Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.3SBio, a biotechnology company, has announced that it filed on December 30, 2008 with the Chinese State Food and Drug Administration for approval of a TPIAO label extension for the treatment of idiopathic thrombocytopenic purpura in China.
Subscribe to our email newsletter
If the extension is approved, 3SBio expects that TPIAO for idiopathic thrombocytopenic purpura (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.
Jing Lou, CEO of 3SBio, said: 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 R&D 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.