速递|歌礼制药Amylin减肥新药向FDA申报!进入临床开发阶段
GLP1减重宝典·2025-10-31 09:55

Core Viewpoint - The article discusses the development of ASC36, a novel amylin receptor agonist by the company, which is expected to be a leading candidate for obesity treatment with a monthly subcutaneous injection regimen. The company plans to submit an IND application to the FDA in the second quarter of 2026 [5]. Group 1: Product Development - ASC36 is developed using AI-assisted structure-based drug discovery and ultra-long-acting drug development platforms, resulting in a longer apparent half-life and higher bioavailability per milligram of peptide, supporting monthly administration [5][6]. - The optimized characteristics of ASC36 lead to lower production costs, making it a competitive option in the market [6]. Group 2: Efficacy Studies - In head-to-head studies with diet-induced obesity (DIO) rats, ASC36 demonstrated a weight loss of 10.01%, compared to 5.25% for petrelintide, indicating a 91% relative improvement in weight loss efficacy [7]. - The superior weight loss effect per milligram of peptide may further enhance ASC36's cost-effectiveness in large-scale production [7].