Curocell's "Limcato" (ingredient name Anbalcaptagene autoleucel), Korea's first chimeric antigen receptor T-cell (CAR-T) therapy, got the green light for commercialization in the second half.
According to the company on the 9th, Limcato was resolved as suitable for setting reimbursement criteria based on the deliberation results of the Severe Disease Review Committee (Cancer Drug Review Committee) of the Health Insurance Review & Assessment Service (HIRA) held the previous day.
Limcato received marketing authorization in April from the Ministery of Food and Drug Safety as a treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The Cancer Drug Review Committee is the first key body that decides whether specialized medicines, such as anticancer drugs and treatments for rare diseases, are covered by health insurance. With this approval, Limcato has laid the groundwork for clinical utility and reimbursement appropriateness.
In particular, Limcato was selected for the Ministry of Health and Welfare's pilot program of concurrent authorization–assessment–negotiation, significantly shortening the reimbursement listing period compared with general drugs. As early as the second half of this year, the final reimbursement notice and actual prescriptions are expected. The company expects second-half commercialization results and visible revenue realization.
Limcato is a therapy for patients with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory after two or more lines of systemic therapy. In a phase 2 trial, it recorded a complete response (CR) rate of 67.1%, the proportion of patients whose cancer completely disappeared. The objective response rate (ORR), the proportion of patients whose tumors shrank by a certain level or more, was 75.3%.
In addition, it demonstrated an excellent safety profile, with an 8.9% incidence of grade 3 or higher severe cytokine release syndrome (CRS) and a 3.8% incidence of severe neurotoxicity (NE), which had been cited as major limitations of CAR-T therapy, thereby securing both the efficacy and safety required of next-generation CAR-T treatments.
Curocell has also built Korea's largest CAR-T-dedicated good manufacturing practice (GMP) facility in Daejeon to carry out all processes in-house. Unlike overseas manufacturing and transport models, it dramatically shortened the manufacturing and supply turnaround time (TAT) from patient blood collection to therapy receipt and secured a stable supply chain.
Accordingly, Curocell believes rapid market entry and steep revenue growth will be possible immediately upon reimbursement listing. The company plans to expand treatment centers to 30 medical institutions nationwide within the year to establish a system that enables prescriptions anywhere in Korea.
Curocell CEO Kim Geon-su said, "The passage at the sixth Cancer Drug Review Committee is a meaningful result that once again recognizes, from experts, Limcato's excellent efficacy and safety, as well as the need for a new drug," adding, "With the commercialization process proceeding as planned from marketing authorization to the establishment of reimbursement criteria, we will swiftly conclude the remaining follow-up procedures, including the Drug Reimbursement Review Committee and price negotiations, to provide health insurance benefits to patients in the second half of this year and at the same time drive Curocell's full-fledged revenue growth."