JY BioMed Submits Type II Drug Master File (DMF) to U.S. FDA for UC-MSC-Derived Exosome Manufacturing

January 2025 — Taipei

Ji Yan Biomedical (JY BioMed) announced today the successful submission of a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its human umbilical cord-derived mesenchymal stem cell (UC-MSC)-derived exosome product. The DMF, assigned Number 041203, documents the manufacturing processes, quality controls, and storage protocols for Ji Yan Biomedical’s investigational exosome platform.

This submission provides regulatory transparency to authorized stakeholders and supports the company’s broader strategy to advance next-generation extracellular vesicle (EV) technologies for research and potential therapeutic applications.

The UC-MSC-derived exosomes are currently under preclinical evaluation for their potential role in tissue repair, inflammatory modulation, and neurodegenerative research models.

“Submitting a Type II DMF for our UC-MSC-derived exosomes reflects our commitment to international quality standards and regulatory preparedness,” said Dr. Ethan Shen, CEO at Ji Yan Biomedical. “This milestone strengthens our global platform for exosome research and translational innovation.”

The DMF will be available for authorized reference through Letters of Authorization (LOAs) for future Investigational New Drug (IND) applications and related regulatory submissions.

Regulatory Disclaimer

This Drug Master File (DMF) is a reference document submitted to the U.S. FDA and may be used by authorized third parties through Letters of Authorization (LOAs). All products and processes described remain investigational and are not approved for clinical or commercial use.