Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the consistency evaluation of the quality and efficacy of injectable Cefotaxime [1][2] Drug Basic Information - The drug is injectable Cefotaxime with specifications of 0.5g and 1.0g, classified as a chemical drug [1] - The approval notification numbers are 2025B04013 and 2025B04015, with acceptance numbers CYHB2350966 and CYHB2350965 [1] - The drug is produced by Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., located at 808 Binhai East Road, Haizhu District, Guangzhou [1] Drug Related Information - Tianxin Pharmaceutical obtained the registration certificate for injectable Cefotaxime in September 2002 and submitted the consistency evaluation application in December 2023 [3] - Injectable Cefotaxime is a third-generation cephalosporin antibiotic used for treating various infections, including severe systemic infections and respiratory tract infections [3] - The sales revenue for injectable Cefotaxime in 2024 is projected to be RMB 1,431.78 million, with total sales in China expected to reach RMB 185,877 million [3] R&D Investment - As of the announcement date, Tianxin Pharmaceutical has invested approximately RMB 1,036 million in the R&D project for injectable Cefotaxime [4]

Core Viewpoint - The company, Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited, announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the injection of Cefotaxime (0.5g, 1.0g) after passing the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The approval pertains to the injection of Cefotaxime, a third-generation cephalosporin antibiotic, which is used to treat infections caused by sensitive microorganisms, including severe systemic infections and various types of infections such as respiratory, urinary, skin, and central nervous system infections [1] - Tianxin Pharmaceutical obtained the registration certificate for the injection of Cefotaxime in September 2002 and submitted the consistency evaluation application to the National Medical Products Administration in December 2023, which has been accepted [1] - The approval is significant as it enhances the company's product portfolio in the antibiotic segment, potentially increasing its market competitiveness and addressing various infection treatments [1]

Core Viewpoint - Baiyunshan's subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for its injectable Cefoperazone, indicating a successful evaluation of the drug's quality and efficacy consistency as a generic medication [1] Group 1 - Baiyunshan's announcement highlights the approval of injectable Cefoperazone (0.5g, 1.0g) as a third-generation cephalosporin antibiotic [1] - The drug is indicated for the treatment of infections caused by sensitive microorganisms, whether singular or multiple [1]

Core Viewpoint - The company, Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited, announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the injection of Cefotaxime (0.5g, 1.0g) after passing the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The approval pertains to the injection of Cefotaxime, a third-generation cephalosporin antibiotic, which is used to treat infections caused by sensitive microorganisms, including severe systemic infections and various types of infections such as respiratory, urinary, skin, and central nervous system infections [1] - Tianxin Pharmaceutical obtained the registration certificate for the injection of Cefotaxime in September 2002 and submitted the consistency evaluation application to the National Medical Products Administration in December 2023, which has been accepted [1]

Core Viewpoint - Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited's subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the injection of Cefoperazone (0.5g, 1.0g), which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approved product, Cefoperazone injection, 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), ear, nose, and throat infections, urinary tract infections, skin and soft tissue infections, bone and joint infections, gynecological infections, gastrointestinal, biliary, and abdominal infections, blood/peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD)-related infections, central nervous system infections (including meningitis), and prevention of perioperative urinary tract infections [1]

Core Viewpoint - The company has received approval for its injectable Cefoperazone, indicating a significant advancement in its pharmaceutical offerings and potential market impact [1] Group 1 - The company, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., a subsidiary of Baiyunshan, has received the "Drug Supplement Application Approval Notice" from the National Medical Products Administration [1] - The injectable Cefoperazone (0.5g, 1.0g) has passed the consistency evaluation of quality and efficacy for generic drugs [1] - Cefoperazone is a third-generation cephalosporin antibiotic, suitable for treating infections caused by sensitive microorganisms [1]

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3日 药品通用名称：注射用头孢他啶 通知书编号：2025B04013、2025B04015 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：2025-067 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 ...

证券代码：600332 证券简称：白云山 公告编号：2025-067 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》， 注射用头孢他啶（0.5g、1.0g）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 药品通用名称：注射用头孢他啶 通知书编号：2025B04013、2025B04015 受理号：CYHB2350966、CYHB2350965 剂型：注射剂 规格：0.5g（按C22H22N6O7S2计）、1.0g（按C22H22N6O7S2计） 注册分类：化学药品 药品注册标准编号：YBH22912025 原药品批准文号：国药准字H20010254、国药准字H19990365 二、药品的相关信息 天心制药于2002年9月取得注射用头孢他啶（ ...

Core Viewpoint - Recently, the company announced that its subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the supplementary application of injectable Cefotaxime (0.5g, 1.0g), which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The company has a significant development in its pharmaceutical segment with the approval of injectable Cefotaxime [1] - The approval indicates the company's commitment to enhancing its product portfolio and meeting regulatory standards [1] - This development may lead to increased market competitiveness for the company's pharmaceutical products [1]

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]