Korea’s CJ HealthCare said on Sept. 28 it has signed a license deal with Tokyo-based biopharmaceutical firm YL Biologics to export its biosimilar version of Amgen’s anemia drug Aranesp.
The license grants YL Biologics and its parent firm Yoshindo rights to use the drug candidate CJ-40001 for clinical trials, regulatory approval, manufacturing and sales in Japan. The Korean drug maker will support the Japanese counterpart for marketing authorization.
Under the deal, CJ HealthCare is eligible for milestone payments, as well as tiered royalties. The companies didn’t disclose the total amount.
CJ-40001 is a copycat version of the red blood cell booster Aranesp, which is sold as Nesp in some Asian countries, co-developed with Japan’s Kyowa Hakko Kirin and US-based Amgen. The drug raked in US$2.1 billion in 2016.
The biosimilar candidate is the second generation of erythropoietin, also known as EPO, an important hormone produced by the kidney that is critical in the formation of red blood cells by the bone marrow.
“The license deal enables CJ HealthCare to enter Japan’s second generation EPO Nesp market worth 600 billion won,” the firm said.
While the first generation of EPO is required to be administrated three times a week, the frequency of CJ-40001 administration is expected to be reduced to once every two weeks, according to the firm.
In Korea, the ministry of Food and Drug Safety gave the green light to CJ HealthCare to enter phase 3 clinical studies of CJ-40001 in February. Along with CJ HealthCare, two other Korean drug makers -- Chong Kun Dang and Dong A-ST -- are pushing for developing their own versions of the anemia treatment.
Chong Kun Dang’s CKD-11101 is in phase 3 clinical trials which the company plans to complete this year. In 2016, the firm signed a deal with Japan’s Fuji Pharma to license out marketing rights of the candidate drug. Dong A-ST signed a licensing-out agreement for its Aranesp alternative DA-3880, under phase 3 clinical study in Japan, with Sanwa Kagaku Kenkyusho in 2014.
By Park Han-na (email@example.com