Biocad received a clinical trial authorization for its original medicinal product in the EU. The company starts the clinical trial “DOMAJOR” in Slovakia of the drug prolgolimab in treatment of non small cell lung cancer. The company intends to invest over 25 million euro in this clinical development and launch the product in China and the EU.
The authorization to conduct the clinical trial in Slovakia was the first in the EU. “So far, it’s only Slovakia, but we have received a first confirmation that the huge work on the development of the drug in accordance with ICH recommendations was not in vain. I’m sure that soon the authorization to conduct CI of this Russian drug in other EU countries will follow.” said Roman Ivanov, Vice President for Development and Research at Biocad.
292 patients will be recruited in the Study within a period of 12 months in the European Union, the Russian Federation, and the People's Republic of China. It is predicted that Hungary will become the next country in the European Union ready to issue the authorization to conduct this clinical trial already in October.