Qurucell's Limcato Clears PREC Review, Speeds Up Health Insurance Reimbursement This Year

Recognized for Reimbursement Suitability with Conditional Price Acceptance
Price Negotiations with National Health Insurance and HIPRC Procedures Remain

Qurucell's CAR-T therapy, Limcato (ingredient name: Anbalcaptagene autoleucel), has passed a key hurdle toward securing coverage under the national health insurance program.

On September 4, Qurucell announced that Limcato had been recognized for reimbursement suitability, conditional on accepting the proposed price presented at the 9th Pharmaceutical Reimbursement Evaluation Committee (PREC) meeting of the Health Insurance Review and Assessment Service (HIRA) held on September 3, 2026.

Quracell company logo image. Quracell

Limcato is a CAR-T therapy indicated for adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) whose disease has relapsed or not responded after at least two prior systemic therapies. The product received item approval from the Ministry of Food and Drug Safety in April 2026, passed the Cancer Disease Review Committee (CDRC) in July, and has now cleared the PREC review.

In phase 2 clinical trial (CRC01-01), the objective response rate (ORR) according to Independent Review Committee (IRC) criteria was 75.3%, and the complete response rate (CR) was 67.1%. The incidence of grade 3 or higher cytokine release syndrome (CRS) was 8.9%, and neurotoxicity (NE) occurred in 3.8% of patients. These clinical results were published in the international journal "Blood".

Limcato is manufactured at a domestic GMP facility by using T-cells collected from the patient, allowing production as a CAR-T therapy. According to the company, this means treatment centers do not need to have separate cell processing facilities, thereby improving patient access in regional hub hospitals.

Qurucell stated that, once it receives the official PREC review results, it will review the detailed conditions and proceed with price negotiations with the National Health Insurance Service. Reimbursement listing will be finalized following the decision by the Health Insurance Policy Review Committee (HIPRC).

Limcato has also been designated for the Ministry of Food and Drug Safety's Global Innovative Fast Track (GIFT), and was selected as a target product for the "concurrent approval-review-negotiation pilot program," moving through the related procedures. Qurucell plans to carry out subsequent steps with the goal of securing health insurance coverage within this year.

Qurucell CEO Kim Geonsu said, "This PREC approval is a meaningful achievement that recognizes the therapeutic value and technological capability of Limcato. As soon as we receive the official detailed review results from HIRA, we will conduct internal review and do our utmost to advance the process."

This content was produced with the assistance of AI translation services.