持续提升审评审批质效方面。《若干措施》提出，要深化与国家药监局药审中心、器审中心的协同，对 重点创新产品实行"提前介入、一企一策、全程指导、研审联动"。 河北省药品监督管理局党组书记 局长 王峰山：将药品补充申请审评时限，由200个工作日压缩至60个工 作日，为创新药械上市按下"快进键"，力争"十五五"期间，我省创新药、创新医疗器械申报数量年均增 长20%以上。 （来源：河北新闻网） 转自：河北新闻网 冀时客户端报道 12月31日，省政府新闻办举行发布会，对日前印发实施的《关于支持创新药械高质量 发展若干措施》进行解读。 《若干措施》以全链条支持创新药械高质量发展为主线，共包含五个部分： 支持自主研发创新和成果转化方面。我省将建设由政府主导的药物安全性评价研究共享平台，为企业提 供从临床前安全性评价到临床生物样本分析的全链条、一站式技术服务，降低企业研发成本，从源头加 快研发进程。 提升医药产业合规水平方面。《若干措施》提出，积极推进药械智慧监管和非现场监管，对合规守信企 业减少现场检查频次。推动京津冀药品批发企业许可同质同标，构建多仓协同物流管理模式，降低企业 跨区域经营成本，提升京津冀药品市场一体化水平。 ...

五年来，质量强市战略深入实施。南通现有中国质量奖提名奖4项、江苏省省长质量奖及提名奖23 项，"江苏精品"总量达127个；"旗舰领航"行动为504家龙头骨干企业提供诊断服务，19个质量合作社为 6.8万家中小微企业提供"一站式"质量服务，培育首席质量官超万人；通州家纺入选国家级小微企业质 量管理体系认证提升行动区域试点，海门区入围全国百城质量认证活动名单；主导或参与制修订国际、 国家标准达500项，立项国家级、省级标准化试点项目36个。 校对陶善工 五年来，全国知识产权"双示范"城市建设成效显著。推动出台《南通市知识产权保护和促进条例》，推 进专利培育"滴灌计划"、专利转化"雨露计划"、知识产权风险防范"指南针（300803）计划"、商业秘密 保护"保险箱计划""四大计划"，全市有效发明专利量超5.7万件、万人高价值发明专利拥有量达28件， 较"十三五"末翻一番，专利转让许可超4万件，服务企业超5000家；侵权纠纷"快调速裁、简案快办"模 式压缩办案周期50%以上。 扬子晚报网讯(记者朱亚运)12月31日，南通市政府新闻办召开南通市高质量完成"十四五"规划系列主题 新闻发布会，南通市场监管局介绍"十四五"时期 ...

此外，四川将从强化金融支持、加强知识产权保护、加强人才队伍建设等方面，持续构建产业发 展良好生态。 《政策措施》提出，优化创新药械审评审批服务，将审评时限由200个工作日缩短至60个工作日， 第二类医疗器械技术审评时限缩短至35个工作日；持续强化创新医药生产流通，对纳入药械管理 的货物、物品，不再实施进出境特殊物品卫生检疫审批。 《政策措施》鼓励高校、院所、企业共建药械研发平台等，建立医工研发咨询合作机制，建设研 发转化信息发布"一张网"，推进医企供需在线对接。同时，支持将符合条件的临床试验和转化项 目按程序纳入省级科技计划项目体系。《政策措施》明确，将创新药械临床试验开展量等纳入临 床医学研究中心年度考核和周期评估指标，对推进创新药械应用成效良好的，在当年度公立医院 监测中予以加分倾斜，同时将科技成果转化应用绩效纳入职称评定、晋升评价体系等。 ●将创新药械临床试验开展量等纳入临床医学研究中心年度考核和周期评估指标 本报讯（四川日报全媒体记者 文露敏）近日，《四川省支持生物医药和医疗器械产业高质量发展 若干政策措施》（下称《政策措施》）印发，提出提升高质量创新研发能力、提升创新药械临床 研究质效等7方面21条 ...

