Summary :
GC Pharma (KRX:006280) today 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 Q4 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.
“We will continue to communicate with the FDA to coordinate the required onsite inspection as soon as possible.” said EC Huh, Ph.D, President of GC Pharma.
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 globally 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.
This press release may contain forward-looking statements, which express the current beliefs and expectations of GC Pharma’s management. Such statements do not represent any guarantee by GC Pharma or its management of future performance and involve known and unknown risks, uncertainties and other factors. GC Pharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule.