Core Viewpoint - The company has selected ASC35, a potential best-in-class monthly subcutaneous injection GLP-1R/GIPR dual agonist peptide, as a clinical development candidate, with plans to submit an IND to the FDA by Q2 2026 for obesity treatment [1]. Group 1: Product Development - ASC35 is developed using the company's AI-assisted structure-based drug discovery (AISBDD) and ultra-long-acting platform (ULAP) technologies, 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, enabling monthly subcutaneous administration with a volume not exceeding 1 milliliter, which also supports cost-effective large-scale production [2]. Group 2: Preclinical Data - In non-human primate studies, ASC35's depot formulation has an average observed half-life of about 14 days, which is 6 times longer than that of FDA-approved Tirzepatide [3]. - ASC35 demonstrated approximately 80% and 70% higher drug exposure compared to Tirzepatide via intravenous and subcutaneous administration, respectively, suggesting a potential human half-life of at least 30 days based on preclinical data [3]. - In diet-induced obesity (DIO) mouse studies, ASC35 resulted in a weight reduction of 33.6%, compared to 19.6% for Tirzepatide, indicating a relative improvement of 71% in weight loss efficacy [4][5]. Group 3: Strategic Vision - The development of ASC35 reflects the company's commitment to innovation and complements its small molecule drug pipeline for treating obesity and other metabolic diseases [6]. - ASC35 is being developed as both a monotherapy and in combination with other agents, including ASC36 and ASC47, for treating obesity, diabetes, and metabolic dysfunction-related fatty liver disease [6]. Group 4: Technological Advantages - The company's AISBDD and ULAP technologies allow for the design and optimization of multiple long-acting peptides for monthly subcutaneous injection, enhancing clinical efficacy by precisely controlling the release rates of the peptides [7].
歌礼制药-B(01672)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