Gene Techno Science Co., Ltd. and Sanwa Kagaku Kenkyusho Co., Ltd. has received manufacturing and marketing approval for darbepoetin alpha biosimilars (genetical recombination) from the Ministry of Health, Labor and Welfare effect on September 20, which has been jointly developed by both companies. GTS entered into an agreement with SKK for the joint development of darbepoetin alpha biosimilars on January 21, 2014 and have been proceeding with the development of biosimilar for darbepoetin alpha (genetical recombination), a long-acting erythropoiesis stimulating protein. Subsequently, based on the results of a phase III clinical study in Japan for the non-dialysis and dialysis patients of chronic kidney disease with nephrogenic anemia, SKK submitted a new drug application in September 2018 and received approval as the drug for nephrogenic anemia. SKK concluded a licensing agreement with Dong-A ST Co., Ltd. of South Korea for the development and commercialization of this drug in Japan.