China's Luye Pharma Group said it has successfully completed three Phase I clinical studies for ansofaxine hydrochloride (LY03005) in China and submitted an application for Phase II and Phase III on the same candidate to the China Food and Drug Administration.
A total of 132 healthy subjects were enrolled for these clinical studies at a study site with significant experience in China, including 72 subjects in the single ascending dose ("SAD") study, 12 subjects in the food-effect study and 48 subjects in the multiple ascending dose ("MAD") study, the company said in a release to the Hong Kong Stock Exchange.
Ansofaxine hydrochloride is a serotonin-norepinephrine-dopamine triple reuptake inhibitor in extended release tablet form with LY03005 hoped to be approved as a Class I New Chemical Drug for the treatment of major depressive disorder, the company said.
Luye, citing IMS Health data, said the market size for anti-depressants in China in 2014 was approximately RMB3.4 billion ($553 million), and grew at a compound annual growth rate of 21% from 2011 to 2014.
In August 2014, Luye Pharma Group acquired a 58% stake in Beijing-based Jialin Pharmaceutical for close to $600 million, beefing up its pipeline of cardiovascular drugs while expanding its product lineup.
Liu Dianbo is both CEO and chairman of the firm, which listed in July last year with a focus on oncology, cardiovascular and metabolism, confident that the growing biotech can build its fortunes as the huge population in China ages.
- here's the release from the Hong Kong Exchange