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白云山(600332.SH):分公司获得药品补充申请批件
Ge Long Hui· 2025-12-29 11:21
Core Viewpoint - The company, Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited, has received approval from the National Medical Products Administration for a supplemental application regarding the drug Cefuroxime Sodium for injection, which is a second-generation cephalosporin antibiotic with broad-spectrum efficacy against both Gram-negative and Gram-positive bacteria [1] Group 1 - The approved drug, Cefuroxime Sodium, is clinically used for treating respiratory infections, urinary tract infections, and surgical infections [1] - Cefuroxime Sodium is noted for its low renal toxicity and stability against β-lactamase, making it advantageous in clinical applications [1]
白云山:附属广药二期基金与广药资本、广开基金订立设立广药广开基金的合伙协议一
Zhi Tong Cai Jing· 2025-12-29 11:13
Core Viewpoint - The announcement details the establishment of two funds by the subsidiary of Baiyunshan (00874), specifically the Guangyao Guangkai Fund and the Guangyao Liwan Fund, with the first fund's partnership agreement already in effect while the second is pending signature [1] Group 1 - Baiyunshan's subsidiary, Guangyao Phase II Fund, has entered into a partnership agreement for the establishment of the Guangyao Guangkai Fund with Guangyao Capital and Guangkai Fund [1] - The partnership agreement for the Guangyao Guangkai Fund became effective on December 29, 2025, with no changes to its main terms [1] - As of the date of the announcement, the partnership agreement for the Guangyao Liwan Fund has not yet been formally signed, and the company will issue a further announcement upon its signing in accordance with Hong Kong listing rules [1]
白云山(00874):附属广药二期基金与广药资本、广开基金订立设立广药广开基金的合伙协议一
智通财经网· 2025-12-29 11:11
Core Viewpoint - The announcement from Baiyunshan (00874) details the establishment of the Guangyao Guangkai Fund and the Guangyao Liwan Fund through its subsidiary, Guangyao Phase II Fund, in partnership with Guangyao Capital and Guangkai Fund [1] Group 1 - The partnership agreement for the Guangyao Guangkai Fund was signed on December 29, 2025, and became effective on the same day, with no changes to the main terms of the agreement [1] - As of the date of the announcement, the partnership agreement for the Guangyao Liwan Fund has not yet been formally signed [1] - The company will issue a further announcement in accordance with Hong Kong listing rules after the signing of the partnership agreement for the Guangyao Liwan Fund [1]
白云山(00874)分公司获得药品补充申请批件
智通财经网· 2025-12-29 11:06
Core Viewpoint - The company Baiyunshan Pharmaceutical Group has received approval from the National Medical Products Administration for its injectable Cefuroxime Sodium, enhancing its market competitiveness [1] Group 1: Product Approval - Baiyunshan Pharmaceutical's subsidiary received a notification of approval for a supplementary application for injectable Cefuroxime Sodium [1] - The product was officially launched in China in May 2006 and submitted for consistency evaluation in April 2025 [1] Group 2: Product Characteristics - Cefuroxime Sodium is a second-generation cephalosporin effective against a wide range of Gram-negative and Gram-positive bacteria, with advantages such as a broad antibacterial spectrum, lower renal toxicity, and stability against β-lactamase [1] - It is widely used in clinical settings for treating respiratory infections, urinary tract infections, and surgical infections [1] Group 3: Market Position - Injectable Cefuroxime Sodium is included in the National Essential Medicines List (2018) and is classified as a Category B drug under the National Medical Insurance (2025) [1] - The successful completion of the consistency evaluation for the generic drug is expected to enhance the product's market competitiveness [1]
白云山分公司获得药品补充申请批件
Zhi Tong Cai Jing· 2025-12-29 11:06
Core Viewpoint - The company has received approval for its injectable Cefuroxime Sodium from the National Medical Products Administration, enhancing its market competitiveness in the pharmaceutical sector [1] Group 1: Product Approval - The Guangzhou Baiyunshan Pharmaceutical Group Co., Ltd. has received the "Drug Supplement Application Approval Notice" for its injectable Cefuroxime Sodium [1] - The injectable Cefuroxime Sodium was officially launched in China in May 2006 and submitted for consistency evaluation on April 3, 2025, with acceptance received on April 11, 2025 [1] Group 2: Product Characteristics - Cefuroxime Sodium is a second-generation cephalosporin effective against most Gram-negative and Gram-positive bacteria, known for its broad antibacterial spectrum, low renal toxicity, and stability against β-lactamase [1] - The drug is widely used in clinical settings for treating respiratory infections, urinary tract infections, and surgical infections [1] Group 3: Market Position - Injectable Cefuroxime Sodium is included in the National Essential Medicines List (2018) and classified as a Category B drug under the National Medical Insurance (2025) [1] - The successful completion of the generic drug consistency evaluation is expected to enhance the market competitiveness of the product [1]
白云山(600332) - 广州白云山医药集团股份有限公司关于附属企业参与投资设立广州广药广开创业投资基金合伙企业(有限合伙)暨关联交易的进展公告
2025-12-29 11:01
| 投资标的名称 | 广州广药广开创业投资基金合伙企业(有限 合伙) | | | --- | --- | --- | | 投资金额(万元) | 9,750 | | | 投资进展阶段 | 完成 交易要素变更 进展 | 终止 | | 特别风险提示 | 广州广药广开创业投资基金合伙企业(有限 | | | | 合伙)尚需履行工商注册登记、中国证券投 | | | | 资基金业协会登记备案等手续,实施过程尚 | | | | 存在不确定性。 | | 一、基本情况概述 2025 年 12 月 22 日,广州白云山医药集团股份有限公司("本公司")召 开第九届董事会第三十二次会议,审议通过了《关于广州广药二期基金股权投资 合伙企业(有限合伙)认购广州广药广开创业投资基金合伙企业(有限合伙)有 限合伙份额暨关联交易的议案》,同意本公司附属企业广州广药二期基金股权投 资合伙企业(有限合伙)("广药二期基金")与广州广药资本私募基金管理有 限公司("广药资本")、广州开发区投资基金管理有限公司("广开基金") 证券代码:600332 证券简称:白云山 公告编号:2025-096 广州白云山医药集团股份有限公司 关于附属企业参 ...
