8 million, primarily attributable to proceeds from issuance of Preferred Shares issued
of RMB151.1 million; partially offset by (i) repayments of loans with warrants to purchase
Series B-2 Preferred Shares from holders of Preferred Shares of RMB135.2 million, see “—
Description of Selected Items from the Consolidated Balance Sheets — Financial Liabilities at
Fair V alue through Profit or Loss” for details, (ii) settlement of financial assets at fair value
through profit or loss of RMB1.2 million, and (iii) principal component of lease payments of
RMB3.5 million.
FINANCIAL INFORMATION
– 468 –


--- page 479 ---
CASH OPERATING COSTS
The following table sets forth our cash operating costs for the periods indicated:
For the year ended December 31,
2023 2024
(RMB’000) (RMB’000)
Costs relating to research and development of
our Core Products
Clinical costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118237,700 474,758
Nonclinical costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118155,074 292,305
In-license costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111884,670 18,810
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118477,444 785,873
Costs relating to research and development of
our other drug candidates
Clinical costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111872,953 180,959
Nonclinical costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118231,799 301,816
In-license costs /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,554 12,779
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118313,306 495,554
Labor cost for research and development staff /H1118/H1118/H1118/H111879,806 106,062
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/H1118870,556 1,387,489
Labor cost for non-research and development
staff /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111813,865 42,475
Operating 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/H111843,690 67,916
INDEBTEDNESS
As of December 31, 2023 and 2024 and February 28, 2025, being the most recent
practicable date for determining our indebtedness, except as disclosed in the table below, we
did not have any material indebtedness.
As of December 31,
As of
February 28,
2023 2024 2025
(RMB’000) (RMB’000) (RMB’000)
(Unaudited)
Current
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,906 2,987 2,525
Financial liabilities at
fair value through
profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,132,720 3,046,784 3,175,338
Non-current
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,412 2,302 2,147
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/H11182,138,038 3,052,073 3,180,010
FINANCIAL INFORMATION
– 469 –


--- page 480 ---
Except as discussed above, we did not have any other 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 as of 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 material
breach of covenants during the Track Record Period and up to the Latest Practicable Date.
As of the Latest Practicable Date, we had unutilized banking facilities of RMB600.0
million. Our Directors confirm that there have been no material changes in our indebtedness
since February 28, 2025, being the latest practicable date for determining our indebtedness, up
to the date of this prospectus.
CAPITAL EXPENDITURES
In 2023 and 2024, we incurred capital expenditures of RMB35.9 million and RMB33.9
million, respectively, primarily in connection with the intangible assets and purchase of
property, plant and equipment. These purchases were primarily for our R&D and business
operation. The following table sets forth the details of our capital expenditure for the periods
indicated.
For the year ended December 31,
2023 2024
(RMB’000) (RMB’000)
Purchases of property, plant and equipment /H1118/H1118/H1118/H1118/H1118/H111811,284 4,079
Purchases of intangible assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111824,621 29,860
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/H111835,905 33,939
We plan to finance our future capital expenditures primarily with our existing cash as well
as net proceeds from the Global Offering. See the section “Future Plans and Use of Proceeds”
in the prospectus for more details. We may reallocate the funds to be utilized on capital
expenditures based on our ongoing business needs.
CONTRACTUAL COMMITMENTS
Capital Commitments
As of December 31, 2023 and 2024, our capital expenditure contracted for but not yet
incurred is related to property, plant and equipment, amounting to RMB0.5 million and
RMB0.4 million.
FINANCIAL INFORMATION
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--- page 481 ---
CONTINGENT LIABILITIES
As of December 31, 2023 and 2024, we did not have any contingent liabilities. Our
Directors confirm that there has been no material change in our contingent liabilities since
December 31, 2024 to the date of this prospectus.
OFF-BALANCE SHEET COMMITMENTS AND ARRANGEMENTS
We did not have, during the years presented, and we do not currently have, any
off-balance sheet arrangements such as relationships with unconsolidated entities or financial
partnerships, which are often referred to as structured finance or special purpose entities,
established for the purpose of facilitating financing transactions that are not required to be
reflected on our balance sheets.
KEY FINANCIAL RATIOS
The following table sets forth our key financial ratios as of the dates indicated:
As of December 31,
2023 2024
Current ratio (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/H1118/H1118/H11180.5 0.5
Note:
(1) Current ratio represents current assets divided by current liabilities as of the same date.
Our current ratio decreased from 0.5 as of December 31, 2023 to 0.5 as of December 31,
2024, primarily because our cash and cash equivalents continuously increased during the Track
Record Period, partially offset by the increase in our financial liabilities at fair value through
profit or loss.
RULE 13.46(2) OF THE LISTING RULES
Rule 13.46(2) of the Listing Rules requires an overseas issuer to send an annual report or
a summary financial report to its shareholders within four months after the end of the financial
year to which the report relates. Since (1) this prospectus already includes the financial
information of the Company for the year ended December 31, 2024 as required under Appendix
D2 to the Listing Rules in relation to annual reports; (2) we will not be in breach of the Articles
of Association, laws and regulations of the Cayman Islands or other regulatory requirements
as a result of not distributing such annual reports and accounts; and (3) we have complied with
the applicable code provisions in Part 2 of the Corporate Governance Code as set out in
Appendix C1 to the Listing Rules, we will not separately prepare and publish and send an
annual report to our Shareholders for the year ended December 31, 2024. In addition, we will
issue an announcement by April 30, 2025 stating that we will not separately prepare and send
an annual report to our Shareholders for the year ended December 31, 2024 as the relevant
financial information has been included in this prospectus. We will still comply with the
requirements under Rule 13.91(5) of the Listing Rules.
FINANCIAL INFORMATION
– 471 –


--- page 482 ---
MATERIAL RELATED PARTY TRANSACTIONS
We did not have any material related party transactions during the Track Record Period.
See note 31 in the Accountant’s Report set out in Appendix I of this prospectus for details on
our transactions with related parties during the Track Record Period.
QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
Our activities expose us to a variety of financial risks: market risk (including foreign
exchange, cash flow and fair value interest rate risk), credit risk and liquidity risk. Our overall
risk management program focuses on the unpredictability of financial markets and seeks to
minimize potential adverse effects on our financial performance. Risk management is carried
out by our management. For further details, see note 3 in the Accountant’s Report set out in
Appendix I of this prospectus.
Market Risk
Foreign Exchange Risk
Foreign exchange risk arises when future commercial transactions or recognized assets
and liabilities are denominated in a currency that is not our entities’ functional currency. Our
Company’s functional currency is U.S. dollar. Our primary subsidiaries were incorporated in
the PRC and these subsidiaries considered Renminbi as their functional currency.
We operate mainly in the PRC. There are certain cash and bank balances, trade
receivables, other non-current assets, and other payables denominated in a currency that is not
the functional currency. We constantly review the economic situation and our foreign exchange
risk profile, and will consider appropriate hedging measures, as may be necessary. For further
details, see note 3.1.1 of the Accountant’s Report set out in Appendix I to this prospectus.
Cash Flow and Fair V alue Interest Rate Risk
Interest rate risk is the risk that the fair value or future cash flows of a financial
instrument will fluctuate because of changes in market interest rates. Our exposure to the risk
of changes in market interest rates relates primarily to our interest-bearing cash and cash
equivalents. When cash and cash equivalents obtained at variable rates expose us to cash flow
interest-rate risk. We have not hedged cash flow or fair value interest-rate risk. The cash and
cash equivalents are disclosed in note 17 and 19 in the Accountant’s Report set out in Appendix
I of this prospectus.
We have no significant interest-bearing assets except for cash and cash equivalents,
details of which have been disclosed in note 17 and 19 in the Accountant’s Report set out in
Appendix I of this prospectus.
FINANCIAL INFORMATION
– 472 –


--- page 483 ---
Credit Risk
Credit risk arises from cash and cash equivalents, trade receivables as well as other
receivables. The carrying amount of each class of the above financial assets represents our
maximum exposure to credit risk in relation to the corresponding class of financial assets.
To manage this risk, cash and cash equivalents are mainly deposited with state-owned or
reputable financial institutions in the PRC and reputable international financial institutions
outside of the PRC. There has been no recent history of default in relation to these financial
institutions.
For trade receivables, management applies the IFRS 9 simplified approach to measuring
expected credit losses which uses a lifetime expected loss allowance for all trade receivables.
Our Directors believe that there is no material credit risk inherent in the our outstanding
balance of trade receivables, details of which have been disclosed in note 20 in the
Accountant’s Report set out in Appendix I of this prospectus.
For other receivables and other non-current assets, our management has assessed that
during the years ended December 31, 2023 and 2024, 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. We do 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 of December 31, 2023 and 2024, we
have assessed that the expected loss rate for other receivables was immaterial. Thus no loss
allowance provision for other receivables was recognized as of December 31, 2023 and 2024.
Liquidity Risk
We aim to maintain sufficient cash and cash equivalents or have available facility through
an adequate amount of available financing to meet our daily operating working capital. For
further details, see note 3.1.3 of the Accountant’s Report set out in Appendix I to this
prospectus.
DIVIDENDS
We did not declare or pay dividends on our Shares during the Track Record Period. We
currently expect to retain all future earnings for use in operation and expansion of our business,
and do not anticipate paying cash dividends in the foreseeable future. Our board of directors
has complete discretion as to whether to distribute dividends, subject to certain restrictions
under Cayman Islands law. In addition, our Shareholders may by ordinary resolution declare
a dividend, but no dividend may exceed the amount recommended by our board of directors.
FINANCIAL INFORMATION
– 473 –


--- page 484 ---
Even if our board of directors decides to declare and pay dividends, the timing, amount and
form of future dividends, if any, will depend on our future results of operations and cash flow,
our capital requirements and surplus, the amount of distributions, if any, received by us from
our subsidiaries, our financial condition, contractual restrictions and other factors deemed
relevant by our board of directors. Currently, we do not have any dividend policy or intention
to declare or pay any dividends in the near future. As advised by our legal advisor as to Cayman
Islands law, notwithstanding that the Company may have accumulated losses, the Company
may declare dividend (a) out of profits of the Company if the Company has sufficient profits,
realized or unrealized, unless such is contrary to the accounting principles adopted by the
Company or (b) out of the share premium of the Company if following the date on which the
dividend is proposed to be paid, the Company is able to pay its debts as they fall due in the
ordinary course of business. In determining whether to declare a dividend, our Board will need
to be satisfied that the declaration of dividend is in the best interest of the Company and may
make provision for losses. Investors should not purchase our Shares with the expectation of
receiving cash dividends.
LISTING EXPENSES
Listing expenses to be borne by us are estimated to be approximately HK$120.3 million
(assuming an Offer Price of HK$98.90 per Share, being the mid-point of the indicative Offer
Price range of HK$94.60 to HK$103.20 per Share), representing approximately 8.1% of the
estimate gross proceeds from the Global Offering assuming no Shares are issued pursuant to
the Offer Size Adjustment Option and the Over-allotment Option. The listing expenses consist
of (i) underwriting-related expenses, including underwriting commission, of approximately
HK$67.1 million, and (ii) non-underwriting-related expenses of approximately HK$53.2
million, comprising (a) fees and expenses of our legal advisors and reporting accountants of
approximately HK$32.9 million, and (b) other fees and expenses of approximately HK$20.3
million. During the Track Record Period, listing expenses of RMB24.1 million (HK$26.5
million) was charged to our consolidated statements of profit or loss and RMB4.2 million
(HK$4.6 million) is expected to be accounted for as a deduction from equity upon the Listing.
After the Track Record Period, approximately HK$28.4 million is expected to be charged to
our consolidated statements of profit or loss, and approximately HK$60.8 million is expected
to be accounted for as a deduction from equity upon the Listing. The listing expenses above
are the latest practicable estimate for reference only, and the actual amount may differ from this
estimate.
UNAUDITED PRO FORMA FINANCIAL INFORMATION
The following unaudited pro forma statement of adjusted consolidated net tangible assets
of our Group prepared in accordance with Rule 4.29 of the Listing Rules is for illustrative
purposes only, and is set out below to illustrate the effect of the Global Offering on the net
tangible assets of our Group attributable to the owners of our Company as of December 31,
2024.
FINANCIAL INFORMATION
– 474 –


--- page 485 ---
This 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 give
a true picture of the consolidated net tangible assets of our Group as of December 31, 2024 or
at any future dates following the Global Offering.
Audited
consolidated
net tangible
liabilities of
our Group
attributable to
equity holders
of our
Company as of
December 31,
2024
Estimated net
proceeds
from the
Global
Offering
Estimated
Impact
Related
to the
Conversion of
the Preferred
Shares of our
Company
upon the
Completion
of the Global
Offering
Unaudited pro
forma adjusted
net tangible
liabilities
attributable to
equity holders
of our
Company as of
December 31,
2024
Unaudited pro forma
adjusted net tangible
liabilities per Share
RMB’000 RMB’000 RMB’000 RMB’000 RMB HK$
(Note 1) (Note 2) (Note 3) (Note 4) (Note 5)
Based on the Offer Price
of HK$94.60 per
Share /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(2,068,136) 1,231,440 3,046,784 2,210,088 26.57 28.79
Based on the Offer Price
of HK$103.20 per
Share /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(2,068,136) 1,345,647 3,046,784 2,324,295 27.94 30.28
Notes:
(1) The audited consolidated net tangible liabilities of our Group attributable to the owners of our Company
as of December 31, 2024 is extracted from the Accountant’s Report set out in Appendix I to this
prospectus, which is based on the unaudited consolidated net liabilities of our Group attributable to
equity holders of our Company as of December 31, 2024 of approximately RMB2,021,899,000, with an
adjustment for the intangible assets of approximately RMB46,237,000 as of December 31, 2024.
(2) The estimated net proceeds from the Global Offering are based on 15,071,600 Offer Shares expected to
be issued under the Global Offering and the indicative Offer Prices of HK$94.60 and HK$103.20 per
Offer Share, being the low and high end of the indicative price range, after deduction of the underwriting
fees and other related expenses (excluding listing expenses of RMB24,145,000 which have been
accounted for in the consolidated income statements prior to December 31, 2024) and takes no account
of any Ordinary Shares which may be allotted and issued by the Company pursuant to the exercise of
the Offer Size Adjustment Option and the Over-allotment Option or any Shares which may be issued by
the Company pursuant to the Pre-IPO Equity Incentive Plan, or any Shares which may be issued or
repurchased by the Company under the general mandates granted to our Directors as described in “Share
Capital”.
(3) Upon the completion of the Global Offering, all the convertible Preferred Shares of our Company will
be automatically converted into Ordinary Shares. These convertible Preferred Shares of our Company
will be re-designated from liabilities to equity. Accordingly, for the purpose of the unaudited pro forma
financial information, the unaudited pro forma adjusted consolidated net tangible assets attributable to
the owners of our Company will be increased by approximately RMB3,046,784,000 being the carrying
amount of the convertible Preferred Shares of our Company as of December 31, 2024.
FINANCIAL INFORMATION
– 475 –


--- page 486 ---
(4) The unaudited pro forma adjusted consolidated net tangible assets per Share is arrived at after the
adjustments referred to in the preceding paragraphs and on the basis that 83,175,764 Shares
(representing 8,000,000 Ordinary Shares and 60,104,164 Pre-IPO Preferred Shares as of December 31,
2024, and 15,071,600 Offer Shares to be issued upon the completion of the Global Offering) were in
issue, assuming that the Global Offering and the conversion of the convertible Preferred Shares of our
Company in note (3) had been completed on December 31, 2024 but does not take into account any
Ordinary 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 or any Shares which may be issued pursuant to
the Pre-IPO Equity Incentive Plan, or any Shares which may be issued or repurchased by our Company
under the general mandates granted to our Directors as described in “Share Capital”.
(5) For the purpose of the unaudited pro forma statement of adjusted consolidated net tangible assets, the
translation of Hong Kong dollars amounts into Renminbi was of rate of HK$1.00 to RMB0.9227, as set
out in the section headed “Information about this Prospectus and the Global Offering”. No
representation is made that Hong Kong dollar amounts have been, could have been or may be converted
to Renminbi, or vice versa, at that date.
(6) No adjustment has been made to the unaudited pro forma adjusted consolidated net tangible assets to
reflect any trading results or other transactions of our Group entered into subsequent to December 31,
2024.
NO MATERIAL ADVERSE CHANGE
After performing sufficient due diligence work which our Directors consider appropriate
and after due and careful consideration, our Directors confirm that, except as disclosed in
“Summary — Recent Developments and No Material Adverse Change” and up to the date of
this prospectus, there has been no material adverse change in our financial or trading position
or prospects since December 31, 2024, which is the end date of the periods reported on in the
Accountant’s Report included in Appendix I to this prospectus, and there is no event since
December 31, 2024 that would materially affect the information as set out in the Accountant’s
Report included 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, they were not aware of any
circumstance that would give rise to a disclosure requirement under Rules 13.13 to 13.19 of the
Listing Rules.
FINANCIAL INFORMATION
– 476 –


--- page 487 ---
AUTHORIZED AND ISSUED SHARE CAPITAL
The following is a description of the authorized share capital of our Company as of the
Latest Practicable Date and the issued share capital of our Company in issue and to be issued
as fully paid or credited as fully paid immediately after the Global Offering. All Preferred
Shares shall be automatically and immediately converted into Ordinary Shares on a one-to-one
basis upon Listing.
1. Share Capital as of the Latest Practicable Date
(i) Authorized Share Capital
Description of Shares
Number of
Shares
Approximate
aggregate
nominal value
of Shares
Approximate
percentage of
authorized
share capital
(US$) (%)
Ordinary Shares with a par value of
US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118139,895,836 13,989.58 69.95
Series Seed Preferred Shares with a par
value of US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,000,000 500.00 2.50
Series A-1 Preferred Shares with a par
value of US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111812,333,333 1,233.33 6.17
Series A-2 Preferred Shares with a par
value of US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,666,667 266.67 1.33
Series B-1 Preferred Shares with a par
value of US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816,666,666 1,666.67 8.33
Series B-2 Preferred Shares with a par
value of US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,437,498 2,343.75 11.72
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/H1118200,000,000 20,000 100.00
SHARE CAPITAL
– 477 –


--- page 488 ---
(ii) Issued Share Capital
Description of Shares
Number of
Shares
Approximate
aggregate
nominal value
of Shares
Approximate
percentage of
issued share
capital
(US$) (%)
Ordinary Shares with a par value of
US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,000,000 800.00 11.75
Series Seed Preferred Shares with a par
value of US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,000,000 500.00 7.34
Series A-1 Preferred Shares with a par
value of US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111812,333,333 1,233.33 18.11
Series A-2 Preferred Shares with a par
value of US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,666,667 266.67 3.92
Series B-1 Preferred Shares with a par
value of US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111816,666,666 1,666.67 24.47
Series B-2 Preferred Shares with a par
value of US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,437,498 2,343.75 34.41
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111868,104,164 6,810.42 100.00
2. Share capital immediately following the completion of the Global Offering (assuming
the Offer Size Adjustment Option and the Over-allotment Option are not exercised)
Authorized Share Capital
Description of Shares Number of Shares
Approximate
aggregate nominal
value of Shares
(US$)
Ordinary shares with a par value of
US$0.0001 each /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118200,000,000 20,000.000
Issued Share Capital
Description of Shares
Number of
Shares
Aggregate
nominal value
of Shares
Approximate
percentage of
issued share
capital
(US$) (%)
Shares in issue as of the Latest
Practicable Date /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111868,104,164 6,810.42 81.88
Shares to be issued pursuant to the
Global Offering /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815,071,600 1,507.16 18.12
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/H111883,175,764 8,317.58 100.00
SHARE CAPITAL
– 478 –


--- page 489 ---
ASSUMPTIONS
The above tables assume that the Global Offering becomes unconditional, that Shares are
issued pursuant to the Global Offering, and that the Preferred Shares are converted into Shares
on a one-to-one basis. The above tables do not take into account any additional Shares which
may be issued pursuant to the Pre-IPO Equity Incentive Plan, or any Shares which may be
issued or repurchased by the Company under the general mandates granted to our Directors as
referred to below.
RANKING
The Offer Shares are Shares in the share capital of our Company and rank equally in all
respects with all Shares currently in issue or to be issued (including all Preferred Shares to be
converted into Shares upon completion of the Global Offering) and, in particular, will rank
equally for all dividends or other distributions declared, made or paid on the Shares in respect
of a record date which falls after the date of this prospectus.
POTENTIAL CHANGES TO SHARE CAPITAL
Circumstances Under Which General Meetings and Class Meetings Are Required
Upon Listing, our Company will have only one class of shares, namely Ordinary Shares,
each of which ranks pari passu with the other Shares.
A company may, by an ordinary resolution of its members, if so authorized by its articles
of association, alter the conditions of its memorandum of association to (a) increase its share
capital by new shares of such amount as it thinks expedient provided that an exempted
company having no shares of a fixed amount may increase its share capital by such number of
shares without nominal or par value, or may increase the aggregate consideration for which
such shares may be issued, as it thinks expedient; (b) consolidate and divide all or any of its
share capital into shares of larger amount than its existing shares; (c) convert all or any of its
paid-up shares into stock, and reconvert that stock into paid-up shares of any denomination; (d)
subdivide its shares or any of them, into shares of an amount smaller than that fixed by the
memorandum of association so, however, that in the subdivision the proportion between the
amount paid and the amount, if any, unpaid on each reduced share shall be the same as it was
in case of the share from which the reduced share is derived; and (e) cancel shares which, at
the date of the passing of the resolution in that behalf, have not been taken or agreed to be taken
by any person, and diminish the amount of its share capital by the amount of the shares so
cancelled or, in the case of shares without nominal or par value, diminish the number of shares
into which its capital is divided. Subject to the provisions of the Companies Act and to
confirmation by the Cayman Islands Court, a company limited by shares may, if so authorized
by its articles of association, by special resolution, reduce its share capital in any way. Please
see “Summary of the Constitution of our Company and Cayman Islands Company Law” in
Appendix III to this prospectus for details.
SHARE CAPITAL
– 479 –


--- page 490 ---
As a matter of the Companies Act, an exempted company is not required by law to hold
any general meetings or class meetings. The holding of general meetings or class meetings is
prescribed for under the Articles of Association. Accordingly, our Company will hold general
meetings and class meetings as prescribed for under the Articles of Association, a summary of
which is set forth in the section headed “Summary of the Constitution of our Company and
Cayman Islands Company Law” in Appendix III to this prospectus.
General Mandate to Issue Shares
Subject to the Global Offering becoming unconditional, our Directors have been granted
a general mandate to allot, issue and deal with (including the sale or transfer of Treasury
Shares) any Shares or securities convertible into Shares of not more than the sum of:
(a) 20% of the total number of Shares in issue (excluding Treasury Shares) immediately
following completion of the Global Offering (but excluding any Shares which may
be issued pursuant to the exercise of the Offer Size Adjustment Option and the
Over-allotment Option); and
(b) the total number of Shares repurchased by our Company pursuant to the authority
referred to in “— General Mandate to Repurchase Shares” below.
This general mandate to issue Shares will remain in effect until the earliest of:
(a) the conclusion of the next annual general meeting of our Company unless, by
ordinary resolution passed at that meeting, the authority is renewed, either
unconditionally or subject to condition;
(b) the expiration of the period within which the next annual general meeting of our
Company is required to be held under any applicable laws of the Cayman Islands or
the Memorandum and Articles of Association; and
(c) the passing of an ordinary resolution by Shareholders in a general meeting revoking
or varying the authority.
SHARE CAPITAL
– 480 –


--- page 491 ---
General Mandate to Repurchase Shares
Subject to the Global Offering becoming unconditional, our Directors have been granted
a general mandate to repurchase our own Shares up to 10% of the total number of Shares in
issue (excluding Treasury Shares) immediately following completion of the Global Offering
(excluding any Shares which may be allotted and issued pursuant to the exercise of the Offer
Size Adjustment Option and the Over-allotment Option, if any).
This repurchase mandate only relates to repurchases on the Stock Exchange or on any
other stock exchange on which the securities of our Company may be listed and which is
recognized by the SFC and the Stock Exchange for this purpose, and in accordance with all
applicable laws and the requirements under the Listing Rules or equivalent rules or regulations
of any other stock exchange as amended from time to time.
This general mandate to repurchase Shares will remain in effect until the earliest of:
(a) the conclusion of the next annual general meeting of our Company unless, by
ordinary resolution passed at that meeting, the authority is renewed, either
unconditionally or subject to condition;
(b) the expiration of the period within which the next annual general meeting of our
Company is required to be held under any applicable laws of the Cayman Islands or
the Memorandum and Articles of Association; and
(c) the passing of an ordinary resolution by our Shareholders in a general meeting
revoking or varying the authority.
See “Statutory and General Information — A. Further Information about Our Company
— 4. Resolutions of Shareholders of Our Company Passed on April 1, 2025” in Appendix IV
for further details of the general mandate to issue and repurchase Shares.
SHARE INCENTIVE SCHEME
As of the Latest Practicable Date, we had one share incentive scheme, namely the Pre-IPO
Equity Incentive Plan, the terms of which are not subject to the provisions of Chapter 17 of the
Listing Rules. For further details of the Pre-IPO Equity Incentive Plan, please see “Statutory
and General Information — D. Share Incentive Plan — Pre-IPO Equity Incentive Plan” in
Appendix IV to this prospectus.
SHARE CAPITAL
– 481 –


--- page 492 ---
So far as is known to our Directors, immediately after the Global Offering, assuming the
Offer Size Adjustment Option and the Over-allotment Option are not exercised, the following
persons are expected to have an interest and/or short positions in our Shares or underlying
Shares of our Company which would fall to be disclosed to us pursuant to the provisions of
Divisions 2 and 3 of Part XV of the SFO, or, who are, directly or indirectly, is entitled to
exercise, or control the exercise of, 10% or more of the voting power at any meeting of our
Company or any other member of our Group:
Shares held as of the Latest
Practicable Date
Shares held immediately
after the Global Offering
(assuming the Offer Size
Adjustment Option and the
Over-allotment Option are
not exercised)
Name
Nature of
interest
Number of
Shares (1)
Approximate
percentage of
interest in
our
Company
Number of
Shares (1)
Approximate
percentage of
interest in
our
Company
LA V Fund VI, L.P .
(“LA V Fund VI ”)(2) /H1118/H1118/H1118
Beneficial
owner
11,272,321 16.55% 11,272,321 13.55%
LA V Fund VI
Opportunities, L.P .
(“LA V Opportunities ”) /H1118
Beneficial
owner
5,000,000
(3) 7.34% 5,000,000 6.01%
Interest in a
controlled
corporation
– – 393,100
(4) 0.47%
King Star Med LP
(“King Star Med ”)(5) /H1118/H1118
Beneficial
owner
6,589,554 9.68% 6,589,554 7.92%
Founder Holdco (6) /H1118/H1118/H1118/H1118/H1118/H1118Beneficial
owner
6,500,000 9.54% 6,500,000 7.81%
Interest of a
party to an
agreement
2,000,000
(3) 2.94% – –
Shanghai Yingjia
Enterprise Management
Partnership (Limited
Partnership) ( ɪऎๅТΆ
ุ၍ଣΥྫΆุ(Υ
ྫ)) (“ Shanghai
Yingjia ”)
(7) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Beneficial
owner
6,387,649 9.38% 6,387,649 7.68%
WuXi Biologics
HealthCare V enture
(“WuXi Venture ”)
(8) /H1118/H1118/H1118
Beneficial
owner
4,169,643 6.12% 4,169,643 5.01%
SUBSTANTIAL SHAREHOLDERS
– 482 –


--- page 493 ---
Notes:
(1) All interests stated are long positions.
(2) LA V Fund VI is a Cayman Islands exempted limited partnership whose general partner is LA V GP VI,
L.P . The general partner of LA V GP VI, L.P . is LA V Corporate VI GP , Ltd., a Cayman Islands exempted
company wholly owned by Dr. SHI Yi. Therefore, under the SFO, each of LA V GP VI, L.P ., LA V
Corporate VI GP , Ltd. and Dr. SHI Yi is deemed to be interested in the Shares held by LA V Fund VI.
LA V Opportunities is a Cayman Islands exempted limited partnership whose general partner is LA V GP
VI Opportunities, L.P . The general partner of LA V GP VI Opportunities, L.P . is LA V Corporate VI GP
Opportunities, Ltd., a Cayman Islands exempted company wholly owned by Dr. SHI Yi. Therefore,
under the SFO, each of LA V GP VI Opportunities, L.P ., LA V Corporate VI GP , Ltd. and Dr. SHI Yi is
deemed to be interested in the Shares held by LA V Opportunities.
For details of LA V Fund VI and LA V Opportunities, see “History and Corporate Structure — Pre-IPO
Investments — Information regarding the Pre-IPO Investors.”
(3) Founder Holdco is entitled to exercise the voting rights attached to 2,000,000 Ordinary Shares held by
LA V Opportunities pursuant to the V oting Rights Proxy Agreement, which will terminate upon
completion of the Global Offering. For details, see “History and Corporate Structure — V oting Rights
Proxy Agreement”.
(4) The shareholding represents the Offer Shares (calculated based on the Offer Price of HK$98.90, being
the midpoint of the indicative Offer Price range) to be subscribed by LA V Star Opportunities Limited,
a wholly owned subsidiary of LA V Opportunities, as a cornerstone investor. For details, see
“Cornerstone Investors”. Therefore, under the SFO, each of LA V Opportunities, LA V GP VI
Opportunities, L.P ., LA V Corporate VI GP , Ltd. and Dr. SHI Yi is deemed to be interested in the Shares
held by LA V Star Opportunities Limited.
(5) King Star Med is a Cayman Islands exempted limited partnership. The general partner and manager of
King Star Med, namely King Star Med Management Limited and King Star Consulting Limited are both
indirectly held by Ace Treasure Trust and Superb Outcome Trust (the “ Trusts ”) as to 40.0% and 30.0%,
respectively. Dr. LIN Xianghong is the settlor, the protector and one of the beneficiaries of the Trusts.
Therefore, under the SFO, Dr. LIN Xianghong, the Trusts, King Star Consulting Limited and King Star
Med Management Limited is deemed to be interested in the Shares held by King Star Med. For details
of King Star Med, see “History and Corporate Structure — Pre-IPO Investments — Information
regarding the Pre-IPO Investors.”
(6) Founder Holdco is a company with limited liability incorporated under the laws of BVI and is wholly
owned by our founder, Dr. ZHU Zhongyuan. Therefore, under the SFO, Dr. ZHU is deemed to be
interested in the Shares held by Founder Holdco.
(7) Shanghai Yingjia is a limited partnership incorporated in the PRC whose general partner is Xiamen
Yinglian Health Industry Management Partnership (Limited Partnership) (ๅᑌ਄ੰପุ၍ଣΥྫ
Άุ(Υྫ)) (“ Yinglian Management ”). Yinglian Management is controlled by Xiamen Yinglian
Health Industry Investment Management Co. (ʮ̡)( “ Yinglian
Health ”), which is ultimately beneficially owned by LUO Jing. Therefore, under the SFO, each of
Yinglian Management, Yinglian Health and LUO Jing is deemed to be interested in the Shares held by
Shanghai Yingjia. For details of Shanghai Yingjia, see “History and Corporate Structure — Pre-IPO
Investments — Information regarding the Pre-IPO Investors.”
(8) WuXi V enture is a limited liability partnership incorporated in Hong Kong, which is wholly owned and
ultimately controlled by WuXi Biologics (Cayman) Inc., a company listed on the Stock Exchange (stock
code: 2269). Therefore, under the SFO, WuXi Biologics (Cayman) Inc. is deemed to be interested in the
Shares held by WuXi V enture. For details of WuXi V enture, see “History and Corporate Structure —
Pre-IPO Investments — Information regarding the Pre-IPO Investors.”
Except as disclosed above, our Directors are not aware of any persons who will,
immediately following completion of the Global Offering (assuming that the Offer Size
Adjustment Option and the Over-allotment Option are not exercised), have any interests and/or
short positions in the Shares or underlying Shares of our Company which would fall to be
disclosed to the Company and the Stock Exchange under the provisions of Divisions 2 and 3
of Part XV of the SFO or, will be, directly or indirectly, is entitled to exercise, or control the
exercise of, 10% or more of the voting power at any meeting of our Company or any other
member of our Group.
SUBSTANTIAL SHAREHOLDERS
– 483 –


--- page 494 ---
BOARD OF DIRECTORS
Our Board consists of eight Directors, comprising three executive Directors, two
non-executive Directors and three independent non-executive Directors. The following table
sets forth the key information about our Directors as of the Latest Practicable Date.
Name Age Positions
Roles and
responsibilities
Date of
joining our
Group
Date of
appointment
as a Director
Dr. ZHU
Zhongyuan
(Ⴣ) /H1118/H1118/H1118/H1118
54 Chairman of the
Board, executive
Director and chief
executive officer
Responsible for
strategic vision,
corporate
management and
business planning of
our Group
January 1,
2020
February 19,
2020
Mr. ZHANG
Shaoren
(ੵჭˁ) /H1118/H1118/H1118/H1118
39 Executive Director
and vice president
of finance
Responsible for the
overall financial
strategy, corporate
finance and capital
management of our
Group
May 1, 2020 April 23,
2021
Ms. SI Wen
(̡˖) /H1118/H1118/H1118/H1118/H1118/H1118
45 Executive Director
and executive
director ( ੂБᐼ္)
of human resources
Responsible for the
management of
human resources
affairs of our Group
October 21,
2020
April 23,
2021
Mr. CAI Zhiyang
(
ݱH1118/H1118/H1118/H1118
43 Non-executive
Director
Responsible for
overseeing Board
affairs and providing
strategic advice and
guidance on the
business operations
of our Group
July 22,
2024
July 22,
2024
Dr. YU Tao
(Яᏹ) /H1118/H1118/H1118/H1118/H1118/H1118
39 Non-executive
Director
Responsible for
overseeing Board
affairs and providing
strategic advice and
guidance on the
business operations
of our Group
April 23,
2021
April 23,
2021
DIRECTORS AND SENIOR MANAGEMENT
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--- page 495 ---
Name Age Positions
Roles and
responsibilities
Date of
joining our
Group
Date of
appointment
as a Director
Mr. XIE Dong
(؇)Note) /H1118/H1118/H1118
44 Independent
non-executive
Director
Responsible for
providing
independent advice
and judgment to our
Board
August 12,
2024
August 12,
2024
Mr. GAO
Fengyong
(ۇ)
Note) /H1118
54 Independent
non-executive
Director
Responsible for
providing
independent advice
and judgment to our
Board
August 12,
2024
August 12,
2024
Ms. CHUAI
Shuyin
(ౣ᪣ত)
(Note) /H1118
48 Independent
non-executive
Director
Responsible for
providing
independent advice
and judgment to our
Board
August 12,
2024
August 12,
2024
Note: Mr. XIE Dong (؇Mr. GAO Fengyong (ۇand Ms. CHUAI Shuyin ( ౣ᪣ত) have been appointed by
the Board as our independent non-executive Directors, effective from the Listing Date.
Executive Directors
Dr. ZHU Zhongyuan (Ⴣ), aged 54, is our founder, chairman of the Board, executive
Director and chief executive officer of our Company. He also holds directorships and
managerial positions across our subsidiaries. Dr. ZHU was re-designated as our executive
Director on August 12, 2024. He is primarily responsible for strategic vision, corporate
management and business planning of our Group.
Dr. ZHU is a sophisticated and resourceful veteran in China’s biotech industry with strong
scientific and business acumen. He brings in over 20 years of experience bridging the realms
of biotech entrepreneurship and venture investment. Dr. ZHU has been instrumental in
investing in and incubating a number of notable emerging biotech companies, including CStone
Pharmaceuticals (2616.HK), RemeGen (9995.HK), Gan & Lee Pharmaceuticals (603087. SH),
and BGI Genomics (300676. SH). Throughout his career, Dr. ZHU has focused on value
creation, and has established a reputation of driving growth and innovation, navigating market
dynamics while managing operational risks. He developed company building acumen at two
leading biotech venture investment firms, including 6 Dimensions Capital, where he served as
a Partner from 2018 to 2019, and Wuxi Healthcare V entures, where he also held the position
of Partner from 2015 to 2017. Prior to these roles, Dr. ZHU held various senior roles at
Mingxin Capital, SIG Asia Investment Fund, Greenwoods Investment and HighLight Capital,
from 2008 to 2015.
DIRECTORS AND SENIOR MANAGEMENT
– 485 –


--- page 496 ---
In addition, Dr. ZHU held multiple non-executive directorships at various portfolio
companies, including a non-executive director of Phoenix Healthcare Group Co., Ltd.
(currently known as China Resources Medical Holdings Company Limited (1515. HK)), from
September 2013 to July 2014, and a non-executive director of CStone Pharmaceuticals (2616.
HK), from April 2016 to August 2018. In 2006, he was the senior director at Shanghai
Genomics, Inc. (ʮ̡), which was later acquired by GNI Group Ltd, an
integrated multinational biopharma.
Dr. ZHU obtained a bachelor’s degree in molecular biology from Nankai University (ی
කɽኪ) in the PRC in July 1992, a Ph.D. in biomedical science from the University of
Massachusetts at Worcester in the United States in June 2001, and an MBA from the University
of California at Berkeley in the United States in December 2005. In July 2020, Dr. ZHU was
honored with “14th Jinji Lake Leading Scientific Talent of Suzhou Industrial Park” ( ᘽψʈุ
ɛʑ) by the Suzhou Industrial Park Administrative Committee
(ᘽψʈุ෤ਜ၍։ึ).
Mr. ZHANG Shaoren ( ੵჭˁ), aged 39, is our executive Director and vice president of
finance. Mr. ZHANG has been our Director since April 23, 2021, and re-designated as our
executive Director on August 12, 2024. He is primarily responsible for the overall financial
strategy, corporate finance and capital management of our Group. Mr. ZHANG served as
various senior positions within our Group previously, including a director ( ᐼ္) from May
2020 to July 2021, and an executive director ( ੂБᐼ္) from August 2021 to February 2024.
Mr. ZHANG’s extensive financial management, strategic investment, and financing
experience spans over 15 years. He honed his expertise during his tenure as manager at
PricewaterhouseCoopers Zhong Tian LLP (ה(౷ஷΥྫ)) from
September 2008 to November 2015, with his last position as manager at the audit department
where he was primarily responsible for providing audit services to multiple clients. From
December 2015 to June 2017, Mr. ZHANG served as the deputy general manager for Shanghai
Yikang Medical Laboratory Co., Ltd. (ʮ̡), a company dedicated to
the R&D of single-cell whole genome amplification and sequencing technology for the field of
eugenics and early cancer diagnosis, responsible for overseeing financial and operational
management. From February 2017 to December 2019, Mr. ZHANG served as the deputy
general manager of Shanghai Shihao International Logistics Co., Ltd. (ࠢ
ʮ̡), a logistics service company and an affiliate of Y .U.D. Y angtze River Investment Industry
Co., Ltd. (ʮ̡), a comprehensive logistics company listed on
Shanghai Stock Exchange (stock code: 600119), where he was responsible for the company’s
overall operations.
Mr. ZHANG obtained a bachelor’s degree in international accounting from Shanghai
Institute of Foreign Trade (ኪ৫) (currently known as Shanghai University of
International Business and Economics ( ɪऎ࿁̮຾൱ɽኪ)) in July 2008, and a Finance MBA
from China Europe International Business School ( ʕᆄ਷ყʈਠኪ৫) in November 2022,
both in the PRC. He was accredited as a non-practicing Certified Public Accountant by
Shanghai Institute of Certified Public Accountants (՘ึ) in December
2015.
DIRECTORS AND SENIOR MANAGEMENT
– 486 –


--- page 497 ---
Ms. SI Wen ( ̡˖), aged 45, is our executive Director and executive director ( ੂБᐼ္)
of human resources. Ms. SI first joined our Group as director of human resources in October
2020. She has been our Director since April 23, 2021 and was re-designated as our executive
Director on August 12, 2024. Ms. SI is primarily responsible for the management of human
resources affairs of our Group.
Ms. SI’s career demonstrates a consistent dedication to human resources expertise. With
over 20 years of industry experience spanning diverse sectors, including, among others,
pharmacology, chemicals, and healthcare, she has established herself as a human resources
trailblazer. Ms. SI began her career honing her operational expertise at Kentucky Fried Chicken
(Guangdong) Co., Ltd. (ʮ̡) (currently known as Y um! Restaurants
(Guangdong) Co., Ltd. ( ϵ௷᎛භ(؇)ʮ̡)), an affiliate of Y um China Holdings, Inc.
(ʮ̡), a restaurant company listed on both the Stock Exchange (stock code:
9987) and the New Y ork Stock Exchange (ticker symbol: YUMC), from January 2002 to
November 2002.
Prior to joining our Group, Ms. SI served as various positions in several companies,
including but not limited to:
 at Wrigley Confectionery (China) Limited (؈(ʕ਷)ʮ̡) (currently
known as Mars Wrigley Confectionery (China) Limited (؈(ʕ਷)ʮ
̡)), from December 2002 to April 2006;
 at the China-based subsidiaries of Novartis AG, a medicines company listed on both
the New Y ork Stock Exchange (ticker symbol: NVS) and the SIX Swiss Exchange
(ticker symbol: NOVN), from January 2009 to November 2011;
 at Tecan (Shanghai) Trading Co., Ltd. (ٵ܎(ɪऎ)ʮ̡) (currently known
as Tecan (Shanghai) Laboratory Equipment Co., Ltd. (ٵ܎(ɪऎ)ʮ
̡)), an associate of Tecan Group AG, a healthcare company listed on the SIX Swiss
Exchange (ticker symbol: TECN), from December 2011 to November 2013, and
from August 2014 to December 2018, respectively, being, among others, its director
of human resources;
 at Dow Chemical (China) Investment Company Limited ( ௗˤʷኪ(ʕ਷)ࠢ
ʮ̡), an associate of Dow Inc., a global materials science company listed on the
New Y ork Stock Exchange (ticker symbol: DOW), from November 2013 to August
2014; and
 at Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (ᔼᖹ
ʮ̡), a wholly-owned subsidiary Shanghai Fosun Pharmaceutical
(Group) Co., Ltd. (ᔼᖹ(ණྠ)ʮ̡), a pharmaceutical
manufacturing company listed on both the Stock Exchange (stock code: 2196) and
Shanghai Stock Exchange (stock code: 600196), from December 2018 to October
2020, being its senior director of human resources.
DIRECTORS AND SENIOR MANAGEMENT
– 487 –


--- page 498 ---
Ms. SI obtained a bachelor’s degree in economics from Southwest University of Science
and Technology (Ҧɽኪ) in the PRC in June 2001, and a postgraduate diploma in
managerial psychology from the Institute for China Business, School of Professional and
Continuing Education of the University of Hong Kong in November 2023.
Non-executive Directors
Mr. CAI Zhiyang (ݱ)aged 43, has been appointed as a Director on July 22, 2024
and re-designated as our non-executive Director on August 12, 2024. He is mainly responsible
for overseeing Board affairs and providing strategic advice and guidance on the business
operations of our Group.
For more than ten years, Mr. CAI has been focusing on the private equity and M&A
practices, spearheading investment sourcing, management, consulting and execution. He is the
partner of Suzhou Qingtan Private Fund Management Partnership (Limited Partnership) ( ᘽψ
၍ଣΥྫΆุ(Υྫ)), since January 2023. From April 2012 to July 2016, he
served at Fountain Investment Consulting (Shanghai) Co., Ltd. ( ˙๕ҳ༟ᚥਪ(ɪऎ)ʮ̡)
with his last position as the vice president of investment, primarily responsible for the
evaluation and post-investment management of investment projects. Subsequently, from March
2017 to December 2022, he was a partner at Suzhou Kington Capital Co., Ltd. (ᛆ
ʮ̡).
Mr. CAI obtained a bachelor’s degree in economics from Fudan University ( ూ͇ɽኪ)i n
the PRC in July 2004 and an MBA from the Wharton School of the University of Pennsylvania
in the United States in May 2009.
Dr. YU Tao ( Яᏹ), aged 39, has been our Director since April 23, 2021 and re-designated
as our non-executive Director on August 12, 2024. He is mainly responsible for overseeing
Board affairs and providing strategic advice and guidance on the business operations of our
Group.
Dr. YU has nearly a decade of professional experience in investment management, with
a specialized focus on the biotechnology sector for over seven years. He has been serving as
managing director at Lilly Asia V entures, a biomedical venture capital firm focused on
healthcare investment, since February 2025, where he started in March 2018 and served as
principal before February 2025. Dr. YU’s early career, from July 2015 to February 2018, was
with McKinsey & Company, where he served as an engagement manager as his last position.
Dr. YU obtained a bachelor’s degree in biological science from Peking University ( ̏ԯ
ɽኪ) in the PRC in July 2008 and a Ph.D. in biomedical engineering from Johns Hopkins
University in the United States in May 2015.
DIRECTORS AND SENIOR MANAGEMENT
– 488 –


--- page 499 ---
Independent Non-executive Directors
Mr. XIE Dong (؇)aged 44, has been appointed as an independent non-executive
Director with effect from the Listing. He is mainly responsible for providing independent
advice and judgment to our Board.
Mr. XIE has nearly 19 years of professional experience in sectors of financial
management, auditing, investment and financing, and capital markets. He has served as the (i)
chief financial officer and director of QuantaSing Group Limited, a Chinese leading online
service provider listed on the Nasdaq (ticker symbol: QSG), since January 2021 and June 2022,
respectively; and (ii) independent non-executive director of China BlueChemical Ltd. ( ʕऎͩ
ʮ̡), a state-owned chemical fertilizer producer and leading methanol
producer listed on the Stock Exchange (stock code: 3983), since May 2021.
Prior to the above positions, from October 2006 to October 2007, Mr. XIE worked as a
staff accountant of the auditing department of Ernst & Y oung Hua Ming LLP (ࠇ
ה(౷ஷΥྫ)). From April 2010 to September 2010, he was appointed as vice
president of CCB International (China) Limited (ვ਷ყ(ʕ਷)ʮ̡). From October
2010 to August 2014, he served as associate director at Deloitte China. From September 2014
to December 2018, he served as the chief financial officer and company secretary of FinUp
Finance Technology Group (Holding) Limited. From January 2019 to March 2020, he served
as the director and chief financial officer of Renmai Technology Group (Holding) Limited ( ΂
Ҧණྠ(ٰ)ʮ̡).
Mr. XIE obtained a bachelor’s degree in economics and a master’s degree in world
economics from Nankai University in June 2003 and June 2006, respectively. He is a holder
of Chinese Institute of Certified Public Accountants (CICPA), Certified Internal Auditor (CIA),
Certified Tax Agent (CTA) and Chinese Legal Professional Qualification.
Mr. GAO Fengyong (ۇ)aged 54, has been appointed as an independent
non-executive Director with effect from the Listing. He is mainly responsible for providing
independent advice and judgment to our Board.
Since the nineties, Mr. GAO has been engaged in investment and financing activities.
Concurrently outside our Group, Mr. GAO is (i) the founder and director of Shanghai Leading
Investment Management Co., Ltd. (ʮ̡) since July 2007, (ii) the
founder, partner and chairman of the board of Shanghai Blue Ocean Capital Co., Ltd. ( ɪऎᝒ
ʮ̡) since September 2012, and (iii) a supervisor of Wuhan Guide
Technology Co., Ltd. (ʮ̡), a company specializing in development,
production and sales in industrial automation, since January 2022. In his early career, Mr. GAO
worked at Southern Securities Co., Ltd. (ʮ̡), engaged in underwriting and
sponsorship activities, and Bridge Trust Co., Ltd. (ப΂ʮ̡), an affiliate of
SPIC Industry-Finance Holdings Co., Ltd. (ʮ̡), a company
listed on Shenzhen Stock Exchange (stock code: 000958), with his last position being vice
president.
DIRECTORS AND SENIOR MANAGEMENT
– 489 –


--- page 500 ---
Mr. GAO has been holding and held directorships or supervisory roles in the following
listed companies:
 a director of Henan BCCY Environmental Energy Co., Ltd (ঐ๕
ʮ̡), an environmentally-focused technology enterprise listed on
Shenzhen Stock Exchange (stock code: 300614), since January 2016;
 an independent director of CNFinance Holdings Limited, a leading home equity loan
service provider listed on both the New Y ork Stock Exchange (ticker symbol: CNF),
since November 2018;
 an independent director of Nanjing Xinjiekou Department Store Co., Ltd. (ԯอ൑
ʮ̡), a company listed on Shanghai Stock Exchange (stock
code: 600682), since December 2019;
 a supervisor of Shaanxi Construction Machinery Co., Ltd. (ࠢ
ʮ̡), a company listed on Shanghai Stock Exchange (stock code: 600984), from
October 2015 to November 2017;
 an independent director of China Haisum Engineering Co., Ltd. (Ҧ
ʮ̡), a comprehensive engineering service company listed on Shenzhen
Stock Exchange (stock code: 002116), from August 2016 to May 2023; and
 an independent director of Great Wall Movie and Television Co., Ltd. (ٰ
ʮ̡), a company previously listed on Shenzhen Stock Exchange (stock code:
002071) and delisted in May 2021, from February 2017 to April 2020.
Mr. GAO obtained both his bachelor’s degree and master’s degree in finance from Nankai
University in July 1992 and January 2002, respectively.
Ms. CHUAI Shuyin ( ౣ᪣ত), aged 48, has been appointed as an independent
non-executive Director with effect from the Listing. She is mainly responsible for providing
independent advice and judgment to our Board.
Ms. CHUAI is the founder of Shanghai Meishen Enterprise Management Consulting Co.,
Ltd. (ʮ̡), also known as Mission Consulting ( Դնፔ༔), acting
as its executive director. From January 2007 to May 2008, she was employed by the Shanghai
branch of Zhirui Enterprise Consulting (Shenzhen) Co., Ltd. ( ౽ြΆุፔ༔(ଉέ)ʮ̡)
(currently known as Zhirui Zhuocai Enterprise Consulting (Shanghai) Co., Ltd. ( ౽ြՙʑΆุ
ፔ༔(ɪऎ)ʮ̡)). From May 2008 to December 2008, she was recruited by Hewitt
Consulting (Shanghai) Co., Ltd. (currently known as Aon Enterprise Services (Shanghai) Co.,
Ltd. (ਕ(ɪऎ)ʮ̡)). From March 2009 to April 2010, she worked for
Shanghai Maizhi Enterprise Management Consulting Office (ה.)
Later from December 2011 to March 2020, she was employed by McKinsey & Consulting
Company Inc., Shanghai (፼(ɪऎ)ʮ̡).
DIRECTORS AND SENIOR MANAGEMENT
– 490 –


