AFSTYLA, a hemophilia therapy developed by SK Chemicals SK케미칼이 jointly with multinational company CSL, has won approvals from major foreign governments, raising expectations whether the drug could emerge as a global product.

The new bio drug, which won approvals in the U.S., Europe, and Canada last year, has recently got the go-ahead from the Australian government, too. Similar processes are also under way in the Switzerland and Japan, industry sources said.

SK Chemicals developed the hemophilia treatment independently and exported the technology to CSL in 2009. It is a blood coagulation factor VIII with a single-chain product.

The current hemophilia therapies are taking the unified form of two separated proteins, but AFSTYLA is the whole combination of two proteins. The drug has been able to improve its safety from such a combination. And patients can continue to control bleeding by taking the drug twice a week.

CSL has been responsible for its production, global clinical trials, and application for approvals. SK Chemicals will get royalties and milestones generated from AFSTYLA’s sale, the revenue from which are likely to occur in earnest starting this year.

AFSTYLA won the U.S. approval last May and started its sale in July. Its sales in Canada and Europe will begin in earnest soon. As the drug got its sales approval from Australia recently, SK’s revenue from the new hemophilia drug will likely increase soon.

According to a 2015 report released by World Federation of Hemophilia_{세계혈우병재단}, 146 million International Unit (IU) of the factor VIII deficiency A hemophilia therapy are prescribed in Australia annually. And 95 percent of them were recombinant genetic therapies like AFSTYLA, whose average prices ranged from 2,570 to 5,140 won ($2.2~$4.5) per 10 IU

As the type A hemophilia treatment market, estimated at 8.2 trillion won a year, is also growing continually, Datamonitor predicted the market size would reach 9.5 trillion won in 2020, the market sources said.