Haixi New Drug (02637): Hx9428 has completed a phase I clinical study for NAMD treatment, 24 weeks of treatment data observation, phase II dose extension study to obtain phased clinical data

Zhitong Finance App News, Haixi New Pharmaceutical (02637) announced that the Chinese phase I clinical study of HX9428 to treat neovascular age-related macular degeneration (“NaMD”) has completed 24 weeks of treatment data observation; China's phase II dose extension study is still ongoing, and phased clinical data have been obtained.

A total of 15 NAMD patients were included in the Hx9428 Chinese Phase I clinical study, covering five dose groups of 5 mg/QD to 40 mg/QD. Among them, 13 patients completed 24 weeks of treatment, including 10 patients who had previously received anti-vascular endothelial growth factor (anti-VEGF) treatment and 3 first-time patients.

Among the 13 patients who completed 24 weeks of treatment, the best corrected visual acuity (“BCVA”) improved by an average of 5.2 letters from the baseline, and central subfield thickness (central subfield thickness, “CST”) decreased by an average of 73.3 μm from the baseline, indicating an improvement in visual function and macular anatomy indicators.

In terms of safety, no dose-limiting toxicity (dose-limiting toxicity, “DLT” for short) was observed at the five dose levels, and overall tolerability was good. No common gastrointestinal adverse events such as diarrhea, nausea, or vomiting were observed in the study, nor was hair whitening observed. In terms of adverse events related to liver and kidney, an increase in alanine aminotransferase (ALT) and an increase in aspartate aminotransferase (AST) were observed respectively, both grade 1 and transient. Adverse events related to hypertension mainly occurred in the higher dose group. Among them, 1 case of grade 3 adverse event (single systolic pressure 160 mmHg) occurred in the 25 mg/QD dose group and 2 cases of grade 3 adverse events occurred in the 40 mg/QD dose group. Overall, they can be controlled through routine monitoring and antihypertensive treatment. All of the above adverse events occurred within the first 3 months after starting medication; no new adverse events were observed during the 3 to 6 month treatment period.

The HX9428 China Phase II dose extension study is still ongoing. As of August 14, 2026, a total of 80 NAMD patients were enrolled in the 3 dose groups of 5 mg/QD, 10 mg/QD, and 20 mg/QD. Of these, about 78% were patients who had previously received anti-VEGF treatment, and about 22% were first-time patients; 45 patients had completed week 13 visits, and 11 patients had completed 24 weeks of treatment.

The phased data showed that the average BCVA and CST data continued to improve as the time of medication was extended. As of the above date, the 11 patients who completed 24 weeks of treatment had an average improvement of 5.4 letters in BCVA from baseline and an average decrease of 72.5 μm in CST from baseline. The overall efficacy trend was consistent with the results of the phase I study. Due to the limited number of patients who have completed 24 weeks of treatment, the above data is a phased result and still needs to be further verified as the study progresses and the sample size increases.

In terms of safety, overall tolerability is good at this stage, which is basically consistent with the findings of the Phase I study. Common gastrointestinal adverse events such as diarrhea, nausea, and vomiting were not observed in the study, nor was hair whitening observed. Other reported adverse events were mainly low levels, including increased blood pressure and fluctuations in laboratory indicators related to liver, kidney, and metabolism; the incidence of these individual adverse events was less than 10%. The company will continue to monitor various safety indicators and further evaluate the long-term benefit-risk characteristics of HX9428.