上海宝济药业（2659.HK）发布2026年中期业绩：亏损收窄16.1%至1.54亿元，管线多里程碑推进

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contents of this announcement.

Shanghai Bao Pharmaceuticals Co., Ltd.
上海寶濟藥業股份有限公司

(A joint stock company established in the People ’s Republic of China with limited liability)

(Stock Code: 2659)

INTERIM RESULTS ANNOUNCEMENT
FOR THE SIX MONTHS ENDED JUNE 30, 2026
The board (the “Board”) of directors (the “Directors”) of Shanghai Bao Pharmaceuticals Co.,
Ltd. (上海寶濟藥業股份有限公司) (the “Company”, together with its subsidiary, the “Group”)
is pleased to announce the unaudited condensed consolidated interim results of the Group for the
six months ended June 30, 2026 (the “Reporting Period”), together with the comparative figures
for the six months ended June 30, 2025 (the “Corresponding Period”). The unaudited interim
condensed consolidated financial information of the Group for the Reporting Period has been
reviewed by the Board and the Audit Committee.
In this announcement, “we”, “us” and “our” refer to the Company and where the context otherwise
requires, the Group. Certain amounts and percentage figures included in this announcement have
been subject to rounding adjustments or have been rounded to one or two decimal places, as
appropriate. Any discrepancies in any table, chart or elsewhere between totals and sums of amounts
listed therein are due to rounding.

1

BUSINESS HIGHLIGHTS
During the Reporting Period and up to the date of this announcement, we continued rapidly
advancing the development of our drug pipeline. The following is a summary of our key
historical and current milestones and achievements:
Progress of Our Products

Progress of Core Products
•

KJ017 (Recombinant Human Hyaluronidase)


KJ017 is a highly glycosylated recombinant human hyaluronidase that can specifically
degrade hyaluronic acid in subcutaneous tissue and temporarily and locally increase
the permeability of the extracellular matrix in subcutaneous tissue, thereby enabling
safe, rapid and large-volume subcutaneous administration and providing a new option
to address drug administration challenges for patients with difficult intravenous
access. Compared with conventional animal-derived hyaluronidase, which carries
a risk of allergic reactions, requires skin testing prior to use, and is subject to
inconsistent quality between batches, KJ017 adopts recombinant gene technology
and, through a controlled manufacturing process, can achieve a high degree of
batch-to-batch consistency, improve safety, and significantly reduce immunogenicity
risk. No skin test is required before use, thereby enhancing the convenience and
safety of clinical use.



KJ017 is the most advanced recombinant human hyaluronidase in China. In March
2026, our internally developed Human Hyaluronidase for Injection (葆舒宜 ®), in the
385U/vial dosage strength, was approved for marketing by the NMPA for use as an
adjuvant to subcutaneous infusion, including Sodium Chloride Injection and Sodium
Lactate Ringer’s Injection.



During the Reporting Period, results from two randomized, double-blind,
self-controlled Phase III clinical trials of KJ017 were published in the European
Journal of Pharmaceutics and Biopharmaceutics . The results showed that KJ017
enhanced gravity-driven SC infusion performance while maintaining favorable safety
and tolerability. By increasing SC tissue permeability, KJ017 enabled the delivery
of clinically relevant fluid volumes through the SC route across multiple anatomical
sites. These findings support the further development of KJ017 as an adjunct for
large-volume SC administration and its potential co-administration with therapeutic
agents requiring rapid or high-volume SC delivery.



We will advance commercialization preparations for KJ017 in an orderly manner
and evaluate the most appropriate commercialization model, including potential
collaborations with specialized commercialization service providers or leading
biopharmaceutical companies with established promotion capabilities. We expect to
leverage the sales networks, distribution channels and commercialization expertise
of selected partners to support market access, medical affairs, channel management
and subsequent commercialization of KJ017 across different regions, with a view to
broadening its market coverage and realizing its clinical and commercial value.

2



•

As of the date of this announcement, we had established formal collaboration
partnerships with multiple pharmaceutical and biotechnology companies (including,
among others, WuXi Biologics (2269.HK), Qyuns (2509.HK), Shanghai RAAS
(002252.SZ), and Sumgen) to co-develop subcutaneous formulations. In addition
to the collaborations disclosed above, we continue to proactively expand our
collaboration ecosystem. More than 60 partners have used our recombinant human
hyaluronidase in their product development, with projects at various stages ranging
from early-stage research to clinical development. As such collaborations are
subject to confidentiality obligations, details thereof have not been disclosed in
this announcement. Under our typical collaboration model, we continuously supply
our recombinant human hyaluronidase product as an excipient and provide related
technical services, while our partners independently fund the development of
subcutaneous formulations used in combination with their product candidates.


In January 2025, we entered into a strategic cooperation agreement with WuXi
Biologics (Shanghai) Co., Ltd. (上海藥明生物技術有限公司), a wholly-owned
subsidiary of WuXi Biologics (2269.HK), in relation to the supply,
manufacturing and licensing of recombinant human hyaluronidase. Pursuant to
the agreement, the Company and WuXi Biologics intend to achieve mutually
beneficial cooperation in the application of recombinant human hyaluronidase
for subcutaneous drug delivery, and to jointly pursue in-depth development of
new business opportunities and expansion of new customer channels.



In January 2026, we and Guangxi Laishi Biopharmaceutical Co., Ltd. (廣西萊
士生物製藥有限公司), a wholly-owned subsidiary of Shanghai RAAS (002252.
SZ), jointly announced that the parties had entered into a strategic cooperation
in relation to the development of new blood product formulations based on
hyaluronidase-enabled subcutaneous administration technology. Pursuant to the
agreement, the parties will leverage the Company’s subcutaneous drug delivery
technology platform together with the leading strengths of Shanghai RAAS
in the blood products sector to jointly develop novel blood product treatment
solutions with enhanced convenience and improved patient friendliness, with the
aim of improving patient compliance and optimizing the utilization of healthcare
resources.

KJ103 (Recombinant IgG-Degrading Enzyme)


KJ103 is a globally first-in-class, low-immunogenicity innovative recombinant
immunoglobulin G ( “ IgG ” )-degrading enzyme for the treatment of various
immune-mediated diseases and conditions driven by pathogenic IgG antibodies.
KJ103 specifically cleaves IgG at a specific site in the hinge region between CH1 and
CH2 by binding to the CH2 domain in the constant region of IgG. With a well-defined
mechanism of action and a low immunogenicity risk, KJ103 can safely, efficiently,
rapidly and specifically degrade human IgG.



KJ103 is the first and only low-immunogenic IgG-degrading enzyme to reach
the registrational clinical stage globally, and has obtained Breakthrough Therapy
Designation (“BTD”) from the NMPA both as a desensitization therapy in kidney
transplantation and for the treatment of anti-GBM disease. KJ103 is designed to target
and degrade IgG antibodies in the blood and tissues, thereby inhibiting pathogenic
IgG-mediated immune responses that cause various immunological conditions.

3

•



For desensitization before kidney transplantation, we initiated the Phase III clinical
trial (CTR20252973) in August 2025, and completed the primary trial follow-up for
all enrolled subjects in March 2026. Subsequent to the submission in May 2026, the
NDA was included in the priority review and approval procedure by the Center for
Drug Evaluation of the NMPA in the same month, and was accepted by the NMPA in
June 2026. For the anti-GBM disease indication, we completed the Phase II clinical
trial in October 2025 and convened the Phase III clinical trial investigator meeting
in January 2026. For the GBS indication, we received IND approval from the NMPA
in April 2025, and we are actively advancing the Phase II clinical trial initiated in
November 2025.



In the Phase III clinical trial (CTR20252973) of KJ103 for desensitization treatment
in highly sensitized kidney transplant patients completed in March 2026, KJ103
met the primary endpoint and demonstrated a rapid and significant desensitization
effect. The data showed a 100% success rate in desensitization therapy prior to
transplantation and a 100% success rate in kidney transplantation, with no hyperacute
rejection observed. KJ103 also demonstrated a favorable safety profile, with no
KJ103-related serious adverse events reported.



In June 2026, results from a Company-sponsored Phase II, open-label, single-arm,
multicenter study of early repeated administration of KJ103 (Ricefidase) in patients
with anti-GBM disease were presented at the 63rd Congress of the European Renal
Association (ERA). The study indicated that KJ103 enabled highly efficient, rapid,
and sustained clearance of anti-GBM antibodies, with potential clinical benefits in
key outcomes, thereby providing a novel direction for therapeutic exploration in this
life-threatening rare autoimmune disease.



In November 2025, the Company was awarded a pivotal task under the National
Science and Technology Major Project “ Medical-Grade Donor Pig Breeding and
Clinical Translation of Xenotransplantation,” taking on a critical role in providing the
key drugs essential for overall clinical translation. During the project, leveraging our
R&D strengths in recombinant enzymes and immunomodulatory drugs, we provided
multiple critical immunotherapeutic agents that supported the long-term survival of
the xenogeneic kidney transplant. As of the date of this announcement, the recipient
monkey has survived for more than 660 days with stable renal graft function,
representing a new Asia record for the long-term survival of non-human primates
following xenogeneic kidney transplantation. This achievement demonstrates our
ability to provide key support for the exploration and innovation of immunological
intervention strategies for xenotransplantation, as well as the potential to contribute to
the future development of xenotransplantation.

SJ02 (Slonva ® (晟諾娃 ®)) (Long-acting Recombinant Human FSH-CTP)


S J02 i s a l o n g - a c t i n g r e c o m b i n a n t h u m a n f o l l i c l e - s t i m u l a t i n g h o r m o n e
carboxyl-terminal peptide fusion protein (FSH-CTP) designed for controlled ovarian
stimulation in combination with a gonadotropin-releasing hormone antagonist
approved in China. This treatment regimen effectively stimulates multiple follicular
development in females undergoing superovulation or assisted reproductive
technology (ART) procedures.

4



In China, we received the NDA approval for SJ02 under the approved drug name
Corifollitropin alfa N01 Injection (Slonva® (晟諾娃 ®)) in August 2025 and completed
the delivery of the first order in November 2025. In July 2025, we entered into
an exclusive sales agency agreement with an independent third party, Anhui
Anke Biotechnology (Group) Co., Ltd. ( “ ANKE BIO, ” 300009.SZ), pursuant to
which we granted ANKE BIO an exclusive right to market, sell, distribute, and
promote SJ02 in Mainland China, Hong Kong, Macau, and Taiwan ( “ Greater
China”), and accordingly, ANKE BIO acts as an exclusive CSO responsible for the
commercialization of SJ02 in the same region.



As of June 30, 2026, SJ02 had completed online procurement platform listing and
market access procedures in more than 29 provinces across China and had covered
more than 70 medical institutions. As of the date of this announcement, ANKE BIO
has commenced actual commercial sales of SJ02 and is continuously advancing
hospital admission and formulary inclusion procedures for the product. We will
continue to work closely with ANKE BIO, our exclusive CSO partner, to optimize
the marketing strategy for SJ02, further strengthen the product’s market position,
reinforce its academic promotion capabilities and distribution network, and enhance
its market penetration and brand awareness.

Progress of Other Selected Clinical-Stage Products
•

KJ101 (Recombinant Human Chymotrypsin)


KJ101 is a leading recombinant human chymotrypsin developed through synthetic
biology in China. Chymotrypsin has exhibited a wide range of clinical applications,
particularly in wound healing for burn injuries, traumatic injuries, surgical
incision, pressure sores and diabetic foot ulcers, among others. Chymotrypsin, a
proteolytic enzyme, has historically been extracted from bovine pancreas tissue,
which poses challenges such as low yield, potential contamination and religious or
ethical concerns. Built upon our proprietary green recombinant yeast fermentation
technology, KJ101 provides a pure, safer and more scalable alternative with high
expression levels. Furthermore, KJ101 offers superior biosafety profile, effectively
addressing the viral contamination concerns inherent in biochemically extracted
counterparts.



For the wound-healing indications of burns, trauma, surgical incisions, pressure
ulcers, and diabetic foot ulcers, we initiated its Phase II clinical trial (CTR20252263)
in July 2025 and completed the trial in June 2026.



For the indication of KJ101 for the dissolution and removal of gastric mucus
during gastroscopy, we submitted the IND application to the NMPA in December
2025, received IND approval in March 2026, and initiated its Phase I clinical trial
(CTR20261865) in May 2026.

5

•

BJ044 (Recombinant Ulinastatin)


BJ044 is potentially the only recombinant ulinastatin developed through synthetic
biology in China and globally. Ulinastatin, also known as bikunin, is a glycoprotein
with strong inhibitory activity, first discovered in human urine in 1909. Ulinastatin
can be widely applied in the treatment of acute pancreatitis, acute exacerbation of
chronic recurrent pancreatitis, and acute circulatory failure. Owing to its potent
enzyme-inhibiting and anti-inflammatory properties, Ulinastatin has been widely used
in the treatment of a range of critical and life-threatening conditions with promising
clinical outcomes, including sepsis, severe pneumonia, acute respiratory distress
syndrome (ARDS), acute poisoning, severe heatstroke, burns and severe traumas.
Currently marketed ulinastatin products derived from human urine rely on an
unstandardized production process involving collecting and purifying urine, which
introduces risks of viral contamination and batch-to-batch quality inconsistencies.
In contrast, recombinant ulinastatin, such as BJ044, is designed to overcome these
limitations and deliver a more stable, efficient and scalable production method.
The recombinant technology utilized by BJ044 minimizes contamination risks and
improves clinical safety. It boasts the advantages of high purity, excellent batch
consistency and remarkable cost-effectiveness, while eliminating ethical concerns
associated with traditional biochemical extraction methods.


•

•

The IND application for BJ044 was submitted to the NMPA in March 2026 and was
approved by the NMPA in June 2026, permitting the commencement of clinical trials.

KJ015 (Bispecific Anti-HER2 Antibody (SC Formulations))


KJ015 is an SC formulation of an innovative bispecific anti-HER2 antibody derived
from common light chain technology, which is designed to have two Fab arms with
the common light chain forming a near-native IgG1 structure.



We received IND approval from the NMPA for KJ015 in December 2024 and
commenced the Phase I clinical trial (CTR20251923) in June 2025. We expect to
complete the Phase I clinical trial in the second half of 2026.



For overseas development, we submitted an IND application to the FDA in July 2026
and received the approval in August 2026 to commence clinical trials.

BJ007 (Ceftriaxone Sodium (SC Formulations))


BJ007 is an SC-administered ceftriaxone sodium formulation for the treatment of
bacterial infections. To date, there is no approved SC-administered ceftriaxone
sodium product globally, and BJ007 is the first and only drug candidate of this class
advanced to the clinical stage. The innovation reduces the need for vascular access
and use of long-term IV catheters, providing a more convenient, safer and lower-cost
administration option. BJ007 can thus offer non-inferior therapeutic benefits without
the risks, discomfort and costs associated with infusion lines that are routinely
required for longer courses of ceftriaxone treatment, while also overcoming key
treatment challenges for DIVA patients.

6



We received IND approval from the NMPA in February 2025. Upon approval, we
initiated a Phase I clinical trial (CTR20253085) for BJ007 in August 2025 and
completed the trial in January 2026. We are currently in communication with the
CDE regarding commencement of a pivotal clinical trial, with initiation anticipated in
the second half of 2026.



For overseas development, in May 2026, the IND application for BJ007 was approved
by the FDA, permitting the commencement of clinical trials. We expect to commence
the clinical trial in the second half of 2026.

Progress of Other Selected Products
•

•

BJ045 (Anti-CD20 Antibody Resistant to Enzyme Degradation (SC Formulations))


BJ045 is an SC-administered anti-CD20 antibody resistant to enzyme degradation by
KJ103 with the potential for the treatment of moderate-to-severe autoimmune diseases
when used in combination with KJ103. In combination with KJ103, it exerts a
synergistic effect by cleaving existing IgG antibodies, rapidly eliminating the damage
to normal tissues caused by pathogenic IgG antibodies and modulating pathogenic
IgG antibody production. In addition, leveraging our competitiveness in SC drug
delivery candidates, the SC administration modality of BJ045 could potentially
improve the treatment experience and patient compliance.



We submitted an IND application for BJ045 to the NMPA in July 2026 and expect to
obtain IND approval from the NMPA in the second half of 2026.

BJ047 (Anti-CD154 Antibody Resistant to Enzyme Degradation (SC Formulations))


BJ047 is an SC-administered anti-CD154 antibody resistant to enzyme degradation
by KJ103 developed for solid organ transplantation, xenotransplantation, and
autoimmune diseases (Lupus Nephritis, multiple sclerosis, IgG4-related disease,
among others). BJ047’s resistance to enzyme degradation further leads to increased
stability against breakdown by enzymes in the body, ensuring sustained immune
suppression and promoting xenograft survival over time. This contributes to a
synergistic effect in its target indications. For example, its use in combination with
KJ103, which effectively degrades anti-xenograft antibodies, will further contribute
to the reduction of both the source and effect of the pathogenic antibodies in
xenotransplantation. Additionally, with superior convenience and treatment flexibility,
BJ047 has the potential to stand out in the market as an innovative treatment option.



We expect to submit the IND application for BJ047 to the NMPA in the second half
of 2026.

7

8

Mono

Mono

Recombinant Human
Chorionic Gonadotropin

Recombinant Human
Chymotrypsin

Recombinant Ulinastatin

SJ04

KJ101

BJ044

Breakthrough Designation from the NMPA

Mono

Recombinant
Human FSH-CTP

SJ02
(Slonva®
(晟諾娃®))5,7

Lead Indication

Mono

Mono

Anti-CD154 Antibody Resistant
to Enzyme Degradation
(SC Formulations)

BJ047

Mono

Recombinant
IgG-Degrading
Enzyme

KJ1034

Mono

Mono

Bispecific Anti-HER2
Antibody
(SC Formulations)

KJ015

BJ045

Mono

Cefazolin Sodium
(SC Formulations)

BJ0093

Anti-CD20 Antibody Resistant
to Enzyme Degradation
(SC Formulations)

Mono

Cefoperazone Sodium
and Sulbactam Sodium
(SC Formulations)

Mono

Ceftriaxone Sodium
(SC Formulations)

BJ0073

BJ0083

Mono/Combo

Recombinant Human
Hyaluronidase2

KJ017
(葆舒宜®)1

1L

Pathological IgG-mediated
Autoimmune Diseases6

1L

1L

Acute Pancreatitis, Chronic
Recurrent Pancreatitis and
Acute Circulatory Failure

1L

The Dissolution and Removal
of Gastric Mucus During
Gastroscopy

1L

1L

Controlled Ovarian
Stimulation, Stimulating
Multiple Follicular
Development, Promoting
Ovulation

Wound Healing for Burn Injuries,
Traumatic Injuries, Surgical
Incision, Pressure Sores and
Diabetic Foot Ulcers, etc.

1L

Solid organ transplantation,
Xenotransplantation,
Autoimmune Disease
(Lupus Nephritis , Multiple Sclerosis,
IgG4-Related Disease, etc.)

Stimulating Follicular Maturation,
Inducing Ovulation and
Luteinization

1L

1L

Moderate-to-Severe
Autoimmune Diseases

GBS

1L

1L

Desensitization before
kidney transplantation

Anti-GBM Diseases

1L

1L

1L

1L

1L

Line(s) of
treatment

Solid Tumors

Bacterial Infection

Bacterial Infection

Bacterial Infection

Large-volume SC Delivery
(Combo), Body Fluid Loss due
to Various Causes (Mono),
Facilitation of SC fluid
administration (Combo)

Indications
Phase III

NDA

Chemical Drug

Improved Formulation of
Chemical Drug8

Chemical Drug

Improved Formulation of
Innovative Drug8

Biologics

Drug Classification

NMPA

NMPA

NMPA

NMPA

EMA

NMPA

NMPA

NMPA

NMPA

NMPA

FDA

NMPA

FDA

Biologics

Biologics

Biologics

Biologics

Biosimilar

Biologics

Biologics

Biologics

Biologics

Biologics

Innovative Biologics9

Biologics

Innovative Biologics9

Biologics

Phase II

NMPA

Phase I

Chemical Drug

IND

NMPA

NMPA

FDA

NMPA

EMA/FDA

NMPA

Preclinical

Received IND approval from the NMPA in June 2026;
Expect to initiate Phase I trial in 2026 H2

Phase I trial stage
Expect to complete Phase I trial in 2026 H2

Completed the Phase II trial in June 2026;
Expect to initiate Phase III trial in 2027

Completed the Phase I trial in September 2025

Preclinical stage;
Expect to submit IND application in 2027

Received NDA approval in August 2025

Preclinical stage;
Expect to submit IND application in 2026 H2

Submitted IND application in July 2026;
Expect to obtain IND approval in 2026 H2

Initiated Phase II trial in November 2025;
Expect to complete the patient enrollment in 2026 H2

Completed Phase II trial in October 2025
Expect to initiate Phase III trial in 2026 H2;
Received BTD from the NMPA in July 2025

CXSL2600415

CXSL2501119

CXSL2400781

CXSL2400176

國藥准字S20250049;
國藥准字S20250050

CXSL2500128

CXSL2400378

IND 160657

CXSL2200266

Submitted NDA application in June 2026;
Expect to receive NDA approval in 2027;
Received BTD from the NMPA in November 2024

Expect to communicate with the FDA
regarding commencement of a pivotal clinical trial in 2027

IND 181553

CXSL2400672

Received IND approval in August 2026

CXHL2500565

Phase I trial stage

IND 179838

CXHL2401399

國藥准字S20260020

IND/NDA Application/
Drug Approval No.

Phase I trial stage;
Expect to complete Phase I trial in 2026 H2

Preclinical stage

Received IND approval from the FDA in May 2026;
Expect to initiate clinical trial in 2026 H2

Completed Phase I trial in January 2026;
Expect to enter pivotal clinical trial in 2026 H2

Preclinical stage;
Expect to submit an IND application in 2026 H2

Received NDA approval in March 2026

Current Status/Milestone

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Source

Global

Global

Global

Global

Global

Global

Global

Global

Global

Global

Global

Global

Commercial
Rights

Abbreviations: BTD = Breakthrough Therapy Designation; FSH-CTP = Follicle-stimulating hormone-carboxyl-terminal peptide; GBM = Glomerular Basement
Membrane; GBS = Guillain-Barré syndrome; H1 = First Half; H2 = Second Half; IgG = Immunoglobulin G; SC = Subcutaneous.

Core Product

Synthetic Biology
Upgrading Platform

Assisted Reproduction

Antibody-mediated
Auto-immune
Diseases

Subcutaneous
Delivery

Regimen

Key Component

Candidate Drugs

The following diagram summarizes the development status of our selected drug candidates as of the date of this announcement:

Product Pipeline

9

We have remained the sole sponsor responsible for funding each phase of KJ017’s clinical development in China and expect to remain the sole sponsor for
KJ017’s future clinical development in Europe and the U.S.

We have completed the pharmaceutical excipient registration in China and are advancing the registration progress globally. The DMF for KJ017 was
successfully filed with the FDA in May 2025.

The subcutaneous antibiotic formulation is developed based on the Chemical Drug Modification (Category 2.2) new administration route, with subsequent
studies on area under the curve (AUC) equivalent and PK/PD.

We have remained the sole sponsor responsible for funding each phase of KJ103’s clinical development in China and expect to remain the sole sponsor for
KJ103’s future clinical development in the U.S.

We have remained the sole sponsor responsible for funding each phase of SJ02’s clinical development in China and expect to remain the sole sponsor for
SJ02’s future clinical development in Europe.

Pathological IgG-mediated Autoimmune Diseases refer to a group of disorders in which the immune system produces abnormal IgG antibodies that target the
body’s own cells, tissues, or organs.

We entered into an exclusive sales agency agreement with ANKE BIO in July 2025, pursuant to which ANKE BIO acts as an exclusive CSO responsible for
the commercialization of SJ02 in Greater China.

This definition is established under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

This definition is established under Section 351(a) of the Public Health Service Act.

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

Notes:

FINANCIAL HIGHLIGHTS
Six months ended June 30,
2026
2025
(Audited)
(Unaudited)
RMB ’000
RMB ’000
(92,570)
(40,616)
(153,685)

Research and development expenses
Administrative expenses
Loss for the period

(111,045)
(46,153)
(183,096)

Our research and development expenses decreased by RMB18.5 million, or 16.6%, from
RMB111.0 million for the six months ended June 30, 2025 to RMB92.6 million for the six
months ended June 30, 2026. This decrease was primarily attributable to: (i) a RMB20.1 million
reduction in share-based payment expenses associated with equity incentives granted to our R&D
personnel, partially offset by (ii) a RMB13.8 million increase in trial and testing expenses as we
advanced the ongoing clinical development of our drug candidates.
Our administrative expenses decreased by RMB5.5 million, or 12.0%, from RMB46.2 million
for the six months ended June 30, 2025 to RMB40.6 million for the six months ended June
30, 2026. This decrease was primarily due to the reduction in share-based payment expenses
incurred from our grant of share incentives to management and administrative personnel.

Cash and cash equivalents
Total assets
Total equity

As at
June 30,
2026
(Unaudited)
RMB ’000

As at
December 31,
2025
(Audited)
RMB ’000

1,042,096
2,169,835
1,448,724

1,241,609
2,216,979
1,591,974

Other Highlights


In April 2026, following recommendation by the Shanghai Federation of Trade Unions, the
Company received the National May 1 Labor Certificate (全國五一勞動獎狀) at a national
ceremony and was one of 25 enterprises in Shanghai to receive the award.

