JY BioMedical Secures U.S. FDA Drug Master File (DMF) Registration for Human Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)

JY BioMedical (Ji Yan Biomedical) proudly announces that its Human Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs) have successfully obtained U.S. FDA Drug Master File (DMF) registration (DMF Number: 041078). This prestigious qualification underscores JY BioMedical’s dedication 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. Achieving FDA DMF registration is a rigorous and demanding process requiring strict adherence to FDA regulations, extensive documentation, and stringent quality control standards. This certification is granted to only a select number of companies worldwide, demonstrating JY BioMedical’s high level of excellence in cell therapy development.

Advancing Stem Cell Therapy with UC-MSCs

Human Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs) are at the forefront of regenerative medicine due to their remarkable anti-inflammatory, immunomodulatory, and regenerative properties. With FDA DMF registration, JY BioMedical’s UC-MSCs can now be provided to biotechnology and pharmaceutical companies as a qualified raw material for developing innovative cell-based therapies. This milestone accelerates the clinical translation of UC-MSC-based treatments in areas such as tissue repair, immune regulation, and regenerative medicine.

A Landmark Achievement in Cell Therapy Development

JY BioMedical has consistently been a leader in advancing cell and regenerative therapies. In addition to UC-MSCs, the company has also obtained FDA DMF registrations for UC-MSC-derived exosomes and Gamma Delta T Cells, reinforcing its position as a global innovator in next-generation cellular treatments.

“Achieving U.S. FDA DMF registration for our UC-MSCs is a significant milestone for JY BioMedical,” said Dr. Benjamin Zhang, Chief Medical Officer at JY BioMedical. “This achievement highlights our unwavering commitment to high-quality manufacturing, scientific innovation, and regulatory compliance. We look forward to collaborating with international partners to advance the clinical application of UC-MSC-based therapies.”

Future Outlook

JY BioMedical remains dedicated to pioneering innovation in stem cell therapy, expanding regulatory approvals, and fostering 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 products, please visit https://www.jy-biomed.com.