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    Home > Chemial News > Pharma News > The third domestic company, Qilu Eltrodopal ethanolamine generic drug production

    The third domestic company, Qilu Eltrodopal ethanolamine generic drug production

    Echemi 2021-01-22

    On January 20th, according to the CDE official website, Qilu Pharmaceutical’s application for the 4 generic drug Eltropopa ethanolamine tablets was accepted by CDE, which means that Qilu Pharmaceutical has become the third domestic company to submit after Osaikang Pharmaceutical and Chia Tai Tianqing. Companies applying for the listing of a generic drug of Eltrombopag ethanolamine.

     

    Eltrombopag is a non-peptide oral thrombopoietin receptor (TPO-R) agonist that binds to the TPO receptor (transmembrane region) on the cell membrane to activate signal transduction pathways and stimulate humans The differentiation and proliferation of bone marrow progenitor cells into megakaryocytes promote the maturation of megakaryocytes, thereby increasing the production of platelets. Moreover, the action sites of Eltrodipramide and endogenous TPO are different. They will not compete with endogenous TPO for receptors, have no cross-resistance with peptide TPO, will not induce the production of TPO antibodies, and can achieve stable Increase platelet levels.

            

    At present, the original research Eltrombopag ethanol has been approved for a variety of indications, including: (1) For adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who do not respond to or are intolerant to other drugs The treatment of thrombocytopenia; (2) for the treatment of patients with severe aplastic anemia (SAA) refractory to other drugs; (3) for the treatment of thrombocytopenia in patients with chronic hepatitis C (CHC) in order to start And maintain the standard therapy of liver disease based on interferon; (4) For the treatment of thrombocytopenia in ITP pediatric patients 1 year and older who have insufficient response to corticosteroids, immunoglobulin, and splenectomy; (5) Combined standard immunization Inhibition therapy (IST), the first-line treatment of SAA in children and adults aged 2 years and older. However, the trade name of Aitropoppa in the United States is Promacta, and its trade name in Europe and other countries and regions is Revolade.

     

    The original research Atrobopa was developed by GlaxoSmithKline, and Novartis acquired the product through an asset swap transaction with GlaxoSmithKline in 2014. According to the company's financial report, in recent years, Promacta/Revolade's global sales have maintained a growing trend. In 2018, it exceeded $1 billion and became a blockbuster product of Novartis.

     

    In China, the original research Eltrodopaethanolamine tablets were approved by NMPA in December 2017 for the treatment of patients with chronic primary immune thrombocytopenia (ITP) after splenectomy or chronic primary immune thrombocytopenia (ITP) after glucocorticoid drugs, immunoglobulin therapy failed Thrombocytopenia, the trade name is Revellan. In 2019, Riverland successfully entered the category B scope of the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog", and successfully renewed the 2020 medical insurance catalog. Reflex has approved two specifications in China, namely 25mg/capsule and 50mg/capsule. According to the insight database, the winning price of a box (25mg*28 tablets) of Reflex is 5968 yuan, which is still far more than the national payment. ability.

     

    It is reported that the domestic compound patent CN100423721C of Eltrombopag will expire in 2021. At present, there is no domestic generic drug approved, but many companies have begun to deploy their generic drug market. Among them, Osaikang Pharmaceutical, Chia Tai Tianqing and Qilu Pharmaceutical have successively submitted applications for the listing of 4 generic drugs. Yuanda Pharmaceutical and Sichuan Kelun Pharmaceutical are conducting BE trials, and the other 7 companies have approved clinical trials.

     

    Hengrui Medicine is about to enter the market, the domestic TPO-R agonist original research, imitation big PK

     

    The advent of TPO-R agonists has provided new therapies for the treatment of thrombocytopenia and has become one of the popular targets for enterprise research and development. At present, 5 TPO-R drugs have been approved worldwide, namely lutropopag, eltropopag, romipristin, avatropopag and thrombopoietin. See the table below for details.

     

    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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