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).

开始日期2020-12-21

申办/合作机构

GC Biopharma Corp.

[+1]

NCT03896932

/ CompletedN/AIIT

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).

开始日期2020-01-01

申办/合作机构

Assiut University

NCT03492710

/ Withdrawn临床3期

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)

开始日期2019-04-30

申办/合作机构

Green Cross Co., Ltd.

100 项与 Immune globulin (GC Pharma) 相关的临床结果

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100 项与 Immune globulin (GC Pharma) 相关的转化医学

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100 项与 Immune globulin (GC Pharma) 相关的专利（医药）

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120

项与 Immune globulin (GC Pharma) 相关的文献（医药）

2023-11-01·Journal of clinical pharmacology

Dosing Strategy of Immunoglobulin (IgG) Replacement Therapies in Obese and Overweight Patients with Primary Immunodeficiency Diseases (PIDDs): A Meta‐Analysis of Clinical Trials

Article

作者: Zhou, Tingting ; Tegenge, Million A. ; Scott, John ; Golding, Basil

Abstract:

The current dosing strategy of immune globulin products for the treatment of primary immunodeficiency diseases (PIDDs) in the USA is based on total body weight (BW). The aim of our study was to assess the relationship between dose and trough level, and to determine whether an alternative dosing strategy should be considered for patients who are overweight or obese. We analyzed data in a total of 533 patients from 11 studies. We modeled the relationship between trough level and dose per week using a linear mixed model. We used an over‐dispersed Poisson model to model the relationship between infection and trough level. In these analyses, we then combined the study‐specific treatment effects using a random‐effect or fixed‐effect model. The mean administered dose per week was 9.77, 14.00, or 18.17 g in patients who were normal weight, overweight, or obese, respectively. Compared with a patient of normal weight, a 1 g increase in dose per week in a patient who was overweight was associated with a smaller increase in the trough level, 0.08 g/L less (95%CI –0.14 to –0.03 g/L), and a 1 g increase in dose per week in a patient who was obese was associated with a much smaller increase in trough level, 0.01 g/L less (95% CI –0.07 to 0.06 g/L). Last, for a 1 unit (g/L) increase in trough level, the expected number of infections remained the same, with a multiplicative factor of 1.01 (95%CI 0.98‐1.04). Overall, we found no compelling evidence to justify a reconsideration of the current dosing strategy based on total BW for patients with PIDDs who are overweight or obese.

2023-08-01·Hospital pharmacy

Use of Intravenous Anakinra for Management of Pediatric Cytokine Storm Syndromes at an Academic Medical Center

Article

作者: Heath, Travis ; Lowry, Sandra ; Yang, Lirong

Background: Off-label intravenous (IV) route of anakinra is increasingly recognized to enable higher and faster maximal plasma concentrations than subcutaneous route for treatment of cytokine storm syndromes. Objective: To describe off-label indications of IV anakinra, corresponding dosing and safety profiles, particularly during the coronavirus disease 19 (COVID-19) pandemic. Methods: A retrospective, single-cohort study was conducted at an academic medical center to evaluate use of IV anakinra in hospitalized pediatric patients (age ≤21 years). Institutional Review Board review was considered exempt. The primary endpoint was the primary indication(s) for IV anakinra. The key secondary endpoints were dosing of IV anakinra, previous immunomodulatory therapies, and adverse events. Results: Of 14 pediatric patients, 8 (57.1%) received IV anakinra for treatment of multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19, whereas 3 and 2 were treated for hemophagocytic lymphohistiocytosis (HLH) and flares of systemic onset juvenile idiopathic arthritis (SoJIA), respectively. The initial dosing regimen of IV anakinra for MIS-C associated with COVID-19 was a median dose of 2.25 mg/kg/dose with a median dosing interval of 12 hours for a median initial treatment duration of 3.5 days. Eleven (78.6%) patients received previous immunomodulatory therapies (IV immune globulin [n = 10; 71.4%] and steroids [n = 9; 64.3%]). No adverse drug events were documented. Conclusion: IV anakinra was used off-label for treatment of MIS-C associated with COVID-19, HLH and SoJIA flares in critically ill patients with no adverse drug events documented. This study helped ascertain the off-label indications of IV anakinra and corresponding patient characteristics.

