3SBio Inc. (HKG: 1530), a leading biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its thrombopoietin product, used in the treatment of persistent or chronic primary immune thrombocytopenia (ITP) in children or adolescents. This marks a significant expansion of the product’s indication in the pediatric demographic.
3SBio’s recombinant thrombopoietin, branded as TPIAO, was initially approved for marketing in China in May 2005 for the treatment of chemotherapy-induced thrombocytopenia. It received a second indication approval for ITP in adults in 2010. The company’s thrombopoietin is also under exploration in a study assessing its safety, tolerability, pharmacokinetics (PK), and preliminary efficacy in patients with chronic liver disease complicated by thrombocytopenia.
ITP is an acquired autoimmune hemorrhagic disorder characterized by low platelet counts. 3SBio has previously conducted a Phase III study of thrombopoietin in children with ITP in China, successfully achieving primary endpoints for efficacy and safety.- Flcube.com
