Korea's CAR-T cell (chimeric antigen receptor T cell) therapy market is approaching an inflection point. "Limcato (development name Anbalsel)," Curocell's core pipeline and the country's first CAR-T cell therapy in the spotlight, is awaiting a Ministery of Food and Drug Safety approval decision in the first quarter of this year.
Over the past three months, Curocell's share price has remained strong on expectations for Limcato's approval. Starting in the high 30,000 won range from late Oct. to Nov. last year, the stock rose to the high 40,000 won range in early Dec., and closed at 55,200 won on the 9th.
If approval is granted, a fast-track process will apply through listing for national health insurance reimbursement and price negotiations, leading to a potential launch as early as the second quarter and revenue starting in the second half, according to projections. However, since the approval timing has already been delayed once, the market's gaze is fixed both on expectations and on remaining variables.
◇first domestic CAR-T, challenge to Kymriah·Yescarta
Limcato is a CAR-T cell therapy indicated for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Diffuse large B-cell lymphoma is considered one of the blood cancers in which treatment outcomes have improved relatively clearly. More than half of patients reach long-term survival with standard chemotherapy alone.
But outcomes diverge after first-line therapy. Those who do not respond to treatment or relapse without achieving complete remission are categorized as "relapsed or refractory." At this stage, the limits of existing treatment options become evident, and CAR-T cell therapies have emerged as an alternative.
Curocell submitted a marketing authorization application for Limcato to the Ministery of Food and Drug Safety on Dec. 30, 2024. In the same month, it was also selected in the second round of the Ministry of Health and Welfare's "pilot project linking new drug approval, reimbursement, and pricing." Accordingly, the marketing authorization review, national health insurance reimbursement assessment, and price negotiations are proceeding simultaneously.
If Limcato is approved, a competitive landscape is already in place. Novartis' "Kymriah" is currently on the domestic market, and Gilead's "Yescarta" has been approved as a second-line therapy and is undergoing reimbursement review.
Curocell emphasizes two main competitive edges. First is a domestic, self-contained manufacturing system. Global CAR-T cell therapies collect a patient's blood, ship it overseas for cell manufacturing, and then bring it back to Korea. Limcato, by contrast, can be produced domestically, which is seen as an advantage in supply speed and logistics stability.
Second are the clinical results. According to the company's final phase 2 data, among 79 participants, the complete remission (CR) rate—where all cancer cells disappeared after Limcato administration—was 67.1%. The objective response rate (ORR), which indicates the proportion of patients whose tumors shrank by a certain threshold after anticancer treatment, was 75.3%. Both figures are higher than Kymriah's (39.1%, 53%).
Long-term follow-up results also draw attention. The 12-month progression-free survival (PFS) was 41.1%, and the 18-month PFS was 35.2%. Overall survival (OS) was 66.6% and 57.3%, respectively. Notably, the median progression-free survival (mPFS) was 6 months, far exceeding the 2.9 months reported in Kymriah's trial.
However, in prescribing experience and global references, it is in a position to compete with existing products.
◇diversifying the pipeline by expanding indications… solid tumor therapies, too
The number of domestic patients with relapsed or refractory DLBCL is estimated at a minimum of 300 to a maximum of 600 per year. Considering the per-person price of a CAR-T cell therapy, the domestic market is estimated at 90 billion to 180 billion won annually.
Limcato is currently under development and review as a third-line therapy, but in the mid to long term, the plan is to move the indication up to a second-line therapy, where the market is larger. The target for Limcato's entry into a second-line clinical trial is in the second half of this year.
Indications are also being broadened. Adult acute lymphoblastic leukemia (ALL) received phase 2 IND approval in Oct. last year, and last month, severe systemic lupus erythematosus (SLE) received approval for an IND amendment for phase 1/2. The amendment clarified the efficacy endpoints for phase 2.
Curocell is also taking on the development of solid tumor CAR-T Therapy based on the "HyperCytokine" platform secured through an exclusive license with Seoul National University. The technology loads immunomodulatory agents onto CAR-T cells to simultaneously enhance in vivo activity and persistence. The plan is to obtain human efficacy data through investigator-initiated trials in countries such as China and India and then pursue global partnerships.
◇if approval is delayed again… warning lights for both stock price and revenue
Curocell raised 32 billion won through an initial public offering (IPO) at the end of 2023 and secured an additional total of 3 billion won in external funds last year. Following a decision early last year to issue 33 billion won in convertible bonds (CB), the company disclosed an additional 10 billion won CB issuance in Sept. last year. The company says it has sufficient operating funds through Limcato's commercialization.
But the approval timing remains a variable. Limcato initially targeted approval by the end of last year but was pushed back. In general, under Ministery of Food and Drug Safety rules, a decision on approval for advanced biopharmaceuticals is made within 120 business days, and Curocell is subject to a 90-day review on a fast-track.
Limcato's strategy assumes bringing forward the launch timing by conducting approval, reimbursement assessment, and price negotiations in parallel. If the approval timing is delayed, the launch schedule will inevitably be pushed back, and the timing of revenue generation will naturally be delayed as well.
In that case, pressure could increase on Curocell's cash burn rate. Curocell is currently pre-commercial with no revenue, and its cumulative operating loss through the third quarter of last year reached 27.6 billion won. If approval is delayed further, ongoing clinical, manufacturing, and personnel expense could continue to accrue, lengthening the cash outflow period.
In particular, all CBs raised last year become convertible in stages starting this year. If approval and commercialization are delayed, it could affect future financing strategies in tandem with stock price trends.
The company says that, along with the symbolism of being Korea's first CAR-T cell therapy, multiple supplements have been made during the review of the complex manufacturing process (CMC) and the BLA review of the GMP-based plant and operating system, lengthening the review period.
Curocell CEO Kim Geon-su said, "Limcato has the advantage of significantly shortening the time from approval to national health insurance reimbursement listing compared with the existing process," adding, "We expect this to enable a more flexible launch."
Industry sources also said, "Given the number of supplements and the limits on supplement timelines, most of the review period has effectively been consumed," and the mood points to the possibility of a decision in the first quarter. There is also an assessment that it is hard to say Limcato's pace is excessively slow, considering that global CAR-T cell therapies took 7 months for Kymriah, 8 months for Yescarta, and 1 year and 2 months for Carvykti to win domestic approval.
Curocell's current market capitalization is about 730 billion won. Much of Limcato's launch potential appears priced in, and after approval, actual revenue visibility is expected to matter more than expectations.
Ha Tae-gi, an analyst at Sangsangin Investment & Securities, said, "The stock price is likely to maintain a positive trend until product approval, and after that the stock will react with a focus on the scale of revenue."