邁威生物（2493.HK）發佈2026年中期報告：收入同比增長209%至3.13億元人民幣，淨虧損收窄至5.24億元

邁威（上海）生物科技股份有限公司
Mabwell (Shanghai) Bioscience Co., Ltd.
(A joint stock company incorporated in the People’s Republic of China with limited liability)

Stock Code : 2493

2026
Interim Report

Contents
2

Corporate Information

4

Business Highlights

6

Financial Highlights

7

Management Discussion & Analysis

40

Corporate Governance and Other Information

51

Independent Review Report

52

Interim Condensed Consolidated Statement
of Profit or Loss and Other Comprehensive
Income

53

Interim Condensed Consolidated Statements
of Financial Position

55

Interim Condensed Consolidated Statement
of Changes in Equity

57

Interim Condensed Consolidated Statements
of Cash Flows

59

Notes to Interim Condensed Consolidated
Financial Information

72

Forward-Looking Statements

73

Definitions

77

Glossary

2

Corporate Information

BOARD OF DIRECTORS

JOINT COMPANY SECRETARIES

Executive Directors

Ms. WANG Hefei
Ms. LEUNG Kwan Wai

Mr. TANG Chunshan (唐春山)
Dr. LIU Datao (Chairman ) (劉大濤)
Dr. WU Hai (武海)
Mr. HUA Jun (華俊)
Dr. GUI Xun (桂勛)

Independent Non-executive Directors
Mr. QIN Zhengyu (秦正余)
Mr. ZHOU Rui (周睿)
Ms. LI Fan (李凡)
Ms. WANG Fang (王芳)

REGISTERED OFFICE, HEADQUARTER
AND PRINCIPAL PLACE OF BUSINESS IN
THE PRC
Room 105, Block 2
No. 230 Cailun Road
China (Shanghai) Pilot Free Trade Zone
Shanghai, China
Email for H Shares: irhk@mabwell.com
Email for A shares: ir@mabwell.com

PRINCIPAL PLACE OF BUSINESS IN
HONG KONG

AUTHORIZED REPRESENTATIVES
Mr. HUA Jun
Ms. LEUNG Kwan Wai

AUDIT COMMITTEE
Mr. QIN Zhengyu (Chairperson)
Mr. ZHOU Rui
Ms. LI Fan

REMUNERATION AND APPRAISAL
COMMITTEE
Dr. LIU Datao
Ms. LI Fan (Chairperson)
Mr. ZHOU Rui

NOMINATION COMMITTEE
Dr. LIU Datao
Mr. ZHOU Rui (Chairperson)
Ms. LI Fan

STRATEGY COMMITTEE

Room 1928, 19/F, Lee Garden One
33 Hysan Avenue
Causeway Bay, Hong Kong

Mr. TANG Chunshan
Dr. LIU Datao (Chairperson)
Dr. WU Hai

LEGAL ADVISERS TO HONG KONG LAW

ESG COMMITTEE

Davis Polk & Wardwell
10/F, The Hong Kong Club Building
3A Chater Road
Central
Hong Kong

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

Dr. LIU Datao (Chairperson)
Mr. HUA Jun
Ms. LI Fan

3
Corporate Information

H SHARE REGISTRAR

COMPANY WEBSITE

Tricor Investor Services Limited
17/F, Far East Finance Centre
16 Harcourt Road
Hong Kong

http://www.mabwell.com

STOCK CODE
H-Share Stock Exchange: 2493
A-Share Stock Exchange: 688062

AUDITOR
Ernst & Young
Certified Public Accountants
Registered Public Interest Entity Auditor under the
Accounting and Financial Reporting Council Ordinance
27/F, One Taikoo Place
979 King’s Road, Quarry Bay
Hong Kong

COMPLIANCE ADVISER
Somerley Capital Limited
20/F, China Building
29 Queen’s Road Central
Hong Kong

PRINCIPAL BANKER
Shanghai Pudong Development Bank
(Shanghai Hongqiao Branch)
1st Floor, Maxdo Shopping Mall
8 Xingyi Road
Changning District, Shanghai, China

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

4

Business Highlights

As of the Latest Practicable Date, starting with biosimilars that target well-established receptors with high
market demand, and innovative drugs that address significant unmet clinical needs, we have established a
complete industrial chain covering preclinical research, commercial manufacturing and sales. We have attained
the following achievements and milestones:
•

The Company has consistently regarded innovative R&D as its core development strategy, and
established a full-cycle innovation system commencing with target validation and molecular discovery for
antibody drugs. The Company boasts three distinctive technology platforms, namely the antibody-drug
conjugate (“ADC”) drug development platform, integrated high-efficiency antibody discovery platform
and TCE bi/tri-specific antibody development platform. The Company has 15 key product candidates at
the clinical or marketing stage, comprising 11 innovative drugs and 4 biosimilars, focusing on oncology
and age-related diseases covering immunology, ophthalmology, orthopedics and other therapeutic
areas. Among them, four products are at the marketing stage; one product is under review for the
application for marketing authorization for domestically manufactured drugs in the PRC; two products
are in pivotal Phase III registration clinical trials; and the remaining products are at various other clinical
study stages. 9MW2821, one of our core products, has entered pivotal clinical stages and has received
multiple Breakthrough Therapy Designations (“BTD”). Currently, four Phase III pivotal registration clinical
trials are underway. Among these, the Phase III clinical trials for monotherapy and combination therapy
in urothelial carcinoma (“UC”), as well as monotherapy in cervical cancer (“CC”), are planned for interim
analysis in 2026, with a pre-NDA (New Drug Application) meeting anticipated to be requested based
on the results of these analyzes. In addition, the Phase III clinical trial for triple-negative breast cancer
(“TNBC”) (monotherapy in patients previously treated with a topoisomerase I inhibitor-based ADCs) and
the U.S. Phase Ib clinical trial are also being actively advanced.
–

In January 2026, the first patient was dosed in the clinical trial of 7MW4911 for indications of
advanced colorectal cancer and other advanced gastrointestinal tumors in the United States.

–

In February 2026, 9MW2821 completed enrollment of all subjects in the Phase III clinical study for
the treatment of recurrent or metastatic CC following failure of platinum-based chemotherapy.

–

7MW3711 completed enrollment of the first subject in the Ib/Phase II clinical trial evaluating the
combination of 7MW3711 and JS207 (PD-1/VEGF bispecific antibody) with or without platinumbased chemotherapy (cisplatin or carboplatin) in advanced solid tumors.

–

In March 2026, 9MW3011 completed enrollment of all subjects in a multicenter, randomized,
open-label, multiple-dose escalation Phase Ib clinical study evaluating the safety, tolerability,
pharmacokinetics, pharmacodynamics, and immunogenicity in Chinese patients with polycythemia
vera.

–

9MW0311 completed enrollment of the first subject for the study entitled “Interventional Effects
of Denosumab in Patients at High Risk of Osteoporotic Fractures with Type 2 Diabetes Mellitus
(CODE-DO Study)”.

–

In April 2026, 1MW5011 completed enrollment of all subjects in the multicentre, randomized,
active-controlled and placebo-parallel controlled Ib phase clinical study to evaluate the safety,
tolerability, pharmacokinetic and pharmacodynamic profiles of multiple doses of investigational
product 1MW5011 (former code: RP901) tablets in patients with knee osteoarthritis.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

5
Business Highlights

•

–

In May 2026, 9MW2821 has completed enrollment of all subjects in its Phase III clinical study
for locally advanced or metastatic UC in patients previously treated with platinum-based
chemotherapy and PD-(L)1 inhibitors, and has completed enrollment of the first patient in its Phase
III clinical study for locally advanced or metastatic TNBC.

–

The Investigational New Drug (“IND”) application for 9MW5211 in patients with inflammatory bowel
disease has received FDA clearance.

–

The supplemental application for 9MW0321 for the treatment of patients with bone metastases
from solid tumors and patients with multiple myeloma, to delay or reduce the risk of
skeletal-related events (pathologic fracture, spinal cord compression, bone radiotherapy, and bone
surgery), has been approved.

–

In June 2026, the IND applications for 9MW5211 in inflammatory bowel disease and multiple
sclerosis were approved by the National Medical Products Administration (“NMPA”), respectively.

–

The IND applications for 6MW5311 in hematologic malignancies (acute myeloid leukemia, chronic
myelomonocytic leukemia, and multiple myeloma) received FDA clearance and subsequent NMPA
approval.

–

9MW1911 for the efficacy and safety in patients with chronic obstructive pulmonary disease
completed enrollment of all subjects in a multicenter, randomized, double-blind, placebocontrolled Phase II clinical study.

–

In July 2026, the IND applications for 9MW5211 in type 1 diabetes mellitus, vitiligo, and primary
biliary cholangitis were successively approved by the NMPA.

–

Junmaikang (adalimumab injection) has been included in the new edition of the National Essential
Medicines List (2026 edition).

ABOUT OPERATIONS OF THE COMPANY
–

In April 2026, the Company completed the placing of new H Shares under general mandate,
pursuant to which an aggregate of 47,130,200 H Shares were successfully allotted and issued
at HKD27.64 per H Share. The net proceeds (after deduction of commissions and estimated
expenses) amounted to approximately HKD1,197.1 million, which will be used for innovative drug
development and general corporate purposes such as replenishment of working capital.

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

6

Financial Highlights

OPERATING RESULTS
For the six months ended
June 30,

Revenue
Loss for the period
Loss per share – Basic and diluted (RMB)

2026
RMB’000
(unaudited)

2025
RMB’000
(unaudited)

312,453
(524,204)
(1.26)

101,098
(552,232)
(1.38)

At June 30,

At December 31,

2026
RMB’000
(unaudited)

2025
RMB’000
(audited)

2,418,750
2,876,234
5,294,984
1,937,182
2,303,319
4,240,501
1,054,483

2,517,239
2,038,602
4,555,841
1,764,235
2,258,604
4,022,839
533,002

FINANCIAL POSITION

Non-current assets
Current assets
Total assets
Non-current liabilities
Current liabilities
Total liabilities
Total equity

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

7

Management Discussion & Analysis

I.

OVERVIEW
Founded in 2017, we are a pharmaceutical company in China recognized for our ability to innovate in
drug development and for our end-to-end capabilities from drug discovery to commercial sales. The
A Shares of our Company have been listed on the Shanghai Stock Exchange STAR Market (stock code:
688062) since January 2022 and the H Shares were listed on the Main Board of The Stock Exchange of
Hong Kong Limited (the “Hong Kong Stock Exchange” or the “Stock Exchange”) (stock code: 2493)
since April 2026. The Company has 15 key varieties in the clinical research or marketing stages, including
11 innovative drugs and 4 biosimilars, focusing on tumors and age-related diseases, such as immunology,
ophthalmology, orthopedics and other fields. Among them, 4 varieties have been marketed, 1 variety is
in the review stage of domestically produced drug registration and marketing authorization applications,
2 varieties are in the pivotal Phase III registration clinical stage, and other varieties are in different clinical
study stages.
As of the Latest Practicable Date, 9MW2821 was the most advanced among all Nectin-4 targeting ADCs
for UC developed in China in terms of clinical development stage and only second to Padcev. 9MW2821
was also the first Nectin-4 targeting ADC globally to enter a pivotal Phase III trial for CC. The Company
is currently conducting multiple clinical trials of 9MW2821 across UC, CC, TNBC, and esophageal cancer
(“EC”), including (i) Phase III trials as monotherapy and in combination with toripalimab for UC; (ii) a Phase
III trial as monotherapy for CC; (iii) a Phase III trial as monotherapy for TNBC; and (iv) multiple other Phase
I/II trials that are being rapidly advanced.

II.

BUSINESS REVIEW
Our Products and Product Pipeline
We mainly focused on developing drugs internally for oncology and age-related diseases, in areas such
as immunology, ophthalmology and orthopedics, which pose significant health risks globally with unmet
clinical needs. Our pipeline portfolio consists of innovative drug candidates (including ADCs and other
modalities) and commercialized drugs.

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

8
Management Discussion & Analysis

The following chart summarizes the development status of our pipeline products as of the Latest
Practicable Date.
Product

Target/Active
Pharmaceutical
ingredients

Internal/
External

Clinical
trial
location

Indications

Nectin-4
ADC

Self-developed

Oncology

7MW3711

B7-H3
ADC

Self-developed

6MW5311

CDH17
ADC

Self-developed

LILRB4/CD3

Self-developed

Phase 2

Phase 3

NDA

Market
Approval

“IND/NDA”
Application/Approval
Number

Current status/Next milestone

China

NMPA

BTD

2021LP01688

UC combination
with toripalimab (1L)

China

NMPA

BTD

2023LP00633

Phase III trial stage;
BTD granted by NMPA in January 2025;
Expect to conduct interim analysis and
submit pre-NDA in H2 2026

UC perioperative combination
with toripalimab

China

NMPA

2024LP02554

Phase II trial stage;
IND approved in November 2024

China

NMPA

2024LP01576

Phase III trial stage

United
States

FDA

IND 161043

Phase Ib trial stage (bridging study for dose optimization);
IND approved in March 2025;
FTD granted by FDA in July 2024

China

NMPA

TNBC combination
with toripalimab (1L)

CC monotherapy (2/3L)

China

NMPA

gynecological cancers
(including CC) combination with
other anti-tumor treatments (1L)

China

NMPA

EC monotherapy(2L+)

China

NMPA

Advanced solid tumor
(including EC) combination
with other anti-tumor treatments (1L)

China

NMPA

UC monotherapy or in combination
with toripalimab (1L)

China

NMPA

Lung cancer monotherapy (2L+)

China

NMPA

Advanced solid tumor combination with
toripalimab, with or without
other chemotherapy drugs

China

Advanced solid tumor combination with JS207,
with or without antitumor chemotherapy

China

FTD

FTD

FTD

ODD

2024LP01576

Phase II trial stage;

2021LP01688

Phase III trial stage;
FTD granted by FDA in May 2024;
Expect to conduct interim analysis
and submit pre-NDA in H2 2026

2024LP02507

Phase Ib/II trial stage;
IND approved in November 2024;

2021LP01688

Phase II trial stage;
FTD granted by FDA in February 2024;
ODD granted by FDA in August 2024

2024LP02507

Phase Ib/II trial stage;
IND approved in November 2024;

2021LP01688

Phase II trial stage

2023LP01409

Phase I/II trial stage;
ODD granted by FDA in July 2024;
Expect to finish Phase I/II trial in H1 2027

NMPA

2025LP00966

IND approved in April 2025

NMPA

2025LP03595

Phase Ib/II trial stage

ODD

China

NMPA

2023LP01409

Phase I/II trial stage;
Expect to finish Phase I/II trial in H2 2027

United
States

FDA

IND 169107

IND approved in February 2024

Advanced solid tumor

China

NMPA

2025LP02657

Phase I/II trial stage

Advanced Colorectal Cancer and Other Advanced
Gastrointestinal Tumors

United
States

FDA

IND 176738

Phase I/II trial stage

AML, CMML and MM

Rights

Global

Global

China

NMPA

2026LP01868

IND approved in June 2026

United
States

FDA

IND180976

IND approved in June 2026

Global

HSA-mhG-CSF/
fusion protein

Self-developed

Febrile neutropenia

China

NMPA

2025S01495

Approved for marketing in May 2025

Ex-Greater
China

Maiweijian
(迈卫健®)

RANKL/
denosumab
biosimilar

Self-developed;
Licensed-out

Giant cell tumor of bone, Solid tumor bone
metastases
and multiple myeloma

China

NMPA

2024S00481
2016L08301

Approved for marketing in March 2024

Global

COPD

China,
United States

Global

9MW3811

ST2/monoclonal
antibody

IL-11/
monoclonal
antibody

Self-developed

Idiopathic pulmonary fibrosis
Self-developed

Immunology

9MW5211

Undisclosed

NMPA, FDA

2021LP00644

Phase II trial stage;
Expect to initiate Phase III trial by the end of 2026

China

NMPA

2023LP00957

Finished Phase I trial in May 2024

Australia

TGA

CT-2022-CTN-04821-1

Finished Phase I trial in December 2023

United
States

FDA

IND 165283

IND approved in June 2023

Multiple
collaboration
companies

Greater
China

Hypertrophic scars and keloids

China

NMPA

2025LP02967

Phase II trial stage

IBD, MS, T1DM, vitiligo, and PBC

China

NMPA

2026LP01718
2026LP01776
2026LP02009
2026LP02151
2026LP02330

Phase I trial stage

Inflammatory bowel disease

United States

FDA

IND 180525

IND approved in May 2026

8 indications (RA, AS, Ps, etc.)

China

NMPA

2022S00142

Approved for marketing in March 2022

Global

Self-developed

Global

Junmaikang
(君迈康®)

TNF-α/
adalimumab
biosimilar

1MW5011
(RP901)

Undisclosed

License-in

Osteoarthritis

China

NMPA

2021LP00131

Phase II trial stage;
Expect to finish Phase II trial in 2028

Greater
China

Mailishu
(迈利舒®)

RANKL/
denosumab
biosimilar

Self-developed;
Licensed-out

The treatment of osteoporosis in
postmenopausal women at high risk
of fracture

China

NMPA

2024S00481

Approved for marketing in March 2023

Global

9MW0211

VEGF/
monoclonal
antibody

Self-developed

nAMD

China

NMPA

2020B02434

Finished Phase II/III trial stage

China

9MW0813

VEGF-Trap/
aflibercept
biosimilar

Self-developed;
Licensed-out

DME, nAMD

China

NMPA

CXSS2500098

Under NDA review

Global

TMPRSS6/
monoclonal
antibody

Self-developed;
Licensed-out

Polycythemia vera

China

NMPA

2023LP00017

9MW3011

Phase Ib trial stage;
Expect to finish Phase Ib trial in H2 2027

Iron overload disorders
including β-thalassemia

China

NMPA

2023LP00016

Phase Ib trial stage

Undisclosed
(Dual-target)

Self-developed;
Licensed-out

-

Pre-clinical

Co-developed;
Licensed-out

Partners

Global

Mailisheng
(迈粒生®)

9MW1911

Orthopedics

Phase 1

UC monotherapy (2L+)

Advanced solid tumor

7MW4911

IND

Phase III trial stage;
BTD granted by NMPA in August 2024;
Expect to conduct interim analysis and
submit pre-NDA in H2 2026

TNBC monotherapy
(resistance to TOPi-based ADC)

9MW2821

PreClinical

Multiple
collaboration
companies

Multiple
collaboration
companies

Ophthalmology

Hematology

Cardiovascular
Diseases

BTD

4MW5411
(2MW7141)

NMPA Breakthrough Therapy Designation

FTD

Lipid regulation for subjects with dyslipidaemia
and prevention of high-risk cardiovascular events
FDA Fast Track Designation

ODD

FTD

China

FDA Orphan Drug Designation

ODD

Multiple
collaboration
companies

Greater
China,
Southeast
Asia

1GRK^U     

The clinical trial is exempt

Abbreviations: ADC: antibody-drug conjugate; AS: ankylosing spondylitis; B7-H3: B7 Homolog 3; CC: cervical cancer; CD3: cluster of
differentiation 3; CDH17: Cadherin-17; COPD: chronic obstructive pulmonary disease; DME: diabetic macular edema; EC: esophageal
cancer; mhG-CSF: mutated human granulocyte colony-stimulating factor; HSA: human serum albumin; IL-11: interleukin 11; nAMD:
neovascular (wet) age-related macular degeneration; Ps: psoriasis; RA: Rheumatoid arthritis; RANKL: receptor activator of nuclear factor
kappa-B ligand; SCLC: small-cell lung carcinoma; ST2: suppressor of tumorigenicity 2; TCE: T-cell engagers; TMPRSS6: transmembrane
protease serine 6; TNBC: triple-negative breast cancer; TNF-α: tumor necrosis factor α; TOPi: topoisomerase inhibitors; UC: urothelial
cancer; VEGF: vascular endothelial growth factor

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

9
Management Discussion & Analysis

ADC Products
Core Product 9MW2821: A Nectin-4 Targeting ADC for the Treatment of Cancer
9MW2821 (generic name: Bulumtatug Fuvedotin, BFv) is a new Nectin-4 targeting ADC developed using
our proprietary ADC platform and integrated high-efficiency antibody discovery platform. The Company is
currently conducting multiple clinical studies across indications including UC, CC, EC, and breast cancer,
with over 2,200 subjects enrolled to date. The study results have demonstrated promising antitumor
activity and a favorable safety profile. We are conducting multiple Phase III clinical trials of 9MW2821
in China, including as monotherapy for unresectable locally advanced or metastatic UC, in combination
with toripalimab for unresectable locally advanced or metastatic UC, as a monotherapy for advanced or
metastatic CC, and as a monotherapy for TNBC resistant to topoisomerase I inhibitor-based ADCs. We are
also conducting a Phase Ib study of 9MW2821 as monotherapy for TNBC in the U.S..
Urothelial Carcinoma. We are conducting a Phase III clinical trial of 9MW2821 for the treatment of
locally advanced or metastatic inoperable UC as a second or later line therapy in China and plan to
conduct the interim analysis in the second half of 2026, and expect to request a pre-NDA meeting with
the NMPA based on the interim results. We are also conducting a Phase III clinical trial of 9MW2821 in
combination with toripalimab in first-line unresectable locally advanced or metastatic UC and plan to
conduct the interim analysis in the second half of 2026, followed by a pre-NDA meeting with the NMPA.
Concurrently with this trial, we initiated a Phase II factorial study to compare efficacy of 9MW2821 as a
monotherapy and as a combination therapy with toripalimab to support its NDA registration in 2024. In
addition, we intend to explore the efficacy of 9MW2821 as a combination therapy with toripalimab in UC
in the perioperative period. We obtained the IND approval for this trial from NMPA in November 2024,
and we initiated a Phase II clinical trial of 9MW2821 as a combination therapy with toripalimab in the
perioperative period for UC in China in June 2025, which is currently in the enrollment phase.
Cervical Cancer. 9MW2821 is the first Nectin-4-targeting ADC globally to report clinical data in CC,
and the first to enter Phase III pivotal clinical development for this indication. We are conducting a
Phase III clinical trial of 9MW2821 as a monotherapy for the treatment of recurrent or metastatic CC
who have failed platinum-based double-drug chemotherapy as a second or third line treatment. We
expect to conduct an interim analysis in the second half of 2026, followed by a pre-NDA meeting with
the NMPA based on the interim analysis results. In addition, we initiated a Phase Ib/II clinical trial that
investigates 9MW2821 as a combination therapy with other anti-tumor treatments in patients with
advanced gynecological malignancy including CC in China in April 2025. The clinical trial is currently in
the enrollment phase, and a Phase III clinical trial of the combination therapy is planned to be initiated
subsequently.

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

10
Management Discussion & Analysis

Triple-negative Breast Cancer. We are currently conducting a Phase II clinical trial to evaluate the
efficacy and safety of 9MW2821 as monotherapy in TNBC patients with resistance to topoisomerase I
inhibitor-based ADCs or in combination with toripalimab in patients with locally advanced or metastatic
TNBC in China. We have initiated 9MW2821 to a Phase III clinical trial as a second or later line
monotherapy for the treatment of advanced TNBC in patients with resistance to topoisomerase inhibitorsbased ADC in China, which is currently in the enrollment phase. In the U.S., the FDA issued a clinical
trial implied approval letter in July 2022 based on our IND application for Nectin-4-positive metastatic
solid tumors and we submitted to the FDA the protocol amendment for 9MW2821 monotherapy for the
treatment of TNBC in patients with resistance to topoisomerase I inhibitor-based ADCs in December 2024.
The FDA approved the protocol amendment for 9MW2821 on March 12, 2025. We initiated a Phase Ib
study for 9MW2821 as monotherapy in TNBC patients with resistance to topoisomerase I inhibitor-based
ADCs in the U.S. in August 2025, which is currently in the enrollment phase.
Esophageal Cancer. We will continue to explore 9MW2821 as a combination therapy with other antitumor treatments for the first-line treatment of EC, and we have initiated a Phase Ib/II clinical trial in June
2025 in China. The clinical trial is currently in the enrollment phase, and a Phase III clinical trial of the
combination therapy is planned to be initiated subsequently.
9MW2821 has received multiple regulatory designations. The FDA granted three Fast Track Designations
(“FTD”) for 9MW2821 for the treatment of (i) advanced, recurrent, or metastatic esophageal squamous
cell carcinoma, a type of EC, (ii) recurrent or metastatic CC progressed on or following prior treatment
with a drug containing platinum to treat cancer and (iii) locally advanced or metastatic Nectin-4 positive
TNBC in February 2024, May 2024, and July 2024, respectively. Additionally, the FDA granted Orphan Drug
Designation (“ODD”) for the treatment of EC on April 30, 2024. Furthermore, the NMPA granted BTD for
the treatment of locally advanced or metastatic UC that has failed previous platinum-based chemotherapy
and PD-(L)1 inhibitor therapy on August 9, 2024. Also, on January 8, 2025, the NMPA granted BTD to
9MW2821 in combination with toripalimab, an anti-PD-1 monoclonal antibody, for treatment-naïve,
unresectable, locally advanced or metastatic UC.
In the first half of 2026, the results of 9MW2821 studies were presented at multiple international
conferences and in academic publications:
1)

In April 2026, a clinical case report on CC from the team led by Professor Wang Shanbing at
the Cancer Center of Yibin Second People’s Hospital was published in The New England Journal
of Medicine (NEJM, impact factor: 78.5), titled Hepatic Pseudoprogression after Treatment with
Nectin-4-Targeted Antibody-Drug Conjugate;

2)

At the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting, updated results
from the Phase Ib/II study of 9MW2821 in combination with toripalimab for the treatment of locally
advanced or metastatic UC (la/mUC) were presented as an oral presentation (Abstract No. 4518;
Title: “Bulumtatug fuvedotin (BFv; 9MW2821) plus toripalimab in patients with locally advanced or
metastatic urothelial carcinoma (la/mUC): Follow-up results from a phase 1b/2 study). Additionally,
results from the Phase II study of 9MW2821 in combination with toripalimab in the perioperative
setting for muscle-invasive bladder cancer (“MIBC”) were presented as a poster (Abstract No.
4609; Title: “Bulumtatug fuvedotin (BFv; 9MW2821) plus toripalimab in perioperative patients with
muscle-invasive bladder cancer (MIBC): Results of cohort A from a phase 2 study”);

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

11
Management Discussion & Analysis

3)

At the European Society for Medical Oncology (“ESMO”) Gynae 2026, clinical study results of
9MW2821 in recurrent or metastatic CC were presented as an oral presentation (Abstract No.
28RO; Title: Bulumtatug fuvedotin (BFv, 9MW2821), a Nectin-4 antibody-drug conjugate, in patients
with recurrent or metastatic CC: Updated results from a phase I/II study). Additionally, results
from the Phase Ib/II clinical study of 9MW2821 in combination with toripalimab in recurrent
or metastatic CC were presented as a poster (Abstract No. 36P; Title: “Preliminary results of
bulumtatug fuvedotin (BFv, 9MW2821) in combination with toripalimab in patients with recurrent or
metastatic CC: A cohort from a phase Ib/II clinical study”);

4)

At the 2026 ESMO Annual Congress, study results from the Phase II clinical trial of 9MW2821 in
locally advanced or metastatic TNBC previously treated with topoisomerase I inhibitor-based
ADCs will be presented as an oral presentation (Abstract No. 4640RO; Title: Bulumtatug Fuvedotin
(BFv, 9MW2821), a Nectin-4-Targeting ADC, in Patients with Locally Advanced or Metastatic Triple
Negative Breast Cancer (la/mTNBC) Previously Treated with Topoisomerase I Inhibitor (TopI)-Based
ADCs: Results from a Phase II Clinical Trial Study).

WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET 9MW2821 SUCCESSFULLY.

Other ADC Products
7MW3711: A B7-H3-targeting ADC for Treatment of Cancer
7MW3711 is an ADC that specifically targets B7-H3, an immune checkpoint protein, for the treatment
of advanced solid tumors. In preclinical safety studies in cynomolgus monkeys, 7MW3711 showed good
tolerance and pharmacokinetic properties. Preliminary non-human primate toxicology studies indicate
its targeted toxicity and off-target toxicity are effectively controlled, with no significant gastrointestinal
or hematological toxicity observed, demonstrating good safety and tolerability. We initiated two Phase
I/II clinical trials to evaluate the safety and efficacy of 7MW3711 as monotherapy for the treatment of
advanced solid tumors in China in August 2023 and September 2023, respectively. Both studies are
planned for completion in 2027. In addition, the FDA granted ODD for the treatment of small cell lung
cancer in July 2024. In April 2025, the NMPA approved our IND application for a Phase Ib/II combination
therapy clinical trial of 7MW3711 in combination with toripalimab, with or without other chemotherapy
drugs, in subjects with advanced solid tumors. In February 2026, the first patient was enrolled in the
Phase Ib/II clinical trial of 7MW3711 in combination with JS207 or JS207 and anti-tumor therapeutics in
patients with advanced solid tumors.
The Company has completed communication and discussions with the Center for Drug Evaluation of the
NMPA regarding a pivotal Phase III clinical trial in squamous cell lung cancer, with plans to initiate the
trial in the second half of 2026. To date, no B7-H3 ADC has globally entered a Phase III clinical stage in
squamous cell lung cancer. Concurrently, the Company also actively participated in the 2025 ASCO and
ESMO congresses, reporting partial clinical data from the Phase I/II studies in patients with advanced
solid tumors in poster presentations.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET 7MW3711 SUCCESSFULLY.

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12
Management Discussion & Analysis

7MW4911: A CDH17-targeting ADC for Treatment of Cancer
7MW4911 is an ADC that specifically targets CDH17, a cell adhesion protein and a promising target for
cancer therapy. 7MW4911 integrates a novel unconjugated antibody (Mab0727), an innovative linker,
and the proprietary MF-6 payload, a potent DNA topoisomerase I inhibitor designed to overcome
common resistance mechanisms in cancer cells. The antibody demonstrates high specificity for CDH17,
rapid internalization capabilities, and cross-reactivity with both human and monkey CDH17 antigens at
moderate affinity. The MF-6 payload further enhances 7MW4911’s efficacy by providing robust plasma
stability, controlled drug release, and potent bystander effects on surrounding tumor cells.
In July 2025, preclinical study findings were published in Cell Reports Medicine (title: Overcoming
multidrug resistance in gastrointestinal cancers with a CDH17-targeted ADC conjugated to a DNA
topoisomerase inhibitor), which systematically demonstrated that 7MW4911 achieves tumor-selective
cytotoxic payload release through CDH17-mediated efficient internalization. Its core advantages are
reflected in five key dimensions. In terms of molecular design, homogeneous drug loading (DAR=4, with
a ratio >95%) and a stable linker confer excellent plasma stability, while the highly membrane-permeable
MF-6 toxin produces potent bystander killing effects. In terms of antitumor activity, 7MW4911 showed
profound tumor inhibition in colorectal, gastric, and pancreatic cancer PDX/CDX models, and was
effective across multiple mutations including RAS/BRAF and across different CMS subtypes of colorectal
cancer. In terms of resistance breakthrough, it demonstrated significantly superior efficacy over MMAEor DXd-class ADCs in ABC transporter-mediated multidrug-resistant models, and was able to reverse
tumor progression following treatment with such ADCs. In terms of target universality, it retained
significant activity even against tumors with moderate to low CDH17 expression. In terms of safety,
mouse studies showed limited tissue distribution, and cynomolgus monkey toxicology studies revealed
a manageable metabolic profile (moderate half-life, no accumulation tendency) and a wide therapeutic
window, with no significant toxicity signals observed. Based on these properties, 7MW4911 demonstrates
the potential to become a transformative therapy for advanced gastrointestinal solid tumors.
The Company has independent intellectual property rights over the molecular structure of 7MW4911
and has filed relevant patent applications. In July 2025, the Company simultaneously submitted
IND applications to the NMPA and the FDA for the treatment of advanced solid tumors, particularly
gastrointestinal cancers including colorectal, gastric, and pancreatic cancers. In August 2025, the
IND application for 7MW4911 received FDA clearance to conduct a Phase I/II study evaluating safety,
pharmacokinetics, and efficacy in advanced colorectal cancer and other advanced gastrointestinal
tumors. In October 2025, the IND application received NMPA clearance to conduct a Phase I/II clinical
study in patients with advanced solid tumors to evaluate safety, tolerability, pharmacokinetic profile, and
preliminary efficacy. In November 2025, the first patient was dosed in the Chinese Phase I/II clinical trial
of 7MW4911. In January 2026, the first patient was dosed in the U.S. clinical trial of 7MW4911 in patients
with advanced colorectal cancer and other advanced gastrointestinal tumors.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET 7MW4911 SUCCESSFULLY.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

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Management Discussion & Analysis

Non-ADC Products
Oncology
Mailisheng (邁粒生 ®): a Human Serum Albumin-human G-CSF Fusion Protein for Treatment of
Cancer
Mailisheng is a self-developed recombinant fusion protein composed of human albumin and human
G-CSF. G-CSF is a key factor that promotes the production and release of neutrophils from bone marrow
into the periphery, regulating their early development, survival, migration, and activation by binding to
its receptor. Recombinant human G-CSF has a relatively short half-life in the human body. To address
this, Mailisheng uses human serum albumin fusion technology to extend the half-life. This allows slow
release of the G-CSF component of Mailisheng, continuing to promote the development and release of
neutrophils over an extended period.
In May 2025, the NMPA granted marketing approval of Mailisheng, representing our first commercialized
innovative drug. It is globally the first launched G-CSF developed with albumin long-acting fusion
technology. The clinical trials have demonstrated good safety, tolerability, and efficacy profiles of
Mailisheng. Mailisheng is approved to be used in adult patients with non-myeloid malignancies to reduce
the incidence of infections manifested by febrile neutropenia when receiving myelosuppressive anticancer
drugs associated with a clinically significant incidence of febrile neutropenia. Mailisheng is not suitable
for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
In June 2025, we and Taikang Biopharmaceutical (泰康生物醫藥), one of our wholly-owned subsidiaries,
entered into an agreement with Qilu Pharmaceutical Co., Ltd. (“Qilu”) to grant Qilu the exclusive rights to
develop, manufacture, improve, utilize, and commercialize Mailisheng in Greater China (including Chinese
Mainland, Hong Kong, Macau and Taiwan). In December 2025, Mailisheng commenced commercial
sales and was successfully added to the National Reimbursement Drug List for Basic Medical Insurance,
Work-Related Injury Insurance, and Maternity Insurance (2025 Edition), which took effect nationwide
on January 1, 2026. As the world’s first next-generation long-acting G-CSF utilizing human serum
albumin (“HSA”) fusion technology, Mailisheng’s inclusion in the national reimbursement list brings
dual improvements in efficacy and safety, helps optimize the drug list structure, and further enhances
treatment adherence.

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Management Discussion & Analysis

Maiweijian (邁衛健 ®): a Biosimilar of Denosumab
Maiweijian is among the first biosimilars of denosumab (120mg) approved for the treatment of giant cell
tumor of the bone in China. Denosumab is a targeted drug that binds to and inhibits RANKL, a protein
regulating bone cell activity. By neutralizing RANKL, denosumab reduces bone resorption and increases
bone mass and strength. Originally approved in the U.S. in 2010 under the brand name XGEVA®(安加維 ®),
denosumab is indicated for the prevention of skeletal-related events in patients with bone metastases
from solid tumors.
In March 2024, the NMPA approved the NDA for Maiweijian, authorizing for the treatment of giant cell
tumors of the bone that is unresectable or where surgical resection may lead to severe functional
impairment. In May 2026, the supplemental application for Maiweijian for the SREs indication (for the
treatment of patients with bone metastases from solid tumors and patients with multiple myeloma, to
delay or reduce the risk of skeletal-related events, including pathologic fracture, spinal cord compression,
bone radiotherapy, and bone surgery) was approved.
On the overseas commercialization front, Maiweijian was approved for marketing in Pakistan in
August 2025, making it the first XGEVA® biosimilar approved in the country. In February 2026, Taikang
Biopharmaceutical successfully passed the GMP on-site inspection conducted by the Jordan Food and
Drug Administration for denosumab. In addition, as of the Latest Practicable Date, the Company has
signed formal cooperation agreements with 33 countries including Brazil, Colombia, Indonesia, Singapore,
Pakistan, Thailand, Egypt, Peru, and Saudi Arabia for 9MW0321, and has submitted registration application
documents to 8 countries including Jordan, Egypt and Brazil. We are in the course of preparation for the
application for registration in other countries.

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15
Management Discussion & Analysis

6MW5311: a T-cell engager (“TCE”) Targeting CD3 and Leukocyte Immunoglobulin-like
Receptor Subfamily B Member 4 (“LILRB4”)
6MW5311 is a TCE targeting CD3 and LILRB4, designed for the treatment of relapsed or refractory acute
myeloid leukemia (“AML”), chronic myelomonocytic leukemia (“CMML”), and relapsed or refractory
multiple myeloma (“MM”).
LILRB4 is a type I membrane protein whose cytoplasmic domain contains immunoreceptor tyrosine-based
inhibitory motifs (“ITIMs”). It is predominantly expressed on myeloid cells and negatively regulates
immune cell activation. The receptor is upregulated in monocytic AML and is also expressed in CMML and
MM. 6MW5311 simultaneously binds to CD3 and LILRB4, bridging T cells and tumor cells and promoting
the formation of immune synapses. With that, 6MW5311 activates T cells to kill the tumor cells. With
a unique structural design, 6MW5311 has an extremely low binding activity to T cells in a tumor-free
environment. In contrast, in a microenvironment where tumors and T cells coexist, 6MW5311 exhibits
a strong killing effect to the tumor cells, thereby significantly improving safety while ensuring efficacy.
Preclinical studies have shown that 6MW5311 effectively inhibits tumor growth in AML models with both
high and low LILRB4 expression, and nearly completely eliminates tumors in high-expression models.
Cynomolgus monkey safety assessments have also demonstrated a favorable safety profile. In June 2026,
the IND applications for 6MW5311 in hematologic malignancies (AML, CMML and MM) received FDA
clearance and subsequent approval from the NMPA.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET 6MW5311 SUCCESSFULLY.

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

16
Management Discussion & Analysis

Immunology
Key Product 9MW1911: A ST2-targeting Monoclonal Antibody for Treatment of Autoimmune
Diseases
9MW1911 is China’s first homegrown monoclonal antibody targeting ST2. The interleukin-33 (“IL-33”)/ST2
signaling pathway plays a significant role in various inflammatory responses, including chronic obstructive
pulmonary disease (“COPD”). Interleukin-33 (IL-33) is a member of the IL-1 cytokine family. It is a cytokine
released during tissue damage and inflammation, and is predominantly expressed in tissue and immune
cells. It exerts its effects on target cells by binding to a heterodimeric receptor complex composed
of ST2 and IL-1RAcP, which subsequently activates downstream intracellular signaling pathways. The
ST2, also known as the IL-33 receptor, upon activation, triggers downstream proteins and mediates
responses to IL-33. The IL-33/ST2 pathway is closely associated with the pathogenesis and progression
of various inflammatory diseases, and has been clinically validated as an effective therapeutic target
for inflammatory/allergic conditions. Moreover, the IL-33/ST2 pathway acts upstream of the IL-4/IL-13
signaling pathway targeted by dupilumab (IL-4Rα-targeting) marketed by Sanofi, thus offering a broader
pharmacological profile.
Dupilumab, an antibody targeting IL-4Rα, is approved and marketed by Sanofi in the U.S., Europe, and
China. Therefore, 9MW1911 has a broader pharmacological profile compared to dupilumab. In addition,
dupilumab has shown positive advances in COPD and is indicated for patients with type 2 inflammation
in COPD (with blood eosinophils ≥300 cells/μL at screening) and does not limit smoking cessation in
the population. However, epidemiologically, COPD is predominantly characterized by patients with
eosinophil counts less than 300 cells/μL. In a study analyzing eosinophil levels in patients with COPD,
only approximately 31% of the total number of COPD patients has eosinophil counts ≥300 cells/μL.
Similarly, preliminary results of TSLP antibody have demonstrated that TSLP antibody is also effective in
patient populations with high eosinophil levels. In contrast to dupilumab and TSLP targeting antibody,
drugs targeting the ST2/IL-33 pathway do not limit eosinophil counts, suggesting a broader population for
9MW1911.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

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Management Discussion & Analysis

We completed two Phase I clinical trials in healthy participants in China in October 2022 and June 2023,
respectively. We initiated the Phase Ib/IIa trial in patients with COPD in China in July 2023 and Phase
IIa was completed in March 2026. We initiated another Phase II trial in patients with COPD in China in
July 2025 and expect to conduct an interim analysis after obtaining 52-week visit data from at least 120
subjects. The study completed dosing of the last subject in June 2026 and is currently in the subject
follow-up phase. We plan to advance 9MW1911 to a Phase III clinical trial in patients with COPD in China
around the end of 2026. In December 2025, the FDA granted the IND approval to conduct a Phase IIa
clinical trial of 9MW1911 targeting COPD in the U.S.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET 9MW1911 SUCCESSFULLY.
9MW3811: A Humanized Monoclonal
Fibrosis-Related Diseases and Cancer

Antibody

Targeting

IL-11

for

Treatment

of

IL-11 is a cytokine with a critical role in chronic inflammation and fibrosis-related diseases, and is
also closely associated with the pathogenesis of aging-related disorders. 9MW3811 is an innovative
monoclonal antibody we developed in-house. With a high binding affinity and strong neutralizing
activity against IL-11, 9MW3811 may effectively block the downstream signaling pathway mediated
by IL-11, thereby intervening in the pathological process involved in certain chronic inflammation and
fibrosis-related diseases. We applied the LALA modifications (L234A/L235A) to the fragment crystallizable
(“Fc”) region of 9MW3811 to eliminate its binding to various Fc receptors on the immune cells, thereby
reducing the risk of Fc-mediated toxicity. This modification may also lead to a longer half-life of 9MW3811,
as confirmed in the clinical trials, by reducing the liver metabolism of 9MW3811.
9MW3811 has demonstrated significant therapeutic efficacy in multiple animal models of pulmonary
fibrosis. In the mouse model, 9MW3811 significantly reduced the area of pulmonary fibrosis, decreased
lung collagen content, and improved lung function, suggesting its potential as an effective treatment for
pulmonary fibrosis-related diseases. In addition, 9MW3811 has shown notable efficacy results in several
other fibrosis-related indications, such as scar growth inhibition and abnormal uterine bleeding. Our
preclinical studies of 9MW3811 were published in npj Precision Oncology in May 2025, which detailed
the molecular advantages of 9MW3811: (1) superior IL-11/IL-11R signaling blockade efficiency and higher
binding affinity; and (2) molecular design that confers a half-life of over one month in humans, making it
more suitable for chronic diseases requiring long-term administration.
9MW3811 has received multiple IND approvals from regulatory authorities worldwide. We completed the
Phase I clinical trial of 9MW3811 in healthy participants in Australia and China in December 2023 and
May 2024, respectively. Furthermore, we received IND approval from the FDA for clinical trials targeting
idiopathic pulmonary fibrosis in June 2023. In November 2025, the NMPA approved an IND application
for clinical trials of 9MW3811 targeting pathological scars (including hypertrophic and keloids), making
9MW3811 the first clinical stage drug candidate targeting IL-11 for the treatment of pathological scars
(including hypertrophic and keloids). We initiated clinical trials of 9MW3811 targeting pathological scars
(including hypertrophic and keloids) in December 2025. The first patient has been dosed, positioning
9MW3811 as the world’s first IL-11-targeting antibody drug to be investigated in the pathological scar
indication.
In June 2025, we entered into an exclusive license agreement with Calico Life Sciences LLC (“Calico”),
granting Calico the exclusive rights to develop, manufacture, and commercialize IL-11-targeting therapies
(including 9MW3811) in all territories outside Greater China.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET 9MW3811 SUCCESSFULLY.

