Edding Genor (06998) has announced that its Investigational New Drug application for the Phase Ib/II clinical trial of GB268, a highly differentiated and innovative PD-1/CTLA-4/VEGF trispecific antibody, has been approved by China's National Medical Products Administration.

The trial will investigate GB268 for the treatment of locally advanced unresectable or metastatic breast cancer, including triple-negative breast cancer and hormone receptor-positive/HER2-negative breast cancer.

The NMPA's approval is based on GB268's robust monotherapy clinical data and rational combination therapy mechanisms, demonstrating the candidate's favorable safety profile as a single agent and its potential as a foundational component for comprehensive cancer management.

This indication targets locally advanced unresectable or metastatic breast cancer, exploring monotherapy, immunotherapy combined with chemotherapy, and immunotherapy combined with antibody-drug conjugate regimens, covering the entire course from first-line to subsequent lines of therapy.

This marks the first step in comprehensively expanding the application scope of GB268.

The approval of the clinical trial application signifies the beginning of exploring combination therapies with GB268 as an immunotherapy backbone.

The company also plans to initiate multiple combination therapy clinical studies in additional advanced solid tumor areas in the future.

Currently, the dose escalation study for GB268 has progressed to 30 mg/kg, with no dose-limiting toxicities observed, demonstrating excellent anti-tumor activity and a favorable safety profile.

Monotherapy Phase I clinical data is scheduled for presentation at the European Society for Medical Oncology Congress in the fourth quarter of 2026.