Chong Kun Dang Pharmaceutical Corp. (CKD) announced on Dec. 2 that it has recently received sales approval for its second-generation anemia biosimilar ”CKD-11101" from the Ministry of Food and Drug Safety of South Korea. CKD-11101 is the first biosimilar version of novel erythropoiesis stimulating protein (NESP) in the world and the first bio medicine of the company.
With the latest approval, CKD-11101 has become the world's first NESP biosimilar to be licensed for sale. NESP is a second-generation anemia drug developed by Japan’s Kyowa Hakko Kirin Co. after introducing the technology of U.S.-based pharmaceutical firm Amgen Inc. It treats anemia in patients with chronic renal insufficiency and those undergo chemotherapy for solid cancer. Compared to the first-generation treatment “Epogen,” its injection cycle has been extended by three times.
The global sales of NESP come to 3 trillion won (US$2.67 billion) a year. This is why not only domestic but also global leading pharmaceutical companies have been pushing to develop biosimilars to NESP. In addition to CKD, Dong-A ST Co. and CJ HealthCare Corp. have also been developing biosimilars in South Korea.
CKD-11101 has dramatically reduced the frequency of administration by making use of the generic engineering technology, improving patients’ convenience. CKD has been developing CKD-11101 after it secured the raw material manufacturing technology in 2008 and established a manufacturing plant in 2012. The company verified the safety of its new drug in the phase 1 clinical trial and proved its safety and efficacy in regards to the original medication through the phase 3 clinical trial carried out last year.
With the latest sales license, CKD is able to jump into the global bio medicine market. CKD-11101 is the first bio medicine of the company. CKD is planning to start selling CKD-11101 in the domestic market within 2019.
The company will also step up its efforts to penetrate the global medicine market. CKD exported CKD-11101 to a pharmaceutical firm in Japan, the country from which NESP has originated. NESP posts 500 billion won (US$445.63 million) in sales a year. The company applied for approval for manufacturing and sales of its anemia biosimilar from the Japanese Ministry of Health, Labor and Welfare in October and the drug is currently under review. CKD is also planning to get a patent in the U.S. and Europe and push into the markets.