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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

PubMedFrontiers in cellular neuroscience2026-11-12

Immunoglobulins and Efgartigimod reduce neuronal activity in primary rat cortical neuron cultures.

Marti Bautista Felix F, Nazarzadeh Nilufar N, Genseke Niklas N, Groß Elena E et al.

Immunoglobulin-based therapies are increasingly used to modulate neuroinflammatory diseases, yet it remains unclear whether they directly affect neuronal function. Here, we provide evidence that primary rat cortical neurons express both the inhibitory Fc gamma receptor IIb (FcγRIIb) and the neonatal Fc receptor (FcRn), as assessed by immunocytochemistry and mRNA analysis. FcγRIIb expression was upregulated under proinflammatory conditions, indicating inflammation-dependent regulation. Using microelectrode array recordings, we observed that immunoglobulin treatment reduced neuronal activity under both physiological and inflammatory conditions. Similarly, Efgartigimod, a high-affinity FcRn blocker, was associated with a sustained reduction in neuronal activity, with the observed effects suggesting a trend toward dose dependence under control conditions. Together, these findings provide proof-of-concept evidence that primary cortical neuronal cultures respond to immunoglobulins and Efgartigimod in vitro and highlight neuronal Fc receptor signaling as a promising avenue for future studies.

PMID 43016485
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PubMedJournal of clinical immunology2026-11-12

A de novo IKZF4 Variant Underlies Hypogammaglobulinemia and Increased Infection Susceptibility through Downregulating the NF-κB Pathway.

Fan Shiqi S, Wang Rongrong R, Tang Kaichen K, Xie Lina L et al.

Inborn errors of immunity (IEI) are a group of complex diseases characterized by reduced immunity and increased susceptibility to external pathogens, autoinflammation, autoimmune conditions, and/or malignancy. The IKAROS zinc-finger (IKZF) family is a group of C2H2 zinc-finger transcription factors that includes IKAROS (IKZF1), HELIOS (IKZF2), AIOLOS (IKZF3), EOS (IKZF4), and PEGASUS (IKZF5). Variants in IKZF have been reported to cause human IEI except IKZF4. This research aimed to identify the pathogenicity and underlying mechanisms of IKZF4 as a novel candidate gene for IEI. Here, we used whole-exome sequencing to identify candidate variants of IEI. Western blotting, quantitative polymerase chain reaction, immune staining, co-immunoprecipitation, flow cytometry, Luminex assays, and single-cell RNA sequencing were used to explore the phenotypes and functional effects in cell and mouse models. An 11-month-old patient presented with repeated fever and convulsions accompanied by persistently reduced immunoglobulin levels and abnormal immune indices, which supported the diagnosis of IEI. A de novo c.1472delG variant (GRCh37/hg19, NM_022465.3) in IKZF4 was selected as the candidate variant for IEI. The c.1472delG variant caused reduced EOS expression and truncated protein (predicted molecular weight ~ 57 kDa), defective pericentromeric heterochromatin targeting, and impaired protein interactions of EOS. A mouse model harboring the corresponding variant in Ikzf4 (Ikzf4+/c.1475delG) showed a proinflammatory switch in regulatory T cells, accompanied by reduced levels of immunoglobulins and a decreased ratio of marginal zone B cells after lipopolysaccharide stimulation, which were potentially caused by the down-regulated transcriptional regulation of EOS on the nuclear factor kappa-B pathway. This research identified IKZF4 as a novel candidate gene for IEI, advancing our knowledge of the IKZF family and the complexity of human IEI.

PMID 43015517
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PubMedRadiology case reports2026-11-12

Primary pulmonary MALT lymphoma with probable isolated light chain deposition disease: Case report and literature review.

Elghoul Rachad R, Weingartz Lucas L, Hayat Fateh F, Evans Juanita J et al.

Primary pulmonary extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) is an uncommon lymphoproliferative disorder with variable imaging manifestations that may overlap with infectious, inflammatory, and neoplastic processes. Light chain deposition disease (LCDD) is a rare monoclonal immunoglobulin deposition disorder that may occur in association with indolent B-cell lymphoproliferative disease, although isolated pulmonary involvement remains uncommon. We present the case of a 39-year-old woman initially found to have numerous bilateral pulmonary, hilar, and mediastinal nodules, many demonstrating eccentric calcifications, which raised concern for metastatic disease in the setting of a prior malignancy. Multiple biopsies were initially inconclusive, and serial imaging over several years demonstrated progressive ground-glass and multiseptated cystic changes; subsequent biopsy of an enlarging left lower-lobe lesion, together with molecular evidence of clonal immunoglobulin light-chain gene rearrangements, established the diagnosis of pulmonary MALT lymphoma. Following systemic therapy, surveillance imaging demonstrated development of new peripheral soft-tissue nodular components along several pre-existing cystic lung lesions, highly suggestive of superimposed kappa light chain deposition disease. This case highlights the uncommon association between pulmonary MALT lymphoma and LCDD and showcases the evolving radiologic appearance of these processes over prolonged follow-up. Recognition of cystic change and calcified or cyst-associated nodules in patients with pulmonary MALT lymphoma may suggest an associated light chain deposition disorder and prompt appropriate radiologic-pathologic correlation.

PMID 43017492
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PubMedFrontiers in immunology2026-11-12

Case Report: Cytomegalovirus retinitis in an HIV-negative patient with splenic mantle cell lymphoma treated with bendamustine-rituximab.

Tsai Yi-Hsien YH, Lin Hsien-Chung HC, Yang Wen-Chi WC, Lin Ta-Jen TJ et al.

Cytomegalovirus (CMV) retinitis following bendamustine-containing therapy is a rare opportunistic infection with limited published evidence, and its optimal management in human immunodeficiency virus (HIV)-negative patients remains poorly defined. A 29-year-old man with stage IV splenic mantle cell lymphoma (MCL), previously treated with R-CHOP followed by bendamustine-rituximab (BR) plus ibrutinib, developed progressive bilateral visual symptoms and abdominal pain approximately three months after completing BR therapy. Colonoscopic biopsy confirmed CMV colitis, and CMV retinitis was confirmed in the right eye, with subsequent virological confirmation of intraocular CMV involvement in the left eye. Despite initial induction therapy with intravenous ganciclovir followed by oral valganciclovir, right-eye CMV retinitis progressed, necessitating repeated intravitreal ganciclovir injections and re-induction with intravenous ganciclovir. Immunologic evaluation revealed profound cellular and humoral immune dysfunction, including severe CD4+ lymphopenia (109 cells/μL) and hypogammaglobulinemia, while HIV infection and lymphoma relapse were excluded. Intravenous immunoglobulin (IVIG) replacement therapy was initiated. Because of the prolonged ocular disease course and delayed immune reconstitution, extended oral valganciclovir maintenance and multiple intravitreal ganciclovir injections were required. Serial follow-up demonstrated gradual CD4+ T-cell recovery (109 to 352 cells/μL) and increasing circulating CD19+ B-cell proportions (4.9% to 13.7%), in parallel with sustained virological control. By June 2026, visual acuity remained preserved with no evidence of active retinitis, and both aqueous humor and blood CMV polymerase chain reaction (PCR) assays were undetectable. Given sustained retinal inactivity, virological suppression, and continued lymphoma remission, antiviral therapy was discontinued. This case highlights that cumulative therapy-associated immune dysfunction may predispose HIV-negative patients to CMV retinitis, with BR representing an important contributing exposure. For CMV retinitis in HIV-negative patients, treatment duration should be individualized according to ophthalmic findings, virological response, and stability of the underlying hematologic disease rather than relying solely on CD4+ T-cell counts.

PMID 43016696
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PubMedFrontiers in immunology2026-11-12

High efficacy and tolerability of daratumumab-based regimens in first-line treatment of patients with immunoglobulin light-chain amyloidosis: a real-world evidence analysis.

Cui Yajuan Y, Luo Yunya Y, Li Ji J, Yuan Lingli L et al.

Daratumumab was the first monoclonal antibody targeting cluster of differentiation 38 (CD38) to demonstrate high response rates in both untreated and pretreated cases of immunoglobulin light-chain (AL) amyloidosis. We conducted a single-center, retrospective real-world case series to evaluate the efficacy and safety of daratumumab as a first-line treatment option. Daratumumab was administered with bortezomib and dexamethasone (D-Vd), bortezomib, cyclophosphamide, and dexamethasone (D-VCd), or low-dose dexamethasone (Dd). Forty-four patients were eligible, including 14 patients with stage IIIb. By the 6-month milestone (N = 36), 21 (59%) patients achieved at least complete response (CR), 10 (28%) patients achieved very good partial response (VGPR), and 5 (14%) patients achieved partial response (PR). The cardiac response rate was 50% at 3 months, 69% at 6 months, and 84% at 12 months. The renal response rate reached 40% by the 6-month mark. Importantly, hematologic, cardiac, and renal response rates were generally comparable between stage IIIb and non-stage IIIb patients. After a median follow-up of 13 (range 2-45) months, 6 (14%) patients died, all with stage IIIb disease. The median overall survival (OS) was not reached, with a 6-month survival rate of 93% and a 1-year survival rate of 84%. Univariate analysis showed that Mayo stage IIIb, difference between involved and uninvolved free light chains (dFLC) ≥ 300 mg/L, and a time to treatment of more than 12 months were associated with poor overall survival. Lymphocytopenia emerged as the most prevalent hematologic adverse effect, with grade 3-4 lymphocytopenia observed in 32% of patients. Among non-hematologic adverse reactions, infection was observed in 39% of patients. Daratumumab demonstrates significant efficacy in treating newly diagnosed AL amyloidosis, with excellent hematologic and organ response rates, a remarkable safety profile, and favorable tolerability among AL amyloidosis patients. However, early cardiac mortality before responses could manifest underscores that advanced cardiac stage remains an adverse prognostic factor for OS.

PMID 43016680
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PubMedJACC. Case reports2026-11-12

Unraveling Severe Myocardial Dysfunction in Streptococcal Toxic Shock Syndrome: Beyond Septic Shock.

Dod Rohan R, Drury Jeffrey Kyle JK, Nguyen Catherine C, Santos Jillianne J et al.

Group A Streptococcus is a clinically important yet underrecognized cause of inflammatory myocardial dysfunction, capable of triggering shock through toxin-mediated injury and inflammation. A 19-year-old woman presented with progressive fatigue, severe hypotension, and a purpuric chest rash. Laboratory investigation showed rising troponin, leukocytosis, and lactic acidosis. Echocardiography and right heart catheterization revealed significant biventricular dysfunction. She developed shock requiring mechanical circulatory support with an Impella CP and extracorporeal membrane oxygenation. Corticosteroids and intravenous immunoglobulin were initiated empirically for presumed inflammatory myocarditis. Chest wall biopsy grew Group A Streptococcus, supporting the diagnosis of streptococcal toxic shock syndrome (STSS). Ultimately, she recovered cardiac function with mechanical circulatory support and targeted antimicrobial therapy. This case highlights severe, reversible myocardial dysfunction because of STSS. STSS can precipitate severe, reversible myocardial dysfunction representing a mixed septic-cardiogenic phenotype that may mimic fulminant myocarditis.

PMID 43018523
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