Tsinghua Clinical Research Institute (TCRI), School of Medicine, Tsinghua University, Beijing, China.
Office of Clinical Trial Institute, Beijing Tsinghua Changguang Hospital, Beijing, China.
Nat Rev Clin Oncol. 2020 Oct;17(10):589-590. doi: 10.1038/s41571-020-0414-y.
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.
赞布替尼最近获得美国和中国药品监管机构的加速批准，用于治疗套细胞淋巴瘤，成为中国首个同时在两国开发的新药。本文概述了中美两国监管机构的监管流程和考量因素，并讨论了同步审查和批准的途径。
