Nature Cell’s JointStem Becomes the First Korean Company to Acquire Breakthrough Therapy Designation from the U.S. FDA
-The first Korean company granted Breakthrough Therapy Designation (BTD) from the U.S. FDA
-Clinical trials and results from a three-year follow-up show significant improvements compared to existing treatments
-The BTD designation, achieved following RMAT approval, accelerates JointStem 's pathway to FDA approval
LOS ANGELES, CA / ACCESS Newswire / March 22, 2025 /Nature Cell Co., Ltd., a leading biotechnology company announced on March 20th that JointStem, currently undergoing clinical trials in the United States, has been granted Breakthrough Therapy Designation (BTD) from the U.S. FDA- the first instance for a Korean company in the field of cell therapy.
The Breakthrough Therapy Designation is granted by the FDA to clinical trials that demonstrate a clinically significant improvement over existing treatment options. This designation provides companies with the full benefits of Fast Track designation while also facilitating direct engagement with senior FDA officials to expedite drug development and approval processes.
The receipt of BTD significantly increases the likelihood of product approval and reduces the regulatory timeline, thereby accelerating the pathway to commercialization. Furthermore, the structured support from the FDA enhances the credibility of the treatment and contributes to the company 's overall value.
For instance, Imbruvica, a targeted cancer therapy developed by AbbVie and Janssen Biotech, received BTD in 2013 and was designated for priority review, leading to FDA accelerated approval within one year. This achievement made it the first approved BTK inhibitor in the world and has been a valuable financial asset for the companies involved. Similarly, Keytruda, an immunotherapy developed by Merck (MSD), also received BTD and priority review, resulting in accelerated approval in approximately one year.
JointStem is distinguished as the world 's first autologous adipose-derived mesenchymal stem cell therapy specifically intended for patients with severe knee osteoarthritis. A single intra-articular injection has been shown to stimulate cartilage regeneration, significantly reduce pain, and improve joint function for at least three years, potentially delaying or eliminating the need for knee replacement surgery.
Following its designation as a Regenerative Medicine Advanced Therapy (RMAT) by the FDA in October 2023, JointStem has now received BTD based on results from its Phase 3 clinical trials and long-term follow-up studies conducted in South Korea. This recognition further validates the safety and efficacy of the therapy.
According to the 2019 Global Burden of Disease Study published in the journal Arthritis &Rheumatology, an estimated 51.87 million individuals in the United States were affected by knee osteoarthritis in 2019. In South Korea, data from the Health Insurance Review and Assessment Service (HIRA) indicates that in 2023, over 3 million patients sought medical treatment for knee osteoarthritis, with 72,845 undergoing knee replacement surgery in 2022, demonstrating a consistent upward trend.
Dr. Jeong Chan Ra, chairman of Nature Cell, stated, "The Breakthrough Therapy Designation (BTD) for JointStem is especially significant as it was granted based on the results of a Phase 3 clinical trial and a three-year long-term follow-up study conducted in alignment with the guidelines of the Korea 's Ministry of Food and Drug Safety (MFDS). This recognition affirms that Korea 's regulatory science meets global standards."
Contact Info
Email: janeshin@stemcellbio.com
SOURCE: Nature Cell
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