Fujian Haixi Pharmaceuticals Co., Ltd. (Haixi Pharma) announced the full enrollment of patients into both the single ascending dose and multiple ascending dose cohorts of its Phase I clinical trial for HXP056, an investigational oral therapy targeting wet age-related macular degeneration (wAMD). Enrollment began in early July 2025, and the company has already initiated a Phase II dose-expansion study in 4Q 2025.

Developed via Haixi Pharma’s proprietary MultiSel-Opt small-molecule platform, HXP056 is engineered to penetrate the blood-retinal barrier while maintaining controlled systemic exposure. The compound employs a single-molecule, multi-selective mechanism aimed at treating hemorrhage-related retinal diseases, including wAMD, diabetic macular edema and retinal vein occlusion. If successful, HXP056 could become the world’s first oral therapy in this indication space.

Interim Phase I findings show favorable safety and tolerability, with a clear dose-exposure relationship. Early signals of efficacy include improvements in fundus morphology and retinal function among both treatment-naive and previously treated wAMD patients.

The Phase II study will refine dose selection to support future Phase III trials. Haixi Pharma emphasized that HXP056 must complete all clinical phases and secure National Medical Products Administration approval before commercialization, and that drug development timelines and outcomes remain subject to significant uncertainty.