21.07.2025
Roszdravnadzor has issued a license to the NMRC for Hematology, permitting the production of biomedical cell products (BMCP), including personalized BMCP. These include CAR T-cell products manufactured and used within the walls of the National Medical Research Center for Hematology outside of clinical trials and routine application. “We are making great strides in treating patients in all the diversity of regulatory and legal regulation within our country. Now, the NMRC for Hematology is the first and so far the only center in the country to possess all the necessary licenses for the production of CAR
T-cell products. This includes a license from the Ministry of Industry and Trade of the Russian Federation, which we received in September 2024, and a license from Roszdravnadzor, which we obtained in June 2025,” said Apollinaria Bogolyubova—Kuznetsova, Head of the Management Division of Biomedical Technologies, Head of the Laboratory of Translational Immunology at the NMRC for Hematology. “This is especially important for patients in need of treatment under hospital exemption, meaning within the framework of individualized medical prescriptions. We are not just talking about the anti-CD19 CAR T-cell drug. We are developing a range of cell-based drugs that can be used under the new license. And the fact that the NMRC for Hematology has obtained it is a crucial step toward enabling experimental, unique, non–standard and rare treatment options,” she added.
Confirmation of Compliance with Strict Standards
“By issuing a license, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) confirms that the production facilities and documentation developed at the NMRC for Hematology of the Ministry of Health of the Russian Federation meet the requirements for the production of biomedical cell products,” said Dinara Barakova, Head of the Division of Technological Control at the NMRC for Hematology. “The license allows for a broader application of CAR T-cell products, including under hospital exemption.”
Hospital Exemption: A Chance for “Rare” Patients
“Hospital exemption is a special legal mechanism that allows the use of unregistered treatment methods in exceptional cases. As a rule, it is used when the patient has exhausted all standard treatment options. The decision for such treatment is made by a medical council after a thorough analysis of the situation, taking into account the data on the high efficacy of the method for a specific clinical case,” explained Olga Aleshina, Head of the Division of Cellular and Immune Therapy at the NMRC for Hematology. “This is especially important for patients who cannot participate in clinical trials due to strict selection criteria- for example, those with comorbidities or an unusual disease course. The obtained license legally enables us to use advanced treatments, including CAR-T therapy, for such complex cases without being limited to clinical trial frameworks. Essentially, this is a life-saving opportunity for patients who simply have no other options left.”
In early July 2025, it was reported that the first 30 out of 60 patients had already received the experimental drug “Utzhefra” as part of Russia's first clinical trial of a domestic CAR T-cell drug for the treatment of B-cell malignant blood neoplasms. The innovative cell-based drug is used to treat patients with relapses and refractory forms of the disease, meaning those resistant to therapy. The main condition for inclusion in the clinical trial is the presence of the CD19 antigen on the surface of tumor cells. Clinical trials are set to be completed by the end of 2025, after which the drug is expected to be registered. The efforts to establish the technological production process for the cell-based drug were supported by the Scientific Center for Advanced Interdisciplinary Research “Idea” (http://scientificideas.org/), which provided equipment and supplies for transferring the production technology to GMP conditions and conducting scientific research.
