Trends and innovation analysis of new drug approvals in China and the United States from 2018 to 2023
ZHANG Dong
REN Feng
NIU Han-dong
CHEN Ai-ping
ZHANG Jing-chen
Abstract：This study systematically sorts out the data on innovative drugs approved for marketing entry in China and the United States from 2018 to 2023.It compares the R&D trends and differences in terms of drug types,target distributions,technological roadmaps,therapeutic areas.The findings reveal the bottlenecks and driving forces behind China's transition from"pursuant layout"to"original innovation"in its innovative pharmaceutical sector.Data show that the gap between China and the United States in the approval number of innovative drugs is narrowing year by year,while the comprehensiveness of technologies is increasing yearly.In the future,domestic innovative drugs may achieve breakthroughs in areas like radiopharmaceuticals,small nucleic acid drugs,and innovative biological products.The approval trends and innovation analysis data show that,in recent years,the state's investment in pharmaceutical research and development has been increasing continuously,which has cultivated a large number of pharmaceutical R&D and regulatory talents,promoted the breakthrough reform of regulatory science,and the improvement of industrial innovation capabilities in the whole chain.It is expected to promote the high-quality development of China's pharmaceutical industry in an all-round way by strengthening basic research,connecting the entire process of"clinical demand-basic research-commercialization",developing new regulatory tools,and accelerating the development of new quality productive forces.
Keywords：innovative drugsregistration applicationdrug discoveryindustry managementtechnological innovation
Publication Date：2025-07-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：11( 1373-1383 )