Taipei, Taiwan | January 19, 2026
YC Biotech announced today that its strategic partner, JY-Biomed, has received official notification from the U.S. Food and Drug Administration (FDA) regarding the Investigational New Drug (IND) application for Stemis™ (IND 32415). The FDA has cleared the IND, allowing the clinical trial to proceed. Following this significant regulatory greenlight, YC Biotech will assist JY-Biomed in leveraging this US clearance to accelerate the initiation of clinical trials in Taiwan.
Stemis™ is an innovative mesenchymal stem cell therapy designed for tissue regeneration. The clearance of this IND validates the robustness of the safety data and the scientific rationale presented to the FDA. YC Biotech indicated that this approval serves as a critical foundation for the upcoming submission to the Taiwan Food and Drug Administration (TFDA). The companies aim to initiate patient enrollment at major medical centers in Taiwan, offering new therapeutic options to local patients.
“Securing the IND clearance for IND 32415 is a pivotal achievement for our partnership with JY-Biomed,” said a spokesperson for YC Biotech. “This success demonstrates our capability to navigate complex international regulatory landscapes and sets the stage for future multi-regional clinical development.”
About YC Biotech
YC Biotech is a premier Contract Research Organization (CRO) specializing in regulatory strategy and clinical trial management, dedicated to bringing innovative therapies to the global market.
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