基石药业发布2026年中期业绩，收入同比大增但仍亏损，CS2009推进至拟年内启动III期

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CStone Pharmaceuticals
基石藥業
(Incorporated in the Cayman Islands with limited liability)

(Stock Code: 2616)

ANNOUNCEMENT OF INTERIM RESULTS
FOR THE SIX MONTHS ENDED JUNE 30, 2026
The board (the “ Board ”) of directors (the “ Directors ”) of CStone Pharmaceuticals (the
“Company” or “CStone”) is pleased to announce the unaudited consolidated results of the
Company and its subsidiaries (together, the “Group”, “we” or “us”) for the six months ended June
30, 2026 (the “Reporting Period”), together with comparative figures for the six months ended
June 30, 2025.
FINANCIAL HIGHLIGHTS
International Financial Reporting Standards (“IFRS”) Measures:
•

Revenue was RMB205.1 million for the six months ended June 30, 2026, representing
an increase of RMB155.7 million or 315.2% compared to RMB49.4 million for the six
months ended June 30, 2025. The revenue is composed of RMB183.2 million from sales
of pharmaceutical products (avapritinib, pralsetinib and sugemalimab), RMB6.9 million
from license fee income, and RMB15.0 million from royalty income of sugemalimab.
The substantial revenue growth was primarily driven by a significant increase in sales of
pharmaceutical products, particularly pralsetinib, following its successful inclusion in the
National Reimbursement Drug List (“NRDL”) effective from January 2026, which led to a
marked sales ramp-up.

•

Cost of revenue was RMB110.9 million for the six months ended June 30, 2026, representing
a decrease of RMB31.3 million from RMB142.2 million for the six months ended June 30,
2025, primarily due to the write-off of inventory write-downs that had been recognized in
2025 and charged to cost of revenue, as the corresponding inventories were sold during the
current period.

•

Research and development expenses were RMB205.5 million for the six months ended June
30, 2026, representing an increase of RMB100.3 million from RMB105.2 million for the six
months ended June 30, 2025, primarily due to an increase in third-party contracting costs
for clinical trials, including the Phase II study for CS2009, and for other research programs,
including CS5006 and CS5007.

1

•

Administrative expenses were RMB51.3 million for the six months ended June 30, 2026,
representing an increase of RMB7.8 million from RMB43.5 million for the six months ended
June 30, 2025, primarily due to an increase in employee costs.

•

Selling and marketing expenses were RMB73.1 million for the six months ended June 30,
2026, representing an increase of RMB37.4 million from RMB35.7 million for the six months
ended June 30, 2025, primarily due to an increase in channel service fee.

•

Loss for the period was RMB252.3 million for the six months ended June 30, 2026,
representing a decrease in loss of RMB17.9 million, from RMB270.2 million for the six
months ended June 30, 2025, primarily due to a shift from gross loss to gross profit, partially
offset by increases in research and development expenses and selling and marketing expenses.

•

Cash and cash equivalents and time deposits were RMB1,560.2 million as of June 30,
2026.

Non-International Financial Reporting Standards (“Non-IFRS”) Measures:
•

Research and development expenses, excluding the share-based payment expenses, were
RMB193.4 million for the six months ended June 30, 2026, representing an increase of
RMB91.3 million from RMB102.1 million for the six months ended June 30, 2025, primarily
due to an increase in third-party contracting costs for clinical trials, including the Phase II
study for CS2009, and for other research programs, including CS5006 and CS5007.

•

Administrative and selling and marketing expenses, excluding the share-based payment
expenses, were RMB115.2 million for the six months ended June 30, 2026, representing an
increase of RMB38.0 million from RMB77.2 million for the six months ended June 30, 2025,
primarily due to an increase in channel service fee and employee costs.

•

Loss for the period excluding the share-based payment expenses was RMB230.9 million
for the six months ended June 30, 2026, representing a decrease in loss of RMB34.2 million,
from RMB265.1 million for the six months ended June 30, 2025, primarily due to a shift from
gross loss to gross profit, partially offset by increases in research and development expenses
and selling and marketing expenses.

2

BUSINESS HIGHLIGHTS
For the six months ended June 30, 2026 and up to the date of this results announcement, CStone
made significant progress across both its proprietary Pipeline 2.0 portfolio and its commercial
franchise, advancing the Company’s strategy to build a fully integrated, globally competitive
biopharmaceutical company. Headline achievements are set out below:
Clinical Stage Core Asset

•

CS2009, PD-1/VEGF/CTLA-4 trispecific antibody
–

Accelerating global clinical development toward Phase III registrational trials by
year-end 2026
The ongoing global Phase I (dose-escalation)/II (expansion) trial has enrolled more
than 300 patients across China and Australia, with U.S. Investigational New Drug
(“ IND ”) clearance obtained in February 2026. The study features a multi-cohort,
parallel expansion design to evaluate the safety, tolerability, pharmacokinetics (“PK”),
pharmacodynamics (“PD”), and preliminary efficacy of CS2009 as both monotherapy
and in combination regimens.
CStone plans to initiate the first wave of global Phase III multi-regional clinical trials
(“MRCTs”) for CS2009 by the end of 2026. Planned registrational studies include
first-line non-small cell lung cancer (“NSCLC”) in combination with chemotherapy
(versus pembrolizumab plus chemotherapy), and first-line metastatic colorectal cancer
(“mCRC”) in combination with chemotherapy (versus bevacizumab plus chemotherapy),
with additional registrational studies planned for 2027 and the following years.

–

CS2009 continues to validate its potential as a next-generation I/O backbone
At the 2026 American Society of Clinical Oncology (“ASCO”) Annual Meeting (the
“2026 ASCO Annual Meeting”), CStone presented comprehensive Phase I/II data from
the ongoing global multicenter trial. As of the data cutoff date of August 2026, updated
monotherapy efficacy data from the ongoing global Phase I/II trial of CS2009, reflecting
a longer follow-up than the ASCO 2026 presentation at the 2026 ASCO Annual Meeting
continued to demonstrate robust and deepening antitumor activity across multiple tumor
types. Three important key clinical validations are achieved from over 300 patient data:
•

Proof of safety
Across all dose levels, no dose-limiting toxicities (“DLTs”) were observed, and
the maximum tolerated dose (“MTD”) was not reached. At the 2026 ASCO Annual
Meeting, the incidence of Grade ≥3 treatment-related adverse events (“TRAEs”)
and immune-related adverse events (“irAEs”) was 24.6% and 12.7%, respectively.
Notably, the incidence of Grade ≥3 VEGF-related TRAEs was only 5.1%. No
excessive toxicities typically associated with CTLA-4/PD-(L)1 combinations were
observed. As of August 2026, the safety profile of CS2009 remained consistent
with that presented at the 2026 ASCO Annual Meeting, with no new safety signals
identified.

3

•

Proof of CTLA-4 activities and efficacy
Dose-dependent upregulation of ICOS on CD4+ T cells was observed as a
pharmacodynamic biomarker of CTLA-4 blockade. Activity was also seen in “cold
tumor” not sensitive to PD-(L)1 mAb:

•

–

Later-line monotherapy for mCRC (30 mg/kg): the objective response rate
(“ORR”) was 20.0% (3/15) and the disease control rate (“DCR”) was 93.3%
(14/15).

–

Later-line monotherapy for soft-tissue sarcoma (“STS”): the ORR was 38.5%
(5/13) and the DCR was 69.2% (9/13).

–

Later-line monotherapy for non-clear cell renal cell carcinoma (“nccRCC”):
the ORR was 42.9% (3/7) and the DCR was 100.0% (7/7).

–

Promising anti-tumor activity in later-line post immuno-oncology (“IO”)
NSCLC monotherapy: ORR was 23.8% (5/21), DCR was 61.9% (13/21).
Among patients who had previously received immunotherapy plus
platinum-based chemotherapy (n=13), ORR was 38.5% (5/13) and DCR was
84.6% (11/13).

Proof of broad efficacy
Monotherapy and chemo-combination activity in first-line and later-line NSCLC:
–

First-line NSCLC monotherapy (PD-L1 tumor proportion score (“TPS”)≥1%;
enrollment completed): ORR of 61.7% (29/47) and DCR of 93.6% (44/47),
including ORR of 70.8% (17/24), DCR 91.7% (22/24) in patients treated at
30 mg/kg; in the PD-L1 TPS ≥50% group (n=24), ORR was 83.3% (20/24)
and DCR was 95.8% (23/24) (versus ORR of 81.3% (13/16) at the 2026
ASCO cutoff), including ORR of 100.0% (11/11) and DCR of 100.0%
(11/11) in patients treated at 30 mg/kg. After medium follow up of 6 months,
median progression-free survival (“PFS”) and DOR have not been reached.

–

Second-line or later NSCLC monotherapy (30 mg/kg): ORR of 28.0% (7/25)
and DCR of 60.0% (15/25), with a 6-month DOR rate of 83.3% (versus
ORR of 24.0% and a 6-month DOR rate of 80.0% at the 2026 ASCO Annual
Meeting cutoff). Across all evaluated dose levels (n=54), ORR was 16.7%
(9/54) and DCR was 68.5% (37/54), with a 6-month DOR rate of 87.5%
(versus 85.7% at the 2026 ASCO Annual Meeting cutoff).

–

Later-line NSCLC (second/third-line combination therapy, n=6): ORR of
66.7% (4/6), DCR of 100.0% (6/6). Data are as of the 2026 ASCO data
cutoff and will be updated at the 2026 European Society for Medical
Oncology (“ESMO”) Congress (the “2026 ESMO Congress”).

–

First-line squamous NSCLC combination therapy (PD-L1-low/negative, TPS
≤5%, n=8): ORR of 75.0% (6/8), DCR of 100.0% (8/8); notably, the ORR
reached 100.0% (4/4) in the PD-L1-negative subgroup. Data are as of the
2026 ASCO data cutoff and will be updated at the 2026 ESMO Congress.
4

Robust Chemo-combo efficacy in the first-line mCRC, mostly proficient mismatch
repair or microsatellite stable (“pMMR/MSS”):
–

First-line mCRC (with XELOX, n=6): ORR of 66.7% (4/6), DCR of
100.0% (6/6). Data as of 2026 ASCO cutoff, will be updated at 2026 ESMO
Congress.

Promising monotherapy activity observed in metastatic castration-resistant prostate
cancer (“mCRPC”), ovarian cancer, triple-negative breast cancer, gastric cancer,
endometrial cancer, as well as STS and nccRCC.

–

Upcoming two oral presentations of CS2009 at the 2026 ESMO Congress
The clinical research results of CS2009 have been accepted for two Rapid Oral
presentations at the 2026 ESMO Congress. The presentations will feature Phase I/II
clinical data of CS2009 in patients with advanced NSCLC and mCRC.

Other Clinical Stage Asset

•

CS5007, EGFR/HER3 ADC
–

Advancing CStone ’s proprietary ADC platform into the clinic
The Company initiated the Phase I first-in-human study in June 2026. This trial consists
of dose-escalation and dose-expansion cohorts evaluating CS5007 as a monotherapy in
patients with advanced solid tumors, and will be conducted concurrently in Australia
and China. CStone presented preclinical data for CS5007 at the 2026 American
Association for Cancer Research (“AACR”) Annual Meeting, further supporting its
broad-spectrum anti-tumor potential.
The advancement of CS5007 into the clinic also marks a key milestone for CStone’s
proprietary Antibody-Drug Conjugate (“ ADC ”) platform, broadening the nextgeneration Pipeline 2.0 modality.

Commercial Products

•

CEJEMLY ® (sugemalimab), anti-PD-L1 antibody
–

Global regulatory expansion and inclusion in ESMO guidelines
Following the initial marketing authorizations of sugemalimab in the European Union
(“EU”) and the United Kingdom (“U.K.”) for Stage IV NSCLC, sugemalimab received
additional approvals in the EU in November 2025 and subsequently in the U.K. in
February 2026 as monotherapy for adults with unresectable Stage III NSCLC whose
disease has not progressed following platinum-based chemoradiotherapy (“CRT”).
Meanwhile, marketing authorization applications for sugemalimab have either been
approved or are under active review in nearly 30 countries worldwide.
In March 2026, CEJEMLY ® (sugemalimab) was included in the ESMO Early and
Locally Advanced NSCLC Living Guideline. Sugemalimab received a Level [I, A]
recommendation for consolidation therapy in patients with unresectable Stage III
NSCLC who have not progressed after concurrent or sequential chemoradiotherapy.
5

–

Fifth international commercialization partnership through strategic alliances
In June 2026, CStone entered into an exclusive commercialization agreement with
Arrotex Pharmaceuticals Pty Ltd (“Arrotex”), Australia’s largest privately owned
pharmaceutical company with established oncology commercialization capabilities
and distribution infrastructure across Australia and New Zealand. This milestone
expands sugemalimab’s global commercialization network to five strategic partnerships,
covering more than 60 countries and regions across Europe, the Middle East, Africa,
Latin America, and Oceania.

•

Pralsetinib capsules, RET inhibitor
–

NRDL inclusion and accelerated commercial growth
Following the inclusion of pralsetinib capsules (100 mg) in China’s NRDL in late 2025,
effective January 1, 2026, patient access has improved significantly. In the seven-month
period ending July 2026, pralsetinib ’s in-market sales volume increased by almost 500%
year-over-year.

–

Localized manufacturing approval supporting commercial scalability
Following the approval by China ’s National Medical Products Administration
(“NMPA”) of the manufacturing localization application for pralsetinib capsules (100
mg), the first batch of locally-manufactured pralsetinib was released in China in 2026.

Preclinical/IND-enabling Stage Programs:

•

A balanced, differentiated early-stage portfolio spanning oncology and immunology/
inflammation
CStone ’s preclinical Pipeline 2.0 comprises innovative candidates across multispecific
antibodies, ADCs and other next-generation modalities, with potential first-in-class (“FIC”)
or best-in-class (“BIC”) opportunities spanning oncology, immunology, inflammation and
other high-value therapeutic areas.
The Company ’s proprietary ADC platform incorporates optimized linker technologies
designed to enable tumor-selective payload release and supports multiple Pipeline 2.0 ADC
candidates, including CS5007 (dual targeting epidermal growth factor receptor (“EGFR”) and
human epidermal growth factor receptor 3 (“HER3”) bispecific ADC), CS5006 (integrin β4
(“ITGB4”) ADC), and CS5008 (delta-like ligand 3 (“DLL3”) and SSTR2 bispecific ADC),
etc. The Company has also developed a proprietary next-generation ADC platform, including
dual-payload ADCs (e.g., CS5009, a B7H3/PD-L1 bispecific dual-payload ADC, and CS5010,
a biparatopic HER2-targeting dual-payload ADC) and novel-payload ADCs (e.g., CS5012, a
biparatopic HER2-targeting novel-payload ADC). In April 2026, CStone presented preclinical
data for CS5007, CS5006 and CS5008 at the 2026 AACR Annual Meeting, highlighting the
breadth and differentiation of its next-generation ADC pipeline.
Beyond oncology, CStone has expanded Pipeline 2.0 into immunology and inflammation
by leveraging its proprietary multispecific antibody platform. The Company has developed
CS2015 (OX40L/TSLP bispecific antibody) targeting Type 2 inflammatory diseases, CS2013
(BAFF/APRIL bispecific antibody) targeting B cell-mediated autoimmune diseases, CS2016
(TL1A/α4β7 bispecific antibody), and CS1016 (PD-1 agonist antibody).
6

FUTURE AND OUTLOOK
Our mission is to deliver transformative therapies through scientific excellence and technological
innovation, making high-quality treatments accessible worldwide to benefit patients and their
families.
We reaffirm our commitment to advancing a robust and differentiated pipeline by prioritizing
internal discovery capabilities and sustained R&D investments, while executing strategic
partnerships to unlock the global value of our in-market products. Key catalysts for the second half
of 2026 include:
•

•

Clinical milestones
–

Accelerate global development of CS2009 by advancing interactions with global
regulatory authorities, including the U.S. Food and Drug Administration (“FDA”),
on Phase III registrational trial design, with the first wave of global Phase III
MRCTs planned to be initiated by the end of 2026, while continuing to pursue global
partnerships.

–

Advance clinical development of CS5007 (EGFR/HER3 bispecific ADC), CS5006
(ITGB4 ADC), CS5008 (SSTR2/DLL3 ADC) and other early-stage candidates.

Innovation and technology
–

Further strengthen proprietary technology platforms, including multi-specific antibody
and next-generation ADC technologies, to support sustained expansion of the preclinical
pipeline.

–

Present key clinical data, including updated CS2009 data, at major international
scientific conferences, including two Rapid Oral presentations of CS2009 Phase I/II
data at the 2026 ESMO Congress.

CAUTIONARY STATEMENT REQUIRED BY RULE 18A.08(3) OF THE LISTING RULES:
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP OR MARKET ANY OF OUR
PIPELINE PRODUCTS SUCCESSFULLY.

7

MANAGEMENT DISCUSSION AND ANALYSIS
OUR VISION
To be a pioneer in enhancing global patient health through innovation.
OVERVIEW
CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical
company focused on the research and development of therapies for oncology, immunology,
inflammation, and other key disease areas. Dedicated to addressing patients’ unmet medical needs
in China and globally, the Company has made significant strides since its inception. To date,
the Company has successfully launched 4 innovative drugs and secured approvals for 21 new
drug applications covering 9 indications. The Company’s pipeline is balanced by 16 promising
candidates, featuring potentially FIC or BIC ADCs, multispecific antibodies, immunotherapies
and precision medicines. CStone also prides itself on a management team with comprehensive
experience and capabilities spanning the entire drug development spectrum, from preclinical
and translational research to clinical development, drug manufacturing, business development,
and commercialization. For details of any of the foregoing, please refer to the rest of this results
announcement and, where applicable, the Prospectus and prior announcements published on the
websites of The Stock Exchange of Hong Kong Limited (the “Stock Exchange”) and the Company.
Strategic Framework and Business Model
Our strategy is centered on delivering sustainable growth through the global advancement of
Pipeline 2.0 and maximizing the lifecycle value of our in-market products. We execute this strategy
via a capital-efficient, asset-light model that prioritizes internal resources on core competencies:
early discovery, translational science, and clinical development. By leveraging established
partnerships with premier contract research organizations (“CROs”) and contract development and
manufacturing organizations (“CDMOs”), we maintain operational agility without compromising
scientific rigor. Commercialization is executed through strategic collaborations in key geographic
markets, allowing us to amplify patient reach and revenue growth while preserving a sharp focus
on innovation. Going forward, we will continue to strengthen our research and clinical capabilities,
progress high-potential assets into later-stage development and adopt tailored global partnership
strategies to maximize the value of both our commercial portfolio and pipeline.

8

Product Pipeline
The following pipeline chart demonstrates the milestone and development status of our selected
assets as of the date of this results announcement:
–

Commercial/Late-stage Programs
Asset

Indication

POC

Pivotal

NDA

Marketed

Approval
CN

TW

HK

US

EU

UK

Partners

Partnering Regions

1L NSCLC
2L NSCLC
Pralsetinib (RET)

NSCLC

 Mainland China

TC
Multiple tumors
PDGFRA exon 18 GIST
PDGFRA D842V GIST
Avapritinib (KIT/PDGFRA)

 Mainland China

ISM1
Advanced SM1
1L Stage IV NSCLC

 Mainland China
 Switzerland and CEE

Stage III NSCLC

 Middle East and Africa

1L G/GEJ

Sugemalimab (PD-L1)

 Latin America

1L ESCC

CS1002 (CTLA- 4)

 West Europe and the UK

R/R ENKTL

 Australia & New Zealand

Solid tumors

 Greater China

CN = Mainland China, TW = Taiwan, China, HK = Hong Kong SAR, China, US = United States, EU = European Union, UK = United Kingdom, POC = Proof of Concept, NDA = New Drug Application, NSCLC = Non-small Cell Lung Cancer, TC
= Thyroid Cancer, GIST = Gastrointestinal Stromal Tumor, ISM = Indolent Systemic Mastocytosis, Advanced SM = Advanced Systemic Mastocytosis, G/GEJ = gastric/gastroesophageal junction adenocarcinoma, ESCC = Esophageal Squamous Cell
Carcinoma, R/R = Relapsed or Refractory, ENKTL = Extranodal NK/T Cell Lymphoma, CEE = Central & Eastern Europe
1.

