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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
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-10-14 05:35
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 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 当符合药品生产质量管理规范要求方可生产销售。 二、药品的相关情况 聚乙二醇钠钾散适用于治疗慢性便秘、粪便嵌塞。公司聚乙二醇钠钾散按新注册分类化学药品4类获得 药品注册证 ...
华纳药厂:自愿披露关于获得药品注册证书的公告
Zheng Quan Ri Bao· 2025-10-13 14:09
(文章来源:证券日报) 证券日报网讯 10月13日晚间,华纳药厂发布公告称,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》。 ...
多家医药上市公司相关产品获得药品注册证书
Zheng Quan Shi Bao Wang· 2025-10-13 11:20
Group 1 - Warner Pharmaceuticals received the drug registration certificate for polyethylene glycol sodium potassium powder, which is indicated for the treatment of chronic constipation and fecal impaction [1] - The approval of the drug registration certificate enriches the company's formulation product variety and positively impacts the optimization of the product structure [1] - Warner Pharmaceuticals reported a revenue of 714 million yuan for the first half of 2025, a year-on-year decrease of 3.37%, with a net profit attributable to shareholders of 71 million yuan, down 36.95% [1] Group 2 - Renfu Pharmaceutical announced that its subsidiary, Wuhan Jiulong Renfu Pharmaceutical Co., received the drug registration certificate for dapoxetine hydrochloride tablets, which are used to treat premature ejaculation [2] - The total sales of dapoxetine hydrochloride tablets in 2024 are estimated to be around 1.1 billion yuan, with major manufacturers including Shandong Huabo Kaisheng Biotechnology Co. and Sichuan Kelun Pharmaceutical Co. [2] - Anglikon received the drug registration certificate for azilsartan potassium tablets, which are indicated for the treatment of primary hypertension in adults [3] - Xinhua Pharmaceutical announced the approval of fumarate bisoprolol tablets, indicated for hypertension and chronic stable heart failure with reduced left ventricular function [3]
10月13日晚间重要公告一览
Xi Niu Cai Jing· 2025-10-13 10:13
Group 1 - Harbin Air Conditioning plans to transfer 40% equity of its subsidiary, Harbin Fushanchuan Biotechnology Development Co., Ltd. The subsidiary reported a net profit of -16.0963 million yuan for 2024, which is 218.83% of the previous year's net profit absolute value [1] - Xinhua Insurance expects a net profit of 29.986 billion to 34.122 billion yuan for the first three quarters of 2025, representing a year-on-year growth of 45% to 65% [1][2] - Gansu Energy anticipates a net profit of 1.55 billion to 1.6 billion yuan for the first three quarters of 2025, reflecting a year-on-year increase of 11.86% to 15.47% [2][3] Group 2 - Dongfang Tower forecasts a net profit of 750 million to 900 million yuan for the first three quarters of 2025, indicating a year-on-year growth of 60.83% to 93% [4] - Meili Eco announced that its subsidiary won a bid for an EPC project worth 2.375 billion yuan [6] - Bohai Chemical's wholly-owned subsidiary will undergo routine maintenance for its 600,000 tons/year PDH unit, expected to last about 30 days [8] Group 3 - Qin Port Co. reported a total throughput of 317.02 million tons for the first nine months of 2025, a year-on-year increase of 5.56% [10] - Jianglong Shipbuilding won a bid for a 72.99 million yuan fishery enforcement vessel project, accounting for 4.22% of its 2024 audited revenue [11] - Longyuan Technology expects a net profit of 35 million to 40 million yuan for the first three quarters of 2025, representing a year-on-year increase of 50.11% to 71.55% [12] Group 4 - Naipu Mining anticipates a net