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Hengrui's Application for New Class 1.1 Drug Hetrombopag Ethanolamine Tablets was Accepted by CDE

PharmaSources/DopineJune 19, 2020

Tag: Hengrui , Class 1.1 , New Drug , Hetrombopag ethanolamine tablets

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On June 18, the application for marketing of Hengrui's new class 1.1 drug Hetrombopag ethanolamine tablets was accepted by CDE.

Hetrombopag ethanolamine tablets is a small-molecule non-peptide thrombopoietin receptor (TPOR) agonist developed with independent intellectual property rights by Hengrui after a series of structural modifications to Eltrombopag which was jointly developed by GSK/Norvatis, mainly used for the treatment of chronic primary immune thrombocytopenia (ITP) with poor efficacy for glucocorticoid drugs, immunoglobulins or splenectomy. Compared with Eltrombopag, Hetrombopag ethanolamine is more efficient and less toxic.

According to the Insight Database, currently there are 13 clinical trials registered for Hengrui's Hetrombopag ethanolamine tablets in China. The indications cover (primary) immune thrombocytopenia, thrombocytopenia caused by chemotherapy of malignant tumors, and (heavy) aplastic Anemia, as for the specific indications of the drug applied for production this time to be officially announced.

So far, five TPO-R agonists have been approved globally, namely, Lusutrombopag (Shionogi's), Eltrombopag (Novartis), Romiplostim (Amgen), Avatrombopag(Eisai) and 3SBio's recombinant human thrombopoietin injection(TPIAO). Currently, Eltrombopag, Avatrombopag and TPIAO have been approved in China.

In addition to the above-mentioned approved TPO-R agonists, there are still many companies laying out the TPO-R agonist market in China. Among them, Jiangsu AOSAIKANG Pharm is in fast progress, which has now submitted for its marketing of Class 4 generic drugs. In addition, Chia Tai Tianqing, Qilu Pharma and Grand pharma are conducting the BE trial of Eltrombopag. Qilu Pharma's Romiplostim biosimilar drug-recombinant human thrombopoietin-peptide-Fc fusion protein for injection has reached Phase III clinical stage for primary immune thrombocytopenia indications.

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