–

POC study was conducted in North American and Europe. No clinical trials have been conducted in China while IND application is under preparation

Pipeline 2.0
Right

Indication

Discovery

Preclinical
Development

IND-Enabling

FIH

POC

Antibodies (Oncology)
CS2009 (PD- 1/VEGF/CTLA- 4 trispecific antibody)

Solid tumors

CS1012 (GDF- 15 antibody)

Solid tumors

ADCs (Oncology)
CS5001 1 (ROR1 ADC)

Solid tumors;
hematologic malignancies

CS5007 (EGFR/HER3 bispecific ADC)

Solid tumors

CS5006 (ITGB4 ADC)

Solid tumors

CS5008 (SSTR2/DLL3 bispecific ADC)

Solid tumors

CS5009 (B7H3/PD-L1 bispecific dual-payload ADC)

Solid tumors

CS5010 (HER2 biparatopic dual-payload ADC)

Solid tumors

CS5012 (HER2 biparatopic novel-payload ADC)

Solid tumors

Antibodies (Immunology & Inflammation)
CS2013 (BAFF/APRIL bispecific antibody)

Immunology & Inflammation

CS2015 (OX40L/TSLP bispecific antibody)

Immunology & Inflammation

CS1016 (PD- 1 agonist antibody)

Immunology & Inflammation

CS2016 (TL1A/α4β7 bispecific antibody)

Immunology & Inflammation
Global Rights

Note: Assets status denotes progress in the region(s) noted in the column titled “Rights”; FIH = First in Human, POC = Proof of Concept,
1.

CStone obtains the exclusive global right from LigaChem Biosciences, Inc. (LCB) to lead development and commercialization of LCB71/CS5001 outside the Republic of Korea

9

BUSINESS REVIEW
Commercial Products
To support our global growth strategy, we actively pursue strategic partnerships with leading
pharmaceutical and biotechnology companies. As of the date of this results announcement, we have
established multiple commercial collaborations across key markets worldwide. These partnerships
are designed to enhance the effectiveness and scalability of our commercialization efforts by
leveraging our partners’ established capabilities, expertise, and market presence. This approach
enables accelerated expansion into strategic international markets while allowing us to focus our
internal resources on advancing our core research and development pipeline.
Details on our commercial portfolio are set out below:

•

CEJEMLY ® (sugemalimab, anti-PD-L1 antibody) approved in China, the EU, and
U.K., with commercial expansion underway across more than 60 countries and regions
worldwide
–

Sugemalimab, developed by CStone using OmniRat® transgenic animal platform, is a
fully human, full-length anti-PD-L1 immunoglobulin G4 (“IgG4”) monoclonal antibody,
which may reduce the risk of immunogenicity and toxicity for patients.

–

Multiple indications approved by global regulators, validating clinical value.
The China NMPA has approved sugemalimab for five indications:
•

Stage IV NSCLC: In combination with pemetrexed and carboplatin, as the firstline treatment for patients with EGFR gene mutation-negative and anaplastic
lymphoma kinase (“ALK”)-negative metastatic non-squamous NSCLC; and in
combination with paclitaxel and carboplatin, as the first-line treatment for patients
with metastatic squamous NSCLC;

•

Stage III NSCLC: As monotherapy for the treatment of unresectable Stage
III NSCLC patients whose disease has not progressed following concurrent or
sequential platinum-based chemoradiotherapy;

•

R/R ENKTL: As monotherapy for the treatment of adult patients with relapsed or
refractory (“R/R”) extranodal natural killer/T-cell lymphoma (“ENKTL”);

•

ESCC: In combination with platinum and fluoropyrimidine-based chemotherapy
for first-line treatment of unresectable locally advanced, recurrent or metastatic
esophageal squamous cell carcinoma (“ESCC”); and

•

G/GEJ adenocarcinoma: In combination with fluoropyrimidine and platinumcontaining chemotherapy for first-line treatment of unresectable locally advanced
or metastatic gastric or gastroesophageal junction (“G/GEJ”) adenocarcinoma with
PD-L1 expression (CPS≥5).

10

The European Commission (“EC”) and Medicines and Healthcare products Regulatory
Agency (“MHRA”) in the U.K. have approved sugemalimab for two indications:

–

•

Stage IV NSCLC: CEJEMLY® in combination with platinum-based chemotherapy
is indicated for the first-line treatment of adults with metastatic NSCLC with no
sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations;
and

•

Stage III NSCLC: CEJEMLY® as monotherapy is indicated for the treatment
of unresectable Stage III NSCLC with no sensitising EGFR mutations, or ALK,
ROS1 genomic tumor aberrations in adults whose tumors express PD-L1 on ≥1%
of tumor cells and whose disease has not progressed following platinum-based
chemoradiotherapy.

Expand into Oceania through the fifth strategic partnership
In June 2026, we entered into an exclusive commercialization agreement with Arrotex
to commercialize the asset in Australia and New Zealand. This milestone builds on
our prior partnerships with Ewopharma AG (“Ewopharma”), Pharmalink Store LLC
OPC (“Pharmalink”), Laboratorios Stein S.A. (“SteinCares”), and Istituto Gentili
S.R.L. (“Gentili”) in 2024 and 2025. Together, these collaborations have expanded
sugemalimab’s commercial footprint to over 60 countries and regions across Europe, the
Middle East and Africa, Latin America, and Oceania.

–

ESMO Guideline Level [I, A] recommendations and academic recognition
•

ESMO Guideline recommendations: In March 2026, sugemalimab received a
Level [I, A] recommendation in the ESMO Early and Locally Advanced NSCLC
Living Guideline for consolidation therapy in patients with EGFR wild-type and
no ALK or ROS1 genomic tumour aberrations, unresectable Stage III NSCLC
who have not progressed after concurrent or sequential chemoradiotherapy.
This recommendation is expected to significantly facilitate market access for
sugemalimab in the European Union and other regions, expanding patient reach,
thus strengthening its global commercialization.
Previously, in February 2025, sugemalimab in combination with chemotherapy
also received a Level [I, A] recommendation from the ESMO Non-OncogeneAddicted Metastatic NSCLC Living Guideline for the first-line treatment of both
squamous and non-squamous metastatic (Stage IV) NSCLC. To date, both NSCLC
indications for which sugemalimab is approved in the EU and U.K. are now
included in ESMO guidelines, underscoring its recognized clinical value.

•

Publications and presentations: Furthermore, clinical data from multiple studies
of sugemalimab have been featured dozens of times across leading international
peer-reviewed medical journals and major scientific congresses, including The
Lancet Oncology, Nature Cancer, JAMA (Journal of the American Medical
Association) , ESMO, and ASCO. This sustained academic recognition highlights
the strength of the clinical evidence supporting sugemalimab and its growing
recognition within the global oncology community.

11

•

*

Pralsetinib capsules (RET inhibitor) partnership with Allist: NRDL inclusion and
commercial growth
–

Pralsetinib capsules, a FIC rearranged during transfection (“RET”) inhibitor in China,
has been approved by China’s NMPA for the treatment of adults with locally advanced
or metastatic RET fusion-positive NSCLC. In addition, this medicine has been approved
by the Department of Health of the Government of Hong Kong (“HK DoH”) for the
treatment of patients with RET fusion-positive locally advanced or metastatic NSCLC,
and it has been approved by the Taiwan FDA (“TFDA”) for the treatment of adult
patients with locally advanced or metastatic RET fusion-positive NSCLC and advanced
or metastatic RET fusion-positive TC. This medicine (GAVRETO®) is also approved by
the FDA for the treatment of adult patients with metastatic RET fusion-positive NSCLC
as detected by an FDA approved test, and adult and pediatric patients 12 years of age
and older with advanced or metastatic RET fusion-positive thyroid cancer who require
systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is
appropriate)*.

–

In 2026, we continue to integrate pralsetinib capsules into Allist’s highly synergistic
lung cancer franchise, enabling the product to benefit from Allist’s mature commercial
team and broad market coverage, while simultaneously allowing us to reduce operating
costs associated with pralsetinib commercialization and improve overall profitability.

–

In December 2025, pralsetinib capsules (100 mg) was included in the latest NRDL
released by China’s National Healthcare Security Administration. The updated NRDL
took effect on January 1, 2026. In the seven-month period ended July 2026, pralsetinib’s
in-market sales volume increased by almost 500% year-over-year.

–

Following China’s NMPA approval of the manufacturing localization application for
pralsetinib capsules (100 mg) in July 2025, we successfully produced and released the
first domestically manufactured batch in May 2026. The supply chain is now gradually
transitioning from imported products to end-to-end domestic production – from
active pharmaceutical ingredient (“API”) to finished drug product. This strategic shift
significantly enhances cost efficiency and supply chain resilience.

–

Pralsetinib capsules has been included in 11 of China’s national guidelines for testing
and treatment in multiple therapeutic areas, such as NSCLC. In 2023, pralsetinib was
recommended by the 2023 Chinese Society of Clinical Oncology (“CSCO”) NSCLC
guideline, which recommended RET mutation gene testing and pralsetinib in the
treatment of RET-positive NSCLC patients. In 2024, pralsetinib as a treatment for Stage
IV RET fusion-positive NSCLC has been upgraded to a Level 1 recommendation in the
2024 CSCO NSCLC guideline.

This indication is approved under accelerated approval based on ORR and DOR. Continued approval for this
indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

12

•

Avapritinib tablets (KIT/PDGFRA inhibitor) partnership with Hengrui: domestic supply
secured and NRDL inclusion renewed
–

Avapritinib tablets, a FIC KIT/PDGFRA inhibitor, has been approved by China’s NMPA
for the treatment of adults with unresectable or metastatic gastrointestinal stromal
tumor (“GIST”) harboring the PDGFRA exon 18 mutation, including PDGFRA D842V
mutations. Avapritinib was approved by the HK DoH and TFDA for the treatment of
adults with unresectable or metastatic GIST harboring a PDGFRA D842V mutation.
Avapritinib is also approved by the U.S. FDA for the treatment of three indications:
adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation,
including PDGFRA D842V mutations, adults with advanced systemic mastocytosis
(advanced SM), including aggressive SM (“ ASM ”), and SM with an associated
hematological neoplasm (“SM-AHN”) and mast cell leukemia (“MCL”), and adults with
indolent systemic mastocytosis (“ISM”). This medicine (AYVAKYT®) is also approved
in Europe for the treatment of adults with unresectable or metastatic GIST harboring
the PDGFRA D842V mutation, adults with ASM, SM-AHN or MCL, after at least one
systemic therapy, and adults with ISM with moderate to severe symptoms inadequately
controlled on symptomatic treatment.

–

In July 2024, we entered into a commercial partnership with Jiangsu Hengrui
Pharmaceuticals Co., Ltd. (“Hengrui”) for the exclusive promotion rights of avapritinib
tablets in mainland China. China’s NMPA has approved the manufacturing localization
application of avapritinib (300 mg and 100 mg) in 2024, and domestic supply was
launched in February 2025, with a significant increase in gross margin.

–

We continued to improve the accessibility and affordability of avapritinib tablets.
Following its initial inclusion in December 2023, avapritinib was also successfully
renewed on the NRDL in December 2025 for the treatment of adult patients with
unresectable or metastatic GIST harboring the PDGFRA exon 18 mutation, including
PDGFRA D842V mutations. The latest NRDL took effect on January 1, 2026.

–

Avapritinib tablets is recommended by several authoritative guidelines, including
the 2025 CSCO GIST guideline, 2022 CSCO GIST guideline and the 2022 Chinese
Guideline for Diagnosis and Treatment of Systemic Mastocytosis in Adults.

13

Clinical Stage Core Product

CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody): Updated global Phase I/II clinical data
further validates its potential as a next-generation I/O backbone and supports its global
development strategy
•

CS2009, a core asset under the Company’s Pipeline 2.0, is a potential FIC/BIC PD-1/
VEGF/CTLA-4 trispecific antibody independently developed by CStone. By simultaneously
targeting three clinically validated pathways, namely PD-1, VEGFA, and CTLA-4, CS2009
is designed to achieve synergistic anti-tumor activity through multiple mechanisms of action.
Specifically, PD-1 blockade restores T cell effector function, CTLA-4 blockade promotes
T cell activation and proliferation, and VEGFA blockade inhibits tumor angiogenesis
and remodels the tumor microenvironment (“ TME ”). In the TME, the anti-PD-1 and
anti-CTLA-4 activities of CS2009 are significantly enhanced by crosslinking with VEGFA,
while its preferential, avidity-driven engagement of PD-1 and CTLA-4 on double-positive
tumor-infiltrating T cells (including effector T cells and regulatory T cells) strengthens
its binding affinity and checkpoint inhibitory activity. In the periphery, the monovalent,
low-affinity CTLA-4 arm of CS2009 does not effectively block CTLA-4/CD80 interactions
on CTLA-4 single-positive T cells, thereby sparing these cells from over-activation and
reducing the risk of systemic autoimmune toxicity. This differentiated mechanism is designed
to broaden the therapeutic window compared with conventional PD-1/CTLA-4 combination
therapies.

•

Patient enrollment is actively ongoing in the global, multicenter Phase II expansion study
of CS2009. This multi-cohort, parallel expansion study is designed to evaluate the efficacy,
safety, tolerability, and PK/PD of CS2009 as monotherapy and in combination regimens in
19 cohorts across 12 solid tumor indications, including NSCLC, CRC, extensive-stage small
cell lung cancer (“ES-SCLC”), cervical cancer (“CC”), GC/GEJC, ESCC, platinum-resistant
ovarian cancer (“PROC”), triple-negative breast cancer (“TNBC”), HCC, pancreatic cancer,
renal cell carcinoma (“RCC”), and MSI-H solid tumors.

•

Following the U.S. IND clearance obtained in February 2026, the Company is preparing the
clinical safety and efficacy datasets and chemistry, manufacturing and controls (“CMC”)
readiness for interactions with the U.S. FDA to align on the design of the planned first-wave
global Phase III MRCTs, aiming for initiation by the end of 2026, including CS2009 in
combination with chemotherapy versus pembrolizumab plus chemotherapy in first-line
NSCLC, CS2009 in combination with chemotherapy versus bevacizumab plus chemotherapy
in first-line mCRC, etc. The Company continues to engage in in-depth discussions with
global pharmaceutical companies regarding potential global partnerships.

•

At the 2026 ASCO Annual Meeting, CStone presented comprehensive Phase I/II data from
the ongoing global multicenter trial. CS2009 demonstrates broad-spectrum anti-tumor activity
across multiple tumor types, a favorable safety and tolerability profile, and encouraging PK/
PD characteristics.
Across all dose levels, no DLTs were observed, and the MTD was not reached. The incidence
of Grade ≥3 TRAEs and irAEs was 24.6% and 12.7%, respectively. Notably, Grade ≥3
VEGF-related TRAEs were observed in only 5.1% of patients. No excessive toxicities
typically associated with PD-(L)1 and CTLA-4 combination therapies were observed.

14

The broad-spectrum antitumor activity of CS2009 presented at ASCO 2026 is summarized
below. Updated monotherapy data (as of the August 2026 cutoff) are discussed in a later
section; the data presented here pertain to combination therapies.
–

First-line NSCLC
PD-L1-low/negative (TPS ≤5%) squamous NSCLC + chemotherapy (n=8): ORR
of 75.0% (6/8) and DCR of 100.0% (8/8); ORR reached 100.0% (4/4) in the
PD-L1-negative subgroup.

–

Later-line NSCLC
Second-/third-line combination therapy (n=6): ORR of 66.7% (4/6) and DCR of 100.0%
(6/6).

–

mCRC
First-line XELOX combination (n=6): ORR of 66.7% (4/6) and DCR of 100.0% (6/6).

•

As of the data cutoff date of August 2026, updated monotherapy efficacy data from the
ongoing global Phase I/II trial of CS2009, reflecting a longer follow-up than the ASCO
2026 presentation, continued to demonstrate robust and deepening antitumor activity across
multiple tumor types. Evaluable patients are defined as those with at least one post-baseline
tumor assessment:
–

In the first-line NSCLC monotherapy cohort (PD-L1 TPS ≥1%, 20 or 30 mg/kg once
every 3 weeks (“Q3W”); enrollment completed), 47 evaluable patients were assessed:
ORR was 61.7% (29/47) and DCR was 93.6% (44/47), including ORR of 70.8% (17/24),
DCR 91.7% (22/24) in patients treated at 30 mg/kg, with consistent activity observed
in both squamous (ORR of 60.7% (17/28); DCR of 96.4% (27/28)) and non-squamous
(ORR of 63.2% (12/19); DCR of 89.5% (17/19)) disease. In the PD-L1 TPS ≥50%
group (24 evaluable patients), ORR was 83.3% (20/24) and DCR was 95.8% (23/24),
including ORR of 100.0% (11/11) and DCR of 100.0% (11/11) in patients treated at 30
mg/kg and ORR of 69.2% (9/13) and DCR of 92.3% (12/13) in patients treated at 20
mg/kg. After medium follow up of 6 months, median PFS and DOR were not reached.

–

In the second-line or later NSCLC monotherapy cohort, among 25 evaluable patients
treated at 30 mg/kg, ORR was 28.0% (7/25) and DCR was 60.0% (15/25), with a
6-month DOR rate of 83.3%. Among patients who had received prior immunotherapy
plus platinum-based doublet chemotherapy (n=13), ORR was 38.5% (5/13) and DCR
was 84.6% (11/13). Across all evaluated dose levels (N=54), ORR was 16.7% (9/54),
DCR was 68.5% (37/54), and the 6-month DOR rate was 87.5%.

–

In the later-line mCRC monotherapy cohort (30 mg/kg), 15 evaluable patients were
assessed, predominantly with pMMR/MSS disease: ORR was 20.0% (3/15) and DCR
was 93.3% (14/15).

–

In the later-line STS monotherapy cohort, 13 evaluable patients were assessed: ORR
was 38.5% (5/13) and DCR was 69.2% (9/13).

–

In the later-line nccRCC monotherapy cohort, 7 evaluable patients were assessed: ORR
was 42.9% (3/7) and DCR was 100.0% (7/7).
15

The safety profile of CS2009 remained consistent with that presented at the 2026 ASCO
Annual Meeting, with no new safety signals identified.
•

The clinical research results of CS2009 have been accepted for two Rapid Oral presentations
at the 2026 ESMO Congress. The presentations will feature Phase I/II clinical data of CS2009
in patients with advanced NSCLC and mCRC.

Other Clinical Stage Products

CS5001 (LCB71, ROR1 ADC):
•

CS5001 is a clinical-stage ADC targeting ROR1. CS5001 incorporates a proprietary
tumor-cleavable linker and pyrrolobenzodiazepine (“ PBD ”) prodrug payload and has
demonstrated potent anti-tumor activity in first-line and second-line diffuse large B-cell
lymphoma (“DLBCL”). The sponsor is temporarily pausing the trial to evaluate existing
clinical data for long-term benefit-risk and optimize doses and dosing schedule.

•

As of August 2026, combination therapy with R-CHOP in first-line DLBCL has demonstrated
broad and deep responses. Across the 40-90 μg/kg dose levels (n=31), the ORR was 100%,
and the complete response (“CR”) rate was 100% at each dose level.

CS5007 (EGFR/HER3 ADC): Potential BIC molecule enabled by CStone ’s proprietary ADC
platform, with global Phase I clinical trial initiated
•

Developed based on CStone’s in-house proprietary ADC technology platform, CS5007 is a
bispecific ADC targeting both EGFR and HER3, designed to address tumor heterogeneity
and potentially overcome resistance mechanisms associated with single-target therapies.
Preclinical data presented at AACR 2026 demonstrated exceptional plasma stability, potent
antigen-dependent cytotoxicity at nanomolar concentrations, broad antitumor activity across
multiple tumor types, including NSCLC, CRC, breast cancer (“BC”), SCCHN, and SCC.
Encouraging activity was also observed in cell line-derived xenograft (“CDX”) models with
challenging indications, including osimertinib-resistant tumors and EGFR low-expressing
tumors. CS5007 demonstrated a superior PK/PD profile with prolonged half-life. GLP
toxicology studies established the highest non-severely toxic dose (“HNSTD”) at 30 mg/kg,
supporting a broad therapeutic window.

•

The global multicenter Phase I clinical trial of CS5007 was initiated in Australia in June
2026, and the IND application was approved by China’s NMPA in August 2026 under the
innovative drug clinical trial approval pathway. The trial is a first-in-human study comprising
dose-escalation and dose-expansion cohorts evaluating CS5007 monotherapy in patients with
advanced solid tumors whose disease has progressed following standard therapies, who are
ineligible for standard treatment, or for whom no effective treatment options are available.
The study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary
antitumor activity of CS5007, while establishing the RP2D. The trial is being conducted
concurrently in Australia and China to accelerate global clinical development.

16

CS1002 (SHR-8068, anti-CTLA4 antibody): strategic Greater China partnership with
Hengrui and ongoing Phase III trial progress
•

In November 2021, we entered into an exclusive licensing agreement with Hengrui, pursuant
to which Hengrui obtained exclusive rights to research, develop, register, manufacture, and
commercialize CS1002/SHR-8068 in Greater China. CStone retained all rights to develop and
commercialize CS1002 outside Greater China.

