Curocell Submits Korean Approval Application for ‘Rimcarto’

Curocell announced on the 30th that it has submitted a marketing authorization application to the Ministry of Food and Drug Safety (MFDS) for its next-generation CAR-T therapy, 'Rimcarto (Anbal-cel)'.

CAR-T therapy involves extracting a patient’s immune cells, engineering them to attack cancer cells, and reinfusing them into the patient. With the potential to cure advanced blood cancers with a single dose, CAR-T is often referred to as a "miracle therapy." Curocell is the first Korean company to develop a CAR-T therapy and initiate the regulatory approval process.

Rimcarto is being evaluated for approval as a treatment for large B-cell lymphoma (LBCL) in patients who have relapsed or are refractory to existing treatments. In Phase 2 clinical trials, Rimcarto demonstrated an impressive complete response rate of 67.1% (complete tumor disappearance) alongside robust safety data. Curocell anticipates that Rimcarto will offer a new therapeutic option for patients with advanced blood cancers.

Notably, on the 10th of this month, Curocell was selected for the Ministry of Health and Welfare’s pilot program for parallel approval, reimbursement evaluation, and pricing negotiations. This initiative is designed to streamline the process, enabling faster market access by finalizing pricing negotiations alongside regulatory approval. According to Curocell, this program makes a 2024 launch highly likely for Rimcarto.

Kim Gunsoo, CEO of Curocell, stated, “If Rimcarto secures domestic approval, it will provide LBCL patients with enhanced treatment opportunities. We are committed to delivering this breakthrough therapy to those in need.”