Mabwell (Shanghai) Bioscience Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has approved a clinical-trial application for its innovative antibody 9MW5211 Injection targeting multiple sclerosis (MS). The authorisation, issued under Approval Notice No. 2026LP01776, follows an application submitted on 3 April 2026.

9MW5211 is a highly specific, cell-depleting antibody designed to recognise pathogenic immune cells involved in autoimmune disorders. Molecular-engineering optimisation has delivered strong target selectivity and a favourable safety profile in cynomolgus monkey studies. Pre-clinical models show therapeutic potential across several autoimmune indications, positioning 9MW5211 as the first clinical-stage agent globally against this target.

In parallel, the NMPA and the U.S. Food and Drug Administration have cleared clinical-trial applications for 9MW5211 in inflammatory bowel disease (IBD). Additional indication filings are progressing, with several already accepted for review by the NMPA.

Market context underscores the programme’s commercial relevance. Global MS prevalence rose from 2.80 million cases in 2020 to 3.00 million in 2024 and is projected to reach 3.50 million by 2035. In China, patient numbers increased from 32,800 in 2020 to 33,900 in 2024 and are expected to climb to 35,500 by 2035. Separately, newly diagnosed IBD cases worldwide grew from 5.90 million in 2019 to 7.00 million in 2023, a 4.40 % compound annual growth rate (CAGR); incidence is forecast to hit 11.50 million by 2032, implying a 5.60 % CAGR from 2023 to 2032.

Mabwell highlights that drug development entails lengthy, multi-stage regulatory processes with inherent uncertainties. The company intends to advance 9MW5211 through clinical development while complying with ongoing disclosure requirements under Hong Kong listing rules.