•

Hengrui has initiated six pivotal clinical trials evaluating CS1002/SHR-8068 in combination
with other therapies across multiple solid tumor indications, including first-line treatment of
advanced or metastatic non-squamous NSCLC, first-line treatment of advanced or metastatic
NSCLC, perioperative therapy for locally advanced resectable rectal cancer, incurable HCC,
first-line treatment of advanced HCC, and first-line treatment of advanced biliary tract cancer
(“BTC”). In addition, Hengrui is advancing multiple Phase II studies evaluating CS1002/
SHR-8068 combination regimens in additional solid tumors, including perioperative treatment
of resectable NSCLC and HCC, CRC, RCC, G/GEJ adenocarcinoma, etc.

Preclinical/IND enabling stage candidates
The Company remains committed to pioneering next-generation therapeutics, including
multispecific antibodies, ADCs, and other innovative modalities. In addition, the Company has
expanded its early-stage research portfolio to include immunology, inflammation and other key
therapeutic areas. Leveraging its global development capabilities, CStone remains committed to
advancing these differentiated assets through international, multicenter clinical development to
accelerate global innovation and expand patient access.
Key pipeline advancements include:
•

In-house proprietary ADC technology platform: CStone is actively advancing nextgeneration ADC technologies, including innovative linker technologies designed to improve
systemic stability, tumor selectivity and therapeutic windows. The Company’s proprietary
tandem-cleavable β-glucuronide linker technology has demonstrated the following potential
advantages:
–

Enhanced hydrophilicity improving circulating stability of the entire molecule.

–

Tumor selective payload release through tandem cleavage mechanism.

–

Clinical validated semi-stochastic conjugation with maleimide function group for
manufacturability.

The proprietary ADC platform is designed to optimize ADC safety and efficacy profiles, expand
target compatibility, and support the development of multiple ADC candidates under CStone’s
Pipeline 2.0, including CS5006 (ITGB4 ADC), CS5007 (EGFR/HER3 bispecific ADC), and
CS5008 (DLL3/SSTR2 bispecific ADC). The Company has also developed a proprietary nextgeneration ADC platform, including dual-payload ADCs (e.g., CS5009, a B7H3/PD-L1 bispecific
dual-payload ADC, and CS5010, a biparatopic HER2-targeting dual-payload ADC) and novelpayload ADCs (e.g., CS5012, a biparatopic HER2-targeting novel-payload ADC). Notably,
preclinical data for CS5006, CS5007 and CS5008 were presented at the 2026 AACR Annual
Meeting, and the global Phase I clinical trial of CS5007 (EGFR/HER3 bispecific ADC) was
initiated in June 2026.
17

•

•

Other ADC pipeline candidates
–

CS5006 (ITGB4 ADC): CS5006 is a potential FIC ADC against novel pan-tumor target
integrin β4 (ITGB4), a transmembrane protein that exclusively pairs with integrin α6
(ITGA6) to form α6β4 heterodimer. Robust in vitro and in vivo evidence supports its
clinical development. This molecule targets diverse indications, including NSCLC,
SCCHN, CRC, etc.

–

CS5008 (SSTR2/DLL3 ADC): CS5008 is a novel SSTR2/DLL3 bispecific ADC using
CStone’s proprietary antibody and linker payload. Through dual targeting of SSTR2
and DLL3, which are frequently co-expressed in NENs, SCLC and other malignancies,
CS5008 aims to overcome tumor heterogeneity, a challenge inherent to mono-targeting
therapies.

Expansion into immunology and inflammation
Beyond oncology, CStone has expanded Pipeline 2.0 into immunology and inflammation
by leveraging its proprietary multispecific antibody platform. The Company has developed
multiple potential FIC/BIC bispecific antibody candidates with broad therapeutic potential for
immune-mediated diseases across rheumatology, nephrology, respiratory, gastroenterology,
dermatology, etc.
–

CS2013, a BAFF/APRIL bispecific antibody, targets B cell-mediated autoimmune
diseases, including but not limited to systemic lupus erythematosus (“SLE”), rheumatoid
arthritis (“RA”) and IgA nephropathy (“IgAN”).

–

CS1016, a PD-1 agonist antibody recognizing a membrane-proximal epitope of PD-1, is
discovered to deplete pathologic T cells with high level expression of PD-1, aiming to
tackle Y cell driven immunology diseases including RA and psoriatic arthritis (“PsA”),
etc.

–

CS2015, a bispecific antibody targeting OX40L and TSLP, is designed to treat Type
2 inflammatory diseases, including but not limited to atopic dermatitis, asthma and
chronic obstructive pulmonary disease, through dual inhibition of key regulators
involved in Th2-mediated inflammatory responses.

–

CS2016 (TL1A/α4β7 bispecific antibody), a bispecific antibody targeting TL1A and
α4β7, is designed to interrupt two crucial proteins involved in inflammatory bowel
diseases (“IBDs”).

Candidates are expected to advance toward IND submissions, representing important milestones in
CStone’s strategic expansion beyond oncology into high-value therapeutic areas with significant
unmet medical needs.
CAUTIONARY STATEMENT REQUIRED BY RULE 18A.08(3) OF THE LISTING RULES:
WE MAY NOT BE ABLE TO ULTIMATELY DEVELOP OR MARKET ANY OF OUR
PIPELINE PRODUCTS SUCCESSFULLY.

18

Business Development and Strategic Partnerships
Our business development team plays a pivotal role in advancing the Company’s strategic
growth objectives. Its efforts focus on expanding the commercialization of marketed products,
strengthening our clinical-stage pipeline with potential FIC and BIC assets, and acquiring
innovative technologies. As of the date of this results announcement, we have established strategic
partnerships with leading industry players, including Pfizer, Sanofi*, Hengrui, 3SBio Inc., Allist,
Ewopharma, Pharmalink, SteinCares, Gentili and Arrotex.
For our marketed products in mainland China, we entered into an exclusive commercialization
agreement with Allist for pralsetinib capsules in November 2023 and a strategic partnership with
Hengrui for avapritinib tablets in July 2024. Under both arrangements, the Company retains all
other rights in the territory, including development, registration, manufacturing, and distribution
rights.
For the global commercialization of CEJEMLY ® (sugemalimab), we continue to expand our
strategic partnership network across key international markets. These collaborations include
Ewopharma for Switzerland and 18 Central and Eastern European (“CEE”) markets, Pharmalink
for the Middle East and North Africa (“MENA”) region and South Africa, SteinCares for Latin
America (“LATAM”), Gentili for Western Europe and the United Kingdom, and Arrotex for
Australia and New Zealand.
Beyond these initiatives, we remain actively engaged with potential partners to explore additional
opportunities to accelerate value creation. These efforts include in-licensing, out-licensing, and
other strategic collaboration opportunities.

*

In July 2025, Sanofi publicly announced the completion of its acquisition of Blueprint Medicines Corporation.

19

FINANCIAL INFORMATION
CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER
COMPREHENSIVE INCOME
FOR THE SIX MONTHS ENDED JUNE 30, 2026

NOTES
3

Revenue
Cost of revenue
Gross profit (loss)
Other income
Other gains and losses
Research and development expenses
Selling and marketing expenses
Administrative expenses
Finance costs

4
4

6

Loss for the period
Other comprehensive income:
Item that may be reclassified subsequently to profit or
loss:
Exchange differences arising on translation of foreign
operations
Total comprehensive expenses for the period
Loss per share
– Basic (RMB)

8

– Diluted (RMB)

20

For the six months
ended June 30,
2026
2025
RMB ’ 000
RMB ’ 000
(Unaudited)
(Unaudited)
205,099
(110,900)

49,451
(142,241)

94,199
15,987
(27,383)
(205,532)
(73,114)
(51,316)
(5,125)

(92,790)
9,315
4,566
(105,166)
(35,654)
(43,546)
(6,908)

(252,284)

(270,183)

1,151

269

(251,133)

(269,914)

(0.17)

(0.21)

(0.17)

(0.21)

CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AT JUNE 30, 2026
June 30,
2026
RMB ’ 000
(Unaudited)

December 31,
2025
RMB ’ 000
(Audited)

73,439
16,525
143,847

77,047
6,081
149,687

4,612
9,923

4,759
7,606

248,346

245,180

107,358
65,869
74,174
165,000
1,395,248

33,811
43,792
116,886
165,000
753,699

1,807,649

1,113,188

326,445
170
151,700
10,385
15,922

306,077
2,173
185,900
10,385
5,688

504,622

510,223

Net current assets

1,303,027

602,965

Total assets less current liabilities

1,551,373

848,145

NOTES
Non-current assets
Property, plant and equipment
Right-of-use assets
Intangible assets
Financial assets measured at fair value through profit or
loss (“FVTPL”)
Other receivables

Current assets
Account receivables
Deposits, prepayments and other receivables
Inventories
Time deposits with original maturity over three months
Cash and cash equivalents

Current liabilities
Account and other payables and accrued expenses
Refund liabilities
Bank borrowings
Contract liabilities
Lease liabilities

21

9

10

June 30,
2026
RMB ’ 000
(Unaudited)

December 31,
2025
RMB ’ 000
(Audited)

189,250
69,254
366

156,500
74,447
429

258,870

231,376

Net assets

1,292,503

616,769

Capital and reserves
Share capital
Treasury shares
Treasury shares held in the trusts
Reserves

1,084
(18,627)
(5)
1,310,051

998
–
(3)
615,774

Total equity

1,292,503

616,769

NOTES
Non-current liabilities
Bank borrowings
Contract liabilities
Lease liabilities

22

NOTES
1.

GENERAL AND BASIS OF PREPARATION
The Company is a public limited company incorporated in the Cayman Islands on December 2, 2015 and its
shares are listed on the Main Board of The Stock Exchange since February 26, 2019.
The Company is an investment holding company. The Company’s subsidiaries are principally engaged in
research and development of highly complex biopharmaceutical products and sales of pharmaceutical products.
The condensed consolidated financial statements have been prepared in accordance with International
Accounting Standard 34 Interim Financial Reporting as issued by the International Accounting Standards Board
(“IASB”) as well as the applicable disclosure requirements of the Rules Governing the Listing of Securities on
the Stock Exchange.
The directors of the Company have, at the time of approving the condensed consolidated financial statements,
a reasonable expectation that the Group has adequate resources to continue in operational existence for
the foreseeable future. Thus they continue to adopt the going concern basis of accounting in preparing the
condensed consolidated financial statements.

2.

ACCOUNTING POLICIES
The condensed consolidated financial statements have been prepared on the historical cost basis except for
certain financial instruments, which are measured at fair values, as appropriate.
Other than change in accounting policies resulting from application of amendments to IFRS Accounting
Standards as issued by IASB, the accounting policies and methods of computation used in the condensed
consolidated financial statements for the six months ended June 30, 2026 are the same as those presented in the
Group’s annual consolidated financial statements for the year ended December 31, 2025.
Application of amendments to IFRS Accounting Standards
In the current interim period, the Group has applied the following amendments to IFRS Accounting Standards
as issued by the IASB, for the first time, which are mandatory effective for the Group ’s annual period beginning
on January 1, 2026 for the preparation of the Group’s condensed consolidated financial statements:
Amendments to IFRS 9
and IFRS 7
Amendments to IFRS 9
and IFRS 7
Amendments to IFRS
Accounting Standards

Amendments to the Classification and
Measurement of Financial Instruments
Contracts Referencing Nature-dependent Electricity
Annual Improvements to IFRS Accounting
Standards – Volume 11

The application of the amendment to IFRS Accounting Standards in the current interim period has had no
material impact on the Group’s financial positions and performance for the current and prior periods and/or on
the disclosures set out in these condensed consolidated financial statements.

23

3.

REVENUE
Disaggregation of revenue from contracts with customers
For the six months
ended June 30,
2026
2025
RMB ’ 000
RMB ’ 000
(Unaudited)
(Unaudited)
Type of goods or services
Sales of pharmaceutical products
License fee income
Royalty income

Timing of revenue recognition
A point in time

183,170
6,893
15,036

20,216
17,934
11,301

205,099

49,451

205,099

49,451

Segment Information
The Group has been operating in one reportable segment, being the research and development of highly complex
biopharmaceutical products, the sale of pharmaceutical products and the provision of licenses of its intellectual
property or commercialisation licenses to customers.
The Group’s chief operating decision maker (“CODM”) has been identified as the chief executive officer of
the Group. For the purpose of resource allocation and performance assessment, the CODM reviews the overall
results and financial position of the Group prepared based on the Group’s accounting policies.
Geographical Markets
Substantially the majority of the Group’s operation and non-current assets are located in the People’s Republic
of China (the “ PRC ”). The geographical information of the Group ’s revenue, determined based on the
geographical location of the registered office of the customers, during the reporting period, is as follows:
For the six months
ended June 30,
2026
2025
RMB ’ 000
RMB ’ 000
(Unaudited)
(Unaudited)
Mainland China
Outside Mainland China

24

188,544
16,555

26,942
22,509

205,099

49,451

4.

OTHER INCOME AND OTHER GAINS AND LOSSES
Other income
For the six months
ended June 30,
2026
2025
RMB ’ 000
RMB ’ 000
(Unaudited)
(Unaudited)
Bank and other interest income
Government grants income
Amortization of payments received for exclusive promotion
rights granted
Others

9,380
609

1,087
2,712

5,193
805

5,193
323

15,987

9,315

Other gains and losses
For the six months
ended June 30,
2026
2025
RMB ’ 000
RMB ’ 000
(Unaudited)
(Unaudited)
Net gain on fair value changes of money market funds
Net loss on fair value changes of financial assets measured at FVTPL
Net foreign exchange (loss) gains
Others

25

1,640
(147)
(28,879)
3

136
(2,617)
7,021
26

(27,383)

4,566

5.

INCOME TAX EXPENSE
No income tax expense for the six months ended June 30, 2026 and 2025 as the Group had no assessable profits
derived from the operating entities of the Group.

6.

LOSS FOR THE PERIOD
For the six months
ended June 30,
2026
2025
RMB ’ 000
RMB ’ 000
(Unaudited)
(Unaudited)
Loss for the period has been arrived at after charging (crediting):
Depreciation of
Property, plant and equipment
Right-of-use assets
Amortization of intangible assets

111
16,268
5,840

291
15,964
5,840

Total depreciation and amortization

22,219

22,095

Directors’ emoluments
Other staff costs:
Salaries and other allowances
Performance related bonus
Retirement benefit scheme contributions
Share-based payment expenses

15,205

10,909

38,290
10,893
8,996
13,757

34,523
11,249
7,475
(1,525)

71,936

51,722

87,141

62,631

3,518
(213)
64,339

4,303
64,901
53,181

Impairment losses recognized on construction in progress
(included in research and development expenses)
(Reversal) write-down of inventories (included in cost of revenue)
Cost of inventories recognized as cost of revenue

26

7.

DIVIDENDS
No dividends were paid, declared or proposed during the interim period, nor has any dividend been proposed
since the end of the reporting period.

8.

LOSS PER SHARE
The calculation of the basic and diluted loss per share for the period is as follows:
For the six months
ended June 30,
2026
2025
(Unaudited)
(Unaudited)
Loss (RMB’ 000)
Loss for the period attributable to owners of the Company for
the purpose of basic and diluted loss per share

(252,284)

(270,183)

Number of shares (’ 000)
Weighted average number of ordinary shares for the purpose of
basic and diluted loss per share

1,521,205

1,314,139

The calculation of basic and diluted loss per share for both periods has excluded the treasury shares and treasury
shares held in trust of the Company.
Diluted loss per share for both periods did not assume the exercise of share options awarded under the employee
stock option and the vesting of unvested restricted stock units as their inclusion would be anti-dilutive.
9.

ACCOUNT RECEIVABLES
The Group allows an average credit period of 60 days to its customers.
The following is an aged analysis of account receivables presented based on invoice dates at the end of the
reporting period：

0 – 60 days
61 – 90 days
Over 90 days

27

June 30,
2026
RMB ’ 000
(Unaudited)

December 31,
2025
RMB ’ 000
(Audited)

97,324
2,701
7,333

32,062
–
1,749

107,358

33,811

10.

ACCOUNT AND OTHER PAYABLES AND ACCRUED EXPENSES

Account payables
Other payables and accruals

June 30,
2026
RMB ’ 000
(Unaudited)

December 31,
2025
RMB ’ 000
(Audited)

99,035
227,410

77,201
228,876

326,445

306,077

The credit period on account payables is ranged from 0 to 90 days. The following is an aged analysis of account
payables presented based on invoice dates at the end of the reporting period.

0 – 30 days
31 – 60 days
61 – 90 days
Over 90 days

11.

June 30,
2026
RMB ’ 000
(Unaudited)

December 31,
2025
RMB ’ 000
(Audited)

57,523
18,858
10,795
11,859

52,756
12,481
2,714
9,250

99,035

77,201

EVENTS AFTER THE REPORTING PERIOD
Except as disclosed elsewhere of the condensed consolidated financial statements, no important events affecting
the Company occurred since the end of the reporting period and up to the date of this announcement.

28

FINANCIAL REVIEW
CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER
COMPREHENSIVE INCOME
Six months ended June 30, 2026 compared to six months ended June 30, 2025
For the six months
ended June 30,
2026
2025
RMB ’ 000
RMB ’ 000
(Unaudited)
(Unaudited)
Revenue
Cost of revenue

205,099
(110,900)

49,451
(142,241)

Gross profit (loss)
Other income
Other gains and losses
Research and development expenses
Selling and marketing expenses
Administrative expenses
Finance costs

94,199
15,987
(27,383)
(205,532)
(73,114)
(51,316)
(5,125)

(92,790)
9,315
4,566
(105,166)
(35,654)
(43,546)
(6,908)

Loss for the period

(252,284)

(270,183)

1,151

269

Total comprehensive expense for the period

(251,133)

(269,914)

Non-IFRS measures:
Adjusted loss for the period

(230,915)

(265,099)

Other comprehensive income:
Item that may be reclassified subsequently to profit or loss:
Exchange differences arising on translation of foreign operations

Revenue. Our revenue was RMB205.1 million for the six months ended June 30, 2026,
representing an increase of RMB155.7 million or 315.2% compared to RMB49.4 million for
the six months ended June 30, 2025. The revenue is composed of RMB183.2 million from sales
of pharmaceutical products (avapritinib, pralsetinib and sugemalimab), RMB6.9 million from
license fee income and RMB15.0 million from royalty income of sugemalimab. The substantial
revenue growth was primarily driven by a significant increase in sales of pharmaceutical products,
particularly pralsetinib, following its successful inclusion in the NRDL effective from January
2026, which led to a marked sales ramp-up.
Cost of Revenue. Our cost of revenue was RMB110.9 million for the six months ended June 30,
2026, representing a decrease of RMB31.3 million from RMB142.2 million for the six months
ended June 30, 2025, primarily due to the write-off of inventory write-downs that had been
recognized in 2025 and charged to cost of revenue, as the corresponding inventories were sold
during the current period.

