Mabworks Biotech has received marketing approval in its China homeland for MIL62, a self-developed, innovative third-generation anti-CD20 moclonal antibody (mAb). The drug is approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare, relapsing autoimmune disease. MIL62 utilises a proprietary fucose knockout technology to enhance antibody-dependent cellular cytotoxicity (ADCC) and is the first domestic product of its class in China.

The approval is based on positive results from a Phase III trial, which demonstrated that MIL62 monotherapy significantly reduced the risk of disease relapse by 93.1% compared to a placebo. The therapy also met key secondary endpoints related to annualised relapse rates and MRI lesion activity. MIL62 exhibited a favourable safety and tolerability profile, with most treatment-related adverse events being low-grade. The approval addresses a significant unmet need in NMOSD, a high-disability disease included in China's first list of rare diseases.

PharmCube's NextBiopharm® database shows that MIL62 is being developed in a total of 13 indications. Click here to request a free trial for NextBiopharm®.