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Shaanxi Micot Pharmaceutical Technology Co., Ltd.
ʮ̡
(A joint stock company incorporated in the People’s Republic of China with limited liability )
Stock Code : 2335
GLOBAL
OFFERING
Joint Sponsors, Overall Coordinators, Sponsor-Overall Coordinators,
Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers


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IMPORTANT: If you have doubt about any of the contents in this prospectus, you should obtain independent professional advice.
Shaanxi Micot Pharmaceutical T echnology Co., Ltd.
ʮ̡
(A joint stock company incorporated in the People’s Republic of China with limited liability)
GLOBAL OFFERING
Number of Offer Shares under the
Global Offering
: 58,054,400 H Shares
(subject to the Over-allotment Option)
Number of Hong Kong Offer Shares : 5,805,600 H Shares (subject to reallocation)
Number of International Offer Shares : 52,248,800 H Shares (subject to reallocation
and the Over-allotment Option)
Maximum Offer Price : HK$21.0 per H Share, plus brokerage of
1.0%, SFC transaction levy of 0.0027%,
AFRC transaction levy of 0.00015% and
the Stock Exchange trading fee of
0.00565% (payable in full on application
in Hong Kong Dollars, subject to refund)
Nominal V alue : RMB0.02 per Offer Share
Stock Code : 2335
Joint Sponsors, Overall Coordinators, Sponsor-Overall Coordinators,
Joint Global Coordinators, Joint Bookrunners and Joint Lead Managers
Joint Bookrunners and Joint Lead Managers
SOMERLEY CAPITAL LIMITED
⳪暲@:9)
Hong Kong Exchanges and Clearing Limited, The Stock Exchange of Hong Kong Limited and Hong Kong Securities Clearing Company Limited take
no responsibility 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 reliance upon the whole or any part of the contents of this prospectus.
A copy of this prospectus, having attached thereto the documents specified in Appendix V “Documents Delivered to the Registrar of Companies in
Hong Kong and Available 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 32 of the Laws of Hong Kong). The Securities and Futures
Commission and the Registrar of Companies in Hong Kong take no responsibility for the contents of this prospectus or any other document referred
to above.
The Offer Price is expected to be fixed by agreement between the Overall Coordinators and us on the Price Determination Date. The Price
Determination Date is expected to be on or before Monday, June 22, 2026. The Offer Price will be not more than HK$21.0 and is currently expected to
be not less than HK$18.20. Applicants for Hong Kong Offer Shares may be required to pay, on application (subject to application channels), the
maximum offer price of HK$21.0 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 should be lower than HK$21.0. If, for any reason,
the Overall Coordinators and us are unable to reach an agreement on the Offer Price at or before 12: 00 noon on Monday, June 22, 2026, the Global
Offering will not proceed and will lapse.
We are incorporated, and a majority of our business is located, in the PRC. Potential investors should be aware of the differences in the legal, economi c
and financial systems between the PRC and Hong Kong and that there are different risk factors relating to investment in PRC-incorporated businesses.
Potential investors should also be aware that the regulatory framework in the PRC is different from the regulatory framework in Hong Kong and
should take into consideration the different market nature of the H Shares. Such differences and risk factors are set out in “Risk Factors” and
“Appendix III — Summary of Articles of Association”.
The obligations of the Hong Kong Underwriters under the Hong Kong Underwriting Agreement to subscribe for, and to procure applicants for the
subscription for, the Hong Kong Offer Shares, are subject to termination by the Overall Coordinators if certain grounds arise prior to 8:00 a.m. on the
day that trading in the Shares commences on the Hong Kong Stock Exchange. Such grounds are set out in the section headed “Underwriting” in this
prospectus.
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
offered, 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 offered only outside the United States in offshore transactions in reliance on Regulation 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 public 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.micot.cn ). If you require a
printed copy of this prospectus, you may download and print from the website addresses above.
IMPORTANT
* For identification purposes only Monday, June 15, 2026


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IMPORTANT NOTICE TO INVESTORS:
FULLY ELECTRONIC APPLICATION PROCESS
We have adopted a fully electronic application process for the Hong Kong
Public Offering. We will not provide printed copies of this prospectus to the
public in relation to the Hong Kong Public Offering.
This prospectus is available at the website of the Stock Exchange at
www.hkexnews.hk under the “ HKEXnews > New Listings > New Listing
Information” section, and our website at www.micot.cn If you require a printed
copy of this prospectus, you may download and print from the websites above.
To apply for the Hong Kong Offer Shares, you may:
(1) apply online through the HK eIPO White Form service at
www.hkeipo.hk;
(2) apply through the HKSCC EIPO channel to electronically cause
HKSCC Nominees to apply on your behalf by instructing your broker or
custodian who is a HKSCC Participant to give electronic application
instructions through 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
prospectus are identical to the printed document as registered with the Registrar of
Companies in Hong Kong pursuant to Section 342C of the Companies (Winding Up
and Miscellaneous Provisions) Ordinance.
If you are an intermediary, broker or agent, please remind your customers,
clients or principals, as applicable, that this prospectus is available online at the
websites above.
Please refer to the section headed “How to Apply for Hong Kong Offer
Shares” in this prospectus for further details of the procedures through which you
can apply for the Hong Kong Offer Shares electronically.
IMPORTANT
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Your application through the HK eIPO White Form service or the HKSCC
EIPO channel must be for a minimum of 200 Hong Kong Offer Shares and in one of
the numbers set out in the table. If you are applying through the HK eIPO White
Form service, you may refer to the table below for the amount payable for the
number of H Shares you have selected. You must pay the respective maximum
amount payable on application in full upon application for Hong Kong Offer Shares.
If you are applying through the HKSCC EIPO channel, you are required to prefund
your application based on the amount specified by your broker or custodian, as
determined based on the applicable laws and regulations in Hong Kong.
No. of Hong
Kong Offer
Shares
applied for
Maximum
Amount
payable (2) on
application/
successful
allotment
No. of Hong
Kong Offer
Shares
applied for
Maximum
Amount
payable (2) on
application/
successful
allotment
No. of Hong
Kong Offer
Shares
applied for
Maximum
Amount
payable (2) on
application/
successful
allotment
No. of Hong
Kong Offer
Shares
applied for
Maximum
Amount
payable (2) on
application/
successful
allotment
HK$ HK$ HK$ HK$
200 4,242.36 3,000 63,635.35 40,000 848,471.40 500,000 10,605,892.50
400 8,484.71 4,000 84,847.15 50,000 1,060,589.26 600,000 12,727,071.00
600 12,727.07 5,000 106,058.93 60,000 1,272,707.10 700,000 14,848,249.50
800 16,969.43 6,000 127,270.71 70,000 1,484,824.96 800,000 16,969,428.00
1,000 21,211.79 7,000 148,482.50 80,000 1,696,942.80 900,000 19,090,606.50
1,200 25,454.14 8,000 169,694.28 90,000 1,909,060.66 1,000,000 21,211,785.00
1,400 29,696.49 9,000 190,906.06 100,000 2,121,178.50 2,000,000 42,423,570.00
1,600 33,938.86 10,000 212,117.86 200,000 4,242,357.00 2,902,800 (1) 61,573,569.50
1,800 38,181.22 20,000 424,235.70 300,000 6,363,535.50
2,000 42,423.56 30,000 636,353.56 400,000 8,484,714.00
(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 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 HK eIPO
White Form Service Provider (for applications made through the application channel of
the HK eIPO White Form service) 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 Global Offering, we will
issue an announcement on the website of our Company at http://www.micot.cn and the
website of the Stock Exchange at http://www.hkexnews.hk .
Hong Kong Public Offering commences ..................... 9:00 a.m. on Monday,
June 15, 2026
Latest time to complete electronic applications
under the HK eIPO White Form service through
the designated website at www.hkeipo.hk (2) ..............1 1:30 a.m. on Thursday,
June 18, 2026
Application lists open (3) ................................1 1:45 a.m. on Thursday,
June 18, 2026
Latest time to give electronic application instructions
to HKSCC (4) ....................................... 12:00 noon on Thursday,
June 18, 2026
Latest time to complete payment of
HK eIPO White Form applications by
effecting internet banking transfer(s) or
PPS payment transfer(s) ............................. 12:00 noon on Thursday,
June 18, 2026
If you are instructing your broker or custodian who is a HKSCC Participant to give
electronic application instructions via HKSCC’s FINI System terminals to apply for the
Hong Kong Offer Shares on your behalf, you are advised to contact your broker or
custodian for the latest time for giving such instructions which may be different from the
latest time as stated above.
Application lists close (3) ............................... 12:00 noon on Thursday,
June 18, 2026
(1) Announcement of the Offer Price, the level of
applications in the Hong Kong Public Offering, the level of
indications of interest in the International Offering
and the basis of allocation of the Hong Kong Offer Shares
to be published on our website at www.micot.cn
(5)
and the website of the Hong Kong Stock Exchange at
www.hkexnews.hk
(5) on or before ...................1 1:00 p.m. on Tuesday,
June 23, 2026
(2) Results of allocations in the Hong Kong Public Offering
to be available through a variety of channels as
described in “How to Apply for Hong Kong Offer Shares —
B. Publication of Results” in this prospectus from .............. 1 1:00 p.m. on
Tuesday, June 23, 2026
(3) A full announcement of the Hong Kong Public Offering
containing (1) and (2) above to be published on
the website of the Stock Exchange at www.hkexnews.hk and
the Company’s website at www.micot.cn (5) f r o m................ 1 1:00 p.m. on
Tuesday, June 23, 2026
Result of allocations in the Hong Kong Public Offering
(with successful applicants’ identification document
numbers, where appropriate) will be available at the
“Allotment Results” page at www.hkeipo.hk/IPOResult
(or www.tricor.com.hk/ipo/result ) with
a “search by ID” function from .................................1 1:00 p.m. on
Tuesday, June 23, 2026
H Share certificates in respect of wholly or
partially successful applications to be despatched or
deposited into CCASS on or before
(6) .................... T uesday, June 23, 2026
EXPECTED TIMETABLE (1)
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HK eIPO White Form e-Auto Refund payment instructions/
refund cheques in respect of wholly or partially
successful applications if the final Offer Price is
less than the price payable on application (if applicable) and
wholly or partially unsuccessful applications pursuant to the
Hong Kong Public Offering to be despatched on or before
(7)(8) ......... W ednesday,
June 24, 2026
Dealings in H Shares on the Hong Kong Stock Exchange
expected to commence at ............................ 9:00 a.m. on Wednesday,
June 24, 2026
Notes:
(1) All dates and times refer to Hong Kong local dates and time, except as otherwise stated. For details of the
structure of the Global Offering, including conditions of the Hong Kong Public Offering, please see
“Structure of the Global Offering” in this prospectus.
(2) You will not be permitted to submit your application through the designated website at www.hkeipo.hk
after 11:30 a.m. on the last day for submitting applications. If you have already submitted your
application through the designated website at www.hkeipo.hk and obtained an application reference
number from the designated website before 11:30 a.m., you will be permitted to continue the application
process (by completing payment of application monies) until 12:00 noon on the last day for submitting
applications, when the application lists close.
(3) If there is/are a tropical cyclone warning signal number 8 or above, a “black” rainstorm warning signal
and/or Extreme Conditions in force in Hong Kong at any time between 9:00 a.m. and 12:00 noon on
Thursday, June 18, 2026, the application lists will not open or close on that day. Please see “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 via HKSCC’s FINI system should see “How to Apply for Hong Kong Offer Shares — A.
Applications for Hong Kong Offer Shares” in this prospectus.
(5) None of the websites or any of the information contained on the websites forms part of this prospectus.
(6) No temporary documents of title will be issued in respect of the Offer Shares. H Share certificates will
only become valid evidence of title provided that (i) the Global Offering has become unconditional and
(ii) neither of the Underwriting Agreements has been terminated in accordance with their terms prior to
8:00 a.m. on the Listing Date. Investors who trade H Shares on the basis of publicly available allocation
details prior to the receipt of H Share certificates or prior to the H Share certificates becoming valid do so
entirely at their own risk.
(7) HK eIPO White Form e-Auto Refund payment instruction/refund cheques will be issued in respect of
wholly or partially unsuccessful applications pursuant to the Hong Kong Public Offering and also in
respect of wholly or partially successful applications in the event that the final Offer Price is less than the
price payable per Offer Share on application.
(8) Applicants who have applied through the HK eIPO White Form service for 1,000,000 or more Hong Kong
Offer Shares may collect H Share certificates in person from our H Share Registrar, Tricor Investor
Services Limited, at 17/F, Far East Finance Centre, 16 Harcourt Road, Hong Kong from 9:00 a.m. to 1:00
p.m. on Wednesday, June 24, 2026 or such other date as notified by us as the date of despatch/collection
of H Share certificates/ HK eIPO White Form e-Auto Refund payment instructions/refund cheques.
Applicants being individuals who are eligible for personal collection may not authorize any other person
to collect on their behalf. If you are a corporate applicant which is eligible for personal collection, your
authorized representative must bear a letter of authorization from your corporation stamped with your
corporation’s chop. Both individuals and authorized representatives must produce, at the time of
collection, evidence of identity acceptable to our H Share Registrar. Applicants who have applied for
Hong Kong Offer Shares through the HKSCC EIPO channel should see the section headed “How to
Apply for Hong Kong Offer Shares — D. Despatch/Collection of H Share Certificates and Refund of
Application Monies” in this prospectus for details.
Applicants who have applied through the HK eIPO White Form service and paid their application
monies through single bank account may have refund monies (if any) despatched to the bank account, in
the form of HK eIPO White Form e-Auto Refund payment instructions. Applicants who have applied
through the HK eIPO White Form service and paid their 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 cheques in favour of the applicant (or, in the case of joint applications,
the first-named applicant), by ordinary post at their own risk.
H Share certificates and/or refund cheques (if applicable) for applicants who have applied for less than
1,000,000 Hong Kong Offer Shares and any uncollected H Share certificates will be despatched by
ordinary post, at the applicants’ risk, to the addresses specified in the relevant applications.
Further information is set out in “How to Apply for Hong Kong Offer Shares — D. Despatch/Collection
of H Share Certificates and Refund of Application Monies” in this prospectus.
The above expected timetable is a summary only. You should refer to “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.
EXPECTED TIMETABLE (1)
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IMPORTANT NOTICE TO INVESTORS
This prospectus is issued by us solely in connection with the Hong Kong Public
Offering and the Hong Kong Offer Shares and does not constitute an offer to sell or a
solicitation of an offer to buy any security other than the Hong Kong Offer Shares offered by
this prospectus pursuant to the Hong Kong Public Offering. This prospectus may not be used
for the purpose of making, and does not constitute, an offer or invitation in any other
jurisdiction or in any other circumstances. No action has been taken to permit a public offering
of the Hong Kong Offer Shares in any jurisdiction other than Hong Kong and no action has
been taken to permit the distribution of this prospectus in any jurisdiction other than Hong
Kong. The distribution of this prospectus for purposes of a public offering and the offering and
sale of the Hong Kong Offer Shares in other jurisdictions are subject to restrictions and may
not be made except as permitted under the applicable securities laws of such jurisdictions
pursuant to registration with or authorization by the relevant securities regulatory
authorities or an exemption therefrom.
You should rely only on the information contained in this prospectus to make your
investment decision. The Hong Kong Public Offering is made solely on the basis of the
information contained and the representations made in this prospectus. We have not
authorized anyone to provide you with information that is different from what is contained in
this prospectus. Any information or representation not made in this prospectus must not be
relied on by you as having been authorised by us, the Joint Sponsors, the Overall Coordinators,
the Joint Global Coordinators, the Joint Bookrunners, the Joint Lead Managers, the
Underwriters, any of our or their respective directors, officers, employees, agents, or
representatives or any other person involved in the Global Offering. Information contained on
our website (www.micot.cn) does not form part of this prospectus.
Page
Expected Timetable ................................................. i i i
Contents .......................................................... v
Summary ......................................................... 1
Definitions ........................................................ 1 3
Glossary of T echnical T erms .......................................... 2 1
Forward-looking Statements .......................................... 2 9
Risk Factors ....................................................... 3 0
Waivers from Strict Compliance with the Listing Rules and Exemption
from Strict Compliance with the Companies (Winding Up and
Miscellaneous Provisions) Ordinance ................................. 5 5
Information about this Prospectus and the Global Offering ................. 6 2
Directors and Parties Involved in the Global Offering ..................... 6 7
Corporate Information ............................................... 7 3
Industry Overview .................................................. 7 5
Regulatory Overview ................................................ 9 2
History, Development and Corporate Structure ........................... 1 1 1
Business .......................................................... 1 3 6
Relationship with our Controlling Shareholders .......................... 2 2 4
Share Capital ...................................................... 2 2 6
Cornerstone Investors ............................................... 2 2 9
Substantial Shareholders ............................................. 2 3 5
Directors and Senior Management ..................................... 2 3 7
Financial Information ............................................... 2 5 0
Future Plans and Use of Proceeds ...................................... 2 7 1
Underwriting ...................................................... 2 7 5
CONTENTS
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Page
Structure of the Global Offering ....................................... 2 8 5
How to Apply for the Hong Kong Offer Shares ........................... 2 9 2
Appendix I — Accountants’ Report ................................ I - 1
Appendix II — Unaudited Pro Forma Financial Information ............ II-1
Appendix III — Summary of Articles of Association ................... III-1
Appendix IV — Statutory and General Information .................... I V - 1
Appendix V — Documents Delivered to the Registrar of Companies and
Available on Display ............................. V - 1
CONTENTS
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This summary aims to give you an overview of the information contained in this
prospectus. As this is a summary, it does not contain all the information that may be
important to you. You should read the entire prospectus carefully before you decide to invest in
the Offer Shares. In particular, we are a biotechnology company seeking a listing on the
Main Board of the Stock Exchange under Chapter 18A of the Listing Rules on the basis
that we are unable to meet the requirements under Rule 8.05 (1), (2) or (3) of the Listing
Rules. Our Core Product is the product for the purpose of satisfying the eligibility
requirements under Chapter 18A of the Listing Rules and Chapter 2.3 of the Guide for New
Listing Applicants. We may continue to incur substantial costs and expenses in relation to
R&D activities for the Core Product, and the Core Product may not be successfully developed
or marketed. Moreover, there are risks associated with any investment. Some of the particular
risks in investing in the Offer Shares are set out in the section headed “Risk Factors” You
should read that section carefully.
OVERVIEW
Who We Are
We are a biotechnology company specializing in the discovery, development and
commercialization of bi-/multi-specific peptide drugs for the treatment of metabolic
diseases as well as cardiovascular and cerebrovascular diseases. We have self-developed a
product pipeline of one Core Product and other six product candidates. Our Core Product
MT1013 is a self-developed, Phase III-stage, dual-targeting receptor agonist polypeptide
that simultaneously targets the CaSR and the OGP receptor, primarily designed for the
treatment of Chronic Kidney Disease-Secondary Hyperparathyroidism (“ CKD-SHPT”)
with potential for expansion into additional indications such as Chronic Kidney
Disease-Mineral and Bone Disorder (“ CKD-MBD”) with osteoporosis and CKD-SHPT not
on Dialysis.
WE MA Y NOT ULTIMATELY BE SUCCESSFUL IN DEVELOPING AND/OR
COMMERCIALIZING OUR CORE PRODUCT OR ANY OF OUR OTHER PIPELINE
PRODUCTS
All of the drug candidates have been in-house developed by us. The chart below
summarizes the development status of our clinical-stage product candidates as of the
Latest Practicable Date:
SUMMARY
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Core product Key product
MT200605
Drug Candidates Target/Mechanism Indication RegionTreatment
regimen
IND and IND
Preparation Phase I Phase II Phase III Current Status/Projected Milestones Commercialization
Rights
Metabolic drugs
CaSR/OGP
CKD-SHPT
PRC Complete Phase III clinical trial
by the end of 2026 Global(2)
U.S.
CKD-MBD with Osteoporosis PRC Commence Phase III clinical trial
in early 2028
(1)
Global
CKD-SHPT not on Dialysis PRC File IND by the end of 2027
GLP-1R/
GCGR/MasR
Weight management for
obesity or overweight
PRC Complete Phase I clinical trial
in Q2 of 2026
U.S.
Proteinuric CKD PRC Complete Phase I clinical trial
in Q2 of 2026
MASH PRC File IND in early 2027
MT2004 FXR
(small-molecule)
DILI PRC Complete Phase II clinical trial
by the end of 2027
MASLD
PRC
U.S.
CLD PRC Commence Phase II clinical trial
by the end of 2027
(3)
PTH1R/OGP
GIOP
PRC Commence Phase I clinical trial
in January 2026
U.S.
PMO
PRC Commence Phase I clinical trial
in January 2026
U.S.
Cardio-cerebrovascular drugs
Coagulation
Factor II/
GP IIb/IIIa
ACS-PCI PRC Complete Phase IIb
(4) clinical trial
by mid-2028
Global
U.S.
Stroke PRC Commence Phase II clinical trial(5)(6)
by June 2026
HD
PRC Commence Phase II clinical trial(5)(7)
by July 2026
U.S.
HD-PF4 PRC Commence Phase II clinical trial
by the end of 2027
(5)
TrKB
(small-molecule) AIS
PRC Complete Phase II clinical trial in 2026
U.S.
MT1011 NOACs
(small-molecule)
Universal Anticoagulant
Reversal Agent PRC
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy Complete Phase I clinical trial
in Q2 of 2026
MT1013
XTL6001
MT1009
MT1002
Directly proceed to the next stage Currently evaluating the competitive landscape and formulating the future Clinical Development Plan
Abbreviation: CaSR: Calcium-Sensing Receptor; OGP: Osteogenic Growth Peptide; CKD-MBD: Chronic Kidney Disease-Mineral and Bone Disorder; GLP-1R: Glucagon-like Peptide-1 Receptor; GCGR: Glucagon Receptor; MasR: Mas Receptor;
MASH: Metabolic Dysfunction-associated Steatohepatitis; FXR: Farnesoid X Receptor; DILI: Drug-Induced Liver Injury; MASLD: Metabolic Dysfunction-associated Steatotic Liver Disease; CLD: Cholestatic Liver Disease; PTH1R: Parathyroid hormone 1 receptor; GIOP: Glucocorticoid-Induced Osteoporosis;
PMO: Postmenopausal Osteoporosis; GP IIb/IIIa: Glycoprotein IIb/IIIa Complex; ACS: Acute Coronary Syndrome; PCI: Percutaneous Coronary Intervention; HD: hemodialysis; HD-PF4: HD with heparin-platelet factor 4 complex positive; PF-4: Platelet Factor-4; AIS: acute ischemic stroke; TrkB:
Tyrosine kinase receptor B; NOACs: Novel Oral Anticoagulants
SUMMARY
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Notes:
(1) We have completed Phase II clinical trial of the relevant product for the indication of CKD-SHPT, and as patients with CKD-SHPT are all within the CKD-MBD
population, we plan to leverage data collected from respective trials to seek IND approvals from competent regulatory authorities to conduct Phase III clinical trial
of the relevant product for the expanded indication of CKD-MBD with Osteoporosis.
(2) Researched and developed in-house. We have granted Everest Medicines (China) Co., Ltd. (“ Everest”) the exclusive right to sell, commercialize and promote MT1013
for the treatment of CKD-SHPT in Mainland China, Hong Kong, Macao and the Taiwan region as well as the Asia-Pacific region (excluding Japan) (the “ T erritory”).
We reserved the rights to: (i) research, develop and manufacture MT1013 globally; (ii) commercialize MT1013 for any indications outside Territory; and (iii)
commercialize MT1013 in the Territory for any indications other than CKD-SHPT. For more information, see “Business — Commercialization”.
(3) The Phase I clinical trial of MT2004 had conducted adequate safety and dose-ranging evaluation to support the therapeutic dose range for the treatment of MASLD
and CLD in the PRC, thereby providing the basis for directly commencing the respective Phase II clinical trials.
(4) The Phase IIb clinical trial forms part of MT1002-II-C04 and was conducted to further evaluate the selected dose(s) in a larger patient population. For more
information, see “Business — Our Key Product MT1002 — Clinical Trial Overview of MT1002 — MT1002-II-C04 PRC Phase II Efficacy Study in ACS-PCI Patients ”.
(5) The Phase I clinical trial of MT1002 had conducted adequate safety and dose-ranging evaluation to support the therapeutic dose range for the treatment of stroke, HD
and HD-PF4 in the PRC, thereby providing the basis for directly commencing the respective Phase II clinical trials.
(6) In June 2023, we obtained IND approval from the NMPA to conduct a Phase II clinical trial of MT1002 for stroke. Trial preparation was initiated in March 2026,
including the finalization of the clinical trial protocol.
(7) In July 2023, we obtained IND approval from the NMPA to conduct a Phase II clinical trial of MT1002 for HD. Trial preparation was initiated in March 2026, including
the finalization of the clinical trial protocol.
SUMMARY
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Our Core Product — MT1013
Our Core Product, MT1013, is a dual-targeting receptor agonist polypeptide that
simultaneously targets the CaSR and the OGP receptor. MT1013 is primarily developed
with CKD-SHPT as its leading indication and is planned to expand into additional
indications including CKD-MBD with Osteoporosis and CKD-SHPT not on Dialysis.
MT1013’s clinical studies have demonstrated the following:
• MT1013 demonstrated a roughly 2.5-fold higher comprehensive control rate
of iPTH, serum calcium, and serum phosphorus compared to etelcalcetide in a
head-to-head Phase II evaluation.
• MT1013 showed onset of efficacy within three weeks and sustained control of
iPTH levels by week nine, as observed in a Phase II trial.
• MT1013 exhibited cardiovascular benefit potential. MT1013 was associated
with greater FGF23 reduction, a biomarker directly linked to cardiovascular
risk in CKD-SHPT, alongside effective control of iPTH, serum calcium, and
serum phosphorus.
• MT1013 showed a generally favorable safety and tolerability profile, with no
severe hypocalcemia reported across clinical trials.
• MT1013 enhanced bone mineral density and metabolism. A Phase II study
suggested that MT1013 was associated with improved bone turnover,
metabolism, and remodeling balance in CKD-SHPT patients.
The above safety and efficacy profiles are based on findings from early phase(s) of
clinical trials and cannot be viewed as definitive. For more information of the clinical
results, see “Business — Clinical Trial Overview of MT1013”.
CKD-SHPT is caused by CKD as the primary disease, and its therapeutic approach
must be determined on an individualized basis, taking into account the stage of the
underlying disease, disease severity, serum calcium and phosphate levels, vitamin D
metabolism, the degree of PTH elevation and comorbidities. Therapy of CKD-SHPT is
primarily symptomatic and progressive in nature, following a stepwise and
comprehensive treatment principle. Accordingly, treatment options vary according to
individual patient conditions, including phosphate-lowering therapy, vitamin D or
vitamin D analogues and calcimimetics etc. The foregoing treatment principles are
consistent with prevailing international and domestic clinical guidelines and published
reviews, including the KDIGO 2017 Clinical Practice Guideline Update for CKD-MBD and
the Chinese Guidelines for the Diagnosis and Treatment of Chronic Kidney
Disease-Mineral and Bone Disorder, neither of which classifies CKD-SHPT treatment into
formal first-line, second-line or subsequent-line therapies. Frost & Sullivan further
confirmed that there is no formal classification of CKD-SHPT treatment into any line of
treatment.
We are actively expanding the indications for our Core Product MT1013 into areas
such as CKD-MBD with Osteoporosis and CKD-SHPT not on Dialysis in light of the Phase
II clinical results, which showed a positive effect on improving bone mineral density.
As of the Latest Practicable Date, MT1013 completed its Phase II clinical trials
(MT1013-II-C01 and MT1013-II-C03) for the treatment of CKD-SHPT and has commenced
a Phase III clinical trial with Cinacalcet as the active comparator, and all 424 planned
patients have been enrolled. Etelcalcetide and Cinacalcet are approved CaSR agonist
drugs, for more information, see “Industry Overview — Competitive landscape of CaSR
agonist”. In respect of the commercialization of MT1013, we have entered into an
agreement with Everest. For more information, see “Business — Commercialization”.
The market size of CKD-SHPT drugs in the PRC is estimated to reach RMB5.0 billion
by 2030 and RMB13.1 billion by 2035, with the CAGR of 21.4%. In 2025, the global number
for CKD-SHPT patients reached 160.4 million, and is expected to increase to 188.0 million
by 2030.
Our Key Products
XTL6001
Our Key Product, XTL6001, is a GLP-1R/GCGR/MasR tri-target agonist that has
received IND approval in both the PRC and the U.S. and has entered the clinical trial
stage. The introduction of MasR into the target panel of GLP-1R/GCGR is novel among
current GLP-1 drugs, with potential applications in the treatment of diseases such as
SUMMARY
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Chronic Weight Management in Obese or Overweight Populations, Proteinuric CKD, and
MASH. XTL6001’s preclinical studies have demonstrated its ability to preserve muscle
mass, achieve weight loss through enhanced energy metabolism-driven mechanisms and
deliver multi-organ protection. Phase I clinical trial data show that weekly XTL6001
dosing for 4-5 weeks achieves clinically meaningful reductions in waist circumference
driven by visceral fat loss (markedly outperforming hip circumference changes), coupled
with robust lipid lowering (TG, LDL-C, ApoB), reduced serum uric acid, and enhanced
uric acid clearance, indicating its potential for multimodal cardiometabolic and renal risk
control.
XTL6001 had obtained IND approvals in both the PRC and the United States for the
treatment of Chronic Weight Management in Obese or Overweight Populations. As of the
Latest Practicable Date, the LPLV (Last Patient Last Visit) occurred and the database lock
was completed.
The global population affected by metabolic diseases continues to rise, with obesity
becoming an increasingly severe issue. The overweight and obesity drug market in the
PRC is expected to reach RMB23.5 billion in 2030 and RMB107.3 billion in 2035, with a
CAGR of 35.5% from 2030 to 2035. The GLP1R polypeptide drug market in China is
expected to grow to RMB81.4 billion in 2030 and RMB176.9 billion in 2035, with a CAGR of
16.8% from 2030 to 2035.
MT1002
Our Key Product, MT1002, is a coagulation factor II and GP IIb/IIIa dual-targeting
peptide antagonist, primarily designed for clinical needs in anticoagulation and
anti-thrombosis for indications such as ACS-PCI, Stroke, HD and HD-PF4. MT1002’s
clinical studies have demonstrated its potential to address the bleeding and ischemia
balance in ACS-PCI, with a fast onset of action, recovery after discontinuation, stable
pharmacokinetic profile, and favorable population adaptability.
MT1002 had successfully completed Phase I clinical trials in both the PRC and the
United States for the treatment of ACS-PCI. A Phase II clinical trial is underway in the
PRC. As of the Latest Practicable Date,five dose-exploration cohorts involving a total of 24
subjects have been completed, and enrollment of 26 subjects in the dose-expansion cohort
was completed. In addition, commencement of Phase II clinical trials for Stroke and HD in
the PRC is expected by June 2026 and July 2026, respectively.
In 2025, the antithrombotic drugs market in China reached RMB34.5 billion. It is
estimated that the antithrombotic drugs market in China will grow to RMB47.2 billion in
2030, and RMB61.8 billion in 2035, with a CAGR of 6.4% from 2025 to 2030 and 5.6% from
2030 to 2035, respectively.
MT200605
Our Key Product, MT200605, is a neuroprotectant for injection. Its core
breakthrough lies in a dual synergistic mechanism of action — by simultaneously
activating the TrkB receptor and eliminating oxygen radicals, it blocks the post-AIS
pathological cascade via dual pathways. MT200605’s clinical studies have demonstrated
its favorable safety and tolerability profile, as well as dual-pathway synergistic
neuroprotective effects, offering a therapeutic option for patients.
As of the Latest Practicable Date, MT200605 has successfully completed Phase I
clinical studies in both the PRC and the United States. A Phase II clinical trial is underway
in the PRC, and enrollment of 360 subjects has been completed.
In 2025, the market size neuroprotective drugs in China reached RMB11.7 billion. It
is estimated that the neuroprotective agent market in China will grow to RMB15.7 billion
in 2030, and RMB24.6 billion in 2035, with a CAGR of 6.2% from 2025 to 2030 and 9.3%
from 2030 to 2035 respectively.
OUR TECHNOLOGY PLATFORMS
We have established four core technology platforms, including (i) Bi-/Multi-specific
Peptide and Peptide-based Macromolecule Technology Platform, (ii) Computer-Aided
Peptide Design Platform, (iii) Oral Peptide Delivery Platform, and (iv) Druggability
Evaluation Platform. These platforms collectively span the entire R&D continuum from
basic research, drug discovery research, drug development research to NDA submission
and serve as the foundational engine driving the advancement of our differentiated
peptide-based pipeline. For details, see “Business — Our Technology Platforms”.
SUMMARY
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RESEARCH AND DEVELOPMENT
For the years ended December 31, 2024 and 2025, our R&D expenses amounted to
RMB107.0 million and RMB130.1 million, respectively. We have been focusing our
in-house R&D efforts on the development of our Core Product, MT1013. For the years
ended December 31, 2024 and 2025, we incurred R&D expenses for MT1013 in amounts of
RMB66.7 million and RMB84.4 million respectively, representing 62.3% and 64.9% of our
total R&D expenses for the same period, respectively. As of the Latest Practicable Date, we
had a team of 117 R&D professionals, representing approximately 80.7% of our total staff
count.
INTELLECTUAL PROPERTY
As of the Latest Practicable Date, we owned (i) 10 granted patents in the PRC, three
granted patents in Hong Kong, 23 granted patents overseas, and (ii) three patent
applications in the PRC, three patent applications in Hong Kong, 9 patent applications
overseas and one PCT patent application. With respect to our Core Product MT1013, we
owned (i) four granted patents, including one in the PRC, one in Hong Kong, one in Japan
and one in Australia, and (ii) four patent applications, including one in the U.S., one in
Europe, one in Canada and one in Korea.
PRODUCTION
At current stage, as all our manufactured products are investigational drugs for
clinical trial use, we arrange production schedules in accordance with clinical
development plans and outsource the manufacturing of both active pharmaceutical
ingredients (APIs) and drug products to third-party Contract Development and
Manufacturing Organizations (CDMOs). Our CMC R&D center, comprising the CMC
quality department, API department, formulation department and analytical department,
provides support throughout the drug development process. Our CMC platform covers
the key CMC development stages for APIs, formulations and sustained-release
preparations. Leveraging this platform, our CMC R&D team is capable of independently
conducting key activities including API process development, formulation process
development and API scale-up at kilogram level.
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 MT1013 in early 2028, we will implement a dual-track
commercialization approach: domestically through collaborations with third party
Contract Sales Organizations (CSOs) and internationally via license-out partnerships.
During the Track Record Period and up to the Latest Practicable Date, we had no
commercialized drugs on the market either in China or overseas. When our drug
candidates progress to commercialization in the future, we will determine their prices
based on various factors, such as current medical needs, our drugs’ pharmacoeconomic
evaluation, our production costs, prices of prior line treatment options, competitive
landscape and prices of competing drugs, differences in features between our drugs and
competing drugs, and health economics in the country to market in. For more information,
see “Business — Commercialization”.
SUPPLIERS AND PROCUREMENT
During the Track Record Period, we procure clinical and pre-clinical services, as
well as administrative and operational services, from suppliers. For the years ended
December 31, 2024 and 2025, the aggregate purchases attributable to our five largest
suppliers in each year during the Track Record Period amounted to RMB31.3 million and
RMB26.8 million, respectively, representing 39.5% and 27.6% of our total purchases for the
respective periods. Purchases attributable to our single largest supplier in each year
amounted to RMB7.6 million and RMB8.6 million for the same years, accounting for 9.6%
and 8.9% of our total purchases for the respective periods.
COMPETITION
Our industry is highly competitive and subject to significant change. While we
believe that our technology platforms, our drug candidates and our experienced
management team provide us with competitive advantages, we face potential competition
from many others working to develop therapies targeting the same indications. These
include major biopharmaceutical companies, specialty pharmaceutical and biotechnology
companies, and academic institutions, government agencies and research institutions.
SUMMARY
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Any drug candidates that we successfully develop and commercialize will compete both
with existing drugs and with any new drugs that may become available in the future. For
more information on the competitive landscape of our drug candidates, please see
“Industry Overview” in this prospectus.
RISK FACTORS
Our business and the Global Offering involve certain risks as set out in “Risk
Factors” in this prospectus. You should read that section in its entirety carefully before
you decide to invest in our H Shares. Some of our major risks we face include but are not
limited to: (i) We face intense competition particularly from other peptide drugs with
similar targets. Our competitors may discover, develop or commercialize competing
drugs earlier or more successfully than we do; (ii) Our business and financial prospects
depend substantially on the success of our clinical stage and pre-clinical stage product
candidates, and we may be unable to successfully complete the clinical development,
obtain relevant regulatory approvals or we may experience significant delays in doing so;
(iii) Adverse events or undesirable side effects in clinical trials could interrupt, delay 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; (iv) 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; (v) We may not
be able to identify or discover new drug candidates, or to identify additional therapeutic
opportunities for our drug candidates; (vi) We have little experience in manufacturing
biopharmaceutical products on a large commercial scale and our business could be
materially and adversely affected if we encounter problems in manufacturing our future
drug products; (vii) We have limited experience in launching and marketing drug
products. If we are unable to leverage third-party sales networks or build and manage our
in-house commercialization team, we may not successfully commercialize our drug
products; and (viii) Our drug candidates may fail to achieve or maintain the degree of
market acceptance, and the actual scale of market sales of our product candidates may be
smaller than we anticipate, which could render some product candidates ultimately
unprofitable even if commercialized.
OUR STRENGTHS
We believe the following competitive strengths have contributed to our success and
differentiate us from our competitors. (i) Scientific insights facilitating our development
of next-generation bi-/multi-specific peptide drugs; (ii) Core Product MT1013 as the
dual-targeting receptor agonist polypeptide targeting CaSR and OGP receptor, with
demonstrated improvements in comprehensive control rate and patient survival benefits;
(iii) Differentiated pipeline targeting high-potential areas with significant unmet clinical
needs; (iv) Integrated end-to-end platform covering the full value chain from discovery to
commercialization, enabling accelerated global expansion; and (v) Management team
comprised of experts in peptide drug development.
OUR STRATEGIES
We intend to pursue the following strategies to further grow our business. (i)
Accelerate clinical development and commercialization of our Product Candidates; (ii)
Focus on clinical needs and advance peptide drug candidates with mechanisms and
commercialisation potential; (iii) Deepen strategic collaborations to unlock the clinical
and commercial potential of our Product Candidates; and (iv) Recruit and retain talent to
promote systematic training and sustainable development.
SUMMARY OF HISTORICAL FINANCIAL INFORMATION
This summary of key financial information set forth below has been derived from,
and should be read in conjunction with, the Accountants’ Report in Appendix I to, and
“Financial Information” of, this prospectus. Our historical financial information was
prepared in accordance with IFRS Accounting Standards.
SUMMARY
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Summary of Consolidated Statements of Profit or Loss and Other Comprehensive Income
For the Year Ended
December 31,
2024 2025
RMB’000 RMB’000
Other income ........................... 4,002 2,301
Other gains and losses, net ................ 2,670 43,268
Administrative expenses .................. (18,812) (23,490)
Research and development expenses ......... (107,022) (130,089)
Listing expenses ........................ – (9,901)
Finance costs ........................... (37,646) (67,003)
Loss before tax .......................... (156,808) (184,914)
Income tax expense ...................... (24) –
Loss for the year ........................ (156,832) (184,914)
Our other gains and losses, net increased by 1,503.7% from RMB2.7 million for 2024
to RMB43.3 million for 2025, primarily due to gain on non-substantial modification of
redemption liabilities arising from an extension of the redemption date in relation to our
Pre-IPO Investment, partially offset by (i) a decrease in gain on fair value changes from
financial assets at FVTPL which was in turn primarily due to a decrease in interest rates
applicable to our financial assets at FVTPL, and (ii) a decrease in gains of early
termination of a lease.
Our research and development expenses increased by 21.6% from RMB107.0 million
for 2024 to RMB130.1 million for 2025, primarily due to (i) an increase in experiments and
tests expenses, and (ii) an increase in staff costs and welfare expenses for our R&D
personnel, in connection with our R&D activities with respect to, in particular, our Core
Product, MT1013, and a Key Product, MT200605.
Our finance costs increased by 78.2% from RMB37.6 million for 2024 to RMB67.0
million for 2025, primarily attributable to the increase in interest expenses on redemption
liabilities.
We recorded net losses of RMB156.8 million and RMB184.9 million for 2024 and
2025, respectively, primarily in relation to: (i) our ongoing investment in R&D activities,
(ii) the increase in interest expenses on redemption liabilities which will be reclassified to
equity upon Listing, and (iii) partially offset by the increase in other gains and losses, net.
For details, see “Financial Information — Description of Selected Components of
Consolidated Statements of Profit or Loss and Other Comprehensive Income”.
Summary of Consolidated Statements of Financial Position
As at December 31,
2024 2025
RMB’000 RMB’000
Total non-current assets .................. 61,281 69,260
Total current assets ...................... 185,977 262,201
Total current liabilities ................... 77,932 266,407
Total non-current liabilities ................ 42,533 1,024,939
Net current assets (liabilities) .............. 108,045 (4,206)
Total equity (deficits) ..................... 126,793 (959,885)
As of December 31, 2025, we recorded net current liabilities of RMB4.2 million
compared to net current assets of RMB108.0 million as of December 31, 2024, primarily
because (i) part of the non-current portion of our bank borrowings became current, and (ii)
redemption liabilities of RMB134.3 million were classified as current liabilities.
SUMMARY
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As of December 31, 2025, we recorded net liabilities of RMB959.9 million, compared
to net assets of RMB126.8 million as of December 31, 2024, primarily because of (i) the
redemption liabilities recognized for the shares with preferential rights amounting to
RMB1,137.3 million and (ii) loss for the year ended December 31, 2025 amounting to
RMB184.9 million, partially offset by the capital injection from shareholders amounting to
RMB235.5 million. We expect our net liabilities position to turn into net assets position
upon Listing as certain investors’ redemption rights will be terminated and the financial
liabilities recognized for those rights will be released upon Listing.
For details, see “Financial Information — Discussion of Certain Selected Items from
the Consolidated Statements of Financial Position”.
Summary of Consolidated Statements of Cash Flows
For the Year Ended
December 31,
2024 2025
RMB’000 RMB’000
Net Cash used in Operating Activities ............ (107,742) (137,130)
Net Cash from (used in) Investing Activities ....... 54,803 (57,582)
Net Cash from Financing Activities .............. 21,123 212,235
Net (Decrease) Increase in Cash and Cash
Equivalents ............................... (31,816) 17,523
Cash and Cash Equivalents at the Beginning of the
Y e a r ...................................... 95,942 64,661
Effect of Foreign Exchange Rate Changes ......... 5 3 5 (1,628)
Cash and Cash Equivalents at the End of the Year . . . 64,661 80,556
During the Track Record Period, we incurred negative cash flows from our
operations and our operating cash outflows mainly resulted from our research and
development expenses.
For details, see “Financial Information — Liquidity and Capital Resources — Cash
Flows”.
OUR CONTROLLING SHAREHOLDERS
As of the Latest Practicable Date, Dr. Wang Bing ( ˮΏ), Dr. Wang Mei (ˮૠ) and
Xi’an Zhongrui directly held 40.56%, 6.60% and 5.48% of the interest in our Company,
respectively. Dr. Wang Bing and Dr. Wang Mei are spouses. Dr. Wang Mei and Dr. Wang
Bing held 99.00% and 1.00% of the equity interest, respectively, in Xi’an Zhongrui Zekang
Enterprise Management Consulting Co., Ltd.* (ʮ̡)
(“Zhongrui Zekang ”), which acts as the general partner of Xi’an Zhongrui. Xi’an
Zhongrui directly held 5.48% of the equity interest in the Company, such that Dr. Wang
Mei and Dr. Wang Bing are deemed to be the beneficial owners of the 5.48% equity interest
in the Company held by Xi’an Zhongrui. Therefore, Dr. Wang Bing, Dr. Wang Mei, Xi’an
Zhongrui and Zhongrui Zekang will be regarded as our Controlling Shareholders under
the Listing Rules before the Listing.
Immediately upon completion of the Global Offering (assuming the Over-allotment
Option is not exercised), Dr. Wang Bing, Dr. Wang Mei, Xi’an Zhongrui and Zhongrui
Zekang will collectively be entitled to exercise approximately 43.43% voting rights in our
Company and thus remain as our Controlling Shareholders.
PRE-IPO INVESTORS
We have attracted certain Pre-IPO Investors and undergone six rounds of financing
as of the Latest Practicable Date. Our Pre-IPO Investors include Sophisticated Investors,
such as Northern Light Venture Capital ( ̏฽Έ௴ҳ) and NRL Capital (ॲဧл༟͉), who
have made meaningful investment in our Company in accordance with Chapter 2.3 of the
Guide for New Listing Applicants. As of the Latest Practicable Date, Northern Light
Venture Capital (through Beta Achieve) and NRL Capital (through Suzhou Mainiv) held
approximately 6.48% and 9.99%, respectively, of our Company’s total issued share capital,
and will hold approximately 5.35% and 8.24%, respectively, upon the Listing (assuming
that the Over-allotment Option is not exercised). For details, see “History, Development
and Corporate Structure — Pre-IPO Investment — 3. Information about our Pre-IPO
Investors”.
SUMMARY
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To the best knowledge of our Directors, save as disclosed below, each of the Pre-IPO
Investors and their respective ultimate beneficial owners is an independent third party,
and has no relationship with any connected persons of our Company or other Pre-IPO
Investors.
GLOBAL OFFERING STATISTICS
The statistics in the following table are based on the assumptions that (i) the Global
Offering has been completed and 58,054,400 H Shares are newly issued in the Global
Offering, (ii) the Over-allotment Option for the Global Offering is not exercised, and (iii)
331,740,350 Shares are issued and outstanding following the completion of the Global
Offering:
Based on an
Offer Price of
HK$18.20 per
Share
Based on an
Offer Price of
HK$21.00 per
Share
Market capitalization of our Shares (1) . . . HK$6,037.7
million
HK$6,966.5
million
Unaudited pro forma adjusted net
tangible (liabilities) assets per Share (2) . HK$(0.37) HK$0.12
Notes:
(1) The calculation of market capitalization is based on 331,740,350 Shares expected to be in issue
immediately upon completion of the Global Offering (assuming the Over-allotment Option is not
exercised). The number of Shares in calculating the market capitalization is different from that in
calculating the unaudited pro forma adjusted net tangible liabilities per Share as set out in note
(2) below is primarily because the number of treasury shares are not excluded from the total
number of Shares when calculating the market capitalisation. Those treasury shares refer to
shares held by Xi’an Zhongrui, the Pre-IPO Share Incentive Plan of the Company and was treated
as treasury shares under the relevant accounting treatment. However, those Shares held by Xi’an
Zhongrui would be converted into H Shares and listed on the Stock Exchange, hence they are not
excluded from the total share capital of the Company or the calculation of market capitalization.
(2) The unaudited pro forma adjusted net tangible (liabilities) assets per Share as of December 31,
2025 is calculated after making the adjustments referred to in Appendix II and on the basis that
316,740,350 Shares are expected to be in issue immediately upon completion of the Global
Offering (assuming the Over-allotment Option is not exercised).
(3) No adjustment has been made to the unaudited pro forma adjusted consolidated net tangible
assets (liabilities) of the Group attributable to owners of the Company as at December 31, 2025 to
reflect any trading result or other transactions of the Group entered into subsequent to December
31, 2025. In particular, the unaudited pro forma adjusted consolidated net tangible liabilities of
the Group attributable to owners of the Company as shown in Appendix II to this prospectus have
not been adjusted to illustrate the effect of the termination of the redemption and other
preferential rights granted to the investors of Series A, B, B1, C and D Financings upon
completion of the Global Offering (“ T ermination of Preferential Rights ”), which would result in
the reclassification of the redemption liabilities with carrying amount of RMB1,159,018,000 as at
December 31, 2025 to equity.
Assuming the Series D Financing, Termination of Preferential Rights, Share Subdivision and
Global Offering had been completed on December 31, 2025, the unaudited pro forma adjusted
consolidated net tangible (liabilities) assets of the Group attributable to owners of the Company
would have adjusted by RMB1,159,018,000, resulting in unaudited pro forma adjusted
consolidated net tangible assets of the Group attributable to the owners of the Company of
RMB1,057,188,000 and RMB1,192,806,000, based on an Offer Price of HK$18.2 and HK$21.0 per H
Share, respectively. The unaudited pro forma adjusted consolidated net tangible assets of the
Group attributable to owners of the Company as at December 31, 2025 per Share after Termination
of Preferential Rights would have been RMB3.34 per Share (approximately HK$3.84 per Share)
and RMB3.77 per Share (approximately HK$4.33 per Share), respectively, calculated on the basis
of 316,740,350 Shares in issue and based on an Offer Price of HK$18.2 and HK$21.0 per H Share.
For details, please see “Unaudited Pro Forma Financial Information” in Appendix II to this
prospectus.
For the calculation of the unaudited pro forma adjusted net tangible asset value per
Share attributed to our Shareholders, see “Unaudited Pro Forma Financial Information” in
Appendix II to this prospectus.
SUMMARY
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FUTURE PLANS AND USE OF PROCEEDS
We estimate that we will receive net proceeds of approximately HK$1,067.2 million
after deducting the underwriting fees and expenses payable by us in the Global Offering
assuming an Offer Price of HK$19.60 per Offer Share, being the mid-point of the indicative
Offer Price range of HK$18.20 to HK$21.00 per Offer Share set out in this prospectus. We
intend to use the net proceeds from the Global Offering for the following purposes: (i)
approximately 39.1%, or HK$417.3 million, will be used for ongoing and planned clinical
trials and planned commercial launch of our Core Product; (ii) approximately 36.3%, or
HK$387.4 million, will be used for ongoing and planned clinical trials and planned
commercial launch of our Key Products; (iii) approximately 14.6%, or HK$155.8 million,
will be used for the R&D of our other product candidates and technology platforms; and
(iv) approximately 10.0%, or HK$106.7 million, will be used for working capital and
general corporate purposes.
DIVIDENDS
No dividend has been proposed, paid or declared by our Company since its
incorporation. As of the Latest Practicable Date, we did not have a formal dividend policy
or fixed dividend payout ratio. We do not have any plan to declare or pay any dividends in
the foreseeable future. The determination of whether to pay a dividend and in which
amount is based on factors the Board may deem relevant. Any dividend distribution will
also be subject to the approval of the Shareholders in the Shareholder’s meeting. Under
the PRC law and the Articles of Association, the general reserve requires annual
appropriations of 10% of after-tax profits at each year-end until the balance reaches 50% of
the relevant PRC entity’s registered capital. In view of our accumulated losses, as advised
by our PRC Legal Advisor, according to the relevant PRC laws and regulations and the
Articles of Association, we shall not declare or pay dividend until the accumulated losses
are covered by our after-tax profits and sufficient statutory common reserve are drawn in
accordance with the relevant laws, regulations and our Articles of Association.
LISTING EXPENSES
Listing expenses to be borne by us are estimated to be approximately RMB61.4
million (including underwriting commission, at the Offer Price of HK$19.60 per H Share,
being the midpoint of the indicative Offer Price range of HK$18.20 to HK$21.00 per H
Share), which represent 6.2% of the gross proceeds from the Global Offering, assuming no
Shares are issued pursuant to the Over-allotment Option. The above listing expenses are
comprised of (i) underwriting-related expenses, including sponsor fee and underwriting
commission, of RMB39.6 million, and (ii) non-underwriting-related expenses of RMB21.8
million, including (a) the legal advisors and the reporting accountants’ expenses of
RMB13.0 million, and (b) other fees and expenses of RMB8.8 million. Approximately
RMB19.4 million of our listing expenses shall be charged to our consolidated statements of
profit or loss, among which, approximately RMB9.9 million has been charged during the
Track Record Period, and approximately RMB42.0 million is expected to be deducted from
equity upon Listing. The listing expenses above are the latest practicable estimate for
reference only, and the actual amount may differ from this estimate.
APPLICATION FOR LISTING ON THE STOCK EXCHANGE
We have applied to the Listing Committee for the granting of the listing of, and
permission to deal in, our H Shares to be converted from the Unlisted Shares, our H Shares
to be issued pursuant to the Global Offering (including any H Shares which may be issued
pursuant to the Over-allotment Option). No part of our H Shares is listed on or dealt in on
any other stock exchange, and no such listing or permission to list is being or proposed to
be sought in the near future.
Under section 44B(1) of the Companies (Winding Up and Miscellaneous Provisions)
Ordinance, any allotments made in respect of any applications will be invalid if the listing
of, and permission to deal in, the Offer Shares on the 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.
SUMMARY
–1 1–


--- page 20 ---
RECENT DEVELOPMENT
Clinical Development
The Phase III clinical trial of MT1013 for CKD-SHPT was initiated in July 2025. As of
the Latest Practicable Date, all 424 planned patients have been enrolled. The Phase I
clinical trial of XTL6001 for overweight and obesity was initiated in June 2025. As of the
Latest Practicable Date, the LPLV had occurred and the database lock had been completed.
Expected Net Loss in 2026
We expect to record an increase in net loss in 2026, primarily due to (i) our continued
investment in R&D as we advance the development of our drug candidates, and (ii) an
increase in share-based payment expenses.
Progress in Commercialization
In February 2026, in respect of the commercialization of MT1013 for the treatment of
CKD-SHPT in Asia-Pacific (excluding Japan), we entered into an agreement with Everest.
For more information, see “Business — Commercialization”.
NO MATERIAL ADVERSE CHANGE
Our Directors confirm that, up to the date of this prospectus, there has been no
material adverse change in our operations, financial performance, market position or
prospects since December 31, 2025, being the end date of the periods reported on in the
Accountants’ Report in Appendix I to this prospectus, and there is no event since
December 31, 2025 that would materially affect the information as set out in the
Accountants’ Report in Appendix I to this prospectus.
SUMMARY
–1 2–


--- page 21 ---
In this prospectus, unless the context otherwise requires, the following terms and
expressions shall have the meanings set out below. Certain other terms are explained in
“Glossary of Technical Terms.”
“Accountants’ Report” the accountants’ report of our Company, the text of
which is set out in “Appendix I”
“affiliate(s)” with respect to any specified person, any other
person, directly or indirectly, controlling or controlled
by or under direct or indirect common control with
such specified person
“AFRC” Accounting and Financial Reporting Council of Hong
Kong
“Articles of Association” or
“Articles”
the articles of association of our Company adopted on
September 19, 2025 with effect from the Listing Date,
as amended, supplemented or otherwise modified
from time to time, a summary of which is set out in
“Appendix III — Summary of Articles of Association”
“associate(s)” has the meaning ascribed to it under the Listing Rules
“Audit Committee” audit committee of our Board
“Board” or “Board of Directors” the board of Directors of our Company
“business day” a day on which banks in Hong Kong are generally
open for normal business to the public and which is
not a Saturday, Sunday or public holiday in Hong
Kong
“CAGR” the compound annual growth rate, annualized
average growth rate between given years, assuming
growth takes place at an exponentially compound rate
“Capital Market
Intermediary(ies)”
the capital market intermediary(ies) participating in
the Global Offering as set out in “Directors and
Parties Involved in the Global Offering” in this
prospectus
“CCASS” Central Clearing and Settlement System established
and operated by HKSCC
“China”, “Mainland China”
or “PRC”
the People’s Republic of China, but for the purpose of
this prospectus and for geographical reference only
and except where the context requires otherwise,
references in this prospectus to “China” and the
“PRC” do not apply to Hong Kong, the Macau Special
Administrative Region and Taiwan Region
“close associate(s)” has the meaning ascribed to it under the Listing Rules
“Companies Ordinance” 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 or supplemented from time
to time
DEFINITIONS
–1 3–


--- page 22 ---
“Company” or “our Company” Shaanxi Micot Pharmaceutical Technology Co., Ltd.
(ʮ̡), established
under the laws of the PRC on 19 January 2007 as a
limited liability company and converted into a joint
stock company under the laws of the PRC on January
17, 2025
“Company Law” or “PRC
Company Law”
the Company Law of the PRC ( ʕശɛ͏΍ձ਷ʮ̡
), as amended, supplemented or otherwise
modified from time to time
“Controlling Shareholder(s)” has the meaning ascribed thereto under the Listing
Rules and unless the context requires otherwise,
refers to Dr. Wang Bing, Dr. Wang Mei, Xi’an
Zhongrui and Xi’an Zhongrui Zekang Enterprise
Management Consulting Co., Ltd* ( Гτ଺๿ዣੰΆุ
ʮ̡), further details of which are set out
in “Relationship with our Controlling Shareholders”
“connected persons(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 connected person” has the meaning ascribed to it under the Listing Rules
“Core Product” has the meaning ascribed to it in Chapter 18A of the
Listing Rules, and for the purpose of this prospectus,
our core product refers to MT1013
“Corporate Governance Code” the Corporate Governance Code as set out in
Appendix C1 to the Listing Rules
“CSDC” China Securities Depository and Clearing
Corporation Limited (ப΂ʮ̡ )
“CSRC” the China Securities Regulatory Commission ( ʕ਷ᗇ
ึ)
“Deed of Indemnity” the deed of indemnity dated June 10, 2026 entered
into by Dr. Wang Bing and Dr. Wang Mei, our
Controlling Shareholders in favor of our Company
(for our Company and as trustee for each of our
subsidiaries)
“Director(s)” the director(s) of our Company
“Domestic Share(s)” ordinary share(s) in the share capital of our Company
with a nominal value of RMB0.02 each upon the
completion of the Share Subdivision, which is/are
subscribed for and paid up in RMB; before the
completion of the Share Subdivision, ordinary
share(s) in the share capital of our Company with a
nominal value of RMB1.00 each, which is/are
subscribed for and paid up in RMB
“Employee Incentive
Platform(s)”
the employee shareholding platform(s) of our
Company, namely Xi’an Zhongrui
“Exchange Participant(s)” a person (a) who, in accordance with the Listing
Rules, may trade on or through the Hong Kong Stock
Exchange; and (b) whose name is entered in a list,
register or roll kept by the Hong Kong Stock Exchange
as a person who may trade on or through the Hong
Kong Stock Exchange
DEFINITIONS
–1 4–


--- page 23 ---
“Extreme Conditions” the occurrence of “extreme conditions” as announced
by any government authority of Hong Kong due to
serious disruption of public transport services,
extensive flooding, major landslides, large-scale
power outage or any other adverse conditions before
Typhoon Signal No. 8 or above is replaced with
Typhoon Signal No. 3 or below
“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
possessing of specified information on subscription in
and settlement for all new listing of equity securities
or interests issued by a new applicant, irrespective of
whether there is an offering of equity securities or
interests
“Frost & Sullivan” or “Industry
Consultant”
Frost & Sullivan (Beijing) Inc., Shanghai Branch Co.,
our industry consultant, an independent market
research and consulting company
“Global Offering” the Hong Kong Public Offering and the International
Offering
“General Rules of HKSCC” the General Rules of HKSCC as may be amended or
modified from time to time and where the context so
permits, shall include the HKSCC Operational
Procedures
“Group,” “our Group,”
“we,” “our” or “us”
our Company and its subsidiaries (or our Company
and any one or more of its subsidiaries, as the context
may require)
“Guide for New Listing
Applicants”
the Guide for New Listing Applicants issued by the
Stock Exchange, as amended, supplemented or
otherwise modified from time to time
“H Share(s)” ordinary share(s) in the share capital of our Company
with a nominal value of RMB0.02 each upon the
completion of the Share Subdivision, which will be
subscribed for and traded in Hong Kong dollars and
listed on the Stock Exchange; before the completion of
the Share Subdivision, ordinary share(s) in the share
capital of our Company with a nominal value of
RMB1.00 each, which will be subscribed for and
traded in Hong Kong dollars and listed on the Stock
Exchange
“H Share Registrar” Tricor Investor Services Limited
“HK eIPO White Form” the application for Hong Kong Offer Shares to be
issued in the applicant’s own name by submitting
applications online through the designated website at
www.hkeipo.hk
“HK eIPO White Form
Service Provider”
the HK eIPO White Form service provider designated
by our Company, as specified on the designated
website at www.hkeipo.hk
“HKSCC” Hong Kong Securities Clearing Company Limited, a
wholly-owned subsidiary of Hong Kong Exchanges
and Clearing Limited
DEFINITIONS
–1 5–


--- page 24 ---
“HKSCC EIPO” 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 a HKSCC Participant to give
electronic application instructions via HKSCC’s FINI
system to apply for the Hong Kong Offer Shares on
your behalf
“HKSCC Nominees” HKSCC Nominees Limited, a wholly-owned
subsidiary of HKSCC
“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” or “HK” the Hong Kong Special Administrative Region of the
PRC
“Hong Kong dollars” or “HK$” Hong Kong dollars, the lawful currency of Hong
Kong
“Hong Kong Offer Shares” 5,805,600 H Shares initially offered by us for
subscription at the Offer Price pursuant to the Hong
Kong Public Offering
“Hong Kong Public Offering” the offer of the Hong Kong Offer Shares for
subscription by the public in Hong Kong (as set out in
“Structure of the Global Offering”) at the Offer Price
and on, and subject to, the terms and conditions
described in this prospectus
“Hong Kong Underwriters” the underwriters as set out in “Underwriting — Hong
Kong Underwriters”
“Hong Kong Underwriting
Agreement”
the underwriting agreement dated June 12, 2026
relating to the Hong Kong Public Offering, entered
into by, among others, our Company, the Controlling
Shareholders, the Joint Sponsors and the Hong Kong
Underwriters, as set out in “Underwriting”
“IFRS” International Financial Reporting Standards
“Independent Third Party(ies)” any entity(ies) or person(s) who is not a connected
person of our Company or an associate of any such
entity(ies) or person(s) within the meanings ascribed
thereto under the Listing Rules
“International Offering” the offer of the International Offer Shares by the
International Underwriters at the Offer Price, outside
the United States in offshore transactions in
accordance with Regulation S, as set out in “Structure
of the Global Offering”
DEFINITIONS
–1 6–


--- page 25 ---
“International Offer Shar es” 52,248,800 H Shares (subject to the exercise of the
Over-allotment Option as set out in “Structure of the
Global Offering”) initially offered by our Company
pursuant to the International Offering
“International Underwriters” the underwriters of the International Offering
“International Underwriting
Agreement”
the international underwriting agreement relating to
the International Offering, which is expected to be
entered into by, among others, our Company, our
Controlling Shareholders, the Joint Sponsors and the
International Underwriters on or around the Price
Determination Date, as set out in “Underwriting”
“Jinan Liuji” Jinan Liuji Enterprise Management Partnership
Enterprise (Limited Partnership)* (ʬ᝘Άุ၍ଣ
Υྫ)
“Joint Bookrunners” the joint bookrunners as named in “Directors and
Parties Involved in the Global Offering”
“Joint Global Coordinators” the joint global coordinators as named in “Directors
and Parties Involved in the Global Offering”
“Joint Lead Managers” the joint lead managers as named in “Directors and
Parties Involved in the Global Offering”
“Joint Sponsors”,
“Sponsor-Overall
Coordinators” and “Overall
Coordinators”
the joint sponsors, overall coordinators, and
sponsor-overall coordinators as named in “Directors
and Parties Involved in the Global Offering”
“Latest Practicable Date” June 7, 2026, being the latest practicable date for the
purpose of ascertaining certain information contained
in this prospectus prior to its publication
“Linhai Qize” Linhai Qize Maite Venture Investment Partnership
(Limited Partnership) ( ᑗऎ઼̹ዣ௥त௴ุҳ༟ΥྫΆ
Υྫ)
“Listing” the listing of the H Shares on the Main Board of the
Stock Exchange
“Listing Committee” the listing sub-committee of the Stock Exchange
“Listing Date” the date expected to be on or about Wednesday, June
24, 2026, on which the H Shares are listed and from
which dealings therein are permitted to take place on
the Main Board of the Stock Exchange
“Listing Rules” the Rules Governing the Listing of Securities on The
Stock Exchange of Hong Kong Limited, as amended,
supplemented or otherwise modified from time to
time
“Maicheng Century” Maicheng Century (Xi’an) Enterprise Management
Partnership Enterprise (Limited Partnership)* ( ௥༐˰
Υྫ)
“Main Board” the stock market (excluding the option market)
operated by the Stock Exchange which is independent
from and operated in parallel with the GEM of the
Stock Exchange
DEFINITIONS
–1 7–


--- page 26 ---
“Nasdaq” National Association of Securities Dealers Automated
Quotations
“NDRC” National Development and Reform Commission of
the PRC (ึ )
“Nomination Committee” the nomination committee of our Board
“Offer Price” the final offer price per H Share (exclusive of a
brokerage fee of 1.0%, a SFC transaction levy of
0.0027%, a 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 set out in “Structure of the Global
Offering — Pricing and Allocation”
“Offer Share(s)” the Hong Kong Offer Shares and/or the International
Offer Share(s), as the context may require
“Over-allotment Option” the option expected to be granted by our Company to
the International Underwriters, exercisable by the
Overall Coordinator (for itself and on behalf of the
International Underwriters), pursuant to which our
Company may be required to allot and issue up to an
aggregate of 8,708,000 additional H Shares,
representing up to 15.0% of the Offer Shares initially
being offered under the Global Offering, at the Offer
Price to, among other things, to cover over-allocations
in the International Offering, if any, details of which
are set out in “Structure of the Global Offering —
Over-allotment Option”
“PBOC” the People’s Bank of China ( ʕ਷ɛ͏ვБ), the central
bank of the PRC
“PRC Company Law” Company Law of the PRC (),
as amended, supplemented or otherwise modified
from time to time
“PRC Legal Advisor” JunHe LLP , our legal advisor as to PRC law
“PRC Intellectual Property
Legal Advisor”
Tian Yuan Law Firm, our legal advisor as to PRC
intellectual property law
“Pre-IPO Investment(s)” the investment(s) in our Company undertaken by the
Pre-IPO Investors, the details of which are set out in
“History, Development and Corporate Structure”
“Pre-IPO Investor(s)” the investor(s) as set out in “History, Development
and Corporate Structure”
“Price Determination Date” the date expected to be on or around Monday, June 22,
2026, but no later than 12:00 noon on Monday, June 22,
2026, on which our Company and the Overall
Coordinators (for itself and on behalf of the
Underwriters) determine the Offer Price for the
purpose of the Global Offering
“prospectus” this prospectus being issued in connection with the
Hong Kong Public Offering
DEFINITIONS
–1 8–


--- page 27 ---
“R&D” research and development
“Regulation S” Regulation S under the U.S. Securities Act
“Remuneration Committee” the remuneration committee of our Board
“RMB” or “Renminbi” Renminbi, the lawful currency of the PRC
“SFC” Securities and Futures Commission of Hong Kong
“SFO” Securities and Futures Ordinance (Chapter 571 of the
Laws of Hong Kong), as amended, supplemented or
otherwise modified from time to time
“Shaanxi Innovation Relay” Shaanxi Innovation Relay Equity Investment
Partnership (Limited Partnership)* (ᛆ
Υྫ)
“Shaanxi Jingang” Shaanxi Jingang Nongtou Biomedical Industry
Development Equity Investment Partnership
(Limited Partnership)* (ᔼᖹପุ೯
Υྫ)
“Share(s)” ordinary share(s) in the share capital of our Company
with a nominal value of RMB0.02 each upon the
completion of the Share Subdivision; before the
completion of the Share Subdivision, ordinary
share(s) in the share capital of our Company with a
nominal value of RMB1.00 each, comprising Unlisted
Share(s) and H Share(s)
“Share Subdivision” the subdivision of each share in our Company’s share
capital with a nominal value of RMB1.00 each into 50
shares with a nominal value of RMB0.02 each effective
immediately prior to the Listing
“Shareholder(s)” holder(s) of the Share(s)
“Sophisticated Investor(s)” has the meaning ascribed to it under Chapter 2.3 of
the Guide for New Listing Applicants issued by the
Stock Exchange
“Stabilising Manager” CCB International Capital Limited
“State Council” The State Council of the People’s Republic of China
(ʕശɛ͏΍ձ਷਷ਕ৫)
“Stock Exchange” or
the “Hong Kong
Stock Exchange”
The Stock Exchange of Hong Kong Limited
“subsidiary(ies)” has the meaning ascribed to it under the Listing Rules
“substantial Shareholder(s)” has the meaning ascribed to it under the Listing Rules
“Supervisor(s)” the supervisor(s) of our Company
“Takeovers Code” the Codes on Takeovers and Mergers and Share
Buybacks issued by the SFC, as amended,
supplemented or otherwise modified from time to
time
“Track Record Period” the two years ended December 31, 2024 and 2025
DEFINITIONS
–1 9–


--- page 28 ---
“treasury shares” has the meaning ascribed to it under the Listing Rules
“Underwriters” the Hong Kong Underwriters and the International
Underwriters
“Underwriting Agreements” the Hong Kong Underwriting Agreement and the
International Underwriting Agreement
“Unlisted Share(s)” ordinary share(s) in the share capital of our Company
with a nominal value of RMB0.02 each upon the
completion of the Share Subdivision, which is/are not
listed on any stock exchange; before the completion of
the Share Subdivision, ordinary share(s) in the share
capital of our Company with a nominal value of
RMB1.00 each, which is/are not listed on any stock
exchange
“U.S.” or “United States” the United States of America, its territories and
possessions, any state of the United States and the
District of Columbia
“U.S. dollars”, “US$” or “USD” the United States dollars, the lawful currency of the
U.S.
“U.S. Securities Act” the United States Securities Act 1933, as amended or
supplemented from time to time
“Xi’an Zhongrui” Xi’an Zhongrui Hongyuan Information Technology
Partnership (Limited Partnership) (ࢹڦ
Υྫ), a limited partnership
established under the laws of the PRC on July 18,
2019, an employee incentive platform of our
Company
“Zhongrui Zekang” Xi’an Zhongrui Zekang Enterprise Management
Consulting Co., Ltd.ࠢ
ʮ̡) a limited liability company incorporated under
the laws of the PRC on July 10, 2019, a General Partner
of Xi’an Zhongrui
“%” percent
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.
For the purpose of this prospectus, references to “provinces” of China include provinces,
municipalities under direct administration of the central government and provincial-level
autonomous regions.
Certain amounts and percentage figures included in this prospectus have been subject to
rounding. Accordingly, figures shown as totals in certain tables may not be an arithmetic
aggregation of the figures preceding them. Any discrepancies in any table or chart between the
total shown and the sum of the amounts listed are due to rounding.
DEFINITIONS
–2 0–


--- page 29 ---
This glossary contains definitions of certain technical terms used in this prospectus in
connection with us and our business. These may not correspond to standard industry
definitions and may not be comparable to similarly terms adopted by other companies.
“absorption” within the context of drug metabolism, the process by
which drug compounds and other molecules move
across cells and tissues such as the gastrointestinal
tract into the circulatory system
“ACS” acute coronary syndromes
“ACS-PCI” Acute Coronary Syndrome-Percutaneous Coronary
Intervention. ACS patients who undergo
percutaneous coronary intervention (PCI) procedures
“ADMET” Absorption, Distribution, Metabolism, Excretion and
Toxicity
“AIDD” artificial intelligence for drug design
“AIS” acute ischemic stroke
“API” active pharmaceutical ingredient, the component of a
drug product that is intended to furnish
pharmacological activity or other direct effect in the
diagnosis, cure, mitigation, treatment, or prevention
of disease, or to affect the structure or any function of
the body
“AMD” age-related macular degeneration
“ANG-(1-7)” Angiotensin-(1-7), an important biologically active
molecule
“BMI” body mass index, a numerical value calculated from
height and weight, providing a standardized measure
to classify underweight, healthy weight, being
overweight, and obesity
“CADD” computer aided drug design
“CaSR” calcium-sensing receptor ,aGp r otein-coupled
receptor located on the cell membrane
“CDE” the Center for Drug Evaluation of the NMPA
“CDMO” contract development and manufacturing
organization, a company that serves other companies
in the pharmaceutical industry on a contract basis,
providing drug development and drug
manufacturing services
“CHD” consumer health data
“Cinacalcet” a CaSR agonist drug approved by the FDA and the
NMPA for the treatment of CKD-SHPT and
Hypercalcemia
“CKD” chronic kidney disease
GLOSSARY OF TECHNICAL TERMS
–2 1–


--- page 30 ---
“CKD-MBD” the coexistence of chronic kidney disease, mineral and
bone disorder (CKD-MBD) and either osteoporosis or
low bone mass (osteopenia)
“CKD-SHPT” chronic kidney disease-secondary hyperparathyroidism,
specifically at the advanced stage of CKD where
maintenance hemodialysis is necessary, unless the
context indicates otherwise
“CLD” cholestatic liver disease
“clinical trial” an experiment done in clinical research
“CMC” chemistry, manufacturing, and controls, a term for the
chemical composition, formulation, and quality
control processes used in the manufacturing of a drug
“Comprehensive Control Rate” the pr oportion achieving all three targets (iPTH,
serum calcium, and serum phosphorus)
simultaneously, where iPTH is maintained at 2-9
times the upper limit of normal (130-586 pg/mL),
serum calcium at 2.10-2.50 mmol/L, and serum
phosphorus at 1.13-1.78 mmol/L
“COVID-19” coronavirus disease 2019, a disease caused by a novel
virus designated as severe acute respiratory
syndrome coronavirus
“CRO” contract research organization, a company that
provides research services to pharmaceutical and
biotechnology companies on a contract basis
“DILI” drug-induced liver injury, liver damage caused by the
drug itself and/or its metabolites or due to
hypersensitivity or reduced tolerance to the drug due
to special physical conditions during drug use DIO
mouse model
“distribution” in the context of DMPK, the process by which
molecules are transported throughout the body
“double-blind” a type of clinical trial in which neither the participants
nor the researcher knows which treatment or
intervention participants are receiving until the
clinical trial is completed
“DKD” diabetic kidney disease
“DMPK” Drug Metabolism and Pharmacokinetics
“EAP” Efficacy Assessment Period
“ERAS” enhanced recovery after surgery
“Etelcalcetide” a CaSR agonist drug approved by the FDA and the
NMPA for the treatment of CKD-SHPT
“FDA” the United States Food and Drug Administration, a
federal agency of the Department of Health and
Human Services
“FGF23” fibroblast growth factor 23
GLOSSARY OF TECHNICAL TERMS
–2 2–


--- page 31 ---
“FPI” first patient in
“FXR” Farnesoid X Receptor
“GA” geographic atrophy
“GCP” good clinical practice, an international ethical and
scientific quality standard for the performance of a
clinical trial on medicinal products involving humans
“GFR” glomerular filtration rate, a quantitative measure of
kidney function reflecting the volume of plasma
filtered by the glomeruli per unit time
“GLP” good laboratory practice, a quality system of
management controls for research laboratories and
organizations to try to ensure the uniformity,
consistency, reliability, reproducibility, quality and
integrity of chemical and pharmaceuticals
non-clinical safety tests
“GIOP” glucocorticoid-induced osteoporosis
“GLP-1” glucagon-like peptide-1, a peptide hormone that
exerts biological function through activation of GLP-1
receptors, which are expressing in various organs and
tissues in the body, including adipose tissue, the liver,
the cardiovascular system, and the central nervous
system. In pancreatic islets, GLP-1 stimulates insulin
secretion and suppresses glucagon release.
Importantly, GLP-1 can increase cell regeneration.
Furthermore, GLP-1-based therapy can also suppress
appetite, delay gastric emptying, regulate blood lipid
metabolism and reduce fat deposition
“GLP-1R/GLP1R” glucagon-like peptide-1 receptor
“GLP-1 based therapy” a class of therapy that mimics the biological function
of GLP-1 for the treatment of diabetes, obesity and
being overweight, metabolic dysfunction-associated
steatohepatitis, other metabolic diseases and
Alzheimer’s disease
“GLP-1 receptor agonist/
GLP-1 RA”
a class of drug that activates the GLP-1 receptor for
the treatment of diabetes, obesity and being
overweight, metabolic dysfunction-associated
steatohepatitis, other metabolic diseases
“glucagon” a hormone that raises blood sugar levels by signaling
the liver to release stored glucose
“glucagon receptor” or “GCGR” a protein that is activated by glucagon that is a target
of interest for developing innovative drugs for the
treatment of diabetes
“GMP” good manufacturing practice, a quality system
imposed on pharmaceutical firms to ensure that
products produced meet specific requirements for
identity, strength, quality and purity, and enforced by
public agencies, for example the FDA
“GPŘ b/řa” Glycoprotein llb/llla Complex
GLOSSARY OF TECHNICAL TERMS
–2 3–


--- page 32 ---
“GI side effect” gastrointestinal side effect
“HD-PF4” hemodialysis (HD) with heparin-platelet factor 4
complex positive
“half-life” the time required for a quantity of substance to reduce
to half of its initial quantity
“HD” hemodialysis, clearing metabolic waste and excess
water from the blood through extracorporeal
circulation for renal replacement therapy in patients
with acute and chronic renal failure
“hit to lead” critical early-stage drug discovery process that
involves optimizing initially identified “hits”
(compounds showing desired biological activity in
initial screens) into “leads” (promising drug
candidates with improved potency, selectivity,
pharmacokinetic properties, and preliminary safety
profiles)
“ICH E1” The Extent of Population Exposure to Assess Clinical
Safety for Drugs Intended for Long-Term Treatment of
Non-Life-Threatening Conditions E1, a clinical safety
guideline issued by the International Council for
Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use on October 27, 1994,
which provides guidance on the extent of patient
exposure generally considered appropriate for the
safety assessment of drugs intended for long-term
treatment of non-life-threatening conditions
“IND” investigational new drug, an application in the drug
review process required by a regulatory authority to
decide whether a new drug is permitted to initiate
clinical trials
“in vitro activity validation” the pr ocess of confirming and characterizing the
biological activity, potency, and specificity of a
compound outside a living organism
“in vivo exposure” the administration of a compound to a living
organism and the subsequent measurement of its
systemic exposure, distribution, metabolism, and
elimination over time
“in vitro druggability
assessment”
an early-stage evaluation process in drug discovery
that uses cell-free or cell-based assays to determine
whether a biological target is amenable to modulation
by drug-like molecules
“in vivo druggability
assessment”
the evaluation of a compound’s potential to exert its
intended pharmacological effect in a living organism
“insulin” a hormone that regulates blood glucose levels by
facilitating the uptake of glucose from blood into cells
and inhibiting the liver from producing more glucose
“in vitro” latin for “within the glass”, referring to studies that
are performed with biological molecules outside their
normal biological context
GLOSSARY OF TECHNICAL TERMS
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“in vivo” latin for “within the living”, referring to studies in
which the effects of various biological molecules are
tested on whole, living organisms or cells, usually
animals, including humans, and plants, as opposed to
a tissue extract or dead org
“iPTH” intact parathyroid hormone
“KOR” kappa opioid receptor
“liver fibrosis” the excessive accumulation of extracellular matrix
proteins including collagen that occurs in most types
of chronic liver diseases
“LPLV” last patient last visit
“MACE” major adverse cardiovascular events
“MAH” the marketing authorisation holder, the entity that
obtains a drug registration certificate from the
relevant drug regulatory authority, who is allowed to
market and sell a drug in the approved region and is
responsible for the entire lifecycle of the drug,
including R&D, manufacturing, marketing, and usage
“MAFLD” metabolic dysfunction-associated fatty liver disease, a
range of liver conditions in individuals with
metabolic dysfunction
“MAPK/ERK” a conserved signaling cascade (mitogen-activated
protein kinase/extracellular signal-regulated kinase)
that transmits extracellular stimuli to the nucleus,
controlling cell growth, differentiation, migration,
and apoptosis, implicated in inflammation and tissue
repair
“MASLD” metabolic dysfunction-Associated steatotic liver
disease
“MASH” metabolic dysfunction-associated steatohepatitis, the
liver manifestation of a metabolic disorder, and the
most severe form of MAFLD
“MaSR” Mas receptor
“MBD” mineral and bone disorder
“metabolic disease” a kind of disorder that disrupts normal metabolism,
the body’s natural process of converting food into
nutrients on a cellular level
“monotherapy” the use of a single therapy
“MRCT” multi-regional clinical trial, clinical trials conducted
across multiple regions of the world
“NACE” net adverse clinical events
“NASH” non-alcoholic steatohepatitis
“NDA” new drug application, the formal application to the
FDA or NMPA proposing approval of a new
pharmaceutical product for sale and marketing
GLOSSARY OF TECHNICAL TERMS
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“NIHSS” National Institutes of Health Stroke Scale
“NMPA” the National Medical Products Administration of the
PRC (္ຖ၍ଣ҅ )
“NSTEMI” non-ST-segment elevation myocardial infarction
“obesity” the abnormal or excessive fat accumulation in the
body
“OGP” osteogenic growth peptide, a polypeptide consisting
of 14 amino acid residues
“onset” the amount of time it takes for a drug to start
producing its therapeutic effects after administration
“overweight” a term used to refer an excess body weight relative to
height
“Proteinuric CKD” chronic kidney disease characterized by persistent
proteinuria
“PCI” percutaneous coronary intervention, a non-surgical,
invasive procedure with a goal to relieve the
narrowing or occlusion of the coronary artery and
improve blood supply to the ischemic tissue
“PCT patent application” a patent application filed under the Patent
Cooperation Treaty (PCT), an international patent law
treaty, concluded in 1970, which provides a unified
procedure for filing patent applications to protect
inventions in each of its contracting states
“pharmacodynamics” or “PD” pharmacodynamics, the study of how a drug affects
an organism, which, together with pharmacokinetics,
influences dosing, benefit, and adverse effects of the
drug
“pharmacology” the branch of medicine concerned with the uses,
effects, and modes of action of drugs
“PK” pharmacokinetics, the study of the bodily absorption,
distribution, metabolism, and excretion of drugs,
which, together with pharmacodynamics, influences
dosing, benefit, and adverse effects of the drug
“placebo” a medical treatment or preparation with no specific
pharmacological activity
“PMO” postmenopausal osteoporosis, a common disease
related to aging
“pre-clinical” a stage preceding a clinical stage
“PCC” pr eclinical candidate compounds, candidate
molecules identified as having further development
potential during the drug discovery phase through
target validation, lead compound optimization, and
in vitro/in vivo experimental validation
GLOSSARY OF TECHNICAL TERMS
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“PLCγ ” phospholipase C gamma, a cytosolic enzyme that
hydrolyzes phosphatidylinositol 4,5-bisphosphate
(PIP2) into inositol 1,4,5-trisphosphate (IP3) and
diacylglycerol (DAG), initiating calcium signaling
and protein kinase C (PKC) activation to mediate cell
responses like contraction and secretion
“Pre-NDA” pre-marketing communication for new drugs
“PTH” parathyroid hormone
“PTH1R” parathyroid hormone receptor 1
“p-TrkB” phospho-TrkB (Tyr705)
“P2Y12 receptor antagonists” a class of important antiplatelet agents that prevent
and treat thrombosis by blocking the P2Y12 receptor
on the platelet surface, thereby inhibiting platelet
aggregation
“PI3K/Akt” a key intracellular signaling pathway activated by
growth factors and cytokines, regulating cell
proliferation, survival, metabolism, and
angiogenesis, frequently dysregulated in cancer and
cardiovascular disorders
“QA” quality assurance, the systematic efforts taken to
assure that a drug meets with all the quality
expectations
“QC” a process by which a company reviews the quality of
all factors involved in the production of a drug
“RAS inhibitor” a class of medications that blocks the
renin-angiotensin-aldosterone system (RAS), used to
treat hypertension, heart failure, and kidney disease
by reducing vasoconstriction and fluid retention
“SAE” the adverse medical event that results in death, is
life-threatening, causes permanent or significant
disability, requires hospitalization or extends hospital
stays
“SAR” structure-activity relationship
“SGLT2 inhibitors” oral hypoglycemic agents that inhibit sodium-glucose
cotransporter 2 in the kidneys, promoting urinary
glucose excretion to lower blood sugar, with proven
cardioprotective and renoprotective effects in type 2
diabetes, heart failure, and chronic kidney disease
“STEMI” ST-Elevation myocardial infarction, a type of ACS
characterized by complete occlusion of a coronary
artery, leading to transmural myocardial ischemia
and necrosis
“SMO” Site Management Organization, an organization that
provides clinical trial related services to a CRO, a
pharmaceutical company, a biotechnology company, a
medical device company or a clinical site
GLOSSARY OF TECHNICAL TERMS
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“Stroke” acute brain injury caused by sudden rupture or
blockage of cerebral blood vessels, resulting in
ischemia and hypoxia of brain tissue
“TEAE” Treatment-Emergent Adverse Event
“TrkB” one of the tyrosine kinase receptors
“Universal Anticoagulant
Reversal Agent”
a therapeutic compound capable of neutralizing the
anticoagulant effects of multiple classes of
anticoagulants
GLOSSARY OF TECHNICAL TERMS
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This prospectus contains, and the documents incorporated by reference herein may
contain, forward-looking statements representing our goals, beliefs, expectations,
intentions or predictions for the future. These forward-looking statements are contained
principally in “Summary,” “Risk Factors,” “Industry Overview,” “Business,” “Financial
Information” and “Future Plans and Use of Proceeds.” Forward-looking statements
typically can be identified by the use of words such as “aim,” “anticipate,” “aspire,”
“believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goals,” “intend,”
“may,” “objective,” “ought to,” “outlook,” “plan,” “potential,” “project,” “schedules,”
“seek,” “should,” “target,” “vision,” “will,” “would” and other similar terms.
Forward-looking statements reflect the current views of the Directors 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 those listed in “Risk Factors,” which are beyond our control and
may cause our actual results, performance or achievements to be materially different from
any future results, performance or achievements expressed or implied by the
forward-looking statements.
Our forward-looking statements have been based on assumptions and factors
concerning future events that may prove to be inaccurate. Those assumptions and factors
are based on information currently available to us about the businesses that we operate.
The risks, uncertainties and other factors, many of which are beyond our control, that
could influence actual results include, but are not limited to:
• our operations and business prospects;
• our business and operating strategies and our ability to implement such
strategies;
• our future business development, financial condition and results of
operations;
• our ability to develop and manage our operations and business;
• our ability to control costs and expenses;
• our capital expenditure plan;
• our expectations regarding demand for and market acceptance of our
products and services;
• our expectations regarding our relationships with customers, suppliers and
other partners to conduct our business;
• our planned use of proceeds;
• future developments, trends and competitive landscape in the industries and
markets in which we operate or plan to operate;
• relevant government policies and regulations relating to our industry;
• capital market developments in Hong Kong and the PRC; and
• economic, political and business conditions in the PRC.
By their nature, certain disclosures relating to these and other risks are only
estimates. Should one or more of these risks or uncertainties, among others, materialize,
or should the underlying assumptions prove to be incorrect, actual results may vary
materially from those estimated, anticipated or projected, as well as from historical
results. Accordingly, you should not place undue reliance on any forward-looking
statements.
Any forward-looking statement speaks only as of the date on which such statement
is made. Except as required by applicable laws, rules and regulations, including the
Listing Rules, we undertake no obligation to update any forward-looking statement to
reflect events or circumstances after the date on which such statement is made or to reflect
the occurrence of unanticipated events. Statements of, or references to, our intentions or
those of any of the Directors are made as of the date of this prospectus. Any such
intentions may change in light of future developments. All forward-looking statements in
this prospectus are expressly qualified by reference to this cautionary statement.
FORWARD-LOOKING STATEMENTS
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In addition to other information in this prospectus, you should carefully consider the
following risk factors before making any investment decision in relation to our H Shares. Any
of the following risks may materially and adversely affect our business, financial condition or
results of operations, or otherwise cause a decrease in the trading price of our H Shares and
cause you to lose part or all of the value of your investment in our H Shares.
RISKS RELATING TO OUR BUSINESS AND INDUSTRY
We face intense competition particularly from other peptide drugs with similar targets.
Our competitors may discover, develop or commercialize competing drugs earlier or
more successfully than we do.
Our Company faces competition from global biopharmaceutical companies,
including companies with substantially greater financial, technical, manufacturing,
marketing and commercialization resources than us, particularly from other peptide
drugs with similar targets. For example, our Core Product, MT1013, is a dual-target
peptide agonist simultaneously acting on CaSR and OGP and is currently in development
for CKD-SHPT as its lead indication. However, as of the Latest Practicable Date, there
were two CaSR agonist drugs approved by the FDA and three CaSR agonist drugs
approved by the NMPA, as well as five CaSR agonist drug candidates for CKD-SHPT at
the clinical stage globally, including peptide-based therapies targeting similar pathways.
In addition, existing therapies for CKD-SHPT, including cinacalcet, evocalcet and
etelcalcetide, have established market presence and physician recognition. We also face
intense competition in relation to our Key Product XTL6001 in the GLP-1-based obesity
and metabolic disease treatment market. As of the Latest Practicable Date, there were 17
triple-target GLP1R peptide drug candidates for overweight and obesity at the clinical
stage globally, among which 12 drug candidates target GLP-1R, GCGR and GIPR, two
drug candidates target GLP-1R, GCGR, and FGF21, one drug candidate targets GLP1R,
GIPR, and AMYR, and one drug candidate targets GLP1R, GIPR, and NPY2R. XTL6001 is
the only triple-target GLP-1R peptide drug candidate targeting GLP-1R, GCGR, and
MASR. Competing products may be approved earlier, achieve broader market acceptance
or demonstrate superior efficacy, safety, convenience or pricing advantages over our
products. As a result, if competing products are approved earlier, achieve broader market
acceptance or demonstrate superior efficacy, safety, convenience or pricing advantages
over our products, our competitive position, business, financial condition, results of
operations and prospects could be materially and adversely affected.
Our commercial opportunities may deteriorate if our competitors develop and
commercialize drugs that are safer, more effective, more convenient, or less expensive
than our products. Our competitors may also obtain approval from the NMPA, the FDA,
or other comparable regulatory authorities for their drugs more quickly than we do,
which could result in them establishing a stronger market position.
Our business and financial prospects depend substantially on the success of our
clinical stage and pre-clinical stage product candidates, and we may be unable to
successfully complete the clinical development, obtain regulatory approvals or we may
experience significant delays in doing so.
Our ability to generate revenue and realize profitability depends on the successful
completion of the development of our product candidates, obtaining regulatory
approvals, which is contingent upon various factors. Such factors may include:
• successful completion of pre-clinical studies, enrollment in and completion of
clinical trials, and favorable safety and efficacy data meeting the clinical trial
endpoints therefrom;
• receipt of regulatory approvals;
• performance by CROs or other third parties of their duties in accordance with
our trial protocols and applicable laws;
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• obtaining, maintaining, protecting and enforcing our intellectual property
and proprietary protection and regulatory exclusivity, and ensuring we do not
infringe, misappropriate or otherwise violate any intellectual property and
proprietary rights of third parties; and
• continued acceptable safety profile following regulatory approval.
While we have invested significant efforts and financial resources in the
development, regulatory approval of our product candidates, and expect to continue the
same, we may not be able to achieve one or more of the foregoing timely or at all. As a
result, we could experience significant delays or inability in obtaining approval for our
product candidates, which would render us unable to achieve our milestones as planned
and materially harm our product development prospects.
Adverse events or undesirable side effects in clinical trials could interrupt, delay 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.
Adverse events in clinical trials could cause us or regulatory authorities to
interrupt, delay or halt clinical trials and result in a more restrictive label or the delay or
denial of regulatory approval. Results of our clinical trials could reveal a high and
unacceptable seriousness or prevalence of adverse events. In such event, our clinical trials
could be suspended or terminated, and regulatory authority could order us to cease
development of, or deny approval of, our product candidates for any or all targeted
diseases. Adverse events related to our product candidates could affect subject
recruitment or the ability of enrolled subjects to complete the trial and result in potential
product liability claims. Additionally, if any of our product candidates receives regulatory
approval, and we or others later identify undesirable adverse events caused by such
product, potentially significant negative consequences could result, including:
• regulatory authorities could interrupt, delay or halt pending clinical trials;
• we may suspend, delay or alter the development or marketing of our drug
candidates;
• regulatory authorities may order us to cease further development of, or deny
approval of, our drug candidates for any or all targeted indications if results
of our trials reveal a high and unacceptable severity or prevalence of certain
adverse events;
• regulatory authorities may delay or deny approval of our drug candidates;
• regulatory authorities may withdraw approvals or revoke licenses of an
approved drug candidate, or we may determine to do so even if not required;
• regulatory authorities may require additional warnings on the label of, or
impose other limitations on, an approved drug candidate;
• we may be required to develop a risk evaluation mitigation strategy for the
drug candidate, or, if one is already in place, to enhance such strategy, or to
develop a similar strategy as required by a comparable regulatory authority;
• we may be required to conduct post-market studies;
• we could be subject to litigation proceedings and held liable for harm caused
to patients exposed to or taking our drug candidates;
• the patient enrollment may be insufficient or slower than we anticipate or
patients may drop out or fail to return for post-treatment follow-up at a higher
rate than anticipated; and
• the costs of clinical trials of our drug candidates may be substantially higher
than anticipated.
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 our product
pipeline on research programs and drug candidates that we identify for selected
indications. For 2024 and 2025, we incurred R&D expenses for our Core Product MT1013
of RMB66.7 million and RMB84.4 million, respectively, representing 62.3% and 64.9% of
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our total R&D expenses. As a result, we may forgo or delay pursuit of opportunities with
other drug candidates or for other indications that may later prove to have greater
commercial potential or a greater likelihood of success.
Our spending on current and future R&D programs and drug candidates for specific
indications may not yield any commercially viable products. If we cannot accurately
evaluate the commercial potential or target market for a particular drug candidate, we
may relinquish valuable rights to that drug candidate through collaboration, licensing or
other royalty arrangements in cases in which 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 collaboration arrangement.
Clinical drug development involves a lengthy and expensive process with uncertain
outcomes, and results of earlier studies and trials may not be predictive of future trial
results.
Research programs to discover new drug candidates, develop new formulations or
pursue the development of our drug candidates for additional indications require
substantial technical, financial and human resources. Clinical testing is expensive and can
take years to complete, and its outcome is inherently uncertain. Failure can occur at any
time during the clinical trial process. The results of pre-clinical studies and early clinical
trials of our drug candidates may not be predictive of the results of later-stage clinical
trials, and initial or interim results of a trial may not be predictive of the final results. Drug
candidates in later stages of clinical trials may fail to show the desired safety and efficacy
traits. In some instances, there can be significant variability in safety and/or efficacy
results between different trials of the same drug candidate due to numerous factors,
including changes in trial procedures, differences in the size and type of the patient
populations, including genetic differences, patient adherence to the dosing regimen, other
trial protocol elements and the rate of dropout among clinical trial participants.
Moreover, a number of factors could affect clinical results including the different
patient enrollment standards adopted in different trials, dose regimen, and the other
aspects of clinical trial design. For our trials, results may differ from earlier trials due to
the larger number of clinical trial sites and additional countries and languages involved in
such trials. A number of pharmaceutical companies have suffered significant setbacks in
advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding
positive results in earlier trials. Our future clinical trial results may thus not be favorable,
which may materially and adversely affect our business, results of operations and
prospects.
Negative results from off-label use of our products could materially and adversely
affect our business, reputation, brand and results of operations, and could expose us to
liability.
The peptide drug market in the PRC has experienced accelerated growth due to
favorable government policies, increasing treatment demand and technological
advancements. The market has grown from RMB58.9 billion in 2020 to RMB70.0 billion in
2025, and is estimated to reach RMB174.2 billion by 2030. Peptide-based therapeutic
products include GLP-1 receptor agonists, gonadotropin-releasing hormone (GnRH)
agonists and other peptide-derived therapies, which are widely used in the treatment of
diabetes and obesity, oncology, endocrine disorders, cardiovascular diseases,
gastrointestinal diseases and infectious diseases.
As the peptide drug market continues to expand and peptide-based therapeutic
products become increasingly popular and widely adopted, physician and patient
awareness of such therapies may continue to increase. Coupled with their potential
applicability across multiple therapeutic areas and patient populations, including
metabolic diseases, cardiovascular diseases, tumors and immune-related disorders,
peptide-based therapeutic products may be particularly vulnerable to off-label use, which
refers to prescribing a product for an indication, dosage or in a dosage form that is not in
accordance with regulatory approved usage and labeling.
There is a risk that our drug candidates, upon regulatory approval for certain
indications, may be subject to off-label drug use with indications, dosages or dosage forms
not approved by relevant authorities, and the occurrence of such off-label use could
render our drug candidates less effective or entirely ineffective for those indications, or
cause unexpected adverse events, particularly if used at inappropriate dosage levels. To
the extent our products are used outside their approved indications and in turn result in
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adverse patient outcomes, such incidents may create negative publicity and significantly
harm our business reputation, product brand name, commercialization efforts and
financial condition. These occurrences may also expose us to liability arising from
off-label use of our drug candidates upon regulatory approval, which may subsequently
cause, or lead to, delays in our ongoing or planned clinical trials and may also ultimately
result in failure to obtain or maintain regulatory approval.
If we encounter difficulties or delays in enrolling suitable subjects in our clinical trials,
our clinical development activities could be delayed or otherwise adversely affected.
The timely completion of clinical trials depends, among other things, on our ability
to enroll a sufficient number of patients who remain in the trial until its conclusion. We
may experience difficulties in patient enrollment in trials for a variety of reasons. For
example, patient eligibility criteria defined in the protocols could be strict and it might
increase the chances that we are not able to recruit and retain suitable patients for our
clinical trials. Our clinical trials may compete with other clinical trials for drug candidates
that are in the same therapeutic areas.
We may not be able to identify or discover new drug candidates, or to identify
additional therapeutic opportunities for our drug candidates.
The success of our business depends in part upon our ability to identify or discover
additional drug candidates. There can be no assurance that we will be successful in
identifying new drug candidates in the future. We have also pursued, and may continue to
pursue, collaboration with third parties in the discovery and development of potential
drug candidates, including through co-development and licensing arrangements.
We work with CROs and other collaboration partners to develop our drug candidates. If
these third parties fail to duly perform their contractual obligations or meet expected
timelines, we may be unable to obtain regulatory approvals for, or commercialize, our
drug candidates.
We have worked with and plan to continue to work with third-party CROs to
execute our pre-clinical studies and clinical trials, and control only certain aspects of their
activities. Nevertheless, we are responsible for ensuring that each of our studies is
conducted in accordance with the applicable protocols, legal and regulatory requirements
and scientific standards, and our collaboration with the CROs does not relieve us of our
regulatory responsibilities. If we or any of our CROs or clinical investigators fail to
comply with applicable GCP , the clinical data generated in our clinical trials may be
deemed unreliable and the NMPA, the FDA, or comparable regulatory authorities may
require us to perform additional clinical trials before approving our marketing
applications. In addition, our registrational clinical trials must be conducted with product
produced under GMP regulations.
Our collaboration plays an important role in the R&D of our drug candidates. While
we generally seek to establish and maintain productive relationships, there can be no
assurance that all CROs will perform as expected. If any of our relationships with these
CROs terminate, we may not be able to enter into arrangements with alternative CROs or
to do so on commercially reasonable terms or timely. In addition, our CROs are not our
employees, and except for remedies available to us under our agreements with such
CROs, we cannot control whether or not they devote sufficient time and resources to our
ongoing clinical and non-clinical programs. If CROs do not carry out their contractual
duties or obligations or meet expected deadlines, or if they need to be replaced or if the
quality or accuracy of the clinical data they or our clinical investigators obtain is
compromised due to failure to adhere to our clinical protocols, regulatory requirements or
for other reasons, our clinical trials may be extended, delayed or terminated and we may
not be able to obtain regulatory approval for or successfully commercialize our drug
candidates. If our CROs err in their experimental operations, the development projects of
our drug candidates may be delayed or adversely affected. Switching or adding
additional CROs involves additional cost and delays, which can materially influence our
ability to meet our desired clinical development timelines. If any of the foregoing events
occurs, our results of operations and the commercial prospects for our drug candidates
would be adversely affected.
If we cannot maintain or develop clinical collaborations and relationships with our
principal investigators, key opinion leaders, physicians and experts, our results of
operations and prospects could be adversely affected.
Our relationships with principal investigators (“PIs”), KOLs, physicians and
experts play an important role in our R&D and marketing activities. However, we cannot
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assure you that we will be able to maintain or strengthen our clinical collaborations and
relationships with our PIs, KOLs, physicians and experts, or that our efforts to maintain or
strengthen such relationships will yield the successful development and marketing of new
products. These industry participants may leave their roles, change their business or
practice focus, choose to no longer cooperate with us or cooperate with our competitors
instead. If we are unable to develop new drugs or generate returns from our relationships
with industry participants as anticipated, or at all, our business, financial condition and
results of operations may be materially and adversely affected.
We have little experience in manufacturing biopharmaceutical products on a large
commercial scale and our business could be materially and adversely affected if we
encounter problems in manufacturing our future drug products.
As of the Latest Practicable Date, we had not established any manufacturing facility
for clinical and commercialization scale. We currently outsource the production of our
drug candidates to CDMOs. We have no experience in large-scale manufacturing of our
drug products for commercial use. Anticipating future commercialization, we plan to
continue to engage third-party CDMOs to manufacture our approved drug products. We
may in the future establish our own manufacturing facilities to support our development
and commercialization.
If we construct manufacturing facilities in the future, any delays in construction,
regulatory review or approval could limit our ability to produce sufficient quantities of
our product candidates, if approved, and thereby limit our development and
commercialization activities and our opportunities for growth. Cost overruns associated
with constructing or maintaining our facilities could require us to raise additional funds.
Our future manufacturing facilities may be subject to ongoing, periodic inspection
by the NMPA or other comparable regulatory agencies to ensure compliance with GMP .
Our failure to follow and document our adherence to GMP regulations or other regulatory
requirements may lead to significant delays in the availability of products for clinical or,
in the future, commercial use; and result in the termination of or a hold on a clinical trial;
or delay or prevent filing or approval of marketing applications for our product
candidates or the commercialization of our products, if approved. Meanwhile, our future
manufacturing facilities will need to comply with cGMP regulations and may be subject to
unannounced inspections and ongoing periodic inspections. If our future manufacturing
facilities or the equipment is damaged or destroyed, we may not be able to quickly or
inexpensively replace our manufacturing capacity or replace it at all.
Manufacturing methods and formulation are sometimes altered through the
development of drug candidates from clinical trials to approval, and further to
commercialization, in an effort to optimize manufacturing processes and results. Such
changes carry the risk that they will not achieve these intended objectives. Any of these
changes could cause the drug products to perform differently and affect the results of
planned clinical trials or other future clinical trials conducted with the altered materials.
This could delay the commercialization of drug products and require bridging studies or
the repetition of clinical trials, which may increases clinical trial costs, delay drug
approvals and jeopardize our ability to commence product sales and generate revenue.
We may also encounter problems with achieving adequate or clinical-grade
products that meet the standards or specifications of the NMPA, the FDA, or other
comparable regulatory agencies, and maintaining consistent and acceptable production
costs. We may experience shortages of qualified personnel, raw materials or key
contractors, and experience unexpected damage to our facilities or the equipment. In
these cases, we may be required to delay or suspend our manufacturing activities. We may
be unable to secure temporary, alternative manufacturers for our drugs with the terms,
quality and costs acceptable to us, or at all. Such an event could delay our clinical trials
and/or the availability of our drugs for commercial sales. Moreover, we may spend
significant time and costs to rectify these deficiencies before we can continue production.
We may not be able to maintain effective quality control over our drug products.
The quality of our products, including drug manufactured or to be manufactured by
our CDMO partner and drugs to be manufactured by us for commercial use in the future,
depends 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 quality of manufacturing staff and related training
programs and our ability to ensure that manufacturing employees adhere to our quality
control and quality assurance protocol. However, we cannot assure you that our quality
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control and quality assurance procedures will be effective in consistently preventing and
resolving deviations from our quality standards. Any significant failure or deterioration
of our quality control and quality assurance protocol could render our products
unsuitable for use, jeopardize any GMP certifications we may have and/or harm our
market reputation and relationship with business partners. Any such event may have a
material adverse effect on our business, financial condition and results of operations.
Our operations are dependent on the supply of certain raw materials. If the supply of
raw materials decreases or the cost increases, our ability to conduct our business could
be materially impaired.
During the Track Record Period, we relied on third parties to supply certain
materials. We expect to continue to rely on third parties to supply such materials and
equipment for the research, development, manufacturing and commercialization of our
drug products. For details, please refer to the paragraphs headed “Business — Suppliers
and Procurement” in this prospectus. There is a risk that, if supplies are interrupted, we
may not be able to find alternative supplies in a timely and commercially reasonable
manner, or at all, and it would materially harm our business.
Moreover, we require a stable supply of materials for our drug candidates in the
course of our R&D activities, and such needs increase significantly as we enter commercial
production of our products, but there is no assurance that current suppliers have the
capacity to meet our demand. Any delay in receiving such materials in the quantity and
quality that we need could delay the completion of our clinical studies, regulatory
approval of our drug candidates or our ability to timely meet market demand for our
commercialized products, as applicable. Our suppliers may not be able to cater to our
growing demands or may reduce or cease their supply of materials to us at any time.
We are also exposed to the risk of increased costs, which we may not be able to pass
on to customers and, as a result, lower our profitability. In the event of significant price
increases for materials, we cannot assure you that we will be able to raise the prices of our
future drug products sufficiently to cover the increased costs. As a result, any significant
price increase for materials may have an adverse effect on our profitability.
Additionally, our suppliers may also fail to maintain adequate quality of the
services, materials and equipment we need. We cannot assure you that we will be able to
identify all of the quality issues. Suboptimal or even deficient supplies of services,
materials and equipment may hinder the R&D of our drug candidates and the
commercial-scale manufacturing of our approved products, subject us to product liability
claims or otherwise have a material adverse effect on our operations.
In addition, we cannot assure you that these third parties will maintain and renew
all licenses, permits and approvals necessary for their operations or comply with all
applicable laws and regulations. Their failure to do so may lead to interruption in their
business operations, which in turn may result in shortage of materials and equipment
supplied to us, and cause delays in clinical trials and regulatory filings, or recall of our
products. The non-compliance of third parties may also subject us to potential product
liability claims, cause us to fail to comply with regulatory requirements, and incur
significant costs to rectify such non-compliance, which may have a material adverse effect
on our business, financial condition and results of operations.
We have limited experience in launching and marketing drug products. If we are unable
to effectively leverage third-party sales networks or build up or manage our in-house
commercialization team as we expected, or if we otherwise fail to effectively
commercialize our drugs after obtaining the regulatory approval, our business,
financial condition, results of operations and prospects may be materially and
adversely affected.
We have not yet demonstrated an ability to launch and commercialize any of our
drug products since our inception. The commercialization process involves numerous
complex stages, including but not limited to regulatory approvals, quality control and
scaled production, development of distribution channels, pricing strategy formulation,
market and customer education, brand building and marketing. Failure by our
management team to effectively coordinate and navigate these stages could result in
significant delays in product launch, cost overruns, suboptimal market acceptance,
regulatory or certification setbacks, loss of market share to competitors, and
lower-than-expected profit margins. Any of these factors could materially impede our
ability to achieve anticipated revenue and profitability targets and may have a material
adverse effect on our financial condition, cash flows, and returns to investors.
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We are preparing for the potential commercialization of our Core Product and other
drug candidates, which may involve building sales and marketing capabilities and
working with third parties such as CSOs. See “Business — Commercialization” for more
information. Such commercialization requires significant expenditures, management
resources and time. We may not be able to implement our commercialization strategies
successfully. We will have to continuously compete with other pharmaceutical companies
to recruit, hire, train and retain marketing and sales personnel. Additionally, there can be
no assurance that we will be able to establish or maintain stable and reliable collaborative
arrangements with third parties. 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 if our
collaborating third parties do not perform as expected.
Our drug candidates may fail to achieve or maintain the degree of market acceptance,
and the actual scale of sales of our product candidates may be smaller than anticipated,
which could render some product candidates unprofitable even if commercialized.
The degree of market acceptance of our drug products, if approved for commercial
sale, will depend on a number of factors, including, but not limited to: the clinical
indications for which our drug products are approved; physicians, hospitals, medical
treatment centers and patients considering our drug products as a safe and effective
treatment; the potential and perceived advantages of our drug products over alternative
treatments; the prevalence and severity of any side effects; product labelling or package
insert requirements of regulatory authorities; limitations or warnings contained in the
labelling approved by regulatory authorities; the timing of market introduction of our
drug products as well as competitive drugs; the cost of treatment in relation to alternative
treatments; the availability of adequate coverage and reimbursement under the NRDL, the
PRDL and other government-sponsored medical insurance programs in the PRC or other
jurisdictions worldwide, or from third-party payers such as commercial insurers; price
control or downward adjustment by the government authorities or other pricing pressure,
including the pricing constraints due to potential inclusion in the NRDL; the willingness
of patients to pay out-of-pocket in the absence of coverage and reimbursement by
third-party payers such as commercial insurers and government authorities; relative
convenience and ease of administration, including as compared to alternative treatments
and competitive therapies; adverse publicity about our products or favorable publicity
about competitive products; and the effectiveness of our sales and marketing efforts. Our
failure to achieve or maintain market acceptance for our future approved drug candidates
would materially adversely affect our business, financial condition, results of operations
and prospects.
The total addressable market opportunity will depend on, among other things,
acceptance of the product by the medical community and patient access, product pricing
and reimbursement. Moreover, the number of patients in the addressable markets may
turn out to be lower than expected, patients may not be amenable to treatment with our
products, or new patients may become increasingly difficult to identify or access. Further,
new studies may change the estimated incidence or prevalence of the diseases that our
product candidates target. Any of the above unfavorable developments could have a
material adverse effect on our business, financial condition and results of operations. For
details of the market size of the metabolic disease drug, antithrombotic drug and
neurological disease drug markets, please refer to the section headed “Industry
Overview” in this prospectus.
Guidelines, recommendations, and studies published by various organizations could
disfavor our approved drugs and drug candidates.
Government agencies, professional societies, practice management groups, private
health and science foundations and organizations focused on various diseases may
publish guidelines, recommendations or studies that affect our or our competitors’ drugs
and drug candidates. Any such guidelines, recommendations or studies that reflect
negatively on our drug products, either directly or indirectly relative to our competitive
drug products, could result in current or potential decreased use of, sales of, and revenue
from one or more of our drug products. Furthermore, our success depends in part on our
ability to educate healthcare providers and patients about our drug products, and these
education efforts could be rendered ineffective by, among other things, third-parties’
guidelines, recommendations or studies. As a result, our business, reputation, financial
condition and results of operations could be adversely affected.
If our products are not included in or are removed from national, provincial or other
government sponsored medical insurance programs, our business, financial condition,
results of operations and prospects could be materially and adversely affected.
The successful commercialization of our drugs when approved depends in part on
the extent to which reimbursement for these drugs and related treatments will be
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available from relevant health administrative authorities, private health insurers and
other organizations. In China, the National Reimbursement Drug List (“NRDL”) (ᔼ
ͦ፽) and Provincial Reimbursement Drug Lists (“PRDL”) (ͦ፽)
include drugs under the National Medical Insurance Catalogue, which affect the amounts
reimbursable to program participants for those drugs. There can be no assurance that any
of our drug products will be included in the NRDL or the PRDL after approval for
commercial sale. Innovative drugs similar to our drug products have historically been
more limited on their inclusion in the NRDL or the PRDL due to cost constraints. If we
were to successfully launch commercial sales of our products but fail in our efforts to have
our products included in the NRDL or the PRDL, our revenue from commercial sales will
be highly dependent on patient self-payment and payment from third parties such as
commercial insurers, which can make our products less competitive.
Government authorities and third-party payers, such as private health insurers and
healthcare organizations, decide which medications they will pay for and stipulate
reimbursement levels. With the trend of cost containment in the global healthcare
industry, government authorities and third-party payers have attempted to control costs
by limiting coverage and the amount of reimbursement for particular medications.
Obtaining reimbursement for our drugs may be particularly difficult because of the higher
prices often associated with drugs administered under the supervision of a doctor. If
reimbursement is not available or is available only to limited levels, we may not be able to
successfully commercialize MT1013 or any drug candidate that we have developed.
There may be significant delays in obtaining reimbursement for approved drug
candidates, and coverage may be more limited than the indications and purposes for
which the drug candidates are approved 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 use of the drug and the clinical setting in which it is used, may be based on payments
allowed for drugs with lower cost that have been covered in reimbursement policies, and
may be incorporated into existing payments for other services. Our inability to promptly
obtain coverage and profitable payment rates from both government-funded and private
payers for any future approved drug candidates and any new drugs that we develop could
have a material adverse effect on our business, financial condition, results of operations
and prospects.
The target market for CKD-SHPT may be limited, which may restrict the commercial
potential of our Core Product.
Clinically, CKD is classified into stages 1 to 5 based on GFR levels. In stage 1, renal
function is basically normal; stage 5 is end-stage renal disease, where patients need to rely
on dialysis or renal transplantation to sustain life. CKD-SHPT is particularly common in
patients with CKD in middle and advanced stages.
Our Company aims to get marketing approval for MT1013 for indication of stage 5
CKD complicated with CKD-SHPT. We are currently expanding indications to treat CKD
not on dialysis and CKD-MBD with Osteoporosis. According to Frost & Sullivan, the
global population of patients with Stage 5 CKD complicated by SHPT expanded from 5.0
million in 2020 to 5.9 million in 2025. This cohort is projected to reach 6.9 million by 2030
and 8.1 million by 2035. Concurrently, the patient population in China grew from 0.60
million in 2020 to 0.65 million in 2025, and is forecasted to hit 0.69 million by 2030 and 0.73
million by 2035.
A limited target market size may restrict our ability to achieve significant
commercial sales, and there can be no assurance that our Core Product will achieve
sufficient market acceptance or generate meaningful revenue. If the addressable patient
population is smaller than expected, our business, financial condition and results of
operations may be materially and adversely affected.
We may experience difficulties in our sales efforts as a result of pricing regulations or
other policies that are intended to reduce healthcare costs, which could subject us to
pricing and volume pressures and adversely affect our business, financial condition
and results of operations.
The regulations that govern regulatory approvals, pricing and reimbursement for
new therapeutic products vary widely from country to country. Some countries require
approvals of the sale price of a drug before marketing. In some markets, prescription
pharmaceutical pricing remains subject to continuing governmental control even after
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initial approvals are granted. As a result, we might obtain regulatory approvals for a drug
in a particular country, but then be subject to price regulations that delay our commercial
launch of the drug and negatively impact the revenue we are able to generate from the sale
of the drug in that country. Adverse pricing limitations may hinder our ability to recoup
our investment in one or more drug candidates.
It is typical that the prices of pharmaceutical products will decline over the life of
the products as a result of, among other things, the centralized tender process,
government pricing regulation, or increased competition from substitute products. The
importation of competing products from countries where government price controls or
other market dynamics result in lower prices may also exert downward pressure on the
prices of pharmaceutical products.
Prices of our products, if approved, may be susceptible to pricing pressure coming
from competing products. In addition, the relevant government authorities may change
the schemes of pricing control and statutory tender processes for pharmaceutical products
or revise other policies affecting prices of pharmaceutical products. Any development of
policies could create uncertainties materially and adversely affecting our product pricing,
and accordingly, our revenue and profitability.
If the prices of our products decline due to government pricing regulation, pricing
constraints due to potential inclusion in the NRDL, emergence of substitute products or
other market factors, we may not be able to mitigate the adverse effects of such price
reduction without incurring substantial expenses to improve our products, and our
business and profitability could be materially and adversely affected.
RISKS RELATING TO OUR INTELLECTUAL PROPERTY RIGHTS
If we are unable to obtain and maintain adequate intellectual property protection for
our product candidates throughout the world, or if the scope of such intellectual
property rights obtained is not sufficiently broad, third parties could compete directly
against us and our ability to successfully develop and commercialize any of our product
candidates would be materially and adversely affected.
Our success depends largely on our ability to protect our proprietary technology
and product candidates from competition by obtaining, maintaining and enforcing our
intellectual property rights, including patent rights. We seek to protect our technologies
and product candidates by, among others, filing patent applications in the PRC, and other
jurisdictions. However, applying for patent protection is expensive and time-consuming,
and we may not be able to successfully file and prosecute all necessary or desirable patent
applications at a reasonable cost or timely. We cannot assure you that our patent
application will be approved eventually. In addition, we may fail to identify patentable
aspects of our R&D output before it is too late to obtain patent protection.
Specifically, patents may be invalidated and patent applications may not be granted
not only because of known or unknown prior deficiencies in the patent applications, but
also due to the lack of novelty or inventiveness of the underlying invention or technology.
Parties who have access to confidential or patentable aspects of our R&D output may
breach our agreements and disclose such output before a patent application is filed,
jeopardizing our ability to seek patent protection.
In addition, under the PRC patent law, any organization or individual that applies
for a patent in a foreign country for an invention or utility model accomplished in China is
required to report to the CNIPA, for confidentiality examination. Otherwise, if such
application is later filed in China, the patent right will not be granted. Any of the
foregoing could have a material adverse effect on our competitive position, business,
financial condition, results of operations and prospects.
Our current or any future patent applications may not be successful and any patent
rights we or our licensing partners have may be challenged and invalidated even after
issuance, which would materially adversely affect our ability to successfully
commercialize any product or technology.
Our current and future patent applications may not result in the issuance of patents
at all, and even if were granted patents, they may not be issued in a form, or with a scope
of claims, that will provide us with any meaningful protection, prevent competitors or
other third parties from competing with us. In addition, the coverage claimed in a patent
application can be significantly reduced before the patent is issued, and changes in either
the patent laws or interpretation of the patent laws in China and other jurisdictions may
diminish the value of our patent rights or narrow the scope of our patent protection. Our
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patents may be challenged, narrowed, circumvented or invalidated by third parties, and
the product candidates relating to such patents could also be adversely affected. If any of
our patents are determined to constitute research achievements or service inventions of
our employees while working at third parties, including academic institutions, or involve
violations of non-compete obligations, they could adversely affect our patent rights and
operations. We cannot predict whether the patent applications we or our licensing
partners are currently pursuing and may pursue in the future will successfully result in
the issuance of any patents in any particular jurisdiction or whether the claims of any
issued patents will provide sufficient protection from competitors or other third parties.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or
enforceability, and our patent rights may be challenged in the courts or patent offices in
China and other jurisdictions. For example, if we or one of our licensors were to initiate
legal proceedings against a third party to enforce a patent covering one of our product
candidates, the defendant could counterclaim that our patent is invalid or unenforceable.
Grounds for a validity challenge could be an alleged failure to meet statutory
requirements, including lack of novelty, obviousness, lack of sufficient description or
non-enablement. Grounds for an unenforceability assertion could be an allegation that
someone connected with prosecution of the patent withheld material information from the
relevant patent office, or made a misleading statement, during prosecution. Third parties
may also raise similar patent invalidity claims before administrative bodies in China or in
other jurisdictions. Such mechanisms include invalidation, revocation. The outcome
following legal assertions of invalidity and unenforceability is unpredictable. Such
proceedings could result in revocation of or amendment to our patents in such a way that
they no longer adequately cover and protect our product candidates.
Obtaining and maintaining our patent protection depends on compliance with various
procedural, document submissions, fee payment and other requirements imposed by
governmental patent agencies, 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 CNIPA, the
United States Patent and Trademark Office (the “USPTO”) and other governmental patent
agencies in several stages over the lifetime of a patent. The CNIPA, USPTO and various
other governmental patent agencies require compliance with a number of procedural,
documentary, fee payment and other similar provisions during the patent application and
maintenance process. We are also dependent on our licensors to take the necessary action
to comply with these requirements with respect to our licensed intellectual property.
There are situations in which non-compliance can result in abandonment or lapse of the
patent or patent application, resulting in partial or complete loss of patent rights in the
relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of
a patent or patent application include failure to respond to official actions within
prescribed time limits, non-payment of fees and failure to properly legalize and submit
formal documents. In any such event, our competitors might be able to enter the market,
which would have a material adverse effect on our business.
We may become involved in lawsuits to protect or enforce our intellectual property or
being sued for infringing, misappropriating or other violating the intellectual property
rights of third parties, which could be expensive, time-consuming and unsuccessful.
Our commercial success depends upon our ability to develop, manufacture, market
and sell our drug candidates without infringing, misappropriating or otherwise violating
the intellectual property rights of others. The pharmaceutical industry is characterized by
extensive litigation regarding patents and other intellectual property rights. We or our
collaboration partners may be subject to claims that former employees, collaboration
partners or other third parties have an interest in our owned patents or other intellectual
property. 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. Additionally, pending patent applications which have been published can,
subject to certain limitations, be later amended in a manner that could cover our products
or their use.
Third parties might 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, use or manufacture of the compounds we have developed or are developing.
Such third parties might resort to litigation against us or other parties we have agreed to
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indemnify, which litigation could be based on either existing intellectual property or
intellectual property that arises in the future.
Parties making infringement, misappropriation, or other intellectual property
claims against us may obtain injunctive or other equitable relief, which could block our
ability to further develop and commercialize one or more of our drug candidates. Defense
of these claims, regardless of their merit, would involve substantial litigation expense and
would be a substantial diversion of management and employee resources from our
business. In addition, there is no assurance that a court would find in our favor on
questions of validity, enforceability, priority, or non-infringement. A court of competent
jurisdiction could hold that such third party patents are valid, enforceable, and infringed,
which could materially and adversely affect our ability to commercialize any of our
products or technologies covered by the asserted third-party patents.
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. Ultimately,
we could be prevented from commercializing future approved drugs, or be forced, by
court order or otherwise, to 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, including
treble damages and attorneys’ fees if we are found to willfully infringe a third party’s
patent. Defending against claims of patent infringement, misappropriation of trade
secrets or other violations of intellectual property rights could be costly and
time-consuming, regardless of the outcome.
If our trademarks and trade names are not adequately protected, then we may not be
able to build name recognition in our markets of interest and our business may be
adversely affected.
As of the Latest Practicable Date, we had 32 registered trademarks in the PRC and
six registered trademarks overseas, any of which may be the subject of a governmental or
third-party objection, which could prevent the registration or maintenance of the same.
We cannot assure you that any currently pending trademark applications or any
trademark applications we may file in the future will be approved. During trademark
registration proceedings, we may receive rejections and may be unable to overcome such
rejections. In addition, in proceedings before the CNIPA, the USPTO or comparable
agencies in many foreign jurisdictions, third parties are given an opportunity to oppose
pending trademark applications and to seek to cancel registered trademarks. Opposition
or cancellation proceedings may be filed against our trademarks and our trademarks may
not survive such proceedings. If we are unsuccessful in obtaining trademark protection
for our primary brands, we may be required to change our brand names, which could
materially and adversely affect our business. Moreover, as our products mature, our
reliance on our trademarks to differentiate us from our competitors will increase, and as a
result, if we are unable to prevent third parties from adopting, registering or using
trademarks that infringe, dilute or otherwise violate our trademark rights, or engaging in
conduct that constitutes unfair competition, defamation or other violation of our rights,
our business could be materially and adversely affected.
If we are unable to protect the confidentiality of our trade secrets and other confidential
information, including unpatented know-how upon which we rely, our business and
competitive position will be harmed. We may be subject to claims that our employees,
consultants or advisers have wrongfully used or disclosed alleged trade secrets of their
former employers, and we may be subject to 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
secrets and confidential information, including unpatented know-how, technology and
other proprietary information, to maintain our competitive position and to protect our
drug candidates. We seek to protect our trade secrets and confidential information, in
part, by entering into non-disclosure and confidentiality agreements with parties that
have access to trade secrets or confidential information, such as our employees, corporate
collaborators, sponsored researchers, contract manufacturers, consultants, advisers and
other third parties. However, we may not be able to prevent the unauthorized disclosure
or use of our trade secrets and confidential information. Monitoring unauthorized uses
and disclosures is difficult and we do not know whether the steps we have taken to protect
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our proprietary technologies will be effective. Any of the parties with whom we enter into
confidentiality agreements may breach or violate such agreements, and we may not be
able to obtain adequate remedies for such breach or violation. As a result, we could lose
our trade secrets and third parties could use our trade secrets to compete with us.
Additionally, we cannot guarantee that we have entered into such agreements with each
party that may have or has had access to our trade secrets or proprietary technology and
processes. Enforcing a claim that a party illegally disclosed or misappropriated a trade
secret can be difficult, expensive and time-consuming, and the outcome is unpredictable.
In addition, some courts in China, the U.S. and other jurisdictions may be less willing or
unwilling to recognize certain information as trade secrets to be protected. 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 to compete with
us and our competitive position would be harmed.
Furthermore, many of our employees, consultants, and advisers, including our
senior management, may currently be, or were previously employed at other
pharmaceutical companies, including our competitors or potential competitors. Some of
them, including each member of our senior management, may have executed proprietary
rights, non-disclosure and non-competition agreements in connection with such previous
employment. We cannot assure you that our employees, consultants and advisors do not
use the proprietary information or know-how of others in their work for us, and we may
be subject to claims that we or these individuals have used or disclosed intellectual
property, including trade secrets or other proprietary information, of any such
individual’s current or former employer. We may be subject to threatened or pending
claims related to these matters or concerning the agreements with our senior management
in the future. If we fail in defending any such claims, in addition to paying monetary
damages, we may lose valuable intellectual property rights or be required to obtain
licenses to such intellectual property rights, which may not be available on commercially
reasonable terms or at all. An inability to incorporate such intellectual property rights
would materially and adversely affect our business and may prevent us from successfully
commercializing our drug candidates. In addition, we may lose personnel as a result of
such claims and any such litigation or the threat thereof may adversely affect our ability to
hire employees or contract with independent contractors. A loss of key personnel or their
work product could hamper or prevent our ability to commercialize our drug candidates
and technology, which would have a material adverse effect on our business, results of
operations, financial condition and prospects.
While we typically require our employees, consultants and contractors who may be
involved in the conception or 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. Furthermore, even when we obtain agreements assigning intellectual property
to us, 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 to determine the ownership of
what we regard as our intellectual property. Furthermore, individuals executing
agreements with us may have pre-existing or competing obligations to a third party, such
as an academic institution, and thus an agreement with us may be ineffective in perfecting
ownership of inventions developed by that individual. If we fail in prosecuting or
defending any such claims, in addition to paying monetary damages, we may lose
valuable intellectual property rights.
In addition, we may in the future be subject to claims by former employees,
consultants or other third parties asserting an ownership right in our owned or licensed
patents or patent applications. An adverse determination in any such submission or
proceeding may result in loss of exclusivity or freedom to operate or in patent claims
being narrowed, invalidated or held unenforceable, in whole or in part, which could limit
our ability to stop others from using or commercializing similar drug candidates or
technology, without payment to us, or could limit the duration of the patent protection
covering our drug candidates and technology. Such challenges may also result in our
inability to develop, manufacture or commercialize our drug candidates without
infringing third-party patent rights. In addition, if the breadth or strength of protection
provided by our owned or licensed patents and patent applications is threatened, it could
dissuade companies from collaborating with us to license, develop or commercialize
current or future drug candidates. Any of the foregoing could have a material adverse
effect on our competitive position, business, financial conditions, results of operations
and prospects.
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Changes in patent and other intellectual property laws of China, the U.S., or other
jurisdictions could diminish the value of patents in general, thereby impairing our
ability to protect our drug candidates and future drugs.
Obtaining and enforcing patents in the pharmaceutical and biopharmaceutical
industry involves technological and legal complexity and is costly, time consuming and
inherently uncertain. Changes in either the patent laws or their interpretation in China,
the U.S. or other jurisdictions may increase the uncertainties and costs surrounding the
prosecution of our patents, diminish our ability to protect our inventions, and, more
generally, affect the value of our intellectual property or narrow the scope of our patent
rights.
In China, the recent amendment to the PRC Patent Law, amended in October 2020
and implemented in June 2021, introduced patent term compensation mechanism for
eligible invention patents related to new drugs. The patents owned by third parties may
be extended, which may in turn affect our ability to commercialize our products (if
approved) without facing infringement risks. According to the PRC Patent Law, the patent
term compensation may not exceed five years, and the total effective term of the patent
after the new drug approved for marketing shall not exceed 14 years. If we are required to
delay commercialization for an extended period of time, technological advances may
develop and new products may be launched, which may in turn render our products
non-competitive. We cannot guarantee that any other changes to PRC intellectual
property related laws would not have a negative impact on our intellectual property
protection.
Under the America Invents Act, the AIA, enacted in 2011, the U.S. moved to First
Inventor To File system under which the first to make the claimed invention was entitled
to the patent. Assuming the other requirements for patentability are met, the first to file a
patent application is entitled to the patent. Publications of discoveries in the scientific
literatures often lag behind the actual discoveries, and patent applications in the U.S. and
other jurisdictions are typically not published until 18 months after filing, or in some cases
not at all. Therefore, we cannot be certain that we were the first to make the inventions
claimed in our patents or pending patent applications, or that we were the first to file for
patent protection of such inventions.
RISKS RELATING TO OUR OPERATIONS
We are a biotechnology company with a limited operating history, which may make it
difficult to evaluate our current business and predict our future performance.
Our business can be traced back to our establishment in 2007, and we shifted our
focus to the development of peptide drugs in 2011. To date, we have no product approved
for commercial sale and have not become profitable from product sales. Our limited
operating history, particularly in light of the evolving drug R&D industry in which we
operate, the inherent uncertainties in drug R&D, 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 evolving fields
as we seek to transition into a company capable of supporting commercial activities. If we
do not address these risks and difficulties successfully, our business will suffer.
Our future success depends on our ability to retain key executives and to attract, hire,
retain and motivate other qualified and highly skilled personnel.
Our future success is dependent on our ability to attract a significant number of
qualified employees and retain existing key employees. We are highly dependent on the
continued contributions of Dr. Wang and our senior management, as well as other key
clinical and scientific personnel. The loss of the services of any of our executive officers or
other key employees could materially harm our business.
Competition for qualified employees in the biopharmaceutical industry is intense
and the pool of qualified candidates is limited. Our need to significantly increase the
number of our qualified employees and retain key employees may cause us to materially
increase compensation-related costs, including share-based compensation. We may not be
able to retain experienced senior management or key clinical and scientific personnel in
the future. The departure of any key employees may disrupt our drug development
progress and have a material and adverse effect on our business, financial condition,
results of operations and prospects. Moreover, to the extent we hire personnel from
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competitors, we also may be subject to allegations that they have been improperly
solicited or divulged proprietary or other confidential information. In addition, our senior
management team has limited experience in running public companies, which will require
us to hire additional staff and incur additional costs and expenses. If we are unable to
retain and motivate our employees and attract qualified personnel for important
positions, we may be unable to manage our business effectively which could adversely
affect our business, financial condition and results of operations.
We may engage in acquisitions or strategic partnerships, which may increase our capital
requirements, cause dilution for our Shareholders, cause us to incur debt or assume
contingent liabilities and subject us to other risks.
From time to time, to pursue our growth strategy, we may evaluate various
acquisitions, joint ventures and strategic partnerships, including licensing or acquiring
complementary products, intellectual property rights, technologies or businesses. Any
completed, in-process or potential acquisition or strategic partnership may entail
numerous risks, including: increased operating expenses and cash requirements; the
assumption of additional indebtedness or contingent or unforeseen 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 other party to such a
transaction, including the prospects of that party and their existing drugs or drug
candidates and regulatory approvals; and 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.
We may become involved in lawsuits or other legal proceedings, which could adversely
affect our business, financial conditions, results of operations and reputation.
We may become subject, from time to time, to legal proceedings and claims that arise
in the ordinary course of business or pursuant to governmental or regulatory enforcement
activity. Litigation to which we become a party might result in substantial costs and divert
management’s attention and resources. Additionally, it is possible that our liabilities
could exceed our insurance coverage. A claim brought against us that is uninsured or
underinsured could result in unanticipated costs and could have a material and adverse
effect on our financial condition, results of operations or reputation.
We have limited insurance coverage, and any claims beyond our insurance coverage
may result in our incurring substantial costs and a diversion of resources.
We maintain insurance policies required under the PRC laws and regulations as well
as based on our assessment of our operational needs and industry practice. In line with
industry practice in the PRC, we have elected not to maintain certain types of insurance.
Our insurance coverage may be insufficient to cover any claims that we may have. Any
liability or damage to, or caused by, our facilities or our personnel beyond our insurance
coverage may result in substantial costs and a diversion of resources and may negatively
impact our drug development and overall operations.
Increased labor costs could slow our growth and affect our operations.
Our success depends in part upon our ability to attract, motivate and retain a
sufficient number of qualified employees, including management, technical, R&D, sales
and marketing, production, quality control and other personnel. We have implemented a
number of initiatives in an effort to attract, retain and motivate our qualified and
competent staff. There is no assurance that these measures will be effective or that supply
of skilled labor in local markets will be sufficient to fulfill our needs. Competition for
competent and skilled labor is intensive in the industry. Our failure to hire and retain
enough skilled employees could delay the anticipated pre-clinical studies or clinical trials
timeframe or receipt of regulatory approvals to commercialize our drug candidates, or
result in our expenses exceeding our initial budget. Any of the foregoing changes could
have a material adverse effect on our business, profitability and prospects.
As of the Latest Practicable Date, we had 145 full-time employees, all based in
China, where the average labor cost has been steadily increasing over the past years as a
result of inflation, government-mandated wage increases and other changes in labor laws
and local economics. For example, staff costs and welfare expenses of our management
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and administrative personnel increased from RMB11.2 million for 2024 to RMB14.7
million for 2025. In particular, further changes in the labor laws, rules and regulations
may be promulgated by the PRC government in the future and our operations may be
materially and adversely affected if such laws, rules or regulations impose additional
burden on the employers. The labor cost will continue to increase in the future which is in
line with the economic growth in China. Competition for employees would require us to
pay higher wages, which would result in higher labor costs.
Our business faces considerable risks from health epidemics, natural disasters, acts of
war, and terrorism, which have historically disrupted operations and could
significantly impact our financial stability and operational effectiveness in the future.
Our operations and business plans may be adversely affected by health epidemics,
natural disasters, acts of war, terrorism, and other force majeure events. Events such as
severe natural disasters, epidemics, or government responses to these crises could
materially harm both the economy and our operations. Our operations are also vulnerable
to floods, earthquakes, sandstorms, snowstorms, fires, droughts, resource shortages,
system malfunctions, technical problems, and the potential impacts of wars or terrorist
attacks. These disasters could result in loss of life, injury, destruction of assets, and
significant disruption to our business.
We may be unable to detect, deter and prevent all instances of fraud or other
misconduct committed by our employees, principal investigators, consultants and
commercial partners.
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. 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.
We are subject to risks associated with leasing space.
As of the Latest Practicable Date, we leased four properties for office and R&D uses
in China. As our leases expire, we may fail to obtain renewals, either on commercially
acceptable terms or at all, which could compel us to close such offices or manufacturing
facilities. 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. In addition, as of the Latest Practicable Date, we had not registered
two of our lease agreements for these properties with the PRC government authorities as
required by laws of the PRC. We may be ordered by the PRC government authorities to
rectify such non-compliance and, if such non-compliance is not rectified within a given
period of time, we may be subject to fines imposed by PRC government authorities for
lease agreements that has not been registered with the PRC government authorities.
Our reputation is important to our business success, and damage to our reputation may
adversely affect our business.
Any negative publicity concerning us, our affiliates, our Shareholders, our
beneficial owners, Directors, officers, employees and business partners, management, or
any involvement in, or potential exposure to, claims, disputes, litigation, arbitration,
governmental investigations, administrative proceedings, or penalties, could materially
and adversely affect our business, financial condition, results of operations, and
reputation. In addition, to the extent our Shareholders, Directors, officers, employees and
business partners were incompliant with any laws or regulations or became involved in
lawsuits, disputes, or other legal proceedings or became subject to administrative
measures, penalties or investigations by regulatory authorities, we may also suffer
negative publicity or harm to our reputation. Any negative publicity regarding our
industry could also affect our reputation and commercialization. In addition, any negative
publicity about us could adversely affect our ability to maintain our existing collaboration
arrangements or attract new collaboration partners, and we may not be able to diffuse
such negative publicity to the satisfaction of our investors. As a result, we may be required
to spend significant time and incur substantial costs to respond and protect our
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reputation, and we cannot assure you that we will be able to do so within a reasonable
period of time, or at all, in which case our business, results of operations, financial
condition and prospects may be materially and adversely affected.
We may be exposed to the risks associated with potential expansion into global
markets.
We plan to explore market opportunities overseas. However, such activities may
subject us to additional risks that may materially adversely affect our ability to attain or
achieve profitable operations, including but not limited to: efforts to enter into license and
collaboration arrangements with third parties may increase our expenses or divert our
management’s attention from the development of drug candidates; political and economic
instability as well as geopolitical tensions, including the threat of war or terrorist attacks;
differing regulatory requirements for drug approvals and marketing internationally;
difficulty of effective enforcement of contractual provisions in local jurisdictions; and
potentially reduced protection for intellectual property rights.
These and other risks may materially adversely affect our ability to attain or sustain
revenue and profits from international markets.
RISKS RELATING TO OUR FINANCIAL POSITION AND NEED FOR ADDITIONAL
CAPITAL
We may need to obtain additional financing to fund our expansion of R&D and our
operations, and we may not have access to sufficient funding.
During the Track Record Period, our Company invested a large amount of funds in
preclinical research, clinical trials and pre-launch preparations for drug candidates in our
product pipeline. For 2024 and 2025, our R&D expenses amounted to RMB107.0 million
and RMB130.1 million, respectively. In the future, our business operations and the
implementation of our strategies will require significant funding. For further information,
please refer to “Future Plans and Use of Proceeds” in this prospectus.
In addition, many aspects of our general business operations have on-going funding
requirements that may increase over time. While we expect that the implementation of our
strategies and business plans will require us to rely in part on external financing sources,
our ability to obtain additional capital on commercially reasonable terms is subject to a
variety of factors, many of which are outside of our control, including our future financial
condition, results of operations and cash flows, the global economic conditions, industry
and competitive conditions, interest rates, prevailing conditions in the credit markets and
government policies on lending. If we cannot do so successfully, our strategies and
business plans will not be carried out as currently contemplated.
We recorded net losses and net operating cash outflows historically. We may continue to
incur net losses and net operating cash outflows for the foreseeable future and may not
achieve or maintain profitability in the future.
Investment in biopharmaceuticals is highly unpredictable in terms of commercial
success. It entails substantial upfront capital expenditures and significant risk that a
product candidate will fail to gain regulatory approval or become commercially viable.
We incurred losses and net operating cash outflows in each period since our inception. For
2024 and 2025, we recorded a loss of RMB156.8 million and RMB184.9 million,
respectively. A majority of our loss has resulted from costs incurred for R&D programs. We
expect to continue to incur losses for the foreseeable future, and we expect these losses to
increase as we continue to expand our R&D activities for our product and product
candidates, as well as to enhance our sales and marketing efforts.
We recorded net cash used in operating activities of RMB107.7 million and
RMB137.1 million for 2024 and 2025, respectively. For details, please refer to “Financial
Information — Liquidity and Capital Resources — Cash Flows” in this prospectus.
Negative operating cash flow may require us to obtain additional financing to meet our
financing needs and obligations and support our expansion plans. We cannot assure you
that we will have sufficient cash from other sources to fund our operations. If we resort to
other financing activities, we will incur additional financing costs, and we cannot
guarantee that we will be able to obtain the financing on terms acceptable to us, or at all.
In the event that we are unable to generate sufficient cash flow from our operations or
otherwise obtain sufficient external funds to finance our business, our liquidity and
financial condition may be materially and adversely affected and we may not be able to
expand our business as expected.
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We recorded net liabilities and net current liabilities historically, which may expose us
to liquidity risk.
As of December 31, 2025, we recorded net liabilities of RMB959.9 million and net
current liabilities of RMB4.2 million. A net liabilities position can expose us to liquidity
and financial risks. This in turn could require us to seek financing from external sources
such as bank borrowings, which may not be available on terms favorably or commercially
reasonable to us, or at all. If we are unable to maintain adequate working capital or obtain
sufficient financings to meet our capital needs, we may be unable to continue our
operations according to our plan, default on our payment obligations and fail to meet our
capital expenditure requirements, which may have a material adverse effect on our
business, financial condition, results of operations and prospects.
Our ability to generate revenue from sales of drug products and become profitable
depends significantly on our success in a number of factors that affect the sales volume,
pricing levels and profit margins of such drug products, such as competition or change
in market environment.
Our ability to generate revenue and achieve profitability depends significantly on
our success in many factors, including but not limited to: (i) obtaining regulatory
approvals and marketing authorizations for drug candidates for which we complete
clinical studies; (ii) completing research regarding, and nonclinical and clinical
development of, our drug candidates; (iii) addressing any competing technological and
market developments; (iv) identifying, assessing, acquiring and/or developing new drug
candidates, intellectual property and technologies; (v) negotiating favorable terms in any
collaboration, licensing, or other arrangements into which we may enter; (vi) maintaining,
protecting, expanding and enforcing our portfolio of intellectual property rights,
including patents, trademarks, trade secrets, and know-how; and (vii) attracting, hiring,
and retaining qualified personnel.
We cannot guarantee that we will be able to obtain regulatory approvals for any of
our drug candidates in a timely manner, or at all. Substantial investments may be incurred
before and after we generate any revenue from product sales. We expect to continue
incurring significant costs associated with the manufacturing and the commercial launch
of the drug products. Moreover, our expenses could increase beyond expectations if we
are required by the NMPA, the FDA or other applicable authorities to perform studies in
addition to those that we currently anticipate.
Considering the potential approval to market our drug candidates in the future, our
revenue will depend on factors that affect the sales volume, pricing level or profitability of
such approved products. Factors that could adversely affect the sales volumes, pricing
levels and profitability of the products we sell include: exclusion from, or reduced
coverage under, the national, provincial or other government-sponsored medical
insurance programs, the impact of government pricing regulations, sales of substitute
products by competitors, interruptions in the supply of raw materials, increases in the cost
of raw materials, issues with product quality or side effects, intellectual property
infringements, adverse changes in our sales and distribution network, and unfavorable
policy, regulatory or enforcement changes. These factors, many of which are outside of our
control, could adversely affect our operations, revenue and profitability.
We are exposed to changes in the fair value of financial assets at fair value through
profit or loss (“FVTPL”) and valuation uncertainties.
As of December 31, 2024 and 2025, our financial assets at FVTPL were RMB54.6
million and RMB95.2 million, respectively. Our financial assets at FVTPL represent the
structured deposits we purchased from banks in the PRC. We may incur fair value loss
with respect to our financial assets in the future as such fair value could be subject to
factors out of our control such as the macroeconomic conditions. For details, please refer
to Notes 20 and 32 to the Accountants’ Report in Appendix I to this prospectus.
Share-based payment may cause shareholding dilution to our existing Shareholders
and have a negative effect on our financial performance.
We adopted employee incentive plans for the benefit of our employees (including
directors) and consultants to incentivize and reward the eligible persons who have
contributed to the success of our Company. See Note 28 of the Accountants’ Report in
Appendix I to this prospectus. During the Track Record Period, no share-based payment
expenses were recognized. To further incentivize our employees to contribute to us, we
may grant additional incentives in the future. Issuance of Shares with respect to such
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incentives may dilute the shareholding percentage of our existing Shareholders. Expenses
incurred with respect to such share-based payments may increase our operating expenses
and have a material and adverse effect on our financial performance.
The discontinuation of any government grants or preferential tax treatment currently
available to us may adversely affect our business, financial condition and results of
operations.
We recorded government grants of RMB0.8 million and RMB0.3 million for 2024 and
2025, respectively. We generally do not have the ability to influence local government
authorities in making these decisions. Local authorities may reduce or eliminate
incentives at any time. In addition, some of the government financial incentives are
granted on a project basis and subject to the satisfaction of certain conditions, including
compliance with the applicable financial incentive agreements and completion of specific
projects therein. We cannot guarantee that we will satisfy all conditions, the failure of
which may deprive us of the incentives and have an adverse effect on our business,
financial condition and results of operations.
RISKS RELATING TO GOVERNMENT REGULATIONS
All material aspects of the research, development, manufacturing and
commercialization of our drug candidates are key concerns of the supervisory
authorities and the related regulations are subject to change.
All jurisdictions in which we intend to develop and commercialize our drug
candidates and conduct other pharmaceutical-industry activities regulate these activities
in great depth and detail. Major markets in the world all strictly regulate the
pharmaceutical industry, and in doing so they employ broadly similar regulatory
strategies, including regulation of the development and approval, manufacturing,
marketing, sales and distribution of pharmaceutical products. However, there are
differences in the regulatory regimes that make for a more complex and costly regulatory
compliance burden for a company like us that plans to operate in these regions.
Moreover, the regulatory framework regarding the pharmaceutical industry is
continuing to develop, and we cannot guarantee that amendments to the laws and
regulations with regard to pharmaceutical industry would not adversely affect our
business and prospects. Any such amendments may result in increased compliance
difficulty and costs or cause delays in, or prevent the successful development or
commercialization of, our drug candidates and reduce the current benefits. Developments
in government regulations or in practices relating to the pharmaceutical industry such as
a relaxation in regulatory requirements or the introduction of simplified approval
procedures which would lower the entry barrier for potential competitors, or an increase
in regulatory requirements which may increase the difficulty for us to satisfy such
requirements, may have a material adverse impact on our business, financial condition,
results of operations and prospects.
Obtaining regulatory approvals for our drug candidates is lengthy, time-consuming
and inherently unpredictable, and we may remain subject to extensive post-approval
regulatory requirements.
Significant time, efforts and expenses are required to bring our drug candidates to
market in compliance with the regulatory process, and we cannot assure you that any of
our drug candidates will be approved for sale. The time required to obtain approvals from
the NMPA, the FDA and other comparable regulatory authorities is often unpredictable,
and depends on numerous factors, including the substantial discretion of the regulatory
authorities. Our drug candidates could fail to receive regulatory approval in a timely
manner for many reasons, including but not limited to: failure to begin or complete
clinical trials due to disagreements with regulatory authorities; failure to demonstrate
that a drug candidate is safe and effective or, it is safe, pure, and potent for its proposed
indication; failure of clinical trial results to meet the level of statistical significance
required for approval; data integrity issues related to our clinical trials; disagreement
with our interpretation of data from preclinical studies or clinical trials; failure to conduct
a clinical trial in accordance with regulatory requirements or our clinical trial protocols;
and clinical sites, investigators or other participants in our clinical trials deviating from a
trial protocol, failing to conduct the trial in accordance with regulatory requirements, or
dropping out of a trial.
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In addition, the NMPA, the FDA or a comparable regulatory authority may require
more information, including additional analyses, reports, data, non-clinical studies and
clinical trials, or questions regarding interpretations of data and results, to support
approval, which may prolong, delay or prevent approval and our commercialization
plans, or we may decide to abandon the development programs. Changes in regulatory
requirements and guidance may also occur, and we may need to amend clinical trial
protocols submitted to competent regulatory authorities to reflect these changes.
Resubmission may impact the costs, timing or successful completion of a clinical trial. The
policies of the NMPA, the FDA and other comparable regulatory authorities may also
change, and additional government regulations may be enacted that could prevent, limit
or delay regulatory approval of our drug candidates. If we are slow or unable to adapt to
changes in existing requirements or the adoption of new requirements or policies, or if we
fail to maintain regulatory compliance, we may not obtain the regulatory approvals or
may lose the approvals that obtained and we may not achieve or sustain profitability.
Additionally, clinical trials conducted in one country may not be accepted by
regulatory authorities in other countries, and regulatory approval in one country does not
mean that regulatory approval will be obtained in any other country. Approval
procedures vary among countries and can involve additional product testing and
validation and additional administrative review periods. Seeking regulatory approvals in
various jurisdictions could result in significant delays, difficulties and costs for us and
may require additional preclinical studies or clinical trials which would be costly and time
consuming. We cannot assure you that we will meet regulatory requirements of different
jurisdictions or that our drug candidates will be approved for sale in those jurisdictions.
If the NMPA, the FDA or a comparable regulatory authority approves any of our
drug candidates, the manufacturing processes, labeling, packaging, storage, distribution,
adverse event reporting, advertising, promotion, sampling, record-keeping and
post-marketing studies for the drug will be subject to extensive and ongoing or additional
regulatory requirements on pharmacovigilance. These requirements include submissions
of safety and other postmarketing information and reports, registration, random quality
control testing, adherence to any CMC, variations, continued compliance with GMPs,
cGMPs, GCPs, good storage practices (“GSPs”) and good vigilance practices (“GVPs”)
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 the conditions of approval, or contain requirements for potentially costly
post-marketing 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 a comparable
regulatory authority 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. If any of the foregoing occurs with
respect to our drug candidates, it may result in, among other things: restrictions on the
marketing or manufacturing of our drugs, withdrawal of the product from the market, or
voluntary or mandatory product recalls; fines, warning letters, or holds on clinical trials;
refusal by the NMPA, the FDA or other comparable regulatory authorities to approve
pending applications or supplements to approved applications filed by us or suspension
or revocation of license approvals; product seizure or detention, or refusal to permit the
import or export of our drug candidates; and injunctions or the imposition of civil,
administrative or criminal penalties.
We may face risks arising from IT system failures and cybersecurity breaches, any of
which may require significant resources and may adversely affect our business,
operations and financial performance.
Our information technology systems and those of our business partners 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 R&D 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.
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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 data in the
jurisdictions in which we may 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.
Our operations are subject to extensive and evolving anti-kickback, anti-bribery, false
claims, physician payment transparency, fraud and abuse, and other healthcare-related
laws and regulations in multiple jurisdictions, and changes in the interpretation,
enforcement or application of such laws and regulations may adversely affect our
business, reputation, financial condition and results of operations.
Healthcare providers, physicians and others play a primary role in the
recommendation and prescription of any products for which we obtain regulatory
approval. Our operations are subject to various applicable anti-kickback, false claims
laws, physician payment transparency laws, fraud and abuse laws or similar healthcare
and security laws and regulations in China and the United States. Violations of fraud and
abuse laws may be punishable by criminal and/or civil sanctions, including penalties,
fines and/or exclusion or suspension from governmental healthcare programs and
debarment from contracting with governments.
There is no definitive guidance on the applicability of fraud and abuse laws to our
business. Law enforcement authorities are increasingly focused on enforcing these laws,
and the interpretation and application of such laws may evolve over time. As a result, our
business arrangements with third parties may be subject to regulatory scrutiny or
challenge. Efforts to ensure that our business arrangements with third parties comply
with applicable healthcare laws and regulations will involve substantial costs. If
regulatory authorities determine that any of our practices are not in compliance with
applicable laws and regulations, we may be subject to civil, criminal and administrative
penalties, damages, disgorgement, monetary fines, possible exclusion from participation
in governmental healthcare programs, contractual damages, reputational harm,
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 significant impact on
our business and results of operations.
In addition, 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 any other improper advantage.
Moreover, we are subject to the Foreign Corrupt Practices Act (the “FCPA”). The FCPA
generally prohibits us from making improper payments to non-U.S. officials for the
purpose of obtaining or retaining business. Non-compliance with anti-bribery laws may
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. Other
remedial measures could include further changes or enhancements to our procedures,
policies, and controls and potential personnel changes and/or disciplinary actions, any of
which could have a material adverse effect on our business, financial condition, results of
operations and liquidity. We could also be adversely affected by any allegation that we
violated such laws.
RISKS RELATING TO CONDUCTING BUSINESS IN THE JURISDICTION WHERE
WE MAINLY OPERATE
The pharmaceutical industry in the jurisdiction where we mainly operate is highly
regulated and such regulations are subject to change which may affect approval and
commercialization of our drugs.
We currently conduct most of our operations in China. The pharmaceutical industry
in China is subject to comprehensive government regulation and supervision,
encompassing the approval, registration, manufacturing, packaging, licensing and
marketing of new drugs. Any changes or amendments regulations, that alter our
Company’s original mode of operation, may result in increased compliance costs on our
business or cause delays in or prevent the successful development or commercialization of
our drug candidates in China and reduce the benefits.
We may face risks of having to transfer our scientific data.
On March 17, 2018, the General Office of the State Council promulgated the
Measures for the Management of Scientific Data (), or the Scientific
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Data Measures, which provided a broad definition of scientific data and rules for the
management of scientific data. According to the Scientific Data Measures, if the provision
of scientific data involving ‘‘state secrets’’ is required in foreign exchanges and
cooperation, Chinese enterprises should clarify the type, scope and purpose of the data to
be used, and report to the competent authority for approval in accordance with relevant
procedures of confidentiality management regulations. When publishing a paper in a
foreign academic journal requires the author to submit the relevant scientific data, the
author should, prior to the publication, submit such scientific data to the belonged
institution for unified management if such scientific data is generated with the
government funding. Given the term ‘‘state secret’’ is not clearly defined, we cannot
assure you that we can always obtain approvals for sending scientific data in the future,
such as the results of our preclinical studies or clinical trials conducted within the PRC,
abroad or to our foreign partners in the PRC. If we are unable to obtain necessary
approvals timely, or at all, our R&D of drug candidates may be hindered, which could
materially and adversely affect our business, financial condition, results of operations and
prospects. If the relevant government authorities consider the transmission of our
scientific data to be in violation of the Scientific Data Measures, we may be subject to
rectification and other administrative penalties imposed by those government authorities.
Investors of our H Shares may be subject to PRC income tax obligations.
Under the PRC Enterprise Income Tax Law ( ) and its
implementation regulations, dividends paid by a PRC resident enterprise, such as our
Company, to non-PRC resident enterprise investors are subject to a 10% withholding tax,
unless a lower treaty rate applies. Pursuant to the PRC Individual Income Tax Law,
dividends paid by a PRC company to non-PRC resident individual investors are subject to
a 20% withholding tax. This rate may be reduced under an applicable tax treaty. To
simplify tax administration for shares listed in Hong Kong, a withholding tax rate of 10%
is generally applied to dividends paid to non-PRC resident individual investors. There
remain uncertainties as to whether gains realized by non-PRC resident investors upon the
sale or other disposition of our H Shares would be considered income derived from
sources within the PRC and thus be subject to PRC income tax. If such gains are subject to
PRC income tax, the applicable rate for non-resident enterprises would generally be 10%,
and for non-resident individuals could be 20%, subject to any relief under applicable tax
treaties. If you are a non-PRC resident investor, you should consult your own tax adviser
regarding the tax implications of investing in our H Shares.
Governmental supervision of currency conversion, and restrictions on the remittance of
Renminbi into and out of China, may adversely affect the value of your investment.
Renminbi is currently not a fully freely convertible currency. The PRC government
imposes supervision on the convertibility of Renminbi into foreign currencies and, in
certain cases, the supervision of currency out of China. A portion of our revenue may be
converted into other currencies in order to meet our foreign currency obligations, e.g., to
obtain foreign currency to make payments of declared dividends, if any, on our H Shares.
Under China’s existing laws and regulations on foreign exchange, following the
completion of the Global Offering, we will be able to make dividend payments in foreign
currencies by complying with certain procedural requirements and without prior
approval from the State Administration of Foreign Exchange. However, in the future, the
PRC government may, at its discretion, take measures to restrict access to foreign
currencies for capital account and current account transactions under certain
circumstances. As a result, we may not be able to pay dividends in foreign currencies to
holders of our H Shares.
Fluctuations in exchange rates could result in foreign currency exchange losses.
All of our costs are denominated in Renminbi and our financial assets are
denominated in Renminbi and U.S. dollars. However, our proceeds from the Global
Offering will be denominated in Hong Kong dollars. The value of the Renminbi against
U.S. dollars and Hong Kong dollars, may fluctuate and is affected by, among other things,
changes in global political and economic conditions, which are out of our control.
Therefore, any fluctuations in the exchange rate of the Renminbi against other currencies
may expose us to exchange rate risks, and our results of operations may be adversely
affected. In addition, we normally do not have a foreign currency hedging policy and our
use of derivatives markets or foreign exchange hedging measures to minimize foreign
exchange rate risk may fail. Accordingly, we are exposed to exchange rate fluctuations and
such exposure may adversely affect our financial position and the performance of our
business.
RISK FACTORS
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There might be uncertainties in effecting service of legal process, enforcing foreign
judgments against us or our Directors and senior management personnel in the PRC.
We are incorporated under the laws of China, and substantially all of our assets are
located in China. In addition, a majority of our Directors and senior management
personnel reside within the PRC, with the majority of their assets located within the PRC.
Therefore, it may be difficult for investors to effect service of process upon us or our
Directors and senior management personnel in the PRC.
The approval, filing or other requirements of the CSRC or other PRC government
authorities may be required under PRC laws.
On February 17, 2023, the CSRC promulgated the Trial Measures and five related
guidelines, which became effective on March 31, 2023. The Trial Measures
comprehensively improve and reform the existing regulatory regime for overseas offering
and listing of PRC domestic companies’ securities and regulate both direct and indirect
overseas offering and listing of PRC domestic companies’ securities through a
filing-based regulatory regime.
Pursuant to the Trial Measures, PRC domestic companies that seek to offer and list
securities in overseas markets, either through direct or indirect means, are required to go
through the filing procedure with the CSRC and report relevant information. Where an
issuer submits an application for initial public offering to competent overseas regulators,
such issuer must file with the CSRC within three business days after such application is
submitted.
We cannot assure you that we could meet such requirements, complete such filing in
a timely manner. Any failure may restrict our ability to complete the proposed listing or
any future equity capital raising activities, which would have a material adverse effect on
our business and financial positions.
Changes in international trade policies and rising 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. China’s
political relationships with foreign countries and regions may affect the prospects of our
relationships 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
flow and prospects. Rising trade and political tensions could reduce levels of trade,
investments, technological exchanges and other economic activities between China and
other countries and regions, which would have an adverse effect on global economic
conditions, the stability of global financial markets, and international trade policies.
RISKS RELATING TO THE GLOBAL OFFERING
Any possible conversion of our Domestic Shares into H Shares in the future could
increase the supply of our H Shares in the market and may negatively impact the market
price of our H Shares.
Subject to the approval of the CSRC, all of our Domestic Shares may be converted
into H Shares in the future, and such converted Shares may be listed or traded on an
overseas stock exchange, provided that prior to the conversion and trading of such
converted Shares any requisite internal approval by our Shareholders and approval from
relevant PRC regulatory authorities shall have been obtained. However, the PRC
Company Law provides that in relation to the public offering of a company, the shares of
that company which are issued prior to the public offering shall not be transferred within
one year from the date of the listing. Therefore, upon obtaining the requisite approval, our
Domestic Shares may be traded, after the conversion, in the form of H Shares on the Stock
Exchange after one year of the Global Offering, which could further increase the supply of
our H Shares in the market and may negatively impact the market price of our H Shares.
RISK FACTORS
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No public market currently exists for our H Shares, and an active trading market for our
H Shares may not develop, especially considering that our existing Shareholders are
subject to a lock-up period.
No public market currently exists for our H Shares. The initial Offer Price for our H
Shares to the public will be the result of negotiations between our Company and the
Overall Coordinator (on behalf of the Underwriters) and the Offer Price may differ
significantly from the market price of the H Shares following the Global Offering. We have
applied for listing of and permission to deal in our Offer Shares on the Stock Exchange.
However, a listing on the Stock Exchange does not guarantee that an active and liquid
trading market for the H Shares will develop, or if it does develop, that it will be sustained
following the Global Offering, or that the market price of the H Shares will not decline
following the Global Offering. In particular, certain part of the H Shares in issue as of the
date of this prospectus will be subject to a lock-up period from the Listing Date, which
may significantly affect the liquidity and trade volume of the H Shares in the short term
following the Global Offering.
The price and trading volume of our H Shares may be volatile, which could lead to
substantial losses to investors.
The price and trading volume of our Shares may be subject to significant volatility
in response to various factors beyond our control, including the general market conditions
of the securities in Hong Kong and elsewhere in the world. In particular, the business and
performance and the market price of the shares of other companies engaging in similar
business may affect the price and trading volume of our Shares. In addition to market and
industry factors, the price and trading volume of our Shares may be highly volatile for
specific business reasons, such as the results of clinical trials of our drug candidates, the
results of our applications for regulatory approvals of our drug candidates, regulatory
developments affecting the pharmaceutical industry, healthcare, health, insurance and
other related matters, fluctuations in our revenue, earnings, cash flows, investments and
expenditures, relationships with our suppliers, movements or activities of key personnel,
and actions taken by competitors. Moreover, shares of other companies listed on the Stock
Exchange with significant operations and assets in China have experienced price volatility
in the past, and it is possible that our Shares may be subject to changes in price not directly
related to our performance.
Future sales or perceived sales of our H Shares in the public market by major
Shareholders following the Global Offering could materially and adversely affect the
price of our H Shares.
Prior to the Global Offering, there has not been a public market for our H Shares.
Future sales or perceived sales by our existing Shareholders of our H Shares after the
Global Offering could result in a significant decrease in the prevailing market price of our
H Shares. Only a limited number of the H Shares currently outstanding will be available
for sale or issuance immediately after the Global Offering due to contractual and
regulatory restrictions on disposal and new issuance. Nevertheless, after these restrictions
lapse or if they are waived, future sales of significant amounts of our H Shares in the
public market or the perception that these sales may occur could significantly decrease the
prevailing market price of our H Shares and our ability to raise equity capital in the future.
Payment of dividends is subject to restrictions under the PRC law and there is no
assurance whether and when we will pay dividends.
Under PRC law and regulations, we may only pay dividends out of distributable
profits. Distributable profits are our after-tax profits, less any recovery of accumulated
losses and appropriations to statutory and other reserves that we are required to make. As
a result, we may not have sufficient or any distributable profit to enable us to make
dividend distributions to our Shareholders, including in periods for which our financial
statements indicate we are profitable. Any distributable profit not distributed in a given
year is retained and available for distribution in subsequent years. The calculation of our
distributable profits under the PRC GAAP differs in many aspects from the calculation
under IFRS Accounting Standards. Moreover, our operating subsidiaries in China may not
have distributable profit as determined under the PRC GAAP . Accordingly, we may not
receive sufficient distributions from our subsidiaries for us to pay dividends. Failure by
our operating subsidiaries to pay us dividends could adversely impact our ability to make
dividend distributions to our Shareholders and our cash flow, including periods in which
we are profitable.
RISK FACTORS
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Raising additional capital may cause dilution to our Shareholders, restrict our
operations or require us to relinquish rights to our technologies or drug candidates.
We may finance our future cash needs through equity offerings, licensing
arrangements or other collaborations, government funding arrangements, debt
financings, or any combination thereof. In addition, we may seek additional capital due to
favorable market conditions or strategic considerations. To the extent that we raise
additional capital through the sale of equity or convertible debt securities, your
ownership interest will be diluted, and the terms may include liquidation or other
preferences that adversely affect your rights as a holder of our H Shares. The incurrence of
additional indebtedness or the issuance of certain equity securities could result in
increased fixed payment obligations and could also result in certain additional restrictive
covenants, such as limitations on our ability to incur additional debt or issue additional
equity, limitations on our ability to acquire or license intellectual property rights and
other operating restrictions that could adversely impact our ability to conduct our
business. In addition, issuance of additional equity securities, or the possibility of such
issuance, may cause the market price of our H Shares to decline.
Potential investors will experience immediate and substantial dilution as a result of the
Global Offering.
The Offer Price of the H Shares is higher than the net tangible asset value per H
Share immediately prior to the Global Offering. Therefore, purchasers of the H Shares in
the Global Offering will experience an immediate dilution. In order to expand our
business, we may consider offering and issuing additional Shares in the future. Purchasers
of the H Shares may experience dilution if we issue additional Shares in the future at a
price which is lower than the net tangible asset value per Share at that time. Furthermore,
we may issue Shares through the employee incentive platforms, which would further
dilute Shareholders’ interests in our Company.
We cannot make fundamental changes to our business without the consent of the Stock
Exchange.
On April 30, 2018, the Hong Kong Stock Exchange adopted rules under Chapter 18A
of Listing Rules. Under these rules, without the prior consent of the Stock Exchange, we
will not be able to effect any acquisition, disposal or other transaction or arrangement or a
series of acquisitions, disposals or other transactions or arrangements, which would result
in a fundamental change in our principal business activities as set forth in this prospectus.
As a result, we may be unable to take advantage of certain strategic transactions that we
might otherwise choose to pursue in the absence of Chapter 18A. Were any of our
competitors that are not listed on the Stock Exchange to take advantage of such
opportunities in our place, we may be placed at a competitive disadvantage, which could
have a material adverse effect on our business, financial condition and results of
operations.
Facts, forecasts and statistics in this prospectus relating to the pharmaceutical industry
are derived from various official government sources, which may not be accurate,
reliable, complete or up to date and have not been independently verified by us.
We have derived certain facts and other statistics in this prospectus, particularly the
section headed “Industry Overview,” from information provided by the PRC and other
government agencies. However, the information from official government sources has not
been independently verified by us, the Joint Sponsors, the Overall Coordinators, the
underwriters, any of their respective directors, employees, agents or advisors or any other
person or party involved in the Global Offering, and no representation is given as to its
accuracy.
Forward-looking statements contained in this prospectus are subject to risks and
uncertainties.
This prospectus contains certain future plans and forward-looking statements about
us that are made based on the information currently available to our management. The
forward-looking information contained in this prospectus is subject to certain risk and
uncertainties. Whether we implement those plans, or whether we can achieve the
objectives described in this prospectus, will depend on various factors including the
market conditions, our business prospects, actions by our competitors and the global
financial situations.
RISK FACTORS
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You should read the entire prospectus carefully, and we caution you not to place any
reliance on any information contained in press articles or other media regarding us or
the Global Offering.
Prior or subsequent to the publication of this prospectus, there may have been or be
press and media coverage regarding us and the Global Offering, which includes certain
information about us that does not appear in, or is different to what is contained in, this
prospectus. We have not authorized the disclosure of any such information in the press or
media. Financial information, financial projections, valuation and other information
about us contained in such unauthorized press or media coverage may not truly reflect
what is disclosed in the prospectus or the actual circumstances. We do not accept any
responsibility for such unauthorized press and media coverage or for the accuracy or
completeness of any such information. We make no representation as to the
appropriateness, accuracy, completeness or reliability of any such information. To the
extent that any information appearing in the press and media is inconsistent or conflicts
with the information contained in this prospectus, we disclaim it. Investors should rely
only on the information contained in this prospectus in making an investment decision.
RISK FACTORS
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In preparation for the Global Offering, we have sought the following waivers from
strict compliance with the relevant provisions of the Listing Rules and exemption from
strict compliance with the Companies (Winding Up and Miscellaneous Provisions)
Ordinance:
WAIVER IN RESPECT OF MANAGEMENT PRESENCE IN HONG KONG
Pursuant to Rule 8.12 of the Listing Rules, an issuer must have a sufficient
management presence in Hong Kong. This normally means that at least two of its
executive directors must be ordinarily resident in Hong Kong. Rule 19A.15 of the Listing
Rules further provides that the requirement in Rule 8.12 of the Listing Rules may be
waived by having regard to, among other considerations, the new applicant’s
arrangements for maintaining regular communication with the Stock Exchange, including
but not limited to compliance by the new applicant with Rules 3.06, 3A.23 and 3A.24 of the
Listing Rules.
Our Group’s daily operations and major assets are primarily located in the PRC, and
our Group’s management members are, and expect to continue to be, based primarily in
the PRC. Our Company considers that our Group’s management members are best able to
attend to its functions by being based in the PRC. Our Company’s executive Director is not
or will not be ordinarily resident in Hong Kong after the Listing of our Company. The
Directors consider that relocation of our Company’s executive Director to Hong Kong will
be burdensome and costly for our Company, and it may not be in the best interests of our
Company and its Shareholders as a whole to appoint additional executive Directors who
are ordinarily resident in Hong Kong. Furthermore, if the executive Director or the
additional ones are not able to be physically present at the location where our Group’s
daily operations take place, they may not be able to fully or promptly understand the
daily business operation of our Group nor appreciate the circumstances affecting the
business operations and development of our Group from time to time.
As such, our Company does not have, and for the foreseeable future will not have,
sufficient management presence in Hong Kong for the purpose of satisfying the
requirements under Rule 8.12 and Rule 19A.15 of the Listing Rules.
Accordingly, we have applied to the Stock Exchange for, and the Stock Exchange has
granted us, a waiver from strict compliance with Rule 8.12 and Rule 19A.15 of the Listing
Rules. Our Company has made the following arrangements to maintain effective
communication between the Stock Exchange and us:
(i) our Company has appointed and will continue to maintain Dr. Wang Bing ( ˮ
Ώ) and Ms. Chan Yee Lam (௓ၥᔝ) as its authorised representatives (the
“Authorised Representatives”) pursuant to Rules 3.05 and 3.06(2) of the
Listing Rules. The Authorised Representatives will act as our Company’s
principal communication channel with the Stock Exchange. Each of the
Authorised Representatives will be available to meet with the Stock Exchange
within a reasonable time frame upon the request of the Stock Exchange and
will be readily contactable by telephone, facsimile and email. Our Company
has provided the Stock Exchange with the contact details of the Authorised
Representatives and our Company will inform the Stock Exchange promptly
in respect of any change to the contact details of the Authorised
Representatives;
(ii) the Authorised Representatives have the means of contacting all Directors
(including the independent non-executive Directors) promptly at all times as
and when the Stock Exchange proposes to contact a Director with respect to
any matter. To enhance communication between the Stock Exchange and the
Authorised Representatives or the Directors, our Company will implement a
policy whereby (i) the executive Director will provide a valid phone number
or other means of communication for the Authorised Representatives when he
is traveling or out of office, and (ii) each Director will provide his or her
mobile phone number, office phone number, e-mail address and, where
available, fax number to the Stock Exchange and our Company will inform the
Stock Exchange promptly in respect of any changes to the contact details of
the Directors;
WAIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES AND
EXEMPTION FROM STRICT COMPLIANCE WITH THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
–5 5–