--- page 501 ---
Ms. CHUAI obtained a bachelor’s degree in Korean language and culture and a master’s
degree in Asian and African languages and literatures from Peking University in July 1998 and
June 2001, respectively. She also obtained a master’s degree in art and in human resources and
industrial relations from the University of Illinois at Urbana-Champaign in the United States
in May 2003 and December 2004, respectively. She is now the honorary president of the
Shanghai Alumni Chapter of the University of Illinois Urbana-Champaign.
SENIOR MANAGEMENT
Our senior management is responsible for the day-to-day management of our business.
The following table sets forth the key information about our senior management as of the
Latest Practicable Date.
Name Age Positions
Roles and
responsibilities
Date of
joining our
Group
Date of
appointment
as a senior
management
Dr. ZHU
Zhongyuan
(Ⴣ) /H1118/H1118/H1118/H1118
54 Chairman of the
Board, executive
Director and chief
executive officer
Responsible for
strategic vision,
corporate
management and
business planning of
our Group
January 1,
2020
January 1,
2020
Mr. ZHANG
Shaoren
(ੵჭˁ) /H1118/H1118/H1118/H1118
39 Executive Director
and vice president
of finance
Responsible for the
overall financial
strategy, corporate
finance, capital
management and
investor relations of
our Group
May 1, 2020 April 23,
2021
Ms. SI Wen
(̡˖) /H1118/H1118/H1118/H1118/H1118/H1118
45 Executive Director
and executive
director ( ੂБᐼ္)
of human resources
Responsible for the
management of
human resources
affairs of our Group
October 16,
2020
April 23,
2021
Dr. QIU Y ang
(เ) /H1118/H1118/H1118/H1118/H1118/H1118
52 Chief scientific
officer
Responsible for
directing the R&D,
providing scientific
insights and
leadership, and
progressing key
assets of our Group
July 19,
2021
July 19,
2021
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Name Age Positions
Roles and
responsibilities
Date of
joining our
Group
Date of
appointment
as a senior
management
Dr. MU Hua
(ϳ㏞) /H1118/H1118/H1118/H1118/H1118/H1118
61 Global chief medical
officer
Responsible for leading
global clinical
development team
and developing
clinical development
strategies of our
Group
March 24,
2025
March 24,
2025
Ms. GU Wei
(ᚥᑢ) /H1118/H1118/H1118/H1118/H1118/H1118
53 Chief medical officer Responsible for leading
clinical development
team and developing
clinical development
strategies of our
Group
July 18,
2022
July 18,
2022
Mr. W ANG Xin
(׿)H1118/H1118/H1118/H1118/H1118/H1118
53 Chief business officer Responsible for the
business
development, external
cooperation and
licensing strategies of
our Group
June 27,
2022
June 27,
2022
Dr. HUA
Haiqing
(ऎ૶) /H1118/H1118/H1118/H1118
44 Senior vice president
and head of drug
discovery
Responsible for the
pipeline development
strategies, new drug
discovery and R&D
of our Group
July 1, 2021 July 1, 2021
Mr. YU Xin
(ɲ㒥) /H1118/H1118/H1118/H1118/H1118/H1118
42 Vice president and
head of regulatory
affairs
Responsible for
overseeing regulatory
affairs and product
registration
operations of our
Group
August 1,
2021
August 1,
2021
Dr. SHI Rong
(࿰) /H1118/H1118/H1118/H1118/H1118/H1118
43 Vice president of
development
science
Responsible for leading
team of clinical
pharmacologists and
bioanalysis of our
Group
February 24,
2022
February 24,
2022
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Name Age Positions
Roles and
responsibilities
Date of
joining our
Group
Date of
appointment
as a senior
management
Dr. CHU Ruiyin
(Ꮇ๿ვ) /H1118/H1118/H1118/H1118
63 Vice president of
translational
medicine
Responsible for
management of the
translational medicine
department of our
Group
July 24,
2023
July 24,
2023
Ms. ZHOU Lan
(մళ) /H1118/H1118/H1118/H1118/H1118/H1118
54 Vice president of
commercial
strategy
Responsible for the
product
commercialization
strategy and
government
relationship of our
Group
May 1, 2024 May 1, 2024
Dr. ZHU Zhongyuan (Ⴣ), aged 54, is our chief executive officer. For his biography,
see “— Board of Directors — Executive Directors” in this section.
Mr. ZHANG Shaoren ( ੵჭˁ), aged 39, is our vice president of finance. For his
biography, see “— Board of Directors — Executive Directors” in this section.
Ms. SI Wen ( ̡˖), aged 45, is our executive director ( ੂБᐼ္) of human resources. For
her biography, see “— Board of Directors — Executive Directors” in this section.
Dr. QIU Y ang (เ), aged 52, first joined our Group as senior vice president of
translational medicine in July 2021 and was then promoted to our chief scientific officer in
March 2022. Dr. QIU is also the general manager of Duality U.S. She is mainly responsible for
directing the R&D, providing scientific insights and leadership, and progressing key assets of
our Group.
Dr. QIU brings over 20 years of global leadership experience in the biopharmaceutical
industry, with a demonstrated track record of success in drug discovery, translational medicine
and early clinical development. Prior to joining our Group, from March 2004 to December
2015, Dr. QIU worked at the China-based subsidiaries of GlaxoSmithKline plc., a global
healthcare company listed on both the London Stock Exchange (stock code: GSK) and the New
Y ork Stock Exchange (ticker symbol: GSK), with her last position being a director, leading the
progress of early drug discovery. From April 2016 to May 2019, Dr. QIU joined Johnson &
Johnson (China) Investment Ltd. ( ੶͛(ʕ਷)ʮ̡), a subsidiary of Johnson &
Johnson, whose shares are listed on the New Y ork Stock Exchange (ticker symbol: JNJ).
During her tenure, she worked at the division Janssen (China) Research & Development Center
(เಌ(ʕ਷)೯ʕː) as its director of biomarker research, where she was responsible for the
DIRECTORS AND SENIOR MANAGEMENT
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design and delivery of multiple biomarker studies in clinical development programs of the
company’s oncology portfolio. From May 2019 to July 2021, Dr. QIU served at a
pharmaceutical company Daiichi Sankyo Inc., an affiliate of Daiichi Sankyo Company,
Limited, which is listed on Tokyo Stock Exchange (stock code: 4568), where she was
responsible for the development of global translational medicine and early development
strategy for ADC programs.
Dr. QIU obtained a master’s degree and a Ph.D. from University of Texas at Austin in the
United States in December 1994 and December 1997, respectively.
Dr. MU Hua ( ϳ㏞), aged 61, is our global chief medical officer. He is mainly responsible
for leading global clinical development team and developing clinical development strategies of
our Group.
Dr. MU is a seasoned biotechnology executive and drug developer with decades of global
experience in pharmaceutical research, translational medicine and clinical development. He
assumed leadership roles across multinational corporations, biopharmaceutical enterprises and
investment firm, including, among others, (i) the director of medical research at Biogen Idec,
a biotechnology company listed on NASDAQ (ticker symbol: BIIB), from May 2006 to April
2008; (ii) the medical director at Genentech, Inc. from May 2008 to April 2010; (iii)
successively the senior vice president, clinical research and regulatory affairs and the chief
medical officer and executive vice president at Hutchison MediPharma (Shanghai) Co., Ltd.
(ᔼᖹ(ɪऎ)ʮ̡), a subsidiary of Hutchison China MediTech Limited, a
company listed on the NASDAQ (ticker symbol: HCM), from May 2010 to January 2014; (iv)
the senior vice president of product and business development at the group of WuXi AppTec
Co., Ltd. (ʮ̡), a company listed on both the Stock Exchange
(stock code: 2359) and Shanghai Stock Exchange (stock code: 603259), from February 2014
to July 2016; (v) the chief medical officer at the group of Simcere Pharmaceutical Group
Limited (ʮ̡), a company listed on the Stock Exchange (stock code: 2096),
from August 2016 to January 2020; (vi) the venture partner at Hillhouse Bioventure from
February 2020 to April 2021; (vii) the interim chief executive officer and chief medical officer
at Overland Pharmaceuticals ( ᵌ༩ᖹุ) from December 2020 till his departure to next voyage;
and (viii) the chief executive officer, interim chief medical officer and China head at Zenas
BioPharma Inc., a company listed on the NASDAQ (ticker symbol: ZBIO), from April 2021 to
December 2023.
Dr. MU obtained a bachelor’s degree of medicine from Sichuan Medical College ( ̬ʇᔼ
ኪ৫) (currently known as West China Hospital, Sichuan University ( ̬ʇɽኪശГᔼ৫)) in
the PRC in April 1985, and a master’s degree in medicine from West China University of
Medical Sciences (ɽኪ) (currently known as The West China Medical Center,
Sichuan University ( ̬ʇɽኪശГᔼኪʕː)) in the PRC in July 1987. He further obtained a
Ph.D. in epidemiology from the University of California at Berkeley in the U.S. in December
1995.
DIRECTORS AND SENIOR MANAGEMENT
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Ms. GU Wei ( ᚥᑢ), aged 53, is our chief medical officer. She is mainly responsible for
leading clinical development team and developing clinical development strategies of our
Group.
Ms. GU possesses more than 10 years of experience in clinical trial management and
research. Her career began as a resident physician and then an attending physician at Huadong
Hospital Affiliated to Fudan University (ᔼ৫) from July 1996 to August
2002. From September 2002 to April 2004, Ms. GU worked for Quintiles Medical Development
(Shanghai) Co., Ltd. (࢝(ɪऎ)ʮ̡) with positions including clinical research
associate. From April 2004 to August 2010, Ms. GU worked at Boehringer Ingelheim
International Trading (Shanghai) Co., Ltd. (׸(ɪऎ)ʮ̡). During
August 2010 to July 2012, Ms. GU served as a director of clinical development at AstraZeneca
Global R&D (China) Co., Ltd. (೯(ʕ਷)ʮ̡), a subsidiary of
AstraZeneca plc, a biotechnology company listed on London Stock Exchange, Nasdaq
Stockholm and the Nasdaq Global Select Market under the stock symbol “AZN”, mainly
responsible for operations of clinical programs in Mainland China and Hong Kong. From July
2012 to September 2015, Ms. GU served as a senior director at Sino-American Shanghai
Squibb Pharmaceuticals Ltd. (ʮ̡), an affiliate of Shanghai
Pharmaceuticals Holding Co., Ltd. (ʮ̡), whose shares are listed on
both the Stock Exchange (stock code: 2607) and Shanghai Stock Exchange (stock code:
601607). From December 2015 to September 2016, Ms. GU worked for Shanghai Greenvalley
Pharmaceutical Co., Ltd. (ʮ̡). From October 2016 to January 2018, Ms.
GU served as a vice president at Shanghai Haihe Biopharma Co., Ltd. (Ӻක
ʮ̡), a biotechnology company focusing on innovative anti-tumor therapies. Later
from January 2018 to July 2022, Ms. GU worked for Shanghai Baili Jiasheng Pharmaceutical
Technology Co. (ʮ̡) (currently known as Novotel
Pharmaceutical Technology (Shanghai) Co., Ltd. (Ҧ(ɪऎ)ʮ̡)) with
positions including head of clinical development and regulatory and China chief medical
officer.
Ms. GU obtained a bachelor’s degree in clinical medicine and a master’s degree in
internal medicine from Shanghai Medical University (ɽኪ) (currently known as
Shanghai Medical College, Fudan University ( ూ͇ɽኪɪऎᔼኪ৫)) in the PRC in July 1994
and July 1996, respectively.
Mr. W ANG Xin (׿)Chartered Financial Analyst, aged 53, first joined our Group as
our senior vice president of strategy and business development and was further promoted as
chief business officer in March 2025. He is mainly responsible for the business development,
external cooperation and licensing strategies of our Group.
Mr. W ANG brings nearly 20 years of experience in healthcare research and banking,
accumulating from his tenure successively as an assistant scientist II, scientist I and then
associate scientist at Schering-Plough Research Institute from October 1997 to December
2001. Mr. W ANG joined the equity research team of Thomas Weisel Partners LLC as an
associate in January 2003 and then joined UBS Securities LLC in May 2004 as an associate
DIRECTORS AND SENIOR MANAGEMENT
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research analyst in equities. In March 2007, Mr. W ANG joined Mizuho Bank, Ltd. as a vice
president, primarily responsible for researching and analyzing industries including healthcare,
pharmaceuticals and biotechnology, and held positions including director, senior vice president
with his last position as executive director when his journey with Mizuho Bank, Ltd. came to
a close in September 2021.
Mr. W ANG obtained a bachelor’s degree in microbiology from Nankai University in the
PRC in July 1994, a master’s degree in biochemistry from University of British Columbia in
Canada in November 1996, and an MBA in finance and marketing from New Y ork University
in the United States in January 2003. In September 2023, he received the Community Service
Excellence Award at the 2023 Sino-American Pharmaceutical Professionals Association
Annual Conference.
Dr. HUA Haiqing (ऎ૶), aged 44, first joined our Group as our vice president and
head of drug discovery in July 2021 and was further promoted as senior vice president and head
of drug discovery in March 2024. He is mainly responsible for the pipeline development
strategies, new drug discovery and R&D of our Group.
Dr. HUA ’s career in the field of drug discovery and development spans for nearly 15
years. Dr. HUA had his postdoctoral training focusing on stem cell and gene therapy at
Columbia University Medical Center from 2009 to January 2014. From January 2014 to
February 2018, he served as a principal scientist at the Lilly China Research and Development
Co., Ltd. ( ᓿԸ(ʕ਷)ʮ̡), an affiliate of Eli Lilly, a company listed on the New Y ork
Stock Exchange (ticker symbol: LL Y). From February 2018 to June 2021, Dr. HUA worked for
Shanghai Hansoh BioMedical Co., Ltd. (ʮ̡), an indirect wholly-
owned subsidiary of Hansoh Pharmaceutical Group Company Limited (ʮ
̡), whose shares are listed on the Stock Exchange (stock code: 3692).
Dr. HUA obtained a bachelor’s degree in biological science from Tsinghua University ( ૶
ശɽኪ) in the PRC in July 2003, recognized as a doctor of natural sciences by University of
Zurich in Switzerland in July 2009. Dr. HUA was elected as a talent in Jiangsu Province
High-Level Creative Talent Strategic Plan (ྌ) in July 2019.
Mr. YU Xin ( ɲ㒥), aged 42, first joined our Group as head of regulatory affairs in August
2021 and was also appointed as our vice president in September 2022. He is mainly responsible
for overseeing regulatory affairs and product registration operations of our Group.
Mr. YU is a seasoned biotechnology professional with nearly 20 years’ experience in
pharmaceutical industry. In August 2004, he began his career at the Center for Drug Evaluation
of the NMPA (ᄲ൙ʕː), where he obtained a pharmacist
qualification in September 2006. Mr. YU’s career further expanded through his senior roles in
several pharmaceutical companies, with the focus staying at drug regulatory affairs and novel
drug development, including (i) an officer at Shanghai Roche Pharmaceutical Co., Ltd. ( ɪऎ
ʮ̡) from October 2006 to December 2007, responsible for imported drugs
registration in the PRC, (ii) the director of R&D center as his last position at Beijing Fresenius
DIRECTORS AND SENIOR MANAGEMENT
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Kabi Pharmaceutical Co., Ltd. (ʮ̡), a company mainly engaged
in R&D and production in the fields of infusion, blood transfusion, clinical nutrition,
pharmaceuticals and medical device, from July 2009 to November 2016, managing the drug
registration affairs and the center’s development, and (iii) a vice president at Alpha Biopharma
(Jiangsu) Co., Ltd. (ʮ̡), a drug innovation specializer, from
December 2017 to July 2021, responsible for the R&D management and registration of
innovative drugs R&D.
Mr. YU obtained a bachelor’s degree in pharmaceutical engineering, and a master’s
degree in pharmacy (pharmaceutical administration) from Shenyang Pharmaceutical University
(ɽኪ) in the PRC.
Dr. SHI Rong (࿰), aged 43, is our vice president of development science. She is
mainly responsible for leading team of clinical pharmacologists and bioanalysis of our Group.
Dr. SHI brings approximately 13 years of experience in global clinical research. From
February 2012 to January 2018, Dr. SHI served as a clinical pharmacologist of oncology at
E.R. Squibb & Sons LLC, a subsidiary of Bristol-Myers Squibb Company, Dr. SHI joined
Genentech Inc., a biotechnology company and subsidiary of Roche Holding AG, and Daiichi
Sankyo Inc. in January 2018 and February 2020, respectively.
Dr. SHI obtained a bachelor’s degree in pharmaceutical engineering from Zhejiang
University of Technology ( एϪʈุɽኪ) in the PRC in June 2004, a master’s degree of
science in chemistry from Missouri University of Science and Technology in the United States
in December 2006, and a Ph.D. from University of Florida in the United States in May 2011.
Dr. SHI was a participant in the research participation program at the Center for Drug
Evaluation and Research of FDA from May 2011 to January 2012.
Dr. CHU Ruiyin ( Ꮇ๿ვ), aged 63, is our vice president of translational medicine. He
is mainly responsible for management of the translational medicine department of our Group.
Dr. CHU brings over 20 years of experience in the global pharmaceutical industry. In July
2000, Dr. CHU joined Sanofi, a global pharmaceutical products manufacturer. During more
than ten years of service for Sanofi, he held positions including principal research investigator
and associate director, and led and advanced various early-stage discovery projects. He later
joined Hengrui USA, Ltd. in August 2021, a subsidiary of Jiangsu Hengrui Pharmaceuticals
Co., Ltd., leading its biomarker programs as a director of biomarker program leader
(oncology). Subsequently before joining us, in August 2022, Dr. CHU joined Cogent
Biosciences, Inc., a solution provider of genetically driven diseases listed on the Nasdaq (ticker
symbol: COGT) as a senior director of translational medicine.
Dr. CHU obtained a master’s degree and a Ph.D. from Chinese Academy of Agricultural
Sciences (ኪ৫) in the PRC in November 1986 and October 1990, respectively. Dr.
CHU completed a postdoctoral fellowship at Peking University in March 1992 and later
furthered his studies at Northwestern University in the United States.
DIRECTORS AND SENIOR MANAGEMENT
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Ms. ZHOU Lan ( մళ), aged 54, is our vice president of commercial strategy. She is
mainly responsible for the product commercialization strategy and government relationship of
our Group.
Ms. ZHOU brings nearly 17 years of experience in the healthcare and biotechnology
sectors. From August 2007 to December 2011, she worked for Shanghai branch of Eisai China
Inc. ( ሊҿ(ʕ਷)ʮ̡), which is indirectly wholly owned by Eisai Co., Ltd., a
Japanese pharmaceutical company listed on the Tokyo Stock Exchange (stock code: 4523).
From January 2012 to May 2018, she worked for Shanghai Roche Pharmaceuticals Limited ( ɪ
ʮ̡). From May 2018 to October 2020, she worked for Innovent Biologics
Technology Co., Ltd. (ʮ̡), an indirect wholly-owned subsidiary of
Innovent Biologics, Inc. (Ⴁᖹ), a biopharmaceutical company listed on the Stock
Exchange (stock code: 1801). Subsequently from November 2020 to November 2023, Ms.
ZHOU worked within the group of I-Mab, a company listed on the Nasdaq (ticker symbol:
IMAB) with her last position as vice president of operations.
Ms. ZHOU obtained an MBA from University of Leicester in the United Kingdom in July
2001 and an EMBA from Washington University in St. Louis in the United States in July 2020.
OTHER INFORMATION IN RELATION TO OUR DIRECTORS AND SENIOR
MANAGEMENT
Dr. ZHU Zhongyuan held positions in the following entities, each of which had dissolved
by deregistration under the relevant laws and regulations:
Name of
company
Place of
incorporation
Principal business
immediately prior to
cessation of business Roles
Reasons of
dissolution
Jiayu Investment
Management
(Hubei) Co.
Ltd. ( ྗ๎ҳ
༟၍ଣ(ಳ̏)
ʮ̡) /H1118/H1118/H1118
PRC Investment
management
Executive director
and general
manager
V oluntary
dissolution
Suzhou Y ucheng
Investment
Management
Co. Ltd. ( ᘽ
ҳ༟၍
ʮ̡) /H1118
PRC Investment
management
Executive director
and general
manager
V oluntary
dissolution
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Dr. ZHU Zhongyuan confirmed that to the best of his knowledge, (i) there was no
wrongful act on his part leading to the deregistration; (ii) each of the above companies was
solvent immediately prior to its deregistration and had no outstanding claim or liabilities
arising from any material non-compliance incidents; (iii) he has not received any notification
in respect of penalty, action or proceeding from relevant PRC or Hong Kong authorities as a
result of the deregistration; and (iv) he is not aware of any actual or potential claim which has
been or will be made against him as a result of the deregistration.
Save as disclosed above, to the best knowledge, information and belief of the Directors
having made all reasonable inquiries, there are no other material matters relating to their
appointment as a Director that need to be brought to the attention of our Shareholders and there
is no other information in relation to his or her appointment which is required to be disclosed
pursuant to Rule 13.51(2) of the Listing Rules as of the Latest Practicable Date.
Save as disclosed above, none of the Directors and senior management held any other
directorships in any other company listed in Hong Kong or overseas during the three years
immediately preceding the date of this prospectus.
None of our Directors and senior management is related to other Directors and senior
management.
JOINT COMPANY SECRETARIES
Ms. YUAN Jiali ( ঺Գᘆ), aged 38, is our head of legal and compliance and has been
appointed as one of the joint company secretaries of our Company with effect from the Listing
Date.
Ms. YUAN has been dedicating in legal services for over 15 years. Prior to joining our
Group, from September 2022 to July 2023, she served as the head of legal in Taizhou EOC
Jing’ang Pharmaceutical Co., Ltd. (ʮ̡). From November 2017 to
August 2022, she was employed within the group of Fosun International Limited (਷ყϞ
ʮ̡), whose shares are listed on the Stock Exchange (stock code: 656), and Shanghai Fosun
Pharmaceutical (Group) Co., Ltd. (ᔼᖹ(ණྠ)ʮ̡), a company listed on
both the Stock Exchange (stock code: 2196) and Shanghai Stock Exchange (stock code:
600196), successively serving as legal director, senior legal director, legal executive director
and general manager assistant. From April 2011 to May 2017, Ms. YUAN served as an attorney
in Beijing Dentons (Shanghai) Law Office (הfocusing on domestic
and outbound investment, financing, merger and acquisitions, and commercial dispute
resolution. From August 2009 to February 2011, she worked in Rolmax Law Offices.
Ms. YUAN obtained a bachelor’s degree in international economics law from Shanghai
Institute of Foreign Trade (ኪ৫) (currently known as Shanghai University of
International Business and Economics ( ɪऎ࿁̮຾൱ɽኪ)) in June 2009, and a master’s
degree in public policy from the University of Tokyo in Japan in June 2017.
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Ms. TSANG Wing Man ( ಀ጑ත) (“Ms. Tsang ”) was appointed as one of the joint
company secretaries of our Company with effect from August 12, 2024. Ms. Tsang holds a
bachelor’s degree in business administration from City University of Hong Kong. She currently
serves as a manager of SWCS Corporate Services Group (Hong Kong) Limited and has over
10 years of experience in company secretarial matters. She is an associate member of The
Chartered Governance Institute and The Hong Kong Chartered Governance Institute.
BOARD COMMITTEES
Our Company has established three committees under the Board pursuant to the corporate
governance practice requirements under the Listing Rules, including the Audit Committee,
Remuneration Committee and Nomination Committee.
Audit Committee
We have established an Audit Committee in compliance with Rule 3.21 of the Listing
Rules and the Corporate Governance Code set out in Appendix C1 to the Listing Rules. The
primary duties of the Audit Committee are to (i) review and supervise our financial reporting
process and internal control system, risk management and internal audit of our Group; (ii)
provide advice and comments to our Board in respect of financial risk, risk management and
internal control matters; and (iii) perform other duties and responsibilities as may be assigned
by the Board.
The Audit Committee comprises three independent non-executive Directors, namely, Mr.
XIE Dong (؇Mr. GAO Fengyong (ۇand Ms. CHUAI Shuyin ( ౣ᪣ত), Mr. XIE
Dong (؇is the chairperson of the Audit Committee. He holds the appropriate professional
qualifications as required under Rules 3.10(2) and 3.21 of the Listing Rules.
Remuneration Committee
We have established a Remuneration Committee in compliance with Rule 3.25 of the
Listing Rules and the Corporate Governance Code set out in Appendix C1 to the Listing Rules.
The primary duties of the Remuneration Committee include, but are not limited to, the
following: (i) making recommendations to our Board on our policy and structure for all
remuneration of Directors and senior management and on the establishment of a formal and
transparent procedure for developing policy on such remuneration; and (ii) reviewing and
approving matters relating to share schemes of our Company.
The Remuneration Committee comprises one executive Director and two independent
non-executive Directors, namely, Ms. CHUAI Shuyin ( ౣ᪣ত), Mr. GAO Fengyong (ۇ)
and Ms. SI Wen ( ̡˖). Ms. CHUAI Shuyin ( ౣ᪣ত) is the chairperson of the Remuneration
Committee.
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Nomination Committee
We have established a Nomination Committee in compliance with Rule 3.27A of the
Listing Rules and the Corporate Governance Code set out in Appendix C1 to the Listing Rules.
The primary duties of the Nomination Committee include, but are not limited to, (i) reviewing
the structure, size and composition of our Board on a regular basis and make recommendations
to the Board regarding any proposed changes to the composition of our Board; (ii) identifying,
selecting or making recommendations to our Board on the selection of individuals nominated
for directorship, and ensuring the diversity of our Board members; (iii) performing review on
the contributions made by our Directors (including our independent non-executive Directors)
and the sufficiency of time devoted to perform their duties; (iv) assessing the independence of
our independent non-executive Directors; and (v) making recommendations to our Board on
relevant matters relating to the appointment, re-appointment and removal of our Directors.
The Nomination Committee comprises one executive Director and two independent
non-executive Directors, namely, Dr. ZHU Zhongyuan (Ⴣ), Ms. CHUAI Shuyin ( ౣ᪣ত)
and Mr. XIE Dong (؇Dr. ZHU Zhongyuan (Ⴣ) is the chairperson of the Nomination
Committee.
DIRECTORS’ AND SENIOR MANAGEMENT’S REMUNERATION
Our Directors and senior management receive remuneration, including salaries,
discretionary bonus, share-based compensation expenses, pension costs and other benefits. The
aggregate amount of remuneration for the five highest paid individuals of our Group, who is
neither a Director nor chief executive of the Company, for the two years ended December 31,
2023 and 2024 was approximately RMB22.4 million and RMB58.1 million, respectively.
The aggregate amount of remuneration for our Directors for the two years ended
December 31, 2023 and 2024 was approximately RMB22.0 million and RMB94.3 million,
respectively.
The significant increase in the aggregate amount of remuneration paid or payable to our
Directors and five highest paid individuals during the year ended December 31, 2024 was
primarily due to the increase in the share-based payments resulting from the grant of share
options and the increase of IPO probability in the corresponding period. For further details, see
Notes 7 and 32 to the Accountant’s Report set out in Appendix I to this prospectus.
According to existing effective arrangements, the total amount of remuneration
(excluding any possible payment of discretionary bonus and share-based compensation
expenses) shall be paid by us to Directors for the financial year ending December 31, 2025 is
expected to be approximately RMB15.5 million.
Save as disclosed above, no other payments have been paid or are payable by our
Company to our Directors or senior management for the Track Record Period.
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Save as disclosed in this prospectus, no bonuses were paid or receivable by our Directors
which were discretionary or were based on our Company’s, our Group’s or any member of our
Group’s performance for the Track Record Period.
No remuneration was paid to our Directors or the five highest paid individuals as an
inducement to join, or upon joining, our Group. No compensation was paid to, or receivable
by, our Directors or past directors for the Track Record Period for the loss of office as director
or any member of our Group or of any other office in connection with the management of the
affairs of any member of our Group. None of our Directors waived any emoluments during the
Track Record Period.
COMPLIANCE ADVISOR
We have appointed First Shanghai Capital Limited as our Compliance Advisor pursuant
to Rule 3A.19 of the Listing Rules. Our Compliance Advisor will provide us with guidance and
advice as to compliance with the Listing Rules and applicable Hong Kong laws. Pursuant to
Rule 3A.23 of the Listing Rules, our Compliance Advisor will advise our Company in certain
circumstances including:
(i) before the publication of any regulatory announcement, circular, or financial report;
(ii) where a transaction, which might be a notifiable or connected transaction, is
contemplated, including share issues, sales or transfers of treasury shares and share
repurchases; and
(iii) where we propose to use the proceeds of the Global Offering in a manner different
from that detailed in this prospectus or where the business activities, development
or results of our Group deviate from any forecast, estimate or other information in
this prospectus; and where the 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 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 applicable requirements under the Listing Rules and laws and regulations.
The term of appointment of our Compliance Advisor shall commence on the Listing Date
and is expected to end 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.
DIRECTORS AND SENIOR MANAGEMENT
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--- page 513 ---
CORPORATE GOVERNANCE CODE
Our Directors recognize the importance of incorporating elements of good corporate
governance in the management structures and internal control procedures of our Group to
achieve effective accountability. Our Company intends to comply with all code provisions in
the Part 2 of the Corporate Governance Code as set out in Appendix C1 to the Listing Rules
after the Listing except for code provision C.2.1 of Part 2 of the Corporate Governance Code,
which provides that the roles of chairman of the board and chief executive should be separate
and should not be performed by the same individual.
The roles of chairman and chief executive officer of our Company are currently
performed by Dr. ZHU. In view of Dr. ZHU’s substantial contribution to our Group since our
establishment and his extensive experience, we consider that having Dr. ZHU acting as both
our chairman and chief executive officer will provide strong and consistent leadership to our
Group and facilitate the efficient execution of our business strategies. We consider it
appropriate and beneficial to our business development and prospects that Dr. ZHU continues
to act as both our chairman and chief executive officer after the Listing, and therefore currently
do not propose to separate the functions of chairman and chief executive officer. While this
would constitute a deviation from code provision C.2.1 of Part 2 of the Corporate Governance
Code, the Board believes that this structure will not impair the balance of power and authority
between the Board and the management of our Company, given that: (i) there are sufficient
checks and balances in the Board, as a decision to be made by our Board requires approval by
at least a majority of our Directors, and our Board comprises three independent non-executive
Directors, which is in compliance with the requirement under the Listing Rules; (ii) Dr. ZHU
and the other Directors are aware of and undertake to fulfill their fiduciary duties as Directors,
which require, among other things, that he acts for the benefit and in the best interests of our
Company and will make decisions for our Group accordingly; and (iii) the balance of power
and authority is ensured by the operations of the Board which comprises experienced and high
caliber individuals who meet regularly to discuss issues affecting the operations of our
Company. Moreover, the overall strategic and other key business, financial, and operational
policies of our Group are made collectively after thorough discussion at both Board and senior
management levels. The Board will continue to review the effectiveness of the corporate
governance structure of our Group in order to assess whether the separation of the roles of
chairman and chief executive officer is necessary.
MANAGEMENT PRESENCE
According to Rule 8.12 of the Listing Rules, we must have sufficient management
presence in Hong Kong. This normally means that at least two of our executive Directors must
be ordinarily resident in Hong Kong. Since the principal business operations of our Group are
conducted in Mainland China, members of our senior management are, and are expected to
continue to be, based in Mainland China. Further, as our executive Directors have a vital role
in our Group’s operations, it is crucial for them to remain in close proximity to our Group’s
central management located in Mainland China. Our Company does not and, for the foreseeable
future, will not have a sufficient management presence in Hong Kong. We have applied for, and
DIRECTORS AND SENIOR MANAGEMENT
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--- page 514 ---
the Stock Exchange has granted, a waiver from compliance with Rule 8.12 of the Listing Rules.
For further details, see “Waivers from Strict Compliance with the Listing Rules and
Exemptions from the Companies (Winding Up and Miscellaneous Provisions) Ordinance —
Management Presence in Hong Kong.”
BOARD DIVERSITY POLICY
Our Board has adopted a board diversity policy which sets out the approach to achieve
diversity on our Board. Our Company recognizes and embraces the benefits of having a diverse
Board and sees increasing diversity at the Board level as an essential element in supporting the
attainment of our Company’s strategic objectives and sustainable development. Our Company
seeks to achieve Board diversity through the consideration of a number of factors, including
but not limited to talent, skills, gender, age, cultural and educational background, ethnicity,
professional experience, independence, knowledge and length of service. We will select
potential Board candidates based on merit and their potential contribution to our Board while
taking into consideration our own business model and specific needs from time to time. All
Board appointments will be based on meritocracy and candidates will be considered against
objective criteria, having due regard to the benefits of diversity on our Board.
Our Board has a balanced mix of knowledge, skills and experience. They completed
studies in various majors including but without limitation to molecular biology, biochemistry
and polymer biology, business administration, international accounting, economics, managerial
psychology, science, biomedical engineering, Korean language and culture, Asian and African
languages and literatures, art and human resources and industrial relations. We have three
independent non-executive Directors who have different industry backgrounds. Furthermore,
our Directors are of a wide range of age, from 39 to 54 years old. Taking into account our
business model and specific needs as well as the presence of two female Directors out of a total
of eight Board members, we consider that the composition of our Board satisfies our board
diversity policy.
We recognize the particular importance of gender diversity on our Board. We have taken
and will continue to take steps to promote and enhance gender diversity at all levels of our
Company, including but without limitation at our Board and senior management levels. Our
board diversity policy provides that our Board shall take opportunities when selecting and
making recommendations on suitable candidates for Board appointments with the aim of
increasing the proportion of female members over time after Listing. In particular, taking into
account the business needs of our Group and changing circumstances that may affect our
business plans, we will actively identify and select several female individuals with a diverse
range of skills, experience and knowledge in different fields from time to time, and maintain
a list of such female individuals who possess qualities to become our Board members, which
will be periodically reviewed by our Nomination Committee in order to develop a pipeline of
potential successors to our Board and promote gender diversity. Additionally, female
representatives of our investors are also considered as potential candidates for Board
appointments. We will also ensure that there is gender diversity when recruiting staff at the
mid- to senior- levels so that we have a pipeline of female senior management and potential
DIRECTORS AND SENIOR MANAGEMENT
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--- page 515 ---
successors to our Board going forward. We plan to offer well-rounded trainings to female
employees whom we consider have the requisite experience, skills and knowledge of our
operation and business, on topics including but not limited to business operation, management,
accounting and finance, and legal compliance. We are of the view that such strategies will
provide our Board with ample opportunities to identify capable female employees to be
nominated as Directors in the future, fulfilling our aim to develop a pipeline of female
candidates to achieve greater gender diversity in our Board in the long run. We believe that
such a merit-based selection process with reference to our diversity policy and the nature of our
business will be in the best interests of our Company and our Shareholders as a whole. It is our
objective to maintain an appropriate balance of gender diversity with reference to the
stakeholders’ expectations and international and local recommended best practices.
Our Nomination Committee is responsible for ensuring the diversity of our Board
members. After Listing, our Nomination Committee will review our board diversity policy and
its implementation annually to monitor its continued effectiveness and we will disclose the
implementation of our board diversity policy, including any measurable objectives set for
implementing the board diversity policy and the progress on achieving these objectives, in our
corporate governance report on an annual basis.
KEY TERMS OF EMPLOYMENT CONTRACTS
We normally enter into employment contracts, confidentiality agreements and non-
competition agreements with our senior management members and other key personnel. Below
sets forth the key terms of these contracts we enter into with our senior management and other
key personnel.
Non-competition
Within two years from the date of the employee’s departure and during the course of
employment by our Group, he/she shall not, among others, directly or indirectly engage in any
business activities which are similar or competitive with the business of our Group. In addition,
the employee shall not work for nor provide any financial assistance, guarantees or advice to
any other entities that may compete with our Group.
Confidentiality
The employee shall keep in confidence and shall not disclose our trade secrets, including
but not limited to our business strategy and approaches, marketing or pricing activities,
business development plans, customer information, financial information, various research
data, other information that is deemed as confidential by our Group or our business partners
and should be kept in confidence by our Group, and other information, that is disclosed to or
obtained by the employee directly or indirectly from our Company or other members of our
Group during the term of their employment.
DIRECTORS AND SENIOR MANAGEMENT
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--- page 516 ---
Service Invention
The intellectual property rights in any invention, work, design, copyrights or any other
intellectual property that is (i) resulted from performing employee duties, (ii) produced from
other tasks assigned by our Company, (iii) developed within one year from the date of the
employee’s departure and related to his/her previous duties or tasks in our Group, or (iv)
developed mainly using our material, technologies and information, shall belong to us.
CONFIRMATIONS FROM OUR DIRECTORS
Rule 8.10 of the Listing Rules
Each of our Directors confirms that as of the Latest Practicable Date, they did not have
any interest in a business which competes or is likely to compete, directly or indirectly, with
our business and requires disclosure under Rule 8.10 of the Listing Rules.
From time to time our non-executive Directors may serve on the boards of both private
and public companies within the broader healthcare and biopharmaceutical industries.
However, as these non-executive Directors are not members of our executive management
team, we do not believe that their interests in such companies as directors would render us
incapable of carrying on our business independently from the other companies in which these
non-executive Directors may hold directorships from time to time.
Rule 3.09D of the Listing Rules
Each of our Directors confirms that they (i) have obtained the legal advice referred to
under Rule 3.09D of the Listing Rules on July 29, 2024, July 31, 2024 or August 1, 2024, and
(ii) understand their 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) their independence as
regards each of the factors referred to in Rules 3.13(1) to (8) of the Listing Rules, (ii) they have
no past or present financial or other interest in the business of our Company or its subsidiaries
or any connection with any core connected person of our Company under the Listing Rules as
of the Latest Practicable Date, and (iii) that there are no other factors that may affect their
independence at the time of their appointments.
DIRECTORS AND SENIOR MANAGEMENT
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--- page 517 ---
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 forth 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
100 Shares) that may be purchased for an aggregate amount of US$65.0 million (or
approximately HK$505.4 million, calculated based on an exchange rate of US$1.00 to
HK$7.7761) (exclusive of the brokerage, SFC transaction levy, AFRC transaction levy and
Stock Exchange trading fee) (the “ Cornerstone Placing ”).
Assuming an Offer Price of HK$94.60 (being the low-end of the indicative Offer Price
range set out in this prospectus), the total number of Offer Shares to be subscribed by the
Cornerstone Investors would be approximately 5,341,900 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 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
% of the Shares
in issue upon
completion of the
Global Offering
Approximate
%o ft h e
Offer Shares
Approximate
% of the Shares
in issue upon
completion of the
Global Offering
Approximate
%o ft h e
Offer Shares
Approximate
% of the Shares
in issue upon
completion of the
Global Offering
Approximate
%o ft h e
Offer Shares
Approximate
%o ft h eS h a r e s
in issue upon
completion of the
Global Offering
35.44% 6.42% 30.82% 6.25% 30.82% 6.25% 26.80% 6.07%
Assuming an Offer Price of HK$98.90 (being the mid-point of the indicative Offer Price
range set out in this prospectus), the total number of Offer Shares to be subscribed by the
Cornerstone Investors would be approximately 5,110,300 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 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
% of the Shares
in issue upon
completion of the
Global Offering
Approximate
%o ft h e
Offer Shares
Approximate
% of the Shares
in issue upon
completion of the
Global Offering
Approximate
%o ft h e
Offer Shares
Approximate
% of the Shares
in issue upon
completion of the
Global Offering
Approximate
%o ft h e
Offer Shares
Approximate
%o ft h eS h a r e s
in issue upon
completion of the
Global Offering
33.91% 6.14% 29.48% 5.98% 29.48% 5.98% 25.64% 5.80%
CORNERSTONE INVESTORS
– 507 –


--- page 518 ---
Assuming an Offer Price of HK$103.20 (being the high-end of the indicative Offer Price
range set out in this prospectus), the total number of Offer Shares to be subscribed by the
Cornerstone Investors would be approximately 4,896,900 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 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
% of the Shares
in issue upon
completion of the
Global Offering
Approximate
%o ft h e
Offer Shares
Approximate
% of the Shares
in issue upon
completion of the
Global Offering
Approximate
%o ft h e
Offer Shares
Approximate
% of the Shares
in issue upon
completion of the
Global Offering
Approximate
%o ft h e
Offer Shares
Approximate
%o ft h eS h a r e s
in issue upon
completion of the
Global Offering
32.49% 5.89% 28.25% 5.73% 28.25% 5.73% 24.57% 5.56%
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.
Among the Cornerstone Investors,(i) LA V Star (as defined below) is a close associate of
LA V Fund VI, L.P . and LA V Fund VI Opportunities, L.P . (together “ LA V USD”), each an
existing shareholders of our Company and (ii) Suzhou Suchuang (as defined below) is an entity
controlled by the Finance Bureau of Suzhou Municipality (҅), which is ultimately
administered and supervised by Suzhou Municipal People’s Government, for the purpose of
Suzhou Suchuang’s participation in the Cornerstone Placing, is considered as a close associate
of China Singapore Suzhou Industrial Park V entures (ʮ̡)
(“CSVC ”), an existing shareholder of our Company, which is controlled by a subordinate
government agency (̈ዚ࿴) under Suzhou Municipal People’s Government. LA V Star
has been permitted to participate in the Cornerstone Placing pursuant to paragraph 18 of
Chapter 2.3 of the Guide under a waiver from strict compliance with the requirements under
Rule 9.09(b) of the Listing Rules, and a waiver consent under paragraph 5(2) of Appendix F1
to the Listing Rules granted by the Stock Exchange. Suzhou Suchuang has been permitted to
participate in the Cornerstone Placing pursuant to paragraph 18 of Chapter 2.3 of the Guide,
and a waiver consent under paragraph 5(2) of Appendix F1 to the Listing Rules granted by the
Stock Exchange. For further details of the abovementioned waivers and consents, see “Waivers
from Strict Compliance with the Listing Rules and Exemptions from the Companies (Winding
Up and Miscellaneous Provisions) Ordinance” in this prospectus. For details of LA V USD and
CSVC, see “History and Corporate Structure — Pre-IPO Investments — Information regarding
the Pre-IPO Investors.” As the Offer Shares to be subscribed by LA V Star shall be aggregated
with the existing Shares held by LA V USD, the Offer Shares to be subscribed by LA V Star will
not count towards the public float of the Company under Rule 8.08 of the Listing Rules.
CORNERSTONE INVESTORS
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--- page 519 ---
The Cornerstone Placing will form part of the International Offering and, save as
otherwise obtained consent from the Stock Exchange, the Cornerstone Investors will not
acquire any Offer Shares under the Global Offering other than pursuant to the Cornerstone
Investment Agreements. 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 will be counted towards
the public float for the purpose of Rule 8.08 of the Listing Rules (other than the Offer Shares
to be subscribed by LA V Star)) and in compliance with the requirement under Rule 8.08(3) of
the Listing Rules. The Offer Shares to be subscribed by the Cornerstone Investors will not be
counted towards the public float of our Company for the purpose of Rule 18A.07 of the Listing
Rules. Immediately following the completion of the Global Offering: (i) none of the
Cornerstone Investors (other than LA V Star) or their close associates will become a substantial
shareholder of our Company; (ii) none of the Cornerstone Investors (other than LA V Star) or
their close associates will have any Board representation in our Company; and (iii) the three
largest public Shareholders will hold no more than 50% of the Shares held in public hands for
the purpose of Rule 8.08(3) of the Listing Rules. 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. Upon completion of the Global Offering, over 25% of our issued share capital
will be held by the public as required under Rule 8.08(1)(a) of the Listing Rules and shares
with a market capitalization of at least HK$375 million will be held by the public as required
under Rule 18A.07 of the Listing Rules.
As confirmed by each of the Cornerstone Investors, there are no side agreements or
arrangements between our Company and the Cornerstone Investors, or any benefit, direct or
indirect, conferred on the Cornerstone Investors by virtue of or in relation to the Global
Offering other than a guaranteed allocation of the relevant Offer Shares at the Offer Price.
Some of the Cornerstone Investors have agreed that, our Company, the Joint
Representatives and the Joint Sponsors 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
pay for the relevant Offer Shares no later than one business day before the Listing Date. As
such, there will not be any deferred settlement in payment by the Cornerstone Investors. The
maximum number of Offer Shares that could be subject to the delayed delivery arrangement is
the maximum number of Shares to be allotted under the Over-allotment Option, i.e. 2,260,700
Shares assuming the Offer Size Adjustment Option is not exercised or 2,599,800 Shares
assuming the Offer Size Adjustment Option is exercised in full. For details of the
Over-allotment Option and the stabilization action by the Stabilizing Manager, please refer to
the paragraphs headed “Structure of the Global Offering — Over-Allotment Option” and
“Structure of the Global Offering — Stabilization” in this prospectus, respectively.
CORNERSTONE INVESTORS
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--- page 520 ---
To the best of the knowledge, information and belief of our Company, (i) each of the
Cornerstone Investors and its ultimate beneficial owners (other than LA V Star and its ultimate
beneficial owner) is an Independent Third Party; (ii) save as LA V Star which is a close
associate of and takes instructions from LA V USD, none of the remaining Cornerstone
Investors is accustomed to take and has not taken instructions from our Company, our
Directors, chief executive, substantial Shareholders, existing Shareholders or any of its
subsidiaries or their respective close associates in relation to the acquisition, disposal, voting
or other disposition of the Offer Shares registered in its name or otherwise held by it; (iii) save
as LA V Star which is a close associate of and directly or indirectly financed, funded or backed
by LA V USD, none of the subscription of the Offer Shares by the remaining Cornerstone
Investors is directly or indirectly financed, funded or backed by our Company, our Directors,
chief executive, substantial Shareholders, existing Shareholders or any of its subsidiaries or
their respective close associates; and (iv) each of the Cornerstone Investors is independent
from each other and makes independent investment decisions. In addition, BioNTech SE is a
collaboration partner with the Company. For details, see “Business — Our Collaboration and
Licensing Arrangements.”
To the best knowledge of our Company and as confirmed by each of the Cornerstone
Investors, (i) each of the Cornerstone Investors’ subscription under the Cornerstone Investment
Agreements would be financed by their own internal resources or the assets managed for its
investors (in the case of Cornerstone Investors which are funds or investment managers); (ii)
to the best of the Company’s knowledge, save as BioNTech SE, the respective shareholders of
each of Fullgoal Fund, Fullgoal HK, E Fund Management, E Fund HK and CUAM (each
defined as below), none of the Cornerstone Investors or their shareholder(s) are listed on any
stock exchanges; and (iii) all necessary approvals have been obtained with respect to the
Cornerstone Placing, and that no specific approval from any stock exchange (if relevant) or its
shareholders is required for the relevant cornerstone investments.
The total 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 in the event of over-subscription
under the Hong Kong Public Offering as described in the section headed “Structure of the
Global Offering — The Hong Kong Public Offering — Reallocation and Clawback.” Each of
the Cornerstone Investors has agreed that if the total demand for Shares in the Hong Kong
Public Offering falls within the circumstances as set out in the aforesaid section of this
prospectus, the number of Offer Shares to be subscribed by each Cornerstone Investor shall be
reduced on a pro rata basis to satisfy the shortfall, after taking into account the requirements
under Appendix F1 to the Listing Rules as well as the discretion of the Joint Representatives
(for themselves and on behalf of the International Underwriters). Details of the actual number
of Offer Shares to be allocated to the Cornerstone Investors will be disclosed in the allotment
results announcement of our Company to be published on or around April 14, 2025.
All of the Cornerstone Investors have confirmed that they have sufficient funds to settle
the investment amounts and they will pay and settle in full for the relevant Offer Shares that
they have subscribed before dealings in the Offer Shares commence on the Stock Exchange.
CORNERSTONE INVESTORS
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--- page 521 ---
OUR CORNERSTONE INVESTORS
The following information about the Cornerstone Investors were provided to our
Company by the Cornerstone Investors in connection with the Cornerstone Placing.
BioNTech SE
BioNTech SE (“ BioNTech ”) is an international company headquartered in Germany,
whose American Depositary Receipts (ADRs) are listed on the Nasdaq Stock Market (symbol:
BNTX). BioNTech is a global next-generation immunotherapy company pioneering novel
investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array
of computational discovery and therapeutic modalities with the intent of rapid development of
novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to
address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation
immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and
innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in
mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators
are researching and developing multiple mRNA vaccine candidates for a range of infectious
diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of
relationships with multiple global and specialized pharmaceutical collaborators, including our
Company.
LA V Star Opportunities Limited
LA V Star Opportunities Limited (“ LA V Star ”) is wholly-owned by LA V Fund VI
Opportunities, L.P . (“ LA V Opportunities ”). LA V Opportunities is a Cayman Islands exempted
limited partnership and none of the limited partners in LA V Opportunities holds 30% or more
interest. The general partner of LA V Opportunities is LA V GP VI Opportunities, L.P . The
general partner of LA V GP VI Opportunities, L.P . is LA V Corporate VI GP Opportunities, Ltd.
LA V Corporate VI GP Opportunities, Ltd. is a Cayman Islands exempted company wholly
owned by Dr. SHI Yi. LA V Opportunities is within a group of offshore investment vehicles, the
investments of which are denominated in U.S. dollar, controlled by Dr. SHI Yi (“ LA V USD
Group ”). As of the Latest Practicable Date, LA V USD Group had assets under management of
approximately US$3.5 billion and invested in over one hundred portfolios covering all major
sectors of the biomedical and healthcare industry including biopharmaceuticals, medical
devices, diagnostics and healthcare services, examples including ArriV ent BioPharma, Inc., a
company listed on the NASDAQ (symbol: A VBP), Abbisko Cayman Limited, a company listed
on the Stock Exchange (stock code: 2256) and Jacobio Pharmaceuticals Group Co., Ltd., a
company listed on the Stock Exchange (stock code: 1167).
CORNERSTONE INVESTORS
–5 1 1–


--- page 522 ---
Lake Bleu Prime Healthcare Master Fund Limited and Lake Bleu Innovation Healthcare
Master Fund Limited
Lake Bleu Prime Healthcare Master Fund Limited (“ Lake Bleu Prime ”) is managed by
Lake Bleu Capital (Hong Kong) 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 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 (Hong Kong) Limited is also licensed by the SFC to
carry out type 9 regulated activities.
Lake Bleu Innovation Healthcare Master Fund Limited (“ Lake Bleu Innovation ”) is
managed by Lake Bleu Capital (Hong Kong) 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. Lake Bleu Capital (Hong Kong) Limited is also licensed by the SFC to
carry out type 9 regulated activities. None of those investors hold 30% or more of its interest
in Lake Bleu Prime and Lake Bleu Innovation, respectively. To the best of the knowledge,
information and belief of our Company, Lake Bleu Prime and Lake Bleu innovation, together
with their ultimate beneficial owners, are Independent Third Parties.
TruMed Healthcare Master Fund, ABS Direct Equity Fund LLC Asia Series 11 and
TruMed Health Innovation Fund LP (together “TruMed”)
TruMed Healthcare Master Fund, an exempted limited partnership incorporated in the
Cayman Islands, is a healthcare focused pooled investment fund whose general partner is
TruMed Investment Management Limited. Ms. Ting Wang is the ultimate beneficial owner of
TruMed Investment Management Limited. TruMed Healthcare Master Fund has over 10
investors. Save as Ms. Ting Wang who ultimately beneficially owns more than 30% interest in
TruMed Healthcare Master Fund and is an Independent Third Party, each of the remaining
limited partners holds less than 30% interest in TruMed Healthcare Master Fund.
ABS Direct Equity Fund LLC Asia Series 11 is a fund incorporated under the law of
Delaware of the United States and focused on the investment in healthcare field, whose
investment advisor is TruMed Investment Management Limited. None of the investors of ABS
Direct Equity Fund LLC Asia Series 11 holds 30% or more equity interest therein.
CORNERSTONE INVESTORS
– 512 –


--- page 523 ---
TruMed Health Innovation Fund LP is an exempted limited partnership incorporated in
the Cayman Islands and it is a pooled investment fund primarily investing in healthcare
equities. whose general partner is TruMed Health Innovation Fund GP Limited. Ms. Ting Wang
is the ultimate beneficial owner of 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 .
Fullgoal Asset Management (HK) Limited and Fullgoal Fund Management Co., Ltd. ( బ
ʮ̡)
Established in 2012 in Hong Kong, Fullgoal Asset Management (HK) Limited (“ Fullgoal
HK”) is a wholly owned subsidiary of Fullgoal Fund Management Co., Ltd. (“ 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. As confirmed by Fullgoal HK, no
single ultimate beneficial owner holds 30% or more interests in such funds except for one
individual underlying professional investor, namely ZHAO Xueming, who, to the best
knowledge of Fullgoal HK, is an Independent Third Party of the Company.
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 receive full license 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 average
monthly scale of non-monetary market mutual funds under the management of Fullgoal Fund
was approximately RMB610 billion as of September 30, 2024.
The shareholders of Fullgoal Fund include (i) Guotai Junan Securities Co., Ltd. ( ਷इё
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.
E Fund Management Co., Ltd. (ʮ̡) and E Fund Management (Hong
Kong) Co., Ltd. (ʮ̡)
E Fund Management Co., Ltd. (ʮ̡)( “ E Fund Management ”), is
a leading comprehensive asset management company in the PRC. As of December 31, 2024,
E Fund Management had over RMB3.5 trillion in assets under management. E Fund
Management is a QDII approved by the relevant PRC authority and targets at companies with
competitive edge over its competitors in the global healthcare sector. E Fund Management is
a fund manager managing assets on behalf of its underlying clients. The shareholders of E Fund
Management include (1) Guangdong Finance Trust Co., Ltd. (ʮ̡), (2) GF
CORNERSTONE INVESTORS
– 513 –


--- page 524 ---
Securities Co., Ltd. (ʮ̡)( “ GF Securities ”), which is listed on the Stock
Exchange (stock code: 1776) and the Shenzhen Stock Exchange (stock code: 000776), and (3)
Infore Holding Group Co., Ltd (ʮ̡), each holding 22.65% in E Fund
Group. The approval of the shareholders of GF Securities, the Hong Kong Stock Exchange or
the Shenzhen Stock Exchange is not required for the subscription for the Offer Shares pursuant
to the relevant Cornerstone Investment Agreement.
E Fund Management (Hong Kong) Co., Ltd. (ʮ̡)( “ E Fund
HK”) is a wholly-owned subsidiary of E Fund Management. E Fund HK was incorporated in
Hong Kong in August 2008. E Fund HK is licensed for Type 1 (Dealing in Securities), Type
4 (Advising on Securities) and Type 9 (Asset Management) regulated activities by the SFC. E
Fund HK serves as the global investment and business platform for its parent company, E Fund
Management. As E Fund Management’s window company overseas, E Fund HK strategically
connects China and the overseas market. E Fund HK capitalizes the investment and research
capabilities of E Fund Management and its competitive advantage in the overseas market to
provide comprehensive quality service to its clients. As of January 31, 2025, E Fund HK had
over HK$124.6 billion in assets under management.
The Offer Shares to be allocated and issued to E Fund Management and E Fund HK 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 the Company, E Fund Management and E Fund HK.
GF Securities holds 22.65% of the issued share capital of E Fund Management and GF
Securities (Hong Kong) Brokerage Limited (“ GF Securities Brokerage ”) is an indirect
wholly-owned subsidiary of GF Securities. E Fund Management is a member of the same group
of companies as GF Securities and therefore is a “connected client” of GF Securities.
Notwithstanding GF Securities’ shareholding in E Fund Management and that E Fund
Management and GF Securities are members of the same group of companies, (i) GF Securities
does not have control over E Fund Management by virtue of its shareholding or control over
the board of directors of E Fund Management; and (ii) E Fund Management operates and makes
investment decisions independently from GF Securities and/or GF Securities Brokerage. E
Fund Management and E Fund HK are to invest on discretionary basis on behalf of Independent
Third Parties and no proprietary money is used for the placing. We have applied to the Stock
Exchange for, the Stock Exchange has granted us, its consent under paragraph 5(1) of the
Appendix F1 to the Listing Rules to permit E Fund Management and E Fund HK to participate
in the Global Offering as cornerstone investors subject to certain conditions. For details, see
“Waivers from Strict Compliance with the Listing Rules and Exemptions from the Companies
(Winding Up and Miscellaneous Provisions) Ordinance” in this prospectus.
China Universal Asset Management Co., Ltd.
China Universal Asset Management Co., Ltd. (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
CORNERSTONE INVESTORS
– 514 –


--- page 525 ---
possesses all the licenses required to engage in fund management business in the securities
industry in the PRC. As of December 31, 2024, CUAM managed hundreds of public funds,
covering equity funds, bond funds, index funds, QDII funds, mixed funds and money market
funds. As of December 31, 2024, CUAM had approximately RMB893.3 billion in assets under
management. Its investment portfolio includes, among others, Sichuan Kelun-Biotech
Biopharmaceutical Co., Ltd. (ʮ̡), a biotech company listed
on the Stock Exchange (stock code: 6990), Fruit Express China Holdings Limited (෤ණ
ʮ̡), a fruit retail company listed on the Stock Exchange (stock code: 02411.HK).
Giant Biogene Holdings Company Limited (ʮ̡), a biotechnology
company listed on the Stock Exchange (stock code: 02367.HK). Ferretti Group Holdings
Company Limited (ʮ̡), a luxury yacht manufacturing company listed
on the Stock Exchange (stock code: 09633.HK).
CUAM is a QDII approved by the relevant PRC authority and is owned by Orient
Securities Co., Ltd (ʮ̡)( “ OSC”), Shanghai Jingjujin Investment
Management Partnership (ҳ༟၍ଣΥྫΆุ)( “ 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. 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 the Publicity Department of Shanghai
Municipal Committee (ෂ௅).
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
CEACHC, 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
ึ), and is one of the three largest airline transportation service providers in
China.
CORNERSTONE INVESTORS
– 515 –


--- page 526 ---
The Offer Shares to be allocated and issued to CUAM in its capacity as investment
manager acting as agent on behalf of certain clients, will be held on a discretionary basis for
and on behalf of clients who are Independent Third Parties. As confirmed by CUAM, no
sub-fund is involved in this subscription of Offer Shares under its Cornerstone Investment
Agreement.
Panjing Harbourview Investment Fund
Panjing Harbourview Investment Fund (ږ“() Panjing Fund ”) is an
exempted company incorporated with limited liability in the Cayman Islands under the
Companies Act of the Cayman Islands. Panjing Fund is managed solely by its Investment
Manager, Harbourview Investment Pte. Ltd. (“ Harbourview Investment ”), who holds a
Capital Markets Services Licence issued by the Monetary Authority of Singapore.
Harbourview Investment pursues a long-short investment strategy in managing the assets
of Panjing Fund and focuses on equities which are temporarily under-appreciated by the market
but whose companies display great upside potential. Panjing Fund invests in a diverse portfolio
comprising global listed equity securities and equity-related securities. Panjing Fund’s
investments are not subject to any geographic limitation. XIAO Jian, an Independent Third
Party, is the ultimate beneficial owner of Panjing Fund.
The Offer Shares to be allocated and issued to Panjing Fund in its capacity as investment
manager acting as agent on behalf of certain clients, will be held on a discretionary basis for
and on behalf of clients who are Independent Third Parties. As confirmed by Panjing Fund, no
sub-fund is involved in this subscription of Offer Shares under its Cornerstone Investment
Agreement.
MY Asian Opportunities Master Fund, L.P.
MY Asian Opportunities Master Fund, L.P . (“ MY Asian ”) is a fund established in the
Cayman Islands, which is managed by MY .Alpha Management HK Advisors Limited
(“MY.Alpha ”), a hedge fund manager having a Type 4 (Advising on Securities) license and a
Type 9 (Asset Management) license with the SFC. MY .Alpha is headquartered in Hong Kong
and manages assets on behalf of institutions, endowments, foundations, funds of funds, wealthy
individuals and their families. MY .Alpha’s investment strategy is to invest in Asian companies
using a catalyst-driven, fundamental value approach and to provide consistent, superior
risk-adjusted investment returns relatively independent of the overall market. MY Asian has
over 100 underlying investors and none of those investors hold more than 10% of its interest
in MY Asian.
The Offer Shares will be allocated and issued to MY Asian in its capacity as the
investment holding vehicle, over which MY .Alpha, as its investment manager, has investment
authority on a discretionary basis. As confirmed by MY Asian, the underlying clients of MY
Asian are Independent Third Parties and no sub-fund is involved in this subscription of Offer
Shares under its Cornerstone Investment Agreement.
CORNERSTONE INVESTORS
– 516 –


