Domestic CAR-T Therapy 'Rymcto-ju' Approved as 42nd New Drug

The Hankyoreh celebrates a landmark achievement in South Korea's pharmaceutical innovation with the approval of 'Rymcto-ju,' the nation's first domestically developed CAR-T cell therapy. This breakthrough, designated as the 42nd new domestic drug, signifies a major leap forward in the country's quest for self-sufficiency in advanced medical treatments.

The newly approved therapy, targeting relapsed or refractory diffuse large B-cell lymphoma and primary mediastinal B-cell lymphoma, offers a vital new treatment option for adult patients who have exhausted other systemic therapies. CAR-T therapy, a sophisticated form of immunotherapy, involves genetically modifying a patient's own immune cells to target and destroy cancer cells. Until now, such advanced treatments have been largely dominated by expensive foreign products, placing a significant burden on patients and the healthcare system.

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The approval of Rymcto-ju has become a great milestone in the history of new drug development in our country. I am grateful to the many people who have worked hard until now.

This domestic development was not achieved in isolation. Government agencies, including the Ministry of Health and Welfare and the Ministry of Food and Drug Safety, along with the National New Drug Development Project Group, provided comprehensive support throughout the research and development process. This collaborative effort, from initial development to commercialization and expedited review, underscores a national commitment to fostering homegrown biopharmaceutical capabilities. The inclusion of 'Rymcto-ju' in the Ministry of Health and Welfare's pilot program for parallel review, evaluation, and negotiation is also expected to expedite its inclusion in the national health insurance coverage.

Looking ahead, the developer, Curocell, aims to expand the therapy's applications to other blood cancers, autoimmune diseases, and even solid tumors, with a particular focus on developing CAR-T treatments for challenging cancers like liver, stomach, and pancreatic cancer. While the development of CAR-T therapies for solid tumors presents significant challenges, a successful breakthrough would unlock immense market potential and clinical impact, given the current limitations of CAR-T treatments primarily to blood cancers. This achievement is not just a scientific triumph but a testament to South Korea's growing prowess in cutting-edge biotechnology, promising greater accessibility and affordability for patients in the future.

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We have received the first new drug approval in Korea, where we started research in the wasteland of CAR-T technology. Based on the capabilities and experience we have accumulated, we will do our best for the global success of domestic CAR-T technology in the future.