翰森製藥(03692)：阿美樂® (甲磺酸阿美替尼片)第五項上市許可申請獲國家藥品監督管理局受理

智通財經

2024/11/27

智通財經APP訊，翰森製藥(03692)發布公告，集團創新藥阿美樂® (甲磺酸阿美替尼片)的第五項上市許可申請(NDA)獲中國國家藥品監督管理局(NMPA)受理，適應症為阿美樂®聯合培美曲塞和鉑類化療藥物適用於具有表皮生長因子受體(EGFR)外顯子19缺失或外顯子21(L858R)置換突變的局部晚期或轉移性非小細胞肺癌(NSCLC)成人患者的一線治療。

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