转自：北京日报客户端 1月6日至7日，全国药品监督管理工作会议在北京召开。会议以习近平新时代中国特色社会主义思想为 指导，全面贯彻落实党的二十大和二十届历次全会精神，认真落实中央经济工作会议部署，总结2025年 和"十四五"药品监管工作，分析当前面临形势，部署2026年重点任务。市场监管总局党组书记、局长罗 文出席会议并讲话。市场监管总局党组成员，国家药监局党组书记、局长李利作工作报告。国家药监局 党组成员、副局长徐景和、黄果、雷平、杨胜，中央纪委国家监委驻市场监管总局纪检监察组负责同志 出席会议。 会议指出，2025年，全国药监系统认真落实习近平总书记"四个最严"要求，全面加强党的领导和党的建 设，全过程深化药品监管改革，全方位筑牢药品安全底线，全链条支持医药产业高质量发展，新批准创 新药和医疗器械数量创历史新高，全国药品安全形势保持总体稳定，人民群众对药品监管的获得感进一 步充实，为"十四五"时期药品监管改革发展画上圆满句号。五年来，药品监管部门服务国家区域发展战 略取得新进展，药品安全保障水平得到新提升，医药产业创新发展实现新跨越，药品监管国际话语权达 到新高度，监管现代化水平迈上新台阶，《"十四五"国 ...

Core Viewpoint - The implementation of the "Implementation Opinions" by the Shandong Provincial Government aims to enhance the innovation capability, optimize the industrial structure, and strengthen the international competitiveness of the pharmaceutical industry in Shandong [1]. Group 1: Specific Measures - The "Implementation Opinions" outlines 29 specific measures across six areas, focusing on strengthening pharmaceutical innovation, optimizing the clinical trial ecosystem, deepening review and approval reforms, promoting clinical application, advancing international development, and enhancing quality supervision [2][3]. Group 2: Key Features - The "Implementation Opinions" emphasizes a systematic integration approach, creating a comprehensive policy framework that spans from research and development to usage, innovation to regulation, and domestic to international [4]. - It highlights innovation-driven strategies, proposing specific measures such as research subsidies, strategic investments, and pilot support to foster key areas like cutting-edge technologies and platform development [4]. - The initiative aims to optimize the business environment by reforming review and approval processes, enhancing clinical trial ecosystems, and improving inspection efficiency to reduce institutional transaction costs [4]. - It reinforces clinical application by expediting the market entry of innovative products, standardizing pharmaceutical committee processes, and optimizing medical insurance payment policies [4]. - The focus on open development includes practical measures for internationalization, such as targeted investment attraction, support for overseas expansion, and international certification [4]. - The "Implementation Opinions" also stresses the importance of maintaining safety standards by ensuring accountability, enhancing smart supervision, and strictly combating illegal activities to guarantee the safety and efficacy of pharmaceuticals and medical devices [4].

中国青年报客户端讯（中青报·中青网记者刘言）第十届北京国际医药健康交流会暨京津冀医药产业协 同展示活动12月19日在北京市大兴区营商服务中心举行，来自京津冀三地的政府部门、科研机构、高等 院校、医疗机构、领军企业及行业组织的代表200余人，共同回顾发展成就、剖析时代挑战、擘画未来 蓝图，为推动医药健康产业创新协同与高质量发展凝聚广泛共识。 据介绍，本届大会以"擘画笃行，医药产业高质量发展新航程"为主题，旨在深入贯彻国家推动医药产业 高质量发展的战略部署，全面落实创新驱动发展要求，积极构建医药健康产业新生态，持续推动京津冀 协同发展迈向更高阶段。 河北省工业和信息化厅总工程师毛红领通过视频连线介绍了河北生物医药产业的发展成果。他表示，河 北省正以更大力度深化与京津合作，围绕生物医药产业发展需求，以企业为主体，联合高校、科研院所 组建创新联合体，整合各方资源，构建协同创新机制。 交流活动设置了"医药产业高质量发展"主场交流、"生物医药协同发展新征程"京津冀活动专场以及"多 元化发展的北京中药"中医药专场活动三个平行分论坛，与会专家、企业代表聚焦医疗器械创新监管、 京津冀生物医药协同发展以及推动中医药产业高质量发展 ...

Core Viewpoint - The article emphasizes the importance of drug safety and regulatory reforms in China, highlighting achievements during the 14th Five-Year Plan and outlining strategies for the 15th Five-Year Plan to enhance drug safety and support innovation in the pharmaceutical industry [1][2]. Achievements During the 14th Five-Year Plan - The national 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]. - Continuous strengthening of regulation has ensured drug quality and safety, with over 200,000 batches of drugs and 20,000 batches of medical devices tested annually, resulting in an overall drug inspection pass rate increase from 97.8% to 99.4% [2][3]. Innovation and Development Support - A series of measures have been implemented to promote innovation in the pharmaceutical and medical device sectors, with 220 innovative drugs and 282 innovative medical devices approved, marking increases of 6.2 times and 3.1 times, respectively, compared to the previous five-year period [3][4]. - The approval of 415 children's drugs and 155 rare disease drugs has further enhanced the vitality of innovation in the pharmaceutical industry [3]. Regulatory Capacity Enhancement - Revisions to key regulatory laws and the establishment of a comprehensive legal framework for drug regulation have been prioritized, alongside significant advancements in drug regulatory information technology [4]. - The establishment of specialized inspection centers and regional review centers has strengthened the capacity for drug regulation [4]. Transition to Proactive Drug Safety Management - The regulatory approach is shifting from "passive defense" to "active prevention," focusing on risk identification and responsibility enforcement to maintain drug safety [5][6]. - A dynamic safety supervision mechanism covering the entire lifecycle of drugs is being developed to address new challenges in product and technology innovation [5]. Support for Innovative Drug and Medical Device Development - The regulatory body aims to enhance the clinical value and technological content of innovative drugs and medical devices, supporting enterprises in their research and development efforts [7]. - Policies will be optimized to facilitate faster market entry for innovative products, including the implementation of a national drug standard improvement plan [8]. Ensuring Public Benefit from Regulatory Reforms - The regulatory work will prioritize enhancing public satisfaction and safety, ensuring that the benefits of reforms reach all citizens [9]. - Efforts will be made to expedite the approval of urgently needed drugs and improve the quality and efficacy of generic drugs [9]. Strengthening Social Cooperation and Public Awareness - Increased efforts in policy interpretation and public education on drug safety and regulatory measures are planned to enhance societal understanding and support for innovation in the pharmaceutical sector [10].

Core Viewpoint - The Jiangxi Provincial Government has issued implementation opinions to deepen the regulation reform of pharmaceuticals, medical devices, and cosmetics, aiming to promote high-quality development in the pharmaceutical industry [1] Summary by Relevant Sections Innovation Support Mechanism - The government plans to enhance innovation support mechanisms by initiating pilot programs for R&D services in pharmaceuticals, medical devices, and cosmetics [1] - A collaborative mechanism will be established between provincial drug regulatory departments and local governments to expedite the review process for innovative products [1] Regulatory and Policy Support - A "face-to-face" service mechanism will be set up to assist enterprises and R&D institutions in developing innovative products, with a focus on key drugs and medical devices that are prioritized for expedited registration [1] - The processing time for provincial-level related matters will be reduced by 15% [1] Financial Incentives - New 1st class innovative drugs and 3rd class innovative medical devices that generate economic benefits will receive a reward of 10 million yuan each, while newly approved generic chemical drugs will receive 2 million yuan each [1] - Local governments and park management committees are encouraged to implement reward and subsidy policies for national innovative drugs and other specified categories [1] Financing and Investment - Banks are encouraged to develop credit products tailored to the pharmaceutical industry's characteristics, focusing on long-term, low-collateral, and high-credit lending [1] - The provincial modern industry guidance fund and related science and technology innovation funds will be directed towards pharmaceutical companies with listing potential [1] - Pharmaceutical companies are supported in expanding financing channels through various means, including bond issuance and asset securitization [1]

Core Insights - The Shanghai government has issued measures to enhance the regulatory framework for pharmaceuticals and medical devices, aiming to promote high-quality development in the pharmaceutical industry [1] Regulatory Reforms - The measures include improving the review and approval mechanisms for drug and medical device registrations [1] - There will be pre-guidance for key products under research before registration applications, with a focus on provincial-level review and approval matters [1] - The implementation of pre-inspection and immediate review processes, along with smart review guidelines, is emphasized [1] Prioritization of Key Products - Key drugs under research and imported drugs transitioning to local production will receive priority for registration sampling and inspections [1] - Simultaneous registration verification and compliance checks for production quality management will be conducted [1] - For key medical devices under research, a pre-review service for the registration system will be provided, along with prioritized inspection [1] Support for New Enterprises - New medical device manufacturing companies that have passed on-site verification of the product registration system at the same production address, without authenticity issues or serious defects, may be exempt from on-site production license inspections [1]

