HAIXI PHARMA Reports Positive 24-Week Phase I Results and Interim Phase II Progress for Oral nAMD Candidate HX9428

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Hong Kong-listed HAIXI PHARMA announced updated clinical data for HX9428, its orally administered small-molecule therapy under development for neovascular age-related macular degeneration (nAMD).

Phase I Highlights • Fifteen patients were enrolled across five dose levels (5–40 mg once daily); 13 completed 24 weeks of treatment. • Mean best corrected visual acuity (BCVA) improved by 5.2 letters, while central subfield thickness (CST) declined by 73.3 μm from baseline. • No dose-limiting toxicity was observed. Adverse events were generally low grade; transient Grade 1 ALT and AST elevations were each reported once. Grade 3 hypertension events appeared in higher-dose cohorts but were controllable.

Phase II Interim Read-out • As of 14 August 2026, 80 patients had been enrolled in three dose cohorts (5, 10, 20 mg). Anti-VEGF-experienced patients represented 78 % of enrolment; 22 % were treatment-naïve. • Forty-five patients reached Week 13, and 11 completed Week 24. Among the latter group, BCVA rose by 5.4 letters and CST decreased by 72.5 μm, mirroring Phase I trends. • Safety findings aligned with Phase I: no gastrointestinal adverse events or hair whitening. Reported events—primarily elevated blood pressure and laboratory fluctuations—were mostly low grade, each occurring in fewer than 10 % of patients.

Regulatory Status and Caution HX9428 has not received marketing approval in any jurisdiction. The company emphasized that interim results may not predict final outcomes and that development entails significant risk. Shareholders and potential investors are advised to approach the data with appropriate caution.

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