翰森制药(03692.HK):阿美乐一线治疗EGFR突变阳性局部晚期或转移性非小细胞肺癌上市许可申请获国家药监局受理
格隆汇5月13日丨翰森制药(03692.HK)公告,由公司附属公司江苏豪森药业集团有限公司开发的1类创新药阿美乐一线治疗具有EGFR敏感突变的阳性局部晚期或转移性非小细胞肺癌(NSCLC)上市许可申请,获中国国家药品监督管理局(NPMA)受理。此次申请为阿美乐第二个适应症。
阿美乐是一种新型的,不可逆的表皮生长因子受体酪氨酸激酶抑制剂(EGFRTKI),具有良好的药学特性可以选择性的抑制EGFR敏感和耐受突变。阿美乐(甲磺酸阿美替尼片,HS-10296),每日治疗剂量为110毫克的片剂,已经被NMPA批准作为用于既往经EGFRTKI治疗时或治疗后出现疾病进展的,存在EGFRT790M突变阳性的局部晚期或转移性NSCLC患者的药品。
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