29

Other Income. Our other income increased by RMB6.7 million from RMB9.3 million for the
six months ended June 30, 2025 to RMB16.0 million for the six months ended June 30, 2026,
primarily due to an increase on bank and other interest income.
Other Gains and Losses. Our other gains and losses decreased by RMB32.0 million from a gain of
RMB4.6 million for the six months ended June 30, 2025 to a loss of RMB27.4 million for the six
months ended June 30, 2026, primarily due to a net loss arising from exchange rate fluctuations.
Research and Development Expenses. Our research and development expenses increased by
RMB100.3 million from RMB105.2 million for the six months ended June 30, 2025 to RMB205.5
million for the six months ended June 30, 2026. This increase was primarily attributable to an
increase of RMB86.3 million in milestone fee and third-party contracting cost for clinical trials,
including the Phase II study for CS2009 and for research programs, including CS5006 and CS5007,
from RMB51.3 million for the six months ended June 30, 2025 to RMB137.6 million for the six
months ended June 30, 2026.
For the six months
ended June 30,
2026
2025
’
’
RMB 000
RMB 000
(Unaudited)
(Unaudited)
Milestone fee and third-party contracting cost
Employee cost
Depreciation and others

137,598
50,572
17,362

51,315
35,895
17,956

Total

205,532

105,166

Administrative Expenses. Our administrative expenses increased by RMB7.8 million from
RMB43.5 million for the six months ended June 30, 2025 to RMB51.3 million for the six months
ended June 30, 2026. This increase was primarily attributable to an increase of RMB8.0 million in
employee cost from RMB24.4 million for the six months ended June 30, 2025 to RMB32.4 million
for the six months ended June 30, 2026.
For the six months
ended June 30,
2026
2025
RMB ’ 000
RMB ’ 000
(Unaudited)
(Unaudited)
Employee cost
Professional fees
Depreciation and amortization
Rental expenses
Others

32,418
12,280
2,570
859
3,189

24,359
13,345
2,636
484
2,722

Total

51,316

43,546

30

Selling and Marketing Expenses. Our selling and marketing expenses increased by RMB37.4
million from RMB35.7 million for the six months ended June 30, 2025 to RMB73.1 million for
the six months ended June 30, 2026. This increase was primarily attributable to an increase of
RMB39.6 million in channel service fee and others from RMB33.9 million for the six months
ended June 30, 2025 to RMB73.5 million for the six months ended June 30, 2026.
For the six months
ended June 30,
2026
2025
RMB ’ 000
RMB ’ 000
(Unaudited)
(Unaudited)
Employee cost
Channel service fee and others

(401)
73,515

1,713
33,941

Total

73,114

35,654

Finance Costs. The finance costs decreased by RMB1.8 million from RMB6.9 million for the six
months ended June 30, 2025 to RMB5.1 million for the six months ended June 30, 2026, primarily
due to a decrease in interest on deferred payment arrangement on account payables, following its
settlement in 2025.
Non-IFRS Measures
To supplement the Group’s condensed consolidated financial statements, which are presented in
accordance with the IFRS, the Company also uses adjusted loss for the period and other adjusted
figures as additional financial measures, which are not required by, or presented in accordance
with, the IFRS. The Company believes that these adjusted measures provide useful information
to shareholders and potential investors in understanding and evaluating the Group’s consolidated
results of operations in the same manner as they help the Company’s management.
Adjusted loss for the period represents the loss for the period excluding the effect of certain
noncash items and one-time events, namely the share-based payment expenses. The term adjusted
loss for the period is not defined under the IFRS. The use of this non-IFRS measure has limitations
as an analytical tool, and you should not consider it in isolation from, or as a substitute for analysis
of, the Group’s results of operations or financial condition as reported under IFRS. The Company’s
presentation of such adjusted figures may not be comparable to a similarly titled measure presented
by other companies. However, the Company believes that this and other non-IFRS measures are
reflections of the Group’s normal operating results by eliminating potential impacts of items that
the management do not consider to be indicative of the Group’s operating performance, and thus
facilitate comparisons of operating performance from period to period and company to company to
the extent applicable.

31

The table below sets forth a reconciliation of the loss to adjusted loss during the periods indicated:
For the six months
ended June 30,
2026
2025
RMB ’ 000
RMB ’ 000
(Unaudited)
(Unaudited)
Loss for the period
Added:
Share-based payment expenses

(252,284)

(270,183)

21,369

5,084

Adjusted loss for the period

(230,915)

(265,099)

The table below sets forth a reconciliation of the research and development expenses to adjusted
research and development expenses during the periods indicated:
For the six months
ended June 30,
2026
2025
RMB ’ 000
RMB ’ 000
(Unaudited)
(Unaudited)
Research and development expenses for the period
Added:
Share-based payment expenses

(205,532)

(105,166)

12,173

3,077

Adjusted research and development expenses for the period

(193,359)

(102,089)

The table below sets forth a reconciliation of the administrative and selling and marketing expenses
to adjusted administrative and selling and marketing expenses during the periods indicated:
For the six months
ended June 30,
2026
2025
RMB ’ 000
RMB ’ 000
(Unaudited)
(Unaudited)
Administrative and selling and marketing expenses for the period
Added:
Share-based payment expenses
Adjusted administrative and selling and marketing
expenses for the period

32

(124,430)

(79,200)

9,196

2,007

(115,234)

(77,193)

Employees and Remuneration Policies
The following table sets forth a breakdown of our employees as of June 30, 2026 by function:
Number of
employees

% of total
number of
employees

Research and development
Sales, general and administrative

98
49

66.67
33.33

Total

147

100.00

Function

As of June 30, 2026, we had 102 employees in Shanghai, 10 employees in Beijing, 23 employees in
Suzhou and 12 employees in other regions of the PRC and overseas. Our employees’ remuneration
comprises salaries, bonuses, employee provident fund, social security contributions and other
welfare payments. In accordance with applicable Chinese laws, we have made contributions to
social security insurance funds (including pension plans, medical insurance, work-related injury
insurance, unemployment insurance and maternity insurance) and housing funds for our employees.
Liquidity and Financial Resources
The Group has always adopted a prudent treasury management policy. The Group has taken a
multi-source approach to fund our operations and meet capital requirements for development,
including service and milestone payments and upfront payments from our collaboration partners,
bank borrowings, investments from other third parties, proceeds from our listing on the Stock
Exchange and subsequent equity fundraisings.
For details of the placings and the utilization of their respective proceeds, please refer to the
section headed “Use of Net Proceeds” below.
As of June 30, 2026, our cash and cash equivalents and time deposits were RMB1,560.2 million,
as compared to RMB918.7 million as of December 31, 2025. The cash and cash equivalents were
mainly denominated in RMB, US$ and HK$.
Gearing Ratio
Gearing ratio is calculated using total liabilities divided by total assets and multiplied by 100%. On
June 30, 2026, our gearing ratio was 37.1% (December 31, 2025: 54.6%).
Charge on Assets
As of June 30, 2026, the Group did not pledge any assets (December 31, 2025: Nil).

33

OTHER FINANCIAL INFORMATION
Significant Investments, Material Acquisitions and Disposals
As of June 30, 2026, we did not hold any significant investments, and there had been no material
acquisitions and disposals by the Group. As of the date of this announcement, we have no specific
future plans for material investments or capital assets, as well as for material acquisitions or
disposals of subsidiaries, associates and joint ventures.
Foreign Exchange Risk
Our financial statements are expressed in RMB, but certain of our cash and cash equivalents, time
deposits, other receivables, financial assets measured at FVTPL and trade and other payables are
denominated in foreign currencies, and are exposed to foreign currency risk. We currently do not
have a foreign currency hedging policy. However, the management of the Group monitors foreign
exchange exposure and will consider hedging significant foreign currency exposure should the
need arise.
Bank Loans and Other Borrowings
As of June 30, 2026, the Group’s bank borrowings, all denominated in RMB, amounted to
RMB340,950,000, of which RMB85,000,000 was at fixed interest rates.
Contingent Liabilities
As of June 30, 2026, the Group did not have any material contingent liabilities (December 31,
2025: Nil).
CORPORATE GOVERNANCE AND OTHER INFORMATION
The Company was incorporated in the Cayman Islands with limited liability on December 2, 2015,
and the shares of the Company (the “Shares”) were listed on the Stock Exchange on February 26,
2019.
Compliance with the Corporate Governance Code
The Board is committed to achieving high corporate governance standards. During the Reporting
Period, the Company has complied with all the code provisions as set out in Part 2 of the Corporate
Governance Code (the “CG Code”) contained in Appendix C1 to the Rules Governing the Listing
of Securities on The Stock Exchange of Hong Kong Limited (the “Listing Rules”).
We will continue to regularly review and monitor its corporate governance practices to ensure
compliance with the CG Code, and maintain a high standard of corporate governance practices of
the Company.
Model Code for Securities Transactions by Directors of Listed Issuers
We have adopted our own code of conduct regarding Directors’ securities transactions, namely
the policy on management of securities transactions by directors (the “Securities Transactions
Code”), which applies to all Directors on terms not less exacting than the required standard
indicated by the Model Code for Securities Transactions by Directors of Listed Issuers as set out in
Appendix C3 to the Listing Rules (the “Model Code”).

34

Specific enquiries have been made to all the Directors and they have confirmed that they have
complied with the Securities Transactions Code during the Reporting Period, save as disclosed
below.
During the Reporting Period, in February and March 2026, Dr. Jianxin Yang (“Dr. Yang”), an
executive Director, disposed of an aggregate of 22,127 Shares of the Company on the open market
during the blackout period preceding the release of its 2025 annual results (the “Disposals”). The
Disposals were automatically effected pursuant to the “sell-to-cover” mechanism implemented by
the Company’s share scheme administrator for the purpose of satisfying Dr. Yang’s tax obligations
arising from the vesting of restricted share units granted to him. The Disposals were not intended
to constitute discretionary dealings by Dr. Yang and arose solely from the operation of the
mechanism, and there had been no intention or conduct involving the use of inside information for
trading purposes by Dr. Yang in relation to the Disposals. Following the incident, the Company
has adjusted existing vesting schedules to avoid vesting dates falling within blackout or restricted
dealing periods and will continue to reinforce its compliance procedures and internal monitoring to
ensure ongoing compliance with the Model Code.
The Company ’s employees, who are likely to be in possession of our unpublished inside
information, are subject to the Model Code. No incident of non-compliance of the Model Code by
the employees was noted by the Company as of the date of this results announcement.
Purchase, Sale or Redemption of Listed Securities
During the Reporting Period, the Company repurchased a total of 4,597,000 Shares through the
Stock Exchange, details of which are set out below:

Month

Number
of Shares
purchased

June 2026

4,597,000

Highest price
per Share
(HK$)

Lowest price
per Share
(HK$)

Aggregate
Price Paid
(excluding
expenses)
(HK$)

4.84

4.37

21,356,924.20

All 4,597,000 repurchased Shares were cancelled on July 27, 2026. The purchase of Shares during
the period was effected by the Directors pursuant to the general mandate to repurchase Shares
as approved by the shareholders of the Company at the annual general meetings of the Company
held on June 25, 2025 and June 23, 2026 respectively. These share repurchases demonstrate
the Company’s firm confidence in its long-term business prospects and reflect the Company’s
commitment to prioritizing its shareholders’ returns and continuously optimizing its capital return
framework.
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 (as defined
in the Listing Rules)) during the Reporting Period. As of June 30, 2026, the Company did not hold
any treasury Shares as defined in the Listing Rules.

35

Material Litigation
The Company was not involved in any material litigation or arbitration during the Reporting
Period. The Directors are also not aware of any material litigation or claims that were pending or
threatened against the Group during the Reporting Period.
Material Events after the Reporting Period
Save as disclosed in this results announcement and as of the date of this results announcement,
there were no material events after the Reporting Period.
Use of Net Proceeds
2020 Share Subscription
On September 30, 2020 (before trading hours), the Company entered into the share subscription
agreement with Pfizer Corporation Hong Kong Limited (“Pfizer”), pursuant to which Pfizer has
conditionally agreed to subscribe for an aggregate of 115,928,803 subscription shares (being
ordinary shares of the Company) at the subscription price of HK$13.37 per subscription share
(the closing price of the Company as quoted on the Stock Exchange on September 29, 2020
was HK$9.30 per Share) (the “2020 Share Subscription”). The aggregate nominal value of the
subscription shares under the 2020 Share Subscription is US$11,592,88. Pfizer applies science
and its global resources to improve health and well-being at every stage of life, and was a thirdparty independent of the Company or any of its connected person at the time of the 2020 Share
Subscription. The gross and net proceeds from the allotment and issue of the subscription shares
were approximately US$200.0 million (equivalent to approximately RMB1,355.9 million),
representing a net subscription price of HK$13.37 per subscription share, which will be used to
fund the development activities under the collaboration agreement dated September 30, 2020
entered into among the Company, Pfizer, CStone Pharmaceuticals (Suzhou) Co., Ltd. (基石藥
業(蘇州)有限公司) (“CStone Suzhou”), CStone Pharmaceuticals (Shanghai) Co., Ltd. (拓石藥
業(上海)有限公司) (“CStone Shanghai”) and Pfizer Investment Co. Ltd. (the “Collaboration
Agreement”), where CStone Suzhou and CStone Shanghai are wholly-owned subsidiaries of
the Company. The Company entered into the 2020 Share Subscription and the Collaboration
Agreement to advance the Company ’s strategic, commercial and financial objectives as it
transitions into a fully integrated biopharma company. The closing of the 2020 Share Subscription
took place on October 9, 2020. The use of these proceeds is in line with the planned use, and there
is no significant change.

36

The table below sets out the planned applications of the proceeds from the 2020 Share Subscription
and actual usage up to June 30, 2026:

Fund the development activities under
the Collaboration Agreement

% of use of
proceeds

Net proceeds
from the
subscription
(RMB million)

Unutilized
net proceeds
as of
December 31,
2025
(RMB million)

Actual usage
during
the Reporting
Period
(RMB million)

Unutilized
net proceeds
as of
June 30,
2026
(RMB million)

100%

1,355.9

338.5

24.9

313.6

Note: The unutilized net proceeds are planned to be put into use by December 31, 2027. As disclosed in the 2025
annual report of the Company, the Board had noticed a delay in the planned application of the proceeds from
the 2020 Share Subscription due to changes on clinical development plan in relation to the Collaboration
Agreement. The Board will evaluate and adjust the expected timeline of full utilisation prudently considering
the future development of the Company and market conditions.

April 2025 Placing
On April 2, 2025 (before trading hours), the Company entered into a placing agreement with
Morgan Stanley Asia Limited as the placing agent, pursuant to which the Company agreed to
place, through the placing agent, an aggregate of 80,000,000 placing shares (being ordinary shares
of the Company) to not less than six placees at a price of HK$2.933 per placing share (the closing
price of the Company as quoted on the Stock Exchange on April 1, 2025 was HK$3.45 per Share)
(the “April 2025 Placing”). The net placing price (after deducting related costs and expenses to
be borne by the Company) is approximately HK$2.904 per Share. The aggregate nominal value
of the placing shares under the April 2025 Placing is US$8,000. The placees are professional,
institutional or other investors and, together with their ultimate beneficial owners, are third parties
independent of the Company and any of its connected persons. The April 2025 Placing would
enlarge the Shareholder base and the capital base of the Company, and strengthen the Group’s
financial position for its future development. The net proceeds from the April 2025 Placing,
after deducting the placing commission and other related expenses and professional fees, were
approximately HK$232.29 million (equivalent to approximately RMB215.82 million). The closing
of the April 2025 Placing took place on April 10, 2025. The use of these proceeds is in line with
the planned use, and there is no significant change or delay.

37

The table below sets out the planned applications of the proceeds from the April 2025 Placing and
actual usage up to June 30, 2026:

% of use of
proceeds

Net proceeds
from
the placing
(RMB million)

Unutilized
net proceeds
as of
December 31,
2025
(RMB million)

Actual
usage during
the Reporting
Period
(RMB million)

Unutilized
net proceeds
as of
June 30,
2026
(RMB million)

Research and development of Pipeline
“2.0”, including in particular CS5001, a
clinical stage ROR1 ADC (a potentially
best-in-class ROR1 ADC), and CS2009,
a trispecific antibody targeting PD-1,
VEGFA and CTLA-4 (a potentially firstin-class/best-in-class next-generation
immuno-oncology backbone)
General corporate purposes

90%
10%

194.24
21.58

30.34
0.78

30.34
0.78

–
–

Total

100%

215.82

31.12

31.12

–

July 2025 Placing
On July 8, 2025 (after trading hours), the Company entered into a placing agreement with Morgan
Stanley Asia Limited as the placing agent, pursuant to which the Company agreed to place,
through the placing agent, an aggregate of 100,000,000 placing shares (being ordinary shares of the
Company) to not less than six placees at a price of HK$4.72 per placing share (the closing price of
the Company as quoted on the Stock Exchange on July 8, 2025 was HK$5.18 per Share) (the “July
2025 Placing”). The net placing price (after deducting related costs and expenses to be borne by
the Company) is approximately HK$4.673 per Share. The aggregate nominal value of the placing
shares under the July 2025 Placing is US$10,000. The placees are professional, institutional or
other investors and, together with their ultimate beneficial owners, are third parties independent
of the Company and any of its connected persons. The July 2025 Placing would enlarge the
Shareholder base and the capital base of the Company, and strengthen the Group ’s financial
position for its future development. The net proceeds from the July 2025 Placing, after deducting
the placing commission and other related expenses and professional fees were approximately
HK$467.28 million (equivalent to approximately RMB425.79 million). The closing of the July
2025 Placing took place on July 16, 2025. The use of these proceeds is in line with the planned
use, and there is no significant change or delay.

38

The table below sets out the planned applications of the proceeds from the July 2025 Placing and
actual usage up to June 30, 2026:

% of use of
proceeds

Net proceeds
from
the placing
(RMB million)

Unutilized
net proceeds
as of
December 31,
2025
(RMB million)

Actual
usage during
the Reporting
Period
(RMB million)

Unutilized
net proceeds
as of
June 30,
2026
(RMB million)

73%

310.83

310.83

64.83

246.0

Research and development relating to
CS2009 (Phase II clinical trials and
potential pivotal study) and CS5001
(Phase 1b clinical trials), including
monotherapy and combination therapy
studies
Research and development relating to preclinical assets, including discovery and
PCC of candidates and IND enabling
studies
General corporate purposes (including staff
costs and rental expenses)

17%

72.38

72.38

72.38

–

10%

42.58

42.58

21.75

20.83

Total

100%

425.79

425.79

158.96

266.83

Note: The unutilized net proceeds are planned to be put into use by December 31, 2026.

April 2026 Placing
On April 14, 2026 (after trading hours), the Company entered into a placing agreement with
Goldman Sachs (Asia) L.L.C. as the placing agent, pursuant to which the Company has
conditionally agreed to place, through the placing agent, an aggregate of 118,000,000 placing
shares (being ordinary shares of the Company) to not less than six placees at a price of HK$8.97
per placing share (the closing price of the Company as quoted on the Stock Exchange on April 14,
2026 was HK$9.64 per Share) (the “April 2026 Placing”). The net placing price (after deducting
related costs and expenses to be borne by the Company) is approximately HK$8.9252 per Share.
The aggregate nominal value of the placing shares under the April 2026 Placing is US$11,800.
The placees are professional, institutional or other investors and, together with their ultimate
beneficial owners, are third parties independent of the Company and any of its connected persons.
The April 2026 Placing would enlarge the Shareholder base and the capital base of the Company,
and strengthen the Group’s financial position for its future development. The net proceeds from
the April 2026 Placing, after deducting the placing commission and other related expenses
and professional fees were approximately HK$1,053.17 million (equivalent to approximately
RMB923.0 million). The closing of the April 2026 Placing took place on April 22, 2026. The use
of these proceeds is in line with the planned use, and there is no significant change or delay.

39

The table below sets out the planned applications of the proceeds from the April 2026 Placing and
actual usage up to June 30, 2026:

Research and development relating to CS2009
in Phase II clinical trials with 15 cohorts
exploring monotherapy and combination
therapy studies, and a potential first wave
of Phase III multi-regional clinical trials
(MRCTs)
Research and development relating to CS5001
and pre-clinical assets such as CS5007
(EGFR/HER3 ADC) and other proprietary
ADCs and multi-specific antibodies for
immunology and inflammation diseases
including discovery and PCC of candidates
and IND enabling studies
General corporate purposes (including staff costs
and rental expenses)
Total

% of use of
proceeds

Net proceeds
from
the placing
(RMB million)

Actual
usage during
the Reporting
Period
(RMB million)

Unutilized
net proceeds
as of
June 30,
2026
(RMB million)

60%

553.8

–

553.8

30%

276.9

–

276.9

10%

92.3

–

92.3

100%

923.0

–

923.0

Note: The unutilized net proceeds are planned to be put into use by December 31, 2027.

Audit Committee
The Company has established an audit committee (the “Audit Committee”) with written terms of
reference in accordance with the Listing Rules. The Audit Committee currently comprises three
independent non-executive Directors, namely, Ms. Fang Xie (Chairperson), Mr. Kenneth Howard
Jarrett and Ms. Catherine Yen.
The Audit Committee has considered and reviewed the accounting principles and practices adopted
by the Group and discussed matters in relation to internal control and financial reporting with the
management. The Audit Committee reviewed and considered that the interim financial results for
the six months ended June 30, 2026 are in compliance with the relevant accounting standards, rules
and regulations and appropriate disclosures have been duly made.

40

Review of Interim Results
The independent auditor of the Company, namely Deloitte Touche Tohmatsu, has conducted a
review of the interim financial information in accordance with International Standard on Review
Engagements 2410 Review of Interim Financial Information Performed by the Independent Auditor
of the Entity as issued by the International Auditing and Assurance Standards Board. The Audit
Committee has jointly reviewed with the management of the Company, the accounting principles
and practices adopted by the Group and discussed internal control and financial reporting matters
(including the review of the unaudited interim results for the six months ended June 30, 2026) of
the Group.
INTERIM DIVIDEND
The Board does not recommend the payment of an interim dividend for the six months ended June
30, 2026 (2025: Nil).
PUBLICATION OF INTERIM RESULTS ANNOUNCEMENT AND INTERIM REPORT
This announcement is published on the websites of the Stock Exchange (www.hkexnews.hk ) and
the Company (www.cstonepharma.com ).
The interim report for the six months ended June 30, 2026 containing all the information required
by Appendix D2 to the Listing Rules will be published on the websites of the Stock Exchange and
the Company in due course.
APPRECIATION
The Board would like to express its sincere gratitude to the shareholders, management team,
employees, business partners and customers of the Group for their support and contribution to the
Group.
By Order of the Board
CStone Pharmaceuticals
Dr. Wei Li
Chairman
Suzhou, the People’s Republic of China, August 27, 2026

As of the date of this announcement, the Board comprises Dr. Wei Li as Chairman and nonexecutive director, Dr. Jianxin Yang as executive director, Mr. Kenneth Walton Hitchner III and
Mr. Edward Hu as non-executive directors, and Mr. Kenneth Howard Jarrett, Ms. Fang Xie and
Ms. Catherine Yen as independent non-executive directors.

