映恩生物（股票代码：09606）宣布，其针对不可切除或转移性HER2阳性成人乳腺癌的创新抗体偶联药物（ADC）Trastuzumab Pamirtecan，已正式向中国国家药品监督管理局（NMPA）提交生物制品许可申请（BLA），并获受理。
此次BLA获受理是基于一项关键性临床研究数据的积极结果。该研究旨在评估Trastuzumab Pamirtecan在经治的HER2阳性晚期乳腺癌患者中的疗效与安全性。数据显示，该候选药物在主要疗效终点上表现出显著优势，有望为现有治疗选择有限的患者提供新的治疗希望。
若后续审评进展顺利并获得批准，Trastuzumab Pamirtecan将成为映恩生物在肿瘤治疗领域商业化进程中的重要里程碑，为国内HER2阳性乳腺癌患者带来新的治疗选择。
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