HAIXI PHARMA (02637.HK): HX9428 for Neovascular Age-Related Macular Degeneration Granted Fast Track Designation by US FDA

NewTimeSpace News: On 17 August 2026, Fujian Haixi Pharmaceuticals Co., Ltd. (stock code: 02637) announced that HX9428, the candidate drug molecule of its self-developed innovative drug project HXP056, has been granted Fast Track Designation (FTD) by the US Food and Drug Administration (FDA) for the development of treatment for neovascular age-related macular degeneration (nAMD, also known as wet age-related macular degeneration, wAMD). The FTD grant will facilitate closer communication between the company and the FDA on the clinical development of HX9428 and advance its global clinical development.

HX9428 is a novel oral small-molecule innovative drug self-developed by Haixi Pharma, intended for the treatment of nAMD. Currently, anti-vascular endothelial growth factor (anti-VEGF) therapy remains the standard of care for nAMD; however, existing treatments require intravitreal injection into the eye, and patients may face the medical burden, adherence challenges and injection-related risks of long-term, repeated treatment. HX9428 is administered orally, offering nAMD patients a more convenient option than conventional injection therapy, potentially improving long-term treatment adherence and addressing the pain points of current clinical treatment.

Fast Track Designation is an accelerated development and review channel established by the FDA for innovative drugs targeting serious diseases with unmet clinical needs. After receiving this designation, a drug can engage in frequent, timely dedicated communication with the FDA throughout clinical development and review; it qualifies for subsequent priority review and accelerated approval applications; and it may adopt a rolling review model, submitting completed research module data in batches without waiting for the full New Drug Application (NDA) dossier, helping to shorten the overall review cycle. The FDA requires two core criteria for FTD: the drug targets a serious condition, and it can address unmet medical needs in the clinic. The FDA's grant of FTD to HX9428 in the nAMD indication is recognition of its innovative drug design and potential clinical value.

Domestically, the R&D progress of HX9428 is advancing steadily: the Phase I clinical study has been completed, and the company is currently conducting a Phase II dose-expansion study and a second Phase II clinical study with an active comparator. Overseas R&D is progressing in parallel: HX9428 has received FDA approval to conduct a Phase II clinical trial for the nAMD indication in the United States. HX9428 is intended for the treatment of vascular retinal-related diseases including nAMD, diabetic macular edema (DME) and retinal vein occlusion (RVO), and is expected to break through the current limitation of treatment relying mainly on intraocular injection, offering patients more convenient treatment options. As of the date of this announcement, HX9428 has not been approved for marketing by any drug regulatory authority in any country or region, and its safety and efficacy remain subject to further clinical validation.

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