Shanghai，China，July 2，Edding Genor Group Holdings Limited（"Edding Genor",HKEX: 6998）announced the Investigational New Drug ("IND") application for the Phase Ib/II clinical trial of GB268, the Company's highly differentiated and innovative PD-1/CTLA-4/VEGF trispecific antibody, for the treatment of locally advanced unresectable or metastatic breast cancer (including triple-negative breast cancer and hormone receptor-positive/HER2-negative breast cancer) has been approved by the National Medical Products Administration of China ("NMPA").
The NMPA's approval of this IND was based on the robust monotherapy clinical data and the rational combination mechanism of GB268, demonstrating the favorable safety profile of GB268 as a monotherapy and its potential as a cornerstone in the holistic management of malignant tumors.
The indication focuses on locally advanced unresectable or metastatic breast cancer, exploring monotherapy, immunotherapy combined with chemotherapy, and immunotherapy combined with antibody-drug conjugate regimens across first-line and later-line treatment stages, marking the first step in comprehensively expanding the application scope of GB268.
The approval of clinical trial application represents the beginning of exploring combination regimens based on GB268 as an immunotherapy backbone. In the future, the Company also expects to initiate multiple combination therapy clinical studies in additional advanced solid tumor indications.
Currently, the dose-escalation study of GB268 has escalated to 30 mg/kg without dose-limiting toxicity, demonstrating excellent anti-tumor activity and a favorable safety profile. Phase I monotherapy clinical data is expected to be presented at the European Society for Medical Oncology congress in fourth quarter of 2026.
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