杨霆介绍，国家药监局通过提前介入、"一企一策"、全程指导、研审联动的方针，指导企业以临床价值为导向，提升产品研发的质量和效率。 通过设立突破性治疗药物、附条件批准、优先审评审批和特别批准4个通道，鼓励企业不断研发和申请创新药医疗产品。 杨霆表示，我国药品审评审批改革让企业能更清晰预判研发回报周期，专注源头创新，敢于投入高风险、长周期的创新药研发，形成创新药申 报数量和质量提升的良性循环。 杨霆介绍，通过改革试点，将200个工作日调整到了60个工作日，提前介入、提前服务。同时，将审评、检查和检验并联进行，给了企业极大 的方便。通过这种变化，企业的产品能够不断提升产品质量，对患者提供更好的保障，也鼓励企业产品能够走入国际市场。 我国新药好药呈现快速增长态势 央视网消息：国家药监局统计显示，我国上半年批准创新药43个，同比增长59%，接近2024年批准创新药48个的全年数量。新批准的创新药有 哪些突破和值得关注的药品？患者有哪些临床急需用药新选择？对药企有哪些利好政策？我国创新药行业的国际竞争力如何？ 国家药监局药品注册管理司司长杨霆介绍，创新药近年来持续获批上市数量增长，反映出从2018年以来，我国药品审评审批改 ...

Core Insights - The 2024 "Annual Report on Progress of New Drug Registration Clinical Trials in China" indicates a significant increase in drug clinical trial registrations, reaching 4,900, a year-on-year growth of 13.9% [2] - The report highlights that domestic pharmaceutical companies are actively engaged in clinical research, with 92.8% of the new trials initiated by domestic sponsors [2] Summary by Categories Overall Clinical Trial Registration - In 2024, the total number of drug clinical trial registrations in China reached 4,900, with new drug trials accounting for 2,539, representing 51.8% of the total [2] - The efficiency of clinical trial registration and implementation has improved compared to 2023, with average registration times for new drug trials reduced to 67.4 days [6] Drug Types and Categories - Chemical drugs dominate the clinical trials, making up over 70% of the total, while biological products account for 21.1% [4] - Among new drug trials, Class I registered drugs constitute 68.3%, with Phase I trials representing 46.92% of the total [4] Focus Areas in Clinical Trials - Antitumor drugs have the highest representation in clinical trials, with chemical drugs accounting for 24.7% and biological products for 43.1% [7] - The report indicates a notable increase in clinical trials for cell and gene therapies, with a growth rate exceeding 40% for newly registered trials [9][11] Pediatric and Rare Disease Drug Development - The number of clinical trials for pediatric and rare disease drugs has increased, with pediatric trials totaling 249, representing 9.8% of the new drug trials [14] - Rare disease drug trials reached 121, with a focus on blood system diseases, neurological diseases, and antitumor drugs, which together accounted for 63.6% of the total [16]

Core Viewpoint - China's pharmaceutical innovation is undergoing a historic transformation, driven by the collaboration of medical insurance, healthcare, and pharmaceutical sectors, aiming to shift from a "generic drug powerhouse" to an "innovative drug stronghold" [1] Group 1: Policy Measures - The National Healthcare Security Administration and the National Health Commission released measures to support high-quality development of innovative drugs, marking a significant step in China's healthcare strategy [1][2] - A series of policy documents were issued to establish a pricing negotiation process for innovative drugs, indicating a strategic arrangement for a multi-tiered medical security system [2] Group 2: Market Dynamics - In 2024, China's basic medical insurance fund had a total income of 34,809.95 billion yuan and total expenditure of 29,675.92 billion yuan, with commercial health insurance covering less than 8% of innovative drug costs [3] - The innovative drug market in China is projected to reach 1,620 billion yuan, highlighting the underutilization of commercial health insurance in supporting innovative drug development [3] Group 3: Insurance and Pharmaceutical Collaboration - The guidelines for the insurance directory focus on "clinical value-cost effectiveness," encouraging pharmaceutical companies to shift from "Me-too" to "First-in-class" drug development [4] - The establishment of a commercial health insurance directory for innovative drugs aims to alleviate the financial burden on basic medical insurance while providing new payment channels for innovative drugs [4][5] Group 4: Benefits of the New Framework - The new insurance directory benefits pharmaceutical companies by expanding patient access and accelerating capital recovery for further innovation [5] - Commercial insurance companies can leverage shared information from medical insurance to expand their health insurance business at lower costs, ultimately benefiting patients by reducing medical expenses [5] Group 5: Future Directions - The dynamic adjustment of the commercial health insurance directory and pricing mechanisms represents a process of balancing interests among various stakeholders, including patients, pharmaceutical companies, and insurance providers [6] - The integration of medical insurance and commercial health insurance is expected to evolve towards a collaborative regulatory framework, enhancing the overall healthcare system in China [8]

