🇭🇰 港交所ASCLETIS-BQwen · 实盘不做把握 2/10不做原因:无增量信息🔁 +4 同一事件
北京时间·🕒 发布 21:14:00时区推断·⟳ 抓取 21:16:28·⚡ 决策 08-31 21:24:27 +7m59s·57.3 天前
歌礼制药(1672.HK)发布2026年中期业绩:亏损扩大263.5%至3.2亿元,系研发管线投入增加所致,无新催化
歌礼制药为pre-revenue 18A生物科技公司,市场定价完全由管线里程碑和数据读出驱动。本次中期业绩所有信息(ASC30 III期启动、现金充裕、研发支出增加、免疫管线寻求授权)均为已知预期的例行披露,无任何新增数据、交易或监管事件构成短线催化。亏损扩大是计划内的研发投入增加,不是负面surprise。
📄 原文ASCLETIS-B↗ 原文
Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility for the con…
不做 歌礼制药(01672.HK)
Pre-revenue 18A生物科技公司的例行中期业绩披露:亏损扩大系计划内研发投入增加(非负面surprise),所有管线里程碑均为已知预期的前瞻性陈述,无新数据读出、无新授权交易、无监管批准、无现金缺口。对这类公司,股价催化来自管线数据读出和交易达成,而非季度/半年度财务报表。无短线交易edge。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
结论摘要
歌礼制药(1672.HK)是pre-revenue 18A生物科技公司,2026H1亏损3.197亿元(同比+263.5%),完全由研发支出增加(+132.7%至3.417亿元)驱动,用于ASC30全球III期等代谢管线推进。现金储备23.05亿元充足至2029年。所有管线里程碑(ASC30 III期首例给药、ASC30糖尿病II期数据Q3 2026、多个IND递交)均为已知预期的前瞻性陈述,无新增已实现数据或交易。对pre-revenue biotech,例行中期财务数据不构成股价催化。
🔎 新鲜度:最早出现 2026-08-31 · 扩散 low · price-in 风险 low ↗
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原文全文
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Hong Kong Exchanges and Clearing Limited and The Stock Exchange of Hong Kong Limited take no responsibility
for the contents of this announcement, make no representation as to its accuracy or completeness and expressly
disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the
contents of this announcement.
This announcement contains forward-looking statements that involve risks and uncertainties. All statements other
than statements of historical fact are forward-looking statements. These statements involve known and unknown risks,
uncertainties and other factors, some of which are beyond the Company ’s control, that may cause the actual results,
performance or achievements to be materially different from those expressed or implied by the forward-looking
statements. You should not rely upon forward-looking statements as predictions of future events. The Company
undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information,
future events or otherwise.
Ascletis Pharma Inc.
歌禮製藥有限公司
(Incorporated in the Cayman Islands with limited liability)
STOCK CODE: 1672
INTERIM RESULTS ANNOUNCEMENT
FOR THE SIX MONTHS ENDED JUNE 30, 2026
The Board hereby announces the unaudited consolidated interim results of the Group for the six
months ended June 30, 2026, together with the comparative figures for the corresponding period in
2025 as follows.
FINANCIAL HIGHLIGHTS
Unaudited
Six months ended June 30,
2026
2025
Changes
(RMB ’000)
(RMB ’000)
%
Total income(1)
Research and development costs
Administrative expenses
Other expenses
Finance costs
Loss before taxation
Income tax
Loss for the period
Attributable to:
Equity shareholders of the Company
Loss per share
Basic and diluted
52,979
(341,663)
(30,803)
(12)
(74)
(319,573)
(98)
(319,671)
103,577
(146,812)
(43,302)
(367)
(87)
(87,951)
–
(87,951)
(48.9)
132.7
(28.9)
(96.7)
(14.9)
263.4
–
263.5
(319,671)
(87,951)
263.5
RMB
RMB
(30.74) cents
(9.14) cents
Note:
(1)
The Group’s total income represents revenue, other income and gains.
1
CORPORATE PROFILE
Our Vision
Ascletis’ vision is to become the most innovative world-class biomedical company addressing
global unmet medical needs in the area of metabolic diseases.
Overview
During the Reporting Period and up to the date of this announcement, the Group made significant
progress for its metabolic disease pipeline:
(i)
The global Phase III clinical program for ASC30 chronic weight management indication has
been initiated, consisting of two pivotal global Phase III, multicenter, randomized, doubleblind, placebo-controlled trials (AURORA-1 and AURORA-2) in a total of approximately
4,600 participants with obesity or overweight in the U.S., Europe, and Canada. Recently, the
first participant has been dosed in the global Phase III clinical program of ASC30 for chronic
weight management. The Group expects to announce topline data from the ASC30 Phase III
clinical program in the third quarter of 2028, with an FDA NDA filing expected by the end of
2028 and an EMA MAA filing expected in early 2029. The Group has sufficient cash on hand
to support its operations into 2029, beyond the expected submission of an NDA and an MAA
for ASC30.
(ii)
ASC30 oral small molecule GLP-1 once-daily tablet for diabetes is being evaluated in a U.S.
13-week Phase II study. Topline data are expected in the third quarter of 2026.
(iii) ASC39, a potentially first-in-class once-daily oral small molecule eloralintide-like selective
amylin receptor agonist (SARA), demonstrated eloralintide-like amylin selectivity and
efficacy in preclinical models, and submission of an IND application to the FDA for ASC39
oral tablets is expected in the third quarter of 2026.
(iv) ASC30_39FDC, a fixed-dose combination of ASC30 and ASC39 has been selected as
a clinical development candidate, and submission of an IND application to the FDA for
ASC30_39FDC oral tablets is expected in the third quarter of 2026.
(v)
ASC30_48FDC, a fixed-dose combination of ASC30 and ASC48, a potentially first-in-class
oral small molecule GIPR agonist, has been selected as a clinical development candidate, and
submission of an IND application to the FDA for ASC30_48FDC oral tablets is expected in
the fourth quarter of 2026.
(vi) ASC30_48_39FDC, a fixed-dose combination of ASC30, ASC48, and ASC39 has been selected for
clinical development, and submission of an IND application to the FDA for ASC30_48_39FDC
oral tablets is expected in the fourth quarter of 2026.
(vii) ASC36, a once-monthly to once-quarterly, potentially best-in-class subcutaneously administered
amylin receptor agonist for obesity, has obtained the IND clearance by the FDA and topline
pharmacokinetic data are expected to be announced by the end of 2026.
(viii) ASC36 oral tablets, the Company’s first oral amylin receptor peptide agonist, has submitted
an IND application to the FDA and Phase I trials are expected to be initiated in the third
quarter of 2026.
2
(ix) ASC35, a once-monthly potentially best-in-class subcutaneously administered GLP-1R/GIPR
dual peptide agonist for obesity has obtained the IND clearance by the FDA and topline
pharmacokinetic data are expected to be announced by the end of 2026.
(x)
ASC36_35FDC, a fixed-dose combination of ASC36 and ASC35, has obtained the IND clearance
by the FDA and topline pharmacokinetic data are expected to be announced at the beginning
of the first quarter of 2027.
(xi) ASC37 injection, a next-generation, once-monthly, subcutaneously administered GLP-1R/
GIPR/GCGR triple peptide agonist, has been selected as a clinical development candidate and
submission of an IND application to the FDA for ASC37 injection is expected in the third
quarter of 2026.
(xii) ASC37 oral tablet has been selected as a clinical development candidate and submission of
an IND application to the FDA for ASC37 oral tablet is expected in the third quarter of 2026.
(xiii) ASC36_37FDC, a fixed-dose combination of ASC36 and ASC37, has been selected for
clinical development, and submission of an IND application to the FDA for ASC36_37FDC
injection is expected in the third quarter of 2026.
During the Reporting Period and up to the date of this announcement, the Group made significant
progress for its immune disease pipeline:
(i)
ASC50, an IL-17A oral small molecule inhibitor, has completed the U.S. Phase I SAD study
in healthy subjects and the U.S. Phase I proof of concept (POC) 28-day study (200 mg QD) in
mild-to-moderate plaque psoriasis patients. Human data suggest that ASC50 is a potentially
first-in-class and best-in-class oral small molecule IL-17A inhibitor.
(ii)
ASC51, a potent, selective, and once-daily oral STAT6 degrader, is an FDA-IND ready
candidate. ASC51 has completed all IND-enabling studies required by the FDA and is
potentially the second-in-class STAT6 oral small molecule degrader after KT-62.
(iii) ASC52 has the potential to be the best-in-class IL-17AA, AF and FF oral cyclic peptide
antagonist and its IND filing to the FDA is expected in the fourth quarter of 2026. ASC52 is
the potentially second-in-class IL-17AA, AF and FF oral cyclic peptide antagonist after PN881.
These achievements underscored the Group ’ s strong R&D capabilities, best execution and
longstanding commitments to discovering and developing global best-in-class/first-in-class pipeline
to address unmet clinical needs.
As at June 30, 2026, the Group had cash and cash equivalents, time deposits, transferable certificates
of deposit, structured deposits and wealth management products of approximately RMB2,305.4
million (June 30, 2025: approximately RMB1,827.9 million) to support its operations into 2029.
3
The R&D costs of the Group increased by 132.7% from approximately RMB146.8 million for
the six months ended June 30, 2025 to approximately RMB341.7 million for the six months
ended June 30, 2026. The significant increase in R&D expenses is primarily due to the Group ’s
strategic commitment to advance its comprehensive metabolic disease pipeline, including both
small molecules and peptides. The loss for the period of the Group increased by 263.5% from
approximately RMB88.0 million for the six months ended June 30, 2025 to approximately
RMB319.7 million for the six months ended June 30, 2026, primarily due to the increase in R&D
costs described above.
During the Reporting Period and up to the date of this announcement, the Group’s pipelines and
their progress are summarized below:
4
Metabolic Disease Pipeline - Small Molecules
Product
(Modality)
Target
Indication
Commercial
Rights
ASC30
(Once-daily oral small
molecule agonist)
GLP-1R
Obesity
Global
ASC30
(Once-daily oral small
molecule agonist)
GLP-1R
Diabetes
Global
ASC39
(Once-daily oral small
molecule agonist)
Amylin Receptor SARA
Obesity
Global
ASC30_39FDC
(Once-daily oral small
molecule dual agonist)
GLP-1R/
Amylin Receptor SARA
Obesity
Global
ASC30_48FDC
(Once-daily oral small
molecule dual agonist)
GLP-1R/GIPR
Obesity
Global
ASC30_48_39FDC
(Once-daily oral small
molecule triple agonist)
GLP-1R/GIPR/
Amylin Receptor SARA
Obesity
Global
Discovery
IND Enabling
Phase I
Phase II
Phase Ⅲ
Discovery
IND Enabling
Phase I
Phase II
Phase Ⅲ
Discovery
IND Enabling
Phase I
Phase II
Phase Ⅲ
Metabolic Disease Pipeline - Peptides
Product
(Modality)
Target
Indication
Commercial
Rights
ASC36i
(Once-monthly to oncequarterly subcutaneous
peptide agonist)
Amylin Receptor
Obesity
Global
ASC36o
(Oral peptide agonist)
Amylin Receptor
Obesity
Global
ASC35
(Once-monthly subcutaneous
peptide agonist)
GLP-1R/GIPR
Obesity
Global
ASC36_35FDC
(Once-monthly subcutaneous
triple peptide agonist)
Amylin Receptor+
GLP-1R/GIPR
Obesity
Global
ASC37i
(Once-monthly subcutaneous
triple peptide agonist)
GLP-1R/GIPR/GCGR
Obesity
Global
ASC37o
(Oral peptide agonist)
GLP-1R/GIPR/GCGR
Obesity
Global
ASC36_37FDC
(Once-monthly subcutaneous
quadruple peptide agonist)
Amylin Receptor+
GLP-1R/GIPR/GCGR
Obesity
Global
Immune Disease Pipeline
Product
(Modality)
Target
Indication
Commercial
Rights
ASC50
(Once-daily oral small
molecule inhibitor)
IL-17A
Psoriasis and other
immune diseases
Global
ASC51
(Once-daily oral small
molecule degrader)
STAT6
Immune diseases
Global
ASC52
(Once-daily oral cyclic peptide
inhibitor)
IL-17A and F
Immune diseases
Global
Exploratory Indication Pipeline
Product
(Modality)
Target
Indication
Commercial
Rights
ASC40
(Oral small molecule)
FASN
ACNE
Greater China1
Discovery
IND Enabling
Phase I
Phase II
Phase Ⅲ
NDA
Note:
1. Denifanstat (ASC40) is licensed from Sagimet for the exclusive rights in Greater China.
Abbreviations:
GLP-1R: glucagon-like peptide 1 receptor; SARA: selective amylin receptor agonist; FDC: fixed-dose
combination; GIPR: gastric inhibitory polypeptide receptor; GCGR: glucagon receptor; STAT6: Signal
Transducer and Activator of Transcription 6; IL-17A and F: interleukin-17A and F; FASN: Fatty acid
synthase.
5
MANAGEMENT DISCUSSION AND ANALYSIS
BUSINESS REVIEW
During the Reporting Period and up to the date of this announcement, the Group has made the
following progress with respect to its business.
Metabolic Diseases
Small Molecules
ASC30 oral once-daily tablet for obesity
During the Reporting Period and up to the date of this announcement, the Group has received
Phase III clearance from the FDA and initiated a global Phase III clinical program for ASC30
chronic weight management indication consisting of two pivotal global Phase III, multicenter,
randomized, double-blind, placebo-controlled trials (AURORA-1, NCT07743463 and AURORA-2,
NCT07743450) in a total of approximately 4,600 participants with obesity or overweight in the
U.S., Europe, and Canada. Recently, the first participant has been dosed in the global Phase III
clinical program of ASC30 for chronic weight management.
The two pivotal studies will investigate the long-term efficacy, safety, and tolerability of three
maintenance doses (20 mg, 40 mg and 60 mg) of once-daily oral ASC30 compared with placebo in
participants with obesity or overweight without type 2 diabetes (AURORA-1) and in participants
with obesity or overweight with type 2 diabetes (AURORA-2). The treatment duration of both
AURORA-1 and AURORA-2 are 72 weeks.
The Company expects to announce topline data from the ASC30 Phase III clinical program in the
third quarter of 2028, with an FDA NDA filing expected by the end of 2028 and an EMA MAA
filing expected in early 2029. If approved by the respective regulatory authorities in the U.S. and
Europe, this will make ASC30 potentially the second oral small molecule GLP-1 approved in the
U.S. and Europe after orforglipron.
Anticipated 2026 Milestone: The Group has achieved the 2026 milestone as the first participant
has been dosed in the global Phase III clinical program of ASC30 for chronic weight management.
ASC30 oral once-daily tablet for diabetes
During the Reporting Period and up to the date of this announcement, the Group has completed
enrollment in its 13-week U.S. Phase II study (NCT07321678) evaluating ASC30, an oral small
molecule GLP-1R agonist, for the treatment of type 2 diabetes mellitus (T2D). T2D is the second
indication for ASC30, following its first indication of obesity.
Anticipated 2026 Milestone: Expected to announce the topline data from the U.S. 13-week Phase
II study of ASC30 oral once-daily tablet for the treatment of diabetes in the third quarter of 2026.
6
ASC39 once-daily oral tablet for obesity
During the Reporting Period and up to the date of this announcement, the Group has selected
ASC39, a potentially first-in-class once-daily oral small molecule eloralintide-like selective amylin
receptor agonist (SARA), as a clinical development candidate.
In a head-to-head cAMP activation assay vs. eloralintide, oral small molecule amylin receptor
agonist ASC39 demonstrated similar selectivity and potency to that of eloralintide. EC50 for
hAMY1R was 21.4 pM and 21.2 pM for ASC39 and eloralintide, respectively. EC50 for hCTR was
846.1 pM and 1,350.8 pM for ASC39 and eloralintide, respectively. These data indicate ASC39
and eloralintide have similar selectivity for hAMY1R over hCTR.
In a head-to-head DIO rat study vs. eloralintide, efficacy of ASC39 oral dosing was comparable to
that of eloralintide, demonstrating significant placebo adjusted weight loss of 6.6% and 5.6% for
ASC39 and eloralintide, respectively.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC39 oral
tablets for the treatment of obesity in the third quarter of 2026.
ASC30_39FDC once-daily oral tablet for obesity
During the Reporting Period and up to the date of this announcement, the Group has selected
ASC30_39FDC, a fixed-dose combination of ASC30, once-daily oral small molecule GLP-1R
agonist and ASC39, a potentially first-in-class once-daily oral small molecule eloralintide-like
SARA, for clinical development.
ASC30_39FDC tablets, dosed orally in dogs, demonstrated comparable pharmacokinetics to those
observed in their respective monotherapies in a head-to-head study. The fixed-dose combination
had excellent oral bioavailability, drug exposure and a half-life of up to 12 hours. These data
support ASC30_39FDC tablets as a potential novel one-pill, once-daily therapy for obesity.
ASC30_39FDC demonstrated excellent compatibility between ASC30 and ASC39 when combined
together, with room temperature stability and a small pill size.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC30_39FDC
oral tablets for the treatment of obesity in the third quarter of 2026.
ASC30_48FDC once-daily oral tablet for obesity
During the Reporting Period and up to the date of this announcement, the Group has selected a
fixed-dose combination of ASC48, a potentially first-in-class oral small molecule GIPR agonist,
and ASC30, an oral small molecule GLP-1R agonist, for clinical development. ASC30_48FDC is a
potentially first-in-class oral one-pill, once-daily therapy for obesity, targeting GLP-1R and GIPR.
ASC48 demonstrated an EC50 of 1 pM in the hGIPR cAMP activation assay, exhibiting greater
potency than tirzepatide (EC50 = 3 pM) and is a selective agonist for GIPR without activity for
GLP-1R and GCGR.
7
ASC48 demonstrated excellent oral bioavailability and drug exposure as well as long half-life in
rodents and NHPs, supporting once-daily oral dosing in humans.
ASC30_48FDC demonstrated approximately 52% greater relative body weight reduction compared
to ASC30 monotherapy in a head-to-head NHP study.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC30_48FDC
oral tablets for the treatment of obesity in the fourth quarter of 2026.
ASC30_48_39FDC once-daily oral tablet for obesity
During the Reporting Period and up to the date of this announcement, the Group has announced
positive data for its potentially first-in-class once-daily oral small molecule GLP-1/GIP/amylin
triple agonist fixed-dose combination. It demonstrated a GIPR agonist (ASC48) dose-dependent,
statistically significant body weight reduction of up to 15.2% in NHPs after seven-day treatment.
This represents an up to 120% greater relative body weight reduction compared to oral dual agonist
fixed-dose combination targeting GLP-1R and amylin receptor (SARA) (ASC30_39FDC). The data
suggest that GIP component (ASC48) is critical to ASC30_48_39FDC triple agonist.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC30_48_39FDC
oral tablets for the treatment of obesity in the fourth quarter of 2026.
Peptides
ASC36 once-monthly to once-quarterly SQ peptide for obesity
During the Reporting Period and up to the date of this announcement, the Group has obtained the
IND clearance by the FDA and initiated the Phase I study of ASC36, a once-monthly to oncequarterly next-generation amylin receptor peptide agonist.
ASC36 once-monthly to once-quarterly formulation is SALD formulation, developed in-house
utilizing Ascletis’ Ultra-Long-Acting Platform (ULAP) technology.
In head-to-head NHP studies, ASC36 SALD formulation demonstrated approximately 6-fold longer
observed half-life than eloralintide, supporting once-monthly to once-quarterly SQ administration
in humans.
ASC36 monotherapy demonstrated approximately 91% and 32% greater relative body weight
reduction compared to petrelintide and eloralintide monotherapies, respectively, in head-to-head DIO
rat studies.
Anticipated 2026 Milestone: Expected to announce topline pharmacokinetic data of ASC36 oncemonthly to once-quarterly SQ peptide by the end of 2026.
ASC36 oral peptide for obesity
During the Reporting Period and up to the date of this announcement, the Group has submitted an
IND application to the FDA for ASC36 oral tablets.
8
Utilizing Ascletis’ Peptide Oral Transport ENhancement Technology (POTENT), ASC36 oral tablets
achieved absolute oral bioavailability of 6% to 8% at steady state, in NHP studies.
In NHPs, ASC36 oral tablets reduced mean body weight up to 13.2% from baseline after oncedaily dosing for 7 days. ASC36 tablets also reduced food intake significantly.
ASC36 oral tablets are expected to utilize a lower dose due to potentially better oral bioavailability
and efficacy. This superior weight loss per milligram of ASC36 peptide may also provide
scalability advantages in manufacturing.
Anticipated 2026 Milestone: Expected to initiate Phase I trials of ASC36 oral peptide for the treatment
of obesity in the third quarter of 2026.
ASC35 once-monthly SQ peptide for obesity
During the Reporting Period and up to the date of this announcement, the Group has obtained the
IND clearance by the FDA and initiated the Phase I study of ASC35, a potentially best-in-class,
once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist, for the treatment
of obesity.
ASC35 once-monthly formulation is SALD formulation, developed in-house utilizing Ascletis’
Ultra-Long-Acting Platform (ULAP) technology. In head-to-head NHP studies, the average
observed half-life of ASC35 was approximately six-fold longer than tirzepatide, which supports
once-monthly SQ dosing in humans.
In a head-to-head DIO mouse study, ASC35 demonstrated approximately 71% greater relative body
weight reduction compared to tirzepatide.
Anticipated 2026 Milestone: Expected to announce topline pharmacokinetic data of ASC35 oncemonthly SQ peptide by the end of 2026.
ASC36_35FDC once-monthly SQ peptides for obesity
During the Reporting Period and up to the date of this announcement, the Group has obtained the
IND clearance by the FDA and initiated the Phase I study of ASC36_35FDC, a once-monthly SQ
fixed-dose combination injection of ASC36 and ASC35.
ASC36_35FDC once-monthly formulation is SALD formulation, developed in-house utilizing
Ascletis’ Ultra-Long-Acting Platform (ULAP) technology.
In NHP studies, ASC36_35FDC SALD co-formulation demonstrated long observed half-lives for
both ASC36 and ASC35, supporting once-monthly SQ administration in humans.
In head-to-head DIO rat studies, ASC36_35FDC, targeting three targets of amylin receptor, GLP1R and GIPR, demonstrated approximately 51% greater relative body weight reduction compared
to the co-administration of eloralintide and tirzepatide.
Anticipated 2027 Milestone: Expected to announce topline pharmacokinetic data of ASC36_35FDC
once-monthly SQ peptides at the beginning of the first quarter of 2027.
9
ASC37 once-monthly SQ peptide for obesity
During the Reporting Period and up to the date of this announcement, the Group has selected
ASC37 injection, a next-generation, once-monthly, subcutaneously administered GLP-1R/GIPR/
GCGR triple peptide agonist, as a clinical development candidate.
ASC37 was engineered to have 41 alpha amino acids, which qualifies it as a biologic. Biologics
license applications (BLAs) for ASC37 once-monthly SQ formulation will be submitted to the
FDA after completion of Phase III study.
ASC37 SQ SALD formulation had an average observed half-life of approximately 17 days compared
to 2.5 days for retatrutide. This approximately 7-fold longer half-life for ASC37 confirms oncemonthly or less dosing frequency.
ASC37 demonstrated statistically significant 88% greater relative body weight reduction compared
to tirzepatide in the DIO mouse model.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC37 injection
for the treatment of obesity in the third quarter of 2026.
ASC37 oral peptide for obesity
During the Reporting Period and up to the date of this announcement, the Group has continued the
development of ASC37 oral tablet.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC37 oral
tablet for the treatment of obesity in the third quarter of 2026.
ASC36_37FDC once-monthly SQ peptides for obesity
During the Reporting Period and up to the date of this announcement, the Group has selected
ASC36_37FDC, a once-monthly SQ GLP-1/GIP/GCG/amylin quadruple agonist fixed-dose
combination injection of ASC36 and ASC37.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC36_37FDC
injection for the treatment of obesity in the third quarter of 2026.
Although significant progress for its immune disease pipeline was made during the Reporting
Period and up to the date of this announcement, the Group has made a strategic decision to focus
on its metabolic disease pipeline and is seeking out-licensing opportunities for ASC50, ASC51 and
ASC52. This strategy will allow the Group to focus all of its resources on its metabolic disease
pipeline and have sufficient cash on hand to support its operations into 2029.
During the Reporting Period and up to the date of this announcement, the Group had positive
interactions with NMPA on denifanstat (ASC40) NDA for its moderate to severe acne indication.
The Group continues to work with NMPA with the goal to make denifanstat (ASC40) available to
patients. Denifanstat (ASC40)is licensed from Sagimet for the exclusive rights in Greater China.
10
Preclinical Discovery
Based on its three core discovery engines: (i) Artificial Intelligence-assisted Structure-Based Drug
Discovery (AISBDD); (ii) Ultra-Long-Acting Platform (ULAP); and (iii) Peptide Oral Transport
ENhancement Technology (POTENT), the Group continues to strengthen discovery efforts to
develop more pipeline assets of both small molecules and peptides with global best-in-class and
first-in-class competitiveness.
Cautionary statement required by Rules 18A.05 and 18A.08(3) of the Listing Rules: We
cannot guarantee that we will be able to ultimately develop, market and/or commercialize the drug
candidates in our pipeline successfully.
THE GROUP’S FACILITIES
The Group has manufacturing facilities located in Shaoxing, Zhejiang Province with a total gross
floor area of approximately 17,000 square meters. Our manufacturing facility is equipped with
state-of-the-art production equipment with cutting-edge technology capabilities such as hot-melt
extrusion and high-speed presses to ensure the high quality of our products.
As at June 30, 2026, the Group had 10 wholly-owned subsidiaries. The majority of the Group’s
business was conducted through Ascletis Pharma (China) in Hong Kong, while the minority of the
Group’s business was conducted through Ascletis BioScience and Ascletis Pharmaceuticals in
Chinese Mainland.
FUTURE AND OUTLOOK
The Group has established a comprehensive metabolic disease pipeline with key clinical stage
assets. The following are strategies and outlook for the second half of 2026:
1.
Expected to announce the topline data from the U.S. 13-week Phase II study of ASC30 oncedaily tablet for the treatment of diabetes in the third quarter of 2026;
2.
Expected to submit an IND application to the FDA for ASC39 oral tablets for the treatment
of obesity in the third quarter of 2026;
3.
Expected to submit an IND application to the FDA for ASC30_39FDC oral tablets for the
treatment of obesity in the third quarter of 2026;
4.
Expected to submit an IND application to the FDA for ASC30_48FDC oral tablets for the
treatment of obesity in the fourth quarter of 2026;
5.
Expected to submit an IND application to the FDA for ASC30_48_39FDC oral tablets for the
treatment of obesity in the fourth quarter of 2026;
6.
Expected to announce topline pharmacokinetic data of ASC36 once-monthly to once-quarterly
SQ peptide by the end of 2026;
11
7.
Expected to initiate Phase I trials of ASC36 oral peptide for the treatment of obesity in the
third quarter of 2026;
8.
Expected to announce topline pharmacokinetic data of ASC35 once-monthly SQ peptide by
the end of 2026;
9.
Expected to submit an IND application to the FDA for ASC37 injection for the treatment of
obesity in the third quarter of 2026;
10.
Expected to submit an IND application to the FDA for ASC37 oral tablet for the treatment of
obesity in the third quarter of 2026;
11.
Expected to submit an IND application to the FDA for ASC36_37FDC injection for the
treatment of obesity in the third quarter of 2026;
12.
Continue to strengthen early discovery efforts to develop more pipeline assets with global
best-in-class and first-in-class competitiveness;
13.
Seek license-out opportunities with global large pharma companies to maximize the value of
the Group; and
14.
The Group has sufficient cash on hand to support its operations into 2029, beyond the
expected submission of an NDA to the FDA and an MAA to EMA.
FINANCIAL REVIEW
Total income
The Group’s total income represents revenue, other income and gains. It decreased from approximately
RMB103.6 million for the six months ended June 30, 2025 to approximately RMB53.0 million for
the six months ended June 30, 2026, primarily due to a decline in one-off non-recurring income,
mainly from government grants for Chinese Mainland entities.
Other Income and Gains
The other income and gains of the Group decreased by 48.3% from approximately RMB102.5 million for
the six months ended June 30, 2025 to approximately RMB53.0 million for the six months ended
June 30, 2026, primarily because (i) a decrease in government grants for Chinese Mainland entities
from approximately RMB34.2 million for the six months ended June 30, 2025 to approximately
RMB1.2 million for the six months ended June 30, 2026; (ii) a decrease in net realized and
unrealized gains from equity investment from approximately RMB37.7 million for the six months
ended June 30, 2025 to approximately RMB17.3 million for the six months ended June 30, 2026.
The decrease was primarily attributable to a lower fair value gain on the Group’s investment in
Sagimet, which is measured at FVPL, as a result of the lower appreciation in Sagimet’s share price
during the Reporting Period compared with the corresponding period in 2025; and (iii) a significant
increase in foreign exchange loss from approximately RMB1.3 million for the six months ended
June 30, 2025 to approximately RMB10.1 million for the six months ended June 30, 2026, which
was offset by a significant increase in bank interest income from approximately RMB30.0 million
for the six months ended June 30, 2025 to RMB39.5 million for the six months ended June 30,
2026.
12
The following table sets forth the components of our other income and gains for the periods
indicated:
Unaudited
Six months ended June 30,
2026
2025
RMB ’000
RMB ’000
Bank interest income
Net realized and unrealized gains arising from
equity investment
Net realized and unrealized gains arising from wealth
management products and structured deposits
Net realized and unrealized gains on financial assets at FVOCI
Government grants
Foreign exchange loss, net
Others
Total
39,466
30,037
17,336
37,679
3,643
709
1,188
(10,110)
747
1,472
431
34,175
(1,308)
10
52,979
102,496
Administrative Expenses
The administrative expenses of the Group decreased by 28.9% from approximately RMB43.3
million for the six months ended June 30, 2025 to approximately RMB30.8 million for the six
months ended June 30, 2026, primarily due to the decrease in staff related costs.
Our administrative expenses primarily consisted of (i) staff salary and welfare costs for non-R&D
personnel; (ii) agency and consulting fees; and (iii) utilities, rent and general office expenses.
The following table sets forth the components of our administrative expenses for the periods indicated:
Unaudited
Six months ended June 30,
2026
2025
RMB ’000
%
RMB ’000
%
Staff salary and welfare
Agency and consulting fees
Utilities, rent and general office expenses
Others
12,612
13,959
4,092
140
40.9
45.3
13.3
0.5
20,517
17,548
4,897
340
47.4
40.5
11.3
0.8
Total
30,803
100.0
43,302
100.0
13
R&D Expenses
The Group’s R&D expenses primarily consisted of preclinical and clinical trial expenses, staff
costs and depreciation and amortization costs.
The R&D expenses of the Group increased by 132.7% from approximately RMB146.8 million for
the six months ended June 30, 2025 to approximately RMB341.7 million for the six months ended
June 30, 2026, primarily due to the Group’s increased investment in metabolic disease pipeline.
The Group ’ s increased investment in metabolic disease pipeline aligns with the significant
advancements made in this area.
Despite significant increase in R&D expenses, as at June 30, 2026, the Group had cash and cash
equivalents, time deposits, transferable certificates of deposit, structured deposits and wealth
management products of approximately RMB2,305.4 million (June 30, 2025: approximately
RMB1,827.9 million) to support its operations into 2029.
The following table sets forth the components of our R&D costs for the periods indicated:
Unaudited
Six months ended June 30,
2026
2025
RMB ’000
RMB ’000
Preclinical and clinical trial expenses
Staff costs
Depreciation and amortization costs
Others
268,394
55,812
7,657
9,800
75,897
60,796
5,553
4,566
Total
341,663
146,812
The following table sets forth the components of our R&D costs by product pipeline for the periods
indicated:
Unaudited
Six months ended June 30,
2026
2025
RMB ’000
RMB ’000
Metabolic diseases
Exploratory indications
Pre-clinical
145,777
14,506
181,380
42,640
66,149
38,023
Total
341,663
146,812
14
Finance Costs
The Group recorded approximately RMB0.1 million of finance costs for the six months ended June
30, 2026 due to the interest on the lease liabilities (June 30, 2025: approximately RMB0.1 million).
Income Tax
The Group is subject to income tax on an entity basis on profits arising in or derived from the
jurisdictions in which members of the Group are domiciled and operated.
The Group calculated the income tax expense by using the tax rate that would be applicable to the
expected total annual earnings.
The Group recorded income tax of approximately RMB0.1 million for the six months ended June
30, 2026 (June 30, 2025: Nil).
Inventories
The inventories of the Group consisted of raw materials used in research and development. Our
inventories decreased by 37.6% from approximately RMB1.9 million as at December 31, 2025
to approximately RMB1.2 million as at June 30, 2026, mainly due to the strengthening of the
management of inventory.
The following table sets forth the inventory balances as of the dates indicated:
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Raw materials
1,169
1,874
Total
1,169
1,874
Trade Receivables
The Group’s trade receivables decreased from approximately RMB0.2 million as at December 31,
2025 to nil as at June 30, 2026.
The following table sets forth the trade receivables balances as of the dates indicated:
15
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Trade receivables
–
223
Total
–
223
The Group’s trading terms with its customers are mainly on credit. The credit period is generally
from 30 days to 90 days. The Group seeks to maintain strict control over its outstanding
receivables and overdue balances are regularly reviewed by senior management. Trade receivables
are non-interest-bearing.
An aging analysis of the trade receivables as at the dates indicated, based on the invoice date and
net of loss allowance, is as follows:
Within 3 months
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
–
223
–
223
Prepayments, Other Receivables and Other Assets
The following table sets forth the components of prepayment, other receivables and other assets as
at the dates indicated:
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Value-added tax recoverable
Deposits and other receivables
Prepayments
Prepaid expenses
17,362
4,122
3,478
1,250
9,940
3,056
3,544
1,207
Total
26,212
17,747
16
Our value-added tax recoverable represented value-added tax (“VAT”) that can be carried forward
for future offset against output VAT or refunded by the relevant tax authorities. Our value-added
tax recoverable increased by 74.7% from approximately RMB9.9 million as at December 31, 2025
to approximately RMB17.4 million as at June 30, 2026, primarily due to the increase in input VAT
arising from higher R&D expenditures during the Reporting Period.
Deposits and other receivables are miscellaneous expenses including rental and other deposits.
Our prepayments primarily relate to purchases of clinical trial services, amounting to approximately
RMB3.5 million for the six months ended June 30, 2026 (June 30, 2025: approximately RMB3.5
million).
Prepayments to suppliers as at June 30, 2026 are due within one year.
As at June 30, 2026, no impairment losses were provided for the Group’s prepayments, other
receivables and other assets.
Financial Assets at Fair Value through Profit and Loss – non-current
The non-current portion of financial assets at FVPL of the Group, which primarily comprised the
Group’s investment in NASDAQ-listed shares of Sagimet, increased from RMB56.4 million as at
December 31, 2025 to approximately RMB68.7 million as at June 30, 2026, primarily due to the
appreciation in Sagimet’s quoted share price during the period.
Financial Assets at Fair Value through Profit and Loss – current
The current portion of financial assets at FVPL of the Group decreased from approximately
RMB26.1 million as at December 31, 2025 to approximately RMB24.9 million as at June 30, 2026,
primarily due to decreased investment in wealth management products.
Cash and Bank Balances
The following table sets forth the components of the Group’s time deposits and cash and cash
equivalents as at the dates indicated:
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Time deposits
Cash and cash equivalents
1,616,939
593,371
431,259
1,443,513
Total
2,210,310
1,874,772
17
Time deposits with original maturity over three months are made for varying periods depending
on our immediate cash requirements, and earn interest at the respective time deposit rates. Cash
and cash equivalents and time deposits earn interest at floating rates based on daily bank deposit
rates and the respective time deposit rates. The cash and cash equivalents and time deposits are
deposited with creditworthy banks with no recent history of default.