10

MANAGEMENT DISCUSSION AND ANALYSIS
BUSINESS OVERVIEW
Founded in 2019, we are a biotechnology company strategically focused on four areas: (i)
large-volume subcutaneous (SC) drug delivery; (ii) antibody-mediated autoimmune conditions; (iii)
assisted reproduction; and (iv) recombinant biologic products. Our portfolio primarily consists of
12 self-developed products and product candidates, comprising three Core Products (KJ017 (葆
舒宜 ®), KJ103 and SJ02 (Slonva® (晟諾娃 ®))), six other clinical-stage candidates (KJ101, BJ044,
KJ015, BJ007, BJ009, and SJ04), and three preclinical assets (BJ045, BJ047 and BJ008). Our
Core Products comprise: (i) KJ017 (葆舒宜 ®), a recombinant human hyaluronidase, the 385U/
vial dosage strength of which was approved for marketing by the NMPA in March 2026 for use
as an adjuvant to subcutaneous infusion, including Sodium Chloride Injection and Sodium Lactate
Ringer’s Injection; (ii) KJ103, an innovative recombinant immunoglobulin G (IgG)-degrading
enzyme, the NDA for which was included in the priority review and approval procedure in May
2026 and accepted by the NMPA in June 2026 for desensitization therapy in highly sensitized
kidney transplant patients; and (iii) SJ02 (Slonva® (晟諾娃 ®)), a long-acting recombinant human
follicle-stimulating hormone carboxyl-terminal peptide fusion protein (FSH-CTP) for assisted
reproduction, which received NDA approval from the NMPA in August 2025.

11

12

Mono

Mono

Recombinant Human
Chorionic Gonadotropin

Recombinant Human
Chymotrypsin

Recombinant Ulinastatin

SJ04

KJ101

BJ044

Breakthrough Designation from the NMPA

Mono

Recombinant
Human FSH-CTP

SJ02
(Slonva®
(晟諾娃®))5,7

Lead Indication

Mono

Mono

Anti-CD154 Antibody Resistant
to Enzyme Degradation
(SC Formulations)

KJ1034

BJ047

Mono

Recombinant
IgG-Degrading
Enzyme

KJ015

Mono

Mono

Bispecific Anti-HER2
Antibody
(SC Formulations)

BJ0093

BJ045

Mono

Cefazolin Sodium
(SC Formulations)

Anti-CD20 Antibody Resistant
to Enzyme Degradation
(SC Formulations)

Mono

Cefoperazone Sodium
and Sulbactam Sodium
(SC Formulations)

Mono

Ceftriaxone Sodium
(SC Formulations)

BJ0073

BJ0083

Mono/Combo

Recombinant Human
Hyaluronidase2

KJ017
(葆舒宜®)1

Indications

1L

Pathological IgG-mediated
Autoimmune Diseases6

1L

1L

Acute Pancreatitis, Chronic
Recurrent Pancreatitis and
Acute Circulatory Failure

1L

The Dissolution and Removal
of Gastric Mucus During
Gastroscopy

1L

1L

Controlled Ovarian
Stimulation, Stimulating
Multiple Follicular
Development, Promoting
Ovulation

Wound Healing for Burn Injuries,
Traumatic Injuries, Surgical
Incision, Pressure Sores and
Diabetic Foot Ulcers, etc.

1L

Solid organ transplantation,
Xenotransplantation,
Autoimmune Disease
(Lupus Nephritis , Multiple Sclerosis,
IgG4-Related Disease, etc.)

Stimulating Follicular Maturation,
Inducing Ovulation and
Luteinization

1L

1L

Moderate-to-Severe
Autoimmune Diseases

GBS

1L

1L

Desensitization before
kidney transplantation

Anti-GBM Diseases

1L

1L

1L

1L

1L

Line(s) of
treatment

Solid Tumors

Bacterial Infection

Bacterial Infection

Bacterial Infection

Large-volume SC Delivery
(Combo), Body Fluid Loss due
to Various Causes (Mono),
Facilitation of SC fluid
administration (Combo)

Phase III

NDA

Chemical Drug

Improved Formulation of
Chemical Drug8

Chemical Drug

Improved Formulation of
Innovative Drug8

Biologics

Drug Classification

NMPA

NMPA

NMPA

NMPA

EMA

NMPA

NMPA

NMPA

NMPA

NMPA

FDA

NMPA

FDA

Biologics

Biologics

Biologics

Biologics

Biosimilar

Biologics

Biologics

Biologics

Biologics

Biologics

Innovative Biologics9

Biologics

Innovative Biologics9

Biologics

Phase II

Chemical Drug

Phase I

NMPA

IND

NMPA

NMPA

FDA

NMPA

EMA/FDA

NMPA

Preclinical

Received IND approval from the NMPA in June 2026;
Expect to initiate Phase I trial in 2026 H2

Phase I trial stage
Expect to complete Phase I trial in 2026 H2

Completed the Phase II trial in June 2026;
Expect to initiate Phase III trial in 2027

Completed the Phase I trial in September 2025

Preclinical stage;
Expect to submit IND application in 2027

Received NDA approval in August 2025

Preclinical stage;
Expect to submit IND application in 2026 H2

Submitted IND application in July 2026;
Expect to obtain IND approval in 2026 H2

Initiated Phase II trial in November 2025;
Expect to complete the patient enrollment in 2026 H2

Completed Phase II trial in October 2025
Expect to initiate Phase III trial in 2026 H2;
Received BTD from the NMPA in July 2025

CXSL2600415

CXSL2501119

CXSL2400781

CXSL2400176

國藥准字S20250049;
國藥准字S20250050

CXSL2500128

CXSL2400378

IND 160657

CXSL2200266

Submitted NDA application in June 2026;
Expect to receive NDA approval in 2027;
Received BTD from the NMPA in November 2024

Expect to communicate with the FDA
regarding commencement of a pivotal clinical trial in 2027

IND 181553

CXSL2400672

Received IND approval in August 2026

CXHL2500565

Phase I trial stage

IND 179838

CXHL2401399

國藥准字S20260020

IND/NDA Application/
Drug Approval No.

Phase I trial stage;
Expect to complete Phase I trial in 2026 H2

Preclinical stage

Received IND approval from the FDA in May 2026;
Expect to initiate clinical trial in 2026 H2

Completed Phase I trial in January 2026;
Expect to enter pivotal clinical trial in 2026 H2

Preclinical stage;
Expect to submit an IND application in 2026 H2

Received NDA approval in March 2026

Current Status/Milestone

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Self-developed

Source

Global

Global

Global

Global

Global

Global

Global

Global

Global

Global

Global

Global

Commercial
Rights

Abbreviations: BTD = Breakthrough Therapy Designation; FSH-CTP = Follicle-stimulating hormone-carboxyl-terminal peptide; GBM = Glomerular Basement
Membrane; GBS = Guillain-Barré syndrome; H1 = First Half; H2 = Second Half; IgG = Immunoglobulin G; SC = Subcutaneous.

Core Product

Synthetic Biology
Upgrading Platform

Assisted Reproduction

Antibody-mediated
Auto-immune
Diseases

Subcutaneous
Delivery

Regimen

Key Component

Candidate Drugs

The following diagram summarizes the development status of our selected drug candidates as of the date of this announcement:

Product Pipeline

13

We have remained the sole sponsor responsible for funding each phase of KJ017’s clinical development in China and expect to remain the sole sponsor for
KJ017’s future clinical development in Europe and the U.S.

We have completed the pharmaceutical excipient registration in China and are advancing the registration progress globally. The DMF for KJ017 was successfully
filed with the FDA in May 2025.

The subcutaneous antibiotic formulation is developed based on the Chemical Drug Modification (Category 2.2) new administration route, with subsequent studies
on area under the curve (AUC) equivalent and PK/PD.

We have remained the sole sponsor responsible for funding each phase of KJ103’s clinical development in China and expect to remain the sole sponsor for
KJ103’s future clinical development in the U.S.

We have remained the sole sponsor responsible for funding each phase of SJ02’s clinical development in China and expect to remain the sole sponsor for SJ02’s
future clinical development in Europe.

Pathological IgG-mediated Autoimmune Diseases refer to a group of disorders in which the immune system produces abnormal IgG antibodies that target the
body’s own cells, tissues, or organs.

We entered into an exclusive sales agency agreement with ANKE BIO in July 2025, pursuant to which ANKE BIO acts as an exclusive CSO responsible for the
commercialization of SJ02 in Greater China.

This definition is established under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

This definition is established under Section 351(a) of the Public Health Service Act.

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

Notes:

Our Product Candidates
During the Reporting Period and up to the date of this announcement, we continued advancing the
development of our pipeline. Our key achievements and planned next steps as of the date of this
announcement include:
•

KJ017 (Recombinant Human Hyaluronidase)


KJ017 is a highly glycosylated recombinant human hyaluronidase that can specifically
degrade hyaluronic acid in subcutaneous tissue and temporarily and locally increase
the permeability of the extracellular matrix in subcutaneous tissue, thereby enabling
safe, rapid and large-volume subcutaneous administration and providing a new option
to address drug administration challenges for patients with difficult intravenous access.
Compared with conventional animal-derived hyaluronidase, which carries a risk of
allergic reactions, requires skin testing prior to use, and is subject to inconsistent quality
between batches, KJ017 adopts recombinant gene technology and, through a controlled
manufacturing process, can achieve a high degree of batch-to-batch consistency,
improve safety, and significantly reduce immunogenicity risk. No skin test is required
before use, thereby enhancing the convenience and safety of clinical use.



KJ017 is the most advanced recombinant human hyaluronidase in China. In March
2026, our internally developed Human Hyaluronidase for Injection (葆舒宜 ®), in the
385U/vial dosage strength, was approved for marketing by the NMPA for use as an
adjuvant to subcutaneous infusion, including Sodium Chloride Injection and Sodium
Lactate Ringer’s Injection.



As of the date of this announcement, we had achieved the following progress and
milestones, and we outline our planned next steps below:
o

We submitted the NDA application for KJ017 to the NMPA in 2024. In 2025, we
passed the NMPA GCP inspection of the hospital and bioanalytical laboratory
conducting the KJ017 clinical trial, and cleared the NMPA pre-approval GMP
compliance inspection for KJ017. In March 2026, our internally developed Human
Hyaluronidase for Injection (葆舒宜 ®), in the 385U/vial dosage strength, was
approved for marketing by the NMPA for use as an adjuvant to subcutaneous
infusion, including Sodium Chloride Injection and Sodium Lactate Ringer’ s
Injection.

o

During the Reporting Period, results from two randomized, double-blind,
self-controlled Phase III clinical trials of KJ017 were published in the European
Journal of Pharmaceutics and Biopharmaceutics . The results showed that KJ017
enhanced gravity-driven SC infusion performance while maintaining favorable
safety and tolerability. By increasing SC tissue permeability, KJ017 enabled the
delivery of clinically relevant fluid volumes through the SC route across multiple
anatomical sites. These findings support the further development of KJ017 as an
adjunct for large-volume SC administration and its potential co-administration
with therapeutic agents requiring rapid or high-volume SC delivery.

14

o

We will continue to advance commercialization preparations for KJ017
in an orderly manner while evaluating and selecting the most appropriate
commercialization model, including potential collaborations with specialized
commercialization service providers or leading biopharmaceutical companies
with established promotion capabilities. We expect to leverage the extensive
sales networks, established distribution channels and commercialization
expertise of selected partners to support market access, medical affairs, channel
management and subsequent commercialization of KJ017 across different regions,
thereby broadening its market coverage. In selecting potential partners, we will
comprehensively assess factors including product accessibility and the competitive
landscape, with a view to realizing the clinical and commercial value of KJ017.

o

As of the date of this announcement, we had established formal collaboration
partnerships with multiple pharmaceutical and biotechnology companies
(including, among others, WuXi Biologics (2269.HK), Qyuns (2509.HK),
Shanghai RAAS (002252.SZ), and Sumgen) to co-develop subcutaneous
formulations. In addition to the collaborations disclosed above, we continue to
proactively expand our collaboration ecosystem. More than 60 partners have used
our recombinant human hyaluronidase in their product development, with projects
at various stages ranging from early-stage research to clinical development. As
such collaborations are subject to confidentiality obligations, details thereof have
not been disclosed in this announcement. Under our typical collaboration model,
we continuously supply our recombinant human hyaluronidase product as an
excipient and provide related technical services, while our partners independently
fund the development of subcutaneous formulations used in combination with their
product candidates.


In January 2026, we and Guangxi Laishi Biopharmaceutical Co., Ltd. (廣
西萊士生物製藥有限公司), a wholly-owned subsidiary of Shanghai RAAS
(002252.SZ), jointly announced that the parties had entered into a strategic
cooperation in relation to the development of new blood product formulations
based on hyaluronidase-enabled subcutaneous administration technology.
Pursuant to the agreement, the parties will leverage the Company ’ s
subcutaneous drug delivery technology platform together with the leading
strengths of Shanghai RAAS in the blood products sector to jointly develop
novel blood product treatment solutions with enhanced convenience and
improved patient friendliness, with the aim of improving patient compliance
and optimizing the utilization of healthcare resources.



In January 2025, we entered into a strategic cooperation agreement with
WuXi Biologics (Shanghai) Co., Ltd. (上海藥明生物技術有限公司), a
wholly-owned subsidiary of WuXi Biologics (2269.HK), in relation to the
supply, manufacturing and licensing of recombinant human hyaluronidase.
Pursuant to the agreement, the Company and WuXi Biologics intend to
achieve mutually beneficial cooperation in the application of recombinant
human hyaluronidase for subcutaneous drug delivery, and to jointly pursue
in-depth development of new business opportunities and expansion of new
customer channels.

15



In August 2024, we entered into a technology services and supply agreement
with Qyuns for the joint development of innovative SC formulations of
original biologic products selected by Qyuns and owned, being developed
or to be developed by it, in combination with our recombinant human
hyaluronidase. Qyuns, an Independent Third Party to us, is a leading
biotechnology company exclusively focused on biologic therapies for
autoimmune and allergic diseases.
Pursuant to this agreement, Qyuns will be the marketing authorization holder
for the SC formulations developed under this agreement and enjoy exclusive
rights to the development, manufacturing and commercialization thereof,
while bearing all related costs. We agreed to supply recombinant human
hyaluronidase for product development, provide necessary technical support,
and assist in regulatory filings.

o

In May 2025, the DMF for KJ017 was successfully filed with the FDA. We plan
to submit IND applications for KJ017 to the European Medicines Agency (EMA)
and the FDA, and are in the process of simultaneously preparing both EMA and
FDA IND filings. We anticipate submitting the application to the FDA in the
second half of 2026 and will subsequently complete the IND application for the
other region. Our KJ017 exhibits broad applications across multiple therapeutic
modalities to enable SC administration, including antibodies and chemicals
especially antibiotics, with the potential to enhance drug safety profiles, patient
convenience and efficacy.

Warning under Rule 18A.08(3) of the Listing Rules: There is no assurance that KJ017 will be
successfully commercialized in China or that KJ017 will ultimately be successfully developed and
marketed for additional indications, formulations or in overseas markets.
•

KJ103 (Recombinant IgG-Degrading Enzyme)


KJ103 is a globally first-in-class, low-immunogenicity innovative recombinant
immunoglobulin G ( “ IgG ” )-degrading enzyme for the treatment of various
immune-mediated diseases and conditions driven by pathogenic IgG antibodies. KJ103
specifically cleaves IgG at a specific site in the hinge region between CH1 and CH2
by binding to the CH2 domain in the constant region of IgG. With a well-defined
mechanism of action and a low immunogenicity risk, KJ103 can safely, efficiently,
rapidly and specifically degrade human IgG.



KJ103 is the first and only low-immunogenicity IgG-degrading enzyme to reach
the registrational clinical stage globally, and has obtained Breakthrough Therapy
Designation ( “ BTD ” ) from the NMPA both as a desensitization therapy in kidney
transplantation and for the treatment of anti-GBM disease. KJ103 is designed to target
and degrade IgG antibodies in the blood and tissues, thereby inhibiting pathogenic
IgG-mediated immune responses that cause various immunological conditions.

16



As of the date of this announcement, we had achieved the following progress and
milestones, and we outline our planned next steps below:
o

For desensitization before kidney transplantation, we initiated the Phase III clinical
trial (CTR20252973) in August 2025, and completed the primary trial follow-up
for all enrolled subjects in March 2026. Subsequent to the submission in May
2026, the NDA was included in the priority review and approval procedure by the
Center for Drug Evaluation of the NMPA in the same month, and was accepted by
the NMPA in June 2026. We expect to receive the NDA approval in 2027.
In the Phase III clinical trial (CTR20252973) of KJ103 for desensitization
treatment in highly sensitized kidney transplant patients completed in March
2026, KJ103 met the primary endpoint and demonstrated a rapid and significant
desensitization effect. The data showed a 100% success rate in desensitization
therapy prior to transplantation and a 100% success rate in kidney transplantation,
with no hyperacute rejection observed. KJ103 also demonstrated a favorable safety
profile, with no KJ103-related serious adverse events reported.

o

For the anti-GBM disease indication, we convened the Phase III clinical trial
investigator meeting in January 2026. We expect to initiate the Phase III clinical
trial in the second half of 2026.
In the Phase II clinical trial (CTR20243543) of KJ103 for anti-GBM disease, the
3-month overall survival rate was 100.0% and 66.7% of patients were dialysis
independent with preserved renal function. At 6.0 months after KJ103 treatment,
overall survival was 100.0% and 75.0% of patients were dialysis independent with
preserved renal function. A comparative efficacy analysis versus historical data
indicated that KJ103 demonstrated a clear clinical advantage. Historical data for
patients receiving current standard intensive therapy showed a 3.0-month overall
survival rate of 81.2%, with only 30.6% of patients being dialysis independent
with preserved renal function. KJ103 had a favorable safety profile, with no
drug-related serious adverse events reported.
In June 2026, results from the Phase II, open-label, single-arm, multicenter study
of early repeated administration of KJ103 (Ricefidase) in patients with anti-GBM
disease were presented at the 63rd Congress of the European Renal Association
(ERA). The study indicated that KJ103 enabled highly efficient, rapid, and
sustained clearance of anti-GBM antibodies, with potential clinical benefits in key
outcomes, thereby providing a novel direction for therapeutic exploration in this
life-threatening rare autoimmune disease.

o

For the GBS indication, we initiated the Phase II clinical trial in November 2025
and expect to complete the patient enrollment in the second half of 2026.

17

o

In November 2025, the Company was awarded a pivotal task under the National
Science and Technology Major Project “Medical-Grade Donor Pig Breeding and
Clinical Translation of Xenotransplantation,” taking on a critical role in providing
the key drugs essential for overall clinical translation. During the project,
leveraging our R&D strengths in recombinant enzymes and immunomodulatory
drugs, we provided multiple critical immunotherapeutic agents that supported
the long-term survival of the xenogeneic kidney transplant. As of the date of
this announcement, the recipient monkey has survived for more than 660 days
with stable renal graft function, representing a new Asia record for the long-term
survival of non-human primates following xenogeneic kidney transplantation. This
achievement demonstrates our ability to provide key support for the exploration
and innovation of immunological intervention strategies for xenotransplantation,
as well as the potential to contribute to the future development of
xenotransplantation.

o

For KJ103’s overseas program targeting pathogenic IgG-mediated autoimmune
diseases, we submitted an Orphan Drug Designation (ODD) application to the
FDA for the GBS indication in August 2026 and expect to communicate with the
FDA regarding commencement of a pivotal clinical trial in 2027.

Warning under Rule 18A.08(3) of the Listing Rules: There is no assurance that KJ103 will
ultimately be successfully developed and marketed by our Company.
•

SJ02 (Slonva ® (晟諾娃 ®)) (Long-acting Recombinant Human FSH-CTP)


SJ02 is a long-acting recombinant human follicle-stimulating hormone
carboxyl-terminal peptide fusion protein (FSH-CTP) designed for controlled ovarian
stimulation in combination with a gonadotropin-releasing hormone antagonist approved
in China. SJ02 is the first approved long-acting FSH-CTP product in China.
The treatment regimen of SJ02 effectively stimulates multiple follicular development
in females undergoing superovulation or assisted reproductive technology procedures.
Built upon the traditional short-acting FSH, SJ02 has been structurally enhanced by
fusing the CTP sequence of human chorionic gonadotropin subunit to the C-terminus of
the FSH subunit. This modification significantly prolongs the in vivo half-life of FSH
by two to three times without affecting its functionality. The long-acting nature of SJ02
enables a single injection to replace up to seven days of daily injections required with
short-acting FSH. By extending the dosing interval from daily to weekly, SJ02 can offer
greater convenience, minimize injection-related discomfort, and enhance the overall
treatment experience and quality of life for patients.

18



As of the date of this announcement, we had achieved the following progress and
milestones, and we outline our planned next steps below:
o

In China, we received the NDA approval for SJ02 under the approved drug
name Corifollitropin alfa N01 Injection (Slonva® (晟諾娃 ®)) in August 2025 and
completed the delivery of the first order in November 2025.
In July 2025, we entered into an exclusive sales agency agreement with an
independent third party, ANKE BIO, pursuant to which we granted ANKE
BIO an exclusive right to market, sell, distribute, and promote SJ02 in Greater
China, and accordingly, ANKE BIO acts as an exclusive CSO responsible for
the commercialization of SJ02 in the same region. As of June 30, 2026, SJ02
had completed online procurement platform listing and market access procedures
in more than 29 provinces across China and had covered more than 70 medical
institutions. As of the date of this announcement, ANKE BIO has commenced
actual commercial sales of SJ02 and is continuously advancing hospital admission
and formulary inclusion procedures for the product. We will continue to work
closely with ANKE BIO, our exclusive CSO partner, to optimize the marketing
strategy for SJ02, further strengthen the product’s market position, reinforce its
academic promotion capabilities and distribution network, and enhance its market
penetration and brand awareness.

o

In Europe, we plan to submit an IND application for SJ02 to the EMA in 2027.

Warning under Rule 18A.08(3) of the Listing Rules: There is no assurance that the successful
commercialization of SJ02 in Greater China will continue or that SJ02 will ultimately be
successfully developed and marketed in overseas markets.
•

KJ101 (Recombinant Human Chymotrypsin)


KJ101 is a leading recombinant human chymotrypsin developed through synthetic
biology in China. Chymotrypsin has exhibited a wide range of clinical applications,
particularly in wound healing for burn injuries, traumatic injuries, surgical incisions,
pressure sores and diabetic foot ulcers, among others. Chymotrypsin, a proteolytic
enzyme, has historically been extracted from bovine pancreas tissue, which poses
challenges such as low yield, potential contamination and religious or ethical concerns.
Built upon our proprietary green recombinant yeast fermentation technology, KJ101
provides a pure, safer and more scalable alternative with high expression levels.
Furthermore, KJ101 offers a superior biosafety profile, effectively addressing the viral
contamination concerns inherent in biochemically extracted counterparts.



For the wound-healing indications of burns, trauma, surgical incisions, pressure ulcers,
and diabetic foot ulcers, we received IND approval for KJ101 from the NMPA in
February 2025, initiated its Phase II clinical trial (CTR20252263) in July 2025 and
completed the trial in June 2026. We expect to commence the Phase III clinical trial in
2027.



For the indication of dissolution and removal of gastric mucus during gastroscopy, we
submitted the IND application to the NMPA in December 2025, received IND approval
in March 2026, and initiated its Phase I clinical trial (CTR20261865) in May 2026. We
expect to complete the Phase I clinical trial in the second half of 2026.
19

•

BJ044 (Recombinant Ulinastatin)


BJ044 is potentially the only recombinant ulinastatin developed through synthetic
biology in China and globally. Ulinastatin, also known as bikunin, is a glycoprotein
with strong inhibitory activity, first discovered in human urine in 1909. Ulinastatin
can be widely applied in the treatment of acute pancreatitis, acute exacerbation of
chronic recurrent pancreatitis, and acute circulatory failure. Owing to its potent
enzyme-inhibiting and anti-inflammatory properties, Ulinastatin has been widely used
in the treatment of a range of critical and life-threatening conditions with promising
clinical outcomes, including sepsis, severe pneumonia, acute respiratory distress
syndrome (ARDS), acute poisoning, severe heatstroke, burns and severe traumas.
Currently marketed ulinastatin products derived from human urine rely on an
unstandardized production process involving collecting and purifying urine, which
introduces risks of viral contamination and batch-to-batch quality inconsistencies.
In contrast, recombinant ulinastatin, such as BJ044, is designed to overcome these
limitations and deliver a more stable, efficient and scalable production method. The
recombinant technology utilized by BJ044 minimizes contamination risks and improves
clinical safety. It boasts the advantages of high purity, excellent batch consistency
and remarkable cost-effectiveness, while eliminating ethical concerns associated with
traditional biochemical extraction methods.



•

•

The IND application for BJ044 was submitted to the NMPA in March 2026 and was
approved by the NMPA in June 2026, permitting the commencement of clinical trials.
We expect to commence the Phase I clinical trial in the second half of 2026.

KJ015 (Bispecific Anti-HER2 Antibody (SC Formulations))


KJ015 is an SC formulation of an innovative bispecific anti-HER2 antibody derived
from common light chain technology, which is designed to have two Fab arms with the
common light chain forming a near-native IgG1 structure.



We received IND approval from the NMPA for KJ015 in December 2024 and
commenced the Phase I clinical trial (CTR20251923) in June 2025. We expect to
complete the Phase I clinical trial in the second half of 2026.



For overseas development, we submitted an IND application to the FDA in July 2026
and received the approval in August 2026 to commence clinical trials.

BJ045 (Anti-CD20 Antibody Resistant to Enzyme Degradation (SC Formulations))


BJ045 is an SC-administered anti-CD20 antibody resistant to enzyme degradation
by KJ103 with the potential for the treatment of moderate-to-severe autoimmune
diseases when used in combination with KJ103. In combination with KJ103, it exerts a
synergistic effect by cleaving existing IgG antibodies, rapidly eliminating the damage
to normal tissues caused by pathogenic IgG antibodies and modulating pathogenic IgG
antibody production. In addition, leveraging our competitiveness in SC drug delivery
candidates, the SC administration modality of BJ045 could potentially improve the
treatment experience and patient compliance.

20


•

•

We submitted an IND application for BJ045 to the NMPA in July 2026 and expect to
obtain IND approval from the NMPA in the second half of 2026.

