An Open-Label, Single-Arm, Historically Controlled, Prospective, Multi-Center Phase III Study to Evaluate the Pharmacokinetics and Safety of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency

The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).

Start Date21 Dec 2020

Sponsor / Collaborator

GC Biopharma Corp.

[+1]

NCT03896932

/ CompletedNot ApplicableIIT

Study of Safety and Efficacy of Mini-pool Intravenous Immunoglobulin (MP-IVIG) Prepared by Assiut University Hospital Blood Bank in Primary Immunodeficiency Patients

1. study the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG)
2. Study the safety and efficacy of a newly developed preparation of MP-IVIG in children with primary immunodeficiency (PID) :
* Adverse reaction of MP-IVIG(anaphylaxis and haemolysis)( no or mild or moderate)
* Prevention of severe bacterial infection
* Improvement of general health(weight gain and mentality)
* Integration in to social live
3. Compare the efficacy of MP-IVIG to standard IVIG in children with primary immunodeficiency (PID).

Start Date01 Jan 2020

Sponsor / Collaborator

Assiut University

NCT03492710

/ WithdrawnPhase 3

Phase III Study of Immune Globulin Intravenous (Human) IGIV-SN in Pediatric Subjects With Primary Humoral Immunodeficiency

To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)

Start Date30 Apr 2019

Sponsor / Collaborator

Green Cross Co., Ltd.

100 Clinical Results associated with Immune globulin (GC Pharma)

100 Translational Medicine associated with Immune globulin (GC Pharma)

100 Patents (Medical) associated with Immune globulin (GC Pharma)

147

Literatures (Medical) associated with Immune globulin (GC Pharma)

01 Jan 2026·ANNALS OF THE RHEUMATIC DISEASES

Blocking the neonatal Fc receptor as a novel approach to prevent cardiac neonatal lupus: a proof-of-concept study

Article

Author: Clancy, Robert ; Carlucci, Philip M ; Cuneo, Bettina F ; Izmirly, Peter ; Masson, Mala ; Donofrio, Mary T ; Brandt, Justin S ; Fraser, Nicola ; Buyon, Jill P ; Worthing, Angus B ; Sachan, Nalani

OBJECTIVES:

Novel biologic agents targeting the neonatal Fc receptor (FcRn) offer a promising strategy to prevent cardiac neonatal lupus (cardiac-NL) in pregnant patients with high-titre anti-SSA/Ro52 kD or 60 kD autoantibodies via dual effects: reducing serum immunoglobin G (IgG) levels and inhibiting placental transfer. This study was initiated to assess the feasibility of FcRn blockade as prophylactic therapy for recurrent cardiac-NL.

METHODS:

A 34-year-old pregnant patient with systemic lupus erythematosus and 3 prior consecutive pregnancies complicated by neonatal lupus (1 cutaneous, 1 fatal cardiac-NL at 20 weeks, 1 cardiac-NL delivered at 32 weeks and neonatal cutaneous NL), each despite hydroxychloroquine 400 mg daily, was treated with weekly subcutaneous infusions of 560 mg rozanolixizumab (humanised IgG4 monoclonal antibody against FcRn) from gestational weeks 14 to 28 (to cover the vulnerable period of fetal cardiac injury) through a compassionate use designation. The patient performed home fetal heart rhythm monitoring thrice daily with weekly echocardiograms.

RESULTS:

Maternal anti-SSA/Ro52 kD and 60 kD autoantibodies, total IgG, and subclasses IgG1, 2, 3 decreased by about 65% at gestational week 22, with a return to near baseline levels by week 34. The pregnancy was uncomplicated, resulting in a spontaneous vaginal delivery of a healthy neonate at 37 weeks. At delivery, cord blood and maternal IgG levels were normal, obviating the need for rescue intravenous immune globulin. The neonate had a normal echocardiogram and electrocardiogram but developed a rash consistent with neonatal lupus at 5 weeks of life. There were no serious adverse events.

CONCLUSIONS:

The successful application of FcRn blockade to prevent recurrent cardiac-NL sets a precedent for a multicentre study.

