Circulate the announcement published by our Company on 14 July 2026.：
The board of directors of the Company is pleased to announce that the Investigational New Drug (IND) application for HXP089, discovered and developed by the Company, for the treatment of glioblastoma (GBM), has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), permitting the conduct of relevant clinical studies. Following C019199 (oncology indications) and HXP056 (ophthalmology indications), this is the third innovative drug of the Group to enter the clinical trial stage, signifying that the HXP089 project has officially transitioned from preclinical development into the clinical phase and representing a significant milestone for the Company’s MultiSel-Opt innovative R&D platform.
HXP089 is a next-generation selective multi-target small-molecule drug candidate developed by Haixi Pharmaceuticals based on its proprietary small-molecule drug discovery platform — the MultiSel-Opt platform. Adhering to the concept of “delivering synergistic therapeutic effects through multiple mechanisms of action with a single molecule”, HXP089 achieves coordinated modulation of multiple key disease pathways through precise optimization of the molecular structure and possesses strong blood-brain barrier (BBB) penetration capabilities, which is expected to overcome the limitations of traditional single-target drugs in the treatment of glioblastoma. The current standard of care for glioblastoma, which involves surgery combined with chemoradiotherapy, face the challenge of high recurrence rates. Furthermore, there is still an urgent global shortage of effective standard drugs for patients who have relapsed. The development of HXP089 is expected to fill the above shortage and meet the urgent clinical needs of patients worldwide. This approval will support the conduct of relevant clinical studies to evaluate the safety, tolerability and preliminary efficacy profile of HXP089 in the target patients.
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.