Trade Payables
Trade payables of the Group primarily consisted of payments to raw materials suppliers. The
following table sets forth the component of trade payables as at the dates indicated:
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Trade payables
14,623
1,344
Total
14,623
1,344
The following table sets forth an ageing analysis of the trade payables as at the dates indicated,
which is based on invoice date:
Within 3 months
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
14,623
1,344
Other Payables and Accruals
The following table sets forth the components of other payables and accruals outstanding as at the
dates indicated:
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Accrued expenses
Other payables
Payroll payable
Provisions
Taxes other than income tax
101,785
36,569
16,577
4,038
217
69,375
30,630
17,217
4,038
529
Total
159,186
121,789
18
The accrued expenses as at June 30, 2026 mainly represented the accrued R&D expenses actually
incurred but not yet invoiced. The accrued expenses increased from approximately RMB69.4
million as at December 31, 2025 to approximately RMB101.8 million as at June 30, 2026. The
accrued expenses are non-interest-bearing and due within one year.
Our other payables remained relatively stable and increased from approximately RMB30.6 million
as at December 31, 2025 to approximately RMB36.6 million as at June 30, 2026.
The payroll payable represented the accrued salary and bonus for the first half of 2026, which are
due within one year. The decrease in our payroll payable from approximately RMB17.2 million as
at December 31, 2025 to approximately RMB16.6 million as at June 30, 2026 was primarily due to
the decreased accrued salary and bonus.
The provisions remained unchanged at approximately RMB4.0 million as at both December 31,
2025, and June 30, 2026.
Deferred Income
The deferred income of the Group represented the unamortised portion of government grants
received in the Group’s Chinese Mainland subsidiaries to compensate such entities for the cost of
assets, which is subsequently recognised as income in profit or loss over the useful lives of the
relevant assets. The following table sets forth the deferred income as of the dates indicated:
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Government grants
– Current
– Non-current
1,588
1,588
1,588
2,382
Total
3,176
3,970
Liquidity and Capital Resources
The primary uses of cash of the Group are to fund its R&D activities, purchase of equipment
and raw materials and other recurring expenses. During the Reporting Period, the Group funded
its working capital and other capital expenditure requirements by the proceeds from the Global
Offering, top-up placing and placing under the general mandate.
19
The following table sets forth a condensed summary of the Group’s consolidated statement of
cash flows for the periods indicated and analysis of balances of cash and cash equivalents for the
periods indicated:
For the
For the
six months
six months
ended June 30, ended June 30,
2026
2025
(Unaudited)
(Unaudited)
RMB ’000
RMB ’000
Net cash used in operating activities
Net cash (used in)/generated from investing activities
Net cash generated from/(used in) financing activities
Net (decrease)/increase in cash and cash equivalents
Cash and cash equivalents at beginning of period
Effect of foreign exchange rate changes, net
Cash and cash equivalents at end of period
(327,349)
(1,192,401)
708,762
(810,988)
1,443,513
(39,154)
(172,990)
904,605
(14,485)
717,130
864,326
(1,116)
593,371
1,580,340
As at June 30, 2026, cash and cash equivalents were mainly denominated in Renminbi and United
States dollars.
Operating Activities
Our cash inflows from operating activities mainly consisted of trade receivables received from
customers and government grants, and to date, government grants received by the Group have
originated exclusively from Chinese Mainland entities and the Australian entity, with no such
grants received from Hong Kong entities. Our cash outflows for operating activities mainly
consisted of payment of R&D costs and administrative expenses.
For the six months ended June 30, 2026, we had net cash used in operating activities of approximately
RMB327.3 million, primarily as a result of operating loss before changes in working capital of
approximately RMB358.3 million. The changes in working capital were mainly due to payment of
R&D costs.
Investing Activities
Our cash used in investing activities mainly consisted of purchase of time deposits with original
maturity of over three months, purchase of property, plant and equipment, purchase of intangible
assets and purchase of financial assets at FVPL.
20
For the six months ended June 30, 2026, our net cash used in investing activities was approximately
RMB1,192.4 million, primarily due to the increase in time deposits with original maturity of over
three months of approximately RMB1,194.1 million.
Financing Activities
Our cash generated from financing activities primarily related to proceeds from placing new shares
under general mandate.
For the six months ended June 30, 2026, our net cash generated from financing activities was
approximately RMB708.8 million, primarily attributable to proceeds from placing new shares
under general mandate of approximately RMB742.3 million.
Capital Expenditures
The principal capital expenditures of the Group primarily consisted of the purchase of office
equipment and plant and machinery. The following table sets forth our net capital expenditures as
at the dates indicated:
June 30,
2026
(Unaudited)
RMB ’000
December 31,
2025
(Audited)
RMB ’000
Office equipment
Plant and machinery
9
1,224
872
468
Total
1,233
1,340
Our capital expenditures decreased by 8.0% from approximately RMB1.3 million as at December
31, 2025 to approximately RMB1.2 million as at June 30, 2026, primarily because we reduced the
purchase of the office equipment for laboratory renovation.
Significant Investments Held, Material Acquisitions and Disposals
Save as disclosed in this announcement, the Group did not have any significant investments required
to be disclosed under paragraph 32(4A) of Appendix D2 to the Listing Rules, and any material
acquisitions or disposals of subsidiaries and associate companies for the six months ended June 30,
2026.
Indebtedness
Borrowings, Charges of Assets and Guarantees
As at June 30, 2026, the Group did not have any outstanding mortgages, charges, debentures,
other issued debt capital, bank overdrafts, borrowings, liabilities under acceptance or other similar
indebtedness, any guarantees or other material contingent liabilities.
21
Contingent Liabilities
(a)
Viking case
On December 29, 2022, Viking Therapeutics, Inc. (“Viking”), a pharmaceutical company
in the United States, filed certain complaints against the Company, its founder Jinzi Jason
WU and certain subsidiaries of the Company in connection with the Group’s drug candidates
ASC41 and ASC43F. One complaint was made with the United States International Trade
Commission, Washington D.C. (the “ITC”) and another complaint was made with the United
States District Court, Southern District of California, (the “USDC”) San Diego Division, each
covering similar allegations.
The Company received initial determination and final judgment (together the “Judgment”)
from ITC on the complaint on October 4, 2024 and May 29, 2025. The Judgment, made
by an Administrative Law Judge of the ITC, found a violation of Section 337 of the Tariff
Act of 1930 (as amended) in the importation of the Company’s drug candidates ASC41 and
ASC43F into the United States. In addition, a monetary sanction of USD567,000 (equivalent
to approximately RMB4,038,000) was proposed due to certain procedural issues during the
investigation phase. The Company has made a provision for this monetary sanction in the
financial statements.
Regarding the complaint made with USDC, there has been no major progress since January
1, 2026, and the relevant investigation and litigation proceedings are ongoing. The Company
will vigorously defend against the complaint. Accordingly, the Group has not made any
provision for the allegations arising from the complaint made with USDC filed by Viking as
at June 30, 2026.
(b)
Arbitration case
In September 2025, Ascletis Pharmaceuticals became involved in an arbitration proceeding
initiated by a previous customer due to commercial contracts dispute on sales of certain
products.
The claimant seeks compensation in an aggregate amount around RMB25 million, comprising
(i) contract payments, (ii) interest on the alleged occupied funds, and (iii) arbitration and
legal fees.
As at the date of this announcement, the arbitration is ongoing and no ruling has been issued.
Based on the information currently available, the outcome of the arbitration and its potential
financial impact on the Group cannot be reliably estimated. As at June 30, 2026, the Group
has not made any provision for the arbitration.
Charges of Assets
As at June 30, 2026, the Group had no charge on its assets.
22
Contractual Commitments
We leased certain of our properties and warehouse under operating lease arrangements. Leases for
properties and warehouse are negotiated for terms ranging mainly from one to three years.
The Group had approximately RMB3.2 million of capital commitments as at June 30, 2026 and
approximately RMB0.6 million of capital commitments as at December 31, 2025.
Key Financial Ratios
The following table sets forth our key financial ratios as of the dates indicated:
Current ratio(1)
Quick ratio(2)
Gearing ratio(3)
As at
June 30,
2026
(Unaudited)
As at
December 31,
2025
(Audited)
12.9
12.9
7.4%
15.1
15.0
6.4%
Notes:
(1)
Current ratio represents current assets divided by current liabilities as of the same date.
(2)
Quick ratio represents current assets less inventories and divided by current liabilities as of the same date.
(3)
Gearing ratio represents total liabilities divided by total assets as of the same date and multiplied by 100%.
Our current ratio decreased from 15.1 as at December 31, 2025 to 12.9 as at June 30, 2026, and our
quick ratio decreased from 15.0 as at December 31, 2025 to 12.9 as at June 30, 2026, primarily due
to an increase in current liabilities.
Our gearing ratio increased from 6.4% as at December 31, 2025 to 7.4% as at June 30, 2026, primarily
due to an increase in current liabilities.
Foreign Exchange Risk
Foreign currency risk refers to the risk of loss resulting from changes in foreign currency exchange
rates. Fluctuations in exchange rates between Renminbi and other currencies in which our Group
conducts business may affect our financial condition and results of operation.
The Group mainly operates in the PRC and is exposed to foreign exchange risk arising from
various currency exposures, primarily with respect to the USD. Foreign exchange risk arises from
recognized assets and liabilities in foreign operations. The conversion of Renminbi from foreign
currencies, including the USD, has been based on rates set by the People’s Bank of China. The
Group seeks to limit its exposure to foreign currency risk by closely monitoring and minimizing
its net foreign currency position. During the Reporting Period, the Group did not enter into any
currency hedging transactions.
23
Employees and Remuneration Policies
The emoluments of the Directors and senior management of the Group are decided by the Board
with reference to the recommendation given by the Remuneration Committee, having regard to
the Group ’ s operating results, salaries paid by comparable companies, time commitment and
responsibilities and employment conditions of the Directors and senior management.
As at June 30, 2026, the Group had a total of 217 employees, most of which were located in the
PRC. Over 79.7% of our employees obtained a bachelor’s degree or higher. The table below sets
forth our Group’s employees by function as disclosed:
As at June 30, 2026
Numbers of
employees
% of total
Management
R&D
Manufacturing
Operations
3
149
32
33
1.4
68.7
14.7
15.2
Total
217
100.0
The Group’s total staff costs for the six months ended June 30, 2026 were approximately RMB68.4
million, compared to approximately RMB82.1 million for the six months ended June 30, 2025.
The Group recruits employees through recruitment websites, recruiters, internal referral and job
fairs. The Group conducts new employee training, as well as professional and compliance training
programs for employees.
The Group enters into employment contracts with employees to cover matters such as wages,
benefits and grounds for termination. The remuneration package of our employees includes salary
and bonus, which are generally determined by the qualifications, industry experience, position and
performance. The Group makes contributions to social insurance and housing provident funds for
our employees as required by the PRC laws and regulations.
The Group also has adopted the share schemes under Chapter 17 of the Listing Rules to provide
incentives to employees for their persistent devotion in achieving long-term growth of the Group.
24
CONSOLIDATED STATEMENT OF PROFIT OR LOSS
For the six months ended 30 June 2026 – unaudited
Note
Revenue
Cost of sales
3
Gross profit
4
Other income and gains
Research and development costs
Administrative expenses
Other expenses
Loss from operations
Finance costs
2026
RMB ’000
2025
RMB ’000
–
–
1,081
(960)
–
121
52,979
(341,663)
(30,803)
(12)
102,496
(146,812)
(43,302)
(367)
(319,499)
(87,864)
(74)
(87)
Loss before taxation
5
(319,573)
(87,951)
Income tax
6
(98)
–
Loss for the period
(319,671)
(87,951)
Attributable to:
Equity shareholders of the Company
(319,671)
(87,951)
RMB
(30.74) cents
RMB
(9.14) cents
Loss per share
7
Basic and diluted
25
CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE
INCOME
For the six months ended 30 June 2026 – unaudited
2026
RMB ’000
2025
RMB ’000
(319,671)
(87,951)
7,850
247
Items that will not be reclassified to profit or loss:
Exchange differences on translation of the Company’s
financial statements into presentation currency
(65,026)
(5,546)
Other comprehensive income for the period
(57,176)
(5,299)
Total comprehensive loss for the period
(376,847)
(93,250)
Attributable to:
Equity shareholders of the Company
(376,847)
(93,250)
Loss for the period
Other comprehensive income for the period (after tax)
Items that are or may be reclassified subsequently
to profit or loss:
Exchange differences on translation
of foreign operations
26
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
At 30 June 2026 – unaudited
30 June
2026
RMB ’000
31 December
2025
RMB ’000
8
35,362
39,625
9
177
4,926
9,383
259
7,077
10,285
38,007
31,733
68,687
376
56,367
460
156,918
145,806
1,169
–
24,897
26,212
32,164
593,371
1,874
223
26,103
17,747
–
1,443,513
1,616,939
431,259
2,294,752
1,920,719
14,623
159,186
2,240
1,588
1,344
121,789
2,871
1,588
177,637
127,592
Net current assets
2,117,115
1,793,127
Total assets less current liabilities
2,274,033
1,938,933
Note
Non-current assets
Property, plant and equipment
Advance payments for property, plant and
equipment
Right-of-use assets
Other intangible assets
Financial assets at fair value through other
comprehensive income (“FVOCI”)
Financial assets at fair value through profit
or loss (“FVPL”)
Long-term deferred expenditure
Current assets
Inventories
Trade receivables
Financial assets at FVPL
Prepayments, other receivables and other assets
Financial assets at FVOCI
Cash and cash equivalents
Time deposits with original maturity over
three months
10
Current liabilities
Trade payables
Other payables and accruals
Lease liabilities
Deferred income
11
27
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (CONTINUED)
At 30 June 2026 – unaudited
30 June
2026
RMB ’000
31 December
2025
RMB ’000
1,496
1,588
2,287
2,382
3,084
4,669
NET ASSETS
2,270,949
1,934,264
CAPITAL AND RESERVES
Share capital
Reserves
727
2,270,222
679
1,933,585
Total equity attributable to equity
shareholders of the Company
2,270,949
1,934,264
TOTAL EQUITY
2,270,949
1,934,264
Non-current liabilities
Lease liabilities
Deferred income
28
NOTES TO THE UNAUDITED INTERIM FINANCIAL REPORT
1.
CORPORATE INFORMATION
The Company is a limited liability company incorporated in the Cayman Islands on 25 February 2014. The
registered office address of the Company is located at 190 Elgin Avenue, George Town, Grand Cayman
KY1-9008, Cayman Islands. The principal place of business in Hong Kong of the Company is located at 40th
Floor, Dah Sing Financial Centre, No. 248 Queen’s Road East, Wanchai, Hong Kong.
The Company is an investment holding company. The Company’s subsidiaries are principally engaged in the
research and development of pharmaceutical products.
The shares of the Company were listed on the Main Board of the Stock Exchange of Hong Kong Limited (the
“Stock Exchange”) on 1 August 2018.
2.
BASIS OF PREPARATION AND CHANGES IN ACCOUNTING POLICIES AND DISCLOSURES
2.1
BASIS OF PREPARATION
This interim financial report has been prepared in accordance with the applicable disclosure provisions of the
Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited, including compliance
with Hong Kong Accounting Standard (“HKAS”) 34, Interim financial reporting , issued by the Hong Kong
Institute of Certified Public Accountants (“HKICPA”). It was authorised for issue on 31 August 2026.
The interim financial report has been prepared in accordance with the same accounting policies adopted in the
2025 annual financial statements, except for the accounting policy changes that are expected to be reflected in
the 2026 annual financial statements. Details of any changes in accounting policies are set out in Note 2.2.
The preparation of an interim financial report in conformity with HKAS 34 requires management to make
judgements, estimates, and assumptions that affect the application of policies and reported amounts of assets
and liabilities, income, and expenses on a year-to-date basis. Actual results may differ from these estimates.
This interim financial report contains condensed consolidated financial statements and selected explanatory
notes. The notes include an explanation of events and transactions that are significant to an understanding of
the changes in financial position and performance of the Group since the 2025 annual financial statements.
The condensed consolidated interim financial statements and the accompanying notes do not include all of the
information required for a full set of financial statements prepared in accordance with HKFRS Accounting
Standards.
The interim financial report is unaudited, but has been reviewed by KPMG in accordance with Hong Kong
Standard on Review Engagements 2410, Review of interim financial information performed by the independent
auditor of the entity , issued by the HKICPA.
2.2
CHANGES IN ACCOUNTING POLICIES AND DISCLOSURES
The HKICPA has issued a number of amendments to HKFRS Accounting Standards that are first effective for
the current accounting period, including:
•
Amendments to HKFRS 9, Financial instruments and HKFRS 7, Financial instruments: disclosures –
Contracts referencing nature dependent electricity
•
Amendments to HKFRS 9, Financial instruments and HKFRS 7, Financial instruments: disclosures –
Amendments to the classification and measurement of financial instruments
•
Annual improvements to HKFRSs – Volume 11
These amendments do not have a material financial impact on this interim report as the Group has not entered
into such transactions.
The Group has not applied any new standard or interpretation that is not yet effective for the current accounting
period.
29
3.
REVENUE AND SEGMENT REPORTING
(a)
Revenue
(i)
Disaggregation of revenue
Disaggregation of revenue from contracts with customers by products or service lines is as follows:
For the six months ended 30 June
2026
2025
RMB ’000
RMB ’000
Revenue from contracts with customers within
the scope of IFRS 15
(b)
Recognised over time:
– Provide R&D service
– Others
–
–
1,054
27
Total
–
1,081
Segment reporting
Operating segments are identified on the basis of internal reports that the Group’s most senior executive
management reviews regularly in allocating resources to segments and in assessing their performances.
The Group’s most senior executive management makes resources allocation decisions based on internal
management functions and assess the Group’s business performance as one integrated business instead
of by separate business lines or geographical regions. Accordingly, the Group has only one operating
segment and therefore, no segment information is presented.
(c)
Geographical information
The following table sets out information about the geographical location of (i) the Group’s revenue from
external customers and (ii) the Group’s property, plant and equipment and intangible assets (“specified
non-current assets”). The geographical location of customers is based on their operating location. The
geographical location of the specified non-current assets is based on the physical location of the asset, in
the case of property, plant and equipment, and the location of the operation to which they are allocated,
in the case of intangible assets.
(i)
Revenue from external customers
For the six months ended 30 June
2026
2025
RMB ’000
RMB ’000
(ii)
Hong Kong
Other region
–
–
1,054
27
Total
–
1,081
30 June
2026
RMB ’000
31 December
2025
RMB ’000
Chinese Mainland
United States
44,741
4
49,906
4
Total
44,745
49,910
Non-current assets
30
4.
OTHER INCOME AND GAINS
For the six months ended 30 June
2026
2025
RMB ’000
RMB ’000
Bank interest income
Net realized and unrealized gains arising from equity investment
Net realized and unrealized gains arising from wealth
management products and structured deposits
Net realized and unrealized gains on financial assets at FVOCI
Government grants (i)
Foreign exchange loss, net
Others
39,466
17,336
30,037
37,679
3,643
709
1,188
(10,110)
747
1,472
431
34,175
(1,308)
10
Total
52,979
102,496
Note:
(i)
5.
The government grants mainly represent subsidies received from the local governments for the purpose
of compensation for expenses arising from research activities, clinical trials and daily operating activities
and capital expenditure incurred on certain projects, and awarding the new drug development.
LOSS BEFORE TAX
The Group’s loss before tax is arrived at after charging/(crediting):
(a)
Finance cost
For the six months ended 30 June
2026
2025
RMB ’000
RMB ’000
74
Interest on lease liabilities
(b)
87
Other items
For the six months ended 30 June
2026
2025
RMB ’000
RMB ’000
Depreciation of items of property, plant and equipment
Depreciation of right-of-use assets
Amortisation of intangible assets
Write-down of inventories to net realisable value
Auditor’s remuneration
Lawsuit expenses
Equity-settled share award and option expense
6.
5,469
2,151
953
16
551
836
3,274
5,470
2,756
1,214
23
551
1,899
3,836
INCOME TAX
The Group is subject to income tax on an entity basis on profits arising in or derived from the jurisdictions in
which members of the Group are domiciled and operated.
Cayman Islands
Under the current laws of the Cayman Islands, the Company is not subject to tax on income or capital gains. In
addition, upon payments of dividends by the Company to its shareholders, no Cayman Islands withholding tax is
imposed.
31
British Virgin Islands
Under the current laws of the British Virgin Islands (“BVI”), PowerTree Investment (BVI) Ltd. (“PowerTree”)
is not subject to tax on income or capital gains. In addition, upon payments of dividends by PowerTree to its
shareholder, no BVI withholding tax is imposed.
Hong Kong
Under the current laws of Hong Kong, the subsidiary in Hong Kong is subject to profits tax at a rate of 16.5%
(2025: 16.5%) on the estimated assessable profits arising in Hong Kong. During the reporting period, no
provision for profits tax has been made as the subsidiary did not generate any assessable profits in Hong Kong.
The United States
Under the current laws of the United States, the subsidiary in the United States is subject to tax at a maximum
of 21% (2025: 21%) federal corporate income tax rate and 2.5% (2025: 2.5%) North Carolina state tax rate.
During the reporting period, no provision for income tax has been made as the subsidiary did not generate any
assessable income in United States.
Australia
Under the current laws of Australia, the subsidiary in the Australia is subject to profits tax at a rate of 30%
(2025: 30%). During the reporting period, no provision for income tax has been made as the subsidiary did not
generate any assessable income in Australia.
Chinese Mainland
Pursuant to the Corporate Income Tax Law of the PRC and the respective regulations (the “CIT Law”), the
subsidiaries which operate in Chinese Mainland are subject to CIT at a rate of 25% (2025: 25%) on the taxable
income.
Pursuant to the CIT Law, non-resident enterprises without an establishment or place of business in the PRC
or which have an establishment or place of business in the PRC but whose relevant income is not effectively
connected with the establishment or a place of business in the PRC, will be subject to withholding tax at the rate
of 10% (unless reduced by treaty) on various types of passive income such as dividends derived from sources
within the PRC.
Preferential tax treatment is available to Ascletis Pharmaceuticals Co., Ltd. (“Ascletis Pharmaceuticals”) (歌禮
藥業(浙江)有限公司) since it was recognised as a High and New Technology Enterprise, and it was entitled to
a preferential tax rate of 15% (2025: 15%) during the reporting period.
Certain subsidiaries in the PRC were entitled to a preferential PRC CIT rate of 5% as they were accredited as
small and micro business.
According to the new tax incentive policies promulgated by the State Taxation Administration of the PRC in
March 2023, effective from 1 January 2023, an additional 100% of qualified research and development expenses
incurred is allowed to be deducted from taxable income.
7.
LOSS PER SHARE
The calculation of basic loss per share is based on the loss attributable to ordinary equity shareholders of the
Company of RMB319,671,000 (six months ended 30 June, 2025: RMB87,951,000) and the weighted average
of 1,039,794,415 ordinary shares (six months ended 30 June, 2025: 962,522,870) in issue during the interim
period.
No adjustment has been made to the basic loss per share amounts presented for the periods ended 30 June, 2026
and 2025 in respect of a dilution as the impact of the share award and options had an anti-dilutive effect on the
basic loss per share amounts presented.
32
8.
PROPERTY, PLANT AND EQUIPMENT
During the six months ended 30 June, 2026, the Group acquired assets at a cost of RMB1,233,000 (six months
ended 30 June, 2025: RMB1,072,000).
Items of plant and machinery with a net book value of RMB9,000 were disposed of during the six months ended
30 June, 2026 (six months ended 30 June, 2025: RMB50,000), resulting in a loss on disposal of RMB9,000 (six
months ended 30 June, 2025: RMB50,000).
9.
RIGHT-OF-USE ASSETS
During the six months ended 30 June, 2026, the Group did not enter into any new office occupancy lease
agreements, and therefore no additions to right-of-use assets were recognised in the period (six months ended 30
June, 2025: RMB2,121,000).
10.
TRADE RECEIVABLES
As of the end of the reporting period, the ageing analysis of the trade receivables, based on the invoice date and
net of loss allowance, is as follows:
Within 3 months
11.
30 June
2026
RMB ’000
31 December
2025
RMB ’000
–
223
TRADE PAYABLES
As of the end of the reporting period, the ageing analysis of the trade payables, based on the invoice date, is as
follows:
Within 3 months
12.
30 June
2026
RMB ’000
31 December
2025
RMB ’000
14,623
1,344
CAPITAL, RESERVES AND DIVIDENDS
(a)
Dividends
The board of directors does not recommend the payment of any dividend in respect of the six months
ended 30 June, 2026 (six months ended 30 June, 2025: nil).
(b)
Share capital
(i)
Issued share capital
2026
No. of shares
Ordinary shares, issued and fully paid:
At 1 January
Shares cancelled
Issuance of shares
At 30 June
RMB ’000
2025
No. of shares
RMB ’000
998,958,530
–
69,496,525
679
–
48
1,012,758,000
(44,896,790)
1,569,285
689
(32)
1
1,068,455,055
727
969,430,495
658
The par value of the ordinary shares of the Company is US$0.0001 each.
33
(ii)
Repurchase of own shares
During the interim period, the Company repurchased its own shares on the Stock Exchange as follows:
Month/year
Number
of shares
repurchased
Highest
price paid
per share
HKD
Lowest
price paid
per share
HKD
Aggregate price
paid (including
transaction fee)
HKD ’000
June 2026
3,745,000
10.77
9.14
37,300
The total amount paid on the repurchased shares of HKD37,300,000 (equivalent to RMB32,438,000) was
fully paid.
(iii)
Cancellation of share repurchased
During the six months ended 30 June, 2026, the Company did not cancel any repurchased shares (six
months ended 30 June, 2025: 44,896,790 shares).
(iv)
Shares issued under share option scheme
During the six months ended 30 June, 2026, options were exercised to subscribe for 240,525 (six months
ended 30 June, 2025: 1,569,285) ordinary shares in the Company at a consideration of RMB371,000 (six
months ended 30 June, 2025: RMB3,849,000). Less than RMB1,000 (six months ended 30 June, 2025:
RMB1,000) was credited to share capital and an amount of RMB371,000 (six months ended 30 June,
2025: RMB3,848,000) was credited to capital reserve.
(v)
Placement of new shares
On 10 February 2026, the Company successfully allotted and issued a total of 69,256,000 new shares
(the “Placing Shares”) to not less than six placees who and whose ultimate beneficial owners are third
parties independent of and not connected with the Company, connected persons of the Company and any
of the directors, supervisors, chief executive or substantial shareholder(s) of the Company or any of its
subsidiaries or their respective associates at a placing price of HK$12.18 per Placing Share. The Placing
Shares represented approximately 6.53% of the total number of issued shares as enlarged by the allotment
and issue of the Placing Shares. The net proceeds (after deduction of the commissions and estimated
expenses) from the placing were approximately HK$835.2 million (equivalent to RMB742.3 million). For
more details, please refer to the announcement of the Company dated 10 February 2026.
(c)
Equity settled share-based transactions
On 3 February 2025, the Company adopted a share option scheme (the “2025 Share Option Scheme”)
and a share award scheme (the “2025 Share Award Scheme”). The purpose of these schemes is to
reward directors and employees for their service to the Group and to provide incentives to them to further
contribute to the Group.
Each option gives the holder the right to subscribe for one ordinary share of the Company. These share
options will vest from 14 January 2026 to 14 January 2029, and then be exercisable until 2035. The share
awards will vest conditional upon the fulfilment of the specific performance targets.
During the six months ended 30 June, 2026, no share options or share awards were granted by the
Company (six months ended 30 June, 2025: 4,820,175 share options and 5,784,210 share awards).
34
13.
CONTINGENT LIABILITIES
(a)
Viking case
On 29 December 2022, Viking Therapeutics, Inc. (“Viking”), a pharmaceutical company in the United
States, filed certain complaints against the Company, its founder Jinzi Jason WU and certain subsidiaries
of the Company in connection with the Group’s drug candidates ASC41 and ASC43F. One complaint was
made with the United States International Trade Commission, Washington D.C. (the “ITC”) and another
complaint was made with the United States District Court, Southern District of California, (the “USDC”)
San Diego Division, each covering similar allegations.
The Company received initial determination and final judgment (together the “Judgment”) from ITC on
the complaint on 4 October 2024 and 29 May 2025. The Judgment, made by an Administrative Law Judge
of the ITC, found a violation of Section 337 of the Tariff Act of 1930 (as amended) in the importation
of the Company’s drug candidates ASC41 and ASC43F into the United States. In addition, a monetary
sanction of USD567,000 (equivalent to approximately RMB4,038,000) was proposed due to certain
procedural issues during the investigation phase. The Company has made a provision for this monetary
sanction in the financial statements.
Regarding the complaint made with USDC, there has been no major progress since 1 January 2026, and
the relevant investigation and litigation proceedings are ongoing. The Company will vigorously defend
against the complaint. Accordingly, the Group has not made any provision for the allegations arising from
the compliant made with USDC filed by Viking as at 30 June, 2026.
(b)
Arbitration case
In September 2025, Ascletis Pharmaceuticals became involved in an arbitration proceeding initiated by a
previous customer due to commercial contracts dispute on sales of certain products.
The claimant seeks compensation in an aggregate amount around RMB25 million, comprising (i) contract
payments, (ii) interest on the alleged occupied funds, and (iii) arbitration and legal fees.
As at the date of this announcement, the arbitration is ongoing and no ruling has been issued. Based on
the information currently available, the outcome of the arbitration and its potential financial impact on
the Group cannot be reliably estimated. As at 30 June, 2026, the Group has not made any provision for
the arbitration.
35
COMPLIANCE WITH THE CORPORATE GOVERNANCE CODE
The Company is committed to maintaining high standard of corporate governance to safeguard
the interests of the Shareholders, enhance corporate value, formulate its business strategies and
policies, and enhance its transparency and accountability.
The Company has adopted the code provisions of the CG Code as set out in Appendix C1 to the
Listing Rules as its own code of corporate governance.
The Board is of the view that the Company has complied with all applicable code provisions of the
CG Code during the Reporting Period, except for a deviation from the code provision C.2.1 of part
2 of the CG Code, the roles of chairman of the Board and chief executive officer of the Company
are not separate and are both performed by Dr. Wu. The Company is an investment holding
company with a professional management team to monitor the operations of the subsidiaries. The
Board considers that vesting the roles of chairman of the Board and chief executive officer in
the same person is more efficient in the direction and management of the Company and does not
impair the balance of power and authority of the Board and the management of the business of the
Company. The Board will review the corporate governance structure and practices from time to
time and shall make necessary arrangements when the Board considers appropriate.
COMPLIANCE WITH THE MODEL CODE FOR SECURITIES TRANSACTIONS
The Company has adopted the Written Guidelines on no less exacting terms than the Model Code
as its own code of conduct regarding securities transactions by the Directors.
Having made specific enquiry of all Directors, all of them have confirmed that they have complied
with the Model Code and the Written Guidelines throughout the Reporting Period and up to the
date of this announcement. No incident of non-compliance with the Written Guidelines by the
employees who are likely to be in possession of inside information of the Company was noted by
the Company during the Reporting Period.
PURCHASE, SALE OR REDEMPTION OF THE LISTED SECURITIES OF THE
COMPANY
The Company repurchases Shares from time to time for the purposes of enhancing shareholder
value in the long term and providing greater flexibility to the Board to resell the treasury shares
at prevailing market prices to raise additional funds for the Company, transfer or use the treasury
shares for share grants under share schemes that comply with Chapter 17 of the Listing Rules,
or use them for other purposes permitted under the Listing Rules, the Articles and the applicable
laws of the Cayman Islands. During the Reporting Period, the Company repurchased a total of 3,745,000
Shares on the Stock Exchange at an aggregate consideration of HK$37,227,010, mainly for the purpose
of enhancing the value of the Shares and thereby benefiting the Shareholders as a whole. During
the Reporting Period and up to the date of this announcement, the Company repurchased a total
of 5,745,000 Shares of the Company on the Stock Exchange at an aggregate consideration of
HK$55,954,050. As at the date of this announcement, 9,386,000 ordinary Shares repurchased for
cancellation and 1,300,000 treasury Shares have been cancelled and the total number of Shares in
issue has been reduced accordingly as at the date of this announcement.
Particulars of the Shares repurchased during the Reporting Period and up to the date of this
announcement are as follows:
36
Trading Month
Number and Method of
Shares Repurchased
June 2026
July 2026
3,745,000 on the Stock Exchange
2,000,000 on the Stock Exchange
Total
5,745,000
Price Per Share
Lowest
Highest
price paid
price paid
per Share
per Share
(HK$)
(HK$)
10.77
11.67
9.14
8.01
Aggregate
Consideration
Paid
(HK$)
37,227,010.00
18,727,040.00
55,954,050.00
Save for the above, during the Reporting Period and up to the date of this announcement, neither
the Company nor any of its subsidiaries has purchased, sold or redeemed any of the Company’s
listed securities (including sale of treasury shares).
As at June 30, 2026, for the purpose of the Listing Rules, the Company held 7,084,210 treasury
shares and such treasury shares are used for the share schemes of the Company, including the 2025
Share Award Scheme. For details, please refer to the announcement and circular of the Company
dated January 14, 2025 and January 15, 2025 respectively, and the poll results announcement of
the extraordinary general meeting of the Company dated February 3, 2025.
CHANGES IN DIRECTORS’ INFORMATION
During the Reporting Period, the Board has not been informed of any change in the Directors’
information required to be disclosed pursuant to Rule 13.51B(1) of the Listing Rules.
REVIEW OF INTERIM RESULTS
The independent auditor of the Company, namely, KPMG, has carried out a review of the interim
financial information in accordance with the Hong Kong Standard on Review Engagements 2410,
“Review of Interim Financial Information Performed by the Independent Auditor of the Entity”
issued by the Hong Kong Institute of Certified Public Accountants.
The Audit Committee comprises three independent non-executive Directors, namely, Mr. Jiong
GU, Dr. Yizhen WEI, and Ms. Lin HUA. The chairman of the Audit Committee is Mr. Jiong GU.
The Audit Committee has jointly reviewed with the management the accounting principles and
policies adopted by the Company 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. The Audit Committee considered that the interim results are in compliance with the
applicable accounting standards, laws and regulations, and the Company has made appropriate
disclosures thereof. There were no disagreements between the Board and the Audit Committee
regarding the selection, application and interpretation of accounting standards, the accounting
treatment adopted by the Company, or the interim financial information prepared and presented by
the management during the Reporting Period.
EVENTS AFTER THE REPORTING PERIOD
There are no significant subsequent events after the Reporting Period and up to the date of this
announcement.
37
INTERIM DIVIDEND
The Board does not recommend payment of an interim dividend for the six months ended June 30,
2026.
PUBLICATION OF INTERIM RESULTS AND INTERIM REPORT
This announcement is published on the website of the Stock Exchange (www.hkexnews.hk) and
the Company’s website (www.ascletis.com). The interim report for the six months ended June 30,
2026 containing all the information in accordance with the requirements under the Listing Rules
will be dispatched to the Shareholders who request printed copies and published on the respective
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.
