翰森制药(03692)肺癌新药“阿美替尼“第五项适应症申报上市

智通财经
27 Nov 2024

智通财经APP获悉,11月27日,中国国家药监局药品审评中心(CDE)网站最新公示,翰森制药(03692)第三代EGFR-TKI新药甲磺酸阿美替尼片一项新适应症上市申请获得受理。公开资料显示,这是阿美替尼片在中国提交的第五个适应症上市申请。

截图来源:CDE官网

今年10月22日,翰森制药宣布,一项阿美替尼片联合化疗作为局部晚期(IIIB-IIIC期)或转移性(IV期)EGFR突变非小细胞肺癌(NSCLC)患者的一线治疗方案的3期注册试验AENEAS2达到了其主要终点即无进展生存期(PFS)。翰森制药表示该试验的详细数据将在未来医学会议上发布及向监管机构递交。由此推测,这可能为本次阿美替尼申报上市的适应症。

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