Ji Yan Biomedical Receives FDA IND Clearance for Umbilical Cord-Derived MSC Investigational Study

April 2025 — Taipei

Ji Yan Biomedical today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance for its umbilical cord-derived mesenchymal stem cell (UC-MSC) program. The clearance, issued by the Center for Biologics Evaluation and Research (CBER), allows the company to proceed with a first-in-human study under IND number 031083.0.

This regulatory milestone marks a significant advancement in Ji Yan Biomedical’s regenerative medicine platform, which focuses on exploring the potential of allogeneic MSCs for applications in tissue repair and immune modulation.

The IND clearance enables the initiation of clinical evaluation to assess the safety and feasibility of the company’s UC-MSC candidate in a regulated, Good Clinical Practice (GCP)-compliant setting. The study will be conducted in accordance with applicable FDA regulations, international standards, and internal quality systems.

“We are grateful for the FDA’s acceptance of our IND submission and are proud of our team’s efforts to reach this important milestone,” said Dr. Ethan Shen, CEO of Ji Yan Biomedical. “This clearance brings us one step closer to translating our scientific research into meaningful clinical outcomes.”

Ji Yan Biomedical will continue to provide updates on clinical progress as the study advances.

Status

• IND Number: 031083.0

• CBER Receipt Date: March 28, 2025

• Study Approval Notice: “Study may proceed”