Luye Pharma's antidepressant LY03005 accepted for US FDA review

4 March 2020

The US Food and Drug Administration has reviewed and accepted the filing of a New Drug Application (NDA) for LY03005, a new chemical drug for the treatment of major depressive disorder.

LY03005 is China-based Luye Pharma’s (SEHK: 2186) second drug in the central nervous system (CNS) therapeutic area currently in the US FDA's NDA phase. The news saw Luye’s close up a modest 1.8% at HK$4.88.

LY03005 is an exclusive CNS product developed under Luye Pharma's New Chemical and Therapeutic Entities (NCE/NTE) R&D platform, and is a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI), with one of the active metabolites being a serotonin-norepinephrine reuptake inhibitor (SNRI). Luye Pharma has obtained patents covering the chemical compound, crystal form and formulation of LY03005. The patents relating to the chemical compound and crystal form have been granted in target markets such as China, the USA, Europe, Japan and Korea.

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