Workflow
艾司唑仑片
icon
Search documents
江苏联环药业股份有限公司关于控股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。 江苏联环药业股份有限公司(以下简称"公司")控股子公司新乡市常乐制药有限责任公司(以下简 称"常乐制药")于近日收到国家药品监督管理局核准签发的关于艾司唑仑片(以下简称"本品"或"该药 品")《药品补充申请批准通知书》,批准常乐制药本品通过仿制药质量和疗效一致性评价(以下简 称"一致性评价")。现将相关情况公告如下: 通知书编号:2025B05779 申请内容:仿制药质量和疗效一致性评价。 审批结论:经审查,本品通过仿制药质量和疗效一致性评价。 一、药品基本信息 药品名称:艾司唑仑片 剂型:片剂 注册分类:化学药品 规格:1mg 包装规格:10片/板,10板/盒;20片/瓶 原药品批准文号:国药准字H41020215 受理号:CYHB2450585 由于药品销售受到国家政策、市场环境、市场接受度、市场竞争力等因素影响,存在不确定性,敬请广 大投资者审慎决策,注意投资风险。 特此公告。 江苏联环药业股份有限公司董事会 2025年12月5日 二、药品的其他情况 艾司唑仑片主要用于抗焦 ...
联环药业:关于控股子公司药品通过仿制药一致性评价的公告
Zheng Quan Ri Bao· 2025-12-04 13:40
Core Points - The company Lianhuan Pharmaceutical announced that its subsidiary, Xinxiang Changle Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the supplemental application of Eszopiclone tablets, confirming that the product meets the consistency evaluation of quality and efficacy for generic drugs [2] Group 1 - Lianhuan Pharmaceutical's subsidiary has successfully passed the consistency evaluation for its generic drug [2] - The approval is significant for the company's product portfolio and market positioning in the pharmaceutical industry [2]
12月4日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-04 10:31
Group 1 - China Pacific Insurance has received approval from the financial regulatory authority for Wang Yuhua to serve as a director [1] - Shanghai Bank announced that the regulatory authority has approved Chen Lei's qualification as vice president [2] - Shanghai HuGong has decided to terminate the "Aerospace Equipment Manufacturing Base" fundraising project due to significant changes in project feasibility [3] Group 2 - Dongwang Times plans to reduce its stake by up to 1.20% through share sales [4] - Zhinancun intends to increase its capital by 100 million yuan in its wholly-owned subsidiary, Maigao Securities [5] - Jinxinnong reported a sales revenue of 115 million yuan from pig sales in November [6] Group 3 - Tiantan Biological has completed the Phase III clinical trial of its human prothrombin complex, showing good efficacy and safety for hemophilia B patients [7] - Beijete's subsidiary has signed a framework agreement for equity acquisition to gain control of Yunnan Wenye Nonferrous Metals [8] - Zhongsheng Pharmaceutical's RAY1225 injection has received approval for a new clinical trial indication for treating metabolic-associated fatty liver disease [9] Group 4 - Enhua Pharmaceutical's hydrochloride sulpiride tablets have passed the consistency evaluation for generic drugs [10] - Shenkong Co. plans to invest 60 million yuan in a semiconductor industry fund [11] - Lianhuan Pharmaceutical's subsidiary has received approval for its drug to pass the consistency evaluation for generic drugs [12] Group 5 - Dazhong Transportation has received approval to issue debt financing tools totaling 4.5 billion yuan [13] - Jintian Titanium Industry plans to invest 50 million yuan in an industry merger and acquisition fund [14] - Changchun Gas has committed over 1.7 billion yuan to gas facility upgrades [15] Group 6 - Laimei Pharmaceutical's innovative anti-cancer drug "Nano Carbon Iron" has received approval for clinical trials [16] - Longquan Co. has signed supply contracts worth approximately 50.76 million yuan for nuclear power components [17] - Igor plans to distribute a cash dividend of 1 yuan per 10 shares [18] Group 7 - Xingfa Group's subsidiary has signed a processing agreement for 80,000 tons of lithium iron phosphate [20] - Yunjigroup's director Wang Wanfeng has resigned for personal reasons [21] - Saiseng Pharmaceutical's application for the listing of a new drug has been accepted by the regulatory authority [22] Group 8 - Xinhua Medical has obtained registration certificates for two new medical devices [23] - Chaoying Electronics plans to invest 100 million USD in its Thai subsidiary for an AI circuit board expansion project [24] - Suzhou Planning's application to acquire 100% of Dongjin Aviation has been accepted by the Shenzhen Stock Exchange [25]
联环药业(600513.SH)子公司艾司唑仑片通过一致性评价
智通财经网· 2025-12-04 09:57
