《条例》提出，支持以临床价值为导向的药品研制和创新，鼓励研究和创制新药，支持新药临床推广和 使用。明确药物非临床安全性评价研究机构资格认定程序，细化药物临床试验管理要求。设立药品上市 注册加快程序，明确药品再注册程序，规定处方药、非处方药转换机制。对符合条件的儿童用药品、罕 见病治疗用药品给予市场独占期，对含有新型化学成分的药品等进行数据保护。细化药品上市许可持有 人的责任。 《条例》强调，加强药品生产管理。严格药品委托生产管理，压实委托生产时药品上市许可持有人的责 任，明确可以委托分段生产药品的情形。明确中药饮片、中药配方颗粒生产、销售的管理要求。 《条例》要求，完善药品网络销售管理制度，压实药品网络交易第三方平台提供者责任。加强医疗机构 药事管理，保障使用环节药品质量。明确医疗机构配制制剂审批流程，规定医疗机构制剂调剂使用条件 和程序，支持配制儿童用医疗机构制剂，满足儿童患者用药需求。 中证报中证网讯(记者傅苏颖)日前，新修订的《中华人民共和国药品管理法实施条例》(简称《条例》) 发布，自2026年5月15日起施行。 张伟表示，展望未来，随着《条例》的深入实施，将进一步提升我国药品审评审批的质量和效率，加 ...

Core Insights - China has achieved record highs in the number of approved innovative drugs and total external licensing transactions, with approximately 30% of global drug pipelines being in development in China [2][4] - The National Medical Products Administration (NMPA) aims to continue promoting innovative drugs with new mechanisms and targets, supported by institutional backing and improvements in the payment system for innovative drugs [2][6] Group 1: Innovative Drug Approvals - In 2025, China approved 76 innovative drugs, significantly surpassing the 48 approved in 2024, marking a historical high [2] - Among the approved drugs, domestic products accounted for over 85%, with 80.85% of chemical drugs and 91.30% of biological products being domestically developed [3][2] - The number of first-in-class innovative drugs approved in China reached 11, with 4 being independently developed in China [4] Group 2: External Licensing Transactions - The total amount for external licensing transactions of innovative drugs in China exceeded $130 billion in 2025, with over 150 transactions, doubling from the previous year [6] - This growth reflects international recognition of the value of Chinese innovative drugs and is supported by ongoing reforms in drug review and approval processes [6][8] Group 3: R&D Pipeline and Quality - China's R&D pipeline now accounts for about 30% of the global total, a significant increase from just 4% a decade ago [4] - The quality of domestic drug development has improved, with contributions to early clinical pipelines for next-generation therapies like ADCs and bispecific/trispecific antibodies nearing or exceeding 50% globally [4] Group 4: Policy and Market Dynamics - The NMPA plans to enhance support for urgently needed drugs and improve the regulatory framework for drug trials and market exclusivity [7][8] - The introduction of the commercial insurance innovative drug directory is expected to facilitate access to high-priced innovative drugs, potentially boosting market sales [9] - The Chinese innovative drug market is projected to grow significantly, with estimates suggesting a market size of approximately 740 billion RMB in 2025 and a compound annual growth rate of 24.1% from 2024 to 2030 [10]

Core Viewpoint - In the past year, China has achieved record highs in the number of approved innovative drugs and total external licensing transactions, with approximately 30% of global drug pipelines currently under research in China. The National Medical Products Administration (NMPA) will continue to promote resources towards innovative drugs with new mechanisms and targets, while institutional support for biopharmaceutical innovation is expected to improve the domestic payment system for innovative drugs [3][4][6]. Group 1: Innovative Drug Approvals - In 2025, China approved 76 innovative drugs, significantly surpassing the 48 approved in 2024, marking a historical high [3]. - Among the approved innovative drugs, domestic drugs accounted for over 85%, with 80.85% of chemical drugs and 91.30% of biological products being domestically developed [4][5]. - The quality of domestic drug development has improved, with China contributing nearly 50% to global early clinical pipelines for next-generation therapies like ADCs and bispecific/trispecific antibodies [5]. Group 2: Licensing Transactions - In 2025, the total amount of external licensing transactions for Chinese innovative drugs exceeded $130 billion, with over 150 transactions, doubling the previous year's total of $51.9 billion [6]. - The significant increase in licensing reflects international recognition of the value of Chinese innovative drugs, supported by ongoing reforms in drug review and approval processes [6][7]. Group 3: Policy and Market Environment - The NMPA plans to enhance support for urgently needed clinical drugs through expedited review channels and improve the protection of drug trial data and market exclusivity [7]. - The new foreign investment encouragement policy in the pharmaceutical sector signals China's openness to foreign capital in drug innovation, particularly in new target and mechanism development [8]. - Despite advancements, the market mechanisms for innovative drugs in China still require improvement, with current innovative drug market share at only 8.6% compared to 81.8% in the U.S., indicating a need for better payment and pricing structures [8][9]. Group 4: Market Growth Projections - A report predicts that the Chinese innovative drug market will reach approximately 550 billion RMB in 2024, growing to over 740 billion RMB in 2025, with a compound annual growth rate of 24.1% expected from 2024 to 2030 [10].

