Taipei, Taiwan | October 23, 2025
YC Biotech Co., Ltd. and JY Biomed Co., Ltd. today announced the formal submission of a Pre-Investigational New Drug (Pre-IND) meeting request to the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) for Stemis™ (Human Umbilical Cord-Derived Mesenchymal Stem Cells, hUC-MSCs). The companies have also submitted a comprehensive meeting briefing package, marking a key milestone toward the product’s entry into clinical development.
Stemis™ is a cell therapy product developed from mesenchymal stem cells derived from Wharton’s Jelly of human umbilical cords, intended for the treatment of frailty syndrome in the elderly. Frailty syndrome is a complex geriatric condition arising from the decline of multiple physiological systems, characterized by decreased muscle strength, slower gait, fatigue, unintentional weight loss, and reduced daily functional capacity.
With the global population aging rapidly, frailty has become a major challenge for long-term care and healthy aging policies. The condition significantly increases the risk of falls, disability, hospitalization, and mortality, resulting in substantial medical and social burdens. There is therefore an urgent need for innovative therapeutic interventions supported by biological mechanisms to delay or reverse disease progression.
Leveraging the immunomodulatory, antioxidant, and tissue repair properties of stem cells, Stemis™ is expected to reduce chronic inflammation, preserve muscle and organ function, and restore physiological resilience—offering a promising new direction for the treatment of frailty syndrome. The planned Phase I clinical trial will primarily assess the safety and tolerability of Stemis™, with exploratory endpoints focused on improvements in physical function and quality of life.
The FDA meeting is expected to take place in late November 2025. This project represents one of the few Taiwan-based initiatives advancing a human umbilical cord stem cell therapy through the U.S. regulatory pathway. The successful submission of the Pre-IND meeting request marks an important step in aligning Taiwan’s regenerative medicine development with international regulatory standards.
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