HAIXI PHARMA (02637) announced that the U.S. Investigational New Drug (IND) application for its internally developed drug candidate, HX9428, has been approved by the U.S. Food and Drug Administration (FDA). This candidate, derived from the HXP056 project, is designed to treat neovascular age-related macular degeneration (nAMD), also known as wet age-related macular degeneration (wAMD).

The approved IND covers a Phase II clinical trial protocol aimed at evaluating the safety and efficacy of different oral doses of HX9428 in nAMD patients in the United States. Concurrently, HAIXI PHARMA has initiated a second Phase II clinical study in China for HX9428 treating nAMD (registration number: CTR20262884). This study has been registered on the Center for Drug Evaluation (CDE) platform of China's National Medical Products Administration (NMPA).

This new study, designated as protocol HXP056-CTPII-01, is a multi-center, randomized, open-label, active-controlled Phase II clinical trial. It plans to enroll 60 nAMD subjects across multiple clinical research centers in China. The primary objective is to conduct a head-to-head comparison of the efficacy and safety of HX9428 against the standard clinical therapy, Aflibercept.

nAMD is a chronic retinal disease that severely threatens the vision of the elderly. Its key pathological feature is the abnormal formation of choroidal neovascularization, leading to subretinal fluid leakage, bleeding, and vision loss. Currently, anti-vascular endothelial growth factor (anti-VEGF) therapy remains the standard treatment for nAMD. However, existing treatments require intravitreal injections, which can impose significant medical burdens, adherence challenges, and injection-related risks for patients undergoing long-term, repeated therapy.

HX9428 is an oral treatment developed for nAMD, offering excellent convenience of administration compared to traditional injection therapies. This approach can effectively improve long-term patient compliance, address current clinical treatment pain points, and provide a more accessible and convenient option for long-term disease management for nAMD patients.

The FDA approval for the Phase II trial in the U.S. and the initiation of the active-controlled Phase II study in China mark a significant milestone in the global clinical development of HX9428. These steps lay a solid foundation for comprehensively validating the clinical value of HX9428 in treating nAMD.