Russia’s Health Ministry has granted domestic company Generium permission to conduct a Phase III international multicentre clinical trial of GNR-107, a copy of Amgen’s original drug Vectibix (panitumumab). The medicine is intended for the treatment of metastatic colorectal cancer in adult patients with wild-type RAS tumours. Currently, no registered analogues of this drug exist in Russia. According to analysts, government purchasers bought panitumumab for 4 billion roubles in 2025, an increase of 31% compared with the previous year.
The trial is expected to enrol 250 patients. Generium’s drug and the original Vectibix will be used as second-line therapy in combination with the standard FOLFIRI chemotherapy regimen. Researchers will conduct a comparative assessment of the efficacy, safety and immunogenicity of the two drugs under repeated dosing. The trial authorisation is valid until November 2031.
The trials will be conducted at 29 medical institutions, including Sechenov University, Moscow City Oncology Hospital No. 62, the National Medical Research Centre for Radiology, the Blokhin National Medical Research Centre for Oncology, the Mechnikov North-Western State Medical University and the Medsi hospital group.
Generium received approval for the Phase I clinical trial of GNR-107 in September 2024. The company said that this phase has already been completed.
Panitumumab belongs to the EGFR inhibitor class – a group of targeted drugs for treating non-small cell lung cancer and metastatic colorectal cancer. The original Vectibix has been registered in Russia since 2009 and is included on the list of vital and essential drugs. According to the current registration certificate, packaging and repackaging of the drug may also be carried out at the facilities of Dobrolek (part of the PharmEco Group).
