According to Zhitong Finance App, Haixi New Pharmaceutical (02637) announced that the HXP089 project developed independently by the company has obtained approval from the National Drug Administration (NMPA) Drug Evaluation Center (CDE) for the treatment of Glioblastoma (GBM). This is the Group's third innovative drug to enter clinical trials after C019199 (oncological indications) and HXP056 (ophthalmology indications). It marks the official transition of the HXP089 project from pre-clinical development to the clinical stage. It is also an important milestone in the company's MultiSel Opt innovative R&D platform.
HXP089 is a next-generation chemical-small-molecule selective multi-target innovative drug developed by Haixi Pharmaceutical based on the MultiSel-opt platform, an independently innovative small-molecule drug development platform. The project implements the concept of “using a single drug molecule to achieve collaborative treatment with multiple mechanisms of action”, realizes collaborative regulation of multiple key disease pathways through accurate optimization of drug molecular structures, and has good ability to pass through the blood-brain barrier (BBB), which is expected to break through the limitations of traditional single-target drugs in glioblastoma treatment. Currently, the standard treatment plan for glioblastoma (surgery combined with chemoradiotherapy) faces the challenge of a high recurrence rate, and there is still a global shortage of effective standard treatments for patients after recurrence. The development of HXP089 is expected to solve these treatment gaps and meet the urgent clinical needs of patients around the world. This approval will support relevant clinical studies to evaluate the safety, tolerability and initial efficacy characteristics of HXP089 in target patients.