Grifols’ Biotest launches Yimmugo^® in the United States

Barcelona, Spain, October 9, 2025 - Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), a global healthcare company and leading producer of plasma-derived medicines and innovative diagnostic solutions, today announced that Yimmugo^®, an innovative intravenous immunoglobulin (IVIg) therapeutic, produced by Biotest – a Grifols Group company – will officially launch in the United States for the treatment of primary immunodeficiencies (PID).

Following FDA approval for U.S. commercialization earlier in 2024, the first for a Biotest medicine, Yimmugo will now be available to help address the growing number of patients living with primary immunodeficiencies and other medical conditions in the country. It is estimated that one in every 1,200 people¹ in the U.S. is affected by PID, a condition where the body’s immune system’s ability to fight infections and diseases is weakened or does not function properly.

Developed by Biotest, Yimmugo is manufactured using a state-of-the-art process at the company’s FDA-certified “Next Level” production facility in Dreieich, Germany. Already approved and successfully launched in Europe in 2022, the U.S. introduction of Yimmugo is expected to significantly contribute to Grifols Group’s sales and support the company’s future growth strategy.

Grifols has built a strong portfolio of industry-leading immunoglobulin therapies, including both intravenous and subcutaneous formulations. Global demand for immunoglobulin treatments continues to rise, with a projected compound annual growth rate (CAGR) of 6.9%, reaching an estimated market size of $36.7 billion in 2034, up from $20.1 billion in 2025².  

“The U.S. launch of Yimmugo marks a cornerstone in Biotest’s long-term strategy and highlights the company’s continuous growth trajectory,” said Dr. Jörg Schüttrumpf, Chief Scientific Innovation Officer at Grifols and CEO of Biotest AG. “It also demonstrates Grifols’ and Biotest’s shared commitment to innovation and to improving the lives of people worldwide by expanding access to care.”

Yimmugo will be distributed in the United States by Kedrion Inc., a recognized leader in plasma-derived therapies.

About Yimmugo^® (IgG Next Generation)

Yimmugo is a newly developed polyvalent immunoglobulin G preparation from human blood plasma for intravenous administration (IVIg). The sugar-free ready-to-use solution is approved in the US for substitution therapy in primary antibody deficiency syndromes. Yimmugo is the first approved product from the new Biotest Next Level production facility. The modern production process stands for the highest product quality and an extremely responsible use of resources.

INDICATIONS AND USAGE

YIMMUGO^® (immune globulin intravenous, human – dira) is a 10% immune globulin (Ig) liquid indicated for the treatment of primary humoral immunodeficiency in patients 2 years of age and older.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE

• Thrombosis may occur with Ig intravenous (IGIV) products, including YIMMUGO.
• Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and failure occur more commonly in patients receiving IGIV products containing sucrose. YIMMUGO does not contain sucrose.
• For patients at risk of thrombosis, renal dysfunction, or renal failure, administer YIMMUGO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

CONTRAINDICATIONS

YIMMUGO is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human Ig and in patients with immunoglobulin A (IgA) deficiency who have antibodies against IgA and a history of hypersensitivity.

WARNINGS AND PRECAUTIONS

Severe hypersensitivity reactions, including anaphylaxis, have been reported after administration. In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. YIMMUGO contains ≤300 mcg/mL of IgA. Patients with known antibodies to IgA may be at greater risk.

Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to IGIV treatment. Risk factors for hemolysis include high doses and non-O blood group. Monitor patients for hemolysis.

Renal failure: Monitor renal function, including blood urea nitrogen (BUN) and serum creatinine, and urine output in patients at risk of developing acute renal failure.

Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IGIV treatment, including YIMMUGO.

Aseptic meningitis syndrome may occur in patients receiving IGIV treatment, especially with high doses or rapid infusion.

Transfusion-related acute lung injury: Monitor patients for pulmonary adverse reactions.

Transmissible infectious agents: YIMMUGO is made from human plasma and may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease agent.

Interference with laboratory tests: After infusion of Ig, transitory rise of various passively transferred antibodies in the blood may yield positive serological results, with potential for misleading interpretation.

ADVERSE REACTIONS

The most common adverse reactions occurring in ≥5% of patients were headache, upper respiratory tract infections, fatigue, nausea, and increased blood pressure.

To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc. at 1-855-3KDRION (1-855-353-7466) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for complete prescribing details, including Boxed Warning.

References: 1. YIMMUGO [prescribing information]. Kedrion Biopharma Inc.; 2024. 2. Duellberg C, Hannappel A, Kistner S, Maneg O. Biochemical characterization of a new 10% IVIG preparation [IgG Next Generation (BT595)/Yimmugo^®] obtained from a manufacturing process preserving IgA/IgM potential of human plasma. Drugs R D. 2023;23(3):245-255.