Mabwell secures NMPA clearance to begin clinical trials of 9MW5211 for vitiligo

Bulletin Express07-15 20:41

On 15 July 2026, Mabwell (Shanghai) Bioscience Co., Ltd. disclosed that China’s National Medical Products Administration (NMPA) has approved the company’s clinical-trial application for 9MW5211 Injection in vitiligo. The approval is documented under Clinical Trial Approval Notice No. 2026LP021512; the submission was accepted on 11 May 2026 and classified as a registration trial for a domestically-produced drug.

9MW5211 is an innovative, highly specific depleting antibody designed to eliminate pathogenic immune cells that drive autoimmune disease. Molecular-engineering optimisation has produced strong target selectivity while limiting off-target binding, with pre-clinical studies indicating deep depletion of disease-related cells and a favourable safety profile in cynomolgus monkeys.

With the latest authorisation, 9MW5211 now holds the following regulatory statuses: • China: clinical-trial approvals for vitiligo, type 1 diabetes mellitus (T1DM), multiple sclerosis (MS) and inflammatory bowel disease (IBD). • United States: FDA clearance to start clinical trials in IBD. Additional indications are under active review by the NMPA.

Market context underscores the drug’s potential reach: • Vitiligo affects 0.50%–2.00% of the global population and 0.56% in China. • T1DM impacts 9.15 million people worldwide, including 599,000 cases in China. • MS cases increased from 2.80 million in 2020 to 3.00 million in 2024 globally and are projected to reach 3.50 million by 2035; China had 33,900 cases in 2024, expected to rise to 35,500 by 2035. • Newly diagnosed IBD patients worldwide grew from 5.90 million in 2019 to 7.00 million in 2023 (CAGR 4.4%) and are forecast to hit 11.50 million by 2032 (CAGR 5.6%).

The company reiterates that drug development entails lengthy timelines and multiple regulatory stages, and there is no assurance that 9MW5211 will ultimately reach market. Mabwell will continue to report material progress in accordance with exchange disclosure rules, reminding investors to remain prudent given inherent sector risks.

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