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. 2020 Oct;17(10):589-590.
doi: 10.1038/s41571-020-0414-y.

Simultaneous development of zanubrutinib in the USA and China

Guanqiao Li  1 , Xiaozhen Liu  1 , Xiaoyuan Chen  2   3
Affiliations

Simultaneous development of zanubrutinib in the USA and China

Guanqiao Li et al. Nat Rev Clin Oncol. 2020 Oct.

Abstract

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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Conflict of interest statement

The authors declare no competing interests.

References

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