By Fineline Cube Fujian Haixi Pharmaceuticals Co., Ltd. (HKG: 2637) announced dual clinical progress updates for HX9428, its independently developed novel oral small‑molecule drug for vascular retinal diseases. The Phase I dose‑escalation study in neovascular age‑related macular degeneration (nAMD) has been fully completed with improved visual acuity and no need for supplemental intravitreal anti‑VEGF injections, while an IND for a Phase IIa trial in diabetic macular edema (DME) has been submitted to China’s NMPA CDE — advancing a potentially injection‑free alternative to traditional intravitreal therapies on two fronts.
Clinical Evidence – Phase I in nAMD
| Item | Detail |
|---|---|
| Study Design | Phase I dose‑escalation, first indication (nAMD / wet AMD) |
| Enrollment | 15 patients across 5 dose cohorts of 5–40 mg QD |
| Completed Dosing | 13 patients (3 treatment‑naïve; 10 anti‑VEGF‑experienced) completed planned 24‑week dosing |
| Rescue Therapy | No additional intravitreal anti‑VEGF injections required throughout the dosing period |
| BCVA – Overall Population | Improved by more than 5 letters from baseline on average |
| BCVA – Treatment‑Naïve (n=3) | Improved by 12 letters from baseline on average |
| Safety | Favorable safety profile demonstrated |
The ability to maintain and improve vision over 24 weeks with an oral, once‑daily regimen — without any rescue anti‑VEGF injections — represents a compelling signal for HX9428 as a potential paradigm shift in retinal disease management, where patients today typically face repeated intravitreal injections.
Drug Profile & Development Status
- Molecule: HX9428, a novel oral small‑molecule innovative drug independently developed by Haixi Pharma for vascular retinal diseases
- Value Proposition: More convenient oral dosing versus traditional intravitreal injection therapies
- First Indication: nAMD — Phase I complete; Phase II studies ongoing concurrently in China and the United States
- Second Indication: DME — Phase IIa IND submitted to the Center for Drug Evaluation (CDE) of the NMPA
- Regulatory Designation: U.S. FDA Fast Track Designation (FTD) granted for the treatment of nAMD
Market Impact & Outlook
- Paradigm‑shift potential: An oral therapy that delivered BCVA gains without supplemental injections could reshape the treatment burden landscape in retinal diseases, where adherence is constrained by injection frequency
- Regulatory momentum: FDA Fast Track Designation for nAMD provides expedited development pathways in the U.S., while parallel Phase II execution in China and the U.S. supports a global development strategy for HX9428
- Pipeline expansion: The DME IND filing opens a second large vascular retinal indication, broadening the commercial addressable market for Haixi Pharma beyond nAMD
- Competitive positioning: If Phase II confirms the Phase I signal, HX9428 could compete with, or complement, anti‑VEGF injection regimens from major ophthalmology players by offering superior convenience
Forward‑Looking Statements — This brief contains forward‑looking statements regarding the clinical development timeline, efficacy outcomes, regulatory approvals, and commercial potential of HX9428 in nAMD and DME. Phase I results in a small patient population may not be replicated in later‑stage trials. Actual results may differ materially due to clinical, regulatory, competitive, and market risks. No investment decision should be made solely on the basis of this brief.-Fineline Info & Tech