Core Insights - The "Two Zones" initiative in Beijing has achieved significant progress in institutional innovation, industrial development, and optimization of the business environment over the past five years, contributing to high-quality development in the capital [1][6]. Group 1: Institutional Innovation and Business Environment - Haidian District has provided valuable experiences for the national free trade zone through 98 institutional innovation cases, with 4 cases replicated nationwide and 9 cases promoted citywide, establishing a "Haidian Model" [3]. - The implementation of an "all-process online approval" model in Haidian has improved business efficiency by over 30% [3]. - Shunyi District has completed over 200 key tasks related to the "Two Zones" initiative and has formed 16 breakthrough policies and innovative models, achieving an online completion rate of over 95% for district-level approval matters [3][6]. Group 2: Industrial Development - The Yizhuang group has focused on high-end manufacturing and digital economy, achieving breakthroughs in data cross-border, biomedicine, artificial intelligence, and commercial aerospace [4]. - Changping District has developed a globally leading life science valley, with over 10 high-level research institutions and a total of 11 approved innovative drugs, contributing to a comprehensive industrial chain layout [5]. Group 3: Public Services and Talent Development - The Tianzhu Comprehensive Bonded Zone has seen a 95% year-on-year increase in the import of rare disease drugs, with an import value of 21.75 billion yuan, accounting for over 40% of the national total [6]. - Shunyi and Daxing districts are forming a synergistic development force in the biomedical field, enhancing public service systems and creating a talent innovation and entrepreneurship service system [6].

Investment Rating - The industry investment rating is "Outperform the Market," indicating an expected relative increase of over 10% in the industry index compared to the broader market within the next six months [5][8]. Core Insights - The National Medical Products Administration (NMPA) has reduced the review and approval time for clinical trial applications of eligible innovative drugs from 60 days to 30 days, aiming to accelerate the market entry of innovative drugs and shift domestic new drug development from "Fast-Follow" to "First-in-Class" [3]. - The focus of this policy includes pediatric drugs, rare diseases, and globally synchronized research products, with the NMPA encouraging the development of pediatric and rare disease medications through various incentives [3]. - Data from Yaozhi Network indicates that leukemia is the most common cancer among children, accounting for approximately 30% of all cases, while brain and spinal cord tumors account for about 25% [3]. - The overall trend shows that the domestic innovative drug review and approval policy has transitioned from "passive approval" to "active empowerment," enhancing the global competitiveness of domestic innovative drugs [3]. Summary by Sections Regulatory Changes - The draft proposal outlines that eligible innovative drugs must be either traditional Chinese medicine, chemical drugs, or biological products that meet specific criteria, including being supported by the state or included in special programs for children and rare diseases [2]. - Applications for eligible innovative drugs will be reviewed and approved within 30 working days [2]. Market Implications - The policy aims to facilitate early global synchronized research and international multi-center clinical trials for eligible innovative drugs [2]. - If a review cannot be completed within 30 days due to technical reasons, the NMPA will inform the applicant, and the subsequent timeline will follow a 60-day implied approval process [2]. Industry Performance - The report indicates that the pharmaceutical and biotechnology sector has shown a relative performance against the CSI 300 index, with a notable increase in the sector's attractiveness for investment [5][6].

