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17, the State Food and Drug Administration announcement, recently listed by priority review approval procedures Class 1 drug innovation Haiqu Park Pa ethanolamine piece Jiangsu Hengrui Medicine Co.
, Ltd.
declared
.
This drug is an innovative drug independently researched and developed by China with independent intellectual property rights.
It is used for chronic primary immune thrombocytopenia that has not responded well to treatments such as glucocorticoids and immunoglobulins due to thrombocytopenia and clinical conditions that increase the risk of bleeding.
Adult patients with severe aplastic anemia (ITP), as well as adults with severe aplastic anemia (SAA) who do not respond well to immunosuppressive therapy
.
Among them, the SAA indication is conditional approval
Herombopag Olamine is a small molecule human thrombopoietin receptor (TPO-R) agonist
.
According to relevant statistics, there are currently 5 approved TPO-R drugs in the world, including Lutrobopal, Eltrobopal, Romigrastim, Alvatrobopal, and Thrombopoietin; currently, approved domestically Among them are 3SBio's recombinant human thrombopoietin, Novartis's Eltropopa ethanolamine tablets, and Fosun Pharma's introduction of AkaRx, Inc.