今年上半年，我国新药完成81笔对外授权交易，合同潜在总金额约1100亿美元，超过2025年全年的80%，是2024年全年的两倍多 [1]。2025年批准的新药中，国产新药占65个，占比超过85% [1]。其中，7月国家药监局批准了全球首个选择性食欲素2型受体激动剂上市，用于治疗16岁及以上青少年和成人1型发作性睡病 [1]。
国产新药在创新能力方面取得突破性进展。2025年批准的新药中有11个属于新靶点、新机制药物，其中4个为国内企业自主研发；2026年上半年批准的38个新药中11个新靶点、新机制药物全部为国产药 [1]。多款原创靶点、新机制罕见病治疗药物实现了全球首报首发 [1]。迪哲医药将自主研发新药的全球范围内独家开发与商业化权利授予阿斯利康，首付款达6亿美元 [1]。
这一成就得益于产业持续加大研发投入和药审制度改革。恒瑞医药研发投入占营收比从2015年的约19%提升到2025年的近30%，已在国内获批上市25款一类新药和5款二类新药 [1]。我国在研新药管线约占全球总量的30%，稳居全球第二 [1]。同时，新药临床试验审批从14个月压缩至30日 [1]，审批效率的提升为新药研发提供了有力支撑。
China's domestic pharmaceutical sector achieved unprecedented success in drug licensing and development this year. In the first half of 2026, Chinese companies completed 81 overseas licensing transactions with a combined potential value of approximately 1.1 billion US dollars, exceeding 80 percent of the entire 2025 annual total and more than double the full-year 2024 figure.[1] Among drugs approved in 2025, domestic pharmaceutical products accounted for 65 of the total approvals, representing over 85 percent of new drugs granted market authorization.[1]
The sector is experiencing simultaneous growth in both quantity and quality of innovation. Of the 11 drugs with novel targets or mechanisms of action approved in 2025, four were independently developed by domestic enterprises.[1] This trend continued into the first half of 2026, when all 11 drugs with new targets or mechanisms among the 38 newly approved medications were domestically produced.[1] In July, China's drug regulatory authority approved the world's first selective orexin 2 receptor agonist for market use, indicated for treating narcolepsy type 1 in adolescents and adults aged 16 and above.[1]
Chinese pharmaceutical companies are intensifying investment in research and development to fuel this innovation pipeline. Hengrui Pharmaceuticals increased its research and development spending as a proportion of revenue from approximately 19 percent in 2015 to nearly 30 percent in 2025, and has brought 25 first-category and five second-category innovative drugs to market domestically.[1] Dizhe Pharmaceuticals demonstrated growing international confidence in Chinese innovation by granting AstraZeneca exclusive global development and commercialization rights for its independently developed drug, with an upfront payment of 600 million US dollars.[1] China currently maintains the world's second-largest pipeline of drugs under development, accounting for approximately 30 percent of the global total.[1] Regulatory reforms have accelerated the development timeline, with clinical trial approval processing compressed from 14 months to 30 days.[1]