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    Home > Medical News > Medical Research Articles > Chengdu Shengdi Pharmaceutical's Mycophenolate Sodium Enteric-coated Tablets to be imitated in Category 4 will be approved soon

    Chengdu Shengdi Pharmaceutical's Mycophenolate Sodium Enteric-coated Tablets to be imitated in Category 4 will be approved soon

    • Last Update: 2021-03-27
    • Source: Internet
    • Author: User
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    Medical Network News on March 23 A few days ago, Chengdu Shengdi Pharmaceutical entered the administrative examination and approval stage with mycophenolate sodium enteric-coated tablets for imitation of category 4 applications.
    The product has not been approved for the first imitation in China.
    According to data from Meinnet.
    com, Novartis’s Mycophenolate sodium enteric-coated tablets sold more than 700 million yuan in China's public medical institutions in 2019, and the growth rate reached 16.
    33% in the first half of 2020.
     
    Source: official website of the State Food and Drug Administration
     
    Mycophenolate sodium is a selective, non-competitive, and reversible hypoxanthine monophosphate dehydrogenase (IMPDH) inhibitor, which can inhibit the classical synthesis pathway of guanine nucleotides without damaging DNA synthesis.
    It can be used in combination with cyclosporine and corticosteroids to prevent acute rejection in adult patients receiving allogeneic kidney transplantation.
     
    Novartis's mycophenolate sodium enteric-coated tablets were approved to enter the domestic market in January 2009, and currently no generic drugs have been approved for listing.
    According to data from Mi Nei.
    com, the terminal sales of this product in China's urban public hospitals, county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) exceeded 700 million yuan in 2019, and exceeded 300 million yuan in the first half of 2020.
    A year-on-year increase of 16.
    33%.
     
      New classification of mycophenolate sodium enteric-coated tablets
      Source: Mi Nei Net Consistency Evaluation Database
     
      At present, only Chengdu Shengdi Pharmaceutical and Kangzhe Biology have submitted applications for the listing of mycophenolate sodium enteric-coated tablets under the new registration classification.
    Among them, Chengdu Shengdi Pharmaceutical's products have entered the administrative approval stage first and are expected to win the first imitation.
     
      The new classification is reported for production and there is no immunosuppressant approved for the first imitation
      Source: Meinenet MED2.
    0 Chinese Drug Evaluation Database
     
      According to data from Meinenet, among the immunosuppressants currently under review for production under the new classification, 5 have not been approved for the first imitation (including the first imitation of the dosage form).
    Among them, Sanofi’s teriflunomide will be sold globally in 2020.
    The amount exceeds 2 billion euros.
     
      Source: Minet database
     
      Note: The statistics are as of March 22.
    If there are any omissions, please correct me!
      Medical Network News on March 23 A few days ago, Chengdu Shengdi Pharmaceutical entered the administrative examination and approval stage with mycophenolate sodium enteric-coated tablets for imitation of category 4 applications.
    The product has not been approved for the first imitation in China.
    According to data from Meinnet.
    com, Novartis’s Mycophenolate sodium enteric-coated tablets sold more than 700 million yuan in China's public medical institutions in 2019, and the growth rate reached 16.
    33% in the first half of 2020.
     
      
    Source: official website of the State Food and Drug Administration
     
      Mycophenolate sodium is a selective, non-competitive, and reversible hypoxanthine monophosphate dehydrogenase (IMPDH) inhibitor, which can inhibit the classical synthesis pathway of guanine nucleotides without damaging DNA synthesis.
    It can be used in combination with cyclosporine and corticosteroids to prevent acute rejection in adult patients receiving allogeneic kidney transplantation.
     
      Novartis's mycophenolate sodium enteric-coated tablets were approved to enter the domestic market in January 2009, and currently no generic drugs have been approved for listing.
    According to data from Mi Nei.
    com, the terminal sales of this product in China's urban public hospitals, county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) exceeded 700 million yuan in 2019, and exceeded 300 million yuan in the first half of 2020.
    A year-on-year increase of 16.
    33%.
     
      New classification of mycophenolate sodium enteric-coated tablets
      Source: Mi Nei Net Consistency Evaluation Database
     
      At present, only Chengdu Shengdi Pharmaceutical and Kangzhe Biology have submitted applications for the listing of mycophenolate sodium enteric-coated tablets under the new registration classification.
    Among them, Chengdu Shengdi Pharmaceutical's products have entered the administrative approval stage first and are expected to win the first imitation.
     
      The new classification is reported for production and there is no immunosuppressant approved for the first imitation
      Source: Meinenet MED2.
    0 Chinese Drug Evaluation Database
     
      According to data from Meinenet, among the immunosuppressants currently under review for production under the new classification, 5 have not been approved for the first imitation (including the first imitation of the dosage form).
    Among them, Sanofi’s teriflunomide will be sold globally in 2020.
    The amount exceeds 2 billion euros.
     
      Source: Minet database
     
      Note: The statistics are as of March 22.
    If there are any omissions, please correct me!
      Medical Network News on March 23 A few days ago, Chengdu Shengdi Pharmaceutical entered the administrative examination and approval stage with mycophenolate sodium enteric-coated tablets for imitation of category 4 applications.
    The product has not been approved for the first imitation in China.
    According to data from Meinnet.
    com, Novartis’s Mycophenolate sodium enteric-coated tablets sold more than 700 million yuan in China's public medical institutions in 2019, and the growth rate reached 16.
    33% in the first half of 2020.
     
      
    Source: official website of the State Food and Drug Administration
     
      Mycophenolate sodium is a selective, non-competitive, and reversible hypoxanthine monophosphate dehydrogenase (IMPDH) inhibitor, which can inhibit the classical synthesis pathway of guanine nucleotides without damaging DNA synthesis.
    It can be used in combination with cyclosporine and corticosteroids to prevent acute rejection in adult patients receiving allogeneic kidney transplantation.
     
      Novartis's mycophenolate sodium enteric-coated tablets were approved to enter the domestic market in January 2009, and currently no generic drugs have been approved for listing.
    According to data from Mi Nei.
    com, the terminal sales of this product in China's urban public hospitals, county-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions) exceeded 700 million yuan in 2019, and exceeded 300 million yuan in the first half of 2020.
    A year-on-year increase of 16.
    33%.
     
      New classification of mycophenolate sodium enteric-coated tablets
      Source: Mi Nei Net Consistency Evaluation Database
     
      At present, only Chengdu Shengdi Pharmaceutical and Kangzhe Biology have submitted applications for the listing of mycophenolate sodium enteric-coated tablets under the new registration classification.
    Among them, Chengdu Shengdi Pharmaceutical's products have entered the administrative approval stage first and are expected to win the first imitation.
     
      The new classification is reported for production and there is no immunosuppressant approved for the first imitation
      Source: Meinenet MED2.
    0 Chinese Drug Evaluation Database
     
      According to data from Meinenet, among the immunosuppressants currently under review for production under the new classification, 5 have not been approved for the first imitation (including the first imitation of the dosage form).
    Among them, Sanofi’s teriflunomide will be sold globally in 2020.
    The amount exceeds 2 billion euros.
     
      Source: Minet database
     
      Note: The statistics are as of March 22.
    If there are any omissions, please correct me!
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