Chinese-Developed Drugs Are Increasingly Reaching International Markets, Study Finds

Medicines developed in China are increasingly winning approval in major international markets, particularly the United States, according to a study from King's Institute of Cancer Policy published in the journal eClinicalMedicine. The research provides a longitudinal assessment of international approvals of Chinese-developed drugs (CDDs) between 1990 and 2025, using the US as the primary reference market with additional comparisons to Europe and other regulatory jurisdictions.

The study identifies a clear shift in China's global pharmaceutical presence: earlier approvals were dominated by generic medicines and established therapeutic areas, but recent years have seen a rapid rise in innovative medicines, including small-molecule drugs and biologics, entering major markets. International approvals of Chinese-developed drugs increased markedly after 2015. In the US, Abbreviated New Drug Application (ANDA) approvals — generally covering generic drugs — reached 570 between 2016 and 2020 and 567 between 2021 and 2025, while New Drug Application (NDA) approvals, covering novel drugs, rose to 37 between 2021 and 2025.

By early 2025, the researchers report, China had approximately 7,032 to 7,041 active drug development projects underway, second only to the United States and accounting for nearly 29.5 percent of the global drug development pipeline. US approvals for Chinese-developed medicines have been particularly concentrated in oncology and immunology, reflecting growing international competitiveness in areas of high unmet clinical need. In Europe, Chinese innovative drugs and biosimilars — medicines containing a similar version of an already-approved drug's active substance — have also increasingly gained recognition from the European Medicines Agency (EMA).

The researchers say future growth in this area will depend on internationally focused clinical development, closer alignment between regulatory systems, and greater collaboration in multinational research and regulation.