BJ047 (Anti-CD154 Antibody Resistant to Enzyme Degradation (SC Formulations))


BJ047 is an SC-administered anti-CD154 antibody resistant to enzyme degradation by
KJ103 developed for solid organ transplantation, xenotransplantation, and autoimmune
diseases (Lupus Nephritis, multiple sclerosis, IgG4-related disease, among others).
BJ047’s resistance to enzyme degradation further leads to increased stability against
breakdown by enzymes in the body, ensuring sustained immune suppression and
promoting xenograft survival over time. This contributes to a synergistic effect in its
target indications. For example, its use in combination with KJ103, which effectively
degrades anti-xenograft antibodies, will further contribute to the reduction of both the
source and effect of the pathogenic antibodies in xenotransplantation. Additionally, with
superior convenience and treatment flexibility, BJ047 has the potential to stand out in
the market as an innovative treatment option.



We expect to submit an IND application for BJ047 to the NMPA in the second half of
2026.

BJ007 (Ceftriaxone Sodium (SC Formulations))


BJ007 is an SC-administered ceftriaxone sodium formulation for the treatment of
bacterial infections. To date, there is no approved SC-administered ceftriaxone
sodium product globally, and BJ007 is the first and only drug candidate of this class
advanced to the clinical stage. The innovation reduces the need for vascular access
and use of long-term IV catheters, providing a more convenient, safer and lower-cost
administration option. BJ007 can thus offer non-inferior therapeutic benefits without the
risks, discomfort and costs associated with infusion lines that are routinely required for
longer courses of ceftriaxone treatment, while also overcoming key treatment challenges
for DIVA patients.



We received IND approval from the NMPA in February 2025. Upon approval, we
initiated a Phase I clinical trial (CTR20253085) for BJ007 in August 2025 and
completed the trial in January 2026. We are currently in communication with the CDE
regarding commencement of a pivotal clinical trial, with initiation anticipated in the
second half of 2026.



For overseas development, in May 2026, the IND application for BJ007 was approved
by the FDA, permitting the commencement of clinical trials. The approved clinical trial
is a randomized, open-label clinical trial to evaluate the pharmacokinetic characteristics,
absolute bioavailability and PK/PD efficacy of subcutaneous infusion of BJ007
compared with intravenous infusion of ceftriaxone sodium in healthy participants. We
expect to commence the clinical trial in the second half of 2026.

21

•

•

•

BJ008 (Cefoperazone Sodium and Sulbactam Sodium (SC Formulations))


BJ008 is an innovative SC formulation of cefoperazone sodium and sulbactam
sodium. The combination of cefoperazone sodium and sulbactam sodium is a common
compound preparation for the treatment of bacterial infections spanning respiratory tract
infection, urinary tract infections, intra-abdominal infections, gynecological infections,
skin and soft tissue infections, bone and joint infections, bacterial sepsis, meningitis,
endocarditis, as well as surgical prophylaxis. Cefoperazone, a third-generation
cephalosporin antibiotic, demonstrates strong synergistic antibacterial activity against
Gram-negative bacteria with good stability when combined with sulbactam sodium,
an irreversible beta-lactamase inhibitor. By utilizing our large-volume SC delivery
system, BJ008 may have the potential to replace the IV infusion of currently available
cefoperazone sodium and sulbactam sodium with subcutaneous injection, with a reduced
risk of complications and improved patient compliance.



We will actively advance the preclinical research of BJ008 as planned.

BJ009 (Cefazolin Sodium (SC Formulations))


BJ009 is designed as an innovative SC formulation of cefazolin sodium, a
first-generation cephalosporin antibiotic that works by inhibiting bacterial cell wall
synthesis, leading to cell lysis. Similar to intravenous cefazolin sodium, BJ009 has
the potential to treat a wide range of infections caused by bacteria, including those
affecting the skin, bone, joint, genital, blood, heart valve, respiratory tract, biliary tract,
and urinary tract infections. Moreover, the SC administration of BJ009 may offer an
enhanced treatment experience, lower risks of complications and reduced treatment
costs, suggesting its market potential.



We submitted an IND application for BJ009 in May 2025 and received IND approval
from the NMPA in September 2025. Upon approval, we initiated a Phase I clinical trial
for BJ009 (CTR20255246) in December 2025. We plan to keep advancing the Phase I
clinical trial for BJ009.

SJ04 (Recombinant Human Chorionic Gonadotropin)


SJ04 is a recombinant human chorionic gonadotropin (hCG) and can be used
in assisted reproductive procedures to accelerate follicle maturation and induce
ovulation. Additionally, it is suitable for treating prepubertal cryptorchidism, male
hypogonadotropic hypogonadism, luteal phase deficiency, and dysfunctional uterine
bleeding. In females, SJ04 promotes follicular maturation and triggers ovulation,
while facilitating the transformation of ruptured follicles into functional corpora lutea
for enhanced progesterone secretion. Thus, it enhances endometrial development for
improved reproductive outcomes in people with luteal phase deficiency and helps
establish regular menstrual cycles through normalized hormonal patterns for people with
dysfunctional uterine bleeding.



We obtained the IND approval from the NMPA for SJ04 in May 2024. Subsequently,
we commenced a Phase I clinical trial for SJ04 in August 2024 in China and completed
the patient enrollment in August 2025. We completed the Phase I clinical trial in
September 2025. Following recent regulatory developments for biosimilar drugs, we are
communicating with the relevant regulatory authority regarding the subsequent clinical
development plan.
22

Warning under Rule 18A.08(3) of the Listing Rules: There is no assurance that KJ101, BJ044,
KJ015, BJ045, BJ047, BJ007, BJ008, BJ009 and SJ04 will ultimately be successfully developed
and marketed by our Company.
Our proprietary technology platforms
Leveraging our strengths in synthetic biology technology, we have had the foresight to build fully
integrated in-house R&D and manufacturing capabilities. To date, we operate three technology
platforms spanning across drug design, chassis cell engineering, and comprehensive bioprocessing,
which allow us to navigate the intricate processes of bringing our transformative recombinant
protein drugs from bench to bedside. Specifically, our three technology platforms consist of:
•

Drug Design Platform: Our approach to drug design centers on developing customized
delivery systems and formulations that align with the unique properties of the drug and
specific needs of the target patient population. We prioritize immunogenicity, molecular
stability, and cost-effective production in drug development. Leveraging AI-powered models,
we integrate advanced computational simulations with rigorous experimental validation
to achieve precise protein engineering and functional optimization. Data generated from
wet-lab experiments is continuously fed back into our models to refine and enhance their
performance, thereby fostering an iterative and adaptive design process. As a result, KJ103,
one of our Core Products, emerged from our drug design platform as a candidate composed of
complex enzymes with exceptional stability and functionality, exemplifying its translational
power.

•

Chassis Cell Engineering Platform: Our chassis cell engineering platform focuses on
glycosylation modification and advanced expression technologies. Drawing on our extensive
expertise in enzyme engineering, glycoengineering, and synthetic biology, we have achieved
key breakthroughs in various fields, such as the regulation of protein translation and
post-translational modifications for recombinant human hyaluronidase, Chinese hamster
ovary (CHO) cell glycosylation engineering, and protein high-expression technologies.
We adopt a multidisciplinary approach across three major biopharmaceutical host systems
— including E. coli, Pichia pastoris, and CHO cell systems – to design bioparts, engineer
metabolic pathways, and screen drug proteins from modified hosts. This approach allows
us to express proteins in the most suitable host based on the structural and functional
requirements of a specific drug protein, thereby significantly shortening the development
cycle for novel therapeutics.
In particular, we have developed a CHO cell library with engineered glycosyltransferases to
produce humanized glycoproteins with enhanced structural uniformity. This notably reduces
immunogenicity, extends half-life, and improves therapeutic efficacy. Additionally, our
Pichia pastoris cell library features expression chaperones and optimized hosts ready for
immediate use in new project process research, which streamlines our drug production and
accelerates project timelines.

•

Comprehensive Bioprocessing Platform: Our comprehensive bioprocessing platform
integrates mammalian, yeast, and E. coli expression systems to support large-scale,
efficient, and sustainable production of our recombinant protein drugs. We optimize
production processes and equipment with a focus on environmental sustainability. By
integrating high-yield strains or cells, optimized culture processes, and advanced purification
technologies, we achieve scalable manufacturing capabilities with a green manufacturing
edge.
23

This platform tackles key technical challenges including, without limitation: (i) enhancing
recombinant protein expression and addressing protein degradation in fermentation through
synthetic biology and genetic engineering, thereby providing an upstream solution for
efficient recombinant protein production; (ii) employing diverse fermentation strategies to
overcome issues such as toxic byproduct accumulation, protein misfolding, and low activity
during rapid cell growth, enabling stable, high-efficiency expression of target proteins
using high-density synthetic biology techniques; (iii) combining different chromatographic
separation techniques and utilizing customized resins to develop scalable, cost-effective
processes for high-purity recombinant protein preparation; and (iv) improving volumetric
productivity and developing resource-efficient, low-energy green manufacturing solutions to
meet the demands of commercial-scale recombinant protein production.
Beyond our proprietary platform technologies, we boast commercial-scale manufacturing
capabilities and rigorous quality control and assurance systems, which enable us to efficiently
scale up production to accommodate the escalating demands of our drug candidates upon
commercialization, while ensuring exceptional quality and cost-effectiveness.
BUSINESS PROSPECTS
During the first half of 2026, we steadily advanced our core strategy of leveraging synthetic
biology to engineer chassis cells and to develop and manufacture recombinant biologic medicines
that are difficult to express using conventional gene engineering, achieving a number of important
milestones across R&D innovation, clinical advancement and industrial deployment. During the
remainder of 2026, we will further deepen reform of our R&D operating mechanisms in synthetic
biology, sharpen our focus on the core advantages of recombinant biologics, and continue to
improve R&D efficiency, strengthen external strategic collaborations, enhance science-based
decision-making, and consolidate and expand our leadership across four strategic areas:
large-volume subcutaneous drug delivery, antibody-mediated autoimmune conditions, assisted
reproduction, and recombinant biologic products. We will remain market- and clinical-value
oriented, and, around areas of high unmet medical need, continue to develop innovative medicines
with clear differentiation and global potential. Anchored by our chassis cell construction platform
and integrated with our drug design platform and end-to-end biomanufacturing platform, we
will keep strengthening core technological capabilities and raising the probability of success in
innovative drug R&D. In parallel, we will actively broaden global collaborations to accelerate
the cultivation of new competitive advantages and fully unlock the global value of our product
pipeline.
Specifically, we plan to implement the following strategies: (i) Accelerate development of our
pipeline in core therapeutic areas to fully unlock clinical and commercial value; (ii) Enhance
commercial-scale manufacturing capabilities and quality management systems to advance steadily
toward commercialization; (iii) Expand our global footprint, deepen strategic partnerships, and
realize the global value of our product pipeline; and (iv) Attract, develop and retain high-caliber
talent, optimize our operating system, and strive to become a global leader in developing
recombinant biologics using synthetic biology.

24

Accelerate Development of the Pipeline in Core Therapeutic Areas to Unlock Clinical and
Commercial Value
In 2026, our primary goals are to continue progressing our diversified clinical portfolio, advance
the commercialization of KJ017 following its approval in March 2026 and drive market uptake
for SJ02. We will expedite development and registration of core assets and other clinical and
preclinical candidates across our four strategic areas, while also implementing commercialization
initiatives for KJ017 and SJ02 to maximize patient access and sustained value. Specifically:
•

Large-volume subcutaneous drug delivery: We focus on recombinant human hyaluronidase
as the anchor of our SC delivery franchise. In March 2026, the 385U/vial dosage strength of
our Core Product KJ017 was approved for marketing by the NMPA for use as an adjuvant
to subcutaneous infusion, including Sodium Chloride Injection and Sodium Lactate Ringer’s
Injection, and we will continue to advance its commercialization in China. In tandem, we are
advancing the “Two-Anti” strategy to develop SC formulations for both antibody drugs and
chemical drugs. Our in-house innovative HER2-targeted bispecific antibody SC formulation,
KJ015, is expected to complete the Phase I clinical trial in China in the second half of 2026.
In August 2026, we obtained the IND approval for KJ015 from the FDA to commence
clinical trials. In addition to deepening collaborations with antibody developers to move more
SC antibody programs into late-stage clinical development, we will accelerate the clinical
development of SC antibiotics. BJ007 completed the Phase I clinical trial in China in January
2026 and is expected to enter a pivotal clinical trial in the second half of 2026. In May 2026,
the IND application for BJ007 was approved by the FDA, permitting the commencement of
clinical trials. We expect to commence the clinical trial for BJ007 overseas in the second half
of 2026.

•

Antibody-mediated autoimmune conditions: To address unmet needs across multiple
antibody-mediated autoimmune conditions, we will vigorously advance the development
of our Core Product KJ103. Our NDA for KJ103 for desensitization therapy in highly
sensitized kidney transplant patients was included in the priority review and approval
procedure in May 2026 and accepted by the NMPA in June 2026. We expect to receive
the NDA approval in 2027. In the second half of 2026, we expect to initiate the Phase III
clinical trial of KJ103 for anti-GBM disease and complete patient enrollment in the Phase
II clinical trial for GBS. In parallel, we will move combination therapy with recombinant
antibodies resistant to enzymatic degradation (such as BJ045 and BJ047) into the clinic and
actively explore KJ103’s potential in emerging fields such as xenotransplantation. Against
the backdrop of increasing organ failure and persistent organ shortage, xenotransplantation
has achieved notable technical progress globally. Our investigational products are designed
to help overcome immune rejection – one of the key determinants of success in this field.
Leveraging our expertise in enzyme technology and antibody engineering, we are confident
in capturing a meaningful share of this rapidly growing market, advancing the science of
xenotransplantation and addressing substantial unmet medical needs.

•

Assisted reproduction: To solve the treatment burden of daily injections with short-acting
FSH in women undergoing ART, we obtained marketing approval in August 2025 in China
for SJ02 (Slonva® (晟諾娃 ®)), a long-acting FSH-CTP that requires only a single injection,
effectively replacing up to seven daily doses of short-acting FSH and meaningfully improving
the current care paradigm. Going forward, we will work closely with our partner ANKE BIO
to fully execute the commercialization of SJ02 (Slonva® (晟諾娃 ®)) in China and realize its
clinical value.

25

•

Recombinant biologic products: Using synthetic biology, we are developing innovative
recombinant biologics by engineering high-efficiency chassis cells to produce complex
proteins that are difficult to manufacture via traditional biochemical extraction, thereby
addressing inefficiency, impurities, and safety risks (including allergies and unknown
viral contamination). Following completion of the Phase II clinical trial in June 2026, we
will continue to advance the clinical development of KJ101 for wound-healing indications
including burns, trauma, surgical incisions, pressure ulcers and diabetic foot ulcers. For the
indication of dissolution and removal of gastric mucus during gastroscopy, KJ101 received
clinical trial approval from the NMPA in March 2026, and we expect to complete the Phase
I clinical trial in the second half of 2026. In June 2026, the IND application for BJ044 was
approved by the NMPA and we expect to commence the Phase I clinical trial in the second
half of 2026.

Enhance Commercial-Scale Manufacturing Capabilities and Quality Management to Advance
Steadily Toward Commercialization
We have built GMP-compliant manufacturing facilities in Shanghai, covering a site area of
approximately 63,000 sq.m. To further upgrade commercial-scale capacity, we are constructing a
new site of approximately 37,000 sq.m. in Shanghai, which is expected to be completed and put
into operation in 2026. Our existing site is equipped with production lines specifically designed for
complex biological products and has specialized capabilities in recombinant protein manufacturing
to meet the production needs of our Core Products SJ02, KJ017 and KJ103, while supporting the
development of innovative assets under the “synthetic-biology upgrading to replace biochemical
extraction” strategy, including recombinant human chymotrypsin KJ101 (Phase II) and recombinant
ulinastatin BJ044 (IND-approved). These efforts respond to Shanghai’s initiative to transform
science-and-technology innovation strengths into high-quality manufacturing outputs. They are also
aligned with Baoshan North Shanghai Biopharmaceutical Industrial Park’s strategic positioning for
“synthetic biology industrialization” and the broader policy direction of promoting “high-quality
development of advanced biopharmaceutical manufacturing.”
With SJ02 approved in August 2025 and KJ017 approved in March 2026, our manufacturing focus
is transitioning from solely clinical supply to a dual track of clinical and commercial production.
We will continue to enhance site operational efficiency, benchmark against international standards,
and further enhance our integrated quality management system to ensure that product quality,
safety and efficacy consistently meet regulatory requirements and safeguard patient use.
Expand Global Footprint, Deepen Strategic Partnerships, and Fully Realize the Global Value
of the Pipeline
Building on the successful track record of our existing licenses and collaborations (including,
among others, WuXi Biologics, Shanghai RAAS, ANKE BIO, Qyuns, Sumgen), we will
continue to actively pursue new partnership opportunities worldwide. Our strategy includes:
(i) prioritizing product development and commercialization in the China market to establish
first-mover advantages; (ii) generating stable revenues through domestic product sales and
diversified collaborations to support sustained R&D and commercialization investment; and (iii)
following commercialization success in China, further expanding indications and advancing into
major overseas markets. For early-stage assets and platform technologies, we will also seek joint
development or in-/out-licensing collaborations with leading global biotechnology companies
and research institutions to explore new therapeutic areas and cutting-edge modalities, and
to strengthen platform capabilities. Through flexible partnership models, we aim to bring our
innovations to more patients globally and maximize the value of our product pipeline.
26

Attract, Develop and Retain High-Caliber Talent, and Optimize the Operating System
We will continue to execute a comprehensive talent strategy, proactively recruiting top
professionals with deep expertise and extensive experience in R&D, commercialization,
management, and global business development to support our rapid growth and internationalization.
In parallel, we will keep optimizing internal management processes – particularly enhancing
efficiency in R&D program management and cross-functional collaboration – to ensure agile
responses to market dynamics and the efficient advancement of pipeline assets.
During the remainder of 2026, as our business expands and new products come to market, we
will continue to uphold the mission of responding to urgent patient needs, address areas of unmet
medical need, and consistently develop high-access, broadly beneficial medicines. We strive to
grow into a globally influential leader in synthetic biology and recombinant biologics.
Cautionary Statement under Rule 18A.08(3) of the Listing Rules: There is no assurance that
our Core Products and our other drug candidates will ultimately be successfully developed
and marketed.
AWARDS AND RECOGNITION
In April 2026, following recommendation by the Shanghai Federation of Trade Unions, the
Company received the National May 1 Labor Certificate (全國五一勞動獎狀) at a national
ceremony and was one of 25 enterprises in Shanghai to receive the award.
FINANCIAL REVIEW
Revenue
Six months ended June 30,
2026
2025
(Audited)
(Unaudited)
RMB ’000
RMB ’000
Sales of materials
Technical services
Licensing revenue

1,170
8,705
–

983
1,005
40,002

Total

9,875

41,990

Our revenue decreased by RMB32.1 million, or 76.5%, from RMB42.0 million for the six months
ended June 30, 2025 to RMB9.9 million for the six months ended June 30, 2026, primarily due
to the absence of RMB40.0 million in one-off licensing revenue recognized in the Corresponding
Period, partially offset by increases of RMB7.7 million in technical services revenue and RMB0.2
million in sales of materials.

27

Cost of Sales
During the Reporting Period, our cost of sales primarily included costs of raw materials, staff
costs, and certain depreciation and amortization expenses related thereto. Our cost of sales
increased from RMB0.3 million for the six months ended June 30, 2025 to RMB0.5 million for the
six months ended June 30, 2026.
Other Income and Gains
Six months ended June 30,
2026
2025
(Audited)
(Unaudited)
RMB ’000
RMB ’000
Other Income
Government grants*
Bank interest income
Others
Gains
Changes due to passive dilution of investment in an associate
Gain on disposal of right-of-use assets
Total
*

2,648
9,465
61

1,894
3,591
414

75
5

–
–

12,254

5,899

The government grants have been received from the PRC local government authorities for supporting the
Group’s research and development and other operating activities. There are no unfulfilled conditions relating to
these government grants. As at June 30, 2026, asset-related government grants received but not yet meeting the
conditions for revenue recognition amounted to RMB114.7 million.

Our other income and gains increased by RMB6.4 million, or 107.7%, from RMB5.9 million
for the six months ended June 30, 2025 to RMB12.3 million for the six months ended June 30,
2026, primarily due to an increase of RMB5.9 million in bank interest income and an increase of
RMB0.8 million in government grants.

28

Administrative Expenses
Six months ended June 30,
2026
2025
(Audited)
(Unaudited)
RMB ’000
RMB ’000
Staff costs
Depreciation and amortization expenses
Share-based payments
Taxes and surcharges
Professional service fees
General office expenses
Others

15,449
9,128
4,601
2,787
2,750
1,890
4,011

13,169
4,748
17,732
991
2,622
3,827
3,064

Total

40,616

46,153

Our administrative expenses decreased by RMB5.5 million, or 12.0%, from RMB46.2 million for
the six months ended June 30, 2025 to RMB40.6 million for the six months ended June 30, 2026,
primarily due to the decrease in share-based payments incurred from our grant of share incentives
to management and administrative personnel.
Research and Development Expenses
Six months ended June 30,
2026
2025
(Audited)
(Unaudited)
RMB ’000
RMB ’000
Trial and testing expenses
Staff costs
Depreciation and amortization expenses
Share-based payments
Costs of raw materials
Others

33,710
29,259
11,560
7,558
5,029
5,454

19,881
36,231
12,166
27,636
7,517
7,614

Total

92,570

111,045

Our research and development expenses decreased by RMB18.5 million, or 16.6%, from
RMB111.0 million for the six months ended June 30, 2025 to RMB92.6 million for the six months
ended June 30, 2026. This decrease was primarily attributable to a RMB20.1 million reduction in
share-based payment expenses associated with equity incentives granted to our R&D personnel,
partially offset by a RMB13.8 million increase in trial and testing expenses as we advanced the
ongoing clinical development of our drug candidates.

29

Other Expenses
Our other expenses decreased by RMB20.0 million, or 36.2%, from RMB55.4 million for the
six months ended June 30, 2025 to RMB35.3 million for the six months ended June 30, 2026,
primarily because no additional provision for losses on litigation was recognized during the
Reporting Period, partially offset by a net increase of RMB35.0 million in net foreign exchange
losses.
Share of Loss of an Associate
Our share of loss of an associate during the Reporting Period represented our losses from
investments in ABLINK Biotech. We recognized share of loss of an associate of RMB114,000 and
RMB54,000 for the six months ended June 30, 2025 and 2026, respectively, which was attributable
to the net losses incurred by ABLINK Biotech during the same periods.
Prepayments, Other Receivables and Other Assets
June 30,
2026
(Unaudited)
RMB ’000

December 31,
2025
(Audited)
RMB ’000

Non-current:
Prepayment for property, plant and equipment

26,624

97,062

Current:
Prepayments
Deposits and other receivables
Deductible value-added tax
Prepaid expenses

5,332
2,124
46,577
511

3,513
1,333
21,904
837

Total

54,544

27,587

30

Capital Structure, Liquidity and Financial Resources
As of June 30, 2026, the Group’s cash and cash equivalents amounted to RMB1,042.1 million, as
compared with RMB1,241.6 million as of December 31, 2025. As of June 30, 2026, the Group’s
cash and bank balances were primarily denominated in RMB, HKD and USD.
The decrease in the Group’s cash position was primarily attributable to net cash used in operating
activities of RMB146.6 million and net cash used in investing activities of RMB116.2 million,
partially offset by net cash generated from financing activities of RMB99.2 million.
As of June 30, 2026, the Group’s current assets were RMB1,212.2 million (as of December 31,
2025: RMB1,363.2 million), primarily consisting of cash and cash equivalents of RMB1,042.1
million, restricted deposits of RMB91.9 million, prepayments, other receivables and other assets of
RMB54.5 million, inventories of RMB16.8 million, and trade receivables of RMB6.9 million.
As of June 30, 2026, the Group’s current liabilities were RMB314.7 million (as of December
31, 2025: RMB330.7 million), primarily consisting of other payables and accruals of RMB175.6
million, interest-bearing bank borrowings of RMB134.1 million, deferred income of RMB3.6
million, lease liabilities of RMB1.1 million, and trade payables of RMB0.3 million.
As of June 30, 2026, the Group maintained a healthy liquidity position. The Group monitors and
maintains a level of cash and cash equivalents deemed adequate by management to finance its
operations and mitigate the effects of fluctuations in cash flows. During the Reporting Period, we
primarily funded our working capital requirements through existing cash and cash equivalents and
bank borrowings.
The Group expects to fund its working capital and other capital requirements from a combination
of various sources, including but not limited to external financing at reasonable market rates.
In order to better control and minimize the cost of funds, the Group’s treasury activities are
centralized and all cash transactions are conducted with reputable banks.
Gearing Ratio
The Group monitors capital using a gearing ratio, which is calculated as total debt divided by total
assets. Total debt includes current liabilities and non-current liabilities.
As of June 30, 2026, the Group’s gearing ratio was 33.23%, as compared with 28.19% as of
December 31, 2025.

