[Alpha Biz= Kim Jisun] South Korea-based biotech firm Nature Cell, a leader in stem cell therapy, announced plans to invest over KRW 400 billion (USD 300 million) in establishing a U.S. production facility for its degenerative arthritis stem cell treatment, JointStem. The move comes amid heightened tariff uncertainty, as former President Donald Trump has hinted at imposing up to 200% tariffs on pharmaceuticals within the next 12 to 18 months.



At a press briefing held near Washington, D.C., on July 9 (local time), Nature Cell Chairman Dr. Ra Jeong-chan revealed plans to build the BIOSTAR Stemcell Campus in Maryland, with a five-year investment totaling USD 300 million. The facility will focus on the research, production, and commercialization of JointStem for the U.S. market.



JointStem is a non-surgical, stem cell-based injectable therapy that regenerates damaged knee cartilage using the patient’s own stem cells.



Dr. Ra explained that the decision to invest in the U.S. was also driven by strong progress in obtaining full regulatory approval from the U.S. Food and Drug Administration (FDA). Nature Cell has already secured all three of the FDA’s major expedited programs, a milestone that Ra claims is unprecedented in the history of cell therapy development.



These include:



Regenerative Medicine Advanced Therapy (RMAT) designation, granted in October 2023 based on results from a Phase 3 clinical trial and long-term follow-up studies conducted in Korea



Breakthrough Therapy (BT) designation, awarded in March 2024



Expanded Access Program (EAP) approval, granted in June 2024, allowing compassionate use of JointStem for patients with life-threatening or no-alternative conditions prior to formal approval



“This marks the first time in history that a cell therapy drug—particularly one developed as a homegrown innovation from Korea—has received recognition from all three of the FDA’s accelerated development programs,” Dr. Ra said.



Nature Cell plans to submit its application for a U.S.-based Phase 3 clinical trial under FDA approval by late 2024 or early 2025, with the goal of completing the trial by 2027 and securing final FDA approval in 2028.

 

 

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