NKF(603707)
Search documents
健友股份:子公司产品注射用达巴万星获得美国FDA批准
Xin Lang Cai Jing· 2025-11-27 08:22
Core Viewpoint - The company announced that its subsidiary, Jianjin Pharmaceutical Co., Ltd., received ANDA approval from the FDA for injectable Dalbavancin, which is expected to positively impact the company's financial performance [1] Group 1: Regulatory Approval - Jianjin Pharmaceutical received ANDA approval for injectable Dalbavancin, 500 mg/vial, on November 27, 2025 [1] - The reference formulation for injectable Dalbavancin is held by AbbVie Inc., which was approved by the FDA on May 23, 2014, under the brand name DALVANCE [1] Group 2: Market Competition - Currently, there are two other companies, Teva Pharmaceuticals Inc. and Fresenius Kabi USA LLC, that have also received approval for injectable Dalbavancin generics in the U.S. [1] Group 3: Investment and Financial Impact - The company has invested approximately RMB 18.53 million in research and development for this project [1] - The newly approved product is expected to be launched in the U.S. soon, which is anticipated to have a positive effect on the company's operating performance [1]
健友股份:没有用于流感治疗的药物或在研药物
Ge Long Hui· 2025-11-25 09:11
Group 1 - The company, Jianyou Co., Ltd. (603707.SH), stated on the investor interaction platform that it does not have any drugs for the treatment of influenza or any drugs under research for this purpose [1]
健友股份(603707.SH):没有用于流感治疗的药物或在研药物
Ge Long Hui· 2025-11-25 07:41
Group 1 - The company, Jianyou Co., Ltd. (603707.SH), stated on the investor interaction platform that it does not have any drugs for the treatment of influenza or any drugs under research for this purpose [1]
健友股份(603707.SH):公司没有用于流感治疗的药物或在研药物
Ge Long Hui· 2025-11-25 07:41
Group 1 - The company, Jianyou Co., Ltd. (603707.SH), stated on the investor interaction platform that it does not have any drugs for the treatment of influenza or any drugs under research for this purpose [1]
健友股份:截至10月31日股东人数38029户
Zheng Quan Ri Bao· 2025-11-20 11:13
证券日报网讯健友股份11月20日在互动平台回答投资者提问时表示,截至2025年10月31日,公司股东人 数为38029户。 (文章来源:证券日报) ...
健友股份:目前公司拥有12条通过美国FDA批准的生产线
Mei Ri Jing Ji Xin Wen· 2025-11-18 10:23
Core Viewpoint - The company, GY Pharmaceutical (603707.SH), addresses investor concerns regarding its R&D capabilities, sales focus, and production base advantages, highlighting its strengths in these areas. Group 1: R&D Capabilities - The company currently employs over 500 R&D personnel, including renowned Chinese FDA quality experts, aseptic injection experts, and biological research and management experts, forming one of the best expert teams in China [1] - The company emphasizes its commitment to drug research and development, countering concerns about the lack of R&D background among its executives [1] Group 2: Sales Strategy - The company is a comprehensive pharmaceutical enterprise that integrates drug R&D, production, and sales, with a strong focus on pharmaceutical sales [1] - The