SHENYANG, China, July 11, 2011 /PRNewswire-Asia-FirstCall/ -- 3SBio Inc. (NASDAQ: SSRX) ("3SBio" or "the Company"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that the Chinese State Food and Drug Administration ("SFDA") 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 approval provides patients in China with an additional treatment option which has been available since 2004 in the United States and 2006 in the United Kingdom.
High-dose EPIAO is designed for the rapid restoration of hemoglobin to normal levels among cancer patients. The 36,000 IU dosage is comparable to the standardized dose used globally for chemotherapy-induced anemia, allowing for less frequent administration than lower dosage forms, which in turn is expected to provide greater convenience for both patients and caregivers.
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.
Commenting on the news, Dr. Jing Lou, chief executive officer of 3SBio, said: "Our 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
|SOURCE 3SBio Inc.|
Copyright©2010 PR Newswire.
All rights reserved