VaizenCell's 'VT-EBV-N' Approved as Korea's First Advanced Regenerative Medicine Treatment
by Park Jeongyeon
Published 24 Apr.2026 13:40(KST)
First Case of Regulatory Sandbox Based on Phase 2 Clinical Results
Actual Patient Administration Before Full Approval... May Influence Conditional Approval
Shares Rally for Third Consecutive Day Amid ASCO Oral Presentation Selection
VaizenCell, a company specializing in new drug development, has announced that its cell therapy product 'VT-EBV-N' will be administered as the first treatment under Korea's Advanced Regenerative Medicine program. With patient administration now possible ahead of full approval based on Phase 2 clinical results, attention is focusing on whether this will impact the conditional approval process.
According to the Ministry of Health and Welfare and industry sources on April 24, the treatment plan for patients with "EBV (Epstein-Barr Virus) positive extra-nodal NK/T-cell lymphoma (ENKL)" submitted by Yeouido St. Mary's Hospital was deemed appropriate by the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Review Committee. This marks the first case nationwide since the launch of the Advanced Regenerative Medicine treatment program in February last year. The substance to be administered in this treatment is VT-EBV-N.
VT-EBV-N is an autologous immune cell therapy in which T-cells extracted from a patient's own blood are cultured and expanded to specifically recognize EBV antigens, then reinfused into the patient. It is administered for maintenance purposes after complete remission is achieved through anti-cancer therapy, in order to eliminate residual cancer cells and prevent relapse. The target disease, ENKL, is a rare and aggressive non-Hodgkin lymphoma of NK cell origin that is closely related to EBV. It has a high recurrence rate after treatment, and the risk of death increases significantly upon relapse.
This approval is the first case achieved through the so-called "planned regulatory sandbox," which allows applications for Advanced Regenerative Medicine treatment plans based on commercial Phase 2 clinical results. The project was selected in July last year, submitted to the review committee in November, and after the first review in January this year, final approval was granted at the fifth review session. The actual treatment will begin following a decision on special regulatory exemptions by the Industrial Convergence Regulatory Special Review Committee. The treatment period will be two years after the committee's approval, with the possibility of extension.
The preceding Phase 2 clinical trial was conducted at Yeouido St. Mary's Hospital from 2017 to 2025 with 48 participants. Based on the results of this Phase 2 trial, VaizenCell plans to apply for expedited review to the Ministry of Food and Drug Safety in the first half of this year and complete its application for conditional approval in the second half.
The results of the Phase 2 study of VT-EBV-N have also been selected for an official oral presentation session at the annual meeting of the American Society of Clinical Oncology (ASCO 2026), to be held in Chicago, United States, from May 29. This marks the first time that a domestic company has been selected for an official oral session at ASCO based on clinical data for a cell therapy product. The presentation will be delivered by Professor Jeon Youngwoo of Yeouido St. Mary's Hospital, who led the clinical study.
VaizenCell's share price has shown strong gains for three consecutive days. Following a 20% surge on April 22 after the announcement of the ASCO oral presentation selection, the stock price reached as high as 11,970 won during trading today. Trading volume reached 97.6 billion won.
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