October 19, 2026Products

AGC Biologics to Support Development and Manufacturing of Flen Health’s Next-Generation Enzyme Therapy for Diabetic Foot Ulcers

-Providing process development and GMP manufacturing services for recombinant enzymes-

AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO) within the AGC Group, has entered into an agreement with Belgian biopharmaceutical company Flen Health to provide process development and GMP* manufacturing services for recombinant enzymes for use in a next-generation therapy for diabetic foot ulcers.
At its Heidelberg site in Germany, AGC Biologics will carry out process development and manufacturing activities for lactoperoxidase and glucose oxidase. This work will support Flen Health's planned Investigational New Drug (IND) application and Phase II clinical trial in the United States.

Advancing a Next-Generation Enzyme Therapy for Diabetic Foot Ulcers
In 2024, approximately 589 million adults worldwide, or about one in nine, were living with diabetes. Its prevalence is projected to rise further.
Diabetic foot ulcers are chronic wounds that develop on the feet of people with diabetes. More than one in five people with diabetes are estimated to be at risk of developing a diabetic foot ulcer during their lifetime. Effective treatment options remain limited, creating a strong need for new therapeutic approaches.
To address this unmet medical need, Flen Health is developing a next-generation therapy using recombinant enzymes. The therapy is based on Flaminal®, Flen Health’s wound treatment gel that combines enzymes and alginate and is marketed primarily in Europe.

Expanding the Collaboration from a Feasibility Program to GMP Manufacturing
AGC Biologics and Flen Health began a feasibility program in July 2025. At its Heidelberg site, AGC Biologics has since undertaken technology transfer for the manufacturing processes of lactoperoxidase and glucose oxidase. It has also developed cultivation and purification processes and implemented analytical methods.
Under the new agreement, the collaboration will advance to the next stage, covering process development, scale-up and GMP manufacturing. AGC Biologics plans to manufacture the recombinant enzymes at the 100-liter and 1,000-liter scales.

AGC Biologics Heidelberg Site

Development Activities at the Heidelberg Site

Exterior view of the AGC Biologics Heidelberg Site A researcher working on development at the Heidelberg site

Under its medium-term management plan, AGC plus-2026, the AGC Group has defined three social values that it aims to create through its products and technologies. One of these values is “Well-being.” The Group aims to contribute to safe, secure and healthy living by ensuring the stable provision of products and services essential to daily life and healthcare.
Through its Life Science business, the AGC Group provides CDMO services for biopharmaceuticals and a wide range of other modalities. By supporting customers from early-stage development through commercial production, the Group aims to contribute to the health of people worldwide.


〈Notes〉

*

GMP: Good Manufacturing Practice. GMP refers to standards designed to ensure pharmaceutical quality and safety by controlling the entire process from the receipt of raw materials through manufacturing and shipment.

About Flen Health
Flen Health is a biopharmaceutical company dedicated to developing innovative therapies for unmet needs in wound care. Founded in 2000 and headquartered in Kontich, Belgium, the company has more than 25 years of experience delivering trusted wound and skin healing solutions across Europe and in more than 40 countries worldwide. Flen Health is now leveraging this expertise to bring its novel therapeutics to the U.S. market. For more information, visit www.flenhealth.com.

About the AGC Group
AGC Inc. is a global materials company operating across a wide range of products and industries. Founded in 1907 with flat glass production as its original business, AGC has expanded its operations in line with changing societal needs, providing materials and solutions based on its core material and production technologies. Today, the AGC Group operates in more than 30 countries and regions, with businesses spanning glass, electronics, chemicals, life science, and ceramics. Guided by its purpose, “AGC, an everyday essential part of our world,” the Group provides value to society through the pursuit of innovation.

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