Core Viewpoint - The announcement indicates that Lianhuan Pharmaceutical's subsidiary, Changle Pharmaceutical, has received approval from the National Medical Products Administration for the supplemental application of Estazolam tablets, confirming the drug's consistency in quality and efficacy as a generic medication [1] Group 1: Company Information - Lianhuan Pharmaceutical's subsidiary, Changle Pharmaceutical, has been granted approval for Estazolam tablets, which are primarily used for treating anxiety and insomnia [1] - Estazolam is classified as a benzodiazepine sedative-hypnotic drug, commonly used in clinical settings [1] Group 2: Industry Context - The approval of Estazolam tablets aligns with the ongoing trend of generic drugs achieving consistency in quality and efficacy, which is crucial for market competitiveness [1]
联环药业(600513.SH):艾司唑仑片药品通过仿制药一致性评价
Ge Long Hui A P P· 2025-12-04 08:56
Core Viewpoint - The company, Lianhuan Pharmaceutical, announced that its subsidiary, Xinxiang Changle Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the supplemental application of Estazolam tablets, which have passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1: Company Information - Lianhuan Pharmaceutical's subsidiary, Xinxiang Changle Pharmaceutical, is now authorized to produce Estazolam tablets, a medication primarily used for anxiety and insomnia [1] - Estazolam is classified as a benzodiazepine sedative-hypnotic drug, commonly used in clinical settings [1] Group 2: Industry Context - The approval of Estazolam tablets aligns with the ongoing trend in the pharmaceutical industry towards the development and approval of generic medications that meet quality and efficacy standards [1]
联环药业:艾司唑仑片通过仿制药一致性评价
Core Viewpoint - The announcement from Lianhuan Pharmaceutical indicates that its subsidiary, Xinxiang Changle Pharmaceutical, has received approval for the generic drug Estazolam, which is used for treating anxiety and insomnia, enhancing the company's product portfolio in the central nervous system treatment area [1] Company Summary - Lianhuan Pharmaceutical's subsidiary, Xinxiang Changle Pharmaceutical, has been approved by the National Medical Products Administration for the supplemental application of Estazolam tablets [1] - The drug is primarily used for anxiety, insomnia, tension, fear, and has applications in treating epilepsy and seizures [1] - The estimated sales revenue for Estazolam in domestic sample hospitals for 2024 is approximately 364 million yuan [1] - The research and development investment for the consistency evaluation of this drug was about 4.752 million yuan (unaudited) [1] - The company has obtained six production licenses for Estazolam [1] - The approval is expected to enhance the company's market competitiveness but is not anticipated to have a significant impact on recent operating performance [1] Industry Summary - The sales of pharmaceuticals are influenced by national policies and market conditions, which introduce uncertainties [1]
联环药业:控股子公司药品艾司唑仑片通过一致性评价
人民财讯12月4日电,联环药业(600513)12月4日公告,公司控股子公司新乡市常乐制药有限责任公司 近日收到国家药监局核准签发的关于艾司唑仑片的《药品补充申请批准通知书》,批准该药品通过仿制 药质量和疗效一致性评价。艾司唑仑片主要用于抗焦虑、失眠。也用于紧张、恐惧及抗癫痫和抗惊厥。 该药品作为临床常用的苯二氮类镇静催眠药物。 ...
联环药业子公司艾司唑仑片通过一致性评价
智通财经网· 2025-12-04 08:48
Core Viewpoint - The announcement indicates that Lianhuan Pharmaceutical's subsidiary, Changle Pharmaceutical, has received approval from the National Medical Products Administration for the supplemental application of Estazolam tablets, confirming the drug's consistency in quality and efficacy as a generic medication [1] Group 1: Company Information - Lianhuan Pharmaceutical's subsidiary, Changle Pharmaceutical, has been granted approval for Estazolam tablets [1] - Estazolam is primarily used for treating anxiety and insomnia, and it also serves other purposes such as addressing tension, fear, and as an anticonvulsant [1] - The drug is classified as a commonly used benzodiazepine sedative-hypnotic medication [1]
联环药业:控股子公司药品通过仿制药一致性评价
Xin Lang Cai Jing· 2025-12-04 08:43
联环药业公告,控股子公司新乡市常乐制药有限责任公司于近日收到国家药品监督管理局核准签发的关 于艾司唑仑片《药品补充申请批准通知书》,批准常乐制药本品通过仿制药质量和疗效一致性评价。艾 司唑仑片主要用于抗焦虑、失眠。也用于紧张、恐惧及抗癫痫和抗惊厥。该药品作为临床常用的苯二氮 类镇静催眠药物。 ...