{"id":61210,"date":"2026-03-25T13:00:28","date_gmt":"2026-03-25T05:00:28","guid":{"rendered":"https:\/\/flcube.com\/?p=61210"},"modified":"2026-03-25T13:00:29","modified_gmt":"2026-03-25T05:00:29","slug":"haixi-pharma-advances-hxp056-to-phase-ii-oral-multi-selective-therapy-for-wet-amd-and-hemorrhagic-retinal-diseases","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=61210","title":{"rendered":"Haixi Pharma Advances HXP056 to Phase II \u2013 Oral Multi\u2011Selective Therapy for Wet AMD and Hemorrhagic Retinal Diseases"},"content":{"rendered":"\n

Fujian Haixi Pharmaceuticals Co., Ltd.<\/strong> (HKG: 2637<\/a>) announced the initiation of a Phase II clinical study<\/strong> for HXP056<\/strong>, its oral multi\u2011selective therapy<\/strong> for hemorrhagic retinal diseases<\/strong>, following successful completion of Phase I<\/strong> in Chinese patients with wet age\u2011related macular degeneration (wAMD)<\/strong> \u2013 advancing a first\u2011in\u2011class oral candidate<\/strong> designed to penetrate the blood\u2011retinal barrier<\/strong> and address multiple retinal vascular indications.<\/p>\n\n\n\n

Clinical Development Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>Fujian Haixi Pharmaceuticals Co., Ltd. (HKG: 2637)<\/td><\/tr>
Product<\/strong><\/td>HXP056 \u2013 oral multi\u2011selective therapy<\/td><\/tr>
Development Platform<\/strong><\/td>MultiSel\u2011Opt<\/strong> \u2013 proprietary platform<\/td><\/tr>
Phase I Status<\/strong><\/td>Completed<\/strong> in Chinese wAMD patients<\/td><\/tr>
Phase II Status<\/strong><\/td>Initiated<\/strong><\/td><\/tr>
Lead Indication<\/strong><\/td>Wet age\u2011related macular degeneration (wAMD)<\/td><\/tr>
Expansion Indications<\/strong><\/td>Diabetic macular edema (DME), retinal vein occlusion (RVO)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Product Profile \u2013 Multi\u2011Selective Oral Innovation<\/h2>\n\n\n\n
Feature<\/th>HXP056 Design<\/th>Therapeutic Advantage<\/th><\/tr><\/thead>
Mechanism<\/strong><\/td>Single\u2011agent, multi\u2011selective<\/strong> targeting<\/td>Addresses multiple pathogenic pathways in retinal vascular disease<\/td><\/tr>
Administration<\/strong><\/td>Oral<\/strong> (vs. intravitreal injection standard)<\/td>Patient convenience<\/strong>; reduced injection burden; potential for self\u2011administration<\/td><\/tr>
Technical Innovation<\/strong><\/td>Blood\u2011retinal barrier (BRB) penetration<\/strong> + optimized systemic exposure<\/strong><\/td>Reaches retinal lesion sites while minimizing systemic toxicity<\/td><\/tr>
Indication Breadth<\/strong><\/td>wAMD \u2192 DME \u2192 RVO<\/td>Platform indication expansion<\/strong> across hemorrhagic retinal diseases<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Phase I Evidence<\/h2>\n\n\n\n
Endpoint<\/th>Result<\/th>Phase II Implication<\/th><\/tr><\/thead>
Safety\/Tolerability<\/strong><\/td>Favorable profile<\/strong><\/td>Supports dose escalation and expansion to additional indications<\/td><\/tr>
Pharmacokinetics<\/strong><\/td>Clear dose\u2011exposure relationship<\/strong><\/td>Enables rational dose selection for Phase II efficacy evaluation<\/td><\/tr>
Target Engagement<\/strong><\/td>Preliminary efficacy signals (implied)<\/td>Justifies Phase II investment in wAMD and expansion cohorts<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Context & Competitive Positioning<\/h2>\n\n\n\n
Dimension<\/th>Retinal Vascular Disease Landscape<\/th>HXP056 Position<\/th><\/tr><\/thead>
Standard of Care<\/strong><\/td>Intravitreal anti\u2011VEGF injections (aflibercept, ranibizumab, bevacizumab) \u2013 monthly\/bimonthly<\/td>Oral alternative<\/strong> \u2013 eliminates injection burden; potential for improved compliance<\/td><\/tr>
Oral Competition<\/strong><\/td>Limited; NOV1801 (Novartis, Phase II) \u2013 VEGF\/PDGF inhibitor; X\u201182 (Tyrogenex, Phase III)<\/td>Multi\u2011selective mechanism<\/strong> may offer superior efficacy vs. single\u2011target oral approaches<\/td><\/tr>
Unmet Need<\/strong><\/td>Injection fatigue; treatment burden; ~30\u201140% suboptimal responders to anti\u2011VEGF<\/td>Oral therapy with BRB penetration<\/strong> addresses compliance and access barriers<\/td><\/tr>
Market Size<\/strong><\/td>Global wAMD\/DME\/RVO therapeutics US$15+ billion<\/strong>; China RMB10\u201115 billion<\/strong><\/td>Significant opportunity if oral efficacy matches intravitreal standard<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Market Impact & Outlook<\/h2>\n\n\n\n