贝达药业：盐酸恩沙替尼胶囊欧洲上市许可申请获EMA受理

Group 1 - The core point of the article is that Xcovery Holdings, a subsidiary of Betta Pharmaceuticals, has submitted a marketing authorization application for ensartinib capsules to the European Medicines Agency (EMA) for the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients [1] - The drug is a novel, potent, and highly selective ALK inhibitor that has already been approved for second-line and first-line indications in China [1] - The FDA is expected to approve the drug for market launch in the United States by December 2024, and the EMA has officially accepted the application for marketing authorization [1]