Human normal immunoglobulin(Takeda)

Sponsorship of educational satellite symposium and the support of data analysis and publication of the 2025 IgNS Patient 360 Longitudinal Survey results reflect GC Biopharma's commitment to advancing IVIG safety, education, and patient-centered care TEANECK, N.J., Nov. 6, 2025 /PRNewswire/ -- GC Biopharma USA, Inc., a leader in plasma-derived products, announced today its support of data analysis and publication of the 2025 Immunoglobulin National Society (IgNS) Patient 360 Longitudinal Survey through a research grant. Two IgNS-led posters presented new findings from this ongoing initiative, which explores patient outcomes, clinician competency, infusion safety, and educational gaps in intravenous and subcutaneous immunoglobulin therapy. Two posters presented by IgNS examined data from the 2025Patient 360 Longitudinal Survey, highlighting how structured education, adherence to best practices, and consistent monitoring can improve infusion safety and patient confidence in intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG) therapy. Across treatment settings, findings reinforced that national standards and evidence-based nursing and pharmacy practice, patient monitoring, education, and follow-up play a critical role in enhancing infusion quality and patient experience. In addition to supporting the data analysis and publication of the IgNS Patient 360 Survey results, GC Biopharma hosted a satellite breakfast symposium titled, "From Patient Voices to Clinical Choices: Bridging Perspectives in Primary Immunodeficiency." The program received overwhelmingly positive feedback, with 96 percent of respondents agreeing that the session met learning objectives and was presented clearly and effectively. Participants praised the inclusion of both patient and clinician perspectives, calling the session "very informative," "easily understandable," and "a fantastic presentation." "These initiatives underscore GC Biopharma's commitment to bring together patient voices and clinical insights to gain a more complete understanding of the obstacles and opportunities in immunoglobulin treatment," said Stacey Ness, PharmD, IgCP, CSP, MSCS, AAHIVP, Medical Affairs, GC Biopharma USA. "By supporting research like the IgNS Patient 360 data analysis and programs where patient experiences inform clinical decision making, we can help advance quality care and strengthen collaboration." As a company with more than 50 years of expertise in plasma protein manufacturing, GC Biopharma is committed to elevating standards in IVIG therapies. About ALYGLO® ALYGLO® (immune globulin intravenous, human-stwk) is a glycine-stabilized 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma from US donors. The manufacturing process includes multiple steps to reduce the risk of virus transmission. These include solvent/detergent treatment and 20 nm nanofiltration. The ALYGLO manufacturing process also uses G-XI™ Technology, its novel cation exchange (CEX) chromatography, that removes FXIa to undetectable levels.1,2 For more information about ALYGLO and G-XI™ Technology, visit . About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers lifesaving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is a leading global plasma protein and vaccine product manufacturer dedicated to quality healthcare solutions for over half a century. About GC Biopharma USA GC Biopharma USA, headquartered in Teaneck, NJ, is an operations and distribution company of GC Biopharma, that established its sales, marketing, and business operations in 2018 to serve customers and patients throughout the US. Our foundation is built on the expertise of our parent company GC Biopharma, a leading biopharmaceutical company delivering plasma therapies and vaccines worldwide for more than 50 years. With GC Biopharma USA, GC Biopharma further extends its footprint, bringing its expertise and legacy to the US. For more information, visit . INDICATION ALYGLO® is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. IMPORTANT SAFETY INFORMATION Contraindications: ALYGLO is contraindicated in patients who have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Hypersensitivity: In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. Epinephrine should be available for immediate treatment of severe acute hypersensitivity reactions. Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur. Aseptic Meningitis Syndrome (AMS): Aseptic meningitis syndrome (AMS) may occur, especially with high doses or rapid infusion. AMS usually begins within several hours to 2 days following ALYGLO treatment. Discontinuation of treatment has resulted in remission of AMS within several days without sequelae. Hemolysis: Delayed hemolytic anemia due to enhanced red blood cell (RBC) sequestration and acute hemolysis consistent with intravascular hemolysis have been reported. Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV. Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors. Transfusion-Related Acute Lung Injury: Noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) may occur. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Patients with TRALI may be managed using oxygen therapy with adequate ventilator support. Monitor patients for pulmonary adverse reactions. Transmissible Infectious Agents: Because ALYGLO is made from human blood, it may carry a risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent). Interference with Laboratory Tests: After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for a misleading interpretation. Adverse reactions (observed in ≥ 5% of study subjects) were headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle pain/aches, infusion site pain/swelling, abdominal pain/discomfort, cough, and dizziness. It is recommended that ALYGLO be administered separately from other drugs or medications. Please see Important Safety Information for ALYGLO on the preceding pages and refer to the full Prescribing Information (PI) or visit Alyglo.com. If you have an inquiry related to drug safety, or to report adverse events, please contact GC Biopharma USA at 1-833-426-6426 or email [email protected]. You can also visit FDA.gov/medwatch or call 1-800-FDA-1088. This press release may contain forward-looking statements that express the current beliefs and expectations of the management at GC Biopharma and GC Biopharma USA. Such views do not represent any guarantee by either entity or its government of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma and GC Biopharma USA undertake no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements they may make, except as required by law or stock exchange rule. References: 1. Kang GB, Huber A, Lee J, et al. Cation exchange chromatography removes FXIa from a 10% intravenous immunoglobulin preparation. Front Cardiovasc Med. 2023;10:1253177. 2. ALYGLO Prescribing Information. GC Biopharma; 2023. SOURCE GC Biopharma USA Inc. 21% more press release views with Request a Demo

