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津药药业:子公司药品复合磷酸氢钾注射液通过仿制药一致性评价
Group 1 - The core point of the article is that Tianyao Pharmaceutical (600488) announced the approval of its subsidiary Tianyao Heping for the injection of compound potassium hydrogen phosphate by the National Medical Products Administration, indicating that the product has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 2 - The approval signifies a significant milestone for the company, enhancing its product portfolio in the pharmaceutical market [1] - The successful completion of the consistency evaluation may lead to increased market competitiveness and potential revenue growth for the company [1] - This development reflects the ongoing regulatory support for generic drugs in the industry, which may encourage further investments and innovations [1]
津药药业子公司复合磷酸氢钾注射液通过仿制药一致性评价
Zhi Tong Cai Jing· 2025-11-04 07:44
Core Viewpoint - Tianyao Pharmaceutical (600488.SH) announced that its subsidiary Tianyao Peace (Tianjin) Pharmaceutical Co., Ltd. received approval from the National Medical Products Administration for the potassium hydrogen phosphate injection, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Approval - The potassium hydrogen phosphate injection is a phosphorus supplement used to correct hypophosphatemia in adults and children when oral or enteral nutrition is not feasible, insufficient, or contraindicated [1] - The product is also indicated for parenteral nutrition in adults and children under similar conditions [1] Group 2: Research and Development - In July 2024, Tianyao Peace submitted a supplementary application for the consistency evaluation of the potassium hydrogen phosphate injection to the National Medical Products Administration, which has been accepted [1] - The cumulative R&D investment in the potassium hydrogen phosphate injection project by Tianyao Peace is approximately 9.21 million yuan [1]
津药药业(600488.SH)子公司复合磷酸氢钾注射液通过仿制药一致性评价
智通财经网· 2025-11-04 07:41
复合磷酸氢钾注射液作为磷补充剂,主要用于:(1)当口服或肠内营养无法进行、不足或有禁忌时,用 于纠正成人和儿童患者的低磷血症;(2)当口服或肠内营养无法进行、不足或有禁忌时,用于成人和儿童 患者的肠外营养。2024年7月津药和平向国家药品监督管理局药品审评中心提交复合磷酸氢钾注射液一 致性评价补充申请并获受理。截至目前,津药和平在复合磷酸氢钾注射液项目上累计研发投入约921万 元。 智通财经APP讯,津药药业(600488.SH)发布公告,近日,公司子公司津药和平(天津)制药有限公司(简 称"津药和平")收到国家药品监督管理局核准签发的复合磷酸氢钾注射液的《药品补充申请批准通知 书》,批准本品通过仿制药质量和疗效一致性评价。 ...
财信证券晨会纪要-20250630
Caixin Securities· 2025-06-29 23:53
Market Overview - The A-share market shows mixed performance with the Shanghai Composite Index closing at 3424.23, down 0.70%, while the Shenzhen Component Index rose by 0.34% to 10378.55 [2][3] - The total market capitalization of the Shanghai Composite Index is 6648.58 billion, with a price-to-earnings (PE) ratio of 12.27 and a price-to-book (PB) ratio of 1.27 [3] Industry Dynamics - BOE Technology Group showcased a glass-based Micro LED display at the International Display Week in San Jose, which is expected to change industry competition rules due to its lightweight and high brightness features [39] - Innovent Biologics received approval for its dual receptor agonist injection for long-term weight control, marking a significant advancement in obesity treatment [41] - Guangxi Petrochemical completed the trial operation of its 1.2 million tons/year ethylene unit, part of a larger integrated refining and chemical project [43] - The first batch of units from the 850,000 kW offshore wind power project by Guoxin Dafeng successfully connected to the grid, marking a significant milestone in Jiangsu's offshore wind power development [45] - Germany plans to build a 1.8 GWh battery storage project, which will enhance its energy storage capacity significantly [47] - The photovoltaic industry is experiencing price pressure following a surge in installations, with prices for silicon wafers declining [49] Company Tracking - Youyan New Materials announced the transfer of its lithium sulfide business assets, including patents and technology, to optimize its business focus [55] - Huadian New Energy plans to raise approximately 18 billion for wind and solar power projects as it prepares to list on the Shanghai Stock Exchange [57] - Spring Wind Power's new factory in Tongxiang aims to produce 3 million two-wheeled vehicles annually, marking a significant investment in the electric vehicle sector [59] - Taotao Industry has successfully developed its first humanoid robot prototype, indicating a strategic move into advanced manufacturing [61]
华纳药厂:复合磷酸氢钾注射液通过仿制药质量和疗效一致性评价
news flash· 2025-06-26 10:18
华纳药厂公告,公司收到国家药品监督管理局核准签发的关于复合磷酸氢钾注射液的《药品补充申请批 准通知书》。复合磷酸氢钾注射液主要用于纠正成人和儿童患者的低磷血症,以及成人和儿童患者的肠 外营养。该药品通过仿制药质量和疗效一致性评价,将有利于市场销售和市场竞争。 ...
多家企业角逐复合磷酸氢钾注射液市场,科伦药业成国产第二家过评药企!
Ge Long Hui· 2025-05-26 01:18
Core Viewpoint - Hubei Kelun Pharmaceutical has received approval for its generic drug, Compound Potassium Hydrogen Phosphate Injection, which is now recognized as the second domestic company to pass the consistency evaluation for this product [1][5]. Group 1: Product Overview - Compound Potassium Hydrogen Phosphate Injection is primarily used as a phosphorus supplement in total parenteral nutrition therapy for patients who need to fast for more than five days due to moderate or major surgeries or other traumas [3]. - The sales of this product exceeded 300 million yuan in 2023, marking a year-on-year growth of 33.55%. In the first two quarters of 2024, sales already surpassed 200 million yuan, with a year-on-year growth rate of 33% [3]. Group 2: Market Competition - A total of 11 companies, including Shijiazhuang Fourth Pharmaceutical and Tianjin Pharmaceutical, hold production licenses for Compound Potassium Hydrogen Phosphate Injection, with Shijiazhuang Fourth Pharmaceutical being the first to pass the evaluation [5]. - There are 30 companies, including Shandong Hualu Pharmaceutical and Chenxin Pharmaceutical, that have submitted applications for the generic version of this product, indicating a competitive market landscape [6]. Group 3: Company Achievements - Since 2025, Kelun Pharmaceutical (including subsidiaries) has had 13 products approved, including Tacrolimus Sustained-Release Capsules and Chloride Injection, with some being the first to pass the evaluation for their respective categories [8].