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国家药监局持续深化化妆品监管;华纳药厂撤回一份药品注册申请
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-30 00:40
Group 1: Regulatory Developments - The National Medical Products Administration (NMPA) held a meeting to summarize the regulatory achievements of 2025 and discuss key work for 2026, emphasizing the need for comprehensive regulatory reforms in the cosmetics industry [1] - The meeting highlighted that the Chinese cosmetics market is projected to reach a total transaction value of 1,073.82 billion yuan in 2024, indicating continuous market expansion [1] - Despite the growth, the industry faces structural issues, with over 20,000 registered cosmetics companies but low market concentration and a lack of globally influential brands [1] Group 2: Clinical Innovations and Approvals - The first non-injection epinephrine product, Neffy® (优敏速®), has been approved in China for emergency treatment of severe allergic reactions, marking a significant milestone in drug innovation [4] - HaiXiang Pharmaceutical announced the initiation of Phase II clinical trials for NWRD06, a novel nucleic acid drug aimed at preventing liver cancer recurrence, which is the first of its kind targeting the GPC3 marker [5] - Xinhua Medical received registration for two types of medical devices, enhancing its competitiveness in the in vitro diagnostics market [6] Group 3: Financing and Market Expansion - Beijing Ruifeng Biotechnology completed a C-round financing of over 100 million yuan, aimed at expanding its commercial capabilities and enhancing research and development in both human and animal health [8][9] - Humatrix Medical announced the completion of an A+ round financing of over 100 million yuan, which will be used to advance clinical trials for its core product and expand its product pipeline [10] Group 4: Healthcare Insurance and Spending - The National Healthcare Security Administration reported that from January to November 2025, the total income of the basic medical insurance fund reached 2.632 trillion yuan, with total expenditures of 2.110 trillion yuan, indicating stable fund operations [12]
华纳药厂:关于撤回药品注册申请的公告
Zheng Quan Ri Bao· 2025-12-29 13:58
Core Viewpoint - Warner Pharmaceuticals has received approval from the National Medical Products Administration to withdraw its registration application for the silicone emulsion product [2] Group 1 - Warner Pharmaceuticals announced the receipt of a termination notice for its drug registration application [2] - The company has decided to withdraw its application for the silicone emulsion product [2]
华纳药厂(688799) - 自愿披露关于撤回药品注册申请的公告
2025-12-29 09:30
湖南华纳大药厂股份有限公司 自愿披露关于撤回药品注册申请的公告 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、准确性和完整性依法承担法律责任。 证券代码:688799 证券简称:华纳药厂 公告编号:2025-101 公司于 2025 年 1 月向国家药品监督管理局递交该产品的上市许可申请并获 得受理。经审慎研究,结合研发策略,公司决定主动撤回本次药品注册申请。 该药品注册申请的主动撤回并终止不会对公司当期及未来生产经营与业绩 产生重大影响。敬请广大投资者注意投资风险。 特此公告。 湖南华纳大药厂股份有限公司董事会 2025 年 12 月 30 日 近日,湖南华纳大药厂股份有限公司(以下简称"公司")收到国家药品监 督管理局核准签发的《药品注册申请终止通知书》,同意公司撤回西甲硅油乳剂 的注册申请。现将相关情况公告如下: | 药品名称 | 注册分类 | 受理号 | 通知书编号 | 审批结论 | | --- | --- | --- | --- | --- | | 西甲硅油 | 化学药品 | | | 根据《药品注册管理办法》第八十九条以 及申请人的撤回申请《关于 ...
华纳药厂(688799.SH):撤回药品注册申请
Ge Long Hui A P P· 2025-12-29 09:16
Core Viewpoint - Warner Pharmaceuticals (688799.SH) has voluntarily withdrawn its drug registration application for Simethicone Emulsion, which is primarily used to alleviate discomfort caused by excessive gas in the gastrointestinal tract [1] Group 1: Company Actions - The company received a termination notice from the National Medical Products Administration (NMPA) regarding the drug registration application [1] - The decision to withdraw the application was made after careful consideration of the research and development strategy [1] Group 2: Product Information - Simethicone Emulsion is used for treating symptoms such as abdominal bloating and can also be utilized as an auxiliary medication for abdominal imaging examinations [1] - The product was initially submitted for market approval in January 2025 and had received acceptance from the NMPA [1]
华纳药厂:主动撤回西甲硅油乳剂药品注册申请
Xin Lang Cai Jing· 2025-12-29 09:07
Core Viewpoint - Warner Pharmaceuticals (688799.SH) has received approval from the National Medical Products Administration to withdraw its drug registration application for Silicones Emulsion, which is primarily used to treat discomfort symptoms caused by excessive gas in the gastrointestinal tract, such as bloating [1] Group 1 - The company submitted the marketing authorization application for the product in January 2025 and received acceptance [1] - The decision to voluntarily withdraw the drug registration application will not have a significant impact on the company's current and future production operations and performance [1]
