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human normal immunoglobulin G (NPB01)

✓ Approved

Nihon Pharmaceutical · 多克隆抗体 · 多克隆抗体

什么是 human normal immunoglobulin G?

human normal immunoglobulin G 是一种多克隆抗体,由Nihon 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)。

药物档案

商品名NPB01
公司Nihon Pharmaceutical
药物类别多克隆抗体, 抗体
给药途径Injectable (Others), Intravenous (IV)
状态Approved

治疗适应症

human normal immunoglobulin G 针对 11 个适应症,涉及 5 个治疗领域。

治疗领域疾病/病症分期
Skin and subcutaneous tissue disordersErythema multiforme✓ Approved
Nervous system disordersGuillain-Barre syndrome✓ Approved
Skin and subcutaneous tissue disordersPemphigoid✓ Approved
Skin and subcutaneous tissue disordersPemphigus✓ Approved
Infections and infestationsSalmonellosis✓ Approved

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相关研究文献

PubMedJournal of the peripheral nervous system : JPNS2026-08-08

Switching From Intravenous to Subcutaneous Immunoglobulin Maintenance Treatment in Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

Su Yelda Y, van Doorn Pieter A PA, Jacobs Bart C BC, Kuitwaard Krista K

Subcutaneous immunoglobulin (SCIg) is an alternative maintenance therapy to intravenous immunoglobulin (IVIg) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The CIDP guideline considers switching from IVIg to SCIg at an equivalent dosage reasonable; however, the optimal dosing strategy is unknown. This case series examines whether a 1:1 IVIg-to-SCIg switch maintains clinical stability. IVIg-dependent, clinically stable CIDP patients who switched from IVIg to SCIg in the Erasmus Medical Center were retrospectively evaluated. Clinical deterioration was defined as a decline in grip strength or muscle strength, or an increase in disability based on minimal clinically important difference criteria within 4 months after the switch. A total of 10 consecutive CIDP patients on stable IVIg regimens switched to an equivalent (1:1) SCIg dose. One patient remained clinically stable, while nine patients deteriorated. Three of these became clinically stable after increasing the SCIg dose to 1:1.3 or 1:1.5, whereas three patients did not regain stability despite a dose increase to 1:1.3. Clinical stability was maintained in the patient receiving a low dose (0.4 g/kg every 3 weeks), whereas patients receiving higher doses (≥ 1 g/kg every 3 weeks) deteriorated. Five patients switched back to IVIg, while five remained on SCIg throughout follow-up. A 1:1 IVIg-to-SCIg switch was insufficient to maintain clinical stability in most CIDP patients, including those on higher IVIg maintenance doses. Some but not all patients regained stability after increasing the SCIg dose. Optimal dose adjustment strategies, including whether temporary higher dosing is required, remain to be determined in future studies.

PMID 42568325
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PubMedAnimal reproduction science2026-08-08

Immunocrit in neonatal piglets: Importance and influencing factors through the eyes of a practitioner.

Arsenakis Ioannis I, Kargadou Evgenia E, Maes Dominiek D, Zoidis Evangelos E

This review critically reflects on the use of immunocrit in neonatal piglets as an indicator of passive immunity status. Under intensive production conditions and with the development of hyperprolific sow lines, reliable techniques are required to objectively assess the success of passive immunity transfer to the piglets. The immunocrit is a cost-effective indirect method for assessing immunoglobulin concentration in serum or plasma samples obtained 12-48 h after the birth of the first piglet, by using the principle of protein precipitation. Reduced growth performance, delayed development, greater vulnerability to illness, and higher pre-weaning mortality are all consistently associated with low immunocrit readings. Higher numbers, on the other hand, indicate effective immunoglobulin absorption and better long-term productivity. Various management strategies, including split suckling, cross-fostering, and farrowing system design, directly influence immunocrit values by affecting colostrum intake and competition among piglets. Certain interventions, such as oxytocin administration or anti-inflammatory treatments, may influence colostrum composition or farrowing conditions, but they do not always result in appreciable changes in immunocrit levels. Its usefulness, quickness, and field application make it an important tool in contemporary swine production, even though it lacks the analytical precision of enzyme-linked immunosorbent assay and radial immunodiffusion that quantify individual immunoglobulin isotypes, such immunoglobulin G. For herd level interpretations the immunocrit results should be complementary to the evaluation of the farrowing and colostrum management practices, the sow diet and the handling of the piglets in supporting corrective measures prenatally.

PMID 42566940
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PubMedJournal of immunology (Baltimore, Md. : 1950)2026-08-08

IgA binding characteristics of golden hamster and ferret Fcα receptors.

Ge Xiaoxuan X, Stoner Matthew R MR, Weiner Joshua A JA, Parigela Sarah S SS et al.

Golden hamster (Mesocricetus auratus) and ferret (Mustela putorius furo) are important animal models in studies of human infectious disease. They are used widely to investigate pathogen-spreading mechanisms and host immunology to evaluate the safety and efficacy of small molecules, biologic drugs and vaccines. To this end, immunoglobulin A (IgA) and its Fcα receptor (FcαR) play critical roles in humans but are not well characterized in these 2 species. Golden hamster and ferret IgA and FcαR were recombinantly expressed, purified, and characterized for N-linked glycosylation site occupancy and binding affinity. Based on sequence and structural alignments, hamster IgA showed greater similarity to human IgA than did ferret, and hinge domains in both small animal models suggested greater structural homology to human IgA2 than IgA1. Despite considerable sequence divergence in both immunoglobulins and receptors, and the lack of binding between ferret FcαR and ferret IgA, human IgA bound to both hamster and ferret FcαR with high affinity. Further, differences in dissociation rates were dependent on test format, suggesting that the 2:1 stoichiometry of human FcαR: IgA is recapitulated in these animals. Overall, this work suggests the suitability of these animals to model protection or pathology driven by interactions between human IgA and host FcαR and will aid in critical and confident interpretation of infection and immunization studies in each species.

PMID 42568045
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PubMedJournal of the Korean Society of Radiology2026-08-08

Bilateral Infraorbital Nerve Thickening in Immunoglobulin G4-Related Ophthalmic Disease.

Yi Juyeon J, Ban Ji Yoon JY, Sim Yongsik Y

PMID 42568859
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PubMedThe Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation2026-08-08

Prognostic Significance of Myocardial Blood Flow Reserve and Stress Myocardial Blood Flow in the Assessment of Cardiac Allograft Vasculopathy in Heart Transplant Recipients.

Stanton Liam J LJ, Prasad Nikil N, Einstein Andrew J AJ, O'Gorman Kevin J KJ et al.

Cardiac allograft vasculopathy limits longevity following heart transplantation (HT). Non-invasive physiologic assessment with cardiac PET provides prognostic significance. We sought to assess the relative prognostic relevance of stress myocardial blood flow (sMBF) and myocardial blood flow reserve (MBFR) on post-transplant outcomes. All adult single-organ HT recipients who underwent 13N-ammonia PET myocardial perfusion imaging between 2016-2019 were included with a median follow-up of 7.2 years. Patients were categorized by MBFR (normal MBFR >2.0, low MBFR ≤2.0) and sMBF (normal sMBF >1.7 mL/min/g, low sMBF ≤1.7 mL/min/g) values into three groups: concordant normal, discordant, or concordant low. Among 454 patients (25.8% female, median age 59 years, median time since HT 7.2 years), 287 (63.2%) had concordant normal MBFR and sMBF, 72 (15.9%) had discordant values (37 MBFR low, 35 sMBF low), and 95 (20.9%) were concordant low. Reductions in both MBFR and sMBF had an over 3-fold increased risk of death or retransplantation compared to those with both normal values (HR 3.3, 95% CI 2.2-4.8, p<0.0001). The risk remained elevated for those with discordant values, though magnitude of risk was lower (HR 2.5, 95% CI 1.6-3.9, p=0.0001). Only an isolated reduction in MBFR (HR 3.3, 95% CI 1.9-5.6, p<0.0001), not in sMBF (HR 1.7, 95% CI 0.8-3.3, p=0.14), conferred significant risk. Rate pressure product correction did not impact results. In this cohort, reduction in both sMBF and MBFR was associated with the highest risk of death or retransplant during a median follow-up of 7 years.

PMID 42567379
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PubMedPDA journal of pharmaceutical science and technology2026-08-08

Advancing Subcutaneous Delivery: Evaluation of Near-Body Auto-Injector Systems for High-Volume Biologic Administration with Human Hyaluronidase: Poster Presented at PDA Week 2026.

Johnson Kallie K, Wangsnes Ryan R, Frantz Baylor B, Connor Robert J RJ et al.

Subcutaneous (SC) delivery of biologics is evolving to accommodate the greater volumes and doses required for efficacy. Conventional handheld auto-injectors are constrained by volume and speed limitations, prompting the development of high-volume auto-injectors (HVAIs) and wearable on-body injectors (OBI). A Near-Body Injector (NBI) system offers a novel approach by combining the benefits of high-volume delivery with hands-free operation, without the need for adhesive attachment associated with OBI's by using a standard winged infusion set and a mechanical priming mechanism incorporated into the device. This study evaluated the feasibility of a NBI system in a porcine model, delivering SC immunoglobulin alone and in combination with recombinant human hyaluronidase PH20 (rHuPH20), an enzyme known to enhance SC dispersion and absorption.Results demonstrated that the NBI system was easily primed and effectively delivered 10 mL SC. Co-formulation with rHuPH20 significantly improved injection performance, reducing delivery time by ∼13%, eliminating back-leakage, and decreasing swelling volume and induration at the injection site. These findings support the clinical potential of NBI systems for hands-free high-volume, high-dose biologic administration, offering an alternative to conventional SC delivery methods.

PMID 42567674
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