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翰森製藥(03692.HK):阿美樂®(甲磺酸阿美替尼片)第四項適應症獲國家藥品監督管理局簽發藥品註冊證書
格隆匯 05-09 17:53

格隆匯5月9日丨翰森製藥(03692.HK)發佈公吿,集團創新藥阿美樂®(甲磺酸阿美替尼片)獲中國國家藥品監督管理局(NMPA)簽發的藥品註冊證書,批准增加「用於II-IIIB期具有表皮生長因子受體(EGFR)外顯子19缺失或外顯子21(L858R)置換突變的成人非小細胞肺癌「NSCLC」)患者的治療,患者須既往接受過手術切除治療,並由醫生決定接受或不接受輔助化療」適應症。此為阿美樂®獲批的第四項適應症。

阿美樂®另有一項上市許可申請(NDA)已獲NMPA受理,其為:聯合培美曲塞和鉑類化療藥物適用於具有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NSCLC成人患者的一線治療。

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