翰森制药创新药阿美乐?获药品注册证书
3月10日，翰森制药（03692）发布公告，宣布其创新药阿美乐®（甲磺酸阿美替尼片）获得中国国家药品监督管理局（NMPA）签发的药品注册证书，批准增加新的适应症。
这一新适应症是针对经过铂类根治性放化疗后未出现疾病进展的不可切除的局部晚期非小细胞肺癌（NSCLC）患者。这是阿美乐®获批的第三项适应症。
阿美乐®是中国首个原研第三代EGFR-TKI创新药，之前已获得两项适应症的批准，分别是2020年3月用于EGFR-TKI治疗进展且T790M突变阳性的局部晚期或转移性NSCLC患者，以及2021年12月用于EGFR外显子19缺失或外显子21(L858R)置换突变阳性的局部晚期或转移性NSCLC成人患者的一线治疗。以上两项适应症已于2024年11月续约纳入2024版国家医保目录。此外，阿美乐®还有两项上市许可申请已获NMPA受理，进一步扩展其适应症范围。
（文章来源：财中社）
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