Simcere Pharmaceuticals Licenses Idorsia’s Insomnia Therapy Daridorexant for Greater China

China-based Simcere Pharmaceutical Group (HKG: 2096) has announced the establishment of a licensing agreement with Swiss firm Idorsia Ltd, securing exclusive development and commercialization rights to Idorsia’s insomnia therapy daridorexant in Greater China, including mainland China, Hong Kong, and Macau. The agreement also includes clinical research and development (R&D) activities. Simcere will pay Idorsia USD 30 million upfront, with an additional commitment of USD 20 million in milestone payments and low double-digit royalties based on future sales.

Daridorexant Profile
Daridorexant is a dual orexin receptor antagonist that specifically blocks the neuropeptide orexin, which promotes arousal, without inducing sleep by generally calming the brain. This mechanism reduces the wake-up drive and induces sleep without altering the proportion of sleep stages. Phase III clinical data has demonstrated that daridorexant significantly improved sleep onset, sleep maintenance, and total sleep time compared with a placebo. Importantly, the proportion of sleep stages remained unchanged across all treatment groups, a significant difference from the results reported by benzodiazepine receptor agonists. Daridorexant has been approved in the United States and Europe in January and April 2022, respectively, for improving night sleep and daytime function in adults with chronic insomnia.

Future Implications
The licensing agreement between Simcere and Idorsia marks a significant step in expanding access to innovative insomnia treatments in Greater China. By leveraging Idorsia’s expertise and Simcere’s local market presence, the partnership aims to address the significant unmet medical needs in the treatment of chronic insomnia. This move positions Simcere to enhance its portfolio of neurology-focused therapies and contribute to improving patient outcomes in the region.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry