整理 | GLP1减重宝典内容团队 「GLP-1俱乐部」覆盖数百位专业人士，构建了围绕GLP-1产业链上下游、覆盖多个板块的专家库，成为了业内顶尖专业人士获取行业真知灼见的首要选择。加入 专家库请添加下方「运营负责人」微信，并提供名片和必要的个人信息。 2025年10月30日，歌礼制药有限公司(香港联交所代码：1672，简称"歌礼")宣布，已选定一款有望成为同类最佳每月一次皮下注射胰淀 素(amylin)受体激动剂ASC36作为临床开发候选药物。歌礼预计将于2026年第二季度向美国食品药品监督管理局(FDA)递交ASC36治疗 肥胖症的新药临床试验申请(IND)。 ASC36是利用歌礼基于结构的AI辅助药物发现(Artificial Intelligence-Assisted Structure-Based Drug Discovery，AISBDD)和超长效药 物开发平台(Ultra-Long-Acting Platform，ULAP)技术自主研发的胰淀素受体激动剂多肽。经设计优化的ASC36实现了更长的表观半衰 期(以血药浓度降至Cmax的50%所需时间计)及更高的每毫克多肽生物利用度，从而支持每月一次皮 ...

消息面上，歌礼制药公布，已选定一款有望成为同类最佳每月一 次皮下注射胰淀素(amylin)受体激动剂 ASC36作为临床开发候选药物。歌礼预计将于2026年第二季度向美国食品药品监督管理局(FDA)递交 ASC36治疗肥胖症的新药临床试验申请(IND)。 智通财经APP获悉，歌礼制药-B(01672)现涨超4%，截至发稿，涨4.62%，报9.74港元，成交额1281.4万 港元。 据悉，ASC36是利用歌礼基于结构的AI辅助药物发现和超长效药物开发平台技术自主研发的胰淀素受体 激动剂多肽。经设计优化的ASC36实现更长的表观半衰期(以血药浓度降至Cmax的50%所需时间计)及更 高的每毫克多肽生物利用度，从而支持每月一次皮下给药，且注射体积不超过1毫升。这些经设计优化 的特性使其在规模化生产中成本更低。 ...

Core Insights - The company has selected ASC36 as a clinical development candidate, which is expected to be a best-in-class monthly subcutaneous injection amylin receptor agonist for obesity treatment [1][2] - ASC36 is developed using the company's AI-assisted drug discovery and ultra-long-acting drug development platforms, featuring optimized properties for longer half-life and higher bioavailability [1] - The company plans to submit an Investigational New Drug (IND) application to the FDA in Q2 2026 [1] Drug Development and Efficacy - ASC36 has an observed half-life of approximately 15 days in non-human primate studies, which is three times longer than petrelintide, supporting the potential for monthly dosing in humans [2] - In diet-induced obesity rat studies, ASC36 demonstrated a weight reduction of 10.01%, compared to 5.25% for petrelintide, indicating a 91% relative improvement in weight loss efficacy [2] - The optimized characteristics of ASC36 may lead to lower manufacturing costs and improved dosing regimens for patients [2]

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]

Core Viewpoint - The company has selected ASC36 as a promising candidate for clinical development, expected to be submitted for FDA approval in Q2 2026 for obesity treatment [1] Group 1: Product Development - ASC36 is an amylin receptor agonist developed using AI-assisted structure-based drug discovery and ultra-long-acting platform technologies [1] - The optimized design of ASC36 allows for a longer apparent half-life and higher bioavailability per milligram, supporting monthly subcutaneous administration with a volume not exceeding 1 milliliter [1] - The scalability advantages in manufacturing are highlighted, indicating lower production costs for ASC36 [1] Group 2: Clinical Research Findings - 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, supporting its potential for monthly dosing in humans [2] - In diet-induced obesity rat studies, ASC36 achieved a weight reduction of 10.01%, compared to 5.25% for petrelintide, indicating a relative improvement of 91% in weight loss effectiveness [2] - The superior weight loss effect per milligram of peptide may further enhance the cost-effectiveness of ASC36 in large-scale production [2]

Core Insights - Ascletis Pharma Inc. has selected ASC36 as a clinical development candidate for obesity treatment, with an Investigational New Drug Application (IND) submission expected in Q2 2026 [3][4][7] Group 1: Drug Development and Efficacy - ASC36 is a once-monthly, subcutaneously administered amylin receptor agonist, demonstrating a half-life of approximately 15 days in non-human primate studies, which is three times longer than petrelintide [1][4] - In a diet-induced obese rat study, ASC36 achieved a body weight reduction of 10.01%, compared to 5.25% for petrelintide, indicating a 91% greater relative efficacy [5][6] - The drug's formulation allows for co-formulation with other peptides, such as ASC35, enhancing its therapeutic potential [2][7] Group 2: Technological Advancements - ASC36 was developed using Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies, which facilitate the design of ultra-long-acting peptides [4][9] - The engineered properties of ASC36 support scalability advantages in manufacturing, contributing to its potential as a best-in-class treatment for obesity [5][7] Group 3: Company Strategy and Future Plans - Ascletis aims to develop ASC36 as a cornerstone therapy for cardio-metabolic diseases, with plans for combination therapies involving ASC35 [8] - A conference call is scheduled for October 30, 2025, to discuss further developments [10]

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 article discusses the development of ASC35, a novel GLP-1/GIP receptor dual agonist by the company, which is expected to enhance patient compliance and reduce production costs due to its long-acting formulation and improved pharmacokinetics [4][5]. Group 1: Drug Development and Characteristics - ASC35 is a monthly subcutaneous injection candidate for obesity treatment, with an IND application planned for submission to the FDA in 2026 [4]. - The drug shows approximately 4 times higher activity on GLP-1R and GIPR compared to Tirzepatide in vitro [4]. - ASC35 has a longer half-life and higher bioavailability, requiring only 1 milliliter or less for administration, which supports monthly dosing [4]. Group 2: Pharmacokinetics and Efficacy - In non-human primate studies, ASC35's average half-life is about 14 days, which is 6 times longer than that of Tirzepatide [5]. - Drug exposure (measured by AUC) shows ASC35 has approximately 80% higher exposure via intravenous injection and 70% higher via subcutaneous injection compared to Tirzepatide [5]. - The estimated half-life of ASC35 in humans could reach 30 days or longer, supporting its monthly dosing feasibility [5]. Group 3: Weight Loss Efficacy - In a diet-induced obesity mouse model, ASC35 led to a weight reduction of 33.6% at equimolar doses, compared to 19.6% for Tirzepatide, representing a 71% relative efficacy improvement [7]. - The higher weight loss efficiency per milligram of peptide is advantageous for large-scale production [7]. Group 4: Combination Therapy Potential - The company plans to explore ASC35 as both a monotherapy and in combination with other candidates for treating various cardiometabolic diseases, including obesity and diabetes [8]. - Potential combination therapies include ASC36, a GLP-1 receptor agonist, and ASC47, a THRβ agonist, both designed for monthly subcutaneous administration [8]. - The company utilizes its AISBDD and ULAP technology platforms to design and optimize long-acting peptide drugs, aiming to improve clinical efficacy by controlling subcutaneous release rates [8].