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human hepatitis B immunoglobulin

✓ Approved

Hualan Biological Engineering Co., Ltd. · 多克隆抗体 · 多克隆抗体

什么是 human hepatitis B immunoglobulin？

human hepatitis B immunoglobulin 是一种多克隆抗体，由Hualan Biological Engineering Co., Ltd.研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intramuscular (IM) Injection。

药物档案

公司Hualan Biological Engineering Co., Ltd.
药物类别多克隆抗体, 抗体
给药途径Injectable (Others), Intramuscular (IM) Injection
状态Approved
来源： ClinicalTrials.gov, Hualan Biological Engineering Co., Ltd.

治疗适应症

human hepatitis B immunoglobulin 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Infections and infestationsHepatitis B✓ Approved

相关研究文献

PubMedVaccines2026-07-27

Advancing Global Hepatitis B Elimination: The Case for Using Maize as a Low-Cost, Heat-Stable, and Scalable Oral Vaccine.

Watanabe Muneaki M, Howard John A JA

Because hepatitis B virus (HBV) remains a major global health burden, innovative strategies are essential to achieve the World Health Organization's goal of eliminating viral hepatitis and closing persistent coverage gaps for injectable vaccines. While parenteral administration remains the gold standard for immunization, constraints such as cold-chain dependence and needle-associated barriers limit its reach, particularly in resource-constrained environments. This review summarizes work aimed at a plant-produced orally delivered vaccine as a transformative, scalable step towards global hepatitis B elimination. Early studies demonstrated proof of concept for the oral delivery of plant-produced hepatitis B vaccine candidates, including human trials using lettuce and potato as the host, but they were limited by low antigen yields and instability. In contrast, maize-produced antigens represent a significant advancement, achieving high levels of accumulation and utilizing the seed's natural desiccation physiology for bioencapsulation to protect the antigen from digestion in the gastrointestinal tract. Mechanistically, this platform enables timed antigen release in the duodenum, promoting M-cell uptake and CD103+ (cells expressing CD103 known as integrin alpha E) dendritic cell (DC) presentation, thus encouraging immunogenic programming over oral tolerance. In addition, defatting the grain by supercritical fluid extraction further improves antigen thermostability up to 45 °C for one month and ambient temperatures for one year, maintaining structural integrity under extreme conditions in accordance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) stability guidelines. Current recommendations for immunization are for three parenteral administrations using the hepatitis B surface antigen (HBsAg). The primary dose is usually given shortly after birth as a part of a multivalent vaccine. Therefore, initial studies for the oral plant-based vaccine have focused on using an oral boost after the parenteral prime. Data to support this premise are summarized along with co-administration of an oral and parental administration to elicit a stronger immune response. By overcoming past issues related to dose density and stability, this scalable, needle-free platform offers a practical way to eliminate global hepatitis B virus (HBV) transmission, especially in resource-constrained environments.

PMID 42506615
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PubMedVaccines2026-07-27

The Role of Human Viral Entry Receptor Mouse Models in Advancing Antiviral Antibodies and Vaccines.

Zuo Na N, Zheng Xin X, Ishaq Rameez R, Ren Deshan D et al.

Human viral entry receptor mouse models exist to overcome a fundamental experimental barrier: many clinically important viruses bind their human entry factors far more efficiently than the corresponding murine orthologs, leaving conventional mice unable to support authentic infection, physiological tissue tropism, or meaningful countermeasure evaluation. This review is organized around the receptor-humanization concept rather than around a single coronavirus model. Engineering strategies compared here include random transgenesis, endogenous-locus knock-in, minimal receptor-interface humanization, conditional and inducible expression, and transient vector-mediated delivery. Receptor systems covered span human angiotensin-converting enzyme 2 (hACE2)-dependent sarbecoviruses, human dipeptidyl peptidase 4 (hDPP4)-dependent Middle East respiratory syndrome coronavirus (MERS-CoV), human cluster of differentiation 4/human C-C chemokine receptor type 5 (hCD4/hCCR5)-dependentt human immunodeficiency virus type 1 (HIV-1), adenovirus receptor models, human intercellular adhesion molecule 1 (hICAM-1) rhinovirus systems, hepatitis C virus (HCV), hepatitis B virus (HBV), and hepatitis D virus (HDV) entry-factor models, measles receptor models, poliovirus receptor/CD155 (PVR/CD155) models, human scavenger receptor class B member 2 (hSCARB2) enterovirus systems, and human transferrin receptor 1 (hTfR1) arenavirus models. We then discuss how these platforms support antibody evaluation, Fc-effector analysis, vaccine protection, variant benchmarking, and safety assessment. These models yield the most reliable data when the experimental question is explicitly entry-dependent and when receptor expression level, anatomical distribution, pathology window, and immune context have all been independently validated. They are least informative when receptor expression is non-physiological, when disease readouts are driven by promoter artifacts, or when post-entry species barriers remain the dominant bottleneck. A validation-centered framework is therefore proposed to guide the selection of each model for the specific antiviral antibody or vaccine question it can legitimately answer.

PMID 42506651
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PubMedDiseases (Basel, Switzerland)2026-07-27

Impact of Gene Polymorphism rs2275913 and Serum IL-17A Levels on Liver Fibrosis Severity Across the Natural History of Chronic Hepatitis B in Indonesia.

Maimunah Ummi U, Palayukan Andrio A, Juniastuti, Tjokroprawiro Brahmana Askandar BA et al.

A complex interplay between viral activity and host immune responses drives the progression of liver fibrosis in chronic hepatitis B. The T helper 17 (Th17) immune pathway, which produces the pro-inflammatory cytokine interleukin-17A (IL-17A), has been implicated in hepatic fibrogenesis. However, the relationship between IL-17A levels, IL-17A G197A (rs2275913) gene SNP, and the degree of liver fibrosis across different phases of the natural history of chronic hepatitis B remains insufficiently explored. This study employed an analytical observational design with a cross-sectional approach in treatment-naïve patients with chronic hepatitis B. The degree of liver fibrosis was assessed using liver elastography. IL-17A (rs2275913) gene SNP was analysed using Real-Time PCR, while serum IL-17A levels were measured using enzyme-linked immunosorbent assay. Statistical analyses included Spearman's correlation, the contingency coefficient, the Chi-square test, the Kruskal-Wallis test, and the Mann-Whitney test, with a significance level set at p < 0.05. A total of 76 patients with chronic hepatitis B were included in this study. The phase of disease progression was significantly associated with the degree of liver fibrosis (p = 0.016). Median IL-17A levels increased in parallel with fibrosis severity (p = 0.003), with a particularly significant association observed during the R phase (p = 0.002). However, no significant association was found between the IL-17A G197A (rs2275913) gene SNP and either liver fibrosis severity or serum IL-17A levels. Elevated serum IL-17A levels were associated with greater liver fibrosis severity, particularly during the reactivation phase of chronic hepatitis B. These findings suggest a potential relationship between IL-17A-mediated immune responses and liver fibrosis in patients with chronic hepatitis B.

PMID 42505555
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PubMedZhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology2026-07-27

[APASL clinical practice guidelines on the management of chronic hepatitis B infection: a 2026 update].

You H H, Maiwall Rakhi R, Chen J J, Ahn H O O N HOON et al.

Globally, especially in the Asia-Pacific region, chronic hepatitis B infection has led to an undesirable escalating morbidity and mortality with acute-on chronic liver failure, end-staged liver cirrhosis and hepatocellular carcinoma. This has happened despite the past four-decades of major scientific advances made in screening methods, vaccination strategies, highly effective low-cost anti-viral therapies and surveillance strategies for early detection of hepatocellular carcinoma. To address this health threat, APASL has formed a Viral Elimination Taskforce to unite key opinion leaders from its member countries and regions. The ongoing shifts in hepatitis B epidemiology, socioeconomic changes, and advancements in technology are taken into consideration. With the conjoint efforts of all the members of the APASL Viral Elimination Taskforce, these clinical practice guidelines have been formulated aiming to facilitate healthcare professionals, policy makers and patients in making practical and cost-effective management decisions for chronic hepatitis B infection. Altogether, it provides recommendations in thirteen major areas related to screening, vaccination, treatment and HCC surveillance. The implementation of these clinical practice guidelines represents major APASL effort toward elimination of the disease burden due to chronic hepatitis B infection in Asia-Pacific region.

