Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Comment
  • Published:

Newly approved cancer drugs in China — innovation and clinical benefit

Around 100 new cancer drugs, defined as new molecular entities, were approved in China between 2005 and 2021. More than half of these new cancer drugs do not constitute innovations in mechanism of action or therapy and do not have documented meaningful clinical benefit. Approaches are needed to promote meaningful innovation for patients with cancer.

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

References

  1. Kesselheim, A. S. & Avorn, J. The most transformative drugs of the past 25 years: a survey of physicians. Nat. Rev. Drug Discov. 12, 425–431 (2013).

    Article  CAS  PubMed  Google Scholar 

  2. Center for Drug Evaluation. National Medical Products Administration. Annual Drug Evaluation Report https://www.cde.org.cn/main/news/viewInfoCommon/f92b7bdf775bbf4c4dc3a762f343cdc8 (2021).

  3. Zhang, Y. et al. Overall survival benefits of cancer drugs approved in China from 2005 to 2020. JAMA Netw. Open 5, e2225973 (2022).

    Article  PubMed  PubMed Central  Google Scholar 

  4. Li, G., Qin, Y., Xie, C., Wu, Y. L. & Chen, X. Trends in oncology drug innovation in China. Nat. Rev. Drug Discov. 20, 15–16 (2021).

    Article  PubMed  Google Scholar 

  5. Kesselheim, A. S., Wang, B. & Avorn, J. Defining “innovativeness” in drug development: a systematic review. Clin. Pharmacol. Ther. 94, 336–348 (2013).

    Article  CAS  PubMed  Google Scholar 

  6. Aronson, J. K., Ferner, R. E. & Hughes, D. A. Defining rewardable innovation in drug therapy. Nat. Rev. Drug Discov. 11, 253–254 (2012).

    Article  CAS  PubMed  Google Scholar 

  7. Olivier, T., Haslam, A. & Prasad, V. Anticancer drugs approved by the US Food and Drug Administration from 2009 to 2020 according to their mechanism of action. JAMA Netw. Open 4, e2138793 (2021).

    Article  PubMed  PubMed Central  Google Scholar 

  8. Hwang, T. J., Ross, J. S., Vokinger, K. N. & Kesselheim, A. S. Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study. BMJ 371, m3434 (2020).

    Article  PubMed  PubMed Central  Google Scholar 

  9. Naci, H., Carter, A. W. & Mossialos, E. Why the drug development pipeline is not delivering better medicines. BMJ 351, h5542 (2015).

    Article  PubMed  Google Scholar 

  10. Fojo, T., Mailankody, S. & Lo, A. Unintended consequences of expensive cancer therapeutics — the pursuit of marginal indications and a me-too mentality that stifles innovation and creativity: the John Conley Lecture. JAMA Otolaryngol. Head Neck Surg. 140, 1225–1236 (2014).

    Article  PubMed  Google Scholar 

  11. Munos, B. Lessons from 60 years of pharmaceutical innovation. Nat. Rev. Drug Discov. 8, 959–968 (2009).

    Article  CAS  PubMed  Google Scholar 

  12. Center for Drug Evaluation. National Medical Products Administration. Guidance on Clinical Value-Oriented Oncology Drug Research and Development https://www.cde.org.cn/main/news/viewInfoCommon/ef7bfde96c769308ad080bb7ab2f538e (2021).

  13. Liu, A. Is China’s drug regulator suddenly raising the bar on cancer med R&D? Not exactly, say experts. Fierce Pharma https://www.fiercepharma.com/pharma-asia/china-s-drug-regulator-suddenly-raising-bar-cancer-med-r-d-not-exactly-say-experts (2021).

  14. National Medical Products Administration. Regulations for the Implementation of the Drug Administration Law (Draft) https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20220509220456183.html (2022).

Download references

Acknowledgements

The authors thank H. Naci and L. Shi for insightful review and comments on this work, and Y. Li for assistance with data processing. X.G. gratefully acknowledges grants from Research on Equitable Access and Rational Use of Medicines sponsored by Peking University Health Science Center. The funding organization had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. No other disclosures were reported.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Xiaodong Guan.

Ethics declarations

Competing interests

The authors declare no competing interests.

Supplementary information

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Zhang, Y., Wagner, A.K. & Guan, X. Newly approved cancer drugs in China — innovation and clinical benefit. Nat Rev Clin Oncol 20, 135–136 (2023). https://doi.org/10.1038/s41571-023-00728-3

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41571-023-00728-3

This article is cited by

Search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing