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Press release content from Business Wire. The AP news staff was not involved in its creation. GC Pharma Submits Biologics License Application to US FDA for Immune Globulin ‘GC5107’ February 26, 2021 GMT YONGIN, South Korea (BUSINESS WIRE) Feb 25, 2021 GC Pharma (006280.KS) today announced that it had submitted its Biologics License Application (BLA) for ‘GC5107’ (Immune Globulin Intravenous (Human),10% Liquid) to the United States Food and Drug Administration (FDA). GC Pharma demonstrated positive results in a Phase III study in North America, meeting its primary efficacy endpoint of acute serious bacterial infections (SBI). In the trials included in the submission, with PI (Primary Humoral Immunodeficiency) patients, all primary efficacy and safety endpoints corresponding to FDA guidelines were satisfied.

United statesSouth koreaHyungoo kangYelin junWoosub shinHansaem kimEun chul huhDrug administrationGreen cross corporationBiologics license applicationImmune globulin intravenousUnited states foodNorth americaPrimary humoral immunodeficiencyCross corporationBusiness wire