Hansoh Pharma's XINYUE wins second China approval for IgG4-RD

Hansoh Pharmaceutical Group Company Limited announced on September 1, 2025, that its innovative drug XINYUE (Inebilizumab Injection) received drug registration approval from China's National Medical Products Administration (NMPA) on August 26, 2025. This approval is for the addition of a second indication: immunoglobulin G4-related disease (IgG4-RD) in adult patients. XINYUE was included in the Priority Review and Approval Procedure on February 8, 2025.

XINYUE is a CD19 B-cell depleting antibody. The group secured an exclusive license for the product in Chinese Mainland, Hong Kong, and Macau through a 2019 agreement with Viela Bio. Previously, the NMPA approved XINYUE on March 14, 2022, for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in anti-aquaporin-4 (AQP4) antibody-positive adult patients.

In January 2023, XINYUE was first included in the National Reimbursement Drug List, with successful renewal in November 2024. Furthermore, on May 29, 2025, the NMPA accepted the third biologics license application for XINYUE, targeting generalized myasthenia gravis (gMG) in adult patients.