Core Insights - The company has selected ASC36 as a promising monthly subcutaneous injection amylin receptor agonist for clinical development, with plans to submit an IND to the FDA by Q2 2026 [1] Group 1: Product Development - ASC36 is developed using the company's AI-assisted structure-based drug discovery and ultra-long-acting platform technologies, achieving a longer apparent half-life and higher bioavailability per milligram of peptide [1] - The optimized characteristics of ASC36 support monthly subcutaneous administration with an injection volume not exceeding 1 milliliter, leading to cost advantages in manufacturing [1] Group 2: Clinical Research - In head-to-head studies with non-human primates, ASC36 demonstrated an average observed half-life of approximately 15 days, three times longer than petrelintide, indicating potential for monthly dosing in humans [2] - In diet-induced obesity rat studies, ASC36 resulted in a weight reduction of 10.01%, compared to 5.25% for petrelintide, representing a 91% relative improvement in weight loss efficacy [2]

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 歌禮選定同類最佳每月一次皮下注射胰淀素受體激動劑 ASC36進入臨床開發階段 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，已選定一款有望成為同類最佳每月一 次皮下注射胰淀素(amylin)受體激動劑ASC36作為臨床開發候選藥物。歌禮預計 將於2026年第二季度向美國食品藥品監督管理局(FDA)遞交ASC36治療肥胖症的 新藥臨床試驗申請(IND)。 | 組別 | 給藥方案 | 相對基線的 | 較petrelintide的 | | --- | --- | --- | --- | | | | 總體重變化 | 減重效果相對提升 | | 服 ...

Core Viewpoint - The company has selected ASC35, a dual-target GLP-1R/GIPR agonist, as a clinical development candidate, expected to submit an IND application to the FDA by Q2 2026 for obesity treatment [1] Group 1: Drug Development and Characteristics - ASC35 is developed using the company's AI-assisted structure-based drug discovery and ultra-long-acting drug development platforms, showing approximately 4 times stronger agonistic activity on GLP-1R and GIPR compared to Tirzepatide [2] - ASC35 has a longer apparent half-life and higher bioavailability per milligram compared to Tirzepatide, allowing for monthly subcutaneous administration with a volume not exceeding 1 milliliter [2] - In non-human primate studies, ASC35's observed half-life is about 14 days, which is 6 times longer than that of FDA-approved Tirzepatide, indicating a potential human half-life of at least 30 days [3] Group 2: Efficacy and Comparative Studies - In diet-induced obesity mouse studies, ASC35 achieved a weight reduction of 33.6%, compared to 19.6% for Tirzepatide, representing a 71% relative improvement in weight loss [4][5] - ASC35 demonstrates superior in vitro agonistic activity, apparent half-life, subcutaneous bioavailability, and weight loss effects compared to Tirzepatide, suggesting it may become a best-in-class obesity therapy [5] Group 3: Strategic Development Plans - The company plans to develop ASC35 as a monotherapy and in combination with other agents for treating metabolic diseases, including obesity and diabetes [6] - ASC35 is intended to be combined with ASC36, an amylin receptor agonist, and ASC47, a THRβ agonist, for treating obesity and metabolic dysfunction-related fatty liver disease [6][7] - The proprietary ULAP technology allows the company to design various release rates for subcutaneous peptides, enhancing clinical efficacy and patient compliance [7]

Core Viewpoint - The company has selected ASC35, a potential best-in-class monthly subcutaneous injection GLP-1R/GIPR dual agonist peptide, as a clinical development candidate, with plans to submit an IND to the FDA by Q2 2026 for obesity treatment [1]. Group 1: Product Development - ASC35 is developed using the company's AI-assisted structure-based drug discovery (AISBDD) and ultra-long-acting platform (ULAP) technologies, showing approximately 4 times stronger agonistic activity on GLP-1R and GIPR compared to Tirzepatide [2]. - ASC35 has a longer apparent half-life and higher bioavailability per milligram compared to Tirzepatide, enabling monthly subcutaneous administration with a volume not exceeding 1 milliliter, which also supports cost-effective large-scale production [2]. Group 2: Preclinical Data - In non-human primate studies, ASC35's depot formulation has an average observed half-life of about 14 days, which is 6 times longer than that of FDA-approved Tirzepatide [3]. - ASC35 demonstrated approximately 80% and 70% higher drug exposure compared to Tirzepatide via intravenous and subcutaneous administration, respectively, suggesting a potential human half-life of at least 30 days based on preclinical data [3]. - In diet-induced obesity (DIO) mouse studies, ASC35 resulted in a weight reduction of 33.6%, compared to 19.6% for Tirzepatide, indicating a relative improvement of 71% in weight loss efficacy [4][5]. Group 3: Strategic Vision - The development of ASC35 reflects the company's commitment to innovation and complements its small molecule drug pipeline for treating obesity and other metabolic diseases [6]. - ASC35 is being developed as both a monotherapy and in combination with other agents, including ASC36 and ASC47, for treating obesity, diabetes, and metabolic dysfunction-related fatty liver disease [6]. Group 4: Technological Advantages - The company's AISBDD and ULAP technologies allow for the design and optimization of multiple long-acting peptides for monthly subcutaneous injection, enhancing clinical efficacy by precisely controlling the release rates of the peptides [7].

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. 1 － 在頭對頭非人靈長類動物研究中，ASC35 的平均表觀半衰期(observed half-life)約為14天，比替爾泊肽長6倍，支持在人體中每月一次皮下給藥。 － 在頭對頭非人靈長類動物研究中，ASC35靜脈注射和皮下注射後的藥物暴露 量比替爾泊肽靜脈注射和皮下注射分別高約80%和70%。 歌禮製藥有限公司 － 體外實驗顯示，ASC35對GLP-1受體(GLP-1R)和GIP受體(GIPR)的激動活性 比替爾泊肽強約4倍。 － 在頭對頭飲食誘導肥胖(DIO)小鼠研究中，ASC35的減重效果較替爾泊肽相對 提升約71%。 － 預計將於2026年第二季度向美國食品藥品監督管理局(FDA)遞交ASC35新藥 臨床試驗申請(IND)。 （於開曼群島註冊成立的有限公司） （股份代號：1672） 自願性公告 歌禮選定同類最佳每月一次皮下注射GLP-1R/GIPR雙靶 ...