3SBio to join global ph III trial for Voclosporin

Updated on 29 June 2012

It has received the state Food and Drug Administration's approval to conduct the China arm of the multi-center phase III trial of voclosporin

sfda-approval

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.

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