Ministry of Food and Drug Safety Approves CureCell's LIMCARTO... Korea's First CAR-T Therapy

Qurosell's chimeric antigen receptor (CAR) T-cell therapy, "LIMCARTO," has received regulatory approval. This marks the first approval of a CAR-T therapy in Korea.

Exterior view of Qurosell headquarters in Yuseong District, Daejeon. Qurosell

원본보기 아이콘

On April 30, the Ministry of Food and Drug Safety announced it has authorized Qurosell's "LIMCARTO (AnbalcaptaGene Autoleucel)," the country's first CAR-T therapy. CAR-T therapies are customized gene therapies that genetically modify a patient's immune cells to precisely target and attack cancer cells.

LIMCARTO is an orphan drug indicated for adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma who have relapsed or are refractory (unresponsive) after two or more systemic treatments. Among lymphomas, DLBCL is the most common type, and primary mediastinal B-cell lymphoma is a subtype, accounting for up to 10% of DLBCL cases.

This drug works by inserting genetic information into the patient's immune cells (T cells) so they can recognize the B-cell surface antigen protein "CD19." The modified cells are then re-infused into the patient, where they identify and destroy cancer cells expressing CD19. The therapy also inhibits the expression of certain receptors that regulate immune responses to prevent cancer cells from escaping the immune system, and it enhances efficacy by promoting the persistence of T-cell responses.

Qurosell previously reported that, in Phase 2 clinical trials, the complete remission rate-the proportion of patients whose cancer cells disappeared-was 67.1%, demonstrating outstanding efficacy. This is known to be higher than other existing therapies such as Kymriah. The therapy also received positive safety evaluations. In February last year, Qurosell submitted a drug reimbursement evaluation application to the Health Insurance Review & Assessment Service (HIRA) to have LIMCARTO covered by the national health insurance.

Although CAR-T therapies are high-cost treatments, imported products like Kymriah are already covered by health insurance. At the time of the reimbursement application last year, Qurosell CEO Kim Geonsu stated, "We will do our utmost to provide innovative treatment options for patients and ensure that more patients can benefit from LIMCARTO."

Earlier, the Ministry of Food and Drug Safety designated this medicine as a Bio Challenger item and as the 33rd product under the Global Innovative Product Fast-Track (GIFT) system, supporting commercialization from the early development stage through customized consultations and expedited review.

© The Asia Business Daily(www.asiae.co.kr). All rights reserved.