Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Acetate Prednisolone, indicating a significant advancement in its product portfolio and potential revenue growth in the pharmaceutical market [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 marketing application was granted in November 2025, with the review conclusion being a registration approval [1] Industry Summary - Acetate Prednisolone is primarily used for allergic and autoimmune inflammatory diseases, including active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, nephrotic syndrome, thrombocytopenic purpura, granulocytopenia, various adrenal cortical insufficiencies, severe dermatitis, and acute leukemia, among others [1] - 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(00719)获得醋酸泼尼松龙化学原料药上市申请批准通知书