--- page 527 ---
Emerging Markets Healthcare Partners LLC and Worldwide Healthcare Partners LLC
Emerging Markets Healthcare Partners LLC (“ EMHCP ”) is a Delaware, U.S.,
incorporated hedge fund. The general partner of EMHCP is Exome Asset GP LLC. Exome
Asset Management LLC is the investment manager of EMHCP . Samuel D. Isaly is the ultimate
beneficial owner of Exome Asset GP LLC and Exome Asset Management LLC. EMHCP is held
by more than 30 limited partners and none of the limited partners hold 30% or more interests
in this fund.
Worldwide Healthcare Partners LLC (“ WWHCP ”) is a Delaware, U.S., incorporated
hedge fund. The general partner of WWHCP is Exome Asset GP LLC. Exome Asset
Management LLC is the investment manager of WWHCP . Samuel D. Isaly is the ultimate
beneficial owner of Exome Asset GP LLC and Exome Asset Management LLC. WWHCP is
held by more than 20 limited partners and none of the limited partners hold 30% or more
interests in this fund.
Suzhou Suchuang Biomedical Health Venture Capital Fund Partnership
(Limited Partnership) (ΥྫΆุ(Υྫ))
Suzhou Suchuang Biomedical Health V enture Capital Fund Partnership (Limited
Partnership) (ΥྫΆุ(Υྫ)) (“ Suzhou
Suchuang ”) is a limited liability partnership incorporated in the PRC engaged in investment
activities in biotech and healthcare industry. Suzhou Suchuang had over RMB500 million in
asset under management. Suzhou Suchuang is held as to 0.2% by its general partner, Suzhou
National Development Asset Management Co., Ltd. (ʮ̡)( “ Suzhou
National Development ”). Suzhou National Development is wholly owned by Suzhou National
Development V enture Capital Holdings Co., Ltd. (ʮ̡)( “ Suzhou
National Development Venture ”), which also holds 24.80% economic interest in Suzhou
Suchuang as a limited partner. Suzhou National Development V enture is ultimately controlled
by the Finance Bureau of Suzhou Municipality (҅). Soochow Life Insurance Co.,
Ltd. (ʮ̡)( “ Soochow Life ”), as a limited partner of Suzhou
Suchuang, holds 25% economic interests in Suzhou Suchuang and is ultimately controlled by
the Finance Bureau of Suzhou Municipality (҅). Save as mentioned above, none
of the remaining seven limited partners of Suzhou Suchuang hold more than 20% economic
interest in Suzhou Suchuang.
Suzhou Suchuang has completed the overseas direct investment (“ ODI”) registration and
all relevant procedures pursuant to the applicable ODI Rules in relation to its offshore
investments as a domestic institution.
CORNERSTONE INVESTORS
– 517 –


--- page 528 ---
The table below sets out details of the Cornerstone Placing:
Based on the Offer Price of HK$94.60 (being the low end of the indicative Offer Price
range)
Assuming the Offer Size Adjustment Option
is not exercised
Assuming Offer Size Adjustment Option
is fully exercised
Assuming the
Over-allotment Option
is not exercised
Assuming the
Over-allotment Option
is fully exercised
Assuming the
Over-allotment Option
is not exercised
Assuming the
Over-allotment Option
is fully exercised
Cornerstone
Investors
Investment
amount (1)
Number of
Offer
Shares (2)
Approximate
% of the
Offer Shares
Approximate
% of the
Shares in
issue upon
completion of
the Global
Offering
Approximate
% of the
Offer Shares
Approximate
% of the
Shares in
issue upon
completion of
the Global
Offering
Approximate
% of the
Offer Shares
Approximate
% of the
Shares in issue
upon
completion of
the Global
Offering
Approximate
% of the
Offer Shares
Approximate
% of the
Shares in
issue upon
completion of
the Global
Offering
(US$ in
million)
BioNTech /H1118/H1118/H1118 5.0 410,900 2.73% 0.49% 2.37% 0.48% 2.37% 0.48% 2.06% 0.47%
LA V Star /H1118/H1118/H1118 5.0 410,900 2.73% 0.49% 2.37% 0.48% 2.37% 0.48% 2.06% 0.47%
Lake Bleu
Prime /H1118/H1118/H1118/H11183.2 263,000 1.75% 0.32% 1.52% 0.31% 1.52% 0.31% 1.32% 0.30%
Lake Bleu
Innovation /H1118/H1118 1.8 147,900 0.98% 0.18% 0.85% 0.17% 0.85% 0.17% 0.74% 0.17%
TruMed /H1118/H1118/H1118/H111810.0 821,900 5.45% 0.99% 4.74% 0.96% 4.74% 0.96% 4.12% 0.93%
Fullgoal Fund /H1118 4.8 392,800 2.61% 0.47% 2.27% 0.46% 2.27% 0.46% 1.97% 0.45%
Fullgoal HK /H1118/H1118 5.2 429,100 2.85% 0.52% 2.48% 0.50% 2.48% 0.50% 2.15% 0.49%
E Fund
Management /H1118 7.4 604,900 4.01% 0.73% 3.49% 0.71% 3.49% 0.71% 3.03% 0.69%
E Fund HK /H1118/H1118 0.6 52,600 0.35% 0.06% 0.30% 0.06% 0.30% 0.06% 0.26% 0.06%
CUAM /H1118/H1118/H1118/H11186.0 493,100 3.27% 0.59% 2.84% 0.58% 2.84% 0.58% 2.47% 0.56%
Panjing Fund /H1118/H1118 5.0 410,900 2.73% 0.49% 2.37% 0.48% 2.37% 0.48% 2.06% 0.47%
MY Asian /H1118/H1118/H1118 5.0 410,900 2.73% 0.49% 2.37% 0.48% 2.37% 0.48% 2.06% 0.47%
EMHCP /H1118/H1118/H1118/H11182.5 205,400 1.36% 0.25% 1.19% 0.24% 1.19% 0.24% 1.03% 0.23%
WWHCP /H1118/H1118/H1118 1.5 123,200 0.82% 0.15% 0.71% 0.14% 0.71% 0.14% 0.62% 0.14%
Suzhou
Suchuang /H1118/H1118 2.0 164,300 1.09% 0.20% 0.95% 0.19% 0.95% 0.19% 0.82% 0.19%
Notes:
1. Exclusive of brokerage, the SFC transaction levy, the Stock Exchange trading fee and the AFRC transaction
levy, and to be converted to Hong Kong dollars based on the exchange rate as disclosed in this prospectus.
2. Rounded down to the nearest whole board lot of 100 Shares. Calculated based on the the exchange rate set out
in the section headed “Information about this prospectus and the Global Offering — Exchange Rate
Conversion.”
CORNERSTONE INVESTORS
– 518 –


--- page 529 ---
Based on the Offer Price of HK$98.90 (being the mid-point of the indicative Offer Price
range)
Assuming the Offer Size Adjustment Option
is not exercised
Assuming Offer Size Adjustment Option
is fully exercised
Assuming the
Over-allotment Option
is not exercised
Assuming the
Over-allotment Option
is fully exercised
Assuming the
Over-allotment Option
is not exercised
Assuming the
Over-allotment Option
is fully exercised
Cornerstone
Investors
Investment
amount (1)
Number of
Offer
Shares (2)
Approximate
% of the
Offer Shares
Approximate
% of the
Shares in
issue upon
completion of
the Global
Offering
Approximate
% of the
Offer Shares
Approximate
% of the
Shares in
issue upon
completion of
the Global
Offering
Approximate
% of the
Offer Shares
Approximate
% of the
Shares in
issue upon
completion of
the Global
Offering
Approximate
% of the
Offer Shares
Approximate
% of the
Shares in
issue upon
completion of
the Global
Offering
(US$ in
million)
BioNTech /H1118/H1118/H1118 5.0 393,100 2.61% 0.47% 2.27% 0.46% 2.27% 0.46% 1.97% 0.45%
LA V Star /H1118/H1118/H1118 5.0 393,100 2.61% 0.47% 2.27% 0.46% 2.27% 0.46% 1.97% 0.45%
Lake Bleu
Prime /H1118/H1118/H1118/H11183.2 251,600 1.67% 0.30% 1.45% 0.29% 1.45% 0.29% 1.26% 0.29%
Lake Bleu
Innovation /H1118/H1118 1.8 141,500 0.94% 0.17% 0.82% 0.17% 0.82% 0.17% 0.71% 0.16%
TruMed /H1118/H1118/H1118/H111810.0 786,200 5.22% 0.95% 4.54% 0.92% 4.54% 0.92% 3.94% 0.89%
Fullgoal Fund /H1118 4.8 375,700 2.49% 0.45% 2.17% 0.44% 2.17% 0.44% 1.88% 0.43%
Fullgoal HK /H1118/H1118 5.2 410,500 2.72% 0.49% 2.37% 0.48% 2.37% 0.48% 2.06% 0.47%
E Fund
Management /H1118 7.4 578,600 3.84% 0.70% 3.34% 0.68% 3.34% 0.68% 2.90% 0.66%
E Fund HK /H1118/H1118 0.6 50,300 0.33% 0.06% 0.29% 0.06% 0.29% 0.06% 0.25% 0.06%
CUAM /H1118/H1118/H1118/H11186.0 471,700 3.13% 0.57% 2.72% 0.55% 2.72% 0.55% 2.37% 0.54%
Panjing Fund /H1118/H1118 5.0 393,100 2.61% 0.47% 2.27% 0.46% 2.27% 0.46% 1.97% 0.45%
MY Asian /H1118/H1118/H1118 5.0 393,100 2.61% 0.47% 2.27% 0.46% 2.27% 0.46% 1.97% 0.45%
EMHCP /H1118/H1118/H1118/H11182.5 196,500 1.30% 0.24% 1.13% 0.23% 1.13% 0.23% 0.99% 0.22%
WWHCP /H1118/H1118/H1118 1.5 117,900 0.78% 0.14% 0.68% 0.14% 0.68% 0.14% 0.59% 0.13%
Suzhou
Suchuang /H1118/H1118 2.0 157,200 1.04% 0.19% 0.91% 0.18% 0.91% 0.18% 0.79% 0.18%
Notes:
1. Exclusive of brokerage, the SFC transaction levy, the Stock Exchange trading fee and the AFRC transaction
levy, and to be converted to Hong Kong dollars based on the exchange rate as disclosed in this prospectus.
2. Rounded down to the nearest whole board lot of 100 Shares. Calculated based on the the exchange rate set out
in the section headed “Information about this prospectus and the Global Offering — Exchange Rate
Conversion.”
CORNERSTONE INVESTORS
– 519 –


--- page 530 ---
Based on the Offer Price of HK$103.20 (being the high end of the indicative Offer Price
range)
Assuming the Offer Size Adjustment Option
is not exercised
Assuming Offer Size Adjustment Option
is fully exercised
Assuming the
Over-allotment Option
is not exercised
Assuming the
Over-allotment Option
is fully exercised
Assuming the
Over-allotment Option
is not exercised
Assuming the
Over-allotment Option
is fully exercised
Cornerstone
Investors
Investment
amount (1)
Number of
Offer
Shares (2)
Approximate
% of the
Offer Shares
Approximate
% of the
Shares in
issue upon
completion of
the Global
Offering
Approximate
% of the
Offer Shares
Approximate
% of the
Shares in
issue upon
completion of
the Global
Offering
Approximate
% of the
Offer Shares
Approximate
% of the
Shares in
issue upon
completion of
the Global
Offering
Approximate
% of the
Offer Shares
Approximate
% of the
Shares in
issue upon
completion of
the Global
Offering
(US$ in
million)
BioNTech /H1118/H1118/H1118 5.0 376,700 2.50% 0.45% 2.17% 0.44% 2.17% 0.44% 1.89% 0.43%
LA V Star /H1118/H1118/H1118 5.0 376,700 2.50% 0.45% 2.17% 0.44% 2.17% 0.44% 1.89% 0.43%
Lake Bleu
Prime /H1118/H1118/H1118/H11183.2 241,100 1.60% 0.29% 1.39% 0.28% 1.39% 0.28% 1.21% 0.27%
Lake Bleu
Innovation /H1118/H1118 1.8 135,600 0.90% 0.16% 0.78% 0.16% 0.78% 0.16% 0.68% 0.15%
TruMed /H1118/H1118/H1118/H111810.0 753,400 5.00% 0.91% 4.35% 0.88% 4.35% 0.88% 3.78% 0.86%
Fullgoal Fund /H1118 4.8 360,000 2.39% 0.43% 2.08% 0.42% 2.08% 0.42% 1.81% 0.41%
Fullgoal HK /H1118/H1118 5.2 393,300 2.61% 0.47% 2.27% 0.46% 2.27% 0.46% 1.97% 0.45%
E Fund
Management /H1118 7.4 554,500 3.68% 0.67% 3.20% 0.65% 3.20% 0.65% 2.78% 0.63%
E Fund HK /H1118/H1118 0.6 48,200 0.32% 0.06% 0.28% 0.06% 0.28% 0.06% 0.24% 0.05%
CUAM /H1118/H1118/H1118/H11186.0 452,000 3.00% 0.54% 2.61% 0.53% 2.61% 0.53% 2.27% 0.51%
Panjing Fund /H1118/H1118 5.0 376,700 2.50% 0.45% 2.17% 0.44% 2.17% 0.44% 1.89% 0.43%
MY Asian /H1118/H1118/H1118 5.0 376,700 2.50% 0.45% 2.17% 0.44% 2.17% 0.44% 1.89% 0.43%
EMHCP /H1118/H1118/H1118/H11182.5 188,300 1.25% 0.23% 1.09% 0.22% 1.09% 0.22% 0.94% 0.21%
WWHCP /H1118/H1118/H1118 1.5 113,000 0.75% 0.14% 0.65% 0.13% 0.65% 0.13% 0.57% 0.13%
Suzhou
Suchuang /H1118/H1118 2.0 150,600 1.00% 0.18% 0.87% 0.18% 0.87% 0.18% 0.76% 0.17%
Notes:
1. Exclusive of brokerage, the SFC transaction levy, the Stock Exchange trading fee and the AFRC transaction
levy, and to be converted to Hong Kong dollars based on the exchange rate as disclosed in this prospectus.
2. Rounded down to the nearest whole board lot of 100 Shares. Calculated based on the the exchange rate set out
in the section headed “Information about this prospectus and the Global Offering — Exchange Rate
Conversion.”
CORNERSTONE INVESTORS
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CONDITIONS PRECEDENT
The obligations of each Cornerstone Investor to subscribe for the Offer Shares under the
respective Cornerstone Investment Agreements are subject to, among others, the following
closing conditions:
(a) the underwriting agreements for the Hong Kong Public Offering and the
International Offering 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 these underwriting agreements, and neither of the aforesaid
underwriting agreements having been terminated;
(b) the Offer Price having been agreed upon between the Company and the Joint
Representatives (for themselves and on behalf of the Capital Market Intermediaries
and the Underwriters);
(c) the Listing Committee of Stock Exchange having granted the listing of, and
permission to deal in, the Shares in issue, the Shares to be issued pursuant to the
Global Offering (including the Shares under the Cornerstone Placing as well as other
applicable waivers and consents and any Shares that may be issued under the
Offer-size Adjustment Option and the Over-allotment Option) and such approval,
permission, waivers or consents having not been revoked prior to the
commencement of dealings in the Shares on the Stock Exchange;
(d) no laws or regulations shall have been enacted or promulgated by any governmental
authority which prohibits the consummation of the transactions contemplated in the
Global Offering or the Cornerstone Investment Agreements, and there shall be no
orders or injunctions from a court of competent jurisdiction in effect precluding or
prohibiting consummation of such transactions; and
(e) the respective representations, warranties, undertakings, confirmations of the
Cornerstone Investors under the respective Cornerstone Investment Agreements are
(as of the date of the Cornerstone Investment Agreements) and shall be (as of the
Listing Date) accurate and true in all material respects and not misleading and that
there is no material breach of any of the Cornerstone Investment Agreements on the
part of their respective Cornerstone Investors.
CORNERSTONE INVESTORS
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--- page 532 ---
RESTRICTIONS ON THE CORNERSTONE INVESTORS
Each of the Cornerstone Investors has agreed that without the prior written consent of
each of our Company, the Joint Representatives and the Joint Sponsors, it will not, whether
directly or indirectly, at any time during the period of six months starting from and inclusive
of the Listing Date (the “ Lock-up Period ”), dispose of, in any way, any of the Offer Shares
or any interest in any company or entity holding such Offer Shares, save for certain limited
circumstances, such as transfers to any of its wholly-owned subsidiaries who will be bound by
the same obligations of such Cornerstone Investors, including the Lock-up Period restriction.
CORNERSTONE INVESTORS
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--- page 533 ---
FUTURE PLANS AND PROSPECTS
See “Business — Our Business Strategies” for a detailed description of our future plans.
USE OF PROCEEDS
We estimate that we will receive net proceeds from the Global Offering of approximately
HK$1,370.3 million, after deducting underwriting commissions, fees and estimated expenses
payable by us in connection with the Global Offering, and assuming an Offer Price of
HK$98.90 per Share, being the mid-point of the indicative Offer Price range stated in this
prospectus. If the Offer Price is set at HK$103.20 per Share, being the high end of the
indicative Offer Price range, the net proceeds from the Global Offering will increase by
approximately HK$61.9 million. If the Offer Price is set at HK$94.60 per Share, being the low
end of the indicative Offer Price range, the net proceeds from the Global Offering will decrease
by approximately HK$61.9 million.
Assuming an Offer Price at the mid-point of the indicative Offer Price range and that the
Offer Size Adjustment Option and the Over-allotment Option are not exercised, we currently
intend to apply these net proceeds for the following purposes:
 Approximately 45.0%, or HK$616.6 million, will be used for the research,
development and commercialization of our Core Products, namely, DB-1303 and
DB-1311 in our retained territory:
— approximately 20.0%, or HK$274.1 million, will be used for the ongoing and
planned clinical trials of DB-1303/BNT323, including approximately 5.0%, or
HK$68.5 million for HER2-expressing EC, approximately 7.0%, or HK$95.9
million for HR+/HER2-low BC, approximately 5.0%, or HK$68.5 million for
HER2+ BC (2L+), approximately 2.0%, or HK$27.4 million for HER2+ BC
(1L, in combination with Pertuzumab) and approximately 1.0%, or HK$13.7
million for other solid tumors such as OC, CRC and esophageal cancer;
For details of DB-1303’s clinical development plan, see “Business — Our
Pipeline — Overview” and “Business — Our Pipeline — ADC Assets
Developed from DITAC Technology Platform — DB-1303/BNT323, a late
clinical stage HER2 ADC candidate, our Core Product — Clinical
Development Plan.” For the competitive landscape of HER2 ADCs, see
“Business — Our Pipeline — ADC Assets Developed from DITAC Technology
Platform — DB-1303/BNT323, a late clinical stage HER2 ADC candidate, our
Core Product — Market Opportunity and Competition.”
We anticipate using over 70% of the proceeds allocated for the ongoing and
planned clinical trials of DB-1303 within 24 months following the Listing.
FUTURE PLANS AND USE OF PROCEEDS
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--- page 534 ---
— approximately 20.0%, or HK$274.1 million, will be used for the ongoing and
planned clinical trials of DB-1311/BNT324, including approximately 8.0%, or
HK$109.6 million for SCLC, approximately 8.0%, or HK$109.6 million for
CRPC, approximately 2.0%, or HK$27.4 million for ESCC and approximately
2.0%, or HK$27.4 million for other solid tumors such as NSCLC;
For details of DB-1311’s clinical development plan, see “Business — Our
Pipeline — Overview” and “Business — Our Pipeline — ADC Assets
Developed from DITAC Technology Platform — DB-1311/BNT324, a B7-H3
ADC candidate with global market potential, our Core Product — Clinical
Development Plan.” For the competitive landscape of B7-H3 ADCs, see
“Business — Our Pipeline — ADC Assets Developed from DITAC Technology
Platform — DB-1311/BNT324, a B7-H3 ADC candidate with global market
potential, our Core Product — Market Opportunity and Competition.”
We anticipate using over 50% of the proceeds allocated for the ongoing and
planned clinical trials of DB-1311 within 24 months following the Listing.
— approximately 5.0%, or HK$68.5 million, will be used for the
commercialization, registration filings and other regulatory matters for DB-
1303 and DB-1311;
We anticipate using over 80% of the proceeds allocated for the
commercialization, registration filings and other regulatory matters for DB-
1303 and DB-1311 within 24 months following the Listing.
 Approximately 30.0%, or HK$411.1 million, will be used for the research and
development of our key products, including:
— approximately 12.5%, or HK$171.3 million, will be used for the ongoing and
planned clinical trials for DB-1310, including approximately 5.0%, or
HK$68.5 million for EGFRm NSCLC, approximately 1.5%, or HK$20.6
million for KRASm NSCLC, approximately 4.5%, or HK$61.7 million for
HER2-expressing BC and approximately 1.5%, or HK$20.6 million for other
solid tumors, such as CRPC, HNSCC, ESCC and BTC;
For details of DB-1310’s clinical development plan, see “Business — Our
Pipeline — Overview” and “Business — Our Pipeline — ADC Assets
Developed from DITAC Technology Platform — DB-1310, a HER3 ADC
candidate in phase 1/2a trial, our Key Product — Next Steps.” For the
competitive landscape of HER3 ADCs, see “Business — Our Pipeline — ADC
Assets Developed from DITAC Technology Platform — DB-1310, a HER3
ADC candidate in phase 1/2a trial, our key product — Market Opportunity and
Competition.”
We anticipate using over 80% of the proceeds allocated for the ongoing and
planned clinical trials for DB-1310 within 24 months following the Listing.
FUTURE PLANS AND USE OF PROCEEDS
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--- page 535 ---
— approximately 7.5%, or HK$102.8 million, will be used for the ongoing and
planned clinical trials for DB-1305/BNT325, in our retained territory,
including approximately 3.5%, or HK$48.0 million for OC, approximately
0.5%, or HK$6.9 million for NSCLC (2L+), and approximately 3.0%, or
HK$41.1 million for other solid tumors, and approximately 0.5%, or HK$6.9
million for combination studies in NSCLC, OC, CC and TNBC patients;
For details of DB-1305’s clinical development plan, see “Business — Our
Pipeline — Overview.” For the competitive landscape of TROP2 ADCs, see
“Business — Our Pipeline — ADC Assets Developed from DITAC Technology
Platform — DB-1305/BNT325, a TROP2 ADC candidate with potential as a
frontline backbone therapy, our key product — Market Opportunity and
Competition.”
We anticipate using over 60% of the proceeds allocated for the ongoing and
planned clinical trials for DB-1305 within 24 months following the Listing.
— approximately 5.0%, or HK$68.5 million, will be used to advance the ongoing
and planned clinical trials for DB-1419;
For details of DB-1419’s clinical development plan, see “Business — Our
Pipeline — Overview” and “Business — Our Pipeline — ADC Assets
Developed from DIBAC Technology Platform — DB-1419, Innovative B7-
H3xPD-L1 BsADC Candidate — Next Steps.” For the competitive landscape
of BsADCs, see “Industry Overview — Overview of Bispecific ADCs.”
We anticipate using over 80% of the proceeds allocated for the clinical
development of DB-1419 within 24 months following the Listing.
— approximately 5.0%, or HK$68.5 million, will be used to advance the clinical
development of DB-2304 for SLE and CLE. We have obtained IND approvals
from the FDA and NMPA for DB-2304 and expect to complete DB-2304’s
phase 1 global trial in 2026;
For details of DB-2304’s clinical development plan, see “Business — Our
Pipeline — Overview” and “Business — Our Pipeline — ADC Assets
Developed from DIMAC Technology Platform — DB-2304, Innovative
Autoimmune ADC for SLE/CLE, our Key Product — Next Steps.” For the
competitive landscape of ADCs for autoimmune diseases, see “Business —
Our Pipeline — ADC Assets Developed from DITAC Technology Platform —
DB-2304, Innovative Autoimmune ADC for SLE/CLE, our Key Product —
Market Opportunity and Competition.”
We anticipate using over 80% of the proceeds allocated for the clinical
development of DB-2304 within 24 months following the Listing.
FUTURE PLANS AND USE OF PROCEEDS
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--- page 536 ---
 Approximately 15.0%, or HK$205.5 million, will be used to fund the continued
development of our ADC technology platforms, advance our other pipeline assets,
and explore and develop new drug assets; and
Our research in the next few years will focus on novel payloads and linkers to
broaden the therapeutic index of our ADCs. We are actively exploring new
mechanism of action and formats to achieve new heights in terms of safety, potency
and activity, and have a number of prototypes under development with promising
broad-spectrum anti-tumor activity and potent bystander killing effects. We believe
these innovations will redefine ADC functionality and chart the course for a new
revolution of the ADC modality. In addition, we plan to leverage the power of AI to
systematically optimize every stage of our R&D, from target identification, ADC
design and engineering to biomarker discovery, enabling us to fine-tune our
engineering of next generation ADC candidates to prioritize high-potential targets
and indications. For details on our strategies on ADC technology innovation, see
“Business — Our Business Strategies — Continue technology innovation to unlock
the full potential of ADCs and disrupt treatment landscape.”
We anticipate using over 80% of the proceeds allocated to fund the continued
development of our ADC technology platforms, advance our other pipeline assets,
and explore and develop new drug assets within 24 months following the Listing.
 Approximately 10.0%, or HK$137.0 million, will be used for working capital and
other general corporate purposes.
The above allocation of the net proceeds from the Global Offering will be adjusted on a
pro rata basis in the event that the Offer Price is fixed at a higher or lower level compared to
the mid-point of the indicative Offer Price range stated in this prospectus.
If the Offer Size Adjustment Option and the Over-allotment Option are exercised in full,
the net proceeds that we will receive will be approximately HK$1,829.3 million, assuming an
Offer Price of HK$98.90 per Share (being the mid-point of the indicative Offer Price range).
In the event that the Offer Size Adjustment Option and the Over-allotment Option are exercised
in full, we intent to apply the additional net proceeds to the above purposes in the proportions
stated above.
To the extent that the net proceeds from the Global Offering are not immediately used for
the purposes described above and to the extent permitted by the relevant laws and regulations,
they will be placed in short-term interest-bearing accounts at licensed commercial banks and/
or other authorized financial institutions (as defined under the Securities and Futures
Ordinance or the applicable laws and regulations in other jurisdictions).
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
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--- page 537 ---
HONG KONG UNDERWRITERS
Morgan Stanley Asia Limited
Jefferies Hong Kong Limited*
CLSA Limited*
China International Capital Corporation Hong Kong Securities Limited
CMB International Capital Limited
ICBC International Securities Limited
BOCI Asia Limited
GF Securities (Hong Kong) Brokerage Limited
ABCI Securities Company Limited
(* in no particular order)
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. If, for any reason, the Offer Price is not agreed between the Joint
Representatives (on behalf of the Underwriters) and the Company, the Global Offering will not
proceed and will lapse.
The Global Offering comprises the Hong Kong Public Offering of initially 1,507,200
Hong Kong Offer Shares and the International Offering of initially 13,564,400 International
Offer Shares, subject, in each case, to reallocation on the basis as described in the section
headed “Structure of the Global Offering” in this prospectus as well as to the Offer Size
Adjustment Option and/or the Over-allotment Option (in the case of the International
Offering).
UNDERWRITING
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--- page 538 ---
UNDERWRITING ARRANGEMENTS AND EXPENSES
Hong Kong Public Offering
Hong Kong Underwriting Agreement
Pursuant to the Hong Kong Underwriting Agreement, the Company is offering the Hong
Kong Offer Shares for subscription 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 Shares in issue, the Shares to be issued pursuant to the Global Offering
(including the Shares which may be issued upon the exercise of the Offer Size Adjustment
Option and the Over-allotment Option and any Shares to be issued pursuant to the Pre-IPO
Share Equity Incentive Plan) on the Main Board of the Stock Exchange and such approval not
having been subsequently revoked prior to the commencement of trading of the 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.
Grounds for termination
If any of the events set out below occur at any time prior to 8:00 a.m. on the Listing Date,
the Joint Sponsors and the Joint Representatives (for themselves and on behalf of the Hong
Kong Underwriters) shall be entitled by notice to the Company to terminate the Hong Kong
Underwriting Agreement with immediate effect:
(a) there develops, occurs, exists or comes into effect:
(i) any event, or series of events, 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, epidemic, pandemic, large
scale outbreaks of diseases or its escalation, mutation or aggravation
(including, without limitation, SARS, swine or avian flu, H5N1, H1N1, H7N9,
contagious coronavirus (COVID-19) and such related/mutated forms), accident
or interruption or delay in transportation, economic sanctions, strikes, labour
disputes, lock-outs, fire, explosion, flooding, tsunami, earthquake, volcanic
eruption, civil commotion, riots, rebellion, public disorder, acts of war,
UNDERWRITING
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--- page 539 ---
outbreak or escalation of hostilities (whether or not war is declared), acts of
God or acts of terrorism (whether or not responsibility has been claimed)) in
or affecting Hong Kong, the PRC, the Cayman Islands, the BVI, the United
States, Singapore, the United Kingdom or the European Union (or any member
thereof) or any other jurisdiction relevant to the Group (collectively, the
“Relevant Jurisdictions ”);
(ii) any change or development involving a prospective change, or any event or
circumstances or series of events likely to result in any change or development
involving a prospective change, in any local, national, regional or international
financial, economic, political, military, industrial, legal, fiscal, regulatory,
currency, credit or market matters or conditions, equity securities or exchange
control or any monetary or trading settlement system or other financial markets
(including, without limitation, conditions in the stock and bond markets,
money and foreign exchange markets, the interbank markets and credit
markets), in or affecting any of the Relevant Jurisdictions;
(iii) any moratorium, suspension or restriction (including, without limitation, any
imposition of or requirement for any minimum or maximum price limit or price
range) in or on trading in securities generally on the Stock Exchange, the New
Y ork Stock Exchange, the NASDAQ Global Market, the London Stock
Exchange, the Shanghai Stock Exchange, the Shenzhen Stock Exchange,
Singapore Stock Exchange or the Tokyo Stock Exchange;
(iv) any general moratorium on commercial banking activities in Hong Kong
(imposed by the Financial Secretary or the Hong Kong Monetary Authority or
other competent authority), New Y ork (imposed at the U.S. Federal or New
Y ork State level or by any other competent authority), London, the PRC, the
European Union (or any member thereof), Japan, Singapore or any of the
Relevant Jurisdictions (declared by the relevant authorities) or any disruption
in commercial banking or foreign exchange trading or securities settlement or
clearance services, procedures or matters in or affecting any of the Relevant
Jurisdictions;
(v) any new law or regulation or any change or any development involving a
prospective change or any event or circumstance likely to result in a change or
a development involving a prospective change in existing laws or regulations
or any change or development involving a prospective change in the
interpretation or application thereof by any court or any governmental
authority in or affecting any of the Relevant Jurisdictions;
(vi) the imposition of sanctions, or the withdrawal of trading privileges, in
whatever form, directly or indirectly, by any authority that is relevant to the
business operations of any member of the Group;
UNDERWRITING
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--- page 540 ---
(vii) any change or development involving a prospective change or amendment in
or affecting taxation or foreign exchange control, currency exchange rates or
foreign investment regulations (including, without limitation, a material
devaluation of the Hong Kong dollar or RMB against any foreign currencies,
a change in the system under which the value of the Hong Kong dollar is linked
to that of the United States dollar or RMB is linked to any foreign currency or
currencies), or the implementation of any exchange control, in any of the
Relevant Jurisdictions or adversely affecting an investment in the Offer Shares;
(viii) a Director or a member of the Group’s senior management as named in this
prospectus 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;
(ix) other than with the prior written consent of the Joint Sponsors and Joint
Representatives, the issue or requirement to issue by the Company of a
supplement or amendment to this prospectus, the Preliminary Offering
Circular, the Final Offering Circular 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;
(x) a valid demand by any creditor for repayment or payment of any material
indebtedness of any member of the Group or in respect of which any member
of the Group is liable prior to its stated maturity;
(xi) there is any order or petition for the winding-up of any member of the Group
(other than the Company and members of the Group set out in (b)(xv) below)
or any composition or arrangement made by any member of the Group (other
than the Company and members of the Group set out in (b)(xv) below) with its
creditors or a scheme of arrangement entered into by any member of the Group
or any resolution for the winding-up of any member of the Group or the
appointment of a provisional liquidator, receiver or manager over all or part of
the material assets or undertaking of any member of the Group or anything
analogous thereto occurring in respect of any member of the Group;
(xii) an authority or a political body or organization in any Relevant Jurisdiction
commencing any investigation or other action, or announcing an intention to
investigate or take other action, against any Director or members of senior
management;
(xiii) any litigation, dispute, legal action or claim of any third party or regulatory,
administrative investigation or action being threatened, instigated or
announced against any member of the Group;
(xiv) any contravention by the Company, any member of the Group, or any Directors
of any applicable laws and regulations including the Listing Rules; or
(xv) any change or development involving a prospective change in, or a
materialization of, any of the risks set out in the section headed “Risk Factors”
of this prospectus;
UNDERWRITING
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--- page 541 ---
which, individually or in the aggregate, in the sole and absolute opinion of the Joint
Sponsors and the Joint Representatives (for themselves and on behalf of the Hong
Kong Underwriters):
(1) has or will or may have a material adverse effect on the assets, liabilities,
general affairs, business, management, prospects, shareholders’ equity, profit,
losses, earnings, results of operations, performance, position or condition,
financial or otherwise, of the Group as a whole;
(2) has or will have or may have a material adverse effect on the success or
marketability of the Global Offering or the level of applications or the
distribution of the Offer Shares under the Hong Kong Public Offering or the
level of interest under the International Offering;
(3) makes or will make or is likely to make it inadvisable, inexpedient,
impracticable or incapable for the Hong Kong Public Offering and/or the
International 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 this document; 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 Joint Sponsors and the Joint Representatives (for
themselves and on behalf of the Hong Kong Underwriters) that:
(i) any statement contained in the Offering Documents, the Operative Documents,
the Preliminary Offering Circular, and/or any notices, announcements,
advertisements, communications or other documents (including any
announcement, circular, document or other communication pursuant to the
Hong Kong Underwriting Agreement) issued or used by or on behalf of the
Company in connection with the Hong Kong Public Offering and the Global
Offering (including any supplement or amendment thereto) (the “ Offer-
Related Documents ”) was, when it was issued, or has become, untrue,
incorrect, inaccurate, incomplete in any material respects or misleading or
deceptive, or that any estimate, forecast, expression of opinion, intention or
expectation contained in any of such documents issued or used by or on behalf
of the Company in connection with the Global Offering was, when it was
issued, or has become unfair or misleading in any respect or based on untrue,
dishonest or unreasonable assumptions;
UNDERWRITING
– 531 –


--- page 542 ---
(ii) any matter has arisen or has been discovered which would, had it arisen or been
discovered immediately before the date of this document, constitute a material
omission from, or misstatement in, any of the Offer-Related Documents;
(iii) there is a material breach of any of the obligations imposed upon the Company
under the Hong Kong Underwriting Agreement or the International
Underwriting Agreement or any of the Cornerstone Agreements, as applicable;
(iv) there is an event, act or omission which gives or is likely to give rise to any
material liability of the Company pursuant to the indemnities given by any of
them under the Hong Kong Underwriting Agreement or the International
Underwriting Agreement, as applicable;
(v) there is any material adverse change, or development or likely to be any
prospective material adverse change or development in the assets, liabilities,
general affairs, business, management, prospects, shareholders’ equity, profits,
losses, earnings, solvency, liquidity position, funding, results of operations,
performance, position or condition, financial or otherwise, of the Group as a
whole;
(vi) there is a breach of, or any event or circumstance rendering untrue, incorrect,
incomplete or misleading in any respect, any of the warranties given by the
Company in the Hong Kong Underwriting Agreement or the International
Underwriting Agreement, as applicable;
(vii) the approval of the Listing Committee of the listing of, and permission to deal
in, the Shares in issue and the Shares to be issued pursuant to the Global
Offering (including the additional Shares which may be issued upon 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;
(viii) any person has withdrawn or is subject to withdrawing its consent to the issue
of this document 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;
(ix) the Company withdraws this document (and/or any other documents issued or
used in connection with the Global Offering) or the Global Offering;
UNDERWRITING
– 532 –


--- page 543 ---
(x) a material portion of the orders placed or confirmed in the bookbuilding
process, or of the investment commitments made by any cornerstone investors
under agreements signed with such cornerstone investors, have been
withdrawn, terminated or cancelled, or any of the cornerstone investment
agreements is terminated;
(xi) there is a prohibition by any authority applicable to the Company, any of the
Underwriters, and/or any of the foregoing’s respective affiliates, for whatever
reason from offering, allotting, issuing or selling any of the Offer Shares
(including any additional Shares to be issued pursuant to the Offer Size
Adjustment Option and the Over-allotment Option) pursuant to the terms of the
Global Offering;
(xii) any material non-compliance of this prospectus, the CSRC Filings (or any
other documents used in connection with the contemplated subscription and
sale of the Offer Shares) or any aspect of the Global Offering with the Listing
Rules, the CSRC Rules or any other applicable laws;
(xiii) the Chief Executive Officer, or any director or members of senior management
of the Company is vacating her/his office;
(xiv) any Director or member of senior management of the Company is being
charged with an indictable offence or is prohibited by operation of law or
otherwise disqualified from taking part in the management of a company or
there is the commencement by any authority, governmental, political or
regulatory body of any investigation or other action against any Director in his
or her capacity as such or any member of the Group or an announcement by any
authority, governmental, political or regulatory body that it intends to
commence any such investigation or take any such action; or
(xv) there is any order or petition for the winding-up of the Company, Duality
Biologics (Suzhou) Co., Ltd., Duality Biologics (Shanghai) Co., Ltd. and
DualityBio Inc. or any composition or arrangement made by the Company with
its creditors or a scheme of arrangement entered into by any member of the
Group or any resolution for the winding-up of any member of the Group or the
appointment of a provisional liquidator, receiver or manager over all or part of
the material assets or undertaking of any member of the Group or anything
analogous thereto occurring in respect of any member of the Group.
UNDERWRITING
– 533 –


--- page 544 ---
Undertakings by the Company pursuant to the Listing Rules
Pursuant to Rule 10.08 of the Listing Rules, the Company has undertaken to the Stock
Exchange that it will not exercise its power to issue any further Shares, or securities
convertible into equity securities of the 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, the exercise of 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.
Lock-up Undertakings of All Existing Shareholders
Each of our Shareholders as of the date of this prospectus entered into a lock-up
undertaking pursuant to which, for a period ending on, and including, the date falling six
months after the Listing Date (the “ Lock-up Period ”), they would not (i) offer, pledge, charge,
sell, contract or agree to 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, grant or agree to grant any option, right or warrant to purchase or subscribe for,
lend or otherwise 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 in any of the foregoing (the “ Relevant Shares ”); (ii) enter into any swap or any
other arrangement that transfers to another, in whole or in part, any of the economic
consequences of ownership of, any Relevant Shares; (iii) enter into any transaction with the
same economic effect as any transaction described in (i) or (ii) above; or (iv) offer to or
contract to or agree to or publicly disclose that they will or may enter into any transaction
described in (i), (ii) or (iii) above, subject to certain exceptions.
Undertakings pursuant to the Hong Kong Underwriting Agreement
Undertakings by the Company
The Company has undertaken to each of the Joint Global Coordinators, the Sponsor-
Overall Coordinators, the Joint Representatives, the Overall Coordinators, the Joint
Bookrunners, the Joint Lead Managers, the Capital Market Intermediaries, the Hong Kong
Underwriters and the Joint Sponsors that (save for the issue, offer or sale of the Offer Shares
by the Company pursuant to the Global Offering (including pursuant to the Offer Size
Adjustment Option and the Over-allotment Option)), the Company will not, and will procure
each other member of the Group not to without the prior written consent of the Joint Sponsors
and the Joint Representatives (for themselves and on behalf of the Hong Kong Underwriters)
and unless in compliance with the requirements of the Listing Rules, at any time during the
period commencing on the date of the Hong Kong Underwriting Agreement and ending on, and
including, the date that is six months after the Listing Date (the “ First Six-Month Period ”):
(i) offer, allot, issue, sell, accept subscription for, contract to allot, issue or sell,
contract or agree to allot, issue or sell, assign, grant or sell any option, warrant, right
or contract to purchase, purchase any option or contract to sell, grant or agree to
UNDERWRITING
– 534 –


--- page 545 ---
grant any option, right or warrant to purchase or subscribe for, 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 any Shares or other
equity and equity-linked securities of the Company, or any shares or other securities
of such other member of the Group, as applicable, or any interests in any of the
foregoing (including, but not limited to, any securities that are 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 other securities of such other
member of the Group, as applicable), or deposit any Shares or other securities of the
Company or any shares or other securities of such other member of the Group, as
applicable, 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 subscription or ownership (legal or
beneficial) of any Shares or other equity and equity-linked securities of the
Company or any shares or other equity and equity-linked securities of such other
members of Group, as applicable, or any interest therein (including, without
limitation, any securities of which are convertible into or exchangeable or
exercisable for, or represent the right to receive, or any warrants or other rights to
purchase, any Shares or any shares of such other member of the Group, as
applicable); or
(iii) enter into any transaction with the same economic effect as any transaction
described in paragraphs (i) or (ii) above; or
(iv) offer to or contract to or agree to announce, or publicly disclose that the Company
will or may enter into any intention to effect any transaction described in paragraphs
(i), (ii) or (iii) above, in each case, whether any such transaction described in
paragraphs (i), (ii) or (iii) above is to be settled by delivery of Shares or other equity
and equity-linked securities of the Company or shares or other equity and
equity-linked securities of such other member of the Group, as applicable, in cash
or otherwise (whether or not the issue of such Shares or other equity and
equity-linked securities of will be completed within the First Six-Month Period).
In the event that, during the period of six months commencing on the date on which the
First Six-Month Period expires (the “ Second Six-Month Period ”), the Company enters into
any such transactions or offers to or agrees to or contracts to or announces, or publicly
discloses, any intention to, enter into any such transactions, the Company shall take all
reasonable steps to ensure that it will not create a disorderly or false market in the securities
of the Company.
UNDERWRITING
– 535 –


--- page 546 ---
Hong Kong Underwriters’ interests in the 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 the 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 the Group.
Following the completion of the Global Offering, the Hong Kong Underwriters and their
affiliated companies may hold a certain portion of the Shares as a result of fulfilling their
respective obligations under the Hong Kong Underwriting Agreement.
International Offering
International Underwriting Agreement
In connection with the International Offering, the Company expects to enter into the
International Underwriting Agreement with the International Underwriters on the Price
Determination Date. 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 initially being offered pursuant to 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, the Global Offering will not
proceed. See “Structure of the Global Offering — The International Offering.”
Offer Size Adjustment Option
The Company is expected to grant to the International Underwriters the Offer Size
Adjustment Option, exercisable by the Joint Representatives (for themselves and on behalf of
the International Underwriters) on or before the second Business Day prior to the Listing Date
and will lapse immediately thereafter, whichever is earlier, in writing, to require the Company
to allot and issue up to an aggregate of 2,260,700 additional Shares, representing
approximately 15% of the Offer Shares initially available under the Global Offering, at the
same price per Share under the International Offering to cover, among other things, any excess
demand in the International Offering at the absolute discretion of the Joint Representatives.
The Offer Size Adjustment Option provides flexibility for the Joint Representatives 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
– 536 –


--- page 547 ---
Over-allotment Option
The Company is expected to grant to the International Underwriters the Over-allotment
Option, exercisable by the Joint Representatives (for themselves and on behalf of 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, pursuant to which the Company
may be required to issue up to an aggregate of 2,260,700 additional 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 2,599,800
additional Shares (representing not more than 15% of the Offer Shares being offered under the
Global Offering assuming the Offer Size Adjustment Option is exercised in full) at the Offer
Price, to 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 3.0% of the aggregate Offer Price of all the Offer Shares (including any Offer
Shares to be issued pursuant to the exercise of the Offer Size Adjustment Option and the
Over-allotment Option), out of which they will pay any sub-underwriting commissions and
other fees.
The Company may pay to any or all of the Capital Market Intermediaries a discretionary
incentive fee of up to but not exceeding 1.5% of the Offer Price for all the Offer Shares
(including any Offer Shares to be issued pursuant to the exercise of the Offer Size Adjustment
Option and the Over-allotment Option).
Assuming full payment of discretionary incentive fees, the fixed fees and discretionary
fees payable to the Underwriters represent approximately 53.33% and 46.67%, respectively, of
the aggregated fees payable to the Underwriters in connection with the Global Offering.
For any unsubscribed Hong Kong Offer Shares reallocated to the International Offering,
the underwriting commission will not be paid to the Hong Kong Underwriters but will instead
be paid, at the rate applicable to the International Offering, to the relevant International
Underwriters.
Assuming an Offer Price of HK$98.90 per Offer Share (which is the mid-point of the
Offer Price range), the aggregate underwriting commissions and fees together with the Stock
Exchange listing fees, SFC transaction levy, Stock Exchange trading fee and AFRC transaction
levy, legal and other professional fees and printing and all other expenses relating to the Global
Offering (collectively, the “ Commissions and Fees ”) are estimated to be approximately
HK$120.3 million (assuming the Offer Size Adjustment Option and the Over-allotment Option
are not exercised and no Shares are issued pursuant to the Pre-IPO Equity Incentive Plan).
UNDERWRITING
– 537 –


--- page 548 ---
Indemnity
The Company has agreed to indemnify the Joint Sponsors, the Sponsor-Overall
Coordinators, the Joint Global Coordinators, the Joint Representatives, the Overall
Coordinators, the Joint Bookrunners, the Joint Lead Managers, the Capital Market
Intermediaries and the Hong Kong Underwriters for certain losses which they may suffer or
incur, including losses arising from their performance of their obligations under the Hong Kong
Underwriting Agreement and any breach by the Company 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 the Company
and/or persons and entities with relationships with the Company and may also include swaps
and other financial instruments entered into for hedging purposes in connection with the
Group’s loans and other debt.
In relation to the Shares, the activities of the Syndicate Members and their affiliates could
include acting as agent for buyers and sellers of the Shares, entering into transactions with
those buyers and sellers in a principal capacity, including as a lender to initial purchasers of
the Shares (which financing may be secured by the Shares) in the Global Offering, proprietary
trading in the 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
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 Shares, which may have a negative impact
on the trading price of the 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 Shares, in baskets of securities or indices including the Shares, in units
of funds that may purchase the Shares, or in derivatives related to any of the foregoing.
UNDERWRITING
– 538 –


--- page 549 ---
In relation to issues by Syndicate Members or their affiliates of any listed securities
having the 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 Shares in most cases.
All such activities may occur both during and after the end of the stabilizing period
described in the section headed “Structure of the Global Offering” in this prospectus. Such
activities may affect the market price or value of the Shares, the liquidity or trading volume
in the Shares and the volatility of the price of the 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 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 the
Company and each of 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
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--- page 550 ---
THE GLOBAL OFFERING
This prospectus is published in connection with the Hong Kong Public Offering as part
of the Global Offering.
The listing of the Shares on the Stock Exchange is sponsored by the Joint Sponsors. The
Joint Sponsors have made an application on behalf of the Company to the Stock Exchange for
the listing of, and permission to deal in, the Shares in issue and to be issued as mentioned in
this prospectus.
15,071,600 Offer Shares will initially be made available under the Global Offering
comprising:
(a) the Hong Kong Public Offering of initially 1,507,200 Shares (subject to
reallocation) in Hong Kong as described in “— The Hong Kong Public Offering” in
this section below; and
(b) the International Offering of initially 13,564,400 Shares (subject to reallocation, the
Offer Size Adjustment Option and the Over-allotment Option) (i) in the United
States solely to QIBs in reliance on Rule 144A or another exemption from, or in a
transaction not subject to, the registration requirements of the U.S. Securities Act
and (ii) outside the United States (including to professional and institutional
investors within Hong Kong) in offshore transactions in reliance on Regulation S, as
described in the sub-section headed “— The International Offering” in this section
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 18.12% 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 and without taking into
account any Shares to be issued pursuant to the Pre-IPO Equity Incentive Plan. If the
Over-allotment Option is exercised in full but no Shares are issued pursuant to the Pre-IPO
Equity Incentive Plan, the Offer Shares (including Shares issued pursuant to the full exercise
of the Over-allotment Option) will represent approximately 20.29% of the total Shares in issue
(assuming the Offer Size Adjustment Option is not exercised at all) or approximately 22.64%
of the total Shares in issue (assuming the Offer Size Adjustment Option is exercised in full)
immediately following the completion of the Global Offering and the issue of Offer Shares
pursuant to the Over-allotment Option.
References in this prospectus to applications, application monies or the procedure for
applications relate solely to the Hong Kong Public Offering.
STRUCTURE OF THE GLOBAL OFFERING
– 540 –


--- page 551 ---
THE HONG KONG PUBLIC OFFERING
Number of Offer Shares Initially Offered
The Company is initially offering 1,507,200 Shares for subscription by the public in Hong
Kong at the Offer Price, representing approximately 10% of the total number of Offer Shares
initially available under the Global Offering. The number of Offer Shares initially offered
under the Hong Kong Public Offering, subject to any reallocation of Offer Shares between the
International Offering and the Hong Kong Public Offering, will represent approximately 1.81%
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
and no Shares are issued pursuant to the Pre-IPO Equity Incentive Plan).
The Hong Kong Public Offering is open to members of the public in Hong Kong as well
as to institutional and professional investors in Hong Kong. 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” in this section.
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: pool A and pool B (with any
odd lot being allocated to pool A). 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 the brokerage, SFC transaction levy, Stock
Exchange trading fee and AFRC transaction levy 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 the brokerage, SFC
transaction levy, Stock Exchange trading fee and AFRC transaction levy payable) and up to the
total value in pool B.
STRUCTURE OF THE GLOBAL OFFERING
– 541 –


--- page 552 ---
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 753,600 Hong Kong Offer
Shares (being approximately 50% of the 1,507,200 Offer Shares initially available under the
Hong Kong Public Offering) is liable to be rejected.
Reallocation and Clawback
The allocation of the Offer Shares between the Hong Kong Public Offering and the
International Offering is subject to reallocation. Paragraph 4.2 of Practice Note 18 of the
Listing Rules requires a clawback mechanism to be put in place which would have the effect
of increasing 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 if certain
prescribed total demand levels are reached.
In the event that the International Offer Shares are fully subscribed or oversubscribed
under the International Offering, the Joint Representatives shall apply a clawback mechanism
following the closing of the application lists on the following basis, subject to the allocation
basis as stated in Chapter 4.14 under the Listing Guide:
 If the Hong Kong Offer Shares are undersubscribed, the Joint Representatives (for
themselves and on behalf of the Underwriters), at their sole and absolute discretion
(but shall not be under any obligation), may reallocate all or any of the unsubscribed
Hong Kong Offer Shares to the International Offering, in such proportions as the
Joint Representatives deem appropriate;
 If the number of Offer Shares validly applied for under the Hong Kong Public
Offering represents 15 times or more but less than 50 times the number of Offer
Shares initially available for subscription under the Hong Kong Public Offering,
then Offer Shares will be reallocated to the Hong Kong Public Offering from the
International Offering, so that the total number of Offer Shares available under the
Hong Kong Public Offering will increase to up to 4,521,500 Offer Shares,
representing 30% of the Offer Shares initially available under the Global Offering;
 If the number of Offer Shares validly applied for under the Hong Kong Public
Offering represents 50 times or more but less than 100 times the number of Offer
Shares initially available for subscription under the Hong Kong Public Offering,
then Offer Shares will be reallocated to the Hong Kong Public Offering from the
STRUCTURE OF THE GLOBAL OFFERING
– 542 –


--- page 553 ---
International Offering, so that the total number of Offer Shares available under the
Hong Kong Public Offering will increase to up to 6,028,700 Offer Shares,
representing 40% of the Offer Shares initially available under the Global Offering;
and
 If the number of Offer Shares validly applied for under the Hong Kong Public
Offering represents 100 times or more the number of Offer Shares initially available
for subscription under the Hong Kong Public Offering, then Offer Shares will be
reallocated to the Hong Kong Public Offering from the International Offering, so
that the total number of Offer Shares available under the Hong Kong Public Offering
will increase to up to 7,535,800 Offer Shares, representing 50% of the Offer Shares
initially available under the Global Offering.
In addition, the Joint Representatives may in their sole 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 particular, if (i) the International Offering is not fully
subscribed and the Hong Kong Public Offering is fully subscribed or oversubscribed; or (ii) the
International Offering is fully subscribed or oversubscribed and the Hong Kong Public
Offering is fully subscribed or oversubscribed with the number of Offer Shares validly applied
for in the Hong Kong Public Offering representing less than 15 times of the number of Shares
initially available for subscription under the Hong Kong Public Offering, the Joint
Representatives have the authority to reallocate International Offer Shares originally included
in the International Offering to the Hong Kong Public Offering in such number as they deem
appropriate, provided that in accordance with Chapter 4.14 of the Listing Guide, (i) the number
of International Offer Shares reallocated to the Hong Kong Public Offering should not exceed
1,507,200 Shares, representing approximately 10% of the Offer Shares initially available under
the Global Offering, increasing the total number of Offer Shares available under the Hong
Kong Public Offering to 3,014,400 Shares, representing approximately twice the number of the
Offer Shares initially available under the Hong Kong Public Offering; and (ii) the final Offer
Price should be fixed at the bottom end of the indicative Offer Price range (i.e. HK$94.60 per
Offer Share) stated in this prospectus.
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 Joint
Representatives deem appropriate.
In the event that the International Offer Shares are undersubscribed, if the Hong Kong
Offer Shares are also undersubscribed, the Global Offering will not proceed unless the
Underwriters would subscribe or procure subscribers for their respective applicable
proportions of the Offer Shares being offered which are not taken up under the Global Offering
on the terms and conditions of this prospectus and the Underwriting Agreements.
STRUCTURE OF THE GLOBAL OFFERING
– 543 –


--- page 554 ---
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 Joint Representatives (for themselves and on behalf of the Underwriters). If
either the Hong Kong Public Offering or the International Offering is not fully subscribed for,
the Joint Representatives have the authority to reallocate all or any unsubscribed Offer Shares
from such offering to the other, in such proportion as the Joint Representatives deem
appropriate.
Details of any reallocation of Offer Shares between the Hong Kong Public Offering and
the International Offering will be disclosed in the results announcement of the Global Offering,
which is expected to be published on Monday, April 14, 2025.
Applications
Each applicant under the Hong Kong Public Offering will be required to give an
undertaking and confirmation in the application submitted by him that he and any person(s) for
whose benefit he 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 is liable to be rejected if
such undertaking and/or confirmation is/are breached and/or untrue (as the case may be) or if
he has been or will be placed or allocated International Offer Shares under the International
Offering.
Applicants under the Hong Kong Public Offering are required to pay, on application, the
Maximum Offer Price of HK$103.20 per Offer Share in addition to the brokerage, the SFC
transaction levy, the Stock Exchange trading fee and AFRC transaction levy payable on each
Offer Share, amounting to a total of HK$10,424.08 for one board lot of 100 Shares. If the Offer
Price, as finally determined in the manner described in “— Pricing and Allocation” in this
section below, is less than the Maximum Offer Price of HK$103.20 per Offer Share,
appropriate refund payments (including the brokerage, SFC transaction levy, Stock Exchange
trading fee and AFRC transaction levy attributable to the surplus application monies) will be
made to successful applicants, without interest. Further details are set out in the section headed
“How to Apply for Hong Kong Offer Shares” in this prospectus.
STRUCTURE OF THE GLOBAL OFFERING
– 544 –


