Core Viewpoint - Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the marketing of fumaric acid volnorex, indicating a significant advancement in its product portfolio and potential revenue growth in the pharmaceutical market [1] Company Summary - Shandong Xinhua Pharmaceutical submitted the registration application for fumaric acid volnorex in March 2024, which was accepted by the National Medical Products Administration [1] - The company received the approval notice for the chemical raw material drug in November 2025, allowing it to commence production [1] Industry Summary - Fumaric acid volnorex is primarily used for treating 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 sales revenue for fumaric acid volnorex-related formulations in Chinese public medical institutions is projected to be approximately RMB 825 million in 2024 [1]
山东新华制药股份获得富马酸伏诺拉生化学原料药上市申请批准通知书