EDDING GENOR (06998): IND for Phase II clinical trial of GB268 for colorectal cancer approved by the National Medical Products Administration

EDDING GENOR (06998) announced that the Company's highly differentiated and innovative PD-1/CTLA-4/VEGF trispecific antibody GB268, in combination with chemotherapy as first-line treatment for locally advanced or metastatic colorectal adenocarcinoma that is not amenable to radical surgical resection or local therapy, has had its Phase II Investigational New Drug (IND) application approved by China's National Medical Products Administration (NMPA) on October 9, 2026. This progress marks the initial regulatory recognition of GB268's clinical development plan and lays a solid foundation for the Company's subsequent advancement of this clinical trial. The indication approved under this IND is advanced colorectal cancer, including unresectable locally advanced and metastatic colorectal cancer, of which the mismatch repair-proficient/microsatellite stable (pMMR/MSS) type accounts for approximately 95% of this population and is recognized as a tumor insensitive to single-agent immunotherapy, while the efficacy improvement of traditional chemotherapy and targeted drugs has entered a plateau. Developing new treatment strategies that improve efficacy, prolong survival, and have manageable toxicity to improve survival outcomes for patients with pMMR/MSS advanced colorectal cancer has become an urgent current clinical need. The GB268 trispecific antibody, through fine regulation of its PD-1/CTLA-4/VEGF three-arm activity, improves the tumor immune microenvironment, promotes T cell infiltration, and inhibits angiogenesis, demonstrating the potential to break through the immune barrier in pMMR/MSS advanced colorectal cancer, and the combination chemotherapy regimen is expected to reshape the first-line treatment landscape for pMMR/MSS advanced colorectal cancer. GB268 received its first-in-human clinical trial approval from the NMPA in July 2025. Preliminary data from the monotherapy Phase I clinical study at dose groups of 10mg/kg to 30mg/kg showed good safety and tolerability, excellent PK/PD data, and antitumor activity was observed in all dose groups. The relevant clinical data are expected to be presented at the European Society for Medical Oncology (ESMO) Annual Congress in October 2026. GB268 received NMPA approval for a Phase Ib/II clinical trial in June 2026 for the treatment of locally advanced unresectable or metastatic breast cancer (including triple-negative breast cancer [TNBC] and hormone receptor-positive/HER2-negative [HR+/HER2-] breast cancer), exploring monotherapy, immuno-chemotherapy combination, and immuno-antibody-drug conjugate combination regimens, and successfully completed first patient dosing on August 5, 2026. GB268 is expected to be developed in Phase II clinical studies as monotherapy or in combination therapy across multiple solid tumors, including but not limited to advanced breast cancer, non-small cell lung cancer, colorectal cancer, biliary tract cancer, and other solid tumors.