01 Apr 2025·EUROPEAN JOURNAL OF NEUROLOGY

The Results of ADVANCE‐CIDP IVIG Trial: Intravenous Immunoglobulin 10% Therapy With GAMMAGARD LIQUID/Kiovig for Treatment of Relapse in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Article

Author: Greco, Erin ; Sivakumar, K. ; Wood, Jamie ; Levine, Todd ; Dori, Amir ; Duff, Kim ; Solano, Juan Marcos ; Anderson‐Smits, Colin ; Marchioni, Enrico ; Gamez, Josep ; Rejdak, Konrad ; Pasnoor, Mamatha ; Li, Zhaoyang ; Casasnovas, Carlos ; Corbo, Massimo ; Hasan, Shabbir ; Chroni, Elisabeth ; Bril, Vera ; Ay, Hakan ; Cocito, Dario ; Schmidt, Jens ; Siciliano, Gabriele ; Rivero, Alberto

ABSTRACT:

Background:

ADVANCE‐CIDP IVIG evaluated the efficacy and safety of immune globulin infusion (human) 10% solution (IVIG 10%; GAMMAGARD LIQUID, also known as Kiovig) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) as a rescue treatment for patients relapsing during the ADVANCE‐CIDP 1 trial.

Methods:

Open‐label ADVANCE‐CIDP IVIG included adult patients with confirmed CIDP relapse (≥ 1‐point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] disability scores from pre‐treatment baseline) during ADVANCE‐CIDP 1, which assessed the efficacy and safety of hyaluronidase‐facilitated subcutaneous immunoglobulin (fSCIG) 10%. Patients received an induction IVIG 10% dose (2 g/kg) followed by maintenance infusions at the same monthly equivalent dose of pre‐randomization IVIG, 3‐weekly for 6 months. The primary outcome was the responder rate (≥ 1‐point decrease in adjusted INCAT scores at treatment cessation vs. pre‐IVIG 10% baseline, in patients receiving placebo in ADVANCE‐CIDP 1). Other outcomes included the responder rate across all patients relapsing on fSCIG 10% or placebo in ADVANCE‐CIDP 1, time to functional improvement (≥ 1‐point decrease in adjusted INCAT score), and change in adjusted INCAT scores and Rasch‐built Overall Disability Scale (R‐ODS) centile scores from pre‐IVIG 10% baseline.

Results:

Overall, 20 patients received IVIG 10% (n = 4 [fSCIG 10%‐relapse group]; n = 16 [placebo‐relapse group]). Responder rate (95% confidence interval) was 100.0% (80.6%–100.0%) in the placebo‐relapse group and 95.0% (76.4%–99.1%) in the overall‐relapse population. Across all patients, median time to functional improvement was 25 days. At treatment cessation, mean changes from pre‐IVIG 10% baseline in adjusted INCAT and R‐ODS centile scores were −1.9 and 12.9, respectively.

Conclusions:

IVIG 10% effectively treated CIDP relapse and improved functional abilities.

01 Oct 2024·JOURNAL OF CLINICAL IMMUNOLOGY

Tolerability and Safety of Large-Volume Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% Administered with or without Dose Ramp-Up: A Phase 1 Study in Healthy Participants

Article

Author: Rondon, Juan Carlos ; Duff, Kim ; Yel, Leman ; Nagy, Andras ; Li, Zhaoyang ; Garcia, Enrique ; Lindner, Dirk ; Ay, Hakan

Abstract:

Purpose:

Facilitated subcutaneous immunoglobulin (fSCIG; immune globulin infusion 10% [human] with recombinant human hyaluronidase [rHuPH20]) permits high-volume subcutaneous immunoglobulin (SCIG) infusion, shorter infusion times and reduced dosing frequency relative to conventional SCIG. It is initiated by gradually increasing infusion volumes over time (dose ramp-up) to achieve target dose level (TDL). Whether ramp-up strategies have tolerability or safety advantages over direct initiation at full TDL has not been evaluated clinically.

Methods:

This phase 1 open-label study assessed tolerability and safety of fSCIG 10% with accelerated or no ramp-up compared with conventional ramp-up in healthy adults (NCT04578535). Participants were assigned to one of the three ramp-up arms to achieve TDLs of 0.4 or 1.0 g/kg/infusion. The primary endpoint was the proportion of infusions completed without interruption or infusion rate reduction owing to treatment-emergent adverse events (TEAEs). Safety was assessed as a secondary endpoint.

Results:

Of 51 participants enrolled, 50 (98.0%) tolerated all fSCIG 10% infusions initiated (n = 174). Infusion rate was reduced in one participant owing to headache in the 0.4 g/kg/infusion conventional ramp-up arm. Study discontinuations were higher in the no ramp-up arm (70%) versus the conventional (0%) and accelerated (22%) arms at the 1.0 g/kg/infusion TDL. Safety outcomes did not substantially differ between treatment arms.

Conclusion:

The favorable tolerability and safety profiles of fSCIG 10% in healthy participants support initiating treatment with fSCIG 10% with accelerated ramp-up at TDLs up to 1.0 g/kg. Data support no ramp-up at TDLs close to 0.4 g/kg but additional data are needed for higher doses.

