JY BioMedical Achieves U.S. FDA DMF Registration for Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes

JY BioMedical (Ji Yan Biomedical) proudly announces that its Human Umbilical Cord Mesenchymal Stem Cell (UC-MSC)-Derived Exosomes have successfully obtained U.S. FDA Drug Master File (DMF) registration (DMF Number: 041203). This prestigious qualification highlights JY BioMedical’s commitment to regulatory compliance, product safety, and global expansion in regenerative medicine.

What is the U.S. FDA DMF?

The U.S. FDA DMF (Drug Master File) is a confidential document submitted to the FDA that provides comprehensive details on manufacturing, processing, and quality control for drug-related substances. Gaining FDA DMF registration is a highly rigorous and demanding process that requires strict adherence to FDA regulations, extensive documentation, and stringent quality control standards. Few companies worldwide achieve this certification, demonstrating the high level of excellence JY BioMedical maintains in its cell-derived product development.

Pioneering Innovation in Exosome-Based Therapy

Exosomes derived from human umbilical cord mesenchymal stem cells (UC-MSCs) have gained significant attention in regenerative medicine due to their potent anti-inflammatory, tissue-regenerating, and immune-modulating properties. With FDA DMF status, JY BioMedical’s UC-MSC-derived exosomes can now be supplied to biotech and pharmaceutical companies as a certified raw material for new drug development. This qualification accelerates the integration of exosome-based therapies into clinical trials, supporting a broad range of applications in regenerative medicine, tissue repair, and immunotherapy.

A Key Milestone in Global Cell Therapy Development

JY BioMedical has consistently been at the forefront of cell and exosome-based innovation. In addition to UC-MSC-derived exosomes, the company has also secured FDA DMF registrations for Umbilical Cord Mesenchymal Stem Cells (UC-MSC) and Gamma Delta T Cells, solidifying its reputation as a leader in next-generation regenerative therapies.

“Achieving U.S. FDA DMF registration for our UC-MSC-derived exosomes is a major milestone for JY BioMedical,” said Benjamin Zhang, Chief Medical Officer at JY BioMedical. “This recognition reflects our dedication to high-quality manufacturing, scientific excellence, and global regulatory compliance. We look forward to collaborating with international partners to advance the clinical translation of exosome-based therapies.”

Future Outlook

JY BioMedical remains committed to driving innovation in exosome and cell therapy research, expanding its regulatory approvals and industry collaborations to accelerate the commercialization of next-generation regenerative medicine solutions.

For more information about JY BioMedical and its FDA DMF-qualified cell therapy and exosome products, please visit https://www.jy-biomed.com.