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广州白云山医药集团股份有限公司关于子公司获得化学原料药上市申请批准通知书的公告
Group 1 - Guangzhou Baiyunshan Pharmaceutical Group's subsidiary, Baiyunshan Hanfang Modern Pharmaceutical Co., received approval for the listing application of chemical raw material triglycerides from the National Medical Products Administration [1][2] - The approved chemical raw material, triglycerides, is a key ingredient for formulations such as structured fat emulsion injections and is used for parenteral nutrition in patients unable to take oral or enteral nutrition [2] - Baiyunshan Hanfang has invested approximately RMB 4.05 million in the research and development of triglyceride raw materials [2] Group 2 - Baiyunshan Tianxin Pharmaceutical Co., another subsidiary, received a revised drug production license from the Guangdong Provincial Drug Administration, allowing it to produce and modify small-volume injection production lines [5][6] - The production license includes the ability to produce various forms of medications, including tablets, capsules, and small-volume injections, with a validity period until August 4, 2030 [5][6] - The changes in the production license are expected to optimize Tianxin's production capacity and meet market demand [7]
白云山(00874):白云山汉方获得结构甘油三酯《化学原料药上市申请批准通知书》
Zhi Tong Cai Jing· 2025-08-29 09:31
Core Viewpoint - Company subsidiary Guangzhou Baiyunshan Hanfang Modern Pharmaceutical Co., Ltd. has received the approval notice for the listing application of structured triglycerides from the National Medical Products Administration, indicating compliance with national drug review technical standards and enabling production and sales [1] Group 1: Product Approval - The approval pertains to structured triglycerides, which are key raw materials for formulations such as structured fat emulsion injection (C6–24) and structured fat emulsion (20%)/ amino acids (16)/ glucose (13%) injection [1] - Structured triglycerides are suitable for patients who cannot, insufficiently, or are contraindicated from oral or enteral nutrition, providing parenteral nutrition fat supplementation [1] Group 2: Market Impact - The approval will enrich the company's medicinal lipid raw material product offerings and enhance the market competitiveness of Baiyunshan Hanfang's lipid raw material products [1] - The approval is not expected to have a significant impact on the company's current performance [1]
白云山:白云山汉方获得结构甘油三酯《化学原料药上市申请批准通知书》
Zhi Tong Cai Jing· 2025-08-29 09:25
Core Viewpoint - Baiyunshan's subsidiary, Guangzhou Baiyunshan Hanfang Modern Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the listing application of structured triglycerides as a chemical raw material drug, indicating compliance with national drug review technical standards and enhancing the company's product competitiveness in the market [1] Group 1 - The approval allows Baiyunshan Hanfang to produce and sell structured triglycerides, which are key raw materials for various nutritional injection formulations [1] - Structured triglycerides are suitable for patients who cannot, insufficiently, or are contraindicated from oral or enteral nutrition, providing parenteral nutrition supplementation of fats [1] - The approval is expected to enrich Baiyunshan Hanfang's medicinal lipid raw material product offerings, further enhancing the company's market competitiveness in lipid raw materials [1] Group 2 - The approval of the chemical raw material drug listing does not have a significant impact on the company's current performance [1]
白云山:子公司获化学原料药上市申请批准
Xin Lang Cai Jing· 2025-08-29 08:21
Core Viewpoint - The approval of the structural triglyceride by the National Medical Products Administration enhances the product portfolio of Guangzhou Baiyunshan Hanfang Modern Pharmaceutical Co., Ltd, improving its market competitiveness in lipid excipients, although it will not have a significant impact on current performance [1] Group 1 - Guangzhou Baiyunshan Hanfang Modern Pharmaceutical Co., Ltd received the approval notice for structural triglyceride from the National Medical Products Administration [1] - The raw material is a key ingredient for formulations such as structured fat emulsion injection (C6–24) and structured fat emulsion (20%)/amino acids (16)/glucose (13%) injection, which are used for parenteral nutrition fat supplementation [1] - The domestic sales revenue for these formulations is projected to be 1.157 billion yuan in 2024 [1] Group 2 - The company has invested approximately 4.05 million yuan in research and development for this project [1] - The approval will enrich the company's medicinal lipid excipient product offerings [1] - The impact of this approval on the company's current performance is not significant [1]