新华社记者 侠克 阳娜 记者了解到，为了能让创新活力持续迸发，北京不断完善全要素保障体系。在资金支持方面，新设立了 200亿元规模医药健康领域的专项产业基金，截至目前完成投决项目77个。此外，通过直接补助、后补 贴、基金等多种资金投入方式加大对医药产业全链条发展的支持力度。 作为首都高精尖产业主阵地和医药健康产业主要承载区，北京经济技术开发区聚集各类生物医药企业超 5000家，涵盖了生物药、现代中药、新型疫苗、高端医疗装备等医药健康产业全领域。2025年以来，已 有2个创新药和3个创新医疗器械获批上市。 今年10月25日，阿斯利康正式启用位于北京经济技术开发区国际医药创新公园的阿斯利康全球研发北京 战略中心。该中心依托北京的科学生态系统和在人工智能领域的优势，加速推进新一代创新药物的研 发。 阿斯利康全球高级副总裁、全球研发中国负责人何静表示，阿斯利康在北京的全球研发布局将极大获益 于经开区的支持、配套设施以及完善的医药研发生态圈建设，中心将加强与研究型医院、高等院校以及 生物科技公司等合作，提升从药物发现到临床开发到新药获批全链条的科学成果转化。 政策创新是产业加速发展的"催化剂"。2024年、2025年北 ...

执业证书编号：S1410524050001 近十二个月行业表现 % 1 个月 3 个月 12 个月 相对收益 -1.87 -9.27 -6.57 绝对收益 0.71 -7.79 9.74 数据来源：聚源 注：相对收益与沪深 300 相比 证券研究报告·行业点评报告 2025 年 12 月 22 日 江海证券研究发展部 1. 江海证券-行业点评报告-医药生物行 业：中国创新药 BD 交易持续火爆，"出海 +升级"成核心增长引擎 – 2025.12.16 2. 江海证券-行业点评报告-医药生物行 业：信达生物与武田制药重磅合作完成交 割，"创新+国际化"再证实力 – 2025.12.15 3. 江海证券-行业点评报告-医药生物行 业：首版商保创新药目录发布，开辟高值 创新药支付新路径 – 2025.12.11 4. 江海证券-行业点评报告-医药生物行 业：宁夏深化药械监管改革，推动医药产 业高质量发展 – 2025.10.31 5. 江海证券-行业点评报告-医药生物行 业：艾迪药业核心原料药获批，国产抗艾 产业链竞争力提升 – 2025.10.31 医药行业研究组 分析师：吴春红 四川出台全链条产业政策，本地医药 ...

Group 1: National Power Market Evaluation System - The National Development and Reform Commission and the National Energy Administration have issued a notification to establish a nationwide unified power market evaluation system focusing on four key areas: market operation effectiveness, market role performance, sustainable development of operating entities, and market competition adequacy [2][3] - The evaluation aims to create a scientific, systematic, and dynamic power market evaluation framework that balances multiple objectives such as security of supply, green transition, and economic efficiency [2][3] - The evaluation work will be organized by the National Development and Reform Commission and the National Energy Administration, with participation from market operators, universities, and research institutions [3] Group 2: High-Quality Development of Service Outsourcing - The Ministry of Commerce and six other departments have released an action plan to promote high-quality development in the service outsourcing sector, aiming to cultivate a number of internationally competitive leading enterprises by 2030 [4][5] - The action plan includes six specific measures focusing on enhancing platform capabilities, fostering innovation, nurturing key players, expanding market access, developing industry standards, and training talent [4][5] - The plan emphasizes the integration of digital economy with the real economy, promoting the development of international data service businesses and establishing a data service industry chain [5] Group 3: Antitrust Compliance Guidance - The State Administration for Market Regulation has introduced compliance guidelines addressing eight new types of monopoly risks for platform enterprises, including algorithm collusion and unfair pricing practices [6][8] - The guidelines aim to help platform operators identify, assess, and prevent antitrust compliance risks, promoting a shift from reactive enforcement to proactive compliance management [7][8] - The guidelines encourage platforms to develop internal management systems for antitrust compliance, ensuring sustainable development and healthy market competition [8] Group 4: Element Market Reform in Henan Province - The Henan Provincial Government has released a comprehensive reform pilot plan for market-oriented allocation of factors, proposing 70 specific measures to enhance the flow and efficient allocation of resources [10][11] - The plan includes initiatives to promote technological innovation, improve land allocation efficiency, facilitate human resource mobility, and establish data circulation rules [10][11][12] - The plan aims to support the development of high-end equipment, new materials, and biomedicine sectors through the establishment of verification centers and pilot bases [10][11] Group 5: Support for Biomedicine and Medical Devices in Sichuan Province - The Sichuan Provincial Government has issued policies to support the high-quality development of the biomedicine and medical device industries, including financial incentives for innovative drugs and devices [13][14] - The policies focus on enhancing research capabilities, improving clinical trial quality, and optimizing approval processes for innovative products [13][14] - The initiative aims to create a favorable ecosystem for industry development, including support for intellectual property protection and financial leasing for medical equipment [14] Group 6: Innovative "Rent-Equity Linkage" Mechanism in Zhejiang - The Taizhou Bay New Area in Zhejiang has introduced a "rent-equity linkage" mechanism to alleviate financial pressures on startups while enhancing the park's service capabilities [16][17] - This model allows selected high-potential tech companies to defer rent payments, enabling them to focus on research and market expansion [16][17] - The mechanism aims to foster a long-term partnership between the park and enterprises, facilitating investment and shared growth opportunities [17]

