Mabwell (Shanghai) Bioscience Co., Ltd. announced that China’s National Medical Products Administration has approved a clinical trial application for 9MW5211 injection in inflammatory bowel disease (IBD). The investigational new drug application was accepted on 26 March 2026 and registered under approval No. 2026LP01718.
Simultaneously, the U.S. Food and Drug Administration has cleared the corresponding IBD study, while the NMPA has accepted additional filings covering multiple sclerosis (MS) and other autoimmune indications.
9MW5211 is a highly specific, depleting monoclonal antibody developed in-house to remove pathogenic immune cells that drive autoimmune disorders. Molecular-engineering optimisation has yielded strong target selectivity, deep cellular depletion and the potential for extended dosing intervals. Pre-clinical studies in murine autoimmune models and safety evaluations in cynomolgus monkeys support a favourable therapeutic and safety profile. According to the company, 9MW5211 is currently the first clinical-stage drug candidate worldwide against this target.
Market context: global IBD prevalence rose from 5.90 million patients in 2019 to 7.00 million in 2023 (CAGR 4.40%) and is forecast to reach 11.50 million by 2032 (CAGR 5.60%). MS incidence increased from 2.80 million in 2020 to 3.00 million in 2024, with projections of 3.50 million by 2035; in China, cases climbed from 32,800 to 33,900 over the same period and are expected to hit 35,500 by 2035.
Management cautions that drug development involves extended timelines and regulatory uncertainties; successful marketing of 9MW5211 is not guaranteed.
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