PMID 42503908
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PubMedZhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology2026-07-27

[Clinical significance and occurrence mechanism of hepatitis B virus DNA integration].

Shi Y J YJ, Zhang K X KX, Li M Y MY, Lu D J DJ et al.

Double-stranded linear DNA (dslDNA), considered to serve as a major precursor to integrated HBV DNA (iDNA), is generally located in the livers of patients with chronic HBV infection. Prior research has primarily focused on the role and mechanisms of HBV integration in the progression of hepatocellular carcinoma (HCC), demonstrating that iDNA can lead to genomic instability in the host and induce aberrant expression of host tumor-related genes around the integration sites, while viral proteins expressed by iDNA exhibit tumor-promoting effects. In recent years, the impact of iDNA-derived hepatitis B surface antigen on antiviral therapy in patients with chronic hepatitis B has received increasing attention with a deeper understanding of integrated HBV DNA. Consequently, the field has become a research hotspot and challenge in determining how to eliminate or silence iDNA to improve functional cure in patients with chronic hepatitis B. This paper aims to provide new sights to the clinical significance of iDNA and a theoretical basis for optimizing antiviral therapy strategies by summarizing the occurrence mechanisms of iDNA and its impact on the onset and progression of hepatocellular carcinoma and antiviral therapy for patients with chronic hepatitis B.

PMID 42503913
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PubMedVaccines2026-07-27

Evaluation of Hepatitis B Vaccine Immunogenicity in Low-Birth-Weight Infants After Complete Immunization: The Impact of Postnatal Catch-Up Growth and Maternal-Neonatal Characteristics.

Shen Lu L, Tang Wanqin W, Xie Yan Y, Hu Ran R et al.

Background: Low-birth-weight (LBW, <2500 g) infants are at increased risk of suboptimal hepatitis B vaccine responses; yet, data on their immunogenicity patterns and modifiable determinants remain limited. This study aimed to assess hepatitis B vaccine immunogenicity in LBW infants and to examine whether postnatal catch-up growth and maternal-neonatal characteristics are independently associated with antibody levels. Methods: We enrolled 511 LBW infants who completed the recommended 3-dose hepatitis B vaccination series at 0, 1, and 6 months. Blood samples were collected 4-6 weeks after completion of the full vaccination series. Geometric mean concentration (GMC) and seroprotection rate (SPR, anti-HBs ≥ 10 mIU/mL) were evaluated. Catch-up growth was quantified as the change in weight-for-age Z-score between 6 and 8 months of age (ΔWAZ). Multivariable linear regression was used to identify independent predictors of log-transformed antibody titers, adjusting for gestational age, maternal hepatitis B surface antigen (HBsAg) positivity, maternal body mass index (BMI), maternal fasting glucose, maternal thyroid disease, infant hemoglobin at 6 months, and ΔWAZ. Results: The overall SPR was 99.41% (508/511), with a GMC of 1045.37 mIU/mL (95% CI: 916.24-1192.70). SPR remained consistently high across all subgroups. In multivariable analysis, ΔWAZ was not significantly associated with antibody levels (β = -0.063, p = 0.571). Maternal HBsAg positivity showed no significant association (β = -0.104, p = 0.792). Maternal thyroid disease was independently associated with higher antibody levels (β = 0.793, 95% CI: 0.213-1.373, p = 0.007). None of the other covariates reached statistical significance. Conclusions: Hepatitis B vaccination demonstrated high immunogenicity in LBW infants, with very high seroprotection rates. Postnatal catch-up growth did not independently influence antibody levels. The significant positive association between maternal thyroid disease and infant antibody response warrants further prospective investigation.

PMID 42506603
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