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 injection of Cefoperazone (0.5g, 1.0g), which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The approved drug, Cefoperazone, is a third-generation cephalosporin antibiotic [1] - Cefoperazone is indicated for the treatment of infections caused by sensitive microorganisms, including severe systemic infections, lower respiratory tract infections (including pneumonia), ENT infections, urinary tract infections, skin and soft tissue infections, bone and joint infections, gynecological infections, gastrointestinal, biliary, and abdominal infections, blood/peritoneal dialysis, and central nervous system infections (including meningitis) [1] - The drug is also used for the prevention of perioperative urinary tract infections [1]

Group 1 - Baiyunshan's stock price increased by 0.45% on September 2, with a trading volume of 392 million yuan [1] - The financing buy-in amount for Baiyunshan on the same day was 52.78 million yuan, while the financing repayment was 75.43 million yuan, resulting in a net financing outflow of 22.65 million yuan [1] - As of September 2, the total financing and securities lending balance for Baiyunshan was 1 billion yuan, with the financing balance accounting for 2.65% of the circulating market value, indicating a high level compared to the past year [1] Group 2 - Baiyunshan's main business includes the research, development, manufacturing, and sales of traditional Chinese and Western medicines, chemical raw materials, and health products, with major revenue sources being large commercial (69.32%), health (16.79%), and traditional medicine (12.53%) [2] - For the first half of 2025, Baiyunshan reported a revenue of 41.835 billion yuan, a year-on-year increase of 1.93%, while the net profit attributable to shareholders was 2.516 billion yuan, a decrease of 1.31% year-on-year [2] Group 3 - Baiyunshan has distributed a total of 10.256 billion yuan in dividends since its A-share listing, with 3.708 billion yuan distributed in the last three years [3] - As of June 30, 2025, the top ten circulating shareholders of Baiyunshan included Hong Kong Central Clearing Limited and several ETFs, with notable changes in shareholding among these entities [3]

证券代码：600332 证券简称：白云山 公告编号：2025-066 （一）注射用头孢哌酮钠舒巴坦钠 药品通用名称：注射用头孢哌酮钠舒巴坦钠 通知书编号：2025B03888、2025B03891、2025B03893 受理号：CYHB2350978、CYHB2350964、CYHB2350979 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 剂型：注射剂 规格：1.0g（C25H27N9O8S2 0.5g与C8H11NO5S 0.5g）、1.5g（C25H27N9O8S2 1 ...

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]

天心制药的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和4ml： 0.6g)通过仿制药一致性评价，将有利于提升上述产品的市场竞争力。 智通财经APP讯，白云山(00874)发布公告，近日，公司控股子公司广州白云山天心制药股份有限公司 ("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。 ...

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 ...