[Edaily Reporter KIM JI-WAN ] "Once treatment of the first patient begins, the next steps will be conditional approval, followed by technology export."

With ViGenCell Inc.(308080)’s VT-EBV-N—the first treatment plan in Korea to receive approval for advanced regenerative medicine—now awaiting only follow-up administrative procedures, the company is simultaneously pursuing conditional approval in Korea and technology transfer to China, aiming to become the first successful model of the advanced regenerative medicine era.

According to the company on the 8th, ViGenCell Inc.(308080) ’s VT-EBV-N—a treatment for EBV-positive extranodal NK/T-cell lymphoma—received Korea’s first-ever approval for an advanced regenerative medicine treatment plan. Once the remaining administrative procedures are finalized, treatment administration to the first patients will begin. Currently, four of the 15 eligible patients are already awaiting treatment. Administration is scheduled to begin as soon as the follow-up procedures by the Korea Disease Control and Prevention Agency and the Ministry of Health and Welfare are completed.

ViGenCell Inc.’s VT-EBV-N was approved by the Ministry of Health and Welfare last April as South Korea’s first treatment plan for advanced regenerative medicine. Unlike the conventional method of selling approved drugs, advanced regenerative medicine is a system that allows medical institutions meeting certain requirements to administer treatment to a limited number of patients on a trial basis.

“76 million won is essentially the cost price”… Treatment price recalculated after conditional approval

Currently, the cost of VT-EBV-N treatment is approximately 76.2 million won. Specifically, patients pay 40 million won at the time of treatment and an additional 30 million won if there is no recurrence within five years. If a recurrence occurs within five years, the full treatment cost is refunded.

However, it has been revealed that this pricing is a temporary special offer. It is explained that this cost applies only to the 15 patients covered under the Advanced Biotechnology Act and is effectively at the level of manufacturing costs, with R&D expenses and corporate profits barely factored in.

A representative from ViGenCell Inc. stated, “The current treatment fee is a price set for limited treatment under the Advanced Biotechnology Act,” adding, “We plan to apply for conditional marketing authorization next year, and after approval, the drug will undergo the same pricing calculation process as general pharmaceuticals.” The representative further explained, “We expect the treatment price to be set at a level more than twice as high as the current one after conditional approval.”

The spokesperson said, “Since treatment under the Advanced Therapy Act is focused on providing patients with treatment opportunities rather than for-profit purposes, we set the treatment cost at a level that does not generate a profit.”

The company maintains that a reassessment of treatment costs is inevitable. A representative from ViGenCell Inc. explained, “After collecting T cells from a patient’s blood, we activate them in vitro to recognize the desired antigen or, in some cases, perform gene editing, then culture them for several weeks before re-administering them to the patient,” adding, “Sterility must be maintained at every stage of the manufacturing process, and production must take place in Good Manufacturing Practice (GMP) facilities that meet national standards.”

The representative further emphasized, “Since this is a customized production method in which separate cells are created for each patient, manufacturing and quality control costs are extremely high.”

Domestic Market Alone Could Reach Up to 45 Billion Won Annually; Potential for Technology Export Also Expanding

According to the company and the medical community, the number of EBV-positive NK/T-cell lymphoma patients in South Korea is conservatively estimated at approximately 120 per year, and could be as high as 300. Among these, the high-risk group requiring relapse prevention after complete remission (CR) is the primary target for VT-EBV-N treatment.

ViGenCell Inc. expects the drug price to rise significantly above the current treatment cost under the Advanced Biotechnology Act following conditional marketing approval. Industry sources suggest the treatment cost could be set at approximately 150 million won per patient—roughly double the current level.

Based on this estimate, the domestic market size is projected to range from approximately 18 billion won annually (based on 120 patients) to 45 billion won (based on 300 patients).

VT-EBV-N is moving beyond its approval as the “first product under the Advanced Biotechnology Act” to pursue conditional approval, thereby increasing the likelihood of a technology export (license-out).

A senior official at ViGenCell Inc. stated, “China is one of the countries with a large number of patients with EBV-positive NK/T-cell lymphoma and is a region of high strategic importance in the global market,” adding, “We recently signed a contract with a local business development consulting firm and are actively proceeding with identifying potential partners and negotiating technology transfer agreements.”

EBV-positive extranodal NK/T-cell lymphoma is the most common rare blood cancer in Asia. Its incidence is particularly high in East Asia, including China, South Korea, and Japan. The International T-Cell Lymphoma Project (ITCLP) reported that EBV-positive extranodal NK/T-cell lymphoma accounts for 22.4% of all T/NK-cell lymphomas in Asia, a proportion significantly higher than in North America (5.1%) and Europe (4.3%).

Four-Year Data, Strategy to Prove Efficacy in Preventing Relapse... Increased Likelihood of Conditional Approval

Analysis suggests that, based on sufficient clinical evidence, the likelihood of

conditional approval

is quite high.

VT-EBV-N conducted a randomized, double-blind, placebo-controlled clinical trial at 13 medical institutions in South Korea involving patients with high-risk NK/T-cell lymphoma. This trial design is considered exceptional in the field of rare blood cancers.

Furthermore, the four-year long-term follow-up results presented this year at the American Society of Clinical Oncology (ASCO 2026) supported the conclusion that the treatment’s efficacy is not a temporary phenomenon.

The 4-year disease-free survival (DFS) rate in the VT-EBV-N treatment group remained at 95.0%, unchanged from the 2-year mark. In contrast, the rate in the placebo group decreased from 77.6% to 56.3%. The difference in actual relapse or disease progression was significant, with one case in the treatment group versus seven in the placebo group.

Overall survival (OS) also remained at 100% in the VT-EBV-N group, with no deaths occurring over the 4-year period, whereas the placebo group’s OS dropped to 83.8%, with six deaths occurring during the follow-up period.

Professor Jeon Young-woo of Yeouido St. Mary’s Hospital, The Catholic University of Korea, commented at ASCO, “The key is not what to do after a relapse, but ensuring that relapse does not occur once complete remission is achieved,” adding, “This study demonstrated the potential for relapse prevention strategies to remain effective even during long-term follow-up.”