--- page 64 ---
(iii) all the Directors who are not ordinarily resident in Hong Kong have
confirmed that they possess or can apply for valid travel documents to visit
Hong Kong and will be able to meet with relevant members of the Stock
Exchange in Hong Kong upon reasonable notice, when required; and
(iv) Pursuant to Rule 3A.19 of the Listing Rules, we have retained the services of
Halcyon Capital Limited as Compliance Adviser upon Listing for a period
commencing on the Listing Date and ending on the date on which we comply
with Rule 13.46 of the Listing Rules in respect of our financial results for the
first full financial year commencing after the Listing Date. The Compliance
Adviser will have access at all times to the Authorised Representatives, our
Company’s Directors and senior management, who will act as the additional
channel of communication with the Stock Exchange when the Authorised
Representatives are not available. Our Company has provided the Stock
Exchange with the contact details of the Compliance Adviser and will inform
the Stock Exchange promptly in respect of any changes to the contact details
of the Compliance Adviser.
Our Company will inform the Stock Exchange as soon as practicable in respect of
any changes in the Authorised Representatives and/or the Compliance Adviser in
accordance with the Listing Rules.
WAIVER IN RESPECT OF APPOINTMENT OF JOINT COMPANY SECRETARIES
Pursuant to Rules 3.28 and 8.17 of the Listing Rules, the company secretary of an
issuer must be an individual who, by virtue of his or her academic or professional
qualifications or relevant experience, is, in the opinion of the Stock Exchange, capable of
discharging the functions of company secretary.
(i) a member of The Hong Kong Chartered Governance Institute (formerly
known as The Hong Kong Institute of Chartered Secretaries);
(ii) a solicitor or barrister as defined in the Legal Practitioners Ordinance
(Chapter 159 of the Laws of Hong Kong); and
(iii) a certified public accountant as defined in the Professional Accountants
Ordinance (Chapter 50 of the Laws of Hong Kong).
Note 2 to Rule 3.28 of the Listing Rules further sets out the factors that the Stock
Exchange will consider in assessing an individual’s “relevant experience”:
(i) length of employment with the issuer and other issuers and the roles he or she
played;
(ii) familiarity with the Listing Rules and other relevant laws and regulations
including the SFO, the Companies Ordinance, the Companies (Winding Up
and Miscellaneous Provisions) Ordinance and the Takeovers Code;
(iii) r elevant training taken and/or to be taken in addition to the minimum
requirement under Rule 3.29 of the Listing Rules; and
(iv) professional qualifications in other jurisdictions.
Pursuant to paragraph 13 of Chapter 3.10 of the Guide for New Listing Applicants,
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:
(i) whether the issuer has principal business activities primarily outside Hong
Kong;
(ii) 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 Guide for New Listing Applicants) nor Relevant
Experience (as defined under paragraph 11 of Chapter 3.10 of the Guide for
New Listing Applicants) as a company secretary; and
(iii) why the directors consider the individual to be suitable to act as the issuer’s
company secretary.
WAIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES AND
EXEMPTION FROM STRICT COMPLIANCE WITH THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
–5 6–


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Further, pursuant to paragraph 13 of Chapter 3.10 of the Guide for New Listing
Applicants, such waiver, if granted, will be for a fixed period of time (the “Waiver
Period”) and on the following conditions:
(i) 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
(ii) the waiver will be revoked if there are material breaches of the Listing Rules
by the issuer.
Our Company considers that while it is important for the company secretary to be
familiar with the relevant securities regulations in Hong Kong, he/she also needs to have
experience relevant to our Company’s operations, a nexus to our Board and a 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 is familiar
with our Company’s business and affairs as company secretary.
Our Company has appointed Ms. Chan Yee Lam ( ௓ၥᔝ ), as one of the joint
company secretaries.
We have applied to the Hong Kong 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 on the basis of the proposed arrangements below:
(i) Mr. Zou Ran ( ཅ್ ) will endeavor to attend relevant training courses,
including briefings on the latest changes to the relevant applicable Hong
Kong laws and regulations and the Listing Rules which will be organized by
our Company’s Hong Kong legal advisors on an invitation basis and seminars
organized by the Stock Exchange for listed issuers from time to time;
(ii) Mr. Zou Ran (ཅ್) has confirmed that he will be attending a total of no less
than 15 hours of training courses on the Listing Rules, corporate governance,
information disclosure, investors relation as well as the functions and duties
of the company secretary of a Hong Kong listed issuer during each financial
year as required under Rule 3.29 of the Listing Rules;
(iii) Ms. Chan Yee Lam ( ௓ၥᔝ) will assist Mr. Zou Ran ( ཅ್) to enable him to
acquire the relevant experience (as required under Rule 3.28 of the Listing
Rules) to discharge the duties and responsibilities as the company secretary of
our Company;
(iv) Ms. Chan Yee Lam ( ௓ၥᔝ) will communicate regularly with Mr. Zou Ran ( ཅ
್) on matters relating to corporate governance, the Listing Rules and any
other laws and regulations which are relevant to our Company and its affairs.
Ms. Chan Yee Lam (௓ၥᔝ) will work closely with, and provide assistance for,
Mr. Zou Ran (ཅ್) in the discharge of his duties as a company secretary,
including organizing our Company’s Board meetings and Shareholders’
general meetings;
(v) upon expiry of Mr. Zou Ran ( ཅ್)’s initial term of appointment as the
company secretary of our Company, our Company will evaluate his
experience in order to determine if he has acquired the qualifications required
under Rule 3.28 of the Listing Rules, and whether on-going assistance should
be arranged so that Mr. Zou Ran (ཅ್)’s appointment as the company
secretary of our Company continues to satisfy the requirements under Rules
3.28 and 8.17 of the Listing Rules. The waiver will be revoked immediately if
Ms. Chan Yee Lam (௓ၥᔝ) ceases to provide assistance to Mr. Zou Ran (ཅ್)
as a joint company secretary for the three-year period after the Listing or
where there are material breaches of the Listing Rules by our Company;
(vi) our Company has appointed Halcyon Capital Limited as the Compliance
Adviser pursuant to Rule 3A.19 of the Listing Rules which will act as the
additional communication channel with the Stock Exchange (for a period
commencing on the Listing Date and ending on the date on which our
WAIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES AND
EXEMPTION FROM STRICT COMPLIANCE WITH THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
–5 7–


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Company complies with Rule 13.46 of the Listing Rules in respect of its
financial results for the first full financial year after the date of listing, or until
the engagement is terminated, whichever is earlier). Halcyon Capital Limited
will provide professional guidance and advice to our Company as to the
compliance with the Listing Rules and all other applicable laws and
regulations; and
(vii) the waiver is valid for an initial three-year period commencing from the
Listing, and will be revoked immediately if Ms. Chan Yee Lam ( ௓ၥᔝ) ceases
to provide assistance and guidance to Mr. Zou Ran ( ཅ್), or if there are
material breaches of the Listing Rules by our Company. Prior to the expiry of
the initial three-year period, our Company will re-evaluate the qualifications
and experiences of Mr. Zou Ran ( ཅ್) and liaise with the Stock Exchange to
revisit the situation in the expectation that we should then be able to
demonstrate to the Stock Exchange’s satisfaction that Mr. Zou Ran ( ཅ್),
having had the benefit of assistance from Ms. Chan Yee Lam ( ௓ၥᔝ)’s for
three years, would then have acquired the relevant experience within the
meaning of Note 2 to Rule 3.28 of the Listing Rules such that a further waiver
would not be necessary.
EXEMPTION FROM STRICT COMPLIANCE WITH SECTION 342(1)(B) IN RELATION
TO PARAGRAPH 27 OF PART I AND PARAGRAPH 31 OF PART II OF THE THIRD
SCHEDULE TO THE COMPANIES (WINDING UP AND MISCELLANEOUS
PROVISIONS) ORDINANCE
Section 342(1)(b) of the Companies (Winding Up and Miscellaneous Provisions)
Ordinance requires all prospectuses to include matters specified in Part I of the Third
Schedule to the Companies (Winding Up and Miscellaneous Provisions) Ordinance, and
set out the reports specified in Part II of the Third Schedule to the Companies (Winding Up
and Miscellaneous Provisions) Ordinance.
Paragraph 27 of Part I of the Third Schedule to the Companies (Winding Up and
Miscellaneous Provisions) Ordinance requires a company to include in its prospectus a
statement as to the gross trading income or sales turnover (as the case may be) of the
company during each of the three financial years immediately preceding the issue of the
prospectus, including an explanation of the method used for the computation of such
income or turnover and a reasonable breakdown between the more important trading
activities.
Paragraph 31 of Part II of the Third Schedule to the Companies (Winding Up and
Miscellaneous Provisions) Ordinance further requires the company to include in its
prospectus a report by the auditors of the company with respect to profits and losses of the
company in respect of each of the three financial years immediately preceding the issue of
the prospectus and the assets and liabilities of the company of each of the three financial
years immediately preceding the issue of the prospectus.
Section 342A(1) of the Companies (Winding Up and Miscellaneous Provisions)
Ordinance provides that the SFC may issue, subject to such conditions (if any) as the SFC
thinks fit, a certificate of exemption from 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 compliance with any or all of such requirements
would be irrelevant or unduly burdensome, or would otherwise be unnecessary or
inappropriate.
Rule 18A.03(3) of the Listing Rules requires that an eligible biotech company must
have been in operation in its current line of business for at least two financial years prior
to listing under substantially the same management. Rule 18A.06 of the Listing Rules
requires that an eligible biotech company must comply with Rule 4.04 of the Listing Rules
modified so that references to “three financial years” or “three years” in Rule 4.04 shall
instead reference to “two financial years” or “two years”, as the case may be. Further,
pursuant to Rule 8.06 of the Listing Rules, the latest financial period reported on by the
reporting accountants for a new applicant must not have ended more than six months
from the date of the listing document.
WAIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES AND
EXEMPTION FROM STRICT COMPLIANCE WITH THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
–5 8–


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Accordingly, we applied to the SFC for, and the SFC has granted, a certificate of
exemption from strict compliance with section 342(1)(b) of the Companies (Winding Up
and Miscellaneous Provisions) Ordinance in relation to the requirements of paragraph 27
of Part I and paragraph 31 of Part II of the Third Schedule to the Companies (Winding Up
and Miscellaneous Provisions) Ordinance regarding the inclusion of the accountants’
report covering the full three financial years immediately preceding the issue of this
prospectus on the following grounds:
(i) our Company is a biotechnology company focusing on the field of
bi-/multi-Specific peptide drug development, and falls within the scope of a
biotech company as defined under Chapter 18A of the Listing Rules. Our
Company is seeking a listing under Chapter 18A and will fulfill the additional
conditions for listing required under Chapter 18A of the Listing Rules;
(ii) the Accountants’ Report of our Company for the two financial years ended
December 31, 2025 has been prepared and is set out in Appendix I to this
prospectus in accordance with Rule 18A.06 of the Listing Rules;
(iii) as of the Latest Practicable Date, our Company had developed a pipeline of
bi-/multi-functional peptides and innovative drug candidates, including: (i)
the Core Product, MT1013, the peptide drug targeting both CaSR and OGP
receptors, primarily developed for the treatment of CKD-SHPT, with the
potential to be further developed for additional indications such as
CKD-MBD with Osteoporosis and CKD-SHPT not on Dialysis; and (ii) three
Key Products, namely XTL6001, MT1002 and MT200605, as well as other
product candidates. Major financing activities conducted by our Company
since its incorporation include the Pre-IPO Investments, the details of which
have been fully disclosed in the paragraphs headed “History, Development
and Corporate Structure — Pre-IPO Investments” in this prospectus;
(iv) notwithstanding that the financial results set out in this prospectus are only
for the two financial years ended December 31, 2025 in accordance with
Chapter 18A of the Listing Rules, other information required to be disclosed
under the Listing Rules and the Companies (Winding Up and Miscellaneous
Provisions) Ordinance has been adequately disclosed in this prospectus
pursuant to the relevant requirements;
(v) 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 our Company. We did
not generate any revenue or incur any cost of sales during the Track Record
Period. For the years ended December 31, 2024 and 2025, we reported total
comprehensive losses of RMB156.83 million and RMB184.91 million,
respectively, which were primarily attributable to research and development
expenses, administrative expenses and finance costs. Our Company did not
record any revenue for the financial year ended December 31, 2023, and other
income in 2023 mainly came from bank interest income and government
grants. We believe the financial information for the financial year ended
December 31, 2023 does not provide meaningful insight into our future
performance and is not necessary for investors’ understanding and
assessment of the business, assets and liabilities, financial position,
management and prospects of the Group; and
WAIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES AND
EXEMPTION FROM STRICT COMPLIANCE WITH THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
–5 9–


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(vi) our Directors and the Joint Sponsors are of the view that the Accountants’
Report covering the two financial years ended December 31, 2025 (as set out in
Appendix I to this prospectus), together with other disclosures in this
prospectus, have already provided adequate and reasonable up-to-date
information for the potential investors to make an informed assessment of the
business, assets and liabilities, financial position, management and prospects
and 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 interest 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) the particulars of the exemption are set out in this prospectus; and (ii) this prospectus
will be issued on or before June 15, 2026.
CONSENT IN RESPECT OF CORNERSTONE INVESTMENT BY CLOSE ASSOCIATE
OF EXISTING SHAREHOLDERS
Paragraph 1C(2) of Appendix F1 to the Listing Rules (the “ Placing Guidelines ”)
provides, inter alia, that without the prior written consent of the Stock Exchange, 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 of the Listing Rules are fulfilled.
Chapter 2.3 of the Guide for New Listing Applicants provides that existing
shareholders and/or their close associates are allowed to participate in the initial public
offering of a Biotech Company (as defined under Chapter 18A of the Listing Rules)
provided that the applicant complies with Rules 8.08(1)/19A.13A and 8.08A/19A.13C of
the Listing Rules. Further, pursuant to paragraph 18 of Chapter 2.3 of the Guide, an
existing shareholder holding less than 10% of shares in a Biotech Company may subscribe
for shares in the proposed listing as either a cornerstone investor or as a placee and an
existing shareholder holding 10% or more of shares in a Biotech Company must subscribe
for shares in the proposed listing as a cornerstone investor.
Rule 19A.13A of the Listing Rules requires that, where a new applicant is a PRC
issuer with no other listed shares at the time of listing, at least a minimum prescribed
percentage of shares in the class to which H shares belong must be H shares held by the
public at the time of listing, determined by reference to the expected market value of the
class of shares to which H shares belong at the time of listing.
Rule 19A.13C of the Listing Rules further requires that, where a new applicant is a
PRC issuer with no other listed shares at the time of listing, the portion of H shares for
which listing is sought that are held by the public and not subject to any disposal
restrictions (whether under contract, the Listing Rules, applicable laws or otherwise), at
the time of listing, must: (a) represent at least 10% of the total number of issued shares in
the class to which H shares belong at the time of listing (excluding treasury shares), with
an expected market value at the time of listing of not less than HK$50,000,000; or (b) have
an expected market value at the time of listing of not less than HK$600,000,000.
Each of Junying Growth, Listing Reserve Fund, Junying Jiacheng, Xi’an Huiyu,
Shaanxi Innovation Relay, Shaanxi Jingang and New Materials Fund are ultimately
controlled by the People’s Government of Shaanxi Province (the “ Existing
Shareholders”). Qiyuan High-tech Innovation Investment (Hong Kong) Limited
(“Qiyuan Hong Kong”), one of our Cornerstone Investors, is also ultimately controlled by
Shaanxi Provincial SASAC and hence a close associate of one of our Existing Shareholders
(the “Proposed Cornerstone Investment ”). For further details, please refer to the section
headed “Cornerstone Investors” in this prospectus.
WAIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES AND
EXEMPTION FROM STRICT COMPLIANCE WITH THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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The Stock Exchange has granted the requested consent subject to the conditions
that:
(a) our Company will comply with the public float requirements of Rule 19A.13A
and the free float requirement under Rule 19A.13C of the Listing Rules. For
details of the calculation of public float and free float of the Company, please
refer to the section headed “History, Development and Corporate Structure”
in this prospectus;
(b) the Offer Shares to be subscribed by and allocated to Qiyuan Hong Kong as a
Cornerstone Investor under the Global Offering will be at the same Offer Price
and on substantially the same terms as the other Cornerstone Investor
(including being subject to a lock-up period of six months from the Listing
Date, and Qiyuan Hong Kong shall pay and settle in full the consideration for
the Offer Shares before the dealing commence on the Listing Date);
(c) no preference in allocation has been, nor will be, given to Qiyuan Hong Kong
other than the preferential treatment of assured entitlement at the Offer Price
under a cornerstone investment and the terms of the cornerstone investment
agreement of the Qiyuan Hong Kong are substantially the same as the other
cornerstone investment agreements following the principles set out in
Chapters 2.3 and 4.15 of the Guide and each of the Company, the Joint
Sponsors and the Overall Coordinators has provided the Stock Exchange with
written confirmations in accordance with Chapters 2.3 and 4.15 of the Guide
for New Listing Applicants; and
(d) details of the allocation of the Offer Shares to Qiyuan Hong Kong in the Global
Offering as a cornerstone investor 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 Proposed Cornerstone Investment, please refer to
the section headed “Cornerstone Investors” in this prospectus.
WAIVERS FROM STRICT COMPLIANCE WITH THE LISTING RULES AND
EXEMPTION FROM STRICT COMPLIANCE WITH THE COMPANIES
(WINDING UP AND MISCELLANEOUS PROVISIONS) ORDINANCE
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DIRECTORS’ RESPONSIBILITY FOR THE CONTENTS OF THIS PROSPECTUS
This prospectus, for which our Directors (including any proposed director who is
named as such in this prospectus) collectively and individually accept full responsibility,
includes particulars given in compliance with the Companies (Winding up and
Miscellaneous Provisions) Ordinance, the Securities and Futures (Stock Market Listing)
Rules (Chapter 571V of the Laws of Hong Kong) and the Listing Rules for the purpose of
giving information to the public with regard to us. Our Directors, having made all
reasonable enquiries, confirm that, to the best of their knowledge and belief, the
information contained in this prospectus is accurate and complete in all material respects
and not misleading or deceptive, and there are no other facts, the omission of which
would make this prospectus or any statement in this prospectus misleading.
CSRC FILING REQUIREMENT
We have filed the required documents with the CSRC, and the CSRC has issued the
filing notice dated March 27, 2026, confirming our completion of the filing pursuant to the
new filing regime introduced by the Overseas Listing Trial Measures for the Global
Offering, the conversion of certain Unlisted Shares into H Shares and the listing of the H
Shares on the Stock Exchange. The notice of filing only confirms the filing information of
our Company’s overseas offering and listing, and does not represent that the CSRC makes
any substantial judgment or guarantee about the investment value of our Company’s
securities or the proceeds of investors, nor does it indicate that the CSRC makes any
guarantee or affirmation about the authenticity, accuracy and completeness of this
prospectus.
UNDERWRITING
This prospectus is published solely in connection with the Hong Kong Public
Offering which forms part of the Global Offering. For applicants under the Hong Kong
Public Offering, this prospectus contain the terms and conditions of the Hong Kong Public
Offering.
The 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 and therein must
not be relied upon as having been authorized by our Company, the Joint Sponsors, the
Overall Coordinators, the Joint Global Coordinators, the Joint Bookrunners, the Joint Lead
Managers, any of the Underwriters or Capital Market Intermediaries, any of their
respective directors, agents, employees or advisors or any other party involved in the
Global Offering.
The listing of the Offer Shares on the Stock Exchange is sponsored by the Joint
Sponsors and the Global Offering is managed by the Overall Coordinators. Pursuant to the
Hong Kong Underwriting Agreement, the Hong Kong Public Offering is underwritten by
the Hong Kong Underwriters on a conditional basis, with one of the conditions being that
the Offer Price is agreed between the Overall Coordinators (for themselves and on behalf
of the Underwriters) and us. The International Offering is managed by the Overall
Coordinators and is underwritten by the International Underwriters. The International
Underwriting Agreement is expected to be entered into on or about the Price
Determination Date, subject to agreement on the Offer Price between our Company and
the Overall Coordinators (for themselves and on behalf of the Underwriters). If, for any
reason, the Offer Price is not agreed between our Company and the Overall Coordinators
(for themselves and on behalf of the Underwriters) on or before the Price Determination
Date, or such later date or time as may be agreed between the Overall Coordinators (for
themselves and on behalf of the Underwriters) and our Company, the Global Offering will
not proceed. See “Underwriting” for details about the Underwriters and the underwriting
arrangements.
Neither the delivery of this prospectus nor any offering, sale or delivery made in
connection with the Offer Shares should, under any circumstances, constitute a
representation that there has been no change or development reasonably likely to involve
a change in our affairs since the date of this prospectus or imply that the information
contained in this prospectus is correct as at any date subsequent to the date of this
prospectus.
DETERMINATION OF THE OFFER PRICE
The Offer Shares are being offered at the Offer Price which the Overall Coordinators
(for themselves and on behalf of the Underwriters) and our Company will determine on or
before Monday, June 22, 2026, and in any event not later than 12:00 noon on Monday, June
22, 2026.
INFORMATION ABOUT THIS PROSPECTUS AND THE GLOBAL OFFERING
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If, for any reason, the Overall Coordinators (for themselves and on behalf of the
Underwriters) and our Company are unable to reach an agreement on the Offer Price on or
before the Price Determination Date, or such later date or time as may be agreed between
the Overall Coordinators (for themselves and on behalf of the Underwriters) and our
Company, the Global Offering (including the Hong Kong Public Offering) will not become
unconditional and will lapse.
RESTRICTIONS ON OFFER AND SALE OF THE OFFER SHARES
No action has been taken to permit a Hong Kong Public Offering of the Offer Shares
or the general distribution of this prospectus in any jurisdiction other than Hong Kong.
Accordingly, this prospectus may not be used for the purposes of, and does not constitute,
an offer or invitation in any jurisdiction or in any circumstances in which such an offer or
invitation is not authorized or to any person to whom it is unlawful to make such an offer
or invitation. The distribution of this prospectus and the offering and sales of the Offer
Shares in other jurisdictions are subject to restrictions and may not be made except as
permitted under the applicable securities laws of such jurisdictions pursuant to
registration with or authorization by the relevant securities regulatory authorities or an
exemption therefrom. Each person acquiring the Hong Kong Offer Shares under the Hong
Kong Public Offering will be required to confirm, or be deemed by his or her acquisition of
Hong Kong Offer Shares to confirm, that he or she is aware of the restrictions on offers and
sales of the Offer Shares described in this prospectus. In particular, the Offer Shares have
not been offered or sold, and will not be offered or sold, directly or indirectly, in the PRC.
The Offer Shares are offered for subscription solely on the basis of the information
contained and representations made in this prospectus, and on the terms and subject to
the conditions set out herein and therein. No person is authorized in connection with the
Global Offering to give any information, or to make any representation not contained in
this prospectus, and any information or representation not contained in this prospectus
must not be relied upon as having been authorized by our Company, the Joint Sponsors,
the Overall Coordinators, the Joint Global Coordinators, the Joint Bookrunners, the
Underwriters, the Capital Market Intermediaries, any of their respective directors,
officers, employees, agents, affiliates or advisers or any other persons or parties involved
in the Global Offering. For further details of the structure of the Global Offering, including
its conditions, and the procedures for applying for Hong Kong Offer Shares, see
“Structure of the Global Offering” and “How to Apply for Hong Kong Offer Shares”.
APPLICATION FOR LISTING ON THE STOCK EXCHANGE
We have applied to the Listing Committee for the granting of the listing of, and
permission to deal in, our H Shares to be converted from the Unlisted Shares, our H Shares
to be issued pursuant to the Global Offering (including any H Shares which may be issued
pursuant to the Over-allotment Option). No part of our H Shares is listed on or dealt in on
any other stock exchange, and no such listing or permission to list is being or proposed to
be sought in the near future.
Under section 44B(1) of the Companies (Winding Up and Miscellaneous Provisions)
Ordinance, any allotments made in respect of any applications will be invalid if the listing
of, and permission to deal in, the Offer Shares on the 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.
COMMENCEMENT OF DEALINGS IN THE H SHARES
Dealings in the H Shares on the Stock Exchange are expected to commence on
Wednesday, June 24, 2026. The H Shares will be traded in board lots of 200 H Shares. The
stock code of the H Shares is 2335.
COMPLIANCE WITH LISTING RULES
We will comply with applicable laws and regulations in Hong Kong (including the
Listing Rules) and any other undertakings which have been given in favor of the Stock
Exchange from time to time. If the Listing Committee finds that there has been a breach by
us of the Listing Rules or such other undertakings which may have been given by us in
favor of the Stock Exchange from time to time, the Listing Committee may instigate
cancelation or disciplinary proceedings in accordance with the Listing Rules.
INFORMATION ABOUT THIS PROSPECTUS AND THE GLOBAL OFFERING
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H SHARE REGISTER OF MEMBERS AND STAMP DUTY
All H Shares issued pursuant to applications made in the Hong Kong Public
Offering and the International Offering will be registered on our Company’s H Share
register of members to be maintained by our H Share Registrar, Tricor Investor Services
Limited. We will maintain our Company’s principal register of members at our current
registered office in the PRC.
Dealings in the H Shares registered in our H Share register of members will be
subject to the Hong Kong stamp duty. See “Statutory and General Information — Taxation
of Holders of H Share” in Appendix IV to this prospectus. Investors should seek
professional tax advice for further details of Hong Kong stamp duty.
Unless otherwise determined by our Board, dividends will be paid to Shareholders
whose names are listed on our H Share register of members in Hong Kong, by ordinary
post, at the Shareholders’ risk in Hong Kong dollars to the registered address of each
Shareholder.
REGISTRATION OF SUBSCRIPTION, PURCHASE AND TRANSFER OF H SHARES
We have instructed our H Share Registrar, and our H Share Registrar has agreed, not
to register the subscription, purchase or transfer of any H Shares in the name of any
particular holder unless and until such holder delivers a signed form to our H Share
Registrar in respect of those H Shares bearing statements to the effect that the holders:
• agrees with us and each of our Shareholders, and we agree with each
Shareholder, to observe and comply with the PRC Company Law, the
Overseas Listing Trial Measures and our Articles of Association;
• agrees with us, each of our Shareholders, Directors, managers and officers,
and we, acting for ourselves and for each of our Directors, managers and
officers agree with each of our Shareholders, to refer all differences and claims
arising from our Articles of Association or any rights or obligations conferred
or imposed by the PRC Company Law or other relevant laws and
administrative regulations concerning our affairs to arbitration, and any
reference to arbitration shall be deemed to authorize the arbitration tribunal
to conduct hearings in open session and to publish its award, which
arbitration shall be final and conclusive;
• agrees with us and each of our Shareholders that the H Shares are freely
transferable by the holders thereof; and
• authorizes us to enter into a contract on his or her behalf with each of our
Directors, managers and officers whereby such Directors, managers and
officers undertake to observe and comply with their obligations to our
Shareholders as stipulated in our Articles of Association. Persons applying for
or purchasing H 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 Shareholder or a nominee of any
of the foregoing.
DIVIDENDS PA YABLE TO HOLDERS OF H SHARES
Unless determined otherwise by our Company, dividends payable in Hong Kong
dollars in respect of the H Shares will be paid to the Shareholders as recorded on the H
Share register of members of our Company in Hong Kong and sent by ordinary post, at the
Shareholders’ risk, to the registered address of each Shareholder.
According to the Guide to the Program for “Full Circulation” of H-shares of the
Shenzhen Branch of China Securities Depository and Clearing Corporation Limited
promulgated by the Shenzhen Branch of CSDC on September 20, 2024, cash dividends to
domestic investors of H-share “full circulation” shall be distributed through Shenzhen
Branch of CSDC. An H-share listed company shall transfer RMB cash dividends to the
designated bank account of the Shenzhen Branch of CSDC, who shall complete the
clearing of cash dividends by distributing the cash dividends to investors through
domestic securities companies.
INFORMATION ABOUT THIS PROSPECTUS AND THE GLOBAL OFFERING
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H SHARES WILL BE ELIGIBLE FOR ADMISSION INTO CCASS
Subject to the granting of listing of, and permission to deal in, the Offer Shares on
the Stock Exchange and our compliance with the stock admission requirements of HKSCC,
our H Shares will be accepted as eligible securities by HKSCC for deposit, clearance and
settlement in CCASS with effect from the date of commencement of dealings in our H
Shares on the Stock Exchange or any other date as determined by HKSCC. Settlement of
any 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. All necessary arrangements have been made for our H Shares to be admitted
into CCASS. Investors should seek the advice of their stockbroker or other professional
advisers for details of the settlement arrangements as such arrangements may affect their
rights and interests.
PROFESSIONAL TAX ADVICE RECOMMENDED
Applicants for the Offer Shares are recommended to consult their professional
advisers if they are in any doubt as to the tax implications of subscribing for, purchasing,
holding, disposing of and dealing in our H Shares or exercising rights attached to them.
None of our Company, the Underwriters, the Joint Sponsors, the Overall Coordinators, the
Joint Global Coordinators, the Joint Bookrunners, the Joint Lead Managers, the Capital
Market Intermediaries, any of their respective directors, supervisors, officers, employees,
agents or advisers or representatives or any other persons involved in the Global Offering
accepts responsibility for any tax effects on, or liabilities of, any holders of Shares
resulting from the subscription, purchase, holding or disposal of, or dealing in, our H
Shares or exercising any rights attached to them.
OVER-ALLOTMENT AND STABILIZATION
In connection with the Global Offering, the Stabilizing Manager (on behalf of the
International Underwriters) or any persons acting for it may over-allot shares or effect any
other transactions with a view to prevent a decline in the market price of our H Shares for
a limited period after the issue date. However, there is no obligation on the Stabilizing
Manager or any person acting for it to do this. Such stabilization action, if taken, may be
discontinued at any time and is required to end after a limited period. In Hong Kong and
certain other jurisdictions, activities aimed at reducing the market price are prohibited,
and the price at which stabilization is effected is not permitted to exceed the Offer Price.
In connection with the Global Offering, our Company intends to grant to the
International Underwriters the Over-allotment Option, exercisable by the Overall
Coordinators (on behalf of the International Underwriters) for up to 30 days after the last
day for the lodging of applications under the Hong Kong Public Offering. Pursuant to the
Over-allotment Option, our Company may be required to allot and issue at the Offer Price
up to an aggregate of 8,708,000 additional H Shares (representing not more than 15% of the
Offer Shares initially available under the Global Offering), in connection with
over-allocations in the Global Offering, if any.
See the section headed “Structure of the Global Offering” for further details with
respect to stabilization and the Over-allotment Option.
INFORMATION ON THE CONVERSION OF UNLISTED SHARES INTO H SHARES
Our Company has applied for conversion of Domestic Shares into H Shares, which
involves 222,016,700 Unlisted Shares (taking into account the Subdivision) held by the
existing Shareholders. See the sections headed “History, Development and Corporate
Structure” and “Share Capital” for details of our existing Shareholders and their
respective interests in our Company and relevant procedures for the conversion of
Unlisted Shares into H Shares. Such H Shares to be converted from Unlisted Shares are
restricted from trading for a period of one year after the Listing. The relevant filing
procedure in relation to the conversion of certain Unlisted Shares into H Shares has been
completed on March 27, 2026.
PROCEDURES FOR APPLICATION FOR HONG KONG OFFER SHARES
The procedures for applying for the Hong Kong Offer Shares are set out in the
section headed “How to Apply for Hong Kong Offer Shares.”
STRUCTURE OF THE GLOBAL OFFERING
See the section headed “Structure of the Global Offering” for details of the structure
of the Global Offering, including its conditions.
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,
this prospectus shall prevail. The English names of the PRC nationals, entities,
departments, facilities, certificates, titles, laws, regulations and the like are translations of
their Chinese names and are included herein for identification purposes only. If there is
any inconsistency, the Chinese name prevails.
ROUNDING
Certain amounts and percentage figures included in this prospectus have been
subject to rounding adjustments, or have been rounded to one or two decimal places. Any
discrepancies in any tables or charts between the total shown and the sums of the amounts
listed are due to rounding.
MARKET SHARE DATA
The statistical and market share information contained in this prospectus has been
derived from official government publications, market data providers and other
independent third-party sources. Unless otherwise indicated, the information has not
been verified by us independently. This statistical information may not be consistent with
other statistical information from other sources within or outside the PRC. While
reasonable caution has been made in the process of reproducing the data and statistics
extracted from such official government publications or other sources, the Joint Sponsors
and our Company, or any of their directors, employees, agents, and representatives make
no representation to the appropriateness, accuracy, completeness or reliability of any such
statistical and market share information.
EXCHANGE RATE CONVERSION
Solely for your convenience, certain translations among amounts in Renminbi, HK
dollars or US dollars are contained in this prospectus. None should be regarded as and be
interpreted as an amount in one currency that can be on the relevant dates or any other
dates actually converted into that in another currency at the rates below or cannot be
converted at all. Unless otherwise specified:
(i) all amounts in Renminbi are translated into HK dollars at an exchange rate of
RMB0.87 to HK$1.00, being the middle exchange rate set by the PBOC
prevailing on the Latest Practicable Date;
(ii) all amounts in Renminbi are translated into US dollars at an exchange rate of
RMB6.82 to US$1.00, being the middle exchange rate set by the PBOC
prevailing on the Latest Practicable Date; and
(iii) all amounts in HK dollars are translated into US dollars at an exchange rate of
HK$7.83 to US$1.00 (calculated based on (i) and (ii) above).
Any discrepancies in any table between totals and sums of amounts listed therein
are due to rounding.
INFORMATION ABOUT THIS PROSPECTUS AND THE GLOBAL OFFERING
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DIRECTORS
Name Address Nationality
Executive Directors
Wang Bing
(ˮΏ)
No. 2504, Unit 2, Building 5
North Area
Residential Area
Jiaotong Medical College
No. 239, Yanta West Road
Yanta District
Xi’an, Shaanxi Province
PRC
Chinese
Yu Weiping 6-7780 Bridge Street
Richmond
British Columbia
Canada
Canadian
Non-executive Directors
Wang Mei
(ˮૠ)
No. 2504, Unit 2, Building 5
North Area
Residential Area
Jiaotong Medical College
No. 239, Yanta West Road
Yanta District
Xi’an, Shaanxi Province
PRC
Chinese
You Xiangdong
(؇)
No. 2101, Unit 1, Building 7
Binjiang Jinse Jiayuan
Shangcheng District
Hangzhou, Zhejiang Province
PRC
Chinese
Song Gaoguang
(҂৷ᄿ)
No. 401, Unit 1, Building 4
Yujingyuan Residential Quarter
Yinghai Town
Daxing District
Beijing
PRC
Chinese
Wang Nayi
(❙)
Room F, 24th Floor, Building 2
Guozhong Apartment
Lane 20, Fuxin Road
Yangpu District
Shanghai
PRC
Chinese
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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Name Address Nationality
Independent Non-executive Directors
Xiangli Liuxu
(Ԣʬᚃ)
Room 1804, Building 33
Jiaoda Third Village
Beilin District
Xi’an, Shaanxi Province
PRC
Chinese
Zhang Wenqiang
(ੵ˖੶)
No. 1502, Unit 1, Building 3
Courtyard 2
Guomei First City
Qingnian Road
Chaoyang District
Beijing
PRC
Chinese
Wang Kaifeng
(ࢤ)
Flat 31H, Block 21
South Horizons
Aberdeen
No. 18 South Horizons Drive
Southern District
Hong Kong
Chinese
For further details, please refer to the section headed “Directors and Senior
Management” in this prospectus.
PARTIES INVOLVED
Joint Sponsors,
Overall Coordinators,
Sponsor-Overall
Coordinators, Joint Global
Coordinators, Joint
Bookrunners and
Joint Lead Managers
CCB International Capital Limited
12/F, CCB Tower
3 Connaught Road Central
Central
Hong Kong
China Merchants Securities (HK) Co., Limited
32/F, One Exchange Square
8 Connaught Place
Central
Hong Kong
Joint Bookrunners and
Joint Lead Managers
Jakota Securities Group Limited
Unit E, 24/F, Tai Yau Building
181 Johnston Road
Wanchai
Hong Kong
Ruibang Securities Limited
9/F, Sang Woo Building
227-228 Gloucester Road
Wanchai
Hong Kong
Sinolink Securities (Hong Kong) Company Limited
Unit 3501-08, 35/F Cosco Tower
183 Queen’s Road Central
Sheung Wan
Hong Kong
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
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Skyvast Securities Limited
FLAT 3304, 33/F, Bank of America Tower
12 Harcourt Road
Central
Hong Kong
Somerley Capital Limited
20/F China Building
29 Queen’s Road Central
Hong Kong
Tiger Brokers (HK) Global Limited
23/F, Li Po Chun Chambers
189 Des Voeux Road Central
Hong Kong
uSmart Securities Limited
Room 2602A, 26/F, Tower 1 Lippo Centre
89 Queensway
Admiralty
Hong Kong
Webull Securities Limited
Suites 2509-12, 25/F, Tower 6, The Gateway, Harbour
City
9 Canton Road
Hong Kong
Zhongtai International Securities Limited
19 Floor, Li Po Chun Chambers
189 Des Voeux Road Central
Hong Kong
ZMF Asset Management Limited
2502, World Wide House
19 Des Voeux Road Central
Hong Kong
Capital Market Intermediaries CCB International Capital Limited
12/F, CCB Tower
3 Connaught Road Central
Central
Hong Kong
China Merchants Securities (HK) Co., Limited
32/F, One Exchange Square
8 Connaught Place
Central
Hong Kong
Jakota Securities Group Limited
Unit E, 24/F, Tai Yau Building
181 Johnston Road
Wanchai
Hong Kong
Ruibang Securities Limited
9/F, Sang Woo Building
227-228 Gloucester Road
Wanchai
Hong Kong
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
–6 9–


--- page 78 ---
Sinolink Securities (Hong Kong) Company Limited
Unit 3501-08, 35/F Cosco Tower
183 Queen’s Road Central
Sheung Wan
Hong Kong
Skyvast Securities Limited
FLAT 3304, 33/F, Bank of America Tower
12 Harcourt Road
Central
Hong Kong
Somerley Capital Limited
20/F China Building
29 Queen’s Road Central
Hong Kong
Tiger Brokers (HK) Global Limited
23/F, Li Po Chun Chambers
189 Des Voeux Road Central
Hong Kong
uSmart Securities Limited
Room 2602A, 26/F, Tower 1 Lippo Centre
89 Queensway
Admiralty
Hong Kong
Webull Securities Limited
Suites 2509-12, 25/F, Tower 6, The Gateway, Harbour
City
9 Canton Road
Hong Kong
Zhongtai International Securities Limited
19 Floor, Li Po Chun Chambers
189 Des Voeux Road Central
Hong Kong
ZMF Asset Management Limited
2502, World Wide House
19 Des Voeux Road Central
Hong Kong
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
–7 0–


--- page 79 ---
Legal Advisors to
the Company
As to Hong Kong law:
Tian Yuan Law Firm LLP
Suites 3304–3309, 33/F, Jardine House
One Connaught Place
Central Hong Kong
As to PRC law:
JunHe LLP
26/F, HKRI Centre One
HKRI Taikoo Hui 288 Shimen Road (No. 1)
Shanghai
PRC
As to U.S. law in relation to our business operation
in the U.S.:
King and Wood LLP
600 Fifth Avenue
27th Floor
New York NY 10020
As to PRC intellectual property law:
Tian Yuan Law Firm
Unit 509 Tower A, Corporation Square
35 Financial Street, Xicheng District
Beijing
China
As to PRC data compliance laws:
Grandall Law Firm (Shenzhen)
42/F, 41/F, 31 DE, 2403, 2405
Shenzhen Special Zone Press Tower
6008 Shennan Avenue
Shenzhen
PRC
As to U.S. data compliance laws:
Concord & Sage PC
1360 Valley Vista Dr., Suite 140
Diamond Bar, CA 91765
USA
Legal Advisers to the
Joint Sponsors and
the Underwriters
As to Hong Kong law:
Eric Chow & Co. in Associate with
Commerce & Finance Law Offices
3401, Alexandra House
18 Chater Road
Central
Hong Kong
As to PRC law:
Commerce & Finance Law Offices
12/F−15/F
China World Office 2
No. 1 Jian Guo Men Wai Avenue
Chaoyang District
Beijing
PRC
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
–7 1–


--- page 80 ---
Reporting Accountants Deloitte T ouche T ohmatsu
Certified Public Accountants
Registered Public Interest Entity Auditor
35th floor, One Pacific Place
88 Queensway
Hong Kong
Industry Consultant Frost & Sullivan (Beijing) Inc., Shanghai Branch
Co.
Suite 2504 Wheelock Square
1717 Nanjing West Road
Shanghai
PRC
Receiving Banks CMB Wing Lung Bank Limited
45 Des Voeux Road
Central
Hong Kong
DIRECTORS AND PARTIES INVOLVED IN THE GLOBAL OFFERING
–7 2–


--- page 81 ---
Registered Office Room B06, 26th Floor, Building 5
Digital China Science and Technology Park
No. 20, Zhangba 4th Road
High-tech Development Zone
Xi’an
Shaanxi Province
PRC
Head Office and Principal
Place of Business in the PRC
Building 6, Collaborative Innovation Port
Chang’an District
Xi’an
Shaanxi Province
PRC
Principal Place of Business in
Hong Kong
31/F, Tower Two
Times Square, 1 Matheson Street
Causeway Bay
Hong Kong
Company’s Website www.micot.cn
(The information contained on this website does not form
part of this prospectus)
Joint Company Secretaries Mr. Zou Ran (ཅ್)
Room B06, 26th Floor, Building 5
Digital China Science and Technology Park
No. 20, Zhangba 4th Road
High-tech Development Zone
Xi’an
Shaanxi Province
PRC
Ms. Chan Yee Lam (௓ၥᔝ)
31/F, Tower Two
Times Square, 1 Matheson Street
Causeway Bay
Hong Kong
Authorized Representatives Dr. Wang Bing (ˮΏ)
No. 2504, Unit 2, Building 5
North Area
Residential Area
Jiaotong Medical College
No. 239, Yanta West Road
Yanta District
Xi’an, Shaanxi Province
PRC
Ms. Chan Yee Lam (௓ၥᔝ)
31/F, Tower Two
Times Square, 1 Matheson Street
Causeway Bay
Hong Kong
Audit Committee Mr. Zhang Wenqiang (ੵ˖੶) (Chairperson)
Mr. Wang Kaifeng (ࢤ)
Dr. Wang Mei (ˮૠ)
CORPORATE INFORMATION
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--- page 82 ---
Nomination Committee Dr. Wang Bing (ˮΏ) (Chairperson)
Dr. Wang Mei (ˮૠ)
Mr. Zhang Wenqiang (ੵ˖੶)
Dr. Xiangli Liuxu (Ԣʬᚃ)
Mr. Wang Kaifeng (ࢤ)
Remuneration Committee Dr. Xiangli Liuxu (Ԣʬᚃ) (Chairperson)
Mr. Wang Kaifeng (ࢤ)
Dr. Wang Bing (ˮΏ)
Compliance Adviser Halcyon Capital Limited
Room 3401, 34/F.
Hopewell Centre
183 Queen’s Road East
Wan Chai
Hong Kong
H Share Registrar T ricor Investor Services Limited
17/F
Far East Finance Centre
16 Harcourt Road
Hong Kong
Principal Bank China Merchants Bank Limited
(Xi’an Zhuque Street Branch)
1st floor, Block C
Nanfang Xingzuo
No. 19 Zhuque Street
Yanta District
Xi’an City, Shaanxi Province
PRC
CORPORATE INFORMATION
–7 4–


