The Korean regulator approved Curocell’s Rimqarto (anbalcabtagene autoleucel), the first Korean-developed CAR-T therapy, intensifying competition in Korea’s relapsed or refractory large B-cell lymphoma treatment market.
On Wednesday, the Ministry of Food and Drug Safety said it approved Rimqarto, a CAR-T therapy developed by Curocell. This marks the first time a CAR-T therapy developed by a Korean company has received MFDS approval.
Curocell's office and GMP plant in Daejeon. (Courtesy of Curocell)
Rimqarto was approved for adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have relapsed or failed to respond after two or more lines of systemic therapy.
With this approval, Korea’s CAR-T market is being reshaped into a competitive landscape that now includes Novartis’ Kymriah (tisagenlecleucel), Gilead Sciences’ Yescarta (axicabtagene ciloleucel), and Rimqarto.
Yescarta, in particular, has been approved in Korea both as a second-line treatment for DLBCL patients who relapse or are refractory within 12 months after first-line chemoimmunotherapy, and as a treatment for relapsed or refractory DLBCL and PMBCL after two or more lines of systemic therapy. Based on labeled indications alone, Yescarta is positioned earlier in the treatment sequence than Rimqarto.
However, in real-world clinical practice in Korea, reimbursement -- not approval -- often determines whether a drug is prescribed. Yescarta currently has reimbursement criteria set for third-line or later DLBCL and PMBCL, but not for second-line DLBCL.
As a result, industry observers say that despite Yescarta’s advantage of a second-line indication, patient access in Korea will remain limited unless reimbursement is secured.
CAR-T therapies are single-administration treatments with high costs, requiring extensive hospital infrastructure from leukapheresis and manufacturing to lymphodepleting chemotherapy and post-infusion adverse event management. In second-line settings, reimbursement negotiations are expected to be particularly challenging, as they must demonstrate long-term survival benefits over existing treatments while also accounting for the impact on national health insurance finances.
For Curocell, this represents a key opportunity for market entry. Rimqarto has been approved as a third-line or later treatment for DLBCL and PMBCL and was already designated for a pilot program that allows parallel review of approval, reimbursement evaluation, and pricing negotiations. If reimbursement proceeds quickly after approval, its status as a domestically manufactured CAR-T therapy could become a key differentiator in patient access and hospital operations.
Another strength of Rimqarto is its clinical data. According to disclosed trial results from the CRC01-01 study in large B-cell lymphoma patients, Rimqarto demonstrated an objective response rate (ORR) of 75.3 percent and a complete response (CR) rate of 67.1 percent. Median progression-free survival (PFS) was 5.5 months, and median duration of response (DoR) was 15.6 months.
In terms of safety, Rimqarto showed relatively manageable profiles for key CAR-T toxicities -- cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). In its pivotal trial, CRS occurred in 56 percent of patients, with grade 3 or higher CRS in 10 percent. ICANS occurred in 11 percent, with grade 3 or higher events in 2 percent.
Yescarta is also an established global standard in DLBCL, but management of CRS and neurotoxicity remains a key consideration in clinical practice. Published data show CRS rates of 90 percent, including grade 3 or higher CRS in 9 percent, in non-Hodgkin lymphoma, and 93 percent, including grade 3 or higher CRS in 9 percent, in large B-cell lymphoma. Real-world analyses reported CRS in 87 percent, including grade 3 or higher CRS in 5 percent, and ICANS in 50 percent, including grade 3 or higher ICANS in 22 percent.
However, Rimqarto and Yescarta have not been compared in head-to-head trials. Differences in patient populations, study design, assessment timing, and toxicity management make it difficult to draw conclusions on relative efficacy or safety based on simple numerical comparisons.
Even so, in real-world practice, CAR-T selection considers not only efficacy but also toxicity management, length of hospitalization, ICU capacity, and the hospital’s cell therapy infrastructure.
Clinicians note that although there are no direct comparative data, the burden of managing Yescarta’s toxicities may be a differentiating factor in practice.
A hematologic oncologist at a major Korean university hospital said, “There are no head-to-head data, so it is difficult to directly compare Yescarta and Rimqarto. However, Yescarta has long been associated with a relatively higher burden of CRS and neurotoxicity management in both global trials and real-world use. In contrast, Rimqarto showed relatively lower rates of severe CRS and ICANS in domestic trials, which could be an important differentiating factor in clinical practice.”
The physician added, “For CAR-T therapies, early toxicity management after infusion is just as important as response rates. In Korea, decisions will likely depend on ICU access, physician experience, and patient condition.”
Global market trends also provide context for Yescarta’s entry into Korea. According to Gilead, Yescarta generated $1.5 billion in global sales last year, down 5 percent year-on-year, with increased competition cited as a key factor.
By contrast, BMS’s CD19 CAR-T therapy Breyanzi (lisocabtagene maraleucel) posted $1.358 billion in sales, up 82 percent year-on-year. In the fourth quarter of 2025 alone, Breyanzi sales reached $392 million, surpassing Yescarta’s $368 million.
This suggests that while Yescarta remains a leading product globally, the competitive landscape is already shifting. Breyanzi has gained traction in the U.S. with a more favorable safety profile, while Yescarta has competed on strong efficacy and long-term data. Some industry observers say Gilead Sciences’ later push into Asian markets, including Korea, should be viewed in the context of slowing U.S. sales.
In Korea, however, reimbursement and manufacturing logistics are likely to matter more than global positioning. Yescarta is an imported CAR-T therapy that requires patients’ cells to be sent to overseas manufacturing facilities and then shipped back to Korea.
Rimqarto, by contrast, can be manufactured and supplied domestically, giving it potential advantages in production time, logistics, hospital coordination, and supply stability.
Curocell has already begun commercialization preparations, securing marketing personnel and engaging in discussions with major hospitals for the supply of commercial products even before approval. Beyond the symbolism of being a domestically developed CAR-T, how quickly it can deliver the therapy to patients and secure reimbursement is likely to determine early market share.
Ultimately, the key variable will be the speed of reimbursement. Whether Yescarta can translate its second-line approval into reimbursement, and whether Rimqarto can quickly establish itself in the third-line setting based on domestic manufacturing and parallel approval-reimbursement procedures, will likely shape the competitive landscape of Korea’s CAR-T market.
Given the limited treatment options for patients with relapsed or refractory DLBCL, future competition is likely to extend beyond simple product superiority to how quickly patients can gain real access to available CAR-T treatment options.
Hong Sook
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