Lemborexant

Insomnia is a sleep disorder disease with high incidence worldwide. For a long time, benzodiazepine drugs commonly used in clinical practice have many limitations such as addiction and next-day residual sedation. Lemborexant is an orexin receptor antagonist class of anti-insomnia active pharmaceutical ingredient. It can inhibit the excessive arousal signals of the central nervous system by dual blocking of orexin OX1 and OX2 receptors, shorten sleep onset latency and prolong total sleep time without extensive inhibition of neuronal activity, and has a lower risk of next-day residual effects. It is mainly used for the treatment of insomnia disorder in adults, especially suitable for the patient group who have poor tolerance to traditional sedative-hypnotic drugs and have concerns about drug dependence.

The scale of the global insomnia drug market has been growing steadily in recent years, and it has exceeded USD 16 billion in 2023. Among them, orexin receptor antagonist drugs have a compound annual growth rate of more than 20%, making them the fastest growing segment. The original research patent of lemborexant will expire in China not until 2035. At present, no generic drug has been approved in China, and more than 10 pharmaceutical companies have submitted marketing applications for generic drugs, which are in the review and approval stage, and the demand for relevant consistency evaluation research continues to rise.

CATO can provide a full set of impurity reference standards for lemborexant active pharmaceutical ingredient. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, with sufficient in-stock inventory. It can quickly respond to the reference standard supply demand in the R&D and production stages, and help enterprises efficiently promote quality research and registration and declaration work.