company is actively expanding its overseas sales market, indicating a strategic move to enhance its market presence beyond domestic sales [1] Group 3: Production Base and Advantages - The company's production bases are primarily located in Nanjing and Chengdu, with a total of 12 production lines approved by the US FDA (9 in Nanjing and 3 in Chengdu) [1] - The production facilities utilize reliable, advanced, and highly automated equipment, which provides significant advantages in production efficiency, stability, and resource consumption while ensuring high-quality production [1]
健友股份:关于子公司获得美国FDA醋酸奥曲肽注射液药品增加生产场地注册批件的公告
Zheng Quan Ri Bao· 2025-11-12 13:17
Core Viewpoint - Jianyou Co., Ltd. announced that its subsidiary, Meitheal Pharmaceuticals, Inc., received approval from the U.S. FDA for the production of Acetate Octreotide Injection in multiple concentrations [2] Group 1: Company Developments - Meitheal Pharmaceuticals, Inc. has been granted an approval letter by the U.S. FDA for the production of Acetate Octreotide Injection at concentrations of 50 mcg/mL, 100 mcg/mL, and 500 mcg/mL [2] - The approval allows production to take place at the facilities of Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. [2]
健友股份(603707) - 健友股份关于子公司获得美国FDA醋酸奥曲肽注射液药品增加生产场地注册批件的公告
2025-11-12 09:46
| 证券代码:603707 | 证券简称:健友股份 | 公告编号:2025-086 | | --- | --- | --- | | 债券代码:113579 | 债券简称:健友转债 | | 南京健友生化制药股份有限公司 (六)申 请 人:Meitheal Pharmaceuticals Inc. 二、药品其他相关情况 关于子公司获得美国FDA醋酸奥曲肽注射液 药品增加生产场地注册批件的公告 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个别及连带责任。 南京健友生化制药股份有限公司(以下简称"健友股份"或"公司")子公司 Meitheal Pharmaceuticals, Inc.(以下简称"Meitheal")于近日收到美国食品药品 监督管理局(以下简称"美国 FDA")签发的醋酸奥曲肽注射液,50 mcg/mL, 100 mcg/mL, 和 500 mcg/mL(ANDA 号:075957)增加生产场地的批准信,批准在 南京健友生化制药股份有限公司场地生产,现将相关情况公告如下: 一、药品的基本情况 (一)药品名称:醋酸奥曲肽注射液 ...
健友股份(603707) - 健友股份关于选举第五届董事会职工代表董事的公告
2025-11-12 09:46
特此公告。 南京健友生化制药股份有限公司董事会 南京健友生化制药股份有限公司 关于选举第五届董事会职工代表董事的公告 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个别及连带责任。 南京健友生化制药股份有限公司(以下简称"公司")于 2025 年 11 月 12 日召开 2025 年第一次临时股东大会,审议通过了《关于变更注册资本、取消监 事会并修订公司章程的议案》,根据修订后的《公司章程》,公司董事会成员中 应当包括 1 名职工代表董事,由公司职工通过职工代表大会民主选举产生。 根据《公司法》《上市公司章程指引》《上海证券交易所股票上市规则》等 法律法规和规范性文件以及《公司章程》的相关规定,公司于 2025 年 11 月 12 日召开了职工代表大会,经全体与会职工代表表决,选举黄锡伟先生为公司第五 届董事会职工代表董事(简历详见附件),黄锡伟先生原为第五届董事会非职工 董事(同时为第五届董事会战略委员会成员),本次选举完成后,黄锡伟先生变 更为职工代表董事,公司第五届董事会成员及各专门委员会成员不变。黄锡伟先 生任期自本次职工代表大 ...
健友股份(603707) - 江苏世纪同仁律师事务所关于南京健友生化制药股份有限公司2025年第一次临时股东大会的法律意见书
2025-11-12 09:45
本律师同意将本法律意见书随贵公司本次股东大会决议一并公告,并依法 对本法律意见书承担相应的责任。 本律师根据相关法律、法规和规范性文件的要求,按照律师行业公认的业 务标准、道德规范和勤勉尽责精神,出具法律意见如下: 一、关于本次股东大会的召集、召开程序和召集人资格 1.本次股东大会由董事会召集。2025年10月24日,贵公司召开第五届董 事会第十五次会议,决定于 2025年11月 12日召开 2025年第一次临时股东大 会。2025年10月25日,贵公司在《中国证券报》《上海证券报》及上海证券 交易所网站(www.sse.com.cn)上刊登了该次董事会决议和《关于召开 2025 年 第一次临时股东大会的通知》(以下简称"会议通知")。 江苏世纪同仁律师事务所关于 南京健友生化制药股份有限公司2025年第一次临时股东大会的 法律意见书 致:南京健友生化制药股份有限公司 根据《中华人民共和国公司法》《中华人民共和国证券法》和中国证监会 《上市公司股东会规则》等法律、法规和规范性文件以及贵公司《章程》的规 定,本所受贵公司董事会的委托,指派本律师出席贵公司 2025年第一次临时股 东大会,并就本次股东大会的召集、 ...