[Asia Economy Reporter Myunghwan Lee] Kangstem Biotech announced on the 20th that it has decided to voluntarily withdraw the ½a phase clinical trial plan (IND) for the osteoarthritis treatment drug Purestem-OA Kit Injection.
The company explained, "Even when the investigational drug used in the clinical trial is manufactured using a cell bank, we decided to voluntarily withdraw in order to complete additional tests through culture methods beyond the existing test results to prove that quality and safety are identical."
Yohan Bae, Head of Clinical Development at Kangstem Biotech, stated, "The IND application for Purestem-OA Kit Injection was for the first stem cell-based combination product clinical trial after the implementation of the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Act. Considering this uniqueness, the Ministry of Food and Drug Safety conducted a thorough review of safety from multiple angles, which caused some delay in the IND approval process. Meanwhile, additional test data that were not previously required were also requested."
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