Xinhua Pharmaceutical (00719.HK/000756.SZ) Receives Approval for Prednisolone Acetate

Bulletin Express11-27

Shandong Xinhua Pharmaceutical Company Limited (Xinhua Pharmaceutical) announced that its Prednisolone Acetate has obtained the Notification of Approval of Marketing Application for Chemical Active Pharmaceutical Ingredients from the National Medical Products Administration. The company submitted application materials in March 2024, and the product’s registration was officially approved in November 2025.

Prednisolone Acetate is mainly indicated for the treatment of allergic and autoimmune inflammatory diseases, including active rheumatism, rheumatoid arthritis, systemic lupus erythematosus, severe bronchial asthma, nephrotic syndrome, thrombocytopenic purpura, and various adrenal cortical insufficiencies. It is also used in combined treatment for certain infections. According to the announcement, sales of Prednisolone Acetate in China’s public medical institutions reached around RMB 100 million in 2024.

This new approval is expected to further expand Xinhua Pharmaceutical’s hormone product line. The pharmaceutical sales business remains exposed to changes in industry policies, procurement processes, and the overall market environment, resulting in inherent uncertainties.

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