荣昌生物:国家药品监督管理局批准注射用维迪西妥单抗用于治疗HER2阳性且存在肝转移的晚期乳腺癌在中国上市

格隆汇
09 May

格隆汇5月9日丨荣昌生物(09995.HK)公告,注射用维迪西妥单抗(商品名:爱地希)正式获得中国国家药品监督管理局(NMPA)在中国上市的批准,用于治疗HER2阳性且存在肝转移的晚期乳腺癌的患者。本适应症获得批准是基于RC48-C006 III期临床研究,详细数据在2024年12月的圣安东尼奥乳腺癌研讨会(SABCS)公布,结果显示:相比拉帕替尼联合卡培他滨组,维迪西妥单抗组显著延长了无进展...

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