Xiansheng Pharmaceutical (02096): Anti-insomnia drug Keweike® was approved by the State Drug Administration for listing in China

Zhitongcaijing · 06/20/2025 15:09

Zhitong Finance App News, Xiansheng Pharmaceutical (02096) announced that on June 20, 2025, the anti-insomnia drug Corvec® (Daliraxen hydrochloride tablets), which the Group cooperates with Idorsia Pharmaceuticals Ltd. (Dorsia), was approved by the China National Drug Administration (NMPA) to be listed in China to treat adult insomnia patients characterized by difficulty falling asleep and/or maintaining sleep, and is not regulated as a psychotropic drug.

Corvex ® is a dual orexin receptor antagonist (DORA). Unlike traditional sedative and hypnotic drugs that promote sleep by calming the brain, Covec® blocks the binding of awake-promoting orexin neuropeptides (orexin A and orexin B) to their receptors. Therefore, Corvac ® reduces wake-up drive, induces sleep, reduces waking time after falling asleep, and extends sleep time without changing sleep structure. Clinical study results showed that Corvico ® was safe and well tolerated, and no evidence of rebound insomnia, withdrawal symptoms, or drug abuse were found. In addition to improving nighttime sleep in adults with insomnia disorder, Covec® can also improve patients' daytime function. It is the only DORA type of insomnia drug approved by the European Medicines Regulatory Authority (EMA) to improve daytime function. The “Chinese Guidelines for the Diagnosis and Treatment of Insomnia Disorders (2nd Edition)” published in 2025 listed Coveke® as a strong recommendation and A-level evidence. Previously, Corvico ® was approved for listing in 11 countries including the US, the UK, Switzerland, Canada, and Hong Kong, China.