儿童用药
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上海:聚焦药品医疗器械重点领域和产品,建立在研重点品种服务清单
Xin Lang Cai Jing· 2025-11-24 09:55
Core Viewpoint - The Shanghai Municipal Government has issued measures to deepen the reform of drug and medical device regulation, aiming to promote high-quality development in the pharmaceutical industry, focusing on key areas such as cell and gene therapy, rare diseases, and pediatric medications [1] Group 1: Key Areas of Focus - The measures emphasize the importance of specific fields and products, including cell and gene therapy, rare diseases, pediatric medications, high-quality first generic drugs, artificial intelligence medical devices, medical robots, brain-machine interfaces, particle therapy equipment, and innovative traditional Chinese medicine diagnostic and treatment devices [1] Group 2: Regulatory Support - A service list for key varieties under research will be established, providing proactive guidance in clinical trials, registration and listing, inspections, and production licensing [1]
龙虎榜复盘 | 福建板块再度强势,天然气异动
Xuan Gu Bao· 2025-11-14 11:10
今天机构龙虎榜上榜41只个股,净买入18只,净卖出23只。当日机构买入最多的个股前三位是:时空科技(2.08亿)、海陆重工(1.41亿)、康芝药业 (1.18亿) 龙虎榜机构热股 | 上榜热股 | 实时涨跌幅♀ 买/卖家数↕ | | | --- | --- | --- | | 时空科技 605178.SS | +6.70% | 2/0 | | 海陆重工 002255.SZ | -1.57% | 3/0 | | 康芝药业 FC 700000 | +20.00% | 4/1 | 康芝药业 海南本地股,主营儿童用药,涵盖解热镇痛类、感冒类;全资子公司中山爱护专注于母婴健康护理产品,产品涵盖驱蚊液、驱蚊花露等驱蚊产品。、 龙虎榜知名游资 一、福建自贸 平潭发展 个股龙虎榜 A股唯一一家注册在平潭岛的上市公司,公司拥有90万亩林地,受益林业碳汇交易发展 三木集团 个股龙虎榜 旗下控股子公司福建融达通供应链管理有限公司,是福州跨境电商公共服务平台、跨境电商保税监管物流中心主要运营方 ,为跨境电商提供一站式平台对 接方案 二、天然气 首华燃气 个股龙虎榜 *免责声明:文章内容仅供参考,不构成投资建议 控股子公司中海沃邦主要 ...
我国儿童用药超90%非儿童专用药
第一财经· 2025-10-13 13:19
Core Viewpoint - The article emphasizes the growing focus on pediatric drug development in China, driven by regulatory incentives and the need to address unmet medical needs for children [3][5]. Group 1: Current State of Pediatric Drug Development - In the first five months of the year, China approved 57 pediatric drugs, significantly surpassing the previous year's figures, yet pediatric drugs still represent a small fraction of total drug approvals [3]. - Over 90% of pediatric medications are not specifically designed for children, with only about 60 out of over 3,500 approved chemical drug formulations being pediatric-specific [5][6]. - The pediatric drug supply system faces critical issues such as drug shortages, lack of evidence-based clinical use, and irrational clinical applications [5]. Group 2: Regulatory Support and Guidelines - The National Medical Products Administration (NMPA) has issued guidelines to encourage the development of modified new drugs for pediatric use, focusing on improving safety, efficacy, and adherence [3][6]. - The guidelines specify that pediatric drug development should prioritize the protection of children's rights and reduce unnecessary repetitive studies [7][11]. - The NMPA encourages the use of real-world evidence and extrapolation from adult data to address recruitment challenges in pediatric clinical trials [11][12][13]. Group 3: Challenges in Pediatric Drug Development - The development of pediatric drugs is complicated by difficulties in recruiting child participants for clinical trials, ethical considerations, high costs, and lengthy timelines [10]. - The NMPA emphasizes the importance of ensuring participant safety in pediatric clinical trials, advocating for the use of existing research evidence to minimize unnecessary studies [11]. - Ethical constraints often lead to reliance on adult data for pediatric drug trials, which may not accurately predict adverse reactions specific to children [12]. Group 4: Importance of Modified New Drugs - Modified new drugs are crucial for children due to their unique physiological characteristics and metabolic differences from adults, offering a lower-cost and shorter development cycle compared to innovative drugs [6][7]. - The NMPA's guidelines highlight the need for drug formulations that are suitable for children, including considerations for dosage, taste, and ease of administration [6][8].