Post Marketing Study to Evaluate the Role of CYTOGAM in the Reduction of Risk of Late CMV Disease Following the Conclusion of Standardly Prescribed Antiviral Treatment in High-Risk Kidney Transplant RecipientsREHOVOT, Israel, and HOBOKEN, N.J. , Nov. 04, 2025 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced that the first patient was enrolled into an investigator-initiated post-marketing clinical trial of CYTOGAM® (Cytomegalovirus Immune Globulin Intravenous [Human]) (CMV-IGIV) to prevent late Cytomegalovirus (“CMV”) infection, a common post-transplant infectious complication that remains an unaddressed medical need, despite recent advances in anti-viral drug therapies. The study, titled “Strategic Help with Immunoglobulin to Enhance protection against Late Disease (CMV)” or SHIELD, is a prospective, randomized, controlled multicenter investigator-initiated study in CMV high-risk kidney transplant recipients. CMV disease is an opportunistic infection that can occur in transplant recipients due to the use of anti-rejection medications that weaken the immune system. Anti-rejection medication is typically most intense in the first few months after transplant. During this period, transplant recipients are prescribed prophylactic antiviral medications. The SHIELD study will investigate the benefits of CYTOGAM administered at the conclusion of the anti-viral prophylaxis to reduce the risk of clinically significant late CMV in kidney transplant recipients who are CMV seronegative and have a CMV seropositive donor. These patients are at the highest risk of developing late-onset CMV infection, which is associated with worse transplant recipient health and outcomes. The study is being conducted by leading experts and key opinion leaders in CMV and organ transplantation, Camille Kotton, M.D., Infectious Disease Specialist and Clinical Director, Transplant and Immunocompromised Host Infectious Diseases at Massachusetts General Hospital, and David Wojciechowski D.O., Medical Director of the Kidney Transplantation Program at the University of Texas Southwestern Medical Center. Both investigators are recognized experts in transplant-related infections. Drs. Kotton and Wojciechowski said in a joint statement: “CMV disease is a leading cause for organ dysfunction and severe transplantation complications. There is a significant need in post-operative transplant care for rigorous scientific exploration of innovative prophylactic approaches for decreasing the risk of late CMV infection and improving transplant patient outcomes. We are grateful for Kamada’s support of this trial to explore the use of CYTOGAM dosed at the end of anti-viral prophylaxis therapy in patients with the highest risk of late CMV.” “Up to one third of kidney transplant patients may develop late CMV infection or disease after stopping initial anti-viral prophylaxis therapy,” said Amir London, Kamada’s Chief Executive Officer. “CYTOGAM is a critical life-saving therapeutic, and our support for this study further underscores Kamada’s commitment to serving the transplant community. We look forward to the results of this important post-marketing trial, led by two distinguished thought leaders in Drs. Kotton and Wojciechowski.” About CYTOGAMCytogam is an intravenous immunoglobulin containing standardized amount of antibody to cytomegalovirus. It is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart. In transplants of these organs other than kidney from CMV seropositive donors into seronegative recipients, prophylactic CMV-IGIV should be considered in combination with ganciclovir. Important Safety Information for CYTOGAM:Cytogam is contraindicated in individuals with a history of a prior severe reaction associated with the administration of this or other human immunoglobulin preparations. Persons with selective immunoglobulin A deficiency have the potential for developing antibodies to immunoglobulin A and could have anaphylactic reactions to subsequent administration of blood products that contain immunoglobulin A, including Cytogam. Minor reactions, such as flushing, chills, muscle cramps, back pain, fever, nausea, vomiting, arthralgia, and wheezing, were the most frequent adverse reactions observed during the clinical trials for Cytogam.  Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Thrombotic events have been reported in association with IGIV. Cytogam is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. Please see full Prescribing Information for full safety prescribing details.To report SUSPECTED ADVERSE REACTIONS, contact Kamada at pharmacovigilance@kamada.com or 1-(866)-916-0077 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About Kamada Kamada Ltd. (the “Company”) is a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived therapies field. The Company’s strategy is focused on driving profitable growth through four primary growth pillars: First, organic growth from its commercial activities, including continued investment in the commercialization and life cycle management of its proprietary products, which include six FDA-approved specialty plasma-derived products: KEDRAB®, CYTOGAM®, GLASSIA®, WINRHO SDF®, VARIZIG® and HEPAGAM B®, as well as KAMRAB®, KAMRHO (D)® and two types of equine-based anti-snake venom products, and the products in the distribution segment portfolio, mainly through the launch of several biosimilar products in Israel. Second: the Company aims to secure significant new business development, in-licensing, collaboration and/or merger and acquisition opportunities, which are anticipated to enhance the Company’s marketed products portfolio and leverage its financial strength and existing commercial infrastructure to drive long-term growth. Third: the Company is expanding its plasma collection operations to support revenue growth through the sale of normal source plasma to other plasma-derived manufacturers, and to support its increasing demand for hyper-immune plasma. The Company currently owns three operating plasma collection centers in the United States, in Beaumont Texas, Houston Texas, and San Antonio, Texas. Lastly, the Company is leveraging its manufacturing, research and development expertise to advance the development and commercialization of additional product candidates, targeting areas of significant unmet medical need, with the lead product candidate Inhaled AAT, for which the Company is continuing to progress the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. FIMI Opportunity Funds, the leading private equity firm in Israel, is the Company’s controlling shareholder, beneficially owning approximately 38% of the outstanding ordinary shares. CONTACTS:Chaime OrlevChief Financial OfficerIR@kamada.com Brian RitchieLifeSci Advisors, LLC212-915-2578britchie@LifeSciAdvisors.com