--- page 555 ---
THE INTERNATIONAL OFFERING
Number of Offer Shares Initially Offered
The International Offering will consist of an offering of initially 13,564,400 Shares,
representing approximately 90% of the total number of Offer Shares initially available under
the Global Offering (subject to reallocation, the Offer Size Adjustment Option and the
Over-allotment Option). The number of Offer Shares initially offered under the International
Offering, subject to any reallocation of Offer Shares between the International Offering and the
Hong Kong Public Offering, will represent approximately 16.31% 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 and no Shares are issued
pursuant to the Pre-IPO Equity Incentive Plan).
Allocation
The International Offering will include selective marketing of Offer Shares to QIBs in the
United States as well as institutional and professional 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” in this
section 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 Shares and/or hold or sell
its Shares after the Listing. Such allocation is intended to result in a distribution of the Shares
on a basis which would lead to the establishment of a solid professional and institutional
shareholder base to the benefit of the Group and the Shareholders as a whole.
The Joint Representatives (on behalf of the Underwriters) may 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 Joint
Representatives 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 Hong Kong Public 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 clawback arrangement described in “— The Hong Kong
Public Offering — Reallocation and Clawback” in this section above, the exercise of the Offer
Size Adjustment Option and the Over-allotment Option in whole or in part and/or any
reallocation of unsubscribed Offer Shares originally included in the Hong Kong Public
Offering.
STRUCTURE OF THE GLOBAL OFFERING
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--- page 556 ---
OFFER SIZE ADJUSTMENT OPTION
In order to provide flexibility for the Joint Representatives to increase the number of
Offer Shares available for purchase under the International Offering to cover additional market
demand, the Company is expected to grant to the Joint Representatives the Offer Size
Adjustment Option, exercisable by the Joint Representatives at their absolute discretion (for
themselves and on behalf of the International Underwriters) on or before the second business
day prior to the Listing Date and will lapse immediately thereafter, to require the Company to
allot and issue up to an aggregate of 2,260,700 additional Shares, representing approximately
15% of the initial number of Offer Shares offered under the Global Offering, at the same price
per Share under the International Offering to cover any excess demand in the International
Offering. The dilution effect of the Offer Size Adjustment Option (assuming the Over-
allotment Option is not exercised) is set out below:
Number of 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 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
15,071,600 18.12% 17,332,300 20.29%
The Offer Size Adjustment Option will not be associated with any price stabilization
activities of the Shares in the secondary market after the listing of our Shares on the Stock
Exchange and will not be subject to the Securities and Futures (Price Stabilizing) Rules of the
SFO (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 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 the allotment results announcement whether and to what
extent the Offer Size Adjustment Option has been exercised, and will confirm in the
announcement that, where the Offer Size Adjustment Option had not been exercised by then,
the Offer Size Adjustment Option has lapsed and cannot be exercised on any future date.
OVER-ALLOTMENT OPTION
In connection with the Global Offering, the Company is expected to grant the
Over-allotment Option to the International Underwriters, exercisable by the Joint
Representatives (on behalf of the International Underwriters).
STRUCTURE OF THE GLOBAL OFFERING
– 546 –


--- page 557 ---
Pursuant to the Over-allotment Option, the International Underwriters will have the right,
exercisable by the Joint Representatives (on behalf of 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, to require the Company to issue up to an aggregate of 2,260,700
additional 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 2,599,800 additional Shares (representing not more than 15% of the Offer
Shares being offered under the Global Offering assuming the Offer Size Adjustment Option is
exercised in full) at the Offer Price, under the International Offering to, among other things,
cover over-allocations in the International Offering, if any.
If the Over-allotment Option is exercised in full, the additional Offer Shares to be issued
pursuant thereto will represent approximately 2.65% of the total Shares in issue (assuming no
exercise of the Offer Size Adjustment Option) or 2.95% of the total Shares in issue (assuming
the Offer Size Adjustment Option is exercised in full) immediately following the completion
of the Global Offering and the issue of Offer Shares pursuant to the Over-allotment Option, and
assuming no Shares are issued under the Pre-IPO Equity Incentive Scheme. If the Over-
allotment Option is exercised, an announcement will be made.
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 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 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 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 any person acting for it) and in what the Stabilization Manager
reasonably regards as the best interest of the Company, (b) may be discontinued at any time
and (c) is required to be brought to an end within 30 days of the last day for lodging
applications under the Hong Kong Public Offering. The number of Shares that may be
over-allocated will not exceed the number of Shares that may be sold under the Over-allotment
Option, being 2,260,700 Shares, which is approximately 15% of the Offer Shares initially
available under the Global Offering.
STRUCTURE OF THE GLOBAL OFFERING
– 547 –


--- page 558 ---
Stabilization action will be entered into in accordance with the laws, rules and regulations
in place in Hong Kong. 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 Shares, (b) selling or
agreeing to sell the 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 Shares, (c) purchasing, or
agreeing to purchase, the 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 Shares for the sole purpose of preventing or minimizing any reduction in
the market price of the Shares, (e) selling or agreeing to sell any 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 any person acting for it) may, in connection with the
stabilizing action, maintain a long position in the Shares;
(b) there is no certainty as to the extent to which and the time or period for which the
Stabilization Manager (or any person acting for it) will maintain such a long
position;
(c) liquidation of any such long position by the Stabilization Manager (or any person
acting for it) and selling in the open market may have an adverse impact on the
market price of the Shares;
(d) no stabilizing action can be taken to support the price of the Shares for longer than
the stabilization period, which will begin on the Listing Date, and is expected to
expire on 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 Shares, and therefore the price of the Shares, could fall;
(e) the price of the Shares cannot be assured to stay at or above the Offer Price either
during or after the stabilization period 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 stabilization actions, the Stabilization Manager will arrange cover of up
to an aggregate of 2,260,700 Shares, representing up to 15% of the initial Offer Shares, through
borrowing of Shares from the Shareholders and/or 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 paid on the Listing Date.
STRUCTURE OF THE GLOBAL OFFERING
– 548 –


--- page 559 ---
The 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 Shares in connection with the Global Offering, the
Stabilization Manager (or any person acting for it) may cover such over-allocations by
exercising the Over-allotment Option in full or in part, by using Shares purchased by the
Stabilization Manager (or any person acting for it) in the secondary market at prices that do not
exceed the Offer Price or through stock borrowing arrangements or a combination of these
means.
PRICING AND ALLOCATION
Pricing for the Offer Shares for the purpose of the various offerings under the Global
Offering will be fixed on the Price Determination Date, which is expected to be on or about
Friday, April 11, 2025 and, in any event, not later than 12:00 noon on Friday, April 11, 2025,
by agreement between the Joint Representatives (on behalf of the Underwriters) and the
Company, and the number of Offer Shares to be allocated under the various offerings will be
determined shortly thereafter.
The Offer Price will not be more than HK$103.20 per Offer Share and is expected to be
not less than HK$94.60 per Offer Share, unless otherwise announced, as further explained
below. Applicants under the Hong Kong Public Offering must pay, on application, the
Maximum Offer Price of HK$103.20 per Offer Share plus brokerage of 1%, SFC transaction
levy of 0.0027%, Stock Exchange trading fee of 0.00565% and AFRC transaction levy of
0.00015%, amounting to a total of HK$10,424.08 for one board lot of 100 Shares. Prospective
investors should be aware that the Offer Price to be determined on the Price
Determination Date may be, but is not expected to be, lower than the minimum Offer
Price stated in this prospectus.
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 Joint Representatives (on behalf of the Underwriters) may, where they deem
appropriate, based on the level of interest expressed by prospective investors during the
book-building process in respect of the International Offering, and with the consent of the
Company, reduce the number of Offer Shares offered and/or the Offer Price Range 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 a case, the Company will, as soon
STRUCTURE OF THE GLOBAL OFFERING
– 549 –


--- page 560 ---
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 websites of the Company and the Stock Exchange at
www.dualitybiologics.com and www.hkexnews.hk , respectively, notices of the reduction and
the cancellation of the Global Offering and relaunch of the offer at the revised number of Offer
Shares and/or the revised indicative Offer Price range.
The Company will also, as soon as practicable following the decision to make such
change, issue a supplemental or new prospectus updating investors of the change in the number
of Offer Shares and/or the indicative Offer Price range, and giving investors at least three
business days to consider the new information. The supplemental or new prospectus should
include at least the following: updated (i) Offer Price range and market capitalization; (ii)
listing timetable and underwriting obligations; (iii) price/earnings multiple, unaudited pro
forma and adjusted net tangible assets; and (iv) use of proceeds and confirmation of the
working capital adequacy based on the revised estimated proceeds.
Before submitting applications for the Hong Kong Offer Shares, applicants should have
regard to the possibility that any announcement of a reduction in the number of Offer Shares
and/or the Offer Price range may not be made until the last day for lodging applications under
the Hong Kong Public Offering. Such notice will also include confirmation or revision, as
appropriate, of the working capital statement and the Global Offering statistics as currently set
out in this prospectus, and any other financial information which may change as a result of any
such reduction. In the absence of any such notice so published, the number of Offer Shares will
not be reduced and/or the Offer Price, if agreed upon by the Joint Representatives (on behalf
of the Underwriters) and the Company, will under no circumstances be set outside the Offer
Price Range as stated in this prospectus.
If there is any change to the offer size due to change in the number of Offer Shares offered
in the Global Offering (other than pursuant to the reallocation mechanism as disclosed in this
prospectus), or change to the Offer Price falling outside the indicative Offer Price range as
stated in this prospectus, or if the 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, after the issue of this prospectus
and before the commencement of dealings in our Shares as prescribed under Rule 11.13 of the
Listing Rules, we are required to cancel the Global Offering and relaunch the offer with a
supplemental prospectus or a new prospectus in FINI.
The final Offer Price, the level of indications of interest in the International Offering, the
level of applications in the Hong Kong Public Offering, the basis of allocations of the Hong
Kong Offer Shares and the results of allocations in the Hong Kong Public Offering are
expected to be made available through a variety of channels in the manner described in the
section headed “How to Apply for Hong Kong Offer Shares — B. Publication of Results” in
this prospectus.
STRUCTURE OF THE GLOBAL OFFERING
– 550 –


--- page 561 ---
STOCK BORROWING AGREEMENT
In order to facilitate the settlement of over-allocations, if any, in connection with the
Global Offering, the Stabilization Manager, its affiliates, or any person acting for it may choose
to borrow up to an aggregate of 2,260,700 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 2,599,800 Shares (representing not more
than 15% of the Offer Shares being offered under the Global Offering assuming the Offer Size
Adjustment Option is exercised in full) from DualityBio Ltd. pursuant to a Stock Borrowing
Agreement, or acquire Shares from other sources, including the exercising of the Over-
allotment Option. The Stock Borrowing Agreement is expected to be entered into between the
Stabilization Manager and DualityBio Ltd. on or about the Price Determination Date.
The same number of Shares as that borrowed must be returned to DualityBio Ltd. or its
respective nominees on or before the fifth business day following the earlier of (i) the last day
on which the Over-allotment Option may be exercised, and (ii) the day on which the
Over-allotment Option is exercised in full, or such earlier time as may be agreed in writing
between the parties.
The stock borrowing arrangement under the Stock Borrowing Agreement will be effected
in compliance with all applicable laws, Listing Rules and regulatory requirements.
No payment will be made to DualityBio Ltd. by the Stabilization Manager or its
authorized agents in relation to such stock borrowing arrangement.
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 and is subject to,
among other things, the Joint Representatives (on behalf of the Underwriters) and the Company
agreeing on the Offer Price.
The Company expects to enter into the International Underwriting Agreement relating to
the International Offering on the Price Determination Date.
These underwriting arrangements, including the Underwriting Agreements, are
summarized in the section headed “Underwriting” in this prospectus.
CONDITIONS OF THE GLOBAL OFFERING
Acceptance of all applications for Offer Shares will be conditional on, among other
things:
(a) the Listing Committee granting approval for the listing of, and permission to deal in,
the Shares in issue and to be issued pursuant to the Global Offering on the Main
Board of the Stock Exchange and such approval not subsequently having been
withdrawn or revoked prior to the commencement of trading of the Shares on the
Stock Exchange;
STRUCTURE OF THE GLOBAL OFFERING
– 551 –


--- page 562 ---
(b) the Offer Price having been agreed between the Joint Representatives (for
themselves and on behalf of the Underwriters) and the Company;
(c) the execution and delivery of the International Underwriting Agreement on or about
the Price Determination Date; and
(d) 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 or otherwise,
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).
If, for any reason, the Offer Price is not agreed between the Joint Representatives (for
themselves and on behalf of the Underwriters) and the Company by 12:00 noon on Friday,
April 11, 2025, the Global Offering will not proceed and will lapse.
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.
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 websites of the Company
and the Stock Exchange at www.dualitybiologics.com and www.hkexnews.hk , respectively,
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 the section headed “How to Apply for Hong
Kong Offer Shares — D. Despatch of Share Certificates and Refund of Application Monies”
in this prospectus. In the meantime, all application monies will be held in separate bank
account(s) with the receiving banks or other bank(s) in Hong Kong licensed under the Banking
Ordinance (Chapter 155 of the Laws of Hong Kong).
Share certificates for the Offer Shares will only become valid at 8:00 a.m. on Tuesday,
April 15, 2025, provided that the Global Offering has become unconditional in all respects at
or before that time.
DEALINGS IN THE SHARES
Assuming that the Hong Kong Public Offering becomes unconditional at or before 8:00
a.m. in Hong Kong on Tuesday, April 15, 2025, it is expected that dealings in the Shares on
the Stock Exchange will commence at 9:00 a.m. on Tuesday, April 15, 2025.
The Shares will be traded in board lots of 100 Shares each and the stock code of the
Shares will be 9606.
STRUCTURE OF THE GLOBAL OFFERING
– 552 –


--- page 563 ---
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 the “HKEXnews > New Listings > New Listing
Information” section, and our website at www.dualitybiologics.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. APPLICATIONS 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 for:
 are 18 years of age or older; and
 have a Hong Kong address ( for the White Form eIPO service only ).
 are outside the United States, and are not a United States Person (as defined in
Regulation S under the U.S. Securities Act); and
 are not a legal or natural person of the PRC (except those who have complied with
all relevant PRC laws and regulations in relation to such application, including but
not limited to qualified domestic institutional investors).
Unless permitted by the Listing Rules or any relevant waivers and/or consents have been
granted by the Stock Exchange to us, you cannot apply for any Hong Kong Offer Shares if you
or the person(s) for whose benefit you are applying for:
 are an existing Shareholder or close associates; or
 are a Director or any of his/her close associates.
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 553 –


--- page 564 ---
2. Application Channels
The Hong Kong Public Offering period will begin at 9:00 a.m. on Monday, April 7,
2025 and end at 12:00 noon on Thursday, April 10, 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
www.eipo.com.hk
Applicants who would
like to receive a
physical Share
certificate. Hong
Kong Offer Shares
successfully applied
for will be allotted
and issued in your
own name.
From 9:00 a.m. on
Monday, April 7,
2025 to 11:30 a.m.
on Thursday,
April 10, 2025,
Hong Kong time.
The latest time for
completing full
payment of
application monies
will be 12:00 noon
on Thursday,
April 10, 2025,
Hong Kong time.
HKSCC
EIPO
channel /H1118/H1118/H1118
Y our broker or custodian
who is a HKSCC
Participant will submit
an EIPO application on
your behalf through
HKSCC’s FINI system
in accordance with
your instruction.
Applicants who would
not like to receive a
physical 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 of the application period to apply for Hong Kong Offer Shares.
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 554 –


--- page 565 ---
For those applying through the White Form eIPO service, once you complete payment
in respect of any application instructions 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 electronic
application instructions are given, you shall be deemed to have declared that only one set of
electronic 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
electronic 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 the 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 HKSCC EIPO channel, an actual application will be deemed
to have been made for any application instructions 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.
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 555 –


--- page 566 ---
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
 Identity document’s issuing country
or jurisdiction
 Identity document type, with order
of priority:
i. HKID card; or
ii. National identification document;
or
iii. Passport; and
 Identity document number
 Full name(s)
2 as shown on your
identity document
 Identity document’s issuing country
or jurisdiction
 Identity document type, with order
of priority:
i. LEI registration document; or
ii. Certificate of incorporation; or
iii. Business registration certificate;
or
iv. Other equivalent document; and
 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
card.
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 an English and Chinese name, both English
and Chinese names must be used. Otherwise, either English or Chinese names 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 to subscribe for
shares in the Hong Kong Public Offering. 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.
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 556 –


--- page 567 ---
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 joint beneficial owner. If you do not include this information, the application will be
treated as being made for your benefit.
6. If you are applying as 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.
“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 HKSCC EIPO channel, and making an application under a
power of attorney, we and the Joint Representatives, as our agent, have discretion to consider
whether to accept it on any conditions we 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/H1118100 Shares
Permitted number of
Hong Kong Offer
Shares for
application and
amount payable on
application/successful
allotment /H1118/H1118/H1118/H1118/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 maximum Offer Price is HK$103.20 per Offer
Share. 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.
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 557 –


--- page 568 ---
By instructing your broker or custodian to apply for the
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
final Offer Price, brokerage, SFC transaction levy, the
Stock Exchange trading fee and the AFRC transaction
levy by debiting the relevant nominee bank account at
the Designated Bank for your broker or custodian.
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 maximum amount payable
on application in full upon application for Hong Kong
Offer Shares.
Duality Biotherapeutics, Inc. (Stock Code 9606)
(HK$103.20 per Hong Kong Offer Share)
NUMBER OF HONG KONG OFFER SHARES THAT MAY BE APPLIED
FOR AND PAYMENTS
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2)
on application
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2)
on application
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2)
on application
No. of
Hong Kong
Offer Shares
applied for
Amount
payable (2)
on application
HK$ HK$ HK$ HK$
100 10,424.08 2,000 208,481.54 10,000 1,042,407.72 200,000 20,848,154.40
200 20,848.16 2,500 260,601.94 20,000 2,084,815.45 250,000 26,060,193.00
300 31,272.24 3,000 312,722.31 30,000 3,127,223.15 300,000 31,272,231.60
400 41,696.30 3,500 364,842.70 40,000 4,169,630.88 350,000 36,484,270.20
500 52,120.39 4,000 416,963.09 50,000 5,212,038.60 400,000 41,696,308.80
600 62,544.46 4,500 469,083.48 60,000 6,254,446.32 450,000 46,908,347.40
700 72,968.54 5,000 521,203.85 70,000 7,296,854.05 500,000 52,120,386.00
800 83,392.61 6,000 625,444.63 80,000 8,339,261.75 600,000 62,544,463.20
900 93,816.70 7,000 729,685.40 90,000 9,381,669.48 700,000 72,968,540.40
1,000 104,240.77 8,000 833,926.18 100,000 10,424,077.20 753,600
(1) 78,555,845.78
1,500 156,361.16 9,000 938,166.95 150,000 15,636,115.80
(1) Maximum number of Hong Kong Offer Shares you may apply for and this is 50% of the Hong Kong Offer
Shares initially offered.
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 569 ---
(2) The amount payable is inclusive of brokerage, SFC transaction levy, the Stock Exchange trading fee and
Accounting and Financial Reporting Council (“ AFRC ”) transaction levy. If your application is successful,
brokerage will be paid to the Exchange Participants (as defined in the Listing Rules) or to the Hong Kong
Share Registrar (for applications made through the application channel of the Hong Kong Share Registrar)
while the SFC transaction levy, the Stock Exchange trading fee and the AFRC transaction levy will be paid
to the SFC, the Stock Exchange and the AFRC, respectively.
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 the paragraph headed “ — A. Applications for Hong Kong
Offer Shares — 3. Information Required to Apply ” in this section. If you are suspected of
submitting or cause to submit more than one application, all of your applications will be
rejected.
Multiple applications made either through (i) the White Form eIPO service, (ii) 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 HKSCC EIPO channel,
you or the person(s) for whose benefit you have made the application shall not apply for any
Offer Shares.
6. Terms and Conditions of An Application
By applying for Hong Kong Offer Shares through the White Form eIPO service or
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 authorise us and/or the
Joint Representatives, 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 understand 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;
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 570 ---
(iv) confirm that you are aware of the restrictions on offers and sales of shares set out
in this prospectus and they do not apply to you, or the person(s) for whose benefit
you have made the application;
(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 the Relevant Persons
1, the Hong Kong Share Registrar and HKSCC will
not be liable for any information and representations not in this prospectus and any
supplement to it;
(vii) 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 Hong Kong 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 under the paragraph headed “ — G. Personal Data
— 3. Purposes ” and “— 4. Transfer of personal data ” in this section;
(viii) 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;
(ix) 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 Hong Kong Share
Registrar by way of publication of the results at the time and in the manner as
specified in the paragraph headed “— B. Publication of Results ” in this section;
(x) confirm that you are aware of the situations specified in the paragraph headed “ —
C. Circumstances In Which You Will Not Be Allocated Hong Kong Offer Shares ”i n
this section;
(xi) 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;
1 As defined in this prospectus, Relevant Persons would include the Company, the Joint Sponsors, the Joint
Representatives, the Overall Coordinators, the Joint Global Coordinators, the Joint Bookrunners, the Joint
Lead Managers, the Underwriters, the Capital Market Intermediaries, and any of their respective directors,
officers, employees, partners, agents, advisers, representatives and any other parties involved in the Global
Offering.
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 571 ---
(xii) agree to comply with the Companies Ordinance, the Companies (Winding Up and
Miscellaneous Provisions) Ordinance, the 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;
(xiii) 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 Shares registered in your name or otherwise held by you;
(xiv) warrant that the information you have provided is true and accurate;
(xv) confirm that you understand that we and the Joint Representatives 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;
(xvi) agree to accept Hong Kong Offer Shares applied for or any lesser number allocated
to you under the application;
(xvii) 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;
(xviii) (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 electronic application
instructions to HKSCC directly or indirectly or through the application channel of
the Hong Kong Share Registrar or by any one as your agent or by any other person;
and
(xix) (if you are making the application as an agent for the benefit of another person)
warrant that (1) 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 electronic application instructions to HKSCC and (2) you
have due authority to give electronic application instructions on behalf of that other
person as its agent.
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 572 ---
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/H1118/H1118/H1118The designated results of
allocations 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
Monday, April 14, 2025 to
12:00 midnight on Sunday,
April 20, 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 ).
The Stock Exchange’s website at
www.hkexnews.hk and our
website at
www.dualitybiologics.com
which will provide links to the
above mentioned websites of
the Hong Kong Share
Registrar.
No later than 11:00 p.m. on
Monday, April 14, 2025 (Hong
Kong time).
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 573 ---
Platform Date/Time
Telephone /H1118/H1118/H1118+852 2862 8555 — the allocation
results telephone enquiry line
provided by the Hong Kong
Share Registrar.
between 9:00 a.m. and 6:00 p.m.,
from Tuesday, April 15, 2025
to Tuesday, April 22, 2025
(Hong Kong time) (except
Saturday, Sunday and public
holiday in Hong Kong).
For those applying through HKSCC EIPO channel, you may also check with your broker
or custodian from 6:00 p.m. on Friday, April 11, 2025 (Hong Kong time).
HKSCC Participants can log into FINI and review the allotment result from 6:00 p.m. on
Friday, April 11, 2025 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 results of the final Offer Price, 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 Hong Kong Offer Shares on the Stock Exchange’s
website at www.hkexnews.hk and our website at www.dualitybiologics.com by no later than
11:00 p.m. on Monday, April 14, 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 for:
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.
2. If we or our agents exercise our discretion to reject your application:
We, the Joint Representatives, the Hong Kong 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.
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 574 ---
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 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
the paragraph headed “ — A. Applications for Hong Kong Offer Shares — 5. Multiple
Applications Prohibited ” in this section 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;
 we or the Joint Representatives believe that by accepting your application, it or we
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.
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 Hong Kong 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.
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 575 ---
D. DESPATCH OF SHARE CERTIFICATES AND REFUND OF APPLICATION
MONIES
Y ou will receive one 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 Share certificates will be deposited into CCASS as described
below).
No temporary document of title will be issued in respect of the Shares. No receipt will
be issued for sums paid on application.
Share certificates will only become valid at 8:00 a.m. on Tuesday, April 15, 2025 (Hong
Kong time), provided that the Global Offering has become unconditional and the right of
termination described in the section headed “Underwriting” has not been exercised. Investors
who trade Shares prior to the receipt of Share certificates or the Share certificates becoming
valid do so entirely at their own risk.
The right is reserved to retain any Share certificate(s) and (if applicable) any surplus
application monies pending clearance of application monies.
The following sets out the relevant procedures and time:
White Form eIPO service HKSCC EIPO channel
Despatch/collection of Share certificate 2
For physical share
certificates of
equal or over
500,000 Offer
Shares issued
under your own
name
Collection in person from the
Hong Kong 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
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
2 Except in the event of a tropical cyclone warning signal number 8 or above, a black rainstorm warning and/or
an “extreme conditions” announcement issued after a super typhoon in force in Hong Kong in the morning on
Monday, April 14, 2025 rendering it impossible for the relevant share certificates to be dispatched to HKSCC
in a timely manner, the Company shall procure the Hong Kong Share Registrar to arrange for delivery of the
supporting documents and share certificates in accordance with the contingency arrangements as agreed
between them. Y ou may refer to “— E. Severe Weather Arrangements” in this section.
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 576 ---
White Form eIPO service HKSCC EIPO channel
Time : from 9:00 a.m. to 1:00
p.m. on Tuesday, April 15,
2025 (Hong Kong time) If you
are an individual, you must not
authorise any other person to
collect for you.
If you are a corporate applicant,
your authorised representative
must bear a letter of
authorization from your
corporation stamped with your
corporation’s chop
Both individuals and authorised
representatives must produce,
at the time of collection,
evidence of identity acceptable
to the Hong Kong Share
Registrar
Note : If you do not collect your
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
For physical share
certificates of
less than
500,000 Offer
Shares issued
under your own
name
Y our Share certificate(s) will be
sent to the address specified in
your application instructions
by ordinary post at your own
risk
Time : Monday, April 14, 2025
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 577 ---
White Form eIPO service HKSCC EIPO channel
Refund mechanism for surplus application monies paid by you
Date Tuesday, April 15, 2025 Subject to the arrangement
between you and your broker
or custodian
Responsible party Hong Kong Share Registrar Y our broker or custodian
Application
monies paid
through single
bank account
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
Refund cheque(s) will be
despatched to the address as
specified in your application
instructions by ordinary post at
your own risk
E. SEVERE WEATHER ARRANGEMENTS
The Opening and Closing of the Application Lists
The application lists will not open or close on Thursday, April 10, 2025 if, there is/are:
 a tropical cyclone warning signal number 8 or above;
 a black rainstorm warning; and/or
 an “extreme conditions” announcement issued after a super typhoon (“ Extreme
Conditions ”), (collectively, “ Severe Weather Signals ”),
in force in Hong Kong at any time between 9:00 a.m. and 12:00 noon on Thursday, April 10,
2025.
Instead they will open between 11:45 a.m. and 12:00 noon and/or close at 12:00 noon on
the next business day which does not have Severe Weather Signals in force at any time between
9:00 a.m. and 12:00 noon.
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 578 ---
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 the section headed “Expected Timetable” in this prospectus, an
announcement will be made and published on the Stock Exchange’s website at
www.hkexnews.hk and our website at www.dualitybiologics.com of the revised timetable.
If a Severe Weather Signal is hoisted on Monday, April 14, 2025, the Hong Kong Share
Registrar will make appropriate arrangements for the delivery of the share certificates to the
CCASS Depository’s service counter so that they would be available for trading Tuesday, April
15, 2025.
If a Severe Weather Signal is hoisted on Tuesday, April 15, 2025: for physical share
certificates of 500,000 or more Offer Shares issued under your own name, you may collect the
physical share certificates from the Hong Kong Share Registrar’s office after the Severe
Weather Signal is lowered or cancelled (e.g. in the afternoon of Tuesday, April 15, 2025 or on
Wednesday, April 16, 2025).
If a Severe Weather Signal is hoisted on Monday, April 14, 2025: for physical share
certificates of less than 500,000 of Offer Shares issued under your own name, despatch will be
made by ordinary post when the post office re-opens after the Severe Weather Signal is lowered
or cancelled (e.g. in the afternoon of Monday, April 14, 2025 or on Tuesday, April 15, 2025).
Prospective investors should be aware that if they choose to receive physical share
certificates issued in their own name, there may be a delay in receiving the share
certificates.
F. ADMISSION OF THE SHARES INTO CCASS
If the Stock Exchange grants the listing of, and permission to deal in, the Shares on the
Stock Exchange and we comply with the stock admission requirements of HKSCC, the 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 Shares 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 HKSCC
Operational Procedures in effect from time to time.
All necessary arrangements have been made enabling the Shares to be admitted into
CCASS.
Y ou should seek the advice of your broker or other professional advisor for details of the
settlement arrangement as such arrangements may affect your rights and interests.
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 579 ---
G. PERSONAL DATA
The following Personal Information Collection Statement applies to any personal data
collected and held by the Company, the Hong Kong 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. This 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 the applicant for, and holder of,
Hong Kong Offer Shares, of the policies and practices of the Company and the Hong Kong
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 your 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 Hong Kong 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 Hong Kong
Share Registrar.
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 Hong Kong 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 despatch of 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 Hong Kong 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 cheque and 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;
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 580 ---
 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
Shares including, where applicable, HKSCC Nominees;
 maintaining or updating the register of members of the Company;
 verifying identities of applicants for and holders of the Shares and identifying any
duplicate applications for the Shares;
 facilitating Hong Kong Offer Shares balloting;
 establishing benefit entitlements of holders of the Shares, such as dividends, rights
issues, bonus issues, etc.;
 distributing communications from the Company and its subsidiaries;
 compiling statistical information and profiles of the holders of the 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 Hong Kong Share Registrar to discharge their obligations to
applicants and holders of the Shares and/or regulators and/or any other purposes to
which applicants and holders of the Shares may from time to time agree.
4. Transfer of personal data
Personal data held by the Company and the Hong Kong Share Registrar relating to the
applicants for and holders of Hong Kong Offer Shares will be kept confidential but the
Company and the Hong Kong 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 advisers, 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 Hong Kong 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);
HOW TO APPLY FOR HONG KONG OFFER SHARES
– 570 –


--- page 581 ---
 any agents, contractors or third-party service providers who offer administrative,
telecommunications, computer, payment or other services to the Company or the
Hong Kong Share Registrar in connection with their respective business operation;
 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
purpose 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 Hong Kong Share Registrar will keep the personal data of the
applicants and holders of Hong Kong Offer Shares for as long as necessary to fulfil 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).
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 Hong Kong 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 Hong Kong 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 and the Hong Kong Share Registrar, at their
registered address disclosed in the section headed “Corporate information” in this
prospectus or as notified from time to time, for the attention of the company
secretary, or the Hong Kong Share Registrar for the attention of the privacy
compliance officer.
HOW TO APPLY FOR HONG KONG OFFER SHARES
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--- page 582 ---
The following is the text of a report set out on pages I-1 to I-3, received from the
Company’ s reporting accountant, PricewaterhouseCoopers, Certified Public Accountants,
Hong Kong, for the purpose of incorporation in this prospectus. It is prepared and addressed
to the directors of the Company and to the Joint Sponsors pursuant to the requirements of
HKSIR 200, Accountants’ Reports on Historical Financial Information in Investment Circulars
issued by the Hong Kong Institute of Certified Public Accountants.
ACCOUNTANT’S REPORT ON HISTORICAL FINANCIAL INFORMATION TO THE
DIRECTORS OF DUALITY BIOTHERAPEUTICS, INC. AND MORGAN STANLEY
ASIA LIMITED, JEFFERIES HONG KONG LIMITED AND CITIC SECURITIES
(HONG KONG) LIMITED
Introduction
We report on the historical financial information of Duality Biotherapeutics, Inc. (the
“Company”) and its subsidiaries (together, the “Group”) set out on pages I-4 to I-51, which
comprises the consolidated balance sheets as at 31 December 2023 and 2024, the balance
sheets of the Company as at 31 December 2023 and 2024, and the consolidated statements of
comprehensive loss, the consolidated statements of changes in equity and the consolidated
statements of cash flows for each of the years ended 31 December 2023 and 2024 (the “Track
Record Period”) 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-51 forms an integral part of this report, which has been prepared for inclusion
in the prospectus of the Company dated 7 April 2025 (the “Prospectus”) in connection with the
initial listing of shares of the Company on the Main Board of The Stock Exchange of Hong
Kong Limited.
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 Historical Financial Information
that is free from material misstatement, whether due to fraud or error.
APPENDIX I ACCOUNTANT’S REPORT
– I-1 –


--- page 583 ---
Reporting accountant’s 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 (“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.
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 accountant’s judgment, 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 accountant considers internal control relevant to the entity’s
preparation of 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
accountant’s report, a true and fair view of the financial position of the Company as at 31
December 2023 and 2024 and the consolidated financial position of the Group as at 31
December 2023 and 2024 and of its consolidated financial performance and its consolidated
cash flows for the Track Record Period in accordance with the basis of preparation set out in
Note 2.1 to the Historical Financial Information.
APPENDIX I ACCOUNTANT’S REPORT
– I-2 –


--- page 584 ---
Report on matters under the Rules Governing the Listing of Securities on The Stock
Exchange of Hong Kong Limited (the “Listing Rules”) 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 28 to the Historical Financial Information which states that no dividends
have been paid by the Company in respect of the Track Record Period.
No statutory financial statements for the Company
No statutory financial statements have been prepared for the Company since its date of
incorporation.
PricewaterhouseCoopers
Certified Public Accountants
Hong Kong
7 April, 2025
APPENDIX I ACCOUNTANT’S REPORT
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--- page 585 ---
I HISTORICAL FINANCIAL INFORMATION OF THE GROUP
Preparation of Historical Financial Information
Set out below is the Historical Financial Information which forms an integral part of this
accountant’s report.
The financial statements of the Group for the Track Record Period, on which the
Historical Financial Information is based, were audited by PricewaterhouseCoopers in
accordance with International Standards on Auditing (“ISAs”) issued by the International
Auditing and Assurance Standards Board (“Underlying Financial Statements”).
The Historical Financial Information is presented in Renminbi (“RMB”) and all amounts
are rounded to the nearest thousand (RMB’000) except when otherwise stated.
APPENDIX I ACCOUNTANT’S REPORT
– I-4 –


--- page 586 ---
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
Notes
Y ear ended 31 December
2023 2024
RMB’000 RMB’000
Revenue /H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 1,786,540 1,941,257
Cost of revenue /H1118/H1118/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 (427,655) (1,156,590)
Gross Profit /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,358,885 784,667
Research and development expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186 (558,997) (836,726)
Administrative expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186 (62,567) (158,692)
Other 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/H11188 3,261 7,338
Other gains, net /H1118/H1118/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 40,773 14,421
Operating profit/(loss) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118781,355 (188,992)
Finance 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/H111810 34,483 48,112
Finance costs /H1118/H1118/H1118/H1118/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 (188) (250)
Fair value change of financial liabilities at fair
value through profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111825 (1,017,899) (873,416)
Loss before income tax /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(202,249) (1,014,546)
Income tax expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111811 (155,263) (35,888)
Loss for the year attributable to the owners of
the Company /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(357,512) (1,050,434)
Other comprehensive loss:
Items that will not be reclassified to profit or loss
Exchange differences on translation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(19,553) (37,950)
Changes in fair value of financial liabilities from
own credit risk /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,688) (15)
Other comprehensive loss for the year,
net of tax /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(21,241) (37,965)
Total comprehensive loss for the year
attributable to the owners of the Company /H1118/H1118 (378,753) (1,088,399)
Loss per share for the loss attributable to
owners of the Company
Basic and diluted loss per share (in RMB) /H1118/H1118/H1118/H1118/H1118/H111812 (44.7) (131.3)
APPENDIX I ACCOUNTANT’S REPORT
– I-5 –


--- page 587 ---
CONSOLIDATED BALANCE SHEETS
Notes
As at 31 December
2023 2024
RMB’000 RMB’000
ASSETS
Non-current assets
Property, plant and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814 12,313 13,072
Intangible assets /H1118/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 54,248 46,237
Right-of-use assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815 5,445 5,523
Other non-current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111822 94,008 115,555
Total non-current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118166,014 180,387
Current assets
Cash and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111817 1,130,889 1,208,906
Restricted cash /H1118/H1118/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 42,645 45,155
Term deposits with initial term over three months /H1118 19 – 181,766
Trade receivables /H1118/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 100,803 379,021
Prepayments and other receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821 27,024 24,598
Other current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111822 32,534 70,389
Total current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,333,895 1,909,835
Total assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,499,909 2,090,222
DEFICITS
Share capital /H1118/H1118/H1118/H1118/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 66
Other reserves /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111824 31,861 223,343
Accumulated losses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,155,780) (2,245,248)
Deficits attributable to the owners of
the Company /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,123,913) (2,021,899)
Total deficits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,123,913) (2,021,899)
LIABILITIES
Non-current liabilities
Contract liabilities /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 60,164 238,251
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,412 2,302
Total non-current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111862,576 240,553
Current liabilities
Financial liabilities at fair value through
profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111825 2,132,720 3,046,784
Trade payables /H1118/H1118/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 234,814 670,910
Other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111827 34,674 60,631
Contract liabilities /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 156,132 90,256
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
2,906 2,987
Total current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,561,246 3,871,568
Net current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,227,351 1,961,733
Total liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,623,822 4,112,121
Total deficits and liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,499,909 2,090,222
APPENDIX I ACCOUNTANT’S REPORT
– I-6 –


--- page 588 ---
THE COMPANY BALANCE SHEETS
Notes
As at 31 December
2023 2024
RMB’000 RMB’000
ASSETS
Non-current assets
Investments in subsidiaries /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111833 994,762 1,199,848
Total non-current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118994,762 1,199,848
Current assets
Cash and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111817 6,201 1,885
Prepayments and other receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,937 4,205
Total current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11189,138 6,090
Total assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,003,900 1,205,938
DEFICITS
Share capital /H1118/H1118/H1118/H1118/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 66
Other reserves /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111824 29,155 195,505
Accumulated losses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,158,101) (2,062,751)
Deficits attributable to the owners of
the Company /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,128,940) (1,867,240)
Total deficits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,128,940) (1,867,240)
LIABILITIES
Current liabilities
Financial liabilities at fair value through
profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111825 2,132,720 3,046,784
Other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111827 120 26,394
Total current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,132,840 3,073,178
Net current liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,123,702 3,067,088
Total liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,132,840 3,073,178
Total deficits and liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,003,900 1,205,938
APPENDIX I ACCOUNTANT’S REPORT
– I-7 –


--- page 589 ---
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
Attributable to the owners of the Company
Share capital
Other
reserves
Accumulated
losses Total deficits
RMB’000 RMB’000 RMB’000 RMB’000
Balances at 1 January 2023 /H1118/H1118/H1118/H1118/H11186 (16,085) (753,038) (769,117)
Comprehensive loss
Loss for the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – (357,512) (357,512)
Surplus reserves /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 45,230 (45,230) –
Other comprehensive loss
Items that will not be reclassified
to profit or loss
Exchange differences on
translation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (19,553) – (19,553)
Changes in fair value of financial
liabilities from own credit risk /H1118/H1118 – (1,688) – (1,688)
Transactions with owners in
their capacity as owner:
Share-based compensation
expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 23,957 – 23,957
Balance at 31 December 2023 /H1118/H1118/H1118 6 31,861 (1,155,780) (1,123,913)
Comprehensive loss
Loss for the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – (1,050,434) (1,050,434)
Surplus reserves /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 39,034 (39,034) –
Other comprehensive loss
Items that will not be reclassified
to profit or loss
Exchange differences on
translation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (37,950) – (37,950)
Changes in fair value of financial
liabilities from own credit risk /H1118/H1118 – (15) – (15)
Transactions with owners in
their capacity as owner:
Share-based compensation
expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 190,413 – 190,413
Balance at 31 December 2024 /H1118/H1118/H1118 6 223,343 (2,245,248) (2,021,899)
APPENDIX I ACCOUNTANT’S REPORT
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CONSOLIDATED STATEMENTS OF CASH FLOWS
Notes
For the year ended 31 December
2023 2024
RMB’000 RMB’000
Cash flows from operating activities
Cash generated from operating activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111829 1,030,781 292,209
Income tax paid /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(248,929) (54,540)
Interest received /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111834,483 48,112
Net cash inflow from operating activities /H1118/H1118/H1118/H1118/H1118/H1118816,335 285,781
Cash flows from investing activities
Purchase of property, plant and equipment /H1118/H1118/H1118/H1118/H1118/H1118(11,284) (4,079)
Purchase of intangible assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(24,621) (27,100)
Payments for financial assets at fair value through
profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (1,362,145)
Redemption of financial assets at fair value
through profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 1,362,145
Interest received on financial assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 2,248
Increase in term deposits with initial term
over three months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (179,710)
Changes in restricted cash balances /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(42,645) (2,510)
Net cash outflow from investing activities /H1118/H1118/H1118/H1118/H1118 (78,550) (211,151)
Cash flows from financing activities
Proceeds from issuance of convertible
preferred shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111825 151,101 –
Repayments of loans with warrants to purchase
Series B-2 Preferred Shares from convertible
preferred shareholders /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111825 (135,191) –
Settlement of financial assets at fair value through
profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,162) –
Deposits in relation to lease agreements /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(244) (653)
Principal element of lease payments /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(3,499) (3,397)
Interests elements of lease payments /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(188) (250)
Payment of listing expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (3,321)
Net cash inflow from/(outflow to) financing
activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111810,817 (7,621)
Net increase in cash and cash equivalents /H1118/H1118/H1118/H1118/H1118 748,602 67,009
Cash and cash equivalents at the beginning
of 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/H1118/H1118/H1118375,974 1,130,889
Effect of foreign exchange rate changes on cash
and cash equivalents /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,313 11,008
Cash and cash equivalents at end of year /H1118/H1118/H1118/H1118/H11181,130,889 1,208,906
APPENDIX I ACCOUNTANT’S REPORT
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--- page 591 ---
II NOTES TO THE HISTORICAL FINANCIAL INFORMATION
1 GENERAL INFORMATION
Duality Biotherapeutics, Inc. (the “Company”) was incorporated on 3 July 2019 in the Cayman Islands with
limited liabilities under the Companies Law Cap. 22 of the Cayman Islands. The address of the Company’s registered
office is at Harneys Fiduciary (Cayman) Limited, 4th Floor, Harbour Place, 103 South Church Street, George Town,
P .O. Box 10240, Grand Cayman KY1-1002, Cayman Islands.
The Company is an investment holding company. The Company and its subsidiaries (hereinafter collectively
referred to as the “Group”) are a global clinical-stage biopharmaceutical company discovering, developing next
generation Antibody-Drug Conjugate therapeutics in the People’s Republic of China (the “PRC”) and United States
of America (the “US”).
2 BASIS OF PREPARATION AND NEW OR AMENDED STANDARDS OR INTERPRETATIONS
2.1 Basis of preparation
The Historical Financial Information have been prepared in accordance with all applicable International
Financial Reporting Standards issued by the International Accounting Standards Board (“IFRS Accounting
Standards”). The Historical Financial Information have been prepared under the historical cost convention, except for
financial assets and financial liabilities measured at fair value through profit or loss.
The preparation of the Historical Financial Information in conformity with IFRS Accounting Standards
requires the use of certain critical accounting estimates. It also requires management to exercise its judgment in
the process of applying the Group’s accounting policies. The areas involving a higher degree of judgment or
complexity, or areas where assumptions and estimates are significant to the Historical Financial Information are
disclosed in Note 4.
The accounting policies applied in the preparation of the Historical Financial Information have been
consistently applied to the Track Record Period, unless otherwise stated.
Other than those material accounting policies information as disclosed in the notes to the relevant financial line
items or transactions in this Historical Financial Information, a summary of the other accounting policies information
has been set out in Note 35 to this Historical Financial Information.
The Group had net current liabilities of RMB1,961.7 million as at 31 December 2024, of which the convertible
preferred shares classified as current liabilities were RMB3,046.8 million and contract liabilities were RMB90.3
million, which do not result in future cash payments. The Group had net liabilities of RMB2,021.9 million as at 31
December 2024, of which the convertible preferred shares classified as liabilities were RMB3,046.8 million and
contract liabilities were RMB328.5 million, which do not result in future cash payments. The directors of the
Company assessed the Group’s liquidity by evaluating its ability to generate cash from operating activities, attract
additional capital or other means of finance funding. Historically, the Group has relied principally on both operational
sources of cash (e.g. revenue from out-licensing) and non-operational sources of financing from investors (e.g.
convertible preferred shares) to fund its research and development activities.
Pursuant to the resolution passed by the shareholders of the Company in September 2022, the Company shall
redeem, at the option of any holder of outstanding convertible preferred shares, all of the outstanding convertible
preferred shares held by the requesting holder, at any time after the earliest occurrence of failure to complete the
qualified public offering within four years after 23 April 2021, which was the date of Initial USD Closing as defined
in Series B share purchase agreements and a few other specified events. Please refer to Note 25 for details. In August
2024, the Company entered into supplemental agreements with respect to certain rights with the shareholders to
suspend such redemption feature for a period commencing on the day immediately prior to the date of the Company’s
first submission of the listing application, until the earlier of:
(a) the withdrawal of the listing application by the Company;
(b) the rejection of the listing application by the Hong Kong Stock Exchange; and
(c) the expiration of eighteen months after the first submission date.
APPENDIX I ACCOUNTANT’S REPORT
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--- page 592 ---
Based on the above factors and the Group’s historical performance and management’s operating and financing
plans, the directors of the Company believe the cash and cash equivalents and the operating and financing cash flows
are sufficient to meet the cash requirements to fund the Group’s planned operations, capital expenditures and other
obligations for at least the next twelve months after 31 December 2024. Therefore, the Historical Financial
Information have been prepared on a going concern basis, which contemplates the realization of assets and settlement
of liabilities in the normal course of business.
2.2 New or amended standards, amendments or interpretations
All effective standards, amendments to standards and interpretations, which are mandatorily effective for the
financial year beginning on 1 January 2024, are consistently applied to the Group for the Track Record Period.
New standards, amendments and interpretations not yet adopted
Standards, amendments and interpretations that have been issued but not yet effective and not been early
adopted by the Group during the Track Record Period are as follows:
Standards Key requirements
Effective for annual periods
beginning on or after
Amendments to IAS 21 /H1118/H1118/H1118/H1118Lack of exchangeability 1 January 2025
Amendments to IFRS 9
and IFRS 7 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Amendments to the classification and
measurement of financial instruments
1 January 2026
Amendments to IFRS 9 and
IFRS 7 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Contracts referencing nature-dependent
electricity
1 January 2026
Annual improvements
project /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Annual improvements to IFRS Accounting
Standards — volumes 11
1 January 2026
IFRS 18 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Presentation and disclosure in financial
statements
1 January 2027
IFRS 19 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Subsidiaries without public accountability:
disclosures
1 January 2027
Amendments to IFRS 10
and IAS 28 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Sale or contribution of assets between an
investor and its associate or joint venture
To be determined
The Group has already commenced an assessment of the impact of these new or revised standards, amendments
and interpretations, certain of which are relevant to the Group’s operations. According to the preliminary assessment
made by the directors, these standards and amendments are not expected to have a significant impact on the Group’s
financial performance and position, except IFRS 18, which may mainly impact the presentation of the consolidated
statements of the comprehensive loss and the Group is still in the process of assessing the impact.
3 FINANCIAL RISK MANAGEMENT
3.1 Financial risk factors
The Group’s activities expose it to a variety of financial risks: market risk (including foreign exchange risk,
cash flow and fair value interest rate risk), credit risk and liquidity risk. The Group’s overall risk management
programme focuses on the unpredictability of financial markets and seeks to minimize potential adverse effects on
the Group’s financial performance. Risk management is carried out by the management of the Group.
3.1.1 Market risk
(i) Foreign exchange risk
Foreign exchange risk arises when future commercial transactions or recognized assets and liabilities
are denominated in a currency that is not the Group entities’ functional currency. The Company’s functional
currency is USD. The Company’s primary subsidiaries were incorporated in the PRC and these subsidiaries
considered RMB as their functional currency.
APPENDIX I ACCOUNTANT’S REPORT
– I-11 –


--- page 593 ---
The Group operates mainly in the PRC. There are certain cash and bank balances, trade receivables,
other non-current assets and other payables denominated in a currency that is not the functional currency. The
Group constantly reviews the economic situation and its foreign exchange risk profile, and will consider
appropriate hedging measures, as may be necessary.
At 31 December 2023 and 2024, if the USD strengthened/weakened by 5% against the RMB with all
other variables held constant, net loss for the years would have been RMB25,878,000 lower/higher and
RMB47,348,000 lower/higher, respectively.
At 31 December 2023 and 2024, if the Euro strengthened/weakened by 5% against the RMB with all
other variables held constant, net loss for the years would have been RMB84,000 lower/higher and
RMB74,000 lower/higher, respectively.
(ii) Cash flow and fair value interest rate risk
Interest rate risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate
because of changes in market interest rates. The Group’s exposure to the risk of changes in market interest rates
relates primarily to the Group’s interest-bearing cash and cash equivalents and term deposits with initial term
over three months. When cash and cash equivalents and term deposits with initial term over three months
obtained at variable rates expose the Group to cash flow interest-rate risk. The Group has not hedged its cash
flow or fair value interest-rate risk. The cash and cash equivalents and term deposits with initial term over three
months are disclosed in Note 17 and 19.
The Group has no significant interest-bearing assets except for cash and cash equivalents and term
deposits with initial term over three months, details of which have been disclosed in Note 17 and 19.
3.1.2 Credit risk
Credit risk arises from cash and cash equivalents, term deposits, restricted cash, trade receivables as well as
other receivables. The carrying amount of each class of the above financial assets represents the Group’s maximum
exposure to credit risk in relation to the corresponding class of financial assets.
To manage this risk, cash and cash equivalents, term deposits and restricted cash are mainly deposited with
state-owned or reputable financial institutions in the PRC and reputable international financial institutions outside of
the PRC. There has been no recent history of default in relation to these financial institutions.
For trade receivables, management applies the IFRS 9 simplified approach to measuring expected credit losses
which uses a lifetime expected loss allowance for all trade receivables. The directors of the Group believe that there
is no material credit risk inherent in the Group’s outstanding balance of trade receivables, details of which have been
disclosed in Note 20.
For other receivables and other non-current assets, management has assessed that during the years ended 31
December 2023 and 2024, 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, 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.
APPENDIX I ACCOUNTANT’S REPORT
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--- page 594 ---
3.1.3 Liquidity risk
The Group aims to maintain sufficient cash and cash equivalents or have available facility through an adequate
amount of available financing to meet its daily operating working capital.
The table below analyzes the Group’s non-derivative financial liabilities that will be settled into relevant
maturity grouping based on the remaining period at each balance sheet date to the contractual maturity date. The
amounts disclosed in the table are the contractual undiscounted cash flows.
The following table presents the Group’s contractual maturities of financial liabilities at 31 December 2024:
Less than
1 year
Between 1 and
2 years
Between 2 and
5 years Over 5 years Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Trade payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118670,91 0––– 670,910
Other payables (excluding
salaries and welfare
payables and V A T and
other taxes payables) /H1118/H1118/H111820,41 7––– 20,417
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H11183,169 940 1,568 – 5,677
694,496 940 1,568 – 697,004
The following table presents the Group’s contractual maturities of financial liabilities at 31 December 2023:
Less than
1 year
Between 1 and
2 years
Between 2 and
5 years Over 5 years Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Trade payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118234,81 4––– 234,814
Other payables (excluding
salaries and welfare
payables and V A T and
other taxes payables) /H1118/H1118/H111810,16 8––– 10,168
Lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H11183,119 2,082 408 – 5,609
248,101 2,082 408 – 250,591
The Group recognizes the convertible preferred shares liabilities and loans with warrants to purchase Series
B-2 Preferred Shares at fair value through profit or loss. Accordingly, these liabilities are managed on a fair value
basis rather than by maturing dates (Note 25).
3.2 Capital management
The Group’s objectives when managing capital are to safeguard the Group’s ability to continue as a going
concern in order to provide returns for shareholders and benefits for other stakeholders and to maintain an optimal
capital structure to reduce the cost of capital.
In order to maintain or adjust the capital structure, the Group may adjust the amount of dividends paid to
shareholders, issue new shares or sell assets to reduce debt.
The Group monitors capital (including share capital and convertible preferred shares on an as-if-converted
basis) by regularly reviewing the capital structure. As a part of this review, the Company considers the cost of capital
and the risks associated with the issued share capital. In the opinion of the directors of the Company, the Group’s
capital risk is low.
As at 31 December 2023 and 2024, the Group was in a net cash position, hence it is not meaningful to present
the gearing ratio.
APPENDIX I ACCOUNTANT’S REPORT
– I-13 –


--- page 595 ---
3.3 Fair value estimation
Fair value hierarchy
This section explains the judgments and estimates made in determining the fair values of the financial
instruments that are recognized and measured at fair value in the financial statements. To provide an indication about
the reliability of the inputs used in determining fair value, the Group has classified its financial instruments into the
three levels prescribed under the accounting standards.
Level 1: The fair value of financial instruments traded in active markets (such as publicly traded
derivatives, and equity securities) is based on quoted market prices at the end of the reporting
period. The quoted market price used for financial assets held by the Group is the current bid
price.
Level 2: The fair value of financial instruments that are not traded in an active market is determined using
valuation techniques which maximize the use of observable market data and rely as little as
possible on entity-specific estimates. If all significant inputs required to fair value an instrument
are observable, the instrument is included in level 2.
Level 3: If one or more of the significant inputs is not based on observable market data, the instrument
is included in level 3.
The following table presents the Group’s assets and liabilities that were measured at fair value at 31 December
2024:
Level 1 Level 2 Level 3 Total
RMB’000 RMB’000 RMB’000 RMB’000
Liabilities
Financial liabilities at fair value
through profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 3,046,784 3,046,784
– – 3,046,784 3,046,784
The following table presents the Group’s liabilities that were measured at fair value at 31 December 2023:
Level 1 Level 2 Level 3 Total
RMB’000 RMB’000 RMB’000 RMB’000
Liabilities
Financial liabilities at fair value
through profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 2,132,720 2,132,720
– – 2,132,720 2,132,720
(i) V aluation techniques used to determine fair values
Specific valuation techniques used to value financial instruments mainly include binomial option-
pricing model or discounted cash flow analysis.
There were no changes in valuation techniques for the years ended 31 December 2023 and 2024.
(ii) V aluation processes
The Group’s finance team manages the valuation of level 3 instruments for financial reporting purposes.
The team manages the valuation exercise of the relevant instruments on a case by case basis. At least once a
year, the team uses valuation techniques to determine the fair value of the Group’s level 3 instruments.
External valuers will be involved when necessary.
APPENDIX I ACCOUNTANT’S REPORT
– I-14 –