38
DEFINITIONS
“2025 Share Option Scheme”
the 2025 Share Option Scheme adopted by the Company on
February 3, 2025
“2025 Share Award Scheme”
the 2025 Share Award Scheme adopted by the Company on
February 3, 2025
“Articles”
the articles of association of the Company
“Ascletis”, “Company”, “the
Company” or “We”
Ascletis Pharma Inc. (歌禮製藥有限公司), an exempted company
incorporated in the Cayman Islands with limited liability on
February 25, 2014
“Ascletis BioScience”
Ascletis BioScience Co., Ltd. (歌禮生物科技(杭州)有限公司),
a limited liability company established in the PRC on April 26,
2013 and an indirectly wholly-owned subsidiary of the Company
“Ascletis Pharma (China)”
Ascletis Pharma (China) Co., Limited (歌禮製藥(中國)有限公
司), a company incorporated in Hong Kong with limited liability
on March 15, 2018 and an indirectly wholly-owned subsidiary of
the Company
“Ascletis Pharmaceuticals”
Ascletis Pharmaceuticals Co., Ltd. (歌禮藥業(浙江)有限公司),
a limited liability company established in the PRC on September
24, 2014 and an indirectly wholly-owned subsidiary of the
Company
“Audit Committee”
the audit committee of the Board
“Board” or “Board of
Directors”
the board of directors of the Company
“cAMP”
cyclic adenosine monophosphate
“CG Code”
the Corporate Governance Code as set out in Appendix C1 to the
Listing Rules
“Chairman”
the chairman of the Board
“China”, “Chinese Mainland”
or “the PRC”
the People’s Republic of China, excluding, for the purpose of this
announcement, Hong Kong, Macau Special Administrative Region
and Taiwan
“Director(s)”
the director(s) of the Company
“DIO”
diet-induced obese
“Dr. Wu”
Dr. Jinzi Jason WU (吳勁梓), the founder, chairman of the Board,
chief executive officer and one of the controlling shareholders of
the Company and the spouse of Mrs. Judy Hejingdao Wu
39
“EMA”
European Medicines Agency
“FASN”
fatty acid synthase
“FDA”
U.S. Food and Drug Administration
“FDC”
fixed-dose combination
“FVOCI”
fair value through other comprehensive income
“FVPL”
fair value through profit or loss
“GCGR”
glucagon receptor
“GIPR”
gastric inhibitory polypeptide receptor
“GLP-1R”
glucagon-like peptide 1 receptor
“Group”, “our Group” or
“the Group”
the Company and its subsidiaries
“hAMY1R”
human amylin 1 receptor
“hCTR”
human calcitonin receptor
“HK$” or “HKD”
Hong Kong dollars, the lawful currency of Hong Kong
“Hong Kong”
the Hong Kong Special Administrative Region of the PRC
“IL-17A and F”
interleukin-17A and F
“IND(s)”
investigational new drug(s), (an) experimental drug for which
a pharmaceutical company obtains permission to ship across
jurisdictions (usually to clinical investigators) before a marketing
application for the drug has been approved
“Listing Rules”
the Rules Governing the Listing of Securities on the Stock
Exchange, as amended or supplemented from time to time
“MAA”
Marketing Authorisation Application
“Main Board”
the Main Board of the Stock Exchange
“Model Code”
the Model Code for Securities Transactions by Directors of Listed
Issuers contained in Appendix C3 to the Listing Rules
“NDA”
New Drug Application
“NHP(s)”
non-human primate
40
“NMPA”
China National Medical Products Administration
“Option(s)”
share option(s) granted to a grantee to subscribe for Shares
pursuant to the terms of the 2025 Share Option Scheme
“QD”
once daily
“R&D”
research and development
“Renminbi” or “RMB”
Renminbi Yuan, the lawful currency of China
“Reporting Period”
the six-month period from January 1, 2026 to June 30, 2026
“SAD”
single ascending dose
“Sagimet”
Sagimet Biosciences Inc., a corporation incorporated in Delaware
in December 2006, whose shares are listed on the Nasdaq Stock
Market (stock code: SGMT)
“SALD”
Self-Assembling Lipid Depot
“Share(s)”
ordinary shares in the share capital of our Company of US$0.0001
each
“Share Award(s)”
Share award(s) granted to a Grantee to subscribe for Shares
pursuant to the terms of the 2025 Share Award Scheme
“Shareholder(s)”
holder(s) of Shares
“SQ”
subcutaneous
“STAT6”
Signal Transducer and Activator of Transcription 6
“Stock Exchange”
The Stock Exchange of Hong Kong Limited
“U.S.”
United States of America
“USD” or “US$”
United States dollars, the lawful currency of the United States of
America
“vs.”
versus
“Written Guidelines”
the Guidelines for Securities Transactions by Directors adopted
by the Company
“%”
per cent
41
In this announcement, the terms “associate ”, “connected person ”, “controlling shareholder ” and
“subsidiary ” shall have the meanings given to such terms in the Listing Rules, unless the context
otherwise requires.
By order of the Board
Ascletis Pharma Inc.
歌禮製藥有限公司
Jinzi Jason WU
Chairman
Hong Kong
August 31, 2026
As at the date of this announcement, the Board comprises Dr. Jinzi Jason WU and Mrs. Judy
Hejingdao WU, as executive Directors; and Dr. Yizhen WEI, Mr. Jiong GU and Ms. Lin HUA, as
independent non-executive Directors.
42
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,概不就因本公告全部或任何部分內容所產生或因依
賴該等內容而引致的任何損失承擔任何責任。
本公告載有涉及風險及不確定因素的前瞻性陳述。除過往事實陳述以外的所有陳述均為前瞻性
陳述。該等陳述涉及已知及未知風險、不確定因素及其他因素,當中若干風險及因素並非本公
司所能控制,其可導致實際業績、表現或成果與該等前瞻性陳述所明示或暗示者存在重大差
異。 閣下不應依賴前瞻性陳述作為未來事件的預測。本公司概不承擔更新或修訂任何前瞻性
陳述的責任,無論是否由於新資料、未來事件或其他因素所致。
Ascletis Pharma Inc.
歌禮製藥有限公司
(於開曼群島註冊成立的有限公司)
股份代號:1672
截至二零二六年六月三十日止六個月之中期業績公告
董事會謹此宣佈,本集團截至二零二六年六月三十日止六個月之未經審核綜合中
期業績連同二零二五年同期之比較數據如下。
財務概要
未經審核
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)
收入總額 (1)
研發成本
行政開支
其他開支
融資成本
除稅前虧損
所得稅
期內虧損
以下人士應佔:
本公司權益股東
每股虧損
基本及攤薄
附註:
(1)
本集團收入總額為收入、其他收入及收益。
1
變動
%
52,979
(341,663)
(30,803)
(12)
(74)
(319,573)
(98)
(319,671)
103,577
(146,812)
(43,302)
(367)
(87)
(87,951)
–
(87,951)
(48.9)
132.7
(28.9)
(96.7)
(14.9)
263.4
–
263.5
(319,671)
(87,951)
263.5
人民幣
人民幣
(30.74)分
(9.14)分
公司簡介
我們的願景
歌禮的願景是成為最具創新力的世界級生物醫藥公司,致力於解決代謝疾病尚未
被滿足的全球醫療需求。
概覽
於報告期內及直至本公告日期,本集團在代謝性疾病管線方面取得重大進展:
(i)
已針對ASC30長期體重管理適應症啟動了一項全球III期臨床項目,該項目由
兩項關鍵的多中心、隨機、雙盲、安慰劑對照的全球III期試驗(AURORA-1
和AURORA-2)組成,將在美國、歐洲和加拿大共入組約4,600名肥胖或超重
受試者。近期,ASC30用於長期體重管理的全球III期臨床項目已完成首例受
試者給藥。本集團預計將於二零二八年第三季度公佈ASC30 III期臨床項目
的頂線數據,預計將於二零二八年末前向FDA提交NDA,並預計將於二零
二九年初向EMA提交MAA。本集團擁有充足的在手現金,除覆蓋預計提交
的ASC30 NDA及MAA外,可支持運營至二零二九年。
(ii)
正在為期13週的美國II期研究中評估治療糖尿病的ASC30小分子GLP-1每日
一次口服片。預計將於二零二六年第三季度獲得頂線數據。
(iii) ASC39(一款潛在同類首創、與eloralintide類似的每日一次口服小分子胰淀
素選擇性受體激動劑(SARA))在臨床前模型中顯示出與eloralintide相似的胰
淀素選擇性與療效,預計將於二零二六年第三季度向FDA遞交ASC39口服片
的IND申請。
(iv) ASC30_39FDC(一款ASC30與ASC39的固定劑量複方製劑)已獲選定為臨床
開發候選藥物,預計將於二零二六年第三季度向FDA遞交ASC30_39FDC口
服片的IND申請。
(v)
ASC30_48FDC(一款ASC30與ASC48(一款潛在同類首創口服小分子GIPR
激動劑)的固定劑量複方製劑)已獲選定為臨床開發候選藥物,預計將於二
零二六年第四季度向FDA遞交ASC30_48FDC口服片的IND申請。
(vi) ASC30_48_39FDC(一款ASC30、ASC48與ASC39的固定劑量複方製劑)已獲選
定進行臨床開發,預計將於二零二六年第四季度向FDA遞交ASC30_48_39FDC
口服片的IND申請。
(vii) ASC36(一款治療肥胖症的每月一次至每季度一次、潛在同類最佳皮下注射
胰淀素受體激動劑)已獲得FDA的IND批准,預計將於二零二六年末前公佈
頂線藥代動力學數據。
(viii) ASC36 口服片(本公司首款口服胰淀素受體激動劑多肽)已向FDA遞交IND
申請,預計將於二零二六年第三季度啟動I期試驗。
2
(ix) ASC35(一款治療肥胖症的潛在同類最佳、每月一次皮下注射GLP-1R/GIPR
雙靶點激動劑多肽)已獲得FDA的IND批准,預計將於二零二六年末前公佈
頂線藥代動力學數據。
(x)
ASC36_35FDC(一款ASC36 與ASC35 的固定劑量複方製劑)已獲得FDA的
IND批准,預計將於二零二七年第一季度初公佈頂線藥代動力學數據。
(xi) ASC37注射劑(一款新一代每月一次皮下注射GLP-1R/GIPR/GCGR三靶點激
動劑多肽)已獲選定為臨床開發候選藥物,預計將於二零二六年第三季度向
FDA遞交ASC37注射劑的IND申請。
(xii) ASC37口服片已獲選定為臨床開發候選藥物,預計將於二零二六年第三季度
向FDA遞交ASC37口服片的IND申請。
(xiii) ASC36_37FDC(一款ASC36與ASC37的固定劑量複方製劑)已獲選定進行臨
床開發,預計將於二零二六年第三季度向FDA遞交ASC36_37FDC注射劑的
IND申請。
於報告期內及直至本公告日期,本集團在免疫性疾病管線方面取得重大進展:
(i)
ASC50為一款IL-17A口服小分子抑制劑,已完成健康受試者美國I期SAD研
究及輕度至中度斑塊狀銀屑病患者為期28 天的美國I期概念驗證研究(POC)
(200 mg QD)。人體數據表明,ASC50有望成為同類首創及同類最佳口服小
分子IL-17A抑制劑。
(ii)
ASC51 為一款強效、選擇性及每日一次口服STAT6 降解劑並已具備向FDA
提交IND申請條件的候選藥物。ASC51已完成FDA IND所需的全部準備研
究,並有望成為繼KT-62後同類第二款STAT6口服小分子降解劑。
(iii) ASC52有望成為同類最佳IL-17AA、AF及FF口服環肽拮抗劑,預計將於二
零二六年第四季度向FDA遞交IND。ASC52有望成為繼PN-881後同類第二
款IL-17AA、AF及FF口服環肽拮抗劑。
該等成就凸顯本集團強大的研發能力、卓越的執行力以及研發全球同類最佳 ╱ 全
球同類首創管線藥物以解決未被滿足臨床需求的長期承諾。
於二零二六年六月三十日,本集團現金及現金等價物、定期存款、可轉讓存單、
結構性存款及理財產品約為人民幣2,305.4百萬元(二零二五年六月三十日:約人
民幣1,827.9百萬元),可支持其運營直至二零二九年。
3
本集團的研發成本由截至二零二五年六月三十日止六個月的約人民幣146.8百萬元
增加132.7%至截至二零二六年六月三十日止六個月的約人民幣341.7百萬元。研
發開支大幅增加主要由於本集團對推進其全面代謝性疾病管線(包括小分子及多
肽)的戰略承諾。本集團的期內虧損由截至二零二五年六月三十日止六個月的約
人民幣88.0百萬元增加263.5%至截至二零二六年六月三十日止六個月的約人民幣
319.7百萬元,主要由於上述研發成本增加。
於報告期內及直至本公告日期,本集團的管線及其進展概述如下:
4
代謝性疾病管線 - 小分子
產品
(產品類型)
靶點
適應症
權益區域
ASC30
(每日一次口服
小分子激動劑)
GLP-1R
肥胖症
全球
ASC30
(每日一次口服
小分子激動劑)
GLP-1R
糖尿病
全球
ASC39
(每日一次口服
小分子激動劑)
胰淀素受體SARA
肥胖症
全球
ASC30_39FDC
(每日一次口服
小分子雙靶點激動劑)
GLP-1R/
胰淀素受體SARA
肥胖症
全球
ASC30_48FDC
(每日一次口服
小分子雙靶點激動劑)
GLP-1R/GIPR
肥胖症
全球
ASC30_48_39FDC
(每日一次口服
小分子三靶點激動劑)
GLP-1R/GIPR/
胰淀素受體SARA
肥胖症
全球
Discovery
IND Enabling
I期
II期
Ⅲ期
Discovery
IND Enabling
I期
II期
III期
Discovery
IND Enabling
I期
II期
III期
III期
NDA
代謝性疾病管線 - 多肽
產品
(產品類型)
靶點
適應症
權益區域
ASC36i
(每月一次至每季度一次
皮下注射激動劑多肽)
胰淀素受體
肥胖症
全球
ASC36o
(口服激動劑多肽)
胰淀素受體
肥胖症
全球
ASC35
(每月一次皮下
注射激動劑多肽)
GLP-1R/GIPR
肥胖症
全球
ASC36_35FDC
(每月一次皮下注射
三靶點激動劑多肽)
胰淀素受體+
GLP-1R/GIPR
肥胖症
全球
ASC37i
(每月一次皮下注射
三靶點激動劑多肽)
GLP-1R/GIPR/GCGR
肥胖症
全球
ASC37o
(口服激動劑多肽)
GLP-1R/GIPR/GCGR
肥胖症
全球
ASC36_37FDC
(每月一次皮下注射
四靶點激動劑多肽)
胰淀素受體+
GLP-1R/GIPR/GCGR
肥胖症
全球
免疫性疾病管線
產品
(產品類型)
靶點
適應症
權益區域
ASC50
(每日一次口服
小分子抑制劑)
IL-17A
銀屑病及
其他免疫性疾病
全球
ASC51
(每日一次口服
小分子降解劑)
STAT6
免疫性疾病
全球
ASC52
(每日一次口服環肽抑制劑)
IL-17A和F
免疫性疾病
全球
拓展性適應症管線
產品
(產品類型)
靶點
適應症
權益區域
ASC40
(口服小分子)
脂肪酸合成酶
(FASN)
痤瘡
大中華區1
Discovery
IND Enabling
I期
II期
附註: 1.本集團已從Sagimet獲得地尼法司他(ASC40)的大中華區獨家授權。
縮寫: GLP-1R:胰高血糖素樣肽-1受體;SARA:選擇性胰淀素受體激動劑;FDC:固定劑量複方製劑;GIPR:
葡萄糖依賴性促胰島素多肽受體;GCGR:胰高血糖素受體;STAT6:信號轉導和轉錄激活因子6;IL-17A
和F:白細胞介素-17A和F;FASN:脂肪酸合成酶。
5
管理層討論與分析
業務回顧
於報告期內及直至本公告日期,本集團已就其業務取得以下進展。
代謝性疾病
小分子
治療肥胖症的ASC30每日一次口服片
於報告期內及直至本公告日期,本集團已獲得FDA的III期臨床研究批准,並已針
對ASC30長期體重管理適應症啟動了一項全球III期臨床項目,該項目由兩項關鍵
的多中心、隨機、雙盲、安慰劑對照的全球III期試驗(AURORA-1, NCT07743463
和AURORA-2, NCT07743450)組成,將在美國、歐洲和加拿大共入組約4,600名
肥胖或超重受試者。近期,ASC30用於長期體重管理的全球III期臨床項目已完成
首例受試者給藥。
這兩項關鍵研究將評估每日一次口服三種維持劑量(20毫克、40毫克和60毫克)的
ASC30對比安慰劑,在不伴有2型糖尿病的肥胖或超重受試者(AURORA-1)以及伴
有2型糖尿病的肥胖或超重受試者(AURORA-2)中的長期療效、安全性和耐受性。
AURORA-1和AURORA-2的治療週期均為72週。
本公司預計將於二零二八年第三季度公佈ASC30 III期臨床項目的頂線數據,並計
劃於二零二八年底向FDA提交NDA以及於二零二九年初向EMA遞交MAA。如獲
得美國和歐洲相關監管機構的批准,ASC30將有望成為繼orforglipron後,在美國
和歐洲獲批的第二款口服小分子GLP-1。
預計二零二六年里程碑: 由於ASC30用於長期體重管理的全球III期臨床項目已完
成首例受試者給藥,本集團已完成二零二六年里程碑。
治療糖尿病的ASC30每日一次口服片
於報告期內及直至本公告日期,本集團已完成其評估口服小分子GLP-1R激動劑
ASC30治療2型糖尿病的為期13週的美國II期研究(NCT07321678)入組。2型糖尿
病是ASC30繼肥胖症(其首個適應症)之後的第二個適應症。
預計二零二六年里程碑: 預計將於二零二六年第三季度公佈ASC30每日一次口服
片治療糖尿病的為期13週的美國II期研究的頂線數據。
6
治療肥胖症的ASC39每日一次口服片
於報告期內及直至本公告日期,本集團已選定 ASC39(一款潛在同類首創、與
eloralintide類似的每日一次口服小分子胰淀素選擇性受體激動劑(SARA))作為臨
床開發候選藥物。
在與eloralintide的頭對頭cAMP激活實驗中,口服小分子胰淀素受體激動劑ASC39
顯示出與eloralintide相似的選擇性與活性。ASC39 與eloralintide對hAMY1R的
EC50 分別為21.4 pM和21.2 pM。ASC39與eloralintide對hCTR的EC50 分別為846.1
pM 和 1,350.8 pM。這些數據表明,相較於 hCTR,ASC39 與 eloralintide 都對
hAMY1R更具有選擇性,且選擇性相當。
在與eloralintide的頭對頭DIO大鼠研究中,ASC39的口服給藥療效與eloralintide的
相當,顯示出顯著的、經安慰劑校正後的體重下降,ASC39為6.6%,eloralintide
為5.6%。
預計二零二六年里程碑: 預計將於二零二六年第三季度向FDA遞交ASC39口服片
治療肥胖症的IND申請。
治療肥胖症的ASC30_39FDC每日一次口服片
於報告期內及直至本公告日期,本集團已選定 ASC30_39FDC 進行臨床開發,
ASC30_39FDC為ASC30(一款每日一次口服小分子GLP-1R激動劑)與ASC39(一
款潛在同類首創、與eloralintide類似的每日一次口服小分子SARA)的固定劑量複
方製劑。
在一項頭對頭研究中,ASC30_39FDC片在犬中口服給藥後,其藥代動力學表現與
在各自單藥療法中觀察到的表現相當。該固定劑量複方製劑表現出良好的口服生
物利用度、藥物暴露量以及長達12小時的半衰期。這些數據支持ASC30_39FDC
片有望成為每日一片的新型肥胖症療法。
ASC30_39FDC顯示出ASC30與ASC39聯合製備時具有良好的兼容性,以及室溫
穩定性和小片劑規格的特點。
預計二零二六年里程碑: 預計將於二零二六年第三季度向FDA遞交ASC30_39FDC
口服片治療肥胖症的IND申請。
治療肥胖症的ASC30_48FDC每日一次口服片
於報告期內及直至本公告日期,本集團已選定ASC48(一款潛在同類首創口服小
分子GIPR激動劑)與ASC30(一款口服小分子GLP-1R激動劑)的固定劑量複方製
劑進行臨床開發。ASC30_48FDC同時靶向GLP-1R及GIPR,有望成為同類首創、
每日一次、每次一片的口服肥胖症療法。
在hGIPR cAMP激活實驗中,ASC48的EC50 為1 pM,展現出比替爾泊肽(EC50 = 3
pM)更強的激動活性,且為GIPR的選擇性激動劑,對GLP-1R和GCGR無激動活
性。
7
在嚙齒類動物和非人靈長類動物中,ASC48展現出了極佳的口服生物利用度、藥
物暴露量和較長的半衰期,支持在人體中每日一次口服給藥。
在頭對頭非人靈長類動物研究中,ASC30_48FDC的減重效果較ASC30單藥相對
提升約52%。
預計二零二六年里程碑: 預計將於二零二六年第四季度向FDA遞交ASC30_48FDC
口服片治療肥胖症的IND申請。
治療肥胖症的ASC30_48_39FDC每日一次口服片
於報告期內及直至本公告日期,本集團已公佈其潛在同類首創、每日一次口服小
分子GLP-1/GIP╱ 胰淀素三靶點激動劑固定劑量複方製劑的積極數據。其顯示出
對GIPR激動劑(ASC48)的劑量依賴性,經七日治療後,在非人靈長類動物中,據
統計,顯著減重高達15.2%。這表明相較於靶向GLP-1R及胰淀素受體(SARA)的
口服雙靶點激動劑固定劑量複方製劑(ASC30_39FDC),減重效果相對提升高達
120%。該項數據表明GIP成分(ASC48)對ASC30_48_39FDC三靶點激動劑至關重
要。
預計二零二六年里程碑: 預計將於二零二六年第四季度向FDA遞交ASC30_48_39FDC
口服片治療肥胖症的IND申請。
多肽
治療肥胖症的ASC36每月一次至每季度一次皮下注射多肽
於報告期內及直至本公告日期,本集團已獲得FDA對ASC36(一款每月一次至每
季度一次的新一代胰淀素受體激動劑多肽)的IND批准,並已啟動其I期研究。
ASC36每月一次至每季度一次製劑為SALD製劑,由歌禮利用其超長效藥物開發
平台(ULAP)技術自主開發。
在頭對頭非人靈長類動物研究中,ASC36 SALD製劑的表觀半衰期約為eloralintide
的6倍,支持在人體中每月一次至每季度一次皮下給藥。
在頭對頭DIO大鼠研究中,ASC36單藥較petrelintide單藥和eloralintide單藥的減重
效果分別相對提升約91%和32%。
預計二零二六年里程碑: 預計將於二零二六年末前公佈ASC36每月一次至每季度
一次皮下注射多肽的頂線藥代動力學數據。
治療肥胖症的ASC36口服多肽
於報告期內及直至本公告日期,本集團已向FDA遞交ASC36口服片的IND申請。
8
在非人靈長類動物研究中,通過利用歌禮口服多肽遞送增強技術(POTENT),ASC36
口服片在穩定狀態下的絕對口服生物利用度達6%至8%。
在非人靈長類動物中,ASC36 口服片每日一次給藥7 天後,使相對基線的平均體
重下降高達13.2%。ASC36片亦顯著減少了食物攝入。
憑藉潛在更優的口服生物利用度和療效,預計ASC36口服片的給藥劑量更低。每
毫克ASC36多肽更優越的減重效果,也可能使其在規模化生產中成本更低。
預計二零二六年里程碑: 預計將於二零二六年第三季度啟動ASC36口服多肽治療
肥胖症的I期試驗。
治療肥胖症的ASC35每月一次皮下注射多肽
於報告期內及直至本公告日期,本集團已獲得 FDA 對治療肥胖症的 ASC35(一
款潛在同類最佳、每月一次皮下注射GLP-1R/GIPR雙靶點激動劑多肽)的IND批
准,並已啟動其I期研究。
ASC35每月一次製劑為SALD製劑,由歌禮利用其超長效藥物開發平台(ULAP)技
術自主開發。在頭對頭非人靈長類動物研究中,ASC35的平均表觀半衰期約比替
爾泊肽長6倍,支持在人體中每月一次皮下給藥。
在頭對頭DIO小鼠研究中,ASC35的減重效果較替爾泊肽相對提升約71%。
預計二零二六年里程碑: 預計將於二零二六年末前公佈ASC35每月一次皮下注射
多肽的頂線藥代動力學數據。
治療肥胖症的ASC36_35FDC每月一次皮下注射多肽
於報告期內及直至本公告日期,本集團已獲得FDA對ASC36_35FDC(一款ASC36
與ASC35的皮下固定劑量複方月注射劑)IND批准,並已啟動其I期研究。
ASC36_35FDC每月一次製劑為SALD製劑,由歌禮利用其超長效藥物開發平台
(ULAP)技術自主開發。
在非人靈長類動物研究中,ASC36和ASC35兩者在ASC36_35FDC SALD複方製
劑中均具有較長的表觀半衰期,支持在人體中每月一次皮下給藥。
在頭對頭DIO大鼠研究中,ASC36_35FDC靶向胰淀素受體、GLP-1R及GIPR三個
靶點,減重效果較eloralintide聯合替爾泊肽相對提升約51%。
預計二零二七年里程碑: 預計將於二零二七年第一季度初公佈ASC36_35FDC每月
一次皮下注射多肽的頂線藥代動力學數據。
9
治療肥胖症的ASC37每月一次皮下注射多肽
於報告期內及直至本公告日期,本集團已選定新一代每月一次皮下給藥的GLP1R/GIPR/GCGR三靶點激動劑多肽ASC37注射劑作為臨床開發候選藥物。
經精準定向設計,ASC37包含41個α-氨基酸,符合生物製品資格。ASC37每月一
次皮下製劑的生物製品許可申請(BLA)將在III期研究完成後向FDA遞交。
ASC37皮下SALD製劑的平均表觀半衰期約為17天,而retatrutide為2.5天。ASC37
這一約7倍長於retatrutide的半衰期,支持每月一次或更低的給藥頻率。
在DIO小鼠模型中,ASC37的減重效果較替爾泊肽相對提升88%,且差異具有統
計學顯著性。
預計二零二六年里程碑: 預計將於二零二六年第三季度向FDA遞交ASC37注射劑
治療肥胖症的IND申請。
治療肥胖症的ASC37口服多肽
於報告期內及直至本公告日期,本集團持續開發ASC37口服片。
預計二零二六年里程碑: 預計將於二零二六年第三季度向FDA遞交ASC37口服片
治療肥胖症的IND申請。
治療肥胖症的ASC36_37FDC每月一次皮下注射多肽
於報告期內及直至本公告日期,本集團已選定GLP-1/GIP/GCG╱ 胰淀素四靶點激
動劑、ASC36與ASC37的皮下固定劑量複方月注射劑ASC36_37FDC。
預計二零二六年里程碑: 預計將於二零二六年第三季度向FDA遞交ASC36_37FDC
注射劑治療肥胖症的IND申請。
儘管於報告期內及直至本公告日期本集團在免疫性疾病管線方面取得重大進展,
但其已作出戰略決策,重點關注其代謝性疾病管線,並尋求ASC50、ASC51 及
ASC52對外授權的機會。該策略將令本集團將其全部資源集中於其代謝性疾病管
線,並擁有充足的在手現金支持其運營至二零二九年。
於報告期內及直至本公告日期,本集團在地尼法司他(ASC40)治療中重度痤瘡適
應症的NDA方面與國家藥監局展開積極溝通。本集團持續與國家藥監局對接,以
期令地尼法司他(ASC40)惠及患者。本集團已從Sagimet獲得地尼法司他(ASC40)
的大中華區獨家授權。
10
臨床前發現
基於其三個核心探索引擎:(i)基於結構的AI輔助藥物發現(AISBDD)平台;(ii)超
長效藥物開發平台(ULAP);及(iii)口服多肽遞送增強技術(POTENT),本集團繼
續加強探索,以開發更多具有全球同類最佳和同類首創競爭力的小分子及多肽管
線產品。
上市規則第18A.05及18A.08(3)條規定的警示聲明:我們無法保證我們將能夠最終
令管線中的候選藥物成功開發、銷售及 ╱ 或商業化。
本集團的設施
本集團在浙江省紹興市有總建築面積約為17,000平方米的製造廠。該廠配備先進
的生產設備,具有尖端技術能力,例如熱熔擠出機及高速壓片機,以確保我們產
品的高質量。
於二零二六年六月三十日,本集團擁有10家全資附屬公司。本集團大部分業務通
過在香港的歌禮製藥(中國)開展,而本集團小部分業務通過在中國內地的歌禮生
物科技及歌禮藥業開展。
未來及前景
本集團已建立擁有關鍵臨床階段資產的全面代謝性疾病管線。以下為二零二六年
下半年的策略及展望:
1.
預計將於二零二六年第三季度公佈每日一次ASC30片治療糖尿病的為期13週
的美國II期研究的頂線數據;
2.
預計將於二零二六年第三季度向FDA遞交ASC39口服片治療肥胖症的IND申
請;
3.
預計將於二零二六年第三季度向FDA遞交ASC30_39FDC口服片治療肥胖症
的IND申請;
4.
預計將於二零二六年第四季度向FDA遞交ASC30_48FDC口服片治療肥胖症
的IND申請;
5.
預計將於二零二六年第四季度向FDA遞交ASC30_48_39FDC口服片治療肥胖
症的IND申請;
6.
預計將於二零二六年末前公佈ASC36每月一次至每季度一次皮下注射多肽的
頂線藥代動力學數據;
11
7.
預計將於二零二六年第三季度啟動ASC36口服多肽治療肥胖症的I期試驗;
8.
預計將於二零二六年末前公佈ASC35每月一次皮下注射多肽的頂線藥代動力
學數據;
9.
預計將於二零二六年第三季度向FDA遞交ASC37注射劑治療肥胖症的IND申
請;
10. 預計將於二零二六年第三季度向FDA遞交ASC37口服片治療肥胖症的IND申
請;
11. 預計將於二零二六年第三季度向FDA遞交ASC36_37FDC注射劑治療肥胖症
的IND申請;
12. 持續加強早期研發工作,開發更多具全球同類最佳及同類首創競爭力的管線
資產;
13. 與全球大型製藥企業尋求對外授權合作機會,以實現本集團價值最大化;及
14. 本集團擁有充足的在手現金,除覆蓋預計向FDA提交的NDA及向EMA提交
的MAA外,可支持其運營至二零二九年。
財務回顧
收入總額
本集團收入總額為收入、其他收入及收益,由截至二零二五年六月三十日止六個
月的約人民幣103.6百萬元減少至截至二零二六年六月三十日止六個月的約人民幣
53.0百萬元,主要由於一次性非經常性收入(主要來自中國內地實體的政府補助)
減少。
其他收入及收益
本集團其他收入及收益由截至二零二五年六月三十日止六個月的約人民幣102.5百
萬元減少48.3%至截至二零二六年六月三十日止六個月的約人民幣53.0 百萬元,
主要由於(i)中國內地實體的政府補助由截至二零二五年六月三十日止六個月的約
人民幣34.2百萬元減少至截至二零二六年六月三十日止六個月的約人民幣1.2百萬
元;(ii)權益投資的已變現及未變現收益淨額由截至二零二五年六月三十日止六
個月的約人民幣37.7百萬元減至截至二零二六年六月三十日止六個月的約人民幣
17.3百萬元。該減少主要歸因於按公平值計入損益計量的本集團於Sagimet的投資
的公平值收益減少,原因為Sagimet股價於報告期內的升值幅度低於二零二五年同
期;及(iii)匯兌虧損由截至二零二五年六月三十日止六個月的約人民幣1.3百萬元
大幅增加至截至二零二六年六月三十日止六個月的約人民幣10.1百萬元,被銀行
利息收入由截至二零二五年六月三十日止六個月的約人民幣30.0百萬元大幅增至
截至二零二六年六月三十日止六個月的人民幣39.5百萬元所抵銷。
12
下表載列於所示期間其他收入及收益的組成部分:
未經審核
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
銀行利息收入
權益投資產生已變現及未變現收益淨額
理財產品及結構性存款產生已變現及未變現
收益淨額
按公平值計入其他全面收入的金融資產的已變
現及未變現收益淨額
政府補助
匯兌虧損淨額
其他
總計
39,466
17,336
30,037
37,679
3,643
1,472
709
1,188
(10,110)
747
431
34,175
(1,308)
10
52,979
102,496
行政開支
本集團的行政開支由截至二零二五年六月三十日止六個月的約人民幣43.3百萬元
減少28.9%至截至二零二六年六月三十日止六個月的約人民幣30.8百萬元,主要是
由於員工相關成本減少。
我們的行政開支主要包括(i)非研發人員的員工薪金及福利成本;(ii)代理及諮詢
費;及(iii)公用能耗、租金及一般辦公室開支。
下表載列於所示期間我們行政開支的組成部分:
未經審核
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
%
員工薪金及福利
代理及諮詢費
公用能耗、租金及
一般辦公室開支
其他
12,612
13,959
40.9
45.3
20,517
17,548
47.4
40.5
4,092
140
13.3
0.5
4,897
340
11.3
0.8
總計
30,803
100.0
43,302
100.0
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研發開支
本集團的研發開支主要包括臨床前及臨床試驗開支、員工成本以及折舊及攤銷成
本。
本集團的研發開支由截至二零二五年六月三十日止六個月的約人民幣146.8百萬元
增加132.7%至截至二零二六年六月三十日止六個月的約人民幣341.7百萬元,主
要由於本集團已增加對代謝性疾病產品管線的投資。
本集團增加對代謝性疾病產品管線的投資,乃配合該領域所取得的重大進展。
儘管研發開支大幅增加,惟於二零二六年六月三十日,本集團擁有現金及現金等
價物、定期存款、可轉讓存單、結構性存款及理財產品約人民幣2,305.4 百萬元
(二零二五年六月三十日:約人民幣1,827.9 百萬元),可支持其運營至二零二九
年。
下表載列於所示期間研發成本的組成部分:
未經審核
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
臨床前及臨床試驗開支
員工成本
折舊及攤銷成本
其他
268,394
55,812
7,657
9,800
75,897
60,796
5,553
4,566
總計
341,663
146,812
下表載列於所示期間按產品管線劃分的研發成本組成部分:
未經審核
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
代謝性疾病
拓展性適應症
臨床前
145,777
14,506
181,380
42,640
66,149
38,023
總計
341,663
146,812
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融資成本
由於租賃負債的利息的影響,本集團於截至二零二六年六月三十日止六個月錄得
融資成本約人民幣0.1百萬元(二零二五年六月三十日:約人民幣0.1百萬元)。
所得稅
本集團須按實體基準就產生自或源自本集團成員公司註冊及營運所在司法權區的
溢利繳納所得稅。
本集團使用適用於預期年度盈利總額之稅率計算所得稅開支。
本集團於截至二零二六年六月三十日止六個月錄得所得稅約人民幣0.1百萬元(二
零二五年六月三十日:無)。
存貨
本集團的存貨包括研發所用的原材料。我們的存貨由二零二五年十二月三十一日
的約人民幣1.9百萬元減少37.6%至二零二六年六月三十日的約人民幣1.2百萬元,
主要是由於加強存貨管理。
下表載列截至所示日期的存貨結餘:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
原材料
1,169
1,874
總計
1,169
1,874
貿易應收款項
本集團的貿易應收款項由二零二五年十二月三十一日的約人民幣0.2百萬元減少至
二零二六年六月三十日的零。
下表載列截至所示日期的貿易應收款項結餘:
15
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
貿易應收款項
–
223
總計
–
223
本集團與客戶之交易條款主要為授出信貸期。信貸期通常為30日至90日。本集團
力求就其尚未收取應收款項維繫嚴格的控制及逾期結餘由高級管理層定期審閱。
貿易應收款項為不計息。
於所示日期之貿易應收款項基於發票日期並扣除虧損撥備之賬齡分析如下:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
三個月內
–
223
–
223
預付款項、其他應收款項及其他資產
下表載列於所示日期的預付款項、其他應收款項及其他資產的組成部分:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
可抵扣增值稅
按金及其他應收款項
預付款項
預付開支
17,362
4,122
3,478
1,250
9,940
3,056
3,544
1,207
總計
26,212
17,747
16
我們的可抵扣增值稅指可結轉用以抵銷未來銷項增值稅(「增值稅」),或由相關稅
務機關退還的增值稅。我們的可抵扣增值稅由二零二五年十二月三十一日的約人
民幣9.9百萬元增加74.7%至二零二六年六月三十日的約人民幣17.4百萬元,主要
由於報告期內研發開支增加引致的增值稅進項稅額增加。
按金及其他應收款項為雜項開支,包括租金及其他按金。
我們的預付款項主要與購買臨床試驗服務有關,截至二零二六年六月三十日止六
個月約為人民幣3.5百萬元(二零二五年六月三十日:約人民幣3.5百萬元)。
於二零二六年六月三十日,向供應商作出之預付款項於一年內到期。
於二零二六年六月三十日,本集團並無就預付款項、其他應收款項及其他資產計
提減值虧損。
按公平值計入損益的金融資產 - 非流動
本集團按公平值計入損益的金融資產非流動部分(主要由本集團於Sagimet納斯達
克上市股票的投資組成)由二零二五年十二月三十一日的人民幣56.4百萬元增加至
二零二六年六月三十日的約人民幣68.7百萬元,主要是由於期內Sagimet的股份報
價有所提升。
按公平值計入損益的金融資產 - 流動
本集團按公平值計入損益的金融資產流動部分由二零二五年十二月三十一日的約
人民幣26.1百萬元減少至二零二六年六月三十日的約人民幣24.9百萬元,主要是
由於減少對理財產品的投資。
現金及銀行結餘
下表載列於所示日期本集團的定期存款以及現金及現金等價物的組成部分:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
定期存款
現金及現金等價物
1,616,939
593,371
431,259
1,443,513
總計
2,210,310
1,874,772
17
原到期日超過三個月的定期存款乃根據我們的即時現金需求按不同期限作出,並
按各項定期存款的利率賺取利息。現金及現金等價物以及定期存款根據每日銀行
存款利率及相關定期存款利率按浮動利率計息。現金及現金等價物及定期存款存
放於信譽度高且無近期違約歷史的銀行。
貿易應付款項
本集團的貿易應付款項主要包括支付予原材料供應商的款項。下表載列我們於所
示日期的貿易應付款項的組成部分:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
貿易應付款項
14,623
1,344
總計
14,623
1,344
下表載列於所示日期的貿易應付款項基於發票日期之賬齡分析:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
少於三個月
14,623
1,344
其他應付款項及應計費用
下表載列於所示日期的其他應付款項及尚未支付的應計費用之組成部分:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
應計開支
其他應付款項
應付工資
撥備
除所得稅外之稅項
101,785
36,569
16,577
4,038
217
69,375
30,630
17,217
4,038
529
總計
159,186
121,789
18
於二零二六年六月三十日的應計開支主要為實際已產生但尚未開具發票的應計研
發開支。應計開支由二零二五年十二月三十一日的約人民幣69.4百萬元增加至二
零二六年六月三十日的約人民幣101.8百萬元。應計開支不計息且於一年內到期。
我們的其他應付款項保持相對穩定,由二零二五年十二月三十一日的約人民幣
30.6百萬元增加至二零二六年六月三十日的約人民幣36.6百萬元。
應付工資為二零二六年上半年的應計工資及獎金,且於一年內到期。應付工資由
二零二五年十二月三十一日的約人民幣17.2百萬元減少至二零二六年六月三十日
的約人民幣16.6百萬元,主要由於應計工資及獎金減少。
於二零二五年十二月三十一日及二零二六年六月三十日,撥備均保持不變,為約
人民幣4.0百萬元。
遞延收入
本集團的遞延收入指本集團的中國內地附屬公司已收取以補償相關實體資產成本
的政府補助的未攤銷部分,該款項其後於相關資產的可使用年期內在損益確認為
收入。下表載列截至所示日期的遞延收入:
於二零二六年
六月三十日
於二零二五年
十二月三十一日
(未經審核)
人民幣千元
(經審核)
人民幣千元
政府補助
- 即期
- 非即期
1,588
1,588
1,588
2,382
總計
3,176
3,970
流動資金及資本資源
本集團現金的主要用途是為研發活動、購買設備及原材料以及其他經常性支出提
供資金。於報告期內,本集團以全球發售、補足配售及根據一般授權進行的配售
的所得款項為營運資金及其他資本開支需求提供資金。
19
下表載列本集團於所示期間的簡明綜合現金流量表概要及於所示期間的現金及現
金等價物結餘分析:
經營活動所用現金淨額
投資活動(所用)╱ 所得現金淨額
融資活動所得 ╱(所用)現金淨額
現金及現金等價物(減少)╱ 增加淨額
期初現金及現金等價物
外匯匯率變動的影響淨額
期末現金及現金等價物
截至
二零二六年
六月三十日
止六個月
(未經審核)
人民幣千元
截至
二零二五年
六月三十日
止六個月
(未經審核)
人民幣千元
(327,349)
(1,192,401)
708,762
(810,988)
1,443,513
(39,154)
(172,990)
904,605
(14,485)
717,130
864,326
(1,116)
593,371
1,580,340
於二零二六年六月三十日,現金及現金等價物主要以人民幣及美元計值。
經營活動
我們經營活動的現金流入主要包括已收客戶的貿易應收款項及政府補助,截至目
前,本集團收到的政府補助全部來自中國內地實體及澳洲實體,並未從香港實體
收到過該等補助。我們經營活動的現金流出主要包括研發成本及行政開支付款。
截至二零二六年六月三十日止六個月,我們的經營活動所用現金淨額約為人民幣
327.3百萬元,乃主要由於營運資金變動前的經營虧損約為人民幣358.3百萬元。
營運資金的變動乃主要由於支付研發成本。
投資活動
我們的投資活動所用現金主要包括購買原到期日為三個月以上的定期存款、購買
物業、廠房及設備、購買無形資產及購買按公平值計入損益的金融資產。
20
截至二零二六年六月三十日止六個月,我們的投資活動所用現金淨額約為人民
幣1,192.4 百萬元,乃主要由於原到期日為三個月以上的定期存款增加約人民幣
1,194.1百萬元。
融資活動
我們的融資活動所得現金主要與根據一般授權配售新股的所得款項有關。
截至二零二六年六月三十日止六個月,我們的融資活動所得現金淨額約為人民幣
708.8百萬元,主要由於根據一般授權配售新股的所得款項約人民幣742.3百萬元。
資本開支
本集團的主要資本開支主要包括購買辦公設備以及廠房及機器。下表載列我們於
所示日期的資本開支淨額:
二零二六年
二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
辦公設備
廠房及機器
9
1,224
872
468
總計
1,233
1,340
我們的資本開支由二零二五年十二月三十一日的約人民幣1.3百萬元減少8.0%至二
零二六年六月三十日的約人民幣1.2百萬元,乃主要由於我們減少購買實驗室裝修
所需的辦公設備。
所持重大投資、重大收購及出售
除本公告披露者外,截至二零二六年六月三十日止六個月,本集團並無任何根據
上市規則附錄D2第32(4A)段須予披露的重大投資,亦無對附屬公司及聯營公司進
行任何重大收購或出售。
債項
借款、資產抵押及擔保
於二零二六年六月三十日,本集團並無任何未清償的按揭、押記、債券、其他已
發行債務資本、銀行透支、借款、承兌負債或其他類似債務、任何擔保或其他重
大或然負債。
21
或然負債
(a) Viking案
於二零二二年十二月二十九日,Viking Therapeutics, Inc.(「Viking」,一家位
於美國的製藥公司)就本集團的候選藥物ASC41及ASC43F向本公司、其創始
人吳勁梓及本公司若干附屬公司作出若干控告。一項控告向位於華盛頓特區
的美國國際貿易委員會(「ITC」)提出,另一項控告則向美國加利福尼亞州南
區地方法院(「USDC」)聖迭戈分院提出,各項控告所列指控相似。
於二零二四年十月四日及二零二五年五月二十九日,本公司收到ITC對該控
告的初步裁定及最終判決(統稱「判決」)。ITC行政法官作出的判決認定本公
司候選藥物ASC41 和ASC43F進口至美國違反《1930 年關稅法案》
(修訂版)
第337條。此外,由於調查階段的若干程序問題,判決提出處以567,000美元
(相當於約人民幣4,038,000元)的罰款。本公司已在財務報表中為該項罰款計
提撥備。
就向USDC提出的控告而言,自二零二六年一月一日以來未有重大進展,相
關調查和訴訟程序正在進行中。本公司將就控告積極進行抗辯。因此,於二
零二六年六月三十日,本集團尚未對Viking向USDC提交的控告所引起的指
控作出任何撥備。
(b) 仲裁案
於二零二五年九月,歌禮藥業捲入一宗由先前客戶發起的仲裁程序,該程序
主要源於有關若干產品銷售的商業合約糾紛。
申訴人要求賠償總額約人民幣25百萬元,其中包括(i)合約付款,(ii)涉嫌佔用
資金的利息,及(iii)仲裁和法律費用。
於本公告日期,仲裁仍在進行中,尚未作出裁決。根據目前可獲得的信息,
無法可靠地估計仲裁結果及其對本集團的潛在財務影響。於二零二六年六月
三十日,本集團概無就該仲裁作出任何撥備。
資產抵押
於二零二六年六月三十日,本集團並無資產抵押。
22
合約承擔
我們根據經營租賃安排租賃部分物業及倉庫。磋商的物業及倉庫租期主要介於一
至三年。
於二零二六年六月三十日,本集團的資本承擔約為人民幣3.2百萬元,而於二零二
五年十二月三十一日,資本承擔約為人民幣0.6百萬元。
主要財務比率
下表載列截至所示日期的主要財務比率:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
流動比率 (1)
速動比率 (2)
資產負債比率 (3)
12.9
12.9
7.4%
15.1
15.0
6.4%
附註:
(1)
流動比率指流動資產除以截至同日的流動負債。
(2)
速動比率指流動資產減存貨後除以截至同日的流動負債。
(3)
資產負債比率指負債總額除以截至同日的資產總值再乘以100%。
我們的流動比率由二零二五年十二月三十一日的15.1減少至二零二六年六月三十
日的12.9,而我們的速動比率由二零二五年十二月三十一日的15.0減少至二零二
六年六月三十日的12.9,主要是由於流動負債增加所致。
我們的資產負債比率由二零二五年十二月三十一日的6.4%增加至二零二六年六月
三十日的7.4%,主要由於流動負債增加。
外匯風險
外匯風險指外匯匯率變動造成損失的風險。人民幣與本集團開展業務所涉及的其
他貨幣之間的匯率波動或會影響我們的財務狀況及經營業績。
本集團主要於中國經營業務,並面臨來自多種貨幣風險的外匯風險(主要為美
元)。外匯風險來自海外業務的已確認資產及負債。將外幣(包括美元)兌換為人
民幣以中國人民銀行設定的匯率換算。本集團尋求透過密切監控及最小化外匯淨
頭寸來限制其面臨的外匯風險。於報告期內,本集團並無訂立任何貨幣對沖交易。
23
僱員及薪酬政策
本集團董事及高級管理層的薪酬乃由董事會參考薪酬委員會的建議,並考慮本集
團的經營業績、同類公司支付的薪酬、董事及高級管理層須付出的時間及其職責
以及聘任條件後釐定。
於二零二六年六月三十日,本集團共有217 名僱員,其中大多數僱員位於中國。
超過79.7%的僱員持有學士或更高學位。下表載列本集團所披露的按職能劃分的
僱員情況:
於二零二六年六月三十日
員工人數
佔總數%
管理
研發
製造
營運
3
149
32
33
1.4
68.7
14.7
15.2
總計
217
100.0
截至二零二六年六月三十日止六個月,本集團的總員工成本約為人民幣68.4百萬
元,而截至二零二五年六月三十日止六個月約為人民幣82.1百萬元。
本集團透過招聘網站、招聘人員、內部推介和招聘會來招聘員工。本集團為員工
提供新員工培訓以及專業與合規培訓課程。
本集團與員工訂立聘用合約,以涵蓋工資、福利及終止依據等事宜。我們員工的
薪酬待遇包括工資和獎金,一般參考資歷、行業經驗、職位和表現決定。本集團
按照中國法律法規的要求為其員工繳納社會保險和住房公積金。
本集團亦已採納上市規則第十七章所載股份計劃,以獎勵為實現本集團長期發展
而作出持續貢獻的僱員。
24
綜合損益表
截至二零二六年六月三十日止六個月 - 未經審核
二零二六年
人民幣千元
二零二五年
人民幣千元
–
–
1,081
(960)
–
121
52,979
(341,663)
(30,803)
(12)
102,496
(146,812)
(43,302)
(367)
經營虧損
(319,499)
(87,864)
融資成本
(74)
(87)
附註
收益
銷售成本
3
毛利
其他收入及收益
研發成本
行政開支
其他開支
4
除稅前虧損
5
(319,573)
(87,951)
所得稅
6
(98)
–
期內虧損
(319,671)
(87,951)
以下人士應佔:
本公司權益股東
(319,671)
(87,951)
人民幣
(30.74)分
人民幣
(9.14)分
每股虧損
基本及攤薄
7
25
綜合損益及其他全面收入表
截至二零二六年六月三十日止六個月 - 未經審核
二零二六年
人民幣千元
二零二五年
人民幣千元
(319,671)
(87,951)
於往後重新分類或可能重新分類至損益之項目:
換算海外業務產生之匯兌差異
7,850
247
將不會重新分類至損益之項目:
換算為本公司財務報表呈列貨幣之匯兌差異
(65,026)
(5,546)
期內其他全面收入
(57,176)
(5,299)
期內全面虧損總額
(376,847)
(93,250)
以下人士應佔:
本公司權益股東
(376,847)
(93,250)
期內虧損
期內其他全面收入(經扣除稅項)
26
綜合財務狀況表
於二零二六年六月三十日 - 未經審核
附註
非流動資產
物業、廠房及設備
就物業、廠房及設備的預付款項
使用權資產
其他無形資產
按公平值計入其他全面收入(「按公平值
計入其他全面收入」)的金融資產
按公平值計入損益(「按公平值計入
損益」)的金融資產
長期遞延開支
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
35,362
177
4,926
9,383
39,625
259
7,077
10,285
38,007
31,733
68,687
376
56,367
460
156,918
145,806
1,169
–
24,897
26,212
32,164
593,371
1,616,939
1,874
223
26,103
17,747
–
1,443,513
431,259
2,294,752
1,920,719
14,623
159,186
2,240
1,588
1,344
121,789
2,871
1,588
177,637
127,592
流動資產淨值
2,117,115
1,793,127
總資產減流動負債
2,274,033
1,938,933
8
9
流動資產
存貨
貿易應收款項
按公平值計入損益的金融資產
預付款項、其他應收款項及其他資產
按公平值計入其他全面收入的金融資產
現金及現金等價物
原到期日為三個月以上的定期存款
10
流動負債
貿易應付款項
其他應付款項及應計費用
租賃負債
遞延收入
11
27
綜合財務狀況表(續)
於二零二六年六月三十日 - 未經審核
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
非流動負債
租賃負債
遞延收入
1,496
1,588
2,287
2,382
3,084
4,669
資產淨值
2,270,949
1,934,264
資本及儲備
股本
儲備
727
2,270,222
679
1,933,585
本公司權益股東應佔權益總額
2,270,949
1,934,264
權益總額
2,270,949
1,934,264
28
未經審核中期財務報告附註
1.
公司資料
本公司為一家於二零一四年二月二十五日在開曼群島註冊成立的有限公司。本公司的註冊
辦事處位於190 Elgin Avenue, George Town, Grand Cayman KY1-9008, Cayman Islands。
本公司的香港主要營業地點地址為香港灣仔皇后大道東248號大新金融中心40樓。
本公司為一間投資控股公司。本公司的附屬公司主要從事藥品研發。
本公司股份於二零一八年八月一日於香港聯合交易所有限公司(「聯交所」)主板上市。
2.
編製基準及會計政策及披露事項變動
2.1
編製基準
本中期財務報告根據香港聯合交易所有限公司證券上市規則中適用的披露條款編製,包括
遵守香港會計師公會(「香港會計師公會」)發佈的香港會計準則(「香港會計準則」)第34號
中期財務報告 。該報告已獲授權於二零二六年八月三十一日發佈。
中期財務報告按照二零二五年度財務報表中採用的相同會計政策編製,惟預計將於二零二
六年度財務報表中反映的會計政策變動除外。會計政策任何變動的詳情載於附註2.2。
編製符合香港會計準則第34號的中期財務報告時,管理層須作出判斷、估計及假設,而該
等判斷、估計及假設會影響政策應用及以本年至今為基準資產及負債、收入及開支的已呈
報金額。實際結果可能與預估的有所不同。
本中期財務報告包含簡明綜合財務報表及節選附註解釋。附註包括對了解本集團自二零二
五年度財務報表以來的財務狀況及業績變動而言屬重大的事項及交易的解釋。簡明綜合中
期財務報表及隨附附註並不包括按照香港財務報告會計準則編製完整財務報表所需的全部
資料。
中期財務報告未經審核,但已由畢馬威會計師事務所按照香港會計師公會頒佈的香港審閱
委聘準則第2410號實體獨立核數師進行中期財務資料審閱 進行審閱。
2.2
會計政策及披露事項變動
香港會計師公會已頒佈若干香港財務報告會計準則修訂,該等修訂自本會計期間起首次生
效,其中包括:
•
香港財務報告準則第9 號(修訂本),財務工具 及香港財務報告準則第7 號,財務工
具:披露 - 涉及依賴自然能源生產電力的合同
•
香港財務報告準則第9 號(修訂本),財務工具 及香港財務報告準則第7 號,財務工
具:披露 - 財務工具分類及計量之修訂
•
香港財務報告準則之年度改進 - 第11卷
由於本集團並無進行此類交易,故該等修訂對本中期報告並無重大財務影響。
本集團尚未採用於當前會計期間尚未生效的任何新準則或解釋。
29
3.
收入及分部報告
(a)
收入
(i)
收入明細
按產品或服務線劃分的客戶合約收入明細如下:
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
國際財務報告準則第15號範圍內的
客戶合約收入
(b)
隨時間確認:
- 提供研發服務
- 其他
–
–
1,054
27
總計
–
1,081
分部報告
經營分部乃根據本集團最高行政管理層定期審閱分配予分部資源及評估其表現的內
部報告識別。
本集團的最高行政管理層根據內部管理職能作出資源分配決策,並將本集團的業務
表現作為一項綜合業務(而非透過單條業務線或地理區域)進行評估。因此,本集團
僅擁有一個經營分部,且因此並無呈列任何分部資料。
(c)
地區資料
下表載列有關:(i)本集團來自外部客戶的收入;及(ii)本集團的物業、廠房及設備
以及無形資產(「特定非流動資產」)所在地區的資料。客戶所在地區按其經營地點劃
分。特定非流動資產所在地區,如屬物業、廠房及設備,則按資產實際所在地點劃
分,而如屬無形資產,則按所分配的經營地點劃分。
(i)
來自外部客戶的收入
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
(ii)
香港
其他地區
–
–
1,054
27
總計
–
1,081
二零二六年
六月三十日
人民幣千元
二零二五年
十二月三十一日
人民幣千元
中國內地
美國
44,741
4
49,906
4
總計
44,745
49,910
非流動資產
30
4.
其他收入及收益
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
銀行利息收入
權益投資產生已變現及未變現收益淨額
理財產品及結構性存款產生的已變現及
未變現收益淨額
按公平值計入其他全面收入的金融資產的
已變現及未變現收益淨額
政府補助(i)
匯兌虧損淨額
其他
總計
39,466
17,336
30,037
37,679
3,643
1,472
709
1,188
(10,110)
747
431
34,175
(1,308)
10
52,979
102,496
附註:
(i)
5.
政府補助主要指由地方政府為補償研究活動、臨床試驗及日常經營活動產生的開
支、若干項目產生的資本開支及新藥研製獎勵而提供的補助。
除稅前虧損
本集團除稅前虧損乃經扣除 ╱(計入)下列各項得出:
(a)
融資成本
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
租賃負債利息
(b)
74
87
其他項目
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
物業、廠房及設備項目折舊
使用權資產折舊
無形資產攤銷
撇減存貨至可變現淨值
核數師酬金
訴訟開支
以股權結算的股份獎勵及期權開支
6.
5,469
2,151
953
16
551
836
3,274
5,470
2,756
1,214
23
551
1,899
3,836
所得稅
本集團須按實體基準就產生自或源自本集團成員公司註冊及營運所在司法權區的溢利繳納
所得稅。
開曼群島
根據開曼群島現行法律,本公司毋須就收入或資本收益繳納稅項。此外,開曼群島不會對
本公司向其股東派付的股息徵收預扣稅。
31
英屬處女群島
根據英屬處女群島(「英屬處女群島」)現行法律,PowerTree Investment (BVI) Ltd.
(「PowerTree」)毋須就收入或資本收益繳納稅項。此外,英屬處女群島不會對PowerTree
向其股東派付的股息徵收預扣稅。
香港
根據香港現行法例,香港附屬公司須就於香港產生的估計應課稅溢利按16.5%(二零二五
年:16.5%)的稅率繳納利得稅。於報告期內,由於附屬公司並無於香港產生任何應課稅
溢利,故並無作出利得稅撥備。
美國
根據美國現行法律,美國附屬公司須按最高21%(二零二五年:21%)的聯邦企業所得稅稅
率及2.5%(二零二五年:2.5%)的北卡羅來納州稅率繳納稅項。於報告期內,由於該附屬
公司並無於美國產生任何應課稅收入,故並無作出所得稅撥備。
澳洲
根據澳洲現行法律,澳洲附屬公司須按30%(二零二五年:30%)的稅率繳納利得稅。於報
告期內,由於該附屬公司並無於澳洲產生任何應課稅收入,故並無作出所得稅撥備。
中國內地
根據中國企業所得稅法及相關法規(「企業所得稅法」),在中國內地營運的附屬公司須按
25%(二零二五年:25%)的稅率就應課稅收入繳納企業所得稅。
根據企業所得稅法,非居民企業在中國境內未設立機構、場所的,或者雖設立但所得與其
無實際聯繫的,應當就其來源於中國境內的股息等各類被動所得按10%的稅率預扣預繳所
得稅(根據稅收協定予以減免的除外)。
歌禮藥業(浙江)有限公司(「歌禮藥業」)由於被認定為高新技術企業,故報告期內納稅享
有15%的優惠稅率(二零二五年:15%)。
若干中國附屬公司由於被認定為小微企業,故享有5%的優惠中國所得稅稅率。
根據中國國家稅務總局於二零二三年三月頒佈且自二零二三年一月一日起施行的新稅收優
惠政策,符合條件的已產生研發開支可自應課稅收入中加計扣除100%。
7.
每股虧損
每股基本虧損乃根據本公司普通權益股東應佔虧損人民幣319,671,000元(截至二零二五年
六月三十日止六個月:人民幣87,951,000元),及於中期期間發行的1,039,794,415股(截至
二零二五年六月三十日止六個月:962,522,870股)普通股之加權平均數計算。
由於股份獎勵及期權的影響對所示每股基本虧損金額具有反攤薄影響,故並無就有關攤薄
對截至二零二六年及二零二五年六月三十日止期間所示的每股基本虧損金額作出調整。
32
8.
物業、廠房及設備
截至二零二六年六月三十日止六個月期間,本集團以成本人民幣1,233,000元收購資產(截
至二零二五年六月三十日止六個月:人民幣1,072,000元)。
截至二零二六年六月三十日止六個月期間,出售賬面淨值人民幣9,000元的廠房及機器項
目(截至二零二五年六月三十日止六個月:人民幣50,000元),導致出售虧損人民幣9,000
元(截至二零二五年六月三十日止六個月:人民幣50,000元)。
9.
使用權資產
於截至二零二六年六月三十日止六個月,本集團並無簽訂任何新辦公室租賃協議,故期內
並無確認添置使用權資產(截至二零二五年六月三十日止六個月:人民幣2,121,000元)。
10. 貿易應收款項
截至報告期末按發票日期呈列並經扣除虧損撥備的貿易應收款項的賬齡分析如下:
二零二六年
六月三十日
人民幣千元
二零二五年
十二月三十一日
人民幣千元
–
223
二零二六年
六月三十日
人民幣千元
二零二五年
十二月三十一日
人民幣千元
14,623
1,344
少於三個月
11. 貿易應付款項
截至報告期末按發票日期呈列的貿易應付款項的賬齡分析如下:
少於三個月
12. 資本、儲備及股息
(a)
股息
董事會不建議就截至二零二六年六月三十日止六個月派付任何股息(截至二零二五年
六月三十日止六個月:無)。
(b)
股本
(i)
已發行股本
二零二六年
股份數目
人民幣千元
二零二五年
股份數目
人民幣千元
普通股,已發行及已繳足:
於一月一日
註銷股份
發行股份
998,958,530
–
69,496,525
679
–
48
1,012,758,000
(44,896,790)
1,569,285
689
(32)
1
於六月三十日
1,068,455,055
727
969,430,495
658
本公司普通股的面值為每股0.0001美元。
33
(ii)
購回自身股份
於中期期間,本公司於聯交所購回其自身股份如下:
年╱月
二零二六年六月
已購回股份
數目
每股已付
最高價格
港元
每股已付
最低價格
港元
已付價格
總額(包括
交易費用)
千港元
3,745,000
10.77
9.14
37,300
購回股份的已付總額37,300,000港元(相當於人民幣32,438,000元)已悉數支付。
(iii) 註銷已購回股份
截至二零二六年六月三十日止六個月,本公司並無註銷任何已購回股份(截至二零二
五年六月三十日止六個月:44,896,790股股份)。
(iv) 根據購股權計劃已發行股份
截至二零二六年六月三十日止六個月,已行使購股權認購本公司240,525股(截至二
零二五年六月三十日止六個月:1,569,285 股)普通股,代價為人民幣371,000元(截
至二零二五年六月三十日止六個月:人民幣3,849,000元)。少於人民幣1,000元(截至
二零二五年六月三十日止六個月:人民幣1,000元)已計入股本,而人民幣371,000元
(截至二零二五年六月三十日止六個月:人民幣3,848,000元)已計入資本儲備。
(v)
配售新股份
於二零二六年二月十日,本公司成功向不少於六名配售對象配發及發行合共
69,256,000 股新股份(「配售股份」),該等配售對象及其最終實益擁有人均為獨立於
本公司且與本公司、本公司關連人士及本公司或其任何附屬公司之任何董事、監
事、行政總裁或主要股東或其各自聯繫人無關聯之獨立第三方,每股配售股份的配
售價為12.18港元。配售股份約佔經配發及發行配售股份而擴大之已發行股份總數的
6.53%。此次配售的所得款項淨額(扣除佣金及估計開支後)約為835.2百萬港元(相
當於人民幣742.3 百萬元)。更多詳情請參閱本公司日期為二零二六年二月十日之公
告。
(c)
以股權結算以股份為基礎的交易
本公司於二零二五年二月三日採納一項購股權計劃(「二零二五年購股權計劃」)及一
項股份獎勵計劃(「二零二五年股份獎勵計劃」)。該等計劃旨在獎勵董事及僱員為本
集團提供服務,並激勵彼等進一步為本集團作出貢獻。
每份購股權賦予持有人認購一股本公司普通股的權利。該等購股權將於二零二六年
一月十四日至二零二九年一月十四日期間歸屬,並可於二零三五年之前行使。股份
獎勵將於達到特定表現目標後方可歸屬。
截至二零二六年六月三十日止六個月,本公司概無授出任何購股權或股份獎勵(截至
二零二五年六月三十日止六個月:4,820,175份購股權及5,784,210份股份獎勵)。
34
13. 或然負債
(a)
Viking案
於二零二二年十二月二十九日,Viking Therapeutics, Inc.(「Viking」)
(一家位於美
國的製藥公司)就本集團的候選藥物ASC41及ASC43F向本公司、其創始人吳勁梓及
本公司若干附屬公司作出若干控告。一項控告向位於華盛頓特區的美國國際貿易委
員會(「ITC」)提出,另一項控告則向加利福尼亞州南區聖迭戈分部的美國地方法院
(「USDC」)提出,各項控告所列指控相似。
於二零二四年十月四日及二零二五年五月二十九日,本公司收到ITC對該控告的初步
裁定及最終裁定(統稱「裁定」)。ITC行政法官(Administrative Law Judge)作出的裁
定認為,本公司候選藥物ASC41和ASC43F進口至美國違反《1930年關稅法案》
(修訂
版)第337條。此外,由於調查階段的若干程序問題,提出處以567,000美元(相當於
約人民幣4,038,000 元)的經濟制裁。本公司已在財務報表中對該項經濟制裁作出撥
備。
關於向USDC提出的控告,自二零二六年一月一日起並無重大進展,相關調查及訴訟
程序仍在進行中。本公司將就該等控告進行有力抗辯。據此,於二零二六年六月三
十日,本集團並無對因Viking向USDC提出的控告所引起的指控作出任何撥備。
(b)
仲裁案
於二零二五年九月,歌禮藥業捲入了一宗由先前客戶發起的仲裁程序,該程序主要
源於有關若干產品的商業合約糾紛。
申訴人要求賠償總額約人民幣25百萬元,其中包括(i)合約付款,(ii)涉嫌佔用資金的
利息,及(iii)仲裁和法律費用。
於本公告日期,仲裁仍在進行中,尚未作出裁決。根據目前可獲得的信息,無法可
靠地估計仲裁結果及其對本集團的潛在財務影響。於二零二六年六月三十日,本集
團概無就該仲裁作出任何撥備。
35
遵守企業管治守則
本公司致力維持高水平的企業管治,以保障股東權益,提升企業價值,制定其業
務戰略及政策以及提高其透明度及問責性。
本公司已採納上市規則附錄C1所載的企業管治守則的守則條文作為其企業管治的
守則。
董事會認為,本公司於報告期內一直遵守企業管治守則內的所有適用守則條文,
惟偏離企業管治守則第2分部守則條文第C.2.1條,即本公司的董事會主席與行政
總裁的職位並非分開,均由吳博士擔任。本公司是一家擁有專業管理團隊以監管
其附屬公司經營的投資控股公司。董事會認為,董事會主席及行政總裁的職位由
同一人兼任能更有效率地引領及管理本公司,且並不損害董事會的權力及權限與
本公司業務管理的平衡。董事會將不時審閱企業管治架構及慣例,並會在其認為
適當時作出必要安排。
遵守證券交易標準守則
本公司已採納一套其標準不遜於標準守則的書面指引作為其董事進行證券交易的
行為守則。
經向全體董事作出具體查詢後,各位董事均確認彼等於整個報告期間及直至本公
告日期已遵守標準守則及書面指引。於報告期內,本公司並無發現可能掌握本公
司內幕消息的僱員存在不遵守書面指引的情況。
購買、出售或贖回本公司上市證券
本公司不時購回股份,旨在長遠提高股東價值,並為董事會提供更多靈活性以按
現行市價轉售庫存股份,為本公司籌集額外資金,或根據上市規則第十七章的股
份計劃轉讓庫存股份或用作股份授出,或將其用於上市規則、章程細則及開曼群
島適用法例准許的其他用途。於報告期內,本公司於聯交所購回合共3,745,000股
股份,總代價為37,227,010港元,主要用於提高股份價值,從而惠及全體股東。
於報告期內及直至本公告日期,本公司以總代價55,954,050港元,於聯交所購回
本公司合共5,745,000 股股份。於本公告日期,為註銷而購回的9,386,000 股普通
股及1,300,000股庫存股份已經註銷,及於本公告日期,已發行股份總數已相應減
少。
於報告期及直至本公告日期購回的股份詳情如下:
36
成交月份
二零二六年六月
二零二六年七月
總計
已購回股份數目
及購回方式
3,745,000股股份
於聯交所購回
2,000,000股股份
於聯交所購回
每股價格
已付
已付
每股
每股
最高價 最低價
(港元) (港元)
已付總代價
(港元)
10.77
9.14
37,227,010.00
11.67
8.01
18,727,040.00
5,745,000
55,954,050.00
除上文所述者外,於報告期及直至本公告日期,本公司或其任何附屬公司概無購
買、出售或贖回本公司任何上市證券(包括出售庫存股)。
於二零二六年六月三十日,就上市規則而言,本公司持有7,084,210股庫存股,該
等庫存股用於本公司股份計劃,包括二零二五年股份獎勵計劃。詳情請參閱本公
司日期分別為二零二五年一月十四日的公告及二零二五年一月十五日的通函,以
及本公司日期為二零二五年二月三日的股東特別大會投票結果公告。
董事信息變更
於報告期內,董事會並不知悉董事資料的任何變更須根據上市規則第13.51B(1)條
予以披露。
中期業績審閱
本公司的獨立核數師畢馬威會計師事務所已根據香港會計師公會頒佈的香港審閱
委聘準則第2410號「實體獨立核數師進行中期財務資料審閱」對中期財務資料進行
審閱。
審核委員會由三名獨立非執行董事組成,即顧炯先生、魏以楨博士及華林女士。
顧炯先生為審核委員會主席。審核委員會已與管理層共同審閱本公司所採納的會
計原則及政策,並討論本集團的內部監控及財務報告事宜(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)。審核委員會認為中期業績符合適
用會計準則、法律及法規,且本公司已就此作出適當披露。董事會與審核委員會
之間對會計準則的選擇、應用及詮釋、本公司採納的會計處理或報告期內管理層
編製及呈列的中期財務資料並無意見分歧。
報告期後事項
報告期後及直至本公告日期,並無重大期後事項。
37
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。
刊載中期業績及中期報告
本公告刊載於聯交所網站( www.hkexnews.hk )及本公司網站( www.ascletis.com )。
截至二零二六年六月三十日止六個月之中期報告載有上市規則所規定之全部資
料,將適時寄發予需要印刷本的股東及在聯交所及本公司網站上刊載。
致謝
董事會謹此對股東、本集團的管理團隊、僱員、業務夥伴及客戶向本集團作出之
支持及貢獻表示衷心感謝。
38
釋義
「二零二五年購股權計劃」
指
本公司於二零二五年二月三日採納的二零二
五年購股權計劃
「二零二五年股份獎勵計劃」 指
本公司於二零二五年二月三日採納的二零二
五年股份獎勵計劃
「章程細則」
指
本公司組織章程細則
「歌禮」、「公司」、
「本公司」或「我們」
指
歌禮製藥有限公司,一家於二零一四年二月
二十五日在開曼群島註冊成立的獲豁免有限
公司
「歌禮生物科技」
指
歌禮生物科技(杭州)有限公司,一家於二零
一三年四月二十六日在中國成立的有限責任
公司,為本公司的間接全資附屬公司
「歌禮製藥(中國)」
指
歌禮製藥(中國)有限公司,一家於二零一八
年三月十五日在香港註冊成立的有限責任公
司,為本公司的間接全資附屬公司
「歌禮藥業」
指
歌 禮 藥 業( 浙 江 )有 限 公 司 , 一 家 於 二 零 一
四年九月二十四日在中國成立的有限責任公
司,為本公司的間接全資附屬公司
「審核委員會」
指
董事會審核委員會
「董事會」
指
本公司董事會
「cAMP」
指
環磷酸腺苷
「企業管治守則」
指
上市規則附錄C1所載的企業管治守則
「主席」
指
董事會主席
「中國」或「中國內地」
指
中華人民共和國,就本公告而言,不包括香
港、澳門特別行政區及台灣
「董事」
指
本公司董事
「DIO」
指
飲食誘導肥胖
「吳博士」
指
吳勁梓博士,本公司創辦人、董事會主席、
行政總裁及控股股東之一,亦為何淨島女士
的配偶
39
「EMA」
指
歐洲藥品管理局
「FASN」
指
脂肪酸合成酶
「FDA」
指
美國食品藥品監督管理局
「FDC」
指
固定劑量複方製劑
「按公平值計入其他
全面收入」
指
按公平值計入其他全面收入
「按公平值計入損益」
指
按公平值計入損益
「GCGR」
指
胰高血糖素受體
「GIPR」
指
葡萄糖依賴性促胰島素多肽受體
「GLP-1R」
指
胰高血糖素樣肽-1受體
「本集團」
指
本公司及其附屬公司
「hAMY1R」
指
人胰淀素1型受體
「hCTR」
指
人降鈣素受體
「港元」
指
港元,香港法定貨幣
「香港」
指
中國香港特別行政區
「IL-17A和F」
指
白細胞介素-17A和F
「IND」
指
研究性新藥,製藥公司於藥品上市申請獲批
之前獲准經司法權區運送(通常運往臨床調查
人員)的實驗性藥品
「上市規則」
指
聯交所證券上市規則(經不時修訂或補充)
「MAA」
指
上市許可申請
「主板」
指
聯交所主板
「標準守則」
指
上市規則附錄C3 所載的上市發行人董事進行
證券交易的標準守則
「NDA」
指
新藥上市申請
「非人靈長類動物」
指
非人靈長類動物
40
「國家藥監局」
指
中國國家藥品監督管理局
「購股權」
指
根據二零二五年購股權計劃的條款向承授人
授出以認購股份的購股權
「QD」
指
每日一次
「研發」
指
研究及開發
「人民幣」
指
人民幣元,中國法定貨幣
「報告期」
指
自二零二六年一月一日起至二零二六年六月
三十日止六個月期間
「SAD」
指
單劑量遞增
「Sagimet」
指
Sagimet Biosciences Inc.,一家於二零零六
年十二月在特拉華州註冊成立的公司,其股
份於納斯達克股票交易所上市(股份代碼:
SGMT)
「SALD」
指
自組裝脂質儲庫
「股份」
指
本公司股本中每股面值0.0001美元的普通股
「股份獎勵」
指
根據二零二五年股份獎勵計劃的條款授予承
授人以認購股份的股份獎勵
「股東」
指
股份持有人
「皮下」
指
皮下
「STAT6」
指
信號轉導和轉錄激活因子6
「聯交所」
指
香港聯合交易所有限公司
「美國」
指
美利堅合眾國
「美元」
指
美利堅合眾國法定貨幣美元
「對比」
指
對比
「書面指引」
指
本公司採納的關於董事進行證券交易的指引
「%」
指
百分比
41
於本公告內,除文義另有所指外,「聯繫人」、「關連人士」、「控股股東」及「附屬
公司」等詞彙應具有上市規則賦予該等詞彙之涵義。
承董事會命
Ascletis Pharma Inc.
