JY BioMed has filed a U.S. Drug Master File for its GDT cell-derived exosomes, expanding the manufacturing and quality documentation supporting its platforms.

JY BioMed announces dual FDA Type II Drug Master File acceptance in January 2025, covering UC-MSC and UC-MSC-derived Exosomes. Establishing a fully traceable, vertically integrated regulatory platform, JY BioMed is advancing toward IND submission and positioning as an early leader in the exosome therapeutics space.