News (Medical) associated with Immune globulin (GC Pharma)

11 May 2026

·www.biospace.com

GC Biopharma Presents New Data at CIS 2026 to Expand Analytical Understanding of IVIG Product Characteristics

Research explored molecular and physical characteristics of IVIG products that may help inform scientific understanding relevant to clinical care and product selection TEANECK, N.J.--(BUSINESS WIRE)--GC Biopharma USA, Inc., a leader in plasma-derived products, announced today the presentation of new data at the 2026 Clinical Immunology Society (CIS) Annual Meeting in New Orleans, Louisiana. GC Biopharma’s presentations at CIS included two company-authored posters, one on molecular size distribution of ALYGLO ® (immune globulin intravenous, human-stwk, 10% liquid) following mechanical stress and one on viscosity across intravenous immunoglobulin (IVIG) products. A third poster supported through GC Biopharma’s Investigator-Initiated Research Program includes an initial in silico evaluation of contaminant protein signatures and predicted immunogenicity-related differences across four commercially available IVIG products. “We’re proud to have supported research which was presented at a leading meeting in clinical immunology whose focus is to foster education, translational research, and novel approaches to patient care,” said Stacey Ness, PharmD, IgCP, CSP, MSCS, AAHIVP, Medical Science Liaison, Medical Affairs, GC Biopharma USA. “Together, our company-led research and supported external research contribute to broader scientific understanding of the molecular and physical characteristics of IVIG products. As immunoglobulin utilization continues to increase, these studies may help inform scientific evaluation, including considerations relevant to clinical care and product selection.” GC Biopharma presented two studies at CIS examining molecular and physical characteristics of IVIG products. The first presentation evaluated the impact of controlled mechanical agitation on the molecular size distribution of ALYGLO. The analysis described how molecular size distribution was assessed over time using size-exclusion high-performance liquid chromatography following agitation under defined laboratory conditions. The study concluded that mechanical agitation under the tested conditions had minimal impact on molecular size distribution, with a very high percentage of monomers and dimers remaining throughout the duration of the study, compared to polymers and fragments below quantifiable limits. The study also noted that further assessment under conditions more analogous to real-world settings is warranted. A second GC Biopharma study examined the viscosity of commercial IG preparations. All products showed consistent, sequential decreases in viscosity as temperatures increased, suggesting that room temperature (25° C) infusions could help mitigate viscosity-related risk. In addition, a study supported through GC Biopharma’s Investigator-Initiated Research Program described an in silico analytical approach to evaluating product-specific human contaminant protein signatures across commercial IVIG products. Using the ISPRI-HCP platform, the analysis compared contaminant protein burden and predicted immunogenicity-related characteristics across products. The authors concluded that in silico screening of contaminant protein signatures may help identify product-specific immunogenicity drivers and inform future IVIG product optimization. GC Biopharma also hosted a lunch symposium at CIS, titled “From Molecules to Tolerability: Understanding Immunoglobulins and Immunogenicity Through Advanced Molecular Characterization,” presented by Kevin Van Cott, Ph.D., Associate Professor in the Department of Chemical and Biomolecular Engineering at the University of Nebraska-Lincoln and Annie De Groot, M.D., Founder, EpiVax, Inc. and Founder and President of EVA Therapeutics. The speakers discussed how advanced protein characterization and immunogenicity assessment may broaden scientific understanding of intravenous immunoglobulin products and their attributes. As a company with more than 50 years of expertise in plasma protein manufacturing, GC Biopharma is committed to advancing scientific understanding of IVIG therapies and supporting research that may help inform patient care. 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 process, 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 WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE Thrombosis may occur with immune globulin intravenous (IGIV) products, including ALYGLO. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ALYGLO does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer ALYGLO 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: 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 (e.g., 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 medicalinfo@gcbiopharmausa.com . 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; 2025. Contacts media@gcbiopharmausa.com

VaccineImmunotherapyClinical Result

04 May 2026

·www.biospace.com

GC Biopharma Announces Lunch Symposium and Poster Presentations on IVIG Product Characterization at the 2026 CIS Annual Meeting

