On January 11, Hengrui Medicine announced that the company has received a letter from the US FDA regarding the approval of the clinical trial of Hetrombopag ethanolamine tablets, and will conduct a phase III clinical trial of thrombocytopenia caused by chemotherapy for malignant tumors in the near future
.
Hetrombopag ethanolamine tablets were approved by the State Drug Administration to conduct clinical trials for the treatment of aplastic anemia in December 2017 (announcement number: Lin 2017-080), and in August 2019, they were approved to carry out tumor chemotherapy-induced thrombocytopenia The clinical trial of CIT (Announcement No.
: Lin 2019-055) was approved in November 2020 to conduct a phase III clinical trial in children and adolescents with chronic primary immune thrombocytopenia
.
After obtaining the U.
S.
FDA clinical trial qualification this time, the clinical study of hetrombopag in the treatment of malignant tumor chemotherapy-induced thrombocytopenia is planned to be carried out in the United States, Europe and Australia
.
Hetrombopag ethanolamine tablets (trade name: Hengqu) was approved by the State Drug Administration in June 2021 for chronic primary immune thrombocytopenia that has not responded well to glucocorticoids, immunoglobulins, etc.
(ITP) in adults and for the treatment of adults with severe aplastic anemia who do not respond to immunosuppressive therapy
.
Hetrombopag ethanolamine is an oral non-peptide thrombopoietin receptor (TPO-R) agonist that promotes thrombopoiesis by activating TPO-R-mediated STAT and MAPK signaling pathways
.
After inquiries, there are currently foreign products like Eltrombopag (GlaxoSmithKline, trade name Promacta), Avatrombopag (Dova Pharmaceuticals, trade name Doptelet), Lusutrombopag (Shionogi, trade name Mulpleta) approved for listing
.
In China, Eltrombopag was approved for marketing in 2017.
The product name is Eltrombopag ethanolamine tablets.
It is used for adult patients with chronic immune (idiopathic) thrombocytopenia (ITP).
Avatrombopag was approved for marketing in 2020.
The product name is Avatrombopag maleate tablets for adult patients with chronic liver disease-related thrombocytopenia who are scheduled to undergo diagnostic procedures or surgery
.
After querying the EvaluatePharma database, the global sales of Promacta, Doptelet and Mulpleta in 2020 were approximately US$1.
799 billion
.
Up to now, about 213.
1 million yuan has been invested in research and development projects related to Haitrombopag ethanolamine tablets
.
