Energenesis Biomedical and Taiwan Tanabe Seiyaku Enter Joint Development Agreement for Diabetic Foot Ulcer Candidate ENERGI-F703DFU
核心洞察
Energenesis Biomedical (搜索) and Taiwan Tanabe Seiyaku (搜索) have entered a joint development agreement for ENERGI-F703DFU (搜索), an investigational topical gel for diabetic foot ulcers (搜索) currently in Phase III trials.
The collaboration will focus on process technology transfer and CMC preparation to support a potential new drug application in Taiwan, with plans to evaluate manufacturing and commercialization licenses in Taiwan and ASEAN markets.
A post-hoc analysis of the Phase II study showed complete wound closure rates of 36.7% with ENERGI-F703DFU (搜索) versus 9.1% with vehicle control over 12 weeks (P<0.05).
Energenesis Biomedical (搜索) Co., Ltd. (TWSE: 6657) announced on August 6, 2026, that it has entered into a joint development agreement with Taiwan Tanabe Seiyaku (搜索) Co., Ltd., the wholly owned subsidiary of Tanabe Pharma Corporation (搜索), for ENERGI-F703DFU (搜索), an investigational topical drug for diabetic foot ulcers (搜索) (DFU). The partnership aims to advance the late-stage clinical candidate toward registration and commercial readiness in Taiwan and selected ASEAN markets.
Under the agreement, Energenesis and Taiwan Tanabe will collaborate on process technology transfer and chemistry, manufacturing and controls (CMC) activities intended to support a potential new drug application (NDA) for ENERGI-F703DFU (搜索) in Taiwan. The parties also plan to advance discussions regarding future manufacturing and commercialization licenses in Taiwan and selected ASEAN markets, subject to separate definitive agreements and applicable regulatory approvals.
"This agreement is an important milestone as ENERGI-F703DFU (搜索) progresses from late-stage clinical development toward registration and commercial readiness," said Dr. Han-Min Chen, Chairman and CEO of Energenesis Biomedical (搜索). "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 program and generating the evidence required to bring a new treatment option to patients with diabetic foot ulcers (搜索)."
Phase III Development and Regulatory Pathway
ENERGI-F703DFU (搜索) is currently being evaluated in a Phase III clinical trial (NCT05930210) in Taiwan and the United States. Subject to continued recruitment progress, Energenesis expects to complete Phase III patient enrollment in 2027, followed by database completion and data analysis. If the trial meets its prespecified endpoints, the company plans to prioritize preparation of a Taiwan NDA.
Clinical Evidence from Phase II
In a post-hoc analysis of the Phase II study (NCT02672436), patients meeting the current Phase III eligibility criteria achieved complete wound closure rates of 36.7% with ENERGI-F703DFU (搜索) versus 9.1% with vehicle control over a 12-week treatment period (P<0.05). These results provide a foundation for the ongoing Phase III program.
Mechanism of Action
ENERGI-F703DFU (搜索) is an investigational topical small-molecule gel designed to promote healing of diabetic foot ulcers (搜索) by modulating cellular energy pathways. The drug candidate is intended to increase intracellular ATP levels at the wound site, support epithelial cell migration, and activate intrinsic repair mechanisms.
Strategic Rationale
The collaboration brings together Energenesis' proprietary ENERGI drug development platform and late-stage clinical program with Taiwan Tanabe's local pharmaceutical development, manufacturing, and commercial capabilities. For Energenesis, the collaboration is expected to provide access to established local capabilities in manufacturing, regulatory preparation, market access, and commercialization. A successful Taiwan registration could also support subsequent ASEAN expansion and the company's broader out-licensing strategy.
Taiwan Tanabe Seiyaku (搜索), established in 1962, is a pharmaceutical company operating in Taiwan and a group company of Tanabe Pharma Corporation (搜索). Tanabe Pharma, headquartered in Osaka and founded in 1678, is one of Japan's oldest pharmaceutical companies and is engaged in the pharmaceuticals business centered on ethical drugs, with operations across Japan, North America, Europe, and Asia.
Broader Pipeline
Energenesis Biomedical (搜索) is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics that restore cellular energy and activate intrinsic repair mechanisms. Beyond ENERGI-F703DFU (搜索), the company's pipeline includes ENERGI-F703EB, a topical cream for epidermolysis bullosa (搜索) in Phase II that has received FDA Orphan Drug and Rare Pediatric Disease designations as well as EMA orphan designation; ENERGI-F705PD, an oral sustained-release tablet for Parkinson's disease (搜索) at the Phase II IND stage; and ENERGI-F701, a topical tonic for alopecia (搜索) that has completed Phase II.