2023-02-17·Medicine

Gene mutations in the PI3K/Akt signaling pathway were related to immune thrombocytopenia pathogenesis

Article

作者: Hui-Ting Qu ; Jing-Shu Ruan ; Rui-Jie Sun ; Xiao-Hui Sui ; Dai Yuan ; Ning-Ning Shan ; Jin-Ping Wang

Background::

Immune thrombocytopenic (ITP) is an autoimmune bleeding disease with genetic susceptibility. Twenty newly diagnosed active primary ITP patients who had not been treated with glucocorticosteroids, immune globulin or immunosuppressants prior to sampling were enrolled in this study. Bone marrow blood mononuclear cells were used for whole exome sequencing to further elucidation the variant genes of ITP.

Methods::

High-molecular-weight genomic DNA was extracted from freshly frozen bone marrow blood mononuclear cells from 20 active ITP patients. Next, the samples were subjected to molecular genetic analysis by whole-exome sequencing, and the results were confirmed by Sanger sequencing. The signaling pathways and cellular processes associated with the mutated genes were identified with gene ontology and Kyoto Encyclopedia of Genes and Genomes pathway analyses.

Results::

The results showed that there were 3998 missense mutations involving 2269 genes in more than 10 individuals. Unique genetic variants including phosphatase and tensin homolog, insulin receptor, and coagulation factor C homology were the most associated with the pathogenesis of ITP. Functional analysis revealed these mutation genes mainly affect Phosphatidylinositol 3 kinase/serine/threonine kinase B signaling pathways (signal transduction) and platelet activation (immune system).

Conclusion::

Our finding further demonstrates the functional connections between these variant genes and ITP. Although the substantial mechanism and the impact of genetic variation are required further investigation, the application of next generation sequencing in ITP in this paper is a valuable method to reveal the genetic susceptibility.

项与 Immune globulin (GC Pharma) 相关的新闻（医药）

2025-12-23

·PRNewswire

GC Biopharma Secures IND Approval for Phase 1 Clinical Trial of COVID-19 mRNA Vaccine in Korea

- Phase 2 IND submission targeted for the second half of 2026 - Demonstrating the competitiveness of GC Biopharma's mRNA platform YONGIN, South Korea, Dec. 22, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a leading global biopharmaceutical company, announced today that Ministry of Food and Drug Safety (MFDS) in South Korea has approved the Investigational New Drug (IND) application for the Phase 1 clinical trial of "GC4006A", mRNA (messenger RNA) vaccine candidate for COVID-19. Following the IND submission in September, the approval was granted in a short timeframe. The company expects to accelerate development in alignment with the Korean government's policy initiative to localize mRNA vaccine. GC Biopharma plans to submit Phase 2 IND in the second half of 2026. GC4006A is a COVID-19 vaccine candidate developed using GC Biopharma's proprietary mRNA-LNP (Lipid Nanoparticle) platform. mRNA vaccines are regarded as a critical technology that extends beyond a single infectious disease, as they enable rapid responses to emerging pathogens and viral variants in future pandemics. Meanwhile, GC Biopharma was recently selected as a recipient of Phase 1 clinical research support under the Korea Disease Control and Prevention Agency (KDCA)'s 'mRNA Vaccine Development Support Project for Pandemic Preparedness'. "This IND approval represents a meaningful milestone, demonstrating the robustness and competitiveness of our mRNA platform", said Jaewoo Lee, Head of the Regulatory Science & Product Development Division at GC Biopharma. "We will continue to explore the applicability of the platform technology across various therapeutic areas, including vaccines." GC Biopharma's mRNA-LNP platform enhances both the level and durability of protein expression by applying its proprietary UTR1) patents, codon2) optimization technology, and LNP with advanced delivery efficiency. GC Biopharma is the first company in Korea to independently execute the entire process of mRNA vaccines from candidate discovery to manufacturing and production. --- 1) Untranslated Region, Regions positioned before and after the codon that play a role in controlling mRNA stability and protein expression 2) The portion of mRNA to produce proteins About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo® (intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. GC Biopharma Contacts (Media) Sohee Kim [email protected] Yelin Jun [email protected] Yoonjae Na [email protected] SOURCE GC Biopharma 21% more press release views with Request a Demo

