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注射用重组抗Ep CAM和CD3人鼠嵌合双特异性抗体M701
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友芝友生物-B:M 701取得FDA的IND批准
Zhi Tong Cai Jing· 2026-02-03 10:18
Core Viewpoint - The approval of the clinical trial application for M701 by the FDA marks a significant advancement in the international clinical development of an innovative therapy targeting malignant pleural effusion (MPE), providing new hope for patients globally [1] Group 1: Product Development - The product M701 is a recombinant bispecific antibody targeting epithelial cell adhesion molecule (Ep CAM) and cluster of differentiation 3 (CD3), specifically designed for treating MPE [1] - M701 targets Ep CAM, which is highly expressed in tumor cells associated with epithelial-derived malignant pleural effusion, making it a critical therapeutic target [1] - The clinical trial is an open-label, multicenter, Phase Ib/II study aimed at evaluating the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of M701 in patients with malignant pleural effusion caused by advanced epithelial tumors [1] Group 2: Clinical Need - Malignant pleural effusion is a common and severe complication of malignant tumors, particularly in patients with advanced lung and breast cancers, highlighting the urgent need for innovative treatment strategies to fill the clinical gap [1] - Current treatment approaches primarily focus on palliative care, indicating a significant opportunity for new therapeutic options in this area [1]