Abstract:

 Objective： To systematically analyze the marketing approval status of biological products in China from 2009 to 2024， summarize innovation characteristics， policy effects， and existing problems， and provide a basis for optimizing regulatory strategies.Methods： Based on publicly available data from the Center for Drug Evaluation （CDE） of the National Medical Products Administration （NMPA）， 1474 approved drugs （including 583 biological products） were classified and statistically analyzed， with a focus on 535 therapeutic biological products in terms of mechanism type， innovation level， therapeutic areas， and approval pathways.Results： In the field of therapeutic biological products， antibody drugs dominated （322 cases， 60.2%）， while cell therapy products only 4 cases （0.7%）， showing a significant disparity. Analysis of innovation levels revealed 66 innovative therapeutic biological products （12.3%）， 72 improved products （13.5%）， and 37 biosimilars （6.9%）. Notably， after the implementation of the revised Provisions for Drug Registration in 2020， the proportion of priority reviews significantly increased， with anti-tumor drugs being the primary beneficiaries （198 cases， 37%）. Geographically， applicant enterprises were highly concentrated in the Yangtze River Delta and Pearl River Delta regions. The top five regions in terms of the number of therapeutic biological product applications were Shanghai （237 cases）， Beijing （90 cases）， Jiangsu （51 cases）， Guangdong （31 cases）， and Zhejiang （22 cases）， collectively accounting for 80.4% of the total， indicating significant regional agglomeration. In terms of enterprise distribution， multinational pharmaceutical companies dominated.Conclusion： China's review efficiency for biological products has significantly improved， but challenges remain in original innovation capacity and structural balance. It is necessary to strengthen support for cutting-edge fields such as cell therapy and improve mechanisms for balanced regional development.

Key words: Biological products； , Marketing authorization application； , Innovative drugs； , Priority review； , Regulatory science