41

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倚
賴該等內容而引致的任何損失承擔任何責任。

CStone Pharmaceuticals
基石藥業

（於開曼群島註冊成立的有限公司）

（股份代號：2616）

截至二零二六年六月三十日止六個月中期業績公告
基石藥業（「本公司」或「基石藥業」）董事（「董事」）會（「董事會」）欣然宣佈，本公
司及其附屬公司（統稱「本集團」或「我們」）截至二零二六年六月三十日止六個月
（「報告期間」）的未經審核綜合業績，連同截至二零二五年六月三十日止六個月的
比較數字。

財務摘要
國際財務報告準則（「國際財務報告準則」）計量：
•

收入由截至二零二五年六月三十日止六個月的人民幣49.4百萬元增加人民幣
155.7百萬元或315.2%至截至二零二六年六月三十日止六個月的人民幣205.1
百萬元。收入包括藥品銷售（阿伐替尼、普拉替尼及舒格利單抗）人民幣183.2
百萬元、授權費收入人民幣6.9百萬元及舒格利單抗特許權使用費收入人民幣
15.0百萬元。收入的大幅增長主要由藥品（尤其是普拉替尼）的銷售額顯著增
加所帶動，此乃由於該藥物自二零二六年一月起成功納入國家醫保藥品目錄
（「國家醫保目錄」），從而帶動銷量顯著上升。

•

收入成本由截至二零二五年六月三十日止六個月的人民幣142.2 百萬元減少
人民幣31.3百萬元至截至二零二六年六月三十日止六個月的人民幣110.9百萬
元，主要由於撇銷曾於二零二五年確認並計入收入成本的存貨撇減，原因是
相關存貨已於本期間售出。

•

研發開支由截至二零二五年六月三十日止六個月的人民幣105.2百萬元增加人
民幣100.3百萬元至截至二零二六年六月三十日止六個月的人民幣205.5百萬
元，乃主要由於有關臨床試驗（包括CS2009的II期研究）及其他研究項目（包
括CS5006及CS5007）的第三方合約成本增加。

1

•

行政開支由截至二零二五年六月三十日止六個月的人民幣43.5百萬元增加人
民幣7.8百萬元至截至二零二六年六月三十日止六個月的人民幣51.3百萬元，
主要由於僱員成本增加。

•

銷售及市場推廣開支由截至二零二五年六月三十日止六個月的人民幣35.7百
萬元增加人民幣37.4百萬元至截至二零二六年六月三十日止六個月的人民幣
73.1百萬元，乃主要歸因於渠道服務費增加。

•

期內虧損由截至二零二五年六月三十日止六個月的人民幣270.2百萬元減少虧
損人民幣17.9百萬元至截至二零二六年六月三十日止六個月的人民幣252.3百
萬元，乃主要歸因於由毛損轉為毛利，部分被研發開支及銷售及市場推廣開
支增加所抵銷。

•

現金及現金等價物及定期存款截至二零二六年六月三十日為人民幣1,560.2百
萬元。

非國際財務報告準則（「非國際財務報告準則」）計量：
•

扣除以股份為基礎的付款開支後，研發開支由截至二零二五年六月三十日止
六個月的人民幣102.1百萬元增加人民幣91.3百萬元至截至二零二六年六月三
十日止六個月的人民幣193.4百萬元，乃主要由於有關臨床試驗（包括CS2009
的II期研究）及其他研究項目（包括CS5006 及CS5007）的第三方合約成本增
加。

•

扣除以股份為基礎的付款開支後，行政以及銷售及市場推廣開支由截至二零
二五年六月三十日止六個月的人民幣77.2百萬元增加人民幣38.0百萬元至截
至二零二六年六月三十日止六個月的人民幣115.2百萬元，乃主要由於渠道服
務費及僱員成本增加。

•

扣除以股份為基礎的付款開支後，期內虧損由截至二零二五年六月三十日止
六個月的人民幣265.1百萬元減少虧損人民幣34.2百萬元至截至二零二六年六
月三十日止六個月的人民幣230.9百萬元，乃主要歸因於由毛損轉為毛利，部
分被研發開支及銷售及市場推廣開支增加所抵銷。

2

業務摘要
截至二零二六年六月三十日止六個月及直至本業績公告日期，基石藥業在自有管
線2.0產品組合及商業產品線方面均取得重大進展，持續推進本公司打造全面一體
化、具備全球競爭力的生物製藥企業的戰略。主要成就概述如下：
臨床階段核心資產

•

CS2009，PD-1/VEGF/CTLA-4三特異性抗體
－ 加速全球臨床開發，目標於二零二六年底前啟動III期註冊試驗
正在進行的全球 I 期（劑量遞增）╱I I 期（擴展）試驗已在中國及澳大利
亞入組超過 300 例患者，並於二零二六年二月獲得美國新藥臨床試驗
（「IND」）許可。該研究採用多隊列、平行擴展設計，旨在評估CS2009作
為單藥及聯合方案的安全性、耐受性、藥代動力學（「PK」）、藥效動力學
（「PD」）及初步療效。
基石藥業計劃於二零二六年底前啟動CS2009首批全球III期多區域臨床試
驗（「MRCT」）。計劃開展的註冊研究包括：聯合化療用於非小細胞肺癌
（「NSCLC」）一線治療（對比帕博利珠單抗聯合化療），以及聯合化療用
於轉移性結直腸癌（「mCRC」）一線治療（對比貝伐珠單抗聯合化療），並
計劃於二零二七年及其後年份進行額外的註冊研究。

－ CS2009持續驗證其作為下一代I/O骨幹藥物的潛力
於二零二六年美國臨床腫瘤學會（「ASCO」）年會（「二零二六年ASCO年
會」）上，基石藥業展示了正在進行中的全球多中心試驗之綜合I/II期數
據。截至二零二六年八月數據截止日期，CS2009 正在進行中的全球I/II
期試驗的更新單藥治療療效數據（具有較二零二六年ASCO年會所呈列數
據更長的隨訪期）持續顯示其於多種腫瘤類型中具備強勁且不斷深化的
抗腫瘤活性。基於逾300名患者的數據，已取得三項重要關鍵臨床驗證：
•

安全性驗證
在所有劑量水平下，均未觀察到劑量限制性毒性（「DLT」），且尚
未 達 到 最 大 耐 受 劑 量（「 M T D 」）。 於 二 零 二 六 年 A S C O 年 會 數 據
中，三級或以上治療相關不良事件（「TRAE」）及免疫相關不良事
件（「irAE」）的發生率分別為24.6%及12.7%。值得注意的是，三級
或以上VEGF相關TRAE的發生率僅為5.1%。未觀察到CTLA-4/PD(L)1聯合用藥常見的過度毒性。截至二零二六年八月，CS2009的安
全性特徵與於二零二六年ASCO年會所呈列者維持一致，且未發現
新的安全性信號。
3

•

CTLA-4活性與療效驗證
觀察到CD4+ T細胞上的ICOS呈劑量依賴性上調，作為CTLA-4阻斷
的藥效動力學生物標誌物。在對PD-(L)1 單抗不敏感的「冷腫瘤」中
亦觀察到活性：

•

－

用於mCRC後線單藥治療(30 mg/kg)：客觀緩解率（「ORR」）為
20.0%(3/15)，疾病控制率（「DCR」）為93.3%(14/15)。

－

用於軟組織肉瘤（「STS」）後線單藥治療：ORR為38.5%(5/13)，
DCR為69.2%(9/13)。

－

用於非透明細胞腎細胞癌（「nccRCC」）後線單藥治療：ORR為
42.9%(3/7)，DCR為100.0%(7/7)。

－

於 腫 瘤 免 疫（「 I O 」）治 療 後 的 N S C L C 後 線 單 藥 治 療 中 ， 展
現 出 具 潛 力 的 抗 腫 瘤 活 性 ：O R R 為 2 3 . 8 % ( 5 / 2 1 ) ， D C R 為
61.9%(13/21)。在先前已接受免疫治療以及含鉑化療的患者中
(n=13)，ORR為38.5%(5/13)，DCR為84.6%(11/13)。

廣泛療效驗證
於一線及後線NSCLC中顯示出單藥治療及聯合化療的活性：
－

一線NSCLC單藥治療（PD-L1 腫瘤比例分數（「TPS」）≥1%；入
組已完成）：ORR為61.7%(29/47)，DCR為93.6%(44/47)，其
中，接受30 mg/kg治療的患者中ORR為70.8% (17/24)，DCR
為91.7% (22/24)；於PD-L1 TPS ≥50%組別（n=24）中，ORR為
83.3%(20/24)，DCR為95.8%(23/24)（ 相比二零二六年ASCO數
據截止時ORR為81.3%(13/16)），其中於接受30 mg/kg治療的
患者中，ORR為100.0%(11/11)，DCR為100.0%(11/11)。經過6
個月的中位隨訪後，中位無進展生存期（「PFS」）及DOR尚未達
到。

－

二線或以上NSCLC單藥治療(30mg/kg)：ORR為28.0%(7/25)，
D C R 為 6 0 . 0 % ( 1 5 / 2 5 ) ， 六 個 月 D O R 率 為 8 3 . 3 %（ 相 比 二 零
二六年ASCO年會數據截止時ORR為24.0%，六個月DOR
率 為 8 0 . 0 % ）。 在 所 有 已 評 估 劑 量 水 平（ n = 5 4 ）中 ， O R R 為
16.7%(9/54)，DCR為68.5%(37/54)，六個月DOR率為87.5%（相
比二零二六年ASCO年會數據截止時為85.7%）。
4

－

後 線 N S C L C（ 二 線 ╱ 三 線 聯 合 治 療 ， n = 6 ）： O R R 為
66.7%(4/6)，DCR 為 100.0%(6/6)。該數據為截至二零二六年
ASCO數據截止日期的數據，其將於二零二六年歐洲腫瘤內科
學會（「ESMO」）大會（「二零二六年ESMO大會」）予以更新。

－

一線鱗狀NSCLC聯合治療（PD-L1低表達 ╱ 陰性，TPS ≤5%，
n=8）：ORR為75.0%(6/8)，DCR為100.0%(8/8)；值得注意的
是，於PD-L1 陰性亞組中，ORR 達100.0%(4/4)。該數據為截
至二零二六年ASCO數據截止日期的數據，其將於二零二六年
ESMO大會予以更新。

於一線mCRC聯合化療中顯示出強勁的療效，患者大多為錯配修復
功能完整或微衛星穩定型（「pMMR/MSS」）：
－

一線mCRC（聯合XELOX，n=6）：ORR為66.7%(4/6)，DCR為
100.0%(6/6)。該數據為截至二零二六年ASCO數據截止日期的
數據，其將於二零二六年ESMO大會予以更新。

於轉移性去勢抵抗性前列腺癌（「mCRPC」）、卵巢癌、三陰性乳腺
癌、胃癌、子宮內膜癌，以及STS及nccRCC中均觀察到具潛力的單
藥治療活性。

－ CS2009將於二零二六年ESMO大會進行兩項口頭報告
CS2009的臨床研究結果已獲接納於二零二六年ESMO大會作兩項快速口
頭報告。該等報告將展示CS2009在晚期NSCLC及mCRC患者中的I/II期
臨床數據。

5

其他臨床階段資產

•

CS5007, EGFR/HER3 ADC
－ 推動基石藥業自有ADC平台進入臨床階段
本公司於二零二六年六月啟動I期首次人體研究。該試驗包括劑量遞增和
劑量擴展隊列，旨在評估CS5007單藥治療晚期實體瘤患者的效果，並將
同時在澳大利亞和中國開展。基石藥業已在二零二六年美國癌症研究協
會（「AACR」）年會上公佈了CS5007的臨床前數據，進一步佐證其廣譜抗
腫瘤潛力。
CS5007進入臨床階段，亦標誌著基石藥業自有抗體偶聯藥物（「ADC」）
平台取得關鍵里程碑，拓寬了下一代管線2.0的治療模態。

商業化產品

•

擇捷美 ®（舒格利單抗），抗PD-L1抗體
－ 全球監管拓展及納入ESMO指南
繼 舒 格 利 單 抗 在 歐 盟（「 歐 盟 」）及 英 國（「 英 國 」）首 次 獲 批 用 於 I V 期
NSCLC後，舒格利單抗於二零二五年十一月在歐盟、隨後於二零二六
年二月在英國獲得額外批准，作為不可切除III 期 NSCLC（含鉑放化療
（「CRT」）後未發生疾病進展）成人患者的單藥治療。與此同時，舒格利
單抗的上市許可申請已獲全球近30個國家批准或正在積極審評中。
於二零二六年三月，擇捷美 ®（舒格利單抗）被納入《ESMO早期及局部晚
期NSCLC動態臨床指南》。舒格利單抗獲[I, A]級推薦，用於同步或序貫
放化療後未出現疾病進展的不可切除III期NSCLC患者的鞏固治療。

－ 通過戰略聯盟達成第五項國際商業化合作
於二零二六年六月，基石藥業與 A r r o t e x P h a r m a c e u t i c a l s P t y L t d
（「Arrotex」）簽訂獨家商業化協議。Arrotex是澳大利亞最大的私有製藥
公司，在澳大利亞及新西蘭擁有成熟的腫瘤學商業化能力和分銷基礎設
施。這一里程碑將舒格利單抗的全球商業化網絡拓展至五項戰略合作夥
伴關係，覆蓋歐洲、中東、非洲、拉丁美洲及大洋洲等逾60個國家和地
區。
6

•

普拉替尼膠囊，RET抑制劑
－ 納入國家醫保目錄及商業化加速增長
繼普拉替尼膠囊(100 mg)於二零二五年底納入中國國家醫保目錄（自二零
二六年一月一日起生效）後，患者可及性顯著提升。截至二零二六年七
月止七個月期間，普拉替尼的市場銷量按年增長近500%。

－ 地產化生產獲批助力商業規模化擴展
繼中國國家藥品監督管理局（「NMPA」）批准普拉替尼膠囊(100 mg)地產
化申請後，首批國產普拉替尼已於二零二六年在中國上市。
臨床前 ╱IND申報階段項目：

•

均衡且差異化的早期產品組合，橫跨腫瘤及免疫 ╱ 炎症領域
基石藥業的臨床前管線2.0涵蓋多特異性抗體、ADC及其他下一代治療模態的
創新候選藥物，在腫瘤、免疫、炎症及其他高價值治療領域具備潛在同類首
創（「FIC」）或同類最優（「BIC」）的機會。
本公司自有的ADC 平台整合了優化的連接子技術，旨在實現腫瘤選擇性載
荷釋放，並支持多個管線2.0 ADC候選藥物，包括CS5007（雙靶向表皮生長
因子受體（「EGFR」）及人表皮生長因子受體3（「HER3」）雙特異性ADC）、
CS5006（整合素 β4（「ITGB4」）ADC）及 CS5008（δ 樣配體 3（「DLL3」）及
SSTR2雙特異性ADC）等。本公司亦已開發專有的下一代ADC平台，包括雙
載荷ADC（如CS5009，一款B7H3/PD-L1雙特異性雙載荷ADC；及CS5010，
一款雙表位靶向HER2 的雙載荷ADC）及新型載荷ADC（如CS5012，一款雙
表位靶向HER2的新型載荷ADC）。二零二六年四月，基石藥業在二零二六年
AACR年會上公佈了CS5007、CS5006及CS5008的臨床前數據，突顯其下一
代ADC管線的廣度與差異化優勢。
在腫瘤領域之外，基石藥業憑藉其自有多特異性抗體平台，已將管線2.0拓展
至免疫及炎症領域。本公司已開發出靶向2型炎症性疾病的CS2015（OX40L/
TSLP 雙特異性抗體）、靶向 B 細胞介導自身免疫性疾病的 CS2013（BAFF/
APRIL雙特異性抗體）、CS2016（TL1A/α4β7雙特異性抗體）及CS1016（PD-1
激動劑抗體）。

7

未來及願景
我們的使命是透過卓越的科學和技術創新，提供革命性的療法，讓全世界都能獲
得高品質的治療，造福患者及其家屬。
我們重申我們的承諾，即透過優化內部開發能力和持續的研發投資，推進強大且
與眾不同的管線，同時維持戰略合作夥伴關係以發揮我們上市產品的全球價值。
二零二六年下半年的關鍵驅動力包括：
•

•

臨床里程碑
－

通過推進與全球監管機構（包括美國食品藥品監督管理局（「FDA」））就III
期註冊試驗設計進行溝通，以加速CS2009的全球開發，計劃於二零二六
年年底前啟動首批全球III期MRCT，同時繼續尋求建立全球合作夥伴關
係。

－

推進CS5007（EGFR/HER3 雙特異性ADC）、CS5006(ITGB4 ADC)、
CS5008(SSTR2/DLL3 ADC)及其他早期候選藥物的臨床開發。

創新與技術
－

進一步加強自有技術平台，包括多特異性抗體及下一代ADC技術，以支
持臨床前管線的持續擴展。

－

在國際頂級學術會議上公佈關鍵臨床數據（包括CS2009的更新數據），其
中包括於二零二六年ESMO大會上發表兩項有關CS2009 I/II期數據的快
速口頭報告。

根據上市規則第18A.08(3)條作出的警示聲明：我們可能無法最終成功開發
或銷售任何管線產品。

8

管理層討論及分析
我們的願景
以創新為驅動，成為改善全球患者健康的引領者。

概覽
基石藥業（香港聯交所代碼：2616）成立於二零一五年底，是一家專注於腫瘤學、
免疫與炎症及其他關鍵疾病領域藥物研發的創新型生物製藥公司。自成立以來，
本公司致力於滿足中國和全球患者的殷切醫療需求，並取得了重大進展。迄今為
止，本公司已成功上市4款創新藥，並獲得涵蓋9個適應症的21項新藥申請批准。
當前研發管線均衡配置了16 款極具潛力的候選藥物，其中包括潛在FIC或BIC的
ADC、多特異性抗體、免疫療法及精準治療藥物。同時，基石藥業亦擁有一支具
有豐富經驗和能力的管理團隊，覆蓋從臨床前探索、臨床轉化、臨床開發、藥物
生產、商務擴展和商業運營等關鍵環節。有關上述任何詳情，請參閱本業績公告
的其餘部分，以及（如適用）於香港聯合交易所有限公司（「聯交所」）及本公司網站
刊登的招股章程及過往公告。
戰略框架及商業模式
我們的戰略核心是透過在全球範圍內推進管線2.0 以實現可持續增長，並最大限
度地提高我們已上市產品的生命週期價值。我們透過資本效益高、輕資產的模式
執行此策略，將內部資源優先聚焦於核心競爭力：早期發現、轉化科學及臨床開
發。憑藉與領先的合約研究機構（「CRO」）及合約開發與製造機構（「CDMO」）建
立的合作夥伴關係，我們得以在確保科學嚴謹性不受影響的前提下保持營運靈活
性。我們透過在主要地區市場建立戰略合作夥伴關係來推動商業化，從而擴大患
者覆蓋範圍並推動收入增長，同時保持對創新的高度專注。展望未來，我們將繼
續加強我們的研究及臨床能力，推進高潛力資產進入後期開發階段，並採取量身
定制的全球合作戰略，以最大限度地提高我們的商業產品組合及管線的價值。

9

產品管線
以下管線圖顯示截至本業績公告日期，我們所選資產的里程碑及開發狀況：
–商業化階段/ 後期臨床項目
管線藥物

適應症

概念驗證

關鍵研究

新藥上市申請

上市

各地獲批狀態
CN

TW

HK

US

EU

UK

合作夥伴

合作領域

一線NSCLC
二線NSCLC
普拉替尼 (RET)

 中國大陸

NSCLC
TC
多種腫瘤
PDGFRA外顯子18突變*,67

阿伐替尼 (KIT/PDGFRA)

PDGFRA D842V突變*,67
 中國大陸

惰性系統性肥大細胞增多症1
侵襲性系統性肥大細胞增多症1
一線IV期NSCLC

 中國大陸
 瑞士及中東歐地區

III期NSCLC
舒格利單抗 (PD-L1)

 中東及非洲

一線G/GEJ

 拉丁美洲

一線ESCC

 西歐與英國
 澳大利亞與新西蘭

復發/難治ENKTL
CS1002 (CTLA- 4)

實體瘤

 大中華區

CN =中國大陸，TW = 中國台灣，HK = 中國香港，US = 美國，EU = 歐盟，UK = 英國，NSCLC = 非小細胞肺癌，TC = 甲狀腺癌，GIST = 胃腸道間質瘤，G/GEJ = 胃腺癌╱胃食管結合部腺癌，ESCC = 食管鱗癌，ENKTL = 結外NK/T細胞淋巴瘤
1.概念驗證研究在北美和歐洲完成。在中國尚未開展臨床試驗，IND申請籌備中

－ 研發管線2.0
商業權利

適應症

藥物發現

臨床前開發

新藥臨床試驗申請

首次人體試驗

概念驗證試驗

抗體（腫瘤領域）
CS2009 （PD-1/VEGF/CTLA-4 三特異性抗體）

實體瘤

CS1012（GDF-15 單抗）

實體瘤

ADC（腫瘤領域）
CS5001 （ROR1 ADC）
1

實體瘤、血液瘤

CS5007 （EGFR/HER3 雙特異性ADC）

實體瘤

CS5006 （ITGB4 ADC）

實體瘤

CS5008（SSTR2/DLL3 雙特異性ADC）

實體瘤

CS5009 （B7H3/PD-L1 雙特異性雙毒素ADC）

實體瘤

CS5010 （HER2 雙表位雙毒素ADC）

實體瘤

CS5012 （HER2 雙表位新型毒素ADC）

實體瘤

抗體（免疫與炎症領域）
CS2013 （BAFF/APRIL 雙特異性抗體）

免疫與炎症

CS2015 （OX40L/TSLP 雙特異性抗體）

免疫與炎症

CS1016 （PD-1 激動劑抗體）

免疫與炎症

CS2016 （TL1A/α4β7 雙特異性抗體）

免疫與炎症
全球權益

註： 所示產品的進展為「商業權利」一欄標注地區的進展
1.

基石從LigaChem Biosciences, Inc. (LCB)獲得獨家主導LCB71/CS5001在韓國境外開發和商業化的全球權利

10

業務回顧
商業產品
為推動全球增長戰略，我們積極與領先的製藥及生物科技公司建立戰略夥伴關
係。截至本業績公告日期，我們已在全球主要市場建立多項商業合作。這些聯盟
旨在通過運用合作夥伴的既有能力、專業知識與市場影響力，提升我們商業化工
作的效率與可擴展性。該策略不僅加速我們於戰略性國際市場的拓展，同時也使
我們能集中內部資源推進核心研發管線。
我們的商業產品組合的詳情載於下文：

•

擇捷美 ®（舒格利單抗，抗PD-L1抗體）在中國、歐盟和英國獲批，並正於全
球逾60個國家及地區推進商業化拓展
－

作為一種全人源全長抗PD-L1單克隆抗體，由基石藥業基於OmniRat ® 轉
基因動物平台開發的舒格利單抗是一種最接近人體的天然G型免疫球蛋
白4（「IgG4」）單抗藥物，潛在能降低在患者體內產生免疫原性及相關毒
性的風險。

－

多項適應症獲全球監管機構批准，印證其臨床價值。
中國國家藥監局已批准舒格利單抗五項適應症：
•

IV期NSCLC：聯合培美曲塞和卡鉑用於EGFR基因突變陰性和間變
性淋巴瘤激酶（「ALK」）陰性的轉移性非鱗狀NSCLC患者的一線治
療；聯合紫杉醇和卡鉑用於轉移性鱗狀NSCLC患者的一線治療；

•

III期NSCLC：作為單一療法，用於治療同步或序貫含鉑放化療後未
出現疾病進展的、不可切除、III期NSCLC患者；

•

R/R ENKTL：作為單一療法，用於治療復發或難治性（「R/R」）結外
自然殺傷細胞 ╱T細胞淋巴瘤（「ENKTL」）的成人患者；

•

ESCC：聯合含鉑和氟尿嘧啶類化療藥物一線治療不可切除的局部晚
期，復發或轉移性食管鱗狀細胞癌（「ESCC」）患者；及

•

G/GEJ 腺癌：聯合含氟尿嘧啶類和鉑類藥物化療用於 PD-L1 表達
（CPS≥5）的不可手術切除的局部晚期或轉移性胃及胃食管結合部
（「G/GEJ」）腺癌的一線治療。
11

歐盟委員會（「EC」）及英國藥品和醫療保健用品管理局（「MHRA」）已批
准舒格利單抗用於兩項適應症：

－

•

IV期NSCLC：擇捷美 ® 聯合含鉑化療適用於無EGFR敏感突變，或無
ALK，ROS1或RET基因組腫瘤變異的轉移性NSCLC成人患者的一
線治療；及

•

III期NSCLC：擇捷美 ® 單藥療法適用於治療無EGFR敏感突變，或
無ALK、ROS1基因組腫瘤變異，腫瘤細胞PD-L1表達≥1%，並在接
受含鉑放化療後未出現疾病進展的不可切除的、III期NSCLC成人患
者。

通過第五次戰略合作擴展至大洋洲
於二零二六年六月，我們與Arrotex訂立獨家商業化協議，擬於澳大利亞
及新西蘭將該資產商業化。該里程碑建立在先前合作的基礎之上 － 即二
零二四年至二零二五年間，我們先後與Ewopharma AG（「Ewopharma」）、
Pharmalink Store LLC OPC（「Pharmalink」）、Laboratorios Stein
S.A.（「SteinCares」）及Istituto Gentili S.R.L.（「Gentili」）達成的合作。通過
該等合作，舒格利單抗的商業版圖已擴展至歐洲、中東及非洲、拉丁美洲
以及大洋洲等逾60個國家及地區。

－

ESMO指南[I, A]級推薦與學術認可
•

ESMO指南推薦：二零二六年三月，舒格利單抗獲《ESMO早期及
局部晚期NSCLC動態臨床指南》
(ESMO Early and Locally Advanced
NSCLC Living Guideline)[I, A]級推薦，用於EGFR野生型、無ALK
或ROS1腫瘤基因突變的不可切除III期NSCLC患者在同步或序貫放
化療後未進展者的鞏固治療。該推薦預計將顯著推動舒格利單抗在
歐盟及其他地區的市場准入，擴大可及患者範圍，從而強化其全球
商業化佈局。
此前，二零二五年二月，舒格利單抗聯合化療亦獲《歐洲腫瘤內科
學會非驅動基因陽性轉移性非小細胞肺癌動態臨床指南》( E S M O
Non-Oncogene-Addicted Metastatic NSCLC Living Guideline)[I, A]級
推薦，用於鱗狀及非鱗狀轉移性（IV期）NSCLC的一線治療。迄今，
舒格利單抗在歐盟及英國獲批的兩項NSCLC適應症均已納入ESMO
指南，進一步印證其獲認可的臨床價值。

12

•

•

*

學術發表與會議亮相：此外，舒格利單抗多項研究的臨床數據已數
十次榮登國際權威同行評審醫學期刊及頂尖學術會議，包括《柳葉
刀•腫瘤學》
(The Lancet Oncology)、《自然•癌症》
(Nature Cancer)、
《美國醫學會雜誌》
(JAMA)、ESMO大會及ASCO大會。持續的學術
認可彰顯了舒格利單抗臨床證據的紮實實力，及其在全球腫瘤學界
日益提升的認知度。

普拉替尼膠囊（RET抑制劑）與Allist合作：納入國家醫保目錄與商業增長
－

普拉替尼膠囊（中國首款轉染重排（「RET」）抑制劑），已獲中國國家藥品
監督管理局批准，用於局部晚期或轉移性RET融合陽性NSCLC成人患者
的治療。此外，該藥已獲香港特區政府衛生署（「香港衛生署」）批准，用
於治療RET融合陽性局部晚期或轉移性NSCLC患者；並獲台灣食品藥品
監督管理局（「TFDA」）批准，用於治療局部晚期或轉移性RET融合陽性
NSCLC成人患者，以及晚期或轉移性RET融合陽性甲狀腺癌(TC)成人患
者。該藥（GAVRETO ®）亦獲美國FDA批准，用於經FDA批准檢測方法
確認為轉移性RET融合陽性NSCLC的成人患者；以及需要系統性治療、
年齡≥12歲的晚期或轉移性RET融合陽性甲狀腺癌成人和兒童患者，且其
對放射性碘難治（如適用放射性碘）*。

－

於二零二六年，我們持續將普拉替尼膠囊整合至Allist高度協同的肺癌產
品線，使該產品受益於Allist成熟的商業化團隊及廣泛的市場覆蓋，同時
得以降低普拉替尼商業化相關的運營成本，提升整體盈利能力。

－

二零二五年十二月，普拉替尼膠囊(100 mg)被納入中國國家醫療保障局
發佈的最新版國家醫保目錄。更新後的國家醫保目錄於二零二六年一月
一日起正式實施。截至二零二六年七月止七個月期間，普拉替尼的市場
銷量按年增長近500%。

－

繼二零二五年七月中國國家藥品監督管理局批准普拉替尼膠囊(100 mg)
地產化申請後，我們於二零二六年五月成功生產並上市首批國產批
次。供應鏈正逐步從進口產品過渡至端到端的國產化生產 － 從原料藥
（「API」）到製劑成品。這一戰略性轉變顯著提升了成本效益與供應鏈韌
性。

該適應症基於ORR和DOR數據，在加速審批途徑下獲得批准。針對該適應症的持續批准
可能取決於確證性試驗中臨床獲益的驗證與描述。
13

－

•

普拉替尼膠囊已被納入中國11項國家級檢測與治療指南，覆蓋NSCLC等
多個治療領域。二零二三年，普拉替尼獲《二零二三年中國臨床腫瘤學
會（「CSCO」）NSCLC診療指南》推薦，該指南推薦RET突變基因檢測及
普拉替尼用於RET陽性NSCLC患者的治療。二零二四年，《二零二四年
CSCO NSCLC診療指南》將普拉替尼治療IV期RET融合陽性NSCLC的推
薦級別提升至I級推薦。

阿伐替尼片劑（KIT/PDGFRA抑制劑）與恒瑞建立合作夥伴關係：保障國產
化供應並續列國家醫保目錄
－

阿伐替尼片劑，同類首創KIT/PDGFRA 抑制劑，已獲中國國家藥監局
批准用於治療攜帶PDGFRA外顯子18突變（包括PDGFRA D842V突變）
的不可切除或轉移性胃腸道間質瘤（「GIST」）成人患者。阿伐替尼獲香
港衞生署及TFDA批准用於治療攜帶PDGFRA D842V突變的不可切除
或轉移性GIST成人患者。阿伐替尼亦已獲美國FDA批准用於治療三種
適應症，具體為：攜帶PDGFRA外顯子18 突變（包括PDGFRA D842V
突變）的不可切除性或轉移性GIST成人患者；晚期系統性肥大細胞增多
症（晚期SM）成人患者包括侵襲性SM（「ASM」）、伴有血液腫瘤的SM
（「SM-AHN」）和肥大細胞白血病（「MCL」），以及惰性系統性肥大細胞
增多症（「ISM」）成人患者。該藥物（商品名AYVAKYT ®）亦已在歐洲批
准上市，用於治療攜帶PDGFRA D842V突變不可切除或轉移性GIST成
人患者，至少經一次系統全身治療後的患有ASM、SM-AHN及MCL以及
症狀中重度且對症狀治療控制不佳的ISM成人患者。

－

於二零二四年七月，我們與江蘇恒瑞醫藥股份有限公司（「恒瑞」）就阿
伐替尼片劑在中國大陸的獨家推廣權建立商業合作夥伴關係。阿伐替
尼（300mg及100mg）的地產化申請已獲中國國家藥監局於二零二四年批
准，其後於二零二五年二月開始國產供應，且毛利率大幅提升。

－

我們不斷提高阿伐替尼片劑的可及性及可負擔性。繼於二零二三年十二
月首次納入後，阿伐替尼於二零二五年十二月成功續列國家醫保目錄，
用於治療攜帶PDGFRA外顯子18突變（包括PDGFRA D842V突變）的不
可切除或轉移性GIST成人患者。最新的國家醫保目錄已於二零二六年一
月一日生效。

－

阿伐替尼片劑獲若干權威指南推薦，包括CSCO胃腸道間質瘤診療指南
（二零二五年版）、CSCO胃腸道間質瘤診療指南（二零二二年版）及中國
成人系統性肥大細胞增多症診療指南（二零二二年版）。

14

臨床階段核心產品

CS2009（PD-1/VEGF/CTLA-4三特異性抗體）：最新全球I/II期臨床數據進一步驗
證其作為下一代I/O骨幹藥物的潛力，並助力其全球開發策略
•

CS2009 為本公司管線2.0 項下的核心資產，是由基石藥業自主研發的具FIC/
BIC潛力的PD-1/VEGF/CTLA-4三特異性抗體。CS2009通過同時靶向三條經
臨床驗證的通路，即PD-1、VEGFA及CTLA-4，旨在透過多重作用機制實現
協同抗腫瘤活性。具體而言，阻斷PD-1可恢復T細胞效應功能，阻斷CTLA-4
可促進T 細胞活化及增殖，而阻斷VEGFA 則可抑制腫瘤血管生成並重塑腫
瘤微環境（「TME」）。在TME中，CS2009 的抗PD-1 及抗CTLA-4 活性通過
與VEGFA的交聯而顯著增強；同時，其基於親合力效應而優先結合PD-1及
CTLA-4雙陽性腫瘤浸潤T細胞（包括效應T細胞及調節性T細胞），從而增強
其結合親和力及檢查點抑制活性。在外周系統中，CS2009 具單價、低親和
力的CTLA-4臂無法有效阻斷CTLA-4單陽性T細胞上的CTLA-4/CD80相互作
用，因而可避免該等細胞被過度活化，並降低全身性自身免疫毒性的風險。
與傳統PD-1/CTLA-4聯合療法相比，此差異化機制旨在擴大治療窗口。

•

CS2009 全球多中心II期擴展研究的患者入組工作正積極進行。此項多隊列
平行擴展研究旨在評估 C S2009 單藥及聯合療法的療效、安全性、耐受性
及PK/PD特徵，涵蓋12 個實體瘤適應症共19 個研究隊列，該等適應症包括
NSCLC、CRC、廣泛期小細胞肺癌（「ES-SCLC」）、宮頸癌（「CC」）、GC/
GEJC、ESCC、鉑類耐藥卵巢癌（「PROC」）、三陰性乳腺癌（「TNBC」）、
HCC、胰腺癌、腎細胞癌（「RCC」）及MSI-H實體瘤。

•

於二零二六年二月取得美國 IND 批准後，本公司正就與美國 FDA 溝通，籌
備臨床安全性及療效數據集，以及化學、製造和控制（「CMC」）方面的準
備工作，以就擬開展的首批全球III 期 MRCT 設計達成一致，目標於二零二
六年底前啟動，包括CS2009 聯合化療對比帕博利珠單抗聯合化療用於一線
NSCLC，以及CS2009聯合化療對比貝伐珠單抗聯合化療用於一線mCRC等。
本公司亦持續就潛在全球合作事宜與全球製藥公司進行深入討論。

•

於二零二六年ASCO年會上，基石藥業展示了正在進行中的全球多中心試驗
之綜合I/II期數據。CS2009於多種腫瘤類型中展現出廣譜抗腫瘤活性、良好
的安全性及耐受性特徵，以及令人鼓舞的PK/PD特性。
在所有劑量水平下，均未觀察到DLT，且尚未達到MTD。三級或以上TRAE
及irAE的發生率分別為24.6%及12.7%。值得注意的是，三級或以上VEGF相
關TRAE僅見於5.1%的患者。未觀察到PD-(L)1及CTLA-4聯合用藥常見的過
度毒性。
15

於二零二六年ASCO所呈列的CS2009廣譜抗腫瘤活性概述如下。單藥治療的
最新數據（截至二零二六年八月的數據截止日期）將於後文討論；此處所呈列
數據涉及聯合療法。
－

一線NSCLC
P D - L1 低表達 ╱ 陰性（T P S ≤5%）鱗狀 N S C L C + 化療（n =8）：O R R
為 75.0% (6/8)，D C R 為 100.0% (8/8)；於 P D - L1 陰性亞組中，O R R 達
100.0%(4/4)。

－

後線NSCLC
二線 ╱ 三線聯合療法（n=6）：ORR為66.7%(4/6)，DCR為100.0%(6/6)。

－

mCRC
一線XELOX聯合療法（n=6）：ORR為66.7%(4/6)，DCR為100.0%(6/6)。

•

截至二零二六年八月數據截止日期，CS2009正在進行中的全球I/II期試驗之
單藥治療最新療效數據反映，較二零二六年ASCO展示時有更長的隨訪期，
並持續顯示其於多種腫瘤類型中強勁且不斷加深的抗腫瘤活性。可評估患者
界定為至少接受一次基線後腫瘤評估的患者：
－

於一線NSCLC單藥治療隊列（PD-L1 TPS ≥1%，每三週一次（「Q3W」），
2 0 或 3 0 m g / k g； 入 組 已 完 成 ）中 ， 共 評 估 4 7 名 可 評 估 患 者 ：O R R 為
61.7%(29/47)，DCR為93.6%(44/47)，其中，接受 30 mg/kg治療的患
者中 ORR 為 70.8% (17/24)，DCR 為 91.7% (22/24)；鱗狀疾病及非鱗
狀疾病均觀察到一致活性，當中鱗狀疾病的 ORR為60.7%(17/28)、
DCR為96.4%(27/28)，而非鱗狀疾病的ORR為63.2%(12/19)、DCR為
89.5%(17/19)。於PD-L1 TPS ≥50%組別（24名可評估患者）中，ORR為
83.3%(20/24)，DCR為95.8%(23/24)，其中30 mg/kg治療患者的ORR為
100.0%(11/11)、DCR為100.0%(11/11)，而20 mg/kg治療患者的ORR為
69.2%(9/13)、DCR為92.3%(12/13)。經過6個月的中位隨訪後，中位PFS
及DOR尚未達到。

－

於二線或以上NSCLC單藥治療隊列中，在25 名接受30 mg/kg治療的可
評估患者中，ORR為28.0%(7/25)，DCR為60.0%(15/25)，六個月DOR率
為83.3%。於曾接受免疫治療加含鉑雙藥化療的患者（n=13）中，ORR為
38.5%(5/13)，DCR為84.6%(11/13)。在所有已評估劑量水平（N=54）中，
ORR為16.7%(9/54)，DCR為68.5%(37/54)，六個月DOR率為87.5%。
16

－

於後線mCRC單藥治療隊列(30 mg/kg)中，共評估15名可評估患者，且大
部分屬pMMR/MSS疾病：ORR為20.0%(3/15)，DCR為93.3%(14/15)。

－

於後線STS單藥治療隊列中，共評估13名可評估患者：ORR為38.5%(5/13)
，DCR為69.2%(9/13)。

－

於後線nccRCC單藥治療隊列中，共評估7名可評估患者：ORR為42.9%(3/7)
，DCR為100.0%(7/7)。

CS2009的安全性特徵與於二零二六年ASCO年會所呈列者維持一致，且未發
現新的安全性信號。

•

CS2009的臨床研究結果已獲接納於二零二六年ESMO大會作兩項快速口頭報
告。該等報告將展示CS2009在晚期NSCLC及mCRC患者中的I/II期臨床數據。

其他臨床階段產品

CS5001（LCB71，ROR1 ADC）
•

CS5001是一款以ROR1為靶點的臨床階段ADC。CS5001使用腫瘤特異激活的
吡咯並苯二氮卓（pyrrolobenzodiazepine，「PBD」）前毒素載荷(payload)和連
接子(linker)，並已在一線及二線瀰漫性大B細胞淋巴瘤（「DLBCL」）中展現
出強效的抗腫瘤活性。申辦方暫時停止試驗，以評估現有臨床數據的長期獲
益與風險，並優化劑量及給藥方案。

•

截至二零二六年八月，CS5001與R-CHOP的聯合療法於一線DLBCL中展現出
廣泛且深度的緩解。於40-90 μ g/kg劑量水平（n=31）下，ORR為100%，且於
各劑量水平的完全緩解（「CR」）率均為100%。

