Measures facilitate approval of 48 first-in-class innovative drugs

China approved 48 first-in-class innovative drugs, as well as a significant number of medications for pediatric and rare diseases, thanks to measures aimed at enhancing review efficiency and accelerating patient access to novel therapies, according to a report released on Tuesday by the National Medical Products Administration.

The 48 innovative drugs cover nearly 20 therapeutic areas, including oncology, neurological disorders and anti-infective medicines, the report said. The number was the highest in the past five years, compared with 40 in 2023 and 21 in 2022.

Among them, 17 received market approval through a priority review pathway, 11 gained conditional market approval and 13 were included in breakthrough therapy programs during clinical trials, according to the report from the administration's drug evaluation center.