Tonrol Bio-Pharmaceutical · 多克隆抗体 · 多克隆抗体
lyophilized hepatitis-B human immunoglobulin 是一种多克隆抗体，由Tonrol Bio-Pharmaceutical研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。
| 公司 | Tonrol Bio-Pharmaceutical |
| 药物类别 | 多克隆抗体, 疫苗, 抗体 |
| 给药途径 | Injectable (Others), Intravenous (IV) |
| 状态 | Approved |
lyophilized hepatitis-B human 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 infestations | Hepatitis B | ✓ Approved |
Yu Songfeng S, Yu Jun J, Zhang Wei W, Cheng Longyu L et al.
Mattar Ehab H EH, Zari Ali T AT, El-Fakharany Esmail M EM, El-Maradny Yousra A YA et al.
Egg yolk immunoglobulin Y (IgY) derived from avian sources, such as chickens, has attracted interest due to its low cost and rapid production. This study aimed to fabricate chitosan nanoparticles conjugated with IgY antibodies and polymyxin B as novel antibacterial nanocombinations to fight multi-resistant Salmonella enterica serovar Typhimurium (Salmonella Typhimurium) isolated from poultry. Chicken IgY was purified from egg yolk via caprylic acid precipitation and gel filtration. The developed polymyxin B-loaded nanocombinations, enhanced by IgY-polymyxin B-based NPs (IgY-Poly/ChNPs and IgY-coated-Poly/ChNPs), were designed to overcome the resistance limitations of polymyxin B. In this system, polymyxin B serves as the primary bactericidal agent, while the chitosan nanoparticle acts as a biocompatible carrier matrix, and the IgY coating serves as a functional shell to enhance stability and potentially interfere with bacterial surface attachment. The IgY-polymyxin B-based NPs exhibited a spherical morphology (124.2-290.7 nm) and a zeta potential of -26.5 to -46.9 mV. The formulations demonstrated potent inhibitory efficacy (12±0.98 - 21±0.91 mm) with MIC values of 0.125 to 2.0 mg/mL against Salmonella Typhimurium. These nanocombinations inhibited bacterial growth in a time- and dose-dependent manner. A significant downregulation of mcr-1 gene expression (3.97 to 8.7-fold) was observed in colistin-resistant Salmonella Typhimurium isolates, though this effect was isolate-dependent. SEM analysis showed extreme distortion in treated bacterial cells. Finally, the IgY-polymyxin B-based NPs showed minimal toxicity toward normal human skin fibroblast (HSF) cells, demonstrating them as possible candidates for future antimicrobial therapy.
Hogan Sam S, Shrestha Nisha N, Dixit Sameer S, Page Andrew A et al.
Hepatitis B virus (HBV) infections are a critical public health issue, especially in lower resource setting where the potential for chronic infections is increased. In Nepal an HBV vaccination program has been in place since the early 2000s, though knowledge and awareness of HBV has been recorded as being low within community settings. This study explored inequalities which may influence the overall healthcare system within Nepal regarding HBV, specifically vaccination programs, knowledge, awareness, and stigma associated with HBV. In-depth interviews (n = 21) were conducted with healthcare professionals from different healthcare districts in Nepal. These interviews were then transcribed before thematic analysis was performed. Several potential sources of inequality of service provision were identified. Awareness of HBV was reasonable among the participants; however, level of knowledge was variable. Participants felt while the vaccination program had been somewhat successful, there were still several areas in the Nepalese health system which needed to be strengthened to further mitigate risk of HBV infections. This included the need to strengthen and standardise vaccination processes within Nepal. Based on our findings, efforts to provide appropriate resources and equipment to community health centres needed to be reinforced. An increase is also needed in education and awareness programs around health issues, specifically those involving infectious diseases such as Hepatitis B at the community level. There also should be continued commitment to enhancing the healthcare services provided in rural and other underserved areas of Nepal.
Alhalabi Marouf M, Alshiekh Hussam Aldeen HA
This study aimed to determine the incidence of hepatitis B virus reactivation (HBVr) in patients with chronic or occult HBV infection who were treated with IL-12/23, IL-23 (together referred to as anti-IL-23/12), IL-17, or JAK inhibitors without antiviral prophylaxis. In addition, we sought to assess whether the risk of HBVr varies according to anti-HBs status among individuals who are anti-HBc positive. A systematic review and meta-analysis were conducted in accordance with PRISMA and MOOSE guidelines (PROSPERO: CRD42024614179). Twenty-nine studies including 912 patients were analysed. Incidence rates were pooled using a generalized linear mixed-effects model (GLMM). Heterogeneity was assessed using I2, τ2 and Cochran's Q. In a separate analysis, pooled odds ratios (ORs) were calculated using the random-effects GLMM with a logit link to compare HBVr risk in anti-HBc+ patients with and without anti-HBs antibodies. In HBsAg-positive patients, HBVr incidence was highest with JAK inhibitors (40%; 95% CI: 16%-70%), followed by IL-17 (28%; 95% CI: 14%-46%) and IL-12/23 or IL-23 inhibitors (10%; 95% CI: 3%-29%), with minimal heterogeneity. Among HBsAg-negative/anti-HBc+ patients, HBVr risk remained low (1%-4%). Anti-HBs negativity was associated with a statistically non-significant increase in the risk of hepatitis B virus reactivation (OR 1.13, 95% CI 0.35-3.61), although the magnitude of this association was modest. HBVr is a substantial risk in untreated HBsAg-positive patients receiving JAK or IL-17 inhibitors. Reactivation remains uncommon in anti-HBc+ individuals, particularly those with anti-HBs. These findings support serostatus-based risk stratification and the need for individualized antiviral prophylaxis.
