CHINESE drug regulatory authorities have approved a new anti-insomnia medication, according to Chinese media reports.

Simcere Pharmaceutical Group Ltd., a Hong Kong-listed company headquartered in Nanjing, Jiangsu Province, announced that the National Medical Products Administration has approved Quviviq for the treatment of insomnia in adult patients. The drug was developed in collaboration with the Swiss company Idorsia.

This new-generation medication received approval following a multi-center Phase III clinical trial conducted in China, complemented by Idorsia’s global clinical trials, both confirming the drug’s efficacy. The Chinese clinical study was led by Professor Wang Yuping of Xuanwu Hospital, Capital Medical University, in Beijing.

Clinical studies conducted domestically and internationally demonstrated that the tablets effectively improve the time of persistent sleep, reduce wakefulness after sleep onset, and enhance self-reported total sleep time, sleep quality, and daytime functioning in adults with insomnia.

“This therapy marks the first dual breakthrough in improving both nighttime sleep and daytime functioning. It is expected to fill the gap in long-term, safe insomnia management, signaling the end of dependence and residual effects associated with traditional hypnotics,” stated Professor Wang.

Ren Jinsheng, Chairman and CEO of Simcere Pharmaceutical, said, “Quviviq represents a groundbreaking innovation in global sleep medicine. We look forward to offering this internationally recognized therapy to a large number of insomnia patients as a more effective and safer option.”

According to the latest data released by the Chinese Sleep Research Society in March, nearly half of Chinese adults experience sleep disturbances, with a higher prevalence among women and an increasing incidence with age. Primary symptoms include difficulty falling asleep, nighttime awakenings, and early morning awakenings.(SD-Agencies)