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December 10, 2018

Chong Kun Dang seeks biosimilar approval in Japan

PUBLISHED : October 05, 2018 - 15:57

UPDATED : October 05, 2018 - 15:57

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[THE INVESTOR] Korean drug firm Chong Kun Dang Pharmaceutical said on Oct. 5 that it sought approval for sales of its anemia biosimilar in Japan from health authorities there earlier this week.

In April, the Korean company signed a deal with the Japanese unit of an American pharmaceutical firm to export CKD-11101, a biosimilar version of the novel erythropoiesis stimulating protein that treats anemia in patients with chronic renal insufficiency.

Chong Kun Dang declined to identify the American firm, citing a confidentiality agreement.

The firm said it can export CKD-11101 to the Japanese unit if approved by the Japanese Ministry of Health, Labor and Welfare. The Japanese unit will be responsible for sales of the anemia biosimilar to consumers.

CKD-11101 references the red blood cell booster NESP, originally developed by Japanese pharmaceutical firm Kyowa Hakko Kirin.

By Song Seung-hyun and newswires (ssh@heraldcorp.com)

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