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Management Discussion & Analysis

9MW5211: A Monoclonal Antibody for Treatment of Autoimmune Diseases
9MW5211 is a highly specific depleting innovative antibody independently developed by the Company,
which enables precise intervention targeting key pathological mechanisms mediated by aberrant immune
cells in autoimmune diseases. Aberrant activation and tissue infiltration of immune cells constitute core
driving factors for the onset and progression of various autoimmune diseases. The molecule targeted
by 9MW5211 is specifically expressed on the surface of pathogenic immune cells and serves as an
important biological marker for abnormal activation of such cells. By selectively recognizing and depleting
this population of pathogenic cells, 9MW5211 can effectively block immune cascade reactions, thereby
slowing disease progression and ameliorating clinical symptoms.
Following multiple rounds of molecular engineering optimization, 9MW5211 exhibits superior target
selectivity. While achieving potent blocking activity, it substantially reduces the risk of nonspecific
binding, enabling profound depletion of pathogenic cells with high expression of the target protein. This
unique mechanism of action is expected to deliver deeper disease remission and may support longer
dosing intervals, improving treatment compliance and quality of life for patients.
Preclinical study results demonstrate that 9MW5211 displays prominent therapeutic potential in multiple
mouse autoimmune disease models, covering indications including inflammatory bowel disease (“IBD”),
multiple sclerosis (“MS”), primary biliary cholangitis (“PBC”), type 1 diabetes mellitus (“T1DM”), and
vitiligo. In parallel, safety assessments conducted in cynomolgus monkey models have indicated a
favorable safety profile.
In May 2026, the IND application for 9MW5211 in IBD received FDA clearance. In June 2026, the IND
applications for IBD and MS were successively approved by the NMPA; in the same month, the first
subject was dosed in the Phase I clinical trial of 9MW5211 in China. In July 2026, the IND applications
for T1DM, PBC, and vitiligo were successively approved by the NMPA. The Company is also actively
advancing IND submissions for additional indications.
As the world’s first clinical-stage candidate drug for such target, 9MW5211 is poised to usher in a new
era of precision therapy for autoimmune diseases.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET 9MW5211 SUCCESSFULLY.
Junmaikang (君邁康 ®): A Biosimilar of Adalimumab
Junmaikang is a biosimilar of adalimumab, which targets and neutralizes the inflammatory cytokine TNF-α.
By blocking TNF-α, it reduces inflammation and modulates immune system activity. Adalimumab was first
approved for medical use in the U.S. in 2002, marked under the brand name Humira. It is widely used to
treat various autoimmune and inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis,
ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurative, and
uveitis.

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Management Discussion & Analysis

In March 2022, the NMPA approved the NDA for Junmaikang, authorizing its use for the treatment of
rheumatoid arthritis, ankylosing spondylitis, and psoriasis, thereby enabling its commercialization.
Subsequently, in November 2022, the NMPA approved a supplemental application for Junmaikang to add
additional indications including Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, pediatric
plaque psoriasis, and pediatric Crohn’s disease. As of the Latest Practicable Date, Junmaikang has been
included in the National Reimbursement Drug List of China; we have entered into commercialization
agreements in 17 countries, including the Philippines, Morocco, and Argentina, and have submitted
registration applications in 6 countries, including Pakistan, Jordan and Peru; in December 2025,
Junmaikang was approved for marketing in Indonesia, which is a PIC/S member country.

Orthopedics
1MW5011 (RP901): A Small Molecule Drug for Treatment of Osteoarthritis
Osteoarthritis is a chronic degenerative disease characterized by joint pain caused by various factors,
leading to fibrosis, chafing, ulceration, and loss of articular cartilage. It significantly affects patients’
quality of life and has become the fourth most disabling disease. The incidence of osteoarthritis is closely
related to gender and age.
The primary purpose of osteoarthritis treatment is to relieve the pain, maintain or improve the joint
function, and protect the joint structure. Current treatment options include pain relievers such as
oral and topically applied non-steroidal anti-inflammatory drugs, as well as intra-articular injections
of glucocorticoids and sodium hyaluronate. Commonly used oral drugs include non-steroidal antiinflammatory drugs, opioids, joint cartilage protectors (such as glucosamine, chondroitin, diacerein).
However, long-term use of non-steroidal anti-inflammatory drugs can cause adverse reactions such as
gastrointestinal bleeding and perforation, and also increase the risk of cardiovascular disease. Opioids are
only suitable for short-term treatment of severe chronic bone and joint pain due to their addictiveness
and potential safety hazards such as respiratory depression. Moreover, the current treatment options
cannot alter the natural progression of osteoarthritis. Many patients fail to receive timely and effective
treatment for various reasons, resulting in prolonged illness and eventual disability.

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Management Discussion & Analysis

1MW5011 (RP901) is a new chemical entity that exerts bone protection and improves/treats osteoarthritis
by rapidly converting into N-butyryl glucosamine in vivo after oral administration. Preclinical
pharmacodynamic studies showed that N-butyryl glucosamine significantly promoted the proliferation
of bovine chondrocytes and proteoglycan synthesis, and increased the expression of type II collagen in
rat chondrocytes. Preclinical studies using articular cartilage from osteoarthritis patients and healthy
subjects showed that N-butyryl glucosamine significantly promoted chondrocyte anabolism and inhibited
chondrocyte catabolism. Radioisotope labeling in rats and monkeys showed that, after oral administration
of [14C] N-butyryl glucosamine, strong radioactivity was detected in the bones, bone marrow and knee
joint-related areas, underscoring its high oral bioavailability and good distribution within bone joints. In
a Phase II clinical trial of 1MW5011 (RP901) for the treatment of knee osteoarthritis, the first patient was
dosed in July 2024, and the trial is expected to be completed in 2028. In addition, we initiated a Phase
Ib clinical trial of 1MW5011 (RP901) to evaluate its safety, tolerability and preliminary efficacy in patients
with knee osteoarthritis in December 2025. Enrollment of the last subject was completed in April 2026,
and the trial is currently in the subject follow-up phase.
WE MAY NOT
SUCCESSFULLY.

BE

ABLE

TO

ULTIMATELY

DEVELOP

AND

MARKET

1MW5011

(RP901)

Mailishu (邁利舒 ®): A Biosimilar Drug of Denosumab
Mailishu is the second approved biosimilar of denosumab for the treatment of osteoporosis in China.
Denosumab is a targeted therapy that functions as a RANKL inhibitor, preventing osteoclast-mediated
bone resorption. By inhibiting RANKL, denosumab reduces bone loss and increases bone mass and
strength in patients at high risk of fractures.
In March 2023, the NMPA approved the NDA for Mailishu, authorizing its use for the treatment of
osteoporosis in postmenopausal women at high risk of fracture. We will continue to explore Mailishu
in other types of osteoporosis. In August 2025, Mailishu received marketing approval in Pakistan. As of
the Latest Practicable Date, Mailishu had been included in NRDL in China. We believe that Mailishu can
provide a new, cost-effective biosimilar treatment option for patients requiring RANKL targeting therapy
to manage their osteoporosis. By offering a high-quality version of the approved denosumab biologic,
Mailishu aims to improve patient access and affordability for this important therapy, helping preserve
bone mass and strength in those at elevated fracture risk.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

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Management Discussion & Analysis

On the overseas commercialization front, in February 2026, Taikang Biopharmaceutical, successfully
passed the GMP on-site inspection conducted by the Jordan Food and Drug Administration for
denosumab. This marks the first time the Company has passed a GMP on-site inspection by a drug
regulatory authority from a PIC/S member country. Previously, the product received registration approval
from the Drug Regulatory Authority of Pakistan, making it not only the first Prolia® biosimilar approved
in Pakistan, but also the Company’s first product to obtain an overseas registration approval, thereby
accelerating the Company’s global expansion. As of the Latest Practicable Date, for 9MW0311, the
Company has entered into formal collaboration agreements with 33 countries, including Brazil, Colombia,
Indonesia, Singapore, Pakistan, Thailand, Egypt, Peru, and Saudi Arabia, and has submitted registration
applications in 8 countries, including Jordan, Egypt, and Brazil. Registration applications in other countries
are also in the course of preparation. The Company will continue to leverage its existing commercial
network and expansion capabilities in emerging markets to rapidly advance collaboration and registration
for this product in overseas markets. In addition, the Company is actively exploring innovative business
models. In 2024, the Company entered into the tripartite Mabwell Bio Bone-Health Innovative Drug Project
Contract jointly with the Chongqing Administration Committee of Hi-tech Industrial Development Zone
and Chongqing Zhongxin Pharmaceutical Big Health Private Equity Investment Fund Partnership (the “Big
Health Fund”). With Mabwell Chongqing as the project entity for implementing this initiative, the three
parties jointly invested in the construction of the “Mabwell Bio Bone-Health Innovative Drug Project”. As
of the Latest Practicable Date, Mabwell Chongqing has received the first-tranche capital contribution of
RMB200 million paid by the Big Health Fund.

Ophthalmology
9MW0211: A VEGF-A Targeting Monoclonal Antibody for the Treatment of Ophthalmology
Disease
9MW0211 is a recombinant, humanized mAb that targets VEGF-A, the most biologically active member
of the VEGF protein family. 9MW0211 was developed using rabbit mAb and humanization modification
technologies, designed for the treatment of VEGF targeting treatment related disease as potential
indications, such as neovascular (wet) age-related macular degeneration (“nAMD”), diabetic macular
edema (“DME”), and retinal vein occlusion (“RVO”). By specifically binding to and neutralizing VEGF-A,
9MW0211 blocks its interaction with receptors on the surface of endothelial cells. This further reduces
vascular permeability and inhibits the generation and progression of abnormal blood vessel growth. As
a consequence, 9MW0211 inhibits the pathological neovascularization and vascular leakage underlying
ocular diseases. The Company completed the Phase II/III clinical trial in December 2025 and is currently
preparing for subsequent clinical studies of this drug candidate.

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Management Discussion & Analysis

The Company presented the results of the Phase II/III clinical study evaluating the efficacy and safety
of the recombinant anti-VEGF humanized monoclonal antibody injection 9MW0211 in nAMD in oral
presentations at Retina China 2026 in May 2026 and at the 40th World Ophthalmology Congress (“WOC”)
in June 2026. Results showed that the 9MW0211 1.5 mg Q4W group achieved a mean best-corrected
visual acuity (“BCVA”) improvement from baseline of 14.1 letters at week 52, which was non-inferior to
the ranibizumab Q4W group. In terms of anatomical efficacy endpoints, the 9MW0211 1.5 mg Q4W group
demonstrated a mean reduction in central retinal thickness (“CRT”) of 205.6μm at week 52, compared
with a reduction of 141.0μm in the ranibizumab group, showing a greater advantage in fluid resolution.
Moreover, the proportion of patients without intraretinal and subretinal fluid in the 9MW0211 Q4W group
was consistently higher than that in the ranibizumab group at weeks 12, 24, and 52. In terms of safety,
the incidence of treatment-emergent adverse events (“TEAEs”) was comparable between the 9MW0211
pooled dose groups and the ranibizumab group.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET 9MW0211 SUCCESSFULLY.
9MW0813: A Biosimilar Drug of Aflibercept
9MW0813 is a biosimilar of aflibercept, a recombinant human VEGF receptor-antibody fusion protein.
Aflibercept acts as a VEGF trap, binding to and neutralizing VEGF. By preventing VEGF from interacting
with its receptors on endothelial cells, aflibercept inhibits the signaling pathway that drives abnormal
blood vessel growth and increased vascular permeability. First approved in the U.S. in 2011 and marketed
under the brand name Eylea, aflibercept is used to treat wet AMD. Aflibercept was subsequently
approved for treating certain types of metastatic colorectal cancer, in combination with chemotherapy.
The Company filed the NDA with the NMPA, which was accepted in September 2025, which is currently
under registration review. 9MW0813 has the potential to serve as a high-quality, cost-effective biosimilar
treatment option for ocular diseases characterized by abnormal blood vessel growth and increased
vascular permeability.
In May 2026, the Company presented the Phase III clinical study results of 9MW0813 in DME in an
oral presentation at Retina China 2026. On the overseas commercialization front, in July 2026, the
Company entered into license agreements with local partners in the Philippines, Vietnam, and Malaysia,
respectively, pursuant to which the Company will collaborate with such partners to advance the local
registration and commercialization of 9MW0813. In the same month, the Company entered into a
license agreement with SVAX Inc., a Saudi Arabian biopharmaceutical company, establishing an in-depth
collaboration on the registration, manufacturing, and commercialization of 9MW0813 in the Gulf Arab
states. Prior to that, the Company had entered into a supply and commercialization agreement with an
Indian pharmaceutical company, granting it exclusive rights to import, manufacture, register, launch, and
sell 9MW0813 in India, as well as non-exclusive rights in 10 countries, including certain countries in South
Asia and Africa. These collaborations mark a solid step forward for the Company in the Middle East,
South Asia, and Africa, while also enhancing the accessibility of the Company’s products to local patient
populations.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

23
Management Discussion & Analysis

WE MAY NOT BE ABLE TO ULTIMATELY OBTAIN MARKETING APPROVAL FOR
COMMERCIALIZE 9MW0813 SUCCESSFULLY.

AND

Hematology
9MW3011: A TMPRSS6 Targeting Antibody for the Treatment of Blood Disease
9MW3011 is one of the globally leading TMPRSS6-targeting therapies in development. It is a recombinant
humanized anti-TMPRSS6 monoclonal antibody, independently developed by Mabwell (USA), one of our
wholly-owned subsidiaries. Its target is primarily expressed on the surface of hepatocyte membranes.
9MW3011 specifically binds to TMPRSS6, upregulates the expression of hepcidin in hepatocytes, inhibits
iron absorption and release, reduces serum iron levels, and thereby regulates iron homeostasis in the
body.
Hepcidin is the core hormone that regulates systemic iron homeostasis. It binds to its receptor
ferroportin, promoting its internalization and degradation, thereby reducing intestinal iron absorption
and the release of stored iron from macrophages and hepatocytes, ultimately controlling blood iron
levels. The target of action, TMPRSS6, is a type II transmembrane serine protease encoded by the
TMPRSS6 gene, predominantly expressed in the liver, and serves as a key negative regulator of hepcidin
expression. As an anti-TMPRSS6 monoclonal antibody, 9MW3011 specifically binds to TMPRSS6, blocking
its inhibitory effect on the BMP/SMAD pathway, thereby upregulating hepcidin expression, inhibiting iron
absorption and release, and reducing serum iron levels. Nonclinical study results have demonstrated
that 9MW3011 is well-tolerated with a favorable safety profile. In a mouse model of polycythemia vera,
treatment with an anti-TMPRSS6 antibody significantly reduced red blood cell counts, hemoglobin levels,
and hematocrit, showing marked therapeutic efficacy.
Given the important role of TMPRSS6 in the hepcidin-ferroportin axis and its relative target specificity,
targeting TMPRSS6 may have potential therapeutic applications in a range of iron metabolism disorders,
including iron-overload anemias such as thalassemia, as well as erythrocytic diseases that may benefit
from restricted iron utilization, such as polycythemia vera. Currently, these indications are recognized
as rare diseases in various regions worldwide. Most of the approved or clinically developing drugs in
this area are small molecules, peptides, oligonucleotides, or gene therapies, which are associated with
significant unmet clinical needs in terms of safety, tolerability, and patient compliance. In contrast,
9MW3011 offers advantages of a long half-life, favorable safety profile, and low treatment cost. By
modulating iron homeostasis, it has the potential to provide a novel therapeutic approach for conditions
such as iron-overload anemias and polycythemia vera.
A project with a mechanism of action similar to that of 9MW3011 is Rusfertide from Protagonist, which
was licensed in by Takeda in February 2024 with an upfront payment of USD300 million. Rusfertide is an
exogenous hepcidin mimetic that directly mimics the function of hepcidin to regulate iron homeostasis
in humans. The Phase III clinical study protocol is once-weekly dosing and its marketing application
has currently been accepted by the FDA. On March 3, 2025, Takeda/Protagonist jointly announced that
the registrational Phase III clinical study of this drug in patients with polycythemia vera not adequately
controlled by standard therapy (including phlebotomy) met its primary endpoint, demonstrating that
this strategy of upregulating hepcidin for the treatment of polycythemia vera is safe and effective,
and validating the scientific validity and feasibility of this pathway mechanism. According to market
research by Takeda/Protagonist, there are approximately 155,000 patients with polycythemia vera in the
United States, with a median survival of 14 years after diagnosis. Rusfertide is initially positioned as an
intermediate-line therapy for polycythemia vera, with estimated annual sales exceeding USD2 billion.

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Management Discussion & Analysis

9MW3011 upregulates endogenous hepcidin expression by modulating upstream signals of this pathway,
potentially providing a more physiologically relevant iron regulation effect. Considering that blood
disorders associated with iron dyshomeostasis typically require long-term administration, endogenous
drug may offer a better safety profile. 9MW3011 can support once-every-four-weeks dosing, offering
greater convenience, and may improve patient compliance. 9MW3011 has the potential to become a
leading macromolecular drug globally for regulating iron homeostasis.
In January 2023, Mabwell (USA), one of wholly-owned subsidiaries of the Company, entered into an
exclusive license agreement with DISC MEDICINE, INC (“DISC”) in respect of 9MW3011. Under the
agreement, DISC was granted exclusive rights to develop, manufacture, commercialize, and otherwise
exploit 9MW3011 in all territories outside Greater China and Southeast Asia. Mabwell (USA) is eligible to
receive aggregate upfront and milestone payments of up to USD412.5 million, as well as royalties at a
percentage up to the low double digits on net sales of licensed products. To date, DISC has paid Mabwell
(USA) a one-time, nonrefundable upfront payment of USD10 million and three milestone payments.
In September 2023, 9MW3011 injection received FTD from the FDA for the treatment of polycythemia
vera; in February 2024, it was granted ODD by the FDA.
As of the Latest Practicable Date, no TMPRSS6-targeting drug has been approved and there were seven
clinical-stage TMPRSS6-targeting investigational drugs worldwide. Among them, 9MW3011 is the first such
drug in China, and is currently the only TMPRSS6-targeting monoclonal antibody globally for the treatment
of polycythemia vera. We completed a Phase I trial in healthy subjects in China in May 2024, and we are
conducting two Phase Ib clinical trials in patients with polycythemia vera in China.
We have completed last patient enrollment in one of the Phase Ib clinical trials for polycythemia vera, and
the clinical trial is expected to be completed by the second half of 2027. For another one, we completed
first patient enrollment in January 2025, last patient enrollment in November 2025 and last patient visit in
June 2026.
In June 2026, the Phase Ib clinical study (CTR20240408) results of 9MW3011 in patients with polycythemia
vera were presented as a poster at the 2026 European Hematology Association (EHA) Annual Congress
(Abstract No. PF-908; Title: A PHASE IB STUDY OF 9MW3011, A FIRST-IN-CLASS ANTI-TMPRSS6 ANTIBODY,
IN RELAPSED/REFRACTORY PATIENTS WITH POLYCYTHEMIA VERA). The study evaluated preliminary
efficacy by assessing the duration and proportion of trial participants achieving a cytoreductive
therapy-free status (i.e., no need for cytoreductive interventions such as hydroxyurea or interferon-α).
Results showed that the median cytoreductive therapy-free duration for the 150 mg Q4W, 150 mg Q2W,
and 300 mg Q4W groups reached 120 days, 139 days, and 197 days, respectively, with a dose-dependent
prolongation. The proportions of participants achieving cytoreductive therapy-free status were 43%, 57%
and 83%, respectively, increasing with higher drug exposure levels. These findings suggest that 9MW3011
has the potential to extend cytoreductive therapy-free duration in polycythemia vera patients, thereby
reducing cytoreduction-related adverse events and improving survival benefits.
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP AND MARKET 9MW3011 SUCCESSFULLY.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

25
Management Discussion & Analysis

Our Technology Platforms
①

Integrated high-efficiency antibody discovery platform
The Company’s integrated high-efficiency antibody discovery platform leverages multiple advanced
technologies to provide a comprehensive and versatile solution for generating monoclonal
antibodies. Equipped with an automated, high-throughput hybridoma discovery system, a single
B cell screening method, a yeast display system, and a fully human mouse antibody generation
system, the platform enables rapid and high-quality antibody discovery across various formats,
including murine, fully human, rabbit-derived, and nanobodies. It is particularly well-suited for
generating antibodies against low-immunogenicity antigens, such as multi-transmembrane
proteins with short extracellular domains or extracellular loop domains. The platform outperforms
traditional discovery methods and is suitable for producing high-potency antibodies with superior
specificity and affinity. Furthermore, it can generate antibodies with diverse functional properties,
including neutralizing antibodies, blocking antibodies, and functional agonists and antagonists,
thereby addressing the specific needs of different therapeutic areas. By integrating these advanced
technologies, the platform accelerates antibody screening, shortens development timelines, and
maximizes the therapeutic potential of antibodies, offering more efficient and targeted solutions
for a broad range of clinical indications.

②

ADC drug development platform
We have established four core ADC technologies for which we possess proprietary intellectual
property (“IP”) rights: DARfinityTM, our self-developed site-specific conjugation process;
IDconnectTM, an optimized design of linker molecules, which bridge antibody and toxins, to achieve
more stable linkage between the antibody and toxins; MtoxinTM, a class of camptothecin-based
novel toxic molecules that are used as the “warhead” in the ADC to kill the targeted cells; and
LysOnlyTM, a structure that allows conditional release of toxins to improve the overall safety and
efficacy profile of the ADC. The advantages of ADC technology are detailed below:
–

DARfinityTM is a site-specific conjugation technology that enables precise and controlled
conjugation of drugs and antibodies to produce highly homogeneous DAR 4 ADCs. The DAR
is a key quality attribute of ADCs. A DAR of 4 is generally considered to provide a sufficient
number of drug molecules per antibody without increasing cytotoxicity. A higher DAR may
lead to increased cytotoxicity and off-target adverse effects, while a lower DAR may render
the drug ineffective. Conventional ADCs typically rely on random conjugation methods,
whereby cytotoxic payloads are attached to multiple sites on the antibody, resulting in a
mixture of ADCs with different DARs (for example, even where the average DAR is 4, the
proportions of DAR 2, DAR 4, DAR 6 and DAR 8 may vary from batch to batch). This results
in substantial heterogeneity between batches, which may affect the efficacy and safety
of ADCs. DARfinityTM overcomes this challenge by carefully selecting specific conjugation
sites and ensuring that the payload is attached only to predetermined sites. DARfinityTM
reduces heterogeneity, such that virtually all ADC molecules in the final product are
consistent in terms of structure and drug loading. Leveraging DARfinityTM, the purity of the
predominant DAR 4 species exceeds 95%. As measured by size exclusion chromatography
and hydrophobic interaction chromatography, the purity of the predominant species can
reach 99% and 97.3%, respectively. Compared to DAR4 ADCs produced by conventional
non-site-specific conjugation processes, DARfinityTM achieves a breakthrough improvement
in monomer purity of the product through its precise site-specific conjugation strategy, and
HIC quantitative analysis shows that the optimization of critical quality attributes exceeds
the industry average. The high-purity, homogeneous conjugation achieved through the
Company’s DARfinityTM technology can improve the key performance attributes of ADC
pharmaceuticals, including pharmacokinetics, stability, as well as safety and efficacy.

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26
Management Discussion & Analysis

–

IDconnectTM is a site-specific conjugation linker technology characterized by an aromatic
ring structure design with self-hydrolysis functionality, which effectively suppresses
premature linker detachment caused by thiol-retro-Michael addition reactions, thereby
avoiding off-target effects and ADC-level depletion resulting from such detachment. In
traditional ADC design, maleimide-based linkers are commonly used to form thioether
bonds with thiol groups in reduced antibodies via thiol-Michael addition reactions, thereby
achieving ADC conjugation. Under certain conditions (such as acidic pH or the presence of
enzymes), the thioether bond can cleave and reverse (termed a thiol-retro-Michael addition
reaction), leading to early dissociation of the drug and premature release of the payload.
If the maleimide is fully hydrolyzed, the reactive site required for the thiol-retro-Michael
addition reaction is eliminated, thereby maintaining stable linkage between the linker and
the antibody. The Company’s IDconnectTM structure is a disubstituted maleimide with two
reactive sites. This linker can react with the four pairs of interchain disulfide bonds in the
antibody (the thiol groups generated after reduction by TCEP) to produce an ADC drug
with a DAR of 4. In addition, each linker can simultaneously conjugate to one pair of the
antibody’s disulfide bonds (reduced thiols), and the Company has designed a difluorophenyl
hydrolysis structure to enhance the stability of the ADC drug. Specifically, the difluorophenyl
structure enables the maleimide to undergo self-hydrolysis. The hydrolyzed maleimide
inhibits retro-Michael addition reactions between the ADC drug and thiol groups in plasma
albumin during blood circulation, thereby preventing toxin release into the bloodstream.
Therefore, through the linker design enabled by IDconnectTM, the Company aims to improve
ADC stability by strengthening the connection between the antibody and the toxin, thereby
reducing premature payload release in plasma.

–

LysOnlyTM is a conditionally releasable structure that utilizes degradation by specific
enzymes to release the toxic payload from the ADC molecule. Through this mechanism, the
ADC molecule can remain intact in the bloodstream and release the payload only within
target cells, thereby reducing off-target toxicity and improving overall safety.

–

MtoxinTM is a novel camptothecin-based payloads. Preclinical studies have shown that,
compared with other cytotoxic payloads commonly used in ADCs (such as DXd and SN38),
MtoxinTM exhibits stronger tumor-inhibitory activity and better bystander killing effects due
to its higher membrane permeability. Despite its enhanced anti-tumor activity, MtoxinTM
does not increase side effects or reduce overall tolerability. Therefore, the Company
believes that MtoxinTM can improve the overall therapeutic efficacy and therapeutic window
of ADC products.

These four proprietary technologies are the pillars of the Company’s ADC product development
platform, IDDCTM, and feature site-specific conjugation, which can help the Company develop
optimized ADCs with greater homogeneity, enhanced stability and purity, potentially improved
efficacy and a better safety profile.
③

TCE bispecific and trispecific antibody development platform
We have developed an in-house TCE bi/tri-specific antibody platform that employs innovative
and differentiated design strategies, offering an integrated solution from molecular design to
manufacturing processes. The platform enables customized development of antibody drugs
tailored to different tumor types and therapeutic needs, significantly enhancing the overall
efficiency from early-stage research through CMC and production.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

27
Management Discussion & Analysis

The platform’s core technological advantages lie in its proprietary CD3 antibody molecular library.
These antibody molecules, which are protected by independent intellectual property rights,
possess varying binding activities and activation potencies: they maintain high binding affinity
to human CD3 while also exhibiting cross-reactivity with cynomolgus monkey CD3. This feature
provides a critical tool for accurately evaluating the safety of TCE molecules in non-human primate
models. Notably, the antibody library covers a complete spectrum of activation potencies, ranging
from strong to mild, thereby offering precise technical support for selective activation tailored to
different tumor indications.
In terms of molecular design, the platform supports the construction of various antibody formats,
including conventional symmetric structures and innovative asymmetric configurations. This
diversified design strategy enables researchers to select the optimal molecular format based on
target characteristics, achieving precise targeting of tumor antigens with varying expression levels.
The most innovative aspect is the “steric hindrance conformation-dependent” design: through
sophisticated molecular engineering, the antibody remains in an inactive state in the bloodstream,
significantly reducing off-target toxicities associated with systemic immune activation. In the tumor
microenvironment, however, specific binding of the Fab domain to tumor-associated antigens
(“TAAs”) triggers a conformational change that exposes the CD3-binding site, thereby enabling
efficient activation of infiltrating T cells. This unique “dual-lock” mechanism ensures excellent
antitumor efficacy while enhancing therapeutic safety.
On target screening front, the Company has established an intelligent target discovery and
assessment system integrating multi-omics analysis, computational biology, and artificial
intelligence technologies. The system employs a three-tier screening strategy: first, bioinformatics
analysis is used to identify therapeutic areas with significant unmet clinical needs; second, the
competitive landscape of existing immunotherapy (“IO”) and ADC pipelines is evaluated; and third,
both validated and novel targets are identified and assessed for the selected indications. This
systematic screening approach ensures the scientific rigor and clinical translation value of target
selection. To date, the system has successfully identified multiple novel targets with promising
development potential.
In addition, another technological breakthrough of the platform is reflected in the development
of trispecific antibodies. By incorporating a second stimulatory signal, the platform significantly
enhances T-cell activation potency and persistence. The R&D team has established a
comprehensive signaling combination screening platform to systematically evaluate various
stimulatory signal combinations, and has developed a proprietary “signal balancing” technology.
This technology ensures that enhanced activity is achieved while maintaining a critical
TAA-dependent activation mode.
To date, the platform has generated multiple preclinical candidate compounds (“PCCs”), which
have demonstrated significant tumor suppression efficacy and favorable safety profiles in
preclinical studies. The platform has advanced 6MW5311 into the clinical stage. The Company
will continue to deepen technological innovation of the platform, with a focus on developing
next-generation TCE technologies, and actively explore combination therapy strategies with IO and
ADC agents, among others. With continued breakthroughs in these technologies, the TCE platform
is expected to become a mainstay in the field of tumor immunotherapy, offering safer and more
effective treatment options for patients worldwide.

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28
Management Discussion & Analysis

Chemistry, Manufacturing & Controls (“ CMC” )
As of June 30, 2026, our CMC team consisted of 130 professionals with experience in process
development, production and quality management from well-known biopharmaceutical and
pharmaceutical companies, and our CMC team leaders had on average approximately 23 years’
experience. Our CMC team is responsible for developing safe, robust, and cost-effective manufacturing
processes for our drug substances and drug products, and ensuring that their quality complies with
regulatory requirements.
Jiangsu Taizhou Manufacturing Facility. Our Jiangsu Taizhou Manufacturing Facility is primarily
dedicated to the production of antibody and recombinant protein drugs. It has an antibody drug
production capacity of 8,000L, recombinant protein drug capacity of 4,000L, and formulation lines capable
of handling 1ml pre-filled syringes and various vial sizes. The facility obtained the Drug Manufacturing
License issued by the Jiangsu Medical Products Administration in 2019, passed the EU Qualified Person
(“QP”) audit in 2021. The antibody production line passed the China GMP compliance inspection in
June 2022, the Colombia INVIMA GMP audit in June 2025, and the GMP inspection by the PIC/S member
countries Jordan and Brazil in 2026. The recombinant protein production line passed the China GMP
compliance inspection in May 2024, and the quality control laboratory obtained CNAS accreditation
in September 2024. The manufacturing facility is currently engaged in the production of clinical-stage
drug supplies for the Company’s pipeline products, as well as commercial manufacturing of denosumab
injection and aldesleukin alfa for injection, with extensive industrialization experience. As of the Latest
Practicable Date, the facility has completed clinical trial material preparation for 12 product candidates
and commercial manufacturing for three products. In total, 159 batches of drug substance have been
produced (41 batches at 200L culture scale, four batches at 500L scale, and 114 batches at 2,000L scale,
with the scale for clinical-stage products consistent with the intended commercial manufacturing scale
after marketing), and 208 batches of drug product have been produced. All batches passed quality
control testing.
Jiangsu Taizhou ADC Manufacturing Facility. Our Jiangsu Taizhou ADC Manufacturing Facility,
spanning over 50,000 square meters, has two ADC antibody substance production lines, two ADC
substance production lines and one ADC product formulation production line. The ADC antibody
substance production line Phase I is designed with a capacity of 6×2,000L. The ADC substance production
line can accommodate ADC bulk production with conjugation scales from 30L to 800L, fulfilling the
conjugation production needs for different types of small molecules with antibody bulk. As of the Latest
Practicable Date, the ADC manufacturing facility had completed clinical trial material preparation for three
pipeline products, namely 9MW2821, 7MW3711, and 7MW4911, with 17 batches of ADC drug substance
and 18 batches of drug product produced. All batches passed quality control testing, marking the
establishment of a full industrial chain layout for the Company’s ADC drugs, spanning from early-stage
research and pharmaceutical development to commercial-scale production of critical registration clinical
trial materials. In addition, in September 2025, the four-party acceptance inspection of the mechanical
and electrical installation works for the antibody manufacturing facility was completed, reaching the
designed capacity of 6 × 2,000L. The antibody facility has now completed installation, commissioning,
and qualification of all utility systems and process equipment, and is ready for trial production, laying the
foundation for the strategic deployment of large-scale antibody drug manufacturing.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

29
Management Discussion & Analysis

Shanghai Jinshan Manufacturing Facility. The project occupies an area of 69,700 square meters
and includes an antibody drug substance production workshop, drug product workshops, and auxiliary
facilities. As of the Latest Practicable Date, two drug substance production lines, one vial drug product
line, and one pre-filled syringe drug product line have been fully put into operation for manufacturing
of clinical samples. The drug substance lines have completed 4 batches at 500L scale and 2 batches at
2,000L scale, with all products passing quality control testing. The pre-filled syringe line has completed 5
batches of media fill (“APS”) validation and 4 batches of pre-filled syringe production, all with satisfactory
validation results and product testing. The vial line has completed APS validation for 3 batches at the
6mL specification and 3 batches at the 10mL specification, all with satisfactory results; in parallel, the
vial line has completed production of 7 batches of drug product, all passing quality control testing. The
facility is now capable of providing manufacturing services from drug substance to sterile drug product
for antibody drugs at various stages, including clinical supplies and commercial production. In terms of
smart manufacturing, the informatization project at Langrun Mabwell has achieved interim milestones.
In the first half of 2026, integrated testing of core business systems including ERP, WMS, and WS was
completed, with successful end-to-end verification of critical business processes and system interfaces,
and all systems operating stably. The Company is currently advancing the integrated validation of
core systems in an orderly manner, providing strong support for digitalized and intelligent production
operations. The Jinshan Manufacturing Facility obtained a certificate of compliance based on an EU QP
audit in January 2025.

Commercialization, marketing and business development
The Company is deeply expanding its domestic market presence and increasing commercial sales
revenue. In the first half of 2026, the Company’s pharmaceutical sales revenue amounted to RMB211.7
million, representing an increase of RMB110.9 million from RMB100.8 million in the same period of
the previous year, reflecting a year-on-year growth of 110.1%, mainly due to the fact that the MAH of
Junmaikang was transferred from Shanghai Junshi Biosciences Co., Ltd. (“Junshi”) to the Company in
July 2025, with invoicing and sales conducted by the Company starting from the fourth quarter of 2025.
In the first half of 2026, domestic pharmaceutical sales revenue of Junmaikang invoiced by the Company
amounted to RMB75.4 million.
In the first half of 2026, the Company established Myvision, a specialized commercialization platform
focused on the full spectrum of ophthalmology, committed to becoming China’s most trusted leader in
ophthalmic innovation ecosystems. In June 2026, it entered into a strategic partnership with VivaVision
Biotech (Zhejiang) Co., Ltd. (“VivaVision”), a leading domestic ophthalmic small-molecule drug R&D
enterprise. Moving forward, both parties will fully leverage their respective core strengths to continuously
deepen their presence in the fields of ocular inflammation and ocular immunology, accelerating the
clinical rollout of more high-quality ophthalmic drugs to benefit patients.
Outside of China, our commercialization and business development efforts target both emerging markets
and developed countries, leveraging strategies such as direct product sales, supplying active ingredients
for local fill-finish, and providing cell lines for local production. For our Core Product and other innovative
pipeline products, we have established a professional global business development team primarily
focused on licensing arrangements in developed countries. We aim to explore and advance overseas
licensing opportunities for novel drugs to maximize their market value. We have also strategically chosen
to commercialize certain relatively mature products, such as biosimilars, in emerging markets through
licensing and collaboration arrangements.

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30
Management Discussion & Analysis

For Junmaikang, the Company has entered into formal collaboration agreements with 17 countries,
including Indonesia, Singapore, Pakistan, the Philippines, Egypt, Morocco and Argentina, and has
submitted registration applications in 6 countries, including Indonesia, Pakistan, Jordan, and Peru.
Approval has been obtained from the Indonesian National Agency of Drug and Food Control and
registration applications in other countries are also being prepared. For Mailishu, the Company has
entered into formal collaboration agreements with 33 countries, including Brazil, Colombia, Indonesia,
Singapore, Pakistan, Thailand, Egypt, Peru, and Saudi Arabia, and has submitted registration applications
in 8 countries, including Jordan, Egypt and Brazil. Approval has been obtained from the Drug Regulatory
Authority of Pakistan, and registration applications in other countries are also being prepared. For
Maiweijian, the Company has entered into formal collaboration agreements with 33 countries, including
Brazil, Colombia, Singapore, Pakistan, Thailand, Egypt, Peru, and Saudi Arabia, and has submitted
registration applications in eight countries, including Jordan, Egypt and Brazil. Approval has been
obtained from the Drug Regulatory Authority of Pakistan, and registration applications in other countries
are also being prepared. As of the Latest Practicable Date, the Company has signed formal collaboration
agreements covering dozens of countries in overseas markets.
For developed regions such as Europe and the United States, as well as leading domestic pharmaceutical
companies, we are advancing broad-based collaboration for its products, particularly innovative pipeline
candidates, through out-licensing and NewCo partnership models. This effort is led by the Business
Development Department, with the core strategic objective of maximizing the value and global reach
of the Company’s R&D pipeline, underpinned by its efficient innovation discovery system and strong
development capabilities. The Company is currently engaged in multiple rounds of business negotiations
with several major international pharmaceutical companies on a range of products, spanning various
stages from data exchange to commercial term discussions.
The Company maintains an active presence at premier domestic and international business development
conferences, industry summits, and cutting-edge academic meetings, including the J.P. Morgan
Healthcare Conference, the BIO International Convention, China Bio, and Bio Europe. Through keynote
speeches, project roadshows, and one-on-one meetings, the Company has established connections
with over one hundred overseas and domestic companies, translating conference engagements into
substantive collaboration leads and negotiation progress. These premier conferences have become key
strategic touchpoints for the Company to connect to the global innovation network, enhance international
brand recognition, and accelerate the out-licensing of its product pipeline. By gaining deep insights into
global industry trends, precisely identifying and engaging with potential partners, and building strategic
trust, the Company continues to strengthen its sustained competitive edge and industry influence in R&D,
providing robust strategic support and resource backing for the international promotion of its product
pipeline.

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Management Discussion & Analysis

To date, the Company has entered into multiple out-licensing agreements for several innovative product
candidates with partners in developed countries. These include an exclusive license agreement with Disc
for 9MW3011, the world’s only TMPRSS6-targeting monoclonal antibody for the treatment of polycythemia
vera; and an exclusive license agreement with Calico for 9MW3811, a first-tier IL-11-targeting monoclonal
antibody addressing significant clinical needs in fibrosis and aging-related diseases. In addition, the
Company has established a NewCo collaboration with Aditum Bio for 2MW7141, a potential world’s first
dual-targeting siRNA molecule utilizing a non-LNP delivery system. The aggregate potential value of these
out-licensing deals is up to USD2 billion. The Company continues to actively explore BD opportunities
for its ADC, TCE and other innovative assets, including the differentiated and innovative CDH17-targeting
ADC, the LILRB4/CD3-targeting TCE bispecific antibody and the ST2-targeting monoclonal antibody.