歌禮製藥有限公司
主席
吳勁梓
香港
二零二六年八月三十一日
於本公告日期,董事會包括執行董事吳勁梓博士及何淨島女士;及獨立非執行董
事魏以楨博士、顧炯先生及華林女士。
42
for the contents of this announcement, make no representation as to its accuracy or completeness and expressly
disclaim any liability whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the
contents of this announcement.
This announcement contains forward-looking statements that involve risks and uncertainties. All statements other
than statements of historical fact are forward-looking statements. These statements involve known and unknown risks,
uncertainties and other factors, some of which are beyond the Company ’s control, that may cause the actual results,
performance or achievements to be materially different from those expressed or implied by the forward-looking
statements. You should not rely upon forward-looking statements as predictions of future events. The Company
undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information,
future events or otherwise.
Ascletis Pharma Inc.
歌禮製藥有限公司
(Incorporated in the Cayman Islands with limited liability)
STOCK CODE: 1672
INTERIM RESULTS ANNOUNCEMENT
FOR THE SIX MONTHS ENDED JUNE 30, 2026
The Board hereby announces the unaudited consolidated interim results of the Group for the six
months ended June 30, 2026, together with the comparative figures for the corresponding period in
2025 as follows.
FINANCIAL HIGHLIGHTS
Unaudited
Six months ended June 30,
2026
2025
Changes
(RMB ’000)
(RMB ’000)
%
Total income(1)
Research and development costs
Administrative expenses
Other expenses
Finance costs
Loss before taxation
Income tax
Loss for the period
Attributable to:
Equity shareholders of the Company
Loss per share
Basic and diluted
52,979
(341,663)
(30,803)
(12)
(74)
(319,573)
(98)
(319,671)
103,577
(146,812)
(43,302)
(367)
(87)
(87,951)
–
(87,951)
(48.9)
132.7
(28.9)
(96.7)
(14.9)
263.4
–
263.5
(319,671)
(87,951)
263.5
RMB
RMB
(30.74) cents
(9.14) cents
Note:
(1)
The Group’s total income represents revenue, other income and gains.
1
CORPORATE PROFILE
Our Vision
Ascletis’ vision is to become the most innovative world-class biomedical company addressing
global unmet medical needs in the area of metabolic diseases.
Overview
During the Reporting Period and up to the date of this announcement, the Group made significant
progress for its metabolic disease pipeline:
(i)
The global Phase III clinical program for ASC30 chronic weight management indication has
been initiated, consisting of two pivotal global Phase III, multicenter, randomized, doubleblind, placebo-controlled trials (AURORA-1 and AURORA-2) in a total of approximately
4,600 participants with obesity or overweight in the U.S., Europe, and Canada. Recently, the
first participant has been dosed in the global Phase III clinical program of ASC30 for chronic
weight management. The Group expects to announce topline data from the ASC30 Phase III
clinical program in the third quarter of 2028, with an FDA NDA filing expected by the end of
2028 and an EMA MAA filing expected in early 2029. The Group has sufficient cash on hand
to support its operations into 2029, beyond the expected submission of an NDA and an MAA
for ASC30.
(ii)
ASC30 oral small molecule GLP-1 once-daily tablet for diabetes is being evaluated in a U.S.
13-week Phase II study. Topline data are expected in the third quarter of 2026.
(iii) ASC39, a potentially first-in-class once-daily oral small molecule eloralintide-like selective
amylin receptor agonist (SARA), demonstrated eloralintide-like amylin selectivity and
efficacy in preclinical models, and submission of an IND application to the FDA for ASC39
oral tablets is expected in the third quarter of 2026.
(iv) ASC30_39FDC, a fixed-dose combination of ASC30 and ASC39 has been selected as
a clinical development candidate, and submission of an IND application to the FDA for
ASC30_39FDC oral tablets is expected in the third quarter of 2026.
(v)
ASC30_48FDC, a fixed-dose combination of ASC30 and ASC48, a potentially first-in-class
oral small molecule GIPR agonist, has been selected as a clinical development candidate, and
submission of an IND application to the FDA for ASC30_48FDC oral tablets is expected in
the fourth quarter of 2026.
(vi) ASC30_48_39FDC, a fixed-dose combination of ASC30, ASC48, and ASC39 has been selected for
clinical development, and submission of an IND application to the FDA for ASC30_48_39FDC
oral tablets is expected in the fourth quarter of 2026.
(vii) ASC36, a once-monthly to once-quarterly, potentially best-in-class subcutaneously administered
amylin receptor agonist for obesity, has obtained the IND clearance by the FDA and topline
pharmacokinetic data are expected to be announced by the end of 2026.
(viii) ASC36 oral tablets, the Company’s first oral amylin receptor peptide agonist, has submitted
an IND application to the FDA and Phase I trials are expected to be initiated in the third
quarter of 2026.
2
(ix) ASC35, a once-monthly potentially best-in-class subcutaneously administered GLP-1R/GIPR
dual peptide agonist for obesity has obtained the IND clearance by the FDA and topline
pharmacokinetic data are expected to be announced by the end of 2026.
(x)
ASC36_35FDC, a fixed-dose combination of ASC36 and ASC35, has obtained the IND clearance
by the FDA and topline pharmacokinetic data are expected to be announced at the beginning
of the first quarter of 2027.
(xi) ASC37 injection, a next-generation, once-monthly, subcutaneously administered GLP-1R/
GIPR/GCGR triple peptide agonist, has been selected as a clinical development candidate and
submission of an IND application to the FDA for ASC37 injection is expected in the third
quarter of 2026.
(xii) ASC37 oral tablet has been selected as a clinical development candidate and submission of
an IND application to the FDA for ASC37 oral tablet is expected in the third quarter of 2026.
(xiii) ASC36_37FDC, a fixed-dose combination of ASC36 and ASC37, has been selected for
clinical development, and submission of an IND application to the FDA for ASC36_37FDC
injection is expected in the third quarter of 2026.
During the Reporting Period and up to the date of this announcement, the Group made significant
progress for its immune disease pipeline:
(i)
ASC50, an IL-17A oral small molecule inhibitor, has completed the U.S. Phase I SAD study
in healthy subjects and the U.S. Phase I proof of concept (POC) 28-day study (200 mg QD) in
mild-to-moderate plaque psoriasis patients. Human data suggest that ASC50 is a potentially
first-in-class and best-in-class oral small molecule IL-17A inhibitor.
(ii)
ASC51, a potent, selective, and once-daily oral STAT6 degrader, is an FDA-IND ready
candidate. ASC51 has completed all IND-enabling studies required by the FDA and is
potentially the second-in-class STAT6 oral small molecule degrader after KT-62.
(iii) ASC52 has the potential to be the best-in-class IL-17AA, AF and FF oral cyclic peptide
antagonist and its IND filing to the FDA is expected in the fourth quarter of 2026. ASC52 is
the potentially second-in-class IL-17AA, AF and FF oral cyclic peptide antagonist after PN881.
These achievements underscored the Group ’ s strong R&D capabilities, best execution and
longstanding commitments to discovering and developing global best-in-class/first-in-class pipeline
to address unmet clinical needs.
As at June 30, 2026, the Group had cash and cash equivalents, time deposits, transferable certificates
of deposit, structured deposits and wealth management products of approximately RMB2,305.4
million (June 30, 2025: approximately RMB1,827.9 million) to support its operations into 2029.
3
The R&D costs of the Group increased by 132.7% from approximately RMB146.8 million for
the six months ended June 30, 2025 to approximately RMB341.7 million for the six months
ended June 30, 2026. The significant increase in R&D expenses is primarily due to the Group ’s
strategic commitment to advance its comprehensive metabolic disease pipeline, including both
small molecules and peptides. The loss for the period of the Group increased by 263.5% from
approximately RMB88.0 million for the six months ended June 30, 2025 to approximately
RMB319.7 million for the six months ended June 30, 2026, primarily due to the increase in R&D
costs described above.
During the Reporting Period and up to the date of this announcement, the Group’s pipelines and
their progress are summarized below:
4
Metabolic Disease Pipeline - Small Molecules
Product
(Modality)
Target
Indication
Commercial
Rights
ASC30
(Once-daily oral small
molecule agonist)
GLP-1R
Obesity
Global
ASC30
(Once-daily oral small
molecule agonist)
GLP-1R
Diabetes
Global
ASC39
(Once-daily oral small
molecule agonist)
Amylin Receptor SARA
Obesity
Global
ASC30_39FDC
(Once-daily oral small
molecule dual agonist)
GLP-1R/
Amylin Receptor SARA
Obesity
Global
ASC30_48FDC
(Once-daily oral small
molecule dual agonist)
GLP-1R/GIPR
Obesity
Global
ASC30_48_39FDC
(Once-daily oral small
molecule triple agonist)
GLP-1R/GIPR/
Amylin Receptor SARA
Obesity
Global
Discovery
IND Enabling
Phase I
Phase II
Phase Ⅲ
Discovery
IND Enabling
Phase I
Phase II
Phase Ⅲ
Discovery
IND Enabling
Phase I
Phase II
Phase Ⅲ
Metabolic Disease Pipeline - Peptides
Product
(Modality)
Target
Indication
Commercial
Rights
ASC36i
(Once-monthly to oncequarterly subcutaneous
peptide agonist)
Amylin Receptor
Obesity
Global
ASC36o
(Oral peptide agonist)
Amylin Receptor
Obesity
Global
ASC35
(Once-monthly subcutaneous
peptide agonist)
GLP-1R/GIPR
Obesity
Global
ASC36_35FDC
(Once-monthly subcutaneous
triple peptide agonist)
Amylin Receptor+
GLP-1R/GIPR
Obesity
Global
ASC37i
(Once-monthly subcutaneous
triple peptide agonist)
GLP-1R/GIPR/GCGR
Obesity
Global
ASC37o
(Oral peptide agonist)
GLP-1R/GIPR/GCGR
Obesity
Global
ASC36_37FDC
(Once-monthly subcutaneous
quadruple peptide agonist)
Amylin Receptor+
GLP-1R/GIPR/GCGR
Obesity
Global
Immune Disease Pipeline
Product
(Modality)
Target
Indication
Commercial
Rights
ASC50
(Once-daily oral small
molecule inhibitor)
IL-17A
Psoriasis and other
immune diseases
Global
ASC51
(Once-daily oral small
molecule degrader)
STAT6
Immune diseases
Global
ASC52
(Once-daily oral cyclic peptide
inhibitor)
IL-17A and F
Immune diseases
Global
Exploratory Indication Pipeline
Product
(Modality)
Target
Indication
Commercial
Rights
ASC40
(Oral small molecule)
FASN
ACNE
Greater China1
Discovery
IND Enabling
Phase I
Phase II
Phase Ⅲ
NDA
Note:
1. Denifanstat (ASC40) is licensed from Sagimet for the exclusive rights in Greater China.
Abbreviations:
GLP-1R: glucagon-like peptide 1 receptor; SARA: selective amylin receptor agonist; FDC: fixed-dose
combination; GIPR: gastric inhibitory polypeptide receptor; GCGR: glucagon receptor; STAT6: Signal
Transducer and Activator of Transcription 6; IL-17A and F: interleukin-17A and F; FASN: Fatty acid
synthase.
5
MANAGEMENT DISCUSSION AND ANALYSIS
BUSINESS REVIEW
During the Reporting Period and up to the date of this announcement, the Group has made the
following progress with respect to its business.
Metabolic Diseases
Small Molecules
ASC30 oral once-daily tablet for obesity
During the Reporting Period and up to the date of this announcement, the Group has received
Phase III clearance from the FDA and initiated a global Phase III clinical program for ASC30
chronic weight management indication consisting of two pivotal global Phase III, multicenter,
randomized, double-blind, placebo-controlled trials (AURORA-1, NCT07743463 and AURORA-2,
NCT07743450) in a total of approximately 4,600 participants with obesity or overweight in the
U.S., Europe, and Canada. Recently, the first participant has been dosed in the global Phase III
clinical program of ASC30 for chronic weight management.
The two pivotal studies will investigate the long-term efficacy, safety, and tolerability of three
maintenance doses (20 mg, 40 mg and 60 mg) of once-daily oral ASC30 compared with placebo in
participants with obesity or overweight without type 2 diabetes (AURORA-1) and in participants
with obesity or overweight with type 2 diabetes (AURORA-2). The treatment duration of both
AURORA-1 and AURORA-2 are 72 weeks.
The Company expects to announce topline data from the ASC30 Phase III clinical program in the
third quarter of 2028, with an FDA NDA filing expected by the end of 2028 and an EMA MAA
filing expected in early 2029. If approved by the respective regulatory authorities in the U.S. and
Europe, this will make ASC30 potentially the second oral small molecule GLP-1 approved in the
U.S. and Europe after orforglipron.
Anticipated 2026 Milestone: The Group has achieved the 2026 milestone as the first participant
has been dosed in the global Phase III clinical program of ASC30 for chronic weight management.
ASC30 oral once-daily tablet for diabetes
During the Reporting Period and up to the date of this announcement, the Group has completed
enrollment in its 13-week U.S. Phase II study (NCT07321678) evaluating ASC30, an oral small
molecule GLP-1R agonist, for the treatment of type 2 diabetes mellitus (T2D). T2D is the second
indication for ASC30, following its first indication of obesity.
Anticipated 2026 Milestone: Expected to announce the topline data from the U.S. 13-week Phase
II study of ASC30 oral once-daily tablet for the treatment of diabetes in the third quarter of 2026.
6
ASC39 once-daily oral tablet for obesity
During the Reporting Period and up to the date of this announcement, the Group has selected
ASC39, a potentially first-in-class once-daily oral small molecule eloralintide-like selective amylin
receptor agonist (SARA), as a clinical development candidate.
In a head-to-head cAMP activation assay vs. eloralintide, oral small molecule amylin receptor
agonist ASC39 demonstrated similar selectivity and potency to that of eloralintide. EC50 for
hAMY1R was 21.4 pM and 21.2 pM for ASC39 and eloralintide, respectively. EC50 for hCTR was
846.1 pM and 1,350.8 pM for ASC39 and eloralintide, respectively. These data indicate ASC39
and eloralintide have similar selectivity for hAMY1R over hCTR.
In a head-to-head DIO rat study vs. eloralintide, efficacy of ASC39 oral dosing was comparable to
that of eloralintide, demonstrating significant placebo adjusted weight loss of 6.6% and 5.6% for
ASC39 and eloralintide, respectively.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC39 oral
tablets for the treatment of obesity in the third quarter of 2026.
ASC30_39FDC once-daily oral tablet for obesity
During the Reporting Period and up to the date of this announcement, the Group has selected
ASC30_39FDC, a fixed-dose combination of ASC30, once-daily oral small molecule GLP-1R
agonist and ASC39, a potentially first-in-class once-daily oral small molecule eloralintide-like
SARA, for clinical development.
ASC30_39FDC tablets, dosed orally in dogs, demonstrated comparable pharmacokinetics to those
observed in their respective monotherapies in a head-to-head study. The fixed-dose combination
had excellent oral bioavailability, drug exposure and a half-life of up to 12 hours. These data
support ASC30_39FDC tablets as a potential novel one-pill, once-daily therapy for obesity.
ASC30_39FDC demonstrated excellent compatibility between ASC30 and ASC39 when combined
together, with room temperature stability and a small pill size.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC30_39FDC
oral tablets for the treatment of obesity in the third quarter of 2026.
ASC30_48FDC once-daily oral tablet for obesity
During the Reporting Period and up to the date of this announcement, the Group has selected a
fixed-dose combination of ASC48, a potentially first-in-class oral small molecule GIPR agonist,
and ASC30, an oral small molecule GLP-1R agonist, for clinical development. ASC30_48FDC is a
potentially first-in-class oral one-pill, once-daily therapy for obesity, targeting GLP-1R and GIPR.
ASC48 demonstrated an EC50 of 1 pM in the hGIPR cAMP activation assay, exhibiting greater
potency than tirzepatide (EC50 = 3 pM) and is a selective agonist for GIPR without activity for
GLP-1R and GCGR.
7
ASC48 demonstrated excellent oral bioavailability and drug exposure as well as long half-life in
rodents and NHPs, supporting once-daily oral dosing in humans.
ASC30_48FDC demonstrated approximately 52% greater relative body weight reduction compared
to ASC30 monotherapy in a head-to-head NHP study.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC30_48FDC
oral tablets for the treatment of obesity in the fourth quarter of 2026.
ASC30_48_39FDC once-daily oral tablet for obesity
During the Reporting Period and up to the date of this announcement, the Group has announced
positive data for its potentially first-in-class once-daily oral small molecule GLP-1/GIP/amylin
triple agonist fixed-dose combination. It demonstrated a GIPR agonist (ASC48) dose-dependent,
statistically significant body weight reduction of up to 15.2% in NHPs after seven-day treatment.
This represents an up to 120% greater relative body weight reduction compared to oral dual agonist
fixed-dose combination targeting GLP-1R and amylin receptor (SARA) (ASC30_39FDC). The data
suggest that GIP component (ASC48) is critical to ASC30_48_39FDC triple agonist.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC30_48_39FDC
oral tablets for the treatment of obesity in the fourth quarter of 2026.
Peptides
ASC36 once-monthly to once-quarterly SQ peptide for obesity
During the Reporting Period and up to the date of this announcement, the Group has obtained the
IND clearance by the FDA and initiated the Phase I study of ASC36, a once-monthly to oncequarterly next-generation amylin receptor peptide agonist.
ASC36 once-monthly to once-quarterly formulation is SALD formulation, developed in-house
utilizing Ascletis’ Ultra-Long-Acting Platform (ULAP) technology.
In head-to-head NHP studies, ASC36 SALD formulation demonstrated approximately 6-fold longer
observed half-life than eloralintide, supporting once-monthly to once-quarterly SQ administration
in humans.
ASC36 monotherapy demonstrated approximately 91% and 32% greater relative body weight
reduction compared to petrelintide and eloralintide monotherapies, respectively, in head-to-head DIO
rat studies.
Anticipated 2026 Milestone: Expected to announce topline pharmacokinetic data of ASC36 oncemonthly to once-quarterly SQ peptide by the end of 2026.
ASC36 oral peptide for obesity
During the Reporting Period and up to the date of this announcement, the Group has submitted an
IND application to the FDA for ASC36 oral tablets.
8
Utilizing Ascletis’ Peptide Oral Transport ENhancement Technology (POTENT), ASC36 oral tablets
achieved absolute oral bioavailability of 6% to 8% at steady state, in NHP studies.
In NHPs, ASC36 oral tablets reduced mean body weight up to 13.2% from baseline after oncedaily dosing for 7 days. ASC36 tablets also reduced food intake significantly.
ASC36 oral tablets are expected to utilize a lower dose due to potentially better oral bioavailability
and efficacy. This superior weight loss per milligram of ASC36 peptide may also provide
scalability advantages in manufacturing.
Anticipated 2026 Milestone: Expected to initiate Phase I trials of ASC36 oral peptide for the treatment
of obesity in the third quarter of 2026.
ASC35 once-monthly SQ peptide for obesity
During the Reporting Period and up to the date of this announcement, the Group has obtained the
IND clearance by the FDA and initiated the Phase I study of ASC35, a potentially best-in-class,
once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist, for the treatment
of obesity.
ASC35 once-monthly formulation is SALD formulation, developed in-house utilizing Ascletis’
Ultra-Long-Acting Platform (ULAP) technology. In head-to-head NHP studies, the average
observed half-life of ASC35 was approximately six-fold longer than tirzepatide, which supports
once-monthly SQ dosing in humans.
In a head-to-head DIO mouse study, ASC35 demonstrated approximately 71% greater relative body
weight reduction compared to tirzepatide.
Anticipated 2026 Milestone: Expected to announce topline pharmacokinetic data of ASC35 oncemonthly SQ peptide by the end of 2026.
ASC36_35FDC once-monthly SQ peptides for obesity
During the Reporting Period and up to the date of this announcement, the Group has obtained the
IND clearance by the FDA and initiated the Phase I study of ASC36_35FDC, a once-monthly SQ
fixed-dose combination injection of ASC36 and ASC35.
ASC36_35FDC once-monthly formulation is SALD formulation, developed in-house utilizing
Ascletis’ Ultra-Long-Acting Platform (ULAP) technology.
In NHP studies, ASC36_35FDC SALD co-formulation demonstrated long observed half-lives for
both ASC36 and ASC35, supporting once-monthly SQ administration in humans.
In head-to-head DIO rat studies, ASC36_35FDC, targeting three targets of amylin receptor, GLP1R and GIPR, demonstrated approximately 51% greater relative body weight reduction compared
to the co-administration of eloralintide and tirzepatide.
Anticipated 2027 Milestone: Expected to announce topline pharmacokinetic data of ASC36_35FDC
once-monthly SQ peptides at the beginning of the first quarter of 2027.
9
ASC37 once-monthly SQ peptide for obesity
During the Reporting Period and up to the date of this announcement, the Group has selected
ASC37 injection, a next-generation, once-monthly, subcutaneously administered GLP-1R/GIPR/
GCGR triple peptide agonist, as a clinical development candidate.
ASC37 was engineered to have 41 alpha amino acids, which qualifies it as a biologic. Biologics
license applications (BLAs) for ASC37 once-monthly SQ formulation will be submitted to the
FDA after completion of Phase III study.
ASC37 SQ SALD formulation had an average observed half-life of approximately 17 days compared
to 2.5 days for retatrutide. This approximately 7-fold longer half-life for ASC37 confirms oncemonthly or less dosing frequency.
ASC37 demonstrated statistically significant 88% greater relative body weight reduction compared
to tirzepatide in the DIO mouse model.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC37 injection
for the treatment of obesity in the third quarter of 2026.
ASC37 oral peptide for obesity
During the Reporting Period and up to the date of this announcement, the Group has continued the
development of ASC37 oral tablet.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC37 oral
tablet for the treatment of obesity in the third quarter of 2026.
ASC36_37FDC once-monthly SQ peptides for obesity
During the Reporting Period and up to the date of this announcement, the Group has selected
ASC36_37FDC, a once-monthly SQ GLP-1/GIP/GCG/amylin quadruple agonist fixed-dose
combination injection of ASC36 and ASC37.
Anticipated 2026 Milestone: Expected to submit an IND application to the FDA for ASC36_37FDC
injection for the treatment of obesity in the third quarter of 2026.
Although significant progress for its immune disease pipeline was made during the Reporting
Period and up to the date of this announcement, the Group has made a strategic decision to focus
on its metabolic disease pipeline and is seeking out-licensing opportunities for ASC50, ASC51 and
ASC52. This strategy will allow the Group to focus all of its resources on its metabolic disease
pipeline and have sufficient cash on hand to support its operations into 2029.
During the Reporting Period and up to the date of this announcement, the Group had positive
interactions with NMPA on denifanstat (ASC40) NDA for its moderate to severe acne indication.
The Group continues to work with NMPA with the goal to make denifanstat (ASC40) available to
patients. Denifanstat (ASC40)is licensed from Sagimet for the exclusive rights in Greater China.
10
Preclinical Discovery
Based on its three core discovery engines: (i) Artificial Intelligence-assisted Structure-Based Drug
Discovery (AISBDD); (ii) Ultra-Long-Acting Platform (ULAP); and (iii) Peptide Oral Transport
ENhancement Technology (POTENT), the Group continues to strengthen discovery efforts to
develop more pipeline assets of both small molecules and peptides with global best-in-class and
first-in-class competitiveness.
Cautionary statement required by Rules 18A.05 and 18A.08(3) of the Listing Rules: We
cannot guarantee that we will be able to ultimately develop, market and/or commercialize the drug
candidates in our pipeline successfully.
THE GROUP’S FACILITIES
The Group has manufacturing facilities located in Shaoxing, Zhejiang Province with a total gross
floor area of approximately 17,000 square meters. Our manufacturing facility is equipped with
state-of-the-art production equipment with cutting-edge technology capabilities such as hot-melt
extrusion and high-speed presses to ensure the high quality of our products.
As at June 30, 2026, the Group had 10 wholly-owned subsidiaries. The majority of the Group’s
business was conducted through Ascletis Pharma (China) in Hong Kong, while the minority of the
Group’s business was conducted through Ascletis BioScience and Ascletis Pharmaceuticals in
Chinese Mainland.
FUTURE AND OUTLOOK
The Group has established a comprehensive metabolic disease pipeline with key clinical stage
assets. The following are strategies and outlook for the second half of 2026:
1.
Expected to announce the topline data from the U.S. 13-week Phase II study of ASC30 oncedaily tablet for the treatment of diabetes in the third quarter of 2026;
2.
Expected to submit an IND application to the FDA for ASC39 oral tablets for the treatment
of obesity in the third quarter of 2026;
3.
Expected to submit an IND application to the FDA for ASC30_39FDC oral tablets for the
treatment of obesity in the third quarter of 2026;
4.
Expected to submit an IND application to the FDA for ASC30_48FDC oral tablets for the
treatment of obesity in the fourth quarter of 2026;
5.
Expected to submit an IND application to the FDA for ASC30_48_39FDC oral tablets for the
treatment of obesity in the fourth quarter of 2026;
6.
Expected to announce topline pharmacokinetic data of ASC36 once-monthly to once-quarterly
SQ peptide by the end of 2026;
11
7.
Expected to initiate Phase I trials of ASC36 oral peptide for the treatment of obesity in the
third quarter of 2026;
8.
Expected to announce topline pharmacokinetic data of ASC35 once-monthly SQ peptide by
the end of 2026;
9.
Expected to submit an IND application to the FDA for ASC37 injection for the treatment of
obesity in the third quarter of 2026;
10.
Expected to submit an IND application to the FDA for ASC37 oral tablet for the treatment of
obesity in the third quarter of 2026;
11.
Expected to submit an IND application to the FDA for ASC36_37FDC injection for the
treatment of obesity in the third quarter of 2026;
12.
Continue to strengthen early discovery efforts to develop more pipeline assets with global
best-in-class and first-in-class competitiveness;
13.
Seek license-out opportunities with global large pharma companies to maximize the value of
the Group; and
14.
The Group has sufficient cash on hand to support its operations into 2029, beyond the
expected submission of an NDA to the FDA and an MAA to EMA.
FINANCIAL REVIEW
Total income
The Group’s total income represents revenue, other income and gains. It decreased from approximately
RMB103.6 million for the six months ended June 30, 2025 to approximately RMB53.0 million for
the six months ended June 30, 2026, primarily due to a decline in one-off non-recurring income,
mainly from government grants for Chinese Mainland entities.
Other Income and Gains
The other income and gains of the Group decreased by 48.3% from approximately RMB102.5 million for
the six months ended June 30, 2025 to approximately RMB53.0 million for the six months ended
June 30, 2026, primarily because (i) a decrease in government grants for Chinese Mainland entities
from approximately RMB34.2 million for the six months ended June 30, 2025 to approximately
RMB1.2 million for the six months ended June 30, 2026; (ii) a decrease in net realized and
unrealized gains from equity investment from approximately RMB37.7 million for the six months
ended June 30, 2025 to approximately RMB17.3 million for the six months ended June 30, 2026.
The decrease was primarily attributable to a lower fair value gain on the Group’s investment in
Sagimet, which is measured at FVPL, as a result of the lower appreciation in Sagimet’s share price
during the Reporting Period compared with the corresponding period in 2025; and (iii) a significant
increase in foreign exchange loss from approximately RMB1.3 million for the six months ended
June 30, 2025 to approximately RMB10.1 million for the six months ended June 30, 2026, which
was offset by a significant increase in bank interest income from approximately RMB30.0 million
for the six months ended June 30, 2025 to RMB39.5 million for the six months ended June 30,
2026.
12
The following table sets forth the components of our other income and gains for the periods
indicated:
Unaudited
Six months ended June 30,
2026
2025
RMB ’000
RMB ’000
Bank interest income
Net realized and unrealized gains arising from
equity investment
Net realized and unrealized gains arising from wealth
management products and structured deposits
Net realized and unrealized gains on financial assets at FVOCI
Government grants
Foreign exchange loss, net
Others
Total
39,466
30,037
17,336
37,679
3,643
709
1,188
(10,110)
747
1,472
431
34,175
(1,308)
10
52,979
102,496
Administrative Expenses
The administrative expenses of the Group decreased by 28.9% from approximately RMB43.3
million for the six months ended June 30, 2025 to approximately RMB30.8 million for the six
months ended June 30, 2026, primarily due to the decrease in staff related costs.
Our administrative expenses primarily consisted of (i) staff salary and welfare costs for non-R&D
personnel; (ii) agency and consulting fees; and (iii) utilities, rent and general office expenses.
The following table sets forth the components of our administrative expenses for the periods indicated:
Unaudited
Six months ended June 30,
2026
2025
RMB ’000
%
RMB ’000
%
Staff salary and welfare
Agency and consulting fees
Utilities, rent and general office expenses
Others
12,612
13,959
4,092
140
40.9
45.3
13.3
0.5
20,517
17,548
4,897
340
47.4
40.5
11.3
0.8
Total
30,803
100.0
43,302
100.0
13
R&D Expenses
The Group’s R&D expenses primarily consisted of preclinical and clinical trial expenses, staff
costs and depreciation and amortization costs.
The R&D expenses of the Group increased by 132.7% from approximately RMB146.8 million for
the six months ended June 30, 2025 to approximately RMB341.7 million for the six months ended
June 30, 2026, primarily due to the Group’s increased investment in metabolic disease pipeline.
The Group ’ s increased investment in metabolic disease pipeline aligns with the significant
advancements made in this area.
Despite significant increase in R&D expenses, as at June 30, 2026, the Group had cash and cash
equivalents, time deposits, transferable certificates of deposit, structured deposits and wealth
management products of approximately RMB2,305.4 million (June 30, 2025: approximately
RMB1,827.9 million) to support its operations into 2029.
The following table sets forth the components of our R&D costs for the periods indicated:
Unaudited
Six months ended June 30,
2026
2025
RMB ’000
RMB ’000
Preclinical and clinical trial expenses
Staff costs
Depreciation and amortization costs
Others
268,394
55,812
7,657
9,800
75,897
60,796
5,553
4,566
Total
341,663
146,812
The following table sets forth the components of our R&D costs by product pipeline for the periods
indicated:
Unaudited
Six months ended June 30,
2026
2025
RMB ’000
RMB ’000
Metabolic diseases
Exploratory indications
Pre-clinical
145,777
14,506
181,380
42,640
66,149
38,023
Total
341,663
146,812
14
Finance Costs
The Group recorded approximately RMB0.1 million of finance costs for the six months ended June
30, 2026 due to the interest on the lease liabilities (June 30, 2025: approximately RMB0.1 million).
Income Tax
The Group is subject to income tax on an entity basis on profits arising in or derived from the
jurisdictions in which members of the Group are domiciled and operated.
The Group calculated the income tax expense by using the tax rate that would be applicable to the
expected total annual earnings.
The Group recorded income tax of approximately RMB0.1 million for the six months ended June
30, 2026 (June 30, 2025: Nil).
Inventories
The inventories of the Group consisted of raw materials used in research and development. Our
inventories decreased by 37.6% from approximately RMB1.9 million as at December 31, 2025
to approximately RMB1.2 million as at June 30, 2026, mainly due to the strengthening of the
management of inventory.
The following table sets forth the inventory balances as of the dates indicated:
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Raw materials
1,169
1,874
Total
1,169
1,874
Trade Receivables
The Group’s trade receivables decreased from approximately RMB0.2 million as at December 31,
2025 to nil as at June 30, 2026.
The following table sets forth the trade receivables balances as of the dates indicated:
15
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Trade receivables
–
223
Total
–
223
The Group’s trading terms with its customers are mainly on credit. The credit period is generally
from 30 days to 90 days. The Group seeks to maintain strict control over its outstanding
receivables and overdue balances are regularly reviewed by senior management. Trade receivables
are non-interest-bearing.
An aging analysis of the trade receivables as at the dates indicated, based on the invoice date and
net of loss allowance, is as follows:
Within 3 months
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
–
223
–
223
Prepayments, Other Receivables and Other Assets
The following table sets forth the components of prepayment, other receivables and other assets as
at the dates indicated:
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Value-added tax recoverable
Deposits and other receivables
Prepayments
Prepaid expenses
17,362
4,122
3,478
1,250
9,940
3,056
3,544
1,207
Total
26,212
17,747
16
Our value-added tax recoverable represented value-added tax (“VAT”) that can be carried forward
for future offset against output VAT or refunded by the relevant tax authorities. Our value-added
tax recoverable increased by 74.7% from approximately RMB9.9 million as at December 31, 2025
to approximately RMB17.4 million as at June 30, 2026, primarily due to the increase in input VAT
arising from higher R&D expenditures during the Reporting Period.
Deposits and other receivables are miscellaneous expenses including rental and other deposits.
Our prepayments primarily relate to purchases of clinical trial services, amounting to approximately
RMB3.5 million for the six months ended June 30, 2026 (June 30, 2025: approximately RMB3.5
million).
Prepayments to suppliers as at June 30, 2026 are due within one year.
As at June 30, 2026, no impairment losses were provided for the Group’s prepayments, other
receivables and other assets.
Financial Assets at Fair Value through Profit and Loss – non-current
The non-current portion of financial assets at FVPL of the Group, which primarily comprised the
Group’s investment in NASDAQ-listed shares of Sagimet, increased from RMB56.4 million as at
December 31, 2025 to approximately RMB68.7 million as at June 30, 2026, primarily due to the
appreciation in Sagimet’s quoted share price during the period.
Financial Assets at Fair Value through Profit and Loss – current
The current portion of financial assets at FVPL of the Group decreased from approximately
RMB26.1 million as at December 31, 2025 to approximately RMB24.9 million as at June 30, 2026,
primarily due to decreased investment in wealth management products.
Cash and Bank Balances
The following table sets forth the components of the Group’s time deposits and cash and cash
equivalents as at the dates indicated:
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Time deposits
Cash and cash equivalents
1,616,939
593,371
431,259
1,443,513
Total
2,210,310
1,874,772
17
Time deposits with original maturity over three months are made for varying periods depending
on our immediate cash requirements, and earn interest at the respective time deposit rates. Cash
and cash equivalents and time deposits earn interest at floating rates based on daily bank deposit
rates and the respective time deposit rates. The cash and cash equivalents and time deposits are
deposited with creditworthy banks with no recent history of default.
Trade Payables
Trade payables of the Group primarily consisted of payments to raw materials suppliers. The
following table sets forth the component of trade payables as at the dates indicated:
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Trade payables
14,623
1,344
Total
14,623
1,344
The following table sets forth an ageing analysis of the trade payables as at the dates indicated,
which is based on invoice date:
Within 3 months
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
14,623
1,344
Other Payables and Accruals
The following table sets forth the components of other payables and accruals outstanding as at the
dates indicated:
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Accrued expenses
Other payables
Payroll payable
Provisions
Taxes other than income tax
101,785
36,569
16,577
4,038
217
69,375
30,630
17,217
4,038
529
Total
159,186
121,789
18
The accrued expenses as at June 30, 2026 mainly represented the accrued R&D expenses actually
incurred but not yet invoiced. The accrued expenses increased from approximately RMB69.4
million as at December 31, 2025 to approximately RMB101.8 million as at June 30, 2026. The
accrued expenses are non-interest-bearing and due within one year.
Our other payables remained relatively stable and increased from approximately RMB30.6 million
as at December 31, 2025 to approximately RMB36.6 million as at June 30, 2026.
The payroll payable represented the accrued salary and bonus for the first half of 2026, which are
due within one year. The decrease in our payroll payable from approximately RMB17.2 million as
at December 31, 2025 to approximately RMB16.6 million as at June 30, 2026 was primarily due to
the decreased accrued salary and bonus.
The provisions remained unchanged at approximately RMB4.0 million as at both December 31,
2025, and June 30, 2026.
