August 9, 2016

Kissei and JCR to Initiate a Phase III Clinical Trial of a Long-Acting Erythropoiesis-Stimulating Agent (Development Code: JR-131)


Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto-city, Nagano; Chairman and CEO: Mutsuo Kanzawa) ("Kissei") and JCR Pharmaceuticals Co., Ltd. (Headquarters: Ashiya, Hyogo; Chairman and President Shin Ashida) ("JCR") jointly announced the initiation of a Phase III clinical trial of JR-131, a biosimilar for a long-acting erythropoiesis-stimulating agent, darbepoetin alfa (generic name) for the treatment of renal anemia.

The companies have been conducting research and development activities since the conclusion of a collaborative research and development agreement for JR-131 in September 2013. The equivalence of pharmacokinetics has been verified and the safety has been confirmed in the Phase I clinical trial, thus a Phase III clinical trial is to be initiated.

The companies both aim to contribute to the improvement of medical treatment for renal anemia through development of the economically efficient JR-131 and provision of this new treatment option, by leveraging JCR's know-how and expertise in biopharmaceutical manufacturing that meets the global quality standards, Kissei's established presence in the dialysis field, and the accumulated results of the first domestic biosimilar ever made in Japan, "Epoetin alfa BS injection [JCR]".