信达生物涨超3% 口服小分子GLP-1R激动剂IBI3032的IND获美国FDA批准
Zhi Tong Cai Jing·2025-08-05 01:54

Core Viewpoint - The stock of Innovent Biologics (01801) rose over 3% following the announcement of FDA approval for its innovative oral small molecule GLP-1R agonist IBI3032, indicating positive market sentiment towards the company's advancements in drug development [1] Group 1: Company Developments - Innovent Biologics announced that its oral small molecule GLP-1R agonist IBI3032 received IND approval from the FDA on August 5 [1] - IBI3032 is designed to preferentially activate the cAMP signaling pathway and is based on a globally validated molecular framework with complete independent intellectual property rights [1] - The Phase I clinical trial for IBI3032 will be conducted simultaneously in China and the United States, starting in the second half of 2025, involving healthy subjects and individuals who are overweight or obese [1] Group 2: Market Impact - Following the announcement, Innovent Biologics' stock price increased by 3.12%, reaching HKD 95.8, with a trading volume of HKD 219 million [1] - The initiation of clinical research for IBI3032 is considered a significant step in the evolution of the company's metabolic product matrix, leveraging the foundation of the drug Masitide [1] - The IND application for IBI3032 has also been accepted by the National Medical Products Administration (NMPA) in China, indicating a strong regulatory pathway for the drug [1]