[Edaily Reporter Na Eun-kyung] #Curocell, the first Korean company to successfully commercialize the chimeric antigen receptor T-cell (CAR-T) therapy Limkato, is now setting its sights on the Japanese market as its next strategic target. This is because while the domestic market for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) is limited, Japan offers a larger patient population and an already established CAR-T treatment infrastructure. In particular, Curocell, which has established a rapid supply system based on its Daejeon production facility, is set to use Japan as a springboard to target the Asian market.

Japan to be the first overseas base following domestic establishment

According to Curocell on the 5th, the company is currently focusing its efforts on securing domestic reimbursement coverage for Limkato. Curocell plans to begin the formal reimbursement process for Limkato following a re-review by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee this coming July.

In addition, Curocell is already making parallel preparations for its entry into the Japanese market. The company plans to pursue formal approval procedures, including local clinical trials, to enter the Japanese market. Curocell is also reviewing various business models, such as forming partnerships with Japanese pharmaceutical companies or technology transfers.

In particular, Curocell plans to simultaneously launch Phase 3 clinical trials in Korea and Japan next year to expand Limkato’s indication from its current status as a third-line treatment to a second-line treatment.

A Curocell official stated, “While we are currently focused on establishing a foothold in the domestic market, we are also laying the groundwork for our entry into Japan,” adding, “We plan to conduct Phase 3 clinical trials simultaneously in Korea and Japan next year to expand the indication for Limkato to second-line lymphoma treatment.”

“Made in Korea, Supplied to Japan”…Highlighting Geographical Strengths

Curocell’s choice of Japan as its first overseas market is not solely due to market size. CAR-T therapy refers to a highly personalized treatment in which a patient’s immune cells are collected, sent to a manufacturing facility, genetically modified and cultured, and then re-administered to the patient. CAR-T requires a strict cold chain system during cell transport, and logistics distance directly impacts the treatment schedule.

Multinational pharmaceutical companies currently leading the global CAR-T market operate a system where they send cells from Asian patients to production facilities in the U.S. or Europe for manufacturing, and then supply the finished product back to each country. For example, Novartis’s Kymriah is known to typically take about 4 to 8 weeks from manufacturing to delivery.

In contrast, Curocell has established CAR-T production infrastructure at its GMP-certified facility in Daejeon. By manufacturing and supplying the product from South Korea, which is geographically close to Japan, the company can significantly reduce logistics costs and delivery times.

A Curocell official explained, “Global Big Pharma companies incur significant time and costs by sending cells from Asian patients to factories in the U.S. or Europe for manufacturing and then shipping them back.” They added, “In contrast, Curocell possesses a fully developed CAR-T manufacturing infrastructure domestically, so if we target Japan as our first foothold, we can efficiently penetrate the Asian market in terms of both cost and time.”

Breaking into the Demanding Japanese Market Will Boost Global Credibility

Japan is considered one of the most advanced countries in the fields of cell therapy and regenerative medicine. It has high regulatory standards and strict quality criteria. However, successfully entering this market is interpreted as recognition of a product’s competitiveness.

Curocell views this as an opportunity. The company believes that if Limkato’s efficacy and safety data are validated in the Japanese market, it will have a positive impact on future global business expansion.

Limkato achieved a complete remission (CR) rate of 67.1% in Phase 2 clinical trials. Although direct comparisons are limited due to differences in clinical trial designs, based on the published figures, it is evaluated as being competitive compared to existing global CAR-T products.

A Curocell official emphasized, “If we can demonstrate Rimkato’s excellent efficacy and safety data in the demanding Japanese market, it will significantly boost our credibility in the global market.”

The fact that CAR-T treatment infrastructure is already established in Japan is also cited as an advantage. Japan is a market where global CAR-T therapies such as Kymriah, Yescarta, and Breyanzi are already in use. Curocell believes that since medical professionals and major hospitals have systems in place for CAR-T administration and patient management, market penetration can be accelerated if approval and pricing are successfully secured.

A Curocell official stated, “In Japan, medical professionals and hospital systems are already familiar with the operational framework for CAR-T therapies,” adding, “We believe that if product approval and drug pricing are successfully secured, the environment is in place for rapid penetration into clinical practice.”