--- page 596 ---
The summary of significant unobservable inputs to the valuation of financial instruments together with
a quantitative sensitivity analysis was disclosed in Note 25.
4 CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS
The preparation of the Historical Financial Information requires the use of accounting estimates which, by
definition, will seldom equal the actual results. Management also needs to exercise judgment in applying the Group’s
accounting policies.
Estimates and judgments are continually evaluated. They are based on historical experience and other factors,
including expectations of future events that may have a financial impact on the entity and that are believed to be
reasonable under the circumstances.
(i) Fair value of convertible preferred shares
The fair value of convertible preferred shares that are not traded in an active market is determined by using
valuation techniques. The Group applied the back-solve method and discounted cash flow approach to determine the
underlying equity value of the Company and adopted option-pricing method and equity allocation model to determine
the fair value of the convertible preferred shares. Key assumptions such as discount rate, volatility and discount for
lack of marketability (“DLOM”) are disclosed in Note 25.
(ii) Share-based compensation
The Group has granted share options to the Group’s employees. The Company has engaged an independent
valuer to determine the fair value of the options granted to employees, which is expensed over the vesting periods.
Unobservable inputs such as the risk-free interests rate, volatility and dividend yield, etc. are used in determining the
fair value of the share-based compensations.
(iii) Impairment of non-current assets
The Group assesses impairment based on its subjective judgment and determines the separate cash flows of a
specific group of assets, useful lives of assets and the future possible income and expenses arising from the assets
depending on how assets are utilized and industrial characteristics. Any changes of economic circumstances or
estimates due to the change of Group strategy might cause material impairment on assets in the future.
Intangible assets not ready for use are not subject to amortization and are tested annually for impairment, or
more frequently if events or changes in circumstances indicate that they might be impaired. The Group obtained
in-licenses and In-Process Research and Development (“IPR&D”) to continue research and development work and
commercialize the products, which are classified as intangible assets not ready for use.
An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable
amount. The recoverable amount is the higher of an asset’s fair value less costs of disposal and value in use. For the
purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable
cash flows (cash-generating units (“CGU”)).
(iv) Accrual of research and development expenses
Research and development expenses include costs paid to hospitals and third-party contract research
organizations (CROs). The estimate of accrual of research and development expenses is complex because billing
terms under relevant contracts often do not coincide with the timing of when the work is performed, which in turn
requires estimates of outstanding obligations as of period end. These estimates are based on a number of factors,
including management’s knowledge of the research and development (“R&D”) programs and activities associated
with timelines, invoicing date, and the provisions in the contracts.
APPENDIX I ACCOUNTANT’S REPORT
– I-15 –


--- page 597 ---
(v) Revenue recognition
(i) Identification of performance obligations and allocation of the transaction price
The Group identifies the performance obligations within the contracts and evaluates which performance
obligations are distinct, which requires the use of judgment. The Group has determined that both the licenses of
intellectual property and research and development services are each capable of being distinct. The Group also
determined that the promises to transfer the licenses of intellectual property and to provide research and development
services are distinct within the context of the contract. Then the Group allocates the transaction price between the
licenses of intellectual property and research and development services based on their relative standalone selling
prices. The Group uses residual approach to estimate the stand-alone selling price of the licenses of intellectual
property as well as expected cost plus a margin approach to estimate the stand-alone selling price of research and
development services.
(ii) Estimation of variable consideration
The consideration within the contracts includes variable consideration such as milestone payments and
sales-based royalties,. The Group determines the amount of milestone payments by using either the expected value
or the most likely amount based on which method better predicts the amount of consideration to which it will be
entitled. The Group assesses whether the milestones are considered highly probable of being achieved and estimates
the amount to be included in the transaction price using the most likely amount method. In making these assessments,
the Group considers various factors such as the scientific, clinical, regulatory, commercial, and other risks that must
be overcome to achieve a particular milestone. For sales-based royalties, the Group recognizes the revenue when the
occurrence of the subsequent sales.
5 SEGMENT AND REVENUE INFORMATION
Management has determined the operating segments based on the reports reviewed by the chief operating
decision-maker (“CODM”). The CODM, who is responsible for allocating resources and assessing performance of
the operating segment, has been identified as the executive directors of the Group.
(a) Description of segments and principal activities
The Group is principally engaged in the research and development of new drugs. The CODM reviews the
operating results of the business as one operating segment to make decisions about resources to be allocated.
Therefore, the CODM regards that there is only one segment which is used to make strategic decisions.
(b) License and collaboration agreements with customers
The Group entered into a number of license and collaboration agreements with certain customers during the
Track Record Period. Under the terms of these agreements, the Group agreed to grant licenses of certain intellectual
properties and to provide research and development services in relation to certain licensed products to the relevant
customers. The considerations of these agreements generally consist of non-refundable upfront payment,
reimbursements for research and development costs incurred, and variable considerations including milestone
payments and royalties on net sales of the licensed products.
(c) Disaggregated revenue information is as follows:
For the year ended 31 December
2023 2024
RMB’000 RMB’000
Type of revenue
Revenue from the license and collaboration agreement /H1118/H1118/H1118/H1118/H11181,781,088 1,937,049
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,452 4,208
1,786,540 1,941,257
APPENDIX I ACCOUNTANT’S REPORT
– I-16 –


--- page 598 ---
For the year ended 31 December
2023 2024
RMB’000 RMB’000
Timing of revenue recognition
Over time /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118356,924 1,257,298
At a point in time /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,429,616 683,959
1,786,540 1,941,257
(d) Liabilities related to contracts with customers
The Group has recognized the following liabilities related to contracts with customers:
As at 31 December
2023 2024
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118216,296 328,507
During the Track Record Period, revenue recognized in relation to contract liabilities that was included in the
contract liabilities at the beginning of the year is as follows:
As at 31 December
2023 2024
RMB’000 RMB’000
Revenue recognized that was included in the contract
liabilities at beginning of the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 154,258
The unsatisfied performance obligations arising from the contracts with customers, is as follows:
As at 31 December
2023 2024
RMB’000 RMB’000
Within one 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/H1118156,132 90,256
Above one 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/H111860,164 238,251
216,296 328,507
(e) Accounting policy of revenue recognition
Revenue from contracts with customers is recognized when control of goods or services is transferred to the
customers at an amount that reflects the consideration to which the Group expects to be entitled in exchange for those
goods or services.
At contract inception, the Group assesses the goods or services promised within each contract and determines
those that are performance obligations and assesses whether each promised good or service is distinct.
The Group considers the terms of the contracts to determine the transaction price. 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.
APPENDIX I ACCOUNTANT’S REPORT
– I-17 –


--- page 599 ---
The Group recognizes revenue only when it satisfies a performance obligation by transferring control of the
promised goods or services. The transfer of control can occur over time or at a point in time. A performance
obligation is satisfied over time if it meets one of the following criteria.
– The counterparty simultaneously receives and consumes the benefits provided by the Group’s
performance as the Group performs.
– The Group’s performance creates or enhances an asset that the counterparty controls as the asset is
created or enhanced.
– The Group’s performance does not create an asset with an alternative use to the Group and the Group
has an enforceable right to payment for performance completed to date.
If control of the goods and services transfers over time, revenue is recognized over the period of the contract
by reference to the progress towards complete satisfaction of that performance obligation. The Group adopts an
appropriate method of measuring progress for the purpose of recognizing revenue. The Group evaluates the measure
of progress at the end of each reporting period and, if necessary, adjusts the measure of performance and related
revenue recognition.
The Group enters into license and collaboration agreements for research, development, manufacturing and
commercialization services. The terms of these arrangements typically include non-refundable upfront payments,
reimbursements for costs incurred, milestone payments and royalties on net sales of licensed products. The contracts
generally do not include a significant financing component.
Licenses of intellectual property: The Group assesses whether the licensing of the Group’s intellectual property
is distinct from the other performance obligations identified in the arrangements. For licenses determined to be
distinct, the Group recognizes revenue from non-refundable, upfront payments allocated to the license at a point in
time, when the license is transferred to the licensee and the licensee is able to use and benefit from the license.
Research and development services: For research and development services determined to be distinct, the
portion of the reimbursements for costs incurred and other transaction price allocated to the performance obligations
is recognized as revenue over time as delivery or performance of such services occurs.
The Group uses judgment to determine whether milestones or other variable consideration should be included
in the transaction price.
Milestone payments: At the inception of each arrangement that includes milestone payments, the Group
assesses whether the milestones are considered highly probable of being achieved and estimates the amount to be
included in the transaction price using the most likely amount method.
In making these assessments, the Group considers various factors such as the scientific, clinical, regulatory,
commercial, and other risks that must be overcome to achieve a particular milestone. Milestone payments that are
subject to regulatory approvals and commercialization stages are not considered highly probable of being achieved
until those approvals are received or commercialization stages are achieved.
The transaction price will be allocated to each performance obligation on a relative stand-alone selling price
basis, for which the Group recognizes revenue as or when the performance obligations are satisfied. At the end of
each subsequent reporting period, the Group re-evaluates the probability of achievement of all milestones subject to
constraint and, if necessary, adjusts its estimate of the overall transaction price.
Royalties: For arrangements that include sales-based royalties, the Group recognizes revenue at the later of (i)
when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been
allocated has been satisfied (or partially satisfied).
The excess of cumulative revenue recognized in profit or loss over the cumulative billings to customers is
recognized as contract assets. The excess of cumulative billings to customers over the cumulative revenue recognized
in profit or loss is recognized as contract liabilities.
APPENDIX I ACCOUNTANT’S REPORT
– I-18 –


--- page 600 ---
6 EXPENSES BY NATURE
Y ear ended 31 December
2023 2024
RMB’000 RMB’000
Technical services expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118883,272 1,677,860
Employee benefit expenses (Note 7) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118117,234 355,510
Professional services expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111828,247 28,618
Warehouse, logistics and insurance service expenses /H1118/H1118/H1118/H1118/H1118/H1118/H11188,208 24,377
Listing expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 24,145
Impairment of intangible assets (Note 16) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 21,350
Depreciation and amortization /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,987 7,870
Traveling expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,759 5,518
Auditors’ remuneration /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118300 –
Other expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,212 6,760
1,049,219 2,152,008
7 EMPLOYEE BENEFIT EXPENSES
Y ear ended 31 December
2023 2024
RMB’000 RMB’000
Share-based compensation expenses (Note 13) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,957 190,413
Wages, salaries and bonus /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111884,729 147,053
Social insurance (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/H11188,268 17,535
Other welfare for employees /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118280 509
117,234 355,510
(a) Social insurance
The employees of the Group’s subsidiaries participate in various government-sponsored defined contribution
pension plans and various government supervised housing funds, medical insurance and other employee social
insurance plan under which these subsidiaries are required to make monthly contributions to these plans at certain
percentages of the employee’s monthly salaries and wages subject to certain ceilings. During the years ended 31
December 2023 and 2024, the Group had no forfeited contributions under these plans which may be utilized by the
Group to reduce its contributions for the current year.
The Group has no other material obligation for the payment of retirement benefit associated with these
schemes beyond the annual contribution described above.
(b) Five highest paid individuals
The five individuals whose emoluments were the highest in the Group include 1 director for the years ended
31 December 2023 and 2024, whose emoluments are reflected in the analysis shown in Note 32. The emoluments
payable to the remaining individuals during the year are as follows:
Y ear ended December 31
2023 2024
RMB’000 RMB’000
Share-based compensation expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,628 42,124
Wages, salaries and bonus /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815,432 14,796
Social insurance /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118891 827
Other welfare for employees /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118404 387
22,355 58,134
APPENDIX I ACCOUNTANT’S REPORT
– I-19 –


--- page 601 ---
The emoluments fell within the following bands:
Y ear ended December 31
2023 2024
Emolument bands
HKD3,500,001 to HKD4,000,000 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181–
HKD4,000,001 to HKD4,500,000 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181–
HKD5,000,001 to HKD5,500,000 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181–
HKD8,000,001 to HKD8,500,000 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–1
HKD9,000,001 to HKD9,500,000 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–1
HKD11,000,001 to HKD11,500,000 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181–
HKD16,500,001 to HKD17,000,000 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–1
HKD29,500,001 to HKD30,000,000 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–1
44
8 OTHER INCOME
Grants from the government are recognized at their fair value where there is a reasonable assurance that the
subsidies will be received and the Group will comply with all attached conditions.
Y ear ended 31 December
2023 2024
RMB’000 RMB’000
Government grants /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,154 7,124
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118107 214
3,261 7,338
9 OTHER GAINS, NET
Y ear ended 31 December
2023 2024
RMB’000 RMB’000
Foreign exchange gains, net /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111841,935 12,273
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(1,162) 2,148
40,773 14,421
10 FINANCE INCOME
Y ear ended 31 December
2023 2024
RMB’000 RMB’000
Finance income:
Finance income from bank deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111834,483 48,112
Finance costs:
Interest expense on lease liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(188) (250)
Finance income – net /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111834,295 47,862
APPENDIX I ACCOUNTANT’S REPORT
– I-20 –


--- page 602 ---
11 INCOME TAX EXPENSE
Current income tax
The current income tax charge is calculated on the basis of the tax laws enacted or substantively enacted at
the end of the reporting period in the countries where the Company and its subsidiaries operate and generate taxable
income. Management periodically evaluates positions taken in tax returns with respect to situations in which
applicable tax regulation is subject to interpretation and considers whether it is probable that a taxation authority will
accept an uncertain tax treatment. The Group measures its tax balances either based on the most likely amount or the
expected value, depending on which method provides a better prediction of the resolution of the uncertainty.
The Group’s principal applicable taxes and tax rates are as follows:
(a) Cayman Islands
Under the current laws of the Cayman Islands, the Company is not subject to tax on income or capital gains.
Additionally, the Cayman Islands does not impose a withholding tax on payments of dividends to shareholders.
(b) Hong Kong
Under the current Hong Kong Inland Revenue Ordinance, the Group’s subsidiary in Hong Kong is subject to
Hong Kong profit tax on its taxable income generated from operations in Hong Kong at two-tiered profits tax rates,
8.25% for first HKD2 million of assessable profits and 16.5% for assessable profits above HKD2 million.
Additionally, payments of dividends by the subsidiary incorporated in Hong Kong to the Company are not subject
to any Hong Kong withholding tax. No provision for Hong Kong profits tax has been provided for at the rate of 16.5%
as the Group’s subsidiary in Hong Kong has no estimated assessable profit during the Track Record Period.
(c) United States
DualityBio Inc. is incorporated in the United States and is subject to federal income tax at 21% and state and
local income tax (generally ranges from 1% to 12%) where it has operation. DualityBio Inc. did not have any taxable
income, therefore no income tax expense was accrued for the Track Record Period.
(d) Mainland China
Duality Biologics (Suzhou) Co., Ltd. incorporated in the PRC is subject to Corporate Income Tax at a rate of
15% as the “High and New Technology Enterprises” certificate was obtained on 19 November 2024 with a valid
period of three years. Duality Biologics (Shanghai) Co., Ltd. incorporated in the PRC is subject to Corporate Income
Tax at a rate of 25%. Beijing Duality Biologics Co., Ltd. incorporated in the PRC, as a small and micro enterprise,
can enjoy a 20% Corporate Income Tax rate on 25% of the taxable income amount for the proportion of taxable
income not exceeding RMB3 million.
According to the Corporate Income Tax Law of the PRC and the respective regulations, the income derived
by a resident enterprise in China from the transfer of technology which meets certain prescribed criteria could be
eligible for income tax incentives. The part of the annual income from the transfer of technology derived by a resident
enterprise within RMB5 million shall be tax-exempt; and the remainder shall be subject to a 50% reduction in the
enterprise income tax rate. During the year ended 31 December 2023 and 2024, Duality Biologics (Suzhou) Co., Ltd
has incurred income of transfer of technology for the above mentioned tax reduction and exemption incentives.
No provision for Mainland China profits tax has been provided for at a rate of 15%, 20% or 25% pursuant to
the Corporate Income Tax Law of the PRC and the respective regulations (the “CIT Law”), as the Group has no
estimated assessable profits during the Track Record Period.
(e) Withholding tax
According to the CIT rules and regulations, distribution of profits earned by PRC companies is generally
subject to a withholding tax of 10% upon the distribution of profits to overseas-incorporated immediate holding
companies. Depending on the tax residency of the foreign shareholder, the withholding tax rate may be adjusted based
on the relevant bilateral tax treaty. During the years ended 31 December 2023 and 2024, the Group does not have
any profit distribution plan.
APPENDIX I ACCOUNTANT’S REPORT
– I-21 –


--- page 603 ---
Withholding tax on revenue from out-licensing
The Group entered into a number of license and collaboration agreements with certain overseas customers.
According to the local income tax rules and regulations in the tax jurisdictions of the customers, a withholding tax
might be triggered for the whole or part of the income arising from the license and collaboration agreements.
The tax on the Group’s loss before income tax differs from the theoretical amount that would arise using the
statutory tax rate applicable to loss of the consolidated entities as follows:
Y ear ended 31 December
2023 2024
RMB’000 RMB’000
Loss before income tax /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(202,249) (1,014,546)
Income tax expenses calculated at applicable tax rates /H1118/H1118/H1118/H1118/H1118215,130 13,446
Withholding tax /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118155,263 35,888
Additional deduction of research and development expense /H1118/H1118 (83,331) (91,908)
Expenses not deductible for tax purposes /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814,031 97
Tax exempted interest income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(906) –
Taxable income reduction or exemption arising from
technology transfer income /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(171,560) (90,998)
Deductible temporary differences for which no deferred tax
asset was recognized /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814,630 72,561
Utilisation of previously unrecognized tax losses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(32,395) –
Tax losses for which no deferred income tax asset was
recognized, net /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111844,401 96,802
Income tax expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118155,263 35,888
No deferred tax asset has been recognized in respect of the tax losses and deductible temporary difference due
to the unpredictability of future profit streams.
12 LOSS PER SHARE
(a) Basic loss per share
Basic loss per share is calculated by dividing the loss of the Group attributable to the equity holders of the
Company by weighted average number of ordinary shares outstanding during the Track Record Period.
For the year ended 31 December
2023 2024
Loss attributable to the ordinary equity holders of
the Company (RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(357,512) (1,050,434)
Weighted average number of ordinary shares in issue
(in thousands) /H1118/H1118/H1118/H1118/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 8,000
Basic loss per share (RMB) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(44.7) (131.3)
(b) Diluted loss per share
Diluted loss per share is calculated by adjusting the weighted average number of ordinary shares outstanding
to assume conversion of all dilutive potential ordinary shares.
For the years ended 31 December 2023 and 2024, the Company had two categories of potential ordinary shares,
namely the stock options granted to employees and convertible preferred shares of the Company. As the Group
incurred losses for the years ended 31 December 2023 and 2024, the potential ordinary shares were not included in
the calculation of diluted loss per share as their inclusion would be anti-dilutive.
Accordingly, diluted loss per share for the years ended 31 December 2023 and 2024 are the same as basic loss
per share.
APPENDIX I ACCOUNTANT’S REPORT
– I-22 –


--- page 604 ---
13 SHARE-BASED COMPENSATION
Accounting policy for share-based compensation
The Group operates stock options granted to employees, under which the Group receives services from
employees as consideration for equity instruments of the Group. The fair value of the employee services received in
exchange for the grant of equity instruments (options) is recognized as an expense during the Track Record Period.
The total amount to be expensed is determined by reference to the fair value of the equity instruments granted:
 including any market performance conditions;
 excluding the impact of any service and non-market performance vesting conditions (for example, the
requirement for employees to serve);
 including the impact of any non-vesting conditions.
At the end of each reporting period, the Group revises its estimates of the number of options that are expected
to vest based on the non-market vesting performance and service conditions. It recognizes the impact of the revision
to original estimates, if any, in the consolidated statements of comprehensive loss, with a corresponding adjustment
to equity.
(i) Employee share option
The Group adopted a number of employee share option plans to provide long-term incentives for its employees
and directors of the Group to deliver long-term shareholder returns. Under the plans, participants are granted options
which only vest if certain conditions are met. Participation in the plan is at the board of directors’ discretion.
Except for the share options granted to certain key management personnel, for substantially all the
abovementioned share options granted, in the event of termination of service prior to the initial public offering of the
Company (“IPO”), the grantees may only retain certain percentage of the abovementioned “temporarily owned” share
options. The remaining portion of these share options shall be forfeited immediately. The retention ratio shall be
determined as follows:
Y ears of service upon termination of service Retention ratio
Less than 3 years /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–
3 – 4 years /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111840%
4 – 5 years /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111850%
More than 5 years /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/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%
Substantially all the share options granted shall not be exercisable until the IPO. The expiry dates of the share
options granted are the tenth anniversary of the grant dates.
Basically, the share options are divided into two categories as follows, according to whether the vesting is
dependent upon achievement of specified performance targets.
(a) Share options without performance targets (“Service-based Options”)
For the year ended 31 December 2023, the Company granted 5,221,959 Service-based Options at nil
consideration to certain employees of the Group, of which 2,731,959 were granted to the founder of the Group.
For the year ended 31 December 2024, the Company granted 1,918,500 Service-based Options at nil
consideration to certain employees of the Group, of which no options were granted to the founder of the Group.
Pursuant to relevant award agreements, the abovementioned options were generally divided in several
tranches and to be “temporarily owned” by the grantees with the following schedules:
(a) 25% of the share options on the first anniversary of the grant date and the remaining 75% monthly
thereafter in 36 equal monthly instalments; or
(b) 33% of the share options immediately on the grant date and the remaining 67% over a period of
around two years on a case-by-case basis.
APPENDIX I ACCOUNTANT’S REPORT
– I-23 –


--- page 605 ---
The following table summarizes the movements in the number of Service-based Options granted and
their related weighted average exercise price during the years ended 31 December 2023 and 2024.
Y ear ended 31 December 2023 Y ear ended 31 December 2024
Average exercise
price per
Service-based
Option
Number of
Service-based
Options
Average exercise
price per
Service-based
Options
Number of
Service-based
Options
USD USD
At beginning of the year /H1118/H1118/H1118/H1118 0.53 11,149,044 0.65 16,241,003
Granted /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180.89 5,221,959 0.90 1,918,500
Forfeited /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180.72 (130,000) 0.82 (390,000)
At end of the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180.65 16,241,003 0.67 17,769,503
(b) Share options with performance targets (“Milestone Options”)
For the year ended 31 December 2023, the Company granted nil Milestone Options to certain employees
of the Group.
For the year ended 31 December 2024, the Company granted 903,920 Milestone Options at nil
consideration to certain employees of the Group, of which 903,920 options were granted to the founder of the
Group.
Pursuant to relevant award agreements, the vesting schedule is as follows, on the condition that the
grantee meet specified performance targets (“Milestone”).
Vesting date Percentage of an option
Date of milestone achievement /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111833%
First anniversary of milestone achievement /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111833%
Second anniversary of milestone achievement /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111834%
As of 31 December 2024, management expected that the completion of milestones was probable and one
of the milestones was already completed.
The following table summarizes the movements in the number of Milestone Options granted and their
related weighted average exercise price during the years ended 31 December 2023 and 2024.
Y ear ended 31 December 2023 Y ear ended 31 December 2024
Average exercise
price per
Milestone Option
Number of
Milestone
Options
Average exercise
price per
Milestone Option
Number of
Milestone
Options
USD USD
At beginning of the year /H1118/H1118/H1118/H1118 ––––
Granted /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 1.60 903,920
Forfeited /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118––––
At end of the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 1.60 903,920
APPENDIX I ACCOUNTANT’S REPORT
– I-24 –


--- page 606 ---
(ii) Fair value of share options granted
At the grant date, the assessed fair value of above options granted during the years ended 31 December 2023
and 2024 was as follows:
Number of options
Weighted average fair value per option
IPO as non-market
performance
condition*
IPO as non-vesting
condition*
USD USD
Share options granted in the year ended
31 December 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,221,959 5.04 2.27
Share options granted in the year ended
31 December 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,822,420 5.65 3.96
* For the portion of share options that cannot be retained in the event of termination of service prior to
the IPO, IPO is regarded as non-market performance condition. For the remaining portion that can be
retained even in the event of termination of service prior to the IPO, IPO is regarded as non-vesting
condition.
As a private company with no quoted market price of the Company’s equity instruments, the Company needs
to estimate the fair value of the Group’s equity interests at the relevant grant date.
The directors of the Company estimated the risk-free interest rate based on the yield of US Treasury Bond with
a maturity life close to the option life of the share option. Expected volatility was estimated at grant date based on
average of historical volatilities of the comparable companies with length commensurable to the time to maturity of
the share option.
The fair value of the share options granted have been valued by an independent qualified valuer using the
binomial valuation model as at the relevant grant date. Key assumptions are set as below:
Risk-free
interest rate Expected volatility Dividend yield
Share options granted in the year ended
31 December 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183.8%-4.5% 57.3-58% 0.0%
Share options granted in the year ended
31 December 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184%-4.8% 56.5-58% 0.0%
(iii) Expenses arising from share-based payment transactions
Expenses for the share-based compensation have been charged to the consolidated statements of
comprehensive loss as follows:
Y ear ended 31 December
2023 2024
RMB’000 RMB’000
Research and development expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815,662 129,334
Administrative expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,295 61,079
23,957 190,413
APPENDIX I ACCOUNTANT’S REPORT
– I-25 –


--- page 607 ---
Before 2024, management expected IPO was not probable as no IPO plan was in anticipation. Hence, for the
portion of share options that cannot be retained in the event of termination of service prior to the IPO, management
considered that the IPO was a performance condition and thus no share-based compensation expense was recorded
for the years ended 31 December 2023.
For certain portion of share options that can be retained in the event of termination of service prior to the IPO
and are exercisable only if an IPO occurs, IPO was a non-vesting condition for the years ended 31 December 2023
and it was considered in the grant-date fair value.
As of 31 December 2024, management updated their expectation and considered IPO became probable to occur
and the Group re-assessed whether IPO is non-vesting condition or non-market performance condition as well as
re-estimated the number of share options that are expected to vest, probability of meeting this non-market
performance condition.
Accordingly, the Group determined the cumulative share-based compensation expenses as at 31 December
2024 and all changes in the cumulative expenses between the beginning and end of the period were recognized in
profit or loss during the year ended 31 December 2024.
14 PROPERTY, PLANT AND EQUIPMENT
Accounting policy for property, plant and equipment
(i) Recognition and subsequent measurement
Property, plant and equipment, comprising office equipment, electronic equipment, laboratory equipment and
leasehold improvement are stated at historical cost less depreciation and impairment losses, if any. Historical cost
includes expenditure that is directly attributable to the acquisition of the items.
Subsequent costs are included in the asset’s carrying amount or recognized as a separate asset, as appropriate,
only when it is probable that future economic benefits associated with the item will flow to the Group and the cost
of the item can be measured reliably. The carrying amount of any component accounted for as a separate asset is
derecognized when replaced. All other repairs and maintenance are charged to profit or loss during the reporting
period in which they are incurred.
Depreciation is calculated using the straight-line method to allocate their cost or revalued amounts, net of their
residual values, over their estimated useful lives as follows:
Estimated useful lives
Office 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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185 years
Electronic 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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183 years
Laboratory 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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185 years
Leasehold improvement /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182-5 years
The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at the end of each
reporting period.
An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying
amount is greater than its estimated recoverable amount.
Gains and losses on disposals are determined by comparing proceeds with carrying amount. These are included
in the consolidated statement of comprehensive loss. When revalued assets are sold, it is group policy to transfer any
amounts included in other reserves in respect of those assets to retained earnings.
APPENDIX I ACCOUNTANT’S REPORT
– I-26 –


--- page 608 ---
(ii) Impairment
Property, plant and equipment are tested for impairment whenever events or changes in circumstances indicate
that the carrying amount may not be recoverable. An impairment loss is recognized for the amount by which the
asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of an asset’s fair value
less costs of disposal and value in use. For the purposes of assessing impairment, assets are grouped at the lowest
levels for which there are separately identifiable cash inflows which are largely independent of the cash inflows from
other assets or groups of assets (CGU). Non-financial assets that suffered an impairment are reviewed for possible
reversal of the impairment at the end of each reporting period.
Group
Non-current
Office
equipment
Electronic
equipment
Laboratory
equipment
Leasehold
improvement
Construction
in progress Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At 1 January 2023
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118121 508 – 220 1,992 2,841
Accumulated depreciation /H1118/H1118/H1118/H1118/H1118(36) (216) – (78) – (330)
Net book amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111885 292 – 142 1,992 2,511
Y ear ended 31 December 2023
Opening net book amount /H1118/H1118/H1118/H1118/H111885 292 – 142 1,992 2,511
Transfers /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11187 – 1,624 2,872 (4,503) –
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118120 858 4,373 3,236 2,697 11,284
Depreciation charge /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(26) (237) (464) (755) – (1,482)
Closing net book amount /H1118/H1118/H1118/H1118/H1118/H1118186 913 5,533 5,495 186 12,313
At 31 December 2023
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118248 1,366 5,997 6,328 186 14,125
Accumulated depreciation /H1118/H1118/H1118/H1118/H1118(62) (453) (464) (833) – (1,812)
Net book amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186 913 5,533 5,495 186 12,313
Non-current
Office
equipment
Electronic
equipment
Laboratory
equipment
Leasehold
improvement
Construction
in progress Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At 1 January 2024
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118248 1,366 5,997 6,328 186 14,125
Accumulated depreciation /H1118/H1118/H1118/H1118/H1118(62) (453) (464) (833) – (1,812)
Net book amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118186 913 5,533 5,495 186 12,313
Y ear ended 31 December 2024
Opening net book amount /H1118/H1118/H1118/H1118/H1118186 913 5,533 5,495 186 12,313
Transfers /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 905 432 (1,337) –
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 689 1,532 155 1,703 4,079
Depreciation charge /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(45) (499) (1,392) (1,384) – (3,320)
Closing net book amount /H1118/H1118/H1118/H1118/H1118/H1118141 1,103 6,578 4,698 552 13,072
At 31 December 2024
Cost /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118248 2,055 8,434 6,915 552 18,204
Accumulated depreciation /H1118/H1118/H1118/H1118/H1118(107) (952) (1,856) (2,217) – (5,132)
Net book amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118141 1,103 6,578 4,698 552 13,072
APPENDIX I ACCOUNTANT’S REPORT
– I-27 –


--- page 609 ---
Depreciation of the Group charged to consolidated statements of comprehensive loss is analyzed as follows:
Y ear ended December 31
2023 2024
RMB’000 RMB’000
Administrative expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118318 290
Research and development expense /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,164 3,030
1,482 3,320
15 RIGHT-OF-USE ASSETS
Group
The Group leases offices and laboratory for its own use. Information about leases for which the Group is a
lessee is presented below:
Offices and laboratory
RMB’000
As 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/H11187,055
Accumulated depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(2,487)
Net book 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/H1118/H1118/H11184,568
For the year ended 31 December 2023
Opening net book 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/H11184,568
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11184,152
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(3,275)
Closing net book 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/H11185,445
As 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/H111811,207
Accumulated depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5,762)
Net book 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/H1118/H1118/H11185,445
Offices and laboratory
RMB’000
As 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/H111811,207
Accumulated depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5,762)
Net book 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/H1118/H1118/H11185,445
For the year ended 31 December 2024
Opening net book 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/H11185,445
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,368
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(3,290)
Closing net book 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/H11185,523
As 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/H111814,575
Accumulated depreciation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(9,052)
Net book 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/H1118/H1118/H11185,523
APPENDIX I ACCOUNTANT’S REPORT
– I-28 –


--- page 610 ---
(i) Amounts recognized in the consolidated statement of comprehensive loss
The consolidated statements of comprehensive loss contain the following amounts relating to leases:
Y ear ended 31 December
2023 2024
RMB’000 RMB’000
Depreciation charge of right-to-use assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Offices and laboratory /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,275 3,290
Interest expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118188 250
Expenses relating to short-term leases (included in
administrative expenses and research and development
expenses) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/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 42
The total cash outflow for leases in the years ended 31 December 2023 and 2024 were RMB3,706,000 and
RMB3,689,000 respectively.
16 INTANGIBLE ASSETS
Accounting policy for intangible assets
(i) Recognition and subsequent measurement
(a) Software
Computer software is recognized at historical cost and subsequently carried at cost less accumulated
amortization and accumulated impairment losses. The Group amortized on a straight-line basis over their
estimated useful lives of 1-3 years.
(b) Licenses
Certain intangible assets are for license of intellectual properties in development, with non-refundable
upfront payment, milestone payment and royalty payment. Upfront payment is capitalized when paid. The
milestone payment is capitalized as intangible assets when incurred, unless the payment is for outsourced
research and development work which would follow the capitalization policy in Note 16 (c). Royalty payment
would be accrued for in line with the underlying sales and recognized as a cost of sales. However, if the
intangible asset is acquired in a business combination, it is measured at fair value at initial recognition.
In-licenses with finite useful life are amortized using the straight-line basis over the commercial lives
of the underlying products, commencing from the date when the products are put into commercial production.
(c) Research and development
The Group incurs significant costs and efforts on research and development activities. Research
expenditures are charged to the profit or loss as an expense in the period the expenditures are incurred.
Development costs are recognized as assets if they can be directly attributable to a newly developed drug
products and all the following can be demonstrated:
(i) the technical feasibility of completing the intangible assets so that it will be available for use or
sale;
(ii) the intention to complete the intangible asset and use or sell it;
(iii) the ability to use or sell the intangible assets;
(iv) the intangible asset will generate probable future economic benefits;
APPENDIX I ACCOUNTANT’S REPORT
– I-29 –


--- page 611 ---
(v) the availability of adequate technical, financial and other resources to complete the development
and to use or sell the intangible asset; and
(vi) the ability to measure reliably the expenditure attributable to the intangible asset during its
development.
The cost of an internally generated intangible asset is the sum of the expenditures incurred from the date
the asset meets the recognition criteria above to the date when it is available for use. The costs capitalized in
connection with the intangible asset include costs of materials and services used or consumed, employee costs
incurred in the creation of the asset and an appropriate portion of relevant overheads. The Group generally
considers capitalization criteria for internally generated intangible assets is met when obtaining regulatory
approval of new drug license.
Capitalized development expenditures are amortized using the straight-line method over the life of the
related drug products. Amortization shall begin when the asset is available for use. Subsequent to initial
recognition, internally generated intangible assets are reported as cost less accumulated amortization and
accumulated impairment losses (if any).
Development expenditures not satisfying the above criteria are recognized in the profit or loss as
incurred and development expenditures previously recognized as an expense are not recognized as an asset in
a subsequent period.
(ii) Impairment
Expenditure to acquire in-licenses and IPR&D is capitalised at fair value at the acquisition date. Intangible
assets that have an indefinite useful life are not subject to amortization and are tested annually for impairment, or
more frequently if events or changes in circumstances indicate that they might be impaired. An impairment loss is
recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount. The recoverable
amount is the higher of an asset’s fair value less costs of disposal and value in use. For the purposes of assessing
impairment, assets are grouped at the lowest levels for which there are separately identifiable cash inflows which are
largely independent of the cash inflows from other assets or groups of assets (CGU). Non-financial assets that
suffered an impairment are reviewed for possible reversal of the impairment at the end of each reporting period.
Group
In-licenses and
IPR&D Software Total
RMB’000 RMB’000 RMB’000
At 1 January 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111850,825 318 51,143
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111824,218 403 24,621
Amortization charges /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (230) (230)
License out /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(21,421) – (21,421)
Currency translation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118135 – 135
At 31 December 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111853,757 491 54,248
As 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/H111853,757 781 54,538
Accumulated amortization and impairment /H1118/H1118/H1118/H1118/H1118 – (290) (290)
Net book amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111853,757 491 54,248
APPENDIX I ACCOUNTANT’S REPORT
– I-30 –


--- page 612 ---
In-licenses and
IPR&D Software Total
RMB’000 RMB’000 RMB’000
At 1 January 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111853,757 491 54,248
Additions /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111824,902 4,958 29,860
Amortization charges /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (1,260) (1,260)
License out /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(15,439) – (15,439)
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(21,350) – (21,350)
Currency translation /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118178 – 178
At 31 December 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111842,048 4,189 46,237
As 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/H111863,613 5,739 69,352
Accumulated amortization and impairment /H1118/H1118/H1118/H1118/H1118(21,565) (1,550) (23,115)
Net book amount /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111842,048 4,189 46,237
The intangible assets related to in-license and IPR&D are not ready for use and the Group is continuing
research and development work.
Impairment tests were performed in respect of these intangible assets based on the recoverable amount of the
cash-generating unit (“CGU”) to which the intangible asset is related. The appropriate CGU is at the product level.
The impairment test was performed for each pipeline product by engaging an independent appraiser to estimate
fair value less cost to sell as the recoverable amount of each pipeline product. The fair value was based on the
multi-period excess earnings method and the Group estimated the forecast of profit for its pipeline products based
on the timing of clinical development and regulatory approval, commercial ramp up to reach expected peak revenue
potential, and potential license out upfront fee and the length of exclusivity for each pipeline product. The discount
rate used is post-tax and reflects specific risks relating to the relevant products.
The annual impairment test was performed by engaging an independent valuer to estimate the fair value less
cost to sell as the recoverable amount. The fair value is based on the multi-periods excessive earning method with
key assumptions as below, and certain pipeline products are not applicable to impairment tests during the year ended
31 December 2024, given that they were out-licensed already:
DB-1202 As at 31 December
2023 2024
Post-tax discount 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/H111816.0% Not applicable
Revenue growth 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/H1118-5% to 68% Not applicable
Recoverable amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111843,226 Not applicable
Carrying amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,248 –
DB-1312 As at 31 December
2023 2024
Post-tax discount 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/H111816.0% Not applicable
Revenue growth 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/H1118-10% to 199.8% Not applicable
Recoverable amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118202,777 Not applicable
Carrying amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815,439 –
APPENDIX I ACCOUNTANT’S REPORT
– I-31 –


--- page 613 ---
DB-1310 As at 31 December
2023 2024
Post-tax discount 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/H111816.0% 15.0%
Revenue growth 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/H1118-6% to 140% -6% to 140%
Recoverable amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111884,406 238,287
Carrying amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111810,790 10,790
DB-1419 As at 31 December
2023 2024
Post-tax discount 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/H111816.0% 15.0%
Revenue growth 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/H1118-8.7% to 218% -8.7% to 218%
Recoverable amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111874,834 172,888
Carrying amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,349 10,077
DB-1311 As at 31 December
2023 2024
Post-tax discount 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/H111816.0% 15.0%
Revenue growth 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/H1118-10% to 160% -10% to 160%
Recoverable amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118140,526 336,571
Carrying amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,931 5,563
DB-1418 As at 31 December
2023 2024
Post-tax discount 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/H1118Not applicable 15.0%
Revenue growth 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/H1118Not applicable -5% to 333.9%
Recoverable amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Not applicable 66,711
Carrying amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 6,703
DB-1324 As at 31 December
2023 2024
Post-tax discount 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/H1118Not applicable 15.0%
Revenue growth 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/H1118Not applicable -19.6% to 246.1%
Recoverable amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Not applicable 235,392
Carrying amount of CGU (in RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 8,915
APPENDIX I ACCOUNTANT’S REPORT
– I-32 –


--- page 614 ---
Impairment test-sensitivity
The Company performed sensitivity test by increasing 1 percentage point of post-tax discount rate or
decreasing 1 percentage point of revenue growth rate, which management considers are the key assumptions in
determining the recoverable amount of each intangible asset, with all other variables held constant. The impacts on
the amount (in RMB thousand) by which the intangible asset’s recoverable amount above its carrying amount
(headroom) are as below:
DB-1202 As at 31 December
2023 2024
Headroom /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,978 Not applicable
Impact by increasing post-tax discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(16,194) Not applicable
Impact by decreasing revenue growth rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(19,353) Not applicable
DB-1312 As at 31 December
2023 2024
Headroom /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118187,338 Not applicable
Impact by increasing post-tax discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(80,015) Not applicable
Impact by decreasing revenue growth rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(47,233) Not applicable
DB-1310 As at 31 December
2023 2024
Headroom /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111873,616 227,497
Impact by increasing post-tax discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(32,146) (34,228)
Impact by decreasing revenue growth rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(23,873) (28,565)
DB-1419 As at 31 December
2023 2024
Headroom /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111871,485 162,811
Impact by increasing post-tax discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(26,473) (30,023)
Impact by decreasing revenue growth rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(14,653) (17,544)
DB-1311 As at 31 December
2023 2024
Headroom /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118137,595 331,008
Impact by increasing post-tax discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(44,266) (48,098)
Impact by decreasing revenue growth rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(33,000) (39,443)
DB-1418 As at 31 December
2023 2024
Headroom /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Not applicable 60,008
Impact by increasing post-tax discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Not applicable (19,587)
Impact by decreasing revenue growth rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Not applicable (10,488)
APPENDIX I ACCOUNTANT’S REPORT
– I-33 –


--- page 615 ---
DB-1324 As at 31 December
2023 2024
Headroom /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Not applicable 226,477
Impact by increasing post-tax discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Not applicable (6,820)
Impact by decreasing revenue growth rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Not applicable (3,535)
Based on the result of the above assessment, there was no impairment for the in-licenses and IPR&D as at
31 December 2023. Considering there was sufficient headroom based on the assessment, except for DB-1202 which
was terminated and fully impaired due to change in market condition during the year ended 31 December 2024, the
directors and management believe that a reasonably possible change in any of the key assumptions would not cause
the relevant carrying amount of the CGU to exceed its recoverable amount, and there was no impairment as at
31 December 2024.
17 CASH AND BANK BALANCES
Group
As at 31 December
2023 2024
RMB’000 RMB’000
Cash in bank and on hand /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,130,889 1,390,672
Less: term deposits with initial term over three months
(Note 19) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (181,766)
Cash and cash equivalents (a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,130,889 1,208,906
(a) All cash in bank are deposits with original maturity within 3 months. The Group earns interest on
cash in bank.
As at 31 December
2023 2024
RMB’000 RMB’000
Cash and cash equivalents are denominated in:
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118558,170 943,255
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118570,485 263,666
EUR /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11182,234 1,985
1,130,889 1,208,906
Company
As at 31 December
2023 2024
RMB’000 RMB’000
Cash in bank and on hand (a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,201 1,885
APPENDIX I ACCOUNTANT’S REPORT
– I-34 –


--- page 616 ---
(a) All cash in bank are deposits with original maturity within 3 months. The Group earns interest on
cash in bank.
As at 31 December
2023 2024
RMB’000 RMB’000
Cash in bank and on hand are denominated in:
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11186,201 1,885
18 RESTRICTED CASH
As at 31 December 2023 and 2024, all the restricted deposits were denominated in USD and held in designated
bank accounts mainly as security deposits for derivative financial instruments.
19 TERM DEPOSITS WITH INITIAL TERM OVER THREE MONTHS
Term deposits with initial term over three months which represented bank deposits in USD with a maturity of
more than three months and less than one year was nil and RMB181,766,000 as at 31 December 2023 and 2024.
20 TRADE RECEIV ABLES
Group
As at 31 December
2023 2024
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,888 379,545
Less: provision for impairment of trade receivables /H1118/H1118/H1118/H1118/H1118/H1118/H1118(85) (524)
Trade receivables – net /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,803 379,021
Customers are generally granted with credit terms ranging from 12 to 45 days.
As at 31 December 2023 and 2024, the ageing analysis of trade receivables based on invoices date and net of
expected credit losses is as follows:
As at 31 December
2023 2024
RMB’000 RMB’000
Within 30 days /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,803 377,783
31 days to 60 days /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 1,238
100,803 379,021
The carrying amounts of the Group’s trade receivables are denominated in RMB and approximate their fair
values.
APPENDIX I ACCOUNTANT’S REPORT
– I-35 –


--- page 617 ---
The credit loss allowance as at 31 December 2023 and 2024 was determined as follows for trade receivables:
As at 31 December
2023 2024
RMB’000 RMB’000
Provision on collective basis
Expected credit loss rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11180.08% 0.14%
Gross carrying amount (RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118100,888 379,545
Credit loss allowance (RMB’000) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(85) (524)
Impairment losses on trade receivables are presented as credit loss allowance within operating loss. Subsequent
recoveries of amounts previously written off are credited against the same line item. Movements on the Group’s credit
loss allowance for trade receivables are as follows:
As at 31 December
2023 2024
RMB’000 RMB’000
Loss allowance
At beginning of the year /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111828 5
Increase in loss allowance recognized in the consolidated
statements of profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111883 439
At end of 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/H111885 524
Trade receivables are written off when there is no reasonable expectation of recovery. Indicators that there is
no reasonable expectation of recovery include, amongst others, the failure of a debtor to engage in a repayment plan
with the Group, and a failure to make contractual payment.
21 PREPAYMENTS AND OTHER RECEIV ABLES
Group
As at 31 December
2023 2024
RMB’000 RMB’000
Prepayments to suppliers /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,746 14,057
Deposits /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,264 6,290
Deferred listing expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 4,205
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111814 46
27,024 24,598
APPENDIX I ACCOUNTANT’S REPORT
– I-36 –


--- page 618 ---
22 OTHER CURRENT ASSETS AND OTHER NON-CURRENT ASSETS
Group
As at 31 December
2023 2024
RMB’000 RMB’000
Other current assets
V alue-added tax recoverable /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111832,534 70,389
Other non-current assets
Tax deduction related to withholding tax (i) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111893,666 115,400
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118342 155
94,008 115,555
(i) The overseas income made by the Group’s PRC subsidiaries will normally be subject to withholding tax.
During the Track Record Period, certain overseas customers withheld excessive tax without considering
the relevant bilateral tax treaties. The receivables in relation to such excessive withholding tax are
RMB93,666,000 and RMB115,400,000 as at 31 December 2023 and 2024, respectively.
The withholding tax receivable from the Federal Central Tax Office represents excess withholding tax
withheld and paid by overseas collaboration partner, BioNTech SE, of Duality Suzhou in Germany based
on the normal statutory withholding tax rate of 15.825%. According to the double tax treaty between
China and Germany, Duality Suzhou, as the recipient of the payment and a Chinese tax resident, is
eligible to apply for a reduced withholding tax rate of 10% under Article 12 of the double tax treaty
between China and Germany.
Duality Suzhou has submitted an application for this treaty benefit and received a formal withholding
tax exemption certificate issued by the Federal Central Tax Office. The certificate confirms that Duality
Suzhou (as the creditor of the payment) is entitled to the reduced withholding tax rate of 10% for license
payments made by BioNTech SE.
The refund process for the portion of withholding tax is currently ongoing. No issues are anticipated
regarding the recoverability of the withholding tax recoverable.
23 SHARE CAPITAL
Group and Company
Authorized
Number of
Ordinary
Shares
Number of
Series Seed
Preferred
Shares
Number of
Series A-1
Preferred
Shares
Number of
Series A-2
Preferred
Shares
Number of
Series B-1
Preferred
Shares
Number of
Series B-2
Preferred
Shares
Equivalent
Nominal
Value
RMB’000
At 31 December 2023 and
2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118139,895,836 5,000,000 12,333,333 2,666,667 16,666,666 23,437,498 137
APPENDIX I ACCOUNTANT’S REPORT
– I-37 –


--- page 619 ---
Issued
The Company was incorporated in the Cayman Islands as an exempted company registered under the
laws of the Cayman Islands on 3 July 2019. Upon incorporation of the Company, 8,000,000 shares were issued
at par value of USD0.0001 each.
Number of Ordinary
Shares
Equivalent Nominal
Value of Ordinary
Shares
RMB’000
At 31 December 2023 and 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,000,000 6
24 OTHER RESERVES
Group
Translation
reserve
Share-based
compensation
Surplus
reserves
Credit risk of
convertible
preferred shares Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At 1 January 2023 /H1118/H1118/H1118/H1118/H1118/H1118(34,232) 10,624 – 7,523 (16,085)
Surplus reserves /H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 45,230 – 45,230
Other comprehensive loss –
resulted from change of
credit risk of convertible
preferred shares /H1118/H1118/H1118/H1118/H1118/H1118– – – (1,688) (1,688)
Currency translation loss /H1118/H1118/H1118 (19,553) – – – (19,553)
Share-based compensation /H1118/H1118 – 23,957 – – 23,957
At 31 December 2023 /H1118/H1118/H1118/H1118(53,785) 34,581 45,230 5,835 31,861
Surplus reserves /H1118/H1118/H1118/H1118/H1118/H1118/H1118– – 39,034 – 39,034
Other comprehensive loss –
resulted from change of
credit risk of convertible
preferred shares /H1118/H1118/H1118/H1118/H1118/H1118– – – (15) (15)
Currency translation loss /H1118/H1118/H1118 (37,950)) – – – (37,950)
Share-based compensation /H1118/H1118 – 190,413 – – 190,413
At 31 December 2024 /H1118/H1118/H1118/H1118(91,735) 224,994 84,264 5,820 223,343
Company
Translation
reserve
Share-based
compensation
Credit risk of
convertible
preferred shares Total
RMB’000 RMB’000 RMB’000 RMB’000
At 1 January 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5,359) 10,624 7,523 12,788
Other comprehensive loss – resulted
from change of credit risk of
convertible preferred shares /H1118/H1118/H1118/H1118 – – (1,688) (1,688)
Currency translation loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5,902) – – (5,902)
Share-based compensation /H1118/H1118/H1118/H1118/H1118/H1118/H1118– 23,957 – 23,957
At 31 December 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(11,261) 34,581 5,835 29,155
Other comprehensive loss – resulted
from change of credit risk of
convertible preferred shares /H1118/H1118/H1118/H1118 – – (15) (15)
Currency translation loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(24,048) – – (24,048)
Share-based compensation /H1118/H1118/H1118/H1118/H1118/H1118/H1118– 190,413 – 190,413
At 31 December 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(35,309) 224,994 5,820 195,505
APPENDIX I ACCOUNTANT’S REPORT
– I-38 –


--- page 620 ---
25 FINANCIAL LIABILITIES AT FAIR V ALUE THROUGH PROFIT OR LOSS
Convertible preferred shares issued by the Company are redeemable upon occurrence of certain future events.
This instrument can be converted into ordinary shares of the Company at any time at the option of the holders or
automatically converted into ordinary shares upon occurrence of an initial public offering (“IPO”) of the Company.
The Group designated the convertible preferred shares as financial liabilities at fair value through profit or
loss. They are initially recognized at fair value. Subsequent to initial recognition, the convertible preferred shares are
carried at fair value with changes in fair value recognized in the consolidated statements of comprehensive loss.
If the Company’s own credit risk results in fair value changes in financial liabilities designated as at fair value
through profit or loss, they are recognized in other comprehensive loss.
Group
As at 31 December
2023 2024
RMB’000 RMB’000
Series Seed Preferred Shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118166,600 253,439
Series A-1 Preferred Shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118417,219 625,157
Series A-2 Preferred Shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111890,203 135,169
Series B-1 Preferred Shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118600,614 844,855
Series B-2 Preferred Shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118858,084 1,188,164
2,132,720 3,046,784
Through March to April 2023, the Company issued 7,366,070 Series B-2 Preferred Shares to certain onshore
investors at a cash consideration of USD22,000,000 (RMB151,101,000), via the following arrangement.
(a) Loans with warrants to purchase Series B-2 Preferred Shares
Prior to investing in the Company, onshore investors shall obtain requisite overseas direct investment
approvals (“ODI approval”). In the Series B-2 financing, prior to obtaining ODI approval, these onshore investors
entered into loan agreements with the Group in 2022 whereby these onshore investors agreed to provide loans to
Duality Biologics (Suzhou) Co., Ltd. (the “WFOE”), a subsidiary of the Company that incorporated in PRC, and the
Company agreed to issue Series B-2 Preferred Share Purchase Warrants (the “Warrants”) to these investors.
Once these onshore investors obtain ODI approval, the WFOE shall return these onshore investors the principal
amount of loans, and such amount shall be paid by these onshore investors to the Company as part of purchase
consideration for Series B-2 Preferred Shares.
These abovementioned loans were designated as financial liabilities at fair value through profit or loss, which
are initially recognized at fair value. The component of fair value changes relating to the Company’s own credit risk
is recognized in other comprehensive income/(loss). Amounts recorded in other comprehensive income/(loss) related
to credit risk are not subject to recycling in profit or loss, but are transferred to retained earnings when realized. Fair
value changes relating to market risk are recognized in profit or loss.
(b) Convertible preferred shares of the Company
The rights, preferences and privileges of the above convertible preferred shares are as follows:
(i) Conversion feature
Each convertible preferred share may, at the option of the holder thereof, be converted at any time after the
date of issuance of such convertible preferred shares into ordinary shares, or shall automatically be converted into
ordinary shares upon the closing of a qualified initial public offering (“QIPO”) of the Company.
APPENDIX I ACCOUNTANT’S REPORT
– I-39 –


--- page 621 ---
The conversion ratio for the convertible preferred shares to the ordinary shares is 1:1 if no adjustments to
conversion price have occurred. As at 31 December 2024, each convertible preferred share is convertible into one
ordinary share.
(ii) Liquidation preferences
Each holder of convertible preferred shares shall be entitled to receive for each series of convertible preferred
shares he or it holds on the preferential basis, prior and in preference to any distribution of any of the assets or surplus
funds of the Company to the holders of other series of convertible preferred shares and ordinary shares or any other
class or series of shares by reason of their ownership of such shares, the amount equal to one hundred percent (100%)
of the respective applicable issue price, plus (a) all interest that would accrue on the applicable issue price during
the period from the relevant issue date to the date of receipt by the holder thereof of the full liquidation amount at
a rate of 10% per annum, plus (b) accrued or declared but unpaid dividends on such convertible preferred shares,
respectively.
If the assets and funds available for distribution shall be insufficient to permit the payment to such holders of
the full preferred preference amount, the liquidation preference amount will be paid to the holders of convertible
preferred shares in the following order: first to holders of Series B-1 and B-2 Preferred Shares (“Series B Preferred
Shares”), second to holders of Series A Preferred Shares, third to holders of Series Seed Preferred Shares, and lastly
to the holders of ordinary shares. After distributing or paying in full the liquidation preference amount to all of the
holders of convertible preferred shares, the remaining assets of the Company available for distribution to members,
if any, shall be distributed to the holders of the ordinary shares on a pro rata basis.
(iii) Redemption feature
The shareholders of Series B Preferred Shares, Series A Preferred Shares and Series Seed Preferred Shares may
give a written notice to the Company at any time or from time to time requesting redemption of all or part of their
convertible preferred shares under certain conditions as provided in the article of association. These conditions
substantially include the following:
(a) the Company fails to complete a QIPO within four (4) years after 23 April 2021, which was the date of
Initial USD Closing as defined in Series B share purchase agreements;
(b) the Company fails to abstain from the occurrence of a deemed liquidation event within four years after
the Initial USD Closing;
(c) other than as approved by the board, the founder terminates his full-time employment relationship with
the Group within four years after the Initial USD Closing;
(d) other than as approved by the board, the founder transfers two thirds or more of the ordinary shares
directly or indirectly held by him as of the Initial USD Closing within four years after the Initial USD
Closing;
(e) the Group fails to maintain, obtain or renew any permits, authorizations, approvals, consents or licenses
necessary to the principal business; or
(f) the occurrence of a material breach, violation or misconduct by the Group or founder parities in its
performance of the relevant transaction documents.
The redemption price payable on each of the abovementioned convertible preferred shares is the applicable
purchase price for each share, plus (a) all interest that would accrue on applicable purchase price during the period
from the relevant issue date to the date of receipt by the holder thereof of the full redemption amount at a rate of
10% or 30% per annum, (b) minus any dividends already paid on each share.
The directors of the Group believes that due to the conversion feature of the convertible preferred shares, the
financial liabilities at fair value through profit or loss will not result in cash payment in the future.
APPENDIX I ACCOUNTANT’S REPORT
– I-40 –


