13 October 2025: Mabwell’s CDH17-targeting ADC 7MW4911 Receives IND Clearance from NMPA
Mabwell’s CDH17-targeting ADC, 7MW4911, received IND clearance from China’s NMPA to begin clinical trials in patients with advanced solid tumors
Developed using the IDDC platform, 7MW4911 combines a CDH17 antibody (Mab0727), a novel cleavable linker, and MF-6, a proprietary DNA topoisomerase I inhibitor designed to overcome multidrug resistance (MDR)
Preclinical studies (Cell Reports Medicine, July 2025) showed strong tumor regression in colorectal, gastric, and pancreatic cancer models, including those with RAS/BRAF mutations, and activity across molecular subtypes
The ADC demonstrated superior efficacy over MMAE/DXd ADCs in MDR models, potent bystander killing, activity in low CDH17 tumors, and a favorable safety and pharmacokinetic profile in animal studies
7MW4911 has also received FDA IND clearance to initiate U.S. clinical trials for advanced colorectal and gastrointestinal cancers, underscoring its global development potential