CSPC Pharma: Ammoxetine (HA1406) Clears Phase III with Statistically Significant Efficacy in Depression

Bulletin Express
07/27

CSPC Pharmaceutical Group Limited (CSPC Pharma) reported that its Class 1 innovative drug Ammoxetine Hydrochloride Enteric-coated Tablets (HA1406) achieved the primary efficacy endpoint in a multicentre, randomised, double-blind Phase III clinical trial (Protocol No. HA1406-007) for major depressive disorder.

The trial evaluated HA1406—a selective dual serotonin and norepinephrine re-uptake inhibitor—against both placebo and an active comparator over eight weeks. Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score for HA1406 demonstrated a statistically significant improvement versus placebo (P < 0.0001) and was numerically superior to the active control. Multiple secondary endpoints also showed favourable trends, and the overall safety profile was described as good.

CSPC Pharma highlighted that HA1406’s efficacy and safety position it as a potential first-line therapy for depression, addressing limitations of existing treatments such as delayed onset and adverse reactions. Detailed data will be presented at an upcoming international academic conference.

The Board of CSPC Pharma authorised the release of this information on 27 July 2026, with Chairman Cai Dong Chen signing the announcement.

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