profit of 61 million to 66 million yuan for the first three quarters of 2025, reflecting a year-on-year decline of 45.16% to 49.32% [14] - Jinggong Steel Structure reported a cumulative contract amount of 17.98 billion yuan for the first nine months of 2025, a year-on-year increase of 4.8% [15][16] - Shenzhen Gas reported a net profit of 918 million yuan for the first three quarters of 2025, a year-on-year decrease of 13.08% [17] Group 5 - Yabao Pharmaceutical's subsidiary received a drug registration certificate for a new diabetes medication [18] - Shaanxi Coal's coal production in September was 14.56 million tons, a year-on-year increase of 5.34% [20] - Sifang New Materials reported a 15.94% year-on-year decline in concrete production for the first three quarters [22] Group 6 - Nanjing Foods reported a consolidated revenue of 276 million yuan in September, a slight increase of 0.0016% year-on-year [23] - Pulaike received a new veterinary drug registration certificate for a flea and tick treatment [24] - Zhucheng Technology received a cash dividend of 15 million yuan from its subsidiary [25] Group 7 - David Medical's subsidiary received a medical device registration certificate for a portable electronic endoscope image processor [26] - Zhongtong Bus reported a 36.88% year-on-year increase in sales in September, totaling 1,106 units [27] - Xiantan Co. reported a 11.95% year-on-year increase in chicken sales revenue in September [28] Group 8 - Bojun Technology expects a net profit of 552 million to 662 million yuan for the first three quarters of 2025, a year-on-year increase of 50% to 80% [30] - Haishi Pharmaceutical's innovative pain relief drug clinical trial application has been accepted [31] - Lingxiao Pump Industry used 80 million yuan of idle funds to purchase financial products [32] Group 9 - Qiangda Circuit's subsidiary completed business registration changes to expand its operational scope [33] - *ST Tianyu's controlling shareholder applied for bankruptcy liquidation due to severe financial difficulties [34] - Baolidi's shareholder plans to reduce holdings by up to 1 million shares [36] Group 10 - Zijin Mining completed the acquisition of Kazakhstan's Raygorodok gold mine, controlling 100% of its rights [44] - Zhonggang Luoyang's indirect controlling shareholder completed a capital increase, raising registered capital from approximately 26.666 billion yuan to 44.824 billion yuan [46] - Jinyu Jidong's director resigned due to work adjustments [47]
华纳药厂:“聚乙二醇钠钾散”取得注册证
Mei Ri Jing Ji Xin Wen· 2025-10-13 09:19
每经AI快讯,华纳药厂(SH 688799,收盘价:60.69元)10月13日晚间发布公告称,近日,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》。产品名称为"聚乙二醇钠钾散"。 2024年1至12月份,华纳药厂的营业收入构成为:医药制造占比99.01%,其他业务占比0.99%。 (记者 胡玲) 截至发稿,华纳药厂市值为80亿元。 每经头条(nbdtoutiao)——AI技术滥用调查:明星可被"一键换装","擦边"内容成流量密码,技术防 线为何形同虚设? ...
华纳药厂(688799) - 自愿披露关于获得药品注册证书的公告
2025-10-13 09:15
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 ...
华纳药厂(688799.SH):聚乙二醇钠钾散获得药品注册证书
Ge Long Hui A P P· 2025-10-13 09:09
格隆汇10月13日丨华纳药厂(688799.SH)公布,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》,聚乙二醇钠钾散适用于治疗慢性便秘、粪便嵌塞。公司聚乙二醇钠钾散按新注册 分类化学药品4类获得药品注册证书,视同通过一致性评价。 ...
华纳药厂:聚乙二醇钠钾散获得药品注册证书
2 1 Shi Ji Jing Ji Bao Dao· 2025-10-13 09:00
南财智讯10月13日电,华纳药厂公告,公司收到国家药品监督管理局签发的聚乙二醇钠钾散《药品注册 证书》。该产品用于治疗慢性便秘、粪便嵌塞。 ...
医保局严查定点药店“阴阳价”;康泰医学收到美国FDA警告信
2 1 Shi Ji Jing Ji Bao Dao· 2025-10-13 01:03
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]
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
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-10-12 23:21
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]