Core Insights - In 2025, China approved a record 76 innovative drugs, significantly surpassing the 48 approved in 2024, marking a historic high for the country [1][2] - The total value of innovative drug licensing transactions from China exceeded $130 billion in 2025, with over 150 transactions, also a record high [1][4] - Domestic innovative drugs accounted for over 85% of the newly approved drugs in 2025, indicating a strong growth in local pharmaceutical development [2][3] Group 1: Drug Approval and Market Dynamics - The National Medical Products Administration (NMPA) reported that 38 out of 47 chemical drugs approved in 2025 were domestically developed, representing 80.85% of the total [1] - Among the 23 biological products approved, 21 were domestic, accounting for 91.30% [1] - The number of innovative drugs in the pipeline in China represents approximately 30% of the global total, positioning China as the second-largest contributor worldwide [2] Group 2: International Recognition and Investment - The significant increase in licensing transactions reflects international recognition of the value of Chinese innovative drugs, with the total transaction amount doubling from the previous year [4] - The NMPA is committed to enhancing the approval process for urgently needed drugs, particularly those with new mechanisms and targets, to further stimulate innovation [5] - New policies encouraging foreign investment in the pharmaceutical sector signal China's openness to global capital in drug innovation [5] Group 3: Market Growth and Future Projections - The Chinese innovative drug market is projected to reach approximately 740 billion RMB in 2025, with an overall growth rate of about 35% [7] - By 2030, the market size is expected to exceed 2 trillion RMB, with a compound annual growth rate of 24.1% from 2024 to 2030 [7] - The introduction of the commercial insurance innovative drug directory is anticipated to enhance market access for high-priced innovative drugs, potentially increasing sales [6]

Core Insights - In 2025, China approved a record 76 innovative drugs, significantly surpassing the 48 approved in 2024, marking a historical high [1] - The total value of innovative drug licensing transactions in 2025 exceeded $130 billion, with over 150 transactions, also a historical high [2] - The increase in innovative drug approvals and licensing reflects China's progress in drug evaluation reforms and the international recognition of the value of its innovative drugs [2] Summary by Sections Innovative Drug Approvals - In 2025, 76 innovative drugs were approved, including 47 chemical drugs, 23 biological products, and 6 traditional Chinese medicines [1] - Among the 47 chemical drugs, 38 were domestically developed, representing 80.85% of the total [1] - For the 23 biological products, 21 were domestically developed, accounting for 91.30% [1] - 11 first-in-class innovative drugs were approved, with 4 being independently developed in China [1] Licensing Transactions - The total licensing transaction amount for innovative drugs in 2025 was over $130 billion, nearly doubling from $51.9 billion in 2024 [2] - The number of licensing transactions increased to over 150, compared to 94 in 2024 [2] - China's pipeline of new drugs accounts for approximately 30% of the global total, ranking second worldwide [2] Future Initiatives - Starting in 2026, the National Medical Products Administration (NMPA) will implement more measures to accelerate the development of innovative drugs [3] - There will be a focus on prioritizing review resources for urgently needed clinical products, especially those with new mechanisms and targets [3] - The NMPA plans to enhance support through breakthrough therapy designations, conditional approvals, and priority reviews to expedite the market entry of critical drugs [3]

