Mabwell(SH:688062) Zheng Quan Zhi Xing·2025-07-31 16:15Core Viewpoint - The company, Maiwei (Shanghai) Biotechnology Co., Ltd., has received acceptance notifications for its clinical trial application for the injectable drug 7MW4911 from both the National Medical Products Administration (NMPA) and the U.S. FDA, indicating progress in its drug development efforts [1][2][3] Drug Basic Information - The drug name is injectable 7MW4911, and the application is for domestic production drug registration clinical trials with acceptance number CXSL2500640 by NMPA [1] - The U.S. FDA has accepted the new drug clinical trial application for 7MW4911 with acceptance number IND 176738 [2] Drug Characteristics - 7MW4911 is an innovative antibody-drug conjugate (ADC) targeting Cadherin 17 (CDH17), which is overexpressed in gastrointestinal malignancies such as colorectal, gastric, and pancreatic cancers, making it a promising therapeutic target [2][3] - The drug features a high specificity monoclonal antibody Mab0727, a novel cleavable linker, and a proprietary DNA topoisomerase I inhibitor MF-6, designed to overcome multidrug resistance [2][3] - The drug demonstrates significant antitumor activity in preclinical models of colorectal, gastric, and pancreatic cancers, showing deep tumor suppression effects and effectiveness against various mutations [3] Safety and Efficacy - Preclinical studies indicate that 7MW4911 has a favorable safety profile, with limited tissue distribution and controllable metabolic characteristics, showing no significant toxicity signals [3] - The drug's design allows for high plasma stability and effective drug release, enhancing its antitumor efficacy [3] Future Prospects - Based on its characteristics and preclinical results, 7MW4911 has the potential to become a transformative therapy for advanced gastrointestinal solid tumors, with its clinical trial applications now officially accepted by regulatory authorities [3]