Energenesis Biomedical has signed a joint development agreement with Taiwan Tanabe Seiyaku to advance ENERGI-F703DFU, an experimental topical treatment being developed for diabetic foot ulcers (DFUs).
The agreement is focused initially on development activities needed to support a potential regulatory submission in Taiwan. The companies will work together on process technology transfer and chemistry, manufacturing and controls (CMC) activities as Energenesis moves the drug through late-stage clinical development.
The two companies also plan to discuss potential manufacturing and commercialization rights for ENERGI-F703DFU in Taiwan and selected Southeast Asian markets. Any future licensing arrangements would be subject to separate agreements and regulatory approvals.
The partnership brings together Energenesis’ drug development platform and clinical program with Taiwan Tanabe’s experience in pharmaceutical development, manufacturing and commercialization. The companies expect the collaboration to help streamline preparation for a potential new drug application (NDA) in Taiwan and provide a foundation for expanding the treatment into additional Asian markets.
ENERGI-F703DFU is being developed as a topical therapy for diabetic foot ulcers, a serious complication of diabetes that can lead to infection, tissue damage and, in severe cases, amputation. Treatment of DFUs can be challenging, particularly when wounds fail to heal normally.
Energenesis is currently evaluating ENERGI-F703DFU in a Phase III clinical trial, registered as NCT05930210, involving patients in Taiwan and the United States. The company expects to complete patient enrollment in 2027, assuming recruitment progresses as planned. This will be followed by database completion and analysis of the clinical data.
If the Phase III study achieves its predefined endpoints, Energenesis plans to prioritize preparation of a Taiwan NDA for the treatment.
Dr. Han-Min Chen, Chairman and CEO of Energenesis Biomedical, described the agreement as an important step as the program moves toward registration and potential commercial development. He said the company intends to combine its development capabilities with Taiwan Tanabe’s local pharmaceutical expertise to create a more efficient path toward a potential Taiwan approval.
For Taiwan Tanabe, the agreement expands its involvement in a late-stage drug development program targeting an area of significant unmet medical need. The company is a wholly owned subsidiary of Tanabe Pharma Corporation, which is headquartered in Osaka, Japan, and has pharmaceutical operations across Japan, North America, Europe and Asia.
Energenesis expects Taiwan Tanabe’s local capabilities in manufacturing, regulatory preparation, market access and commercialization to play an important role if the drug advances toward approval.
The companies are also looking beyond Taiwan. A successful registration could provide a starting point for potential expansion into selected ASEAN markets, although those plans remain subject to future agreements and regulatory requirements.
For Energenesis, the partnership also fits into a broader strategy of developing its pipeline toward commercialization while creating opportunities for regional licensing. The immediate focus, however, remains on completing the Phase III program and generating the clinical evidence needed to determine whether ENERGI-F703DFU can become a new treatment option for patients living with diabetic foot ulcers.