Intellectual Property
During the Reporting Period, the Company applied for 57 new invention patents and was granted 21
new invention patents, including 15 China-authorized invention patents and 6 national-stage authorized
invention patents. As of June 30, 2026, the Company has 387 invention patent applications, including 276
applications in progress and 111 authorized ones (including 72 invention patents authorized in China, 38
invention patents authorized overseas, and 1 invention patent authorized in Taiwan, China).
Increase for the
Reporting Period

Accumulated number

Number of
applications
(Nos)

Number
of patents
granted
(Nos)

Number of
applications
(Nos)

Number
of patents
granted
(Nos)

Invention patent
Utility model patent
Design patent
Software copyright
Others

57
1
0
0
12

21
5
0
0
26

387
54
6
2
333

111
45
6
2
309

Total

70

52

782

473

Future and Prospects
Looking ahead, the Company will continue to uphold its original aspiration and mission of “Exploring
Life, Benefiting Health”. Driven by innovation and backed by professional talents as the core foundation,
the Company will address unmet clinical needs through original innovation and accelerate commercial
translation of its product pipeline. The Company focuses on oncology and age-related diseases, covering
therapeutic areas including immunology, ophthalmology and orthopedics. To this end, we will accelerate
the clinical progress of core products. Currently, 9MW2821, the Company’s core self-developed Nectin-4
targeted ADC product, ranks first in China and second globally in terms of clinical progress. It is also the
world’s first Nectin-4 targeted drug to advance into Phase III registration clinical trials for CC. At present,
its three core indications, including monotherapy for urothelial carcinoma, combination immunotherapy
and CC, are in the critical Phase III clinical development stage. The Company will continue to prioritize
R&D resources to efficiently advance all clinical studies and preparation for registration applications.
It plans to complete Phase III clinical interim analyzes within 2026 and to subsequently conduct presubmission communications for marketing applications, striving to deliver this innovative therapy with
differentiated efficacy and safety advantages to broad populations of solid tumor patients in China at an
early date.

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32
Management Discussion & Analysis

We will focus on pipeline transformation as the core objective.
While advancing clinical development of our core products, the Company will accelerate the execution of
regulatory review and submission activities for its filed product candidates, as well as subject enrollment
and data readout for products already in clinical stages, ensuring high-quality submission dossiers and
clinical progress in line with expectations, while continuing to pursue novel molecule discovery and
preclinical research in TCE, ADC , differentiated monoclonal antibodies and other innovative molecules.
On the foundation of our in-house R&D capabilities, we will also explore to strengthen commercial
collaborations with leading global pharmaceutical companies, thereby further expanding our global
commercial footprint.

III.

FINANCIAL REVIEW
Overview
We are a pharmaceutical company in China recognized for our ability to innovate in drug development
and for our end-to-end operational capabilities from drug discovery to commercial sales. Our pipeline
focuses on oncology and age-related diseases, which pose significant health risks globally with unmet
clinical needs. We have 15 key varieties in the clinical research or marketing stages, including 11
innovative drugs and 4 biosimilars, focusing on immunology, ophthalmology, orthopedics and other fields.
Among them, 4 varieties have been marketed, 1 variety is in the review stage of domestically produced
drug registration and marketing authorization applications, 2 varieties are in the Phase III key registration
clinical stage, and other varieties are in different clinical study stages.
The following discussion is based on, and should be read in conjunction with, the financial information
and the notes included elsewhere in this report.

Loss for the Period
Net loss was RMB524.2 million for the six months ended June 30, 2026, representing a decrease of
RMB28.0 million from RMB552.2 million for the six months ended June 30, 2025. The decrease was
primarily due to the factors set out in the relevant line items in the interim condensed consolidated
statement of profit or loss and other comprehensive income.

Revenue
Our revenue increased by 209.1% from approximately RMB101.1 million for the six months ended June
30, 2025 to approximately RMB312.5 million for the six months ended June 30, 2026. The increase was
mainly driven by the increase of revenue from an increase in out-licensing revenue from Kalexo and DISC,
as well as an increase in sales revenue from the pharmaceutical products Junmaikang.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

33
Management Discussion & Analysis

The following table sets forth the breakdowns of our revenue by nature for the periods indicated.
For the six months end June 30,
2026
(unaudited)

2025
(unaudited)

(RMB in thousands except for percentages)
Sale of products
Out-Licensing and Rendering of Services

212,597
99,856

68.0%
32.0%

101,004
94

99.9%
0.1%

Total

312,453

100.0%

101,098

100.0%

Cost of Sales
Our cost of sales increased by 246.6% from approximately RMB22.1 million for the six months ended June
30, 2025 to approximately RMB76.6 million for the six months ended June 30, 2026. The increase was
mainly driven by an increase in sales volume of Junmaikang.

Gross Profit
Our gross profit increased by 198.6% from approximately RMB79.0 million for the six months ended June
30, 2025 to approximately RMB235.9 million for the six months ended June 30, 2026. The increase was
mainly due to the rise in gross profit from increased sales volume of Junmaikang, as well as the increase
in gross profit from out-licensing business by Kalexo and Disc during the Reporting Period.

Other Income and Gains
Our other income and gains decreased by 64.8% from approximately RMB31.5 million for the six months
ended June 30, 2025 to approximately RMB11.1 million for the six months ended June 30, 2026. The
decrease was mainly due to a decrease in government grants by RMB21.5 million.

Selling and Distribution Expenses
Our selling and distribution expenses increased by 36.4% from approximately RMB102.2 million for the six
months ended June 30, 2025 to approximately RMB139.4 million for the six months ended June 30, 2026.
The increase was mainly due to an increase in marketing fee from RMB39.0 million for the six months
ended June 30, 2025 to RMB61.9 million for the six months ended June 30, 2026, driven by greater
commercialization efforts for our products.

R&D Costs
R&D costs are RMB431.4 million for the six months ended June 30, 2026, representing an increase
of RMB39.3 million from RMB392.1 million for the six months ended June 30, 2025, primarily due to
an increase of RMB14.8 million in laboratory material costs and an increase of RMB18.6 million in
depreciation and amortization expenses.

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34
Management Discussion & Analysis

Administrative Expenses
Our administrative expenses decreased by 9.0% from approximately RMB119.0 million for the six months
ended June 30, 2025 to approximately RMB108.3 million for the six months ended June 30, 2026. The
decrease was mainly due to a decrease of RMB23.2 million in depreciation and amortization expenses, an
increase of RMB5.1 million in salaries and benefits and an increase of RMB4.5 million in consulting fees.

Other expenses
Our other expenses increased by 121.0% from approximately RMB10.0 million for the six months ended
June 30, 2025 to approximately RMB22.1 million for the six months ended June 30, 2026. The increase
was mainly due to an increase in exchange loss.

Impairment Loss and Reversal of Impairment Losses on Financial assets, Net
For the six months ended June 30, 2026, we recorded impairment losses of RMB3.7 million on financial
assets, primarily due to provisions made for new receivables from certain customers.
For the six months ended June 30, 2025, we recorded reversals of impairment losses of RMB3.2 million
on financial assets, mainly attributable to the collection of receivables from certain customers from prior
periods.

Finance Costs
Our finance costs increased by 52.2% from approximately RMB39.3 million for the six months ended June
30, 2025 to approximately RMB59.8 million for the six months ended June 30, 2026. The increase was
mainly due to an increase in interest on repurchase obligation by RMB7.2 million, an increase in interest
on corporate bonds by RMB9.5 million.

Liquidity and Capital Resources
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. Our cash are denominated in RMB,
USD and HK$. In addition, we monitor the utilization of borrowings and, from time to time, evaluate the
options to renew the borrowings upon expiry based on our actual business requirement. We relied on
equity financing, debt financing and sales of our drug products as the major sources of liquidity during
the Reporting Period.
During the Reporting Period, we incurred negative cash flows from our operations and substantially all of
our operating cash outflows resulted from our research and development and administrative activities.
Our operating activities used RMB33.9 million and RMB508.9 million of cash in the first half of 2025 and
the first half of 2026, respectively.
We expect to generate more cash flow from our operating activities, through launching and
commercializing our products, collaboration arrangements with third parties, and enhancing our cost
containment capacity and operating efficiency. In order to bring to fruition our research and development
objectives, we will ultimately need additional funding sources and there can be no assurances that they
will be made available.

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Management Discussion & Analysis

The following table sets forth our cash flows for the periods indicated:
Six months ended June 30,
2026
RMB’000
(Unaudited)

2025
RMB’000
(Unaudited)

Net cash generated used in operating activities
Net cash generated used in investing activities
Net cash generated from financing activities

(508,938)
(140,734)
1,434,501

(33,923)
(100,226)
295,364

Net increase in cash and cash equivalents
Cash and cash equivalents at beginning of the period
Effect of foreign exchange rate changes, net

784,829
1,526,339
(17,236)

161,215
1,227,566
(154)

Cash and cash equivalents at end of the period

2,293,932

1,388,627

Net Cash Generated Used in Operating Activities
For the six months ended June 30, 2026, our net cash generated used in operating activities was
RMB508.9 million, which was primarily attributable to our loss before tax of RMB523.8 million, primarily
adjusted for (i) depreciation of property, plant and equipment of RMB90.9 million, (ii) finance cost of
RMB59.8 million, (iii) decrease in other payables and accruals of RMB47.3 million, and (iv) decrease in
trade payables of RMB85.3 million.
For the six months ended June 30, 2025, our net cash generated used in operating activities was RMB33.9
million, which was primarily attributable to our loss before tax of RMB552.2 million, primarily adjusted for
(i) depreciation of property, plant and equipment of RMB89.5 million, (ii) finance cost of RMB39.3 million,
(iii) increase in other payables and accruals of RMB368.6 million, and (iv) increase in trade receivables of
RMB18.8 million.

Net Cash Generated Used in Investing Activities
For the six months ended June 30, 2026, our net cash generated used in investing activities was
RMB140.7 million, which was primarily attributable to purchases of property, plant and equipment of
RMB61.6 million, and purchases of financial assets measured at FVTPL of RMB142.1 million, partially
offset by proceeds from redemption of financial assets measured at FVTPL of RMB78.6 million.
For the six months ended June 30, 2025, our net cash generated used in investing activities was
RMB100.2 million, which was primarily attributable to purchases of property, plant and equipment of
RMB87.2 million, purchases of financial assets measured at FVTPL of RMB38.1 million, and investments in
associates of RMB17.1 million, partially offset by proceeds from redemption of financial assets measured
at FVTPL of RMB41.9 million.

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

36
Management Discussion & Analysis

Net Cash Generated from Financing Activities
For the six months ended June 30, 2026, our net cash generated from financing activities was RMB1,434.5
million primarily attributable to our new bank borrowing of RMB1,095.3 million, loans from financial
institutions of RMB100.0 million, and proceeds from issue of ordinary shares of RMB1,095.2 million,
partially offset by the repayment of bank borrowings of RMB798.7 million.
For the six months ended June 30, 2025, our net cash generated from financing activities was RMB295.4
million primarily attributable to our new bank borrowing of RMB867.1 million, loans from financial
institutions of RMB100.0 million, and capital contribution from non-controlling shareholders of RMB200.0
million, partially offset by the repayment of bank borrowings of RMB792.5 million.

Cash and Cash Equivalents
For our cash position, please refer to the sub-section headed “Liquidity and Capital Resources” above.

Borrowing and Gearing Ratio
The Group’s total borrowings, including interest-bearing borrowings, as at June 30, 2026 were RMB2,568.0
million, representing an increase of RMB292.4 million compared to RMB2,275.6 million as at December
31, 2025.
As at June 30, 2026 and December 31, 2025, the Group’s bank borrowings of approximately RMB856.3
and RMB882.4 million respectively were secured by the pledge over our patents, or secured by mortgages
over our buildings, construction in progress or land. The terms of the Group’s long-term bank borrowings
range from 2 years to 10 years. As at June 30, 2026, our outstanding loans were denominated in RMB.
The fair values of the borrowings approximate their carrying amounts as the discounting impact is not
significant.
As at June 30, 2026, the effective interest rates for our interest-bearing borrowings ranged from 1.95% to
3.70%.
Our lease liabilities remain at a similar level which is RMB106.2 million as at June 30, 2026 and RMB148.7
million as at December 31, 2025.
The gearing ratio (calculated by dividing the sum of borrowings and lease liabilities by total equity) of the
Group as at June 30, 2026 was 253.6%, representing a decrease of 201.23% compared to 454.8% as at
December 31, 2025.

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Management Discussion & Analysis

Significant Investments
As at June 30, 2026, we did not hold any significant investments (including any investment in an investee
company) with a value of 5% or more of the Group’s total assets.

Material Acquisitions and Disposals
During the six months ended June 30, 2026, we did not have material acquisitions or disposals of
subsidiaries, associates and joint ventures.

Foreign Exchange Risk
The Group has entities operating in the United States of America and in the People’s Republic of China.
Certain of our bank balances, trade receivables, other receivables, other financial assets, trade payables,
other payables, lease liabilities and other financial liabilities are dominated in foreign currencies and are
exposed to foreign currency risk.
As at June 30, 2026, the Group had no foreign exchange hedging instruments and foreign currency
hedging policy. However, our management constantly monitors the economic situation and our Group’s
foreign exchange exposure and will consider appropriate hedging measures in the future should the need
arise.

Capital Expenditure
For the six months ended June 30, 2026, the Group’s total capital expenditure amounted to approximately
RMB61.6 million, which was mostly used in the purchases of items of property, plant and equipment.

Charge on Assets
As at June 30, 2026, the net book value of the Group’s pledged/mortgaged assets used for bank and other
borrowings amounted to RMB1,636.0 million (December 31, 2025: RMB1,564.1 million), which accounted
for approximately 30.9% of the total assets of the Group (as at December 31, 2025: 34.3%). Such assets
primarily include properties, plant and equipment, etc.

Contingent Liability
As at June 30, 2026, the Group did not have any material contingent liabilities. We confirm that as of the
Latest Practicable Date, there had been no material changes or arrangements to our contingent liabilities.

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

38
Management Discussion & Analysis

Employees and Remuneration Policies
As of June 30, 2026, we had a total of 1,356 employees, compared to 1,325 employees as at December
31, 2025.
We enter into individual employment contracts with our employees covering salaries, bonuses, employee
benefits, workplace safety, confidentiality and non-competition, work product assignment clause and
grounds for termination. To maintain our workforce’s skill levels, we provide continuing education and
training programs to improve their technical, professional or management skills. We also provide training
programs to our employees to ensure their awareness and compliance with our policies and procedures.
Furthermore, we provide various incentives and benefits to our employees, including competitive salaries,
bonuses and share-based payment, particularly our key employees.
During the Reporting Period and up to the the Latest Practicable Date, we did not experience any strikes,
labor disputes or industrial action which had a material effect on our business. We believe we have not
experienced any significant difficulty in recruiting staff for our operations.
Our employees’ remuneration comprises salaries, bonuses, provident funds, social security contributions,
and other welfare payments. We have made contributions to our employees’ social security insurance
funds (including pension plans, medical insurance, work-related injury insurance, unemployment
insurance and maternity insurance) and housing funds pursuant to applicable laws and regulations. We
had complied with all statutory social security insurance fund and housing fund obligations applicable to
us under the laws and regulations in China in all material aspects during the Reporting Period and as of
the Latest Practicable Date.
We have adopted and maintained a series of rules, standard operating procedures, and measures to
maintain our employees’ healthy and safe environment. We implement safety guidelines to set out
information about potential safety hazards and procedures. We require employees to participate in safety
training to familiarize themselves with the relevant safety rules and procedures. Also, we have policies
in place and have adopted relevant measures to ensure the hygiene of our work environment and the
health of our employees.
We have also adopted two share schemes. On June 19, 2020, the Company adopted the Pre-IPO Equity
Incentive Plan (as amended on December 31, 2024 by the Shareholders’ resolutions of the Company),
which is not subject to Chapter 17 of the Listing Rules as it does not involve any further grant of
awards by the Company after the Listing. For details, please refer to the paragraph headed “XIV. SHARE
INCENTIVE SCHEMES – Pre-IPO Equity Incentive Plan” of this report. On September 25, 2023, the Company
also adopted Mabwell U.S. Equity Incentive Plan, which is not subject to Chapter 17 of the Listing Rules
as Mabwell U.S. is not a principal subsidiary (as defined under Chapter 17 of the Listing Rules) of the
Company. For details, please refer to the paragraph headed “Appendix IV – Statutory and General
Information – MABWELL U.S. Equity Incentive Plan” of the Prospectus.

Future Plans for Material Investments and Capital Asset
Save as disclosed in this report, we had not authorized any plan for the material investments or
acquisition of capital asset as of the Latest Practicable Date.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

39
Management Discussion & Analysis

IV.

PRINCIPAL RISKS AND UNCERTAINTIES
We believe that there are certain risks involved in our operations, many of which are beyond our control.
Some of the major risks we face include:
•

Development of innovative drugs is time-consuming and costly, and the outcome is uncertain.
If we are not able to successfully develop and commercialize new products, including our Core
Product, our business prospects could be adversely affected.

•

Certain pipelines face fierce competition from existing drugs and drug candidates under
development.

•

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.

•

We invest substantial human and capital resources in R&D to develop our drug candidates, but we
cannot guarantee that such efforts will lead to successful outcomes.

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

40

Corporate Governance and Other Information

I.

INTERIM DIVIDEND
For the six months ended June 30, 2026, the Company has resolved not to pay an interim dividend to
shareholders.

II.

COMPLIANCE WITH THE MODEL CODE FOR SECURITIES TRANSACTIONS
The Company has adopted the Model Code for Securities Transactions by Directors of Listed Issuers
(the “Model Code”) set out in Appendix C3 to the Rules Governing the Listing of Securities on the Hong
Kong Stock Exchange (the “Listing Rules”). Specific enquiries have been made to all Directors and the
Directors have confirmed that they have complied with the Model Code during the period from April 28,
2026 (the “Listing Date”) to the date of this report.
The Company’s employees, who are likely to be in possession of inside information of the Company, have
also been subject to the Model Code for securities transactions. No incident of non-compliance of the
Model Code by the employees was noted by the Company for the Reporting Period.

III.

COMPLIANCE WITH THE CORPORATE GOVERNANCE CODE
The Company recognizes the importance of good corporate governance for enhancing the management
of the Company as well as preserving the interests of the Shareholders as a whole. The Company
has adopted and applied the principles and code provisions as set out in the Part 2 of the Corporate
Governance Code set out in Appendix C1 to the Listing Rules (the “Corporate Governance Code”) as
its own code of corporate governance practices.
During the period from the Listing Date to the date of this report, the Company has complied with all
the applicable code provisions as set out in the Corporate Governance Code, except for code provision
C.2.1 described in the paragraph below. The Board will continue to review and monitor the code of
corporate governance practices of the Company with an aim to maintaining a high standard of corporate
governance.
Pursuant to paragraph C.2.1 of Part 2 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 chairman and chief executive should be segregated and should not be
performed by the same individual. We do not have a separate chairman and chief executive and Dr. Liu
Datao (“Dr. Liu”) currently performs the roles of the chairman of our Board and the general manager of
our Company. Dr. Liu has assumed the role of chairman of our Board since June 2023. He has extensive
experience in the business operations and management of our Group. Our Board believes that, in view of
his experience, personal profile and his roles in our Company as mentioned above, Dr. Liu is the Director
best suited to identify strategic opportunities and focus of the Board due to his extensive understanding
of our business as our general manager. The Board also believes that vesting the roles of both chairman
and general manager in the same person has the benefit of (i) ensuring consistent leadership within
the Group, (ii) enabling more effective and efficient overall strategic planning and execution of strategic
initiatives of the Board, and (iii) facilitating the flow of information between the management and the
Board for the Group. The Board considers that the balance of power and authority for the present
arrangement will not be impaired, and this arrangement will enable the 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 general manager of the Company at a time when it is appropriate by taking
into account the circumstances of the Group as a whole.

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41
Corporate Governance and Other Information

IV.

AUDIT COMMITTEE
We have established an Audit Committee with written terms of reference in compliance with Rule 3.21 of
the Listing Rules and paragraph D.3 of Part 2 of the Corporate Governance Code. The Audit Committee
consists of three Directors, namely Mr. Qin Zhengyu (秦正余), Mr. Zhou Rui (周睿) and Ms. Li Fan (李凡).
Mr. Qin Zhengyu (秦正余), who holds the appropriate professional qualifications as required under Rules
3.10(2) and 3.21 of the Listing Rules, serves as the chairperson of the Audit Committee. The primary
duties of the Audit Committee are to, among others, (i) oversee and evaluate the work of the external
auditors, (ii) propose the appointment, reappointment, change and removal of the external auditors to
our Board, (iii) guide and supervise internal audit work and its implementation, (iv) review the financial
information of our Company and oversee the financial reporting system, risk management and internal
control system of the Company, and (v) deal with other matters that are involved in relevant laws,
regulations, rules, normative documents, the Articles of Associations, terms of reference and the listing
rules of the place where the Company’s shares are listed or that are authorized by the Board.
The Audit Committee has reviewed and agreed with the accounting principles and practices adopted
by the Group and has discussed matters in relation to internal controls and financial reporting with the
management, including the review of the unaudited condensed consolidated interim financial results
of the Group for the six months ended June 30, 2026. The Audit Committee considers that the interim
financial results for the six months ended June 30, 2026 are in compliance with the relevant accounting
standards, rules and regulations and appropriate disclosures have been duly made.

V.

CHANGE IN INFORMATION OF DIRECTORS AND CHIEF EXECUTIVE UNDER
RULE 13.51B(1) OF THE LISTING RULES
On June 18, 2026, Mr. Hu Huiguo retired as executive Director, Mr. Wu Yufeng retired as non-executive
Director, and Dr. Xu Qing and Dr. Zhao Qian retired as independent non-executive Directors due to expiry
of their term of office. On the same date, the election of Mr. Tang Chunshan, Dr. Liu Datao, Dr. Wu Hai
and Mr. Hua Jun as executive Directors, and Mr. Qin Zhengyu, Mr. Zhou Rui, Ms. Li Fan and Ms. Wang
Fang as independent non-executive Directors being passed at the extraordinary general meeting, and
the election of Dr. Gui Xun as an employee representative Director was approved by the trade union
committee. For details, please refer to the announcement of the Company dated June 18, 2026.
Save for the above, since the date of the Prospectus and up to the date of this report, there has been
no change in the information of Directors and senior management that is required to be disclosed under
Rule 13.51B(1) of the Listing Rules.

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42
Corporate Governance and Other Information

VI.

INTERESTS AND SHORT POSITIONS OF OUR DIRECTORS AND CHIEF
EXECUTIVE OF OUR COMPANY IN THE SHARES, UNDERLYING SHARES AND
DEBENTURES OF OUR COMPANY AND OUR ASSOCIATED CORPORATIONS
Save as disclosed below, as of June 30, 2026, so far as our Directors are aware, none of our Directors and
chief executive has any interests and short positions in our Shares, underlying Shares or debentures of
our Company or any of our associated corporations (within the meaning of Part XV of the SFO) (i) which
will have to be notified to us and the Stock Exchange pursuant to Divisions 7 and 8 of Part XV of the SFO
(including interests and short positions in which they are taken or deemed to have under such provisions
of the SFO), or (ii) which will be required, pursuant to section 352 of the SFO, to be entered in the register
referred to therein, or (iii) which will be required to be notified to us and the Stock Exchange pursuant to
the Model Code for Securities Transactions by Directors of Listed Issuers contained in the Listing Rules:

Name
Mr. Tang Chunshan

Dr. Liu Datao

Capacity/Nature
of Interest
Interest in controlled
corporation

Beneficial owner
Beneficial owner(5)

Dr. Gui Xun

Beneficial owner(6)

Approximate
Approximate
percentage of
percentage of
shareholding in shareholding in
the A Shares/ the total Share
Number H Shares as of
capital as of
of Shares(1) June 30, 2026(2) June 30, 2026(2)
169,360,000(3)
A Shares (L)
1,983,800(4)
H Shares (L)

42.38%

37.91%

4.21%

0.44%

15,100,000
A Shares (L)
6,360,000
A Shares (L)

3.78%

3.38%

1.59%

1.42%

0.13%

0.11%

500,000
A Shares (L)

(1)

The letter “L” denotes the person’s long position in the Shares.

(2)

The calculation is based on the total number of 399,600,000 A Shares and 47,130,200 H Shares.

(3)

As of June 30, 2026, Mr. Tang Chunshan (i) directly owns approximately 79.92% partnership interests as limited partner
and indirectly owns, through Shenzhen Langrun Investment Consultancy Management Co., Ltd. (“Langrun Investment
Consultancy”), 0.10% partnership interests as general partner in Langrun (Shenzhen) Equity Investment Fund Enterprise
(Limited Partnership) (“Langrun Equity”), which beneficially owns 140,560,000 A Shares; (ii) directly owns approximately 2.12%
partnership interests as general partner in Ningbo Meishan Free Trade Port Zhongjun Jianlong Investment Partnership (Limited
Partnership) (“Zhongjun Jianlong”), which beneficially owns 20,000,000 A Shares; (iii) directly owns approximately 10.56%
partnership interests as general partner in Ningbo Meishan Free Trade Port Zhenzhu Investment Management Partnership
(Limited Partnership) (“Zhenzhu Investment”), which beneficially owns 6,800,000 A Shares; and (iv) directly owns 88.30% of
the equity interests in Langrun Investment Consultancy, which beneficially owns 2,000,000 A Shares. By virtue of the SFO, Mr.
Tang Chunshan is deemed to be interested in the Shares held by Langrun Equity, Zhongjun Jianlong, Zhenzhu Investment and
Langrun Investment Consultancy.

(4)

Represents 1,983,800 H Shares subscribed by Charm Harvest International Limited through its investment as a cornerstone
investor. Charm Harvest International Limited is wholly owned by Mr. Tang Chunshan.

(5)

Represents 6,360,000 A shares of the Company which is indirectly held by Dr. Liu Datao through Ningbo Meishan Free Trade
Port Zhongjun Jianlong Investment Partnership (Limited Partnership) (寧波梅山保稅港區中駿建隆投資合夥企業(有限合夥)).

(6)

Represents 500,000 A shares of the Company which is indirectly held by Dr. Gui Xun through Ningbo Meishan Free Trade Port
Zhenzhu Investment Management Partnership (Limited Partnership) (寧波梅山保稅港區真珠投資管理合夥企業(有限合夥)).

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

43
Corporate Governance and Other Information

VII. SUBSTANTIAL SHAREHOLDERS’ INTERESTS AND SHORT POSITIONS
As of June 30, 2026, to the knowledge of the Company and the Directors after making reasonable
inquiries, the following persons (other than the Directors and chief executive of the Company as disclosed
above) have interests or short positions in Shares or underlying Shares which would be required to be
disclosed to the Company under the provisions of Divisions 2 and 3 of Part XV of the SFO and recorded in
the register required to be maintained by the Company under Section 336 of the SFO:
Approximate
percentage of
shareholding in
the A Shares/
H Shares as of
June 30, 2026(2)

Approximate
percentage of
shareholding in
the total Share
capital as of
June 30, 2026(2)

Name

Capacity/Nature
of Interest

Number
of Shares(1)

Ms. Chen Shanna(3)

Interest in spouse

169,360,000
A Shares (L)
1,983,800
H Shares (L)

42.38%

37.91%

4.21%

0.44%

Langrun Equity

Beneficial owner

140,560,000
A Shares (L)

35.18%

31.46%

Langrun Investment
Consultancy(4)

Beneficial owner

2,000,000
A Shares (L)

0.50%

0.45%

Interest in controlled
corporation

140,560,000(4)
A Shares (L)

35.18%

31.46%

Beneficial owner

20,000,000
A Shares (L)

5.01%

4.48%

Zhongjun Jianlong

Notes:
(1)

The letter “L” denotes the person’s long position in the Shares.

(2)

The calculation is based on the total number of 399,600,000 A Shares and 47,130,200 H Shares.

(3)

Ms. Chen Shanna is the spouse of Mr. Tang Chunshan. By virtue of the SFO, Ms. Chen Shanna is deemed to be interested in
the Shares in which Mr. Tang Chunshan is deemed to be interested.

(4)

As of June 30, 2026, Langrun Investment Consultancy directly owns approximately 0.10% partnership interests as general
partner in Langrun Equity, which beneficially owns 140,560,000 A Shares. By virtue of the SFO, Langrun Investment Consultancy
is deemed to be interested in the Shares held by Langrun Equity.

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44
Corporate Governance and Other Information

Save as disclosed above and to the best knowledge of the Directors, as at June 30, 2026, the Company is
not aware of any other person (other than the Directors or the chief executive of the Company) who had
an interest or short position in the Shares or underlying Shares as recorded in the register required to be
kept by the Company pursuant to Section 336 of the SFO.

VIII. RIGHTS OF DIRECTORS TO ACQUIRE SHARES OR DEBENTURES
Save as disclosed in this report, as of June 30, 2026, none of the Directors or their respective spouses
or minor children under the age of 18 years were granted with rights, or had exercised any such rights,
to acquire benefits by means of purchasing Shares or debentures of the Company. Neither the Company
nor any of its subsidiaries was a party to any arrangements to enable the Directors or their respective
spouses or minor children under the age of 18 years to acquire such rights from any other body
corporates.

IX.

LEGAL PROCEEDINGS
As of June 30, 2026, as far as the Company is aware, the Company and its subsidiaries were not involved
in any material litigation or arbitration and no material litigation or claim of material importance was
pending or threatened against or by the Company.

X.

PURCHASE, SALE OR REDEMPTION OF THE COMPANY’S LISTED SECURITIES
During the Reporting Period, neither the Company nor any of its subsidiaries purchased, sold or
redeemed any of the Company’s listed securities (including sale of treasury Shares (as defined under the
Listing Rules)).
As of June 30, 2026, the Company held 1,192,369 treasury Shares (as defined under the Listing Rules)
held by the Company and no Shares repurchased but pending cancellation. Such treasury shares will be
used for employee share ownership plans or equity incentives. If the repurchased shares are not utilised
for the aforementioned purposes within three years after the completion of the share repurchase, the
unutilised repurchased shares will be cancelled in accordance with the relevant laws and regulations, and
such cancelation shall be subject to the articles of association, applicable PRC laws and the Listing Rules.

XI.

SHARE CAPITAL
Details of the movements in share capital of the Company during the Reporting Period are set out in Note
10 to the Consolidated Financial Statements of this report.

XII. USE OF PROCEEDS
Use of proceeds from the Global Offering
The Company’s shares were listed on the Stock Exchange on April 28, 2026 with a total of 47,130,200
offer shares issued and the net proceeds raised from the Global Offering were approximately RMB1,047.6
million (equivalent to approximately HK$1,197.1 million). The net proceeds from the Listing (adjusted on
a pro rata basis based on the actual net proceeds) have been and will be utilized in accordance with
the purposes set out in the Prospectus. There was no change in the intended use of net proceeds as
previously disclosed in the Prospectus as follows:
•

Approximately 56.8%, or RMB595.0 million (equivalent to approximately HK$679.8 million), will
be used for the clinical development trials of our Core Product, 9MW2821, at various stages for
multiple indications.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

45
Corporate Governance and Other Information

•

Approximately 17.7%, or RMB185.4 million (equivalent to approximately HK$211.9 million), will be
used for the research and development of other pipeline products focused on oncology and agerelated diseases with significant clinical needs.

•

Approximately 15.5%, or RMB162.4 million (equivalent to approximately HK$185.6 million), will be
used for commercialization purposes.

•

Approximately 10.0%, or RMB104.8 million (equivalent to approximately HK$119.8 million), will be
used to fund the working capital and other general corporate purposes.

The net proceeds from the Global Offering have been utilized in accordance with the purposes set out
in the Prospectus. The table below sets out the applications of the net proceeds and actual usage up to
June 30, 2026:

Percentage
(%)

Planned
allocation of
Net Proceeds
(RMB million)

Utilized
amount
from Listing
Date to
June 30,
2026)
(RMB million)

Remaining
amount
(as at
June 30,
2026)
(RMB million)

Clinical development trials of our Core
Product, 9MW2821
Research and development of other
pipeline products focused on oncology
and age-related diseases
For commercialization purposes

56.8

595.0

0.2

594.8

17.7

185.4

7.4

178.0

15.5

162.4

12.6

149.8

Working capital and other general
corporate purposes(2)

10.0

104.8

98.5

6.3

Total

100.0

1,047.6

118.7

928.9

Use of proceeds

Expected timeline
for utilization of
unutilized net
proceeds(1)

On or before December 31,
2029
On or before December 31,
2028
On or before December 31,
2028
On or before December 31,
2027

(1)

The expected timeline for the utilization of unutilized proceeds represents the Group’s best estimates based on the anticipated
market conditions, which may be subject to change in response to current and future market developments.

(2)

Working capital and other general corporate purposes, including but not limited to loan repayments, payments to suppliers and
the settlement of daily operating expenses.

The above HK$ amounts were converted using the April 28, 2026 exchange rate of RMB1 to HK$1.1427.

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

46
Corporate Governance and Other Information

Use of proceeds from the A Share Offering
According to “the Approval of the Initial Public Offering of Shares by Mabwell (Shanghai) Bioscience Co.,
Ltd.” (Securities Regulatory Permit No. [2021] 3859) approved by the CSRC, the Company was permitted to
make a public offering of 99,900,000 ordinary shares of RMB (A Shares) to the public; and the actual issue
price of A Shares under the offering is RMB34.80 per share. The Company had raised gross proceeds of
RMB3,476.5 million through the public offering of 99,900,000 ordinary shares of RMB to the public. After
deducting issue expenses of RMB173.1 million, the net proceeds amounted to approximately RMB3,303.4
million.
According to the description of the use of proceeds in the A Shares Prospectus, all proceeds raised from
the A Share Offering of the Company, after deducting the issue expenses, will be used for (i) antibody
industrialization construction project with annual output of 1,000kg; (ii) R&D of antibody drug; and (iii)
replenishing working capital. The above proceeds were transferred to the designated accounts of the
Company on January 10, 2022 and the availability of funds has been verified by Ernst & Young Hua Ming
LLP (安永華明會計師事務所(特殊普通合夥)), which has issued the relevant Capital Verification Report.
In the annual general meeting held on April 8, 2024, shareholders’ resolutions were passed to change
the use of proceeds from the A Share Offering to (i) antibody industrialization construction project with
annual output of 1,000kg; (ii) antibody drug pilot industrialization project phase I; (iii) R&D of antibody
drug; and (iv) replenishing working capital.
As of June 30, 2026, the Group had used the net proceeds from the A Share Offering for the following
purposes:

Utilized net
Utilized net
Proposed
proceeds proceeds as at
Investment
during the end of the
Amount from
Reporting
Proceeds the Reporting
Period
Period
Raised
RMB’million
RMB’million
RMB’million
Antibody industrialization
construction project with
annual output of 1,000kg(2)
Antibody drug pilot
industrialization project
phase I
R&D of antibody drug
Replenishing working capital
Total

Proceeds
unutilized
as at the
end of the
Reporting
Period
RMB’million

Expected
timetable(1)

580.0

37.3

347.6

232.4

On or before
December 31, 2029

420.0

32.0

278.7

141.3

On or before
December 31, 2026

1,523.4

156.5

1,257.0

266.4

780.0

0.0

780.0

0.0

On or before
December 31, 2029
N/A

3,303.4

225.8

2,663.3

640.1

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

47
Corporate Governance and Other Information

(1)

The expected timeline for the utilization of unutilized proceeds represents the Group’s best estimates based on the anticipated
market conditions, which may be subject to change in response to current and future market developments.

(2)

On March 30, 2025, the Company convened the 17th meeting of the second session of the Board, the 16th meeting of the
second session of the Board of Supervisors, and the 3rd meeting of the special meetings of independent Directors of the
second session of the Board, respectively, and convened the 2024 annual general meeting on April 21, 2025, at which the
Proposal on Closing Certain Fund-Raising Investment Projects and Permanently Supplementing Working Capital with the
Remaining Proceeds was reviewed and approved. It was approved that the Company closed the “Antibody industrialization
construction project with annual output of 1,000kg”, which is the fund-raising investment project from the initial public offering
of shares (the “Fund-Raising Investment Project”), and permanently supplemented working capital with the remaining
proceeds of RMB189.4 million The outstanding procurement balance payments, warranty deposits, and initial working capital
(including subsequent interest income) under the Fund-Raising Investment Project will continue to be maintained in the special
fund-raising accounts. They will be subject to continued management in special accounts in accordance with the requirements
of the relevant normative documents issued by the China Securities Regulatory Commission and the Shanghai Stock Exchange,
as well as the Company’s standardized operation system, and will be gradually paid out as planned during the future operation
of the Fund-Raising Investment Project.

The net proceeds from the A Shares Offering have been utilized in accordance with the purposes set
out in the A Shares Prospectus. There was no change in the intended use of net proceeds as previously
disclosed in the A Shares Prospectus.

XIII. EVENTS AFTER THE END OF THE REPORTING PERIOD
The Group has no significant events occurred after the Reporting Period which require additional
disclosures or adjustments as at the date of this report.

XIV. CONTINUING DISCLOSURE OBLIGATIONS PURSUANT TO THE LISTING RULES
The Company does not have any disclosure obligations under Rules 13.20, 13.21 and 13.22 of the Listing
Rules.

XV. SHARE INCENTIVE SCHEMES
Prior to the Listing Date, we have adopted a share incentive scheme, namely the Pre-IPO Equity Incentive
Plan, on June 19, 2020 (as amended on December 31, 2024 by the Shareholders’ resolutions of the
Company). The Pre-IPO Equity Incentive Plan is not subject to Chapter 17 of the Listing Rules as it does
not involve any further grant of awards by the Company after the Listing.

Pre-IPO Equity Incentive Plan
Purpose
The main purpose of the Pre-IPO Equity Incentive Plan is to improve the incentive mechanism of the
Group, further enhance the work enthusiasm and creativity of the participants thereto (the “Eligible
Participants”), promote the continued growth of the performance of the Group, and bring economic
benefits to the Eligible Participants while enhancing the value of the Group, so as to realize the common
development of the Eligible Participants and the Group.
Eligible Participants
The Eligible Participants include the Directors, supervisors, senior management, heads of the Company’s
main departments and of other members of the Group, core personnel, and other employees that the
Board recognizes as having made contributions to the Company.

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

48
Corporate Governance and Other Information

Administration
As authorised by the general meeting, the Board serves as the scheme administrator of the Pre-IPO
Equity Incentive Plan, and shall be responsible for, among others:
•

setting and adjusting the conditions for granting awards;

•

determining the identities of the grantees and the corresponding amount of awards to be granted;

•

interpreting and amending the Pre-IPO Equity Incentive Plan; and

•

other matters that the Board shall be responsible for under the Pre-IPO Equity Incentive Plan.

The sole general partner of the Zhenzhu Investment and Zhongjun Jianlong is Mr. Tang Chunshan. The
voting rights attached to the Shares in the Company held by the Employee Incentive Platforms underlying
the awards reside with the sole general partner of the Employee Incentive Platforms. The general partner
of the Employee Incentive Platforms shall be responsible for:
•

arranging execution of the grant agreements, the partnership agreements of the Employee
Incentive Platforms and other relevant documents;

•

maintaining a grantee list for internal record;

•

determining the transferees, methods and prices for the transfer of or withdrawal from holding the
partnership interests of the Employee Incentive Platforms held by the grantees in accordance with
the laws and regulations and the Pre-IPO Equity Incentive Plan; and

•

managing, controlling, operating, and decision-making of the Employee Incentive Platforms.