31

Indebtedness
As of June 30, 2026, the Group had interest-bearing bank borrowings of RMB421.6 million, as
compared with RMB312.4 million as of December 31, 2025. Of such borrowings, RMB134.1
million were repayable within one year and RMB287.5 million were repayable beyond one year.
As of June 30, 2026, the Group’s lease liabilities amounted to RMB1.6 million, as compared with
RMB2.6 million as of December 31, 2025. The change was primarily due to lease payments made
during the Reporting Period.
Capital Commitments
As of June 30, 2026, the Group had capital commitments of RMB132.5 million (as of December
31, 2025: RMB174.5 million). Such capital commitments were primarily related to the acquisition
and construction of property, plant and equipment.
Contingent Liabilities
As of June 30, 2026, the Group did not have any contingent liabilities.
Pledge of Assets
As of June 30, 2026, certain of the Group ’ s bank borrowings were secured by the Group ’ s
property, plant and equipment with carrying amounts of approximately RMB562.4 million
(as of December 31, 2025: RMB539.8 million) and leasehold land with carrying amounts of
approximately RMB50.2 million (as of December 31, 2025: RMB50.8 million).
Foreign Exchange Exposure
The Group has transactional currency exposures arising primarily from cash and cash equivalents
denominated in currencies other than the functional currency of the Company, mainly HKD and
USD.
The Group currently does not use any financial instruments or enter into any foreign exchange
contracts to hedge against foreign exchange risk. However, management monitors foreign exchange
exposure closely and will consider hedging significant foreign currency exposure should the need
arise.
EMPLOYEES AND REMUNERATION POLICY
As of June 30, 2026, the Group had a total of 364 full-time employees. Our employees receive
compensation comprising base salaries, discretionary bonuses and benefits, which are generally
determined with reference to their qualifications, industry experience, positions and performance.
We make contributions to social insurance and the housing provident fund in accordance with PRC
laws and regulations. In addition, we provide relevant training to enhance our employees’ skills
and knowledge. We have also implemented employee incentive plans to recognize and reward
employee contributions.

32

SIGNIFICANT INVESTMENTS, ACQUISITIONS AND DISPOSALS
During the Reporting Period, the Group did not have any significant investments or material
acquisitions or disposals of subsidiaries, associates and joint ventures.
The Group did not have any future plans for material investments or capital assets as of the date of
this announcement. The Company will make further announcements in accordance with the Listing
Rules, where applicable, if any investments and acquisition opportunities materialize.
SUBSEQUENT EVENTS AFTER THE REPORTING PERIOD
As of the date of this announcement, there were no material subsequent events after the Reporting
Period other than those disclosed in this announcement.
INTERIM DIVIDEND
The Board has resolved not to recommend an interim dividend for the six months ended June 30,
2026 (six months ended June 30, 2025: nil).
CORPORATE GOVERNANCE AND OTHER INFORMATION
Compliance with the Corporate Governance Code
The Company is committed to achieving high standards of corporate governance with a view to
safeguarding the interests of the Shareholders and to enhancing corporate value and accountability.
The Company has adopted the CG Code set out in Appendix C1 to the Listing Rules as its own
code of corporate governance. During the Reporting Period, the Board is of the view that the
Company has complied with all applicable code provisions set out in Part 2 of the CG Code. In
order to maintain a high standard of corporate governance, the Board will continue to review and
monitor the operation of the Company.
At the annual general meeting held on May 26, 2026, the Shareholders approved, among other
things, the abolition of the Supervisory Committee and the election of the second session of the
Board. Following the abolition of the Supervisory Committee, the Audit Committee assumed the
functions and powers formerly exercised by the Supervisory Committee in accordance with the
amended Articles of Association.
Compliance with the Model Code
The Company has adopted a code of conduct regarding the Directors’, former Supervisors’ and
employees’ securities transactions on terms no less exacting than the required standards set out in
the Model Code.
Having made specific enquiries with all Directors and former Supervisors, each of them has
confirmed that he/she has complied with our Company’s code of conduct regarding the Directors’,
former Supervisors’ and employees’ securities transactions during his/her respective term of office
within the six months ended June 30, 2026. No incident of non-compliance of the Model Code by
the employees who are likely to be in possession of inside information of the Company was noted
by the Company during the six months ended June 30, 2026.

33

CHANGE OF INFORMATION OF DIRECTORS AND CHIEF EXECUTIVES
The following sets out the changes in the particulars of Directors and chief executives of the
Company which are required to be disclosed pursuant to Rule 13.51B(1) of the Listing Rules:
(1)

Mr. Zhang Senquan (張森泉), an independent non-executive Director, has been appointed as
the company secretary and the authorised representative of Yunhong Guixin Group Holdings
Limited (運鴻硅鑫集團控股有限公司) (HKSE: 8349), with effect from March 9, 2026;

(2)

At the annual general meeting of the Company held on May 26, 2026, the remuneration
standard for the independent non-executive Directors of the second session of the Board of
Directors was approved at RMB240,000 per annum (pre-tax) (compared to RMB150,000 per
annum (pre-tax) prior to the re-election), payable in equal quarterly instalments.

Save as disclosed above, there has been no other change in the information of the Directors and
chief executives of the Company which is required to be disclosed pursuant to Rule 13.51B(1) of
the Listing Rules as of the date of this announcement.
CHANGE OF JOINT COMPANY SECRETARY, AUTHORISED REPRESENTATIVE AND
PROCESS AGENT
Ms. Fong Christine Haiman (方希琳) ( “ Ms. Fong ” ) has tendered her resignation as (i) the
joint company secretary of the Company (the “Joint Company Secretary”); (ii) an authorised
representative of the Company (the “Authorised Representative”) for the purpose of Rule 3.05
of the Listing Rules on the Stock Exchange; and (iii) the representative for acceptance of service
of process and notices on behalf of the Company in Hong Kong as required under Rule 19.05(2)
of the Listing Rules and Part 16 of the Companies Ordinance (Chapter 622 of the Laws of Hong
Kong) (the “Process Agent”) with effect from July 8, 2026. Following the resignation of Ms. Fong,
Mr. Tsang Chun Ho (曾俊豪) (“Mr. Tsang”) has been appointed as the Joint Company Secretary,
the Authorised Representative and the Process Agent with effect from July 8, 2026. Following the
appointment of Mr. Tsang, the Joint Company Secretaries of the Company are Ms. Li Cui (李翠)
and Mr. Tsang, and the Authorised Representatives of the Company are Dr. Liu Yanjun (劉彥君)
and Mr. Tsang. For further details, please refer to the announcement of the Company dated July 8,
2026.

34

PURCHASE, SALE OR REDEMPTION OF THE LISTED SECURITIES OF THE
COMPANY
During the Reporting Period, the Company repurchased a total of 95,200 H Shares on the Stock
Exchange at an aggregate consideration of approximately HK$1.7 million (before transaction
costs). All such repurchased H Shares were held as treasury shares. Save as disclosed above,
neither the Company nor any of its subsidiaries purchased, sold or redeemed any of the Company’s
listed securities (including any sale of treasury shares) during the Reporting Period. As of June 30,
2026, the Company held 95,200 treasury shares.
Details of the repurchase are set out below:
Month of repurchase during
the Reporting Period

No. of Shares
repurchased

June 2026

95,200

Total

95,200

Price paid per Share
Highest price
Lowest price
(HK$)
(HK$)
17.81

17.38

Aggregate
consideration
paid
(HK$)
1,686,277.6
1,686,277.6

USE OF PROCEEDS
With the shares of the Company listed on the Stock Exchange on December 10, 2025, the
net proceeds from the Global Offering were approximately HK$921.5 million after deducting
underwriting fees and commissions and estimated expenses payable by us in connection with the
Global Offering, which have been and will be utilized for the purposes as set out in the Prospectus.
As of the date of this announcement, there was no change in the intended use of net proceeds
as previously disclosed in the section headed “ Future Plans and Use of Proceeds ” in the
Prospectus. To the extent that the net proceeds of the Global Offering are not immediately used
for the purposes described above, we will only deposit the unused net proceeds into short-term
interest-bearing accounts at licensed commercial banks and/or other authorized financial
institutions (as defined under the SFO or applicable laws and regulations in other jurisdictions).
The table below sets out the planned applications of the net proceeds, the unutilized amounts as
of December 31, 2025, the utilized amounts during the Reporting Period, the utilized amounts as
at June 30, 2026 and the unutilized amounts as of June 30, 2026. Any discrepancies in this table
between the total and sums of amounts are due to rounding.

35

Intended use of net proceeds

Allocation
of net
proceeds
HKD in million

Net proceeds
Net proceeds
utilized Net proceeds Net proceeds
Percentage unutilized as at
during the
utilized
unutilized
of total net December 31,
Reporting as at June 30, as at June 30,
proceeds
2025
Period
2026
2026
HKD in million HKD in million HKD in million HKD in million

Research and development and commercialization of our
Core Products, including KJ017, KJ103 and SJ02

493.2

53.5%

489.8

42.0

45.4

447.8

Advancement of other existing pipeline assets and
preparation for any related registration filings

162.8

17.7%

155.7

15.4

22.5

140.3

Continued optimization of the Group’s proprietary synthetic
biology technology platforms, as well as exploration and
development of new drug candidates

77.4

8.4%

75.3

30.5

32.6

44.8

Enhancing and scaling up our manufacturing capabilities

95.9

10.4%

69.0

44.7

71.6

24.3

Working capital and general corporate
purposes

92.2

10.0%

90.0

9.3

11.5

80.7

Total

921.5

100.0%

879.8

141.9

183.6

737.9

The unutilized amount of net proceeds from the Global Offering is expected to be fully utilized by
December 31, 2028.

36

AUDIT COMMITTEE
The Company has established an Audit Committee with written terms of reference that comply
with Rule 3.21 of the Listing Rules and the CG Code and are published on the website of the Hong
Kong Stock Exchange. The primary duties of the Audit Committee are to review and supervise
the financial reporting process and internal control system of the Group and provide advice and
comments to the Board. As of the date of this announcement, the Audit Committee comprises two
independent non-executive Directors and one non-executive Director, namely, Mr. Zhang Senquan
(張森泉) (“Mr. Zhang”), Dr. Ju Dianwen (鞠佃文) and Mr. Diao Juanhuan (刁雋桓), with Mr.
Zhang serving as the chairman. Mr. Zhang has the appropriate professional experience as required
under Rules 3.10(2) and 3.21 of the Listing Rules.
The Audit Committee has reviewed, together with the management of the Company, the accounting
principles and policies adopted by the Group and discussed internal controls and financial reporting
matters, including a review of the unaudited condensed consolidated interim financial information
and interim results of the Group for the six months ended June 30, 2026.
The Group’s unaudited interim condensed consolidated financial information for the six months
ended June 30, 2026 has been reviewed by Ernst & Young 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.
APPRECIATION
On behalf of the Board, I wish to express my sincere gratitude to our Shareholders and business
partners for their continued trust and support, and to our employees for their diligence, dedication,
loyalty and integrity.

37

INTERIM CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS
for the six months ended June 30, 2026
(Unaudited and expressed in RMB)

Notes

Six months ended June 30,
2026
2025
(Audited)
(Unaudited)
RMB ’000
RMB ’000
9,875

41,990

Cost of sales

(537)

(265)

Gross profit

9,338

41,725

12,254
(92,570)
(3,610)
(40,616)
–
(3,088)
(35,339)
(54)

5,899
(111,045)
(2,942)
(46,153)
(12,435)
(2,666)
(55,365)
(114)

(153,685)

(183,096)

–

–

LOSS FOR THE PERIOD

(153,685)

(183,096)

Attributable to:
Owners of the parent

(153,685)

(183,096)

(0.47)

(0.64)

4

Revenue

4

Other income and gains
Research and development expenses
Business development expenses
Administrative expenses
Listing expenses
Finance costs
Other expenses
Share of loss of an associate
LOSS BEFORE TAX

5

Income tax credit

LOSS PER SHARE ATTRIBUTABLE TO ORDINARY
EQUITY HOLDERS OF THE PARENT
Basic and diluted (RMB)

38

7

INTERIM CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE
INCOME
for the six months ended June 30, 2026
(Unaudited and expressed in RMB)
Six months ended June 30,
2026
2025
(Audited)
(Unaudited)
RMB ’000
RMB ’000
(153,685)

(183,096)

Other comprehensive loss that may be reclassified to
profit or loss in subsequent periods:
Exchange differences on translation of foreign operations

(542)

–

OTHER COMPREHENSIVE LOSS FOR THE PERIOD,
NET OF TAX

(542)

–

TOTAL COMPREHENSIVE LOSS FOR THE PERIOD

(154,227)

(183,096)

Attributable to:
Owners of the parent

(154,227)

(183,096)

LOSS FOR THE PERIOD
OTHER COMPREHENSIVE LOSS

39

INTERIM CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
as at June 30, 2026
(Expressed in RMB)
June 30,
2026
(Unaudited)
RMB ’000

December 31,
2025
(Audited)
RMB ’000

857,276
51,906
10,951
10,835
26,624

680,696
53,561
11,690
10,814
97,062

957,592

853,823

16,780
6,906
54,544
91,917
1,042,096

6,248
98
27,587
87,614
1,241,609

1,212,243

1,363,156

304
175,637
134,083
3,621
1,079

8
210,492
113,958
4,587
1,607

Total current liabilities

314,724

330,652

NET CURRENT ASSETS

897,519

1,032,504

1,855,111

1,886,327

NON-CURRENT LIABILITIES
Interest-bearing bank borrowings
Lease liabilities
Deferred income

287,481
524
118,382

198,451
979
94,923

Total non-current liabilities

406,387

294,353

Net assets

1,448,724

1,591,974

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

65,196
(1,468)
1,384,996

65,196
–
1,526,778

Total equity

1,448,724

1,591,974

Notes

NON-CURRENT ASSETS
Property, plant and equipment
Right-of-use assets
Other intangible assets
Investment in an associate
Prepayments, other receivables and other assets

8

Total non-current assets
CURRENT ASSETS
Inventories
Trade receivables
Prepayments, other receivables and other assets
Restricted deposits
Cash and cash equivalents

9
8

Total current assets
CURRENT LIABILITIES
Trade payables
Other payables and accruals
Interest-bearing bank borrowings
Deferred income
Lease liabilities

10
11

TOTAL ASSETS LESS CURRENT LIABILITIES

40

INTERIM CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
for the six months ended June 30, 2026
(Unaudited and expressed in RMB)

Notes

CASH FLOWS USED IN OPERATING ACTIVITIES
Loss before tax
Adjustments for:
Interest income
Finance costs
Equity-settled share-based payment expense
Foreign exchange differences, net
Depreciation of property, plant and equipment
Depreciation of right-of-use assets
Amortisation of other intangible assets
Changes due to passive dilution of
investment in an associate
Gain on disposal of right-of-use assets
Loss on disposal of items of property, plant and
equipment
Share of loss of an associate

Six months ended June 30,
2026
2025
(Audited)
(Unaudited)
RMB ’000
RMB ’000
(153,685)

(183,096)

4

(9,465)
3,088
12,445
35,329
17,518
1,441
1,251

(3,591)
2,666
46,805
282
15,099
851
1,044

4
4

(75)
(5)

–
–

–
54

3
114

(92,104)

(119,823)

(Increase)/decrease in trade receivables
Increase in prepayments, other receivables and other assets
Increase in inventories
(Decrease)/increase in deferred income
Increase in trade payables
(Decrease)/increase in other payables and accruals
Decrease/(increase) in restricted deposits

(6,808)
(26,957)
(7,714)
(940)
296
(21,925)
65

22
(7,093)
(647)
200
–
18,644
(84)

Cash used in operations
Interest received

(156,087)
9,465

(108,781)
3,591

Net cash flows used in operating activities

(146,622)

(105,190)

(135,245)
(4,368)

(37,891)
5,000

4

371

23,433

2,700

(116,176)

(29,820)

CASH FLOWS USED IN INVESTING ACTIVITIES
Purchases of items of property, plant and equipment
(Placement)/withdrawal of restricted deposits
Proceeds from disposal of items of property, plant and
equipment
Receipt of government grants for property, plant and
equipment
Net cash flows used in investing activities
41

INTERIM CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
for the six months ended June 30, 2026
(Unaudited and expressed in RMB)

Notes

Six months ended June 30,
2026
2025
(Audited)
(Unaudited)
RMB ’000
RMB ’000

CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from issue of shares
New interest-bearing bank borrowings
Repayment of interest-bearing bank borrowings
Principal portion of lease payment
Interest paid
Repurchase of ordinary shares
Payment for listing expenses

–
163,382
(54,268)
(764)
(4,986)
(1,468)
(2,740)

30,000
87,291
(45,750)
(836)
(3,582)
–
(2,597)

Net cash flows generated from financing activities

99,156

64,526

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

(163,642)
1,241,609
(35,871)

(70,484)
524,158
(282)

CASH AND CASH EQUIVALENTS AT END OF
PERIOD

1,042,096

453,392

42

NOTES TO THE INTERIM CONDENSED CONSOLIDATED FINANCIAL INFORMATION
1.

CORPORATE AND GROUP INFORMATION
The Company was established in the People’s Republic of China (the “PRC”) on 16 December 2019, as a
limited liability company under the Companies Law of the PRC. The registered office of the Company is located
at No. 28 Luoxin Road, Baoshan District, Shanghai. The Company was converted into a joint stock company on
26 July 2023.
During the period, the Company and its subsidiaries were involved in the research, development and
commercialisation of pharmaceutical products.
The shares of the Company have been listed on the Main Board of the Stock Exchange of Hong Kong Limited
(the “Stock Exchange”) effective from 10 December 2025.

2.1

BASIS OF PREPARATION
The interim condensed consolidated financial information for the six months ended 30 June 2026 has been
prepared in accordance with IAS 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.

2.2

CHANGES IN ACCOUNTING POLICIES AND DISCLOSURES
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 IFRS Accounting
Standards for the first time for the current period’s financial information.

Amendments to the Classification and Measurement of Financial
Instruments
Amendments to IFRS 9 and IFRS 7
Contracts Referencing Nature-dependent Electricity
Annual Improvements to IFRS Accounting Amendments to IFRS 1, IFRS 7, IFRS 9, IFRS 10 and IAS 7
Standards – Volume 11
Amendments to IFRS 9 and IFRS 7

3.

OPERATING SEGMENT INFORMATION
Operating segment information
For management purposes, the Group has only one reportable operating segment, which is the research,
development and commercialisation of pharmaceutical products. Since this is the only reportable operating
segment of the Group, no further operating segment analysis thereof is presented.
Geographical information
During the reporting period, nearly all of the Group’s revenue was derived from customers located in the
Chinese mainland and all of the Group’s non-current assets were located in the Chinese mainland, and therefore
no geographical segment information is presented in accordance with IFRS 8 Operating Segments .

43

4.

REVENUE, OTHER INCOME AND GAINS
An analysis of revenue is as follows:
Six months
ended
June 30, 2026
(Unaudited)
RMB ’000

Six months
ended
June 30, 2025
(Audited)
RMB ’000

9,875

41,990

Six months
ended
June 30, 2026
(Unaudited)
RMB ’000

Six months
ended
June 30, 2025
(Audited)
RMB ’000

Types of goods and services
Sales of materials
Technical services
Licensing revenue

1,170
8,705
–

983
1,005
40,002

Total

9,875

41,990

Timing of revenue recognition
Goods transferred at a point in time
Services transferred at a point in time

1,170
8,705

983
41,007

Total

9,875

41,990

Revenue from contracts with customers

Disaggregated revenue information

The following table shows the amounts of revenue recognised in each reporting period that were included in
the contract liabilities at the beginning of each reporting period and recognised from performance obligations
satisfied in previous periods:

Revenue from contracts with customers

44

Six months
ended
June 30, 2026
(Unaudited)
RMB ’000

Six months
ended
June 30, 2025
(Audited)
RMB ’000

–

40,011

An analysis of other income and gains is as follows:
Six months
ended
June 30, 2026
(Unaudited)
RMB ’000

Six months
ended
June 30, 2025
(Audited)
RMB ’000

Other income
Government grants*
Bank interest income
Others

2,648
9,465
61

1,894
3,591
414

Total other income

12,174

5,899

Gains
Changes due to passive dilution of investment in an associate
Gain on disposal of right-of-use assets

75
5

–
–

Total gains

80

–

12,254

5,899

Total other income and gains
*

The government grants have been received from the PRC local government authorities for supporting the
Group’s operating activities. There are no unfulfilled conditions relating to these government grants.

45

5.

INCOME TAX
Chinese mainland
Pursuant to the Corporate Income Tax Law of the People’s Republic of China and the respective regulations,
Hainan Baoji Biotechnology Co., Ltd. was subject to corporate income tax at a rate of 25% on taxable income
during the Reporting Period. Shanghai Bao Pharmaceuticals Co., Ltd., Suzhou Centergene Pharmaceuticals Co.,
Ltd. and Suzhou Kangju Biotechnology Co., Ltd. were entitled to a preferential corporate income tax rate of
15% from 2025 to 2027 as qualified High and New Technology Enterprises.
Hong Kong
The subsidiary incorporated in Hong Kong and the subsidiary registered as a Hong Kong tax resident were
subject to income tax at a rate of 16.5% on estimated assessable profits arising in Hong Kong during the
Reporting Period. The first HKD2,000,000 of assessable profits of the subsidiary are taxed at 8.25% and the
remaining assessable profits are taxed at 16.5%.
No provision for income taxation has been made for the six months ended June 30, 2026 (six months ended June
30, 2025: nil), as the Group had no assessable profits derived from the operating entities of the Group.

6.

DIVIDENDS
No dividend was paid or declared by the Company during the six months ended June 30, 2026 (six months
ended June 30, 2025: nil).

7.

LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY HOLDERS OF THE PARENT
The calculation of the basic loss per share amounts 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 325,981,465 (six months
ended June 30, 2025: 288,040,355) outstanding during the period.
The calculation of the diluted loss per share amounts is based on the loss for the period attributable to ordinary
equity holders of the parent, and 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 loss per share calculation, and the
weighted average number of ordinary shares assumed to have been issued at no consideration on the deemed
exercise or conversion of all dilutive potential ordinary shares into ordinary shares.

46

The calculations of basic and diluted loss per share are based on:

Loss
Loss attributable to ordinary equity holders of the parent

Shares
Weighted average number of ordinary shares outstanding during
the period used in the basic loss per share calculation*
*

Six months
ended
June 30, 2026
(Unaudited)
RMB ’000

Six months
ended
June 30, 2025
(Audited)
RMB ’000

(153,685)

(183,096)

Six months
ended
June 30, 2026
(Unaudited)

Six months
ended
June 30, 2025
(Audited)

325,981,465

288,040,355

The weighted average number of shares was after taking into account the effect of treasury shares held.
The loss per share attributable to ordinary equity holders of the parent for the six months ended June
30, 2025 has been restated to reflect the impacts of the share subdivision of the Company effective from
December 10, 2025 (“Share Subdivision”).

47

8.

9.

PREPAYMENTS, OTHER RECEIVABLES AND OTHER ASSETS
June 30,
2026
(Unaudited)
RMB ’000

December 31,
2025
(Audited)
RMB ’000

Non-current:
Prepayment for property, plant and equipment

26,624

97,062

Current:
Prepayments
Deposits and other receivables
Deductible value-added tax
Prepaid expenses

5,332
2,124
46,577
511

3,513
1,333
21,904
837

Total

54,544

27,587

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

Within 1 year
10.

June 30,
2026
(Unaudited)
RMB ’000

December 31,
2025
(Audited)
RMB ’000

6,906

98

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 3 months

June 30,
2026
(Unaudited)
RMB ’000

December 31,
2025
(Audited)
RMB ’000

304

8

The trade payables are non-interest-bearing and are normally settled on terms of three months.

48

11.

OTHER PAYABLES AND ACCRUALS

Notes

Payroll payables
Contract liabilities
Payables for purchase of property, plant and equipment
Other payables
Amounts due to related parties
Provision for losses on litigation
Accrual for property, plant and equipment
Tax payables
Accrued listing expenses
Total

(a)
(b)

June 30,
2026
(Unaudited)
RMB ’000

December 31,
2025
(Audited)
RMB ’000

12,436
6,549
48,029
40,467
70
55,080
10,239
2,064
703

18,331
1,818
26,430
50,797
127
55,080
42,028
3,471
12,410

175,637

210,492

Notes:
(a)

As at 30 June 2026, the Group was involved in litigation associated with a technology transfer agreement
with a biotechnology company.
Pursuant to the first instance judgement in May 2025 issued by the PRC District Court, the Group was
ordered to (i) make payment amounting to approximately RMB55,080,000 which had been recognised
in “Provision for losses on litigation” under “Other expenses” in the consolidated statement of profit or
loss for the six months ended June 30, 2025; and (ii) return the aforesaid balance of advances from the
plaintiff, of which RMB18,360,000 was recognised in “Other payables” at 31 December 2025.
In July 2026, the PRC High Court issued an order revoking the aforementioned rulings and remanding the
case to the First Instance Court for retrial. As at 30 June 2026, the Group retained fully provided for the
litigation exposure.

(b)

As at 31 December 2025, the Group was involved in litigation associated with a pharmaceutical enterprise
regarding a construction project.
Pursuant to the first and second instance judgements in August 2025 and March 2026 issued by the PRC
District Court, the Group was held jointly and severally liable to pay the outstanding construction fees
along with applicable interest which had been recognised in “Accrual for property, plant and equipment”
under “Other payables” at 31 December 2025 amounting to approximately RMB31,789,000.
In June 2026, the construction fees and interest were enforced against the other defendant in the litigation
by the PRC District Court and accordingly, the Group was no longer liable for the payment on the
litigation and the corresponding liability was fully reversed.

