Isotechnika Pharma Inc. announced that 3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, has received approval from the State Food and Drug Administration (SFDA) to conduct a multi-center Phase 3 trial of voclosporin in China.
According to the approved protocol, this will be a Phase 3, randomized, multi-center, concentration-controlled and comparison study in kidney transplant patients. Patient enrollment is expected to begin in Q3 2012.
In 2010, Isotechnika granted 3SBio exclusive rights to all transplant and autoimmune indications of voclosporin in China, including Hong Kong and Taiwan, excluding ophthalmic indications and medical devices. 3SBio is responsible for the clinical development, registration and commercialization of voclosporin in China. Isotechnika will receive ongoing royalties based on sales of voclosporin by 3SBio.
Date: June 28, 2012
Source: Isotechnika Pharma Inc.