Form of Awards under the Pre-IPO Equity Incentive Plan
The grantees subscribe for partnership interests of the Employee Incentive Platforms as partners
according to the amount of awards granted under the Pre-IPO Equity Incentive Plan as approved by the
general meeting, and make the corresponding capital contributions in accordance with the arrangements
of the Board, thereby holding indirect interests in the Shares.
Total Number of the Shares underlying the Awards
Zhongjun Jianlong and Zhenzhu Investment, our Employee Incentive Platforms, hold an aggregate of
26,800,000 Shares. Grantees (excluding Mr. Tang Chunshan acting in the capacity of a general partner of
each of the respective Employee Incentive Platforms for this purpose) are indirectly interested in a total
of 25,891,100 Shares, representing approximately 5.80% of the share capital of our Company as of the
Latest Practicable Date, through holding partnership interests in our Employee Incentive Platforms.
Prior to listing of A Shares, all awards, corresponding to a total of 25,891,100 Shares, have been granted
and vested under the Pre-IPO Equity Incentive Plan, and no further awards will be granted thereunder
after the Listing. As no further awards will be granted after Listing and the 26,800,000 Shares have been
issued to the Employee Incentive Platforms prior to listing of A Shares, the Pre-IPO Equity Incentive Plan
will not cause any dilution of the shareholding of our Shareholders after the Listing.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

49
Corporate Governance and Other Information

Term
The Pre-IPO Equity Incentive Plan shall take effect from the date of being approved at the Shareholders’
general meeting. The Board is authorized to review and approve the implementation, amendment and
termination of the Pre-IPO Equity Incentive Plan.
Grant of Awards
The Board shall determine the grantees and the allocation of awards. The Company and the grantee will
execute the grant agreement, and the general partner or designated limited partner of the Employee
Incentive Platforms will execute a share transfer agreement with the grantee. The general partner of
the Employee Incentive Platforms is responsible for the relevant industrial and commercial change
registration procedures. Grantees must subscribe for the partnership interests of our Employee Incentive
Platforms in cash, and should ensure that their source of funds is genuine and lawful. All contribution
payments shall be made fully and timely.
Transfer Restrictions
Except as otherwise stipulated in the Pre-IPO Equity Incentive Plan, prior to the Listing of the Company,
the grantees shall not directly or indirectly dispose the partnership interests held in our Employee
Incentive Platforms, including but not limited to, transferring such partnership interests to any third party,
using such partnership interests as collateral, using such partnership interests to repay debts, or to
establish any other rights over the partnership interests.
In addition, save as otherwise allowed in the Pre-IPO Equity Incentive Plan and with the consent of the
general partner of the Employee Incentive Platforms, the grantees shall not reduce or transfer any of
the partnership interests held in our Employee Incentive Platforms, or directly or indirectly dispose any
of the partnership interests held in our Employee Incentive Platforms, until his awards are released.
The grantees shall have the right to any dividend distribution of our Company corresponding to their
partnership interest in the Employee Incentive Platforms in accordance with the provisions of the
Employee Incentive Platforms. The Board shall determine performance targets set for each grantee (the
“Performance Targets”) in consultation with the employees of the Company. The awards granted under
the Pre-IPO Equity Incentive Plan shall be released as follows upon the Company’s assessment of each
grantee’s satisfaction in the preceding financial year of the Performance Targets set to them:
•

20% of the total number of awards granted to a grantee on March 31, 2022;

•

20% of the total number of awards granted to a grantee by March 31, 2023; and

•

60% of the total number of awards granted to a grantee by March 31, 2024.

The awards have been released, and the grantee may transfer or dispose of their partnership interests in
the Employee Incentive Platforms. However, the grantee may only transfer their partnership interests to
the general partner of the Employee Incentive Platforms. Furthermore, unless they have the consent of
the general partner of the Employee Incentive Platforms or there is change in the status of the Company
or the grantee, the grantee may only transfer their partnership interests that have been released and only
at a consideration negotiated and agreed with the general partner of the Employee Incentive Platforms.

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

50
Corporate Governance and Other Information

Clawback Mechanism
If the Performance Targets are not satisfied during any assessment period or if the grantee leaves
the employ of the Company prior to the release of all of their awards, the partnership interests in our
Employee Incentive Platforms underlying the unreleased awards shall be repurchased by the general
partner of the Employee Incentive Platforms, at the price that the grantee paid for subscription of such
partnership interests.
Details of the Grantees
Prior to listing of A Shares, the awards corresponding to a total of 25,891,100 Shares (excluding an
aggregate of 908,900 Shares corresponding to the partnership interests held by Mr. Tang Chunshan in his
capacity as the sole general partner of each of Zhongjun Jianlong and Zhenzhu Investment), representing
approximately 5.80% of our total issued Shares, have been granted to a total of 94 Eligible Participants
under the Pre-IPO Equity Incentive Plan. There has been no change of the details of the partnership
structure of the Employee Incentive Platform. Please refer to the paragraph headed “Appendix IV –
Statutory and General Information – PRE-IPO EQUITY INCENTIVE PLAN – Details of the Grantees” of the
Prospectus for details.

XVI. PERMITTED INDEMNITY
LIABILITY INSURANCE

PROVISION

AND

DIRECTORS’

AND

OFFICERS’

A permitted indemnity provision (as defined in the Companies Ordinance (Chapter 622 of the Laws of
Hong Kong)) in relation to the directors’ and officers’ liability insurance is currently in force and was in
force during the six months ended June 30, 2026. The Company has arranged appropriate directors’
liability insurance coverage for the Directors of the Group during the six months ended June 30, 2026.

XVII. SUFFICIENCY OF PUBLIC FLOAT
Based on the information that is publicly available to the Company and within the knowledge of the
Directors, the Company had maintained the prescribed public float under Rule 8.08 and Rule 19A.28B(2)
of the Listing Rules during the six months ended June 30, 2026 and up to the date of this Report.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

51

Independent Review Report

Ernst & Young
27/F, One Taikoo Place
979 King’s Road
Quarry Bay, Hong Kong

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Tel 曢婘: +852 2846 9888
Fax ₚ䜆: +852 2868 4432
ey.com

Independent review report
To the shareholders of Mabwell (Shanghai) Bioscience Co., Ltd.
(Established in the People’s Republic of China with limited liability)

INTRODUCTION
We have reviewed the interim financial information set out on pages 52 to 71, which comprises the condensed
consolidated statement of financial position of Mabwell (Shanghai) Bioscience Co., Ltd. (the “Company”) and
its subsidiaries (the “Group”) as at 30 June 2026 and the related condensed consolidated statements of profit
or loss and other comprehensive income, changes in equity and cash flows for the six-month period then
ended, and explanatory notes. The Rules Governing the Listing of Securities on The Stock Exchange of Hong
Kong Limited require the preparation of a report on interim financial information to be in compliance with the
relevant provisions thereof and Hong Kong Accounting Standard 34 Interim Financial Reporting (“HKAS 34”) as
issued by the Hong Kong Institute of Certified Public Accountants (“HKICPA”). The directors of the Company are
responsible for the preparation and presentation of this interim financial information in accordance with HKAS
34. Our responsibility is to express a conclusion on this interim financial information based on our review. Our
report is made solely to you, as a body, in accordance with our agreed terms of engagement, and for no other
purpose. We do not assume responsibility towards or accept liability to any other person for the contents of this
report.

SCOPE OF REVIEW
We conducted our review in accordance with Hong Kong Standard on Review Engagements 2410 Review of
Interim Financial Information Performed by the Independent Auditor of the Entity as issued by the Hong Kong
Institute of Certified Public Accountants. A review of interim financial information consists of making inquiries,
primarily of persons responsible for financial and accounting matters, and applying analytical and other review
procedures. A review is substantially less in scope than an audit conducted in accordance with Hong Kong
Standards on Auditing and consequently does not enable us to obtain assurance that we would become aware
of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

CONCLUSION
Based on our review, nothing has come to our attention that causes us to believe that the interim financial
information is not prepared, in all material respects, in accordance with HKAS 34.

Ernst & Young
Certified Public Accountants
Hong Kong
30 August 2026

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

52

Interim Condensed Consolidated Statement of
Profit or Loss and Other Comprehensive Income
For the six months ended 30 June 2026

Notes

2026
(Unaudited)
RMB’000

2025
(Unaudited)
RMB’000

312,453
(76,575)

101,098
(22,122)

235,878
11,052
(139,350)
(431,426)
(108,287)
(22,061)
(3,743)
(59,774)
(6,104)

78,976
31,458
(102,207)
(392,091)
(119,033)
(9,978)
3,159
(39,312)
(3,150)

(523,815)
(389)

(552,178)
(54)

(524,204)

(552,232)

(521,707)
(2,497)

(551,321)
(911)

(524,204)

(552,232)

OTHER COMPREHENSIVE LOSS
Exchange differences on translation of foreign operations of group
entities

(1,934)

(42)

OTHER COMPREHENSIVE LOSS FOR THE PERIOD

(1,934)

(42)

TOTAL COMPREHENSIVE LOSS FOR THE PERIOD

(526,138)

(552,274)

Attributable to:
Owners of the parent
Non-controlling interests

(523,641)
(2,497)

(551,363)
(911)

(526,138)

(552,274)

(1.26)

(1.38)

Revenue
Cost of sales

4

Gross profit
Other income and gains
Selling and distribution expenses
Research and development costs
Administrative expenses
Other expenses
(Impairment)/reversal of impairment on financial assets, net
Finance costs
Share of losses of associates
LOSS BEFORE TAX
Income tax expense

5
6

LOSS FOR THE PERIOD
Attributable to:
Owners of the parent
Non-controlling interests

LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS
OF THE PARENT
Basic and diluted (RMB)
– For loss for the period

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

8

53

Interim Condensed Consolidated Statements of Financial Position
30 June 2026

30 June
2026
(Unaudited)
RMB’000

31 December
2025
(Audited)
RMB’000

NON-CURRENT ASSETS
Property, plant and equipment
Right-of-use assets
Goodwill
Other intangible assets
Investments in associates
Prepayments, other receivables and other assets
Financial assets at fair value through profit or loss

1,785,272
217,202
118,770
13,155
87,838
192,372
4,141

1,847,343
259,599
118,770
15,700
91,137
180,653
4,037

Total non-current assets

2,418,750

2,517,239

197,700
128,711
257,772
63,332
2,460
2,226,259

187,897
99,789
222,627
–
1,718
1,526,571

2,876,234

2,038,602

111,831
656,994
247
2,682
1,492,255
29,022
10,288

197,097
680,807
12,935
2,682
1,327,598
34,616
2,869

2,303,319

2,258,604

572,915

(220,002)

2,991,665

2,297,237

Notes

CURRENT ASSETS
Inventories
Trade receivables
Prepayments, other receivables and other assets
Financial assets measured at fair value through profit or loss
Restricted cash
Cash and bank balances

9

Total current assets
CURRENT LIABILITIES
Trade payables
Other payables and accruals
Due to related parties
Derivative financial liabilities
Interest – bearing bank borrowings
Lease liabilities
Corporate bonds
Total current liabilities
NET CURRENT ASSETS/(LIABILITIES)
TOTAL ASSETS LESS CURRENT LIABILITIES

10

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

54
Interim Condensed Consolidated Statements of Financial Position
30 June 2026

30 June
2026
(Unaudited)
RMB’000

31 December
2025
(Audited)
RMB’000

NON-CURRENT LIABILITIES
Other payables and accruals
Interest-bearing bank borrowings
Lease liabilities
Redemption liabilities on non – controlling shares in a subsidiary
Corporate bonds

91,582
1,075,773
77,150
214,300
478,377

102,127
948,030
114,038
207,085
392,955

Total non-current liabilities

1,937,182

1,764,235

Net assets

1,054,483

533,002

446,730
(49,995)
476,750

399,600
(49,995)
(98)

873,485

349,507

180,998

183,495

1,054,483

533,002

Notes

EQUITY
Equity attributable to owners of the parent
Share capital
Treasury shares
Reserves

Non-controlling interests
Total equity

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

11

55

Interim Condensed Consolidated Statement of Changes in Equity
For the six months ended 30 June 2026

Attributable to owners of the parent

At 31 December 2025 (audited)
Loss for the period
Other comprehensive loss for the period
(unaudited):
Exchange differences on translation of
foreign operations of group entities
(unaudited)
Total comprehensive loss for the period
(unaudited)
Net proceeds from Global Offering
(unaudited)
Recognition of share-based payment
expenses (unaudited)
At 30 June 2026 (unaudited)

Share
capital
RMB’000

Treasury
shares
RMB’000

Restricted
shares and
Capital share option
reserve
reserve
RMB’000
RMB’000

399,600
–

(49,995)
–

5,738,533
–

21,517
–

4,454
–

–

–

–

–

–

–

–

47,130

–

–
446,730

Total
RMB’000

Noncontrolling
interests
RMB’000

Total
equity
RMB’000

(5,764,602)
(521,707)

349,507
(521,707)

183,495
(2,497)

533,002
(524,204)

(1,934)

–

(1,934)

–

(1,934)

–

(1,934)

(521,707)

(523,641)

(2,497)

(526,138)

1,000,472

–

–

–

1,047,602

–

1,047,602

–

–

17

–

–

17

–

17

(49,995)

6,739,005

21,534

2,520

(6,286,309)

873,485

180,998

1,054,483

Exchange
fluctuation Accumulated
reserve
losses
RMB’000
RMB’000

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

56
Interim Condensed Consolidated Statement of Changes in Equity
For the six months ended 30 June 2026

Attributable to owners of the parent

Share capital
RMB’000
At 31 December 2024 (audited)
Loss for the period (unaudited)
Other comprehensive loss for the period
(unaudited):
Exchange differences on translation of
foreign operations of group entities
(unaudited)
Total comprehensive loss for the period
(unaudited)
Capital contribution from non-controlling
shareholder (unaudited)
Repurchase obligation to non-controlling
shareholder (unaudited)
Recognition of share-based payment
expenses (unaudited)
At 30 June 2025 (unaudited)

Restricted
shares and
Capital share option
reserve
reserve
RMB’000
RMB’000

Exchange
fluctuation Accumulated
reserve
losses
RMB’000
RMB’000

Total
RMB’000

Noncontrolling
interests
RMB’000

Total
equity
RMB’000

399,600
–

5,938,058
–

21,407
–

5,081
–

(4,795,268)
(551,321)

1,568,878
(551,321)

(13,099)
(911)

1,555,779
(552,232)

–

–

–

(42)

–

(42)

–

(42)

–

–

–

(42)

(551,321)

(551,363)

(911)

(552,274)

–

482

–

–

–

482

199,518

200,000

–

(200,000)

–

–

–

(200,000)

–

(200,000)

–

–

73

–

–

73

–

73

399,600

5,738,540

21,480

5,039

(5,346,589)

818,070

185,508

1,003,578

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

57

Interim Condensed Consolidated Statements of Cash Flows
For the six months ended 30 June 2026

Notes

2026
(Unaudited)
RMB’000

2025
(Unaudited)
RMB’000

(523,815)

(552,178)

59,774
6,104
(5,503)
19
(300)

39,312
3,150
(3,427)
–
–

(55)

(18)

(167)

(57)

(892)
90,928
14,494
2,545
481

(227)
89,515
17,552
2,435
7,690

3,743
17
14,491

(3,159)
73
304

(338,136)
(10,287)
(29,525)

(399,035)
(6,848)
(18,779)

(3,011)
(743)
(85,265)
(47,266)
(189)

5,811
(1,869)
14,740
368,630
108

Cash used in operations
Interest received
Income tax paid

(514,422)
5,438
46

(37,242)
3,481
(162)

Net cash flows used in operating activities

(508,938)

(33,923)

CASH FLOWS FROM OPERATING ACTIVITIES
Loss before tax:
Adjustments for:
Finance costs
Share of losses of associates
Interest income
Loss on disposal of items of property, plant and equipment
Gain on termination of lease
Fair value losses/(gains), net:
Financial assets measured at fair value through profit or loss
Investment income from financial assets measured at
fair value through profit or loss
Investment income from financial assets measured at
amortised cost
Depreciation of property, plant and equipment
Depreciation of right-of-use assets
Amortisation of other intangible assets
Impairment losses of inventories
Impairment losses/(reversal of impairment losses) on trade
receivables and other receivables, net
Share-based payment expenses
Foreign exchange differences, net

Increase in inventories
Increase in trade receivables
(Increase)/decrease in prepayments, other receivables
and other assets
Increase in restricted cash
(Decrease)/increase in trade payables
(Decrease)/increase in other payables and accruals
(Decrease)/increase in amounts due to related parties

5
5
5
5
5
5

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

58
Interim Condensed Consolidated Statements of Cash Flows
For the six months ended 30 June 2026

2026
(Unaudited)
RMB’000

2025
(Unaudited)
RMB’000

CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of items of property, plant and equipment
Purchases of financial assets measured at fair value through profit or loss
Redemption of financial assets measured at fair value through profit or loss
Purchases of financial assets measured at amortised cost
Redemption of financial assets measured at amortised cost
Investment income from financial assets
Investments in associates

(61,586)
(142,094)
78,580
(45,489)
44,792
1,063
(16,000)

(87,210)
(38,106)
41,874
–
–
302
(17,086)

Net cash flows used in investing activities

(140,734)

(100,226)

CASH FLOWS FROM FINANCING ACTIVITIES
New bank loans
Loans from financial institutions
Repayment of borrowings
Interest paid
Proceeds from corporate bonds
Payment of listing and issue expense
Other financing payment
Proceeds from issue of ordinary shares
Capital Contribution from non-controlling shareholders
Finance lease security deposit
Lease payments
Repayment of loans from financial institutions

1,095,302
100,000
(798,730)
(46,589)
85,000
(8,763)
(3,202)
1,095,187
–
(5,000)
(17,231)
(61,473)

867,140
100,000
(792,468)
(41,052)
–
(12,466)
–
–
200,000
–
(13,810)
(11,980)

Net cash flows from financing activities

1,434,501

295,364

NET INCREASE IN CASH AND CASH EQUIVALENTS
Cash and cash equivalents at beginning of period
Effect of foreign exchange rate changes, net

784,829
1,526,339
(17,236)

161,215
1,227,566
(154)

CASH AND CASH EQUIVALENTS AT END OF PERIOD

2,293,932

1,388,627

ANALYSIS OF BALANCES OF CASH AND CASH EQUIVALENTS
Cash and bank balances

2,226,259

1,388,772

Cash and cash equivalents as stated in the interim condensed
consolidated statement of financial position
Interest receivable
Cash equivalents

2,226,259
(296)
67,969

1,388,772
(145)
–

Cash and cash equivalents as stated in the interim condensed
consolidated statement of cash flows

2,293,932

1,388,627

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

59

Notes to Interim Condensed Consolidated Financial Information
30 June 2026

1.

BASIS OF PREPARATION
The interim condensed consolidated financial information for the six months ended 30 June 2026
has been prepared in accordance with HKAS 34 Interim Financial Reporting . The interim condensed
consolidated financial information does not include all the information and disclosures required in the
annual financial statements, and should be read in conjunction with the Group’s annual consolidated
financial statements for the year ended 31 December 2025.

2.

CHANGES IN ACCOUNTING POLICIES
The accounting policies adopted in the preparation of the interim condensed consolidated financial
information are consistent with those applied in the preparation of the Group’s annual consolidated
financial statements for the year ended 31 December 2025, except for the adoption of the following
amended HKFRS Accounting Standards for the first time for the current period’s financial information.
Amendments to HKFRS 9 and HKFRS 7
Amendments to HKFRS 9 and HKFRS 7
Annual Improvements to HKFRS Accounting
Standards – Volume 11

Amendments to the Classification and
Measurement of Financial Instruments
Contracts Referencing Nature-dependent Electricity
Amendments to HKFRS 1, HKFRS 7, HKFRS 9, HKFRS
10 and HKAS 7

The nature and impact of the amended HKFRS Accounting Standards are described below:
(a)

Amendments to HKFRS 9 and HKFRS 7 Amendments to the Classification and Measurement of
Financial Instruments clarify that a financial asset is derecognised when the entity’s rights to the
contractual cash flows expire or are transferred, while a financial liability is derecognised on the
settlement date. The amendments introduce an accounting policy option to derecognise a financial
liability that is settled through an electronic payment system before the settlement date if specified
criteria are met. The amendments clarify how to assess the contractual cash flow characteristics
of financial assets with environmental, social and governance and other similar contingent
features. Moreover, the amendments clarify the requirements for classifying financial assets
with non-recourse features and contractually linked instruments. The amendments also include
additional disclosures for investments in equity instruments designated at fair value through other
comprehensive income and financial instruments with contingent features. Since the Group’s
accounting policy for the derecognition of financial assets and liabilities in prior years aligned
with the amendments and the Group did not have the financial assets that were addressed by the
amendments, the amendments did not have any impact on the interim condensed consolidated
financial information. The Group will provide additional disclosures for its equity investments
designated at fair value through other comprehensive income in the Group’s consolidated financial
statements for the year ending 31 December 2026.

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

60
Notes to Interim Condensed Consolidated Financial Information
30 June 2026

2.

3.

CHANGES IN ACCOUNTING POLICIES (Continued)
(b)

Amendments to HKFRS 9 and HKFRS 7 Contracts Referencing Nature-dependent Electricity clarify
the application of the “own-use” requirements for in-scope contracts and amend the designation
requirements for a hedged item in a cash flow hedging relationship for in-scope contracts. The
amendments also include additional disclosures that enable users of financial statements to
understand the effects these contracts have on an entity’s financial performance and future cash
flows. As the Group did not have any contracts that are in the scope of the amendments, the
amendments did not have any impact on the interim condensed consolidated financial information.

(c)

Annual Improvements to HKFRS Accounting Standards – Volume 11 set out narrow scope
amendments to HKFRS 1, HKFRS 7 (and the accompanying Guidance on implementing HKFRS 7),
HKFRS 9, HKFRS 10 and HKAS 7. The amendments include clarifications, simplifications, corrections
or changes to improve consistency in the corresponding HKFRS Accounting Standards. The
amendments did not have any impact on the interim condensed consolidated financial information.

OPERATING SEGMENT INFORMATION
For management purposes, the Group is not organised into business units based on their services and
only has one reportable operating segment. Management monitors the operating results of the Group’s
operating segment as a whole for the purpose of making decisions about resource allocation and
performance assessment. Since there is only one reportable operating segment of the Group, no further
operating segment analysis thereof is presented.

4.

REVENUE
An analysis of revenue is as follows:
For the six months
ended 30 June

Revenue from contracts with customers

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

2026
RMB’000
(Unaudited)

2025
RMB’000
(Unaudited)

312,453

101,098

61
Notes to Interim Condensed Consolidated Financial Information
30 June 2026

4.

REVENUE (Continued)
Disaggregated revenue information for revenue from contracts with customers
For the six months
ended 30 June
2026
RMB’000
(Unaudited)

2025
RMB’000
(Unaudited)

Types of goods or services
Sale of products
Out-licensing and rendering of services

212,597
99,856

101,004
94

Total

312,453

101,098

Timing of revenue Recognition
Transferred at a point in time

312,453

101,098

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

62
Notes to Interim Condensed Consolidated Financial Information
30 June 2026

5.

LOSS BEFORE TAX
The Group’s loss before tax is arrived at after charging/(crediting):
For the six months
ended 30 June
2026
RMB’000
(Unaudited)

2025
RMB’000
(Unaudited)

Cost of inventories sold
Cost of services provided
Depreciation of property, plant and equipment
Depreciation of right-of-use assets
Amortisation of other intangible assets
Research and development costs
Government grants
Employee benefit expense (including directors’ and
chief executive’s remuneration):
Wages and salaries
Equity-settled share-based payments
Pension scheme contributions

70,530
6,045
90,928
14,494
2,545
431,426
(3,943)

22,034
88
89,515
17,552
2,435
392,091
(25,471)

194,526
17
42,257

175,747
73
40,417

Total

236,800

216,237

3,743
481

(3,159)
7,690

Impairment losses/(reversal of impairment losses) on trade
receivables and other receivables, net
Impairment losses of inventories

Cost of inventories sold and research and development costs include expenses relating to depreciation
of property, plant and equipment, depreciation of right-of-use assets, amortisation of other intangible
assets and employee benefit expense, which are also included in the respective total amounts disclosed
separately above for each of these types of expenses.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

63
Notes to Interim Condensed Consolidated Financial Information
30 June 2026

6.

INCOME TAX
The Group is subject to income tax on an entity basis on profits arising in or derived from the jurisdictions
in which members of the Group are domiciled and operate.
The income tax charge of the Group during the reporting period is analysed as follows:
For the six months
ended 30 June
2026
RMB’000
(Unaudited)

2025
RMB’000
(Unaudited)

Current tax:
Charge for the period

389

54

Total tax charge for the period

389

54

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

64
Notes to Interim Condensed Consolidated Financial Information
30 June 2026

7.

DIVIDENDS
No dividend was paid or declared by the Company during the reporting period (2025: nil).

8.

LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE
PARENT
The calculation of the basic loss per share amount is based on the loss for the period attributable
to ordinary equity holders of the parent, and the weighted average number of ordinary shares of
415,072,000 (2025: 399,600,000) outstanding during the period.
The weighted average number of ordinary shares used in the calculation is the number of ordinary shares
outstanding during the period, as used in the basic earnings per share calculation.
The Group had no potentially dilutive ordinary shares outstanding during the periods ended 30 June 2026
and 2025.
The calculation of basic and diluted loss per share are based on:
For the six months
ended 30 June
2026
RMB’000
(Unaudited)

2025
RMB’000
(Unaudited)

Loss
Loss attributable to ordinary equity holders of the parent,
used in the basic and diluted loss per share calculation (RMB’000)

(521,707)

(551,321)

Shares (’000)
Weighted average number of ordinary shares outstanding during
the period used in the basic loss per share calculation

415,072

399,600

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

65
Notes to Interim Condensed Consolidated Financial Information
30 June 2026

9.

TRADE RECEIVABLES
An ageing analysis of the trade receivables as at the end of the reporting period, based on the invoice
date and net of loss allowance, is as follows:

Within 1 year

30 June
2026
RMB’000
(Unaudited)

31 December
2025
RMB’000
(Audited)

128,711

99,789

10. TRADE PAYABLES
An ageing analysis of the trade payables as at the end of the reporting period, based on the invoice date,
is as follows:

Within 1 year

30 June
2026
RMB’000
(Unaudited)

31 December
2025
RMB’000
(Audited)

111,831

197,097

Trade payables are non-interest-bearing and are normally settled on terms of 30 to 180 days.

11. SHARE CAPITAL
During the period, the Company issued 47,130,200 ordinary shares with a par value of RMB1.00 each
as a result of its listing on the Stock Exchange of Hong Kong Limited. Consequently, the total number of
ordinary shares in issue increased from 399,600,000 as at 31 December 2025 to 446,730,200 as at 30 June
2026.

12. COMMITMENTS
30 June
2026
RMB’000
(Unaudited)

31 December
2025
RMB’000
(Audited)

Contracted, but not provided for:
Property, plant and equipment
Investment in associates

101,205
4,000

182,914
7,500

Total

105,205

190,414

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

66
Notes to Interim Condensed Consolidated Financial Information
30 June 2026

13. RELATED PARTY TRANSACTIONS
(a)

The Group had the following transactions with related parties during the
period:
For the six months
ended 30 June

Notes

Purchases of services
Intellective Bio
Shilang

Total

182
522

–
569

704

569

–

121

–

121

6,756
–

6,804
202

6,756

7,006

(ii)

Total
Lease payment
Shilang
Gefeimu

2025
RMB’000
(Unaudited)

(i)

Total
Purchases of equipment
Qingxuan

2026
RMB’000
(Unaudited)

(iii)

Notes:
(i)

The purchases of services include receiving services for electricity services and technical services were made
according to the prices and terms offered by the related parties with reference to the market price.

(ii)

The purchases of equipment were made according to the prices and terms offered by the related parties with
reference to the market price, used for research and development activities.

(iii)

The leases include the buildings rented were made according to the prices and terms offered by the related parties
with reference to the market price for offices and laboratories use.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

67
Notes to Interim Condensed Consolidated Financial Information
30 June 2026

13. RELATED PARTY TRANSACTIONS (continued)
(b)

Outstanding balances with related parties:
30 June
2026
RMB’000
(Unaudited)

31 December
2025
RMB’000
(Audited)

Lease liabilities – current
Shilang

12,097

11,637

Lease liabilities – non current
Shilang

40,138

46,993

Due to related parties – current (trading nature)
Sinusai
Shilang
Qingrun

–
247
–

12,500
152
283

Total

247

12,935

All trading nature outstanding balances with related parties are unsecured and non-interestbearing.

(c)

Compensation of the key management personnel of the Group
For the six months
ended 30 June
2026
RMB’000
(Unaudited)

2025
RMB’000
(Unaudited)

Salaries, bonuses and allowances
Pension scheme contributions and social welfare

19,507
1,048

11,612
1,010

Total compensation paid to key management personnel

20,555

12,622

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

68
Notes to Interim Condensed Consolidated Financial Information
30 June 2026

14. FAIR VALUE AND FAIR VALUE HIERARCHY OF FINANCIAL INSTRUMENTS
Management has assessed that the fair values of cash and bank balances, restricted cash, trade
receivables, financial assets included in prepayments, other receivables and other assets (in the current
portion), trade payables, financial liabilities included in other payables and accruals, interest-bearing bank
borrowings and due to related parties approximate to their carrying amounts largely due to the shortterm maturities of these instruments.
The Group’s finance department headed by the finance manager is responsible for determining the
policies and procedures for the fair value measurement of financial instruments. At the end of each of
reporting date, the finance department analyses the movements in the values of financial instruments
and determines the major inputs applied in the valuation. The directors review the results of the fair
value measurement of financial instruments periodically for financial reporting.
The fair values of the financial assets and liabilities are included at the amount at which the instrument
could be exchanged in a current transaction between willing parties, other than in a forced or liquidation
sale. The following methods and assumptions were used to estimate the fair values:
The fair values of the non-current portion of financial assets included in prepayments, other receivables
and other assets have been calculated by discounting the expected future cash flows using rates
currently available for instruments with similar terms, credit risk and remaining maturities.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

69
Notes to Interim Condensed Consolidated Financial Information
30 June 2026

14. FAIR VALUE AND FAIR VALUE HIERARCHY OF FINANCIAL INSTRUMENTS
(continued)
Set out below is a summary of significant unobservable inputs to the valuation of financial instruments
together with a quantitative sensitivity analysis as at 30 June 2026 and 31 December 2025:

As at 30 June 2026 and 31 December 2025
Financial
liabilities/assets
Derivative
Financial
Liabilities

Fair
value
hierarchy
Level 3

Valuation Unobservable
technique
inputs
Binomial
model

Risk-free
interest rate

Volatility

Probability of
exercise
Financial assets
measured at fair
value through
profit or loss

Level 3

Market
approach
and income
approach

Risk-free
interest rate

Volatility

Probability of
exercise

Sensitivity of
unobservable
inputs to fair value
1% increase/decrease
would result in
decrease/increase in fair
value by 0.1%
1% increase/decrease
would result in
increase/decrease in fair
value by 0.8%
1% increase/decrease
would result in increase/
decrease in fair value by 1%
1% increase/decrease
would result in decrease/
increase in fair value by 0.1%
1% increase/decrease would
result in increase/decrease
in fair value by 0.1%
1% increase/decrease would
result in increase/decrease
in fair value by 9%

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

70
Notes to Interim Condensed Consolidated Financial Information
30 June 2026

14. FAIR VALUE AND FAIR VALUE HIERARCHY OF FINANCIAL INSTRUMENTS
(continued)

Fair value hierarchy
The following tables illustrate the fair value measurement hierarchy of the Group’s financial instruments:
Assets measured at fair value:
Fair value measurement using
Quoted
prices
in active
markets
(Level 1)
RMB’000
As at 30 June 2026
Financial assets measured at fair
value through profit or loss

–

Significant
Significant
observable unobservable
inputs
inputs
(Level 2)
(Level 3)
RMB’000
RMB’000

63,332

Total
RMB’000

4,141

67,473

Fair value measurement using

As at 31 December 2025
Financial assets measured at fair
value through profit or loss

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

Quoted
prices
in active
markets
(Level 1)
RMB’000

Significant
observable
inputs
(Level 2)
RMB’000

Significant
unobservable
inputs
(Level 3)
RMB’000

Total
RMB’000

–

–

4,037

4,037

71
Notes to Interim Condensed Consolidated Financial Information
30 June 2026

14. FAIR VALUE AND FAIR VALUE HIERARCHY OF FINANCIAL INSTRUMENTS
(continued)

Fair value hierarchy (continued)
Liabilities measured at fair value:
Fair value measurement using
Quoted
prices
in active
markets
(Level 1)
RMB’000
As at 30 June 2026
Derivative financial liabilities

–

Significant
Significant
observable unobservable
inputs
inputs
(Level 2)
(Level 3)
RMB’000
RMB’000

–

Total
RMB’000

2,682

2,682

Fair value measurement using

As at 31 December 2025
Derivative financial liabilities

Quoted
prices
in active
markets
(Level 1)
RMB’000

Significant
observable
inputs
(Level 2)
RMB’000

Significant
unobservable
inputs
(Level 3)
RMB’000

Total
RMB’000

–

–

2,682

2,682

15. EVENTS AFTER THE REPORTING PERIOD
There were no material subsequent events undertaken by the Group after 30 June 2026.

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

72

Forward-Looking Statements

All statements in this report that are not historical fact or that do not relate to present facts or current
conditions are forward-looking statements. Such forward-looking statements express the Group’s current views,
projections, beliefs and expectations with respect to future events as of the Latest Practicable Date. Such
forward-looking statements are based on a number of assumptions and factors beyond the Group’s control. As
a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially
from these forward-looking statements and the forward-looking events discussed in this report might not
occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading “Principal
Risks and Uncertainties” in this interim report and in the section headed “Risk Factors” in our Prospectus made
available on our corporate website, http://www.mabwell.com. No representation or warranty is given as to the
achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or
forecasts contained in this report.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

73

Definitions

“A Share(s)”

ordinary share(s) issued by our Company, with a nominal value of
RMB1.00 each, which is/are subscribed for or credited as paid in
Renminbi and is/are listed for trading on the Shanghai Stock Exchange
STAR Market

“A Shareholder(s)”

holder(s) of the A Share(s)

“A Share Offering”

initial public offering of 99,900,000 A Shares of the Company which
are listed for trading on the Shanghai Stock Exchange STAR Market on
January 18, 2022

“A Share Prospectus”

the prospectus in relation to the A Share Offering published on January
10, 2022

“affiliate”

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

“Articles of Association” or
“Articles”

the articles of association of our Company, as amended, which shall
become effective on the Listing Date

“associate(s)”

has the meaning ascribed to it under the Listing Rules

“Audit Committee”

the audit committee of the Company

“Board of Directors”, “Board” or
“our Board”

the board of Directors

“CDE”

Center for Drug Evaluation (藥品審評中心) under the NMPA

“China” or “PRC”

unless the context requires otherwise, and for the purpose of this
report only, shall have the same meaning as Chinese Mainland

“Chinese Mainland” or “Mainland”

the Mainland of People’s Republic of China, namely, excluding the
regions of Hong Kong, Macau and Taiwan of the People’s Republic of
China

“Company”, “our Company”, and
“the Company”

Mabwell (Shanghai) Bioscience Co., Ltd. (邁威(上海)生物科技股份有限公
司), a limited liability company incorporated in the PRC on May 12, 2017
and converted from our predecessor Mabwell (Shanghai) Bioscience
Ltd. (邁威(上海)生物科技有限公司) into a joint stock company with
limited liability under the PRC Company Law on June 30, 2020, the
A Shares of which are listed on the Shanghai Stock Exchange STAR
Market (stock code: 688062)

“Controlling Shareholder(s)”

has the meaning ascribed thereto under the Listing Rules, and unless
the context otherwise requires, refers to Mr. Tang Chunshan, Ms. Chen
Shanna, Langrun Equity, Zhongjun Jianlong, Zhenzhu Investment and
Langrun Investment Consultancy

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

74
Definitions

“Core Product”

has the meaning ascribed thereto under Chapter 18A of the Listing
Rules and is the product for the purpose of satisfying the eligibility
requirements under Chapter 18A of the Listing Rules and in this
context, refers to 9MW2821

“Corporate Governance Code”

the Corporate Governance Code set out in Appendix C1 to the Listing
Rules

“Director(s)”

the director(s) of the Company

“Eligible Participants”

has the meaning ascribed to it under the paragraph headed “XV. SHARE
INCENTIVE SCHEMES – Pre-IPO Equity Incentive Plan – Purpose” in this
report

“Employee Incentive Platforms”

Zhenzhu Investment and Zhongjun Jianlong

“ESG Committee”

the environmental, social and governance (ESG) committee of the
Board

“FDA”

U.S. Food and Drug Administration

“Global Offering”

the initial public offering of the shares on the terms and subject to the
conditions as described in the Prospectus

“Group”, “our Group”, “we”, “us”
or “our”

our Company and its subsidiaries

“H Share(s)”

listed ordinary share(s) in the share capital of our Company with a
nominal value of RMB1.00 each, which is/are to be subscribed for and
traded in HK dollars and listed on the Hong Kong Stock Exchange

“HK$” or “Hong Kong Dollars” or
“HK Dollars”

Hong Kong dollars, the lawful currency of Hong Kong

“Hong Kong” or “HK”

the Hong Kong Special Administrative Region of the People’s Republic
of China

“Hong Kong Stock Exchange” or
“Stock Exchange”

The Stock Exchange of Hong Kong Limited, a wholly-owned subsidiary
of Hong Kong Exchange and Clearing Limited

“IPO”

initial public offering

“Langrun Equity”

Langrun (Shenzhen) Equity Investment Fund Enterprise (Limited
Partnership)* (朗潤(深圳)股權投資基金企業(有限合夥)), a limited
partnership established in the PRC on December 2, 2015 (of which
Langrun Investment Consultancy is the sole general partner) and a
Controlling Shareholder

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

75
Definitions

“Langrun Investment Consultancy”

Shenzhen Langrun Investment Consultancy Management Co., Ltd.* (深
圳市朗潤投資諮詢管理有限公司), a limited liability company established
in the PRC on November 17, 2015 and a Controlling Shareholder

“Langrun Mabwell”

Shanghai Langrun Mabwell Biomedical Technology Co., Ltd.* (上海朗潤
邁威生物醫藥科技有限公司), a limited liability company incorporated in
the PRC on May 31, 2017 and a directly wholly-owned subsidiary of our
Company

“Latest Practicable Date”

August 30, 2026, being the latest practicable date prior to the printing
of this report for the purpose of ascertaining certain information
contained in this report

“Listing”

the listing of our H Shares on the Main Board

“Listing Date”

April 28, 2026

“Listing Rules”

the Rules Governing the Listing of Securities on The Stock Exchange of
Hong Kong Limited, as amended, supplemented or otherwise modified
from time to time

“Main Board”

the stock exchange (excluding the option market) operated by the
Hong Kong Stock Exchange which is independent from and operated in
parallel with the GEM of the Hong Kong Stock Exchange

“Model Code”

Model Code for Securities Transactions by Directors of Listed Issuers
set out in Appendix C3 to the Listing Rules

“NMPA”

the National Medical Products Administration of China (國家藥品監督
管理局) or, where the context so requires, its predecessor, the China
Food and Drug Administration (國家食品藥品監督管理總局), or CFDA

“NPC”

the National People’s Congress of the PRC (中華人民共和國全國人民代
表大會)

“Nomination Committee”

the nomination committee of the Company

“Pre-IPO Equity Incentive Plan”

the pre-IPO equity incentive plan of our Company approved and
adopted on June 19, 2020 (as amended on December 31, 2024 by
Shareholders’ resolutions of the Company), as amended from time
to time, a summary of the principal terms of which is set forth in
paragraph headed “XV. SHARE INCENTIVE SCHEMES – Pre-IPO Equity
Incentive Plan” in this report

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

76
Definitions

“Prospectus”

the prospectus issued by the Company on April 20, 2026 in connection
with the Global Offering

“Remuneration and Appraisal
Committee”

the remuneration and appraisal committee of the Company

“Reporting Period”

the period from January 1, 2026 to June 30, 2026

“RMB”

Renminbi, the lawful currency of China

“SFC”

the Securities and Futures Commission of Hong Kong

“SFO”

the Securities and Futures Ordinance (Cap. 571), as amended,
supplemented or otherwise modified from time to time

“Shanghai Stock Exchange”

the Shanghai Stock Exchange (上海證券交易所)

“Shanghai Stock Exchange STAR
Market”

the Sci-tech Innovation Board of the Shanghai Stock Exchange

“Share(s)”

ordinary share(s) in the capital of our Company with a nominal value of
RMB1.00 each

“Shareholder(s)”

holder(s) of Shares of the Company

“Strategy Committee”

the strategy committee of the Company

“Stock Exchange”

The Stock Exchange of Hong Kong Limited

“subsidiary(ies)”

has the meaning ascribed to it in section 15 of the Companies
Ordinance

“United States” or “U.S.”

the United States of America, its territories, its possessions and all
areas subject to its jurisdiction

“US$” or “U.S. Dollars”

United States dollars, the lawful currency of the United States

“Zhenzhu Investment”

Ningbo Meishan Free Trade Port Zhenzhu Investment Management
Partnership (Limited Partnership)* (寧波梅山保稅港區真珠投資管理
合夥企業(有限合夥)), a limited partnership established in the PRC on
January 16, 2018 (of which Mr. Tang is the sole general partner), also a
Controlling Shareholder and one of the Employee Incentive Platforms

“Zhongjun Jianlong”

Ningbo Meishan Free Trade Port Zhongjun Jianlong Investment
Partnership (Limited Partnership)* (寧波梅山保稅港區中駿建隆投資
合夥企業(有限合夥)), a limited partnership established in the PRC on
November 2, 2017 (of which Mr. Tang is the sole general partner), also
a Controlling Shareholder and one of the Employee Incentive Platforms

“%”

per cent

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

77

Glossary

“ADC”

antibody-drug conjugate, a class of drugs that combine monoclonal
antibodies specific to surface antigens present on particular tumor
cells with highly potent antitumor small molecule agents linked via a
chemical linker

“AMD”

age-related macular degeneration, a disease that affects the middle
part of your vision

“AML”

acute myeloid leukemia

“antibody”

also known as an immunoglobulin, a protein used by the immune
system to recognize and bind an antigen

“APS”

aseptic Process Simulation or media fill

“ASCO”

American Society of Clinical Oncology

“BCVA”

best-corrected visual acuity

“BFv”

bulumtatug fuvedotin

“BTD”

breakthrough therapy designation, a process designed to expedite the
development and review of drugs that are intended to treat a serious
condition

“CC”

cervical cancer, a type of cancer that occurs in the cells of the cervix

“CD”

cluster of differentiation

“CDH17”

cadherin-17

“chemotherapy”

a category of cancer treatment that uses one or more anti-cancer
chemotherapeutic agents as part of its standardized regimen

“clinical trial/study”

a research study carried out in human for validating or finding the
therapeutic effects and side effects of test drugs in order to determine
their therapeutic value and safety

“CMC”

Chemistry, Manufacturing & Controls

“CMML”

chronic myelomonocytic leukemia

“CMO”

contract manufacturing organization, a company that serves other
companies in the pharmaceutical industry on a contract basis to
provide comprehensive services from drug development through drug
manufacturing

“COPD”

chronic obstructive pulmonary disease

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

78
Glossary

“CRT”

central retinal thickness

“DAR”

drug-to-antibody ratio, the number of drugs conjugated to the antibody

“DME”

diabetic macular edema, an eye disease that occurs in diabetic
patients, characterized by retinal thickening caused by the
accumulation of intraretinal fluid

“EC”

esophageal cancer, a disease in which malignant cancer cells form in
the tissues of the esophagus

“ESMO”

European Society for Medical Oncology

“Fc”

fragment crystallizable

“FTD”

fast track designation

“G-CSF”

granulocyte colony stimulating factor

“GMP”

good manufacturing practice, the practices required in order to
conform to the guidelines recommended by agencies that control the
authorization and licensing of the manufacture and sale of products

“HSA”

human serum albumin

“IBD”

inflammatory bowel disease

“IDDC”

interchain-disulfide drug conjugate

“IL-33”

interleukin-33

“indication”

a valid reason to use a specific test, drug, device, procedure or surgery

“investigator-choice chemotherapy”

chemotherapy treatment plans chosen by clinical trial investigators

“IND”

investigational new drug, the application for which is the first step in
the drug review process by regulatory authorities to decide whether to
permit clinical trials; also known as clinical trial application in China

“IO”

immunotherapy

“ITIM”

immunoreceptor tyrosine-based inhibitory motif

“metastatic”

in reference to any disease, including cancer, disease producing
organisms or of malignant or cancerous cells transferred to other parts
of the body by way of the blood or lymphatic vessels or membranous
surfaces

“MM”

multiple myeloma

“MS”

multiple sclerosis

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

79
Glossary

“NDA”

new drug application, a process required by a regulatory authority to
approve a new drug for sale and marketing

“Nectin-4”

Nectin cell adhesion molecule 4, a type I transmembrane protein
of the Nectin family, functioning as a cell adhesion molecule and
overexpressed in various tumor types

“ODD”

orphan drug designation

“PBC”

primary biliary cholangitis

“PCC”

preclinical candidate compound

“PD”

pharmacodynamics, the branch of pharmacology concerned with the
effects of drugs and the mechanism of their action

“PD-1”

programmed cell death protein 1, an immune checkpoint receptor
expressed on T cells, B cells and macrophages, acting to turn off the
T cell mediated immune response as part of the process that stops a
healthy immune system from attacking other pathogenic cells in the
body

“Phase I clinical trial(s)”

study in which a drug is introduced into healthy human subjects or
patients with the target disease or condition and tested for safety,
dosage tolerance, absorption, metabolism, distribution, excretion, and
if possible, an early indication of its effectiveness

“Phase Ia clinical trial(s)”

study in which single ascending doses are tested on the healthy human
subjects or patients to primarily assess safety, dosage tolerance, and
PK/PD at different dose levels

“Phase Ib clinical trial(s)”

study in which multiple ascending doses are tested on the healthy
human subjects or patients to primarily assess safety, dosage tolerance
and PK/PD at different dose levels prior to commencement of Phase II
or Phase III clinical trial

“Phase II clinical trial(s)”

study in which a drug is administered to a limited patient population
to identify possible adverse effects and safety risks, to preliminarily
evaluate the efficacy of the product for specific targeted diseases, and
to determine dosage tolerance and optimal dosage

“Phase III clinical trial(s)”

study in which a drug is administered to an expanded patient
population generally at geographically dispersed clinical trial sites, in
well-controlled clinical trials to generate enough data to statistically
evaluate the efficacy and safety of the product for approval, to provide
adequate information for the labeling of the product

“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

Interim Report 2026 Mabwell (Shanghai) Bioscience Co., Ltd.

