3SBio Files Registrational Trial Application For Feraheme In China

3SBio, a company focused on research, development, manufacturing and marketing of biopharmaceutical products primarily in China, has submitted its application for a registrational clinical trial to the Chinese State Food and Drug Administration (SFDA) for Feraheme (ferumoxytol) injection, for intravenous use.

Feraheme is an intravenous iron therapy that 3SBio licensed from Amag Pharmaceuticals, for development in China, for the treatment of anemia in adult patients with chronic kidney disease (CKD).

Feraheme was approved on June 30, 2009 by the FDA for the same indication for which 3SBio is seeking approval in China and was launched commercially in the US by Amag in July 2009. As previously announced, 3SBio has exclusive rights to develop and commercialize Feraheme in China. Once approved by the SFDA, 3SBio will start a multi-center randomized efficacy and safety study in China with approximately 200 CKD patients, measuring the mean change in hemoglobin from baseline at day 35 after first dose.

Jing Lou, chief executive officer of 3SBio, said: “We are pleased with the timely submission of the Feraheme clinical trial application to the SFDA in China, representing a major milestone and our commitment to bringing this innovative therapy to Chinese CKD patients in need. We look forward to working with the SFDA to ensure an efficient review process.”

Brian Pereira, president and chief executive officer of Amag Pharmaceuticals, said: “3SBio is the ideal partner to bring Feraheme to iron deficiency anemia patients with chronic kidney disease in China. This step represents an important milestone in our efforts to broaden the global reach of Feraheme.”