中国生物制药公告集团与勃林格殷格翰在中国大陆联合推广的宗艾替尼片(商品名:圣赫途 )已获得中国国家药品监督管理局的上市批

智通财经
Aug 29, 2025
中国生物制药公告集团与勃林格殷格翰在中国大陆联合推广的宗艾替尼片(商品名:圣赫途 )已获得中国国家药品监督管理局的上市批准用于治疗存在HER2(ERBB2)激活突变且既往接受过至少一种系统治疗的不可切除的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者。圣赫途 是全球首个且目前唯一的口服HER2酪氨酸激酶抑制剂此次在中国获得附条件批准是基于Beamion-LUNG 1研究的积极结果该试验评估了宗艾替尼在HER2(ERBB2)突变晚期NSCLC患者中的疗效和安全性。

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