Chinese biopharmaceutical company Mabwell has secured approval from the country’s regulator, the National Medical Products Administration (NMPA), to begin clinical trials of its independently developed antibody drug candidate, 9MW5211, for the treatment of inflammatory bowel disease (IBD).
The investigational therapy had previously received clearance from the US Food and Drug Administration (FDA) to enter clinical trials for IBD in the United States.
According to Mabwell, 9MW5211 is the first drug candidate for its target to advance into clinical development. The company describes it as a highly specific, depleting antibody designed to precisely intervene in the key pathological mechanisms mediated by abnormal immune cells in autoimmune diseases.
Inflammatory bowel disease is a chronic, relapsing, immune-mediated disorder affecting the gastrointestinal tract, which mainly includes ulcerative colitis and Crohn’s disease.
Mabwell said the abnormal activation and infiltration of immune cells are key drivers behind the development and progression of autoimmune diseases. The target molecule of 9MW5211 is specifically expressed on the surface of pathogenic immune cells and acts as an important biomarker 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,” it explained.
The company added that multiple rounds of molecular engineering optimisation have enabled the drug candidate to demonstrate strong target selectivity and efficient blockade, while minimising the risk of non-specific binding. This approach ensures deep depletion of pathogenic cells with high target protein expression.
Mabwell believes the therapy’s unique mechanism of action could lead to deeper disease remission and potentially support longer dosing intervals, thereby enhancing patient compliance and quality of life.
Preclinical studies showed promising therapeutic effects across several mouse models of autoimmune diseases. In addition, safety evaluations conducted in cynomolgus monkeys demonstrated a favourable safety profile.
The NMPA has also accepted clinical trial applications for 9MW5211 in multiple sclerosis (MS), a chronic autoimmune disease that damages the protective myelin sheath surrounding nerves in the brain and spinal cord.
Mabwell said it is actively advancing clinical trial applications for additional indications as well.
