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Intravenous human immunoglobulin (pH4) is a plasma-derived biologic developed and manufactured by Zhejiang Haikang Biological Products, a subsidiary of Shanghai RAAS Blood Products. Composed of pooled human immunoglobulin G (IgG) extracted from healthy donor plasma, the product contains at least 95% IgG and is formulated at pH 4.0 to maintain stability and minimize aggregate formation during storage and administration. It functions by providing passive immunity through a broad spectrum of antibodies and exerting immunomodulatory effects via Fc receptor modulation, complement inhibition, and cytokine neutralization. It is approved in China for the treatment of primary immunodeficiency disorders (such as X-linked agammaglobulinemia and common variable immunodeficiency), autoimmune diseases, Kawasaki disease, and idiopathic thrombocytopenic purpura (ITP).
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