Drugs developed in China reaching international markets, research finds

China has emerged as a significant player in pharmaceutical development, but its success in gaining approval for medicines in major international markets has received limited attention. A recent study published in eClinicalMedicine examines the international approval of Chinese-developed medicines from 1990 to 2025. The research, conducted by King's Institute of Cancer Policy in collaboration with Chinese researchers, provides insights into China's growing presence in the global pharmaceutical industry.

The study identifies a notable shift in China's pharmaceutical presence, with an increased focus on innovative medicines such as small-molecule drugs and biologics. Prior to 2015, approvals primarily consisted of generic medicines and established therapeutic areas. However, after 2015, there was a marked rise in international approvals, particularly for abbreviated New Drug Applications (ANDAs) and New Drug Applications (NDAs).

Between 2016 and 2020, ANDA approvals in the United States surged to 570, and this trend continued with 567 approvals between 2021 and 2025. NDAs also saw an increase, with 37 approvals recorded in the same period. By early 2025, China had approximately 7,032–7,041 active drug development projects, second only to the United States and accounting for nearly 29.5% of the global pipeline.

The research highlights a concentration of approvals in oncology and immunology, reflecting China's increasing competitiveness in these areas. These therapeutic areas are experiencing high unmet clinical needs, driving demand for innovative Chinese medicines. Cancer medicines have become a prominent focus of international expansion for China, including targeted therapies and immunotherapies.

In Europe, Chinese innovative drugs and high-quality biosimilars have gained recognition from the European Medicines Agency (EMA). The researchers suggest that future growth will depend on internationally focused clinical development, improved alignment between regulatory systems, and increased collaboration in multinational research and regulation.

The findings underscore China's growing influence in the global pharmaceutical landscape, with a shift from generic medicines to innovative products entering international markets. As China continues to develop its pharmaceutical capabilities, its impact on the global drug approval landscape is expected to grow.