human cytomegalovirus intravenous immunoglobulin (pH4)

human cytomegalovirus intravenous immunoglobulin (pH4) is a plasma-derived hyperimmune globulin containing high titers of neutralizing antibodies against human cytomegalovirus (HCMV). It is prepared from the plasma of healthy donors with high levels of anti-CMV antibodies, using purification processes such as caprylic acid precipitation and ion-exchange chromatography, followed by low pH (pH 4) incubation and nanofiltration for viral inactivation and removal. The drug is designed to provide passive immunity by neutralizing cytomegalovirus, thereby preventing or treating CMV viremia and related diseases in immunocompromised patients, such as those undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Chengdu Rongsheng Pharmaceutical (a subsidiary of Tiantan Biological) was developing the drug in China, but terminated its Phase III clinical trial and subsequent development in January 2024.

Other names

CMV pH4 human immunoglobulinCMV-IVIG (pH4)cytomegalovirus immunoglobulin intravenoushuman cytomegalovirus intravenous immunoglobulin静注巨细胞病毒人免疫球蛋白静注巨细胞病毒人免疫球蛋白（pH4）