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]
歌礼制药-B选定同类最佳每月一次皮下注射GLP-1R/GIPR双靶点激动剂多肽 ASC35进入临床开发阶段