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anti-hepatitis-B therapy (IMMUNO HBS / UMANBIG / IMMUNOHBS)

✓ Approved

Kedrion · Polyclonal Antibodies · Polyclonal Antibodies

What is anti-hepatitis-B therapy?

anti-hepatitis-B therapy is a polyclonal antibodies developed by Kedrion. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection or intravenous (iv).

Drug Profile

Brand NamesIMMUNO HBS, UMANBIG, IMMUNOHBS
CompanyKedrion
Drug ClassPolyclonal Antibodies, Antibody
RouteInjectable (Others), Intramuscular (IM) Injection, Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Kedrion

Therapeutic Indications

anti-hepatitis-B therapy is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsHepatitis B✓ Approved

Related Research Articles

PubMedExperimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation2026-10-16

Hepatitis B Virus Recurrence After Liver Transplant for Hepatitis B Virus-Related Liver Disease: A Retrospective Analysis of Hepatitis B Immunoglobulin Discontinuation.

Aktuna Hakan H, Daniş Nilay N, Döngelli Hüseyin H, Bacakoğlu Aylin A et al.

Hepatitis B virus recurrence after liver transplant remains a clinically relevant issue, but the optimal duration and safety of hepatitis B immunoglobulin therapy, particularly its discontinuation, remain unclear. Here, we evaluated the incidence and risk factors of posttransplant hepatitis B virus recurrence and assessed outcomes following elective discontinuation of hepatitis B immunoglobulin in a real-world cohort. We conducted a retrospective single-center cohort study of consecutive adult patients who underwent liver transplant for hepatitis B virus-related liver disease between 1997 and 2023. Hepatitis B virus recurrence was defined as the reappearance of hepatitis B surface antigen and/or detectable hepatitis B virus DNA. We used Cox proportional hazards models to identify factors associated with recurrence and overall survival. We conducted a predefined subgroup analysis to evaluate patients who underwent elective discontinuation of hepatitis B immunoglobulin during antiviral therapy. Among 254 liver transplant recipients, 39 (15.4% ) developed posttransplant hepatitis B virus recurrence. In multivariable analysis, pretransplant hepatitis B virus DNA levels >5 log10 copies/mL (hazard ratio 3.68; 95% CI, 1.82-7.46) and hepato-cellular carcinoma at transplant (hazard ratio 2.38; 95% CI, 1.22-4.65) were independently associated with recurrence, whereas hepatitis D virus coinfection was inversely associated (hazard ratio 0.18; 95% CI, 0.08-0.43). Elective hepatitis B immunoglobulin discontinuation was not associated with increased hepatitis B virus recurrence and was primarily performed in clinically selected low-risk patients. Posttransplant hepatitis B virus recurrence was associated with reduced overall survival. In this long-term, real-world cohort, posttransplant hepatitis B virus recurrence was mainly driven by the pretransplant viral burden and oncological factors. Elective hepatitis B immunoglobulin discontinuation in carefully selected patients was not associated with increased recurrence, likely reflecting the underlying risk stratification rather than a causal protective effect. These findings support the use of individualized risk-based hepatitis B immunoglobulin strategies after liver transplant.

PMID 42885707
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PubMedJournal of neurology2026-10-16

Antiviral and inflammatory immune signatures in anti-CD20-treated multiple sclerosis: a cross-sectional study.

D'Orso Silvia S, Picozza Mario M, Guerrera Gisella G, Verdiani Alice A et al.

