Taipei, Taiwan | September 18, 2025
Taiwanese biotech teams continue to strengthen their presence in the international regenerative medicine arena. YC Biotech Co., Ltd. and JY Biomed Co., Ltd. recently submitted a Pre-Investigational New Drug (Pre-IND) meeting request to the U.S. Food and Drug Administration (FDA) for ExoVeris™, advancing the product toward clinical development.
ExoVeris™ is an exosome-based therapy derived from human umbilical cord Wharton’s Jelly mesenchymal stem cells (UC-MSCs). Produced through a proprietary advanced purification process, these exosomes carry intercellular signaling and tissue repair regulatory functions, with potential applications in neurodegenerative diseases. Such conditions—including Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis (ALS)—are characterized by progressive neuronal loss, leading to deterioration in memory, motor function, and daily living abilities. Current treatments primarily slow disease progression, with no therapies capable of reversing the course.
The clinical development plan will begin with a Phase I trial in healthy volunteers to assess safety and tolerability, followed by gradual expansion into patient populations affected by neurodegenerative diseases.
Through formal engagement with the FDA, the companies aim to align on development strategy and streamline the subsequent IND submission process.
The development of ExoVeris™ represents a significant milestone for Taiwan’s regenerative medicine sector, transitioning from mesenchymal stem cell therapies to an exosome-based platform. This initiative not only demonstrates the strength of domestic R&D capabilities but also reflects the commitment of local teams to advance innovative biopharmaceutical products in compliance with international regulatory standards, paving the way for global market entry.
*Image AI-generated, for illustration purposes only