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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 States , South Korea , Hyungoo Kang , Yelin Jun , Woosub Shin , Hansaem Kim , Eun Chul Huh , Drug Administration , Green Cross Corporation , Biologics License Application , Immune Globulin Intravenous , United States Food , North America , Primary Humoral Immunodeficiency , Cross Corporation , Business Wire , Pharmaceutical Manufacturing , Health Care Industry , Medical Biotechnology Industry , East Asia , ஒன்றுபட்டது மாநிலங்களில் , தெற்கு கொரியா , ஏன் சுல் ஹூ , பச்சை குறுக்கு நிறுவனம் , உயிரியல் உரிமம் விண்ணப்பம் , ஒன்றுபட்டது மாநிலங்களில் உணவு ,