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Simcere Pharmaceutical Group Successfully Completes Endostar Phase IV Clinical Study
Date:3/22/2010

Following changes in the Provisions for Drug Registration in China in 2005, Simcere invited Prof. Sun Yan from the Department of Medical Oncology at the Cancer Hospital of the Chinese Academy of Medical Sciences as Principal investigator, and the other 153 famous medical centers, to conduct a Phase IV clinical study for Endostar to further evaluate the safety and efficacy of this innovative new drug. The study was designed as an open label, prospective, and multi-center study and was the first Phase IV clinical study for a Class-1 new drug in China.

Endostar Phase IV clinical study passed the IRB/EC committee board of the Chinese Academy of Medical Science on November 10, 2006 and has taken two and half years to complete. Enrolment of the first patients commenced December 20, 2006, and the last patient was enrolled on June 10, 2009. In total, 2725 subjects were enrolled, which is the largest clinical study ever conducted in China. The survival analysis for stage statistics showed that Mean Survival Time (MST) was 17.57 months, 1-year survival rate was 63.68%, 2-year survival rate was 39.79%, and median Time to Tumor Progression (TTP) was 7.37 months. Objective Response Rate (ORR) was 23.93%, and Disease Control Rate (DCR) was 76.07%.

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SOURCE Simcere Pharmaceutical Group
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