RareStone Group, a China-based company specializing in rare diseases (formerly known as Citrine Medicine), has secured marketing approval from the National Medical Products Administration (NMPA) for pitolisant, its in-licensed drug candidate. The histamine 3 (H3) receptor antagonist/inverse agonist is now approved for treating excessive daytime sleepiness (EDS) or cataplexy in adolescents and children over six years old with narcolepsy, expanding its use beyond the previous indication for adult narcolepsy in China.
Pitolisant, which received approval in the EU and US in March 2016 and August 2019 respectively for treating episodic sleeping sickness with or without sudden onset cataplexy, was granted breakthrough therapy designation in the US in 2020, in addition to orphan drug designations (ODDs) in both regions. In 2020, RareStone entered into a licensing agreement with French firm Bioprojet Pharma, acquiring development rights for the drug in China, where it was first approved in June 2023. Its pediatric indication was granted priority review status in July 2023, and it was subsequently included in the National Reimbursement Drug List in December of the same year.- Flcube.com
