Mar. 27, 2015
Luye Pharma Group Ltd. announced on March 27, 2015 that the Group has officially completed three phase 1 clinical studies for ansofaxine hydrochloride extended release tablets (‘‘LY03005’’) in China. The objective of these clinical studies was to evaluate the safety and pharmacokinetic profiles of LY03005 following single or multiple doses of oral administration. A total of 132 healthy subjects were enrolled for these clinical studies.
LY03005 is a key central nervous system product candidate being concurrently developed for the Chinese and international market, and is currently undergoing phase I clinical trials in the United States as well.
It is expected to be approved as a Class I “New Chemical Drug” for the treatment of major depressive disorders.