Haisco drug application accepted by FDA

Haisco Pharmaceutical Group announced the U.S. FDA accepted the New Drug Application for HSK3486 (remimazolam tosylate for injection), marking a crucial step in the company's internationalization strategy.

HSK3486 was approved in China in December 2020 and received FDA approval to enter Phase III clinical trials in January 2021. The company completed all clinical studies in 2024.