SHANDONG XINHUA (00719) receives approval notice for the market application of prednisolone acetate chemical raw materials.

Shandong Xinhua (00719) announced that recently, the company received the approval and issuance of the "Chemical Raw Material Drug Market Application Approval Notice" for acetate prednisolone by the National Medical Products Administration. In March 2024, Shandong Xinhua Pharmaceutical submitted the registration application materials for the domestic production of acetate prednisolone as a chemical raw material drug to the Center for Drug Evaluation of the National Medical Products Administration and was accepted. In November 2025, it obtained the "Chemical Raw Material Drug Market Application Approval Notice" with the review conclusion being approved for registration. This product is mainly used for allergic and autoimmune inflammatory diseases. It is now widely used in the treatment of active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, nephrotic syndrome, thrombocytopenic purpura, neutropenic diseases, various adrenal insufficiency diseases, severe dermatitis, acute leukemia, and is also used in the comprehensive treatment of certain infections. According to relevant statistical data, in 2024, the sales of acetate prednisolone-related preparations in Chinese public medical institutions were approximately 100 million RMB.