Ji Yan Biomedical Submits Type II Drug Master File (DMF) to U.S. FDA for Gamma Delta T Cell

January 2025 — Taipei

Ji Yan Biomedical announced today the submission of a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA), detailing the manufacturing process, quality controls, and facility compliance for its unmodified gamma delta T cell (Vδ2+ γδT) platform.

The DMF submission provides comprehensive information on the ex vivo expansion and processing of investigational γδT cell therapies, including cell sourcing, serum-free culturing, activation protocols, product release testing, and cryopreservation. It also includes validation data and environmental controls from Ji Yan Biomedical’s partnered Good Tissue Practice (GTP)-compliant manufacturing facility located in Taoyuan, Taiwan.

The manufacturing described in the DMF is conducted in collaboration with HeXun Biosciences Co., Ltd., a Taiwan-based GMP- and GTP-compliant facility specializing in advanced cell processing. The filing supports Ji Yan Biomedical’s broader strategy to align its CMC (chemistry, manufacturing, and controls) infrastructure with global regulatory standards.

This filing supports the company’s long-term regulatory strategy and enables authorized reference by partners and clinical collaborators seeking to initiate FDA-regulated studies involving Ji Yan Biomedical’s cell therapy products.

“By submitting a Type II DMF, we’re advancing the regulatory readiness of our γδT cell platform and reinforcing our commitment to quality, transparency, and international collaboration,” said Dr. Ethan Shen, CEO of Ji Yan Biomedical.

The unmodified γδT cell platform is currently under preclinical investigation for its potential use in immuno-oncology applications such as glioblastoma, pancreatic cancer, and relapsed hematological malignancies.

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.