CD20-targeting monoclonal antibodies are highly effective therapies for relapsing multiple sclerosis (MS). We examined how anti-CD20 therapy reshapes antiviral T-cell immunity, innate inflammatory tone, and blood markers of neuroaxonal injury. In this cross-sectional study, adults with relapsing MS were enrolled at two neurological centers in Rome. An immunophenotyping cohort (45 untreated, 25 anti-CD20-treated, all receiving ocrelizumab) was profiled by high-parameter flow cytometry across more than 40 immune populations. A separate antiviral cohort (24 untreated, 13 treated, 19 healthy donors) was assessed for T-cell responses to Epstein-Barr virus (EBV), cytomegalovirus (CMV) and SARS-CoV-2 by activation-induced marker assay, for cytokine and chemokine release by multiplex assay, and for serum neurofilament light chain (sNfL) by single-molecule array. Groups were compared by Kruskal-Wallis with Dunn's correction; correlations used Spearman's rank test. Anti-CD20 therapy depleted total and switched-memory B cells while sparing antibody-secreting cells and reduced absolute counts of follicular helper T cells and mucosal-associated invariant T cells. Untreated patients with MS (pwMS) showed elevated monocyte interleukin-1β and monocyte chemotactic protein-3 (MCP-3) and impaired pDC cell interferon-α production, whereas pDC IFN-α responses in ocrelizumab-treated pwMS were comparable to those in HD. EBV-specific CD4+ T-cell counts and stimulation index were selectively lower ocrelizumab-treated pwMS, whereas CMV- and SARS-CoV-2-specific responses were comparable across groups. sNfL was elevated in untreated pwMS and correlated with MCP-3 at baseline and after EBV stimulation. Anti-CD20 therapy acts on immune circuits beyond B cells, selectively contracting EBV-directed helper T-cell immunity while sparing other antiviral responses, and identifies MCP-3 as a candidate blood marker associated with neuroaxonal injury in pwMS.

PMID 42881295
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PubMedEuropean journal of haematology2026-10-16

Chimeric Antigen Receptor T-Cell Therapy in T Cell/Histiocyte-Rich Large B-Cell Lymphoma: A Systematic Review and Meta-Analysis.

Koeck Stefan S, Leisch Michael M, Schöpf Bernd B, Fauser Josia J et al.

T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL) is a rare subtype of B-cell non-Hodgkin lymphoma with an aggressive clinical course and poor prognosis in the case of relapsed or refractory (r/r) disease. Recently, anti-CD19 chimeric antigen-receptor (CAR) T-cell therapy has been approved for the treatment of large B-cell lymphoma (LBCL), but subgroup-specific outcomes in these patients have never been reported. Therefore, only limited retrospective data on the safety and efficacy of CAR T-cell therapy in r/r THRLBCL is available. To comprehensively evaluate outcomes of CAR T-cell recipients with r/r THRLBCL, we performed a systematic literature review (SLR) and meta-analysis (MA). The SLR identified seven studies including 157 patients with r/r THRLBCL. Pooled overall response rates and complete remission rates were 48.3% and 30.4%, respectively. Median progression-free survival was 3.4 months, with a 12-month rate of 29.1% and median overall survival was 15.0 months, with a 12-month rate of 57.4%. Low- and high-grade cytokine release syndrome occurred in 68.3% and 4.5% of patients while low- and high-grade immune effector cell-associated neurotoxicity syndrome was seen in 23.1% and 12.9% of the patients. Overall, no unexpected safety signals were identified in r/r THRLBCL patients receiving CAR T-cell therapy but durable responses were only achieved in a subset of patients.

PMID 42885507
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PubMedInternational journal of molecular sciences2026-10-16

Immune Profiles Elicited by Different HBV Vaccine Modalities and Their Associations with Serological and Intrahepatic Viral Outcomes.

Xiao Huiying H, He Jinhang J, Zhu Lili L, Wang Songmei S et al.

Therapeutic vaccination for chronic hepatitis B aims to restore HBV-specific T-cell immunity and contribute to a functional cure. We systematically compared the immune profiles and antiviral efficacy of four vaccine modalities: recombinant HBsAg (rHBsAg), antigen-antibody immune complex (IC), a DNA vaccine encoding HBsAg (DNA-HBsAg), and an HBsAg-Fc fusion DNA vaccine (DNA-HBsAg-Fc). In naïve mice, the rHBsAg vaccine predominantly induced anti-HBs IgG responses, whereas the IC vaccine elicited strong anti-HBs IgG and detectable CD4+ T-cell responses. In contrast, DNA vaccines preferentially induced HBsAg-specific CD8+ T-cell immunity, which was further enhanced by fusion to the Fc fragment of human IgG1. In the pre-immunization/AAV-HBV model, high anti-HBs titers in rHBsAg and IC groups were associated with rapid clearance of circulating HBsAg but not with comparable reductions in HBcAg+ hepatocytes, whereas stronger HBsAg-specific CD8+ T-cell responses in the DNA vaccine groups were associated with greater reductions in HBcAg+ hepatocytes. However, in the therapeutic AAV-HBV model, all vaccine monotherapies showed limited and non-sustained antiviral efficacy, with only transient reductions in serum HBsAg and limited reductions in HBcAg+ hepatocytes. These findings highlight the distinct immune profiles of different vaccine platforms and an association between stronger HBsAg-specific CD8+ T-cell responses and reduced intrahepatic HBcAg expression, while underscoring the limited efficacy of vaccine monotherapy in the AAV-HBV model.

