3SBIO Files for Approval on Three New Drugs

3SBio Inc. (NSDQ: SSRX) has filed for SFDA approval of a biologic drug, recombinant human thrombopoietin, known as TPIAO, as a treatment of idiopathic thrombocytopenic purpura (ITP). TPIAO has been marketed since 2006 for treatment of chemotherapy-induced thrombocytopenia, or platelet deficiency.

In ITP, the body perceives its platelets as foreign and the immune system attempts to destroy them, leaving patients with dangerously low platelet counts. More than half of China’s 80,000 ITP patients do not respond to conventional steroid treatment. TPIAO stimulates the TPO receptor, which increases platelet production, a different mechanism than steroids.

The Phase III trial enrolled ITP patients who were resistant to steroids. They were administered a 14-day subcutaneous injection of TPIAO in addition to steroids. A 14-day observation period followed. The response rate to TPIAO was 60%, a significant improvement over the 36.5% response to the steroid by itself. 3SBio said the TPIAO group reached effective platelet counts in seven days, faster than the 10 days for the control group. The treatment group recorded an overall adverse events rate of 34%, higher than the control group, which experienced an adverse events rate of 26%.

3SBio has also filed for SFDA approval of NuLeusin and High-Dose EPIAO. NuLeusin is a second generation IL-2 intended as a treatment for late-stage metastatic renal cell carcinoma. 3SBio filed for SFDA approval of NuLeusin in November of 2008. High-Dose EPIAO is a 36,000 IU dose of 3sBio’s EPO drug for chemotherapy-induced anemia that allows for less-frequent administration. It was submitted to the SFDA in September 2008. 3SBio says that all three of its drugs currently in front of the SFDA have no direct competitors.

In Q3 of 2008, 3SBio derived $6.3 million of revenue from its presently approved versions of EPIAO and $2.9 million from TPO products. However, the TPO line is growing faster. TPO products were up 39% in the quarter, while EPIAO increased 17.5%.

Disclosure: none.

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Feb 04 05:02 AM