Haixi New Pharmaceutical (02637): HX9428 was approved by the US FDA IND to start a phase II clinical trial to treat neovascularization age-related macular degeneration while initiating a second phase II clinical trial using positive controls in China

According to Zhitong Finance App News, Haixi New Pharmaceutical (02637) announced that the US clinical trial application (IND) for the drug candidate HXP056 of the innovative drug project HXP056 developed by the company has been approved by the US Food and Drug Administration (FDA) for treating neovascular age-related macular degeneration (“NaMD” for short), also known as wet age-related macular degeneration (WAMd). The approved IND covers a phase II clinical trial protocol aimed at evaluating the efficacy and safety of different oral doses of HX9428 in patients with NaMD in the US.

At the same time, the company has officially launched the second phase II clinical study on Hx9428 for NAMD treatment in China (registration number: CTR20262884), and the relevant information has been published by the China National Drug Administration (NMPA) Drug Evaluation Center (CDE) drug clinical trial registration and information disclosure platform. This study is a randomized, positive-controlled phase II clinical study initiated by the Group on the basis of HX9428's previous phase I and phase II dose extension studies.

This clinical study (protocol number: HXP056-CTPII-01) is a multi-center, randomized, open, positive-controlled phase II clinical study. It is planned to recruit 60 NaMD subjects at multiple clinical research centers in China to evaluate the efficacy and safety of HX9428 and the clinical standard therapy drug Aflibercept (Aflibercept) in a head-to-head comparison.

NaMD is a chronic fundus disease that seriously threatens the eyesight of the elderly. Its main pathological characteristic is abnormal formation of choroidal neovascularization, leading to subretinal fluid exudation, bleeding, and vision loss. Currently, anti-vascular endothelial growth factor (anti-VEGF) treatment is still the standard treatment for NaMD. However, current treatments require intravitreal injections, and patients may face medical burdens, compliance challenges, and injection-related risks associated with long-term and repeated treatments. Hx9428 is an oral treatment plan developed for NaMD. Compared with traditional injection therapy, it has excellent ease of administration, can effectively improve patients' long-term treatment compliance, solve existing clinical treatment pain points, and provide NaMD patients with new options for more convenient and accessible long-term disease management.

The approval of the FDAII clinical trial in the US and the launch of the phase II clinical trial against standard therapy in China mark important progress in the global clinical development process of HX9428 and lay a solid foundation for comprehensively verifying the clinical value of Hx9428 in NAMD treatment.