Hu Haiyun H, Lv Mengjiao M, Wang Xiaohui X, Shang Xinci X et al.
Hepatitis delta virus (HDV) is a satellite RNA virus that requires hepatitis B virus (HBV) for propagation but replicates its genome independently in the nucleus. The small form of the hepatitis delta antigen (S-HDAg) is essential for replication and is regulated by post-translational modifications. Acetylation at lysine 72 (K72ac) enables S-HDAg to interact with the bromodomain (BRD) of the host chromatin remodeler bromodomain adjacent to zinc finger domain protein 2B (BAZ2B) to promote viral replication. However, the structural basis for this interaction has remained elusive. Here, we provide structural and biophysical insights into this interaction through quantitative binding assays and X-ray crystallography. Isothermal titration calorimetry revealed that BRDs of BAZ2B and its close homolog BAZ2A bind to the viral peptide weakly, with BAZ2A-BRD exhibiting a modestly higher affinity. The crystal structure of BAZ2A-BRD in complex with the S-HDAg-K72ac peptide demonstrates an inverted binding orientation relative to canonical histone ligands, rationalizing the weak interaction. Mutagenesis studies confirmed the critical binding interface both in vitro and in cells. These findings elucidate the molecular mechanism by which HDV co-opts host BAZ2 bromodomains via a unique, weak-affinity interaction, providing a structural framework for understanding viral replication.
Leite Geovana S F GSF, Sullivan John J, Filioglou Dimitrios D, Kounelis Matina M et al.
Relapse and graft-versus-host disease (GvHD) remain primary causes of treatment failure in patients with B-cell acute lymphoblastic leukemia (B-ALL) undergoing allogeneic hematopoietic cell transplantation (allo-HCT). While abatacept (ABATA) effectively mitigates GvHD via CD28-costimulation blockade, there is significant concern that it concurrently diminishes graft-versus-leukemia (GvL) effects, potentially leading to higher relapse rates. We investigated whether blinatumomab (BLINA) retains antileukemic efficacy in the presence of ABATA using in vitro assays and humanized NOD.Cg-Prkdcscid Il2rgtm1Wjl Tg(IL15)1Sz/SzJ (NSG-IL15) and NOD.Cg-Prkdcscid Il2rgtm1Wjl/SzJ (NSG) mouse models. In vitro and ex vivo flow cytometry-based cytotoxicity, degranulation (CD107a), cytokine production (interferon (IFN)-γ), and activation-marker (CD25, CD69, CD137, OX40) assays were performed using healthy donor peripheral blood mononuclear cells (PBMCs) (pretreated±ABATA) against leukemia or lymphoma cell lines (RS4;11, NALM-6, and JEKO-1) in the presence or not of BLINA. In vivo human PBMC-reconstituted NSG-IL-15 mice bearing RS4;11 B-ALL xenografts were treated with vehicle, monotherapy (BLINA or ABATA), or combination therapy. Leukemia burden and immune reconstitution were assessed through week 4; GvHD scores and overall survival were monitored longitudinally. ABATA did not impair BLINA-mediated cytotoxicity across multiple effector-to-target ratios against any of the cell lines, nor did it reduce BLINA-induced degranulation, IFN-γ production, or activation marker expression. In vivo, BLINA monotherapy significantly reduced leukemia burden, but resulted in early mortality due to severe GvHD. Conversely, ABATA markedly reduced GvHD severity. The combination of BLINA and ABATA preserved potent antileukemic efficacy while significantly extending median survival by 35 days compared with tumor controls (p<0.0001). Although ABATA attenuated T-cell expansion and differentiation, BLINA-driven cytotoxic function was maintained, even after prolonged in vivo exposure to cytotoxic T-lymphocyte-associated protein 4-immunoglobulin (CTLA-4-Ig). These findings provide preclinical proof-of-concept that BLINA and ABATA can be combined to uncouple GvL from GvHD. This strategy preserves CD28-independent T-cell cytotoxicity while limiting allo-reactivity, providing a strong rationale for investigating this combination in the post-transplant setting.
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