HAIXI PHARMA (02637): HX9428 has successfully completed Phase I clinical trials for neovascular age-related macular degeneration (nAMD) and submitted an Investigational New Drug (IND) application for a Phase IIa clinical trial for the new indication of diabetic macular edema (DME).

HAIXI PHARMA (02637) announced that its self-developed innovative drug project HXP056 has formally submitted an Investigational New Drug (IND) application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for a new indication, diabetic macular edema (DME), on August 31, 2026. DME is the second indication for HX9428, marking another milestone in the development of this oral retinal innovative drug. As of the date of this announcement, HX9428 has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) and is concurrently conducting Phase II clinical studies for the first indication, neovascular age-related macular degeneration (nAMD, also known as wet age-related macular degeneration, wAMD), in both China and the U.S. Recently, interim data from the Phase I study concluded in February 2026 was presented in an abstract at the American Academy of Ophthalmology (AAO) 2026 annual meeting. To date, the dose-escalation study for Phase I nAMD has been completed, enrolling a total of 15 patients across five doses of 5-40 mg/QD, with 13 patients (including 3 treatment-nave patients and 10 patients who had previously received anti-VEGF treatment) completing the planned 24-week treatment without needing additional vitrectomy with anti-VEGF drugs. The study data indicated that the overall population experienced an average improvement of over 5 letters in Best Corrected Visual Acuity (BCVA), with the average BCVA improvement of 12 letters observed in the 3 treatment-nave patients. The preliminary data suggest that HX9428 has good safety characteristics and potential efficacy signals, although its safety and effectiveness still need to be verified through further clinical research. The company will continue to vigorously advance the progress of HX9428 across multiple clinical studies in both China and the U.S.