Hansoh Pharmaceutical has secured approval in its China homeland for CD19 inhibitor inebilizumab in immunoglobulin G4-related disease (IgG4-RD), following positive Phase III MITIGATE trial results showing 87% reduction in disease flare risk versus placebo. The monoclonal antibody (mAb) previously gained approval for neuromyelitis optica spectrum disorder (NMOSD) in 2022. Hansoh licensed Chinese rights from Viela Bio in 2019 before its acquisition by Horizon Therapeutics and subsequently Amgen.

The randomised 160-patient trial demonstrated significant improvement in time to disease flare (HR=0.13) and all key secondary endpoints including complete remission rates. IgG4-RD affects approximately 1 to 5 per 100,000 people, causing progressive multi-organ fibrosis through CD19-positive B-cell mediated inflammation. Inebilizumab joins only one other candidate in Phase III development for this rare autoimmune condition, positioning Hansoh as the leader in this niche therapeutic area.

PharmCube's NextBiopharm® database shows that inebilizumab has consistently led the anti-CD19 mAb race, which includes a total of 9 active programs. Click here to request a free trial for NextBiopharm®.