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    Home > Medical News > Medical Research Articles > Kelun Class 1 new drugs are coming this year, 7 new drugs have been approved for clinical use

    Kelun Class 1 new drugs are coming this year, 7 new drugs have been approved for clinical use

    • Last Update: 2021-08-07
    • Source: Internet
    • Author: User
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    A few days ago, the CDE official website showed that Sichuan Kelunbotai Biotech's Class 1 new drug SKB336 injection has obtained the implied clinical trial approval.
    This is a humanized innovative monoclonal antibody targeting FXIa/FXI factors.
    It is intended to be used for the prevention and treatment of thromboembolic diseases
    .
    According to data from Meinenet, since 2021, Kelun Pharmaceutical has been approved for clinical trials of 7 new drugs, of which 5 are Class 1 new drugs
    .
     
    Source: CDE official website
     
    SKB336 injection is a new humanized and innovative monoclonal antibody targeting FXIa/FXI factor with independent intellectual property rights.
    Currently, no drug with the same target has been approved for marketing in the world.
    The research and development progress of the drug in advance includes Bayer's BAY-1213790 and Novartis' abelacimab (abeximab), both products are in phase II clinical trials
    .
     
    According to data from Minaiwang, since 2021, Kelun Pharmaceutical has been approved for clinical trials of 7 new drugs (excluding supplementary applications), of which 5 are Class 1 new drugs, and SKB337 injection is currently undergoing phase I clinical trials
    .
     
      Kelun has been approved for clinical new drugs since 2021
      Source: China Drug Clinical Trial Publicity Library of Meinenet
     
      The SKB337 injection, which is undergoing phase I clinical trials for advanced solid tumor indications, is a new generation of bispecific antibodies for tumor immune checkpoints.
    This biantibody uses a symmetrical IgG1κ-scFv that can act on tumor cells and effector T cells at the same time
    .
    At present, no dual antibody drug with the same target has been approved for marketing in the world
    .
     
      Docetaxel for injection (albumin-binding type) and sildenafil citrate oral membrane are all improved new drugs
    .
    At present, the domestically marketed docetaxel preparation is docetaxel injection, which will be used in Chinese urban public hospitals , county-level public hospitals, urban community centers, township health centers (referred to as Chinese public medical institutions) and physical pharmacies in Chinese cities in 2020.
    The sales scale of the terminal exceeds 3.
    5 billion yuan
    .
     
      At present, the domestically marketed sildenafil preparations mainly include sildenafil citrate tablets and sildenafil citrate orally disintegrating tablets.
    In 2020, the sales scale of sildenafil citrate and sildenafil citrate in Chinese public medical institutions and physical pharmacies in Chinese cities will exceed 2.
    5 billion yuan, of which Chinese urban physical pharmacies are the main "battlefield", with sales accounting for more than 95%
    .
     
      The sales of sildenafil at physical drugstores in cities in China (unit: ten thousand yuan)
      Source: Mi Nei.
    com, China's urban physical pharmacy terminal competition pattern
     
      KL280006 injection is a peripheral κ opioid receptor (KOR) agonist, intended to treat uremia and itching
    .
    No similar compound has been approved for marketing in the world.
    The drug under development with the leading research and development progress is Cara Therapeutics' KORSUVA, and it has submitted a marketing application to the FDA
    .
     
      KL590586 capsule is a small molecule selective targeting RET kinase inhibitor.
    It is intended to treat advanced solid tumors with RET fusion or mutation.
    It is the first pan-tumor precision treatment drug developed by Kelun Pharmaceutical
    .
    In May 2020, the targeted anti-cancer drug Retevmo of Loxo Oncology, a subsidiary of Eli Lilly, was approved by the FDA for marketing, becoming the first approved therapeutic drug for cancer patients carrying RET genetic changes
    .
     
      Source: Mynet database, public company announcements, etc.
      A few days ago, the CDE official website showed that Sichuan Kelunbotai Biotech's Class 1 new drug SKB336 injection has obtained the implied clinical trial approval.
    This is a humanized innovative monoclonal antibody targeting FXIa/FXI factors.
    It is intended to be used for the prevention and treatment of thromboembolic diseases
    .
    According to data from Meinenet, since 2021, Kelun Pharmaceutical has been approved for clinical trials of 7 new drugs, of which 5 are Class 1 new drugs
    .
     
      
    Source: CDE official website
     
      SKB336 injection is a new humanized and innovative monoclonal antibody targeting FXIa/FXI factor with independent intellectual property rights.
    Currently, no drug with the same target has been approved for marketing in the world.
    The research and development progress of the drug in advance includes Bayer's BAY-1213790 and Novartis' abelacimab (abeximab), both products are in phase II clinical trials
    .
     
      According to data from Minaiwang, since 2021, Kelun Pharmaceutical has been approved for clinical trials of 7 new drugs (excluding supplementary applications), of which 5 are Class 1 new drugs, and SKB337 injection is currently undergoing phase I clinical trials
    .
     
      Kelun has been approved for clinical new drugs since 2021
      Source: China Drug Clinical Trial Publicity Library of Meinenet
     
      The SKB337 injection, which is undergoing phase I clinical trials for advanced solid tumor indications, is a new generation of bispecific antibodies for tumor immune checkpoints.
    This biantibody uses a symmetrical IgG1κ-scFv that can act on tumor cells and effector T cells at the same time
    .
    At present, no dual antibody drug with the same target has been approved for marketing in the world
    .
     
