The Chinese regulatory authority has cleared 3Sbio’s TPIAO® for the treatment of idiopathic thrombocytopenic purpura (ITP). The recombinant human thrombopoietin product has been available in China since 2006 for treating chemotherapy-induced thrombocytopenia. Application for approval
for the ITP indication was submitted to China’s State Food and Drug Administration in December 2008.
Marketing approval for the new indication was based on data from a Phase III study in ITP patients who failed to respond to glucocorticoid therapy. Participants were randomized to receive either the synthetic steroid hormone drug Danazol alone, or Danazol in combination with subcutaneously administered TPIAO. Results showed the overall response rate in the treatment group was 60.27%, compared with 36.51% for the control group. Patients receiving TPIAO also achieved a faster platelet response time than those treated using just Danazol.
“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,” notes Jing Lou, M.D., 3SBio director and CEO. “This additional indication complements our existing indication for chemotherapy-induced platelet deficiency, which has been rapidly adopted by the medical community.”
Shenyang-based 3SBio is focused on the development of biopharmaceuticals for the Chinese market, particularly in the fields of oncology and nephrology. Aside from TPIAO, the firm’s marketed products in its home country include: EPIAO®, a recombinant human erythropoietin injection for the treatment of anemia associated with renal failure (including dialysis patients); Intefen®, a recombinant interferon alpha-2a for the treatment of a range of lymphatic/hemopoietic tumors and chronic hepatitis B and C infection; and Inleusin®, a recombinant human interleukin-2 for the treatment of metastatic renal cell carcinoma, malignant melanoma, and the control of carcinomatous hydrothorax and hydroperitoneum. 3SBio’s intravenous IV Iron Sucrose product, in-licensed from Shenyang Borui Pharmaceutical, is indicated for treating anemia associated with iron deficiency in patients with end-stage renal disease requiring iron replacement therapy.
A number of products have in addition been submitted for regulatory approval by the Chinese authorities. These include a high-dose EPIAO for treating anemia associated with chemotherapy, and a next-generation Inleusin product, Nuleusin, for the treatment of renal cell carcinoma and metastatic carcinoma. Preclinical pipeline products include an anti-TNF humanized monoclonal antibody candidate for the treatment of rheumatoid arthritis and other autoimmune diseases, and an HPV vaccine against cervical cancer.