HANSOH PHARMA(HK:03692) Jing Ji Guan Cha Wang·2025-09-02 05:37Core Viewpoint - Hansoh Pharmaceutical (03692) announced that its innovative drug, XinYue (Inalizumab injection), received a drug registration certificate from the National Medical Products Administration (NMPA) of China on August 26, 2025, for an additional indication: treatment of adult patients with Immunoglobulin G4-related disease (IgG4-RD) [1] Group 1 - XinYue is a targeted CD19B cell-depleting antibody [1] - The product was licensed in 2019 through an agreement with VielaBio for exclusive development and commercialization rights in mainland China, Hong Kong, and Macau [1] - In March 2022, XinYue was approved by NMPA for marketing in China for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD) [1] Group 2 - In January 2023, XinYue was included in the National Basic Medical Insurance Drug List for the first time [1] - The additional indication for IgG4-RD was prioritized for review and approval on February 8, 2025 [1]