      Docetaxel for injection (albumin-binding type) and sildenafil citrate oral membrane are all improved new drugs
    .
    At present, the domestically marketed docetaxel preparation is docetaxel injection, which will be used in Chinese urban public hospitals , county-level public hospitals, urban community centers, township health centers (referred to as Chinese public medical institutions) and physical pharmacies in Chinese cities in 2020.
    The sales scale of the terminal exceeds 3.
    5 billion yuan
    .
     
      At present, the domestically marketed sildenafil preparations mainly include sildenafil citrate tablets and sildenafil citrate orally disintegrating tablets.
    In 2020, the sales scale of sildenafil citrate and sildenafil citrate in Chinese public medical institutions and physical pharmacies in Chinese cities will exceed 2.
    5 billion yuan, of which Chinese urban physical pharmacies are the main "battlefield", with sales accounting for more than 95%
    .
     
      The sales of sildenafil at physical drugstores in cities in China (unit: ten thousand yuan)
      Source: Mi Nei.
    com, China's urban physical pharmacy terminal competition pattern
     
      KL280006 injection is a peripheral κ opioid receptor (KOR) agonist, intended to treat uremia and itching
    .
    No similar compound has been approved for marketing in the world.
    The drug under development with the leading research and development progress is Cara Therapeutics' KORSUVA, and it has submitted a marketing application to the FDA
    .
     
      KL590586 capsule is a small molecule selective targeting RET kinase inhibitor.
    It is intended to treat advanced solid tumors with RET fusion or mutation.
    It is the first pan-tumor precision treatment drug developed by Kelun Pharmaceutical
    .
    In May 2020, the targeted anti-cancer drug Retevmo of Loxo Oncology, a subsidiary of Eli Lilly, was approved by the FDA for marketing, becoming the first approved therapeutic drug for cancer patients carrying RET genetic changes
    .
     
      Source: Mynet database, public company announcements, etc.
      A few days ago, the CDE official website showed that Sichuan Kelunbotai Biotech's Class 1 new drug SKB336 injection has obtained the implied clinical trial approval.
    This is a humanized innovative monoclonal antibody targeting FXIa/FXI factors.
    It is intended to be used for the prevention and treatment of thromboembolic diseases
    .
    According to data from Meinenet, since 2021, Kelun Pharmaceutical has been approved for clinical trials of 7 new drugs, of which 5 are Class 1 new drugs
    .
     
      
    Source: CDE official website
     
      SKB336 injection is a new humanized and innovative monoclonal antibody targeting FXIa/FXI factor with independent intellectual property rights.
    Currently, no drug with the same target has been approved for marketing in the world.
    The research and development progress of the drug in advance includes Bayer's BAY-1213790 and Novartis' abelacimab (abeximab), both products are in phase II clinical trials
    .
     
      According to data from Minaiwang, since 2021, Kelun Pharmaceutical has been approved for clinical trials of 7 new drugs (excluding supplementary applications), of which 5 are Class 1 new drugs, and SKB337 injection is currently undergoing phase I clinical trials
    .
     
      Kelun has been approved for clinical new drugs since 2021
      Source: China Drug Clinical Trial Publicity Library of Meinenet
     
      The SKB337 injection, which is undergoing phase I clinical trials for advanced solid tumor indications, is a new generation of bispecific antibodies for tumor immune checkpoints.
    This biantibody uses a symmetrical IgG1κ-scFv that can act on tumor cells and effector T cells at the same time
    .
    At present, no dual antibody drug with the same target has been approved for marketing in the world
    .
    Tumor tumor tumor
     
      Docetaxel for injection (albumin-binding type) and sildenafil citrate oral membrane are all improved new drugs
    .
    At present, the domestically marketed docetaxel preparation is docetaxel injection, which will be used in Chinese urban public hospitals , county-level public hospitals, urban community centers, township health centers (referred to as Chinese public medical institutions) and physical pharmacies in Chinese cities in 2020.
    The sales scale of the terminal exceeds 3.
    5 billion yuan
    .
    Hospital hospital hospital pharmacy pharmacy pharmacy
     
      At present, the domestically marketed sildenafil preparations mainly include sildenafil citrate tablets and sildenafil citrate orally disintegrating tablets.
    In 2020, the sales scale of sildenafil citrate and sildenafil citrate in Chinese public medical institutions and physical pharmacies in Chinese cities will exceed 2.
    5 billion yuan, of which Chinese urban physical pharmacies are the main "battlefield", with sales accounting for more than 95%
    .
     
      The sales of sildenafil at physical drugstores in cities in China (unit: ten thousand yuan)
      Source: Mi Nei.
    com, China's urban physical pharmacy terminal competition pattern
     
      KL280006 injection is a peripheral κ opioid receptor (KOR) agonist, intended to treat uremia and itching
    .
    No similar compound has been approved for marketing in the world.
    The drug under development with the leading research and development progress is Cara Therapeutics' KORSUVA, and it has submitted a marketing application to the FDA
    .
     
      KL590586 capsule is a small molecule selective targeting RET kinase inhibitor.
    It is intended to treat advanced solid tumors with RET fusion or mutation.
    It is the first pan-tumor precision treatment drug developed by Kelun Pharmaceutical
    .
    In May 2020, the targeted anti-cancer drug Retevmo of Loxo Oncology, a subsidiary of Eli Lilly, was approved by the FDA for marketing, becoming the first approved therapeutic drug for cancer patients carrying RET genetic changes
    .
     
      Source: Mynet database, public company announcements, etc.
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