Green Cross Submits Biologics License Application to US FDA for IVIG-SN Submission Reinforces Commitment to Immune Therapy in the US marketplace

YONGIN, South Korea, Nov. 24, 2015 /CNW/ -- Green Cross Corporation (Green Cross), a South Korean biopharmaceutical company, today announced that it has submitted its Biologics License Application for IVIG-SN (human normal immunoglobulin G for intravenous administration) to the United States Food and Drug Administration (FDA). The application submitted for the treatment of primary immunodeficiency diseases (PID), a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system.

IVIG-SN demonstrated positive results in a Phase III study in patients with PID, meeting its primary endpoint of no acute serious bacterial infections. These results, included in the submission, were well under the requirement specified by the FDA guidance of no more than 1 acute serious bacterial infection per patient-year.

"The BLA submission for IVIG-SN marks a major step towards our ultimate goal of expanding biologics business to the US marketplace," said EC Huh, Ph. D., President of Green Cross Corporation. "The expected introduction of IVIG-SN will provide meaningful immune globulin product option for clinicians and their patients that further builds on the success already achieved with our products in other parts of the world."

Green Cross, the largest plasma protein products manufacturer in Asia, has been marketing IVIG-SN in more than 30 countries in Asia, South America and Middle East.

The FDA has a 60-day filing review period to determine whether Green Cross' Biologics License Application for IVIG-SN is complete and acceptable for filing.

About Green Cross Corporation

Green Cross Corporation (Green Cross) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in South Korea, Green Cross is the largest plasma protein product manufacturer in Asia and has been dedicated to quality healthcare solutions for nearly half a century.

This release includes forward-looking statements, which express the current beliefs and expectations of management. Such statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

SOURCE Green Cross

For further information: Hyun Goo Kang, Manager, Public Relations, Green Cross Holdings, +82-31-260-9382, gookang@greencross.com

Organization Profile

Green Cross

More on this organization


Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890