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3SBio Inc. Announces SFDA Approval of High-Dose EPIAO
Date:7/11/2011

China for the treatment of chemotherapy-induced anemia. Less frequent injection provides chemotherapy patients and their physicians a new, safe and more convenient treatment option, encouraging the use of EPIAO in the under-penetrated oncology market.  High-dose EPIAO is a continuation of our strategy of seeking label extensions that differentiate our products from those of our competitors, helping to ensure that EPIAO remains the first choice for hospitals throughout China."

About the Phase III DataThe Phase III study was a multi-center, randomized, active-controlled trial that enrolled 206 non-myeloid malignant tumor patients. The testing group, including 104 patients, was given 36,000 IU EPIAO subcutaneously once a week for eight weeks. The control group, including 102 patients, was given 10,000 IU EPIAO three times a week for eight weeks. The primary endpoint of the study was the improvement of the hemoglobin level for > 1-2 g/dL compared to the baseline level. The trial result shows that 70% of patients on high-dose EPIAO injections had hemoglobin improvement of at least 1-2 g/dL from baseline level, similar to those receiving three times per week dosing of 10,000 IU EPIAO. In addition, the patients were assessed with the peak hemoglobin value, the nadir of hemoglobin value, the time it took for the hemoglobin level to increase for more than 1g/dL and 2g/dL, and the need for blood transfusion for each group. There was no significant difference between the two groups in these secondary endpoints.  

In addition, the safety of high-dose EPIAO was comparable to the 10,000 IU EPIAO. The most common adverse effect related to high-dose EPIAO was low fever. The patients recovered within a short period of time.

About 3SBio Inc.3SBio is a leading, fully integrated, profitable biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China. Its focus is on addressi
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