17

CS5007 (EGFR/HER3 ADC): 基石藥業專有ADC平台賦能潛在同類最優分子，啟
動全球I期臨床試驗
•

CS5007 出自基石藥業自主開發的專有ADC技術平台，為一款靶向EGFR及
HER3的雙特異性ADC，旨在解決腫瘤異質性，並有望克服與單靶點療法相
關的耐藥機制。於二零二六年AACR公佈的臨床前數據顯示，其具有出色的
血漿穩定性、在納摩爾濃度下具備強效的抗原依賴性細胞毒性，且對多種腫
瘤類型（包括NSCLC、CRC、乳腺癌（「BC」）、SCCHN及SCC）展現出廣譜的
抗腫瘤活性。其在奧希替尼耐藥腫瘤、EGFR低表達腫瘤等難治適應症的細
胞系來源異種移植（「CDX」）模型中展現出令人鼓舞的活性。CS5007展現出
優異的PK/PD特徵，且半衰期延長。GLP毒理研究確定其最高非嚴重毒性劑
量（「HNSTD」）為30 mg/kg，具有較寬的治療窗口。

•

CS5007 的全球多中心I期臨床試驗於二零二六年六月在澳洲啟動，且其IND
申請於二零二六年八月根據創新藥臨床試驗審批通道獲國家藥監局批准。該
試驗為一項首次人體研究，包含劑量遞增及劑量擴展隊列，以評估CS5007單
藥治療用於接受標準治療後疾病進展、不符合標準治療條件或缺乏有效治療
方案的晚期實體瘤患者。該研究旨在評估CS5007的安全性、耐受性、藥代動
力學及初步抗腫瘤活性，同時確立RP2D。該試驗在澳大利亞和中國同步開
展，加速全球臨床開發節奏。

CS1002（SHR-8068，抗CTLA-4抗體）：與恒瑞在大中華區建立戰略合作夥伴關
係並正在推進III期試驗
•

二零二一年十一月，我們與恒瑞訂立獨佔許可協議，據此，恒瑞獲得CS1002/
SHR-8068在大中華地區研發、註冊、生產和商業化的獨佔授權。基石藥業保
留CS1002在大中華地區以外地區的開發和商業化權利。

•

恒瑞已啟動六項關鍵性臨床試驗，以評價CS1002/SHR-8068聯合其他療法在
多種實體瘤適應症中的療效，包括晚期或轉移性非鱗狀NSCLC的一線治療、
晚期或轉移性NSCLC的一線治療、局部晚期可切除直腸癌的圍手術期治療、
不可治癒HCC、晚期HCC的一線治療及晚期膽道癌（「BTC」）的一線治療。此
外，恒瑞亦正推進多項II期研究，以評價CS1002/SHR-8068聯合療法在其他
實體瘤中的療效，包括可切除NSCLC及HCC的圍手術期治療、CRC、RCC、
G/GEJ腺癌等。

18

臨床前 ╱IND申報階段候選藥物
本公司致力於開拓下一代療法，包括多特異性抗體、ADC及其他創新療法。此
外，本公司已將其早期研究項目擴展至免疫學、炎症及其他關鍵治療領域。憑藉
其全球開發能力，基石藥業致力於透過國際多中心臨床開發推進該等差異化資
產，以加速全球創新並擴大患者的藥物可及性。
主要管線進展包括：
•

自有專有ADC技術平台：基石藥業正積極推進下一代ADC技術，包括旨在提
高系統穩定性、腫瘤選擇性及治療窗口的創新連接子技術。本公司特有的串
聯可裂解β－ 葡萄糖醛酸連接子技術展現出以下潛在優勢：
－

親水性增強，提高分子整體的循環穩定性。

－

透過串聯裂解機制實現腫瘤選擇性載荷釋放。

－

與馬來酰亞胺功能基團的半隨機偶聯已通過臨床驗證，具有可製造性。

該專有ADC平台旨在優化ADC的安全性及有效性特徵、拓寬靶點兼容性，並支
持基石藥業管線2.0下多個ADC候選藥物的開發，包括CS5006 (ITGB4 ADC)、
CS5007（EGFR/HER3雙特異性ADC）及CS5008（DLL3/SSTR2雙特異性ADC）。
本公司亦已開發專有的下一代ADC平台，包括雙載荷ADC（例如CS5009，一款
B7H3/PD-L1雙特異性雙載荷ADC；及CS5010，一款雙表位靶向HER2的雙載荷
ADC）及新型載荷ADC（例如CS5012，一款雙表位靶向HER2的新型載荷ADC）。
值得注意的是，CS5006、CS5007及CS5008的臨床前數據已於二零二六年AACR
年會上公佈，而CS5007（EGFR/HER3雙特異性ADC）的全球I期臨床試驗已於二
零二六年六月啟動。

19

•

•

其他ADC管線候選藥物
－

CS5006 (ITGB4 ADC)：CS5006 是一款潛在的同類首創 ADC，靶向
全新泛癌靶點整合素 β4(ITGB4)。ITGB4 是一種跨膜蛋白，僅與整合
素 α6(ITGA6) 結合形成 α6β4 異二聚體。體外和體內研究均顯示出支持
其臨床開發的有力證據。此分子針對廣泛的適應症，包括 NSCLC、
SCCHN、CRC等。

－

CS5008(SSTR2/DLL3 ADC)：CS5008為一款使用基石藥業專有的抗體
和連接子載荷靶向 SSTR2/DLL3 的新型雙特異性 ADC。通過同時靶向
NEN、SCLC及其他惡性腫瘤中頻繁共表達的SSTR2與DLL3，CS5008旨
在克服單靶點療法固有的腫瘤異質性挑戰。

擴展至免疫及炎症領域
除腫瘤學外，基石藥業利用其專有的多特異性抗體平台，將管線2.0擴展至免
疫及炎症領域。本公司已開發多款潛在的同類首創 ╱ 同類最優雙特異性抗體
候選藥物，在風濕病學、腎臟病學、呼吸病學、胃腸病學、皮膚病學等免疫
介導疾病中具有廣泛的治療潛力。
－

CS2013，一款 BAFF/APRIL 雙特異性抗體，靶向 B 細胞介導的自身免
疫性疾病，包括但不限於系統性紅斑狼瘡（「SLE」）、類風濕性關節炎
（「RA」）及IgA腎病（「IgAN」）。

－

CS1016，一款識別 PD-1 近膜表位的 PD-1 激動劑抗體，研究發現其可
清除高水平表達PD-1 的病理性T細胞，旨在應對由Y細胞驅動的免疫疾
病，包括RA及銀屑病關節炎（「PsA」）等。

20

－

CS2015，一款靶向OX40L及TSLP的雙特異性抗體，旨在透過雙重抑制
參與Th2介導炎症反應的關鍵調節因子，治療2型炎症疾病，包括但不限
於特應性皮炎、哮喘及慢性阻塞性肺病。

－

CS2016（TL1A/α4β7雙特異性抗體），一款靶向TL1A及α4β7的雙特異性
抗體，旨在阻斷涉及炎症性腸病（「IBD」）的兩種關鍵蛋白。

候選藥物預計將向IND申報邁進，這代表基石藥業戰略性擴展至腫瘤學以外、具
有重大未滿足醫療需求的高價值治療領域的重要里程碑。

上市規則第18A.08(3)條規定的警示聲明：我們最終未必能成功開發或推出
我們的任何管線產品。
商務拓展及戰略合作關係
我們的商務拓展團隊在推動本公司的戰略成長目標方面扮演著重要的角色。其工
作重點為擴展已上市產品的商業化、利用潛在的同類首創及同類最優資產強化
我們的臨床階段管線，以及收購創新技術。截至本業績公告日期，我們已與輝
瑞、賽諾菲 ∗、恒瑞、三生制药、艾力斯、Ewopharma、Pharmalink、SteinCares、
Gentili及Arrotex等行業領導者建立戰略合作夥伴關係。
就我們在中國大陸的已上市產品而言，我們於二零二三年十一月與艾力斯就普拉
替尼膠囊訂立獨家商業化協議，並於二零二四年七月與恒瑞就阿伐替尼片建立戰
略合作夥伴關係。根據該兩項安排，本公司保留在相關地區的所有其他權利，包
括開發、註冊、製造及分銷權利。
就擇捷美 ®（舒格利單抗）的全球商業化而言，我們繼續在主要國際市場擴展戰
略合作夥伴網絡。該等合作包括與 Ewopharma 在瑞士及 18 個中東歐（「CEE」）
市場的合作、與Pharmalink在中東及北非（「MENA」）地區以及南非的合作、與
SteinCares在拉丁美洲（「LATAM」）的合作、與Gentili在西歐及英國的合作，以及
與Arrotex在澳洲及新西蘭的合作。
除該等舉措外，我們仍積極與潛在合作夥伴探討其他機會，以加速創造價值。該
等工作包括內部授權、外部授權及其他戰略合作機會。

∗

二零二五年七月，賽諾菲公開宣佈完成對Blueprint Medicines Corporation的收購。
21

財務資料
簡明綜合損益及其他全面收益表
截至二零二六年六月三十日止六個月

附註
收入
收入成本

3

毛利（損）
其他收入
其他收益及虧損
研發開支
銷售及市場推廣開支
行政開支
融資成本

4
4

期內虧損

6

其他全面收入：
其後可重新分類至損益的項目：
換算海外業務產生的匯兌差額
期內全面開支總額
每股虧損
－ 基本（人民幣元）

8

－ 攤薄（人民幣元）

22

截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核）
（未經審核）
205,099
(110,900)

49,451
(142,241)

94,199
15,987
(27,383)
(205,532)
(73,114)
(51,316)
(5,125)

(92,790)
9,315
4,566
(105,166)
(35,654)
(43,546)
(6,908)

(252,284)

(270,183)

1,151

269

(251,133)

(269,914)

(0.17)

(0.21)

(0.17)

(0.21)

簡明綜合財務狀況表
於二零二六年六月三十日

附註
非流動資產
物業、廠房及設備
使用權資產
無形資產
按公平值計量且其變動計入損益
（「按公平值計量且其變動計入損益」）
的金融資產
其他應收款項

二零二六年
二零二五年
六月三十日 十二月三十一日
人民幣千元
人民幣千元
（未經審核）
（經審核）

73,439
16,525
143,847

77,047
6,081
149,687

4,612
9,923

4,759
7,606

248,346

245,180

107,358
65,869
74,174
165,000
1,395,248

33,811
43,792
116,886
165,000
753,699

1,807,649

1,113,188

326,445
170
151,700
10,385
15,922

306,077
2,173
185,900
10,385
5,688

504,622

510,223

流動資產淨值

1,303,027

602,965

總資產減流動負債

1,551,373

848,145

流動資產
應收賬款
按金、預付款項及其他應收款項
存貨
原到期日超過三個月的定期存款
現金及現金等價物

流動負債
應付賬款及其他應付款項及應計開支
退款負債
銀行借款
合約負債
租賃負債

9

10

23

附註
非流動負債
銀行借款
合約負債
租賃負債

二零二六年
二零二五年
六月三十日 十二月三十一日
人民幣千元
人民幣千元
（未經審核）
（經審核）

189,250
69,254
366

156,500
74,447
429

258,870

231,376

資產淨值

1,292,503

616,769

資本及儲備
股本
庫存股
以信託形式持有的庫存股
儲備

1,084
(18,627)
(5)
1,310,051

998
–
(3)
615,774

總權益

1,292,503

616,769

24

附註
1.

一般資料及編製基準
本公司為一間於二零一五年十二月二日在開曼群島註冊成立的上市有限公司，其股份自二
零一九年二月二十六日起於聯交所主板上市。
本公司為投資控股公司。本公司的附屬公司主要從事高度複雜的生物製藥產品的研發及藥
品銷售。
簡明綜合財務報表乃根據國際會計準則理事會（「國際會計準則理事會」）頒佈的國際會計
準則第34號中期財務報告 及聯交所證券上市規則的適用披露規定編製。
本公司董事於批准本簡明綜合財務報表時持合理預期相信本集團有足夠資源於可見未來繼
續營運。因此，彼等於編製本簡明綜合財務報表時繼續採用持續經營之會計基準。

2.

會計政策
簡明綜合財務報表乃按歷史成本基準編製，惟若干按公平值計量較為適合之金融工具除外
（如適用）。
除應用國際會計準則理事會頒佈的經修訂國際財務報告準則會計準則導致之會計政策變動
外，截至二零二六年六月三十日止六個月之簡明綜合財務報表所用會計政策及計算方法與
本集團截至二零二五年十二月三十一日止年度之年度綜合財務報表內所呈列者相同。
採用經修訂國際財務報告準則會計準則
於本中期期間，本集團於編製本集團的簡明綜合財務報表時，已首次應用由國際會計準則
理事會頒佈的以下經修訂國際財務報告準則會計準則，其於本集團二零二六年一月一日開
始的年度期間強制生效：
國際財務報告準則第9號及國際財務
報告準則第7號修訂本
國際財務報告準則第9號及國際財務
報告準則第7號修訂本
國際財務報告準則會計準則修訂本

金融工具的分類及計量修訂
涉及倚賴自然能源生產電力之合約
國際財務報告準則會計準則的年度
改進 － 第11卷

於當前中期期間應用該等經修訂國際財務報告準則會計準則對本集團於當前及過往期間的
財務狀況及表現及 ╱ 或該等簡明綜合財務報表所載的披露概無重大影響。

25

3.

收入
客戶合約收入的細分
截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核）
（未經審核）
貨品或服務類型
銷售藥品
授權費收入
特許權使用費收入

確認收入的時間
於某一時間點

183,170
6,893
15,036

20,216
17,934
11,301

205,099

49,451

205,099

49,451

分部資料
本集團的經營一貫只有一個可報告分部，即高度複雜的生物製藥產品的研發、銷售藥品及
向客戶提供其知識產權授權或商業化授權。
本集團的主要經營決策者（「主要經營決策者」）乃本集團的首席執行官。為進行資源分配
及表現評估，主要經營決策者會審閱本集團根據本集團會計政策編製的整體業績及財務狀
況。
地區市場
本集團大部分營運及非流動資產均位於中華人民共和國（「中國」）。報告期內本集團收入的
地區資料根據客戶註冊辦事處的地區位置釐定如下：
截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核）
（未經審核）
中國大陸
中國大陸以外

26

188,544
16,555

26,942
22,509

205,099

49,451

4.

其他收入及其他收益及虧損
其他收入
截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核）
（未經審核）
銀行及其他利息收入
政府補貼收入
就已授出獨家推廣權而收取的款項攤銷
其他

9,380
609
5,193
805

1,087
2,712
5,193
323

15,987

9,315

其他收益及虧損
截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核）
（未經審核）
貨幣市場基金公平值變動收益淨額
按公平值計量且其變動計入損益的金融資產
公平值變動虧損淨額
外匯（虧損）收益淨額
其他

5.

1,640

136

(147)
(28,879)
3

(2,617)
7,021
26

(27,383)

4,566

所得稅開支
由於本集團於其經營實體中概無產生應課稅溢利，故截至二零二六年及二零二五年六月三
十日止六個月並無所得稅開支。

27

6.

期內虧損
截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核）
（未經審核）
期內虧損已扣除（計入）以下各項：
折舊：
物業、廠房及設備
使用權資產
無形資產攤銷

111
16,268
5,840

291
15,964
5,840

折舊及攤銷總額

22,219

22,095

董事酬金
其他員工成本：
薪金及其他津貼
業績獎金
退休福利計劃供款
以股份為基礎的付款開支

15,205

10,909

38,290
10,893
8,996
13,757

34,523
11,249
7,475
(1,525)

71,936

51,722

87,141

62,631

3,518
(213)
64,339

4,303
64,901
53,181

在建工程確認之減值虧損（計入研發開支）
存貨（撥回）撇減（計入收入成本）
確認為收入成本之存貨成本

7.

股息
於中期期間並無派付、宣派或擬派股息，自報告期末以來亦無擬派股息。

28

8.

每股虧損
期內每股基本及攤薄虧損的計算方法如下：
截至六月三十日止六個月
二零二六年
二零二五年
（未經審核）
（未經審核）
虧損（人民幣千元）
用於計算每股基本及攤薄虧損的本公司
擁有人應佔期內虧損

(252,284)

(270,183)

股份數目（千股）
用於計算每股基本及攤薄虧損的普通股
加權平均數

1,521,205

1,314,139

兩個期間內每股基本及攤薄虧損的計算並不包括庫存股及本公司以信託形式持有的庫存
股。
兩個期間內的每股攤薄虧損並無假設行使根據僱員持股計劃授出的購股權及歸屬未歸屬的
受限制股份單位，因其計入將產生反攤薄影響。

9.

應收賬款
本集團授予其客戶的平均信貸期為60天。
於報告期末，本集團根據發票日期呈報的應收賬款賬齡分析如下：
二零二六年
二零二五年
六月三十日 十二月三十一日
人民幣千元
人民幣千元
（未經審核）
（經審核）
0至60天
61至90天
超過90天

29

97,324
2,701
7,333

32,062
–
1,749

107,358

33,811

10. 應付賬款及其他應付款項及應計開支
二零二六年
二零二五年
六月三十日 十二月三十一日
人民幣千元
人民幣千元
（未經審核）
（經審核）
應付賬款
其他應付及應計款項

99,035
227,410

77,201
228,876

326,445

306,077

應付賬款的信貸期為0至90天。於報告期末，下列為根據發票日期呈報的應付賬款賬齡分
析。
二零二六年
二零二五年
六月三十日 十二月三十一日
人民幣千元
人民幣千元
（未經審核）
（經審核）
0至30天
31至60天
61至90天
超過90天

57,523
18,858
10,795
11,859

52,756
12,481
2,714
9,250

99,035

77,201

11. 報告期後的事項
除簡明綜合財務報表其他處所披露者外，自報告期末起直至本公告日期，概無發生影響本
公司的重大事項。

30

財務回顧
簡明綜合損益及其他全面收益表
截至二零二六年六月三十日止六個月與截至二零二五年六月三十日止六個月比較
截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核） （未經審核）
收入
收入成本

205,099
(110,900)

49,451
(142,241)

毛利（損）
其他收入
其他收益及虧損
研發開支
銷售及市場推廣開支
行政開支
融資成本

94,199
15,987
(27,383)
(205,532)
(73,114)
(51,316)
(5,125)

(92,790)
9,315
4,566
(105,166)
(35,654)
(43,546)
(6,908)

期內虧損

(252,284)

(270,183)

1,151

269

期內全面開支總額

(251,133)

(269,914)

非國際財務報告準則計量：
期內經調整虧損

(230,915)

(265,099)

其他全面收入：
其後可重新分類至損益的項目：
換算海外業務產生的匯兌差額

收入。 我們的收入由截至二零二五年六月三十日止六個月的人民幣49.4 百萬元
增加人民幣155.7百萬元或315.2%至截至二零二六年六月三十日止六個月的人民
幣205.1 百萬元。收入包括藥品銷售（阿伐替尼、普拉替尼及舒格利單抗）人民幣
183.2百萬元、授權費收入人民幣6.9百萬元及舒格利單抗特許權使用費收入人民
幣15.0 百萬元。收入大幅增長主要受藥品（特別是普拉替尼）銷售顯著增加所帶
動，該產品成功獲納入國家醫保目錄（自二零二六年一月起生效），從而帶動銷售
顯著攀升。
31

收入成本。 我們的收入成本由截至二零二五年六月三十日止六個月的人民幣142.2
百萬元減少人民幣 31.3 百萬元至截至二零二六年六月三十日止六個月的人民幣
110.9百萬元，主要由於撇銷已於二零二五年確認並計入收入成本的存貨撇減，此
乃由於相關存貨已於本期間售出。
其他收入。 我們的其他收入由截至二零二五年六月三十日止六個月的人民幣9.3百
萬元增加人民幣6.7百萬元至截至二零二六年六月三十日止六個月的人民幣16.0百
萬元，主要由於銀行及其他利息收入增加所致。
其他收益及虧損。 我們的其他收益及虧損由截至二零二五年六月三十日止六個月
的收益人民幣4.6百萬元減少人民幣32.0百萬元至截至二零二六年六月三十日止六
個月的虧損人民幣27.4百萬元，主要由於匯率波動產生的淨虧損所致。
研發開支。 我們的研發開支由截至二零二五年六月三十日止六個月的人民幣105.2
百萬元增加人民幣100.3 百萬元至截至二零二六年六月三十日止六個月的人民幣
205.5百萬元。該增加乃主要歸因於有關臨床試驗（包括CS2009的II期研究）及研
究項目（包括CS5006及CS5007）的里程碑費用及第三方合約成本由截至二零二五
年六月三十日止六個月的人民幣51.3百萬元增加人民幣86.3百萬元至截至二零二
六年六月三十日止六個月的人民幣137.6百萬元。
截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核） （未經審核）
里程碑費用及第三方合約成本
僱員成本
折舊及其他

