健友股份
Search documents
健友股份:关于子公司获得美国FDA注射用维库溴铵药品增加生产场地注册批件的公告
Zheng Quan Ri Bao· 2025-11-10 13:40
Group 1 - The core point of the article is that Jianyou Co., Ltd. announced that its subsidiary, Meitheal Pharmaceuticals, Inc., received approval from the U.S. FDA to increase production sites for injectable Vecuronium Bromide, 10mg/vial and 20mg/vial [2][3] - The approval allows production at the Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. facility [2]
11月10日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-10 12:00
Group 1 - Digital Zhengtong's subsidiary Baoding Jindi won a bid for a smart water project in Jinan, with a total contract value of 109 million yuan, of which Baoding Jindi's share is approximately 77 million yuan [1] - Lingzhi Software plans to acquire 100% equity of Kaimiride through a combination of cash and stock issuance, with the final transaction price yet to be determined [1] - Tianjin Port's subsidiary plans to transfer 60% equity of China Railway Storage and Transportation, with an estimated value of 37.54 million yuan for the entire equity [2] Group 2 - New Wufeng reported a 56.97% year-on-year increase in pig sales in October, selling 610,000 pigs [3] - New Peng Co. announced a joint investment of approximately 15 million USD with Jabil to build a battery storage box project in Thailand [4] - Maiwei Bio received approval for a clinical trial of its 9MW3811 injection for pathological scars [6] Group 3 - Jiangsu Sopo completed maintenance and resumed production of its methanol and acetic acid facilities [8] - Luoniushan reported a 24.65% year-on-year increase in pig sales revenue in October, totaling 116 million yuan [9][10] - Zhongbei Communication signed a 1 billion yuan comprehensive computing service framework agreement with Xiamen Hongxin Electronics [11] Group 4 - Huayang New Materials announced the resignation of its general manager, Wu Yuehua [12] - Zhongxin Co. used 50 million yuan of idle funds to purchase structured deposits with expected annual returns between 0.55% and 2.05% [14] - Huajian Group's subsidiary signed a construction engineering design contract worth 96.54 million yuan [16] Group 5 - Jianyou Co. received FDA approval for a new production site for its injectable drug [17] - Beilu Pharmaceutical obtained a drug registration certificate for its iodine mepivacaine injection, which is included in the national medical insurance catalog [19] - *ST Yuancheng's stock will be suspended due to falling below the market cap threshold for delisting [20] Group 6 - Xiantan Co. reported a 9.3% year-on-year increase in chicken product sales revenue in October, totaling 503 million yuan [21] - Huanxu Electronics reported an 8.93% year-on-year decrease in consolidated revenue for October, amounting to 5.598 billion yuan [23] - Yisheng Co. reported a 22.97% year-on-year decrease in white feather chicken seed sales revenue in October [25] Group 7 - Yuandong Bio initiated a Phase I/II clinical trial for its ADC drug YLSH003 targeting advanced solid tumors [25] - Xiaoming Co. reported a 34.89% year-on-year decrease in chicken product sales revenue in October [26] - Nanjiao Food reported a 5.27% year-on-year decrease in consolidated revenue for October, totaling 235 million yuan [28] Group 8 - Chuangye Huikang announced a potential change in control, leading to a temporary stock suspension [30] - Tangrenshen reported a 17.91% year-on-year decrease in pig sales revenue in October, totaling 828 million yuan [32][33] - Wancheng Group plans to distribute a cash dividend of 1.5 yuan per 10 shares to shareholders [34] Group 9 - Kangguan Technology plans to distribute a cash dividend of 3.6 yuan per 10 shares to shareholders [36] - Shoudu Online's executive plans to reduce holdings of up to 19,400 shares [38] - Maolai Optical received approval for the issuance of convertible bonds [40] Group 10 - Jinkai New Energy plans to distribute a cash dividend of 0.1 yuan per share to shareholders [41] - Tianchen Medical raised the upper limit for share repurchase to 70 yuan per share [42] - Tianmu Lake used 38 million yuan of idle funds to purchase structured deposits [43]
健友股份(603707) - 健友股份关于子公司获得美国FDA注射用维库溴铵药品增加生产场地注册批件的公告
2025-11-10 08:15
关于子公司获得美国FDA注射用维库溴铵 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")签发的注射用维库溴铵,10 mg/瓶、20 mg/ 瓶(ANDA 号:074688)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 | 证券代码:603707 | 证券简称:健友股份 | 公告编号:2025-083 | | --- | --- | --- | | 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 年 01 月 03 日经 FDA 批准在美国上市。NDA 申请号为 N018776 ,现已退市。 注射用维库溴铵(ANDA 号:074688),10 mg/瓶、20 mg/瓶, ...
