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3SBio Inc. Receives SFDA Approval for TPIAO Label Extension for the Treatment of ITP
Date:1/24/2011

mulating the TPO receptor, which is intended to have the effect of directly increasing platelet production to outpace platelet destruction by the immune system. The registration trial examined the safety and efficacy of a 14-day subcutaneous injection of TPIAO on ITP patients who are resistant to steroid treatment, followed by a 14-day observation period. The results showed an overall patient response rate to TPIAO treatment of 60.27%, significantly higher than the Danazol control group response rate of 36.51%. Patients administered TPIAO also reached effective platelet counts in 7 days, compared to 10 days for patients within the control group.

About the Phase III StudyThe Phase III study that 3SBio conducted was a multi-center, randomized, placebo-controlled study in ITP patients who failed to respond to glucocorticoid treatment. All patients were administered Danazol, a synthetic steroid hormone drug routinely used to treat ITP. The treatment group was administered an additional 1.0 microgram/kg TPIAO subcutaneously daily for 14 days. The primary endpoint of the trial was the measurement of effective platelet counts, in which maximum counts reached >50x109/L or increased >30x109/L over the baseline, during the 14-day treatment.

The results of the Phase III study demonstrated TPIAO to be an effective treatment for ITP with tolerable mild adverse effects. The overall response rate in the treatment group and the control group was 60.27% and 36.51%, respectively (p=0.0104). The platelet response time, characterized by the time required for platelet counts to reach >50x109/L or increase >30x109/L over the baseline, for the first 25% of patients in the TPIAO treatment and control group was 7 and 10 days, respectively. A 14-day TPIAO treatment was subsequently applied to patients in the control group whose platelet counts remained < 20x109/L. The overall response rate to the TPIAO treatment was 67%. The overall adverse events rate in the
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