[One picture, one drug] Hengrui's new class 1 drug, Hytrobopar ethanolamine tablets, was approved for marketing

On June 16, 2021, the National Medical Products Administration approved the first class innovative drug Hytrapopapaethanolamine Tablets declared by Jiangsu Hengrui Pharmaceutical Co.
, Ltd.
through the priority review and approval procedure
.

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 immunosuppressive disease (immunethrombocytopenia, ITP), and adult patients with severe aplastic anemia (SAA) who have poor efficacy on immunosuppressive therapy
.

The SAA indications are conditional approval
.

Hetropopaethanolamine tablet is an orally absorbed small molecule non-peptide thrombopoietin (Tpo) receptor agonist, which activates TpoR-dependent STAT and Tpo by selectively binding to the transmembrane region of the thrombopoietin receptor The MAPK signal transduction pathway stimulates the proliferation and differentiation of megakaryocytes to produce platelets to increase platelets.
13 years ago, the FDA approved Eltrombopag is the world’s first drug of its kind, and PMDA approved atrobopar 7 years later.
, Hetropopaethanolamine is the first small molecule non-peptide thrombopoietin (Tpo) receptor agonist in China [1]
.

 ITP, also known as immune thrombocytopenic purpura, is an autoimmune disease.
The prevalence of adult ITP is about 10/105, and the incidence rate is 1.
6 to 3.
9/105/year [2]
.

The first-line clinical medication is glucocorticoid, which has many adverse reactions and contraindications.
The course of treatment should be as short as possible
.
Patients who cannot maintain the effect after reduction and stop should consider second-line treatment . SAA is a rare blood disease.
The survival rate within half a year after the onset of SAA is not more than 10%.
Immunosuppressive therapy is often used in addition to bone marrow transplantation, but it cannot improve severe stem cell defects [3] 
.

        In the results of a multi-center, randomized, double-blind, and open phase III clinical study (NCT03222843) in patients with primary immune thrombocytopenia (n=414), Hetropopaethanolamine tablets reached 58.
9% in the HETROM-2.
5 group Primary endpoint (odds ratio [OR] 25.
97, 95% confidence interval [CI] 9.
83 ~ 68.
63; p<0.
0001), 64.
3% of patients in the HETROM-5 group reached the primary endpoint (odds ratio [OR] 32.
81, 95% confidence interval 12.
39 ~ 86.
87; p<0.
0001), which were significantly higher than 5.
9% of the placebo group
.

 Compared with Eltrombopag, the structure of ethanolamine is more selective for receptors and safer.
The listing of this variety provides new treatment options for patients with ITP and SAA.
It is expected to become the MeBetter variety of Eltrombopag.

.

For details of hytraboparethanolamine tablets and the competitive landscape of small molecule non-peptide thrombopoietin (Tpo) receptor agonists, see the figure below: (click to enlarge) or click the link below to get the corresponding PDF HD version: https:/ /data.
pharmacodia.
com/v3/insight/#/ListPdf?tag=2 Reference materials 1.
Drug crossing data https://data.
pharmacodia.
com.
2.
Audia S, Mahévas M, Samson M, Godeau B, Bonnotte B.
Pathogenesis of immune thrombocytopenia.
Autoimmun Rev.
2017 Jun;16(6):620-632.
doi:10.
1016/j.
autrev.
2017.
04.
012.
Epub 2017Apr 17.
3.
Scheinberg P.
Activity of eltrombopag insevere aplastic anemia.
Hematology Am SocHematolEduc Program.
2018 Nov 30;2018(1):450-456.
doi:10.
1182/asheducation-2018.
1.
450.
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