Energenesis Biomedical and Taiwan Tanabe Seiyaku Enter Joint Development Agreement for ENERGI-F703DFU

KEY HIGHLIGHTS

• Joint development program to support process technology transfer and chemistry, manufacturing and controls (CMC) preparation for a potential new drug application (NDA) in Taiwan.
• The parties plan to evaluate subsequent manufacturing and commercialization licensing arrangements in Taiwan and selected ASEAN markets.
• The agreement strengthens regional development and commercialization readiness for ENERGI-F703DFU, currently in Phase III clinical development in Taiwan and the United States.

TAIPEI, Aug. 6, 2026 /PRNewswire/ -- Energenesis Biomedical Co., Ltd. (TWSE: 6657) today announced that it has entered into a joint development agreement with Taiwan Tanabe Seiyaku Co., Ltd. (Taiwan Tanabe), the wholly owned subsidiary of Tanabe Pharma Corporation, for ENERGI-F703DFU, Energenesis' investigational topical drug for diabetic foot ulcers (DFU).

Under the agreement, Energenesis and Taiwan Tanabe will collaborate on process technology transfer and CMC activities intended to support a potential NDA for ENERGI-F703DFU 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.

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. The companies expect the partnership to improve execution efficiency for Taiwan registration preparation, reduce downstream commercialization risk and establish a framework for broader regional market development.

"This agreement is an important milestone as ENERGI-F703DFU progresses from late-stage clinical development toward registration and commercial readiness," said Dr. Han-Min Chen, Chairman and CEO of Energenesis Biomedical. "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."

Regional Development and Commercialization Strategy

Taiwan Tanabe is a Taiwan-based group company of Tanabe Pharma Corporation. Tanabe Pharma, headquartered in Osaka, is engaged in the pharmaceuticals business centered on ethical drugs. Through its group network, Tanabe Pharma maintains pharmaceutical operations across Japan, North America, Europe and Asia.

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.

Phase III Development and Taiwan Registration Pathway

ENERGI-F703DFU 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.

About ENERGI-F703DFU

ENERGI-F703DFU is an investigational topical small-molecule gel designed to promote healing of diabetic foot ulcers 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.

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 versus 9.1% with vehicle control over a 12-week treatment period (P<0.05).

About Energenesis Biomedical

Energenesis Biomedical Co., Ltd. (TWSE: 6657) is a clinical-stage biopharmaceutical company dedicated to developing innovative therapeutics that restore cellular energy and activate intrinsic repair mechanisms. The Company combines proprietary small-molecule innovation with AI-driven drug repurposing to address significant unmet medical needs across multiple therapeutic areas, including chronic wounds, neurodegenerative diseases, and rare disorders.

The company's leading candidates include:

• ENERGI-F703DFU – Topical gel for Diabetic foot ulcers (Phase III)
• ENERGI-F703EB – Topical cream for Epidermolysis bullosa (Phase II); granted FDA Orphan Drug and Rare Pediatric Disease designations and EMA orphan designation
• ENERGI-F705PD – Oral sustained-release tablet for Parkinson's disease (Phase II IND)
• ENERGI-F701 – Topical tonic for alopecia (Phase II completed)

About Taiwan Tanabe Seiyaku

Taiwan Tanabe Seiyaku Co., Ltd., established in 1962, is a pharmaceutical company operating in Taiwan and a group company of Tanabe Pharma Corporation. For more information, visit www.tanabe.com.tw.

About Tanabe Pharma Corporation, Inc.

Tanabe Pharma Corporation is a Japan-focused, innovation-driven pharmaceutical company guided by its mission, "Creating hope for all facing illness." Founded in 1678, the Company is one of Japan's oldest pharmaceutical companies and is committed to addressing unmet medical needs through R&D, business development, and strategic partnerships with the aim of improving the lives of patients. 

For more information, visit https://www.tanabe-pharma.com/en/. 

Forward-Looking Statements

This press release contains forward-looking statements regarding clinical timelines and results, regulatory submissions and approvals, technology transfer, CMC activities, potential manufacturing and commercialization licenses, market access and future commercial opportunities. Actual results may differ materially due to clinical, regulatory, manufacturing, commercial, competitive and market risks beyond the company's control. Except as required by law, Energenesis Biomedical undertakes no obligation to update these statements.

SOURCE Energenesis Biomedical Co., Ltd.