贝达药业(300558.SZ):盐酸恩沙替尼胶囊上市许可申请获得欧洲药品管理局受理
Betta Pharmaceuticals Co., Ltd.Betta Pharmaceuticals Co., Ltd.(SZ:300558) 智通财经网·2025-11-28 07:57

Core Viewpoint - The announcement indicates that Xcovery, a subsidiary of BeiGene, has received acceptance from the European Medicines Agency (EMA) for the marketing authorization application of ensartinib capsules for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients [1] Group 1 - Xcovery submitted a marketing authorization application for ensartinib to the EMA [1] - Ensartinib is a new generation ALK inhibitor that is highly selective and potent [1] - The drug was previously approved by the National Medical Products Administration (NMPA) in China for second-line treatment in November 2020 and for first-line treatment in March 2022 [1]

Betta Pharmaceuticals Co., Ltd.-贝达药业(300558.SZ):盐酸恩沙替尼胶囊上市许可申请获得欧洲药品管理局受理 - Reportify