Hansoh Pharma Announces Positive Global Phase III MITIGATE Trial Results of Inebilizumab for IgG4-Related Disease

On November 19, Hansoh Pharmaceutical Group Company Limited (hereinafter referred to as "Hansoh Pharma") announced that the positive results data from the global Phase III clinical MITIGATE study of the innovative biologic drug Inebilizumab (Chinese trade name: Xinyue) for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD) were presented at the American College of Rheumatology (ACR) Annual Meeting held in Washington, D.C., USA, from November 14 to 19.

The data was simultaneously published in The New England Journal of Medicine. In August 2024, the U.S. Food and Drug Administration (FDA) granted inebilizumab breakthrough therapy designation for the treatment of IgG4-related disease based on the data from the MITIGATE study, and relevant regulatory procedures are currently being submitted.

MITIGATE (NCT04540497) is being conducted at 80 clinical trial research centers across 22 countries, including China. This is the first randomized, double-blind, placebo-controlled study in IgG4-related disease, establishing the safety and efficacy of inebilizumab in treating IgG4-RD through CD19+B cell depletion.

Research shows that, compared with placebo, the risk of IgG4-RD recurrence was significantly reduced by 87% during the 52-week placebo-controlled period, which is clinically and statistically significant; 7 out of 68 subjects treated with inebilizumab experienced recurrence, while 40 out of 67 subjects treated with placebo experienced recurrence.

The study confirmed the unique mechanism of action of inebilizumab, which can rapidly and continuously deplete the number of peripheral B cells, thereby reducing the levels of disease biomarkers.