
Since the State Council released the "Opinions on Reforming the Review and Approval System for Drugs and Medical Devices" ("Document 44") in 2015, China's innovative drug industry has undergone a profound strategic transformation and systematic restructuring, achieving a historic leap from being "dominated by generics" to "innovation-led." Over the past decade, driven by policy incentives, market demand, capital investment, and technological innovation, China has successfully built an innovative drug industry ecosystem that covers the entire chain of R&D, review, payment, and application.