en.Wedoany.com Reported - MEDIPOST, a South Korean company, recently announced that its knee osteoarthritis treatment product CARTISTEM® has received approval from the U.S. Food and Drug Administration (FDA) to conduct a single confirmatory Phase 3 pivotal study in the United States. This progress will help accelerate the development of CARTISTEM® in the U.S. and enhance the company's financial efficiency. MEDIPOST expects that the timeline and costs for U.S. clinical development will be significantly reduced, and the submission timeline for the Biologics License Application (BLA) may also be advanced, potentially enabling earlier entry into the U.S. market than anticipated.
CARTISTEM® is a first-in-class cell therapy product for knee osteoarthritis. MEDIPOST leveraged data from its Phase 3 clinical studies completed in South Korea and Japan for this application. Additionally, real-world evidence (RWE) data from approximately 550 South Korean patients treated with CARTISTEM® for at least three years will be included as confirmatory evidence in the dossier submitted to the FDA, supporting the expected outcomes of the U.S. Phase 3 study.
Antonio Lee, Global President of MEDIPOST, CEO of MEDIPOST K.K. (Japan), and Co-CEO of MEDIPOST Inc. (USA), stated that the time and cost advantages gained through this agreement, combined with the experience from Phase 3 trials in South Korea and Japan, will ensure the smooth progression of the U.S. Phase 3 study. He also noted that this progress, along with recent clinical successes in Japan, further advances the company's U.S. commercialization strategy and global partnership negotiations.
Founded in 2000, MEDIPOST is a global stem cell therapy company with operations spanning the discovery and clinical development of allogeneic cell therapy assets, cord blood banking, and contract development and manufacturing (CDMO) for cell and gene therapies. The company commercialized CARTISTEM® in 2012, making it the world's first approved allogeneic human umbilical cord blood-derived mesenchymal stem cell (hUCB-MSC) therapy for knee osteoarthritis. Since its launch, over 36,000 South Korean patients have been treated with the product.
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