Hansoh Pharma's Xinyue injection application accepted in China

Hansoh Pharmaceutical Group (HKEX: 3692) announced today that its second biologics license application (BLA) for XinYue (Inebilizumab Injection) has been accepted by the National Medical Products Administration (NMPA) in China. The application seeks approval for the treatment of immunoglobulin G4-related disease (IgG4-RD). XinYue, a targeted CD19 B cell-depleting antibody, was previously approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive on March 14, 2022. The company entered into a license agreement with Viela Bio in 2019, granting Hansoh exclusive rights to develop and commercialize the product in mainland China, Hong Kong, and Macao. The product was included in the National Reimbursement Drug List in January 2023 and renewed in November 2024.