80
Glossary

“platinum-based chemotherapy”

a group of drugs containing platinum compounds, an established
chemotherapy treatment for various cancers by targeting rapidly
dividing cancer cells and interfering with their DNA, leading to cell
death

“preclinical studies”

studies testing a drug on non-human subjects, to gather efficacy,
toxicity, pharmacokinetic and safety information and to decide whether
the drug is ready for clinical trials

“QP”

Qualified Person

“R&D”

research and development

“RANKL”

receptor activator of nuclear factor kappa-B ligand

“rheumatoid arthritis”

an inflammatory autoimmune disorder that primarily affects the joints

“RVO”

retinal vein occlusion

“T1DM”

type 1 diabetes mellitus

“TAA”

tumor-associated antigens

“TCE”

T-cell engager

“TEAEs”

treatment-emergent adverse events

“TMPRSS6”

transmembrane protease serine 6

“TNBC”

triple-negative breast cancer, a breast cancer that tests negative for
estrogen receptors, progesterone receptors, and excess HER2 protein

“TNF-α”

tumor necrosis factor-α, a cytokine that plays a central role in
inflammation and immune responses

“toripalimab”

a PD-1 antibody drug for the treatment of indications including multiple
solid tumors, developed by Shanghai Junshi Biosciences Co., Ltd.

“UC”

urothelial cancer, a type of cancer that typically occurs in the urinary
system

“VEGF”

vascular endothelial growth factor

“WOC”

World Ophthalmology Congress

In the case of inconsistency, the English text of this report shall prevail over the Chinese text.

Mabwell (Shanghai) Bioscience Co., Ltd. Interim Report 2026

邁威（上海）生物科技股份有限公司
Mabwell (Shanghai) Bioscience Co., Ltd.

（於中華人民共和國註冊成立的股份有限公司）

股份代號 : 2493

2026
中 期 報 告

目錄
2

公司資料

53

中期簡明綜合財務狀況表

4

業務概況

55

中期簡明綜合權益變動表

6

財務概況

57

中期簡明綜合現金流量表

7

管理層討論及分析

59

中期簡明綜合財務資料附註

40

企業管治及其他資料

72

前瞻性陳述

51

獨立審閱報告

73

釋義

52

中期簡明綜合損益及其他全面收益表

77

詞彙表

2

公司資料

董事會

聯席公司秘書

執行董事

王鶴飛女士
梁君慧女士

唐春山先生
劉大濤博士（董事長）
武海博士
華俊先生
桂勛博士

獨立非執行董事
秦正余先生
周睿先生
李凡女士
王芳女士

授權代表
華俊先生
梁君慧女士

審計委員會
秦正余先生（主席）
周睿先生
李凡女士

中國註冊辦事處、總部及主要營業地點

薪酬與考核委員會

中國上海市
中國（上海）自由貿易試驗區
蔡倫路230號
2幢105室
H股郵箱: irhk@mabwell.com
A股郵箱: ir@mabwell.com

劉大濤博士
李凡女士（主席）
周睿先生

香港主要營業地點
香港銅鑼灣
希慎道33號
利園一期19樓1928室

有關香港法律的法律顧問
Davis Polk & Wardwell
香港
中環
遮打道三A號
香港會所大廈十樓

提名委員會
劉大濤博士
周睿先生（主席）
李凡女士

戰略委員會
唐春山先生
劉大濤博士（主席）
武海博士

ESG委員會
劉大濤博士（主席）
華俊先生
李凡女士

2026年中報

邁威（上海）生物科技股份有限公司

3
公司資料

H股證券登記處

公司網站

卓佳證券登記有限公司
香港
夏愨道16號
遠東金融中心17樓

http://www.mabwell.com

合規顧問
新百利融資有限公司
香港
皇后大道中29號
華人行20樓

股份代號
H股聯交所：2493
A股證券交易所：688062

主要往來銀行

核數師
安永會計師事務所
執業會計師
《會計及財務匯報局條例》定義之
註冊公眾利益實體核數師
香港
鰂魚涌英皇道979號
太古坊一座27樓

邁威（上海）生物科技股份有限公司

2026年中報

上海浦東發展銀行（上海虹橋支行）
中國上海市長寧區
興義路8號
萬都商城1樓

4

業務概況

截至最後實際可行日期，我們以市場需求大且針對成熟靶點的生物類似藥，及存在巨大臨床應用未得到滿足的創新
藥為起點，完成了臨床前研究到商業化生產乃至銷售的完整產業鏈佈局，已實現如下成就及里程碑事件：
•

公司始終將創新研發作為核心發展戰略，構建了以抗體藥物靶點驗證與分子發現為起點的全週期創新體系，
擁有抗體偶聯（「ADC」）藥物開發平台、一體化高效抗體發現平台和TCE雙 ╱ 三特異性抗體開發平台三大特色
技術平台。公司擁有15個處於臨床研究或上市階段的重點品種，包括11個創新藥，4個生物類似藥，專注於
腫瘤和年齡相關疾病，如免疫、眼科、骨科等領域。其中，已上市品種4個，境內生產藥品註冊上市許可申請
審評階段的品種1個，處於III期關鍵註冊臨床階段品種2個，以及處於其他不同臨床研究階段的品種。核心產
品9MW2821已進入關鍵臨床階段，並獲得多項突破性療法認定（「BTD」）。目前四項III期關鍵性註冊臨床正在
開展，其中尿路上皮癌（「UC」）單藥及聯合療法、宮頸癌（「CC」）單藥療法的III期臨床計劃於2026年進行期中
分析，有望據此分析結果提交新藥上市申請前會議。此外，三陰性乳腺癌（「TNBC」）
（拓撲異構酶ADC經治單
藥）的III期臨床及美國Ib期臨床也在積極推進中。
－

2026年1月，7MW4911用於晚期結直腸癌及其他晚期胃腸道腫瘤適應症的臨床試驗在美國完成首例患
者給藥。

－

2026年2月，9MW2821完成治療含鉑化療失敗的復發或轉移性宮頸癌的III期臨床研究的所有受試者入
組。

－

7MW3711完成聯合JS207（PD-1/VEGF雙抗）聯合或不聯合鉑類化療（順鉑或卡鉑）用於晚期實體瘤的Ib/
II期臨床試驗的首例受試者入組。

－

2026年3月，9MW3011完成題為「治療中國真性紅細胞增多症患者的多中心、隨機、開放標籤、多次
給藥劑量遞增的安全性、耐受性、藥代動力學、藥效學和免疫原性的Ib期臨床研究」的所有受試者入
組。

－

9MW0311題為「地舒單抗對2型糖尿病骨質疏鬆性骨折高風險患者的干預效果研究（CODE-DO Study）」
完成首例受試者入組。

－

2026年4月，1MW5011題為「評估試驗藥物1MW5011（ 原代號RP901）片劑多次給藥在膝骨關節炎患者
的安全性、耐受性、藥代動力學、藥效動力學特徵的多中心、隨機、陽性對照及安慰劑平行對照Ib期
臨床研究」完成所有受試者入組。

2026年中報

邁威（上海）生物科技股份有限公司

5
業務概況

•

－

2026年5月，9MW2821治療經鉑類化療和PD-(L)1抑制劑治療的局部晚期或轉移性尿路上皮癌的III期臨
床研究的所有受試者入組，治療局部晚期或轉移性三陰性乳腺癌的III期臨床試驗首例患者入組。

－

9MW5211用於炎症性腸病患者的臨床試驗（「IND」）申請獲得FDA許可。

－

9MW0321用於實體腫瘤骨轉移患者和多發性骨髓瘤患者的治療，以延遲或降低骨相關事件（病理性骨
折、脊髓壓迫、骨放療、骨手術）的發生風險的補充申請獲得批准。

－

2026 年6 月，9MW5211 用於炎症性腸病、多發性硬化的IND申請分別獲得國家藥品監督管理局
（「NMPA」）批准。

－

6MW5311用於血液系統惡性腫瘤（急性髓系白血病、慢性粒單核細胞白血病以及多發性骨髓瘤）患者
的IND申請先後獲得FDA許可和NMPA批准。

－

9MW1911用於慢性阻塞性肺疾病患者的有效性、安全性的多中心、隨機、雙盲、安慰劑平行對照的Ⅱ
期臨床研究完成所有受試者入組。

－

2026 年 7 月，9MW5211 用於1 型糖尿病、白癜風和原發性膽汁性膽管炎適應症的 IND 申請先後獲得
NMPA批准。

－

君邁康 ®（阿達木單抗注射液）被納入新版《國家基本藥物目錄（2026年版）》。

關於公司運營
－

2026年4月，本公司完成根據一般授權配售新H股，按每股H股27.64港元成功配發及發行合計4,713.02
萬股H股，募集資金淨額（經扣除佣金及估計開支後）約為1,197.1百萬港元，將用於創新藥研發和補充
營運資金等一般企業用途。

邁威（上海）生物科技股份有限公司

2026年中報

6

財務概況

經營業績
截至6月30日止六個月
2026年
人民幣千元
（未經審核）

2025年
人民幣千元
（未經審核）

312,453
(524,204)
(1.26)

101,098
(552,232)
(1.38)

於2026年
6月30日
人民幣千元
（未經審核）

於2025年
12月31日
人民幣千元
（經審核）

2,418,750
2,876,234
5,294,984
1,937,182
2,303,319
4,240,501
1,054,483

2,517,239
2,038,602
4,555,841
1,764,235
2,258,604
4,022,839
533,002

收入
期內虧損
每股虧損 － 基本及攤薄（人民幣元）

財務狀況

非流動資產
流動資產
總資產
非流動負債
流動負債
負債總額
總權益

2026年中報

邁威（上海）生物科技股份有限公司

7

管理層討論及分析

I.

概覽
我們成立於2017年，是一家以藥物研發方面的創新能力以及從藥物發現至商業化銷售的端到端能力而聞名的
中國製藥公司。本公司A股自2022年1月起於上海證券交易所科創板上市（證券代碼：688062），H股自2026
年4月起於香港聯合交易所有限公司（「香港聯交所」或「聯交所」）主板上市（股份代號：2493）。本公司共有15
個重點品種處於臨床研究或上市階段，涵蓋11款創新藥與4款生物類似藥，重點佈局腫瘤、衰老相關疾病，
如免疫、眼科、骨科等領域。其中，4個品種已獲批上市，1個品種的國產藥品註冊上市許可申請處於審評階
段，2個品種處於III期關鍵註冊臨床試驗階段，其餘品種分別處於不同臨床研究階段。
截至最後實際可行日期，在國內開發的所有靶向Nectin-4的ADC藥物中，9MW2821針對UC適應症的臨床開
發階段最為領先，臨床進度僅次於Padcev。9MW2821亦是全球首個進入CC適應症關鍵III期臨床試驗的靶向
Nectin-4的ADC藥物。本公司目前正在針對UC、CC、TNBC及食管癌（「EC」）開展多項9MW2821臨床試驗，
包括(i)分別作為單藥療法及聯合特瑞普利單治療UC的III期臨床試驗；(ii)作為單藥療法治療CC的III期臨床試
驗；(iii)作為單藥療法治療TNBC的III期臨床試驗；及(iv)其他多項I/II臨床正在快速開展。

II.

業務回顧
我們的產品及產品管線
我們主要專注於自主開發腫瘤和年齡相關疾病藥物，涉及免疫、眼科、骨科等領域，該等疾病在全球構成重
大健康風險且存在未被滿足的臨床需求。我們的管線產品組合包括創新候選藥物（包括ADC及其他品種）及已
上市藥物。

邁威（上海）生物科技股份有限公司

2026年中報

8
管理層討論及分析

下圖概述截至最後實際可行日期我們管線產品的開發情況。
產品

9MW2821

靶點

Nectin-4
ADC

自主/
外部

自主研發

臨床試驗
臨床前
區域

適應症

7MW3711

B7- H3
ADC

自主研發

I期

II期

III期

NDA

上市

「 IND/NDA 」
申請/ 獲批編號

當前狀態/
下一個里程碑

中國

中國藥監局

BTD

2021LP01688

III期試驗階段；
2024年8月獲中國藥監局授予BTD；
預計2026年下半年進行中期分析並提交pre-NDA

中國

中國藥監局

BTD

2023LP00633

III期試驗階段；
2025年1月獲中國藥監局授予BTD；
預計2026年下半年進行中期分析並提交pre-NDA

尿路上皮癌
（圍手術期聯合特瑞普利單抗）

中國

中國藥監局

2024LP02554

II期試驗階段；
2024年11月IND獲批准

三陰性乳腺癌
（拓撲異構酶ADC經治單藥）

中國

中國藥監局

2024LP01576

III期試驗階段

三陰性乳腺癌
（拓撲異構酶ADC經治單藥）

美國

FDA

FTD

IND 161043

Ib期試驗階段（劑量優化橋接研究）；
2025年3月IND獲批准；
2024年7月獲FDA授予FTD

三陰性乳腺癌
（一線聯合特瑞普利單抗）

中國

中國藥監局

2024LP01576

II期試驗階段

宮頸癌（二三線單藥）

中國

中國藥監局

FTD

2021LP01688

III期試驗階段；
2024年5月獲FDA授予FTD；
預計2026年下半年進行中期分析並提交preNDA

婦科腫瘤（包括宮頸癌）
（一線聯合其他抗腫瘤療法）

中國

中國藥監局

2024LP02507

Ib/II期試驗階段；
2024年11月IND獲批准

食管癌（二線及以後單藥）

中國

中國藥監局

2021LP01688

II期試驗階段；
2024年2月獲FDA授予FTD；
2024年8月獲FDA授予ODD
Ib/II期試驗階段；
2024年11月IND獲批准

尿路上皮癌
（二線及以後單藥）
尿路上皮癌
（一線聯合特瑞普利單抗）

晚期實體瘤
（包括食管癌）
（一線聯合其他抗腫瘤療法）
尿路上皮癌
（一線單藥或聯合特瑞普利單抗）

腫瘤

IND

FTD

ODD

中國

中國藥監局

2024LP02507

中國

中國藥監局

2021LP01688

II期試驗階段

肺癌（（二線及以後單藥）

中國

中國藥監局

2023LP01409

I/II期試驗階段；
2024年7月獲FDA授予ODD;
預計2027年上半年完成I/II期試驗

晚期實體瘤聯合特瑞普利單抗
（聯合或不聯合其他化療藥物）

中國

中國藥監局

2025LP00966

2025年4月IND獲批准

晚期實體瘤聯合JS207
（聯合或不聯合抗腫瘤化療）

中國

中國藥監局

2025LP03595

Ib/II期試驗階段

中國

中國藥監局

2023LP01409

I/II期試驗階段；
預計2027年下半年完成I/II期試驗
2024年2月IND獲批准

ODD

晚期實體瘤

7MW4911

6MW5311

CDH17
ADC

自主研發

LILRB4/CD3

自主研發

FDA

IND 169107

中國

中國藥監局

2025LP02657

I/II期臨床試驗階段

晚期結直腸癌及其他晚期胃腸道腫瘤

美國

FDA

IND 176738

I/II期臨床試驗階段

復發或難治性急性髓系白血病、
慢性粒單核細胞白血病及
復發或難治性多發性骨髓瘤

中國

中國藥監局

2026LP01868

2026年6月IND獲批准

美國

FDA

IND180976

2026年6月IND獲批准

中性粒細胞減少症

中國

中國藥監局

2025S01495

2025年5月獲批上市

中國

中國藥監局

2024S00481
2016L08301

2024年3月獲批上市

全球

中國藥監局、FDA

2021LP00644

II期試驗階段；
有望於2026年底啟動III期研究

全球

全球

HSA-mh G-CSF∕ 自主研發
融合蛋白
對外授權

RANKL∕地舒 自主研發； 骨巨細胞瘤、實體瘤骨轉移和多發性
單抗生物類似藥 對外授權
骨髓瘤

9MW3811

IL-11∕
單克隆抗體

自主研發

君邁康 ®

TNF-α∕
阿達木單
抗生物類似藥

1MW5011
(RP901)

BTD

中國

中國藥監局

2023LP00957

2024年5月I期試驗完成

特發性肺纖維化

澳洲

TGA

CT-2022-CTN04821-1

2023年12月I期試驗完成

美國

FDA

IND 165283

2023年6月IND獲批准

自主研發

病理性瘢痕

中國

2025LP02967

II期試驗階段

炎症性腸病、多發性硬化、1 型糖尿
病、白癜風、原發性膽汁性膽管炎等

中國

中國藥監局

2026LP01718
2026LP01776
2026LP02009
2026LP02151
2026LP02330

I期臨床試驗階段

炎症性腸病

美國

FDA

IND 180525

2026年5月IND獲批准

全球

中國

中國藥監局

2022S00142

2022年3月獲批上市

全球

中國

中國藥監局

2021LP00131

II期試驗階段；
預計於2028年完成II期試驗

大中華區

®
邁利舒

RANKL∕
單克隆抗體

自主研發； 骨折高風險的絕經後婦女的骨質疏鬆
對外授權
症

中國

中國藥監局

2024S00481

2023年3月獲批上市

全球

9MW0211

VEGF∕
單克隆抗體

自主研發

新生血管性（濕性）年齡相關性黃斑
變性

中國

中國藥監局

2020B02434

II/III期試驗完成

中國

CXSS2500098

NDA審評中

全球

2023LP00017

Ib期試驗階段；
預計2027年下半年完成Ib期試驗

2023LP00016

Ib期試驗階段

-

臨床前

4MW5411
(2MW7141)
NMPA突破療法認定

骨關節炎

糖尿病性黃斑水腫、
自主研發；
新生血管性（濕性）年齡相關性黃斑
對外授權
變性

中國

中國藥監局

真性紅細胞增多症

中國

中國藥監局

β-地中海貧血患者鐵過載
相關適應症

中國

中國藥監局

TMPRSS6∕
單克隆抗體

自主研發；
對外授權

未予披露
（雙靶點）

自主研發； 血脂異常人群的血脂調控以及高危心
對外授權
血管事件的預防
FTD

FDA快速通道認定

ODD

FTD

中國

FDA孤兒藥資格認定

ODD

多個合作方

大中華區

中國藥監局

授權引進

9MW3011

心血管疾病

中國、美
國

未予披露

VEGF-Trap∕
9MW0813
阿柏西普
生物類似藥

血液

慢性阻塞性肺疾病

除大中華區

合作研發； 克羅恩病、葡萄膜炎、多關節型幼年
對外授權
特發性關節炎等8項適應症

骨科

眼科

未披露

全球

自主研發

免疫

9MW5211

全球

美國

邁衛健 ®

ST2∕
單克隆抗體

合作夥伴

全球

晚期實體瘤

邁粒生 ®

9MW1911

商業
權利

多個合作方

多個合作方

多個合作方

大中華區、
東南亞
Kalexo (

)

臨床豁免

縮寫：ADC：抗體偶聯藥物；AS：強直性脊柱炎；B7-H3：B7同源物3；CC：宮頸癌；CD3：分化簇3；CDH17：鈣黏蛋白-17；COPD：慢
性阻塞性肺疾病；DME：糖尿病性黃斑水腫；EC：食管癌；mhG-CSF：突變型人粒細胞集落刺激因子；HSA：人血清白蛋白；IL-11：白介
素-11；nAMD：新生血管性（濕性）年齡相關性黃斑變性；Ps：銀屑病；RA：類風濕關節炎；RANKL：核因子κB受體活化因子配體；SCLC：
小細胞肺癌；ST2：致癌抑制因子2；TCE：T細胞接合器；TMPRSS6：跨膜絲氨酸蛋白酶6；TNBC：三陰性乳腺癌；TNF-α：腫瘤壞死因子
α；TOPi: 拓撲異構酶抑制劑；UC：尿路上皮癌；VEGF：血管內皮生長因子

2026年中報

邁威（上海）生物科技股份有限公司

9
管理層討論及分析

ADC產品

核心產品9MW2821：用於癌症治療的靶向Nectin-4 ADC
9MW2821（通用名Bulumtatug Fuvedotin, BFv）是利用我們的專有ADC平台及一體化高效抗體發現平台開發的
新型靶向Nectin-4 ADC。目前，公司正在針對尿路上皮癌、宮頸癌、食管癌、乳腺癌等適應症開展多項臨床
研究，現已入組超過2,200例受試者，研究結果顯示出具有突出的抗腫瘤活性和較好的安全性。我們正在中國
進行9MW2821的多項III期臨床試驗，包括作為單藥治療不可手術切除的局部晚期或轉移性尿路上皮癌、聯合
特瑞普利單抗治療不可手術切除的局部晚期或轉移性尿路上皮癌、作為單藥治療晚期或轉移性宮頸癌及作為
單藥治療對以拓撲異構酶抑制劑為載藥的ADC耐藥的三陰性乳腺癌。我們亦正在美國進行9MW2821作為單藥
治療三陰性乳腺癌的Ib期研究。
尿路上皮癌。我們正在中國進行9MW2821作為不可手術切除的局部晚期或轉移性尿路上皮癌二線或後線療法
的III期臨床試驗，計劃於2026年下半年進行中期分析，然後根據中期分析結果向NMPA提交新藥上市申請前
會議。我們還正在進行9MW2821聯合特瑞普利單抗作為不可手術切除的局部晚期或轉移性尿路上皮癌一線療
法的III期臨床試驗，並計劃於2026年下半年進行中期分析，然後根據中期分析結果向NMPA提交新藥上市申
請前會議。在進行這項試驗的同時，我們於2024年啟動一項II期析因研究，旨在比較9MW2821作為單藥療法
及聯合特瑞普利單抗療法的療效，以支持其NDA註冊。此外，我們計劃探索9MW2821聯合特瑞普利單抗用於
尿路上皮癌圍手術期治療的療效；我們於2024年11月獲得NMPA對該試驗的IND批准，並於2025年6月在中國
啟動9MW2821聯合特瑞普利單抗用於尿路上皮癌圍手術期治療的II期臨床試驗，目前處於II期臨床入組階段。
宮頸癌。9MW2821 是全球同靶點藥物中首個在宮頸癌適應症報道臨床數據的品種，也是全球首個針對宮頸
癌進入III期關鍵臨床試驗階段的靶向Nectin-4 ADC。我們正在進行9MW2821單藥作為既往接受含鉑雙藥化
療治療失敗的復發或轉移性宮頸癌的二線或三線療法的III期臨床試驗。我們預計將於2026年下半年進行中期
分析，然後根據中期分析結果向NMPA提交新藥上市申請前會議。此外，我們於2025年4月在中國啟動研究
9MW2821聯合其他抗腫瘤療法治療晚期婦科惡性腫瘤（包括宮頸癌）患者的Ib/II期臨床試驗。該臨床試驗目前
處於入組階段，隨後計劃啟動聯合療法的III期臨床試驗。

邁威（上海）生物科技股份有限公司

2026年中報

10
管理層討論及分析

三陰性乳腺癌。我們目前正在中國進行一項II期臨床試驗，以評估9MW2821單藥治療對以拓撲異構酶抑制劑
為載藥的ADC耐藥的TNBC患者或聯合特瑞普利單抗治療局部晚期或轉移性TNBC患者的療效和安全性。我們
已在中國開展9MW2821單藥作為對以拓撲異構酶抑制劑為載藥的ADC耐藥的晚期TNBC患者二線或後線療法
的III期臨床試驗，現處於入組階段。在美國，2022年7月，FDA根據我們對Nectin-4陽性轉移性實體瘤的IND
申請簽發臨床默示許可通知書，且我們於2024年12月向FDA提交9MW2821單藥治療對以拓撲異構酶抑制劑
為載藥的ADC耐藥的TNBC患者的修訂方案。FDA於2025年3月12日批准9MW2821的修訂方案。我們於2025
年8月在美國啟動9MW2821單藥治療對以拓撲異構酶抑制劑為載藥的ADC耐藥的TNBC患者的Ib期研究，現處
於入組階段。
食管癌。我們將繼續探索9MW2821聯合其他抗腫瘤療法作為EC一線療法，已於2025年6月在中國啟動Ib/II期
臨床試驗。該試驗目前處於入組階段，隨後計劃啟動聯合療法的III期臨床試驗。
9MW2821已獲得多項監管認定。FDA分別於2024年2月、2024年5月和2024年7月授予9MW2821三項快速通
道認定（「FTD」），用於治療(i)晚期、復發或轉移性食管鱗狀細胞癌（食管癌的一種），(ii)既往接受含鉑抗癌藥
物治療期間或治療後疾病發生進展的復發或轉移性CC，及(iii)局部晚期或轉移性Nectin-4陽性TNBC。此外，
FDA於2024年4月30日批准了用於治療食管癌的孤兒藥資格認定（「ODD」），而NMPA於2024年8月9日批准了
BTD，用於治療既往鉑類化療和PD-(L)1抑制劑治療失敗的局部晚期或轉移性UC。此外，於2025年1月8日，
NMPA批准9MW2821聯合特瑞普利單抗（一種抗PD-1單克隆抗體）用於治療初治、不可手術切除的局部晚期
或轉移性UC的BTD。
2026年上半年，9MW2821在多個國際會議和學術文章上對研究結果進行了介紹：
1）

2026年4月，宜賓市第二人民醫院腫瘤中心汪善兵主任團隊就宮頸癌的臨床病例，在《新英格蘭醫學雜
誌》
（NEJM，影響因子：78.5）發表文章《Hepatic Pseudoprogression after Treatment with Nectin-4Targeted Antibody-Drug Conjugate》；

2）

在2026年美國臨床腫瘤學會（「ASCO」）年會中以口頭報告形式報告了更新的9MW2821聯合特瑞普利
單抗用於治療局部晚期或轉移性UC (la/mUC)患者的Ib/II期臨床研究結果（摘要編號：4518；摘要標
題：Bulumtatug fuvedotin (BFv; 9MW2821) plus toripalimab in patients with locally advanced or
metastatic urothelial carcinoma (la/mUC): Follow-up results from a phase 1b/2study）；以壁報形式
展示了9MW2821聯合特瑞普利單抗用於圍手術期肌層浸潤性膀胱癌（「MIBC」）的II期臨床研究結果（摘
要編號：4609；摘要標題：Bulumtatug fuvedotin (BFv; 9MW2821) plus toripalimab in perioperative
patients with muscle-invasive bladder cancer (MIBC): Results of cohort A from a phase 2 study.）；

2026年中報

邁威（上海）生物科技股份有限公司

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管理層討論及分析

3）

在2026年歐洲腫瘤內科學會（「ESMO」）婦科腫瘤學年會（ESMO Gynae 2026）中以口頭報告形式報
告了9MW2821 用於復發性或轉移性CC的臨床研究結果（摘要編號：28RO；摘要標題：Bulumtatug
fuvedotin (BFv, 9MW2821)（一種Nectin-4抗體藥物偶聯物）用於復發性或轉移性宮頸癌患者：一項I/II
期研究的更新結果）。以壁報形式展示了9MW2821聯合特瑞普利單抗用於復發性或轉移性宮頸癌的Ib/
II期臨床研究結果（摘要編號：36P；摘要標題：Bulumtatug fuvedotin (BFv, 9MW2821)聯合特瑞普利
單抗用於復發性或轉移性宮頸癌患者的初步結果：一項Ib/II期臨床研究的隊列）；

4）

將在2026年ESMO年會中以口頭報告形式報告9MW2821用於以拓撲異構酶抑制劑為載荷的ADC經治的
局部晚期或轉移性TNBC的II期臨床研究結果（摘要編號：4640RO；摘要標題：Bulumtatug Fuvedotin
(BFv, 9MW2821)（一種靶向Nectin-4的ADC）用於以拓撲異構酶抑制劑(TopI)為載荷的ADC經治的局部
晚期或轉移性三陰性乳腺癌(la/mTNBC)患者：一項II期臨床試驗的研究結果）。

我們最終可能無法成功開發及銷售9MW2821。

其他ADC產品
7MW3711：用於癌症治療的靶向B7-H3 ADC
7MW3711是一款特異性靶向B7-H3（ 一種免疫檢查點蛋白）的ADC，用於治療晚期實體瘤。在食蟹猴的臨床前
安全性研究中，7MW3711顯示出良好的耐受性及藥代動力學特性。非人靈長類動物毒理學的初步研究顯示，
7MW3711的靶向毒性和脫靶毒性得到了有效控制，沒有觀察到明顯的胃腸道或血液毒性，表明其具有良好的
安全性和耐受性。我們分別於2023年8月和2023年9月在中國啟動兩項I/II期臨床試驗，以評估7MW3711單藥
治療晚期實體瘤的安全性和有效性，計劃於2027年完成這兩項研究。此外，於2024年7月，FDA批准了用於
治療小細胞肺癌的ODD。於2025年4月，NMPA批准我們提交的7MW3711聯合特瑞普利單抗（聯合或不聯合
其他化療藥物）治療晚期實體瘤受試者的Ib/II期聯合療法臨床試驗的IND申請。於2026年2月，7MW3711聯合
JS207或JS207及抗腫瘤療法治療晚期實體瘤患者的Ib/II期臨床試驗完成首例受試者入組。
肺鱗癌關鍵III期臨床試驗的溝通交流，計劃2026年下半年啟動。截至目前，全球尚無B7-H3 ADC進入肺鱗癌
III期臨床階段。與此同時，公司也積極參與2025年ASCO及ESMO大會，分別以海報形式報告了在晚期實體瘤
患者中的I/II期部分臨床研究數據。
我們最終可能無法成功開發及銷售7MW3711。

邁威（上海）生物科技股份有限公司

2026年中報

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管理層討論及分析

7MW4911：用於癌症治療的靶向CDH17 ADC
7MW4911 是一款特異性靶向CDH17 的ADC，CDH17 是一種細胞黏附蛋白及癌症治療中前景廣闊的靶點。
7MW4911集創新裸抗（Mab0727）、新型連接子及專有的MF-6載荷（一種為克服癌細胞中常見的耐藥機制而設
計的強效DNA拓撲異構酶I抑制劑）於一體。Mab0727抗體顯示出對CDH17的高特異性、快速內化能力以及以
中等親和力與人類和猴子CDH17抗原的交叉反應性。MF-6載荷通過提供強大的血漿穩定性、可控的藥物釋放
及對周圍腫瘤細胞的強效旁觀者效應，進一步增強7MW4911的療效。
2025年7月發表於《Cell Reports Medicine》的臨床前研究（標題：Overcoming multidrug resistance in
gastrointestinal cancers with a CDH17-targeted ADC conjugated to a DNA topoisomerase inhibitor）系統證
實：7MW4911通過CDH17介導的高效內化實現腫瘤選擇性細胞毒性載荷釋放，其核心優勢體現於五大維度。
分子設計方面，均質化載藥（DAR=4比例＞95%）與穩定連接子賦予優異血漿穩定性，高膜滲透性MF-6毒素產
生強效旁觀者殺傷；抗腫瘤活性方面，在結直腸癌、胃癌及胰腺癌PDX/CDX模型中均展現深度抑瘤效應，且
對RAS/BRAF等多種突變及不同CMS分型結直腸癌有效；耐藥突破方面，在ABC轉運蛋白介導的多藥耐藥模
型中療效顯著優於MMAE/DXd類ADC，並能逆轉此類ADC治療後的腫瘤進展；靶標普適性方面，對CDH17中
低表達腫瘤仍保持顯著活性；安全性方面，小鼠研究顯示有限組織分佈及食蟹猴毒理研究顯示可控代謝特徵
（適中半衰期、無蓄積傾向）和寬治療窗口，未觀察到顯著毒性信號。基於上述特性，7MW4911展現出成為晚
期消化道實體瘤變革性療法的潛力。
公司對 7MW4911 的分子結構擁有自主知識產權，並已申請相關專利。公司於 2025 年 7 月同時向 NMPA 和
FDA 提交 IND 申請，用於治療晚期實體瘤，特別是結直腸癌、胃癌、胰腺癌等消化道腫瘤。2025 年 8 月，
7MW4911的IND申請獲得FDA的許可，可開展用於晚期結直腸癌及其他晚期胃腸道腫瘤安全性、藥代動力學
和療效的I/II期研究。2025年10月，7MW4911的IND申請獲得NMPA的許可，可開展用於晚期實體瘤患者中的
安全性、耐受性、藥代動力學特徵和初步療效的I/II期臨床研究。2025年11月，7MW4911的中國I/II期臨床試
驗完成首例患者給藥。2026年1月，7MW4911用於晚期結直腸癌及其他晚期胃腸道腫瘤患者的臨床試驗在美
國完成首例患者給藥。
我們最終可能無法成功開發及銷售7MW4911。

2026年中報

邁威（上海）生物科技股份有限公司

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管理層討論及分析

非ADC產品
腫瘤
邁粒生 ®：用於癌症治療的人血清白蛋白 － 人G-CSF融合蛋白
邁粒生 ® 是一種我們自主研發的重組人血清白蛋白 － 人G-CSF融合蛋白。G-CSF是通過與其受體結合，調節中
性粒細胞早期發育、存活、遷移和活化的關鍵因子，可以促進骨髓中中性粒細胞的生成並釋放到外周血。重
組人G-CSF在人體內的半衰期相對較短。為解決這一問題，邁粒生 ® 採用了人血清白蛋白融合技術來延長半衰
期。這使得邁粒生 ® 中的G-CSF成分能夠緩慢釋放，在較長的時間內持續促進中性粒細胞的發育和釋放。
2025年5月，NMPA授予邁粒生 ® 上市許可，該藥物是我們首個創新藥上市品種，亦是首個全球上市的採用白
蛋白長效融合技術開發的G-CSF藥物。臨床試驗證明邁粒生 ® 具有良好的安全性、耐受性和有效性。邁粒生
®
獲批用於為成年非髓性惡性腫瘤患者在接受容易引起發熱性中性粒細胞減少症的骨髓抑制性抗癌藥物治療
時，使用本品降低以發熱性中性粒細胞減少症為表現的感染發生率。本品不適用於造血幹細胞移植的外周血
祖細胞的動員。
2025年6月，我們及我們的全資子公司泰康生物醫藥與齊魯製藥有限公司（「齊魯」）訂立協議，授予齊魯在大
中華區（包括中國內地、香港、澳門及台灣）獨家開發、生產、改進、利用和商業化邁粒生 ® 的權利。2025年
12月，邁粒生 ® 開始銷售，且成功新增納入《國家基本醫療保險、工傷保險和生育保險藥品目錄（2025年）》。
該目錄於2026年1月1日起在全國範圍內正式執行。邁粒生 ® 作為全球首款人血清白蛋白（「HSA」）融合技術的
新一代長效G-CSF，其醫保准入帶來療效安全雙提升，可優化目錄結構，進一步提高治療依從性。

邁威（上海）生物科技股份有限公司

2026年中報

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管理層討論及分析

邁衛健 ®：地舒單抗的生物類似藥
邁衛健 ® 是中國第一梯隊獲批上市用於治療骨巨細胞瘤的地舒單抗(120mg)生物類似藥。地舒單抗是一款靶向
藥物，可結合並抑制RANKL（一種調節骨細胞活性的蛋白質）。通過中和RANKL，地舒單抗可減少骨吸收，增
加骨量和骨強度。地舒單抗最初於2010年在美國以XGEVA ®（安加維 ®）品牌獲批，用於實體瘤骨轉移患者骨骼
相關事件的預防。
2024年3月，NMPA批准邁衛健 ® 的NDA，用於治療不可手術切除或手術切除可能導致嚴重功能障礙的骨巨細
胞瘤。2026年5月，邁衛健 ® 用於SREs適應症（用於實體腫瘤骨轉移患者和多發性骨髓瘤患者的治療，以延遲
或降低骨相關事件（病理性骨折、脊髓壓迫、骨放療、骨手術）的發生風險）的補充申請獲得批准。
在海外商業化方面，2025年8月，邁衛健 ® 在巴基斯坦獲批上市，這是巴基斯坦獲批的首個XGEVA ® 生物類似
藥。2026年2月，泰康生物順利通過約旦食品藥品監督管理局針對地舒單抗的GMP現場檢查。此外，截至最
後實際可行日期，本公司已就9MW0321與巴西、哥倫比亞、印度尼西亞、新加坡、巴基斯坦、泰國、埃及、
秘魯、沙特阿拉伯等33個國家簽署正式合作協議，並已向約旦、埃及、巴西等8個國家提交註冊申請資料，
其他國家註冊申請亦在準備中。

2026年中報

邁威（上海）生物科技股份有限公司

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管理層討論及分析

6MW5311：靶向CD3和白細胞免疫球蛋白樣受體B亞家族成員4（「LILRB4」）的T細胞接合器（「TCE」）
6MW5311是一款靶向CD3和LILRB4的TCE，旨在治療復發或難治性急性髓系白血病（「AML」）、慢性粒單核細
胞白血病（「CMML」）以及復發或難治性多發性骨髓瘤（「MM」）。
LILRB4是一種I型膜蛋白，其胞質區含有免疫受體酪氨酸抑制基序（「ITIM」），主要在髓系細胞中表達，負向調
控免疫細胞活化。該受體在單核系AML中表達上調，同時也見於CMML和MM。6MW5311通過同時結合CD3
與LILRB4，將T細胞與腫瘤細胞橋接，促進免疫突觸形成，進而激活T細胞並殺傷腫瘤。該分子經獨特結構設
計，在無腫瘤環境下對T細胞的結合活性極低，而在腫瘤與T細胞共存的微環境中則表現出強效殺傷作用，在
保障療效的同時顯著提高了安全性。臨床前研究顯示，6MW5311在高、低LILRB4表達的AML模型中均能有
效抑制腫瘤生長，並在高表達模型中近乎完全清除腫瘤；食蟹猴安全性評價也表明其具有良好的安全特性。
2026年6月，6MW5311針對血液瘤（AML、CMML以及MM）的IND申請先後獲得FDA許可和NMPA批准。
我們最終可能無法成功開發及上市6MW5311。

