Haixi Pharma gains 8% as FDA Fast Tracks wet AMD candidate

Haixi Pharma (02637.HK) jumped 8 percent after the US FDA granted Fast Track designation to HX9428 for wet age-related macular degeneration.

The designation is intended to speed development and review of drugs that treat serious conditions with unmet medical needs, the company said in an announcement. Fast Track status gives Haixi more frequent communication with the FDA and eligibility for a rolling submission of its marketing application, which can shorten the timeline to approval.

HX9428 is a candidate molecule under Haixi's self-developed innovative drug project HXP056. Shares rose HK$16.40, with short selling of HK$52,460, or 0.062 percent of turnover. The designation covers neovascular age-related macular degeneration, the most common form of the disease and a leading cause of vision loss in people over 50.

Wet AMD develops when abnormal blood vessels grow under the retina and leak fluid, damaging central vision. The treatment market is dominated by Regeneron's Eylea and Roche's Vabysmo, both blockbuster anti-VEGF injections that require repeated dosing. Fast Track status could shorten the path to market for HX9428, strengthening Haixi's position in ophthalmology and potentially drawing partnership interest from larger drugmakers seeking a differentiated option.

The designation gives Haixi a faster regulatory route as it advances HX9428 toward clinical trials. Investors will watch for the next clinical milestone and any licensing deal.

This article is for informational purposes only and does not constitute investment advice.