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    Home > Medical News > Latest Medical News > The first imitation of tens of billions of blockbuster varieties is declared for listing, and the market is fierce

    The first imitation of tens of billions of blockbuster varieties is declared for listing, and the market is fierce

    • Last Update: 2021-04-18
    • Source: Internet
    • Author: User
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    Medical Network News on April 13 
     
    Ten billion market, the first imitation is nearly
     
    Recently, CDE's official website showed that Simcere's application for the listing of Ibrutinib capsules was officially accepted by the State Food and Drug Administration, becoming the first generic drug of Ibrutinib submitted for marketing in China, and it is expected to realize the first imitation.
    Under the basic background of accelerating the replacement of the original research by the first generic drug in China and reducing the cost of the drug, once it goes on the market, it will definitely have a greater impact on the market of the original research.
     
    Ibruvica is the world's first BTK inhibitor to be marketed.
    It was jointly developed by Johnson & Johnson and Pharmacyclics (a subsidiary of AbbVie).
    It was approved by the FDA for listing in November 2013 under the trade name "Imbruvica".
    So far, Ibrutinib has been approved in more than 80 countries and regions.
     
    As a highly effective and highly selective small molecule inhibitor, ibrutinib is suitable for patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma and mantle cell lymphoma (MCL) who have received at least one treatment in the past.
    Therapeutics, sales have increased rapidly after it went on the market.
     
    According to a report on the world’s best-selling drugs, in 2014, the sales of ibrutinib reached US$692 million in the following year, US$1.
    443 billion in 2015, US$3.
    083 billion in 2016, US$4.
    446 billion in 2017, and US$4.
    446 billion in 2018.
    It is 6.
    205 billion U.
    S.
    dollars, 8.
    085 billion U.
    S.
    dollars in 2019, and 9.
    442 billion U.
    S.
    dollars in 2020.
     
    In the domestic market, Ibrutinib's performance is equally eye-catching.
     
    In 2017, Johnson & Johnson's ibrutinib was approved by the State Food and Drug Administration to be listed in China (the product name is "Yike", the dosage form is capsule, the specification is 140mg).
    After entering the hospital market, sales have grown rapidly.
    In 2018, after the medical insurance negotiation, the price was significantly reduced.
    It is fast and heavy.
    The price has been reduced from the original 48,600 yuan/box to 17,010 yuan/box.
    According to data from Mi Nei.
    com, sales increased from 44.
    42 million in 2018 to 557.
    17 million in 2019.
    Under the influence of the epidemic, sales will continue to rise in 2020, reaching 615.
    82 million in the first half of the year alone.
     
      
      (Data source: Mi Nei.
    com)
     
      intense market competition
     
      BTK is a popular research target in recent years.
    Although there are not many drugs approved at present, there are already some drugs that have entered clinical phase III trials, and there are many drugs in clinical phase II and phase I trials.
    It can be foreseen in the future.
    Will face great market competition.
     
      At present, 5 BTK inhibitors have been approved globally, namely, Johnson & Johnson's ibrutinib, BeiGene's zebutinib, Nuocheng Jianhua's abutinib, AstraZeneca's acatinib, and Ono Pharmaceutical Tirabrutinib.
    The first three have been approved for listing in the country.
    Among them, Nuocheng Jianhua's abutinib and BeiGene's zebutinib are conditionally approved for listing.
     
      It is worth noting that although the market size is nearly 10 billion, the market share is basically dominated by Johnson & Johnson's ibrutinib, but the newly approved drugs, such as zebutinib and obetinib, which will be launched in 2020, may be more excellent.
    The selectivity and further better efficacy and safety gradually occupy the market and compete with Ibrutinib.
     
      According to Fengshuo Ventures' comprehensive clinical data analysis, Zebutinib has optimized its chemical structure on the basis of Ibrutinib.
    It has higher BTK target selectivity and deeper inhibition, which can minimize off-target.
    On this basis, abutinib also showed a significantly higher rate of complete remission.
     
      In addition to clinical manifestations, the price competition for BTK inhibitors is also fierce.
     
      Currently, both ibrutinib and zebutinib have entered the national medical insurance, and their agreement is valid from March 1, 2021 to December 31, 2022.
    The medical insurance price of Zebutinib is 99 yuan (80mg/capsule), and the monthly treatment cost is about 13 thousand, which is more advantageous than the monthly treatment cost of ibritinib of 17,000.
     
      According to a recent article published by Nature reviews Drug Discovery (2021 Volume 20, Issue 1, Page 10), the market for ibrutinib in 2021 may fall back to around US$7 billion.
     
      In terms of indications, according to Fengshuo Ventures, the current indications for BTK are concentrated in the subspecies of B-cell lymphoma such as mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, etc.
    In addition, the indications for BTK research have also Various immune system diseases , such as rheumatoid arthritis, systemic lupus erythematosus, lupus nephritis, psoriasis, etc.
     
      It is worth noting that because the current rate of BTK resistance is relatively low, drugs that have been used in the market can continue to be used for a longer period of time.
    Under the fierce competition, follow-up drugs have already competed for the corresponding tumor market.
    Difficulty, it is necessary to actively explore other indications to obtain an ideal market return.
     
