The board of directors of Luye Pharma Group Ltd. announced that the Group's product candidate, ansofaxine hydrochloride extended release tablets, a New Chemical Entity (NCE) and China Class 1.1 New Chemical Drug, has completed a phase II clinical trial in the People's Republic of China. The Phase II Trial showed positive results for the treatment of major depressive disorder (MDD'). The Group will request the End-of-Phase 2 Meeting regarding the Phase II Trial with the China Food and Drug Administration (CFDA) to discuss further clinical development plan for LY03005. The Group has confidence in furthering the project. LY03005 is a central nervous system product candidate being developed within new compounds platform. It is a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) in extended release tablet form for the treatment of MDD. Traditional anti-depressants such as selective serotonin reuptake inhibitors (SSRIs) and serotonin- norepinephrine reuptake inhibitors (SNRIs) drugs are typically associated with disadvantages such as anhedonia, sexual dysfunction and inability to improve cognitive impairment. LY03005 is expected to help preserve patients' sexual function, have a better safety profile and produce a more rapid onset and better efficacy than traditional anti-depressants. The Group had obtained patents covering the chemical compound, crystal form and formulation of extended release tablets. The patents of the chemical compound and crystal form had been granted in the target countries such as China, United States, Europe, Japan, Korea, etc. Those patents of the chemical compound were granted and will be valid until 2026 (or 2029 specifically in U.S.). The Group plans to register and launch LY03005 in the U.S., Japan, China, Europe and other countries. Prior to the Phase II Trial, the Group had completed three phase I clinical trials for LY03005 in China. The Phase II Trial was designed as a multicenter, randomized, double-blind, placebo-controlled dose-finding trial conducted in 10 sites. 260 subjects with MDD were randomly assigned into the LY03005 groups or the placebo group. The preliminary results of the Phase II Trial met the primary efficacy endpoint, the reduction in 17-item Hamilton Rating Scale (HAM-D17) total scores from baseline to week 6 was all statistically greater for three dose groups of LY03005 (40mg, 80mg and 160mg) compared with placebo (p0.05). For the key secondary endpoint, the mean change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total scores at week 6, all LY03005 groups were also statistically significantly superior to placebo (p0.05). In addition, LY03005 was generally safe and well tolerated and the side effects of LY03005 were mostly mild to moderate, including common adverse events such as nausea, dizziness, etc. These findings preliminarily demonstrated the efficacy and safety of LY03005 in the treatment of MDD. In most of the phase II clinical trials of other anti-depressants, the primary efficacy endpoint is difficult to reach a statistical difference because of the small sample size in general. In the LY03005 Phase II Trial, despite the small sample size, the experimental groups achieved statistically significant differences compared with the placebo group, which was an encouraging result.