Hengrui Medicine's Class 1 new drug, Hytrapapax, was approved, and competition in the domestic TPOR agonist market intensified

On June 17th, according to the official website of NMPA, Hengrui Medicine's Class 1 innovative drug Hytropopaethanolamine Tablets was approved in China for the treatment of glucocorticoids, immunoglobulins, etc.
, which have an increased risk of bleeding due to thrombocytopenia and clinical conditions.
Adult patients with chronic primary immune thrombocytopenia (ITP) who do not respond well to treatment, and adult patients with severe aplastic anemia (SAA) who do not respond well to immunosuppressive therapy, are traded under the name Hengqu
.

Hetropopag ethanolamine is a small molecule non-peptide thrombopoietin receptor (TPOR) agonist with independent intellectual property rights and oral absorption developed by Hengrui after a series of structural modifications to Eltropopag
.

According to clinical trials registered in China, in addition to the above two approved indications, Hetropopaethanolamine has also been developed to treat children and adolescents with chronic primary immune thrombocytopenia, thrombocytopenia caused by chemotherapy of malignant tumors, etc.

So far, there are 4 types of TPOR agonists approved in China, namely, 3SBio's recombinant human thrombopoietin (trade name: TPIAO), Novartis' Atrobopar (trade name: Refulan), and Eisai Avatropolamine (trade name: Su Kexin) and Hengrui Medicine’s Hetropopag ethanolamine (trade name: Hengqu)
.

• TPIAO, first approved in China in January 2005, is currently the world’s only commercial recombinant human thrombopoietin product, and its indications include chemotherapy-induced thrombocytopenia and idiopathic thrombocytopenic purpura (ITP) After entering the national medical insurance catalogue in September 2017, it has rapidly increased its sales, and its sales in 2020 will reach 2.
763 billion yuan
.

• Reflex is a once-a-day oral non-peptide TPO-R agonist developed by GSK (later transferred to Novartis due to asset replacement).
It was approved in the United States in 2008 and the trade name is Promacta, Europe and other countries The product name is Revolade in Japan and the region.
The currently approved indications include chronic immune thrombocytopenia (ITP) in adults and children who do not respond well to other treatments, and thrombocytopenia in patients with chronic hepatitis C virus (HCV) infection.
, The first-line treatment of severe aplastic anemia (SAA) patients with insufficient response to immunosuppressive therapy (IST) and SAA patients in adults and children over two years of age
.

In China, Reflex was approved by the NMPA in December 2017 for the treatment of thrombocytopenia in patients with chronic primary immune thrombocytopenia (ITP) after splenectomy or chronic primary immune thrombocytopenia (ITP) after glucocorticoid drugs, immunoglobulin therapy has failed.

       •Su Kexin is a second-generation, once-daily oral TPOR agonist.
It was approved in the United States in May 2018.
The approved indications so far include adult patients with chronic liver disease (CLD) undergoing elective diagnostic procedures or surgery Adult patients with thrombocytopenia and chronic immune thrombocytopenia (ITP) who do not respond to previous therapies
.

In China, the drug was approved by the NMPA in April 2020 for use in adult CLD-related thrombocytopenia undergoing elective diagnostic procedures or surgery.

       At present, the specific domestic sales of Riverland and Su Kexin are unknown, but they are expected to have a place in the domestic market due to their oral advantages, curative effects, and access to medical insurance
.

The approval of Hytroboparethanolamine will further intensify the competition in the domestic TPOR agonist market

       In addition, there is a domestic TPOR agonist that has been reported for production, that is, Romigrastim of Kylin Fermented by Concord, and the declared indication is ITP
.

The drug is a genetically recombinant protein developed by Amgen.

       Moreover, at present, domestic companies have begun to deploy the TPOR agonist generic drug market.