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lyophilized hepatitis-B human immunoglobulin

✓ Approved

Tonrol Bio-Pharmaceutical · Polyclonal Antibodies · Polyclonal Antibodies

What is lyophilized hepatitis-B human immunoglobulin?

lyophilized hepatitis-B human immunoglobulin is a polyclonal antibodies developed by Tonrol Bio-Pharmaceutical. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

CompanyTonrol Bio-Pharmaceutical
Drug ClassPolyclonal Antibodies, Vaccine, Antibody
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Tonrol Bio-Pharmaceutical

Therapeutic Indications

lyophilized hepatitis-B human immunoglobulin is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsHepatitis B✓ Approved

Related Research Articles

PubMedJournal of digestive diseases2026-10-15

Single Jaundice in Cirrhosis: A Neglected Acute Decompensation of Acute-on-Chronic Liver Failure and Mortality.

Zhang Xin X, Wang Xian Bo XB, Zheng Xin X, Tan Wen Ting WT et al.

To compare the risk of acute-on-chronic liver failure (ACLF) and short-term outcomes among cirrhotic patients with single jaundice, acute decompensation (AD) (including ascites, variceal bleeding, hepatic encephalopathy, and/or bacterial infection), and non-AD non-jaundice. We analyzed cirrhotic inpatients without obstructive jaundice enrolled from two large multicenter prospective cohorts. Patients were divided at admission into classical AD, single jaundice, or non-AD non-jaundice groups. Baseline characteristics, ACLF development, and short-term outcomes were compared between groups. Among 2645 cirrhotic patients, classical AD, single jaundice, and non-AD non-jaundice were observed in 2163 (81.78%), 267 (10.09%), and 215 (8.13%), respectively. The 90-day liver transplant (LT)-free mortality was comparable between single jaundice patients and classical AD patients (15.09% vs. 17.81%, p = 0.266), but significantly higher than non-AD non-jaundice patients (2.45%; p < 0.01). The prevalence of ACLF (16.10% vs. 16.09%, p = 1.000) and pre-ACLF (9.36% vs. 6.43%, p = 0.094) were comparable between the single jaundice and classical AD groups. Intrahepatic precipitants, particularly hepatitis B flare with hepatitis B virus (HBV) reactivation (odds ratio [OR] 2.69; p = 0.002), spontaneous hepatitis B flare with high HBV-DNA load (OR 23.75; p < 0.001), superimposed hepatitis A/E virus infection on HBV infection (OR 13.40; p < 0.001) and hepatotoxic drug usage (OR 3.64; p < 0.001) were associated with single jaundice. Cirrhotic inpatients with single jaundice show comparably high short-term mortality and ACLF risk to those with classical AD. Single jaundice shall be considered as an AD event and is predominantly triggered by intrahepatic insults, warranting surveillance equivalent to classical AD and prioritized management of the precipitants.

PMID 42876334
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PubMedFrontiers in medicine2026-10-15

Season-adjusted longitudinal changes in serum 25-hydroxyvitamin D during pegylated interferon add-on to ongoing tenofovir alafenamide therapy in chronic hepatitis B: a real-world cohort study.

Han Ning N, Liu Huan H, Zhu Xia X

To characterize serum 25-hydroxyvitamin D [25(OH)D] trajectories during peginterferon alfa-2b (Peg-IFN) add-on to ongoing tenofovir alafenamide (TAF) therapy in chronic hepatitis B and explore associations with hepatitis B surface antigen (HBsAg). This retrospective cohort identified 203 consecutive patients, of whom 190 contributed longitudinal data through week 48. The primary random-intercept mixed-effects model used categorical visit time and adjusted for seasonality, age, and sex. Continuous-time, random-slope, visit-timing, and HBsAg-censoring analyses assessed sensitivity. The primary adjusted week-48 25(OH)D difference was -7.9 nmol/L (95% CI, -9.8 to -6.0) (P < 0.001); the secondary continuous-time estimate was -8.3 nmol/L over 48 weeks. Observed concentrations declined through week 36 and partially rebounded at week 48. The proportion below 47.7 nmol/L increased from 21.1% to 34.7%. The adjusted total serum calcium trend was -0.061 mmol/L (95% CI, -0.074 to -0.049). Triglycerides increased while cholesterol fractions decreased. At week 48, 104/190 patients (54.7%) had an HBsAg decline of at least 1 log10 and 50/190 (26.3%) had visit-specific HBsAg loss. The concurrent 48-week change correlation was weak (ρ = 0.150; FDR-adjusted P = 0.117), and the magnitude of 25(OH)D decline was not independently associated with either binary endpoint. Within patients, each 10 nmol/L increase in 25(OH)D was associated with a 0.068-log10 IU/mL increase in concurrent HBsAg (95% CI, 0.020 to 0.116; P = 0.006). Serum 25(OH)D showed a non-linear decline during 48 weeks of follow-up, and the week-48 difference remained evident after adjustment for seasonality. However, without a concurrent comparator, the observed change cannot be attributed specifically to Peg-IFN, TAF, or their combination. Exploratory analyses suggested only a weak concurrent relationship between 25(OH)D and HBsAg, without evidence of prediction or causality. The clinical relevance of the observed changes in 25(OH)D and total serum calcium warrants further prospective investigation.

PMID 42876729
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PubMedJournal of viral hepatitis2026-10-15

Global Underutilization of Antiviral Therapy and Survival Outcomes in Hepatitis B Virus-Related Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis of 78 Studies and 68,243 Patients.

Kudaravalli Sahith S, Yan Taotao T, Tseng Cheng-Hao CH, Hsu Yao-Chun YC et al.

Antiviral therapy with nucleos(t)ide analogues is recommended for patients with viremic hepatitis B virus (HBV)-related cirrhosis regardless of levels of viremia or liver enzymes. However, hepatocellular carcinoma (HCC) is not an antiviral treatment criterion in the U.S. HBV treatment guidelines, though prior studies have reported improved survival with antiviral treatment in HBV-related HCC. To inform guidelines, we estimated antiviral treatment rates and their association with survival and HCC recurrence rates in HBV-related HCC. We conducted a systematic review and meta-analysis of studies published between 2006 and 2024 that reported antiviral treatment, survival, and/or HCC recurrence rates in adults with HBV-related HCC, following PRISMA guidelines. Random-effects models pooled study estimates. Of the initial 4556 studies, 178 underwent full-text review, and 78 (68,243 patients) were analysed. The pooled antiviral treatment rate (52 studies, 41,345 patients) was 53.1%. In studies reporting pre-HCC antiviral initiation, 17.2% of HBV-related HCC patients received therapy before diagnosis. Treated (vs untreated) patients had higher 3- and 5-year OS (80.4% vs. 59.2% and 72.1% vs. 46.8%, both p < 0.01). Five-year OS was 78.0% vs. 56.4% in inactive HCC (p < 0.01) and 48.2% vs. 22.6% in active HCC (p = 0.14). Antiviral therapy remained independently associated with improved 5-year OS in multivariable meta-regression. There was no significant difference in HCC recurrence rates. Antiviral therapy is associated with improved long-term survival but remains underutilized in HBV-related HCC. These findings highlight a critical gap in care and underscore the need for earlier and more consistent antiviral initiation in patients with HBV-related HCC.

PMID 42876044
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PubMedNature aging2026-10-15

Senescent-like activated naive B cells contribute to progression to clinical rheumatoid arthritis.

Wu Xiaohao X, Zhang Mengrui M, Moon Jae-Seung JS, Song Eun Kyung EK et al.