Deferred Income
The deferred income of the Group represented the unamortised portion of government grants
received in the Group’s Chinese Mainland subsidiaries to compensate such entities for the cost of
assets, which is subsequently recognised as income in profit or loss over the useful lives of the
relevant assets. The following table sets forth the deferred income as of the dates indicated:
As at
June 30,
2026
(Unaudited)
RMB ’000
As at
December 31,
2025
(Audited)
RMB ’000
Government grants
– Current
– Non-current
1,588
1,588
1,588
2,382
Total
3,176
3,970
Liquidity and Capital Resources
The primary uses of cash of the Group are to fund its R&D activities, purchase of equipment
and raw materials and other recurring expenses. During the Reporting Period, the Group funded
its working capital and other capital expenditure requirements by the proceeds from the Global
Offering, top-up placing and placing under the general mandate.
19
The following table sets forth a condensed summary of the Group’s consolidated statement of
cash flows for the periods indicated and analysis of balances of cash and cash equivalents for the
periods indicated:
For the
For the
six months
six months
ended June 30, ended June 30,
2026
2025
(Unaudited)
(Unaudited)
RMB ’000
RMB ’000
Net cash used in operating activities
Net cash (used in)/generated from investing activities
Net cash generated from/(used in) financing activities
Net (decrease)/increase in cash and cash equivalents
Cash and cash equivalents at beginning of period
Effect of foreign exchange rate changes, net
Cash and cash equivalents at end of period
(327,349)
(1,192,401)
708,762
(810,988)
1,443,513
(39,154)
(172,990)
904,605
(14,485)
717,130
864,326
(1,116)
593,371
1,580,340
As at June 30, 2026, cash and cash equivalents were mainly denominated in Renminbi and United
States dollars.
Operating Activities
Our cash inflows from operating activities mainly consisted of trade receivables received from
customers and government grants, and to date, government grants received by the Group have
originated exclusively from Chinese Mainland entities and the Australian entity, with no such
grants received from Hong Kong entities. Our cash outflows for operating activities mainly
consisted of payment of R&D costs and administrative expenses.
For the six months ended June 30, 2026, we had net cash used in operating activities of approximately
RMB327.3 million, primarily as a result of operating loss before changes in working capital of
approximately RMB358.3 million. The changes in working capital were mainly due to payment of
R&D costs.
Investing Activities
Our cash used in investing activities mainly consisted of purchase of time deposits with original
maturity of over three months, purchase of property, plant and equipment, purchase of intangible
assets and purchase of financial assets at FVPL.
20
For the six months ended June 30, 2026, our net cash used in investing activities was approximately
RMB1,192.4 million, primarily due to the increase in time deposits with original maturity of over
three months of approximately RMB1,194.1 million.
Financing Activities
Our cash generated from financing activities primarily related to proceeds from placing new shares
under general mandate.
For the six months ended June 30, 2026, our net cash generated from financing activities was
approximately RMB708.8 million, primarily attributable to proceeds from placing new shares
under general mandate of approximately RMB742.3 million.
Capital Expenditures
The principal capital expenditures of the Group primarily consisted of the purchase of office
equipment and plant and machinery. The following table sets forth our net capital expenditures as
at the dates indicated:
June 30,
2026
(Unaudited)
RMB ’000
December 31,
2025
(Audited)
RMB ’000
Office equipment
Plant and machinery
9
1,224
872
468
Total
1,233
1,340
Our capital expenditures decreased by 8.0% from approximately RMB1.3 million as at December
31, 2025 to approximately RMB1.2 million as at June 30, 2026, primarily because we reduced the
purchase of the office equipment for laboratory renovation.
Significant Investments Held, Material Acquisitions and Disposals
Save as disclosed in this announcement, the Group did not have any significant investments required
to be disclosed under paragraph 32(4A) of Appendix D2 to the Listing Rules, and any material
acquisitions or disposals of subsidiaries and associate companies for the six months ended June 30,
2026.
Indebtedness
Borrowings, Charges of Assets and Guarantees
As at June 30, 2026, the Group did not have any outstanding mortgages, charges, debentures,
other issued debt capital, bank overdrafts, borrowings, liabilities under acceptance or other similar
indebtedness, any guarantees or other material contingent liabilities.
21
Contingent Liabilities
(a)
Viking case
On December 29, 2022, Viking Therapeutics, Inc. (“Viking”), a pharmaceutical company
in the United States, filed certain complaints against the Company, its founder Jinzi Jason
WU and certain subsidiaries of the Company in connection with the Group’s drug candidates
ASC41 and ASC43F. One complaint was made with the United States International Trade
Commission, Washington D.C. (the “ITC”) and another complaint was made with the United
States District Court, Southern District of California, (the “USDC”) San Diego Division, each
covering similar allegations.
The Company received initial determination and final judgment (together the “Judgment”)
from ITC on the complaint on October 4, 2024 and May 29, 2025. The Judgment, made
by an Administrative Law Judge of the ITC, found a violation of Section 337 of the Tariff
Act of 1930 (as amended) in the importation of the Company’s drug candidates ASC41 and
ASC43F into the United States. In addition, a monetary sanction of USD567,000 (equivalent
to approximately RMB4,038,000) was proposed due to certain procedural issues during the
investigation phase. The Company has made a provision for this monetary sanction in the
financial statements.
Regarding the complaint made with USDC, there has been no major progress since January
1, 2026, and the relevant investigation and litigation proceedings are ongoing. The Company
will vigorously defend against the complaint. Accordingly, the Group has not made any
provision for the allegations arising from the complaint made with USDC filed by Viking as
at June 30, 2026.
(b)
Arbitration case
In September 2025, Ascletis Pharmaceuticals became involved in an arbitration proceeding
initiated by a previous customer due to commercial contracts dispute on sales of certain
products.
The claimant seeks compensation in an aggregate amount around RMB25 million, comprising
(i) contract payments, (ii) interest on the alleged occupied funds, and (iii) arbitration and
legal fees.
As at the date of this announcement, the arbitration is ongoing and no ruling has been issued.
Based on the information currently available, the outcome of the arbitration and its potential
financial impact on the Group cannot be reliably estimated. As at June 30, 2026, the Group
has not made any provision for the arbitration.
Charges of Assets
As at June 30, 2026, the Group had no charge on its assets.
22
Contractual Commitments
We leased certain of our properties and warehouse under operating lease arrangements. Leases for
properties and warehouse are negotiated for terms ranging mainly from one to three years.
The Group had approximately RMB3.2 million of capital commitments as at June 30, 2026 and
approximately RMB0.6 million of capital commitments as at December 31, 2025.
Key Financial Ratios
The following table sets forth our key financial ratios as of the dates indicated:
Current ratio(1)
Quick ratio(2)
Gearing ratio(3)
As at
June 30,
2026
(Unaudited)
As at
December 31,
2025
(Audited)
12.9
12.9
7.4%
15.1
15.0
6.4%
Notes:
(1)
Current ratio represents current assets divided by current liabilities as of the same date.
(2)
Quick ratio represents current assets less inventories and divided by current liabilities as of the same date.
(3)
Gearing ratio represents total liabilities divided by total assets as of the same date and multiplied by 100%.
Our current ratio decreased from 15.1 as at December 31, 2025 to 12.9 as at June 30, 2026, and our
quick ratio decreased from 15.0 as at December 31, 2025 to 12.9 as at June 30, 2026, primarily due
to an increase in current liabilities.
Our gearing ratio increased from 6.4% as at December 31, 2025 to 7.4% as at June 30, 2026, primarily
due to an increase in current liabilities.
Foreign Exchange Risk
Foreign currency risk refers to the risk of loss resulting from changes in foreign currency exchange
rates. Fluctuations in exchange rates between Renminbi and other currencies in which our Group
conducts business may affect our financial condition and results of operation.
The Group mainly operates in the PRC and is exposed to foreign exchange risk arising from
various currency exposures, primarily with respect to the USD. Foreign exchange risk arises from
recognized assets and liabilities in foreign operations. The conversion of Renminbi from foreign
currencies, including the USD, has been based on rates set by the People’s Bank of China. The
Group seeks to limit its exposure to foreign currency risk by closely monitoring and minimizing
its net foreign currency position. During the Reporting Period, the Group did not enter into any
currency hedging transactions.
23
Employees and Remuneration Policies
The emoluments of the Directors and senior management of the Group are decided by the Board
with reference to the recommendation given by the Remuneration Committee, having regard to
the Group ’ s operating results, salaries paid by comparable companies, time commitment and
responsibilities and employment conditions of the Directors and senior management.
As at June 30, 2026, the Group had a total of 217 employees, most of which were located in the
PRC. Over 79.7% of our employees obtained a bachelor’s degree or higher. The table below sets
forth our Group’s employees by function as disclosed:
As at June 30, 2026
Numbers of
employees
% of total
Management
R&D
Manufacturing
Operations
3
149
32
33
1.4
68.7
14.7
15.2
Total
217
100.0
The Group’s total staff costs for the six months ended June 30, 2026 were approximately RMB68.4
million, compared to approximately RMB82.1 million for the six months ended June 30, 2025.
The Group recruits employees through recruitment websites, recruiters, internal referral and job
fairs. The Group conducts new employee training, as well as professional and compliance training
programs for employees.
The Group enters into employment contracts with employees to cover matters such as wages,
benefits and grounds for termination. The remuneration package of our employees includes salary
and bonus, which are generally determined by the qualifications, industry experience, position and
performance. The Group makes contributions to social insurance and housing provident funds for
our employees as required by the PRC laws and regulations.
The Group also has adopted the share schemes under Chapter 17 of the Listing Rules to provide
incentives to employees for their persistent devotion in achieving long-term growth of the Group.
24
CONSOLIDATED STATEMENT OF PROFIT OR LOSS
For the six months ended 30 June 2026 – unaudited
Note
Revenue
Cost of sales
3
Gross profit
4
Other income and gains
Research and development costs
Administrative expenses
Other expenses
Loss from operations
Finance costs
2026
RMB ’000
2025
RMB ’000
–
–
1,081
(960)
–
121
52,979
(341,663)
(30,803)
(12)
102,496
(146,812)
(43,302)
(367)
(319,499)
(87,864)
(74)
(87)
Loss before taxation
5
(319,573)
(87,951)
Income tax
6
(98)
–
Loss for the period
(319,671)
(87,951)
Attributable to:
Equity shareholders of the Company
(319,671)
(87,951)
RMB
(30.74) cents
RMB
(9.14) cents
Loss per share
7
Basic and diluted
25
CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE
INCOME
For the six months ended 30 June 2026 – unaudited
2026
RMB ’000
2025
RMB ’000
(319,671)
(87,951)
7,850
247
Items that will not be reclassified to profit or loss:
Exchange differences on translation of the Company’s
financial statements into presentation currency
(65,026)
(5,546)
Other comprehensive income for the period
(57,176)
(5,299)
Total comprehensive loss for the period
(376,847)
(93,250)
Attributable to:
Equity shareholders of the Company
(376,847)
(93,250)
Loss for the period
Other comprehensive income for the period (after tax)
Items that are or may be reclassified subsequently
to profit or loss:
Exchange differences on translation
of foreign operations
26
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
At 30 June 2026 – unaudited
30 June
2026
RMB ’000
31 December
2025
RMB ’000
8
35,362
39,625
9
177
4,926
9,383
259
7,077
10,285
38,007
31,733
68,687
376
56,367
460
156,918
145,806
1,169
–
24,897
26,212
32,164
593,371
1,874
223
26,103
17,747
–
1,443,513
1,616,939
431,259
2,294,752
1,920,719
14,623
159,186
2,240
1,588
1,344
121,789
2,871
1,588
177,637
127,592
Net current assets
2,117,115
1,793,127
Total assets less current liabilities
2,274,033
1,938,933
Note
Non-current assets
Property, plant and equipment
Advance payments for property, plant and
equipment
Right-of-use assets
Other intangible assets
Financial assets at fair value through other
comprehensive income (“FVOCI”)
Financial assets at fair value through profit
or loss (“FVPL”)
Long-term deferred expenditure
Current assets
Inventories
Trade receivables
Financial assets at FVPL
Prepayments, other receivables and other assets
Financial assets at FVOCI
Cash and cash equivalents
Time deposits with original maturity over
three months
10
Current liabilities
Trade payables
Other payables and accruals
Lease liabilities
Deferred income
11
27
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (CONTINUED)
At 30 June 2026 – unaudited
30 June
2026
RMB ’000
31 December
2025
RMB ’000
1,496
1,588
2,287
2,382
3,084
4,669
NET ASSETS
2,270,949
1,934,264
CAPITAL AND RESERVES
Share capital
Reserves
727
2,270,222
679
1,933,585
Total equity attributable to equity
shareholders of the Company
2,270,949
1,934,264
TOTAL EQUITY
2,270,949
1,934,264
Non-current liabilities
Lease liabilities
Deferred income
28
NOTES TO THE UNAUDITED INTERIM FINANCIAL REPORT
1.
CORPORATE INFORMATION
The Company is a limited liability company incorporated in the Cayman Islands on 25 February 2014. The
registered office address of the Company is located at 190 Elgin Avenue, George Town, Grand Cayman
KY1-9008, Cayman Islands. The principal place of business in Hong Kong of the Company is located at 40th
Floor, Dah Sing Financial Centre, No. 248 Queen’s Road East, Wanchai, Hong Kong.
The Company is an investment holding company. The Company’s subsidiaries are principally engaged in the
research and development of pharmaceutical products.
The shares of the Company were listed on the Main Board of the Stock Exchange of Hong Kong Limited (the
“Stock Exchange”) on 1 August 2018.
2.
BASIS OF PREPARATION AND CHANGES IN ACCOUNTING POLICIES AND DISCLOSURES
2.1
BASIS OF PREPARATION
This interim financial report has been prepared in accordance with the applicable disclosure provisions of the
Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited, including compliance
with Hong Kong Accounting Standard (“HKAS”) 34, Interim financial reporting , issued by the Hong Kong
Institute of Certified Public Accountants (“HKICPA”). It was authorised for issue on 31 August 2026.
The interim financial report has been prepared in accordance with the same accounting policies adopted in the
2025 annual financial statements, except for the accounting policy changes that are expected to be reflected in
the 2026 annual financial statements. Details of any changes in accounting policies are set out in Note 2.2.
The preparation of an interim financial report in conformity with HKAS 34 requires management to make
judgements, estimates, and assumptions that affect the application of policies and reported amounts of assets
and liabilities, income, and expenses on a year-to-date basis. Actual results may differ from these estimates.
This interim financial report contains condensed consolidated financial statements and selected explanatory
notes. The notes include an explanation of events and transactions that are significant to an understanding of
the changes in financial position and performance of the Group since the 2025 annual financial statements.
The condensed consolidated interim financial statements and the accompanying notes do not include all of the
information required for a full set of financial statements prepared in accordance with HKFRS Accounting
Standards.
The interim financial report is unaudited, but has been reviewed by KPMG in accordance with Hong Kong
Standard on Review Engagements 2410, Review of interim financial information performed by the independent
auditor of the entity , issued by the HKICPA.
2.2
CHANGES IN ACCOUNTING POLICIES AND DISCLOSURES
The HKICPA has issued a number of amendments to HKFRS Accounting Standards that are first effective for
the current accounting period, including:
•
Amendments to HKFRS 9, Financial instruments and HKFRS 7, Financial instruments: disclosures –
Contracts referencing nature dependent electricity
•
Amendments to HKFRS 9, Financial instruments and HKFRS 7, Financial instruments: disclosures –
Amendments to the classification and measurement of financial instruments
•
Annual improvements to HKFRSs – Volume 11
These amendments do not have a material financial impact on this interim report as the Group has not entered
into such transactions.
The Group has not applied any new standard or interpretation that is not yet effective for the current accounting
period.
29
3.
REVENUE AND SEGMENT REPORTING
(a)
Revenue
(i)
Disaggregation of revenue
Disaggregation of revenue from contracts with customers by products or service lines is as follows:
For the six months ended 30 June
2026
2025
RMB ’000
RMB ’000
Revenue from contracts with customers within
the scope of IFRS 15
(b)
Recognised over time:
– Provide R&D service
– Others
–
–
1,054
27
Total
–
1,081
Segment reporting
Operating segments are identified on the basis of internal reports that the Group’s most senior executive
management reviews regularly in allocating resources to segments and in assessing their performances.
The Group’s most senior executive management makes resources allocation decisions based on internal
management functions and assess the Group’s business performance as one integrated business instead
of by separate business lines or geographical regions. Accordingly, the Group has only one operating
segment and therefore, no segment information is presented.
(c)
Geographical information
The following table sets out information about the geographical location of (i) the Group’s revenue from
external customers and (ii) the Group’s property, plant and equipment and intangible assets (“specified
non-current assets”). The geographical location of customers is based on their operating location. The
geographical location of the specified non-current assets is based on the physical location of the asset, in
the case of property, plant and equipment, and the location of the operation to which they are allocated,
in the case of intangible assets.
(i)
Revenue from external customers
For the six months ended 30 June
2026
2025
RMB ’000
RMB ’000
(ii)
Hong Kong
Other region
–
–
1,054
27
Total
–
1,081
30 June
2026
RMB ’000
31 December
2025
RMB ’000
Chinese Mainland
United States
44,741
4
49,906
4
Total
44,745
49,910
Non-current assets
30
4.
OTHER INCOME AND GAINS
For the six months ended 30 June
2026
2025
RMB ’000
RMB ’000
Bank interest income
Net realized and unrealized gains arising from equity investment
Net realized and unrealized gains arising from wealth
management products and structured deposits
Net realized and unrealized gains on financial assets at FVOCI
Government grants (i)
Foreign exchange loss, net
Others
39,466
17,336
30,037
37,679
3,643
709
1,188
(10,110)
747
1,472
431
34,175
(1,308)
10
Total
52,979
102,496
Note:
(i)
5.
The government grants mainly represent subsidies received from the local governments for the purpose
of compensation for expenses arising from research activities, clinical trials and daily operating activities
and capital expenditure incurred on certain projects, and awarding the new drug development.
LOSS BEFORE TAX
The Group’s loss before tax is arrived at after charging/(crediting):
(a)
Finance cost
For the six months ended 30 June
2026
2025
RMB ’000
RMB ’000
74
Interest on lease liabilities
(b)
87
Other items
For the six months ended 30 June
2026
2025
RMB ’000
RMB ’000
Depreciation of items of property, plant and equipment
Depreciation of right-of-use assets
Amortisation of intangible assets
Write-down of inventories to net realisable value
Auditor’s remuneration
Lawsuit expenses
Equity-settled share award and option expense
6.
5,469
2,151
953
16
551
836
3,274
5,470
2,756
1,214
23
551
1,899
3,836
INCOME TAX
The Group is subject to income tax on an entity basis on profits arising in or derived from the jurisdictions in
which members of the Group are domiciled and operated.
Cayman Islands
Under the current laws of the Cayman Islands, the Company is not subject to tax on income or capital gains. In
addition, upon payments of dividends by the Company to its shareholders, no Cayman Islands withholding tax is
imposed.
31
British Virgin Islands
Under the current laws of the British Virgin Islands (“BVI”), PowerTree Investment (BVI) Ltd. (“PowerTree”)
is not subject to tax on income or capital gains. In addition, upon payments of dividends by PowerTree to its
shareholder, no BVI withholding tax is imposed.
Hong Kong
Under the current laws of Hong Kong, the subsidiary in Hong Kong is subject to profits tax at a rate of 16.5%
(2025: 16.5%) on the estimated assessable profits arising in Hong Kong. During the reporting period, no
provision for profits tax has been made as the subsidiary did not generate any assessable profits in Hong Kong.
The United States
Under the current laws of the United States, the subsidiary in the United States is subject to tax at a maximum
of 21% (2025: 21%) federal corporate income tax rate and 2.5% (2025: 2.5%) North Carolina state tax rate.
During the reporting period, no provision for income tax has been made as the subsidiary did not generate any
assessable income in United States.
Australia
Under the current laws of Australia, the subsidiary in the Australia is subject to profits tax at a rate of 30%
(2025: 30%). During the reporting period, no provision for income tax has been made as the subsidiary did not
generate any assessable income in Australia.
Chinese Mainland
Pursuant to the Corporate Income Tax Law of the PRC and the respective regulations (the “CIT Law”), the
subsidiaries which operate in Chinese Mainland are subject to CIT at a rate of 25% (2025: 25%) on the taxable
income.
Pursuant to the CIT Law, non-resident enterprises without an establishment or place of business in the PRC
or which have an establishment or place of business in the PRC but whose relevant income is not effectively
connected with the establishment or a place of business in the PRC, will be subject to withholding tax at the rate
of 10% (unless reduced by treaty) on various types of passive income such as dividends derived from sources
within the PRC.
Preferential tax treatment is available to Ascletis Pharmaceuticals Co., Ltd. (“Ascletis Pharmaceuticals”) (歌禮
藥業(浙江)有限公司) since it was recognised as a High and New Technology Enterprise, and it was entitled to
a preferential tax rate of 15% (2025: 15%) during the reporting period.
Certain subsidiaries in the PRC were entitled to a preferential PRC CIT rate of 5% as they were accredited as
small and micro business.
According to the new tax incentive policies promulgated by the State Taxation Administration of the PRC in
March 2023, effective from 1 January 2023, an additional 100% of qualified research and development expenses
incurred is allowed to be deducted from taxable income.
7.
LOSS PER SHARE
The calculation of basic loss per share is based on the loss attributable to ordinary equity shareholders of the
Company of RMB319,671,000 (six months ended 30 June, 2025: RMB87,951,000) and the weighted average
of 1,039,794,415 ordinary shares (six months ended 30 June, 2025: 962,522,870) in issue during the interim
period.
No adjustment has been made to the basic loss per share amounts presented for the periods ended 30 June, 2026
and 2025 in respect of a dilution as the impact of the share award and options had an anti-dilutive effect on the
basic loss per share amounts presented.
32
8.
PROPERTY, PLANT AND EQUIPMENT
During the six months ended 30 June, 2026, the Group acquired assets at a cost of RMB1,233,000 (six months
ended 30 June, 2025: RMB1,072,000).
Items of plant and machinery with a net book value of RMB9,000 were disposed of during the six months ended
30 June, 2026 (six months ended 30 June, 2025: RMB50,000), resulting in a loss on disposal of RMB9,000 (six
months ended 30 June, 2025: RMB50,000).
9.
RIGHT-OF-USE ASSETS
During the six months ended 30 June, 2026, the Group did not enter into any new office occupancy lease
agreements, and therefore no additions to right-of-use assets were recognised in the period (six months ended 30
June, 2025: RMB2,121,000).
10.
TRADE RECEIVABLES
As of the end of the reporting period, the ageing analysis of the trade receivables, based on the invoice date and
net of loss allowance, is as follows:
Within 3 months
11.
30 June
2026
RMB ’000
31 December
2025
RMB ’000
–
223
TRADE PAYABLES
As of the end of the reporting period, the ageing analysis of the trade payables, based on the invoice date, is as
follows:
Within 3 months
12.
30 June
2026
RMB ’000
31 December
2025
RMB ’000
14,623
1,344
CAPITAL, RESERVES AND DIVIDENDS
(a)
Dividends
The board of directors does not recommend the payment of any dividend in respect of the six months
ended 30 June, 2026 (six months ended 30 June, 2025: nil).
(b)
Share capital
(i)
Issued share capital
2026
No. of shares
Ordinary shares, issued and fully paid:
At 1 January
Shares cancelled
Issuance of shares
At 30 June
RMB ’000
2025
No. of shares
RMB ’000
998,958,530
–
69,496,525
679
–
48
1,012,758,000
(44,896,790)
1,569,285
689
(32)
1
1,068,455,055
727
969,430,495
658
The par value of the ordinary shares of the Company is US$0.0001 each.
33
(ii)
Repurchase of own shares
During the interim period, the Company repurchased its own shares on the Stock Exchange as follows:
Month/year
Number
of shares
repurchased
Highest
price paid
per share
HKD
Lowest
price paid
per share
HKD
Aggregate price
paid (including
transaction fee)
HKD ’000
June 2026
3,745,000
10.77
9.14
37,300
The total amount paid on the repurchased shares of HKD37,300,000 (equivalent to RMB32,438,000) was
fully paid.
(iii)
Cancellation of share repurchased
During the six months ended 30 June, 2026, the Company did not cancel any repurchased shares (six
months ended 30 June, 2025: 44,896,790 shares).
(iv)
Shares issued under share option scheme
During the six months ended 30 June, 2026, options were exercised to subscribe for 240,525 (six months
ended 30 June, 2025: 1,569,285) ordinary shares in the Company at a consideration of RMB371,000 (six
months ended 30 June, 2025: RMB3,849,000). Less than RMB1,000 (six months ended 30 June, 2025:
RMB1,000) was credited to share capital and an amount of RMB371,000 (six months ended 30 June,
2025: RMB3,848,000) was credited to capital reserve.
(v)
Placement of new shares
On 10 February 2026, the Company successfully allotted and issued a total of 69,256,000 new shares
(the “Placing Shares”) to not less than six placees who and whose ultimate beneficial owners are third
parties independent of and not connected with the Company, connected persons of the Company and any
of the directors, supervisors, chief executive or substantial shareholder(s) of the Company or any of its
subsidiaries or their respective associates at a placing price of HK$12.18 per Placing Share. The Placing
Shares represented approximately 6.53% of the total number of issued shares as enlarged by the allotment
and issue of the Placing Shares. The net proceeds (after deduction of the commissions and estimated
expenses) from the placing were approximately HK$835.2 million (equivalent to RMB742.3 million). For
more details, please refer to the announcement of the Company dated 10 February 2026.
(c)
Equity settled share-based transactions
On 3 February 2025, the Company adopted a share option scheme (the “2025 Share Option Scheme”)
and a share award scheme (the “2025 Share Award Scheme”). The purpose of these schemes is to
reward directors and employees for their service to the Group and to provide incentives to them to further
contribute to the Group.
Each option gives the holder the right to subscribe for one ordinary share of the Company. These share
options will vest from 14 January 2026 to 14 January 2029, and then be exercisable until 2035. The share
awards will vest conditional upon the fulfilment of the specific performance targets.
During the six months ended 30 June, 2026, no share options or share awards were granted by the
Company (six months ended 30 June, 2025: 4,820,175 share options and 5,784,210 share awards).
34
13.
CONTINGENT LIABILITIES
(a)
Viking case
On 29 December 2022, Viking Therapeutics, Inc. (“Viking”), a pharmaceutical company in the United
States, filed certain complaints against the Company, its founder Jinzi Jason WU and certain subsidiaries
of the Company in connection with the Group’s drug candidates ASC41 and ASC43F. One complaint was
made with the United States International Trade Commission, Washington D.C. (the “ITC”) and another
complaint was made with the United States District Court, Southern District of California, (the “USDC”)
San Diego Division, each covering similar allegations.
The Company received initial determination and final judgment (together the “Judgment”) from ITC on
the complaint on 4 October 2024 and 29 May 2025. The Judgment, made by an Administrative Law Judge
of the ITC, found a violation of Section 337 of the Tariff Act of 1930 (as amended) in the importation
of the Company’s drug candidates ASC41 and ASC43F into the United States. In addition, a monetary
sanction of USD567,000 (equivalent to approximately RMB4,038,000) was proposed due to certain
procedural issues during the investigation phase. The Company has made a provision for this monetary
sanction in the financial statements.
Regarding the complaint made with USDC, there has been no major progress since 1 January 2026, and
the relevant investigation and litigation proceedings are ongoing. The Company will vigorously defend
against the complaint. Accordingly, the Group has not made any provision for the allegations arising from
the compliant made with USDC filed by Viking as at 30 June, 2026.
(b)
Arbitration case
In September 2025, Ascletis Pharmaceuticals became involved in an arbitration proceeding initiated by a
previous customer due to commercial contracts dispute on sales of certain products.
The claimant seeks compensation in an aggregate amount around RMB25 million, comprising (i) contract
payments, (ii) interest on the alleged occupied funds, and (iii) arbitration and legal fees.
As at the date of this announcement, the arbitration is ongoing and no ruling has been issued. Based on
the information currently available, the outcome of the arbitration and its potential financial impact on
the Group cannot be reliably estimated. As at 30 June, 2026, the Group has not made any provision for
the arbitration.
35
COMPLIANCE WITH THE CORPORATE GOVERNANCE CODE
The Company is committed to maintaining high standard of corporate governance to safeguard
the interests of the Shareholders, enhance corporate value, formulate its business strategies and
policies, and enhance its transparency and accountability.
The Company has adopted the code provisions of the CG Code as set out in Appendix C1 to the
Listing Rules as its own code of corporate governance.
The Board is of the view that the Company has complied with all applicable code provisions of the
CG Code during the Reporting Period, except for a deviation from the code provision C.2.1 of part
2 of the CG Code, the roles of chairman of the Board and chief executive officer of the Company
are not separate and are both performed by Dr. Wu. The Company is an investment holding
company with a professional management team to monitor the operations of the subsidiaries. The
Board considers that vesting the roles of chairman of the Board and chief executive officer in
the same person is more efficient in the direction and management of the Company and does not
impair the balance of power and authority of the Board and the management of the business of the
Company. The Board will review the corporate governance structure and practices from time to
time and shall make necessary arrangements when the Board considers appropriate.
COMPLIANCE WITH THE MODEL CODE FOR SECURITIES TRANSACTIONS
The Company has adopted the Written Guidelines on no less exacting terms than the Model Code
as its own code of conduct regarding securities transactions by the Directors.
Having made specific enquiry of all Directors, all of them have confirmed that they have complied
with the Model Code and the Written Guidelines throughout the Reporting Period and up to the
date of this announcement. No incident of non-compliance with the Written Guidelines by the
employees who are likely to be in possession of inside information of the Company was noted by
the Company during the Reporting Period.
PURCHASE, SALE OR REDEMPTION OF THE LISTED SECURITIES OF THE
COMPANY
The Company repurchases Shares from time to time for the purposes of enhancing shareholder
value in the long term and providing greater flexibility to the Board to resell the treasury shares
at prevailing market prices to raise additional funds for the Company, transfer or use the treasury
shares for share grants under share schemes that comply with Chapter 17 of the Listing Rules,
or use them for other purposes permitted under the Listing Rules, the Articles and the applicable
laws of the Cayman Islands. During the Reporting Period, the Company repurchased a total of 3,745,000
Shares on the Stock Exchange at an aggregate consideration of HK$37,227,010, mainly for the purpose
of enhancing the value of the Shares and thereby benefiting the Shareholders as a whole. During
the Reporting Period and up to the date of this announcement, the Company repurchased a total
of 5,745,000 Shares of the Company on the Stock Exchange at an aggregate consideration of
HK$55,954,050. As at the date of this announcement, 9,386,000 ordinary Shares repurchased for
cancellation and 1,300,000 treasury Shares have been cancelled and the total number of Shares in
issue has been reduced accordingly as at the date of this announcement.
Particulars of the Shares repurchased during the Reporting Period and up to the date of this
announcement are as follows:
36
Trading Month
Number and Method of
Shares Repurchased
June 2026
July 2026
3,745,000 on the Stock Exchange
2,000,000 on the Stock Exchange
Total
5,745,000
Price Per Share
Lowest
Highest
price paid
price paid
per Share
per Share
(HK$)
(HK$)
10.77
11.67
9.14
8.01
Aggregate
Consideration
Paid
(HK$)
37,227,010.00
18,727,040.00
55,954,050.00
Save for the above, during the Reporting Period and up to the date of this announcement, neither
the Company nor any of its subsidiaries has purchased, sold or redeemed any of the Company’s
listed securities (including sale of treasury shares).
As at June 30, 2026, for the purpose of the Listing Rules, the Company held 7,084,210 treasury
shares and such treasury shares are used for the share schemes of the Company, including the 2025
Share Award Scheme. For details, please refer to the announcement and circular of the Company
dated January 14, 2025 and January 15, 2025 respectively, and the poll results announcement of
the extraordinary general meeting of the Company dated February 3, 2025.
CHANGES IN DIRECTORS’ INFORMATION
During the Reporting Period, the Board has not been informed of any change in the Directors’
information required to be disclosed pursuant to Rule 13.51B(1) of the Listing Rules.
REVIEW OF INTERIM RESULTS
The independent auditor of the Company, namely, KPMG, has carried out a review of the interim
financial information in accordance with the Hong Kong Standard on Review Engagements 2410,
“Review of Interim Financial Information Performed by the Independent Auditor of the Entity”
issued by the Hong Kong Institute of Certified Public Accountants.
The Audit Committee comprises three independent non-executive Directors, namely, Mr. Jiong
GU, Dr. Yizhen WEI, and Ms. Lin HUA. The chairman of the Audit Committee is Mr. Jiong GU.
The Audit Committee has jointly reviewed with the management the accounting principles and
policies adopted by the Company 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. The Audit Committee considered that the interim results are in compliance with the
applicable accounting standards, laws and regulations, and the Company has made appropriate
disclosures thereof. There were no disagreements between the Board and the Audit Committee
regarding the selection, application and interpretation of accounting standards, the accounting
treatment adopted by the Company, or the interim financial information prepared and presented by
the management during the Reporting Period.
EVENTS AFTER THE REPORTING PERIOD
There are no significant subsequent events after the Reporting Period and up to the date of this
announcement.
37
INTERIM DIVIDEND
The Board does not recommend payment of an interim dividend for the six months ended June 30,
2026.
PUBLICATION OF INTERIM RESULTS AND INTERIM REPORT
This announcement is published on the website of the Stock Exchange (www.hkexnews.hk) and
the Company’s website (www.ascletis.com). The interim report for the six months ended June 30,
2026 containing all the information in accordance with the requirements under the Listing Rules
will be dispatched to the Shareholders who request printed copies and published on the respective
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.
38
DEFINITIONS
“2025 Share Option Scheme”
the 2025 Share Option Scheme adopted by the Company on
February 3, 2025
“2025 Share Award Scheme”
the 2025 Share Award Scheme adopted by the Company on
February 3, 2025
“Articles”
the articles of association of the Company
“Ascletis”, “Company”, “the
Company” or “We”
Ascletis Pharma Inc. (歌禮製藥有限公司), an exempted company
incorporated in the Cayman Islands with limited liability on
February 25, 2014
“Ascletis BioScience”
Ascletis BioScience Co., Ltd. (歌禮生物科技(杭州)有限公司),
a limited liability company established in the PRC on April 26,
2013 and an indirectly wholly-owned subsidiary of the Company
“Ascletis Pharma (China)”
Ascletis Pharma (China) Co., Limited (歌禮製藥(中國)有限公
司), a company incorporated in Hong Kong with limited liability
on March 15, 2018 and an indirectly wholly-owned subsidiary of
the Company
“Ascletis Pharmaceuticals”
Ascletis Pharmaceuticals Co., Ltd. (歌禮藥業(浙江)有限公司),
a limited liability company established in the PRC on September
24, 2014 and an indirectly wholly-owned subsidiary of the
Company
“Audit Committee”
the audit committee of the Board
“Board” or “Board of
Directors”
the board of directors of the Company
“cAMP”
cyclic adenosine monophosphate
“CG Code”
the Corporate Governance Code as set out in Appendix C1 to the
Listing Rules
“Chairman”
the chairman of the Board
“China”, “Chinese Mainland”
or “the PRC”
the People’s Republic of China, excluding, for the purpose of this
announcement, Hong Kong, Macau Special Administrative Region
and Taiwan
“Director(s)”
the director(s) of the Company
“DIO”
diet-induced obese
“Dr. Wu”
Dr. Jinzi Jason WU (吳勁梓), the founder, chairman of the Board,
chief executive officer and one of the controlling shareholders of
the Company and the spouse of Mrs. Judy Hejingdao Wu
39
“EMA”
European Medicines Agency
“FASN”
fatty acid synthase
“FDA”
U.S. Food and Drug Administration
“FDC”
fixed-dose combination
“FVOCI”
fair value through other comprehensive income
“FVPL”
fair value through profit or loss
“GCGR”
glucagon receptor
“GIPR”
gastric inhibitory polypeptide receptor
“GLP-1R”
glucagon-like peptide 1 receptor
“Group”, “our Group” or
“the Group”
the Company and its subsidiaries
“hAMY1R”
human amylin 1 receptor
“hCTR”
human calcitonin receptor
“HK$” or “HKD”
Hong Kong dollars, the lawful currency of Hong Kong
“Hong Kong”
the Hong Kong Special Administrative Region of the PRC
“IL-17A and F”
interleukin-17A and F
“IND(s)”
investigational new drug(s), (an) experimental drug for which
a pharmaceutical company obtains permission to ship across
jurisdictions (usually to clinical investigators) before a marketing
application for the drug has been approved
“Listing Rules”
the Rules Governing the Listing of Securities on the Stock
Exchange, as amended or supplemented from time to time
“MAA”
Marketing Authorisation Application
“Main Board”
the Main Board of the Stock Exchange
“Model Code”
the Model Code for Securities Transactions by Directors of Listed
Issuers contained in Appendix C3 to the Listing Rules
“NDA”
New Drug Application
“NHP(s)”
non-human primate
40
“NMPA”
China National Medical Products Administration
“Option(s)”
share option(s) granted to a grantee to subscribe for Shares
pursuant to the terms of the 2025 Share Option Scheme
“QD”
once daily
“R&D”
research and development
“Renminbi” or “RMB”
Renminbi Yuan, the lawful currency of China
“Reporting Period”
the six-month period from January 1, 2026 to June 30, 2026
“SAD”
single ascending dose
“Sagimet”
Sagimet Biosciences Inc., a corporation incorporated in Delaware
in December 2006, whose shares are listed on the Nasdaq Stock
Market (stock code: SGMT)
“SALD”
Self-Assembling Lipid Depot
“Share(s)”
ordinary shares in the share capital of our Company of US$0.0001
each
“Share Award(s)”
Share award(s) granted to a Grantee to subscribe for Shares
pursuant to the terms of the 2025 Share Award Scheme
“Shareholder(s)”
holder(s) of Shares
“SQ”
subcutaneous
“STAT6”
Signal Transducer and Activator of Transcription 6
“Stock Exchange”
The Stock Exchange of Hong Kong Limited
“U.S.”
