China’s drug regulator has for the first time approved a novel, globally trialled medicine ahead of authorities in the United States, Japan and Europe, marking a “historic breakthrough” as the country doubles down on biopharmaceuticals as one of its growth engines.
The drug was filed for market approval in multiple countries, and “China was the first in the world to approve it”, Xu Xiaoqiang, head of chemical drugs registration at the National Medical Products Administration (NMPA), told state broadcaster CCTV on Tuesday.
“It marks a historic breakthrough for China” in globally developed, first-in-class drug innovation, Xu said, noting that Chinese patients had been included from the outset in international clinical trials, enabling approval ahead of anywhere else.
The NMPA gave the green light for commercial sales of a rare-disease therapy for narcolepsy type 1 in people aged 16 and older, state media reported.
The drug was not named, but reports said it had won fast-track designations in the US and orphan-drug designation in Japan and the European Union. Orphan-drug status means a therapy for a rare disease gets government incentives like tax breaks and exclusive rights to make development viable.
Narcolepsy type 1 is a lifelong brain condition that makes people intensely sleepy during the day and causes them to fall asleep without warning. For many sufferers, it also causes them to suddenly lose control of their muscles when they feel strong emotions, like laughing, being surprised, or getting angry.