The NMRC for Hematology of the Ministry of Health of the Russian Federation has received a license from the Ministry of Industry and Trade for the production of cellular gene therapy drugs (CAR-T) at its production site. This is the first license, of its kind in Russia, issued by the Ministry of Industry and Trade, for this type of activity.

The license of the Ministry of Industry and Trade makes it possible to start clinical trials of a CAR-T-cell drug developed at the NMRC for Hematology, effective against B-cell tumors carrying the CD19 antigen on their surface. In case of successful completion of clinical trials, registration of the drug and its production are planned not only for the needs of the NMRC for Hematology, but also for other medical institutions.
“The license of the Ministry of Industry and Trade gives us the opportunity to start the registration of clinical trials. In these studies, the efficacy, safety and tolerability of the drug obtained, at a licensed production site, will be confirmed in a sample of patients. Clinical trials are scheduled to be completed by the end of 2025,” says Apollinaria Bogolyubova—Kuznetsova, Head of the Laboratory of Transplantation Immunology of the NMRC for Hematology of the Ministry of Health of the Russian Federation.
In 2024, a production site (“Cleanroom”) was put into operation at the NMRC for Hematology, which ensures compliance at all stages of production of a cellular product with international regulatory standards. The need for anti-CD19 CAR-T cell drugs is high and amounts to about 10,000 patients per year across the country. Indications for the use of CAR-T cell therapy are constantly expanding.
Clinical trials of the anti-CD19 CAR-T cell drug will be conducted within the framework of the state assignment. Currently, only the CAR-T-cell drug,“Kymriah”, of the Swiss company Novartis, is registered in Russia. It is planned that the cost of the NMRC for Hematology drug will be lower than its foreign counterpart. The development of the NMRC for Hematology represents a complete chain from the production of a drug, quality control, administration to patients and tracking of treatment results. This will allow the drug to be used on a routine basis in the future, as well as to discuss possible financial guarantees for the implementation of this therapy. In the future, it is possible to expand production to other CAR-T drugs, which will expand the range of diseases amenable to CAR-T cell therapy.
In addition to the NMRC for Hematology, there are three other organizations in the register of the Ministry of Industry and Trade that have a license to produce gene therapy products. The NMRC for Hematology is the first site that can produce gene therapy products in the form of a cell suspension based on the expertise of the Ministry of Industry and Trade and in accordance with Federal Law No. 61 "On the Circulation of Medicines".
The production line of the new drugs is adapted to the modern realities of the Russian market. The necessary reagents and consumables are manufactured in Russia or are supplied without interruption.
“An incredible team of active, intelligent and knowledgeable people is working on the creation of the production cycle. Considering that this is the first licensing of a cellular gene therapy drug for the country, we had to feel out every step, looking for an opportunity to comply with current legislation and get the drug as we see it. The active licensing phase began in February of this year and only now have we received the coveted expansion of the face-to-face production of medicines. The struggle was worth the fight, although none of us imagined, at first, that it would be this difficult. The NMRC for Hematology team are people who know how to set a task, get it done and not lose heart when something doesn't work out. We do everything necessary and get incredible results,” Apollinaria Bogolyubova-Kuznetsova shared.
Preclinical trials of the proprietary anti-CD19 CAR-T cell drug of the NMRC for Hematology of the Ministry of Health of the Russian Federation were successfully completed in 2023.
Reference. CAR-T-cell therapy drugs are made using the patient's own T-lymphocytes. After sampling the cells are selected and then genetically modified using a viral vector. As a result of this modification, a chimeric antigen receptor (CAR) appears on the surface of T-lymphocytes, which is able to recognize a target on the surface of a cancer cell and selectively destroy it.