--- page 83 ---
The information and statistics set out in this section and other sections of this
Prospectus were extracted from the Frost & Sullivan Report, and from various official
government publications and other publicly available publications. We engaged Frost &
Sullivan to prepare the Frost & Sullivan Report, an independent industry report, in
connection with the Global Offering. The information from official government sources has
not been independently verified by us, the Joint Sponsors, Overall Coordinators, Joint Global
Coordinators, Joint Bookrunners, Joint Lead Managers, Underwriters, any of their respective
directors and advisors, or any other persons or parties involved in the Global Offering, and no
representation is given as to its accuracy. Accordingly, you should not place undue reliance on
information, statistics and data from official government sources. For more details of the risks
relating to our industry, see “Risk Factors” in this Prospectus.
1. OVERVIEW OF PEPTIDE DRUG MARKET
Peptide drugs are composed of a defined sequence of amino acids, typically
possessing a molecular weight ranging from 500 to 5,000 Daltons. They function by acting
as agonists or antagonists of endogenous peptides or proteins, exerting their therapeutic
effects through high-affinity and high-specificity binding to biological targets.
The global peptide drug market has grown from USD62.8 billion in 2020 to
USD139.3 billion in 2025 with a CAGR of 17.3%, and is estimated to reach USD267.6 billion
by 2030, at a CAGR of 13.9%. Given the advantages of peptide drugs, their clinical
applications will further expand to multiple areas such as cardiovascular diseases,
tumors, and immune regulation. The peptide drug market in China has experienced an
accelerated growth trend due to favorable policies, increasing treatment demand and
technological iteration and upgrading. The peptide drug market in China has grown from
RMB58.9 billion in 2020 to RMB70.0 billion in 2025, at a CAGR of 3.5%, and is estimated to
reach RMB174.2 billion by 2030, at a CAGR of 20.0% during this period. Driven by aging
populations, rising chronic disease rates and advances in costly innovative therapies, cost
containment has become a key trend in global healthcare. Under fiscal pressure,
governments and third-party payers (public and commercial insurers) are controlling
surging medical spending by limiting coverage and adjusting reimbursement for specific
drugs. Although healthcare cost control has become a global norm, this trend has also
driven structural optimization of healthcare payment systems, channeling limited public
healthcare funds and commercial insurance resources to prioritize coverage for
innovative drugs with differentiated clinical value — specifically those featuring novel
target combinations, new mechanisms of action and the ability to effectively address
unmet clinical needs.
Market Drivers of Peptide Drug Market
Vast and unmet therapeutic demand created by the pandemic of chronic diseases:
According to WHO, the global obese population has exceeded one billion and is closely
linked to an increased risk of developing numerous conditions, including type 2 diabetes
and certain cancers. Peptide drugs, exemplified by GLP-1 agonists, have, for the first time,
achieved safe and effective weight loss comparable to bariatric surgery through
pharmacological means, addressing this immense market need. Concurrently, the aging of
the global population has led to a continuous expansion of the patient base for related
chronic conditions such as CKD and osteoporosis. According to literature published in The
Lancet , the prevalence and burden of CKD continue to rise in tandem with global
population aging. Osteoporosis disrupts calcium and phosphorus metabolism and may
induce or worsen chronic kidney disease-secondary hyperparathyroidism (CKD-SHPT),
further driving corresponding treatment demand and providing a stable foundational
market for peptide drugs.
The advent and development of multi-target peptides: Compared with single-target
peptides, multi-target peptides can simultaneously act upon multiple intrinsically linked
targets within a disease, producing synergistic effects that hold promise for enhanced
efficacy and safety. For instance, Eli Lilly’s dual-target peptide, tirzepatide, has
demonstrated significant clinical and commercial value in the fields of glucose control
and weight reduction. Compared to single-target drugs, dual- or triple-target GLP-1
agonists demonstrate a 30-50% improvement in weight loss efficacy.
INDUSTRY OVERVIEW
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Innovation in oral formulation development: The emergence and commercialization
of oral formulations have marked a breakthrough in the field of peptide therapeutics, w hich
significantly enhance patient convenience and treatment compliance. Unlike conventional
peptide delivery methods, such as intravenous injection or intramuscular injection, which
often require professional medical supervision or frequent clinic visits, oral peptide
formulations enable patients to administer medications independently in the comfort of
their homes.
2. OVERVIEW OF METABOLIC DISEASE DRUG MARKET
Metabolic diseases refer to a series of diseases caused by disorders of substance
metabolism in the body (such as carbohydrates, lipids, proteins, purines, etc.). Disorders
of substance metabolism in the body can damage organs such as the kidneys; if this
condition persists for a long time, it may lead to organ failure, which in turn can induce or
exacerbate diseases like CKD. Common metabolic diseases include CKD, obesity and
being overweight, metabolic dysfunction-associated steatohepatitis, and other conditions.
Overview of Chronic Kidney Disease (CKD) Market
CKD is a group of chronic diseases centered on abnormalities in renal structure or
function. Its diagnostic criteria are renal damage or a decrease in glomerular filtration rate
(GFR) lasting for 3 months or longer. The core feature of CKD is a progressive decline in
renal function, which prevents the kidneys from normally performing key tasks such as
excretion of metabolic waste products, regulation of water and electrolyte balance, and
endocrine functions. Common etiologies include diabetic nephropathy, hypertensive
nephropathy, primary glomerulonephritis, and polycystic kidney disease, among which
diabetes and hypertension are the primary driving factors for the global incidence of
CKD. Clinically, CKD is classified into stages 1 to 5 based on GFR levels. In stage 1, renal
function is basically normal; stage 5 is end-stage renal disease, where patients need to rely
on dialysis or renal transplantation to sustain life. CKD not only affects the kidneys
themselves but also causes systemic multisystem complications, such as renal anemia,
chronic kidney disease-secondary hyperparathyroidism (CKD-SHPT), and cardiovascular
diseases (e.g., heart failure, arteriosclerosis). Among these, CKD-SHPT is particularly
common in patients with CKD in middle and advanced stages, seriously endangering
patients’ quality of life and lifespan.
The global prevalence of CKD grew from 936.3 million in 2020 to 1,100.4 million in
2025, and is projected to reach 1,289.7 million by 2030 and 1,505.1 million by 2035. In
China, the prevalence of CKD grew from 152.0 million in 2020 to 163.8 million in 2025, and
is projected to reach 175.0 million by 2030 and 185.8 million by 2035.
Market drivers of CKD drugs market
• Synergistic Effects of Increasing Prevalence and Population Aging. The prevalence
of CKD is continuously rising, attributable to the high incidence of metabolic
disorders such as diabetes mellitus and hypertension, as well as the impacts of
unhealthy lifestyles. The acceleration of population aging has led to an
increase in the proportion of the elderly population, which are more prone to
comorbid chronic diseases. The complexity of their conditions has also
elevated the difficulty of diagnosis and treatment as well as the consumption
of medical resources.
• Innovations and Breakthroughs in Diagnostic and Monitoring Technologies.
Innovations in diagnostic and monitoring technologies have optimized the
diagnostic and therapeutic workflow of CKD. AI algorithms can accurately
identify early signs of renal injury, enhancing diagnostic precision; the
integration of smart wearable devices with telemedicine has enabled real-time
monitoring of renal function parameters, furnishing data support for early
screening and personalized diagnosis and treatment.
• Transformation of Chronic Disease Management Models. The management model
of CKD has shifted from end-stage treatment to full-cycle comprehensive
management. The hierarchical diagnosis and treatment system has optimized
the allocation of medical resources, digital tools have improved patients’
treatment adherence, and the multidisciplinary collaboration model has
provided integrated diagnostic and therapeutic services for patients,
effectively decelerating the progression of CKD.
INDUSTRY OVERVIEW
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Entry barriers of CKD drug market
• Technical Barriers. CKD features a complex pathogenesis, and drug R&D
requires target design for multiple pathological processes such as renal
fibrosis and metabolic disorders, imposing extremely high demands on
pharmaceutical enterprises’ basic research capabilities and target
development technologies. In addition, enterprises producing mainstream
existing drugs have established a full-chain patent system covering
compounds, processes and indications, forming a technical monopoly, and
new entrants are prone to intellectual property disputes.
• Policy Barriers. Drug regulatory authorities worldwide implement high
standards for the approval of CKD drugs, requiring the provision of clear
clinical benefits and comprehensive safety data. The approval process for
innovative drugs takes 3-5 years or even longer. Meanwhile, medical
insurance access requires passing strict economic evaluations. Hospital
procurement tends to favor mature brands, and new drugs face long cycles of
academic promotion and access, further raising the policy threshold.
• Financial Barriers. CKD drug R&D is characterized by long cycles and high
failure rates, with huge financial investment requirement. The production end
needs to construct GMP-compliant production lines, entailing high upfront
fixed costs. Meanwhile, after the launch of new drugs, continuous capital
investment is necessary for market promotion. Enterprises lacking sufficient
financial strength are unable to break through this barrier.
Overview of Chronic Kidney Disease-Secondary Hyperparathyroidism (CKD-SHPT)
Market
CKD-SHPT is a common and severe complication in patients with CKD, particularly
those with end-stage renal disease receiving dialysis, and represents one of the core
manifestations of CKD-mineral and bone disorder. Its pathogenesis mainly arises from
impaired phosphorus excretion caused by progressive renal function decline, leading to
hyperphosphatemia, insufficient synthesis of active vitamin D and hypocalcemia;
abnormalities in regulatory pathways including the calcium-sensing receptor and vitamin
D receptor continuously stimulate excessive secretion of parathyroid hormone by the
parathyroid glands, which further results in diffuse or nodular hyperplasia of the
parathyroid glands and forms a vicious cycle of autonomous hypersecretion of PTH. In
patients with CKD-SHPT, long-term, sustained excessive secretion of parathyroid
hormone (PTH) over-activates osteoclast-mediated bone resorption and inhibits
osteoblast-mediated bone formation, resulting in a rate of bone resorption that far exceeds
bone formation. This causes continuous dissolution of hydroxyapatite crystals in bone
and massive mobilization of calcium and phosphorus minerals into the bloodstream. The
massive loss of bone calcium, combined with hyperphosphatemia caused by CKD-SHPT
itself, significantly increases the calcium-phosphorus product beyond the normal
threshold, leading to ectopic deposition of calcium-phosphate complexes in blood vessel
walls, heart valves and other soft tissues. Consequently, CKD-SHPT may give rise to renal
osteodystrophy, vascular and soft tissue calcification and other disorders, clinically
manifesting as bone pain, increased bone fragility, pathological fractures, vascular
stiffness and increased cardiovascular burden, and significantly increases the risk of
adverse cardiovascular events and mortality among affected patients.
CKD-SHPT, as a secondary complication stemming from chronic diseases, is a
chronic condition characterised by non-curability in the short term and a requirement for
lifelong management. Per industry practice, prevalence data is generally utilised to
measure and reflect the scale of the existing patient pool for such chronic illnesses. Given
the insidious onset of CKD-SHPT, its exact time of onset is often difficult to be precisely
determined, making incidence data quite challenging to compile and as such the data set
might be biased. To date, there are few dedicated industry-wide studies focusing on the
incidence of CKD-SHPT. Accordingly, prevalence data carries greater industry-referential
value and practical research feasibility for CKD-SHPT when compared with incidence
data. The global prevalence of CKD-SHPT grew from 136.5 million in 2020 to 160.4 million
in 2025, and is projected to reach 188.0 million by 2030 and 219.4 million by 2035. The
prevalence of CKD-SHPT in China grew from 13.0 million in 2020 to 14.0 million in 2025,
and is projected to reach 15.0 million by 2030 and 15.9 million by 2035. The global
population of patients with Stage 5 CKD complicated by SHPT expanded from 5.0 million
in 2020 to 5.9 million in 2025. This cohort is projected to reach 6.9 million by 2030 and 8.1
million by 2035. Concurrently, the patient population in China grew from 0.60 million in
2020 to 0.65 million in 2025, and is forecasted to hit 0.69 million by 2030 and 0.73 million
by 2035.
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Main treatment of CKD-SHPT
In the field of CKD-SHPT treatment, there is no concept of first-line, second-line, or
other sequential therapies. The choice of a specific treatment regimen depends entirely on
whether the patient meets the eligibility criteria for the medication. In the early stages,
CKD-SHPT can be effectively managed with medical therapy. For example, phosphorus
binding agents, vitamin D and its analogs, and calcium-sensitive receptor agonists can
control the patient’s parathyroid hormone levels to some extent in the early stages of the
disease. Phosphorus binding agents inhibit parathyroid cell proliferation by lowering
blood phosphorus levels, which in turn reduces parathyroid hormone levels. Vitamin D
and its analogs regulate calcium and phosphorus metabolism and inhibit parathyroid
hormone production by inhibiting osteoclasts, promoting osteoblasts, and intestinal
calcium absorption.
CaSR agonists inhibit parathyroid hormone production by increasing the sensitivity
of calcium-sensitive receptors to extracellular calcium and binding to receptor variants.
The potential for severe gastrointestinal reactions, drug-drug interactions, and side effects
such as hypercalcemia and hyperphosphatemia greatly reduce patient compliance, while
increased drug resistance further reduces efficacy as the patient’s disease progresses.
Surgical intervention is still needed for patients who fail drug therapy or have advanced
CKD-SHPT, with parathyroidectomy being the main surgical procedure.
Market size of CKD-SHPT drugs
Between 2020 and 2025, core drugs for the treatment of CKD-SHPT in China have
fully completed generic substitution and been successively included in the national
volume-based procurement, resulting in a significant decline in the overall average selling
price of the market. As of the end of 2025, all mainstream CKD-SHPT treatment drugs are
small-molecule drugs, including oral CaSR agonist cinacalcet, vitamin D analog
paricalcitol, traditional vitamin D drug calcitriol, and phosphate binders lanthanum
carbonate and sevelamer, have been included in the national or local centralized drug
procurement programs, leading to a substantial drop in the overall average selling price.
Between 2020 and 2025, the average selling price of CKD-SHPT drugs declined by
approximately 80%. The aforementioned mainstream CKD-SHPT drugs were all included
in the NRDL at an early stage, and the implementation of volume-based procurement has
further significantly reduced the financial burden on patients and greatly improved drug
accessibility. Meanwhile, with the continuous increase in the dialysis rate of patients with
CKD in China and the improvement in CKD-SHPT disease screening and diagnosis
capabilities, the number of CKD-SHPT patients receiving standardized pharmacotherapy
has achieved rapid growth. Between 2020 and 2025, annual sales volume of CKD-SHPT
drugs increased by 3 to 5 times. The significant decline in the average selling price of
CKD-SHPT drugs and the rapid growth in their sales volume have offset each other,
resulting in a minimal growth of only 0.7% in the market size of CKD-SHPT drugs in
China Mainland from 2020 to 2025, increasing from RMB2.0 billion to RMB2.1 billion.
With the approval and launch of peptide-based CaSR agonists, the domestic
CKD-SHPT drug market is poised for rapid growth, with the specific market drivers
outlined below:
• Multiple peptide-based CaSR agonists will be launched successively and
included in the NRDL, improving drug accessibility: Etelcalcetide was
approved by NMPA in May 2023 and has not yet been included in the NRDL.
In addition, two other peptide-based CaSR agonists (MT1013 and SHR6508)
are in Phase III clinical trials and nearing approval for launch. As most other
drugs in the CKD-SHPT treatment field have already been included in the
NRDL, all three drugs are expected to be successively included in the NRDL
through national medical insurance negotiations within the next 2 to 3 years,
enhancing their accessibility and achieving commercial volume expansion.
• The treatment cost of peptide-based CKD-SHPT drugs will be significantly
higher than that of small-molecule SHPT drugs, driving up the average
treatment cost of CKD-SHPT drugs: Currently, the monthly treatment cost of
mainstream small-molecule CKD-SHPT drugs is less than RMB100, while the
monthly treatment cost of peptide-based CaSR agonists exceeds RMB2,000.
INDUSTRY OVERVIEW
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Even after being included in the NRDL, the projected monthly treatment cost
of peptide-based CaSR agonists will still be more than 10 times that of the
existing post-procurement small-molecule CaSR agonist cinacalcet, which
will raise the overall average treatment cost of CKD-SHPT drugs.
• The small-molecule CaSR agonist cinacalcet is constrained by high incidence
of gastrointestinal adverse reactions and poor patient treatment compliance,
which hinders the improvement of its market penetration and expansion of its
market space. Cinacalcet features a relatively high incidence of
gastrointestinal adverse reactions, leading numerous patients to discontinue
treatment due to intolerance to such reactions. Meanwhile, as an oral
formulation, it comes with stringent administration requirements coupled
with prominent side effects, further resulting in frequent missed doses,
arbitrary dosage adjustment and even premature treatment cessation among
patients, thus resulting in unsatisfactory overall treatment compliance. The
aforesaid gastrointestinal adverse reactions and compliance issues not only
constrain the market penetration of cinacalcet, but also restrict the overall
treatment rate of CKD-SHPT patients, ultimately forming a bottleneck that
curbs further growth of its market size.
• Peptide-based CaSR agonists avoid the common adverse reactions of
small-molecule CaSR agonists and expand the eligible patient population:
Peptide-based CaSR agonists are administered intravenously and directly
enter the blood circulation, avoiding the severe gastrointestinal adverse
reactions commonly associated with oral cinacalcet, enabling a large number
of patients who were previously unable to tolerate oral treatment to receive
standardized therapy. They also carry a lower risk of causing hypercalcemia
and hyperphosphatemia, and their indication scope can be extended to
patients with all stages of CKD-SHPT.
• Peptide-based CaSR agonists can be administered concurrently with dialysis,
compared to small-molecule CaSR agonists, can significantly improve
patient treatment adherence: These agents can be directly administered by
medical staff through dialysis lines during patients’ routine dialysis sessions,
completely resolving the common problems of missed doses, self-medication
reduction, and treatment discontinuation associated with oral drugs, and
significantly improving patient treatment adherence.
Driven by the continuous increase in market penetration resulting from improved
accessibility following the commercial launch and NRDL inclusion of peptide-based
CKD-SHPT drugs, the rise in overall patient treatment rate and expansion of the eligible
patient population brought about by their superior safety and treatment adherence
advantages, as well as their higher treatment costs compared to small-molecule
CKD-SHPT drugs, both the sales volume and average treatment cost per patient of
CKD-SHPT drugs will be simultaneously boosted, thereby propelling the rapid expansion
of the domestic CKD-SHPT drug market. It is projected that the market size will reach
RMB5.0 billion by 2030 and RMB13.1 billion by 2035, representing CAGRs of 18.7% and
21.4% respectively during the corresponding periods.
CKD-SHPT drug market in China, 2020-2035
2020 2021 2022 2023 2024 2025 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E 2034E 2035E
2.7 2.2 2.2 2.1 2.2 2.4 2.9 3.8 5.0 6.8
9.3 10.3 11.9 13.1
2.0 2.8
Billion RMB
Period
2020-2025 0.7%
CAGR
2025-2030E 18.7%
2030E-2035E 21.4%
Source: Annual Reports of Listed Companies, Expert Interviews, Frost & Sullivan Report
INDUSTRY OVERVIEW
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Overview of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) Market
CKD-MBD is a common complication in CKD patients, characterized by mineral
metabolism disorders, bone metabolism and structural abnormalities, as well as vascular
and other soft tissue calcifications. It represents a systemic manifestation of multisystem
involvement during CKD progression. Patients with CKD-MBD may experience bone
pain, deformities, and increased fracture risk in the skeletal system, while children may
also exhibit growth retardation. The cardiovascular system experiences accelerated
atherosclerosis and elevated blood pressure due to vascular calcification, triggering
coronary heart disease, heart failure, and even sudden death — a major contributor to
elevated cardiovascular mortality risk. Additionally, soft tissue calcification causes
localized pain, while hyperparathyroidism exacerbates metabolic imbalance, creating a
vicious cycle that significantly increases disability rates and mortality while severely
compromising quality of life and survival prognosis. The NHANES study found that
CKD-MBD patients with serum phosphorus ≥4.5 mg/dL had a 28% increase in all-cause
mortality and a 57% increase in cardiovascular mortality. The CORES study showed that
CKD patients with serum calcium <9.5 mg/dL or >10.5 mg/dL both experienced elevated
all-cause mortality.
The global prevalence of CKD-MBD grew from 291.7 million in 2020 to 342.8 million
in 2025, and is projected to reach 403.0 million by 2030 and 470.3 million by 2035. The
prevalence of CKD-MBD in China grew from 47.0 million in 2020 to 50.6 million in 2025,
and is projected to reach 54.1 million by 2030 and 57.4 million by 2035.
Main treatment of CKD-MBD
The treatment of CKD-MBD is a comprehensive regimen centered on correcting
calcium-phosphorus metabolism imbalance and inhibiting hyperparathyroidism, mainly
consisting of basic nutritional and lifestyle interventions, pharmacotherapy, and surgical
treatment.
T reatment Paradigm of CKD-MBD
Hyperphosphatemia
• Calcium-free phosphate binders: Sevelamer,
Lanthanum carbonate
•
•
•
•
•
Hypercalcemia Serum calcium >
2.75 mmol/L
Vitamin D
deficiency
25(OH)D <
30 ng/mL
Serum calcium & iPTH
& serum phosphorus >
target values.
iPTH > target value
Serum phosphorus >
target value
•Failure of
drug therapy
CKD-MBD
CKD-SHPT
Eligibility Criteria Appropriate treatment methodsClinical Symptoms
Calcium-containing phosphate binders: Calcium carbonate
Active vitamin D analogs: Calcitriol, Paricalcitol, Alfacalcidol
CaSR agonist: Cinacalcet, Etelcalcetide, Evocalcet
Parathyroidectomy: Total parathyroidectomy,
subtotal parathyroidectomy, total parathyroidectomy
with autotransplantation
Vitamin D: Cholecalciferol (Vitamin D
3)
Active vitamin D: Calcitriol
•
•
Calcium-lowering agents: Calcitonin
Bisphosphonates: Zoledronic acid
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Efficacy and Safety Profile of Standard T reatment for CKD-MBD
Phosphate Binders
(Lanthanum
Carbonate)
Patients with Stage
3-5 CKD
complicated with
hyperphosphatemia
Global: 60.0 million
China: 5.2 million
Potently reduces serum phosphorus levels,
lowers the risk of vascular calcification,
and serves as an adjuvant therapy to
stabilize patients' PTH levels
The core adverse reactions are
gastrointestinal reactions, with
favorable tolerability and safety
profile for long-term use
Phosphate Binders
(Calcium Carbonate)
Patients with Stage
3-5 CKD
complicated with
hyperphosphatemia
Global: 60.0 million
China: 5.2 million
Binds to phosphate to reduce its absorption
and lower serum phosphorus levels, while
supplementing calcium to correct
hypocalcemia and inhibit excessive PTH
secretion from the parathyroid glands, with
a rapid onset of action
It may cause hypercalcemia;
long-term excessive use may
accelerate calcification of blood
vessels and soft tissues, and
gastrointestinal adverse reactions
are common
Active Vitamin D
(Calcitriol)
Patients with Stage
5 CKD
complicated with
CKD-SHPT
Global: 5.9 million
China: 0.6 million
Directly acts on the vitamin D receptors of
the parathyroid glands, potently inhibits the
synthesis and secretion of PTH, and rapidly
reduces serum PTH levels
The core adverse reactions include
hypercalcemia and
hyperphosphatemia. Excessively
high dosage may induce
overinhibition of PTH, resulting in
adynamic bone disease
Active Vitamin D
Analogues
(Paricalcitol)
Patients with Stage
5 CKD
complicated with
CKD-SHPT
Global: 5.9 million
China: 0.6 million
With high targeting specificity to the
vitamin D receptors of the parathyroid
glands, it potently inhibits the synthesis and
secretion of PTH with a minimal impact on
ser
um calcium and phosphorus levels.
It has a significantly lower
incidence of hypercalcemia and
hyperphosphatemia, with a superior
safety profile and favorable
long-term tolerability
CaSR agonist
(Cinacalcet)
Patients with Stage
5 CKD
complicated with
CKD-SHPT
Global: 5.9 million
China: 0.6 million
Activates the CaSR to enhance the
sensitivity of the receptors to serum
calcium. It potently inhibits the synthesis
and secretion of PTH without increasing
serum calcium, while simultaneously
reducing serum phosphorus levels
The core adverse reaction is
dose-dependent hypocalcemia,
with common mild to moderate
gastrointestinal reactions
Bisphosphonates
(Alendronate
Sodium)
Patients with CKD
complicated with
osteoporosis
Global: 121.3 million
China: 10.8 million
Binds to bone mineralization sites with
high affinity, specifically inhibits osteoclast
activity and reduces bone resorption,
significantly increases bone mineral
density, lowers the risk of fragility
fractures, and delays bone mass loss.
It has a favorable safety profile in
patients with Stage 1-3 CKD; for
patients with Stage 4-5 CKD,
cautious use with dose reduction is
required to avoid exacerbation of
renal impairment
Calcium-lowering
Agents
(Calcitonin)
Patients with CKD
complicated with
osteoporosis
Global: 121.3 million
China: 10.8 million
For patients with osteoporosis, it reduces
bone calcium loss and relieves bone pain,
with a rapid onset of action. However, it
provides no long-term prognostic
improvement
Short-term use has no risk of
elevated serum calcium and
phosphorus, with a favorable safety
profile. Long-term use may cause
dose-dependent hypocalcemi
a, and
there is a risk of immunogenicity
Standard
Treatment
(Representative
Drug)
Recommended
Indicated
Patient
Global and
Chinese Indicated
Patients in 2025
Efficacy Safety Profile
Source: Chinese guidelines for the diagnosis and treatment of mineral and bone disorders in chronic kidney disease,
Frost & Sullivan Report
Market size of CKD-MBD drugs
In 2025, the market size of CKD-MBD drugs in China reached RMB5.7 billion. It is
estimated that the market size will reach RMB9.9 billion by 2030 and RMB19.8 billion by
2035, with the CAGR of 11.7% and 14.8%, respectively, during the period.
CKD-MBD drugs market in China, 2020-2035
2020 2021 2022 2023 2024 2025 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E 2034E 2035E
7.1 6.5 6.3 5.7 6.0 6.5 7.2 8.4 9.9
12.1
15.0 16.3 18.3 19.8
5.4 6.8
Billion RMB
Period
2020-2025 1.3%
CAGR
2025-2030E 11.7%
2030E-2035E 14.8%
Source: Annual Reports of Listed Companies, Expert Interviews, Frost & Sullivan Report
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Overview of CaSR and OGP Agonist Drugs Market
Calcium-sensing receptor (CaSR) i saGp r otein-coupled receptor distributed in
parathyroid glands, kidneys, and other tissues, and its core function is to sense changes in
extracellular calcium ion concentration and regulate the secretion of parathyroid hormone
(PTH) through negative feedback to maintain calcium metabolism homeostasis. CaSR
agonists enhance their sensitivity to extracellular calcium by binding to CaSR, which can
activate the CaSR signaling pathway and directly inhibit the secretion of PTH by
parathyroid master cells even when blood calcium levels are not high; at the same time,
prolonged use of these agents reduces the proliferation of parathyroid cells and slows
down the process of glandular hyperplasia. This mechanism can not only reduce the blood
PTH level, but also indirectly improve the calcium and phosphorus metabolism disorder,
thus alleviating the complications of bone pain, fracture and vascular calcification caused
by CKD-SHPT.
The first generation of CaSR receptor agonists is cinacalcet, as the first approved
drug, which is used to treat calcium metabolism disorders such as CKD-SHPT in chronic
kidney disease by activating calcium-sensitive receptors to inhibit PTH secretion, but it
has significant drawbacks, including a high incidence of gastrointestinal side effects,
susceptibility to hypercalcemia, and limited effects on severe parathyroid hyperplasia and
requires daily dosing. The second generation of drugs includes Evocalcet and
Etelcalcetide, of which Evocalcet reduces the risk of gastrointestinal reactions and drug
interactions through structural optimization, and Etelcalcetide avoids oral side effects
and has a stronger activation effect due to intravenous injection, which improves the
safety of the first generation as a whole, but there are still shortcomings to be solved, such
as an increased incidence of hypocalcemia, and severe hypocalcemia still requires
emergency intervention, and the insufficient efficacy for severe parathyroid hyperplasia
requires combination therapy, and the convenience of drug administration is not easy.
Combination therapy is needed for severe parathyroid hyperplasia, and the convenience
of drug administration needs to be improved.
Osteogenic growth peptide (OGP) is an active peptide involved in the regulation of
bone metabolism, which can promote the proliferation of osteoblasts, enhance osteogenic
activity, stimulate the synthesis of collagen and the formation of bone matrix, and regulate
the process of bone formation. OGP has the potential to combat the symptoms of excessive
bone resorption activity and inhibited bone formation caused by CKD-SHPT. By
promoting bone formation, it can reduce the excessive release of calcium from bones,
facilitate the deposition of calcium and phosphorus to bone tissue, and indirectly stabilize
the levels of blood phosphorus and blood calcium — thereby alleviating the stimulation to
the parathyroid glands caused by calcium loss from bones. Although no OGP-targeting
drugs have been approved, OGP’s bone metabolism regulation mechanism holds
therapeutic promise for CKD-MBD-related conditions.
Competitive landscape of CaSR agonist
As of the latest practicable date, there are two CaSR agonist drugs approved by
FDA.
Global competitive landscape of CaSR agonist
Target Drug Name Brand Name Company Indication Dosage
Form Approval Date
2017-02-07CASR Etelcalcetide Parsabiv Amgen CKD-SHPT
2004-03-08CASRC inacalcet Sensipar Amgen CKD-SHPT,
Hypercalcemia Oral
Injection
Source: FDA, Frost & Sullivan Analysis
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As of the latest practicable date, there are three CaSR agonist drugs approved by
NMPA.
Competitive landscape of CaSR agonist in China
Target Drug Name Brand
Name Company Indication Dosage
Form
Market share
in 2024
(by revenue)
Approval Date
2014-08-21
2023-05-06
2024-07-30
NRDL
Status
List B
Not
Included
List B
CASR
CASR
CASR
Etelcalcetide
Evocalcet
Cinacalcet
Parsabiv
Sensipar
Amgen
Amgen
CKD-SHPT
Orkedia Kyowa Kirin CKD-SHPT
CKD-SHPT,
Hypercalcemia
Injection
Oral
Oral 99.6%
0.4%
0.0%
Annual
Treatment
Cost
(thousand RMB)
5.9
43.7
24.1
Source: NMP A, Frost & Sullivan Analysis
As of the latest practicable date, there are five CaSR agonist drug candidates for
CKD-SHPT in the clinical stage globally.
Global competitive landscape of CaSR agonist pipelines
Target Drug Code Company Dosage Form Regulatory
Authorities
Clinical
Stage
Latest Update
Date
CASR
CASR
CASR
CASR
CASR, OGP
Upacicalcet
Evocalcet
SHR-6508
ASP7991
MT1013
Pathalys Pharma
Kyowa Kirin
Hengrui Pharmaceutical
Astellas Pharma
Shaanxi Micot Pharmaceutical
Technology
Oral
Oral
Injection
Oral
Injection
FDA
FDA
NMPA
FDA
NMPA
Phase III
Phase III
Phase III
Phase II
Phase III
2025-09-09
2022-04-25
2025-12-27
2024-11-06
2025-10-09
FDA Phase I 2022-07-29
Source: ClinicalTrials.gov, CDE, Frost & Sullivan Analysis
Overview of Overweight and Obesity Market
Overweight and obesity are chronic diseases characterized by excessive fat
accumulation that poses risks to health. These conditions are the major contributors to
various other health issues, such as diabetes and cardiovascular diseases. The global
prevalence of overweight and obesity patients grew from 2,275.7 million in 2020 to 2,687.4
million in 2025, and is projected to reach 3,070.6 million by 2030 and 3,477.2 million by
2035. In China, the prevalence of overweight and obesity increased from 570.7 million in
2020 to 659.1 million in 2025, and is projected to reach 756.5 million by 2030 and 860.5
million by 2035.
Currently, the treatment for overweight and obesity focuses on reducing and
maintaining body weight, as well as managing any associated diseases and complications.
A differentiated approach is typically used, depending on the degree of obesity. For
patients who are overweight but do not have obesity-related conditions, weight control is
primarily achieved through lifestyle interventions such as diet and exercise. For patients
whose health condition process from overweight to obese, medication may be added
alongside with lifestyle interventions to support weight loss. Surgery is considered a last
resort, which is used for patients who are extremely obese and have no effective responses
to other treatments. The current standard of care includes orlistat and GLP-1-based
therapies (e.g., liraglutide, semaglutide, and tirzepatide). GLP-1 RAs are established as
first-line treatments for obesity or overweight management due to their dual efficacy in
glycemic control and weight reduction.
Currently, the primary GLP-1 drugs worldwide are semaglutide (a GLP-1
single-target agonist) and tirzepatide (a GIP/GLP-1 dual-target agonist). Although both
drugs demonstrate significant weight-loss effects, they still face numerous limitations in
clinical application. Semaglutide is associated with gastrointestinal side effects, and
weight loss is accompanied by some muscle loss. Long-term medication is required for
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maintenance, and weight rebound occurs after discontinuation. Tirzepatide demonstrates
superior weight loss efficacy compared to semaglutide, but it also exhibits a higher
incidence of gastrointestinal side effects, greater muscle loss, and faster weight rebound
after discontinuation than semaglutide.
Historically, treatment options for overweight and obesity in China were relatively
limited. The mismatch between existing treatment regimens and clinical needs has
unlocked immense market opportunities for GLP-1 receptor agonists. The research and
development of long-acting GLP-1 drugs can reduce dosing frequency and enhance
patient compliance, which is expected to lift the penetration level of GLP-1 therapeutics.
This will broaden the patient base and further raise market penetration of GLP-1 drugs,
especially against the backdrop of sustained growth in China’s overweight and obese
population. In addition, numerous GLP-1 receptor agonist candidates for the treatment of
overweight and obesity are currently in clinical development across China. In view of the
limited availability of existing therapies, the launch of such novel GLP-1 receptor agonists
is expected to significantly fuel the rapid growth of China’s overweight and obesity drug
market. In 2025, the overweight and obesity drug market in China is RMB5.7 billion. It is
estimated that the overweight and obesity drug market in China will grow to RMB23.5
billion in 2030 and RMB107.3 billion in 2035, with a CAGR of 32.9% from 2025 to 2030 and
35.5% from 2030 to 2035 respectively.
Overweight and obesity drugs market in China, 2020-2035
2020 2021 2022 2023 2024 2025 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E 2034E 2035E
4.3 4.8 4.2 5.7 7.9 11.0 13.2 17.0 23.5
32.7
45.4
62.6
83.5
107.3
1.9 3.0
Billion RMB
Period
2020-2025 24.4%
CAGR
2025-2030E 32.9%
2030E-2035E 35.5%
Source: Annual Reports of Listed Companies, Expert Interviews, Frost & Sullivan Report
Market drivers and future trends of GLP1R polypeptide drugs market
• Large unmet clinical needs. The prevalence of obesity and overweight has
been rising rapidly among both children/adolescents and senior adults across
China and globally, due to modern lifestyle factors such as excessive calorie
intake and insufficient physical activity. Currently, a number of GLP-1R drugs
have been approved; however, there are still many unmet clinical needs,
including muscle loss after weight loss, severe rebound and deterioration of
body composition profile after discontinuation of treatment, as well as the
failure to fully address various comorbidities commonly associated with
clinically obese patients.
• Rising awareness for obesity and overweight management. The rising public
awareness regarding the health risks associated with obesity and overweight
has led to a surge in demand for effective obesity and overweight
management solutions. According to the China Public Weight Management
and Nutrition Awareness Survey Report (2026), 91.7% of the public recognizes
the importance of weight management. In particular, the younger
generations, who are increasingly impacted by obesity and overweight, are
showing a greater willingness to engage in weight management treatments.
• Multi-targeted GLP-1 peptide drugs become mainstream. Multi-targeted
drugs have become the core track of competition among global
pharmaceutical companies by activating multiple metabolism-related
receptors (e.g., GLP-1R, GIPR, GCGR) at the same time to achieve synergistic
efficacy and optimization of side effects. The multi-target GLP1-related
peptide drugs of many companies have proved to be more effective than
single-target drugs, and multi-target GLP1-related peptide drugs are expected
to occupy a dominant position in the market.
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• Indications for expansion. The earliest GLP-1 drugs were only indicated for
hypoglycemic therapy in diabetic patients. With clinical exploration and the
unmet needs of the large number of obese patients, the indications of GLP-1
peptide drugs have gradually expanded to include metabolic diseases such as
obesity, CKD with albuminuria and MASH. According to Prevalence of Chronic
Kidney Disease in China, more than 80% of CKD patients present with albuminuria .
According to Guideline for Primary Care Diagnosis, Treatment and
Management of Metabolic Associated Fatty Liver Disease (MAFLD) (2025),
China has over 40 million MASH patients, yet current medications only
provide symptomatic relief with limited efficacy. GLP-1 peptides possess the
potential to address these unmet clinical needs and have emerged as one of
the most significant therapeutic approaches in the field of metabolic diseases.
Competitive landscape of GLP1R polypeptide drugs
As of the latest practicable date, there are 17 triple-target GLP1R peptide drug
candidates for overweight and obesity in the clinical stage globally. Among these, 12 drug
candidates target GLP-1R, GCGR, and GIPR, two drug candidates target GLP-1R, GCGR,
and FGF21, one drug candidate targets GLP1R, GIPR, and AMYR, and one drug candidate
targets GLP1R, GIPR, and NPY2R. XTL6001, our GLP1R drug candidate, is the only
triple-target GLP-1R peptide drug candidate targeting GLP-1R, GCGR, and MASR.
Agonizing MasR can increase protein synthesis and preserve muscle mass. XTL6001 holds
the potential to eliminate the side effect of muscle loss associated with GLP-1R agonists
during weight loss.
Global competitive landscape of triple-target GLP1R peptide drugs pipelines
Target Drug Code Company Indication Regulatory
Authorities
Clinical
Stage
Latest Update
Date
GLP1R, GCGR,
MASR XTL6001 Shaanxi Micot Pharmaceutical
Technology
Overweight & Obesity, CKD with proteinuria NMPA Phase I 2026-05-09
Overweight & Obesity FDA IND 2024-12-20
GLP1R, GCGR,
GIPR
Retatrutide
Eli Lilly
Overweight & Obesity, Diabetes Type 2, Chronic Low Back Pain,
ASCVD, CKD, Obstructive Sleep Apnea, Osteoarthritis FDA Phase III 2026-05-22
MASLD NMPA Phase III 2026-05-08
Overweight & Obesity, Diabetes Type 2 FDA Phase I 2026-05-12
LY4086940 Overweight & Obesity NMPA Phase I 2024-07-08
Efocipegtrutide
Hanmi Pharmaceutical
NAFLD FDA Phase II 2025-11-19
Overweight & Obesity FDA Phase I 2025-02-06
HM15275 Overweight & Obesity FDA Phase II 2026-05-26
UBT251
Federal Biotechnology Overweight & Obesity, Type 2 diabetes, MASH, CKD with proteinuria NMPA Phase II 2026-04-24
Novo Nordisk Overweight & Obesity FDA Phase II 2026-02-17
ZX2021 Jiangsu Kanion Pharmaceutical Overweight & Obesity NMPA Phase II 2025-06-18
DYX116 Jiangsu Deyuan Pharmaceutical Type 2 diabetes, Overweight & Obesity NMPA Phase II 2026-05-18
MWN101
Lepu Medical Technology
Type 2 diabetes, Overweight & Obesity NMPA Phase II 2025-01-23
MWN109
Type 2 diabetes, Overweight & Obesity NMPA Phase II 2026-05-30
Overweight & Obesity FDA Phase I 2025-11-20
SAR441255 Sanofi Overweight FDA Phase I 2025-09-22
HEC-007 HEC Pharmaceutical Type 2 diabetes, Overweight & Obesity NMPA Phase I 2026-04-12
HRS-4729 Hengrui Pharma Overweight & Obesity NMPA Phase I 2026-05-07
GLP1R, GCGR,
FGF21
MWN105 Lepu Medical Technology
Overweight & Obesity NMPA Phase II 2025-09-05
Type 2 diabetes, Overweight & Obesity NMPA Phase I 2024-12-27
DR10624 Huadong Medicine MAFLD, Hypertriglyceridemia NMPA Phase II 2026-02-14
GLP1R, GIPR,
AMYR NN9662 Novo Nordisk Overweight & Obesity, Diabetes Type 2 FDA Phase II 2026-05-19
GLP1R, GIP,
NPY2R BI 3034701 Boehringer Ingelheim Overweight & Obesity FDA Phase I 2025-11-21
Source: clinicaltrials.gov, CDE, Frost & Sullivan analysis
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3. OVERVIEW OF THE ANTITHROMBOTIC DRUG MARKET
Overview of Antithrombotic Therapy for ACS-PCI
Acute coronary syndrome (ACS), a type of coronary heart disease (CHD), refers to a
group of conditions that include ST-elevation myocardial infarction (STEMI), non-ST
elevation myocardial infarction (NSTEMI), and unstable angina. From 2020 to 2025, the
incidence of ACS worldwide increased from 23.8 million to 26.6 million. It is estimated
that by 2030 and 2035, the incidence of ACS worldwide will reach 29.1 million and 31.4
million, respectively. From 2020 to 2025, the incidence of ACS in China increased from 4.6
million to 5.2 million. It is estimated that by 2030 and 2035, the incidence of ACS in China
will reach 5.8 million and 6.3 million, respectively.
Percutaneous coronary intervention (PCI) is a non-surgical, invasive procedure
with a goal to relieve the narrowing or occlusion of the coronary artery and improve blood
supply to the ischemic tissue. From 2020 to 2025, the volume of PCI procedures worldwide
increased from 6.2 million to 10.7 million. It is estimated that by 2030 and 2035, the volume
of PCI procedures worldwide will reach 15.6 million and 21.7 million, respectively. From
2020 to 2025, the volume of PCI procedures in China increased from 1.0 million to 2.3
million. It is estimated that by 2030 and 2035, the volume of PCI procedures in China will
reach 4.0 million and 6.0 million, respectively.
Main perioperative treatment of PCI in ACS
Although PCI has become increasingly technically mature, throughout the entire
procedure related medical devices may cause damage to both the access vessel and the
coronary artery, potentially leading to severe complications that threaten patient life. To
prevent in-stent thrombosis, patients are required to undergo antithrombotic therapy,
which includes dual antiplatelet therapy (DAPT) before and after PCI, intraoperative
heparin-based anticoagulation, and the use of glycoprotein IIb/IIIa inhibitors (GPIs)
when necessary.
China is witnessing accelerated population aging alongside a growing elderly
population, and the morbidity rate of thromboembolic diseases rises progressively with
age, forming the core demand group for antithrombotic drugs. Meanwhile, there exists a
substantial patient base suffering from chronic illnesses including cardiovascular
diseases, and the heavy socioeconomic and medical burden imposed by such ailments
fuels sustained clinical treatment needs. The continuous refinement of national clinical
diagnosis and treatment guidelines has facilitated the standardization and normalization
of antithrombotic therapy, thereby further unlocking unmet clinical demand. Leveraging
superior efficacy, favourable safety profiles and higher administration convenience, novel
antithrombotic drugs are rapidly substituting conventional alternatives and reshaping the
market structure. In addition, patients afflicted with thromboembolic diseases generally
require long-term or even lifelong medication use, which underpins steady repeat
purchasing demand. Collectively, the aforesaid factors drive the steady expansion of
China’s antithrombotic drug market.
In 2025, the antithrombotic drugs market in China reached RMB34.5 billion. It is
estimated that the antithrombotic drugs market in China will grow to RMB47.2 billion in
2030 and RMB61.8 billion in 2035, with a CAGR of 6.4% from 2025 to 2030 and 5.6% from
2030 to 2035, respectively.
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Antithrombotic drugs market in China, 2020-2035
2020 2021 2022 2023 2024 2025 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E 2034E 2035E
31.9 32.5 32.7 34.5 36.9 39.4 41.9 44.5 47.2 50.0 52.8 55.7 58.7 61.8
30.5 33.1
Billion RMB
Period
2020-2025 2.5%
CAGR
2025-2030E 6.4%
2030E-2035E 5.6%
Source: Annual Reports of Listed Companies, Expert Interviews, Frost & Sullivan Report
Market drivers and future trends of antithrombotic drugs market
• High Incidence of Cardiovascular Diseases. Cardiovascular diseases (CVDs)
are among the leading causes of mortality worldwide. With the accelerating
progression of global population aging, the incidence and prevalence of CVDs
continue to rise steadily, according to the Report on Cardiovascular Health and
Diseases in China 2024 , the incidence of CVDs and cerebrovascular diseases
among Chinese residents reached 8.7 million in 2023, and the projected
incidence and mortality rates of CVDs in China are expected to rise
continuously over the period from 2020 to 2030, driving an increasing demand
for antithrombotic therapies.
• Heightened Risk of Thrombosis in Interventional Therapies. The continuous
development and widespread adoption of cardiovascular interventional
procedures have significantly improved the treatment outcomes for patients
with CVDs. Nevertheless, these interventions are associated with a
heightened risk of thrombosis during and after the procedures. According to
Complications and Management of Coronary Artery Injury During Emergency PCI ,
the overall incidence of thrombotic events during PCI is 7.7%, necessitating
the use of antithrombotic agents for both prophylaxis and therapeutic
management. This has driven the expanded application of antithrombotic
therapies in the field of interventional cardiology and contributed to the
growth of their market demand.
• Innovative Drug Targets and Mechanisms. Thrombosis involves complex
interactions among the coagulation system including thrombin, platelet
activation including GPIIb/IIIa receptor and P2Y
12 receptor, and the
fibrinolytic system. Given that single-target agents struggle to
comprehensively address all pathological procedures, dual-target and
multi-mechanism drugs have emerged as hotspots in drug development. For
instance, bifunctional antagonists simultaneously target both coagulation and
platelet function such as dual-target agents against factor II and GPIIb/IIIa,
along with innovative therapeutics combining anticoagulant and
anti-inflammatory effects, represent key future directions in antithrombotic
drug innovation.
Competitive landscape of PCI drugs
PCI drugs are primarily used in patients with ACS who are scheduled to undergo
PCI. As of the latest practicable date, there were three drugs with an indication for PCI
approved by NMPA and three drugs with an indication for PCI approved by FDA.
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Global competitive landscape of PCI drugs
Target Drug Name Regulatory
Authorities Approval dateIndication
GPIIb/IIIa Bevifibatide BetagrinB io-Thera • Perioperative antithrombotic
therapy for PCI
• Adjunct to PCI
• ACS patients who are
scheduled to undergo PCI
• Patients undergoing PCI
• Patients undergoing
PTCA or PCI
• HIT; Adult patients with or at
risk for HIT undergoing PCI
NMPA 2024-06-25
P2RY12 Cangrelor Kengreal CHIESI FDA 2015-06-22
GPIIb/IIIa Eptifibatide* NA
Hansoh
Pharmaceutical
etc.
NMPA 2012-10-30
Thrombin Argatroban Argatroban Plano
Pharmaceuticals FDA 2011-05-09
NA
Salubris
Pharmaceuticals
etc.
NMPA 2011-01-01
ThrombinB ivalirudin*
Angiomax Sandoz FDA 2000-12-15
Brand Name Company
*Abbreviations: HIT = heparin-induced thrombocytopenia; PTCA = Percutaneous Transluminal
Coronary Angioplast
*Note: The original drug of Eptifibatide (Integrilin) discontinued manufacturing based on a supply
issue with eptifibatide, the active pharmaceutical ingredient in Integrilin. In China, eptifibatide
is only approved as a generic drug, with approved manufacturers including Hybio
Pharmaceutical Co., Ltd., Beijing SL Pharmaceutical Co., Ltd., Shenyang Shuangding
Pharmaceutical Co., Ltd., among others. Bivalirudin is only approved in China as a generic drug,
with approved manufacturers including Shenzhen Salubris Pharmaceuticals Co.,Ltd.,
Yangzijiang Pharmaceutical Group Co., Ltd., among others.
Source: NMP A, FDA, Frost & Sullivan Analysis
As of the latest practicable date, there were ten PCI drug candidates for in the
clinical stage globally.
Global Competitive Landscape of PCI Drugs Pipeline
Target Drug Code Company Indication Regulatory
Authorities Clinical Stage Latest Update
Date
GPFactor II,
GPIIb/IIIa MT1002 Shaanxi Micot
Pharmaceutical Technology
NMPA Phase II 2024-05-11
FDA Phase I 2019-08-08
P2RY12
Vicagrel Jiangsu vcare pharmaceutical FDA Phase III 2024-10-01
DT678 Beijing SL Pharmaceutical NMPA Phase II 2026-01-04
PRT060128 Portola Pharmaceuticals FDA Phase II 2023-08-08
HY-022619 Hefei medical and
Pharmaceutical NMPA Phase I 2026-01-28
CG-0255 Shanghai CureGene
Pharmaceutical NMPA Phase I 2026-03-04
Cangrelor Jiangsu Aosaikang
Pharmaceutical NMPA Phase I 2019-07-30
LIAS, LIPT1,
SLC5A6 CMX-2043 Ischemix, LLC FDA Phase II 2011-06-20
CDH5 FX06 Biopure Corporation FDA Phase II 2007-12-04
/ SBK009 Chengdu Shibeikang
Biopharmaceutical NMPA Phase I 2025-12-23
• Anticoagulation therapy and
antithrombotic therapy for ACS patients
undergoing PCI;
• ACS patients undergoing PCI with HIT
or HITT
• ACS patients undergoing PCI
• Patients with ACS undergoing PCI
• Non-urgent PCI
• Antiplatelet therapy in patients following
PCI
• Antiplatelet therapy in the perioperative
treatment of PCI in patients with ACS
• Antiplatelet therapy in the perioperative
treatment of PCI in patients with ACS
• Antithrombotic therapy in the
perioperative treatment of PCI in patients
with ACS
• Patients undergoing PCI and
Perioperative reperfusion treatment
• Ischemia reperfusion injury in patients
undergoing PCI
• Antiplatelet therapy in the perioperative
treatment of PCI in patients with ACS
*Abbreviations: HIT = heparin-induced thrombocytopenia; HITT=heparin-induced thrombocytopenia with
thrombosis
Source: ClinicalTrials.gov, CDE, Frost & Sullivan Analysis
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4. OVERVIEW OF NEUROLOGICAL DISEASES DRUG MARKET
Overview of Ischemic Stroke Market
Ischemic stroke is the most common type of stroke, accounting for about 70%-80% of
strokes. The global prevalence of ischemic stroke grew from 65.7 million in 2020 to 85.3
million in 2025, and is projected to reach 105.8 million by 2030 and 127.4 million by 2035.
In China, the prevalence of ischemic stroke grew from 18.6 million in 2020 to 23.5 million
in 2025, and is projected to reach 28.9 million by 2030 and 35.1 million by 2035. Ischemic
stoke caused by the sudden reduction or interruption of blood supply to the brain,
resulting in ischemia and hypoxia, necrosis and softening of brain tissues, and triggering
neurological dysfunction. Acute ischemic stroke should be treated promptly within the
time window, intravenous thrombolysis can be performed within 4.5 hours, and
endovascular thrombolysis can be performed within 6 hours in case of large-vessel
occlusion, and antiplatelet, plaque stabilization, etc. are required at the same time. The
use of neuroprotective agents can reduce ischemia-induced nerve cell damage and protect
brain tissue function.
Main treatment of Ischemic Stroke
The treatment of ischemic stroke is centered on restoring blood flow and preventing
recurrence, and mainly includes surgery and medication. In terms of surgery,
endovascular intervention can quickly open up occluded blood vessels, and carotid
endarterectomy is suitable for patients with severe carotid stenosis; in medication,
thrombolytic drugs are the key to restoring blood flow in the acute stage, antiplatelet and
anticoagulant drugs can prevent the enlargement or formation of blood clots, and statins,
and drugs for controlling blood pressure, glucose, and lipids are used for long-term
prevention and treatment.
However, brain cell damage brought about during cerebral ischemia and the fact
that reperfusion can make neutrophils more likely to recruit toward the ischemic area,
triggering more severe immune inflammation, can have a significant negative impact on
stroke prognosis. Neuroprotective drugs reduce necrosis and apoptosis of neuronal cells
caused by ischemia by inhibiting oxidative stress, reducing intracellular calcium
overload, and improving mitochondrial function, thereby protecting brain tissue function
and effectively improving the prognosis of patients with ischemic stroke.
Market size of neuroprotective drugs
The patient population suffering from stroke in China continues to expand. The
accelerating aging of the population, the simultaneous increase in incidence and
prevalence rates, and the trend of younger onset have laid a solid foundation for the rigid
demand for neuroprotective drugs. The nationwide construction of stroke centers and the
implementation of the hierarchical medical system have significantly improved the
diagnosis rate and standardized treatment rate of stroke at primary medical institutions,
releasing a large amount of potential demand for medication. Core neuroprotective drugs
have been included in the NRDL, which has greatly reduced the financial burden on
patients and enhanced clinical accessibility and penetration rates. The launch of
multi-target innovative drugs and optimized dosage forms has enriched clinical treatment
options and extended the medication cycle for patients. Meanwhile, the growing
popularity of stroke rehabilitation concepts has promoted the expansion of drug
application scenarios from the traditional acute phase to the recovery phase and
home-based treatment, all of which are driving the steady growth of China’s
neuroprotective drug market.
In 2025, the neuroprotective drugs market in China reached RMB11.7 billion. It is
estimated that the market will expand to RMB15.7 billion in 2030 and 24.6 billion in 2035,
representing a CAGR of 6.2% from 2025 to 2030 and 9.3% from 2030 to 2035.
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Neuroprotective drugs market in China, 2020-2035
2020
7.6
2021 2022 2023 2024 2025 2026E 2027E 2028E 2029E 2030E 2031E 2032E 2033E 2034E 2035E
11.0 11.0 11.5 11.7 12.2 13.2 13.9 14.9 15.7 16.9 18.4 20.4 22.3 24.6
9.0
Billion RMB
Period
2020-2025 8.8%
CAGR
2025-2030E 6.2%
2030E-2035E9 .3%
Source: Annual Reports of Listed Companies, Expert Interviews, Frost & Sullivan Report
Market drivers and future trends of neuroprotective drugs market
• Unmet clinical needs. Influenced by the aging population and changes in
lifestyle, the incidence of neurological diseases represented by stroke has
increased significantly, and Alzheimer’s disease and Parkinson’s disease have
also shown a high prevalence. According to the Panorama of the Burden of
Neurological Diseases in China: A National and Provincial-Level Disease Burden
Study (1990-2021), 16 types of neurological diseases affect 468 million people
in China.
• Clinical application scenarios continue to expand. The clinical application
scenarios of neuroprotective drugs continue to broaden, extending from
traditional indications to multiple fields. In the field of acute cerebrovascular
disease, the application scenarios have been expanded from the acute stage to
pre-hospital emergency and recovery management. In the field of
neurodegenerative diseases, relevant drugs are included in medical insurance
as adjuvant therapy. Meanwhile, its application in the field of rare diseases
has made breakthroughs, and gene-targeted neuroprotection cases have
emerged.
• Accelerated development of drugs with new mechanisms. The mechanism of
action of neuroprotective drugs has evolved from single target to
multi-pathway synergy, and TrKB receptor agonists have shown potential in
protection against neurological impairment in the brain. Preclinical data
demonstrate that TrKB receptor agonists possess more than 40 times stronger
free radical-scavenging activity than first-line drugs, and exert a significant
therapeutic effect on cerebral ischemia-reperfusion injury.
Competitive landscape of neuroprotective drugs
As of the latest practicable date, there are three neuroprotective drugs approved by
NMPA.
Competitive landscape of neuroprotective drugs approved by NMPA, China
Target Drug Name Brand Name Company Indication NMPA
Approval Date
/ Edaravone and
Dexborneol ΋̀อ Simcere
Pharmaceutical
Neuroprotection in acute
ischemic stroke 2020-7-29
Bradykinin B2
receptor
Urinary
Kallidinogenase ௱ɢੰ Tianpu Biochemical
Pharmaceutical
Mild and moderate acute
ischemic stroke 2005-6-28
/B utylphthalide Enbipu CSPC Neuroprotection in acute
ischemic stroke 2002-9-30
Note: Excludes drugs included in the National Key Monitoring List for Rational Drug Use.
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As of the latest practicable date, there are 12 neuroprotective drug candidates for
neuroprotection in acute ischemic stroke in the clinical stage in China.
Competitive landscape of neuroprotective drug pipelines in China
Target Drug Code Company Clinical Stage Latest update date
Nitrone Triazine injectionNRF2, mTOR, AMPK Guangzhou magpie Pharmaceuticals Phase III 2023-12-18
Y-6 sublingual tabletPDE3 Neurodawn Pharmaceutical Phase III 2025-06-03
piragrel sodiumThromboxane A2 synthase Hefei Institute of Pharmaceutical Industry Phase III 2023-08-31
SalfaprodilGRIN Zhejiang Apeloa Medical Phase III 2022-01-01
MT200605TrKB Shaanxi Micot Pharmaceutical Technology Phase II 2025-10-21
AndrotriolGRIN Guangzhou Saipute Medicine Phase II 2025-06-18
ZKLJ02FXII, KLK Zhongke Longjin Biotechnology Phase I 2025-12-08
hNPC-01/ Hopstem Biotechnology Phase I 2024-01-08
HY0721/ Suzhou Pharmavan Natural & Health Phase I 2021-12-11
GD-11/J iangsu Vanguard Pharmaceutical Phase I 2025-09-02
XY0507Thromboxane A2 synthase Nanjing Xiangyuan Biomedical Technology Phase I 2025-05-21
Source: NMP A, CDE, Frost & Sullivan analysis
Source of Industry Information
In connection with this Global Offering, we have engaged Frost & Sullivan to
conduct a detailed analysis of our market and prepare an industry report. Frost &
Sullivan, founded in 1961 and based in the United States, is an independent global market
research and consulting firm. The company provides services including market
assessment, competitive landscape analysis, and strategic and market planning for
multiple industries. We have included excerpts from the Frost & Sullivan Report in this
Prospectus as we believe such information will assist potential investors in understanding
our market environment.
The Frost & Sullivan Report was prepared by Frost & Sullivan based on its internal
databases, independent third party reports, and publicly available information from
authoritative industry organizations. Frost & Sullivan believes that the fundamental
assumptions (including those used for future forecasts) adopted in preparing the Frost &
Sullivan Report are factual, accurate, and not misleading. We have agreed to pay Frost &
Sullivan a fee of RMB560,000 for preparing the Frost & Sullivan Report. This payment is
not conditional upon the success of our Listing or the contents of the Frost & Sullivan
Report.
Other than the Frost & Sullivan Report, we have not commissioned any other
industry report in connection with this Global Offering. Our Directors confirm that, upon
reasonable and prudent care, there have been no material adverse changes in the overall
market information since the date of the Frost & Sullivan Report that would materially
qualify, contradict or affect such information.
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We are subject to a variety of PRC laws, rules and regulations affecting many aspects
of our business. This section summarizes the major PRC regulatory authorities and PRC
laws and regulations that we believe are relevant to our business and operations in the
PRC.
PRINCIPAL REGULATORY AUTHORITIES
NMPA and Center for Drug Evaluation
National Medical Products Administration (္ຖ၍ଣ҅) (formerly known
as the China Food and Drug Administration (္ຖ၍ଣᐼ҅ ) (the “CFDA”))
(the “NMPA”) is the department in charge of the pharmaceutical industry of China. It is
primarily responsible for supervision and management of safety of pharmaceuticals,
medical devices and cosmetics, including drawing up the relevant laws and regulations;
conducting standard management, registration management, quality management and
post-market risk management for drugs, medical devices and cosmetics; and organizing
and guiding the supervision and inspection of drugs, medical devices and cosmetics and
etc.
Center for Drug Evaluation, NMPA (ᄲ൙ʕː ) (the “CDE”)
is the technical evaluation unit for drug registration with NMPA. It is primarily
responsible for conducting technical evaluation on the drugs application for registration
and verifying the relevant drug registrations.
NHC
The National Health Commission (ึ) (formerly known as the
National Health and Family Planning Commission (ึ)) (the
“NHC”), is primary national regulator for national public health and medical system.
It is primarily responsible for drafting national health policies, supervising and
regulating public health, healthcare services, and health emergency systems, coordinating
the reform of medical and health system, organizing the formulation of national drug
policies and national essential medicine system, launching an early warning mechanism
for the monitoring of the use and clinical comprehensive evaluation of medicine as well as
the drug shortage, giving suggestions on the pricing policy of national essential medicine,
and regulating the operation of medical institutions and practicing of medical personnel.
NHSA
The National Healthcare Security Administration (ღ҅) (the “NHSA”), a
new authority established in May 2018, is directly under the State Council and responsible
for the management of the healthcare security system.It is primarily responsible for
drafting and implementing policies and standards on medical insurance, maternity
insurance and medical assistance; supervising and administering the healthcare security
funds; organizing the formulation of a uniform medical insurance catalogue and payment
standards on drugs, medical disposables and healthcare services; and formulating and
supervising the implementation of the bidding and tendering policies for drugs and
medical disposables.
PRINCIPAL REGULATORY PROVISIONS
Laws and Regulations on New Drugs
Research and development of new drugs
The Drug Administration Law of the PRC () (the “Drug
Administration Law ”) promulgated by the Standing Committee of the National People’s
Congress (the “SCNPC”) in September 1984, last amended on August 26, 2019 and became
effective on December 1, 2019, and the Implementation Regulations of the Drug
Administration Law of the PRC (ૢԷ ) (the
“Implementation Regulations ”) promulgated by the State Council in August 2002 and
last amended on December 6, 2024 and became effective on January 20, 2025, have laid
down the legal framework for the establishment and maintenance of pharmaceutical
manufacturing and trading enterprises, as well as for the administration of
pharmaceutical products including the development and manufacturing of new drugs.
According to the Drug Administration Law and the Implementation Regulations, the PRC
encourages the R&D of new drugs, and protects the legal rights and interests in the R&D
of new drugs. The developer and clinical trial applicant of any new drug shall truthfully
submit the new drug’s manufacturing method, quality specifications, results of
pharmacological and toxicological tests and the related data, documents and samples to
the NMPA for approval before any clinical trial is conducted.
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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 the Opinions on Deepening the Reform of the Evaluation and
Approval Systems and Encouraging Innovation on Drugs and Medical Devices (ଉʷ
จԈ ) (the “Innovation Opinions”) on 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.
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 CFDA and became into effective on
September 1, 2017. In April 2007, the CFDA issued the Circular on Measures for
Certification of Good Laboratory Practice ( ),
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.
Animal Testing
According to the Regulations for the Regulation on Administration of Experimental
Animals (၍ଣૢԷ ) issued by the State Scientific and Technological
Commission on November 14, 1988 and last amended by the State Council on March 1,
2017, the Administrative Measures on Good Practice of Experimental Animals (ي
) jointly issued by the State Scientific and Technological Commission and
the State Bureau of Quality and Technical Supervision on December 11, 1997 and the
Administrative Measures on the Certificate for Experimental Animals (Trial) (஢
༊Б) issued by the Ministry of Science and Technology and other
regulatory authorities on December 5, 2001 and effective from January 1, 2002, using,
breeding, providing, transporting experimental animals shall be subject to some rules and
requirements, and performing experimentation on animals requires a Certificate for Use
of Experimental Animals.
Application for clinical trial
According to the Decision on Adjusting the Approval Procedures of Certain
Administrative Approval Items for Drugs (Ӕ
) promulgated by the CFDA on March 17, 2017, the decision on the approval of clinical
trials of drugs shall be made by the CDE from May 1, 2017. According to the
Administrative Measures for Drug Registration () (the “Circular 27”),
which was promulgated on January 22, 2020 and took effect on July 1, 2020, drug clinical
trials shall be divided into Phase I clinical trial, Phase II clinical trial, Phase III clinical
trial, Phase IV clinical trial, and bioequivalence trial. In accordance with Circular 27 and
the Announcement on Adjusting Evaluation and Approval Procedures for Clinical Trials
for Drugs (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. According to the Announcement on Matters Related to Optimizing
the Review and Approval of Clinical Trials for Innovative Drugs (Ꮄʷ௴
ʮѓ ) promulgated by the NMPA on September 12, 2025,
the NMPA shall complete the review and approval process for qualifying innovative drug
clinical trial applications within 30 working days.
After obtaining the approval of clinical trial from the NMPA, 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 initial registration of the trial within one month after
obtaining the approval of clinical trial to obtain an exclusive trial registration number, and
then complete the subsequent information registration before the first patient is enrolled
in the trial and submit the registration for public disclosure for the first time.
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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.
Clinical trials must be conducted in accordance with the Good Clinical Practice for
Drug Trials (ᑗґ༊᜕ሯඎ၍ଣ஝ᇍ) 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 Announcement on Adjusting Evaluation and Approval Procedures
for Clinical Trials for Drugs (ʮѓ ), where the
application for clinical trial of new drug has been approved, upon the completion of
Phases I and II clinical trials and prior to Phase III 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 III 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 R&D 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 R&D of breakthrough therapeutic drugs. Type II
meetings are held during the key R&D stages of drugs, mainly including meetings before
submitting the clinical trial application, meetings upon the completion of Phase II trials
and prior to Phase III trials and meetings before submitting the marketing application for
a new drug. Type III meetings refer to other meetings not classified as Type I or Type II.
According to the Announcement on Matters Concerning the Optimization of Drug
Registration Review and Approval (ʮѓ) jointly
issued by the NMPA and the NHC on May 17, 2018, the 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.
New drug registration
Pursuant to Circular 27, 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 sold in the China market.
According to Circular 27, the holders of any of the following drugs can apply for
conditional approval of such drugs: (1) drugs which are used for the treatment of severe
life-threatening diseases currently lacking effective treatment and the data of clinical
trials can confirm their efficacy and forecast their clinical value; (2) drugs which are
urgently needed for public health and data of clinical trials can demonstrate their efficacy
and forecast their clinical value; and (3) vaccines which are urgently needed to deal with
major public health emergencies or other vaccines which the NHC deems to be urgently
needed, the benefits of both of which are assessed to be outweigh the risk.
Pursuant to the Reform Plan for Registration Category of Chemical Medicine ( ʷኪ
) issued by the CFDA on March 4, 2016, new registration of
chemical drugs are divided into 5 categories: (i) Category 1: innovative drugs that have
not been marketed in the PRC or abroad which shall contain new compounds with clear
structure and pharmacological effects and clinical value; (ii) Category 2: improved new
drugs that have not been marketed in the PRC or abroad with optimization in structure,
dosage form, prescription technology, route of drug administration and indications on the
basis of known active ingredients as well as obvious clinical advantages; (iii) Category 3:
drugs imitated by domestic applicants which are marketed overseas while originator’s
drugs are not marketed in the PRC. Such drugs should possess quality and efficacy in line
with that of the originator’s drugs (i.e. the first drugs approved to be marketed in the PRC
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or overseas with complete and sufficient safety and efficacy data to serve as the basis for
its launch); (iv) Category 4: drugs imitated by domestic applicants while originator’s
drugs have been marketed in the PRC. The quality and efficacy of such drugs should be
consistent with that of the originator’s drugs; and (v) Category 5: drugs which have been
marketed abroad with the applications to be marketed in the PRC. Among them, the
reporting procedure for Category 1 and 2 shall comply with those for new drugs and for
Category 3 and 4 it shall be in accordance with those for generic drugs, while Category 5
shall be reported pursuant to the procedures for imported drugs.
According to the Registration Classification of Chemical Drugs and the Reporting
Information Requirements (Ӌ ) issued by the NMPA on
June 29, 2020 with implementation of the Registration Classification of Chemical Drugs
from July 1, 2020, the registration of chemical drugs is categorized into innovative drugs,
improved new drugs, generic drugs, and chemical drugs marketed abroad only.
Accelerated Approval for Clinical Trial and New Drug Registration
The Opinions of the State Council on the Reform of Evaluation and Approval
System for Drugs and Medical Devices (จ
Ԉ) issued by the State Council on August 9, 2015, established a reform framework of the
evaluation and approval system for drugs and medical devices, and specified the tasks of
enhancing the standards of approval for, among others, drug registration, accelerating the
evaluation and approval process for innovative drugs, and improving the approval for
clinical trials of drugs.
The Announcement on Several Policies on Drug Registration Review and
Approval (ʮѓ ) issued by the CFDA on November 11,
2015, provided fast-track clinical trial approvals and drug registration pathways for the
following new drug applications: (i) registration of innovative new drugs treating HIV ,
malignant tumors (cancers), severe infectious diseases and rare diseases; (ii) registration
of pediatric drugs; (iii) registration of geriatric drugs and drugs treating diseases specially
or commonly contracted by the senior population; (iv) registration of drugs listed in
national major science and technology projects or national key R&D plan; (v) registration
of innovative drugs using advanced technology or innovative treatment methods, or
having distinctive clinical benefits; (vi) registration of foreign innovative drugs to be
manufactured locally in China; (vii) concurrent applications for new drug clinical trials
which are already approved in the United States or the European Union or concurrent
drug registration applications for drugs which have applied to the competent drug
approval authorities for marketing authorization and passed such authorities’ onsite
inspections in the United States or European Union and are manufactured using the same
production line in China; and (viii) clinical trial applications for drugs with urgent clinical
need and patent expiry within three years, and manufacturing authorization applications
for drugs with urgent clinical need and patent expiry within one year.
On October 8, 2017, the General Office of the Central Committee of the Communist
Party of China and the General Office of the State Council jointly issued the Opinions on
Deepening the Reform of the Evaluation and Approval System and Encouraging
Innovation of Drugs and Medical Devices (ᔼᐕኜ૛
จԈ), aiming to simplify the clinical trial procedures and shorten the time.
Furthermore, according to the Announcement on Matters Concerning the
Optimization of Drug Registration Review and Approval (ൗ̅ᄲ൙ᄲҭϞ
ʮѓ) jointly issued by the NMPA and the NHC on May 17, 2018, the drug
approval process shall be further streamlined and expedited.
Pursuant to the provisions of the Procedures for the Evaluation of Breakthrough
Therapeutic Drugs (Trial) (ᄲ൙ʈЪ೻ҏ ༊Б) issued by the NMPA on
July 7, 2020, during the clinical drug trials, the applicant is allowed to apply for the
breakthrough therapeutic drug procedure during Phase I and Phase II clinical trials and
normally no later than the commencement of Phase III clinical trials for the innovative or
improved drugs etc. which are used for the prevention and treatment of diseases that
seriously endanger life or seriously affect quality of life and there is no effective means of
prevention and treatment or there is sufficient evidence to show a significant clinical
advantage over existing treatment approach.
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Marketing Authorization Holder Mechanism
Pursuant to the Drug Administration Law, China implements the marketing
authorization holder mechanism for management of the drug industry. 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.
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.
Laws and Regulations on Gathering, Collection and Filing of Human Genetic
Resources
On June 10, 1998, the Ministry of Science and Technology (the “MOST”) and the
Ministry of Health (the “MOH”, which was canceled in the institutional reform of the
State Council in 2013, its functions were first inherited by the National Health and Family
Planning Commission and then by the NHC, which was established in 2018) promulgated
the Interim Measures for the Management of Human Genetic Resources ( ɛᗳ፲ෂ༟๕၍
), which sets out rules for the protection and use of human genetic resources
in China. Pursuant to the Service Guide for Administrative Licensing of Gathering,
Collection, Deal, Export and Exit Approval of Human Genetic Resources of Human
genetic resources ()
promulgated by the MOST on July 2, 2015 and the Notice on the Implementation of the
Administrative License for the Gathering, Collection, Deal, Export and Exit of Human
Genetic Resources ( )
promulgated by the MOST on August 24, 2015, the gathering and collection of human
genetic resources though clinical trials by a foreign-invested sponsor shall be filed for
record with the China Human Genetic Resources Management Office through an online
system. The Ministry of Science and Technology promulgated the Circular on Optimizing
the Administrative Examination and Approval of Human Genetic Resources (Ꮄʷɛ
 ) on October 26, 2017, which became effective on
December 1, 2017, simplifying the approval of sampling and collecting human genetic
resources for the purpose of marketing a drug in the PRC.
Pursuant to the Regulations on the Management of Human Genetic Resources of the
PRC (ʕശɛ͏΍ձ਷ɛᗳ፲ෂ༟๕၍ଣૢԷ ), last amended by the State Council on
March 10, 2024 and came into effect on May 1, 2024, the State supports the rational use of
human genetic resources for scientific research, development of the biomedical industry,
improvement of diagnosis and treatment technology, improvement of China’s ability to
guarantee biosafety and improvement of the level of people’s health. Foreign
organizations, individuals and institutions established or actually controlled by them
shall not gather or preserve Chinese genetic resources in China, or provide Chinese
genetic resources to foreign countries. In addition, the gathering, preservation, utilization
and external provision of Chinese genetic resources shall conform to ethical principles
and conduct ethical review in accordance with relevant regulations. The Implementing
Rules of the Regulation on the Administration of Human Genetic Resources ( ɛᗳ፲ෂ༟
), which was promulgated by the MOST on May 26, 2023 and became
effective on July 1, 2023, further provides specific requirements on the collection,
preservation, utilization and external provision of China’s human genetic resources.
The Biosecurity Law of the PRC () (the “Biosecurity
Law”), which was promulgated by SCNPC on October 17, 2020 and last amended on April
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26, 2024, establishes a comprehensive legislative framework for the pre-existing
regulations in such areas as epidemic control of infectious diseases for humans, animals
and plants, research, development, and application of biology technology, biosecurity
management of pathogenic microbial laboratories, security management of human
genetic resources and biological resources, countermeasures for microbial resistance, and
prevention of bioterrorism and defending threats of biological weapons. According to the
Biosecurity Law, the R&D activities of high-risk and medium-risk biotechnology shall be
carried out by a legal person organization established within the territory of the PRC in
accordance with the law, upon obtaining the approval or record-filing. The following
activities are subject to approval of the competent health department: (i) collecting human
genetic resources of important genetic families or specific areas in the PRC, or collecting
human genetic resources of which the types and quantities are subject to provisions of the
competent health department under the State Council, (ii) preserving China’s human
genetic resources, (iii) using China’s human genetic resources to carry out international
scientific research cooperation, or (iv) transporting, mailing, and carrying China’s human
genetic resource materials out of the country.
Laws and Regulations on the Manufacturing of Drugs
Drug Manufacturing Certificate
Pursuant to the Drug Administration Law and the Implementing Regulations, a
drug manufacturer must obtain a Drug Manufacturing Certificate (͛ପ஢̙ᗇ) from
the drug regulatory authority at provincial, autonomous regional or municipal level
before it may start manufacturing drugs in the PRC. The Drug Manufacturing Certificate
shall indicate the validity period and the scope of production. Each Drug Manufacturing
Certificate is valid for a period of five years and the manufacturer is required to apply for
renewal of the permit within six months prior to its expiration date.
Contract manufacturing of drugs
Pursuant to the Administrative Regulations for the Contract Manufacturing of
Drugs () (the “Contract Manufacturing Regulations”) issued
by the CFDA in August 2014, only when a drug manufacturer temporarily lacks
manufacturing conditions due to technology upgrade or is unable to ensure market
supply due to insufficient manufacturing capabilities, can such drug manufacturer
entrust the manufacturing of the drug to another domestic drug manufacturer. Such
contract manufacturing arrangements shall be approved by the provincial branch of the
NMPA.
The Administrative Measures on Supervision of Drug Manufacturing (͛ପ္
) (the “Revised Administrative Measures of Drug Manufacturing”)
promulgated by the State Administration for Market Regulation on January 22, 2020 and
effective on July 1, 2020 further implements the drug marketing authorization holder
system as stipulated in the Drug Administration Law. Drug marketing authorization
holders entrusting others to manufacture drugs shall enter into outsourcing agreements
and quality agreements with qualified drug manufacturing enterprises and submit the
relevant agreements together with the actual manufacturing site application materials to
the competent drug administrative authority in order to apply for the Drug
Manufacturing Certificate.
Drug Operation License
According to the Drug Administration Law, the Measures for the Supervision and
Administration of Drug Quality in Operation and Usage (຾ᐄձԴ͜ሯඎ္ຖ၍ଣ፬
), which was issued by the SAMR on September 27, 2023 and came into effect on
January 1, 2024, whoever engages in the wholesale or retail of drugs shall be subject to the
approval of the drug regulatory authority, obtain a Drug Operation License in accordance
with the law. The drug marketing authorization holders may sell the drugs for which they
have obtained drug registration certificate on their own or entrust a drug operating
enterprise with the sale of such drugs. However, the drug marketing authorization
holders engaged in retail activities of drugs shall obtain a Drug Operation License. Each
Drug Operation License is valid for five years. Where it is necessary to continue the
operation of drugs upon the expiration of the period of validity of the Drug Operation
License, a drug operating enterprise shall file an application with the license-issuing
organ for re-examination and issuance of license in 6 to 2 months before the expiration of
the period of validity.
Laws and Regulations on Drug Supply
Drug Purchases by Hospitals
According to the Opinion on the Guidance of the Reform of Urban Medical and
Health Care System (ኬจԈ ) promulgated and took into
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effect on February 16, 2000 and the Opinion on the Implementation of Classification
Management of Urban Medical Institutions (จԈ )
promulgated on July 18, 2000 and became effective from September 1, 2000, a medical
institution must be defined as a profit-making or non-profit-making institution at the time
when it is established. A non-profit-making medical institution is established to provide
services to the general public, with its revenue used for maintaining and developing such
institution, while a profit-making medical institution is established by investors for the
purpose of investment return. The PRC government does not establish any profit-making
medical institutions, while non-government entities may establish profit-making medical
institutions. Any non-profit-making medical institutions must implement a collective
tender system in respect of any drug purchases and any profit-making medical
institutions need not to implement such a system according to PRC law.
According to the Notice on the Trial Implementation of the Centralized Tender with
Respect to Drug Purchases by Medical Institutions (ᅺમᒅ༊
) promulgated and became effective on July 7, 2000, the Notice on the
Further Standardizing of the Centralized Tender with respect to Drug Purchases By Medical
Institutions ( ) promulgated and
became effective on July 23, 2001 and the Opinions concerning Further Regulating
Purchase of Medicines by Medical Institutions through Centralized Tendering ( ආɓӉ஝
จԈ ) promulgated and took into effect on January 17,
2009, any non-profit-making medical institutions established and/or controlled by any
government at a county level or above must implement the centralized tender system in
respect of purchase of any drugs which are contained in the Medicines List for National
Basic Medical Insurance and are generally used for clinical purposes and purchased in
relatively large amount.
The Circular on the Good Practice of Medical Institutions with respect to
Centralized Procurement of Drugs (ණʕમᒅʈЪ஝ᇍ ) promulgated and
was effective on July 7, 2010, provides stipulations in detail in respect of the catalog for
centralized procurement and methods, procedures, evaluators, expert database
construction and management of drugs, further regulating the centralized drug
procurement and clarifying the code of conduct on the part of purchasing parties.
According to the Good Practice of Medical Institutions with respect to Centralized
Procurement of Drugs, any non-profit-making medical institutions established by the
government at the county level or above or state-owned enterprises (including
stock-holding enterprises) must participate in the centralized procurement of medical
institutions. The centralized procurement management authority at provincial (municipal
or district) level is responsible for compiling the catalog of drugs for centralized
procurement by medical institutions within its own administrative region, and narcotic
drugs and first class psychoactive drugs with respect to which the special administration
is carried out by the state are not included in such catalog for centralized procurement;
second class psychoactive drugs, radioactive pharmaceuticals, toxic drugs for medical
use, crude drugs, traditional Chinese medicinal materials and traditional Chinese
medicine decoction pieces may be excluded from such catalog for centralized
procurement.
According to the Guidance Opinion of the General Office of the State Council on the
Improvement of the Drug Centralized Procurement Work of Public Hospitals ( ਷ਕ৫፬
ኬจԈ ) promulgated and came into effect on
February 9, 2015, the centralized procurement work of public hospitals will be improved
through the classification purchase of drugs. All drugs used by public hospitals (with the
exception of traditional Chinese medicine decoction pieces) should be procured through a
provincial centralized pharmaceutical procurement platform. The provincial procurement
agency should work out a summary of the procurement plans and budget submitted by
hospitals and compile reasonably a drug procurement catalog of the hospitals with its
own administration region, listing by classification the drugs to be procured through bids,
negotiations, direct purchases by hospitals or to be manufactured by appointed
manufacturers.
According to the Opinions of the General Office of the State Council on Further
Reform and Improvement of Policy on Drug Production, Circulation and Use ( ਷ਕ৫፬
ʍจԈ ) promulgated by the General
Office of the State Council on January 24, 2017, cross-regional and specialized hospitals
are encouraged to make joint purchases; in areas where the reform of the payment method
of health insurance is comprehensively implemented or where the payment standard for
drugs under health insurance has already been formulated, public hospitals are allowed
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to jointly carry out volume- and budget-based procurement on the provincial centralized
drug procurement platform (the provincial public resources trading platform).
According to the Pilot Program of the Centralized Procurement and Use of Drugs
Organized by the State ( ) issued by the General
Office of the State Council on January 1, 2019, eleven pilot cities including Beijing, Tianjin,
Shanghai, Chongqing, Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu and
Xi’an, are selected to launch pilot programs of the centralized procurement and use of
drugs under the organization of the State. According to the Implementation Opinions on
Expanding the Regional Scope in the Pilot Program of Centralized Drug Procurement and
Use Organized by the State (จ
Ԉ) issued by the National Healthcare Security Administration and other departments on
September 25, 2019, the regional scope in the pilot program of centralized procurement
and use of drugs organized by the State is being expanded and the volume-based
procurement model of the pilot program for conducting the centralized procurement and
use of drugs organized by the State is being promoted throughout the country.
The Opinions of the General Office of the State Council on Promoting the
Centralized Volume-based Procurement of Drugs in a Normalized and Institutionalized
Manner (จԈ ), which
was promulgated by the General Office of the State Council on January 22, 2021, set out
the promotion of the normalization and institutionalization of the centralized
procurement of drugs. All public medical institutions (including military medical
institutions, hereinafter referred to as the same) shall participate in the centralized
procurement of drugs, with reference to the requirements of the management of
designated social medical institutions and designated pharmacies in accordance with the
management of designated agreements for medical insurance. In accordance with the
principles of preserving the basics and the clinical care, emphasis shall be placed on
including drugs that are listed in the Drug Catalogue of Basic Medical Insurance with
large consumption and high procurement price in the procurement scope, and gradually
covering various drugs which are clinically necessary and reliable, so as to achieve the
procurement of all medicines as much as possible.
Drug Price Management
Pursuant to the Opinions on Promoting Drug Pricing Reform (ٙࠧ
จԈ), which was jointly promulgated by the authorities including the NDRC on May 4,
2015, from June 1, 2015, the original prices of the drugs formulated by the government will
be canceled, except for narcotic drugs and Class I psychotropic drugs. The prices of
narcotic drugs and Class I psychotropic drugs are still temporarily managed by the NDRC
through the implementation of maximum factory prices and maximum retail prices. The
drugs other than the narcotic drugs and Class I psychotropic drugs no longer adopted
government-designated pricing. Such notice aimed to improve the mechanism of the drug
purchase, give play to the role of health care insurance in drug fees controlling, and actual
transaction prices of the drugs are mainly determined by the market competition.
Two-invoice System
In order to further optimize the order of purchasing and selling pharmaceutical
products and reduce circulation steps, as required at the executive meeting of the State
Council dated April 6, 2016 and under the 2016 List of Major Tasks in Furtherance of the
Healthcare and Pharmaceutical Reforms (ࠧ2016ᓃʈЪ΂ਕ)
issued by the General Office of the State Council on April 21, 2016, the “two-invoice
System” (ՇୃՓ) will be fully implemented in the PRC. According to the Circular on
Issuing the Implementing Opinions on Carrying out the Two-invoice System for Drug
Procurement among Public Medical Institutions (for Trial Implementation) (ί
) (the “Circular”), which
was effective from December 26, 2016, the two-invoice system means one invoice between
the pharmaceutical manufacturer and the pharmaceutical distributor, and one invoice
between the pharmaceutical distributor and the hospital, and thereby only allows a single
level of distributor for the sale of pharmaceutical products from the pharmaceutical
manufacturer to the hospital. According to the Circular, two-invoice system will be
promoted in pilot provinces (autonomous regions and municipalities directly under the
Central Government) involved in the comprehensive medical reform program and pilot
cities for public hospital reform on a priority basis, while other regions are encouraged to
implement such system, so that such system can be promoted in full swing nationwide in
2018.
Commercial Briberies in Pharmaceutical Industry
According to the Anti-Unfair Competition Law of the People’s Republic of China ( ʕശ
), as amended on 27 June 2025 and implemented on 15 October
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2025, promulgated by the Standing Committee of the National People’s Congress,
operators shall not bribe the following entities or individuals by means of offering money
or other benefits in order to seek out transactional opportunities or competitive
advantages: (i) Staff members of the counterparty to the transaction; (ii) Entities or
individuals entrusted by the counterparty to handle relevant affairs; and (iii) Entities or
individuals who may influence transactions through their authority or influence.
Pursuant to the Provisional Regulations on Prohibiting Commercial Bribery (ຫ˟ਠ
) issued by the former State Administration for Industry and
Commerce on 15 November 1996, commercial bribery is defined as the offering of
financial and material assets or other means by an operator to another organization or
individual with the aim of influencing the sale or purchase of goods.
According to the Provisions on the Establishment of Adverse Records of
Commercial Briberies in the Medicine Purchase and Sales Industry (ͭᔼᖹᒅቖჯ
), which was promulgated by the National Health and Family
Planning Commission (currently the NHC) and came into effect on March 1, 2014, an
enterprise engaged in the manufacturing or distribution of medicines, medical devices or
medical consumables (or its agent) that offers any items of value or other benefits to the
staff of a medical institution may be listed in the Adverse Records of Commercial Bribery
(“Adverse Records”) by the relevant government authorities. As a result, its products
cannot be purchased by public medical institutions or medical and health institutions
receiving financial subsidies within the relevant provinces, and the scores of its products
in the centralized procurement processes conducted by public medical institutions or
medical and health institutions receiving financial subsidies in other provinces will be
reduced. Where the relevant enterprise (or its agent) is listed in Adverse Records twice
within a five-year period, its products cannot be purchased by public medical institutions
or medical and health institutions receiving financial subsidies across China for two years.
Regulations in relation to the Medical Insurance Program
Coverage of the national medical insurance program
The national medical insurance program was first adopted according to the
Decision of the State Council on the Establishment of the Urban Employee Basic Medical
Insurance Program ( ) issued by the
State Council on December 14, 1998, under which all employers in urban cities are
required to enroll their employees in the basic medical insurance program and the
insurance premium is jointly contributed by the employers and employees. On July 10,
2007, the State Council issued the Guiding Opinions of the State Council about the Pilot
Urban Resident Basic Medical Insurance (ܸٙ
ኬจԈ), further enlarged the coverage of the basic medical insurance program, under
which urban residents of the pilot district, rather than urban employees, may voluntarily
join Urban Resident Basic Medical Insurance. In addition, on January 3, 2016, the
Opinions of the State Council on Integrating the Basic Medical Insurance Systems for
Urban and Rural Residents (จԈ ) issued by
the State Council required the integration of the urban resident basic medical insurance
and the new rural cooperative medical care system and the establishment of a unified
basic medical insurance system, which will cover all urban and rural residents other than
rural migrant workers and persons in flexible employment arrangements who participate
in the basic medical insurance for urban employees.
Medical Insurance Catalogue
According to the Interim Measures for the Administration of Use of Drugs Covered
by the Basic Medical Insurance ( ) or the NRDL
Administrative Measures, which promulgated by the NHSA, on July 30, 2020 and took
effect on September 1, 2020, the scope of drugs covered by the basic medical insurance
shall be administered through a reimbursement drug list.
The National Drug Catalog for Basic Medical Insurance, Work-related Injury
Insurance and Maternity Insurance (ͦ፽ ),
or the National Reimbursement Drug List (the “NRDL”), which promulgated by the
NHSA and last amended on January 6, 2025, sets forth the payment standard for
pharmaceutical products under the basic medical insurance, work-related injury
insurance and maternity insurance funds. The local government shall strictly implement
the NRDL and shall not adjust the contents contained in the NRDL at their own discretion.
Medicines listed in the NRDL are divided into two parts, List A and List B. List A drugs are
widely used clinical treatments with good efficacy and lower prices compared to similar
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drugs, while List B drugs are clinical treatments with good efficacy and slightly higher
prices compared to List A drugs.
According to the NRDL Administrative Measures, a Provincial Reimbursement
Drug List (“PRDL”) must be made by the provincial healthcare security authorities.
Patients purchasing List A drugs can directly obtain reimbursement under the basic
medical insurance program. Patients purchasing List B drugs shall pay a certain
percentage of the purchase price first and then obtain reimbursement under the basic
medical insurance program.
National Essential Drug List
On August 18, 2009, the Ministry of Health (the “MOH”) and eight other ministries
and commissions in the PRC issued the Provisional Measures on the Administration of the
National Essential Drug List (ᅲБ), which was amended
on February 13, 2015, and the Guidelines on the Implementation of the National Essential
Drug List System (จԈ ), which aims to promote
essential medicines sold to consumers at fair prices in the PRC and ensure that the general
public in the PRC has equal access to the drugs contained in the National Essential Drug
List. The NHC promulgated the National Essential Drug List (2018) (ͦ፽
2018), the “National Essential Drug List”) on September 30, 2018, replacing the
National Essential Drug List (2012) (ͦ፽ 2012 ) which was
promulgated on March 13, 2013. According to these regulations, basic healthcare
institutions funded by government shall store up and use drugs listed in National
Essential Drug List. The drugs listed in National Essential Drug List shall be purchased by
centralized tender process and shall be subject to the price control by the National
Development and Reform Commission of the PRC (ึ
(the “NDRC”)). Remedial drugs in the National Essential Drug List are all listed in the
Medical Insurance Catalogue and the entire amount of the purchase price of such drugs is
entitled to reimbursement.
Laws and Regulations on Intellectual Properties
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 (ᗆ
), the Paris Convention for the Protection of Industrial Property (ᚐʈุପᛆˋ
), the Madrid Agreement Concerning the International Registration of Marks ( ਠᅺ਷
) and the Patent Cooperation Treaty ().
Patent
Patents in the PRC are mainly protected by the Patent Law of the PRC ( ʕശɛ͏΍
), which was promulgated by the SCNPC on March 12, 1984, last amended on
October 17, 2020 and became effective on June 1, 2021, and the Implementation Rules of
the Patent Law of the PRC ( ), which were promulgated
by the State Council on June 15, 2001, last amended on December 11, 2023 and became
effective on January 20, 2024. The Patent Law of the PRC and its Implementation Rules
provide for three types of patents, “invention”, “utility model” and “design.” “Invention”
refers to any new technical solution relating to a product, a process or improvement
thereof; “utility model” refers to any new technical solution relating to the shape,
structure, or their combination, of a product, which is suitable for practical use; and
“design” refers to any new design of the shape, pattern, color or the combination of any
two of them, of a product, which creates an aesthetic feeling and is suitable for industrial
application. The duration of a patent right for “invention” is 20 years, the duration of a
patent right for “utility model” is 10 years, and the duration of a patent right for “design”
is 15 years, from the date of application. According to the Patent Law of the PRC, for the
purpose of public health, the patent administrative department of the State Council may
grant mandatory licensing to manufacture and export patented drugs to countries or
regions in comply with provisions of the relevant international treaty participated by the
PRC.
Trade Secret
According to the Anti-Unfair Competition Law of the PRC ( ʕശɛ͏΍ձ਷ˀʔ͍
), promulgated by the SCNPC in September 1993 and subsequently amended on
November 4, 2017, April 23, 2019, June 27, 2025 and which will become effective on
October 15, 2025, 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
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Anti-Unfair Competition Law of the PRC, business persons are prohibited from infringing
others’ trade secrets by: (1) acquiring a trade secret from the right holder by theft, bribery,
fraud, coercion, electronic intrusion, or any other means; (2) disclosing, using, or allowing
another person to use a trade secret acquired from the right holder by any means as
specified in the item (1) above; (3) disclosing, using, or allowing another person use a
trade secret in its possession, in violation of its confidentiality obligation or the
requirements of the right holder for keeping the trade secret confidential; (4) abetting a
person, or tempting another person into or in acquiring, disclosing, using, or allowing
another person to use the trade secret of the right holder in violation of his or her
non-disclosure obligation of the requirements of the right holder for keeping the trade
secret confidential.
Trademark
Pursuant to the Trademark Law of the PRC () promulgated
by the SCNPC on August 23, 1982, last amended on April 23, 2019 and became effective on
November 1, 2019, the period of validity for a registered trademark is 10 years,
commencing from the date of registration. Upon expiry of the period of validity, the
registrant shall go through the formalities for renewal within twelve months prior to the
date of expiry as required if the registrant needs to continue to use the trademark. Where
the registrant fails to do so, a grace period of six months may be granted. The period of
validity for each renewal of registration is 10 years, commencing from the day
immediately after the expiry of the preceding period of validity for the trademark. In the
absence of a renewal upon expiry, the registered trademark shall be canceled. Industrial
and commercial administrative authorities have the authority to investigate any behavior
in infringement of the exclusive right under a registered trademark in accordance with the
law. In case of a suspected criminal offense, the case shall be timely referred to a judicial
authority and decided in accordance with applicable laws.
Copyright
Copyright in the PRC is primarily protected by the Copyright Law of the PRC ( ʕശɛ
), which was promulgated by the SCNPC on September 7, 1990, last
amended on November 11, 2020 and became effective on June 1, 2021, and Implementation
Regulations of the Copyright Law of PRC (ૢԷ ), which
was promulgated by the State Council on August 2, 2002 and last amended on January 30,
2013. These law and regulation provide provisions on the classification of works and the
obtaining and protection of copyright.
Domain Names
In accordance with the Measures for the Administration of Internet Domain
Names () which was issued by the Ministry of Information Industry
on August 24, 2017 and came into effect on November 1, 2017, the Ministry of Industry and
Information Technology is responsible for supervision and administration of domain
name services in the PRC. Communications administrative bureaus at provincial levels
shall conduct supervision and administration of the domain name services within their
respective administrative jurisdictions. Domain name registration services shall, in
principle, be subject to the principle of “first apply, first register.” A domain name
registrar shall, in the process of providing domain name registration services, ask the
applicant for which the registration is made to provide authentic, accurate and complete
identity information on the holder of the domain name and other domain name
registration related information.
Laws and Regulations on Labor Protection and Social Insurance
General Labor Contracts Rules
According to the Labor Law of the PRC (), which was
promulgated by the SCNPC in July 1994 and last amended and came into effect in
December 2018, the Labor Contract Law of the PRC (), which
was promulgated by the SCNPC in June 2007 and amended in December 2012 and came
into effect in July 2013, and the Implementing Regulations of the Labor Contracts Law of
the PRC (ૢԷ ), which was promulgated by the State
Council and came into effect in September 2008, labor contracts in written form shall be
executed to establish labor relationships between employers and employees. In addition,
wages shall not be lower than local minimum wages. The employers must establish a
system for labor safety and sanitation, strictly comply with national rules and standards,
provide education regarding labor safety and sanitation to its employees, provide
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employees with labor safety and sanitation conditions and necessary protection materials
in compliance with national rules, and carry out regular health examinations for
employees engaged in work involving occupational hazards.
Labor, Social Insurance and Housing Provident Funds
According to the Social Insurance Law of PRC (), which
was promulgated by the SCNPC in October 2010 and last amended and came into effect in
December 2018, and the Interim Regulations on the Collection and Payment of Social
Security Funds (ᎈ൬ᅄᖮᅲБૢԷ), which was promulgated by the State Council
in January 1999 and last amended in March 2019, and the Regulations on the
Administration of Housing Provident Funds (၍ଣૢԷ ), which was
promulgated by the State Council in April 1999 and last amended in March 2019,
employers are required to contribute, on behalf of their employees, to a number of social
security funds, including funds for basic pension insurance, unemployment insurance,
basic medical insurance, occupational injury insurance and maternity insurance and to
housing provident funds. Any employer who fails to make the required contributions may
be fined and ordered to compensate the deficit within a stipulated time limit.
On July 20, 2018, the General Office of the Communist Party of China and the
General Office of the PRC State Council jointly issued the Reform Plan of the State Tax and
Local Tax Collection Administration System (), under which,
starting from January 1, 2019, tax authorities are responsible for the collection of social
insurance contributions in China. According to the Notice on Conducting the Relevant
Work Concerning the Administration of Collection of Social Insurance Premiums in a
Steady, Or derly and Effective Manner ()
issued by the SAT in September 2018 and the Urgent Notice on Implementing the Spirit of
the Executive Meeting of the State Council in Stabilizing the Collection of Social Security
Contributions (ஷ
) issued by the General Office of the Ministry of Human Resources and Social Security
in September 2018, all the local authorities responsible for the collection of social
insurance are strictly forbidden to conduct self-collection of historical unpaid social
insurance contributions from enterprises. The Notice on Implementing Several Measures
to Further Support and Serve the Development of Private Economy (ܵ
 ) issued by the SAT in November 2018, repeats that
tax authorities at all levels may not organize self-collection of unpaid social insurance
contributions of taxpayers including private enterprises in the previous years. The Notice
on Issuing the Comprehensive Plan for the Reduction of Social Insurance Premium Rate (׵
) promulgated by the General Office of the PRC State
Council in April 2019, generally reduces the social insurance contribution burden of
enterprises, underlines that the duties for collection of social insurances premium paid by
the enterprises in any province shall not be transferred to tax authorities until the
condition of the province is mature, and re-emphasizes that local authorities shall not
conduct self collection of historical unpaid social insurance contributions from
enterprises.
According to the Interpretation (II) of the Supreme People’s Court on Issues
Concerning the Application of Law in the Trial of Labor Dispute Cases (׵
༆ᙑ ɚ), which was promulgated by the Supreme
People’s Court in July 2025 and came into effect in September 2025, an employer and an
employee conclude an agreement, or an employee promises to an employer, that there is
no need to pay social insurance premiums, such agreement or promise shall be
determined invalid; where an employer fails to pay social insurance premiums in
accordance with the law, and the relevant employee requests to terminate the labor
contract and requests for the employer to pay economic compensation, the people’s court
shall support such requests in accordance with the law. Where an employer, after making
up the social insurance contributions in accordance with the law under the circumstances
stipulated in the preceding paragraph, requests the employee to return the social
insurance compensation already paid, the people’s court shall support such request in
accordance with the law.
Prevention and Control of Occupational Diseases
The Prevention and Control of Occupational Diseases Law of the PRC ( ʕശɛ͏΍
), which was promulgated by the SCNPC on October 27, 2001 and latest
amended on December 29, 2018 (the “Prevention and Control of Occupational Diseases
Law”), is the basic law for the prevention and control of occupational diseases. According
to the Prevention and Control of Occupational Diseases Law, budget for facilities for the
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prevention and control of occupational diseases of a construction project shall be included
in the budget of the project and those facilities shall be designed, constructed and put into
operation simultaneously with the main body of the project. The entity that takes charge
of the project should carry out the assessment of the effectiveness of measures for the
prevention and control of occupational diseases before the final acceptance of the
construction project. In addition, employers shall take required administrative measures
to prevent and control occupational diseases in work.
Laws and Regulations on Leasing
On December 1, 2010, the Ministry of Housing and Urban-Rural Development
promulgated the Administrative Measures on Leasing of Commodity Housing (܊גۜ
),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 Civil Code of the PRC (Պ), the relevant
parties fail to complete property leasing registration and filing formality in accordance
with the laws and regulations, the validity of the lease is not affected.
Laws and Regulations on Environmental Protection, Health and Safety
Environment Protection
The Environmental Protection Law of the PRC () (“the
Environmental Protection Law”), which was promulgated by the SCNPC on December 26,
1989 and last amended on April 24, 2014, came into effect on January 1, 2015, outlines the
authorities and duties of various environmental protection regulatory agencies. The
Ministry of Ecology and Environment is authorized to issue national standards for
environmental quality and emissions, and to monitor the environmental protection
scheme of the PRC. Meanwhile, local environment protection authorities may formulate
local standards which are more rigorous than the national standards, in which case, the
concerned enterprises must comply with both the national standards and the local
standards.
Environmental Impact Appraisal
According to the Administration Rules on Environmental Protection of
Construction Projects (ᚐ၍ଣૢԷ), which was promulgated by the State
Council on November 29, 1998, amended on July 16, 2017 and became effective on October
1, 2017, depending on the impact of the construction project on the environment, an
construction employer shall submit an environmental impact report or an environmental
impact statement, or file a registration form. As to a construction project, for which an
environmental impact report or the environmental impact statement is required, the
construction employer shall, before the commencement of construction, submit the
environmental impact report or the environmental impact statement to the relevant
authority at the environmental protection administrative department for approval. If the
environmental impact assessment documents of the construction project have not been
examined or approved upon examination by the approval authority in accordance with
the law, the construction employer shall not commence the construction. According to the
Environmental Impact Appraisal Law of PRC ( ) (“the
Environmental Impact Appraisal Law”), which was promulgated by the SCNPC on
October 28, 2002, amended on July 2, 2016 and December 29, 2018, for any construction
projects that have an impact on the environment, an entity is required to produce either a
report, or a statement, or a registration form of such environmental impacts depending on
the seriousness of effect that may be exerted on the environment.
Completion and Acceptance
The Interim Measures for Acceptance of Environmental Protection upon
Completion of Construction Projects ( ),
promulgated and implemented by the former Ministry of Environmental Protection (now
the MEE) on November 20, 2017, regulate the procedures and standards for environmental
protection acceptance by construction entities upon the completion of construction
projects.
Fire Prevention
According to the Fire Prevention Law of the PRC ( ),
promulgated by the SCNPC on April 29, 1998 and last amended with effect from April 29,
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2021, design and construction of the fire control facilities for a construction work shall
comply with the national fire control technical standards. The developer, designer,
constructors and project supervisor of a construction project shall be responsible for the
quality of the design and construction of the fire control facilities for the construction
work according to the relevant laws. If the design of fire control of a construction project
has not been examined pursuant to the relevant laws or failed to pass the 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.
Management of Waste Discharge
Pursuant to the Catalog of Classified Management of Pollutant Discharge Permits
for Stationary Pollution Sources (2019 Version) (๕રϮ஢̙ʱᗳ၍ଣΤ፽ 2019ϋ
) issued by the Ministry of Ecology and Environment of the PRC and became effective
on December 20, 2019, the State implements the primary management, simplified
management and registration management of pollutant discharge permits based on the
pollutant production, emission amount and the extent of environmental impact of the
pollutant discharge entities. A pollutant discharge unit under registration management
does not need to apply for a pollutant discharge license.
Pursuant to the Regulations on the Administration of Pollutant Discharge Permits (રϮ
஢̙၍ଣૢԷ) promulgated by the State Council on January 24, 2021 and became effective
on March 1, 2021, based on the quantity of pollutants generated and discharged, their
impacts on the environment and other factors, categorical administration of pollutant
discharge permit system is implemented to regulate pollutant-discharging entities: (1) key
administration of pollutant discharge permits shall be implemented for pollutant
discharging entities which generate and discharge relatively large quantities of pollutants
or have a relatively serious impact on the environment; and (2) administration of
pollutant discharge permits shall be simplified for pollutant-discharging entities which
generate and discharge relatively small quantities of pollutants and have a relatively
small impact on the environment. The entities that generate and discharge relatively small
quantities of pollutants and have a relatively small impact on the environment shall fill in
the waste discharge registration form (ڌand are no longer required to obtain a
waste discharge license ( રϮ஢̙ᗇ).
Laws and Regulations on Foreign Investment
Company Law of the PRC
The Company Law of the PRC () (the “Company Law”)
which was promulgated by the Standing Committee of the NPC on December 29, 1993,
came into effect on July 1, 1994, revised on December 25,1999, August 28, 2004, October 27,
2005 and December 28, 2013, October 26, 2018, December 29, 2023 respectively and the
latest revision of which was implemented on July 1, 2024, governs the establishment,
operation and management of companies in the PRC, including foreign-invested
companies. Unless foreign investment laws provide otherwise, foreign-invested
companies shall abide by the Company Law of the PRC.
Foreign Investment
On December 30, 2019, the Ministry of Commerce and the SAMR, jointly
promulgated the Measures for Information Reporting on Foreign Investment (ڦ
), which became effective on January 1, 2020. Pursuant to the Measures for
Information Reporting on Foreign Investment, where a foreign investor carries out
investment activities in China directly or indirectly, the foreign investor or the
foreign-invested enterprise shall submit the investment information to the competent
commerce department through the enterprise registration system and the National
Enterprise Credit Information Publicity System, and the reporting methods include initial
reports, change reports, cancelation reports, and annual reports.
Laws and Regulations on Outbound Investment
Pursuant to the Administrative Measures on Outbound Investments ( ྤ̮ҳ༟၍ଣ
) issued by the MOFCOM on March 16, 2009, and amended on September 6, 2014,
and the Administrative Measures for the Outbound Investments of Enterprises ( Άุྤ̮
) issued by the NDRC on December 26, 2017, and effective from March 1,
2018, if an enterprise in the PRC intends to make outbound investments, it shall be subject
to approval or filing for the project, report relevant information, and cooperate in the
supervisory inspections. Non-sensitive projects directly conducted by domestic
REGULATORY OVERVIEW
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enterprise in China, involving direct contribution of assets or rights and interests or
provision of financing or security, shall be subject to filing.
Laws and Regulations on Foreign Exchange and T axation
Foreign Exchange
On January 29, 1996, the State Council promulgated the Administrative Regulations
on Foreign Exchange of the PRC ( ʕശɛ͏΍ձ਷̮ි၍ଣૢԷ ) which became effective
on April 1, 1996 and was amended on January 14, 1997 and August 5, 2008. Foreign
exchange payments under current account items shall, pursuant to the administrative
provisions of the foreign exchange control department of the State Council on payments of
foreign currencies and purchase of foreign currencies, be made using self-owned foreign
currency or foreign currency purchased from financial institutions engaging in conversion
and sale of foreign currencies by presenting the valid document. Domestic entities and
domestic individuals making overseas direct investments or engaging in issuance and
trading of overseas securities and derivatives shall process registration formalities
pursuant to the provisions of the foreign exchange control department of the State
Council.
On November 19, 2012, the SAFE issued the Circular of Further Improving and
Adjusting Foreign Exchange Administration Policies on Foreign Direct Investment (࢕
 ) (“the SAFE Circular 59”),
which came into effect on December 17, 2012 and was revised on May 4, 2015, October 10,
2018 and partially abolished on December 30, 2019. The SAFE Circular 59 aims to simplify
the foreign exchange procedure and promote the facilitation of investment and trade.
According to the SAFE Circular 59, the opening of various special purpose foreign
exchange accounts, such as pre-establishment expenses accounts, foreign exchange capital
accounts and guarantee accounts, the reinvestment of RMB proceeds derived by foreign
investors in the PRC, and remittance of foreign exchange profits and dividends by a
foreign-invested enterprise to its foreign shareholders no longer require the approval or
verification of SAFE, as well multiple capital accounts for the same entity may be opened
in different provinces. Later, the SAFE promulgated the Circular on Further Simplifying and
Improving Foreign Exchange Administration Policies in Respect of Direct Investment (׵
) on February 13, 2015, which was partially
abolished on December 30, 2019 and prescribed that the bank instead of SAFE can directly
handle the foreign exchange registration and approval under foreign direct investment
while SAFE and its branches indirectly supervise the foreign exchange registration and
approval under foreign direct investment through the bank.
On May 10, 2013, the SAFE issued the Administrative Provisions on Foreign
Exchange in Domestic Direct Investment by Foreign Investors (ટҳ༟
) (“the SAFE Circular 21”), which became effective on May 13, 2013,
amended on October 10, 2018 and partially abolished on December 30, 2019. The SAFE
Circular 21 specifies that the administration by SAFE or its local branches over direct
investment by foreign investors in the PRC must be conducted by way of registration and
banks must process foreign exchange business relating to the direct investment in the PRC
based on the registration information provided by SAFE and its branches.
According to the Notice of the State Administration of Foreign Exchange on Issues
Concerning the Foreign Exchange Administration of Overseas Listing (̮ි၍ଣ҅ᗫ
 ) issued by the SAFE on December 26, 2014, a
domestic company shall, within 15 business days from the date of the end of its overseas
listing issuance, register the overseas listing with the local branch office of state
administration of foreign exchange at the place of its establishment; the proceeds from an
overseas listing of a domestic company may be remitted to the domestic account or
deposited in an overseas account, but the use of the proceeds shall be consistent with the
content of the document and other disclosure documents.
According to the Notice of the State Administration of Foreign Exchange on
Reforming the Management Mode of Foreign Exchange Capital Settlement of Foreign
Investment Enterprises (ٙ
) (“the SAFE Circular 19”) promulgated on March 30, 2015, coming effective on June
1, 2015, partially abolished on December 30, 2019 and partially amended on March 23,
2023, foreign-invested enterprises could settle their foreign exchange capital on a
discretionary basis according to the actual needs of their business operations.
On June 9, 2016, SAFE issued the Notice of the State Administration of Foreign
Exchange on Reforming and Standardizing the Foreign Exchange Settlement Management
REGULATORY OVERVIEW
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Policy of Capital Account ( )
(“the SAFE Circular 16”), which came into effect on the same day and was partially
amended according to Notice of the State Administration of Foreign Exchange on Further
Deepening Reforming to Facilitate Cross-border Trade and Investment (̮ි၍ଣ҅
 ) promulgated by the SAFE on
December 4, 2023. The SAFE Circular 16 provides that discretionary foreign exchange
settlement applies to foreign exchange capital, foreign debt offering proceeds and
remitted foreign listing proceeds, and the corresponding RMB capital converted from
foreign exchange may be used to extend loans to related parties or repay inter-company
loans (including advances by third parties). However, there remain substantial
uncertainties with respect to SAFE Circular 16’s interpretation and implementation in
practice.
On October 23, 2019, SAFE promulgated the Notice on Further Facilitating
Cross-Board Trade and Investment (ٙ
), which became effective on the same date (except for Article 8.2, which became
effective on January 1, 2020) and was partially amended according to Notice of the State
Administration of Foreign Exchange on Further Deepening Reforming to Facilitate
Cross-border Trade and Investment (ҳ
) promulgated by the SAFE on December 4, 2023.
On September 15, 2025, SAFE promulgated the Notice of the State Administration of
Foreign Exchange on Matters Concerning Deepening the Reform of Foreign Exchange
Administration for Cross-Border Investment and Financing (ଉʷ༨
 ). This notice cancels the registration of basic
information on pre-investment expenses for domestic direct investment and the
registration of domestic reinvestment by foreign-invested enterprises, allows the
domestic reinvestment of foreign exchange profits under foreign direct investment,
expands cross-border financing convenience, simplifies the registration management
requirements for cross-border financing facilitation business, and reduces the negative list
for the use of income from capital projects.
Taxation
Enterprise Income Tax
The Enterprise Income Tax Law of the PRC ( ) (“the
EIT Law”), promulgated by the NPC on March 16, 2007, came into effect on January 1, 2008
and amended on February 24, 2017 and December 29, 2018, as well as the Implementation
Rules of the EIT Law (ૢԷ ) (“the Implementation
Rules”), promulgated by the State Council on December 6, 2007, came into force on
January 1, 2008 and last amended on December 6, 2024, are the principal law and
regulation governing enterprise income tax in the PRC. According to the EIT Law and its
Implementation Rules, enterprises are classified into resident enterprises and
non-resident enterprises Resident enterprises refer to enterprises that are legally
established in the PRC, or are established under foreign laws but whose actual
management bodies are located in the PRC. And non-resident enterprises refer to
enterprises that are legally established under foreign laws and have set up institutions or
sites in the PRC but with no actual management body in the PRC, or enterprises that have
not set up institutions or sites in the PRC but have derived incomes from the PRC. A
uniform income tax rate of 25% applies to all resident enterprises and non-resident
enterprises that have set up institutions or sites in the PRC to the extent that such incomes
are derived from their set-up institutions or sites in the PRC, or such income are obtained
outside the PRC but have an actual connection with the set-up institutions or sites. And
non-resident enterprises that have not set up institutions or sites in the PRC or have set up
institutions or sites but the incomes obtained by the said enterprises have no actual
connection with the set-up institutions or sites, shall pay enterprise income tax at the rate
of 10% in relation to their income sources from the PRC.
Value-Added Tax (the “VAT”)
Pursuant to the Provisional Regulations of the PRC on Value-added Tax ( ʕശɛ͏
೼ᅲБૢԷ) amended in November 2017, and the Detailed Rules for the
Implementation of the Interim Regulations of the PRC on Value-Added Taxes ( ʕശɛ͏
 ) amended in October 2011, all entities or individuals
engaged in the sale of goods, provision of processing, repair and maintenance services, or
importation of goods within China shall be value-added tax taxpayers and subject to
value-added tax in accordance with relevant laws and regulations. Thr ough the
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value-added tax reform in China, value-added tax rates have undergone multiple adjustments
and value-added tax are regulated by the Value-Added Tax Law of the PRC (ʕശɛ͏΍ձ਷ᄣ
), which was implemented in January 2026.
Laws and Regulations on Information Security and Data
Privacy Data Security and Data Export
The SCNPC promulgated the Data Security Law of the PRC ( ʕശɛ͏΍ձ਷ᅰኽτ
) on June 10, 2021, which became effective from September 1, 2021, for the
establishment of a data classification and grading protection system to conduct classified
and hierarchical protection of data. Entities engaged in data processing activities shall, in
accordance with laws and regulations, establish a sound full-process data security
management system, organize data security education and training, and take
corresponding technical measures and other necessary measures to ensure data security.
On December 28, 2021, the Cyberspace Administration of China (the “CAC”) and
other twelve PRC regulatory authorities jointly revised and promulgated the Measures for
Cybersecurity Review () (the “Cyber Review Measures”), which came
into effect on February 15, 2022. The Cyber Review Measures stipulate that, among others,
(i) when the purchase of network products and services by a critical information
infrastructures operator (the “CIIO”) (٫or the data processing
activities conducted by a network platform operator (٫affect or may affect
national security, a cybersecurity review shall be conducted pursuant to the Cyber Review
Measures; (ii) an application for cybersecurity review shall be made by an issuer who is a
network platform operator holding personal information of more than one million users
before such issuer applies to list its securities abroad; and (iii) the relevant PRC
governmental authorities may initiate cybersecurity review if such governmental
authorities determine that the issuer’s network products or services, or data processing
activities affect or may affect national security.
According to the Measures on Security Assessment of Cross-border Data Transfer (ᅰኽ
) issued by the CAC on July 7, 2022 and effective on September 1, 2022,
a data processor that provides data overseas under any of the following circumstances
shall apply to the national cyberspace administration for the security assessment of the
outbound data transfer through local provincial cyberspace administration: (i) a data
processor provides important data abroad; (ii) the CIIO or the data processor that has
processed the personal information of more than 1 million people provides personal
information abroad; (iii) the data processor that has provided the personal information of
over 100,000 people or the sensitive personal information of over 10,000 people
cumulatively since January 1 of the previous year provides personal information abroad;
and (iv) any other circumstance where an application for the security assessment of
outbound data transfer is required by the national cyberspace administration.
According to the Measures for Standard Contract for Outbound Transfer of Personal
Information () issued by the CAC on February 22, 2023 and
effective from June 1, 2023, to provide personal information to an overseas recipient
through the conclusion of the standard contract, a personal information processor shall
meet all of the following circumstances: (i) it is not a CIIO; (ii) it has processed the
personal information of less than one million individuals; (iii) it has cumulatively
provided the personal information of less than 100,000 individuals to overseas recipients
since January 1 of the previous year; and (iv) it has cumulatively provided the sensitive
personal information of less than 10,000 individuals since January 1 of the previous year.
According to the Provisions on Promoting and Regulating Cross-border Data
Flows ( ), which was promulgated by the CAC on March 22,
2024 and came into effect on the same day, if the data have not been informed or publicly
announced as important data by relevant departments or regions, data handlers are not
required to declare security assessment for cross-border provision of the data as important
data.
Personal Information Protection
According to the Civil Code of the PRC (Պ ), personal
information of natural persons is protected by law. If any organization or individual needs
to obtain other people’s personal information, they should obtain it in accordance with the
law, ensure the security of the information, and must not illegally collect, use, process, or
transmit other people’s personal information or illegally buy, sell, provide, or disclose the
information. The Personal Information Protection Law of the PRC (ڦ
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) promulgated by the SCNPC on August 20, 2021 and implemented on
November 1, 2021 further emphasizes the obligations and responsibilities of processors
for the protection of personal information, and requests higher level of protective
measures on the processing of sensitive personal information.
According to the Cybersecurity Law of the PRC ( )
promulgated by the SCNPC on November 7, 2016 and effective on June 1, 2017, and
amended on 28 October 2025, with the latest revised version becoming effective on 1
January 2026, network operators must follow the principles of legality, legitimacy and
necessity when collecting and using personal information, publicly disclose the rules for
collection and use, clearly state the purpose, method and scope of collecting and using
information, and obtain the consent of the person whose data is being collected. Network
operators shall not collect personal information unrelated to the services they provide.
Network operators are not allowed to leak, tamper with, or damage the personal
information they collect, and are not allowed to provide personal information to others
without the consent of the person whose data is being collected. However, this does not
apply to cases where a specific individual cannot be identified, and the identity cannot be
recovered after processing. Network operators should take technical measures and other
necessary measures to ensure the security of the personal information they collect and
prevent leakage, damage and loss of information.
Laws and Regulations on Overseas Securities Offering and Listing by Domestic
Companies
Securities Law of the PRC
The Securities Law of the People’s Republic of China () (the
“Securities Law”) took effect on July 1, 1999 and was revised on August 28, 2004, October
27, 2005, June 29, 2013, August 31, 2014 and December 28, 2019, respectively. The latest
revised Securities Law came into effect on March 1, 2020. This is the first national
securities law in the PRC, which is divided into 14 chapters and 226 articles regulating,
among other things, the issuance and trading of securities, takeovers by listed companies,
securities exchanges, securities companies and the duties and responsibilities of the State
Council’s securities regulatory authorities. The Securities Law comprehensively regulates
activities in the PRC securities market. Article 224 of the Securities Law provides that
domestic enterprises shall comply with the relevant provisions of the State Council to list
its shares outside the PRC. Currently, the issuance and trading of foreign issued shares
(including H shares) are mainly governed by the rules and regulations promulgated by the
State Council and the CSRC.
Overseas Listing
On February 17, 2023, the CSRC promulgated the Overseas Listing Trial Measures (ྤʫ
), and relevant supporting guidelines, which came
into effect on March 31, 2023. The Overseas Listing Trial Measures comprehensively
improves and reforms the existing regulatory regime for overseas offering and listing of
PRC domestic companies’ securities and regulates both direct and indirect overseas
offering and listing of PRC domestic companies’ securities. Any domestic company that is
deemed to conduct overseas offering and listing activities shall file with the CSRC in
accordance with the Overseas Listing Trial Measures.
The Overseas Listing Trial Measures provide that the overseas securities offering
and listing will be considered a direct overseas offering by a PRC domestic company if the
issuer is a company limited by shares registered and established in mainland China.
Pursuant to the Overseas Listing Trial Measures, an issuer shall file with the CSRC
within three business days after its application for initial public offering is submitted to
competent overseas securities regulators.
H-share Full Circulation
“Full circulation” means listing and circulating on the stock exchange of the
domestic unlisted shares of an H-share listed company, including unlisted domestic
shares held by domestic shareholders prior to overseas listing, unlisted domestic shares
additionally issued after overseas listing, and unlisted shares held by foreign
shareholders. On November 14, 2019, the CSRC issued the Guidelines for the “Full
Circulation” Program for Domestic Unlisted Shares of H-share Listed Companies ( Hʮ
ˏ) (the “Guidelines for the Full Circulation”),
which was partly revised on August 10, 2023 according to the Decision on Revising and
Abolishing Part of Securities and Futures Policy Documents by CSRC ( ʕ਷ᗇՎ္ຖ၍ଣ
 ).
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According to the Guidelines for the Full Circulation, shareholders of domestic
unlisted shares may determine by themselves through consultation the amount and
proportion of shares, for which an application will be filed for circulation, provided that
the requirements laid down in the relevant laws and regulations and set out in the policies
for state-owned asset administration, foreign investment and industry regulation are met,
and the corresponding H-share listed company may be entrusted to file the said
application for full circulation. To apply for full circulation, an H-share listed company
shall file the application with the CSRC according to the administrative filing procedures
necessary for the Overseas Listing Trial Measures. After the application for full circulation
has been approved by the CSRC, the H-share listed company shall submit a report on the
relevant situation to the CSRC within 15 days after the registration with CSDCC of the
shares related to the application has been completed.
On December 31, 2019, CSDCC and the Shenzhen Stock Exchange (“SZSE”) jointly
announced the Measures for Implementation of H-share Full Circulation Business ( Hٰ
) (the “Measures for Implementation”). The businesses in relation
to the H-share full circulation business, such as cross-border transfer registration,
maintenance of deposit and holding details, transaction entrustment and instruction
transmission, settlement, management of settlement participants, services of nominal
holders, etc. are subject to the Measures for Implementation.
On June 30, 2025, the Shenzhen Branch of CSDC issued the latest Guidelines to the
Program for “Full Circulation” of H-shares of Shenzhen Branch of China Securities
Depository and Clearing Corporation Limited (ப΂ʮ̡ଉέʱʮ
̡H), which are applicable to the business preparation, cross-border
share transfer registration and overseas centralized custody, the initial maintenance of
details of domestic shareholding and the maintenance of its changes, corporate actions,
clearing, settlement and risk management measures. On the same day, China Securities
Depository and Clearing (Hong Kong) Company Limited issued the H-Share Full
Circulation Business Guide of China Securities Depository and Clearing (Hong Kong)
Limited (ʮ̡H), which is applicable
to businesses such as share custody and depository, agent service, arrangement for
settlement and delivery, and risk management measures.
Confidentiality and Archives Administration
On February 24, 2023, the CSRC, the MOF, the National Administration of State
Secrets Protection and the National Archives Administration jointly released the revised
Provisions on Strengthening the Confidentiality and Archives Administration of Overseas
Securities Offering and Listing by Domestic Companies (̋੶ྤʫΆุྤ̮೯БᗇՎ
 )(the”Archives Administration Provisions”), which
came into effect on March 31, 2023. According to the Archives Administration Provisions,
the domestic companies shall establish and implement a solid confidentiality and archives
administration system and take necessary measures to fulfill the confidentiality and
archives administration obligations, and shall not divulge state secrets or work secrets of
state organs, or harm the interests of the state or the public in the overseas securities
offering and listing activities of such domestic companies.
In terms of providing accounting archives or copies thereof to any other entities or
persons (such as securities companies, securities services providers and overseas
regulators), the Archives Administration Provisions stipulate that relevant governmental
procedures should be complied with. Any violation of the above regulations may subject
the domestic companies to regulatory penalties under the Safeguarding State Secrets Law
of the PRC ( ) and the Archives Law of the PRC ( ʕശɛ
) and even criminal liabilities to the extent applicable.
REGULATORY OVERVIEW
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OVERVIEW
We are a biotechnology company specializing in the discovery, development and
commercialization of bi-/multi-specific peptide drugs for the treatment of metabolic
diseases as well as cardiovascular and cerebrovascular diseases, with our Core Product in
Phase III clinical trials. Our history can be traced back to the establishment of our
predecessor, Shaanxi Micot Technology Co., Ltd.* (ʮ̡ ) in January
2007 under the laws of the PRC, and our Group was founded by Dr. Wang Bing, our
Chairman, Chief Executive Officer and executive Director. At inception, our Company
first focused on the R&D of medical devices, and in particular a medical device designed
to separate rare cells from human blood. Due to funding constraints at the time, the Group
discontinue the medical device project. Following that and leveraging Dr. Wang Bing’s
extensive experience in peptide research as well as the Group’s assessment of the broad
market potential, in 2011, we shifted our focus to the development of peptide drugs, and
secured our first significant funding through the National Major Scientific and
Technological Special Project for Major New Drug Development, a government-funded
R&D program, under which we have cumulatively received approximately RMB 3.0
million in funding since 2013 to support our R&D activities. In particular, we directed
efforts towards our previous pipeline product MT1001 (Prifibatide) for treating acute
coronary syndrome, the patent applications and patents related to which were
out-licensed by us to a third party and will be transferred to such third party upon among
other things the drug manufacture approval of MT1001 being issued. Save for the MT1001
project, we have been conducting and will continue to conduct discovery, development
and commercialization of drugs in-house. The Group’s historical operations since its
transition to peptide drug development in 2011 are consistent with and supportive of its
current business and development strategies. Since our transition to peptide drug
development in 2011, we have maintained a consistent and focused strategic direction.
Our accumulated R&D experience of over a decade forms the foundation of our current
business, including our pipeline of globally leading bi-/multi-functional peptide drug
candidates anchored by our Core Product MT1013, and supports our strategies to
accelerate clinical development and commercialization, advance peptide drug candidates
with innovative mechanisms, and deepen strategic collaborations. In January 2025, we
converted from a limited liability company into a joint stock limited company with our
corporate name changed to Shaanxi Micot Pharmaceutical Technology Co., Ltd. (߅
ʮ̡ ). As of the Latest Practicable Date, the registered capital of our
Company was RMB5,473,719, divided into 273,685,950 Shares, with a nominal value of
RMB0.02 each.
MILESTONES
The following sets out a summary of our key development milestones:
Year Milestone(s)
2007 ........ T h ep r edecessor of our Company, Shaanxi Micot Technology Co., Ltd.*
(ʮ̡ ) was established in January
2013 ........ W ec o m pleted the National Major Scientific and Technological Special
Project for major new drug development, focusing on the R&D of key
sustained-release technologies and products for protein and
peptide-based pharmaceuticals* ({ஐͣ
೯ )
2014 ........ W e successfully out-licensed our self-developed pipeline product
MT1001 to Shandong Danhong Pharmaceutical Co., Ltd* (Ⴁᖹ
ʮ̡ ) (previously known as Heze Buchang Pharmaceutical Co.,
Ltd.* (ʮ̡ ))
2016 ........ O u r application for the National Major Scientific and Technological
Special Project for “Major New Drug Development” — clinical research
on Prifibatide for Injection, a category 1.1 new drug for the treatment of
acute coronary syndrome* (ڿ׌ܢ
এၝΥस1.1Ӻ) was accepted
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Year Milestone(s)
2019 ........ W e obtained IND approval from the FDA for the development of
MT1002 for the treatment of ACS+PCI
2021 ........ W e obtained IND approval from the FDA for the development of
MT1013 for the treatment of CKD-SHPT and was accepted by the NMPA
We obtained IND approval from the NMPA for the development of
MT1002 for the treatment of ACS+PCI
We obtained IND approval from the FDA for the development of
MT200605 for the treatment of ischemic stroke
2023 ........ W e obtained IND approval from the NMPA for the development of
MT200605 for the treatment of acute ischemic stroke
We obtained IND approval from the NMPA for the development of
MT1002 for the treatment of Stroke and HD-PF4
We obtained IND approval from the FDA for the development of
MT1002 for the treatment of HD and was accepted by the NMPA
2024 ........ W e obtained IND approval from the FDA for the development of
XTL6001 for the treatment of obesity and weight management
2025 ........ W e obtained IND approval from the NMPA for the development of
XTL6001 for the treatment of Proteinuric CKD
OUR SUBSIDIARIES
As of the Latest Practicable Date, our Group comprised our Company, eight
subsidiaries and two branches. The following table sets out certain information of our
subsidiaries as of the Latest Practicable Date:
Name of Subsidiaries
Date and
place of
incorporation
Authorized share
capital/ Registered
capital
Equity interest
attributable to
our Group Principal business activities
Micot (Suzhou) Pharmaceutical
Co., Ltd.*
(ʮ̡) ....
September 2, 2022,
PRC
RMB10,000,000 100% Medical and engineering technology
R&D, technology services and
transfers, and sales of medical
equipment
Micot (Suzhou) Technology
Co., Ltd.*
(ʮ̡) ....
August 20, 2020,
PRC
RMB80,000,000 100% Medical research and experimental
development; technology services,
development, consultation,
exchange, transfer, and promotion
Xi’an Biocare Pharma Ltd.
(ʮ̡) .....
August 11, 2017,
PRC
RMB60,000,000 100% Biopharmaceutical R&D,
manufacturing, and commercial
distribution
Micot (Taizhou) Pharmaceutical
Technology Co., Ltd.*
(ʮ̡) ..
May 16, 2025, PRC RMB50,000,000 100% Medical R&D, and drug production,
clinical trial services and distribution
Shanghai Xitaili Biomedical Technology
Co., Ltd.*
(ʮ̡) ...
November 22, 2022,
PRC
RMB33,683,333 89.06% Medical and cellular technology R&D,
technical services and sales of
medical equipment
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Name of Subsidiaries
Date and
place of
incorporation
Authorized share
capital/ Registered
capital
Equity interest
attributable to
our Group Principal business activities
Micot (Hong Kong) Technology Limited
(ʮ̡) ....
October 29, 2021,
Hong Kong
HKD10,000 100% Pharmaceuticals and medical devices
R&D, production, promotion and
distribution
Micot (U.S.) Technology Co., Ltd
(ʮ̡) ....
November 29, 2021,
US
USD20,000 100% Overseas R&D and operations
Micot (U.S.) Biopharmaceutics Co., Ltd
(ʮ̡) ....
September 21, 2022,
US
USD1,000 100% Overseas R&D and operations
The following table sets out certain information of our branches as of the Latest
Practicable Date:
Name of branches
Date of
incorporation Location Principal business activities
Shaanxi Micot Pharmaceutical
Technology Co., Ltd. Beijing Branch
(ʮ̡
̏ԯʱʮ̡) ..................
March 1, 2021 Beijing, PRC Providing administrative and
operational support to the
Group
Shaanxi Micot Pharmaceutical
Technology Co., Ltd. Shanghai Branch
(ʮ̡
ɪऎʱʮ̡) ..................
August 28, 2024 Shanghai, PRC Providing administrative and
operational support to the
Group
Former pipeline product – MT1001 (Prifibatide)
In 2011, our Company started focusing on developing peptide drugs and in
particular, we commenced R&D activities on our previous pipeline product Prifibatide
which is indicated for treating acute coronary syndrome.
Having conducted pre-clinical studies on the API and injectable formulation of
Prifibatide (a class 1.1 novel anti-platelet chemical drug), and after taking into account its
relatively limited financial and R&D resources at the time, and having considered the
respective development capabilities, the collaboration model and the expected economic
benefits, the Group decided to adopt an out-licensing model to conduct collaborative
development of the project, we entered into a technical development agreement with
Shandong Danhong Pharmaceutical Co., Ltd.* (ʮ̡) (formerly known
as Heze Buchang Pharmaceutical Co., Ltd.*ʮ̡) (“Shandong
Danhong”) on October 30, 2013 (“Technical Development Agreement”) which is an
Independent Third Party for the cooperation on the development thereof. According to
the Technical Development Agreement, we were responsible for pre-clinical research,
preparing and submitted application for clinical trial approval, and providing technical
guidance for process validation and sample production, and Shandong Danhong was
responsible for phases I, II and III clinical trials, application for new drug certificate and
production approval, providing GMP production facilities, and bearing all associated
costs for these activities.
The development fee to be paid by Shandong Danhong to our Company was
RMB120 million, to be paid in five installments. The settlement date of the five
installments were tied to specific milestones as follows: (i) RMB12 million upon the
signing of the Technical Development Agreement; (ii) RMB58 million upon obtaining
clinical trial approval; (iii) RMB20 million upon completion of phase I clinical trials and
obtaining approval for phase II trials; (iv) RMB20 million upon completion of phase II
trials and approval for phase II trials; and (v) RMB10 million upon obtaining the new drug
certificate and production approval for MT1001. The development fee was determined
between the parties through arm’s length negotiation taking into account, among other
things, our costs in the early research and intellectual property development of MT1001
up to the date of the Technical Development Agreement, costs for completing the
remaining preclinical work and preparing the clinical trial application, our scientific
expertise, technical know-how, resources dedicated to the project and the transfer of the
relevant intellectual properties.
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Pursuant to the Technical Development Agreement, patents in respect of MT1001
shall be transferred to Shandong Danhong upon the full settlement of the RMB120 million
development fee, and any new discoveries during clinical trials shall belong to both
parties, with terms to be negotiated separately.
Following the completion of the preclinical development of MT1001, we entered
into agreements with Shandong Danhong from 2016 to 2018 for phase I clinical study of
Prifibatide whereby Shandong Danhong had engaged our Company for, among other
things, the design, management, oversight and reporting of the phase I study for
Prifibatide and managing trial execution at third-party clinical sites at the aggregate fees
of RMB13.14 million, which determined by the parties through arm’s length negotiation.
All fees under these clinical agreements have been settled.
As of the Latest Practicable Date, Shandong Danhong has paid RMB83.15 million of
the fee under the Technical Development Agreement in accordance with the terms thereof.
The project has been stalled since the completion of phase I, as Shandong Danhong halted
further development thereon, and therefore did not advance to later clinical stages or
trigger subsequent milestone for payment under the Technical Development Agreement.
Following the completion of the phase I clinical trial, our Company did not receive any
notification from Shandong Danhong regarding the advancement to subsequent
development stages, nor did Shandong Danhong provide any explanation as to the
reasons for halting further development. The Technical Development Agreement imposed
no obligation on Shandong Danhong to disclose or explain its internal development
decisions to us, and accordingly our Company is not aware of the specific reasons for the
discontinuation. To the best of our Company’s knowledge, there were no disputes,
disagreements or outstanding issues between us and Shandong Danhong under the
Technical Development Agreement, nor was there any fault on the part of us that led to the
halting of the project. The project was not terminated by us and our Company has fulfilled
its obligations under the Technical Development Agreement.
The development and commercialization rights for MT1001 belonged to Shandong
Danhong under the Technical Development Agreement and Purabatide is not part of our
current pipeline.
ESTABLISHMENT AND MAJOR CORPORATE DEVELOPMENT
Establishment and Shareholding Changes prior to 2011
On January 19, 2007, the predecessor of our Company was established under the
laws of the PRC known as Shaanxi Micot Technology Co., Ltd.* (ʮ
̡) with an initial registered capital of RMB3,000,000 by Dr. Wang Bing ( ˮΏ), Mr. Wang
Yan (ࣝMr. Guo Dapeng (ெɽᘄ), Ms. Ren Yaping (΂ඩ̻), and Mr. Yu Gang (࡝,)
holding 60.00%, 20.00%, 10.00%, 5.00% and 5.00% of our Company’s then registered
capital, respectively.
Equity T ransfers in October 2011
Mr. Guo Dapeng, Mr. Yu Gang and Mr. Wang Yan invested in our Company when we
initially focused on the R&D of medical devices. In 2011, our Company made a strategic
pivot to shift our focus towards the R&D of innovative drugs. Following this
reorientation, Mr. Guo Dapeng, Mr. Yu Gang and Mr. Wang Yan whose investment thesis
was aligned with the original medical device focus had intended to exit our Company in
October 2011 and Dr. Wang Bing had intended to acquire their respective equity interest in
our Company at the time. However, as Dr. Wang Bing would like to devote more time in
his academic research and related areas, he had decided to entrust his equity interest in
our Company, including the equity interest under his own name and those to be acquired
from Mr. Guo Dapeng, Mr. Yu Gang and Mr. Wang Yan, to his family members so as to
reduce his personal administrative burden.
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Against such background, on October 10, 2011, Mr. Guo Dapeng, Dr. Wang Bing and
Mr. Yu Gang each entered into an equity transfer agreement with Ms. Wang Qiuxia (being
the mother of Dr. Wang Bing), and Mr. Wang Yan entered into an equity transfer agreement
with Mr. Wang Anmin (being the father of Dr. Wang Bing).
Pursuant to the aforesaid agreements, Mr. Guo Dapeng, Dr. Wang Bing and Mr. Yu
Gang transferred their respective equity interest of 10%, 60% and 5% in our Company to
Ms. Wang Qiuxia at consideration of RMB300,000, RMB1,800,000 and RMB150,000,
respectively. On the same date, Mr. Wang Yan transferred 20.00% equity interest in our
Company to Mr. Wang Anmin at a total consideration of RMB600,000, reflecting the
amount of registered capital transferred.
Such entrustment arrangement was terminated in March 2020. For details, see “—
Release of Equity Interest Entrusted by Dr. Wang Bing” in this section.
Upon completion of the above transfers in October 2011, our Company was owned
by Ms. Wang Qiuxia, Mr. Wang Anmin and Ms. Ren Yaping as to 75.00%, 20.00% and
5.00%, respectively.
Equity T ransfer in September 2014
On August 18, 2014, Ms. Ren Yaping intended to exit and entered into an equity
transfer agreement with Ms. Wang Qiuxia to transfer all her equity interest, totaling 5.00%
equity interest in our Company to Ms. Wang Qiuxia at a total consideration of
RMB150,000, reflecting the amount of registered capital transferred.
Upon completion of the above transfer in September 2014, our Company was owned
by Ms. Wang Qiuxia and Mr. Wang Anmin as to 80.00% and 20.00%, respectively.
Equity T ransfer in March 2016
Following the passing of the late Mr. Wang Anmin in the first half of 2015, the 20%
equity interest held in the name of the late Mr. Wang Anmin was recognized as part of his
estate, where 10% equity interest had been transferred to Ms. Wang Qiuxia and 10% equity
interest had been transferred to Dr. Wang Bing. Subsequently, as a part of their family
arrangement, Dr. Wang Bing and Ms. Wang Qiuxia had agreed to transfer such 20% equity
interest to Dr. Wang Mei, Dr. Wang Bing’s spouse. As such, an equity transfer agreement
was entered into by Ms. Wang Qiuxia, Dr. Wang Bing and Dr. Wang Mei on March 16, 2016,
pursuant to which, each of Ms. Wang Qiuxia and Dr. Wang Bing agreed to transfer their
respective 10% equity interest in our Company to Dr. Wang Mei. As a result of such
transfers, the entrustment arrangement between the late Mr. Wang Anmin and Dr. Wang
Bing had then been terminated.
Upon completion of the above transfer in March 2016, our Company was owned by
Ms. Wang Qiuxia and Dr. Wang Mei as to 80.00% and 20.00%, respectively.
Equity T ransfer in August 2019
On July 22, 2019, Ms. Wang Qiuxia and Dr. Wang Mei each entered into an equity
transfer agreement with Xi’an Zhongrui, for the purpose of transferring the incentive
equity interest to our employee incentive platform. Pursuant to the aforesaid agreements,
Ms. Wang Qiuxia and Dr. Wang Mei transferred 6% and 4% equity interest to Xi’an
Zhongrui, at the consideration of RMB180,000 and RMB120,000, respectively, reflecting
the amount of registered capital transferred.
Upon completion of the above transfers in July 2022, our Company was owned by
Ms. Wang Qiuxia, Dr. Wang Mei and Xi’an Zhongrui as to 74.00%, 16.00% and 10.00%,
respectively.
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Series A Financing
Our Company underwent series A financing through capital increases (“ Series A
Financing”). Under the capital contribution agreement dated July 30, 2019 entered into
among our Company, the Series A Financing investors set forth below and the then
Shareholders of our Company, the registered capital of our Company was increased to
RMB3,690,000 and the following Series A Financing investors agreed to subscribe for a
total amount of RMB690,000 in the registered capital of our Company at an aggregate
consideration of RMB115,000,000. The respective subscription amount and consideration
paid by the subscribers in Series A Financing are set out as follow:
Subscribers
Registered
capital
subscribed for Consideration Basis of consideration
(RMB) (RMB)
Beta Achieve Limited (ʮ̡ ) (“Beta Achieve”) . . . 300,000 50,000,000
Determined based on arm’s
length negotiations among
the relevant parties taking
into account various R&D
advancements of our
Company, including the
completion of the MT1002
US IND approval and the
initiation of its Phase I
clinical trial.
Tianjin Huaxin Pharmaceutical Venture Capital
Partnership (Limited Partnership)*
(Υྫ)
(“Huaxin Pharmaceutical V enture Capital ” ).......
120,000 20,000,000
Shaanxi Junying Growth Industry Development Fund
Partnership (Limited Partnership)*
(Υྫ)
(“Junying Growth” ) ....................
120,000 20,000,000
Shaanxi New Materials High-Tech Venture Investment
Fund (Limited Partnership)* (৷Ҧஔ௴ุҳ
Υྫ) (“New Materials Fund” ) .......
120,000 20,000,000
Xi’an Jingcheng Daxing Enterprise Management
Partnership (Limited Partnership)
(Υྫ)
(“Jingcheng Daxing” ) ...................
30,000 5,000,000
Release of Equity Interest Entrusted by Dr. Wang Bing
On March 30, 2020, in order to release the equity interest entrusted by Dr. Wang
Bing, Ms. Wang Qiuxia and Dr. Wang Bing entered into an equity transfer agreement,
pursuant to which, Ms. Wang Qiuxia transferred all her equity interest, totaling
approximately 60.17% equity interest in our Company to Dr. Wang Bing at a total
consideration of RMB2,220,000, reflecting the amount of registered capital transferred.
Upon completion of the Series A Financing and the aforementioned equity transfer, Dr.
Wang Bing, Dr. Wang Mei, Beta Achieve, Xi’an Zhongrui, Huaxin Pharmaceutical Venture
Capital, Junying Growth, New Materials Fund and Jingcheng Daxing hold 60.17%,
13.01%, 8.13%, 8.13%, 3.25%, 3.25%, 3.25% and 0.81% of the Company’s equity
respectively.
Equity T ransfer in January 2021
On December 29, 2020, Dr. Wang Mei and Xi’an Tongshang Investment Partnership
(Limited Partnership)* (Υྫ) (“Xi’an T ongshang ”) entered
into an equity transfer agreement. Pursuant to the aforesaid agreement, Dr. Wang Mei
agreed to transfer 3.22% equity interest in our Company to Xi’an Tongshang as Xi’an
Tongshang intended to invest in our Company at a total consideration of RMB4,276,800
and the consideration was determined based on arm’s length negotiations among the
relevant parties. Upon completion of the aforesaid transfer, Dr. Wang Bing, Dr. Wang Mei,
Beta Achieve, Xi’an Zhongrui, Huaxin Pharmaceutical Venture Capital, Junying Growth,
New Materials Fund, Jingcheng Daxing and Xi’an Tongshang hold 60.17%, 9.79%, 8.13%,
8.13%, 3.25%, 3.25%, 3.25%, 0.81% and 3.22% of the Company’s equity respectively.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Series B and B1 Financing
Our Company underwent series B and B1 financing through capital increases and
equity transfer (“Series B Financing”). Under the capital contribution agreements dated
February 21, 2021 and August 30, 2021 (“ Series B Subscription Agreement(s) ”) entered
into among our Company, the Series B Financing investors set forth below and the then
Shareholders of our Company, the registered capital of our Company was increased to
RMB4,674,000 and RMB4,812,095, respectively, and the following Series B Financing
investors agreed to subscribe for a total amount of RMB984,000 and RMB138,095 in the
registered capital of our Company at an aggregate consideration of RMB360,000,000 and
RMB65,000,000, respectively.
On May 11, 2021, Shanghai NRL Investment Holding Co., Ltd* (ٰ
ʮ̡) (“Shanghai NRL”), being one of the initial Series B Financing investors who
agreed to subscribe for a total amount of RMB546,667 in the registered capital of our
Company at an aggregate consideration of RMB200,000,000 under the Series B
Subscription Agreements, entered into an equity transfer agreement with Suzhou Mainiv
Venture Investment Partnership (Limited Partnership)* (ࠢ
Υྫ) (“Suzhou Mainiv”) to transfer all of its rights and obligations under the Series B
Subscription Agreement to Suzhou Mainiv.
Pursuant to the aforementioned agreements, the respective subscription amount
and consideration paid by the subscribers in Series B Financing are set out as follow:
Subscribers
Registered
capital
subscribed for Consideration Basis of consideration
(RMB) (RMB)
Beta Achieve .......................... 54,667 20,000,000
Determined based on arm’s
length negotiations among
the relevant parties taking
into account various R&D
advancements of our
Company, including the
IND approval from the
FDA for the development
of MT1013 and the
subsequent initiation of its
Phase I clinical trial in the
US, the IND approval from
FDA for the development
of MT2004 and the
subsequent initiation of its
Phase I clinical trial in the
US, as well as the approval
of the IND approval from
the NMPA for the
development of MT1002.
Huaxin Pharmaceutical Venture Capital ........... 35,533 13,000,000
Jingcheng Daxing ....................... 71,501 29,500,000
Suzhou Mainiv ........................ 546,667 200,000,000
Suzhou Rongsheng Xianxing Venture Investment
Partnership (Limited Partnership)*
(Υྫ)
(“Suzhou Rongsheng” ) ...................
136,667 50,000,000
Ningbo Meishan Bonded Port Area Fengchuan
Hongbo Investment Management Partnership
(Limited Partnership)*
(೼ಥਜᔮʇ̾௹ҳ༟၍ଣΥྫΆุ
Υྫ) (“Fengchuan Hongbo” ) ............
102,500 37,500,000
Xinyu Shanjin Runji Equity Investment
Partnership (Limited Partnership)*
(Υྫ)
(“Shanjin Runji” ) ......................
78,956 30,000,000
Xi’an Tangxing Technology Venture Capital
Investment Partnership (Limited Partnership)*
(Υྫ)
(“T angxing T echnology” ) .................
95,605 45,000,000
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Series C Financing
Our Company underwent series C financing through capital increases (“ Series C
Financing”). Under the capital contribution agreement dated January 16, 2023 entered
into among our Company, the Series C Financing investors set forth below and the then
Shareholders of our Company, the registered capital of our Company was increased to
RMB4,984,604 and the following Series C Financing investors agreed to subscribe for a
total amount of RMB172,509 in the registered capital of our Company at an aggregate
consideration of RMB95,000,000. The respective subscription amount and consideration
paid by the subscribers in Series C Financing are set out as follow:
Subscribers
Registered
capital
subscribed for Consideration Basis of consideration
(RMB) (RMB)
Xi’an Huiyu Investment Fund Partnership
(Limited Partnership)*
(Υྫ)
(“Xi’an Huiyu” ).......................
18,159 10,000,000 Determined based on arm’s
length negotiations among
the relevant parties taking
into account various R&D
advancements of our
Company, including the
completion of Phase I
clinical trials for MT1013
and MT1002 in China and
US, the IND approval from
the NMPA for the
development of MT2004
and the completion of its
Phase I clinical trials in the
US, as well as the IND
approvals for the
development of MT1009
and MT200605 from the
FDA and the development
of MT1011 from the NMPA.
Shaanxi Huichang Listed Reserve Enterprise Equity
Investment Fund Partnership (Limited Partnership)*
(ΥྫΆุ
Υྫ) (“Listing Reserve Fund” ) ...........
72,635 40,000,000
Hangzhou Quandewang Enterprise Management Co., Ltd.*
(ʮ̡)
(“Hangzhou Quandewang” )................
18,159 10,000,000
Hainan Ruizheng Enterprise Management Partnership
(Limited Partnership)*
(Υྫ)
(“Hainan Ruizheng” ) ....................
18,159 10,000,000
Shengzhou Yinyun Heman Enterprise Management
Partnership (Limited Partnership)*
(Υྫ)
(“Yinyun Heman” ) .....................
18,159 10,000,000
Hainan Wanfeng Investment Partnership (Limited
Partnership)*
(Υྫ) (“Hainan Wanfeng”)
27,238 15,000,000
Equity T ransfer in March 2024
On March 15, 2024, Junying Growth and Shaanxi Junying Jiacheng Pharmaceutical
Industry Development Fund Partnership (Limited Partnership)* (Գϓᔼᖹପุ೯
Υྫ) (“Junying Jiacheng”) entered into an equity transfer
agreement. Pursuant to the aforesaid agreement, Junying Growth agreed to transfer
approximately 0.81% equity interest in our Company to Junying Jiacheng at a total
consideration of RMB20,000,000. The consideration was determined on arm’s length
negotiations among the relevant parties taking into account the timing of the transfer and
relevant shareholder’s strategic plan.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Conversion into a Joint Stock Company
On December 9, 2024, a Shareholders’ resolution was passed for the conversion of
our Company into a joint stock company with its corporate name changed to Shaanxi
Micot Pharmaceutical Technology Co., Ltd. (ʮ̡ ) and the
registration thereof was completed on January 17, 2025. Upon completion of the
conversion, the registered capital of our Company became RMB4,984,604 divided into
4,984,604 Shares with a nominal value of RMB1.00 each.
Series D Financing
Our Company underwent series D financing through capital increases (“ Series D
Financing”). Under the capital contribution agreements entered into among our
Company, the Series D Financing investors set forth below and the then Shareholders of
our Company, the registered capital of our Company was increased to RMB5,473,719 and
the following Series D Financing investors agreed to subscribe for a total amount of
RMB489,115 in the registered capital of our Company at an aggregate consideration of
RMB235,500,000. The respective subscription amount and consideration paid by the
subscribers in Series D Financing are set out as follow:
Date of the capital
contribution
agreement(s) Subscribers
Number of
Shares
subscribed for Consideration
(RMB)
June 27, 2025 ........ Linhai Qize Maite Venture Investment
Partnership (Limited Partnership)*
(ᑗऎ઼̹ዣ௥त௴ุҳ༟ΥྫΆุ
Υྫ) (“Linhai Qize”)
287,653 138,500,000
September 19, 2025 .... Maicheng Century (Xi’an) Enterprise
Management Partnership Enterprise
(Limited Partnership)*
(Гτ Άุ၍ଣΥྫΆุ
Υྫ) (“Maicheng Century”)
31,154 15,000,000
September 19, 2025 .... Jinan Liuji Enterprise Management
Partnership Enterprise (Limited
Partnership)* (ʬ᝘Άุ၍ଣ
Υྫ) (“Jinan Liuji”)
24,923 12,000,000
September 24, 2025 .... Shaanxi Jingang Nongtou Biomedical
Industry Development Equity
Investment Partnership (Limited
Partnership)* (ᔼᖹ
Υྫ)
(“Shaanxi Jingang”)
62,308 30,000,000
September 26, 2025 .... Shaanxi Innovation Relay Equity
Investment Partnership (Limited
Partnership)* (ᛆ
Υྫ)
(“Shaanxi Innovation Relay ”)
83,077 40,000,000
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EMPLOYEE INCENTIVE SCHEME
Xi’an Zhongrui
In recognition of the contributions of our employees and to incentivize them to
further promote our development, we established Xi’an Zhongrui as our employee
incentive platform, with Xi’an Zhongrui Zekang Enterprise Management Consulting Co.,
Ltd* (ʮ̡ ) (“Zhongrui Zekang ”) (a limited partnership
established in the PRC, owned as to approximately 99.00% by Dr. Wang Mei, of which
99.00% is held for her own benefit and the remaining 1.00% is held by Dr. Wang Bing)
being their general partner. Xi’an Zhongrui was established as a limited partnership on
July 18, 2019, and owned approximately 5.48% of our issued Shares as of the Latest
Practicable Date.
As of the Latest Practicable Date
Employee
Incentive Platform
Date of
Establishment
Percentage of
Shareholding in
our Company Limited Partners
Xi’an Zhongrui . . . July 18, 2019 5.48% Dr. Yu Weiping (our Executive Director
and Senior Vice President), holding
the partnership interest through
Nexarcana Limited, Wang Xiangling
(our Chief Medical Officer), Zou Ran
(our Chief Financial Officer), Wang
Ruiling, Fu Guoqin, and together with
the foregoing individuals, a total of 43
current employees of our Group
Wang Xiangling, Zou Ran, Wang Ruiling and Fu Guoqin had become limited
partners of Xi’an Zhongrui as part of our employee incentive scheme. For information on
Wang Xiangling and Zou Ran, see the section headed “Directors and Senior Management”
in this prospectus. Wang Ruiling joined the Group in June 2018 and serves as a clinical
pharmacology associate director of our Company. Fu Guoqin joined the Group in August
2016 and serves as a senior pharmaceuticals director, a director of the analytical
department of our Company and a deputy general manager of Micot (Suzhou)
Pharmaceutical Co., Ltd., our subsidiary. Wang Ruiling and Fu Guoqin were both
supervisors of our Company as at the Latest Practicable Date.
PRC Legal Advisors’ View on the Employee Incentive Schemes
Our PRC Legal Advisors are of the view that our Company’s equity incentive
matters have been approved and adopted by the relevant decision-making body of our
Company. The Employee Incentive Schemes are formulated in accordance with the
applicable PRC Company Law and other relevant regulations in all material respects. The
relevant equity incentive agreements comply with the provisions of the PRC Civil Code in
all material respects.
MATERIAL ACQUISITIONS AND DISPOSALS
During the Track Record Period and up to the Latest Practicable Date, we did not
conduct any material acquisition or disposal.
SHARE SUBDIVISION
Pursuant to the resolutions of the Shareholders dated September 19, 2025 and April
2, 2026, the Shares had been split on a one-for-fifty basis, and the nominal value of the
Shares had been changed from RMB1.0 each to RMB0.02 each (the “ Share Subdivision ”).
As of the Latest Practicable Date, the registered share capital of our Company had been
RMB5,473,719 with 273,685,950 Shares in a nominal value of RMB0.02 each.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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PRE-IPO INVESTMENT
1. Overview
We underwent rounds of Pre-IPO Investments since our establishment, the details of which are set forth below:
Series A Financing Series B Financing Series B1 Financing Series C Financing
Equity T ransfer in
March 2024 Series D Financing
Date of Agreement(s) .............. July 30, 2019 February 21, 2021
May 11, 2021
August 30, 2021 January 16, 2023 December 11, 2023 June 27, 2025
September 19, 2025
September 19, 2025
September 24, 2025
September 26, 2025
Amount of registered capital and/or shares
subscribed and/or transferred ........
RMB690,000 RMB984,000
2 RMB138,095 RMB172,509 RMB40,353 RMB489,115
Amount of consideration paid in connection
with the equity subscription and transfers . .
RMB115,000,000 RMB360,000,000 2 RMB65,000,000 RMB95,000,000 RMB20,000,000 RMB235,500,000
Date of payment of full consideration ..... September 25, 2019 July 15, 2021 2 September 6, 2021 February 6, 2023 December 27, 2023 September 26, 2025
Approximate cost per RMB1.0 of the registered
capital paid before conversion into a
joint-stock company/per Share
1 .......
RMB166.67 RMB365.85 2 RMB470.69 RMB550.70 RMB495.63 RMB481.48
Discount to the Offer Price 3 ........... 80.45% 57.09% 2 44.79% 35.41% 41.87% 43.53%
Post-money valuation (approximate) of
our Company 4 .................
RMB615,000,000 RMB1,710,000,000 5 RMB2,265,000,000 6 RMB2,745,000,000 7 RMB2,470,499,839 8 RMB2,635,500,000 9
Basis of determination of the valuation and
consideration ..................
The valuation and considerations for each round of Pre-IPO Investments were determined based on arm’s length negotiation amongst the
respective Pre-IPO Investors and our Group (as the case may be) after taking into consideration of the status of our business operations and
product development. Other factors were also taken into account in the determination of the consideration including but not limited to (i)
the investment risk assumed by the relevant Pre-IPO Investors under the market conditions at the time of the relevant investments and (ii)
the strategic benefits which would be brought by the Pre-IPO Investors to our Group as described below.
Lock-up period .................. Under the applicable PRC laws, all existing Shareholders (including the Pre-IPO Investors) are subject to a lock-up period of 12 months
following the Listing Date.
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Series A Financing Series B Financing Series B1 Financing Series C Financing
Equity T ransfer in
March 2024 Series D Financing
Use of proceeds ................. W e utilized the proceeds from our Pre-IPO Investors to support, among others, the R&D activities of our Group, including clinical promotion of our
Core Product pipelines, R&D of pre-clinical product pipelines and the payment of our daily operation and management fees. As of the Latest
Practicable Date, the amount of proceeds from our Pre-IPO Investors that had not been utilized was approximately 31.76% of all the proceeds
from our Pre-IPO Investors. The remaining proceeds will mainly be used to support the R&D activities and the business operations of our Group.
Strategic benefits to our Company ....... A t t h e time of the Pre-IPO Investments, the Directors were of the view that (i) our Company would benefit from the additional capital
provided by the Pre-IPO Investors and their market influence, knowledge and experience and (ii) the Pre-IPO Investments demonstrated the
Pre-IPO Investors’ confidence in the operation and development of our Group.
1 The calculation was based on the amount of consideration paid in connection with the equity/share subscription and transfers by the amount of registe red
capital/share subscribed and/or transferred;
2 The investment amount for Series B Financing does not include the transfer of RMB546,667 registered capital in the Company between Shanghai NRL and Suzhou
Mainiv, given that no new capital was injected to the Company pursuant to the equity transfer agreement entered into on May 11, 2021. For further details, please
refer to “Series B and B1 Financing” in the section.
3 The discount to the Offer Price is calculated based on the currency translation of HK$1.00 to RMB0.87 and on the basis of the Offer Price of HK$19.60, the mid-point
of the proposed range of the Offer Price.
4 Post-money valuation is calculated on the basis of (a) cost per Share; and (b) the total number of Shares our Company upon completion of the relevant round of the
Pre-IPO investment.
5 The increase in the valuation of our Company from the Series A Financing to the Series B Financing was primarily due to significant progress of our R&D progress,
including but not limited to the IND approval from the FDA for the development of MT1013 and the subsequent initiation of its Phase I clinical trial in the US, the IND
approval from FDA for the development of MT2004 and the subsequent initiation of its Phase I clinical trial in the US, as well as the approval of the IND approval
from the NMPA for the development of MT1002.
6 The increase in the valuation of our Company from the Series B and B1 Financing to the Series C Financing was primarily due to significant progress of our R&D
progress, including but not limited to the completion of Phase I clinical trials for MT1013 and MT1002 in China and US, the IND approval from the NMPA for the
development of MT2004 and the completion of its Phase I clinical trials in US, as well as the IND approvals for the development of MT1009 and MT200605 from the
FDA and the development of MT1011 from the NMPA.
7 The decrease in the valuation of our Company from the Series C Financing to the Series D Financing was primarily due to the downturn in the overall
biopharmaceutical market financing activity in China. In and around 2022, there was contraction in the availability of capital, investment appetite and transaction
volumes within China’s biopharmaceutical sector which persisted through the Series D Financing round. Key manifestations of this downturn included tightened
regulatory and capital that led to increased risk aversion among investors, steering investors towards later-stage assets with clearer near-term commercialization
pathways.
8 Series C Financing was completed during a period of more buoyant market sentiment and higher sector valuations. As the March 2024 Equity Transfer was a transfer
of existing shares between related parties, namely Junying Growth and Junying Jiacheng. Transactions between related parties may reflect pricing that differs from
market valuations due to the distinct commercial considerations and arrangements inherent in such transfers.
9 The increase in the valuation of our Company from the Series D Financing to the expected market capitalisation upon Listing is primarily attributable to the
significant progress made across our R&D activities and overall business operations since the completion of the Series D Financing. The Series D Financing was
completed at a post-money valuation of RMB2,635,500,000. Such progress includes, but is not limited to, the advancement of our core and key pipeline products
through critical clinical stages in China, the execution of a business development transaction in respect of MT1013 with Everest Medicines for a total potential
consideration of up to RMB1.24 billion, and the submission of our listing application which has been filed with the CSRC.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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2. Special Rights of the Pre-IPO Investors
Certain Pre-IPO Investors have been granted certain special rights in relation to our
Company, including, among others, pre-emptive rights, rights of first refusal, co-sale
rights, information rights, redemption rights, liquidation preference rights, anti-dilution
rights, and appointment rights of observers to the Board.
The Company and the Series A, Series B, Series B1 and Series C investors entered
into a preferential rights termination agreement on April 29, 2024, pursuant to which the
Company’s obligations in respect of the redemption rights, anti-dilution rights and
liquidation preference rights held by these investors were terminated with effect from
April 30, 2024, while the founders’ corresponding obligations remained effective (the
“obliged founders ”). On June 27, 2025, the Company and the relevant investors entered
into the Series D Shareholding Agreements, pursuant to which the aforementioned
preferential rights, including redemption rights, anti-dilution rights and liquidation
preference rights, were re-granted to investors of Series A, Series B, Series B1 and Series C
with effect from June 27, 2025, and the Company’s corresponding obligations were
reinstated as of that date. The preferential rights for the Series D investors became
effective in July 2025 upon the closing of the Series D financing. For further details of the
termination and re- grant of these rights and their accounting treatment, please refer to
Note 25 to “Appendix I — Accountants’ Report” in this prospectus. Accordingly, the
redemption right had three phases: (1) prior to April 30, 2024, it was granted jointly by the
Company and the obliged founders; (2) from April 30, 2024 to June 27, 2025, the
Company’s obligations were terminated and, accordingly, the redemption right was
granted solely by the obliged founders; and (3) from June 27, 2025, pursuant to the Series
D Shareholding Agreements, the Company’s obligations were reinstated and the
redemption right was again granted jointly by both parties.
Pursuant to a shareholders’ agreement entered into between, amongst others, our
Company and the Pre-IPO Investors (the “ Shareholders Agreement ”), and the Articles of
Association of our Company currently in effect, all special rights granted shall be
automatically terminated on the date immediately before the date of our first submission
of listing application to the Stock Exchange, provided that such rights shall be
automatically and immediately reinstated and restored in the event of rejection, return
and/or termination of our Company’s listing application and/or the filing application by
the Stock Exchange and/or the CSRC (as the case may be) or withdrawal of the listing
application by our Company.
In respect of the redemption right granted by the obliged founders, (i) the Company
did not provide any guarantee; (ii) there is no side agreement; and (iii) as advised by our
PRC Legal Advisor, based on the Shareholders Agreement, from April 30, 2024 to June 27,
2025, the redemption obligation was solely a liability of the obliged founders, and the
Company had no corresponding obligation. During such period, no financial liability
regarding the redemption right was recorded. See Note 25 to “Appendix I — Accountants’
Report” in this prospectus.
3. Information about our Pre-IPO Investors
Our Pre-IPO Investors include Sophisticated Investors, such as Northern Light
Venture Capital (̏฽Έ௴ҳ) and NRL Capital (ॲဧл༟͉), who have made meaningful
investment in our Company in accordance with Chapter 2.3 of the Guide for New Listing
Applicants. Northern Light Venture Capital (through Beta Achieve) and NRL Capital
(through Suzhou Mainiv) will hold approximately 5.35% and 8.24%, respectively, of our
Company’s total issued share capital upon the Listing (assuming that the Over-allotment
Option is not exercised). The background information on our Pre-IPO Investors is set out
below. To the best knowledge of the Directors, save as disclosed below, (i) each of the
Pre-IPO Investors and their respective ultimate beneficial owners is an independent third
party, (ii) has no relationship with any connected persons of our Company or other
Pre-IPO Investors, and (iii) the limited partners of our Pre-IPO Investors (if applicable) are
independent from each other.
Northern Light Venture Capital
Beta Achieve made its initial investment in the Company in July 2019. Beta Achieve
is a limited liability company incorporated under the laws of Hong Kong on December 15,
2017, and is an investment arm of Northern Light Venture Capital. NLVF holds a 91.67%
equity interest in Beta Achieve and is ultimately controlled by Mr. Deng Feng ( ቎ቜ), an
independent third party to our Company. NL Partners is the general partner of NLVF and
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its general partner is Northern Light Venture Capital V , Ltd., a company ultimately
controlled by Mr. Deng Feng. The value of assets under management of Northern Light
Venture Capital as of the Latest Practicable Date was approximately RMB30 billion. The
investment portfolio of Northern Light Venture Capital in the medical and healthcare and
related industries include, among others, GenFleet Therapeutics (Shanghai) Inc. (˙ᔼᖹ
ʮ̡) (a company listed on the Hong Kong Stock Exchange, stock
code: 2595), Suzhou Zelgen Biopharmaceuticals Co., Ltd. (ʮ̡ )
(a company listed on the Shanghai Stock Exchange, stock code: 688266), Brain Aurora
Medical Technology Limited (ʮ̡ ) (a company listed on the Hong
Kong Stock Exchange, stock code: 6681); and iRay Group (ʮ̡ )
(a company listed on the Shanghai Stock Exchange, stock code: 688301). Northern Light
Venture Capital is therefore a Sophisticated Investor. Beta Achieve is an investment
institution of Northern Light Venture Capital, a venture capital dedicated to investing in
early-stage, technology-driven innovative companies, primarily focusing on enterprises
in new technology, healthcare and new customer industries.
NRL Capital
Suzhou Mainiv made its initial investment in the Company in May 2021. Suzhou
Mainiv is a limited partnership established in the PRC on March 25, 2021, and its general
partner is Hainan Nivmai Enterprise Management Partnership (Limited Partnership)* ( ऎ
Υྫ) (“ Hainan Nivmai”), which is controlled by its
general partner, Suzhou NRL Capital Management Co., Ltd. (ʮ̡
) (“Suzhou NRL”), and is held as to 71.43%, 14.29% and 14.29% by Ms. Meng Si (an
Independent Third Party), Shanghai NRL and Suzhou NRL, respectively. Each of Suzhou
Mainiv, Suzhou NRL and Shanghai NRL is ultimately controlled by Mr. Lin Xianghong (؍
ߎa former non-executive Director appointed by NRL Capital and resigned in August
2025 to focus on his other business and personal commitments, and is an investment
vehicle managed by NRL Capital. The value of assets under management of NRL Capital
as of the Latest Practicable Date, exceeds RMB8 billion. The investment portfolio of NRL
Capital in the medical and healthcare and related industries include, among others,
Shanghai BioEngine Sci-Tech Co., Ltd. (ʮ̡ ) (A biotechnology
company specializing in cell culture process technologies, with a registered capital of
approximately RMB32.99 million) and Shanghai Xinchuang Huimei Technology Co., Ltd.*
(ʮ̡) (A healthcare company specializing in medical artificial
intelligence with a registered capital of approximately RMB28.33 million), Jiangsu Gairu
Health Technology Co., Ltd. (ʮ̡) (a company specializing in
digital solutions for primary healthcare, with a registered capital of approximately
RMB56.52 million), and Zhejiang Fuli Analytical Instrument Co., Ltd. (ᄃኜϞ
ʮ̡) (a company specializing in the manufacture of analytical instruments for the
pharmaceutical, food, energy and other industries, with a registered capital of
approximately RMB50 million). NRL Capital is therefore a Sophisticated Investor
ultimately controlled by Mr. Lin Xianghong. As of the Latest Practicable Date, Suzhou
Mainiv had six partners, comprising one general partner and five limited partners
(namely Nanjing Weixin Real Estate Development Co., Ltd. holding 25.39%, Shanghai
Newerly Investment Holdings Co., Ltd. holding 24.65%, Suzhou Newerly Xincheng
Equity Investment Partnership (Limited Partnership) holding 24.65%, Lhasa Economic
and Technological Development Zone Baihui Yihe Phase III Equity Investment
Partnership (Limited Partnership) holding 15.23%, and an independent third-party
individual holding 7.62%), and was ultimately owned as to approximately 49.30% by Mr.
Lin Xianghong, and no other ultimate beneficial owners owned more than 30% benefits in
it. Suzhou Mainiv is a venture capital fund primarily engaged in investment in unlisted
enterprises.
Entities controlled by the People’s Government of Shaanxi Province
(i) Junying Growth
Junying Growth is a limited partnership established in the PRC on December 17,
2018 and its general partner is Shaanxi Growth Enterprise Leading Fund Co., Ltd.* (޲
ʮ̡ ) (“Shaanxi Growth Enterprise Guidance Fund ”), who
held approximately 0.98% of the partnership interest. Shaanxi Growth Enterprise
Guidance Fund was owned as to 70.00% of shares by Shaanxi Shaanxi Investment Capital
Management Co., Ltd.* (ʮ̡ ) and 30.00% of shares by Xi’an
Zhongke Chuangxing Growth Enterprise Service Partnership Enterprise (Limited
Partnership)* (Υྫ ), respectively. As of the
Latest Practicable Date, Junying Growth had two limited partners, Shaanxi Province
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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Growth Enterprise Leading Fund Partnership (Limited Partnership)* (Άุˏ
Υྫ), who held approximately 98.04% of its partnership interest,
and Xi’an Jiuying Fenglong Investment Management Partnership (Limited Partnership)*
(Υྫ ) (“Jiuying Fenglong”), who held
approximately 0.98% of its partnership interest. Junying Growth is mainly engaged in
investment management, venture capital, and equity investment. Shaanxi Growth
Enterprise Guidance Fund and Shaanxi Province Growth Enterprise Leading Fund
Partnership (Limited Partnership) were both ultimately controlled by the State-owned
Assets Supervision and Administration Commission of the Shaanxi Provincial People’s
Government (“Shaanxi Provincial SASAC ”).
(ii) Listing Reserve Fund
Listing Reserve Fund is a limited partnership established in the PRC on December
13, 2022 and its general partners are (i) Changan Huitong Private Equity Fund
Management Co., Ltd.* (ʮ̡) (“Changan Huitong”), which
held 0.50% of the partnership interest. Chang’an Huitong was solely owned by Chang’an
Huitong Group Co., Ltd.* (ப΂ʮ̡ ) and ultimately controlled by the
Shaanxi Provincial SASAC; and (ii) Yulin City Coal Conversion Fund Investment
Management Co., Ltd.* (ʮ̡ ), which held 0.50% of the
partnership interest, and whose ultimate beneficial owner is the Shaanxi Provincial
SASAC. As of the Latest Practicable Date, Listing Reserve Fund had three limited
partners, including (i) Changan Huitong Asset Management Co., Ltd.* (τිஷ༟ପ၍ଣ
ʮ̡ ) (“Changan Huitong Asset ”) which held 49.00% of partnership interest in
Listing Reserve Fund and was ultimately owned by Shaanxi Provincial SASAC; (ii) Yulin
Investment Fund Management Co., Ltd.* (ப΂ʮ̡ ), which held
30.00% of partnership interest in Listing Reserve Fund and was ultimately owned by Yulin
Municipal Finance Bureau (҅ ); and (iii) Yulin City Yuyang District
State-owned Assets Operation Co., Ltd.* (ʮ̡ ), which held
approximately 20.00% of partnership interest in Listing Reserve Fund. As of the latest
Practicable Date, as confirmed by Listing Reserve Fund, Listing Reserve Fund is primarily
engaged in equity investment, investment management and asset management activities
as a private fund.
(iii) Junying Jiacheng
Junying Jiacheng is a limited partnership established in the PRC on October 28, 2022
and its general partner is Shaanxi Growth Enterprise Guidance Co., which held 10.00% of
the partnership interest. Shaanxi Growth Enterprise Guidance Co. was ultimately
controlled by the Shaanxi Provincial SASAC and was owned as to 70.00% of shares by
Shaanxi Shaanxi Investment Capital Management Co., Ltd.* (ʮ̡ )
(which is ultimately owned by Shaanxi Provincial SASAC) and 30.00% of shares by Xi’an
Zhongke Chuangxing Growth Enterprise Service Partnership Enterprise (Limited
Partnership)* (Υྫ) (which is controlled by Li
Hao, an Independent Third Party), respectively. As of the Latest Practicable Date, Junying
Jiacheng had eight limited partners, including (i) Shaanxi Junyuan Huike Investment
Fund Partnership (Limited Partnership)* (Υྫ )
which held 33.00% of partnership interest in Junying Jiacheng and was ultimately owned
by Shaanxi Provincial SASAC; (ii) Xi’an Innovation Investment Fund Partnership
(Limited Partnership)* (Υྫ), which held 25.00% of
partnership interest in Junying Jiacheng and was ultimately owned by Xi’an Municipal
Finance Bureau (҅); (iii) Xi’an Small and Medium Enterprises Development
Fund (Limited Partnership)* (Υྫ), which held 20.00% of
partnership interest in Junying Jiacheng and was ultimately owned by Xi’an Municipal
Finance Bureau (҅); (iv) Tianjin Shenlong Supply Chain Co., Ltd.* (ग़ᎲԶ
ʮ̡), which held 5.00% of partnership interest in Junying Jiacheng; (v) Hainan
Linfengyan Investment Partnership (Limited Partnership)* (ࠢ
Υྫ), which held 4.75% of partnership interest in Junying Jiacheng; (vi) Shaanxi
Hongdaxin Construction Engineering Co., Ltd.* (ʮ̡), which
held 1.25% of partnership interest in Junying Jiacheng; (vii) Xi’an Caijin Huifeng Private
Equity Fund Management Co., Ltd.* (ʮ̡), which held
0.50% of partnership interest in Junying Jiacheng; and (viii) Xi’an Jiuying Fenglong
Investment Management Partnership (Limited Partnership)* (ᔮඤҳ༟၍ଣΥྫ
Υྫ), which held 0.50% of partnership interest in Junying Jiacheng. Junying
Jiacheng is primarily engaged in equity investment, investment management and asset
management activities as a private fund.
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(iv) Xi’an Huiyu
Xi’an Huiyu is a limited partnership established in the PRC on September 23, 2021
and its general partner is Changan Huitong, who held 2.50% of the partnership interest.
Changan Huitong was solely owned by Chang’an Huitong Group Co., Ltd.* (τිஷණྠ
ப΂ʮ̡) which was ultimately controlled by the Shaanxi Provincial SASAC. As of
the Latest Practicable Date, Xi’an Huiyu had one limited partner, being Shaanxi Provincial
Scientific and Technological Innovation Master Fund Partnership (Limited Partnership)*
(Υྫ), who held 97.5% of its partnership interest
and was ultimately controlled by the Shaanxi Provincial SASAC. Xi’an Huiyu is mainly
engaged in investment activities with self-owned funds, equity investment, investment
management and asset management.
(v) Shaanxi Innovation Relay
Shaanxi Innovation Relay is a limited partnership established in the PRC on
December 23, 2024 and its general partners consist of (i) Shaanxi New Era Capital
Management Co., Ltd.* (ʮ̡ ), and (ii) Shaanxi Jinzi, each of
whom held approximately 0.20% of the partnership interest. Shaanxi Jinzi largest ultimate
beneficial owner was the Shaanxi Provincial SASAC, and Shaanxi New Era Capital
Management Co., Ltd. was ultimately controlled by the Department of Finance of Shaanxi
Province of the PRC. Shaanxi Innovation Relay had two limited partners, including (i)
Shaanxi Financial Holding Group Co., Ltd.* (ʮ̡ ), which held
approximately 59.76% of the partnership interest and was ultimately owned by the
Shaanxi Provincial Department of Finance; and (ii) Shaanxi Jinzi Rongtong Equity
Investment Partnership Enterprise (Limited Partnership)* (ᛆҳ༟ΥྫΆุ
Υྫ), which held approximately 39.84% of the partnership interest and was
controlled by Shaanxi Jinzi. Shaanxi Innovation Relay is primarily engaged in investment
activities with its own funds.
(vi) Shaanxi Jingang
Shaanxi Jingang is a limited partnership established in the PRC on December 23,
2024 and its general partners consist of (i) Shaanxi Jinzi Fund Management Co., Ltd* ( ৯Г
ʮ̡) (“Shaanxi Jinzi”), and (ii) Xi’an Agricultural Investment
Management Co., Ltd* (ʮ̡ ), each of whom held 0.50% of the
partnership interest. Shaanxi Jinzi largest ultimate beneficial owner was the Shaanxi
Provincial SASAC, and Xi’an Agricultural Investment Management Co., Ltd was
ultimately controlled by the State-owned Assets Supervision and Administration
Commission of the Xi’an Municipal People’s Government (਷Ϟ༟ପ္ຖ၍
ึ). As of the Latest Practicable Date, Shaanxi Jingang had four limited partners,
including (i) Shaanxi Jinyi Biotechnology Development Co., Ltd.* (࢝
ʮ̡), which held 39.50% of the partnership interest and was wholly owned by
Shaanxi Jinzi; (ii) Xi’an Industrial Doubling Fund Partnership Enterprise (Limited
Partnership)* (Υྫ ), which held 30.00% of the
partnership interest and was ultimately owned by Xi’an Municipal Finance Bureau ( Гτ
҅); (iii) Xi’an Port Capital Management Co., Ltd.* (ʮ̡ ), which
held 15.00% of the partnership interest; (iv) Xi’an Industrial Poverty Alleviation
(Agriculture) Investment Fund Partnership Enterprise (Limited Partnership)* ( Гτ̹ପุ
Υྫ), which held 14.50% of the partnership interest.
Shaanxi Jingang is primarily engaged in investment activities with its own funds.
(vii) New Materials Fund
New Materials Fund is a limited partnership established in the PRC on March 21,
2014 and its general partner is Shaanxi Detongfufang Investment Management Co., Ltd.* (
ʮ̡ ) (“Shaanxi Detongfufang ”), which held approximately
1.95% of the partnership interest. Shaanxi Detongfufang was owned as to 40.00% of shares
by Shaanxi Province Industry Investment Co.,Ltd.* (ʮ̡ ) (“Shaanxi
Industry Investment ”) (which is ultimately owned by the Shaanxi Provincial Department
of Finance through Shaanxi Financial Holding Group Co., Ltd.* (ʮ
̡) (“Shaanxi Financial”)) and 60.00% of shares by Shaanxi Detong Investment
Management Co., Ltd.* (ʮ̡ ), respectively and was ultimately
controlled by Mr. Geng Jian ( অ਄), an independent third party. As of the Latest Practicable
Date, New Materials Fund had six limited partners, including (i) Shanghai
Detonggongying Equity Investment Fund Center (Limited Partnership)* (ٰޮ
Υྫ) which held approximately 19.92% of partnership interest in
New Materials Fund; (ii) Shaanxi Industrial Investment, which held approximately
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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19.53% of partnership interest in New Materials Fund; (iii) Shaanxi Financial, which held
approximately 19.53% of partnership interest in New Materials Fund and was ultimately
owned by the Shaanxi Provincial Department of Finance; (iv) Yingfutech Venture Capital
Co., Ltd. (ʮ̡ ), which held approximately 19.53% of partnership
interest in New Materials Fund and was ultimately owned by Liu Tingru ( ᄎҒኊ), an
Independent Third Party; (v) Baoji High-tech Investment Holding Group Co., Ltd* ( ᘒᕒ৷
ʮ̡) (“Baoji High-tech Investment”), which held approximately
11.72% of partnership interest in New Materials Fund; and (vi) Baoji High-tech Innovation
Service Center Co. Ltd.* (ʮ̡ ) (“Baoji High-tech Innovation ”),
which held approximately 7.81% of partnership interest in New Materials Fund. Baoji
High-tech Investment and Baoji High-tech Innovation are owned by Baoji High-tech
Industries Development Zone Administrative Committee ( ᘒᕒ৷อҦஔପุක೯ਜ၍ଣ։
ึ). New Materials Fund is primarily engaged in venture investment business,
investment consulting and venture management services.
Linhai Qize
Linhai Qize is a limited partnership established in the PRC on May 20, 2025 and its
general partner is ZheShang Venture Capital Co., Ltd.* (ʮ̡ )
(“ ZheShang V enture Capital”), who held approximately 0.07% of the partnership
interest. ZheShang Venture Capital was owned as to approximately 38.71% by Zhejiang
Zhongjian Enterprise Management Co., Ltd.* (ʮ̡ ) (ultimately
beneficially owned by Chen Yuemeng, an independent third party). No other shareholders
hold more than 30.00% shares of ZheShang Venture Capital Co., Ltd.. As of the Latest
Practicable Date, Linhai Qize had three limited partners, Linhai Jingyue Financial
Investment Group Co., Ltd.* (ʮ̡ ) (“Linhai Jingyue”), who
held approximately 79.95% of its partnership interest and was ultimately owned by the
Linhai Municipal Finance Bureau, Mr. Wang Yiqiang ( ˮɓ੶) (a former non-executive
Director who resigned in August 2025 to focus on his other business and personal
commitments), who held approximately 19.32% of its partnership interest, and Mr. Yang
Renlong (เɛᎲ), an independent third party who held approximately 0.67% of the
partnership interest. Linhai Qize is mainly engaged in venture capital (limited to
investment in unlisted companies) and equity investment.
Huaxin Pharmaceutical Venture Capital
Huaxin Pharmaceutical Venture Capital is a limited partnership established in the
PRC on May 16, 2018 and its general partner is Shenzhen Chongshi Private Equity
Investment Fund Management Co., Ltd.* (ʮ̡)
(“Shenzhen Chongshi”), who held approximately 1.48% of the partnership interest.
Shenzhen Chongshi was owned as to 51.00% of shares by Yan Kaijing ( ₢௱ྤ) and 49.00%
of shares by Tianjin Tianshili Health Industry Investment Group Co., Ltd.* ( ˂ɻɢɽ਄ੰ
ʮ̡) (“Tianjin Tianshili Health”), respectively. As of the Latest
Practicable Date, Huaxin Pharmaceutical Venture Capital had only one limited partner,
being Tianjin Tasly Venture Capital Co., Ltd.* (ʮ̡ ) (“Tianjin
T asly”), who held approximately 98.52% of its partnership interest. Tianjin Tianshili
Health and Tianjin Tasly were ultimately owned by Mr. Yan Kaijing. Huaxin
Pharmaceutical Venture Capital is mainly engaged in investment in unlisted companies
and non-public offerings of stocks by listed companies and is controlled by Mr. Yan
Kaijing (₢௱ྤ), an independent third party.
Suzhou Rongsheng
Suzhou Rongsheng is a limited partnership established in the PRC on January 25,
2021, and its general partner is Suzhou High-Tech Venture Capital Group Rongsheng
Investment Management Co., Ltd.* (ʮ̡ )
(“Suzhou Rongsheng ”), who held 1% of the partnership interest. Suzhou Rongsheng was
owned as to 35.00% of equity interest by Suzhou High-tech Venture Capital Group Co.,
Ltd.* (ʮ̡) (“Suzhou High-tech V enture”) and 65.00% of
equity interest by Suzhou Rongyu Venture Capital Partnership Enterprise (Limited
Partnership)* (Υྫ) (“Suzhou Rongyu”), respectively.
The remaining two limited partners of Suzhou Rongsheng were Suzhou Xushuguan
Economic Development Zone Xuchuang Asset Management Co., Ltd.* ( ᘽψ⛰ྨᗫ຾කਜ
ʮ̡), who held 50.00% of the partnership interest and was ultimately
owned by Suzhou Hushuguan Economic and Technological Development Zone
Administrative Committee (ึ ); and Suzhou
High-Tech Venture Capital Group Co., Ltd.* (ʮ̡ ), who held
49.00% of the partnership interest and was ultimately owned by Suzhou Huqiu District
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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People’s Government (ִ݁Suzhou Rongsheng, Suzhou Rongyu and
Suzhou High-Tech Venture were both ultimately controlled by Mr. Miao Lv (ܛSuzhou
Rongsheng is a venture capital fund primarily engaged in investment in unlisted
enterprises. As of the Latest Practicable Date, its total capital contribution amount was
RMB500 million.
Xi’an Tongshang
Xi’an Tongshang is a limited partnership established in the PRC on July 27, 2020 and
its general partner is Mr. Ju Hangsheng (͛), a former non-executive Director as
appointed by Xi’an Tongshang and resigned in August 2025 to focus on his other business
and personal commitments, who held approximately 72.73% of the partnership interest.
As of the Latest Practicable Date, Xi’an Tongshang had only one limited partner, being Ms.
Nie Xiaoxi (ᔗወᘙ), an independent third party who held approximately 27.27% of its
partnership interest. Xi’an Tongshang is mainly engaged in investment activities with its
own funds.
Fengchuan Hongbo
Fengchuan Hongbo is a limited partnership established in the PRC on March 7, 2017
and its general partner is Jingning Fengchuan Jiahong Equity Investment Partnership
(Limited Partnership)* (Υྫ ) (“Fengchuan
Jiahong”), who held approximately 3.85% of the partnership interest and was ultimately
controlled by Mr. Xiang Duan (၌), an independent third party. Fengchuan Jiahong was
owned as to 99.00% of partnership interest by Xiang Duan (၌) and 1.00% of partnership
interest by Beijing Fengchuan Private Equity Fund Management Co., Ltd.* ( ̏ԯᔮʇӷ෍
ʮ̡), respectively. As of the Latest Practicable Date, Fengchuan Hongbo had
two limited partners, Tianjin Longyaohengda Enterprise Management Consulting Co.,
Ltd.* (ʮ̡), who held approximately 67.31% of its
partnership interest and was ultimately owned by Zhang Ruimin (ੵ๿ઽ ), an
Independent Third Party, and Zhejiang Wahaha Venture Capital Co., Ltd.* (௴
ʮ̡), who held approximately 28.85% of its partnership interest and was
ultimately owned by Zong Fuli (ᕢ஁), an Independent Third Party. Fengchuan Hongbo
is mainly engaged in equity investment management.
Jingcheng Daxing
Jingcheng Daxing is a limited partnership established in the PRC on July 18, 2019
and its general partner is Mr. Wang Yiqiang ( ˮɓ੶), and independent third party who
held approximately 19.90% of the partnership interest. As of the Latest Practicable Date,
Jingcheng Daxing had eight limited partners who were each an independent third party,
including (i) Xi’an Jiaotong University Siyuan Puhui Investment Partnership (Limited
Partnership)* (Υྫ ) which held approximately
31.40% of the partnership interest in Jingcheng Daxing and was ultimately owned by
Education Foundation of Xi’an Jiaotong University (ึ ); (ii) Ms. Xue
Miao (ߴwho held approximately 30.97% of partnership interest in Jingcheng Daxing;
(iii) Mr. Gai Wenliang (ڥwho held approximately 4.60% of partnership interest in
Jingcheng Daxing; (iv) Mr. Wang Jianqiao ( ˮᄏఐ), who held approximately 4.60% of
partnership interest in Jingcheng Daxing; (v) Ms. Wang Yanying (ڎwho held
approximately 2.43% of partnership interest in Jingcheng Daxing; (vi) Mr. Qiu Juntao ( ʤ
ᏹ), who held approximately 2.41% of partnership interest in Jingcheng Daxing; (vii)
Mr. Gao Ke (ݚwho held approximately 1.85% of partnership interest in Jingcheng
Daxing; and (viii) Mr. Huang Xuefeng (ࢤwho held approximately 1.85% of
partnership interest in Jingcheng Daxing. Each of the above limited partners of Jingcheng
Daxing is an Independent Third Party. Jingcheng Daxing is primarily engaged in
enterprise marketing planning, management consulting and business information
consulting.
Tangxing Kechuang
Tangxing Kechuang is a limited partnership established in the PRC on August 6,
2019 and its general partner is Tangxing Tianxia Investment Management (Xi’an) Co.,
Ltd.* (ப΂ʮ̡) (“T angxing Tianxia”), which held 1.05% of
the partnership interest. Tangxing Tianxia was owned as to 51.00% of shares by Xi’an
Qiushi Commercial Operation Management Co., Ltd.* (ʮ̡ )
(“Xi’an Qiushi”), 34.00% of shares by Xi’an Hechuang Tonghui Enterprise Management
Consulting Partnership Enterprise (Limited Partnership)* ( ГτΥ௴ΝሾΆุ၍ଣፔ༔Υྫ
Υྫ) (which is ultimately owned by Feng Xue, an Independent Third Party),
and 15.00% of shares by Xi’an Heli Tonghui Enterprise Management Consulting
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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--- page 137 ---
Partnership Enterprise (Limited Partnership)* (ࠢ
Υྫ) (which is ultimately owned by Yang Shengrong, an Independent Third Party),
respectively. Tangxing Tianxia was ultimately controlled by Ms. Gong Puling (ޛ)
through Xi’an Qiushi, an independent third party. As of the Latest Practicable Date,
Tangxing Kechuang had six limited partners who were each an independent third party,
including (i) Shaanxi Mingyuan Real Estate Co., Ltd.* (ப΂ʮ̡ ) which
held 28.42% of partnership interest in Tangxing Kechuang; (ii) New Quality Productivity
Promotion Center of the Ministry of Science and Technology* (ආ
ʕː), which held 26.32% of partnership interest in Tangxing Kechuang; (iii) Mr. Yang
Shengrong (เ͛࿲), which held 16.84% of partnership interest in Tangxing Kechuang; (iv)
Shaanxi Provincial Government Investment Guidance Fund Partnership (Limited
Partnership)* (Υྫ ), which held 10.53% of
partnership interest in Tangxing Kechuang; (v) Xi’an Industrial Investment Fund Co.,
Ltd.* (ʮ̡ ), which held 9.47% of partnership interest in Tangxing
Kechuang; and (vi) Xi’an Fudi Nanotechnology Co., Ltd.* (ʮ̡ ),
which held 7.37% of partnership interest in Tangxing Kechuang. Tangxing Kechuang is
primarily engaged in equity investment, investment management, and investment
consulting.
Shanjin Runji
Shanjin Runji is a limited partnership established in the PRC on July 28, 2020 and its
general partner is Shanghai Shanjin Private Equity Fund Management Co., Ltd.* (ږ
ʮ̡) (“Shanghai Shanjin ”), which held approximately 1.02% of the
partnership interest. Shanghai Shanjin was owned as to 36.00% of shares by Liu Jing ( ᄎẙ
), 34.00% of shares by Lv Yuanyuan (ѐ෤෤), and 30.00% of shares by Shanghai Maisi Lai
Enterprise Management Consulting Partnership Enterprise (Limited Partnership)* ( ɪऎ
Υྫ ) (which is ultimately owned by Liu Jing),
respectively. Each of Liu Jing and Lv Yuanyuan was an independent third party. As of the
Latest Practicable Date, Shanjin Runji had thirty limited partners, and Mr. Zhu Chen ( ϡો
), being its largest limited partner, held approximately 8.47% of partnership interest in
Shanjin Runji. None of the ultimate beneficial owners of Shanjin Runji owned more than
10% benefits in it and each of them was an independent third party. As of the latest
Practicable Date, as confirmed by Shanjin Runji, Shanjin Runji is primarily engaged in
equity investment.
Hainan Wanfeng
Hainan Wanfeng is a limited partnership established in the PRC on December 21,
2022 and its general partner is Mr. Jia Shaochi (༠ˇཱུ ), who held 50.00% of the
partnership interest. Mr. Jia has many years of investment experience, focusing primarily
on the intelligent manufacturing and pharmaceutical sectors. Hainan Wanfeng’s
investment in us is primarily driven by its recognition of our long-term growth potential
and value creation capabilities. As of the Latest Practicable Date, Hainan Wanfeng had
only one limited partner, being Ms. Qiu Bo (ت߇who held 50.00% of its partnership
interest. Hainan Wanfeng is primarily engaged in investment activities and provide asset
management services for self-owned fund investments. Mr. Jia Shaochi and Ms. Qiu Bo are
each an independent third party.
Hangzhou Quandewang
Hangzhou Quandewang is a limited company incorporated in the PRC on August 5,
2022 and is mainly engaged in corporate headquarters management, corporate
management consulting, and information consulting services. Hangzhou Quandewang is
owned as to 99% by Mr. Xu Junqing (ё૶) and 1% by Mr. Xu Zhiqiang (қ੶), both
independent third parties, with a registered share capital of RMB10 million. Mr. Xu has
many years of investment experience, focusing primarily on the photovoltaic power
generation, pharmaceutical, and drone sectors. Hangzhou Quandewang’s investment in
us is primarily driven by its optimism towards the prospects of the biopharmaceutical
industry and its recognition of our development potential.
Hainan Ruizheng
Hainan Ruizheng is a limited partnership established in the PRC on June 15, 2020
and its general partner is Ms. Tang Zhijun (౽ё), an independent third party who held
40.00% of the partnership interest. Ms. Tang has many years of investment experience,
focusing primarily on the consumer goods sector.Hainan Ruizheng’s investment in us is
primarily driven by its confidence in our business development and the innovative drug
space. As of the Latest Practicable Date, Hainan Ruizheng had only one limited partner,
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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--- page 138 ---
being Mr. Cao Zheng (૎͍), an independent third party who held 60.00% of its
partnership interest. Hainan Ruizheng is mainly engaged in other business management
services, market research, and business marketing planning.
Yinyun Heman
Yinyun Heman is a limited partnership established in the PRC on December 7, 2022
and its general partner is Ms. Fu Dongjin ( ௩̆ᆩ), an independent third party who held
10.00% of the partnership interest. Ms. Fu’s investments are primarily focused on the
production and sales of apparel. Yinyun Heman’s investment in us is primarily driven by
its optimism towards the broad prospects of innovative drugs, as well as its recognition of
our development and growth potential. As of the Latest Practicable Date, Yinyun Heman
had five limited partners, who were each an independent third party, including (i) Mr.
Yuan Xuejun (ࠏwho held 60.00% of partnership interest in Yinyun Heman; (ii) Ms.
Chen Xian (௓ᄫ), who held 10.00% of partnership interest in Yinyun Heman; (iii) Ms. Ye
Huili (໢ᅆᘆ), who held 10.00% of partnership interest in Yinyun Heman; (iv) Mr. Dong
Songzhen (ᕄ), who held 5.00% of partnership interest in Yinyun Heman; and (v) Ms.
Shi Xiaohong (ߎwhich held 5.00% of partnership interest in Yinyun Heman. Yinyun
Heman is primarily engaged in enterprise management, management consulting and
socio-economic consulting services.
Maicheng Century
Maicheng Century is a limited partnership established in the PRC on September 17,
2025 and its general partner is Mr. Zhao Yajun (ࠏan independent third party who
held approximately 3.33% of the partnership interest. Mr. Zhao has many years of
investment experience, focusing primarily on the biopharmaceutical and high-technology
sectors. Maicheng Century’s investment in us is primarily driven by its confidence in our
development and growth prospects. As of the Latest Practicable Date, Maicheng Century
had four limited partners who were each an independent third party, including (i) Ms. Wu
Haiping (юऎറ), who held approximately 36.67% of the partnership interest; (ii) Ms.
Zhang Aifang (ٹwho held approximately 13. 33% of the partnership interest; (iii)
Mr. Gou Lei (ᆾ), who held approximately 13.33% of the partnership interest; (iv) Mr.
Gao Yan (৷Ԋ), who held approximately 33.33% of the partnership interest. Maicheng
Century is primarily engaged in investment activities with its owned funds.
Jinan Liuji
Jinan Liuji is a limited partnership established in the PRC on September 16, 2025 and
its general partner is Mr. Guo Jiaxin (㒥), an independent third party who held
approximately 16.67% of the partnership interest. Mr. Guo has many years of experience
in equity investment, with a dedicated focus on long-term value investing. Jinan Liuji’s
investment in us is primarily driven by its optimism towards our long-term development
prospects and its recognition of our value creation capabilities. As of the Latest Practicable
Date, Jinan Liuji had five limited partners who were each an independent third party,
including Mr. Zheng Xiaobin ( ቍʃႷ), Mr. Yan Dong (₢̆), Mr. Meng Zhihai (౽ऎ), Ms.
Ren Yali (΂ԭᘆ), and Mr. Wang Jin (ˮ䆷), and each of whom owned approximately
16.67% of the partnership interest. Jinan Liuji is primarily engaged in business
management, marketing planning and some consulting services.
4. PRC Legal Advisor’s confirmation
As advised by our PRC Legal Advisor, our Company is in the course of making all
necessary registration or filings with the relevant local branch of SAMR in respect of the
Pre-IPO Investments set out above, and the Pre-IPO Investments were conducted in
compliance with the applicable PRC laws and regulations in all material respects.
5. Joint Sponsors’ Confirmation
On the basis that (i) the Listing Date, being the first day of trading of the H Shares on
the Stock Exchange, will take place no earlier than 120 clear days after completion of the
Pre-IPO Investments and (ii) the special rights granted to the Pre-IPO Investors pursuant
to the relevant pre-IPO investment agreements have been terminated immediately before
submission of the first listing application and/or will be terminated no later than the
Listing, as the case may be, the Joint Sponsors confirm that the investments by the Pre-IPO
Investors are in compliance with Chapter 4.2 of the Guide published by the Stock
Exchange.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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--- page 139 ---
6. Public Float and Free Float
Following the conversion of 222,016,700 Unlisted Shares into H shares and upon
completion of the Share Subdivision and the Global Offering (assuming the
Over-allotment Option is not exercised):
(a) each of Dr. Wang Bing, Dr. Wang Mei and Xi’an Zhongrui will be our
Controlling Shareholders and a total of 144,060,050 Shares held by them will
not be counted towards either the public float or the free float, representing
43.43% of our share capital in aggregate;
(b) a total of 222,016,700 Unlisted Shares will be converted into H Shares and
excluding such Unlisted Shares held by our core connected persons, a total of
122,356,650 of such Unlisted Shares will be counted as part of the public float,
representing 36.88% of our share capital in aggregate. However, as the H
Shares held by the current Shareholders holding Unlisted Shares will be
subject to a lock-up period, those H Shares will not count towards the free
float at the time of the Listing; and
(c) as Qiyuan Hong Kong, one of the Cornerstone Investors, is a close associate of
each of Junying Growth, Listing Reserve Fund, Junying Jiacheng, Xi’an
Huiyu, Shaanxi Innovation Relay, Shaanxi Jingang and New Materials Fund
(collectively, the “Existing Shareholders”), all of which are ultimately
controlled by the People’s Government of Shaanxi Province. Upon its
subscription of Offer Shares as a Cornerstone Investor: (i) at the indicative
Offer Price of HK$18.20 (being the low end of the indicative Offer Price
range), Qiyuan Hong Kong will subscribe for 18,756,200 Offer Shares, and
Existing Shareholders and Qiyuan Hong Kong will in aggregate hold
42,565,150 Shares, representing approximately 12.83% of the total Shares; and
(ii) at the indicative Offer Price of HK$21.00 (being the high end of the
indicative Offer Price range), Qiyuan Hong Kong will subscribe for 16,255,400
Offer Shares, and such entities will in aggregate hold 40,064,350 Shares,
representing approximately 12.07% of the total Shares, in each case, whose
Shares will not be counted towards the public float.
(d) as all existing Shareholders (including Pre-IPO Investors) are subject to a
lock-up period of twelve months following the Listing Date under applicable
PRC law, Shares held by them will not count towards free float, and a total of
58,054,400 H Shares to be issued pursuant to the Global Offering will be
counted as part of free float at the time of the Listing, representing 17.50% of
our share capital in aggregate.
Rule 19A.13A of the Listing Rules requires that where the expected market value of
the Shares at the time of Listing is over HK$6,000,000,000 but not exceeding
HK$30,000,000,000, the minimum prescribed percentage of the Shares which must be H
Shares held by the public is determined at the higher of: (i) the percentage that would
result in the expected market value of the H Shares held by the public to be
HK$1,500,000,000 at the time of Listing; and (ii) 15%.
Based on the indicative Offer Price of HK$18.20 (being the low-end of the indicative
Offer Price range), HK$19.60 (being the mid-point of the indicative Offer Price range), and
HK$21.00 (being the high-end of the indicative Offer Price range), and assuming the
Over-allotment Option is not exercised, the expected market value of the H Shares of our
Company would be approximately HK$6,037.7 million, HK$6,502.1 million and
HK$6,966.5 million, respectively. As the market value of our H Shares will exceed
HK$6,000,000,000 but will not exceed HK$30,000,000,000, at least 24.84%, 23.07% and
21.53% of our total issue share shall be held by the public based on the low-end, mid-point
and high-end of the indicative Offer Price range.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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--- page 140 ---
It is expected that, immediately following completion of the Global Offering
(assuming that the Over-allotment Option is not exercised), based on the indicative Offer
Price of HK$18.20 (being the low-end of the indicative Offer Price range), a total of
145,115, 150 H Shares, representing 43.74% of our total issued Share upon the completion
of the Global Offering (assuming that the Over-allotment Option is not exercised) will be
held by the public, which will satisfy the public float requirement under Rule 19A.13A of
the Listing Rules. It is expected that, immediately following completion of the Global
Offering (assuming that the Over-allotment Option is not exercised), based on the
indicative Offer Price of HK$21.00 (being the high-end of the indicative Offer Price range),
a total of 147,615,950 H Shares, representing 44.50% of our total issued Share upon the
completion of the Global Offering (assuming that the Over-allotment Option is not
exercised) will be held by the public, which will satisfy the public float requirement under
Rule 19A.13A of the Listing Rules. Therefore, the Company will be able to meet the public
float requirement under Rule 19A.13A of the Listing Rules.
Rule 19A.13C(1) of the Listing Rules provides that, where a new applicant is a PRC
issuer with no other listed shares at the time of listing, the portion of H shares for which
listing is sought that are held by the public and not subject to any disposal restrictions at
the time listing must normally (i) represent at least 10% of the total number of issued
shares in the class to which H shares belong at the time of listing (excluding treasury
shares), with an expected market value at the time of listing of not less than
HK$50,000,000; or (ii) have an expected market value at the time of listing of not less than
HK$600,000,000.
It is expected that, immediately upon completion of the Global Offering (assuming
the Over-Allotment Option is not exercised), based on the indicative Offer Price of
HK$18.20 (being the low-end of the indicative Offer Price range), except for (i) 273,685,950
Shares held by all existing Shareholders that are subject to a lock-up period of twelve
months following the Listing Date under applicable PRC law; and (ii) 24,681,000 Shares
held by Cornerstone Investors that are subject to a lockup period of six months from and
including the Listing Date, all remaining 33,373,400 Shares, representing 10.06% of the
total Shares, will be counted toward the free float. It is expected that, immediately upon
completion of the Global Offering (assuming the Over-Allotment Option is not exercised),
based on the indicative Offer Price of HK$21.00 (being the high-end of the indicative Offer
Price range), except for (i) 273,685,950 Shares held by all existing Shareholders that are
subject to a lock-up period of twelve months following the Listing Date under applicable
PRC law; and (ii) 21,390,200 Shares held by Cornerstone Investors that are subject to a
lockup period of six months from and including the Listing Date, all remaining 36,664,200
Shares, representing 11.05% of the total Shares, will be counted toward the free float.
Therefore, our Company will be able to satisfy the free float requirement under Rule
19A.13C(1)(a) of the Listing Rules.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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--- page 141 ---
CAPITALIZATION OF OUR COMPANY
The table below is a summary of the capitalization of our Company as of Latest
Practicable Date and immediately following the Share Subdivision, conversion of the
Unlisted Shares into H Shares and the Global Offering (assuming the Over-Allotment
Option is not exercised):
As of the Latest
Practicable Date without
taking into account the
Share Subdivision
Immediately Following the Completion of
the Share Subdivision Conversion of the Unlisted Shares
into H Shares and the Global Offering
Whether
the H
Shares
count
towards
public
float or notShareholder Unlisted Shares H Shares Unlisted Shares T otal Shares
Number of
Shares
Percentage
of
Shareholding
in the Shares
Number of
H Shares
Percentage
of
Shareholding
in the
H Shares
Number of
Unlisted
Shares
Percentage
of
Shareholding
in the
Unlisted
Shares
Number of
Shares
Percentage
of
Shareholding
in the Shares
Controlling Shareholders
D r . W a n g B i n g ........ 2,220,000 40.56% 66,600,000 23.78% 44,400,000 85.93% 111,000,000 33.46% No
D r . W a n g M e i ........ 361,201 6.60% 18,060,050 6.45% – – 18,060,050 5.45% No
Xi’an Zhongrui ....... 300,000 5.48% 15,000,000 5.36% – – 15,000,000 4.52% No
Subtotal ........... 2,881,201 52.64% 99,660,050 35.58% 44,400,000 85.93% 144,060,050 43.43% No
The People’s Government of
Shaanxi Province
Junying Growth . . . . . . . 79,647 1.46% 3,982,350 1.42% – – 3,982,350 1.20% No
Listing Reserve Fund ..... 72,635 1.33% 3,631,750 1.30% – – 3,631,750 1.09% No
Junying Jiacheng ...... 40,353 0.74% 2,017,650 0.72% – – 2,017,650 0.61% No
Xi’an Huiyu ......... 18,159 0.33% 907,950 0.32% – – 907,950 0.27% No
Shaanxi Innovation Relay . . . 83,077 1.52% – – 4,153,850 8.04% 4,153,850 1.25% No
Shaanxi Jingang ....... 62,308 1.14% – – 3,115,400 6.03% 3,115,400 0.94% No
New Materials Fund ..... 120,000 2.19% 6,000,000 2.14% – – 6,000,000 1.81% No
Subtotal ........... 476,179 8.70% 16,539,700 5.9% 7,269,250 14.07% 23,808,950 7.18% No
Other Shareholders
Suzhou Mainiv ....... 546,667 9.99% 27,333,350 9.76% – – 27,333,350 8.24% Yes
Beta Achieve ........ 354,667 6.48% 17,733,350 6.33% – – 17,733,350 5.35% Yes
Linhai Qize . . . . . . . . . 287,653 5.26% 14,382,650 5.14% – – 14,382,650 4.34% Yes
Huaxin Pharmaceutical
Venture Capital ...... 155,533 2.84% 7,776,650 2.78% – – 7,776,650 2.34% Yes
Suzhou Rongsheng ..... 136,667 2.50% 6,833,350 2.44% – – 6,833,350 2.06% Yes
Xi’an Tongshang ...... 1 18,799 2.17% 5,939,950 2.12% – – 5,939,950 1.79% Yes
Fengchuan Hongbo ..... 102,500 1.87% 5,125,000 1.83% – – 5,125,000 1.54% Yes
Jingcheng Daxing ...... 101,502 1.85% 5,075,100 1.81% – – 5,075,100 1.53% Yes
Tangxing Technology .... 95,604 1.75% 4,780,200 1.71% – – 4,780,200 1.44% Yes
Shanjin Runji ........ 78,955 1.44% 3,947,750 1.41% – – 3,947,750 1.19% Yes
Hainan Wanfeng ...... 27,238 0.50% 1,361,900 0.49% – – 1,361,900 0.41% Yes
Yinyun Heman . . . . . . . 18,159 0.33% 907,950 0.32% – – 907,950 0.27% Yes
Hangzhou Quandewang . . . 18,159 0.33% 907,950 0.32% – – 907,950 0.27% Yes
Hainan Ruizheng ...... 18,159 0.33% 907,950 0.32% – – 907,950 0.27% Yes
Maicheng Century ..... 31,154 0.57% 1,557,700 0.56% – – 1,557,700 0.47% Yes
Jinan Liuji ......... 24,923 0.46% 1,246,150 0.44% – – 1,246,150 0.38% Yes
Subtotal ........... 2 , 1 16,339 38.67% 105,816,950 37.78% – – 105,816,950 31.9% Yes
H Shareholders under the
Global Offering
(1) ..... – – 58,054,400 20.73% – – 58,054,400 17.50%
T otal ........... 5,473,719 100.00% 280,071,100 100.00% 51,669,250 100.00% 331,740,350 100.00%
Note:
(1) The Shares to be subscribed by Qiyuan Hong Kong as a Cornerstone Investor will not be counted
towards the public float.
Except for the 99,660,050 H Shares to be held by our Controlling Shareholders upon
Listing and the 51,669,250 Unlisted Shares that will not be converted into H Shares before
the Listing as illustrated above, the rest of the Shares in our Company, namely 180,411,050
H Shares, will be counted towards public float upon Listings.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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--- page 142 ---
CORPORATE STRUCTURE IMMEDIATELY BEFORE COMPLETION OF THE GLOBAL OFFERING
The following chart sets forth our Group’s corporate structure immediately prior to the completion of the Global Offering:
Dr. Wang
Bing
40.56%
6.60%
5.48%
9.99%
6.48%
Dr. Wang
Mei
Xi’an
Zhongrui
Suzhou
Mainiv
Beta
Achieve
5.26%
Linhai
Qize
2.50%
Suzhou
Rongsheng
2.17%
Xi’an
Tongshang
1.87%
Fengchuan
Hongbo
2.19%
New Materials
Fund
2.84%
Huaxin
Pharmaceutical
Venture Capital
1.85%
Jingcheng
Daxing
Xi’an Biocare Pharma Ltd.
100%
Our Company
Micot (Taizhou)
Pharmaceutical
Technology Co., Ltd.
100%
Micot (Hong Kong)
Technology Limited
100%
Shanghai Xitaili
Biomedical Technology
Co., Ltd.
Other
shareholders(1)
Micot (U.S.) Technology
Co., Ltd
89.06%
10.94%
100%
Micot (Suzhou)
Technology Co., Ltd.
100%
Micot (Suzhou)
Pharmaceutical Co., Ltd.
100%
Micot (U.S.)
Biopharmaceutices
Co., Ltd
100%
1.75%
Tangxing
Technology
1.46%
Junying
Growth
1.44%
Shanjin
Runji
0.74%
Junying
Jiacheng
0.50%
Hainan
Wanfeng
0.33%
Hainan
Ruizheng
0.33%
Yinyun
Heman
0.33%
Xi’an Huiyu
0.33%
Hangzhou
Quandewang
1.33%
Listing
Reserve Fund
1.52%
Shaanxi
Innovation Relay
1.14%
0.57%
0.46%
Shaanxi
Jingang
Maicheng
Century
Jinan
Liuji
(1) As of the Latest Practicable Date, Shanghai Xitaili Biomedical Technology Co., Ltd* was owned as to approximately 89.06% by our Company, approximately 4.95% by
Shanghai Huitai Biopharmaceutical Partnership (Limited Partnership)* (Υྫ), approximately 2.47% by Ms. Wang Xin (ؚ,)
approximately 2.47% by Xi’an Xijiao 1896 Kechuang Investment Partnership (Limited Partnership)* (Υྫ) (“Xijiao 1896
Kechuang Investment”) and approximately 1.04% by Xijiao 1896 (Xi’an) Innovation Service Co., Ltd.* (ʮ̡) (“Xijiao 1896
Innovation”). Ms. Wang Xin, an independent third party to our Company, is engaged in the investment in companies in the biomedicine industry. Xijiao 1896
Kechuang Investment and Xijiao 1896 Innovation are ultimately controlled by Mr. Wei Changqing (ڡڗan independent third party to our Company, who holds
investment vehicles to invest in companies in the new materials, new energy, biomedicine and high-end equipment manufacturing industries. Our Company became
acquainted with Ms. Wang Xin and representatives of Xijiao 1896 Kechuang Investment and Xijiao 1896 Innovation through the alumni network of Xi’an Jiaotong
University of which Dr. Wang Bing was an alumnus.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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--- page 143 ---
CORPORATE STRUCTURE IMMEDIATELY FOLLOWING COMPLETION OF THE GLOBAL OFFERING
The following chart sets forth our corporate and shareholding structure immediately following completion of the Global Offering,
assuming the Over-allotment Option is not exercised.
Dr. Wang
Bing
33.46%
5.44%
4.52%
8.24%
5.35%
Dr. Wang
Mei
Xi’an
Zhongrui
Suzhou
Mainiv
Beta
Achieve
4.34%
Linhai
Qize
2.06%
Suzhou
Rongsheng
1.79%
Xi’an
Tongshang
1.54%
Fengchuan
Hongbo
1.81%
New Materials
Fund
2.34%
Huaxin
Pharmaceutical
Venture Capital
1.53%
Jingcheng
Daxing
Xi’an Biocare Pharma Ltd.
100%
Our Company
Micot (Taizhou)
Pharmaceutical
Technology Co., Ltd.
100%
Shanghai Xitaili
Biomedical Technology
Co., Ltd.
100%
Micot (Hong Kong)
Technology Limited
Micot (U.S.) Technology
Co., Ltd
89.06%
100%
Micot (Suzhou)
Technology Co., Ltd.
100%
Micot (Suzhou)
Pharmaceutical Co., Ltd.
100%
Micot (U.S.)
Biopharmaceutices
Co., Ltd
100%
1.44%
Tangxing
Technology
1.20%
Junying
Growth
1.19%
Shanjin
Runji
0.61%
Junying
Jiacheng
0.41%
Hainan
Wanfeng
0.27%
Hainan
Ruizheng
0.27%
Yinyun
Heman
0.27%
Xi’an Huiyu
0.27%
Hangzhou
Quandewang
1.09%
Listing
Reserve Fund
1.25%
Shaanxi
Innovation Relay
0.94%
0.47% 17.50%
0.38%
Shaanxi
Jingang
Maicheng
Century
Public
Shareholders
Jinan
Liuji
Other
shareholders(1)
10.94%
(1) As of the Latest Practicable Date, Shanghai Xitaili Biomedical Technology Co., Ltd* was owned as to approximately 89.06% by our Company, approximately 4.95% by
Shanghai Huitai Biopharmaceutical Partnership (Limited Partnership)* (Υྫ), approximately 2.47% by Ms. Wang Xin (ؚ,)
approximately 2.47% by Xi’an Xijiao 1896 Kechuang Investment Partnership (Limited Partnership)* (Υྫ) (“Xijiao 1896
Kechuang Investment”) and approximately 1.04% by Xijiao 1896 (Xi’an) Innovation Service Co., Ltd.* (ʮ̡) (“Xijiao 1896
Innovation”). Ms. Wang Xin is engaged in the investment in companies in the biomedicine industry. Xijiao 1896 Kechuang Investment and Xijiao 1896 Innovation are
ultimately controlled by Mr. Wei Changqing (ڡڗwho holds investment vehicles to invest in companies in the new materials, new energy, biomedicine and
high-end equipment manufacturing industries. Our Company became acquainted with Ms. Wang Xin and representatives of Xijiao 1896 Kechuang Investment and
Xijiao 1896 Innovation through the alumni network of Xi’an Jiaotong University of which Dr. Wang Bing was an alumnus.
HISTORY, DEVELOPMENT AND CORPORATE STRUCTURE
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OVERVIEW
Who We Are
We are a biotechnology company specializing in the discovery, development and
commercialization of bi-/multi-specific peptide drugs for the treatment of metabolic
diseases as well as cardiovascular and cerebrovascular diseases, with our Core Product in
Phase III clinical trials.
We are committed to advancing peptide drugs as cornerstone therapies across
multiple disease areas. Leveraging over a decade of experience in peptide drug R&D, we
have established a fully integrated platform supporting the industrialization of
bi-/multi-functional peptide drug candidates. As of the Latest Practicable Date, we had
developed a pipeline of bi-/multi-functional peptides and innovative drug candidates,
including: (i) our Core Product, MT1013, the peptide drug targeting both CaSR and OGP
receptors, primarily developed for the treatment of CKD-SHPT, with the potential to be
further developed for additional indications such as CKD-MBD with Osteoporosis and
CKD-SHPT not on Dialysis; and (ii) three Key Products, namely XTL6001, MT1002 and
MT200605, as well as other product candidates.
All of the drug candidates have been in-house developed by us. The chart below
summarizes the development status of our clinical-stage product candidates as of the
Latest Practicable Date:
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Core product Key product
MT200605
Drug Candidates Target/Mechanism Indication RegionTreatment
regimen
IND and IND
Preparation Phase I Phase II Phase III Current Status/Projected Milestones Commercialization
Rights
Metabolic drugs
CaSR/OGP
CKD-SHPT
PRC Complete Phase III clinical trial
by the end of 2026 Global(2)
U.S.
CKD-MBD with Osteoporosis PRC Commence Phase III clinical trial
in early 2028
(1)
Global
CKD-SHPT not on Dialysis PRC File IND by the end of 2027
GLP-1R/
GCGR/MasR
Weight management for
obesity or overweight
PRC Complete Phase I clinical trial
in Q2 of 2026
U.S.
Proteinuric CKD PRC Complete Phase I clinical trial
in Q2 of 2026
MASH PRC File IND in early 2027
MT2004 FXR
(small-molecule)
DILI PRC Complete Phase II clinical trial
by the end of 2027
MASLD
PRC
U.S.
CLD PRC Commence Phase II clinical trial
by the end of 2027
(3)
PTH1R/OGP
GIOP
PRC Commence Phase I clinical trial
in January 2026
U.S.
PMO
PRC Commence Phase I clinical trial
in January 2026
U.S.
Cardio-cerebrovascular drugs
Coagulation
Factor II/
GP IIb/IIIa
ACS-PCI PRC Complete Phase IIb
(4) clinical trial
by mid-2028
Global
U.S.
Stroke PRC Commence Phase II clinical trial(5)(6)
by June 2026
HD
PRC Commence Phase II clinical trial(5)(7)
by July 2026
U.S.
HD-PF4 PRC Commence Phase II clinical trial
by the end of 2027
(5)
TrKB
(small-molecule) AIS
PRC Complete Phase II clinical trial in 2026
U.S.
MT1011 NOACs
(small-molecule)
Universal Anticoagulant
Reversal Agent PRC
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy Complete Phase I clinical trial
in Q2 of 2026
MT1013
XTL6001
MT1009
MT1002
Directly proceed to the next stage Currently evaluating the competitive landscape and formulating the future Clinical Development Plan
Abbreviation: CaSR: Calcium-Sensing Receptor; OGP: Osteogenic Growth Peptide; CKD-MBD: Chronic Kidney Disease-Mineral and Bone Disorder; GLP-1R: Glucagon-like Peptide-1 Receptor; GCGR: Glucagon Receptor; MasR: Mas Receptor;
MASH: Metabolic Dysfunction-associated Steatohepatitis; FXR: Farnesoid X Receptor; DILI: Drug-Induced Liver Injury; MASLD: Metabolic Dysfunction-associated Steatotic Liver Disease; CLD: Cholestatic Liver Disease; PTH1R: Parathyroid hormone 1 receptor; GIOP: Glucocorticoid-Induced Osteoporosis;
PMO: Postmenopausal Osteoporosis; GP IIb/IIIa: Glycoprotein IIb/IIIa Complex; ACS: Acute Coronary Syndrome; PCI: Percutaneous Coronary Intervention; HD: hemodialysis; HD-PF4: HD with heparin-platelet factor 4 complex positive; PF-4: Platelet Factor-4; AIS: acute ischemic stroke; TrkB:
Tyrosine kinase receptor B; NOACs: Novel Oral Anticoagulants
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Notes:
(1) We have completed Phase II clinical trial of the relevant product for the indication of CKD-SHPT, and as patients with CKD-SHPT are all within the CKD-MBD
population, we plan to leverage data collected from respective trials to seek IND approvals from competent regulatory authorities to conduct Phase III clinical trial
of the relevant product for the expanded indication of CKD-MBD with Osteoporosis.
(2) Researched and developed in-house. We have granted Everest Medicines (China) Co., Ltd. (“ Everest”) the exclusive right to sell, commercialize and promote MT1013
for the treatment of CKD-SHPT in Mainland China, Hong Kong, Macao and the Taiwan region as well as the Asia-Pacific region (excluding Japan) (the “ T erritory”).
We reserved the rights to: (i) research, develop and manufacture MT1013 globally; (ii) commercialize MT1013 for any indications outside Territory; and (iii)
commercialize MT1013 in the Territory for any indications other than CKD-SHPT. For more information, see “Business — Commercialization”.
(3) The Phase I clinical trial of MT2004 had conducted adequate safety and dose-ranging evaluation to support the therapeutic dose range for the treatment of MASLD
and CLD in the PRC, thereby providing the basis for directly commencing the respective Phase II clinical trials.
(4) The Phase IIb clinical trial forms part of MT1002-II-C04 and was conducted to further evaluate the selected dose(s) in a larger patient population. For more
information, see “Business — Our Key Product MT1002 — Clinical Trial Overview of MT1002 — MT1002-II-C04 PRC Phase II Efficacy Study in ACS-PCI Patients ”.
(5) The Phase I clinical trial of MT1002 had conducted adequate safety and dose-ranging evaluation to support the therapeutic dose range for the treatment of stroke, HD
and HD-PF4 in the PRC, thereby providing the basis for directly commencing the respective Phase II clinical trials.
(6) In June 2023, we obtained IND approval from the NMPA to conduct a Phase II clinical trial of MT1002 for stroke. Trial preparation was initiated in March 2026,
including the finalization of the clinical trial protocol.
(7) In July 2023, we obtained IND approval from the NMPA to conduct a Phase II clinical trial of MT1002 for HD. Trial preparation was initiated in March 2026, including
the finalization of the clinical trial protocol.
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MT1013
Our Core Product, MT1013, is the dual-targeting receptor agonist polypeptide that
simultaneously targets the CaSR and the OGP receptor. It is designed for the treatment of
CKD-SHPT, CKD-MBD with Osteoporosis and CKD-SHPT not on Dialysis. MT1013’s
clinical studies have demonstrated its significant improvement in comprehensive control
rate of iPTH/serum calcium/serum phosphorus levels, fast-acting and sustained efficacy
in lowering iPTH, cardiovascular benefit potential, enhanced bone mineral density and
metabolism, and a favorable safety and tolerability profile.
• Market and Clinical Needs: The market size of CKD-SHPT drugs in the PRC is
estimated to reach RMB5.0 billion by 2030 and RMB13.1 billion by 2035. Currently,
the clinical management of CKD-SHPT primarily relies on single-target drugs,
which may present limitations such as suboptimal efficacy in severe cases with
significantly elevated iPTH levels, inadequate improvement in bone metabolism
abnormalities, and safety concerns such as the risk of hypocalcemia and
gastrointestinal adverse reactions.
• Promising Clinical Data: MT1013 (i) demonstrated a roughly 2.5-fold higher
comprehensive control rate of iPTH, serum calcium, and serum phosphorus
compared to etelcalcetide in a head-to-head Phase II evaluation; (ii) showed onset of
efficacy within three weeks and sustained control of iPTH levels by week nine, as
observed in a Phase II trial; (iii) exhibited cardiovascular benefit potential as it was
associated with greater FGF23 reduction, a biomarker directly linked to
cardiovascular risk in CKD-SHPT, alongside effective control of iPTH, serum
calcium, and serum phosphorus; (iv) showed a generally favorable safety and
tolerability profile, with no severe hypocalcemia reported across clinical trials; and
(v) enhanced bone mineral density and metabolism, as a Phase II study suggested
that MT1013 was associated with improved bone turnover, metabolism, and
remodeling balance in CKD-SHPT patients.
• Clinical Progress: MT1013 completed its Phase II clinical trials (MT1013-II-C01 and
MT1013-II-C03) for the treatment of CKD-SHPT and has entered a Phase III clinical
trial using Cinacalcet as the active comparator, which is expected to be completed by
the end of 2026. The Pre-NDA submission is planned in late 2026, followed by the
NDA submission in early 2027.
XTL6001
Our Key Product, XTL6001, is a GLP-1R/GCGR/MasR tri-target agonist. The
introduction of MasR into the target panel of GLP-1R/GCGR is novel among current
GLP-1 drugs, with potential applications in the treatment of diseases such as Chronic
Weight Management in Obese or Overweight Populations, Proteinuric CKD, and MASH.
XTL6001’s preclinical studies have demonstrated its ability to preserve muscle mass,
achieve weight loss through enhanced energy metabolism-driven mechanisms and deliver
multi-organ protection.
• Market and Clinical Needs: The global population affected by metabolic diseases
continues to rise, with obesity becoming an increasingly severe issue. The
overweight and obesity drug market in the PRC is expected to reach RMB23.5 billion
in 2030 and RMB107.3 billion in 2035, with a CAGR of 35.5% from 2030 to 2035.
Current GLP-1-based therapies face clinical limitations including muscle loss and
gastrointestinal adverse reactions, highlighting the urgent need for safer and more
effective treatment options.
• Preclinical and Clinical Data: The introduction of MasR, into the GLP-1R/GCGR
panel provides additional benefits. In terms of muscle preservation, XTL6001
activates renal MasR receptors to promote protein synthesis and has demonstrated a
breakthrough effect of “fat loss without muscle loss” in DIO mouse models. In terms
of tolerability, the tri-agonist synergy enables weight loss without significant
appetite suppression, suggesting a lower risk of gastrointestinal adverse events
compared to GLP-1-based drugs that primarily act by delaying gastric emptying.
Phase I clinical trial results further suggest that XTL6001 reduces body weight and
waist circumference, improves lipid profiles, and lowers serum uric acid levels.
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• Clinical Progress: XTL6001 had obtained IND approvals in both the PRC and the
United States for the treatment of Chronic Weight Management in Obese or
Overweight Populations. As of the Latest Practicable Date, the Phase I clinical trial
of XTL6001 in the PRC had completed the LPLV and the database lock. We are also
exploring its potential in other metabolic diseases. A Phase II clinical trial for the
treatment of Proteinuric CKD is expected to commence in mid 2027, and an IND
application for the treatment of MASH is expected to be submitted in early 2027.
MT1002
Our key product, MT1002, is a coagulation factor II and GP IIb/IIIa dual-targeting
peptide antagonist, primarily designed for clinical needs in anticoagulation and
anti-thrombosis for indications such as ACS-PCI, Stroke, HD and HD-PF4. MT1002’s
clinical studies have demonstrated its potential to address the bleeding and ischemia
balance in ACS-PCI, with a fast onset of action, recovery after discontinuation, stable
pharmacokinetic profile, and favorable population adaptability.
• Market and Clinical Needs: The global population of ACS patients continues to
grow, accompanied by a steady increase in the volume of PCI procedures. The
antithrombotic drugs market in the PRC is estimated to reach RMB47.2 billion in
2030 and RMB61.8 billion in 2035. The current standard of care involves a
combination of anticoagulants and antiplatelet agents, which may lead to
challenges such as complex drug-drug interactions and an increasing risk of
bleeding. MT1002, administered via intravenous bolus followed by continuous
infusion is intended for use in emergency PCI settings especially when oral
antiplatelet agents are not yet effective or cannot be administered.
• Clinical Data: Results from the Phase II clinical trials of MT1002 showed that all
subjects successfully completed PCI procedures under the anticoagulant and
antiplatelet effect of MT1002 without thrombotic events or major bleeding. No
deaths, SAEs or early withdrawals due to TEAEs were observed, and all adverse
events were mild or moderate in severity, supporting the favorable safety and
efficacy profile of MT1002.
• Clinical Progress: As of the Latest Practicable Date, MT1002 had completed Phase I
clinical trials in both the PRC and the United States for the treatment of ACS-PCI. A
Phase II clinical trial is underway in the PRC. Upon completion, we plan to initiate
an EOP II meeting with the CDE and proceed to a confirmatory Phase III clinical
trial. We have also obtained Phase II clinical trial approvals in the PRC for
additional indications, including Stroke, HD and HD-PF4, and plan to commence
the Phase II clinical trials of Stroke and HD in the PRC by June 2026 and July 2026,
respectively, and to initiate the Phase II clinical trial of HD-PF4 in the PRC by the
end of 2027.
MT200605
Our Key Product, MT200605, is a neuroprotectant for injection. Its core
breakthrough lies in a dual synergistic mechanism of action — by simultaneously
activating the TrkB receptor and eliminating oxygen radicals, it blocks the post-AIS
pathological cascade via dual pathways. MT200605’s clinical studies have demonstrated
its favorable safety and tolerability profile, as well as dual-pathway synergistic
neuroprotective effects, offering a therapeutic option for patients.
• Market and Clinical Needs: In the PRC, the market size of neuroprotective drugs is
estimated to reach RMB15.7 billion in 2030 and RMB24.6 billion in 2035. Existing
neuroprotective agents may face limitations such as single mechanisms of action,
modest efficacy and low blood-brain barrier penetration rates which may hinder
their ability to comprehensively address the complex cascade of neural damage
following an ischemic event.
• Clinical Data: MT200605 promotes neuronal repair by activating the p-TrkB
signaling pathway and exerts antioxidant radical effects by enhancing SOD and
GSH-Px activities, thereby reducing neuronal cell death. Clinical studies have
shown that MT200605 was safe and well tolerated in healthy subjects, with all
TEAEs related to MT200605 being Grade 1 in severity. No SAEs or withdrawals due
to adverse events were reported, and all TEAEs were reversible or resolved.
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• Clinical Progress: MT200605 has completed Phase I clinical studies in both the PRC
and the United States. A Phase II clinical trial is currently underway in the PRC to
evaluate its neuroprotective effect in patients with AIS, which is expected to be
completed in 2026.
Other Clinical-Stage Pipeline Candidates
We have established a diversified pipeline focused on metabolic diseases
(particularly renal-related) and cardiovascular and cerebrovascular diseases. As of the
Latest Practicable Date, in addition to our Core Product and Key Products, we have been
developing three other clinical-stage drug candidates, including MT2004 for DILI,
MASLD and CLD; MT1009 for GIOP and PMO; and MT1011 for anticoagulant reversal
therapy. Leveraging differentiated mechanisms, these candidates are designed to provide
therapeutic options for diseases with limited effective treatments. See “— Our Drug
Candidates” for more information.
R&D System and T echnology Platforms
We have established four core technology platforms covering the full R&D cycle of
multi-functional peptide drugs, including (i) Bi-/Multi-specific Peptide and
Peptide-based Macromolecule Technology Platform, which adopts a multi-target
synergistic design to precisely identify targets and optimize drug structures,extending
half-life, enhancing metabolic stability, improving specificity and reducing adverse effects
through fusion protein engineering and related techniques; (ii) Computer-aided Peptide
Design Platform, which leverages AI algorithms to accelerate molecular design and
optimization, thereby enabling an intelligent R&D workflow from molecular generation
to druggability evaluation; (iii) Oral Peptide Delivery Platform, which is being developed
to overcome the limitations of injectable peptide therapies with the aim of enhancing
patient convenience and improving treatment adherence; and (iv) Druggability
Evaluation Platform, which supports the selection of clinical candidates from target
validation by leveraging approximately 100 animal models and completing numerous in
vivo and in vitro evaluations annually.
Clinical Development and CMC Capability
We have adopted a self-operated model for clinical development in the PRC, under
which our in-house professional team is responsible for protocol design, management and
execution oversight, with the aim of improving the quality, cost-effectiveness and
efficiency of clinical development. This model ensures closer alignment between trial
design and R&D objectives while enhancing data quality and regulatory compliance. We
have established an integrated CMC platform covering API, formulation and
sustained-release development, with in-house capabilities to conduct process
development. Our CMC R&D center is equipped to support core process development and
optimization from the preclinical to clinical stages without reliance on third-party
partners in process development.
Management T eam
Led by our founder, Chairman and Chief Executive Officer Dr. Wang Bing, we have
achieved significant milestones. Dr. Wang has over 20 years of experience in the
biopharmaceutical industry, underpinned by a solid academic foundation and scientific
expertise. He has served in key industry roles, including as a review expert for the
National Major New Drug Innovation Program (“ɽอᖹ௴Փਖ਼ධ”), and has a proven
track record of professional recognition. Our senior management team possesses expertise
spanning the full drug development lifecycle, from preclinical research to clinical
execution. The team members bring extensive experience at global pharmaceutical
companies and research institutions, and possess capabilities in drug development,
regulatory submission and commercialization.
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OUR STRENGTHS
1. Scientific Insights Facilitating Our Development of Next-Generation
Bi-/Multi-Specific Peptide Drugs
Compared with small-molecule chemical drugs, peptide drugs offer higher
biological activity and specificity; and compared with protein-based drugs, they provide
stability, higher purity and lower manufacturing costs. As such, peptide drugs combine
the advantages of both modalities and address treatment across various therapeutic areas.
Globally, the peptide drug industry is gaining momentum, with several products already
approved, such as Semaglutide (USD34.5 billion), Dulaglutide (USD4.3 billion),
Tirzepatide (USD36.5 billion) and Pegcetacoplan (USD1.0 billion) in sales in 2024. Their
clinical application has expanded from metabolic diseases to a broad range of indications,
including cardiovascular, CNS, endocrine, gastrointestinal, hematological, ophthalmic
and orthopedic diseases.
Driven by continued development, the global peptide drug market is expected to
grow from USD109.6 billion in 2024 to USD267.6 billion in 2030, representing a CAGR of
13.9%. The peptide drug market in the PRC is also experiencing growth, with its market
size projected to increase from RMB60.2 billion in 2024 to RMB174.2 billion in 2030,
representing a CAGR of 20.0%. Given their precision, safety and broad therapeutic
potential, peptide drugs are well positioned to address significant unmet medical needs,
underpinning their growth trajectory.
Against this backdrop, bi-functional and multi-functional peptides have emerged as
one of the most promising directions in the peptide drug field, offering substantial
competitive barriers. Such peptides are designed to selectively modulate two or more
molecular targets through a single compound. For complex and multi-etiological diseases,
including cardiovascular and cerebrovascular diseases, metabolic disorders, central
nervous system diseases and immune-related conditions, bi- or multi-specific peptides
are capable of simultaneously targeting interrelated disease pathways, thereby producing
synergistic therapeutic effects and achieving clinical outcomes.
As a key innovator in the peptide-based therapeutic field in the PRC, we have
established a differentiated portfolio of bi/multi-functional peptide drug candidates,
particularly in the non-GLP-1 segment, where we have built technical barriers and unique
competitive advantages. Our clinical-stage multifunctional peptide assets include
MT1013, XTL6001, MT1002, MT1009. For more information of efficacy and advantages of
these clinical-stage assets, see “— Our Drug Candidates” in this section.
2. Core Product MT1013 as a Bi-functional Peptide Agonist T argeting CaSR and
OGP Receptor, with Demonstrated Improvements in Comprehensive Control
Rate and Patient Survival Benefits
MT1013 is a dual-targeting receptor agonist polypeptide that concurrently targets
the CaSR of the parathyroid gland and OGP . Through our in-house development efforts,
MT1013 is primarily designed for the treatment of CKD-SHPT, with potential for
expansion into additional indications such as CKD-MBD with osteoporosis and
CKD-SHPT not on Dialysis.
Significant improvement in comprehensive control rate of iPTH/serum
calcium/serum phosphorus levels: MT1013 has demonstrated a significant advantage in
improving the comprehensive control rate of iPTH/serum calcium/serum phosphorus
levels. In a head-to-head Phase II clinical trial against Etelcalcetide, after 26 weeks of
treatment,the proportion of subjects in the MT1013 group achieving simultaneous control
of iPTH, serum calcium and serum phosphorus was approximately 2.5 times that of
Etelcalcetide. A higher triple-target attainment rate is indicative of a substantial reduction
in all-cause mortality, more effective prevention of vascular calcification, comprehensive
bone protection and improved patient quality of life.
Fast-acting, and sustained efficacy: MT1013 has demonstrated fast-acting, and
sustained efficacy in reducing iPTH levels. Results from the Phase II clinical trials showed
significant improvement in iPTH levels shortly after treatment initiation and sustained
efficacy with continued treatment. In a head-to-head clinical trial against Etelcalcetide,
MT1013 showed favorable efficacy in achieving the target iPTH range.
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Cardiovascular benefit potential: FGF23, a key biomarker of vascular calcification
and cardiovascular risk, has been shown to correlate with improved cardiovascular
outcomes when reduced. In the head-to-head Phase II clinical trial against Etelcalcetide,
MT1013 achieved efficacy in both absolute FGF23 reduction and the proportion of subjects
with a reduction of more than 30%, consistent with its higher attainment rates of iPTH,
calcium and phosphorus, suggesting potential to substantially reduce cardiovascular
events and mortality risk.
Enhanced bone mineral density and metabolism: MT1013 has shown favorable
effects on bone health. Results from the Phase II clinical trials showed that MT1013 can
effectively improve the high-turnover bone status frequently in CKD-SHPT patients,
promote bone metabolic balance, and establish a more favorable bone remodeling profile.
These results support the clinical potential of MT1013 in treating CKD-MBD-related bone
disorders.
A favorable safety and tolerability profile: The most common adverse events
associated with existing calcimimetics are hypocalcemia and gastrointestinal reactions.
No severe hypocalcemia was observed in any of the clinical trials of MT1013. In addition,
only a small number of subjects experienced gastrointestinal adverse reactions, such as
nausea and vomiting during long-term treatment, with incidence rates lower than those
observed with existing calcimimetics. These results support the favorable safety and
tolerability profile of MT1013.
Broad potential for indication expansion: The Phase II clinical trials of MT1013
observed improvement in bone mineral density. To fully leverage the therapeutic
potential of MT1013, we have been actively expanding its indications to include
CKD-MBD with Osteoporosis and CKD-SHPT not on Dialysis. See “— Our Drug
Candidates” for more information of MT1013’s clinical results.
3. Differentiated Pipeline T argeting High-Potential Areas with Significant Unmet
Clinical Needs
We focus on addressing significant unmet clinical needs in metabolic (especially
renal-related) and cardiovascular diseases, aiming to offer effective treatment options
globally. Beyond our Core Product MT1013, we have advanced several Key Products with
differentiated mechanisms to expand treatment pathways.
Chronic Weight Management in Obese or Overweight Populations: The obesity and
weight management therapeutics market presents substantial growth opportunities,
driven by the continuously rising prevalence of obesity and associated complications. The
overweight and obesity drug market in the PRC is expected to reach RMB23.5 billion in
2030 and RMB107.3 billion in 2035, with a CAGR of 32.9% from 2030 to 2035. The GLP1R
polypeptide drug market in the PRC is estimated to reach RMB81.4 billion in 2030 and
RMB176.9 billion in 2035, with a CAGR of 16.8% from 2030 to 2035.
Against this backdrop, we are developing XTL6001, a long-acting tri-agonist
peptide drug candidate intended for the treatment of obesity, Proteinuric CKD and
MASH. Existing anti-obesity therapies face multiple limitations, including
gastrointestinal adverse events, hepatic toxicity, and impaired absorption of fat-soluble
vitamins during clinical use. GLP-1-based therapies primarily induce weight loss by
delaying gastric emptying, but are frequently associated with gastrointestinal side effects
such as nausea and vomiting, resulting in limited patient tolerance. Leveraging its
differentiated mechanism of action, XTL6001 is designed to enhance basal metabolic rate
while potentially addressing key challenges observed with single- or dual-agonist
therapies, including muscle loss, severe gastrointestinal adverse reactions, and weight
rebound following drug discontinuation. In addition, XTL6001 offers potential liver- and
kidney-protective benefits beyond weight reduction, targeting the complex comorbidity
profile commonly seen in obese patients.
ACS-PCI: ACS is an acute manifestation of CAD, continues to demonstrate a
progressively increasing incidence trend. It is estimated that by 2030 and 2035, the
incidence of ACS in China will reach 5.8 million and 6.3 million, respectively. The volume
of PCI procedures in China will reach 4.0 million and 6.0 million, respectively. The
antithrombotic drugs market in the PRC is estimated to reach RMB47.2 billion in 2030, and
RMB61.8 billion in 2035, with a CAGR of 5.6% from 2030 to 2035.
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MT1002 is the first domestically developed dual-functional antithrombotic peptide
drug with both anticoagulant and antiplatelet activities. It simultaneously targets
coagulation factor II and GPIIb/IIIa, exerting dual anticoagulant and antiplatelet effects.
Unlike conventional anticoagulants used during PCI procedures, MT1002 does not require
combination therapy and is designed to reduce both bleeding risk and the incidence of
in-stent thrombosis. It may serve as an alternative to heparin while avoiding HIT, and
addresses the unmet clinical need in emergency PCI procedures for patients who are
unresponsive to antiplatelet agents or unable to take oral medications. Results from the
Phase II clinical trial have demonstrated favorable safety and dual activity in thrombin
inhibition and platelet aggregation suppression.
AIS: AIS is the acute phase of ischemic stroke. The global prevalence of ischemic
stroke is projected to reach 127.4 million by 2035, while in the PRC it is projected to reach
35.1 million. The neuroprotective drugs market in the PRC is estimated to reach RMB15.7
billion in 2030 and RMB24.6 billion in 2035.
MT200605 is the first flavonoid-based small molecule compound that acts as an
agonist of the TrkB receptor. MT200605 promotes neural regeneration through TrkB
receptor activation and reduces free radical-induced neuronal damage via its antioxidant
effects, thereby forming a dual protective mechanism. Preclinical studies have shown that
MT200605 demonstrates good brain tissue distribution, the ability to cross the blood-brain
barrier, and efficacy in improving stroke-related behavioral outcomes and reducing
infarct volume compared with existing neuroprotective agents, supporting its therapeutic
potential and future development prospects.
Other Indications: We are advancing a tiered pipeline of product candidates
addressing unmet clinical needs to accelerate translation and capture market
opportunities. Our product candidates include MT2004 for DILI, MASLD and CLD,
MT1011 for anticoagulant reversal therapy, and MT1009 for GIOP and PMO, which
collectively strengthen and expand our portfolio in metabolic diseases (particularly
renal-related) and cardiovascular and cerebrovascular diseases. See “— Our Drug
Candidates” for more information.
4. Integrated End-to-End Platform Covering the Full V alue Chain from Discovery to
Commercialization, Enabling Accelerated Global Expansion
We have established a fully integrated system covering early target discovery,
preclinical research, clinical development and CMC process development. Our R&D and
operations headquarters is located in Xi’an, clinical and regulatory center in Beijing and
large molecule development platform in Shanghai. This structured and collaborative
network enables end-to-end capabilities from laboratory research to commercial
translation.
Platform Development
We have established four core technology platforms that operate in a coordinated
manner, encompassing our entire R&D process and establishing an integrated drug R&D
system that spans from molecular design to clinical translation. Leveraging our four
technology platforms, we have generated and developed multiple drug candidates that
have entered various stages of preclinical and clinical development, further
demonstrating the maturity and translational capability of our platforms.
• Bi-/Multi-specific Peptide and Peptidebased Macromolecule Technology Platform: The core
advantage of the platform lies in its ability to address limitations associated with
traditional single-function peptides, including restricted target engagement and
limited therapeutic outcomes. Centered on a peptide-based modular architecture,
our platform enables the integration of precise target binding, multi-target
synergistic pharmacological regulation and optimized pharmacokinetics into a
single molecular entity, making it well-suited to address the long-term treatment
needs of chronic diseases. To address the limitations of peptide drugs in metabolic
stability and biological half-life, particularly in chronic diseases requiring
long-term administration, we have established a macromolecule platform based on
functional peptides as an extension of our Bi-/Multi-functional Peptide Platform.
• Computer-aided Peptide Design Platform: The core advantage of our platform lies in its
ability to accelerate early-stage peptide drug discovery through the synergistic
application of homology modeling, molecular dynamics simulation and virtual
screening modules. This enables precise prediction of peptide–target binding
conformations, thereby shortening the discovery cycle and reducing the cost of
screening.
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• Oral Peptide Delivery Platform: The core advantage of this platform lies in its
application of solid dosage technologies, including solid dispersion, inclusion
complexation, dry granulation and direct compression. To enhance absorption of
protein and peptide drugs, the platform employs permeation enhancers and
inclusion techniques to modulate local pH, inhibit enzymatic degradation and
molecular aggregation, stabilize the microenvironment at the administration site,
preserve the active conformation of the drug, improve mucosal permeability and
enhance overall formulation stability.
• Drugability Evaluation Platform: The core advantage of this platform lies in its
comprehensive animal model coverage tailored to our pipeline and a standardized
evaluation system for safety, efficacy and pharmacokinetics. It enables in vitro
studies such as target selectivity and plasma protein binding, and in vivo
assessments including PK, PD and toxicology, supporting full-spectrum
developability evaluation in-house. The candidate molecules evaluated through
this platform have demonstrated a high success rate in clinical trial applications.
For more information on our technology platforms and the drug candidates derived
from these platforms, see “— Our Technology Platforms” in this section.
Pipeline Development
We have established a clinical development and registration system covering both
the PRC and the United States, with full-process execution capabilities for international
multi-regional clinical trials (MRCTs). Adopting a “dual China-U.S. filing and global
commercialization” model, we aim to accelerate the global time-to-market of our drug
candidates. We have established collaborations with clinical trial centers in China, the
United States and other regions to support registration trials. For our core pipeline
programs, we have generally adopted a dual China-U.S. filing strategy. As of the Latest
Practicable Date, seven drug candidates had entered clinical trials in China and/or the
United States, and six had completed dual regulatory filings in both jurisdictions. We have
built a fully functional clinical operations team and collaborate with leading international
principal investigators (PIs) and academic institutions to ensure data integrity and
registration efficiency. We have implemented a self-operated clinical trial management
model, which has demonstrated advantages in execution efficiency, data quality and cost
control, particularly in multi-program parallel settings, and has laid a solid foundation for
future multi-regional clinical development.
CMC Capability and Commercialization Strategy
We have established in-house R&D capabilities covering API and formulation
development, and are able to conduct process development without reliance on
third-party partners. As of the Latest Practicable Date, we had developed manufacturing
processes and quality standards for multiple APIs and formulations, including a
cost-effective, environmentally friendly and scalable synthetic process for the API of our
Core Product MT1013, and a scalable manufacturing process for its injectable formulation.
We have continued to optimize key steps such as solution preparation and lyophilization
to enhance product quality and consistency, while improving cost efficiency to support
future commercial production.
For commercialization, we intend to pursue a dual-track strategy combining
external partnerships and internal sales team development to gradually support product
launches. For more information of our commercialization strategy, see “Business —
Commercialization”. We believe that our integrated capabilities and experience across
product development, regulatory filings and CMC Capability will continue to support the
successful translation of our innovative drug candidates and drive the ongoing expansion
of our business scale and market competitiveness.
5. Management T eam Comprised of Experts in Peptide Drug Development
We are led by a management team with proven track record, which consists of
professionals with academic backgrounds in the peptide industry and comprehensive
experience across the entire drug development chain — from research and clinical
development to commercialization. Several members have led the development and
commercialization of multiple globally successful drugs, providing support for our
sustained development.
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Our founder, Dr. Wang Bing, holds a Ph.D. in pharmacology and has over 20 years of
experience in peptide-based drug research, with academic and scientific expertise in the
field. Dr. Wang focuses on the pathological mechanisms of cardiovascular,
cerebrovascular, metabolic, anti-inflammatory, and analgesic diseases, as well as the R&D
of novel peptide drugs.
Our management team consists of professionals with extensive industry experience.
Our Executive Director and Senior Vice President, Dr. Yu Weiping, has over 40 years of
experience in pharmaceutical R&D and senior management and is primarily responsible
for our Group’s CMC and quality control. Our Chief Medical Officer, Ms. Wang Xiangling,
has nearly 20 years of experience in the pharmaceutical industry and oversees all clinical
development and related functional operations. Our Chief Financial Officer, Mr. Zou Ran,
has more than 17 years of experience in corporate finance, management, and equity
investments, and is responsible for formulating our Group’s financial and development
strategies, as well as overall financial management and corporate development.
In addition, we have also received support from a number of institutional and
industrial investors, including Northern Light Venture Capital, NRL Capital and TASLY
Group.
OUR STRATEGIES
1. Accelerate Clinical Development and Commercialization of Our Product
Candidates
We plan to accelerate the clinical development of our Core Product and Key Product
candidates to expedite their registration in priority indications and enable
commercialisation. In parallel, we intend to leverage existing clinical and mechanistic
data to explore their potential applications in other related disease areas, with a view to
extending product lifecycle and expanding market opportunities. Specifically, we have
formulated the following development plans:
• For MT1013, we plan to pursue our first marketing approval for the treatment of
CKD-SHPT Undergoing Maintenance Hemodialysis and we expect to submit the
pre-NDA in late 2026 and the NDA in early 2027. Furthermore, we are developing
new indications for MT1013 as set forth below:
(i) CKD-MBD with Osteoporosis: We have completed Phase II clinical trial of
MT1013 for the indication of CKD-SHPT, and plan to leverage data collected
from respective trials to seek IND approvals from competent regulatory
authorities to conduct Phase III clinical trial of MT1013 for the expanded
indication of CKD-MBD with Osteoporosis. We expect to initiate the Phase III
trial for this indication in early 2028.
(ii) CKD-SHPT not on Dialysis: we plan to submit the IND application by the end
of 2027.
For more information of our future development plans, see “Business — Our Drug
Candidates — Our Core Product MT1013 — Clinical Development Plan”.
• For XTL6001, we plan to advance XTL6001 primarily for the treatment of Chronic
Weight Management in Obese or Overweight Populations, while also exploring its
potential in other metabolic diseases. We plan to initiate a Phase II clinical trial for
the treatment of Proteinuric CKD in mid 2027, and to submit an IND application for
the treatment of MASH in early 2027.
For more information of our future development plans, see “Business — Our Drug
Candidates — Our Key Product — XTL6001 — Clinical Development Plan”.
• For MT1002, following the completion of the China Phase II (MT1002-II-C04) study,
we plan to initiate an EOP II meeting with the CDE and proceed to a confirmatory
Phase III clinical trial with NACE and MACE events as primary efficacy endpoints
to support subsequent NDA submission. We have also obtained Phase II clinical trial
approvals in the PRC for additional indications, including stroke, HD and HD-PF4,
and plan to commence the Phase II clinical trials of Stroke and HD in the PRC by
June 2026 and July 2026, respectively, and to initiate the Phase II clinical trial of
HD-PF4 in the PRC at the end of 2027.
• For MT200605, we plan to complete the Phase II clinical trial of MT200605 in the PRC
in 2026. This study is a randomized, double-blind, placebo-controlled, multi-center
trial designed to evaluate the efficacy, safety and pharmacokinetic profile of
MT200605 in patients with AIS. As of the Latest Practicable Date, enrollment of 360
subjects has been completed.
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2. Focus on Clinical Needs and Advance Peptide Drug Candidates with
Differentiated Mechanisms and Commercialisation Potential
Leveraging our deep industry knowledge in the peptide field, extensive R&D
experience, and forward-looking product strategy, we will continue to focus on major
disease areas such as metabolic disorders (particularly renal-related) and cardiovascular
and cerebrovascular diseases to develop differentiated treatment solutions with
differentiated advantages.
3. Deepen Strategic Collaborations to Unlock the Clinical and Commercial Potential
of Our Product Candidates
With a portfolio of assets advancing in global clinical development, we have been
actively seeking collaboration opportunities to accelerate their clinical progress and
commercialization. In the PRC, we are advancing the clinical studies of our pipeline
candidates, while also planning to establish partnerships to expedite development and
expand into major international markets.
We intend to form strategic collaborations with industry participants both
domestically and overseas to drive commercialization and enhance our global market
potential. In addition, we will continue to explore and evaluate external collaboration
models such as license-out, co-development and the establishment of new joint ventures
(NewCo). For more information of our commercialization strategy, see “Business —
Commercialization”.
4. Recruit and Retain T alent to Promote Systematic T raining and Sustainable
Development.
The majority of our Board members possess extensive backgrounds in the medical
field and substantial industry experience, and place emphasis on the selection and
development of professional talent. To further enhance our market competitiveness, we
will continue to bring in additional experts specialized in drug research, clinical
development, commercialization, and other critical functions, injecting renewed vitality
into our Company’s long-term growth. For our existing team, we regularly organize
systematic training programs designed to align individual career development with our
Company’s future objectives, ensuring mutual growth and consistent progress.
OUR DRUG CANDIDATES
Leveraging our expertise in polypeptide therapies and relying on our four major
technology platforms, we independently develop dual-target and multi-target specific
polypeptide drugs. As of the Latest Practicable Date, we have established an extensive
pipeline of drugs under development. The diagram below summarises the development
progress of our clinical-stage drug candidates:
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Core product Key product
MT200605
Drug Candidates Target/Mechanism Indication RegionTreatment
regimen
IND and IND
Preparation Phase I Phase II Phase III Current Status/Projected Milestones Commercialization
Rights
Metabolic drugs
CaSR/OGP
CKD-SHPT
PRC Complete Phase III clinical trial
by the end of 2026 Global(2)
U.S.
CKD-MBD with Osteoporosis PRC Commence Phase III clinical trial
in early 2028
(1)
Global
CKD-SHPT not on Dialysis PRC File IND by the end of 2027
GLP-1R/
GCGR/MasR
Weight management for
obesity or overweight
PRC Complete Phase I clinical trial
in Q2 of 2026
U.S.
Proteinuric CKD PRC Complete Phase I clinical trial
in Q2 of 2026
MASH PRC File IND in early 2027
MT2004 FXR
(small-molecule)
DILI PRC Complete Phase II clinical trial
by the end of 2027
MASLD
PRC
U.S.
CLD PRC Commence Phase II clinical trial
by the end of 2027
(3)
PTH1R/OGP
GIOP
PRC Commence Phase I clinical trial
in January 2026
U.S.
PMO
PRC Commence Phase I clinical trial
in January 2026
U.S.
Cardio-cerebrovascular drugs
Coagulation
Factor II/
GP IIb/IIIa
ACS-PCI PRC Complete Phase IIb
(4) clinical trial
by mid-2028
Global
U.S.
Stroke PRC Commence Phase II clinical trial(5)(6)
by June 2026
HD
PRC Commence Phase II clinical trial(5)(7)
by July 2026
U.S.
HD-PF4 PRC Commence Phase II clinical trial
by the end of 2027
(5)
TrKB
(small-molecule) AIS
PRC Complete Phase II clinical trial in 2026
U.S.
MT1011 NOACs
(small-molecule)
Universal Anticoagulant
Reversal Agent PRC
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy
Monotherapy Complete Phase I clinical trial
in Q2 of 2026
MT1013
XTL6001
MT1009
MT1002
Directly proceed to the next stage Currently evaluating the competitive landscape and formulating the future Clinical Development Plan
Abbreviation: CaSR: Calcium-Sensing Receptor; OGP: Osteogenic Growth Peptide; CKD-MBD: Chronic Kidney Disease-Mineral and Bone Disorder; GLP-1R: Glucagon-like Peptide-1 Receptor; GCGR: Glucagon Receptor; MasR: Mas Receptor;
MASH: Metabolic Dysfunction-associated Steatohepatitis; FXR: Farnesoid X Receptor; DILI: Drug-Induced Liver Injury; MASLD: Metabolic Dysfunction-associated Steatotic Liver Disease; CLD: Cholestatic Liver Disease; PTH1R: Parathyroid hormone 1 receptor; GIOP: Glucocorticoid-Induced Osteoporosis;
PMO: Postmenopausal Osteoporosis; GP IIb/IIIa: Glycoprotein IIb/IIIa Complex; ACS: Acute Coronary Syndrome; PCI: Percutaneous Coronary Intervention; HD: hemodialysis; HD-PF4: HD with heparin-platelet factor 4 complex positive; PF-4: Platelet Factor-4; AIS: acute ischemic stroke; TrkB:
Tyrosine kinase receptor B; NOACs: Novel Oral Anticoagulants
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Notes:
(1) We have completed Phase II clinical trial of the relevant product for the indication of CKD-SHPT, and as patients with CKD-SHPT are all within the CKD-MBD
population, we plan to leverage data collected from respective trials to seek IND approvals from competent regulatory authorities to conduct Phase III clinical trial
of the relevant product for the expanded indication of CKD-MBD with Osteoporosis.
(2) Researched and developed in-house. We have granted Everest Medicines (China) Co., Ltd. (“ Everest”) the exclusive right to sell, commercialize and promote MT1013
for the treatment of CKD-SHPT in Mainland China, Hong Kong, Macao and the Taiwan region as well as the Asia-Pacific region (excluding Japan) (the “ T erritory”).
We reserved the rights to: (i) research, develop and manufacture MT1013 globally; (ii) commercialize MT1013 for any indications outside Territory; and (iii)
commercialize MT1013 in the Territory for any indications other than CKD-SHPT. For more information, see “Business — Commercialization”.
(3) The Phase I clinical trial of MT2004 had conducted adequate safety and dose-ranging evaluation to support the therapeutic dose range for the treatment of MASLD
and CLD in the PRC, thereby providing the basis for directly commencing the respective Phase II clinical trials.
(4) The Phase IIb clinical trial forms part of MT1002-II-C04 and was conducted to further evaluate the selected dose(s) in a larger patient population. For more
information, see “Business — Our Key Product MT1002 — Clinical Trial Overview of MT1002 — MT1002-II-C04 PRC Phase II Efficacy Study in ACS-PCI Patients ”.
(5) The Phase I clinical trial of MT1002 had conducted adequate safety and dose-ranging evaluation to support the therapeutic dose range for the treatment of stroke, HD
and HD-PF4 in the PRC, thereby providing the basis for directly commencing the respective Phase II clinical trials.
(6) In June 2023, we obtained IND approval from the NMPA to conduct a Phase II clinical trial of MT1002 for stroke. Trial preparation was initiated in March 2026,
including the finalization of the clinical trial protocol.
(7) In July 2023, we obtained IND approval from the NMPA to conduct a Phase II clinical trial of MT1002 for HD. Trial preparation was initiated in March 2026, including
the finalization of the clinical trial protocol.
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Our Core Product — MT1013
Our Core Product, MT1013, is a dual-targeting receptor agonist polypeptide that
adopts an OGP-like structure and simultaneously activates the CaSR and mimics the OGP
mechanism. It targets two key pathogenic links of CKD-SHPT/CKD-MBD by acting on the
CaSR in the parathyroid gland and concurrently on disease-related OGP . It
simultaneously regulates the two key metabolic pathways of calcium and phosphorus,
demonstrating advantages in regulating the key indicators of calcium and phosphorus
metabolism, thereby achieving the dual synergistic benefits of both calcimimetic and
pro-osteogenic effects. This distinguishes it from traditional single-target calcimimetics,
which directly regulate iPTH but lack a direct pro-osteogenic effect. MT1013 is primarily
developed for the treatment of CKD-SHPT, with planned expansion to indications such as
CKD-MBD with Osteoporosis and CKD-SHPT not on Dialysis.
Mechanism of Action
MT1013 adopts an OGP-like structure and simultaneously activates the CaSR and
mimics the OGP mechanism, thereby targeting and controlling CKD-SHPT and related
bone disorders. On one hand, by activating the CaSR on the surface of parathyroid cells,
MT1013 mimics the action of calcium ions to inhibit the synthesis and secretion of iPTH,
thus lowering iPTH levels to counteract the damage to bone and kidneys caused by high
iPTH; reducing Ca reabsorption in the renal tubules and increasing urinary Ca excretion.
On the other hand, its OGP-like structure promotes the proliferation and differentiation of
osteoblasts, enhances alkaline phosphatase activity, and facilitates bone matrix
mineralization, which helps to ameliorate osteoporosis and treat renal osteodystrophy.
Through this synergistic CaSR+OGP mechanism, MT1013 can achieve comprehensive
regulation of iPTH, serum calcium, and serum phosphorus in CKD-SHPT patients,
resulting in a higher comprehensive control rate and providing cardiovascular protection
benefits; improving bone metabolism and addressing the challenge of the lack of effective
treatment for renal osteodystrophy in patients with CKD (G5D) and concomitant
CKD-SHPT.
iPTH
CaSR
CaSR
Activation:
OGP Activation:
1,25 Vit D
Secretion Resorption
Excretion
Absorption
Serum
calcium
Alkaline phosphatase/
Matrix mineralization
Differentiation
Proliferation
Accessory Domain
OGP protein structure
Active Domain (10-14)
α2M
Source: Company data
CaSR isaGp r otein-coupled receptor distributed in parathyroid glands, kidneys,
and other tissues, and its core function is to sense changes in extracellular calcium ion
concentration and regulate the secretion of iPTH through negative feedback to maintain
calcium metabolism homeostasis. In CKD-SHPT, the abnormal decrease in extracellular
calcium concentration due to impaired phosphorus excretion and decreased calcium
absorption caused by chronic kidney disease will weaken the CaSR’s ability to sense
calcium, making it unable to effectively inhibit iPTH secretion; at the same time,
long-term calcium-phosphorus disorders will stimulate the proliferation of parathyroid
glands, which will further reduce the sensitivity of the CaSR, forming a iPTH. At the same
time, long-term calcium and phosphorus disorders will stimulate parathyroid
hyperplasia, further reducing CaSR sensitivity, forming a vicious cycle of “iPTH
over-secretion — parathyroid hyperplasia”, aggravating bone metabolism abnormalities
and cardiovascular damage.
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OGP is an active peptide involved in the regulation of bone metabolism, which can
promote the proliferation of osteoblasts, enhance osteogenic activity, stimulate the
synthesis of collagen and the formation of bone matrix, and regulate the process of bone
formation. OGP has the potential to counteract the symptoms of CKD-SHPT-induced bone
resorption hyperactivity and inhibition of bone formation, and indirectly stabilizes the
blood calcium level by reducing the excessive release of calcium from the bone through
the promotion of bone formation, thus alleviating the stimulation of parathyroid gland by
the loss of calcium from the bone.
Source:
(1) Bab, I.; Gazit, D.; Chorev, M.; Muhlrad, A.; Shteyer, A.; Greenberg, Z.; Namdar, M.; Kahn, A.
Histone H4-related osteogenic growth peptide (OGP): a novel circulating stimulator of
osteoblastic activity. EMBO J 1992, 11, 1867-1873
(2) Pigossi SC, Medeiros MC, Saska S, Cirelli JA, Scarel-Caminaga RM. Role of Osteogenic Growth
Peptide (OGP) and OGP(10-14) in Bone Regeneration: A Review. Int J Mol Sci. 2016 Nov
22;17(11):1885.
Market Opportunities and Competition
CKD-SHPT
CKD-SHPT is a parathyroid dysfunction caused by disorders in calcium,
phosphorus, and vitamin D metabolism, characterized by parathyroid hyperplasia and
excessive secretion of iPTH. CKD-SHPT is particularly common in patients with CKD in
middle and advanced stages, seriously endangering patients’ quality of life and lifespan.
In 2025, the global number for CKD-SHPT patients reached 160.4 million, and is expected
to increase to 188.0 million by 2030. As of the Latest Practicable Date, there are two CaSR
agonist drugs approved by FDA and three CaSR agonist drugs approved by NMPA. In
addition, there are five CaSR agonist drug candidates for CKD-SHPT in the clinical stage
globally, including MT1013 (currently in Phase III). For more information, see “Industry
Overview — Competitive landscape of CaSR agonist.”
CKD-SHPT is caused by CKD as the primary disease, and its therapeutic approach
must be determined on an individualized basis, taking into account the stage of the
underlying disease, disease severity, serum calcium and phosphate levels, vitamin D
metabolism, the degree of PTH elevation and comorbidities. Therapy of CKD-SHPT is
primarily symptomatic and progressive in nature, following a stepwise and
comprehensive treatment principle. Accordingly, treatment options vary according to
individual patient conditions, including phosphate-lowering therapy, vitamin D or
vitamin D analogues and calcimimetics etc. The foregoing treatment principles are
consistent with prevailing international and domestic clinical guidelines and published
reviews, including the KDIGO 2017 Clinical Practice Guideline Update for CKD-MBD and
the Chinese Guidelines for the Diagnosis and Treatment of Chronic Kidney
Disease-Mineral and Bone Disorder, neither of which classifies CKD-SHPT treatment into
formal first-line, second-line or subsequent-line therapies. Frost & Sullivan further
confirmed that there is no formal classification of CKD-SHPT treatment into any line of
treatment.
CKD-MBD with Osteoporosis
The global prevalence of CKD-MBD grew from 291.7 million in 2020 to 342.8 million
in 2025, and is projected to reach 403.0 million by 2030 and 470.3 million by 2035. The
prevalence of CKD-MBD in China grew from 47.0 million in 2020 to 50.6 million in 2025,
and is projected to reach 54.1 million by 2030 and 57.4 million by 2035.
CKD-SHPT not on Dialysis
The global prevalence of CKD-SHPT not on hemodialysis grew from 133.2 million in
2020 to 156.5 million in 2025. It is projected to reach 185.3 million by 2030 and 216.2 million
by 2035. In China, the number of CKD-SHPT patients not on hemodialysis grew from 12.3
million in 2020 to 12.9 million in 2025, and is projected to reach 13.1 million by 2030.
Competitive Advantages
(1) Significant improvement in comprehensive control rate of iPTH/serum calcium/serum
phosphorus levels
Numerous studies suggest that when targets for the three indicators of iPTH, serum
calcium, and serum phosphorus are simultaneously met, the risks of hospitalisation due
to cardiovascular disease, cardiac death and all-cause mortality are significantly lower for
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patients compared to when targets for only two or one of these indicators are met. In a
Phase II head-to-head clinical study against Etelcalcetide, MT1013 demonstrated that
after 26 weeks of treatment, it not only potently lowered iPTH and maintained serum
calcium within the normal range, but also significantly reduced serum phosphorus,
outperforming Etelcalcetide (MT1013 groups: 11.2%-11.6% vs. Etelcalcetide: 5.3%), with a
phosphorus-lowering effect 2.1 to 2.2 times greater. Consequently, the proportion of
subjects achieving the simultaneous targets for the three indicators of iPTH, serum
calcium, and serum phosphorus (iPTH: 2-9 times the upper limit of normal (130-586
pg/mL); serum calcium: 2.10-2.50 mmol/L; serum phosphorus: 1.13-1.78 mmol/L) was
higher than the existing single-target calcimimetic Etelcalcetide (MT1013 groups:
34.48%-39.29% vs. Etelcalcetide: 15.63%), with the comprehensive control rate for the two
MT1013 dose groups being 220%-251% of that of the single-target calcimimetic
Etelcalcetide. A higher comprehensive control rate suggests a significant reduction in
all-cause mortality, effective prevention of vascular calcification, comprehensive
maintenance of skeletal health, and improved quality of life for patients. For more
information of the clinical results, see “— Clinical Trial Overview of MT1013” below in
this section.
Comprehensive Control Rate
of iPTH, Ca, P (%)
MT1013-G1 MT1013-G2 Etelcalcetide
15.63%
34.48%
39.29%
Higher than Etelcalcetide 251%; P=0.0482
Higher than Etelcalcetide 220%
0
10
20
30
40
50
Figure: Comprehensive Control Rate of iPTH, Serum Calcium (Ca),
and Serum Phosphorus (P) by Group during Weeks 20-27 (%)
Comprehensive Control Rates: Week 20-27,
iPTH: 2-9 times the upper limit of normal (130-586 pg/mL);
serum calcium: 2.10-2.50 mmol/L; Serum Phosphorus: 1.13-1.78 mmol/L
Note: EAP treatment group N=28-32/group
(2) Fast-acting, and sustained efficacy in reducing iPTH
The iPTH-lowering effect of MT1013 is characterised by early onset, potent
achievement of targets, and long-lasting, stable efficacy; therefore, earlier use by patients
leads to earlier benefits. Based on the results of two clinical studies (II-C01/C02), it was
observed that after 3 weeks of treatment, iPTH levels in one-third of the subjects had
decreased by over 30%; after 9 weeks of treatment, a stable state of efficacy was achieved,
with nearly 80% of patients showing an iPTH reduction of over 30%. After 26 and 52
weeks of continuous treatment, the proportion of patients with an iPTH reduction of >30%
reached 80%-90%, and the proportion with an iPTH reduction of >50% reached 65%-70%.
Based on the results of a dual-controlled clinical study with placebo and
Etelcalcetide as the active comparator (MT1013-II-C03), a head-to-head comparison
showed that 54.8%–56.7% of subjects in the MT1013 groups achieved the ideal iPTH
standard (150≤iPTH≤300 pg/ml), which was higher than the 43.8% in the Etelcalcetide
group. Furthermore, MT1013 demonstrated greater advantages in patients with severe
CKD-SHPT (baseline iPTH >600 pg/ml). MT1013 group 2 reduced iPTH by 69.6% from a
baseline mean of 938.5 pg/ml to a mean of 274.2 pg/ml (within the
guideline-recommended ideal target range of 150-300 pg/ml), which was significantly
higher than Etelcalcetide (a 61.8% reduction from a baseline mean of 912.5 pg/ml to 350.7
pg/ml, which did not reach the guideline-recommended ideal target range of 150-300
pg/ml). For more information of the clinical results, see “— Clinical Trial Overview of
MT1013” below in this section.
(3) Cardiovascular benefit potential
High iPTH, hypercalcemia, and hyperphosphatemia are significantly associated
with the risks of cardiovascular events, fractures, and mortality, and have become one of
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the major risk factors for complications in CKD-MBD patients. In clinical studies, MT1013
has demonstrated comprehensive control of high iPTH, hypercalcemia, and
hyperphosphatemia within target ranges. This suggests the potential to reduce the risk of
cardiovascular events in CKD-SHPT patients, thereby achieving potential cardiovascular
protection benefits. FGF23, an indicator of vascular calcification recommended by the
2017 KDIGO CKD-MBD guidelines, is also a key indicator for assessing cardiovascular
risk. The EVOLVE study demonstrated that a >30% reduction in FGF-23 from baseline in
the target population is associated with improved cardiovascular outcomes (reduced risk
of cardiovascular mortality, heart failure, and sudden death). In the head-to-head study
between MT1013 and Etelcalcetide, it was observed that MT1013 was higher than
Etelcalcetide in both the absolute reduction of FGF-23 and the proportion of subjects with
a >30% reduction in FGF-23. This trend is consistent with its composite endpoint
achievement rate for iPTH/serum calcium/serum phosphorus compared to Etelcalcetide.
This indicates that MT1013 has the potential to significantly reduce the incidence of
cardiovascular events and the risk of mortality. For more information of the clinical
results, see “— Clinical Trial Overview of MT1013” below in this section.
Source:
(1) Tentori F, Blayney MJ, Albert JM, Gillespie BW, Kerr PG, Bommer J, Young EW, Akizawa T, Akiba
T, Pisoni RL, Robinson BM, Port FK. Mortality risk for dialysis patients with different levels of
serum calcium, phosphorus, and iPTH: the Dialysis Outcomes and Practice Patterns Study
(DOPPS). Am J Kidney Dis. 2008 Sep;52(3):519-30
(2) Block GA, Kilpatrick RD, Lowe KA, Wang W, Danese MD. CKD-mineral and bone disorder and
risk of death and cardiovascular hospitalization in patients on hemodialysis. Clin J Am Soc
Nephrol. 2013 Dec;8(12):2132-40
(4) A favorable safety and tolerability profile with no new safety signals observed beyond those
associated with calcimimetics.
The most common adverse events associated with existing calcimimetics are
hypocalcemia and gastrointestinal adverse reactions: (i) No severe hypocalcemia occurred
in any of the MT1013 clinical trials; (ii) In the MT1013-II-C01 and C02 studies, after
receiving MT1013, as iPTH levels decreased, the hypercalcemic state of subjects improved,
and Ca levels gradually declined. After 52 weeks of continuous treatment, the mean
corrected calcium levels of the subjects remained consistently within the normal range;
(iii) In the head-to-head study with Etelcalcetide, the incidence of hypocalcemia in the
MT1013 groups was significantly lower than in the Etelcalcetide group (7.7% vs. 12.1%);
(iv) In the head-to-head study with Etelcalcetide, the incidence of adverse reaction
leading to temporary drug discontinuation in the MT1013 group was lower than that of
the Etelcalcetide group (MT1013: 27.7% vs. Etelcalcetide: 33.3%); and (v) In the
MT1013-II-C01 and C02 studies, a total of 133 subjects were treated for up to 52 weeks. The
incidences of the gastrointestinal adverse reactions of nausea (1.5%) and vomiting (1.5%)
were both significantly lower than those of existing calcimimetics.
0
5
10
15
Incidence of Hypocalcemia (%)
Placebo MT1013
C01+C02
MT1013
C03
Etelcalcetide
C03
12.1%
7.7%
6.8%
0%
Figure: Incidence of Hypocalcemia in Each Group of MT1013-II-C01/C02 and
MT1013-II-C03 Studies (%)
MT1013-II-C01+C02 jMT1013 N=133
MT1013-II-C03: MT1013 group 1/33 subjects, MT1013 group 2/32 subjects, etelcalcetide/33 subjects,
placebo group/16 subjects
Source: Company data
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For more information of the clinical results, see “— Clinical Trial Overview of
MT1013” below in this section.
(5) Enhanced bone mineral density and metabolism
In the Phase II study (II-C01), subjects with baseline bone mass
reduction/osteoporosis showed a significant increase in lumbar spine and femoral neck
bone mineral density after 24 and 52 weeks of treatment with MT1013 (at 52 weeks of
treatment, lumbar spine increased by 1.65% and femoral neck by 4.44% from baseline).
Bone turnover markers (b-ALP , OC, PINP , CTX, TRAP-5b) in all subjects were
significantly reduced relative to baseline (at week 53, ALP decreased by 27.06% and
TRAP-5b by 45.55%), indicating that MT1013 significantly ameliorated the high bone
turnover state in CKD-SHPT patients, improved bone metabolism, and established better
bone balance. This demonstrates its promising clinical application prospects in the field of
CKD-MBD-related bone diseases. For more information of the clinical results, see “—
Clinical Trial Overview of MT1013” below in this section.
Summary of Clinical Trial Results
The table below sets out a summary of the completed and ongoing clinical trials for
MT1013:
Study ID Study Phase Location
No. of
(Planned)
Subjects Dosing Period Primary Study Design Status
MT1013-I-A01 .......... Phase I U.S. 40 Single dose Healthy Subjects
SAD: 2.5 mg, 5 mg, 10 mg,
15 mg, 20 mg
Completed in
October
2021
MT1013-I-C02
(1) ......... Phase I PRC 44 Single dose Healthy Subjects
SAD: 1.25 mg, 2.5 mg,
5 mg, 10 mg, 15 mg, 20 mg
Completed in
September
2022
MT1013-I-C03
(2) ......... Phase I PRC 4-6 Single-dose
administration
on Day 1;
continuous
dosing from
Week 6 for 3
weeks.
Patients with CKD-SHPT
Undergoing Maintenance
Hemodialysis in the PRC; A
single-center,
non-randomized, open-label
study design
Ongoing
MT1013-II-C01
(1) . . . SAD Phase II PRC 40 Single dose Patients with CKD-SHPT
Undergoing Maintenance
Hemodialysis
SAD: 5mg, 10 mg, 20 mg,
40 mg, 60 mg
Completed in
May 2025
MAD 24 2w/4w Patients with CKD-SHPT
Undergoing Maintenance
Hemodialysis
MAD: 5 mg (2w), 10 mg
(4w),
20 mg (4w)
Long-term
cohort
33 52w Patients with CKD-SHPT
Undergoing Maintenance
Hemodialysis, single-arm;
titrated dosing
MT1013-II-C02
(2) ......... Supportive
Phase III,
registered
as IIb
PRC 350 52w Patients with CKD-SHPT
Undergoing Maintenance
Hemodialysis, single-arm;
titrated dosing; safety as the
primary endpoint; efficacy as
the secondary endpoint
Ongoing
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Study ID Study Phase Location
No. of
(Planned)
Subjects Dosing Period Primary Study Design Status
MT1013-II-C03
(1)(3) ........ Phase II PRC 114 26w Patients with CKD-SHPT
Undergoing Maintenance
Hemodialysis, randomized,
active comparator
(Etelcalcetide) and
placebo-controlled, titrated
dosing; efficacy as the
primary endpoint
Completed in
March 2026
MT1013-III-C01
(1) ......... Phase III PRC 424 26w Patients with CKD-SHPT
Undergoing Maintenance
Hemodialysis; multicenter,
randomized, double-blind,
double-dummy, with
cinacalcet as the active
comparator
Ongoing
Notes:
(1) Clinical trials that are registrational or for advancing the Core Product to the next phase of clinical
trial/NDA in the PRC. For details of each clinical trial, see “— Clinical Trial Overview of MT1013” below
in this section.
(2) Clinical trials that are supplementary and voluntary in nature and intended to provide supportive
clinical data as part of the overall clinical data package for the NDA in the PRC. For details of each
clinical trial, see “— Clinical Trial Overview of MT1013” and “— Material Communications” below in
this section.
(3) (i) During the EOP2 communication meeting with the CDE in July 2024, the CDE recommended that the
Company conduct a small-scale comparative study of MT1013 against Etelcalcetide and placebo, with a
treatment period of approximately 14 to 16 weeks to observe efficacy, and did not require completion of
MT1013-II-C03 as a prerequisite for commencement of the Phase III clinical trial. (ii) MT1013-II-C03 was
designed by the Company with a 26-week treatment period in order to facilitate a more comprehensive
evaluation of the efficacy and safety profile. As of the June 2025 EOP2 communication meeting, 22-week
data from MT1013-II-C03 had already been obtained, which exceeded the 14-to-16-week treatment period
recommended by the CDE and sufficiently reflected the efficacy and safety profile of MT1013. The CDE
considered that, based on the available Phase II clinical data submitted by our Company, MT1013
demonstrated efficacy comparable with marketed drug products and agreed that we could proceed to the
Phase III clinical trial, notwithstanding that MT1013-II-C03 had not yet been completed.
Clinical Trial Overview of MT1013
MT1013-I-A01 U.S. Phase I Study
Overview: This study was a Phase I clinical study with single ascending doses
conducted in healthy subjects in the U.S. The primary objective was to evaluate the safety
and tolerability, and the secondary objective was to characterize the pharmacokinetics and
pharmacodynamics of MT1013.
T rial design: A single-center, randomized, placebo-controlled, double-blind, single
ascending dose study, comprising five dose cohorts with dose levels of 2.5, 5, 10, 15, and
20 mg, respectively. Each subject received a single-dose administration. Cohorts received
treatment sequentially in an ascending dose manner, with each cohort comprising 8
subjects (6 subjects receiving the active investigational drug and 2 subjects receiving a
matching placebo). Subjects underwent a follow-up visit on Day 8 (±1 day).
A total of 40 subjects were enrolled in the US in this trial. The key inclusion criteria
included, among others: (1) male or female non-smokers aged between 18 and 55 years,
with a body mass index (BMI) greater than 18.0 kg/m² and less than 30.0 kg/m², and a
body weight of no less than 45.0 kg; and (2) healthy subjects without clinically significant
medical history or conditions. The key exclusion criteria included but were not limited to:
(1) any clinically significant abnormalities identified during physical examination at
medical screening, including abnormal laboratory test results, or positive findings for
HIV , hepatitis B virus (HBV), hepatitis C virus (HCV) or Treponema pallidum antibody;
and (2) other clinically significant abnormalities identified during screening, including
abnormalities in ECG, vital signs or laboratory findings.
T rial status: The Phase I clinical trial was conducted in the United States, with the
first subject receiving the first dose in June 2021 and the last subject completing the last
visit in October 2021.
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Pharmacokinetics (PK) results: The geometric mean values of PK exposure
parameters for each dose level were as follows: AUC 0-t were 205.87, 435.43, 714.29,
1,328.67, and 1,602.78 h*ng/mL, respectively; AUC 0-inf were 211.97, 447.68, 729.02,
1,340.27, and 1,625.27 h*ng/mL, respectively; C max were 197.20, 425.70, 576.72, 1,128.90,
and 1,218.03 ng/mL, respectively, with the mean T max ranging from 0.114 to 0.181 hours.
Results from a power model analysis indicated that exposure increased proportionally
with the dose in the 2.5–20 mg range.
Safety data: In healthy subjects, single intravenous (IV) administration of MT1013
in the dose range of 2.5 mg to 20 mg was well tolerated. Among the 40 subjects who
received any dose of MT1013 or placebo, 3 subjects (7.5%) reported a total of 4 TEAEs.
Among the 30 subjects who received any dose of MT1013, 2 subjects (6.66%) reported 3
TEAEs, and among the 10 subjects who received placebo, 1 subject (10%) reported 1 TEAE.
A total of 3 subjects (7.5%) reported headache, and 1 subject reported nausea. All TEAEs
reported during the study were mild in severity. No moderate or severe TEAEs were
reported. Of these 4 TEAEs, 3 were considered unrelated, and 1 (headache) was
considered related to MT1013. No drug-related SAEs were reported. No life-threatening
AEs occurred, nor did any AE lead to patient withdrawal or study discontinuation.
Efficacy data: At different doses from 2.5 to 20 mg, MT1013 significantly reduced
serum iPTH, with maximum inhibition rates of 32.1%, 19.8%, 66.6%, 63.0%, and 74%,
respectively. The reduction was reversible, with levels gradually recovering after 6 hours.
The preliminary pharmacodynamic effect lasted for 24 - 48 hours. In the placebo group,
iPTH levels ranged from 11.70 to 98.50 pg/ml. For MT1013, at different doses and time
points, iPTH levels ranged from 5.30 to 82.90 pg/ml.
MT1013-I-C02 PRC Phase I Study
Overview: This study was a Phase I clinical study with single ascending doses in
healthy adult subjects in the PRC. Its objective was to evaluate the safety, tolerability,
pharmacokinetics, and preliminary pharmacodynamics of MT1013.
T rial design: A single-center, randomized within each dose group,
placebo-controlled, double-blind, single ascending dose study. Six dose groups were
designed within the 1.25 mg to 20 mg range. Group A1 consisted of 4 subjects
(investigational drug: placebo = 3:1), and groups A2-A6 each consisted of 8 subjects
(investigational drug: placebo = 6:2). The trial proceeded from the lowest dose group to
the highest. Subjects underwent a safety assessment on Day 3 and were discharged from
the study thereafter.
A total of 44 subjects were enrolled in the PRC in this trial. The key inclusion criteria
included: (1) male or female healthy subjects of Chinese nationality with an appropriate
gender ratio; (2) aged between 18 (inclusive) and 45 (inclusive) years; and (3) body weight
of no less than 50.0 kg for male subjects and no less than 45.0 kg for female subjects, with
a body mass index (BMI) between 19.0 kg/m² and 26.0 kg/m² (inclusive). The key
exclusion criteria included but were not limited to: (1) subjects with clinically significant
abnormalities in cardiovascular, hepatic, renal, endocrine, metabolic, gastrointestinal,
hematologic or respiratory laboratory findings as determined by the investigator, or with
a confirmed diagnosis of any of the above diseases, or with a history of infections,
malignancy or psychiatric disorders; (2) subjects with a history of clinically significant
ECG abnormalities or long QT syndrome, or a history of epileptic seizures; and (3)
subjects with clinically significant abnormalities in physical examination, vital signs,
laboratory tests or ECG results, as determined by the investigator.
T rial status: The Phase I clinical trial was initiated in January 2022 and completed in
September 2022.
Pharmacokinetics (PK) results: For the 1.25 mg to 20 mg MT1013 dose groups, the
geometric mean C
max values were 129.28, 284.91, 537.21, 1,038.90, 1,570.64, and 2,264.62
ng/mL, respectively; the geometric mean AUC 0-t values were 97.75, 194.04, 350.78, 709.75,
1,110.29, and 1,723.16 ng·h/mL, respectively; and the geometric mean t 1/2 values were
1.18, 1.30, 1.13, 1.16, 1.29, and 1.47 h, respectively. A power model was used for linear
pharmacokinetic analysis of blood PK parameters (C
max, AUC0-t, AUC0-Ü), which met the
criteria for linear pharmacokinetics.
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Safety data: MT1013 demonstrated good safety and tolerability. The number of
subjects with adverse reactions (and incidence rates) in the MT1013 1.25 mg, 2.5 mg, 5 mg,
10 mg, 15 mg, 20 mg, and placebo groups were 1 (33.3%), 4 (66.7%), 4 (66.7%), 5 (83.3%), 4
(66.7%), 6 (100.00%), and 6 (54.5%), respectively. There was no significant association
between AE incidence or severity and the administered dose. No drug-related TEAEs of
Grade 3 or above were observed, and no drug-related SAEs were reported. No
life-threatening AEs occurred, nor did any AE lead to patient withdrawal or study
discontinuation.
Efficacy data: In the MT1013 1.25 mg to 20 mg groups, serum parathyroid hormone
levels began to decrease after intravenous bolus injection of MT1013, reaching a nadir
approximately 6 hours post-injection. At this time point, the percentage change from
baseline in serum parathyroid hormone concentration for the placebo group and the
various dose groups were -36.42(16.80)%, -46.42(19.12)%, -39.99(17.75)%, -52.65(7.96)%,
-68.51(7.07)%, -71.51(5.74)%, and -80.35(5.98)%, respectively. Serum parathyroid hormone
levels reached their nadir 6 hours after a single intravenous bolus injection of MT1013.
This pharmacodynamic effect lasted for up to 24 hours and returned to baseline by 48
hours.
MT1013-I-C03 PRC Phase I Mass Balance Study
Overview: This is an in vivo mass balance study conducted in the PRC in patients
with CKD-SHPT Undergoing Maintenance Hemodialysis. Its objective was to
quantitatively analyze the total radioactivity and radioactive metabolite profile in excreta,
as well as the pharmacokinetic parameters and safety, after intravenous injection of
[
14C]MT1013.
T rial design: A single-center, non-randomized, open-label study design. During the
first week, a single intravenous dose of [ 14C]MT1013 (comprising 10 mg of non-labeled
MT1013 and approximately 50 μCi of radiolabeled compound) was administered after the
first hemodialysis session. Beginning from Week 6, MT1013 was administered
intravenously after each of the three weekly hemodialysis sessions for a total duration of
three weeks, with the final dose given after the first hemodialysis session in Week 9, at a
dose of 5 mg per administration. Subjects entered a follow-up period of one week
thereafter. The study is planned to enroll 4-6 participants in the PRC with CKD-SHPT
Undergoing Maintenance Hemodialysis.
The key inclusion criteria included: (1) male or postmenopausal female participants
aged 18 years or above who were clearly diagnosed with CKD-SHPT; (2) BMI between 18.0
kg/m² and 35.0 kg/m² (based on pre-dialysis body weight); and (3) subjects who had
received adequate and regular hemodialysis for at least 12 weeks prior to screening and
had undergone sufficient dialysis within four weeks prior to screening. The key exclusion
criteria included but were not limited to: (1) subjects who had undergone
parathyroidectomy within six months prior to screening, or who planned to undergo
parathyroidectomy, ablation, radiation or other related procedures during the study
period; (2) subjects with a history of gastrointestinal bleeding or peptic ulcer within six
months prior to screening; and (3) subjects who had experienced myocardial infarction or
undergone percutaneous coronary intervention or coronary artery bypass grafting within
six months prior to screening.
T rial status: The trial was initiated in July 2025. As of the Latest Practicable Date, all
subjects had completed the trial.
MT1013-II-C01 Phase II Single- and Multiple-Ascending Dose and 52-week Long-term Treatment
Study in the Target Population
Overview: This was a Phase II clinical study conducted in patients with CKD-SHPT
Undergoing Maintenance Hemodialysis, aiming to evaluate the safety, efficacy and
pharmacokinetics of MT1013 after a single dose, continuous dosing for 2-4 weeks, and
long-term continuous dosing for 52 weeks in HD subjects with CKD-SHPT. Safety
evaluation was the primary objective of the SAD and MAD studies, while the efficacy
evaluation was the primary objective of the long-term cohort.
T rial design: A multi-center, Phase II, randomized, double-blind, SAD and MAD
study, as well as a single-arm clinical study to evaluate the long-term efficacy and safety of
MT1013. The study population comprised patients with CKD-SHPT Undergoing
Maintenance Hemodialysis. The SAD study included 5 cohorts with doses of 5, 10, 20, 40,
and 60 mg. The MAD study included 3 cohorts with doses of 5, 10, and 20 mg. Each cohort
in the SAD and MAD studies included 8 subjects (6 subjects received the active
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investigational drug and 2 subjects received matching placebo) and were conducted
sequentially. All subjects in the long-term dosing cohort underwent hemodialysis 3 times
a week and were administered the drug once after each hemodialysis session for a
duration of 52 weeks. Subjects in the SAD study underwent a follow-up visit on Day 8 (±1
day), subjects in the MAD study underwent a follow-up visit within one week after the
last dose, and subjects in the long-term dosing cohort underwent follow-up for a total
period of 52 weeks.
The key inclusion criteria included: (1) male subjects aged 18 years or above and
below 80 years, and female subjects who were non-pregnant and non-lactating; (2)
patients who had received adequate hemodialysis and maintained stable treatment for
more than three months prior to screening; (3) subjects with an iPTH level of at least 300
pg/mL; and (4) subjects with serum calcium (corrected for albumin <40 g/L) of no less
than 2.25 mmol/L (9.0 mg/dL). The key exclusion criteria included but were not limited
to: (1) subjects with a history of severe ventricular arrhythmia, symptomatic ventricular
arrhythmia at screening, or QTc interval> 470 ms for males or > 480 ms for females at
screening; (2) subjects with NYHA class II or V heart failure symptoms at screening; (3)
subjects with a history of myocardial infarction, percutaneous coronary intervention or
coronary artery bypass grafting within six months prior to screening; and (4) subjects with
a history of epileptic seizures or who had received treatment for seizures.
T rial status: SAD and MAD studies: The first subject signed the informed consent
form on April 7, 2023, and the last subject completed the trial on December 17, 2023. A
total of 65 subjects were actually enrolled (64 were randomized for dosing). Long-term
dosing cohort: The first subject signed the informed consent form on February 27, 2024,
and the last subject completed the trial on May 12, 2025. A total of 33 subjects were
actually enrolled.
Pharmacokinetics results: After intravenous bolus injection of MT1013 in the 5, 10,
20, 40, and 60 mg dose groups of the single ascending dose (SAD) study, the geometric
mean C
max values of MT1013 were 434.2, 1,008.8, 1,544.9, 3,311.3, and 4,580.5 ng/mL,
respectively; the geometric mean AUC 0-t values were 362.710, 856.968, 1,529.749,
3,329.690, and 4,281.925 ng·h/mL, respectively; and the geometric mean t 1/2 values were
1.492, 1.567, 1.857, 2.062, and 2.164 h, respectively. After intravenous bolus injection of
MT1013 in the 5, 10, and 20 mg dose groups of the multiple ascending dose (MAD) study,
the geometric mean C
max values of MT1013 at the last dose were 441.5, 1,115.8, and 1,896.4
ng/mL, respectively; the geometric mean AUC 0-t values at the last dose were 373.110,
830.400, and 1,654.778 ng·h/mL, respectively; and the geometric mean t 1/2 values at the
last dose were 1.131, 1.896, and 2.175 h, respectively. Regression analysis using a power
model showed that the in vivo pharmacokinetic processes of dose and exposure in the
single-dose 5 mg to 60 mg groups and the multiple ascending dose 5 mg to 20 mg groups
exhibited linear pharmacokinetic characteristics. No significant accumulation of exposure
was observed after multiple doses.
Safety data: MT1013 demonstrated good safety and tolerability in target population
following treatment with single doses (5-60 mg) and multiple doses (5-20 mg, for 2-4
weeks). The most common (observed in >2 subjects) adverse events related to the
investigational product were blood calcium decrease associated with the
pharmacodynamic effect of MT1013 (incidence of 30.0% in the SAD study and 38.9% in the
MAD study), hypocalcemia (incidence of 16.7% in the MAD study), and QT interval
prolongation (incidence of 16.7% in the MAD study). One participant permanently
discontinued due to a TEAE of moderate hypocalcemia in the MAD 20 mg cohort, which
did not meet the criteria for severe intensity, nor SAE.
In the long-term dosing (52-week) cohort, the most common (≥10%) adverse events
related to the investigational product were blood calcium decrease associated with the
pharmacodynamic effect of MT1013 (29 cases, 87.9%) and hypocalcemia (5 cases, 15.2%).
No severe TEAEs related to MT1013, no SAEs related to MT1013, no deaths related to
MT1013, and no adverse events leading to permanent drug discontinuation occurred
during the trial. In the long-term treatment (starting dose of 5 mg or 10 mg, titrated, for 52
weeks) of patients with CKD-SHPT on hemodialysis, MT1013 demonstrated good overall
safety with manageable risks.
Efficacy data: After treatment with MT1013 in the target population, the SAD study
showed a significant decrease in serum parathyroid hormone in dose groups of 5 mg and
above compared to the placebo group, with the most significant effects observed in the 40
mg dose group (percentage change from baseline: -79.114%) and the 60 mg dose group
(percentage change from baseline: -75.950%). In the MAD study, the number (proportion)
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of patients with a >30% reduction from baseline in mean serum iPTH for the 5 mg to 20 mg
groups and the placebo group were 3 (50.0%), 4 (66.7%), 5 (100%), and 2 (33.3%),
respectively. Dose groups of 5 mg and above showed a significant decrease in serum
parathyroid hormone compared to the placebo group, with the most significant effect
observed in the 20 mg dose group. A comprehensive analysis showed that iPTH, serum
corrected calcium, and serum phosphorus decreased from baseline in all dose groups.
Furthermore, as the dose increased, iPTH and serum corrected calcium gradually
decreased, showing a clear dose-response relationship.
The trial results indicated that patients with CKD-SHPT on maintenance
hemodialysis received clinical benefits from a relatively long-term treatment of 52 weeks
with MT1013. In the long-term dosing cohort, among CKD-SHPT patients treated with
MT1013, from week 9 onwards, the mean reduction in iPTH from baseline reached 50%,
the proportion of subjects with a >30% reduction reached 80%, and the proportion with a
>50% reduction reached 60%. By week 52, these metrics were 57.2%, 93.1%, and 75.9%,
respectively. The proportion of subjects with iPTH <300 pg/mL was 65.6%, and the
proportion achieving the target range of 150-300 pg/mL was 53.1%. The study results
demonstrated that CKD-SHPT patients could generally achieve a stable
pharmacodynamic state after 9 weeks of MT1013 treatment and continued to benefit from
long-term therapy.
Week
Proportion of  iPTH Reduction
> 30%/50% (%)
0 4 8 12 16 20 24 28 32 36 40 44 48 52
0
10
20
30
40
50
60
70
80
90
100
iPTH Reduction > 30% iPTH Reduction > 50%
78.1%
62.5%
81.3%
68.8%
87.1%
71.0%
93.1%
75.9%
32.3%
12.9%
Figure: Proportion of Subjects with >30% and >50% iPTH Reduction
at Each Visit Point in MT1013-II-C01 (%)
N=33
The trial results showed that serum corrected calcium (cCa) decreased to its lowest
level at week 9 of MT1013 administration, then slowly recovered and began to stabilize,
decreasing from a relatively high calcium level to within the normal range and remaining
stable long-term, demonstrating that treatment can improve high calcium levels to the
physiological normal range with long-term stable benefits.
0 4 8 12 16 20 24 28 32 36 40 44 48 52
10.8
10.4
10.0
cCa(mg/dL)
Week
9.6
9.2
8.8
8.4
8.0
7.6
Figure: Mean Change in Serum Corrected Calcium (cCa) at Each Visit Point in
MT1013-II-C01 (mg/dL)
N=33
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The efficacy data showed that after long-term treatment with MT1013, bone
turnover markers shifted from a high-turnover state to a low-turnover state and remained
relatively stable long-term, which corroborates and aligns with the conclusion of stable
iPTH improvement after long-term MT1013 treatment. The bone mineral density
examination results further suggested potential bone benefits after a relatively long-term
treatment of 52 weeks, corroborating and aligning with the conclusion of bone marker
benefits suggested by the bone marker results.
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
5.0
Increase of BMD (%)
Lumbar Vertebra Femur Neck
4.44%
0.88%
1.65%
0.16%
W24
W52
Figure: Change in Lumbar Spine and Femoral Neck Bone Mineral Density (BMD) in
Subjects with Baseline Osteoporosis in MT1013-II-C01 (%)
N=33
6.6%
-14.5%
-27.1%**
-12.4%* -10.9%
-43.8%**
-31.1%**
-5.4%
-10.6%
-39.9%**
-32.0%**
-44.3%**
-45.6%**
-46.4%**
1.9%
b-ALP OC PINP CTX TRAP-5b
Increase of BMD (%)
W14
W24
W53
-60
-50
-40
-30
-20
-10
0
10
Figure: Change from Baseline (%) in Bone T urnover Markers in Subjects of
MT1013-II-C01
N=33, compared with baseline, *P<0.05, **P<0.01
Source: Company data
MT1013-II-C02 PRC Long-Term Dosing Study (Supportive Phase III Clinical Study)
Overview: This is a Phase IIb clinical study (supportive Phase III clinical study) of
MT1013 for injection for the treatment of patients with CKD-SHPT Undergoing
Maintenance Hemodialysis. Its primary objective was to evaluate the safety, and the
secondary objective was to evaluate the efficacy and improvement in bone mineral density
of MT1013.
T rial design: A multi-center, open-label, single-arm clinical study in a population of
patients with CKD-SHPT Undergoing Maintenance Hemodialysis. It is planned to enroll
350 subjects who undergo hemodialysis 3 times a week or 5 times every two weeks. They
will receive MT1013 at the end of each hemodialysis session for 52 consecutive weeks.
After completing the aforementioned dosing, subjects will enter an extended treatment
period to continue receiving MT1013 until the trial sponsor decides to terminate the study.
Subjects will undergo a safety follow-up assessment 7 days (±3 days) after the last dose.
A total of 350 subjects are planned to be enrolled in this trial. The key inclusion
criteria included, among others: (1) subjects who had received maintenance hemodialysis
three times per week or five times every two weeks for at least three months prior to
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screening; (2) subjects whose dialysate calcium concentration was no less than 2.5 mEq/L
(1.25 mmol/L), maintained at a stable level for at least four weeks prior to the laboratory
assessments during the screening period, and required to remain at no less than 2.5
mEq/L (1.25 mmol/L) throughout the study; (3) subjects diagnosed with CKD-SHPT and
with an iPTH level of more than 300 pg/mL at screening; for subjects who were receiving
cinacalcet, etelcalcetide, MT1013 or other calcimimetics prior to screening, the
pre-dialysis iPTH level measured during screening was required to be greater than 100
pg/mL. The key exclusion criteria included but were not limited to: (1) subjects with
primary hyperparathyroidism; (2) subjects who refused to discontinue cinacalcet,
etelcalcetide or other calcimimetics during the study; and (3) subjects who had received
denosumab or other receptor activator of nuclear factor kappa-B ligand (RANKL)
inhibitors within six months prior to screening.
T rial status: The Phase II clinical trial was initiated in March 2024. As of the Latest
Practicable Date, enrollment of all 350 subjects had been completed.
Safety data: An interim analysis of the 52-week data from the first 100 subjects in
this study showed that the most common adverse events related to the investigational
product were blood calcium decrease associated with the pharmacodynamic effect of
MT1013 (81 subjects, 234 events, 81%) and hypocalcemia (5 subjects, 5 events, 5%). There
were no cases of severe or serious hypocalcemia. In the adverse reaction, the incidences of
nausea (2 cases, 2%) and vomiting (2 cases, 2%) were low. No severe TEAEs related to
MT1013, no SAEs related to MT1013, no deaths related to MT1013, and no adverse events
leading to patient withdrawal or permanent drug discontinuation occurred during the
trial. In the long-term treatment (starting dose of 5 mg or 10 mg, titrated, for 52 weeks) of
patients with CKD-SHPT on hemodialysis, MT1013 demonstrated good overall safety
with manageable risks, and no unexpected safety signals or risks were identified.
Efficacy data: An interim analysis of the 52-week data from the first 100 subjects in
this study showed that, regardless of prior use of calcimimetics, the proportion of patients
achieving a >30% reduction in iPTH from baseline after 52 weeks of MT1013 treatment
reached 79.8%, and the proportion achieving a >50% reduction reached 64.3%. The
proportion achieving the target iPTH range of 150-300 pg/mL was 45.6%. Patients’
relatively high calcium levels were reduced to within the normal range and remained
stable long-term. In summary, the study results demonstrated that, regardless of whether
patients were previously using calcimimetics, over 80% of patients experienced further
improvement in iPTH after using MT1013, and high calcium levels were significantly
improved and maintained within the physiological normal range long-term.
iPTH Reduction Profile:
70.1%
80.7% 85.6%
79.8%
64.3%
68.9%
59.1%
48.5%
40.4%
20.2%
Week
Proportion of  iPTH Reduction
> 30%/50% (%)
0
10
0 4 8 12 16 20 24 28 32 36 40 44 48 52
20
30
40
50
60
70
80
90
100
iPTH Reduction > 30% iPTH Reduction > 50%
Figure: Proportion of Subjects with >30% and >50% iPTH Reduction
at Each Visit Point in MT1013-II-C02 (%)
N=100
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Corrected Serum Calcium Profile:
0 4 8 12 16 20 24 28 32 36 40 44 48 52
Week
10.8
10.4
10.0
cCa(mg/dL)
9.6
9.2
8.8
8.4
8.0
7.6
Figure: Mean Change in Serum Corrected Calcium (cCa) at Each Visit
Point in MT1013-II-C02 (mg/dL)
N=100
Source: Company data
MT1013-II-C03
Overview: A Phase II clinical study of MT1013 for injection for the treatment of
patients with CKD-SHPT Undergoing Maintenance Hemodialysis, with continuous
dosing for 26 weeks to evaluate the efficacy, safety, immunogenicity and pharmacokinetic
of MT1013. Efficacy evaluation was the primary objective of the study.
T rial design: A multi-center, randomized, active-controlled, and placebo-controlled
clinical study in a population of patients with CKD-SHPT Undergoing Maintenance
Hemodialysis. It is planned to enroll 112 subjects, who will be randomly assigned in a
2:2:1:1 ratio to MT1013 Group 1, MT1013 Group 2, the Etelcalcetide group, and the placebo
group. Stratified randomization will be performed based on the mean iPTH level during
the screening period (mean of two pre-dialysis measurements on different days within 14
days before randomization) of ≤800 pg/ml or >800 pg/ml. The drug was administered via
intravenous injection through the venous line of the dialysis circuit after each
hemodialysis session, three times a week, for 26 consecutive weeks. Subjects will undergo
a safety follow-up assessment within one week (+3 days) after the last dose.
A total of 114 subjects were enrolled in this trial. The key inclusion criteria included,
among others: (1) male or female subjects aged 18 years or above at the time of signing the
informed consent form; (2) subjects who had received regular maintenance hemodialysis
three times per week for at least three months prior to screening, and had undergone
adequate dialysis within four weeks prior to screening, defined as a single-pool Kt/V
(spKt/V) ≥1.2 or urea reduction ratio (URR) ≥65%; and (3) subjects diagnosed with
CKD-SHPT with dialysate calcium concentration and pre-dialysis serum iPTH level
meeting the study requirements as specified in the protocol. The key exclusion criteria
included but were not limited to: (1) subjects who had undergone parathyroidectomy
within six months prior to screening or who planned to undergo parathyroidectomy,
ablation, radiation or other related treatments during the study period; (2) subjects with a
history of gastrointestinal bleeding or peptic ulcer within six months prior to screening;
and (3) subjects with a history of myocardial infarction, percutaneous coronary
intervention or coronary artery bypass grafting within six months prior to screening.
T rial status: The Phase II clinical trial was initiated in November 2024 and
completed in March 2026.
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Safety data: In this study, MT1013 demonstrated good overall safety and
tolerability, with no unexpected safety signals or risks identified. There was no difference
in SAEs between groups, which were comparable to placebo. No severe TEAEs or SAEs
related to the investigational product were observed in the study. The incidence of
temporary drug discontinuation due to adverse reactions was higher in the Etelcalcetide
group (33.3%) than in the MT1013 groups (27.7%). No patients permanently discontinued
the drug due to adverse events. Regarding the incidence of hypocalcemia, a
pharmacodynamic effect of special concern for calcimimetics, the rate was significantly
lower for MT1013 (7.7%) compared to Etelcalcetide (12.1%), with no cases of severe or
serious hypocalcemia in either group. The MT1013 group showed a lower incidence of
gastrointestinal TRAEs compared with the Etelcalcetide group. Specifically, the
incidences of vomiting, nausea, diarrhea and abdominal discomfort were each 1.54% in
the MT1013 group, as compared with 6.06%, 3.03%, 0% and 3.03%, respectively, in the
Etelcalcetide group, suggesting that MT1013 may have a more favorable gastrointestinal
tolerability profile.
Two subjects (both in the Placebo group) withdrew from the study due to TEAEs,
including one case of weakness and one case of arthralgia.
Efficacy data: After 26 weeks of treatment in the target population, the number
(proportion) of patients with a >30% reduction from baseline in mean serum iPTH during
the EAP period for MT1013 Group 1, MT1013 Group 2 and the Etelcalcetide group was 25
(80.65%), 28 (93.33%) and 29 (90.63%), respectively. The number (proportion) of patients
with a >50% reduction was 23 (74.19%), 24 (80.0%), and 24 (75%), respectively. For patients
with severe CKD-SHPT (baseline iPTH >600 pg/mL), MT1013 showed greater
improvement in iPTH compared to Etelcalcetide: during the EAP period, the number
(proportion) of patients with a >30% reduction from baseline in mean serum iPTH was 17
(85.0%), 19 (100%), and 18 (85.71%) for MT1013 Group 1, MT1013 Group 2, and the
Etelcalcetide group, respectively. The number (proportion) of patients with a >50%
reduction was 15 (75.0%), 16 (84.21%), and 15 (71.43%), respectively. The iPTH
achievement rate (150-300 pg/mL) during the EAP period was higher for MT1013
compared to Etelcalcetide (54.8% for MT1013 Group 1, 56.7% for Group 2, and 43.8% for
the Etelcalcetide group).
During the course of treatment, the proportion of patients whose serum calcium was
controlled within the normal range was slightly better in the MT1013 groups compared to
the Etelcalcetide group (71% for MT1013 Group 1, 80% for Group 2, and 68.8% for the
Etelcalcetide group). In terms of serum phosphorus control, MT1013 was more effective
than Etelcalcetide in lowering serum phosphorus (percentage reduction in serum
phosphorus from baseline at Week 27: 11.2% for MT1013 Group 1, 11.6% for Group 2, and
5.3% for the Etelcalcetide group). In terms of achieving the composite endpoint for all
three indicators (iPTH: 2-9 times the upper limit of normal (130-586 pg/mL); serum
calcium: 2.10-2.50 mmol/L; serum phosphorus: 1.13-1.78 mmol/L), MT1013 was also
more effective than Etelcalcetide (34.48%-39.29% for MT1013 groups vs. 15.63% for
Etelcalcetide). The composite endpoint achievement rates for the two MT1013 dose groups
were 220%-251% of that of Etelcalcetide.
-30
-20
-25
-15
-10
-5
0
15
Proportion for P Reduction
(%) -5.3%
-11.6%
MT1013-G1 MT1013-G2 Etelcalcetide
-11.2%
Placebo
0.081%
Higher than Etelcalcetide 211-222%
Figure: Reduction Rate (%) of Serum P from Baseline in Each Group at W27
Treatment groups at W27 N=28-32/group, placebo group N=9
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1.0
1.4
1.8
2.2
2.6
3.0
2.07
W27
Baseline
MT1013-G1 MT1013-G2 Etelcalcetide Placebo
1.79
P (mmol/L)
2.00
1.70
1.86
1.73
2.04
1.92
P=0.014
P=0.013
P=0.252
P=0.512
Figure: Change in Serum P (mmol/L) in Each Group Before and After T reatment
(Mean±SEM)
Note: treatment groups/28-32 subjects, placebo group/9 subjects
Source: Company data
The efficacy data showed that MT1013 demonstrated larger reductions compared
with Etelcalcetide in terms of absolute reduction in FGF-23 and a higher proportion of
subjects with a> 30% reduction in FGF-23. This trend is consistent with the trend of
composite achievement rate of iPTH/serum calcium/serum phosphorus over
Etelcalcetide. Showing that MT1013 has the potential to reduce the incidence of
cardiovascular events and the risk of death.
P=0.012-60
-50
-40
-30
-20
-10
0
10
Proportion for FGF23 Reduction
(%)
-22.8%
-8.8%
-39.9%
MT1013-G1 MT1013-G2 Etelcalcetide Placebo
-33.5%
Figure: Reduction Rate (%) of FGF23 from Baseline in Each Group at W27
(Mean±SEM)
Notes: Treatment groups at W27 N=27-30/group, placebo group N=8
Proportion of FGF23 Reduction
> 30% (%)
10
20
30
40
50
60
70
80
MT1013-G1 MT1013-G2 Etelcalcetide Placebo
)JHIFSUIBO&UFMDBMDFUJEFCZ117%~133%
58.6%
66.7%
50.0%
25.0%
Figure: Proportion of Subjects (%) with> 30% Reduction in FGF-23 from Baseline in
Each Group at W27
Note: W27: treatment groups N=27-30 per group; placebo group N=8
Source: Company Data
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0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
5,000
2,667.3
1,675.0
3,722.2
1,840.5
3,318.8
2,235.4 2,236.9
3,318.8
MT1013-G1 MT1013-G2 Etelcalcetide Placebo
FGF23 (pg/mL)
Baseline
W27
P=0.013
P=0.003
P=0.211 P=0.242
*P=0.046
Figure: Change in FGF23 (pg/mL) in Each Group Before and After T reatment
(Mean±SEM)
Treatment groups at W27 N=27-30/group, placebo group N=7. *P=0.046: For the log value of change from baseline at
W27, MT1013 was more effective than etelcalcetide
Source: Company data
MT1013-III-C01
Overview: This is a Phase III clinical study of MT1013 for injection for the treatment
of patients with CKD-SHPT Undergoing Maintenance Hemodialysis, aiming to evaluate
the safety and efficacy of MT1013. The primary endpoint 1 was the proportion of subjects
achieving a reduction of >50% in serum iPTH from baseline during the EAP with MT1013
compared to Cinacalcet. The primary endpoint 2 was the proportion of subjects achieving
a reduction of> 30% in serum iPTH from baseline during the EAP with MT1013 compared
to Cinacalcet.
T rial design: A multi-center, randomized, double-blind, double-dummy clinical
study with cinacalcet as the active comparator. The study population comprises subjects
with CKD-SHPT Undergoing Maintenance Hemodialysis. It is planned to enroll 424
subjects, randomized 1:1 into the MT1013 group and the cinacalcet group, to receive either
MT1013 + cinacalcet placebo or cinacalcet + MT1013 placebo, respectively.
MT1013/MT1013 placebo: Subjects undergo regular hemodialysis three times a week.
After each dialysis session, MT1013 is administered directly through the venous line of the
dialysis circuit or intravenously after the full flush is complete, for 26 consecutive weeks.
Cinacalcet/cinacalcet placebo: Except for the post-dialysis dose on D1, subjects take
cinacalcet orally with or after a meal once a day (QD). It is recommended to take the
medication at the same time each day, ensuring an interval of ≥12 hours before iPTH blood
sampling, for 26 consecutive weeks. Subjects will enter a 4-week safety follow-up period
after the last dose.
A total of 424 subjects are planned to be enrolled in this trial. The key inclusion
criteria included, among others: (1) subjects who fully understood and voluntarily agreed
to participate in the study and signed the informed consent form; (2) male or female
subjects aged 18 years or above at the time of signing the informed consent form, with BMI
between 18 kg/m² and 35 kg/m², calculated based on post-dialysis body weight; (3)
subjects who had been receiving regular maintenance hemodialysis three times per week
for at least 12 weeks prior to screening, and had undergone adequate dialysis within four
weeks prior to screening, defined as a urea clearance index (Kt/V) ≥1.2 or urea reduction
ratio (URR) ≥65%, with each dialysis session lasting 3 to 4.5 hours (inclusive). The key
exclusion criteria included but were not limited to: (1) subjects who had undergone
parathyroidectomy within six months prior to screening or who planned to undergo
parathyroidectomy, ablation, radiation or other related treatments during the study
period; (2) subjects with a history of gastrointestinal bleeding or peptic ulcer within six
months prior to screening; (3) subjects with a history of myocardial infarction,
percutaneous coronary intervention or coronary artery bypass grafting within six months
prior to screening.
T rial status: The Phase III clinical trial was initiated in July 2025 and as of the Latest
Practicable Date, enrollment of all 424 planned subjects had been completed.
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Clinical Development Plan
In May 2025, MT1013 completed the Phase II-C01 clinical study for CKD-SHPT in
the PRC and has entered a Phase III clinical study with cinacalcet as a comparator. It is the
only dual-functional polypeptide drug to have completed Phase II clinical studies. The
ongoing Phase III clinical trial, in addition to evaluating the primary efficacy endpoints,
also places special focus on changes in bone metabolism-related parameters. We plan to
seek marketing approval for MT1013 with the treatment of CKD-SHPT Undergoing
Maintenance Hemodialysis. We expect to submit a Pre-NDA in late 2026, and an NDA in
early 2027.
Concurrently, we are actively expanding the indications for our Core Product
MT1013 into areas such as CKD-MBD with Osteoporosis and CKD-SHPT not on Dialysis.
MT1013 not only demonstrates performance in controlling mineral levels such as iPTH,
serum calcium, and serum phosphorus, but the results of the phase-II clinical trial also
show a positive effect on improving bone mineral density, particularly significant in
high-risk patients with osteopenia. For more information of the clinical results, see
“Business — Clinical Trial Overview of MT1013”. This clinical benefit not only validates
the potential clinical value of MT1013 in the treatment of bone diseases related to mineral
metabolism disorders but also lays the foundation for its development for broader
indications within CKD-MBD. We plan to leverage data collected from the phase II clinical
trials to seek IND approvals from competent regulatory authorities to conduct Phase III
clinical trial of MT1013 for the expanded indication of CKD-MBD with Osteoporosis.
The table below sets out our clinical development plan:
Indication Current Status/T rial Phase Location Upcoming Milestones
CKD-SHPT .... MT1013-I-C03 PRC Phase I Mass Balance Study PRC Expected to complete by mid-2026
MT1013-II-C02 PRC Phase IIb Long-Term Dosing
Study (Supportive Phase III Clinical Study)
PRC Expected to complete by end of 2026
MT1013-III-C01 Confirmatory Phase III Study
with Cinacalcet as Active Comparator
PRC Expected to complete by the end of 2026; Expected
to submit Pre-NDA in late 2026, and NDA in
early 2027.
CKD-SHPT .... I N D r eactivated (1) U.S. Potential advancement of Phase II clinical
development in the U.S., subject to identification
of suitable collaboration partner(s)
CKD-MBD with
Osteoporosis . .
IND in preparation PRC Expected to commence Phase III clinical trial in
early 2028
CKD-SHPT not on
Dialysis
(2) ....
IND in preparation PRC Expected to file IND by the end of 2027
Notes:
(1) Following completion of the MT1013-I-A01 U.S. Phase I trial, our Group faced financing
constraints amid a downturn in the global biopharmaceutical financing environment. As a result,
we prioritized resources on development activities in the PRC and suspended the U.S.
development program, which was not due to any safety or efficacy concerns relating to MT1013.
Consequently, the IND application for MT1013 in dialysis CKD-SHPT patients in the U.S. was
placed on inactive status in October 2023. Following improvements in the overall financing
environment and receipt of proceeds from our Group’s Series D financing in 2025, we reactivated
the IND for MT1013 in the U.S. primarily to facilitate the submission of an application for
Breakthrough Therapy Designation to the FDA and to maintain the possibility of potential future
development and collaboration opportunities in the U.S.. The IND was reactivated on February
13, 2026, and approval from the FDA was obtained on March 20, 2026 to proceed to a Phase II
clinical trial. In addition, we submitted an application to the FDA for Breakthrough Therapy
Designation on April 10, 2026. As of the Latest Practicable Date, we had not identified any
suitable collaboration partner and had not commenced any new clinical trials in the U.S..
(2) We plan to further advance the clinical development of MT1013 for the treatment of CKD-SHPT in
patients not on dialysis and to develop an oral formulation for such indication, as oral
administration is more suitable for non-dialysis CKD-SHPT patients and may improve
compliance. We will rely on clinical data generated from existing clinical trials of MT1013 in
CKD-SHPT patients to further progress the clinical development of MT1013 for non-dialysis
CKD-SHPT patients, including data relating to the relationship between drug exposure and
efficacy, as well as safety profiles.
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Material Communications
As of the Latest Practicable Date, we had not received any objection from any relevant regulatory authorities to our clinical
development plans.
The table below sets out our key regulatory communications with regulatory authorities regarding the development of MT1013 for
the treatment of CKD-SHPT:
Study Study number Phase
Competent
authorities Study sites Details of communications Status
CKD-SHPT . . MT1013-I-A01 I FDA US (i) In January 2021, we filed IND application with the FDA for MT1013 for the treatment of CKD-SHPT. The
FDA subsequently initiated the technical review of the IND submission and did not raise any further
comments on the clinical trial protocol during the review process.
Completed: we achieved
each objective set out
in the clinical trial
overview on June 21,
2022.(ii) In March 2021, the FDA issued Study May Proceed Letter to allow us to proceed the Phase I clinical study
to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of MT1013 in
healthy subjects.
MT1013-I-C02 I NMPA PRC (i) In April 2021, we filed an IND application with the NMPA for the clinical development of MT1013 for the
treatment of CKD-SHPT, and the NMPA accepted our IND application in the same month.
Completed: we achieved
each objective set out
in the clinical trial
overview on
September 24, 2022.
(ii) In July 2021, the NMPA issued an umbrella IND approval
(1) for Phase I, Phase II and Phase III clinical
studies of MT1013 for the treatment of CKD-SHPT, and required us to (1) revise the Phase I clinical trial
protocol under this application with particular attention to the starting dose, which was recommended to
be set with at least a tenfold safety margin; (2) closely monitor the potential risks of the product and
strictly implement the risk management plan; (3) closely track the development progress of drugs with
similar targets and, based on the existing non-clinical and clinical data of the product, evaluate its efficacy
and safety profile and ensure adequate risk control and subject protection; and (4) apply for a
communication meeting with the CDE upon the completion of Phases I and II clinical trials before
commencing the Phase III clinical trial.
MT1013-I-C03
(2) I NMPA PRC (i) In March 2025, we submitted a communication meeting application to the CDE for the mass balance study
of MT1013.
Ongoing (all subjects
completed the trial as
of the Latest
Practicable Date) and
is expected to be
completed by
mid-2026.
(ii) In August 2025, we reached a consensus with the CDE on the clinical trial protocol of the mass balance
study.
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Study Study number Phase
Competent
authorities Study sites Details of communications Status
MT1013-II-C01 II NMPA PRC (i) In September 2022, the initial clinical study report (CSR) of MT1013-I-C02 was issued, marking the
completion of the Phase I clinical trial. In October 2022, we submitted an application to the CDE for an
end-of-Phase I (EOP1) communication meeting to seek guidance on the initiation of the Phase II clinical
trial of MT1013.
Completed: we achieved
each objective set out
in the clinical trial
overview for the SAD
and MAD studies on
April 8, 2025, and for
the long-term cohort
on August 25, 2025.
(ii) In January 2023, based on the results of our Phase I clinical study (MT1013-I-C02), the CDE, in its written
feedback, had no objection for the Company to proceed with the Phase II clinical study to further evaluate
the efficacy and safety of MT1013 in patients with CKD-SHPT, with a view to providing a basis for
determining the dosing regimen and dosage for the confirmatory Phase III clinical study.
MT1013-II-C02 IIb
(3) NMPA PRC Ongoing (4) (enrollment
of all 350 subjects
completed as of the
Latest Practicable
Date) and is expected
to be completed by
the end of 2026.
MT1013-II-C03 II NMPA PRC (i) In February 2024, upon completion of the single-ascending-dose and multiple-ascending-dose Phase II
clinical studies (the first part of MT1013-II-C01), we submitted the first end-of-Phase II (EOP2)
communication meeting application to the CDE to seek guidance on the initiation of the Phase III clinical
trial of MT1013.
Completed: we achieved
each objective set out
in the clinical trial
overview in March
2026.
(ii) In July 2024, based on the results of the existing Phase II clinical studies, the CDE recommended
conducting a small-scale comparative study of MT1013 in comparison with Etelcalcetide and placebo to
further justify the rationale of the starting dose, titration scheme and dose adjustment, and to provide
supportive data for the subsequent confirmatory Phase III clinical study.
(iii) In July 2024, we commenced preparatory work for the MT1013-II-C03 study based on the recommendation
of the CDE.
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Study Study number Phase
Competent
authorities Study sites Details of communications Status
MT1013-III-C01 III NMPA PRC (i) In May 2025, upon completion of the Phase II clinical study (MT1013-II-C01) and obtaining part of the key
data from the MT1013-II-C02 and MT1013-II-C03 studies, we submitted another end-of-Phase II (EOP2)
communication meeting application to the CDE to seek guidance on the initiation of the Phase III clinical
trial of MT1013.
Ongoing and is
expected to be
completed by the end
of 2026.
(ii) In June 2025, based on the Phase II data submitted, including (a) the completed results of MT1013-II-C01,
(b) available data from MT1013-II-C02, and (c) data from the head-to-head study MT1013-II-C03, for which
22-week data had been obtained, which demonstrated efficacy comparable to the marketed calcimimetics,
the CDE confirmed that MT1013 demonstrated efficacy comparable with marketed drug product and
agreed that we could proceed to the Phase III clinical trial. The CDE did not impose any additional
requirements in respect of the Phase II clinical trials or required any additional communication before the
commencement of the Phase III clinical trial. Further, a consensus was reached with the CDE that, if the
Phase III clinical trial of MT1013 achieves the expected results, the subject exposure level would be
sufficient to support the subsequent NDA submission and approval.
Notes:
(1) In July 2021, the NMPA issued an umbrella IND approval for the clinical development of MT1013 for the treatment of CKD-SHPT, covering Phase I, Phase II
and Phase III clinical trials. According to the Announcement on Several Policies on Drug Registration Review and Approval (ഄ
ʮѓ) issued by the NMPA, the INDs of new drugs are subject to one-time approvals instead of phased declarations, reviews and approvals. Pursuant to
such IND approval, we are required to communicate with the CDE after completion of the Phase I and Phase II clinical trials and prior to commencement of
the Phase III clinical trial.
The IND approval issued by the NMPA in July 2021 does not cover endpoints including mass balance, long-term safety and patient exposure. Therefore,
MT1013-I-C03 and MT1013-II-C02 (the “ Ongoing T rials ”) were initiated voluntarily by our Company and not requested or mandated by the NMPA or any
other regulatory authority in light of results of earlier trials or as a condition for further development of MT1013 (i.e. Phase III). As the NMPA issued an
umbrella IND approval for the clinical development of MT1013 for the treatment of CKD-SHPT in July 2021, the Ongoing Trials do not require additional IND
approval. The Ongoing Trials are supportive in nature and will be submitted as part of the NDA package to supplement the overall clinical data package, and
do not constitute one of the phases of clinical trial for advancing MT1013 to the next phase of clinical trial.
(2) The ongoing Phase I clinical trial (MT1013-I-C03) is a mass balance study designed to quantitatively analyze the total radioactivity, radioactive metabolite
profiles, pharmacokinetic parameters and safety following intravenous administration of [
14C] MT1013. This mass balance study is not intended to evaluate
clinical efficacy or to determine the optimal therapeutic dose. Instead, it focuses on the disposition of the drug in the human body, based on the principle of
mass conservation, to understand the fate of the drug and its metabolites following administration. The results from this study are intended to support the
overall clinical development of MT1013 by providing a comprehensive understanding of its pharmacokinetic and metabolic characteristics in humans, rather
than to inform efficacy or dose selection decisions. As confirmed by Frost & Sullivan, such mass balance study is an ADME (absorption, distribution,
metabolism and excretion)-related clinical pharmacology supporting study. It will not alter the established study design for the Phase I/II clinical trials, nor
will it delay or preclude the initiation of Phase III clinical trials.
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(3) The MT1013-II-C02 trial is a long-term dosing study, the primary objective of which is to evaluate safety. According to Frost & Sullivan, Phase II clinical trials
are generally designed to generate preliminary efficacy data to inform key development decisions, including progression into Phase III clinical trials.
However, MT1013-II-C02 was not designed to establish confirmatory efficacy or to serve as a principal basis for such progression. Instead, its primary role is
to provide additional safety data and patient exposure information in accordance with ICH E1 guidance on the extent of population exposure to assess clinical
safety for drugs intended for long-term treatment of non-life-threatening conditions. MT1013-II-C02 does not form part of the basis for progression to
MT1013-III-C01 as the safety and efficacy profile necessary for advancement into the Phase III clinical trial had already been established by MT1013-I-C02,
MT1013-II-C01 and MT1013-II-C03. As further confirmed during the EOP2 communication meeting with the CDE in June 2025, based on the Phase II clinical
data already obtained, MT1013 demonstrated efficacy comparable with marketed drug product, and the CDE agreed that we could proceed to the Phase III
clinical trial. In the event that such study is not completed as scheduled or the study results are not satisfactory, it would not affect the validity of the existing
Phase III clinical trial data.
(4) The MT1013-II-C02 trial was initiated in March 2024 and enrollment of all 350 subjects was completed as of the Latest Practicable Date. The relatively
extended enrollment period was mainly due to the increase in the planned sample size to approximately 350 subjects following the feedback from the CDE
during the EOP2 communication, and we expanded the study to achieve the required patient exposure level. Although CKD-SHPT falls within the scope of
ICH E1 for chronic non-life-threatening conditions, the CDE has not issued specific guidance on patient exposure requirements for CKD-SHPT. Accordingly,
we voluntarily communicated with the CDE in relation to MT1013-II-C02 in order to align with the CDE on the adequacy of long-term patient exposure and
safety data for CKD-SHPT and to facilitate the effective continued conduct of MT1013-II-C02. It does not constitute a reassessment of the safety of the Core
Product as a result of any safety concern identified in earlier clinical trials. Rather, safety evaluation is a continuous process throughout the clinical
development of innovative drug candidates and continues to evolve with the accumulation of long-term dosing data and increased patient exposure. In
particular, given that CKD-SHPT is a chronic disease requiring long-term treatment, continuous safety monitoring and accumulation of patient exposure data
are routine components of the clinical development process for relevant therapeutic agents. According to Frost & Sullivan, our conduct of continuous safety
evaluation throughout the clinical development process (not limited to early-stage clinical trials), is consistent with the general clinical development practice
for therapeutic agents intended for chronic diseases.
BUSINESS
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Based on the completion of the Phase I clinical trial (MT1013-I-C02) for the
treatment of CKD-SHPT in the PRC, and CDE having no objection for the Company to
proceed into Phase II clinical trials, the Company’s clinical development demonstrates
that for CKD-SHPT, MT1013 has been developed beyond concept stage and is eligible as
Core Product.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET MT1013
SUCCESSFULLY
Our Key Product — XTL6001
Our Key Product, XTL6001, is a GLP-1R/GCGR/MasR triple-agonist that has
received IND approval in both the PRC and the US and has entered the clinical trial stage,
with potential applications in the treatment of diseases such as obesity, chronic kidney
disease (CKD) with proteinuria, and MASH. Through its mechanism of action, XTL6001 is
expected to address issues associated with current GLP-1 weight-loss drugs, such as
muscle loss, appetite suppression or GI side effect, and rebound after drug withdrawal,
offering a new multi-organ protective therapeutic option for metabolic diseases.
Mechanism of Action
XTL6001 is a recombinant tri-target peptide-Fc fusion protein that activates GLP-1R,
GCGR and MasR to exert pharmacological effects.
Brain
XTL6001:
GLP1R/GCGR/
MasR tri-target
agonist
GLP1R/GCGR
activated
BAT
Liver
Pancreas
Appetite
Food intake
Body weight
Glycemic control
Blood glucose
Insulin sensitivity
Cholesterol
Hepatosteatosis
Energy expenditure
MasR activated
Induces vasodilation
Vasodilation
Blood Pressure
Renal Circulation
Water and Sodium Retention
Fibrosis
Liver Inflammation
Oxidative Stress
Ameliorates lipid
metabolism disorder
Reduces
microcapillary damage
• Effect of XTL6001 on Chronic Weight Management in Obese or Overweight Populations
GLP-1R activation can slow down gastric emptying, and increase satiety signals to
reduce food intake; Upon activation, GCGR acts on the liver to inhibit insulin secretion
and stimulate hepatic gluconeogenesis and glycogenolysis, promoting fatty acid
oxidation, regulating purine metabolism, and stimulating lipid catabolism and metabolic
processes to reduce body fat. The energy expenditure effect from GCGR activation and the
food intake reduction effect from GLP-1 receptor activation can synergistically reduce
body weight. Activation of MasR also promotes brown adipose tissue mass, improves
thermogenesis, reduces lipid droplets, promotes lipolysis, reduces inflammation,
improves overall thermogenesis, and increases muscle mass. Upon activation, renal MasR
leads to vasodilation, lowers blood pressure, improves renal circulation, reduces water
and sodium retention, ameliorates liver and kidney inflammation, reduces fibrosis, and
alleviates oxidative stress.
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Therefore, the GLP-1R, GCGR, and MasR triple-agonist XTL6001, through
multi-target synergy promotes lipolysis, increases muscle mass (fat reduction and muscle
gain), thereby potentially achieving sustained weight loss.
Source:
(1) Proença AB, et al. Adipose tissue plasticity mediated by the counterregulatory axis of the
renin-angiotensin system: Role of Mas and MrgD receptors. J Cell Physiol. 2024 Jun;239(6):e31265
(2) Gironacci MM, et al. Unraveling the crosstalk between renin-angiotensin system receptors. Acta
Physiol (Oxf). 2024 May;240(5):e14134
(3) Passos-Silva DG, Verano-Braga T, Santos RA. Angiotensin-(1-7): beyond the cardio-renal actions.
Clin Sci (Lond). 2013 Apr;124(7):443-56. doi: 10.1042/CS20120461. PMID: 23249272
• Effect of XTL6001 on Proteinuric CKD
XTL6001 exerts synergistic effects after multi-target activation. It can
simultaneously regulate glomerular hemodynamics and protect mechanically sensitive
podocytes, directly targeting the pathophysiological mechanisms of CKD onset and
progression to protect renal function. It directly improves hemodynamics by activating
MasR and GLP-1R, reducing glomerular capillary pressure and protecting the filtration
barrier; It exerts stronger anti-inflammatory and anti-fibrotic effects by activating MasR
and GLP-1R, reducing glomerular and tubulointerstitial damage; Activation of MasR can
combat oxidative stress, directly protect podocytes, inhibit podocyte apoptosis and
nephrin loss, and repair the filtration barrier; In addition, GCGR/GLP-1R/MasR
activation can reduce weight and improve insulin resistance, inhibit uric acid synthesis,
and promote uric acid excretion, thereby ameliorating the hyperuricemia common in CKD
patients and further protecting renal function by mitigating kidney damage caused by
high uric acid; Other indirect effects stem from its potential beneficial effects on blood
glucose, lipids, and blood pressure.
Source:
(1) Kanbay M, Copur S, Bakir CN, Covic A, Ortiz A, Tuttle KR. Glomerular hyperfiltration as a
therapeutic target for CKD. Nephrol Dial Transplant. 2024 Jul 31;39(8):1228-1238
(2) Simões E Silva AC, Teixeira MM. ACE inhibition, ACE2 and angiotensin-(1-7) axis in kidney and
cardiac inflammation and fibrosis. Pharmacol Res. 2016 May;107:154-162
• Effect of XTL6001 on MASH
XTL 6001 combines the extrahepatic benefits of GLP-1 receptor agonism (glycemic
control, appetite reduction, and weight loss) with the direct hepatic effects of glucagon
receptor agonism (increased energy expenditure, lipolysis, and hepatic fat mobilization),
creating a powerful synergy of complementary advantages. Activation of Ang1-7/MasR
can activate AMP-activated protein kinase (AMPK), inhibit HSC activation, and accelerate
HSC apoptosis, thereby inhibiting and blocking the pathogenesis and progression of liver
fibrosis. Therefore, the GLP-1R, GCGR, and MasR triple-agonist XTL6001, through
synergistic effects, is expected to comprehensively improve MASH and block its
progression.
Source:
(1) Spezani R, Mandarim-de-Lacerda CA.The current significance and prospects for the use of dual
receptor agonism GLP-1/glucagon. Life Sci 2022;288:120188
(2) Valdecantos MP , Pardo V , Ruiz L, Castro-Sánchez L, Lanzón B, Fernández-Millán E,
García-Monzón C, Arroba AI, González-Rodríguez Á, Escrivá F, Álvarez C, Rupérez FJ, Barbas C,
Konkar A, Naylor J, Hornigold D, Santos AD, Bednarek M, Grimsby J, Rondinone CM, Valverde
ÁM. A novel glucagon-like peptide 1/glucagon receptor dual agonist improves steatohepatitis
and liver regeneration in mice. Hepatology. 2017 Mar;65(3):950-968
BUSINESS
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--- page 181 ---
Market Opportunities and Competition
Overweight and Obesity
Overweight and obesity are chronic diseases characterized by excessive fat
accumulation that poses risks to health. These conditions are the major contributors to
various other health issues, such as diabetes and cardiovascular diseases. The global
prevalence of overweight and obesity patients is projected to reach 3,070.6 million by 2030
and 3,477.2 million by 2035, while in the PRC it is projected to reach 756.5 million by 2030
and 860.5 million by 2035. As of the Latest Practicable Date, there are 17 triple-target
GLP-1R peptide drug candidates for overweight and obesity in the clinical stage globally.
Among these, 12 drug candidates target GLP-1R,GCGR and GIPR, two drug candidates
target GLP-1R,GCGR and FGF21, one drug candidate targets GLP1R, GIPR, and AMYR, and
one drug candidate targets GLP1R, GIPR, and NPY2R. XTL6001, our GLP-1R drug candidate,
is the only triple-target GLP-1R peptide drug candidate targeting GLP-1R, GCGR and MasR.
Agonizing MasR can increase protein synthesis and preserve muscle mass. XTL6001 holds
the potential to eliminate the side effect of muscle loss associated with GLP-1R agonists
during weight loss. For more information, see “Industry Overview — Main treatment of
Overweight and Obesity” and “Industry Overview — Competitive landscape of GLP1R
polypeptide drugs.”
Proteinuric CKD
In the PRC, the prevalence of CKD with proteinuria grew from 76.0 million in 2020
to 81.9 million in 2025 at a CAGR of 1.5% and is projected to reach 87.5 million by 2030 and
92.9 million by 2035. For more information on the treatment of Proteinuric CKD, see
“Industry Overview — Overview of CKD with Proteinuria.”
MASH
In the PRC, the prevalence of MASH grew from 38.7 million in 2020 to 45.5 million in
2025 at a CAGR of 3.3% and is projected to reach 53.7 million by 2030 and 63.1 million by
2035. For more information on the treatment of MASH, see “Industry Overview —
Overview of MASH.”
Competitive Advantages
Chronic Weight Management in Obese or Overweight Populations
(1) Focus on a weight-loss mechanism through enhanced energy metabolism
XTL6001 achieves weight loss primarily by increasing energy expenditure rather
than by strongly suppressing appetite. Compared to other GLP-1 class drugs that
primarily rely on delaying gastric emptying, XTL6001 has the potential to significantly
reduce gastrointestinal adverse reactions while achieving weight loss.
Preclinical studies have shown that XTL6001 can progressively, dose-dependently,
and significantly reduce the body weight of diet-induced obesity (DIO) mice without
significantly affecting food intake, attributable to its mechanism of promoting energy
expenditure to achieve weight control, which may improve tolerability and treatment
adherence while achieving weight reduction.
BUSINESS
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--- page 182 ---
Time (Days)
rate of change (vs.Baseline)
0
-20
-40
-60
20
Vehicle
Tirzepatide 0.13μmol/kg
XTL6001 0.07μmol/kg
XTL6001 0.13μmol/kg
XTL6001 0.26μmol/kg
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
5.68%
-14.22%
-25.04%
-32.64%
-39.95%
Food intake (g/d)
Time (Day)
0
3
2
1
0
3 7 10 14 17 21 24 28
Vehicle
Tirzepatide 0.13μmol/kg
XTL6001 0.07μmol/kg
XTL6001 0.13μmol/kg
XTL6001 0.26μmol/kg
Effects of XTL6001 vs. Tirzepatide on body weight and food intake
in a DIO mouse model (n=12)
Source: Company data
(2) Precise fat reduction and effective prevention of muscle loss
The preclinical study has shown that XTL6001 dose-dependently reduces body
weight and total fat mass, increases total lean body mass, and raises the total lean
mass/fat mass ratio to normal levels in DIO mice.
60
50
40
30
20
40
30
20
10
0
100
80
60
40
15
10
5
0
***
###
-24.0%
20.63%
###
###
***
###
### ###
######
###
***
###
#####
***
-33.0% -40.6%
32.63%
Body weight (g)proportion of lean (%)
Lean/Fat Ratio proportion of fat (%)
Control Vehicle 0.07 0.13
XTL6001
0.26
μmol/kg
Control Vehicle 0.07 0.13
XTL6001
0.26
μmol/kg
Control Vehicle 0.07 0.13
XTL6001
0.26
μmol/kg
Control Vehicle 0.07 0.13
XTL6001
0.26
μmol/kg
24.50%
-44.08%
-55.44% -58.15%
Effect of XTL6001 on total lean body mass and fat mass (MRI) (n=10)
***P<0.001 vs. Control; ##P<0.01; ###P<0.001 vs. Vehicle
Source: Company data
Phase I clinical trial results further suggest that XTL6001 may reduce waist
circumference and waist-to-hip ratio (WHR), with effects observed to persist following
treatment discontinuation. For more information, see “— Clinical Trial Overview of
XTL6001” below in this section.
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--- page 183 ---
(3) Significantly lowers blood lipids, hepatic lipids, and uric acid; reverses fatty liver;
reduces proteinuria; and addresses obesity-related organ damage
Preclinical studies have shown that compared to Tirzepatide, XTL6001 shows a
greater reduction in reversing fatty liver (reducing hepatic fat by over 93.95%) (Figure 1).
In comparison with Finerenone, XTL6001 reduced urinary albumin-to-creatinine ratio
(UACR) by an additional 15% to 50% (Figure 2).
##
***
&P<0.05
-78.74%
0.13
Tirzepatide
Control Vehicle
XTL6001
0.07 0.13 0.26
-53.54%
-85.36% -93.95%
μmol/kg
## ##
0
1
2
3
4
5
6
Hepatic fat (%)
 Control Vehicle Tirzepatide 0.13 μmol/kg
XTL6001 0.07 μmol/kg XTL6001 0.13 μmol/kg XTL6001 0.26 μmol/kg
Figure 1: Effect of XTL6001 on hepatic fat in DIO obese mice (vs. Tirzepatide, n=12)
400
500
600
300
200
100
0
U-ALB mg/24h
***
4W
###
-38.64%
***
###
-64.49% ###
-55.85%
###
-58.34%
###
-81.65%
Control
Vehicle
Fine 1.6mg/kg
XTL6001-0.06mg/kg
XTL6001-0.17mg/kg
XTL6001-0.5mg/kg
XTL6001-4.5mg/kgVehicle
Fine 1.6mg/kg
XTL6001-0.06mg/kgXTL6001-0.17mg/kgXTL6001-0.5mg/kgXTL6001-4.5mg/kg
Control
40
50
60
30
20
10
0
UACR mg/g
**
4W
-28.94%
-44.86%
-48.23%
-55.47%
-80.06%
Control
Vehicle
Fine 1.6mg/kg
XTL6001-0.06mg/kg
XTL6001-0.17mg/kg
XTL6001-0.5mg/kg
XTL6001-4.5mg/kgVehicle
Fine 1.6mg/kg
XTL6001-0.06mg/kgXTL6001-0.17mg/kgXTL6001-0.5mg/kgXTL6001-4.5mg/kg
Control
#
*** P<0.001 vs. control; #P<0.05e##P<0.01e###P<0.001vs. Vehicle
Figure 2: In a rat model of diabetic nephropathy with proteinuria induced by
alloxan combined with unilateral nephrectomy, the reduction rate of UACR by
XTL6001 was 15% to 50% higher than that of finerenone.
(n=12)
Source: Company data
Phase I clinical trial results further suggest that XTL6001 may improve lipid profiles
and reduce serum uric acid levels, with increases in uric acid clearance observed. For more
information, see “— Clinical Trial Overview of XTL6001” below in this section.
(4) Favorable safety and potential for long-acting administration
Phase I study results showed that XTL6001 exposure increases with dose escalation,
and once-weekly dosing maintained effective plasma drug concentrations for over one
week. Safety data showed that XTL6001 has a good overall safety profile, with no serious
adverse events (SAEs) occurring. Apart from the expected pharmacodynamically-related
gastrointestinal adverse reactions (which were transient and dose-dependent) associated
with GLP-1 class drugs at high doses, no other significant safety signals were observed.
For more information of the clinical results, see “— Clinical Trial Overview of XTL6001”
below in this section.
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Clinical Trial Overview of XTL6001
XTL6001-I-C01 PRC Phase I Clinical Study
Overview: This is a randomized, double-blind, placebo-controlled Phase I clinical
trial involving single ascending dose (SAD) and multiple ascending dose (MAD) in
healthy and obese subjects. Its primary objective was to evaluate the safety and
tolerability, and the secondary objective was to characterize the pharmacokinetics,
pharmacodynamics and immunogenicity of XTL6001, to inform optimal dose selection
and dosing regimen for Phase II studies. The trial covers both indications of weight
management for obesity and Proteinuric CKD.
T rial design:
A randomized, double-blind, SAD and MAD Phase I clinical study in healthy volunteers
SAD MAD
SRC
SRC
• Randomization:  XTL6001:placebo=3:1
• Primary Endpoint: Safety, PK,PD
D1 D8 D15 D22 D29
Group 1
Group 2
N=10
N=15
• Randomization:  XTL6001:placebo=4:1,QW
• Primary Endpoint: Safety, PK,PD
D: day
37.5 mg
75mg
150mg
300 mg
SRC
N=8
N=8
N=8
N=8
75mg 300mg150 mg 225mg
75mg 75mg 150 mg 150 mg 225 mg
•M ultiple Ascending Dose (MAD) evaluates the safety and accumulation
effects of continuous administration
• The dosing regimen design covers the step-wise escalation from the starting
dose to the expected maximum clinical dose
A total of 57 subjects are planned to be enrolled in this trial. The key inclusion
criteria included: (1) subjects aged 18 years or above and below 65 years at the time of
screening; (2) subjects with BMI of no less than 18.5 kg/m² and below 40.0 kg/m²; and (3)
subjects with a body weight of no less than 50.0 kg for males and no less than 45.0 kg for
females at screening. The key exclusion criteria included but were not limited to: (1)
subjects with a history of type I or type II diabetes mellitus, or with glycated hemoglobin
(HbA1c)> 6.5% or fasting plasma glucose> 7.0 mmol/L at screening; (2) subjects who had
used prescription or over-the-counter (OTC) medications known to cause weight loss
within three months prior to screening; (3) subjects with known clinically significant
gastric emptying disorders, chronic use of medications that directly affect gastrointestinal
motility, severe chronic gastrointestinal diseases, or who had undergone gastrointestinal
surgery; (4) subjects with a history of acute or chronic pancreatitis, symptomatic
gallbladder disease, malignancy within five years prior to screening, medullary thyroid
carcinoma, or multiple endocrine neoplasia syndrome type 2A or type 2B.
T rial status: The Phase I clinical trial was initiated in June 2025. As of the Latest
Practicable Date, the LPLV had occurred and the database lock had been completed.
Safety data: XTL6001 demonstrated an overall favorable safety profile. No serious
adverse events were reported. Gastrointestinal adverse events were all Grade 1-2, with no
treatment discontinuation due to such events, and were dose-related. The incidence of
such adverse events may be reduced with a prolonged dose titration period.
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Efficacy data:
PK profile: XTL6001 exposure increases with dose escalation; Peak concentration is
reached 20-30 hours post-dose, with an elimination half-life of approximately 30 hours,
showing no significant differences between dose cohorts:
Time (h)
Conc. (ng/mL)
0 24 48 72 96 120 144 168
0
1000
2000
3000
4000
5000
6000
37.5 mg
75 mg
150 mg
300 mg
37.5 mg
75 mg
150 mg
300 mg
Effective Conc.
Time (h)
Log Conc.
0 24 48 72 96 120 144 168
1
2
3
4
5
Effective Conc.
Drug Time-Concentration and Semi-logarithmic Plots of XTL6001-I-C01 SAD Study (N=6/group)
Effective drug concentration maintained for >1 week: doses ≥150 mg can maintain
this effective concentration for over 168 hours (7 days), meeting the requirement for
once-weekly administration.
Reductions in Waist Circumference and Waist-to-Hip Ratio: in the MAD cohort,
after 4-5 weeks of treatment, subjects with BMI <28 kg/m² achieved a body weight
reduction of 2.06% to 2.21%. In obese subjects (BMI ≥28 kg/m²), waist circumference
decreased by approximately 2 cm, and waist-to-hip ratio (WHR) decreased by 0.015. The
reductions were sustained after treatment discontinuation: at two weeks following the last
dose, the total reduction reached 0.04 in WHR and 3.2cm in waist circumference.
The results indicate that XTL6001 leads to a substantially greater reduction in waist
circumference (visceral fat) compared to changes in hip circumference (subcutaneous fat
and muscle mass).
-0.05
-0.04
-0.03
-0.02
-0.01
0
D8 D15 D22 D29 D36
Change in Waist-to-Hip Ratio
from baseline (%)
Day (s)
-0.4
-1.58
-1.98 -1.78
-2.13
-4
-3
-2
-1
0
D8 D15 D22 D29 D36
Change in Waist Circumference
from baseline (cm)
Day (s)
Mean Change in Waist -to-Hip Ratio (WHR) from Baseline
Mean Change in Waist Circumference (WC) from Baseline (cm)
End of Dosing
End of Dosing
Persistence of effect observed
post-discontinuation
WC: Waist Circumference; WHR: Waist-to-Hip Ratio
Persistence of effect observed post-
discontinuation
XTL6001: -3.2cm
XTL6001: -0.04
D43 or Early Withdrawal
D43 or Early WithdrawalBaseline
Baseline
Source: Company data
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Reductions in Atherogenic Lipid Parameters: Compared with baseline, in obese
subjects, XTL6001 reduced triglycerides (TG) by 41.4%, low-density lipoprotein
cholesterol (LDL-C) by 30%, and apolipoprotein B (ApoB) by 26.6% at Week 5, suggesting
a robust lipid-lowering effect.
-45
-35
-25
-15
-5
D15 D29 D36
Mean (%)
Day (s)
TG (Triglycerides) %: TC (Total Cholesterol) %
LDL-C (Low-Density Lipoprotein Cholesterol) % ApoB (Apolipoprotein B) %
-25
-20
-15
-10
-5
0
D15 D29 D36
Mean (%)
Day (s)
-35
-25
-15
-5
D15 D29 D36
Mean (%)
Day (s) -30
-20
-10
0
D15 D29 D36
Mean (%)
Day (s)
XTL6001: 5W -41.4%
XTL6001: 5W -23.7%
XTL6001: 5W -30.0% XTL6001: 5W-26.6%
MAD Group 2 (BMI ≥ 28) | Mean Percent Change from Baseline (%), N=8
Baseline
Baseline Baseline
Baseline
Note: The potent lipid-lowering signals observed in healthy volunteers with normal baseline levels
Reduction in Serum Uric Acid (sUA) Levels: Compared with baseline, after four
weeks of treatment with XTL6001, sUA levels in all subjects decreased by 18.4% to 23.2%,
as compared to a reduction of 3.1% in the placebo group. Uric acid clearance increased by
approximately 40% compared with placebo. These results suggest that XTL6001 may
reduce sUA levels by decreasing uric acid production and promoting its excretion.
-12.5%
-18.4%
0.8
-5.1
-3.1
-25
-20
-15
-10
-5
0
5
D8 D15 D22
Mean change from baseline in sUA (%)
MAD_G1 BMI<28
MAD_G1 BMI≥28
Placebo
Baseline 12.9% 11.4%
-27.9%-30
-25
-20
-15
-10
-5
0
5
10
15
MAD G1_BMI<28 MAD G1_BMI≥28 Placebo
Mean change from baseline in Cua
(%)
Group
40% Improvement in UA Clearance vs. Placebo
XTL6001: 4W -23.2%
Source: Company data
BUSINESS
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Clinical Development Plan
The following table sets forth the planned clinical studies and plans for XTL6001 for
the treatment of obesity/weight loss, CKD with proteinuria, and MASH:
Indication Clinical T rial Location Upcoming Milestones
Chronic Weight
Management in
Obese or
Overweight
Populations ......
A randomized, double-blind,
controlled Phase II clinical trial
to evaluate the efficacy, safety,
and pharmacokinetics of
XTL6001 for injection in
obese/overweight subjects.
Sample size of approximately
240 subjects.
PRC The trial is planned to be
initiated in the third
quarter of 2026 and is
expected to be
completed in the third
quarter of 2027.
Proteinuric CKD .... A randomized, double-blind,
controlled Phase II clinical trial
to evaluate the efficacy, safety,
and pharmacokinetics of
XTL6001 for injection in
subjects with chronic kidney
disease and proteinuria. Sample
size of approximately 150
subjects
PRC The trial is planned to be
initiated in mid 2027
and is expected to be
completed in the fourth
quarter of 2027.
MASH ........... I N Dp r eparation stage PRC IND application expected
in early 2027
Material Communications
As of the Latest Practicable Date, we had not received any objection from any
relevant regulatory authorities to our clinical development plans. The following table sets
forth our important regulatory communications with regulatory authorities regarding the
development of XTL6001 for the treatment of obesity/weight loss and CKD with
proteinuria:
Indication Time
Regulatory
Authority Details
Chronic Weight
Management in
Obese or
Overweight
Populations .....
2024.5 FDA IND Submission
2024.12.20 FDA IND Approval
2025.2.12 NMPA IND Submission
2025.4.22 NMPA IND Approval
Proteinuric CKD . . . 2025.4.21 NMPA IND Submission
2025.6.30 NMPA IND Approval
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET XTL6001
SUCCESSFULLY
Our Key Product — MT1002
Our Key Product, MT1002, is a dual antagonist of coagulation factor II and the GP
IIb/IIIa receptor, primarily targeting clinical needs in anticoagulation and
anti-thrombosis for indications such as ACS-PCI, Stroke, HD and HD-PF4.
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Mechanism of Action
MT1002 simultaneously antagonizes coagulation factor II and GPIIb/IIIa,
possessing dual effects of anticoagulation and anti-platelet aggregation. It inhibits
thrombosis through dual pathways and has clinical advantages such as early onset,
convenient administration, no need for frequent monitoring, no dose adjustment required
in patients with hepatic or renal impairment, and prompt recovery of parameters after
discontinuation without affecting normal coagulation and platelet function.
MT1002
TxA2
FXa
TF
Prothrombin
Thrombin
Fibrinogen
Heparin
LMWH
Bivalirudin
Heparin
LMWH
Aspirin
ClopidogrelEptifibatide
Abciximab
Fibrin Thrombus
Thrombolytics
Platelets
Collagen WBC
Platelet
aggregation
Fibrinogen
crosslinking
Platelet
activation
Fibrin
degradation
TFPI
vWF ADP
Source: Company data
Coagulation factor II, namely thrombin (a serine protease in plasma), is generated
by activation of the liver-synthesized precursor prothrombin (the precursor of
coagulation factor II). It is a key enzyme in the coagulation cascade (a series of enzymatic
reactions leading to blood clot formation) that converts fibrinogen (a plasma protein
converted by thrombin into fibrin) into an insoluble fibrin mesh. It also promotes platelet
(cell fragments involved in hemostasis and thrombosis) activation and the activation of
other coagulation factors (enzymes and proteins involved in hemostasis), representing a
critical step in the formation of stable thrombus.
GPIIb/IIIa (integrin αIIbβ 3, an integrin receptor on the platelet membrane) is the
primary integrin receptor on the platelet surface. Upon activation of platelets by ADP
(adenosine diphosphate, a platelet activator), TXA
2 (thromboxane A 2, a platelet-secreted
pro-aggregatory substance), and vWF (von Willebrand factor, a glycoprotein mediating
platelet adhesion), this receptor undergoes a conformational change enabling it to bind
fibrinogen (fibrinogen, a plasma protein involved in thrombus formation) or vWF,
bridging multiple platelets to form aggregates — this is the core mechanism of white
thrombus formation (particularly arterial thrombosis).
Market Opportunities and Competition
ACS-PCI
ACS, a type of CHD, refers to a group of conditions that include ST-elevation
myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), and
unstable angina. ACS is related to sudden reduced blood flow to the heart. PCI is a
non-surgical, invasive procedure with a goal to relieve the narrowing or occlusion of the
coronary artery and improve blood supply to the ischemic tissue. From 2020 to 2025, the
volume of PCI procedures worldwide increased from 6.2 million to 10.7 million. It is
estimated that by 2030 and 2035, the volume of PCI procedures worldwide will reach 15.6
million and 21.7 million, respectively. From 2020 to 2025, the volume of PCI procedures in
China increased from 1.0 million to 2.3 million. It is estimated that by 2030 and 2035, the
volume of PCI procedures in China will reach 4.0 million and 6.0 million, respectively.
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PCI drugs are primarily used in patients with ACS who are scheduled to undergo
PCI. As of the Latest Practicable Date, there were three drugs with an indication for PCI
approved by the NMPA and three drugs with an indication for PCI approved by the FDA.
In addition, there were ten PCI drug candidates in the clinical stage globally, including
MT1002 (currently in Phase II).
Stroke
Stroke has become the leading cause of death and disability in China, posing a
significant threat to the health of residents as a major chronic disease. In China, the
prevalence of ischemic stroke grew from 18.6 million in 2020 to 23.5 million in 2025, and is
projected to reach 28.9 million by 2030 and 35.1 million by 2035.
HD
The number of patients receiving HD treatment worldwide increased from 3.3
million in 2020 to 3.7 million in 2025. It is projected to reach 4.6 million by 2030 and 5.5
million by 2035. In China, the number of patients receiving HD treatment grew from 0.7
million in 2020 to 1.1 million in 2025 at a CAGR of 10.1% and is projected to reach 1.8
million by 2030 and 2.8 million by 2035.
HD-PF4
HIT is one of the major adverse effects associated with commonly used
anticoagulants in dialysis. Type II HIT occurs when heparin forms a complex with platelet
factor 4 (PF4), inducing conformational changes that trigger the production of
autoantibodies. These antibodies lead to platelet activation, aggregation, and
consumption, and may also damage the vascular endothelium, resulting in arterial and
venous thrombosis, which is heparin-induced thrombocytopenia and thrombosis, (HITT).
The incidence of Type II HIT following initial heparin exposure ranges from 3% to 5%,
making it a potentially life-threatening and severe complication.
Competitive Advantages
(1) A direct thrombin + GP IIb/IIIa dual-target antagonist addresses the challenge of balancing
bleeding and ischemia in ACS-PCI.
Unfractionated heparin has a high bleeding risk and large inter-individual
variability, and some patients are intolerant to heparin treatment, leading to
heparin-induced thrombocytopenia; Certain existing anticoagulants may have a high risk
of acute in-stent thrombosis, increasing ischemic risk; Combination therapy (e.g., an
anticoagulant plus a GP IIb/IIIa inhibitor) tends to increase bleeding risk, and without an
established dosing basis for combined use, it is difficult to balance the risks of bleeding
and ischemia. As a “direct thrombin + GP IIb/IIIa dual-target antagonist,” MT1002’s
dual-function polypeptide design may address the challenge of balancing bleeding and
ischemia in ACS-PCI. It has demonstrated a favorable efficacy and safety profile in
ACS-PCI patients, and has the potential to overcome the limitations of conventional
anti-thrombotic regimens.
In the Phase II clinical trials in the U.S. and the PRC, MT1002 has shown good
efficacy and safety at various dose levels. In the U.S. trial, all 6 enrolled patients in the 0.90
mg/kg + 1.8 mg/kg/h × 4 hours dose group successfully completed the PCI procedure
without any MACE or major bleeding events. In the PRC trial, all 15 subjects who
underwent PCI successfully completed the procedure without any MACE or major
bleeding events. Combining the results of both trials, all subjects, under the effect of
MT1002’s anticoagulant and antiplatelet targets, successfully completed the PCI
procedure without any thrombotic or major bleeding events. There were no deaths, SAEs,
or early withdrawals due to TEAEs. All adverse events were mild or moderate, fully
validating its good safety and efficacy.
(2) MT1002 demonstrates dose-dependent anticoagulant and antiplatelet activity with early
onset and quick recovery after discontinuation. It can fill the therapeutic need in emergency
PCI where antiplatelet drugs have not taken effect or patients are unable to take oral
medication, while ensuring a good safety profile.
In the U.S. Phase II clinical trial, the treatment regimen of 0.90 mg/kg + 1.8
mg/kg/h × 4 hours for MT1002 was able to stably maintain the clinical anticoagulation
target during the procedure. In the PRC Phase II clinical trial, the pharmacodynamic effect
showed anticoagulant activity closely related to the administered dose, taking effect
within 5 minutes of administration. PD indicators returned to near-normal levels within 2
hours after discontinuation, validating MT1002’s characteristics of early onset and quick
recovery after withdrawal. For more information of the clinical results, see “— Clinical
Trial Overview of MT1002” below in this section.
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(3) Stable pharmacokinetic properties and good population adaptability
MT1002 has demonstrated consistent and stable pharmacokinetic and
pharmacodynamic profiles across different populations. The Phase II clinical study
showed that the in vivo exposure (Cmax and AUC) of MT1002 in ACS patients increased
with dose, demonstrating good dose dependency. The PK curve was consistent with the
Phase I results, showing no significant difference at the same dose levels, which supports
its stable pharmacokinetic characteristics. PK/PD modeling results further showed that
the typical values of ACT and APTT and their 95% confidence intervals were highly
consistent between the PRC and U.S. populations under the same dosing regimen,
verifying its good comparability across different ethnic groups. Furthermore, MT1002 is
primarily metabolized via plasma enzymatic hydrolysis, consistent with the
characteristics of a typical polypeptide drug. It is not affected by ethnic differences and
demonstrates good population adaptability.
Clinical Trial Overview of MT1002
MT1002-I-C01 U.S. Phase I Clinical Study
Overview: This is a randomized, open-label, sequential parallel-group, single-dose
escalation study. Its primary objective was to evaluate the safety and tolerability, and the
secondary objective was to characterize the pharmacokinetics and pharmacodynamics of
MT1002 in healthy subjects.
T rial design: 6 subjects were enrolled in each of the 5 cohorts (a total of 30 subjects)
to receive different bolus + infusion doses of MT1002. The total infusion time was 4 hours.
Pharmacokinetic and pharmacodynamic parameters were measured at different time
points after administration to assess the pharmacokinetic and pharmacodynamic
characteristics, while also evaluating the safety and tolerability of MT1002 in healthy
subjects. Subjects underwent follow-up until Day 8 from the initiation of dosing. No
additional administration was provided during the follow-up period.
A total of 30 healthy subjects were enrolled in this trial. The key inclusion criteria
included: (1) male or female subjects aged between 18 and 60 years; (2) BMI between 18.0
and 34.0 kg/m
2; (3) abstinence from xanthine-, quinine- or caffeine-containing beverages
and avoidance of prolonged intense physical activity during the study period (from 72
hours prior to dosing to the last visit). The key exclusion criteria included: (1) presence of
any medical condition, abnormal clinical laboratory findings or other circumstances that,
in the opinion of the investigator or designee, would render the subject unsuitable for the
study; (2) inability to tolerate venipuncture or poor venous access; (3) participation in
another investigational drug study and receipt of study treatment within 30 days or five
half-lives (whichever is longer) prior to the screening visit, or concurrent participation in
another clinical trial; (4) occurrence of acute illness within 14 days prior to the screening
visit; and (5) known hypersensitivity to MT1002 for injection.
T rial status: The Phase I clinical trial was initiated in April 2019 and is completed in
August 2019. A total of 30 healthy subjects completed the study drug administration in 5
dose groups. In a dose-escalation design, the safety and tolerability of MT1002 in healthy
individuals were explored across 5 dose groups (6 subjects per group). The Phase I clinical
trial was completed by the Group on its own.
Safety data: MT1002 for injection showed good safety and tolerability. No SAEs
were reported. No life-threatening AEs occurred, nor did any AE lead to patient
withdrawal or study discontinuation. All TEAEs were Grade 1 in severity with mild
symptoms, none of which required clinical intervention, and all subjects fully
recovered/resolved in a short period.
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Efficacy data:
infusion stopped
Cohort 1 (0.15+0.3)
Cohort 2 (0.3+0.6)
Cohort 3 (0.6+1.2)
Cohort 4 (0.9+1.8)
Cohort 5 (1.2+2.3)
ACT (S)
100
120
140
160
180
200
220
240
260
280
300
Time (h)
012 345678 9 10 11 12012 345678 9 10 11 12
Effect of MT1002 on anticoagulant indicator ACT
(N=6/group, dose unit: mg/kg + mg/kg/h)
01 23
Time (h)
45678 9 10 11 12
Cohort 1 (0.15+0.3)
Cohort 2 (0.3+0.6)
Cohort 3 (0.6+1.2)
Cohort 5 (1.2+2.3)
Cohort 4 (0.9+1.8)
infusion stopped infusion stopped
01 23
Time (h)
45678 9 10 11 12
Cohort 1 (0.15 +0.3)
Cohort 2 (0.3+0.6)
Cohort 3 (0.6+1.2)
Cohort 4 (0.9+1.8)
Cohort 5 (1.2+2.3)
Fold increase for APTT
0
10
20
30
40
50
60
70
80
90
100APTT (S)
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0.0
0.5
Effect of MT1002 on anticoagulant indicator APTT and the fold of its prolongation
(N=6/group, dose unit: mg/kg + mg/kg/h)
Source: Company data
Anticoagulant effect: MT1002 demonstrated a dose-dependent anticoagulant
activity by prolonging APTT, ACT, INR, PT, and TT. These parameters returned to the
normal range after discontinuation, with no impact on the human coagulation function.
0123456789 10 11 12
30
60
90
120
150
180
210
240
270
300
330 Cohort 1 (0.15+0.3)
Cohort 2 (0.3+0.6)
Cohort 3 (0.6+1.2)
Cohort 4 (0.9+1.8)
Cohort 5 (1.2+2.3)
infusion stopped
PA (S)
Time (h)
Effect of MT1002 on the anti-platelet indicator, platelet aggregation (PA) function
Note: The PA results for cohort 3 were not accurately obtained as most reported values were >134s due
to an equipment malfunction during sample testing.
Source: Company data
Anti-platelet effect: MT1002 prolonged platelet aggregation time, demonstrating a
dose-dependent anti-platelet activity. Platelets were immediately inhibited after
administration, and the function returned to the normal range after discontinuation, with
no impact on human platelet function.
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Results from the Phase I study demonstrated that MT1002 exhibited a favorable
safety profile, with pharmacokinetic and pharmacodynamic parameters showing a
consistent correlation. Dose-dependent anticoagulant and antiplatelet activities were
observed. Coagulation and platelet function returned to within normal ranges following
treatment discontinuation. The objectives set out in the overview were achieved.
MT1002-I-C02 PRC Phase I Clinical Study
Overview: This study adopted a single-center, randomized, double-blind,
placebo-controlled, single-dose escalation design. Its primary objective was to evaluate
the safety and tolerability, and the secondary objective was to characterize the
pharmacokinetics and pharmacodynamics of MT1002 for injection in healthy subjects in
the PRC.
T rial design: The study included a dose escalation/de-escalation study with 2 dose
groups. Each group consisted of 10 healthy subjects, with 8 receiving MT1002 and 2
receiving placebo. MT1002 was administered as a bolus injection followed by a continuous
4-hour infusion. Subjects underwent follow-up until Day 7 from the initiation of dosing.
No additional administration was provided during the follow-up period.
A total of 20 healthy subjects were enrolled in this trial. The key inclusion criteria
included: (1) aged 30 years or above, with children and no plans for future reproduction or
sperm/egg donation at the time of signing the informed consent form; (2) body weight not
less than 50.0 kg for males and 45.0 kg for females; and (3) BMI within the range of 18.0 to
28.0 kg/m². The key exclusion criteria included: (1) history of severe allergy or known
hypersensitivity to any component of the investigational product or its excipients; (2)
inability to comply with standardized meals or fasting requirements; and (3) history or
presence of clinically significant cardiovascular, cerebrovascular, hepatic, renal,
endocrine, metabolic, gastrointestinal, hematological, respiratory, infectious, oncological
or psychiatric disorders, as determined by the investigator.
T rial status: The Phase I clinical trial was initiated in September 2021 and is
completed in April 2022. A total of 6 subjects in dose group 1 and 7 subjects in dose group
2 completed the trial. All 4 subjects in the placebo group completed the trial. The Phase I
clinical trial was completed by the Group on its own.
Safety data: All TEAEs were Grade 1 or 2 in severity, with no clinical symptoms, and
did not require corresponding measures. No drug-related SAEs were reported. No
life-threatening AEs occurred, nor did any AE lead to patient withdrawal or study
discontinuation.
Efficacy data: After administration, coagulation indicators and platelet aggregation
time showed dose-dependent anticoagulant and anti-platelet activities. These functions
returned to the normal range after discontinuation, with no impact on human coagulation
or platelet function.
Phase I results showed good safety, linear pharmacokinetics with
dose-proportionality, and a clear PK/PD relationship. The objectives set out in the
overview were achieved.
MT1002-II-C01 U.S. Phase II Efficacy Study in NSTEMI-PCI Patients
Overview: A dose escalation/de-escalation study was conducted in the U.S. in
NSTEMI-PCI patients to evaluate the efficacy and safety of MT1002.
T rial design: The target population was patients with non-ST-segment elevation
myocardial infarction (NSTEMI) undergoing PCI. A total of 18 patients were planned for
enrollment into 3 dose groups of 6 patients each. All patients were to receive MT1002 via
bolus injection + 4-hour infusion during the peri-procedural period of PCI. Safety and
efficacy endpoints included BARC type 3-5 bleeding events and MACE events. PD
endpoints included coagulation-related indicators. Subjects underwent follow-up until
Day 30 from the initiation of dosing. No additional administration was provided during
the follow-up period.
A total of 6 subjects were enrolled in this trial. The key inclusion criteria included:
(1) male or female subjects aged ≥18 years and ≤85 years; (2) confirmed diagnosis of
NSTEMI; and (3) patients who were hospitalized for this episode of NSTEMI and planned
to undergo PCI. The key exclusion criteria included: (1) cardiogenic shock or a history of
prolonged cardiopulmonary resuscitation (CPR); (2) active bleeding, bleeding diathesis or
coagulopathy; (3) history of intracranial hemorrhage or structural abnormalities in the
brain; and (4) history of transient ischemic attack (TIA) or stroke within the past six
months.
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T rial status: The Phase II clinical trial was initiated in December 2020 and the study
for the first dose group has been completed, with a total of 6 subjects enrolled who
received MT1002 via bolus injection + continuous 4-hour infusion. The study was
terminated due to commercial considerations, primarily relating to the prioritization of
financial resources, and was not related to any safety or efficacy concerns. In March 2024,
we submitted an application to the FDA to terminate the trial, at which time one cohort of
six patients had completed dosing, all of whom successfully completed the procedure
without bleeding or thrombotic events, and no safety concerns were identified. We had
determined by the end of 2023 to prioritize clinical development in the PRC and initiated
a Phase II clinical trial. The Company intends to adopt a bridging strategy to potentially
waive the requirement for a separate Phase II trial in the U.S. and to consider conducting
an MRCT at the Phase III stage, with simultaneous implementation in both the PRC and
the U.S. and joint patient enrolment, with a view to reducing overall clinical development
costs, maintaining continuity of development and ultimately achieving concurrent
development in both markets. Our Directors confirm that the termination has no adverse
impact on the corresponding clinical development in the PRC and was not related to any
safety or efficacy concerns.
Safety data: Interim results showed that all 6 patients successfully completed the
PCI procedure without any thrombotic or major bleeding events. A total of 9 AEs were
reported by 2 subjects, the majority (66.7%) of which were mild. No drug-related SAEs
were reported. No life-threatening AEs occurred, nor did any AE lead to patient
withdrawal or study discontinuation.
Efficacy data: Interim results showed that after administration of MT1002, the
pharmacodynamic effect was exerted within 5 minutes, with anticoagulant indicators
reaching desired levels. All 6 patients successfully completed the PCI procedure without
any thrombotic or MACE events. MT1002 demonstrated early-onset characteristics,
meeting the urgent need for anticoagulation during the peri-procedural period of PCI and
providing timely and reliable protection against thrombosis.
MT1002-II-C04 PRC Phase II Efficacy Study in ACS-PCI Patients
Overview: This is a dose escalation/de-escalation study conducted in the PRC in
ACS-PCI patients. Its primary objective was to identify the safe and well-tolerated dose of
MT1002, and the secondary objective was to evaluate the safety and tolerability.
T rial design: The target population was ACS patients undergoing PCI, including
those with ST-segment elevation myocardial infarction (STEMI), non-ST-segment
elevation myocardial infarction (NSTEMI), and unstable angina (UA). A total of 53 to 65
patients are planned to be enrolled in six cohorts, including five dose-exploration cohorts
and one dose-expansion cohort. All patients are to receive MT1002 via bolus injection +
4-hour infusion during the peri-procedural period of PCI. Safety and efficacy endpoints
included BARC type 3-5 bleeding events and MACE events. PD endpoints included
indicators related to coagulation and platelet function. Subjects underwent follow-up
until Day 30 from the initiation of dosing. No additional administration was provided
during the follow-up period.
The key inclusion criteria included: (1) male or female subjects aged between 18 and
85 years; (2) subjects diagnosed with ACS who were hospitalized and planned to undergo
PCI; (3) subjects who were able to understand and willing to sign a written informed
consent form prior to any study-related procedures. The key exclusion criteria included:
(1) subjects with cardiogenic shock or those who had undergone CPR; (2) subjects
suspected of having aortic dissection, pericarditis or endocarditis; (3) subjects with a
history of intracranial hemorrhage or structural abnormalities in the brain; (4) subjects
who experienced TIA or stroke within the past six months; and (5) subjects with a history
of gastrointestinal or genitourinary bleeding within the past month.
T rial status: The Phase II clinical trial was initiated in February 2024. As of the
Latest Practicable Date, five dose-exploration cohorts involving a total of 24 subjects had
been completed, and enrollment of 26 subjects in the dose-expansion cohort was
completed.
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The relatively long interval between the Phase I and Phase II clinical trials was
primarily attributable to the prioritization of internal resources, with a focus on our Core
Product. In addition, MT1002 is an anticoagulant and antiplatelet drug, and its Phase III
clinical trial is expected to require a large sample size and significant investment.
Accordingly, the early-stage cohorts of the Phase II trial (MT1002-II-C04) employed a
small sample size (n=6 per cohort) appropriately designed to explore dose-level trends
and safety signals primarily in light of limited financial resources. Given the small sample
size and inherent inter-subject variability, such exploratory cohorts were not primarily
designed to establish a conclusive correlation between dose levels and clinical events.
Therefore, following improvements in our Company’s funding position, an
adequately-sized Phase IIb trial — forming part of the same MT1002-II-C04 study — is
being conducted to build upon these initial findings, enabling a robust assessment of the
exposure-response relationship between PD biomarkers and drug exposure, as well as a
preliminary exploration of MACE and bleeding events, which is necessary for informing
the subsequent large-scale Phase III trial.
Safety data: MT1002 demonstrated good safety and tolerability. As of the Latest
Practicable Date, one thrombotic event that was assessed as unrelated to the study drug
was reported, and no MACE events, NACE events, or BARC type 3-5 bleeding events
occurred. With the exception of one moderate AE unrelated to the study drug, all other
AEs were mild.
Efficacy data: After administration of MT1002, the pharmacodynamic effect was
exerted within 5 minutes. All 28 subjects successfully completed the PCI procedure
without any drug-related thrombotic or MACE events. The study showed that PCI
procedures could be successfully completed and thrombotic events prevented even with
an ACT of 200s or below, suggesting MT1002’s good ability to balance ischemic and
bleeding risks. It demonstrates the characteristic of preventing thrombosis at lower ACT
levels, thereby avoiding the high risk of major bleeding associated with traditional
anticoagulants. Unlike existing standard therapies, the synergistic anticoagulant and
anti-platelet effects of MT1002 ensure anti-thrombosis while avoiding the high risk of
major bleeding associated with traditional anticoagulants. After exploring the optimal
balanced dose in Phase II studies, a large-sample validation will be conducted in a Phase
III study.
Change of ACT-Time Mean±SEM
ACT=180s
Groups
Time (min)
ACT Mean (S)±SEM
Effect of MT1002 on
Activated Clotting Time (ACT)
in the PRC Phase II Clinical Study
Post-administration ATT/
Baseline APTT=1.5
Change of APTT from Baseline – Over Time Mean±SEM
Post-administration ATT/
Baseline APTT=2.5
Groups
Change of APTT from Baseline (fold) Mean±SEM
Time (min)
Effect of MT1002 on Activated
Partial Thromboplastin Time (APTT)
in the PRC Phase II Clinical Study
Source: Company data
Clinical Development Plan
For ACS-PCI: We plan to further communicate with the CDE in an EOP II meeting
after completing the PRC Phase II MT1002-II-C04 study, to advance a large-sample
confirmatory Phase III clinical study with NACE and MACE events as efficacy endpoints,
in support of a subsequent NDA filing.
For Stroke: We have obtained the PRC Phase II clinical trial approval and plan to
commence the Phase II clinical trial
(1) in the PRC by June 2026.
For HD: We have obtained the PRC Phase II clinical trial approval and plan to
commence the Phase II clinical trial (1) in the PRC by July 2026.
For HD-PF4: We have obtained the PRC Phase II clinical trial approval and plan to
initiate the PRC Phase II clinical trial (1) by the end of 2027.
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Note:
(1) The Phase I clinical trial of MT1002 had conducted adequate safety and dose-ranging evaluation
to support the therapeutic dose range for the treatment of stroke, HD and HD-PF4 in the PRC,
thereby providing the basis for directly commencing the respective Phase II clinical trials. The
relatively long interval between obtaining regulatory approval and commencing the relevant
clinical trials was primarily attributable to pipeline prioritization and the allocation of financial
resources. The Phase II clinical trial preparation was initiated in March 2026, including the
finalization of the clinical trial protocol.
Material Communications
As of the Latest Practicable Date, we had not received any objection from any
relevant regulatory authorities to our clinical development plans. The table below sets
forth our key regulatory communications with regulatory agencies regarding the
development of MT1002 for ACS-PCI, Stroke, HD, and HD-PF4:
Indication Time
Regulatory
Authority Details
ACS-PCI ......... 2019.1 FDA IND Submission
2019.3.1 FDA IND Approval
2021.3.10 NMPA IND Submission
2021.6.2 NMPA IND Approval
2022.12.27 NMPA EOP1 Meeting
2024.8.15 NMPA EOP2 Meeting
S t r o k e ........... 2023.4.17 NMPA IND Submission
2023.6.25 NMPA IND Approval
H D ............. 2023.10 FDA IND Submission
2023.11.13 FDA IND Approval (1)
2023.5.18 NMPA IND Submission
2023.7.27 NMPA IND Approval
HD-PF4 .......... 2023.3.22 NMPA IND Submission
2023.6.6 NMPA IND Approval
Notes:
(1) For the treatment of HD in the U.S., we have not yet formulated a definitive clinical development
plan and has not commenced any clinical trials as of the Latest Practicable Date despite obtaining
IND approval from the FDA in 2023. We are exploring potential collaboration opportunities with
overseas partners and may initiate clinical development upon securing an appropriate
collaboration arrangement.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET MT1002
SUCCESSFULLY
Our Key Product — MT200605
Our Key Product, MT200605, is a neuroprotectant for injection. Its core
breakthrough lies in a dual synergistic mechanism of action — by simultaneously
activating the TrkB receptor and eliminating oxygen radicals, it blocks the post-acute AIS
pathological cascade via dual pathways, offering a therapeutic solution for patients with
currently unmet clinical needs.
Mechanism of Action
MT200605 has a dual mechanism of action: on one hand, by activating the TrkB
receptor, it initiates the BDNF signaling pathway, further activating signaling pathways
such as ERK, PI3K/Akt, and PLC. This promotes the growth, repair, and regeneration of
neural cells, counteracts damage from toxic substances, enhances learning and memory
functions, and demonstrates a significant neuroprotective effect in stroke models. On the
other hand, it exerts the anti-oxygen free radical effect of flavonoids. Acute ischemic
stroke leads to the release of a large number of reactive oxygen species, triggering
inflammatory responses and ischemia-reperfusion injury. Flavonoid compounds possess
multiple mechanisms, including directly blocking or scavenging free radicals, inhibiting
lipid peroxidation, and chelating with metal ions, thereby exerting antioxidant and
neuroprotective effects.
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MT200605
1-$Z 1*,",U . "1,&3,
TrkB activation
Blood-brain barrier
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Source: Company data
TrKB receptor is a transmembrane receptor with tyrosine kinase activity in the Trk
family, which mainly binds to brain-derived neurotrophic factor and neurotrophin-4/5.
After binding to ligands, TrKB receptor activates the downstream signaling pathways
such as PI3K/Akt, MAPK/ERK, and PLCγ by dimerization, and regulates neuronal
survival, proliferation and differentiation, axonal dendritic development, and synaptic
plasticity, which is essential for the development of the nervous system, It is a core
molecule in the development of the nervous system, maintenance of function and repair of
damage.
TrKB receptor agonist binds to TrKB and exerts neuroprotective effects through
multiple mechanisms: activating the PI3K/Akt pathway to inhibit neuronal apoptosis and
reduce ischemic or toxic injury; promoting axonal regeneration and synaptic
reconstruction via the MAPK/ERK pathway to facilitate the repair of the neural network;
enhancing the regulation of PLCγ -mediated calcium signaling to improve synaptic
transmission and alleviate cognitive impairment; down-regulating proinflammatory
drugs; and down-regulating the calcium signaling pathway to improve synaptic
transmission and alleviate cognitive impairment. It also enhances PLC γ-mediated calcium
signaling and improves synaptic transmission to alleviate cognitive deficits;
down-regulates the pro-inflammatory pathway to inhibit glial over-activation and reduce
inflammatory damage; and stimulates neurogenesis in the hippocampus and other
regions to facilitate functional recovery. These potential multiple therapeutic mechanisms
make TrKB agonists have the potential to treat stroke, neurodegenerative diseases,
depression and other neurological disorders.
Market Opportunities and Competition
AIS is the most common type of stroke, accounting for about 70%-80% of strokes.
The global prevalence of ischemic stroke grew from 65.7 million in 2020 to 85.3 million in
2025, and is projected to reach 105.8 million by 2030 and 127.4 million by 2035. In China,
the prevalence of ischemic stroke grew from 18.6 million in 2020 to 23.5 million in 2025,
and is projected to reach 28.9 million by 2030 and 35.1 million by 2035.
As of the Latest Practicable Date, there are three neuroprotective drugs approved by
NMPA. In addition, there were a total of 12 neuroprotective drug candidates for AIS in the
clinical stage in the PRC, including our Key Product MT200605 (currently in phase II). For
more information, see “Industry Overview — Main treatment of Ischemic Stroke” and
“Industry Overview — Competitive landscape of neuroprotective drugs.”
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Competitive Advantages
(1) Favorable safety and tolerability profile
MT200605 has successfully completed Phase I clinical studies in both the PRC and
the U.S. Study results showed that MT200605 has good safety and tolerability in healthy
subjects. All TEAEs related to MT200605 were Grade 1, with no SAEs or events leading to
subject withdrawal. All adverse events were resolved or recovered, further validating the
safety foundation of MT200605 as a neuroprotective agent for stroke in the early clinical
stage. Furthermore, results from the Phase I single and multiple dose studies indicated
that the in vivo exposure of MT200605 is clearly linearly correlated with the dose,
demonstrating a good dose-exposure relationship. There was no accumulation after
multiple administrations, providing support for subsequent dose exploration and clinical
application. For more information of the clinical results, see “— Clinical Trial Overview of
MT200605” below in this section.
(2) Synergistic neuroprotective effect via dual pathways
MT200605 has a well-defined dual mechanism of action, which is supported by
existing clinical data. On one hand, the drug promotes neurogenesis by activating the
TrkB receptor; on the other hand, it leverages the antioxidant properties of flavonoids to
inhibit free radical damage, thereby achieving a synergistic neuroprotective effect.
Existing preclinical pharmacodynamic studies (MCAO-CIR rat model) show that
MT200605 is well-distributed in brain tissue and has the ability to cross the blood-brain
barrier; it is more effective existing neuroprotective agents in improving stroke-related
behavioral indicators, increasing brain SOD and GSH-Px content, reducing cerebral
infarction volume, prolonging the survival rate of model mice, and delaying the time of
animal death, demonstrating significant therapeutic advantages and good development
potential.
Sham
Vehicle
Edaravone 4.9 mg/kg
MT200605 0.45 mg/kg
MT200605 1.35 mg/kg
MT200605 4.05 mg/kg
MT200605 sc 1.35 mg/k
g
Percent survival
day
0
0
50
100
150
2468 1 0
Sham Vehicle Edaravone 4.9 0.45 1.35 4.05 sc 1.35
0
1
2
3
MT200605
mg/kg
***
##
# ##
#
Behavior score
MT200605 can significantly prolong the
survival rate of model rats and delay the
time of death.
(79.2% vs. Edar 44.8%, n=10~29)
MT200605 can reduce the behavioral
scores of rats in a dose-dependent
manner.
(n=10~29)
Sham Vehicle Edaravone 4.9 0.45 1.35 4.05 sc 1.35
0
10
20
30 ***
####
MT200605
mg/kg
###
Percentage of infarct volume (%)
Vehicle (97”)
MT200605 0.45mg/kg (77”)
MT200605 4.05mg/kg (118”)
MT200605 1.35mg/kg (75”)
MT200605 sc 1.35mg/kg (120”)
Sham (279”)
Edaravone (81”)
Effect on the percentage of cerebral
infarction volume in rats
(n=10-19) ***P<0.001 vs. Sham; #P<0.05,
##P<0.01 vs. Vehicle
Typical photos of cerebral infarction
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Sham Vehicle Edaravone 4.9 0.45 1.35 4.05 sc 1.35
0
20
40
60
80
MT200605
mg/kg
SOD (U/ml)
Sham Vehicle Edaravone 4.9 0.45 1.35 4.05 sc 1.35
0
100
200
300
MT200605
mg/kg
**
# ##
### ###
GSH-Px (nmol/min/mL)
MT200605 increases SOD content
(44.7% vs. Edar 13.7%, n=10~29)
MT200605 increases GSH-Px content
(52.6% vs. Edar 31.3%, n=10~29)
Source: Company data
Clinical Trial Overview of MT200605
MT200605-I-C01 PRC Phase I Clinical Study
Overview: We conducted a randomized, double-blind, placebo-controlled Phase I
clinical trial in healthy subjects in the PRC to evaluate single ascending dose (SAD) and
multiple ascending dose (MAD) administration of MT200605 for injection. Its primary
objective was to evaluate the safety and tolerability, and the secondary objective was to
characterize the pharmacokinetic of MT200605 in healthy individuals in the PRC, and to
recommend the optimal dosing regimen and dose for Phase II clinical trials.
T rial design: This was a single-center, Phase I, randomized, double-blind,
placebo-controlled, sequential-dosing SAD and MAD study. The SAD study consisted of 5
cohorts (MT200605 0.15mg/Kg, 0.3mg/Kg, 0.6mg/Kg, 0.9mg/Kg, and 1.2mg/Kg, single
dose). The 4 subjects in the first cohort all received MT200605, while the remaining cohorts
each had 8 subjects (6 on MT20060 5+2o nplacebo). A total of 36 healthy subjects were
enrolled in the entire SAD study. The MAD study comprised 3 cohorts (0.3mg/Kg,
0.6mg/Kg, and 1.2mg/Kg, dosed every 12 hours for 7 consecutive days), with 8 subjects in
each cohort (6 on MT20060 5+2o nplacebo), for a total of 24 subjects. Subjects in the SAD
study will undergo follow-up 11 days after dosing, while those in the MAD study will
undergo follow-up 7 days after completion of dosing. The primary endpoint of the study
was the safety and tolerability of MT200605 in healthy subjects, with its pharmacokinetic
characteristics as a secondary endpoint.
A total of 60 subjects were enrolled in the PRC in this trial. The key inclusion criteria
included: (1) subjects aged between 18 and 50 years at the time of screening, with a BMI of
no less than 18.0 kg/m² and no more than 28.0 kg/m²; (2) healthy subjects without
clinically significant medical history or conditions; (3) subjects with no plan for
conception, sperm donation or egg donation within six months following screening, who
voluntarily agree to use effective contraceptive measures, and for female subjects, with a
negative serum pregnancy test result; and (4) subjects who are able to understand the
study procedures and have signed the informed consent form prior to participation in the
study. The key exclusion criteria included but were not limited to: (1) any clinically
significant abnormal findings identified during physical examination; (2) any clinically
significant abnormalities in laboratory test results at screening, or positive findings for
HBsAg, anti-HCV antibody, HIV antibody, serological testing, or active infection; (3)
female subjects with a positive pregnancy test result or who are lactating; (4) positive
results in urine drug screening or breath alcohol test; and (5) a clinically significant
history of allergic reactions, such as anaphylaxis, hypersensitivity or angioedema, as
determined by the investigator.
T rial status: The Phase I clinical trial was initiated in July 2023 and completed in
December 2023 with 60 subjects enrolled in the PRC. We completed the Phase I clinical
trial on our own.
Safety data: The PRC Phase I clinical study showed a good safety profile. No
drug-related TEAEs of Grade 3 or above were observed, and no drug-related SAEs were
reported. No life-threatening AEs occurred, nor did any AE lead to patient withdrawal or
study discontinuation. The objective set out in the overview was achieved.
Pharmacokinetic data: The SAD study showed that within the 0.15mg/kg to
1.2mg/kg range, the pharmacokinetic (PK) characteristics of both total MT200605 and free
MT200605 showed a clear positive dose-exposure correlation, and the main
pharmacokinetic parameters followed linear kinetic characteristics. The MAD study
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showed that within the 0.3mg/kg to 1.2mg/kg range, there was no significant
accumulation after multiple doses of MT200605, and steady state trough concentration
was reached on day 5. The main pharmacokinetic parameters of free MT200605 followed
linear kinetic characteristics, while the increase in exposure (AUC0-t,ss) of total MT200605
was slightly higher than dose-proportional (approximately 1.85-fold).
0.15mg/kg
0.3mg/kg
0.6mg/kg
0.9mg/kg
1.2mg/kg
0.15mg/kg
0.3mg/kg
0.6mg/kg
0.9mg/kg
1.2mg/kg
Infusion stopped Infusion stopped
Conc. (ng/ml)
Log Conc.
1500
1200
900
600
300
0
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0 1 2 3 4 5 6 7 8 0 1 2 3 4 5 6 7 8
Time (h) Time (h)
Time-Concentration and Semi-logarithmic Plots of MT200605 Parent Drug in Each
Dose Group of the MT200605 SAD Study
(N=6/group)
0.15+0.15mg/kg/d
0.3+0.3mg/kg/d
0.6+0.6mg/kg/d
Infusion stopped
0 1 2  3  4 5 72 144 168 170 172
Conc. (ng/ml)
Time (h)
900
800
700
600
500
400
300
200
100
0
Time-Concentration Plots of MT200605 Parent Drug in Each Dose Group of the
MT200605 MAD Study
(N=6/group)
Source: Company data
Results from the Phase I study demonstrated a favorable safety profile of MT200605,
with pharmacokinetic parameters showing a linear correlation with the administered
dose. The objectives set out in the overview were achieved.
MT200605-101-US U.S. Phase I Clinical Study
Overview: We conducted a randomized, double-blind, Phase I clinical trial in the
U.S. to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses
(SAD) of MT200605 for injection in healthy subjects. Its primary objective was to evaluate
the safety and tolerability, and the secondary objective was to characterize the
pharmacokinetic of MT200605 in healthy subjects in the U.S., and to recommend the
optimal dosing regimen and dose for Phase II clinical trials.
T rial design: The U.S. Phase I clinical study included 2 cohorts (MT200605
0.1mg/Kg and 0.3mg/Kg), both with single-dose administration. Each cohort comprised 8
subjects (6 on MT20060 5+2o nplacebo). Subjects will undergo a safety follow-up
assessment 7 days after dosing. A total of 16 healthy subjects were enrolled in the study.
A total of 16 subjects were enrolled in the US in this trial. The key inclusion criteria
included: (1) male or non-childbearing potential female, ≥ 18 and ≤ 65 years of age with
BMI ≥ 18.0 and ≤ 32.0 kg/m
2 at screening; (2) healthy subject without clinically significant
medical history or conditions; (3) female subjects of non-childbearing potential; (4) female
subjects (except for post-menopausal women) must have agreed to use two forms of
acceptable non-hormonal methods of contraception, for the duration of the study and for
30 days following the completion of the study; and (5) subjects able to understand the
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study procedures and provide signed informed consent to participate in the study. The
key exclusion criteria included but were not limited to: (1) any abnormalities identified
during physical examination (including examination of the administration site); (2)
abnormal laboratory test results at screening, or positive findings for hepatitis B surface
antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, HIV antigen or antibody, or
evidence of active infection; (3) positive pregnancy test result or lactation at screening; (4)
positive urine drug screening, positive urinary cotinine test or positive breath alcohol test;
and (5) a history of severe allergic reactions (e.g., anaphylaxis, hypersensitivity or
angioedema) considered clinically significant by the investigator.
T rial status: The Phase I clinical trial was initiated in October 2022 and completed in
January 2023 with 16 subjects enrolled in the US.
Safety data: The U.S. Phase I clinical study showed a good safety profile. No
drug-related TEAEs of Grade 3 or above were observed, and no drug-related SAEs were
reported. No life-threatening AEs occurred, nor did any AE lead to patient withdrawal or
study discontinuation.
Pharmacokinetic data: The increase in pharmacokinetic exposure of free MT200605
was dose-proportional, whereas the increase in pharmacokinetic exposure of total
MT200605 was slightly greater than dose-proportional. MT200605 is minimally excreted
in urine. At doses of 0.1 mg/kg and 0.3 mg/kg, the percentage of urinary excretion was
0.07% and 0.10% for free MT200605, and 2.46% and 5.39% for total MT200605, respectively.
The Phase I study demonstrated that MT200605 had a favorable safety profile and
exhibited linear pharmacokinetic characteristics with dose-proportional exposure. The
objectives set out in the overview were achieved.
MT200605-II-C01 PRC Phase II Clinical Study
Overview: This is a multi-center, randomized, double-blind, placebo-controlled
study in patients with acute ischemic stroke in the PRC. Its purpose is to investigate the
efficacy, safety, and pharmacokinetic characteristics of different doses of MT200605 in
patients with acute ischemic stroke, and to explore an appropriate dose for the Phase III
confirmatory trial. Efficacy evaluation was the primary objective of the study.
T rial design: The study will select 360 patients with acute ischemic stroke within 24
hours of onset and an NIHSS score between 6 and 25 (inclusive), including those who have
or have not received intravenous thrombolysis or reperfusion therapy. They will be
randomized in a 1:1:1:1 ratio into low, medium, and high dose groups of MT200605 and a
placebo group, to receive intravenous infusions of MT200605 at 10 mg BID, 20 mg BID, 40
mg BID, or placebo for 14 consecutive days, followed by a follow-up period up to day 90
from the first dose. The primary efficacy endpoint of the study is the proportion of
subjects with a modified Rankin Scale (mRS) score of ≤1 on day 90 after onset. A secondary
efficacy endpoint is the change in NIHSS score from baseline within 14 days of treatment.
A total of 360 subjects are planned to be enrolled in this trial. The key inclusion
criteria included: (1) male or female subjects aged 18 years or above and no more than 80
years; (2) subjects diagnosed with ischemic stroke in accordance with the Guidelines for
the Diagnosis and Treatment of Acute Ischemic Stroke in China (2023); (3) subjects whose
onset of symptoms and expected administration of the investigational product occurred
within 24 hours, including those who had not received reperfusion therapy or who had
received intravenous thrombolytic therapy; and (4) subjects who were able to understand
and comply with the study procedures and voluntarily signed the informed consent form.
The key exclusion criteria included but were not limited to: (1) subjects with intracranial
hemorrhagic diseases confirmed by imaging examinations; (2) subjects presenting with
significant disturbance of consciousness after onset, defined as a score greater than 1 on
item 1a (level of consciousness) of the NIHSS; (3) subjects with TIA; and (4) subjects
requiring endovascular therapy for the current acute ischemic stroke, including
intra-arterial thrombolysis, mechanical thrombectomy or angioplasty.
T rial status: The Phase II clinical trial was initiated in July 2025 and enrollment of
360 subjects has been completed as of the Latest Practicable Date. The gap between the
completion of our Phase I clinical trial and the initiation of the Phase II clinical trial was
primarily due to our prioritization of financial resources toward our Core Product
MT1013.
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Clinical Development Plan
The Phase II study of MT200605 is a randomized, double-blind, placebo-controlled,
multi-center Phase II clinical study designed to explore the efficacy, safety, and
pharmacokinetic characteristics of MT200605 in patients with acute ischemic stroke. We
expect to complete this study in August 2026, with EOP2 communications planned
thereafter.
We have not yet formulated a definitive clinical development plan in the U.S., and
are exploring potential collaboration opportunities with overseas partners. The absence of
a U.S. plan is primarily due to financial resource allocation considerations rather than any
safety or efficacy concerns. Based on available data to as of the Latest Practicable Date,
MT200605 has demonstrated an acceptable safety profile and preliminary efficacy signals.
Material Communications
As of the Latest Practicable Date, we had not received any objection from any
relevant regulatory authorities to our clinical development plans.
The table below sets forth our key regulatory communications with regulatory
agencies regarding the development of MT200605 for the treatment of ischemic stroke:
Time Regulatory Authority Details
2021.11 ............. F D A I N DSubmission
2021.12.29 .......... F D A I N DA p p roval
2023.1.5 ............ N M P A I N DSubmission
2023.3.24 ........... N M P A I N DA p p roval
2025.3.13 ........... N M P A E O P 1Meeting
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET MT200605
SUCCESSFULLY
MT2004
MT2004 adopts a prodrug design, leveraging concentration gradients inside and
outside hepatocytes to achieve targeted delivery to the liver. Non-clinical studies
demonstrated that the parent compound MT2004 does not activate FXR, while its
metabolite MT2004-met1 significantly activates the FXR receptor, with an efficacy
approximately 10 times stronger than chenodeoxycholic acid (CDCA), thereby validating
the rationale of its prodrug design.
Following hepatic metabolism by CYP3A4 and CYP3A5 into the active metabolite
MT2004-met1, the compound specifically and locally activates hepatic FXR receptors in
situ. By modulating bile acid metabolism (inhibiting bile acid synthesis, reducing bile acid
reabsorption, and promoting bile acid excretion) as well as glucose and lipid metabolism,
MT2004 is designed to alleviate cholestasis and its clinical symptoms, slow disease
progression, and repair liver damage. This targeted design avoids the high systemic
exposure of FXR agonists in peripheral blood, which has been associated with adverse
events, and has the potential to substantially reduce side effects observed with existing
FXR agonists in clinical use. As a result, MT2004 may provide a more favorable safety
profile and improve patient compliance.
Preclinical studies have demonstrated therapeutic potential in DILI, NASH, and
CLD. MT2004 has obtained IND approval in the United States for the treatment of NASH
and in the PRC for the treatment of DILI, MASLD, and CLD. For DILI in the PRC, we
independently completed the Phase I clinical trial in January 2023, and initiated the Phase
II clinical trial in July 2023. For MASLD in the U.S., the Phase I clinical trial commenced in
January 2020 and was completed in April 2022. Phase I clinical trials of MT2004 has
demonstrated favorable safety and tolerability profile, with no pruritus or related adverse
events reported.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET MT2004
SUCCESSFULLY
MT1009
MT1009 is a novel bi-specific fusion peptide with dual functional domains of
parathyroid hormone-related peptide (PTHrP) and OGP . MT1009 exerts the effects of
PTHrP by enhancing bone formation, activating the PTH1 receptor, and reproducing most
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of the functions of iPTH, including promoting bone resorption and mobilizing calcium
and phosphorus into the bloodstream. In addition, through activation of the OGP
pathway, MT1009 increases the number of osteoblasts and stimulates the release of
osteogenic growth factors from osteoblasts, thereby further promoting bone formation.
MT1009 is intended for the prevention of glucocorticoid-induced osteoporosis in
patients at moderate to high risk with long-term glucocorticoid use, as well as for the
treatment of postmenopausal osteoporosis and primary or hypogonadism-induced
osteoporosis. Compared with conventional anti-osteoporosis therapies (such as
bisphosphonates, teriparatide, and abaloparatide), MT1009 has demonstrated the
potential to significantly increase bone mineral density (BMD), improve bone quality (by
rebuilding trabeculae, thickening cortical bone, and repairing microfractures), and
achieve a more pronounced reduction in fracture risk. MT1009 has obtained IND
approvals in both the PRC and the United States. The Phase I clinical trial of MT1009
obtained informed consent from the first subject in January 2026. As of the Latest
Practicable Date, the clinical trials for both GIOP and PMO are temporarily suspended
pending further formulation optimization, primarily due to our Company’s focus on the
development of an oral formulation, instead of the current daily injectable formulation,
which may provide improved convenience for long-term administration and product
differentiation. Such suspension was not related to any safety or efficacy concerns.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET MT1009
SUCCESSFULLY
MT1011
MT1011 is a novel synthetic small-molecule broad-spectrum anticoagulant reversal
agent targeting both thrombin factor IIa inhibitors and factor Xa inhibitors. MT1011 binds
directly to anticoagulant molecules through non-covalent hydrogen bonding without
binding to coagulation factors or other plasma proteins. This direct antagonistic
mechanism neutralizes the anticoagulant activity and restores normal coagulation.
MT1011 is intended for use in patients receiving anticoagulant therapy (such as
factor Xa inhibitors rivaroxaban or apixaban) who require urgent reversal of
anticoagulation due to life-threatening or uncontrolled bleeding. MT1011 addresses the
significant unmet clinical need for a broad-spectrum reversal agent by antagonizing all
NOACs as well as heparin/enoxaparin in cases of life-threatening or uncontrolled
bleeding.
MT1011 demonstrates a favorable safety profile by directly binding to
anticoagulants without interacting with coagulation factors or other plasma proteins,
thereby avoiding off-target effects. MT1011 also offers a wider therapeutic window, with a
significantly lower effective dose for antagonizing factor Xa inhibitors (demonstrating
equivalent effects at doses approximately 380 times lower than ciraparantag). The Phase I
clinical trial of MT1011 in the PRC commenced in April 2025. As of the Latest Practicable
Date, the LPLV had been completed.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET MT1011
SUCCESSFULLY
OUR NON-PIPELINE PRODUCT CANDIDATES
XTL3602
XTL3602 is designed as a tri-agonist targeting GLP-1R, GCGR, and GIPR with
balanced activity across the three receptors. The molecule incorporates fatty acid chain
modification to achieve an extended half-life for long-acting activity, while maintaining
activity and balance across all three targets. XTL3602 is intended for the treatment of
metabolic diseases, including obesity, diabetes, and obstructive sleep apnea associated
with obesity; non-alcoholic fatty liver disease by reducing hepatic fat deposition through
weight loss; secondary prevention of cardiovascular events by exploring the role of
weight reduction in lowering cardiovascular risk. We expect to submit an IND application
in 2027 to advance XTL3602 into clinical development.
XTL3710
XTL3710 is designed as a tri-agonist targeting GLP-1R and GCGR with the
introduction of MasR to achieve balanced activity across three receptors. The molecule
incorporates fatty acid chain modification to extend half-life and enable once-weekly
administration, while maintaining activity and balance across all three targets. XTL3710 is
intended for the treatment of metabolic diseases caused by multiple risk factors, including
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diabetes and diabetic kidney disease (DKD). IND submission is planned in 2026 to
advance XTL3710 into clinical development.
MT1016
MT1016 is a selective peripheral kappa opioid receptor (KOR) agonist and a
long-acting peptide (administered via subcutaneous injection) designed for more effective
and safer treatment of pain and pruritus. We expect to submit an IND application in 2027
to advance MT1016 into clinical development. We believe MT1016 has the potential to
offer more effective management of visceral pain and promotes faster postoperative
gastrointestinal function recovery. MT1016 may also reduce central nervous
system-related adverse effects and provides long-acting analgesia, thereby decreasing the
need for frequent use of analgesic pumps.
XTL1018
XTL1018 is a bi-specific peptide–drug conjugate (PDC) candidate targeting
complement C3 and TrkB. The design links a peptide targeting complement C3 with a
small molecule modulator of TrkB, which exerts neuroprotective activity. By inhibiting
excessive activation of the complement cascade and suppressing inflammatory responses,
while simultaneously modulating the BDNF/TrkB signaling pathway, XTL1018 is
expected to exert biological effects that prevent downstream inflammation and cell
damage associated with geographic atrophy (GA) and restore impaired neuroprotective
signaling in GA. Accordingly, XTL1018 is intended for the treatment of late-stage dry
AMD with GA. We expect to submit the IND application for XTL1018 in 2028 to initiate
clinical development.
WE MAY NOT ULTIMATELY BE SUCCESSFUL IN DEVELOPING AND
MARKETING OUR NON-PIPELINE PRODUCT CANDIDATES.
OUR TECHNOLOGY PLATFORMS
We have self-developed four core technology platforms including (i)
Bi-/Multi-Specific Peptide and Peptide-based Macromolecule Technology Platform, (ii)
Computer-Aided Peptide Design Platform, (iii) Oral Peptide Delivery Platform, and (iv)
Druggability Evaluation Platform. These platforms collectively span the entire R&D
continuum from basic research, drug discovery research, drug development research to
NDA submission and serve as the foundational engine driving the advancement of our
differentiated peptide-based pipeline.
R&D process
Basic Research Discovery Research
Bi-/Multi-specific Peptide and
Peptide-based Macromolecule
Technology Platform
Computer-aided Peptide
Design Platform
Oral Peptide Delivery Platform
Druggability Evaluation Platform
Drug Development
Research NDA Submission
Bi-/Multi-specific Peptide and Peptide-based Macromolecule T echnology Platform
The pathogenesis of diseases often involves the interplay of multiple targets. Unlike
the traditional drug development pathway, which typically begins with a single target
followed by high-throughput screening to identify hit compounds, optimization into lead
compounds, advancement into PCCs, pre-clinical development and ultimately clinical
studies, our Bi-/Multi-specific Peptide Platform has established a novel R&D paradigm,
covering key stages including target selection, structure–activity relationship analysis,
design optimization, computer-based modeling, synthesis and target validation.
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Lead compound design and optimization: In the design and optimization of lead
compounds, we adopt a dual approach. On the one hand, we leverage structural
information from reported drugs and clinically validated active compounds and apply
classical medicinal chemistry principles in conjunction with computer-aided drug design
molecular simulation to rationally construct novel molecules. On the other hand, we
conduct screening of our compound list to identify hit or lead compounds with
development potential. For the design of bi-/multi-functional peptides, we primarily
adopt the following three strategies: (i) linker fusion technology, to maximize biological
activity, reduce adverse effects, optimize pharmacokinetic profiles, enhance stability,
extend half-life, and improve dosage form and patient compliance; (ii) chimeric
technology, to enhance bioactivity, reduce immunogenicity, and prolong half-life; and (iii)
conjugation-extension technology, to construct extended molecular conformations with
multiple physiological functions, thereby addressing clinical needs across various
therapeutic areas.
Diversified molecular entity design to meet druggability requirements: Starting
from clinical application scenarios, we select the most suitable molecular structures by
evaluating the characteristics of linear peptides, monocyclic peptides, and bicyclic
peptides. (i) linear peptides are easy to synthesize and highly amenable to chemical
modification, allowing generation of structurally diverse candidate compounds. (ii) cyclic
peptides demonstrate significant advantages in both pharmacological and
pharmacokinetic properties, such as enhanced metabolic stability, improved target
specificity and selectivity, as well as favorable biophysical attributes. (iii) bicyclic
peptides combine cell membrane permeability with a large interaction interface, allowing
them to bind to protein targets independently of conventional binding pockets, thereby
enabling precise targeting of previously undruggable targets.
Peptide chemical modification technologies: We apply strategies such as
non-natural amino acid substitution, site-specific mutagenesis, cyclization, PEGylation,
and long-chain fatty acid esterification to improve druggability, including enhancing
resistance to proteolytic degradation, reducing antigenicity, prolonging in vivo half-life,
and increasing bioavailability.
Although peptide-based therapeutics offer high target specificity and favorable
safety profiles, their clinical applications are limited by poor metabolic stability and short
biological half-life, particularly in indications requiring long-term administration such as
chronic diseases, which may affect patient adherence and treatment experience. To
address these limitations, we have established a macromolecule platform based on
functional peptides as an extension of our Bi-/Multi-Specific Peptide Platform. This
platform leverages macromolecular modification to significantly extend the half-life of
peptide drugs, improve their metabolic stability, enable targeted delivery, enhance drug
specificity and reduce adverse drug reactions.
Based on this technology platform, we have generated and developed a number of
clinically promising candidate molecules with diverse molecular formats and mechanisms
of action. Among them, four candidates — MT1013, MT1002, XTL6001 and MT1009 have
entered clinical development. Another three candidates — XTL3710 and XTL3602 — have
completed hit-to-lead validation, and peptide-drug conjugate MT1018 has completed PCC
selection.
Computer-aided Peptide Design Platform
Our Computer-aided Peptide Design Platform integrates multiple functional
modules, including virtual screening, molecular dynamics simulation, SAR prediction
and ADMET prediction, and is supported by advanced hardware, enabling operation
without compromising accuracy to meet our needs in compound virtual screening. Built
on the principles of computational chemistry, structural biology and biophysics, and
supported by various open-source databases, the platform is operated by an experienced
domestic peptide early research team, thereby reducing time and cost, enhancing R&D
efficiency and improving the clinical success rate of candidate molecules.
AI-enhanced peptide molecule design: One of the key features of this platform is
AI-enhanced computer-aided drug design. The platform integrates artificial
intelligence-generated content algorithms, enabling the from-scratch design of novel
peptide molecules targeting specific biological targets. At the initial screening stage, the
platform is capable of producing batches of candidate molecules, which, upon in vitro
cell-based validation, demonstrated target activity at the micromolar level.
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Molecule virtual screening method based on effective activity prediction: In the
process of molecule virtual screening, we skip the traditional affinity-based screening step
and directly predict the more challenging in vitro activity. This method predicts the
activity of linear peptides or cyclic peptide compounds at specific targets by analyzing
key features such as intermolecular interactions, physicochemical properties of binding
pockets and changes in binding free energy, and further guides molecule design and
optimization through integration with in vitro activity validation and preliminary
pharmacological results. This approach not only reduces manpower, resources and time
required for affinity validation, but also lowers the resource consumption associated with
validating and optimizing high-affinity molecules.
Diversified molecule design to improve candidate success rate: New drug
development is typically characterized by long cycles, high investment and significant
risk. Leveraging peptide drug design expertise, this platform conducts multi-form
peptide molecule design based on target and binding pocket characteristics, and performs
diversified molecular screening through the platform. In candidate selection, in addition
to effective activity, druggability is also a critical factor influencing the success rate of
Phase I and Phase II clinical trials. This platform is further capable of conducting early
ADMET prediction on different forms of peptide molecules, thereby bringing forward the
assessment of druggability risks, improving the likelihood of candidates advancing from
the pre-clinical stage into clinical trials, and enhancing the overall transition efficiency of
PCCs.
Based on this platform, we have advanced multiple candidate molecules into in
vitro activity validation, significantly improving molecular design efficiency and early
development success rates for several projects, including MT1016, MT1019 and XTL3710.
As of the Latest Practicable Date, the candidate molecules of MT1016 and XTL3710 had
advanced to the PCC stage and obtained preliminary druggability evaluation data.
Oral Peptide Delivery Platform
Peptide drugs generally suffer from susceptibility to enzymatic degradation and
low intestinal absorption, leading low oral bioavailability and long-term reliance on
injections, which compromise patient adherence and convenience. The Oral Peptide
Delivery Platform we are developing is dedicated to addressing this issue. Our platform
adopts solid-dosage manufacturing processes, including solid dispersion, inclusion
complexation, dry granulation and direct compression. To promote the absorption of
protein and peptide drugs, we incorporate permeation-enhancement approaches that use
permeation enhancers and inclusion complexation to encapsulate the drug and to adjust
local pH, thereby suppressing enzymatic degradation and molecular aggregation,
stabilizing the microenvironment at the administration site, protecting the active
conformation, increasing mucosal permeability and enhancing overall formulation
stability. The platform supports two delivery routes: oral and sublingual. Oral tablets
incorporate permeation enhancers, inclusion complexation and stabilizers and are
designed to achieve therapeutically relevant systemic exposure following gastrointestinal
absorption. Sublingual tablets disintegrate in the oral cavity and deliver peptides via the
oral mucosa, enabling a faster onset while bypassing first-pass metabolism, thereby
offering flexible options to accommodate different patient needs.
Based on this platform, we have advanced the oral formulation development of five
peptide candidates (XTL3710, XTL3602, MT1013, MT1009 and MT200605), with XTL3710
and MT1013 achieving effective in vivo exposure.
Druggability Evaluation Platform
Our druggability evaluation platform is centered on animal model–based
assessments. This platform runs through the entire process of new drug development,
from target identification, hit discovery, lead generation and optimization, to the selection
of preclinical candidate (PCC) and clinical candidate (CC). Our evaluation system adopts
a phased and progressive decision-making mechanism, covering early-stage screening of
efficacy, toxicity, metabolism and physicochemical properties, IND-enabling studies such
as safety assessment, toxicology, formulation and quality control, as well as clinical-stage
validation of human efficacy, safety, and evaluation of carcinogenicity and genotoxicity.
At each stage, key go/no-go decisions are made based on the compound’s druggability,
safety and efficacy profile, ensuring scientific, risk-managed advancement of new drug
candidates.
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Multi-model evaluation framework with translational focus: Focusing on
metabolic diseases (particularly renal-related) and cardiovascular and cerebrovascular
diseases, this platform has established approximately 100 pharmacodynamic animal
evaluation models and more than 100 blood and urine biochemical testing capabilities to
support the pharmacological assessment needs of its pipeline assets. Model selection is
based on the alignment between the drug’s mechanism of action and the characteristics of
the intended indication, ensuring high relevance and translational value of the results.
Building on this, we have developed an integrated evaluation system covering key aspects
including in vitro biological studies, in vivo efficacy in disease models, safety evaluation
and DMPK. This system provides comprehensive validation support across both in vitro
and in vivo stages, facilitating a seamless data transition from animal studies to human
trials and enhancing the translational reliability of preclinical findings.
Infrastructure supporting multidimensional druggability assessment: We have
established a standardized druggability evaluation system, which includes standardized
animal facilities (SPF) and a range of research and functional platforms, covering
functional laboratories, ex vivo organ and tissue research laboratories, behavioral
pharmacology evaluation laboratories, clinical testing laboratories, and pathology
diagnostic platforms. Equipped with medical diagnostic and analytical instruments, the
system supports a wide range of assessments.
This platform has been continuously optimized and iterated to comprehensively
support the druggability evaluation of all our self-developed pipelines. All seven
clinical-stage candidates have undergone druggability evaluation via this proprietary
platform.
RESEARCH AND DEVELOPMENT
For the years ended December 31, 2024 and 2025, our R&D expenses amounted to
RMB107.0 million and RMB130.1 million, respectively. We have been focusing our
in-house R&D efforts on the development of our Core Product, MT1013. For the years
ended December 31, 2024 and 2025, we incurred R&D expenses for MT1013 of RMB66.7
million and RMB84.4 million respectively, representing 62.3% and 64.9% of our total R&D
expenses for the same period, respectively.
R&D T eam
As of the Latest Practicable Date, we had a team of 117 R&D professionals,
representing approximately 80.7% of our total staff count. Among them, over 48.7% held
doctoral or master’s degrees in fields primarily including pharmacy, pharmaceutical
sciences, chemistry, biology and biotechnology, as well as related disciplines such as
chemical engineering and public health and clinical medicine. Our core R&D personnel
consisted of eight members, who collectively possess extensive experience across the
entire drug R&D process, including discovery, pre-clinical studies, CMC development,
clinical trials and registration, with an average of approximately 19 years of experience in
the biopharmaceutical industry.
The following table sets forth a breakdown of the number of R&D team by function
as of the Latest Practicable Date:
Function of R&D team Number
CMC R&D Center ..................................... 3 7
Pre-Clinical R&D Center ................................ 1 7
Clinical R&D Center ................................... 6 3
T otal ................................................ 117
The following table sets forth the identities, positions, expertise of our eight core
R&D personnel and their involvement and contributions to the R&D activities since the
discovery of the Core Product and up to the Latest Practicable Date. All the key employees
involved in the development of the Core Product MT1013 remained employed by us
during the Track Record Period and as of the Latest Practicable Date.
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Identities Positions Expertise
Involvement and
contributions to the R&D
activities since the discovery
of the Core Product
Date of joining
our Group
Dr. Wang Bing (ˮΏ) . . Chairman of our Board
and Executive
Director
Over 20-year experience in the medical
and pharmaceutical industry
Steered key development
directions of the Core
Product
December 2019
Dr. Yu Weiping ..... Executive Director,
Senior Vice President
Over 40-year experience of drug R&D
with a doctoral degree of University
of Paris-Sud
CMC of the Core Product August 2019
Ms. Wang Xiangling
(ޛ)
1) ......
Chief Medical Officer Nearly 20-year experience of drug
R&D with education experience in
Xiangya School of Medicine and
Shantou University Medical College
Clinical trials of the Core
Product
October 2024
Dr. Wang Linyuan
(ˮ೙ధ).......
Senior Medical
Director
(2)
Over 15-year experience of drug R&D
with education experience in New
York University, and Peking
University
Clinical development of the
Core Product
August 2024
Dr. Liu Xingxin
(ᄎጳอ).......
Senior Director of API
Department
(2)
Over 10-year experience of drug R&D
with education experience in
Northwestern University, Institute of
Chemistry, Shanghai Institute of
Organic Chemistry, Chinese
Academy of Sciences, Lehigh
University and Clarkson University
Raw material process R&D
and industrial technology
transfer of the Core
Product
August 2019
Dr. Liu Yongzhen
(ޜ.......)
Director of Non-clinical
Department
(2)
Over 20-year experience of drug R&D
with education experience in China
Medical University, Shanghai Jiao
Tong University and Shanghai
University of Traditional Chinese
Medicine
Non-clinical work related to
the pharmacology,
toxicology and other
aspects of of the Core
Product
September 2023
Mr. Yu Zhi
(Яқ)........
Chief Operating Officer Over 15-year experience of drug R&D
with education experience in Bengbu
Medical University
Clinical operations
management of the Core
Product
January 22, 2024
Dr. Kong Lingna
(ࢆ.......)
Vice President of
Regulatory Affairs
Over 10-year experience of drug R&D
with education experience in Peking
Union Medical College
Registration of the Core
Product
July, 2025
Notes:
(1) Ms. Wang Xiangling focused on clinical development and the related functions. At the time of her
appointment, MT1013-II-C02 was ongoing, MT1013-II-C03 and MT1013-III-C01 was under
preparation. Given the increasing complexity of late-stage clinical trials, we consider it essential
to strengthen our clinical development leadership. Ms. Wang’s extensive experience in clinical
operations and regulatory communication enables us to enhance our capabilities in managing
large-scale clinical trials and advancing our Core Product in an efficient and compliant manner.
Prior to the joining of Ms. Wang Xiangling, the rest of R&D personnel had sufficient experience to
support the R&D of our Core Product and had been contributing to the R&D of the Core Product
throughout the process under the leadership of Dr. Wang Bing and Dr. Yu Weiping, including but
not limited to drug discovery and clinical trial management. For biographies of Dr. Wang Bing,
Dr. Yu Weiping and Ms. Wang Xiangling, please see “Directors and Senior Management”.
(2) The term “director” refers to the working title of the employee, not the member of the Board.
R&D Facilities
As of the Latest Practicable Date, our R&D activities were primarily conducted in
our headquarters Xi’an in the PRC. Our R&D facilities are equipped with advanced
equipment and workspace to facilitate the R&D activities covering basic research, drug
discovery, pharmaceutical development as well as regulatory matters.
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R&D Process
The flowchart below illustrates the key stages of our R&D process, from basic
research, drug discovery research, drug development research to NDA submission:
/g57/g3Functional Genes
/g57/g3Disease Mechanism
/g57/g3Drug Target
/g57/g3Preclinical Evaluation:
    Pharmaceutical Dr uggability Assessment
    Pharmacological Dr uggability Assessment
/g57/g3Clinical Evaluation:
    Clinical Efficacy and Side Effects Assessment
    Industrialisation Feasibility Assessment
/g57/g3Searching for Drug Candidates:
    Pharmacodynamics Evaluation
    Preliminary Toxicology Evaluation
    Preliminary Pharmacokinetics Evaluation
Basic
Research
Discovery
Research
Development
Research
New Drug
Launch
Basic Research. At the basic research stage, efforts are primarily focused on the
identification of functional genes, elucidation of disease mechanisms, and discovery of
potential drug targets, providing the biological foundation and target rationale for
subsequent drug development.
Drug Discovery Research. The drug discovery phase begins with developability assessment,
where we conduct iterative cycles of therapeutic indication evaluation, target validation,
competitor benchmarking, and risk-benefit analysis to identify promising opportunities.
During this critical stage, our early-stage R&D department of Pre-Clinical R&D team
focuses on scaffold design and optimization, systematically progressing compounds
through hit identification and hit-to-lead-to-candidate optimization. Concurrently, our
biology team of early-stage R&D department performs essential target verification along
with preliminary assessments of pharmacological activity, pharmacokinetic properties,
and toxicity profiles. This multidisciplinary approach ensures we select only the most
viable candidates for further development while mitigating potential risks early in the
process.
Drug Development Research. The subsequent drug development phase represents a
comprehensive druggability evaluation stage where drug candidates undergo extensive
preclinical and clinical assessment:
— Our preclinical evaluations include integrated druggability assessments featuring
complete pharmacological characterization, pharmacokinetic/pharmacodynamic
studies, and toxicological profiling, as well as pharmaceutical druggability
assessment covering process development, quality standard establishment, and
early formulation technology assessment.
— As drug candidates progress, we conduct clinical studies focused on administration
route/dose exploration and efficacy/safety profiling, while simultaneously
advancing industrialization research to optimize API processes, refine dosage form
manufacturing, and enhance quality standards.
Application for marketing of new drugs. If the safety and effectiveness of a drug have been
proved in clinical trials. Once the requirements for the manufacturing process, quality
control and GMP are met, we can then apply for an NDA with the regulatory authority.
Collaboration with Third Parties in R&D
We collaborate with third parties such as SMOs and CROs to conduct and support
our preclinical and clinical studies, which is in line with the general practice in the
industry. We select our SMO and CRO partners by weighing various factors, such as their
qualifications, academic and professional experience, industry reputation and service
fees.
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In terms of the involvement and contributions of each of the major SMOs and CROs
to the development of our drug candidates, the SMO partners provide a comprehensive
suite of services to assist us in implementing and managing clinical trials, including trial
preparation and trial conduct management. The preclinical CRO partners mainly provide
us with services related to preclinical toxicity and safety evaluations, such as animal
studies, of our product candidates in accordance with agreed study design and under our
supervision. The clinical CRO partners provide us with an array of services necessary for
complex clinical trials in accordance with agreed trial design and under our supervision.
We carefully supervise our SMO and CRO partners to ensure that they perform their
duties in a manner that complies with our protocols and applicable laws and protects the
data integrity.
Our cooperative relationship with SMO and CRO partners is based on specific
projects, depending on the type of services needed, we enter into service agreements
which set out detailed work scope, work plan and technical requirements, deliverables
and payment schedule. Key terms of our agreements that we typically enter into with our
SMO and CRO partners are set forth below:
Agreements with SMOs
• Services. According to China’s GCP common practice, we engage SMOs, working
together with trial sites in trial site management, including assisting in recruiting
trial participants, coordinating site staff to confirm site process compliance,
collecting clinical trial documents and maintaining data integrity at each site.
• Term. Our SMO partners are required to perform their services and complete the
clinical trial project within the prescribed time limit set out in each agreement, with
service fees settled based on actual enrollment.
• Payments. We typically make an initial payment within a specified timeframe upon
the execution of the agreement and make subsequent payments through monthly or
quarterly settlement. We generally settle payments upon receipt of deliverables at
the conclusion of project.
• Intellectual property. All clinical results, reports, publications, and related rights
and interests, including all intellectual property rights in connection with the
performance of the agreements, are owned by us.
• Confidentiality. SMOs are obligated to keep all non-public information and data
from clinical trials confidential.
• GCP compliance. We require our SMO partners to coordinate clinical trials in
accordance with GCP standards. Typically, we require the clinical research
coordinator to have GCP training experience and hold relevant certification.
Agreements with CROs
• Services. Our CRO partners are required to conduct comprehensive
implementation, management, and monitoring of clinical trials as specified in the
agreement.
• Term. Our CRO partners are required to perform their services and complete the
clinical trial project within the prescribed time limit set out in each agreement.
• Payments. We are required to make payments to CRO partners in accordance with
the payment schedule agreed by the parties.
• Intellectual property rights. All intellectual property rights arising from preclinical
and clinical trials are owned by us.
• Confidentiality. Our CRO partners are required to keep confidential all the data,
information or contents we distributed to them related to the project specified in the
agreement, and such obligation may survive the termination of the cooperation
agreement.
• GCP compliance. We require our CRO partners to conduct clinical trials in
accordance with GCP standards. Typically, we require the CRO personnel handling
our clinical trials to have GCP training experience or hold relevant certification.
We engaged in strategic R&D collaborations with a university in the U.S., which
provide us with valuable insights into industry trends and emerging technologies,
thereby enabling us to focus our current and future R&D efforts more effectively and
maintain our competitive edge. Set out are the details of the collaboration:
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• Statement of Work. This university shall conduct a pre-clinical study entitled “The
neuroprotection of MT1006 and MT2006 series compound in Huntington’s disease
mouse model”; test if a high (10 mg/kg) and a low (2.5 mg/kg) dose compound
MT200605 continue show protection on Huntington’ disease mice; and add MRI
scan and analysis to MT200605 or vehicle treated HD and WT mice.
• Intellectual Property. We acted as the sponsor and retained the sole patent rights and
future applications related to the MT1006 and MT2006 series compounds, and all
inventions developed under the research agreement shall be owned by us.
• Payment. We are responsible for paying the university in accordance with the budget
set out in the agreement.
PRODUCTION
At current stage, as all our manufactured products are investigational drugs for
clinical trial use, we arrange production schedules in accordance with clinical
development plans and outsource the manufacturing of both APIs and drug products to
third-party CDMOs.
CMC
Our CMC R&D center, comprising the CMC quality department, API department,
formulation department and analytical department, provides support throughout the
drug development process. Our CMC platform covers the key CMC development stages
for APIs, formulations and sustained-release preparations. It encompasses the core
capabilities required across the peptide drug development cycle, including process
development and optimization from the preclinical to commercial stages, comprehensive
quality studies, and technology transfer in support of regulatory submissions. Leveraging
this platform, our CMC R&D team is capable of independently conducting key activities
including API process development, formulation process development and API scale-up
at kilogram level. As of the Latest Practicable Date, our CMC team consisted of 37
members.
Collaboration with CDMO
As of the Latest Practicable Date, we had not established any manufacturing facility
for commercialization scale. We currently collaborate with industry recognized CDMOs in
China and have simultaneously commenced the construction of our Taizhou formulation
plant. Upon completion of the construction and obtaining the requisite approvals from the
relevant authorities, we plan to utilize the Taizhou formulation plant for the
commercial-scale production of MT1013 following commercialization, as well as the
pilot-scale production of our other pipeline candidates. We intend to maintain
collaboration with the CDMOs after the Taizhou formulation plant is in use, as the
production capacity of the Taizhou formulation plant may not fully satisfy the expected
commercial production demand for MT1013, and external CDMOs may also provide
additional production capacity and manufacturing flexibility for our pipeline products.
Our CDMO partners have established a set of GMP and cGMP-compliant
biopharmaceutical R&D and production system which is recognized by the CDE, FDA and
EMA. We believe it is cost-effective to engage CDMO for certain manufacturing activities
as it reduces the capital expenditure required for setting up and maintaining the necessary
production lines and allows us to optimize resource allocation to focus on the drug R&D at
current stage. We rigorously select CDMO partners in accordance with our Code of
Conduct for Procurement Operations, employing a comprehensive evaluation framework
that assesses seven key dimensions: Technology (T), Quality control and after-sales
service capabilities (Q), Responsiveness and cooperation willingness (R), Delivery
capacity (D), Cost (C), Environment (E), and Social responsibility (S) collectively forming
our TQRDCES supplier assessment methodology. To monitor and evaluate the services of
our CDMO partners, we have adopted MAH system by entering into manufacturing
agreements and quality agreements with our CDMO partners, wherein the respective
responsibilities and obligations of all parties are clearly stipulated throughout the entire
product lifecycle including manufacturing, quality testing, product release, logistics and
end-use applications, ensuring full compliance with applicable regulatory requirements.
We did not experience any product quality issues in respect of the products manufactured
by our CDMO partners during the Track Record Period.
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Salient terms of our collaboration agreement with our CDMO partners are set forth
below:
• Scope of services. The CDMO is responsible for providing services including
process development, GMP manufacturing of APIs and production of clinical trial
materials.
• Payments. We typically make an initial payment within a specified timeframe upon
the execution of the agreement. As the CDMO delivers the agreed-upon goods, we
will inspect and approve them. After approval, the CDMO will issue invoices based
on the delivered quantities. We will make the corresponding payment after
receiving the invoice.
• Intellectual property. Any new technological documents, product verification
(including process and method verification), quality standards, records, technical
achievements, and intellectual property (including patents, copyrights, and
non-patented technology) generated by the CDMO under this contract will belong
to us. This includes all written deliverables provided by the CDMO under this
agreement.
• Term. The agreement becomes effective immediately upon both parties signing and
stamping it.
• Exclusivity. The CDMO promises not to develop or manufacture similar or identical
products related to this project for themselves, nor will they sell the raw materials or
finished products to third parties.
Quality Assurance and Quality Control
In accordance with applicable pharmaceutical regulatory requirements, we have
established a Quality Assurance (QA) Department and a Quality Control (QC)
Department to oversee quality management. The QA function is responsible for: (i)
establishing, implementing and supervising our quality management system to ensure
ongoing compliance with the PRC Drug Administration Law, Good Manufacturing
Practices and other relevant regulatory requirements; (ii) managing key quality events
and independently performing core functions including product release, supplier audits,
CDMO oversight, validation activities and regulatory inspection preparedness; and (iii)
carrying out GMP training, regulatory communication, product recall and complaint
handling, as well as conducting annual product quality reviews, risk assessments and
internal audits. The QC function is responsible for: (i) developing and implementing
quality control systems to ensure that our products meet applicable legal and regulatory
requirements, industry standards and customer specifications; (ii) overseeing full-process
quality testing, including sampling and analysis of raw materials, intermediates and
finished products manufactured by third-party CDMOs; and (iii) conducting quality data
analysis and risk identification, facilitating continuous improvement, and maintaining a
traceable quality data management system.
COMMERCIALIZATION
Our Marketing Strategy
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 MT1013 in early 2028, we will implement a dual-track
commercialization approach: domestically through collaborations with third party
Contract Sales Organizations (CSOs) and internationally via license-out partnerships.
Considering the potentially significant sales cost, we have not built our internal sales
team. Instead, we plan to form cooperation with selected CSO partners to leverage their
access to a wide range of pharmacies, clinics and hospitals, to better capture the market
potential and maximize the value of our Core Product. In particular, we prioritize CSO
partners with: (i) demonstrated success in the nephrology therapeutic area, (ii)
established nephrology-focused commercialization teams, and (iii) proven capabilities in
hospital network development and coverage.
In February 2026, we entered into an agreement (the “ Agreement”) with Everest
Medicines (China) Co., Ltd. (“ Everest”), a wholly-owned subsidiary of Everest Medicines
Limited (Hong Kong Stock Code: 1952), both of which are Independent Third Parties, save
for being a Cornerstone Investor of the Company. Pursuant to the Agreement, we granted
Everest an exclusive right to sell, commercialize and promote our self-developed drug
candidate MT1013 for the treatment of CKD-SHPT in Chinese Mainland, Hong Kong,
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Macau, and Taiwan as well as Asia-Pacific (excluding Japan) (the “ T erritory ”).
Accordingly, Everest acts as an exclusive CSO responsible for the commercialization of
MT1013 for the treatment of CKD-SHPT in the Territory, while we reserved the rights to (i)
research, develop and manufacturing MT1013 globally; (ii) commercialize MT1013 for any
indications outside Territory; and (iii) commercialize MT1013 in the Territory for any
indications other than CKD-SHPT. The following sets forth the salient terms of the
Agreement.
R&D As MT1013 is our self-developed drug candidate, we retain full
responsibility for all development activities for MT1013 in the
Territory, including conducting CMC studies and pre-clinical
studies, and continuing to conduct and complete the clinical trials
for MT1013 in Chinese Mainland for CKD-SHPT;
MAH We shall be responsible for applying for, obtaining, renewing and
maintaining the marketing authorization for MT1013 in Chinese
Mainland in accordance with applicable laws, and we or our
affiliates shall act as the MAH;
IP rights We shall own all IP rights relating to MT1013 and are responsible
for the maintenance and enforcement of such IP rights, including
bringing legal actions, infringement proceedings and defending
against infringement claims;
Production We shall be responsible for manufacturing and supplying
MT1013, either by ourselves or through third parties, to Everest or
its designated distributors.
Commercialization To facilitate sales and marketing and in line with general practice
in the industry, Everest shall be entitled to handle general matters
with respect to the routine and day-to-day marketing of MT1013
in the Territory for the treatment of CKD-SHPT, including
formulating and implementing market access and reimbursement
negotiation strategies, while giving good faith consideration our
Company’s reasonable suggestions. Everest shall also prepare and
submit an annual commercialization plan for MT1013 for the
treatment of CKD-SHPT, subject to our Company’s review, and
provide periodic reports on its implementation. In addition,
Everest shall undertake annual minimum sales target with our
Company, which will be subjected to negotiation between our
Company and Everest.
Joint steering
committee (“JSC”)
A JSC shall be established to coordinate and communicate the
commercialization activities of MT1013 in the Territory for the
treatment of CKD-SHPT. The JSC shall consist of four members,
with two representatives appointed by each party;
Payment We are entitled to receive (i) an upfront payment of RMB200
million; (ii) potential regulatory and commercial milestone
payments of up to RMB1,040 million; and (iii) royalty payments
under this Agreement. As of the Latest Practicable Date, we have
received the upfront payment of RMB200 million and expect to
receive further milestone and royalty payments. Such royalty
payments are calculated on a tiered basis as a percentage of the
net sales of MT1013, with applicable rates ranging from 35% to
40%. We are not required to pay any forms of fees to Everest under
this Agreement.
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Pricing Prior to the inclusion in the NRDL, pricing of MT1013 in the
Territory will be reviewed by the JSC and agreed to by the
parties.
(1) Following the inclusion in the NRDL, the pricing and
reimbursement arrangements of MT1013 will be subject to the
pricing and reimbursement mechanisms administered by the
relevant PRC governmental authorities.
Termination The Agreement may be terminated under certain circumstances,
including if Everest fails to achieve a specified percentage of the
annual minimum sales target for three consecutive years, in which
case we have the right to terminate the Agreement.
Notes:
(1) To maximize the commercialization of MT1013 in the Territory during the term of the Agreement, we
decided to, among relevant factors, focus on the sales performance of MT1013. Accordingly, we retain (i)
the right to agree to the annual sales target which shall be part of the matters subject to mutual consent in
the annual commercialization plan, (ii) the minimum guarantee from Everest to purchase from us no less
than 60% of the annual sales target each year unless there is circumstances not attributable to them, and
(iii) (among the other termination rights either party is entitled to) a unilateral right to early terminate
the Agreement if Everest shall fail to purchase from us at least 80% of the annual sales target for three
consecutive years. If there’s any disagreements, the Company has the right to terminate the collaboration
with Everest unconditionally and unilaterally without any penalty or additional payment obligations on
our part, and following such termination, as the MAH of the Core Product would remain with our Group,
we may, depending on market conditions, continue the commercialization of the Core Product by
engaging distributors or alternative CSOs, or by our own sales team. We believe such mechanism to be
able to incentivize Everest to maximize the commercialization of the Core Product within the Territory
while at the same time preserving our right to terminate the collaboration should Everest fail to perform,
thereby protecting the interests of our Company. Our Directors confirm that any such termination would
not affect the Group’s rights in relation to the Core Product (including any commercialization rights).
We anticipate MT1013, a dual-target polypeptide agonist of CaSR and OGP , will be
competitively positioned in the marketplace in light of its multiple clinical benefits. Given
that CaSR agonists currently achieve a comprehensive control rate of only approximately
7.5%, there remains an urgent clinical need for new treatment options capable of achieving
higher target rates and reducing mortality risk. In a Phase II head-to-head comparison
with Etelcalcetide, after 26 weeks of treatment, the proportion of subjects in the MT1013
group achieving simultaneous control of iPTH, serum calcium and serum phosphorus was
approximately 2.5 times that of Etelcalcetide. Clinical results also showed its fast-acting
profile, and sustained efficacy, potential cardiovascular benefits, favorable safety and
tolerability profile, and improvements in bone mineral density and bone mineral
metabolism. In particular, upon the marketing approval of our Core Product MT1013, we
plan to adopt tailored business strategies at different stages of its commercial cycle. Prior
to its inclusion in the NRDL, we aim to increase the accessibility of MT1013 and gradually
accumulates the patient base by leveraging our future commercialization partner’s sales
network and experience and collaborating with the partner to conduct significant
promotion activities to improve market awareness and our brand recognition by
physicians and patients.
In the overseas markets, we plan to unlock the value of our assets through
commercialization collaborations with multinational corporations (MNCs), and we plan
to seek out-licensing opportunities with such MNCs for the development of our product
candidates. We plan to select such MNCs who have proven track record of
commercializing products with experience in the nephrology franchises, their local
presence including clinical access and network coverage as well as brand recognition, to
achieve market penetration and maximize commercial opportunities of our drug
products. We expect such MNCs to share the potentially significant development costs
with us and leverage their local network to facilitate various aspects of the clinical
development, such as clinical site establishment, patient enrollment, material supplies
and regulatory communications. For the overseas market, we generally plan to take a
step-wise approach and plan to formulate a more concrete plan after we commercialize
MT1013 in the PRC, to ensure we allocate our resources and focus on the most important
and imminent milestones. Save for the CSO collaboration arrangement in Asia (excluding
Japan) under the Agreement with Everest, we had not identified any specific partner for
licensing-out of our product candidates, nor had we identified any specific overseas
jurisdiction targeted under such collaboration plans, as of the Latest Practicable Date.
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Pricing
During the Track Record Period and up to the Latest Practicable Date, we had no
commercialized drugs on the market either in China or overseas. We have not formulated
any definitive pricing policy for our drug candidates yet. When our drug candidates
progress to commercialization in the future, we will determine their prices based on
various factors, such as current medical needs, our drugs’ pharmacoeconomic evaluation,
our production costs, prices of prior line treatment options, competitive landscape and
prices of competing drugs, differences in features between our drugs and competing
drugs, and health economics in the country to market in.
Our Core Product, MT1013, is expected to be launched in the PRC first, then in the
U.S. and other regions. We will determine the price of MT1013 in the PRC considering the
factors including estimated demand, production costs, affordability of patients, and the
prices of second generation CaSR agonists, such as Etelcalcetide (with the price of
USD2,684 and RMB3,640 per 30-day treatment cycle in the U.S. and China, respectively).
We will also take into consideration that MT1013 is the dual-targeting receptor agonist
polypeptide that simultaneously targets the CaSR and the OGP receptor, and has
demonstrated significant clinical benefits, as shown by clinical studies indicating a
marked improvement in the comprehensive control rate of iPTH, serum calcium and
serum phosphorus levels. We will further assess the differences in safety and efficacy and
respective benefits between MT1013 and any such potential competing drugs. In addition,
we will actively negotiate with government authorities for MT1013 to be included in the
NRDL to enhance our product affordability. However, inclusion into the NRDL is
evaluated and determined by the relevant government authorities and we may face
significant competition for successful inclusion. For more information, see “Risk Factors
— Risks Relating to Our Business and Operation — If our products are not included in or
are removed from national, provincial or other government sponsored medical insurance
programs, our business, financial condition, results of operations and prospects could be
materially and adversely affected.”
INTELLECTUAL PROPERTY
We own all intellectual property rights relating to our product candidates including
the Core Product. As of the Latest Practicable Date, we owned (i) 10 granted patents in the
PRC, three granted patents in Hong Kong, 23 granted patents overseas, and (ii) three
patent applications in the PRC, three patent applications in Hong Kong, 9 patent
applications overseas and one PCT patent application. As of the Latest Practicable Date,
with respect to our Core Product MT1013, we owned (i) four granted patents, including
one in the PRC, one in Hong Kong, one in Japan and one in Australia, and (ii) four patent
applications, including one in the U.S., one in Europe, one in Canada and one in Korea.
The following table sets forth the patents and patent applications of our Core Product as of
the Latest Practicable Date. For details, see “Appendix IV — Statutory and General
Information — Further Information About our Business. According to our PRC
Intellectual Property Legal Advisor, there is no material impediment in obtaining such
patents.
Title of Invention
Application
Number Jurisdiction Status
Expiration
Date
Patent Holder/
Applicant
Bispecific fusion polypeptide compound
(ي..........)
CN202180014524.4 PRC Granted April 20, 2041 Our Company
Bispecific fusion polypeptide compound . . . US18044668 U.S. Pending N/A Our Company
Bispecific fusion polypeptide compound
(ي..........)
HK62022059523.0 Hong Kong Granted April 20, 2041 Our Company
يJP2022-558554 Japan Granted April 20, 2041 Our Company
Bispecific fusion polypeptide compound . . . AU2021338639 Australia Granted April 20, 2041 Our Company
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Title of Invention
Application
Number Jurisdiction Status
Expiration
Date
Patent Holder/
Applicant
Bispecific fusion polypeptide compound . . . EP21865532.2 Europe Pending N/A Our Company
Bispecific fusion polypeptide compound . . . CA3194729 Canada Pending N/A Our Company
?????쬲 ?왢쳂 . . . KR1020237011659 Korea Pending N/A Our Company
As of the Latest Practicable Date, we had 32 registered trademarks in the PRC and
six registered trademarks overseas. We are also the registered owner of four domain name.
See “Risk Factors — Risks Relating to Our Intellectual Property Rights” for a description
of risks related to our intellectual property.
During the Track Record Period and up to the Latest Practicable Date, we had not
been involved in any material proceedings in respect of, and we had not received notice of
any material claims of infringement of, any intellectual property rights of third parties
that may be threatened or pending. A freedom-to-operate searches and analyses (“ FTO
Analysis”) has been conducted in the PRC and the U.S. in relation to our Core Product and
Key Products up to the Latest Practicable Date. Based on the FTO Analysis and as advised
by our PRC Intellectual Property Legal Advisor, Tian Yuan Law Firm, our Directors are of
the view that we have not infringed any valid and enforceable patents or other IP rights of
any third parties in the PRC and the U.S. The Joint Sponsors are of the view that the PRC
Intellectual Property Legal Advisor is competent to issue the FTO opinion based on its
professional qualifications and relevant track record.
SUPPLIERS AND PROCUREMENT
During the Track Record Period, our suppliers primarily consisted of (i) providers
of clinical services, including SMO, CRO and CDMO partners, (ii) providers of pre-clinical
services, and (iii) providers of administrative and operational management services.
We have implemented supplier management procedures and internal control
measures to prevent incidents such as clinical data integrity issues, serious quality issues
and interruption of supply, including (i) conducting supplier qualification and due
diligence procedures prior to engagement, including assessment of suppliers’
qualifications, compliance track record and industry reputation; (ii) disqualify and cease
further collaboration with suppliers in the event of material data authenticity or other
quality management issues; and (iii) incorporating breach and indemnification provisions
in our contracts to protect the interests of the Company.
For the years ended December 31, 2024 and 2025, the aggregate purchases
attributable to our five largest suppliers in each year during the Track Record Period
amounted to RMB31.3 million and RMB26.8 million, respectively, representing 39.5% and
27.6% of our total purchases for the respective periods. Purchases attributable to our
single largest supplier in each year amounted to RMB7.6 million and RMB8.6 million for
the same years, accounting for 9.6% and 8.9% of our total purchases for the respective
periods. We believe that we maintain stable relationships with our major suppliers.
Our suppliers are mainly CROs, CMOs, CDMOs. See “— Collaboration with Third
Parties in R&D” and “— Collaboration with CDMO” in this section for key terms of our
agreements that we typically enter into with a CRO, CMO, or CDMO partner.
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The following table sets forth details of our five largest suppliers in each year
during the Track Record Period:
Year ended December 31, 2024
Supplier Background
Products/
Services
Commencement
of business
relationship Credit terms
Purchase
amount
(RMB’000)
% of total
purchases for
the respective
year
Supplier A . . . . . . . . . A public company founded in 2000 in
China with approximately
RMB2,933 million in registered
capital that mainly engages in new
drug R&D, pharmaceutical
technology services and medical
product wholesale.
CRO services 2019 15-30 days 7,587.8 9.6%
Supplier B ......... A p rivate company founded in 2009
in China with approximately
RMB185 million in registered
capital that mainly engaged in
research and experimental
development.
CDMO
services,
CRO
services
2021 10 days 7,242.4 9.1%
Supplier C ......... A p rivate company founded in 2019
in China with USD47 million in
registered capital that mainly
engages in consulting services,
information technology services,
bio-energy technology services and
medical device circulation.
CRO services 2022 15-30 days 7,027.8 8.9%
Thousand Oaks Biologics INC*
(΅
ʮ̡) .........
A private company founded in 2017
in China with approximately
RMB49 million in registered capital
that mainly engages in
pharmaceutical manufacturing.
CDMO
services
2022 7-15 days 5,333.2 6.7%
Zhejiang Haorecruit
Pharmaceutical Technology
Co., Ltd.* (෍ᔼᖹ
ʮ̡ ) .......
A private company founded in 2021
in China with RMB10 million in
registered capital that mainly
engages in research and
experimental development.
Subject
recruitment
services
2023 10 days 4,144.3 5.2%
Total ............ 31,335.5 39.5%
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Year ended December 31, 2025
Supplier Background
Products/
Services
Commencement
of business
relationship Credit terms
Purchase
amount
(RMB’000)
% of total
purchases for
the respective
year
Supplier A ......... P lease see above. CRO services 2019 15-30 days 8,636.8 8.9%
Beijing Fengy Technology
Co., Ltd.* (ࠢ
ʮ̡) ...........
A private company founded in 2023
in China with approximately RMB5
million in registered capital that
mainly engages in technology
promotion and application
services.
Subject
recruitment
services
2024 30 days 5,152.7 5.3%
Supplier D ......... A c omprehensive Grade III Level A
hospital located in Beijing.
Participation
in clinical
trials
2021 20 days 4,744.8 4.9%
Zhongling Huizhi Technology
Service (Xi’an) Co., Ltd.*
(ਕ Гτ
ʮ̡) .........
A private company founded in 2015
in China with approximately RMB5
million in registered capital that
mainly engages in comprehensive
management services, technology
and software services,etc.
Clinical
monitoring
services
2024 30 days 4,395.0 4.5%
Tianjin Wanze Pharmacy Chain
Co., Ltd.* (ஹ
ʮ̡ ) ........
A private company founded in 2023
in China with approximately RMB5
million in registered capital that
mainly engages in retail industry.
Drug supply
services
2024 20 days 3,917.6 4.0%
Total ............ 26,846.9 27.6%
All of our five largest suppliers in each year during the Track Record Period are
independent third parties. To the best knowledge of our Directors, none of our Directors,
their respective associates or, or any Shareholder with over 5% of our issued share capital
as of the Latest Practicable Date has any interest in any of our five largest suppliers in each
year during the Track Record Period.
COMPETITION
Our industry is highly competitive and subject to significant change. While we
believe that our technology platforms, our drug candidates and our experienced
management team provide us with competitive advantages, we face potential competition
from many others working to develop therapies targeting the same indications. These
include major biopharmaceutical companies, specialty pharmaceutical and biotechnology
companies, and academic institutions, government agencies and research institutions.
Any drug candidates that we successfully develop and commercialize will compete both
with existing drugs and with any new drugs that may become available in the future. We
are committed to the development of innovative drug candidates with a focus on
metabolic diseases (particularly renal-related conditions) and cardiovascular and
cerebrovascular diseases, targeting indications such as CKD-SHPT, CKD-MBD with
Osteoporosis, CKD-SHPT not on Dialysis, Chronic Weight Management in Obese or
Overweight Populations, ACS-PCI and AIS. Our efforts to bring innovative drug to the
market for these indications face intense competition from a burgeoning landscape of
pharmaceutical companies. For more information on the competitive landscape of our
drug candidates, see “Industry Overview” in this prospectus.
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EMPLOYEES
As of the Latest Practicable Date, we had 145 full-time employees, all of whom were
based in China, and approximately 44.8% of whom held doctoral or master’s degrees. The
following table sets forth the details of our employees by function:
Function Number % of T otal
R & D.................................. 1 1 7 80.7%
Finance & Legal ......................... 6 4.1%
Others (Administrative, IP ,
Procurement & Public Affairs, etc.) ........ 2 2 15.2%
T otal ................................. 145 100%
We enter into individual employment contracts with our employees covering
matters such as salaries, bonuses, employee benefits, workplace safety, confidentiality
obligations, work product assignment clause and grounds for termination. Our employee
contracts specify that employees are obligated to strictly safeguard our commercial and
technical secrets. Additionally, any intellectual property created by employees during
their employment while performing their duties, other assigned tasks, or through the use
of our resources, funding, or technology, will belong to us. We place a high value on
recruiting and training qualified employees. We maintain high standards on selecting and
recruiting talent and provide competitive compensation packages. The remuneration
package of our employees includes salary and bonus, which are generally determined by
their performance review. We also offer share incentives and promotion opportunities to
motivate our employees. During the Track Record Period and up to the Latest Practicable
Date, we did not experience any material labor disputes or strikes that may have a
material and adverse effect on our business, financial condition or results of operations.
During the Track Record Period, we failed to pay social insurance premiums and
housing provident funds in full for and on behalf of some of our employees. See “Business
— Non-compliance” for more information.
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 in our clinical trials. We maintain
insurance for our employees in accordance with relevant PRC laws and regulations. We
believe that our insurance coverage is adequate to cover our key assets, facilities, and
liabilities. For more information, see “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.”
LAND AND PROPERTIES
Owned Land and Properties
As of the Latest Practicable Date, we owned the land use right of one land parcel in
Taizhou, the PRC (specifically on the north side of Donghai Sixth Avenue, Taizhou Bay
Economic and Technological Development Zone), with an aggregate land area of
approximately 28,397 sq.m., which is planned for potential development of production
facilities, including the construction of a formulation plant. Our PRC Legal Adviser
confirmed that, as of the Latest Practicable Date, we had obtained all relevant land use
rights certificates for this property in the PRC.
Leased Properties
As of the Latest Practicable Date, we leased four properties for office and R&D uses
in the PRC, with an aggregate GFA of approximately 3,863.54 sq.m. The following table
sets forth the details of our leased properties as of the Latest Practicable Date.
Usage Location GFA (sq.m.) Lease T erm
Office and R&D .... Xi’an, China 2,958.15 July 1, 2025 to June 30, 2027
Office .......... Beijing, China 221.5 November 1, 2023 to October 31, 2027
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Usage Location GFA (sq.m.) Lease T erm
Office and R&D .... Shanghai, China 563.89 May 1, 2026 to April 30, 2030
Office and R&D .... Suzhou, China 120.0 Up to September 4, 2026
As of the Latest Practicable Date, we had not completed the relevant property
leasing registration for two of our leased properties. See “Business — Non-compliance”
for more information.
As of December 31, 2025, none of the properties leased by us had a carrying amount
of 15% or more of our consolidated total assets. According to Chapter 5 of the Hong Kong
Listing Rules and section 6(2) of the Companies Ordinance (Exemption of Companies and
Prospectuses from Compliance with Provisions) Notice, this prospectus is exempt from
the requirements of section 342(1)(b) of the Companies (Winding up and Miscellaneous
Provisions) Ordinance to include all interests in land or buildings in a valuation report.
AWARDS AND RECOGNITIONS
The table below sets forth a summary of the major awards and recognition we
received during the Track Record Period.
Year of
Grant Award/Recognition Issuing Authority
2023 .... “2022 Shaanxi Provincial Innovative
Small and Medium-sized Enterprise”*
(2022ʕʃΆุ )
Ministry of Industry and Information
Technology of the PRC (ʕശɛ͏΍
ʷ௅)
2024 ..... Shaanxi Province “Unique and Innovative
Small and Medium-sized Enterprises in
Shaanxi Province”*
(ਖ਼ၚतอ ʕʃΆุ)
Shaanxi Province Industrial and
Information Technology Bureau*
(ʷᝂ)
2025 ..... “Third Prize in the National Finals
(Biomedicine Sector) of the 14th China
Innovation and Entrepreneurship
Competition” (ୋ 14ʕ਷௴อ௴ุɽᒄ
ᔼᖹΌ਷ᒄɧഃᆤ)
Torch High Technology Industry
Development Center, Ministry of
Industry and Information
Technology (৷Ҧ
ஔପุක೯ʕː)
ENVIRONMENTAL, SOCIAL AND GOVERNANCE REPORT
As a pharmaceutical technology company focusing on the R&D of new drugs, our
Company is committed to integrating ESG concepts into its corporate strategy and
operations, actively responding to the concerns of its stakeholders, and creating long-term
value for human health in a sustainable manner.
1. ESG Governance
The Company has established an ESG governance structure with clear
responsibilities. The members of the Board of Directors have diversified professional
knowledge in areas including medicine, biochemistry, pharmacology, biology, business
administration, economics and accounting, and possess the appropriate skills and
professional capabilities to understand and oversee the impact of ESG risks and
opportunities. They are responsible for coordinating ESG-related matters, undertaking
ESG strategic decision-making and supervisory functions, approving key matters such as
ESG strategic goals and management policies, and reviewing and publishing ESG reports,
to align with the Company’s business strategy and development goals. To support the
Board of Directors in implementing ESG-related work, the Company has established an
ESG working group comprising members from departments such as EHS and human
resources. This group is responsible for assisting in the formulation and review of the ESG
strategic framework, coordinating the advancement of the entire ESG management
process, implementing ESG objectives, data collection, performance evaluation, and
cross-departmental coordination, etc. The Board of Directors supervises the related work
of the ESG working group. In addition, the Company has established risk identification,
assessment and response mechanisms that cover environmental and social dimensions,
and fully integrates ESG factors into its daily corporate operations.
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We have adopted a board diversity policy, which sets out the objectives and
approaches to achieve and maintain diversity on the Board of Directors to enhance its
effectiveness. Our Company seeks to achieve diversity among the members of the Board
of Directors by considering a number of factors, including but not limited to gender, age,
cultural and educational background, professional experience, skills, knowledge and/or
length of service. Our Board of Directors currently comprises two female Directors and
seven male Directors, with ages ranging from 36 to 67. We attach great importance to the
expectations and demands of stakeholders and continuously improves its ESG
management structure. Currently, our Company has conducted specialized ESG training
for all employees (including directors and senior management) and holds regular
cross-departmental ESG promotion meetings to strengthen internal consensus and
executive synergy. Our Company plans to further optimize its risk identification and
assessment mechanisms after listing, enhance its risk management capabilities, and
periodically disclose ESG-related reports in accordance with regulatory requirements, to
continuously improve its ESG governance level and sustainable development
performance.
ESG Materiality Assessment and Risk Management
In accordance with the Environmental, Social and Governance Reporting Guide of
the Hong Kong Stock Exchange, and in combination with the industry’s characteristics
and the Company’s actual operating conditions, it systematically identifies ESG issues
and related risks that have a substantive impact on the business and are of concern to
stakeholders, and continuously optimises relevant management work. In terms of
material issue identification, we have identified key issues from two dimensions:
importance to sustainable development and importance to stakeholders. These issues are:
supply chain management, patents and intellectual property, and climate change, which
are incorporated into its ESG management strategy and policies.
• Supply Chain Management: At the business operations level, supply chain
disruptions or quality instability could lead to delays in the R&D of drug
candidates, impede the progress of clinical studies, and halt the production of
commercialised products, thereby affecting drug approvals and market supply.
Financially, supply disruptions or supplier compliance issues may trigger
significant expenditures such as product recalls, liability claims or compliance
rectifications, which could have a potential adverse impact on overall profitability
and financial condition. The Company incorporates supply chain management into
its ESG management and business to enhance the sustainability and risk resilience
of its supply chain.
• Patents and Intellectual Property: In terms of business operations, patent
challenges or invalidation may impede the commercialisation process of drug
candidates, resulting in R&D investments failing to yield expected returns; in terms
of financial performance, legal disputes such as patent litigation will generate high
rights protection costs; the leakage of trade secrets of core technologies will lead to
a decline in product competitiveness, affecting revenue and profit margins; in terms
of R&D investment, significant intellectual property disputes may render years of
R&D investment unrecoverable, resulting in asset impairment losses. The Company
diversifies its intellectual property risks by exploring the development of
technological diversity and open cooperation, ensuring that its technological
capabilities continue to support its business development.
• Climate Change: In terms of business operations, the potential impacts of climate
change on supply chain logistics efficiency and energy costs have been observed,
but as of now, there has been no material disruption to normal operations. At the
strategic level, the Company is actively incorporating climate factors into its
long-term planning to enhance operational resilience and seize opportunities in the
low-carbon transition. In terms of financial performance, although climate change is
classified as a highly important issue, based on current assessments, it has not yet
had a significant impact on the Company’s profitability or financial condition, and
its actual financial impact is low.
As of the Latest Practicable Date, we had not experienced any material ESG-related
risk incidents, nor had it been subject to any penalties for violating ESG-related laws and
regulations. We will continue to improve our ESG materiality assessment and risk
management mechanisms, maintain dynamic monitoring of potential risks, and ensure
continued and stable operations.
2. Environment
2.1 Environmental Management
Our Company strictly complies with national and local environmental laws and
regulations such as the Environmental Protection Law of the People’s Republic of China (ʕശ
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), and continuously optimises its environmental management
system with reference to international standard systems. In 2024 and 2025, the expenses
incurred by our Company for environmental protection and compliance were RMB78,000
and RMB50,200, respectively. As of the Latest Practicable Date, our Company had not
recorded any environmental pollution incidents. When formulating its sustainable
development goals, the Company has fully considered its current development status and
future operational trends, and has made comprehensive reference to the requirements of
international standards such as ISSB, GRI, and SASB, as well as the performance of
industry peers. Currently, its measurable targets are at an average level within the
industry. Guided by scientific emission reduction, efficient resource utilization, and
low-carbon transition, and considering our characteristics of the industry and our
Company’s actual operations, the Company has established the following environmental
management goals:
• Emission Reduction Goals: We strictly comply with national environmental
regulations, ensuring that 100% of air pollutants such as nitrogen oxides (NO
x),
sulfur dioxide (SO 2), and volatile organic compounds (VOCs) generated during its
production and operation processes are discharged in compliance with standards.
To achieve greater emission reduction benefits, our Company, using its 2024
emission data as a baseline, aims to reduce the total emission of air pollutants by 5%
by 2030.
• Greenhouse Gas Emission Reduction Goals: We have incorporated the vision of
carbon neutrality into its long-term development plan and systematically manages
Scope 1, Scope 2, and Scope 3 greenhouse gas emissions in its operations. Our
Company has set a target to reduce its greenhouse gas emission intensity by 5% by
2030, using 2024 as the baseline. On this basis, our Company will focus on
optimising its energy structure and improving energy efficiency, and is committed
to achieving carbon neutrality at the operational level by 2050.
• Waste Reduction Goals: Through measures such as promoting green procurement,
improving material utilization efficiency, and ensuring end-of-pipe compliant
disposal and resource utilization, our Company, using the generation intensity of
2024 as a baseline, aims to reduce the emission intensity of hazardous waste by 3%
by 2030; for general waste, the target for the same period is a 5% reduction.
• Energy Use Efficiency Goals: Using the energy consumption level of 2024 as a
baseline, our Company has set a target to achieve a 5% reduction in electricity
consumption by 2030 through measures including phasing out
high-energy-consumption equipment, optimizing production scheduling and
process flows, reducing no-load and standby energy consumption, raising
energy-saving awareness among all employees, and building a comprehensive
energy-saving management system.
• Water Use Efficiency Goals: Using its water consumption performance in 2024 as a
baseline, our Company has set a target to reduce total water consumption by 3% by
2030.
2.2 Emissions Management
Our Company strictly complies with laws and regulations such as the Law of the
People’s Republic of China on the Prevention and Control of Atmospheric Pollution and
the Water Pollution Prevention and Control Law of the People’s Republic of China ( ʕശ
 ), adheres to the classification standards of the National
Catalogue of Hazardous Wastes (Τ፽ ), and achieves compliant
management throughout the waste generation and transfer stage: All hazardous and
medical waste are temporarily stored in dedicated leak-proof containers. Our Company
strictly distinguishes between hazardous waste and general solid waste, and implements
end-to-end control over their classified collection, temporary storage, transfer, and
disposal. Our Company entrusts qualified third-party organizations to carry out the
transfer of hazardous waste, medical waste, and sharps. All transfer manifests are filed for
record and inspection to achieve traceable management.
2.3 Resource Use Management
Our Company actively practices the concept of green office, improves energy use
efficiency from multiple dimensions, and builds a low-carbon office environment:
• Energy-Saving Lighting and Air Conditioning Management: Our Company has
fully adopted LED energy-saving lighting systems. In addition, our Company
implements a strict air conditioning temperature control system, effectively
reducing the electricity load from air conditioning.
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• Water Conservation Management and Efficiency Improvement: Our Company has
comprehensively improved water resource utilization efficiency by promoting
water-saving appliances and strengthening employees’ water conservation
awareness. To date, no incidents of water scarcity or wastage have occurred.
• Paperless Office and Double-Sided Printing: For documents that must be printed, a
double-sided printing policy is promoted, significantly reducing paper
consumption.
• Promoting an Energy-Saving Culture: Our Company advocates for energy-saving
behaviors among employees, requires that lighting, water supply equipment, and
other electronic facilities be turned off during non-use periods.
The table below summarizes the resource use performance of our Company during
the Track Record Period:
Metrics Unit 2024 2025
Electricity Consumption ..................... k W h 310,174 388,516
Electricity Consumption Intensity ............... kWh/person 3,737.04 3,210.88
Water Consumption ........................ m 3 643 1,910
Water Consumption Intensity .................. m 3/person 7.75 15.79
2.4 Responding to Climate Change
Our Company has systematically identified the potential impacts of climate change
on its operations, including transition risks such as changes in policies and regulations,
and physical risks such as disruptions to production and the supply chain from extreme
weather events. To this end, our Company will continue to assess climate-related risks and
opportunities, ensure its operational resilience, and steadily advance its goals of peaking
carbon emissions by 2030 and achieving carbon neutrality by 2050. As of the end of the
reporting period, our Company has initially observed the potential impacts of climate
change on certain business segments, such as supply chain logistics and energy costs, but
these impacts do not yet constitute significant operational or financial risks, and the
impact on our existing assets is low.
The table below lists the relevant risks identified to date:
Risk Type Specific Impact
Physical
Risks
Acute Risks • Power outages, network disruptions or
physical damage to R&D laboratories or
data centres caused by extreme weather
events such as heavy rain
Chronic Risks • Prolonged high temperatures and heat
affecting the stability of raw materials
during transportation and storage
• Continuous increase in cooling energy
consumption costs to maintain a constant
temperature and humidity in the
laboratory environment
Transition
Risks
Policy and Legal
Changes
• Stricter requirements for laboratory waste
disposal
• Carbon regulation leading to additional
expenses for purchasing carbon
allowances and tax payments
Market and
Technology
Risks
• Low-carbon R&D methods such as green
chemistry changing traditional R&D
models
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The table below sets out the greenhouse gas (GHG) emissions of our Company
during the Track Record Period:
Metrics Unit 2024 2025
Total Greenhouse Gas Emissions (Scope 1+Scope 2) tCO 2e 174.75 219.24
Greenhouse Gas Emissions Intensity (Scope 1+ Scope 2) tCO 2e/person 2.11 1.81
Scope 1 GHG Emissions tCO2e 8.31 10.76
Scope 1 GHG Emissions Intensity tCO2e/person 0.10 0.09
Scope 2 GHG Emissions tCO2e 166.44 208.48
Scope 2 GHG Emissions Intensity tCO2e/person 2.01 1.72
Scope 3 GHG Emissions tCO2e 9,562.51 9,932.83
Category 1 tCO2e 8,433.81 7,612.02
Category 5 tCO2e 7.56 41.3
Category 6 tCO2e 1,068.29 2,215.75
Category 7 tCO2e 52.85 63.76
Scope 3 GHG Emissions Intensity tCO2e/person 115.21 82.09
Note: The calculation method for GHG emissions is based on the *Sixth Assessment Report* issued by the
Intergovernmental Panel on Climate Change (IPCC) and the *Announcement on the Release of 2022 CO 2
Emission Factors for the Power Grid* (೯б 2022ʮѓ ) issued by the
Ministry of Ecology and Environment.
3. Social
3.1 Employment
Our Company strictly complies with laws and regulations such as the Labour Law
of the People’s Republic of China () and the Labour Contract Law
of the People’s Republic of China (), has formulated internal
management systems such as the Employee Handbook, and resolutely prohibits child
labour and forced labour. It also strictly verifies the age information of applicants,
communicates fully with employees before they work overtime, and strictly controls the
duration of such overtime. As of the Latest Practicable Date, our Company had not had
any incidents of child labour or forced labour. Our Company is committed to creating a
diverse, equal, and inclusive work environment. It avoids discriminatory language and
prejudice in recruitment and explicitly states that it does not discriminate against
employees in recruitment and actual work based on age, gender, race, disability, marital
status, etc., to ensure that employees are free from harassment and illegal discrimination.
Metrics Unit 2024 2025
Total Number of Employees Person 83 121
By Gender Male Person 36 56
Female Person 47 65
By Age 30 years old and under Person 19 25
31-50 years old Person 59 89
Over 50 years old Person 5 7
3.2 Health and Safety
Our Company strictly complies with relevant laws and regulations such as the Work
Safety Law of the People’s Republic of China () and the Law
of the People’s Republic of China on the Prevention and Control of Occupational Diseases
( ). It has formulated systems such as the “Environmental,
Occupational Health and Safety Management System”, and “Management System for
Detecting Occupational Hazard Factors in the Workplace”. To protect personnel from
harm when in contact with irritating, corrosive and toxic chemical substances (such as
pyridine and hydrochloric acid), our Company equips its laboratories with compliant
workwear, boots, gloves, masks and protective eyewear. Our Company formulates an
annual safety training plan, and conducts safety training in an orderly manner. During the
Track Record Period and up to the Latest Practicable Date, the Company did not
experienced any workplace accidents, and the number of workdays lost due to
work-related injuries was 0.
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3.3 Development and Training
Our Company has established differentiated training courses for employees of
different types and from different business departments, created an online learning
platform, and offered various categories of training content. Our Company safeguards
employees’ career development paths, providing a dual-track promotion mechanism for
management and professional development for employees at different functions and
levels, allowing them to grow and advance in a fair and just environment.
Metrics Unit 2024 2025
Percentage of Trained Employees by
Gender
Male % 43 46
Female % 57 54
Percentage of Trained Employees by
Employment Category
Senior Management % 25 26
Middle Management % 34 26
General staff % 41 48
Average Hours of
Training of Employees
by Gender
Male Hours 1,546 1,771
Female Hours 1,815 1,992
Average Hours of
Training of Employees
by Category
Senior Management Hours 504 651
Middle Management Hours 471 553
General staff Hours 2,442 2,653
3.4 Clinical Trials
Our Company complies with the principles of the Declaration of Helsinki of the
World Medical Association and relevant ethical requirements, ensures the implementation
of ethical review and informed consent procedures, and protects the rights of subjects. In
terms of data protection, our Company is committed to protecting the information of trial
participants in accordance with applicable laws, regulations, and industry standards, and
properly records, processes, and preserves participants’ clinical trial data to ensure the
security and confidentiality of their data and privacy.
3.5 Animal Welfare
Our Company strictly complies with key laws and regulations concerning animal
welfare and is committed to providing experimental animals with humane care,
psychological support, and professional veterinary care. Through ethical reviews,
personnel training, and full-process compliance supervision, it ensures that every study
reflects respect and responsibility for life.
3.6 Supply Chain Management
Our Company has established a comprehensive supply chain management system
and formulated management systems such as the “Code of Conduct for Procurement
Business” and “Cross-departmental Workflow for Bidding and Tendering by Procurement
Expert Group”. We are committed to fully integrating environmental, social and
governance factors into its supplier screening process. In 2024 and 2025, our Company
collaborated with a total of 322 and 409 suppliers, respectively. Our Company always
upholds a “zero tolerance” principle and resolutely prevents any unfair competition and
corrupt practices in the procurement and supplier fulfillment processes.
3.7 Business Ethics and Anti-corruption
Our Company strictly complies with laws and regulations such as the Anti-Unfair
Competition Law of the People’s Republic of China ( )
and the Anti-Money Laundering Law of the People’s Republic of China ( ʕശɛ͏΍ձ਷
), and has formulated internal management systems such as the “Guidelines on
Business Gifts and Anti-Commercial Bribery” to urge employees to adhere to business
ethics. In 2024 and 2025, there were no concluded legal proceedings against our Company
or its employees in relation to corruption. Our Company has established a comprehensive
whistleblower protection mechanism, and is committed to strictly protecting the
confidentiality of whistleblowers’ identities and the content of their reports, and
effectively safeguarding their legal rights and interests. Our Company organizes
specialized training on professional integrity to enhance the integrity and compliance
BUSINESS
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awareness of all employees, and strengthens the internal consensus on maintaining an
atmosphere of integrity and uprightness.
IMPACT OF THE COVID-19 OUTBREAK
The outbreak of the COVID-19 and its recurrence had caused temporary disruption
to our operations to the extent that certain on-site meetings, deployment and technical
support had to be delayed or cancelled. As of the Latest Practicable Date, however,
COVID-19 had not had any material adverse impact on our R&D activities, clinical
development, daily operation, supply chain and regulatory affairs. Given that the PRC
government has substantially lifted its COVID-19 prevention and control policies since
December 2022, our Directors are of the view that it is unlikely that the COVID-19 will
have a material adverse impact on our business going forward.
LICENSES AND PERMITS
Our PRC Legal Advisor has advised that during the Track Record Period and up to
the Latest Practicable Date, we have obtained all material licenses, permits, approvals and
certificates from the relevant government authorities that are material for the business
operations of our Group. There is no material legal impediment in renewing such licenses,
permits, approvals and certificates as they expire in the future as long as we are in
compliance with applicable laws, regulations and rules.
The following table sets forth the details of our material licenses, permits and
approvals as of the Latest Practicable Date:
License/Permit Issuing Authority Holder Grant Date Expiration Date
Certificate for Utilization of Laboratory
Animals (SYXK-( ৯) 2026-009)
(Դ͜஢̙ᗇ ᇜ໮j
SYXK-(৯ ) 2026-009)..........
Shaanxi Provincial
Department of
Science and
Technology
(ኪҦஔᝂ)
The Company March 26, 2026 March 18, 2031
Notice of Approval for Clinical Drug Trial
(2025LP01688) (ࣣٝ
ᇜ໮j2025LP01688 ) ..........
NMPA Shanghai Xitaili
Biomedical Technology
Co., Ltd.* (ɪऎГइл͛
ʮ̡)
June 30, 2025 N/A
Notice of Approval for Clinical Drug Trial
(2025LP01148) (ࣣٝ
ᇜ໮j2025LP01148 ) ..........
NMPA Shanghai Xitaili
Biomedical Technology
Co., Ltd.* (ɪऎГइл͛
ʮ̡)
April 21, 2025 N/A
Notice of Approval for Clinical Drug Trial
(2025LP01314) (ࣣٝ
ᇜ໮j2025LP01314 ) .........
NMPA Xi’an Biocare Pharma Ltd.
(ࠢ
ʮ̡)
February 20,
2025
N/A
Notice of Approval for Clinical Drug Trial
(2025LP01315) (ࣣٝ
ᇜ໮j2025LP01315 ) .........
NMPA Xi’an Biocare Pharma Ltd.
(ࠢ
ʮ̡)
February 20,
2025
N/A
Approval for XTL6001 Clinical Trial for
Weight Management ...........
FDA Shanghai Xitaili
Biomedical Technology
Co., Ltd.* (ɪऎГइл͛
ʮ̡)
December 20,
2024
N/A
Approval for MT1002 Clinical Trial for
H D ....................
FDA The Company December 13,
2023
N/A
Notice of Approval for Clinical Drug Trial
(2023LP01508) (ࣣٝ
ᇜ໮j2023LP01508 ) .........
NMPA The Company July 27, 2023 N/A
Notice of Approval for Clinical Drug Trial
(2023LP01509) (ࣣٝ
ᇜ໮j2023LP01509 ) .........
NMPA The Company July 27, 2023 N/A
BUSINESS
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License/Permit Issuing Authority Holder Grant Date Expiration Date
Notice of Approval for Clinical Drug Trial
(2023LP01200) (ࣣٝ
ᇜ໮j2023LP01200 ) .........
NMPA The Company June 25, 2023 N/A
Notice of Approval for Clinical Drug Trial
(2023LP01201) (ࣣٝ
ᇜ໮j2023LP01201 ) .........
NMPA The Company June 25, 2023 N/A
Notice of Approval for Clinical Drug Trial
(2023LP01038) (ࣣٝ
ᇜ໮j2023LP01038 ) .........
NMPA The Company June 6, 2023 N/A
Notice of Approval for Clinical Drug Trial
(2023LP01039) (ࣣٝ
ᇜ໮j2023LP01039 ) .........
NMPA The Company June 6, 2023 N/A
Notice of Approval for Clinical Drug Trial
(2023LP00534) (ࣣٝ
ᇜ໮j2023LP00534 ) .........
NMPA Xi’an Biocare Pharma Ltd.
(ࠢ
ʮ̡)
March 29, 2023 N/A
Notice of Approval for Clinical Drug Trial
(2023LP00535) (ࣣٝ
ᇜ໮j2023LP00535 ) .........
NMPA Xi’an Biocare Pharma Ltd.
(ࠢ
ʮ̡)
March 29, 2023 N/A
Notice of Approval for Clinical Drug Trial
(2023LP00489) (ࣣٝ
ᇜ໮j2023LP00489 ) .........
NMPA The Company March 24, 2023 N/A
Notice of Approval for Clinical Drug Trial
(2023LP00341) (ࣣٝ
ᇜ໮j2023LP00341 ) .........
NMPA The Company March 14, 2023 N/A
Notice of Approval for Clinical Drug Trial
(2022LP01267) (ࣣٝ
ᇜ໮j2022LP01267 ) .........
NMPA The Company August 16, 2022 N/A
Notice of Approval for Clinical Drug Trial
(2021LP01920) (ࣣٝ
ᇜ໮j2021LP01920 ) .........
NMPA Xi’an Biocare Pharma Ltd.
(ࠢ
ʮ̡)
November 30,
2021
N/A
Notice of Approval for Clinical Drug Trial
(2021LP01921) (ࣣٝ
ᇜ໮j2021LP01921 ) .........
NMPA Xi’an Biocare Pharma Ltd.
(ࠢ
ʮ̡)
November 30,
2021
N/A
Notice of Approval for Clinical Drug Trial
(2021LP01020) (ࣣٝ
ᇜ໮j2021LP01020 ) .........
NMPA The Company July 6, 2021 N/A
Notice of Approval for Clinical Drug Trial
(2021LP00813) (ࣣٝ
ᇜ໮j2021LP00813 ) .........
NMPA The Company June 2, 2021 N/A
Approval for MT1013 Clinical Trial for
CKD-SHPT ................
FDA The Company March 5, 2021 N/A
Approval for MT2004 Clinical Trial for
NASH ..................
FDA Xi’an Biocare Pharma Ltd.
(ࠢ
ʮ̡)
November 12,
2019
N/A
Approval for MT1002 Clinical Trial for
ACS-PCI .................
FDA The Company March 1, 2019 N/A
BUSINESS
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License/Permit Issuing Authority Holder Grant Date Expiration Date
Fixed Pollution Source
Discharge Permit
(91320505MA228WRPXE001W)
(๕રϮ೮াΫੂ ᇜ໮j
91320505MA228WRPXE001W ) .....
N/A Micot (Suzhou)
Pharmaceutical Co., Ltd.
(ࠢ
ʮ̡)
September 8,
2023
September 7,
2028
LITIGATIONS
We are subject to legal proceedings and claims arising in the ordinary course of our
business from time to time. See “Risk Factors — Risks Relating to Our Operations — We
may become involved in lawsuits or other legal proceedings, which could adversely affect
our business, financial conditions, results of operations and reputation.” During the Track
Record and up to the Latest Practicable Date, our Directors confirmed that we were not
involved in any litigation or arbitration proceedings pending or, to the best knowledge of
our Directors, threatened against us or any of our Directors that could have a material
adverse effect on our business, results of operations or financial condition.
COMPLIANCE WITH LAWS AND REGULATIONS
During the Track Record Period and up to the Latest Practicable Date, we did not
commit any material non-compliance of the laws and regulations which individually or in
the aggregate, in the opinion of our Directors, would have a material and adverse effect on
our business, financial condition or results of operations. As advised by our PRC Legal
Advisor, during the Track Record Period and up to the Latest Practicable Date, we had
complied with the applicable PRC laws and regulations in all material respects. Our U.S.
Legal Advisor, King and Wood LLP , confirmed that it is not aware of any incompliance or
violation by any of our U.S. subsidiary of the applicable U.S. federal and state laws during
the Track Record Period and up to the Latest Practicable Date. Our Directors further
confirm that, we have complied with all applicable laws and regulations in all
jurisdictions in which we had business operations during the Track Record Period and up
to the Latest Practicable Date.
Non-compliance
Failure to make full and timely social insurance and housing provident fund
During the Track Record Period, we failed to pay social insurance premiums and
housing provident funds in full for and on behalf of some of our employees in accordance
with applicable PRC laws and regulations. The primary reason thereof is that we
determined the contribution base for social insurance and housing provident fund based
on the employees’ salaries at the time of their onboarding and by reference to local
standards, and adjustments to such contribution bases in subsequent years in line with
employees’ annual actual salaries were not duly implemented where applicable, as our
human resources staff did not fully familiarise themselves with the applicable laws and
regulations in this regard. Based on our estimate, the shortfall of our social insurance and
housing provident fund contributions during the Track Record Period amounted to
RMB0.6 million and RMB0.9 million for 2024 and 2025, respectively. Our PRC Legal
Advisor is of the view that the risk of incurring material administrative penalties issued
by the relevant government authorities is remote, provided that there are no significant
changes in current policies, regulations, local government supervision, and law
enforcement requirements related to social insurance and housing provident fund and
based on the following reasons: (i) during the Track Record Period and up to the Latest
Practicable Date, we had not received any notification from the relevant government
authorities requiring us to settle any payment shortfall; (ii) based on the Special Credit
Reports for Market Entities issued by the competent government authorities of our
Company, we had not been subject to any administrative penalties with respect to social
insurance premiums and housing provident funds; (iii) based on telephone consultations
with several relevant authorities in the principal locations where our employees are
based, such authorities typically do not proactively require enterprises to make
retrospective contributions for all employees for historical underpayments unless
prompted by employee complaints; and (iv) if any notice related to the payment of social
insurance and housing provident funds is received from government authorities in the
future, we undertake that we will make up the required amount within the stipulated
period.
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Our Directors confirm that if we receive a notice from the relevant authorities
requiring us to rectify, pay or make up social insurance and housing provident funds
within a specified period, we will promptly comply with the requirements of such notice.
In respect of our social insurance and housing provident funds contributions, we have
adopted or plan to adopt remedial measures, including: (i) we have enhanced our
compliance policy with respect to social insurance and housing provident fund
contribution in accordance with the PRC laws and regulations; (ii) we have designated our
human resources department to review and monitor the reporting and contributions of
social insurance and housing provident fund on a monthly basis; (iii) we will consult our
PRC Legal Advisor on a regular basis for advice on the relevant PRC laws and regulations
to keep us abreast of relevant regulatory development; (iv) new joiners of us are informed
the latest social insurance and housing provident laws, regulations and company policies;
and (v) we conduct regular trainings on social and housing provident laws and
regulations for our employees to enhance the awareness of compliance.
We plan to progressively adjust the contribution bases for social insurance and
housing provident fund to comply with applicable regulatory requirements. Given that
the social insurance contribution and housing provident fund base is generally subject to
annual adjustment during the certain window determined by the local authorities, we
intend to commence the rectification process during the upcoming adjustment window in
July 2026 and expect to substantially complete such adjustment within one year.
Therefore, our Directors believe that our failure to fully pay social insurance
premiums and housing provident funds will not have an adverse impact on our financial
condition and business operations.
Non-registration of leased properties
As of the Latest Practicable Date, we had not completed the relevant property leasing
registration for two of our leased properties, mainly because: (i) the agreement of one of our
properties was executed in May 2026 and we have required the landlord to cooperate with us
in completing the lease registration within six months following execution of the lease
agreement; (ii) the non-registration of the other property was due to circumstances beyond
our control, as the registration process requires the owner’s personal cooperation, and we
will continue our engagement with the owner and endeavor to complete the registration as
soon as practicable. For details of the risk associated with the unregistered lease agreements,
please refer to “Risk Factors — Risks Relating to Our Business and Industry — We are subject
to risks associated with leasing space.” According to the Urban Real Estate Administration
Law of the PRC (جand the Commercial Building Leasing
Administrative Measures (جthe relevant local governments may
require the rectification of the non-registration of lease agreements within a certain period
of time. If rectification is not made within the specified time, we may be subject to a fine
ranging from RMB1,000 to RMB10,000 for each unregistered lease agreement and the
maximum aggregate amount of fines that may be imposed due to such defects is
RMB20,000. According to our PRC Legal Advisor, under the Civil Code of the PRC ( ʕശɛ
Պ), the non-registration of the lease agreements does not affect the validity
and enforceability of the lease agreements. During the Track Record Period and up to the
Latest Practicable Date, we had not been subject to any penalties arising from the
non-registration of our lease agreement and had not experienced any dispute arising out
of, or in relation to, our leased properties. In addition, the unregistered leased properties
were solely for the office use, and we can easily find the alternative properties in
replacement.
Therefore, our Directors believe that such non-registration would not materially
and adversely affect our business operations, and will not materially impact our ability to
use the properties, as the leases remain valid, and sufficient alternative premises are
available in the market should relocation become necessary. We will continue to liaise
with the respective lessors to complete the registrations where feasible.
BUSINESS
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RISK MANAGEMENT AND INTERNAL CONTROL
We have adopted a series of risk management policies which set out a risk
management framework to identify, assess, evaluate, and monitor key risks associated
with our strategic objectives on an ongoing basis. Risks identified by management will be
analyzed based on likelihood and impact and will be properly followed up, mitigated and
rectified by our Company and reported to our Directors. Our audit committee, and
ultimately our Directors supervise the implementation of our risk management policies.
To monitor the ongoing implementation of our risk management policies and
corporate governance measures after the Listing, we have adopted or will continue to
adopt, among other things, the following risk management measures: (i) establish an
Audit Committee to review and supervise our financial reporting process and internal
control system; (ii) adopt various policies to ensure compliance with the Listing Rules,
including but not limited to aspects related to risk management, connected transactions
and information disclosure; (iii) formulate the Anti-fraud System and other institutional
documents to clarify the concepts and forms of fraud, the attribution of anti-fraud duties,
the prevention and control of fraud, the accountability for fraud, remedial measures and
penalties; (iv) provide anti-corruption and anti-bribery compliance training periodically
to our senior management and employees to enhance their knowledge and compliance
with applicable laws and regulations; and (v) attend training sessions by our Directors
and senior management in respect of the relevant requirements of the Listing Rules and
duties of directors of companies listed in Hong Kong.
Internal Control
Our Board is responsible for establishing our internal control system and reviewing
its effectiveness. We have engaged an 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 in certain aspects,
including entity-level controls, financial reporting and disclosure controls, purchase and
payment management, inventory management, fixed assets management, human
resources and payroll management and other procedures of our operations.
The Internal Control Consultant performed the Internal Control Review covering
the period from July 2024 to June 2025, identified internal control deficiencies and
provided recommendations accordingly. We have adopted the corresponding remediation
actions to improve the effectiveness of the internal control system. The Internal Control
Consultant performed a follow-up review with regard to those actions taken by us and
there are no material findings identified in the process of the follow up review. As of the
Latest Practicable Date, there were no material outstanding issues relating to our
Company’s internal control. After considering the remedial actions we have taken, our
Directors are of the view that our internal control system is adequate and effective for our
current operations.
BUSINESS
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Data Privacy Protection
During clinical development, collaboration, and operation in the PRC, we mainly
collect and process personal information of subjects based on clinical trials. The specific
content, nature of the personal information collected and processed by us are set out in the
table below:
Nature of Personal
information Content of Personal information Purpose of Collection Special Notes
Basic Personal
Information ....
Name, date of birth, gender,
ethnicity, address, personal
telephone number, email address,
etc.
Basic information that must be
provided by subjects participating
in clinical trials to ensure they
meet the eligibility criteria and
can be contacted during their
participation in the trial.
1. The basic personal information and
personal identification information
collected and processed by us as the
clinical trial Sponsor are de-identified
personal information, which cannot
directly identify or be associated with
a specific subject. Such basic
information and data are provided to
us by clinical trial institutions in the
form of subject identification codes.
2. Certain employees dispatched by us,
such as Clinical Research Associates
(CRAs) and Quality Assurance (QA)
personnel, may review and verify
subject information at the research
centers, but will not provide the
specific content of such information to
us.
3. During the clinical trial process, the
personal information collected and
processed for each clinical trial varies
according to the specific clinical trial
protocol. Therefore, the Personal
information described herein may not
be collected and processed in every
trial.
4. The personal information described
herein includes sensitive personal
information.
Personal
Identification
Information ....
ID card, Social Security card, etc. Basic information that must be
provided by subjects participating
in clinical trials to ensure they
meet the eligibility criteria and
can participate in the trial
normally.
Personal Health and
Physiological
Information ....
Records generated from medical
treatment, such as symptoms,
hospitalization records,
laboratory reports, medication
records, drug/food allergy
information, reproductive
information, past medical history,
diagnosis and treatment
information, history of present
illness, etc.; and information
related to personal physical
health status, such as height,
weight, etc.
Other Information . . Such as information regarding
sexual life.
In the process of collecting personal information, we have complied with the
principles and requirements of legality, minimum necessity, and informed consent under
applicable laws and regulations such as the Civil Code of the PRC, the Personal
Information Protection Law of the PRC, and the Good Practice for Clinical Trials of Drugs.
(1) Legality: During clinical research, we legally collect personal information of
subjects via our partners (such as clinical trial institutions). There is no
instance of collecting personal information through fraud, deception, or
inducement, nor is there any instance of obtaining personal information from
illegal channels.
(2) Minimum Necessity: The personal information collected by us is strictly
limited to materials that subjects must provide to participate in clinical
research, for the purpose of assessing whether subjects meet the eligibility
criteria for participation in clinical trials and ensuring their normal
participation in the trial. Furthermore, the basic personal information and
identification information collected by us are de-identified personal
information provided by clinical trial institutions, thereby minimizing the
specific content of personal information collected to the greatest extent
possible.
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(3) Informed Consent: When collecting personal information from subjects, we
through clinical trial institutions, informs the subjects of the specific content
of the information to be collected, the purpose and scope of its use, the rights
of the personal information subjects, and contact methods for enquiries and
exercising rights, in the form of an Informed Consent Form, and obtains
written, signed informed consent forms from the subjects.
We have strictly limited the use of collected personal information of subjects to the
purposes and scopes of related clinical trials, such as trial conduct and information
verification. Our Directors and U.S. Data Legal Advisor, Concord & Sage PC, confirm that
no new clinical trials have been initiated in the U.S. since 2023 by the Company.
Consequently, throughout the Track Record Period and up to the Latest Practicable Date,
the collection of trial subjects’ personal information has been strictly confined to
Mainland China, with no further data gathered from the U.S. As confirmed by our PRC
Data Legal Advisors, Grandall Law Firm (Shenzhen), the collection and processing of
subjects’ personal information by us during clinical development, collaboration, and
operation has complied, in all material respects, with all applicable laws and regulations
regarding data privacy and security in Mainland China during the Track Record Period
and up to the Latest Practicable Date.
From April 2019 to December 2022, we have engaged CROs to conduct clinical trials
in the U. S. for MT1002, MT1013, MT200605 and MT2004. According to our U.S. Data Legal
Advisors, they are not aware of any matter concerning the CROs’ data privacy and
protection practices under U.S. law that would be reasonably likely to have a material
adverse effect on the business, financial condition, or results of operations of our
Company.
BUSINESS
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OUR CONTROLLING SHAREHOLDERS
As of the Latest Practicable Date, Dr. Wang Bing ( ˮΏ), Dr. Wang Mei (ˮૠ) and
Xi’an Zhongrui directly held 40.56%, 6.60% and 5.48% of the interest in our Company,
respectively. Dr. Wang Bing and Dr. Wang Mei are spouses. Dr. Wang Mei and Dr. Wang
Bing held 99.00% and 1.00% of the equity interest, respectively, in Xi’an Zhongrui Zekang
Enterprise Management Consulting Co., Ltd.* (ʮ̡)
(“Zhongrui Zekang ”), which acts as the general partner of Xi’an Zhongrui. Xi’an
Zhongrui directly held 5.48% of the equity interest in the Company, such that Dr. Wang
Mei and Dr. Wang Bing are deemed to be the beneficial owners of the 5.48% equity interest
in the Company held by Xi’an Zhongrui. Therefore, Dr. Wang Bing, Dr. Wang Mei, Xi’an
Zhongrui and Zhongrui Zekang will be regarded as our Controlling Shareholders under
the Listing Rules before the Listing. Immediately upon completion of the Global Offering
(assuming the Over-allotment Option is not exercised), Dr. Wang Bing, Dr. Wang Mei,
Xi’an Zhongrui and Zhongrui Zekang will collectively be entitled to exercise
approximately 43.43% voting rights in our Company and thus remain as our Controlling
Shareholders. For background and biographical details of Dr. Wang Bing and Dr. Wang
Mei, please refer to the section headed “Directors and Senior Management — Board of
Directors” in this prospectus.
Our Controlling Shareholders have confirmed that, as of the Latest Practicable Date,
they did not have any interest in other business, apart from the business of our Company,
which competes or is likely to compete, directly or indirectly, with our business, which
would require disclosure under Rule 8.10 of the Listing Rules.
INDEPENDENCE FROM OUR CONTROLLING SHAREHOLDERS
Our Directors consider that we are capable of carrying on our business
independently of our Controlling Shareholders and their close associates after the Listing,
taking into consideration of the factors below.
Management Independence
Our Board comprises nine Directors, including two executive Directors, four non-
executive Directors and three independent non-executive Directors. We believe that our
Board as a whole, together with our senior management, is able to perform the managerial
role in our Group independently from our Controlling Shareholders for the following
considerations:
(a) each of our Directors is aware of his/her fiduciary duties as a Director which
require, among others, that he/she acts for the benefit of and in the best
interests of our Company and not allow any conflict between his/her duties as
a Director and his/her personal interests;
(b) our daily management and operation decisions are made by all our executive
Directors and senior management, all of whom have substantial experience in
the industry in which we are engaged and will be able to make business
decisions that are in the best interest of our Group. For details of the industry
experience of our senior management, please see the section headed
“Directors and Senior Management” in this prospectus;
(c) we have appointed three independent non-executive Directors, comprising
one-third of the total members of our Board, who have sufficient knowledge,
experience and competence with a view to bringing independent judgment to
the decision-making process of our Board;
(d) in the event that there is a potential conflict of interest arising out of any
transaction to be entered into between our Group and a Director and/or
his/her associate, he/she shall abstain from voting and shall not be counted
towards the quorum for the voting; and
(e) we have adopted a series of corporate governance measures to manage
conflicts of interest, if any, between our Group and our Controlling
Shareholders which would support our independent management. For
further details, please refer to the paragraph headed “Corporate Governance
Measures” in this section.
In light of the above, our Directors believe that our Company has sufficient and
effective control mechanisms to ensure that our Directors perform their respective duties
properly and safeguard the interests of our Company and our Shareholders as a whole.
RELATIONSHIP WITH OUR CONTROLLING SHAREHOLDERS
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Operational Independence
We have full rights to make all decisions on, and to carry out, our own business
operations independently. We have our own departments specializing in these respective
areas which have been in operation and are expected to continue to operate independently
from our Controlling Shareholders and their close associates. We hold all the requisite
licenses, intellectual property rights and qualifications that are material to carry on our
principal business. We also have independent access to suppliers and customers and have
sufficient capital, facilities and employees to operate our business independently from
our Controlling Shareholders and their close associates.
Based on the above, our Directors believe that we will be able to operate
independently from our Controlling Shareholders and their close associates.
Financial Independence
We have an independent financial system. We make financial decisions according to
our own business needs and neither our Controlling Shareholders nor their close
associates intervene with our use of funds. We have established an independent finance
department with a team of financial staff and an independent audit, accounting and
financial management system.
In addition, we have been and are capable of obtaining financing from third parties
without relying on any guarantee or security provided by our Controlling Shareholders or
their close associates. As of the Latest Practicable Date, our Group had no loan, advance or
guarantee provided by our Controlling Shareholders or their close associates.
Based on the above, our Directors believe that we are capable of carrying on our
business independently of and do not place undue reliance on our Controlling
Shareholders and their close associates after the Listing.
CORPORATE GOVERNANCE MEASURES
Our Directors recognize the importance of good corporate governance in protecting
our Shareholders’ interests. We have adopted the following measures to safeguard good
corporate governance standards and to avoid potential conflict of interests between our
Group and our Controlling Shareholders:
(a) where a Shareholders’ meeting is to be held for considering proposed
transactions in which our Controlling Shareholders or any of their associates
has a material interest, our Controlling Shareholders or their associate will not
vote on the relevant resolutions and shall not be counted in the quorum for the
voting;
(b) our Company has established internal control mechanisms to identify
connected transactions. Upon the Listing, if our Company enters into
connected transactions with our Controlling Shareholders or any of their
associates, our Company will comply with the applicable Listing Rules;
(c) our Board consists of a balanced composition of executive Directors,
non-executive Directors and independent non-executive Directors, with
independent non-executive Directors representing not less than one-third of
our Board to ensure that our Board is able to effectively exercise independent
judgment in its decision-making process and provide independent advice to
our Shareholders. Our independent non-executive Directors individually and
collectively possess the requisite knowledge and experience to perform their
duties. They will review whether there is any conflict of interests between our
Group and our Controlling Shareholders and provide impartial and
professional advice to protect the interests of our minority Shareholders;
(d) where our Directors reasonably request the advice of independent
professionals, such as financial advisers, the appointment of such
independent professionals will be made at our Company’s expenses; and
(e) we have appointed Halcyon Capital Limited as our compliance adviser to
provide advice and guidance to us in respect of compliance with the
applicable laws and the Listing Rules, including various requirements
relating to corporate governance.
Based on the above, our Directors believe that sufficient corporate governance
measures have been put in place to manage conflicts of interest that may arise between our
Group and our Controlling Shareholders and to protect our Shareholders’ interests as a
whole after the Listing.
RELATIONSHIP WITH OUR CONTROLLING SHAREHOLDERS
– 225 –


