Curocell’s Rimqarto, South Korea’s First Homegrown CAR-T, Clears Initial Hurdle for National Health Insurance Reimbursement

KBR (Korea Biomedical Review) South Korea

Overview

Curocell’s Rimqarto (anbalcabtagene autoleucel), South Korea’s first domestically developed CAR-T cell therapy, has successfully cleared its initial major step towards national health insurance reimbursement. The Ministry of Health and Welfare’s Cancer Review Committee determined that reimbursement criteria for Rimqarto could be established. This decision brings Rimqarto, which received marketing approval in April, closer to reimbursement approval and commercial launch later this year, potentially significantly improving access to cell therapy in South Korea.

In Depth

Key Findings: South Korea’s First CAR-T Therapy, Rimqarto, Advances Towards Reimbursement

Curocell’s Rimqarto (anbalcabtagene autoleucel), the first CAR-T cell therapy developed domestically in South Korea, has cleared a critical initial phase towards national health insurance (NHI) reimbursement. The Cancer Review Committee, under the Ministry of Health and Welfare, concluded that Rimqarto meets the criteria for health insurance reimbursement and that such criteria can be established. This decision follows the product’s marketing approval by the Ministry of Food and Drug Safety (MFDS) in April, significantly paving the way for Rimqarto’s commercialization.

Clinical and Regulatory Details: Hope for Patients with Refractory Hematologic Cancers

Rimqarto targets patients with refractory hematologic cancers, such as diffuse large B-cell lymphoma (DLBCL), who have failed existing treatments. CAR-T cell therapy is a form of personalized medicine where a patient’s own T-cells are genetically engineered to target and attack cancer cells, then re-infused. It has demonstrated remarkable efficacy in severe hematological malignancies globally. While foreign-made CAR-T therapies have been available in South Korea, the progress of Rimqarto’s domestic development, approval, and movement towards reimbursement means that Korean patients could gain faster and potentially more cost-effective access to this advanced treatment. The Cancer Review Committee’s positive assessment is a result of Rimqarto’s clinical utility and safety being evaluated within the Korean healthcare system, with future reimbursement price negotiations and final insurance coverage pending.

Background and Industry Context: Strengthening the Domestic Cell Therapy Ecosystem

The advancement of Curocell’s Rimqarto underscores the growing technological capabilities and regulatory responsiveness within South Korea’s biotechnology industry, particularly in the cell and gene therapy (CGT) sector. Previously, high costs limited CAR-T therapy access to a small patient population. With the domestic manufacturing and development of Rimqarto poised for reimbursement, more patients can access this innovative treatment, contributing to the overall revitalization of South Korea’s CGT ecosystem. This move aligns with the Korean government’s policy to nurture the biopharmaceutical industry as a national strategic sector, enhancing the attractiveness of the Korean market for both domestic and international investors and companies.

Future Outlook: Commercial Launch and Market Impact Later This Year

Following the Cancer Review Committee’s decision, Curocell will proceed with price negotiations with the Health Insurance Review and Assessment Service (HIRA) and seek final approval from the Ministry of Health and Welfare’s drug pricing policy deliberation committee to achieve insurance coverage and commercial launch for Rimqarto. If these processes proceed smoothly, a full-scale commercial launch in the Korean market is expected in the latter half of the year. Rimqarto’s market entry is anticipated not only to compete with existing treatments but also to drive growth in the overall Korean cell therapy market, positively impacting other domestic CGT developers. In the long term, accumulating clinical evidence for Rimqarto could potentially lead to expanded indications and serve as a stepping stone for regulatory submissions in other countries.

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