邁威（上海）生物科技股份有限公司

2026年中報

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管理層討論及分析

免疫
關鍵產品9MW1911：用於治療自身免疫性疾病的靶向ST2單克隆抗體
9MW1911是國內首款靶向ST2單克隆抗體。白細胞介素-33（「IL-33」）╱ST2信號通路在各種炎症反應中起著
重要作用，包括慢性阻塞性肺疾病（「COPD」）。白介素33(IL-33)，是IL-1細胞因子家族的成員，是一種在組織
損傷和炎症過程中釋放的細胞因子，主要在組織和免疫細胞中表達，通過與ST2及IL-1RAcP組成的異二聚體
受體結合在靶細胞上發揮作用，隨後激活細胞內的信號通路。ST2又稱IL-33受體，在激活後可激活下游蛋白
質，並介導對細胞因子IL-33的反應。IL-33/ST2通路與多種炎症疾病的發生和進展密切相關，在臨床上已被證
明是一個有效治療炎症 ╱ 過敏反應的靶點，且IL-33/ST2通路是賽諾菲已上市藥品度普利尤單抗（靶向IL-4Rα）
所針對的IL-4/IL-13信號傳導通路的上游通路，相比之下具有更廣泛的藥理作用。
度普利尤單抗是一種靶向IL-4Ra的抗體，在美國、歐洲和中國獲批由賽諾菲銷售。因此，與度普利尤單抗相
比，9MW1911具有更廣泛的藥理學特徵。此外，度普利尤單抗在COPD中顯示出積極的進展，適用於COPD
的2型炎症患者（血液嗜酸性粒細胞≥300個細胞 ╱μL的患者），並不會限制人群中之戒煙行為。然而，從流行
病學角度來看，COPD的主要特徵是嗜酸性粒細胞計數低於300個細胞 ╱μL的患者。在一項分析COPD患者嗜
酸性粒細胞水平的研究中，COPD患者總數中僅約31%的患者的嗜酸性粒細胞計數≥300個細胞 ╱μL。同樣，
TSLP抗體的初步結果表明TSLP抗體在嗜酸性粒細胞水平高的患者人群中也有效。與度普利尤單抗及靶向TSLP
抗體相比，靶向ST2/IL-33通路的藥物不會限制嗜酸性粒細胞計數，這表明9MW1911的人群更廣泛。

2026年中報

邁威（上海）生物科技股份有限公司

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管理層討論及分析

我們分別於2022 年10 月及2023 年6 月在中國完成針對健康受試者的兩項I期臨床試驗。我們於2023 年7 月在
中國啟動針對COPD患者的Ib/IIa期試驗，並已於2026年3月完成IIa期試驗。我們於2025年7月在中國啟動針
對COPD患者的另一項II期試驗，預期於取得至少120 名受試者的52 周隨訪數據後進行中期分析。該研究於
2026年6月已完成末例受試者給藥，目前處於受試者隨訪階段。我們計劃於2026年底前後推進在中國進行的
9MW1911治療COPD患者的III期臨床試驗。2025年12月，FDA授予在美國開展9MW1911治療COPD的IIa期臨
床試驗的IND批准。
我們最終可能無法成功開發及銷售9MW1911。
9MW3811：用於纖維化相關疾病及癌症治療的靶向IL-11的人源化單克隆抗體
IL-11 是一種細胞因子，在慢性炎症和纖維化相關疾病中起關鍵作用，還與衰老相關疾病的發生密切相關。
9MW3811是我們自主研發的一款創新單克隆抗體。憑藉對IL-11的高親和力和強中和活性，9MW3811可有效
阻斷由IL-11介導的下游信號通路，從而干預某些慢性炎症和纖維化相關疾病的病理進程。我們在9MW3811
的可結晶片段（「Fc」）區域引入了LALA修飾（L234A/L235A），以消除其與免疫細胞上多種Fc受體的結合，
從而降低 F c 介導的毒性風險。臨床試驗結果表明，該修飾還可通過減少 9M W3811 的肝臟代謝，從而使
9MW3811保持較長的半衰期。
9MW3811在多種肺纖維化動物模型中表現出顯著的治療效果。在小鼠模型中，9MW3811顯著降低了肺纖維
化面積，減少了肺膠原含量，並改善了肺功能，表明其有望成為治療肺纖維化相關疾病的有效藥物。此外，
9MW3811在一些纖維化相關的其他適應症中也展現出顯著療效，例如瘢痕生長抑制、子宮內膜異常出血等。
我們於2025年5月在《npj Precision Oncology》上發表9MW3811的臨床前研究。詳細闡述了9MW3811的分子
特性優勢：1）具有更強的IL-11/IL-11R信號阻斷效率及更高的親和力；2）分子設計使其在人體內擁有超過1個
月的半衰期，更適合需長期給藥的慢性疾病治療。
9MW3811已獲得全球多個監管機構的IND批准。我們分別於2023年12月及2024年5月在澳大利亞及中國完成
9MW3811針對健康受試者的I期臨床試驗。此外，我們於2023年6月就針對特發性肺纖維化的臨床試驗獲得
FDA的IND批准。於2025年11月獲NMPA批准9MW3811針對病理性瘢痕（包括增生性瘢痕和瘢痕疙瘩）臨床試
驗的IND申請，使9MW3811成為首款進入病理性瘢痕（包括增生性瘢痕和瘢痕疙瘩）治療臨床階段的IL-11靶向
藥物。我們於2025年12月啟動9MW3811針對病理性瘢痕（包括增生性瘢痕和瘢痕疙瘩）的臨床試驗。現已完
成首例患者給藥，成為全球首個探索病理性瘢痕適應症的IL-11靶向抗體藥物。
2025年6月，我們與Calico Life Sciences LLC（「Calico」）訂立獨家許可協議，授予Calico在除大中華區以外
的所有區域獨家開發、生產和商業化IL-11靶向療法（包括9MW3811）的權利。
我們最終可能無法成功開發及上市9MW3811。

邁威（上海）生物科技股份有限公司

2026年中報

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管理層討論及分析

9MW5211：用於治療自身免疫性疾病的單克隆抗體
9MW5211是公司自主研發的一種高度特異性的清除型創新抗體，針對自身免疫性疾病中由異常免疫細胞介導
的關鍵病理機制進行精準干預。免疫細胞的異常活化及組織浸潤是多種自身免疫疾病發生發展的核心驅動因
素。9MW5211所靶向的分子在致病性免疫細胞表面特異性表達，是這些細胞異常活化的重要生物學標誌。通
過選擇性識別並清除這群致病性細胞，9MW5211可有效阻斷免疫級聯反應，進而緩解疾病進展並改善臨床症
狀。
經過多輪分子工程優化，9MW5211展現出優異的靶點選擇性，在實現高效阻斷的同時，顯著降低了非特異性
結合風險，確保其對高表達靶點蛋白的致病性細胞實現深度清除。該獨特的作用機制，不僅有望帶來更深層
次的疾病緩解，也可能支持更長的給藥間隔，從而提升患者治療的依從性與生活質量。
臨床前研究結果顯示，9MW5211在多種小鼠自身免疫疾病模型中均表現出顯著的治療潛力，適應症涵蓋炎症
性腸病（「IBD」）、多發性硬化症（「MS」）、原發性膽汁性膽管炎（「PBC」）、1型糖尿病（「T1DM」）和白癜風
等。同時，在食蟹猴模型中開展的安全性評估顯示其具備良好的安全性特徵。
2026 年5 月，9MW5211 針對IBD的IND申請獲FDA許可。2026 年6 月，該藥物針對IBD和MS的IND申請先後
獲得 NMPA 批准；同月，9MW5211 在中國開展的 I 期臨床試驗完成首例受試者給藥。2026 年 7 月，其針對
T1DM、PBC和白癜風的IND申請先後獲得NMPA批准。公司亦在積極推進其他適應症IND申請工作。
作為全球首個針對該靶點的臨床階段的候選藥物，9MW5211有望開啓自身免疫疾病精準治療的新篇章。
我們最終可能無法成功開發及上市9MW5211。
君邁康 ®：阿達木單抗的生物類似藥
君邁康 ® 是一款阿達木單抗生物類似藥，靶向並中和炎症細胞因子TNF-α，通過阻斷TNF-α，可以減少炎症並
調節免疫系統活性。阿達木單抗於2002年首次在美國被批准用於醫療用途，其品牌名為修美樂，被廣泛用於
治療各種自身免疫性及炎症性疾病，包括類風濕關節炎、銀屑病關節炎、強直性脊柱炎、克羅恩病、潰瘍性
結腸炎、斑塊狀銀屑病、化膿性汗腺炎及葡萄膜炎。

2026年中報

邁威（上海）生物科技股份有限公司

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管理層討論及分析

2022年3月，NMPA批准君邁康 ® 的NDA，授權其用於治療類風濕關節炎、強直性脊柱炎及銀屑病，君邁康 ®
得以商業化。隨後，2022年11月，NMPA批准君邁康 ® 的補充申請，以增加克羅恩病、葡萄膜炎、多關節型
幼年特發性關節炎、兒童斑塊狀銀屑病、兒童克羅恩病等適應症。截至最後實際可行日期，君邁康 ® 被納入
中國國家醫保藥品目錄；我們在菲律賓、摩洛哥、阿根廷等17個國家簽訂商業化協議，並已向巴基斯坦、約
旦、祕魯等6個國家遞交了註冊申請文件；2025年12月，君邁康 ® 在印度尼西亞獲批上市，印尼為PIC/S成員
國。

骨科
1MW5011(RP901)：用於骨關節炎治療的小分子藥物
骨關節炎是一種慢性退行性疾病，病徵為關節疼痛，由多種因素引起，可導致關節軟骨纖維化、裂縫、潰瘍
及喪失，嚴重影響患者的生活質量，已成為第四大致殘疾病。骨關節炎的發病率與性別及年齡密切相關。
骨關節炎治療的主要目的是緩解疼痛、維持或改善關節功能以及保護關節結構。目前的治療方案包括口服和
外用非甾體抗炎藥等鎮痛類藥物，以及關節腔內注射糖皮質激素和玻璃酸鈉。常用口服藥物包含非甾體抗炎
藥、阿片類藥物、關節軟骨保護藥（如氨基葡萄糖、軟骨素、雙醋瑞因）。但長期使用非甾體抗炎藥可能引發
胃腸道出血穿孔等不良反應，還會增加心血管疾病風險；而阿片類藥物由於具有成癮性及呼吸抑制等潛在安
全隱患，僅適用於慢性骨關節劇痛的短期治療。此外，現有治療手段均無法改變骨關節炎的自然病程。許多
患者因種種原因未能獲得及時有效治療，導致病情遷延最終致殘。

邁威（上海）生物科技股份有限公司

2026年中報

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管理層討論及分析

1MW5011(RP901)是一種全新化學物實體，口服後可在體內快速轉化為N－ 丁醯基氨基葡萄糖，發揮骨保護
和對骨關節炎的改善 ╱ 治療作用。臨床前藥效學研究顯示，N－ 丁醯基氨基葡萄糖能顯著促進牛軟骨細胞增
殖和蛋白多糖的合成，增加大鼠軟骨細胞II型膠原的表達。用源於骨關節炎患者及健康受試者的關節軟骨進
行的臨床前研究表明，N－ 丁醯基氨基葡萄糖可明顯促進軟骨細胞合成代謝，抑制軟骨細胞分解代謝。對大
鼠和猴子進行的放射性同位素標記研究顯示，口服[14C]N－ 丁醯基氨基葡萄糖後，在骨胳、骨髓及膝關節相
關區域均檢測到強放射性信號，表明其優異的口服生物利用度和良好的骨關節分佈特性。1MW5011(RP901)
治療膝骨關節炎的II期臨床試驗，首名患者於2024年7月給藥，預計該試驗將於2028年完成。此外，我們於
2025年12月啟動評估1MW5011(RP901)治療膝骨關節炎患者安全性、耐受性及初步有效性的Ib期臨床試驗，
於2026年4月完成了末例受試者入組，處於受試者隨訪階段。
我們最終可能無法成功開發及銷售1MW5011(RP901)。
邁利舒 ®：地舒單抗的生物類似藥
邁利舒 ® 是中國第二款獲批上市用於治療骨質疏鬆症的地舒單抗生物類似藥。地舒單抗是一種靶向治療，作為
RANKL抑制劑，阻止破骨細胞介導的骨吸收。通過抑制RANKL，地舒單抗可以減少骨折高風險患者的骨質流
失，增加骨量及強度。
2023 年3 月，NMPA批准邁利舒 ® 的NDA，用於治療骨折高風險的絕經後婦女的骨質疏鬆症。我們將繼續研
究邁利舒 ® 在其他類型骨質疏鬆症的作用。2025年8月，邁利舒 ® 在巴基斯坦獲批上市。截至最後實際可行日
期，邁利舒 ® 已被納入中國國家醫保藥品目錄。我們認為，邁利舒 ® 可以為需要靶向RANKL治療的骨質疏鬆症
患者提供一種新的、具有成本效益的生物類似藥治療選擇。通過提供高質量的地舒單抗獲批生物製劑，邁利
舒 ® 旨在提高患者對該重要療法的可及性及可負擔性，幫助骨折風險升高的患者保持骨量及強度。

2026年中報

邁威（上海）生物科技股份有限公司

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管理層討論及分析

在海外商業化方面，2026 年2 月，泰康生物順利通過約旦食品藥品監督管理局針對地舒單抗的 GMP現場檢
查，這是邁威生物首次通過PIC/S成員國藥監機構的GMP現場檢查。此前，該產品獲得巴基斯坦藥品監督管理
局註冊批准，不僅是巴基斯坦獲批的首個Prolia ® 生物類似藥，也是公司首個獲得海外註冊批件的產品，加速
了公司的全球化佈局。截至最後實際可行日期，針對9MW0311，公司已與巴西、哥倫比亞、印尼、新加坡、
巴基斯坦、泰國、埃及、祕魯、沙特阿拉伯等33個國家簽署正式合作協議，並已向約旦、埃及、巴西等8個
國家遞交了註冊申請文件，其他國家註冊申請亦在準備中。公司將持續利用現有的新興市場的商務網絡和拓
展能力，快速推進該品種海外市場的合作及註冊上市。此外，公司積極探索創新業務模式。2024年，公司與
重慶高新技術產業開發區管理委員會及重慶中新醫藥大健康私募股權投資基金合夥企業（「大健康基金」）訂立
三方《邁威生物骨健康創新藥項目合同》。以邁威重慶作為實施該項目的項目主體，三方共同投資建設「邁威
生物骨健康創新藥項目」。截至最後實際可行日期，邁威重慶已收到大健康基金支付的首期出資人民幣200百
萬元。

眼科
9MW0211：用於眼科疾病治療的靶向VEGF-A單克隆抗體
9MW0211是一款重組人源化單抗，靶向VEGF-A（VEGF蛋白家族中生物活性最強的成員）。9MW0211利用兔
單抗及人源化改構技術開發，設計用於治療靶向VEGF治療相關疾病等潛在適應症，如新生血管性（濕性）年
齡相關性黃斑變性（「nAMD」）、糖尿病性黃斑水腫（「DME」）及視網膜靜脈閉塞（「RVO」）。通過特異性結合
及中和VEGF-A，9MW0211阻斷其與內皮細胞表面受體的相互作用，進一步減輕血管通透性，阻斷新生血管
的生成及發展。因此，9MW0211可抑制導致眼部疾病的病理性新生血管生成及血管滲漏。公司於2025年12
月完成II/III期臨床試驗，正在籌備該品種的後續臨床研究。

邁威（上海）生物科技股份有限公司

2026年中報

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管理層討論及分析

公司分別於2026年5月在Retina China 2026大會，2026年6月在第四十屆世界眼科大會（「WOC」）上以口頭
彙報形式公佈了評價重組抗VEGF人源化單克隆抗體注射液9MW0211在nAMD中有效性和安全性的II/III期臨
床研究結果。結果顯示，9MW0211 1.5mgQ4W組第52周時最佳矯正視力（「BCVA」）平均較基線改善14.1個
字母，非劣於雷珠單抗Q4W組。解剖學療效指標方面，9MW0211 1.5mg Q4W組在第52周時中央視網膜厚
度（「CRT」）平均減少205.6微米，較雷珠單抗組（減少141.0微米）展現出更強的積液改善優勢，且9MW0211
Q4W 組視網膜內和視網膜下無積液的患者比例在第12、24 和 52 周時持續高於雷珠單抗組。安全性方面，
9MW0211整體劑量組與雷珠單抗組的治療期間不良事件（「TEAEs」）發生率相當。
我們最終可能無法成功開發及銷售9MW0211。
9MW0813：阿柏西普的生物類似藥
9MW0813是一款重組人VEGF受體 － 抗體融合蛋白阿柏西普的生物類似藥。阿柏西普阻斷VEGF，結合並中和
VEGF。通過阻止VEGF與其內皮細胞上的受體相互作用，阿柏西普抑制驅動血管異常生長及增加血管通透性
的信號通路。阿柏西普於2011年首次在美國獲得批准，並以Eylea品牌上市，用於治療濕性AMD。隨後，阿
柏西普獲批聯合化療用於治療若干類型的轉移性結直腸癌。
公司已向NMPA提交NDA，並於2025 年9 月獲受理，目前處於註冊審評階段。9MW0813 有望作為一種高質
量、低成本的生物類似藥治療以血管異常生長及血管通透性增加為特徵的眼科疾病。
2026年5月，公司在第二十七屆眼底病論壇暨國際視網膜研討會（Retina China 2026）以口頭報告形式公佈了
9MW0813針對DME的III期臨床研究結果。在海外商業化方面，公司於2026年7月在菲律賓、越南、馬來西亞
分別與當地合作方達成許可協議，將與合作方共同推進9MW0813在當地的註冊和商業化。同月，公司與沙特
阿拉伯生物製藥公司SVAX Inc.達成許可協議，雙方就9MW0813在海灣阿拉伯國家的註冊、生產和商業化展
開深度合作；此前，公司已與一家印度製藥公司達成供貨和商業化協議，該合作公司獲得9MW0813在印度進
口、生產、註冊、上市和銷售的獨家權利，並有權獲得包括南亞及非洲部分國家在內的10個國家的非獨家權
利。這些合作標誌著公司在中東、南亞和非洲地區向前邁出了堅實的一步，也提高了公司產品在當地患者群
體中的可及性。

2026年中報

邁威（上海）生物科技股份有限公司

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管理層討論及分析

我們最終可能無法成功獲得上市批准及銷售9MW0813。
血液
9MW3011：用於血液系統疾病治療的抗TMPRSS6抗體
9MW3011是全球開發進度領先的靶向TMPRSS6療法之一。9MW3011為一款由全資子公司邁威（美國）自主研
發的重組人源化抗TMPRSS6單克隆抗體。其靶點主要表達在肝細胞膜表面，9MW3011單抗可通過特異性地與
TMPRSS6結合，上調肝細胞表達鐵調素（Hepcidin）的水平，抑制鐵的吸收和釋放，降低血清鐵水平，從而調
節體內的鐵穩態。
鐵調素（Hepcidin）是調節機體鐵穩態的核心激素，通過與其受體ferroportin結合，促進其細胞內吞和降
解，減少腸道對鐵的吸收及巨噬細胞和肝細胞中儲存鐵的釋放，達到控制血液中鐵水平的效果。作用靶點
TMPRSS6是一種II型跨膜絲氨酸蛋白酶，由TMPRSS6基因編碼，主要在肝臟表達，是Hepcidin表達的關鍵負
向調控因子。9MW3011作為一款抗TMPRSS6單克隆抗體，可特異性結合TMPRSS6，阻斷TMPRSS6對於BMP/
SMAD通路的抑制作用，從而上調Hepcidin的表達，抑制鐵吸收、釋放，降低血清鐵水平。非臨床研究結果
表明，9MW3011安全性和耐受性良好。在真性紅細胞增多症小鼠模型中，使用抗TMPRSS6抗體進行治療，可
顯著降低真性紅細胞增多症小鼠的紅細胞數、血紅蛋白水平和紅細胞壓積，起到明顯的治療效果。
基於TMPRSS6在Hepcidin-ferroportin軸的重要作用及靶點相對專一性，靶向TMPRSS6可能在以地中海貧血為
代表的鐵過載性貧血和限制鐵利用可獲益的紅細胞疾病如真性紅細胞增多症等多種鐵代謝紊亂疾病中具有潛
在的治療作用。目前，相關適應症領域在全球不同地區被列為罕見病，已上市或處於臨床開發階段的藥物多
為小分子、多肽、寡核苷酸或基因治療藥物，從安全性、耐受性和患者依從性等方面均存在巨大的未滿足的
臨床需求。9MW3011與之相比，具有半衰期長、安全性好、治療成本低的優勢，立足調節鐵穩態，有望為鐵
過載性貧血及真性紅細胞增多症等治療領域提供一種新的治療方式。
與9MW3011作用機理相近的項目是2024年2月武田支付3億美元預付款許可引進的Protagonist公司Rusfertide
項目。Rusfertide是一種外源性鐵調素模擬物，直接模擬鐵調素的功能調控人體鐵穩態，III期臨床研究方案
為每週一次給藥，目前上市申請已被FDA受理。2025年3月3日，武田 ╱Protagonist聯合宣佈該藥對使用標
準治療（包括靜脈切開術）無法良好控制的真性紅細胞增多症患者的註冊性III期臨床研究達到了主要終點，表
明該上調鐵調素治療真性紅細胞增多症的策略安全有效，驗證了該通路作用機制的科學性與可行性。根據武
田 ╱Protagonist的調研，美國的真性紅細胞增多症患者有15.5萬人，診斷後平均生存期為14年。Rusfertide
初步的定位為真性紅細胞增多症的中期療法，年銷售額預計超過20億美元。

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9MW3011 通過調控該通路上游信號從而上調內源性鐵調素的表達，可能帶來較為符合生理機制的鐵調節
效果。考慮到鐵穩態異常相關的血液疾病通常需要長期給藥，內源性藥物可能具有更佳的安全性優勢，
9MW3011可支持每四週一次給藥，具有更好的便利性，能提高患者的依從性。9MW3011有望成為全球範圍
內領先的調節體內鐵穩態的大分子藥物。
2023年1月，公司全資子公司邁威（美國）就9MW3011與DISC MEDICINE, INC.（「DISC」）達成獨家許可協議。
根據協議，DISC將獲得除大中華區和東南亞以外所有區域內獨家開發、生產和商業化以及以其他方式開發
9MW3011的權利。邁威（美國）可獲得合計最高達4.125億美元的首付款及里程碑付款，另外可獲得許可產品
淨銷售額最高近兩位數百分比的特許權使用費，目前DISC已經向邁威（美國）支付一次性不可退還的首付款
1,000萬美元及3筆里程碑付款。
2023年9月，9MW3011注射液獲得FDA授予FTD，用於治療真性紅細胞增多症；2024 年2月，獲得FDA授予
ODD。
截至最後實際可行日期，全球尚未批准任何靶向TMPRSS6藥物，有7款處於臨床階段的靶向TMPRSS6在研藥
物，其中9MW3011為國內首家，且是目前全球唯一一款用於真性紅細胞增多症治療的靶向TMPRSS6單抗。
我們於2024年5月在中國完成針對健康受試者的I期試驗，正在中國開展針對真性紅細胞增多症患者的兩項Ib
期臨床試驗。
我們已完成其中一項針對真性紅細胞增多症的Ib期臨床試驗的最後一例患者入組，預計於2027年下半年完成
臨床試驗。另一項試驗已於2025年1月完成首例患者入組、2025年11月完成最後一例患者入組，並於2026年
6月完成最後一例患者訪視。
2026年6月，9MW3011在2026年歐洲血液學協會（EHA）年會上以壁報形式公佈了針對真性紅細胞增多症患
者的Ib期臨床（CTR20240408）研究結果（摘要編號：PF-908；摘要標題：A PHASE IB STUDY OF 9MW3011,
A FIRST-IN-CLASS ANTI-TMPRSS6 ANTIBODY, IN RELAPSED/REFRACTORY PATIENTS WITH POLYCYTHEMIA
VERA）。該研究通過試驗參與者達到無降細胞治療狀態（即無需進行降細胞干預治療，如使用羥基脲和干擾
素-α）的時長和比例來評估其初步有效性。結果顯示，150 mg Q4W、150 mg Q2W和300 mg Q4W組試驗參
與者的中位無降細胞治療時長分別達到120天、139天和197天，隨劑量增加而延長；達到無降細胞治療時長
的參與者比例分別為43%、57%和83%，隨藥物暴露水平升高而增加。研究結果表明，9MW3011有潛力延長
真性紅細胞增多症患者的無降細胞治療時長，從而減少降細胞治療相關不良反應，改善真性紅細胞增多症患
者的生存獲益。
我們最終可能無法成功開發及銷售9MW3011。

2026年中報

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技術平台
①

一體化高效抗體發現平台
公司的一體化高效抗體發現平台利用多種先進技術為生成單克隆抗體提供全面、多功能的解決方案。
該平台配備自動化、高通量雜交瘤發現體系、單一B細胞篩選方法、酵母展示系統及全人源鼠抗體生
成系統，能夠實現在鼠源、全人源、兔源抗體以及納米抗體等多種形態中的快速、高質量抗體發現，
尤其適合用於生成針對低免疫原性抗原的抗體，如擁有短的細胞外結構域或細胞外環狀結構域的多次
跨膜蛋白。該平台優於傳統發現方法，適合用於生產更高特異性和親和性的高效力抗體。此外，該平
台能夠生成諸如中和抗體、阻斷抗體以及功能性激動劑及拮抗劑等具備多種功能特性的抗體，可滿足
不同治療領域的特定需求。通過整合該等先進技術，該平台可加速抗體篩選，縮短開發時間線及最大
化抗體的治療潛力，從而為廣泛臨床適應症提供更高效且有針對性的解決方案。

②

ADC藥物開發平台
我們已建立擁有自主知識產權（「知識產權」）的四大核心ADC技術：DARfinity TM，我們自主研發的定點
偶聯工藝；IDconnect TM，一種經過優化設計的連接子分子，用以連接抗體和毒素，使抗體和毒素之
間的連接更穩定；Mtoxin TM，一種基於喜樹鹼的新型毒性分子，用作ADC中殺死靶細胞的「彈頭」；及
LysOnly TM，一種能夠有條件釋放毒素的結構，可提高ADC的整體安全性和有效性。ADC技術優勢具體
如下：
－

DARfinity TM 是一種定點偶聯技術，能夠使藥物和抗體精準、受控偶聯，產生均一性高的同質化
DAR 4 ADC。DAR比率是ADC的一項關鍵質量屬性，DAR為4通常被視為可向每個抗體提供充
足數量的藥物分子，而不會提高細胞毒性。較高的DAR可能導致細胞毒性上升及脫靶的不良反
應，而較低的DAR可能使藥物無效。傳統ADC通常依賴隨機偶聯方法，使細胞毒性有效載荷附
於抗體的多個位置，導致形成具有不同DAR的ADC混合物（例如，即使平均DAR為4，但批次間
DAR2、DAR4、DAR6以及DAR8的具體比例也是波動的）。這導致每一批次的異質性較大，從而
影響ADC的有效性和安全性。DARfinity TM 通過仔細挑選偶聯具體位置，確保有效載荷僅附於預
先確定的位置，從而克服該挑戰。DARfinity TM 降低異質性，使最終產品中的所有ADC分子在結
構和載藥量方面幾乎保持一致。利用DARfinity TM，DAR值為4的主要品種純度達到95%以上。通
過尺寸排阻色譜和疏水作用色譜分別測量，主要品種的純度可達99%和97.3%。相較於採用傳
統非定點偶聯工藝的DAR4 ADC，DARfinityTM 通過精準定點偶聯策略使產物單體純度實現突破
性提升，HIC定量分析顯示關鍵質量屬性優化幅度超行業平均水平。通過公司的DARfinity TM 技
術實現的高純度均勻偶聯可改善ADC藥品的主要表現，包括藥代動力學、穩定性以及安全性和
有效性。

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－

IDconnect TM 是一種定點偶聯連接子技術，特點是採用具有自水解功能的芳香環結構設計，能
夠有效抑制由巰基 － 逆邁克爾加成反應導致的連接子提前脫落，從而避免由此引發的脫靶效應
和ADC水平的耗竭。在傳統ADC設計中，通常使用馬來酰亞胺連接子，通過巰基 － 邁克爾加成
反應與還原抗體中的巰基形成硫醚鍵，從而實現ADC偶聯。在某些條件（如pH值呈酸性或酶的
存在）下，硫醚鍵可斷裂並反轉（稱為巰基 － 逆邁克爾加成反應），導致藥物的早期解離及有效
載荷的過早釋放。如果馬來酰亞胺完全水解，巰基 － 逆邁克爾加成反應所需的反應位點將會去
除，從而保持連接子與抗體穩定連接。公司的IDconnect TM 結構是擁有兩個反應位點的二取代馬
來酰亞胺。該連接子能與抗體中四對鏈間二硫鍵（經TCEP還原後所形成的巰基）發生反應，生
成DAR為4的ADC藥物。此外，每個連接子可同時與一對抗體的二硫鍵（還原後的巰基）偶聯，
且公司設計雙氟苯基的水解結構以增強ADC藥物的穩定性。具體而言，雙氟苯基結構使馬來酰
亞胺可自水解。經水解的馬來酰亞胺可抑制ADC藥物在血液循環過程中與血漿白蛋白中的巰基
發生逆邁克爾加成反應，從而防止毒素進入血液。因此，通過IDconnect TM 賦能的連接子設計，
公司希望藉由加強抗體和毒素之間的連接來提高ADC的穩定性，從而降低血漿中有效載荷的過
早釋放。

－

LysOnly TM 是一種有條件釋放結構，利用特定酶降解從ADC分子中釋放毒性有效載荷。通過這
種方式，ADC分子能夠在血液循環中保持完整，只在靶細胞內釋放有效載荷，從而降低脫靶毒
性，提高整體安全性。

－

Mtoxin TM 是一類基於喜樹鹼的新型載荷。臨床前研究顯示，與ADC中常用的其他細胞毒性載荷
（如DXd和SN38）相比，Mtoxin TM 憑藉其較高的膜滲透性，表現出更強的腫瘤抑制作用和更好的
旁觀者殺傷作用。雖然Mtoxin TM 的抗腫瘤活性增加，但不會增加副作用或降低整體耐受性。因
此，公司認為MtoxinTM 能夠改善ADC產品的整體治療效果和治療窗口。

這四項專有技術是公司ADC產品開發平台IDDC TM 的支柱，具有定點偶聯特性，可以幫助公司開發更均
一、更穩定、純度更高、潛在療效更好、更安全的優化ADC。
③

TCE雙特異性及三特異性抗體開發平台
我們自主開發的TCE雙 ╱ 三特異性抗體平台，採用創新的差異化設計策略，實現了從分子設計到生產
工藝的一體化解決方案。該平台能夠針對不同腫瘤類型和治療需求進行抗體藥物的定制化開發，顯著
提升了從早期研發到CMC及生產的全流程效率。

2026年中報

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管理層討論及分析

平台的核心技術優勢在於其自主開發的CD3 抗體分子庫。這些具有自主知識產權的抗體分子具備不
同的結合活性和激活能力：一方面保持對人CD3的高親和力，另一方面具有與食蟹猴CD3的交叉反應
性。這一特性為在非人靈長類動物模型中準確評估TCE分子的安全性提供了關鍵工具。特別值得注意
的是，該抗體庫涵蓋了從強效激活到溫和激活的完整活性譜系，為針對不同腫瘤適應症的選擇性激活
提供了精準的技術支持。
在分子構建方面，平台支持多種抗體形式的設計，包括傳統的對稱結構和創新的非對稱結構等。這種
多樣化的設計策略使研發人員能夠根據靶點特性選擇最優分子形式，實現對不同表達水平腫瘤抗原的
精準靶向。其中最具創新性的是「空間位阻構象依賴性」設計：通過精密的分子設計，抗體在血液循環
系統中保持非激活狀態，顯著降低系統性免疫激活帶來的毒副作用；而在腫瘤微環境中，通過Fab端
與腫瘤相關抗原（「TAA」）的特異性結合引發構象變化，暴露出CD3結合位點，從而實現對浸潤T細胞
的高效激活。這種獨特的「雙鎖」機制在提高治療安全性的同時，確保了優異的腫瘤殺傷效果。
在靶點篩選方面，邁威生物建立了整合多組學分析、計算生物學和人工智能技術的智能化靶點發現及
評估系統。該系統採用三級篩選策略：首先通過生物信息學分析確定具有重大未滿足臨床需求的適應
症領域；其次評估現有免疫治療（「IO」）和ADC管線的競爭格局；最後針對篩選出的適應症挖掘和評估
成熟及創新靶點。這種系統化的篩選方法確保了靶點選擇的科學性和臨床轉化價值，目前已成功識別
出多個具有開發潛力的新靶點。
此外，平台的另一個技術突破還體現在三特異性抗體的開發上。通過引入第二刺激信號，顯著增強了T
細胞的激活效能和持久性。研發團隊建立了完整的信號組合篩選平台，對多種刺激信號組合進行系統
評估，並開發出特有的「信號平衡」技術。該技術確保在增強活性的同時，維持關鍵的TAA依賴性激活
模式。
目前，平台已產生多個臨床前候選化合物（「PCC」），在臨床前研究中展現出顯著的腫瘤抑制效果和良
好的安全性特徵。該平台已經推進6MW5311進入臨床階段。公司將持續深化平台技術創新，重點開發
新一代TCE技術，並積極探索與IO及ADC等的聯合治療策略。隨著這些技術的持續突破，TCE平台有望
成為腫瘤免疫治療領域的重要支柱，為全球患者提供更安全有效的治療選擇。

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管理層討論及分析

化學、生產及控制（「CMC」）
截至2026年6月30日，我們的CMC團隊由130名來自知名生物製藥及製藥公司，且具備工藝開發、生產及質
量管理經驗的專業人員組成，團隊資深成員平均具備約23年經驗。我們的CMC團隊負責為我們的原液及藥品
開發安全、穩健及經濟合理的生產工藝，並確保其質量符合監管規定。
江蘇泰州生產基地。江蘇泰州生產基地主要生產抗體及重組蛋白藥物，擁有抗體藥物產能8,000L、重組蛋白
藥物產能4,000L，製劑生產線可滿足1ml預充式注射器和多個規格西林瓶灌裝。該生產基地於2019年取得由
江蘇省藥品監督管理局頒發的《藥品生產許可證》，於2021年通過歐盟質量授權人（「QP」）審計，抗體生產線
於2022年6月通過中國GMP符合性檢查、2025年6月通過哥倫比亞INVIMA GMP審計、2026年通過PIC/S國家
約旦和巴西的GMP檢查，重組蛋白生產線於2024年5月通過中國GMP符合性檢查，質量控制實驗室於2024年
9月通過CNAS認證。目前生產基地正在進行公司在研品種的臨床用藥生產，及地舒單抗注射液和注射用阿格
司亭α的商業化生產，具有豐富的產業化經驗。截至最後實際可行日期，已完成12個品種的臨床試驗樣品製
備，及3個品種的商業化生產工作。其中原液生產合計159批次（200L培養規模41個批次、500L培養規模4個
批次和2,000L培養規模114個批次，臨床在研品種與上市後商業化擬定生產規模一致），製劑生產合計208批
次，所有批次樣品均檢定合格。
江蘇泰州ADC生產基地。江蘇泰州ADC生產基地佔地逾50,000平方米，擁有2條ADC抗體原液生產線、2條
ADC原液生產線及1條ADC產品製劑生產線。ADC抗體原液生產線一期設計產能為6×2,000L。ADC原液生產
線可實現30L至800L偶聯規模的ADC批量生產，滿足不同類型小分子與批量抗體的偶聯生產需求。截至最後
實際可行日期，ADC車間已完成3個在研品種9MW2821、7MW3711、7MW4911的臨床試驗樣品製備，其中
ADC原液生產17批次，製劑生產18批次，所有批次樣品均檢定合格，標誌著邁威生物的ADC藥物已經實現了
從早期研發、藥學研究和開發到商業化規模的關鍵註冊臨床樣品的生產的全產業鏈佈局。同時，於2025年9
月完成抗體車間機電安裝工程四方驗收，達到6×2,000L的設計產能。現抗體車間已完成所有公用系統、工藝
設備的安裝調試與驗證，具備試生產能力，為大規模抗體藥物戰略佈局奠定基礎。

2026年中報

邁威（上海）生物科技股份有限公司

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管理層討論及分析

上海金山生產基地。項目佔地6.97萬平方米，包括抗體藥物原液生產車間、製劑車間及輔助設施。截至最後
實際可行日期，2條原液生產線、1條西林瓶製劑生產線和1條預充針製劑生產線已全面投入臨床樣品生產；
原液生產線已完成4批500L規模和2批2,000L規模的原液生產，產品檢定合格；預充針製劑生產線已完成5批
培養基模擬灌裝（「APS」）驗證及4批預充針製劑生產，驗證結果及產品檢定均合格。西林瓶製劑生產線已完
成6mL規格的3批次培養基模擬灌裝（APS）驗證、10mL規格的3批次培養基模擬灌裝（APS）驗證，結果均合
格；同時西林瓶製劑生產線已經完成7批製劑生產，產品檢定均合格。目前可提供包括臨床用藥、商業化生產
等不同階段的抗體藥物的原液到無菌製劑的生產。在智能製造建設方面，朗潤邁威信息化項目取得階段性成
果。2026年上半年完成ERP、WMS、WS等核心業務系統的聯動測試，實現關鍵業務流程和系統接口的貫通驗
證，各系統運行穩定。目前正有序推進核心系統集成驗證，為生產運營數字化、智能化提供有力支撐。金山
生產基地已於2025年1月獲得了歐盟QP審計的符合性聲明。

商業化、營銷及業務拓展
公司深入拓展國內市場，增加商業化銷售收入。2026 年上半年，公司藥品銷售收入為人民幣211.7百萬元，
較上年同期人民幣100.8 百萬元增長人民幣110.9 百萬元，同比增長110.1%，主要系藥品君邁康 ® 的MAH於
2025年7月獲批由上海君實生物醫藥科技股份有限公司（「君實」）變更為邁威生物，2025年四季度起由邁威生
物進行開票銷售，2026年上半年邁威生物開票的君邁康 ® 國內藥品銷售收入為人民幣75.4百萬元。
公司於2026 年上半年搭建專注於眼科全領域的專業化商業化平台邁威視，致力於成為中國備受信賴的眼科
創新生態引領者，並於2026年6月與國內領先的眼科小分子藥物研發企業維眸生物科技（浙江）股份有限公司
（「維眸生物」）達成戰略合作，未來將充分發揮各自核心優勢，持續深耕眼科炎症與眼免疫治療領域，推動更
多優質眼科藥物落地臨床、服務患者。
在中國境外，我們的商業化及業務拓展工作針對新興市場及發達國家，利用產品直銷等策略，為本地化灌裝
供應活性成分及為本地化生產提供細胞株。我們已就核心產品及其他創新管線產品組建一支專業全球業務拓
展團隊，主要負責發達國家的許可安排。我們旨在探索及增加創新藥的海外許可機會，使其市場價值最大
化。我們還戰略性地選擇通過許可及合作安排在新興市場商業化部分相對成熟的產品（如生物類似藥）。

邁威（上海）生物科技股份有限公司

2026年中報

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管理層討論及分析

目前，針對君邁康 ®，公司已與印尼、新加坡、巴基斯坦、菲律賓、埃及、摩洛哥、阿根廷等17個國家簽署
正式合作協議，並已向印尼、巴基斯坦、約旦、祕魯等6個國家遞交了註冊申請文件，且已獲得印尼食品藥品
監督管理局批准，其他國家註冊申請亦在準備中。針對邁利舒 ®，公司已與巴西、哥倫比亞、印尼、新加坡、
巴基斯坦、泰國、埃及、祕魯、沙特阿拉伯等33個國家簽署正式合作協議，並已向約旦、埃及、巴西等8個
國家遞交了註冊申請文件，且已獲得巴基斯坦藥品監督管理局批准，其他國家註冊申請亦在準備中。針對邁
衛健 ®，公司已與巴西、哥倫比亞、新加坡、巴基斯坦、泰國、埃及、祕魯、沙特阿拉伯等33個國家簽署正
式合作協議，並已向約旦、埃及、巴西等8個國家遞交了註冊申請文件，且已獲得巴基斯坦藥品監督管理局批
准，其他國家註冊申請亦在準備中。截至最後實際可行日期，公司已完成覆蓋海外市場數十個國家的正式合
作協議的簽署。
面向歐美等發達國家或境內頭部藥企，我們通過對外許可授權和NewCo等合作模式，推進公司產品、特別是
創新品種的廣泛合作。該項工作由商務拓展部承接，核心戰略目標是基於公司高效的創新發現體系和強大的
開發能力、致力於公司研發管線的價值最大化、全球化。目前，公司正與多家國際醫藥企業巨頭就多款產品
進行多輪商業談判，涵蓋了從數據交換到商務條款討論的不同階段。
公司持續活躍於國內外頂級商務拓展會議、行業峯會及前沿學術會議，公司積極參與摩根大通醫療健康大
會、BIO國際生物技術大會、China Bio、Bio Europe等行業盛會，通過主題演講、項目路演、一對一會議約
見等多種形式，與百餘家海外、境內企業建立聯繫，將會議資源轉化為實質性的合作線索與談判進展。這些
頂級會議已成為公司鏈接全球創新網絡、提升國際品牌認知度、加速產品管線海外授權落地的關鍵戰略節
點。通過深度洞察全球行業趨勢、精準對接潛在合作夥伴並建立戰略互信，不斷強化自身技術研發的持續競
爭力與行業影響力，為產品管線的國際化推廣提供更加堅實的戰略支撐與資源保障。

2026年中報

邁威（上海）生物科技股份有限公司

31
管理層討論及分析

目前，公司已有多個創新品種，面向發達國家達成對外許可，其中9MW3011（ 全球唯一用於真性紅細胞增多
症治療的靶向TMPRSS6單抗）與Disc訂立獨家許可協議，9MW3811（ 全球第一梯隊、面向巨大的纖維化與抗
衰老相關的臨床需求的靶向IL-11單抗）與Calico訂立獨家許可協議，2MW7141（潛在全球首款採用非LNP遞送
系統的雙靶點siRNA分子）與Aditum Bio達成New Co合作，以上對外授權累計金額最高可達20億美金。公司
仍持續探索ADC、TCE及其他創新產品的BD機會，如差異化創新的靶向CDH17 ADC、靶向LILRB4/CD3 TCE雙
抗、靶向ST2單抗等。

知識產權
報告期內，本公司新申請57項發明專利，新獲授權21項發明專利，其中15項為中國授權發明專利、6項為國
家階段授權發明專利。截至2026年6月30日，本公司共有387項發明專利申請，包括276項在審申請及111項
授權專利（其中72項為中國授權發明專利、38項為境外授權發明專利、1項為中國台灣地區授權發明專利）。
報告期新增

累計數量

申請數（個）

獲得數（個）

申請數（個）

獲得數（個）

發明專利
實用新型專利
外觀設計專利
軟件著作權
其他

57
1
0
0
12

21
5
0
0
26

387
54
6
2
333

111
45
6
2
309

合計

70

52

782

473

未來及前景
展望未來，本公司將繼續秉持「探索生命，惠及健康」的初心使命，致力於以創新驅動為動力，以專業人才為
核心，通過源頭創新滿足臨床需求推動商業快速轉化，專注於腫瘤和年齡相關疾病，如免疫、眼科、骨科等
領域。為此，我們將加速核心產品試驗階段進程，目前公司核心自研的Nectin-4 靶向ADC產品9MW2821 臨
床進度位居國內首位、全球第二，亦是全球首個推進至宮頸癌III期註冊臨床的同靶點藥物，目前尿路上皮癌
單藥、聯合免疫治療及宮頸癌三項核心適應症正處於III期臨床的關鍵攻堅階段。公司將持續傾斜研發資源，
高效推進各項臨床研究與註冊申報籌備工作，計劃於2026年內完成III期臨床期中分析並隨後開展上市申報溝
通，力爭盡早將這款具備療效與安全性差異化優勢的創新療法帶給國內廣大實體瘤患者。

邁威（上海）生物科技股份有限公司

2026年中報

32
管理層討論及分析

我們以管線轉化為核心目標。
在攻堅核心產品臨床開發的同時，公司將加快推進報產品種的註冊審評相關工作，以及已進入臨床階段品種
的受試者入組與數據讀出工作，確保申報資料高質量提交及臨床進度符合預期，並持續開展TCE、ADC及差
異化單抗等創新分子發現與臨床前研究。在自主研發的基礎上，我們還將佈局加強與全球優秀醫藥企業開展
商業化合作，不斷拓展全球化商業版圖。

III.

