Core Viewpoint - Baiyunshan (00874) announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for its supplementary drug application, enhancing the market competitiveness of its products [1] Group 1: Product Approval - Tianxin Pharmaceutical's injectable 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] - The approval is expected to improve the market competitiveness of the aforementioned products [1]

证券代码：600332 证券简称：白云山 公告编号：2025-066 广州白云山医药集团股份有限公司 关于子公司药品通过仿制药一致性评价的公告 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"） 控股子公司广州白云山天心制药股份有限公司（以下简称"天心制药"） 收到国家药品监督管理局核准签发的《药品补充申请批准通知书》， 注射用头孢哌酮钠舒巴坦钠（1.0g、1.5g、2.0g）、克林霉素磷酸酯 注射液（2ml：0.3g、4ml：0.6g）已通过仿制药质量和疗效一致性评 价。现将有关情况公告如下： 一、药品的基本情况 规 格 ： 1.0g （ C25H27N9O8S2 0.5g 与 C8H11NO5S 0.5g ） 、 1.5g （C25H27N9O8S2 1.0g与C8H11NO5S 0.5g）、2.0g（C25H27N9O8S2 1.0g与 C8H11NO5S 1.0g） 注册分类：化学药品 1 药品注册标准编号：YBH22342025（1.0g、2.0g）、YBH22 ...

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」） | 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 | | | | | | | | 已發行股份（不包括庫存股份）數目 | | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | | 219,900,000 | | 0 | | 219,900,000 | | 增加 / 減少 (-) | | | | | | | | | | 本月底結存 | | | | 219,900,000 | | 0 | | 219,900,000 | 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 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完 整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚賴該等內 容而引致的任何損失承擔任何責任。 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條而作出的。 茲刊載廣州白雲山醫藥集團股份有限公司（「本公司」）在上海證券交易所網站(www.sse.com.cn)刊登的 本公司關於子公司藥品通過仿製藥一致性評價的公告之中文全文，僅供參考。 廣州白雲山醫藥集團股份有限公司 董事會 中國廣州，2025年9月1日 於本公告日，本公司董事會成員包括執行董事李小軍先生、程寧女士、程洪進先生、唐和平先生與 黎洪先生，及獨立非執行董事陳亞進先生、黃民先生、黃龍德先生與孫寶清女士。 证券代码：600332 证券简称：白云山 公告编号：2025-066 广州白云山医药集团股份有限公司 关于子公司药品通过仿制药一致性评价的公告 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（ ...

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]