Core Insights - The company has selected its first oral glucagon-like peptide-1 (GLP-1) receptor agonist, ASC36 oral tablets, for clinical development, with plans to submit an Investigational New Drug (IND) application to the FDA in Q2 2026 [1] Group 1: Drug Development - ASC36 oral tablets are developed using the proprietary oral peptide delivery enhancement technology (POTENT) [1] - In non-human primates, the absolute oral bioavailability of ASC36 was 8% for the 10 mg dose and 6% for the 25 mg dose, with elimination half-lives of 116 hours and 167 hours respectively, supporting once-daily dosing [1][2] - ASC36 demonstrated significant weight loss effects in both non-human primates and diet-induced obesity (DIO) rat models, achieving up to a 13.2% reduction in average body weight relative to baseline after 7 days of treatment [2] Group 2: Competitive Advantage - In head-to-head comparisons with other GLP-1 receptor agonists, ASC36 achieved weight loss effects that were approximately 32% and 91% better than eloralintide and petrelintide respectively [2] - The potential for superior oral bioavailability and efficacy may allow for lower dosing of ASC36 compared to recently FDA-approved GLP-1R agonists, which could lead to cost advantages in manufacturing [2] - The company has developed ASC36 using its Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) technology, contributing to a competitive and diversified product pipeline aimed at addressing diverse treatment needs for obesity and other metabolic diseases [3]
歌礼制药-B：选定口服胰淀素受体激动剂多肽ASC36进行临床开发