龙虎榜复盘 | 雅江电站概念热度持续,海南自贸区爆发
Xuan Gu Bao· 2025-07-24 11:04
Group 1 - Institutions ranked 335 stocks today, with a net purchase of 21 stocks and a net sale of 14 stocks. The top three stocks with the highest net purchases were Lu'an Environmental Energy (397 million), Boyun New Materials (153 million), and Tianqi Lithium (126 million) [1] - Lu'an Environmental Energy saw a price increase of 7.34% with 4 buyers and no sellers, while Boyun New Materials decreased by 6.65% with 3 buyers and no sellers. Tianqi Lithium increased by 9.99% with 2 buyers and 1 seller [2] - Tianqi Lithium is recognized as the fourth largest global supplier of lithium chemical products and the second largest in China and Asia, having turned a profit year-on-year in the first quarter [2] Group 2 - The Hainan Free Trade Zone is set to implement a customs supervision special area by December 18, 2025, characterized by a policy of "opening up on one line, controlling on another line, and free movement within the island" [2] - The three-year action plan to boost and expand consumption in Hainan aims to increase the variety and quantity of "immediate purchase and immediate delivery" goods, with a projected sales figure exceeding 60 billion by 2027 for duty-free operations [3] - The "Yaxia" hydropower project has an estimated investment of approximately 705.6 billion, with an average annual investment of about 47 billion over a 15-year construction period, which is expected to significantly increase demand for construction materials and explosives [5]
赵刚主持召开省政府第二十五次常务会议
Shan Xi Ri Bao· 2025-07-22 00:15
Group 1: Administrative Law Enforcement - The provincial government is advancing a special action to standardize administrative law enforcement related to enterprises, focusing on addressing prominent issues raised by businesses to optimize the business environment and support high-quality development in Shaanxi [1] - The approach emphasizes a cycle of "rectification - standardization - enhancement," increasing efforts to investigate and rectify previously identified issues, while ensuring effective implementation of various tasks [1] - The government aims to create a coordinated "one chess game" framework, enhancing responsibility and guidance across all levels to ensure the special action is effectively implemented [1] Group 2: Food and Drug Safety - The meeting underscores the political and public significance of food and drug safety, advocating for the strictest standards, regulations, penalties, and accountability to ensure consumer safety [2] - A problem-oriented approach is emphasized, with a focus on enhancing local management responsibilities and supervision in key areas such as school canteens, farmers' markets, and emerging sectors like live-streaming sales [2] - Continuous improvement of local food and drug safety standards is encouraged to facilitate the transformation and upgrading of the province's specialty food and drug industries, thereby enhancing overall safety levels [2]
赵刚在省食品药品安全委员会全体会议上强调坚持“四个最严” 压紧压实责任全链条提升食品药品质量安全保障水平
Shan Xi Ri Bao· 2025-05-14 00:23
Core Points - The meeting emphasized the importance of food and drug safety as a critical issue for the public, highlighting the need for strict standards, regulations, and accountability in the industry [1][2] - The provincial government aims to enhance the quality and safety of food and drugs through comprehensive regulatory measures and the use of advanced technologies [2][3] Group 1 - The provincial government is committed to implementing the directives from the central government regarding food and drug safety, focusing on rigorous standards and strict enforcement [1][2] - There is a strong emphasis on enhancing supervision across all stages of food and drug production, distribution, storage, and sales, with clear responsibilities assigned to various stakeholders [2] - The meeting discussed the approval of key work arrangements for food and drug safety for the year 2025 [3] Group 2 - The government plans to address specific issues such as campus food safety, online food delivery, and the regulation of new food business models [2] - There is a focus on preventing issues through improved regulations and the integration of traditional inspection methods with new technologies like big data and AI [2] - The meeting highlighted the importance of community involvement in food safety oversight, encouraging public reporting and the use of delivery personnel as safety monitors [2]