QianJin Pharmaceutical(600479)
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千金药业(600479) - 千金药业关于子公司获得药品注册证书的公告
2025-12-12 09:15
药品批准文号:国药准字 H20256229 证券代码:600479 证券简称:千金药业 公告编号:2025-061 株洲千金药业股份有限公司 关于子公司获得药品注册证书的公告 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,株洲千金药业股份有限公司(以下简称"公司")下属子公司湖南千 金湘江药业股份有限公司(以下简称"千金湘江药业")收到国家药品监督管理 局核准签发的盐酸鲁拉西酮片的《药品注册证书》。现将相关情况公告如下: 一、药品基本信息 药品名称:盐酸鲁拉西酮片 剂型:片剂 规格:40mg(按 C28H36N4O2S·HCl 计) 注册分类:化学药品 4 类 药品上市许可持有人:湖南千金湘江药业股份有限公司 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、药品其他相关信息 盐酸鲁拉西酮片用于治疗精神分裂症,最早由 Sunovion Ph ...
千金药业:下属公司盐酸鲁拉西酮片获药品注册证书
Zheng Quan Shi Bao Wang· 2025-12-12 09:13
Core Viewpoint - Qianjin Pharmaceutical (600479) announced that its subsidiary, Qianjin Xiangjiang Pharmaceutical, received the drug registration certificate for Lurasidone Hydrochloride Tablets from the National Medical Products Administration, indicating a significant advancement in its product portfolio aimed at treating schizophrenia [1] Group 1 - The approval of Lurasidone Hydrochloride Tablets marks a key milestone for the company in expanding its therapeutic offerings [1] - This product is specifically indicated for the treatment of schizophrenia, which addresses a critical area in mental health [1]
千金药业(600479.SH):盐酸鲁拉西酮片获得药品注册证书
智通财经网· 2025-12-12 09:09
Core Viewpoint - Qianjin Pharmaceutical (600479.SH) announced that its subsidiary, Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd., received the drug registration certificate for Lurasidone Hydrochloride Tablets from the National Medical Products Administration, indicating a significant step in expanding its product portfolio in the psychiatric medication market [1] Group 1: Company Developments - The approval of Lurasidone Hydrochloride Tablets is aimed at treating schizophrenia, which broadens the therapeutic options available to patients [1] - The drug was originally developed by Sunovion Pharmaceuticals Inc. and was first launched in the United States in October 2010, with domestic import approval granted in January 2019 [1] - Other companies that have received registration for this drug in China include Jiangsu Hengrui Medicine Co., Ltd., Chengdu Kanghong Pharmaceutical Group Co., Ltd., and Zhejiang Hisun Pharmaceutical Co., Ltd. [1] Group 2: Market Insights - According to Morin Data, the domestic market sales for Lurasidone Hydrochloride Tablets are projected to be approximately 52 million yuan in the first half of 2025, indicating a growing market potential for this medication [1]
千金药业:盐酸鲁拉西酮片获得药品注册证书
Zhi Tong Cai Jing· 2025-12-12 09:05
Core Viewpoint - Qianjin Pharmaceutical (600479.SH) announced that its subsidiary, Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd., has received the drug registration certificate for Lurasidone Hydrochloride Tablets from the National Medical Products Administration, indicating a significant development in its product portfolio [1] Group 1: Product Development - The Lurasidone Hydrochloride Tablets are indicated for the treatment of schizophrenia, originally developed by Sunovion Pharmaceuticals Inc. and launched in the U.S. in October 2010 [1] - The drug was approved for importation into China in January 2019, highlighting its potential in the domestic market [1] Group 2: Market Context - Other companies that have obtained the drug registration certificate in China include Jiangsu Hengrui Medicine Co., Ltd., Chengdu Kanghong Pharmaceutical Group Co., Ltd., and Zhejiang Hisun Pharmaceutical Co., Ltd. [1] - According to data from MoSheng Pharmaceuticals, the estimated domestic market sales for Lurasidone Hydrochloride Tablets are approximately 52 million yuan in the first half of 2025, indicating a growing market opportunity [1]
千金药业:子公司获得药品注册证书
Ge Long Hui· 2025-12-12 09:05
Core Viewpoint - Qianjin Pharmaceutical (600479.SH) has received the drug registration certificate for Lurasidone Hydrochloride Tablets from the National Medical Products Administration, marking a significant milestone for the company in the psychiatric medication market [1] Group 1: Drug Approval and Market Context - The drug Lurasidone Hydrochloride Tablets is indicated for the treatment of schizophrenia and was originally developed by Sunovion Pharmaceuticals Inc., first launched in the U.S. in October 2010 and approved for import in China in January 2019 [1] - Other companies that have obtained registration for Lurasidone Hydrochloride Tablets in China include Jiangsu Hengrui Medicine Co., Ltd., Chengdu Kanghong Pharmaceutical Group Co., Ltd., and Zhejiang Hisun Pharmaceutical Co., Ltd. [1] - According to data from MoSheng Pharmaceuticals, the domestic market sales for Lurasidone Hydrochloride Tablets are projected to be approximately 52 million yuan in the first half of 2025 [1] Group 2: R&D Investment - As of the date of the announcement, Qianjin Xiangjiang Pharmaceutical has invested a total of 6.3294 million yuan in the research and development of Lurasidone Hydrochloride Tablets [1]