白云山(600332) - 广州白云山医药集团股份有限公司关于分公司获得药品补充申请批件的公告
2025-12-29 11:01
证券代码:600332 证券简称:白云山 公告编号:2025-095 广州白云山医药集团股份有限公司 关于分公司获得药品补充申请批件的公告 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") 分公司广州白云山医药集团股份有限公司白云山制药总厂(以下简称 "白云山制药总厂") 收到国家药品监督管理局签发的《药品补充 申请批准通知书》。现将有关情况公告如下: 一、药品的基本情况 (一)注射用头孢呋辛钠(规格 0.25g、1.25g、1.75g、2.0g) 药品通用名称:注射用头孢呋辛钠 触药品的包装材料和容器。 审批结论:根据《中华人民共和国药品管理法》《国务院关于改 革药品医疗器械审评审批制度的意见》(国发〔2015〕44 号)、《关 于仿制药质量和疗效一致性评价工作有关事项的公告》(2017 年第 100 号)和《国家药监局关于开展化学药品注射剂仿制药质量和疗效 一致性评价工作的公告》(2020 年第 62 号)的规定,经审查,本品 通过仿制药质量和疗效一致性评价。同时同 ...
白云山(00874) - 海外监管公告
2025-12-29 11:00
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 本公司關於分公司獲得藥品補充申請批件的公告之中文全文,僅供參考。 廣州白雲山醫藥集團股份有限公司 董事會 一、药品的基本情况 (一)注射用头孢呋辛钠(规格 0.25g、1.25g、1.75g、2.0g) 药品通用名称:注射用头孢呋辛钠 中國廣州,2025年12月29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、陳傑輝先生、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:2025-095 近日,广州白云山医药集团股份有限公司(以下简称"本公司") 分公司广州白云山医药集团股份有限公司白云山 ...
白云山(00874) - 关连交易进展公告 - 参与设立广药广开基金和广药荔湾基金
2025-12-29 10:57
截至本公告日期,有關設立廣藥荔灣基金的合夥協議二尚未正式簽署。本公司將根據香港上市規則 之規定於合夥協議二簽署後另行刊發公告。本公司股東及潛在投資者於買賣本公司股份時,務請審 慎行事。 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。 關連交易進展公告 參與設立廣藥廣開基金和廣藥荔灣基金 茲提述廣州白雲山醫藥集團股份有限公司(「本公司」)日期為2025年12月22日之公告(「該公告」),內 容有關本公司附屬企業廣藥二期基金參與設立廣藥廣開基金和廣藥荔灣基金之關連交易。除另有界 定外,本公告所用詞彙與該公告所界定者具有相同涵義。 董事會欣然宣佈於2025年12月29日,廣藥二期基金與廣藥資本、廣開基金訂立了有關設立廣藥廣開 基金的合夥協議一。合伙協議一於同日正式生效,合夥協議一的主要條款並無任何變更。合夥協議 一的主要條款及本次投資詳情載於該公告。 董事會 中國廣州,2025年12月29日 於本公告日,本公司董事會成員包括 ...
白云山(00874.HK):白云山生物收到冻干人用狂犬病疫苗(Vero细胞)《药品注册证书》
Jin Rong Jie· 2025-12-28 13:28
Core Viewpoint - Recently, the company announced that its subsidiary, Guangzhou Baiyunshan Biological Products Co., Ltd. (referred to as "Baiyunshan Biological"), received approval from the National Medical Products Administration for the drug registration certificate of the freeze-dried human rabies vaccine (Vero cells) [1] Group 1 - The company has successfully obtained a drug registration certificate for its rabies vaccine, indicating a significant milestone in its product development [1] - This approval may enhance the company's product portfolio and strengthen its position in the biopharmaceutical market [1]