Kissei Pharmaceutical Co., Ltd. (Chairman and CEO: Mutsuo Kanzawa) ('Kissei') and JCR Pharmaceuticals Co., Ltd. (Chairman and President: Shin Ashida) ('JCR') 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.
Kissei and JCR concluded a collaborative research and development agreement for JR-131 in September 2013, and have been advancing the development with the aim to apply for marketing approval in 2018. JR-131 which offers economic efficiency, can become a new treatment option in the renal diseases areas. Both companies are aiming to contribute to healthcare through the development of JR-131, by leveraging JCR's strong know-how and expertise in biopharmaceutical manufacturing that meets the global quality standards, and Kissei's outstanding performance in the renal diseases including dialysis areas and sales results of the first biosimilar in Japan, 'Epoetin alfa BS Injection [JCR]'.
Kissei Pharmaceutical Co. Ltd. published this content on 17 January 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 17 January 2018 06:09:07 UTC.
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KISSEI PHARMACEUTICAL CO.,LTD. is a Japan-based company mainly engaged in the manufacture and sale of pharmaceutical products. The Company is engaged in the collection and analysis of medicine development information, and the manufacture and sale of medicines. It is also engaged in the purchase and sale of related materials, system development and information process work, construction contract work such as new construction, expansion and renovation of factories, laboratories and offices, the management of facility and equipment work, information collection and development support work, noodle manufacture and sale, and insurance agency business.
KISSEI PHARMACEUTICAL CO., LTD. 
