Mabwell Announces IND Application Acceptance for CDH17-Targeting ADC 7MW4911 from Both NMPA and FDA

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[{"type":"text","content":"SHANGHAI, Aug. 1, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its proprietary CDH17-targeting antibody-drug conjugate (ADC), 7MW4911, has received Investigational New Drug (IND) application acceptance from China's National Medical Products Administration (NMPA) and an IND Acknowledgement Letter from the U.S. Food and Drug Administration (FDA).","length":435,"tagName":"p"},{"type":"text","content":"7MW4911 is an investigational CDH17-targeting ADC developed using Mabwell's proprietary IDDC™ platform. Its highly optimized structure integrates three key elements:","length":169,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Mab0727: A highly specific CDH17 monoclonal antibody with rapid internalization properties, cross-species (human/monkey) moderate affinity, and minimal off-target binding.","length":176,"tagName":"p"}]},{"val":[{"type":"text","content":"Novel cleavable linker: Ensures precise payload release in tumor tissues.","length":78,"tagName":"p"}]},{"val":[{"type":"text","content":"MF-6 payload: A proprietary DNA topoisomerase I inhibitor designed to overcome multidrug resistance (MDR), exhibiting superior plasma stability, controlled drug release, and potent bystander effects.","length":204,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":458,"olType":false},{"type":"text","content":"In July 2025, Mabwell published preclinical data in Cell Reports Medicine ("Overcoming multidrug resistance in gastrointestinal cancers with a CDH17-targeted ADC conjugated to a DNA topoisomerase inhibitor"), demonstrating 7MW4911's tumor-selective cytotoxicity via CDH17-mediated internalization. Key advantages include:","length":340,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Optimized molecular design: Homogeneous drug-to-antibody ratio (DAR=4, >95%) and stable linker confer exceptional plasma stability, while membrane-permeable MF-6 drives potent bystander killing.","length":197,"tagName":"p"}]},{"val":[{"type":"text","content":"Broad Antitumor Efficacy: Demonstrates robust tumor regression in colorectal, gastric, and pancreatic cancer PDX/CDX models, including tumors with RAS/BRAF mutations and diverse Consensus Molecular Subtypes (CMS)."...

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