Quratis’ Rimkato (generic name: anbalcabtagene autoleucel), South Korea’s first domestically developed chimeric antigen receptor T-cell (CAR-T) therapy, has cleared its first hurdle toward national health insurance reimbursement, marking a significant step toward commercial launch later this year.
However, the treatment must still undergo review by the Drug Reimbursement Evaluation Committee and price negotiations with the National Health Insurance Service (NHIS). How much those negotiations reduce the therapy’s multimillion-dollar treatment cost is expected to be the key factor determining final reimbursement.
According to industry sources on July 10, Rimkato recently received reimbursement criteria from the Health Insurance Review and Assessment Service’s (HIRA) Cancer Disease Review Committee, allowing it to move to the next stage of evaluation by the Drug Reimbursement Evaluation Committee.
If the committee completes its review as early as August and pricing negotiations with the NHIS proceed smoothly, the therapy could receive an official reimbursement price in October, paving the way for its first commercial prescriptions. The timing of reimbursement approval is expected to depend largely on the outcome of price negotiations for the high-cost CAR-T therapy.
At its recent meeting, HIRA established reimbursement criteria for Rimkato for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or primary mediastinal large B-cell lymphoma (PMBCL) after two or more lines of systemic therapy.
Rimkato is included in South Korea’s pilot program that allows regulatory approval, reimbursement evaluation and pricing negotiations to proceed simultaneously. The initiative is designed to shorten the time required for reimbursement compared with conventional new drugs.
During a media briefing in May, the company presented September as its best-case launch scenario if all regulatory procedures progressed without delays. However, after one postponement of the Cancer Disease Review Committee meeting, the company is now targeting commercialization before the end of the year.
“A September launch was based on the assumption that every step would proceed without delay,” a Quratis official said. “Because the timeline depends on government procedures, we are now conservatively targeting a launch within this year.”
Rimkato is South Korea’s first domestically developed CAR-T therapy for patients with diffuse large B-cell lymphoma (DLBCL) or primary mediastinal large B-cell lymphoma (PMBCL) whose disease has relapsed or failed to respond to previous treatment.
The personalized cancer immunotherapy works by collecting a patient’s T cells, genetically engineering them to recognize and attack cancer cells, and then reinfusing them into the patient. The therapy received marketing approval from the Ministry of Food and Drug Safety in April, becoming the country’s domestically developed new drug.
Two CAR-T therapies are currently approved in South Korea: Novartis’ Kymriah and Gilead Sciences’ Yescarta. Quratis says Rimkato’s competitive advantage lies in its fully domestic manufacturing process. Using its dedicated CAR-T GMP manufacturing facility in Daejeon, the company handles the entire process—from cell collection and manufacturing to quality control and distribution within South Korea—allowing it to shorten turnaround times compared with imported products.
Commercial launch preparations are also nearing completion. The company plans to begin distribution through 12 major hospitals before expanding to 30 medical institutions nationwide by the end of the year. Because many leading hospitals already offering CAR-T therapy participated in Rimkato’s clinical trials and have experience using the product, the company expects strong adoption, with additional demand anticipated from regional medical centers.
Revenue this year is expected to depend on the timing of reimbursement approval and the final reimbursement price. While the company has not provided specific sales guidance for this year, it aims for annual sales of approximately $60 million once Rimkato is firmly established in the market.