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新华制药(000756.SZ):获得醋酸泼尼松龙化学原料药上市申请批准通知书
Ge Long Hui A P P· 2025-11-27 09:14
Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the listing application of Acetate Prednisone, which is primarily used for allergic and autoimmune inflammatory diseases [1] Group 1: Product Approval - The approval notification for Acetate Prednisone indicates its potential market entry, which may enhance the company's product portfolio [1] - The drug is commonly used for conditions such as active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, nephrotic syndrome, thrombocytopenic purpura, and various adrenal cortical insufficiencies [1] - Acetate Prednisone is also utilized in the comprehensive treatment of certain infections, broadening its therapeutic applications [1]
新华制药:醋酸泼尼松龙获批准 2024年相关制剂销售额约 1亿元
Guo Ji Jin Rong Bao· 2025-11-27 09:12
Core Viewpoint - The approval of the acetate prednisolone by the National Medical Products Administration marks a significant development for the company, as it expands its product offerings in the treatment of various inflammatory diseases [1] Company Summary - The company, Xinhua Pharmaceutical, has received the approval for the acetate prednisolone chemical raw material drug listing application, which is primarily used for allergic and autoimmune inflammatory diseases [1] - The drug is currently utilized for conditions such as active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, nephrotic syndrome, thrombocytopenic purpura, neutropenia, various adrenal cortex insufficiencies, severe dermatitis, and acute leukemia, as well as in the comprehensive treatment of certain infections [1] Industry Summary - According to relevant statistics, the sales revenue of acetate prednisolone-related formulations in Chinese public medical institutions is projected to be approximately 100 million RMB in 2024 [1]
新华制药:醋酸泼尼松龙化学原料药上市申请获批准
Zhi Tong Cai Jing· 2025-11-27 08:56
Core Viewpoint - The company, Xinhua Pharmaceutical, has received approval from the National Medical Products Administration for the marketing application of Acetate Prednisone, which is primarily used for allergic and autoimmune inflammatory diseases [1] Group 1: Product Approval - The approval notification allows the company to market Acetate Prednisone as a chemical raw material [1] - This product is indicated for various conditions including active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, nephrotic syndrome, thrombocytopenic purpura, neutropenia, adrenal insufficiency, severe dermatitis, and acute leukemia [1] - Acetate Prednisone is also utilized in the comprehensive treatment of certain infections [1]
新华制药(000756.SZ):醋酸泼尼松龙化学原料药上市申请获批准
智通财经网· 2025-11-27 08:55
Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the marketing application of Acetate Prednisolone, which is primarily used for allergic and autoimmune inflammatory diseases [1] Group 1: Product Approval - The approval includes a notification for the marketing of Acetate Prednisolone as a chemical raw material drug [1] - The drug is indicated for various conditions including active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, nephrotic syndrome, thrombocytopenic purpura, granulocytopenia, adrenal cortical insufficiency, severe dermatitis, and acute leukemia [1] - It is also used in the comprehensive treatment of certain infections [1]
新华制药:获得醋酸泼尼松龙化学原料药上市申请批准
Xin Lang Cai Jing· 2025-11-27 08:53
Core Viewpoint - The approval of the acetate prednisolone raw material drug by the National Medical Products Administration is expected to enhance the company's product line and competitiveness in the hormone drug market [1] Group 1: Company Developments - The company received the approval notice for the acetate prednisolone chemical raw material drug application from the National Medical Products Administration [1] - The application for this raw material drug was submitted in March 2024 and has been accepted for review [1] - The approval is anticipated to enrich the company's hormone product line [1] Group 2: Market Context - The acetate prednisolone is primarily used for allergic and autoimmune inflammatory diseases [1] - The estimated sales revenue for acetate prednisolone formulations in Chinese public medical institutions is approximately 100 million yuan in 2024 [1] - The sales of the drug may be influenced by industry policies and market conditions, indicating potential uncertainties [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
Zhi Tong Cai Jing· 2025-11-27 08:47
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(00719)获得醋酸泼尼松龙化学原料药上市申请批准通知书
智通财经网· 2025-11-27 08:45
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.HK):获得醋酸泼尼松龙化学原料药上市申请批准通知书
Ge Long Hui· 2025-11-27 08:41
Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Acetate Prednisolone, which is primarily used for allergic and autoimmune inflammatory diseases [1] Group 1: Product Approval - The company has been granted a marketing approval notification for Acetate Prednisolone, indicating a significant regulatory milestone [1] - This product is mainly utilized for various conditions including active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, nephrotic syndrome, thrombocytopenic purpura, neutropenia, adrenal insufficiency, severe dermatitis, and acute leukemia [1] - Acetate Prednisolone is also used in the comprehensive treatment of certain infections, showcasing its versatility in therapeutic applications [1]