Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Fumaric Acid Venlafaxine, 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 Venlafaxine 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 Venlafaxine 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 estimated sales revenue for Fumaric Acid Venlafaxine-related formulations in Chinese public medical institutions is approximately RMB 825 million in 2024 [1]
山东新华制药股份(00719)获得富马酸伏诺拉生化学原料药上市申请批准通知书