Zhitong Finance App News, Shiyao Group (01093) announced that the Phase III clinical trial (Test Plan No.: HA1406 — 007), a Class 1 innovative drug developed by the Group — a novel potent selective 5-serotonin (5-HT) /norepinephrine (NE) double reuptake inhibitor (SNRIs) amxetine hydrochloride enteric tablets (HA1406) for treating patients with depression (Test Plan No.: — 007) has successfully reached the pre-set main efficacy endpoints. The test results have both significant statistical differences and clear clinical benefits. HA1406 has shown excellent efficacy and safety, and is expected to be a first-line treatment for depression.

HA1406 — 007 is a multi-center, randomized, double-blind, double-simulation, placebo-positive parallel controlled phase III clinical trial aimed at evaluating the efficacy and safety of amxetine hydrochloride enteric tablets in the treatment of patients with depression. The results showed that this trial reached the main end point. At the end of the 8th week of HA1406 treatment, the Montgomery-Eisberg Depression Scale (MADRS) score was significantly superior to the baseline change value compared to placebo (P50.0001), and numerically superior to the positive control drug. HA1406 has shown a good benefit trend in multiple secondary endpoint assessments and is safe. Detailed data from this study will be presented at an upcoming international academic conference. HA1406 can provide more treatment options for people with depression.

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