#South Korea #Seoul #FDA Approval #CARTISTEM #MEDIPOST

MEDIPOST's FDA Breakthrough

MEDIPOST, a leader in cell therapy biotechnology, has achieved a significant milestone by securing the FDA's agreement to conduct a pivotal Phase 3 study for its knee osteoarthritis treatment, CARTISTEM®, in the United States. This agreement marks a crucial step in MEDIPOST's strategy to bring this innovative therapy to patients not only in the U.S. but also in Canada.

Accelerated Development Timeline

The agreement allows MEDIPOST to expedite CARTISTEM's development timeline in the U.S., promoting better financial efficiency for the company. With this strategic move, MEDIPOST anticipates that the overall clinical development timeline and costs in the U.S. will decrease significantly, allowing an earlier submission for its Biologics License Application (BLA). This could lead to a faster entry into the commercial market than initially projected.

MEDIPOST successfully secured the FDA's approval by utilizing compelling Phase 3 clinical study data gathered from their previous studies conducted in South Korea and Japan. In addition to this, the company will leverage Real-World Evidence (RWE) data drawn from about 550 patients who have been treated with CARTISTEM® for a minimum of three years in South Korea. This additional data will serve as confirmatory evidence to support the anticipated outcomes of the forthcoming U.S. Phase 3 study.

Leadership Insights

Antonio Lee, who serves as both the Global President of MEDIPOST and CEO of MEDIPOST K.K. in Japan, expressed enthusiasm regarding this achievement. He emphasized the importance of utilizing the advantages secured through the FDA's agreement, as well as the wealth of experience gained from conducting successful Phase 3 trials in both South Korea and Japan.

Lee pointed out that this milestone catalyzes their commercialization strategy in the U.S. while simultaneously fostering discussions surrounding global partnerships. He also acknowledged the collaborative spirit shown by the FDA in assisting novel advanced therapeutic products to navigate the complex regulatory landscape more swiftly.

About MEDIPOST

Founded in 2000, MEDIPOST has established itself as a global leader in stem cell therapy, encompassing all aspects from research discovery and clinical development to commercial applications of allogeneic cell therapies. CARTISTEM®, which received regulatory approval in 2012, is the world’s first allogeneic human umbilical cord blood-derived mesenchymal stem/stromal cell therapy product tailored for knee osteoarthritis treatment applicable to all age groups. To date, over 36,000 patients in South Korea have benefited from CARTISTEM® treatment, highlighting its positive impact on patient health and quality of life.

As MEDIPOST prepares to embark on this next phase of development, stakeholders and patients alike await the promising outcomes of this pivotal study that can potentially reshape treatment paradigms in knee osteoarthritis.