--- page 622 ---
The movement of financial liabilities at fair value through profit or loss is set out below:
Total
RMB’000
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/H1118/H11181,072,720
Issuance of convertible preferred 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/H1118/H1118151,101
Repayments of loans with warrants to purchase Series B Preferred Shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118(135,191)
Changes in fair value – profit or loss (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/H1118/H1118/H11181,017,899
Changes in fair value – other comprehensive loss (2) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,688
Currency translation difference /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111824,503
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/H1118/H11182,132,720
Changes in fair value – profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118873,416
Changes in fair value – other comprehensive loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815
Currency translation difference /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111840,633
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/H1118/H11183,046,784
(1) Through March to April 2023, the Company received total consideration of USD22,000,000
(RMB151,101,000) by issuance of the 7,366,070 Series B-2 Preferred Shares with Warrants exercised
(Note 25(a)).
(2) The fair value change of financial liabilities at fair value through profit or loss in relation with these
Warrants before the issuance dates of Series B-2 Preferred Shares were approximately USD10,309,000
(RMB70,807,000).
With the assistance from an external valuer appointed by the Group, the Group applied the back-solve method
and discounted cash flow method to determine the underlying equity value of the Company and adopted
option-pricing method and equity allocation model to determine the fair value of the financial instruments issued to
investors. Key assumptions are set out as below:
Unobservable inputs
31 December
2023
31 December
2024 Relationship of unobservable inputs to fair value
Discount rate /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815.0% 14.0% The higher the discount rate, the lower
the fair value of financial instrument
to investors.
V olatility /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111857.7% 51.4% Nonlinear relationships
DLOM /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111822.0% 10.0% The higher the DLOM, the lower the fair
value of financial instrument to
investors.
As of 31 December 2023, increasing/decreasing expected volatility by 5% would increase/decrease the fair
value of financial instruments by RMB845,000 and RMB941,000 respectively. Increasing/Decreasing discount rate
by 1% would decrease/increase the fair value by RMB34,068,000 and RMB34,881,000 respectively.
Increasing/Decreasing DLOM by 1% would decrease/increase the fair value by RMB5,799,000 and RMB5,799,000
respectively.
As of 31 December 2024, increasing/decreasing expected volatility by 5% would increase/decrease the fair
value of financial instruments by RMB20,000 and RMB13,000 respectively. Increasing/Decreasing discount rate by
1% would decrease/increase the fair value by RMB44,618,000 and RMB43,706,000 respectively.
Increasing/Decreasing DLOM by 1% would decrease/increase the fair value by RMB3,339,000 and RMB3,339,000
respectively.
APPENDIX I ACCOUNTANT’S REPORT
– I-41 –


--- page 623 ---
Company
As at 31 December
2023 2024
RMB’000 RMB’000
Series Seed Preferred Shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118166,600 253,439
Series A-1 Preferred Shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118417,219 625,157
Series A-2 Preferred Shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111890,203 135,169
Series B-1 Preferred Shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118600,614 844,855
Series B-2 Preferred Shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118858,084 1,188,164
2,132,720 3,046,784
Total
RMB’000
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/H1118/H1118937,529
Issuance of convertible preferred shares /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118151,101
Changes in fair value – profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,017,899
Changes in fair value – other comprehensive loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,688
Currency translation difference /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111824,503
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/H1118/H11182,132,720
Changes in fair value – profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118873,416
Changes in fair value – other comprehensive loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111815
Currency translation difference /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111840,633
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/H1118/H11183,046,784
26 TRADE PAYABLES
Group
As at 31 December 2023 and 2024, the ageing analysis of trade payables based on invoice date is as
follows:
As at 31 December
2023 2024
RMB’000 RMB’000
Within 6 months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118234,476 670,199
6 months to 12 months /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118338 711
234,814 670,910
APPENDIX I ACCOUNTANT’S REPORT
– I-42 –


--- page 624 ---
27 OTHER PAYABLES
Group
As at 31 December
2023 2024
RMB’000 RMB’000
Staff salaries and welfare payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,587 38,496
Payables for acquisition of property, plant and equipment and
intangible assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11187,408 10,114
Payables for listing expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 8,822
Other taxes payable /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118919 1,718
Payables for financial and consulting services /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,651 390
Recruitment services and other accrued expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–8 5
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,109 1,006
34,674 60,631
The carrying amounts of accruals and other payables of the Group are denominated in the following currencies:
As at 31 December
2023 2024
RMB’000 RMB’000
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111826,584 36,443
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11188,090 24,064
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 124
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/H111834,674 60,631
Company
As at 31 December
2023 2024
RMB’000 RMB’000
Payables to subsidiaries /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 17,948
Payables for listing expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 8,442
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118120 4
120 26,394
The carrying amounts of accruals and other payables of the Company are denominated in the following
currencies:
As at 31 December
2023 2024
RMB’000 RMB’000
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 13,240
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118120 13,030
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/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 124
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/H1118120 26,394
APPENDIX I ACCOUNTANT’S REPORT
– I-43 –


--- page 625 ---
28 DIVIDENDS
No dividend has been paid or declared by the Company or the companies now comprising the Group during
each of the years ended 31 December 2023 and 2024.
29 CASH FLOW INFORMATION
(a) Reconciliation of loss for the year to net cash used in operations
Y ear ended 31 December
2023 2024
RMB’000 RMB’000
Loss before income tax /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(202,249) (1,014,546)
Adjustments for:
– Depreciation of property, plant and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,482 3,320
– Impairment of intangible assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 21,350
– Amortization of intangible assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118230 1,260
– Share-based compensation expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,957 190,413
– Depreciation of right-of-use assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,275 3,290
– Finance 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(34,483) (48,112)
– Finance 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/H1118188 250
– Net foreign exchange gains /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(41,935) (12,273)
– Fair value losses on financial liabilities at fair value
through profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,017,899 873,416
– Losses on disposal of financial assets at fair value through
profit or loss /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,162 –
– Investment 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– (2,248)
– License out of intangible assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111821,421 15,439
Changes in working capital:
– Increase in trade, other receivables and prepayments /H1118/H1118/H1118/H1118 (120,969) (276,769)
– Increase in other current assets /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(9,949) (37,855)
– Increase/(decrease) in contract liabilities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118216,296 112,211
– Increase in trade and other payables /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118154,456 463,063
Cash generated from operating activities /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,030,781 292,209
(b) Reconciliation of liabilities arising from financing activities
Lease liabilities
Financial liabilities
at fair value
through profit
or loss Total
RMB’000 RMB’000 RMB’000
Net debt as at 1 January 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(4,665) (1,072,720) (1,077,385)
Cash flows /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,687 (15,910) (12,223)
Acquisition-leases /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(4,152) – (4,152)
Other changes /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(188) (1,019,587) (1,019,775)
Foreign exchange adjustments /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (24,503) (24,503)
Net debt as at 31 December 2023 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5,318) (2,132,720) (2,138,038)
Cash flows /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11183,647 – 3,647
Acquisition-leases /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(3,368) – (3,368)
Other changes /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(250) (873,431) (873,681)
Foreign exchange adjustments /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– (40,633) (40,633)
Net debt as at 31 December 2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118(5,289) (3,046,784) (3,052,073)
APPENDIX I ACCOUNTANT’S REPORT
– I-44 –


--- page 626 ---
30 COMMITMENTS
(a) Capital commitments
Capital expenditure contracted for by the Group at the balance sheet date but not yet incurred is as follows:
As at 31 December
2023 2024
RMB’000 RMB’000
Property, plant and equipment /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118519 423
519 423
31 RELATED PARTY TRANSACTIONS
Parties are considered to be related in one party has the ability, directly or indirectly, to control the other part
or exercise significant influence over the other party in making financial and operation decisions. Parties are also
considered to be related if they are subject to common control. The following is a summary of the significant
transactions carried out between the Group and its related parties in the ordinary course of business during the years
ended 31 December 2023 and 2024 respectively.
(a) Key management compensation
Compensations for key management other than those for directors as disclosed in Note 32 is set out below.
Y ear ended 31 December
2023 2024
RMB’000 RMB’000
Share-based compensation expenses /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11185,968 50,333
Wages, salaries and bonus /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H111823,406 25,280
Social insurance /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H11181,476 1,527
Other welfare for employees /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118480 672
31,330 77,812
32 DIRECTORS’ BENEFITS AND INTERESTS
(a) Directors’ and senior management’s emoluments
Directors and chief executives’ emoluments for the years ended 31 December 2023 and 2024 are set out as
follows:
Fees Salary
Discretionary
bonus
Share-based
compensation
expenses
Pension
costs
Other
benefits Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Y ear ended
December 31, 2023
Executive directors
Dr. Zhongyuan Zhu (i) /H1118/H1118 – 2,334 1,260 14,665 143 142 18,544
Mr. Shaoren Zhang (ii) /H1118 – 1,364 402 150 143 13 2,072
Ms. Wen Si (iii) /H1118/H1118/H1118/H1118/H1118/H1118– 933 297 18 143 13 1,404
Non-executive directors
Dr. Tao Y u (iv) /H1118/H1118/H1118/H1118/H1118/H1118–––––––
Dr. Xianghong Lin (v) /H1118/H1118 –––––––
– 4,631 1,959 14,833 429 168 22,020
APPENDIX I ACCOUNTANT’S REPORT
– I-45 –


--- page 627 ---
Fees Salary
Discretionary
bonus
Share-based
compensation
expenses
Pension
costs
Other
benefits Total
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Y ear ended December 31,
2024 /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
Executive directors
Dr. Zhongyuan Zhu (i) /H1118/H1118/H1118/H1118/H1118– 2,415 1,144 81,710 144 149 85,562
Mr. Shaoren Zhang (ii) /H1118/H1118/H1118/H1118– 1,567 438 3,185 144 13 5,347
Ms. Wen Si (iii) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118– 991 275 1,928 144 13 3,351
Non-executive directors
Dr. Tao Y u (iv) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118–– – ––––
Mr. Zhiyang Cai (vi) /H1118/H1118/H1118/H1118/H1118/H1118–– – ––––
– 4,973 1,857 86,823 432 175 94,260
(i) Dr. Zhongyuan Zhu, as the founder, was appointed as executive director on 19 February 2020.
(ii) Mr. Shaoren Zhang was appointed as executive director on 23 April 2021.
(iii) Ms. Wen Si was appointed as executive director on 23 April 2021.
(iv) Dr. Tao Y u was appointed as a non-executive director on 23 April 2021.
(v) Dr. Xianghong Lin was appointed as a non-executive director on 13 May 2020 and resigned on 22 July
2024.
(vi) Mr. Zhiyang Cai was appointed as a non-executive director on 12 August 2024.
(b) Directors’ retirement benefits
None of the directors received or will receive any retirement benefits during the years ended 31 December
2023 and 2024.
(c) Directors’ termination benefits
None of the directors received or will receive any termination benefits during the years ended 31 December
2023 and 2024.
(d) Consideration provided to third parties for making available directors’ services
During the years ended 31 December 2023 and 2024, the Company did not pay consideration to any third
parties for making available directors’ services.
(e) Information about loans, quasi-loans and other dealings in favor of directors, bodies corporate
controlled by or entities connected with directors
Same as disclosed in Note 10, there were no loans, quasi-loans and other dealings in favor of directors,
controlled bodies corporate by and connected entities with such directors during the years ended 31 December 2023
and 2024.
(f) Directors’ material interests in transactions, arrangements or contracts
No significant transactions, arrangements and contracts in relation to the Group’s business to which the
Company was a party and in which a director of the Company had a material interest, whether directly or indirectly,
subsisted at the end of the years or at any time during the years ended 31 December 2023 and 2024.
APPENDIX I ACCOUNTANT’S REPORT
– I-46 –


--- page 628 ---
33 SUBSIDIARIES
The details of the subsidiaries of the Group are set out below:
Paid-in-capital/Reserve
Percentage of attributable equity interest
to the Company
As at 31 December As at 31 December
Name
Place and date of
incorporation Principal activities 2023 2024 2023 2024
As at the
date of this
report
(RMB’000) (RMB’000)
DualityBio HK Limited (a) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Hong Kong,
21 January 2020
Investment holding USD1 USD1 100% 100% 100%
Duality Biologics (Suzhou) Co., Ltd. (b) /H1118/H1118/H1118/H1118/H1118PRC,
23 March 2020
Investment holding and pharmaceuticals
research, development and production
USD73,000 USD73,000 100% 100% 100%
Duality Biologics (Shanghai) Co., Ltd. (b) /H1118/H1118/H1118/H1118PRC,
26 April 2020
Pharmaceuticals research, development and
production
RMB70,000 RMB90,000 100% 100% 100%
DualityBio Inc. (c) /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118United States,
3 May 2021
Pharmaceuticals research, development and
production
– – 100% 100% 100%
Beijing Duality Biologics Co., Ltd. (d) /H1118/H1118/H1118/H1118/H1118/H1118PRC,
20 November 2024
Pharmaceuticals research, development and
production
Not applicable – Not applicable 100% 100%
Notes:
(a) The statutory auditor of the subsidiary of the Group for the year ended 31 December 2023 was AYC CPA Limited, certified public accountants register ed in the Hong Kong
and no audited financial statement has been issued for the year ended 31 December 2024 until the date of the report.
(b) The statutory auditor of the subsidiaries of the Group for the year ended 31 December 2023 were Suzhou Genhood C.P .A Co., Ltd, certified public acco untants registered in
the PRC and no audited financial statement has been issued for the year ended 31 December 2024 until the date of the report.
(c) No audited financial statements have been issued for these companies for the years ended 31 December 2023 and 2024, as these entities were not subje ct to any statutory audit
requirements under the relevant rules and regulations in the jurisdiction of incorporation.
(d) In November 2024, the Group acquired the entire equity interests from the shareholders of Beijing Duality Biologics Co., Ltd. No audited financia l statement has been issued
for the year ended 31 December 2024 until the date of the report.
APPENDIX I ACCOUNTANT’S REPORT
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--- page 629 ---
34 SUBSEQUENT EVENTS
There are no material subsequent events undertaken by the Duality Biotherapeutics Group after 31 December
2024.
35 SUMMARY OF OTHER ACCOUNTING POLICIES
35.1 Principles of consolidation and equity accounting
35.1.1 Subsidiaries
Subsidiaries are all entities (including structured entities) over which the Group has control. The Group
controls an entity when the Group is exposed to, or has rights to, variable returns from its involvement with the entity
and has the ability to affect those returns through its power to direct the activities of the entity. Subsidiaries are
consolidated from the date on which control is transferred to the Group. They are deconsolidated from the date that
control ceases.
Inter-company transactions, balances and unrealized gains on transactions between group companies are
eliminated. Unrealized losses are also eliminated unless the transaction provides evidence of an impairment of the
transferred asset. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with
the policies adopted by the Group.
35.2 Foreign currency translation
35.2.1 Functional and presentation currency
Items included in the financial statements of each of the Group’s entities are measured using the currency of
the primary economic environment in which the entity operates (the “functional currency”). The Company’s
functional currency is USD; however the Historical Financial Information are presented in RMB. As the major
operations of the Group are within the PRC, the Group determined to present the Historical Financial Information
in RMB (unless otherwise stated).
35.2.2 Transactions and balances
Foreign currency transactions are translated into the functional currency using the exchange rates prevailing
at the dates of the transactions or valuation where items are re-measured. Foreign exchange gains and losses resulting
from the settlement of such transactions are recognized in consolidated statements of comprehensive loss in the
period in which they arise.
Monetary assets and liabilities denominated in foreign currencies at the year end are re-translated at the
exchange rates prevailing at the balance sheet date. Exchange differences arising upon re-translation at the balance
sheet date are recognized in profit or loss.
All foreign exchange gains and losses are presented in the consolidated statements of comprehensive loss
within “Other gains/losses — net”.
35.2.3 Group companies
The results and balance sheet of all the Group entities (none of which has the currency of a hyperinflationary
economy) that have a functional currency different from the presentation currency are translated into the presentation
currency as follows:
 Assets and liabilities for each statement of financial position are translated at the closing rate;
 Income and expenses for each statement of profit or loss and statement of comprehensive income are
translated at average exchange rate; and
 All resulting exchange differences are recognized in other comprehensive income and accumulated as
“Other reserves” in equity.
APPENDIX I ACCOUNTANT’S REPORT
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--- page 630 ---
35.3 Prepayments and other receivables
Prepayments mainly represent upfront cash payments made to testing companies. Prepayments to testing
companies will be subsequently recorded as research and development expenses in accordance with the applicable
performance requirements.
Prepayments are generally due for settlement within one year or less and therefore are all classified as current
assets.
Other receivables are recognized initially at fair value and subsequently measured at amortized cost using the
effective interest method, less allowance for impairment.
35.4 Cash and cash equivalents
For the purpose of presentation in the statement of cash flows, cash and cash equivalents includes cash on
hand, deposits held at call with financial institutions, other short-term, highly liquid investments with original
maturities of three months or less that are readily convertible to known amounts of cash and which are subject to an
insignificant risk of changes in value.
35.5 Share capital
Ordinary shares are classified as equity. Convertible preferred shares issued to investors are classified as
liabilities based on the respective contract terms (see Note 25).
Incremental costs directly attributable to the issue of new shares are shown in equity as a deduction, net of tax,
from the proceeds.
35.6 Trade and other payables
Trade and other payables mainly represent the obligations to pay for services that have been acquired in the
ordinary course of business from hospitals and clinical trial companies. Trade and other payables are presented as
current liabilities unless payment is not due within one year or less after the reporting period.
Trade and other payables are recognized initially at their fair value and subsequently measured at amortized
cost using the effective interest method.
35.7 Income tax
The income tax expense or credit for the period is the tax payable on the current period’s taxable income based
on the applicable income tax rate for each jurisdiction adjusted by changes in deferred tax assets and liabilities
attributable to temporary differences and to unused tax losses.
Deferred income tax
Deferred income tax is provided in full, using the liability method, on temporary differences arising between
the tax bases of assets and liabilities and their carrying amounts in the Historical Financial Information. However,
deferred tax liabilities are not recognized if they arise from the initial recognition of goodwill. Deferred income tax
is also not accounted for if it arises from initial recognition of an asset or liability in a transaction other than a
business combination that at the time of the transaction affects neither accounting nor taxable profit or loss and does
not give rise to equal taxable and deductible temporary differences. Deferred income tax is determined using tax rates
(and laws) that have been enacted or substantively enacted by the end of the reporting period and are expected to
apply when the related deferred income tax asset is realized or the deferred income tax liability is settled.
Deferred tax assets are recognized only if it is probable that future taxable amounts will be available to utilise
those temporary differences and losses.
Deferred tax liabilities and assets are not recognized for temporary differences between the carrying amount
and tax bases of investments in foreign operations where the company is able to control the timing of the reversal
of the temporary differences and it is probable that the differences will not reverse in the foreseeable future.
APPENDIX I ACCOUNTANT’S REPORT
– I-49 –


--- page 631 ---
Deferred tax assets and liabilities are offset where there is a legally enforceable right to offset current tax assets
and liabilities and where the deferred tax balances relate to the same taxation authority. Current tax assets and tax
liabilities are offset where the entity has a legally enforceable right to offset and intends either to settle on a net basis,
or to realize the asset and settle the liability simultaneously.
Current and deferred tax is recognized in profit or loss, except to the extent that it relates to items recognized
in other comprehensive income or directly in equity. In this case, the tax is also recognized in other comprehensive
income or directly in equity, respectively.
35.8 Employee benefits
35.8.1 Pension obligations
In accordance with the rules and regulations in the PRC, the PRC based employees of the Group participate
in various defined contribution retirement benefit plans organised by the relevant municipal and provincial
governments in the PRC under which the Group and the employees are required to make monthly contributions to
these plans calculated as a percentage of the employees’ salaries, subject to certain ceiling. The municipal and
provincial governments undertake to assume the retirement benefit obligations of all existing and future retired PRC
based employees payable under the plans described above. Other than the monthly contributions, the Group has no
further obligation for the payment of retirement and other post-retirement benefits of its employees. The assets of
these plans are held separately from those of the Group in an independent fund managed by the PRC government.
The Group’s contributions to these plans are expensed as incurred.
35.8.2 Housing funds, medical insurances and other social insurances
The PRC employees of the Group are entitled to participate in various government-supervised housing funds,
medical insurance and other employee social insurance plan. The Group contributes on a monthly basis to these funds
based on certain percentages of the salaries of the employees, subject to certain ceiling. The Group’s liability in
respect of these funds is limited to the contributions payable in each period.
35.8.3 Short-term obligations
Liabilities for wages and salaries, including non-monetary benefits that are expected to be settled wholly
within 12 months after the end of the period in which the employees render the related service are recognized in
respect of employees’ services up to the end of the reporting period and are measured at the amounts expected to be
paid when the liabilities are settled. The liabilities are presented as current employee benefit obligations in the
balance sheet.
35.8.4 Employee leave entitlement
Employee entitlement to annual leave are recognized when they have accrued to employees. A provision is
made for the estimated liability for annual leave as a result of services rendered by employees up to the end of the
reporting period. Employees entitlement to sick leave and maternity leave are not recognized until the time of leave.
35.8.5 Bonus plan
The expected cost of bonus is recognized as a liability when the Group has a present legal or constructive
obligation for payment of bonus as a result of services rendered by employees and a reliable estimate of the obligation
can be made. Liabilities for bonus plans are expected to be settled within 12 months and are measured at the amounts
expected to be paid when they are settled.
35.9 Government grants
Government grants are recognized at their fair value where there is a reasonable assurance that the grant will
be received and the Group will comply with all the attached conditions.
Government grants relating to costs are deferred and recognized in consolidated statements of comprehensive
loss over the period necessary to match them with the costs that they are intended to compensate.
APPENDIX I ACCOUNTANT’S REPORT
– I-50 –


--- page 632 ---
Government grants relating to property, plant and equipment are included in non-current liabilities as deferred
income and are credited to consolidated statements of comprehensive loss over the estimated useful lives of the
related assets using the straight-line method.
35.10 Leases as lessee
The Group leases various properties. Rental contracts are typically made for fixed periods of 1 to 2 years.
Lease terms are negotiated on an individual basis and contain a wide range of different terms and conditions. The
lease agreements do not impose any covenants, but leased assets may not be used as security for borrowing purposes.
Leases are recognized as a right-of-use asset and a corresponding liability at the date at which the leased asset
is available for use by the Group. Each lease payment is allocated between the liability and finance cost. The finance
cost is charged to consolidated statements of comprehensive loss over the lease period so as to produce a constant
periodic rate of interest on the remaining balance of the liability for each period. The right-of-use asset is depreciated
over the shorter of the asset’s useful life and the lease term on a straight-line basis.
Assets and liabilities arising from a lease are initially measured on a present value basis. Lease liabilities
include the net present value of the following lease payments:
 fixed payments (including in-substance fixed payments), less any lease incentives receivable; and
 the lease payments are discounted using the interest rate implied in the lease, if that rate can be
determined, or the respective incremental borrowing rate.
Right-of-use assets are measured at cost comprising the following:
 the amount of the initial measurement of lease liabilities;
 payments associated with short-term leases are recognized on a straight-line basis as an expense in
consolidated statements of comprehensive loss. Short-term leases are leases with a lease term of 12
months or less.
III SUBSEQUENT FINANCIAL STATEMENTS
No audited financial statements have been prepared for the Company or any of the
companies comprising the Group in respect of any period subsequent to 31 December 2024 and
up to the date of this report. No dividend or distribution has been declared, made or paid by
the Company or any of the companies comprising the Group in respect of any period
subsequent to 31 December 2024.
APPENDIX I ACCOUNTANT’S REPORT
– I-51 –


--- page 633 ---
The following information does not form part of the Accountant’ s Report from
PricewaterhouseCoopers, Certified Public Accountants, the reporting accountant of the
Company, as set forth in Appendix I to this prospectus, and is included herein for information
only. The unaudited pro forma financial information should be read in conjunction with
“Financial Information” and the Accountant’ s Report set forth in Appendix I to this
prospectus.
A. UNAUDITED PRO FORMA STATEMENT OF ADJUSTED CONSOLIDATED 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 for illustrative
purposes only, and is set out below to illustrate the effect of the Global Offering on the net
tangible assets of the Group attributable to the owners of the Company as of 31 December 2024
as if the Global Offering had taken place on 31 December 2024.
This 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 give
a true picture of the consolidated net tangible assets of the Group as of 31 December 2024 or
at any future dates following the Global Offering.
Audited
consolidated net
tangible liabilities
of the Group
attributable to
owners of the
Company as of
31 December 2024
Estimated net
proceeds from
the Global
Offering
Estimated Impact
Related to the
Conversion of the
Preferred Shares
of the Company
upon the
Completion of the
Global Offering
Unaudited pro
forma adjusted
consolidated net
tangible assets
attributable to
owners of the
Company as of
31 December 2024
Unaudited pro forma
adjusted consolidated
net tangible assets
per Share
(Note 1) (Note 2) (Note 3) (Note 4) (Note 5)
RMB’000 RMB’000 RMB’000 RMB’000 RMB HK$
Based on the Offer Price of
HK$94.60 per Share /H1118/H1118/H1118 (2,068,136) 1,231,440 3,046,784 2,210,088 26.57 28.79
Based on the Offer Price of
HK$103.20 per Share /H1118/H1118 (2,068,136) 1,345,647 3,046,784 2,324,295 27.94 30.28
Notes:
(1) The audited consolidated net tangible liabilities of the Group attributable to the owners of the Company as of
31 December 2024 is extracted from the Accountant’s Report set out in Appendix I to this prospectus, which
is based on the unaudited consolidated net liabilities of the Group attributable to owners of the Company as
of 31 December 2024 of approximately RMB2,021,899,000, with an adjustment for the Group’s net intangible
assets attributable to owners of the Company of approximately RMB46,237,000 as of 31 December 2024.
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-1 –


--- page 634 ---
(2) The estimated net proceeds from the Global Offering are based on 15,071,600 Offer Shares expected to be
issued under the Global Offering and the indicative Offer Prices of HK$94.60 and HK$103.20 per Offer Share,
being the low and high end of the indicative price range, after deduction of the underwriting fees and other
related expenses (excluding listing expenses of RMB24,145,000 which have been accounted for in the
consolidated income statements prior to 31 December 2024) and takes no account of any Ordinary Shares
which may be allotted and issued by the Company pursuant to the exercise of the Offer Size Adjustment Option
and the Over-allotment Option or any Shares which may be issued by the Company pursuant to the Pre-IPO
Equity Incentive Plan, or any Shares which may be issued or repurchased by the Company under the general
mandates granted to our Directors as described in “Share Capital”.
(3) Upon the completion of the Global Offering, all the convertible preferred shares of the Company will be
automatically converted into Ordinary Shares. These convertible preferred shares of the Company will be
re-designated from liabilities to equity. Accordingly, for the purpose of the unaudited pro forma financial
information, the unaudited pro forma adjusted consolidated net tangible assets attributable to the owners of the
Company will be increased by approximately RMB3,046,784,000, being the carrying amount of the
convertible preferred shares of the Company as at 31 December 2024.
(4) The unaudited pro forma adjusted consolidated net tangible assets per Share is arrived at after the adjustments
referred to in the preceding paragraphs and on the basis that 83,175,764 Shares (representing 8,000,000
Ordinary Shares and 60,104,164 Pre-IPO Preferred Shares as at 31 December 2024, and 15,071,600 Offer
Shares to be issued upon the completion of the Global Offering) were in issue, assuming that the Global
Offering and the conversion of the convertible preferred shares of the Company in paragraph (3) had been
completed on 31 December 2024 but does not take into account any Ordinary Shares which may be allotted
and issued by the Company pursuant to the exercise of the Offer Size Adjustment Option and the
Over-allotment Option or any Shares which may be issued pursuant to the Pre-IPO Equity Incentive Plan, or
any Shares which may be issued or repurchased by the Company under the general mandates granted to our
Directors as described in “Share Capital”.
(5) For the purpose of the unaudited pro forma statement of adjusted consolidated net tangible assets, the
translation of Hong Kong dollars amounts into Renminbi was at rate of HK$1.00 to RMB0.9227, as set out
in the section headed “Information about this Prospectus and the Global Offering”. No representation is made
that Hong Kong dollar amounts have been, could have been or may be converted to Renminbi, or vice versa,
at that date.
(6) No 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 31 December 2024.
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-2 –


--- page 635 ---
B. REPORT FROM THE REPORTING ACCOUNTANT ON THE UNAUDITED PRO
FORMA FINANCIAL INFORMATION
The following is the text of a report received from PricewaterhouseCoopers, Certified
Public Accountants, Hong Kong, for the purpose of incorporation in this prospectus.
INDEPENDENT REPORTING ACCOUNTANT’S ASSURANCE REPORT ON THE
COMPILATION OF UNAUDITED PRO FORMA FINANCIAL INFORMATION
To the Directors of Duality Biotherapeutics, Inc.
We have completed our assurance engagement to report on the compilation of unaudited
pro forma financial information of Duality Biotherapeutics, Inc. (the “Company”) and its
subsidiaries (collectively the “Group”) by the directors of the Company (the “Directors”) for
illustrative purposes only. The unaudited pro forma financial information consists of the
unaudited pro forma statement of adjusted consolidated net tangible assets of the Group as at
31 December 2024, and related notes (the “Unaudited Pro Forma Financial Information”) as set
out on pages II-1 to II-2 of the Company’s prospectus dated 7 April 2025, in connection with
the proposed initial public offering of the shares of the Company (the “Prospectus”). The
applicable criteria on the basis of which the Directors have compiled the Unaudited Pro Forma
Financial Information are described on pages II-1 to II-2 of the Prospectus.
The Unaudited Pro Forma Financial Information has been compiled by the Directors to
illustrate the impact of the proposed initial public offering on the Group’s financial position as
at 31 December 2024 as if the proposed initial public offering had taken place at 31 December
2024. As part of this process, information about the Group’s financial position has been
extracted by the Directors from the Group’s financial information for the period ended
31 December 2024, on which an accountant’s report has been published.
Directors’ Responsibility for the Unaudited Pro Forma Financial Information
The Directors are responsible for compiling the Unaudited Pro Forma Financial
Information in accordance with paragraph 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 7, Preparation of Pro Forma Financial Information for Inclusion in
Investment Circulars (“AG 7”) issued by the Hong Kong Institute of Certified Public
Accountants (“HKICPA”).
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-3 –


--- page 636 ---
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 behaviour.
Our firm applies Hong Kong Standard on Quality Management (HKSQM) 1, Quality
Management for Firms that Perform Audits or Reviews of Financial Statements, or Other
Assurance or Related Services Engagements , issued by the HKICPA, 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.
Reporting Accountant’s Responsibilities
Our responsibility is to express an opinion, as required by paragraph 4.29(7) of the
Listing Rules, on the Unaudited 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 Unaudited 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 accountant plans and performs procedures to obtain reasonable assurance
about whether the Directors have compiled the Unaudited Pro Forma Financial Information in
accordance with paragraph 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 Unaudited 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 Unaudited Pro Forma
Financial Information.
The purpose of unaudited pro forma financial information included in a prospectus is
solely to illustrate the impact of a significant event or transaction on unadjusted financial
information of the entity as if the event had occurred or 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 proposed initial public offering at 31 December 2024
would have been as presented.
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-4 –


