Energenesis Biomedical has entered into a joint development agreement with Taiwan Tanabe Seiyaku, the wholly owned subsidiary of Tanabe Pharma Corporation, for ENERGI-F703DFU, its investigational topical drug for diabetic foot ulcers (DFUs).
Under the agreement, Energenesis and Taiwan Tanabe will collaborate on process technology transfer and manufacturing and controls (CMC) activities to support a potential New Drug Application (NDA) for ENERGI-F703DFU in Taiwan.
The companies also plan to advance discussions on future manufacturing and commercialization licenses in Taiwan and selected ASEAN markets, subject to separate definitive agreements and applicable regulatory approvals.
The collaboration brings together Energenesis’ proprietary ENERGI drug development platform and late-stage clinical programme with Taiwan Tanabe’s local pharmaceutical development, manufacturing and commercialization capabilities.
The partnership is expected to improve execution efficiency for Taiwan registration preparation, reduce downstream commercialization risk and establish a framework for broader regional market expansion.
“This agreement is an important milestone as ENERGI-F703DFU progresses from late-stage clinical development toward registration and commercial readiness. By combining Energenesis’ development expertise with Taiwan Tanabe’s pharmaceutical capabilities, we aim to establish an efficient pathway for a potential Taiwan NDA and prepare for broader access in Asia,” said Dr. Han-Min Chen, Chairman and CEO of Energenesis Biomedical.
ENERGI-F703DFU is an investigational topical small-molecule gel designed to promote the healing of diabetic foot ulcers by modulating cellular energy pathways. It is intended to increase intracellular ATP levels at the wound site, support epithelial cell migration and activate intrinsic repair mechanisms.
In a post-hoc analysis of the Phase II study, patients meeting the current Phase III eligibility criteria achieved complete wound closure rates of 36.7% with ENERGI-F703DFU, compared with 9.1% for the vehicle control over a 12-week treatment period.
The drug is currently being evaluated in a Phase III clinical trial in Taiwan and the United States. Subject to continued recruitment progress, Energenesis expects to complete Phase III patient enrolment in 2027, followed by database completion and data analysis. If the trial meets its prespecified endpoints, the company plans to prioritize filing an NDA in Taiwan.
