歌礼制药-B(01672)发布公告，公司董事会宣布其口服小分子GLP-1受体(GLP-1R)激动剂ASC30治疗2型 糖尿病的美国13周II期研究(NCT07321678)已完成首批受试者给药。预计将于2026年第三季度获得该项II 期研究的顶线数据。 由歌礼自主研发的ASC30是首款也是唯一一款正在临床研究中的、既可每日一次口服也可每月一次至每 季度一次皮下注射的小分子GLP-1R完全偏向激动剂，用于肥胖症、糖尿病及其它代谢疾病的治疗。 "将ASC30的临床开发拓展至庞大的糖尿病治疗市场，是合乎逻辑的下一步战略，为我们提供了另一个 机遇，以彰显ASC30有望为患者提供同类最佳每日一次口服疗法选择。"歌礼创始人、董事会主席兼首 席执行官吴劲梓博士表示，"我们期待在2026年第三季度分享在糖尿病受试者中开展的II期研究的顶线 数据。" 歌礼已于近期完成一项评估ASC30治疗肥胖症的13周II期研究(NCT07002905)。该研究在美国多个中心 开展，共入组125例肥胖受试者或伴有至少一种体重相关合并症的超重受试者。在第13周的主要终点 上，每日一次20毫克、40毫克和60毫克ASC30片分别实现了5.4%、7 ...

智通财经APP讯，歌礼制药-B(01672)发布公告，公司董事会宣布其口服小分子GLP-1受体(GLP-1R)激动 剂ASC30治疗2型糖尿病的美国13周II期研究(NCT07321678)已完成首批受试者给药。预计将于2026年第 三季度获得该项II期研究的顶线数据。 由歌礼自主研发的ASC30是首款也是唯一一款正在临床研究中的、既可每日一次口服也可每月一次至每 季度一次皮下注射的小分子GLP-1R完全偏向激动剂，用于肥胖症、糖尿病及其它代谢疾病的治疗。 "将ASC30的临床开发拓展至庞大的糖尿病治疗市场，是合乎逻辑的下一步战略，为我们提供了另一个 机遇，以彰显ASC30有望为患者提供同类最佳每日一次口服疗法选择。"歌礼创始人、董事会主席兼首 席执行官吴劲梓博士表示，"我们期待在2026年第三季度分享在糖尿病受试者中开展的II期研究的顶线 数据。" 歌礼已于近期完成一项评估ASC30治疗肥胖症的13周II期研究(NCT07002905)。该研究在美国多个中心 开展，共入组125例肥胖受试者或伴有至少一种体重相关合并症的超重受试者。在第13周的主要终点 上，每日一次20毫克、40毫克和60毫克ASC30片分别 ...

由歌礼自主研发的ASC30是首款也是唯一一款正在临床研究中的、既可每日一次口服也可每月一次至每 季度一次皮下注射的小分子GLP-1R完全偏向激动剂，用于肥胖症、糖尿病及其它代谢疾病的治疗。 "将ASC30的临床开发拓展至庞大的糖尿病治疗市场，是合乎逻辑的下一步战略，为我们提供了另一个 机遇，以彰显ASC30有望为患者提供同类最佳每日一次口服疗法选择。"歌礼创始人、董事会主席兼首 席执行官吴劲梓博士表示，"我们期待在2026年第三季度分享在糖尿病受试者中开展的II期研究的顶线 数据。" 格隆汇1月26日丨歌礼制药-B(01672.HK)发布公告，其口服小分子GLP-1受体(GLP-1R)激动剂ASC30治 疗2型糖尿病的美国13周II期研究(NCT07321678)已完成首批受试者给药。预计将于2026年第三季度获得 该项II期研究的顶线数据。 歌礼已于近期完成一项评估ASC30治疗肥胖症的13周II期研究(NCT07002905)。该研究在美国多个中心 开展，共入组125例肥胖受试者或伴有至少一种体重相关合并症的超重受试者。在第13周的主要终点 上，每日一次20毫克、40毫克和60毫克ASC30片分别实现了5 ...

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） 歌禮已於近期完成一項評估ASC30治療肥胖症的13周II期研究(NCT07002905)。 該研究在美國多個中心開展，共入組125例肥胖受試者或伴有至少一種體重相關 合併症的超重受試者。在第13周的主要終點上，每日一次20毫克、40毫克和60毫 克ASC30片分別實現了5.4%、7.0%和7.7%的經安慰劑校正後平均體重下降，體 重下降具有統計學顯著性、臨床意義且呈劑量依賴性。未觀察到減重平台期。每 周滴定直至目標劑量的ASC30的嘔吐發生率約為已公布的每周滴定的orforglipron 中觀察到的嘔吐發生率的一半。每周滴定的ASC30的胃腸道耐受性與已公布的 orforglipron在III期ATTAIN-1研究中每四周滴定(titrated every four weeks)的結果 相當。在ASC30用於治 ...

Core Viewpoint - The company has selected ASC37, a next-generation monthly subcutaneous injection targeting GLP-1R, GIPR, and GCGR, as a clinical development candidate for obesity treatment, with plans to submit an IND to the FDA in Q2 2026 [1] Group 1: Product Development - ASC37 is developed using the company's AI-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies, showing approximately 5 times, 4 times, and 4 times stronger agonistic activity on GLP-1R, GIPR, and GCGR compared to retatrutide [2] - The designed optimization of ASC37 allows for a longer observed half-life, supporting monthly subcutaneous administration with an injection volume not exceeding 1 milliliter, which also provides scalability advantages in manufacturing [2] - In non-human primate studies, ASC37's proprietary depot formulation has an average observed half-life of about 17 days, which is 7 times longer than that of retatrutide in standard liquid formulation [2] Group 2: Clinical Strategy - The company aims to advance ASC37 into clinical trials, with the Phase I study expected to commence in the second half of 2026, as part of a broader strategy to improve treatment options for obesity [3] - ASC37 is being developed as both a monotherapy and in combination therapies for cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-associated steatotic liver disease (MASH) [3] - The company plans to combine ASC37 with its monthly subcutaneous amylin receptor agonist peptide ASC36 to treat obesity, diabetes, and other metabolic diseases [3] Group 3: Technological Advantages - The company's AISBDD and ULAP technologies enable the design, optimization, and development of multiple long-acting peptides for monthly subcutaneous injection, including ASC35, ASC36, and ASC37 [3] - The proprietary ULAP technology allows for the design of various release rate constants for peptides in subcutaneous depots, facilitating precise release of injected peptides within predetermined dosing intervals, thereby improving clinical efficacy [3]

Core Viewpoint - The company has selected ASC37, a next-generation monthly subcutaneous injection targeting GLP-1R, GIPR, and GCGR, as a clinical development candidate for obesity treatment, with plans to submit an IND to the FDA in Q2 2026 [1] Group 1: Product Development - ASC37 is developed using the company's AI-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies, showing approximately 5 times, 4 times, and 4 times stronger agonistic activity on GLP-1R, GIPR, and GCGR compared to retatrutide [2] - The designed optimization of ASC37 allows for a longer observed half-life, supporting monthly subcutaneous administration with an injection volume not exceeding 1 milliliter, which also provides scalability advantages in manufacturing [2] - In non-human primate studies, ASC37's proprietary depot formulation has an average observed half-life of about 17 days, which is 7 times that of retatrutide in standard liquid formulation [2] Group 2: Clinical Strategy - The company aims to advance ASC37 into clinical trials, with Phase I expected to start in the second half of 2026, as part of a broader strategy to improve treatment options for obesity [3] - ASC37 is being developed as both a monotherapy and in combination therapies for cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-related fatty liver disease (MASH) [3] - The company plans to combine ASC37 with its monthly subcutaneous amylin receptor agonist peptide ASC36 to treat obesity, diabetes, and other metabolic diseases [3]

Group 1 - Company Gilead Sciences-B (01672.HK) has selected ASC37, a next-generation subcutaneous injection for monthly administration targeting GLP-1R, GIPR, and GCGR, as a clinical development candidate [1] - The company plans to submit an Investigational New Drug (IND) application for ASC37 for the treatment of obesity to the FDA in the second quarter of 2026 [1] - ASC37 is developed using Gilead's AI-assisted structure-based drug discovery and ultra-long-acting platform technologies, showing significantly higher agonistic activity compared to retatrutide [2] Group 2 - In vitro studies indicate that ASC37 exhibits approximately 5 times, 4 times, and 4 times stronger agonistic activity on GLP-1R, GIPR, and GCGR, respectively, compared to retatrutide [2] - ASC37 has a longer observed half-life, allowing for monthly subcutaneous administration with an injection volume not exceeding 1 milliliter, which also provides scalability advantages in manufacturing [2] - The proprietary depot formulation of ASC37 has an average observed half-life of about 17 days in non-human primates, which is 7 times longer than that of retatrutide in standard liquid formulation [2] Group 3 - The advantages of ASC37 in terms of agonistic activity and observed half-life suggest its potential as a new generation therapy for obesity [3] - The company is advancing ASC37 into clinical stages, with Phase I studies expected to commence in the second half of 2026, marking a significant step towards improving treatment options for the obese population [3]

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 歌禮選定新一代每月一次皮下注射GLP-1R/GIPR/GCGR 三靶點激動劑多肽ASC37進行臨床開發 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」）宣布其已選定新一代每月一次皮下給藥的 GLP-1R/GIPR/GCGR[1]三靶點激動劑多肽ASC37注射劑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ASC37注射 劑治療肥胖症的新藥臨床試驗申請(IND)。 ASC37是一款利用歌禮基於結構的AI輔助藥物發現（Artificial Intelligence-assisted Structure- ...

消息面上，歌礼制药此前公布其口服GLP-1药物ASC30用于治疗肥胖症的美国IIa期研究正向数据。花旗 发布研报称，这些数据进一步展现了ASC30同类最佳的潜力，并增强了未来合作信心。预期股价将有正 面反应；重申"买入/高风险"评级，目标价32港元。 东方证券则表示，ASC30减重数据优越，安全性良好，且分子专利已获美国授权，BD潜力较大。此 外，歌礼基于超长效药物开发平台（ULAP）开发的用于减重和维持治疗的ASC30皮下注射剂型，表观 半衰期分别长达46天和75天，远超其他超长效GLP-1药物，同时安全性占优。 歌礼制药-B(01672)午前拉升逾5%，截至发稿，涨5.12%，报13.56港元，成交额1328.47万港元。 ...

Core Viewpoint - Gilead Sciences-B (01672) experienced a significant stock increase of over 5%, reaching HKD 13.56, following positive data from its oral GLP-1 drug ASC30 for obesity treatment in a Phase IIa study in the U.S. [1] Group 1: Company Performance - Gilead's stock rose by 5.12%, with a trading volume of HKD 13.28 million [1] - Citigroup released a report indicating that the data from ASC30 demonstrates its potential as a best-in-class treatment, enhancing confidence in future collaborations [1] - The target price set by Citigroup is HKD 32, maintaining a "Buy/High Risk" rating [1] Group 2: Drug Development Insights - Oriental Securities noted that ASC30 shows superior weight loss data and good safety, with molecular patents already authorized in the U.S., indicating significant business development potential [1] - The subcutaneous formulation of ASC30, developed on Gilead's Ultra-Long-Acting Platform (ULAP), has a half-life of 46 days and 75 days for weight loss and maintenance treatment, respectively, surpassing other long-acting GLP-1 drugs while maintaining superior safety [1]