SHENYANG, China, Jan. 24, 2011 /PRNewswire-Asia-FirstCall/ -- 3SBio Inc. (Nasdaq: SSRX) ("3SBio" or " Company"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that it has received official notification from China's State Food and Drug Administration ("SFDA") granting 3SBio manufacturing approval for a TPIAO label extension for the treatment of idiopathic thrombocytopenic purpura ("ITP"). The approval application was submitted in December 2008.
Jing Lou, MD, PhD, Director and Chief Executive Officer of 3SBio, commented: "We are pleased that TPIAO's label extension for the treatment of ITP has been approved by the SFDA. This additional indication complements our existing indication for chemotherapy induced platelet deficiency which has been rapidly adopted by the medical community since its approval in 2006. 3SBio was the first company globally to research, develop and commercialize a recombinant human thrombopoietin product and TPIAO remains the only product of its kind available in China. We will continue to focus on introducing innovative treatments for other unmet medical needs in China."
Launched in 2006, TPIAO is a recombinant human thrombopoietin product initially approved in China for the treatment of chemotherapy induced thrombocytopenia, or platelet deficiency. The SFDA has now approved the extension of TPIAO's label to include the treatment of ITP. ITP is characterized by an immune system malfunction that perceives the body's platelets as foreign and destroys them, potentially resulting in dangerously low platelet counts. There are an estimated eighty thousand patients diagnosed with ITP in China, with more than half of these patients resistant to conventional steroid treatment.
TPIAO represents a new approach for the treatment of ITP, by sti
|SOURCE 3SBio Inc.|
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