Fujian Haixi Pharmaceuticals Co., Ltd. (Haixi Pharma) has received U.S. Food and Drug Administration (FDA) approval to begin a Phase II clinical trial of its oral candidate HX9428 (also known as HXP056) for the treatment of neovascular age-related macular degeneration (nAMD).

The FDA-cleared study will evaluate the efficacy and safety of multiple oral doses of HX9428 in U.S. patients with nAMD, a sight-threatening retinal disorder currently managed mainly by intravitreal anti-VEGF injections.

Concurrently, Haixi Pharma has initiated a second Phase II trial in China (Registration No. CTR20262884). The multi-center, randomized, open-label study will enrol 60 patients and compare HX9428 directly with the standard therapy Aflibercept, aiming to generate head-to-head efficacy and safety data.

HX9428 is designed to offer an oral alternative to injection-based regimens, targeting improved patient adherence and reduced treatment burden. To date, the candidate has not secured marketing approval in any jurisdiction; its safety and efficacy remain subject to ongoing clinical validation.

Management highlighted that the dual Phase II programmes represent a meaningful milestone in the asset’s global development strategy. Further updates will be disclosed as the trials progress.