49

PUBLICATION OF THE INTERIM RESULTS ANNOUNCEMENT AND THE INTERIM
REPORT ON THE WEBSITES OF THE STOCK EXCHANGE AND THE COMPANY
This interim results announcement is published on the Company’s website (www.baopharma.com)
and the website of the Hong Kong Stock Exchange (www.hkexnews.hk). The 2026 interim report
of the Company containing all relevant information required under the Listing Rules will be
dispatched to the Shareholders (if requested) and published on the afore-mentioned websites in due
course.
DEFINITIONS
In this announcement, unless the context otherwise requires, the following terms have the
following meanings. These terms and their definitions may not correspond to any industry standard
definition and may not be directly comparable to similarly titled terms adopted by other companies
operating in the same industries as the Company.
“ABLINK Biotech”

ABLINK Biotechnology Co., Ltd. (成都盛世君聯生物技術有限
公司), a limited liability company established under the laws of
the PRC on March 10, 2016, which is owned by the Company as
to approximately 16.92%

“Articles of Association” or
“Articles”

the articles of association of our Company adopted by special
resolution on January 21, 2025 with effect from the Listing Date,
as amended, supplemented or otherwise modified from time to
time

“Audit Committee”

the audit committee of our Board

“Board”

the board of directors of the Company

“CDE”

the Center for Drug Evaluation of the NMPA

“CG Code”

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

“China” or the “PRC”

the People ’ s Republic of China, but for the purpose of this
announcement and for geographical reference only, references
herein to “China” and the “PRC” do not apply to Hong Kong, the
Macau Special Administrative Region of the PRC and Taiwan

“Companies Ordinance”

the Companies Ordinance (Chapter 622 of the Laws of Hong
Kong), as amended, supplemented or otherwise modified from
time to time

“Core Product”

has the meaning ascribed thereto in Chapter 18A of the Listing
Rules and refers to the product for the purpose of satisfying the
eligibility requirements under Chapter 18A of the Listing Rules
and Chapter 2.3 of the Guide for New Listing Applicants; for the
purpose of this announcement, our Core Products refer to KJ017,
KJ103, and SJ02

50

“Company,” “our Company,”
or “the Company”

Shanghai Bao Pharmaceuticals Co., Ltd. (上海寶濟藥業股份有限
公司), a joint stock company incorporated in the PRC with limited
liability on July 26, 2023, or, where the context requires (as the
case may be), its predecessor, Shanghai Bao Pharmaceuticals
Co., Ltd. (上海寶濟藥業有限公司), a limited liability company
established under the laws of the PRC on December 16, 2019

“Corresponding Period”

the six months ended June 30, 2025

“CSO”

contract sales organization, a company that provides outsourced
sales and marketing services to another company on a contractual
basis

“Director(s)”

the director(s) of our Company

“DIVA”

difficult venous access, a condition where it is challenging to
locate or access veins for medical procedures like blood draws or
intravenous cannulation insertion

“DMF”

drug master files, submissions to FDA used to provide
confidential, detailed information about facilities, processes, or
articles used in the manufacturing, processing, packaging, and
storing of human drug products

“FDA”

Food and Drug Administration

“GCP”

Good Clinical Practice

“Global Offering”

the Hong Kong Public Offering and the International Offering
(each as defined in the Prospectus)

“GMP”

Good Manufacturing Practice

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

the Company and its subsidiary from time to time

“H Share(s)”

ordinary share(s) in the share capital of our Company, with a
nominal value of RMB0.20 each, which are subscribed for and
traded in Hong Kong dollars and listed on the Stock Exchange

“HK$” or “HKD”

Hong Kong dollars, the lawful currency of Hong Kong

“Hong Kong” or “HK”

the Hong Kong Special Administrative Region of the PRC

“Hong Kong Stock Exchange”
or “Stock Exchange”

The Stock Exchange of Hong Kong Limited

“IND”

Investigational New Drug

“Listing”

the listing of the H Shares on the Main Board of the Stock
Exchange
51

“Listing Date”

December 10, 2025

“Listing Rules”

the Rules Governing the Listing of Securities on the Stock
Exchange, as amended from time to time

“Model Code”

the 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 the PRC (國
家藥品監督管理局), successor to the China Food and Drug
Administration or CFDA (國家食品藥品監督管理總局)

“Prospectus”

the prospectus of our Company dated December 2, 2025 being
issued in connection with the Listing

“R&D”

research and development

“Reporting Period”

the six months ended June 30, 2026

“RMB” or “Renminbi”

the lawful currency of the PRC

“SFO”

the Securities and Futures Ordinance (Chapter 571 of the Laws
of Hong Kong), as amended, supplemented or otherwise modified
from time to time

“Share(s)”

ordinary share(s) in the share capital of our Company with a
nominal value of RMB0.20 each, comprising Unlisted Share(s)
and H Share(s)

“Shareholder(s)”

shareholder(s) of the Company

“treasury shares”

has the meaning as defined under the Listing Rules

“U.S.” or “United States”

the United States of America, its territories and possessions, any
State of the United States, and the District of Columbia

“U.S. dollar” or “US$”

United States dollar, the lawful currency of the United States

“%”

per cent
By order of the Board
Shanghai Bao Pharmaceuticals Co., Ltd.
上海寶濟藥業股份有限公司
Dr. LIU YANJUN
Chairman of the Board and Executive Director

Shanghai, PRC, August 28, 2026

As at the date of this announcement, the Board comprises: (i) Dr. Liu Yanjun, Ms. Wang Zheng
and Ms. Li Cui as executive Directors; (ii) Mr. Sun Yuhua as employee representative Director;
(iii) Ms. Lin, Chia-ling, Mr. Diao Juanhuan and Mr. Li Chen as non-executive Directors; and
(iv) Mr. Cai Zhongxi, Dr. Zeng Fanyi, Dr. Ju Dianwen and Mr. Zhang Senquan as independent
non-executive Directors.
52

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性
或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因依
賴該等內容而引致的任何損失承擔任何責任。

Shanghai Bao Pharmaceuticals Co., Ltd.
上海寶濟藥業股份有限公司
（於中華人民共和國成立的股份有限公司）

（股份代號：2659）

截至2026年6月30日止六個月
中期業績公告
上海寶濟藥業股份有限公司（「本公司」），連同其附屬公司統稱「本集團」）董事
（「董事」）會（「董事會」）欣然公佈，本集團截至2026年6月30日止六個月（「報告期
間」）的未經審計簡明綜合中期業績，連同截至2025年6月30日止六個月（「相應期
間」）的比較數字。本集團於報告期間的未經審計中期簡明綜合財務資料已由董事
會及審核委員會審閱。
在本公告中，「我們」指本公司，如文義另有所指，則指本集團。本公告所載若干
金額及百分比數字已約整或已四捨五入至小數點後一位或兩位數（如適用）。任何
表格、圖表或其他部分所示總額與所列金額總和之間的任何差異均由約整所致。

1

業務亮點
於報告期間及直至本公告日期，我們持續快速推進藥物管線的開發進程。下文
載列主要的過往及目前里程碑及成就的概要：
我們的產品進展

核心產品進展
•

KJ017（重組人玻璃酸酶）


KJ017是一種高度糖基化的重組人玻璃酸酶，能特異性分解皮下組織中
的透明質酸，暫時性、局部性增加皮下組織細胞外基質的通透性，從
而實現安全、快速、大容量皮下給藥，為解決靜脈通路困難患者的給
藥難題提供新選擇。相較於傳統動物源性玻璃酸酶（存在過敏風險，使
用前須進行皮試，且批次間質量不穩定），KJ017採用基因重組技術，
通過受控的生產工藝，可實現產品批間質量高度一致、提高安全性，
並顯著降低免疫原性風險，使用前無須進行皮試，提升臨床使用的便
捷性和安全性。



KJ017是中國最為先進的重組人玻璃酸酶。於2026年3月，我們自主研
發的注射用人玻璃酸酶（葆舒宜 ®），規格為385U╱ 瓶，已獲國家藥監
局批准上市，用於輔助皮下輸液（氯化鈉注射液和乳酸鈉林格注射液
等）。



在報告期間，我們在《歐洲藥劑學與生物藥劑學雜誌》
(European Journal
of Pharmaceutics and Biopharmaceutics )發表了兩項有關KJ017的隨機、
雙盲、自我對照III期臨床試驗的結果。結果顯示，KJ017在維持良好安
全性與耐受性的同時，能提升重力驅動式皮下輸注的療效。通過提高
皮下組織的滲透性，KJ017能夠通過皮下途徑在多個部位輸送臨床治療
所需的給藥體積。該等發現支持將KJ017進一步開發為大容量皮下給藥
的輔助製劑，並證明其具有與需要快速或大容量皮下給藥的治療藥物
聯合給藥的潛力。



我們將有序推進KJ017 的商業化準備工作，並評估最適合的商業化模
式，包括與專業商業化服務供應商或具備成熟推廣能力的領先生物製
藥公司進行潛在合作。我們預期將憑藉特選合作夥伴的銷售網絡、分
銷渠道及商業化專業能力，支持KJ017在不同地區的市場准入、醫學事
務、渠道管理及後續商業化工作，從而擴大其市場覆蓋範圍，並實現
其臨床與商業價值。
2



•

截至本公告日期，我們已與多家製藥及生物科技公司（包括藥明生物
(2269.HK)、荃信生物(2509.HK)、上海萊士(002252.SZ)及尚健等）建
立正式合作夥伴關係，共同開發皮下製劑。除上述已公開合作以外，
我們持續積極拓展合作生態系統，已有超過六十家合作夥伴使用我們
的重組人玻璃酸酶用於其產品開發，項目涵蓋從早期研究到臨床開發
的不同階段。由於受保密協議約束，該等合作的詳情未於本公告中披
露。我們的典型合作模式是，我們持續提供我們的重組人玻璃酸酶產
品作為輔料及提供相關技術服務，而合作夥伴則自行出資推進與其候
選藥物聯用的皮下製劑的開發。


於2025年1月，我們與藥明生物(2269.HK)下屬全資子公司上海藥
明生物技術有限公司就重組人玻璃酸酶供應、生產和授權許可達
成戰略合作協議。根據協議，本公司與藥明生物旨在就重組人玻
璃酸酶皮下給藥應用領域實現合作共贏，共同深度開發新業務、
拓展新客戶。



於2026年1月，我們與上海萊士(002252.SZ)下屬全資子公司廣西
萊士生物製藥有限公司共同宣佈，雙方已就基於玻璃酸酶皮下給
藥技術的血液製品新劑型開發達成戰略合作。根據協議，雙方將
結合本公司的皮下給藥技術平台與上海萊士在血液製品領域的領
先優勢，共同開發更具便捷性和患者友好度的新型血液製品治療
方案，旨在提升患者依從性並優化醫療資源利用。

KJ103（重組IgG降解酶）


KJ103是一款全球首創、低免疫原性創新重組免疫球蛋白G（「IgG」）降
解酶，用於治療由病理性IgG抗體所介導的多種免疫性疾病及病症。
KJ103通過結合至IgG恆定區CH2部位，僅在CH1和CH2之間的鉸鏈區
特定位點切割IgG，作用機制明確且免疫原性風險低，可安全、高效、
快速、特異性降解人IgG。



KJ103是全球首款也是唯一一款達到註冊臨床階段的低免疫原性IgG降
解酶，其作為腎臟移植前脫敏及抗腎小球基底膜(GBM)病的適應症已
獲得國家藥監局的突破性療法認定（「BTD」）。KJ103 以血液和組織中
的IgG抗體為靶向，使之降解，從而抑制導致各種免疫疾病的病理性
IgG介導的免疫反應。

3

•



對於腎臟移植前脫敏治療，我們於2025 年8 月開展III期臨床試驗
(CTR20252973)，並於2026 年3 月完成所有入組受試者的主要試驗隨
訪。於2026年5月提交申請後，新藥申請(NDA)於同月獲國家藥監局藥
品審評中心批准納入優先審評程序，並於2026 年6 月獲國家藥監局受
理。對於抗GBM病適應症，我們於2025年10月完成II期臨床試驗，並
於2026 年1 月召開III期臨床試驗啟動會議。對於GBS適應症，我們於
2025年4月獲得國家藥監局的IND批准，並積極推進於2025年11月開展
的II期臨床試驗。



於2026年3月完成的KJ103用於高度致敏腎臟移植患者脫敏治療的III期
臨床試驗(CTR20252973)中，KJ103達成主要終點，並展現出快速且顯
著的脫敏效果。數據顯示，移植前脫敏治療成功率達100%，腎臟移植
成功率亦達100%，且未觀察到超急性排斥反應。KJ103亦展現良好的
安全性，並無與KJ103相關的嚴重不良事件報告。



於2026 年6 月，由本公司發起針對抗GBM病患者早期多次給藥KJ103
(Ricefidase)的II期、開放標籤、單臂、多中心研究結果於第63屆歐洲
腎臟協會(ERA)大會上發表。研究顯示，KJ103可高效、快速並持續清
除抗GBM抗體，並在關鍵療效方面顯示出潛在臨床獲益，為該類危及
生命的罕見自身免疫性疾病提供了新的治療探索方向。



2025年11月，本公司作為關鍵藥物提供企業，承擔了國家科技重大專
項「醫用級供體豬培育及異種移植臨床轉化技術研究」的重要職責。項
目開展過程中，我們利用在重組蛋白、生物酶及免疫調控藥物領域的
研發優勢，為本次異種腎臟移植的長期存活提供了多個免疫干預的關
鍵藥物支持。截至本公告日期，受體猴存活超過660 天且移植腎功能
穩定，刷新了亞洲異種腎臟移植非人靈長類長期存活紀錄，這一成果
顯現了我們為異種移植免疫干預策略的探索與創新提供關鍵支持的能
力，以及推動異種移植未來發展的潛力。

SJ02（晟諾娃 ®）
（長效重組人卵泡刺激素）


SJ02 是一種在中國獲批的長效重組人卵泡刺激素羧基末端肽融合蛋白
(FSH-CTP)，旨在與促性腺激素釋放激素拮抗劑聯合使用，進行控制性
卵巢刺激。該治療方案可有效促進接受促排卵或輔助生殖技術(ART)手
術的女性的多個卵泡發育。

4



在中國，我們於2025 年8 月以獲批藥品名稱絨促卵泡激素α N01 注射
液（晟諾娃 ® ）獲得SJ02 的 NDA批准，並於2025 年 11 月完成交付首批
訂單。於2025 年7 月，我們與安徽安科生物工程（集團）股份有限公司
（「安科生物」，300009.SZ）訂立獨家銷售代理協議，據此，我們向安科
生物授予在中國內地、中國香港、中國澳門及中國台灣（「大中華區」）
營銷、銷售、分銷及推廣SJ02的獨家權利，因此，安科生物將作為獨
家合約銷售組織(CSO)，負責SJ02在該等地區的商業化。



截至2026 年6 月30 日，SJ02 已在中國境內超過29個省完成線上採購平
台掛牌及市場准入手續，並已覆蓋超過70 家醫療機構。截至本公告日
期，安科生物已開展SJ02的實際商業銷售，並持續推進該產品進入醫
院及納入處方的程序。我們將繼續與獨家CSO合作夥伴安科生物密切
合作，優化SJ02的營銷策略，進一步鞏固該產品的市場地位，增強其
學術推廣能力與分銷網絡，並提升其市場滲透率及品牌知名度。

其他選定臨床階段產品的進展
•

KJ101（重組人糜蛋白酶）


KJ101是一種通過合成生物學開發的國內領先的重組人糜蛋白酶。糜蛋
白酶已展示出廣泛的臨床應用，特別是用於燒傷、創傷、手術切口、
壓瘡及糖尿病足潰瘍等傷口癒合。糜蛋白酶為一種蛋白水解酶，歷來
均提取自牛胰腺組織，存在產量低、潛在污染及宗教或道德等方面的
顧慮。基於我們專有的綠色重組酵母發酵技術，KJ101 提供了一種純
淨、更安全且更易於規模化生產的高表達替代方案。此外，KJ101具有
卓越的生物安全性，有效地解決了生化提取物中固有的病毒污染問題。



我們於2025年7月就燒傷、創傷、手術切口、壓瘡及糖尿病足潰瘍等傷
口癒合的適應症開展II期臨床試驗(CTR20252263)，並於2026年6月完
成試驗。



我們於2025 年12 月就KJ101用於胃鏡檢查時溶解去除胃內黏液的適應
症向國家藥監局提交IND申請，於2026年3月獲得IND批准，並於2026
年5月開展I期臨床試驗(CTR20261865)。

5

•

BJ044（重組烏司他丁）


BJ044 是中國乃至全球範圍內潛在的唯一一款透過合成生物學開發的
重組烏司他丁。烏司他丁，又名bikunin，是一種具強抑制活性的糖蛋
白，於1909年首次在人尿液中發現。烏司他丁可廣泛用於治療急性胰
腺炎、慢性復發性胰腺炎的急性惡化期及急性循環衰竭。憑藉其有效
的酶抑制和抗炎特性，烏司他丁已廣泛用於治療一系列危重症疾病，
並具有良好的臨床療效，包括膿毒症、重症肺炎、急性呼吸窘迫綜合
症(ARDS)、急性中毒、嚴重中暑、燒傷及嚴重外傷。
目前在售的源自人尿的烏司他丁產品，依賴於收集並純化尿液的非
標準化生產工藝，存在病毒污染及批次間質量不一致的風險。相比
之下，重組形式的烏司他丁（如BJ044）旨在克服這些限制，提供更穩
定、更高效、更具規模化的生產方式。BJ044採用的重組技術最大限度
降低污染風險並提升臨床使用的安全性，具備純度高、一致性好及成
本效益顯著等優勢，並解決與傳統生化提取方式相關的倫理問題。



•

•

我們於2026年3月向國家藥監局提交BJ044的IND申請。該申請於2026
年6月獲得國家藥監局批准，獲准開展臨床試驗。

KJ015（抗HER2雙特異性抗體（皮下製劑））


KJ015是一種源於通用輕鏈技術的創新抗HER2雙特異性抗體的皮下製
劑，其被設計為擁有兩條帶有通用輕鏈的Fab臂，形成接近天然的IgG1
結構。



我們於2024年12月獲得國家藥監局對KJ015的IND批准，並於2025年6
月開展I期臨床試驗(CTR20251923)。我們預期於2026年下半年完成I期
臨床試驗。



海外開發方面，我們於2026年7月向FDA提交IND申請，並於2026年8
月獲准開展臨床試驗。

BJ007（頭孢曲松鈉（皮下製劑））


BJ007是一種用於治療細菌感染的皮下給藥頭孢曲松鈉製劑。迄今，全
球尚無已獲批准的皮下給藥頭孢曲松鈉產品，而BJ007為該類別首款也
是唯一一款進入臨床階段的候選藥物。這一創新減少了血管通路和使
用長期靜脈導管的需求，提供了更方便、更安全且成本更低的給藥選
擇。因此，BJ007可提供非劣效的治療獲益，同時避免了頭孢曲松的較
長療程中通常需要輸液管路所帶來的相關風險、不適和成本，同時克
服了困難靜脈通路(DIVA)患者在治療中面臨的主要難題。
6



於2025年2月，我們獲得國家藥監局的IND批准。獲批後，我們於2025
年8月開展BJ007的I期臨床試驗(CTR20253085)，並於2026年1月完成
該試驗。我們目前正就開展關鍵性臨床試驗與CDE進行溝通，並預期
於2026年下半年啟動有關試驗。



海外開發方面，BJ007的IND申請於2026年5月獲得FDA批准，獲准開
展臨床試驗。我們預期於2026年下半年開展臨床試驗。

其他選定產品的進展
•

•

BJ045（抗酶切的抗CD20抗體（皮下製劑））


BJ045是一款皮下給藥的抗KJ103酶切的抗CD20抗體，具有與KJ103聯
用治療中重度自身免疫性疾病的潛力。BJ045與KJ103聯合使用可產生
協同作用，能夠切割現存IgG抗體、快速消除病理性IgG抗體對正常組
織的損害及調控病理性IgG抗體的產生。此外，憑藉我們在皮下給藥候
選藥物方面的競爭優勢，BJ045的皮下注射給藥方式有望改善治療體驗
及患者依從性。



我們於2026年7月向國家藥監局提交BJ045的IND申請，並預期於2026
年下半年獲得國家藥監局的IND批准。

BJ047（抗酶切的抗CD154抗體（皮下製劑））


BJ047是一種皮下給藥的抗KJ103酶切的抗CD154抗體，專為實體器官
移植、異種移植、自身免疫性疾病（狼瘡腎炎、多發性硬化症、IgG4
相關性疾病等）而開發。BJ047的抗酶切能力進一步提高其抵抗體內酶
分解的穩定性，從而確保持續的免疫抑制並促進異種移植物的長期存
活。這有助於在目標適應症中產生協同效應。例如，其與可有效降解
抗異種移植抗體的KJ103聯合使用時，將進一步從源頭抑制異種移植中
病理性抗體的生成，並減輕其影響。此外，憑藉優越的便利性及治療
的靈活性，BJ047作為創新的治療方案有潛力在市場上脫穎而出。



我們預期於2026年下半年向國家藥監局提交BJ047的IND申請。

7

8

單藥

單藥

重組人糜蛋白酶

重組烏司他丁

KJ101

BJ044

國家藥監局突破性療法認定

單藥

重組人絨促性素

SJ04

主要適應症

重組人FSH-CTP

SJ02
(Slonva®
(晟諾娃®))5,7

單藥

單藥

抗酶切的抗CD154抗體
（皮下製劑）

BJ047

單藥

重組IgG降解酶

KJ1034

單藥

單藥

抗HER2雙特異性抗體
（皮下製劑）

KJ015

抗酶切的抗CD20抗體
（皮下製劑）

單藥

頭孢唑林鈉（皮下製劑）

BJ0093

BJ045

單藥

頭孢哌酮鈉舒巴坦鈉
（皮下製劑）

BJ0083

單藥

頭孢曲松鈉（皮下製劑）

BJ0073

治療線數

一線

病理性IgG介導的
自身免疫性疾病6

於2026年3月獲得NDA批准

當前狀態╱里程碑

一線

一線

急性胰腺炎、
慢性復發性胰腺炎
及急性循環衰竭

一線

燒傷、創傷、手術切口、
壓瘡及糖尿病足潰瘍等
傷口癒合
用於胃鏡檢查時
溶解去除胃內黏液

一線

刺激卵泡成熟、
觸發排卵和黃體化

國家藥監局

國家藥監局

國家藥監局

國家藥監局

EMA

生物製品

生物製品

生物製品

生物製品

生物類似藥

於2026年6月獲得國家藥監局的IND批准；
預計於2026年下半年開展I期試驗

I期試驗階段；
預計於2026年下半年完成I期試驗

於2026年6月完成II期試驗；
預計於2027年啟動III期試驗

於2025年9月完成I期試驗

臨床前階段；預計於2027年提交IND申請

於2025年8月獲得NDA批准
生物製品

一線

國家藥監局

控制性卵巢刺激、
刺激多個卵泡發育、
促進排卵

臨床前階段；
預計於2026年下半年提交IND申請
生物製品

於2026年7月提交IND申請；
預計於2026年下半年獲得IND批准

於2025年11月啟動II期試驗；
預計於2026年下半年完成患者入組

國家藥監局

生物製品

生物製品

生物製品

CXSL2600415

CXSL2501119

CXSL2400781

CXSL2400176

國藥准字S20250049；
國藥准字S20250050

CXSL2500128

CXSL2400378

IND 160657
於2025年10月完成II期試驗；
預計於2026年下半年啟動III期試驗；
於2025年7月從國家藥監局獲得BTD

預計於2027年就開展
關鍵性臨床試驗與FDA溝通

創新生物製品9

CXSL2200266

於2026年6月提交NDA申請；
預計於2027年獲得NDA批准；
於2024年11月從國家藥監局獲得BTD

生物製品

實體器官移植、異種移植、
自身免疫性疾病（狼瘡腎炎、
一線
多發性硬化症、
IgG4相關性疾病等）

國家藥監局

國家藥監局

FDA

國家藥監局

IND181553

CXSL2400672

於2026年8月取得IND批准

I期試驗階段；預計於2026年下半年完成I期試驗

生物製品

CXHL2500565

IND 179838

CXHL2401399

國藥准字S20260020

IND/NDA申請編號╱
藥品批准文號

創新生物製品9

國家藥監局
FDA

I期試驗階段

臨床前階段

於2026年5月獲得FDA的IND批准；
預計於2026年下半年開展臨床試驗

化學藥品

化學藥品

改良型化學藥品8

國家藥監局

國家藥監局

FDA

國家藥監局

一線

生物製品

藥物分類

於2026年1月完成I期試驗；
預計於2026年下半年進入關鍵性臨床試驗

NDA

化學藥品

III期

國家藥監局

II期

臨床前階段；預計於2026年下半年
提交一項IND申請

I期

改良型新藥8

IND

EMA/FDA

國家藥監局

臨床前

一線

中重度自身免疫性疾病

GBS

一線

一線

腎臟移植前脫敏

抗GBM病

一線

一線

一線

一線

實體瘤

細菌感染

細菌感染

細菌感染

大容量皮下給藥（組合藥）、
由於各種原因導致的
一線
體液流失（單藥）、
輔助皮下補液（組合藥）

適應症

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

來源

全球

全球

全球

全球

全球

全球

全球

全球

全球

全球

全球

全球

商業化權利

縮寫：BTD=突破性療法認定；FSH-CTP=卵泡刺激素羧基末端肽；GBM=腎小球基底膜；GBS=吉蘭 － 巴雷綜合症；H1=上半年；
H2=下半年；IgG=免疫球蛋白G；SC=皮下。

核心產品

合成生物學升級平台

輔助生殖

抗體介導的
自身免疫性疾病

皮下給藥

單藥╱組合藥

重組人玻璃酸酶2

KJ017
(葆舒宜®)1

療法

關鍵成份

候選藥物

下圖概述我們截至本公告日期的選定候選藥物的開發狀況：

產品管線

9

我們一直擔任唯一申辦者，負責為KJ017在中國的各個臨床開發階段提供資金，並預期就KJ017在歐洲及美國的未來臨床開發繼
續擔任唯一申辦者。

我們已在中國完成藥用輔料註冊，並正推進全球註冊進程。KJ017的藥物主文件(DMF)於2025年5月成功向FDA備案。

抗生素皮下製劑是基於化學藥物改良（2.2類）新給藥途徑研發，後續研究放在藥物曲線下面積(AUC)等效性及PK/PD。

我們一直擔任唯一申辦者，負責為KJ103在中國的各個臨床開發階段提供資金，並預期就KJ103在美國的未來臨床開發繼續擔任
唯一申辦者。

我們一直擔任唯一申辦者，負責為SJ02在中國的各個臨床開發階段提供資金，並預期就SJ02在歐洲的未來臨床開發繼續擔任唯
一申辦者。

病理性IgG介導的自身免疫性疾病是指免疫系統產生針對人體自身細胞、組織或器官的異常IgG抗體而引發的一組失調疾病。

我們於2025年7月與安科生物訂立獨家銷售代理協議，據此，安科生物將作為獨家CSO，負責SJ02在大中華區的商業化。

該定義乃根據《聯邦食品、藥品和化妝品法》第505(b)(2)條確立。

該定義乃根據《公共衛生服務法》第351(a)條確立。

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

附註：

財務亮點
截至6月30日止六個月
2026年
2025年
（未經審計） （經審計）
人民幣千元 人民幣千元
研發開支
行政開支
期內虧損

(92,570)
(40,616)
(153,685)

