Core Viewpoint - Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the listing of Acetate Prednisolone as a chemical raw material drug, indicating a significant advancement in its product portfolio and potential market opportunities [1] Company Summary - The company submitted the registration application for Acetate Prednisolone to the National Medical Products Administration's CDE in March 2024, which was accepted [1] - The approval notification for the listing was granted in November 2025, with the review conclusion being a registration approval [1] - Acetate Prednisolone is primarily used for allergic and autoimmune inflammatory diseases, including active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, nephrotic syndrome, and others [1] Industry Summary - The sales revenue of Acetate Prednisolone-related formulations in Chinese public medical institutions is estimated to be approximately RMB 100 million in 2024 [1]
山东新华制药股份获得醋酸泼尼松龙化学原料药上市申请批准通知书