Simcere Pharmaceuticals Group Ltd has launched QUVIVIQ (daridorexant) in China, expanding access to Idorsia's novel insomnia treatment to one of the world's largest pharmaceutical markets. The dual orexin receptor antagonist received approval without psychotropic drug control labeling, highlighting its differentiated safety profile compared to traditional sleep medications.
QUVIVIQ addresses a significant unmet medical need in China, where insomnia represents a major public health challenge. Existing treatment options such as benzodiazepines and non-benzodiazepines are often associated with next-day drowsiness, risk of dependence, withdrawal symptoms, and rebound insomnia upon discontinuation.
Targeted Mechanism of Action
Daridorexant works through a fundamentally different approach than traditional hypnotics. Rather than broadly suppressing brain activity, the drug selectively blocks the binding of orexin neuropeptides to their receptors, regulating overactive wake signaling that characterizes insomnia disorder. Through its equipotent antagonism of both orexin receptors and optimal pharmacokinetics, with approximately 80% eliminated within the first 8 hours of dosing, daridorexant promotes restorative sleep throughout the entire night while reducing morning sleepiness and improving daytime functioning.
"Today marks an important milestone in making QUVIVIQ a truly global brand," said Srishti Gupta, MD, Chief Executive Officer of Idorsia. "Thanks to the close collaboration between Simcere and Idorsia, Chinese patients now have access to a novel therapy that addresses the root cause of insomnia without the limitations associated with older classes of treatments."
Clinical Evidence Supporting Launch
The global registration program, as reported by Mignot E, et al. in the February 2022 issue of The Lancet Neurology, demonstrated robust efficacy across multiple endpoints. Both 25mg and 50mg doses of daridorexant significantly improved sleep onset, sleep maintenance and self-reported total sleep time at months 1 and 3 compared to placebo.
A major focus of the pivotal trials was evaluating daridorexant's impact on daytime functioning in patients with insomnia, assessed using the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). The sleepiness domain score of the IDSIQ served as a key secondary endpoint in both studies, with comparisons to placebo including control for multiplicity. Daridorexant 50 mg demonstrated highly significant improvement in daytime functioning, as measured by the sleepiness domain at both month 1 and month 3.
Strategic Partnership Details
The China launch stems from an exclusive licensing agreement established between Idorsia and Simcere in 2022 for Greater China, encompassing Mainland China, Hong Kong, and Macau. Under this agreement, Simcere holds exclusive rights to develop and commercialize QUVIVIQ in the region, while Idorsia has received $80M in milestone payments to date and remains eligible for additional commercial milestone payments plus tiered royalties ranging from low to high single digits on future net sales.
"We are proud to introduce QUVIVIQ to patients in China," commented Ren Jinsheng, Chairman and Chief Executive Officer of Simcere. "The positive results from both global and local clinical trials, coupled with its status as a regular prescription medication that is not subject to psychotropic drug control, position QUVIVIQ as a meaningful advancement in the treatment of chronic insomnia."
Global Market Presence
With the China launch, daridorexant is now commercially available as QUVIVIQ in 15 countries and regions, including the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, France, Sweden, Japan, Finland, Hong Kong, and China. The drug is approved throughout the European Union, representing one of the most comprehensive global rollouts for a novel insomnia treatment in recent years.
The expansion into China represents a particularly significant milestone given the country's large patient population and the substantial unmet need for safer insomnia treatments. Insomnia affects many aspects of daily life, including the ability to concentrate, mood, and energy levels, making effective treatment options crucial for patient quality of life and overall health outcomes.
