China-based 3SBio Inc. (HKG: 1530) has announced that the National Medical Products Administration (NMPA) has accepted another market filing for its recombinant thrombopoietin for the treatment of persistent or chronic primary immune thrombocytopenia (ITP) in children or adolescents. This marks a significant step forward in expanding the therapeutic indications for 3SBio’s product.
Thrombopoietin Profile
3SBio’s recombinant thrombopoietin, marketed under the brand name TPIAO, was first approved for marketing in China in May 2005 for the treatment of chemotherapy-induced thrombocytopenia. A second indication for ITP in adults was approved in 2010. A multi-center, randomized, double-blind, placebo-controlled Phase III clinical study assessing the safety, efficacy, and pharmacokinetics of thrombopoietin in chronic primary ITP reached its pre-set primary endpoint in May of this year.
ITP Treatment Landscape
ITP, an acquired autoimmune hemorrhagic disease, requires patients to participate in treatment decision-making to achieve optimal platelet counts while minimizing adverse treatment reactions and reducing bleeding events. China’s ITP treatment guidelines recommend thrombopoietin as a second-line therapy. The acceptance of 3SBio’s market filing by the NMPA underscores the potential of thrombopoietin as a valuable treatment option for pediatric and adolescent patients with chronic ITP.-Fineline Info & Tech
