GC Pharma announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to its Biologics License Application (BLA) for ‘ALYGLO (Immune Globulin Intravenous (Human), 10% Liquid)'. The FDA issues a CRL to indicate that the review cycle for an application is complete but the application cannot be approved in its current form. The FDA recommended a pre-license inspection of GC Pharma Ochang facility in order to support approval of the Company's application.

GC Pharma conducted a Remote Interactive Evaluations by the FDA in Fourth Quarter 2021 due to restrictions on travel related to the COVID-19 pandemic. The company has confirmed that GC Pharma submitted all required documents for its BLA. ‘ALYGLO' demonstrated positive results in a Phase III study in North America, meeting its primary efficacy and safety endpoints for FDA guidance requirement.