(ECNS)— China's National Medical Products Administration on Tuesday approved an innovative drug for the treatment of narcolepsy type 1, making China the first country in the world to authorize the drug for market use, CCTV News reported.
The drug is a selective orexin receptor 2 agonist intended for patients aged 16 and above. As a first-in-class therapy with a novel target and mechanism of action, it works by restoring orexin signaling and is considered the first treatment designed to address the underlying cause of narcolepsy type 1.
Narcolepsy is a rare, chronic neurological disorder. Narcolepsy type 1, which is accompanied by cataplexy, is primarily caused by the extensive loss of orexin-producing neurons in the hypothalamus, leading to a range of neurological dysfunctions. The condition therefore involves more than excessive daytime sleepiness and is regarded as a broader neurological disorder.
Developed as a treatment for a rare disease, the drug was submitted for marketing approval simultaneously in several countries and regions. In China, it was granted breakthrough therapy designation and included in the priority review and approval program.
Experts said the drug’s first approval in China reflects a shift in the research and registration strategies of multinational pharmaceutical companies, from launching products overseas before introducing them to China to conducting global development programs and filing applications in China at the same time.
China registered 410 international multicenter clinical trials in 2025, an increase of more than 20% year on year and double the number recorded in 2020.
As pharmaceutical regulatory reform continues, China is becoming an increasingly important platform for global innovative drug research, clinical validation, registration and commercialization.
(By Helen Mo, intern Wu Jingjing)
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