同源康(02410.HK)1类新药氘申艾替尼片获批附条件上市,为EGFR突变肺癌脑转移临床治疗带来新选择

智通财经
Aug 28
【同源康(02410.HK)1类新药氘申艾替尼片获批附条件上市,为EGFR突变肺癌脑转移临床治疗带来新选择】智通财经APP获悉,2026年8月27日,港股创新药企同源康医药(02410.HK)宣布,公司自主研发的1类新药甲磺酸氘申艾替尼片(TY-9591)已获得中国国家药品监督管理局(NMPA)批准附条件上市,用于具有表皮生长因子受体(EGFR)外显子19缺失(19DEL)或外显子21(L858R)置换突变,并伴有中枢神经系统(CNS)转移的局部晚期或转移性非小细胞肺癌(NSCLC)成人患者的一线治疗。该产品的获批,为临床上治疗难度较大的EGFR突变非小细胞肺癌脑转移患者带来了全新的国产靶向治疗方案,也标志着国产新一代EGFR‑TKI实现了重要临床突破。

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