VOLUNTARY ANNOUNCEMENT - PHASE III CLINICAL TRIAL OF AMMOXETINE HYDROCHLORIDE ENTERIC-COATED TABLETS (HA1406) FOR THE TREATMENT OF PATIENTS WITH DEPRESSION MET THE PRIMARY ENDPOINT
2026-07-27 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
Hong Kong Exchanges and Clearing Limited and The Stock Excha nge of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoe ver for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this ann ouncement. CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT PHASE III CLINICAL TRIAL OF AMMOXETINE HYDROCHLORIDE ENTERIC-COATED TABLETS (HA1406) FOR THE TREATMENT OF PATIENTS WITH DEPRESSION MET THE PRIMARY ENDPOINT The board of directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that the Phase III clinical trial (Protocol No.: HA1406 –007) of Ammoxetine Hydrochloride Enteric-coated Tablets ( ‘‘HA1406 ’’), a Class 1 innovative drug developed by the Group as a novel, pot ent selective dual serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor (SNRIs), for the tr eatment of patients with depression, has successfully met its pre-specified primary efficacy endpo int, with results demonstrating both statistically significant differences and clinically mea ningful benefits. HA1406 exhibited favourable efficacy and safety, and is expected to become a first-line t reatment for depression. Depression is a common mental disorder characterised by cor e clinical features of significant and persistent low mood, diminished interest and anhedonia, an d is one of the leading causes of the global disease burden. Although existing antidepressants are wid ely used in clinical practice, a considerable proportion of patients respond poorly to current treatment s. Besides, some drugs have limitations such as delayed onset of action and notable adverse reactions, re presenting a significant unmet medical need. – 1 – HA1406 –007 is a multicentre, randomised, double-blind, double-du mmy, placebo- and active- controlled, parallel-group Phase III clinical trial desig ned to evaluate the efficacy and safety of Ammoxetine Hydrochloride Enteric-coated Tablets in the tr eatment of patients with depression. The results showed that the trial met its primary endpoint, with the change from baseline in the Montgomery — Åsberg Depression Rating Scale (MADRS) score for HA1406 at t he end of Week 8 of treatment being significantly superior to that of the place bo (P 50.0001), and numerically superior to the active control. HA1406 demonstrated favourable trends of benefit across multiple secondary endpoints and showed a good safety profile. Detailed data fr om this study will be presented at a forthcoming international academic conference. HA1406 ma y offer additional treatment options for patients with depression. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 27 July 2026 As at the date of this announcement, the Board comprises Mr. C AI Dong Chen, Dr. CAI Lei, Mr. WEI Qingjie, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Dr. LI Chunlei , Dr. YAO Bing, Mr. CAI Xin, Mr. CHEN Weiping, Mr. QU Zhiyong and Mr. ZHANG Yiwei as Executive Directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, M r. LAW Cheuk Kin Stephen and Ms. LI Quan as Independent Non-executive Directors. – 2 –
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