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中国生物制药(01177.HK)新药申请获FDA受理
阿思达克 02-03 16:49

中国生物制药(01177.HK)公布,附属自主研发的治疗纤维化创新药「TDI01」已向美国食品药品监督管理局(FDA)提交试验用新药申请并获得受理。获得FDA的正式批准後,集团将在美国开展TDI01的临床试验。

公告指,TDI01是全新靶点、高选择性的Rho/Rho相关卷曲螺旋形成蛋白激(酉每)2(ROCK2)抑制剂,目前开展临床试验的适应症为非酒精性脂肪肝炎、肺纤维化。

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