Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that the National Medical Products Administration (NMPA) has granted priority review status to a new indication approval filing for its Uplizna (inebilizumab), a CD19 monoclonal antibody (mAb) co-developed with US-based Viela Bio Inc. The Chinese firm is seeking approval for the drug to treat immunoglobulin G4-related disease (IgG4-RD).
Drug Background and Global Approvals
Inebilizumab was first approved in the US under the trade name Uplizna for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in June 2020. It has since been registered in Japan and the European Union. Hansoh secured development and commercialization rights to the drug in China through a USD 220 million licensing deal with Viela in May 2019, covering indications including NMOSD and other inflammatory/autoimmune diseases and hematological malignancies. The drug received approval in China in March 2022 for treating aquaporin-4 (AQP4) antibody-positive NMOSD and was included in the National Reimbursement Drug List (NDRL) in January 2023, with the status renewed in November 2024.
Clinical Trial Results
The priority review status was based on positive results from the global pivotal Phase III MITIGATE study, conducted across 80 clinical centers in 22 countries, including China. The study showed that patients treated with inebilizumab had an 87% reduced risk of IgG4-RD recurrence at 52 weeks compared to placebo. The drug rapidly and continuously depletes peripheral B cells, reducing disease biomarkers of IgG4-RD. The MITIGATE trial data led the US Food and Drug Administration (FDA) to award the drug Breakthrough Therapy Designation (BTD) previously.-Fineline Info & Tech