(111,045)
(46,153)
(183,096)

我們的研發開支由截至2025年6月30日止六個月的人民幣111.0百萬元減少人民
幣18.5 百萬元或16.6%至截至2026 年6 月30 日止六個月的人民幣92.6 百萬元。
減少主要由於：(i)與向我們的研發人員授出股份激勵相關的以股份為基礎的付
款開支減少人民幣20.1百萬元，部分被(ii)隨著我們推進候選藥物的持續臨床開
發，試驗及測試費用增加人民幣13.8百萬元所抵銷。
我們的行政開支由截至2025年6月30日止六個月的人民幣46.2百萬元減少人民幣
5.5百萬元或12.0%至截至2026年6月30日止六個月的人民幣40.6百萬元。減少主
要由於我們向管理層及行政人員授予股份激勵而產生以股份為基礎的付款開支
減少。
於2025年
於2026年
12月31日
6月30日
（未經審計） （經審計）
人民幣千元 人民幣千元
現金及現金等價物
總資產
總權益

1,042,096
2,169,835
1,448,724

1,241,609
2,216,979
1,591,974

其他亮點


2026年4月，經上海市總工會推薦，本公司在全國表彰大會上獲頒全國五一
勞動獎狀，是上海市獲得該獎項的25家企業之一。

10

管理層討論及分析
業務概覽
我們是一家於2019年成立的生物技術公司，戰略性聚焦四大領域：(i)大容量皮下
給藥；(ii)抗體介導的自身免疫性疾病；(iii)輔助生殖；及(iv)重組生物製藥。我們
的產品組合主要包括12款自主開發的產品及候選產品，包括三款核心產品（KJ017
（葆舒宜 ® ）、KJ103 及SJ02（晟諾娃 ® ））、六款其他臨床階段候選產品（KJ101、
BJ044、KJ015、BJ007、BJ009 及 SJ04）及三款臨床前產品（BJ045、BJ047 及
BJ008）。我們的核心產品包括：(i)KJ017（葆舒宜 ®），是一款重組人玻璃酸酶，其
規格為385U╱ 瓶，於2026年3月獲國家藥監局批准上市，用於輔助皮下輸液（氯
化鈉注射液和乳酸鈉林格注射液等）；(ii)KJ103，是一款創新重組免疫球蛋白G
(IgG)降解酶，其就高度致敏腎移植患者脫敏治療的NDA於2026年5月獲納入優先
審評程序，並於2026年6月獲國家藥監局受理；及(iii)SJ02（晟諾娃 ®），是一款用
於輔助生殖的長效重組人卵泡刺激素羧基末端肽融合蛋白(FSH-CTP)，於2025年8
月獲得國家藥監局的NDA批准。

11

12

單藥

單藥

重組人糜蛋白酶

重組烏司他丁

KJ101

BJ044

國家藥監局突破性療法認定

單藥

重組人絨促性素

SJ04

主要適應症

重組人FSH-CTP

SJ02
(Slonva®
(晟諾娃®))5,7

單藥

單藥

抗酶切的抗CD154抗體
（皮下製劑）

BJ047

單藥

重組IgG降解酶

KJ1034

單藥

單藥

抗HER2雙特異性抗體
（皮下製劑）

KJ015

抗酶切的抗CD20抗體
（皮下製劑）

單藥

頭孢唑林鈉（皮下製劑）

BJ0093

BJ045

單藥

頭孢哌酮鈉舒巴坦鈉
（皮下製劑）

BJ0083

單藥

頭孢曲松鈉（皮下製劑）

BJ0073

治療線數

一線

病理性IgG介導的
自身免疫性疾病6

8

於2026年3月獲得NDA批准

當前狀態╱里程碑

一線

一線

急性胰腺炎、
慢性復發性胰腺炎
及急性循環衰竭

一線

燒傷、創傷、手術切口、
壓瘡及糖尿病足潰瘍等
傷口癒合
用於胃鏡檢查時
溶解去除胃內黏液

一線

刺激卵泡成熟、
觸發排卵和黃體化

國家藥監局

國家藥監局

國家藥監局

國家藥監局

EMA

生物製品

生物製品

生物製品

生物製品

生物類似藥

於2026年6月獲得國家藥監局的IND批准；
預計於2026年下半年開展I期試驗

I期試驗階段；
預計於2026年下半年完成I期試驗

於2026年6月完成II期試驗；
預計於2027年啟動III期試驗

於2025年9月完成I期試驗

臨床前階段；預計於2027年提交IND申請

於2025年8月獲得NDA批准
生物製品

一線

國家藥監局

控制性卵巢刺激、
刺激多個卵泡發育、
促進排卵

臨床前階段；
預計於2026年下半年提交IND申請
生物製品

於2026年7月提交IND申請；
預計於2026年下半年獲得IND批准

於2025年11月啟動II期試驗；
預計於2026年下半年完成患者入組

CXSL2600415

CXSL2501119

CXSL2400781

CXSL2400176

國藥准字S20250049；
國藥准字S20250050

CXSL2500128

CXSL2400378

IND 160657

預計於2027年就開展
關鍵性臨床試驗與FDA溝通
於2025年10月完成II期試驗；
預計於2026年下半年啟動III期試驗；
於2025年7月從國家藥監局獲得BTD

CXSL2200266

於2026年6月提交NDA申請；
預計於2027年獲得NDA批准；
於2024年11月從國家藥監局獲得BTD

國家藥監局

生物製品

生物製品

生物製品

創新生物製品9

生物製品

IND181553

CXSL2400672

CXHL2500565

IND 179838

CXHL2401399

國藥准字S20260020

IND/NDA申請編號╱
藥品批准文號

於2026年8月取得IND批准

實體器官移植、異種移植、
自身免疫性疾病（狼瘡腎炎、
一線
多發性硬化症、
IgG4相關性疾病等）

國家藥監局

國家藥監局

FDA

國家藥監局

創新生物製品9

I期試驗階段；預計於2026年下半年完成I期試驗

生物製品

國家藥監局
FDA

I期試驗階段

臨床前階段

化學藥品

化學藥品

改良型化學藥品

於2026年5月獲得FDA的IND批准；
預計於2026年下半年開展臨床試驗

國家藥監局

國家藥監局

FDA

國家藥監局

一線

生物製品

藥物分類

於2026年1月完成I期試驗；
預計於2026年下半年進入關鍵性臨床試驗

NDA

化學藥品

III期

國家藥監局

II期

臨床前階段；預計於2026年下半年
提交一項IND申請

I期

改良型新藥8

IND

EMA/FDA

國家藥監局

臨床前

一線

中重度自身免疫性疾病

GBS

一線

一線

腎臟移植前脫敏

抗GBM病

一線

一線

一線

一線

實體瘤

細菌感染

細菌感染

細菌感染

大容量皮下給藥（組合藥）、
由於各種原因導致的
一線
體液流失（單藥）、
輔助皮下補液（組合藥）

適應症

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

自主開發

來源

全球

全球

全球

全球

全球

全球

全球

全球

全球

全球

全球

全球

商業化權利

縮寫：BTD=突破性療法認定；FSH-CTP=卵泡刺激素羧基末端肽；GBM=腎小球基底膜；GBS=吉蘭 － 巴雷綜合症；H1=上半年；H2=
下半年；IgG=免疫球蛋白G；SC=皮下。

核心產品

合成生物學升級平台

輔助生殖

抗體介導的
自身免疫性疾病

皮下給藥

單藥╱組合藥

重組人玻璃酸酶2

KJ017
(葆舒宜®)1

療法

關鍵成份

候選藥物

下圖概述我們截至本公告日期的選定候選藥物的開發狀況：

產品管線

13

我們一直擔任唯一申辦者，負責為KJ017在中國的各個臨床開發階段提供資金，並預期就KJ017在歐洲及美國的未來臨床開發繼
續擔任唯一申辦者。

我們已在中國完成藥用輔料註冊，並正推進全球註冊進程。KJ017的DMF於2025年5月成功向FDA備案。

抗生素皮下製劑是基於化學藥物改良（2.2類）新給藥途徑研發，後續研究放在藥物曲線下面積(AUC)等效性及PK/PD。

我們一直擔任唯一申辦者，負責為KJ103在中國的各個臨床開發階段提供資金，並預期就KJ103在美國的未來臨床開發繼續擔任
唯一申辦者。

我們一直擔任唯一申辦者，負責為SJ02在中國的各個臨床開發階段提供資金，並預期就SJ02在歐洲的未來臨床開發繼續擔任唯一
申辦者。

病理性IgG介導的自身免疫性疾病是指免疫系統產生針對人體自身細胞、組織或器官的異常IgG抗體而引發的一組失調疾病。

我們於2025年7月與安科生物訂立獨家銷售代理協議，據此，安科生物將作為獨家CSO，負責SJ02在大中華區的商業化。

該定義乃根據《聯邦食品、藥品和化妝品法》第505(b)(2)條確立。

該定義乃根據《公共衛生服務法》第351(a)條確立。

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

附註：

我們的候選產品
於報告期間及直至本公告日期，我們持續推進管線的開發進程。截至本公告日
期，我們的主要成就及後續計劃包括：

•

KJ017（重組人玻璃酸酶）


KJ017 是一種高度糖基化的重組人玻璃酸酶，能特異性分解皮下組織中
的透明質酸，暫時性、局部性增加皮下組織細胞外基質的通透性，從而
實現安全、快速、大容量皮下給藥，為解決靜脈通路困難患者的給藥難
題提供新選擇。相較於傳統動物源性玻璃酸酶（存在過敏風險，使用前
須進行皮試，且批次間質量不穩定），KJ017採用基因重組技術，通過受
控的生產工藝，可實現產品批間質量高度一致、提高安全性，並顯著降
低免疫原性風險，使用前無須進行皮試，提升臨床使用的便捷性和安全
性。



KJ017是中國最為先進的重組人玻璃酸酶。於2026年3月，我們自主研發
的注射用人玻璃酸酶（葆舒宜 ®），規格為385U╱ 瓶，已獲國家藥監局批
准上市，用於輔助皮下輸液（氯化鈉注射液和乳酸鈉林格注射液等）。



截至本公告日期，我們已取得以下進展及里程碑，並就下步計劃開展的
工作規劃如下：
o

我們於2024年向國家藥監局提交KJ017的NDA申請。於2025年，我
們已通過國家藥監局對KJ017 臨床試驗所在醫院及生物分析實驗室
的GCP檢查，並通過國家藥監局對KJ017的上市前GMP合規檢查。
於2026年3月，我們自主研發的注射用人玻璃酸酶（葆舒宜 ®），規格
為385U╱ 瓶，已獲國家藥監局批准上市，用於輔助皮下輸液（氯化
鈉注射液和乳酸鈉林格注射液等）。

o

在報告期間，我們在《歐洲藥劑學與生物藥劑學雜誌》( E u r o p e a n
Journal of Pharmaceutics and Biopharmaceutics )發表了兩項有關
KJ017 的隨機、雙盲、自我對照III期臨床試驗的結果。結果顯示，
KJ017 在維持良好安全性與耐受性的同時，能提升重力驅動式皮下
輸注的療效。通過提高皮下組織的滲透性，K J017 能夠通過皮下
途徑在多個部位輸送臨床治療所需的給藥體積。該等發現支持將
KJ017 進一步開發為大容量皮下給藥的輔助製劑，並證明其具有與
需要快速或大容量皮下給藥的治療藥物聯合給藥的潛力。

14

o

我們將繼續有序推進KJ017 的商業化準備工作，同時評估及挑選最
適合的商業化模式，包括與專業商業化服務供應商或具備成熟推廣
能力的領先生物製藥公司進行潛在合作。我們預期將憑藉特選合
作夥伴的廣泛銷售網絡、成熟分銷渠道及商業化專業能力，支持
KJ017 在不同地區的市場准入、醫學事務、渠道管理及後續商業化
工作，從而擴大其市場覆蓋範圍。在挑選潛在的合作夥伴時，我們
將全方位評估產品可及性及競爭格局等因素，旨在實現KJ017 的臨
床與商業價值。

o

截至本公告日期，我們已與多家製藥及生物科技公司（包括藥明生物
(2269.HK)、荃信生物(2509.HK)、上海萊士(002252.SZ)及尚健等）
建立正式合作夥伴關係，共同開發皮下製劑。除上述已公開合作以
外，我們持續積極拓展合作生態系統，已有超過六十家合作夥伴使
用我們的重組人玻璃酸酶用於其產品開發，項目涵蓋從早期研究到
臨床開發的不同階段。由於受保密協議約束，該等合作的詳情未於
本公告中披露。我們的典型合作模式是，我們持續提供我們的重組
人玻璃酸酶產品作為輔料及提供相關技術服務，而合作夥伴則自行
出資推進與其候選藥物聯用的皮下製劑的開發。


於2026年1月，我們與上海萊士(002252.SZ)下屬全資子公司廣
西萊士生物製藥有限公司共同宣佈，雙方已就基於玻璃酸酶皮
下給藥技術的血液製品新劑型開發達成戰略合作。根據協議，
雙方將結合本公司的皮下給藥技術平台與上海萊士在血液製品
領域的領先優勢，共同開發更具便捷性和患者友好度的新型血
液製品治療方案，旨在提升患者依從性並優化醫療資源利用。



於2025年1月，我們與藥明生物(2269.HK)下屬全資子公司上海
藥明生物技術有限公司就重組人玻璃酸酶供應、生產和授權許
可達成戰略合作協議。根據協議，本公司與藥明生物旨在就重
組人玻璃酸酶皮下給藥應用領域實現合作共贏，共同深度開發
新業務、拓展新客戶。

15



於2024 年8 月，我們與荃信生物訂立技術服務與供應協議，以
共同開發由荃信生物擁有、正在開發或將開發的與我們的重組
人玻璃酸酶聯合使用的選定原研生物產品的創新皮下製劑。
荃信生物對我們而言屬獨立第三方，是一家領先的生物技術公
司，專注於自身免疫性疾病及過敏性疾病的生物療法。
根據該協議，荃信生物將作為根據該協議開發的皮下製劑的上
市許可持有人，並享有其獨家開發、製造及商業化的權利，及
承擔所有相關成本。我們同意為產品開發提供重組人玻璃酸
酶，提供必要的技術支持及協助進行監管備案。

o

於2025 年5月，我們成功向FDA備案KJ017 的DMF。我們正在準備
歐洲藥品管理局(EMA)和FDA的IND申報，並計劃向EMA和FDA提
交KJ017的IND申請。我們預計於2026年下半年向FDA提交申請，
並之後完成另一地區的IND申請。我們的KJ017在多種治療方式（包
括抗體藥物及化學藥品（尤其是抗生素））上展現出廣泛的應用，使
皮下給藥成為可能，並具有提高藥物安全性、患者便利性和療效的
潛力。

根據上市規則第18A.08(3)條發出的警告：概不保證將能在中國成功商業化
KJ017，或最終將成功就KJ017的其他適應症及製劑進行開發及銷售，或在海外市
場進行銷售。

•

KJ103（重組IgG降解酶）


KJ103是一款全球首創、低免疫原性創新重組免疫球蛋白G（「IgG」）降解
酶，用於治療由病理性IgG抗體所介導的多種免疫性疾病及病症。KJ103
通過結合至IgG恆定區CH2部位，僅在CH1和CH2之間的鉸鏈區特定位點
切割IgG，作用機制明確且免疫原性風險低，可安全、高效、快速、特異
性降解人IgG。



KJ103是全球首款也是唯一一款達到註冊臨床階段的低免疫原性IgG降解
酶，其作為腎臟移植前脫敏及抗GBM病的適應症已獲得國家藥監局的突
破性療法認定（「BTD」）。KJ103以血液和組織中的IgG抗體為靶向，使之
降解，從而抑制導致各種免疫疾病的病理性IgG介導的免疫反應。

16



截至本公告日期，我們已取得以下進展及里程碑，並就下步計劃開展的
工作規劃如下：
o

對於腎臟移植前脫敏治療，我們於 2025 年 8 月開展 III 期臨床試驗
(CTR20252973)，並於2026年3月完成所有入組受試者的主要試驗隨
訪。於2026年5月提交申請後，NDA於同月獲國家藥監局藥品審評
中心批准納入優先審評程序，並於2026 年6 月獲國家藥監局受理。
我們預計於2027年獲得NDA批准。
於2026年3月完成的KJ103用於高度致敏腎臟移植患者脫敏治療的III
期臨床試驗(CTR20252973)中，KJ103達成主要終點，並展現出快速
且顯著的脫敏效果。數據顯示，移植前脫敏治療成功率達100%，腎
臟移植成功率亦達100%，且未觀察到超急性排斥反應。KJ103亦展
現良好的安全性，並無與KJ103相關的嚴重不良事件報告。

o

對於抗GBM病適應症，我們於2026年1月召開III期臨床試驗啟動會
議。我們預計於2026年下半年開展III期臨床試驗。
在KJ103用於抗GBM病的II期臨床試驗(CTR20243543)中，3個月整
體存活率為100.0%，其中66.7%的患者無需透析並可保留腎功能。
在使用KJ103治療6.0個月後，整體存活率為100.0%，其中75.0%的
患者無需透析並可保留腎功能。與歷史數據的療效對比分析表明，
KJ103 顯示出明顯的臨床優勢。接受當前標準強化治療的病患的歷
史數據顯示，給藥3.0 個月後的整體存活率為81.2%，其中僅30.6%
的患者無需透析並可保留腎功能。KJ103具有良好的安全性，並無
藥物相關的嚴重不良事件報告。
於2026年6月，針對抗GBM病患者早期多次給藥KJ103 (Ricefidase)
的II期、開放標籤、單臂、多中心研究結果於第63 屆歐洲腎臟協會
(ERA)大會上發表。研究顯示，KJ103 可高效、快速並持續清除抗
GBM抗體，並在關鍵療效方面顯示出潛在臨床獲益，為該類危及生
命的罕見自身免疫性疾病提供了新的治療探索方向。

o

對於GBS適應症，我們於2025年11月開展II期臨床試驗，並預計於
2026年下半年完成患者入組。

17

o

2025年11月，本公司作為關鍵藥物提供企業，承擔了國家科技重大
專項「醫用級供體豬培育及異種移植臨床轉化技術研究」的重要職
責。項目開展過程中，我們利用在重組蛋白、生物酶及免疫調控藥
物領域的研發優勢，為本次異種腎臟移植的長期存活提供了多個免
疫干預的關鍵藥物支持。截至本公告日期，受體猴存活超過660天且
移植腎功能穩定，刷新了亞洲異種腎臟移植非人靈長類長期存活紀
錄，這一成果顯現了我們為異種移植免疫干預策略的探索與創新提
供關鍵支持的能力，以及推動異種移植未來發展的潛力。

o

就KJ103靶向病理性IgG介導自身免疫疾病的海外項目，我們於2026
年8 月向FDA提交了GBS適應症的孤兒藥資格認定申請，並預期於
2027年就開展關鍵性臨床試驗與FDA進行溝通。

根據上市規則第18A.08(3)條發出的警告：概不保證本公司最終將能夠成功開發及
銷售KJ103。

•

SJ02（晟諾娃 ®）
（長效重組人卵泡刺激素）


SJ02 是一種在中國獲批的長效重組人卵泡刺激素羧基末端肽融合蛋白
(FSH-CTP)，旨在與促性腺激素釋放激素拮抗劑聯合使用，進行控制性
卵巢刺激。SJ02是中國首款獲批的長效FSH-CTP產品。
SJ02治療方案可有效促進接受促排卵或輔助生殖技術手術的女性的多個
卵泡發育。SJ02以傳統的短效FSH為基礎，通過將人絨毛膜促性腺激素
β亞基的CTP序列與FSH β亞基的C端融合而在結構上加強。此改構可將
FSH的體內半衰期顯著延長兩至三倍，而不會影響其功能性。SJ02 的長
效特性使單次注射可以替代短效FSH連續七天注射。通過將給藥間隔從
每天延長至每週，SJ02可提供更大的便利性，最大限度地減少注射帶來
的不適，提升患者的整體治療體驗及生活質量。

18



截至本公告日期，我們已取得以下進展及里程碑，並就下步計劃開展的
工作規劃如下：
o

在中國，我們於2025年8月以獲批藥品名稱絨促卵泡激素α N01注射
液（晟諾娃 ®）獲得SJ02的NDA批准，並於2025年11月完成交付首批
訂單。
於2025 年7 月，我們與安科生物訂立獨家銷售代理協議，據此，我
們向安科生物授予在大中華區營銷、銷售、分銷及推廣SJ02的獨家
權利，因此，安科生物將作為獨家CSO，負責SJ02在該等地區的商
業化。截至2026年6月30日，SJ02已在中國境內超過29個省完成線
上採購平台掛牌及市場准入手續，並已覆蓋超過70家醫療機構。截
至本公告日期，安科生物已開展SJ02的實際商業銷售，並持續推進
該產品進入醫院及納入處方的程序。我們將繼續與獨家CSO合作夥
伴安科生物密切合作，優化SJ02的營銷策略，進一步鞏固該產品的
市場地位，增強其學術推廣能力與分銷網絡，並提升其市場滲透率
及品牌知名度。

o

在歐洲，我們計劃於2027年向EMA提交SJ02的IND申請。

根據上市規則第18A.08(3)條發出的警告：概不保證將能繼續在大中華區成功商業
化SJ02，或將最終成功開發及在海外市場銷售SJ02。

•

KJ101（重組人糜蛋白酶）


KJ101 是一種通過合成生物學開發的國內領先的重組人糜蛋白酶。糜蛋
白酶已展示出廣泛的臨床應用，特別是用於燒傷、創傷、手術切口、壓
瘡及糖尿病足潰瘍等傷口癒合。糜蛋白酶為一種蛋白水解酶，歷來均提
取自牛胰腺組織，存在產量低、潛在污染及宗教或道德等方面的顧慮。
基於我們專有的綠色重組酵母發酵技術，KJ101提供了一種純淨、更安
全且更易於規模化生產的高表達替代方案。此外，KJ101具有卓越的生
物安全性，有效地解決了生化提取物中固有的病毒污染問題。



我們於2025年2月獲得國家藥監局對KJ101就燒傷、創傷、手術切口、壓
瘡及糖尿病足潰瘍等傷口癒合的適應症的IND批准，於2025年7月開展II
期臨床試驗(CTR20252263)，並於2026年6月完成試驗。我們預計於2027
年開展III期臨床試驗。



我們於2025年12月就用於胃鏡檢查時溶解去除胃內黏液的適應症向國家
藥監局提交IND申請，於2026年3月獲得IND批准，並於2026年5月開展
I期臨床試驗(CTR20261865)。我們預計於2026年下半年完成I期臨床試
驗。
19

•

BJ044（重組烏司他丁）


BJ044 是中國乃至全球範圍內潛在的唯一一款透過合成生物學開發的重
組烏司他丁。烏司他丁，又名bikunin，是一種具強抑制活性的糖蛋白，
於1909年首次在人尿液中發現。烏司他丁可廣泛用於治療急性胰腺炎、
慢性復發性胰腺炎的急性惡化期及急性循環衰竭。憑藉其有效的酶抑制
和抗炎特性，烏司他丁已廣泛用於治療一系列危重症疾病，並具有良好
的臨床療效，包括膿毒症、重症肺炎、急性呼吸窘迫綜合症(ARDS)、急
性中毒、嚴重中暑、燒傷及嚴重外傷。
目前在售的源自人尿的烏司他丁產品，依賴於收集並純化尿液的非標準
化生產工藝，存在病毒污染及批次間質量不一致的風險。相比之下，
重組形式的烏司他丁（如BJ044）旨在克服這些限制，提供更穩定、更高
效、更具規模化的生產方式。BJ044 採用的重組技術最大限度降低污染
風險並提升臨床使用的安全性，具備純度高、一致性好及成本效益顯著
等優勢，並解決與傳統生化提取方式相關的倫理問題。



•

•

我們於2026年3月向國家藥監局提交BJ044的IND申請。該申請於2026年
6 月獲得國家藥監局批准，獲准開展臨床試驗。我們預期於2026 年下半
年開展I期臨床試驗。

KJ015（抗HER2雙特異性抗體（皮下製劑））


KJ015 是一種源於通用輕鏈技術的創新抗HER2 雙特異性抗體的皮下製
劑，其被設計為擁有兩條帶有通用輕鏈的Fab臂，形成接近天然的IgG1
結構。



我們於2024年12月獲得國家藥監局對KJ015的IND批准，並於2025年6月
開展I期臨床試驗(CTR20251923)。我們預期於2026年下半年完成I期臨
床試驗。



海外開發方面，我們於2026年7月向FDA提交IND申請，並於2026年8月
獲准開展臨床試驗。

BJ045（抗酶切的抗CD20抗體（皮下製劑））


BJ045是一款皮下給藥的抗KJ103酶切的抗CD20抗體，具有與KJ103聯
用治療中重度自身免疫性疾病的潛力。BJ045與KJ103聯合使用可產生協
同作用，能夠切割現存IgG抗體、快速消除病理性IgG抗體對正常組織的
損害及調控病理性IgG抗體的產生。此外，憑藉我們在皮下給藥候選藥
物方面的競爭優勢，BJ045 的皮下注射給藥方式有望改善治療體驗及患
者依從性。
20



