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June 27, 2013

Kyowa Hakko Kirin Submits Application for Approval in Japan for Sustained-Duration G-CSF Product (KRN125)

Tokyo, Japan, June 27, 2013 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has filed an application for marketing approval to the Ministry of Health, Labour and Welfare (MHLW) for sustained-duration G-CSF product KRN125 (generic name: pegfilgrastim) which is currently undergoing development for the treatment of chemotherapy-induced febrile neutropenia.

KRN125 is a sustained-duration PEGylated form of a filgrastim, one of a Granulocyte Colony-Stimulating Factor (G-CSF) product, for the treatment of chemotherapy-induced neutropenia. While GRAN® requires repeated daily doses over several days, KRN125 shows comparable efficacy with a single dose per chemotherapy cycle. KRN125 is therefore expected to reduce the burden of frequent hospital visits of outpatients undergoing chemotherapy. Also, prophylactic administration of KRN125 prior to the episode of neutropenia reduces the risk of infection, which results in clinical benefits such as improving the compliance with doses and schedules of chemotherapy.

Kyowa Hakko Kirin made an application for marketing approval based on the results of domestic clinical trials of KRN125, which demonstrated its efficacy and safety for chemotherapy-induced febrile neutropenia.

Pegfilgrastim was originally generated by Amgen, Inc., and licensed from Kirin-Amgen Inc., to Kyowa Hakko Kirin. It has already been approved in 105 countries and regions around the world.

Kyowa Hakko Kirin is focusing on the oncology area, along with three other focused areas as our category-based strategy. Kyowa Hakko Kirin is expecting to contribute to the treatment of cancer patients through the approval of drugs in accordance with medical needs.

About chemotherapy-induced febrile neutropenia
Febrile neutropenia means that there is an abnormally low level of infection-fighting white blood cells (neutrophils) in the body and a condition of continuous fever, and it is suspected infection in patients under chemotherapy.

About Granulocyte Colony-Stimulating Factor (G-CSF) product
G-CSF, a protein produced using gene recombination. The G-CSF selectively stimulates the production of neutrophils and also further enhances the neutrophil function. Based on this mechanism, the G-CSF is used to accelerate recovery from chemotherapy-induced neutropenia, and it reduces various risks associated with neutropenia.

About PEGylation
PEGylation is the chemical binding of polyethylene glycol to the objective protein. When protein undergoes PEGylation, it enables to suppress degradation and reduce clearance of the protein, resulting to improve drug retention in the blood and prolong drug action.

About Kirin-Amgen Inc.
A joint-venture between Kirin Holdings and Amgen.

About category-based strategy
Each category (Nephrology; Oncology; Immunology and allergy; and Central Nervous System) will have its own portfolio management from R&D through to sales. We will achieve sustained growth while striving to improve productivity.

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