Curocell (KOSDAQ: 372320) said that RIMQARTO® Inj. (anbalcabtagene autoleucel), South Korea’s first domestically developed CAR T-cell therapy, has secured full regulatory approval from the Ministry of Food and Drug Safety (MFDS) on April 29. With this approval, RIMQARTO® becomes the 42nd drug domestically developed under the Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products for manufacture and sale. This represents the first commercialization of CAR T-cell therapy by a Korean company.
The CAR T-cell therapy is a personalized autologous T-cell immunotherapy in which a patient’s immune cells are genetically modified to selectively target cancer cells. RIMQARTO® has drawn attention as a next-generation CD19 CAR T-cell therapy powered by Curocell’s proprietary OVIS™ (Overcome Immune Suppression) technology. This technology is designed to regulate immunosuppressive signals in the tumor microenvironment, addressing “T-cell exhaustion,” and enabling more sustained anticancer activity over the long term.
RIMQARTO® is indicated for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) in adults following two or more lines of systemic therapy.
In the pivotal Phase 2 trial supporting the approval, RIMQARTO® achieved an objective response rate (ORR) of 75.3% and a complete response (CR) rate of 67.1%. The therapy also showed its safety profile, with cytokine release syndrome (CRS), a key adverse event associated with CAR T-cell therapy, reported in 10% of patients, and immune effector cell-associated neurotoxicity syndrome (ICANS) reported in 5%.
Although RIMQARTO® was initially submitted for conditional approval, the MFDS waived the requirement for Phase 3 trial data during the review process, taking into account its use as a third-line treatment for lymphoma and its classification as a novel CAR T-cell therapy. As with other global CAR T-cell therapies, the approval is subject to long-term follow-up studies and risk management plans to monitor the therapy’s safety and efficacy.
The approval reflects the combined impact of the MFDS’s expedited review framework and full-cycle support from government R&D programs. RIMQARTO® was developed with support from the Ministry of Health and Welfare (MOHW) R&D program and the Korea Drug Development Fund. In addition, the MFDS’s “Bio-Challenger Program” for advanced biopharmaceuticals and RIMQARTO®’s “Global Innovative Products on Fast Track” (GIFT) and fast-track processing designations enhanced both efficiency and speed throughout the development and approval review processes.
RIMQARTO® was also selected for the MOHW’s “Concurrent Pilot Program for Approval-Evaluation-Negotiation,” which is expected to shorten the timeline from its approval to national health insurance reimbursement listing.
Curocell CEO Kim Gun-soo said, “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. We have been researching because CAR T-cell technology was not available in Korea. We have now secured our first new drug approval. With the capabilities and experience accumulated so far, we are committed to advancing the global success of Korea’s CAR-T technology.”
Building on RIMQARTO®, Curocell plans to pursue indication expansion, global market entry, and the development of next-generation pipelines, while further demonstrating the scalability of its CAR-T platform by expanding into solid tumors and autoimmune diseases.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260429207749/en/
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