Energenesis Biomedical has signed a joint development agreement with Taiwan Tanabe Seiyaku for its investigational topical drug ENERGI-F703DFU to treat diabetic foot ulcers (DFUs).
The collaboration will focus on process technology transfer and activities relating to chemistry, manufacturing and controls (CMC) to support a possible new drug application (NDA) in Taiwan for the drug.
Energenesis' ENERGI-F703DFU is currently in Phase III clinical development in both Taiwan and the US.
The two companies have also stated their intention to discuss future licensing for manufacturing and commercialisation in Taiwan and selected ASEAN markets, should agreements and regulatory approvals be reached.
The initiative combines Energenesis’ ENERGI drug development platform and ongoing clinical programme with Taiwan Tanabe Seiyaku’s capabilities in pharmaceutical development, production, and commercial operations within Taiwan.
Energenesis Biomedical chairman and CEO Dr Han-Min Chen said: “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.
“We remain focused on completing the Phase III programme and generating the evidence required to bring a new treatment option to patients with diabetic foot ulcers.”
The partnership is expected to enhance efficiency in preparing for the registration process in Taiwan, aim to mitigate commercialisation risk, and provide a basis for expanded regional market access.
For Energenesis, working with Taiwan Tanabe is anticipated to supply established local experience in manufacturing, regulatory affairs, and commercial access.
Energenesis Biomedical expects to complete enrolment for the Phase III study in 2027, after which it will progress to data analysis. If the trial reaches its specified endpoints, preparation of a Taiwan NDA would be prioritised.
ENERGI-F703DFU is a topical small-molecule gel that is intended to promote healing of DFUs by modulating cellular energy pathways.
