TOKYO - Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that its wholly owned subsidiary Chugai Pharma Science (Beijing) Co., Ltd. (Head Office, Beijing; President, Kosuke Mitsui) has obtained regulatory approval for eldecalcitol (product name: Edirol), an active vitamin D3 derivative created by Chugai from the China National Medical Products Administration (NMPA).

'I am glad that NMPA granted regulatory approval for Edirol as a therapeutic drug for osteoporosis,' said Dr. Osamu Okuda, Chugai's President and COO. 'Edirol is widely recognized as a base drug for the treatment of osteoporosis in Japan. We are working on preparation for the launch in China to contribute to osteoporosis treatment in the country.'

It is estimated that there are currently approximately 69 million osteoporosis patients in China. The objective of osteoporosis treatment is to maintain and improve patients' quality of life by preventing fracture associated disorders such as disorders of the locomotory apparatus and organ dysfunction, and bedridden status. Thus drugs that increase bone mass and reduce the risk of bone fractures are in great need.

About Edirol

Edirol is an active vitamin D3 derivative created by Chugai, which can improve calcium and bone metabolism. In Japan, Edirol was launched in April 2011 for the treatment of osteoporosis. In Prevention of Osteoporosis and Clinical Practice Guidelines 2015, Edirol is ranked as grade A as an active vitamin D3 preparation in the efficacy assessment to validate increase in bone mineral density and decrease in vertebral fracture.

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THE ASIA-PACIFIC REGIONAL AUDIT Epidemiology, cost & burden of osteoporosis in 2013 IOF

Contact:

Tomoko Shimizu

Tel: +81-3-3273-0881

Email: pr@chugai-pharm.co.jp

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