HAIXI PHARMA (02637) has announced that its independently developed innovative drug candidate, HX9428, from the HXP056 project, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of neovascular age-related macular degeneration (nAMD), also known as wet age-related macular degeneration (wAMD).

The receipt of FTD is expected to facilitate more streamlined communication between the company and the FDA regarding the clinical development of HX9428, thereby accelerating its global clinical advancement timeline.

HX9428 is a novel oral small-molecule drug developed in-house 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 injections into the eye, subjecting patients to potential long-term, repeated treatment burdens, compliance challenges, and injection-related risks.

By adopting an oral administration route, HX9428 offers a potentially more convenient therapeutic option for nAMD patients compared to traditional injection therapies. This novel approach may enhance long-term patient adherence and directly address key unmet needs in current clinical practice.

Domestically, the research and development progress for HX9428 is advancing steadily. The Phase I clinical study has been successfully completed, and the company is currently conducting a Phase II dose-escalation expansion study as well as a second Phase II trial employing an active comparator control.

Overseas development is progressing in parallel, with the FDA having approved the initiation of a Phase II clinical trial for HX9428 in the nAMD indication within the United States. The company is fully dedicated to advancing its U.S. clinical development strategy, aiming to bring this potential treatment to patients worldwide as soon as possible.