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 abnormal activation and tissue infiltration of immune cells are core driving factors in the onset and progression of various autoimmune diseases. The molecule targeted by 9MW5211 is specifically expressed on the surface of pathogenic immune cells and serves as an important biological marker of their abnormal activation. By selectively recognizing and depleting these pathogenic cells, 9MW5211 can effectively block the immune cascade, thereby alleviating 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. Its unique mechanism of action not only holds promise for deeper disease remission but may also support longer dosing intervals, thereby enhancing patient treatment compliance and quality of life.
Preclinical study results show that 9MW5211 exhibits significant therapeutic potential in various mouse models of autoimmune diseases, with future clinical applications expected to cover multiple major indications. Safety assessments conducted in cynomolgus monkey models indicate a favorable safety profile.
Previously, 9MW5211 has received FDA clearance to conduct clinical trials in the United States for IBD. Its clinical trial applications for multiple indications, including multiple sclerosis (MS), have been accepted by the NMPA, and applications for additional indications are being advanced.
About Inflammatory Bowel Disease (IBD)
IBD is a chronic, relapsing, immune-mediated gastrointestinal disease, primarily including ulcerative colitis and Crohn’s disease. The number of global IBD cases is steadily increasing. Epidemiological studies show that the number of new IBD patients worldwide rose from 5.9 million in 2019 to 7.0 million in 2023, with a compound annual growth rate of 4.4%. It is projected that the number of new IBD patients globally will reach 11.5 million by 2032, with a compound annual growth rate of 5.6% from 2023 to 2032.
About Multiple Sclerosis (MS)
MS is a chronic autoimmune disease in which inflammatory responses damage the protective myelin sheath surrounding nerves in the brain and spinal cord. The global number of MS patients increased from 2.8 million in 2020 to 3.0 million in 2024, and is expected to reach approximately 3.5 million by 2035. The number of MS patients in China grew from 32,800 in 2020 to 33,900 in 2024, and is projected to reach 35,500 by 2035.
About Mabwell
Mabwell (688062.SH, 02493.HK) is an innovative biopharmaceutical company with a full industry chain layout. Adhering to the vision of “Turning Innovation into Reality” and the mission of “Exploring Life, Benefiting Health,” the company is committed to providing patients with better and more accessible innovative biologics through original innovation to address unmet global clinical needs. Since its establishment in 2017, Mabwell has built an innovation system covering the entire drug R&D cycle, starting from antibody drug target discovery and molecular discovery, through druggability research, preclinical research, clinical research, and production transformation, achieving a full industry chain layout integrating R&D, production, and marketing. We focus on oncology and age-related diseases, covering therapeutic areas such as oncology, autoimmune diseases, bone diseases, ophthalmology, hematology, and cardiovascular diseases. Leveraging multi-field specialized technology platforms and R&D innovation capabilities, we have established a rich and competitive pipeline. Currently, we have 16 key products at different stages, including 4 products on the market, 1 product under regulatory review, and 2 products in Phase III pivotal registration clinical trials. We have independently undertaken 1 national “Major New Drug Creation” major science and technology project, 2 national key R&D programs, and multiple provincial and municipal science and technology innovation projects. Mabwell is innovation-oriented and emphasizes industrial transformation. Its antibody and recombinant protein drug industrialization base, compliant with China NMPA, US FDA, and EU EMA GMP standards, has been put into operation in Taizhou, Jiangsu Province, and has passed the EU QP audit. Large-scale commercial production bases in Jinshan, Shanghai, and Taizhou, Jiangsu, are under construction. For more information, please visit: www.mabwell.com.
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