Curocell said Sept. 4 that its next-generation CAR-T therapy Lymcato (ingredient name: anbalcabtagene autoleucel) was deemed eligible for reimbursement, subject to accepting the assessment price proposed during the Health Insurance Review and Assessment Service’s ninth Drug Reimbursement Evaluation Committee meeting of 2026 held the previous day.
Lymcato is South Korea’s first CAR-T therapy for adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) that have relapsed or failed to respond after two or more lines of systemic treatment.
CAR-T therapy is a personalized cell therapy in which T cells, a type of immune cell, are collected from a patient’s blood, genetically modified to recognize and attack cancer cells, and then infused back into the patient. It is used as a treatment that provides new options for patients with blood cancers that have relapsed or failed to respond to conventional cancer treatments.
Following its product approval from the Ministry of Food and Drug Safety in April and clearance by the Cancer Disease Review Committee in July, Lymcato has now passed another key regulatory hurdle toward ensuring a stable supply of the innovative treatment option to patients in South Korea.
In a Phase 2 clinical trial (CRC01-01), based on an Independent Review Committee (IRC) assessment, Lymcato demonstrated an objective response rate (ORR) of 75.3% and a complete response (CR) rate of 67.1%, demonstrating strong treatment efficacy. It also showed a favorable safety profile, with rates of grade 3 or higher cytokine release syndrome (CRS) and neurotoxicity (NT) of 8.9% and 3.8%, respectively.
In particular, Lymcato is manufactured and supplied directly as a finished drug product at a domestic GMP facility, allowing treatment centers to collect patients’ T cells and send them to Curocell for manufacturing into CAR-T cell therapy without requiring separate cell-processing facilities.
This is expected to enable rapid administration of Lymcato at regional hospitals that previously faced difficulties providing CAR-T treatment due to a lack of dedicated infrastructure, significantly improving access to treatment for patients with relapsed or refractory blood cancers in regional areas who have had to travel elsewhere for care.
Once Curocell officially receives the detailed results of the Drug Reimbursement Evaluation Committee’s review, it plans to carefully examine the conditions presented and promptly proceed with drug price negotiations with the National Health Insurance Service and the resolution process of the Health Insurance Policy Deliberation Committee.
In particular, Lymcato has been moving through a fast-track process after being designated as a Global Innovative Product on Fast Track (GIFT) by the Ministry of Food and Drug Safety and selected for the health authorities’ pilot program for parallel “approval-assessment-negotiation” procedures, raising expectations that the subsequent process will also gain momentum.
Kim Geon-soo, CEO of Curocell, said, “The passage of the Drug Reimbursement Evaluation Committee review is a meaningful achievement that officially recognizes Lymcato’s innovative therapeutic value and technological capabilities. Once we officially receive the detailed review results from HIRA, we will carefully review them internally and respond accordingly.”