--- page 234 ---
This section presents certain information regarding the share capital of our
Company following the completion of the Global Offering.
IMMEDIATELY BEFORE THE GLOBAL OFFERING
As of the Latest Practicable Date, the registered share capital of our Company was
RMB5,473,719 divided into 273,685,950 Unlisted Shares with a nominal value of RMB0.02
each.
UPON COMPLETION OF THE SHARE SUBDIVISION AND THE GLOBAL
OFFERING
Immediately following the completion of the Share Subdivision the conversion of
certain Unlisted Shares into H Shares and the Global Offering, assuming that the
Over-allotment Option is not exercised, the share capital of our Company will be as
follows:
Description of Shares
Number of
Shares
Approximate
percentage of
the total
share capital
Unlisted Shares in issue .................. 51,669,250 15.58%
H Shares to be issued under the Global
Offering ............................. 58,054,400 17.50%
H Shares converted from Unlisted Shares ..... 222,016,700 66.92%
T otal ................................. 331,740,350 100%
Immediately following completion of the Global Offering and the conversion of
certain Unlisted Shares into H Shares, assuming the Over-allotment Option is fully
exercised, the issued share capital of our Company will be as follows:
Description of Shares
Number of
Shares
Approximate
percentage of
the total
share capital*
Unlisted Shares ......................... 51,669,250 15.18%
H Shares to be issued under the Global
Offering ............................. 66,762,400 19.61%
H Shares converted from Unlisted Shares ..... 222,016,700 65.21%
T otal ................................. 340,448,350 100%
* Any discrepancies in the table between the total shown and the sum of the amounts listed are due to
rounding.
SHARE CAPITAL
– 226 –


--- page 235 ---
RANKING
Upon completion of the Global Offering, we would have only one class of Shares. H
Shares and Unlisted Shares are all ordinary Shares in the share capital of our Company.
However, apart from certain qualified domestic institutional investors in the PRC, the
qualified PRC investors under the Shanghai-Hong Kong Stock Connect or the
Shenzhen-Hong Kong Stock Connect and other persons who are entitled to hold our H
Shares pursuant to relevant PRC laws and regulations or upon approvals of any
competent authorities, H Shares generally cannot be subscribed for by or traded between
legal or natural persons of the PRC. Unlisted Shares and H Shares will rank pari passu with
each other in all respects and, in particular, will rank equally for all dividends or
distributions declared, paid or made after the date of this prospectus. All dividends in
respect of the H Shares are to be paid by us in Hong Kong dollars or in the form of H
Shares.
CONVERSION OF OUR UNLISTED SHARES INTO H SHARES
Our Company has filed for a “full circulation” of 222,016,700 existing Unlisted
Shares (taking into account the Share Subdivision) into H Shares on a one-for-one basis,
and submitted the application reports, authorization documents of the shareholders of
Unlisted Shares for which an H-share “full circulation” are applied, explanation about the
compliance of share acquisition and other documents in accordance with the requirements
of the CSRC. The relevant filings of the conversion of the existing 222,016,700 Unlisted
Shares held by the existing Shareholders into H Shares on a one-for-one basis have been
completed on March 27, 2026.
Upon completion of the Global Offering, if any of our Shares are not listed or traded
on any stock exchange, the holders of our Unlisted Shares (other than those to be
converted to H Shares) may convert their Shares into H Shares provided such conversion
shall have gone through any requisite internal approval process and complied with the
regulations prescribed by the securities regulatory authorities of the State Council and the
regulations, requirements and procedures prescribed by the overseas stock exchange(s)
and have completed the required filing with the securities regulatory authorities of the
State Council, including the CSRC. The listing of such converted Shares on the Stock
Exchange will also require the approval of the Stock Exchange.
Based on the procedures for the conversion of our Unlisted Shares into H Shares as
disclosed in this section, we can apply for the listing of all or any portion of our Unlisted
Shares on the Stock Exchange as H Shares in advance of any proposed conversion to
ensure that the conversion process can be completed promptly upon notice to the Stock
Exchange and delivery of Shares for entry on the H Share register. As any listing of
additional Shares after our initial listing on the Stock Exchange is ordinarily considered
by the Stock Exchange to be a purely administrative matter, it will not require such prior
application for listing at the time of our initial listing in Hong Kong.
No class Shareholder voting is required for the listing and trading of the converted
Shares on the Stock Exchange. Any application for listing of the converted Shares on the
Stock Exchange after our initial listing is subject to prior notification by way of
announcement to inform Shareholders and the public of such proposed conversion.
After all the requisite approvals have been obtained, the following procedures will
need to be completed: the relevant Unlisted Shares will be withdrawn from the Share
register and we will re-register such Shares on our H Share register maintained in Hong
Kong and instruct the H Share Registrar to issue H Share certificates. Registration on our
H Share register will be on the condition that (a) our H Share Registrar lodges with the
Stock Exchange a letter confirming the proper entry of the relevant H Shares on the H
Share register of members and the due despatch of H Share certificates and (b) the
admission of the H Shares to trade on the Stock Exchange will comply with the Listing
Rules and the General Rules of HKSCC and the HKSCC Operational Procedures in force
from time to time. Until the converted Shares are re-registered on our H Share register,
such Shares would not be listed as H Shares.
For further details, see “Risk Factors — Risks Relating to the Global Offering —
Future sales or perceived sales of our H Shares in the public market by major Shareholders
following the Global Offering could materially and adversely affect the price of our H
Shares.”
SHARE CAPITAL
– 227 –


--- page 236 ---
TRANSFER OF SHARES ISSUED PRIOR TO THE GLOBAL OFFERING
Pursuant to the PRC Company Law, our Shares issued prior to the Listing shall not
be transferred within one year from the Listing Date. Shares transferred by our Directors
and members of the senior management each year during their term of office shall not
exceed 25% of their total respective shareholdings in our Company. The Shares that the
aforementioned persons hold in our Company cannot be transferred within one year from
the Listing Date, nor within half a year after they leave their positions as Directors or
members of the senior management in our Company.
See “Underwriting — Undertakings pursuant to the Hong Kong Underwriting
Agreement” for details of the lock-up undertakings.
SHAREHOLDERS’ GENERAL MEETING
For details of circumstances under which our Shareholders’ general meeting is
required, see “Appendix III — Summary of Articles of Association.”
PRE-IPO SHARE INCENTIVE PLAN
We adopted the Pre-IPO Share Incentive Plan, details of which are set forth in
“Appendix IV — Statutory and General Information — Further Information about our
Directors and Substantial Shareholders — Pre-IPO Share Incentive Plan.”
GENERAL MANDATES TO ISSUE SHARES, SELL AND/OR TRANSFER TREASURY
SHARES AND REPURCHASE SHARES
Subject to the completion of the Global Offering, pursuant to the Shareholders
resolutions of our Company, our Directors have been granted general unconditional
mandates to issue our Shares and sell and/or transfer our Shares out of treasury that are
held as treasury shares and repurchase our Shares. See “Appendix IV — Statutory and
General Information — Further Information about our Group — Resolutions of the
Shareholders.”
REGISTRATION OF SHARES NOT LISTED ON AN OVERSEAS STOCK EXCHANGE
According to the Guidelines for the “Full Circulation” Program for Domestic
Unlisted Shares of H-Share Listed Companies ( Hஷุ
ˏ) announced by the CSRC, the domestic shareholders of our Shares that are not
listed on the overseas stock exchange shall handle share transfer registration business in
accordance with the relevant business rules of the CSDC. Further, H-share companies
should submit the relevant status reports to the CSRC within 15 days after the transfer
registration with the CSDC of such shares involved in the application is completed.
SHARE CAPITAL
– 228 –


--- page 237 ---
THE CORNERSTONE INVESTMENT
We have entered into cornerstone investment agreements (each a “Cornerstone
Investment Agreement” , and together the “Cornerstone Investment Agreements” ) with
the cornerstone investors set out below (each a “Cornerstone Investor” , and together the
“Cornerstone Investors” ), pursuant to which the Cornerstone Investors have agreed to,
subject to certain conditions, subscribe for such number of Offer Shares (rounded down to
the nearest whole board lot of 200 H Shares) which may be purchased at the Offer Price
with an aggregate amount of HK$449.19 million (exclusive of brokerage, SFC transaction
levy, AFRC transaction levy and Stock Exchange trading fee) (the “Cornerstone
Investment”).
Pursuant to paragraph 3.2 of Practice Note 18 to the Listing Rules, at least 40% of the
total number of Offer Shares initially offered in the Global Offering must be allocated to
investors in the placing tranche (other than Cornerstone Investors). As the Company is
initially offering approximately 10% of the total number of Offer Shares in the Hong Kong
Public Offering, no more than 50% of the total number of the Offer Shares initially offered
in the Global Offering can be allocated to all Cornerstone Investors (the “Cornerstone
Investment Allocation Limit” ). Each of the Cornerstone Investors has agreed in their
respective Cornerstone Investment Agreements that the Company, the Joint Sponsors and
the Overall Coordinators shall have the right to, in their sole and absolute discretion,
adjust the allocation of the number of Offer Shares to be subscribed for by the relevant
Cornerstone Investor to ensure compliance with the Listing Rules, including the
Cornerstone Investment Allocation Limit. Accordingly, the Company, the Joint Sponsors
and the Overall Coordinators will adjust the allocation of the number of Offer Shares to be
subscribed for by the Cornerstone Investors in proportion to their respective initial
subscription amounts set out in their respective Cornerstone Investment Agreements to
ensure compliance with the Cornerstone Investment Allocation Limit, and will disclose
the number of the Offer Shares finally allocated to each of the Cornerstone Investors in the
allotment results announcement of the Company to be published on or around Tuesday,
June 23, 2026.
Assuming an Offer Price of HK$18.20, 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 24,681,000 Offer Shares, representing approximately
(i) 42.51% of the Offer Shares and 7.44% of our total issued share capital immediately upon
completion of the Global Offering (assuming the Over-allotment Option is not exercised);
and (ii) 36.97% of the Offer Shares and 7.25% of our total issued share capital immediately
upon completion of the Global Offering (assuming the Over-allotment Option is fully
exercised).
Assuming an Offer Price of HK$19.60, 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 22,918,000 Offer Shares, representing approximately
(i) 39.48% of the Offer Shares and 6.91% of our total issued share capital immediately upon
completion of the Global Offering (assuming the Over-allotment Option is not exercised);
and (ii) 34.33% of the Offer Shares and 6.73% of our total issued share capital immediately
upon completion of the Global Offering (assuming the Over-allotment Option is fully
exercised).
Assuming an Offer Price of HK$21.00, 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 21,390,200 Offer Shares, representing approximately
(i) 36.85% of the Offer Shares and 6.45% of our total issued share capital immediately upon
completion of the Global Offering (assuming the Over-allotment Option is not exercised);
and (ii) 32.04% of the Offer Shares and 6.28% of our total issued share capital immediately
upon completion of the Global Offering (assuming the Over-allotment Option is fully
exercised).
Our Company is of the view that, (i) the Cornerstone Investment 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 healthcare and biopharmaceutical sectors, as well as the active participation of
state-owned capital, the Cornerstone Investment 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 relationship of our Group or through our existing Shareholders.
CORNERSTONE INVESTORS
– 229 –


--- page 238 ---
Among the Cornerstone Investors, Qiyuan Hong Kong is ultimately controlled by
Shaanxi Provincial SASAC, it is a close associate of existing Shareholders of the Company.
Qiyuan Hong Kong has been permitted to participate in the Cornerstone Investment
pursuant to a written consent under paragraph 1C(2) of Appendix F1 to the Listing Rules
granted by the Stock Exchange. For further details of the abovementioned consent, please
refer to the section headed “Waivers from Strict Compliance with the Listing Rules and
Exemption from Strict Compliance with the Companies (Winding Up and Miscellaneous
Provisions) Ordinance” in this prospectus.
The Cornerstone Investment will form part of the International Offering and, save
as otherwise obtained consent from the Stock Exchange, the Cornerstone Investors and
their respective close associates will not subscribe for any Offer Shares under the Global
Offering other than pursuant to the Cornerstone Investment Agreements. The Offer
Shares to be subscribed for by the Cornerstone Investors will rank pari passu in all respects
with the fully paid H Shares in issue following the completion of the Global Offering and
to be listed on the Stock Exchange. The Offer Shares to be subscribed for by the
Cornerstone Investors (except for Qiyuan Hong Kong) will be counted towards the public
float of our Company under Rule 8.08 of the Listing Rules. Other than a guaranteed
allocation of the relevant Offer Shares at the Offer Price, the Cornerstone Investors do not
have any preferential rights in the Cornerstone Investment Agreements compared with
other public Shareholders. Immediately following the completion of the Global Offering,
(i) none of the Cornerstone Investors (except for Qiyuan Hong Kong) will become a
substantial shareholder of our Company; (ii) none of the Cornerstone Investors will have
any Board representation in our Company solely by virtue of its cornerstone investment;
and (iii) equity interests in our Company being beneficially owned by the three largest
public Shareholders will be less than 50% for the purpose of Rule 8.08(3) of the Listing
Rules. Each of the Cornerstone Investors are independent with each other.
The Cornerstone Investors have agreed that the Overall Coordinators 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. All Cornerstone Investors have agreed to
pay for the relevant Offer Shares that they have subscribed before dealings in the Shares
commence on the Stock Exchange. If there is over-allocation in the International Offering,
the settlement of such over-allocation may be effected through delayed delivery of the
Offer Shares to be subscribed by certain Cornerstone Investors under the Cornerstone
Investment. Where delayed delivery takes place, each Cornerstone Investor that may be
affected by such delayed delivery has agreed that it shall nevertheless pay for the relevant
Offer Shares in full before the Listing. If there is no over-allocation in the International
Offering, delayed delivery will not take place. As such, there will be no deferred
settlement of the investment amount for the Offer Shares to be subscribed by the
Cornerstone Investors pursuant to the Cornerstone Investment Agreements.
Save as disclosed above and to the best knowledge, information and belief of our
Company, (i) each of the Cornerstone Investors and its ultimate beneficial owners is an
independent third party (save for their respective interests in our Company); (ii) none of
the Cornerstone Investors is accustomed to taking instructions from our Company, the
Directors, chief executive of the Company, the Controlling Shareholders, substantial
Shareholders, existing Shareholders or any of its subsidiaries or their respective close
associates; and (iii) none of the subscription for the relevant Offer Shares by the
Cornerstone Investors is financed by our Company, the Directors, chief executive of our
Company, the Controlling Shareholders, the substantial Shareholders, existing
shareholders or any of its subsidiaries or their respective close associates for the purpose
of subscription of the Offer Shares.
Save as disclosed above and to the best knowledge of our Company and as
confirmed by each of the Cornerstone Investors, they made their own independent
decisions to enter into the Cornerstone Investment Agreements, and their subscriptions
under the Cornerstone Investment would be financed by themselves. The Cornerstone
Investors have also confirmed that all necessary approvals have been obtained with
respect to the Cornerstone Investment and that no specific approval from any stock
exchange (if relevant) or their shareholders is required for the Cornerstone Investment.
Other than a guaranteed allocation of the relevant Offer Shares at the Offer Price, the
Cornerstone Investors do not have any preferential rights in the Cornerstone Investment
Agreements compared with other public Shareholders. Other than the Cornerstone
Investment Agreements, as confirmed by each of the Cornerstone Investors, there are no
side agreements or arrangements between us and the Cornerstone Investors or any
benefit, direct or indirect, conferred on the Cornerstone Investors by virtue of or in
CORNERSTONE INVESTORS
– 230 –


--- page 239 ---
relation to the Listing, other than a guaranteed allocation of the relevant Offer Shares at
the Offer Price following the principle as set out in Chapter 4.15 of the Guide for New
Listing Applicants. To the best knowledge of the Company and as confirmed by each of
the Cornerstone Investors, their subscriptions under the Cornerstone Investment would
be financed by their own internal resources.
The total number of Offer Shares to be subscribed for by the Cornerstone Investors
under the Cornerstone Investment 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 paragraphs
headed “Structure of the Global Offering — The Hong Kong Public Offering —
Reallocation” in this prospectus. The number of Offer Shares to be acquired by each
Cornerstone Investor may be deducted on a pro rata basis in accordance with the terms of
the Cornerstone Investment Agreements to satisfy the public demands under the Hong
Kong Public Offering, after taking into account the requirements under Appendix F1 to
the Listing Rules as well as the discretion of the Overall Coordinators (for themselves and
on behalf of the International Underwriters) to exercise the Over-allotment Option.
Details of the actual number of Offer Shares to be allocated to each of the Cornerstone
Investors will be disclosed in the allotment results announcement to be issued by our
Company on or around Tuesday, June 23, 2026.
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. As such, there will be no deferred settlement of payment of the
investment amounts.
THE CORNERSTONE INVESTORS
The table below sets forth details of the Cornerstone Investment:
Based on the Offer Price of HK$18.20 (being the low-end of the indicative Offer Price
range)
Assuming the Over-allotment
Option is not exercised
Assuming the Over-allotment
Option is exercised in full
Cornerstone Investor
Investment
amount (1)
Number of
Offer Shares (2)
Approximate %
of the
Offer Shares
Approximate %
of the total
issued share
capital
immediately
upon completion
of the Global
Offering
Approximate %
of the
Offer Shares
Approximate %
of the total
issued share
capital
immediately
upon completion
of the Global
Offering
(HKD in millions)
Qiyuan Hong Kong . . 341.36 18,756,200 32.31% 5.65% 28.09% 5.51%
Everest Medicine . . . 100.00 5,494,400 9.46% 1.66% 8.23% 1.61%
Summit Capital .... 7.83 430,400 0.74% 0.13% 0.64% 0.13%
Total ......... 449.19 24,681,000 42.51% 7.44% 36.97% 7.25%
Notes:
(1) Exclusive of brokerage, the SFC transaction levy, the Stock Exchange trading fee and the AFRC
transaction levy, and are to be converted to Hong Kong dollars based on the exchange rate as disclosed in
this prospectus;
(2) Subject to rounding down to the nearest whole board lot of 200 Offer Shares. Calculated based on the
exchange rate set out in the section headed “Information about this Prospectus and the Global Offering —
Exchange Rate Conversion”.
CORNERSTONE INVESTORS
– 231 –


--- page 240 ---
Based on the Offer Price of HK$19.60 (being the mid-point of the indicative Offer Price
range)
Assuming the Over-allotment
Option is not exercised
Assuming the Over-allotment
Option is exercised in full
Cornerstone Investor
Investment
amount (1)
Number of
Offer Shares (2)
Approximate %
of the
Offer Shares
Approximate %
of the total
issued share
capital
immediately
upon completion
of the Global
Offering
Approximate %
of the
Offer Shares
Approximate %
of the total
issued share
capital
immediately
upon completion
of the Global
Offering
(HKD in millions)
Qiyuan Hong Kong . . 341.36 17,416,400 30.00% 5.25% 26.09% 5.12%
Everest Medicine . . . 100.00 5,102,200 8.79% 1.54% 7.64% 1.50%
Summit Capital .... 7.83 399,600 0.69% 0.12% 0.60% 0.12%
Total ......... 449.19 22,918,000 39.48% 6.91% 34.33% 6.73%
Notes:
(1) Exclusive of brokerage, the SFC transaction levy, the Stock Exchange trading fee and the AFRC
transaction levy, and are to be converted to Hong Kong dollars based on the exchange rate as disclosed in
this prospectus;
(2) Subject to rounding down to the nearest whole board lot of 200 Offer Shares. Calculated based on the
exchange rate set out in the section headed “Information about this Prospectus and the Global Offering —
Exchange Rate Conversion”.
Based on the Offer Price of HK$21.00 (being the high-end of the indicative Offer Price
range)
Assuming the Over-allotment
Option is not exercised
Assuming the Over-allotment
Option is exercised in full
Cornerstone Investor
Investment
amount (1)
Number of
Offer Shares (2)
Approximate %
of the
Offer Shares
Approximate %
of the total
issued share
capital
immediately
upon completion
of the Global
Offering
Approximate %
of the
Offer Shares
Approximate %
of the total
issued share
capital
immediately
upon completion
of the Global
Offering
(HKD in millions)
Qiyuan Hong Kong . . 341.36 16,255,400 28.00% 4.90% 24.35% 4.77%
Everest Medicine . . . 100.00 4,761,800 8.20% 1.44% 7.13% 1.40%
Summit Capital .... 7.83 373,000 0.64% 0.11% 0.56% 0.11%
Total ......... 449.19 21,390,200 36.85% 6.45% 32.04% 6.28%
Notes:
(1) Exclusive of brokerage, the SFC transaction levy, the Stock Exchange trading fee and the AFRC
transaction levy, and are to be converted to Hong Kong dollars based on the exchange rate as disclosed in
this prospectus;
(2) Subject to rounding down to the nearest whole board lot of 200 Offer Shares. Calculated based on the
exchange rate set out in the section headed “Information about this Prospectus and the Global Offering
Exchange Rate Conversion”.
The information about our Cornerstone Investors set forth below has been provided
by the Cornerstone Investors in connection with the Cornerstone Investment.
CORNERSTONE INVESTORS
– 232 –


--- page 241 ---
Qiyuan Hong Kong
Qiyuan Hong Kong is a limited company incorporated under the laws of Hong
Kong, which is directly and wholly owned by Shaanxi Qiyuan Gaotou Enterprise
Management Partnership (Limited Partnership) (Υྫ)
(“Qiyuan Gaotou”). The general partner of Qiyuan Gaotou is Shaanxi Qinchuang Qiyuan
Private Equity Fund Management Co., Ltd. (ʮ̡ ), holding
approximately 0.03% of the partnership interest, which is ultimately controlled by
Shaanxi Provincial SASAC.
As of the Latest Practicable Date, Qiyuan Gaotou has two limited partners,
comprising (i) Shaanxi Provincial Science and Technology Innovation Fund of Funds
Partnership (Limited Partnership) (Υྫ), which
holds approximately 83.31% of the partnership interest in Qiyuan Gaotou and is
ultimately controlled by Shaanxi Provincial SASAC and Shaanxi Provincial Department of
Finance; and (ii) Xi’an Xigaotou Zhiyuan Investment Fund Partnership (Limited
Partnership) (Υྫ), which holds approximately
16.66% of the partnership interest in Qiyuan Gaotou and is ultimately controlled by Xi’an
High-tech Industries Development Zone Administration Committee.
As Qiyuan Hong Kong is ultimately controlled by government bodies of Shaanxi
Province, it is a close associate of existing Shareholders of the Company. The Company has
sought, and the Stock Exchange has given, a consent under paragraph 1C(2) of Appendix
F1 to the Listing Rules to permit Qiyuan Hong Kong to participate in the Global Offering
as cornerstone investors subject to certain conditions. For further details of the
abovementioned consent, please refer to the section headed “Waivers from Strict
Compliance with the Listing Rules and Exemption from Strict Compliance with the
Companies (Winding Up and Miscellaneous Provisions) Ordinance” in this prospectus.
Everest Medicines Limited
Everest Medicines Limited ( “Everest Medicine” ) is a limited company incorporated
under the laws of Cayman Islands and listed on the Stock Exchange (stock code: 1952.HK).
The Controlling Shareholder of Everest Medicine is CBC Group which mainly comprises
C-Bridge Healthcare Fund II, L.P ., C-Bridge Investment Everest Limited, C-Bridge II
Investment Eight Limited, C-Bridge Healthcare Fund IV , L.P ., C-Bridge IV Investment Two
Limited, C-Bridge IV Investment Nine Limited, C-Bridge Capital Investment
Management, Ltd., CBC Group Investment Management, Ltd., C-Bridge Joint Value
Creation Limited and Everest Management Holding Co., Ltd. The aforementioned entities
are directly and indirectly controlled by Nova Aqua Limited, the entire interest of which is
held by Vistra Trust (Singapore) Pte. Limited as trustee for a trust established by Mr. Wei
Fu (as settlor) for the benefit of Mr. Wei Fu and his family. Everest Medicines is a fully
integrated biopharmaceutical company spanning discovery, licensing, clinical
development, manufacturing, and commercialization of differentiated therapies
addressing significant unmet medical needs.
Summit Capital Limited
Summit Capital Limited (ʮ̡) (“Summit Capital”) is a limited
company incorporated under the laws of Hong Kong, 40% of which is held by Hong Kong
Fengming Investment Management Co., Limited (ʮ̡ ) (“Fengming
Investment ”), and the remaining 24%, 18% and 18% interests are held by three
independent individuals respectively. Fengming Investment was founded and is
ultimately controlled by Dr. CHOI Siu Wai ( ᇹˇਃ), Vice President of the Hong Kong
Biopharmaceutical Innovation Association (ᔼᖹ௴อ՘ึ) who holds 55%
interest in Fengming Investment. The remaining 33% and 12% interests in Fengming
Investment are respectively held by Mr. Lei Duo ( ཤε) and Mr.ZHANG YuXiao (ᔅ),
who are independent third parties. Summit Capital is currently focused on equity
investments in the biopharmaceutical and hard technology sectors.
CORNERSTONE INVESTORS
– 233 –


--- page 242 ---
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 our Company and the
Overall Coordinators (for themselves and on behalf of the Underwriters);
(c) the Listing Committee of the Stock Exchange having granted the listing of,
and permission to deal in, the H Shares (including the Offer Shares under the
Cornerstone Investment as well as other applicable waivers and approvals
(including those in connection with the subscription by the Cornerstone
Investors of the Offer Shares)) and such approval, permission or waiver
having not been revoked prior to the commencement of dealings in the H
Shares on the Stock Exchange;
(d) the CSRC having accepted the CSRC filings and published the filing results in
respect of the CSRC filings on its website, and such notice of acceptance
and/or filing results published not having otherwise been rejected,
withdrawn, revoked or invalidated prior to the commencement of dealings in
the H Shares on the Stock Exchange;
(e) no laws 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
(f) the representations, warranties, undertakings, acknowledgements and
confirmations of the Cornerstone Investors under the respective Cornerstone
Investment Agreements are (as of the date of the Cornerstone Investment
Agreements) and will be (as of the Listing Date) accurate, true and complete in
all respects and not misleading or deceptive and that there is no breach of any
of the Cornerstone Investment Agreements on the part of the respective
Cornerstone Investors.
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 Sponsors and the Overall Coordinators, it will not,
whether directly or indirectly, at any time during the period of six months from and
including 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
– 234 –


--- page 243 ---
SUBSTANTIAL SHAREHOLDERS
So far as our Directors are aware, immediately following the completion of the
Global Offering and assuming the Over-Allotment Option is not exercised, the following
persons will have interests and/or short positions in the Shares or underlying shares of
our Company which would fall to be disclosed pursuant to 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 nominal value of any class of our share capital carrying rights to vote in all
circumstances at general meetings of our Company:
As of the Latest Practicable Date without
taking into account the Share Subdivision
Immediately following the completion of the Share
Subdivision and the Global Offering (1)
Name of Shareholder Nature of Interest
Number of
Shares
Description
of Shares
Approximate
percentage of
shareholding
in our total
share capital
Number of
Shares
Description
of Shares
Approximate
percentage of
shareholding
in the
relevant class
of Shares
Approximate
percentage of
shareholding
in our total
share
capital
(1)
Dr. Wang Bing (2)(3) ....... Beneficial owner;
Interest of spouse
2,881,201 Unlisted
Shares
52.64% 99,660,050
44,400,000
H Shares
Unlisted
Shares
35.58%
85.93%
43.43%
Dr. Wang Mei
(2)(3) ....... Beneficial owner;
Interest of spouse;
Interest in controlled
corporations
2,881,201 Unlisted
Shares
52.64% 99,660,050
44,400,000
H Shares
Unlisted
Shares
35.58%
85.93%
43.43%
The People’s Government of
Shaanxi Province
(4) ......
Interest in controlled
corporations
476,179 Unlisted
Shares
8.71% 35,295,900 H Shares 12.60% 12.82%
7,269,250 Unlisted
Shares
14.07%
Junying Growth (4) ....... Beneficial owner 79,647 Unlisted
Shares
1.46% 3,982,350 H Shares 1.42% 1.20%
Listing Reserve Fund (4) ..... Beneficial owner 72,635 Unlisted
Shares
1.33% 3,631,750 H Shares 1.30% 1.09%
Junying Jiacheng (4) ....... Beneficial owner 40,353 Unlisted
Shares
0.74% 2,017,650 H Shares 0.72% 0.61%
Xi’an Huiyu (4) ......... Beneficial owner 18,159 Unlisted
Shares
0.33% 907,950 H Shares 0.32% 0.27%
Shaanxi Innovation Relay (4) . . . Beneficial owner 83,077 Unlisted
Shares
1.52% 4,153,850 Unlisted
Shares
8.04% 1.25%
Shaanxi Jingang (4) ....... Beneficial owner 62,308 Unlisted
Shares
1.14% 3,115,400 Unlisted
Shares
6.03% 0.94%
New Materials Fund (4) ..... Beneficial owner 120,000 Unlisted
Shares
2.19% 6,000,000 H Shares 2.14% 1.81%
Qiyuan Hong Kong (4)(5) ..... Beneficial owner – – – 18,756,200 H Shares 6.69% 5.65%
Suzhou Mainiv ........ Beneficial owner 546,667 Unlisted
Shares
9.99% 27,333,350 H Shares 9.76% 8.24%
Beta Achieve Limited
(ʮ̡)
(“Beta Achieve”) (4) ......
Beneficial owner 354,667 Unlisted
Shares
6.48% 17,733,350 H Shares 6.33% 5.35%
Northern Light Venture Fund V ,
L.P . (“NLVF”)(4) .......
Interest in controlled
corporations
354,667 Unlisted
Shares
6.48% 17,733,350 H Shares 6.33% 5.35%
Northern Light Partners V , L.P .
(“NL Partners”) (4) ......
Interest in controlled
corporations
354,667 Unlisted
Shares
6.48% 17,733,350 H Shares 6.33% 5.35%
Northern Light Venture Capital V ,
Ltd. (4) ...........
Interest in controlled
corporations
354,667 Unlisted
Shares
6.48% 17,733,350 H Shares 6.33% 5.35%
Mr. Deng Feng (4) ........ Interest in controlled
corporations
354,667 Unlisted
Shares
6.48% 17,733,350 H Shares 6.33% 5.35%
SUBSTANTIAL SHAREHOLDERS
– 235 –


--- page 244 ---
Notes:
(L) All the interests stated are long positions.
(1) The calculation is based on the completion of the Share Subdivision and the assumption that (i)
the Over-Allotment Option is not exercised, (ii) the 222,016,700 Unlisted Shares (taking into
account the Share Subdivision) will be converted into H Shares, and (iii) the total number of the
Shares in issue will be 331,740,350 H Shares immediately after completion of the Global Offering.
(2) Immediately following the completion of the Global Offering, (assuming the Over-allotment
Option is not exercised and taking into account the Share Subdivision), Xi’an Zhongrui shall
directly hold 4.52% of the interest in our Company. Dr. Wang Mei has control over Xi’an Zhongrui
Zekang Enterprise Management Consulting Co., Ltd.* (ʮ̡)
(“Zhongrui Zekang”), and Zhongrui Zekang is the general partner of Xi’an Zhongrui.
Accordingly, Xi’an Zhongrui is controlled indirectly by Dr. Wang Mei. By virtue of the SFO, Dr.
Wang Mei is deemed to be interested in the Shares held by Xi’an Zhongrui.
(3) Dr. Wang Bing and Dr. Wang Mei are spouses. Accordingly, Dr. Wang Bing and Dr. Wang Mei are
deemed to be interested in the Shares held by each other under the SFO.
(4) Each of Junying Growth, Listing Reserve Fund, Junying Jiacheng, Xi’an Huiyu, Shaanxi
Innovation Relay, Shaanxi Jingang and New Materials Fund are ultimately controlled by the
People’s Government of Shaanxi Province . Qiyuan Hong Kong, one of our Cornerstone Investors,
is also ultimately controlled by Shaanxi Provincial SASAC. Therefore, the People’s Government
of Shaanxi Province is deemed to be interested in the Shares held by Junying Growth, Listing
Reserve Fund, Junying Jiacheng, Xi’an Huiyu, Shaanxi Innovation Relay, Shaanxi Jingang, New
Materials Fund and Qiyuan Hong Kong.
(5) Immediately following the completion of the Global Offering (assuming the Over-allotment
Option is not exercised), Qiyuan Hong Kong, as a Cornerstone Investor, will subscribe for
18,756,200 Offer Shares at the indicative Offer Price of HK$18.20 (being the low end of the
indicative Offer Price range). For further details, please refer to the section headed “Cornerstone
Investors” in this prospectus.
(6) As of the Latest Practicable Date, Beta Achieve Limited (ʮ̡)“Beta Achieve”) was held
as to 91.67% by NLVF. None of the other shareholders of Beta Achieve held more than 30% of the
shareholding interest in Beta Achieve. NLVF is an exempted limited partnership established in
the Cayman Islands, whose general partner is NL Partners. NL Partners is an exempted limited
partnership established in the Cayman Islands, whose general partner is Northern Light Venture
Capital V , Ltd., a company controlled by Mr. Deng Feng, an independent third party to our
Company. Therefore, each of NLVF, NL Partners, Northern Light Venture Capital V , Ltd. and Mr.
Deng Feng is deemed to be interested in the Shares held by Beta Achieve.
For details of the substantial shareholders who will be, directly or indirectly,
interested in 10% or more of the value of any class of Shares carrying rights to vote in all
circumstances at general meetings of any member of our Group, see “Statutory and
General Information — Further Information about our Directors and Substantial
Shareholders — Disclosure of Interests” in Appendix IV to this Prospectus.
Save as disclosed herein, our Directors are not aware of any persons who will,
immediately following completion of the Global Offering (assuming the Over-Allotment
Option is not exercised), have interests and/or short positions in Shares or underlying
shares which would fall to be disclosed 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 nominal
value of any class of our share capital carrying rights to vote in all circumstances at
general meetings of our Company or any other member of our Group.
SUBSTANTIAL SHAREHOLDERS
– 236 –


--- page 245 ---
DIRECTORS
Upon Listing, our Board will consist of nine Directors, including two executive
Directors, four non-executive Directors and three independent non-executive Directors.
Our Directors serve a term of three years and may be re-elected for successive
reappointments.
The following table sets forth certain information about our Directors:
Name Age Position Responsibilities
Date of
the first
appointment
as a director
Date of
joining our
Group
Relationship(s)
with other
Directors and
senior
management
Dr. Wang Bing
(ˮΏ) ......
55 Chairman of our
Board, Chief
Executive Officer,
Executive Director
Responsible for the overall
strategic planning of our
Group and business
operations and making
key business and
operational decisions of
our Group
December
2020
December
2019
Spouse of
Dr. Wang Mei
Dr. Yu Weiping . . 67 Executive Director,
Senior Vice
President
Responsible for the strategic
planning, overseeing the
CMC activities and the
overall operation
management of our Group
August 2019 July 2017 Nil
Dr. Wang Mei
(ˮૠ) ......
52 Non-executive
Director
Responsible for
participating in major
decisions on our Group’s
operations and
development
August 2019 August 2019 Spouse of
Dr. Wang Bing
Mr. You Xiangdong
(؇.....)
62 Non-executive
Director
Responsible for
participating in major
decisions on our Group’s
operations and
development
August 2025 August 2025 Nil
Dr. Song Gaoguang
(҂৷ᄿ) .....
42 Non-executive
Director
Responsible for
participating in major
decisions on our Group’s
operations and
development
July 2021 July 2021 Nil
Dr. Wang Nayi
(❙) .....
36 Non-executive
Director
Responsible for
participating in major
decisions on our Group’s
operations and
development
August 2025 August 2025 Nil
Dr. Xiangli Liuxu
(Ԣʬᚃ) ....
62 Independent
Non-executive
Director; Lead
Independent
Non-executive
Director
Responsible for supervising
and offering independent
judgment to the Board
Listing Date September
2025, with
effect from
the Listing
Date
Nil
Mr. Zhang
Wenqiang
(ੵ˖੶) .....
41 Independent
Non-executive
Director
Responsible for supervising
and offering independent
judgment to the Board
Listing Date September
2025, with
effect from
the Listing
Date
Nil
Mr. Wang Kaifeng
(ࢤ.....)
44 Independent
Non-executive
Director
Responsible for supervising
and offering independent
judgment to the Board
Listing Date September
2025, with
effect from
the Listing
Date
Nil
Executive Directors
Dr. Wang Bing (ˮΏ) , aged 55, has served as Director, Chief Executive Officer and
Chairman of the Board since December 2020. He is primarily responsible for overseeing
the strategic planning, business direction and daily operations and management of our
group.
DIRECTORS AND SENIOR MANAGEMENT
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--- page 246 ---
Dr. Wang also holds multiple directorships and management positions across our
subsidiaries, including (i) executive director at Micot (Suzhou) Technology Co., Ltd.* ( ௥
ʮ̡) since August 2020, a company principally engaged in medical
research and experimental development; (ii) executive director and general manager at
Micot (Suzhou) Pharmaceutical Co., Ltd.* (ʮ̡) since August
2022; (iii) executive Director and general manager at Shanghai Xitaili Biomedical
Technology Co., Ltd.* (ʮ̡ ), a biotechnology company
focusing on the research, development and application of innovative biopharmaceutical
technologies since November 2022; and (iv) director and manager at Micot (Taizhou)
Pharmaceutical Technology Co., Ltd.* (ʮ̡) which is
principally engaged in medical research and experimental development, pharmaceutical
technology development and related technical services since May 2025. In these roles, he
has been primarily responsible for overseeing the management of pharmaceutical R&D as
well as the related operational activities.
Dr. Wang is a sophisticated and resourceful veteran in China’s biotech industry with
scientific, academic and business acumen. Dr. Wang has over 20 years of experience in the
medical and pharmaceutical industry. From July 1994 to July 2001, he worked at Xi’an
Medical University* (ɽኪ) as a teaching assistant. During his tenure at Xi’an
Jiaotong University* ( Гτʹஷɽኪ) as a professor from August 2001 to December 2019, he
dedicated himself to medical teaching and research.
Dr. Wang obtained a Bachelor of Clinical Medicine degree from Xi’an Medical
University* (ɽኪ) in July 1994. He obtained a master’s degree in Pathology from
Xi’an Jiaotong University* ( Гτʹஷɽኪ) in July 1999. He further obtained a doctoral
degree in Pharmacology from Xi’an Jiaotong University* ( Гτʹஷɽኪ) in November
2007.
Dr. Wang was awarded the title of “Xi’an High-tech Zone Investment Promotion
Ambassador (2023-2024)” by the Administrative Committee of Xi’an High-tech Zone* ( Г
τ̹৷อਜ၍։ึ) in January 2023. He was also conferred the title of “Hard Technology
Innovation Talent of Xi’an High-tech Zone” by the Working Committee of Xi’an High-tech
Zone* (Гτ̹৷อਜʈ։). In June 2021, Dr. Wang received the title of “Entrepreneurial
Leader (Leading)” under the “2021 Suzhou High-tech Zone Science and Technology
Innovation and Entrepreneurship Leading Talents” program, awarded by the Working
Committee and Administrative Committee of Suzhou National High-tech Zone* (࢕
৷อਜʈ։ึʿ၍։ึ). Additionally, he was honored with the title of “Sanqin Talent”* ( ɧ
ॢɛʑ) by the Organization Department of the Shaanxi Provincial Party Committee* ( ʕ΍
։ଡ଼ᔌ௅) and the Shaanxi Provincial Department of Finance* (ᝂ) in
August 2012.
Dr. Wang was a vice chairman, manager and supervisor of certain companies
established in the PRC below prior to their dissolution/revocation.
Name of the company
Principal
business
Reasons for
the dissolution/
revocation
Date of
dissolution/
revocation Position
Xi’an Puren Biotechnology
Engineering Co., Ltd.*
(ʈ೻
ப΂ʮ̡)..........
Research and
experimental
development
Revocation of
business license
December 11, 2013 Vice Chairman,
Manager
Xi’an Hiers Biomedical
Technology Co., Ltd.*
(Ҧ
ப΂ʮ̡)..........
Research and
experimental
development
Revocation of
business license
June 22, 2021 Supervisor
Xi’an Puren Biotechnology Engineering Co., Ltd.* (ப΂ʮ̡ )
(“Xi’an Puren”) was a company principally engaged in bioengineering technology. Xi’an
Hiers Biomedical Technology Co., Ltd.* (ப΂ʮ̡ ) (“Xi’an
Hiers”) was a company principally engaged in the research, development, technical
consultancy and sale of biomedicine, medical devices, medical diagnostic products,
cosmetics and other biotechnology and healthcare-related products (excluding
pharmaceuticals).
DIRECTORS AND SENIOR MANAGEMENT
– 238 –


--- page 247 ---
As shown in the Administration of Industry and Commerce (AIC), the business
licences of Xi’an Puren and Xi’an Hiers were revoked solely due to their failure to
complete the requisite annual inspection, and such revocations were administrative in
nature. Such failure was attributable to the fact that neither entity had commenced any
actual business operations, acquired any assets, or incurred any liabilities or obligations
following their incorporation, which resulted in the annual inspection filings not being
completed within the prescribed timeframes. Other than the foregoing administrative
matters, none of the two entities was involved in any non-compliance incident prior to
their respective dissolution or licence revocation.
Our PRC Legal Advisers have further confirmed that, save for the failure to
complete the annual inspection leading to the revocation of their business licences, Xi’an
Puren and Xi’an Hiers had fully complied with all applicable PRC laws and regulations
before revocation. In particular, no violations relating to product quality, operational
compliance, taxation, employee matters or any other regulatory issues were identified
through public records searches or internal compliance enquiries.
To the best knowledge, information and belief of Dr. Wang, he confirmed that (i)
there was no wrongful act on his part leading to the dissolution/revocation of the above
companies; (ii) he is not aware of any actual or potential claim that has been or will be
made against him as a result of the dissolution/revocation of the above companies; (iii) no
misconduct or misfeasance has been involved in the dissolution/revocation of the above
companies; (iv) the above companies were solvent immediately prior to
dissolution/revocation (as the case may be); and (v) the deregistration or the revocation of
business license of the above companies had not resulted in any liability or obligation
imposed against him.
Dr. Yu Weiping, aged 67, is an executive Director, our senior vice president. He is
primarily responsible for the strategic planning, overseeing the CMC activities and
overall operation management of our Group. Dr. Yu was first appointed as an executive
Director and senior vice president in August 2019 and served until now.
Dr. Yu has over 40 years of experience in pharmaceutical research, development and
executive management. Dr. Yu served as Senior Director of Product and Process
Development at Celsion Corporation, USA, a U.S.-based biopharmaceutical company
principally engaged in the R&D of oncology therapeutics. From September 2010 to June
2014, Dr. Yu served as Vice President of research and subsequently from June 2014 to June
2017, he held the position of Chief Executive Officer and President in Lipont
Pharmaceuticals (Canada), a biopharmaceutical company engaged in the research,
development and production of pharmaceutical products.
Dr. Yu obtained a bachelor’s degree from Shanghai University of Traditional
Chinese Medicine* (ɪऎʕᔼᖹɽኪ) from 1978 to 1982. He obtained a master’s degree
from Shanghai Institute of Pharmaceutical Industry* (Ӻ৫) from 1982 to
1984. He further obtained a doctoral degree from University of Paris-Sud from 1987 to
1990.
Non-executive Directors
Dr. Wang Mei (ˮૠ), aged 52, has served as our non-executive Director since
August 2019. Dr. Wang is primarily responsible in formulating major decisions regarding
our Group’s operations and development.
Dr. Wang possesses over 30 years of expertise and in-depth engagement in the
medical and academic arenas. From July 1994 to September 1996, she worked at Xi’an
Medical University* (ɽኪ) as a teacher in the Physiology Teaching and Research
Section, where she was engaged in physiology teaching and basic medical research. Since
November 2002, Dr. Wang has been serving as a Chief Physician in the Department of
Dermatology at the Second Affiliated Hospital of Xi’an Jiaotong University* ( Гτʹஷɽኪ
᙮ᔼ৫), dedicated to clinical diagnosis and treatment in dermatology, as well as
medical research and academic promotion in related fields.
Dr. Wang obtained a bachelor’s degree in Clinical Medicine from Xi’an Medical
University* (ɽኪ) from September 1989 to July 1994. She obtained a master’s
degree in Oncology from Xi’an Medical University* (ɽኪ) from September 1996
to July 1999. She further obtained a doctoral degree in Dermatology from Xi’an Jiaotong
University* (Гτʹஷɽኪ) from September 1999 to November 2002.
DIRECTORS AND SENIOR MANAGEMENT
– 239 –


--- page 248 ---
Dr. Wang was awarded the First Prize of Shaanxi Provincial Patent by the People’s
Government of Shaanxi Province* (ִ݁She was also conferred with the
Second Prize of Shaanxi Provincial Science and Technology Progress (as the second
completed person) by the People’s Government of Shaanxi Province* (ִ݁.)
Dr. Wang was a supervisor and legal representative of certain companies
established in the PRC below prior to their dissolution/revocation.
Name of the company Principal business
Reasons for
the dissolution/
revocation
Date of
dissolution/
revocation Position
Xi’an Puren .......... Research and
experimental
development
Revocation of
business license
December 11, 2013 Supervisor
Xi’an Hiers ........... Research and
experimental
development
Revocation of
business license
June 22, 2021 Legal
Representative
To the best knowledge, information and belief of Dr. Wang, she confirmed that (i)
there was no wrongful act on her part leading to the dissolution/revocation of the above
companies; (ii) she is not aware of any actual or potential claim that has been or will be
made against her as a result of the dissolution/revocation of the above companies; (iii) no
misconduct or misfeasance has been involved in the dissolution/revocation of the above
companies; (iv) the above companies were solvent immediately prior to
dissolution/revocation (as the case may be); and (v) the deregistration or the revocation of
business license of the above companies had not resulted in any liability or obligation
imposed on her.
The Company is of the view that, given that Xi’an Puren and Xi’an Hiers had not
commenced any actual business operations since their establishment, and that Dr. Wang
Bing and Dr. Wang Mei, in their capacity as senior management of both the Group and the
above companies, were only involved in high-level decision-making and were not
responsible for the execution of day-to-day administrative matters, neither Dr. Wang Bing
nor Dr. Wang Mei was involved in the said non-compliance, nor were they the persons
responsible for the administrative oversight that led to the failure to complete the
requisite annual inspections.
Mr. You Xiangdong (؇,)aged 62, was appointed as our non-executive Director
in August 2025. Mr. You is primarily responsible for participating in major decisions on
our Group’s operations and development.
Mr. You has over 30 years of experience spanning the medical and investment
sectors. From July 1989 to May 1990, he served as the person in charge of the Preparatory
Office at Sir Run Run Shaw Hospital* (අ˃ᔼ৫ ), affiliated with the
School of Medicine, Zhejiang University. From June 1990 to December 2015, at the Second
Affiliated Hospital of Zhejiang University School of Medicine* (᙮ɚ৫ ),
he held various positions, including resident physician, attending physician, associate
chief physician, chief physician, office director, and hospital vice president. He is a
cardiovascular ultrasound medical expert and a master’s supervisor. Since January 2016,
he has successively held positions including president and director at Zheshang Capital
Co., Ltd.* (ʮ̡), an investment management company principally
engaged in private equity fund management, asset management and investment advisory
services.
Mr. You obtained a bachelor’s degree in Clinical Medicine from Zhejiang Medical
University (now the School of Medicine, Zhejiang University)* (ɽኪdତएϪɽኪ
ᔼኪ৫) from September 1982 to July 1987. He further obtained a master’s degree in
Hospital Management jointly from Nankai University* (කɽኪ) and the Flinders
University of South Australia from August 2006 to August 2008.
Dr. Song Gaoguang (҂৷ᄿ) , aged 42, was appointed as our non-executive Director
in July 2021. Dr. Song is primarily responsible for participating in major decisions on our
Group’s operations and development.
DIRECTORS AND SENIOR MANAGEMENT
– 240 –


