en.Wedoany.com Reported - Shanghai, June 4, 2026 — Mabwell (688062.SH, 02493.HK) 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 world's first candidate drug targeting this specific mechanism to enter the clinical stage.
9MW5211 is a highly specific, depleting innovative antibody independently developed by Mabwell, designed to precisely intervene in the key pathological mechanisms mediated by abnormal immune cells in autoimmune diseases. The target molecule of this drug is specifically expressed on the surface of pathogenic immune cells and serves as an important biomarker for their abnormal activation. By selectively recognizing and depleting these pathogenic cells, 9MW5211 can effectively block the immune cascade, thereby delaying disease progression and improving clinical symptoms.
Through multiple rounds of molecular engineering optimization, 9MW5211 demonstrates excellent target selectivity, achieving efficient blockade while significantly reducing the risk of non-specific binding, ensuring deep depletion of pathogenic cells with high target protein expression. This unique mechanism of action is expected not only to enable deeper disease remission but also to support extended dosing intervals, thereby improving patient compliance and quality of life.
Preclinical study results indicate that 9MW5211 exhibits significant therapeutic potential in various mouse models of autoimmune diseases, suggesting its future clinical application may cover multiple major indications. Safety assessments conducted in cynomolgus monkey models show a favorable safety profile.
Previously, 9MW5211 had received approval from the U.S. Food and Drug Administration (FDA) to conduct clinical trials for IBD in the United States. Clinical trial applications for multiple indications, including Multiple Sclerosis (MS), have been accepted by the NMPA, and applications for additional indications are being actively advanced.
Inflammatory Bowel Disease is a chronic, relapsing immune-mediated gastrointestinal disorder, primarily including Ulcerative Colitis and Crohn's Disease. The number of global IBD cases continues to rise. Epidemiological studies show that the number of newly diagnosed IBD patients worldwide increased from 5.9 million in 2019 to 7.0 million in 2023, with a Compound Annual Growth Rate (CAGR) of 4.4%. It is projected that by 2032, the number of newly diagnosed IBD patients globally will reach 11.5 million, with a CAGR of 5.6% from 2023 to 2032.
Multiple Sclerosis is a chronic autoimmune disease characterized by inflammatory damage to the protective myelin sheath surrounding nerves in the brain and spinal cord. The number of MS patients globally increased from 2.8 million in 2020 to 3.0 million in 2024, and is expected to reach approximately 3.5 million by 2035. In China, the number of MS patients increased from 32,800 cases in 2020 to 33,900 cases in 2024, and is projected to reach 35,500 cases by 2035.
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