湖南华纳大药厂股份有限公司 自愿披露关于获得药品注册证书的公告 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。 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聚乙二醇钠钾散《药品注册证书》，现将相关情况公告如下： 一、药品相关信息 1、药品名称：聚乙二醇钠钾散 2、剂 型：散剂 3、规 格：本品为复方制剂，每包含聚乙二醇 3350 为 13.1250g、氯化钠 0.3507g、氯化钾 0.0466g、碳酸氢钠 0.1785g 4、申请事项：药品注册（境内生产） 5、注册分类：化学药品 4 类 证券代码：688799 证券简称：华纳药厂 公告编号：2025-080 6、受理号：CYHS2401712 7、药品批准文号：国药准字 H20255590 8、上市许可持有人：湖南华纳大药厂股份有限公司 9、审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查， 本品符合药品注册的有关要求，批准注册，发给药品注册证书。质量标准、说明 书、标签及生产工艺照所附执行。药品生产企业应当符合药品生 ...

Core Viewpoint - Warner Pharmaceuticals (688799.SH) has received approval from the National Medical Products Administration for the drug registration certificate of polyethylene glycol sodium potassium powder, which is indicated for the treatment of chronic constipation and fecal impaction [1] Group 1 - The polyethylene glycol sodium potassium powder is classified as a Category 4 chemical drug under the new registration classification [1] - The approval is considered equivalent to passing the consistency evaluation [1]

Core Viewpoint - Warner Pharmaceuticals has received a drug registration certificate from the National Medical Products Administration for polyethylene glycol sodium potassium powder, which is intended for the treatment of chronic constipation and fecal impaction [1] Company Summary - Warner Pharmaceuticals announced the receipt of a drug registration certificate for a new product [1] - The product is specifically designed to address chronic constipation and fecal impaction [1] Industry Summary - The approval of this product indicates a potential growth opportunity in the market for treatments related to gastrointestinal disorders [1]

Policy Developments - The "Regulations on the Management of Clinical Research and Clinical Translation Applications of Biomedical New Technologies" were officially published, emphasizing the balance between innovation and safety in the biomedical sector [2] - The National Healthcare Security Administration has issued a draft for "Basic Medical Insurance Registration Service Specifications," mandating that registration for individuals or units must not exceed five working days [3] Industry News - The National Healthcare Security Administration is conducting a special investigation into "dual pricing" practices at designated retail pharmacies, which discriminate between insured and uninsured patients [4] - Keren Biotechnology's TROP2 ADC has received approval for second-line treatment of EGFR mutation NSCLC, marking a significant advancement for the company's core product [6] - Beijing Norsland Biotechnology Co., Ltd. plans to issue H-shares and apply for listing on the Hong Kong Stock Exchange to enhance its international presence and raise funds for long-term development [8] - The National Medical Products Administration has reclassified Dangshen Granules and Regulating Menstrual Blood Capsules from prescription to over-the-counter drugs [10] - KingMed Diagnostics, Tencent, and Guangzhou Medical University First Affiliated Hospital announced a collaboration to develop a multimodal model for pathological genetics using AI [11] Company Updates - Kangtai Medical received a warning letter from the FDA regarding non-compliance with medical device quality system regulations, which could prevent its products from entering the U.S. market until issues are resolved [14] - Warner Pharmaceuticals has voluntarily withdrawn its drug registration application for Arolol Hydrochloride Tablets, which will not significantly impact the company's current or future operations [15]

Core Viewpoint - Hunan Warner Pharmaceutical Co., Ltd. has voluntarily withdrawn its drug registration application for Arolol Hydrochloride Tablets, which is primarily used for treating primary hypertension, angina, tachyarrhythmia, and essential tremor [1] Group 1: Company Actions - The company submitted the marketing authorization application for Arolol Hydrochloride Tablets to the National Medical Products Administration in April 2024 and received acceptance [1] - After careful consideration and alignment with its research and development strategy, the company decided to withdraw the drug registration application [1] Group 2: Impact on Operations - The voluntary withdrawal of the drug registration application will not have a significant impact on the company's current and future production operations and performance [1]

Core Points - Hunan Warner Pharmaceutical Co., Ltd. has voluntarily disclosed the withdrawal of its drug registration application for Arolol Hydrochloride Tablets [1] - The National Medical Products Administration has approved the termination of the drug registration application [1] - The drug is primarily used for treating primary hypertension (mild to moderate), angina pectoris, tachycardia, and essential tremor [1] Summary by Sections - **Drug Registration Application** - The company submitted the application for Arolol Hydrochloride Tablets in April 2024 and received acceptance [1] - After careful consideration and alignment with its R&D strategy, the company decided to withdraw the application [1] - **Impact on Business** - The withdrawal of the drug registration application will not have a significant impact on the company's current or future operations and performance [1]

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。 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》，同意公司撤回盐酸阿罗洛尔 片的注册申请。现将相关情况公告如下： 证券代码：688799 证券简称：华纳药厂 公告编号：2025-079 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 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 10 月 13 日 | 药品名称 | 注册分类 | 受理号 | 通知书编号 | 审批结论 | | --- | --- | --- | --- | --- | | | | | | 根据《药品注册管理办法》第八十九条以 | | 盐酸阿罗 | 化学药品 | CYHS2401127 | 2025L00304 | 及申请人提交的撤回申请《关于申请撤回 | | 洛尔片 | 4 类 | | | 盐酸阿罗洛尔片上市许可 ...

Core Viewpoint - Warner Pharmaceuticals (688799.SH) has received approval from the National Medical Products Administration to withdraw its drug registration application for Arolol Hydrochloride Tablets [1] Group 1 - The drug Arolol Hydrochloride Tablets is primarily used for the treatment of essential hypertension (mild to moderate), angina pectoris, tachyarrhythmia, and essential tremor [1]

Core Viewpoint - Hunan Warner Pharmaceutical Co., Ltd. has received a notice from the National Medical Products Administration regarding the termination of its drug registration application for Arolol Hydrochloride Tablets, which are primarily used for treating primary hypertension [1] Group 1 - The drug in question is classified as a Class 4 chemical drug with the acceptance number CYHS2401127 [1] - The company submitted the marketing authorization application in 2024 but has decided to withdraw it after careful consideration and alignment with its research and development strategy [1]

本报讯 （记者何文英）近日，中国医药包装协会发布了团体标准《药品包装盒纸板选择指南》（以下 简称《指南》）（T/CNPPA 3029-2025）。 湖南华纳大药厂股份有限公司（以下简称"华纳药厂"）与华润双鹤药业股份有限公司、齐鲁制药有限公 司等国内药品生产头部企业，共同参与编写、制定了这项团体标准，为药品包装提供规范化"模板"。 在保护性和功能性两个方面，《指南》中提到对纸板的理化性能如横向耐折度、内结合强度、折痕挺度 等指标，明确详细的量化参数。同时，还就纸板的选择，制定了一套规范化流程图。 《指南》起草人之一、华纳药厂员工徐先知介绍，该《指南》的起草历时5年，数易其稿，从多个细化 指标，既强调美观实用，又能适应现代化和自动化的药品包装生产线，且能很好地保护药品；更强调不 能发生有害物质的迁移，不能对药品产生不良影响。 "《指南》为药品包装的选择提供了明确要求和标准化流程，也为药品包装类产品研发、生产制造、质 量管控及产品应用提供权威评判依据。"徐先知表示，通过参与制定这个指南，华纳药厂也为推动药品 包装标准化升级、促进药品包装行业科学健康发展贡献了自己的力量。 （编辑 张文玲 郭之宸） 药品是涉及人类安 ...