United States of America
“USD” or “US$”
United States dollars, the lawful currency of the United States of
America
“vs.”
versus
“Written Guidelines”
the Guidelines for Securities Transactions by Directors adopted
by the Company
“%”
per cent
41
In this announcement, the terms “associate ”, “connected person ”, “controlling shareholder ” and
“subsidiary ” shall have the meanings given to such terms in the Listing Rules, unless the context
otherwise requires.
By order of the Board
Ascletis Pharma Inc.
歌禮製藥有限公司
Jinzi Jason WU
Chairman
Hong Kong
August 31, 2026
As at the date of this announcement, the Board comprises Dr. Jinzi Jason WU and Mrs. Judy
Hejingdao WU, as executive Directors; and Dr. Yizhen WEI, Mr. Jiong GU and Ms. Lin HUA, as
independent non-executive Directors.
42
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,概不就因本公告全部或任何部分內容所產生或因依
賴該等內容而引致的任何損失承擔任何責任。
本公告載有涉及風險及不確定因素的前瞻性陳述。除過往事實陳述以外的所有陳述均為前瞻性
陳述。該等陳述涉及已知及未知風險、不確定因素及其他因素,當中若干風險及因素並非本公
司所能控制,其可導致實際業績、表現或成果與該等前瞻性陳述所明示或暗示者存在重大差
異。 閣下不應依賴前瞻性陳述作為未來事件的預測。本公司概不承擔更新或修訂任何前瞻性
陳述的責任,無論是否由於新資料、未來事件或其他因素所致。
Ascletis Pharma Inc.
歌禮製藥有限公司
(於開曼群島註冊成立的有限公司)
股份代號:1672
截至二零二六年六月三十日止六個月之中期業績公告
董事會謹此宣佈,本集團截至二零二六年六月三十日止六個月之未經審核綜合中
期業績連同二零二五年同期之比較數據如下。
財務概要
未經審核
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)
收入總額 (1)
研發成本
行政開支
其他開支
融資成本
除稅前虧損
所得稅
期內虧損
以下人士應佔:
本公司權益股東
每股虧損
基本及攤薄
附註:
(1)
本集團收入總額為收入、其他收入及收益。
1
變動
%
52,979
(341,663)
(30,803)
(12)
(74)
(319,573)
(98)
(319,671)
103,577
(146,812)
(43,302)
(367)
(87)
(87,951)
–
(87,951)
(48.9)
132.7
(28.9)
(96.7)
(14.9)
263.4
–
263.5
(319,671)
(87,951)
263.5
人民幣
人民幣
(30.74)分
(9.14)分
公司簡介
我們的願景
歌禮的願景是成為最具創新力的世界級生物醫藥公司,致力於解決代謝疾病尚未
被滿足的全球醫療需求。
概覽
於報告期內及直至本公告日期,本集團在代謝性疾病管線方面取得重大進展:
(i)
已針對ASC30長期體重管理適應症啟動了一項全球III期臨床項目,該項目由
兩項關鍵的多中心、隨機、雙盲、安慰劑對照的全球III期試驗(AURORA-1
和AURORA-2)組成,將在美國、歐洲和加拿大共入組約4,600名肥胖或超重
受試者。近期,ASC30用於長期體重管理的全球III期臨床項目已完成首例受
試者給藥。本集團預計將於二零二八年第三季度公佈ASC30 III期臨床項目
的頂線數據,預計將於二零二八年末前向FDA提交NDA,並預計將於二零
二九年初向EMA提交MAA。本集團擁有充足的在手現金,除覆蓋預計提交
的ASC30 NDA及MAA外,可支持運營至二零二九年。
(ii)
正在為期13週的美國II期研究中評估治療糖尿病的ASC30小分子GLP-1每日
一次口服片。預計將於二零二六年第三季度獲得頂線數據。
(iii) ASC39(一款潛在同類首創、與eloralintide類似的每日一次口服小分子胰淀
素選擇性受體激動劑(SARA))在臨床前模型中顯示出與eloralintide相似的胰
淀素選擇性與療效,預計將於二零二六年第三季度向FDA遞交ASC39口服片
的IND申請。
(iv) ASC30_39FDC(一款ASC30與ASC39的固定劑量複方製劑)已獲選定為臨床
開發候選藥物,預計將於二零二六年第三季度向FDA遞交ASC30_39FDC口
服片的IND申請。
(v)
ASC30_48FDC(一款ASC30與ASC48(一款潛在同類首創口服小分子GIPR
激動劑)的固定劑量複方製劑)已獲選定為臨床開發候選藥物,預計將於二
零二六年第四季度向FDA遞交ASC30_48FDC口服片的IND申請。
(vi) ASC30_48_39FDC(一款ASC30、ASC48與ASC39的固定劑量複方製劑)已獲選
定進行臨床開發,預計將於二零二六年第四季度向FDA遞交ASC30_48_39FDC
口服片的IND申請。
(vii) ASC36(一款治療肥胖症的每月一次至每季度一次、潛在同類最佳皮下注射
胰淀素受體激動劑)已獲得FDA的IND批准,預計將於二零二六年末前公佈
頂線藥代動力學數據。
(viii) ASC36 口服片(本公司首款口服胰淀素受體激動劑多肽)已向FDA遞交IND
申請,預計將於二零二六年第三季度啟動I期試驗。
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(ix) ASC35(一款治療肥胖症的潛在同類最佳、每月一次皮下注射GLP-1R/GIPR
雙靶點激動劑多肽)已獲得FDA的IND批准,預計將於二零二六年末前公佈
頂線藥代動力學數據。
(x)
ASC36_35FDC(一款ASC36 與ASC35 的固定劑量複方製劑)已獲得FDA的
IND批准,預計將於二零二七年第一季度初公佈頂線藥代動力學數據。
(xi) ASC37注射劑(一款新一代每月一次皮下注射GLP-1R/GIPR/GCGR三靶點激
動劑多肽)已獲選定為臨床開發候選藥物,預計將於二零二六年第三季度向
FDA遞交ASC37注射劑的IND申請。
(xii) ASC37口服片已獲選定為臨床開發候選藥物,預計將於二零二六年第三季度
向FDA遞交ASC37口服片的IND申請。
(xiii) ASC36_37FDC(一款ASC36與ASC37的固定劑量複方製劑)已獲選定進行臨
床開發,預計將於二零二六年第三季度向FDA遞交ASC36_37FDC注射劑的
IND申請。
於報告期內及直至本公告日期,本集團在免疫性疾病管線方面取得重大進展:
(i)
ASC50為一款IL-17A口服小分子抑制劑,已完成健康受試者美國I期SAD研
究及輕度至中度斑塊狀銀屑病患者為期28 天的美國I期概念驗證研究(POC)
(200 mg QD)。人體數據表明,ASC50有望成為同類首創及同類最佳口服小
分子IL-17A抑制劑。
(ii)
ASC51 為一款強效、選擇性及每日一次口服STAT6 降解劑並已具備向FDA
提交IND申請條件的候選藥物。ASC51已完成FDA IND所需的全部準備研
究,並有望成為繼KT-62後同類第二款STAT6口服小分子降解劑。
(iii) ASC52有望成為同類最佳IL-17AA、AF及FF口服環肽拮抗劑,預計將於二
零二六年第四季度向FDA遞交IND。ASC52有望成為繼PN-881後同類第二
款IL-17AA、AF及FF口服環肽拮抗劑。
該等成就凸顯本集團強大的研發能力、卓越的執行力以及研發全球同類最佳 ╱ 全
球同類首創管線藥物以解決未被滿足臨床需求的長期承諾。
於二零二六年六月三十日,本集團現金及現金等價物、定期存款、可轉讓存單、
結構性存款及理財產品約為人民幣2,305.4百萬元(二零二五年六月三十日:約人
民幣1,827.9百萬元),可支持其運營直至二零二九年。
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本集團的研發成本由截至二零二五年六月三十日止六個月的約人民幣146.8百萬元
增加132.7%至截至二零二六年六月三十日止六個月的約人民幣341.7百萬元。研
發開支大幅增加主要由於本集團對推進其全面代謝性疾病管線(包括小分子及多
肽)的戰略承諾。本集團的期內虧損由截至二零二五年六月三十日止六個月的約
人民幣88.0百萬元增加263.5%至截至二零二六年六月三十日止六個月的約人民幣
319.7百萬元,主要由於上述研發成本增加。
於報告期內及直至本公告日期,本集團的管線及其進展概述如下:
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代謝性疾病管線 - 小分子
產品
(產品類型)
靶點
適應症
權益區域
ASC30
(每日一次口服
小分子激動劑)
GLP-1R
肥胖症
全球
ASC30
(每日一次口服
小分子激動劑)
GLP-1R
糖尿病
全球
ASC39
(每日一次口服
小分子激動劑)
胰淀素受體SARA
肥胖症
全球
ASC30_39FDC
(每日一次口服
小分子雙靶點激動劑)
GLP-1R/
胰淀素受體SARA
肥胖症
全球
ASC30_48FDC
(每日一次口服
小分子雙靶點激動劑)
GLP-1R/GIPR
肥胖症
全球
ASC30_48_39FDC
(每日一次口服
小分子三靶點激動劑)
GLP-1R/GIPR/
胰淀素受體SARA
肥胖症
全球
Discovery
IND Enabling
I期
II期
Ⅲ期
Discovery
IND Enabling
I期
II期
III期
Discovery
IND Enabling
I期
II期
III期
III期
NDA
代謝性疾病管線 - 多肽
產品
(產品類型)
靶點
適應症
權益區域
ASC36i
(每月一次至每季度一次
皮下注射激動劑多肽)
胰淀素受體
肥胖症
全球
ASC36o
(口服激動劑多肽)
胰淀素受體
肥胖症
全球
ASC35
(每月一次皮下
注射激動劑多肽)
GLP-1R/GIPR
肥胖症
全球
ASC36_35FDC
(每月一次皮下注射
三靶點激動劑多肽)
胰淀素受體+
GLP-1R/GIPR
肥胖症
全球
ASC37i
(每月一次皮下注射
三靶點激動劑多肽)
GLP-1R/GIPR/GCGR
肥胖症
全球
ASC37o
(口服激動劑多肽)
GLP-1R/GIPR/GCGR
肥胖症
全球
ASC36_37FDC
(每月一次皮下注射
四靶點激動劑多肽)
胰淀素受體+
GLP-1R/GIPR/GCGR
肥胖症
全球
免疫性疾病管線
產品
(產品類型)
靶點
適應症
權益區域
ASC50
(每日一次口服
小分子抑制劑)
IL-17A
銀屑病及
其他免疫性疾病
全球
ASC51
(每日一次口服
小分子降解劑)
STAT6
免疫性疾病
全球
ASC52
(每日一次口服環肽抑制劑)
IL-17A和F
免疫性疾病
全球
拓展性適應症管線
產品
(產品類型)
靶點
適應症
權益區域
ASC40
(口服小分子)
脂肪酸合成酶
(FASN)
痤瘡
大中華區1
Discovery
IND Enabling
I期
II期
附註: 1.本集團已從Sagimet獲得地尼法司他(ASC40)的大中華區獨家授權。
縮寫: GLP-1R:胰高血糖素樣肽-1受體;SARA:選擇性胰淀素受體激動劑;FDC:固定劑量複方製劑;GIPR:
葡萄糖依賴性促胰島素多肽受體;GCGR:胰高血糖素受體;STAT6:信號轉導和轉錄激活因子6;IL-17A
和F:白細胞介素-17A和F;FASN:脂肪酸合成酶。
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管理層討論與分析
業務回顧
於報告期內及直至本公告日期,本集團已就其業務取得以下進展。
代謝性疾病
小分子
治療肥胖症的ASC30每日一次口服片
於報告期內及直至本公告日期,本集團已獲得FDA的III期臨床研究批准,並已針
對ASC30長期體重管理適應症啟動了一項全球III期臨床項目,該項目由兩項關鍵
的多中心、隨機、雙盲、安慰劑對照的全球III期試驗(AURORA-1, NCT07743463
和AURORA-2, NCT07743450)組成,將在美國、歐洲和加拿大共入組約4,600名
肥胖或超重受試者。近期,ASC30用於長期體重管理的全球III期臨床項目已完成
首例受試者給藥。
這兩項關鍵研究將評估每日一次口服三種維持劑量(20毫克、40毫克和60毫克)的
ASC30對比安慰劑,在不伴有2型糖尿病的肥胖或超重受試者(AURORA-1)以及伴
有2型糖尿病的肥胖或超重受試者(AURORA-2)中的長期療效、安全性和耐受性。
AURORA-1和AURORA-2的治療週期均為72週。
本公司預計將於二零二八年第三季度公佈ASC30 III期臨床項目的頂線數據,並計
劃於二零二八年底向FDA提交NDA以及於二零二九年初向EMA遞交MAA。如獲
得美國和歐洲相關監管機構的批准,ASC30將有望成為繼orforglipron後,在美國
和歐洲獲批的第二款口服小分子GLP-1。
預計二零二六年里程碑: 由於ASC30用於長期體重管理的全球III期臨床項目已完
成首例受試者給藥,本集團已完成二零二六年里程碑。
治療糖尿病的ASC30每日一次口服片
於報告期內及直至本公告日期,本集團已完成其評估口服小分子GLP-1R激動劑
ASC30治療2型糖尿病的為期13週的美國II期研究(NCT07321678)入組。2型糖尿
病是ASC30繼肥胖症(其首個適應症)之後的第二個適應症。
預計二零二六年里程碑: 預計將於二零二六年第三季度公佈ASC30每日一次口服
片治療糖尿病的為期13週的美國II期研究的頂線數據。
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治療肥胖症的ASC39每日一次口服片
於報告期內及直至本公告日期,本集團已選定 ASC39(一款潛在同類首創、與
eloralintide類似的每日一次口服小分子胰淀素選擇性受體激動劑(SARA))作為臨
床開發候選藥物。
在與eloralintide的頭對頭cAMP激活實驗中,口服小分子胰淀素受體激動劑ASC39
顯示出與eloralintide相似的選擇性與活性。ASC39 與eloralintide對hAMY1R的
EC50 分別為21.4 pM和21.2 pM。ASC39與eloralintide對hCTR的EC50 分別為846.1
pM 和 1,350.8 pM。這些數據表明,相較於 hCTR,ASC39 與 eloralintide 都對
hAMY1R更具有選擇性,且選擇性相當。
在與eloralintide的頭對頭DIO大鼠研究中,ASC39的口服給藥療效與eloralintide的
相當,顯示出顯著的、經安慰劑校正後的體重下降,ASC39為6.6%,eloralintide
為5.6%。
預計二零二六年里程碑: 預計將於二零二六年第三季度向FDA遞交ASC39口服片
治療肥胖症的IND申請。
治療肥胖症的ASC30_39FDC每日一次口服片
於報告期內及直至本公告日期,本集團已選定 ASC30_39FDC 進行臨床開發,
ASC30_39FDC為ASC30(一款每日一次口服小分子GLP-1R激動劑)與ASC39(一
款潛在同類首創、與eloralintide類似的每日一次口服小分子SARA)的固定劑量複
方製劑。
在一項頭對頭研究中,ASC30_39FDC片在犬中口服給藥後,其藥代動力學表現與
在各自單藥療法中觀察到的表現相當。該固定劑量複方製劑表現出良好的口服生
物利用度、藥物暴露量以及長達12小時的半衰期。這些數據支持ASC30_39FDC
片有望成為每日一片的新型肥胖症療法。
ASC30_39FDC顯示出ASC30與ASC39聯合製備時具有良好的兼容性,以及室溫
穩定性和小片劑規格的特點。
預計二零二六年里程碑: 預計將於二零二六年第三季度向FDA遞交ASC30_39FDC
口服片治療肥胖症的IND申請。
治療肥胖症的ASC30_48FDC每日一次口服片
於報告期內及直至本公告日期,本集團已選定ASC48(一款潛在同類首創口服小
分子GIPR激動劑)與ASC30(一款口服小分子GLP-1R激動劑)的固定劑量複方製
劑進行臨床開發。ASC30_48FDC同時靶向GLP-1R及GIPR,有望成為同類首創、
每日一次、每次一片的口服肥胖症療法。
在hGIPR cAMP激活實驗中,ASC48的EC50 為1 pM,展現出比替爾泊肽(EC50 = 3
pM)更強的激動活性,且為GIPR的選擇性激動劑,對GLP-1R和GCGR無激動活
性。
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在嚙齒類動物和非人靈長類動物中,ASC48展現出了極佳的口服生物利用度、藥
物暴露量和較長的半衰期,支持在人體中每日一次口服給藥。
在頭對頭非人靈長類動物研究中,ASC30_48FDC的減重效果較ASC30單藥相對
提升約52%。
預計二零二六年里程碑: 預計將於二零二六年第四季度向FDA遞交ASC30_48FDC
口服片治療肥胖症的IND申請。
治療肥胖症的ASC30_48_39FDC每日一次口服片
於報告期內及直至本公告日期,本集團已公佈其潛在同類首創、每日一次口服小
分子GLP-1/GIP╱ 胰淀素三靶點激動劑固定劑量複方製劑的積極數據。其顯示出
對GIPR激動劑(ASC48)的劑量依賴性,經七日治療後,在非人靈長類動物中,據
統計,顯著減重高達15.2%。這表明相較於靶向GLP-1R及胰淀素受體(SARA)的
口服雙靶點激動劑固定劑量複方製劑(ASC30_39FDC),減重效果相對提升高達
120%。該項數據表明GIP成分(ASC48)對ASC30_48_39FDC三靶點激動劑至關重
要。
預計二零二六年里程碑: 預計將於二零二六年第四季度向FDA遞交ASC30_48_39FDC
口服片治療肥胖症的IND申請。
多肽
治療肥胖症的ASC36每月一次至每季度一次皮下注射多肽
於報告期內及直至本公告日期,本集團已獲得FDA對ASC36(一款每月一次至每
季度一次的新一代胰淀素受體激動劑多肽)的IND批准,並已啟動其I期研究。
ASC36每月一次至每季度一次製劑為SALD製劑,由歌禮利用其超長效藥物開發
平台(ULAP)技術自主開發。
在頭對頭非人靈長類動物研究中,ASC36 SALD製劑的表觀半衰期約為eloralintide
的6倍,支持在人體中每月一次至每季度一次皮下給藥。
在頭對頭DIO大鼠研究中,ASC36單藥較petrelintide單藥和eloralintide單藥的減重
效果分別相對提升約91%和32%。
預計二零二六年里程碑: 預計將於二零二六年末前公佈ASC36每月一次至每季度
一次皮下注射多肽的頂線藥代動力學數據。
治療肥胖症的ASC36口服多肽
於報告期內及直至本公告日期,本集團已向FDA遞交ASC36口服片的IND申請。
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在非人靈長類動物研究中,通過利用歌禮口服多肽遞送增強技術(POTENT),ASC36
口服片在穩定狀態下的絕對口服生物利用度達6%至8%。
在非人靈長類動物中,ASC36 口服片每日一次給藥7 天後,使相對基線的平均體
重下降高達13.2%。ASC36片亦顯著減少了食物攝入。
憑藉潛在更優的口服生物利用度和療效,預計ASC36口服片的給藥劑量更低。每
毫克ASC36多肽更優越的減重效果,也可能使其在規模化生產中成本更低。
預計二零二六年里程碑: 預計將於二零二六年第三季度啟動ASC36口服多肽治療
肥胖症的I期試驗。
治療肥胖症的ASC35每月一次皮下注射多肽
於報告期內及直至本公告日期,本集團已獲得 FDA 對治療肥胖症的 ASC35(一
款潛在同類最佳、每月一次皮下注射GLP-1R/GIPR雙靶點激動劑多肽)的IND批
准,並已啟動其I期研究。
ASC35每月一次製劑為SALD製劑,由歌禮利用其超長效藥物開發平台(ULAP)技
術自主開發。在頭對頭非人靈長類動物研究中,ASC35的平均表觀半衰期約比替
爾泊肽長6倍,支持在人體中每月一次皮下給藥。
在頭對頭DIO小鼠研究中,ASC35的減重效果較替爾泊肽相對提升約71%。
預計二零二六年里程碑: 預計將於二零二六年末前公佈ASC35每月一次皮下注射
多肽的頂線藥代動力學數據。
治療肥胖症的ASC36_35FDC每月一次皮下注射多肽
於報告期內及直至本公告日期,本集團已獲得FDA對ASC36_35FDC(一款ASC36
與ASC35的皮下固定劑量複方月注射劑)IND批准,並已啟動其I期研究。
ASC36_35FDC每月一次製劑為SALD製劑,由歌禮利用其超長效藥物開發平台
(ULAP)技術自主開發。
在非人靈長類動物研究中,ASC36和ASC35兩者在ASC36_35FDC SALD複方製
劑中均具有較長的表觀半衰期,支持在人體中每月一次皮下給藥。
在頭對頭DIO大鼠研究中,ASC36_35FDC靶向胰淀素受體、GLP-1R及GIPR三個
靶點,減重效果較eloralintide聯合替爾泊肽相對提升約51%。
預計二零二七年里程碑: 預計將於二零二七年第一季度初公佈ASC36_35FDC每月
一次皮下注射多肽的頂線藥代動力學數據。
9
治療肥胖症的ASC37每月一次皮下注射多肽
於報告期內及直至本公告日期,本集團已選定新一代每月一次皮下給藥的GLP1R/GIPR/GCGR三靶點激動劑多肽ASC37注射劑作為臨床開發候選藥物。
經精準定向設計,ASC37包含41個α-氨基酸,符合生物製品資格。ASC37每月一
次皮下製劑的生物製品許可申請(BLA)將在III期研究完成後向FDA遞交。
ASC37皮下SALD製劑的平均表觀半衰期約為17天,而retatrutide為2.5天。ASC37
這一約7倍長於retatrutide的半衰期,支持每月一次或更低的給藥頻率。
在DIO小鼠模型中,ASC37的減重效果較替爾泊肽相對提升88%,且差異具有統
計學顯著性。
預計二零二六年里程碑: 預計將於二零二六年第三季度向FDA遞交ASC37注射劑
治療肥胖症的IND申請。
治療肥胖症的ASC37口服多肽
於報告期內及直至本公告日期,本集團持續開發ASC37口服片。
預計二零二六年里程碑: 預計將於二零二六年第三季度向FDA遞交ASC37口服片
治療肥胖症的IND申請。
治療肥胖症的ASC36_37FDC每月一次皮下注射多肽
於報告期內及直至本公告日期,本集團已選定GLP-1/GIP/GCG╱ 胰淀素四靶點激
動劑、ASC36與ASC37的皮下固定劑量複方月注射劑ASC36_37FDC。
預計二零二六年里程碑: 預計將於二零二六年第三季度向FDA遞交ASC36_37FDC
注射劑治療肥胖症的IND申請。
儘管於報告期內及直至本公告日期本集團在免疫性疾病管線方面取得重大進展,
但其已作出戰略決策,重點關注其代謝性疾病管線,並尋求ASC50、ASC51 及
ASC52對外授權的機會。該策略將令本集團將其全部資源集中於其代謝性疾病管
線,並擁有充足的在手現金支持其運營至二零二九年。
於報告期內及直至本公告日期,本集團在地尼法司他(ASC40)治療中重度痤瘡適
應症的NDA方面與國家藥監局展開積極溝通。本集團持續與國家藥監局對接,以
期令地尼法司他(ASC40)惠及患者。本集團已從Sagimet獲得地尼法司他(ASC40)
的大中華區獨家授權。
10
臨床前發現
基於其三個核心探索引擎:(i)基於結構的AI輔助藥物發現(AISBDD)平台;(ii)超
長效藥物開發平台(ULAP);及(iii)口服多肽遞送增強技術(POTENT),本集團繼
續加強探索,以開發更多具有全球同類最佳和同類首創競爭力的小分子及多肽管
線產品。
上市規則第18A.05及18A.08(3)條規定的警示聲明:我們無法保證我們將能夠最終
令管線中的候選藥物成功開發、銷售及 ╱ 或商業化。
本集團的設施
本集團在浙江省紹興市有總建築面積約為17,000平方米的製造廠。該廠配備先進
的生產設備,具有尖端技術能力,例如熱熔擠出機及高速壓片機,以確保我們產
品的高質量。
於二零二六年六月三十日,本集團擁有10家全資附屬公司。本集團大部分業務通
過在香港的歌禮製藥(中國)開展,而本集團小部分業務通過在中國內地的歌禮生
物科技及歌禮藥業開展。
未來及前景
本集團已建立擁有關鍵臨床階段資產的全面代謝性疾病管線。以下為二零二六年
下半年的策略及展望:
1.
預計將於二零二六年第三季度公佈每日一次ASC30片治療糖尿病的為期13週
的美國II期研究的頂線數據;
2.
預計將於二零二六年第三季度向FDA遞交ASC39口服片治療肥胖症的IND申
請;
3.
預計將於二零二六年第三季度向FDA遞交ASC30_39FDC口服片治療肥胖症
的IND申請;
4.
預計將於二零二六年第四季度向FDA遞交ASC30_48FDC口服片治療肥胖症
的IND申請;
5.
預計將於二零二六年第四季度向FDA遞交ASC30_48_39FDC口服片治療肥胖
症的IND申請;
6.
預計將於二零二六年末前公佈ASC36每月一次至每季度一次皮下注射多肽的
頂線藥代動力學數據;
11
7.
預計將於二零二六年第三季度啟動ASC36口服多肽治療肥胖症的I期試驗;
8.
預計將於二零二六年末前公佈ASC35每月一次皮下注射多肽的頂線藥代動力
學數據;
9.
