{"id":78519,"date":"2026-09-03T17:20:08","date_gmt":"2026-09-03T09:20:08","guid":{"rendered":"https:\/\/flcube.com\/?p=78519"},"modified":"2026-09-03T17:20:09","modified_gmt":"2026-09-03T09:20:09","slug":"haixi-pharma-completes-phase-i-of-oral-hx9428-in-namd-with-visual-gains-files-ind-for-dme-phase-iia-as-fda-fast-track-asset-expands","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=78519","title":{"rendered":"Haixi Pharma Completes Phase I of Oral HX9428 in nAMD with Visual Gains, Files IND for DME Phase IIa as FDA Fast Track Asset Expands"},"content":{"rendered":"\n

Fujian Haixi Pharmaceuticals Co., Ltd.<\/strong> (HKG: 2637<\/a>) announced dual clinical progress updates for HX9428<\/strong>, its independently developed novel oral small\u2011molecule drug for vascular retinal diseases. The Phase I dose\u2011escalation study in neovascular age\u2011related macular degeneration (nAMD)<\/strong> has been fully completed with improved visual acuity and no need for supplemental intravitreal anti\u2011VEGF injections, while an IND for a Phase IIa trial in diabetic macular edema (DME)<\/strong> has been submitted to China’s NMPA CDE<\/strong> \u2014 advancing a potentially injection\u2011free alternative to traditional intravitreal therapies on two fronts.<\/p>\n\n\n\n

Clinical Evidence \u2013 Phase I in nAMD<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Study Design<\/td>Phase I dose\u2011escalation, first indication (nAMD \/ wet AMD)<\/td><\/tr>
Enrollment<\/td>15 patients across 5 dose cohorts of 5\u201340 mg QD<\/td><\/tr>
Completed Dosing<\/td>13 patients (3 treatment\u2011na\u00efve; 10 anti\u2011VEGF\u2011experienced) completed planned 24\u2011week dosing<\/td><\/tr>
Rescue Therapy<\/td>No additional intravitreal anti\u2011VEGF injections required throughout the dosing period<\/td><\/tr>
BCVA \u2013 Overall Population<\/td>Improved by more than 5 letters from baseline on average<\/td><\/tr>
BCVA \u2013 Treatment\u2011Na\u00efve (n=3)<\/td>Improved by 12 letters from baseline on average<\/td><\/tr>
Safety<\/td>Favorable safety profile demonstrated<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The ability to maintain and improve vision over 24 weeks with an oral, once\u2011daily regimen \u2014 without any rescue anti\u2011VEGF injections \u2014 represents a compelling signal for HX9428<\/strong> as a potential paradigm shift in retinal disease management, where patients today typically face repeated intravitreal injections.<\/p>\n\n\n\n

Drug Profile & Development Status<\/h2>\n\n\n\n