Chinese biopharmaceutical innovator Mabwell has announced a major milestone in its oncology pipeline: 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 acknowledgment letter from the U.S. Food and Drug Administration (FDA).
The dual regulatory approvals pave the way for clinical trials to begin in both China and the U.S., accelerating development of this potential breakthrough therapy for advanced gastrointestinal cancers.
What is 7MW4911?
Developed using Mabwell’s proprietary IDDC (Intelligent Design Drug Conjugate) platform, 7MW4911 is a CDH17-focused ADC with three key components:
Mab0727, a monoclonal antibody with fast internalization, low off-target binding, and moderate human/monkey cross-species affinity
A cleavable linker engineered for precise payload release at tumor sites
MF-6, a novel DNA topoisomerase I inhibitor designed to minimize multidrug resistance (MDR), induce bystander killing, and ensure high plasma stability
Together, these components deliver a highly targeted cytotoxic payload directly to tumor cells expressing CDH17, while sparing healthy tissue.
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Robust Preclinical Data Supports IND Approval
Mabwell’s preclinical findings, published in Cell Reports Medicine in July 2025, demonstrated that 7MW4911 exhibits tumor-selective cytotoxicity via CDH17-mediated internalization. The study showed promising results across a range of gastrointestinal cancer models, including gastric, pancreatic, and colorectal cancers with varying RAS/BRAF mutations and molecular subtypes.
Key highlights of 7MW4911’s performance:
Overcomes MDR: Outperforms MMAE/DXd-based ADCs in models with ABC transporter-mediated drug resistance
Broad Antitumor Efficacy: Triggers tumor regression even in low to moderate CDH17-expressing tumors
High Stability & Precision: Features a drug-to-antibody ratio (DAR) of 4 and >95% homogeneity
Safety Profile: Demonstrates limited off-target toxicity, no drug accumulation, and a favorable pharmacokinetic profile in preclinical monkey and mouse studies
A Strategic Leap Toward Cancer Innovation
The regulatory green lights from both the NMPA and FDA mark an important step forward for Mabwell’s commitment to fighting severe cancers through precision biologics and next-gen ADCs. The company now looks forward to launching exploratory clinical trials that will further determine the efficacy and safety of 7MW4911 in human subjects.
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