JY BioMed and YC Biotech Submit FDA Pre-IND Meeting Request for ExoVeris™ Exosome Therapy — A New Milestone for Taiwan’s Regenerative Medicine Advancement

Taipei, October 23, 2025

JY BioMed Co., Ltd. (集研生醫股份有限公司) and YC Biotech Co., Ltd. (昱君生技股份有限公司) have jointly submitted a Pre-Investigational New Drug (Pre-IND) Meeting request to the U.S. Food and Drug Administration (FDA) for ExoVeris™, an exosome-based therapeutic candidate, marking another important step forward in the international development of Taiwan’s regenerative medicine sector.

ExoVeris™ is an exosome product derived from human umbilical cord Wharton’s Jelly mesenchymal stem cells (UC-MSCs). Produced through a proprietary, advanced purification process, ExoVeris™ retains the intercellular communication and repair-modulating functions characteristic of MSC-derived exosomes. It is being developed as a novel therapeutic approach for neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis (ALS) — conditions characterized by progressive neuronal loss leading to cognitive, motor, and functional decline. Current treatment options mainly slow disease progression but remain unable to reverse neurodegeneration.

The planned Phase I clinical trial will begin in healthy volunteers to assess safety and tolerability, followed by expansion into patient populations with neurodegenerative disorders.

Through formal engagement with the FDA, JY BioMed aims to establish a clear regulatory and development strategy to support a subsequent IND submission and the advancement of ExoVeris™ into clinical stages.

The ExoVeris™ program represents a significant step forward for Taiwan’s regenerative medicine ecosystem, transitioning from mesenchymal stem cell therapy toward an exosome-based therapeutic platform. This initiative demonstrates both the innovation capacity of local scientific teams and their commitment to international regulatory alignment, as Taiwan-originated developers continue to pursue global market pathways for next-generation biomedicine.

About JY BioMed

JY BioMed is a biotechnology company dedicated to the research, development, and commercialization of cell- and exosome-based therapeutics for oncology, immunology, and regenerative medicine. Our pipeline includes programs in mesenchymal stem cells (MSCs), dendritic cell cancer vaccines, γδ T cells, NK cell therapy, and antibody-drug conjugates (ADCs), supported by partnerships with leading academic and clinical institutions.

Disclaimer

ExoVeris™ is an investigational exosome therapy product that has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Its safety and efficacy have not been established. Any forward-looking statements in this release, including those related to development plans, regulatory timelines, or therapeutic potential, are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied. JY BioMed undertakes no obligation to update or revise such statements based on new information or future events.