[비즈한국] Could 2026, the Year of the Red Horse (Byeong-o Year), become the first year of a 'K-cell therapy' renaissance? Eyes are turning toward domestic cell therapies nearing market launch. With the domestic cell therapy market (estimated at 120 billion KRW) accounting for only about 1.5% of the global market (estimated at 8.3051 trillion KRW), there is growing anticipation that new entries will quickly narrow the global gap.
According to industry sources on the 24th, Curocell's third-line treatment for relapsed or refractory large B-cell lymphoma (LBCL), 'Anbal-cel', is expected to be approved as the first domestic CAR-T (chimeric antigen receptor T-cell) therapy next year. There are also expectations that it will be launched in the market soon after approval. This is because the marketing authorization application was submitted to the Ministry of Food and Drug Safety (MFDS) in December 2024, and it was selected as the second candidate for the Ministry of Health and Welfare's 'pilot project for simultaneous approval, reimbursement assessment, and drug price negotiation,' meaning approval and reimbursement assessment are proceeding concurrently.
CAR-T therapy works by extracting T-cells from a cancer patient's blood, genetically modifying them to recognize and attack only cancer cells, equipping them with a CAR, culturing them in large quantities, and then re-infusing them into the patient's body to kill the tumors. As a personalized treatment, it can offer near-curative effects for terminal blood cancer patients with just a single administration.
Curocell's Anbal-cel: Comparable efficacy to competitors Kymriah and Yescarta, with fewer side effects
Anbal-cel is attracting industry attention by demonstrating equal or better therapeutic efficacy and significantly lower side effects compared to Novartis' 'Kymriah' and Gilead's 'Yescarta', both of which have already been approved by the MFDS and the U.S. Food and Drug Administration (FDA). According to European Hematology Association (EHA) presentation materials and Curocell, the objective response rate (ORR) of Anbal-cel is 75%. While lower than Yescarta's 83%, it is higher than Kymriah's 52%. Regarding complete remission rate (CR), Anbal-cel leads with 67%, surpassing Kymriah at 40% and Yescarta at 54%.
In safety metrics, it showed superior competitiveness. The incidence of grade 3 or higher severe cytokine release syndrome, a primary side effect of CAR-T therapy, is 9% for Anbal-cel, whereas it is over twice as high at 22% for Kymriah, and 11% for Yescarta. The severity of brain and nervous system abnormalities was also limited to 4% in the Anbal-cel group, compared to 12% for Kymriah and 33% for Yescarta.
Prospects suggest Anbal-cel will also hold an edge in price competitiveness. Kymriah is an ultra-high-priced drug costing $475,000 (700 million KRW) in the U.S., while Yescarta costs $420,000–$430,000 (600 million KRW). Yescarta was approved by the MFDS this past August but has not yet been launched in Korea. In contrast, the domestic reimbursement cap for Kymriah, which was approved by the MFDS in March 2021 and is currently sold in Korea, is 360 million KRW. Industry and securities experts expect the price of the latecomer Anbal-cel to be set between 320 million and 360 million KRW, not exceeding Kymriah.
Curocell plans to expand the indications for Anbal-cel to secure a competitive edge over Kymriah and Yescarta. They are focusing on: △Second-line treatment for LBCL, △Relapsed or refractory adult acute lymphoblastic leukemia, and △Lupus nephritis, an autoimmune disease. In particular, the development of a treatment for lupus nephritis is expected to serve as an opportunity to expand the scope of CAR-T therapy, which has until now been used only for blood cancer treatment.
ViroMed: Two-track strategy of conditional new drug approval and regenerative medicine therapeutic plans
ViroMed is also cited as one of the companies expected to commercialize cell therapy next year. On the 2nd, the company announced the top-line results of its Phase 2 clinical trial for 'VT-EBV-N', a treatment for the rare and intractable blood cancer NK/T cell lymphoma, and stated its plan to apply for conditional marketing authorization from the MFDS next year. Ki Young-wook, Managing Director of Innovation Strategy Management at ViroMed, said at a press conference, "Our goal is to receive the results report early next year, apply for fast-track designation from the MFDS in the first half of the year, and apply for conditional approval in the second half," adding, "We expect to reach commercialization through our domestic partner Boryung003850 in the first half of 2027.”
Beyond diversifying the indications for VT-EBV-N to include progressive multiple sclerosis, nasopharyngeal carcinoma, and Epstein-Barr virus (EBV)-positive diffuse LBCL, ViroMed intends to target the global market by pursuing technology exports or overseas licensing agreements. Director Ki stated, "We will pursue technology exports to the Chinese market, where a 1 trillion KRW market for NK/T cell lymphoma treatments has formed.”
In addition to new drug approval, ViroMed is also raising expectations for the commercialization of VT-EBV-N under the Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals (Advanced Regenerative Medicine Act). While it may take until the first half of 2027 to launch as a new drug, following the Advanced Regenerative Medicine Act track could allow for much faster market entry. It is known that five companies, including ViroMed, have been named as subjects for regulatory sandbox deliberation, which grants special exceptions to apply for advanced regenerative medicine treatment plans based on commercial clinical trial results from April to October of this year. Ki Pyung-seok, CEO of ViroMed, said, "Once the regulatory sandbox is approved next January, it can be used in the field immediately.”