EQS-News: Biotest’s Yimmugo® launches in the United States

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.

A Breakthrough for Patients – A Milestone for Biotest
Yimmugo^® is designed to meet critical patient needs in the treatment of primary immune deficiencies, which are believed to affect one in every 1,200 people in the United States. With its entry into the U.S. market—the world’s largest plasma protein market—Biotest reinforces its mission to improve and save the lives of patients worldwide.

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).

IR contact:

Dr. Monika Baumann (Buttkereit)
Telephone: +49-6103-801-4406
Email: ir@biotest.com

PR contact:

Miriam Oehme
Telephone: +49 -152 07016 992
Email: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.com

Ordinary shares: WKN: 522720; ISIN: DE0005227201
Preference shares: WKN: 522723; ISIN: DE0005227235
Listed: Open market: Berlin, Düsseldorf, Hamburg/Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on the overall economic development and the business, earnings, financial and asset situation of Biotest AG and its subsidiaries. These statements are based on the company's current plans, estimates, forecasts and expectations and are therefore subject to risks and uncertainties that could cause the actual results to differ materially from the expected development. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.