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human immunoglobulin (pH4)

✓ Approved

Shenzhen Weiguang Biological · Polyclonal Antibodies · Polyclonal Antibodies

What is human immunoglobulin (pH4)?

human immunoglobulin (pH4) is a polyclonal antibodies developed by Shenzhen Weiguang Biological. It is approved for therapeutic indications via intraarterial injection or intravenous (iv).

Drug Profile

CompanyShenzhen Weiguang Biological
Drug ClassPolyclonal Antibodies, Antibody
RouteIntraarterial Injection, Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Shenzhen Weiguang Biological

Therapeutic Indications

human immunoglobulin (pH4) is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Immune system disordersImmunodeficiency✓ Approved

Related Research Articles

PubMedMolecules (Basel, Switzerland)2026-10-16

Essential Oil-Containing Mouthrinses for Plaque and Gingivitis Control: Formulation Chemistry, Human Salivary Biomarkers, Mechanistic Evidence, and Research Priorities.

Sytykiewicz Hubert H

Selected essential oil (EO)-containing mouthrinses improve plaque and gingivitis control when used alongside mechanical oral hygiene, but their molecular effects in human saliva remain poorly defined. This narrative review integrates formulation chemistry, oral exposure, human salivary evidence, and mechanistic studies. Three studies identified in this review evaluated salivary immunoglobulin A, immunoglobulin G, or interleukin-1β. Differences in populations, co-interventions, sampling, and analytical methods limit comparison and do not establish reproducible modulation of a single biomarker. Other human studies assessed salivary flow, pH, proteomic responses, microbial counts, nitrate reduction, and oral biofilms. Mechanistic evidence largely derives from isolated constituents in cellular, animal, or computational models. A study of a complete zinc-containing formulation in human oral cells provides formulation-level evidence, but neither this study nor the constituent literature establishes target engagement after mouthrinsing in humans. Future trials should connect chemically characterized formulations and measured oral exposure with target-specific assays, validated salivary endpoints, microbial function, clinical outcomes, and safety. Current evidence supports selected formulations for plaque and gingivitis control; it does not establish an EO class effect or a validated salivary mechanism of clinical benefit.

PMID 42883182
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PubMedExperimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation2026-10-16

High Prevalence of Oxford MEST-C Lesions in Immunoglobulin A Nephropathy of Kidney Allografts: A Single-Center Study from Viet Nam.

Thai Kinh Luan KL, La Ngoc Thu Nguyen NTN, Hoang Tien Dat TD, Duong Nguyen Xuong NX et al.

We evaluated the clinical characteristics, Oxford 2016 histopathology features, and short-term outcomes of Immunoglobulin A nephropathy in kidney transplant recipients at Cho Ray Hospital, Ho Chi Minh City, Viet Nam. This retrospective, descriptive study included kidney transplant recipients with biopsy -proven immunoglobulin A nephropathy in kidney allografts identified in 2022. We analyzed patient death with a functioning graft as a competing event and not classified as graft failure. Immunoglobulin A nephropathy was present in 27.1 % (19/70 ) of allograft biopsies. Most recipients were male (73.7 %) and received grafts from living related donors (17 /19, 89.4 % ). The mean time from transplant to immunoglobulin A nephropathy diagnosis was 5.2 years. Median follow -up after biopsy was 48 weeks. Three components of the Oxford MEST -C were frequently observed, that is, mesangial hypercellularity M1 (73.7 % ), segmental glomerulosclerosis S1 (78.9 % ), and cellular /fibrocellular crescents C1 (26.3 % ). At the end of follow -up, 68.4 % of patients maintained graft function, 15.8 % required hemodialysis, and 10.5 % died from nonrenal causes with functioning grafts. Immunoglobulin A nephropathy was frequently observed in our patient cohort; however, the inability to distinguish recurrent disease from de novo disease fundamentally limited interpretation of the histopathology patterns. Moreover, given the short -term and multifactorial nature of the outcomes, together with the limitations of the Oxford MEST -C in the allograft setting, the independent prognostic significance of these lesions remains uncertain and requires further validation through larger prospective studies.

PMID 42885704
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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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PubMedmSphere2026-10-16

Characterization of the Peromyscus leucopus immunoglobulin germline repertoire and anti-OspA antibody response reveals conserved germline IGHV features among cricetid rodents.

Zhou Yu Y, Telford Sam R SR, Buchthal Joanna J, Esvelt Kevin K et al.