央视网消息：封关运作为海南自贸港建设注入强劲动能。这几天，设于海南省海口市的广东海南先进制造业合作产业园正加快建设。据了解，广东海南 先进制造业合作产业园目前已累计引进企业831家、完成投资35.8亿元。湘琼共建产业园已累计引进合作企业31家，计划总投资139.72亿元。越来越多的企业 借助海南自贸港政策优势从这里扬帆远航。其实，对很多企业来说，落户只是第一步，后续有更多的实际问题需要解决。针对于此，海南也在推出一系列务 实举措，助力化解企业的"急难愁盼"，赋能落户企业高质量发展。 高慧不仅是海口国家高新区党政办的干部，她还是这家企业的"企业秘书"，也就是联络员，这个创新产品第一阶段的收录工作就是在她的帮助下完成 的。高慧表示："这个产品进入到医院现在已经完成了第一步，接下来，我们会再去联系卫健委，再去联系医保部门，把该完成的目录、该走的这些途径都 给解决了。如果在高新区的层面协调解决这些部门存在困难，我们会逐级上报，由海口市级层面统筹力量帮企业攻克难关。" 贺勇慎是海南一家医疗科技企业的负责人。这段时间，企业研发注册了一种创新医疗器械，需要通过省级创新目录进入本省医疗机构临床使用。他 说："如果我们自己去对 ...

Core Viewpoint - The article emphasizes the importance of strict and efficient regulation in promoting the development of innovative drugs and medical devices in China, highlighting the achievements and future plans of the National Medical Products Administration (NMPA) in ensuring drug safety and supporting industry innovation [1]. Group 1: Achievements During the 14th Five-Year Plan - The NMPA has implemented comprehensive reforms in drug regulation, ensuring overall stability in drug safety and advancing the construction of a strong pharmaceutical nation [2]. - Continuous strengthening of supervision has led to a significant increase in the overall pass rate of drug safety inspections from 97.8% during the 13th Five-Year Plan to 99.4% [2]. - A total of 220 innovative drugs and 282 innovative medical devices have been approved, marking increases of 6.2 times and 3.1 times, respectively, compared to the previous five-year period [3]. Group 2: Future Measures for Drug Safety Regulation - The NMPA plans to enhance the drug safety responsibility system and transition from a "passive defense" to a "proactive prevention" approach [5]. - A focus on dynamic safety regulation across the entire supply chain will be implemented, addressing new challenges posed by product and technological innovations [6]. - Strict enforcement against illegal activities will be prioritized, with improved mechanisms for cross-regional and cross-level case handling [6]. Group 3: Support for Innovative Drug and Medical Device Development - The NMPA will support enterprises in enhancing their research and development capabilities for innovative drugs and medical devices, emphasizing the importance of effective market and proactive government roles [7]. - Policies will be optimized to accelerate the approval process for innovative products, particularly those that are globally novel or critical for domestic substitution [8]. - The NMPA aims to improve the regulatory framework for traditional Chinese medicine, ensuring quality management and modernization of production processes [8]. Group 4: Enhancing Public Benefit from Regulatory Reforms - The NMPA will prioritize enhancing public access to innovative treatments and ensuring that regulatory reforms benefit the general population [9]. - Efforts will be made to streamline the approval process for urgently needed drugs, including those for rare diseases and pediatric use [9]. - Collaboration with health and insurance departments will be strengthened to ensure comprehensive drug safety and accessibility [10].

