Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced the receipt of clinical trial approval from the National Medical Products Administration (NMPA) for its anti-insomnia drug, Quviviq (daridorexant), co-developed with Swiss firm Idorsia Pharmaceuticals Ltd. The dual orexin receptor antagonist (DORA) is now cleared for testing in the treatment of adult insomnia patients with symptoms persisting for at least three months and impacting daytime function.
Quviviq’s Market Presence and Mechanism of Action
Quviviq is already commercially available in the US, UK, Italy, Germany, Switzerland, and Canada. Simcere Pharma acquired the drug via a licensing deal with Idorsia Pharma in November 2022, securing exclusive development and commercialization rights in Greater China. Unlike traditional insomnia drugs such as benzodiazepines, which calm the brain to promote sleep, daridorexant reduces arousal drive and promotes sleep by blocking the activation of orexin receptors. This mechanism does not alter the sleep structure of patients and is devoid of residual effects the following day.
Clinical Studies and Long-Term Medication Safety
Overseas clinical studies have demonstrated that daridorexant can significantly improve sleep time in individuals with insomnia, supporting the safety of long-term medication use. The approval by the NMPA marks a significant step forward in expanding access to this innovative treatment for insomnia in China, potentially benefiting a large patient population.-Fineline Info & Tech
