百利天恒:EGFR×HER3双抗ADC药品上市申请获受理

财中社
Jun 14

6月14日,百利天恒(688506)发布公告,近日公司收到国家药品监督管理局药品审评中心核准签发的《受理通知书》,公司自主研发的全球首创EGFR×HER3双抗ADC(iza-bren)的药品上市申请已获得正式受理。该药品适用于既往经紫杉烷类治疗失败的不可手术切除的局部晚期或转移性三阴乳腺癌。  此次上市申请的受理基于iza-bren在三阴乳腺癌的III期临床试验中达到的无进展生存期和总生存期双主要...

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