中金 | 深度布局“十五五”：医药生物篇

Core Viewpoint - The article emphasizes the acceleration of innovation in the pharmaceutical and medical device industries in China, driven by supportive policies and a shift from generic to innovative drug development, which is expected to enhance the industry's quality and global competitiveness [2][3][5]. Policy Support for Innovation - Since 2020, numerous favorable policies have been introduced to improve the ecosystem for innovative drugs, focusing on research standards, review and approval systems, patent protection, and reimbursement mechanisms [2]. - The "14th Five-Year Plan" highlights the importance of supporting innovative drugs and medical devices, indicating their critical role in national health and economic development [3][5]. Clinical Trials and Market Dynamics - The number of clinical trials for innovative drugs in China has surpassed 1,900, outpacing the US, Europe, and Japan, reflecting a significant increase in research quality and efficiency [3][8]. - By 2024, 39 innovative drugs approved for the first time in China were domestically developed, increasing from 31% in 2020 to 42% in 2024, indicating a strong trend towards domestic innovation [3][5]. Medical Insurance and Payment Systems - The narrowing surplus of the national medical insurance fund has created a mismatch between the commercialization of innovative drugs and their approval timelines, necessitating improvements in the commercial insurance system [8][27]. - The "15th Five-Year Plan" aims to establish a multi-tiered medical insurance system, which is expected to enhance the role of commercial health insurance in providing payment support for innovative drugs [27][32]. Medical Devices and Technological Innovation - The approval of innovative medical devices has increased by 43% from 2016-2020 to 2021-2024, driven by improved regulatory mechanisms and support for high-end medical device innovation [10][13]. - The article notes that while domestic brands are gaining global competitiveness, the industry still faces challenges in achieving systematic original innovation and key technology breakthroughs [13][19]. Emerging Technologies - The application of AI and brain-machine interfaces in healthcare is progressing towards industrialization, with the establishment of preliminary frameworks for clinical applications and payment rules [14][18]. - The integration of high-quality data flow in healthcare is anticipated to enhance the clinical benefits of new technologies, improving resource utilization and patient outcomes [18][19]. Biomanufacturing Developments - The biomanufacturing sector in China is transitioning from a "follower" to a "runner" stage, with significant advancements in technology and policy support, laying a solid foundation for future growth [19][20]. - The article highlights the importance of focusing on high-value, environmentally friendly products, such as biodegradable materials, to expand market opportunities [22][26].