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human immunoglobulin (pH4)

✓ Approved

Sichuan Yuanda Shuyang Pharmaceutical Co Ltd · Polyclonal Antibodies · Polyclonal Antibodies

What is human immunoglobulin (pH4)?

human immunoglobulin (pH4) is a polyclonal antibodies developed by Sichuan Yuanda Shuyang Pharmaceutical Co Ltd. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

CompanySichuan Yuanda Shuyang Pharmaceutical Co Ltd
Drug ClassPolyclonal Antibodies, Antibody
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, Sichuan Yuanda Shuyang Pharmaceutical Co Ltd

Therapeutic Indications

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

Therapeutic AreaConditionPhase
Immune system disordersImmunodeficiency✓ Approved

Related Research Articles

PubMedJournal of pediatric gastroenterology and nutrition2026-11-11

Microbiome and immune development in preterm infants receiving powdered human milk-based fortification from the PUFFIN trial.

Cifuentes Maria Paula MP, Young Greg R GR, Nelson Andrew A, Palmer Jeremy J et al.

To determine the impact of powdered human milk-based fortification (PHMF) compared to powdered bovine milk-based fortification on gut microbiome and inflammation in preterm infants. Mechanistic study within randomised controlled trial in infants <32 weeks gestation or <1500 g birthweight, only receiving human milk and fully enterally fed without previous fortification, in two UK neonatal intensive care units (NICU). Stool and urine at recruitment (D0), weekly until day 21 (D21) and discharge. Microbiota (stool) and secretory immunoglobulin A (sIgA)/IgA (stool and urine) were evaluated at all time points and immune related proteins (IRP) (stool) at day 7 (D7) and D21. Twenty-eight patients (14 per arm; median gestation 27.18 ± 2.42 weeks) participated. One hundred and twenty-nine stools and 109 urines were collected. Analysis of gut microbiota (111 stools), sIgA (113 stools and 108 urines), and IRPs (52 stools) was performed. Fortifier type did not significantly impact stool alpha or beta diversity or specific taxa and explained <5% of variance at any time point, with site being most influential (14.7% at day 14 [D14], p = 0.04; 25.7% at D21, p = 0.007). Stool but not urine sIgA was higher in PHMF recipients. Whilst fortifier type was not associated with IRPs from D7 to D21, NICU site impacted IRPs. Fortifier type did not have a large impact on microbiota or IRPs but stool sIgA was higher in PHMF recipients. An association between NICU site and other outcomes was observed. ClinicalTrials.gov identifier: The Preterm milk fortification in neonates (PUFFIN) study was prospectively registered ISRCTN 22484792.

PMID 43010669
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PubMedCureus2026-11-11

Intestinal Paracoccidioidomycosis Masquerading as Crohn's Disease: Diagnostic Pitfalls in a Case Report.

Cerqueira Ana A, Seco Tiago T, Moniz Joana J, Lemos Bárbara B et al.

Paracoccidioidomycosis (PCM) is a systemic fungal infection caused by Paracoccidioides spp., predominantly found in Brazil. It primarily affects the respiratory system, while extrapulmonary involvement is rare. Disseminated PCM in immunocompetent hosts may be associated with exposure burden, host factors, delayed diagnosis, and disease phenotype. We present the case of a 28-year-old Brazilian man who had been living in Portugal for five months and presented to the emergency department with persistent abdominal pain lasting three weeks. Initial evaluation revealed mesenteric lymph-node conglomerates. During hospitalization, an extensive workup was performed, including screening for active neoplastic disease, immunosuppressive states, and active infection. A fourth-generation HIV combined antigen/antibody test was negative. Immunoglobulin levels were within the normal range (immunoglobulin A 160 mg/dL, immunoglobulin M 200 mg/dL and immunoglobulin G 1500 mg/dL). There was no history of immunosuppressive medication use including steroid or biologic, and no history of diabetes or transplantation. There was also no clinical or imaging evidence of solid or haematological malignancy. Immunophenotyping of peripheral blood and two lymph nodes showed no changes of pathological significance. Clinical, imaging, endoscopic, and histologic findings suggested Crohn's disease, although the presentation was atypical because of the extent of painful lymphadenopathy and hepatosplenomegaly. However, Periodic Acid-Schiff (PAS) and Ziehl-Neelsen staining were performed on the initial slides containing granulomas (inguinal lymph node and samples from the ileum and colon, but did not demonstrate evidence of infection at that time). A trial with high-dose corticosteroids was initiated.  Following subsequent deterioration, an axillary lymph-node was excised. Gomori-Grocott (GG) staining, which was only performed at this stage, revealed the "ship's pilot wheel" appearance. There was no isolation in cultures and serologic and polymerase chain reaction (PCR) testing for Paracoccidioides spp. could not be performed at our hospital. Therefore, the diagnosis of paracoccidioidomycosis was established based on histologic morphology, epidemiologic context, and suggestive clinical features. After the diagnosis was established, the initial slides were reviewed and GG staining was added, becoming clear that the fungal forms were already present in all the tested samples, but had gone unrecognized. Imported fungal infections in non-endemic areas present significant clinical challenges, including delayed diagnosis and limited clinician experience. In Portugal, only one private laboratory can perform PCR and serologic testing for paracoccidioidomycosis. This limitation highlights an important lesson from this case: a diagnosis cannot be made if the disease is not considered. This case may therefore serve as a useful resource for settings with similar diagnostic limitations. Given the extreme rarity of extrapulmonary PCM, this case highlights the need for a comprehensive diagnostic approach to intestinal granulomatous diseases, particularly in patients from endemic regions, and emphasizes the role of internal medicine in this diagnostic process.

