April 25, 2024

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[THE INVESTOR] CJ HealthCare, the pharmaceutical arm of CJ Group, has moved closer to launching a biosimilar version of Amgen’s anemia drug Aranesp as South Korean health authorities approved its late-stage clinical trial plans this week.

The Ministry of Food and Drug Safety on Feb. 27 gave the green light to CJ HealthCare to enter phase 3 clinical studies on CJ-40001, a copycat of the red blood cell booster darbepoetin alfa, co-developed with Japan’s Kyowa Hakko Kirin and US Amgen.

“We expect to commercialize the biosimilar here in 2019. When developing a drug candidate, we are always considering possible entry into the US or European markets. The product is not an exception,” an official at CJ HealthCare told The Investor.

Aranesp is one of anemia drugs built Amgen into the world’s biggest biotechnology company.

Along with CJ HealthCare, other two Korean drug makers are also 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 within this year. Last year, the firm signed a deal with Japanese pharmaceutical company Fuji Pharma to license out the marketing rights of the candidate drug.

Dong A-ST also signed a licensing-out agreement on its Aranesp alternative DA-3880, under phase 3 clinical study in Japan, with Sanwa Kagaku Kenkyusho in 2014.

As the three therapies are designed to work in the same way, Amgen’s anemia drugs, lagging behind the two rivals in development schedule is critical for CJ HealthCare.

“It’s going to be a matter of who’s going to reach an agreement with global pharma firms in US and Europe,” a CJ HealthCare official said.

To defend its turf from biosimilar makers, the originator Kyowa Hakko Kirin said earlier this year that it has set up a subsidiary to sell a new version of Aranesp which has been launched in a number of Asian countries under the brand name Nesp.

By Park Han-na (hnpark@heraldcorp.com)