International approval of Chinese pharmaceuticals: a USA-anchored analysis with comparative insights from Europe and other markets.

Authors

Zhihao Xu, Kristina Jenei, Richard Sullivan

Published in

EClinicalMedicine. Volume 98. Pages 104121. Epub Aug 06, 2026.

Abstract

China-developed drugs (CDDs) have become increasingly visible in global pharmaceutical development, yet their long-term international approval trajectory remains insufficiently characterised. This study examined the evolution of CDD approvals across major regulatory markets from 1990 to 2025, using the USA as the primary analytical anchor and Europe and other international markets as comparative and contextual settings.
We conducted a retrospective longitudinal descriptive study using regulatory approval records from the MENET database, supplemented by publicly available regulatory information. US Food and Drug Administration approvals were analysed at the approval-event level across Abbreviated New Drug Applications, New Drug Applications, and Biologics Licence Applications. European Medicines Agency (EMA) approvals were assessed at the product level, and approvals in other markets were summarised descriptively to characterise geographic diffusion. Therapeutic areas were classified using the Anatomical Therapeutic Chemical system.
International approvals of CDDs increased markedly after 2015. In the USA, early approvals were sparse and dominated by generic-drug pathways, whereas Abbreviated New Drug Application approvals rose sharply to 570 in 2016-2020 and 567 in 2021-2025. New Drug Application approvals accelerated in 2021-2025, with 37 approvals in this period, while Biologics Licence Application approvals first appeared in 2022 and clustered after 2023. The post-2015 portfolio shifted toward antineoplastic and immunomodulating agents, cardiovascular drugs, and nervous system drugs. EMA approvals remained fewer but were concentrated in oncology, immunology, biologics, biosimilars, and advanced therapies. Several CDDs, particularly oncology and immunology products, achieved sequential or simultaneous approvals across the USA, Europe, the UK, Japan, Australia, Canada, and other markets.
The internationalisation of CDDs has progressed from sporadic, manufacturing-led generic approvals to broader participation across innovative small molecules, biologics, biosimilars, and advanced therapies. This transition suggests increasing regulatory maturity and global development capacity among selected Chinese pharmaceutical firms. However, international approvals remain therapeutically concentrated, especially in oncology and immunology, underscoring the need for broader therapeutic diversification and stronger evidence on the determinants of global diffusion.
None.

PMID:
42602923
Bibliographic data and abstract were imported from PubMed on 15 Aug 2026.

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