Rheumatoid arthritis (RA) is an autoimmune disease marked by joint and systemic inflammation. Anticitrullinated protein antibodies identify an at-risk stage that precedes clinical RA, yet the mechanisms driving disease progression remain poorly understood. Here we show that anticitrullinated-protein-antibody-positive individuals who progressed to RA exhibited a marked expansion of CXCR5+CD69+-activated naive B cells (aNAVs) before disease onset. These cells displayed inflammatory and senescent-like transcriptional programs and expressed polyreactive, autoreactive IgM B cell receptors. The expansion, activation and senescent-like phenotype of aNAVs were validated in multiple independent preclinical RA cohorts, and aNAVs were detectable in RA synovium. In vitro, aNAVs stimulated with citrullinated antigens promoted T cell activation in a human-leukocyte-antigen-dependent manner. Chronic exposure to citrullinated antigens and CpG (an innate immune stimulant) synergistically drove activation and senescent-like programming in naive B cells from individuals with RA. These findings identify senescent-like aNAVs as potential contributors and therapeutic targets for RA prevention.

PMID 42875583
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PubMedFrontiers in cardiovascular medicine2026-10-15

Pathogenicity assessment of a bicuspid aortic valve-associated ELASTIN variant using a zebrafish model.

Bernard Victor G VG, Théron Alexis A, Drouard Aurélien A, Avierinos Jean-François JF et al.

Bicuspid aortic valve (BAV) is one of the most common congenital heart defects but its genetic basis remains incompletely defined. Extracellular matrix components play key roles in outflow tract (OFT) and valve development, but their contribution to BAV is not fully established. Following the analysis of a cohort of BAV patients, we identified a family harbouring a rare human ELASTIN (ELN) variant (p.Gln691X). Here, we investigated the pathogenicity of this variant using an in vivo zebrafish model. We generated a zebrafish elna/b double knockout (KO) using an RNAless CRISPR Cas9 strategy to avoid genetic compensation. Cardiovascular morphology and function were assessed in mutant embryos. To evaluate pathogenicity of the human ELN p.Gln691X variant, mutant and control embryos were rescued by mRNA injection encoding either WT human ELN or the p.Gln691X variant. elna/b double KO zebrafish exhibited cardiovascular defects including OFT anomalies, reduced stroke volume and dysmorphic aortic valves, highlighting Elastin's critical role in cardiac development. We then used this model to test the ELN variant identified in the BAV family. We found that wild-type ELN mRNA was able to restore normal cardiac function and morphology, whereas the variant ELN mRNA failed to do so. Our study establishes a robust in vivo model to assess ELN variant pathogenicity and provides evidence linking ELASTIN to BAV, opening new avenues for uncovering the genetic mechanisms underlying BAV.

PMID 42876768
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PubMedAngewandte Chemie (International ed. in English)2026-10-15

Integrated Antigen-DNA Co-Detection Using Digital Microfluidics for Improving Diagnostic Accuracy in POCT Analysis.

Chai Fengli F, Li Fenggang F, Zhang Jiangjiang J, Li Zheng Z et al.

Simultaneous detection of protein and nucleic acid (NA) provides complementary information essential for accurate analysis of complex samples. Conventional approaches for the analysis of protein and NA typically rely on separate workflows and instruments, limiting the reliability of point-of-care testing. Here, we present a digital microfluidics-based dual-mode molecular assay for simultaneous detection of both protein and NA from the same microscale sample. The protein is captured by a gold nanoparticle-antibody conjugate, while NA is enriched by magnetic beads. Magnetic manipulation separates the protein-containing fraction from NA, enabling separate analysis of the two molecular classes within an automated workflow. By integrating the analysis of protein and NA, the platform enables more accurate analysis than either modality alone. In 56 clinical samples, the combined analysis of hepatitis B surface antigen and DNA reduces the false-negative rate to 1.79%, compared with 12.5% for HBsAg alone. In food safety assays, simultaneous detection of Staphylococcus aureus-associated toxins and PMA-treated bacterial NA provides information not only on protein-based toxins, but also the presence and viability of bacteria within milk. This automated DMF-based dual-mode molecular assay provides a highly integrated strategy for multimodal POCT and public health risk assessment.

PMID 42875884
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