PMID 42883747
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PubMedJournal of hematology & oncology2026-10-16

Novel antibody-based regimens for large B-cell lymphoma: latest updates from the 2026 ASCO Annual Meeting.

Luo Gengcong G, Jiang Hongbin H, Chen Zegeng Z, Zhang Chunjia C

Large B-cell lymphoma (LBCL) encompasses a biologically and clinically heterogeneous group of aggressive B-cell lymphomas, and outcomes remain poor in high-risk and relapsed/refractory settings. Beyond conventional anti-CD20 monoclonal antibodies, the Fc-modified anti-CD19 antibody tafasitamab, the CD79b-directed antibody-drug conjugate polatuzumab vedotin, and CD20×CD3 bispecific antibodies are expanding treatment options across disease stages and patient populations. At the 2026 ASCO Annual Meeting, the phase 3 frontMIND trial provided randomized evidence for tafasitamab plus lenalidomide and R-CHOP in newly diagnosed high-risk disease, while OLYMPIA-3 further explored CD20×CD3 bispecific antibody intensification in the same setting. In older or treatment-unfit patients, early-phase nonrandomized studies of epcoritamab plus R-mini-CVP and mosunetuzumab monotherapy suggested the feasibility of chemotherapy-attenuated and chemotherapy-free approaches. In relapsed/refractory LBCL, SUNMO established a progression-free survival advantage for mosunetuzumab plus polatuzumab vedotin in autologous stem-cell transplantation (ASCT)-ineligible disease, whereas EPCORE NHL-2 supported epcoritamab-based salvage therapy in transplant-eligible patients. Collectively, these findings broaden the role of antibody-based regimens from frontline intensification and reduced-intensity treatment to nontransplant and transplant-directed salvage. Longer follow-up and randomized comparisons are needed to establish response durability, refine patient selection, and define optimal treatment sequencing.

PMID 42881391
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PubMedNutrients2026-10-16

Supplementation of Bacillus cereus Enhances Anti-Colitis Effects of Triple Probiotics in Mice: Correlative Evidence for a Gut Microbiota-Spermidine-Related Axis in Quadruple-Probiotic Protection.

Li Jixiang J, Du Xuxu X, Zhao Jing J, Li Wutang W et al.

Background: Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease associated with gut microbiota dysbiosis. The triple-probiotic mixture BLE (Bifidobacterium infantis, Lactobacillus acidophilus, Enterococcus faecalis) contains highly oxygen-sensitive strains prone to viability loss during gastrointestinal transit. Adding facultative-aerobic Bacillus cereus generates a four-strain probiotic formulation BLEB. This study aimed to determine whether adding B. cereus improves the anti-colitis capacity of BLE and explore the underlying microbiota-spermidine-related regulatory mechanism. Methods: Acute dextran sulfate sodium (DSS)-induced colitis mouse models were applied to compare the therapeutic effects of BLE and BLEB. We evaluated disease phenotype, intestinal epithelial barrier integrity, and splenic Treg/Th17 immune homeostasis. Dynamic 16S rRNA sequencing and untargeted intestinal metabolomics characterized gut microbial and metabolic alterations, with Spearman correlation for microbiota-metabolite association analysis. Transcriptomic profiling was performed on DSS-injured Caco-2 cells to examine molecular responses to spermidine. Results: BLEB exerted superior dose-dependent anti-colitis effects compared with BLE. BLEB enriched beneficial Lactobacillaceae and restored luminal polyamine metabolites including spermidine. Spearman correlation revealed significant positive correlations between Lactobacillaceae-affiliated genera and polyamine levels. In vitro, spermidine reversed DSS-provoked transcriptional perturbations and upregulated the transcription of glutathione-centered antioxidant-related genes in Caco-2 cells. Conclusions: Ecological synergy introduced by B. cereus may reshape gut microbiota and increase microbiota-related spermidine, partially contributing to the enhanced mucosal protection conferred by BLEB. This work provides pre-clinical evidence supporting the development of aerobic-anaerobic combined probiotic cocktails for auxiliary UC therapy.

PMID 42884615
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