財務回顧
概覽
我們是一家以藥物研發方面的創新能力以及從藥物發現至商業化銷售的端到端運營能力而聞名的中國製藥公
司。我們的管線專注於腫瘤和年齡相關疾病，該等疾病在全球構成重大健康風險且存在未被滿足的臨床需
求。我們共有15個核心品種處於臨床研究或上市階段，涵蓋11款創新藥與4款生物類似藥，重點佈局免疫、
眼科、骨科等領域。其中，4個品種已獲批上市，1個品種的國產藥品註冊上市許可申請處於審評階段，2個
品種處於III期關鍵註冊臨床試驗階段，其餘品種分別處於不同臨床研究階段。
以下討論乃基於本報告別處所載的財務資料及附註，並應與其一併閱讀。

期內虧損
截至2026 年6 月30 日止六個月，淨虧損為人民幣524.2 百萬元，較截至2025 年6 月30 日止六個月的人民幣
552.2百萬元減少人民幣28.0百萬元。該減少主要由於中期簡明綜合損益及其他全面收益表相關項目所載因
素。

收入
我們的收入由截至2025年6月30日止六個月約人民幣101.1百萬元增加209.1%至截至2026年6月30日止六個
月約人民幣312.5百萬元。該增加主要由於Kalexo及Disc的對外授權收入增加，以及君邁康 ® 的藥品的銷售收
入增加導致收入增加所致。

2026年中報

邁威（上海）生物科技股份有限公司

33
管理層討論及分析

下表載列所示期間按性質劃分的收入明細。
截至6月30日止六個月
2026年
（未經審核）

2025年
（未經審核）

（人民幣千元，百分比除外）
產品銷售
對外授權及提供服務

212,597
99,856

68.0%
32.0%

101,004
94

99.9%
0.1%

總計

312,453

100.0%

101,098

100.0%

銷售成本
我們的銷售成本由截至2025年6月30日止六個月約人民幣22.1百萬元增加246.6%至截至2026年6月30日止六
個月約人民幣76.6百萬元。該增加主要由於君邁康 ® 的銷量增加。

毛利
我們的毛利由截至2025年6月30日止六個月約人民幣79.0百萬元增加198.6%至截至2026年6月30日止六個月
約人民幣235.9百萬元。該增加主要由於君邁康 ® 銷量增加導致毛利上升，以及報告期內Kalexo及Disc對外授
權業務的毛利增加。

其他收入及收益
我們的其他收入及收益由截至2025年6月30日止六個月約人民幣31.5百萬元減少64.8%至截至2026年6月30日
止六個月約人民幣11.1百萬元。該減少主要由於政府補助減少人民幣21.5百萬元。

銷售及分銷開支
我們的銷售及分銷開支由截至2025年6月30日止六個月約人民幣102.2百萬元增加36.4%至截至2026年6月30
日止六個月約人民幣139.4百萬元。該增加主要由於加大產品商業化力度導致營銷費用由截至2025年6月30日
止六個月的人民幣39.0百萬元增加至截至2026年6月30日止六個月的人民幣61.9百萬元。

研發成本
截至2026年6月30日止六個月，研發成本為人民幣431.4百萬元，較截至2025年6月30日止六個月的人民幣
392.1百萬元增加人民幣39.3百萬元，主要由於實驗室材料成本增加人民幣14.8百萬元，以及折舊及攤銷開支
增加人民幣18.6百萬元。

邁威（上海）生物科技股份有限公司

2026年中報

34
管理層討論及分析

行政開支
我們的行政開支由截至2025年6月30日止六個月約人民幣119.0百萬元減少9.0%至截至2026年6月30日止六
個月約人民幣108.3百萬元。該減少主要由於折舊及攤銷開支減少人民幣23.2百萬元、薪金及福利增加人民幣
5.1百萬元，以及諮詢費增加人民幣4.5百萬元。

其他開支
我們的其他開支由截至2025年6月30日止六個月約人民幣10.0百萬元增加121.0%至截至2026年6月30日止六
個月約人民幣22.1百萬元。該增加主要由於匯兌虧損增加。

金融資產減值虧損及減值虧損撥回淨額
截至2026年6月30日止六個月，我們錄得金融資產減值虧損人民幣3.7百萬元，主要由於就新應收若干客戶款
項作出撥備。
截至2025年6月30日止六個月，我們錄得金融資產減值虧損撥回人民幣3.2百萬元，主要歸因於收回過去期間
應收若干客戶款項。

財務成本
我們的財務成本由截至2025年6月30日止六個月約人民幣39.3百萬元增加52.2%至截至2026年6月30日止六個
月約人民幣59.8百萬元。該增加主要由於回購義務利息增加人民幣7.2百萬元、公司債券利息增加人民幣9.5
百萬元。

流動資金及資本資源
我們監控現金及現金等價物，並將其維持在我們認為足以為運營提供資金及減輕現金流量波動影響的水平。
我們的現金以人民幣、美元及港幣計值。此外，我們監察借款的使用情況並根據我們的實際業務需求於借款
到期時不時評估是否選擇延長借款期限。於報告期間，我們依賴作為流動資金主要來源的股權融資、債務融
資及藥品銷售。
於報告期內，我們的經營活動的現金流量為負數，而我們的經營現金流出絕大部分來自我們的研發及行政活
動。我們的經營活動於2025年上半年及2026年上半年分別動用現金人民幣33.9百萬元及人民幣508.9百萬元。
我們預期透過推出及商業化我們的產品、與第三方的合作安排以及加強成本控制能力及營運效率，從而產生
更多來自經營活動的現金流量。為實現我們的研發目標，我們最終將需要額外資金來源，但我們無法保證能
夠獲得額外資金來源。

2026年中報

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管理層討論及分析

下表載列我們於所示期間的現金流量：
截至6月30日止六個月
2026年
人民幣千元
（未經審核）

2025年
人民幣千元
（未經審核）

經營活動所用現金淨額
投資活動所用現金淨額
融資活動所得現金淨額

(508,938)
(140,734)
1,434,501

(33,923)
(100,226)
295,364

現金及現金等價物增加淨額
期初現金及現金等價物
外匯匯率變動的影響淨額

784,829
1,526,339
(17,236)

161,215
1,227,566
(154)

期末現金及現金等價物

2,293,932

1,388,627

經營活動所用現金淨額
截至2026年6月30日止六個月，我們的經營活動所用現金淨額為人民幣508.9百萬元，主要歸因於除稅前虧損
人民幣523.8百萬元，主要就以下各項作出調整：(i)物業、廠房及設備折舊人民幣90.9百萬元，(ii)財務成本人
民幣59.8百萬元，(iii)其他應付款項及應計費用減少人民幣47.3百萬元，及(iv)貿易應付款項減少人民幣85.3百
萬元。
截至2025年6月30日止六個月，我們的經營活動所用現金淨額為人民幣33.9百萬元，主要歸因於除稅前虧損
人民幣552.2百萬元，主要就以下各項作出調整：(i)物業、廠房及設備折舊人民幣89.5百萬元，(ii)財務成本人
民幣39.3百萬元，(iii)其他應付款項及應計費用增加人民幣368.6百萬元，及(iv)貿易應收款項增加人民幣18.8
百萬元。

投資活動所用現金淨額
截至2026年6月30日止六個月，我們的投資活動所用現金淨額為人民幣140.7百萬元，主要歸因於購買物業、
廠房及設備人民幣61.6百萬元及購買按公允價值計入損益計量的金融資產人民幣142.1百萬元，部分被贖回按
公允價值計入損益計量的金融資產所得款項人民幣78.6百萬元所抵銷。
截至2025年6月30日止六個月，我們的投資活動所用現金淨額為人民幣100.2百萬元，主要歸因於購買物業、
廠房及設備人民幣87.2百萬元、購買按公允價值計入損益計量的金融資產人民幣38.1百萬元及對聯營公司的
投資人民幣17.1百萬元，部分被贖回按公允價值計入損益計量的金融資產所得款項人民幣41.9百萬元所抵銷。

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2026年中報

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管理層討論及分析

融資活動所得現金淨額
截至2026年6月30日止六個月，我們的融資活動所得現金淨額為人民幣1,434.5百萬元，主要歸因於我們的新
增銀行借款人民幣1,095.3百萬元、金融機構貸款人民幣100.0百萬元及普通股發行所得款項人民幣1,095.2百
萬元，部分被償還銀行借款人民幣798.7百萬元所抵銷。
截至2025年6月30日止六個月，我們的融資活動所得現金淨額為人民幣295.4百萬元，主要歸因於我們的新增
銀行借款人民幣867.1百萬元、金融機構貸款人民幣100.0百萬元及非控股股東注資人民幣200.0百萬元，部分
被償還銀行借款人民幣792.5百萬元所抵銷。

現金及現金等價物
關於我們的現金狀況，請參閱上文「流動資金及資本資源」分節。

借款及資產負債比率
本集團於2026 年6 月30 日的總借款（包括計息借款）為人民幣2,568.0 百萬元，較2025 年12 月31 日的人民幣
2,275.6百萬元增加人民幣292.4百萬元。
於2026年6月30日及2025年12月31日，本集團的銀行借款分別約為人民幣856.3百萬元及人民幣882.4百萬
元，並以我們的專利質押作抵押，或以我們的樓宇、在建工程或土地按揭作抵押。本集團的長期銀行借款期
限為2年至10年。截至2026年6月30日，我們的未償還貸款以人民幣計值。
借款的公允價值與其賬面值相若，因為貼現影響並不重大。
於2026年6月30日，我們計息借款的實際利率介乎1.95%至3.70%。
我們的租賃負債維持相近水平，於2026年6月30日為人民幣106.2百萬元，於2025年12月31日為人民幣148.7
百萬元。
本集團於2026年6月30日的資產負債比率（以借款及租賃負債總和除以權益總額計算）為253.6%，較2025年
12月31日的454.8%減少201.23%。

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管理層討論及分析

重大投資
於2026年6月30日，我們並無持有任何價值佔本集團總資產5%或以上的重大投資（包括對被投資公司的任何
投資）。

重大收購及出售
於截至2026年6月30日止六個月，我們並無進行任何子公司、聯營公司及合營企業的重大收購或出售。

外匯風險
本集團在美利堅合眾國及中華人民共和國設有營運實體。我們若干銀行結餘、貿易應收款項、其他應收款
項、其他金融資產、貿易應付款項、其他應付款項、租賃負債及其他金融負債以外幣計值，並面臨外幣風險。
於2026年6月30日，本集團並無外匯對沖工具及外幣對沖政策。然而，我們的管理層持續監察經濟形勢及本
集團的外匯風險敞口，並將在日後有需要時考慮適當的對沖措施。

資本開支
於截至2026年6月30日止六個月，本集團的資本開支總額約為人民幣61.6百萬元，主要用於購買物業、廠房
及設備項目。

資產抵押
於2026 年6 月30 日，本集團用於銀行及其他借款的已質押 ╱ 抵押資產的賬面淨值為人民幣 1,636.0 百萬元
（2025年12月31日：人民幣1,564.1百萬元），佔本集團總資產約30.9%（2025年12月31日：34.3%）。該等資
產主要包括物業、廠房及設備等。

或然負債
於2026年6月30日，本集團並無任何重大或然負債。我們確認，截至最後實際可行日期，我們的或然負債並
無重大變動或安排。

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2026年中報

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管理層討論及分析

僱員及薪酬政策
截至2026年6月30日，我們共有1,356名僱員，而2025年12月31日則為1,325名僱員。
我們與僱員訂立個別僱傭合同，涵蓋薪資、獎金、僱員福利、工作場所安全、保密及不競爭、工作成果分配
條款及終止理由。為維持我們僱員的技能水平，我們提供繼續教育及培訓計劃，以提高其技術、專業或管理
技能。我們亦為僱員提供培訓計劃，以確保其了解及遵守我們的政策及程序。此外，我們為僱員（特別是關
鍵僱員）提供各種激勵及福利，包括具競爭力的薪資、獎金及以股份為基礎的付款。
於報告期間及截至最後實際可行日期，我們並無經歷任何對業務造成重大影響的罷工、勞資糾紛或工業行
動。我們相信，我們在招聘營運人員方面並無遇到任何重大困難。
我們的僱員薪酬包括薪資、獎金、公積金、社會保險供款及其他福利金。我們已根據適用法律法規為僱員繳
納社會保障保險基金（包括養老保險、醫療保險、工傷保險、失業保險及生育保險）及住房公積金。我們於報
告期間及截至最後實際可行日期，已在所有重大方面遵守中國法律法規下適用於我們的法定社會保障保險基
金及住房公積金義務。
我們已採取並備有一系列的規則、標準操作程序及措施，以維護僱員的健康及安全環境。我們執行安全指
南，列出有關潛在安全隱患和程序的信息。我們要求僱員參加安全培訓，以熟悉相關的安全規則及程序。同
時，我們亦已制定相關政策並採取相關措施，以確保工作環境的衛生及僱員的健康。
我們亦已採納兩項股份計劃。於2020年6月19日，本公司採納了首次公開發售前股權激勵計劃（於2024年12
月31日經本公司股東決議修訂），該計劃不受上市規則第17章規限，因為其不涉及本公司於上市後進一步授
出獎勵。詳情請參閱本報告「XIV. 股份激勵計劃 － 首次公開發售前股權激勵計劃」一段。於2023年9月25日，
本公司亦採納邁威美國股權激勵計劃，該計劃不受上市規則第17章規限，因為邁威美國並非本公司的主要子
公司（定義見上市規則第17章）。詳情請參閱招股章程「附錄四 － 法定及一般資料 － 邁威美國股權激勵計劃」
一段。

重大投資及資本資產的未來計劃
除本報告所披露者外，截至最後實際可行日期，我們並無授權任何重大投資或收購資本資產計劃。

2026年中報

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管理層討論及分析

IV.

主要風險及不確定性
我們認為，我們的營運涉及若干風險，其中許多風險非我們所能控制。我們面臨的部分主要風險包括：
•

創新藥物的開發耗時且費用高昂，且結果具有不確定性。倘我們未能完成開發及商業化新產品（包括我
們的核心產品），我們的業務前景可能會受到不利影響。

•

部分管線面臨來自現有藥物及開發中候選藥物的激烈競爭。

•

我們可能會將有限的資源分配至尋求某種候選藥物或適應症，而導致未能投入到之後被證明利潤更高或
更有可能成功的候選藥物或適應症。

•

我們在研發方面投入了大量的人力和資本資源，以開發候選藥物，但我們無法保證相關努力將能夠取得
成功。

邁威（上海）生物科技股份有限公司

2026年中報

40

企業管治及其他資料

I.

中期股息
截至2026年6月30日止六個月，公司決定不向股東派付中期股息。

II.

遵守證券交易的標準守則
本公司已採納香港聯交所證券上市規則（「上市規則」）附錄C3所載上市發行人董事進行證券交易的標準守則
（「標準守則」）。本公司已向全體董事作出具體查詢，董事已確認彼等於自2026年4月28日（「上市日期」）起至
本報告日期止期間已遵守標準守則。
本公司可能知悉本公司內幕消息的僱員，亦須遵守有關證券交易的標準守則。於報告期內，本公司並無發現
任何僱員違反標準守則的情況。

III.

遵守企業管治守則
本公司深知良好的企業管治對提升本公司的管理水平及保障股東整體利益至為重要。本公司已採納並應用上
市規則附錄C1所載之企業管治守則（「企業管治守則」）第二部分載列的原則及守則條文為其本身的企業管治常
規守則。
自上市日期起至本報告日期止期間，除下段所述守則條文第C.2.1條外，本公司已遵守企業管治守則所載的所
有適用守則條文。董事會將繼續檢討及監察本公司的企業管治常規守則，致力維持高標準的企業管治水平。
根據企業管治守則第二部分第C.2.1 段，聯交所上市公司預期將遵守但可選擇偏離董事長與首席執行官之間
的職責應分開且不應由同一人履行的規定。我們並無將董事長與首席執行官的職責分開，劉大濤博士（「劉博
士」）目前擔任本公司董事長兼總經理。劉博士自2023年6月起擔任董事長。其在本集團的業務運營及管理方
面擁有豐富經驗。董事會認為，鑒於其上述經驗、個人履歷及在本公司的職務，劉博士作為總經理對我們的
業務有廣泛了解，是最適合識別董事會戰略機遇及重點的董事。董事會還認為，將董事長與總經理的職務交
由同一人擔任具有以下益處：(i)確保本集團領導層的一致性，(ii)使董事會能夠更有效、更高效地制定整體戰
略規劃並執行戰略計劃，及(iii)促進本集團管理層與董事會之間的信息交流。董事會認為，現行安排的權力和
職權平衡不會受到影響，且此安排將使本公司能夠迅速有效地作出和執行決策。董事會將繼續審查，並考慮
在適當的時候，結合本集團的整體情況，將本公司董事長和總經理的職責分開。

2026年中報

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41
企業管治及其他資料

IV.

審計委員會
我們已成立審計委員會，並根據上市規則第3.21條及企業管治守則第二部分第D.3段制定其書面職權範圍。審
計委員會由三名董事組成，即秦正余先生、周睿先生及李凡女士。秦正余先生持有上市規則第3.10(2)條及第
3.21條所規定的適當專業資格，並擔任審計委員會主席。審計委員會的主要職責為（其中包括）：(i)監督及評
估外部審計工作，(ii)就外部審計機構的委任、重新委任、更換及罷免向董事會提供建議，(iii)指導及監督內部
審計工作及其實施，(iv)審核本公司的財務資料及監督本公司的財務匯報制度、風險管理及內部控制制度，及
(v)處理相關法律、法規、規章、規範性文件、組織章程細則、工作細則、公司股票上市地上市規則中所涉及
或董事會授權的其他事宜。
審計委員會已審閱並認同本集團採納的會計原則及慣例，並已與管理層討論有關內部控制及財務匯報的事
宜，包括審閱本集團截至2026年6月30日止六個月的未經審計簡明綜合中期財務業績。審計委員會認為，截
至2026年6月30日止六個月的中期財務業績符合相關會計準則、規則及法規，且已妥為作出適當披露。

V.

上市規則第13.51B(1)條項下董事及最高行政人員的資料變更
於2026年6月18日，胡會國先生因任期屆滿而卸任執行董事，吳玉峰先生因任期屆滿而卸任非執行董事，許
青博士及趙倩博士因任期屆滿而卸任獨立非執行董事。同日，於臨時股東會上通過選任唐春山先生、劉大濤
博士、武海博士及華俊先生為執行董事，以及秦正余先生、周睿先生、李凡女士及王芳女士為獨立非執行董
事，並於工會委員會通過選任桂勳博士為職工代表董事。詳情請參閱本公司日期為2026年6月18日的公告。
除上文所披露者外，自本招股章程日期起至本報告日期止，概無上市規則第13.51B(1)條項下須予披露有關董
事及高級管理層的資料變更。

邁威（上海）生物科技股份有限公司

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企業管治及其他資料

VI.

董事及最高行政人員於本公司及其相聯法團的股份、相關股份及債權證中的權益
及淡倉
除下文所披露者外，截至2026年6月30日，據董事所知，概無董事及最高行政人員於本公司或其任何相聯法
團（定義見證券及期貨條例第XV部）的股份、相關股份或債權證中擁有(i)根據證券及期貨條例第XV部第7及第
8分部須知會我們及聯交所的任何權益及淡倉（包括根據證券及期貨條例的有關條文被當作或視為擁有的權益
及淡倉），或(ii)根據證券及期貨條例第352條須登記於該條所指登記冊的任何權益及淡倉，或(iii)根據上市規
則所載上市發行人董事進行證券交易的標準守則須知會我們及聯交所的任何權益及淡倉：

股份數目 (1)

截至2026年
6月30日
於A股 ╱H股中的
概約持股百分比 (2)

截至2026年
6月30日
佔股本總額的
概約持股百分比 (2)

姓名

身份 ╱ 權益性質

唐春山先生

受控法團權益

169,360,000(3) 股A股 (L)
1,983,800(4) 股H股 (L)

42.38%
4.21%

37.91%
0.44%

劉大濤博士

實益擁有人
實益擁有人 (5)

15,100,000股A股 (L)
6,360,000股A股 (L)

3.78%
1.59%

3.38%
1.42%

桂勛博士

實益擁有人 (6)

500,000股A股(L)

0.13%

0.11%

(1)

「L」字母代表該人士於股份中的好倉。

(2)

計算依據為399,600,000股A股及47,130,200股H股的總數。

(3)

截至2026年6月30日，唐春山先生(i)作為有限合夥人於朗潤（深圳）股權投資基金企業（有限合夥）
（「朗潤股權」）直接擁有約79.92%
的合夥權益及作為普通合夥人透過深圳市朗潤投資諮詢管理有限公司（「朗潤投資諮詢」）於朗潤股權間接擁有0.10%的合夥權益，而
朗潤股權實益擁有140,560,000股A股；(ii)作為普通合夥人於寧波梅山保稅港區中駿建隆投資合夥企業（有限合夥）
（「中駿建隆」）直
接擁有約2.12%的合夥權益，而中駿建隆實益擁有20,000,000股A股；(iii)作為普通合夥人於寧波梅山保稅港區真珠投資管理合夥企
業（有限合夥）
（「真珠投資」）直接擁有約10.56%的合夥權益，而真珠投資實益擁有6,800,000股A股；及(iv)於朗潤投資諮詢直接擁有
88.30%的股權，而朗潤投資諮詢實益擁有2,000,000股A股。根據證券及期貨條例，唐春山先生被視為於朗潤股權、中駿建隆、真
珠投資及朗潤投資諮詢持有的股份中擁有權益。

(4)

指昌榮國際有限公司通過其作為基石投資者進行的投資認購的1,983,800股H股。昌榮國際有限公司由唐春山先生全資擁有。

(5)

指劉大濤博士透過寧波梅山保稅港區中駿建隆投資合夥企業（有限合夥）間接持有的本公司6,360,000股A股。

(6)

指由桂勛博士透過寧波梅山保稅港區真珠投資管理合夥企業（有限合夥）間接持有的本公司500,000股A股。

2026年中報

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企業管治及其他資料

VII. 主要股東的權益及淡倉
截至2026年6月30日，就本公司及董事經作出合理查詢後所知，下列人士（本公司董事及最高行政人員除外，
其權益已於上文披露）於股份或相關股份中擁有根據證券及期貨條例第XV部第2及第3分部條文須向本公司披
露，並須登入本公司根據證券及期貨條例第336條須存置的登記冊的權益或淡倉：

股份數目 (1)

截至2026年
6月30日
於A股 ╱H股中的
概約持股百分比 (2)

截至2026年
6月30日
佔股本總額的
概約持股百分比 (2)

姓名

身份 ╱ 權益性質

陳姍娜女士 (3)

配偶權益

169,360,000股A股 (L)
1,983,800股H股 (L)

42.38%
4.21%

37.91%
0.44%

朗潤股權

實益擁有人

140,560,000股A股 (L)

35.18%

31.46%

朗潤投資諮詢 (4)

實益擁有人
受控法團權益

2,000,000股A股 (L)
140,560,000(4) 股A股 (L)

0.50%
35.18%

0.45%
31.46%

中駿建隆

實益擁有人

20,000,000股A股 (L)

5.01%

4.48%

附註：
(1)

「L」字母代表該人士於股份中的好倉。

(2)

計算依據為399,600,000股A股及47,130,200股H股的總數。

(3)

陳姍娜女士為唐春山先生的配偶。根據證券及期貨條例，陳姍娜女士被視為於唐春山先生被視為擁有權益的股份中擁有權益。

(4)

截至2026年6月30日，朗潤投資諮詢作為普通合夥人直接於朗潤股權擁有約0.10%的合夥權益，而朗潤股權實益擁有140,560,000股
A股。根據證券及期貨條例，朗潤投資諮詢被視為於朗潤股權持有的股份中擁有權益。

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企業管治及其他資料

除上文所披露者外及據董事所深知，於2026年6月30日，本公司並不知悉任何其他人士（除本公司董事或最高
行政人員外）於股份或相關股份中擁有根據證券及期貨條例第336條本公司須備存的登記冊所記錄的權益或淡
倉。

VIII. 董事收購股份或債權證的權利
除本報告披露者外，截至2026年6月30日，概無董事或其各自的配偶或18歲以下子女獲授任何可藉收購本公
司股份或債權證方式獲利的權利或已行使任何該等權利。本公司及其任何子公司並非任何安排的訂約方，而
該等安排令董事或其各自的配偶或18歲以下子女可自任何其他法團獲得該等權利。

IX.

法律訴訟
截至2026年6月30日，據本公司所知，本公司及其附屬公司並無牽涉任何重大訴訟或仲裁，本公司概無任何
未決或面臨威脅或威脅提出的重大訴訟或索償。

X.

購買、出售或贖回本公司上市證券
於報告期內，本公司及其任何子公司概並無購買、出售或贖回本公司任何上市證券（包括出售庫存股份（定義
見上市規則））。
截至2026年6月30日，本公司持有1,192,369股庫存股份（定義見上市規則），亦無已回購但尚待註銷的股份。
該等庫存股份將用於員工持股計劃或股權激勵。倘回購股份於股份回購完成後三年內未用於前述用途，則未
獲動用的已回購股份將依據相關法律法規予以註銷，且該註銷須遵守組織章程細則、中國適用法律及上市規
則。

XI.

股本
於報告期內，本公司股本的變動詳情載於本報告綜合財務報表附註10。

XII. 所得款項用途
全球發售所得款項用途
本公司股份於2026年4月28日在聯交所上市，合共發行47,130,200股發售股份，全球發售所得款項淨額約為
人民幣1,047.6百萬元（相當於約1,197.1百萬港元）。上市所得款項淨額（按實際所得款項淨額按比例調整）已
經及將會按照招股章程所載用途使用。先前於招股章程所披露的所得款項淨額的擬定用途並無變動，具體如
下：
•

約56.8%，或人民幣595.0百萬元（相當於約679.8百萬港元），將用於核心產品9MW2821針對多種適應
症不同階段的臨床開發試驗。

2026年中報

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企業管治及其他資料

•

約17.7%，或人民幣185.4百萬元（相當於約211.9百萬港元），將用於針對具有大量臨床需求的腫瘤和
年齡相關疾病的其他管線產品的研發。

•

約15.5%，或人民幣162.4百萬元（相當於約185.6百萬港元），將用於商業化目的。

•

約10.0%，或人民幣104.8百萬元（相當於約119.8百萬港元），將用於營運資金及其他一般公司用途。

全球發售所得款項淨額已按照招股章程所載用途動用。下表載列所得款項淨額的動用情況及截至2026年6月
30日的實際使用情況：

所得款項用途

百分比
(%)

所得款項
淨額的
計劃分配
（人民幣
百萬元）

自上市
日期起至
2026年
6月30日的
已動用金額
（人民幣
百萬元）

於2026年 未動用所得款項
6月30日的 淨額的預期動用
未動用金額 時間表 (1)
（人民幣
百萬元）

核心產品9MW2821的
臨床開發試驗
針對腫瘤和年齡相關
疾病的其他管線
產品的研發
用於商業化目的

56.8

595.0

0.2

594.8

17.7

185.4

7.4

178.0

15.5

162.4

12.6

149.8

營運資金及其他
一般公司用途 (2)

10.0

104.8

98.5

6.3

100.0

1,047.6

118.7

928.9

總計

於2029年12月31日
或之前
於2028年12月31日
或之前
於2028年12月31日
或之前
於2027年12月31日
或之前

(1)

未動用所得款項的預期動用時間表乃本集團根據預期市場狀況作出的最佳估計，該時間表可能因應現時及未來的市場發展而有所變
動。

(2)

營運資金及其他一般公司用途，包括但不限於償還貸款、支付供應商款項及結算日常經營開支。

上述港元金額乃按2026年4月28日人民幣1元兌1.1427港元的匯率換算。

邁威（上海）生物科技股份有限公司

2026年中報

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企業管治及其他資料

A股發行所得款項用途
根據中國證監會核准的「關於同意邁威（上海）生物科技股份有限公司首次公開發行股票註冊的批覆」
（證監
許可[2021]3859 號），本公司獲准向公眾公開發行99,900,000 股人民幣普通股（A股）；此次A股實際發行價
為每股人民幣34.80元。本公司透過向社會公開發行人民幣普通股99,900,000股，籌集所得款項總額人民幣
3,476.5百萬元。經扣除發行開支人民幣173.1百萬元，所得款項淨額約為人民幣3,303.4百萬元。
根據A股招股說明書所載的所得款項用途說明，本公司A股發行所得的全部款項，扣除發行費用後，將用於(i)
年產1,000kg抗體產業化建設項目；(ii)抗體藥物研發；及(iii)補充營運資金。上述所得款項已於2022年1月10
日轉入本公司指定賬戶，且資金到位情況已獲安永華明會計師事務所（特殊普通合夥）驗證，其已出具相關驗
資報告。
於2024年4月8日舉行的股東週年大會上，股東決議案獲通過，將A股發行所得款項用途變更為(i)年產1,000kg
抗體產業化建設項目；(ii)抗體藥物中試產業化項目I期；(iii)抗體藥物研發；及(iv)補充營運資金。
截至2026年6月30日，本集團已動用A股發行所得款項淨額作以下用途：
報告期末
報告期內
已動用所得
已動用所得
所得款項
款項淨額
款項淨額
建議投資金額
人民幣百萬元 人民幣百萬元 人民幣百萬元
年產1,000kg抗體
產業化建設項目 (2)
抗體藥物中試產業化
項目I期
抗體藥物研發
補充營運資金
總計

報告期末
未動用
所得款項 預期時間表 (1)
人民幣百萬元

580.0

37.3

347.6

232.4

420.0

32.0

278.7

141.3

1,523.4

156.5

1,257.0

266.4

780.0

0.0

780.0

0.0

3,303.4

225.8

2,663.3

640.1

2026年中報

於2029年12月31日
或之前
於2026年12月31日
或之前
於2029年12月31日
或之前
不適用

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企業管治及其他資料

(1)

動用未動用所得款項的預期時間表指本集團根據預期市況作出的最佳估計，且可能因應當前及未來市場發展而有所變動。

(2)

本公司於2025年3月30日分別召開第二屆董事會第十七次會議、第二屆監事會第十六次會議及第二屆董事會獨立董事專門會議第
三次會議，並於2025年4月21日召開了2024年年度股東大會，審議通過了《關於部分募集資金投資項目結項並將節餘募集資金永久
補充流動資金的議案》，同意本公司將首次公開發行股票募集資金投資項目（以下簡稱「募投項目」）
「年產1,000kg抗體產業化建設項
目」予以結項，並將節餘募集資金中的人民幣189.4百萬元用於永久補充流動資金。募投項目應付未付的採購尾款、質保金和鋪底流
動資金（含後續利息收入）將繼續保留在募集資金專戶，按照中國證券監督管理委員會、上海證券交易所發佈的相關規範性文件及
本公司規範運作制度的要求，繼續對募集資金進行專戶管理，並按計劃將在募投項目未來運行過程中陸續支付。

A股發行所得款項淨額已根據A股招股說明書所載的用途動用。所得款項淨額的擬定用途與先前於A股招股說
明書所披露者概無變動。

XIII. 報告期結束後事項
於本報告日期，本集團於報告期後概無發生任何須予額外披露或調整的重大事項。

XIV. 根據上市規則的持續披露責任
本公司概無任何上市規則第13.20條、第13.21條及第13.22條項下的披露責任。

XV. 股份激勵計劃
於上市日期之前，本公司已於2020年6月19日採納一項股份激勵計劃，即首次公開發售前股權激勵計劃（經本
公司股東決議案於2024年12月31日修訂）。首次公開發售前股權激勵計劃不受上市規則第17章所規限，因其
不涉及本公司於上市後進一步授予獎勵。

首次公開發售前股權激勵計劃
目的
首次公開發售前股權激勵計劃的主要目的為優化本集團的激勵機制，進一步提高相關參與者（「合資格參與
者」）的工作熱情和創造力，推動本集團的業績持續增長及在提升本集團價值的同時為合資格參與者帶來經濟
利益，以便實現合資格參與者與本集團的共同發展。
合資格參與者
合資格參與者包括董事、監事、高級管理層、本公司主要部門的主管及本集團其他成員公司的主管、骨幹及
董事會認可對本公司作出貢獻的其他僱員。

邁威（上海）生物科技股份有限公司

2026年中報

48
企業管治及其他資料

管理
董事會經股東會授權擔任首次公開發售前股權激勵計劃的計劃管理人，負責（其中包括）：
•

設定及調整獎勵的授出條件；

•

釐定承授人的身份及將授予獎勵的相應數量；

•

解釋及修訂首次公開發售前股權激勵計劃；及

•

根據首次公開發售前股權激勵計劃董事會應負責的其他事項。

真珠投資及中駿建隆的唯一普通合夥人為唐春山先生。員工激勵平台於本公司所持與獎勵相關的股份附帶的
表決權歸屬於員工激勵平台的唯一普通合夥人。員工激勵平台的普通合夥人應負責：
•

安排授予協議、員工激勵平台的合夥協議及其他相關文件的簽訂；

•

備置承授人名單，以供內部存檔；

•

根據法律法規及首次公開發售前股權激勵計劃釐定承授人所持員工激勵平台合夥權益的受讓人、轉讓
或退出方式及價格；及

•

員工激勵平台的管理、控制、運營及決策。

首次公開發售前股權激勵計劃的獎勵形式
承授人根據經股東大會批准的首次公開發售前股權激勵計劃項下授出的獎勵數量作為合夥人認購員工激勵平
台的合夥權益，並按照董事會的安排作出相應出資，因而於股份中持有間接權益。
獎勵相關股份總數
我們的員工激勵平台中駿建隆及真珠投資合共持有26,800,000股股份。承授人（不包括就此而言以各員工激勵
平台的普通合夥人身份行事的唐春山先生）通過持有員工激勵平台的合夥權益，間接於合共25,891,100股股份
（佔截至最後實際可行日期本公司股本約5.80%）中擁有權益。
於A股上市前，合共25,891,100股股份對應的所有獎勵已根據首次公開發售前股權激勵計劃授出及歸屬，且於
上市後不會據此進一步授予獎勵。由於上市後不會進一步授予獎勵，且26,800,000股股份已於A股上市前發行
予員工激勵平台，因此首次公開發售前股權激勵計劃不會導致上市後股東的股權遭遇任何攤薄。

2026年中報

邁威（上海）生物科技股份有限公司

49
企業管治及其他資料

期限
首次公開發售前股權激勵計劃自股東大會批准之日起生效。董事會獲授權審議及批准首次公開發售前股權激
勵計劃的實施、修訂及終止。
授予獎勵
董事會應釐定承授人及獎勵的分配。本公司及承授人將簽訂授予協議，員工激勵平台的普通合夥人或指定有
限合夥人與承授人簽訂股份轉讓協議。員工激勵平台的普通合夥人負責辦理有關工商變更登記手續。承授人
須以現金認購員工激勵平台的合夥權益，且應保證其資金來源真實合法。所有出資款項應全額及時支付。
轉讓限制
除首次公開發售前股權激勵計劃另有規定外，在公司上市前，承授人不得直接或間接處置於員工激勵平台持
有的合夥權益，包括但不限於向任何第三方轉讓有關合夥權益，將有關合夥權益用作抵押品，將有關合夥權
益用於償債，或對合夥權益設立任何其他權利。
此外，除首次公開發售前股權激勵計劃另行規定外及經員工激勵平台的普通合夥人同意，承授人於獎勵獲解
除限制前不得減持或轉讓於員工激勵平台持有的任何合夥權益，或直接或間接處置於員工激勵平台持有的任
何合夥權益。承授人有權根據員工激勵平台的規定獲得與其員工激勵平台的合夥權益相對應的本公司的股息
分派。董事會與本公司僱員磋商後，確定各承授人的績效目標（「績效目標」）。根據首次公開發售前股權激勵
計劃授出的獎勵於本公司評估各承授人上一財政年度績效目標的達成情況後按以下方式解除限制：
•

2022年3月31日授予承授人的獎勵總數的20%；

•

2023年3月31日授予承授人的獎勵總數的20%；及

•

2024年3月31日授予承授人的獎勵總數的60%。

獎勵已經解除限制，承授人可轉讓或處置其於員工激勵平台的合夥權益。然而，承授人僅可將其合夥權益轉
讓予員工激勵平台的普通合夥人。此外，除非承授人取得員工激勵平台普通合夥人的同意或倘本公司或承授
人的地位發生變動，否則承授人僅可按與員工激勵平台的普通合夥人磋商及約定的對價轉讓其已獲解除限制
的合夥權益。

邁威（上海）生物科技股份有限公司

2026年中報

50
企業管治及其他資料

回補機制
倘績效目標未於任何評估期內達成或倘承授人在其所有獎勵解除限制前離職，則其於員工激勵平台持有的與
未解除限制的獎勵相關的合夥權益將由員工激勵平台的普通合夥人按承授人支付的有關合夥權益的認購價購
回。
承授人的詳情
於A股上市前，合共25,891,100股股份（不包括唐春山先生作為中駿建隆及真珠投資的唯一普通合夥人所持合
夥權益對應的合共908,900股股份）佔我們已發行股份總數的約5.80%，對應的獎勵已根據首次公開發售前股
權激勵計劃授予合共94名合資格參與者。員工激勵平台的合夥權益結構詳情並無變動。詳情請參閱招股章程
「附錄四 － 法定及一般資料 － 首次公開發售前股權激勵計劃 － 承授人的詳情」一段。

