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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. ....
Press release content from Business Wire. The AP news staff was not involved in its creation. GC Pharma Reports Full Year 2020 Results February 9, 2021 GMT YONGIN, South Korea (BUSINESS WIRE) Feb 9, 2021 GC Pharma (formerly known as Green Cross Corporation) (KRX: 006280), a South Korean biopharmaceutical company, today announced unaudited financial results for the year ended 31 December 2019. Key Figures (1) - (1) Results from continuing operations (Green Cross MS’ blood bag business has been classified as discontinued operations) (2) Results and percentages compare full financial year 2019 Financial Highlights Delivered total revenue growth of 10.8% to KRW 1,504.1 billion (2019: 1,357.1 billion), and operation profit increased 20.6% to KRW 50.2 billion (2019: 41.7 billion) in the full year of 2020 ....