The third domestic company, Qilu Eltrodopal ethanolamine generic drug production
In China, only the recombinant thrombopoietins of Alvatropol, Eltropol, and 3SBio have been approved. Among them, Avatrobopa was approved by the NMPA in April 2020 for the treatment of adult patients with chronic liver disease (CLD)-related thrombocytopenia undergoing selective diagnostic procedures or surgery. The trade name is Su Kexin, which is developed in China And the sales right was exclusively authorized to Fosun Pharma in March 2018. 3SBio's recombinant thrombopoietin, TPIAO, was first approved in China in January 2005. It is currently the only commercial recombinant human thrombopoietin product in the world. Its indications include chemotherapy-induced thrombocytopenia and immunity Thrombocytopenia, it is reported that its sales in 2019 exceeded 2 billion yuan, and it was included in the 2019 National Medical Insurance Catalogue. According to the insight database, other domestic companies are also deploying the thrombopoietin market, such as Pijin Biological and Kanghe Biological.
In addition, Concord Fermented Kirin's Romipristine and Hengrui Medicine's Hetropopagolamine have already submitted domestic listing applications. Among them, Hetropopag ethanolamine is Hengrui Medicine's after a series of structural modifications to Eltropopag. A small molecule non-peptide TPO-R agonist with independent intellectual property rights and oral absorption has been developed. Compared with Eltrodopag, Hytrobopar ethanolamine is more efficient and less toxic. In June 2020, the first domestic production of Hytrapopapax was submitted, and then the second domestic listing application was submitted in July 2020. Romipristine is a second-generation oral TPO-R agonist and the first platelet-increasing drug approved by the FDA. It will be launched in China in April 2020. However, according to the insight database, domestic companies have begun to deploy the romigrastim biosimilar market, among which Qilu Pharmaceutical has made the fastest progress and is in the phase III clinical stage. The above-mentioned Lutrobopalpa has been exclusively authorized by Eton Medicine to be introduced into China and is currently undergoing Phase III clinical trials.
With the approval of the above-mentioned TPO-R agonists, competition in the domestic TPO-R track will surely become fiercer, and fierce battles between domestic original research, imported and generic drugs will be launched.
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