Core Viewpoint - The article emphasizes the importance of strict regulation in promoting the development of innovative drugs and medical devices, highlighting the balance between ensuring drug safety and fostering industry innovation [1] Group 1: Achievements in Drug Regulation - Since the 14th Five-Year Plan, China's drug regulatory system has adhered to the "four strictest" requirements, leading to a stable drug safety situation and significant progress in building a strong pharmaceutical nation [2] - The overall pass rate for national drug sampling inspections increased from 97.8% during the 13th Five-Year Plan to 99.4% [2] Group 2: Promoting Industry Innovation - A total of 220 innovative drugs and 282 innovative medical devices were approved since the 14th Five-Year Plan, representing 6.2 times and 3.1 times the approvals during the 13th Five-Year Plan, respectively [3] - The approval of 415 children's drugs and 155 rare disease drugs, along with 28 innovative traditional Chinese medicines, indicates a growing vitality in pharmaceutical innovation [3] Group 3: Future Measures for Drug Safety - The regulatory focus will shift from "passive defense" to "active prevention," enhancing the drug safety responsibility system and improving risk management capabilities [4] - A comprehensive dynamic safety supervision system will be established, covering the entire lifecycle of drugs, from research and development to production and use [5] Group 4: Supporting Innovation in Pharmaceuticals - The regulatory body will support enterprises in enhancing their innovative drug and medical device research and development, emphasizing policy guidance and resource allocation for original products [6] - Efforts will be made to accelerate the market entry of innovative drugs and medical devices by optimizing registration processes and reducing costs [7] Group 5: Enhancing Public Welfare - The regulatory work will prioritize enhancing public satisfaction and safety, ensuring that regulatory reforms benefit all citizens and meet their health needs [8] - Measures will be taken to expedite the approval of urgently needed drugs, including those for rare diseases and children, while maintaining high standards [9] Group 6: Interdepartmental Collaboration - Strengthening coordination with health and insurance departments will be crucial for improving clinical trial oversight and drug traceability systems [10] - Public awareness campaigns will be conducted to enhance understanding of drug regulations and promote a supportive environment for innovative drug and device development [11]

Core Viewpoint - The article emphasizes the importance of strict and efficient regulation to promote the development of innovative drugs and medical devices in China, highlighting the achievements and future plans of the National Medical Products Administration (NMPA) in ensuring drug safety and supporting industry innovation [1][2]. Regulatory Achievements During the 14th Five-Year Plan - The NMPA has implemented comprehensive reforms in drug regulation, leading to a stable drug safety situation and significant progress in building a strong pharmaceutical nation [2]. - The overall pass rate for national drug sampling inspections increased from 97.8% during the 13th Five-Year Plan to 99.4% [2]. Industry Innovation and Development - A total of 220 innovative drugs and 282 innovative medical devices were approved during the 14th Five-Year Plan, representing 6.2 times and 3.1 times the approvals during the 13th Five-Year Plan, respectively [3]. - The NMPA has also approved 415 children's drugs and 155 rare disease drugs, along with 28 innovative traditional Chinese medicines [3]. Strengthening Regulatory Capacity - The NMPA has revised key regulatory laws and established a more comprehensive legal framework for drug regulation, enhancing the consistency of Chinese standards with international standards [4]. - The establishment of new inspection centers and regional review centers has improved the regulatory capacity of the NMPA [4]. Transition to Proactive Drug Safety Management - The NMPA aims to shift drug safety management from a "passive defense" approach to a "proactive prevention" model, enhancing risk identification and responsibility accountability [5]. - A dynamic safety supervision mechanism covering the entire lifecycle of drugs is being developed to address new challenges in product and technology innovation [6]. Support for Innovative Drug and Medical Device Development - The NMPA plans to enhance support for the research and development of innovative drugs and medical devices, focusing on policy guidance and resource allocation for original products [7]. - Efforts will be made to streamline the approval process for innovative products and improve the protection of intellectual property rights related to drug research [8]. Ensuring Public Benefit from Regulatory Reforms - The NMPA is committed to ensuring that regulatory reforms benefit the public, focusing on enhancing people's sense of gain, happiness, and safety [9]. - The agency will expedite the approval of urgently needed drugs and maintain high standards for generic drug quality to ensure affordable access to effective medications [9]. Collaborative Governance in Healthcare - Strengthening collaboration with health and insurance departments is essential for improving clinical trial oversight and drug traceability [10]. - The NMPA will enhance public awareness of drug safety and regulatory policies through education and outreach initiatives [10].