The approval was based on an import approval application filed by Toray and its partner 3SBio in November 2021 for alleviating pruritus in people with chronic liver disease.
3SBio is planning to market and provide information about this antipruritus medication in China excluding Taiwan, Macao, and Hong Kong.
Toray and 3SBio are preparing to introduce the product in the first half of next year.
3SBio also gained licensing rights in December 2017 to market the drug in Japan under the trade name REMITCH OD Tablets 2.5 μg.
This medication is designed for hemodialysis patients with pruritus characterised with generalised, intense itch without inflammation.
An estimated 750,000 people received hemodialysis in 2021 and around 39% of those patients suffered with moderate or severe pruritus.
Till date, no treatment has been launched in China to provide relief to hemodialysis patients with pruritus.
Both the companies hope that the new treatment will improve the quality of life of patients and serve as a new alternative for improving pruritus in China.