--- page 249 ---
Dr. Song previously worked in the Department of Strategic Research at Staidson
Biopharmaceutical Co., Ltd. (Stock code: 300204.SZ), a biopharmaceutical company
principally engaged in the research, development and commercialisation of innovative
therapeutics from July 2012 to August 2016, ultimately helping develop our Company’s
long-term strategy. Before joining the Strategic Research team, Dr. Song worked in the
Staidson’s Department of Pharmacology.
Dr. Song joined Northern Light Venture Capital in August 2016, a venture capital
firm focusing on private equity and venture investments in technology, healthcare and
biopharmaceutical sectors and brought with him a understanding of China’s
pharmaceutical industry. From December 2020 to November 2025, Dr. Song served as a
director at GenFleet Therapeutics (Shanghai) (ʮ̡), a
company listed on the Stock Exchange (stock code: 2595.HK), which is dedicated to
developing novel drug candidates spanning small molecules and biologics. He has
extensive experience in corporate strategic planning and implementation, along with a
background in clinical trial applications, business development, team building, and
marketing management. His primary areas of focus at NLVC are biotech and
biopharmaceuticals, with notable investments including SHIP , Connect Biopharma, Belief
Biomed, and NGGT.
Dr. Song holds a PhD in Biophysics from the Chinese Academy of Medical Sciences*
(ኪ৫), a PhD in Biophysics from Peking Union Medical College* ( ̏ԯ՘ձᔼኪ
৫) in July 2012, and a master’s degree in Biochemical Engineering from the Beijing
Institute of Technology* ( ̏ԯଣʈɽኪ) in July 2008.
Dr. Wang Nayi (❙) , aged 36, was appointed as our non-executive Director in
August 2025. Dr. Wang is primarily responsible for participating in major decisions on our
Group’s operations and development.
Dr. Wang has over 7 years of experience in medical investment and strategic
consulting fields. From January 2018 to October 2019, Dr. Wang worked as a Consultant at
Siemens China Co., Ltd* (ɿʕ਷), a company principally engaged in electrification,
automation and digitalisation solutions, including the provision of industrial automation
systems, smart infrastructure technologies and related technical services in the PRC. From
October 2019 to May 2022, Dr. Wang served as an Investment Manager at WuXi AppTec
Co., Ltd* (ੰᅃ) (Stock code: 603259.SH; 2359.HK),a global pharmaceutical and
biotechnology R&D service platform company principally engaged in laboratory testing,
contract R&D and manufacturing services for pharmaceutical and biotech customers.
Since June 2022, Dr. Wang has been serving as an Investment Director at NRL Capital* ( ॲ
ဧл༟͉), an investment management firm focusing on equity and venture capital
investments in biomedical and healthcare enterprise, dedicated to investing in biomedical
enterprises.
Dr. Wang obtained a bachelor’s degree in Biomedical Engineering from the
University of Minnesota, Twin Cities in May 2012. She further obtained a master’s degree
and a doctoral degree from Yale University in May 2018.
Independent Non-executive Directors
Dr. Xiangli Liuxu (Ԣʬᚃ) , aged 62, was appointed as an independent
non-executive Director and lead independent non-executive Director in September 2025
with effect upon the Listing. He is responsible for supervising and offering independent
judgment to the Board. His primary responsibility is also to facilitate and strengthen
communication (i) among independent non-executive Directors; (ii) between independent
non-executive Directors and the Board; and (iii) with shareholders (in particular, minority
shareholders).
Dr. Xiangli has over 38 years of experience in industrial economics and academic
management. He worked at Shaanxi University of Finance and Economics* ( ৯Гৌ຾ኪ৫)
(currently known as Xi’an Jiaotong University ( Гτʹஷɽኪ)) as a Teaching Assistant,
Lecturer, and Associate Professor in the Department of Industrial Economics from July
1987 to April 2000. During this period, he concurrently served as the Director of Enterprise
Management at Meixian Agricultural Machinery Repair Factory (Shaanxi)* (ጤ༵ዚ
ிᅀ) from September 1987 to August 1988 for practical training. He subsequently held
positions at Xi’an Jiaotong University* ( Гτʹஷɽኪ) as an Associate Professor, Full
Professor, and Chairman of the Labor Union in the School of Management from April 2000
to December 2024. From January 2018 to January 2024, he served as an Independent
Director at Shaanxi Beiyuan Chemical Group* ( ৯Г̏ʩʷʈණྠ ), a chemical
manufacturing enterprise principally engaged in the production of polyvinyl chloride and
related chemical products and as the Vice Dean of the School of Economics and
Management at Xinjiang University* ( อᖛɽኪ) (Seconded to Xinjiang) from December
2017 to December 2020.
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Dr. Xiangli has been serving as an independent director at Shaanxi Meinen Clean
Energy Group Co., Ltd.* (΅ʮ̡) (Stock code: 001299.SZ), a
company engaged in natural gas sales, since March 2023.
Dr. Xiangli obtained a bachelor’s degree in business management from Shaanxi
University of Finance and Economics* ( ৯Гৌ຾ኪ৫) from September 1983 to July 1987
and further obtained a master’s degree in business management from December 1996 to
October 1998. Dr. Xiangli further obtained a Doctoral degree in Business Administration
from Xi’an Jiaotong University* ( Гτʹஷɽኪ) from September 2003 to July 2009.
Dr. Xiangli was awarded the First Prize in the Teaching Competition* ( Гτʹஷɽኪ
౷ஷሙੀ઺ኪᘩᒄɓഃᆤ ) of Xi’an Jiaotong University* ( Гτʹஷɽኪ) in January 2005. He
further received the first prize for the consulting project on state-owned difficult
enterprises from the Shaanxi Provincial Government* (ִ݁޲He also received four
teaching results awards, one award for teaching from the China Financial Education
Fund* (ږand was honored with the title of Excellent Teacher of the
School four times.
Mr. Zhang Wenqiang ( ੵ˖੶) , aged 41, was appointed as an independent
non-executive Director in September 2025 with effect upon the Listing. He is responsible
for supervising and offering independent judgment to the Board.
Mr. Zhang has over 15 years of experience in auditing, corporate consulting and
investment management. From September 2008 to September 2009, he worked at KPMG
Huazhen Certified Public Accountants (Special General Partnership)* (ࢪࠇ
౷ஷΥྫ), an accounting firm principally engaged in providing audit,
assurance and related professional services as an Auditor in the Audit Department. From
October 2009 to May 2012, Mr. Zhang served as an Assistant Manager in the Transaction
and Restructuring Department at KPMG Advisory (China) Limited* (Άุፔ༔ ʕ
ʮ̡), a professional services firm engaged in corporate advisory, including
transaction consulting, restructuring and financial advisory services. In May 2012, he
joined Aerospace Industry Investment Fund Management (Beijing) Co., Ltd.* ( ঘ˂ପุҳ
ʮ̡), an investment management company principally engaged in
managing industrial investment funds focusing on aerospace and high-technology sectors
and currently hold the position of Executive Director.
Mr. Zhang obtained a Bachelor of Economics degree in Finance from Renmin
University of China ( ʕ਷ɛ͏ɽኪ) from September 2004 to June 2008.
Mr. Zhang holds the qualification of Chinese Certified Public Accountant (CPA) in
April 2012.
Mr. Wang Kaifeng (ࢤ) aged 44, was appointed as an independent
non-executive Director in September 2025 with effect upon the Listing. He is responsible
for supervising and offering independent judgment to the Board.
Mr. Wang has over 20 years of experience in pharmaceutical production
management, corporate strategy, and biomedical investment. From February 2003 to
March 2009, he worked at GlaxoSmithKline (Tianjin) Co., Ltd.* (ʮ
̡), a pharmaceutical company engaged in the manufacturing and quality management of
pharmaceutical products as a Chemist and Operational Excellence Expert. From March
2009 to April 2012, Mr. Wang served at Sino-US Tianjin SmithKline & French
Pharmaceutical Co., Ltd.* (ʮ̡), a joint venture pharmaceutical
manufacturer engaged in the production and supply of prescription medicines as an
Operational Excellence Supervisor, EHS Manager, and Production Manager. From July
2012 to February 2020, he held the position of Business Director in the Group Strategic
Management Department at China Resources (Holdings) Co., Ltd.* (ʮ̡),
a conglomerate with operations in consumer products, healthcare, energy and industrials.
From March 2020 to October 2020, Mr. Wang worked as General Manager of the
Investment and Development Department at China Resources Life Science Group Co.,
Ltd.* (ʮ̡ ), a company focuses on life science research, healthcare
product development and related strategic investments. From October 2020 to July 2022,
he served as Health-care business partner and managing director at Qianhai International
(HK) Limited.* (ʮ̡), an investment and asset management company
focusing on healthcare and high-technology sectors. Since August 2022, Mr. Wang has
been a Partner at Efung Capital (HK) Management Co., Ltd.* (ʮ
̡), a company specialising in healthcare and biomedical investments.
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Mr. Wang has also been serving as an independent non-executive Director at
Hangzhou Diagens Biotechnology Co., Ltd.* (ʮ̡ ), a company
engages in the research, development and manufacturing of medical and biotechnology
products, which is engaged in AI medical R&D as well as operation (in the process of
submitting a listing application on the Hong Kong Stock Exchange), since June 2025.
Additionally, Mr. Wang has been serving as director at Hangzhou Adamerck Pharmlabs
Inc.* (ʮ̡ ), a company focuses on new drug R&D since June 2025.
Mr. Wang obtained a Bachelor’s degree in Pharmaceuticals from China
Pharmaceutical University* (ɽኪ) from September 1999 to July 2003. During the
same period, he also studied a second major in Business Administration at China
Pharmaceutical University* (ɽኪ ) from September 2000 to July 2002. He
graduated from the University of Barcelona with a Master's degree in Economics and
Business Administration.
SENIOR MANAGEMENT
The senior management consists of four members who are responsible for our
day-to-day management and operation. The following table sets forth the key information
about the senior management of our Company.
Name Age Position Responsibilities
Date of the
first
appointment
as a senior
management
Date of
joining our
Group
Relationship(s)
with other
Directors and
senior
management
Dr. Wang Bing
(ˮΏ) ......
55 Chairman of our
Board, Chief
Executive Officer
and Executive
Director
Responsible for the overall
strategic planning of our
Group and business
operations and making
key business and
operational decisions of
our Group
December
2020
December
2019
Spouse of
Dr. Wang Mei
Dr. Yu Weiping . . 67 Executive Director,
Senior Vice
President
Responsible for the strategic
planning, overseeing the
CMC activities and the
overall operation
management of our Group
August 2019 August 2019 Nil
Ms. Wang Xiangling
(ޛ.....)
54 Chief Medical Officer Responsible for leading all
the clinical development
and the related functions
October 2024 October 2024 Nil
Mr. Zou Ran
(ཅ್) ......
39 Chief Financial
Officer
Responsible for the business
development and
formulation of financial
and development
strategies and overseeing
the overall financial
management and
corporate development of
our Group
April 2024 April 2024 Nil
For the biographical details of Dr. Wang Bing and Dr. Yu Weiping, see “— Directors”
in this section.
Ms. Wang Xiangling (ޛ)aged 54, was appointed as our Chief Medical Officer
since October 2024. Ms. Wang is responsible for leading all the clinical development and
the related functions.
Ms. Wang assumed the role of Clinical Research Director in the Global Medical
Operations Department at Sanofi (China) Investment Co., Ltd.* (ʮ
̡), a subsidiary of a global pharmaceutical company principally engaged in managing
and supporting Sanofi’s pharmaceutical business and clinical development activities in
the PRC, serving in this capacity from April 2016 to March 2019. From April 2019 to April
2022, Ms. Wang held the position of Vice President of Clinical Medicine at Visen
Pharmaceutical, a biopharmaceutical company focusing on the research, development
and commercialisation of therapies for endocrine and metabolic diseases. She
subsequently served as the Chief Medical Officer at Hope Medicine inc.* ( ձՉ๿ᔼᖹ
ʮ̡) from July 2020 to February 2022, a biopharmaceutical company engaged
in the R&D of innovative drug candidates in dermatology and other therapeutic areas.
From February 2022 to October 2024, Ms. Wang was appointed as Executive Vice President
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of Clinical Development at Shanghai Bio Genuine Biotech Co., Ltd.* (ҦϞ
ʮ̡), a biotechnology company principally engaged in the R&D of innovative
biologics.
Ms. Wang obtained her bachelor’s degree in clinical medicine from Hunan Medical
University* (ɽኪ) (currently known as Xiangya School of Medicine, Central
South University* (ɽኪಱඩᔼኪ৫)) in July 1993. She further obtained her master’s
degree in clinical medicine from Shantou University Medical College* ( ϭ᎘ɽኪᔼኪ৫) in
July 2007.
Mr. Zou Ran (ཅ್) , aged 39, has served as our Chief Financial Officer (CFO) since
April 2024. Mr. Zou is primarily responsible for financing, business development, the
formulation of financial and development strategies, and overseeing the overall financial
management and corporate development of our Group.
Mr. Zou has more than 17 years of experience in corporate finance, management,
and equity investment. From September 2008 to July 2010, Mr. Zou served as an Analyst in
the Transaction Service Department at KPMG Advisory (China) Limited* (Άุፔ༔
ʮ̡). From August 2010 to June 2017, Mr. Zou served as a Senior Investment
Manager at Hony Capital* ( ̾ᆇҳ༟). From July 2017 to March 2019, Mr. Zou served as the
Chief Financial Officer at Hospital Corporation of China Limited* ( ̾ձʠฌᔼᐕණྠ)
(Stock code: 03869.HK), a company principally engaged in hospital investment,
management and operation in the PRC. From April 2019 to May 2022, Mr. Zou served as an
Investment Director at Hony Capital* ( ̾ᆇҳ༟). Mr. Zou was on a career break between
June 2022 to March 2024.
Mr. Zou obtained his bachelor’s degree in management with a major in accounting
from University of International Business and Economics* (ɽኪ) in July
2008. He further obtained his Executive Master of Business Administration (EMBA)
degree from China Europe International Business School (CEIBS)* ( ʕᆄ਷ყʈਠኪ৫) in
November 2022.
GENERAL
As of the Latest Practicable Date, to the best of the knowledge, information and
belief of the Directors after having made all reasonable enquiries,
(i) save as disclosed above, none of the Directors or members of the senior management
has held any directorship in any public company the securities of which are listed
on any securities market in Hong Kong or overseas during the three years
immediately preceding the date of this prospectus;
(ii) save as disclosed above, none of the Directors or members of the senior management
of our Company was related to any other Directors and members of the senior
management;
(iii) save as disclosed in “Appendix IV — Statutory and General Information”, none of
the Directors or general manager of our Company held any interest in the Shares
which would be required to be disclosed pursuant to Part XV of the Securities and
Futures Ordinance; and
(iv) there was no additional matter with respect to the appointment of the Directors that
needs to be brought to the attention of the Shareholders, and there was no additional
information relating to the Directors that is required to be disclosed pursuant to
Rules 13.51(2)(h) to (v) of the Listing Rules as of the Latest Practicable Date.
CONFIRMATION FROM OUR DIRECTORS
Rule 8.10 of the Listing Rules
As of the Latest Practicable Date, none of our Directors and their respective close
associates had any interest in any business which competes or is likely to compete, either
directly or indirectly with our Group’s business which would require 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.
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Rule 3.09D of the Listing Rules
Each of our Directors confirmed that he or she (i) had obtained the legal advice
referred to under Rule 3.09D of the Listing Rules on September 23, 2025, and (ii)
understood his or her obligations as a director of a listed issuer under the Listing Rules.
Rule 3.13 of the Listing Rules
Each of our independent non-executive Directors had confirmed (i) his or her
independence as regards each of the factors referred to in Rules 3.13(1) to (8) of the Listing
Rules; (ii) that he or she had no past or present financial or other interest in the business of
our Company or its subsidiary 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
were no other factors that may affect his or her independence at the time of his or her
appointments. Each of our independent non-executive Directors will inform us and the
Stock Exchange as soon as practicable if there is any subsequent change of circumstances
which may affect his or her independence.
JOINT COMPANY SECRETARIES
Mr. Zou Ran (ཅ್) was appointed as a joint company secretary of our Company in
September 2025 and such appointment will be effective from the Listing Date. He is
primarily responsible for financing, business development, the formulation of financial
and development strategies, and overseeing the overall financial management and
corporate development of our Group. For the biographical details of Mr. Zou, see “ {
Senior Management” in this section.
Ms. Chan Yee Lam (௓ၥᔝ) , is our joint company secretary. Ms. Chan is an executive
of the listing services division at TMF Hong Kong Limited and is responsible for provision
of corporate secretarial and compliance services to listed company clients. Ms. Chan is an
associate member of both The Hong Kong Chartered Governance Institute and The
Chartered Governance Institute in the United Kingdom. Ms. Chan received a Bachelor’s
Degree in Corporate Governance from Hang Seng University of Hong Kong in December
2020 and a Master of Corporate Governance from The Hong Kong Polytechnic University
in October 2025.
BOARD COMMITTEES
We have established three Board Committees in accordance with the relevant PRC
laws and regulations, the Articles of Association and the Corporate Governance Code,
namely the Audit Committee, the Nomination Committee and the Remuneration
Committee.
Audit Committee
We have established an Audit Committee with written terms of reference in
compliance with Rule 3.21 of the Listing Rules and the Corporate Governance Code. The
Audit Committee consists of three Directors, namely Mr. Zhang Wenqiang, Mr. Wang
Kaifeng and Dr. Wang Mei with Mr. Zhang Wenqiang currently serving as the chairperson.
Mr. Zhang Wenqiang has the appropriate professional experiences as required under
Rules 3.10(2) and 3.21 of the Listing Rules. The primary duties of the Audit Committee
include, but are not limited to, the following:
(i) proposing the appointment or change of external auditors to our Board,
monitoring the independence of external auditors and evaluating their
performance;
(ii) examining the financial information of our Company and reviewing financial
reports and statements of our Company;
(iii) examining the financial reporting system, the risk management and internal
control system of our Company, overseeing their rationality, efficiency and
implementation and making recommendations to our Board; and
(iv) dealing with other matters that are authorized by the Board.
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Nomination Committee
We have established a Nomination Committee with written terms of reference in
compliance with Rule 3.27A of the Listing Rules and the Corporate Governance Code. The
Nomination Committee consists of five Directors, namely Dr. Wang Bing, Dr. Wang Mei,
Mr. Zhang Wenqiang, Dr. Xiangli Liuxu and Mr. Wang Kaifeng with Dr. Wang Bing
currently serving as the chairperson. The primary duties of the Nomination Committee
include, but are not limited to, the following:
(i) conducting extensive search and providing our Board with suitable
candidates for our Directors, general managers and other members of the
senior management;
(ii) reviewing the structure, size and composition of our Board (including but not
limited to, gender, age, cultural and educational background, ethnicity, skills,
knowledge and experience) at least annually and make recommendations on
any proposed changes to the Board to complement our Company’s corporate
strategy;
(iii) researching and developing standards and procedures for the election of our
Board members, general managers and members of the senior management,
and making recommendations to our Board;
(iv) assessing the independence of the independent non-executive Directors; and
(v) dealing with other matters that are authorized by the Board.
Remuneration Committee
We have established a Remuneration Committee with written terms of reference in
compliance with Rule 3.25 of the Listing Rules and the Corporate Governance Code. The
Remuneration Committee consists of three Directors, namely Dr. Xiangli Liuxu, Mr. Wang
Kaifeng and Dr. Wang Bing with Dr. Xiangli Liuxu currently serving as the chairperson.
The primary duties of the Remuneration Committee include, but are not limited to, the
following:
(i) advising our Board on the overall remuneration plan and structure of our
Directors and senior management and the establishment of transparent and
formal procedures for determining the remuneration policy of our Company;
(ii) monitoring the implementation of the remuneration system of our Company;
(iii) making recommendations on the remuneration packages of our Directors and
senior management; and
(iv) dealing with other matters that are authorized by the Board.
KEY TERMS OF EMPLOYMENT CONTRACT
We normally enter into (i) an employment contract, (ii) a non-competition
agreement, (iii) a confidentiality agreement and (iv) an intellectual property agreement
with certain of our senior management members. The key terms of such contracts are set
forth below.
T erms
We normally enter into a three-year to five-year employment contract with our
senior management members.
Non-competition
The non-competition obligations shall subsist throughout the employee’s period of
employment and up to two years after termination of employment. During the
non-competition period, the employee shall not, directly or indirectly, accept employment
or hold any position, including but not limited to shareholders, partners, directors,
supervisors, employees, agents, consultants, etc., of any other natural person, legal entity
or other economic organization that produces or operates the same, similar or competing
products, or engages in the same, similar or competing business, with our Company.
Confidentiality
Trade Secrets: The employee shall keep trade secrets, namely business-related
information or technology-related information (including but not limited to operational
information, marketing proposal, purchases information, pricing policy, financial
information, list of customers, business plan, information of R&D etc.) of our Company in
confidence.
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Obligation and duration: The employee shall not divulge or otherwise disclose any
trade secrets to any third party or permit others to use our trade secrets, disclose our trade
secrets to irrelevant staffs within our Company, use the trade secrets for his/her or third
party’s benefits, or duplicate documents or copies of documents that contain our trade
secrets. Such obligation of confidentiality shall subsist for the term of his or her
employment and regardless of the reason of departure, the employee shall return all
materials containing trade secrets to our Company or destruct them under Company’s
supervision.
Intellectual Property Rights
All intellectual property related to an employee’s duties, created during their period
of employment and including, but not limited to, patent rights, rights to patent
applications, trademark rights, rights to trademark registration applications, and
copyrights, shall be exclusively owned by our Company. Employees shall retain the right
of authorship.
CORPORATE GOVERNANCE CODE
Our Company is committed to achieving a high standard of corporate governance
with a view to safeguarding the interests of our Shareholders. To accomplish this, our
Company intends to comply with the Corporate Governance Code set out in Appendix C1
to the Listing Rules and the Model Code for Securities Transactions by Directors of Listed
Issuers set out in Appendix C3 to the Listing Rules after the Listing.
Pursuant to code provision C.2.1 of the Corporate Governance Code, companies
listed on the Stock Exchange are expected to comply with, but may choose to deviate from
the requirement that the responsibilities between the chairman and the chief executive
officer should be segregated and should not be performed by the same individual. We do
not have a separate chairman and chief executive officer and Dr. Wang Bing currently
performs these two roles. The Board believes that vesting the roles of both chairman and
chief executive officer in the same person has the benefit of ensuring consistent leadership
within our Group and enables more effective and efficient overall strategic planning for
our Group. The Board considers that given the size of the board, the supervision of
independent non-executive directors and a solid senior management team, the balance of
power and authority for the present arrangement will not be impaired and this structure
will enable our Company to make and implement decisions promptly and effectively. The
Board will continue to review and consider splitting the roles of chairman of the Board
and the chief executive officer of our Company if and when it is appropriate taking into
account the circumstances of our Group as a whole. Save as disclosed above, our
Company intends to comply with all code provisions under the Corporate Governance
Code after the Listing.
BOARD DIVERSITY POLICY
We have adopted the board diversity policy which sets out the objective and
approach for achieving and maintaining the diversity of the Board in order to enhance its
effectiveness. In accordance with the board diversity policy, our Company seeks to
achieve board diversity by taking into account a number of factors, including but not
limited to gender, age, cultural and educational background, professional experience,
skills, knowledge and/or length of service. The ultimate selection of Board candidates
will be based on merit and potential contribution to our Board having due regard to the
benefits of diversity on the Board and also the specific needs of our Company without
focusing on a single diversity aspect. Our Directors have a balanced mix of knowledge and
skills, including overall management and strategic development as well as knowledge
and experience in areas such as medicine and pharmaceutical research. They obtained
degrees in various areas including, among others, medicine, biochemistry, pharmacology,
biology, business administration, economics, and accounting. Furthermore, our Board has
a diverse age and gender representation. Our Board currently comprises two female
Directors and seven male Directors, ranging from 36 years old to 67 years old.
Given that two out of nine of our Directors are female upon Listing, we will continue
to take steps to promote gender diversity of our Board. After the Listing, we will strive to
achieve gender balance of our Board through the following measures to be implemented
by our Nomination Committee in accordance with our Board Diversity Policy. We will
actively identify female individuals suitably qualified to become our Board members. In
addition, we target to achieve a gender diversity in the composition of our Board by
having female representation of 30% of the members of our Board within three years upon
Listing. With regards to gender diversity on the Board, we recognize the particular
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importance of gender diversity. 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. We will maintain a focus on gender
diversity when recruiting staff at the mid to senior level so as to develop a pipeline of
potential female successors to our Board. Our Group will also 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 reviewed by our nomination
committee periodically to maintain gender diversity of our Board. Taking into account our
existing business model and specific needs as well as the different background of our
Directors, the composition of our Board satisfies our board diversity policy.
Upon the Listing, the Nomination Committee will from time to time discuss and
agree on expected goals to ensure board diversity, and review and, where necessary,
update the board diversity policy to ensure that the policy remains effective. Our
Company will disclose the biographical details of each Director and report on the
implementation of the board diversity policy (including whether we have achieved board
diversity) in its annual corporate governance report.
DIRECTORS’ AND GENERAL MANAGER’S REMUNERATION AND REMUNERATION
OF THE FIVE HIGHEST-PAID INDIVIDUALS
The Directors and senior management members who receive remuneration from our
Company are paid in the forms of salaries, bonuses, allowances and benefits in kind,
equity-settled share award expense and pension scheme contributions. Our independent
non-executive Directors receive compensation based on their responsibilities. The
remuneration of the Directors and senior management members is determined with
reference to the remuneration paid by comparable companies and the achievement of
major operating indicators of our Company.
The aggregate amount of remuneration (including salaries, allowances and benefits
in kind and retirement benefits) paid to the Directors for the two years ended December
31, 2024 and 2025 amounted to RMB3.4 million and RMB3.3 million, respectively.
The five highest paid individuals of our Group in the two years ended December 31,
2024 and 2025 included two and two Directors, respectively. The aggregate amount of
remuneration (including salaries, wage and allowances performance related bonuses and
retirement benefits) incurred by the five highest-paid individuals of our Group (excluding
Directors) for the two years ended December 31, 2024 and 2025 amounted to RMB4.0
million and RMB5.9 million, respectively.
Under the current compensation arrangement, we estimate the total compensation
before taxation, including estimated share-based compensation, to be accrued to our
Directors for the year ending December 31, 2026 to be approximately RMB3.3 million. The
actual remuneration of Directors in 2026 may be different from the expected
remuneration.
We confirmed that during the Track Record Period, no remuneration was paid by
our Company to, or receivable by, our Directors or the five highest paid individuals as an
inducement to join or upon joining our Company or as compensation for loss of office in
connection with the management positions of our Company or any subsidiary of our
Company.
During the Track Record Period, none of our Directors waived any remuneration.
Save as disclosed above, no other payments have been paid, or are payable, by our
Company or our subsidiary to our Directors or the five highest-paid individuals during
the Track Record Period.
COMPLIANCE ADVISER
Our Company has appointed Halcyon Capital Limited as our Compliance Adviser
in compliance with Rules 3A.19 of the Listing Rules. The Compliance Adviser will provide
us with guidance and advice as to compliance with the Listing Rules and other applicable
laws, rules, codes and guidelines. Pursuant to Rule 3A.23 of the Listing Rules, the
Compliance Adviser 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 and share repurchases;
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(iii) where we propose to use the proceeds from the Global Offering in a manner
different from that detailed in this prospectus or where our business activities,
developments or results deviate from any forecast, estimate or other
information in this prospectus; and
(iv) where the Stock Exchange makes an inquiry to our Company in accordance
with Rule 13.10 of the Listing Rules.
Pursuant to Rule 3A.24 of the Listing Rules, the Compliance Adviser 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 Adviser will also inform our
Company of any new or amended law, regulation or code in Hong Kong applicable to us,
and advise us on the continuing requirements under the Listing Rules and applicable laws
and regulations.
The term of the appointment will commence on the Listing Date and is expected to
end on the date on which our Company complies with Rule 13.46 of the Listing Rules in
respect of our financial results for the first full financial year commencing after the
Listing.
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You should read the following discussion and analysis with our consolidated
financial information, including the notes thereto, included in the Accountants’
Report in Appendix I to this prospectus. Our consolidated financial information has
been prepared in accordance with International Financial Reporting Standards issued
by the International Accounting Standards Board, which may differ in material
aspects from generally accepted accounting principles in other jurisdictions,
including the United States. You should read the entire Accountants’ Report and not
merely rely on the information contained in this section.
The following discussion and analysis contain forward-looking statements
that reflect our current views with respect to future events and financial performance.
These statements are based on our assumptions and analysis in light of our experience
and perception of historical trends, current conditions and expected future
developments, as well as other factors we believe are appropriate under the
circumstances. However, whether actual outcomes and developments will meet our
expectations and predictions depends on a number of risks and uncertainties. In
evaluating our business, you should carefully consider the information provided in
the section headed “Risk Factors” and “Business” in this prospectus.
For the purpose of this section, unless the context otherwise requires, references
to the year of 2024 or 2025 refer to our financial year ended December 31 of such year.
Unless the context otherwise requires, financial information described in this section
is described on a consolidated basis. Discrepancies between totals and sums of
amounts listed in this section in any table or elsewhere in this prospectus may be due
to rounding.
OVERVIEW
We are a biotechnology company specializing in the discovery, development and
commercialization of bi-/multi-specific peptide drugs for the treatment of metabolic
diseases as well as cardiovascular and cerebrovascular diseases, with our Core Product in
Phase III clinical trials.
BASIS OF PRESENTATION
Our historical financial information has been prepared based on the accounting
policies which conform with IFRS Accounting Standards as issued by International
Accounting Standards Board (the “IASB”). Further details of the basis of presentation of
historical financial information are set out in Note 2 to the Accountants’ Report in
Appendix I to this prospectus.
The historical financial information has been prepared on the historical cost basis
except for certain financial instruments that are measured at fair values at the end of each
reporting period, as explained in the material accounting policy information set out in
Note 4 to the Accountants’ Report in Appendix I to this prospectus.
KEY FACTORS AFFECTING OUR PERFORMANCE
Our historical results of operations have been affected by a number of important
factors, many of which are out of our control and we believe will continue to affect our
financial position and results of operations in the future. Our results are principally
affected by the following factors:
Unmet Medical Needs and Attractive Market Opportunities
Globally, the peptide drug market has been developing, with several products
approved and therapeutic applications extending beyond metabolic diseases to
cardiovascular, central nervous system, endocrine, gastrointestinal, hematologic,
ophthalmic and orthopedic conditions. The global peptide drug market increased from
US$61.7 billion in 2019 to US$109.6 billion in 2024, representing a CAGR of 12.2% and is
expected to reach US$233.8 billion by 2030, representing a CAGR of 13.5%. In China, the
peptide drug market increased from RMB53.9 billion in 2019 to RMB60.2 billion in 2024,
representing a CAGR of 2.3% and is expected to reach RMB165.2 billion by 2030,
representing a CAGR of 18.3%. With advantages in efficacy, safety and broad-spectrum
attribute, peptide drugs are well positioned to address a substantial amount of unmet
medical needs and support continued market growth.
FINANCIAL INFORMATION
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Our financial performance and future growth are closely tied to the peptide drug
market, and we believe we are well positioned to capitalize on the expanding peptide
market. Our Core Product, MT1013, is being developed for CKD-SHPT, and it has the
potential to expand to indications such as CKD-MBD with Osteoporosis and CKD-SHPT
not on Dialysis. The global prevalence of CKD reached 1,065.5 million in 2024 and is
expected to reach 1,289.7 million by 2030. In China, the prevalence of CKD reached 161.5
million in 2024 and is expected to reach 175.0 million by 2030. For details of peptide drug
and relative disease drug markets, see “Industry Overview” in this prospectus.
Development and Commercialization of Our Drug Candidates
The success of our Company and the outcomes of our operations rely on our
capacity to effectively progress our drug development initiatives, achieve satisfactory
safety and efficacy outcomes in clinical trials, secure necessary regulatory approvals, and
successfully commercialize our pipeline products. With a strategic focus on metabolic
diseases (kidney-related in particular) and cardiovascular diseases, as of the Latest
Practicable Date, we had established a diversified pipeline of bi-specific and
multi-specific peptide product candidates, including one Core Product, MT1013, three
Key Products, XTL6001, MT1002 and MT200605, as well as other product candidates at
various stages of development. For details of our drug candidates, see “Business — Our
Candidate Drugs and Pipeline” in this prospectus.
Currently, our Core Product, MT1013, is undergoing the Phase III-C01 clinical trial
for the treatment of CKD-SHPT in CKD patients receiving maintenance hemodialysis. We
expect to complete this trial by the end of 2026 and submit the NDA in early 2027. Looking
forward, we expect to commercialize one or more of our drug candidates over the coming
years as they move towards the final stages of development. However, our ability to
generate revenue from our pipeline products to cover R&D expenses and other expenses
will depend on multiple factors, including but not limited to our ability to secure
adequate manufacturing capacity, collaboration with competent third-party partners, as
well as making our products accessible to, affordable for and accepted by the addressable
patient population who are in need of high-quality products that bring comprehensive
benefits for metabolic and cardiovascular diseases.
Our Cost Structure
Our results of operations are significantly affected by our cost structure, which has
historically consisted primarily of R&D expenses, finance costs, and administrative
expenses, details of which are set out below:
Research and development expenses. Our R&D expenses primarily consist of (i)
experiments and tests expenses, (ii) staff costs and welfare expenses, (iii) depreciation and
amortization expenses, (iv) material costs, (v) utility expenses, (vi) travel expenses, and
(vii) other expenses allocable to our R&D activities. Our R&D expenses amounted to
RMB107.0 million and RMB130.1 million for 2024 and 2025, respectively.
Finance costs. Our finance costs primarily consist of interest expenses on bank
borrowings, lease liabilities, and redemption liabilities. Our finance costs amounted to
RMB37.6 million and RMB67.0 million for 2024 and 2025, respectively.
Administrative expenses. Our administrative expenses primarily consist of (i) staff
costs and welfare expenses, (ii) professional service fees, (iii) depreciation and
amortization expenses, (iv) travel expenses, (v) utility expenses, and (vi) other expenses
allocable to our administrative activities. Our administrative expenses amounted to
RMB18.8 million and RMB23.5 million for 2024 and 2025, respectively.
Funding for Our Operations
During the Track Record Period, we funded our operations primarily through
equity and debt financing. Going forward, subject to obtaining NDA approval for our
Core Product MT1013 for the treatment of CKD-SHPT in CKD patients receiving
maintenance hemodialysis, and assuming the successful commercialization of one or
more of our drug candidates, we expect to fund our operations primarily with revenue
generated from the sale of commercialized drug products. However, with the continuing
expansion of our business, we may require further funding through public or private
offerings, debt financing, collaboration and licensing arrangements or other funding
sources. Any fluctuation in the funding for our operations will impact our cash flow and
our results of operations.
FINANCIAL INFORMATION
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MATERIAL ACCOUNTING POLICY INFORMATION AND CRITICAL ACCOUNTING
JUDGMENTS
Our discussion and analysis of our financial position and results of operations is
based on our historical financial information, which have been prepared in accordance
with accounting principles that conform with IFRS Accounting Standards. The
preparation of historical financial statements requires us to make judgments that affect
the reported amounts of assets, liabilities, costs and expenses. We evaluate our judgments
on an ongoing basis, and our actual results may differ from these estimates. We base our
estimates on historical experience, known trends and events, contractual milestones and
other various factors that are believed to be reasonable under the circumstances, the
results of which form the basis for making judgments about the carrying values of assets
and liabilities that are not readily apparent from other sources.
Our material accounting policy information and critical accounting judgments,
which are important for an understanding of our financial position and results of
operations, are set forth in detail in Notes 4 and 5 to the Accountants’ Report in Appendix
I to this prospectus.
Among them, we believe the accounting policy information and accounting
judgments in respect of the following are of particularly critical importance to us or
involve the most significant estimates and judgments used in the preparation of our
financial statements: (i) leases, our Group as lessee, (ii) foreign currencies (including the
accounting treatments for exchange differences arising on the translation of monetary
items and the translation of income and expenses items, respectively), (iii) borrowing
costs, (iv) R&D expenditure, (v) government grants, (vi) employee benefits, (vii)
share-based payments, (viii) plant and equipment, (ix) cash and cash equivalents, and (x)
financial instruments.
For details, please refer to Notes 4 and 5 to the Accountants’ Report in Appendix I to
this prospectus.
FINANCIAL INFORMATION
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DESCRIPTION OF SELECTED COMPONENTS OF CONSOLIDATED STATEMENTS
OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME
The selected financial information set out below has been extracted from our
historical financial information set out in the Accountants’ Report in Appendix I to this
prospectus:
For the Year Ended
December 31,
2024 2025
RMB’000 RMB’000
Other income ........................... 4,002 2,301
Other gains and losses, net ................ 2,670 43,268
Administrative expenses .................. (18,812) (23,490)
Research and development expenses ......... (107,022) (130,089)
Listing expenses ......................... – (9,901)
Finance costs ........................... (37,646) (67,003)
Loss before tax .......................... (156,808) (184,914)
Income tax expense ...................... (24) –
Loss for the year ........................ (156,832) (184,914)
Other comprehensive income for the year
Item that will be reclassified to profit or loss:
Exchange difference arising on translation of
foreign operations ...................... 9 2
T otal comprehensive expense for the year .... (156,823) (184,912)
Loss for the year attributable to:
– Owners of the Company ............... (154,632) (182,507)
– Non-controlling interests ............... (2,200) (2,407)
(156,832) (184,914)
Total comprehensive expense for the year
attributable to:
– Owners of the Company ............... (154,623) (182,505)
– Non-controlling interests ............... (2,200) (2,407)
(156,823) (184,912)
Loss per share (RMB)
Basic and diluted ........................ (0.66) (0.75)
FINANCIAL INFORMATION
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Other Income
During the Track Record Period, our other income primarily consisted of (i) interest
income on bank deposits, and (ii) government grants, which mainly represent subsidies
from local government authorities to compensate expenditures arising from our R&D
activities and are generally one-off in nature. The following table sets forth a breakdown
of our other income for the years indicated:
For the Year Ended
December 31,
2024 2025
RMB’000 RMB’000
Interest income on bank deposits ............ 3,235 2,008
Government grants ...................... 7 6 7 2 9 3
4,002 2,301
Other Gains and Losses, Net
During the Track Record Period, our other gains and losses, net primarily consisted
of (i) gain on non-substantial modification of redemption liabilities arising from an
extension of the redemption date in relation to our Pre-IPO Investment, (ii) gain on early
termination of a lease, (iii) gain on fair value changes from financial assets at FVTPL,
which mainly represent gains resulting from changes in the fair value of our structured
deposits purchased from banks, and (iv) net foreign exchange gains. The following table
sets forth a breakdown of our other gains and losses, net for the years indicated:
For the Year Ended
December 31,
2024 2025
RMB’000 RMB’000
Gain on non-substantial modification of
redemption liabilities ................... – 42,081
Gain on early termination of a lease ......... 4 1 4 –
Gain on fair value changes from
financial assets at FVTPL ................ 2,028 865
Net foreign exchange gains ................ 2 2 8 4 8 0
Others (1) ............................... – (158)
2,670 43,268
Note:
(1) Others primarily consisted of a monetary damage of RMB157 thousand paid to a supplier for
settling the termination of a contract.
FINANCIAL INFORMATION
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Administrative Expenses
During the Track Record Period, our administrative expenses primarily consisted of
(i) staff costs and welfare expenses, primarily including salaries, bonuses and benefits of
our management and administrative personnel, (ii) professional service fees, primarily
including fees for recruitment, financing advisory, employee training, (iii) depreciation
and amortization expenses for plant and equipment and right-of-use assets for
administrative purpose, (iv) travel expenses, (v) utility expenses, and (vi) other expenses
allocable to our administrative activities, such as maintenance expenses, service charges,
and entertainment expenses. The following table sets forth a breakdown of our
administrative expenses for the years indicated:
For the Year Ended
December 31,
2024 2025
RMB’000 RMB’000
Staff costs and welfare expenses ............ 11,220 14,672
Professional service fees .................. 3,438 5,219
Depreciation and amortization expenses ..... 1,374 1,051
Travel expenses ......................... 6 8 7 6 2 6
Utility expenses ......................... 7 5 0 9 7 8
Others ................................ 1,343 944
T otal ................................. 18,812 23,490
Research and Development Expenses
During the Track Record Period, our R&D expenses mainly consisted of (i)
experiments and tests expenses, primarily representing expenses in relation to our
pre-clinical studies and clinical trials, (ii) staff costs and welfare expenses, primarily
including salaries, bonuses and benefits of our R&D personnel, (iii) depreciation and
amortization expenses for plant and equipment and right-of-use assets for R&D purpose,
(iv) material costs, primarily in relation to fees for raw material procurement for the
clinical development of our drug candidates; (v) utility expenses, (vi) travel expenses, and
(vii) other expenses allocable to our R&D activities, such as intellectual property agency
fees, document translation fees, and maintenance expenses. The following table sets forth
a breakdown of our R&D expenses for the years indicated:
For the Year Ended
December 31,
2024 2025
RMB’000 RMB’000
Experiments and tests expenses ............ 67,274 78,813
Staff costs and welfare expenses ............ 28,115 35,749
Depreciation and amortization expenses ..... 7,014 5,523
Material costs .......................... 1,582 5,174
Utility expenses ......................... 6 6 3 8 7 4
Travel expenses ......................... 1,977 3,211
Others ................................ 3 9 7 7 4 5
T otal ................................. 107,022 130,089
For 2024 and 2025, we incurred R&D expenses for our Core Product MT1013
amounting to RMB66.7 million and RMB84.4 million, respectively, representing 62.3% and
64.9% of our total R&D expenses for the same year, respectively. The R&D expenses for our
Core Product increased from RMB66.7 million in 2024 to and RMB84.4 million in 2025,
primarily due to an increase in experiments and tests expenses in connection with the
Phase III-C01 clinical trial of our Core Product, including expenses related to patient
enrollment.
FINANCIAL INFORMATION
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Finance Costs
During the Track Record Period, our finance costs mainly consisted of interest
expenses on bank borrowings, lease liabilities, and redemption liabilities. The following
table sets forth a breakdown of our finance costs for the years indicated:
For the Year Ended
December 31,
2024 2025
RMB’000 RMB’000
Interest expense on:
– bank borrowings ..................... 6 6 9 9 8 5
– lease liabilities ....................... 2 0 2 6 6
– redemption liabilities ................. 36,775 65,952
37,646 67,003
PERIOD-TO-PERIOD COMPARISON OF RESULTS OF OPERATIONS
Year Ended December 31, 2025 Compared to Year Ended December 31, 2024
Other income
Our other income decreased by 42.5% from RMB4.0 million for 2024 to RMB2.3
million for 2025. The decrease was primarily attributable to a decrease in interest income
on bank deposits mainly resulting from (i) a decrease in bank deposits balance following
withdrawals for R&D purposes, and (ii) a decrease in interest rates.
Other gains and losses, net
Our other gains and losses, net increased by 1,503.7% from RMB2.7 million for 2024
to RMB43.3 million for 2025, primarily due to gain on non-substantial modification of
redemption liabilities arising from an extension of the redemption date in relation to our
Pre-IPO Investment, partially offset by (i) a decrease in gain on fair value changes from
financial assets at FVTPL which was in turn primarily due to a decrease in interest rates
applicable to our financial assets at FVTPL, and (ii) a decrease in gains of early
termination of a lease.
Administrative expenses
Our administrative expenses increased by 25.0% from RMB18.8 million for 2024 to
RMB23.5 million for 2025, primarily due to (i) an increase in staff costs and welfare
expenses of RMB3.5 million due to an expansion of our administrative related teams such
as our finance team and legal team, and (ii) an increase in professional service fees of
RMB1.8 million due to the engagement of professional services such as financial advisory
and due diligence investigations in connection with the Series D financing.
Research and development expenses
Our R&D expenses increased by 21.6% from RMB107.0 million for 2024 to RMB130.1
million for 2025, primarily due to (i) an increase in experiments and tests expenses of
RMB11.5 million, and (ii) an increase in staff costs and welfare expenses for our R&D
personnel of RMB7.6 million, in connection with our R&D activities with respect to, in
particular, our Core Product, MT1013, and a Key Product, MT200605. Among our product
candidates, (a) MT1013 launched Phase III-C01 clinical trial in the second half of 2025,
including commencing patient enrollment and treatment in September 2025, and (b)
MT200605 launched Phase II clinical trial in 2025 as well.
FINANCIAL INFORMATION
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Finance costs
Our finance costs increased by 78.2% from RMB37.6 million for 2024 to RMB67.0
million for 2025, primarily due to the increase in interest expenses on redemption
liabilities. Further details of redemption liabilities are set out in Note 25 to the
Accountants’ Report in Appendix I to this prospectus.
Loss for the year
For the reasons described above, our loss for the year increased by 17.9% from
RMB156.8 million for 2024 to RMB184.9 million for 2025.
DISCUSSION OF CERTAIN SELECTED ITEMS FROM THE CONSOLIDATED
STATEMENTS OF FINANCIAL POSITION
The following table sets forth our consolidated statements of financial position as of
the dates indicated:
As of December 31,
2024 2025
RMB’000 RMB’000
Non-current assets
Plant and equipment ..................... 9,216 6,622
Right-of-use assets ....................... 2,842 18,775
Term deposits ........................... 30,300 31,020
Other receivables ........................ 18,923 11,283
Restricted bank deposits .................. – 1,560
61,281 69,260
Current assets
Prepayments and other receivables .......... 5,513 24,186
Financial assets at fair value through
profit or loss (“FVTPL”) ................. 54,611 95,209
Amount due from a related party ........... 6 5 2 1,087
Restricted bank deposits .................. – 8 6 3
Term deposits ........................... 60,540 60,300
Cash and cash equivalents ................. 64,661 80,556
185,977 262,201
Current liabilities
Trade and other payables .................. 45,580 82,627
Bank borrowings ........................ 1,760 48,100
Amount due to the Controlling Shareholder . . . 28,333 –
Lease liabilities .......................... 2,259 1,399
Redemption liabilities .................... – 134,281
77,932 266,407
Net current assets (liabilities) ............. 108,045 (4,206)
T otal assets less current liabilities .......... 169,326 65,054
FINANCIAL INFORMATION
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As of December 31,
2024 2025
RMB’000 RMB’000
Non-current liabilities
Bank borrowings ........................ 42,253 –
Lease liabilities .......................... 2 8 0 2 0 2
Redemption liabilities .................... – 1,024,737
42,533 1,024,939
Net assets/(liabilities) .................... 126,793 (959,885)
Capital and reserves
Paid-in capital/share capital ............... 4,985 5,474
Reserves/(deficits) ....................... 106,826 (977,934)
Equity/(deficits) attributable to owners of
the Company .......................... 1 1 1,811 (972,460)
Non-controlling interests .................. 14,982 12,575
T otal equity/(deficits) .................... 126,793 (959,885)
Plant and Equipment
During the Track Record Period, our plant and equipment primarily consisted of (i)
machinery and equipment, (ii) motor vehicles, (iii) computer equipment and software, (iv)
office equipment, and (v) leasehold improvements. Our plant and equipment decreased
from RMB9.2 million as of December 31, 2024 to RMB6.6 million as of December 31, 2025,
primarily due to the depreciation of our plant and equipment. The following table sets
forth a breakdown of our plant and equipment as of the dates indicates:
As of December 31,
2024 2025
RMB’000 RMB’000
Machinery and equipment ................. 8,034 5,919
Motor vehicles .......................... 6 9 6 9
Computer equipment and software .......... 6 1 7 4 3 7
Office equipment ........................ 1 5 8 7 9
Leasehold improvement ................... 3 3 8 1 1 8
T otal.................................. 9,216 6,622
Right-of-use Assets
During the Track Record Period, our right-of-use assets primarily related to the
lease of properties and leasehold land. Our right-of-use assets increased from RMB2.8
million as of December 31, 2024 to RMB18.8 million as of December 31, 2025, primarily due
to the completion of the acquisition of a leasehold land in Taizhou by our Group.
Impairment Assessment for Non-financial Assets
At the end of each reporting period, we assess the carrying amounts of our
non-financial assets to determine whether there is any indication of impairment, in
accordance with the accounting policy set out in Note 4 to the Accountants’ Report in
Appendix I to this prospectus. During the Track Record Period, we recorded net losses
primarily because we remained in the R&D stage and made significant investments in our
R&D activities, which was within the expectation of our Directors. As we progress toward
the commercialization of our product candidates, we expect to narrow our losses in the
foreseeable future. Having reviewed both internal and external sources of information, we
did not identify any indicators of impairment for our non-financial assets. Accordingly,
we concluded that there was no impairment needed for our non-financial assets as of
December 31, 2024 and 2025.
FINANCIAL INFORMATION
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Impairment Assessment for Investment in the Subsidiaries
Where our carrying amount invested in the subsidiary materially exceed that
subsidiary net asset values, our management will consider whether there is any need for
impairment. Management team has performed impairment assessments of the investment
in subsidiaries throughout the Track Record Period and have concluded that no
impairment charge was required.
T erm Deposits
As of December 31,
2024 2025
RMB’000 RMB’000
T erm deposits
– Non-current ......................... 30,300 31,020
– Current ............................ 60,540 60,300
Our non-current deposits remained relatively stable at RMB31.0 million as of
December 31, 2025 compared to RMB30.3 million as of December 31, 2024.
Our current deposits remained relatively stable at RMB60.3 million as of December
31, 2025 compared to RMB60.5 million as of December 31, 2024.
Prepayments and Other Receivables
During the Track Record Period, our prepayments and other receivables primarily
consisted of (i) deferred issue costs, (ii) prepaid listing expenses, (iii) value-added tax
recoverable, representing value-added tax paid by us on purchases that are deductible
against future value-added tax payable, (iv) prepayments for R&D services, (v) rental
deposits for right-of-use assets, (vi) other receivables such as deposits paid to our
suppliers, and (vii) other prepayments such as prepayment for property management
services. The following table sets forth the components of our prepayments and other
receivables as of the dates indicated:
As of December 31,
2024 2025
RMB’000 RMB’000
Deferred issue costs ...................... – 2,435
Prepaid listing expenses ................... – 8
Other receivables ........................ 2 0 4 3 7 4
Rental deposits for right-of-use assets ....... 2 8 1 2 8 1
Prepayments for research and
development services .................. 4,900 9,150
Value added tax (“VAT”) recoverable ........ 18,723 22,604
Other prepayments ...................... 3 2 8 6 1 7
24,436 35,469
Less: Amounts recoverable within one year
shown under current assets ......... (5,513) (24,186)
Amounts shown under non-current assets .... 18,923 11,283
Our prepayments and other receivables increased from RMB24.4 million as of
December 31, 2024 to RMB35.5 million as of December 31, 2025, primarily due to the
increase in prepayments for R&D services and the increase in VAT recoverable.
FINANCIAL INFORMATION
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As of April 30, 2026, RMB9.5 million, representing 26.8% of our prepayments and
other receivables as of December 31, 2025, had been settled.
Financial Assets at FVTPL
During the Track Record Period, our financial assets at FVTPL primarily
represented the structured deposits we purchased from banks in the PRC. Our financial
assets at FVTPL increased from RMB54.6 million as of December 31, 2024 to RMB95.2
million as of December 31, 2025, primarily due to an increase in our structured deposits
following the completion of the Series D financing.
We purchase low-risk wealth management products as a supplemental means to
improve utilization of our cash on hand. We believe that investment in low-risk financial
products helps us make better use of our cash, expand our source of income while
ensuring sufficient cash flow for business operation or capital expenditures. The
purchases of wealth management products are carefully reviewed and assessed by our
finance department and are subject to the approval of our senior management team.
Additionally, we have established a set of risk management and capital preservation
investment policy and have implemented a series of internal control measures regarding
our investment in wealth management products. These policies and measures include:
• we make investment decisions after thoroughly considering several factors,
including but not limited to the macro-economic environment, general market
conditions, risk control and credit of issuing financial institutions, our
working capital conditions and the expected returns;
• we only purchase low-risk wealth management products issued by qualified
financial institutions; and
• after making an investment, we closely monitor its performance and fair value
on a regular basis.
Our investment in financial assets will be subject to compliance with Chapter 14 of
the Listing Rules after Listing.
Amount Due from a Related Party
As of December 31, 2024 and 2025, we recorded amounts due from a related party,
Zhongrui Zekang, amounting to RMB0.7 million and RMB1.1 million, respectively. These
amounts represent funds collected by Zhongrui Zekang on our behalf pursuant to our
share incentive scheme, specifically relating to employees’ payments of exercise or
subscription prices for share options or shares. The outstanding balance will be settled
prior to the Listing. See Note 23 to the Accountants’ Report in Appendix I to this
prospectus for a detailed description of the transaction.
Cash and Cash Equivalents
During the Track Record Period, our cash and cash equivalents primarily
represented deposits for the purpose of meeting our short-term cash commitments. Our
cash and cash equivalents increased from RMB64.7 million as of December 31, 2024 to
RMB80.6 million as of December 31, 2025, primarily due to the completion of the Series D
financing, partially offset by cash outflows from our business operations including R&D
activities.
T rade and Other Payables
During the Track Record Period, our trade and other payables primarily consisted of
(i) trade payables and accruals for R&D expenses in connection with our purchase of
materials and third-party contracting services for our R&D activities, (ii) payroll payable,
(iii) other tax payables, (iv) government grant collected on behalf of employees, applied
for by our Group and to be distributed to eligible employees in accordance with local
government policies, (v) accrued listing expenses, (vi) accrued issue costs, (vii) cash
FINANCIAL INFORMATION
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received in respect of restricted shares, and (viii) others such as employee
reimbursements. The following table sets forth a breakdown of our trade and other
payables as of the dates indicated:
As of December 31,
2024 2025
RMB’000 RMB’000
Trade payables and accruals for research and
development expenses .................. 33,371 53,690
Payroll payable ......................... 6,491 8,818
Other tax payables ....................... 4 0 8 6 7 6
Government grant collected on behalf of
employees ............................ 3,157 3,053
Accrued listing expenses .................. – 4,226
Accrued issue costs ...................... – 1,105
Cash received under the Share
Incentive Scheme ...................... – 7,268
Others ................................. 2,153 3,791
45,580 82,627
Our trade and other payables increased from RMB45.6 million as of December 31,
2024 to RMB82.6 million as of December 31, 2025, primarily due to (i) an increase in trade
payables and accruals for R&D expenses, (ii) accrual of listing expenses, and (iii) cash
received in respect of restricted shares from employees to whom share incentives were
granted in the form of restricted shares.
Our trade payables are non-interest-bearing and our average credit term of trade
payables is generally ranged between 15 to 90 days. The following table sets forth an aging
analysis of our trade payables based on the invoice date and accruals which have not yet
been billed as of the dates indicated:
As of December 31,
2024 2025
RMB’000 RMB’000
1-90 days .............................. 1,158 630
91-365 days ............................. 1,575 319
1 to 2 years ............................. 4,351 20
2 to 3 years ............................. 4 4 0 1,925
Over 3 years ............................ 2 0 7 6 4 4
Subtotal ............................... 7,731 3,538
Not yet billed ........................... 25,640 50,152
T otal.................................. 33,371 53,690
As of April 30, 2026, RMB6.4 million, representing 11.9% of our trade payables and
accruals for R&D expenses as of December 31, 2025, had been settled.
Amount Due to the Controlling Shareholder
As of December 31, 2024 and 2025, we recorded amounts due to the Controlling
Shareholder of RMB28.3 million and nil, respectively, representing consideration payables
for Dr. Wang Bing’s equity interest in Xi’an Biocare acquired by us in August 2023. See
Note 23 to the Accountants’ Report in Appendix I to this prospectus for a detailed
description of the transaction.
FINANCIAL INFORMATION
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LIQUIDITY AND CAPITAL RESOURCES
During the Track Record Period, our primary uses of cash were for R&D activities,
procurement of materials and equipment, and general operating expenses. We recorded
net cash used in operating activities of RMB107.7 million and RMB137.1 million for 2024
and 2025, respectively. During the Track Record Period and up to the Latest Practicable
Date, we had financed our operations primarily through equity and debt financing and we
had not experienced any difficulty in obtaining such financing. As of April 30, 2026, the
latest practicable date for determining our indebtedness, we had cash and cash
equivalents of RMB101.2 million.
Current Assets and Current Liabilities
The following table sets forth our current assets and current liabilities as of the dates
indicated:
As of December 31,
As of
April 30,
2024 2025 2026
RMB’000 RMB’000 RMB’000
(Unaudited)
Current assets
Prepayments and other
receivables ................. 5,513 24,186 14,726
Financial assets at FVTPL ....... 54,611 95,209 160,209
Amount due from a related party. 652 1,087 387
Restricted bank deposits ....... – 8 6 3 2 0 0
Term deposits ................ 60,540 60,300 70,300
Cash and cash equivalents ...... 64,661 80,556 101,200
T otal current assets 185,977 262,201 347,022
Current liabilities
Trade and other payables ....... 45,580 82,627 94,754
Bank borrowings .............. 1,760 48,100 –
Amount due to the Controlling
Shareholder ............... 28,333 – –
Lease liabilities ............... 2,259 1,399 762
Redemption liabilities .......... – 134,281 139,648
T otal current liabilities ........ 77,932 266,407 235,164
Net current assets (liabilities) ... 108,045 (4,206) 111,858
As of April 30, 2026, we recorded net current assets of RMB111.9 million, compared
to net current liabilities of RMB4.2 million as of December 31, 2025, primarily due to (i) an
increase in financial assets at FVTPL arising from our purchase of wealth management
products, (ii) an increase in term deposits, and (iii) an increase in cash and cash
equivalents, all in connection with our receipt of a non-refundable upfront payment of
RMB200 million pursuant to an agreement we entered into with Everest in February 2026,
as partially offset by an increase in trade and other payables in connection with our
business operations in the first four months of 2026.
As of December 31, 2025, we recorded net current liabilities of RMB4.2 million,
compared to net current assets of RMB108.0 million as of December 31, 2024, primarily
because (i) part of the non-current portion of our bank borrowings became current, and (ii)
redemption liabilities of RMB134.3 million arising from certain investors’ conditional
redemption rights were classified as current liabilities.
FINANCIAL INFORMATION
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We expect our net current liabilities position to substantially improve upon Listing,
as certain investors’ redemption rights will automatically terminate and the redemption
liabilities will be transferred to equity upon Listing. We also maintain banking
relationships and may, where appropriate, raise long-term borrowings to replace our
short-term borrowings to secure more stable funding resources.
Cash Flows
The following table sets forth key items of our consolidated statements of cash flows
for the years indicated:
For the Year Ended
December 31,
2024 2025
RMB’000 RMB’000
Operating activities
Loss before tax .......................... (156,808) (184,914)
Adjustments for:
Interest income .......................... (3,235) (2,008)
Gain on fair value changes from financial
assets at FVTPL ........................ (2,028) (865)
Depreciation of plant and equipment ........ 4,853 3,463
Depreciation of right-of-use assets .......... 3,535 3,111
Gain on early termination of a lease ......... (414) –
Foreign exchange gains ................... (228) (480)
Finance costs ........................... 37,646 67,003
Gain on non-substantial modification of
redemption liabilities ................... – (42,081)
Operating cash flows before movements
in working capital ...................... ( 1 16,679) (156,771)
Decrease/(increase) in amounts due from
a related party ......................... 4 9 (435)
Increase in prepayments and
other receivables ....................... (1,970) (8,598)
Increase in trade and other payables ......... 10,890 28,674
Cash used in operations ................... (107,710) (137,130)
Income tax paid ......................... (32) –
NET CASH USED IN OPERATING
ACTIVITIES .......................... (107,742) (137,130)
Investing activities
Interest received ........................ 10,095 1,528
Payments of right-of-use assets ............. – (16,076)
Purchase of plant and equipment ........... (1,302) (878)
Purchase of financial assets at FVTPL ........ (634,900) (391,500)
Redemption on maturity of financial assets
at FVTPL ............................. 690,910 351,767
Placement of term deposits ................ (90,000) (60,000)
Withdrawal of term deposits ............... 80,000 60,000
Placement of restricted bank deposit ......... – (2,423)
NET CASH FROM/(USED IN) INVESTING
ACTIVITIES .......................... 54,803 (57,582)
FINANCIAL INFORMATION
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For the Year Ended
December 31,
2024 2025
RMB’000 RMB’000
Financing activities
Proceeds from issue of shares .............. – 235,500
Payments for accrued issue costs ........... – (1,330)
Purchase of additional interest in a subsidiary
from the Controlling Shareholder ......... – (28,333)
Proceeds from subscription price of restricted
share units ........................... – 7,268
Drawdown of bank borrowings ............ 25,463 5,147
Repayment of bank borrowings ............ (650) (1,060)
Interest paid for bank borrowings .......... (669) (985)
Repayment of lease liabilities .............. (2,819) (3,906)
Interest paid for lease liabilities ............ (202) (66)
NET CASH FROM FINANCING
ACTIVITIES .......................... 21,123 212,235
Net (decrease)/increase in cash and cash
equivalents ........................... (31,816) 17,523
Cash and cash equivalents at the beginning of
the year .............................. 95,942 64,661
Effect of foreign exchange rate changes ....... 5 3 5 (1,628)
Cash and cash equivalents at the end of
the year .............................. 64,661 80,556
Operating activities
For 2025, we had net cash used in operating activities of RMB137.1 million, which
was primarily attributable to our loss before tax of RMB184.9 million, adjusted by certain
non-cash and working capital items, including (i) finance costs of RMB67.0 million, and
(ii) an increase in trade and other payables of RMB28.7 million, partially offset by gain on
non-substantial modification of redemption liabilities of RMB42.1 million.
For 2024, we had net cash used in operating activities of RMB107.7 million,
primarily attributable to our loss before tax of RMB156.8 million, adjusted by certain
non-cash and working capital items, including (i) finance costs of RMB37.6 million, and
(ii) an increase in trade and other payables of RMB10.9 million.
We monitor and maintain a level of cash and cash equivalents deemed adequate to
finance our operations and mitigate the effects of fluctuations in cash flows. In view of our
net operating cash outflows throughout the Track Record Period, we plan to improve such
position by:
• Advancing our portfolio product candidates towards commercialization to
generate revenue. For our Core Product MT1013, which is undergoing the
Phase III-C01 clinical trial, we plan to complete this trial by the end of 2026
and submit the NDA in early 2027 and expect to generate inflow of cash from
its commercialization in China after obtaining NDA approval. In addition to
our Core Product, we have been optimizing our product portfolio and
propelling it from preclinical stage toward clinical studies. As we achieve
regulatory approvals for more pipeline products, we expect to generate a
steady inflow of cash from sales of pipeline products in the foreseeable future;
FINANCIAL INFORMATION
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• Forming value-accretive partnerships with pharmaceutical companies to
out-license or co-develop our pipeline products. In addition to advancing
our ongoing clinical trials of product candidates with a view to obtaining
NDA approval and achieving commercialization, we also plan to actively
pursue co-development opportunities or out-licensing arrangements for our
pipeline products, under which we may receive a share of profits from
licensees in connection with the sales and marketing of future approved
products; and
• Adopting comprehensive measures to effectively control our cost and
operating expenses. We plan to prudently monitor the growth of operating
expenses to ensure that they increase in a cost-efficient manner. We expect to
enhance our R&D efficiency by leveraging our in-house R&D team, while
seeking mutually beneficial strategic cooperations to further manage our R&D
costs. In addition, we intend to further strengthen our financial management
by securing appropriate bank credit facilities, adopting diversified payment
methods to optimize our cash flow, and maintaining a prudent level of
financial buffer as a safety margin. We also plan to enhance supplier
management to improve cost control and operational efficiency.
Investing activities
For 2025, we had net cash used in investing activities of RMB57.6 million, primarily
attributable to (i) payments of right-of-use assets of RMB16.1 million, and (ii) the purchase
of financial assets at FVTPL of RMB391.5 million, partially offset by the redemption on
maturity of financial assets at FVTPL of RMB351.8 million.
For 2024, we had net cash from investing activities of RMB54.8 million, primarily
attributable to (i) the redemption on maturity of financial assets at FVTPL of RMB690.9
million, and (ii) the withdrawal of term deposits of RMB80.0 million, partially offset by (a)
the purchase of financial assets at FVTPL of RMB634.9 million, and (b) the placement of
term deposits of RMB90.0 million.
Financing activities
For 2025, we had net cash from financing activities of RMB212.2 million, primarily
attributable to the proceeds from issue of shares of RMB235.5 million, partially offset by
the purchase of additional interest in a subsidiary from Dr. Wang Bing of RMB28.3 million.
For 2024, we had net cash from financing activities of RMB21.1 million, primarily
attributable to drawdown of bank borrowings of RMB25.5 million, partially offset by the
repayment of lease liabilities of RMB2.8 million.
FINANCIAL INFORMATION
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CASH OPERATING COSTS
The following table sets forth key information relating to our cash operating costs
for the years indicated:
For the Year Ended
December 31,
2024 2025
RMB’000 RMB’000
Costs relating to research and
development of our Core Product
Staff costs and welfare expenses ............ 13,984 18,977
Clinical trial and testing expenses .......... 27,321 31,952
Raw material expenses ................... 5,961 5,394
Pre-clinical trial and other R&D expenses .... 3,686 4,811
Others ................................ 2 4 9 1 3 4
Subtotal .............................. 51,201 61,268
Costs relating to research and
development of our other drug candidates
Staff costs and welfare expenses ............ 14,131 16,772
Clinical trial and testing expenses .......... 8,382 12,007
Raw material expenses ................... 5,345 6,944
Pre-clinical trial and other R&D expenses .... 9,288 5,199
Others ................................ 8 0 6 4 0 7
Subtotal .............................. 37,952 41,329
Workforce employment costs .............. 11,220 14,672
T otal ................................. 100,373 117,269
WORKING CAPITAL
Our Directors are of the view that, taking into account the financial resources
available to us, including cash and cash equivalents, and the estimated net proceeds from
the Global Offering, we have sufficient working capital to cover at least 125% of our costs,
including R&D expenses, administrative expenses, other operating expenses and
necessary capital expenditure, for at least the next 12 months from the date of this
prospectus.
Our cash burn rate refers to the average monthly (i) net cash used in operating
activities, (ii) capital expenditures, and (iii) lease payments. We estimate that we will
receive net proceeds of approximately HK$989.3 million, equivalent to RMB860.7 million,
after deducting the underwriting fees and expenses payable by us in the Global Offering,
assuming an Offer Price of HK$18.2 per Offer Share, being the low-end of the indicative
Offer Price range of HK$18.2 to HK$21.0 per Offer Share set out in this prospectus, and
assuming the Over-allotment Options is not exercised. Assuming an average cash burn
rate going forward of 1.5 times of the level for 2025, we estimate that our cash and cash
equivalents and term deposits of RMB202.5 million as of April 30, 2026 will be able to
maintain our financial viability for approximately 10 months or, if we take into account
10% of the estimated net proceeds from the Global Offering (namely, the portion used for
working capital and general corporate purposes), approximately 15 months or, if we also
take into account the estimated net proceeds from the Global Offering, approximately 54
months. Our Directors will continue to monitor our working capital, cash flows and our
business development progress.
FINANCIAL INFORMATION
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INDEBTEDNESS
The following table sets forth the breakdown of our indebtedness as of the dates
indicated:
As at December 31,
As at
April 30,
2024 2025 2026
RMB’000 RMB’000 RMB’000
(Unaudited)
Current
Lease liabilities ............. 2,259 1,399 762
Amount due to the Controlling
Shareholder .............. 28,333 – –
Bank borrowings ........... 1,760 48,100 –
Redemption liabilities ....... – 134,281 139,648
Subtotal .................... 32,352 183,780 140,410
Non-current
Redemption liabilities ....... – 1,024,737 1,062,132
Lease liabilities ............. 2 8 0 2 0 2 –
Bank borrowings ........... 42,253 – –
Subtotal .................... 42,533 1,024,939 1,062,132
T otal ....................... 74,885 1,208,719 1,202,542
As at December 31
As at
April 30,
2024 2025 2026
RMB’000 RMB’000 RMB’000
(Unaudited)
Redemption liabilities ......... – 1,159,018 1,201,780
Lease liabilities .............. 2,539 1,601 762
Bank borrowings ............. 44,013 48,100 –
Amount due to the Controlling
Shareholder ................ 28,333 – –
T otal ....................... 74,885 1,208,719 1,202,542
Redemption Liabilities
As of December 31, 2024, December 31, 2025 and April 30, 2026, our redemption
liabilities, which were unsecured and unguaranteed, amounted to nil, RMB1,159 million
and RMB1,202 million, respectively. Our redemption liabilities primarily represent our
obligation to purchase our equity instruments, which is conditional on the exercise by
certain investors of the right to require their investments to be redeemed. We recognized
such obligation to the investors as financial liabilities measured initially at fair value
(representing the present value of the expected cash flows for settling the related
obligations if these rights are exercised by the investors) and subsequently at amortized
cost with interest charged in finance costs. See Note 25 to the Accountants’ Report in
Appendix I to this prospectus.
FINANCIAL INFORMATION
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Lease Liabilities
Our lease liabilities are in relation to properties that we leased for our business
operations. We recognized lease liabilities in respect of all of our operating leases, except
for short-term leases and leases of low-value assets.
As of December 31, 2024, December 31, 2025 and April 30, 2026, we had lease
liabilities of:
• RMB1.2 million, RMB0.7 million and RMB0.4 million, respectively, that were
unsecured and unguaranteed; and
• RMB1.3 million, RMB0.9 million and RMB0.4 million, respectively, that were
secured by rental deposits and unguaranteed.
Lease liabilities are measured at the present value of the lease payments that are not
yet paid. The weighted average incremental borrowing rates applied to lease liabilities
range from 2.5% to 4.7% as of December 31, 2024, 3.5% to 4.5% as of December 31, 2025 and
3.5% to 4.5% as of April 30, 2026.
Bank Borrowings
During the Track Record Period, we had bank borrowings from the Bank of China.
They increased from RMB44.0 million as of December 31, 2024 to RMB48.1 million as of
December 31, 2025, primarily due to the drawdown of bank borrowings of RMB5.1 million
and the repayment of RMB1.0 million in 2025. The drawdown was mainly to support our
business operations including R&D activities. The interest rate was 115 basis points below
the one-year loan prime rate in the PRC and reset every twelve months. These borrowings
were credit-based and were not subject to pledge, mortgage, guarantee or other security
interest.
During the Track Record Period and up to the Latest Practicable Date, we had not
breached any material covenants or undertakings under the loan agreements we entered
into with the Bank of China, and there was no default in the repayment of borrowings.
As of April 30, 2026, the latest practicable date for determining our indebtedness,
we had repaid all our bank borrowings and we had RMB477.3 million of committed
unutilized bank facilities. Since April 30, 2026 and up to the Latest Practicable Date, there
had been no material change in our indebtedness.
During the Track Record Period and up to the Latest Practicable Date, we had not
had any guarantee or any pledge over key assets.
During the Track Record Period and up to the Latest Practicable Date, we had not
experienced any difficulties in obtaining additional debt or equity financing.
CONTINGENT LIABILITIES
During the Track Record Period, we had not had any contingent liabilities. We
confirm that up to the Latest Practicable Date, there had been no material changes or
arrangements to our contingent liabilities.
Saved as otherwise disclosed above, as of April 30, 2026, being the latest practicable
date for determining our indebtedness, we did not have any other loan agreed to be
issued, bank overdrafts, loans and other similar indebtedness, liabilities under
acceptances or acceptance credits or hire purchase commitments, debentures, mortgages,
charges, guarantees or other material contingent liabilities.
OFF-BALANCE SHEET COMMITMENTS AND ARRANGEMENTS
As of the Latest Practicable Date, we had not entered into any off-balance sheet
transactions.
FINANCIAL INFORMATION
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RELATED PARTY TRANSACTIONS
During the Track Record Period, we entered into several transactions with our
related parties: (i) our Company entered into an agreement with Dr. Wang Bing to acquire
his equity interest in Xi’an Biocare in August 2023; as of December 31, 2024 and 2025, the
balance was RMB28.3 million and nil, respectively, (ii) Zhongrui Zekang, on behalf of our
Company, collected employees’ payments of exercise or subscription prices for share
options or shares under our share incentive scheme; as of December 31, 2024 and 2025, the
balance was RMB0.7 million and RMB1.1 million, respectively; as of the Latest Practicable
Date, the amount due from Zhongrui Zekang had been settled, and (iii) we recognized
RMB7.0 million and RMB10.5 million in 2024 and 2025, respectively, for the compensation
of our key management personnel. See Notes 23 and 34 to the Accountants’ Report in
Appendix I to this prospectus for a detailed description of our related party transactions.
Our Directors believe that our transactions with related parties during the Track Record
Period were conducted on an arm’s length basis, and they did not distort our results of
operations or make our historical results not reflective of our future performance.
KEY FINANCIAL RATIOS
The following table sets forth the current ratio of our Group as of the dates
indicated:
As of December 31,
2024 2025
Current ratio (1) ......................... 2 . 4 1 . 0
Note:
(1) Current ratio equals current assets divided by current liabilities as of the same date.
Our current ratio decreased from 2.4 as of December 31, 2024 to 1.0 as of December
31, 2025, primarily due to an increase in our current liabilities resulting from (i) the
classification of certain redemption liabilities as current liabilities, and (ii) part of the
non-current portion of our bank borrowings becoming current. For more details, see “—
Discussion of Certain Selected Items from the Consolidated Statements of Financial
Position” in this section.
QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT FINANCIAL RISK
We are exposed to market risk, credit risk and impairment assessment, and liquidity
risk arising in the normal course of our business. We manage and monitor these exposures
to ensure appropriate measures are implemented on a timely and effective manner.
Further details of our financial risk management are set out in Note 32 to the Accountants’
Report in Appendix I to this prospectus.
Market Risk
Currency Risk
Certain financial assets and liabilities are denominated in foreign currencies of
respective group entities which are exposed to foreign currency risk. We currently do not
have a foreign currency hedging policy. However, our management monitors foreign
exchange exposure and will consider hedging significant foreign currency exposure
should the need arise.
Interest Rate Risk
We are exposed to fair value interest rate risk in relation to term deposits,
redemption liabilities and lease liabilities. We are also exposed to cash flow interest rate
risk in relation to variable-rate bank balances and variable-rate bank borrowings. The cash
flow interest rate risk is mainly concentrated on the fluctuation of interest rates on bank
balances and bank borrowings. As our management considers that the exposure of cash
flow interest rate risk arising from variable-rate bank balances and variable-rate bank
borrowings is insignificant, therefore no sensitivity analysis on such risk has been
prepared.
Credit Risk and Impairment Assessment
Credit risk refers to the risk that our counterparties’ default on their contractual
obligations resulting in financial losses to us. Our credit risk exposures are primarily
FINANCIAL INFORMATION
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attributable to other receivables, amounts due from subsidiaries and bank balances and
term deposits. We do not hold any collateral or other credit enhancements to cover our
credit risks associated with our financial assets. We performed impairment assessment for
financial assets under expected credit loss model. For more information about our credit
risk management, maximum credit risk exposures and the related impairment assessment,
see Note 32 to the Accountants’ Report in Appendix I to this prospectus.
Liquidity Risk
In the management of the liquidity risk, we closely monitor our cash position
resulting from our operations and maintain a level of cash and cash equivalents deemed
adequate by the management to enable us to meet in full our financial obligations as they
fall due for the foreseeable future. Our management monitors the utilization of bank
borrowings and ensures compliance with loan covenants.
DIVIDEND POLICY
No dividend has been proposed, paid or declared by our Company since its
incorporation. As of the Latest Practicable Date, we did not have a formal dividend policy
or fixed dividend payout ratio. We do not have any plan to declare or pay any dividends in
the foreseeable future. The determination of whether to pay a dividend and in which
amount is based on factors the Board may deem relevant. Any dividend distribution will
also be subject to the approval of the Shareholders in the Shareholder’s meeting. Under
the PRC law and the Articles of Association, the general reserve requires annual
appropriations of 10% of after-tax profits at each year-end until the balance reaches 50% of
the relevant PRC entity’s registered capital. In view of our accumulated losses, as advised
by our PRC Legal Advisor, according to the relevant PRC laws and regulations and the
Articles of Association, we shall not declare or pay dividend until the accumulated losses
are covered by our after-tax profits and sufficient statutory common reserve are drawn in
accordance with the relevant laws and regulations, and Articles of Association.
DISTRIBUTABLE RESERVES
As of December 31, 2025, we did not have any distributable reserves.
LISTING EXPENSES
Listing expenses to be borne by us are estimated to be approximately RMB61.4
million (including underwriting commission, at the Offer Price of HK$19.60 per H Share,
being the midpoint of the indicative Offer Price range of HK$18.20 to HK$21.00 per H
Share), which represent 6.2% of the gross proceeds from the Global Offering, assuming no
Shares are issued pursuant to the Over-allotment Option. The above listing expenses are
comprised of (i) underwriting-related expenses, including sponsor fee and underwriting
commission, of RMB39.6 million, and (ii) non-underwriting-related expenses of RMB21.8
million, including (a) the legal advisors and the reporting accountants’ expenses of
RMB13.0 million, and (b) other fees and expenses of RMB8.8 million. Approximately
RMB19.4 million of our listing expenses shall be charged to our consolidated statements of
profit or loss, among which, approximately RMB9.9 million has been charged during the
Track Record Period, and approximately RMB42.0 million is expected to be deducted from
equity upon 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 STATEMENT OF ADJUSTED CONSOLIDATED NET
TANGIBLE ASSETS (LIABILITIES)
For details, please see “Unaudited Pro Forma Financial Information” in Appendix II
to this prospectus.
NO MATERIAL ADVERSE CHANGE
Our Directors confirm that there has been no material adverse change in our
financial or trading position or prospects since December 31, 2025, and up to the date of
this prospectus and there has been no event since December 31, 2025, and up to the date of
this prospectus which would materially affect the information shown in our consolidated
financial statements included in the Accountants’ Report in Appendix I to this prospectus.
DISCLOSURE REQUIRED UNDER THE LISTING RULES
Our Directors confirm that as of the Latest Practicable Date, there was no
circumstance that would give rise to a disclosure requirement under Rules 13.13 to 13.19
of the Listing Rules.
FINANCIAL INFORMATION
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FUTURE PLANS
See “Business — Our Strategies” for a detailed description of our future plans.
USE OF PROCEEDS
We estimate that we will receive net proceeds of approximately HK$1,067.2 million
after deducting the underwriting fees and expenses payable by us in the Global Offering
assuming an Offer Price of HK$19.60 per Offer Share, being the mid-point of the indicative
Offer Price range of HK$18.20 to HK$21.00 per Offer Share set out in this prospectus. We
intend to use the net proceeds from the Global Offering for the following purposes:
(i) approximately 39.1%, or HK$417.3 million, will be used for ongoing and planned
clinical trials and planned commercial launch of our Core Product, of which:
(a) approximately 7.5%, or HK$80.0 million, will be used for the Phase III-C01
clinical trial of MT1013 for the treatment of CKD-SHPT. We initiated the Phase
III clinical trial for this indication in China in July 2025 and plan to enroll
approximately 424 subjects. As of the Latest Practicable Date, all 424 planned
subjects had been enrolled. We expect to complete this trial by the end of 2026
and submit the NDA in early 2027;
(b) approximately 5.9%, or HK$63.0 million, will be used for the planned
commercial launch of MT1013 for the treatment of CKD-SHPT, covering fees
related to registration with relevant regulatory agencies and production of
MT1013. We plan to commence commercialization activities in early 2028 after
obtaining NDA approval;
For more information of our commercialization strategy, see “Business —
Commercialization”.
(c) approximately 17.0%, or HK$181.4 million, will be used for the indication
expansion of MT1013, of which:
• approximately 14.5%, or HK$154.7 million, will be used for clinical
trials of MT1013 for the treatment of CKD-MBD with Osteoporosis in
China. We have completed Phase II clinical trial of MT1013 for the
indication of CKD-SHPT, and plan to leverage data collected from
respective trials to seek IND approvals from competent regulatory
authorities to conduct Phase III clinical trial of MT1013 for the expanded
indication of CKD-MBD with Osteoporosis. We expect to initiate the
Phase III clinical trial for this indication in early 2028;
• approximately 2.5%, or HK$26.7 million will be used for clinical trials of
MT1013 for the treatment of CKD-SHPT not on Dialysis in China. We
expect to submit an IND application for the clinical trial of MT1013 for
the treatment of CKD-SHPT not on Dialysis by the end of 2027.
(d) approximately 8.7%, or HK$92.8 million, will be used for other ongoing and
planned clinical trials of MT1013 to further evaluate its potential therapeutic
benefits and administration methods for the treatment of CKD-SHPT, of
which:
• approximately 0.3%, or HK$3.2 million will be used for the Phase I-C03
clinical trial of MT1013 in China, which was initiated in July 2025. As of
the Latest Practicable Date, all subjects completed the trial;
• approximately 4.4%, or HK$47.0 million will be used for the Phase
II-C02 clinical trial of MT1013 in China, which was initiated in March
2024 with all 350 subjects enrolled as of the Latest Practicable Date, and
is expected to be completed by end of 2026;
• approximately 0.5%, or HK$5.3 million will be used for the Phase II-C03
clinical trial of MT1013 in China, which was initiated in November 2024;
• approximately 3.5%, or HK$37.4 million will be used for the Phase II
clinical trial of MT1013 for the treatment of CKD-SHPT in the U.S. The
IND was reactivated on February 13, 2026, and approval from the FDA
was obtained on March 20, 2026 to proceed to a Phase II clinical trial.
FUTURE PLANS AND USE OF PROCEEDS
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For more information of our future development plans, see “Business — Our Drug
Candidates — Our Core Product MT1013 — Clinical Development Plan”.
(ii) approximately 36.3%, or HK$387.4 million, will be used for ongoing and planned
clinical trials and planned commercial launch of our Key Products, of which:
(a) approximately 6.8%, or HK$72.6 million, will be used for ongoing and
planned clinical trials of XTL6001, of which:
• approximately 3.5%, or HK$37.4 million, will be used for clinical trials
of XTL6001 for the treatment of chronic weight management in obese or
overweight populations in China, including approximately 1.5%, or
HK$16.0 million for the Phase II clinical trial of XTL6001, and
approximately 2.0%, or HK$21.3 million for the Phase III clinical trial of
XTL6001. The Phase II trial in China is expected to be initiated in the
third quarter of 2026 and completed in the third quarter of 2027; and
• approximately 3.3%, or HK$35.2 million, will be used for clinical trials
of XTL6001 for the treatment of proteinuric CKD and MASH in China,
including approximately 0.9%, or HK$9.6 million, for the Phase II
clinical trial of XTL6001 for Proteinuric CKD, which we expect to
initiate in China in mid-2027, approximately 1.5%, or HK$16.0 million,
for the Phase III clinical trial of XTL6001 for proteinuric CKD, as well as
approximately 0.9%, or HK$9.6 million, for the Phase II clinical trial of
XTL6001 for the treatment of MASH, for which we expect to submit an
IND application in early 2027;
For more information of our future development plans, see “Business — Our
Drug Candidates — Our Key Product XTL6001 — Clinical Development
Plan”.
(b) approximately 14.5%, or HK$154.7 million, will be used for ongoing and
planned clinical trials of MT1002, of which:
• approximately 6.5%, or HK$69.4 million, will be used for the Phase
II-C04 and IIb clinical trials of MT1002 for the treatment of ACS-PCI in
China. As of the Latest Practicable Date, five dose-exploration cohorts
have been completed, and enrollment of 26 subjects in the
dose-expansion cohort was completed. We expect to complete the Phase
II-C04 clinical trial in mid-2026 and the Phase IIb clinical trial in
mid-2028;
The Phase IIb clinical trial forms part of MT1002-II-C04 and was
conducted to further evaluate the selected dose(s) in a larger patient
population. For more information on reasons to conduct the Phase IIb
clinical trial, see “Business — Our Key Product MT1002 — Clinical Trial
Overview of MT1002 — MT1002-II-C04 PRC Phase II Efficacy Study in
ACS-PCI Patients”.
• approximately 6.9%, or HK$73.6 million, will be used for the Phase III
clinical trial of MT1002 for the treatment of ACS-PCI in China. We
expect to initiate the Phase III clinical trial in the end of 2028; and
• approximately 1.1%, or HK$11.7 million, will be used for the Phase II
clinical trials of MT1002 for the treatment of Stroke and HD in China. We
expect to commence Phase II clinical trials for the treatment of Stroke
and HD by June 2026 and July 2026, respectively.
(c) approximately 15.0%, or HK$160.1 million, will be used for ongoing and
planned clinical trials and planned commercial launch of MT200605, of which:
• approximately 1.4%, or HK$14.9 million, will be used for the Phase
II-C01 clinical trial of MT200605 for the treatment of AIS in China. As of
the Latest Practicable Date, enrollment of 360 subjects has been
completed. Looking forward, we expect to complete this trial in 2026;
• approximately 6.8%, or HK$72.6 million, will be used for the Phase III
clinical trial of MT200605 for the treatment of AIS. We expect to initiate
the Phase III clinical trial in China in mid-2027; and
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• approximately 6.8%, or HK$72.6 million, will be used for the planned
commercial launch of MT200605, covering fees related to registration
with relevant regulatory agencies and production and sales of
MT200605. We plan to commence commercialization activities for
MT200605 in 2029 after obtaining NDA approval.
(iii) approximately 14.6%, or HK$155.8 million, will be used for the R&D of our other
product candidates and technology platforms, of which:
(a) approximately 4.1%, or HK$43.8 million, will be used for the ongoing and
planned clinical trials of our other product candidates, such as MT2004,
MT1009, and MT1011, of which:
• approximately 0.9%, or HK$9.6 million, will be used for ongoing and
future clinical trials of MT1011, a universal anticoagulant reversal
agent, including approximately 0.4%, or HK$4.3 million, for the Phase
I-C02 clinical trial in China, and approximately 0.5%, or HK$5.3 million,
for the subsequent Phase II clinical trial in China;
• approximately 1.8%, or HK$19.2 million, will be used for ongoing and
future clinical trials of MT2004 for the treatment of DILI, including
approximately 0.8%, or HK$8.5 million, for the Phase II clinical trial in
China, and approximately 1.0%, or HK$10.7 million, for the subsequent
Phase III clinical trial in China;
• approximately 1.4%, or HK$14.9 million, will be used for ongoing and
future clinical trials of MT1009 for the treatment of GIOP and PMO in
China, including approximately 1.0%, or HK$10.7 million, for the Phase
I clinical trial, which we initiated in January 2026 in the PRC, and
approximately 0.4%, or HK$4.3 million, for the subsequent Phase II
clinical trial in China;
(b) approximately 3.5%, or HK$37.4 million, will be used for the R&D of novel
drug candidates, including XTL3602, XTL3710, MT1016 and XTL1018 as well
as other potential candidates. We intend to further strengthen and expand our
product pipeline for metabolic diseases, with an emphasis on kidney-related
indications, as well as cardiovascular and cerebrovascular diseases;
Specifically, approximately 1.5%, or HK$16.0 million, will be used for
kidney-related indications; approximately 1.0%, or HK$10.7 million, for other
endocrine diseases beyond kidney-related indications; and approximately
1.0%, or HK$10.7 million, for cardiovascular and cerebrovascular diseases and
other diseases. We expect to submit an IND application for XTL3710 in 2026,
for XTL3602 and MT1016 in 2027, and for XTL1018 in 2028, for advancement
into clinical development; and
For more information of our implementation plans and timelines for the novel
drug candidates proposed to be developed, see “Business — Our non-pipeline
product candidates”.
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(c) approximately 7.0%, or HK$74.7 million, will be used for the development,
upgrade and operation of our four core technology platforms, including the
recruitment of talent and the securing of intellectual property protection
through platform patenting. These platforms will serve the Core Product as
well as our other products. Among them:
• approximately 2.5%, or HK$26.7 million, will be used for
Bi-/Multi-specific Peptide and Peptide-based Macromolecule
Technology Platform — we expect to improve its ability to screen
candidate molecules with diverse molecular formats and novel
mechanisms of action, aiming to accelerate the R&D and translation of
our preclinical candidates;
• approximately 2.5%, or HK$26.7 million, will be used for
Computer-aided Peptide Design Platform — we expect to, through
collaboration with mainstream vendors, develop it into an AI-assisted
self-owned intellectual property;
• approximately 1.0%, or HK$10.7 million, will be used for Oral Peptide
Delivery Platform — we expect to, through the continuing R&D of it,
develop a proprietary patent system and advance the development of
oral formulation of drug candidates, aiming to improve patient
compliance and convenience;
• approximately 1.0%, or HK$10.7 million, will be used for Druggability
Evaluation Platform — we expect to continue optimizing and
upgrading it, further improve our in vitro biological evaluation models,
and enhance the druggability evaluation capabilities for our pipeline
products, thereby improving our overall translation efficiency.
(iv) approximately 10.0%, or HK$106.7 million, will be used for working capital and
general corporate purposes.
The above allocation of the proceeds 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. If the Offer Price is set at HK$21.00 per Share, being the high
end of the indicative Offer Price range, the net proceeds from the Global Offering will
increase by approximately HK$77.9 million. If the Offer Price is set at HK$18.20 per Share,
being the low end of the indicative Offer Price range, the net proceeds from the Global
Offering will decrease by approximately HK$77.9 million.
If the net proceeds are not immediately applied to the above purposes, we will
deposit those net proceeds into short-term interest-bearing accounts at licensed
commercial banks and/or other authorized financial institutions (as defined under the
Securities and Futures Ordinance, and the relevant applicable laws in the relevant
jurisdiction). We will make an appropriate announcement if there is any change to the
above proposed use of proceeds.
FUTURE PLANS AND USE OF PROCEEDS
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HONG KONG UNDERWRITERS
CCB International Capital Limited
China Merchants Securities (HK) Co., Limited
Jakota Securities Group Limited
Ruibang Securities Limited
Sinolink Securities (Hong Kong) Company Limited
Skyvast Securities Limited
Somerley Capital Limited
Tiger Brokers (HK) Global Limited
uSmart Securities Limited
Webull Securities Limited
Zhongtai International Securities Limited
ZMF Asset Management Limited
UNDERWRITING ARRANGEMENTS AND EXPENSES
Hong Kong Public Offering
Hong Kong Underwriting Agreement
Pursuant to the Hong Kong Underwriting Agreement, our Company is offering the
Hong Kong Offer Shares for subscription on the terms and conditions set out in this
prospectus and the Hong Kong Underwriting Agreement at the Offer Price.
Subject to (a) the Stock Exchange granting approval for the listing of, and
permission to deal in, the H Shares in issue and to be issued under the Global Offering and
such approval not having been subsequently withdrawn, revoked or withheld prior to the
commencement of trading of the H Shares on the Stock Exchange and (b) certain other
conditions set out in the Hong Kong Underwriting Agreement, the Hong Kong
Underwriters have agreed severally but not jointly to procure subscribers for, or
themselves to subscribe for, their respective applicable proportions of the Hong Kong
Offer Shares being offered which are not taken up under the Hong Kong Public Offering
on the terms and conditions set out in this prospectus and the Hong Kong Underwriting
Agreement.
The Hong Kong Underwriting Agreement is conditional on, among other things, the
International Underwriting Agreement having been executed and becoming
unconditional and not having been terminated in accordance with its terms.
Grounds for termination
The Joint Sponsors and the Sponsor-Overall Coordinators (for themselves and on
behalf of the Hong Kong Underwriters) shall be entitled, in their sole and absolute
discretion, by notice in writing to the Company, terminate the Hong Kong Underwriting
Agreement with immediate effect if, at any time at or prior to 8:00 a.m. on the Listing Date:
(1) there develops, occurs, exists or comes into effect:
(i) any change or prospective change (whether or not permanent) in the
business or in the financial or trading position of our Group taken as a
whole; or any event, circumstance, or series of events, in the nature of
force majeure (including, without limitation, any acts of government,
declaration of a local, national, regional or international emergency or
war, political change, calamity, crisis, epidemic, pandemic, outbreaks,
escalation, adverse mutation or aggravation of diseases, comprehensive
sanctions, strikes, lock-outs, other industrial actions, fire, explosion,
flooding, earthquake, tsunami, volcanic eruption, civil commotion,
riots, rebellion, public disorder, acts of war, outbreak or escalation of
hostilities (whether or not war is declared), acts of God, acts of terrorism
(whether or not responsibility has been claimed), paralysis in
government operations, interruptions or accidents or delay in
transportation) or other state of emergency in whatever form, in or
affecting, directly or indirectly the PRC, Hong Kong, Japan, the United
States, Singapore, the United Kingdom, the European Union (or any
UNDERWRITING
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member thereof), the United Kingdom, Taiwan, Cayman Islands or any
other jurisdiction relevant to our Group and/or the Global Offering
(each a “Relevant Jurisdiction” and collectively, the “Relevant
Jurisdictions”); or
(ii) any change or development involving a prospective change or
development, or any event, circumstance or series of events likely to
result in or representing any change or development involving a
prospective change, in local, national, regional or international
financial, economic, political, military, industrial, fiscal, legal,
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
Relevant Jurisdictions; or
(iii) the imposition or declaration of 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 Hong Kong Stock
Exchange, the New York Stock Exchange, the NASDAQ Global Market,
the London Stock Exchange, the Tokyo Stock Exchange, the Singapore
Exchange, the Beijing Stock Exchange, the Shenzhen Stock Exchange
and the Shanghai Stock Exchange or the trading in any securities of the
Company listed or quoted on a stock exchange or an over-the-counter
market; or
(iv) the imposition or declaration of any general moratorium on commercial
banking activities in the PRC, Hong Kong (imposed by the Financial
Secretary or the Hong Kong Monetary Authority or other competent
authority), New York (imposed at the U.S. Federal or New York State
level or by any other competent authority) or affecting any Relevant
Jurisdictions or any disruption in commercial banking or foreign
exchange trading or securities settlement or clearing services,
procedures or matters in or affecting any of the Relevant Jurisdictions;
or
(v) the commencement by any governmental authority or other regulatory
or political body or organization of any public action or investigation
against any Group company or a director, supervisor or senior
management member of any Group company in his/her capacity as
such or announcing an intention to take any such action; or
(vi) any new law, 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 (or in the interpretation
or application by any court or other competent authority of) existing
laws, in each case, in or affecting any of the Relevant Jurisdictions; or
(vii) the imposition of sanctions or export controls in whatever form, directly
or indirectly, on any Group company or any of the Warranting
Shareholders (as defined in the Hong Kong Underwriting Agreement)
or by or on any Relevant Jurisdiction, or the withdrawal of trading
privileges which existed on the date of the Hong Kong Underwriting
Agreement, in whatever form, directly or indirectly, by, or for, any of the
Relevant Jurisdictions; or
(viii) any valid demand by creditors for repayment of indebtedness of any
Group company or in respect of which any Group company is liable
prior to its stated maturity; or
(ix) any non-compliance of this prospectus (or any other documents used in
connection with the contemplated offering, allotment, issue,
subscription or sale of any of the Offer Shares), the CSRC filings or any
aspect of the Global Offering with the Listing Rules or any other
applicable Laws; or
UNDERWRITING
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(x) any change or development involving a prospective change or
amendment in or affecting taxes or exchange control, currency exchange
rates or foreign investment regulations (including, without limitation, a
material devaluation of the RMB, Hong Kong dollar or the USD against
any foreign currencies, a change in the system under which the value of
the Hong Kong dollar is linked to that of the USD or RMB is linked to
any foreign currency or currencies), or the implementation of any
exchange control, in any of the Relevant Jurisdictions or affecting an
investment in the Offer Shares; or
(xi) any litigation, dispute, legal action, claim, or regulatory or
administrative investigation or legal proceeding or action being
threatened or instigated or announced against any Group company, any
Director, any member of the senior management of the Company as
named in the prospectus or any Warranting Shareholders (as defined in
the Hong Kong Underwriting Agreement); or
(xii) any contravention by any Group company or any Director or any
member of the senior management of the Company as named in the
prospectus or any Warranting Shareholders (as defined in the Hong
Kong Underwriting Agreement) of any applicable Laws including the
Listing Rules; or
(xiii) any valid demand by creditors for repayment of indebtedness or an
order or petition for the winding up or liquidation of any Group
company or any composition or arrangement made by any Group
company with its creditors or a scheme of arrangement entered into by
any Group company or any resolution for the winding-up of any Group
company or the appointment of a provisional liquidator, receiver or
manager over all or part of the assets or undertaking of any Group
company or anything analogous thereto occurring in respect of any
Group company; or
(xiv) any change or prospective change or development, or any
materialization of any of the risks set out in the section headed “Risk
Factors” in this prospectus; or
(xv) other than with the prior written consent of the Joint Sponsors, the
Sponsor-Overall Coordinators, the Overall Coordinators and the Joint
Global Coordinators, the issue or requirement to issue by the Company
of any supplement or amendment to this prospectus or to any other
documents used in connection with the contemplated offering and sale
of the offer Shares pursuant to the Companies Ordinance, the
Companies (Winding Up and Miscellaneous Provisions) Ordinance or
the Listing Rules or any other applicable Laws or any requirement or
request of the Hong Kong Stock Exchange, the SFC and/or the CSRC; or
which, individually or in the aggregate, in the sole and absolute opinion of the
Joint Sponsors and the Sponsor-Overall Coordinators (for themselves and on
behalf of the Hong Kong Underwriters):
(a) has or will have or may have a material adverse effect on the assets,
liabilities, business, general affairs, management, prospects,
shareholders’ equity, profits, losses, results of operations, position or
condition, financial or otherwise, or performance of the Group as a
whole or to any present or prospective shareholder of the Company in
its capacity as such; or
(b) has or will have or may have a material adverse effect on the success of
the Global Offering or the level of applications under the Hong Kong
Public Offering or the level of interest under the International Offering;
or
(c) makes or will make or may make it inadvisable or inexpedient or
impracticable for the Global Offering to proceed or to market the Global
Offering or the delivery or distribution of the Offer Shares on the terms
and in the manner contemplated by the Offer Related Documents (as
defined below); or
UNDERWRITING
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(d) has or will have 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 or delaying the
processing of applications and/or payments pursuant to the Global
Offering or pursuant to the underwriting thereof; or
(2) any of the Joint Sponsors and the Sponsor-Overall Coordinators (for
themselves and on behalf of the Hong Kong Underwriters and the Capital
Market Intermediaries) shall become aware of the fact that, or have reasonable
cause to believe that:
(i) any statement contained in any of this prospectus, the disclosure
package, the preliminary offering circular, the final offering circular, the
CSRC filings, the formal notice, the Overall Coordinators
announcement and/or in any notices, announcements, advertisements,
communications or other documents (including any announcement,
circular, document or other communication pursuant to the Hong Kong
Underwriting Agreement) in connection with the Global Offering
(including any supplement or amendment thereto) (the “ Offer Related
Documents”) was, when it was issued, or has become, untrue, incorrect,
incomplete, inaccurate in any material respect or, misleading or
deceptive, or that any forecast, estimate, expression of opinion,
intention or expectation contained in any such documents is not fair and
honest and based on reasonable assumptions or reasonable grounds,
when taken as a whole; or
(ii) any matter has arisen or has been discovered which would, had it arisen
or been discovered immediately before the date of this prospectus,
constitute a material omission from, or material misstatement in, any of
Offer Related Documents (including any supplement or amendment
thereto); or
(iii) any br each of, or any event or circumstance rendering untrue or
incorrect, incomplete or misleading in any respect, any of the
Warranties; or
(iv) any event, act or omission which gives rise or is likely to give rise to any
liability of any of the Indemnifying Parties (as defined in the Hong
Kong Underwriting Agreement) pursuant to Clause 13 of the Hong
Kong Underwriting Agreement; or
(v) any breach of any of the obligations or undertakings imposed upon any
party to the Hong Kong Underwriting Agreement or the International
Underwriting Agreement (other than upon any of the Hong Kong
Underwriters or the International Underwriters); or
(vi) there is any change or development constituting or having an adverse
effect; or
(vii) that the Chairman of the Board, any Director, the chief executive officer,
the chief financial officer, or any member of senior management of the
Company named in this prospectus seeks to retire, or is removed from
office or vacating his/her office; or
(viii) 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
(ix) any Director or any member of senior management of the Company
named in this prospectus is being charged with an indictable offense or
prohibited by operation of Law or otherwise disqualified from taking
part in the management or taking directorship of a company or there is
the commencement by any governmental, political or regulatory body
of any investigation or other action against any Director or member of
senior management of the Company in his or her capacity as such or any
member of the Group or an announcement by any governmental,
political or regulatory body that it intends to commence any such
investigation or take any such action; or
UNDERWRITING
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(x) any material adverse change or effect, or any development involving a
prospective material adverse change or effect, in or affecting (1) the
assets, liabilities, business, properties, general affairs, management,
prospects, shareholders’ equity, profits, losses, results of operations,
position or condition (financial, operational or otherwise) or
performance of our Group taken as a whole, and (2) the ability of the
Company to perform its obligations under the Hong Kong
Underwriting Agreement and the International Underwriting
Agreement, including the issuance and sale of the Offer Shares, or to
consummate the transactions contemplated under this prospectus
(collectively, the “Material Adverse Change”) (whether or not
permanent); or
(xi) the approval by the Listing Committee of the Hong Kong Stock
Exchange of the listing of, and permission to deal in, the H Shares to be
issued or sold (including any additional H Shares that may be issued or
sold pursuant to the exercise of the Over-allotment Option) under the
Global Offering is refused or not granted (other than subject to
customary conditions), on or before the date of the Listing, or if granted,
the approval is subsequently withdrawn, cancelled, qualified (other
than by customary conditions), revoked or withheld; or
(xii) the CSRC filings, the notice of acceptance of the CSRC filings issued by
the CSRC and/or the published filing results in respect of the CSRC
filings on its website have been revoked, withdrawn, rejected or
terminated; or
(xiii) other than with the prior written consent of the Joint Sponsors and the
Sponsor Overall Coordinators, the issue or requirement to issue by the
Company of a supplement or amendment to the CSRC filings pursuant
to the CSRC rules or upon any requirement or request of the CSRC; or
(xiv) any non-compliance of the CSRC filings with the CSRC rules or any
other applicable Laws; or
(xv) the Company withdraws this prospectus (and/or any other Offer
Related Documents) or the Global Offering; or
(xvi) any person has withdrawn its consent to the issue of this prospectus
with the inclusion of its report, letters, and/or opinions (as the case may
be) and references to its name included in the form and context in which
it respectively appears; or
(xvii) any prohibition on the Company for whatever reason from offering,
allotting, issuing or selling any of the Offer Shares (including pursuant
to any exercise of the Over-allotment Option) pursuant to the terms of
the Global Offering; or
(xviii) any person has withdrawn or sought to withdraw its consent to being
named in any of the Offering Documents or the CSRC filings or to the
issue of any of the Offering Documents or the CSRC filings; or
(xix) an order or petition is presented for the winding-up of any Group
company, or any composition or arrangement made by any Group
company with its creditors or a scheme of arrangement entered into by
any Group company or any resolution for the winding-up of any Group
company or the appointment of a provisional liquidator, receiver or
manager over all or a material part of the material assets or undertaking
of any Group company or anything analogous thereto occurs in respect
of any Group company; or
(xx) (A) the notice of acceptance of the CSRC filings issued by the CSRC
and/or the results of the CSRC filings published on the website of the
CSRC is rejected, withdrawn, revoked or invalidated; or (B) other than
with the prior written consent of the Overall Coordinators, the issue or
requirement to issue by the Company of a supplement or amendment to
the CSRC filings pursuant to the CSRC rules or upon any requirement or
request of the CSRC; or (C) any non-compliance of the CSRC filings with
the CSRC rules or any other applicable Laws; or
UNDERWRITING
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(xxi) (A) a material portion of the orders placed or confirmed in the
book-building process has been withdrawn, terminated or cancelled or
(B) any investment commitment made by any cornerstone investors
under the Cornerstone Investment Agreements signed with such
cornerstone investors, have been withdrawn, terminated or cancelled,
or with respect to which the payment of the relevant orders and/or
investment commitment has not been received or settled in the
stipulated time and manner or otherwise.
Undertakings to the Stock Exchange pursuant to the Listing Rules
(A) Undertakings by our Company
Pursuant to Rule 10.08 of the Listing Rules, our Company has undertaken to the
Stock Exchange that it will not exercise its power to issue any further Shares, or securities
convertible into equity securities of our Company (whether or not of a class already listed)
or enter into any agreement to such an issue within six months from the Listing Date
(whether or not such issue of Shares or securities will be completed within six months
from the Listing Date), except (a) pursuant to the Global Offering and the Over-allotment
Option, (b) pursuant to any capitalization issue, capital reduction or consolidation or
sub-division of shares, or (c) under any of the circumstances provided under Rule 10.08 of
the Listing Rules.
(B) Undertakings by our group of Controlling Shareholders
Pursuant to Rule 10.07 of the Listing Rules, each of the Controlling Shareholders has
undertaken to the Stock Exchange and our Company that, he/she/she/it will not and will
procure that the relevant registered holder(s) will not:
(i) in the period commencing on the date by reference to which disclosure of
his/her/its holding of Shares is made in this prospectus and ending on the
date which is six months from the Listing Date, dispose of, nor enter into any
agreement to dispose of or otherwise create any options, rights, interests or
encumbrances in respect of, any of the Shares in respect of which he/she/it is
shown by this prospectus to be the beneficial owner; and
(ii) in the period of six months commencing on the date on which the period
referred to in paragraph (i) above expires, dispose of, nor enter into any
agreement to dispose of or otherwise create any options, rights, interests or
encumbrances in respect of, any of the Shares referred to in paragraph (i)
above if, immediately following such disposal or upon the exercise or
enforcement of such options, rights, interests or encumbrances, he/she/it
would cease to be a Controlling Shareholder of our Company (as defined in
the Listing Rules) or one of the Controlling Shareholders of our Company, or
would together with the other Controlling Shareholders, cease to be the
Controlling Shareholders of our Company (as defined in the Listing Rules), in
each case, save as permitted under the Listing Rules.
Pursuant to Note 3 to Rule 10.07(2) of the Listing Rules, each of the Controlling
Shareholders has undertaken to the Stock Exchange and our Company that, within the
period commencing on the date by reference to which disclosure of his/her/its holding of
Shares is made in this prospectus and ending on the date which is 12 months from the
Listing Date, he/she/it will:
(i) when he/she/it pledges or charges any Shares beneficially owned by him/it
in favor of an authorized institution (as defined in the Banking Ordinance
(Chapter 155 of the Laws of Hong Kong)) for a bona fide commercial loan
pursuant to Note 2 to Rule 10.07(2) of the Listing Rules, immediately inform
our Company in writing of such pledge or charge together with the number of
Shares so pledged or charged; and
(ii) when he/she/it receives indications, either verbal or written, from the
pledgee or chargee of any Shares that any of the pledged or charged Shares
will be disposed of, immediately inform our Company of such indications.
Our Company will inform the Stock Exchange in writing as soon as we have been
informed of matters referred in above by any of our Controlling Shareholders and disclose
such matters by way of announcement pursuant to the requirements under the Listing
Rules as soon as possible.
UNDERWRITING
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Undertakings pursuant to the Hong Kong Underwriting Agreement
(A) Undertakings by our Company
Our Company has undertaken to each of the Joint Sponsors, the Sponsor-Overall
Coordinators, the Overall Coordinators, the Joint Global Coordinators, the Joint
Bookrunners, the Joint Lead Managers, the CMIs and the Hong Kong Underwriters not to
(except for the offer, allotment and issue of the Offer Shares pursuant to the Global
Offering, including any exercise of the Over-allotment Option), 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”), without the prior written consent of the Joint Sponsors and the Sponsor-Overall
Coordinators (for themselves and on behalf of the Hong Kong Underwriters) and unless in
compliance with the requirements of the Listing Rules:
(i) allot, issue, sell, accept subscription for, offer to allot, issue or sell, contract or
agree to allot, issue or sell, assign, mortgage, charge, pledge, hypothecate,
lend, grant or sell any option, warrant, contract or right to subscribe for or
purchase, grant or purchase any option, warrant, contract or right to allot,
issue or sell, or otherwise transfer or dispose of or create any encumbrance
over, or agree to transfer or dispose of or create an encumbrance over, either
directly or indirectly, conditionally or unconditionally, any H Shares or any
other securities of our Company, or any interest in any of the foregoing
(including, without limitation, any securities convertible into or exchangeable
or exercisable for or that represent the right to receive, or any warrants or
other rights to purchase, any H Shares), or deposit any Shares or other
securities of our Company, 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 ownership of H Shares or any
other securities of the Company, or any interest in any of the foregoing
(including, without limitation, any securities convertible into or exchangeable
or exercisable for or that represent the right to receive, or any warrants or
other rights to purchase, any H Shares);
(iii) enter into any transaction with the same economic effect as any transaction
specified in paragraphs (i) or (ii) above; or
(iv) offer to or agree to or announce any intention to effect any transaction
specified in paragraphs (i), (ii) or (iii) above,
in each case, whether any of the transactions specified in paragraphs (i), (ii) or (iii) above
is to be settled by delivery of H Shares or other securities of the Company, or in cash or
otherwise (whether or not the issue of H Shares or such other shares or securities 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 ”), our Company enters
into any transactions specified in paragraphs (i), (ii) or (iii) above or offers or agrees to or
announces any intention to effect any such transactions, our Company shall take all
reasonable steps to ensure that it will not create a disorderly or false market in the
securities of our Company. Each of the Controlling Shareholders undertakes to each of the
Joint Sponsors, the Sponsor Overall Coordinators, the Joint Overall Coordinators, the
Joint Global Coordinators, the Joint Bookrunners, the Joint Lead Managers, the Hong
Kong Underwriters and the Capital Market Intermediaries to procure the Company to
comply with the undertakings in the Hong Kong Underwriting Agreement.
(B) Undertakings by our Controlling Shareholders
Each of the Controlling Shareholders hereby jointly and severally undertake to each
of the Company and the Joint Sponsors, the Sponsor-Overall Coordinators, the Overall
Coordinators, the Joint Global Coordinators, the Joint Bookrunners, the Joint Lead
Managers, the CMIs and the Hong Kong Underwriters that without the prior written
consent of the Joint Sponsors and the Sponsor-Overall Coordinators (for themselves and
on behalf of the Hong Kong Underwriters) or unless otherwise in compliance with the
requirements of the Listing Rules:
(i) at any time during the First Six-Month Period, it shall not, and shall procure
that the relevant registered holder(s), any nominee or trustee holding on trust
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for it shall not, (a) offer, pledge, charge, sell, offer to 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, or agree to transfer or dispose of or create an
Encumbrance over, either directly or indirectly (including by way of altering
the composition or classes of beneficiaries of any trust), conditionally or
unconditionally, any Shares or other equity securities of the Company or any
interest therein (including, without limitation, any equity securities
convertible into or exchangeable or exercisable for or that represent the right
to receive, or any warrants or other rights to purchase, any Shares or any such
other equity securities of the Company or any interest in any of the foregoing)
beneficially owned by it (the “ Relevant Securities ”); or (b) enter into any
swap or other arrangement that transfers to another, in whole or in part, any
of the economic consequences of ownership of the Relevant Securities; (c)
enter into or effect any transaction with the same economic effect as any of the
transactions referred to in sub-paragraphs (a) or (b) above; or (d) offer to or
agree to or announce any intention to enter into or effect any of the
transactions referred to in sub-paragraphs (a), (b) or (c) above, which any of
the foregoing transactions referred to in sub-paragraphs (a), (b), or (c) is to be
settled by delivery of Shares or such other equity securities of the Company or
in cash or otherwise (whether or not the issue of such Shares or other
securities will be completed within the First Six-Month Period);
(ii) at any time during the Second Six-Month Period, it shall not enter into any of
the transactions referred to in paragraph (i)(a), (b) or (c) above or offer to or
agree to or announce any intention to enter into any such transaction if,
immediately following any sale, transfer or disposal or upon the exercise or
enforcement of any option, right, interest or encumbrance pursuant to such
transaction, it would cease to be a “controlling shareholder” (as defined in the
Listing Rules) of the Company or would together with the other Controlling
Shareholders cease to be “controlling shareholders” (as defined in the Listing
Rules) of the Company;
(iii) in the event that it enters into any of the transactions specified in paragraph
(i)(a), (b) or (c) above or offers to or agrees to or announce or publicly disclose
any intention to effect any such transaction within the Second Six-Month
Period, it shall take all steps to ensure that it will not create a disorderly or
false market for any Shares or other equity securities of the Company; and
(iv) at any time during the First Six-Month Period and the Second Six-Month
Period, it shall, and shall procure that the relevant registered holder(s),
comply with all the restrictions and requirements under the Listing Rules on
the sale, transfer or disposal by it or by the registered holder(s) of any Shares
or other equity securities of the Company.
Each of the Controlling Shareholders further undertakes to each of the Company
and the Joint Sponsors, the Sponsor-Overall Coordinators, the Overall Coordinators, the
Joint Global Coordinators, the Joint Bookrunners, the Joint Lead Managers, the CMIs and
the Hong Kong Underwriters that, at any time during the First Six-Month Period and the
Second Six-Month Period, it will:
(i) when it pledges or charges any equity securities or interests in the Relevant
Securities in favour of an authorised institution pursuant to Note 2 to Rule
10.07(2) of the Listing Rules, immediately inform the Company, the Joint
Sponsors and the Sponsor-Overall Coordinators (for themselves and on behalf
of the Hong Kong Underwriters)in writing of such pledges or charges
together with the number of securities and nature of interest so pledged or
charged; and
(ii) when it receives indications, either verbal or written, from any pledgee or
chargee that any of the pledged or charged equity securities or interests in the
securities of the Company will be sold, transferred or disposed of,
immediately inform the Company, the Joint Sponsors and the Sponsor-Overall
Coordinators (for themselves and on behalf of the Hong Kong Underwriters)
in writing of such indications.
The Company shall, if required pursuant to the Listing Rules, inform the Stock
Exchange in writing as soon as practicable, when it has been informed of any of the
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matters referred to above (if any) by the Controlling Shareholders and disclose such
matters by way of an announcement to be published in accordance with the Listing Rules.
Joint Sponsors’ and Hong Kong Underwriters’ interests in our Company
Save as disclosed in this prospectus and for their respective obligations under the
Hong Kong Underwriting Agreement, as of the Latest Practicable Date, none of the Joint
Sponsors or the Hong Kong Underwriters was interested, legally or beneficially, directly
or indirectly, in any Shares or any securities of any member of our Group or had any right
or option (whether legally enforceable or not) to subscribe for or purchase, or to nominate
persons to subscribe for or purchase, any Shares or any securities of any member of our
Group.
Following the completion of the Global Offering, the Hong Kong Underwriters and
their affiliated companies may hold a certain portion of the 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, our Company expect to enter into the
International Underwriting Agreement with the International Underwriters on or around
the Price Determination Date. Under the International Underwriting Agreement and
subject to 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”.
Over-allotment Option
Our Company is expected to grant to the International Underwriters the
Over-allotment Option, exercisable by the Overall Coordinators 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 our
Company may be required to issue up to an aggregate of 8,708,000 H Shares, representing
not more than 15.0% of the number of Offer Shares initially available under the Global
Offering, 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
All Capital Market Intermediaries participating in the Global Offering will receive
an aggregate underwriting commission of 2.5% of the aggregate proceeds from the Global
Offering (including any proceeds arising from the exercise of the Over-allotment Option)
(the “Gross Proceeds”) (the “Underwriting Commission ”). In addition, the Company
may, in its sole discretion, pay to all Capital Market Intermediaries an incentive fee in an
aggregate of up to 1.5 % of the Gross Proceeds (the “ Discretionary Fee”). For any
unsubscribed Hong Kong Offer Shares reallocated to the International Offering, we will
pay the underwriting commission for such Shares to the International Underwriters (but
not the Hong Kong Underwriters).
Assuming full payment of the Discretionary Fee, the fixed fees and the discretionary
fees payable to the Underwriters represent approximately 62.5% and 37.5%, respectively,
of the aggregate fees payable to the Capital Market Intermediaries in total in connection
with the Global Offering.
The aggregate underwriting commissions and fees together with the Stock
Exchange listing fees, the SFC transaction levy, the AFRC transaction levy and the Stock
Exchange trading fee, legal and other professional fees and printing and all other
expenses relating to the Global Offering are estimated to be approximately HK$70.6
million (assuming an Offer Price of HK$19.60 per Offer Share (which is the mid-point of
the Offer Price range), the full payment of the discretionary incentive fee and the
Over-allotment Option is not exercised) and will be paid by the Company.
INDEPENDENCE OF THE JOINT SPONSORS
The Joint Sponsors satisfy the independence criteria applicable to sponsors as set
out in Rule 3A.07 of the Listing Rules.
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ACTIVITIES BY SYNDICATE MEMBERS
The underwriters of the Hong Kong Public Offering and the International Offering
(together, the “Syndicate Members ”) and their affiliates may each individually undertake
a variety of activities (as further described below) which do not form part of the
underwriting or stabilizing process.
The Syndicate Members and their affiliates are diversified financial institutions
with relationships in countries around the world. These entities engage in a wide range of
commercial and investment banking, brokerage, funds management, trading, hedging,
investing and other activities for their own account and for the account of others. In the
ordinary course of their various business activities, the Syndicate Members and their
respective affiliates may purchase, sell or hold a broad array of investments and actively
trade securities, derivatives, loans, commodities, currencies, credit default swaps and
other financial instruments for their own account and for the accounts of their customers.
Such investment and trading activities may involve or relate to assets, securities and/or
instruments of our Company and/or persons and entities with relationships with our
Company and may also include swaps and other financial instruments entered into for
hedging purposes in connection with our 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.
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 “Structure of the Global Offering”. 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
our 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.
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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 H Shares on the Stock Exchange is sponsored by the Joint
Sponsors. The Joint Sponsors have made an application on behalf of our Company to the
Stock Exchange for the listing of, and permission to deal in, the H Shares in issue and to be
issued pursuant to the Global Offering (including the additional H Shares which may be
issued pursuant to the exercise of the Over-allotment Option).
58,054,400 Offer Shares will initially be made available under the Global Offering
comprising:
(a) the Hong Kong Public Offering of initially 5,805,600 Offer Shares in Hong
Kong as described in “— The Hong Kong Public Offering” in this section; and
(b) the International Offering of initially 52,248,800 Offer Shares (subject to the
Over-allotment Option) 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 International Offering” in
this section.
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 17.5% of the total Shares in issue
immediately following the completion of the Global Offering, assuming the
Over-allotment Option is not exercised. If the Over-allotment Option is exercised in full,
the Offer Shares will represent approximately 19.6% of the total Shares in issue
immediately following the completion of the Global Offering.
References in this prospectus to applications, application monies or the procedure
for applications relate solely to the Hong Kong Public Offering.
THE HONG KONG PUBLIC OFFERING
Number of Offer Shares initially offered
Pursuant to paragraph 4.2(b) of Practice Note 18 of the Listing Rules, our Company
selected Mechanism B as its initial allocation and clawback mechanism, namely our
Company is initially offering 5,805,600 H Shares for subscription by the public in Hong
Kong at the Offer Price, representing approximately 10.0% of the total number of Offer
Shares initially available under the Global Offering with no clawback mechanism.
The Hong Kong Public Offering is open to members of the public in Hong Kong as
well as to institutional and professional investors. Professional investors generally
include brokers, dealers, companies (including fund managers) whose ordinary business
involves dealing in shares and other securities and corporate entities that regularly invest
in shares and other securities.
Completion of the Hong Kong Public Offering is subject to the conditions set out in
“— Conditions of the Global Offering” 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 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 subscription price of HK$5 million
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(excluding the brokerage, the SFC transaction levy, the AFRC transaction levy and the
Stock Exchange trading fee payable) or less. The Hong Kong Offer Shares in pool B will be
allocated on an equitable basis to applicants who have applied for Hong Kong Offer
Shares with an aggregate subscription price of more than HK$5 million (excluding the
brokerage, the SFC transaction levy, the AFRC transaction levy and the Stock Exchange
trading fee payable) and up to the total value in pool B.
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 2,902,800 Offer Shares (being 50% of the Hong Kong Offer
Shares initially available under the Hong Kong Public Offering) is liable to be rejected.
Reallocation
The Offer Shares to be offered in the Hong Kong Public Offering and the
International Offering may, in certain circumstances, be reallocated as between these
offerings at the discretion of the Overall Coordinators. Subject to the allocation cap
described in the subsequent paragraph, the Overall Coordinators may in their discretion
reallocate Offer Shares from the International Offering to the Hong Kong Public Offering
to satisfy valid applications under the Hong Kong Public Offering. In addition, if the
Hong Kong Public Offering is not fully subscribed, the Overall Coordinators will have the
discretion (but shall not be under any obligation) to reallocate to the International
Offering all or any unsubscribed Hong Kong Offer Shares in such amounts as they deem
appropriate. In each case, the additional Offer Shares reallocated to the Hong Kong Public
Offering will be allocated between Pool A and Pool B and the number of Offer Shares
allocated to the International Offering will be correspondingly reduced in such manner as
the Overall Coordinators deem appropriate.
In the event of reallocation of Offer Shares between the International Offering and
the Hong Kong Public Offering in the circumstances where (a) the International Offer
Shares are fully subscribed or oversubscribed and the Hong Kong Offer Shares are fully
subscribed or oversubscribed irrespective of the number of times; or (b) the International
Offer Shares are undersubscribed and the Hong Kong Offer Shares are fully subscribed or
oversubscribed irrespective of the number of times, then up to 2,902,400 Offer Shares may
be reallocated from the International Offering to the Hong Kong Public Offering, so that
the total number of Offer Shares available for subscription under the Hong Kong Public
Offering will increase up to 8,708,000 Offer Shares, representing approximately 15% of the
number of Offer Shares initially available under the Global Offering (before exercise of the
Over-allotment Option) in accordance with Chapter 4.14 of the Guide for New Listing
Applicants provided the final Offer Price shall be fixed at HK$18.20 per Offer Share (being
the low-end of the indicative Offer Price range stated in this prospectus) or the downward
adjusted final Offer Price if a downward Offer Price adjustment is made in accordance
with Chapter 4.14 under the Guide for New Listing Applicants. In the circumstance where
the International Offer Shares are fully subscribed or oversubscribed and the Hong Kong
Offer Shares are undersubscribed, there will be no reallocation from the International
Offering to the Hong Kong Public Offering, and no over-allocation of H Shares to the
Hong Kong Public Offering.
Given the initial allocation of the Offer Shares to the Hong Kong Public Offering and
the International Offering follows Mechanism B set out under paragraph 2 of Chapter 4.14
of the Guide for New Listing Applicants and the provision of Paragraph 4.2(b) of Practice
Note 18 of the Listing Rules, no mandatory clawback or reallocation mechanism is
required to increase the number of Offer Shares under the Hong Kong Public Offering to a
certain percentage of the total number of Offer Shares offered under the Global Offering.
In each case, the additional Offer Shares reallocated to the Hong Kong Public
Offering will be allocated between Pool A and Pool B in equal proportion and the number
of Offer Shares allocated to the International Offering will be correspondingly reduced in
such manner as the Overall Coordinators in their discretion consider appropriate.
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In the event that both the Hong Kong Public Offering and International Offering are
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.
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 may be required to pay, on
application (subject to application channels), the Offer Price of HK$21.0 per Offer Share in
addition to the brokerage, the SFC transaction levy, the AFRC transaction levy and the
Stock Exchange trading fee payable on each Offer Share, amounting to a total of
HK$4,242.36 for one board lot of 200 H Shares. Further details are set out in “How to
Apply for Hong Kong Offer Shares”.
THE INTERNATIONAL OFFERING
Number of Offer Shares initially offered
The International Offering will consist of an offering of initially 52,248,800 H Shares,
representing approximately 90.0% of the total number of Offer Shares initially available
under the Global Offering (subject to the Over-allotment Option) and approximately
15.7% of our enlarged issued share capital immediately after completion of the Global
Offering (assuming the Over-allotment Option is not exercised).
Allocation
The International Offering will include selective marketing of Offer Shares to
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
our Group and the Shareholders as a whole.
The Overall Coordinators (for themselves and 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 Overall Coordinators so as to allow them to identify the
relevant applications under the Hong Kong Public Offering and to ensure that they are
excluded from any allocation of Offer Shares under the International Offering.
Reallocation
The total number of Offer Shares to be issued or sold pursuant to the International
Offering may change as a result of the exercise of the Over-allotment Option in whole or in
part and/or any reallocation of unsubscribed Offer Shares originally included in the Hong
Kong Public Offering.
OVER-ALLOTMENT OPTION
In connection with the Global Offering, our Company is expected to grant the
Over-allotment Option to the International Underwriters, exercisable by the Overall
Coordinators (for themselves and on behalf of the International Underwriters).
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Pursuant to the Over-allotment Option, the International Underwriters will have
the right, exercisable by the Overall Coordinators (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 to require our
Company to issue up to an aggregate of 8,708,000 additional H Shares, representing not
more than 15.00% of the total number of Offer Shares initially available under the Global
Offering, at the Offer Price under the International Offering to 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 2.6% of the total Shares in issue
immediately following the completion of the Global Offering. 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 Stabilizing 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 H Shares at a level higher than
that which might otherwise prevail for a limited period after the Listing Date. However,
there is no obligation on the Stabilizing 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 Stabilizing Manager (or any person acting for it) and in what the
Stabilizing Manager reasonably regards as the best interest of our Company, (b) may be
discontinued at any time and (c) is required to be brought to an end within 30 days of the
last day for lodging applications under the Hong Kong Public Offering.
Stabilization action permitted in Hong Kong pursuant to the Securities and Futures
(Price Stabilizing) Rules of the SFO includes (a) over-allocating for the purpose of
preventing or minimizing any reduction in the market price of the H Shares, (b) selling or
agreeing to sell the H Shares so as to establish a short position in them for the purpose of
preventing or minimizing any reduction in the market price of the H Shares, (c)
purchasing, or agreeing to purchase, the H Shares pursuant to the Over-allotment Option
in order to close out any position established under paragraph (a) or (b) above, (d)
purchasing, or agreeing to purchase, any of the H Shares for the sole purpose of
preventing or minimizing any reduction in the market price of the H Shares, (e) selling or
agreeing to sell any H Shares in order to liquidate any position established as a result of
those purchases and (f) offering or attempting to do anything as described in paragraph
(b), (c), (d) or (e) above.
Specifically, prospective applicants for and investors in the Offer Shares should note
that:
(a) the Stabilizing Manager (or any person acting for it) may, in connection with
the stabilizing action, maintain a long position in the H Shares;
(b) there is no certainty as to the extent to which and the time or period for which
the Stabilizing Manager (or any person acting for it) will maintain such a long
position;
(c) liquidation of any such long position by the Stabilizing Manager (or any
person acting for it) and selling in the open market may have an adverse
impact on the market price of the H Shares;
(d) no stabilizing action can be taken to support the price of the H Shares for
longer than the stabilization period, which will begin on the Listing Date, and
is expected to expire on Saturday, July 18, 2026, being the 30th day after the
last day for lodging applications under the Hong Kong Public Offering. After
this date, when no further stabilizing action may be taken, demand for the H
Shares, and therefore the price of the H Shares, could fall;
(e) the price of the H Shares cannot be assured to stay at or above the Offer Price
by any stabilizing action; and
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(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.
Our Company will ensure or procure that an announcement in compliance with the
Securities and Futures (Price Stabilizing) Rules of the SFO will be made within seven days
of the expiration of the stabilization period.
Over-Allocation
Following any over-allocation of H Shares in connection with the Global Offering,
the Stabilizing Manager (or any person acting for it) may cover such over-allocations by,
among other methods, exercising the Over-allotment Option in full or in part, by using H
Shares purchased by the Stabilizing Manager (or any person acting for it) in the secondary
market at prices that do not exceed the Offer Price, or by a combination of these methods.
PRICING AND ALLOCATION
The Offer Price will not be more than HK$21.0 per Offer Share and is expected to be
not less than HK$18.20 per Offer Share, unless otherwise announced, as further explained
below, not later than the morning of the last day for lodging applications under the Hong
Kong Public Offering.
The International Underwriters will be soliciting from prospective investors their
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 Overall Coordinators (for themselves and 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 our Company, reduce the number of Offer Shares offered and/or the
Offer Price below that stated in this prospectus at any time on or prior to the morning of
the last day for lodging applications under the Hong Kong Public Offering. In such a case,
our Company will, as soon as practicable following the decision to make such reduction,
and in any event not later than the morning of the last day for lodging applications under
the Hong Kong Public Offering, cause to be published on the websites of our Company
and the Stock Exchange at www.micot.cn and www.hkexnews.hk , respectively, notices of
the reduction. Upon the issue of such a notice, the revised number of Offer Shares and/or
the Offer Price will be final and conclusive and the Offer Price, if agreed upon by the
Overall Coordinators (for themselves and on behalf of the Underwriters) and our
Company, will be fixed at such revised Offer Price. The Company will also, as soon as
practicable following the decision to make such change, issue a supplemental prospectus
updating investors of the change in the number of Offer Shares being offered under the
Global Offering and/or the Offer Price. Upon the issue of such a notice and supplemental
prospectus, the revised number of Offer Shares and/or the Offer Price will be final and
conclusive and the Offer Price, if agreed upon by the Overall Coordinators (for itself and
on behalf of the Underwriters) and the Company, will be fixed within such revised Offer
Price range. The Global Offering must first be canceled and subsequently relaunched on
FINI pursuant to the supplemental prospectus.
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 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.
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 “How to
Apply for Hong Kong Offer Shares — B. Publication of Results”.
STRUCTURE OF THE GLOBAL OFFERING
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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 which leads to the resulting
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 Offer Shares as prescribed under Rule 11.13 of the
Listing Rules, our Company is required to cancel the Global Offering and issue a
supplemental prospectus or a new prospectus and subsequently relaunched on FINI
pursuant to the supplemental prospectus.
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
on a conditional basis.
Our Company expects to enter into the International Underwriting Agreement
relating to the International Offering on or about the Price Determination Date.
These underwriting arrangements, including the Underwriting Agreements, are
summarized in “Underwriting”.
CONDITIONS OF THE GLOBAL OFFERING
Acceptance of all applications for Offer Shares will be conditional on:
(a) the Stock Exchange granting approval for the listing of, and permission to
deal in, the H Shares in issue and to be issued (including the additional H
Shares which may be issued pursuant to the exercise of the Over-allotment
Option under the Global Offering), on the Main Board of the Stock Exchange
and such approval not subsequently having been withdrawn, revoked or
withheld prior to the Listing Date;
(b) the execution and delivery of the International Underwriting Agreement on or
about the Price Determination Date; and
(c) the obligations of the Hong Kong Underwriters under the Hong Kong
Underwriting Agreement and the obligations of the International
Underwriters under the International Underwriting Agreement becoming and
remaining unconditional and not having been terminated in accordance with
the terms of the respective agreements,
in each case on or before the dates and times specified in the respective Underwriting
Agreements (unless and to the extent such conditions are validly waived on or before such
dates and times) and, in any event, not later than the date which is 30 days after the date
of this prospectus.
The consummation of each of the Hong Kong Public Offering and the International
Offering is conditional upon, among other things, the other offering becoming
unconditional and not having been terminated in accordance with its terms.
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 by
our Company on the websites of our Company and the Stock Exchange at www.micot.cn
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
“How to Apply for Hong Kong Offer Shares — D. Despatch/Collection of H Share
Certificates and Refund of Application Monies”. In the meantime, all application monies
will be held in separate bank account(s) with the receiving bank(s) or other bank(s) in
Hong Kong licensed under the Banking Ordinance (Chapter 155 of the Laws of Hong
Kong).
H Share certificates for the Offer Shares will only become valid evidence of title at
8:00 a.m. on Wednesday, June 24, 2026, provided that the Global Offering has become
unconditional in all respects at or before that time.
STRUCTURE OF THE GLOBAL OFFERING
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DEALINGS IN THE H SHARES
Assuming that the Hong Kong Public Offering becomes unconditional at or before
8:00 a.m. in Hong Kong on Wednesday, June 24, 2026, it is expected that dealings in the H
Shares on the Stock Exchange will commence at 9:00 a.m. on Wednesday, June 24, 2026.
The H Shares will be traded in board lots of 200 H Shares each and the stock code of
the H Shares will be 2335.
STRUCTURE OF THE GLOBAL OFFERING
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IMPORTANT NOTICE TO INVESTORS OF HONG KONG OFFER SHARES
FULLY ELECTRONIC APPLICATION PROCESS
The Company has adopted a fully electronic application process for the Hong
Kong Public Offering and below are the procedures for application.
This document is available at the website of the Stock Exchange at
http://www.hkexnews.hk/ under the “HKEXnews > New Listings > New Listing
Information” section, and the Company’s website at www.micot.cn.
The contents of this document are identical to the prospectus as registered with
the Registrar of Companies in Hong Kong pursuant to Section 342C of the Companies
(Winding Up and Miscellaneous Provisions) Ordinance.
A. APPLICATION FOR HONG KONG OFFER SHARES
1. Who Can Apply
You can apply for Hong Kong Offer Shares if you or the person(s) for whose benefit
you are applying for:
(i) are 18 years of age or older; (ii) have a Hong Kong address (for the HK eIPO White
Form service only); and (iii) are outside the United States (within the meaning of
Regulation S) or are a person described in paragraph (h)(3) of Rule 902 of Regulation S.
Unless permitted by the Listing Rules or a waiver and/or consent has been granted
by the Stock Exchange to the Company, 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 its close associates; or
• are a Director or any of his/her close associates.
2. Application Channels
The Hong Kong Public Offering period will begin at 9:00 a.m. on Monday, June
15, 2026 and end at 12:00 noon on Thursday, June 18, 2026 (Hong Kong time).
To apply for Hong Kong Offer Shares, you may use one of the following application
channels:
Application Channel Platform T arget Investors Application Time
HK eIPO White Form
service ........
www.hkeipo.hk Applicants who would like to
receive a physical H Share
certificate. Hong Kong Offer
Shares successfully applied for
will be allotted and issued in
your own name.
From 9:00 a.m. on Monday, June
15, 2026 until 11:30 a.m. on
Thursday, June 18, 2026 and the
latest time for completing full
payment of application monies
in respect of such applications
will be 12:00 noon on Thursday,
June 18, 2026.
HKSCC EIPO channel . Your broker or custodian who is a
HKSCC Participant will submit
electronic application
instruction on your behalf
through HKSCC’s FINI system
in accordance with your
instruction.
Applicants who would not like to
receive a physical H Share
certificate. Hong Kong Offer
Shares successfully applied for
will be allotted and issued in
the name of HKSCC Nominees,
deposited directly into CCASS
and credited to your designated
HKSCC Participant’s stock
account.
Contact your broker or custodian
for the earliest and latest time
for giving such instructions, as
this may vary by broker or
custodian.
HOW TO APPLY FOR THE HONG KONG OFFER SHARES
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The HK eIPO White Form 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.
For those applying through the HK eIPO White Form service, once you complete
payment in respect of any application instructions given by you or for your benefit
through the HK eIPO White Form 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 HK eIPO
White Form service more than once and obtaining different application numbers without
effecting full payment in respect of a particular reference number will not constitute an
actual application.
If you apply through the HK eIPO White Form service, you are deemed to have
authorized the HK eIPO White Form Service Provider to apply on the terms and
conditions in this document, as supplemented and amended by the terms and conditions
of the HK eIPO White Form 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 document 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 document.
HOW TO APPLY FOR THE HONG KONG OFFER SHARES
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--- page 302 ---
3. Information Required to Apply
You 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 HK eIPO White Form service, you are required to provide a valid
e-mail address, a contact telephone number and a Hong Kong address. You 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. The number of joint applicants may not exceed four. If you are a firm,
the applicant must be in the individual members’ names.
(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 H shares in a 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.
(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:
(i) control the composition of the board of directors of the company; (ii) control more than half of
the voting power of the company; or (iii) 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).
HOW TO APPLY FOR THE HONG KONG OFFER SHARES
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For those applying through HKSCC EIPO channel, and making an application
under a power of attorney, the Company and the Overall Coordinators, as the Company’s
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: ............................. 200 Shares
Permitted number of Hong
Kong Offer Shares for
application and amount
payable on application/
successful allotment ...............
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$21.0 per H
Share.
If you are applying through the HKSCC EIPO
channel, your broker or custodian may
require you to pre-fund your application in
such amount as determined by the broker or
custodian, based on the applicable laws and
regulations in Hong Kong. You are
responsible for complying with any such
pre-funding requirement imposed by your
broker or custodian with respect to the
Hong Kong Offer Shares you applied for.
By instructing your broker or custodian to
apply for the Hong Kong Offer Shares on
your behalf through the HKSCC EIPO
channel, you (and, if you are joint
applicants, each of you jointly and severally)
are deemed to have instructed and
authorized HKSCC to cause HKSCC
Nominees (acting as nominee for the
relevant HKSCC Participants) to arrange
payment of the final Offer Price, brokerage,
SFC transaction levy, the Stock Exchange
trading fee and the AFRC transaction levy by
debiting the relevant nominee bank account
at the designated bank for your broker or
custodian.
If you are applying through the HK eIPO
White Form service, you may refer to the
table below for the amount payable for the
number of Hong Kong Offer Shares you have
selected. You must pay the respective
maximum amount payable on application in
full upon application for Hong Kong Offer
Shares.
HOW TO APPLY FOR THE HONG KONG OFFER SHARES
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--- page 304 ---
No. of Hong
Kong Offer
Shares
applied for
Maximum
Amount
payable (2) on
application/
successful
allotment
No. of Hong
Kong Offer
Shares
applied for
Maximum
Amount
payable (2) on
application/
successful
allotment
No. of Hong
Kong Offer
Shares
applied for
Maximum
Amount
payable (2) on
application/
successful
allotment
No. of Hong
Kong Offer
Shares
applied for
Maximum
Amount
payable (2) on
application/
successful
allotment
HK$ HK$ HK$ HK$
200 4,242.36 3,000 63,635.35 40,000 848,471.40 500,000 10,605,892.50
400 8,484.71 4,000 84,847.15 50,000 1,060,589.26 600,000 12,727,071.00
600 12,727.07 5,000 106,058.93 60,000 1,272,707.10 700,000 14,848,249.50
800 16,969.43 6,000 127,270.71 70,000 1,484,824.96 800,000 16,969,428.00
1,000 21,211.79 7,000 148,482.50 80,000 1,696,942.80 900,000 19,090,606.50
1,200 25,454.14 8,000 169,694.28 90,000 1,909,060.66 1,000,000 21,211,785.00
1,400 29,696.49 9,000 190,906.06 100,000 2,121,178.50 2,000,000 42,423,570.00
1,600 33,938.86 10,000 212,117.86 200,000 4,242,357.00 2,902,800 (1) 61,573,569.50
1,800 38,181.22 20,000 424,235.70 300,000 6,363,535.50
2,000 42,423.56 30,000 636,353.56 400,000 8,484,714.00
Notes:
(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
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 HK eIPO White Form Service Provider (for
applications made through the application channel of the HK eIPO White Form service) 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
You 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.
Application 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 HK eIPO White Form service, (ii)
HKSCC EIPO channel, or (iii) both channels concurrently are prohibited and will be
rejected. If you have made an application through the HK eIPO White Form service or
HKSCC EIPO channel, you or the person(s) for whose benefit you have made the
application shall not apply for any International Offer Shares.
6. T erms and Conditions of An Application
By applying for Hong Kong Offer Shares through the HK eIPO White Form 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 the
Company and/or the Overall Coordinators, as the Company’s 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;
HOW TO APPLY FOR THE HONG KONG OFFER SHARES
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--- page 305 ---
(ii) confirm that you have read and understand the terms and conditions and
application procedures set out in this document and the designated website of
the HK eIPO White Form service (or as the case may be, the agreement you
entered into with your broker or custodian), and agree to be bound by them;
(iii) (if you are applying through the HKSCC EIPO channel) agree to the
arrangements, undertakings and warranties under the participant agreement
between your broker or custodian and HKSCC and observe the General Rules
of HKSCC and the HKSCC Operational Procedures for giving application
instructions to apply for Hong Kong Offer Shares;
(iv) confirm that you are aware of the restrictions on offers and sales of Hong
Kong Offer Shares set out in this document 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 document 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 Company, the Joint Sponsors, the Overall Coordinators, the
Joint Global Coordinators, the Joint Bookrunners, the Joint Lead Managers,
the Capital Market Intermediaries, the Underwriters, any of their respective
directors, officers, employees, partners, agents, advisors and any other parties
involved in the Global Offering (the “ Relevant Persons ”), the H Share
Registrar and HKSCC will not be liable for any information and
representations not in this document 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 the Company, the
Relevant Persons, the H Share Registrar, HKSCC, HKSCC Nominees, the
Stock Exchange, the SFC and any other statutory regulatory or governmental
bodies or otherwise as required by laws, rules or regulations, for the purposes
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 H 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” in 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;
(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 the Company 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 document;
(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
HOW TO APPLY FOR THE HONG KONG OFFER SHARES
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--- page 306 ---
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 the Company and the Overall Coordinators
will rely on your declarations and representations in deciding whether or not
to allocate any Hong Kong Offer Shares to you and that you may be
prosecuted for making a false declaration;
(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 HK eIPO White Form service 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 or to the HK eIPO White Form Service Provider and (2) you have
due authority to give electronic application instructions on behalf of that
other person as its agent.
B. PUBLICATION OF RESULTS
Results of Allocation
You can check whether you are successfully allocated any Hong Kong Offer Shares
through:
Platform Date/Time
Applying through the HK eIPO White Form service or HKSCC EIPO channel:
Website . . . . . From the “Allotment Results” page at
www.hkeipo.hk/IPOResult
(alternatively: www.tricor.com.hk/ipo/result )
with a “search by ID” function.
24 hours, from 11:00 p.m. on
Tuesday, June 23, 2026 to 12:00
midnight on Monday, June 29,
2026 (Hong Kong time)
The full list of (i) wholly or partially successful
applicants using the HK eIPO White Form
service and HKSCC EIPO channel, and (ii) the
number of Hong Kong Offer Shares
conditionally allotted to them, among other
things, will be displayed at
www.hkeipo.hk/IPOResult (alternatively:
www.tricor.com.hk/ipo/result )
The Stock Exchange’s website at
www.hkexnews.hk and the Company’s
website at www.micot.cn which will provide
links to the above mentioned websites of the H
Share Registrar.
No later than 11:00 p.m. on Tuesday,
June 23, 2026
Telephone . . . +852 3691 8488 — the allocation results telephone
enquiry line provided by the H Share Registrar
between 9:00 a.m. and 6:00 p.m.
from Wednesday, June 24, 2026 to
Monday, June 29, 2026 (Hong
Kong time) on a business day
HOW TO APPLY FOR THE HONG KONG OFFER SHARES
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--- page 307 ---
For those applying through HKSCC EIPO channel, you may also check with your
broker or custodian from 6:00 p.m. on Monday, June 22, 2026 (Hong Kong time).
HKSCC Participants can log into FINI and review the allotment result from 6:00
p.m. on Monday, June 22, 2026 (Hong Kong time) on a 24-hour basis and should report any
discrepancies on allotments to HKSCC as soon as practicable.
Allocation Announcement
The Company expects 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 the Company’s website at www.micot.cn
by no later than 11:00 p.m. on Tuesday, June 23, 2026 (Hong Kong time).
C. CIRCUMSTANCES IN WHICH YOU WILL NOT BE ALLOCATED HONG KONG
OFFER SHARES
You 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:
Your 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 the Company or its agents exercise their discretion to reject your application:
The Company, the Overall Coordinators, the H Share Registrar and their respective
agents and nominees have full discretion to reject or accept any application, or to accept
only part of any application, without giving any reasons.
3. If the allocation of Hong Kong Offer Shares is void:
The allocation of Hong Kong Offer Shares will be void if the Stock Exchange does
not grant permission to list the H Shares either:
within three weeks from the closing date of the application lists; or within a longer
period of up to six weeks if the Stock Exchange notifies the Company 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. You may
refer to the paragraph headed “— A. Application 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;
• the Company or the Overall Coordinators believe that by accepting your
application, it or the Company would violate applicable securities or other
laws, rules or regulations.
5. If there is money settlement failure for allotted Offer 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
banks 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 Offer Shares, HKSCC will contact the
defaulting HKSCC Participant and its designated bank to determine the cause of failure
and request such defaulting HKSCC Participant to rectify or procure to rectify the failure.
HOW TO APPLY FOR THE HONG KONG OFFER SHARES
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--- page 308 ---
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 the Company, the Relevant Persons, the H Share Registrar and HKSCC is or will be
liable if Hong Kong Offer Shares are not allocated to you due to the money settlement
failure.
D. DESPATCH/COLLECTION OF H SHARE CERTIFICATES AND REFUND OF
APPLICATION MONIES
You will receive one H Share certificate for all Hong Kong Offer Shares allotted to
you under the Hong Kong Public Offering (except pursuant to applications made through
the HKSCC EIPO channel where the H Share certificates will be deposited into CCASS as
described below).
No temporary document of title will be issued in respect of the Hong Kong Offer
Shares. No receipt will be issued for sums paid on application.
H Share certificates will only become valid evidence of title at 8:00 a.m. on
Wednesday, June 24, 2026 (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 H Shares prior to the receipt
of H Share certificates or the H Share certificates becoming valid do so entirely at their
own risk.
The right is reserved to retain any H Share certificate(s) and (if applicable) any
surplus application monies pending clearance of application monies.
The following sets out the relevant procedures and time:
HK eIPO White Form service HKSCC EIPO channel
Despatch/collection of H Share certificate 1
For application of
equal or over
1,000,000
Hong Kong
Offer Shares .....
Collection in person from the H
Share Registrar, Tricor Investor
Services Limited, at 17/F, Far
East Finance Centre, 16
Harcourt Road, Hong Kong
Time: from 9:00 a.m. to 1:00 p.m.
on Wednesday, June 24, 2026
(Hong Kong time), or any other
place or date notified by the
Company
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 authorized
representatives must produce,
at the time of collection,
evidence of identity acceptable
to the H Share Registrar
H Share certificate(s) will be
issued in the name of HKSCC
Nominees, deposited into
CCASS and credited to your
designated HKSCC
Participant’s stock account
No action by you is required
HOW TO APPLY FOR THE HONG KONG OFFER SHARES
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--- page 309 ---
HK eIPO White Form service HKSCC EIPO channel
Note: If you do not collect your H
Share certificate(s) personally
within the time above, it/they
will be sent to the address
specified in your application
instructions by ordinary post at
your own risk
For application of less
than 1,000,000 Offer
Shares ...........
Your H Share certificate(s) will be sent
to the address specified in your
application instructions by ordinary
post at your own risk
Date: ............. T uesday, June 23, 2026
Refund mechanism for surplus application monies paid by you
Date ............. W ednesday, June 24, 2026 Subject to the arrangement between
you and your broker or custodian
Responsible party .... H Share Registrar Your broker or custodian
Application monies paid
through single bank
account ..........
HK eIPO White Form e-Auto Refund
payment instructions to your
designated bank account
Your 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
(1) Except in the event any Severe Weather Signals (as defined below) in force in Hong Kong in the morning
on Tuesday, June 23, 2026 rendering it impossible for the relevant H Share certificates to be dispatched to
HKSCC in a timely manner, the Company shall procure the H Share Registrar to arrange for delivery of
the supporting documents and H Share certificates in accordance with the contingency arrangements as
agreed between them. You may refer to “— E. Severe Weather Arrangements” in this section.
E. SEVERE WEATHER ARRANGEMENTS
The Opening and Closing of the Application Lists
The application lists will not open or close on Thursday, June 18, 2026 if, there
is/are:
a tropical cyclone warning signal number 8 or above; a black rainstorm warning;
and/or Extreme Conditions,
(collectively, “ Severe Weather Signals ”),
in force in Hong Kong at any time between 9:00 a.m. and 12:00 noon on Thursday, June 18,
2026.
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.
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
document, an announcement will be made and published on the Stock Exchange’s website
at www.hkexnews.hk and the Company’s website at www.micot.cn of the revised
timetable.
If a Severe Weather Signal is hoisted on Tuesday, June 23, 2026, the H Share Registrar
will make appropriate arrangements for the delivery of the H Share certificates to the
CCASS Depository’s service counter so that they would be available for trading on
Wednesday, June 24, 2026.
HOW TO APPLY FOR THE HONG KONG OFFER SHARES
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--- page 310 ---
If a Severe Weather Signal is hoisted on Tuesday, June 23, 2026, for application of
less than 1,000,000 Hong Kong Offer Shares, the despatch of physical H Share certificate(s)
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 Tuesday, June 23, 2026 or on
Wednesday, June 24, 2026).
If a Severe Weather Signal is hoisted on Wednesday, June 24, 2026, for application of
1,000,000 Hong Kong Offer Shares or more, physical H Share certificate(s) will be available
for collection in person at the H Share Registrar’s office after the Severe Weather Signal is
lowered or cancelled (e.g. in the afternoon of Wednesday, June 24, 2026 or on Thursday,
June 25, 2026).
Prospective investors should be aware that if they choose to receive physical H
Share certificates issued in their own name, there may be a delay in receiving the H
Share certificates.
F . ADMISSION OF THE H SHARES INTO CCASS
If the Stock Exchange grants the listing of, and permission to deal in, the Shares on
the Stock Exchange and the Company complies with the stock admission requirements of
HKSCC, the H Shares will be accepted as eligible securities by HKSCC for deposit,
clearance and settlement in CCASS with effect from the date of commencement of
dealings in the H Shares on the Stock Exchange or any other date HKSCC chooses.
Settlement of transactions between Exchange Participants is required to take place in
CCASS on the second settlement day after any trading day.
All activities under CCASS are subject to the General Rules of HKSCC and the
HKSCC Operational Procedures in effect from time to time.
All necessary arrangements have been made enabling the H Shares to be admitted
into CCASS.
You 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.
G. PERSONAL DATA
The following Personal Information Collection Statement applies to any personal
data collected and held by the Company, the H Share Registrar, the receiving bank and the
Relevant Persons about you in the same way as it applies to personal data about
applicants other than HKSCC Nominees. 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 H Share Registrar in relation to personal data and the Personal Data (Privacy)
Ordinance (Chapter 486 of the Laws of Hong Kong).
2. Reasons for the collection of 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 H
Share Registrar is accurate and up-to-date when applying for Hong Kong Offer
Shares or transferring Hong Kong Offer Shares into or out of their names or in
procuring the services of the H Share Registrar.
Failure to supply the requested data or supplying inaccurate data may result
in your application for Hong Kong Offer Shares being rejected, or in the delay or the
inability of the Company or the H Share Registrar to effect transfers or otherwise
render their services. It may also prevent or delay registration or transfers of Hong
Kong Offer Shares which you have successfully applied for and/or the despatch of
H Share certificate(s) to which you are entitled.
It is important that applicants for and holders of Hong Kong Offer Shares
inform the Company and the H Share Registrar immediately of any inaccuracies in
the personal data supplied.
HOW TO APPLY FOR THE HONG KONG OFFER SHARES
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--- page 311 ---
3. Purposes
Your personal data may be used, held, processed, and/or stored (by whatever
means) for the following purposes:
(i) processing your application and refund cheque and HK eIPO White Form
e-Auto Refund payment instruction(s), where applicable, verification of compliance
with the terms and application procedures set out in this document and announcing
results of allocation of Hong Kong Offer Shares; (ii) compliance with applicable
laws and regulations in Hong Kong and elsewhere; (iii) registering new issues or
transfers into or out of the names of the holders of the H Shares including, where
applicable, HKSCC Nominees; (iv) maintaining or updating the register of members
of the Company; (v) verifying identities of applicants for and holders of the H
Shares and identifying any duplicate applications for the H Shares; (vi) facilitating
Hong Kong Offer Shares balloting; (vii) establishing benefit entitlements of holders
of the H Shares, such as dividends, rights issues, bonus issues, etc.; (viii)
distributing communications from the Company and its subsidiaries; (ix) compiling
statistical information and profiles of the holder of the H Shares; (x) disclosing
relevant information to facilitate claims on entitlements; and (xi) any other
incidental or associated purposes relating to the above and/or to enable the
Company and the H Share Registrar to discharge their obligations to applicants and
holders of the H Shares and/or regulators and/or any other purposes to which
applicants and holders of the H Shares may from time to time agree.
4. T ransfer of personal data
Personal data held by the Company and the H Share Registrar relating to the
applicants for and holders of Hong Kong Offer Shares will be kept confidential but
the Company and the H Share Registrar may, to the extent necessary for achieving
any of the above purposes, disclose, obtain or transfer (whether within or outside
Hong Kong) the personal data to, from or with any of the following:
(i) the Company’s appointed agents such as financial advisors, receiving bank
and overseas principal share registrar; (ii) HKSCC or HKSCC Nominees, who will
use the personal data and may transfer the personal data to the H Share Registrar, in
each case for the purposes of providing its services or facilities or performing its
functions in accordance with its rules or procedures and operating FINI and CCASS
(including where applicants for the Hong Kong Offer Shares request a deposit into
CCASS); (iii) any agents, contractors or third-party service providers who offer
administrative, telecommunications, computer, payment or other services to the
Company or the H Share Registrar in connection with their respective business
operation; (iv) 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 (v) any persons or
institutions with which the holders of Hong Kong Offer Shares have or propose to
have dealings, such as their bankers, solicitors, accountants or brokers etc.
5. Retention of personal data
The Company and the H Share Registrar will keep the personal data of the
applicants 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 H Share Registrar hold their personal data, to
obtain a copy of that data, and to correct any data that is inaccurate. The Company
and the H Share Registrar have the right to charge a reasonable fee for the
processing of such requests. All requests for access to data or correction of data
should be addressed to the Company and the H Share Registrar, at their registered
address disclosed in the section headed “Corporate information” in this document
or as notified from time to time, for the attention of the company secretary, or the H
Share Registrar for the attention of the privacy compliance officer.
HOW TO APPLY FOR THE HONG KONG OFFER SHARES
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--- page 312 ---
The following is the text of a report set out on pages I-1 to I-47 received from the Company’s
reporting accountants, Deloitte Touche Tohmatsu, Certified Public Accountants, Hong Kong, for
the purpose of inclusion in this Prospectus.
ACCOUNTANTS’ REPORT ON HISTORICAL FINANCIAL INFORMATION TO THE
DIRECTORS OF SHAANXI MICOT PHARMACEUTICAL TECHNOLOGY CO., LTD.,
CCB INTERNATIONAL CAPITAL LIMITED AND CHINA MERCHANTS SECURITIES
(HK) CO., LIMITED
Introduction
We report on the historical financial information of Shaanxi Micot Pharmaceutical
Technology Co., Ltd. (ʮ̡) (the “Company”) and its
subsidiaries (together, the “ Group”) set out on pages I-3 to I-47 which comprises the
consolidated statements of financial position of the Group as at December 31, 2024 and
2025, the statements of financial position of the Company as at December 31, 2024 and
2025, and the consolidated statements of profit or loss and other comprehensive income,
the consolidated statements of changes in equity and the consolidated statements of cash
flows of the Group for each of the two years ended December 31, 2025 (the “ T rack 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-3 to I-47 forms an integral part of this report, which has been prepared
for inclusion in the prospectus of the Company dated June 15, 2026 (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 (the “ Stock Exchange”).
Directors’ responsibility for the Historical Financial Information
The directors of the Company are responsible for the preparation of the Historical
Financial Information that gives a true and fair view in accordance with the basis of
preparation set out in Note 2 to the Historical Financial Information, and for such internal
control as the directors of the Company determine is necessary to enable the preparation
of the Historical Financial Information that is free from material misstatement, whether
due to fraud or error.
Reporting accountants’ responsibility
Our responsibility is to express an opinion on the Historical Financial Information
and to report our opinion to you. We conducted our work in accordance with Hong Kong
Standard on Investment Circular Reporting Engagements 200 “Accountants’ Reports on
Historical Financial Information in Investment Circulars” issued by the Hong Kong
Institute of Certified Public Accountants (the “ HKICPA”). This standard requires that we
comply with ethical standards and plan and perform our work to obtain reasonable
assurance about whether the Historical Financial Information is free from material
misstatement.
Our work involved performing procedures to obtain evidence about the amounts
and disclosures in the Historical Financial Information. The procedures selected depend
on the reporting accountants’ judgement, including the assessment of risks of material
misstatement of the Historical Financial Information, whether due to fraud or error. In
making those risk assessment, the reporting accountants consider internal control
relevant to the entity’s preparation of the Historical Financial Information that gives a
true and fair view in accordance with the basis of preparation set out in Note 2 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
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 of the Company, as well as evaluating the overall presentation of the Historical
Financial Information.
APPENDIX I ACCOUNTANTS’ REPORT
– I-1 –


--- page 313 ---
We believe that the evidence we have obtained is sufficient and appropriate to
provide a basis for our opinion.
Opinion
In our opinion, the Historical Financial Information gives, for the purposes of the
accountants’ report, a true and fair view of the Group’s financial position as at December
31, 2024 and 2025, of the Company’s financial position as of December 31, 2024 and 2025
and of the Group’s financial performance and cash flows for the Track Record Period in
accordance with the basis of preparation set out in Note 2 to the Historical Financial
Information.
Report on matters under the Rules Governing the Listing of Securities on the Stock
Exchange and the Companies (Winding Up and Miscellaneous Provisions) Ordinance
Adjustments
In preparing the Historical Financial Information, no adjustments to the Underlying
Financial Statements as defined on page I-3 have been made.
Dividends
We refer to Note 13 to the Historical Financial Information which states that no
dividend has been declared or paid by the Company and its subsidiaries in respect of the
Track Record Period.
Deloitte T ouche T ohmatsu
Certified Public Accountants
Hong Kong
June 15, 2026
APPENDIX I ACCOUNTANTS’ REPORT
– I-2 –


--- page 314 ---
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 accountants’ report.
The consolidated financial statements of the Group for the Track Record Period, on
which the Historical Financial Information is based, have been prepared in accordance
with the accounting policies which conform with IFRS Accounting Standards as issued by
International Accounting Standards Board (the “IASB”) and were audited by us in
accordance with International Standards on Auditing as issued by the International
Auditing and Assurance Standards Board (“ Underlying Financial Statements ”).
The Historical Financial Information is presented in Renminbi (“ RMB”), which is
also the functional currency of the Company and its subsidiaries, and all values are
rounded to the nearest thousand (RMB’000) except when otherwise indicated.
CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE
INCOME
For the year ended
31 December
NOTES 2024 2025
RMB’000 RMB’000
Other income ........................ 6 4,002 2,301
Other gains and losses, net ............. 7 2,670 43,268
Administrative expenses ............... (18,812) (23,490)
Research and development expenses ..... (107,022) (130,089)
Listing expenses ..................... – (9,901)
Finance costs ........................ 8 (37,646) (67,003)
Loss before tax ....................... 9 (156,808) (184,914)
Income tax expense ................... 10 (24) -
Loss for the year ..................... (156,832) (184,914)
Other comprehensive income for the year
Item that will be reclassified to
profit or loss:
Exchange difference arising on
translation of foreign operations ....... 9 2
T otal comprehensive expense
for the year ....................... (156,823) (184,912)
APPENDIX I ACCOUNTANTS’ REPORT
– I-3 –


--- page 315 ---
For the year ended
31 December
NOTE 2024 2025
RMB’000 RMB’000
Loss for the year attributable to:
– Owners of the Company ............ (154,632) (182,507)
– Non-controlling interests ........... (2,200) (2,407)
(156,832) (184,914)
Total comprehensive expense for the year
attributable to:
– Owners of the Company ............ (154,623) (182,505)
– Non-controlling interests ........... (2,200) (2,407)
(156,823) (184,912)
Loss per share (RMB)
– Basic and diluted .................. 14 (0.66) (0.75)
APPENDIX I ACCOUNTANTS’ REPORT
– I-4 –


--- page 316 ---
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
As at December 31,
NOTES 2024 2025
RMB’000 RMB’000
NON-CURRENT ASSETS
Plant and equipment .................. 15 9,216 6,622
Right-of-use assets .................... 16 2,842 18,775
Term deposits ....................... 18 30,300 31,020
Other receivables ..................... 19 18,923 11,283
Restricted bank deposits ............... – 1,560
61,281 69,260
CURRENT ASSETS
Prepayments and other receivables ....... 19 5,513 24,186
Financial assets at fair value through profit
or loss (“FVTPL” ) .................. 20 54,611 95,209
Amount due from a related party ........ 23(d) 652 1,087
Restricted bank deposits ............... – 8 6 3
Term deposits ....................... 18 60,540 60,300
Cash and cash equivalents ............. 18 64,661 80,556
185,977 262,201
CURRENT LIABILITIES
Trade and other payables .............. 21 45,580 82,627
Bank borrowings ..................... 22 1,760 48,100
Amount due to the Controlling
Shareholder (as defined in Note 1) ....... 23(a) 28,333 –
Lease liabilities ...................... 24 2,259 1,399
Redemption liabilities ................. 25 – 134,281
77,932 266,407
NET CURRENT ASSETS (LIABILITIES) .. 108,045 (4,206)
TOTAL ASSETS LESS CURRENT
LIABILITIES ...................... 169,326 65,054
APPENDIX I ACCOUNTANTS’ REPORT
– I-5 –


--- page 317 ---
As at December 31,
NOTES 2024 2025
RMB’000 RMB’000
NON-CURRENT LIABILITIES
Bank borrowings ..................... 22 42,253 –
Lease liabilities ...................... 24 280 202
Redemption liabilities ................. 25 – 1,024,737
42,533 1,024,939
NET ASSETS (LIABILITIES) ........... 126,793 (959,885)
CAPITAL AND RESERVES
Paid-in capital/share capital ............ 29 4,985 5,474
Reserves (deficits) .................... 106,826 (977,934)
Equity (deficits) attributable to
owners of the Company .............. 1 11,811 (972,460)
Non-controlling interests ............... 14,982 12,575
TOTAL EQUITY (DEFICITS) ........... 126,793 (959,885)
APPENDIX I ACCOUNTANTS’ REPORT
– I-6 –


--- page 318 ---
STATEMENTS OF FINANCIAL POSITION OF THE COMPANY
As at December 31,
NOTES 2024 2025
RMB’000 RMB’000
NON-CURRENT ASSETS
Plant and equipment .................. 15 3,221 2,736
Right-of-use assets .................... 16 1,295 2,405
Investments in subsidiaries ............. 17 256,778 311,478
Term deposits ....................... 18 30,300 31,020
Other receivables ..................... 19 13,647 5,404
305,241 353,043
CURRENT ASSETS
Prepayments and other receivables ....... 19 2,981 23,609
Financial assets at FVTPL .............. 20 20,056 95,209
Amount due from subsidiaries .......... 23(c) 23,756 33,690
Restricted bank deposits ............... – 8 6 3
Term deposits ....................... 18 60,540 60,300
Cash and cash equivalents ............. 18 57,696 41,733
165,029 255,404
CURRENT LIABILITIES
Trade and other payables .............. 21 30,999 61,217
Bank borrowings ..................... 22 1,760 48,100
Amount due to the Controlling
Shareholder ....................... 23(a) 28,333 –
Amount due to a subsidiary ............ 23(b) – 26,500
Lease liabilities ...................... 24 1,165 1,119
Redemption liabilities ................. 25 – 134,281
62,257 271,217
NET CURRENT ASSETS (LIABILITIES) .. 102,772 (15,813)
TOTAL ASSETS LESS CURRENT
LIABILITIES ...................... 408,013 337,230
NON-CURRENT LIABILITIES
Bank borrowings ..................... 22 42,253 –
Lease liabilities ...................... 24 – 202
Redemption liabilities ................. 25 – 1,024,737
42,253 1,024,939
NET ASSETS (LIABILITIES) ........... 365,760 (687,709)
CAPITAL AND RESERVES
Paid-in capital/share capital ............ 29 4,985 5,474
Reserves (deficits) .................... 360,775 (693,183)
TOTAL EQUITY (DEFICITS) ........... 365,760 (687,709)
APPENDIX I ACCOUNTANTS’ REPORT
– I-7 –


--- page 319 ---
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
Attributable to owners of the Company
Paid-in
capital/
Share
capital
Capital
reserve
Statutory
reserve
T ranslation
reserve
Accumulated
losses
Shares
issued for
share
incentive
scheme Subtotal
Non-
controlling
interests T otal
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
(Note)
At January 1, 2024 .... 4,985 73,268 1,500 (244) (594,905) (300) (515,696) 17,182 (498,514)
Loss for the year ..... – – – – (154,632) – (154,632) (2,200) (156,832)
Other comprehensive
income for the year . . . – – – 9 – – 9 – 9
Total comprehensive income
(expense) for the year . . – – – 9 (154,632) – (154,623) (2,200) (156,823)
Conversion into a joint
stock company (Note 29) . – (267,399) (1,500) – 268,899 – – – –
Reclassification from
redemption liabilities
(Note 25) ....... – 782,130 – – – – 782,130 – 782,130
At December 31, 2024 . . . 4,985 587,999 – (235) (480,638) (300) 111,811 14,982 126,793
Loss for the year ..... – – – – (182,507) – (182,507) (2,407) (184,914)
Other comprehensive
income for the year . . . – – – 2 – – 2 – 2
Total comprehensive income
(expense) for the year . . – – – 2 (182,507) – (182,505) (2,407) (184,912)
Capital injection from
shareholders (Note 29) . . 489 235,011 – – – – 235,500 – 235,500
Recognition of redemption
liabilities (Note 25) . . . – (1,137,266) – – – – (1,137,266) – (1,137,266)
At December 31, 2025 ... 5,474 (314,256) - (233) (663,145) (300) (972,460) 12,575 (959,885)
Note:
Pursuant to the relevant laws in the People’s Republic of China (the “ PRC”), each of the entities established in
the PRC is required to transfer 10% of its profit after tax as per statutory financial statements (as determined by
the management of the group entities) to statutory reserve (including the general reserve fund and enterprise
development fund where appropriate). The general reserve fund is discretionary when the fund balance reaches
50% of the registered capital of the respective company and can be used to make up for previous years’ losses or,
expand the existing operations or can be converted into additional capital of the entity.
APPENDIX I ACCOUNTANTS’ REPORT
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CONSOLIDATED STATEMENTS OF CASH FLOWS
For the year ended
31 December
2024 2025
RMB’000 RMB’000
OPERATING ACTIVITIES
Loss before tax ............................... (156,808) (184,914)
Adjustments for: .............................
Interest income ............................. (3,235) (2,008)
Gain on fair value changes from financial
assets at FVTPL ........................... (2,028) (865)
Depreciation of plant and equipment ........... 4,853 3,463
Depreciation of right-of-use assets .............. 3,535 3,111
Gain on early termination of a lease ............ (414) –
Foreign exchange gains ...................... (228) (480)
Finance costs .............................. 37,646 67,003
Gain on non-substantial modification of
redemption liabilities ...................... – (42,081)
Operating cash flows before movements in
working capital ............................ ( 1 16,679) (156,771)
Decrease (increase) in an amount due from
a related party ............................. 4 9 (435)
Increase in prepayments and other receivables ...... (1,970) (8,598)
Increase in trade and other payables .............. 10,890 28,674
Cash used in operations ....................... (107,710) (137,130)
Income tax paid .............................. (32) –
NET CASH USED IN OPERATING ACTIVITIES ... (107,742) (137,130)
INVESTING ACTIVITIES
Interest received ............................. 10,095 1,528
Payments of right-of-use assets .................. – (16,076)
Purchase of plant and equipment ................ (1,302) (878)
Purchase of financial assets at FVTPL ............. (634,900) (391,500)
Redemption on maturity of financial assets at
FVTPL .................................... 690,910 351,767
Placement of term deposits ..................... (90,000) (60,000)
Withdrawal of term deposits .................... 80,000 60,000
Placement of restricted bank deposit ............. – (2,423)
NET CASH FROM (USED IN) INVESTING
ACTIVITIES .............................. 54,803 (57,582)
APPENDIX I ACCOUNTANTS’ REPORT
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For the year ended
31 December
2024 2025
RMB’000 RMB’000
FINANCING ACTIVITIES
Proceeds from issue of shares (Note 25) ............ – 235,500
Payments for accrued issue costs (Note 33) ......... – (1,330)
Purchase of additional interest in a subsidiary from
the Controlling Shareholder ................... – (28,333)
Proceeds from subscription price of
restricted share units ........................ – 7,268
Drawdown of bank borrowings .................. 25,463 5,147
Repayment of bank borrowings .................. (650) (1,060)
Interest paid for bank borrowings ................ (669) (985)
Repayment of lease liabilities ................... (2,819) (3,906)
Interest paid for lease liabilities ................. (202) (66)
NET CASH FROM FINANCING ACTIVITIES ..... 21,123 212,235
NET (DECREASE) INCREASE IN CASH AND
CASH EQUIV ALENTS ...................... (31,816) 17,523
CASH AND CASH EQUIV ALENTS AT
THE BEGINNING OF THE YEAR ............. 95,942 64,661
EFFECT OF FOREIGN EXCHANGE RATE
CHANGES ................................ 535 (1,628)
CASH AND CASH EQUIV ALENTS AT
THE END OF THE YEAR .................... 64,661 80,556
APPENDIX I ACCOUNTANTS’ REPORT
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NOTES TO THE HISTORICAL FINANCIAL INFORMATION
1. GENERAL
The Company was established in the PRC on January 19, 2007 as a limited liability company. On
December 9, 2024, the Company was converted into a joint stock company with limited liability under the
Company Law of the PRC, with its name changed from Shaanxi Micot Technology Co., Ltd.* (ෳ
ʮ̡) to Shaanxi Micot Pharmaceutical Technology Co., Ltd. (ʮ
̡).
The controlling shareholder (the “ Controlling Shareholder ”) of the Company is Dr. Wang Bing. Dr. Wang
Bing is also the founder of the Company.
The respective address of the registered office and the principal place of business of the Company are set
out in the section headed “Corporate Information” in the Prospectus.
The Group is a biotechnology company specializing in the discovery, development and
commercialization of bi-/multi-specific peptide drugs for the treatment of metabolic diseases as well as
cardiovascular and cerebrovascular diseases. Particulars and principal activities of the subsidiaries are
disclosed in Note 35.
The statutory financial statements of the Company for the year ended December 31, 2024 were prepared
in accordance with the Accounting Standards for Business Enterprises of the PRC and were audited by
Shaanxi Branch of China Audit Asia Pacific Certified Public Accountants LLP*ה
הCertified Public Accountants registered in the PRC. The statutory financial
statements for the year ended December 31, 2025 have not yet been issued.
The Historical Financial Information is presented in Renminbi (“ RMB”), which is also the functional
currency of the Company and its subsidiaries.
* English name for identification purpose only
2. BASIS OF PREPARATION OF HISTORICAL FINANCIAL INFORMATION
The Historical Financial Information has been prepared based on the accounting policies which conform
with IFRS Accounting Standards as issued by the IASB. For the purpose of preparation of the Historical
Financial Information, information is considered material if such information is reasonably expected to
influence decisions made by primary users. In addition, the Historical Financial Information include
applicable disclosures required by the Rules Governing the Listing of Securities on The Stock Exchange
of Hong Kong Limited (“Listing Rules”) and by the Hong Kong Companies Ordinance.
The Historical Financial Information has been prepared on the historical cost basis except for certain
financial instruments that are measured at fair values at the end of each reporting period, as explained in
the material accounting policy information set out in Note 4 below.
As at December 31, 2025, the Group and the Company had net current liabilities of RMB4,206,000 and
RMB15,813,000 and net liabilities of RMB959,885,000 and RMB687,709,000, respectively. The net current
liabilities and net liabilities primarily arise from the redemption liabilities recognized for the shares with
preferential rights amounting to RMB134,281,000 and RMB1,024,737,000 classified under current and
non-current liabilities, respectively, as at December 31, 2025, of which the key terms are detailed in Note
25.
As disclosed in Note 25, all preferential rights including the redemption right shall be suspended upon
the submission of the listing application to the Stock Exchange and be reinstated if the Company fails to
complete the application. Based on the working capital forecast of the Group for the next twelve months,
taking into account (1) the financial resources available to the Group, including cash and cash
equivalents, term deposits, restricted bank deposits and structured bank deposits on hand, (2) a
non-refundable upfront payment amounting to RMB200,000,000 received in February 2026 pursuant to
the license agreement (Note 37), and (3) the extension of the redemption date to June 30, 2027 upon the
submission of the listing application to the Stock Exchange in September 2025, the directors of the
Company believe that the Group will have sufficient cash resources to satisfy its future working capital in
the next twelve months from December 31, 2025. Accordingly, the directors of the Company consider that
it is appropriate that the Historical Financial Information is prepared on a going concern basis.
3. ADOPTION OF IFRS ACCOUNTING STANDARDS
For the purpose of preparing the Historical Financial Information for the Track Record Period, the Group
has consistently applied the accounting policies which conform with IFRS Accounting Standards, which
are effective for the accounting period beginning on January 1, 2025, throughout the Track Record Period.
APPENDIX I ACCOUNTANTS’ REPORT
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New and amendments to IFRS Accounting Standards in issue but not yet effective
At the date of this report, the following new and amendments to IFRS Accounting Standards have been
issued which are not yet effective:
Amendments to IAS 21 ........... T ranslation to a Hyperinflationary Presentation Currency 3
Amendments to IFRS 9 and IFRS 7 .... Amendments to the Classification and Measurement of
Financial Instruments 2
Amendments to IFRS 9 and IFRS 7 .... Contracts Referencing Nature dependent Electricity 2
Amendments to IFRS 10 and IAS 28 . . . Sale or Contribution of Assets between an Investor and its
Associate or Joint Venture 1
Amendments to IFRS Accounting
Standards ..................
Annual Improvements to IFRS Accounting Standards –
Volume 11 2
IFRS 18 ..................... P r esentation and Disclosure in Financial Statements 3
IFRS 20 ..................... Regulatory Assets and Regulatory Liabilities 4
1 Effective for annual periods beginning on or after a date to be determined.
2 Effective for annual periods beginning on or after January 1, 2026.
3 Effective for annual periods beginning on or after January 1, 2027.
4 Effective for annual periods beginning on or after January 1, 2029.
Except for the new IFRS Accounting Standard set out below, the directors of the Company anticipate that
the application of all the other new and amendments to IFRS Accounting Standards will have no material
impact on the consolidated financial statements in the foreseeable future.
IFRS 18 Presentation and Disclosure in Financial Statements
IFRS 18 Presentation and Disclosure in Financial Statements, which sets out requirements on presentation
and disclosures in financial statements, will replace IAS 1 Presentation of Financial Statements . This new
IFRS Accounting Standard, while carrying forward many of the requirements in IAS 1, introduces new
requirements to present specified categories and defined subtotals in the statement of profit or loss;
provide disclosures on management-defined performance measures in the notes to the financial
statements and improve aggregation and disaggregation of information to be disclosed in the financial
statements. In addition, some IAS 1 paragraphs have been moved to IAS 8 Accounting Policies, Changes in
Accounting Estimates and Errors (the title of which will be changed to Basis of Preparation of Financial
Statements upon effective of IFRS 18) and IFRS 7 Financial Instruments: Disclosures . Minor amendments to
IAS 7 Statement of Cash Flows and IAS 33 Earnings per Share are also made.
IFRS 18, and amendments to other standards, will be effective for annual periods beginning on or after
January 1, 2027, with early application permitted. The Group does not plan to early adopt IFRS 18. IFRS
18 will impact the presentation of financial statements (including aggregation and disaggregation of
items within statement of financial position and statement of comprehensive income) of the Group, but in
terms of recognition and measurement, IFRS 18 is not expected to have significant impact on the financial
performance and positions of the Group.
4. MATERIAL ACCOUNTING POLICY INFORMATION
Basis of consolidation
The Historical Financial Information incorporates the financial statements of the Company and its
subsidiaries. Control is achieved when the Company:
• has the power over the investee;
• is exposed, or has rights, to variable returns from its involvement with the investee; and
• has the ability to use its power to affect its returns.
The Group reassesses whether or not it controls an investee if facts and circumstances indicate that there
are changes to one or more of the three elements of control listed above.
Consolidation of a subsidiary begins when the Group obtains control over the subsidiary and ceases
when the Group loses control of the subsidiary. Specifically, income and expenses of a subsidiary
acquired or disposed of during the year are included in the consolidated statements of profit or loss and
other comprehensive income from the date the Group gains control until the date when the Group ceases
to control the subsidiary.
Profit or loss and each item of other comprehensive income are attributed to the owners of the Company
and to the non-controlling interests. Total comprehensive income of subsidiaries is attributed to the
owners of the Company and to the non-controlling interests even if this results in the non-controlling
interests having a deficit balance.
When necessary, adjustments are made to the financial statements of subsidiaries to bring their
accounting policies in line with the Group’s accounting policies.
All intragroup assets and liabilities, equity, income, expenses and cash flows relating to transactions
between members of the Group are eliminated in full on consolidation.
Non-controlling interests in subsidiaries are presented separately from the Group’s equity therein, which
represent present ownership interests entitling their holders to a proportionate share of net assets of the
relevant subsidiaries upon liquidation.
Investments in subsidiaries
Investments in subsidiaries are included in the statements of financial position of the Company at cost
less any accumulated impairment loss, if any.
APPENDIX I ACCOUNTANTS’ REPORT
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Leases
The Group assesses whether a contract is or contains a lease based on the definition under IFRS 16 Leases
at inception of the contract. Such contract will not be reassessed unless the terms and conditions of the
contract are subsequently changed.
The Group as a lessee
Allocation of consideration to components of a contract
For a contract that contains a lease component and one or more additional lease or non-lease components,
the Group allocates the consideration in the contract to each lease component on the basis of the relative
stand-alone price of the lease component and the aggregate stand-alone price of the non-lease
components, including non-lease building components, unless such allocation cannot be made reliably.
Short-term leases
The Group applies the short-term lease recognition exemption to leases that have a lease term of 12
months or less from the commencement date and do not contain a purchase option. Lease payments on
short-term leases are recognized as expense on a straight-line basis unless another systematic basis is
more representative of the time pattern in which economic benefits from the leased assets are consumed.
Right-of-use assets
The cost of right-of-use assets includes the amount of the initial measurement of the lease liability.
Right-of-use assets are measured at cost, less any accumulated depreciation and impairment losses, and
adjusted for any remeasurement of lease liabilities.
Right-of-use assets are depreciated on a straight-line basis over the lease term.
The Group presents right-of-use assets as a separate line item on the consolidated statements of financial
position.
Refundable rental deposits
Refundable rental deposits paid are accounted under HKFRS 9 Financial Instruments and initially
measured at fair value.
Lease liabilities
At the commencement date of a lease, the Group recognizes and measures the lease liability at the present
value of lease payments that are unpaid at that date. In calculating the present value of lease payments,
the Group uses the incremental borrowing rate at the lease commencement date if the interest rate
implicit in the lease is not readily determinable. The incremental borrowing rate depends on the term,
currency and start date of the lease and is determined based on a series of inputs including the risk-free
rate based on government bond rates.
The lease payments include fixed payments.
After the commencement date, lease liabilities are adjusted by interest accretion and lease payments.
The Group remeasures lease liabilities (and makes a corresponding adjustment to the related right-of-use
assets) whenever:
• the lease term has changed in which case the related lease liability is remeasured by discounting
the revised lease payments using a revised discount rate at the date of reassessment.
• the lease payments change due to changes in which cases the related lease liability is remeasured
by discounting the revised lease payments using the initial discount rate.
• a lease contract is modified and the lease modification is not accounted for as a separate lease (see
below for the accounting policy for “lease modifications”).
The Group presents lease liabilities as a separate line item on the consolidated statements of financial
position.
Lease modifications
The Group accounts for a lease modification as a separate lease if:
• the modification increases the scope of the lease by adding the right to use one or more
underlying assets; and
• the consideration for the leases increases by an amount commensurate with the stand-alone price
for the increase in scope and any appropriate adjustments to that stand-alone price to reflect the
circumstances of the particular contract.
For a lease modification that is not accounted for as a separate lease, the Group remeasures the lease
liability, based on the lease term of the modified lease by discounting the revised lease payments using a
revised discount rate at the effective date of the modification.
The Group accounts for the remeasurement of lease liabilities by making corresponding adjustments to
the relevant right-of-use assets.
Foreign currencies
In preparing the financial statements of each individual group entity, transactions in currencies other
than the functional currency of that entity (foreign currencies) are recognized at the rates of exchanges
prevailing on the dates of the transactions. At the end of each reporting period, monetary items
denominated in foreign currencies are retranslated at the rates prevailing at that date. Non-monetary
items carried at fair value that are denominated in foreign currencies are retranslated at the rates
prevailing on the date when the fair value was determined. Non-monetary items that are measured in
terms of historical cost in a foreign currency are not retranslated.
Exchange differences arising on the settlement of monetary items, and on the retranslation of monetary
items, are recognized in profit or loss in the period in which they arise.
APPENDIX I ACCOUNTANTS’ REPORT
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For the purposes of presenting the Historical Financial Information, the assets and liabilities of the
Group’s operations are translated into the presentation currency of the Group (RMB) using exchange
rates prevailing at the end of each reporting period. Income and expenses items are translated at the
average exchange rates for the period, unless exchange rates fluctuate significantly during that period, in
which case the exchange rates at the date of transactions are used. Exchange differences arising, if any,
are recognized in other comprehensive income and accumulated in equity under the heading of
translation reserve.
Borrowing costs
All borrowing costs are recognized in profit or loss in the period in which they are incurred as the Group
does not have any qualifying asset.
Research and development expenditure
Expenditure on research activities is recognized as an expense in the period in which it is incurred. Where
no internally generated intangible asset can be recognized, development expenditure is recognized in
profit or loss in the period in which it is incurred.
Government grants
Government grants are not recognized until there is reasonable assurance that the Group will comply
with the conditions attaching to them and that the grants will be received.
Government grants related to income that are receivable as compensation for expenses or losses already
incurred or for the purpose of giving immediate financial support to the Group with no future related
costs are recognized in profit or loss in the period in which they become receivable. Such grants are
presented under “other income”.
Employee benefits
Retirement benefit costs
The Group participates in government-managed retirement benefit schemes, which are defined
contribution schemes, pursuant to which the Group pays a fixed percentage of its staff’s wages as
contributions to the plans. Payments to defined contribution retirement benefit plans are recognized as
an expense when employees have rendered service entitling them to the contributions.
Short-term employee benefits
Short-term employee benefits are recognized at the undiscounted amount of the benefits expected to be
paid as and when employees rendered the services. All short-term employee benefits are recognized as
an expense unless another IFRS Accounting Standard requires or permits the inclusion of the benefit in
the cost of an asset.
A liability is recognized for benefits accruing to employees (such as wages and salaries) after deducting
any amount already paid.
Share-based payments
Equity-settled share-based payment transactions
Share awards/share options granted to employees and others providing similar services
Equity-settled share-based payments to employees and others providing similar services are measured at
the fair value of the equity instruments at the grant date.
The fair value of the equity-settled share-based payments determined at the grant date without taking
into consideration all non-market vesting conditions is expensed on a straight-line basis over the vesting
period, based on the Group’s estimate of equity instruments that will eventually vest, with a
corresponding increase in equity (share-based payments reserve). At the end of each reporting period,
the Group revises its estimate of the number of equity instruments expected to vest based on assessment
of all relevant non-market vesting conditions. The impact of the revision of the original estimates, if any,
is recognized in profit or loss such that the cumulative expense reflects the revised estimate, with a
corresponding adjustment to the share-based payments reserve.
When share options are exercised, the amount previously recognized in share-based payments reserve
will be transferred to capital reserve. When the share options are forfeited after the vesting date or are
still not exercised at the expiry date, the amount previously recognized in share-based payments reserve
will be transferred to accumulated losses.
When shares awards granted are vested, the amount previously recognized in shares issued for share
incentive scheme will be transferred to capital reserve.
Modification to the terms and conditions of the share-based payment arrangements
When the terms and conditions of an equity-settled share-based payment arrangement are modified, the
Group recognizes, as a minimum, the services received measured at the grant date fair value of the equity
instruments granted, unless those equity instruments do not vest because of failure to satisfy a vesting
condition (other than a market condition) that was specified at grant date. In addition, if the Group
modifies the vesting conditions (other than a market condition) in a manner that is beneficial to the
employees, for example, by reducing the vesting period, the Group takes the modified vesting conditions
into consideration over the remaining vesting period.
The incremental fair value granted, if any, is the difference between the fair value of the modified equity
instruments and that of the original equity instruments, both estimated as at the date of modification.
If the modification occurs during the vesting period, the incremental fair value granted is included in the
measurement of the amount recognized for services received over the period from modification date
until the date when the modified equity instruments are vested, in addition to the amount based on the
grant date fair value of the original equity instruments, which is recognized over the remainder of the
original vesting period.
APPENDIX I ACCOUNTANTS’ REPORT
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--- page 326 ---
If the modification reduces the total fair value of the share-based arrangement, or is not otherwise
beneficial to the employee, the Group continues to account for the original equity instruments granted as
if that modification had not occurred.
T axation
Income tax expense represents the sum of current and deferred income tax expense.
The tax currently payable is based on taxable profit for the year. Taxable profit differs from profit (loss)
before tax because of income or expense that are taxable or deductible in other years and items that are
never taxable or deductible. The Group’s liability for current tax is calculated using tax rates that have
been enacted or substantively enacted by the end of each reporting period.
Deferred tax is recognized on temporary differences between the carrying amounts of assets and
liabilities in the Historical Financial Information and the corresponding tax bases used in the
computation of taxable profit. Deferred tax liabilities are generally recognized for all taxable temporary
differences. Deferred tax assets are generally recognized for all deductible temporary differences to the
extent that it is probable that taxable profits will be available against which those deductible temporary
differences can be utilized. Such deferred tax assets and liabilities are not recognized if the temporary
difference arises from the initial recognition (other than in a business consolidation) of assets and
liabilities in a transaction that affects neither the taxable profit nor the accounting profit and at the time
of the transaction does not give rise to equal taxable and deductible temporary differences. In addition,
deferred tax liabilities are not recognized if the temporary difference arises from the initial recognition of
goodwill.
The carrying amount of deferred tax assets is reviewed at the end of each reporting period and reduced to
the extent that it is no longer probable that sufficient taxable profits will be available to allow all or part
of the asset to be recovered.
Deferred tax assets and liabilities are measured at the tax rates that are expected to apply in the period in
which the liability is settled or the asset realized, based on tax rate (and tax laws) that have been enacted
or substantively enacted by the end of each reporting period.
The measurement of deferred tax liabilities and assets reflects the tax consequences that would follow
from the manner in which the Group expects, at the end the reporting period, to recover or settle the
carrying amount of its assets and liabilities.
For the purposes of measuring deferred tax for leasing transactions in which the Group recognizes the
right-of-use assets and the related lease liabilities, the Group first determines whether the tax deductions
are attributable to the right-of-use assets or the lease liabilities.
For leasing transactions in which the tax deductions are attributable to the lease liabilities, the Group
applies IAS 12 Income Taxes requirements to the lease liabilities and the related assets separately. The
Group recognizes a deferred tax asset related to lease liabilities to the extent that it is probable that
taxable profit will be available against which the deductible temporary difference can be utilized and a
deferred tax liability for all taxable temporary differences.
Deferred tax assets and liabilities are offset when there is a legally enforceable right to set off current tax
assets against current tax liabilities and when they relate to income taxes levied to the same taxable entity
by the same taxation authority.
Current and deferred tax are recognized in profit or loss.
Plant and equipment
Plant and equipment are tangible assets that are held for use in the production or supply of goods or
services, or for administrative purposes. Plant and equipment (other than construction in progress) are
stated in the consolidated statements of financial position at cost less subsequent accumulated
depreciation and subsequent accumulated impairment losses, if any.
Plant and equipment in the course of construction for production, supply or administrative purposes are
carried at cost, less any recognized impairment loss. Costs include any costs directly attributable to
bringing the asset to the location and condition necessary for it to be capable of operating in the manner
intended by management. Depreciation of these assets, on the same basis as other plant and equipment,
commences when the assets are ready for their intended use.
Depreciation is recognized so as to write off the cost of assets less their residual values over their
estimated useful lives, using the straight-line method. The estimated useful lives, residual values and
depreciation method are reviewed at the end of each reporting period, with the effect of any changes in
estimate accounted for on a prospective basis.
An item of plant and equipment is derecognized upon disposal or when no future economic benefits are
expected to arise from the continued use of the asset. Any gain or loss arising on the disposal or
retirement of an item of plant and equipment is determined as the difference between the sales proceeds
and the carrying amount of the asset and is recognized in profit or loss.
Impairment on plant and equipment and right-of-use assets
At the end of each reporting period, the Group reviews the carrying amounts of its plant and equipment
and right-of-use assets with finite useful lives to determine whether there is any indication that those
assets have suffered an impairment loss. If any such indication exists, the recoverable amount of the
relevant asset is estimated in order to determine the extent of the impairment loss (if any).
The recoverable amount of plant and equipment and right-of-use assets are estimated individually. When
it is not possible to estimate the recoverable amount individually, the Group estimates the recoverable
amount of the cash-generating unit to which the asset belongs.
In testing a cash-generating unit for impairment, corporate assets are allocated to the relevant
cash-generating unit when a reasonable and consistent basis of allocation can be established, or
otherwise they are allocated to the smallest group of cash-generating units for which a reasonable and
APPENDIX I ACCOUNTANTS’ REPORT
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consistent allocation basis can be established. The recoverable amount is determined for the
cash-generating unit or group of cash-generating units to which the corporate asset belongs, and is
compared with the carrying amount of the relevant cash-generating unit or group of cash-generating
units. Recoverable amount is the higher of fair value less costs of disposal and value in use. In assessing
value in use, the estimated future cash flows are discounted to their present value using a pre-tax
discount rate that reflects current market assessments of the time value of money and the risks specific to
the asset (or a cash-generating unit) for which the estimates of future cash flows have not been adjusted.
If the recoverable amount of an asset (or a cash-generating unit) is estimated to be less than its carrying
amount, the carrying amount of the asset (or a cash-generating unit) is reduced to its recoverable amount.
For corporate assets or portion of corporate assets which cannot be allocated on a reasonable and
consistent basis to a cash-generating unit, the Group compares the carrying amount of a group of
cash-generating units, including the carrying amounts of the corporate assets or portion of corporate
assets allocated to that group of cash-generating units, with the recoverable amount of the group of
cash-generating units. In allocating the impairment loss, the impairment loss is allocated first to reduce
the carrying amount of any goodwill (if applicable) and then to the other assets on a pro-rata basis based
on the carrying amount of each asset in the unit or the group of cash-generating units. The carrying
amount of an asset is not reduced below the highest of its fair value less costs of disposal (if measurable),
its value in use (if determinable) and zero. The amount of the impairment loss that would otherwise have
been allocated to the asset is allocated pro rata to the other assets of the unit or the group of
cash-generating units. An impairment loss is recognized immediately in profit or loss.
Where an impairment loss subsequently reverses, the carrying amount of the asset (or cash-generating
unit or a group of cash-generating units) is increased to the revised estimate of its recoverable amount,
but so that the increased carrying amount does not exceed the carrying amount that would have been
determined had no impairment loss been recognized for the asset (or a cash-generating unit or a group of
cash-generating units) in prior years. A reversal of an impairment loss is recognized immediately in
profit or loss.
Cash and cash equivalents
Cash and cash equivalents presented on the consolidated statements of financial position include:
(a) cash, which comprises of cash on hand and demand deposits; and
(b) cash equivalents, which comprises of short-term deposits (generally with original maturity of
three months or less). Cash equivalents are held for the purpose of meeting short-term cash
commitments rather than for investment or other purposes.
For the purposes of the consolidated statements of cash flows, cash and cash equivalents consist of cash
and cash equivalents as defined above.
Financial instruments
Financial assets and financial liabilities are recognized when a group entity becomes a party to the
contractual provisions of the instrument. All regular way purchases or sales of financial assets are
recognized and derecognized on a settlement date basis. Regular way purchases or sales are purchases or
sales of financial assets that require delivery of assets within the time frame established generally by
regulation or convention in the market place concerned.
Financial assets and financial liabilities are initially measured at fair value except for trade receivables
arising from contracts with customers which are initially measured in accordance with IFRS 15 Revenue
from Contracts with Customers . Transaction costs that are directly attributable to the acquisition or issue of
financial assets and financial liabilities (other than FVTPL) are added to or deducted from the fair value
of the financial assets or financial liabilities, as appropriate, on initial recognition. Transaction costs
directly attributable to the acquisition of financial assets or financial liabilities at FVTPL are recognized
immediately in profit or loss.
The effective interest method is a method of calculating the amortized cost of a financial asset or financial
liability and of allocating interest income and interest expense over the relevant period. The effective
interest rate is the rate that exactly discounts estimated future cash receipts and payments (including all
fees and points paid or received that form an integral part of the effective interest rate, transaction costs
and other premiums or discounts) through the expected life of the financial asset or financial liability, or,
where appropriate, a shorter period, to the net carrying amount on initial recognition.
Financial assets
Classification and subsequent measurement of financial assets
Financial assets that meet the following conditions are subsequently measured at amortized cost:
• the financial asset is held within a business model whose objective is to collect contractual cash
flows; and
• the contractual terms give rise on specified dates to cash flows that are solely payments of
principal and interest on the principal amount outstanding.
All other financial assets are subsequently measured at FVTPL.
(i) Amortized cost and interest income
Interest income is recognized using the effective interest method for financial assets measured
subsequently at amortized cost. Interest income is calculated by applying the effective interest
rate to the gross carrying amount of a financial asset, except for financial assets that have
subsequently become credit-impaired (see below). For financial assets that have subsequently
become credit-impaired, interest income is recognized by applying the effective interest rate to
the amortized cost of the financial asset from the next reporting period. If the credit risk on the
credit-impaired financial instrument improves so that the financial asset is no longer
credit-impaired, interest income is recognized by applying the effective interest rate to the gross
carrying amount of the financial asset from the beginning of each reporting period following the
determination that the asset is no longer credit-impaired.
APPENDIX I ACCOUNTANTS’ REPORT
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--- page 328 ---
(ii) Financial assets at FVTPL
Financial assets that do not meet the criteria for being measured at amortized cost or designated
as fair value through other comprehensive income are measured at FVTPL.
Financial assets at FVTPL are measured at fair value at the end of each reporting period, with any
fair value gains or losses recognized in profit or loss. The net gain or loss recognized in profit or
loss includes any dividend or interest earned on the financial asset and is included in the “other
gains and losses, net” line item.
Impairment of financial assets subject to impairment assessment under IFRS 9
The Group performs impairment assessment under expected credit loss (“ ECL”) model on financial
assets (including other receivables, amount due from a related party, amounts due from subsidiaries,
restricted bank deposits, terms deposits, and cash and cash equivalents) which are subject to impairment
assessment under IFRS 9. The amount of ECL is updated at each reporting date to reflect changes in credit
risk since initial recognition.
Lifetime ECL represents the ECL that will result from all possible default events over the expected life of
the relevant instrument. In contrast, 12-month ECL (“ 12m ECL”) represents the portion of lifetime ECL
that is expected to result from default events that are possible within 12 months after the reporting date.
Assessment are done based on the Group’s historical credit loss experience, and factors that are specific
to the debtors, general economic conditions and an assessment of both the current conditions at the
reporting date as well as the forecast of future conditions.
The Group always recognizes lifetime ECL for trade-related amounts due from subsidiaries.
For all other instruments, the Group measures the loss allowance equal to 12m ECL, unless there has been
a significant increase in credit risk since initial recognition, in which case the Group recognizes lifetime
ECL. The assessment of whether lifetime ECL should be recognized is based on significant increases in
the likelihood or risk of a default occurring since initial recognition.
(i) Significant increase in credit risk
In assessing whether the credit risk has increased significantly since initial recognition, the Group
compares the risk of a default occurring on the financial instrument as at the reporting date with
the risk of a default occurring on the financial instrument as at the date of initial recognition. In
making this assessment, the Group considers both quantitative and qualitative information that is
reasonable and supportable, including historical experience and forward-looking information
that is available without undue cost or effort. Forward-looking information considered includes
the future prospects of the industries in which the Group’s debtors operate, obtained from
economic expert reports and financial analysts reports, as well as consideration of various
external sources of actual and forecast economic information that relate to the Group’s core
operations.
In particular, the following information is taken into account when assessing whether credit risk
has increased significantly:
• existing or forecast adverse changes in business, financial or economic conditions that are
expected to cause a significant decrease in the debtor’s ability to meet its debt obligations;
• an actual or expected significant deterioration in the operating results of the debtor;
• an actual or expected significant adverse change in the regulatory, economic, or
technological environment of the debtor that results in a significant decrease in the
debtor’s ability to meet its debt obligations.
Irrespective of the outcome of the above assessment, the Group presumes that the credit risk has
increased significantly since initial recognition when contractual payments are more than 30 days
past due, unless the Group has reasonable and supportable information that demonstrates
otherwise.
The Group regularly monitors the effectiveness of the criteria used to identify whether there has
been a significant increase in credit risk and revises them as appropriate to ensure that the criteria
are capable of identifying significant increase in credit risk before the amount becomes past due.
(ii) Definition of default
For internal credit risk management, the Group considers an event of default occurs when
information developed internally or obtained from external sources indicates that the debtor is
unlikely to pay its creditors, including the Group, in full (without taking into account any
collaterals held by the Group).
Irrespective of the above, the Group considers that default has occurred when a financial asset is
more than 90 days past due unless the Group has reasonable and supportable information to
demonstrate that a more lagging default criterion is more appropriate.
(iii) Credit-impaired financial assets
A financial asset is credit-impaired when one or more events that have a detrimental impact on
the estimated future cash flows of that financial asset have occurred. Evidence that a financial
asset is credit-impaired includes observable data about the following events:
(a) significant financial difficulty of the issuer or the borrower; and
(b) a breach of contract, such as a default or past due event.
APPENDIX I ACCOUNTANTS’ REPORT
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(iv) Write-off policy
The Group writes off a financial asset when there is information indicating that the counterparty
is in severe financial difficulty and there is no realistic prospect of recovery, for example, when
the counterparty has been placed under liquidation or has entered into bankruptcy proceedings.
Financial assets written off may still be subject to enforcement activities under the Group’s
recovery procedures, taking into account legal advice where appropriate. A write-off constitutes a
derecognition event. Any subsequent recoveries are recognized in profit or loss.
(v) Measurement and recognition of ECL
The measurement of ECL is a function of the probability of default, loss given default (i.e. the
magnitude of the loss if there is a default) and the exposure at default. The assessment of the
probability of default and loss given default is based on historical data and forward-looking
information. Estimation of ECL reflects an unbiased and probability-weighted amount that is
determined with the respective risks of default occurring as the weights.
Generally, the ECL is the difference between all contractual cash flows that are due to the Group
in accordance with the contract and the cash flows that the Group expects to receive, discounted
at the effective interest rate determined at initial recognition.
Interest income is calculated based on the gross carrying amount of the financial asset unless the
financial asset is credit-impaired, in which case interest income is calculated based on amortized
cost of the financial asset.
The Group recognizes an impairment gain or loss in profit or loss for all financial instruments by
adjusting their carrying amount, with the exception of other receivables where the corresponding
adjustment is recognized through a loss allowance account.
Derecognition of financial assets
The Group derecognizes a financial asset only when the contractual rights to the cash flows from the asset
expire, or when it transfers the financial asset and substantially all the risks and rewards of ownership of
the asset to another entity.
On derecognition of a financial asset measured at amortized cost, the difference between the asset’s
carrying amount and the sum of the consideration received and receivable is recognized in profit or loss.
Financial liabilities and equity
Classification as debt or equity
Debt and equity instruments are classified as either financial liabilities or as equity in accordance with
the substance of the contractual arrangements and the definitions of a financial liability and an equity
instrument.
Equity instruments
An equity instrument is any contract that evidences a residual interest in the assets of an entity after
deducting all of its liabilities. Equity instruments issued by the Group are recognized at the proceeds
received, net of direct issue costs.
Financial liabilities
All financial liabilities are subsequently measured at amortized cost using the effective interest method
or at FVTPL.
Financial liabilities at amortized cost
Financial liabilities including bank borrowings, trade and other payables, lease liabilities and amount
due to the Controlling Shareholder are subsequently measured at amortized cost using the effective
interest method.
Redemption liabilities
A contract that contains an obligation to purchase the Group’s equity instruments for cash gives rise to a
financial liability for the present value of the redemption amount, even if the Group’s obligation to
purchase is conditional on the counterparty exercising a right to redeem. The redemption liabilities are
initially recognized as financial liabilities at the present value of the redemption amount, with the
corresponding amount charged against capital reserves within equity. Subsequently, the redemption
liabilities are measured at amortized cost with interest charged in finance costs. If the Group’s obligation
to purchase is terminated, the carrying amount of the financial liability is reclassified to equity.
Derivative financial instruments
Derivatives are initially recognized at fair value at the date when derivative contracts are entered into
and are subsequently remeasured to their fair value at the end of the reporting period. The resulting gain
or loss is recognized in profit or loss.
Derecognition/modification of financial liabilities
The Group derecognizes financial liabilities when, and only when, the Group’s obligations are
discharged, cancelled or have expired. The difference between the carrying amount of the financial
liability derecognized and the consideration paid and payable is recognized in profit or loss.
APPENDIX I ACCOUNTANTS’ REPORT
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When the contractual terms of a financial liability are modified, the Group assess whether the revised
terms result in a substantial modification from original terms taking into account all relevant facts and
circumstances including qualitative factors. If qualitative assessment is not conclusive, the Group
considers that the terms are substantially different if the discounted present value of the cash flows under
the new terms, including any fees paid net of any fees received, and discounted using the original
effective interest rate, is at least 10 per cent different from the discounted present value of the remaining
cash flows of the original financial liability. Accordingly, such modification of terms is accounted for as
an extinguishment, any costs or fees incurred are recognized as part of the gain or loss on the
extinguishment. The exchange or modification is considered as non-substantial modification when such
difference is less than 10 per cent.
For non-substantial modifications of financial liabilities that do not result in derecognition, the carrying
amount of the relevant financial liabilities will be calculated at the present value of the modified
contractual cash flows discounted at the financial liabilities’ original effective interest rate.
Transaction costs or fees incurred are adjusted to the carrying amount of the modified financial liabilities
and are amortized over the remaining term. Any adjustment to the carrying amount of the financial
liability is recognized in profit or loss at the date of modification.
5. CRITICAL ACCOUNTING JUDGEMENT
In the application of the Group’s accounting policies, the directors of the Company are required to make
judgements, estimates and assumptions about the carrying amounts of assets and liabilities that are not
readily apparent from other sources. The estimates and underlying assumptions are based on historical
experience and other factors that are considered to be relevant. Actual results may differ from these
estimates.
The estimates and underlying assumptions are reviewed on an on-going basis. Revisions to accounting
estimates are recognized in the period in which the estimate is revised if the revision affects only that
period, or in the period of the revision and future periods if the revision affects both current and future
periods.
Critical judgement in applying accounting policies
The following is the critical judgement that the directors of the Company have made in the process of
applying the Group’s accounting policies and that has the most significant effect on the amounts
recognized in the Historical Financial Information.
Research and development expenditures
Development expenses incurred on the Group’s product pipelines are capitalized and deferred only
when the Group can demonstrate the technical feasibility of completing the intangible assets so that it
will be available for use or sale, its intention to complete and its ability to use or sell the asset, how the
asset will generate future economic benefits, the availability of resources to complete the pipeline and the
ability to measure reliably the expenditure during the development. Development expenses which do not
meet these criteria are expensed when incurred. The management of the Group assesses the progress of
each of the research and development projects and determines that the Group’s product pipelines do not
meet the above said capitalization criteria. During the Track Record Period, all the development costs are
expensed when incurred.
6. OTHER INCOME
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Interest income on bank deposits ..................... 3,235 2,008
Government grants (Note) .......................... 7 6 7 2 9 3
4,002 2,301
Note: The government grants mainly comprise industry-related subsidies and incentives received upon
fulfilling the conditions for compensation of research and development expenses and other costs
or losses already incurred, or as immediate financial support with no future related costs and not
related to any assets.
7. OTHER GAINS AND LOSSES, NET
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Gain on non-substantial modification of redemption liabilities . . . – 42,081
Gain on early termination of a lease ................... 4 1 4 –
Gain on fair value changes from financial assets at FVTPL ..... 2,028 865
Net foreign exchange gains ......................... 2 2 8 4 8 0
Others ...................................... – (158)
2,670 43,268
APPENDIX I ACCOUNTANTS’ REPORT
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--- page 331 ---
8. FINANCE COSTS
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Interest expense on:
– bank borrowings ............................. 6 6 9 9 8 5
– lease liabilities .............................. 2 0 2 6 6
– redemption liabilities ........................... 36,775 65,952
37,646 67,003
9. LOSS BEFORE TAX
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Loss before tax for the year has been arrived at after charging:
Auditor’s remuneration ........................... 3 0 3 0
Depreciation of plant and equipment ................... 4,853 3,463
Depreciation of right-of-use assets ..................... 3,535 3,111
T otal depreciation .............................. 8,388 6,574
Staff costs
Directors’ and chief executive’s remuneration (Note 11) ....... 3,390 3,344
Other staff costs
– salaries and other benefit ........................ 33,370 43,743
– retirement benefits ............................ 2,575 3,334
T otal staff costs ................................ 39,335 50,421
10. INCOME TAX EXPENSE
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
PRC Enterprise Income Tax (“ EIT” )....................
– current tax ................................. 2 6 –
– over provision in prior years ...................... ( 2 ) –
Deferred tax (Note 26) ............................ – –
24 –
Under the Law of the PRC on Enterprise Income Tax (the “ EIT Law”) and Implementation Regulation of
the EIT Law, the tax rate of the group entities established in the PRC (other than those as described
below) is 25% during the Track Record Period.
Certain subsidiaries of the Company qualified as a Small and Micro Enterprise, and relevant taxable
income was calculated at a reduced base of 25% and EIT was levied at the preferential rate of 20% during
the Track Record Period.
The Group had no estimated assessable profit that was subject to Hong Kong Profits Tax during Track
Record Period.
APPENDIX I ACCOUNTANTS’ REPORT
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--- page 332 ---
The taxation expense for the Track Record Period can be reconciled to the loss before tax per the
consolidated statements of profit or loss and other comprehensive income as follows:
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Loss before tax ................................. (156,808) (184,914)
Tax credit at the applicable income tax rate of 25% .......... (39,202) (46,229)
Over provision in prior years ........................ ( 2 ) –
Tax effect of expenses not deductible for tax purposes ........ 7,199 16,574
Tax effect of income not taxable for tax purposes ............ – (10,520)
Tax effect of super deduction on research and
development expenses ........................... (17,285) (13,556)
Income tax at concessionary rate ...................... (32) –
Tax effect of tax losses not recognized ................... 49,346 53,731
Income tax expense .............................. 24 –
11. DIRECTORS’, CHIEF EXECUTIVE’S’ AND EMPLOYEES’ EMOLUMENTS
Directors’ and Chief Executive’s emoluments
Details of the emoluments paid to the individuals who were appointed as the executive and
non-executive directors of the Company for the service provided to the Group during the Track Record
Period are as follows:
Salaries,
allowance
and
benefits
in kind
Performance-
related
bonuses
Retirement
benefits T otal
RMB’000 RMB’000 RMB’000 RMB’000
For the year ended December 31, 2024
Executive directors:
Dr. Wang Bing (Note i) .............. 1,600 442 38 2,080
Dr. Yu Weiping ................... 1,208 102 – 1,310
Non-executive directors:
D r . W a n g M e i ................... – – – –
Mr. Wang Yiqiang ................. – – – –
Mr. Ju Hangsheng ................. – – – –
Dr. Song Gaoguang ................ – – – –
Mr. Lin Xianghong ................ – – – –
2,808 544 38 3,390
APPENDIX I ACCOUNTANTS’ REPORT
– I-21 –


