Gelonghui, July 16, 丨 Xiansheng Pharmaceutical (02096.HK) announced that on July 16, 2024, the new drug marketing application (NDA) for insomnia drug Keweike (Daliraxen hydrochloride) in cooperation with Idorsia Pharmaceuticals Ltd. (Idorsia)) was accepted by the China National Drug Administration (NMPA).

Daly Rayson is a dual appetitin receptor antagonist (DORA) that blocks the binding of appetitin neuropeptides (appetitin A and appetite B) that promote wakefulness to their receptors. Unlike normal sedation to promote sleep, Dali Rayson only blocks the activation of appetite neuropeptides on appetite receptors. Therefore, Daly Rayson reduces the drive to wake up and induces sleep without altering the sleep structure. Overseas data on Dali Rayson Phase III has been published in “Lancet Neurology”: Major studies have shown that in the 1st and 3rd months of treatment, Daly Raison significantly improved sleep, sleep maintenance, and self-reported total sleep time compared to placebo, and did not change sleep structure. Furthermore, the study also showed that Dalirachen was safe and well tolerated, and no evidence of rebound insomnia, withdrawal symptoms, or drug abuse were found, significantly distinguishing from the results reported by benzodiazepine receptor agonists. Dalilaxen has obtained clinical data on continuous treatment for up to 12 months. The results support that Dalilaxen can be used for a long time. In addition to improving nighttime sleep in adults with chronic insomnia disorder, Dalilaxen 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. Previously, Dali Raison (product name: QUVIVIQ) was approved in the US, UK, Italy, Germany, Switzerland, and Canada.