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]

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]

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].

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].

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]

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 ...

Core Viewpoint - The company, Jianyou Co., Ltd. (603707.SH), has received approval from the National Medical Products Administration (NMPA) for its sodium heparin injection products, indicating a successful completion of the consistency evaluation for generic drug quality and efficacy [1] Group 1: Product Approval - The NMPA has issued a notification for the approval of sodium heparin injection in two dosages: 0.3ml with 3075AⅩaIU and 0.6ml with 6150AⅩaIU [1] - The approved product is intended for use in surgical procedures to prevent venous thromboembolism in patients at moderate to high risk of venous thrombus formation [1] Group 2: Clinical Applications - Sodium heparin injection is used for the treatment of established deep vein thrombosis and in combination with aspirin for unstable angina and non-Q-wave myocardial infarction during the acute phase [1] - The product is also utilized in hemodialysis to prevent clot formation during extracorporeal circulation [1]

Core Viewpoint - The company, Jianyou Co., Ltd. (603707.SH), has received approval from the NMPA for its product, Enoxaparin Sodium Injection in 0.3ml and 0.6ml specifications, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approved product, Enoxaparin Sodium Injection, is used for the prevention of venous thromboembolism in surgical procedures and for the treatment of established deep vein thrombosis [1]

Core Viewpoint - The company, Jianyou Co., Ltd. (603707.SH), has received approval from the National Medical Products Administration (NMPA) for its product, Nadroparin Calcium Injection, indicating a successful completion of the consistency evaluation for generic drug quality and efficacy [1] Group 1: Product Approval - The NMPA has issued a supplemental application approval notice for Nadroparin Calcium Injection in two dosages: 0.3ml (3075AⅩaIU) and 0.6ml (6150AⅩaIU) [1] - The product is approved for use in preventing venous thromboembolism in patients at moderate to high risk during surgical procedures [1] - It is also indicated for the treatment of established deep vein thrombosis and in combination with aspirin for unstable angina and non-Q wave myocardial infarction in the acute phase [1] Group 2: Clinical Applications - Nadroparin Calcium Injection is utilized in hemodialysis to prevent clot formation during extracorporeal circulation [1]

Group 1 - The restructuring protein concept declined by 1.06%, ranking among the top declines in concept sectors, with *ST WanFang hitting the limit down [1] - Within the restructuring protein sector, major declines were seen in He Yuan Bio, San Sheng Guo Jian, and Hua Xi Bio, while 15 stocks experienced price increases, with InnoTech, Dezheng Health, and Ao Pu Mai leading the gains at 1.72%, 1.36%, and 1.33% respectively [1][2] Group 2 - The restructuring protein sector saw a net outflow of 542 million yuan from main funds, with 33 stocks experiencing outflows, and 13 stocks seeing outflows exceeding 10 million yuan [2] - He Yuan Bio had the highest net outflow of 277 million yuan, followed by Rejing Bio, Hua Xi Bio, and Hua Lan Bio with net outflows of 38.27 million yuan, 34.39 million yuan, and 32.92 million yuan respectively [2][3] Group 3 - The top stocks with net inflows in the restructuring protein sector included Jianyou Co., Xilong Science, and Borui Pharmaceutical, with net inflows of 17.18 million yuan, 13.67 million yuan, and 8.93 million yuan respectively [4]