Saturday, June 30, 2012

SFDA approves 3SBio's application for China arm of Phase III voclosporin trial

PBR Staff Writer Published 29 June 2012

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.

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.

Source: http://clinicaltrials.pharmaceutical-business-review.com/news/sfda-approves-3sbios-application-for-china-arm-of-phase-iii-voclosporin-trial-290612

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