JY BioMed Files Type II Drug Master File (DMF) with U.S. FDA for Dendritic Cell-Derived Exosome Platform

March 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 dendritic cell-derived exosome platform. This DMF, assigned Number 041487, provides comprehensive manufacturing and quality control information for investigational use of exosomes obtained from human dendritic cells.

The DMF filing includes detailed documentation on exosome isolation methods, purity profiles, particle characterization, sterility assurance, storage, and packaging. This submission supports the company’s translational research program and establishes a regulatory foundation for future preclinical and clinical collaborations under FDA oversight.

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

“This submission underscores our commitment to scientific rigor and regulatory transparency in advancing next-generation immunology platforms,” said Dr. Ethan Shen, CEO at Ji Yan Biomedical. “Dendritic cell-derived exosomes represent an emerging frontier in cell-free immunomodulation.”

This is the latest in a series of U.S. FDA DMF filings by Ji Yan Biomedical as part of its strategy to build an internationally compliant infrastructure for cellular and exosome-based product development.

Regulatory Disclaimer

The information in this Drug Master File (DMF) is confidential and available to authorized third parties through Letters of Authorization. The products described remain investigational and are not approved for clinical or commercial use.