•

•

我們於2026年7月向國家藥監局提交BJ045的IND申請，並預期於2026年
下半年獲得國家藥監局的IND批准。

BJ047（抗酶切的抗CD154抗體（皮下製劑））


BJ047 是一種皮下給藥的抗KJ103 酶切的抗CD154 抗體，專為實體器官
移植、異種移植、自身免疫性疾病（狼瘡腎炎、多發性硬化症、IgG4 相
關性疾病等）而開發。BJ047的抗酶切能力進一步提高其抵抗體內酶分解
的穩定性，從而確保持續的免疫抑制並促進異種移植物的長期存活。這
有助於在目標適應症中產生協同效應。例如，其與可有效降解抗異種移
植抗體的KJ103 聯合使用時，將進一步從源頭抑制異種移植中病理性抗
體的生成，並減輕其影響。此外，憑藉優越的便利性及治療的靈活性，
BJ047作為創新的治療方案有潛力在市場上脫穎而出。



我們預期於2026年下半年向國家藥監局提交BJ047的IND申請。

BJ007（頭孢曲松鈉（皮下製劑））


BJ007 是一種用於治療細菌感染的皮下給藥頭孢曲松鈉製劑。迄今，全
球尚無已獲批准的皮下給藥頭孢曲松鈉產品，而BJ007 為該類別首款也
是唯一一款進入臨床階段的候選藥物。這一創新減少了血管通路和使用
長期靜脈導管的需求，提供了更方便、更安全且成本更低的給藥選擇。
因此，BJ007 可提供非劣效的治療獲益，同時避免了頭孢曲松的較長療
程中通常需要輸液管路所帶來的相關風險、不適和成本，同時克服了
DIVA患者在治療中面臨的主要難題。



於2025 年2 月，我們獲得國家藥監局的IND批准。獲批後，我們於2025
年8 月開展BJ007 的I期臨床試驗(CTR20253085)，並於2026 年1 月完成
該試驗。我們目前正就開展關鍵性臨床試驗與CDE進行溝通，並預期於
2026年下半年啟動有關試驗。



海外開發方面，BJ007的IND申請於2026年5月獲得FDA批准，獲准開展
臨床試驗。獲批的臨床試驗為一項隨機、開放標籤臨床試驗，旨在評估
皮下輸注用BJ007 與靜脈輸注用頭孢曲松鈉在健康受試者中的藥代動力
學特徵、絕對生物利用度及PK/PD有效性。我們預期於2026年下半年開
展臨床試驗。

21

•

•

•

BJ008（頭孢哌酮鈉舒巴坦鈉（皮下製劑））


BJ008 是一款頭孢哌酮鈉舒巴坦鈉的創新皮下製劑。頭孢哌酮鈉舒巴坦
鈉是一種常用的複方製劑，用於治療細菌感染，涵蓋呼吸道感染、尿路
感染、腹腔內感染、婦科感染、皮膚和軟組織感染、骨骼和關節感染、
細菌性敗血症、腦膜炎、心內膜炎，以及外科預防性用藥。頭孢哌酮是
一種第三代頭孢菌素類抗生素，與舒巴坦鈉（一種不可逆的β－ 內酰胺酶
抑制劑）聯用時，對革蘭氏陰性菌具有很強的協同抗菌活性，且穩定性
良好。通過利用我們的大容量皮下給藥系統，BJ008 具備以皮下注射取
代現有頭孢哌酮鈉舒巴坦鈉靜脈輸注的潛力，可同時降低併發症的風險
並提高患者依從性。



我們將按計劃積極推進BJ008臨床前研究工作。

BJ009（頭孢唑林鈉（皮下製劑））


BJ009被設計為一種創新的頭孢唑林鈉（第一代頭孢菌素類抗生素）皮下
製劑，其透過抑制細菌細胞壁的合成而發揮作用，最終致使細胞裂解。
與靜脈注射用頭孢唑林鈉相似，BJ009 有潛力治療由細菌引發的多種感
染，包括皮膚、骨骼、關節、生殖器、血液、心臟瓣膜、呼吸道、膽道
及尿路感染。再者，BJ009 採用皮下給藥的方式，能帶來增強的治療體
驗，降低併發症風險，同時減少治療成本，這顯示出其市場潛力。



我們於2025年5月提交BJ009的IND申請，並於2025年9月獲得國家藥監
局的IND批准。獲批後，我們於2025 年12 月開展BJ009 的I期臨床試驗
(CTR20255246)。我們計劃繼續推進BJ009的I期臨床試驗。

SJ04（重組人絨促性素）


SJ04 是一種重組人絨促性素(hCG)，可用於輔助生殖手術，以加速卵泡
成熟及促排卵。此外，SJ04適用於治療青春期前隱睾症、男性低促性腺
激素性性腺功能減退症、黃體功能不足及功能性子宮出血。對於女性，
SJ04可促進卵泡成熟及激發排卵，同時促使卵泡破裂形成功能性黃體，
以促進黃體酮的分泌。因此，SJ04 可促進黃體功能不足人士的子宮內
膜發育，改善生殖預後，並通過使功能性子宮出血人士的激素模式正常
化，有助建立規律的月經週期。



於2024 年5 月，我們獲得國家藥監局對SJ04 的IND批准。隨後，我們於
2024年8月在中國開展SJ04的I期臨床試驗，並於2025年8月完成患者入
組。我們於2025年9月完成I期臨床試驗。隨著近期生物類似藥的監管發
展，我們正在就後續的臨床開發計劃與相關監管機構進行溝通。
22

根據上市規則第18A.08(3)條發出的警告：概不保證本公司最終將能夠成功開發及
銷售KJ101、BJ044、KJ015、BJ045、BJ047、BJ007、BJ008、BJ009及SJ04。
我們的專有技術平台
憑藉我們在合成生物技術方面的優勢，我們有預見性地建立全面一體化內部研發
及生產能力。迄今為止，我們運營三個技術平台，涵蓋藥物設計、底盤細胞打造
及完整的生物製造，使我們能夠駕馭複雜的過程，將我們的轉化型重組蛋白藥物
從實驗室推向臨床。具體而言，我們的三個技術平台包括：
•

藥物設計平台：我們的藥物設計方法聚焦於開發符合藥物獨特性及目標患者
群體特定需求的定制化給藥系統及製劑。我們在藥物開發中優先考慮免疫原
性、分子穩定性和具成本效益的生產。我們利用AI驅動的模型，將先進的計
算模擬與嚴格的實驗驗證相結合，以實現精確的蛋白質工程和功能優化。濕
法實驗產生的數據不斷反饋到我們的模型中，以細化和增強其性能，從而促
成一個迭代和適應性的設計過程。因此，作為我們核心產品之一的KJ103 從
我們的藥物設計平台中誕生，為一種由複雜酶組成、具備卓越穩定性及功能
性的候選藥物，充分展現該平台的轉化能力。

•

底盤細胞打造平台：我們的底盤細胞打造平台專注於糖基化修飾及先進的表
達技術。憑藉在酶工程、糖工程及合成生物學方面的廣泛專業知識，我們已
在多個領域取得關鍵突破，如重組人玻璃酸酶的蛋白質翻譯調控及翻譯後修
飾、中國倉鼠卵巢(CHO)細胞糖基化工程及蛋白質高表達技術。
我們在三種主要生物製藥宿主系統（包括大腸桿菌、畢赤酵母及CHO細胞系
統）中採用多學科方法，以設計生物元件、工程化代謝途徑及篩選來自修飾
宿主的藥物蛋白。此方法使我們能夠根據特定藥物蛋白的結構及功能需求，
在最合適的宿主中表達蛋白質，從而大大縮短新療法的開發週期。
尤其是，我們已開發出一個含有工程化糖基轉移酶的CHO細胞庫，以生成結
構均一性更佳的人源化糖蛋白。這顯著降低免疫原性，延長半衰期，並提高
療效。此外，我們的畢赤酵母細胞庫具有表達伴侶及經優化的宿主，可立即
用於新項目工藝研究，從而簡化我們的藥物生產及加快項目時間表。

•

完整的生物製造平台：我們的完整的生物製造平台整合了哺乳動物、酵母及
大腸桿菌表達系統，以支持我們重組蛋白藥物的大規模、高效及可持續生
產。我們優化生產流程及設備，注重環境可持續性。透過整合高產量的菌株
或細胞、優化的培養工藝及先進的純化技術，我們實現了具有綠色製造優勢
的規模化製造能力。
23

此平台可應對關鍵技術挑戰，包括但不限於：(i)通過合成生物學及基因工程
增強重組蛋白表達及解決發酵過程中的蛋白降解，從而為高效重組蛋白生產
提供上游解決方案；(ii)採用不同的發酵策略來克服毒性副產物積累、蛋白質
錯誤折疊及細胞快速生長過程中活性低等問題，從而使用高密度合成生物學
技術實現靶蛋白的穩定、高效表達；(iii)結合不同的色譜分離技術，利用定
制樹脂開發可擴展且具有成本效益的高純度重組蛋白製備工藝；及(iv)提高體
積生產力並開發資源節約型、低能耗的綠色製造解決方案，以滿足商業規模
生產重組蛋白的需求。
除我們的專有平台技術外，我們還擁有商業規模的製造能力以及嚴格的質量
控制及保證體系，使我們能夠有效地擴大生產，以滿足候選藥物商業化後不
斷增長的需求，同時確保卓越的質量及成本效益。

業務前景
於2026年上半年，我們穩步推進核心戰略，利用合成生物技術研發底盤細胞，並
開發及生產傳統基因工程難以表達的重組生物藥物，在研發創新、臨床推進及產
業佈局方面實現多項重要里程碑。於2026年餘下期間，我們將進一步深化合成生
物學研發運作機制改革，聚焦重組生物製品的核心優勢，持續提升研發效率，加
強外部戰略合作，加強科學決策，並在大容量皮下給藥、抗體介導的自身免疫性
疾病、輔助生殖及重組生物製品四大戰略領域鞏固和擴大我們的領先地位。我們
將繼續以市場及臨床價值為導向，圍繞高需求醫療領域持續開發具明確差異化及
全球潛力的創新藥物。以底盤細胞構建平台為核心並整合藥物設計平台及端到端
生物製造平台，我們將持續強化核心技術能力，提升創新藥物研發的成功率。同
時，我們將積極拓展全球合作，加快培育新的競爭優勢，並全面釋放我們產品管
線的全球價值。
具體而言，我們計劃推行以下策略：(i)加快核心治療領域管線的開發，全面釋放
臨床及商業價值；(ii)提升商業規模製造能力及質量管理體系，穩步推進商業化；
(iii)拓展全球佈局，深化戰略合作夥伴關係，實現產品管線的全球價值；及(iv)吸
引、發展及保留高素質人才，優化營運體系，致力成為運用合成生物學開發重組
生物製劑的全球領導者。

24

加快核心治療領域管線的開發，全面釋放臨床及商業價值
於2026年，我們的主要目標是繼續推進多元化的臨床產品組合，推動於2026年3
月獲批的KJ017商業化，並提高SJ02的市場佔有率。我們將加快開發及註冊四大
戰略領域的核心管線和其他臨床及臨床前候選藥物，同時落實KJ017和SJ02的商
業化計劃，以最大限度提高患者可及性並創造可持續價值。具體而言：
•

大容量皮下給藥：我們專注於以重組人玻璃酸酶作為皮下給藥平台的核心支
柱。於2026年3月，我們的核心產品KJ017（規格為385U╱ 瓶）已獲國家藥監
局批准上市，用於輔助皮下輸液（氯化鈉注射液和乳酸鈉林格注射液等），且
我們將繼續推進該產品於中國的商業化。與此同時，我們正推進「雙抗」戰
略，開發抗體藥物及化學藥物的皮下製劑。我們自主研發的創新抗HER2 雙
特異性抗體KJ015預計將於2026年下半年完成於國內的I期臨床試驗。於2026
年8 月，我們從FDA獲得了KJ015 的IND批准，獲准開展臨床試驗。除深化
與抗體開發商合作，推動更多皮下抗體項目進入後期臨床開發外，我們亦將
加快皮下抗生素的臨床開發。於2026年1月，BJ007已完成於國內的I期臨床
試驗，並預期於2026 年下半年進入關鍵臨床試驗。於2026 年5 月，BJ007 的
IND申請獲得FDA批准，獲准開展臨床試驗。我們預期於2026年下半年開展
BJ007的海外臨床試驗。

•

抗體介導的自身免疫性疾病：為應對多種抗體介導的自身免疫性疾病的未被
滿足需求，我們將致力推進核心產品KJ103的開發。KJ103用於高度致敏腎臟
移植患者脫敏治療的NDA於2026 年5 月獲納入優先審評程序，並於2026 年6
月獲國家藥監局受理。我們預計於2027年獲得NDA批准。於2026年下半年，
我們預計開展KJ103用於抗GBM病的III期臨床試驗，並完成GBS II期臨床試
驗的患者入組。同時，我們將把與抗酶切重組抗體的聯合療法（如BJ045 及
BJ047）推進至臨床階段，並積極探索KJ103在異種移植等新興領域的潛力。
在器官衰竭病例日益增加及器官持續短缺的背景下，異種移植已於全球取得
顯著技術進展。我們的研究產品旨在協助克服免疫排斥反應，此乃該領域取
得成功的關鍵決定因素之一。憑藉我們在酶技術及抗體工程方面的專業能
力，我們有信心可在此不斷增長的市場中佔據重要份額，推進異種移植科學
的發展，並滿足巨大的未滿足醫療需求缺口。

•

輔助生殖：於2025年8月，SJ02（晟諾娃 ®）在中國獲得上市批准，可降低接受
ART的女性每日注射短效FSH造成的治療負擔。SJ02為一種長效FSH-CTP，
單次注射可替代短效FSH連續七天注射，可顯著改善現行護理模式。展望未
來，我們將與商業化合作夥伴安科生物緊密合作，全面進行SJ02（晟諾娃 ®）
在中國的商業化工作，並實現其臨床價值。

25

•

重組生物製品：我們運用合成生物學技術，通過打造高效底盤細胞生產傳統
生化提取難以製造的複雜蛋白質，開發創新重組生物製劑，從而解決低效、
雜質及安全性風險，包括過敏及未知病毒污染。隨著II期臨床試驗於2026年
6月完成，我們將繼續推進KJ101用於燒傷、創傷、手術切口、壓瘡及糖尿病
足潰瘍等傷口癒合適應症的臨床開發。對於用於胃鏡檢查時溶解去除胃內黏
液的適應症，KJ101於2026年3月獲國家藥監局批准進行臨床試驗，且我們預
計於2026年下半年完成I期臨床試驗。BJ044的IND申請於2026年6月獲國家
藥監局批准，且我們預計於2026年下半年開展I期臨床試驗。

提升商業規模製造能力及質量管理，穩步推進商業化
我們已於上海建立符合GMP標準的生產基地，佔地面積約63,000平方米。為進一
步提升商業化產能，我們正在上海興建一處新基地，佔地面積約37,000平方米，
預計將於2026年竣工並投入使用。我們現有的生產基地配備專為生產複雜生物製
品而設計的生產線，具備生產重組蛋白藥物的專業能力，可滿足核心產品SJ02、
KJ017及KJ103的生產需求，同時支持「合成生物升級替代生化提取」戰略下的創
新產品開發，包括重組人糜蛋白酶KJ101（II期）及重組烏司他丁BJ044（IND獲
批）。該等舉措響應上海市推動將科技創新優勢轉化為高質量製造業產出的倡議，
亦與寶山北上海生物醫藥產業園以「合成生物產業化」為重點的戰略定位相契合，
深入貫徹「促進生物醫藥產業高質量發展」的政策方針。
隨著SJ02 於2025 年8 月獲批及KJ017 於2026 年3 月獲批，我們的生產重心正從單
一的臨床供應轉向臨床與商業化生產的雙軌模式。我們將繼續提升生產基地的運
營效率，對標國際標準，並進一步完善我們的綜合質量管理體系，以確保產品質
量、安全性及療效始終如一地符合監管要求，保障患者用藥安全。
拓展全球佈局，深化戰略合作夥伴關係，完全實現管線的全球價值
依託於現有授權及合作（包括藥明生物、上海萊士、安科生物、荃信生物、尚健
等）的成功往績，我們將繼續在全球範圍內積極尋求新的合作機會。我們的戰略
包括：(i)優先推進中國市場的產品開發及商業化，建立先發優勢；(ii)通過國內產
品銷售及多元化合作產生穩定收入，以支持持續的研發與商業化投資；及(iii)在
國內取得商業化成功後，進一步拓展適應症，並進軍主要海外市場。對於早期資
產及平台技術，我們亦將尋求與全球領先的生物技術公司及研究機構開展聯合開
發或授權引進 ╱ 轉出合作，以探索新的治療領域及前沿模式，並強化平台能力。
我們旨在通過靈活的合作模式令創新成果惠及全球更多病患，並實現產品管線價
值的最大化。

26

吸引、發展及保留高素質人才，優化營運體系
我們將繼續推行全面的人才策略，積極招募在研發、商業化、管理及全球業務發
展等領域具備深厚專業知識與豐富經驗的頂尖專業人才，以支持我們的快速發展
與國際化發展。同時，我們將不斷優化內部管理流程，特別是提高研發項目管理
及跨部門協作效率，確保能靈活應對市場變化及有效推進管線資產。
於2026年餘下期間，隨著業務拓展及新產品陸續上市，我們將繼續秉持「急患者
之需而行」的公司使命，聚焦尚未滿足的醫療需求領域，持續開發可及性高、惠
及面廣的藥物。我們致力於成長為具有全球影響力的合成生物與重組生物製品領
導者。
根據上市規則第18A.08(3)條發出的警告：概不保證最終將能成功開發及銷售核心
產品及其他候選藥物。

獎項及表彰
2026 年4 月，經上海市總工會推薦，本公司在全國表彰大會上獲頒全國五一勞動
獎狀，是上海市獲得該獎項的25家企業之一。

財務回顧
收入
截至6月30日止六個月
2026年
2025年
（未經審計） （經審計）
人民幣千元 人民幣千元
銷售材料
技術服務
許可收入

1,170
8,705
–

983
1,005
40,002

總計

9,875

41,990

我們的收入由截至2025 年6 月30 日止六個月的人民幣42.0 百萬元減少人民幣32.1
百萬元或76.5%至截至2026年6月30日止六個月的人民幣9.9百萬元，主要由於沒
有發生在相應期間確認的一次性許可收入人民幣40.0百萬元，部分被技術服務收
入增加人民幣7.7百萬元及銷售材料增加人民幣0.2百萬元所抵銷。

27

銷售成本
於報告期間，我們的銷售成本主要包括原物料成本、員工成本及相關的折舊及攤
銷開支。我們的銷售成本由截至2025年6月30日止六個月的人民幣0.3百萬元增加
至截至2026年6月30日止六個月的人民幣0.5百萬元。
其他收入及收益
截至6月30日止六個月
2026年
2025年
（未經審計） （經審計）
人民幣千元 人民幣千元
其他收入
政府補助*
銀行利息收入
其他
收益
因於一家聯營公司的投資被動稀釋導致的變動
處置使用權資產的收益
總計
*

2,648
9,465
61

1,894
3,591
414

75
5

–
–

12,254

5,899

政府補助乃從中國地方政府部門收取，以支持本集團的研發及其他經營活動。該等政府補
助並無未達成的條件。於2026年6月30日，已收到但尚未滿足收入確認條件的與資產相關
政府補助金額為人民幣114.7百萬元。

我們的其他收入及收益由截至2025年6月30日止六個月的人民幣5.9百萬元增加人
民幣6.4百萬元或107.7%至截至2026年6月30日止六個月的人民幣12.3百萬元，主
要由於銀行利息收入增加人民幣5.9百萬元及政府補助增加人民幣0.8百萬元。

28

行政開支
截至6月30日止六個月
2026年
2025年
（未經審計） （經審計）
人民幣千元 人民幣千元
員工成本
折舊及攤銷開支
以股份為基礎的付款
稅項及附加費
專業服務費
一般辦公室開支
其他

15,449
9,128
4,601
2,787
2,750
1,890
4,011

13,169
4,748
17,732
991
2,622
3,827
3,064

總計

40,616

46,153

我們的行政開支由截至2025年6月30日止六個月的人民幣46.2百萬元減少人民幣
5.5百萬元或12.0%至截至2026年6月30日止六個月的人民幣40.6百萬元，主要由
於我們向管理層及行政人員授予股份激勵而產生以股份為基礎的付款減少。
研發開支
截至6月30日止六個月
2026年
2025年
（未經審計） （經審計）
人民幣千元 人民幣千元
試驗及測試費用
員工成本
折舊及攤銷開支
以股份為基礎的付款
原物料成本
其他

33,710
29,259
11,560
7,558
5,029
5,454

19,881
36,231
12,166
27,636
7,517
7,614

總計

92,570

111,045

我們的研發開支由截至2025年6月30日止六個月的人民幣111.0百萬元減少人民幣
18.5百萬元或16.6%至截至2026年6月30日止六個月的人民幣92.6百萬元。減少主
要由於與向我們的研發人員授出股份激勵相關的以股份為基礎的付款開支減少人
民幣20.1百萬元，部分被隨著我們推進候選藥物的持續臨床開發，試驗及測試費
用增加人民幣13.8百萬元所抵銷。
29

其他開支
我們的其他開支由截至2025年6月30日止六個月的人民幣55.4百萬元減少人民幣
20.0百萬元或36.2%至截至2026年6月30日止六個月的人民幣35.3百萬元，主要由
於在報告期間，我們並無確認額外的訴訟虧損撥備，部分被外匯虧損淨額增加人
民幣35.0百萬元所抵銷。
應佔一家聯營公司虧損
於報告期間，我們應佔一家聯營公司虧損指投資君聯生物技術的虧損。截至
2025年及2026年6月30日止六個月，我們分別確認應佔一家聯營公司虧損人民幣
114,000元及人民幣54,000元，乃由於君聯生物技術於同期產生的淨虧損。
預付款項、其他應收款項及其他資產
2026年
2025年
6月30日
12月31日
（未經審計） （經審計）
人民幣千元 人民幣千元
非流動：
物業、廠房及設備預付款項

26,624

97,062

流動：
預付款項
押金及其他應收款項
可抵扣增值稅
預付開支

5,332
2,124
46,577
511

3,513
1,333
21,904
837

總計

54,544

27,587

30

資本結構、流動資金及財務資源
截至2026年6月30日，本集團的現金及現金等價物為人民幣1,042.1百萬元，而截
至2025年12月31日則為人民幣1,241.6百萬元。截至2026年6月30日，本集團的現
金及銀行結餘主要以人民幣、港元及美元計值。
本集團的現金頭寸減少，主要由於經營活動所用現金淨額人民幣146.6百萬元及投
資活動所用現金淨額人民幣116.2 百萬元，部分被融資活動所得現金淨額人民幣
99.2百萬元所抵銷。
截至2026年6月30日，本集團的流動資產為人民幣1,212.2百萬元（截至2025年12
月31日：人民幣1,363.2百萬元），主要包括現金及現金等價物人民幣1,042.1百萬
元、受限制存款人民幣91.9百萬元、預付款項、其他應收款項及其他資產人民幣
54.5百萬元、存貨人民幣16.8百萬元及貿易應收款項人民幣6.9百萬元。
截至2026年6月30日，本集團的流動負債為人民幣314.7百萬元（截至2025年12月
31日：人民幣330.7百萬元），主要包括其他應付款項及應計費用人民幣175.6百萬
元、計息銀行借款人民幣134.1百萬元、遞延收益人民幣3.6百萬元、租賃負債人
民幣1.1百萬元及貿易應付款項人民幣0.3百萬元。
截至2026年6月30日，本集團維持穩健流動資金狀況。本集團監察並維持管理層
認為足以撥付營運資金並緩解現金流量波動影響的現金及現金等價物水平。於報
告期間，我們主要通過現有現金及現金等價物以及銀行借款滿足營運資金需求。
本集團預期將透過多種資金來源組合來滿足營運資金及其他資本需求，包括但不
限於按合理市場利率進行的外部融資。為更有效地控制資金成本並將其降至最
低，本集團的財務活動實行集中化管理，所有現金交易均透過信譽良好的銀行進
行。
資產負債比率
本集團使用資產負債比率監察資金情況，計算方法為總債務除以總資產。總債務
包括流動負債及非流動負債。
截至2026年6月30日，本集團的資產負債比率為33.23%，而截至2025年12月31日
則為28.19%。

31

債務
截至2026年6月30日，本集團的計息銀行借款為人民幣421.6百萬元，而截至2025
年12月31日則為人民幣312.4百萬元。該等借款中，人民幣134.1百萬元於一年內
償還，而人民幣287.5百萬元超過一年以上償還。
截至2026年6月30日，本集團的租賃負債為人民幣1.6百萬元，而截至2025年12月
31日則為人民幣2.6百萬元。該變動主要由於在報告期間作出租賃付款。
資本承擔
截至2026年6月30日，本集團的資本承擔為人民幣132.5百萬元（截至2025年12月
31日：人民幣174.5百萬元）。該等資本承擔主要與購置及興建物業、廠房及設備
有關。
或然負債
截至2026年6月30日，本集團並無任何或然負債。
資產抵押
截至 2026 年 6 月 30 日，本集團的部分銀行借款以本集團賬面值分別為約人民幣
562.4百萬元（截至2025年12月31日：人民幣539.8百萬元）及約人民幣50.2百萬元
（截至2025年12月31日：人民幣50.8百萬元）的物業、廠房及設備及租賃土地作抵
押。
外匯風險
本集團面臨主要來自本公司功能貨幣以外的貨幣計值的現金及現金等價物引起的
交易貨幣風險，以港元及美元為主。
本集團目前並未使用任何金融工具或簽訂任何外匯合約以對沖外匯風險。然而，
管理層密切監察外匯風險，並將在必要時考慮對沖重大外匯風險。

