SHANDONG XINHUA (00719) has obtained the approval notice for the application for listing of Fumarate Funnorla biochemical raw materials.

SHANDONG XINHUA (00719) announced that recently, Shandong Xinhua Limited (Shandong Xinhua Pharmaceutical or the Company) has received the approval and issuance of the Approval Notification Letter for the market application of Fumarate Furolate (the Product) as a chemical raw material drug by the National Medical Products Administration. In March 2024, Shandong Xinhua Pharmaceutical submitted the application for domestic production of Fumarate Furolate as a chemical raw material drug to the Center for Drug Evaluation (CDE) of the National Medical Products Administration and it was accepted. In November 2025, the Company obtained the Approval Notification Letter for the market application of the chemical raw material drug, with the conclusion that the production of the Product is approved. The Product is mainly used for reflux esophagitis, and it is listed as a Category B drug in the "National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalogue (2025)". According to relevant statistics, the sales of related formulations of Fumarate Furolate in Chinese public medical institutions in 2024 were approximately RMB 825 million.