King's College London has collaborated with colleagues in China to analyse the growing impact of China-developed drugs (CDDs) on the global pharmaceutical landscape.
China has become an increasingly important contributor to pharmaceutical development, but comparatively little attention has been paid to how successfully medicines developed in China have entered major international markets.
The study, published in eClinicalMedicine, provides a longitudinal assessment of the international approval of Chinese-developed medicines between 1990 and 2025. The United States was used as the primary reference market, with additional comparisons made with Europe and other regulatory jurisdictions. The study is part of a long-term collaboration between King's Institute of Cancer Policy and colleagues in China, particularly in the area of cancer medicines.
The research identifies a clear shift in China's global pharmaceutical presence. While earlier approvals were dominated by generic medicines and products in more established therapeutic areas, recent years have seen a rapid increase in innovative medicines, including small-molecule drugs and biologics entering major international markets.
International approvals of CDDs increased markedly after 2015. Abbreviated New Drug Application (ANDA) approvals rose sharply, reaching 570 between 2016 and 2020 and 567 between 2021 and 2025. New Drug Application (NDA) approvals also increased, with 37 approvals recorded between 2021 and 2025. The researchers report that by early 2025, China had approximately 7,032-7,041 active drug development projects, second only to the US and accounting for nearly 29.5% of the global pipeline.
The findings suggest that from around 2015, approval activity increased substantially, followed by continued growth in both the volume and complexity of applications over the following decade. In the US, ANDA approvals for medicines from China reached a sustained high-volume level after 2015.
The approvals have been particularly concentrated in oncology and immunology, reflecting the increasing international competitiveness of Chinese drug development in areas of high unmet clinical need. Cancer medicines have emerged as a particularly prominent area of international expansion, including targeted therapies and immunotherapies, while approvals in other therapeutic areas remain comparatively limited.
In Europe, Chinese innovative drugs and high-quality biosimilars, medicines that contain a similar version of the active substance in an approved medicine, have also increasingly gained recognition from the European Medicines Agency (EMA).
Our collaboration with Wuhan and Peking University has provided rich insights into China's growing importance not just to the global cancer medicines but also to wider pharmaceutical markets. This type of public policy collaboration provides the foundational public policy research to support better UK-China collaborations in this critical domain."
Professor Richard Sullivan, Director of the Institute of Cancer Policy
Our study shows a clear shift in the global footprint of Chinese pharmaceutical innovation. Approvals of Chinese-developed medicines in major international markets have accelerated markedly in recent years, signalling China's growing contribution to global drug development. The next challenge is to sustain this momentum, broaden it across therapeutic areas, and ensure that pharmaceutical innovation ultimately translates into meaningful benefits for patients worldwide."
Zhihao Xu, Dong Fureng Institute of Economic and Social Development, Wuhan University; Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, China
The researchers suggest future growth will depend on internationally focused clinical development, greater alignment between regulatory systems and increased collaboration in multinational research and regulation.
