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第四批鼓励仿制药品目录发布,涉及抗肿瘤、神经系统等领域用药
Bei Jing Shang Bao· 2026-01-04 09:45
据悉,第四批目录继续以患者治疗需求为导向。针对我国企业研发薄弱环节,优先收录新靶点、新作用 机制产品。如缓解血液透析患者慢性肾病相关中重度瘙痒的地非法林;4个境内未上市放射性药品,涵 盖治疗、诊断和定位用药。 北京商报讯(记者王寅浩宋雨盈)1月4日,国家卫生健康委联合工业和信息化部、国家知识产权局、国家 医保局、国家药监局等部门组织专家对国内专利即将到期及临床供应短缺(竞争不充分)的药品进行遴选 论证,制定了《第四批鼓励仿制药品目录》。第四批目录收录21个品种、47个品规,收录药品涉及抗肿 瘤、神经系统、辅助生殖、放射性诊断等领域用药。 ...
四川省药品监督管理局奋力书写“十四五”药品安全答卷 固本强基守底线 改革创新追高线
Si Chuan Ri Bao· 2025-12-25 07:45
四川省药品监督管理局工作人员正在进行放射性药品检测。 四川省凉山州布拖县牛角湾镇毫沟村的药田边,四川省药品监督管理局(以下简称省药监局)派驻人员带领 着专家,向当地农户细致讲解如何做好白及、穿心莲等药材的品质管控;成都医学城的工作站里,重点药械项目 专班成员正在提供覆盖从政策解读到注册申报的全周期"零距离"指导;药品质量检验检测行业技能竞赛的现场, 选手们一一辨识药材的性状、测定药物的成分……一幅幅生动画面,勾勒出"十四五"期间四川药品监管系统履职 尽责的行动图景。 5年来,省药监局始终坚持"讲政治、强监管、保安全、促发展、惠民生"的工作思路,高质量统筹发展与安 全、效率与公平、监管与服务,织就一张覆盖药品全生命周期的立体防护网。 构建"多元化"体系 实现药品高效能监管 随着药品监管改革的深入推进,药品监管体制机制显得尤为重要。如何建立科学高效权威的药品监管体 系?"十四五"时期,省药监局不断强化责任落实,夯实技术支撑,壮大监管队伍,凝聚社会力量,着力构建"政府 领导、部门协同、社会共治"的监管体系。 权责明晰使监管更有效。在全省药品监管"一盘棋"布局下,强化药品安全责任体系建设,持续完善"3层级+5 片区" ...
东诚药业:控股子公司获得放射性药品生产许可证
Xin Lang Cai Jing· 2025-12-03 09:17
东诚药业公告,近日收到控股子公司烟台蓝纳成生物技术股份有限公司的通知,通知其收到山东省药品 监督管理局下发的《放射性药品生产许可证》。 ...
重药控股与华益科技签署战略合作协议
Core Insights - Zhongyao Holdings (重药控股) has signed a strategic cooperation agreement with Huayi Technology (华益科技) on November 28, focusing on technological collaboration and innovative business models [1] Group 1: Strategic Cooperation - The agreement emphasizes close collaboration across the "production, research, and sales" segments to maximize cooperative potential [1] - The partnership aims to enhance the value of the entire industry chain in the field of radioactive pharmaceuticals [1] Group 2: Industry Positioning - The collaboration is expected to establish a strategic layout advantage in the radioactive pharmaceutical sector [1]
南京医药股份有限公司关于2025年半年度业绩说明会召开情况的公告
Summary of Key Points Core Viewpoint - The company held its 2025 semi-annual performance briefing on September 18, 2025, to discuss its business strategies and performance metrics, focusing on digital transformation and new business models in the pharmaceutical industry [1]. Group 1: Company Performance and Strategy - The company aims for a minimum of 28% revenue growth in its emerging business for 2025 compared to 2024, with new business revenue reaching 851 million yuan in the first half of 2025 [2]. - The company reported that its SPD and "Internet+" businesses contributed approximately 3.3 billion yuan in revenue, accounting for about 12% of total revenue in the first half of 2025 [3]. - The company is actively managing its market value through share buybacks and strategic planning to enhance shareholder value and operational efficiency [3]. Group 2: Financial Metrics and Challenges - The company noted a significant divergence between net profit and operating cash flow, primarily due to an increase in accounts receivable, which the company plans to address through improved management [2]. - The company issued 4 billion yuan in short-term financing bonds to repay high-interest bank loans, indicating no immediate debt repayment pressure [3]. - The company’s gross margin for wholesale business is approximately 5.5%, while the gross margin for its emerging e-commerce business is around 15%, indicating higher profitability in new business models [5]. Group 3: Industry Outlook - The pharmaceutical distribution industry is expected to grow due to factors such as rising disposable income, increased health awareness, and an aging population, which will drive demand for healthcare and pharmaceutical products [4]. - The company is focusing on optimizing its economic structure and enhancing its supply chain capabilities to improve overall efficiency and profitability [4].
江苏省:支持脑机接口设备、医用机器人等前沿技术产品研发
Core Viewpoint - Jiangsu Province has issued policies to promote deep reforms in drug and medical device regulation, aiming to enhance the high-quality development of the pharmaceutical industry [1] Group 1: Support for Innovation - The policies emphasize support for the research and development of innovative products, focusing on areas such as innovation, clinical needs, and rare disease treatments [1] - A series of provincial science and technology projects will be implemented to support the development of cutting-edge medical technologies, including cell and gene therapy drugs, foreign-approved drugs, radioactive drugs, medical robots, and brain-computer interface devices [1] Group 2: Enhancement of Testing and Monitoring Capabilities - The initiative includes advancing the construction of testing platforms in emerging fields such as brain-computer interfaces and artificial organs [1] - The goal is to create advantageous testing projects in the field of medical acoustics [1]
国家药监局副局长黄果在四川调研放射性药品研发工作
news flash· 2025-07-18 13:06
Core Viewpoint - The National Medical Products Administration (NMPA) is actively engaging with the radioactive pharmaceutical industry to enhance research, quality management, and regulatory science [1] Group 1 - The NMPA's deputy director, Huang Guo, led a team to visit radioactive pharmaceutical R&D and production companies in Sichuan [1] - The visit included discussions on the development of radioactive pharmaceuticals and the importance of comprehensive quality management [1] - The focus of the research also included regulatory science, indicating a commitment to improving oversight in this sector [1]
天津滨海机场物流公司开展七类放射性物质运输安全培训
Core Viewpoint - The training conducted by Tianjin Binhai Airport Logistics Company aims to enhance the compliance and safety of air transportation of Class 7 radioactive materials in response to the regulatory needs of Tianjin City [1][2]. Group 1: Training Overview - The training included two main modules: one focused on the full-chain management of radioactive pharmaceuticals, presented by a lecturer from Tianjin Hengrui Medicine Co., which covered drug classification characteristics, transportation safety regulations, and emergency response processes [2]. - The second module featured experts from Tianjin Inspection, who provided a comprehensive interpretation of the ICAO TI-2025 international rules, including packaging levels, exemption transport conditions, and dose limits [2]. Group 2: Practical Application - The training emphasized a dual approach of "regulations + practical operations" to address issues faced by frontline personnel regarding classification standards, declaration documents, and emergency response [2]. - The goal of the training was to ensure that relevant personnel master the core regulations of Class 7 radioactive material transportation, thereby translating training outcomes into compliance guarantees in actual operations [2].