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Simultaneous development of zanubrutinib in the USA and China

Nature Reviews Clinical Oncology volume 17, pages 589–590 (2020)Cite this article

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Zanubrutinib was recently granted expedited approval by the USA and Chinese drug regulatory authorities for the treatment of mantle cell lymphoma, thus becoming the first investigational new drug discovered in China to achieve simultaneous development in both countries. Here, we provide an overview of the regulatory processes and considerations of the two health authorities and discuss the pathways of concurrent review and approval.

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Acknowledgements

We gratefully acknowledge extensive contributions of Yi-long Wu (Guangdong General Hospital), Ling Su (Shenyang Pharmaceutical University), Yangzhong Zhou (Peking Union Medical College Hospital), Ning Zhang and Lianjie Ren (Chinese Center for Drug Evaluation (CDE)) and Zili Li (Janssen Research & Development) for discussions relating to the composition and content of this manuscript. We are also grateful to Pharmcube (Beijing) for providing the public data on zanubrutinib.

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Authors and Affiliations

  1. Tsinghua Clinical Research Institute (TCRI), School of Medicine, Tsinghua University, Beijing, China

    Guanqiao Li, Xiaozhen Liu & Xiaoyuan Chen

  2. Office of Clinical Trial Institute, Beijing Tsinghua Changguang Hospital, Beijing, China

    Xiaoyuan Chen

Authors
  1. Guanqiao Li
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  2. Xiaozhen Liu
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  3. Xiaoyuan Chen
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Correspondence to Xiaoyuan Chen.

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The authors declare no competing interests.

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Related links

Chinese Drug Registration Regulations: http://www.nmpa.gov.cn/WS04/CL2077/376150.html

Project Orbis: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis

Real-Time Oncology Review: https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program

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Li, G., Liu, X. & Chen, X. Simultaneous development of zanubrutinib in the USA and China. Nat Rev Clin Oncol 17, 589–590 (2020). https://doi.org/10.1038/s41571-020-0414-y

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