JY BioMedical Secures U.S. FDA Drug Master File (DMF) for Gamma Delta T Cell Therapy

JY BioMedical (Ji Yan Biomedical) is proud to announce that its Unmodified Vδ2+ Gamma Delta T Cells have officially obtained a U.S. FDA Drug Master File (DMF) registration (DMF Number: 041080). This milestone reinforces JY BioMedical’s commitment to regulatory excellence, innovation, and global expansion in advanced cell therapy.

The U.S. FDA DMF is a confidential document submitted to the U.S. Food and Drug Administration that provides comprehensive details on the manufacturing, processing, and quality control of drug-related substances. Gaining a DMF is an extensive and rigorous process that demands strict compliance with FDA regulations, high-quality manufacturing standards, and thorough safety evaluations. This qualification ensures that JY BioMedical’s Gamma Delta T Cell therapy meets the stringent requirements for future clinical applications and commercialization in the U.S. and global markets.

A Key Advancement for Allogeneic Cell Therapy

The Unmodified Vδ2+ Gamma Delta T Cells developed by JY BioMedical offer a highly potent, allogeneic-ready immunotherapy solution with low αβ T cell residual contamination, ensuring enhanced safety for off-the-shelf applications. These cells demonstrate high expression of CD3, Vδ2, and NKG2D, which are essential markers for robust anti-tumor activity. Furthermore, preclinical studies have confirmed their ability to target and eliminate various cancer cell lines, making them a promising candidate for future clinical trials.

Unlocking Commercialization and Clinical Development Opportunities

With FDA DMF status, JY BioMedical can now supply its Gamma Delta T Cells to global biotech and pharmaceutical companies as a raw material for new drug development. This qualification accelerates the integration of Gamma Delta T Cell therapy into future clinical trials and therapeutic applications, providing a reliable and compliant cell therapy product for companies pursuing next-generation immunotherapy solutions.

Commitment to Innovation in Cell Therapy

JY BioMedical has continuously pioneered advancements in regenerative medicine with a strong focus on cell-based therapies. In addition to Gamma Delta T Cells, the company has also obtained FDA DMF registrations for Umbilical Cord Mesenchymal Stem Cells (UC-MSC) and UC-MSC-Exosomes, further solidifying its position as a leader in cell therapy innovation.

“Securing the U.S. FDA DMF for our Unmodified Vδ2+ Gamma Delta T Cells is a major milestone for JY BioMedical,” said Benjamin Zhang, Chief Medical Officer at JY BioMedical. “This achievement not only validates our high standards in manufacturing and quality control but also opens doors for strategic collaborations in global immunotherapy development.”

Looking Ahead

JY BioMedical remains committed to advancing safe, effective, and innovative cell therapy solutions for cancer treatment. By expanding its regulatory approvals and global partnerships, the company aims to accelerate the clinical translation of its technologies and provide cutting-edge immunotherapies to patients worldwide.

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