A final decision on the approval of RIMQARTO (anbalcabtagene autoleucel), a chimeric antigen receptor T-cell (CAR-T) therapy developed by Curocell, is expected on April 2. This comes approximately 16 months after the company completed its application. If the review results favor approval, it will mark the launch of South Korea’s first homegrown CAR-T therapy.
According to pharmaceutical and biotech industry sources on the 31st, the Ministry of Food and Drug Safety (MFDS) will convene the Central Pharmaceutical Affairs Deliberation Committee on April 2 to evaluate the gene therapy application. As the statutory advisory body for the MFDS, the committee serves as the final checkpoint for assessing the efficacy and safety of new drugs. The primary agenda for this session is RIMQARTO, a CAR-T therapy targeting hematologic malignancies.
RIMQARTO is a CAR-T candidate designed to target the CD19 receptor found on the surface of certain blood cancer cells. It belongs to the same class as globally recognized therapies, including Novartis’s Kymriah, Gilead Sciences’s Yescarta and Tecartus, and Bristol Myers Squibb’s (BMS) Breyanzi. Currently, Kymriah and Yescarta are the primary options available in the Korean market. CAR-T therapy is a highly personalized treatment where a patient’s own T cells are collected, genetically modified to attack only cancer cells, and re-infused.
In a domestic Phase 1/2 trial for third-line treatment of patients with large B-cell lymphoma (LBCL), Curocell reported an objective response rate (ORR) of 75.3% and a complete remission (CR) rate of 67.1%. Based on these results, the company filed for approval in December 2024.
Delays in the Parallel Pilot Program
Around the same time, the Ministry of Health and Welfare selected RIMQARTO as the second drug for the "Parallel Pilot Program," an initiative designed to fast-track patient access by running the approval application, reimbursement evaluation, and drug price negotiations simultaneously.
Under standard procedures, a new drug launch can take over 300 days due to sequential steps: 120 days for MFDS approval, 150 days for reimbursement review by the Health Insurance Review and Assessment Service (HIRA), and 60 days for price negotiations. While RIMQARTO was initially expected to enter the market in 2025, the timeline was repeatedly pushed back due to political factors, including administrative shifts and personnel changes among officials responsible for the program.
Despite these delays, investor confidence has remained strong. Curocell’s stock price rose steadily from the 30,000-won range last July to approximately 54,000–56,000 won recently, driven by expectations of a positive regulatory outcome.
Faster Production and Superior Efficacy
Curocell estimates the domestic market for large B-cell lymphoma treatments at approximately 100 billion won. The company aims to establish RIMQARTO as a market leader before expanding into broader East Asian markets.
The drug’s competitive edge lies in two key areas: processing time and efficacy. While multinational products like Kymriah typically require about 40 days for preparation and delivery, RIMQARTO is known to be ready for administration in just 14 days. Furthermore, its reported CR rate of 67% is significantly higher than the 40% to 50% seen in competing multinational therapies.
"Once the Drug Review Committee reaches a conclusion, an official announcement is typically made within a few weeks if the process moves quickly," said an industry source specializing in cell-based therapies. "If RIMQARTO launches this year, Curocell will not only validate its technological capability as the creator of Korea's first CAR-T but also gain significant momentum for its follow-on pipeline."
