Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review another indication approval filing for its drug candidate, hetrombopag olamine. This new indication is for the use of hetrombopag olamine in combination with immunosuppressive therapy to treat patients aged 15 and above with newly diagnosed severe aplastic anemia (SAA).
Herombopag olamine, a highly selective non-peptide drug similar to Novartis’ Revolade (eltrombopag olamine), received approval in China in June 2021 for the treatment of chronic primary immune thrombocytopenia (ITP) that has not responded well to treatments such as glucocorticoids and immunoglobulins due to thrombocytopenia and clinical conditions that increase the risk of bleeding. The drug also obtained conditional market approval for the treatment of adult patients with severe aplastic anemia (SAA) who do not respond to immunosuppressive therapy.
The current filing is supported by the positive results of the Phase III HR-TPO-SAA-Ⅲ study, which enrolled a total of 240 patients aged 15 and above with newly diagnosed SAA and reached its pre-set primary endpoint in May 2024. The study demonstrated that herombopag olamine was significantly superior to the control group in the primary endpoint, exhibiting good safety and efficacy in long-term treatment. No new safety signals were identified compared to other TPO receptor agonists.- Flcube.com