Presentations describe molecular size distribution of ALYGLO ® after mechanical stress, as well as cross-product analyses of viscosity and immunogenicity-related contaminant protein profiles TEANECK, N.J.--(BUSINESS WIRE)--GC Biopharma USA, Inc., a leader in plasma-derived products, announced today that it will host a lunch symposium and support three scientific presentations at the 2026 Clinical Immunology Society (CIS) Annual Meeting, taking place May 6 to 9 in New Orleans, Louisiana. GC Biopharma’s presentations at CIS will include two company-authored posters and one EpiVax-led poster supported through GC Biopharma’s Investigator-Initiated Research Program. GC Biopharma’s two posters will present research on molecular size distribution of ALYGLO ® (immune globulin intravenous, human-stwk, 10% liquid) following mechanical stress and on viscosity across IVIG products. The EpiVax-led poster will present an initial in silico evaluation of contaminant protein signatures and predicted immunogenicity-related differences across four commercially available IVIG products. “These presentations reflect GC Biopharma’s commitment to advancing scientific understanding of IVIG characterization through both company-led research and support for externally led studies that explore complementary product attributes,” said Stacey Ness, PharmD, IgCP, CSP, MSCS, AAHIVP, Medical Science Liaison, Medical Affairs, GC Biopharma USA. “Together, they represent several approaches to characterizing IVIG products with potential relevance to clinical practice.” GC Biopharma’s lunch symposium, titled “From Molecules to Tolerability: Understanding Immunoglobulins and Immunogenicity Through Advanced Molecular Characterization,” will take place on Friday, May 8, from 1:10 p.m. to 2:10 p.m. CT. The session will bring together expertise in advanced protein characterization and immunogenicity assessment to explore how analytical methods may deepen scientific understanding of immunoglobulin products. The speakers for this session will be: Kevin Van Cott, Ph.D., Associate Professor in the Department of Chemical and Biomolecular Engineering at the University of Nebraska-Lincoln, whose work focuses on advanced protein characterization and contaminant analysis in biopharmaceuticals, and Annie De Groot, M.D., Founder, EpiVax, Inc., and Founder and President of EVA Therapeutics , whose work has helped advance understanding of immunogenicity and in silico risk assessment. Poster presentations at CIS will include two studies conducted by GC Biopharma and one externally led study from EpiVax supported through GC Biopharma’s Investigator-Initiated Research Program: Title: Foundational Analysis of the Impact of Mechanical Stress on Molecular Size Distribution in Immune Globulin Intravenous, Human-stwk, 10% Presenter: Stacey Ness, PharmD, IgCP, CSP, MSCS, AAHIVP, Medical Affairs, GC Biopharma USA Day & Time: Thursday, May 7, 2026, 1:30 to 2:30 p.m. CT Title: Investigation Into the Viscosity of Commercial IG Preparations Presenter: Suzanne Strasters, MSN, FNP-C, IgCN, Medical Affairs, GC Biopharma USA Day & Time: Thursday, May 7, 2026, 1:30 to 2:30 p.m. CT Title: In Silico Hypersensitivity Risk Assessment of Product-Specific Human Contaminant Proteins in Commercial IVIG Products Presenter: Benjamin Gabriel, Ph.D., Research Scientist, EpiVax, Inc. Day & Time: Friday, May 8, 2026, 2:10 to 3:10 p.m. CT As a company with more than 50 years of expertise in plasma protein manufacturing, GC Biopharma is committed to advancing scientific understanding of IVIG therapies and supporting research that may help inform patient care. 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 process, 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 WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE Thrombosis may occur with immune globulin intravenous (IGIV) products, including ALYGLO. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ALYGLO does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer ALYGLO 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: 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 medicalinfo@gcbiopharmausa.com . 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; 2025. Contacts media@gcbiopharmausa.com

Vaccine

16 Apr 2026

·www.businesswire.com

GC Biopharma Announces Presentation on Aggregation Profiles of Commercial IVIG Products at NHIA 2026

