Recently, the new drug application for the anti-insomnia medication, QUVIVIQ (Daridorexant), developed by Simcere Pharmaceutical, a company within the Concora community, has been accepted. QUVIVIQ is a dual orexin receptor antagonist, representing a new generation of 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-class insomnia treatment approved by the European Medicines Agency for its ability to improve daytime function. In November 2022, Simcere Pharmaceutical entered into an exclusive licensing agreement with Idorsia, securing exclusive rights for the clinical development and commercialization of Daridorexant in China.
Unlike traditional sedative-hypnotic drugs that promote sleep by sedating the brain, QUVIVIQ helps patients fall asleep and maintain sleep by blocking the binding of orexin neuropeptides (orexin A and orexin B) to their receptors, without causing drowsiness or hangover feelings the next day.
The Phase III clinical study results of QUVIVIQ in China show that, compared to a placebo, taking one tablet of QUVIVIQ before bedtime significantly improves several sleep indicators for patients with insomnia, including nighttime awakenings, and it has a good safety and tolerance profile.
The clinical efficacy and value of QUVIVIQ have been authoritatively recognized both domestically and internationally. Previously, the Phase III clinical data of QUVIVIQ overseas were published in “The Lancet Neurology,” demonstrating that QUVIVIQ significantly improved sleep onset and maintenance compared to a placebo in the first and third months of treatment, without altering sleep architecture, and with a good safety and tolerance profile. Recently, QUVIVIQ has been given Level A evidence and Grade I recommendation in the “Chinese Guidelines for the Diagnosis and Treatment of Insomnia in Adults (2023 Edition),” which explicitly states the unique advantage of QUVIVIQ in “improving nocturnal sleep and daytime function, with a low incidence of daytime sleepiness,” affirming its clinical effectiveness.
About Simcere Pharmaceutical: Simcere Pharmaceutical (2096.HK) is a pharmaceutical company driven by innovation and research and development, with the establishment of the “National Key Laboratory of Neurology and Oncology Drug R&D.” The company focuses on oncology, central nervous system, autoimmune, and anti-infective areas, while also proactively looking ahead to disease areas with significant clinical needs in the future, dedicated to “providing patients with more effective medicines as soon as possible.” The company is driven by both independent research and development and collaborative innovation, establishing strategic partnerships with several innovative enterprises and scientific research institutions.
