那屈肝素钙注射液
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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:那屈肝素钙注射液通过一致性评价
Zhi Tong Cai Jing· 2025-11-06 08:29
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]
健友股份:那屈肝素钙注射液通过仿制药质量和疗效一致性评价
Mei Ri Jing Ji Xin Wen· 2025-11-06 08:29
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]
健友股份(603707.SH):那屈肝素钙注射液通过一致性评价
智通财经网· 2025-11-06 08:27
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]
2025年中国低分子量肝素行业发展现状生产商销售金额、销售额、销售价格及行业技术发展趋势研判:临床应用范围日益广泛,市场需求明显增加[图]
Chan Ye Xin Xi Wang· 2025-11-03 01:27
Core Viewpoint - The low molecular weight heparin (LMWH) market in China is experiencing steady growth, driven by advancements in medical technology and increasing clinical applications, with a projected market size of approximately 68.07 billion yuan in 2024 and 69.29 billion yuan in 2025 [1][5]. Group 1: Market Size and Structure - The LMWH market in China is expected to reach 68.07 billion yuan in 2024, with the following market share distribution: dalteparin sodium injection (15.47%), low molecular weight heparin calcium injection (7.01%), nadroparin calcium injection (18.22%), enoxaparin sodium injection (26.77%), and other LMWH preparations (32.54%) [1][5]. - By 2025, the market size is projected to be around 69.29 billion yuan, with similar distribution trends among the various LMWH products [1][5]. Group 2: Industry Development and Trends - The LMWH industry has evolved significantly since the discovery of heparin in the early 20th century, with key milestones including the commercialization of heparin in 1938 and the introduction of nadroparin in 1978 [3]. - The Chinese LMWH industry has undergone three stages: crude product export, industrial enhancement, and the establishment of a complete industrial chain [3]. - The global LMWH market is also growing, with a projected increase from 4.334 billion USD in 2020 to 5.876 billion USD in 2024, and an expected market size of 6.2 billion USD in 2025 [4]. Group 3: Production and Demand - The production of LMWH in China is on the rise, with an estimated output of 36,327 million doses in 2024, up from 17,367 million doses in 2020, and expected to exceed 40,000 million doses in 2025 [6][7]. - The demand for LMWH in China is projected to reach approximately 42,523 million doses by 2025, reflecting a growing need for these anticoagulants in clinical settings [5][6]. Group 4: Competitive Landscape - Major companies in the Chinese LMWH market include Jiuyuan Gene, Hongri Pharmaceutical, Chenxin Pharmaceutical, and others, with a concentration of production in eastern coastal regions such as Jiangsu, Shandong, and Guangdong [8]. - In 2024, the market share of imported LMWH products remains above 20%, with notable sales figures for domestic products, including 3.42 billion yuan for Sanofi's enoxaparin sodium injection and 4.12 billion yuan for Qilu Pharmaceutical's LMWH sodium injection [8][9]. Group 5: Technological Advancements - The production technology for LMWH has advanced significantly, moving from traditional chemical degradation methods to modern biotechnological approaches, enhancing product purity and reducing production costs [9][10]. - Future trends in the LMWH industry include a focus on high-efficiency, green, and intelligent production methods, as well as the development of customized LMWH products in response to the rise of personalized medicine [11][12].
东诚药业(002675):18F-FDG同比较好增长 创新核药管线不断推进
Xin Lang Cai Jing· 2025-08-21 10:36
Core Insights - The company reported a decline in revenue and net profit for the first half of 2025, with total revenue at 1.384 billion yuan, down 2.6% year-on-year, and net profit attributable to shareholders at 89 million yuan, down 20.7% [1] Financial Performance - Revenue for the nuclear medicine segment reached 503 million yuan, a year-on-year increase of 0.78%, with a gross margin of 67.27% [2] - The core product, 18F-FDG, generated revenue of 212 million yuan, reflecting an 8.72% increase year-on-year [2] - The raw material drug segment reported revenue of 611 million yuan, down 7.02%, primarily due to a decline in heparin sodium sales prices [2] Development Trends - The company has invested in 7 operational nuclear pharmacies focused on single-photon drugs and 22 on positron emission drugs, with 31 nuclear drug production centers currently in operation [2] - The company’s innovative nuclear drug pipeline is progressing, with the approval of sodium fluoride [18F] injection in May 2025 and ongoing clinical trials for several other products [3] Profit Forecast and Valuation - The company maintains its EPS forecast for 2025 and 2026 at 0.32 yuan and 0.40 yuan, respectively, with the current stock price corresponding to a P/E ratio of 55.1 times for 2025 and 43.9 times for 2026 [4] - The target price has been raised by 16.4% to 19.2 yuan, indicating an 8.8% upside potential from the current stock price [4]
