智通财经APP讯，翰森制药(03692)发布公告，集团创新药阿美乐® (甲磺酸阿美替尼片)获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“用于含铂根治性放化疗后未出现疾病进展的不可切除的局部晚期表皮生长因子受体(EGFR)外显子19 缺失或外显子21(L858R)置换突变的非小细胞肺癌(NSCLC)患者的治疗”适应症。此为阿美乐®获批的第三项适应症。
阿美乐® (甲磺酸阿美替尼片)是中国首个原研三代EGFR-TKI创新药，此前已于中国获批两项适应症，分别为：2020年3月，获批用于既往经EGFR-TKI治疗进展，且T790M突变阳性的局部晚期或转移性NSCLC患者;2021年12月，获批用于具有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。该两项适应症均已于2024年11月续约纳入2024版国家医保目录。
阿美乐®另有两项上市许可申请(NDA)已获NMPA受理，分别为：用于具有EGFR 外显子19缺失或外显子21(L858R)置换突变阳性的NSCLC成人患者肿瘤切除术后的辅助治疗;联合培美曲塞和铂类化疗药物适用于具有EGFR外显子19缺失或外显子21(L858R)置换突变的局部晚期或转移性NSCLC成人患者的一线治疗。
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