SK Chemicals President Park Man-hoon.

SK Chemicals won permission from the U.S. Food and Drug Administration (FDA) to sell the hemophilia drug NBP601, which is a new bio-medicine it developed on its own. It’s the first time a Korean pharmaceutical company has obtained marketing approval of a generic recombination protein drug. The drug is called “Afstyla.” 

SK Chemicals announced on May 27 that the FDA gave the go-ahead for the marketing of the hemophilia A drug NBP601. The company licensed out the drug to Australian company CSL in 2009.

Hemophilia A is an inherited bleeding disorder caused by missing or defective factor VIII. Because of genetic defects and other factors, a blood coagulation factor is not created in the human body, which causes uncontrollable bleeding. Currently, hemophilia A occurs in approximately 1 in 5,000-10,000 males. 

The revenue of recombination products grew from $4.3 billion in 2011 to $4.9 billion in 2012, data from MRB Report and R&D Pipeline News.

SK Chemicals is in charge of marketing the new bio drug, while CSL is charged with technology transfer. 

CSL is a global pharmaceutical company that raked in $5.05 billion from 30 countries last year. CSL was the subject of global attention as the company acquired Novartis’s flu vaccine business.  

SK Chemicasl will receive royalties from CSL based on marketing volumes of the hemophilia A drug. 

“Investments into R&D for a long period of time have paid off,” said SK Chemicals President Park Man-hoon. 

SK Chemicals won permission from the U.S. Food and Drug Administration (FDA) to sell the hemophilia drug NBP601, developed on its own.(Photos:SK Chemicals)

SK Chemcals on a Roll

Sk Chemicals has come a long way in the pharmaceutical/bio industry. SK Chemical’s Sunpla, an anticancer drug, is Korea’s first homegrown drug. Joins is a new anti-arthritic drug developed by the Life Science R&D Center of SK Chemicals.

SK Chemicals is stepping up efforts to strengthen its presence in the vaccine business. SK Chemicals is developing market infrastructure and reinforcing its R&D efforts and resources to develop new vaccines and biomedicines. 

Medicine in the past used to focus almost exclusively on eliminating diseases, without much regard for the physical pain, complications, and side effects. Outgrowing this paradigm on medicine, SK Chemicals decided to develop and distribute vaccines that are the easiest and most economical way of preventing diseases. In partnership with multinational pharmaceutical giants, SK Chemicals has developed and launched 11 basic vaccines that are indispensable to public health. 

These include the mandatory vaccines for hepatitis B, chickenpox, diphtheria, tetanus, and pertussis (DTP), polio, measles, mumps, and rubella (MMR), tetanus and diphtheria (Td), and so forth, as well as the basic vaccines against meningitis and influenza.

Global pharmaceutical companies have taken notice of Korean counterparts’ recent rapid strides, business sources note. 

Hanmi Pharmaceutical Co. exported new drug technologies worth a combined 8 trillion won last year. Following Centrillion and Samsung BioEpis, which are accelerating efforts to make inroads into the global biosimilar market, SK Chemicals obtained permission to market the new drug in the United States.