--- page 333 ---
Salaries,
allowance
and
benefits
in kind
Performance-
related
bonuses
Retirement
benefits T otal
RMB’000 RMB’000 RMB’000 RMB’000
For the year ended December 31, 2025
Executive directors:
Dr. Wang Bing (Note i) .............. 1,605 401 38 2,044
Dr. Yu Weiping ................... 1,200 100 – 1,300
Non-executive directors:
D r . W a n g M e i ................... – – – –
Mr. Wang Yiqiang (Note ii) ............ – – – –
Mr. Ju Hangsheng (Note ii) ........... – – – –
Dr. Song Gaoguang ................ – – – –
Mr. Lin Xianghong (Note ii) ........... – – – –
Mr. You Xiangdong (Note iii) .......... – – – –
Dr. Wang Nayi (Note iii) ............. – – – –
2,805 501 38 3,344
Notes:
i Dr. Wang Bing is an executive director and the Chief Executive Officer of the Company
throughout the Track Record Period. His emoluments disclosed above include those for services
rendered by him as the Chief Executive Officer of the Company.
The emoluments of executive directors shown above were mainly for their services in connection
with the management of the affairs of the Company and the Group. The performance related
bonuses were determined by the management of the Group by reference to the performance.
ii. Mr. Wang Yiqiang, Mr. Lin Xianghong and Mr. Ju Hangsheng resigned as non-executive directors
of the Company on 28 August 2025.
iii. Mr. You Xiangdong and Dr. Wang Nayi were appointed as non-executive directors of the
Company on 28 August 2025.
Dr. Wang Mei did not receive any emoluments from the Group during the Track Record Period. Mr. Wang
Yiqiang, Mr. Ju Hangsheng, Dr. Song Gaoguang, Mr. Lin Xianghong, Mr. Youxiangdong and Dr. Wang
Nayi did not receive emoluments during the Track Record Period, and they also held positions in the
corporate shareholders of the Company (“ Shareholder’s Entities ”), and their emoluments were borne by
the respective Shareholder’s Entities for the services rendered to those entities. In the opinion of the
directors of the Company, it is not practicable to allocate their remuneration to the Group.
There was no arrangement under which a director waived or agreed to waive any emoluments during the
Track Record Period.
12. FIVE HIGHEST PAID EMPLOYEES
Five individuals with the highest emoluments
The five highest paid employees of the Group during the Track Record Period included two and two
directors, details of whose remuneration are set out in Note 11 above. Details of the remuneration for the
year of the remaining three and three highest paid employees who are not directors of the Company are
as follows:
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Salaries, wages and allowance ....................... 3,532 4,792
Performance related bonuses ........................ 2 7 3 8 7 8
Retirement benefits .............................. 1 9 0 1 8 8
3,995 5,858
APPENDIX I ACCOUNTANTS’ REPORT
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--- page 334 ---
The number of the highest paid employees who are not the directors whose remuneration fell within the
following bands is as follows:
For the year ended
December 31,
2024 2025
Number of
employees
Number of
employees
HK$1,000,001 to HK$1,500,000 ....................... 2 1
HK$1,500,001 to HK$2,000,000 ....................... 1 1
HK$2,000,001 to HK$2,500,000 ....................... – 1
33
No emoluments were paid by the Group to the directors or the five highest paid individuals (including
directors and employees), as an inducement to join or upon joining the Group or as compensation for loss
of office during the Track Record Period.
13. DIVIDENDS
No dividend was declared or paid by the Company and its subsidiaries during the Track Record Period,
nor has any dividend been proposed since the end of the Track Record Period.
14. LOSS PER SHARE
The calculation of the basic and diluted loss per share attributable to owners of the Company is based on
the following analysis:
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Loss for the year attributable to owners of the Company for the
purpose of basic and diluted loss per share .............. (154,632) (182,507)
’000 ’000
Number of shares
Weighted average number of ordinary shares for the purpose of
basic and diluted loss per share ..................... 234,250 242,950
The Company was converted from a limited liability company to a joint stock company with limited
liability on December 5, 2024, 4,985,000 ordinary shares with par value of RMB1 each were issued and
allotted to the respective shareholders of the Company according to the paid-in capital registered under
these shareholders on that day. For the purpose of calculating basic loss per share, the number of shares
in issue was deemed to be the weighted average number of ordinary shares, excluding the 300,000 shares
held for share incentive scheme as disclosed in Note 28, as if the Company’s conversion into a joint stock
limited liability company and share subdivision as disclosed in Note 37 had occurred on January 1, 2024.
For the purpose of calculation of diluted loss per share for the years ended December 31, 2024 and 2025,
the potential ordinary shares and the effect of the redemption liabilities were not included as their
inclusion would result in a decrease in loss per share.
APPENDIX I ACCOUNTANTS’ REPORT
– I-23 –


--- page 335 ---
15. PLANT AND EQUIPMENT
The Group
Machinery
and
equipment
Motor
vehicles
Computer
equipment
and software
Office
equipment
Leasehold
improvement
Construction
in progress T otal
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Cost
At January 1, 2024 ...... 20,796 1,337 2,557 735 5,227 154 30,806
Additions .......... 5 6 8 – 6 2 4 7 – 1 0 3 1,302
Transfer ........... 2 57–––– (257) –
Exchange adjustments .... 12–1––– 1 3
At December 31, 2024 .... 21,633 1,337 3,182 742 5,227 – 32,121
Additions .......... 6 4 0 – 2 326–– 8 78
Exchange adjustments .... (21) – (1) – – – (22)
At December 31, 2025 .... 22,252 1,337 3,413 748 5,227 – 32,977
Depreciation
At January 1, 2024 ...... 10,035 1,268 2,021 465 4,257 – 18,046
Provided for the year .... 3,558 – 544 119 632 – 4,853
Exchange adjustments .... 6–––––6
At December 31, 2024 .... 13,599 1,268 2,565 584 4,889 – 22,905
Provided for the year .... 2,746 – 412 85 220 – 3,463
Exchange adjustments .... (12) – (1) – – – (13)
At December 31, 2025 .... 16,333 1,268 2,976 669 5,109 – 26,355
Carrying values
At December 31, 2024 .... 8,034 69 617 158 338 – 9,216
At December 31, 2025 .... 5,919 69 437 79 118 – 6,622
The Company
Machinery and
equipment Motor vehicles
Computer
equipment and
software
Office
equipment
Leasehold
improvement T otal
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Cost
At January 1, 2024 ...... 9,488 1,337 2,038 505 5,227 18,595
Additions .......... 5 4 3 – 6 2 4 7 – 1,174
At December 31, 2024 ..... 10,031 1,337 2,662 512 5,227 19,769
Additions .......... 5 8 8 – 2 3 2 6 – 8 2 6
At December 31, 2025 ..... 10,619 1,337 2,894 518 5,227 20,595
Depreciation
At January 1, 2024 ...... 6,296 1,268 1,691 356 4,257 13,868
Provided for the year ..... 1,538 – 434 76 632 2,680
At December 31, 2024 ..... 7,834 1,268 2,125 432 4,889 16,548
Provided for the year . . . . . 672 – 378 41 220 1,311
At December 31, 2025 ..... 8,506 1,268 2,503 473 5,109 17,859
Carrying values
At December 31, 2024 ..... 2,197 69 537 80 338 3,221
At December 31, 2025 ..... 2,113 69 391 45 118 2,736
APPENDIX I ACCOUNTANTS’ REPORT
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--- page 336 ---
The above items of plant and equipment, after taking into account the residual values, are depreciated on
a straight-line basis over their estimated useful lives at the following:
Machinery and equipment ......................... 5 years
Motor vehicles ................................. 4 years
Computer equipment and software .................... 3 years
Office equipment ............................... 5 years
Leasehold improvement ........................... 5 years or the shorter of
the relevant lease terms
16. RIGHT-OF-USE ASSETS
The Group
Leasehold
land
Leased
properties T otal
RMB’000 RMB’000 RMB’000
Carrying amount
As at December 31, 2024 ................... – 2,842 2,842
As at December 31, 2025 ................... 15,915 2,860 18,775
Depreciation charge
For the year ended December 31, 2024 .......... – 3,535 3,535
For the year ended December 31, 2025 .......... 1 6 1 2,950 3,111
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Expense relating to short-term leases ................... 1 8 1 2 7
Total cash outflow for leases ......................... (3,202) (20,075)
The Company
Leased
properties
RMB’000
Carrying amount
As at December 31, 2024 ....................................... 1,295
As at December 31, 2025 ....................................... 2,405
Depreciation charge
For the year ended December 31, 2024 .............................. 2,036
For the year ended December 31, 2025 .............................. 1,858
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Expense relating to short-term leases ................... 1 4 9 2 7
Total cash outflow for leases ......................... (2,324) (2,871)
For the Track Record Period, the Group and the Company lease properties for its operations and research
activities. Lease contracts are entered into for fixed term of 1 year to 3 years. Lease terms are negotiated
on an individual basis and contain different terms and conditions. In determining the lease term and
assessing the length of the non-cancellable period, the Group and the Company apply the definition of a
contract and determines the period for which the contract is enforceable.
APPENDIX I ACCOUNTANTS’ REPORT
– I-25 –


--- page 337 ---
The Group and the Company regularly entered into short-term leases for machinery and equipment. As
at December 31, 2024 and 2025, the portfolio of short-term leases is similar to the portfolio of short-term
leases to which the short-term lease expense disclosed above.
17. INVESTMENTS IN SUBSIDIARIES
The Company
As at December 31,
2024 2025
RMB’000 RMB’000
Cost of investments .............................. 256,778 311,478
18. CASH AND CASH EQUIV ALENTS/TERM DEPOSITS/RESTRICTED BANK DEPOSITS
The Group
Cash and cash equivalents include demand deposits and short-term deposits (with original maturity of
three months or less) for the purpose of meeting the Group’s short term cash commitments.
As at December 31, 2024 and 2025, cash and cash equivalents carry interest at market rates ranging from
0.05% to 0.65% and 0.01% to 0.65% per annum, respectively. The term deposits are within a term from 1
year to 3 years and carry interest rates ranging from 1.80% to 2.40% and 1.20% to 2.40% per annum,
respectively. The restricted bank deposits are within a term from 1 year to 8 years and carry interest at
rates ranging from 0.70% to 1.1% per annum as at 31 December 2025.
The Company
Cash and cash equivalents include demand deposits and short-term deposits (with original maturity of
three months or less) for the purpose of meeting the Company’s short term cash commitments.
As at December 31, 2024 and 2025, cash and cash equivalents carry interest at market rates ranging from
0.05% to 0.65% and 0.05% to 0.65% per annum, respectively. The term deposits are within a term from 1
year to 3 years and carry interest rates ranging from 1.80% to 2.40% and 1.20% to 2.40% per annum,
respectively. The restricted bank deposits are within a term of 1 year and carry interest rates ranging from
0.7% to 0.8% per annum as at 31 December 2025.
Details of the impairment assessment are set out in Note 32.
19. PREPA YMENTS AND OTHER RECEIV ABLES
The Group
As at December 31,
2024 2025
RMB’000 RMB’000
Deferred issue costs .............................. – 2,435
Prepaid listing expenses ........................... – 8
Other receivables ................................ 2 0 4 3 7 4
Rental deposits for right-of-use assets ................... 2 8 1 2 8 1
Prepayments for research and development services ......... 4,900 9,150
Value added tax (“VAT ”) recoverable ................... 18,723 22,604
Other prepayments .............................. 3 2 8 6 1 7
24,436 35,469
Less: Amounts recoverable within one year shown under
current assets ............................. (5,513) (24,186)
Amounts shown under non-current assets ................ 18,923 11,283
APPENDIX I ACCOUNTANTS’ REPORT
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The Company
As at December 31,
2024 2025
RMB’000 RMB’000
Deferred issue costs .............................. – 2,435
Prepaid listing expenses ........................... – 8
Other receivables ................................ 1 2 2 2 8 4
Rental deposits for right-of-use assets ................... 8 1 8 1
Prepayments for research and development services ......... 2,524 8,898
VAT recoverable ................................ 13,647 16,725
Others ...................................... 2 5 4 5 8 2
16,628 29,013
Less: Amounts recoverable within one year shown under
current assets ............................. (2,981) (23,609)
Amounts shown under non-current assets ................ 13,647 5,404
20. FINANCIAL ASSETS AT FVTPL
The Group
As at December 31,
2024 2025
RMB’000 RMB’000
Structured bank deposits (Note) ...................... 54,611 95,209
The Company
As at December 31,
2024 2025
RMB’000 RMB’000
Structured bank deposits (Note) ...................... 20,056 95,209
Note: The balance of structured bank deposits has a flexible maturity period of no more than six
months. The yield rate stipulated in the contract is floating and linked to the performance of the
underlying assets, such as gold market price and certain exchange rates.
APPENDIX I ACCOUNTANTS’ REPORT
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21. TRADE AND OTHER PA YABLES
The Group
As at December 31,
2024 2025
RMB’000 RMB’000
Trade payables and accruals for research
and development expenses ........................ 33,371 53,690
Payroll payable ................................ 6,491 8,818
Other tax payables .............................. 4 0 8 6 7 6
Government grant collected on behalf of employees ......... 3,157 3,053
Accrued listing expenses .......................... – 4,226
Accrued issue costs .............................. – 1,105
Cash received under the Share Incentive Scheme (Note) ....... – 7,268
Others ...................................... 2,153 3,791
45,580 82,627
Note: The balance represents the cash received for the subscription price of the restricted share units
granted under the Share Incentive Scheme (as defined in Note 28) to certain employees and key
management personnel. Since the restricted share units granted haven’t yet vested, the
subscription price received may be returned to the grantees if they cease employment prior to the
satisfaction of the vesting conditions, in which case the Company has the right to repurchase the
relevant restricted share units.
The average credit term of trade payables is generally ranged between 15 to 90 days.
The following is an aging analysis of trade payables presented based on the invoice date and accruals
which have not yet been billed at the end of each reporting period:
As at December 31,
2024 2025
RMB’000 RMB’000
1-90 days .................................... 1,158 630
91-365 days ................................... 1,575 319
1-2 years ..................................... 4,351 20
2-3 years ..................................... 4 4 0 1,925
Over 3 years .................................. 2 0 7 6 4 4
7,731 3,538
Not yet billed .................................. 25,640 50,152
33,371 53,690
The Company
As at December 31,
2024 2025
RMB’000 RMB’000
Trade payables and accruals for research and
development expenses ........................... 25,664 46,132
Payroll payable ................................ 4,422 6,280
Other tax payables .............................. 2 0 5 5 3 4
Accrued listing expenses .......................... – 4,226
Accrued issue costs .............................. – 1,105
Others ...................................... 7 0 8 2,940
30,999 61,217
The normal credit term of trade payables is generally ranged between 15 to 90 days.
APPENDIX I ACCOUNTANTS’ REPORT
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The following is an aging analysis of trade payables presented based on the invoice date and accruals
which have not yet been billed at the end of each reporting period:
As at December 31,
2024 2025
RMB’000 RMB’000
1-90 days .................................... 4 1 8 5 3 5
91-365 days ................................... 1,575 102
1-2 years ..................................... 4 6 7 2 0
2-3 years ..................................... 4 4 0 1
Over 3 years .................................. 4 4 4 8 0
2,944 1,138
Not yet billed .................................. 22,720 44,994
25,664 46,132
22. BANK BORROWINGS
The Group and the Company
As at December 31,
2024 2025
RMB’000 RMB’000
Bank borrowings
– Unsecured and unguaranteed ..................... 44,013 48,100
The carrying amount of the above borrowings are analyzed based on contractual repayment date as
follows:
As at December 31,
2024 2025
RMB’000 RMB’000
The carrying amounts of the borrowing are repayable:
Within one year ............................... 1,760 48,100
Within a period of more than one year but not
exceeding two years ........................... 42,253 –
44,013 48,100
Less: Amounts due within one year shown under
current liabilities .......................... (1,760) (48,100)
Amounts shown under non-current liabilities ............. 42,253 –
The ranges of effective interest rate of the Group and the Company’s bank borrowings are as follows:
As at December 31,
2024 2025
Effective interest rate per annum:
– Variable-rate borrowings ........................ 2.30%-2.50% 1.85%-1.95%
The Group’s and the Company’s variable-rate borrowings carry interest at 115 basis points below the
one-year loan prime rate in the PRC. Interest rate is reset every twelve months.
In respect of bank borrowings with carrying amount of RMB44,013,000 and RMB48,100,000 as at
December 31, 2024, and 2025, respectively, the Company may be required to make immediate repayment
of bank borrowings if any of the following events occurs during the borrowing term:
• A change in the ownership structure or the controlling shareholder;
• A transfer of ownership of the pipeline(s);
• Fails to complete an initial public offering by December 31, 2025 and trigger share redemption
obligation under the relevant agreements as at December 31, 2024. An extension was
subsequently obtained in 2025, extending the initial public offering deadline to June 30, 2026.
The Company has complied with the relevant covenants on or before the end of each reporting period.
APPENDIX I ACCOUNTANTS’ REPORT
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23. AMOUNT(S) DUE FROM (TO) THE CONTROLLING SHAREHOLDER/(A) SUBSIDIARY/
SUBSIDIARIES/A RELATED PARTY
(a) Amount due to the Controlling Shareholder
The Group and the Company
As at December 31,
2024 2025
RMB’000 RMB’000
Dr. Wang Bing ............................ 28,333 –
Note: The balance as at January 1, 2024 is RMB28,333,000. On August 22, 2023, the Company
entered into an agreement with Dr. Wang Bing, the Controlling Shareholder of the
Company, to acquire his equity interest in Xi’an Biocare for a total consideration of
RMB58,300,000. The outstanding amount of RMB28,333,000 as at December 31, 2024 has
been paid in cash during the year ended December 31, 2025.
The balances as at December 31, 2024 is non-trade related, unsecured, unguaranteed, repayable
on demand and non-interest bearing.
(b) Amount due to a subsidiary
The Company
As at December 31,
2024 2025
RMB’000 RMB’000
ʮ̡
(Micot (Suzhou) Pharmaceutical Co., Ltd*)
(“Suzhou Pharmaceutical ” ) .................. – 26,500
Note: The balance as at January 1, 2024 is nil. The balance as at December 31, 2025 is non-trade
related, unsecured, unguaranteed, repayable on demand and non-interest bearing.
* English name for identification purpose only
(c) Amounts due from subsidiaries
The Company
As at December 31,
2024 2025
RMB’000 RMB’000
T rade in nature (Note a)
ʮ̡
(Shanghai Xitaili Biomedical Technology Co., Ltd.*)
(“Shanghai Xitaili ” ) ....................... 12,303 18,103
Xi’an Biocare ............................. 8,598 9,732
20,901 27,835
Non-trade in nature (Note b)
ʮ̡(Micot (Suzhou) Technology
Co., Ltd.*) (“Suzhou T echnology ” ) .............. – 3,000
Xi’an Biocare ............................. 2,855 2,855
2,855 5,855
23,756 33,690
Notes:
(a) The total balance as at January 1, 2024 is amounted to RMB30,945,000. The balances as at
December 31, 2024, and 2025 are trade related, unsecured, interest free and the credit
period granted is 30 days.
APPENDIX I ACCOUNTANTS’ REPORT
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(b) The total balance as at January 1, 2024 is amounted to RMB2,855,000. The balance as at
December 31, 2024, and 2025 are non-trade related, unsecured, interest free and
repayment on demand.
Its maximum amounts outstanding during the years ended December 31, 2024 and 2025
are RMB2,855,000 and RMB5,855,000, respectively.
* English name for identification purpose only
The following is an aging analysis of trade related amounts due from subsidiaries presented
based on the dates of services delivery at the end of each reporting period:
As at December 31,
2024 2025
RMB’000 RMB’000
1-30 days ................................ 9 7 4 3,869
30-365 days .............................. 3,551 3,065
1-2 years ................................ 16,376 4,525
2-3 years ................................ – 16,376
20,901 27,835
(d) Amount due from a related party
The Group
As at December 31,
2024 2025
RMB’000 RMB’000
ʮ̡
(Xi’an Zhongrui Zekang Enterprise Management
Consulting Co., Ltd.*) (“ Zhongrui Zekang” ) ........ 6 5 2 1,087
Note: The balance as at January 1, 2024 is RMB701,000. Zhongrui Zekang is the general partner
of the Employee Incentive Platform (as defined in Note 28), collecting the employees’
payments of exercise or subscription prices for the share options/shares under the share
incentive scheme on behalf of the Company. The balances as at December 31, 2024 and
2025 are non-trade related, unsecured, interest free and repayment on demand.
Its maximum amounts outstanding during the years ended December 31, 2024 and 2025
are RMB709,000 and RMB1,087,000, respectively.
The amount due from Zhongrui Zekang had been settled as of the date of this prospectus.
24. LEASE LIABILITIES
The Group
As at December 31,
2024 2025
RMB’000 RMB’000
Within one year ................................ 2,259 1,399
Within a period of more than one year but not more than
two years ................................... 2 8 0 2 0 2
2,539 1,601
Less: Amount due for settlement within one year
shown under current liabilities .................. (2,259) (1,399)
Amount shown under non-current liabilities .............. 2 8 0 2 0 2
The weighted average incremental borrowing rates applied to the Group’s lease liabilities range from
2.50% to 4.65% per annum as at December 31, 2024, and 3.50% to 4.45% per annum as at December 31,
2025.
APPENDIX I ACCOUNTANTS’ REPORT
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The Company
As at December 31,
2024 2025
RMB’000 RMB’000
Within one year ................................ 1,165 1,119
Within a period of more than one year but not more than
two years ................................... – 2 0 2
1,165 1,321
Less: Amount due for settlement within one year
shown under current liabilities .................. (1,165) (1,119)
Amount shown under non-current liabilities .............. – 2 0 2
The weighted average incremental borrowing rates applied to lease liabilities range from 2.50% to 4.45%
per annum as at December 31, 2024 and 3.50% to 4.45% per annum as at December 31, 2025.
25. REDEMPTION LIABILITIES
The Group and the Company
Since the date of incorporation, the Company has completed several rounds of financing by issuing
shares with preferential rights to investors (the “ Investors”). Details of shares with preferential rights are
set out below.
Date of agreement
Subscription
price per share
Number of
ordinary shares
issued
T otal
consideration
RMB or
equivalent to
RMB
Series A .... July 30, 2019 RMB166.6667/
United States Dollar
(“USD”) 23.5833
690,000 115,000,000
Series B .... February 21, 2021 RMB365.8537/USD56.1582 984,000 360,000,000
Series B1 . . . August 30, 2021 RMB470.6889 138,095 65,000,000
Series C .... January 16, 2023 RMB550.6957 172,509 95,000,000
Series D .... June 27, 2025/
September 19, 2025/
September 24, 2025/
September 26, 2025
RMB481.4819 489,115 235,500,000
2,473,719 870,500,000
The key terms of preferential rights are as follows:
(a) Redemption right
The Investors have the right to require the Company and/or the founder to redeem their
investments for cash upon certain events, including (i) a non-completion of a qualified initial
public offering of the Company by June 30, 2027 (extended from June 30, 2026 after the Company
submitted its listing application to the Stock Exchange in September 2025 and the application is
still under review); or (ii) a change of control of the ultimate controller; or (iii) if the Company,
existing shareholders, or the ultimate controller seriously violate the provision of the transaction
documents; or (iv) if the representations, warranties, and covenants made by the Company, its
existing shareholders, or ultimate controllers to the Investors to be found to contain materially
false, misleading, or omitted information, and such inaccuracies cause a material adverse effect
on the Company; (v) if the ultimate controller or the Company becomes involved in any disputes
due to the infringement of third-party intellectual property rights related to certain research and
development projects, causing significant adverse effects on the Company or leading to
substantial compensation.
In addition to the foregoing events, certain Series D investor has the right to require the Company
and/or the founder to redeem its investment upon certain events including if the Company fails
to obtain the construction permit for the Company’s construction project in Taizhou Bay
Economic and Technological Development Zone within 10 months after acquiring the land use
right in that area. Such event results in the Company’s redemption liabilities to this investor being
classified as current liabilities.
The redemption amount is the original investment principal from the investors, plus a simple
interest of 8% per annum calculated on for Series D investors, or 12% per annum for Series A,
Series B, Series B1 and Series C investors.
APPENDIX I ACCOUNTANTS’ REPORT
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(b) Liquidation preference
In the event of a legal liquidation (refers to the liquidation, dissolution or winding up of the
Company) or a deemed liquidation (refers to the change of control of the Company or the sale of
all or substantially all properties of the Company), after paying the liquidation expenses,
employee salaries, social insurance, statutory severance payments, unpaid taxes, and all
creditors’ claims and claims that may be preferred by applicable law, the higher of (1) the original
investment principal, plus a simple interest of 8% per annum calculated on for Series D investors,
or 12% per annum for Series A, Series B, Series B1 and Series C investors, (2) the distributable
liquidation property can be distributed according to the equity proportion at that time, and in the
priority order of Series D, Series C, Series B1, Series B to Series A.
No dividend was paid to the Investors during the Track Record Period.
(c) Anti-dilution right
If the Company issues new shares at a price lower than the price paid by the Investors, the
Investors shall have the right to require: (1) the Company to issue new shares at a nominal price of
RMB1 or the lowest consideration permitted by law, (2) the founder to transfer shares at the
lowest consideration permitted by law, or (3) the Company to settle the difference in cash to
investors, so that the equity portion held by the Investors can reach that can be subscribed
according to the adjusted subscription price per unit.
All preferential rights shall be terminated on the date immediately before the date of the submission of
the listing application to the Hong Kong Stock Exchange and be reinstated and restored in the event of
rejection, return and/or termination of the listing application. Provided the redemption rights shall be
reinstated upon the occurrence of certain agreed uncontrollable events, all redemption liabilities were
still being recognized.
T ermination and regrant of preferential rights
The Company and the Series A, B, B1 and C investors entered into a preferential rights termination
agreement on April 29, 2024, pursuant to which the Company’s obligation for the redemption rights,
anti-dilution rights and liquidation preference rights held by these investors shall be terminated since
April 30, 2024 while the founders’ obligation remained effective. On June 27, 2025, the Company and the
Investors entered into shareholding agreements for Series D financing (the “ Series D Shareholding
Agreements”), pursuant to which the preferential rights including the redemption rights, anti-dilution
rights and liquidation preference rights were regranted to investors of Series A, Series B, Series B1 and
Series C, effective June 27, 2025. Consequently, the Company’s corresponding obligation was reinstated
as of that date. Meanwhile, the preferential rights for the Series D investors became effective in July 2025
upon the closing of the Series D financing.The Company has not provided any guarantee in relation to the
preferential rights, and as the Company has no obligations in this regard, no liabilities from any
preferential right have been recorded between April 30, 2024 and June 27, 2025.
Presentation and classification
The redemption rights and liquidation preference rights granted to the Investors constitute as the
Company’s obligations to repurchase its own equity instruments for cash. These obligations were
recognized as redemption liabilities which are initially measured at fair value (representing the present
value of the expected maximum cash flows for settling the related obligations if these rights are exercised
by the Investors) and subsequently measured at amortized cost. The Company applied a redemption
discount rate ranged from 12.37% to 16.12% to determine the initial recognition amount of the
redemption liabilities. The anti-dilution right is accounted for as a derivative financial instrument
measured at FVTPL. Its fair value was considered insignificant.
Pursuant to the preferential rights termination agreement entered into by the Company and the Series A,
B, B1 and C investors on April 29, 2024, the redemption liabilities of RMB782,130,000 were reclassified
and credited against the capital reserve within equity, accordingly.
On June 27, 2025, pursuant to the Series D Shareholding Agreements, the preferential rights including the
redemption rights, liquidation preference rights and anti-dilution rights were regranted to investors of
Series A, Series B, Series B1 and Series C. The redemption liabilities were recognized at fair value on the
date of modification from equity instruments, with the corresponding amount charged against capital
reserve within equity. The redemption liabilities are subsequently measured at amortized cost.
APPENDIX I ACCOUNTANTS’ REPORT
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The movement of the redemption liabilities is set out as below:
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
At January 1 ................................... 745,048 –
Recognition ................................... – 1,137,266
Charge to finance costs ............................ 36,775 65,952
Reclassification to equity ........................... (782,130) –
Modification of redemption liabilities (Note i) ............. – (42,081)
Foreign exchange losses (gains) ...................... 3 0 7 (2,119)
At December 31 ................................ – 1,159,018
Less: Amount due for settlement within one year shown
under current liabilities (Note ii) ................. – (134,281)
Amount shown under non-current liabilities .............. – 1,024,737
Notes:
i According to the Series D shareholders agreement, upon the submission of the listing application
to the Stock Exchange in September 2025, the redemption date has extended from June 30, 2026 to
June 30, 2027. The extension of the redemption date does not constitute a substantial modification
and the Company adjusted the amortized cost of the financial liabilities by discounting the
modified cash flows using the original effective interest rate and recognizes the changes in other
gain and losses at the modification date.
ii. As disclosed in (a) above, due to that the redemption event for certain Series D investor might
occur within 12 months after the year end, the Company’s redemption liabilities to this investor
have been classified as current liabilities.
26. DEFERRED TAX ASSETS/LIABILITIES
For the purpose of presentation in the statements of financial position, certain deferred tax assets and
liabilities have been offset. The following is the analysis of the deferred tax balances for financial
reporting purposes:
The Group
As at December 31,
2024 2025
RMB’000 RMB’000
Deferred tax assets .............................. 7 0 4 7 6 7
Deferred tax liabilities ............................ (704) (767)
––
The followings are the major deferred tax assets (liabilities) and movements thereon during the Track
Record Period:
Right-of-
use assets
Lease
liabilities
Fair value
changes of
financial
assets at
FVTPL
Ta x
losses T otal
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At January 1, 2024 ............ (2,010) 1,860 (99) 249 -
Credit (charge) to profit or loss .... 1,299 (1,224) 85 (160) -
At December 31, 2024 .......... ( 7 1 1 ) 6 3 6 (14) 89 –
(Charge) credit to profit or loss .... ( 5 ) (235) (38) 278 –
At December 31, 2025 .......... (716) 401 (52) 367 –
APPENDIX I ACCOUNTANTS’ REPORT
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At December 31, 2024 and 2025, the Group has unused tax losses of RMB888,803,000 and
RMB1,103,265,000 respectively, available to offset against future profits. At December 31, 2024 and 2025,
unused tax losses of RMB356,000 and RMB1,468,000 had been recognized as deferred tax assets, while
RMB888,447,000 and RMB1,101,797,000 had not been recognized as deferred tax assets due to the
unpredictability of future profit streams. For these unrecognized tax losses, pursuant to the relevant laws
and regulations in the PRC, these tax losses will be carried forward and expired in years as follows:
As at December 31,
2024 2025
RMB’000 RMB’000
2025 ........................................ 4 6 2 –
2026 ........................................ 24,268 23,691
2027 ........................................ 39,623 39,088
2028 ........................................ 60,231 60,231
2029 ........................................ 126,636 126,636
2030 ........................................ 49,849 81,005
2031 ........................................ 143,408 143,408
2032 ........................................ 175,687 175,687
2033 ........................................ 107,698 107,698
2034 ........................................ 151,896 151,896
2035 ........................................ – 183,562
Indefinite .................................... 8,689 8,895
888,447 1,101,797
Note: In accordance with the relevant laws and regulations in the PRC, the Company and its subsidiary,
Xi’an Biocare, as technology-based SMEs, are entitled to a carryforward period of up to ten years
for unrecognized tax losses. Subsidiaries registered in the United States are permitted an
indefinite carryforward period for unrecognized tax losses, in accordance with applicable local
laws and regulations. For all other subsidiaries, the carryforward period for unrecognized tax
losses is five years.
The Company
Right-of-
use assets
Lease
liabilities
Fair value
changes of
financial
assets at
FVTPL T ax losses T otal
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At January 1, 2024 ............ (761) 743 (98) 116 –
Credit (charge) to profit or loss .... 4 3 7 (452) 84 (69) –
At December 31, 2024 .......... (324) 291 (14) 47 –
(Charge)credit to profit or loss .... (278) 39 (38) 277 –
At December 31, 2025 .......... (602) 330 (52) 324 –
At December 31, 2024 and 2025, the Company has unused tax losses of RMB608,763,000 and
RMB790,488,000 respectively, available to offset against future profits. At December 31, 2024 and 2025,
unused tax losses of RMB188,000 and RMB1,296,000 had been recognized as deferred tax assets, while
RMB608,575,000 and RMB789,192,000 had not been recognized as deferred tax assets due to the
unpredictability of future profit streams. For these unrecognized tax losses, pursuant to the relevant laws
and regulations in the PRC, these tax losses will be carried forward and expired in years as follows:
APPENDIX I ACCOUNTANTS’ REPORT
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The unrecognized tax losses will be carried forward and expire in years as follows:
As at December 31,
2024 2025
RMB’000 RMB’000
2026 ........................................ 5 7 3 –
2027 ........................................ 4,826 4,291
2028 ........................................ 2,485 2,485
2029 ........................................ 52,291 52,291
2030 ........................................ 43,086 43,086
2031 ........................................ 131,175 131,175
2032 ........................................ 138,759 138,759
2033 ........................................ 88,119 88,119
2034 ........................................ 147,261 147,261
2035 ........................................ – 181,725
608,575 789,192
27. RETIREMENT BENEFIT PLANS
The employees of the Group are members of the state-managed retirement benefits schemes operated by
government. The Group is required to contribute a certain percentage of payroll costs to the retirement
benefits schemes to fund the benefits. The only obligation of the Group with respect to the retirement
benefits schemes is to make the specified contributions.
The total expense recognized in profit or loss of RMB2,613,000 and RMB3,372,000 for the years ended
December 31, 2024 and 2025, respectively.
28. SHARE-BASED PA YMENT TRANSACTIONS
The Group and the Company
Share Incentive Scheme
The Company’s employee share incentive scheme (the “ Share Incentive Scheme ”) was adopted pursuant
to a resolution passed by the board of directors meeting on June 11, 2020 for the primary purpose of
providing incentives to eligible employees and the parties working for the interests of the Group
(collectively the “grantees”). According to the resolution, a limited partnership, Xi’an Zhongrui
Hongyuan Information Technology Partnership (Limited Partnership)* (ҦΥྫΆุ
Υྫ) (the “Employee Incentive Platform ”), was established and 300,000 shares of the registered
capital of the Company were transferred from the founder and founder’s family members to the
platform. The incentives are granted to the eligible grantees in the form of share options or restricted
shares to subscribe the interests of the Employee Incentive Platform.
* English name for identification purpose only
Each of the incentive awards needs to meet service requirement from the grant date to the later of (1) four
or five years since the grant date (the “ Service Period”) and (2) successful IPO of the Company. In the
Service Period, 60% and 20% of the total number of awards shall be released to the eligible grantees on
second anniversary date and each of the third to fourth anniversary dates of the grant date upon meeting
certain individual performance targets or 40% and 20% of the total number of awards shall be released to
eligible grantees on the second anniversary date and each of the third to fifth anniversary dates of the
grant date upon meeting certain individual performance targets. The eligible grantees may be repaid
with original exercise/subscription price plus single digit interest, at the Company’s sole discretion, if
employment were terminated within the Service Period or before the successful listing of the Company.
After taking into account the best estimation of the listing date, the management determined the
share-based payment expenses should be recognized when the successful listing is probable and
amortized during vesting period which is from the grant date to the later of the Service Period and
estimated listing date.
Modification of Share Incentive Scheme
Pursuant to a resolution passed by the shareholders meeting on August 28, 2025, the Share Incentive
Scheme was amended and all the share options and restricted shares granted have been transferred to
restricted share units (the “ RSUs”) with the grantees, quantities, subscription price and vesting term
unchanged. Accordingly, the modification is a replacement of the original incentives. Since the
modification is not beneficial to the grantees and there is no incremental fair value due to the
modification, the Company continued to recognize the services received over the original vesting period.
APPENDIX I ACCOUNTANTS’ REPORT
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Share options/RSUs
The movements of the share options granted to the directors, consultant and employees of the Group and
the Company during the year ended December 31, 2024 are as follows:
Type of
option holders Date of grant
Exercise
price
Outstanding
at January 1,
2024
Granted
during the
year
Forfeited
during the
year
Outstanding
at December
31, 2024
Executive director:
Dr. Yu Weiping .... July 3, 2020 RMB0 89,982 – – 89,982
89,982 – – 89,982
Consultants ...... July 3, 2020 RMB25 14,080 – – 14,080
14,080 – – 14,080
Employees: ....... July 3, 2020 RMB20-25 20,696 – (2,400) 18,296
July 3, 2022 RMB70.6 9,666 – – 9,666
July 3, 2023 RMB82.6 4,721 – (2,270) 2,451
35,083 – (4,670) 30,413
139,145 – (4,670) 134,475
Upon the modification in 2025, the options have been transferred to RSUs with the same quantities. The
movements of the share options/RSUs granted to the directors, consultants and employees of the Group
and the Company during the year ended December 31, 2025 are as follows:
Type of option/
RSU holders Date of grant
Exercise
price/
Subscription
price
Outstanding at
January 1, 2025
Granted during
the period
Forfeited
during the
period
Outstanding at
December 31,
2025
Executive director:
Dr. Yu Weiping ..... July 3, 2020 RMB0 89,982 – – 89,982
89,982 – – 89,982
Consultants ....... July 3, 2020 RMB25 14,080 – – 14,080
September 18, 2025 RMB72.77 – 623 – 623
14,080 623 – 14,703
Employees: ........ July 3, 2020 RMB20-25 18,296 – (2,028) 16,268
July 3, 2022 RMB70.60 9,666 – (1,945) 7,721
July 3, 2023 RMB82.60 2,451 – (228) 2,223
May 13, 2025 RMB82.60 – 12,584 – 12,584
September 18, 2025 RMB72.77 – 62,105 – 62,105
30,413 74,689 (4,201) 100,901
134,475 75,312 (4,201) 205,586
APPENDIX I ACCOUNTANTS’ REPORT
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Share options
The binomial model has been used to estimate the fair value of the options. The variables and
assumptions used in computing the fair value of the share options are based on the Group’s best estimate.
The inputs into the binomial model were as follows:
As at July 3,
As at
May 13,
Grant date 2020 2022 2023 2025
Fair value of underlying ordinary
shares (RMB per share) . . . . . . . . . 241 451 457 441
Exercise price (RMB) ............ 0-25 70.6 82.6 82.6
Risk-free interest rate ........... 2.61% 2.60% 2.33% 1.50%-1.54%
Expected volatility ............. 56.75% 59.59% 62.08% 65.28%-66.58%
Dividend yield ............... – – – –
Exercise multiples ............. 2.2-2.8 2.2 2.2 2.2
Life of options (years) ........... 5 4 4 4 - 5
Fair value of options (RMB per option) 219-241 386 382 366-371
RSUs
For the RSUs granted on September 18, 2025, the grant date fair value was RMB371.74 per share
determined by reference to the fair value of the Company’s ordinary shares priced using the equity
allocation model and the subscription prices.
Restricted shares
In addition to the above, on July 3, 2020, 11,998 restricted shares were granted to two consultants, who
provide services similar to employees, at subscription prices of RMB25 per share and RMB0.0002 per
share. The grant date fair value of restricted shares was RMB216 and RMB241 per share determined by
reference to the fair value of the Company’s ordinary shares priced using the equity allocation model and
the subscription prices.
As at December 31, 2024 and 2025, 300,000 shares held by Employee Incentive Platform under the Share
Incentive Scheme were recognized as treasury shares by the Company and had been deducted from
shareholders’ equity as shown in the consolidated statements of changes in equity under “Shares issued
for share incentive scheme”. The exercise price or subscription price received by the Company amounted
to RMB7,268,000 has been recognized under other payables as the Company may repurchase the granted
shares if they were subsequently forfeited or not vested.
No share-based payment expenses in respect of the share options and restricted shares have been
recognized during the Track Record Period as the successful listing has not been determined to be
probable during the Track Record Period.
29. PAID-IN CAPITAL/SHARE CAPITAL
The Group and the Company
Paid-in
capital
Number of
shares
Share
capital
RMB’000 RMB’000
Issued and fully paid:
At January 1, 2024 ...................... 4,985 – –
Conversion into a joint stock company (Note a) .... (4,985) 4,984,604 4,985
At December 31, 2024 .................... – 4,984,604 4,985
Issuance of Series D shares (Note b) ............ – 489,115 489
At December 31, 2025 .................... – 5,473,719 5,474
Notes:
(a) Pursuant to the shareholders’ resolutions and the promoters’ agreement dated December 5, 2024,
the shareholders of the Company agreed to convert the Company into a joint stock limited
liability company. The net assets of the Company as of the conversion base date, which is April 30,
2024, including paid-in capital, capital reserve, statutory reserve and accumulated losses were
converted into 4,985,000 ordinary shares of RMB1.00 each. The excess of the net assets converted
over the nominal value of the ordinary shares was credited to the Company’s capital reserves. The
Company was converted into a joint-stock limited liability company under PRC Company Law,
and changed its name to Shaanxi Micot Pharmaceutical Technology Co., Ltd. (ٰ
ʮ̡) on December 9, 2024.
APPENDIX I ACCOUNTANTS’ REPORT
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(b) The Company completed Series D financing in 2025. The paid-in capital and share capital at the
end of reporting date include those attributable to Series A to D financing as disclosed in Note 25.
30. RESERVES OF THE COMPANY
Capital
reserve
Statutory
reserve
Accumulated
losses T otal
RMB’000 RMB’000 RMB’000 RMB’000
At January 1, 2024 ................ 131,334 1,500 (436,067) (303,233)
Loss and total comprehensive expense
for the year ................... – – ( 1 18,122) (118,122)
Reclassification from redemption liabilities
(Note 25) ..................... 782,130 – – 782,130
Conversion into a joint stock company .... (267,399) (1,500) 268,899 –
At December 31, 2024 .............. 646,065 – (285,290) 360,775
Loss and total comprehensive expense
for the year ................... – – (151,703) (151,703)
Recognition of redemption liabilities
(Note 25) ..................... (1,137,266) – – (1,137,266)
Capital injection from shareholders ...... 235,011 – – 235,011
At December 31, 2025 .............. (256,190) – (436,993) (693,183)
31. CAPITAL RISK MANAGEMENT
The Group manages its capital to ensure that the entities in the Group will be able to continue as a going
concern while maximising the return to shareholders through the optimisation of the debt and equity
balance. The Group’s overall strategy remains unchanged throughout the Track Record Period.
The capital structure of the Group consists of net debt, which includes bank borrowings, lease liabilities,
redemption liabilities, net of cash and cash equivalents and equity of the Group, comprising issued share
capital, reserves and non-controlling interests.
The management of the Group reviews the capital structure from time to time. As a part of this review, the
management considers the cost of capital and the risks associated with the capital. Based on
recommendations of the management, the Group will balance its overall capital structure through the
issue of new shares and new debts.
32. FINANCIAL INSTRUMENTS
(a) Categories of financial instruments
The Group
As at December 31,
2024 2025
RMB’000 RMB’000
Financial assets
Financial assets measured at FVTPL ............... 54,611 95,209
Financial assets measured at amortized cost .......... 156,638 176,041
211,249 271,250
As at December 31,
2024 2025
RMB’000 RMB’000
Financial liabilities
Financial liabilities measured at amortized cost ....... 85,387 1,222,831
APPENDIX I ACCOUNTANTS’ REPORT
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The Company
As at December 31,
2024 2025
RMB’000 RMB’000
Financial assets
Financial assets measured at FVTPL ............... 20,056 95,209
Financial assets measured at amortized cost .......... 172,495 167,971
192,551 263,180
As at December 31,
2024 2025
RMB’000 RMB’000
Financial liabilities
Financial liabilities measured at amortized cost ....... 75,998 1,243,027
(b) Financial risk management objectives and policies
The Group’s and the Company’s major financial instruments include cash and cash equivalents,
term deposits, restricted bank deposits, financial assets at FVTPL, other receivables, redemption
liabilities, trade and other payables, amount due from a related party, amount due to the
Controlling Shareholder, bank borrowings and amounts due from/to subsidiaries of the
Company. Details of these financial instruments are disclosed in the respective notes. The risks
associated with these financial instruments and the policies on how to mitigate these risks are set
out below. The directors of the Group and the Company manage and monitor these exposures to
ensure appropriate measures are implemented on a timely basis and in an effective manner.
Market risk
The Group’s and the Company’s activities expose it primarily to market risk (currency risk and
interest rate risk), credit risk and liquidity risk. There has been no change in the Group’s and the
Company’s exposure to these risks or the manner in which it manages and measures the risks.
(i) Currency risk
Certain financial assets and liabilities are denominated in foreign currencies of respective
group entities which are exposed to foreign currency risk. The Group currently does not
have a foreign currency hedging policy. However, the management monitors foreign
exchange exposure and will consider hedging significant foreign currency exposure
should the need arise.
The carrying amounts of the Group’s and the Company’s foreign currencies denominated
monetary assets and liabilities at the end of each reporting period are as follows:
The Group
As at December 31,
2024 2025
RMB’000 RMB’000
Assets
U S D............................. 30,439 28,087
Liabilities
U S D............................. – 1 17,539
The Company
As at December 31,
2024 2025
RMB’000 RMB’000
Assets
U S D............................. 30,417 28,081
Liabilities
U S D............................. – 1 17,539
APPENDIX I ACCOUNTANTS’ REPORT
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Sensitivity analysis
The following table details the Group’s and the Company’s sensitivity to a 2% increase
and decrease in RMB against USD, the foreign currencies with which the Group and the
Company may have a material exposure. 2% represents management’s assessment of the
reasonably possible change in foreign exchange rates. The sensitivity analysis uses
outstanding foreign currencies denominated monetary items as a base and adjusts their
translation at the end of each reporting period for a 2% change in foreign currency rates. A
positive/negative number below indicates a decrease/an increase in loss where RMB
strengthens 2% against USD. For a 2% weakening of RMB against USD, there would be an
equal and opposite impact on the profit or loss for the respective years.
The Group
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Profit or loss ......................... 4 5 7 (1,342)
The Company
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Profit or loss ......................... 4 5 6 (1,342)
(ii) Interest rate risk
The Group and the Company are exposed to fair value interest rate risk in relation to term
deposits, redemption liabilities and lease liabilities. The Group and the Company are also
exposed to cash flow interest rate risk in relation to variable-rate bank balances and
variable-rate bank borrowings. The cash flow interest rate risk is mainly concentrated on
the fluctuation of interest rates on bank balances and bank borrowings. As the
management considers that the exposure of cash flow interest rate risk arising from
variable-rate bank balances and variable-rate bank borrowings is insignificant, therefore
no sensitivity analysis on such risk has been prepared.
Credit risk and impairment assessment
Credit risk refers to the risk that the Group’s and the Company’s counterparties default on their
contractual obligations resulting in financial losses to the Group and the Company. The Group’s
and the Company’s credit risk exposures are primarily attributable to other receivables, amounts
due from subsidiaries and bank balances and term deposits. The Group and the Company do not
hold any collateral or other credit enhancements to cover its credit risks associated with its
financial assets.
The Group and the Company performed impairment assessment for financial assets under ECL
model. Information about the Group’s and the Company’s credit risk management, maximum
credit risk exposures and the related impairment assessment, if applicable, are summarized as
below:
Other receivables and amount due from a related party
For other receivables and amount due from a related party, with the aggregate gross carrying
amounts of RMB1,137,000 and RMB1,742,000 for the Group, and RMB203,000 and RMB365,000 for
the Company as at December 31, 2024 and 2025, respectively, the management makes periodic
individual assessment on the recoverability of other receivables based on historical settlement
records, past experience, and also quantitative and qualitative information that is reasonable and
supportive forward-looking information. The management believes that there are no significant
increase in credit risk of these amounts since initial recognition and the Group provided
impairment based on 12m ECL. During the Track Record Period, the Group assessed the ECL on
other receivables and amount due from a related party are insignificant and thus no loss
allowance is recognized.
Amounts due from subsidiaries
For amounts due from subsidiaries with gross carrying amounts of RMB23,756,000 and
RMB33,690,000 for the Company as at December 31, 2024 and 2025, respectively, the ECL on
amounts due from subsidiaries are assessed individually based on the probability of defaults of
amounts due from subsidiaries, the management has taken into account the financial position of
the counterparties as well as forward looking information that is available without undue cost or
effort. During the Track Record Period, the Company assessed the ECL on amounts due from
subsidiaries is insignificant and thus no loss allowance is recognized.
APPENDIX I ACCOUNTANTS’ REPORT
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--- page 353 ---
Bank balance, term deposits and restricted bank deposits
For bank balance, term deposits and restricted bank deposits with the aggregate gross carrying
amounts of RMB155,501,000 and RMB174,299,000 for the Group, and RMB148,536,000 and
RMB133,916,000 for the Company as at December 31, 2024 and 2025, respectively, the credit risk
on bank balances and term deposits is limited because the counterparties are banks with high
credit ratings assigned by international credit-rating agencies. The Group assessed 12m ECL for
bank balances and term deposits by reference to information relating to probability of default and
loss given default of the respective credit rating grades published by external credit rating
agencies. Based on the average loss rates, the 12m ECL on bank balances and term deposits is
considered to be insignificant and therefore no loss allowance was recognized.
Liquidity risk
In the management of the liquidity risk, the Group and the Company closely monitor its cash
position resulting from its operations and maintains a level of cash and cash equivalents deemed
adequate by the management to enable the Group and the Company to meet in full its financial
obligations as they fall due for the foreseeable future. The management of the Group monitors the
utilization of bank borrowings and ensures compliance with loan covenants.
The Group and the Company rely on bank borrowings as a significant source of liquidity. The
Group and the Company had unutilized bank facilities of approximately RMB5,147,000 and
RMB59,200,000 as at December 31, 2024 and 2025, respectively.
The following tables detail the Group’s and the Company’s remaining contractual maturity for its
financial liabilities and lease liabilities. The table has been drawn up based on the undiscounted
cash flows of financial liabilities and lease liabilities based on the earliest date on which the
Group can be required to pay. The maturity dates for financial liabilities are based on the agreed
repayment dates. The table includes both interest and principal cash flows.
The Group
As at December 31, 2024
Interest rate
On
demand
or within
3 months
3 months
to 1 year
1 year to 2
years T otal
Carrying
amounts
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Trade and other payables ..... – 13,041 – – 13,041 13,041
Amount due to the
Controlling Shareholder ..... – 28,333 – – 28,333 28,333
Bank borrowings ......... 2.30%-2.50% 673 1,087 43,382 45,142 44,013
Lease liabilities .......... 2.50%-4.65% 1,115 1,186 282 2,583 2,539
43,162 2,273 43,664 89,099 87,926
As at December 31, 2025
Interest rate
On
demand
or within
3 months
3 months
to 1 year
1 year to 2
years T otal
Carrying
amounts
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Trade and other payables ..... – 15,713 – – 15,713 15,713
Bank borrowings ......... 1.85%-1.95% 48,396 – – 48,396 48,100
Lease liabilities .......... 3.50%-4.45% 649 775 204 1,628 1,601
Redemption liabilities ....... 12.37%-16.12% – 143,919 1,094,666 1,238,585 1,159,018
64,758 144,694 1,094,870 1,304,322 1,224,432
APPENDIX I ACCOUNTANTS’ REPORT
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--- page 354 ---
The Company
As at December 31, 2024
Interest rate
On
demand
or within 3
months
3 months
to 1 year
1 year to 2
years T otal
Carrying
amounts
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Trade and other payables ..... – 3,652 – – 3,652 3,652
Amount due to the
Controlling Shareholder ..... – 28,333 – – 28,333 28,333
Bank borrowings ......... 2.30%-2.50% 673 1,087 43,382 45,142 44,013
Lease liabilities .......... 2.50%-4.45% 832 339 – 1,171 1,165
33,490 1,426 43,382 78,298 77,163
As at December 31, 2025
Interest rate
On
demand
or within
3 months
3 months
to 1 year
1 year to 2
years T otal
Carrying
amounts
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
Trade and
other payables .......... – 9,409 – – 9,409 9,409
Amount due to a subsidiary .... – 26,500 – – 26,500 26,500
Bank borrowings ......... 1.85%-1.95% 48,396 – – 48,396 48,100
Lease liabilities .......... 3.50%-4.45% 367 775 204 1,346 1,321
Redemption liabilities ....... 12.37%-16.12% – 143,919 1,094,666 1,238,585 1,159,018
84,672 144,694 1,094,870 1,324,236 1,244,348
(c) Fair value measurements of financial instruments
Some of the Group’s financial instruments are measured at fair value for financial reporting
purposes. In estimating the fair value, the Group uses market-observable data to the extent it is
available.
(i) Fair value of the Group’s financial assets that are measured at fair value on a recurring
basis
Some of the Group’s and the Company’s financial assets are measured at fair value at the
end of each reporting period.
The following table gives information about how the fair values of these financial assets
are determined (in particular, the valuation technique(s) and inputs used).
The Group
Fair value at
December 31, Fair value
hierarchy
V aluation techniques
and key inputsFinancial assets 2024 2025
RMB’000 RMB’000
Financial assets at FVTPL . . 54,611 95,209 Level 2 Discounted cash flow.
Future cash flows are
estimated based on
discount rate observed
in the contract and
available market
information.
APPENDIX I ACCOUNTANTS’ REPORT
– I-43 –


--- page 355 ---
The Company
Fair value at
December 31, Fair value
hierarchy
V aluation techniques
and key inputsFinancial assets 2024 2025
RMB’000 RMB’000
Financial assets at FVTPL . . 20,056 95,209 Level 2 Discounted cash flow.
Future cash flows are
estimated based on
discount rate observed
in the contract and
available market
information.
(ii) Fair value of the Group’s financial assets and financial liabilities that are not measured
at fair value on a recurring basis (but fair value disclosures are required)
The Directors consider that the carrying amounts of financial assets and financial
liabilities recorded at amortized cost in the Historical Financial Information approximate
their respective fair values at the end of each reporting period.
33. RECONCILIATION OF LIABILITIES ARISING FROM FINANCING ACTIVITIES
The table below details changes in the Group’s liabilities arising from financing activities, including both
cash and non-cash changes. Liabilities arising from financing activities are those for which cash flows
were, or future cash flows will be, classified in the Group’s consolidated statements of cash flows as cash
flows from financing activities.
Bank
borrowings
Lease
liabilities
Cash
received in
respect of
restricted-
shares
Amount
due to the
Controlling
Shareholder
Redemption
liabilities
Accrued
issue cost T otal
RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000 RMB’000
At January 1, 2024 ........ 19,200 7,433 – 28,333 745,048 – 800,014
Financing cash flows ....... 24,144 (3,021) –––– 21,123
New leases entered ....... – 2 87–––– 2 87
Reclassification to capital reserve –––– (782,130) – (782,130)
Early termination of a lease . . . – (2,362) –––– (2,362)
Foreign exchange adjustments . . – – – – 307 – 307
Finance costs recognized . . . . 669 202 – – 36,775 – 37,646
At December 31, 2024 ...... 44,013 2,539 – 28,333 – – 74,885
Financing cash flows ....... 3,102 (3,972) 7,268 (28,333) – (1,330) (23,265)
New leases entered ....... – 2,968–––– 2,968
Recognition of redemption
liabilities ........... –––– 1,137,266 – 1,137,266
Deferred issue costs recognized . ––––– 2,435 2,435
Gain on non-substantial
modification of redemption
liabilities ........... –––– (42,081) – (42,081)
Foreign exchange adjustments . . –––– (2,119) – (2,119)
Finance costs recognized . . . . 985 66 – – 65,952 – 67,003
At December 31, 2025 ...... 48,100 1,601 7,268 – 1,159,018 1,105 1,217,092
APPENDIX I ACCOUNTANTS’ REPORT
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--- page 356 ---
34. RELATED PARTIES’ TRANSACTIONS
Other than the transactions and balances with related parties disclosed in Note 23, the Group has the
following transactions and balances with the related parties during the Track Record Period.
Compensation of key management personnel
The remuneration of directors and other member of key management personnel of the Group during the
Track Record Period was as follows:
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Salaries and allowance ............................ 5,619 8,392
Discretionary bonuses ............................. 1,186 1,834
Retirement benefits .............................. 2 0 6 3 0 0
7,011 10,526
The remuneration of directors and key executives is determined by the remuneration committee having
regard to the performance of individuals and market trends.
35. PARTICULARS OF SUBSIDIARIES
General information of subsidiaries
During the Track Record Period and as at the date of this report, the Company has direct and indirect
shareholding interests in the following subsidiaries:
Shareholding interest
attributable the Company as at
Place/date of
establishment
Issued and fully
paid capital/
registered
capital
December 31,
As at
the date
of this
report Principal activities2024 2025
%%%
Directly held:
Shanghai Xitaili (Note a) ...... PRC
November 22,
2022
RMB28,683,333/
RMB33,683,333
89.06 89.06 89.06 Medical and cellular
technology research and
development (“ R&D”),
technical services, and
sales of medical
equipment
Suzhou Pharmaceutical (Note a) . . PRC
September 2,
2022
RMB10,000,000/
RMB10,000,000
100 100 100 Medical and engineering
technology R&D,
technology services and
transfers, and sales of
medical equipment
Micot (Suzhou) Technology
Co., Ltd.* (Ҧ
ʮ̡) (“Suzhou T echnology ”)
(Note a) .............
PRC
August 20,
2020
RMB80,000,000/
RMB80,000,000
100 100 100 Medical research and
experimental
development; technology
services, development,
consultation, exchange,
transfer, and promotion
Xi’an Biocare (Note a) ....... PRC
August 11,
2017
RMB48,000,000/
RMB60,000,000
100 100 100 Biopharmaceutical R&D,
manufacturing, and
commercial distribution
Micot Taizhou (Note a) ....... P R C
May 16, 2025
RMB45,700,000/
RMB50,000,000
N/A 100 100 Medical R&D, and drug
production, clinical trial
services and distribution
Micot (Hong Kong) Technology
Limited (ಥ
ʮ̡ ) (“Micot HK”)
(Note c) .............
Hong Kong
October 29,
2021
HK$10,000/
HK$10,000
100 100 100 Pharmaceuticals and
medical devices R&D,
production, promotion
and distribution
Indirectly held:
Micot (U.S.) Technology Co., Ltd
(ʮ̡)
(Note b) .............
The U.S.
November 29,
2021
USD20,000/
USD20,000
100 100 100 Overseas R&D and
operations
APPENDIX I ACCOUNTANTS’ REPORT
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--- page 357 ---
Shareholding interest
attributable the Company as at
Place/date of
establishment
Issued and fully
paid capital/
registered
capital
December 31,
As at
the date
of this
report Principal activities2024 2025
%%%
Micot (U.S.) Biopharmaceutics
Co., Ltd (਷ ᔼᖹ
ʮ̡) (Note b) ........
The U.S.
September 21,
2022
USD1,000/
USD1,000
100 100 100 Overseas R&D and
operations
Notes:
(a) No statutory financial statements were required for the subsidiaries in the PRC since there are no
statutory audit requirements in the PRC.
(b) No audited financial statements of these subsidiaries have been prepared since its date of
incorporation as it is incorporated in the jurisdiction where there are no statutory audit
requirements.
(c) The statutory financial statements of Micot HK for the years ended December 31, 2024 and 2025
are not yet due to be issued.
* English name for identification purpose only
Details of a non-wholly owned subsidiary that have material non-controlling interests
The table below shows details of a non-wholly-owned subsidiary of the Group that have material
non-controlling interests:
Name of subsidiary
Place of
incorporation
and principal
place of
business
Proportion of ownership
interests and voting
rights held by
non-controlling interests
Loss allocated to
non-controlling interests
for the year ended
Accumulated
non-controlling interests
December 31, December 31, As at December 31,
2024 2025 2024 2025 2024 2025
% % RMB’000 RMB’000 RMB’000 RMB’000
Shanghai Xitaili ....... P R C 10.94 10.94 (2,200) (2,407) 14,982 12,575
(2,200) (2,407) 14,982 12,575
Summarized financial information in respect of the Group’s subsidiary that has material non-controlling
interests is set out below. The summarized financial information below represents amounts before
intragroup eliminations.
As at December 31,
2024 2025
RMB’000 RMB’000
Current assets ................................. 9,209 5,845
Non-current assets .............................. 2,688 2,060
Current liabilities ............................... 35,890 47,907
Equity attributable to owners of the Company ............. (38,975) (52,577)
Non-controlling interests .......................... 14,982 12,575
APPENDIX I ACCOUNTANTS’ REPORT
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--- page 358 ---
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Other income .................................. 2 0 4 3
Other gains and losses ............................ 3 9 –
Expenses .................................... (20,177) (22,052)
Loss for the year ................................ (20,118) (22,009)
Loss attributable to owners of the Company .............. (17,918) (19,602)
Loss attributable to the non-controlling interests ........... (2,200) (2,407)
For the year ended
December 31,
2024 2025
RMB’000 RMB’000
Net cash outflow from operating activities ............... (31,161) (7,106)
Net cash outflow from investing activities ................ (25) (50)
Net cash inflow from financing activities ................ 9,000 6,000
Net cash outflow ................................ (22,186) (1,156)
36. MAJOR NON-CASH TRANSACTIONS
The Group and the Company
During the years ended December 31, 2024 and 2025, the Group entered into new lease agreements for the
use of leased properties for 2 years. On the lease commencements, the Group recognized right-of-use
assets and lease liabilities of RMB287,000 each in 2024, and RMB2,968,000 each in 2025, respectively.
In addition, during the year ended December 31, 2024, the Group early terminated a lease, resulting in
the derecognition of right-of-use assets of RMB1,949,000 and lease liabilities of RMB2,362,000. A gain of
RMB414,000 was recognized in the profit or loss (Note 7).
37. SUBSEQUENT EVENTS
Save as elsewhere disclosed in this report, events and transactions took place subsequent to December 31,
2025 are detailed as below:
a) On February 4, 2026, the Company entered into an agreement with Everest Medicines (China) Co.,
Ltd. (ʮ̡) (“Everest”), pursuant to which the Company irrevocably
granted Everest an exclusive license to commercialize MT1013 in China and Asia-Pacific
(excluding Japan). MT1013 has entered Phase III clinical trial in China and the relevant
development expenses will be covered by the Group.
The Company received a non-refundable upfront payment of RMB200,000,000 in February 2026
and recognized it as a contract liability.
b) Pursuant to the resolutions of the shareholders meeting dated April 2, 2026, the shares had been
split on a one-for-fifty basis, and the nominal value of the shares had been changed from RMB1.0
each to RMB0.02 each, details of which are set out in the section headed “History, Development
and Corporate Structure — Share Subdivision before the Listing” in the Prospectus.
38. SUBSEQUENT FINANCIAL STATEMENTS
No audited financial statements of the Company, any of its subsidiaries or the Group have been prepared
in respect of any period subsequent to December 31, 2025.
APPENDIX I ACCOUNTANTS’ REPORT
– I-47 –


--- page 359 ---
The information set out in this Appendix does not form part of the accountants’ report on
the historical financial information of the Group for each of the two years ended December 31, 2025
(the “ Accountants’ Report ”) prepared by Deloitte Touche Tohmatsu, Certified Public
Accountants, Hong Kong, the Reporting Accountants 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 the
section headed “Financial Information” in this prospectus and the Accountants’ Report set out in
Appendix I to this prospectus.
A. UNAUDITED PRO FORMA STATEMENT OF ADJUSTED CONSOLIDATED
NET TANGIBLE ASSETS (LIABILITIES) OF THE GROUP ATTRIBUTABLE TO
OWNERS OF THE COMPANY
The following unaudited pro forma statement of adjusted consolidated net tangible
assets (liabilities) of the Group attributable to owners of the Company which has been
prepared in accordance with paragraph 4.29 of the Listing Rules is for illustration only,
and is set out to illustrate the effect of the proposed Global Offering (as defined in this
prospectus) on the consolidated net tangible liabilities of the Group attributable to owners
of the Company as at December 31, 2025 as if the Global Offering had taken place on such
date.
The unaudited pro forma statement of adjusted consolidated net tangible assets
(liabilities) of the Group attributable to owners of the Company 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 (liabilities) of the Group attributable to
owners of the Company had the Global Offering been completed as at December 31, 2025
or as at any subsequent dates following the Global Offering.
The following unaudited pro forma statement of adjusted consolidated net tangible
assets (liabilities) of the Group attributable to owners of the Company is prepared based
on the audited consolidated net tangible liabilities of the Group attributable to owners of
the Company as at December 31, 2025 as derived from the Accountants’ Report as set out
in Appendix I to this prospectus, and adjusted as described below:
Audited
consolidated
net tangible
liabilities of
the Group
attributable
to the owners
of the
Company as
at December
31, 2025
Estimated
net proceeds
from the
Global
Offering
Unaudited
pro forma
adjusted
consolidated
net tangible
(liabilities)
assets of the
Group
attributable
to the owners
of the
Company as
at December
31, 2025
Unaudited pro forma
adjusted consolidated
net tangible (liabilities)
assets of the Group
attributable to the owners of
the Company per Share as at
December 31, 2025
RMB’000 RMB’000 RMB’000 RMB HK$
Note 1 Note 2 Note 3 Note 4
Based on the Offer Price of
HK$18.2 per H Share .... (972,460) 870,630 (101,830) (0.32) (0.37)
Based on the Offer Price of
HK$21.0 per H Share .... (972,460) 1,006,248 33,788 0.11 0.12
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-1 –


--- page 360 ---
Notes:
(1) The amount is based on the audited consolidated net tangible liabilities of the Group attributable
to owners of the Company as at December 31, 2025 of RMB972,460,000, extracted from the
Accountants’ Report of the Group set out in Appendix I to this prospectus.
(2) The estimated net proceeds from the issue of Offer Shares pursuant to the Global Offering are
based on 58,054,400 Shares at the Offer Price of HK$18.2 (equivalent to RMB15.8) and HK$21.0
(equivalent to RMB18.3) per Offer Share, after deduction of underwriting fees and commissions
and other listing related expenses paid or payable by the Company (excluding listing expenses
recognised in profit or loss prior to December 31, 2025). The calculation of such estimated net
proceeds does not take into account any Shares (i) which may be allotted and issued upon the
exercise of the Over-Allotment Option, (ii) which may be allotted and issued pursuant to the
grant of awards under the Share Incentive Scheme, or (iii) which may be allotted and issued or
repurchased by the Company under the general mandates for the allotment and issue or
repurchase of Shares granted to the directors of the Company.
For the purpose of calculating the estimated net proceeds from the Global Offering, the amount
denominated in HK$ has been converted into RMB at the rate of HK$1 to RMB0.87005, which was
the exchange rate prevailing on June 7, 2026 with reference to the rate published by the People’s
Bank of China. No representation is made that the HK$ amounts have been, could have been or
could be converted to RMB, or vice versa, at that rate or at any other rates or at all.
(3) The unaudited pro forma adjusted consolidated net tangible liabilities of the Group attributable
to owners of the Company as at December 31, 2025 per Share is arrived at on the basis of
316,740,350 Shares in total, comprising 258,685,950 Shares in issue as at December 31, 2025 (after
the effect of the Subdivision), and 58,054,400 H Shares to be issued pursuant to the Global
Offering, assuming that Share Subdivision and the Global Offering had been completed on
December 31, 2025 and without taking into account any Shares (i) which may be allotted and
issued upon the exercise of the Over-Allotment Option, (ii) which may be allotted and issued
pursuant to the grant of awards under the Share Incentive Scheme, or (iii) which may be allotted
and issued or repurchased by the Company under the general mandates for the allotment and
issue or repurchase of Shares granted to the directors of the Company, or (iv) the 15,000,000 shares
(after the effect of the Subdivision) held for Share Incentive Scheme, which represent treasury
shares held by the Company.
(4) For the purpose of the unaudited pro forma adjusted consolidated net tangible assets (liabilities)
of the Group attributable to owners of the Company as at December 31, 2025 per Share, the
amount denominated in RMB has been converted into HK$ at the rate of RMB0.87005 to HK$1,
which was the exchange rate prevailing on June 7, 2026 with reference to the rate published by the
People’s Bank of China. No representation is made that the RMB amounts have been, could have
been or may be converted to HK$, or vice versa, at that rate or any other rates or at all.
(5) No adjustment has been made to the unaudited pro forma adjusted consolidated net tangible
assets (liabilities) of the Group attributable to owners of the Company as at December 31, 2025 to
reflect any trading result or other transactions of the Group entered into subsequent to December
31, 2025. In particular, the unaudited pro forma adjusted consolidated net tangible liabilities of
the Group attributable to owners of the Company as shown on II-1 have not been adjusted to
illustrate the effect of the termination of the redemption and other preferential rights granted to
the investors of Series A, B, B1, C and D Financings upon completion of the Global Offering
(“ T ermination of Preferential Rights ”), which would result in the reclassification of the
redemption liabilities with carrying amount of RMB1,159,018,000 as at December 31, 2025 to
equity.
Assuming the Series D Financing, Termination of Preferential Rights, Share Subdivision and
Global Offering had been completed on December 31, 2025, the unaudited pro forma adjusted
consolidated net tangible liabilities of the Group attributable to owners of the Company would
have adjusted by RMB1,159,018,000, resulting in unaudited pro forma adjusted consolidated net
tangible assets of the Group attributable to the owners of the Company of RMB1,057,188,000 and
RMB1,192,806,000, based on an Offer Price of HK$18.2 and HK$21.0 per H Share, respectively. The
unaudited pro forma adjusted consolidated net tangible assets of the Group attributable to
owners of the Company as at December 31, 2025 per Share after Termination of Preferential Rights
would have been RMB3.34 per Share (approximately HK$3.84 per Share) and RMB3.77 per Share
(approximately HK$4.33 per Share), respectively, calculated on the basis of 316,740,350 Shares in
issue and based on an Offer Price of HK$18.2 and HK$21.0 per H Share.
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-2 –


--- page 361 ---
The following is the text of the independent reporting accountants’ assurance report
received from Deloitte Touche Tohmatsu, Certified Public Accountants, Hong Kong, the reporting
accountants of the Company, in respect of the Group’s unaudited pro forma financial information
prepared for the purpose of incorporation in this prospectus.
B. INDEPENDENT REPORTING ACCOUNTANTS’ ASSURANCE REPORT ON
THE COMPILATION OF UNAUDITED PRO FORMA FINANCIAL
INFORMATION
T o the Directors of Shaanxi Micot Pharmaceutical T echnology Co., Ltd.
We have completed our assurance engagement to report on the compilation of
unaudited pro forma financial information ofʮ̡ (Shaanxi
Micot Pharmaceutical Technology Co., Ltd.) (the “ Company ”) and its subsidiaries
(hereinafter collectively referred to as the “ Group”) by the directors of the Company (the
“Directors”) for illustrative purposes only. The unaudited pro forma financial
information consists of the unaudited pro forma statement of adjusted consolidated net
tangible assets (liabilities) as at December 31, 2025 and related notes as set out on pages
II-1 to II-2 of Appendix II to the prospectus issued by the Company dated June 15, 2026
(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 Appendix II to the Prospectus.
The unaudited pro forma financial information has been compiled by the Directors
to illustrate the impact of the Global Offering (as defined in the Prospectus) on the
Group’s financial position as at December 31, 2025 as if the Global Offering had taken
place at December 31, 2025. As part of this process, information about the Group’s
financial position has been extracted by the Directors from the Group’s historical financial
information for each of the two years ended December 31, 2025, on which an accountants’
report set out in Appendix I to the Prospectus has been published.
Directors’ Responsibilities 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 (the “ HKICPA”).
Our Independence and Quality Management
We have complied with the independence and other ethical requirements of the
“Code of Ethics for Professional Accountants” issued by the HKICPA, which is founded
on fundamental principles of integrity, objectivity, professional competence and due care,
confidentiality and professional behavior.
Our firm applies Hong Kong Standard on Quality Management (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 and procedures regarding compliance with ethical requirements,
professional standards and applicable legal and regulatory requirements.
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-3 –


--- page 362 ---
Reporting Accountants’ 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 accountants plan and perform 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 an
investment circular is solely to illustrate the impact of a significant event or transaction on
unadjusted financial information of the Group 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
event or transaction at December 31, 2025 would have been as presented.
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 accountants’ judgment, having
regard to the reporting accountants’ understanding of the nature of the Group, 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.
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-4 –


--- page 363 ---
Opinion
In our opinion:
(a) the unaudited pro forma financial information has been properly compiled on
the basis stated;
(b) such basis is consistent with the accounting policies of the Group; and
(c) the adjustments are appropriate for the purposes of the unaudited pro forma
financial information as disclosed pursuant to paragraph 4.29(1) of the Listing
Rules.
Deloitte T ouche T ohmatsu
Certified Public Accountants
Hong Kong
June 15, 2026
APPENDIX II UNAUDITED PRO FORMA FINANCIAL INFORMATION
– II-5 –


--- page 364 ---
The Articles of Association, which is adopted by the shareholders in the general
meeting held on September 19, 2025, will become effective on the date that the H shares of
the Company are listed on the Stock Exchange. The primary purpose of this appendix is to
provide potential investors with an overview of the Articles of Association of the
Company. Accordingly, it may not contain all the information that may be considered
material or relevant by potential investors.
1. DIRECTORS AND BOARD OF DIRECTORS
(1) Power to allocate and issue shares
The Articles of Association provide that the shareholders may authorize the
board of directors through a general mandate at a general meeting to allocate or
issue shares of no more than 20% of all outstanding shares. The board of directors
shall prepare suggestions for share allotment or issue, which are subject to approval
by the shareholders at the general meeting in the form of a special resolution.
Any such allotment or issue shall be in accordance with the procedures
stipulated in appropriate laws, administrative regulations and supervision rules of
shares listed region.
(2) Power to dispose assets of the Company or any subsidiary
The sale of substantial assets that exceeds 30% of total assets of the latest
audited financial statement are subject to approval by the shareholders at the
general meeting in the form of a special resolution. The boards of directors may
decide on the disposal of assets of the Company as authorized by the shareholders
in a general meeting.
(3) Emoluments or compensation for directors’ loss of office
If a director is removed before the expiration of his term of office without due
cause, the director may claim for damages from the Company.
(4) Provide financial assistance for acquiring the shares of the Company
The Company or its subsidiaries (including affiliates of the Company) shall
not provide any financial assistance in the form of gifts, advances, guarantees,
compensation or loans for the acquisition of the Company’s or its parent company’s
shares by third parties, except for employee shareholding schemes.
The Company may provide financial assistance for the acquisition of the
Company’s or its parent company’s shares by third parties provided that such
financial assistance is for the benefit of the Company and has been duly approved
either by a resolution of shareholders in general meeting or by a resolution of the
board of directors acting pursuant to authority granted under the Articles of
Association or by shareholders. The aggregate amount of any such financial
assistance shall in no event exceed 10% of the Company’s total issued share capital.
Any resolution of the board of directors approving such financial assistance must be
passed by a super majority of not less than two-thirds of all directors then in office.
(5) Disclosure of interests in contracts with the Company and/or its affiliates
No director shall, without prior disclosure to and approval by either the board
of directors or the general meeting in accordance with the Articles of Association,
directly or indirectly enter into any contract or transaction with the Company.
(6) Remuneration
The remuneration of directors shall be approved by the shareholders at the
general meeting in the form of an ordinary resolution.
(7) Appointment, resignation and dismissal
The board of directors consists of nine directors, including executive
directors, non-executive directors and independent non-executive directors.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-1 –


--- page 365 ---
Directors are elected or replaced by the general meeting. The general meeting
may remove any director whose term has not expired by an ordinary resolution
without affecting any claim for damages that may be made pursuant to any contract,
provided that such removal is in compliance with relevant laws and regulations.
The board of directors has one chairman. The chairman of the board shall be
elected and dismissed by a vote of more than one half of the directors.
The term of office of a director shall be calculated from the date of assumption
of office until the expiration of the current term of office of the board of directors,
which is a three-year term. Upon expiration of the term, the director may be
re-elected in accordance with the relevant regulatory rules where the Company’s
shares are listed.
In the event a director is not re-elected in time for the expiration of his/her
term of office, or if a director resigns during his/her term of office, resulting in the
number of the board of directors being less than the minimum number required by
law, before the re-elected director assumes his/her office, the original director shall
still perform the duties of a director in accordance with the provisions stipulated by
laws, administrative regulations, departmental rules, and the Articles of
Association.
In the event a director resigns, the director shall notify the Company in
writing, and the resignation shall take effect on the date the Company receives the
notification; however, if the circumstances set forth in the preceding paragraph
exist, the director shall continue to perform the duties.
None of the following persons shall serve as our director:
i. A person who has no civil capacity or has limited civil capacity;
ii. A person who has been imposed penalty for the offense of corruption,
bribery, embezzlement, larceny, disrupting the socialist economic order
or has been deprived of political rights because of this conviction and is
within five years of the expiry date of the sentence; in the case of a
probation, less than two years have elapsed since the date of expiration
of the probationary period;
iii. A person who is a former director, factory manager or general manager
of a company or enterprise that is bankrupt and liquidated, was
personally liable for the bankruptcy of such company or enterprise, and
is within three years of the date of completion of bankruptcy and
liquidation of such company or enterprise;
iv. A person who has served as the legal representative of a company or
enterprise whose business license was revoked or was ordered to close
due to violation of laws, was personally liable, and is within three years
of the date on which the business license of such company or enterprise
was revoked;
v. A person listed by the people’s court as dishonest judgment debtors,
who has a relatively large sum of debt, which was not paid at maturity;
vi. A person who is prohibited by relevant securities regulator from
entering into the securities market and is still in such prohibition
period; or
vii. A person who has been publicly determined by the stock exchange to be
not suitable to serve as a director or senior management of a listed
company, and the period has not elapsed; or
viii. Any other person who is otherwise not eligible under laws,
administrative regulations, regulatory documents and other conditions
set out by the Listing Rules.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-2 –


--- page 366 ---
The election, appointment or engagement of a director shall be invalid if such
election, appointment or engagement violates the above-mentioned provisions. If a
director falls into the situations provided in the above-mentioned situations during
their term of office, they would be dismissed by the Company.
(8) Borrowing powers
The Articles of Association do not contain any specific provisions regarding
directors’ power of borrowing money.
The board of directors shall be entitled to develop proposals for the Company
to issue bonds and to list its Shares, and that such bond issues must be approved by
the shareholders by a special resolution at the general meeting.
2. MODIFICATION OF THE ARTICLE OF ASSOCIATION
The Company may amend the Articles of Association based on the provisions of the
laws, administrative regulations and Articles of Association.
In the event that the amendments to the Articles of Association passed by a general
meeting need the examination and approval of the competent authorities, these
amendments shall be submitted hereto for approval. Where the amendment of the Articles
of Association involves registration, it shall be necessary to carry out the lawfully
prescribed procedures for registration change.
3. SPECIAL RESOLUTIONS NEEDED TO BE ADOPTED BY ABSOLUTE
MAJORITY VOTE
The resolutions of the general meeting shall be divided into ordinary resolutions
and special resolutions.
An ordinary resolution may be adopted by a simple majority of the votes held by the
shareholders (including proxies of shareholders) attending the general meeting.
A special resolution can be adopted by a two-thirds majority of the votes held by the
shareholders (including proxies of shareholders) attending the general meeting.
4. VOTING RIGHTS
When shareholders (including proxies) vote at the general meeting, they exercise
their voting rights based on the number of voting shares they represent, and each share
has one voting right. When voting, shareholders (including proxies) holding two or more
votes are not required to cast all their votes in favour, against or as abstentions.
The shares held by the Company itself shall have no voting right and shall not be
counted in the total number of voting shares at the general meeting.
Any shareholder who is required by the Listing Rules to abstain from voting on a
matter or is limited to an affirmative or negative vote shall abstain from voting or be
required to so vote; any vote cast by or on behalf of relevant shareholder which is cast in
violation of such requirement or restriction shall not be counted in the voting result.
5. RULES ON ANNUAL GENERAL MEETINGS
The general meetings are divided into an annual general meeting and an
extraordinary general meetings. The annual general meeting shall be convened once a
year and be held within six months of the end of the previous fiscal year.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-3 –


--- page 367 ---
6. ACCOUNTS AND AUDITS
(1) Financial and accounting policies
The Company shall develop its financial accounting policies pursuant to laws,
administrative regulations and rules developed by the competent department.
The Company shall publish the financial reports twice in each accounting
year. Interim financial reports shall be published within 2 months of the end of the
first six months of a fiscal year, while the annual financial report shall be published
within 4 months of the end of each accounting year.
(2) Appointment and dismissal of accountants
The Company shall engage a reputable accounting firm that meets
appropriate requirements of the relevant laws, regulations and regulatory
requirements to be responsible for auditing its annual financial report, conduct
accounting statement audit, net asset verification and other related consulting
services, and the term of service shall be one year, which is renewable upon expiry
of the term.
The appointment and removal of an accounting firm providing regular audit
services to the Company shall be determined by resolution of the shareholders in
general meeting.
Prior to the removal or the non-reappointment of an accounting firm, notice of
such removal or non-reappointment shall be given to the firm concerned 30 days in
advance and such firm shall be entitled to make representation at the general
meeting when voting on the dismissal of such firm at the general meeting.
In the event the accounting firm resigns from its post, it shall make clear to the
general meeting whether there has been any impropriety on the part of the
Company.
If the position of an appointed accounting firm is vacant, the board of
directors may appoint an accounting firm before the start of general meeting.
However, if during the vacant period, the Company has other incumbent accounting
firm, such accounting firm may take the vacant.
7. NOTICE AND AGENDA OF GENERAL MEETINGS
Under any of the following circumstances, the board of directors shall convene an
extraordinary general meeting within two months:
i. The number of directors is less than the number specified in the Company
Law or less than two thirds of the number required in the Articles of
Association;
ii. The uncovered losses of the Company reach one-third of its total paid-in
registered capital;
iii. The shareholders with 10% or more shares of the Company (including
preference shares with restored voting rights) separately or jointly request to
convene an extraordinary general meeting in writing;
iv. The board of directors considers it necessary;
v. The audit committee makes such proposal;
vi. Any other circumstances stipulated in laws, regulations, the Articles of
Association.
In the event that the general meeting is convened, the board of directors and
shareholders who separately or jointly hold more than 1% of the shares of the Company
(including preference shares with restored voting rights) may submit a proposal.
When convening an annual general meeting, the Company shall notify shareholders
by announcement 21 days before it is convened. When convening an extraordinary
general meeting, the Company shall send a written notice 15 days before it is convened.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-4 –


--- page 368 ---
The notice of the general meeting shall be made in writing, including the following
contents:
i. The time, venue, and duration of the meeting;
ii. The matters and proposals to be discussed at the meeting;
iii. Conspicuous statement that all shareholders are entitled to attend the meeting
and appoint proxy to attend and vote and that proxy need not be a
shareholder;
iv. The date of shareholding registration for the shareholders who are entitled to
attend the meeting;
v. The name and telephone number of the contact person for the meeting;
vi. The voting time and voting procedure for internet or other alternative voting
methods;
vii. Other requirements stipulated by laws, administrative regulations,
department rules, Listing Rules.
The notice of general meeting and any supplementary notice shall contain full and
complete disclosure of all substantive details of every proposed resolution.
The resolution of the general meeting includes ordinary resolution and special
resolution. The following matters shall be approved by the general meeting through
ordinary resolutions:
i. Work report of the board of directors;
ii. Plans of earnings distribution and loss make-up schemes drafted by the board
of directors;
iii. Appointment or dismissal of the members of the board of directors and their
enumeration and payment methods;
iv. Other matters other than those approved by special resolution stipulated in
the laws, administrative regulations, Listing Rules or the Articles of
Association.
The following matters shall be approved by special resolution at the general
meeting:
i. The increase or decrease of the registered capital;
ii. Division, split, merger, dissolution and liquidation of the Company;
iii. Amendment of the Articles of Association;
iv. The purchase or sale of material assets of the Company or provision of
guarantees to others by the Company within one year exceeding 30% of the
latest audited total assets of the Company;
v. Share incentive scheme;
vi. Other matters recognized by ordinary resolution of the general meeting that
could materially affect the Company and need to be approved by special
resolution or as required by the laws, administrative regulations, Listing
Rules or the Articles of Association.
In the event that any resolution of the general meeting or resolution of the board of
directors violates laws or administrative regulations, any shareholder is entitled to
request the court to deem it as invalid.
In the event that the convening procedure or voting formula of the general meeting
or meeting of the board of directors violates any of laws, administrative regulations or the
Articles of Association, or the content of resolution violates the Articles of Association,
any shareholder is entitled to request the court to revoke the relevant resolution within 60
days after the resolution was adopted, unless there is only a minor defect in the
procedures for convening a general meeting or a meeting of the board of directors or in the
manner of voting, which does not materially affect the resolution.
8. SHARES TRANSFERS
The shares issued before the public issuance of shares by the Company shall not be
transferred within one year of the date on which the stocks of the Company are listed and
traded on a stock exchange.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-5 –


--- page 369 ---
The directors and senior managements of the Company shall declare, to the
Company, information on their holdings of the shares of the Company and the changes
thereto. The shares transferable by them during each year of their term of office shall not
exceed 25% of the total shares of the Company held by them. The shares of the Company
held by them shall not be transferred within one year of the date on which the stocks of the
Company are listed and traded on a stock exchange. The aforesaid persons shall not
transfer their shares of the Company within six months from the date of their resignation.
In the event the securities regulatory authorities in the place where the Company’s
shares are listed and CSRC (if applicable) have any other provisions on the transfer
restrictions of H shares, such provisions shall prevail.
9. POWERS OF OUR COMPANY TO REPURCHASE ITS SHARES
The Company shall not repurchase its shares except under any of the following
circumstances provided that such repurchase does not violate laws, regulations, the
Listing Rules, and the Articles of Association:
i. Reduce the Company’s registered capital;
ii. Merger with other companies which hold our shares;
iii. Granting shares to the staff of the Company as incentives;
iv. Requesting the Company to buy back its shares from shareholders who vote
against any resolution adopted at the general meeting concerning the merger
and division of the Company;
v. To convert shares into bond issued by the Company which is convertible to
stock of the Company;
vi. Necessary for the Company to maintain the Company’s value and
shareholders’ interests.
10. DIVIDEND AND OTHER DISTRIBUTION METHODS
The Company may distribute dividends in the manner of cash or stock.
The Company shall implement the specific distribution plan within six months after
the general meeting has passed a resolution on the profit distribution plan.
11. SHAREHOLDER PROXIES
Shareholders may attend the general meeting in person or authorize one or more
representatives, who is not a shareholder, to attend and vote on their behalf.
Any proxy statement issued by a Shareholder who authorizes a proxy to attend the
general meeting on his/her behalf shall include the following details:
i. the name or title of the appointer, class and number of the company shares
held;
ii. the name or title of the proxy;
iii. the shareholder’s specific instructions, including respective instructions on
for, against or abstention voting on each item for deliberation listed in the
general meeting agenda;
iv. the issuance date and valid period of the proxy statement;
v. the signature (or seal) of the appointer. Where the appointer is a corporate
shareholder, the corporate seal of the legal entity shall be affixed.
12. INSPECTION OF THE REGISTER OF SHAREHOLDERS
The Company establishes the register of Shareholders according to the certificate
provided by the securities registration authority. The register of Shareholders is sufficient
evidence to prove that the Shareholders hold the Company’s shares. Shareholders enjoy
rights and assume obligations according to the type and number of shares they hold.
Registered shareholders or prospective registrants who lose their shares may apply to the
Company for replacement certificates. Replacement applications by H-share shareholders
shall be handled in accordance with the laws, stock exchange rules and other relevant
provisions of the place where the original H-share register is kept.
Shareholders holding the same type of Shares shall enjoy the same rights and
undertake the same obligations.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-6 –


--- page 370 ---
The original register of the shareholders of the H Shares listed in Hong Kong shall
be kept in Hong Kong.
When the Company convenes the general meeting, pays dividends, goes into
liquidation or is involved in other actions that require the confirmation of identities, the
board of directors shall fix a date as the equity registration date, upon expiration of which
the shareholders whose names registered on the register of shareholders shall be the
shareholders entitled to relevant equity.
13. RIGHTS OF MINORITIES IN RELATION TO FRAUD OR OPPRESSION
If any director or senior management (other than a member of the Audit Committee)
violates laws, administrative regulations or the Articles of Association in fulfilling
his/her duties, thereby causing any loss to the Company, the shareholder(s) severally or
jointly holding 1% or more shares of the Company for more than 180 consecutive days
shall have the right to request the Audit Committee in writing to institute legal
proceedings at the People’s Court; if the member of the Audit Committee violates laws,
administrative regulations or the Articles of Association in fulfilling his/her duties,
thereby causing any loss to the Company, the aforementioned Shareholders shall have the
right to request the board of directors in writing to institute legal proceedings at the
People’s Court.
If the Audit Committee or the board of directors refuses to institute legal
proceedings after receipt of the aforesaid written request or fails to institute legal
proceedings within 30 days after receipt of the aforesaid written request, or if under
urgent circumstances that any delay of legal proceedings may cause irrecoverable
damages to the interests of the Company, the Shareholders specified above shall have the
right to directly institute legal proceedings at the People’s Court in their own names for
the interest of the Company.
If any other person infringes upon the legitimate rights and interests of the
Company, thereby causing any loss to the Company, the Shareholders specified in
paragraph 1 may institute legal proceedings at the People’s Court pursuant to the
preceding provisions.
Where a director or senior management of a wholly-owned subsidiary of the
Company violates laws and administrative regulations or the Articles of Association in
fulfilling his/her duties, thereby causing any loss to the Company, or where a third party
infringes upon the lawful rights and interests of such wholly-owned subsidiary thereby
causing losses, any shareholders who individually or jointly holding no less than 1% of
the Company’s shares for no less than 180 consecutive days shall have the right to submit
a written request to the Audit Committee or the board of directors of the wholly-owned
subsidiary to initiate legal proceedings with the People’s Court in accordance with the
relevant provisions of the Corporate Law or directly initiate legal proceedings with the
People’s Court in their own name.
If a wholly-owned subsidiary of the Company does not set up a board of supervisors
or does not have a supervisor, and sets up an Audit Committee instead, the relevant
procedure specified in paragraph 1 and 2 above shall be followed.
If any director or senior management violates the laws, administrative regulations
or the Articles of Association, thereby causing any loss to the Shareholders’ interests, the
Shareholders may institute legal proceedings at the People’s Court.
14. LIQUIDATION PROCEDURES
The Company shall be dissolved under any of the following circumstances:
(i) the expiration of the business period as stipulated in the Articles of
Association or the occurrence of other grounds for dissolution as stipulated in
the Articles of Association;
(ii) the general meeting resolves to dissolve the Company;
(iii) dissolution is necessary as a result of the merger or division of the Company;
(iv) the business license of the Company is revoked, or the Company is ordered to
be closed down, or it is deregistered according to law; and
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-7 –


--- page 371 ---
(v) the Company is confronted with serious difficulties in operation and
management, and its continued existence may cause material loss to the
interests of its shareholders, and the difficulties cannot be resolved through
other means, in which case the Shareholders holding 10% or more of the
voting rights held by all the Shareholders of the Company may request a
People’s Court to dissolve the Company.
Where any ground for dissolution as specified in the preceding paragraph arises in
respect of the Company, the Company shall within 10 days publish such ground for
dissolution via the National Enterprise Credit Information Publicity System.
Where the Company is to be dissolved pursuant to items (1), (2), (4) or (5) above, it
shall undergo liquidation. Directors shall act as the liquidation obligor and establish a
liquidation committee within 15 days from the date when the event of dissolution occurs.
The members of the liquidation committee shall be composed of the directors or the
personnel appointed by the general meeting.
Within 10 days of the establishment of the liquidation committee, the creditors shall
be notified and an announcement shall be published within 60 days. Creditors shall file
their claims with the liquidation committee within 30 days of receiving the notice, or
within 45 days from the publication if any such creditor has not received the notice.
After identifying the Company’s assets and preparing the balance sheet and
schedule of assets, the liquidation committee shall formulate a liquidation plan and
submit it to the general meeting or the People’s Court for confirmation.
Upon completion of the company’s liquidation, the liquidation committee shall
prepare a liquidation report, submit it to the general meeting or the People’s Court for
confirmation, and file it with the company registry to apply for deregistration of the
company.
15. OTHER IMPORTANT PROVISIONS FOR OUR COMPANY OR
SHAREHOLDERS
(1) General provisions
The Company is a permanently existing joint stock limited company.
According to the Articles of Association, any shareholder may bring a lawsuit
against another shareholder, a director, or the senior management, any shareholder
may bring a lawsuit against the Company, and the Company may bring a lawsuit
against any shareholder, director or the senior management.
(2) Capital increase and capital reduction
The Company may increase stock capital by the following means in
accordance with laws and regulations, subject to the approval by the general
meeting, for management and operation needs:
i. Issuing shares in a public offering;
ii. Issuing shares via a private placement;
iii. Giving bonus shares to existing shareholders;
iv. Converting reserve funds into shares; and
v . Other means approved by the laws, administrative regulations,
departmental rules and relevant regulatory authorities where the
Company’s shares are listed and the CSRC (if necessary).
The Company may decrease our registered capital and shall comply with the
procedures stipulated in Company Law of the PRC, the Listing Rules, other relevant
regulations and the Articles of Association.
(3) Shareholders
Shareholder is entitled to rights and assumes obligations pursuant to the
classification of his or her shares. Shareholder holding the same classified share has
the same rights and assumes the same obligations.
The rights of our ordinary shareholders are as follows:
i. To receive distribution of dividends and other forms of benefits
according to the number of shares held;
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-8 –


--- page 372 ---
ii. To legally require, convene, preside over, participate in or authorize
proxies of shareholders to participate in and exercise corresponding
voting rights at the general meeting;
iii. To supervise and manage business and operational activities of the
Company, and to provide suggestions or submit queries;
iv . To transfer, grant or pledge the Company’s shares he/she held
according to the provisions of the laws, administrative regulations,
regulatory rules where the Company’s shares are listed and the Articles
of Association;
v . To obtain relevant information according to the provisions of the
Articles of Association, including reading and coping the Articles of
Association, register of shareholders, minutes of general meetings,
resolutions of meetings of the board of directors; eligible Shareholders
may inspect the accounting books and accounting vouchers;
vi. To participate in the distribution of residual properties of the company
in proportion to the number of shares held in the event of the
termination or liquidation of the Company;
vii. To r equest the Company to buy back their shares as dissenting
shareholders voting against any resolutions adopted at the general
meeting concerning the merger and division the Company;
viii. Other rights conferred by laws, administrative regulations,
departmental rules, the Listing Rules, and the Articles of Association.
(4) The board of directors
The board of directors is responsible to the general meeting.
The board of directors exercises the following powers:
i. To convene the general meeting and report on its work to the general
meeting;
ii. Implement the resolutions of the general meeting;
iii. Determine the business and investment plans of the Company;
iv . Formulate the earnings distribution and loss offset plans of the
Company;
v. Formulate the proposals for increasing or decreasing the Company’s
registered capital, issuance of corporate bonds or other securities and
the listing plan of the Company;
vi. Prepare plans for major acquisition, stocks buy-back, corporate merger,
separation, dissolution and change corporate form of the Company;
vii. Determine, in accordance with the Articles of Association or within the
scope authorized by the general meeting, such matters as the
Company’s external investments, the purchase and sale of assets, asset
mortgages, external guarantees, entrusted management of finance,
related-party transactions and external donations;
viii. Decide on the setup of the Company’s internal management
organization;
ix. Appoint or dismiss the general manager, secretary of the board, and
other senior managers of the Company; based on the nomination of the
general manager, appoint or dismiss senior managements of the
Company such as deputy general manager, Chief financial officer (CFO)
and other senior managers and determine their remuneration, reward
and disciplinary matters;
x. Formulate the basic internal management systems of the Company;
xi. Review the compensation system and compensation structure of the
Company and/or its subsidiaries;
xii. Formulate the modification plan to the Articles of Association;
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-9 –


--- page 373 ---
xiii. Managing the information disclosure of the Company;
xiv . Make proposals to the general meeting on the appointment or
replacement of the accounting firm that provides audit services to the
Company;
xv . Listen to work report of general manager and inspect the general
manager’s work; and
xvi. Other powers and duties authorized by the laws, administrative
regulations, regulations of the authorities, the Listing Rules and the
Articles of Association.
Board meeting shall be held only if more than one half of the directors are
present. Unless otherwise provided in the Articles of Association, resolutions of the
board of directors shall be passed by a simple majority of all directors.
The board of directors of the Company shall give an explanation to the general
meeting on the non-standard audit report issued by the certified public accountants
on the financial reports of the Company.
(5) Independent non-executive director
At least one independent non-executive director shall have applicable
professional qualification or are equipped with applicable accounting or relevant
financial management expertise.
(6) Secretary of the board of directors
The Secretary of the board of directors, as a senior management officer of the
Company, shall be responsible for organizing the shareholders’ general meetings
and board meetings, maintaining corporate records, managing shareholder
information, and handling disclosure matters, while complying with all applicable
laws, administrative regulations, departmental rules, and the provisions of these
Articles of Association. The Company has one secretary of the board of directors.
(7) Audit committee
The Company shall set up an audit committee.
The audit committee consists of three directors.
The audit committee shall consist of directors who are not senior
managements of the company, among them there are two independent directors,
and an accounting professional among these independent directors shall act as the
convener.
The audit committee shall be responsible for review of the company’s
financial information and disclosure thereof, supervision and evaluation of internal
and external audit work and internal control. The following matters shall, upon
consent by more than half of all the members of the audit committee, be present to
board meeting for deliberation:
i. Disclosure of financial information in financial accounting reports and
periodic reports, internal control evaluation report;
ii. Engagement or dismissal of accounting firm which undertakes audit
business of a listed company;
iii. Engagement or dismissal of the financial controller of a listed company;
iv. Change in accounting policies or accounting estimates or correction of
material accounting error for a reason other than change in accounting
standards; and
v. Any other matters stipulated by laws, administrative regulations, the
CSRC and the articles of association.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-10 –


--- page 374 ---
(8) General manager
The Company has one general manager, appointed or dismissed by the board
of directors. The general manager of the Company is responsible to the board of
directors and exercises the following powers:
i. Be in charge of the producing and operational management of the
Company, organize the implement of resolutions of the board of
directors and report to the board of directors on his/her work;
ii. Organize the implementation of the Company’s annual operation plans
and investment schemes;
iii. Formulate the plans for establishment of the Company’s internal
management organization;
iv. Formulate the fundamental management policies of the Company;
v . Formulate the specific management regulations and rules of the
Company;
vi. Propose the board of directors of engagement or dismissal of the
Company’s deputy general manager, Chief financial officer and other
senior managements;
vii. Decide to engage or dismiss other managements except those who shall
be appointed or dismissed by the board of directors;
viii. Other responsibilities authorized by the Articles of Association and the
board of directors.
(9) Reserve fund
When the annual after-tax profits of the Company are distributed, the
Company shall allocate 10% of the profits to the statutory reserve fund of the
Company. Allocations to the Company’s statutory reserve fund may be waived once
the cumulative amount of funds therein exceeds 50% of the Company’s registered
capital.
If the Company’s statutory reserve fund is insufficient to offset our losses
during the previous year, the profits generated during the current year shall be used
to cover such losses before allocating the statutory reserve in accordance with the
requirements set forth above.
After allocation to the statutory reserve fund from the after-tax profits of the
Company, we may also allocate to the discretionary reserves fund will from after-tax
profits in line with the resolution(s) adopted at the general meeting.
After the Company has covered for its losses and made allocations to its
statutory reserve fund, the remaining profits are distributed in proportion to the
number of shares held by the shareholders, unless otherwise specified by the
Articles of Association.
If the general meeting violates the above provisions and profits are
distributed to the shareholders, the profits distributed in violation of the provisions
shall be returned by such shareholders to the Company. If the Company suffers
losses, the shareholders and responsible directors, senior managements shall be
liable for compensation.
The shares held by the Company itself shall not be subject to profit
distribution.
The Company’s reserve fund shall be used to offset losses of the Company,
expanding the scale of business and operations or for conversion into and increase
our capital.
Where reserve fund is used to offset loss of the Company, the discretionary
reserve fund and statutory reserve fund shall be firstly used; in the event they are
insufficient for offsetting loss, the capital reserve fund may be applied to cover the
company’s losses.
Where the statutory reserve fund converses into the registered capital, the
remaining statutory reserve shall not be less than 25% of the registered capital of the
Company before such conversion.
APPENDIX III SUMMARY OF ARTICLES OF ASSOCIATION
– III-11 –


--- page 375 ---
FURTHER INFORMATION ABOUT OUR GROUP
Incorporation of our Company
Our Company was established as a limited liability company in January 2007 under
the laws of the PRC and was converted into a joint stock limited company in January 2025.
Our registered office is located at Room B06, 26th Floor, Building 5, Digital China Science
and Technology Park, No. 20, Zhangba 4th Road, High-tech Development Zone, Xi’an,
Shaanxi, PRC.
Our Company has established a place of business in Hong Kong at 31/F, Tower Two,
Times Square, 1 Matheson Street, Causeway Bay, Hong Kong and has been registered as a
non-Hong Kong company in Hong Kong under Part 16 of the Companies Ordinance on
September 18, 2025. Mr. Zou Ran ( ཅ್) and Ms. Chan Yee Lam ( ௓ၥᔝ) have been
appointed as our authorized representatives for acceptance of service of process and
notices in Hong Kong, and their correspondence address is the same as our place of
business in Hong Kong.
As our Company was established in the PRC, we are subject to the relevant laws and
regulations of the PRC. A summary of the relevant provisions of our Articles of
Association is set out in Appendix III to this prospectus.
Changes in the Share Capital of our Company
The following sets out the changes in the share capital of our Company during the
two years immediately preceding the date of this prospectus:
(i) In March 2024, Junying Growth transferred 0.81% equity interest in our
Company, being 40,353 Shares, to Junying Jiacheng.
(ii) In January 2025, our Company was converted into a joint stock limited
company.
(iii) In September 2025:
(i) Linhai Qize injected RMB138.5 million into our Company in return for
287,653 Shares;
(ii) Maicheng Century injected RMB15.0 million into our Company in
return for 31,154 Shares;
(iii) Jinan Liuji injected RMB12.0 million into our Company in return for
24,923 Shares;
(iv) Shaanxi Jingang injected RMB30.0 million into our Company in return
for 62,308 Shares; and
(v) Shaanxi Innovation Relay injected RMB40.0 million into our Company
in return for 83,077 Shares.
For details of changes in the share capital of our Company, see “History,
Development and Corporate Structure.”
Changes in the Share Capital of our Subsidiaries
The list of our major subsidiaries is set out under the financial statements in the
Accountants’ Report as included in Appendix I to this prospectus. The following
alterations in the share capital of our subsidiaries have taken place within the two years
immediately preceding the date of this prospectus:
(i) On June 14, 2023, the registered share capital of Shanghai Xitaili increased
from RMB30.0 million to approximately RMB33.7 million.
(ii) On February 14, 2025, the registered share capital of Xi’an Biocare increased
from RMB9.6 million to RMB60.0 million.
(iii) On February 24, 2025, the registered share capital of Suzhou Technology
increased from RMB50 million to RMB80.0 million.
(iv) On March 3, 2026, the registered share capital of Suzhou Pharmaceutical
decreased from RMB238 million to RMB10 million.
Save as disclosed above, there had been no other alterations of share capital of our
subsidiaries within the two years preceding the date of this prospectus.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-1 –


--- page 376 ---
Resolutions of the Shareholders
Pursuant to a general meeting held on September 19, 2025, the Shareholders
resolved that, among others:
(a) the issuance by our Company of H Shares with a nominal value of RMB1.00
each (or with a nominal value of RMB0.02 each upon the completion of the
Share Subdivision) and such H Shares being listed on the Stock Exchange;
(b) the number of H Shares to be issued shall not be more than 25% of the total
issued share capital of our Company as enlarged by the Global Offering
(without taking into account of any H Shares which may be issued upon the
exercise of the Over-allotment Option), and the grant of the Over-allotment
Option in respect of not more than 15% of the number of H Shares initially
available under the Global Offering;
(c) subject to the CSRC’s approval, upon completion of the Global Offering,
222,016,700 Unlisted Shares in aggregate held by 24 Shareholders will be
converted into H Shares on a one-for-one basis;
(d) subject to the completion of the Global Offering, the conditional adoption of
the Articles of Association which shall become effective on the Listing Date,
and authorization to the Board to amend the Articles of Association to the
extent necessary in accordance with laws, regulations and regulatory rules
and requirements from relevant government bodies or regulatory authorities
and for the purpose of the Listing; and
(e) authorization of the Board or its authorized individual(s) to handle all matters
relating, among other things, to the Global Offering, the issue and the listing
of H Shares on the Stock Exchange.
FURTHER INFORMATION ABOUT OUR BUSINESS
Summary of Our Material Contracts
We have entered into the following contracts (not being contracts entered into in the
ordinary course of business) within the two years immediately preceding the date of this
prospectus that are or may be material:
(a) the Hong Kong Underwriting Agreement;
(b) the Deed of Indemnity;
(c) the cornerstone investment agreement dated June 9, 2026, entered into among
the Company, Everest Medicines Limited, CCB International Capital Limited
and China Merchants Securities (HK) Co., Limited with respect to a
subscription of H Shares at the Offer Price in the aggregate amount of
HK$100.00 million;
(d) the cornerstone investment agreement dated June 9, 2026, entered into among
the Company, Qiyuan High-tech Innovation Investment (Hong Kong) Limited
(ʮ̡), CCB International Capital Limited and
China Merchants Securities (HK) Co., Limited, with respect to a subscription
of H Shares at the Offer Price in the aggregate amount of HK$341.36 million;
(e) the cornerstone investment agreement dated June 9, 2026, entered into among
the Company, Summit Capital Limited (ʮ̡), CCB International
Capital Limited and China Merchants Securities (HK) Co., Limited, with
respect to a subscription of H Shares at the Offer Price in the aggregate
amount of HK$7.83 million;
(f) a capital contributions agreement dated June 27, 2025, entered into between,
amongst others, our Company and Linhai Qize, under which Linhai Qize
agreed to subscribe and our Company agreed to issued 287,653 Shares to
Linhai Qize at a total consideration of RMB138.5 million;
(g) a capital contributions agreement dated September 19, 2025, entered into
between, amongst others, our Company and Maicheng Century, under which
Maicheng Century agreed to subscribe and our Company agreed to issue
31,154 Shares to Maicheng Century at a total consideration of RMB15.0
million;
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-2 –


--- page 377 ---
(h) a capital contributions agreement dated September 19, 2025, entered into
between, amongst others, our Company and Jinan Liuji, under which Jinan
Liuji agreed to subscribe and our Company agreed to issue 24,923 Shares to
Jinan Liuji at a total consideration of RMB12.0 million;
(i) a capital contributions agreement dated September 24, 2025, entered into
between, amongst others, our Company and Shaanxi Jingang, under which
Shaanxi Jingang agreed to subscribe and our Company agreed to issue 62,308
Shares to Shaanxi Jingang at a total consideration of RMB30.0 million; and
(j) a capital contributions agreement dated September 26, 2025, entered into
between, amongst others, our Company and Shaanxi Innovation Relay, under
which Shaanxi Innovation Relay agreed to subscribe and our Company agreed
to issue 83,077 Shares to Shaanxi Innovation Relay at a total consideration of
RMB40.0 million.
Intellectual Property Rights
Trademarks
As of the Latest Practicable Date, we have registered the following trademarks,
which we consider to be material to our business:
No. T rademark Class Owner
Place of
Registration
Registration
No. Expiry date
1...
5 Our Company Hong Kong 306072822 September 29, 2032
2...
 42 Our Company PRC 78894863 November 20, 2034
3...
 10 Our Company PRC 78486854 December 20, 2034.
4...
 5 Our Company PRC 74424768 April 20, 2034
5...
 5 Our Company PRC 69265343 July 13, 2033
6...
 5 Our Company PRC 69258685 September 20, 2033
7...
 5 Our Company PRC 69257898 September 20, 2033
8...
 5 Our Company PRC 69260760 July 13, 2033
9...
 5 Our Company PRC 69266533 July 27, 2033
10 . .
 5 Our Company PRC 67566942 April 13, 2033
11 . .
 5 Our Company PRC 67549391 April 13, 2033
12 . .
 5 Our Company PRC 67548564 April 13, 2033
13 . .
 5 Our Company PRC 56176082 February 20, 2032
14 . .
 42 Our Company PRC 50739779 July 20, 2031
15 . .
 44 Our Company PRC 50572621 June 27, 2031
16 . .
 35 Our Company PRC 50578479 April 6, 2032
17 . .
 10 Our Company PRC 50582155 June 20, 2031
18 . .
 42 Our Company PRC 50577241 June 20, 2031
19 . .
 42 Our Company PRC 50560005 July 6, 2031
20 . .
 5 Our Company PRC 50576908A September 6, 2031
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-3 –


--- page 378 ---
No. T rademark Class Owner
Place of
Registration
Registration
No. Expiry date
21 . .
35 Our Company PRC 50549904 May 27, 2032
22 . .
 5 Our Company PRC 50578883A September 6, 2031
23 . .
 44 Our Company PRC 50549881 April 13, 2032
24 . .
 44 Our Company PRC 50562701 July 6, 2031
25 . .
 35 Our Company PRC 50582167 May 27, 2032
26 . .
 10 Our Company PRC 50577297 June 27, 2031
27 . .
 5 Our Company PRC 50556505 August 6, 2031
28 . .
 10 Our Company PRC 15078968 September 20, 2035
29 . .
 5 Our Company PRC 15078731 November 13, 2035
30 . .
 5 Our Company PRC 15078862 November 13, 2035
31 . .
 10 Shanghai Xitaili PRC 82995234 July 6, 2035
32 . .
 42 Shanghai Xitaili PRC 80060829 January 27, 2035
33 . .
 5 Shanghai Xitaili PRC 78907637 November 20, 2034
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-4 –


--- page 379 ---
Patents
As of the Latest Practicable Date, we had registered the following patents which we
considered to be material to our business:
No Owner Description Patent No.
Type of
Patents
Application
date
Authorization
announcement
date
1 . . Our Company Bispecific fusion polypeptide
compound
(ي)
CN202180014524.4 Invention April 20,
2021
September 26,
2023
2 . . Our Company Active polypeptide compound
(ي)
CN202080071421.7 Invention June 19,
2020
August 25,
2023
3 . . Our Company Multi-target compound
with anticoagulant and
antiplatelet activities,
its preparation method
and use
(ٙ׌ݺؐ
ձ͜௄)
CN202110662995.8 Invention August 5,
2015
November 8,
2022
4 . . Our Company Multi-target compound
with anticoagulant and
antiplatelet activities,
its preparation method
and use
(ٙ׌ݺؐ
ձ͜௄)
CN202110662996.2 Invention August 5,
2015
October 4,
2022
5 . . Our Company Multi-target compound with
anticoagulant and
antiplatelet activities,
its preparation method and
use
(ٙ׌ݺؐ
ձ͜௄)
CN202110661682.0 Invention August 5,
2015
October 4,
2022
6 . . Our Company Compound for treating
neurological diseases and its
application
(ʷ
ʿՉᏐ͜)
CN201910704350.9 Invention July 31,
2019
October 1,
2021
7 . . Our Company Multi-target compound
with anticoagulant and
antiplatelet activities,
its preparation method and
use
(ٙ׌ݺؐ
ձ͜௄)
CN201580082185.8 Invention August 5,
2015
July 13, 2021
8 . . Our Company Peptide for preventing and
treating acute coronary
syndrome and anticoagulant
and antithrombotic therapy,
and its application
(এၝ
ε㹻
ʿՉᏐ͜)
CN201110171267.3 Invention June 23,
2011
January 22,
2014
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-5 –


--- page 380 ---
No Owner Description Patent No.
Type of
Patents
Application
date
Authorization
announcement
date
9 . . Xi’an Biocare
Pharma Ltd.
Bile acid derivative salts, their
crystalline forms, and
preparation methods and
applications thereof
(ഐ
ձᏐ͜)
CN202180006768.8 Invention April 7,
2021
August 2, 2024
10 . . Xi'an Biocare
Pharma Ltd.
Compound for the treatment
of metabolic diseases,
its preparation method and
application
(ʷΥ
ձᏐ͜)
CN201810930184.X Invention August 15,
2018
October 30,
2020
Domain names
No. Domain name
Name of
Registered Proprietor Expiry date
1 . . . micot.cn Our company March 20, 2031
2 . . . micot.com Our company June 24, 2031
3 . . . micot.com.cn Our company May 21, 2031
4 . . . micot.net Our company January 14, 2032
Save as disclosed above, till the Latest Practicable Date, there was no other trade or
service mark, patent, intellectual or industrial property right which was material in
relation to our business.
FURTHER INFORMATION ABOUT OUR DIRECTORS AND SUBSTANTIAL
SHAREHOLDERS
Particulars of Directors’ Service Contracts
We have entered into a service contract or a letter of appointment with each of the
Directors in respect of, among others, (i) term of service, (ii) termination, (iii) compliance
with the relevant laws and regulations and (iv) observance of the Articles of Association.
The service contracts and letters of appointment may be renewed in accordance with the
Articles of Association and the applicable laws, rules and regulations from time to time.
Save as disclosed above, none of the Directors has or is proposed to have a service
contract with any member of our Group.
Remuneration of Directors
For details of the remuneration of our Directors, see “Directors and Senior
Management — Directors’ Remuneration and Remuneration of the Five Highest-paid
Individuals” and “Appendix I — Notes to the Historical Financial Information —
Directors’ and Chief Executive’s Remuneration”.
Disclosure of interests
Interests of the Directors and Chief Executive of our Company
Save as disclosed below, immediately following the completion of the Global
Offering (assuming the Over-allotment Option is not exercised and taking into amount the
Share Subdivision) and the conversion of the Unlisted Shares into H Shares, so far as the
Directors are aware, none of the Directors or chief executive of our Company will have any
interest and/or short position (as applicable) in the Shares, underlying Shares or
debentures of our Company or our associated corporation (within the meaning of Part XV
of the SFO) which will be required to be notified to our Company and the Stock Exchange
pursuant to Divisions 7 and 8 of Part XV of the SFO (including interests or short positions
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, 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, once the H Shares are listed on the Stock
Exchange.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-6 –


--- page 381 ---
Name Position Nature of interest
Number and
description of
Shares held
Approximate
percentage of
shareholding in
the relevant type
of Shares
(1)
Approximate
percentage of
shareholding in
the total share
capital of our
Company (1)
Dr. Wang Bing ..... Chairman of our Board,
Executive Director and
Chief Executive Officer
Beneficial owner 99,660,050 H Shares 35.58% 43.43%
Interest of spouse
(2) 44,400,000 Unlisted
Shares
85.93%
Interest in controlled
corporations (3)
Dr. Wang Mei . . . . . Non-executive Director Beneficial owner 99,660,050 H Shares 35.58% 43.43%
Interest of spouse (2) 44,400,000 Unlisted
Shares
85.93%
Interest in controlled
corporations (3)
1. The calculation is based on the completion of the Share Subdivision and the assumption that (i)
the Over-Allotment Option is not exercised, (ii) the 222,016,700 Unlisted Shares (taking into
account the Share Subdivision) will be converted into H Shares, and (iii) the total number of the
Shares in issue will be 331,740,350 H Shares immediately after completion of the Global Offering.
2. Immediately following the completion of the Global Offering, (assuming the Over-allotment
Option is not exercised and taking into account the Share Subdivision), Xi’an Zhongrui shall
directly hold 4.52% of the interest in our Company. Dr. Wang Mei has control over Xi’an Zhongrui
Zekang Enterprise Management Consulting Co., Ltd.* (ʮ̡)
(“Zhongrui Zekang”), and Zhongrui Zekang is the general partner of Xi’an Zhongrui.
Accordingly, Xi’an Zhongrui is controlled indirectly by Dr. Wang Mei. By virtue of the SFO, Dr.
Wang Mei is deemed to be interested in the Shares held by Xi’an Zhongrui.
3. Dr. Wang Bing and Dr. Wang Mei are spouses. Accordingly, Dr. Wang Bing and Dr. Wang Mei are
deemed to be interested in the Shares held by each other under the SFO.
Interests of Substantial shareholders
Save as disclosed in “Substantial Shareholders” in this prospectus, the Directors are
not aware of any other person (other than the Directors or chief executive of our
Company) who will, immediately following the completion of the Global Offering
(assuming no exercise of the Over-allotment Option) and the conversion of the Unlisted
Shares into H Shares, have an interest and/or short position 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 who is, directly or indirectly,
interested in 10% or more of the nominal value of any class of share capital carrying rights
to vote in all circumstances at general meetings of our Company or any other member of
our Group.
Pre-IPO Share Incentive Plan
Our Company adopted an employee incentive scheme (the “ Xi’an Zhongrui
Employee Incentive Scheme ”) on June 11, 2020 (and amended the same in August 2025)
with the primary purpose to improve corporate governance and to incentivize and reward
eligible persons who have contributed to the success of our Company. In establishing the
Xi’an Zhongrui Employee Incentive Scheme, our Company aims to fully mobilize the
enthusiasm of management and employees of our Company, further aligning interests of
Shareholders, our Company and its employees to jointly foster long-term development,
thereby allowing all parties to share the benefits derived from our Company’s growth. The
following is a summary of the principal terms of the Xi’an Zhongrui Employee Incentive
Scheme.
Principal Terms
Implementation structure and platform
Xi’an Zhongrui was established in the PRC as a limited partnership on July 18, 2019
to serve as our Company’s employee incentive platform, with Zhongrui Zekang (a limited
partnership established in the PRC, owned as to approximately 99.0% by Dr. Wang Mei)
being their General Partner. As of the Latest Practicable Date, Xi’an Zhongrui subscribed
for approximately 5.63% of the shareholding in our Company. For more details, please
refer to the paragraphs headed “History, Development and Corporate Structure —
Employee Incentive Scheme — Xi’an Zhongrui” in this prospectus.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-7 –


--- page 382 ---
Eligible participants and grants of awards
Under the Xi’an Zhongrui Employee Incentive Scheme, eligible participants are
determined by our Company’s chairperson, Dr. Wang Bing, and may hold positions as
Directors, supervisors, senior and middle management, key employees and external
consultants or expert advisors of our Company and our Group.
The participants of the Xi’an Zhongrui Employee Incentive Scheme will be granted
awards under the scheme, where they are given a right to obtain partnership interest in
Xi’an Zhongrui as limited partners, such that participants indirectly hold Shares in our
Company. Under the Xi’an Zhongrui Employee Incentive Scheme, participants will have
rights to cash dividends distributed by our Company from time to time (if any), but will
not have voting rights in and control over our Company and/or our Group.
Lock-up Period
The Xi’an Zhongrui Employee Incentive Scheme is subject to a strict lock-up period
from the date of the grant to 12 months after the Listing Date. During the strict lock-up
period, participants may not transfer, gift or otherwise dispose of their awards.
Notwithstanding the foregoing, subject to prior approval from Dr. Wang Bing,
participants may transfer, gift or otherwise dispose of their awards to Xi’an Zhongrui, Dr.
Wang Bing or their designated entities, or otherwise dispose of awards in the manner as
approved by Dr. Wang Bing.
Vesting of awards
Awards vest in the participants over a five-year period, in five equal 20% tranches
on each anniversary of the grant date, and are subject to the following conditions:
(1) The participant was and remains employed by our Company or our Group for
the relevant annual period; and
(2) The participant had achieved a minimum performance rating of “C” or above
in the appraisal for the previous year.
The amount of awards vested will also be affected by actual performance of
participants in the previous year. In particular, for participants that receive a performance
rating of:
– “A” or “B”: 100% of the annual 20% tranch will be vested in the participant;
– “C”: 80% of the annual 20% tranch will be vested in the participant, and the
remaining 20% of the annual 20% tranch will be forfeited;
– Below “C”: the entire annual 20% tranch does not vest in the participant and is
forfeited.
Disposal of awards and realizing gains
After the strict lock-up period expires and the awards are vested, participants may
dispose of their awards and realize gains by submitting sale requests to Dr. Wang Bing
during the submission window. Submission windows open quarterly, and should sale
requests be submitted, Xi’an Zhongrui will process the sales of corresponding Shares in
our Company so that net proceeds from such sale of Shares are distributed to the relevant
participant.
Repurchase of Shares by our Company upon termination
Our Company shall have the right to repurchase Shares should employment of any
participant terminate. The repurchase price for the relevant Shares will be determined by
the reason for termination of employment:
– Termination by misconduct: Company to repurchase all vested and unvested
Shares at cost;
– Termination by resignation (without fault): Company to repurchase all vested
Shares at cost plus 7% interest per annum (if length of employment is over two
years but under five years), cost plus 9% interest per annum (if length of
employment is over five years and during pre-IPO), and all unvested Shares at
cost.
– Termination by retirement or death (without fault): Company to repurchase
all unvested Shares at cost, and all vested Shares at cost plus 9% interest per
annum (if employment is terminated prior to Listing). Should such
termination occur after the Listing Date, the participant may retain the vested
Shares.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-8 –


--- page 383 ---
Details of the granted awards
As of the Latest Practicable Date, Xi’an Zhongrui held 300,000 Shares of our
Company. For details on the awards granted to Director(s), consultant(s) and employees
of our Company and our Group for the years ended December 31, 2024 and 2025, please
refer to Note 28 of the Accountants’ Report included in Appendix I of this prospectus. The
following table sets out the particulars of the partnership interest in Xi’an Zhongrui as of
the Latest Practicable Date:
No. Name
Type of
partnership
interest
Approximate
Partnership
interest (%)
1. Zhongrui Zekang General Partner 27.46
2. Nexarcana Limited (1) Limited Partner 29.99
3. Wang Shangling (ޛLimited Partner 6.92
4. Zou Ran (ཅ್) Limited Partner 6.92
5. Shao Wenji (ࢊLimited Partner 4.21
6. Niu Enguo (਷) Limited Partner 2.77
7. Wei Ruibin (ᕧ๿ⅳ) Limited Partner 2.11
8. Li Jiaolun (ࡐLimited Partner 2.00
9. Wang Pengfei (࠭Limited Partner 2.00
10. Yu Zhi (Яқ) Limited Partner 1.99
11. Liu Yongzhen (ޜLimited Partner 1.95
12. Liu Xingxin (ᄎጳอ) Limited Partner 1.50
13. Song Lanlan (҂ᚆᚆ) Limited Partner 1.31
14. Wang Ruiling (ޛLimited Partner 1.21
15. Fu Guoqin (˹਷ೞ) Limited Partner 1.14
16. Ren Pengliang (ڥ؃Limited Partner 0.81
17. Zhao Zhiyang Limited Partner 0.69
18. Wang Ying (ߵLimited Partner 0.69
19. Huang Zhian (τ) Limited Partner 0.42
20. Wang Linyuan (ˮ೙ధ) Limited Partner 0.38
21. Wen Jierong (๝ẘႂ) Limited Partner 0.32
22. Zheng Du (ቍே) Limited Partner 0.30
23. Sun Xin (ᢊ) Limited Partner 0.24
24. Qi Li (ᘆ) Limited Partner 0.22
25. Zhang Xiaofa (جLimited Partner 0.21
26. Zhang Haibo (تLimited Partner 0.20
27. Zhang Jianing (ྐྵ) Limited Partner 0.20
28. Wang Ying (ˮᆦ) Limited Partner 0.19
29. Zhang Shuyang ( ੵബජ) Limited Partner 0.14
30. Yu Hao (ɲख) Limited Partner 0.12
31. Zhang Yuanhui (ੵధሾ) Limited Partner 0.11
32. Li Bin (ҽႷ) Limited Partner 0.10
33. Ma Siying (ڎܠLimited Partner 0.10
34. Liu Ximei (ᄎГૠ) Limited Partner 0.10
35. Zhang Ying (ੵᆦ) Limited Partner 0.09
36. Zhu Yingying (ϡᆦᆦ) Limited Partner 0.09
37. Zhu Yu (ϡρ) Limited Partner 0.07
38. Mei Ying (ૠᆦ) Limited Partner 0.07
39. Yin Tingting (ʙణణ) Limited Partner 0.07
40. Fu Yu (˹ຄ) Limited Partner 0.07
41. Chong Jiali (၇Գ஁) Limited Partner 0.07
42. Yang Meng (เଛ) Limited Partner 0.07
43. Mi Yuan (Ϸʩ) Limited Partner 0.06
44. Zheng Lingling (ޛޛLimited Partner 0.06
45. Zhao Chenxi (Ⴛોᘙ) Limited Partner 0.06
46. Liu Lei (ᄎᆾ) Limited Partner 0.06
47. Ding Qian (ɕᙛ) Limited Partner 0.06
48. Wu Shifei (࠭Limited Partner 0.05
49. Pan Zhaoyang ( ᆙಃජ) Limited Partner 0.03
T otal 100.00
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-9 –


--- page 384 ---
Note:
(1) Nexarcana Limited is a company incorporated in Hong Kong in November 2024. It is wholly
owned by Dr. Yu Weiping, an Executive Director and Senior Vice President of the Company.
Agency Fees or Commissions Received
The Underwriters will receive an underwriting commission in connection with the
Underwriting Agreements. See “Underwriting — Underwriting Arrangements and
Expenses — Commissions and Expenses.” Save in connection with the Underwriting
Agreements, no commissions, discounts, brokerages or other special terms have been
granted by our Group to any person (including the Directors, promoters and experts
referred to in “— Other Information — Qualifications of Experts” below) in connection
with the issue or sale of any capital or security of our Company or any member of our
Group within the two years immediately preceding the date of this prospectus.
Within the two years immediately preceding the date of this prospectus, no
commission has been paid or is payable for subscription, agreeing to subscribe, procuring
subscription or agreeing to procure subscription for any share in or debentures of our
Company.
Disclaimers
(a) None of the Directors nor any of the experts referred to in “Qualifications of
Experts” below has any direct or indirect interest in the promotion of, or in
any assets which have been, within two years immediately preceding the date
of this prospectus, acquired or disposed of by, or leased to, any member of our
Group, or are proposed to be acquired or disposed of by, or leased to, any
member of our Group.
(b) Save in connection with the Underwriting Agreements, none of the Directors
nor any of the experts referred to “Qualifications of Experts” below is (i)
materially interested in any contract or arrangement subsisting at the date of
this prospectus which is interested legally or beneficially in any shares in any
member of our Group; or (ii) has any right (whether legally enforceable or not)
to subscribe for or to nominate persons to subscribe for any securities in any
member of our Group; and
(c) None of the Directors or their respective close associates or the Shareholders
who to the knowledge of the Directors are interested in more than 5% of our
issued share capital has any interest in our top five customers or suppliers
during the Track Record Period.
OTHER INFORMATION
Estate Duty and Other Indemnities
Estate Duty
The Directors have been advised that no material liability for estate duty is likely to
fall on our Company or any of our subsidiaries.
Other Indemnities
Our Controlling Shareholders, Dr. Wang Bing and Dr. Wang Mei, have entered into
the Deed of Indemnity with, and in favor of, our Company (for ourselves and as trustee
for each of our subsidiaries) to provide indemnities on a joint and several basis in respect
of, among other matters, any fines, penalties, claims, costs, expenses and losses (to the
extent that provision, reserve or allowance has not been made for such fines, penalties,
claims, costs, expenses or losses in the audited consolidated financial statements included
in the Accountants’ Report as set out in Appendix I to this prospectus) incurred by any
member of our Group after the Listing resulting from any non-compliance incidents of
any member of our Group with applicable laws and regulations on or before the Listing
Date.
The Deed of Indemnity shall become effective on the Listing Date and shall continue
in full force and effect until it is terminated.
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 the Directors are aware, no litigation, arbitration, administrative proceedings or
claims of material importance are pending or threatened against any member of our
Group.
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-10 –


--- page 385 ---
Joint Sponsors
Each of the Joint Sponsors satisfies the independence criteria applicable to sponsors
set out in Rule 3A.07 of the Listing Rules.
The Joint Sponsors will receive an aggregate fee of US$400,000 to act as the sponsors
to our Company in connection with the Listing.
Compliance Adviser
Our Company has appointed Halcyon Capital Limited as the compliance adviser
upon Listing in compliance with Rule 3A.19 of the Listing Rules.
Preliminary Expenses
As of the Latest Practicable Date, our company did not incur any material
preliminary expenses.
Promoters
Our Company converted into a joint stock company with limited liability on
January 17, 2025, and the promoters of our Company are our then 21 shareholders. 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 or the related transactions
described in this prospectus.
Qualification of Experts
The qualifications of the experts who have given opinions or advice in this
prospectus are as follows:
Name Qualification
CCB International
Capital Limited ..............
A licensed corporation under the SFO to
conduct type 1 (dealing in securities), type 4
(advising on securities) and type 6 (advising on
corporate finance) regulated activities as
defined under the SFO
China Merchants Securities
(HK) Co., Limited ...........
A licensed corporation to conduct type 1
(dealing in securities), type 2 (dealing in futures
contracts), type 4 (advising on securities), type
6 (advising on corporate finance) and type 9
(asset management) regulated activities as
defined under the SFO
JunHe LLP .................... P R C Legal Advisor
Tian Yuan Law Firm ............ P R CI n tellectual Property Legal Advisor
Deloitte Touche Tohmatsu ...... Certified Public Accountants and Registered
Public Interest Entity Auditor
Frost & Sullivan (Beijing) Inc.,
Shanghai Branch Co. .........
Independent Industry Consultant
Grandall Law Firm (Shenzhen). . Legal adviser to our Company as to PRC data
compliance laws
King and Wood LLP ............ U.S. Legal Advisor in relation to our business
operation in the U.S.
Concord & Sage PC ............ Legal adviser to our Company as to US data
compliance laws
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-11 –


--- page 386 ---
Consents of Experts
Each of the experts referred to in “Qualification of Experts” above has given and has
not withdrawn its written consent to the issue of this prospectus with the inclusion of its
reports, letters or opinions (as the case may be) and the references to its name included
herein in the form and context in which they are included.
T axation of Holders of H shares
The sale, purchase and transfer of H Shares are subject to Hong Kong stamp duty.
The current rate charged on each of the seller and purchaser is 0.1% of the consideration
or, if higher, the fair value of the H Shares being sold or transferred.
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 as far as applicable.
Miscellaneous
Save as otherwise disclosed in this prospectus:
(a) within the two years preceding the date of this prospectus, (i) our Company
has not issued nor agreed to issue any share or loan capital fully or partly paid
either for cash or for a consideration other than cash; and (ii) no commission,
discount, brokerage or other special term has been granted in connection with
the issue or sale of any shares of our Company;
(b) no Share or loan capital of our Company, if any, is under option or is agreed
conditionally or unconditionally to be put under option;
(c) our Company has not issued nor agreed to issue any founder shares,
management shares or deferred shares;
(d) our Company has no outstanding convertible debt securities or debentures;
(e) there is no arrangement under which future dividends are waived or agreed to
be waived;
(f) there has been no interruption in our business which may have or have had a
significant effect on the financial position in the last 12 months;
(g) our Company is not presently listed on any stock exchange or traded on any
trading system;
(h) our Company is a joint stock limited company and is subject to the PRC
Company Law. Neither our company nor any of its subsidiaries is listed in any
stock exchange; and
(i) the English text of this prospectus shall prevail over its respective Chinese
text.
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 (Exemption of Companies and Prospectuses from Compliance with
Provisions) Notice (Chapter 32L of the Laws of Hong Kong).
APPENDIX IV STATUTORY AND GENERAL INFORMATION
– IV-12 –


--- page 387 ---
DOCUMENTS DELIVERED TO THE REGISTRAR OF COMPANIES IN HONG KONG
The documents attached to the copy of this prospectus delivered to the Registrar of
Companies in Hong Kong for registration were:
(a) a copy of each of the material contracts referred to in the paragraph headed
“Appendix IV — Statutory and General Information — Further Information
about our Business — Summary of Our Material Contracts”; and
(b) the written consents referred to in “Appendix IV — Statutory and General
Information — Other information — Consents of Experts”.
DOCUMENTS A V AILABLE ON DISPLA Y
Copies of the following documents will be available on display on the websites of
the Stock Exchange at www.hkexnews.com and our website at www.micot.cn during a
period of 14 days from the date of this prospectus:
(a) Articles of Association;
(b) the Accountants’ Report prepared by Deloitte Touche Tohmatsu, the text of
which is set out in Appendix I to this prospectus;
(c) the audited consolidated financial statements of our Company for the years
ended December 31, 2024 and 2025;
(d) the report prepared by Deloitte Touche Tohmatsu on the unaudited pro forma
financial information of our Group, the text of which is set out in Appendix II
to this prospectus;
(e) The PRC legal opinion issued by JunHe LLP , our PRC legal advisor, on the
matters of, among other things, the general corporate matters of our Group;
(f) the written consents referred to in “Appendix IV — Statutory and General
Information — Other information — Consents of Experts”;
(g) the material contracts referred to in “Appendix IV — Statutory and General
Information — Further Information about our Business — Summary of Our
Material Contracts”;
(h) the service contracts and appointment letters referred to in “Appendix IV —
Statutory and General Information — Further Information about Our
Directors and Substantial Shareholders — Particulars of Directors’ Service
Contracts”;
(i) the industry report issued by Frost & Sullivan (Beijing) Inc., Shanghai Branch
Co., the summary of which is set forth in the section headed “Industry
Overview”;
(j) the PRC Company Law, the PRC Securities Law, the Trial Measures and
Guidelines for the Articles of Association of Listed Companies issued by the
CSRC, together with their unofficial English translations;
(k) the legal opinions from Tian Yuan Law Firm, the legal advisor to the Company
as to PRC intellectual property laws;
(l) the legal opinions from Grandall Law Firm (Shenzhen), the legal advisor to
the Company as to PRC data compliance laws;
(m) the legal opinions from King and Wood LLP , the legal advisor to the Company
as to U.S. laws in relation to the Company’s business operation in the U.S.;
(n) the legal opinions from Concord & Sage PC, the legal advisor to the Company
as to U.S. data compliance laws; and
(o) the terms of the Employee Incentive Scheme.
APPENDIX V DOCUMENTS DELIVERED TO THE REGISTRAR OF
COMPANIES AND A V AILABLE ON DISPLA Y
–V - 1–


--- page 388 ---
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