Core Viewpoint - The approval of M 701 by the FDA marks a significant advancement in the clinical development of a novel therapy for malignant pleural effusion (MPE), providing new hope for patients globally [1] Company Summary - Youzhiyou Biotechnology-B (02496) announced that its recombinant anti-epithelial cell adhesion molecule (Ep CAM) and cluster of differentiation 3 (CD3) human-mouse chimeric bispecific antibody M 701 received IND approval from the FDA on January 31, 2026 [1] - M 701 targets Ep CAM and CD3, with Ep CAM being highly expressed in epithelial-derived malignant pleural effusion tumor cells, making it a key therapeutic target [1] Industry Summary - Malignant pleural effusion is a common and severe complication of malignant tumors, particularly in advanced lung and breast cancer patients, with current treatments primarily focused on palliative care [1] - There is an urgent need for innovative strategies to fill the clinical gap in treating MPE, which M 701 aims to address through its precise targeting and immune activation [1] - The approved clinical trial is an open-label, multi-center, Phase Ib/II study designed to evaluate the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of M 701 in patients with malignant pleural effusion caused by advanced epithelial tumors [1]
友芝友生物-B(02496)：M 701取得FDA的IND批准