Curocell, a South Korean biotechnology company, is on the verge of launching its CAR-T therapy, Rimqarto (ingredient name: Anbal-cel), for the treatment of relapsed or refractory large B-cell lymphoma (LBCL). This marks a significant milestone as it is poised to become the first domestically developed CAR-T cell therapy in South Korea.
Expedited Approval Process
Rimqarto has been selected by the Ministry of Health and Welfare for expedited approval and market launch through the "Simultaneous Approval-Insurance Evaluation-Drug Price Negotiation" process. This designation aims to accelerate patient access to innovative treatments for severe diseases.
Kim Geon-soo, CEO of Curocell, highlighted the importance of this achievement, noting that CAR-T cell therapy has historically been dominated by the United States and Europe. South Korea joining the ranks of countries with independently developed CAR-T therapies signifies a major advancement in the nation's biotechnology capabilities.
Clinical Efficacy and Manufacturing Advancements
Clinical trials of Rimqarto have shown promising results, with a complete remission rate of 67.1%. Curocell has also established a Good Manufacturing Practice (GMP) facility in Daejeon, which significantly reduces the treatment timeline. Previously, CAR-T cell therapy required sending processed cells to the U.S., taking an average of 40 days. With the local GMP facility, the treatment can now be administered within two weeks.
Orphan Drug Designation and Reimbursement
Rimqarto has received orphan drug designation from the Ministry of Food and Drug Safety (MFDS), which facilitates the rapid development and approval of treatments for rare and life-threatening diseases. This designation provides several benefits, including a 10-year extension of the product license validity and data protection period.
Curocell has also submitted an application to the Health Insurance Review and Assessment Service (HIRA) for reimbursement listing. The reimbursement of Novartis' Kymriah in Korea has set a precedent, raising expectations for Rimqarto's inclusion in the national health insurance system, which would significantly improve treatment accessibility for patients with LBCL.
Future Plans
Curocell is also conducting clinical trials for adult leukemia and plans to expand indications to systemic lupus erythematosus. The company is preparing for global business expansion, exploring opportunities in South America, the Middle East, and Southeast Asia. Additionally, Curocell is developing a treatment for T-cell lymphoma, a project with significant global value due to the lack of existing treatments.
