SK Chemicals Co., the chemical and pharmaceutical arm of South Korea's conglomerate SK Group, said Friday it has won approval from the U.S. Food and Drug Administration to sell its hemophilia drug, taking a step closer toward commercializing the homegrown drug in the global market.
The "NBP601," which was developed by SK Chemicals and licensed out to Australia's biotechnology firm CSL Ltd. in 2009, is a recombinant DNA biologic drug to treat the rare bleeding disorder.
SK Chemicals forecast that FDA approval of the drug, named Afstyla, will allow the drug firm to make inroads into the lucrative market.
"We have finally come to fruition after investing in research and development (R&D) for a long time," said CEO Park Man-hoon, adding that the approval will act as a driving force in commercializing the product in the global market.
The U.S. hemophilia A market is worth $3 billion in 2014, taking more than 40 percent of the global market estimated at $7.1 billion, according to data by research firm Datamonitor.
Datamonitor further forecast the lucrative U.S. market to expand over the next few years by 33 percent to reach $4.1 billion in 2023.
SK Chemicals said patients need to take Afstyla only two times a week, while they previously required three to four injections or blood transfusions.
The rare disease occurs when the blood does not clot normally due to the lack of certain proteins. The disorder is mostly found among males at birth. (Yonhap)