3SBio Inc, a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, announced that it filed on December 30, 2008 with the Chinese State Food and Drug Administration (SFDA) for approval of a TPIAO label extension for the treatment of idiopathic thrombocytopenic purpura (ITP) in China. If the extension is approved, 3SBio expects that TPIAO for ITP will be the only treatment of this kind available in China.
Launched in 2006, TPIAO is a recombinant human thrombopoietin product approved in China for the treatment of chemotherapy induced thrombocytopenia, or platelet deficiency. The aim of this filing is to extend the label of TPIAO for use in 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. At present, there are approximately 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 stimulating the TPO receptor, which is intended to have the effect of directly increasing platelet production to outpace platelet destruction by the immune system. The registration trial examined the safety and efficacy of a 14-day subcutaneous injection of TPIAO on ITP patients who are resistant to steroid treatment, followed by a 14-day observation period. The results showed an overall patient response rate to TPIAO treatment of 60.27 per cent, significantly higher than the Danazol control group response rate of 36.51 per cent. Patients administered TPIAO also reached effective platelet counts in seven days, compared to 10 days for patients within the control group.
Dr Jing Lou, chief executive officer of 3SBio, commented, "The filing of TPIAO for ITP successfully caps our development initiatives for 2008 and we now have three new product candidates in the approval pipeline. As with NuLeusin and high dosage EPIAO, TPIAO for ITP represents a logical extension of an existing product franchise, in-line with our therapeutic focus and growth strategy. The successful completion of our three phase-III trials demonstrates the strength of our research and development platform and highlights our operational excellence. Upon approval, TPIAO for ITP would provide a new treatment option for patients and will further enhance our footprint within China's growing pharmaceutical market."
3SBio is a leading, fully integrated biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, primarily in China.