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August 8, 2016

Kyowa Hakko Kirin Announced Kyowa Medex Acquired approval for Insurance Coverage of "25-Hydroxyvitamin D Assay"

Tokyo, Japan, August 8th 2016 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced that Kyowa Medex Co., Ltd. (CEO: Toshihiro Onodera, "Kyowa Medex") applied for insurance coverage of "25-hydroxyvitamin D" which is a measurement item for "Liaison® 25-Hydroxyvitamin D Total"1), an in vitro diagnostic ("IVD") reagent launched in December 2015 and eventually acquired approval for insurance coverage.

"Liaison 25-hydroxyvitamin D Total" is a DiaSorin S.p.A's2) product which was registered as an IVD on April 6th, 2015, by Kyowa Medex in Japan. The clinical indication of this product is to help diagnose the vitamin D deficient status among patients by measuring the total concentration of serum 25-hydroxyvitamin D2 and D3. (submitted for National Health Insurance points acquisition from Japanese government)

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.

Summary of Insurance Coverage for 25-Hydoxyvitamin D

Classification E3 (new item)
Measurement item 25-hydoxyvitamin D
Measurement method Chemiluminescent immunoassay
Main purpose for measurement Measurement of the concentration of serum 25-hydroxyvitamin D
(assistance for diagnosis of the vitamin D deficiency3))
Reimbursement points Four hundred (400)
Registration month of insurance coverage August, 2016
Consideration for reimbursement The reimbursement of the test should be applied only when it is conducted in diagnosis for rickets associated with the vitamin D deficiency and osteomalacia with its deficiency or during treatment for these diseases. However, the reimbursement is limited to once at the time of diagnosis, and afterward limited to once in three months.

1) "Liaison® 25-Hydroxyvitamin D Total"
"Liaison® 25-Hydroxyvitamin D Total" is a product of DiaSorin S.p.A which was registered in Japan as an IVD on April 6th, 2015, by Kyowa Medex Co., Ltd. The product works on the fully automated chemiluminescence analyzer, Liaison XL (released on July 7th, 2015) which the principle of chemiluminescence detection is applied to.

2) DiaSorin S.p.A
DiaSorin S.p.A is a worldwide developer, manufacturer, and marketer of IVDs, headquartered in Saluggia, Province of Vercelli, Piedmont Region, and Italy. The current CEO is Dr. Carlo Rosa. The consolidated revenue for 2015 was 499.2 million euros. For additional information, please refer to the company's website:New window opens . Kyowa Medex Co., Ltd. has entered into exclusive distribution agreement with DiaSorin S.p.A since 2006.

3) Vitamin D deficiency
Low concentration level of 25-hydroxyvitamin D which is an indicator reflecting vitamin D storage means Vitamin D deficient status in human. Vitamin D deficiency is defined as the deficient status accompanied by physical findings or abnormal images of a bone X-ray (Reference: "Guidance for diagnosis of vitamin D deficiency rickets and hypocalcemia", Japanese Society for Pediatric Endocrinology.)

[Liaison® 25-Hydroxyvitamin D Total] product image

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