华纳药厂(688799.SH):拟购买、出售资产
Ge Long Hui A P P· 2025-12-26 15:57
Core Viewpoint - Warner Pharmaceuticals (688799.SH) is advancing its "combination of generic and innovative drugs" development strategy by focusing on enhancing its core competitiveness through self-research, collaborative research, and investment incubation [1] Group 1: Strategic Development - The company is implementing a strategy that integrates generic drug development with innovative drug breakthroughs, aligning with industry trends and its own business development strategy [1] - The subsidiary, Qianlie Pharmaceuticals, is focusing on the ophthalmic medication sector, optimizing its product layout, and developing market-potential ophthalmic drugs [1] Group 2: Transaction Details - The company plans to purchase five formulation projects from Qianlie Pharmaceuticals, including Indocyanine Green Injection and Sodium Fluorescein Injection, for a total price of 10.1 million yuan, funded by the company's own resources [1] - The company intends to sell four formulation projects, including Diquafosol Sodium Eye Drops, to Qianlie Pharmaceuticals for a total price of 7 million yuan [1]
华纳药厂:拟购买、出售资产
Ge Long Hui· 2025-12-26 15:45
Group 1 - The core strategy of the company is to advance the "combination of generic and innovative drugs" by focusing on "intensive consolidation of generics" and "spot breakthroughs in innovative drugs" to enhance its core competitiveness [1] - The subsidiary, Qianlie Pharmaceutical, is focused on the ophthalmic medication sector, continuously optimizing its product layout and developing promising ophthalmic drugs [1] - The company plans to optimize its formulation product pipeline through the integration with Qianlie Pharmaceutical, aligning with its strategic planning and industrial positioning [1] Group 2 - The company intends to purchase five formulation projects from Qianlie Pharmaceutical, including injection products such as Indocyanine Green and Sodium Fluorescein, for a total consideration of 10.1 million yuan, funded by its own resources [1] - The company also plans to sell four formulation projects, including Diquafosol Sodium Eye Drops, to Qianlie Pharmaceutical for a total consideration of 7 million yuan [1]
华纳药厂:拟购买5个制剂项目的技术、出售4个制剂项目的技术
Mei Ri Jing Ji Xin Wen· 2025-12-26 11:40
Group 1 - Warner Pharmaceuticals announced the acquisition of technology for 5 formulation projects from Zhuhai Qianlie Pharmaceutical Co., Ltd. for RMB 10.1 million and the transfer of technology for 4 formulation projects for RMB 7 million [1] - The transaction is classified as a related party transaction and does not constitute a major asset reorganization, having been approved by the company's board without the need for shareholder approval [1] - As of the report date, Warner Pharmaceuticals has a market capitalization of RMB 6.3 billion [1] Group 2 - For the fiscal year 2024, Warner Pharmaceuticals' revenue composition is 99.01% from pharmaceutical manufacturing and 0.99% from other businesses [1]
华纳药厂(688799) - 关于购买、出售资产暨关联交易的公告
2025-12-26 11:31
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。 重要内容提示: 湖南华纳大药厂股份有限公司(以下简称"公司"、"华纳药厂")拟 向珠海前列药业有限公司(以下简称"前列药业")以人民币 1,010 万元购买 5 个制剂项目的技术(包括上市许可持有人、所有权、使用权和转让权等,下同), 并以人民币 700 万元向其转让 4 个制剂项目的技术。 本次交易构成关联交易,不构成重大资产重组,已经公司第四届董事会 第七次临时会议审议通过,无需提交股东会审议。 过去 12 个月内,公司与前列药业发生的关联交易累计为 4 次,累计合同 金额为 130.09 万元,为日常性关联交易,交易金额在当年年度股东大会审议通 过的预计额度范围之内;公司与不同关联人未发生与本次交易类别相关的关联交 易。 本次受让的制剂品种预计市场潜力较好,但未来的具体销售情况可能受 到市场环境变化等因素影响,具有不确定性,敬请广大投资者谨慎决策,注意防 范投资风险。 一、关联交易概述 (一)本次交易的基本情况 证券代码:688799 证券简称:华纳药厂 公告编号:2025 ...
华纳药厂(688799) - 2025年第二次临时股东大会决议公告
2025-12-26 11:30
证券代码:688799 证券简称:华纳药厂 公告编号:2025-097 湖南华纳大药厂股份有限公司 2025年第二次临时股东大会决议公告 本公司董事会及全体董事保证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、准确性和完整性依法承担法律责任。 重要内容提示: 本次会议是否有被否决议案:无 一、 会议召开和出席情况 (一) 股东大会召开的时间:2025 年 12 月 26 日 (二) 股东大会召开的地点:湖南省长沙市岳麓区麓天路 28 号 C7 栋公司会议 室 (三) 出席会议的普通股股东、特别表决权股东、恢复表决权的优先股股东及 其持有表决权数量的情况: | 1、出席会议的股东和代理人人数 | 47 | | --- | --- | | 普通股股东人数 | 47 | | 2、出席会议的股东所持有的表决权数量 | 74,175,743 | | 普通股股东所持有表决权数量 | 74,175,743 | | 3、出席会议的股东所持有表决权数量占公司表决权数量的比例 | 56.4847 | | (%) | | | 普通股股东所持有表决权数量占公司表决权数量的比例(%) | 56.4847 | ...