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Biz News Korea(Eng)
Korea’s SK Chemical hemophilia drug approved in U.S.
- Collected
- 2016.05.28
- Distributed
- 2016.05.30
- Source
- Go Direct
The drug branded as Afstyla became the first FDA-approved biologic drug developed by a Korean company, SK Chemical said. The company would be paid an undisclosed sum of royalties by its Australian partner on the successful regulatory approval. The company’s stock closed Friday at 78,100 won ($66.24), up 5.7 percent from the previous day.
Afstyla is a type A hemophilia treatment. Patients with hemophilia have a congenital problem in blood coagulation affecting their muscles, joints and internal organs. Most patients are male.
According to market research company Data Monitor, the market of type A hemophilia drugs in the U.S. was valued at $3 billion in 2014.
The market is dominated by Baxalta, a global biopharmaceutical company dedicated to developing drugs to treat rare and refractory disease. The company was recently acquired by Irish drug maker Shire. Baxalta is followed by Spanish pharmaceutical company Grifols and CSL.
SK Chemical’s new drug is more effective and longer acting than existing hemophilia drugs. A global clinical trial demonstrated the drug’s efficacy with a twice-weekly schedule, more convenient than drugs that should be injected three or four times a week.
Exports of the drug to the U.S. and other major markets are closer to being realized. The drug is under the final approval process in Europe and Australia.
“Afstyla will likely be launched in the U.S. next year and SK Chemical may receive 5 percent of gross sales as a royalty,” said Lee Seung-ho, an analyst at NH Investment & Securities.
By Lee Dong-in
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