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July 3, 2015

Approval for ACOALAN® in Japan

Tokyo, Japan, July 3, 2015 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has received approval for thrombophilia due to congenital antithrombin (AT) deficiency (CAD) and disseminated intravascular coagulation (DIC) accompanied by a decrease in AT of recombinant human AT preparation ACOALAN® injection (code name: KW-3357, here in after ACOALAN®) [generic name: Antithrombin Gamma (Genetical Recombination)] by the Ministry of Health, Labour and Welfare.

ACOALAN® is a preparation containing a recombinant AT that has the identical amino acid sequence of human plasma derived AT and the similar sugar chain profile. AT inhibits coagulant action by forming a complex with the protease involved in blood coagulation. Since ACOALAN® is a recombinant AT preparation, it is expected that the infection risk resulting from human blood will be avoided.

Kyowa Hakko Kirin and the Japan Blood Products Organization (head office: Tokyo, Japan, President and representative director: Yuuji Akiyama, "JB") have signed an outsourcing agreement concerning domestic sales of ACOALAN®.JB will be responsible for selling ACOALAN® and providing information to medical institutions.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

About Antithrombin (AT)
AT is a serine protease inhibitor, which is a single chain glycoprotein with a molecular weight of about 60,000 produced by liver and vascular endothelial cell. AT binds to blood coagulation factors such as thrombin and activated forms of Factor X, which are serine proteases, and inhibits blood coagulation.

About Congenital Antithrombin Deficiency (CAD)
CAD is a genetic disorder characterized by iterative thrombosis. Continued AT deficiency results in a decrease in anticoagulant activity, and minor factors that normally would not lead to thrombus formation can result in thrombosis.

About Disseminated Intravascular Coagulation (DIC)
DIC may be observed as a disorder that accompanies cancer, serious infections such as septicemia, leukemia, malignant lymphoma, placental abruption and so forth. When a person has DIC, blood clots are formed more easily in the capillaries around the body and results in clots that obstruct blood circulation in organs such as the kidneys, liver, and brain, which then causes disorders in the affected organs. If many clots form, platelets and coagulant factors are spent not to form new clots for hemostasis. The reactions to dissolve clots get to be enhanced for the multiple clots at the same time. These things result in bleeding.

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