Strategic Agreement with FBRI for R&D and Manufacturing Advancement

Tokyo & Kobe, Japan – October 21, 2024 – The Foundation for Biomedical Research and Innovation at Kobe (FBRI) and Hirosaki LI Inc. (now CynosBio Inc.) today announced the signing of a strategic agreement to advance R&D and GMP-compliant manufacturing for regenerative medicine products.

Since its founding in 2015, Hirosaki LI has collaborated closely with FBRI (formerly the Foundation for Advanced Medical Research Promotion) under Japan’s “Kobe Biomedical Innovation Cluster” initiative. The two organizations jointly developed IK-01, an autologous cultured chondrocyte product, and TR9 (Sakracy®), an epithelial sheet using amniotic substrate, which received marketing approval and reimbursement in 2022.

Under the new agreement, FBRI’s Regenerative Medicine Development Division will transfer its operational structure and manufacturing functions to CynosBio by FY2026, enabling a fully integrated system from research to commercial production.

Operating a commercial-scale, GMP-compliant Cell Processing Center (CPC), CynosBio will leverage this foundation as the first step toward global expansion of Japan’s advanced cell manufacturing technology.

The Kobe Biomedical Innovation Cluster, led by FBRI, is one of Japan’s leading centers not only for regenerative medicine research and clinical application but also for manufacturing and quality management—key capabilities for clinical trials and commercialization.

This agreement strengthens the partnership between Tokyo and Kobe and marks a major milestone in establishing Japan as a global hub for advanced regenerative medicine manufacturing.