SHANDONG XINHUA (00719) received the "Drug Registration Certificate" for Xiongquyudansuan Capsules.

SHANDONG XINHUA (00719) announced that recently, its wholly-owned subsidiary Shandong Zibo Xinda Pharmaceutical Co., Ltd. (hereinafter referred to as "Xinda Pharmaceutical") has received the "Drug Registration Certificate" issued by the National Medical Products Administration for ursodeoxycholic acid capsules. In January 2024, Xinda Pharmaceutical submitted the application materials for the marketing approval of ursodeoxycholic acid capsules to the Center for Drug Evaluation of the National Medical Products Administration (CDE) and it was accepted. In September 2025, it obtained the "Drug Registration Certificate" with the evaluation conclusion of approval. This product is used for the treatment of gallbladder cholesterol stones (must be stones that can be penetrated by X-rays, and the gallbladder contraction function must be normal); cholestatic liver disease (such as: primary biliary cirrhosis); and bile reflux gastritis. This product belongs to the Class A category of the "National Basic Medical Insurance, Industrial Injury Insurance, and Maternity Insurance Drug List (2024)". According to relevant statistics, the sales of ursodeoxycholic acid in public medical institutions in China in 2024 was approximately RMB 2.155 billion. The announcement stated that the approval of ursodeoxycholic acid capsules applied by Xinda Pharmaceutical in September 2025 is conducive to enriching the company's variety of digestive system drugs and enhancing the company's overall competitiveness.