HAIXI PHARMA(02637): The wAMD oral drug project HXP056 has completed recruitment for Phase I clinical studies and has initiated Phase II studies.

HAIXI PHARMA (02637) announced that the company's innovative drug project HXP056, is expected to become the world's first oral drug for hemorrhagic retinal diseases. The project started recruiting Chinese wet age-related macular degeneration (wAMD) patients in early July 2025. Recruitment of all patients in the single dose escalation (SAD) and multiple dose escalation (MAD) stages of the first phase clinical trial has been completed, and assessment of dose limiting toxicity (DLT) and pharmacokinetic (PK) data collection have been conducted after four weeks of continuous administration. Preliminary efficacy assessment is also ongoing. In the fourth quarter of 2025, the company also initiated a phase II clinical trial for dose escalation. The human immune system is a complex structure that involves multiple pathways and mechanisms working together. The company's small molecule innovation drug platform (MultiSel-Opt platform) focuses on selectively targeting multiple protein targets to regulate inflammation and immune responses, and fully utilizes the properties of small molecule compounds to achieve synergistic effects through a single drug molecule. The MultiSel-Opt platform enables us to explore innovative mechanisms for disease treatment and achieve core innovation in innovative drug development projects, making the candidate compounds produced incomparable to other drugs in the industry. In addition, another feature of the MultiSel-Opt platform is its focus on optimizing the distribution of drugs at disease sites, such as how to design the best drug compound to achieve appropriate penetration of the blood-retinal barrier (BRB) or blood-brain barrier (BBB). The development of HXP056 is based on the MultiSel-Opt platform, using a single drug with multiple selective mechanisms designed to provide an oral drug to treat hemorrhagic retinal diseases, such as wAMD, diabetic macular edema (DME), and retinal vein occlusion (RVO). HXP056 is expected to overcome multiple technical challenges, achieving BRB penetration to reach the retinal lesion site, while optimizing systemic exposure to ensure patient safety. HXP056 is expected to be the world's first oral drug to treat the above retinal diseases, representing a significant technological breakthrough and explosive global market potential. Preliminary data from the phase I clinical study of HXP056 for wAMD show that the drug has good safety and tolerability, and demonstrates a clear dose-exposure relationship. In addition, preliminary improvements in retinal morphology and function can be observed in wAMD treatment-naive or treated patients participating in the phase I clinical trial. Based on these encouraging preliminary results, the company has begun recruiting patients for the phase II expansion study in China in the fourth quarter of 2025, while the phase I dose escalation study is still ongoing. The company's goal is to rapidly evaluate and determine the optimal treatment dose, laying a solid foundation for the upcoming phase III clinical trial in the near future.