Other Name: rhTPO

TPIAO is a recombinant human thrombopoietin (rhTPO) product used for the treatment of certain types of thrombocytopenia, a deficiency of platelets. Thrombopoietin (TPO) is a hemopoietic, or blood or blood cell-related, growth factor protein. TPO stimulates production of megakaryocytes, cells with a multilobed nucleus in the bone marrow and liver, which release mature platelets and raise the circulating platelet count in the blood. TPIAO may be used to stimulate platelet production in patients suffering from platelet deficiency associated with blood stem cell transplantation, cancer chemotherapy, late-state liver diseases, or for other pathological reasons.

We are the first company in the world to have developed and commercialized an rhTPO product. Since its launch in 2006, TPIAO has remained the only approved rhTPO product in China. TPIAO has been approved by the CFDA for two indications.

• In 2005, TPIAO’s first indication, the treatment of CIT, was approved by the CFDA. TPIAO is included in the National Medical Insurance Catalogue as a Category B drug for the treatment of CIT in connection with work-related injuries and was the only product included under the platelet boosting drug category. TPIAO is also included in seven provincial medical insurance catalogues (Hainan, Heilongjiang, Jilin, Liaoning, Shaanxi, Shanghai and Tibet) for the treatment of CIT without the work-related injury limitation.

• In 2010, TPIAO’s second indication, the treatment of ITP, was approved by the CFDA. The Chinese Experts’ Consensus on the Diagnosis and Treatment of Adult Primary Immune Thrombocytopenia (Revised) 《(成人原發免疫性血小板减少症診治的中國專家共識(修訂版)》), published in March 2011, recommended rhTPO as a secondary treatment of ITP. TPIAO is included in one provincial medical insurance catalogue (Tibet) for the treatment of ITP.

TPIAO is manufactured at our mammalian cell-based production plant in Shenyang. Our TPIAO products are available in two dosages, 7,500 units and 15,000 units.

TPIAO was recognized as a National Key New Product by four PRC state ministries in 2006 and has been recognized as a National Class I New Drug by the CFDA. The following table sets forth the material awards TPIAO has received:

AwardGrantor
First Class Award for the Advancement of Science Shenyang municipal government
First Class Award for Excellent New Products Liaoning provincial government

 

We are currently in the process of applying for regulatory approval to market TPIAO in the United States. We expect to file an IND application with the USFDA in 2015 and plan to start Phase I clinical trials in the United States shortly after the IND application is approved.