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 injectable penicillin sodium (0.96g, 1.6 million units), which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The injectable penicillin sodium is indicated for various infections caused by sensitive bacteria, including abscesses, bacteremia, pneumonia, and endocarditis [1] - Penicillin is the preferred drug for infections such as hemolytic streptococcal infections, pneumococcal infections, and infections caused by penicillinase-negative staphylococci [1] - The drug is also effective against anthrax, tetanus, gas gangrene, syphilis (including congenital syphilis), leptospirosis, relapsing fever, diphtheria, and in combination with aminoglycosides for treating viridans streptococcal endocarditis [1]

Core Viewpoint - The announcement highlights that Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd.'s subsidiary, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., has received approval for its injectable penicillin sodium product, which is expected to enhance its market competitiveness [1] Group 1 - The product, injectable penicillin sodium 0.96g (1.6 million units), has passed the consistency evaluation for generic drug quality and efficacy [1] - The research and development expenses incurred by Tianxin Pharmaceutical for this product amount to approximately RMB 2.5926 million (unaudited) [1] - The approval is seen as a positive development for the company's product portfolio, potentially increasing its market share [1]

Core Viewpoint - The company Baiyunshan (00874) announced that its subsidiary Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its injectable penicillin sodium 0.96g (1.6 million units), which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The injectable penicillin sodium is indicated for various infections caused by sensitive bacteria, including abscesses, bacteremia, pneumonia, and endocarditis [1] - Penicillin is the first-line drug for infections such as hemolytic streptococcal infections, pneumococcal infections, and infections caused by penicillinase-negative staphylococci [1] - The drug is also effective against anthrax, tetanus, gas gangrene, syphilis (including congenital syphilis), leptospirosis, relapsing fever, diphtheria, and in combination with aminoglycosides for treating viridans streptococcal endocarditis [1]

证券代码：600332 证券简称：白云山 公告编号：2026-008 广州白云山医药集团股份有限公司 关于部分药品在国家组织集采药品协议期满品种 接续采购中拟中选的公告 2 | | | | 染;(8)中枢神经系统感染。 适用于治疗敏感微生物引起的单 | | --- | --- | --- | --- | | | | 0.5g | 一或多重感染：(1)全身性重度感 染；(2)下呼吸道感染(包括肺炎)； | | | | | (3)耳鼻喉感染；(4)尿路感染；(5) | | | | | 皮肤和软组织感染；(6)骨和关节 | | | 注射用头孢他啶 | | 感染；(7)妇科感染；(8)胃肠道、 | | | | | 胆道和腹部感染；(9)血液/腹膜透 | | | | | 析 和 持 续 性 非 卧 床 腹 膜 透 析 | | | | 1.0g | (CAPD)相关感染；(10)中枢神经系 | | | | | 统感染(包括脑膜炎)；(11)预防围 | | | | | 手术期尿路感染。 | | | | | 适用于治疗敏感细菌所致的中耳 | | | | 0.5g | 炎、支气管炎、肺炎等呼吸道感染、 | | | | | 尿路 ...

证券代码：600332 证券简称：白云山 公告编号：2026-007 一、药品的基本情况 药品通用名称：注射用青霉素钠 通知书编号：2026B00785 受理号：CYHB2450644 剂型：注射剂 规格：0.96g（160万单位）（按C16H17N2NaO4S计） 注册分类：化学药品 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》， 注射用青霉素钠0.96g（160万单位）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： 二、药品的相关信息 天心制药注射用青霉素钠0.96g（160万单位）于1991年上市。天 心制药于2024年12月16日向国家药品监督管理局递交注射用青霉素 钠0.96g（160万单位）一致性评价申请，于2024年12月31日获得受理。 药品 ...

注射用青霉素钠适用于敏感菌所致的各类感染，如脓肿、菌血症、肺炎和心内膜炎。其中青霉素为以下 感染的首选药物：溶血性链球菌感染；肺炎链球菌感染；不产青霉素酶葡萄球菌感染；炭疽；破伤风、 气性坏疽等梭状芽孢杆菌感染；梅毒（包括先天性梅毒）；钩端螺旋体病；回归热；白喉；青霉素与氨 基糖苷类药物联合用于治疗草绿色链球菌心内膜炎。 格隆汇2月11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》，注射用青霉素钠0.96g （160万单位）已通过仿制药质量和疗效一致性评价。 ...

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 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。 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》， 注射用青霉素钠0.96g（160万单位）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 ...

Group 1 - The company, Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd., and its subsidiary, Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd., have participated in the national centralized procurement for the continuation of products from the first to eighth batches, with results published on February 10, 2026 [1] - A total of 24 products, including Cefuroxime Sodium Injection and Clindamycin Phosphate Injection, are proposed to be selected for this procurement, which will last until December 31, 2028 [1] - The procurement volume will be based on the demand reported by medical institutions, with pricing determined by a tiered selection process [1] Group 2 - The total projected sales revenue for the selected products in 2024 is approximately RMB 798.19 million, accounting for 1.06% of the company's total revenue for that year [2] - For the first three quarters of 2025, the projected sales revenue is around RMB 550.45 million, representing 0.89% of the company's revenue during that period [2] - If contracts are signed and implemented, it is expected to further increase product sales, enhance market share, and improve the company's brand image, positively impacting future business development [2]

南财智讯2月11日电，白云山公告，其控股子公司广州白云山天心制药股份有限公司收到国家药监局核 准签发的《药品补充申请批准通知书》，注射用青霉素钠通过仿制药质量和疗效一致性评价。 ...

| 序号 | 申报企业 | 药品代码 | 通用名 | 商品名 | 剂型 | 規格 | 转换比 | 包装材质 | 包裝 单位 生产企业名称 | 分包装企 业名称 | 药品上市许可 持有人 | A/B组 | 备注 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 75 | 广州白云山屋群 (药业)股份有限 公司 | ZA10DAA009401 0300423 | 安神补脑液 | 无 | 合剂 | 每支装10ml(含 维生素B15mg) | 12 | 玻璃瓶 | 广州白云山星群 盒 (药业)股份有限公 日 | | 广州白云山星群(药 业)股份有限公司 | | | | | | | | | | 1 | | | | | | | | | | | | | | | | | | | | | | | 据了解，浙江第六批集采合计纳入45个品种，化药33个，中成药12个，严格遵循"技术评审+价格评审"双轨制，将临床疗效、质量可靠性、安全性等核心 指标置于评审首位。为保障临床用药需求与供应稳定性，评审还设置A ...