智通财经APP讯，友芝友生物-B(02496)发布公告，于2026年1月31日，注射用重组抗上皮细胞黏附分子(Ep CAM)和分化簇3(CD3)人鼠嵌合双特异性抗体(M 701)获美国食品药物管理局(FDA)临床试验申请(IND)批准，标志着这款针对恶性胸腔积液(MPE)的创新疗法迈入国际化临床开发新阶段，为全球患者带来新希望。
恶性胸腔积液是恶性肿瘤常见且严重并发症，多见于晚期肺癌、乳腺癌患者，目前治疗仍以“姑息为主”，临床亟需创新策略填补临床空白。M 701精准靶向Ep CAM和CD3，其中Ep CAM在上皮来源恶性胸腔积液肿瘤细胞中高频表达，是关键治疗靶点;CD3可激活机体抗肿瘤免疫，二者协同实现精准治疗。
本次获批的临床试验是一项开放标签、多中心、Ib/II期临床研究，旨在评估注射用重组抗Ep CAM和CD3人鼠嵌合双特异性抗体M 701经胸腔内输注治疗晚期上皮性肿瘤所致恶性胸腔积液患者的安全性、有效性、药代动力学、药效学及免疫原性。
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