On Jul. 16, 2024, Simcere Pharmaceutical (2096.HK) announced that the new drug application for Quviviq® (daridorexant hydrochloride tablets), an innovative anti-insomnia drug developed in collaboration with Idorsia (Switzerland), has been accepted by the National Medical Products Administration.
Quviviq® is a dual orexin receptor antagonist (DORA) and represents a new generation of anti-insomnia drugs. It has been approved for marketing in nine countries, including the United States, the United Kingdom, Switzerland, and Canada. It is currently the only DORA for the treatment of insomnia that improves daytime functioning approved by the European Medicines Agency (EMA). In Nov. 2022, Simcere Pharmaceutical entered into an exclusive licensing agreement with Idorsia, obtaining the exclusive rights for the clinical development and commercialization of Daridorexant in China.
Different from traditional sedative-hypnotic drugs that promote sleep by sedating the brain, Quviviq® helps patients fall asleep and maintain asleep by blocking the binding of orexin neuropeptides (orexin A and orexin B) to their receptors, without causing next-day drowsiness or hangover-like feelings.
Packaging of Quviviq® already marketed overseas
The results of the Phase III clinical study of Quviviq® in China showed that compared to placebo, taking one tablet of Quviviq® every night before bed significantly improved various sleep parameters in patients with insomnia, with favorable safety and tolerability profiles.
The clinical efficacy and value of Quviviq® have been recognized by authoritative bodies in China and other countries and regions. Previously, the Phase III clinical data of Quviviq® from overseas was published in The Lancet Neurology, demonstrating that Quviviq® significantly improved sleep onset and maintenance compared to placebo in the first and third months of treatment, without altering sleep architecture, and with favorable safety and tolerability profiles. Recently, Quviviq® was rated as Level A evidence, Grade I recommendation in the "Chinese Guideline for Diagnosis and Treatment of Insomnia (2023)", which clearly states that Quviviq® can "improve nighttime sleep and daytime functioning, with a low incidence of daytime sleepiness", affirming its clinical efficacy.