Peromyscus leucopus (P. leucopus) is an important reservoir host for several zoonoses, including Borrelia burgdorferi (B. burgdorferi), the causative agent of Lyme disease. However, the immunoglobulin germline repertoire underlying antibody responses in this reservoir host remains poorly defined. In this study, we characterized the immunoglobulin variable genes of P. leucopus and identified 12 IGHV, 12 IGKV, and 3 IGLV gene families comprising 129, 87, and 12 genes, respectively. These genes exhibited similar usage patterns to those of Mus musculus (M. musculus). We also identified a high-divergence region (HDR) within the germline IGHV loci of three Borrelia sp.-susceptible Cricetidae species, P. leucopus, Peromyscus maniculatus (P. maniculatus), and Arvicola amphibius (A. amphibius). Compared with the corresponding regions in Muridae species, the Cricetidae HDRs are expanded and contain a large number of IGHV genes. To investigate the antigen-specific features of the repertoire, we analyzed the antibody responses of P. leucopus to B. burgdorferi outer surface protein A (OspA), a highly immunogenic tick midgut adhesin involved in midgut colonization. Comparative analysis of more than 140 IGHV genes from immunized P. leucopus showed that germline IGHV genes encoding anti-OspA antibodies exhibited higher sequence similarity to corresponding germline IGHV genes in P. maniculatus and A. amphibius than did P. leucopus germline IGHV genes not associated with anti-OspA responses.IMPORTANCEThis study characterized the immunoglobulin gene repertoire of Peromyscus leucopus and revealed extensive diversity across its variable-region loci. Analysis of antibody response to outer surface protein A (OspA) showed that germline IGHV genes encoding anti-OspA antibodies showed higher sequence similarity to their corresponding germline IGHV genes in other Borrelia-susceptible cricetid rodents, suggesting that conserved germline IGHV features are associated with OspA recognition. These findings lay the foundation for further understanding of antibody responses in this important reservoir host.

PMID 42885934
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PubMedCancers2026-10-16

Immunoglobulin A Subtype and Survival After Upfront Autologous Stem Cell Transplantation in Multiple Myeloma: A Real-World Cohort from the Bortezomib Era.

Güllü Koca Tuba T, Koca Nizameddin N, Hunutlu Fazıl Çağrı FÇ, Yanık Ahmet Mert AM et al.

Immunoglobulin isotype is recorded at diagnosis in every patient with intact-immunoglobulin multiple myeloma, but is not retained in the ISS, R-ISS, or R2-ISS. We analyzed 196 consecutive patients with IgA or IgG myeloma who underwent upfront autologous stem cell transplantation at a single center (2009-2023). The primary endpoint was progression-free survival (PFS); overall survival (OS) was the secondary endpoint. Cox models used information available at transplantation, including the induction regimen and transplant year, in the complete-case set (n = 131) and after multiple imputation (n = 196). Median PFS was 14.8 versus 30.5 months and OS 43.2 versus 94.2 months in IgA versus IgG patients (both p < 0.001). IgA isotype was associated with inferior PFS (adjusted HR 1.85, 95% CI 1.13-3.02; imputed HR 1.83, 95% CI 1.22-2.73). For OS, the HR was 1.68 (0.98-2.88) in the complete-case analysis and 1.91 (1.24-2.94) after imputation, so its magnitude is uncertain. Models with maintenance gave 1.87 and 1.82. Progression documentation differed by maintenance status. Cytogenetic data were too incomplete to assess independence from genomic risk. In a bortezomib-era transplant cohort, IgA isotype was associated with inferior PFS; the association with OS was of uncertain magnitude. The finding is hypothesis-generating and requires validation in cohorts with complete cytogenetic characterization.

PMID 42882872
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PubMedNeurology and therapy2026-10-16

Real-World Health Care Resource Utilization, Adherence, and Persistence Following Subcutaneous IgPro20 Initiation Among US Patients with Chronic Inflammatory Demyelinating Polyneuropathy.

Kuatov Batyrkhan B, Weng Shicheng S, Hubsch Alphonse A, Undreiner Laurence L et al.

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare, inflammatory peripheral nervous system disorder. Intravenous immunoglobulin (IVIG) has been the standard maintenance therapy, but since 2018, Immune Globulin Subcutaneous (Human), 20% liquid (IgPro20), a subcutaneous immunoglobulin (SCIG) therapy, has offered an alternative, demonstrating benefit in maintaining CIDP improvement and remission. This study aimed to evaluate real-world healthcare resource utilization (HCRU), adherence, and persistence following IgPro20 initiation in patients with CIDP, given limited real-world evidence on these SCIG-related outcomes. This observational, descriptive study used Optum's de-identified Clinformatics® Data Mart Database (Optum® CDM) data to examine adults with CIDP initiating IgPro20 (index date). Adult patients with ≥ 2 CIDP diagnosis claims at least 14 days apart and ≥ 6 months of enrollment pre- and post-index between January 1, 2014 and December 31, 2024 were included. Those on other SCIG products were excluded. Patients with CIDP initiating IgPro20 (N = 207) were 53.6% male, with a median age of 60.00 and few comorbidities. Acute care utilization was low at baseline and decreased further following IgPro20 initiation, with inpatient and emergency department visits per patient per year (PPPY) decreasing from 0.52 to 0.42 and from 1.00 to 0.85, respectively. Overall, outpatient (OP) visits increased from 60.62 PPPY pre-initiation to 92.61 PPPY in month 1 post-initiation, driven by visits for CIDP-related home administration, notably for nursing/home-care for self-administration training. OP visits subsequently declined to 67.43 PPPY by month 6 (n = 141). Most patients (69.1%) were highly adherent, and 63.8% remained persistent at 6 months. Patients on IgPro20 administration demonstrated therapy adherence and decreased utilization of resource-intensive settings. While initial increases in outpatient and home care visits likely reflect training for at-home therapy, other outpatient healthcare utilization decreased. High persistence and adherence indicate sustained, uninterrupted therapy.

PMID 42881325
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