3SBio Files for Approval of Anemia Treatment

3SBio Inc. (SSRX) has filed for SFDA approval of a high-dose, 36,000 IU formulation of EPIAO for the treatment of anemia resulting from chemotherapy. Unlike 3SBio’s other formulations of EPO, this one would be exclusive to the company. A 36,000 IU injection would be administered once every week, a significant advantage over the three-times per week administration of the more common 10,000 IU injections.

In its clinical trial, the high-dose EPIAO performed at about the same levels as the low-dose formulation. In both cases, 70% of the patients experienced hemoglobin improvement of 1-2 g/dL from baseline. Safety and tolerability profiles were also similar. A low grade fever, which disappeared in time, was the major complaint.

The Phase III trial enrolled 206 non-myeloid malignant tumor patients who were split into two groups: the once-per week high-dose 36,000 IU patients, and the three-times-per-week 10,000 IU patients. The trial also compared peak Hemoglobin value, nadir Hemoglobin value and the time required for the Hemoglobin value to increase more than 1 g/dL and 2 g/dL. There was no significant difference between the two groups on these secondary endpoints.

Disclosure: None.