疫苗临床申请信使RNA临床1期

2025-12-09

·动脉网

GC生物制药公司运送了世界上第一种重组炭疽疫苗“BARYTHRAX inj.”的首批剂量GC Biopharma Ships First Doses of World's First Recombinant Anthrax Vaccine, 'BARYTHRAX inj.'

GC Biopharma (006280.KS), a leading global biopharmaceutical company, today announced the first shipment of BARYTHRAX inj., the world's first recombinant anthrax vaccine. The product, jointly developed by the Korea Disease Control and Prevention Agency (KDCA) and GC Biopharma, was granted regulatory approval in April as Korea's 39th locally developed new drug.. GC Biopharma（006280.KS），一家全球领先的生物制药公司，今天宣布了世界上首个重组炭疽疫苗BARYTHRAX inj.的首次发货。该产品由韩国疾病控制与预防中心（KDCA）和GC Biopharma共同开发，于今年四月获得监管批准，成为韩国第39种本土研发的新药。The initial supply will be delivered to the KDCA for national stockpiling, supporting public health preparedness against biological threats, including potential bioterrorism. 初始供应将交付给韩国疾病控制与预防中心（KDCA），用于国家战略储备，以支持针对包括潜在生物恐怖主义在内的生物威胁的公共卫生防范工作。BARYTHRAX inj. is the first anthrax vaccine globally to be developed using recombinant protein technology. Unlike conventional vaccines that use live attenuated or avirulent strain of Bacillus anthracis, BARYTHRAX inj. is based solely on the purified Protective Antigen (PA) protein, a principal component of the anthrax toxin.. BARYTHRAX注射剂是全球首个采用重组蛋白技术开发的炭疽疫苗。与使用减毒或无毒炭疽芽孢杆菌株的传统疫苗不同，BARYTHRAX注射剂仅基于纯化的保护性抗原（PA）蛋白，这是炭疽毒素的主要成分。Clinical studies showed that BARYTHRAX inj. induces neutralizing antibodies that meet the predefined immunogenicity thresholds. This result supports its potential to effectively protect individuals in the event of anthrax exposure. 临床研究表明，BARYTHRAX注射剂能够诱导达到预定义免疫原性阈值的中和抗体。这一结果支持了它在炭疽暴露情况下有效保护个体的潜力。Furthermore, the safety assessment confirmed that the primary adverse events reported in the BARYTHRAX inj. group —such as injection-site pain, myalgia, and fatigue —were generally mild and temporary. No acute adverse reactions or deaths occurred, proving the vaccine's strong safety profile. 此外，安全性评估确认，BARYTHRAX注射组报告的主要不良事件（如注射部位疼痛、肌肉痛和疲劳）通常为轻度且短暂。未发生急性不良反应或死亡事件，证明了该疫苗良好的安全性。Manufacturing is carried out at GC Biopharma's advanced Hwasun facility in Korea, which can produce up to 10 million doses annually sufficient to immunize approximately 2.5 million people based on a four-dose regimen. The vaccine is also designed for rapid, scalable production in emergency scenarios.. 制造是在韩国GC Biopharma先进的和顺工厂进行的，该工厂每年可生产多达1000万剂疫苗，按照四剂方案足以免疫大约250万人。该疫苗还设计用于在紧急情况下快速、可扩展的生产。'Delivering the world's first recombinant anthrax vaccine marks a significant step forward in national biosecurity,' said Eun-Chul Huh, CEO of GC Biopharma. 'We remain committed to supporting national biodefense and advancing vaccine security through innovation and strategic partnerships.' “交付世界上首个重组炭疽疫苗标志着国家生物安全向前迈出了重要一步，”GC Biopharma首席执行官Eun-Chul Huh表示。“我们仍然致力于通过创新和战略合作伙伴关系来支持国家生物防御并提升疫苗安全性。”About GC Biopharma 关于GC BiopharmaGC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo® (intravenous immunoglobulin G) in 2024. GC Biopharma（前身为Green Cross Corporation）是一家总部位于韩国龙仁的生物制药公司。该公司在血浆衍生物和疫苗的开发与生产方面拥有超过半个世纪的经验，并通过2024年成功进入美国市场的Alyglo®（静脉注射免疫球蛋白G）扩展其全球影响力。In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). 为了满足未来医疗保健需求的使命，GC Biopharma继续通过其在蛋白质、mRNA和脂质纳米颗粒（LNP）药物递送平台工程方面的核心研发能力推动创新，开发罕见病以及免疫学与炎症（I&I）领域的治疗药物。To learn more about the company, visit https://www.gcbiopharma.com/eng/. 要了解更多关于该公司的信息，请访问 https://www.gcbiopharma.com/eng/。This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. 本新闻稿中的前瞻性声明可能包含生物制药内容，表达GC Biopharma管理层当前的信念和期望。此类声明不代表GC Biopharma或其管理层对未来的业绩做出任何保证，并且涉及已知和未知的风险、不确定性及其他因素。GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule.. GC Biopharma 不承担更新或修改本新闻稿中包含的任何前瞻性声明或其可能作出的任何其他前瞻性声明的义务，除非法律或证券交易所规则要求。GC Biopharma Contacts (Media) GC生物制药联系人（媒体）Sohee Kim 金素熙shkim20@gccorp.com shkim20@gccorp.comYelin Jun 岳麟俊yelin@gccorp.com 叶林@gccorp.comYoonjae Na 罗允载yjy6520@gccorp.com yjy6520@gccorp.comSource:prnewswire.com 来源：prnewswire.com

