By Fineline Cube 
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that the indication expansion for its drug hetrombopag olamine has been accepted by China’s National Medical Products Administration (NMPA). The expanded approval covers adult patients and children aged ≥6 years with persistent and chronic primary immune thrombocytopenia (ITP) who have had an inadequate response to prior treatments such as glucocorticoids and immunoglobulins.
Previous Approvals
Hetrombopag olamine has already been approved by the NMPA for two indications:
- Treatment of adult patients with chronic ITP who have shown an inadequate response to prior treatments such as glucocorticoids and immunoglobulins.
- Treatment of adult patients with severe aplastic anemia who have demonstrated an inadequate response to immunosuppressive therapy.
Clinical Trial Basis
The expanded indication is supported by positive results from a Phase 3 clinical trial (HR-TPO-ITP-Ⅲ-PED). The trial evaluated the efficacy and safety of hetrombopag olamine in pediatric and adolescent patients with ITP and achieved its primary endpoint.-Fineline Info & Tech