137,598
50,572
17,362

51,315
35,895
17,956

合計

205,532

105,166

32

行政開支。 我們的行政開支由截至二零二五年六月三十日止六個月的人民幣43.5
百萬元增加人民幣7.8百萬元至截至二零二六年六月三十日止六個月的人民幣51.3
百萬元。該增加乃主要由於僱員成本由截至二零二五年六月三十日止六個月的人
民幣24.4百萬元增加人民幣8.0百萬元至截至二零二六年六月三十日止六個月的人
民幣32.4百萬元所致。
截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核） （未經審核）
僱員成本
專業費用
折舊及攤銷
租賃開支
其他

32,418
12,280
2,570
859
3,189

24,359
13,345
2,636
484
2,722

合計

51,316

43,546

銷售及市場推廣開支。 我們的銷售及市場推廣開支由截至二零二五年六月三十日
止六個月的人民幣35.7百萬元增加人民幣37.4百萬元至截至二零二六年六月三十
日止六個月的人民幣73.1百萬元。該增加主要是由於渠道服務費及其他由截至二
零二五年六月三十日止六個月的人民幣33.9百萬元增加人民幣39.6百萬元至截至
二零二六年六月三十日止六個月的人民幣73.5百萬元。
截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核） （未經審核）
僱員成本
渠道服務費及其他

(401)
73,515

1,713
33,941

合計

73,114

35,654

融資成本。 融資成本由截至二零二五年六月三十日止六個月的人民幣6.9百萬元減
少人民幣1.8百萬元至截至二零二六年六月三十日止六個月的人民幣5.1百萬元，
乃主要由於應付賬款延期付款安排的利息隨着其於二零二五年結算而減少。
33

非國際財務報告準則計量
為補充本集團按照國際財務報告準則呈列的簡明綜合財務報表，本公司亦使用並
非國際財務報告準則規定或按其呈列的期內經調整虧損以及其他經調整數字作為
附加財務計量。本公司認為該等經調整計量為股東及潛在投資者提供有用信息，
使其與本公司管理層採用的相同方式瞭解並評估本集團的綜合經營業績。
期內經調整虧損指未計若干非現金項目及一次性事件影響的期內虧損，即以股份
為基礎的付款開支。國際財務報告準則並未對期內經調整虧損一詞進行界定。使
用該非國際財務報告準則計量作為分析工具具有局限性， 閣下不應視其為獨立於
或可代替本集團根據國際財務報告準則所呈報的經營業績或財務狀況的分析。本
公司對有關經調整數字的呈列未必可與其他公司所呈列的類似計量指標相比。然
而，本公司認為，此及其他非國際財務報告準則計量可通過消除管理層認為不能
反映本集團經營表現的項目的潛在影響，反映本集團的正常經營業績，從而有助
於在適用限度內比較不同期間及不同公司的經營表現。
下表載列於所示期間虧損與經調整虧損的對賬：
截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核） （未經審核）
期內虧損
加：
以股份為基礎的付款開支

(252,284)

(270,183)

21,369

5,084

期內經調整虧損

(230,915)

(265,099)

34

下表載列於所示期間研發開支與經調整研發開支的對賬：
截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核） （未經審核）
期內研發開支
加：
以股份為基礎的付款開支

(205,532)

(105,166)

12,173

3,077

期內經調整研發開支

(193,359)

(102,089)

下表載列於所示期間行政及銷售以及市場推廣開支與經調整行政及銷售以及市場
推廣開支的對賬：
截至六月三十日止六個月
二零二六年
二零二五年
人民幣千元
人民幣千元
（未經審核） （未經審核）
期內行政及銷售以及市場推廣開支
加：
以股份為基礎的付款開支

(124,430)

(79,200)

9,196

2,007

期內經調整行政及銷售以及市場推廣開支

(115,234)

(77,193)

35

僱員及薪酬政策
下表載列截至二零二六年六月三十日我們按職能劃分的僱員明細：

僱員人數

佔僱員
總人數%

研發
銷售、一般及行政

98
49

66.67
33.33

總計

147

100.00

職能

截至二零二六年六月三十日，我們在上海擁有 102 名僱員，在北京擁有 10 名僱
員，在蘇州擁有23名僱員，在中國其他地區及海外擁有12名僱員。我們的僱員薪
酬包括薪金、花紅、僱員公積金、社會保險供款及其他福利付款。根據中國適用
法律，我們為僱員的社保基金（包括養老金計劃、醫療保險、工傷保險、失業保
險及生育保險）及住房公積金作出供款。
流動資金及財務資源
本集團一直採取審慎的資金管理政策。本集團已採取多來源方法為其營運提供資
金並滿足發展對資本的需求，包括來自合作夥伴的服務費、里程碑付款及預付
款、銀行貸款、來自其他第三方的投資、於聯交所上市的所得款項及後續股本融
資。
有關配售事項及其各自所得款項用途的詳情，請參閱下文「所得款項淨額用途」一
節。
截至二零二六年六月三十日，我們的現金及現金等價物及定期存款為人民幣
1,560.2百萬元，而截至二零二五年十二月三十一日為人民幣918.7百萬元。現金及
現金等價物主要以人民幣、美元和港元計值。
資產負債比率
資產負債比率採用總負債除以總資產再乘以100%計算。於二零二六年六月三十
日，我們的資產負債比率為37.1%（二零二五年十二月三十一日：54.6%）。

36

資產押記
截至二零二六年六月三十日，本集團並無抵押任何資產（二零二五年十二月三十
一日：無）。

其他財務資料
重大投資、重大收購及出售事項
截至二零二六年六月三十日，我們並無持有任何重大投資，本集團亦無任何重大
收購及出售事項。截至本公告日期，我們並無重大投資或資本資產相關的具體未
來計劃，亦無計劃進行重大收購或出售附屬公司、聯營公司及合營企業。
外匯風險
我們的財務報表以人民幣列示，惟若干現金及現金等價物、定期存款、其他應收
款項、按公平值計量且其變動計入損益的金融資產以及貿易及其他應付款項以外
幣計值，並面臨外匯風險。我們目前並無外匯對沖政策。然而，本集團管理層監
察外匯風險，並將考慮於有需要時對沖重大外匯風險。
銀行貸款及其他借款
截至二零二六年六月三十日，本集團的銀行借款為人民幣340,950,000元，所有銀
行借款均以人民幣計值，其中人民幣85,000,000元的借款採用固定利率計息。
或然負債
截至二零二六年六月三十日，本集團概無任何重大或然負債（二零二五年十二月
三十一日：無）。

企業管治及其他資料
本公司為於二零一五年十二月二日在開曼群島註冊成立的有限公司，本公司股份
（「股份」）已於二零一九年二月二十六日在聯交所上市。
遵守企業管治守則
董事會致力於達致高水平的企業管治準則。於報告期內，本公司已遵守香港聯合
交易所有限公司證券上市規則（「上市規則」）附錄C1 所載企業管治守則（「企業管
治守則」）第二部分之所有守則條文。
37

本公司將繼續定期審閱及監察其企業管治常規以確保符合企業管治守則，並保持
本公司高標準的企業管治常規。
上市發行人董事進行證券交易的標準守則
我們採納我們自身有關董事進行證券交易的行為守則，即管理董事證券交易政策
（「證券交易守則」），此守則適用於所有董事，其條款不遜於上市規則附錄C3所載
上市發行人董事進行證券交易的標準守則（「標準守則」）所示的規定標準。
除下文所披露者外，本公司已向全體董事作出具體查詢，而董事已確認彼等於報
告期內已遵守證券交易守則。
於報告期間，二零二六年二月及三月，執行董事楊建新博士（「楊博士」）於發佈
本公司二零二五年年度業績前的禁售期內，在公開市場上合共出售22,127股本公
司股份（「該等出售事項」）。該等出售事項乃根據本公司股份計劃管理人所實施的
「出售以支付稅項(sell-to-cover)」機制自動執行，旨在履行因向楊博士授予的受限
制股份單位歸屬而產生的稅務責任。該等出售事項無意構成楊博士的酌情買賣，
而純粹因該機制的運作而產生，且就該等出售事項而言，楊博士概無任何意圖或
行為涉及利用內幕消息進行買賣。事件發生後，本公司已調整現有歸屬時間表，
以避免歸屬日期落入禁售期或限制買賣期內，並將繼續加強其合規程序及內部監
控，以確保持續遵守標準守則。
有可能獲得我們未刊發內幕消息的本公司員工須遵守標準守則。截至本業績公告
日期，本公司並未注意到員工未遵守標準守則的事件。
購買、出售或贖回上市證券
於報告期間，本公司透過聯交所合共回購4,597,000股股份，詳情載列如下：

月份

已購買
已付總價
股份數目 每股最高價 每股最低價 （不包括開支）
（港元）
（港元）
（港元）

二零二六年六月

4,597,000

4.84

4.37

21,356,924.20

所有4,597,000股購回股份已於二零二六年七月二十七日註銷。期內購買股份乃由
董事根據分別於二零二五年六月二十五日及二零二六年六月二十三日舉行的本公
司股東週年大會上本公司股東批准的購回股份一般授權而進行。該等股份購回充
分彰顯本公司對自身長期業務發展的堅定信心，亦體現本公司高度重視股東價值
回報、持續完善資本回饋機制的理念。
38

除上文所披露者外，於報告期內，本公司及其任何附屬公司概無購買、出售或贖
回本公司的任何上市證券（包括出售任何庫存股份（定義見上市規則））。截至二零
二六年六月三十日，本公司並無持有任何庫存股份（定義見上市規則）。
重大訴訟
於報告期內，本公司並無涉及任何重大訴訟或仲裁。董事亦並不知悉於報告期內
本集團待進行的或對本集團造成威脅的任何重大訴訟或索賠。
報告期後的重大事項
除本業績公告所披露者外及截至本業績公告日期，報告期後概無重大事項。
所得款項淨額用途
二零二零年股份認購事項
於二零二零年九月三十日（交易時段前），本公司與Pfizer Corporation Hong Kong
Limited（「輝瑞」）訂立股份認購協議，據此，輝瑞已有條件同意按認購價每股認
購股份13.37 港元（本公司於二零二零年九月二十九日在聯交所所報收市價為每
股9.30港元）認購合共115,928,803股認購股份（即本公司普通股）
（「二零二零年股
份認購事項」）。二零二零年股份認購事項項下認購股份的總面值為11,592,88 美
元。輝瑞運用科學及其全球資源以改善每個年齡段人們的健康狀況，並於二零二
零年股份認購事項時為獨立於本公司或其關連人士的第三方。配發及發行認購股
份的所得款項總額及淨額為約200.0百萬美元（相當於約人民幣1,355.9百萬元），
即每股認購股份淨認購價13.37 港元，該款項將用於為本公司、輝瑞、基石藥業
（蘇州）有限公司（「基石蘇州」）、拓石藥業（上海）有限公司（「基石上海」）及Pfizer
Investment Co. Ltd.於二零二零年九月三十日訂立的合作協議（「合作協議」）項下的
開發活動提供資金，其中基石蘇州及基石上海均為本公司的全資附屬公司。本公
司訂立二零二零年股份認購事項及合作協議，有助於在本公司向全面的生物製藥
公司轉型時，推進本公司的戰略、商業及財務目標。二零二零年股份認購事項已
於二零二零年十月九日完成。該等所得款項的使用與計劃使用相符，並無重大變
動。

39

下表載列二零二零年股份認購事項所得款項的計劃用途及直至二零二六年六月三
十日的實際使用情況：
截至
截至
二零二五年
二零二六年
十二月三十一日
六月三十日
所得款項
認購事項
未動用
於報告期間
未動用所得
使用百分比
所得款項淨額
所得款項淨額
實際使用
款項淨額
（人民幣百萬元） （人民幣百萬元） （人民幣百萬元） （人民幣百萬元）
為合作協議項下的
開發活動提供資金

100%

1,355.9

338.5

24.9

313.6

附註： 未動用所得款項淨額計劃於二零二七年十二月三十一日前投入使用。誠如本公司二零二
五年年報所披露，董事會注意到，由於與合作協議有關的臨床開發計劃出現變動，二零
二零年股份認購事項所得款項的計劃動用有所延遲。董事會將審慎考慮本公司的未來發
展及市場狀況，以評估及調整預期悉數動用的時間表。

二零二五年四月配售事項
於二零二五年四月二日（交易時段前），本公司與配售代理摩根士丹利亞洲有限公
司訂立一份配售協議，據此，本公司同意通過配售代理按每股配售股份2.933港元
的價格（本公司於二零二五年四月一日在聯交所所報的收市價為每股股份3.45 港
元）向不少於六名承配人配售合共80,000,000 股配售股份（即本公司普通股）
（「二
零二五年四月配售事項」）。淨配售價（經扣除本公司所承擔的相關成本及開支）約
為每股股份2.904港元。二零二五年四月配售事項的配售股份面值總額為8,000美
元。該等承配人為專業、機構或其他投資者，且連同其最終實益擁有人，為獨立
於本公司及其任何關連人士的第三方。二零二五年四月配售事項將擴大本公司的
股東基礎及資本基礎，並加強本集團未來發展的財務狀況。二零二五年四月配售
事項所得款項淨額（經扣除配售佣金及其他相關開支以及專業費用）為約232.29百
萬港元（相當於約人民幣215.82百萬元）。二零二五年四月配售事項已於二零二五
年四月十日完成。該等所得款項的使用與計劃使用相符，並無重大變動或延遲。

40

下表載列二零二五年四月配售事項所得款項的計劃用途及直至二零二六年六月三
十日的實際使用情況：

研發管線「2.0」，尤其是CS5001（一款
處於臨床階段的ROR1 ADC（潛在同類
最佳ROR1 ADC））及CS2009（一款
靶向PD-1、VEGFA及CTLA-4的三特
異性分子，潛在同類首創╱同類最優
的下一代腫瘤免疫骨架）
一般公司用途
總計

截至
截至
二零二五年
二零二六年
配售 十二月三十一日
六月三十日
所得款項
所得款項
未動用
於報告
未動用所得
使用百分比
淨額 所得款項淨額 期間實際使用
款項淨額
（人民幣百萬元） （人民幣百萬元） （人民幣百萬元） （人民幣百萬元）

90%
10%

194.24
21.58

30.34
0.78

30.34
0.78

–
–

100%

215.82

31.12

31.12

–

二零二五年七月配售事項
於二零二五年七月八日（交易時段後），本公司與配售代理摩根士丹利亞洲有限公
司訂立一份配售協議，據此，本公司同意通過配售代理按每股配售股份4.72港元
（本公司於二零二五年七月八日於聯交所之收市價為每股5.18港元）的價格向不少
於六名承配人配售合共100,000,000股配售股份（即本公司普通股）
（「二零二五年七
月配售事項」）。淨配售價（經扣除本公司所承擔的相關成本及開支）約為每股股份
4.673港元。二零二五年七月配售事項的配售股份面值總額為10,000美元。該等承
配人為專業、機構或其他投資者，且連同其最終實益擁有人，為獨立於本公司及
其任何關連人士的第三方。二零二五年七月配售事項將擴大本公司的股東基礎及
資本基礎，並加強本集團未來發展的財務狀況。二零二五年七月配售事項所得款
項淨額（經扣除配售佣金及其他相關開支以及專業費用）為約467.28百萬港元（相
當於約人民幣425.79百萬元）。二零二五年七月配售事項已於二零二五年七月十六
日完成。該等所得款項的使用與計劃使用相符，並無重大變動或延遲。

41

下表載列二零二五年七月配售事項所得款項的計劃用途及直至二零二六年六月三
十日的實際使用情況：
截至
截至
二零二五年
二零二六年
配售 十二月三十一日
六月三十日
所得款項
所得款項
未動用
於報告
未動用所得
使用百分比
淨額 所得款項淨額 期間實際使用
款項淨額
（人民幣百萬元） （人民幣百萬元） （人民幣百萬元） （人民幣百萬元）
與CS2009（II期臨床試驗及潛在關鍵研究）
及CS5001（1b期臨床試驗）相關的
研發，包括單藥及聯合治療研究
與臨床前資產相關的研發，包括候選藥物
的發現和PCC以及新藥臨床試驗申請
研究
一般公司用途（包括員工成本及租賃開支）

73%

310.83

310.83

64.83

246.0

17%
10%

72.38
42.58

72.38
42.58

72.38
21.75

–
20.83

總計

100%

425.79

425.79

158.96

266.83

附註：

未動用所得款項淨額計劃於二零二六年十二月三十一日前投入使用。

二零二六年四月配售事項
於二零二六年四月十四日（交易時段後），本公司與配售代理Goldman Sachs (Asia)
L.L.C.訂立一份配售協議，據此，本公司已有條件同意通過配售代理按每股配售
股份8.97 港元（本公司於二零二六年四月十四日於聯交所之收市價為每股9.64 港
元）的價格向不少於六名承配人配售合共118,000,000 股配售股份（即本公司普通
股）
（「二零二六年四月配售事項」）。淨配售價（經扣除本公司所承擔的相關成本及
開支）約為每股股份8.9252 港元。二零二六年四月配售事項的配售股份面值總額
為11,800美元。該等承配人為專業、機構或其他投資者，且連同其最終實益擁有
人，為獨立於本公司及其任何關連人士的第三方。二零二六年四月配售事項將擴
大本公司的股東基礎及資本基礎，並加強本集團未來發展的財務狀況。二零二六
年四月配售事項所得款項淨額（經扣除配售佣金及其他相關開支以及專業費用）為
約1,053.17百萬港元（相當於約人民幣923.0百萬元）。二零二六年四月配售事項已
於二零二六年四月二十二日完成。該等所得款項的使用與計劃使用相符，並無重
大變動或延遲。

42

下表載列二零二六年四月配售事項所得款項的計劃用途及直至二零二六年六月三
十日的實際使用情況：
截至
二零二六年
配售
六月三十日
所得款項
所得款項
於報告
未動用所得
使用百分比
淨額
期間實際使用
款項淨額
（人民幣百萬元） （人民幣百萬元） （人民幣百萬元）
與CS2009相關的研發，包括II期臨床試驗（設有
15個隊列探索單藥治療及聯合療法研究），
以及潛在首批III期多區域臨床試驗(MRCT)
與CS5001及臨床前資產（如CS5007
(EGFR/HER3 ADC)）以及針對免疫
及炎症疾病的其他專有ADC與多特異性
抗體相關的研發，包括候選藥物的發現
和PCC，以及新藥臨床試驗申請研究
一般公司用途（包括員工成本及租賃開支）
總計

60%

553.8

–

553.8

30%
10%

276.9
92.3

–
–

276.9
92.3

100%

923.0

–

923.0

附註：未動用所得款項淨額計劃於二零二七年十二月三十一日前投入使用。

審核委員會
本 公 司 已 根 據 上 市 規 則 成 立 一 個 具 有 書 面 職 權 範 圍 的 審 核 委 員 會（「審 核 委 員
會 」）。 審 核 委 員 會 現 時 由 三 位 獨 立 非 執 行 董 事 組 成 ， 即 謝 芳 女 士（ 主 席 ）、
Kenneth Howard Jarrett先生及嚴嘉洵女士。
審核委員會已考慮及檢討本集團所採納的會計原則及慣例，並與管理層討論有關
內部控制及財務報告的事宜。審核委員會已檢討及認為截至二零二六年六月三十
日止六個月的中期財務業績符合相關會計準則、規則及法規，並已妥為作出適當
披露。

43

中期業績審閱
本公司獨立核數師德勤•關黃陳方會計師行已根據國際審計與鑒證準則理事會頒佈
的國際審閱委聘準則第2410號由實體的獨立核數師進行的中期財務資料審閱 審閱
中期財務資料。審核委員會已經與本公司管理層共同審閱本集團採納的會計原則
及慣例，並已就本集團的內部控制及財務報告事宜（包括審閱截至二零二六年六
月三十日止六個月的未經審核中期業績）進行討論。

中期股息
董事會不建議派付截至二零二六年六月三十日止六個月的中期股息（二零二五年：
無）。

刊發中期業績公告及中期報告
本公告將刊登於聯交所網站(www.hkexnews.hk )及本公司網站(www.cstonepharma.com)。
截至二零二六年六月三十日止六個月的中期報告（載有上市規則附錄D2規定之所
有資料）將適時於聯交所及本公司網站刊載。

致謝
董事會衷心感謝本集團的股東、管理團隊、僱員、業務夥伴及客戶為本集團提供
的支持及作出的貢獻。
承董事會命
基石藥業
李偉博士
主席
中華人民共和國，蘇州，二零二六年八月二十七日

於本公告刊發日期，董事會包括主席兼非執行董事李偉博士、執行董事楊建新博
士、非執行董事Kenneth Walton Hitchner III先生及胡正國先生以及獨立非執行董
事Kenneth Howard Jarrett先生、謝芳女士及嚴嘉洵女士。

44