"End of Foreign Dependence"... Korea's First CAR-T Therapy 'Rimkato' Set for Insurance Coverage Launch in September

Korea's 42nd New Drug 'Rimkato' Accelerates Commercialization
53% Lower Risk of Death Compared to Global CAR-T Therapies
Expansion of Indications Planned for Adult ALL and Lupus

"This approval of Rimkato goes beyond the simple entry of a new drug into the market. It is highly significant as it demonstrates that advanced cell therapies can be independently developed and commercialized in Korea."

Kim Gunsu, CEO of Curecell, made this statement at a press conference held at the Four Seasons Hotel Seoul on the 14th, adding, "We aim to become a globally competitive company by leveraging the research & development and manufacturing capabilities we have built up domestically." Curecell specializes in developing anti-cancer cell therapy products utilizing immune cells.

Kim Gunsoo, CEO of Curecell, delivers a welcoming speech at a press conference held on the morning of the 14th at the Four Seasons Hotel Seoul. Curecell

CAR-T therapies are next-generation cell therapies in which a patient’s T cells are extracted, genetically modified to attack cancer cells, and then reinfused. They have drawn attention for offering new treatment opportunities to patients with relapsed or refractory hematologic cancers who do not respond to existing anti-cancer therapies. However, due to the complexity of the manufacturing process and a reliance on overseas production, access for domestic patients has been limited. CEO Kim explained, "We have focused all our capabilities on improving manufacturing, supply, and accessibility to lower the barriers for our patients to receive actual treatment in a CAR-T environment that has long been dependent on foreign sources."

Rimkato (ingredient name: Anbalcaptaagen Autoluicel), developed by Curecell, received official manufacturing and sales approval from the Ministry of Food and Drug Safety on April 29. It is the 42nd domestically developed new drug and the first CAR-T therapy developed by a Korean company. It is intended for adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have relapsed or are refractory after two or more lines of systemic therapy.

The therapy has also proven its competitiveness in clinical results. At the press conference, Professor Kim Wonseok of the Department of Hematology-Oncology at Samsung Seoul Hospital stated, "In phase 2 clinical trials, Rimkato achieved an objective response rate (ORR) of 75.3% and a complete remission rate (CR) of 67.1%." He added, "According to a matching-adjusted indirect comparison (MAIC) with existing global CAR-T therapies, Rimkato significantly reduced the risk of death by 53% compared to current commercial products in terms of overall survival (OS)." The incidence of adverse events was also relatively low, with grade 3 or higher cytokine release syndrome (CRS) occurring in 8.9% of cases and neurotoxicity (NE) in 3.8%, both lower than global products.

(From left) Seungwon Lee, Executive Director of Curecell; Geonsu Kim, CEO; Wonseok Kim, Professor of Hematology-Oncology at Samsung Seoul Hospital; and Soohui Cho, Head of the Clinical Development Center, are making a presentation at the press conference held on the 14th at the Four Seasons Hotel in Gwanghwamun, Seoul. Curecell

Rimkato has been selected for the Ministry of Health and Welfare's pilot project, which allows simultaneous approval, assessment, and reimbursement negotiations, so the health insurance reimbursement registration process is proceeding in parallel with regulatory approval. While it typically takes around 18 months from new drug approval to insurance reimbursement, the pilot project enables this period to be shortened by about 90 days. Curecell is aiming for reimbursement-based market launch in September. Seungwon Lee, Executive Director of Curecell, said, "By performing the entire process in-house at Korea’s largest GMP (Good Manufacturing Practice) facility dedicated to CAR-T in Daejeon, we can shorten manufacturing and supply times compared to overseas production and ensure stable supply." He continued, "We are currently onboarding with 12 hospitals, including major general hospitals in Seoul, and plan to expand treatment centers to 30 medical institutions nationwide within the year." Another strength is the elimination of overseas transportation risks through a domestic cold-chain delivery system, and the ability to introduce the therapy to various medical institutions without the need for cell-freezing facilities.

Curecell has presented a stepwise roadmap for expanding indications by 2030 based on its proprietary OVIS™ platform technology (simultaneous inhibition of PD-1 and TIGIT). Suhee Cho, Director of the Clinical Development Center at Curecell, stated, "Phase 1 clinical trials for adult acute lymphoblastic leukemia (ALL) are nearing completion, and this is particularly meaningful as it is the first CAR-T clinical trial for adults in Korea." She added, "We have also obtained the country's first clinical trial approval in the area of systemic lupus erythematosus (SLE), an autoimmune disease, and are accumulating real-world treatment experience through compassionate use approvals."

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