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World's First | Mabwell's 9MW5211 Receives FDA Clearance for Clinical Trial Application
The clearance allows Mabwell to begin clinical studies of its antibody candidate for inflammatory bowel disease after favorable preclinical safety and efficacy results.
- On Friday, May 8, 2026, Mabwell announced the U.S. Food and Drug Administration cleared its Investigational New Drug application for 9MW5211 to conduct clinical studies for inflammatory bowel disease .
- As the world's first clinical-stage drug candidate for its target, 9MW5211 selectively depletes pathogenic cells to block immune cascades and address key mechanisms driving autoimmune disease.
- Epidemiological studies indicate newly diagnosed IBD patients worldwide rose from 5.90 million in 2019 to 7.00 million in 2023, representing a compound annual growth rate of 4.4%.
- Beyond the U.S. clearance, the Company has submitted clinical trial applications for multiple indications, including IBD and multiple sclerosis , currently under review by the National Medical Products Administration of China.
- Preclinical safety evaluations in cynomolgus monkey models showed a favorable profile, supporting the Company's mission to "Explore Life, Benefit Health" and its vision "Innovation, from Ideas to Reality.
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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.…
·Cherokee County, United States
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