Edding Genor announced that China’s National Medical Products Administration (NMPA) approved the company’s Investigational New Drug (IND) application on 9 October 2026, authorising a Phase II clinical trial of GB268 combined with chemotherapy as first-line treatment for locally advanced or metastatic colorectal adenocarcinoma unsuitable for curative surgery or local therapy.

GB268 is a PD-1/CTLA-4/VEGF trispecific antibody designed to modulate the tumour micro-environment by enhancing T-cell infiltration and inhibiting angiogenesis. The upcoming study will specifically target patients with mismatch repair-proficient/microsatellite-stable (pMMR/MSS) tumours, which represent about 95% of advanced colorectal cancer cases and have historically shown limited sensitivity to immunotherapy monotherapy.

The IND approval follows a series of clinical milestones: • July 2025: NMPA cleared a first-in-human Phase I monotherapy trial. Early data from 10 mg/kg to 30 mg/kg cohorts demonstrated favourable safety, tolerability, and preliminary anti-tumour activity. Detailed results are scheduled for presentation at the European Society for Medical Oncology (ESMO) annual meeting in October 2026. • June 2026: The regulator approved a Phase Ib/II study of GB268 in locally advanced unresectable or metastatic breast cancer, including TNBC and HR+/HER2- subtypes. First patient dosing occurred on 5 August 2026.

Edding Genor plans further Phase II evaluations of GB268 as a monotherapy or in combination regimens across multiple solid tumours, such as non-small-cell lung cancer and biliary tract cancer, positioning the asset as a potential broad-spectrum immuno-oncology candidate.

The latest approval provides regulatory validation of Edding Genor’s clinical strategy and supports the acceleration of GB268’s development in high-unmet-need colorectal cancer populations.