EDDING GENOR (06998.HK): GB268 Colorectal Cancer Phase II IND Approved
- The approved indication is advanced colorectal cancer, including unresectable locally advanced and metastatic colorectal cancer, of which the pMMR/MSS type accounts for about 95% and is recognised as insensitive to single-agent immunotherapy.
- GB268 received first-in-human clinical trial approval from the NMPA in July 2025; preliminary Phase I data across the 10mg/kg to 30mg/kg monotherapy cohorts showed good safety and tolerability, favourable PK/PD data and antitumour activity in all dose cohorts.
- GB268 received NMPA Phase Ib/II clinical trial approval in June 2026 for locally advanced unresectable or metastatic breast cancer, with the first patient dosed on 5 August 2026.
NewTimeSpace News: On 11 October 2026, Edding Genor Group Holdings Limited (stock code: 06998) announced that the Phase II investigational new drug (IND) application for GB268, its highly differentiated PD-1/CTLA-4/VEGF trispecific antibody, in combination with chemotherapy as first-line treatment of locally advanced or metastatic colorectal adenocarcinoma, was approved by China's National Medical Products Administration (NMPA) on 9 October 2026.
The approved indication 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 about 95% and is recognised as insensitive to single-agent immunotherapy. By finely modulating the three arms of PD-1/CTLA-4/VEGF activity, GB268 improves the tumour immune microenvironment, promotes T-cell infiltration and inhibits angiogenesis, and the combination regimen may reshape first-line treatment for pMMR/MSS advanced colorectal cancer.
GB268 obtained its first-in-human clinical trial approval from the NMPA in July 2025, and preliminary data from the 10mg/kg to 30mg/kg dose cohorts in the monotherapy Phase I study showed good safety and tolerability and favourable PK/PD data, with antitumour activity observed in all dose cohorts.
