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JR-131, long-acting erythropoiesis-stimulating agent, demonstrates equivalence in phase III study


Wednesday, 17 Jan 2018 

Jan 17 (Reuters) - Kissei Pharmaceutical Co Ltd <4547.T>:Says it and JCR Pharmaceuticals Co Ltd <<<4552.T>>> jointly announced positive results of the phase III study for JR-131, a proposed biosimilar to darbepoetin alfa, a long-acting erythropoiesis-stimulating agent for the treatment of renal anemia .In the Phase III study initiated in August 2016, JR-131 demonstrated equivalence in efficacy and safety compared with darbepoetin.Accordingly, in a primary endpoint of efficacy, the equivalence was verified for variations in hemoglobin concentration and the similarity with regard to the safety profile was confirmed . 

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