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Human normal immunoglobulin for intravenous injection (IVIG pH4) is a plasma-derived, highly purified immunoglobulin G (IgG) preparation developed by Nanyue Bio (a subsidiary of Shanghai RAAS). It is prepared from pooled human plasma of healthy donors and contains a broad spectrum of antibodies against various infectious agents. IVIG pH4 is approved for replacement therapy in patients with primary or secondary immunodeficiency diseases to restore IgG levels and provide passive immunity. It is also indicated for immunomodulation in immune-mediated inflammatory and autoimmune disorders, such as idiopathic thrombocytopenic purpura (ITP), Guillain-Barré syndrome, Kawasaki disease, and chronic inflammatory demyelinating polyneuropathy (CIDP). The therapeutic effects are mediated by the neutralization of pathogens and toxins, blockade of activating Fc-gamma receptors (FcγRs), upregulation of inhibitory FcγRIIb, saturation of neonatal Fc receptors (FcRn) to accelerate autoantibody clearance, and inhibition of complement-mediated damage.
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