歌禮製藥（01672.HK）自愿公告：口服胰淀素受体激动剂多肽 ASC36 获 FDA IND 批准后在美国启动肥胖症 I 期研究，为其 2026 年第四项多肽 I 期研究

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.

Ascletis Pharma Inc.
歌禮製藥有限公司

(incorporated in the Cayman Islands with limited liability)

(Stock Code: 1672)

VOLUNTARY ANNOUNCEMENT
ASCLETIS ANNOUNCES INITIATION OF PHASE I STUDY IN U.S.
FOR ORAL AMYLIN RECEPTOR PEPTIDE AGONIST ASC36 FOR THE
TREATMENT OF OBESITY
–

This trial marks the fourth Phase I peptide study for Ascletis this year.

–

ASC36 oral tablets achieved absolute oral bioavailability of 6% to 8% at steady state in
non-human primate (NHP) studies utilizing Ascletis ’ proprietary Peptide Oral Transport
ENhancement Technology (POTENT).

–

ASC36 oral tablets reduced mean body weight up to 13.2% from baseline after once-daily
dosing for seven days in NHPs.

–

ASC36 subcutaneous (SQ) injection demonstrated approximately 32% and 91% greater
relative body weight reduction compared to eloralintide and petrelintide injection,
respectively, in a head-to-head diet-induced obese (DIO) rat model.

–

ASC36 oral tablets are expected to utilize a lower dose based on potentially better oral
bioavailability and efficacy. This superior weight loss per milligram of ASC36 peptide may
also provide scalability advantages in manufacturing.

This announcement is made by Ascletis Pharma Inc. (the “Company” or “Ascletis”, together with
its subsidiaries, the “Group”) on a voluntary basis for the purpose of keeping the shareholders of
the Company and potential investors abreast of the latest business development of the Group.
The board (the “Board”) of directors (the “Directors”) of the Company announces that it has
initiated a U.S. Phase I study of ASC36 oral tablets (oral amylin receptor peptide agonist) for the
treatment of obesity after recently receiving Investigational New Drug (IND) clearance from the
U.S. Food and Drug Administration (FDA).
The Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of ASC36 following single and multiple ascending oral doses in 86 participants
with obesity (body mass index (BMI) ≥ 30.0 kg/m²) or overweight (BMI ≥ 27.0 kg/m²).

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“In 2026, we initiated four Phase I studies for our peptide pipeline, including ASC36 oral tablets,
our fourth and most recent one, which represents a key milestone for Ascletis peptide pipeline
and further validates our proprietary POTENT oral peptide delivery technology.” said Jinzi Jason
Wu, Ph.D., Founder, Chairman of the Board and chief executive officer of Ascletis, “ASC36 has
demonstrated compelling preclinical weight-loss efficacy, favorable oral bioavailability and a
prolonged half-life. We believe an effective oral amylin receptor agonist could offer a convenient,
differentiated option for people with obesity. Combined with our oral small molecule and
long-acting injectable programs, ASC36 further strengthens our diversified pipeline addressing the
evolving treatment needs of patients with obesity and other metabolic diseases.”
ASC36, an amylin receptor peptide agonist, was discovered and developed in-house utilizing
Ascletis’ proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD).
ASC36 oral tablet formulation was developed and optimized by Ascletis’ proprietary Peptide Oral
Transport ENhancement Technology (POTENT) for delivery of oral peptides.
In non-human primates (NHPs), 10 mg ASC36 oral tablet per animal dosed once daily for seven
days achieved absolute oral bioavailability[1] of 8% and elimination half-life of 116 hours at steady
state; 25 mg ASC36 oral tablet per animal dosed once daily for seven days achieved absolute oral
bioavailability of 6% and elimination half-life of 167 hours at steady state. The long elimination
half-life (116 hours to 167 hours) of ASC36 oral tablets supports once-daily and less frequent oral
dosing.
ASC36 oral tablets and subcutaneous (SQ) injection demonstrated significant weight loss in NHP
and diet-induced obese (DIO) rat models, respectively. In NHPs, ASC36 oral tablets reduced mean
body weight up to 13.2% from baseline after once-daily dosing for seven days. ASC36 tablets also
reduced food intake significantly. In a head-to-head DIO rat model, after seven days of treatment,
ASC36 SQ injection demonstrated approximately 32% and 91% greater relative body weight
reduction compared to eloralintide and petrelintide injection, respectively.
Based on potentially better oral bioavailability and efficacy, ASC36 oral tablets are expected
to utilize a lower dose, relative to a recently FDA approved oral GLP-1R peptide agonist. This
superior weight loss per milligram of ASC36 peptide may also provide scalability advantages in
manufacturing.
[1]

Absolute oral bioavailability: the percentage of an orally administered drug that reaches the
systemic circulation (bloodstream), compared to an intravenous (IV) dose of the same drug

Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of
Securities on The Stock Exchange of Hong Kong Limited: We cannot guarantee that we will be
able to ultimately develop, manufacture and/or commercialize ASC36 successfully.
By order of the Board
Ascletis Pharma Inc.
歌禮製藥有限公司
Jinzi Jason WU
Chairman
Hong Kong
September 8, 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.
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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。

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）

自願性公告
歌禮宣佈在美國啟動口服胰淀素受體激動劑多肽ASC36
治療肥胖症的I期研究
－ 該研究是歌禮今年的第四項多肽類I期研究。

－ 在非人靈長類動物研究中，通過利用歌禮專有的口服多肽遞送增強技術
(POTENT)，ASC36口服片在穩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，使平均體重相較
基線下降高達13.2%。
－ 在一項頭對頭飲食誘導肥胖(DIO)大鼠模型中，與eloralintide和petrelintide注
射劑相比，ASC36皮下注射劑實現的減重效果分別相對提升約32%和91%。
－ 基於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。ASC36多肽這一每毫克更優越的減重效果，也可能使其在規模化生產中
成本更低。
本公告乃歌禮製藥有限公司（「本公司」或「歌禮」，連同其附屬公司稱為「本集
團」）自願作出，以使本公司股東及潛在投資者了解本集團的最新業務發展。
本公司董事（「董事」）會（「董事會」）宣佈，在近期獲得美國食品藥品監督管理局
(FDA)批准新藥臨床試驗(IND)後，其已啟動ASC36口服片（口服胰淀素受體激動
劑多肽）用於治療肥胖症的美國I期研究。

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該I期研究旨在評估ASC36在86名肥胖（體重指數(BMI)≥30.0 kg/m ²）或超重（BMI
≥27.0 kg/m²）受試者中，單劑量和多劑量遞增口服給藥後的安全性、耐受性、藥代
動力學和藥效動力學。
「2026年，我們就多肽管線啟動了四項I期研究，ASC36口服片是其中第四項也是
最新的一項，這是歌禮多肽管線的一項重要里程碑，也進一步驗證了我們專有的
POTENT口服多肽遞送技術。」歌禮創始人、董事會主席兼首席執行官吳勁梓博士
表示，「ASC36 在臨床前研究中表現出令人鼓舞的減重療效、良好的口服生物利
用度和較長的半衰期。我們相信，一款有效的口服胰淀素受體激動劑有望為肥胖
人群提供便捷且差異化的治療選擇。結合我們的口服小分子和長效注射劑項目，
ASC36進一步強化了我們的多元化產品管線，以滿足肥胖症及其他代謝疾病患者
不斷變化的治療需求。」
ASC36是一款利用歌禮專有的基於結構的AI輔助藥物發現（Artificial Intelligenceassisted Structure-Based Drug Discovery，AISBDD）技術自主研發的胰淀素受體激
動劑多肽。ASC36口服片劑由歌禮利用其專有的口服多肽遞送增強技術（Peptide
Oral Transport ENhancement Technology，POTENT）開發並優化而成，該技術用
於實現口服多肽遞送。
在非人靈長類動物中，10毫克ASC36口服片在每只動物中每日一次給藥，給藥7
天後，穩態下的絕對口服生物利用度(absolute oral bioavailability)[1] 為8%，消除半
衰期(elimination half-life)達116小時；25毫克ASC36口服片在每只動物中每日一
次給藥，給藥7 天後，穩態下的絕對口服生物利用度為6%，消除半衰期達167 小
時。ASC36口服片較長的消除半衰期（116小時至167小時），為每日一次及更低頻
率的口服給藥方案提供了支持。
ASC36口服片和皮下注射劑在非人靈長類動物和飲食誘導肥胖(DIO)大鼠模型中
分別表現出了顯著的減重效果。在非人靈長類動物中，ASC36口服片每日一次給
藥7 天後，使平均體重相較基線下降高達13.2%。ASC36 片亦顯著減少了食物攝
入。在一項頭對頭DIO大鼠模型中，治療7天後，與eloralintide和petrelintide注射
劑相比，ASC36皮下注射劑實現的減重效果分別相對提升約32%和91%。
基於潛在更優的口服生物利用度和療效，與近期獲FDA批准的一款GLP-1R激動
劑多肽相比，預計ASC36 口服片的給藥劑量更低。ASC36 多肽這一每毫克更優
越的減重效果，也可能使其在規模化生產中成本更低(scalability advantages in
manufacturing)。
[1]

絕對口服生物利用度：指與靜脈給藥相比，相同藥物在以口服方式給藥後進入全身循環
（血液）的劑量百分比

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香港聯合交易所有限公司證券上市規則第18A.05條規定的警示聲明：我們無法保
證我們將能夠最終令ASC36成功開發、銷售及 ╱ 或商業化。
承董事會命
歌禮製藥有限公司
主席
吳勁梓
香港
二零二六年九月八日

於本公告日期，本公司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。

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