智通财经APP讯，荣昌生物(09995)公布，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生存期(PFS)，疾病进展或死亡风险降低了44%(中位PFS:9.9个月vs 4.9个月;风险比(HR)=0.56，P=0.0143)。总生存期(OS)数据尚未成熟，但维迪西妥单抗组已显示出更强的获益趋势，中位 OS分别为不可评估(Not Evaluable) vs 25.9个月(HR=0.56, 95% CI:0.25-1.29)。维迪西妥单抗组整体安全性良好，未发现新的安全性信号。
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