Core Viewpoint - The approval of fumaric acid volnorasone as a chemical raw material drug by the National Medical Products Administration enhances the company's product line and overall competitiveness in the pharmaceutical market [1][2]. Group 1: Product Approval - The company received the approval notice for fumaric acid volnorasone, with the notification number 2025YS00988 [1]. - The application for the domestic production of fumaric acid volnorasone was submitted in March 2024 and was accepted by the National Medical Products Administration [1]. - The approval for production was granted in November 2025, confirming the product's evaluation conclusion as approved [1]. Group 2: Market Potential - Fumaric acid volnorasone is primarily used for gastroesophageal reflux disease and is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1]. - The estimated sales revenue for fumaric acid volnorasone-related formulations in Chinese public medical institutions is approximately RMB 825 million in 2024 [1]. Group 3: Competitive Advantage - The approval of this product will further enrich the company's product line, thereby enhancing its comprehensive competitiveness in the pharmaceutical industry [2].
新华制药(000756.SZ):获得富马酸伏诺拉生化学原料药上市申请批准通知书