預計將於二零二六年第三季度向FDA遞交ASC37注射劑治療肥胖症的IND申
請;
10. 預計將於二零二六年第三季度向FDA遞交ASC37口服片治療肥胖症的IND申
請;
11. 預計將於二零二六年第三季度向FDA遞交ASC36_37FDC注射劑治療肥胖症
的IND申請;
12. 持續加強早期研發工作,開發更多具全球同類最佳及同類首創競爭力的管線
資產;
13. 與全球大型製藥企業尋求對外授權合作機會,以實現本集團價值最大化;及
14. 本集團擁有充足的在手現金,除覆蓋預計向FDA提交的NDA及向EMA提交
的MAA外,可支持其運營至二零二九年。
財務回顧
收入總額
本集團收入總額為收入、其他收入及收益,由截至二零二五年六月三十日止六個
月的約人民幣103.6百萬元減少至截至二零二六年六月三十日止六個月的約人民幣
53.0百萬元,主要由於一次性非經常性收入(主要來自中國內地實體的政府補助)
減少。
其他收入及收益
本集團其他收入及收益由截至二零二五年六月三十日止六個月的約人民幣102.5百
萬元減少48.3%至截至二零二六年六月三十日止六個月的約人民幣53.0 百萬元,
主要由於(i)中國內地實體的政府補助由截至二零二五年六月三十日止六個月的約
人民幣34.2百萬元減少至截至二零二六年六月三十日止六個月的約人民幣1.2百萬
元;(ii)權益投資的已變現及未變現收益淨額由截至二零二五年六月三十日止六
個月的約人民幣37.7百萬元減至截至二零二六年六月三十日止六個月的約人民幣
17.3百萬元。該減少主要歸因於按公平值計入損益計量的本集團於Sagimet的投資
的公平值收益減少,原因為Sagimet股價於報告期內的升值幅度低於二零二五年同
期;及(iii)匯兌虧損由截至二零二五年六月三十日止六個月的約人民幣1.3百萬元
大幅增加至截至二零二六年六月三十日止六個月的約人民幣10.1百萬元,被銀行
利息收入由截至二零二五年六月三十日止六個月的約人民幣30.0百萬元大幅增至
截至二零二六年六月三十日止六個月的人民幣39.5百萬元所抵銷。
12
下表載列於所示期間其他收入及收益的組成部分:
未經審核
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
銀行利息收入
權益投資產生已變現及未變現收益淨額
理財產品及結構性存款產生已變現及未變現
收益淨額
按公平值計入其他全面收入的金融資產的已變
現及未變現收益淨額
政府補助
匯兌虧損淨額
其他
總計
39,466
17,336
30,037
37,679
3,643
1,472
709
1,188
(10,110)
747
431
34,175
(1,308)
10
52,979
102,496
行政開支
本集團的行政開支由截至二零二五年六月三十日止六個月的約人民幣43.3百萬元
減少28.9%至截至二零二六年六月三十日止六個月的約人民幣30.8百萬元,主要是
由於員工相關成本減少。
我們的行政開支主要包括(i)非研發人員的員工薪金及福利成本;(ii)代理及諮詢
費;及(iii)公用能耗、租金及一般辦公室開支。
下表載列於所示期間我們行政開支的組成部分:
未經審核
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
%
員工薪金及福利
代理及諮詢費
公用能耗、租金及
一般辦公室開支
其他
12,612
13,959
40.9
45.3
20,517
17,548
47.4
40.5
4,092
140
13.3
0.5
4,897
340
11.3
0.8
總計
30,803
100.0
43,302
100.0
13
研發開支
本集團的研發開支主要包括臨床前及臨床試驗開支、員工成本以及折舊及攤銷成
本。
本集團的研發開支由截至二零二五年六月三十日止六個月的約人民幣146.8百萬元
增加132.7%至截至二零二六年六月三十日止六個月的約人民幣341.7百萬元,主
要由於本集團已增加對代謝性疾病產品管線的投資。
本集團增加對代謝性疾病產品管線的投資,乃配合該領域所取得的重大進展。
儘管研發開支大幅增加,惟於二零二六年六月三十日,本集團擁有現金及現金等
價物、定期存款、可轉讓存單、結構性存款及理財產品約人民幣2,305.4 百萬元
(二零二五年六月三十日:約人民幣1,827.9 百萬元),可支持其運營至二零二九
年。
下表載列於所示期間研發成本的組成部分:
未經審核
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
臨床前及臨床試驗開支
員工成本
折舊及攤銷成本
其他
268,394
55,812
7,657
9,800
75,897
60,796
5,553
4,566
總計
341,663
146,812
下表載列於所示期間按產品管線劃分的研發成本組成部分:
未經審核
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
代謝性疾病
拓展性適應症
臨床前
145,777
14,506
181,380
42,640
66,149
38,023
總計
341,663
146,812
14
融資成本
由於租賃負債的利息的影響,本集團於截至二零二六年六月三十日止六個月錄得
融資成本約人民幣0.1百萬元(二零二五年六月三十日:約人民幣0.1百萬元)。
所得稅
本集團須按實體基準就產生自或源自本集團成員公司註冊及營運所在司法權區的
溢利繳納所得稅。
本集團使用適用於預期年度盈利總額之稅率計算所得稅開支。
本集團於截至二零二六年六月三十日止六個月錄得所得稅約人民幣0.1百萬元(二
零二五年六月三十日:無)。
存貨
本集團的存貨包括研發所用的原材料。我們的存貨由二零二五年十二月三十一日
的約人民幣1.9百萬元減少37.6%至二零二六年六月三十日的約人民幣1.2百萬元,
主要是由於加強存貨管理。
下表載列截至所示日期的存貨結餘:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
原材料
1,169
1,874
總計
1,169
1,874
貿易應收款項
本集團的貿易應收款項由二零二五年十二月三十一日的約人民幣0.2百萬元減少至
二零二六年六月三十日的零。
下表載列截至所示日期的貿易應收款項結餘:
15
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
貿易應收款項
–
223
總計
–
223
本集團與客戶之交易條款主要為授出信貸期。信貸期通常為30日至90日。本集團
力求就其尚未收取應收款項維繫嚴格的控制及逾期結餘由高級管理層定期審閱。
貿易應收款項為不計息。
於所示日期之貿易應收款項基於發票日期並扣除虧損撥備之賬齡分析如下:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
三個月內
–
223
–
223
預付款項、其他應收款項及其他資產
下表載列於所示日期的預付款項、其他應收款項及其他資產的組成部分:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
可抵扣增值稅
按金及其他應收款項
預付款項
預付開支
17,362
4,122
3,478
1,250
9,940
3,056
3,544
1,207
總計
26,212
17,747
16
我們的可抵扣增值稅指可結轉用以抵銷未來銷項增值稅(「增值稅」),或由相關稅
務機關退還的增值稅。我們的可抵扣增值稅由二零二五年十二月三十一日的約人
民幣9.9百萬元增加74.7%至二零二六年六月三十日的約人民幣17.4百萬元,主要
由於報告期內研發開支增加引致的增值稅進項稅額增加。
按金及其他應收款項為雜項開支,包括租金及其他按金。
我們的預付款項主要與購買臨床試驗服務有關,截至二零二六年六月三十日止六
個月約為人民幣3.5百萬元(二零二五年六月三十日:約人民幣3.5百萬元)。
於二零二六年六月三十日,向供應商作出之預付款項於一年內到期。
於二零二六年六月三十日,本集團並無就預付款項、其他應收款項及其他資產計
提減值虧損。
按公平值計入損益的金融資產 - 非流動
本集團按公平值計入損益的金融資產非流動部分(主要由本集團於Sagimet納斯達
克上市股票的投資組成)由二零二五年十二月三十一日的人民幣56.4百萬元增加至
二零二六年六月三十日的約人民幣68.7百萬元,主要是由於期內Sagimet的股份報
價有所提升。
按公平值計入損益的金融資產 - 流動
本集團按公平值計入損益的金融資產流動部分由二零二五年十二月三十一日的約
人民幣26.1百萬元減少至二零二六年六月三十日的約人民幣24.9百萬元,主要是
由於減少對理財產品的投資。
現金及銀行結餘
下表載列於所示日期本集團的定期存款以及現金及現金等價物的組成部分:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
定期存款
現金及現金等價物
1,616,939
593,371
431,259
1,443,513
總計
2,210,310
1,874,772
17
原到期日超過三個月的定期存款乃根據我們的即時現金需求按不同期限作出,並
按各項定期存款的利率賺取利息。現金及現金等價物以及定期存款根據每日銀行
存款利率及相關定期存款利率按浮動利率計息。現金及現金等價物及定期存款存
放於信譽度高且無近期違約歷史的銀行。
貿易應付款項
本集團的貿易應付款項主要包括支付予原材料供應商的款項。下表載列我們於所
示日期的貿易應付款項的組成部分:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
貿易應付款項
14,623
1,344
總計
14,623
1,344
下表載列於所示日期的貿易應付款項基於發票日期之賬齡分析:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
少於三個月
14,623
1,344
其他應付款項及應計費用
下表載列於所示日期的其他應付款項及尚未支付的應計費用之組成部分:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
應計開支
其他應付款項
應付工資
撥備
除所得稅外之稅項
101,785
36,569
16,577
4,038
217
69,375
30,630
17,217
4,038
529
總計
159,186
121,789
18
於二零二六年六月三十日的應計開支主要為實際已產生但尚未開具發票的應計研
發開支。應計開支由二零二五年十二月三十一日的約人民幣69.4百萬元增加至二
零二六年六月三十日的約人民幣101.8百萬元。應計開支不計息且於一年內到期。
我們的其他應付款項保持相對穩定,由二零二五年十二月三十一日的約人民幣
30.6百萬元增加至二零二六年六月三十日的約人民幣36.6百萬元。
應付工資為二零二六年上半年的應計工資及獎金,且於一年內到期。應付工資由
二零二五年十二月三十一日的約人民幣17.2百萬元減少至二零二六年六月三十日
的約人民幣16.6百萬元,主要由於應計工資及獎金減少。
於二零二五年十二月三十一日及二零二六年六月三十日,撥備均保持不變,為約
人民幣4.0百萬元。
遞延收入
本集團的遞延收入指本集團的中國內地附屬公司已收取以補償相關實體資產成本
的政府補助的未攤銷部分,該款項其後於相關資產的可使用年期內在損益確認為
收入。下表載列截至所示日期的遞延收入:
於二零二六年
六月三十日
於二零二五年
十二月三十一日
(未經審核)
人民幣千元
(經審核)
人民幣千元
政府補助
- 即期
- 非即期
1,588
1,588
1,588
2,382
總計
3,176
3,970
流動資金及資本資源
本集團現金的主要用途是為研發活動、購買設備及原材料以及其他經常性支出提
供資金。於報告期內,本集團以全球發售、補足配售及根據一般授權進行的配售
的所得款項為營運資金及其他資本開支需求提供資金。
19
下表載列本集團於所示期間的簡明綜合現金流量表概要及於所示期間的現金及現
金等價物結餘分析:
經營活動所用現金淨額
投資活動(所用)╱ 所得現金淨額
融資活動所得 ╱(所用)現金淨額
現金及現金等價物(減少)╱ 增加淨額
期初現金及現金等價物
外匯匯率變動的影響淨額
期末現金及現金等價物
截至
二零二六年
六月三十日
止六個月
(未經審核)
人民幣千元
截至
二零二五年
六月三十日
止六個月
(未經審核)
人民幣千元
(327,349)
(1,192,401)
708,762
(810,988)
1,443,513
(39,154)
(172,990)
904,605
(14,485)
717,130
864,326
(1,116)
593,371
1,580,340
於二零二六年六月三十日,現金及現金等價物主要以人民幣及美元計值。
經營活動
我們經營活動的現金流入主要包括已收客戶的貿易應收款項及政府補助,截至目
前,本集團收到的政府補助全部來自中國內地實體及澳洲實體,並未從香港實體
收到過該等補助。我們經營活動的現金流出主要包括研發成本及行政開支付款。
截至二零二六年六月三十日止六個月,我們的經營活動所用現金淨額約為人民幣
327.3百萬元,乃主要由於營運資金變動前的經營虧損約為人民幣358.3百萬元。
營運資金的變動乃主要由於支付研發成本。
投資活動
我們的投資活動所用現金主要包括購買原到期日為三個月以上的定期存款、購買
物業、廠房及設備、購買無形資產及購買按公平值計入損益的金融資產。
20
截至二零二六年六月三十日止六個月,我們的投資活動所用現金淨額約為人民
幣1,192.4 百萬元,乃主要由於原到期日為三個月以上的定期存款增加約人民幣
1,194.1百萬元。
融資活動
我們的融資活動所得現金主要與根據一般授權配售新股的所得款項有關。
截至二零二六年六月三十日止六個月,我們的融資活動所得現金淨額約為人民幣
708.8百萬元,主要由於根據一般授權配售新股的所得款項約人民幣742.3百萬元。
資本開支
本集團的主要資本開支主要包括購買辦公設備以及廠房及機器。下表載列我們於
所示日期的資本開支淨額:
二零二六年
二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
人民幣千元
人民幣千元
辦公設備
廠房及機器
9
1,224
872
468
總計
1,233
1,340
我們的資本開支由二零二五年十二月三十一日的約人民幣1.3百萬元減少8.0%至二
零二六年六月三十日的約人民幣1.2百萬元,乃主要由於我們減少購買實驗室裝修
所需的辦公設備。
所持重大投資、重大收購及出售
除本公告披露者外,截至二零二六年六月三十日止六個月,本集團並無任何根據
上市規則附錄D2第32(4A)段須予披露的重大投資,亦無對附屬公司及聯營公司進
行任何重大收購或出售。
債項
借款、資產抵押及擔保
於二零二六年六月三十日,本集團並無任何未清償的按揭、押記、債券、其他已
發行債務資本、銀行透支、借款、承兌負債或其他類似債務、任何擔保或其他重
大或然負債。
21
或然負債
(a) Viking案
於二零二二年十二月二十九日,Viking Therapeutics, Inc.(「Viking」,一家位
於美國的製藥公司)就本集團的候選藥物ASC41及ASC43F向本公司、其創始
人吳勁梓及本公司若干附屬公司作出若干控告。一項控告向位於華盛頓特區
的美國國際貿易委員會(「ITC」)提出,另一項控告則向美國加利福尼亞州南
區地方法院(「USDC」)聖迭戈分院提出,各項控告所列指控相似。
於二零二四年十月四日及二零二五年五月二十九日,本公司收到ITC對該控
告的初步裁定及最終判決(統稱「判決」)。ITC行政法官作出的判決認定本公
司候選藥物ASC41 和ASC43F進口至美國違反《1930 年關稅法案》
(修訂版)
第337條。此外,由於調查階段的若干程序問題,判決提出處以567,000美元
(相當於約人民幣4,038,000元)的罰款。本公司已在財務報表中為該項罰款計
提撥備。
就向USDC提出的控告而言,自二零二六年一月一日以來未有重大進展,相
關調查和訴訟程序正在進行中。本公司將就控告積極進行抗辯。因此,於二
零二六年六月三十日,本集團尚未對Viking向USDC提交的控告所引起的指
控作出任何撥備。
(b) 仲裁案
於二零二五年九月,歌禮藥業捲入一宗由先前客戶發起的仲裁程序,該程序
主要源於有關若干產品銷售的商業合約糾紛。
申訴人要求賠償總額約人民幣25百萬元,其中包括(i)合約付款,(ii)涉嫌佔用
資金的利息,及(iii)仲裁和法律費用。
於本公告日期,仲裁仍在進行中,尚未作出裁決。根據目前可獲得的信息,
無法可靠地估計仲裁結果及其對本集團的潛在財務影響。於二零二六年六月
三十日,本集團概無就該仲裁作出任何撥備。
資產抵押
於二零二六年六月三十日,本集團並無資產抵押。
22
合約承擔
我們根據經營租賃安排租賃部分物業及倉庫。磋商的物業及倉庫租期主要介於一
至三年。
於二零二六年六月三十日,本集團的資本承擔約為人民幣3.2百萬元,而於二零二
五年十二月三十一日,資本承擔約為人民幣0.6百萬元。
主要財務比率
下表載列截至所示日期的主要財務比率:
於二零二六年
於二零二五年
六月三十日 十二月三十一日
(未經審核)
(經審核)
流動比率 (1)
速動比率 (2)
資產負債比率 (3)
12.9
12.9
7.4%
15.1
15.0
6.4%
附註:
(1)
流動比率指流動資產除以截至同日的流動負債。
(2)
速動比率指流動資產減存貨後除以截至同日的流動負債。
(3)
資產負債比率指負債總額除以截至同日的資產總值再乘以100%。
我們的流動比率由二零二五年十二月三十一日的15.1減少至二零二六年六月三十
日的12.9,而我們的速動比率由二零二五年十二月三十一日的15.0減少至二零二
六年六月三十日的12.9,主要是由於流動負債增加所致。
我們的資產負債比率由二零二五年十二月三十一日的6.4%增加至二零二六年六月
三十日的7.4%,主要由於流動負債增加。
外匯風險
外匯風險指外匯匯率變動造成損失的風險。人民幣與本集團開展業務所涉及的其
他貨幣之間的匯率波動或會影響我們的財務狀況及經營業績。
本集團主要於中國經營業務,並面臨來自多種貨幣風險的外匯風險(主要為美
元)。外匯風險來自海外業務的已確認資產及負債。將外幣(包括美元)兌換為人
民幣以中國人民銀行設定的匯率換算。本集團尋求透過密切監控及最小化外匯淨
頭寸來限制其面臨的外匯風險。於報告期內,本集團並無訂立任何貨幣對沖交易。
23
僱員及薪酬政策
本集團董事及高級管理層的薪酬乃由董事會參考薪酬委員會的建議,並考慮本集
團的經營業績、同類公司支付的薪酬、董事及高級管理層須付出的時間及其職責
以及聘任條件後釐定。
於二零二六年六月三十日,本集團共有217 名僱員,其中大多數僱員位於中國。
超過79.7%的僱員持有學士或更高學位。下表載列本集團所披露的按職能劃分的
僱員情況:
於二零二六年六月三十日
員工人數
佔總數%
管理
研發
製造
營運
3
149
32
33
1.4
68.7
14.7
15.2
總計
217
100.0
截至二零二六年六月三十日止六個月,本集團的總員工成本約為人民幣68.4百萬
元,而截至二零二五年六月三十日止六個月約為人民幣82.1百萬元。
本集團透過招聘網站、招聘人員、內部推介和招聘會來招聘員工。本集團為員工
提供新員工培訓以及專業與合規培訓課程。
本集團與員工訂立聘用合約,以涵蓋工資、福利及終止依據等事宜。我們員工的
薪酬待遇包括工資和獎金,一般參考資歷、行業經驗、職位和表現決定。本集團
按照中國法律法規的要求為其員工繳納社會保險和住房公積金。
本集團亦已採納上市規則第十七章所載股份計劃,以獎勵為實現本集團長期發展
而作出持續貢獻的僱員。
24
綜合損益表
截至二零二六年六月三十日止六個月 - 未經審核
二零二六年
人民幣千元
二零二五年
人民幣千元
–
–
1,081
(960)
–
121
52,979
(341,663)
(30,803)
(12)
102,496
(146,812)
(43,302)
(367)
經營虧損
(319,499)
(87,864)
融資成本
(74)
(87)
附註
收益
銷售成本
3
毛利
其他收入及收益
研發成本
行政開支
其他開支
4
除稅前虧損
5
(319,573)
(87,951)
所得稅
6
(98)
–
期內虧損
(319,671)
(87,951)
以下人士應佔:
本公司權益股東
(319,671)
(87,951)
人民幣
(30.74)分
人民幣
(9.14)分
每股虧損
基本及攤薄
7
25
綜合損益及其他全面收入表
截至二零二六年六月三十日止六個月 - 未經審核
二零二六年
人民幣千元
二零二五年
人民幣千元
(319,671)
(87,951)
於往後重新分類或可能重新分類至損益之項目:
換算海外業務產生之匯兌差異
7,850
247
將不會重新分類至損益之項目:
換算為本公司財務報表呈列貨幣之匯兌差異
(65,026)
(5,546)
期內其他全面收入
(57,176)
(5,299)
期內全面虧損總額
(376,847)
(93,250)
以下人士應佔:
本公司權益股東
(376,847)
(93,250)
期內虧損
期內其他全面收入(經扣除稅項)
26
綜合財務狀況表
於二零二六年六月三十日 - 未經審核
附註
非流動資產
物業、廠房及設備
就物業、廠房及設備的預付款項
使用權資產
其他無形資產
按公平值計入其他全面收入(「按公平值
計入其他全面收入」)的金融資產
按公平值計入損益(「按公平值計入
損益」)的金融資產
長期遞延開支
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
35,362
177
4,926
9,383
39,625
259
7,077
10,285
38,007
31,733
68,687
376
56,367
460
156,918
145,806
1,169
–
24,897
26,212
32,164
593,371
1,616,939
1,874
223
26,103
17,747
–
1,443,513
431,259
2,294,752
1,920,719
14,623
159,186
2,240
1,588
1,344
121,789
2,871
1,588
177,637
127,592
流動資產淨值
2,117,115
1,793,127
總資產減流動負債
2,274,033
1,938,933
8
9
流動資產
存貨
貿易應收款項
按公平值計入損益的金融資產
預付款項、其他應收款項及其他資產
按公平值計入其他全面收入的金融資產
現金及現金等價物
原到期日為三個月以上的定期存款
10
流動負債
貿易應付款項
其他應付款項及應計費用
租賃負債
遞延收入
11
27
綜合財務狀況表(續)
於二零二六年六月三十日 - 未經審核
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
非流動負債
租賃負債
遞延收入
1,496
1,588
2,287
2,382
3,084
4,669
資產淨值
2,270,949
1,934,264
資本及儲備
股本
儲備
727
2,270,222
679
1,933,585
本公司權益股東應佔權益總額
2,270,949
1,934,264
權益總額
2,270,949
1,934,264
28
未經審核中期財務報告附註
1.
公司資料
本公司為一家於二零一四年二月二十五日在開曼群島註冊成立的有限公司。本公司的註冊
辦事處位於190 Elgin Avenue, George Town, Grand Cayman KY1-9008, Cayman Islands。
本公司的香港主要營業地點地址為香港灣仔皇后大道東248號大新金融中心40樓。
本公司為一間投資控股公司。本公司的附屬公司主要從事藥品研發。
本公司股份於二零一八年八月一日於香港聯合交易所有限公司(「聯交所」)主板上市。
2.
編製基準及會計政策及披露事項變動
2.1
編製基準
本中期財務報告根據香港聯合交易所有限公司證券上市規則中適用的披露條款編製,包括
遵守香港會計師公會(「香港會計師公會」)發佈的香港會計準則(「香港會計準則」)第34號
中期財務報告 。該報告已獲授權於二零二六年八月三十一日發佈。
中期財務報告按照二零二五年度財務報表中採用的相同會計政策編製,惟預計將於二零二
六年度財務報表中反映的會計政策變動除外。會計政策任何變動的詳情載於附註2.2。
編製符合香港會計準則第34號的中期財務報告時,管理層須作出判斷、估計及假設,而該
等判斷、估計及假設會影響政策應用及以本年至今為基準資產及負債、收入及開支的已呈
報金額。實際結果可能與預估的有所不同。
本中期財務報告包含簡明綜合財務報表及節選附註解釋。附註包括對了解本集團自二零二
五年度財務報表以來的財務狀況及業績變動而言屬重大的事項及交易的解釋。簡明綜合中
期財務報表及隨附附註並不包括按照香港財務報告會計準則編製完整財務報表所需的全部
資料。
中期財務報告未經審核,但已由畢馬威會計師事務所按照香港會計師公會頒佈的香港審閱
委聘準則第2410號實體獨立核數師進行中期財務資料審閱 進行審閱。
2.2
會計政策及披露事項變動
香港會計師公會已頒佈若干香港財務報告會計準則修訂,該等修訂自本會計期間起首次生
效,其中包括:
•
香港財務報告準則第9 號(修訂本),財務工具 及香港財務報告準則第7 號,財務工
具:披露 - 涉及依賴自然能源生產電力的合同
•
香港財務報告準則第9 號(修訂本),財務工具 及香港財務報告準則第7 號,財務工
具:披露 - 財務工具分類及計量之修訂
•
香港財務報告準則之年度改進 - 第11卷
由於本集團並無進行此類交易,故該等修訂對本中期報告並無重大財務影響。
本集團尚未採用於當前會計期間尚未生效的任何新準則或解釋。
29
3.
收入及分部報告
(a)
收入
(i)
收入明細
按產品或服務線劃分的客戶合約收入明細如下:
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
國際財務報告準則第15號範圍內的
客戶合約收入
(b)
隨時間確認:
- 提供研發服務
- 其他
–
–
1,054
27
總計
–
1,081
分部報告
經營分部乃根據本集團最高行政管理層定期審閱分配予分部資源及評估其表現的內
部報告識別。
本集團的最高行政管理層根據內部管理職能作出資源分配決策,並將本集團的業務
表現作為一項綜合業務(而非透過單條業務線或地理區域)進行評估。因此,本集團
僅擁有一個經營分部,且因此並無呈列任何分部資料。
(c)
地區資料
下表載列有關:(i)本集團來自外部客戶的收入;及(ii)本集團的物業、廠房及設備
以及無形資產(「特定非流動資產」)所在地區的資料。客戶所在地區按其經營地點劃
分。特定非流動資產所在地區,如屬物業、廠房及設備,則按資產實際所在地點劃
分,而如屬無形資產,則按所分配的經營地點劃分。
(i)
來自外部客戶的收入
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
(ii)
香港
其他地區
–
–
1,054
27
總計
–
1,081
二零二六年
六月三十日
人民幣千元
二零二五年
十二月三十一日
人民幣千元
中國內地
美國
44,741
4
49,906
4
總計
44,745
49,910
非流動資產
30
4.
其他收入及收益
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
銀行利息收入
權益投資產生已變現及未變現收益淨額
理財產品及結構性存款產生的已變現及
未變現收益淨額
按公平值計入其他全面收入的金融資產的
已變現及未變現收益淨額
政府補助(i)
匯兌虧損淨額
其他
總計
39,466
17,336
30,037
37,679
3,643
1,472
709
1,188
(10,110)
747
431
34,175
(1,308)
10
52,979
102,496
附註:
(i)
5.
政府補助主要指由地方政府為補償研究活動、臨床試驗及日常經營活動產生的開
支、若干項目產生的資本開支及新藥研製獎勵而提供的補助。
除稅前虧損
本集團除稅前虧損乃經扣除 ╱(計入)下列各項得出:
(a)
融資成本
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
租賃負債利息
(b)
74
87
其他項目
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
物業、廠房及設備項目折舊
使用權資產折舊
無形資產攤銷
撇減存貨至可變現淨值
核數師酬金
訴訟開支
以股權結算的股份獎勵及期權開支
6.
5,469
2,151
953
16
551
836
3,274
5,470
2,756
1,214
23
551
1,899
3,836
所得稅
本集團須按實體基準就產生自或源自本集團成員公司註冊及營運所在司法權區的溢利繳納
所得稅。
開曼群島
根據開曼群島現行法律,本公司毋須就收入或資本收益繳納稅項。此外,開曼群島不會對
本公司向其股東派付的股息徵收預扣稅。
31
英屬處女群島
根據英屬處女群島(「英屬處女群島」)現行法律,PowerTree Investment (BVI) Ltd.
(「PowerTree」)毋須就收入或資本收益繳納稅項。此外,英屬處女群島不會對PowerTree
向其股東派付的股息徵收預扣稅。
香港
根據香港現行法例,香港附屬公司須就於香港產生的估計應課稅溢利按16.5%(二零二五
年:16.5%)的稅率繳納利得稅。於報告期內,由於附屬公司並無於香港產生任何應課稅
溢利,故並無作出利得稅撥備。
美國
根據美國現行法律,美國附屬公司須按最高21%(二零二五年:21%)的聯邦企業所得稅稅
率及2.5%(二零二五年:2.5%)的北卡羅來納州稅率繳納稅項。於報告期內,由於該附屬
公司並無於美國產生任何應課稅收入,故並無作出所得稅撥備。
澳洲
根據澳洲現行法律,澳洲附屬公司須按30%(二零二五年:30%)的稅率繳納利得稅。於報
告期內,由於該附屬公司並無於澳洲產生任何應課稅收入,故並無作出所得稅撥備。
中國內地
根據中國企業所得稅法及相關法規(「企業所得稅法」),在中國內地營運的附屬公司須按
25%(二零二五年:25%)的稅率就應課稅收入繳納企業所得稅。
根據企業所得稅法,非居民企業在中國境內未設立機構、場所的,或者雖設立但所得與其
無實際聯繫的,應當就其來源於中國境內的股息等各類被動所得按10%的稅率預扣預繳所
得稅(根據稅收協定予以減免的除外)。
歌禮藥業(浙江)有限公司(「歌禮藥業」)由於被認定為高新技術企業,故報告期內納稅享
有15%的優惠稅率(二零二五年:15%)。
若干中國附屬公司由於被認定為小微企業,故享有5%的優惠中國所得稅稅率。
根據中國國家稅務總局於二零二三年三月頒佈且自二零二三年一月一日起施行的新稅收優
惠政策,符合條件的已產生研發開支可自應課稅收入中加計扣除100%。
7.
每股虧損
每股基本虧損乃根據本公司普通權益股東應佔虧損人民幣319,671,000元(截至二零二五年
六月三十日止六個月:人民幣87,951,000元),及於中期期間發行的1,039,794,415股(截至
二零二五年六月三十日止六個月:962,522,870股)普通股之加權平均數計算。
由於股份獎勵及期權的影響對所示每股基本虧損金額具有反攤薄影響,故並無就有關攤薄
對截至二零二六年及二零二五年六月三十日止期間所示的每股基本虧損金額作出調整。
32
8.
物業、廠房及設備
截至二零二六年六月三十日止六個月期間,本集團以成本人民幣1,233,000元收購資產(截
至二零二五年六月三十日止六個月:人民幣1,072,000元)。
截至二零二六年六月三十日止六個月期間,出售賬面淨值人民幣9,000元的廠房及機器項
目(截至二零二五年六月三十日止六個月:人民幣50,000元),導致出售虧損人民幣9,000
元(截至二零二五年六月三十日止六個月:人民幣50,000元)。
9.
使用權資產
於截至二零二六年六月三十日止六個月,本集團並無簽訂任何新辦公室租賃協議,故期內
並無確認添置使用權資產(截至二零二五年六月三十日止六個月:人民幣2,121,000元)。
10. 貿易應收款項
截至報告期末按發票日期呈列並經扣除虧損撥備的貿易應收款項的賬齡分析如下:
二零二六年
六月三十日
人民幣千元
二零二五年
十二月三十一日
人民幣千元
–
223
二零二六年
六月三十日
人民幣千元
二零二五年
十二月三十一日
人民幣千元
14,623
1,344
少於三個月
11. 貿易應付款項
截至報告期末按發票日期呈列的貿易應付款項的賬齡分析如下:
少於三個月
12. 資本、儲備及股息
(a)
股息
董事會不建議就截至二零二六年六月三十日止六個月派付任何股息(截至二零二五年
六月三十日止六個月:無)。
(b)
股本
(i)
已發行股本
二零二六年
股份數目
人民幣千元
二零二五年
股份數目
人民幣千元
普通股,已發行及已繳足:
於一月一日
註銷股份
發行股份
998,958,530
–
69,496,525
679
–
48
1,012,758,000
(44,896,790)
1,569,285
689
(32)
1
於六月三十日
1,068,455,055
727
969,430,495
658
本公司普通股的面值為每股0.0001美元。
33
(ii)
購回自身股份
於中期期間,本公司於聯交所購回其自身股份如下:
年╱月
二零二六年六月
已購回股份
數目
每股已付
最高價格
港元
每股已付
最低價格
港元
已付價格
總額(包括
交易費用)
千港元
3,745,000
10.77
9.14
37,300
購回股份的已付總額37,300,000港元(相當於人民幣32,438,000元)已悉數支付。
(iii) 註銷已購回股份
截至二零二六年六月三十日止六個月,本公司並無註銷任何已購回股份(截至二零二
五年六月三十日止六個月:44,896,790股股份)。
(iv) 根據購股權計劃已發行股份
截至二零二六年六月三十日止六個月,已行使購股權認購本公司240,525股(截至二
零二五年六月三十日止六個月:1,569,285 股)普通股,代價為人民幣371,000元(截
至二零二五年六月三十日止六個月:人民幣3,849,000元)。少於人民幣1,000元(截至
二零二五年六月三十日止六個月:人民幣1,000元)已計入股本,而人民幣371,000元
(截至二零二五年六月三十日止六個月:人民幣3,848,000元)已計入資本儲備。
(v)
配售新股份
於二零二六年二月十日,本公司成功向不少於六名配售對象配發及發行合共
69,256,000 股新股份(「配售股份」),該等配售對象及其最終實益擁有人均為獨立於
本公司且與本公司、本公司關連人士及本公司或其任何附屬公司之任何董事、監
事、行政總裁或主要股東或其各自聯繫人無關聯之獨立第三方,每股配售股份的配
售價為12.18港元。配售股份約佔經配發及發行配售股份而擴大之已發行股份總數的
6.53%。此次配售的所得款項淨額(扣除佣金及估計開支後)約為835.2百萬港元(相
當於人民幣742.3 百萬元)。更多詳情請參閱本公司日期為二零二六年二月十日之公
告。
(c)
以股權結算以股份為基礎的交易
本公司於二零二五年二月三日採納一項購股權計劃(「二零二五年購股權計劃」)及一
項股份獎勵計劃(「二零二五年股份獎勵計劃」)。該等計劃旨在獎勵董事及僱員為本
集團提供服務,並激勵彼等進一步為本集團作出貢獻。
每份購股權賦予持有人認購一股本公司普通股的權利。該等購股權將於二零二六年
一月十四日至二零二九年一月十四日期間歸屬,並可於二零三五年之前行使。股份
獎勵將於達到特定表現目標後方可歸屬。
截至二零二六年六月三十日止六個月,本公司概無授出任何購股權或股份獎勵(截至
二零二五年六月三十日止六個月:4,820,175份購股權及5,784,210份股份獎勵)。
34
13. 或然負債
(a)
Viking案
於二零二二年十二月二十九日,Viking Therapeutics, Inc.(「Viking」)
(一家位於美
國的製藥公司)就本集團的候選藥物ASC41及ASC43F向本公司、其創始人吳勁梓及
本公司若干附屬公司作出若干控告。一項控告向位於華盛頓特區的美國國際貿易委
員會(「ITC」)提出,另一項控告則向加利福尼亞州南區聖迭戈分部的美國地方法院
(「USDC」)提出,各項控告所列指控相似。
於二零二四年十月四日及二零二五年五月二十九日,本公司收到ITC對該控告的初步
裁定及最終裁定(統稱「裁定」)。ITC行政法官(Administrative Law Judge)作出的裁
定認為,本公司候選藥物ASC41和ASC43F進口至美國違反《1930年關稅法案》
(修訂
版)第337條。此外,由於調查階段的若干程序問題,提出處以567,000美元(相當於
約人民幣4,038,000 元)的經濟制裁。本公司已在財務報表中對該項經濟制裁作出撥
備。
關於向USDC提出的控告,自二零二六年一月一日起並無重大進展,相關調查及訴訟
程序仍在進行中。本公司將就該等控告進行有力抗辯。據此,於二零二六年六月三
十日,本集團並無對因Viking向USDC提出的控告所引起的指控作出任何撥備。
(b)
仲裁案
於二零二五年九月,歌禮藥業捲入了一宗由先前客戶發起的仲裁程序,該程序主要
源於有關若干產品的商業合約糾紛。
申訴人要求賠償總額約人民幣25百萬元,其中包括(i)合約付款,(ii)涉嫌佔用資金的
利息,及(iii)仲裁和法律費用。
於本公告日期,仲裁仍在進行中,尚未作出裁決。根據目前可獲得的信息,無法可
靠地估計仲裁結果及其對本集團的潛在財務影響。於二零二六年六月三十日,本集
團概無就該仲裁作出任何撥備。
35
遵守企業管治守則
本公司致力維持高水平的企業管治,以保障股東權益,提升企業價值,制定其業
務戰略及政策以及提高其透明度及問責性。
本公司已採納上市規則附錄C1所載的企業管治守則的守則條文作為其企業管治的
守則。
董事會認為,本公司於報告期內一直遵守企業管治守則內的所有適用守則條文,
惟偏離企業管治守則第2分部守則條文第C.2.1條,即本公司的董事會主席與行政
總裁的職位並非分開,均由吳博士擔任。本公司是一家擁有專業管理團隊以監管
其附屬公司經營的投資控股公司。董事會認為,董事會主席及行政總裁的職位由
同一人兼任能更有效率地引領及管理本公司,且並不損害董事會的權力及權限與
本公司業務管理的平衡。董事會將不時審閱企業管治架構及慣例,並會在其認為
適當時作出必要安排。
遵守證券交易標準守則
本公司已採納一套其標準不遜於標準守則的書面指引作為其董事進行證券交易的
行為守則。
經向全體董事作出具體查詢後,各位董事均確認彼等於整個報告期間及直至本公
告日期已遵守標準守則及書面指引。於報告期內,本公司並無發現可能掌握本公
司內幕消息的僱員存在不遵守書面指引的情況。
購買、出售或贖回本公司上市證券
本公司不時購回股份,旨在長遠提高股東價值,並為董事會提供更多靈活性以按
現行市價轉售庫存股份,為本公司籌集額外資金,或根據上市規則第十七章的股
份計劃轉讓庫存股份或用作股份授出,或將其用於上市規則、章程細則及開曼群
島適用法例准許的其他用途。於報告期內,本公司於聯交所購回合共3,745,000股
股份,總代價為37,227,010港元,主要用於提高股份價值,從而惠及全體股東。
於報告期內及直至本公告日期,本公司以總代價55,954,050港元,於聯交所購回
本公司合共5,745,000 股股份。於本公告日期,為註銷而購回的9,386,000 股普通
股及1,300,000股庫存股份已經註銷,及於本公告日期,已發行股份總數已相應減
少。
於報告期及直至本公告日期購回的股份詳情如下:
36
成交月份
二零二六年六月
二零二六年七月
總計
已購回股份數目
及購回方式
3,745,000股股份
於聯交所購回
2,000,000股股份
於聯交所購回
每股價格
已付
已付
每股
每股
最高價 最低價
(港元) (港元)
已付總代價
(港元)
10.77
9.14
37,227,010.00
11.67
8.01
18,727,040.00
5,745,000
55,954,050.00
除上文所述者外,於報告期及直至本公告日期,本公司或其任何附屬公司概無購
買、出售或贖回本公司任何上市證券(包括出售庫存股)。
於二零二六年六月三十日,就上市規則而言,本公司持有7,084,210股庫存股,該
等庫存股用於本公司股份計劃,包括二零二五年股份獎勵計劃。詳情請參閱本公
司日期分別為二零二五年一月十四日的公告及二零二五年一月十五日的通函,以
及本公司日期為二零二五年二月三日的股東特別大會投票結果公告。
董事信息變更
於報告期內,董事會並不知悉董事資料的任何變更須根據上市規則第13.51B(1)條
予以披露。
中期業績審閱
本公司的獨立核數師畢馬威會計師事務所已根據香港會計師公會頒佈的香港審閱
委聘準則第2410號「實體獨立核數師進行中期財務資料審閱」對中期財務資料進行
審閱。
審核委員會由三名獨立非執行董事組成,即顧炯先生、魏以楨博士及華林女士。
顧炯先生為審核委員會主席。審核委員會已與管理層共同審閱本公司所採納的會
計原則及政策,並討論本集團的內部監控及財務報告事宜(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)。審核委員會認為中期業績符合適
用會計準則、法律及法規,且本公司已就此作出適當披露。董事會與審核委員會
之間對會計準則的選擇、應用及詮釋、本公司採納的會計處理或報告期內管理層
編製及呈列的中期財務資料並無意見分歧。
報告期後事項
報告期後及直至本公告日期,並無重大期後事項。
37
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。
刊載中期業績及中期報告
本公告刊載於聯交所網站( www.hkexnews.hk )及本公司網站( www.ascletis.com )。
截至二零二六年六月三十日止六個月之中期報告載有上市規則所規定之全部資
料,將適時寄發予需要印刷本的股東及在聯交所及本公司網站上刊載。
致謝
董事會謹此對股東、本集團的管理團隊、僱員、業務夥伴及客戶向本集團作出之
支持及貢獻表示衷心感謝。
38
釋義
「二零二五年購股權計劃」
指
本公司於二零二五年二月三日採納的二零二
五年購股權計劃
「二零二五年股份獎勵計劃」 指
本公司於二零二五年二月三日採納的二零二
五年股份獎勵計劃
「章程細則」
指
本公司組織章程細則
「歌禮」、「公司」、
「本公司」或「我們」
指
歌禮製藥有限公司,一家於二零一四年二月
二十五日在開曼群島註冊成立的獲豁免有限
公司
「歌禮生物科技」
指
歌禮生物科技(杭州)有限公司,一家於二零
一三年四月二十六日在中國成立的有限責任
公司,為本公司的間接全資附屬公司
「歌禮製藥(中國)」
指
歌禮製藥(中國)有限公司,一家於二零一八
年三月十五日在香港註冊成立的有限責任公
司,為本公司的間接全資附屬公司
「歌禮藥業」
指
歌 禮 藥 業( 浙 江 )有 限 公 司 , 一 家 於 二 零 一
四年九月二十四日在中國成立的有限責任公
司,為本公司的間接全資附屬公司
「審核委員會」
指
董事會審核委員會
「董事會」
指
本公司董事會
「cAMP」
指
環磷酸腺苷
「企業管治守則」
指
上市規則附錄C1所載的企業管治守則
「主席」
指
董事會主席
「中國」或「中國內地」
指
中華人民共和國,就本公告而言,不包括香
港、澳門特別行政區及台灣
「董事」
指
本公司董事
「DIO」
指
飲食誘導肥胖
「吳博士」
指
吳勁梓博士,本公司創辦人、董事會主席、
行政總裁及控股股東之一,亦為何淨島女士
的配偶
39
「EMA」
指
歐洲藥品管理局
「FASN」
指
脂肪酸合成酶
「FDA」
指
美國食品藥品監督管理局
「FDC」
指
固定劑量複方製劑
「按公平值計入其他
全面收入」
指
按公平值計入其他全面收入
「按公平值計入損益」
指
按公平值計入損益
「GCGR」
指
胰高血糖素受體
「GIPR」
指
葡萄糖依賴性促胰島素多肽受體
「GLP-1R」
指
胰高血糖素樣肽-1受體
「本集團」
指
本公司及其附屬公司
「hAMY1R」
指
人胰淀素1型受體
「hCTR」
指
人降鈣素受體
「港元」
指
港元,香港法定貨幣
「香港」
指
中國香港特別行政區
「IL-17A和F」
指
白細胞介素-17A和F
「IND」
指
研究性新藥,製藥公司於藥品上市申請獲批
之前獲准經司法權區運送(通常運往臨床調查
人員)的實驗性藥品
「上市規則」
指
聯交所證券上市規則(經不時修訂或補充)
「MAA」
指
上市許可申請
「主板」
指
聯交所主板
「標準守則」
指
上市規則附錄C3 所載的上市發行人董事進行
證券交易的標準守則
「NDA」
指
新藥上市申請
「非人靈長類動物」
指
非人靈長類動物
40
「國家藥監局」
指
中國國家藥品監督管理局
「購股權」
指
根據二零二五年購股權計劃的條款向承授人
授出以認購股份的購股權
「QD」
指
每日一次
「研發」
指
研究及開發
「人民幣」
指
人民幣元,中國法定貨幣
「報告期」
指
自二零二六年一月一日起至二零二六年六月
三十日止六個月期間
「SAD」
指
單劑量遞增
「Sagimet」
指
Sagimet Biosciences Inc.,一家於二零零六
年十二月在特拉華州註冊成立的公司,其股
份於納斯達克股票交易所上市(股份代碼:
SGMT)
「SALD」
指
自組裝脂質儲庫
「股份」
指
本公司股本中每股面值0.0001美元的普通股
「股份獎勵」
指
根據二零二五年股份獎勵計劃的條款授予承
授人以認購股份的股份獎勵
「股東」
指
股份持有人
「皮下」
指
皮下
「STAT6」
指
信號轉導和轉錄激活因子6
「聯交所」
指
香港聯合交易所有限公司
「美國」
指
美利堅合眾國
「美元」
指
美利堅合眾國法定貨幣美元
「對比」
指
對比
「書面指引」
指
本公司採納的關於董事進行證券交易的指引
「%」
指
百分比
41
於本公告內,除文義另有所指外,「聯繫人」、「關連人士」、「控股股東」及「附屬
公司」等詞彙應具有上市規則賦予該等詞彙之涵義。
承董事會命
Ascletis Pharma Inc.
歌禮製藥有限公司
主席
吳勁梓
香港
二零二六年八月三十一日
於本公告日期,董事會包括執行董事吳勁梓博士及何淨島女士;及獨立非執行董
事魏以楨博士、顧炯先生及華林女士。
42
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