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3SBio Inc. Files for SFDA Approval of High-dose (36,000 IU) EPIAO
Date:9/25/2008

data which demonstrates that an once a week injection of 36,000 IU high-dose EPIAO is as effective as the three times per week 10,000 IU low-dose EPIAO in treating cancer patients with chemotherapy-induced anemia. If approved, high-dose EPIAO will provide patients and physicians in China with a new, safe and more convenient treatment of anemia resulting from chemotherapy. Furthermore, we believe that the greater convenience provided by high-dose EPIAO treatment versus existing treatment options will be a key factor in helping to fuel the growth of the highly under-penetrated oncology market in China."

About the Phase III Data

The 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 Inc. is a leading, fully integrated biotechnology company focused on researc
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SOURCE 3SBio Inc.
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