Core Viewpoint - The company Baiyunshan (600332.SH) announced that its subsidiary Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its drug supplement application, indicating progress in its product development and regulatory compliance [1]. Group 1 - The approved products include injectable Cefoperazone Sodium and Sulbactam Sodium in dosages of 1.0g, 1.5g, and 2.0g, as well as Clindamycin Phosphate Injection in dosages of 2ml: 0.3g and 4ml: 0.6g [1]. - The approved drugs have passed the consistency evaluation of generic drug quality and efficacy, which is a significant milestone for the company [1].

Core Viewpoint - Baiyunshan (600332) announced that its subsidiary Tianxin Pharmaceutical has received approval from the National Medical Products Administration for the supplementary application of two injectable drugs, indicating a successful evaluation of their quality and efficacy consistency as generic drugs [1] Group 1: Product Approval - Tianxin Pharmaceutical's injectable drugs, including Cefoperazone Sodium and Sulbactam Sodium (1.0g, 1.5g, 2.0g) and Clindamycin Phosphate Injection (2ml: 0.3g, 4ml: 0.6g), have passed the consistency evaluation for generic drug quality and efficacy [1] - Cefoperazone Sodium and Sulbactam Sodium is a third-generation cephalosporin antibiotic, suitable for treating respiratory infections caused by sensitive bacteria [1] - Clindamycin Phosphate Injection is primarily used for severe infections caused by sensitive anaerobic bacteria [1]

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 廣州白雲山醫藥集團股份有限公司 （「本公司」） 呈交日期: 2025年9月1日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 00874 | 說明 | 香港聯交所上市 H 股 | | | | | | | | | 法定/註冊股份數目 | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 219,900,000 RMB | | | 1 RMB | | 219,900,000 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 219,900,000 RMB | | | 1 RMB | | 219,900,000 | | 2. 股份 ...

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]

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]

Core Viewpoint - Recently, the company’s subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. (referred to as "Tianxin Pharmaceutical"), received a Drug Production License from the Guangdong Provincial Drug Administration, allowing it to contract manufacture drugs (limited to registered products) and to renovate its small-volume injection production line three [1] Group 1 - Tianxin Pharmaceutical's small-volume injection production line three and oral solid dosage workshop for granules (cephalosporin type) have passed the compliance inspection for drug production quality management standards [1] - The approval of the Drug Production License will help Tianxin Pharmaceutical optimize its production capacity to meet market demand [1] - The impact of this license on the company's current performance is not significant [1]

Core Viewpoint - The company, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., a subsidiary of Baiyunshan (600332)(00874), has received a production license from the Guangdong Provincial Drug Administration, allowing it to produce drugs and renovate its small-volume injection production line, which is expected to optimize capacity and meet market demand [1]. Group 1 - The company has been granted a "Drug Production License" for commissioned drug production limited to registered products [1]. - The renovation of the small-volume injection production line and the solid oral dosage form workshop for cephalosporin production has passed the compliance inspection for drug production quality management standards [1]. - The new license and production capabilities are expected to enhance the company's production capacity to better satisfy market needs [1]. Group 2 - The impact of this license on the company's current performance is not expected to be significant [1].

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]

证券代码：600332 证券简称：白云山 公告编号：2025－065 广州白云山医药集团股份有限公司 关于子公司《药品生产许可证》变更的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏， 并对其内容的真实性、准确性和完整性承担法律责任。 近日，广州白云山医药集团股份有限公司（以下简称"本公司"） 子公司广州白云山天心制药股份有限公司（以下简称"天心药业"） 收到广东省药品监督管理局核准签发的《药品生产许可证》，同意 天心药业委托生产药品（仅限上市注册）和改建小容量注射剂生产 线三；改建后的小容量注射剂生产线三和口服固体制剂车间颗粒剂 （头孢菌素类）生产线均通过了药品生产质量管理规范符合性检查。 现将相关情况公告如下： 一、《药品生产许可证》基本情况 企业名称：广州白云山天心制药股份有限公司 许可证编号：粤 20160024 分类码：AhBhzCh 注册地址：广州市海珠区滨江东路 808 号 发证机关：广东省药品监督管理局 同意天心药业委托广州大光制药有限公司生产玻璃酸钠滴眼液 【规格：0.1%（0.4ml：0.4mg）、0.3%（0.4ml：1.2mg）】、聚乙 烯醇滴眼液 ...

一、药物的基本情况 化学原料药名称：结构甘油三酯 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 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对 其内容的真实性、准确性和完整性承担法律责任。 近日，广州白云山医药集团股份有限公司（以下简称"本公司"）子 公司广州白云山汉方现代药业有限公司（以下简称"白云山汉方"） 收 到国家药品监督管理局签发的结构甘油三酯《化学原料药上市申请批准通 知书》。现将有关情况公告如下： 证券代码：600332 证券简称：白云山 公告编号：2025-064 经查询，目前结构甘油三酯原料药的主要生产厂家有费森尤斯卡比华 瑞制药有限公司、成都精西药业有限责任公司等。根据米内网数据显示， 2024 年结构脂肪乳注射液(C6～24)与结构脂肪乳（20%）/氨基酸（16）/ 葡萄糖（13%）注射液两个制剂品种在国内的销售额为人民币 115,706 万 元。截至目前，白云山汉方在结构甘油三酯原料药研发项目上已投入研发 费用合计约人民币 405 万元（未审计）。 包装规格：20kg/桶，190kg/桶 登记号：Y2023000 ...