--- page 637 ---
A reasonable assurance engagement to report on whether the unaudited 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 unaudited pro forma financial information provide a reasonable basis
for presenting the significant effects directly attributable to the event or transaction, and to
obtain sufficient appropriate evidence about whether:
 The related pro forma adjustments give appropriate effect to those criteria; and
 The unaudited pro forma financial information reflects the proper application of
those adjustments to the unadjusted financial information.
The procedures selected depend on the reporting accountant’s judgment, having regard to
the reporting accountant’s understanding of the nature of the company, the event or transaction
in respect of which the unaudited pro forma financial information has been compiled, and other
relevant engagement circumstances.
The engagement also involves evaluating the overall presentation of the unaudited pro
forma financial information.
We believe that the evidence we have obtained is sufficient and appropriate to provide a
basis for our opinion.
Our work has not been carried out in accordance with auditing standards or other
standards and practices generally accepted in the United States of America or auditing
standards of the Public Company Accounting Oversight Board (United States) or standards and
practices of any professional body in any other overseas jurisdiction and accordingly should
not be relied upon as if it had been carried out in accordance with those standards and practices.
Opinion
In our opinion:
(a) the Unaudited Pro Forma Financial Information has been properly compiled by the
Directors on the basis stated;
(b) such basis is consistent with the accounting policies of the Group; and
(c) the adjustments are appropriate for the purposes of the Unaudited Pro Forma
Financial Information as disclosed pursuant to paragraph 4.29(1) of the Listing
Rules.
PricewaterhouseCoopers
Certified Public Accountants
Hong Kong, 7 April, 2025
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Set out below is a summary of certain provisions of the constitution of the Company and
certain aspects of the company laws of the Cayman Islands.
The Company was incorporated in the Cayman Islands as an exempted company with
limited liability on July 3, 2019 under the Companies Act. The Company’s constitutional
documents consist of the Memorandum of Association and the Articles of Association.
1. MEMORANDUM OF ASSOCIATION
The Memorandum provides, inter alia , that the liability of the members of the Company
is limited, that the objects for which the Company is established are unrestricted (and therefore
include acting as an investment holding company) and that the Company shall have full power
and authority to carry out any object not prohibited by the Companies Act or any other law of
the Cayman Islands.
2. ARTICLES OF ASSOCIATION
The Articles were conditionally adopted on April 1, 2025 and will become effective on the
Listing Date. A summary of certain provisions of the Articles is set out below.
2.1 Shares
(a) Classes of Shares
The share capital of the Company consists of a single class of ordinary shares.
(b) V ariation of Rights of Existing Shares or Classes of Shares
If at any time the share capital of the Company is divided into different classes of Shares,
all or any of the rights attached to any class of Shares for the time being issued (unless
otherwise provided by the terms of issue of the Shares of that class) may, whether or not the
Company is being wound up, be varied with the consent in writing of the holders of at least
three-fourths of the issued Shares of that class, or with the approval of a resolution passed by
at least three-fourths of the votes cast by the holders of the Shares of that class present and
voting in person (whether physically or by virtual attendance with the use of technology) or by
proxy at a separate meeting of such holders. The provisions of the Articles relating to general
meetings shall apply mutatis mutandis to every such separate meeting, except that the
necessary quorum shall be two persons together holding (or, in the case of a member being a
corporation, by its duly authorised representative), or representing by proxy, at least one-third
of the issued Shares of that class. Every holder of Shares of the class shall be entitled on a poll
to one vote for every such Share held by him, and any holder of Shares of the class present in
person (whether physically or by virtual attendance with the use of technology), or, by proxy
may demand a poll.
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For the purposes of a separate class meeting, the Board may treat two or more classes of
Shares as forming one class of Shares if the Board considers that such classes of Shares would
be affected in the same way by the proposals under consideration, but in any other case shall
treat them as separate classes of Shares.
Any rights conferred upon the holders of Shares of any class shall not, unless otherwise
expressly provided in the rights attaching to the terms of issue of the Shares of that class, be
deemed to be varied by the creation or issue of further Shares ranking pari passu therewith.
(c) Alteration of Capital
The Company may by ordinary resolution:
(i) increase its share capital by the creation of new Shares of such amount and with such
rights, priorities and privileges attached to such Shares as it may determine;
(ii) consolidate and divide all or any of its share capital into Shares of a larger amount
than its existing Shares. On any consolidation of fully paid Shares and division into
Shares of a larger amount, the Board may settle any difficulty which may arise as
it thinks expedient and, in particular (but without prejudice to the generality of the
foregoing), may as between the holders of Shares to be consolidated determine
which particular Shares are to be consolidated into a consolidated Share, and if it
shall happen that any person shall become entitled to fractions of a consolidated
Share or Shares, such fractions may be sold by some person appointed by the Board
for that purpose and the person so appointed may transfer the Shares so sold to the
purchaser(s) thereof and the validity of such transfer shall not be questioned, and the
net proceeds of such sale (after deduction of the expenses of such sale) may either
be distributed among the persons who would otherwise be entitled to a fraction or
fractions of a consolidated Share or Shares rateably in accordance with their rights
and interests or may be paid to the Company for the Company’s benefit;
(iii) sub-divide its Shares or any of them into Shares of an amount smaller than that fixed
by the Memorandum; and
(iv) cancel any Shares which, as at the date of passing of the resolution, have not been
taken or agreed to be taken by any person and diminish the amount of its share
capital by the amount of the Shares so cancelled.
The Company may by special resolution reduce its share capital or any undistributable
reserve, subject to the provisions of the Companies Act.
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(d) Transfer of Shares
Subject to the terms of the Articles, any member of the Company may transfer all or any
of his Shares by an instrument of transfer. If the Shares in question were issued in conjunction
with rights, options, warrants or units issued pursuant to the Articles on terms that one cannot
be transferred without the other, the Board shall refuse to register the transfer of any such Share
without evidence satisfactory to it of the like transfer of such right, option, warrant or unit.
Subject to the Articles and the requirements of the Stock Exchange, all transfers of Shares
shall be effected by an instrument of transfer in the usual or common form or in such other
form as the Board may approve and may be under hand or, if the transferor or transferee is a
recognised clearing house or its nominee(s), under hand or by machine imprinted signature, or
by such other manner of execution as the Board may approve from time to time.
Execution of the instrument of transfer shall be by or on behalf of the transferor and the
transferee, provided that the Board may dispense with the execution of the instrument of
transfer by the transferor or transferee or accept mechanically executed transfers. The
transferor shall be deemed to remain the holder of a Share until the name of the transferee is
entered in the register of members of the Company in respect of that Share.
Subject to the provisions of the Companies Act, if the Board considers it necessary or
appropriate, the Company may establish and maintain a branch register or registers of members
at such location or locations within or outside the Cayman Islands as the Board thinks fit. The
Board may, in its absolute discretion, at any time transfer any Share on the principal register
to any branch register or any Share on any branch register to the principal register or any other
branch register.
The Board may, in its absolute discretion, decline to register a transfer of any Share (not
being a fully paid Share) to a person of whom it does not approve or on which the Company
has a lien, or a transfer of any Share issued under any share option scheme upon which a
restriction on transfer subsists or a transfer of any Share to more than four joint holders. It may
also decline to recognise any instrument of transfer if the proposed transfer does not comply
with the Articles or any requirements of the Listing Rules.
The Board may decline to recognise any instrument of transfer unless a certain fee, up to
such maximum sum as the Stock Exchange may determine to be payable, is paid to the
Company, the instrument of transfer is properly stamped (if applicable), is in respect of only
one class of Share and is lodged at the relevant registration office or the place at which the
principal register is located accompanied by the relevant share certificate(s) and such other
evidence as the Board may reasonably require is provided to show the right of the transferor
to make the transfer (and if the instrument of transfer is executed by some other person on his
behalf, the authority of that person so to do).
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The register of members may, subject to the Listing Rules and the relevant section of the
Companies Ordinance, be closed at such time or for such period not exceeding in the whole 30
days in each year as the Board may determine (or such longer period as the members of the
Company may by ordinary resolution determine, provided that such period shall not be
extended beyond 60 days in any year).
Fully paid Shares shall be free from any restriction on transfer (except when permitted by
the Stock Exchange) and shall also be free from all liens.
(e) Redemption of Shares
Subject to the provisions of the Companies Act, the Listing Rules and any rights conferred
on the holders of any Shares or attaching to any class of Shares, the Company may issue Shares
that are to be redeemed or are liable to be redeemed at the option of the members or the
Company. The redemption of such Shares shall be effected in such manner and upon such other
terms as the Company may by special resolution determine before the issue of such Shares.
(f) Power of the Company to Purchase its own Shares
Subject to the Companies Act, or any other law or so far as not prohibited by any law and
subject to any rights conferred on the holders of any class of Shares, the Company shall have
the power to purchase or otherwise acquire all or any of its own Shares (which includes
redeemable Shares), provided that the manner and terms of purchase have first been authorised
by ordinary resolution and that any such purchase shall only be made in accordance with the
relevant code, rules or regulations issued from time to time by the Stock Exchange and/or the
Securities and Futures Commission of Hong Kong from time to time in force.
(g) Power of any Subsidiary of the Company to own Shares in the Company
There are no provisions in the Articles relating to the ownership of Shares in the Company
by a subsidiary.
(h) Calls on Shares and Forfeiture of Shares
Subject to the terms of allotment and issue of any Shares (if any), the Board may, from
time to time, make such calls as it thinks fit upon the members in respect of any monies unpaid
on the Shares held by them (whether in respect of par value or share premium). A member who
is the subject of the call shall (subject to receiving at least 14 clear days’ notice specifying the
time or times for payment) pay to the Company at the time or times so specified the amount
called on his Shares. A call may be made payable either in one sum or by instalments, and shall
be deemed to have been made at the time when the resolution of the Board authorising such
call was passed. The joint holders of a Share shall be severally as well as jointly liable for the
payment of all calls and instalments due in respect of such Share.
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If a call remains unpaid after it has become due and payable, the member from whom the
sum is due shall pay interest on the unpaid amount at such rate as the Board shall determine
(together with any expenses incurred by the Company as a result of such non-payment) from
the day it became due and payable until it is paid, but the Board may waive payment of such
interest or expenses in whole or in part.
If a member fails to pay any call or instalment of a call after it has become due and
payable, the Board may, for so long as any part of the call or instalment remains unpaid, give
to such member not less than 14 clear days’ notice requiring payment of the unpaid amount
together with any interest which may have accrued and which may still accrue up to the date
of payment (together with any expenses incurred by the Company as a result of such
non-payment). The notice shall specify a further day on or before which the payment required
by the notice is to be made. The notice shall also state that, in the event of non-payment at or
before the appointed time, the Shares in respect of which the call was made will be liable to
be forfeited.
If such notice is not complied with, any Share in respect of which the notice was given
may, before the payment required by the notice has been made, be forfeited by a resolution of
the Board. Such forfeiture shall include all dividends, other distributions and other monies
payable in respect of the forfeited Share and not paid before the forfeiture.
A person whose Shares have been forfeited shall cease to be a member in respect of the
forfeited Shares, shall surrender to the Company for cancellation the certificate(s) for the
Shares forfeited and shall remain liable to pay to the Company all monies which, as at the date
of forfeiture, were payable by him to the Company in respect of the Shares together with (if
the Board shall in its discretion so require) interest thereon from the date of forfeiture until the
date of payment as the Board may determine and any expenses incurred by the Company as a
result of such non-payment.
2.2 Directors
(a) Appointment, Retirement and Removal
The Company may by ordinary resolution of the members elect any person to be a
Director. The Board may also appoint any person to be a Director at any time, either to fill a
casual vacancy or as an additional Director subject to any maximum number fixed by the
members in general meeting or the Articles. Any Director so appointed shall hold office only
until the first annual general meeting of the Company after his appointment and shall then be
eligible for re-election at such meeting. Any Director so appointed by the Board shall not be
taken into account in determining the Directors or the number of Directors who are to retire
by rotation at an annual general meeting.
There is no shareholding qualification for Directors nor is there any specified age limit
for Directors.
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The members may by ordinary resolution remove any Director (including a managing or
executive Director) before the expiration of his term of office, notwithstanding anything in the
Articles or any agreement between the Company and such Director, and may by ordinary
resolution elect another person in his stead. Nothing shall be taken as depriving a Director so
removed of any compensation or damages payable to such Director in respect of the
termination of his appointment as Director or of any other appointment or office as a result of
the termination of his appointment as Director.
The office of a Director shall be vacated if:
(i) the Director gives notice in writing to the Company that he resigns from his office
as Director;
(ii) the Director is absent, without being represented by proxy or an alternate Director
appointed by him, for a continuous period of 12 months without special leave of
absence from the Board, and the Board passes a resolution that he has by reason of
such absence vacated his office;
(iii) the Director becomes bankrupt or has a receiving order made against him or
suspends payment or compounds with his creditors generally;
(iv) the Director dies or an order is made by any competent court or official on the
grounds that he is or may be suffering from mental disorder or is otherwise
incapable of managing his affairs and the Board resolves that his office be vacated;
(v) the Director is prohibited from being or ceases to be a Director by operation of law;
(vi) the Director has been required by the Stock Exchange to cease to be a Director or
no longer qualifies to be a Director pursuant to the Listing Rules; or
(vii) the Director is removed from office by notice in writing served upon him signed by
not less than three-fourths in number (or, if that is not a round number, the nearest
lower round number) of the Directors (including himself) then in office.
At each annual general meeting, one-third of the Directors for the time being shall retire
from office by rotation. If the number of Directors is not a multiple of three, then the number
nearest to but not less than one-third shall be the number of retiring Directors, provided that
every Director shall be subject to retirement by rotation at least once every three years. The
Directors to retire at each annual general meeting shall be those who have been in office
longest since their last re-election or appointment and, as between persons who became or were
last re-elected Directors on the same day, those to retire shall (unless they otherwise agree
among themselves) be determined by lot.
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(b) Power to Allot and Issue Shares and other Securities
Subject to the provisions of the Companies Act, the Memorandum and Articles and, where
applicable, the Listing Rules, and without prejudice to any rights or restrictions for the time
being attached to any Shares, the Board may allot, issue, grant options over or otherwise
dispose of Shares with or without preferred, deferred or other rights or restrictions, whether
with regard to dividend, voting, return of capital or otherwise, to such persons, at such times,
for such consideration and on such terms and conditions as it in its absolute discretion thinks
fit, provided that no Shares shall be issued at a discount to their par value.
The Company may issue rights, options, warrants or convertible securities or securities of
a similar nature conferring the right upon the holders thereof to subscribe for, purchase or
receive any class of Shares or other securities in the Company on such terms as the Board may
from time to time determine.
Neither the Company nor the Board shall be obliged, when making or granting any
allotment of, offer of, option over or disposal of Shares, to make, or make available, any such
allotment, offer, option or Shares to members or others whose registered addresses are in any
particular territory or territories where, in the absence of a registration statement or other
special formalities, this is or may, in the opinion of the Board, be unlawful or impracticable.
However, no member affected as a result of the foregoing shall be, or be deemed to be, a
separate class of members for any purpose whatsoever.
(c) Power to Dispose of the Assets of the Company or any of its Subsidiaries
Subject to the provisions of the Companies Act, the Memorandum and Articles and any
directions given by special resolution of the Company, the Board may exercise all powers and
do all acts and things which may be exercised or done by the Company to dispose of the assets
of the Company or any of its subsidiaries. No alteration to the Memorandum or Articles and
no direction given by special resolution of the Company shall invalidate any prior act of the
Board which would have been valid if such alteration or direction had not been made or given.
(d) Borrowing Powers
The Board may exercise all the powers of the Company to raise or borrow money, secure
the payment of any sum or sums of money for the purposes of the Company, mortgage or
charge all or any part of its undertaking, property and uncalled capital of the Company, and,
subject to the Companies Act, issue debentures, debenture stock, bonds and other securities,
whether outright or as collateral security for any debt, liability or obligation of the Company
or of any third party.
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(e) Remuneration
A Director shall be entitled to receive such sums as shall from time to time be determined
by the Board or the Company in general meetings. The Directors shall also be entitled to be
repaid all expenses reasonably incurred by them in connection with attendance at meetings of
the Board or committees of the Board, or general meetings of the Company or separate
meetings of the holders of any class of Shares or debentures of the Company, or otherwise in
connection with the business of the Company and the discharge of their duties as Directors,
and/or to receive fixed allowances in respect thereof as may be determined by the Board.
The Board or the Company in general meetings may also approve additional remuneration
to any Director for any services which in the opinion of the Board or the Company in general
meetings go beyond such Director’s ordinary routine work as a Director.
(f) Compensation or Payments for Loss of Office
There are no provisions in the Articles relating to compensation or payment for loss of
office.
(g) Loans to Directors
There are no provisions in the Articles relating to making of loans to Directors.
(h) Disclosure of Interest in Contracts with the Company or any of its Subsidiaries
With the exception of the office of auditor of the Company, a Director may hold any other
office or place of profit with the Company in conjunction with his office of Director for such
period and upon such terms as the Board may determine, and may be paid such extra
remuneration for that other office or place of profit, in whatever form, in addition to any
remuneration provided for by or pursuant to the Articles. A Director may be or become a
director, officer or member of any other company in which the Company may be interested, and
shall not be liable to account to the Company or the members for any remuneration or other
benefits received by him as a director, officer or member of such other company.
No person shall be disqualified from the office of Director or alternate Director or
prevented by such office from contracting with the Company, nor shall any such contract or any
other contract or transaction entered into by or on behalf of the Company in which any Director
or alternate Director is in any way interested be or be liable to be avoided, nor shall any
Director or alternate Director so contracting or being so interested be liable to account to the
Company for any profit realised by or arising in connection with any such contract or
transaction by reason of such Director or alternate Director holding such office or of the
fiduciary relationship established by it, provided that the nature of interest of any Director or
alternate Director in any such contract or transaction shall be disclosed by such Director or
alternate Director at or prior to the consideration and vote thereon.
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A Director shall not vote on (or be counted in the quorum in relation to) any resolution
of the Board in respect of any contract or arrangement or other proposal in which he or any of
his close associate(s) has/have a material interest, and if he shall do so his vote shall not be
counted and he shall not be counted in the quorum for such resolution. This prohibition shall
not apply to any of the following matters:
(i) the giving of any security or indemnity to the Director or his close associate(s) in
respect of money lent or obligations incurred or undertaken by him or any of them
at the request of or for the benefit of the Company or any of its subsidiaries;
(ii) the giving of any security or indemnity to a third party in respect of a debt or
obligation of the Company or any of its subsidiaries for which the Director or his
close associate(s) has/have himself/themselves assumed responsibility in whole or
in part whether alone or jointly under a guarantee or indemnity or by the giving of
security;
(iii) any proposal concerning an offer of Shares, debentures or other securities of or by
the Company or any other company which the Company may promote or be
interested in for subscription or purchase, where the Director or his close
associate(s) is/are or is/are to be interested as a participant in the underwriting or
sub-underwriting of the offer;
(iv) any proposal or arrangement concerning the benefit of employees of the Company
or any of its subsidiaries, including the adoption, modification or operation of (A)
any employees’ share scheme or any share incentive or share option scheme under
which the Director or his close associate(s) may benefit or (B) any pension fund or
retirement, death or disability benefits scheme which relates to the Director, his
close associates and employees of the Company or any of its subsidiaries and does
not provide in respect of any Director or his close associate(s) any privilege or
advantage not generally accorded to the class of persons to which such scheme or
fund relates; and
(v) any contract or arrangement in which the Director or his close associate(s) is/are
interested in the same manner as other holders of Shares, debentures or other
securities of the Company by virtue only of his/their interest in those Shares,
debentures or other securities.
2.3 Proceedings of the Board
The Board may meet anywhere in the world for the despatch of business and may adjourn
and otherwise regulate its meetings as it thinks fit. Unless otherwise determined, two Directors
shall be a quorum. Questions arising at any meeting shall be determined by a majority of votes.
In the case of an equality of votes, the chairman of the meeting shall have a second or casting
vote.
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2.4 Alterations to the Constitutional Documents and the Company’s Name
The Memorandum and Articles may only be altered or amended, and the name of the
Company may only be changed, by special resolution of the Company.
2.5 Meetings of Members
(a) Special and Ordinary resolutions
A special resolution must be passed by a majority of not less than two-thirds (other than
in relation to any resolution approving changes to the Company’s constitutional documents or
a voluntary winding up of the Company, in which case a special resolution must be passed by
a majority of not less than three-fourths) of the voting rights held by such members as, being
entitled so to do, vote in person (whether physically or by virtual attendance with the use of
technology), or by proxy or, in the case of any members which is a corporation, by its duly
authorised representative(s) or by proxy, at a general meeting of which notice specifying the
intention to propose the resolution as a special resolution has been duly given. A special
resolution may also be approved in writing by all the members entitled to vote at a general
meeting in one or more instruments each signed by one or more of such members.
An ordinary resolution, in contrast, is a resolution passed by a simple majority of the
voting rights held by such members as, being entitled to do so, vote in person (whether
physically or by virtual attendance with the use of technology), or by proxy or, in the case of
any member which is a corporation, by its duly authorised representative(s) or by proxy, at a
general meeting. An ordinary resolution may also be approved in writing by all the members
entitled to vote at a general meeting in one or more instruments each signed by one or more
of such members.
The provisions of special resolutions and ordinary resolutions shall apply mutatis
mutandis to any resolutions passed by the holders of any class of shares.
(b) V oting Rights and Right to Demand a Poll
Subject to any rights, restrictions or privileges as to voting for the time being attached to
any class or classes of Shares, at any general meeting: (a) on a poll every member present in
person (whether physically or by virtual attendance with the use of technology), or, in the case
of a member being a corporation, by its duly authorised representative or by proxy shall have
one vote for every Share and (b) on a show of hands every member who is present in person
(whether physically or by virtual attendance with the use of technology), or, in the case of a
member being a corporation, by its duly authorised representative or by proxy shall have one
vote. For the avoidance of doubt, votes may be cast by members by electronic means.
In the case of joint holders, the vote of the senior holder who tenders a vote, whether in
person or by proxy shall be accepted to the exclusion of the votes of the other join holders, and
seniority shall be determined by the order in which the names of the holders stand in the
register of members of the Company.
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No person shall be counted in a quorum or be entitled to vote at any general meeting
unless he is registered as a member on the record date for such meeting, nor unless all calls
or other monies then payable by him in respect of the relevant Shares have been paid.
At any general meeting a resolution put to the vote of the meeting shall be decided by way
of poll save that the chairman of the meeting may, pursuant to the Listing Rules, allow a
resolution which relates purely to a procedural or administrative matter to be voted on by a
show of hands (whether physically or by virtual attendance with the use of technology).
Any corporation or other non-natural person which is a member of the Company may in
accordance with its constitutional documents, or in the absence of such provision by resolution
of its directors or other governing body or by power of attorney, authorise such person as it
thinks fit to act as its representative at any meeting of the Company or of any class of members,
and the person so authorised shall be entitled to exercise the same powers as the corporation
or other non-natural person could exercise as if it were a natural person member of the
Company.
If a recognised clearing house or its nominee(s) is a member of the Company, it may
appoint proxies or authorise such person or persons as it thinks fit to act as its representative(s),
who enjoy rights equivalent to the rights of other members, at any meeting of the Company
(including but not limited to general meetings and creditors meetings) or at any meeting of any
class of members of the Company, provided that if more than one person is so authorised, the
authorisation shall specify the number and class of Shares in respect of which each such person
is so authorised. A person so authorised shall be entitled to exercise the same rights and powers
on behalf of the recognised clearing house or its nominee(s) as if such person were a natural
person member of the Company, including the right to speak and vote individually on a show
of hands or on a poll (whether physically or by virtual attendance with the use of technology).
All members of the Company (including a member which is a recognised clearing house
(or its nominee(s))) shall have the right to (i) speak at a general meeting and (ii) and vote at
a general meeting (whether physically or virtual attendance with the use of technology), except
where a member is required by the Listing Rules to abstain from voting to approve the matter
under consideration. Where any member is, under the Listing Rules, required to abstain from
voting on any particular resolution or restricted to voting only for or only against any particular
resolution, any votes cast by or on behalf of such member in contravention of such requirement
or restriction shall not be counted.
(c) Annual General Meetings and Extraordinary General Meetings
The Company must hold a general meeting as its annual general meeting in each financial
year. Such meeting shall be specified as such in the notices calling it, and must be held within
six months after the end of the Company’s financial year. A meeting of the members or any
class thereof may be held by telephone, tele-conferencing or other electronic means, provided
that all participants can attend the meeting virtually with the use of technology and are able to
communicate contemporaneously with one another, and participation in a meeting in such
manner shall constitute presence at such meetings.
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The Board may convene an extraordinary general meeting whenever it thinks fit. In
addition, one or more members holding, as at the date of deposit of the requisition, in aggregate
not less than one-tenth of the voting rights (on a one vote per Share basis) in the share capital
of the Company may make a requisition to convene an extraordinary general meeting and/or
add resolutions to the agenda of a meeting. Such requisition, which must state the objects and
the resolutions to be added to the agenda of the meeting and must be signed by the
requisitionists, shall be deposited at the principal place of business of the Company in Hong
Kong or, in the event the Company ceases to have such a principal place of business, the
registered office of the Company. If the Board does not within 21 days from the date of deposit
of such requisition duly proceed to convene a general meeting to be held within the following
21 days, the requisitionists or any of them representing more than one-half of the total voting
rights of all the requisitionists may themselves convene a general meeting, but any such
meeting so convened shall be held no later than the day falling three months after the expiration
of the said 21-day period. A general meeting convened by requisitionists shall be convened in
the same manner as nearly as possible as that in which general meetings are to be convened
by the Board, and all reasonable expenses incurred by the requisitionists shall be reimbursed
to the requisitionists by the Company.
(d) Notices of Meetings and Business to be Conducted
An annual general meeting of the Company shall be called by at least 21 days’ notice in
writing, and any other general meeting of the Company shall be called by at least 14 days’
notice in writing. The notice shall be exclusive of the day on which it is served or deemed to
be served and of the day for which it is given, and must specify the date, time, place and agenda
of the meeting, the particulars of the resolution(s) to be considered at the meeting, the general
nature of the business to be considered at the meeting and details for members to attend the
meeting virtually with the use of technology.
Except where otherwise expressly stated, any notice or document (including a share
certificate) to be given or issued under the Articles shall be in writing, and may be served by
the Company on any member personally, by post to such member’s registered address, (to the
extent permitted by the Listing Rules and all applicable laws and regulations) by electronic
means or (in the case of a notice) by advertisement published in the manner prescribed under
the Listing Rules and all applicable laws, rules and regulations, or by sending or otherwise
making it available to the relevant person through such other means, whether electronically or
otherwise, to the extent permitted by and in accordance with the Listing Rules and all
applicable laws, rules and regulations.
Notwithstanding that a meeting of the Company is called by shorter notice than as
specified above, if permitted by the Listing Rules, such meeting may be deemed to have been
duly called if it is so agreed:
(i) in the case of an annual general meeting, by all members of the Company entitled
to attend and vote thereat; and
(ii) in the case of an extraordinary general meeting, by a majority in number of the
members having a right to attend and vote at the meeting holding not less than 95%
of the total voting rights held by such members.
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If, after the notice of a general meeting has been sent but before the meeting is held, or
after the adjournment of a general meeting but before the adjourned meeting is held (whether
or not notice of the adjourned meeting is required), the Board in its absolute discretion consider
that it is impractical or unreasonable for any reason to hold a general meeting on the date or
at the time and place specified in the notice calling such meeting, it may change or postpone
the meeting to another date, time and place.
The Board also has the power to provide in every notice calling a general meeting that
in the event of a gale warning, a black rainstorm warning or extreme conditions is/are in force
at any time on the day of the general meeting (unless such warning is cancelled at least a
minimum period of time prior to the general meeting as the Board may specify in the relevant
notice), the meeting shall be postponed without further notice to be reconvened on a later date.
Where a general meeting is postponed:
(A) the Company shall endeavour to cause a notice of such postponement, which shall
set out the reason for the postponement in accordance with the Listing Rules, to be
placed on the Company’s website and published on the Stock Exchange’s website as
soon as practicable, provided that failure to place or publish such notice shall not
affect the automatic postponement of a general meeting due to a gale warning, a
black rainstorm warning or extreme conditions being in force on the day of the
general meeting;
(B) the Board shall determine the date, time, place and details for members to attend
virtually with the use of technology for the reconvened meeting and at least seven
clear days’ notice shall be given for the reconvened meeting. Such notice shall
specify the date, time and place at which the postponed meeting will be reconvened,
details for members to attend such postponed meeting virtually with the use of
technology and the date and time by which proxies shall be submitted in order to be
valid at such reconvened meeting (provided that any proxy submitted for the original
meeting shall continue to be valid for the reconvened meeting unless revoked or
replaced by a new proxy); and
(C) only the business set out in the notice of the original meeting shall be considered at
the reconvened meeting, and notice given for the reconvened meeting does not need
to specify the business to be considered at the reconvened meeting, nor shall any
accompanying documents be required to be recirculated. Where any new business is
to be considered at such reconvened meeting, the Company shall give a fresh notice
for such reconvened meeting in accordance with the Articles.
(e) Quorum for Meetings and Separate Class Meetings
No business shall be considered at any general meeting unless a quorum is present when
the meeting proceeds to business, and continues to be present until the conclusion of the
meeting.
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The quorum for a general meeting shall be two members present in person (whether
physically or by virtual attendance with the use of technology), or in the case of a member
being a corporation, by its duly authorised representative or by proxy and entitled to vote. In
respect of a separate class meeting (other than an adjourned meeting) convened to approve the
variation of class rights, the necessary quorum shall be two persons holding or representing by
proxy not less than one-third of the issued Shares of that class.
(f) Proxies
Any member of the Company (including a member which is a recognised clearing house
(or its nominee(s))) entitled to attend and vote at a meeting of the Company is entitled to
appoint another person (being a natural person) as his proxy to attend and vote in his place. A
member who is the holder of two or more Shares may appoint more than one proxy to represent
him and vote on his behalf at a general meeting of the Company or at a class meeting. A proxy
need not be a member of the Company and shall be entitled to exercise the same powers on
behalf of a member who is a natural person and for whom he acts as proxy as such member
could exercise. In addition, a proxy shall be entitled to exercise the same powers on behalf of
a member which is a corporation and for which he acts as proxy as such member could exercise
as if it were a natural person member present in person (whether physically or by virtual
attendance with the use of technology) at any general meeting. On a poll or on a show of hands,
votes may be given either personally (or, in the case of a member being a corporation, by its
duly authorised representative) or by proxy.
The instrument appointing a proxy shall be in writing and executed under the hand of the
appointor or of his attorney duly authorised in writing, or if the appointor is a corporation or
other non-natural person, either under its seal or under the hand of a duly authorised
representative.
The Board shall, in the notice convening any meeting or adjourned meeting, or in an
instrument of proxy sent out by the Company, specify the manner by which the instrument
appointing a proxy shall be deposited and the place and time (being no later than the time
appointed for the commencement of the meeting or adjourned meeting to which the instrument
of proxy relates) at which such instrument shall be deposited.
Every instrument of proxy, whether for a specified meeting or otherwise, shall be in such
form that complies with the Listing Rules as the Board may from time to time approve. Any
form issued to a member for appointing a proxy to attend and vote at a general meeting at
which any business is to be considered shall be such as to enable the member, according to his
intentions, to instruct the proxy to vote in favour of or against (or, in default of instructions,
to exercise the discretion of the proxy in respect of) each resolution dealing with any such
business.
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2.6 Accounts and Audit
The Board shall cause to be kept such books of account as are necessary to give a true
and fair view of the state of the Company’s affairs and to explain its transactions in accordance
with the Companies Act.
The books of accounts of the Company shall be kept at the principal place of business of
the Company in Hong Kong or, subject to the provisions of the Companies Act, at such other
place or places as the Board thinks fit and shall always be open to inspection by any Director.
No member (not being a Director) or other person shall have any right to inspect any account,
book or document of the Company except as conferred by the Companies Act or ordered by a
court of competent jurisdiction or as authorised by the Board or the Company in general
meeting.
The Board shall cause to be prepared and laid before the Company at every annual general
meeting a profit and loss account for the period since the preceding account, together with a
balance sheet as at the date to which the profit and loss account is made up, a Directors’ report
with respect to the profit or loss of the Company for the period covered by the profit and loss
account and the state of the Company’s affairs as at the end of such period, an auditors’ report
on such accounts and such other reports and accounts as may be required by law and the Listing
Rules.
The members shall at each annual general meeting appoint auditor(s) to hold office by
ordinary resolution of the members until the conclusion of the next annual general meeting on
such terms and with such duties as may be agreed with the Board. The auditors’ remuneration
shall be fixed by the members at the annual general meeting at which they are appointed by
ordinary resolution of the members or in any other manner as specified in such ordinary
resolution. The members may, at any general meeting convened and held in accordance with
the Articles, remove the auditors by ordinary resolution at any time before the expiration of the
term of office and shall, by ordinary resolution, at that meeting appoint new auditors in their
place for the remainder of the term.
The accounts of the Company shall be prepared and audited based on the generally
accepted accounting principles of Hong Kong, the International Accounting Standards or such
other standards as may be permitted by the Stock Exchange.
2.7 Dividends and other Methods of Distribution
Subject to the Companies Act and the Articles, the Company may by ordinary resolution
resolve to declare dividends and other distributions on Shares in issue in any currency and
authorise payment of the dividends or distributions out of the funds of the Company lawfully
available therefor, provided that (i) no dividends shall exceed the amount recommended by the
Board, and (ii) no dividends or distributions shall be paid except out of the realised or
unrealised profits of the Company, out of the share premium account or as otherwise permitted
by law.
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The Board may from time to time pay to the members of the Company such interim
dividends as appear to the Board to be justified by the financial conditions and the profits of
the Company. In addition, the Board may from time to time declare and pay special dividends
on Shares of such amounts and on such dates as it thinks fit.
Except as otherwise provided by the rights attached to any Shares, all dividends and other
distributions shall be paid according to the amounts paid up on the Shares that a member holds
during the period in respect of which the dividends and distributions are paid. No amount paid
up on a Share in advance of calls shall for this purpose be treated as paid up on the Share.
The Board may deduct from any dividends or other distributions payable to any member
of the Company all sums of money (if any) then payable by him to the Company on account
of calls or otherwise. The Board may retain any dividends or distributions payable on or in
respect of a Share upon which the Company has a lien, and may apply the same in or towards
satisfaction of the debts, liabilities or engagements in respect of which the lien exists.
No dividends or other distributions payable by the Company on or in respect of any Share
shall carry interest against the Company.
Where the Board or the Company in general meeting has resolved that a dividend should
be paid or declared, the Board may further resolve:
(a) that such dividend be satisfied in whole or in part in the form of an allotment of
Shares credited as fully paid on the basis that the Shares so allotted shall be of the
same class as the class already held by the allottee, provided that the members
entitled thereto will be entitled to elect to receive such dividend (or part thereof) in
cash in lieu of such allotment; or
(b) that the members entitled to such dividend will be entitled to elect to receive an
allotment of Shares credited as fully paid in lieu of the whole or such part of the
dividend as the Board may think fit on the basis that the Shares so allotted shall be
of the same class as the class already held by the allottee.
Upon the recommendation of the Board, the Company may by ordinary resolution resolve
in respect of any one particular dividend of the Company determine that notwithstanding the
foregoing, a dividend may be satisfied wholly in the form of an allotment of Shares credited
as fully paid without offering any right to members to elect to receive such dividend in cash
in lieu of such allotment.
Any dividends, distributions or other monies payable in cash in respect of Shares may be
paid by wire transfer to the holder of such Shares or by cheque or warrant sent by post to the
registered address of such holder, or in the case of joint holders, to the registered address of
the holder who is first named on the register of members of the Company, or to such person
and to such address as the holder or joint holders may in writing direct. Any one of two or more
joint holders may give effectual receipts for any dividends, distributions or other monies
payable in respect of the Shares held by them as joint holders.
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Whenever the Board or the Company in general meeting has resolved that a dividend be
paid or declared, the Board may further resolve that such dividend be satisfied in whole or in
part by the distribution of specific assets of any kind.
Any dividends or other distributions which remain unclaimed for six years from the date
on which such dividends or distributions become payable shall be forfeited and shall revert to
the Company.
2.8 Inspection of Corporate Records
For so long as any part of the share capital of the Company is listed on the Stock
Exchange, any member may inspect any register of members of the Company maintained in
Hong Kong (except when the register of members is closed in accordance with the Companies
Ordinance) without charge and require the provision to him of copies or extracts of such
register in all respects as if the Company were incorporated under and were subject to the
Companies Ordinance.
2.9 Rights of Minorities in relation to Fraud or Oppression
There are no provisions in the Articles concerning the rights of minority members in
relation to fraud or oppression. However, certain remedies may be available to members of the
Company under the Cayman Islands laws, as summarised in paragraph 3.6 below.
2.10 Procedures on Liquidation
Subject to the Companies Act, the members of the Company may by special resolution
resolve to wind up the Company voluntarily or by the court.
Subject to any rights, privileges or restrictions as to the distribution of available surplus
assets on liquidation for the time being attached to any class or classes of Shares:
(a) if the assets available for distribution among the members of the Company are more
than sufficient to repay the whole of the Company’s paid up capital at the
commencement of the winding up, the surplus shall be distributed pari passu among
such members in proportion to the amount paid up on the Shares held by them at the
commencement of the winding up; and
(b) if the assets available for distribution among the members of the Company are
insufficient to repay the whole of the Company’s paid up capital, such assets shall
be distributed so that, as nearly as may be, the losses shall be borne by the members
in proportion to the capital paid up, or ought to be paid up, on the Shares held by
them at the commencement of the winding up.
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If the Company is wound up (whether the liquidation is voluntary or compelled by the
court), the liquidator may, with the approval of a special resolution and any other approval
required by the Companies Act, divide among the members in kind the whole or any part of
the assets of the Company, whether the assets consist of property of one kind or different kinds,
and the liquidator may, for such purpose, set such value as he deems fair upon any one or more
class or classes of property to be so divided and may determine how such division shall be
carried out as between the members or different classes of members and the members within
each class. The liquidator may, with the like approval, vest any part of the assets in trustees
upon such trusts for the benefit of the members as the liquidator thinks fit, provided that no
member shall be compelled to accept any shares or other property upon which there is a
liability.
3. COMPANY LA WS OF THE CAYMAN ISLANDS
The Company was incorporated in the Cayman Islands as an exempted company on 3 July
2019 subject to the Companies Act. Certain provisions of the company laws of the Cayman
Islands are set out below but this section does not purport to contain all applicable
qualifications and exceptions or to be a complete review of all matters of the company laws of
the Cayman Islands, which may differ from equivalent provisions in jurisdictions with which
interested parties may be more familiar.
3.1 Company Operations
An exempted company such as the Company must conduct its operations mainly outside
the Cayman Islands. An exempted company is also required to file an annual return each year
with the Registrar of Companies of the Cayman Islands and pay a fee which is based on the
amount of its authorised share capital.
3.2 Share Capital
Under the Companies Act, a Cayman Islands company may issue ordinary, preference or
redeemable shares or any combination thereof. Where a company issues shares at a premium,
whether for cash or otherwise, a sum equal to the aggregate amount or value of the premium
on those shares shall be transferred to an account, to be called the share premium account. At
the option of a company, these provisions may not apply to premium on shares of that company
allotted pursuant to any arrangements in consideration of the acquisition or cancellation of
shares in any other company and issued at a premium. The share premium account may be
applied by the company subject to the provisions, if any, of its memorandum and articles of
association, in such manner as the company may from time to time determine including, but
without limitation, the following:
(a) paying distributions or dividends to members;
(b) paying up unissued shares of the company to be issued to members as fully paid
bonus shares;
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(c) any manner provided in section 37 of the Companies Act;
(d) writing-off the preliminary expenses of the company; and
(e) writing-off the expenses of, or the commission paid or discount allowed on, any
issue of shares or debentures of the company.
Notwithstanding the foregoing, no distribution or dividend may be paid to members out
of the share premium account unless, immediately following the date on which the distribution
or dividend is proposed to be paid, the company will be able to pay its debts as they fall due
in the ordinary course of business.
Subject to confirmation by the court, a company limited by shares or a company limited
by guarantee and having a share capital may, if authorised to do so by its articles of association,
by special resolution reduce its share capital in any way.
3.3 Financial Assistance to Purchase Shares of a Company or its Holding Company
There are no statutory prohibitions in the Cayman Islands on the granting of financial
assistance by a company to another person for the purchase of, or subscription for, its own, its
holding company’s or a subsidiary’s shares. Therefore, a company may provide financial
assistance provided the directors of the company, when proposing to grant such financial
assistance, discharge their duties of care and act in good faith, for a proper purpose and in the
interests of the company. Such assistance should be on an arm’s-length basis.
3.4 Purchase of Shares and Warrants by a Company and its Subsidiaries
A company limited by shares or a company limited by guarantee and having a share
capital may, if so authorised by its articles of association, issue shares which are to be
redeemed or are liable to be redeemed at the option of the company or a member and, for the
avoidance of doubt, it shall be lawful for the rights attaching to any shares to be varied, subject
to the provisions of the company’s articles of association, so as to provide that such shares are
to be or are liable to be so redeemed. In addition, such a company may, if authorised to do so
by its articles of association, purchase its own shares, including any redeemable shares; an
ordinary resolution of the company approving the manner and terms of the purchase will be
required if the articles of association do not authorise the manner and terms of such purchase.
A company may not redeem or purchase its shares unless they are fully paid. Furthermore, a
company may not redeem or purchase any of its shares if, as a result of the redemption or
purchase, there would no longer be any issued shares of the company other than shares held
as treasury shares. In addition, a payment out of capital by a company for the redemption or
purchase of its own shares is not lawful unless, immediately following the date on which the
payment is proposed to be made, the company shall be able to pay its debts as they fall due
in the ordinary course of business.
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Shares that have been purchased or redeemed by a company or surrendered to the
company shall not be treated as cancelled but shall be classified as treasury shares if held in
compliance with the requirements of section 37A(1) of the Companies Act. Any such shares
shall continue to be classified as treasury shares until such shares are either cancelled or
transferred pursuant to the Companies Act.
A Cayman Islands company may be able to purchase its own warrants subject to and in
accordance with the terms and conditions of the relevant warrant instrument or certificate. Thus
there is no requirement under the Cayman Islands laws that a company’s memorandum or
articles of association contain a specific provision enabling such purchases. The directors of a
company may under the general power contained in its memorandum of association be able to
buy, sell and deal in personal property of all kinds.
A subsidiary may hold shares in its holding company and, in certain circumstances, may
acquire such shares.
3.5 Dividends and Distributions
Subject to a solvency test, as prescribed in the Companies Act, and the provisions, if any,
of the company’s memorandum and articles of association, a company may pay dividends and
distributions out of its share premium account. In addition, based upon English case law which
is likely to be persuasive in the Cayman Islands, dividends may be paid out of profits.
For so long as a company holds treasury shares, no dividend may be declared or paid, and
no other distribution (whether in cash or otherwise) of the company’s assets (including any
distribution of assets to members on a winding up) may be made, in respect of a treasury share.
3.6 Protection of Minorities and Shareholders’ Suits
It can be expected that the Cayman Islands courts will ordinarily follow English case law
precedents (particularly the rule in the case of Foss vs. Harbottle and the exceptions to that
rule) which permit a minority member to commence a representative action against or
derivative actions in the name of the company to challenge acts which are ultra vires, illegal,
fraudulent (and performed by those in control of the Company) against the minority, or
represent an irregularity in the passing of a resolution which requires a qualified (or special)
majority which has not been obtained.
Where a company (not being a bank) is one which has a share capital divided into shares,
the court may, on the application of members holding not less than one-fifth of the shares of
the company in issue, appoint an inspector to examine the affairs of the company and, at the
direction of the court, to report on such affairs. In addition, any member of a company may
petition the court, which may make a winding up order if the court is of the opinion that it is
just and equitable that the company should be wound up.
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In general, claims against a company by its members must be based on the general laws
of contract or tort applicable in the Cayman Islands or be based on potential violation of their
individual rights as members as established by a company’s memorandum and articles of
association.
3.7 Disposal of Assets
There are no specific restrictions on the power of directors to dispose of assets of a
company, however, the directors are expected to exercise certain duties of care, diligence and
skill to the standard that a reasonably prudent person would exercise in comparable
circumstances, in addition to fiduciary duties to act in good faith, for proper purpose and in the
best interests of the company under English common law (which the Cayman Islands courts
will ordinarily follow).
3.8 Accounting and Auditing Requirements
A company must cause proper records of accounts to be kept with respect to: (i) all sums
of money received and expended by it; (ii) all sales and purchases of goods by it; and (iii) its
assets and liabilities.
Proper books of account shall not be deemed to be kept if there are not kept such books
as are necessary to give a true and fair view of the state of the company’s affairs and to explain
its transactions.
If a company keeps its books of account at any place other than at its registered office or
any other place within the Cayman Islands, it shall, upon service of an order or notice by the
Tax Information Authority pursuant to the Tax Information Authority Act (2021 Revision) of
the Cayman Islands, make available, in electronic form or any other medium, at its registered
office copies of its books of account, or any part or parts thereof, as are specified in such order
or notice.
3.9 Exchange Control
There are no exchange control regulations or currency restrictions in effect in the Cayman
Islands.
3.10 Taxation
The Cayman Islands currently levy no taxes on individuals or corporations based upon
profits, income, gains or appreciations and there is no taxation in the nature of inheritance tax
or estate duty. There are no other taxes likely to be material to the Company levied by the
Government of the Cayman Islands save for certain stamp duties which may be applicable,
from time to time, on certain instruments.
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3.11 Stamp Duty on Transfers
No stamp duty is payable in the Cayman Islands on transfers of shares of Cayman Islands
companies save for those which hold interests in land in the Cayman Islands.
3.12 Loans to Directors
There is no express provision prohibiting the making of loans by a company to any of its
directors. However, the company’s articles of association may provide for the prohibition of
such loans under specific circumstances.
3.13 Inspection of Corporate Records
The members of a company have no general right to inspect or obtain copies of the
register of members or corporate records of the company. They will, however, have such rights
as may be set out in the company’s articles of association.
3.14 Register of Members
A Cayman Islands exempted company may maintain its principal register of members and
any branch registers in any country or territory, whether within or outside the Cayman Islands,
as the company may determine from time to time. There is no requirement for an exempted
company to make any returns of members to the Registrar of Companies in the Cayman Islands.
The names and addresses of the members are, accordingly, not a matter of public record and
are not available for public inspection. However, an exempted company shall make available
at its registered office, in electronic form or any other medium, such register of members,
including any branch register of member, as may be required of it upon service of an order or
notice by the Tax Information Authority pursuant to the Tax Information Authority Act (2021
Revision) of the Cayman Islands.
3.15 Register of Directors and Officers
Pursuant to the Companies Act, the Company is required to maintain at its registered
office a register of directors, alternate directors and officers. The Registrar of Companies shall
make available the list of the names of the current directors of the Company (and, where
applicable, the current alternate directors of the Company) for inspection by any person upon
payment of a fee by such person. A copy of the register of directors and officers must be filed
with the Registrar of Companies in the Cayman Islands, and any change must be notified to the
Registrar of Companies within 30 days of any change in such directors or officers, including
a change of the name of such directors or officers.
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3.16 Winding up
A Cayman Islands company may be wound up by: (i) an order of the court; (ii) voluntarily
by its members; or (iii) under the supervision of the court.
The court has authority to order winding up in a number of specified circumstances
including where, in the opinion of the court, it is just and equitable that such company be so
wound up.
A voluntary winding up of a company (other than a limited duration company, for which
specific rules apply) occurs where the company resolves by special resolution that it be wound
up voluntarily or where the company in general meeting resolves that it be wound up
voluntarily because it is unable to pay its debt as they fall due. In the case of a voluntary
winding up, the company is obliged to cease to carry on its business from the commencement
of its winding up except so far as it may be beneficial for its winding up. Upon appointment
of a voluntary liquidator, all the powers of the directors cease, except so far as the company
in general meeting or the liquidator sanctions their continuance.
In the case of a members’ voluntary winding up of a company, one or more liquidators
are appointed for the purpose of winding up the affairs of the company and distributing its
assets.
As soon as the affairs of a company are fully wound up, the liquidator must make a report
and an account of the winding up, showing how the winding up has been conducted and the
property of the company disposed of, and call a general meeting of the company for the
purposes of laying before it the account and giving an explanation of that account.
When a resolution has been passed by a company to wind up voluntarily, the liquidator
or any contributory or creditor may apply to the court for an order for the continuation of the
winding up under the supervision of the court, on the grounds that: (i) the company is or is
likely to become insolvent; or (ii) the supervision of the court will facilitate a more effective,
economic or expeditious liquidation of the company in the interests of the contributories and
creditors. A supervision order takes effect for all purposes as if it was an order that the
company be wound up by the court except that a commenced voluntary winding up and the
prior actions of the voluntary liquidator shall be valid and binding upon the company and its
official liquidator.
For the purpose of conducting the proceedings in winding up a company and assisting the
court, one or more persons may be appointed to be called an official liquidator(s). The court
may appoint to such office such person or persons, either provisionally or otherwise, as it
thinks fit, and if more than one person is appointed to such office, the court shall declare
whether any act required or authorised to be done by the official liquidator is to be done by all
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or any one or more of such persons. The court may also determine whether any and what
security is to be given by an official liquidator on his appointment; if no official liquidator is
appointed, or during any vacancy in such office, all the property of the company shall be in the
custody of the court.
3.17 Mergers and Consolidations
The Companies Act permits mergers and consolidations between Cayman Islands
companies and between Cayman Islands companies and non-Cayman Islands companies. For
these purposes, (a) “merger” means the merging of two or more constituent companies and the
vesting of their undertaking, property and liabilities in one of such companies as the surviving
company, and (b) “consolidation” means the combination of two or more constituent
companies into a consolidated company and the vesting of the undertaking, property and
liabilities of such companies to the consolidated company. In order to effect such a merger or
consolidation, the directors of each constituent company must approve a written plan of merger
or consolidation, which must then be authorised by (a) a special resolution of each constituent
company and (b) such other authorisation, if any, as may be specified in such constituent
company’s articles of association. The written plan of merger or consolidation must be filed
with the Registrar of Companies of the Cayman Islands together with a declaration as to the
solvency of the consolidated or surviving company, a list of the assets and liabilities of each
constituent company and an undertaking that a copy of the certificate of merger or
consolidation will be given to the members and creditors of each constituent company and that
notification of the merger or consolidation will be published in the Cayman Islands Gazette.
Dissenting members have the right to be paid the fair value of their shares (which, if not agreed
between the parties, will be determined by the Cayman Islands court) if they follow the
required procedures, subject to certain exceptions. Court approval is not required for a merger
or consolidation which is effected in compliance with these statutory procedures.
3.18 Mergers and Consolidations involving a Foreign Company
Where the merger or consolidation involves a foreign company, the procedure is similar,
save that with respect to the foreign company, the directors of the Cayman Islands exempted
company are required to make a declaration to the effect that, having made due enquiry, they
are of the opinion that the requirements set out below have been met: (i) that the merger or
consolidation is permitted or not prohibited by the constitutional documents of the foreign
company and by the laws of the jurisdiction in which the foreign company is incorporated, and
that those laws and any requirements of those constitutional documents have been or will be
complied with; (ii) that no petition or other similar proceeding has been filed and remains
outstanding or order made or resolution adopted to wind up or liquidate the foreign company
in any jurisdictions; (iii) that no receiver, trustee, administrator or other similar person has
been appointed in any jurisdiction and is acting in respect of the foreign company, its affairs
or its property or any part thereof; (iv) that no scheme, order, compromise or other similar
arrangement has been entered into or made in any jurisdiction whereby the rights of creditors
of the foreign company are and continue to be suspended or restricted.
APPENDIX III SUMMARY OF THE CONSTITUTION OF
OUR COMPANY AND CAYMAN ISLANDS COMPANY LA W
– III-24 –


--- page 662 ---
Where the surviving company is the Cayman Islands exempted company, the directors of
the Cayman Islands exempted company are further required to make a declaration to the effect
that, having made due enquiry, they are of the opinion that the requirements set out below have
been met: (i) that the foreign company is able to pay its debts as they fall due and that the
merger or consolidated is bona fide and not intended to defraud unsecured creditors of the
foreign company; (ii) that in respect of the transfer of any security interest granted by the
foreign company to the surviving or consolidated company (a) consent or approval to the
transfer has been obtained, released or waived; (b) the transfer is permitted by and has been
approved in accordance with the constitutional documents of the foreign company; and (c) the
laws of the jurisdiction of the foreign company with respect to the transfer have been or will
be complied with; (iii) that the foreign company will, upon the merger or consolidation
becoming effective, cease to be incorporated, registered or exist under the laws of the relevant
foreign jurisdiction; and (iv) that there is no other reason why it would be against the public
interest to permit the merger or consolidation.
3.19 Reconstructions and Amalgamations
Reconstructions and amalgamations may be approved by (i) 75% in value of the members
or class of members or (ii) a majority in number representing 75% in value of the creditors or
class of creditors, in each case depending on the circumstances, as are present at a meeting
called for such purpose and thereafter sanctioned by the Grand Court of the Cayman Islands.
Whilst a dissenting member has the right to express to the court his view that the transaction
for which approval is being sought would not provide the members with a fair value for their
shares, it can be expected that the court would approve the transaction if it is satisfied that
(i) the company is not proposing to act illegally or beyond the scope of our corporate authority
and the statutory provisions as to majority vote have been complied with, (ii) the members have
been fairly represented at the meeting in question, (iii) the transaction is such as a businessman
would reasonable approve and (iv) the transaction is not one that would more properly be
sanctioned under some other provisions of the Companies Act or that would amount to a “fraud
on the minority”.
If the transaction is approved, no dissenting member would have any rights comparable
to the appraisal rights (namely the right to receive payment in cash for the judicially
determined value of his shares), which may be available to dissenting members of corporations
in other jurisdictions.
3.20 Takeovers
Where an offer is made by a company for the shares of another company and, within four
months of the offer, the holders of not less than 90% of the shares which are the subject of the
offer accept, the offeror may, at any time within two months after the expiration of that
four-month period, by notice require the dissenting members to transfer their shares on the
terms of the offer. A dissenting member may apply to the Cayman Islands courts within one
month of the notice objecting to the transfer. The burden is on the dissenting member to show
APPENDIX III SUMMARY OF THE CONSTITUTION OF
OUR COMPANY AND CAYMAN ISLANDS COMPANY LA W
– III-25 –


--- page 663 ---
that the court should exercise its discretion, which it will be unlikely to do unless there is
evidence of fraud or bad faith or collusion as between the offeror and the holders of the shares
who have accepted the offer as a means of unfairly forcing out minority members.
3.21 Indemnification
The Cayman Islands laws do not limit the extent to which a company’s articles of
association may provide for indemnification of officers and directors, save to the extent any
such provision may be held by the court to be contrary to public policy, for example, where a
provision purports to provide indemnification against the consequences of committing a crime.
3.22 Economic Substance
The Cayman Islands enacted the International Tax Co-operation (Economic Substance)
Act (2024 Revision) together with the Guidance Notes published by the Cayman Islands Tax
Information Authority from time to time. If a company is considered to be a “relevant entity”
and is conducting one or more of the nine “relevant activities”, then such company will be
required to comply with the economic substance requirements in relation to the relevant
activity from 1 July 2019. All companies whether a relevant entity or not is required to file an
annual report with the Registrar of Companies of the Cayman Islands confirming whether or
not it is carrying on any relevant activities and if it is, it must satisfy an economic substance
test.
4. GENERAL
Harney Westwood & Riegels, the Company’s legal adviser on Cayman Islands laws, has
sent to the Company a letter of advice summarising the aspects of the Companies Act set out
in section 3 above. This letter, together with copies of the Companies Act, the Memorandum
and the Articles, is on display on the websites of the Stock Exchange and the Company as
referred to in the paragraph headed “Documents Delivered to the Registrar of Companies and
Available on Display — Documents Available on Display” in Appendix V . Any person wishing
to have a detailed summary of the Companies Act or advice on the differences between it and
the laws of any jurisdiction with which he is more familiar is recommended to seek
independent legal advice.
APPENDIX III SUMMARY OF THE CONSTITUTION OF
OUR COMPANY AND CAYMAN ISLANDS COMPANY LA W
– III-26 –


--- page 664 ---
A. FURTHER INFORMATION ABOUT OUR COMPANY
1. Incorporation of Our Company
Our Company was incorporated in the Cayman Islands under Cayman Companies Act as
an exempted company with limited liability on July 3, 2019. Our registered office is at the
offices of Harneys Fiduciary (Cayman) Limited located at 4th Floor, Harbour Place, 103 South
Church Street, George Town, P .O. Box 10240, Grand Cayman KY1-1002, Cayman Islands.
Accordingly, our corporate structure and the Memorandum and Articles of Association are
subject to the relevant laws of the Cayman Islands. A summary of certain aspects of the
Cayman Islands company law and a summary of certain provisions of our Memorandum and
Articles of Association are set out in the section headed “Summary of the Constitution of Our
Company and Cayman Islands Company Law” in Appendix III to this prospectus.
Our principal place of business in Hong Kong is at 40/F, Dah Sing Financial Centre, 248
Queen’s Road East, Wanchai, Hong Kong. We have registered as a non-Hong Kong Company
under Part 16 of the Companies Ordinance on September 2, 2024. Ms. TSANG Wing Man, one
of our joint company secretaries, has been appointed as the authorized representative of our
Company for the acceptance of the service of process on behalf of our Company in Hong Kong.
The address for the service of process is the same as our principal place of business in Hong
Kong.
2. Changes in Share Capital of Our Company
Save as disclosed in “History and Corporate Structure — Corporate History —
Establishment and Major Shareholding Changes of Our Company,” there has been no other
alteration in the share capital of our Company during the two years immediately preceding the
date of this prospectus.
3. Changes in the Share Capital of Our Subsidiaries
There has been no other alteration in the registered capital of any of our subsidiaries
within the two years immediately preceding the date of this prospectus. For details of the list
of our subsidiaries, see Note 32 to the Accountant’s Report as set out in Appendix I to this
prospectus.
4. Resolutions of Shareholders of Our Company Passed on April 1, 2025
Written resolutions of our Shareholders were passed on April 1, 2025, pursuant to which,
among others:
(i) all of the Preferred Shares (whether issued or unissued) be re-designated and
reclassified as Shares of US$0.0001 each on a one-for-one basis before the
completion of the Global Offering was approved;
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-1 –


--- page 665 ---
(ii) the Memorandum and Articles of Association was approved and adopted conditional
upon Listing;
(iii) conditional upon all the conditions set out in “Structure of the Global Offering —
Conditions of the Global Offering” being fulfilled:
(a) the Global Offering and the granting of the Offer Size Adjustment Option and
the Over-allotment Option are approved;
(b) the Board (or any of its duly authorized committee or person thereof) was
authorized to allot and issue the new Shares pursuant to the Global Offering
and the Listing;
(c) the Board (or any of its duly authorized committee or person thereof) was
authorized to agree to the Offer Price with the Joint Representatives;
(d) a general unconditional mandate was granted to our Directors to allot, issue
and deal with Shares (including the resale or transfer of Treasury Shares by our
Company) or securities convertible into Shares or options, warrants or similar
rights to subscribe for Shares or such convertible securities and to make or
grant offers, agreements or options (including but not limited to warrants,
bonds, debentures, notes and other securities convertible into Shares) which
would or might require the exercise of such powers, provided that the
aggregate nominal value of Shares allotted or agreed conditionally or
unconditionally to be allotted by our Directors other than pursuant to (A) a
rights issue, (B) any scrip dividend scheme or similar arrangement providing
for the allotment and issuance of Shares in lieu of the whole or part of a
dividend on Shares in accordance with the Articles of Association, (C) the
exercise of any subscription or conversion rights attaching to any warrants or
securities which are convertible into Shares or in issue prior to the date of
passing the relevant resolution or (D) a specific authority granted by the
Shareholders in general meeting, shall not exceed the aggregate of (1) 20% of
the total nominal value of the share capital of our Company in issue (excluding
Treasury Shares, if any) immediately following the completion of and the
Global Offering (assuming the Offer Size Adjustment Option and the Over-
allotment Option are not exercised and the outstanding share options granted
under the Pre-IPO Equity Incentive Plan are not exercised) and (2) the total
nominal value of the share capital of our Company repurchased by our
Company (if any) under the general mandate to repurchase Shares referred to
in paragraph (e) below, such mandate to remain in effect during the period from
the passing of the resolution until the earliest of the conclusion of our next
annual general meeting, the end of the period within which we are required by
any applicable law or the Articles of Association to hold our next annual
general meeting or the date on which the resolution is varied or revoked by an
ordinary resolution of the Shareholders in general meeting (the “ Applicable
Period ”);
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-2 –


--- page 666 ---
(e) a general unconditional mandate was granted to our Directors to exercise all
powers of our Company to repurchase Shares on the Stock Exchange or on any
other stock exchange on which the securities of our Company may be listed and
which is recognized by the SFC and the Stock Exchange for this purpose with
a total nominal value of not more than 10% of the total nominal value of the
share capital of our Company in issue (excluding Treasury Shares, if any)
immediately following completion of the Global Offering (assuming the Offer
Size Adjustment Option and the Over-allotment Option are not exercised and
the outstanding share options granted under the Pre-IPO Equity Incentive Plan
are not exercised), such mandate to remain in effect during the Applicable
Period (the “ Repurchase Mandate ”); and
(f) the general unconditional mandate mentioned in paragraph (d) above be
extended by the addition to the aggregate nominal value of the share capital of
our Company which may be allotted, issued or dealt with or agreed
conditionally or unconditionally to be allotted, issued or dealt with by our
Directors pursuant to such general mandate of an amount representing the
aggregate nominal value of the share capital of our Company repurchased by
our Company pursuant to the mandate to repurchase Shares referred to in
paragraph (e) above, provided that such extended amount shall not exceed 10%
of the aggregate nominal value of our Company’s share capital in issue
(excluding Treasury Shares, if any) immediately following completion of the
Global Offering (assuming the Offer Size Adjustment Option and the Over-
allotment Option are not exercised and the outstanding share options granted
under the Pre-IPO Equity Incentive Plan are not exercised).
5. Restrictions on Repurchase of Our Own Securities
This paragraph contains information required by the Stock Exchange to be included in
this prospectus concerning the repurchase by our Company of our own securities. Our
Directors confirm that neither the explanatory statement of the Share Repurchase Mandate nor
the proposed share repurchase has any unusual features.
(i) Provisions of the Listing Rules
The Listing Rules permit companies with a primary listing on the Stock Exchange to
repurchase their own Shares on the Stock Exchange subject to certain restrictions, the most
important of which are summarized below:
(a) Shareholders’ Approval
All proposed repurchase of securities (which must be fully paid up in the case of
shares) by a company with a primary listing on the Stock Exchange must be approved in
advance by an ordinary resolution of the shareholders, either by way of general mandate
or by specific approval of a particular transaction.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-3 –


--- page 667 ---
Pursuant to a resolution passed by our then Shareholders on April 1, 2025, the
Repurchase Mandate was given to our Directors authorizing any repurchase by our
Company of Shares on the Stock Exchange or on any other stock exchange on which the
securities may be listed and which is recognized by the SFC and the Stock Exchange for
this purpose, of not more than 10% of the aggregate number of our Company’s share
capital in issue (excluding Treasury Shares, if any) immediately following the completion
of the Global Offering (assuming the Offer Size Adjustment Option and the Over-
allotment Option are not exercised and the outstanding share options granted under the
Pre-IPO Equity Incentive Plan are not exercised). For details, see “— A. Further
Information about Our Company — 4. Resolutions of Shareholders of Our Company
Passed on April 1, 2025” in this Appendix.
(b) Source of Funds
Any repurchases of Shares by us must be paid out of funds legally available for the
purpose in accordance with our Articles of Association, the Listing Rules and the Cayman
Companies Act. We are not permitted to repurchase our Shares on the Stock Exchange for
a consideration other than cash or for settlement otherwise than in accordance with the
trading rules of the Stock Exchange from time to time. As a matter of Cayman law, any
purchases by our Company may be made out of profits or out of proceeds of a new issue
of shares made for the purpose of the purchase or from sums standing to the credit of our
share premium account or out of capital, if so authorized by the Articles of Association
and subject to the Cayman Companies Act. Any premium payable on the purchase over
the par value of the shares to be purchased must have been provided for out of profits or
from sums standing to the credit of our share premium account or out of capital, if so
authorized by the Articles of Association and subject to the Cayman Companies Act.
(c) Trading Restrictions
The total number of shares which a listed company may repurchase on the Stock
Exchange is the number of shares representing up to a maximum of 10% of the aggregate
number of shares in issue (excluding treasury shares, if any) immediately after the
completion of its listing. A company may not (A) issue or announce a proposed issue of
new securities, or (B) sell or transfer or announce a proposed sale or transfer of treasury
shares, in compliance with the Listing Rules, for a period of 30 days immediately
following a repurchase without the prior approval of the Stock Exchange. Such restriction
does not apply to (A) a new issue of Shares, or a sale or transfer of treasury shares under
a capitalization issue; (B) a grant of share awards or options under a share scheme that
complies with Chapter 17 of the Listing Rules or a new issue of Shares or a transfer of
treasury shares upon vesting or exercise of shares awards or options under the share
scheme that complies with Chapter 17 of the Listing Rules; and (C) a new issue of Shares
or a transfer of treasury shares pursuant to the exercise of warrants, share options or
similar instruments requiring our Company to issue Shares or transfer treasury shares,
which were outstanding prior to the purchase of its own Shares. In addition, a listed
company is prohibited from repurchasing its shares on the Stock Exchange if the purchase
price is 5% or more than the average closing market price for the five preceding trading
days on which its shares were traded on the Stock Exchange. The Listing Rules also
prohibit a listed company from repurchasing its securities if the repurchase would result
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-4 –


--- page 668 ---
in the number of listed securities which are in the hands of the public falling below the
relevant prescribed minimum percentage as required by the Stock Exchange. A listed
company is required to procure that the broker appointed by it to effect a repurchase of
securities discloses to the Stock Exchange such information with respect to the repurchase
as the Stock Exchange may require.
(d) Status of Repurchased Shares
Pursuant to the Listing Rules, the shares repurchased by an issuer shall be held as
treasury shares or cancelled. The listing of all shares which are held as treasury shares
shall be retained. The issuer shall ensure that treasury shares are appropriately identified
and segregated. The listing of all repurchased securities (whether on the Stock Exchange
or otherwise) but not held as treasury shares is automatically cancelled upon repurchase
and our Company must apply for listing of any further Shares in the normal way. The
relative certificates must be cancelled and destroyed as soon as reasonably practicable
following settlement of any such repurchase. However, the purchase of shares will not be
taken as reducing the amount of the authorized share capital of our Company under the
Cayman Companies Act.
(e) Suspension of Repurchase
A listed company may not make any repurchase of securities at any time after insider
information has come to its knowledge until such information has been made publicly
available. In particular, during the period of 30 days immediately preceding the earlier of
(A) the date of the board meeting (as such date is first notified to the Stock Exchange in
accordance with the Listing Rules) for the approval of a listed company’s results for any
year, half-year, quarterly or any other interim period (whether or not required under the
Listing Rules), and (B) the deadline for publication of an announcement of a listed
company’s results for any year or half-year under the Listing Rules, or quarterly or any
other interim period (whether or not required under the Listing Rules), and ending on the
date of results announcement, the listed company may not repurchase its shares on the
Stock Exchange other than in exceptional circumstances. In addition, the Stock Exchange
may prohibit a repurchase of securities on the Stock Exchange if the Stock Exchange
considers the listed company has breached the Listing Rules.
(f) Reporting Requirements
Certain information relating to repurchases of securities on the Stock Exchange or
otherwise must be reported to the Stock Exchange not later than 30 minutes before the
earlier of the commencement of the morning trading session or any pre-opening session
on the following Business Day following any day on which the listed company may take
a purchase of securities. The report must state the total number of shares purchased the
previous day, the purchase price per share or the highest and lowest prices paid for such
purchases. In addition, a listed company’s annual report is required to disclose details
regarding repurchases of securities made during the year, including a monthly analysis of
the number of securities repurchased, the purchase price per share or the highest and
lowest price paid for all such repurchases, where relevant, and the aggregate prices paid.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-5 –


--- page 669 ---
(g) Core Connected Persons
The Listing Rules prohibit a company from knowingly purchasing securities on the
Stock Exchange from a “core connected person”, that is, a director, chief executive or
substantial shareholder of our Company or any of its subsidiaries or a close associate of
any of them (as defined in the Listing Rules) and a core connected person shall not
knowingly sell his/her/its securities to our Company.
(ii) Reasons for Repurchase
Our Directors believe that it is in the best interest of us and our Shareholders for our
Directors to have general authority from the Shareholders to enable us to repurchase Shares in
the market. Repurchases may, depending on the circumstances, result in an increase in the net
assets and/or earnings per Share. The Directors have sought the grant of a general mandate to
repurchase Shares to give our Company the flexibility to do so if and when appropriate. The
number of Shares to be repurchased on any occasion and the price and other terms upon which
the same are repurchased will be decided by the Directors at the relevant time having regard
to the circumstances then pertaining. Repurchases of Shares will only be made when our
Directors believe that such repurchases will benefit our Company and our Shareholders and our
Company will be able to pay our debts as they fall due in the ordinary course of business.
(iii) Funding of Repurchases
In repurchasing securities, we may only apply funds legally available for such purpose in
accordance with the Memorandum and Articles of Association, the Cayman Companies Act or
other applicable laws of Cayman Islands and the Listing Rules. On the basis of our current
financial condition as disclosed in this prospectus and taking into account our current working
capital position, our Directors consider that, if the Repurchase Mandate were to be exercised
in full, it might have a material adverse effect on our working capital and/or our gearing
position as compared with the position disclosed in this prospectus. However, our Directors do
not propose to exercise the Repurchase Mandate to such an extent as would, in the
circumstances, have a material adverse effect on our working capital requirements or the
gearing levels which in the opinion of our Directors are from time to time appropriate for us.
The exercise in full of the Repurchase Mandate, on the basis of 83,175,764 Shares in issue
(excluding Treasury Shares, if any) immediately following completion of the Global Offering
(assuming the Offer Size Adjustment Option and the Over-allotment Option are not exercised
and the outstanding share options granted under the Pre-IPO Equity Incentive Plan are not
exercised), could accordingly result in up to 8,317,576 Shares being repurchased by our
Company during the period prior to:
(a) the conclusion of the next annual general meeting of our Company;
(b) the expiry of the period within which our Company is required by the Articles of
Association or any applicable law to hold our annual general meeting; or
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-6 –


--- page 670 ---
(c) the variation or revocation by an ordinary resolution of the Shareholders passed in
a general meeting,
whichever is the earliest.
(iv) General
None of our Directors nor, to the best of their knowledge having made all reasonable
enquiries, any of their close associates (as defined in the Listing Rules) currently intends to sell
any Shares to us or our subsidiaries.
Our Directors have undertaken with the Stock Exchange that, so far as the same may be
applicable, they will exercise the Repurchase Mandate in accordance with the Listing Rules,
the Articles of Association, the Cayman Companies Act or any other applicable laws of the
Cayman Islands. Our Company has not repurchased any Shares since our incorporation.
Subject to the applicable requirements under the Listing Rules, our Company may cancel
the repurchased Shares following settlement of any such repurchase or hold them as Treasury
Shares, subject to, for example, market conditions and its capital management needs at the
relevant time of the repurchases.
Should our Company decide to hold repurchased Shares as Treasury Shares, we will, upon
completion of the Share repurchase, withdraw the repurchased Shares from CCASS and
register the Treasury Shares in our Company’s name. We may re-deposit our Treasury Shares
into CCASS only if we have an imminent plan to resell these Treasury Shares on the Stock
Exchange and will complete such resale as soon as possible. We will have appropriate measures
to ensure that it would not exercise any Shareholders’ rights or receive any entitlements which
would otherwise be suspended under the relevant laws with respect to Treasury Shares. These
measures include, for example, an approval by the Board that (i) our Company should procure
its broker not to give any instructions to HKSCC to vote at general meetings for the Treasury
Shares deposited with CCASS; and (ii) in the case of dividends or distributions, our Company
should withdraw the Treasury Shares from CCASS, and either re-register them in our
Company’s name as Treasury Shares or cancel them, in each case before the record date for the
dividends or distributions. Holders of Treasury Shares (if any) shall abstain from voting on
matters that require Shareholders’ approval at our Company’s general meetings.
If, as a result of a repurchase of our Shares pursuant to the Repurchase Mandate, a
Shareholder’s proportionate interest in our voting rights is increased, such increase will be
treated as an acquisition for the purpose of the Takeovers Code. Accordingly, a Shareholder or
a group of Shareholders acting in concert could obtain or consolidate control of us and become
obliged to make a mandatory offer in accordance with Rule 26 of the Takeovers Code. Save as
aforesaid, our Directors are not aware of any consequences which would arise under the
Takeovers Code as a consequence of any repurchases pursuant to the Repurchase Mandate.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-7 –


--- page 671 ---
Any repurchase of Shares which results in the number of Shares held by the public being
reduced to less than 25% of our Shares than in issue could only implemented with the approval
of the Stock Exchange to waive the Listing Rules requirements regarding the public
shareholding referred to above. It is believed that a waiver of this provision would not normally
be given other than in exceptional circumstances.
No core connected person, as defined in the Listing Rules, has notified us that he/she/it
has a present intention to sell Shares to us, or has undertaken not to do so, if the Repurchase
Mandate is exercised.
B. FURTHER INFORMATION ABOUT OUR BUSINESS
1. 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 is or may be material:
(a) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, BIONTECH SE, Morgan Stanley Asia Limited, Jefferies Hong Kong
Limited, CITIC Securities (Hong Kong) Limited, CLSA Limited, China
International Capital Corporation Hong Kong Securities Limited and CMB
International Capital Limited, details of which are set out in the section headed
“Cornerstone Investors” in this prospectus;
(b) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, LA V STAR OPPORTUNITIES LIMITED, Morgan Stanley Asia Limited,
Jefferies Hong Kong Limited, CITIC Securities (Hong Kong) Limited, CLSA
Limited, China International Capital Corporation Hong Kong Securities Limited and
CMB International Capital Limited, details of which are set out in the section
headed “Cornerstone Investors” in this prospectus;
(c) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, LAKE BLEU PRIME HEALTHCARE MASTER FUND LIMITED,
Morgan Stanley Asia Limited, Jefferies Hong Kong Limited, CITIC Securities
(Hong Kong) Limited, CLSA Limited, China International Capital Corporation
Hong Kong Securities Limited and CMB International Capital Limited, details of
which are set out in the section headed “Cornerstone Investors” in this prospectus;
(d) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, LAKE BLEU INNOV A TION HEALTHCARE MASTER FUND
LIMITED, Morgan Stanley Asia Limited, Jefferies Hong Kong Limited, CITIC
Securities (Hong Kong) Limited, CLSA Limited, China International Capital
Corporation Hong Kong Securities Limited and CMB International Capital Limited,
details of which are set out in the section headed “Cornerstone Investors” in this
prospectus;
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-8 –


--- page 672 ---
(e) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, TRUMED HEALTHCARE MASTER FUND, ABS DIRECT EQUITY
FUND LLC ASIA SERIES 11, TRUMED HEALTH INNOV A TION FUND LP ,
Morgan Stanley Asia Limited, Jefferies Hong Kong Limited, CITIC Securities
(Hong Kong) Limited, CLSA Limited, China International Capital Corporation
Hong Kong Securities Limited and CMB International Capital Limited, details of
which are set out in the section headed “Cornerstone Investors” in this prospectus;
(f) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, Fullgoal Fund Management Co., Ltd, Morgan Stanley Asia Limited,
Jefferies Hong Kong Limited, CITIC Securities (Hong Kong) Limited, CLSA
Limited, China International Capital Corporation Hong Kong Securities Limited and
CMB International Capital Limited, details of which are set out in the section
headed “Cornerstone Investors” in this prospectus;
(g) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, FULLGOAL ASSET MANAGEMENT (HK) LIMITED, Morgan Stanley
Asia Limited, Jefferies Hong Kong Limited, CITIC Securities (Hong Kong)
Limited, CLSA Limited, China International Capital Corporation Hong Kong
Securities Limited and CMB International Capital Limited, details of which are set
out in the section headed “Cornerstone Investors” in this prospectus;
(h) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, E FUND MANAGEMENT CO., LTD. (ʮ̡),
Morgan Stanley Asia Limited, Jefferies Hong Kong Limited, CITIC Securities
(Hong Kong) Limited, CLSA Limited, China International Capital Corporation
Hong Kong Securities Limited and CMB International Capital Limited, details of
which are set out in the section headed “Cornerstone Investors” in this prospectus;
(i) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, E FUND MANAGEMENT (HONG KONG) CO., LTD. (˙༺༟ପ၍ଣ
ʮ̡), Morgan Stanley Asia Limited, Jefferies Hong Kong Limited, CITIC
Securities (Hong Kong) Limited, CLSA Limited, China International Capital
Corporation Hong Kong Securities Limited and CMB International Capital Limited,
details of which are set out in the section headed “Cornerstone Investors” in this
prospectus;
(j) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, CHINA UNIVERSAL ASSET MANAGEMENT CO., LTD. (ږ
ʮ̡), Morgan Stanley Asia Limited, Jefferies Hong Kong Limited,
CITIC Securities (Hong Kong) Limited, CLSA Limited, China International Capital
Corporation Hong Kong Securities Limited and CMB International Capital Limited,
details of which are set out in the section headed “Cornerstone Investors” in this
prospectus;
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-9 –


--- page 673 ---
(k) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, PANJING HARBOURVIEW INVESTMENT FUND (ږ,)
Morgan Stanley Asia Limited, Jefferies Hong Kong Limited, CITIC Securities
(Hong Kong) Limited, CLSA Limited, China International Capital Corporation
Hong Kong Securities Limited and CMB International Capital Limited, details of
which are set out in the section headed “Cornerstone Investors” in this prospectus;
(l) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, MY ASIAN OPPORTUNITIES MASTER FUND, L.P ., Morgan Stanley
Asia Limited, Jefferies Hong Kong Limited, CITIC Securities (Hong Kong)
Limited, CLSA Limited, China International Capital Corporation Hong Kong
Securities Limited and CMB International Capital Limited, details of which are set
out in the section headed “Cornerstone Investors” in this prospectus;
(m) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, EMERGING MARKETS HEALTHCARE PARTNERS LLC, Morgan
Stanley Asia Limited, Jefferies Hong Kong Limited, CITIC Securities (Hong Kong)
Limited, CLSA Limited, China International Capital Corporation Hong Kong
Securities Limited and CMB International Capital Limited, details of which are set
out in the section headed “Cornerstone Investors” in this prospectus;
(n) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, WORLDWIDE HEALTHCARE PARTNERS LLC, Morgan Stanley Asia
Limited, Jefferies Hong Kong Limited, CITIC Securities (Hong Kong) Limited,
CLSA Limited, China International Capital Corporation Hong Kong Securities
Limited and CMB International Capital Limited, details of which are set out in the
section headed “Cornerstone Investors” in this prospectus;
(o) the cornerstone investment agreement dated April 3, 2025 entered into among the
Company, SUZHOU SUCHUANG BIOMEDICAL HEALTH VENTURE CAPITAL
FUND PARTNERSHIP (LIMITED PARTNERSHIP) (ᔼᖹɽ਄ੰ௴ุ
ΥྫΆุ(Υྫ)), Morgan Stanley Asia Limited, Jefferies Hong Kong
Limited, CITIC Securities (Hong Kong) Limited, CLSA Limited, China
International Capital Corporation Hong Kong Securities Limited and CMB
International Capital 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-10 –


