ViGenCell's VT-EBV-N Becomes First Advanced Regenerative Medicine Treatment in South Korea

[Financial News] South Korea's first advanced regenerative medicine treatment using ViGenCell's cell therapy VT-EBV-N is set to begin.
ViGenCell, a company specializing in new drug development, said on the 1st that advanced regenerative medicine treatment using VT-EBV-N will begin in earnest at The Catholic University of Korea, Yeouido St. Mary's Hospital.
The treatment was applied for by Yeouido St. Mary's Hospital and approved by the Ministry of Health and Welfare (MOHW) in April. It is the first advanced regenerative medicine treatment approved since the system took effect in February 2025.
The treatment will run for the next two years and will involve 15 patients in complete remission from EBV-positive extranodal NK/T-cell lymphoma who face a high risk of recurrence. ViGenCell will handle the manufacturing and supply of VT-EBV-N used in the treatment.
The treatment was advanced through a planned regulatory sandbox. Under the regulatory exception, the company used the results of ViGenCell's commercial clinical trial, approved by the Ministry of Food and Drug Safety, as the basis for assessing the safety and efficacy of the treatment plan. This is the first case in which clinical trial evidence for a drug under the Ministry of Food and Drug Safety was linked to advanced regenerative medicine treatment under the MOHW.
ViGenCell also secured the manufacturing and supply infrastructure needed for the treatment by obtaining approval in December 2024 for the cell processing facility at its advanced biopharmaceutical GMP center, the V-Cell Center.
VT-EBV-N is an autologous, blood-derived antigen-specific T-cell therapy that recognizes key EBV antigens. In a phase 2 trial, it met its primary endpoint by improving the two-year disease-free survival rate. In four-year follow-up data released at ASCO 2026 in May, overall survival remained at 100% and disease-free survival at 95.0%.
Through this treatment, ViGenCell plans to gather additional real-world clinical data and verify its supply capabilities across the full process, from patient enrollment to cell manufacturing, quality control, and delivery, in preparation for future expansion of the therapy.
Ki Pyeong-seok, CEO of ViGenCell, said, "We expect this to draw renewed attention to the value of VT-EBV-N, which has shown relapse-suppressing effects in long-term follow-up data." He added, "We will do our utmost to ensure stable manufacturing and supply in cooperation with Yeouido St. Mary's Hospital and government agencies."

[email protected] Jung Sang-hee Reporter