XVI. 獲准許的彌償條文以及董事及高級職員責任險
有關董事及高級職員責任險的獲准許彌償保障條文（定義見公司條例（香港法例第622章））現正生效，並於截
至2026年6月30日止六個月內一直生效。本公司已於截至2026年6月30日止六個月內為本集團董事安排適當
的董事責任險保障。

XVII. 公眾持股量的充足性
根據本公司可公開獲得的資料及據董事所知，截至2026年6月30日止六個月內及直至本報告日期，本公司一
直維持上市規則第8.08條及第19A.28B(2)條所規定的公眾持股量。

2026年中報

邁威（上海）生物科技股份有限公司

51

獨立審閱報告

Ernst & Young
27/F, One Taikoo Place
979 King’s Road
Quarry Bay, Hong Kong

⭰㰟㛪姯⸒Ṳ⋀㈧
榀㸖毩歁㵳勘䙮怺 979噆
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Tel 曢婘: +852 2846 9888
Fax ₚ䜆: +852 2868 4432
ey.com

獨立審閱報告
致邁威（上海）生物科技股份有限公司股東
（於中華人民共和國成立的有限公司）

緒言
我們已審閱列載於第52至71頁的中期財務資料，該等資料包括邁威（上海）生物科技股份有限公司（「貴公司」）及其
附屬公司（「貴集團」）於2026年6月30日的簡明綜合財務狀況表與截至該日止六個月期間的相關簡明綜合損益及其他
全面收益表、權益變動表及現金流量表，以及解釋附註。香港聯合交易所有限公司證券上市規則規定，就中期財務
資料擬備的報告必須符合以上規則的有關條文以及香港會計師公會（「香港會計師公會」）頒佈的香港會計準則第34號
「中期財務報告」
（「香港會計準則第34號」）。 貴公司董事須負責根據香港會計準則第34號擬備及列報該等中期財務
資料。我們的責任為根據我們的審閱對該等中期財務資料作出結論。我們僅按照我們協定的業務約定條款向 閣下
（作為整體）報告我們的結論，除此之外本報告別無其他目的。我們不會就本報告的內容向任何其他人士負上或承擔
任何責任。

審閱範圍
我們已根據香港會計師公會頒佈的香港審閱準則第2410號「由實體的獨立核數師執行中期財務資料審閱」進行審閱。
審閱中期財務資料包括主要向負責財務和會計事務的人員作出查詢，及應用分析性及其他審閱程序。審閱的範圍遠
較根據香港審計準則進行審計的範圍為小，故不能令我們可保證我們將知悉在審計中可能被發現的所有重大事項。
因此，我們不會發表審計意見。

結論
按照我們的審閱，我們並無發現任何事項，令我們相信中期財務資料未有在各重大方面根據香港會計準則第34號編
製。

安永會計師事務所
執業會計師
香港
2026年8月30日

邁威（上海）生物科技股份有限公司

2026年中報

52

中期簡明綜合損益及其他全面收益表
截至2026年6月30日止六個月

2026年
（未經審核）
人民幣千元

2025年
（未經審核）
人民幣千元

312,453
(76,575)

101,098
(22,122)

235,878
11,052
(139,350)
(431,426)
(108,287)
(22,061)
(3,743)
(59,774)
(6,104)

78,976
31,458
(102,207)
(392,091)
(119,033)
(9,978)
3,159
(39,312)
(3,150)

(523,815)
(389)

(552,178)
(54)

(524,204)

(552,232)

(521,707)
(2,497)

(551,321)
(911)

(524,204)

(552,232)

其他全面虧損
換算集團實體海外業務的匯兌差額

(1,934)

(42)

期內其他全面虧損

(1,934)

(42)

期內全面虧損總額

(526,138)

(552,274)

歸屬於：
母公司擁有人
非控股權益

(523,641)
(2,497)

(551,363)
(911)

(526,138)

(552,274)

(1.26)

(1.38)

附註

收入
銷售成本

4

毛利
其他收入及收益
銷售及分銷開支
研發成本
行政開支
其他開支
金融資產（減值）╱ 減值撥回淨額
財務成本
應佔聯營公司虧損
除稅前虧損
所得稅開支

5
6

期內虧損
歸屬於：
母公司擁有人
非控股權益

母公司普通股權益持有人應佔每股虧損
基本及攤薄（人民幣元）
－ 期內虧損

8

2026年中報

邁威（上海）生物科技股份有限公司

53

中期簡明綜合財務狀況表
2026年6月30日

2026年
6月30日
（未經審核）
人民幣千元

2025年
12月31日
（經審核）
人民幣千元

非流動資產
物業、廠房及設備
使用權資產
商譽
其他無形資產
對聯營公司的投資
預付款項、其他應收款項及其他資產
按公允價值計入損益的金融資產

1,785,272
217,202
118,770
13,155
87,838
192,372
4,141

1,847,343
259,599
118,770
15,700
91,137
180,653
4,037

非流動資產總值

2,418,750

2,517,239

197,700
128,711
257,772
63,332
2,460
2,226,259

187,897
99,789
222,627
–
1,718
1,526,571

2,876,234

2,038,602

111,831
656,994
247
2,682
1,492,255
29,022
10,288

197,097
680,807
12,935
2,682
1,327,598
34,616
2,869

2,303,319

2,258,604

572,915

(220,002)

2,991,665

2,297,237

附註

流動資產
存貨
貿易應收款項
預付款項、其他應收款項及其他資產
按公允價值計入損益計量的金融資產
受限制現金
現金及銀行結餘

9

流動資產總值
流動負債
貿易應付款項
其他應付款項及應計費用
應付關聯方款項
衍生金融負債
計息銀行借款
租賃負債
公司債券

10

流動負債總額
流動資產淨值 ╱（負債淨額）
總資產減流動負債

邁威（上海）生物科技股份有限公司

2026年中報

54
中期簡明綜合財務狀況表
2026年6月30日

2026年
6月30日
（未經審核）
人民幣千元

2025年
12月31日
（經審核）
人民幣千元

非流動負債
其他應付款項及應計費用
計息銀行借款
租賃負債
子公司非控股股份贖回負債
公司債券

91,582
1,075,773
77,150
214,300
478,377

102,127
948,030
114,038
207,085
392,955

非流動負債總額

1,937,182

1,764,235

資產淨值

1,054,483

533,002

446,730
(49,995)
476,750

399,600
(49,995)
(98)

873,485

349,507

180,998

183,495

1,054,483

533,002

附註

權益
母公司擁有人應佔權益
股本
庫存股
儲備

11

非控股權益
總權益

2026年中報

邁威（上海）生物科技股份有限公司

55

中期簡明綜合權益變動表
截至2026年6月30日止六個月

母公司擁有人應佔

於2025年12月31日（經審核）
期內虧損

股本
人民幣千元

庫存股
人民幣千元

資本儲備
人民幣千元

受限制
股份及
購股權儲備
人民幣千元

399,600
–

(49,995)
–

5,738,533
–

21,517
–

4,454
–

(5,764,602)
(521,707)

349,507
(521,707)

183,495
(2,497)

533,002
(524,204)

–
–

–
–

–
–

–
–

(1,934)
(1,934)

–
(521,707)

(1,934)
(523,641)

–
(2,497)

(1,934)
(526,138)

47,130

–

1,000,472

–

–

–

1,047,602

–

1,047,602

–

–

–

17

–

–

17

–

17

446,730

(49,995)

6,739,005

21,534

2,520

(6,286,309)

873,485

180,998

1,054,483

期內其他全面虧損（未經審核）：
換算集團實體海外
業務的匯兌差額（未經審核）
期內全面虧損總額（未經審核）
全球發售所得款項淨額
（未經審核）
確認以股份為基礎的
付款開支（未經審核）
於2026年6月30日
（未經審核）

邁威（上海）生物科技股份有限公司

2026年中報

匯兌
波動儲備
人民幣千元

累計虧損
人民幣千元

總計
人民幣千元

非控股
權益
人民幣千元

總權益
人民幣千元

56
中期簡明綜合權益變動表
截至2026年6月30日止六個月

母公司擁有人應佔

於2024年12月31日（經審核）
期內虧損（未經審核）
期內其他全面虧損（未經審核）：
換算集團實體海外業務的匯兌差額
（未經審核）
期內全面虧損總額（未經審核）
非控股股東注資（未經審核）
對非控股股東的回購義務（未經審核）
確認以股份為基礎的付款開支（未經審核）
於2025年6月30日（未經審核）

股本
人民幣千元

資本儲備
人民幣千元

受限制
股份及
購股權儲備
人民幣千元

399,600
–

5,938,058
–

21,407
–

5,081
–

(4,795,268)
(551,321)

1,568,878
(551,321)

(13,099)
(911)

1,555,779
(552,232)

–
–
–
–
–

–
–
482
(200,000)
–

–
–
–
–
73

(42)
(42)
–
–
–

–
(551,321)
–
–
–

(42)
(551,363)
482
(200,000)
73

–
(911)
199,518
–
–

(42)
(552,274)
200,000
(200,000)
73

399,600

5,738,540

21,480

5,039

(5,346,589)

818,070

185,508

1,003,578

匯兌
波動儲備
人民幣千元

累計虧損
人民幣千元

總計
人民幣千元

非控股
權益
人民幣千元

總權益
人民幣千元

2026年中報

邁威（上海）生物科技股份有限公司

57

中期簡明綜合現金流量表
截至2026年6月30日止六個月

2026年
（未經審核）
人民幣千元

2025年
（未經審核）
人民幣千元

(523,815)

(552,178)

59,774
6,104
(5,503)
19
(300)

39,312
3,150
(3,427)
–
–

(55)
(167)
(892)
90,928
14,494
2,545
481
3,743
17
14,491

(18)
(57)
(227)
89,515
17,552
2,435
7,690
(3,159)
73
304

(338,136)
(10,287)
(29,525)
(3,011)
(743)
(85,265)
(47,266)
(189)

(399,035)
(6,848)
(18,779)
5,811
(1,869)
14,740
368,630
108

經營所用現金
已收利息
已付所得稅

(514,422)
5,438
46

(37,242)
3,481
(162)

經營活動所用現金流量淨額

(508,938)

(33,923)

附註

經營活動所得現金流量
除稅前虧損：
就以下項目作出調整：
財務成本
應佔聯營公司虧損
利息收入
出售物業、廠房及設備項目的虧損
終止租賃的收益
公允價值虧損 ╱（收益）淨額：
按公允價值計入損益計量的金融資產
按公允價值計入損益計量的金融資產的投資收益
按攤銷成本計量的金融資產的投資收益
物業、廠房及設備折舊
使用權資產折舊
其他無形資產攤銷
存貨減值虧損
貿易應收款項及其他應收款項減值虧損 ╱（減值虧損撥回）淨額
以股份為基礎的付款開支
匯兌差額淨額

存貨增加
貿易應收款項增加
預付款項、其他應收款項及其他資產（增加）╱ 減少
受限制現金增加
貿易應付款項（減少）╱ 增加
其他應付款項及應計費用（減少）╱ 增加
應付關聯方款項（減少）╱ 增加

邁威（上海）生物科技股份有限公司

2026年中報

5
5
5
5
5
5

58
中期簡明綜合現金流量表
截至2026年6月30日止六個月

2026年
（未經審核）
人民幣千元

2025年
（未經審核）
人民幣千元

投資活動所得現金流量
購買物業、廠房及設備項目
購買按公允價值計入損益計量的金融資產
贖回按公允價值計入損益計量的金融資產
購買按攤銷成本計量的金融資產
贖回按攤銷成本計量的金融資產
金融資產的投資收益
對聯營公司的投資

(61,586)
(142,094)
78,580
(45,489)
44,792
1,063
(16,000)

(87,210)
(38,106)
41,874
–
–
302
(17,086)

投資活動所用現金流量淨額

(140,734)

(100,226)

融資活動所得現金流量
新增銀行貸款
金融機構貸款
償還借款
已付利息
公司債券所得款項
上市及發行開支付款
其他融資開支
發行普通股所得款項
非控股股東注資
融資租賃保證金
租賃付款
償還金融機構貸款

1,095,302
100,000
(798,730)
(46,589)
85,000
(8,763)
(3,202)
1,095,187
–
(5,000)
(17,231)
(61,473)

867,140
100,000
(792,468)
(41,052)
–
(12,466)
–
–
200,000
–
(13,810)
(11,980)

融資活動所得現金流量淨額

1,434,501

295,364

現金及現金等價物增加淨額
期初現金及現金等價物
外匯匯率變動的影響淨額

784,829
1,526,339
(17,236)

161,215
1,227,566
(154)

期末現金及現金等價物

2,293,932

1,388,627

現金及現金等價物結餘分析
現金及銀行結餘

2,226,259

1,388,772

中期簡明綜合財務狀況表中呈列的現金及現金等價物
應收利息
現金等價物

2,226,259
(296)
67,969

1,388,772
(145)
–

中期簡明綜合現金流量表中呈列的現金及現金等價物

2,293,932

1,388,627

2026年中報

邁威（上海）生物科技股份有限公司

59

中期簡明綜合財務資料附註
2026年6月30日

1

編製基準
截至2026年6月30日止六個月的中期簡明綜合財務資料乃根據香港會計準則第34號「中期財務報告」編製。中
期簡明綜合財務資料並不包括年度財務報表中要求的所有資料及披露，且應與本集團截至2025年12月31日止
年度的年度綜合財務報表一併閱讀。

2.

會計政策變動
編製中期簡明綜合財務資料時所採納的會計政策與編製本集團截至2025年12月31日止年度的年度綜合財務報
表時所應用的會計政策一致，惟就本期間財務資料首次採納以下經修訂香港財務報告準則會計準則除外。
香港財務報告準則第9號及香港財務報告準則
第7號的修訂
香港財務報告準則第9號及香港財務報告準則
第7號的修訂
香港財務報告準則會計準則的年度改進 － 第11卷

對金融工具分類和計量的修訂
涉及依賴自然能源生產電力的合約
香港財務報告準則第1號、香港財務報告準則第7號、
香港財務報告準則第9號、香港財務報告準則
第10號及香港會計準則第7號的修訂

經修訂的香港財務報告準則會計準則的性質及影響描述如下：
(a)

香港財務報告準則第9 號及香港財務報告準則第7號的修訂「對金融工具分類和計量的修訂」闡明於實
體的合約現金流權利屆滿或轉移時終止確認金融資產，而於結算日終止確認金融負債。該等修訂引入
一項會計政策選擇，在符合特定條件的情況下，終止確認於結算日前透過電子付款系統結算的金融負
債。該等修訂澄清如何評估具有環境、社會及管治以及其他類似或然特徵的金融資產的合約現金流量
特徵。此外，該等修訂澄清具有無追索權特徵的金融資產及合約掛鈎工具的分類規定。該等修訂亦包
括指定以公允價值計量且其變動計入其他全面收益的權益工具投資及具有或然特徵的金融工具的額外
披露。由於本集團過往年度就終止確認金融資產及負債的會計政策與該等修訂一致，且本集團並無該
等修訂所涵蓋的金融資產，故該等修訂並未對中期簡明綜合財務資料造成任何影響。本集團將於其截
至2026年12月31日止年度的綜合財務報表中，就其指定為按公允價值計入其他全面收益的股權投資提
供額外披露。

邁威（上海）生物科技股份有限公司

2026年中報

60
中期簡明綜合財務資料附註
2026年6月30日

2.

3.

會計政策變動（續）
(b)

香港財務報告準則第9號及香港財務報告準則第7號的修訂「涉及依賴自然電力的合約 」闡明適用範圍內
合約「自用」要求的適用情況，並修訂適用範圍內合約於現金流量對沖關係中被對沖項目的指定要求。
該等修訂亦包括額外披露，使財務報表使用者能夠了解該等合約對實體財務表現及未來現金流量的影
響。由於本集團並無任何屬於該等修訂範圍內的合約，故該等修訂並未對中期簡明綜合財務資料造成
任何影響。

(c)

香港財務報告準則會計準則的年度改進 － 第11卷載列香港財務報告準則第1號、香港財務報告準則第
7號（及隨附的香港財務報告準則第7號實施指引）、香港財務報告準則第9號、香港財務報告準則第10
號及香港會計準則第7號的小範圍修訂。該等修訂包括對相應香港財務報告準則會計準則的釐清、簡
化、更正或旨在提高一致性的變動。該等修訂並未對中期簡明綜合財務資料造成任何影響。

經營分部資料
就管理目的而言，本集團並未按其服務劃分業務單位，且僅有一個可呈報經營分部。管理層監察本集團的整
體經營分部的經營業績，以作出有關資源分配及表現評估的決策。由於本集團僅有一個可報告經營分部，故
並無呈列進一步經營分部分析。

4.

收入
收入分析如下：
截至6月30日止六個月
2026年
人民幣千元
（未經審核）

2025年
人民幣千元
（未經審核）

312,453

101,098

客戶合約收入

2026年中報

邁威（上海）生物科技股份有限公司

61
中期簡明綜合財務資料附註
2026年6月30日

4.

收入（續）
客戶合約收入的分拆收入資料
截至6月30日止六個月
2026年
人民幣千元
（未經審核）

2025年
人民幣千元
（未經審核）

商品或服務類型
產品銷售
對外授權及提供服務

212,597
99,856

101,004
94

總計

312,453

101,098

收入確認時間
於某一時點轉讓

312,453

101,098

邁威（上海）生物科技股份有限公司

2026年中報

62
中期簡明綜合財務資料附註
2026年6月30日

5.

除稅前虧損
本集團除稅前虧損乃經扣除 ╱（計入）以下各項後得出：
截至6月30日止六個月
2026年
人民幣千元
（未經審核）

2025年
人民幣千元
（未經審核）

已售存貨成本
提供服務成本
物業、廠房及設備折舊
使用權資產折舊
其他無形資產攤銷
研發成本
政府補助
僱員福利開支（包括董事及最高行政人員的薪酬）：
工資及薪金
以權益結算以股份為基礎的付款
退休金計劃供款

70,530
6,045
90,928
14,494
2,545
431,426
(3,943)

22,034
88
89,515
17,552
2,435
392,091
(25,471)

194,526
17
42,257

175,747
73
40,417

總計

236,800

216,237

3,743
481

(3,159)
7,690

貿易應收款項及其他應收款項減值虧損 ╱（減值虧損撥回）淨額
存貨減值虧損

已售存貨成本及研發成本包括與物業、廠房及設備折舊、使用權資產折舊、其他無形資產攤銷及僱員福利開
支有關的費用，該等費用亦計入上文獨立披露的各類費用相應總額中。

2026年中報

邁威（上海）生物科技股份有限公司

63
中期簡明綜合財務資料附註
2026年6月30日

6.

所得稅
我們須就本集團成員公司註冊所在及經營所在司法權區產生或所得的利潤按實體基準繳納所得稅。
本集團於報告期內的所得稅開支分析如下：
截至6月30日止六個月
2026年
人民幣千元
（未經審核）

2025年
人民幣千元
（未經審核）

即期稅項：
期內支出

389

54

期內稅項支出總額

389

54

邁威（上海）生物科技股份有限公司

2026年中報

64
中期簡明綜合財務資料附註
2026年6月30日

7.

股息
本公司並無於報告期內派付或宣派股息（2025年：無）。

8.

母公司普通股權益持有人應佔每股虧損
每股基本虧損金額乃根據母公司普通股權益持有人應佔期內虧損，以及期內已發行普通股加權平均數
415,072,000股（2025年：399,600,000股）計算。
計算所用的普通股加權平均數為計算每股基本盈利所用的期內已發行普通股數目。
本集團於截至2026年及2025年6月30日止期間並無具潛在攤薄效應的已發行普通股。
每股基本及攤薄虧損的計算乃根據：
截至6月30日止六個月
2026年
人民幣千元
（未經審核）

2025年
人民幣千元
（未經審核）

虧損
計算每股基本及攤薄虧損所用的母公司普通股權益持有人應佔虧損
（人民幣千元）

(521,707)

(551,321)

股份（千股）
計算每股基本虧損所用的期內發行在外普通股加權平均數

415,072

399,600

2026年中報

邁威（上海）生物科技股份有限公司

65
中期簡明綜合財務資料附註
2026年6月30日

9.

貿易應收款項
於報告期末，基於發票日期及扣除虧損撥備的貿易應收款項的賬齡分析如下：

一年內

2026年
6月30日
人民幣千元
（未經審核）

2025年
12月31日
人民幣千元
（經審核）

128,711

99,789

2026年
6月30日
人民幣千元
（未經審核）

2025年
12月31日
人民幣千元
（經審核）

111,831

197,097

10. 貿易應付款項
於報告期末按發票日期列示的貿易應付款項賬齡分析如下：

一年內
貿易應付款項為不計息，且通常於30至180日的期限結清。

11. 股本
期內，本公司因其於香港聯合交易所有限公司上市而發行47,130,200股每股面值人民幣1.00元的普通股。因
此，已發行普通股總數由2025年12月31日的399,600,000股增加至2026年6月30日的446,730,200股。

12. 承擔
2026年
6月30日
人民幣千元
（未經審核）

2025年
12月31日
人民幣千元
（經審核）

已訂約但未撥備：
物業、廠房及設備
對聯營公司的投資

101,205
4,000

182,914
7,500

總計

105,205

190,414

邁威（上海）生物科技股份有限公司

2026年中報

66
中期簡明綜合財務資料附註
2026年6月30日

13. 關聯方交易
(a)

於期內，本集團與關聯方有以下交易：
截至6月30日止六個月

附註

服務採購
智享生物
施朗

2026年
人民幣千元
（未經審核）

2025年
人民幣千元
（未經審核）

182
522

–
569

704

569

–

121

–

121

6,756
–

6,804
202

6,756

7,006

(i)

總計
設備採購
青玄

(ii)

總計
租賃付款
施朗
歌斐木

(iii)

總計
附註：
(i)

服務採購包括就電力服務及技術服務收取的服務，該等服務經參考市價後，根據關聯方提供的價格及條款採購。

(ii)

設備採購經參考市價後，根據關聯方提供的價格及條款採購，用於研發活動。

(iii)

租賃包括租賃的樓宇，該等樓宇經參考市價後，根據關聯方提供的價格及條款租賃，用作辦公室及實驗室。

2026年中報

邁威（上海）生物科技股份有限公司

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中期簡明綜合財務資料附註
2026年6月30日

13. 關聯方交易（續）
(b)

與關聯方的未償還餘額：
2026年
6月30日
人民幣千元
（未經審核）

2025年
12月31日
人民幣千元
（經審核）

租賃負債 － 即期
施朗

12,097

11,637

租賃負債 － 非即期
施朗

40,138

46,993

應付關聯方款項 － 即期（交易性質）
思努賽
施朗
青潤

–
247
–

12,500
152
283

總計

247

12,935

與關聯方的所有交易性質未償還餘額均為無抵押及不計息。

(c)

本集團主要管理人員的薪酬
截至6月30日止六個月
2026年
人民幣千元
（未經審核）

2025年
人民幣千元
（未經審核）

薪金、花紅及津貼
退休金計劃供款及社會福利

19,507
1,048

11,612
1,010

向主要管理人員支付的薪酬總額

20,555

12,622

邁威（上海）生物科技股份有限公司

2026年中報

68
中期簡明綜合財務資料附註
2026年6月30日

14. 金融工具的公允價值及公允價值層級
管理層經評估後認為，現金及銀行結餘、受限制現金、貿易應收款項、計入預付款項、其他應收款項及其他
資產的金融資產（流動部分）、貿易應付款項、計入其他應付款項及應計費用的金融負債、計息銀行借款以及
應付關聯方款項的公允價值與其賬面值相若，主要是由於該等工具均屬短期性質。
本集團以財務經理為首的財政部門負責釐定金融工具之公允價值計量的政策及程序。於各報告日期末，財務
部門分析金融工具價值的變動並釐定估值所用的主要輸入數據。董事定期就財務報告審閱金融工具公允價值
計量的結果。
金融資產及負債的公允價值按自願雙方（強迫或清盤出售除外）在當前交易下的可交換該工具的金額入賬。下
列方法及假設用於估計公允價值：
計入預付款項、其他應收款項及其他資產的金融資產非流動部分的公允價值乃按使用有類似條款、信貸風險
及餘下到期日的工具目前可得的利率折現預期未來現金流量計算。

2026年中報

邁威（上海）生物科技股份有限公司

69
中期簡明綜合財務資料附註
2026年6月30日

14. 金融工具的公允價值及公允價值層級（續）
於2026年6月30日及2025年12月31日金融工具估值所用重大不可觀察輸入數據連同量化敏感度分析概述如
下：

於2026年6月30日及2025年12月31日
金融負債 ╱ 資產

公允價值層級

估值方法

不可觀察
輸入數據

不可觀察輸入數據
對公允價值的敏感度

第三級

二項式模型

無風險利率

上升 ╱ 下降1%將導致
公允價值減少 ╱ 增加0.1%
上升 ╱ 下降1%將導致
公允價值增加 ╱ 減少0.8%
上升 ╱ 下降1%將導致
公允價值增加 ╱ 減少1%
上升 ╱ 下降1%將導致
公允價值減少 ╱ 增加0.1%
上升 ╱ 下降1%將導致
公允價值增加 ╱ 減少0.1%
上升 ╱ 下降1%將導致
公允價值增加 ╱ 減少9%

衍生金融負債

波幅
行使概率
按公允價值計入損益
計量的金融資產

第三級

市場法及
收益法

無風險利率
波幅
行使概率

邁威（上海）生物科技股份有限公司

2026年中報

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中期簡明綜合財務資料附註
2026年6月30日

14. 金融工具的公允價值及公允價值層級（續）
公允價值層級
下表說明本集團金融工具的公允價值計量層級：
按公允價值計量的資產：
計量公允價值時使用

於2026年6月30日
按公允價值計入損益計量的金融資產

於活躍
市場之報價
（第一級）
人民幣千元

重大可觀察
輸入數據
（第二級）
人民幣千元

重大不可觀察
輸入數據
（第三級）
人民幣千元

總計
人民幣千元

–

63,332

4,141

67,473

計量公允價值時使用

於2025年12月31日
按公允價值計入損益計量的金融資產

於活躍
市場之報價
（第一級）
人民幣千元

重大可觀察
輸入數據
（第二級）
人民幣千元

重大不可觀察
輸入數據
（第三級）
人民幣千元

總計
人民幣千元

–

–

4,037

4,037

2026年中報

邁威（上海）生物科技股份有限公司

71
中期簡明綜合財務資料附註
2026年6月30日

14. 金融工具的公允價值及公允價值層級（續）
公允價值層級（續）
按公允價值計量的負債：
計量公允價值時使用

於2026年6月30日
衍生金融負債

於活躍
市場之報價
（第一級）
人民幣千元

重大可觀察
輸入數據
（第二級）
人民幣千元

重大不可觀察
輸入數據
（第三級）
人民幣千元

總計
人民幣千元

–

–

2,682

2,682

計量公允價值時使用

於2025年12月31日
衍生金融負債

於活躍
市場之報價
（第一級）
人民幣千元

重大可觀察
輸入數據
（第二級）
人民幣千元

重大不可觀察
輸入數據
（第三級）
人民幣千元

總計
人民幣千元

–

–

2,682

2,682

15. 報告期後事項
本集團於2026年6月30日後並無進行任何重大期後事項。

邁威（上海）生物科技股份有限公司

2026年中報

72

前瞻性陳述

本報告中所有不屬於歷史事實或與當前事實或當前條件無關的陳述都是前瞻性陳述。此類前瞻性陳述表達了本集團
截至最後實際可行日期對未來事件的當前觀點、預測、信念及預期。此類前瞻性陳述是基於本集團無法控制的一些
假設及因素。因此，其受到重大風險及不確定性的影響，實際事件或結果可能與該等前瞻性陳述有重大差異，本報
告中討論的前瞻性事件可能不會發生。該等風險及不確定性包括但不限於本中期報告「主要風險及不確定性」一節以
及在我們公司網站 http://www.mabwell.com 上發佈的招股章程中「風險因素」一節的有關詳情。對於本報告中的任
何預測、目標、估計或期望的實現或合理性，我們不作任何聲明或保證，亦不應加以依賴。

2026年中報

邁威（上海）生物科技股份有限公司

73

釋義

「A股」

指

本公司發行的每股面值人民幣1.00元的普通股，以人民幣認購或入賬列作
繳足，並於上海證券交易所科創板上市買賣

「A股股東」

指

A股持有人

「A股發行」

指

本公司於2022年1月18日在上海證券交易所科創板上市交易的99,900,000
股A股首次公開發售

「A股招股說明書」

指

於2022年1月10日就A股發行而刊發的招股說明書

「聯屬人士」

指

就任何特定人士而言，直接或間接控制該特定人士或受該特定人士直接或
間接控制或與該特定人士直接或間接受共同控制的任何其他人士

「組織章程細則」或「細則」

指

本公司自上市日期起生效的組織章程細則（經修訂）

「聯繫人」

指

具有上市規則賦予該詞的涵義

「審計委員會」

指

本公司審計委員會

「董事會」

指

董事會

「藥品審評中心」

指

國家藥監局藥品審評中心

「中國」

指

除非文義另有所指及僅就本報告而言，應與中國內地具有相同涵義

「中國內地」或「內地」

指

中華人民共和國內地，不包括中華人民共和國香港、澳門及台灣地區

「本公司」

指

邁威（上海）生物科技股份有限公司，一家於2017 年5 月12 日在中國註冊
成立的有限責任公司，並於2020年6月30日根據中國公司法由其前身邁威
（上海）生物科技有限公司改制為股份有限公司，其A股在上海證券交易所
科創板上市（證券代碼：688062）

「控股股東」

指

具有上市規則賦予該詞的涵義，除文義另有所指外，指唐春山先生、陳姍
娜女士、朗潤股權、中駿建隆、真珠投資及朗潤投資諮詢

邁威（上海）生物科技股份有限公司

2026年中報

74
釋義

「核心產品」

指

具有上市規則第18A章賦予該詞的涵義且為符合上市規則第18A章資格要
求的產品，此處所述是指9MW2821

「企業管治守則」

指

上市規則附錄C1所載企業管治守則

「董事」

指

本公司董事

「合資格參與者」

指

具有本報告「十五.股份激勵計劃 － 首次公開發售前股權激勵計劃 － 目的」
一段賦予該詞的涵義

「員工激勵平台」

指

真珠投資及中駿建隆

「ESG委員會」

指

董事會環境、社會及管治(ESG)委員會

「FDA」

指

美國食品藥品監督管理局

「全球發售」

指

按招股章程所述條款並在其條件的規限下進行的股份首次公開發售

「本集團」或「我們」

指

本公司及其子公司

「H股」

指

本公司股本中每股面值人民幣1.00 元的上市普通股，將以港元認購及買
賣，並於香港聯交所上市

「港元」

指

港元，香港法定貨幣

「香港」

指

中華人民共和國香港特別行政區

「香港聯交所」或「聯交所」

指

香港聯合交易所有限公司，香港交易及結算所有限公司的全資子公司

「首次公開發售」

指

首次公開發售

「朗潤股權」

指

朗潤（深圳）股權投資基金企業（有限合夥），一家於2015 年12 月2 日在中
國成立的有限合夥企業（朗潤投資諮詢為其唯一普通合夥人）及一名控股
股東

2026年中報

邁威（上海）生物科技股份有限公司

75
釋義

「朗潤投資諮詢」

指

深圳市朗潤投資諮詢管理有限公司，一家於2015 年11月17日在中國成立
的有限公司及一名控股股東

「朗潤邁威」

指

上海朗潤邁威生物醫藥科技有限公司，一家於2017年5月31日在中國註冊
成立的有限公司及本公司的直接全資子公司

「最後實際可行日期」

指

2026年8月30日，即本報告付印前確定本報告當中所載若干資料的最後實
際可行日期

「上市」

指

H股於主板上市

「上市日期」

指

2026年4月28日

「上市規則」

指

《香港聯合交易所有限公司證券上市規則》
（經不時修訂、補充或以其他方
式修改）

「主板」

指

香港聯交所運作的證券交易所（不包括期權市場），獨立於香港聯交所GEM
且與其並行運作

「標準守則」

指

上市規則附錄C3所載上市發行人董事進行證券交易的標準守則

「NMPA」

指

國家藥品監督管理局，或（視文義所指）其前身國家食品藥品監督管理總
局（或國家食藥監總局）

「全國人大」

指

中華人民共和國全國人民代表大會

「提名委員會」

指

本公司提名委員會

「首次公開發售前股權
激勵計劃」

指

本公司於2020年6月19日批准及採納的首次公開發售前股權激勵計劃（於
2024年12月31日經本公司股東決議案修訂）
（經不時修訂），其主要條款概
要載於本報告「十五.股份激勵計劃 － 首次公開發售前股權激勵計劃」一段

邁威（上海）生物科技股份有限公司

2026年中報

76
釋義

「招股章程」

指

本公司於2026年4月20日就全球發售刊發的招股章程

「薪酬與考核委員會」

指

本公司薪酬與考核委員會

「報告期間」

指

2026年1月1日至2026年6月30日期間

「人民幣」

指

人民幣，中國的法定貨幣

「證監會」

指

香港證券及期貨事務監察委員會

「證券及期貨條例」

指

香港法例第571 章《證券及期貨條例》
（經不時修訂、補充或以其他方式修
改）

「上海證券交易所」

指

上海證券交易所

「上海證券交易所科創板」

指

上海證券交易所科創板

「股份」

指

本公司股本中每股面值人民幣1.00元的普通股

「股東」

指

本公司股份持有人

「戰略委員會」

指

本公司戰略委員會

「聯交所」

指

香港聯合交易所有限公司

「子公司」

指

具有公司條例第15條賦予該詞的涵義

「美國」

指

美利堅合眾國，其領土及屬地及受其司法管轄的所有地區

「美元」

指

美元，美國的法定貨幣

「真珠投資」

指

寧波梅山保稅港區真珠投資管理合夥企業（有限合夥），一家於2018年1月
16日在中國成立的有限合夥企業（唐先生為其唯一普通合夥人），同時亦為
控股股東及員工激勵平台之一

「中駿建隆」

指

寧波梅山保稅港區中駿建隆投資合夥企業（有限合夥），一家於2017 年11
月2日在中國成立的有限合夥企業（唐先生為其唯一普通合夥人），同時亦
為控股股東及員工激勵平台之一

「%」

指

百分比

2026年中報

邁威（上海）生物科技股份有限公司

77

詞彙表

「ADC」

指

抗體偶聯藥物，一類由靶向腫瘤特異性抗原的單克隆抗體與強效抗腫瘤小
分子藥物通過化學連接子偶聯而成的藥物

「AMD」

指

年齡相關性黃斑變性，一種影響視力中心區域的疾病

「AML」

指

急性髓系白血病

「抗體」

指

亦稱為免疫球蛋白，免疫系統用來識別並結合抗原的蛋白

「APS」

指

培養基模擬灌裝

「ASCO」

指

美國臨床腫瘤學會

「BCVA」

指

最佳矯正視力

「BFv」

指

bulumtatug fuvedotin

「BTD」

指

突破性療法認定，旨在加快開發和審查擬用於治療嚴重疾病的藥物的過程

「CC」

指

宮頸癌，一種發生在子宮頸細胞的癌症

「CD」

指

分化簇

「CDH17」

指

鈣黏蛋白17

「化療」

指

一類癌症治療方法，使用一種或多種抗癌化療藥物作為標準化療方案的一
部分

「臨床試驗 ╱ 研究」

指

以人體為對象的試驗，意在驗證或發現試驗藥物的療效及不良反應，以確
定其治療價值與安全性

「CMC」

指

化學、生產及控制

「CMML」

指

慢性粒單核細胞白血病

「CMO」

指

合同生產組織，按合同為製藥行業的其他公司提供從藥物開發至藥物生產
等綜合服務的公司

「COPD」

指

慢性阻塞性肺疾病

邁威（上海）生物科技股份有限公司

2026年中報

78
詞彙表

「CRT」

指

中央視網膜厚度

「DAR」

指

藥物抗體比率，與抗體偶聯的藥物數量

「DME」

指

糖尿病性黃斑水腫，糖尿病患者出現的一種眼部疾病，其特徵是視網膜內
積液聚集引起的視網膜增厚

「EC」

指

食管癌，一種在食道組織形成惡性腫瘤細胞的疾病

「ESMO」

指

歐洲腫瘤內科學會

「Fc」

指

可結晶片段

「FTD」

指

快速通道認定

「G-CSF」

指

粒細胞集落刺激因子

「GMP」

指

藥品生產質量管理規範，為遵守由控制藥品生產和銷售的授權及許可的機
構所建議的準則而必須採取的規範

「HSA」

指

人血清白蛋白

「IBD」

指

炎症性腸病

「IDDC」

指

鏈間二硫化物藥物偶聯

「IL-33」

指

白細胞介素-33

「適應症」

指

使用特定測試、藥物、設備、程序或手術的有效理由

「研究者選擇的化療」

指

臨床試驗研究者選擇的化療治療方案

「IND」

指

新藥研究申請，是監管部門在藥品審查過程中決定是否批准臨床試驗的第
一步；在中國也被稱為臨床試驗申請

「IO」

指

免疫治療

「ITIM」

指

免疫受體酪氨酸抑制基序

「轉移性」

指

對任何疾病的提述，包括癌症、致病微生物或惡性或癌變細胞通過血管或
淋巴管或體腔轉移至身體其他部位

「MM」

指

多發性骨髓瘤

「MS」

指

多發性硬化症

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詞彙表

「NDA」

指

新藥申請，監管部門要求的批准新藥上市銷售的流程

「Nectin-4」

指

Nectin細胞黏附分子4，是Nectin家族的一種I型膜蛋白，作為細胞黏附分
子發揮作用，在多種腫瘤類型中過度表達

「ODD」

指

孤兒藥資格認定

「PBC」

指

原發性膽汁性膽管炎

「PCC」

指

臨床前候選化合物

「PD」

指

藥效動力學，有關藥物作用及其作用機制的藥理學分支

「PD-1」

指

程序性細胞死亡受體-1，在T細胞、B細胞及巨噬細胞上表達的免疫檢查點
受體，關閉T細胞介導的免疫應答，作為阻止健康免疫系統攻擊體內其他
致病性細胞的程序的一部分

「I期臨床試驗」

指

對健康人體試驗對象或患有目標疾病或病症的患者給藥，研究藥物安全
性、劑量耐受性、吸收、代謝、分佈、排出，並在可能情況了解其早期藥
效的研究

「Ia期臨床試驗」

指

在健康人體試驗對象或患者身上進行單次劑量遞增測試，以初步評估不同
劑量水平下的安全性、劑量耐受性和PK/PD的研究

「Ib期臨床試驗」

指

於II期或III期臨床試驗開始前在健康人體試驗對象或患者身上進行多次劑
量遞增測試，以初步評估不同劑量水平下的安全性、劑量耐受性和PK/PD
的研究

「II期臨床試驗」

指

對有限的患者群體給藥，以確定可能的不良反應及安全風險，初步評價該
產品對特定目標疾病的療效，並確定劑量耐受性和最佳劑量的研究

「III期臨床試驗」

指

在良好控制的臨床試驗中對擴大的患者群體給藥，一般在地域分散的臨床
試驗機構開展，以產生充足數據在統計學上評價該產品的療效及安全性以
獲批准，並為產品標籤提供充分信息的研究

「PK」

指

藥代動力學，對藥物的身體吸收、分佈、代謝和排出的研究，其與藥效動
力學一起影響藥物的劑量、益處和副作用

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詞彙表

「鉑類化療」

指

一組含鉑化合物的藥物，是一種針對多類癌症的成熟化療治療方式，靶向
迅速分裂的癌細胞並干擾其DNA結構，促使癌細胞凋亡

「臨床前研究」

指

在非人類受試對象上測試藥物的研究，以收集療效、毒性、藥代動力學和
安全性資料，並確定藥物是否可進行臨床試驗

「QP」

指

質量授權人

「研發」

指

研究及開發

「RANKL」

指

核因子κB受體活化因子配體

「類風濕關節炎」

指

主要影響關節的炎症性自身免疫性疾病

「RVO」

指

視網膜靜脈閉塞

「T1DM」

指

1型糖尿病

「TAA」

指

腫瘤相關抗原

「TCE」

指

T細胞接合器

「TEAEs」

指

治療期間不良事件

「TMPRSS6」

指

跨膜蛋白酶絲氨酸6

「TNBC」

指

三陰性乳腺癌，一種雌激素受體、孕激素受體和過量HER2 蛋白檢測均呈
陰性的乳腺癌

「TNF-α」

指

腫瘤壞死因子-α，一種在炎症及免疫反應中起核心作用的細胞因子

「特瑞普利單抗」

指

上海君實生物醫藥科技股份有限公司開發的一款用於治療包括多種實體瘤
在內的適應症的抗PD-1抗體藥物

「UC」

指

尿路上皮癌，一種通常發生在泌尿系統的癌症

「VEGF」

指

血管內皮生長因子

「WOC」

指

世界眼科大會

本報告中英文文本如有任何不一致，概以英文文本為準。

2026年中報

邁威（上海）生物科技股份有限公司