僱員及薪酬政策
截至2026年6月30日，本集團共有364名全職僱員。我們僱員收取的酬金包括基本
薪金、酌情花紅及福利，一般參考其資歷、行業經驗、職位及表現釐定。我們根
據中國法律法規為僱員繳納社會保險及住房公積金。此外，我們為僱員提供相關
培訓以提升其技能及知識。我們亦已實施員工激勵計劃，以認可及獎勵僱員的貢
獻。
32

重大投資、收購及出售事項
於報告期間，本集團並無任何重大投資或重大收購或出售附屬公司、聯營公司及
合營企業。
截至本公告日期，本集團並無任何重大投資或資本資產的未來計劃。倘落實任何
投資及收購機會，本集團將根據上市規則作出進一步公告（如適用）。

報告期後事項
截至本公告日期，除本公告所披露者外，於報告期後概無重大後續事項。

中期股息
董事會決議不建議派發截至2026年6月30日止六個月的中期股息（截至2025年6月
30日止六個月：零）。

企業管治及其他資料
遵守企業管治守則
本公司致力於實現高標準的企業管治，以保障股東的利益，並提升企業價值與問
責性。本公司已採納上市規則附錄C1所載企業管治守則作為其自身的企業管治守
則。於報告期間，董事會認為，本公司已遵守企業管治守則第2 部所載所有適用
守則條文。為維持高標準的企業管治，董事會將持續檢討及監察本公司營運。
於2026年5月26日舉行的股東週年大會上，股東批准（其中包括）取消監事會及選
舉第二屆董事會。監事會取消後，審核委員會根據經修訂組織章程細則承接監事
會過往行使的職權。
遵守標準守則
本公司已採納有關董事、前任監事及僱員進行證券交易的行為守則，其條款不遜
於標準守則所載的規定標準。
經向全體董事及前任監事作出具體查詢後，彼等各自確認，其於截至2026年6 月
30日止六個月內的任期內已遵守本公司有關董事、前任監事及僱員進行證券交易
的行為守則。截至2026年6月30日止六個月，本公司並無發現任何可能掌握本公
司內幕消息的僱員違反標準守則的事件。
33

董事及主要行政人員資料變動
下文載列根據上市規則第13.51B(1)條規定須予披露的董事及本公司主要行政人員
資料變動：
(1) 獨立非執行董事張森泉先生獲委任為運鴻硅鑫集團控股有限公司（香港聯交
所：8349）的公司秘書及授權代表，自2026年3月9日起生效；
(2) 於本公司在2026年5月26日舉行的股東週年大會上，第二屆董事會獨立非執
行董事的標準薪酬獲批，為每年人民幣240,000元（稅前）
（相比重選前則為每
年人民幣150,000元（稅前）），按季度等額支付。
除上文所披露者外，截至本公告日期，概無其他根據上市規則第13.51B(1)條須予
披露的董事及本公司主要行政人員的資料變動。
聯席公司秘書、授權代表及法律程序代理人變動
方希琳女士（「方女士」）已辭任(i)本公司聯席公司秘書（「聯席公司秘書」）；(ii)聯
交所上市規則第3.05條所規定的本公司授權代表（「授權代表」）；及(iii)上市規則
第19.05(2)條及香港法例第622章公司條例第16部所規定在香港代表本公司接收法
律程序文件及通知書的代表（「法律程序代理人」），自2026年7月8日起生效。在方
女士辭任後，曾俊豪先生（「曾先生」）已獲委任為聯席公司秘書、授權代表兼法律
程序代理人，自2026年7月8日起生效。在曾先生獲委任後，本公司聯席公司秘書
為李翠女士及曾先生，而本公司授權代表為劉彥君博士及曾先生。有關進一步詳
情，請參閱本公司日期為2026年7月8日的公告。

34

購買、出售或贖回本公司上市證券
於報告期間，本公司於聯交所購回合共95,200 股H股，總對價約為1.7 百萬港元
（不含交易費）。所有該等已購回H股均作為庫存股持有。除上文所披露者外，於
報告期間，本公司及其任何附屬公司概無購買、出售或贖回本公司任何上市證券
（包括出售任何庫存股）。截至2026年6月30日，本公司持有95,200股庫存股。
購回詳情載列如下：
每股股份價格
報告期間的購回月份

購回股份
數目

2026年6月

95,200

總計

95,200

最高價
（港元）

最低價
（港元）

已付對價
總額
（港元）

17.81

17.38

1,686,277.6
1,686,277.6

所得款項用途
隨著本公司股份於2025年12月10日在聯交所上市，經扣除我們就全球發售應付的
包銷費用及佣金以及估計開支，全球發售所得款項淨額約為921.5百萬港元，該等
款項已經並將用於招股章程所載用途。
截至本公告日期，招股章程「未來計劃及所得款項用途」一節先前披露的所得款項
淨額的擬定用途並無變動。倘全球發售所得款項淨額未能即時用作上述用途，我
們僅會將未動用的所得款項淨額存入持牌商業銀行及 ╱ 或其他認可金融機構（定
義見證券及期貨條例或其他司法權區的適用法律法規）的短期計息賬戶。
下表載列所得款項淨額的計劃用途、截至2025年12月31日的未動用金額、報告期
間已動用金額、截至2026年6月30日的已動用金額，以及截至2026 年6月30日的
未動用金額。本表中總額與各項金額總和之間的任何差異均由四捨五入所致。

35

所得款項淨額擬定用途

所得
款項淨額
分配
百萬港元

佔所得
於2025年
於2026年
於2026年
款項淨額 12月31日
6月30日
6月30日
總額 未動用所得
報告期間 已動用所得 未動用所得
百分比
款項淨額 已動用金額
款項淨額
款項淨額
百萬港元
百萬港元
百萬港元
百萬港元

用於核心產品（包括KJ017、KJ103及SJ02）
的研發及商業化

493.2

53.5%

489.8

42.0

45.4

447.8

用於推進其他現有管線產品及籌備相關登記
備案

162.8

17.7%

155.7

15.4

22.5

140.3

用於持續優化本集團專有合成生物學技術
平台，以及研究和開發新候選藥物

77.4

8.4%

75.3

30.5

32.6

44.8

用於提升及擴大生產能力

95.9

10.4%

69.0

44.7

71.6

24.3

用作營運資金及一般公司用途

92.2

10.0%

90.0

9.3

11.5

80.7

總計

921.5

100.0%

879.8

141.9

183.6

737.9

未動用全球發售所得款項淨額預期於2028年12月31日前悉數動用。

36

審核委員會
本公司已設立審核委員會，其書面職權範圍符合上市規則第3.21條及企業管治守
則，且有關內容已刊載於香港聯交所網站。審核委員會的主要職責是檢討及監督
本集團的財務報告程序及內部控制系統，並向董事會提供意見及建議。截至本公
告日期，審核委員會由兩名獨立非執行董事及一名非執行董事組成，即張森泉先
生（「張先生」）、鞠佃文博士及刁雋桓先生，並由張先生擔任主席。張先生具備上
市規則第3.10(2)條及第3.21條規定的適當專業經驗。
審核委員會已與本公司管理層審閱本集團採納的會計原則及政策，並討論內部控
制及財務報告事宜，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
明綜合中期財務資料及中期業績。
本集團截至2026年6月30日止六個月的未經審計中期簡明綜合財務資料，已由安
永會計師事務所根據香港會計師公會頒佈的香港審閱準則第2410號實體的獨立核
數師對中期財務資料的審閱 進行審閱。

致謝
本人謹代表董事會就股東及業務夥伴的持續信任及支持，以及僱員的勤勉、奉
獻、忠誠及誠信向彼等致以衷心感謝。

37

中期簡明綜合損益表

截至2026年6月30日止六個月
（未經審計，以人民幣計）
截至6月30日止六個月
附註
2026年
2025年
（未經審計） （經審計）
人民幣千元 人民幣千元
收入

9,875

41,990

銷售成本

(537)

(265)

毛利

9,338

41,725

12,254
(92,570)
(3,610)
(40,616)
–
(3,088)
(35,339)
(54)

5,899
(111,045)
(2,942)
(46,153)
(12,435)
(2,666)
(55,365)
(114)

(153,685)

(183,096)

–

–

期內虧損

(153,685)

(183,096)

以下人士應佔：
母公司擁有人

(153,685)

(183,096)

(0.47)

(0.64)

4

其他收入及收益
研發開支
業務發展開支
行政開支
上市開支
融資成本
其他開支
應佔一家聯營公司虧損

4

除稅前虧損
所得稅抵免

5

母公司普通權益持有人應佔每股虧損

7

基本及攤薄（人民幣）

38

中期簡明綜合全面收益表

截至2026年6月30日止六個月
（未經審計，以人民幣計）
截至6月30日止六個月
2026年
2025年
（未經審計） （經審計）
人民幣千元 人民幣千元
期內虧損

(153,685)

(183,096)

於後續期間可能重新分類至損益的其他全面虧損：
換算海外業務產生的匯兌差額

(542)

–

期內其他全面虧損（扣除稅項）

(542)

–

期內全面虧損總額

(154,227)

(183,096)

以下人士應佔：
母公司擁有人

(154,227)

(183,096)

其他全面虧損

39

中期簡明綜合財務狀況表

於2026年6月30日
（以人民幣計）

附註

非流動資產
物業、廠房及設備
使用權資產
其他無形資產
於一家聯營公司的投資
預付款項、其他應收款項及其他資產

2026年
2025年
6月30日
12月31日
（未經審計） （經審計）
人民幣千元 人民幣千元
857,276
51,906
10,951
10,835
26,624

680,696
53,561
11,690
10,814
97,062

957,592

853,823

16,780
6,906
54,544
91,917
1,042,096

6,248
98
27,587
87,614
1,241,609

1,212,243

1,363,156

304
175,637
134,083
3,621
1,079

8
210,492
113,958
4,587
1,607

流動負債總額

314,724

330,652

流動資產淨額

897,519

1,032,504

1,855,111

1,886,327

非流動負債
計息銀行借款
租賃負債
遞延收益

287,481
524
118,382

198,451
979
94,923

非流動負債總額

406,387

294,353

淨資產

1,448,724

1,591,974

權益
母公司擁有人應佔權益
股本
庫存股
儲備

65,196
(1,468)
1,384,996

65,196
–
1,526,778

總權益

1,448,724

1,591,974

8

非流動資產總額
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
受限制存款
現金及現金等價物

9
8

流動資產總額
流動負債
貿易應付款項
其他應付款項及應計費用
計息銀行借款
遞延收益
租賃負債

10
11

總資產減流動負債

40

中期簡明綜合現金流量表

截至2026年6月30日止六個月
（未經審計，以人民幣計）

附註

經營活動所用現金流量
除稅前虧損
就以下各項作出調整：
利息收入
融資成本
以權益結算並以股份為基礎的付款開支
匯兌差額淨額
物業、廠房及設備折舊
使用權資產折舊
其他無形資產攤銷
因於一家聯營公司的投資被動稀釋導致的變動
處置使用權資產的收益
處置物業、廠房及設備項目的虧損
應佔一家聯營公司虧損

截至6月30日止六個月
2026年
2025年
（未經審計） （經審計）
人民幣千元 人民幣千元
(153,685)

(183,096)

(9,465)
3,088
12,445
35,329
17,518
1,441
1,251
(75)
(5)
–
54

(3,591)
2,666
46,805
282
15,099
851
1,044
–
–
3
114

(92,104)

(119,823)

貿易應收款項（增加）╱ 減少
預付款項、其他應收款項及其他資產增加
存貨增加
遞延收益（減少）╱ 增加
貿易應付款項增加
其他應付款項及應計費用（減少）╱ 增加
受限制存款減少 ╱（增加）

(6,808)
(26,957)
(7,714)
(940)
296
(21,925)
65

22
(7,093)
(647)
200
–
18,644
(84)

經營所用現金
已收利息

(156,087)
9,465

(108,781)
3,591

經營活動所用現金流量淨額

(146,622)

(105,190)

投資活動所用現金流量
購買物業、廠房及設備項目
（存放）╱ 提取受限制存款
處置物業、廠房及設備項目所得款項
就物業、廠房及設備收取政府補助

(135,245)
(4,368)
4
23,433

(37,891)
5,000
371
2,700

投資活動所用現金流量淨額

(116,176)

(29,820)

41

4

4
4

中期簡明綜合現金流量表

截至2026年6月30日止六個月
（未經審計，以人民幣計）
截至6月30日止六個月
附註
2026年
2025年
（未經審計） （經審計）
人民幣千元 人民幣千元
融資活動現金流量
發行股份所得款項
新增計息銀行借款
償還計息銀行借款
租賃付款本金部分
已付利息
購回普通股
支付上市開支

–
163,382
(54,268)
(764)
(4,986)
(1,468)
(2,740)

30,000
87,291
(45,750)
(836)
(3,582)
–
(2,597)

融資活動所得現金流量淨額

99,156

64,526

現金及現金等價物淨減少
期初現金及現金等價物
外匯匯率變動的影響淨值

(163,642)
1,241,609
(35,871)

(70,484)
524,158
(282)

期末現金及現金等價物

1,042,096

453,392

42

中期簡明綜合財務資料附註
1.

公司及集團資料
本公司於2019年12月16日根據中國公司法在中華人民共和國（「中國」）成立為一家有限責
任公司。本公司的註冊辦事處位於上海市寶山區羅新路28號。本公司於2023年7月26日改
制為股份有限公司。
期內，本公司及其附屬公司從事藥品研發及商業化。
本公司的股份在香港聯合交易所有限公司（「聯交所」）主板上市，自2025年12月10日起生
效。

2.1 編製基準
截至2026年6月30日止六個月中期簡明綜合財務資料已根據國際會計準則第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所需的全部資料及披露，並應與
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。

2.2 會計政策的變動及披露
編製中期簡明綜合財務資料所採納的會計政策與本集團編製截至2025年12月31日止年度
的年度綜合財務報表所應用者一致，惟於本期間財務資料首次採納以下經修訂國際財務報
告準則會計準則除外。

金融工具的分類及計量的修訂

國際財務報告準則第9號及
國際財務報告準則第7號的修訂
國際財務報告準則第9號及
國際財務報告準則第7號的修訂
國際財務報告準則會計準則的
年度改進 － 第11卷

3.

涉及依賴自然能源生產電力的合約
國際財務報告準則第1號、國際財務報告
準則第7號、國際財務報告準則第9號、
國際財務報告準則第10號及國際會計
準則第7號的修訂

經營分部資料
經營分部資料
就管理目的而言，本集團僅有一個可報告經營分部，即藥品研發及商業化。由於此乃本集
團唯一可報告經營分部，故並無呈列其進一步經營分部分析。
地理信息
於報告期間，本集團幾乎所有收入來自位於中國內地的客戶，且本集團所有非流動資產均
位於中國內地，因此並無地理分部信息按照國際財務報告準則第8號經營分部 進行列報。

43

4.

收入、其他收入及收益
收入分析如下：
截至2026年
6月30日
止六個月
（未經審計）
人民幣千元

截至2025年
6月30日
止六個月
（經審計）
人民幣千元

9,875

41,990

截至2026年
6月30日
止六個月
（未經審計）
人民幣千元

截至2025年
6月30日
止六個月
（經審計）
人民幣千元

貨品及服務類型
銷售材料
技術服務
許可收入

1,170
8,705
–

983
1,005
40,002

總計

9,875

41,990

收入確認的時間
在某一時間點轉移貨品
在某一時間點轉移服務

1,170
8,705

983
41,007

總計

9,875

41,990

客戶合約收入

分類收入資料

下表顯示於各報告期間確認的收入金額，該等收入於各報告期間初已計入合約負債，並已
於過往期間履行的履約責任中確認：

客戶合約收入
44

截至2026年
6月30日
止六個月
（未經審計）
人民幣千元

截至2025年
6月30日
止六個月
（經審計）
人民幣千元

–

40,011

其他收入及收益的分析如下：
截至2026年
6月30日
止六個月
（未經審計）
人民幣千元

截至2025年
6月30日
止六個月
（經審計）
人民幣千元

其他收入
政府補助*
銀行利息收入
其他

2,648
9,465
61

1,894
3,591
414

其他收入總額

12,174

5,899

收益
因於一家聯營公司的投資被動稀釋導致的變動
處置使用權資產的收益

75
5

–
–

收益總額

80

–

12,254

5,899

其他收入及收益總額
*

政府補助乃從中國地方政府部門收取，以支持本集團的經營活動。該等政府補助並
無未達成的條件。

45

5.

所得稅
中國內地
根據《中華人民共和國企業所得稅法》及相關法規，海南寶濟生物科技有限公司於報告期
間的應課稅收入須按25%的稅率繳納企業所得稅。2025年至2027年，上海寶濟藥業股份有
限公司、蘇州晟濟藥業有限公司及蘇州康聚生物科技有限公司作為合資格高新技術企業，
享有15%的企業所得稅優惠稅率。
香港
於香港註冊成立的附屬公司及登記為香港稅務居民的附屬公司，須就報告期間在香港產生
的估計應課稅溢利按16.5%的稅率繳納所得稅。該附屬公司首2,000,000港元的應課稅溢利
按8.25%徵稅，剩餘應課稅溢利則按16.5%徵稅。
截至 2026 年 6 月 30 日止六個月，概無計提所得稅撥備（截至 2025 年 6 月 30 日止六個月：
零），此乃由於本集團的經營實體並未產生應課稅溢利。

6.

股息
截至2026年6月30日止六個月，本公司並無派付或宣派任何股息（截至2025年6月30日止
六個月：零）。

7.

母公司普通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權益持有人應佔期內虧損及期內發行在外普通股加權
平均數325,981,465股（截至2025年6月30日止六個月：288,040,355股）計算。
每股攤薄虧損金額乃根據母公司普通權益持有人應佔期內虧損計算，而計算時所用普通股
加權平均數乃期內發行在外普通股數目，與計算每股基本虧損時所使用者相同，並假設所
有攤薄潛在普通股視作行使或轉換為普通股而無償發行的普通股的加權平均數。

46

每股基本及攤薄虧損按以下基礎計算：

虧損
母公司普通權益持有人應佔虧損

股份
用於計算每股基本虧損的期內發行在外普通股加權平均數 *
*

截至2026年
6月30日
止六個月
（未經審計）
人民幣千元

截至2025年
6月30日
止六個月
（經審計）
人民幣千元

(153,685)

(183,096)

截至2026年
6月30日
止六個月
（未經審計）

截至2025年
6月30日
止六個月
（經審計）

325,981,465

288,040,355

加權平均股份數目已計及所持庫存股的影響。截至2025年6月30日止六個月，母公司
普通權益持有人應佔每股虧損已予以重列，以反映自2025年12月10日生效的本公司
股份拆細（「股份拆細」）的影響。

47

8.

9.

預付款項、其他應收款項及其他資產
2026年
6月30日
（未經審計）
人民幣千元

2025年
12月31日
（經審計）
人民幣千元

非流動：
物業、廠房及設備預付款項

26,624

97,062

流動：
預付款項
押金及其他應收款項
可抵扣增值稅
預付開支

5,332
2,124
46,577
511

3,513
1,333
21,904
837

總計

54,544

27,587

貿易應收款項
於報告期間末，貿易應收款項的賬齡分析（根據交易日期及扣除虧損撥備）如下：
2026年
6月30日
（未經審計）
人民幣千元

2025年
12月31日
（經審計）
人民幣千元

6,906

98

2026年
6月30日
（未經審計）
人民幣千元

2025年
12月31日
（經審計）
人民幣千元

304

8

1年內

10. 貿易應付款項
於報告期末，貿易應付款項的賬齡分析（根據發票日期）如下：

3個月內
貿易應付款項並不計息，一般按三個月的期限結算。

48

11. 其他應付款項及應計費用
附註

應付薪資
合約負債
購買物業、廠房及設備的應付款項
其他應付款項
應付關聯方款項
訴訟虧損撥備
物業、廠房及設備的應計款項
應付稅項
應計上市開支

(a)
(b)

總計

2026年
6月30日
（未經審計）
人民幣千元

2025年
12月31日
（經審計）
人民幣千元

12,436
6,549
48,029
40,467
70
55,080
10,239
2,064
703

18,331
1,818
26,430
50,797
127
55,080
42,028
3,471
12,410

175,637

210,492

附註：
(a)

於2026 年6 月30 日，本集團涉及與一家生物技術公司簽訂的技術轉讓協議相關的訴
訟。
根據中國地方法院於 2025 年 5 月作出的一審判決，本集團被責令 (i) 支付約人民幣
55,080,000 元，該金額已於截至2025 年6 月30 日止六個月的綜合損益表中的「其他
開支」項下「訴訟虧損撥備」中確認；及 ( i i ) 退還上述原告墊款餘額，其中人民幣
18,360,000元已於2025年12月31日於「其他應付款項」中確認。
於2026 年7 月，中國高等法院頒令撤銷上述裁決，並將案件發回一審法院重審。於
2026年6月30日，本集團已就該訴訟風險計提全額撥備。

(b)

於2025年12月31日，本集團涉及與一家製藥企業的建設項目相關的訴訟。
根據中國地方法院於2025年8月及2026年3月作出的一審及二審判決，本集團須對未
付建築費用和適用利息承擔連帶責任，該金額已於2025年12月31日在「其他應付款
項」的「物業、廠房及設備的應計款項」中確認，約為人民幣31,789,000元。
於2026年6月，中國地方法院已向該訴訟的另一名被告強制執行建築費用和利息，因
此，本集團不再承擔與該訴訟相關的支付責任，且相應負債已悉數撥回。

49

於聯交所及本公司網站刊發中期業績公告及中期報告
本中期業績公告已於本公司網站( www.baopharma.com )及香港聯交所網站
( www.hkexnews.hk )刊發。載有上市規則要求所有相關資料的本公司2026年中期
報告，將於適當時候寄發予股東（如要求）並刊載於上述網站。

釋義
於本公告中，除文義另有所指外，下列詞彙具有以下涵義。該等詞彙及其定義未
必與任何行業標準定義一致，且未必可直接與本公司在同一行業經營的其他公司
所採用的類似詞彙進行比較。
「君聯生物技術」

指

成都盛世君聯生物技術有限公司，一家於 2016 年3 月
10 日在中國成立的有限責任公司，由本公司擁有約
16.92%股份

「組織章程細則」或
「細則」

指

本公司於2025 年1 月21 日以特別決議案方式採納並自
上市日期起生效的組織章程細則，經不時修訂、補充
或以其他方式修改

「審核委員會」

指

董事會審核委員會

「董事會」

指

本公司董事會

「CDE」

指

國家藥監局藥品審評中心

「企業管治守則」

指

上市規則附錄C1所載《企業管治守則》

「中國」

指

中華人民共和國，惟僅就本公告及作地區參考而言，
本公告對於「中國」的提述並不適用於香港、中國澳門
特別行政區及台灣

「公司條例」

指

香港法例第622 章《公司條例》，經不時修訂、補充或
以其他方式修改

「核心產品」

指

具有上市規則第十八A章賦予的涵義，並指為符合上
市規則第十八A章及《新上市申請人指南》第2.3章項下
資格規定而界定的產品；就本公告而言，我們的核心
產品指KJ017、KJ103及SJ02
50

「本公司」

指

上海寶濟藥業股份有限公司，一家於2023 年7 月26 日
在中國註冊成立的股份有限公司，或如文義所指（視乎
情況而定），其前身公司上海寶濟藥業有限公司，一家
於2019年12月16日根據中國法律成立的有限責任公司

「相應期間」

指

截至2025年6月30日止六個月

「CSO」

指

合約銷售組織，一家以合約形式向另一家公司提供外
包銷售及營銷服務的公司

「董事」

指

本公司董事

「DIVA」

指

困難靜脈通路，難以找到或進入靜脈進行抽血或靜脈
插管等醫療程序的情況

「DMF」

指

藥物主文件，向FDA遞交的文件，用於提供生產、加
工、包裝及儲存人類藥物產品所用的設施、工藝或物
品的機密詳細信息

「FDA」

指

美國食品藥品監督管理局

「GCP」

指

藥物臨床試驗質量管理規範

「全球發售」

指

香港公開發售及國際發售（各自定義見招股章程）

「GMP」

指

藥品生產質量管理規範

「本集團」或
「我們」

指

本公司及其不時附屬公司

「H股」

指

本公司股本中每股面值人民幣0.20 元的普通股，以港
元認購及買賣，並於聯交所上市

「港元」

指

港元，香港法定貨幣

「香港」

指

中國香港特別行政區

「香港聯交所」或
「聯交所」

指

香港聯合交易所有限公司

「IND」

指

試驗性新藥

「上市」

指

H股於聯交所主板上市
51

「上市日期」

指

「上市規則」

指 《聯交所證券上市規則》，經不時修訂

「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》

「國家藥監局」

指

中國國家藥品監督管理局（前身為國家食品藥品監督管
理總局）

「招股章程」

指

本公司就上市而刊發的日期為2025 年12 月2 日的招股
章程

「研發」

指

研究及開發

「報告期間」

指

截至2026年6月30日止六個月

「人民幣」

指

中國的法定貨幣

「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

「股份」

指

本公司股本中每股面值人民幣0.20 元的普通股，包括
非上市股份及H股

「股東」

指

本公司股東

「庫存股」

指

具有上市規則界定的涵義

「美國」

指

美利堅合眾國、其領土及屬地、美國的任何州以及哥
倫比亞特區

「美元」

指

美元，美國法定貨幣

「%」

指

百分比

2025年12月10日

承董事會命
上海寶濟藥業股份有限公司
董事長兼執行董事
劉彥君博士
中國上海，2026年8月28日

截至本公告日期，董事會包括(i)執行董事劉彥君博士、王徵女士及李翠女士；(ii)
職工代表董事孫玉華先生；(iii)非執行董事林佳陵女士、刁雋桓先生及Li Chen先
生；及(iv)獨立非執行董事蔡仲曦先生、曾凡一博士、鞠佃文博士及張森泉先生。
52