Judul : Nature Cell Launches First U.S. Stem Cell Therapy Hub in Baltimore
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Nature Cell Launches First U.S. Stem Cell Therapy Hub in Baltimore
Nature Cell, a biotechnology company from South Korea, officially revealed its intention to create the first stem cell therapy manufacturing center in the United States, located in Baltimore, Maryland. Ra Jeong-chan, the chairman of Nature Cell, highlighted during a press conference held in Washington, D.C. on the 20th that "we have successfully concluded the Phase 2 clinical trial meeting with the U.S. FDA (Food and Drug Administration), and there are no major issues preventing us from starting Phase 3 trials early next year," indicating that the company's expansion into the U.S. market is now progressing effectively. Officials from the state of Maryland and the city of Baltimore were present at the event, showing strong backing for this initiative.
Nature Cell plans to invest roughly 300 million USD (442.2 billion Korean won) in Baltimore to create the 'BIOSTAR Stemcell Campus.' The complex, covering about 9,290 square meters (2,810 pyeong), is expected to start construction early next year and finish by 2031. Upon completion, it will be capable of producing Nature Cell's degenerative arthritis stem cell treatment, 'JointStem,' for 1 million patients each year. Ra stated, "JointStem is a live-cell therapy with a limited shelf life, which makes it crucial to have a U.S. GMP (Good Manufacturing Practice) facility. By setting up manufacturing and distribution systems in Baltimore, we will establish the groundwork for full commercialization in the U.S."
Ra also outlined the outcomes of the Phase 2 clinical trial closing meeting with the FDA on the 18th. He mentioned, "The clinical part was concluded in the prior meeting, and only a few administrative tasks are left. We consider moving into Phase 3 trials next year not as an option but as a necessary progression." He further noted, "During Tuesday's meeting, both sides confirmed there are no major obstacles to proceeding to Phase 3."
Officials from the Maryland state government also participated in the event. Harry Coker, Maryland's Secretary of Commerce, remarked, "We are pleased that Nature Cell has selected Maryland," emphasizing that the state is home to more than 5,000 life sciences companies, making it one of the country's leading biotech hubs. He promised complete backing, saying, "South Korea and Maryland will generate substantial synergy in technology, investment, and research cooperation, and Nature Cell is an ideal match for this environment."
When questioned about why Baltimore was chosen, Ra stated, "The city is known for its specialized expertise, supportive policies, and research partnerships with Johns Hopkins Hospital. Moreover, using the historic 'Gaslight Square' building—built in 1883—brings significant value to advancing innovative regenerative medicine within a historic setting." He detailed plans to establish the first GMP facility, aiming to treat 20,000 patients by the end of next year, expand to a new five-story building by 2028 with an annual capacity of 200,000 patients, and reach a million-patient capacity by 2031.
Clinical findings presented at the event were also encouraging. Nature Cell disclosed five-year follow-up data for JointStem for the first time, noting, “A single injection has demonstrated long-term effectiveness over five years.” Jeong Sang-ok, CEO of Nature Cell, stated, “We confirmed 'five-year sustained effectiveness,' a level not observed in any global data submitted to the FDA. The percentage of patients requiring knee surgery in the JointStem group was as low as 3%.”
Ra said, "The active assistance provided by Maryland's state and local governments surpassed anything we have encountered in South Korea. Our goal is to save the lives of patients with untreatable conditions in the U.S. and globally using stem cell technology, and Baltimore will serve as our headquarters." He further stated, "We plan to invest more than 300 million USD by 2031 to set global benchmarks in the U.S."
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