信达生物小分子GLP-1R激动剂在中国获批临床

药渡
Aug 24, 2025

中国国家药监局药品审评中心(CDE)官网近日公示,信达生物申报的1类新药IBI3032获得临床试验默示许可,拟用于成人超重或肥胖患者的长期体重控制。公开资料显示,这是信达生物研发的创新口服小分子GLP-1R激动剂,已经于今年8月初在美国获批IND。IBI3032的1期临床试验将在中美同步推进,将于2025年下半年开始在健康受试者及超重或肥胖人群中给药。IBI3032是一种新型口服小分子胰高血糖素...

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