2025-12-08

·PRNewswire

GC Biopharma Ships First Doses of World's First Recombinant Anthrax Vaccine, 'BARYTHRAX inj.'

- First anthrax vaccine developed using recombinant DNA technology - Annual production capacity of up to 10 million doses at GC Biopharma's facility YONGIN, South Korea, Dec. 8, 2025 /PRNewswire/ -- GC Biopharma (006280.KS), a leading global biopharmaceutical company, today announced the first shipment of BARYTHRAX inj., the world's first recombinant anthrax vaccine. The product, jointly developed by the Korea Disease Control and Prevention Agency (KDCA) and GC Biopharma, was granted regulatory approval in April as Korea's 39th locally developed new drug. The initial supply will be delivered to the KDCA for national stockpiling, supporting public health preparedness against biological threats, including potential bioterrorism. BARYTHRAX inj. is the first anthrax vaccine globally to be developed using recombinant protein technology. Unlike conventional vaccines that use live attenuated or avirulent strain of Bacillus anthracis, BARYTHRAX inj. is based solely on the purified Protective Antigen (PA) protein, a principal component of the anthrax toxin. Clinical studies showed that BARYTHRAX inj. induces neutralizing antibodies that meet the predefined immunogenicity thresholds. This result supports its potential to effectively protect individuals in the event of anthrax exposure. Furthermore, the safety assessment confirmed that the primary adverse events reported in the BARYTHRAX inj. group —such as injection-site pain, myalgia, and fatigue —were generally mild and temporary. No acute adverse reactions or deaths occurred, proving the vaccine's strong safety profile. Manufacturing is carried out at GC Biopharma's advanced Hwasun facility in Korea, which can produce up to 10 million doses annually sufficient to immunize approximately 2.5 million people based on a four-dose regimen. The vaccine is also designed for rapid, scalable production in emergency scenarios. "Delivering the world's first recombinant anthrax vaccine marks a significant step forward in national biosecurity," said Eun-Chul Huh, CEO of GC Biopharma. "We remain committed to supporting national biodefense and advancing vaccine security through innovation and strategic partnerships." About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company headquartered in Yong-in, South Korea. The company has over half a century of experience in the development and manufacturing of plasma derivatives and vaccines, and is expanding its global presence with successful US market entry of Alyglo® (intravenous immunoglobulin G) in 2024. In line with its mission to meet the demands of future healthcare, GC Biopharma continues to drive innovation by leveraging its core R&D capabilities in engineering of proteins, mRNAs, and lipid nanoparticle (LNP) drug delivery platform to develop therapeutics for the field of rare disease as well as I&I (Immunology & Inflammation). To learn more about the company, visit This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma's management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. GC Biopharma Contacts (Media) Sohee Kim [email protected] Yelin Jun [email protected] Yoonjae Na [email protected] SOURCE GC Biopharma 21% more press release views with Request a Demo

