Core Viewpoint - The approval of the clinical trial application for M701 by the FDA marks a significant advancement in the international clinical development of a novel therapy targeting malignant pleural effusion (MPE), offering new hope for patients globally [1] Group 1: Company Developments - Youzhiyou Biotech-B (02496) announced the FDA's approval for the clinical trial of M701, a recombinant bispecific antibody targeting EpCAM and CD3, set to begin on January 31, 2026 [1] - M701 is designed to address MPE, a common and severe complication in malignant tumors, particularly in late-stage lung and breast cancer patients, where current treatments primarily focus on palliative care [1] Group 2: Product Details - M701 specifically targets EpCAM, which is frequently expressed in epithelial-derived malignant pleural effusion tumor cells, and CD3, which activates the body's anti-tumor immunity, enabling precise treatment through their synergistic action [1] - The approved 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]
友芝友生物-B(02496)：M701取得FDA的IND批准