The company's self-developed HXP089 project, intended for the treatment of glioblastoma (GBM), has received approval for its Investigational New Drug (IND) application from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), granting permission to proceed with related clinical studies.

This marks the third innovative drug from the group to enter the clinical trial stage, following C019199 (for oncology indications) and HXP056 (for ophthalmic indications). It signifies the HXP089 project's official transition from preclinical development into the clinical phase and represents a significant milestone for the company's MultiSel Opt innovative R&D platform.

HXP089 is a new-generation chemical small molecule selective multi-target innovative drug developed by HAIXI PHARMA (ASX: 02637) based on its proprietary MultiSel-Opt platform. The project adheres to the concept of "using a single drug molecule to achieve synergistic treatment through multiple mechanisms of action." It aims to achieve coordinated regulation of multiple key disease pathways through precise optimization of the drug molecule's structure and possesses a strong ability to cross the blood-brain barrier (BBB), potentially overcoming the limitations of traditional single-target drugs in glioblastoma treatment.

Currently, the standard treatment regimen for glioblastoma (surgery combined with radiotherapy and chemotherapy) faces the challenge of high recurrence rates. For patients facing recurrence, there remains a global urgent shortage of effective standard therapeutic drugs. The development of HXP089 holds promise to address this treatment gap and meet the urgent clinical needs of patients worldwide.

This approval will support the conduct of related clinical studies to evaluate the safety, tolerability, and preliminary efficacy profile of HXP089 in the target patient population.