3SBio Inc (SSRX)

[surf1944]

1:39AM 3SBIO receives SFDA approval of High-Dose EPIAO (SSRX) 17.86 : Co announces that the Chinese State Food and Drug Administration has approved its 36,000 IU dosage formulation of EPIAO for the treatment of anemia associated with chemotherapy in cancer patients. High-dose EPIAO is the only dosage form of this kind available in China. The clinical trial examined the safety and efficacy of a weekly subcutaneous injection of 36,000 IU EPIAO in oncology patients compared with a regimen of three times per week administration of 10,000 IU EPIAO. The results showed that 70% of the patients receiving high-dose EPIAO injections had hemoglobin improvement of 1-2 g/dL from baseline, similar to those receiving three times per week dosing of 10,000 IU EPIAO. More importantly, the weekly administration of 36,000 IU EPIAO demonstrated equivalent safety and tolerability profiles as the three times per week 10,000 IU EPIAO.