EQS-News: Biotest AG
/ Key word(s): Product Launch
PRESS RELEASE
Biotest's Yimmugo® launches in the United States
Dreieich, Germany, October 9, 2025. Biotest AG, a specialist in innovative haematology, clinical immunology and intensive care medicine and part of Grifols, a global healthcare company and leading producer of plasma-derived medicines, proudly announces the official launch of Yimmugo®, its innovative intravenous polyvalent human normal immunoglobulin (IVIg) to treat primary immunodeficiencies, in the United States. This is a significant milestone in the company's global growth strategy and represents the first U.S.-approved medicine in Biotest's portfolio. This important achievement is made possible through the close collaboration with Kedrion Inc., a recognized leader in plasma-derived therapies, which will become Biotest's U.S. distribution partner for this treatment.
Yimmugo® is produced in Biotest's "Next Level" production facility in Dreieich, Germany, using a state-of-the-art manufacturing process. The treatment was successfully introduced in Europe at the end of 2022 and will now reach U.S. patients, following FDA approval in 2024. "This launch is a major step forward in expanding access to treatment for U.S. patients living with primary immunodeficiencies. It also reinforces our commitment to broadening the reach of our therapies," said Dr. Jörg Schüttrumpf, CEO of Biotest AG. "Our collaboration with Kedrion ensures that Yimmugo® reaches those who need it most, backed by Kedrion's deep expertise and trusted commercial network in the United States." The U.S. launch of Yimmugo® represents a cornerstone in Biotest's long-term strategy and highlights the company's continuous growth trajectory. It demonstrates Biotest's commitment to innovation, patient focus, and international expansion. "With Yimmugo® now available in the U.S., Biotest takes a bold step into the future," added Enrico D'Aiuto, Head of Commercial Operations at Biotest. "We are proud of this achievement, grateful to our teams and partners, and optimistic about the impact Yimmugo® will have on patients' lives."
About Biotest Biotest is a supplier of biological medicines derived from human plasma. With a value chain ranging from preclinical and clinical development to global marketing, Biotest specialises primarily in the fields of clinical immunology, haematology and intensive care and emergency medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin, which are produced from human blood plasma and used to treat diseases of the immune system or the blood-forming systems. Biotest employs more than 2,500 people worldwide. Since May 2022, Biotest has been part of the Grifols Group, Barcelona, Spain (www.grifols.com).
Dr. Monika Baumann (Buttkereit)
Miriam Oehme Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.com Ordinary shares: WKN: 522720; ISIN: DE0005227201
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