Curocell's Rimqarto Becomes Korea's First Approved CAR-T Therapy

Curocell’s headquarters and GMP manufacturing facility in Daejeon. Photo by Curocell.

Curocell’s “Rimqarto” has become the first domestically approved product in Korea’s personalized gene therapy market, which had previously been dominated by imported treatments.

The Ministry of Food and Drug Safety (MFDS), led by Commissioner Yu-kyung Oh, announced on April 29 that it has approved the CAR-T therapy Rimqarto injection (anbalcabtagene autoleucel), developed in Korea.

CAR-T therapies are personalized gene treatments that involve genetically modifying a patient’s immune cells to recognize and attack cancer cells.

According to the MFDS, Rimqarto is designated as an orphan drug for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma who have received at least two prior systemic therapies.

The therapy works by engineering a patient’s T cells to target CD19, a surface antigen on B cells, before reinfusing them into the body. These modified cells then identify and destroy CD19-expressing cancer cells. Rimqarto also inhibits PD-1 and TIGIT, immune checkpoint receptors that suppress T-cell activity, helping enhance immune response and prevent tumor evasion.

The MFDS supported the therapy’s development through its Advanced Biopharmaceutical Product Development Support Program (“Bio Challenger”) and designated it as the 33rd product under the Global Innovative Product Fast Track (GIFT) program, offering tailored consultations and expedited review.

The agency noted that approval of a domestically developed CAR-T therapy reduces reliance on costly imports and enables local production, improving treatment accessibility for patients with limited options.

The MFDS added it will continue to apply its regulatory science expertise to accelerate access to safe and effective therapies for rare and life-threatening diseases.