Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in partnership with Swiss pharmaceutical firm Idorsia Pharmaceuticals Ltd, has achieved a significant milestone with the acceptance of their marketing approval filing for Quviviq (daridorexant) by China’s National Medical Products Administration (NMPA). Quviviq is an innovative anti-insomnia drug that has already gained commercial availability in the US, UK, Italy, Germany, Switzerland, and Canada. The drug’s mechanism of action involves targeting orexin receptors, offering a novel approach to sleep induction without the next-day residual effects commonly associated with traditional insomnia treatments .
Daridorexant, a dual orexin receptor antagonist (DORA), has demonstrated promising results in clinical trials, showing significant improvements in sleep onset and maintenance without altering the sleep structure of patients. This sets it apart from traditional treatments like benzodiazepines, which can leave patients feeling groggy the next day. The drug was licensed to Simcere Pharma in November 2022 for exclusive development and commercialization rights in Greater China .
The acceptance of the marketing approval filing by the NMPA is a crucial step towards potentially expanding access to this innovative treatment for patients in China. If approved, Quviviq would be positioned to address a substantial unmet medical need, as it is estimated that over 200 million people in China suffer from chronic insomnia . The drug’s approval could significantly impact the treatment landscape for insomnia in China, offering a new therapeutic option with a favorable safety profile and proven efficacy .
Simcere Pharmaceutical’s commitment to bringing Quviviq to the Chinese market reflects the company’s dedication to improving patient outcomes and expanding its presence in the CNS therapy segment. The partnership with Idorsia Pharmaceuticals highlights the potential for international collaborations to introduce groundbreaking treatments to patients globally .- Flcube.com
