Watson biological "intravenous immunoglobulin (pH4)" drug clinical research registration application accepted
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Last Update: 2020-04-03
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Source: Internet
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Author: User
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In the afternoon of January 29, Watson biology announced that the application for clinical research registration of "intravenous human immunoglobulin (pH4)" of Hebei Da'an Pharmaceutical Co., Ltd., the holding subsidiary of the company, was officially accepted by Hebei food and drug administration The product was developed and applied in accordance with relevant regulations and documents in accordance with the provisions of the new national pharmacopoeia standard Recently, it passed the formal review and on-site verification of Hebei food and drug administration, and its clinical research registration application was officially accepted It is reported that human immunoglobulin (pH4) by intravenous injection contains IgG antibodies against broad-spectrum antiviral, bacterial or other pathogens In addition, the idiotypic and idiotypic antibodies of immunoglobulin can form a complex immune network, so it has dual therapeutic effects of immune replacement and immune regulation After intravenous infusion, the IgG level in the blood of the recipient can be rapidly increased, and the anti infection ability and immune regulation function of the body can be enhanced Indications are: primary immunoglobulin deficiency, such as X-linked hypoimmunoglobulinemia, common variant immune deficiency, immunoglobulin G subtype deficiency, etc.; secondary immunoglobulin deficiency, such as severe infection, neonatal septicemia, etc.; autoimmune diseases, such as primary thrombocytopenic purpura, Kawasaki disease.
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