TEANECK, N.J.--(BUSINESS WIRE)--GC Biopharma USA, Inc., a leader in plasma-derived products, today announced the presentation of new research evaluating the aggregation profiles, including molecular size distribution and particle size, in commercially available intravenous immunoglobulin (IVIG) products. The data will be presented at the 2026 National Home Infusion Association (NHIA) Annual Conference, taking place April 18–22, in Denver, Colorado. “As demand for immunoglobulin therapy continues to grow with improved disease recognition, analytical characterization of IVIG preparations helps advance scientific understanding of the molecular properties of these therapies,” said Alan Huber, PharmD. Global demand for IVIG has increased steadily due to improved recognition of primary immunodeficiencies and broader use in immune-mediated conditions. As utilization expands, manufacturing processes must balance immunoglobulin yield with product purity, stability, and safety. Protein aggregates are an important consideration in IVIG products, as they may influence immunogenicity, stability, and infusion-related reactions, highlighting the importance of monitoring impurities and aggregation during manufacturing. “Immunoglobulin therapy is the gold standard for the treatment of primary immunodeficiency and other immune-mediated conditions,” said Alan Huber, PharmD, Director of Medical Affairs at GC Biopharma USA. “As demand for immunoglobulin therapy continues to grow with improved disease recognition, analytical characterization of IVIG preparations helps advance scientific understanding of the molecular properties of these therapies.” In this analysis, ALYGLO® (immune globulin intravenous, human-stwk, 10% liquid) was evaluated alongside four other commercially available 10% IVIG products to characterize molecular size distribution and particle properties associated with protein aggregation. The data showed that the ALYGLO purification process resulted in an aggregation profile with a high percentage of monomers and dimers compared to low amounts of polymers and fragments. These findings contribute to the ongoing scientific evaluation of IVIG product characteristics and may help inform product selection strategies aimed at reducing immunogenicity associated with protein aggregates for patients receiving IVIG therapy. “These findings add to the ongoing characterization of IVIG preparations and provide additional analytical information on molecular size distribution and particle characteristics that may be relevant to IVIG preparation and administration,” said Stacey Ness, PharmD, IgCP, CSP, MSCS, AAHIVP, Medical Science Liaison, Medical Affairs, GC Biopharma USA. “As more patients receive IVIG therapy in home settings, GC Biopharma values the opportunity to engage with home infusion providers on the latest research and advances that support safe administration and high-quality patient care.” As a company with more than 50 years of expertise in plasma protein manufacturing, GC Biopharma is committed to elevating standards in IVIG therapies. To support control of plasma-derived impurities and protein aggregation, ALYGLO is produced using an enhanced purification process that includes cold ethanol fractionation, ultrafiltration/diafiltration, anion-exchange chromatography, solvent/detergent viral inactivation, cation-exchange chromatography, nanofiltration, and additional ultrafiltration steps prior to final formulation. The poster, “Assessment of the Aggregation Profile of Commercially Available Intravenous Immunoglobulin Products,” will be presented on Monday, April 20, 2026, from 1:00 p.m. to 2:30 p.m. in the NHIA Expo Hall. 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 process, that removes FXIa to undetectable levels.1,2 For more information about ALYGLO and G-XI™ Technology, visit www.alyglo.com. 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 www.gcbiopharma.us. 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 WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE Thrombosis may occur with immune globulin intravenous (IGIV) products, including ALYGLO. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ALYGLO does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer ALYGLO 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: 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 medicalinfo@gcbiopharmausa.com. 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; 2025.

VaccineImmunotherapyDrug Approval

100 Deals associated with Immune globulin (GC Pharma)

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Primary Immunodeficiency Diseases	United States	GC Biopharma Corp.	15 Dec 2023
Guillain-Barre Syndrome	South Korea	GC Corp.	18 Sep 2013
Mucocutaneous Lymph Node Syndrome	South Korea	GC Corp.	21 Aug 2013
Infectious Diseases	South Korea	GC Corp.	15 Aug 2013
Agammaglobulinemia	South Korea	GC Corp.	14 Aug 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Purpura, Thrombocytopenic, Idiopathic	Phase 3	South Korea	Green Cross Co., Ltd.	01 Jun 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FDA Manual	Not Applicable	Primary Immunodeficiency Diseases	33	ALYGLO	pksxqcogko(jckfksvmnq) = wmyfvzzuza vdyyjqpjud (pytihmgpru ) View more	Positive	15 Dec 2023
NCT02783482 (CTgov)	Phase 3	Primary Immunodeficiency Diseases	49	GC5107 (28-day Schedule)	smbiohmbec = iswfvbromc hoqksoflvv (zneddbirxy, bmcidyuegb - nmaqatbzax) View more	-	28 Oct 2022
NCT02783482 (CTgov)	Phase 3	Primary Immunodeficiency Diseases	49	GC5107 (21-day Schedule)	smbiohmbec = lzyirycnlm hoqksoflvv (zneddbirxy, txgitbrgzf - jsfksbywta) View more	-	28 Oct 2022
NCT02783482 (Pubmed \| Front Immunol) Manual	Phase 3	Primary Immunodeficiency Diseases	49	GC5107	gpsmgeyadn(mpvnwknjud) = acute serious bacterial infection nmmnfozlez (dewxnkcmbx )	Positive	08 Jul 2021
NCT02063789 (Pubmed \| Eur Spine J \| J Korean Med Sci) Manual	Phase 3	Purpura, Thrombocytopenic, Idiopathic	81	IVIg-SN	itufpymjgj(arnljqyycb) = haqewjtupf twvxjwzxtn (adjsyenebo, 8.40) View more	Positive	24 Apr 2018

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis