China-based Luye Pharma Group (HKG: 2186) has announced the official commercial operation of its Rykindo (risperidone) extended-release injectable suspension in the United States. Developed on Luye Pharma’s microsphere technology platform, Rykindo is administered via intramuscular injection once every two weeks, utilizing long-acting and extended-release microsphere technology to deliver the active ingredient, risperidone.
Rykindo’s US Approval and Indications
Rykindo received marketing approval in the US in January this year for the treatment of schizophrenia in adults. It is also approved as a monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. This marks a significant milestone as Rykindo was approved in China in 2021 and is recognized as the first Chinese central nervous system (CNS) drug to be approved in the US. It is also the first complex preparation developed by a mainland Chinese company to be approved via the FDA’s 505(b)(2) pathway.
Implications for Luye Pharma and the CNS Drug Market
The commercial operation of Rykindo in the US not only signifies Luye Pharma’s expansion into the global market but also highlights the potential for Chinese pharmaceutical companies to contribute to the development of advanced CNS treatments. Rykindo’s approval and launch in the US underscore the growing capability of Chinese pharmaceuticals to meet stringent international regulatory standards and address unmet medical needs worldwide.-Fineline Info & Tech
