Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its self-developed CDH17-targeting ADC (R&D code: 7MW4911) received IND clearance from the U.S. Food and Drug Administration (FDA). The clearance enables the initiation of Phase I/II study of 7MW4911 to evaluate the safety, pharmacokinetics, and efficacy in patients with advanced colorectal cancer and other advanced gastrointestinal tumors.

7MW4911 is an investigational CDH17-targeting ADC developed using Mabwell's proprietary IDDC™ platform. Its highly optimized structure integrates three key elements:

• Mab0727: A highly specific CDH17 monoclonal antibody with rapid internalization properties, cross-species (human/monkey) moderate affinity, and minimal off-target binding.
• Novel cleavable linker: Ensures precise payload release in tumor tissues.
• 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.

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:

• 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.
• 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).
• MDR resistance: Outperforms MMAE/DXd-based ADCs in ABC transporter-mediated MDR models and reverses tumor progression post-ADC treatment.
• Target versatility: Active even in tumors with low-to-moderate CDH17 expression, expanding potential patient eligibility.
• Favorable safety profile: Limited tissue distribution in mice, controllable pharmacokinetics (moderate half-life, no accumulation), and a wide therapeutic window in cynomolgus monkeys, with no significant toxicity signals.

With this profile, 7MW4911 emerges as a promising therapeutic candidate for advanced gastrointestinal cancers. IND application of 7MW4911 has been accepted by China's National Medical Products Administration (NMPA).