千金药业(600479.SH):子公司获得药品注册证书
Ge Long Hui A P P· 2025-12-12 09:02
Core Viewpoint - Qianjin Pharmaceutical (600479.SH) has received the drug registration certificate for Lurasidone Hydrochloride Tablets from the National Medical Products Administration, marking a significant milestone for the company in the psychiatric medication market [1] Company Summary - Qianjin Xiangjiang Pharmaceutical, a subsidiary of Qianjin Pharmaceutical, has been approved for Lurasidone Hydrochloride Tablets, which are used to treat schizophrenia [1] - The cumulative R&D investment by Qianjin Xiangjiang Pharmaceutical in Lurasidone Hydrochloride Tablets amounts to RMB 6.3294 million [1] Industry Summary - Lurasidone Hydrochloride Tablets were first developed by Sunovion Pharmaceuticals Inc. and launched in the U.S. in October 2010, with domestic approval for import in January 2019 [1] - Other companies that have obtained registration for Lurasidone Hydrochloride Tablets in China include Jiangsu Hengrui Medicine Co., Ltd., Chengdu Kanghong Pharmaceutical Group Co., Ltd., and Zhejiang Hisun Pharmaceutical Co., Ltd. [1] - The domestic market sales for Lurasidone Hydrochloride Tablets are projected to be approximately RMB 52 million in the first half of 2025 [1]
千金药业(600479) - 千金药业关于变更持续督导独立财务顾问主办人的公告
2025-12-12 09:00
证券代码:600479 证券简称:千金药业 公告编号:2025-062 株洲千金药业股份有限公司 关于变更持续督导独立财务顾问主办人的公告 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。 本次变更后,公司本次重组的持续督导独立财务顾问主办人为颜永彬先生和 黄艺庭先生,持续督导期至中国证券监督管理委员会和上海证券交易所规定的持 续督导义务结束为止。 特此公告。 株洲千金药业股份有限公司 2025 年 12 月 13 日 附件:黄艺庭先生简历 黄艺庭先生,保荐代表人、注册会计师,现任国投证券投资银行业务委员会 高级副总裁,曾主持或参与谷数科技 IPO、华来科技 IPO,华纳药厂向不特定对 象发行可转换债券、宁波方正及迦南科技向特定对象发行股票、广州开发区金控 集团非公开发行公司债、东华能源小公募债券等项目,具有丰富的投资银行业务 经验。 国投证券股份有限公司(以下简称"国投证券")为株洲千金药业股份有限 公司(以下简称"公司")发行股份及支付现金购买资产暨关联交易(以下简称 "本次重组")的独立财务顾问,国投证券原指定颜永彬先生、 ...
千金药业:子公司千金湘江药业获得盐酸鲁拉西酮片药品注册证书
Mei Ri Jing Ji Xin Wen· 2025-12-12 08:53
Core Viewpoint - Qianjin Pharmaceutical (600479.SH) has received the drug registration certificate for Lurasidone Hydrochloride Tablets from the National Medical Products Administration, which is used for the treatment of schizophrenia, enhancing the company's product pipeline and supporting sustainable development [1] Company Summary - Qianjin Xiangjiang Pharmaceutical, a subsidiary of Qianjin Pharmaceutical, has invested a total of 6.3294 million yuan in the research and development of Lurasidone Hydrochloride Tablets [1] - The approval of Lurasidone Hydrochloride Tablets signifies that the product has passed the consistency evaluation, which is a positive development for the company's product offerings [1] Industry Summary - Other companies that have received the drug registration certificate for Lurasidone Hydrochloride Tablets include Jiangsu Hengrui Medicine Co., Ltd., Zhengda Tianqing Pharmaceutical Group Co., Ltd., and Zhejiang Haizheng Pharmaceutical Co., Ltd. [1] - The production and sales of the drug are subject to significant uncertainties due to factors such as national policies and market environment changes [1]
千金药业:子公司盐酸鲁拉西酮片获得药品注册证书
Xin Lang Cai Jing· 2025-12-12 08:52
Core Viewpoint - Qianjin Pharmaceutical's subsidiary, Qianjin Xiangjiang Pharmaceutical, has received the drug registration certificate for Lurasidone Hydrochloride Tablets from the National Medical Products Administration, indicating a significant milestone in the company's product pipeline and potential for sustainable development [1] Group 1: Drug Registration and Development - The drug is indicated for the treatment of schizophrenia, with other companies such as Jiangsu Hengrui Medicine Co., Ltd., Zhengda Tianqing Pharmaceutical Group Co., Ltd., and Zhejiang Hisun Pharmaceutical Co., Ltd. also having obtained registration for the same drug [1] - Qianjin Xiangjiang Pharmaceutical has invested a total of 6.3294 million yuan in the research and development of Lurasidone Hydrochloride Tablets [1] Group 2: Market and Regulatory Environment - The approval of the drug registration certificate is considered equivalent to passing the consistency evaluation, which enhances the company's product offerings [1] - The production and sales of the drug are subject to significant uncertainties due to potential changes in national policies and market conditions [1]
千金药业:公司一直与包括机构股东在内的投资者保持良好交流
Zheng Quan Ri Bao· 2025-12-10 14:13
证券日报网讯 12月10日,千金药业在互动平台回答投资者提问时表示,公司一直与包括机构股东在内 的投资者保持良好交流,传递公司价值。 (文章来源:证券日报) ...