29 June 2012 | Regulatory | By BioSpectrum Bureau
3SBio to join global ph III trial for Voclosporin
This will be a phase III, randomized, multi-center, concentration-controlled comparison study on renal transplant patients
Singapore: 3SBio, a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, has received State Food and Drug Administration (SFDA) approval to conduct the China arm of the multi-center phase III trial of voclosporin, a new generation calcineurin inhibitor licensed from Japan's Isotechnika Pharma.
According to the approved protocol, this will be a phase III, randomized, multi-center, concentration-controlled comparison study on renal transplant patients. Patient enrollment is expected to begin in the third quarter of 2012.