Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that its independently developed innovative antibody drug 9MW5211 has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for inflammatory bowel disease (IBD). 9MW5211 is the first candidate drug for its target to enter clinical stage globally.

9MW5211 is a highly specific, depleting, and innovative antibody independently developed by Mabwell, designed to precisely intervene in the key pathological mechanisms mediated by abnormal immune cells in autoimmune diseases. The abnormal activation and tissue infiltration of immune cells act as the core driving factors in the occurrence and development of various autoimmune diseases. The target molecule of 9MW5211 is specifically expressed on the surface of pathogenic immune cells and serves as a vital biological marker of their abnormal activation. By selectively recognizing and depleting this population of pathogenic cells, 9MW5211 can effectively block the immune cascade, thereby delaying disease progression and ameliorating clinical symptoms.

Through multiple rounds of molecular engineering optimization, 9MW5211 has demonstrated excellent target selectivity. While achieving efficient blockade, it significantly mitigates the risk of non-specific binding, ensuring deep depletion of pathogenic cells highly expressing the target protein. Such a unique mechanism of action is expected to not only bring deeper disease remission but also potentially support an extended dosing interval, thereby enhancing patient compliance and quality of life.

Preclinical study results have demonstrated that 9MW5211 exhibits significant therapeutic potential in various mouse models of autoimmune diseases, suggesting its future clinical application may cover multiple major indications. Safety evaluations conducted in cynomolgus monkey models have shown a favorable safety profile.

Previously, 9MW5211 has received clearance from FDA to conduct clinical trials for IBD in the US. Its clinical trial applications for multiple indications, including multiple sclerosis (MS), have been accepted by the NMPA. Clinical trial applications for more indications are also being actively advanced.

About Inflammatory Bowel Disease (IBD)

Inflammatory bowel disease is a chronic, relapsing, immune-mediated disorder of the gastrointestinal tract, which primarily includes ulcerative colitis and Crohn’s disease. The number of IBD cases globally has been steadily increasing. Epidemiological studies indicate that the number of newly diagnosed IBD patients worldwide rose from 5.90 million in 2019 to 7.00 million in 2023, representing a compound annual growth rate (CAGR) of 4.4%. The number of newly diagnosed IBD patients globally is projected to reach 11.50 million by 2032, with a CAGR of 5.6% from 2023 to 2032

About Multiple Sclerosis (MS)

Multiple sclerosis is a chronic autoimmune disease characterized by inflammatory damage to the protective myelin sheaths surrounding the nerves of the brain and spinal cord. The number of MS patients globally increased from 2.80 million cases in 2020 to 3.00 million cases in 2024, and is projected to reach approximately 3.50 million cases by 2035. In China, the number of MS patients increased from 32,800 cases in 2020 to 33,900 cases in 2024, and is expected to reach 35,500 cases by 2035.