A few years ago, the vice president of Türkiye personally proposed this project. I was living in the United Kingdom at the time, but I moved to Türkiye right away and started working.Muhammet Avcil, head of Biruni Cell Therapy
Türkiye has begun bringing in the manufacturing system for Korean bio venture chimeric antigen receptor T-cell (CAR-T) therapy as a national project. The plan is to transfer the entire package—manufacturing technology and quality control system, supply chain, and follow-up research and development—and build it into a domestic industry.
For this project, the vice president took the first step. The Turkish ambassador to Korea and the investment office also lent support. The partner chosen was Curocell(372320), which developed the blood cancer CAR-T Therapy "RIMQARTO."
Biruni Cell Therapy head Muhammet Avcil said in an interview with ChosunBiz on the 29th, We aim to replicate Curocell's manufacturing system in Türkiye as is, and use that as a springboard to jointly develop treatments for solid tumors and autoimmune diseases.
Avcil said, Türkiye is a medical tourism hub that attracts hundreds of thousands of foreign patients every year, and If CAR-T therapy is added, it could become a new treatment base for cancer patients from the Middle East and Europe.
Biruni Cell Therapy is the cell and gene therapy affiliate of Biruni, a private healthcare group in Türkiye. Avcil earned a Ph.D. in chemistry from Imperial College London and has led technology commercialization in drug delivery (DDS) for nearly 20 years.
Through cooperation with Curocell, Biruni recently completed a dedicated CAR-T manufacturing facility in Istanbul with 76 rooms. It is an advanced aseptic facility that individually controls each room's temperature, humidity, and airflow, and ranks among the largest single CAR-T manufacturing sites in the world.
A third-party audit is currently underway in accordance with European Medicines Agency (EMA) standards. Biruni plans to submit an application for approval to Turkish health authorities as soon as the results come out in about six weeks.
◇ After reviewing 162 candidates, Biruni joined hands with Curocell… "Approval experience was decisive"
The approach of bringing over the entire manufacturing system instead of importing a single CAR-T item reflects the Turkish government's view of linking advanced medical technology to national security. The Turkish government has designated the bio industry as the second strategic growth sector after defense and is offering Biruni incentives such as corporate tax relief, employment support, and equipment investment subsidies.
Behind the government's choice of Biruni is the research and development ecosystem the group has built. Biruni created a structure that connects research, clinical practice, and commercialization based on its own university, university hospital, and technopark. Modeled after Silicon Valley in the United States, the technopark currently houses more than 500 corporations and is equipped with an animal testing center and a clinical trial center.
On the strength of these capabilities, Biruni narrowed down its CAR-T partners. After comparing and analyzing 162 corporations in North America, Europe, and Asia, it ultimately selected Curocell.
Avcil said, After seeing Curocell's phase 2 results, I had a hunch the company would win approval for the first CAR-T Therapy in the country. RIMQARTO received item approval from the Ministery of Food and Drug Safety in Apr.
What scored higher than clinical outcomes was experience. Avcil said, Curocell had built a GMP (good manufacturing practice) facility and was a company that went through the approval process and actually secured approval. That experience mattered most.
◇ Annual capacity for 750 patients built… beyond Türkiye to the Middle East and Europe
Completing the manufacturing facility is only the beginning. Now comes the time for regulation.
The variable is the lack of precedent. Turkish health authorities have no experience approving cell and gene therapies.
Avcil also cited the approval process as key, noting, It may take time. But preparation is sufficient. He said, The crux will be proving quality equivalence between products manufactured in Korea and those produced in Türkiye, adding, We plan to take that process step by step.
To that end, Biruni employees previously trained for three months on the entire process at Curocell's headquarters. If RIMQARTO is approved in Türkiye, Curocell staff will also visit on site to verify that the process is implemented identically.
The goal is item approval next year. After that, the plan is to enter the Balkans, the Middle East, and European markets. Pricing talks with the Turkish government are underway to set it below currently marketed global CAR-T Therapy products.
Biruni says demand is being confirmed. He said, Eight patients from overseas sought treatment and came to Türkiye, and two of them are currently hospitalized at Biruni University Hospital, adding, Production capacity could become insufficient in the next 5 to 10 years. The Istanbul facility can produce treatments for up to 750 patients a year.
Avcil said, We expect both companies to generate sales starting the year approval is granted, but it is hard to pin down the market size now. Because the CAR-T market has not fully taken shape in either Türkiye or Korea, more accurate estimates will be possible once we see first-year results.
◇ Like Hyundai Motor… "Korean bio materials, parts, and equipment expected to expand overseas"
Biruni does not expect this project to end with cooperation with a single company, Curocell. It could become a springboard for Korean bio materials, parts, and equipment corporations to enter Türkiye, the Middle East, and Europe.
In fact, Biruni adopted the same equipment and consumables that Curocell procures domestically. Avcil said, One tube manufacturer had no experience with overseas deliveries, so we directly helped with the export procedures.
He said, If we can jointly make a complex therapy like CAR-T, we can certainly collaborate on other bio products, and In the future, Biruni will not be the only one looking for partners in Korea. Other Turkish corporations and neighboring countries are highly likely to follow the same model.
The Turkish government also plans to provide active support. Taha Saran, head of the Türkiye Investment Office in Korea, said, Just as Hyundai Motor and more than 20 Korean parts partners entered Türkiye together in the 1990s, cooperation with Curocell could be an opportunity for Korea's entire bio supply chain to move into new markets.
He said, In particular, the Middle East and European markets are where Türkiye has strong networks, adding, Korea and Türkiye are partners who can make up for each other's shortcomings.