Green Cross will soon be ready to make its full-fledged debut in the US market, with the aim of taking a share of the world’s largest pharmaceuticals market.
The Korean biopharmaceuticals company is expected to win the US Food and Drug Administration’s approval for its immunodeficiency drug IVIG-SN -- human normal immunoglobulin G for intravenous administration -- within this year, according to the firm and analysts.
IVIG-SN, exclusively developed by Green Cross, treats primary immunodeficiency disorders that weaken or strip the immune system’s ability to fight infectious diseases.
Green Cross’ immunodeficiency drug IVIG-SN (Green Cross)
Green Cross plans to submit supplementary data regarding IVIG-SN to the FDA in September. It had submitted its biologics license application in 2015 and was asked to submit supplementary data in 2016.
The firm’s president, Huh Eun-chul, showed strong willingness to penetrate the US market, saying in an interview with a local media outlet early this year, “We cannot become a global company without making a debut in the US market. What we mean by ‘global’ is that more than half of the firm’s sales come from the (overseas) market.”
The US is currently the largest and the most lucrative market for IVIG-SN. It generates 7 trillion won ($6.1 billion) in sales, accounting for around 40 percent in the global market, according to HMC Investment Securities.
Also, immunodeficiency drugs are sold for a price around four times higher in the US than in Korea due to different medical laws, according to Green Cross.
“When the IVIG-SN drug is approved without issue in the US this year, it will generate $20 billion in sales to Green Cross next year,” said Lee Hye-rin, an analyst at KTB Investment & Securities.
Market tracker FnGuide estimated that sales and operating profits of Green Cross will rise 6.7 percent and 18.1 percent respectively in 2018 on-year.
By Shin Ji-hye (shinjh@heraldcorp.com)