The China State Food and Drug Administration (SFDA) has approved 3SBio's application to conduct the China arm of the multi-center Phase III trial of voclosporin.
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Voclosporin is a new generation calcineurin inhibitor licensed from Isotechnika Pharma.
According to the approved protocol, the study will be a Phase III, randomized, multi-center, concentration-controlled comparison study on renal transplant patients.
The company expects to begin patient enrollment in the third quarter of 2012.
3SBio is a biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China.