Chugai News Releases are issued to provide stakeholders with the most up-to-date information related to our company. In some instances, information on products or drug candidates under development may be included, but this is intended for members of the media, shareholders, and investors. The information is not intended for promotional or advertising purposes, or as medical advice, etc.

Dec 18, 2020

Chugai's Osteoporosis Agent Edirol Obtains Regulatory Approval in China

  • Edirol has been approved for the treatment of osteoporosis in China following Japan.

TOKYO, December 18, 2020 -- 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.

Trademarks used or mentioned in this release are protected by law.

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


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