记者从国家药监局还获悉，2025年我国创新药对外授权交易总金额超过1300亿美元，授权交易数量超过 150笔，远超2024年全年519亿美元和94笔，同样创历史新高。我国在研新药管线约占全球30%，位列全 球第二。 国家药监局药品注册管理司副司长蓝恭涛：2025年我国创新药对外授权交易总额较上一年翻了大约一 倍，创新药审批数量也创新高，这是我国持续深化药品审评审批制度改革，一系列鼓励创新政策落地实 施的重大成果。在创新药数量增长的同时，我们坚持标准不降低、标准国际化，对外授权的大幅增长也 反映出国际社会对我国创新药价值的认可。 国家药监局表示，从2026年开始，国家药监局将出台更多举措，助推我国创新药高速发展。 记者今天从国家药监局获悉，2025年我国已批准上市的创新药达76个，大幅超过2024年全年48个，创历 史新高。此外，2025年我国创新药对外授权交易总金额超过1300亿美元，授权交易数量超过150笔，同 样创历史新高。 据了解，2025年国家药监局批准上市的76个创新药，包括47个化学药品、23个生物制品和6个中药。47 个化学药品中，38个为国产创新药，9个为进口创新药，国产创新药占比达80.85 ...

Core Insights - China has transitioned from being a low-cost supplier of raw materials in the global pharmaceutical industry to becoming a significant source of drug innovation [1][2] - The "14th Five-Year Plan" emphasizes support for the development of innovative drugs and medical devices, indicating a robust growth trajectory for China's pharmaceutical industry [1] - Recent reforms in drug review and approval processes have accelerated the innovation and market entry of new drugs, with average review times significantly reduced [1][2] Group 1: Drug Innovation and Approval - The National Medical Products Administration (NMPA) has established expedited pathways for innovative drugs, including breakthrough therapy designations and priority reviews, resulting in an average review time of 225 working days for innovative drug applications in 2024 [1] - The average review time for priority-reviewed innovative drugs is only 162 working days, showcasing a marked improvement in approval speed [1] - The NMPA's support for clinical value-oriented drug innovation is evident through the establishment of various fast-track approval channels [1] Group 2: Medical Device Innovation - In November, the NMPA approved three innovative medical devices, reflecting a commitment to enhancing the regulatory framework for high-end medical devices [2] - The NMPA's 2025 announcement outlines ten measures to support the innovation of high-end medical devices, including optimizing special approval processes and improving standard systems [2] - China's drug review technical requirements are now fully aligned with international standards, allowing for synchronized drug submissions both domestically and internationally [2] Group 3: Market Dynamics and International Collaboration - The Chinese pharmaceutical market has grown to become the second largest in the world, attracting increased investment and interest from foreign pharmaceutical companies [3] - Despite the growth, there is a noted lack of original innovative drugs with new targets and mechanisms, indicating a need for enhanced foundational research and core technology development [3] - The NMPA emphasizes the importance of a collaborative approach among various sectors to boost original innovation capabilities in the biopharmaceutical industry [3]

Group 1: Industry Transformation - China has transitioned from being viewed as a low-cost supplier of raw materials in the global pharmaceutical industry to becoming a significant source of drug innovation [1] - The "14th Five-Year Plan" emphasizes support for the development of innovative drugs and medical devices, indicating a robust growth trajectory for China's pharmaceutical industry with enhanced innovation and global competitiveness [1] - The National Medical Products Administration (NMPA) has implemented reforms to accelerate drug review and approval processes, establishing mechanisms to expedite the market entry of innovative drugs [1] Group 2: Regulatory Support and Innovation - The NMPA has introduced four expedited pathways for drug approval, including breakthrough therapy designation and priority review, significantly reducing the average review time for innovative drugs [1] - In 2024, the average review time for innovative drug applications is projected to be 225 working days, with priority-reviewed drugs taking only 162 working days [1] - Recent approvals of innovative medical devices, such as single-use pressure monitoring catheters and aortic stent systems, reflect the NMPA's commitment to supporting high-end medical device innovation [2] Group 3: Global Market Engagement - China's pharmaceutical industry has become the second-largest market globally, attracting increased investment and interest from foreign pharmaceutical companies [3] - The country is now participating in the global launch of new drugs, with examples like the global first launch of certain monoclonal antibodies in China, allowing local patients to access the latest treatments sooner [2] - Despite progress, there is a recognition of the need for more original innovative drugs and foundational research in the life sciences to enhance China's source innovation capabilities [3]