东诚药业(002675) - 002675东诚药业投资者关系管理信息20250818
2025-08-18 01:10
Group 1: Financial Performance - The company achieved a revenue of 1.384 billion CNY, a year-on-year decrease of 2.60% [1] - The net profit attributable to shareholders was 89 million CNY, down 20.70% year-on-year [1] Group 2: Business Segment Performance - The nuclear medicine segment generated sales of 503 million CNY, a year-on-year increase of 0.78% [2] - Key product 18F-FDG sales reached 212 million CNY, up 8.72% due to increased sales volume [2] - Yunk injection sales were 116 million CNY, down 5.69% [2] - Iodine-125 sealed source sales were 70.89 million CNY, down 8.34% [2] - The raw material drug segment reported sales of 611 million CNY, a year-on-year decrease of 7.02% [2] - Heparin raw material sales were 440 million CNY, down 8.90% due to price declines [2] - Glucosamine sulfate sales were 165 million CNY, up 4.26% [2] - The formulation segment achieved sales of 182 million CNY, a year-on-year increase of 1.76% [2] Group 3: Research and Development - R&D expenses for the first half of 2025 totaled 121 million CNY, with 94.75 million CNY being expensed and 26.39 million CNY capitalized [10] - Ongoing clinical trials include: - 18F-SR peptide injection in Phase III [2] - 18F-alpha peptide injection in Phase III [2] - 18F-fibrin inhibitor and 177Lu-LNC1011 in Phase II [2] Group 4: Market and Regulatory Developments - 27 provinces and regions in China have issued medical service price lists, separating examination fees from drug costs, which is expected to boost FDG sales [4] - The company’s products, including Technetium-99m and Fluorine-18, are included in the 2025 medical insurance preliminary review directory, with negotiations expected to conclude in November [6] Group 5: Production Capacity and Infrastructure - The company operates 7 single-photon and 22 positron emission nuclear medicine production centers, with 31 centers in total, covering 93.5% of the domestic nuclear medicine demand [3] - The production center network is a core competitive advantage for the company [3] Group 6: Future Prospects and Strategic Directions - The company is exploring the combination of nuclear medicine with other treatment methods due to the complexity of tumors [15] - New targeted therapies are under development, including those targeting FAP and somatostatin receptors [16]
东诚药业上半年核药业务收入增长,总裁罗志刚去年涨薪、董事长由守谊降薪
Sou Hu Cai Jing· 2025-08-15 10:17
Financial Performance - Company reported a revenue of 1.384 billion yuan, a decrease of 2.60% year-on-year [1][2] - Net profit attributable to shareholders was 88.65 million yuan, down 20.70% year-on-year [1][2] - The net profit after deducting non-recurring gains and losses was 80.47 million yuan, compared to 105.75 million yuan in the previous year [2] Business Segments - The nuclear medicine segment generated sales of 503 million yuan, an increase of 0.78% year-on-year, with the key product 18F-FDG achieving 212 million yuan in revenue, up 8.72% due to increased sales volume [1] - The raw material drug segment reported sales of 611 million yuan, a decline of 7.02%, with heparin raw material sales at 440 million yuan, down 8.90% due to falling prices [1] - The formulation segment achieved sales of 182 million yuan, an increase of 1.76%, with the key product nadroparin calcium injection generating 77.29 million yuan, up 6.30% [1] Dividend Policy - Company plans not to distribute cash dividends, issue bonus shares, or increase capital from reserves for the half-year period [1] Management Information - Chairman of the company is You Shouyi, aged 64, and the President is Luo Zhigang, aged 55 [2]
东诚药业:上半年营收下滑2.6%至13.84亿元,硫酸软骨素产品收入上升4.26%
Cai Jing Wang· 2025-08-14 15:06
Core Insights - Dongcheng Pharmaceutical reported a 2.6% decline in revenue for the first half of 2025, totaling 1.384 billion yuan, with net profit attributable to shareholders decreasing by 20.70% to 88.6525 million yuan [1] Revenue Breakdown - The nuclear medicine segment generated sales of 503 million yuan, a year-on-year increase of 0.78%, with the key product F-FDG achieving revenue of 212 million yuan, up 8.72% due to increased sales volume [1] - The sales of Yunk injection solution reached 116 million yuan, down 5.69% year-on-year, while iodine-sealed seeds generated revenue of 70.8919 million yuan, a decrease of 8.34% [1] - The raw material drug segment reported sales of 611 million yuan, a decline of 7.02%, with heparin raw material products generating 440 million yuan, down 8.90% primarily due to falling sales prices of heparin sodium [1] - Chondroitin sulfate products achieved sales of 165 million yuan, an increase of 4.26% [1] - The formulation segment recorded sales of 182 million yuan, a year-on-year increase of 1.76%, with the key product nadroparin calcium injection generating revenue of 77.2931 million yuan, up 6.30% [1]