Hansoh Pharma's Inebilizumab (Xinyue) Receives NMPA Acceptance for Second Indication in IgG4-Related Disease

On March 4, Hansoh Pharmaceutical Group Company Limited announced that the second Biologics License Application (BLA) for昕越（Inebilizumab Injection）has been accepted by the National Medical Products Administration (NMPA) for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD). This indication was granted priority review and approval by the NMPA on February 8, 2025.

The acceptance of the new indication application for Sinovant's product is based on the positive results from the global pivotal Phase III trial, MITIGATE. In November 2024, the data was published in The New England Journal of Medicine. In August 2024, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation for Inebilizumab for the treatment of IgG4-related disease based on the MITIGATE study data, and relevant regulatory procedures are currently underway.

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, confirming the safety and efficacy of inebilizumab in treating IgG4-RD through CD19+B cell depletion.

In March 2022, the first indication of Xinyue was approved for marketing in China, for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin-4 (AQP4) antibodies. It was included in the National Reimbursement Drug List (NRDL) for the first time in the same year and successfully renewed in November 2024.