Guanqiao Li, Xiaozheng Liu, Xiaoyuan Chen
Jul 10, 2020
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Influential Citations
16
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Journal
Nature Reviews. Clinical Oncology
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.