Ji Yan Biomedical Submits Type II Drug Master File (DMF) to U.S. FDA for Umbilical Cord-Derived Mesenchymal Stem Cells

January 2025 — Taipei

Ji Yan Biomedical announced today the successful submission of a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its umbilical cord-derived mesenchymal stem cell (UC-MSC) product. This filing supports the company’s efforts to align with international regulatory standards for cell-based research materials and investigational development.

The submission, formally acknowledged under DMF Number 041078, provides comprehensive data on the source material, processing, characterization, and quality control measures associated with UC-MSCs developed at Ji Yan Biomedical. The DMF enables authorized U.S. and global regulatory references for use in Investigational New Drug (IND) applications and other applicable submissions.

“Submitting a Type II DMF to the FDA reflects our commitment to regulatory transparency and quality in the development of regenerative technologies,” said Dr. Ethan Shen, CEO at Ji Yan Biomedical. “It is a critical step toward expanding the scientific and clinical potential of our UC-MSC platform.”

Ji Yan Biomedical’s UC-MSC platform is currently being explored for its potential role in preclinical models involving tissue regeneration, immunomodulation, and neurodegenerative research. The DMF submission strengthens the company’s readiness to support global partnerships, including those in the United States and Asia-Pacific.

Regulatory Disclaimer

This Drug Master File (DMF) is a reference document submitted to the U.S. FDA and may be used by authorized third parties through Letters of Authorization (LOAs). All products and processes described remain investigational and are not approved for clinical or commercial use.