歌礼制药-B：歌礼选定新一代每月一次皮下注射GLP-1R/GIPR/GCGR 三靶点激动剂多肽ASC37进行临床开发

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]