Hansoh Pharmaceutical’s product Xinyue’s new indication is included in the priority review and approval process by NMPA
February 11, 2025
Source: drugdu
29
On February 10, Hansoh Pharmaceutical (03692) issued an announcement, announcing that its product Xinyue® (inelizumab injection) was included in the priority review and approval process by the National Medical Products Administration (NMPA) on February 8, 2025 for the new indication of treating immunoglobulin G4-related diseases (IgG4-RD) due to the positive results of the global pivotal Phase III trial MITIGATE.
Xinyue® signed a license agreement with Viela Bio on May 24, 2019, obtaining exclusive licenses for development and commercialization in mainland China, Hong Kong and Macau. The product was approved for marketing by NMPA on March 14, 2022, and is suitable for adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin 4 (AQP4) antibodies. In January 2023, the product was included in the "National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug List" for the first time and was successfully renewed in November 2024.
https://finance.eastmoney.com/a/202502103314676122.html
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