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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

PubMedOpen forum infectious diseases2026-07-25

Prevalence of Hepatitis B Coinfection in People With HIV by Birth-Year Cohort.

Lee So Jeong SJ, Verinumbe Tarfa T, Lesko Catherine R CR, Fojo Anthony A et al.

Availability of the hepatitis B virus (HBV) vaccine in the United States since 1982 and recommendations for universal/catch-up vaccination of infants and children since the 1990s may be associated with lower HBV prevalence among people with human immunodeficiency virus (HIV; PWH) born after 1980. Active HBV infection prevalence, defined as the proportion of patients with a positive hepatitis B surface antigen result, was assessed among PWH at entry into a clinical cohort. Patients were categorized into birth-year cohorts of 1940-1959, 1960-1979, or 1980-1999 and then further dichotomized into pre- and post-1980 birth-year cohorts. Log binomial regression was used to assess the association of birth-year cohort with hepatitis B surface antigen positivity, adjusting for race/ethnicity, HIV infection risk factor, baseline HIV viral load and CD4+ cell count, HBV active therapy, and year of/age at cohort entry. Among 5598 PWH, most were male (67%) and Black (77%), with a mean age (SD) of 39.7 (9.6) years at cohort entry. Approximately a third of the participants (30%) identified as men who have sex with men, and 39% reported a history of injection drug use. At cohort entry, the majority had a CD4+ cell count <350/µL and a viral load >1000 copies/mL. The HBV prevalence was 6.7% overall but varied by birth-year cohort: 6.2% for 1940-1959, 7.9% for 1960-1979, and 2.6% for 1980-1999. The risk of HBV infection was lower in the post-1980 than in the pre-1980 cohort (adjusted prevalence ratio, 0.19 [95% confidence interval, .09- .42]). PWH born after 1980 had a lower prevalence of HBV coinfection than those born before 1980, supporting the potential impact of universal childhood HBV vaccination.

PMID 42500124
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PubMedArchives of virology2026-07-25

HBV PreS/S gene mutations in patients with chronic hepatitis B.

Çakal Bülent B, Çavuş Bilger B, Atasoy Alp A, Bulakçı Mesut M et al.

Variants in the hepatitis B virus (HBV) PreS/S gene have been suggested to contribute to the development of progressive liver disease. This study aimed to evaluate the association between HBV PreS/S variations and liver histopathology in patients with chronic hepatitis B. A total of 109 patients under clinical follow-up for chronic hepatitis B were included. The HBV PreS/S gene was amplified by PCR and sequenced using the Sanger method. Amino acid substitutions, nonsense mutations, and deletions were analyzed in relation to liver fibrosis stage. Overall, 58 of 389 amino acid sites (14.9%) in the HBV PreS/S gene showed substitutions, with the highest mutation rate observed in the PreS2 region (27.27%). Mutations L54P (PreS1), F130L/S (PreS2), and S207R/N/I/T and I208T (S gene) were significantly more frequent in patients with advanced fibrosis (F ≥ 3) (p < 0.05). Multivariable analysis identified S207R/N/I/T as an independent risk factor for liver fibrosis. Patients with PreS2 mutations had higher fibrosis scores (p < 0.05). The S207R/N/I/T mutation in the C-terminal region of the HBV S protein is independently associated with liver fibrosis, while PreS2 mutations may contribute to fibrosis progression in chronic hepatitis B.

PMID 42498832
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PubMedCureus2026-07-25

Fatal Acute Liver Failure Associated With Presumed Hepatitis B Virus Reactivation During Rituximab Maintenance Therapy: A Case Report.

Tran James J, Zhou Calvin C, Babun Asis A AA, Leung Whinkie W et al.

We report a woman in her 60s with follicular non-Hodgkin lymphoma receiving maintenance rituximab therapy, last administered one month prior to presentation, who developed progressive malaise, jaundice, and acute liver failure. Laboratory evaluation demonstrated severe hepatocellular injury with marked transaminase elevations (alanine aminotransferase: 2,500 U/L; aspartate aminotransferase: 2,400 U/L), hyperbilirubinemia (total bilirubin: 20 mg/dL), and coagulopathy. Hepatitis B virus (HBV) serology demonstrated active infection with elevated hepatitis B surface antigen (HBsAg) and detectable HBV DNA. Baseline HBV screening and antiviral prophylaxis records prior to rituximab initiation were unavailable from the treating institution, limiting the definitive confirmation of pre-existing HBV status. Given the patient's recent rituximab exposure, clinical presentation, and exclusion of alternative etiologies, HBV reactivation was considered the most likely diagnosis. The patient was diagnosed with HBV reactivation associated with rituximab therapy. Despite the initiation of antiviral treatment and aggressive supportive care, her clinical course rapidly deteriorated, complicated by hepatic encephalopathy, acute kidney injury requiring hemodialysis, and hypoxic respiratory failure. She was evaluated for liver transplantation but deemed ineligible due to multiorgan failure and ultimately transitioned to end-of-life care. This case highlights the potentially fatal consequences of HBV reactivation during rituximab therapy and underscores the importance of appropriate screening, prophylaxis, and vigilance in high-risk patients.

PMID 42500753
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PubMedArab journal of gastroenterology : the official publication of the Pan-Arab Association of Gastroenterology2026-07-25

Prevalence of HIV, HCV, HBV, and syphilis infection among Egyptian drug users: Cairo University hospitals' experience.

Cordie Ahmed A, Mohamed Rahma R, Enaba Dalia D, Mamdouh Rania R et al.

An integrated screening program with fast-track access to care for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), and Syphilis were implemented in substance use treatment clinic at Cairo University hospitals, Egypt. This study aimed to assess seroprevalence rates of HIV, HBV, HCV, and Syphilis among drug users and evaluate their awareness and uptake of prevention and testing services. A total of 2545 drug users were screened for HIV, HCV, Treponema pallidum (TP) antibodies, and surface antigen of HBV (HBsAg) between September 2022 and January 2024. Additionally, data on knowledge related to testing and prevention services were collected from 1066 drug users. Seroprevalence rates of HIV, HCV, HBsAg, and Syphilis were 4.4%, 8%, 1.34% and 0.1%, respectively. Among the 1066 drug users interviewed regarding their awareness and uptake of prevention and testing services, only 10 (1%) participants were tested for HCV during the previous nationwide screening campaign; three of them tested positive and two received treatment. Five (0.5%) participants were previously tested for HIV and were negative. Only 3 (0.3%) participants had heard of Pre-exposure prophylaxis (PrEP), while 5 (0.5%) received an HBV vaccination. No participants have ever received free condoms, clean needles or methadone maintenance therapy. Our findings indicate the need for improved testing, treatment, and prevention services directed to drug users, coupled with focused awareness efforts to increase access to these services.

PMID 42498558
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PubMedCureus2026-07-25

A Rare Case of Plasmablastic Myeloma With Dual Kappa and Lambda mRNA Expression Presenting as a Solitary Hard Palate Tumor.

Tanaka Ken K, Hasegawa Masaki M, Katsumi Akira A

Plasmablastic myeloma is an aggressive variant of plasma cell myeloma that can mimic plasmablastic lymphoma when it presents as a solitary mass. Dual kappa and lambda light-chain expression is exceptionally rare and may be missed if evaluation relies on protein-level detection alone. We report the case of a woman in her 80s who presented with left hard palate swelling and underwent resection of a solitary hard palate and maxillary tumor. Histology showed sheets of large plasmablastic cells positive for CD38, CD138, multiple myeloma oncogene 1, and immunoglobulin G, and negative for B-cell markers and Epstein-Barr virus-encoded RNA. Within weeks, she developed malaise, nausea, and pancytopenia. Laboratory studies revealed elevated lactate dehydrogenase and serum immunoglobulin G of 4,409 mg/dL with immunoparesis. Serum free light chains showed mildly elevated kappa and markedly elevated lambda, with a kappa/lambda ratio of 0.02. Positron emission tomography-computed tomography demonstrated diffuse skeletal and splenic fluorodeoxyglucose uptake without additional extramedullary lesions, confirming the hard palate tumor as the only extramedullary site. Bone marrow examination showed marked hypercellularity with extensive replacement by plasmablastic plasma cells expressing cyclin D1, while Epstein-Barr virus studies and anaplastic lymphoma kinase were negative. Light-chain immunohistochemistry showed absent kappa staining and lambda staining in only a small subset of tumor cells, whereas RNA in situ hybridization demonstrated dual light-chain messenger RNA expression in most tumor cells. Cytogenetic analysis revealed 1q21 amplification, deletion of 17p13, and immunoglobulin heavy chain/MAF rearrangement. Despite high-dose dexamethasone, sequential proteasome inhibitor-, anti-CD38 antibody-, and immunomodulatory drug-based therapies, followed by B-cell maturation antigen × CD3 bispecific antibody treatment, the disease remained refractory and the patient died 45 days after diagnosis. This case highlights that transcript-based light-chain testing can uncover exceptionally rare dual kappa and lambda expressions when protein assays are negative or misleading. In solitary plasmablastic lesions, integrated clinicopathological assessment, including cyclin D1, Epstein-Barr virus studies, and RNA in situ hybridization, is critical for accurate diagnosis and recognition of this highly aggressive subtype.

PMID 42500775
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PubMedNature reviews. Drug discovery2026-07-25

Targeting T follicular helper cells for lifelong health.

Linterman Michelle A MA, Yu Di D, Webb Louise M C LMC, Vinuesa Carola G CG

T follicular helper (TFH) cells support B cell function by promoting memory B cell differentiation and sustaining long-lasting antibody responses, thereby enabling immunity that protects the host from subsequent infections. TFH cells are essential for orchestrating the antibody-mediated immunity achieved via vaccination, which has had a profound global impact in reducing the morbidity and mortality associated with infectious diseases. TFH cells provide help to B cells both within and outside germinal centres and deliver key signals that drive immunoglobulin class switching and affinity maturation. The formation and function of TFH cells is dynamic and adaptable, with significant cellular plasticity to ensure that robust antibody production accompanies most immune responses. However, when antibodies are directed against self or non-pathogenic antigens, they can contribute to the development of autoimmune diseases, allergic reactions and transplant rejection. Beyond supporting antibody responses, TFH cells have been implicated in cancer, diabetes and atherosclerosis. Given the multifaceted roles of TFH cells in health and disease, and the changes to their biology during normal ageing, the development of targeted strategies to modulate TFH cell activity is an attractive approach to promote health across the lifespan.

PMID 42498736
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