Core Insights - The article highlights the significant achievements of China in the field of new drug development, attributing these successes to the 2015 reform of the drug review and approval system, which has integrated China's clinical research into global multi-center studies [1] - The 2025 European Society for Medical Oncology (ESMO) conference showcased numerous Chinese experts and their research, indicating a growing international collaboration and interest in Chinese innovative pharmaceuticals [1] - The 2025 Sino-European Academic Forum on Thoracic Diseases emphasizes the importance of cross-cultural collaboration and the sharing of clinical practices and innovations between China and Europe [2] Group 1: Drug Development and Innovation - The 2015 drug policy reform has been pivotal in enhancing China's capabilities in clinical research and drug development, leading to significant advancements in treatment options for various diseases [1] - Chinese innovative pharmaceutical companies are increasingly engaging in international licensing collaborations, with high-quality data disclosure being a critical foundation for these partnerships [1] Group 2: Academic Forum Highlights - The 2025 Sino-European Academic Forum focuses on three main themes: local innovation and clinical practice, global advancements and technological breakthroughs, and cross-cultural collaboration in future medicine [2] - Prominent Chinese scholars presented on topics such as vascular disease treatment strategies and precision lung cancer therapy, showcasing China's achievements in clinical practice and research translation [2] Group 3: Clinical Practices and Technologies - The forum included discussions on the differences in lung cancer early screening practices between China and European countries, highlighting China's proactive approach in early diagnosis [5] - The use of surgical robots in thoracic surgery was emphasized as a means to enhance precision and reduce complications, with potential for remote medical applications and AI-driven surgical procedures in the future [6] - The integration of traditional Chinese medicine with modern oncology practices was explored, focusing on improving patient quality of life and addressing adverse reactions to targeted therapies [6]

Core Insights - The National Medical Products Administration (NMPA) has approved 210 innovative drugs and 269 innovative medical devices during the 14th Five-Year Plan period, indicating a sustained acceleration in growth [1][2][4] - China's biopharmaceutical market has become the second largest globally, with approximately 30% of the world's innovative drugs under development, reflecting increasing global recognition of Chinese innovative drugs [1][2][5] - The industry is witnessing a significant improvement in supply-demand dynamics, driven by innovation as a core growth engine, presenting potential investment opportunities [1][2][7] Regulatory and Approval Processes - The NMPA has established priority review and approval channels for key products, enhancing support for innovative drug and device development [2][4] - The approval time for supplementary applications has been reduced from 200 working days to 60 days, and for innovative drug clinical trial reviews from 60 days to 30 days [4][10] - A total of 394 pediatric drugs and 147 rare disease drugs have been approved since the beginning of the 14th Five-Year Plan, addressing critical medication needs [3] Company Performance and R&D Investment - Heng Rui Medicine reported a revenue of 15.76 billion yuan in the first half of 2025, a year-on-year increase of 15.88%, with innovative drug sales contributing 60.66% of total revenue [5] - Fosun Pharma achieved a revenue of 19.51 billion yuan, with innovative drug revenue exceeding 4.3 billion yuan, reflecting a 14.26% year-on-year growth [6] - United Imaging Healthcare reported a revenue of 6.02 billion yuan, a 12.79% increase, with R&D investment reaching 1.14 billion yuan [7] Internationalization and Market Expansion - Chinese innovative drugs are increasingly entering international markets, with companies like Fosun Pharma engaging in licensing agreements to expand their global footprint [8][9] - The demand for breakthrough therapies in Western markets is driving the internationalization of Chinese pharmaceutical companies, enhancing their competitiveness [9] - The NMPA is committed to promoting the internationalization of drug regulation and facilitating the export of Chinese pharmaceuticals [9][10] Technological Advancements - The industry is experiencing a wave of disruptive technologies, including CRISPR gene editing and mRNA therapies, which are enhancing China's role in global biopharmaceutical innovation [7][9] - The NMPA is focusing on high-end medical devices and innovative technologies, such as brain-computer interfaces and new radiation therapy equipment, to support the development of the medical device sector [10]