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Mabwell's 9MW5211 Receives IND Clearance from NMPA for Inflammatory Bowel Disease
The antibody is the first for its target to reach clinical testing worldwide and already has U.S. clearance, the company said.
- On Thursday, Mabwell received National Medical Products Administration approval to conduct clinical trials for its antibody drug 9MW5211, targeting inflammatory bowel disease in China.
- Previously, the company received FDA clearance to conduct IBD trials in the United States for 9MW5211, a highly specific, depleting antibody designed to intervene in pathological mechanisms in autoimmune diseases.
- Epidemiological studies indicate rising IBD burden, with newly diagnosed patients worldwide increasing from 5.90 million in 2019 to 7.00 million in 2023, representing a compound annual growth rate of 4.4%.
- Mabwell has also seen its clinical trial applications for multiple indications, including Multiple Sclerosis , accepted by the NMPA, addressing a global patient population projected to reach 3.50 million by 2035.
- The drug demonstrated a favorable safety profile in preclinical evaluations, positioning the company to advance its fully integrated pharmaceutical development capabilities across multiple autoimmune disease indications.
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The Courier-Tribune+57 Reposted by 57 other sources
Mabwell's 9MW5211 Receives IND Clearance from NMPA for Inflammatory Bowel Disease
SHANGHAI, June 4, 2026 /PRNewswire/ -- 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…
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Leaning Left9Leaning Right7Center21Last UpdatedBias Distribution57% Center
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