疫苗上市批准

100 项与 Immune globulin (GC Pharma) 相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
原发性免疫缺陷疾病	美国	GC Biopharma Corp.	2023-12-15
格林-巴利综合征	韩国	Green Cross Holdings Corp.	2013-09-18
粘膜皮肤淋巴结综合征	韩国	Green Cross Holdings Corp.	2013-08-21
感染	韩国	Green Cross Holdings Corp.	2013-08-15
丙种球蛋白缺乏血症	韩国	Green Cross Holdings Corp.	2013-08-14

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
原发性T细胞免疫缺陷	申请上市	美国	Green Cross Holdings Corp.	2015-11-08
免疫性血小板减少症	临床3期	韩国	Green Cross Co., Ltd.	2014-06-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


FDA 人工标引	N/A	原发性免疫缺陷疾病	33	ALYGLO	廠夢觸簾憲夢憲蓋鏇蓋(鹹蓋繭鏇膚顧簾襯艱簾) = 遞糧窪選窪鹹築衊願壓糧積膚構糧網壓膚襯糧 (鏇積選遞鑰淵遞選鹽積 ) 更多	积极	2023-12-15
NCT02783482 (CTgov)	临床3期	原发性免疫缺陷疾病	49	GC5107 (28-day Schedule)	膚範顧範膚蓋壓窪構積 = 糧壓構襯範鹹襯繭餘構網觸繭衊蓋鑰廠積構鬱 (範網鹽觸膚選遞窪夢艱, 遞構鏇窪顧窪齋範簾窪 ~ 獵窪願鑰艱鹽簾淵範夢) 更多	-	2022-10-28
NCT02783482 (CTgov)	临床3期	原发性免疫缺陷疾病	49	GC5107 (21-day Schedule)	膚範顧範膚蓋壓窪構積 = 願醖餘製糧餘壓積顧獵網觸繭衊蓋鑰廠積構鬱 (範網鹽觸膚選遞窪夢艱, 壓蓋範範醖鏇憲網願憲 ~ 襯網遞廠醖廠廠簾蓋廠) 更多	-	2022-10-28
NCT02783482 (Pubmed \| Front Immunol) 人工标引	临床3期	原发性免疫缺陷疾病	49	GC5107	鏇艱築艱鹹襯鬱糧廠夢(淵鏇遞夢壓鏇構網膚構) = acute serious bacterial infection 範憲鬱夢鑰淵膚憲築網 (鏇簾廠鹽願繭網淵簾鏇 )	积极	2021-07-08
NCT02063789 (Pubmed \| Eur Spine J \| J Korean Med Sci) 人工标引	临床3期	免疫性血小板减少症	81	IVIg-SN	艱壓蓋顧蓋鑰鏇夢網淵(醖願構願淵構鑰選憲繭) = 襯蓋鏇鏇蓋製夢鏇範積夢簾製築齋積獵鑰顧積 (窪鬱艱顧選鏇遞廠顧廠, 8.40) 更多	积极	2018-04-24