Core Viewpoint - The article highlights the significant advancement of Goli Pharma in the development of ASC37, a next-generation GLP-1R/GIPR/GCGR tri-agonist peptide, which is set to enter clinical trials for obesity treatment in 2026, marking a key milestone in multi-target metabolic drug development [4][6]. Group 1: Drug Development and Characteristics - ASC37 has been developed using Goli's AI-assisted drug discovery platform and ultra-long-acting drug development platform, showing enhanced agonistic activity at GLP-1R, GIPR, and GCGR receptors, approximately 5 times, 4 times, and 4 times stronger than the leading candidate retatrutide, respectively [6]. - The drug's design allows for a significant extension of its apparent half-life, supporting monthly subcutaneous administration with a single injection volume of less than 1 mL, which is expected to improve patient compliance and reduce manufacturing costs [6][7]. - In non-human primate studies, ASC37 demonstrated an average apparent half-life of about 17 days, which is 7 times longer than that of retatrutide, indicating superior in vivo exposure maintenance capabilities [7]. Group 2: Therapeutic Applications and Combination Strategies - ASC37 is being developed for single-agent and combination therapies targeting obesity, diabetes, and metabolic dysfunction-related fatty liver disease (MASH), addressing high-burden chronic diseases [7]. - Goli plans to explore the synergistic effects of ASC37 in combination with another monthly subcutaneous amylin receptor agonist peptide, ASC36, aligning with the global trend of integrating multiple pathways in metabolic drug development [7]. Group 3: Technological Platforms and Industry Position - The AISBDD and ULAP platforms are foundational to Goli's continuous output of peptide pipelines, allowing for the design of various release rates for subcutaneous depot peptides, achieving a better balance between efficacy, safety, and patient experience [8]. - The advancement of ASC37 reflects the shift of Chinese innovative pharmaceutical companies from imitation to competitive participation in global markets, particularly in drug frequency, pharmacokinetics, and system engineering [8].

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- ...