Core Viewpoint - The approval of the IND for ASC30 by the FDA marks a significant milestone for the company, potentially enhancing its market position in the diabetes treatment sector [1] Group 1: Company Developments - The stock price of Gilead Sciences-B (01672) increased by over 5%, reaching HKD 12.12 with a trading volume of HKD 2.7083 million [1] - On January 5, Gilead Sciences-B announced the FDA's approval for its oral small molecule GLP-1, ASC30, for a Phase II clinical trial in diabetic patients [1] - ASC30 is the first and only small molecule GLP-1 receptor agonist in clinical research that can be administered either orally once daily or via subcutaneous injection monthly to quarterly [1] Group 2: Clinical Trial Details - The Phase II study is a 13-week, randomized, double-blind, placebo-controlled, multi-center trial aimed at evaluating the efficacy, safety, and tolerability of ASC30 in Type 2 diabetes patients [1] - The primary endpoint of the Phase II study is the average change in glycated hemoglobin (HbA1c) from baseline at 13 weeks, comparing the treatment group to the placebo group [1]
港股异动 歌礼制药-B(01672)涨超5% 近期已获FDA批准开展ASC30在糖尿病受试者中的II期研究