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news.3SBio, a Chinese developer of biopharmaceutical products, has received approval from the Chinese State Food and Drug Administration (SFDA) for 36,000 IU dosage formulation of EPIAO.
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EPIAO is indicated as a treatment of chemotherapy-induced anemia.
The Phase III active controlled, multi center and randomized trial evaluated the efficacy and safety of a weekly subcutaneous injection of 36,000 IU EPIAO in oncology patients against a regimen of three times per week administration of 10,000 IU EPIAO.
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.
3SBio CEO Jing Lou said their new 36,000 IU formulation of EPIAO is the highest dose EPO formulation on the market in China, and EPIAO remains the only EPO product approved in 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," Lou said.