On Dec. 10, Curocell’s locally developed CAR-T therapy, “Rimqarto,” was selected by the Ministry of Health and Welfare as the second drug for expedited approval and market launch through the “Simultaneous Approval-Insurance Evaluation-Drug Price Negotiation” process.
This significant milestone marks a pivotal moment for Curocell, a South Korean biotechnology company, as it moves closer to the approval of Rimqarto (ingredient name: Anbal-cel), the first domestic CAR-T cell therapy. CEO Kim Geon-soo announced on dec. 23 at the company’s headquarters in Daejeon that the approval is imminent, signaling a breakthrough in the treatment of relapsed or refractory large B-cell lymphoma.
CAR-T cell therapy, an advanced form of immunotherapy, involves genetically modifying a patient’s T cells to target and kill cancer cells. Historically, this technology has been the exclusive domain of the United States and Europe. Kim highlighted the significance of this development, stating, “Chimeric antigen receptor T-cell (CAR-T) therapy is one of the advanced technologies. It has long been the exclusive domain of the United States and Europe, and only a few countries have succeeded in developing it. It is significant that Korea has joined the ranks of countries that have developed it independently.”
The journey to this point has been rapid and impressive. Curocell’s progress towards commercializing an anticancer therapy has taken less than two years since its technical special listing. Kim explained the logistical advancements that have facilitated this progress: “CAR-T cell therapy used to take an average of 40 days as it involved sending the frozen processed cells to the U.S. from hospitals equipped with special facilities. Curocell has already completed a Good Manufacturing Practice (GMP) facility in Daejeon for Rimqarto production, making it possible to administer the treatment within two weeks.”
The clinical results for Rimqarto are promising, with a complete remission rate of 67.1%. Curocell is also conducting clinical trials for adult leukemia and plans to expand indications to systemic lupus erythematosus. The Ministry of Health and Welfare’s pilot project aims to achieve approval and insurance coverage simultaneously within six months, which could significantly expedite patient access to this innovative treatment.
Curocell’s journey has been supported by key collaborations with prominent academic and medical institutions. Kim noted, “When the company was founded in 2016, there was no domestic expertise, clinical institutions, or regulatory authorities with experience in CAR-T. However, with the joining of Prof. Kim Chan-hyuk from Seoul National University and Prof. Shim Hyun-bo from Ewha Womans University, and despite the burden of being the first to administer CAR-T in Korea, Samsung Medical Center and Director Kim Won-seok of the CAR-T Cell Therapy Center quickly completed the Phase 1 trial.”
Looking ahead, Curocell is preparing for global business expansion. Kim revealed, “There are countries in South America, the Middle East, and Southeast Asia with many patients and financial resources but lacking technology. We are discussing a turnkey export method that includes both production facilities and technology.” This strategy could position Curocell as a key player in the global market for advanced cancer treatments.
Curocell’s next pipeline is expected to be a treatment for T-cell lymphoma, a project with significant global value due to the lack of existing treatments. Kim shared, “Since there is no treatment for T-cell lymphoma yet, it is a highly valuable project globally. We have obtained better data through animal experiments than recently approved immunotherapy for solid tumors and expect results soon.” To secure the necessary funds for this new pipeline, Curocell recently established a U.S. subsidiary.
On the first floor of Curocell’s headquarters, a phrase reads, “Remember that you have helped 98 patients.” This serves as a constant reminder of the company’s mission and impact. Kim emphasized, “The number goes up by one each time the number of treated patients increases. We will continue to strive to develop innovative treatments to protect the lives and health of patients.”
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