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September 28, 2016

Application seeking Approval for Additional formulation of ACOALAN® in Japan

Tokyo, Japan, September 28th, 2016 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has filed an application to Japan's Ministry of Health, Labor and Welfare (MHLW) seeking for manufacturing and marketing approval for an additional formulation, the 1800IU vial of ACOALAN® injection (Generic Name: Antithrombin gamma, "ACOALAN®").

ACOALAN® contains a recombinant Antithrombin (AT), which inhibits blood coagulation. ACOALAN® was approved on July 3rd, 2015 for thrombophilia due to congenital AT deficiency (CAD) and disseminated intravascular coagulation (DIC).

This additional approval will enable expansion of the ACOALAN® line-up, which at present includes only the 600IU vial. At the same time as the application for approval, we filed an application for a partial amendment to the manufacturing and marketing approval of ACOALAN®; specifically, we are seeking to change the storage temperature from refrigerated to room temperature, as other AT drugs.

"We are pleased to announce this application for additional approval," said Masashi Miyamoto, Executive officer and Director of the Strategic Product Portfolio Department. "We believe that the partial change and the addition of the 1800IU vial for ACOALAN® will help healthcare providers by reducing operational burdens."

Kyowa Hakko Kirin and the Japan Blood Products Organization (head office: Tokyo, Japan, President and representative director: Takahide Ishikawa, "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, a serine protease inhibitor, 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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