The board of directors of Simcere Pharmaceutical Group Limited announced that the phase III clinical study of Daridorexant hydrochloride tablets in the treatment of insomnia patients in China (NCT06010693) has read out the topline results, and has met the primary endpoint. The analysis results demonstrated that, as compared to placebo, Daridorexant hydrochloride tablets can improve various sleep-related indicators significantly, such as night-time awakenings of insomnia patients, while demonstrating good safety and tolerability at the same time. The detailed results of the Study are expected to be published in academic journals or conferences in the near future.

The Group plans to submit a New Drug Application (NDA) for Daridorexant hydrochloride tablets to the National Medical Products Administration (NMPA) of China. The Study is a multi-center, randomized, double-blind and placebo-controlled phase III clinical trial and is led by Xuanwu Hospital of the Capital Medical University, which has enrolled 206 patients at 33 research centers in China. The Study completed the first patient in (FPI) on December 17, 2023 and completed the enrollment of all patients on March 15, 2024.

The success of the Study has verified the efficacy and safety of Daridorexant hydrochloride tablets in insomnia patients in China, which is expected to bring new treatment options for patients.