Mabwell’s Novel ADC 9MW2921 Accepted for NMPA Review

China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that a clinical trial filing for its novel antibody-drug conjugate (ADC) 9MW2921 has been accepted for review by the National Medical Products Administration (NMPA). The firm is seeking to assess the ADC as a treatment for general solid tumors, marking a significant step in the development of innovative cancer therapies.

9MW2921: Next-Generation ADC
9MW2921 is a next-generation ADC based on Mabwell’s innovative ADC technology platform IDDC. The molecule features stable structure, uniform composition, high purity, and ease of industrialization and amplification. Compared to similar products, 9MW2921 demonstrates significant improvements in endocytosis activity, plasma stability, drug release characteristics, bystander-killing effect, and more. In safety evaluation testing in cynomolgus monkeys, rats, and other animals, 9MW2921 has effectively controlled target-related and off-target toxicity, indicating good drug safety and pharmacokinetic characteristics.

IDDC Platform and Future Pipeline
Mabwell’s IDDC platform enables ADCs with better structural homogeneity, quality stability, efficacy, and tolerability. The company aims to advance another three to five ADC products into clinical trials during 2023-2024, further solidifying its position in the development of advanced cancer treatments.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry