Simultaneous development of zanubrutinib in the USA and China

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...

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Detalles Bibliográficos
Autores principales: Li, Guanqiao, Liu, Xiaozhen, Chen, Xiaoyuan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2020
Materias:
Comment
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7351534/
https://www.ncbi.nlm.nih.gov/pubmed/32651571
http://dx.doi.org/10.1038/s41571-020-0414-y
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author Li, Guanqiao
Liu, Xiaozhen
Chen, Xiaoyuan
author_facet Li, Guanqiao
Liu, Xiaozhen
Chen, Xiaoyuan
author_sort Li, Guanqiao
collection PubMed
description 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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spelling pubmed-73515342020-07-13 Simultaneous development of zanubrutinib in the USA and China Li, Guanqiao Liu, Xiaozhen Chen, Xiaoyuan Nat Rev Clin Oncol Comment 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. Nature Publishing Group UK 2020-07-10 2020 /pmc/articles/PMC7351534/ /pubmed/32651571 http://dx.doi.org/10.1038/s41571-020-0414-y Text en © Springer Nature Limited 2020 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Comment
Li, Guanqiao
Liu, Xiaozhen
Chen, Xiaoyuan
Simultaneous development of zanubrutinib in the USA and China
title Simultaneous development of zanubrutinib in the USA and China
title_full Simultaneous development of zanubrutinib in the USA and China
title_fullStr Simultaneous development of zanubrutinib in the USA and China
title_full_unstemmed Simultaneous development of zanubrutinib in the USA and China
title_short Simultaneous development of zanubrutinib in the USA and China
title_sort simultaneous development of zanubrutinib in the usa and china
topic Comment
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7351534/
https://www.ncbi.nlm.nih.gov/pubmed/32651571
http://dx.doi.org/10.1038/s41571-020-0414-y
work_keys_str_mv AT liguanqiao simultaneousdevelopmentofzanubrutinibintheusaandchina
AT liuxiaozhen simultaneousdevelopmentofzanubrutinibintheusaandchina
AT chenxiaoyuan simultaneousdevelopmentofzanubrutinibintheusaandchina

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