JY BioMed Submits Type II Drug Master File (DMF) to U.S. FDA for Hair Follicle Mesenchymal Stem Cell-Derived Exosomes

March 2025 — Taipei

Ji Yan Biomedical (JY BioMed) announced the successful submission of a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its hair follicle mesenchymal stem cell (HF-MSC)-derived exosome platform. The filing, registered under DMF Number 041488, provides comprehensive data on the manufacturing, characterization, and quality control procedures for investigational exosome products derived from HF-MSCs.

This submission marks a significant milestone in the development of cell-free biologics at Ji Yan Biomedical and reflects the company’s commitment to regulatory transparency and compliance in advanced extracellular vesicle (EV) research.

The HF-MSC-derived exosome platform is currently under preclinical evaluation for its potential applications in regenerative science, tissue repair, and immunological modulation.

“This FDA filing is an important step toward building an internationally compliant foundation for our exosome-based research,” said Dr. Ethan Shen, CEOr at Ji Yan Biomedical. “HF-MSC-derived exosomes represent an innovative area in regenerative medicine, and we are committed to rigorous quality standards in their development.”

The DMF is available for authorized reference through Letters of Authorization (LOAs) submitted to future IND or BLA applications.

Regulatory Disclaimer

This Drug Master File (DMF) is submitted to the FDA for regulatory reference only. Products described are investigational and not approved for clinical or commercial use. DMF access is granted to authorized parties via Letters of Authorization.