Core Insights - The pharmaceutical sector has been experiencing fluctuations since September, following a strong rally, and is currently undergoing a rotation adjustment. The question arises whether the sector is worth attention after a valuation decline and if there is still growth logic in the pharmaceutical sector [1] Group 1: Policy Environment - The policy environment for the pharmaceutical industry is improving, with the National Healthcare Security Administration and the National Health Commission jointly releasing measures to support high-quality development of innovative drugs, providing comprehensive support across five key areas [2][4] - The implementation of ICH guidelines in China is promoting more efficient and scientific drug evaluation processes, enhancing regulatory frameworks [2] Group 2: Market Activity - October and November are traditionally high-frequency periods for business development (BD) transactions, with significant activity expected as companies aim to finalize annual procurement plans before the Christmas holidays. Notable transactions include a $100 million upfront deal by Innovent Biologics [5] - A record-breaking global strategic collaboration worth up to $11.4 billion was established between Innovent Biologics and Takeda Pharmaceutical, reflecting a robust trend in BD transactions for Chinese innovative drugs [6] Group 3: Valuation and Investment Opportunities - The Shenyin Wanguo Pharmaceutical Index is approximately 50% below its recent five-year price peak, indicating potential for valuation recovery [9] - The proportion of stock-type public funds heavily invested in the pharmaceutical sector has increased to 12.2%, showing a recovery trend, yet still below the historical average of 13.7%, suggesting room for further capital inflow [9][14] - For ordinary investors, investing in individual innovative drug stocks poses challenges due to the need for specialized tracking capabilities. Therefore, considering ETFs that cover industry leaders may be a more viable investment strategy [12] Group 4: Summary of Insights - The pharmaceutical industry is experiencing a favorable policy environment, with increasing BD transaction activity and potential for valuation recovery, indicating a supportive backdrop for future growth [14]

Core Viewpoint - The establishment of regional centers for drug and medical device review and inspection by the National Medical Products Administration (NMPA) is a significant step towards enhancing regulatory reforms and promoting high-quality development in the pharmaceutical industry in China [1] Group 1: Establishment of Regional Centers - The NMPA has set up review and inspection centers in Beijing-Tianjin-Hebei, Central China, and Southwest China from September 21 to 24 [1] - These centers aim to support major regional development strategies, including the coordinated development of Beijing-Tianjin-Hebei, the rise of Central China, and the promotion of Western development [1] Group 2: Goals and Objectives - The NMPA emphasizes high-level planning, construction, and quality development for these centers to align with regional industry characteristics [1] - The focus will be on building a professional and skilled team of reviewers and inspectors to enhance the efficiency of the review and inspection process [1] Group 3: Impact on the Pharmaceutical Industry - The initiative is expected to inject strong momentum into the high-quality development of China's pharmaceutical industry [1] - It aims to meet the public's expectations for the quality and safety of drugs and medical devices, as well as for innovation [1]

Core Insights - The Hang Seng Hong Kong Stock Connect Innovative Drug Index increased by 0.6%, while the CSI Innovative Drug Industry Index rose by 0.7%, the CSI Biotechnology Theme Index by 0.8%, the CSI Hong Kong Stock Connect Medical and Health Comprehensive Index by 1.1%, and the CSI 300 Medical and Health Index by 1.8% this week [1][3] - The Hang Seng Innovative Drug ETF (159316) saw a net inflow of 330 million yuan this week, bringing its total size to over 1.57 billion yuan, a record high [1] - The National Medical Products Administration's deputy director emphasized the commitment to ensuring drug safety and supporting high-quality development of the pharmaceutical industry during the "14th Five-Year Plan" period, with China's pharmaceutical industry ranking second globally and accounting for about 30% of the world's innovative drugs under research [1] Index Performance - Weekly performance of various indices: - Hang Seng Hong Kong Stock Connect Innovative Drug Index: +0.6% - CSI Hong Kong Stock Connect Medical and Health Comprehensive Index: +1.1% - CSI Innovative Drug Industry Index: +0.7% - CSI Biotechnology Theme Index: +0.8% - CSI 300 Medical and Health Index: +1.8% [3] - Year-to-date performance shows significant growth, with the Hang Seng Hong Kong Stock Connect Innovative Drug Index up by 112.0% and the CSI 300 Medical and Health Index up by 16.8% [6] Index Composition - The CSI Hong Kong Stock Connect Medical and Health Comprehensive Index consists of 50 stocks from the medical device, biopharmaceutical, chemical drug, and other healthcare sectors [4] - The CSI Innovative Drug Industry Index focuses on A-share innovative drug leaders, comprising no more than 50 stocks involved in innovative drug research and development [4] - The CSI Biotechnology Theme Index includes no more than 50 stocks related to gene diagnosis, biopharmaceuticals, blood products, and other human biotechnology [4]

Group 1 - The core viewpoint emphasizes the importance of drug safety and the comprehensive measures taken during the "14th Five-Year Plan" period to ensure drug safety and support the high-quality development of the pharmaceutical industry [1][3] - The Chinese pharmaceutical industry ranks second globally in terms of scale, indicating significant growth and development potential [3] - A total of 204 innovative drugs and 265 innovative medical devices have been approved, showcasing the country's commitment to innovation in healthcare [3] - Approximately 30% of the innovative drugs under research globally are from China, highlighting the country's increasing role in global pharmaceutical innovation [3] - 27 innovative traditional Chinese medicine drugs have been approved, reflecting the integration of traditional medicine into modern healthcare practices [3]