Haixi New Pharmaceutical (02637): HX9428 was granted fast-track status by the US FDA for the treatment of neovasculatory age-related macular degeneration

Zhitong Financial App News, Haixi New Pharmaceutical (02637) announced that the drug candidate HXP9428 of the innovative drug project HXP056 developed by the company was granted Fast Track Designation (“FTD”) by the US Food and Drug Administration (U.S. Food and Drug Administration, “FDA”) to develop treatments for angiogenic age-related macular degeneration (nephrogenesis) agerelated macular degeneration (“NaMD”, also known as wet age-related macular degeneration, “wAMd”). Being granted FTD certification this time will help the company to develop closer communication with the FDA on the clinical development of HX9428 and advance its global clinical development process.

HX9428 is a new innovative oral small molecule drug independently developed by Haixi Pharmaceutical. It is intended to be used to treat NaMD. Currently, anti-vascular endothelial growth factor (anti-VEGF) treatment is still the standard treatment for NaMD. However, current treatment requires injection into the vitreous cavity of the eye, and patients may face medical burdens, compliance challenges, and injection-related risks due to long-term and repeated treatments. HX9428 uses oral administration, which is expected to provide NaMD patients with more convenient administration options than traditional injection therapy, help improve patients' long-term treatment compliance, and solve existing clinical treatment pain points.

At present, the domestic R&D process of HX9428 is progressing steadily, and phase I clinical studies have been successfully completed. At this stage, phase II dose extension studies and a second phase II clinical study using positive controls are being carried out. Overseas R&D has been implemented simultaneously. Hx9428 has been approved by the FDA to conduct NAMD Indication Phase II clinical trials in the US. The company is making every effort to advance the US clinical development layout to benefit patients around the world as soon as possible.