Gene Techno Science Co., Ltd. and Sanwa Kagaku Kenkyusho Co., Ltd. Announces Manufacturing and Marketing Approval for Darbepoetin Alpha Biosimilars in Japan
September 23, 2019 at 02:08 pm EDT
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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.
Kidswell Bio Corp, formerly Gene Techno Science Co Ltd, is a Japan-based company mainly engaged in the development of biopharmaceuticals. The biosimilar business is engaged in the research, development and provision of filgrastim biosimilar products and pegfilgrastim biosimilar products for cancer, darbepoetin alfa biosimilar products for renal diseases, and ranibizumab biosimilar products for eye diseases. The new biopharmaceutical business is engaged in the research and development of anti-RAMP2 antibodies for cancer and eye diseases, as well as new antibodies. The new biotechnology business is engaged in the development of regenerative medicine products that utilize intracardiac stem cells for pediatric congenital heart diseases, and regenerative medicine products that utilize dental pulp stem cells for cleft lip and palate and intestinal ganglion cell deficiency diseases, as well as the joint research business with universities.
Gene Techno Science Co., Ltd. and Sanwa Kagaku Kenkyusho Co., Ltd. Announces Manufacturing and Marketing Approval for Darbepoetin Alpha Biosimilars in Japan