歌礼制药-B(01672)：选定口服胰淀素受体激动剂多肽ASC36进行临床开发

Core Viewpoint - The company, Gilead Sciences, has announced the selection of its first oral glucagon-like peptide-1 (GLP-1) receptor agonist, ASC36, for clinical development, with plans to submit an Investigational New Drug (IND) application to the FDA by Q2 2026 [1] Group 1: Drug Development and Clinical Trials - ASC36 oral tablets are developed using Gilead's proprietary oral peptide delivery enhancement technology (POTENT) [1] - The absolute oral bioavailability of ASC36 in non-human primates is 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 less frequent dosing [1][2] - The drug has shown 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: Comparative Efficacy and Manufacturing Advantages - ASC36 demonstrated approximately 32% and 91% greater weight loss compared to eloralintide and petrelintide, respectively, in head-to-head DIO rat models [2] - The potential for superior oral bioavailability and efficacy may allow for lower dosing compared to recently FDA-approved GLP-1R agonists, which could lead to cost advantages in large-scale production [2] - ASC36 is part of a broader pipeline of insulin candidates, including oral small molecule insulin and monthly subcutaneous insulin peptides, leveraging Gilead's three proprietary technology platforms: AI-assisted structure-based drug discovery (AISBDD), ultra-long-acting drug development platform (ULAP), and POTENT [3]