Assessment of the breakthrough-therapy-designated drugs granted in China: A pooled analysis 2020-2022

Xingxian Luo; Feng Qian; Lina Yang; Yanrong Li; Yue Yang

doi:10.1016/j.drudis.2022.103370

Assessment of the breakthrough-therapy-designated drugs granted in China: A pooled analysis 2020-2022

Drug Discov Today. 2022 Dec;27(12):103370. doi: 10.1016/j.drudis.2022.103370. Epub 2022 Sep 22.

Authors

Xingxian Luo¹, Feng Qian², Lina Yang³, Yanrong Li⁴, Yue Yang⁵

Affiliations

¹ School of Pharmaceutical Sciences, Tsinghua University, Beijing, China; Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing, China; Tsinghua-Peking Center for Life Sciences, Beijing 100084, China.
² School of Pharmaceutical Sciences, Tsinghua University, Beijing, China.
³ School of Pharmaceutical Sciences, Tsinghua University, Beijing, China; Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing, China.
⁴ Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China.
⁵ School of Pharmaceutical Sciences, Tsinghua University, Beijing, China; Key Laboratory of Innovative Drug Research and Evaluation, National Medical Products Administration, Beijing, China. Electronic address: yanghappy@mail.tsinghua.edu.cn.

PMID: 36154876
DOI: 10.1016/j.drudis.2022.103370

Abstract

The implementation of China's breakthrough therapy designation (BTD) program in 2020 to accelerate drug development for serious or life-threatening diseases has attracted widespread attention. Here, we review the characteristics of BTD and its implementation in China. Overall, 78 drugs with 82 BTDs were collected from the program's inception to April 2022. The time to obtain BTD for imported new drugs was significantly faster than for domestic ones. The BTDs granted for domestic new drugs were highly concentrated in oncology. The BTD drugs can reduce clinical trial and review times compared with non-BTD drugs. The implementation of BTD is expected to expedite the development of new drugs to address unmet clinical needs in China.

Keywords: Breakthrough therapy designation; China; Drug development; Expedited program; National medical products administration.

Publication types

Meta-Analysis
Review

MeSH terms

China
Drug Approval
Drug Development*
Medical Oncology*
United States
United States Food and Drug Administration