YONGIN, South Korea--(BUSINESS WIRE)--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.
In terms of efficacy, the frequency of SBI was 0.02 for 12 months, satisfying the FDA guidance requirement of no more than one acute serious bacterial infection per person-year. The proportion of infusions with one or more infusion-related AEs was less than 40%; therefore, the study also met its primary safety endpoint.
"The submission of the GC5107 represents a major step towards our ultimate goal of expanding our business to the US marketplace," said Eun Chul Huh, Ph. D., President of GC Pharma. "GC5107 will provide meaningful treatment options to medical staffs and patients that further build on the success already achieved with our products in other parts of the world."
In general, the FDA has a 60-day filing review period to determine whether GC Pharma' Biologics License Application for GC5107 is complete and acceptable for filing.
About GC Pharma
GC Pharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Pharma is one of the leading plasma protein and vaccine product manufacturers in the world and has been dedicated to quality healthcare solutions for more than half a century. Green Cross Corporation updated its corporate brand to GC Pharma in early 2018. Green Cross Corporation remains the company's legal name.
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