SHANDONG XINHUA (00719) announced that it recently received the "Chemical Drug API Marketing Approval Notice" for Prednisolone Acetate from the National Medical Products Administration (NMPA).

In March 2024, the company submitted the registration application for the domestic production of Prednisolone Acetate as a chemical active pharmaceutical ingredient (API) to the NMPA's Center for Drug Evaluation (CDE), which was subsequently accepted. The approval notice was granted in November 2025, with the review conclusion confirming the registration.

Prednisolone Acetate is primarily used for allergic and autoimmune inflammatory diseases, including active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, nephrotic syndrome, thrombocytopenic purpura, granulocytopenia, adrenal cortex insufficiency, severe dermatitis, and acute leukemia. It is also applied in the comprehensive treatment of certain infections.

According to relevant statistics, sales of Prednisolone Acetate-related formulations in China's public medical institutions reached approximately RMB 100 million in 2024.