China-based 3SBio Inc. (HKG: 1530) has announced the enrollment of the first patient in a Phase III clinical study for its thrombopoietin, which is being assessed for the treatment of thrombocytopenia in patients with chronic liver disease who are planned for invasive surgery.
Background of 3SBio’s Thrombopoietin (TPIAO)
Developed in-house, 3SBio’s recombinant thrombopoietin is marketed under the brand name TPIAO. It was first approved for marketing in China in May 2005 for chemotherapy-induced thrombocytopenia and later for primary immune thrombocytopenia (ITP) in adults in 2010. In November 2022, the drug was filed for pediatric ITP and was accepted for review by the National Medical Products Administration (NMPA). The current Phase III trial is evaluating the safety, tolerability, pharmacokinetics (PK), and initial efficacy of TPIAO in patients with chronic liver disease and thrombocytopenia.
Significance of Thrombocytopenia in Chronic Liver Disease
Thrombocytopenia is a common complication associated with chronic liver disease, with its severity often correlating with the degree of liver impairment. Approximately 78% of patients with liver cirrhosis experience varying degrees of thrombocytopenia. The primary cause of thrombocytopenia in these patients is a decrease in the production of thrombopoietin (TPO), with other contributing factors including hypersplenism, increased platelet destruction, and virus suppression of bone marrow function.-Fineline Info & Tech
