JW Pharmaceutical said Sunday that it had gained approval from the South Korean drug regulator for domestic sales of hemophilia antibody Hemlibra, developed by Chugai.
Chugai is a member of the Roche Group, after merging with Nippon Roche in 2002 in a “strategic alliance.” Hemlibra was created by Chugai and co-developed globally by Chugai, Roche and Genentech.
JW Pharmaceutical secured the exclusive license for Hemlibra sales in Korea in 2017.
Hemlibra, a subcutaneous injectable drug that can treat hemophilia in a patient with a once-a-week self-injection, was approved by the US Food and Drug Administration and Europe’s European Medicines Agency in November 2017 and February 2018, respectively.
Hemlibra is the first, and so far the only, subcutaneous injection for patients with hemophilia A with or without FVIII inhibitors.
Hemophilia is a rare disorder in which a person’s blood doesn’t clot normally due to the lack of a clotting protein called factor VIII. The disorder affects around 320,000 people worldwide, according to the World Federation of Hemophilia’s data dated 2012.
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 analyzers predict 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 (firstname.lastname@example.org)