企业研发投入结硕果“十四五”药械创新双提速

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]