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

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.