Circulate the announcement published by our Company on 4 August 2026.：

The board of directors of the Company is pleased to announce that the Investigational New Drug Application (the “IND”) of HX9428, the candidate molecule of HXP056, which was discovered and developed by the Company for the treatment of neovascular age-related macular degeneration ( “nAMD”, also called wet age-related macular degeneration (“wAMD”)), has been approved by the U.S. Food and Drug Administration (the “FDA”). This approved IND includes a Phase II clinical trial, aiming to evaluate the efficacy and safety of different oral doses of HX9428 in treating American patients with nAMD.

At the same time, the Company officially commenced the second Phase II clinical trial of HX9428 (Registration No.: CTR20262884) for the treatment of nAMD in China, and the related information has been published on the Drug Clinical Trial Registration and Information Disclosure Platform of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This study is a randomized and positive-controlled Phase II clinical trial further initiated by the Group based on the prior Phase I and Phase II dose expansion studies of HX9428.

The clinical study (Project No.: HXP056-CTPII-01), a multi-center, randomized, open-label and positive-controlled Phase II clinical trial, plans to recruit 60 nAMD subjects from multiple clinical research centers in China, for the purpose of evaluating the efficacy and safety of HX9428 in a head-to-head comparison with Aflibercept, a standard clinical therapy.

nAMD is a chronic ocular fundus disease that severely threatens the vision of the elderly. Its primary pathological feature is the abnormal formation of choroidal neovascularization, leading to subretinal fluid exudation, hemorrhage and vision decline. Currently, anti-vascular endothelial growth factor (anti-VEGF) therapy remains the standard of care in the treatment of nAMD. However, existing treatments require intravitreal injections, exposing patients to the healthcare burden, adherence challenges and injection-related risks associated with long-term, repeated therapy. HX9428 is an oral therapeutic solution developed for nAMD. Compared to traditional injection therapies, it offers superior ease of administration, effectively improving long-term patient adherence, addressing current clinical pain points and providing a more convenient and accessible new option for long-term disease management in nAMD patients.

The approval of the U.S. FDA Phase II clinical trial IND application and the initiation of the standard-therapy controlled Phase II clinical trial in China mark significant progress in HX9428’s global clinical development and lay a solid foundation for the comprehensive verification of the clinical value of HX9428 in the treatment of nAMD.

The Company will continue to accelerate its global clinical development of HX9428 and will publish updated information on the clinical study when appropriate.

Information on HX9428

HX9428 is an innovative drug candidate discovered and developed by the Company for the treatment of ophthalmic diseases. It is intended for the treatment of fundus neovascularization-related diseases, including nAMD. HX9428 aims to achieve therapeutic intervention in the disease process of nAMD through oral administration. As an innovative oral drug candidate, HX9428 is expected to break through the limitations of current nAMD treatments that rely heavily on intraocular injections. It has the potential to offer patients a more convenient treatment option and further expand long-term disease management models.


Shareholders and/or potential investors of the Company are advised to exercise caution when dealing in the shares of the Company and not to place any excessive reliance on the information disclosed herein. Any shareholder or potential investor who is in doubt is advised to seek advice from professional advisors.