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]

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。 ...

格隆汇9月1日丨白云山(600332.SH)公布，公司控股子公司广州白云山天心制药股份有限公司（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。 ...

注射用头孢哌酮钠舒巴坦钠为第三代头孢菌素抗生素，适用于敏感菌所致的呼吸道感染等。克林霉素磷 酸酯注射液主要用于由敏感厌氧菌引起的严重感染。 人民财讯9月1日电，白云山(600332)9月1日晚间公告，公司控股子公司天心制药近日收到国家药监局核 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。 转自：证券时报 ...

Group 1 - The company is building a three-dimensional research and innovation system focusing on short, medium, and long-term goals, actively introducing quality projects and innovative technologies in the short to medium term [1] - The technology center continues to conduct research on new drug imitation and innovation, enhancing the company's product portfolio and competitiveness in specific fields [1] - The company is advancing the development of innovative technologies and products such as nano carbon iron in the long term, and is promoting the independent research and development of cell immunotherapy and personalized innovative medical technologies by its affiliate [1] Group 2 - In the reporting period, the company obtained approvals or supplementary application approvals for various products, including Clindamycin Phosphate Injection and Naloxone Hydrochloride Injection, and passed consistency evaluations [1] - The company’s product Esomeprazole Magnesium Enteric-coated Capsules and others were selected for provincial centralized procurement projects, enhancing market share [1] - Laimei Pharmaceutical reported a revenue of 377 million yuan for the first half of 2025, focusing on consolidating the leading position of its flagship product, Kanalin, in its niche market [2]

Core Viewpoint - Laimei Pharmaceutical reported a revenue of 198 million yuan for Q1 2025, marking a year-on-year increase of 9.54%, but faced a net loss of 13.78 million yuan due to intensified market competition and rising R&D costs [2][3] Group 1: Financial Performance - The company achieved a revenue of 198 million yuan, reflecting a year-on-year growth of 9.54% [2] - The net profit attributable to shareholders was -13.78 million yuan, indicating an increase in losses compared to the previous year [2] Group 2: Strategic Focus - Laimei Pharmaceutical is focusing on its strengths in traditional therapeutic areas such as oncology, digestive system, and specialty drugs, while enhancing the marketing of its core product, Kanalin [2] - The company is actively expanding Kanalin's market beyond thyroid indications and is pursuing international sales to increase global market share [2] Group 3: R&D and Innovation - The company has maintained a path of independent innovation, with R&D investment reaching 13.77 million yuan, a year-on-year increase of 33.71% [3] - Several innovative projects, including a nano carbon iron injection and personalized tumor vaccines, are progressing smoothly, ensuring a robust pipeline for future growth [3] - The company has successfully registered new drugs, including Nicorandil and Clindamycin Phosphate Injection, contributing to a more diversified product structure [3]