健友股份(603707.SH)子公司获得美国FDA注射用维库溴铵药品增加生产场地注册批件
智通财经网· 2025-11-10 08:13
Core Viewpoint - Meitheal Pharmaceuticals, Inc., a subsidiary of Jianyou Co., has received approval from the U.S. FDA to increase production facilities for injectable Vecuronium Bromide, 10mg/vial and 20mg/vial, at its Nanjing facility [1] Group 1 - The approval pertains to ANDA number 074688, allowing for expanded production capabilities [1]
健友股份(603707.SH):子公司获得美国FDA注射用维库溴铵药品增加生产场地注册批件
Ge Long Hui A P P· 2025-11-10 08:12
Core Viewpoint - The company, Jianyou Co., Ltd. (健友股份), announced that its subsidiary, Meitheal Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) to increase production capacity for injectable vecuronium bromide, with dosages of 10 mg/vial and 20 mg/vial [1] Group 1 - The FDA approval pertains to the production of vecuronium bromide, which is used as an adjunct to general anesthesia to facilitate tracheal intubation and provide skeletal muscle relaxation during surgery or mechanical ventilation [1] - The production will take place at the Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. facility [1]
健友股份(603707.SH):三期临床预估于明年第一季度开始
Ge Long Hui· 2025-11-07 10:12
Core Viewpoint - The company Jianyou Co., Ltd. (603707.SH) has announced that the Phase II clinical trial of the XTMAB project has concluded successfully, with plans to initiate Phase III clinical trials in the first quarter of next year [1] Group 1 - The Phase II clinical trial results for the XTMAB project are reported to be positive [1] - The anticipated start date for the Phase III clinical trial is projected for the first quarter of next year [1]
健友股份:XTMAB项目临床二期已经结束,三期临床预估于明年第一季度开始
Mei Ri Jing Ji Xin Wen· 2025-11-07 09:59
Core Viewpoint - The company has successfully completed the Phase II clinical trial for the new drug XTMAB targeting lung nodules, with positive results reported. The Phase III clinical trial is expected to commence in the first quarter of next year [1]. Group 1 - The Phase II clinical trial for XTMAB has concluded with favorable outcomes [1]. - The anticipated start date for the Phase III clinical trial is projected for the first quarter of next year [1].
南京健友生化制药股份有限公司关于那屈肝素钙注射液通过仿制药质量和疗效一致性评价的公告
Shang Hai Zheng Quan Bao· 2025-11-06 19:10
Core Viewpoint - Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for its enoxaparin sodium injection to pass the consistency evaluation of generic drug quality and efficacy [1][2]. Drug Basic Information - Drug Name: Enoxaparin Sodium Injection - Indications: Used in surgical procedures to prevent venous thromboembolism in moderate to high-risk situations, treat existing deep vein thrombosis, and in combination with aspirin for unstable angina and non-Q wave myocardial infarction. It is also used to prevent clot formation during hemodialysis [1][2]. - Dosage Forms: Injection (pre-filled syringe products) [2]. - Specifications: 0.3ml: 3075AXaIU and 0.6ml: 6150AXaIU [2]. - Original Drug Approval Numbers: National Drug Approval Number H20194077 and H20191005 [2]. Other Relevant Information - The company has invested approximately RMB 23.56 million in research and development for the consistency evaluation of the enoxaparin sodium injection [3]. - Currently, there are eight companies, including Jianyou, that have launched generic versions of enoxaparin sodium injection in China [3]. Impact on the Company - The approval of the consistency evaluation will provide greater support for the drug in terms of medical insurance payments and procurement by medical institutions. It also qualifies the product for participation in national drug centralized procurement [4]. - The successful evaluation is expected to enhance the market sales and competitiveness of the enoxaparin sodium injection [5].
健友股份:关于那屈肝素钙注射液通过仿制药质量和疗效一致性评价的公告
Zheng Quan Ri Bao· 2025-11-06 14:10
Group 1 - The core point of the article is that Jianyou Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for its heparin calcium injection products, indicating a successful outcome in the consistency evaluation of generic drug quality and efficacy [2][2][2] Group 2 - The approved products include heparin calcium injection in two dosages: 0.3ml with a potency of 3075 AXaIU and 0.6ml with a potency of 6150 AXaIU, with respective drug approval numbers [2][2][2]
健友股份(603707) - 健友股份关于那屈肝素钙注射液通过仿制药质量和疗效一致性评价的公告
2025-11-06 08:45
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")于近日收 到国家药品监督管理局(以下简称"NMPA")签发的那屈肝素钙注射液 0.3ml: 3075AⅩaIU(药品批准文号:国药准字 H20194077)和 0.6ml:6150AⅩaIU(药 品批准文号:国药准字 H20191005)药品补充申请批准通知书,该产品获批通过 仿制药质量和疗效一致性评价。现将相关情况公告如下: 一、药品的基本情况 (一)药品名称:那屈肝素钙注射液 (二)适应症: | 证券代码:603707 | 证券简称:健友股份 | 公告编号:2025-082 | | --- | --- | --- | | 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 关于那屈肝素钙注射液通过 仿制药质量和疗效一致性评价的公告 公司于近日收到 NMPA 的通知,公司向国家药品监督管理局药品审评中心 (CDE)申报的补充申请那屈肝素钙注射液,0.3ml:3075AⅩaIU ...