--- page 674 ---
2. Intellectual Property Rights
(i) Trademarks
(a) Registered Trademarks
As of the Latest Practicable Date, we had registered the following trademarks which
we consider to be or may be material to our business:
No. Trademark Owner Class
Place of
Registration Expiry Date
Registration
Number
1. /H1118/H1118
 Duality
Shanghai
5, 35,
42
Hong Kong July 1, 2034 306599369
2. /H1118/H1118
 Duality
Shanghai
5, 35,
42
Hong Kong July 1, 2034 306599350
3. /H1118/H1118
 Duality
Shanghai
5, 35,
42
Hong Kong July 1, 2034 306599341
4. /H1118/H1118
 Duality
Suzhou
5 PRC June 6, 2034 75776197
5. /H1118/H1118
 Duality
Suzhou
35 PRC June 6, 2034 75779984
6. /H1118/H1118
 Duality
Suzhou
42 PRC June 6, 2034 75776224
7. /H1118/H1118
 Duality
Suzhou
5 PRC June 6, 2034 75772443
8. /H1118/H1118
 Duality
Suzhou
35 PRC June 6, 2034 75762085
9. /H1118/H1118
 Duality
Suzhou
42 PRC June 6, 2034 75759049
10. /H1118
 Duality
Suzhou
5 PRC February 6,
2031
46623566
11. /H1118
 Duality
Suzhou
35 PRC February 6,
2031
46618058
12. /H1118
 Duality
Suzhou
42 PRC January 20,
2031
46614402
13. /H1118
 Duality
Suzhou
5 PRC January 27,
2031
46640026
14. /H1118
 Duality
Suzhou
35 PRC January 20,
2031
46610249
15. /H1118
 Duality
Suzhou
42 PRC January 20,
2031
46612210
16. /H1118
 * Duality
Suzhou
5 PRC February 6,
2035
80146694
* This trademark will be used for DB-1303 in China after its commercialization.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-11 –


--- page 675 ---
(ii) Patents
(a) Registered Patents
As of the Latest Practicable Date, we owned the following registered patents which
we consider to be or may be material to our business:
No. Patent
Type of
patent
Place of
registration Patent number Owner
Expiration
date
Corresponding
drug assets/
technology
platforms
1. Anti-tumor Compound
and Preparation
Method and
Application Thereof
(ʿ
ձᏐ͜)
Invention
patent
PRC CN115925796B Duality
Suzhou
September 28,
2041
DITAC and
DIBAC
platforms
DB-1303;
DB-1419
2. Anti-tumor Compound
and Preparation
Method and
Application Thereof
(ʿ
ձᏐ͜)
Invention
patent
PRC CN116199739B Duality
Suzhou
September 28,
2041
DITAC and
DIBAC
platforms
DB-1305;
DB-1310;
DB-1311
3. Anti-tumor Compound
and Preparation
Method and Use
Thereof
Invention
patent
U.S. US11685742B2 Duality
Suzhou
September 28,
2041
DITAC and
DIBAC
platforms
DB-1303;
DB-1419
4. Anti-tumor Compound
and Preparation
Method and Use
Thereof
Invention
patent
U.S. US11607459B1 Duality
Suzhou
September 28,
2041
DITAC and
DIBAC
platforms
DB-1305;
DB-1310;
DB-1311
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-12 –


--- page 676 ---
(b) Patents under Application
As of the Latest Practicable Date, we have applied for the following PCT patent
applications (which have entered or still have opportunity to enter national phases) which
we consider to be or may be material to our business:
No. Patent
Type of
Patent
Place of
Registration Application Number Applicant
Application
Date
Corresponding
drug assets/
technology
platforms
1. Anti-B7H3 and
PD-L1 Bispecific
Antibody-Drug
Conjugate, Preparation
Method Therefor, and
Use Thereof ( ҤB7H3
ձPD-L1Ҥ
ʿՉႡ௪
ձ͜௄)
Invention
patent
PCT PCT/CN2023/142481 Duality
Shanghai
December 27,
2023
DB-1419
2. Anti-BDCA2 Antibody-
Drug Conjugates and
Uses Thereof ( Ҥ
BDCA2 Ҥ᜗-ਅᑌ
ʿՉ͜௄)
Invention
patent
PCT PCT/CN2023/142457 Duality
Suzhou
December 27,
2023
DB-2304
3. Anti-B7H3 Antibody-
Drug Conjugates and
Uses Thereof ( ҤB7H3
Ҥ᜗-ʿՉ
͜௄)
Invention
patent
PCT PCT/CN2023/098596 Duality
Suzhou
June 6, 2023 DB-1311
4. HER3 Antibody-Drug
Conjugates and Use
Thereof (HER3 Ҥ᜗ᖹ
ʿՉ͜௄)
Invention
patent
PCT PCT/CN2023/073130 Duality
Suzhou
January 19,
2023
DB-1310
5. Steroid Compound and
Conjugate Thereof ( ɓ
ʿՉၢΥ
ي)
Invention
patent
PCT PCT/CN2022/114855 Duality
Suzhou
August 25,
2022
DIMAC
platform;
DB-2304
6. Antitumor Compound,
and Preparation
Method Therefor and
Use Thereof ( ɓ၇Ҥ໕
ج
ձᏐ͜)
Invention
patent
PCT PCT/CN2021/121721 Duality
Suzhou
September 29,
2021
DITAC and
DIBAC
platforms;
DB-1303;
DB-1305;
DB-1310;
DB-1311;
DB-1419
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-13 –


--- page 677 ---
(iii) Domain Name
As of the Latest Practicable Date, we had registered the following internet domain name
which we consider to be or may be material to our business:
No. Domain Name Owner Expiry date
1. /H1118/H1118dualitybiologics.com Duality Shanghai April 20, 2026
Save as aforesaid, as of the Latest Practicable Date, there were no other trade or service
marks, patents, intellectual or industrial property rights which were material in relation to our
Group’s business.
C. FURTHER INFORMATION ABOUT OUR DIRECTORS, CHIEF EXECUTIVE
AND SUBSTANTIAL SHAREHOLDERS
1. Disclosure of Interest
(i) Interests and Short Positions of the Directors and Chief Executive of Our Company in
the Shares, Underlying Shares and Debentures of Our Company and Our Associated
Corporation
The following table sets out the interests and short positions of our Directors and chief
executive of our Company as of the date of this prospectus and immediately following the
completion of the Global Offering (assuming the Offer Size Adjustment Option and the
Over-allotment Option are not exercised and the outstanding share options granted under the
Pre-IPO Equity Incentive Plan are not exercised) 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 (including interests and short positions in which they
are taken or deemed to have under such provisions 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 the Model Code for
Securities Transactions by Directors of Listed Issuers contained in the Listing Rules:
As of the date of this prospectus
Immediately after
the Global Offering (2)
Name
Nature of
interests
Number of
Shares (1)
Approximate
percentage of
interest in our
Company
Number of
Shares (1)
Approximate
percentage of
interest in our
Company
Dr. ZHU
Zhongyuan
(Ⴣ) /H1118/H1118/H1118/H1118/H1118
Interests in
controlled
corporation
(3)
6,500,000 9.54% 6,500,000 7.81%
Beneficial
owner (4)
9,526,123 13.99% 9,526,123 11.45%
Mr. ZHANG
Shaoren
(ੵჭˁ) /H1118/H1118/H1118/H1118/H1118
Beneficial
owner
(5)
592,500 0.87% 592,500 0.71%
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-14 –


--- page 678 ---
As of the date of this prospectus
Immediately after
the Global Offering (2)
Name
Nature of
interests
Number of
Shares (1)
Approximate
percentage of
interest in our
Company
Number of
Shares (1)
Approximate
percentage of
interest in our
Company
Ms. SI Wen
(̡˖) /H1118/H1118/H1118/H1118/H1118/H1118
Beneficial
owner (6)
1,367,959 2.01% 1,367,959 1.64%
Notes:
(1) All interests stated are long positions.
(2) The calculation is based on the total number of 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 and the outstanding share options granted under the Pre-IPO Equity Incentive Plan are not
exercised).
(3) DualityBio Ltd. directly holds 6,500,000 Shares as beneficial owner. As DualityBio Ltd. is wholly
owned by Dr. ZHU Zhongyuan, Dr. ZHU Zhongyuan is deemed to be interested in the Shares held by
DualityBio Ltd. by virtue of the SFO. For details, see the section headed “Substantial Shareholders” in
this prospectus.
(4) These Shares represent Dr. ZHU Zhongyuan’s entitlement to receive up to 9,526,123 Shares pursuant
to the exercise of options granted to him under the Pre-IPO Equity Incentive Plan, subject to the terms
and conditions of these options.
(5) These Shares represent Mr. ZHANG Shaoren’s entitlement to receive up to 592,500 Shares pursuant to
the exercise of options granted to him under the Pre-IPO Equity Incentive Plan, subject to the terms and
conditions of these options.
(6) These Shares represent Ms. SI Wen’s entitlement to receive up to 1,367,959 Shares pursuant to the
exercise of options granted to her under the Pre-IPO Equity Incentive Plan, subject to the terms and
conditions of these options.
(ii) Interests of the Substantial Shareholders in the Shares and Underlying Shares of Our
Company
Save as disclosed in the section headed “Substantial Shareholders,” immediately
following the completion of the Global Offering (assuming the Offer Size Adjustment Option
and the Over-allotment Option are not exercised and the outstanding share options granted
under the Pre-IPO Equity Incentive Plan are not exercised), our Directors are not aware of any
other person (not being a Director or chief executive of our Company) who will have an
interest 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 who is, directly or indirectly, interested in 10% or more of the voting power of
our Company and any other member of our Group.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-15 –


--- page 679 ---
2. Particulars of Directors’ Service Contracts and Letters of Appointment
(i) Executive Directors and Non-executive Directors
We have entered into a service contract with each of our executive Director and our
non-executive Directors in respect of, among other things, (i) compliance of the Listing Rules
and applicable laws; and (ii) observance of the Articles of Association. Such service contracts
have terms of three years commencing from the date of appointment until terminated in
accordance with the terms and conditions of the service contract or by either party giving to
the other party not less than one month’s prior notice in writing.
(ii) Independent non-executive Directors
We have entered into a letter of appointment with each of independent non-executive
Directors in respect of, among other things, (i) compliance of the Listing Rules and applicable
laws; and (ii) observance of the Articles of Association. Such letters of appointment have terms
of either three years commencing from the Listing Date until terminated in accordance with the
terms and conditions of the service contract or by either party giving to the other party not less
than one month’s prior notice in writing.
3. Directors’ Remuneration
For details of the Directors’ remuneration, see “Directors and Senior Management —
Directors’ and Senior Management’s Remuneration” and Note 31 to the Accountant’s Report
as set out in Appendix I to this prospectus.
Save as disclosed above, none of the Directors has or is proposed to have a service
contract with our Company other than contracts expiring or determinable by the employer
within one year without the payment of compensation (other than statutory compensation).
4. Directors’ Competing Interests
None of our Directors are interested in any business apart from our Group’s business
which competes or is likely to compete, directly or indirectly, with the business of our Group.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-16 –


--- page 680 ---
5. Disclaimers
Save as disclosed in this prospectus:
(i) there is no existing or proposed service contract (excluding any contract expiring or
determinable by the employer within one year without payment of compensation
(other than statutory compensation)) between our Directors and any member of our
Group;
(ii) none of our Directors or the experts named in the paragraph headed “— E. Other
Information — 8. Qualifications and Consents of Experts” in this Appendix has any
direct or indirect interest in the promotion of, or in any assets which have been,
within the two years immediately preceding the date of this prospectus, acquired or
disposed of by or leased to any member of our Group, or are proposed to be acquired
or disposed of by or leased to any member of our Group;
(iii) save as in connection with the Underwriting Agreements, none of our Directors nor
any of the experts named in the paragraph headed “— E. Other Information — 8.
Qualifications and Consents of Experts” in this Appendix is materially interested in
any contract or arrangement subsisting at the date of this prospectus which is
significant in relation to the business of our Group as a whole;
(iv) taking no account of any Shares which may be taken up under the Global Offering,
so far as is known to any Director or chief executive of our Company, no other
person (other than a Director or chief executive of our Company) will, immediately
following completion of the Global Offering, have interests or short positions in the
Shares or underlying Shares which would fall to be disclosed to our Company and
the Stock Exchange under the provisions of Divisions 2 and 3 of Part XV of the SFO
or be interested, directly or indirectly, 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 member of our Group;
(v) none of our Directors and the chief executive of our Company has any interests or
short positions in the Shares, underlying Shares or debentures of our Company or its
associated corporations (within the meaning of Part XV of the SFO) which will have
to be notified to our Company and the Stock Exchange pursuant to Divisions 7 and
8 of Part XV of the SFO (including interests and short positions which he is taken
or deemed to have under such provisions of the SFO) or which will be required,
pursuant to section 352 of the SFO, to be entered into the register referred to therein,
or will be required, pursuant to the Model Code for Securities Transactions by
Directors of Listed Issuers as set out in Appendix C3 to the Listing Rules, to be
notified to our Company and the Stock Exchange;
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-17 –


--- page 681 ---
(vi) save in connection with the Underwriting Agreements, none of the experts named in
the paragraph headed “— E. Other Information — 8. Qualifications and Consents of
Experts” in this Appendix: (i) is interested legally or beneficially in any of our
Shares or any shares in any of our subsidiaries; or (ii) has any right (whether legally
enforceable or not) to subscribe for or to nominate persons to subscribe for
securities in any member of our Group; and
(vii) none of our Directors or their respective close associates or any Shareholders of our
Company (who to the knowledge of our Directors owns more than 5% of the number
of our issued shares) has any interest in our five largest suppliers or our five largest
customers.
D. SHARE INCENTIVE PLAN
Pre-IPO Equity Incentive Plan
As of the Latest Practicable Date, we had one share incentive scheme, namely the Pre-IPO
Equity Incentive Plan, the terms of which are not subject to the provisions of Chapter 17 of the
Listing Rules. The Pre-IPO Equity Incentive Plan was adopted on February 28, 2021 and
amended on June 25, 2023.
A summary of the principal terms of the Pre-IPO Equity Incentive Plan is set out below:
(i) Purpose
The purposes of the Pre-IPO Equity Incentive Plan are to secure and retain the services
of the Eligible Individuals (as defined below), provide incentives for such persons to exert
maximum efforts for the success of our Group and provide means by which the Eligible
Individuals (as defined below) may benefit from increases in value of the Shares.
(ii) Eligible Individuals
The following participants (collectively, the “ Eligible Individuals ”) are eligible to
participate in the Pre-IPO Equity Incentive Plan:
Employee /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118any person employed by our Group. However, service solely
as a director or as a member of the board of directors of an
affiliate, or payment of a fee for such services, will not cause
a person to be considered an “Employee” for purposes of the
Pre-IPO Equity Incentive Plan
Director /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118any Director of our Company
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-18 –


--- page 682 ---
Consultant /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118any person, including an advisor, who is (a) engaged by our
Group to render consulting or advisory services and is
compensated for such services, or (b) serving as a member of
the board of directors of any affiliate and is compensated for
such services. However, service solely as a director or as a
member of the board of directors of an affiliate, or payment
of a fee for such service, will not cause a person to be
considered a “consultant” for purposes of the Pre-IPO Equity
Incentive Plan. A consultant will not be eligible for the grant
of share awards under the Pre-IPO Equity Incentive Plan if,
at the time of the grant, either the offer or sale of our
Company’s securities to such consultant is not exempt under
Rule 701 of the U.S. Securities Act (“ Rule 701 ”) because of
the nature of the services that such consultant is providing to
our Company, because the consultant is not a natural person,
or because of any other provision of Rule 701, unless our
Company determines that such grant need not comply with
the requirements of Rule 701 and will satisfy another
exemption under the U.S. Securities Act, and it is in due
compliance with applicable law
(iii) Administration
The Pre-IPO Equity Incentive Plan shall be subject to the administration of the Board or
one or more delegated committees of Directors. All determinations, interpretations and
constructions made by the Board in good faith will not be subject to review by any person and
will be final, binding and conclusive on all persons.
(iv) Types of Awards
The Pre-IPO Equity Incentive Plan permits (a) options, (b) share appreciation rights, (c)
restricted share awards, (d) restricted share unit awards, and (e) other share awards based in
whole or in part by reference to the Shares.
(v) Maximum Number of Shares
The maximum number of Shares that may be issued pursuant to the share awards under
the Pre-IPO Equity Incentive Plan shall not exceed 22,287,582 Shares in the aggregate.
(vi) Grant of Share Awards
Unless determined otherwise by the Board, corporate action constituting a grant by our
Company of a share award to any Eligible Individual will be deemed completed as of the date
of such corporate action, regardless of when the instrument, certificate, or letter evidencing the
share award is communicated to, or received or accepted by, the Eligible Individual.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-19 –


--- page 683 ---
(vii) Exercise of Options and Share Appreciation Rights
(a) Exercise period and conditions
The term of each option or share appreciation right shall be specified in the share
award agreement but shall not exceed ten (10) years from the date of its grant.
To exercise any outstanding share appreciation right, the Eligible Individual must
provide written notice of exercise to our Company in compliance with the provisions of
the share award agreement evidencing such share appreciation right.
(b) Exercise price
The exercise price of each option and share appreciation right granted to a U.S.
Eligible Individual will be not less than 100% of the fair market value of the Shares
subject to the option and share appreciation right on the date of grant, except if such share
award is granted pursuant to an assumption of or substitution for another option or share
appreciation right pursuant to a corporate transaction, and in due compliance with
applicable law. The exercise price of each option and share appreciation right granted to
a non-U.S. Eligible Individual shall be determined by the Board, in compliance with
applicable laws. No option or share appreciation right may be granted with an exercise or
strike price lower than the par value of the Shares.
(c) Early exercise of options
Subject to provisions of the share award agreement, the Eligible Individual may
elect at any time before his or her continuous service terminates to exercise the option as
to any part or all of the Shares subject to the option prior to the full vesting of the option.
(viii) Subscription Price of Options
The amount payable for the Shares to be subscribed for under an option in the event of
the option being exercised may be paid, to the extent permitted by applicable law and as
determined by the Board in its sole discretion, by any combination of the methods of payment,
including, among others, cash, check, bank draft or money order payable to our Company. Any
Shares that are not fully paid will be subject to the forfeiture provisions in the Memorandum
and Articles of Association.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-20 –


--- page 684 ---
(ix) Consideration
Restricted share awards: A restricted share award may be awarded in consideration for (a)
cash, check, bank draft or money order payable to our Company, (b) past services to our
Company or our affiliates, or (c) any other form of legal consideration (including future
services) that may be acceptable to the Board, in its sole discretion, and permissible under
applicable law.
Restricted share unit awards: At the time of grant of a restricted share unit award, the
Board will determine the consideration, if any, to be paid by the Eligible Individual upon
delivery of each Share subject to the restricted share unit award. The consideration to be paid,
if any, by the Eligible Individual for such Share may be paid in any form of legal consideration
that may be acceptable to the Board, in its sole discretion, and permissible under applicable
law.
(x) V esting of Share Awards
Options and share appreciation rights: At the Board’s discretion, the total number of
Shares subject to an option or share appreciation right may vest and become exercisable in
periodic installments that may or may not be equal, the option or share appreciation right may
be subject to such other terms and conditions on the time or times when it may or may not be
exercised, and the vesting provisions of individual options or share appreciation rights may
vary.
Restricted share awards: The Shares awarded under the restricted share award agreement
may be subject to forfeiture to our Company in accordance with a vesting schedule to be
determined by the Board.
Restricted share unit awards: At the date of the grant, the Board may impose restrictions
on or conditions to the vesting of the restricted share unit award as it, in its sole discretion,
deems appropriate.
(xi) Lapse of Share Awards
A share award shall lapse automatically (to the extent not already exercised) immediately
upon the earliest of:
(a) the expiry of the option or share appreciation right period;
(b) the expiry of any of the periods for rights on ceasing employment, disability or
death;
(c) immediately prior to the completion of dissolution or liquidation of our Company;
(d) subject to the Board’s discretion, upon the closing of a corporate transaction;
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-21 –


--- page 685 ---
(e) in the event that the Eligible Individual (i) commits any crime or felony involving
fraud, dishonesty, or moral turpitude under the laws of any applicable jurisdiction,
(ii) attempts to commit, or participate in fraud or an act of dishonesty against our
Company or any of our affiliates, (iii) intentionally and materially violates any
contract or agreement between the Eligible Individual and our Company or any of
our affiliates or of any statutory duty owed to our Company or any of our affiliates,
(iv) commits unauthorized use or disclosure of our Company’s or any of our
affiliates confidential information or trade secrets, (v) commits gross misconduct; or
(f) the date on which the option or share appreciation right is cancelled by the Board.
(xii) Right of Repurchase or Right of First Refusal
The options or share appreciation rights may include a provision, as specified in the share
award agreement, whereby our Company may elect to (a) repurchase all or any part of the
vested Shares acquired by the Eligible Individual, or (b) exercise a right of first refusal
following receipt of notice from the Eligible Individual of the intent to transfer all or any part
of the Shares received, upon the exercise of the options or share appreciation rights. Unless
otherwise provided, the repurchase price for vested Shares shall be the exercise purchase price.
(xiii) Transferability
Options and share appreciation rights: The Board may, in its sole discretion, impose
limitations on the transferability of options and share appreciation rights. In the absence of
such determination by the Board to the contrary, neither an option nor share appreciation right
may be transferred for consideration, except through domestic relations orders or a beneficiary
designation, subject to the approval of the Board or any duly authorized person designated by
our Company and in due compliance with applicable laws.
Restricted share awards: Rights to acquire Shares under the restricted share award
agreement will be transferable by the Eligible Individual only upon such terms and conditions
as are set forth in the agreement, as the Board will determine in its sole discretion, so long as
Shares awarded under the restricted share award agreement remains subject to the terms of the
agreement.
(xiv) Cancellation
The Board, in its sole discretion, with the consent of any affected Eligible Individual, may
effect the cancellation of any outstanding share award and the grant in substitution therefor of
a new consideration.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-22 –


--- page 686 ---
(xv) Clawback Mechanism
If a share award or any portion thereof (i) expires or otherwise terminates without all of
the Shares covered by such share award having been issued or (ii) is settled in cash, such
expiration, termination or settlement will not reduce, or otherwise offset, the number of Shares
that may be available for issuance under the Pre-IPO Equity Incentive Plan.
If any Share issued pursuant to a share award is forfeited back to or repurchased by our
Company because of the failure to meet a contingency or condition required to vest such shares
in the Eligible Individual, the aforementioned Shares will revert to and become available for
issuance under the Pre-IPO Equity Incentive Plan. Any Shares reacquired by our Company in
satisfaction of tax withholding obligations on a share award or as consideration for the exercise
or purchase price of a share award will again become available for issuance under the Pre-IPO
Equity Incentive Plan.
(xvi) Duration, Alteration, Suspension and Termination
The Pre-IPO Equity Incentive Plan shall be valid and effective for the period of ten (10)
years commencing on the adoption date, unless terminated earlier by the Board. Post the
duration, no share award shall be granted pursuant to the Pre-IPO Equity Incentive Plan.
The Board may amend the Pre-IPO Equity Incentive Plan in any respect it deems
necessary or advisable, in due compliance with applicable law. No amendment shall impair an
Eligible Individual’s rights under an outstanding share award unless with the written consent
of such Eligible Individual or as otherwise provided in the Pre-IPO Equity Incentive Plan.
The Board may at any time suspend or terminate the operation of the Pre-IPO Equity
Incentive Plan. Suspension or termination of the Pre-IPO Equity Incentive Plan will not impair
the rights and obligations under any share award granted except with the written consent of the
affected grantee or as otherwise permitted in the Pre-IPO Equity Incentive Plan.
(xvii) Outstanding Options Granted
Since the adoption of the Pre-IPO Equity Incentive Plan, other than options, no other
types of share awards have been awarded by our Company. No further awards will be granted
under the Pre-IPO Equity Incentive Plan upon Listing.
We have conditionally granted all the options under the Pre-IPO Equity Incentive Plan,
being an aggregate of 22,287,582 options (representing the right to subscribe for 22,287,582
Shares) (the “ Outstanding Pre-IPO Options ”) to 139 grantees, who are our current employees
or external consultants, under the Pre-IPO Equity Incentive Plan, all of which will remain
outstanding as of the Listing Date.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-23 –


--- page 687 ---
We are supported by a scientific advisory board of world-renowned ADC experts to guide
our R&D activities and provide invaluable strategic advice. To ensure consistent, high-quality
consulting services and align their interests with the Company’s long-term objectives, we have
granted options to three key external consultants who serve on this board. These options allow
them to subscribe for an aggregate of 300,000 Shares, representing approximately 0.36% of the
total number of Shares in issue immediately after completion of the Global Offering (assuming
the Offer Size Adjustment Option and the Over-allotment Option are not exercised). These
consultants have been engaged for a renewable three-year term to provide expert advice on
R&D activities, strategic developments, and/or regulatory affairs. To the best of our
Company’s knowledge, information and belief having made all reasonable enquiries, save for
Dr. SU Ling, a venture partner of Lilly Asia V entures, none of the external consultants have any
other past or present relationships with our Shareholders, Directors, senior management
members or any of their respective associates.
The number of the Shares underlying the Outstanding Pre-IPO Options amounting to
22,287,582 will only be issued by our Company after the Listing if such Outstanding Pre-IPO
Options are fully vested and exercised. Therefore, the Outstanding Pre-IPO Options will have
potential dilution effect on the Shares held by our Shareholders as of the Listing Date. No
consideration is paid for grant of the Outstanding Pre-IPO Options.
a. As of the Latest Practicable Date, the Shares underlying the Outstanding Pre-IPO Options
(i.e., 22,287,582 Shares) represented approximately 32.73% of the total issued and
outstanding Shares of our Company.
b. The Shares underlying the Outstanding Pre-IPO Options (i.e., 22,287,582 Shares)
represented approximately 26.80% of the total number of Shares in issue immediately
after completion of the Global Offering (assuming the Offer Size Adjustment Option and
the Over-allotment Option are not exercised).
c. The shareholding of our Shareholders upon completion of the Global Offering (assuming
the Offer Size Adjustment Option and the Over-allotment Option are not exercised) will
be diluted by approximately 21.13% if the Outstanding Pre-IPO Options are fully vested
and exercised.
As the Group incurred losses for the year ended December 31, 2024, the dilutive potential
Ordinary Shares were not included in the calculation of diluted loss per Share as their inclusion
would be anti-dilutive. Accordingly, the diluted loss per Share for the year ended December 31,
2024 was the same as the basic loss per Share of the same year.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-24 –


--- page 688 ---
The table below shows the details of options granted to Directors and senior management
of our Company under the Pre-IPO Equity Incentive Plan that are outstanding as of the Latest
Practicable Date:
Name Title Address
Number of
Shares
underlying
the options
granted Date of grant
Exercise
period
Vesting
Period
Exercise
price
Number of
Shares
underlying the
outstanding
options
granted as of
the Latest
Practicable
Date
Approximate
percentage of
issued Shares
immediately
after the
Global
Offering (4)
(US$)
Directors
Dr. ZHU
Zhongyuan
(Ⴣ) /H1118
Chairman of the
Board, executive
Director and
chief executive
officer
Room 403,
Building 10,
Lane 1299,
Dingxiang Road,
Pudong New
Area, Shanghai,
the PRC
903,920 December 20, 2024 Ten (10) years
from date of
grant
Note 3 1.60 903,920 1.09%
451,959 August 10, 2023 Note 1 0.90 451,959 0.54%
2,280,000 June 5, 2023 Note 2 0.90 2,280,000 2.74%
1,140,244 June 10, 2022 Note 1 0.72 1,140,244 1.37%
750,000 January 1, 2022 Note 2 0.30 750,000 0.90%
831,250 December 15, 2021 Note 2 0.30 831,250 1.00%
3,168,750 September 30, 2020 Note 1 0.30 3,168,750 3.81%
Subtotal /H1118/H1118 9,526,123 9,526,123 11.45%
Mr. ZHANG
Shaoren
(ੵჭˁ) /H1118
Executive Director
and vice
president of
finance
Rooms 201-203,
Building 2, Lane
76, Nujiang
Road, Putuo
District,
Shanghai, the
PRC
150,000 February 27, 2025 Ten (10) years
from date of
grant
Note 3 1.60 150,000 0.18%
50,000 February 27, 2025 Note 1 1.60 50,000 0.06%
95,000 January 1, 2024 Note 2 0.90 95,000 0.11%
127,500 April 16, 2021 Note 2 0.72 127,500 0.15%
170,000 November 1, 2020 Note 1 0.30 170,000 0.20%
Subtotal /H1118/H1118 592,500 592,500 0.71%
Ms. SI Wen
(̡˖) /H1118/H1118
Executive Director
and executive
director ( ੂБᐼ
္) of human
resources
Room 402, No. 44,
Lane 438,
Guzong Road,
Pudong New
Area, Shanghai,
the PRC
1,024,159 February 27, 2025 Ten (10) years
from date of
grant
Note 1 1.60 1,024,159 1.23%
10,000 February 27, 2025 Note 3 1.60 10,000 0.12%
50,000 December 29, 2023 Note 1 0.90 50,000 0.06%
23,800 January 1, 2022 Note 2 0.72 23,800 0.03%
170,000 April 20, 2021 Note 1 0.30 170,000 0.20%
Subtotal /H1118/H1118 1,367,959 1,367,959 1.64%
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-25 –


--- page 689 ---
Name Title Address
Number of
Shares
underlying
the options
granted Date of grant
Exercise
period
Vesting
Period
Exercise
price
Number of
Shares
underlying the
outstanding
options
granted as of
the Latest
Practicable
Date
Approximate
percentage of
issued Shares
immediately
after the
Global
Offering (4)
(US$)
Senior management members
Dr. QIU
Y ang
(เ) /H1118/H1118
Chief scientific
officer
74 Alder Lane,
Basking Ridge,
NJ 07920, the
United States
300,000 March 3, 2025 Ten (10) years
from date of
grant
Note 1 1.60 300,000 0.36%
240,000 December 29, 2023 Note 1 0.90 240,000 0.29%
500,000 November 1, 2023 Note 1 0.90 500,000 0.60%
500,000 July 1, 2023 Note 1 0.90 500,000 0.60%
280,000 July 1, 2023 Note 2 0.90 280,000 0.34%
562,500 July 19, 2021 Note 1 0.72 562,500 0.68%
Subtotal /H1118/H1118 2,382,500 2,382,500 2.86%
Ms. GU Wei
(ᚥᑢ) /H1118/H1118
Chief medical
officer
6D, No. 3, Lane
888, South
Shaanxi Road,
Xuhui District,
Shanghai, the
PRC
1,000,000 July 18, 2022 Ten (10) years
from date of
grant
Note 1 0.72 1,000,000 1.20%
Mr. W ANG
Xin
(׿)H1118/H1118
Chief business
officer
16 Jersey Avenue,
Edison, NJ
08820, the
United States
150,000 March 3, 2025 Ten (10) years
from date of
grant
Note 1 1.60 150,000 0.18%
375,000 December 27, 2022 Note 1 0.90 375,000 0.45%
Subtotal /H1118/H1118 525,000 525,000 0.63%
Dr. HUA
Haiqing
(ऎ૶) /H1118
Senior vice
president and
head of drug
discovery
Room 601, No. 6,
Lane 498, Bohua
Road, Pudong
New Area,
Shanghai, the
PRC
100,000 March 3, 2025 Ten (10) years
from date of
grant
Note 1 1.60 100,000 0.12%
100,000 March 3, 2025 Note 3 1.60 100,000 0.12%
112,500 January 1, 2024 Note 2 0.90 112,500 0.14%
375,000 January 1, 2022 Note 1 0.72 375,000 0.45%
Subtotal /H1118/H1118 687,500 687,500 0.83%
Mr. YU Xin
(ɲ㒥) /H1118/H1118
Vice president and
head of
regulatory affairs
Room 203,
Building 6,
Guang’an Men
Wai Street,
Xicheng District,
Beijing, the PRC
15,000 March 3, 2025 Ten (10) years
from date of
grant
Note 3 1.60 15,000 0.18%
80,000 January 1, 2024 Note 2 0.90 80,000 0.10%
187,500 January 1, 2022 Note 1 0.72 187,500 0.23%
Subtotal /H1118/H1118 417,500 417,500 0.50%
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-26 –


--- page 690 ---
Name Title Address
Number of
Shares
underlying
the options
granted Date of grant
Exercise
period
Vesting
Period
Exercise
price
Number of
Shares
underlying the
outstanding
options
granted as of
the Latest
Practicable
Date
Approximate
percentage of
issued Shares
immediately
after the
Global
Offering (4)
(US$)
Dr. SHI
Rong
(࿰) /H1118/H1118
Vice president of
development
science
422 Wendover Dr,
Princeton, NJ
08540, the
United States
187,500 August 24, 2022 Ten (10) years
from date of
grant
Note 1 0.72 187,500 0.23%
Dr. CHU
Ruiyin
(Ꮇ๿ვ) /H1118
Vice president of
translational
medicine
8 Comstock Lane,
Skillman,
NJ08558, the
United States
180,000 January 24, 2024 Ten (10) years
from date of
grant
Note 1 0.90 180,000 0.22%
Ms. ZHOU
Lan
(մళ) /H1118/H1118
Vice president of
commercial
strategy
Room 1002,
7 Lane 1398,
Gubei Road,
Changning
District,
Shanghai,
the PRC
20,000 March 3, 2025 Ten (10) years
from date of
grant
Note 1 1.60 20,000 0.02%
60,000 November 1, 2024 Note 1 0.90 60,000 0.07%
Subtotal /H1118/H1118 80,000 80,000 0.10%
Total /H1118/H1118/H1118 16,946,582 16,946,582 20.37%
The table below shows the details of options granted to external consultants under the
Pre-IPO Equity Incentive Plan that are outstanding as of the Latest Practicable Date:
Name Address
Number
of Shares
underlying
the options
granted Date of grant
Exercise
period
Vesting
Period
Exercise
price
Number of
Shares
underlying the
outstanding
options
granted as of
the Latest
Practicable
Date
Approximate
percentage of
issued Shares
immediately
after the
Global
Offering (4)
(US$)
Antoine Y ver /H1118/H1118/H1118/H111842 Washington St
Rocky Hill, NJ
08553, the United
States
200,000 June 1, 2022 Ten (10) years
from date of
grant
Note 2 0.72 200,000 0.24%
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-27 –


--- page 691 ---
Name Address
Number
of Shares
underlying
the options
granted Date of grant
Exercise
period
Vesting
Period
Exercise
price
Number of
Shares
underlying the
outstanding
options
granted as of
the Latest
Practicable
Date
Approximate
percentage of
issued Shares
immediately
after the
Global
Offering (4)
(US$)
Pasi A. Janne /H1118/H1118/H11189 Savoy Road,
Needham,
MA 02492,
the United States
50,000 November 1,
2022
Ten (10) years
from date of
grant
Note 2 0.90 50,000 0.06%
SU Ling /H1118/H1118/H1118/H1118/H1118/H1118Room 502, No. 477,
Y ongjia Road,
Xuhui District,
Shanghai, the
PRC
50,000 April 22, 2024 Ten (10) years
from date of
grant
Note 2 0.90 50,000 0.06%
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118 300,000 300,000 0.36%
The table below shows the details of the options granted to non-connected employees of
our Group (who are not Directors or senior management) to subscribe for 60,000 Shares or
above that are outstanding as of the Latest Practicable Date.
Name Position Address
Number
of Shares
underlying
the options
granted Date of grant Exercise period Vesting Period
Exercise
price
Number of
Shares
underlying the
outstanding
options granted
as of the Latest
Practicable Date
Approximate
percentage of
issued Shares
immediately
after the Global
Offering
(US$)
ZHANG Y u /H1118/H1118Executive
director
Room 604, Building
16, Tianyuejunting,
Lane 438, Ruihong
Road, Hongkou
District, Shanghai,
the PRC
316,000 January 13, 2021 –
March 3, 2025
Ten (10) years
from date of
grant
Note 1, Note 2,
Note 3
0.30–1.60 316,000 0.38%
W ANG Y ue /H1118/H1118VP of
investor
relations
Room 301, Building
4, Gree Plaza, No.
2123, Middle
Jiuzhou Avenue,
Xiangzhou District,
Zhuhai, Guangdong
Province, the PRC
200,000 March 3, 2025 Ten (10) years
from date of
grant
Note 1 1.60 200,000 0.24%
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-28 –


--- page 692 ---
Name Position Address
Number
of Shares
underlying
the options
granted Date of grant Exercise period Vesting Period
Exercise
price
Number of
Shares
underlying the
outstanding
options granted
as of the Latest
Practicable Date
Approximate
percentage of
issued Shares
immediately
after the Global
Offering
(US$)
LIU Liming /H1118/H1118Executive
medical
director
4611 Dickinson Way
Doylestown, PA,
18902, the United
States
170,000 May 15, 2022 Ten (10) years
from date of
grant
Note 1 0.72 170,000 0.20%
LI Xi /H1118/H1118/H1118/H1118/H1118Executive
director of
immunology
Room 601A, No. 12,
Lane 881, Laiyang
Road, Pudong New
District, Shanghai,
the PRC
150,000 November 24,
2021
Ten (10) years
from date of
grant
Note 1 0.72 150,000 0.18%
LIU Shengxue /H1118Senior
director of
biometrics
Room 6-1-602,
Langxuan, Jindu
September Villa,
Xiuyuan Road,
Xiuzhou District,
Jiaxing, Zhejiang
Province, the PRC
150,000 January 1, 2023 Ten (10) years
from date of
grant
Note 1 0.72 150,000 0.18%
YUAN Jiali /H1118/H1118Executive
director,
legal
Room 102, No. 34,
Lane 34, Xueye
Road, Pudong New
District, Shanghai,
the PRC
130,000 February 1, 2024;
March 3, 2025
Ten (10) years
from date of
grant
Note 1 0.90;1.60 130,000 0.16%
SHENG Kuan /H1118Executive
medical
director
59 Erica Way,
Parsippany, NJ,
07054, the United
States
100,000 February 12, 2025 Ten (10) years
from date of
grant
Note 1 0.90 100,000 0.12%
HU Lili /H1118/H1118/H1118/H1118VP of clinical
operation
Room 703, Unit 5,
Building 10,
Moliyuan,
Chaoyang District,
Beijing, the PRC
100,000 December 24,
2024; March 3,
2025
Ten (10) years
from date of
grant
Note 1 0.90;1.60 100,000 0.12%
HUANG Zheng /H1118Project
portfolio
management,
executive
director
6A, No. 16, Lane
688, West Y an’an
Road, Shanghai,
the PRC
100,000 May 6, 2024;
March 3, 2025
Ten (10) years
from date of
grant
Note 1 0.90;1.60 100,000 0.12%
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-29 –


--- page 693 ---
Name Position Address
Number
of Shares
underlying
the options
granted Date of grant Exercise period Vesting Period
Exercise
price
Number of
Shares
underlying the
outstanding
options granted
as of the Latest
Practicable Date
Approximate
percentage of
issued Shares
immediately
after the Global
Offering
(US$)
LI Chenggang /H1118Project
leader,
director
102, No. 32, Lane
299, Yijiang Road,
Pudong New
District, Shanghai,
the PRC
100,000 June 13, 2022 Ten (10) years
from date of
grant
Note 1 0.72 100,000 0.12%
LIU Jing /H1118/H1118/H1118Executive
director –
business
development
Room 1602, Building
15, Lane 801,
Yinghua Road,
Pudong New
District, Shanghai,
the PRC
100,000 July 3, 2023 Ten (10) years
from date of
grant
Note 1 0.90 100,000 0.12%
TANG Lili /H1118/H1118/H1118Biomarker
investigator,
director
6C, Building 1, Lane
628, Zhangyang
Road, Pudong New
District, Shanghai,
the PRC
100,000 August 21, 2022 Ten (10) years
from date of
grant
Note 1 0.72 100,000 0.12%
Y AO Jun /H1118/H1118/H1118Director of
preclinical
development
302, Building 10,
Lane 180, Liangxiu
Road, Zhangjiang
Hi-Tech Park,
Pudong New
District, Shanghai,
the PRC
100,000 August 17, 2022 Ten (10) years
from date of
grant
Note 1 0.72 100,000 0.12%
YI Lei /H1118/H1118/H1118/H1118Medicinal
chemistry,
director
Phase 1, Tianfu Yijia,
Damian
Subdistrict,
Longquanyi
District, Chengdu,
Sichuan Province,
the PRC
100,000 October 28, 2022 Ten (10) years
from date of
grant
Note 1 0.72 100,000 0.12%
ZHOU Y unhua /H1118Project
leader,
director
Room 201, Building
19, Lane 32,
Zhoutai Road,
Pudong New
District, Shanghai,
the PRC
100,000 June 6, 2022 Ten (10) years
from date of
grant
Note 1 0.72 100,000 0.12%
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-30 –


--- page 694 ---
Name Position Address
Number
of Shares
underlying
the options
granted Date of grant Exercise period Vesting Period
Exercise
price
Number of
Shares
underlying the
outstanding
options granted
as of the Latest
Practicable Date
Approximate
percentage of
issued Shares
immediately
after the Global
Offering
(US$)
CHEN Y ujian /H1118/H1118Clinical trial
project
management,
executive
director
482 Panchita Way,
Los Altos, CA,
94022, the United
States
80,000 December 6, 2022 Ten (10) years
from date of
grant
Note 1 0.72 80,000 0.10%
MEI Jiajun /H1118/H1118/H1118RA director 2022 W Main St, A,
Houston, TX,
77098, the United
States
80,000 February 21, 2024;
March 3, 2025
Ten (10) years
from date of
grant
Note 1 0.90;1.60 80,000 0.10%
QIU Peiran /H1118/H1118CMC project
management,
director
202, No. 5, Lane
337, Lianzhong
Road, Pudong New
District, Shanghai,
the PRC
80,000 December 28, 2023 Ten (10) years
from date of
grant
Note 1 0.90 80,000 0.10%
ZHENG Xuan /H1118Senior QA
director
Room 101, No. 54,
Lane 518, Gongfu
Road, Baoshan
District, Shanghai,
the PRC
80,000 October 24, 2023 Ten (10) years
from date of
grant
Note 1 0.90 80,000 0.10%
LI Xi /H1118/H1118/H1118/H1118/H1118Clinical data
management,
senior
director
46-701, No. 998,
Huangjiahuayuan
Road, Jiading
District, Shanghai,
the PRC
60,000 November 9, 2022;
March 3, 2025
Ten (10) years
from date of
grant
Note 1 0.72;1.60 60,000 0.07%
LI Bing /H1118/H1118/H1118/H1118Associate
director –
medical
chemistry
No. 19, Lane 930,
Bohua Road,
Pudong New
District, Shanghai,
the PRC
60,000 January 1, 2022;
March 3, 2025
Ten (10) years
from date of
grant
Note 1 0.72;1.60 60,000 0.07%
QU Chen /H1118/H1118/H1118CMC project
leader -
CMC
project
management,
director
Room 1702, No. 50,
Lane 289, Jinhe
Road, Pudong New
District, Shanghai,
the PRC
60,000 July 17, 2022;
March 3, 2025
Ten (10) years
from date of
grant
Note 1 0.72;1.60 60,000 0.07%
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-31 –


--- page 695 ---
Name Position Address
Number
of Shares
underlying
the options
granted Date of grant Exercise period Vesting Period
Exercise
price
Number of
Shares
underlying the
outstanding
options granted
as of the Latest
Practicable Date
Approximate
percentage of
issued Shares
immediately
after the Global
Offering
(US$)
SUN Xiaodong /H1118Senior
medical
director
Room 402, Building
5, No. 2880,
Chuanzhou
Highway,
Shanghai, the PRC
60,000 May 29, 2024;
March 3, 2025
Ten (10) years
from date of
grant
Note 1 0.90;1.60 60,000 0.07%
ZHANG Lijuan /H1118Medical
writing,
director
Room 303, Unit 1,
Lane 2777, Langgu
Road, Pudong New
District, Shanghai,
the PRC
60,000 October 15, 2022;
March 3, 2025
Ten (10) years
from date of
grant
Note 1 0.72;1.60 60,000 0.07%
ZHANG
Y uanyuan /H1118/H1118
IP , associate
director
Room 202, No. 22,
Lane 169,
Zhoukang Road,
Zhoupu Town,
Pudong New
District, Shanghai,
the PRC
60,000 June 27, 2022;
March 3, 2025
Ten (10) years
from date of
grant
Note 1 0.72;1.60 60,000 0.07%
Total /H1118/H1118/H1118/H1118/H1118 2,696,000 2,696,000 3.24%
The table below sets out the details of the share options granted to other grantees that are
not set out above under the Pre-IPO Equity Incentive Plan as of the Latest Practicable Date:
Range of Shares
underlying the
options granted
Total number
of grantees Date of grant Exercise Period Vesting Period Exercise price
Number of
Shares
underlying the
outstanding
options as of
the Latest
Practicable
Date
Approximate
percentage of
issued Shares
immediately
after the
Global
Offering
(4)
(US$)
30,001 – 59,999 /H1118/H1118 19 January 1, 2022 –
March 3, 2025
Ten (10) years from
date of grant
Note 1 0.72 – 1.60 885,000 1.06%
10,001 – 30,000 /H1118/H1118 55 February 4, 2022 –
March 10, 2025
Ten (10) years from
date of grant
Note 1 0.72 – 1.60 1,225,000 1.47%
1 – 10,000 /H1118/H1118/H1118/H1118 26 October 19, 2022 –
March 3, 2025
Ten (10) years from
date of grant
Note 1 0.72 – 1.60 235,000 0.28%
Total /H1118/H1118/H1118/H1118/H1118/H1118/H1118100 2,345,000 2.82%
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-32 –


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Notes:
(1) 25% of the options granted to such grantee will be vested at the first-year anniversary of the date of grant, the
remaining will be vested during the three years thereafter, with 1/48 of the total number of options vested each
month.
(2) 33% of the options granted to such grantee will be vested during the first year from the date of grant, 33% will
be vested during the second year and the remaining 34% will be vested during the third year.
(3) 1/3 of the options granted to such grantee will be vested on the date of completion of applicable milestones
(the “ Milestone Options Vesting Date ”), 1/3 will be vested on the first anniversary of the Milestone Options
V esting Date and the remaining 1/3 will be vested on the second anniversary of the Milestone Options V esting
Date.
(4) Assuming the Offer Size Adjustment Option and the Over-allotment Option are not exercised.
We have applied for, and have been granted (i) a waiver from the Stock Exchange from
strict compliance with the requirements under Rule 17.02(1)(b) of the Listing Rules and
paragraph 27 of Appendix D1A to the Listing Rules; and (ii) a certificate of exemption from
the SFC from strict compliance with paragraph 10(d) of Part I of the Third Schedule to the
Companies (Winding Up and Miscellaneous Provisions) Ordinance pursuant to section 342A
of the Companies (Winding Up and Miscellaneous Provisions) Ordinance. For details, see
“Waivers from Strict Compliance with the Listing Rules and Exemptions from the Companies
(Winding Up and Miscellaneous Provisions) Ordinance” in this prospectus.
E. OTHER INFORMATION
1. Estate Duty
Our Directors have been advised that no material liability for estate duty is likely to
impose on our Company or any of the subsidiaries of our Company.
2. Litigation
As of the Latest Practicable Date, no member of our Group was involved in any litigation,
arbitration, administrative proceedings or claims of material importance, and, so far as we are
aware, no litigation, arbitration, administrative proceedings or claims of material importance
are pending or threatened against any member of our Group.
3. Joint Sponsors
The Joint Sponsors satisfy the independence criteria applicable to sponsors set out in Rule
3A.07 of the Listing Rules. Each of the Joint Sponsors will receive a fee of US$500,000 to act
as a sponsor to our Company in connection with the Global Offering. The Joint Sponsors have
made an application on our Company’s behalf to the Listing Committee of the Stock Exchange
for the granting of the approval for the listing of, and permission to deal in, all the Shares in
issue and to be issued as mentioned in this prospectus. All necessary arrangements have been
made for the Shares to be admitted into CCASS.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-33 –


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4. Preliminary Expenses
As of the Latest Practicable Date, our Company has not incurred any material preliminary
expenses.
5. No Material Adverse Change
Our Directors confirm that there has been no material adverse change in the financial or
trading position or prospects of our Group since December 31, 2024 (being the date to which
the latest audited historical financial information of our Group were prepared).
6. Promoters
Our Company has no promoter for the purpose of the Listing. Within the two years
immediately preceding the date of this prospectus, no cash, securities or other benefit has been
paid, allotted or given nor are any proposed to be paid, allotted or given to any promoters in
connection with the Global Offering and the related transactions described in this prospectus.
7. Agency Fees or Commissions Received
Save as disclosed in the section headed “Underwriting — Underwriting Arrangements and
Expenses” in this prospectus, within the two years immediately preceding the date of this
prospectus, no commissions, discounts, brokerages or other special terms have been granted in
connection with the issue or sale of any share or loan capital of our Company or any of our
subsidiaries.Within the two years preceding the date of this prospectus, no commission has
been paid or is payable for subscribing or agreeing to subscribe, or procuring or agreeing to
procure the subscriptions, for any Shares in our Company.
8. Qualifications and Consents of Experts
The following are the qualifications of the experts who have given opinions or advice
which are contained in this prospectus:
Name Qualification
Morgan Stanley Asia Limited /H1118/H1118A licensed corporation to conduct Type 1 (dealing
in securities), Type 4 (advising on securities),
Type 5 (advising on futures contracts), Type 6
(advising on corporate finance) and Type 9 (asset
management) regulated activities under the SFO
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-34 –


--- page 698 ---
Name Qualification
Jefferies Hong Kong Limited* /H1118A licensed corporation to conduct Type 1 (dealing
in securities), Type 4 (advising on securities) and
Type 6 (advising on corporate finance) regulated
activities under the SFO
CITIC Securities (Hong Kong)
Limited* /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118
a licensed corporation to conduct Type 4 (advising
on securities) and Type 6 (advising on corporate
finance) regulated activities under the SFO
CM Law Firm /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Legal advisors to our Company as to PRC laws
JunHe LLP /H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118/H1118Legal advisors to our Company as to PRC
intellectual property laws
Jun He Law Offices P .C. /H1118/H1118/H1118/H1118/H1118Legal advisors to our Company as to intellectual
property laws of the United States
Harney Westwood & Riegels /H1118/H1118/H1118Legal advisors to our Company as to Cayman
Islands laws
PricewaterhouseCoopers /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
Independent industry consultant
(* in no particular order)
Each of the experts named above has given and has not withdrawn its consent to the issue
of this prospectus with the inclusion of its report, letter, summary of valuations, valuation
certificates and/or legal opinion (as the case may be) and references to its name included in the
form and context in which it respectively appears.
None of the experts named above has any shareholding interests 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 our Company or any of our subsidiaries.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-35 –


--- page 699 ---
9. Binding Effect
This prospectus shall have the effect, if any application is made pursuant hereto, of
rendering all persons concerned bound by all 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.
10. Bilingual Prospectus
The English language and Chinese language versions of this prospectus are being
published separately, in reliance upon the exemption provided by section 4 of the Companies
Ordinance (Exemption of Companies and Prospectuses from Compliance with Provisions)
Notice (Chapter 32L of the Laws of Hong Kong). In case of any discrepancies between the
English language version and Chinese language version of this prospectus, the English
language version shall prevail.
11. Miscellaneous
(i) Save as disclosed in “History and Corporate Structure” and in connection with the
Underwriting Agreements, within the two years immediately preceding the date of
this prospectus:
(a) no share or loan capital of our Company or any of its subsidiaries has been
issued nor agreed to be issued fully or partly paid either for cash or for a
consideration other than cash;
(b) no commissions, discounts, brokerage fee or other special terms have been
granted in connection with the issue or sale of any Share or loan capital of our
Company or any of our subsidiaries;
(c) no Share or loan capital of our Company is under option or is agreed
conditionally or unconditionally to be put under option; and
(d) no commission has been paid or is payable for subscribing or agreeing to
subscribe, or procuring or agreeing to procure the subscriptions of any share in
our Company or any of our subsidiaries;
(ii) we have not issued nor agreed to issue any founder shares, management shares or
deferred shares;
(iii) there are no arrangements under which future dividends are waived or agreed to be
waived;
(iv) 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-36 –


--- page 700 ---
(v) 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;
(vi) there are no restrictions affecting the remittance of profits or repatriation of capital
by us into Hong Kong from outside Hong Kong;
(vii) 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; and
(viii) our Company has no outstanding convertible debt securities or debentures.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-37 –


--- page 701 ---
DOCUMENTS DELIVERED TO THE REGISTRAR OF COMPANIES IN HONG KONG
The documents attached to the copy of this prospectus and delivered to the Registrar of
Companies in Hong Kong for registration were, among other documents:
(a) the written consents referred to in “Appendix IV — Statutory and General
Information — E. Other Information — 8. Qualifications and Consents of Experts;”
and
(b) copies of the material contracts referred to in “Appendix IV — Statutory and
General Information — B. Further Information about Our Business — 1. Summary
of Material Contracts.”
DOCUMENTS A V AILABLE ON DISPLAY
Copies of the following documents will be available on display on the Stock Exchange’s
website at www.hkexnews.hk and our Company’s website at www.dualitybiologics.com
during a period of 14 days from the date of this prospectus:
(a) the Memorandum of Association and Articles of Association;
(b) the Accountant’s Report for the two years ended December 31, 2023 and 2024 from
PricewaterhouseCoopers, the text of which is set out in Appendix I to this
prospectus;
(c) the audited historical financial information of our Group for the two years ended
December 31, 2023 and 2024;
(d) the report on unaudited pro forma financial information of our Group from
PricewaterhouseCoopers, the text of which is set out in Appendix II to this
prospectus;
(e) the legal opinions issued by CM Law Firm, our PRC Legal Advisor in respect of
general matters and property interests of our Group in the PRC;
(f) the legal opinions issued by JunHe LLP and Jun He Law Offices P .C., our legal
advisors as to PRC and United States intellectual property laws, respectively, in
respect of the intellectual property of our Group;
(g) the industry report prepared by Frost & Sullivan, the summary of which is set forth
in “Industry Overview;”
APPENDIX V DOCUMENTS DELIVERED TO THE REGISTRAR
OF COMPANIES AND A V AILABLE ON DISPLAY
– V-1 –


--- page 702 ---
(h) the letter of advice prepared by Harney Westwood & Riegels, our legal advisors as
to the laws of the Cayman Islands, summarizing certain aspects of the Cayman
Companies Act as referred to in Appendix III to this prospectus;
(i) the Cayman Companies Act;
(j) the material contracts referred to in “Appendix IV — Statutory and General
Information — B. Further Information about Our Business — 1. Summary of
Material Contracts;”
(k) the written consents referred to in “Appendix IV — Statutory and General
Information — E. Other Information — 8. Qualifications and Consents of Experts;”
(l) the service contracts or letters of appointment referred to in “Appendix IV —
Statutory and General Information — C. Further Information about Our Directors,
Chief Executive and Substantial Shareholders — 2. Particulars of Directors’ Service
Contracts and Letters of Appointment;” and
(m) the terms of the Pre-IPO Equity Incentive Plan.
DOCUMENTS A V AILABLE FOR INSPECTION
A copy of the full list of all the grantees under the Pre-IPO Equity Incentive Plan,
containing all the details as required under Rule 17.02(1)(b) of and paragraph 27 of Appendix
D1A to the Listing Rules and paragraph 10 of Part I of the Third Schedule to the Companies
(Winding Up and Miscellaneous Provisions) Ordinance, will be available for inspection at the
office of Kirkland & Ellis, 26/F, Gloucester Tower, The Landmark, 15 Queen’s Road Central,
Hong Kong during normal business hours up to and including the date which is 14 days from
the date of this prospectus.
APPENDIX V DOCUMENTS DELIVERED TO THE REGISTRAR
OF COMPANIES AND A V AILABLE ON DISPLAY
– V-2 –


--- page 703 ---
