South Korea Enters New Biotech Era with Approval of First Domestic CAR T-Cell Therapy

SEOUL, South Korea – April 30, 2026

In a landmark decision for South Korea’s burgeoning biopharmaceutical sector, the Ministry of Food and Drug Safety (MFDS) has granted full regulatory approval to RIMQARTO® Inj. (anbalcabtagene autoleucel), the nation's first domestically developed CAR T-cell therapy. Developed by Curocell (KOSDAQ: 372320), the approval marks a pivotal moment, positioning the country as a new player in the highly advanced field of cell and gene therapy and offering a critical new treatment option for cancer patients.

Approved on April 29, RIMQARTO® is indicated for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), two aggressive forms of blood cancer, after two or more previous lines of systemic treatment have failed. The therapy’s arrival is not just a scientific achievement but a strategic one, promising to enhance treatment accessibility and reduce the nation’s reliance on costly imported medicines.

A National Milestone Fueled by Government Support

The approval of RIMQARTO® is the culmination of a concerted national effort to foster innovation in advanced regenerative medicine. The therapy is the 42nd drug developed under the “Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products,” a legislative framework designed to accelerate the development of cutting-edge treatments.

Curocell’s journey was significantly expedited by a suite of government support programs. The therapy was part of the MFDS's “Bio-Challenger Program,” which provides customized consultations and rapid reviews. It also received a “Global Innovative Products on Fast Track” (GIFT) designation, a system that streamlines the path to commercialization for promising domestic therapies. This robust support structure, combined with funding from the Ministry of Health and Welfare (MOHW) and the Korea Drug Development Fund, created a fertile ground for this breakthrough.

Crucially, the MFDS waived the requirement for a large-scale Phase 3 trial, a decision that reflects both the therapy's designation as a third-line treatment for a serious condition and the compelling data from its pivotal Phase 2 study. This flexible regulatory approach is setting a precedent for how South Korea can fast-track vital new medicines to patients who need them most.

A New Lifeline for Lymphoma Patients

For patients who have exhausted conventional treatments like chemotherapy and radiation, CAR T-cell therapy represents a revolutionary approach. It involves extracting a patient's own T-cells, genetically engineering them in a lab to recognize and attack cancer cells, and then infusing them back into the patient's body as a living drug.

The clinical results for RIMQARTO® have been particularly impressive. In its pivotal Phase 2 trial, the therapy demonstrated a 67.1% complete response (CR) rate, meaning that more than two-thirds of patients saw a complete disappearance of their cancer. The overall objective response rate (ORR), which includes both complete and partial responses, was 75.3%.

These figures position RIMQARTO® favorably against established global competitors. For instance, in their respective key trials for similar indications, Novartis's Kymriah reported a CR rate of 40%, and Gilead's Yescarta reported a 54% CR rate. While direct head-to-head comparisons are complex due to differing trial populations, RIMQARTO®'s efficacy data is highly promising. Furthermore, its safety profile appears competitive, with key side effects like cytokine release syndrome (CRS) and neurotoxicity (ICANS) reported at lower rates than some first-generation CAR-T therapies.

The Science of Sustained Attack: OVIS™ Technology

What sets RIMQARTO® apart is Curocell's proprietary OVIS™ (Overcome Immune Suppression) technology. A major challenge in CAR T-cell therapy is “T-cell exhaustion,” a phenomenon where the engineered immune cells lose their effectiveness over time, especially within the hostile tumor microenvironment. Cancer cells often exploit immune checkpoints, such as PD-1 and TIGIT, to switch off the T-cell attack.

OVIS™ technology is designed to counteract this. It is a next-generation platform that engineers the CAR T-cells to not only target the CD19 protein on lymphoma cells but also to simultaneously suppress the expression of these inhibitory checkpoint receptors. By blocking these “off switches,” the OVIS™ technology allows the CAR T-cells to remain active and persistent for a longer period, enabling a more sustained and durable anti-cancer response. This technological advancement is a key factor behind the high complete response rates observed in clinical trials and represents a significant step forward in the evolution of CAR-T design.

Reshaping the Market with Domestic Production

Beyond its clinical and scientific merits, RIMQARTO®'s approval carries profound logistical and economic implications. Previously, South Korean patients requiring CAR-T therapy faced a lengthy and complex process involving shipping their cells overseas for manufacturing, a journey that could take up to two months and carried significant risk and cost.

Curocell has eliminated this bottleneck by establishing a state-of-the-art Good Manufacturing Practice (GMP) facility in Daejeon. This domestic production hub will slash the turnaround time—from T-cell collection to re-infusion—to approximately 14 days. This dramatic reduction not only provides a faster path to treatment for critically ill patients but also gives clinicians greater control and predictability. To manage this complex process, the company has also deployed CUROLINK, a cloud-based integrated system to track the entire personalized therapy supply chain.

The next critical step for Curocell is securing national health insurance reimbursement. The therapy is part of the MOHW's “Concurrent Pilot Program for Approval-Evaluation-Negotiation,” designed to shorten the timeline to reimbursement. Achieving favorable coverage will be essential for ensuring broad patient access and competing effectively with imported therapies.

In a statement, Curocell CEO Kim Gun-soo celebrated the achievement as a historic milestone. “The latest approval is a milestone in Korea’s new drug development history. We would like to express our gratitude to everyone who has worked tirelessly to make this achievement possible,” he said. “With the capabilities and experience accumulated so far, we are committed to advancing the global success of Korea’s CAR-T technology.”

Building on this foundational success, Curocell plans to expand RIMQARTO®'s indications, pursue global market entry, and apply its versatile CAR-T platform to new frontiers, including solid tumors and autoimmune diseases, heralding a new and ambitious chapter for the company and for South Korean biotechnology.