HAIXI PHARMA (02637): HX9428 has been granted Fast Track designation by the U.S. FDA for the treatment of neovascular age-related macular degeneration.

HAIXI PHARMA (02637) announced that its independently developed innovative drug project HXP056 has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the candidate drug molecule HX9428, aimed at developing treatments for neovascular age-related macular degeneration (nAMD), also known as wet age-related macular degeneration (wAMD). The granting of FTD will facilitate closer communication between the company and the FDA regarding the clinical development of HX9428, advancing its global clinical development process. HX9428 is a brand-new oral small molecule innovative drug independently developed by HAIXI PHARMA for the treatment of nAMD. Currently, anti-VEGF treatment remains the standard therapy for nAMD. However, existing treatments require intravitreal injections, which can impose a long-term medical burden on patients, present compliance challenges, and pose injection-related risks. The oral administration of HX9428 is expected to provide a more convenient treatment option for nAMD patients compared to traditional injection therapies, helping to improve long-term patient compliance and address existing clinical treatment pain points. At present, the domestic development process of HX9428 is progressing steadily, having successfully completed Phase I clinical trials. It is currently conducting Phase II dose-expansion studies and a second Phase II clinical trial using a positive control. The overseas development is also advancing, as HX9428 has received FDA approval to conduct Phase II clinical trials for nAMD indications in the United States. The company is fully committed to promoting the clinical development layout in the U.S. with the aim of benefiting patients globally as soon as possible.