PMID 43011942
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PubMedJPGN reports2026-11-11

A real-world comparison of celiac tissue transglutaminase immunoglobulin A antibody levels in pediatric patients using two different diagnostic kits.

Kori Michal M, Guz-Mark Anat A, Perets Tsachi Tsadok TT, Davidpur Amit A et al.

Pediatric celiac disease (CeD) may be diagnosed without a biopsy when tissue-transglutaminase (TTG) immunoglobulin A (IgA) antibodies are ≥10x the upper limit of normal (ULN) and anti-endomysial antibodies are positive in a second sample. The no-biopsy diagnosis demands a very high accuracy and reliability of the TTG diagnostic kits. Inter-assay differences may affect category classification. We compared TTG-IgA levels performed by two reliable kits: Bioplex 2200 and Liaison-XL in routine care. Using the Clalit Health Services database, we identified pediatric patients with paired TTG-IgA measurements from both kits within ≤14 days. Values were expressed as multiples of ULN and categorized: 10x ULN. Agreement was assessed for ≤7 and ≤14-day windows using Cohen's ĸ. Category discordance occurred in 17.4% (109/625) of paired tests within 14 days and 11.8% (38/321) within 7 days. Overall agreement was substantial (ĸ = 0.62 for 14 days; ĸ = 0.63 for 7 days). Concordance was high for negative results (96.0%), but significantly lower for the critical >10x ULN threshold at 14 days (88.2%, p = 0.009). Significant discordance between these two reliable TTG-IgA kits at 14 days, exceeding 10% in the >10x ULN category, warrants careful consideration when using the no-biopsy approach for CeD diagnosis, as assay choice may impact clinical classification.

PMID 43011603
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PubMedFrontiers in pediatrics2026-11-11

Characteristics of hospitalized children with immunoglobulin A vasculitis: a 7-year retrospective study of 119,217 pediatric inpatients in China.

Ma Yue Y, Wang Xinyu X, Zhang Ningning N, Liu Chang C et al.

Immunoglobulin A vasculitis (IgAV), formerly Henoch-Schonlein purpura (HSP), is the most common systemic vasculitis in children. This study aimed to systematically analyze the demographic, epidemiological, clinical, and infectious characteristics of pediatric IgAV using a large-scale real-world dataset. A retrospective study was conducted using inpatient discharge abstracts from Beijing Children's Hospital, Capital Medical University, spanning January 2016 to December 2022. A total of 119,217 pediatric patients (aged 18 years or younger) diagnosed with IgAV were enrolled. Demographic characteristics, clinical classification, infectious triggers, pathogen spectrum, and multisystem comorbidities and complications were systematically analyzed. Statistical analyses were performed using SPSS 26.0. A two-sided P < 0.05 was considered statistically significant. Among 119,217 enrolled patients, the mean age was 7.79 ± 3.17 years with a male-to-female ratio of 1.30:1. School-aged children (50.77%) and Han ethnicity (93.27%) predominated. Southern China (57.91%) and rural areas (56.91%) showed higher case volumes (both P < 0.001). The winter-spring period (November-March) concentrated 50.66% of cases (P < 0.001). Clinically, unspecified type was most common (57.02%), followed by renal type (20.04%). Renal-type cases showed a significant increasing trend (P < 0.001). Co-infections were present in 47.49% of patients. Mycoplasma pneumoniae was the most frequently recorded pathogen (5.82%), compared with Streptococcus pneumoniae (0.32%). Digestive system complications were most prevalent (4.97%). Pediatric IgAV in this large Chinese inpatient cohort demonstrated male predominance, a winter-spring peak, and an increasing proportion of renal-type classification (from 15.5% to 27.0% over 7 years). Mycoplasma pneumoniae was the most frequently recorded pathogen (5.82%). These findings suggest that systematic multi-pathogen screening (including Mycoplasma pneumoniae) and standardized long-term urinalysis follow-up may be warranted in the management of hospitalized pediatric IgAV patients.

PMID 43011018
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PubMedJournal of the science of food and agriculture2026-11-11

Whey protein hydrolysate alleviates ovalbumin-induced allergic responses in Brown Norway rats: associations with immunoglobulin E-related responses and the gut microbiota-short-chain fatty acid axis.

Wang Yi Y, Wang Xinze X, Chen Liang L, Zhang Xinxue X et al.

Whey protein hydrolysate (WPH) has considerable potential as a functional food ingredient; however, its role in alleviating allergic responses and the underlying mechanisms remain insufficiently understood, particularly the potential role of gut microbiota and their metabolites. This study characterized the structural changes of WPH following enzymatic hydrolysis, evaluated its effects on allergic responses in an ovalbumin-induced allergic rat model, and investigated the associated changes in gut microbiota and short-chain fatty acids (SCFAs) to explore their potential involvement in the antiallergic effects of WPH. Whey protein hydrolysate was prepared by two-step enzymatic hydrolysis. Compared with whey protein isolate (WPI), the amide I band shifted from 1651.85 to 1654.62 cm-1, and the α-helix content decreased from 34.67% to 23.23%, with increases in β-sheet (10.69% to 15.66%), β-turn (11.03% to 12.63%), and random coil (43.61% to 48.40%), indicating a more flexible conformation. Whey protein hydrolysate inhibited hyaluronidase concentration-dependently, reaching 70% inhibition at 60 g L-1. In an ovalbumin (OVA)-induced allergy model in Brown Norway (BN) rats, WPH was administered orally at 200, 500, and 1000 mg kg-1 day-1 for 42 days. Whey protein hydrolysate attenuated hypothermia and reduced serum immunoglobulin E (IgE), OVA-specific IgE (sIgE), histamine, and β-hexosaminidase levels, while ameliorating jejunal damage and mast cell degranulation (P < 0.05). WPH also increased the Richness, ACE, and Chao1 indices (P < 0.05). Whey protein hydrolysate alleviated allergic responses by attenuating systemic allergic responses, reducing mast-cell activation and allergic mediator release, and partially restoring gut microbial richness and diversity, supporting its potential as a functional food ingredient. © 2026 Society of Chemical Industry.

PMID 43010143
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PubMedMedicine2026-11-11

Current status and optimization strategies for immunoglobulin a nephropathy management in the Western Region of Chongqing, China: A cross-sectional study.

Dong Li L, Cai Min M, Tan Lian L

This cross-sectional study evaluated the quality of immunoglobulin A nephropathy (IgAN) care in Western Chongqing. It assessed patient demographics and associations between the Oxford Pathology Classification and laboratory indicators to identify priorities for local care improvement. We enrolled 73 patients with renal biopsy-confirmed IgAN from a tertiary hospital in Western Chongqing (January 2020-June 2023). Demographic data, Oxford Mesangial hypercellularity, Endocapillary proliferation, Segmental sclerosis, Tubular atrophy/interstitial fibrosis, and Crescents (histological classification system for IgAN) scores, and laboratory indicators were collected. Descriptive statistics were used to assess data completeness. Group comparisons and Spearman correlation analyses were performed. The 60 correlations between 12 laboratory indicators and 5 Mesangial hypercellularity, Endocapillary proliferation, Segmental sclerosis, Tubular atrophy/interstitial fibrosis, and Crescents (histological classification system for IgAN) components were evaluated as 1 Benjamini-Hochberg (BH) false discovery rate (FDR) family. The preoperative examination completion rate was 1.37%, whereas standardized renal pathology staining and IgAN pathological classification rates were both 100%; documented renin-angiotensin system blocker use among eligible patients and follow-up completion were 38.89% and 42.47%, respectively. After BH/FDR correction, sex was associated with occult blood (q = 0.013), red blood cell count (q = 0.000672), and hemoglobin concentration (q = 0.000436). Age group was associated with erythrocyte sedimentation rate (q = 0.009) and creatinine (q = 0.028), and body-weight group was associated with uric acid (q = 0.000188). In the Spearman analysis, the C score was positively associated with 24-h urinary protein (n = 66, ρ = 0.439, unadjusted P = .000226, q = 0.00451), whereas the M score was not (ρ = 0.115, P = .359, q = 0.552). This cross-sectional audit identified gaps in documented IgAN care and associations between pathology and laboratory profiles. The findings suggest local priorities for care improvement; the effects of management changes on clinical outcomes require longitudinal evaluation.

PMID 43012756
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