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August 16, 2018

GC Pharma’s intravenous immunoglobulin drug pending US approval

PUBLISHED : February 12, 2018 - 15:46

UPDATED : February 13, 2018 - 15:47

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[THE INVESTOR] GC Pharma, formerly Green Cross, is expected to launch its immunodeficiency drug candidate in the US as early as this year as it is pending approval from the local health authorities, an analyst here said on Feb. 12.

The drug UVIG-SN, human normal immunoglobulin G for intravenous administration, is currently under review by the US Food and Drug Administration after a delay due to manufacturing issues raised during the regulator’s inspection. 

“IVIG-SN is likely to obtain the FDA approval in the second half of this year. The intravenous immunoglobulin market is growing at about 7-8 percent per year and use of the treatment is expanding from advanced countries to emerging nations,” said Hi Investment & Securities analyst Huh Hye-min.

The company is fully preparing for the US launch, what CEO Huh Eun-chul once called “the biggest event of this year.”

In October, the Yongin-based firm completed the construction of its US$200 million biopharmaceutical plant in Canada, which is capable of producing 1 million liters of plasma protein products. It also set up a US entity GC Mogam to manage the sales of IVIG-SN.


By Park Han-na (hnpark@heraldcorp.com

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