Hansoh Pharma's XinYue gains priority review for new indication

Hansoh Pharmaceutical Group (HKEX: 3692) announced that its XinYue (inebilizumab injection) has been included in the priority review and approval procedure by China's National Medical Products Administration (NMPA) for the treatment of immunoglobulin G4-related disease (IgG4-RD). The decision on February 8, 2025, was based on positive results from the global pivotal Phase III MITIGATE trial. Inebilizumab is a targeted CD19 B cell-depleting antibody. Hansoh entered into a license agreement with Viela Bio in 2019 for the development and commercialization of the product in mainland China, Hong Kong, and Macao. XinYue was initially approved in China in March 2022 for neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. It was included in the National Reimbursement Drug List in January 2023.