作 者丨季媛媛 闫硕 编 辑丨黄剑 6月16日，国家药品监督管理局发布《关于优化创新药临床试验审评审批有关事项的公告（征 求意见稿）》（下称《征求意见稿》）， 一项可能重塑中国创新药研发格局的变革正拉开序 幕——核心创新药品种的临床试验审评审批周期有望压缩至30个工作日。 | 4 国家药品监督管理局 | 请输入关键字 | 无障碍 关怀版 中 En | | --- | --- | --- | | 2 National Medical Products Administration | | | | | | 6% ■8 | | 索引号 | FGWJ-2025-201 主题分类 | 法规文件 / 征求意见 | | --- | --- | --- | | 标题 | 国家药监局综合司公开征求《关于优化创新药临床试验审评审批有关事项的公告（征求意见稿）》意见 | | | 发布日期 | 2025-06-16 | | 创新研发"加速度" 药品审评作为一门科学，随着科技飞速发展，正通过一系列监管工具、标准与方法的创新，不 断制定和优化审评技术规范指南、检查检验评价技术及技术标准等，以有效解决影响药品创 新、质量、效率的突出问题。 ...

Core Viewpoint - The National Medical Products Administration (NMPA) has proposed a draft to optimize the clinical trial review and approval process for innovative drugs, potentially reducing the approval timeline to 30 working days, which could significantly enhance the efficiency of drug development in China [1][2]. Group 1: Approval Process Changes - The new draft aims to compress the clinical trial review and approval period for key innovative drugs to 30 working days, with some regions like Beijing potentially reducing it to 18 days [2]. - The draft supports the development of drugs that are classified as traditional Chinese medicine, chemical drugs, and biological products, specifically focusing on three categories: nationally supported innovative drugs, drugs for children and rare diseases, and globally synchronized research products [1][4]. Group 2: Impact on Drug Development - The reduction in approval time is expected to significantly improve the efficiency of clinical trial initiation, allowing companies to accelerate their research and capture global market opportunities [2]. - The new policy is anticipated to lower research and development costs and risks, reduce waiting times for companies, and ultimately enhance the international competitiveness of China's pharmaceutical industry [2][3]. Group 3: Focus on Rare Diseases and Children's Drugs - The draft emphasizes the inclusion of drugs for rare diseases and children's medications, addressing unmet clinical needs in these areas [6]. - Currently, only about 10% of the over 800 rare disease drugs available globally have been approved in China, indicating a substantial market opportunity for new drug development in this sector [6]. Group 4: Responsibilities and Compliance - The draft introduces a requirement for applicants to demonstrate their capability in risk assessment and management, ensuring that clinical trials can commence within 12 weeks post-approval [3][4]. - Companies must establish robust drug safety monitoring and risk control systems to align with the expedited review process, ensuring quality and safety standards are maintained [7][8]. Group 5: Global Collaboration and Market Positioning - The inclusion of global synchronized research in the priority review channel is expected to enhance China's attractiveness as a key site for international multi-center clinical trials [2][5]. - Domestic innovative pharmaceutical companies, such as BeiGene and Innovent Biologics, are likely to benefit from this new policy, as it allows them to expedite the development of their first-class new drugs that align with national support directions [5].

Group 1 - The core viewpoint of the articles highlights the significant improvements in logistics efficiency and trade facilitation in Beijing due to the "Two Zones" initiative, which has led to faster delivery times for fresh products and increased import values for pharmaceuticals [1][2][3] - Since the implementation of the "Two Zones" initiative, Beijing Customs has introduced over 20 innovative policies, enhancing the approval process for rare disease medications to a "minute-level" inspection and release time, resulting in a substantial increase in the import value of medical materials and drugs from 70 billion yuan in 2020 to 121.2 billion yuan in 2024 [1] - The number of inbound and outbound travelers monitored by Beijing Customs reached 8.99 million in the first five months of this year, a year-on-year increase of 22.8%, indicating a growing potential for inbound tourism consumption [2] Group 2 - The establishment of four comprehensive bonded zones in Beijing over the past five years has significantly boosted trade performance, with the Tianzhu Comprehensive Bonded Zone ranking second nationally in 2023 and achieving an import and export value exceeding 100 billion yuan [2] - The implementation of an integrated regulatory model at the Daxing Airport Comprehensive Bonded Zone has reduced transportation time for goods from one hour to ten minutes, enhancing operational efficiency [2] - Since the RCEP agreement came into effect in 2022, Beijing's trade with RCEP countries has surpassed 2 trillion yuan, reflecting closer regional economic cooperation and improved benefits for local foreign trade enterprises [3]