智通财经APP讯，映恩生物-B(09606)发布公告，经独立数据监察委员会(IDMC)评估，与对照组相比，DB-1303/BNT323用于既往接受曲妥珠单抗和紫杉烷类治疗的HER2阳性不可切除或转移性乳腺癌患者的III期临床试验(该试验)已达到由盲态独立中心审阅 (BICR)评估的无进展生存期(PFS)主要研究终点。
根据这项中期分析结果，本公司计划与中国国家药品监督管理局(国家药监局)药品审评中心(药审中心)就提交DB-1303/BNT323生物制品上市许可申请(BLA)进行沟通。
该试验是一项在中国进行的随机、对照、开放标签、多中心的III期临床试验，旨在评估DB-1303相较于T-DM1在既往接受曲妥珠单抗和紫杉烷类治疗的HER2阳性不可切除或转移性乳腺癌患者中的疗效和安全性。
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