Qurocell's CAR-T Therapy 'Limkato' Passes Cancer Drug Deliberation Committee... Reimbursement and Launch Expected in Second Half
Health Insurance Review and Assessment Service Committee Approves Reimbursement Standards
Selected for Simultaneous Approval-Evaluation-Negotiation Pilot Project; Reimbursement Registration to Accelerate
Full-Scale Health Insurance Coverage and Commercialization Expected in Second Half of the Year
CAR-T therapy specialist Qurocell announced on July 9 that Limkato (ingredient name: Anbalcapta-gene autoleucel), the first CAR-T therapy to be developed in Korea, has passed the sixth deliberation committee for severe diseases (Cancer Drug Deliberation Committee) of the Health Insurance Review and Assessment Service.
Limkato received a resolution at the Cancer Drug Deliberation Committee meeting held on July 8 stating that it is suitable for the establishment of health insurance reimbursement standards. Following product approval in April, the company expects that the reimbursement registration process will accelerate with this latest committee approval.
Limkato is designated as a target product for the Ministry of Health and Welfare's "Simultaneous Approval-Evaluation-Negotiation Pilot Project." As a result, the reimbursement registration period may be shortened compared to general pharmaceuticals, and the company expects that subsequent procedures, such as the Drug Reimbursement Evaluation Committee deliberation and price negotiations, will proceed quickly.
Limkato is a CAR-T therapy indicated for patients with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory after two or more lines of systemic therapy. In phase 2 clinical trials, it achieved a complete response (CR) rate of 67.1% and an objective response rate (ORR) of 75.3%. The incidence of grade 3 or higher severe cytokine release syndrome (CRS) was 8.9%, and the incidence of severe neurotoxicity (NE) was 3.8%.
Qurocell explained that it has established a GMP manufacturing facility dedicated to CAR-T therapy in Daejeon, enabling a production system that can shorten the turnaround time (TAT) from patient blood collection to therapy supply. The company plans to expand treatment centers to 30 medical institutions nationwide within this year.
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Geonsoo Kim, CEO of Qurocell, stated, "With both product approval and the Cancer Drug Deliberation Committee approval, key procedures for commercialization are progressing smoothly. We will complete the remaining Drug Reimbursement Evaluation Committee review and price negotiations to ensure health insurance coverage and patient treatment in the second half of this year."
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