JW Pharmaceutical said Sunday that it had gained the South Korean drug regulator’s nod to begin domestic sales of the hemophilia treatment Hemlibra, developed by Chugai, a Roche-owned company.

JW Pharmaceutical obtained an exclusive license to sell Hemlibra on the Korean market in 2017.

The Ministry of Food and Drug Safety has now approved the antibody for the treatment of patients with hemophilia A, with or without factor VIII inhibitors.



Hemlibra is the first, and so far the only, subcutaneous injection treatment for hemophilia A, a rare disorder in which a person’s blood doesn’t clot normally due to the lack of a protein called factor VIII. The disorder affects around 320,000 people worldwide, according to 2012 data from the World Federation of Hemophilia.

People with hemophilia can self-administer Hemlibra once a week. It was approved by the US Food and Drug Administration in November 2017 and by Europe’s European Medicines Agency in February 2018.

Hemlibra was created by Chugai and co-developed globally by Chugai, Roche and Genentech. Chugai is a member of the Roche Group, having merged with Nippon Roche in 2002 in a “strategic alliance.”

JW Pharmaceuticals will begin sales of Hemlibra in Korea after negotiating pricing with the nation’s Health Insurance Review and Assessment Service.

Global pharmaceutical market analysts predict that Hemlibra will bring in 5 trillion won ($4.4 billion) in annual sales in the global hemophilia market. The domestic market volume for the disease segment is estimated at 150 billion won, according to HIRAS.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)