human hepatitis B immunoglobulin is a polyclonal antibodies developed by Hualan Biological Engineering Co., Ltd.. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection.
human hepatitis B immunoglobulin is developed for 1 unique indication across 1 therapeutic area.
Therapeutic Area
Condition
Phase
Infections and infestations
Hepatitis B
✓ Approved
Related Research Articles
PubMedmedRxiv : the preprint server for health sciences2026-07-17
Anti-HBsAg antibody mAb19-LS enhances antiviral immunity in humans with chronic hepatitis B.
Wang Zijun Z, Tenuta Mary M, Ngoc Le Han H, Halling Svensgaard Siri Nana SN et al.
Chronic infection with hepatitis B virus (HBV) is characterized by persistent expression of hepatitis B surface antigen (HBsAg), which is associated with profound immune tolerance. Although nucleos(t)ide analogue therapy effectively suppresses viral replication, it neither eliminates HBV nor reverses virus-specific immune dysfunction. Here, we report the results of two parallel first-in-human, dose-escalation studies evaluating a single infusion of mAb19-LS, a long-acting IgG1 monoclonal antibody targeting HBsAg, in individuals with chronic HBV infection receiving nucleos(t)ide analogue therapy. mAb19-LS was generally safe and well tolerated and induced a mean 11-fold increase in antigen clearance. The magnitude and duration of HBsAg suppression were dependent on both baseline antigen levels and mAb19-LS dose, with suppression maintained for more than 36 weeks in individuals receiving the highest dose. Reduction of circulating HBsAg was associated with uptake of HBsAg-IgG immune complexes by monocytes and dendritic cells and inflammatory reprogramming of these antigen-presenting cells. Notably, proliferation of both CD4 + and CD8 + T cells, as well as interferon-γ and TNF-α production in response to HBV antigens, were significantly increased 24 weeks after infusion. Together, these findings demonstrate that mAb19-LS is generally safe and effectively accelerates HBsAg clearance while activating antigen presenting cells and enhancing antiviral T cell responses.
PD-1 blockade unleashes local hepatitis B virus-related B cell response inhibiting hepatocellular carcinoma.
Chen Shuling S, Wang Yuanqi Y, Chen Jingying J, Xie Wenxuan W et al.
The prevailing notion is that effector T cell activation mediates anti-PD-1 efficacy in cancer. Here, we conducted a mechanistic study parallel to our phase 2 trial of perioperative anti-PD-1 therapy in patients with resectable recurrent hepatocellular carcinoma (HCC) (NCT04615143) to study its mechanism of action. Late-recurrence patients present two distinct subtypes characterized by T cell or B cell dominant responses in the tumor microenvironment by dynamic single-cell multi-omics analysis. Clonal antibody repertoire analysis and spatially paired scRNA-seq/BCR-seq reveal somatic hypermutation promoting antibody binding against hepatitis B virus core antigen (HBcAg) within tumor tertiary lymphoid structures (TLSs) in these type B-late recurrence patients. Mechanistically, HBcAg is exported into the extracellular space, triggering local B cell and antibody responses and complement activation. In mice, these high-affinity HBcAg-reactive antibodies lead to complement-mediated antitumor activity with enhanced anti-PD-1 efficacy. Thus, we uncover enhanced anti-virus B cell immunity within the TLS as a mechanism to anti-PD-1 in HCC.
Letter to the Editor: Prevalence and Risk Factors of Significant Hepatic Fibrosis in Omani Patients with HBeAg-negative Chronic Hepatitis B Virus Infection: A Retrospective Study.
From the archives of MD Anderson Cancer Center: Crystal-storing histiocytosis associated with B-cell lymphoma.
Al-Rusan Omar O, Shen Qi Q, Medeiros L Jeffrey LJ
Crystal-storing histiocytosis (CSH) is rare morphologic manifestation of disease histologically characterized by benign histiocytes, usually numerous, filled with cytoplasmic eosinophilic crystals. More than 200 cases have been reported in the literature. In most CSH cases, affected patients also have a plasma cell neoplasm or B-cell lymphoma. We report a 61-year-old man with a remote history of resected colon adenocarcinoma. As part of surveillance imaging he was found to have a 5.5 cm right ureteral/periureteral mass causing hydronephrosis, multi-station lymphadenopathy and splenomegaly. CT-guided biopsy obtained from the mass showed that ≥95% was composed of sheets of histiocytes containing abundant cytoplasmic crystals. The remainder of the specimen was composed of small lymphocytes and plasma cells. Immunohistochemical analysis showed that the lymphocytes were mostly positive for CD5, CD20 and PAX5, and negative for CD3. The plasma cells were positive for monotypic cytoplasmic kappa, CD138 and MUM1/IRF4, and the histiocytes were positive for CD31, CD68, and CD163, with crystals positive for CD68 and MUM1/IRF4. Subsequent bone marrow evaluation with flow cytometry immunophenotypic analysis showed a small monotypic kappa-positive B-cell population positive for CD5, CD19, CD20 and CD23. These findings support the diagnosis of CSH with immunoglobulin crystals associated with B-cell lymphoma. We review the literature on CSH associated with immunoglobulin crystals and discuss the differential diagnosis.
PubMedLiver international : official journal of the International Association for the Study of the Liver2026-07-17
High Rates of Advanced Chronic Liver Disease in Patients With Chronic Hepatitis D Virus Infection in Uzbekistan.
Khodjaeva Malika E ME, Khikmatullaeva Aziza S AS, Ibadullaeva Nargiz S NS, Khudaykulova Gulnara K GK et al.
Chronic hepatitis B virus (HBV) infection is endemic in Uzbekistan. Previous data showed a high prevalence of anti-hepatitis D virus (HDV) antibodies in HBsAg-positive individuals. Limited data are available on disease severity, treatment availability and hepatocellular carcinoma (HCC) prevalence in patients with chronic HDV infection in Uzbekistan.
The Scientific Research Institute of Virology (SRIoV) is the leading medical and scientific reference centre for viral hepatitis in Uzbekistan. In this retrospective study, epidemiological, clinical and laboratory data were collected and analysed from all HBsAg-positive patients presenting to the SRIoV between June 2023 and May 2024. Data from HDV-coinfected and HBV-monoinfected patients were compared.
Data of 1393 individual patients were included. HDV coinfection was more prevalent than HBV-monoinfection (73.9% [n = 1030/1393]) vs. 26.1% [n = 363/1393]. HDV-infected patients were significantly younger (41.9 vs. 45.4, p < 0.001) and showed higher rates of cirrhosis (78.4% vs. 43.9%, p < 0.001) with the majority of patients being classified as Child-Pugh score B (57.8%). Only a minority of HDV-coinfected patients has ever received anti-HDV-directed treatment (0.4%, n = 4/1030). Consecutively, HDV RNA was detectable in 78.9% (812/1023) of patients. Quantitative HDV RNA was independently associated with ALT elevation > upper limit of normal. The HCC detection rate was low in both patient groups due to insufficient screening measures (HDV: n = 7/1030, HBV: n = 11/363).
In this retrospective cohort of 1393 individual patients, HDV coinfection exceeds HBV monoinfection in prevalence and disease severity. Most HDV-infected patients present with advanced liver disease and currently lack access to HDV-directed therapy.