Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., has received approval for its generic drugs to pass the consistency evaluation of quality and efficacy, which is expected to enhance market competitiveness for the products [1][11]. Drug Information 1. Cefoperazone Sodium and Sulbactam Sodium Injection - The drug has been approved in three specifications: 1.0g, 1.5g, and 2.0g [1][6] - It is a third-generation cephalosporin antibiotic used for various infections, including respiratory, urinary, and intra-abdominal infections [6] - The product was originally developed by Pfizer and was first launched in Japan in June 1986, with its 1.0g specification approved in China in 1996 [6] - The sales revenue for Tianxin Pharmaceutical's cefoperazone sodium and sulbactam sodium injection in 2024 is projected to be RMB 15.897 million [7] - The company has invested approximately RMB 7.9186 million in the research and development of this product [7] 2. Clindamycin Phosphate Injection - The drug is available in two specifications: 2ml: 0.3g and 4ml: 0.6g, and was launched in 2006 [8][9] - It is primarily used for severe infections caused by sensitive anaerobic bacteria [9] - The sales revenue for Tianxin Pharmaceutical's clindamycin phosphate injection in 2024 is projected to be RMB 7.50787 million [10] - The company has invested approximately RMB 2.7329 million in the research and development of this product [10]

Trading Information Summary - On September 1, 2025, Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited (600332) closed at 26.61 yuan, up 0.23%, with a turnover rate of 1.73% and a trading volume of 243,300 shares, amounting to a transaction value of 651 million yuan [1] - On the same day, the net outflow of main funds was 27.59 million yuan, accounting for 4.24% of the total transaction value; the net outflow of retail funds was 25.91 million yuan, accounting for 3.98% of the total transaction value; while retail investors saw a net inflow of 53.50 million yuan, accounting for 8.22% of the total transaction value [1][3] Company Announcements Summary - Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited's subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the consistency evaluation of generic drugs for two products: injectable cefoperazone sodium and sulbactam sodium (1.0g, 1.5g, 2.0g) and clindamycin phosphate injection (2ml: 0.3g, 4ml: 0.6g) [2] - The domestic sales revenue for injectable cefoperazone sodium and sulbactam sodium is projected to be 688.93 million yuan in 2024, with Tianxin Pharmaceutical's sales revenue for this product at 15.90 million yuan and R&D expenses around 7.92 million yuan [2] - The domestic sales revenue for clindamycin phosphate injection is expected to be 13.51 million yuan in 2024, with Tianxin Pharmaceutical's sales revenue for this product at 7.51 million yuan and R&D expenses approximately 2.73 million yuan [2]

Core Viewpoint - Baiyunshan (600332.SH) announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the supplementary application of two injectable drugs, indicating a successful consistency evaluation of quality and efficacy for generic drugs [1] Group 1: Product Approval - The injectable drugs approved include Cefoperazone Sodium and Sulbactam Sodium (1.0g, 1.5g, 2.0g) and Clindamycin Phosphate Injection (2ml: 0.3g, 4ml: 0.6g) [1] - Cefoperazone Sodium and Sulbactam Sodium is a third-generation cephalosporin antibiotic, effective against respiratory infections, urinary tract infections, and various intra-abdominal infections among others [1] - Clindamycin Phosphate Injection is primarily used for severe infections caused by sensitive anaerobic bacteria [1]

Core Viewpoint - Baiyunshan's subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for two injectable drugs, indicating a successful step in the company's pharmaceutical development and regulatory compliance [1] Group 1: Drug Approvals - The approved drugs include injectable Cefoperazone Sodium and Sulbactam Sodium (1.0g, 1.5g, 2.0g) and Clindamycin Phosphate Injection (2ml: 0.3g, 4ml: 0.6g) [1] - Cefoperazone Sodium and Sulbactam Sodium is a third-generation cephalosporin antibiotic, effective against respiratory infections caused by sensitive bacteria [1] - Clindamycin Phosphate Injection is primarily used for severe infections caused by sensitive anaerobic bacteria [1]

Group 1 - The report details the changes in the registered capital of Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited as of August 31, 2025, with a total registered capital of RMB 1,625,790,949 [1] - The number of issued shares for H shares listed on the Hong Kong Stock Exchange remains at 219,900,000, with no changes reported [1] - The number of issued shares for A shares listed on the Shanghai Stock Exchange is 1,405,890,949, also showing no changes [1] Group 2 - The report confirms that all securities issuance or stock sales have been formally authorized by the board of directors and comply with applicable listing rules and regulations [2] - The issuer has received all payments due from the securities issuance or stock sales [2] - All necessary documents have been filed with the relevant authorities as required by law [2]

Core Viewpoint - Baiyunshan (00874) announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. ("Tianxin Pharmaceutical"), has received approval from the National Medical Products Administration for its supplementary drug application, indicating that its injectable formulations of 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] Group 1 - Tianxin Pharmaceutical's injectable formulations have successfully passed the consistency evaluation, which will enhance the market competitiveness of these products [1]

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（ ...