HAIXI PHARMA (02637.HK): HX9428 Phase I and Phase II nAMD data show continued BCVA improvement

NewTimeSpace News: On 16 September 2026, Fujian Haixi Pharmaceuticals Co., Ltd. (stock code: 02637) announced that the 24-week treatment data observation of the China Phase I clinical study of HX9428, a candidate drug molecule under its self-developed innovative drug project HXP056, for the treatment of neovascular age-related macular degeneration (nAMD) has been completed, while the China Phase II dose expansion study is still ongoing with interim clinical data obtained. The Phase I study enrolled a total of 15 nAMD patients, covering five dose cohorts from 5 mg/QD to 40 mg/QD, of whom 13 patients completed 24 weeks of treatment. Among the 13 patients who completed 24 weeks of treatment, best corrected visual acuity (BCVA) improved by an average of 5.2 letters from baseline and central subfield thickness (CST) decreased by an average of 73.3 μm from baseline.

For the Phase II dose expansion study, as at 14 August 2026, a total of 80 nAMD patients had been enrolled in the three dose cohorts of 5 mg/QD, 10 mg/QD and 20 mg/QD, of whom approximately 78% were patients previously treated with anti-vascular endothelial growth factor (anti-VEGF) therapy and approximately 22% were treatment-naive patients; 45 patients had completed the Week 13 visit and 11 patients had completed 24 weeks of treatment, with BCVA improving by an average of 5.4 letters from baseline and CST decreasing by an average of 72.5 μm, consistent with the efficacy trend observed in the Phase I study. In terms of safety, no dose-limiting toxicity was observed at any of the five dose levels in the Phase I study, and the overall tolerability in the Phase II study to date has been good. The Company also cautioned that HX9428 has not obtained marketing approval from any drug regulatory authority and that the interim results require further verification as the studies progress and the sample size increases.

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