贝达药业(300558.SZ)：盐酸恩沙替尼胶囊上市许可申请获美国FDA受理

智通财经03-12

智通财经APP讯，贝达药业(300558.SZ)公告，公司控股子公司Xcovery Holdings,Inc.(简称“Xcovery”)收到美国食品药品监督管理局(简称“美国FDA”)的信件，美国FDA已完成有关盐酸恩沙替尼胶囊(商品名：贝美纳®，简称“恩沙替尼”)“拟用于间变性淋巴瘤激酶(ALK)阳性的局部晚期或转移性非小细胞肺癌(NSCLC)患者的治疗”(即一线适应症)上市许可申请相关申报文件...

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