World's First | Mabwell's 9MW5211 Receives FDA Clearance for Clinical Trial Application

SHANGHAI, May 8, 2026 /PRNewswire/ -- Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the Investigational New Drug (IND) application for 9MW5211, its independently developed novel antibody, has received clearance from the U.S. Food and Drug Administration (FDA) to conduct clinical studies for the treatment of inflammatory bowel disease (IBD). Clinical trial applications for multiple indications including IBD and multiple sclerosis (MS) have been accepted for review by the National Medical Products Administration (NMPA) of China. 9MW5211 is the world's first clinical-stage drug candidate for its target.

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. Clinical trial applications for other 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.

About Mabwell

Mabwell (688062.SH, 02493.HK) is an innovation-driven biopharmaceutical company with capabilities spanning the entire pharmaceutical value chain. The company is committed to providing more effective and accessible therapies to meet global medical needs, with a focus on oncology and aging-related diseases. Mabwell's mission is "Explore Life, Benefit Health" and its vision is "Innovation, from Ideas to Reality." For more information, please visit www.mabwell.com/en.

Forward-Looking Statements

This press release contains forward-looking statements including, but not limited to, the potential safety, efficacy, regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development, clinical studies, clinical and regulatory milestones and timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties, which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms.

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