Haixi New Drug (02637): HX9428 successfully completed the phase I clinical study of neovascularized age-related macular degeneration (NaMD) and submitted a phase IIa new drug clinical trial application (IND) for the new indication diabetic macular edema (DME)

Zhitong Financial App News, Haixi New Pharmaceutical (02637) announced that the candidate drug molecule HXP9428 for the innovative drug project HXP056 developed by the company officially submitted a Phase IIa clinical trial application (IND) for diabetic macular edema (diabetic macular edema, “DME”) to the China National Drug Administration (NMPA) Drug Evaluation Center (CDE) on August 31, 2026. DME is the second indication promoted by HX9428 and marks another milestone in the development of this innovative oral intraocular 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 simultaneously carrying out the first indicative neovascular age-related macular degeneration (neovascular age-related macular degeneration) in China and the US “NaMD”, also known as wet age-related macular degeneration, wAMd) is a phase II clinical study. Recently, phased data from the Phase I study up to February 2026 have been released in the abstracts of the 2026 American Academy of Ophthalmology (American Academy of Ophthalmology, “AAO” for short). Up to now, all phase I NAMD dose-climbing studies have been completed. Of these, 15 patients enrolled in 5 doses of 5-40 mg/QD, 13 patients (including 3 first-time patients and 10 patients who have previously received anti-VEGF treatment) completed the planned 24-week administration without receiving additional vitreous injections of anti-VEGF drugs; study data showed that the overall population's optimal vision correction (BCVA) improved by an average of more than 5 letters. Among them, the BCVA for 3 first-time patients increased by an average of 12 letters. The above preliminary data shows that HX9428 has good safety characteristics and potential efficacy signals, and its safety and efficacy still need to be verified through further clinical studies. The company will continue to make every effort to advance many clinical studies of HX9428 in China and the US.