      It is understood that there are currently as many as 9 domestic manufacturers developing ibrutinib generic drugs.
    In addition to Simcere, which has already declared for listing, Chia Tai Tianqing, Hisun Pharmaceuticals, Shanghai Huilun, etc.
    have approved clinical trials and are conducting clinical studies.
    .
    Medical Network News on April 13 
     
      Ten billion market, the first imitation is nearly
     
      Recently, CDE's official website showed that Simcere's application for the listing of Ibrutinib capsules was officially accepted by the State Food and Drug Administration, becoming the first generic drug of Ibrutinib submitted for marketing in China, and it is expected to realize the first imitation.
    Under the basic background of accelerating the replacement of the original research by the first generic drug in China and reducing the cost of the drug, once it goes on the market, it will definitely have a greater impact on the market of the original research.
     
      Ibruvica is the world's first BTK inhibitor to be marketed.
    It was jointly developed by Johnson & Johnson and Pharmacyclics (a subsidiary of AbbVie).
    It was approved by the FDA for listing in November 2013 under the trade name "Imbruvica".
    So far, Ibrutinib has been approved in more than 80 countries and regions.
     
      As a highly effective and highly selective small molecule inhibitor, ibrutinib is suitable for patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma and mantle cell lymphoma (MCL) who have received at least one treatment in the past.
    Therapeutics, sales have increased rapidly after it went on the market.
     
      According to a report on the world’s best-selling drugs, in 2014, the sales of ibrutinib reached US$692 million in the following year, US$1.
    443 billion in 2015, US$3.
    083 billion in 2016, US$4.
    446 billion in 2017, and US$4.
    446 billion in 2018.
    It is 6.
    205 billion U.
    S.
    dollars, 8.
    085 billion U.
    S.
    dollars in 2019, and 9.
    442 billion U.
    S.
    dollars in 2020.
     
      In the domestic market, Ibrutinib's performance is equally eye-catching.
     
      In 2017, Johnson & Johnson's ibrutinib was approved by the State Food and Drug Administration to be listed in China (the product name is "Yike", the dosage form is capsule, the specification is 140mg).
    After entering the hospital market, sales have grown rapidly.
    In 2018, after the medical insurance negotiation, the price was significantly reduced.
    It is fast and heavy.
    The price has been reduced from the original 48,600 yuan/box to 17,010 yuan/box.
    According to data from Mi Nei.
    com, sales increased from 44.
    42 million in 2018 to 557.
    17 million in 2019.
    Under the influence of the epidemic, sales will continue to rise in 2020, reaching 615.
    82 million in the first half of the year alone.
     
      
      (Data source: Mi Nei.
    com)
     
      intense market competition
     
      BTK is a popular research target in recent years.
    Although there are not many drugs approved at present, there are already some drugs that have entered clinical phase III trials, and there are many drugs in clinical phase II and phase I trials.
    It can be foreseen in the future.
    Will face great market competition.
     
      At present, 5 BTK inhibitors have been approved globally, namely, Johnson & Johnson's ibrutinib, BeiGene's zebutinib, Nuocheng Jianhua's abutinib, AstraZeneca's acatinib, and Ono Pharmaceutical Tirabrutinib.
    The first three have been approved for listing in the country.
    Among them, Nuocheng Jianhua's abutinib and BeiGene's zebutinib are conditionally approved for listing.
     
      It is worth noting that although the market size is nearly 10 billion, the market share is basically dominated by Johnson & Johnson's ibrutinib, but the newly approved drugs, such as zebutinib and obetinib, which will be launched in 2020, may be more excellent.
    The selectivity and further better efficacy and safety gradually occupy the market and compete with Ibrutinib.
     
      According to Fengshuo Ventures' comprehensive clinical data analysis, Zebutinib has optimized its chemical structure on the basis of Ibrutinib.
    It has higher BTK target selectivity and deeper inhibition, which can minimize off-target.
    On this basis, abutinib also showed a significantly higher rate of complete remission.
     
      In addition to clinical manifestations, the price competition for BTK inhibitors is also fierce.
     
      Currently, both ibrutinib and zebutinib have entered the national medical insurance, and their agreement is valid from March 1, 2021 to December 31, 2022.
    The medical insurance price of Zebutinib is 99 yuan (80mg/capsule), and the monthly treatment cost is about 13 thousand, which is more advantageous than the monthly treatment cost of ibritinib of 17,000.
     
      According to a recent article published by Nature reviews Drug Discovery (2021 Volume 20, Issue 1, Page 10), the market for ibrutinib in 2021 may fall back to around US$7 billion.
     
      In terms of indications, according to Fengshuo Ventures, the current indications for BTK are concentrated in the subspecies of B-cell lymphoma such as mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, etc.
    In addition, the indications for BTK research have also Various immune system diseases , such as rheumatoid arthritis, systemic lupus erythematosus, lupus nephritis, psoriasis, etc.
     
      It is worth noting that because the current rate of BTK resistance is relatively low, drugs that have been used in the market can continue to be used for a longer period of time.
    Under the fierce competition, follow-up drugs have already competed for the corresponding tumor market.
    Difficulty, it is necessary to actively explore other indications to obtain an ideal market return.
     
      It is understood that there are currently as many as 9 domestic manufacturers developing ibrutinib generic drugs.
    In addition to Simcere, which has already declared for listing, Chia Tai Tianqing, Hisun Pharmaceuticals, Shanghai Huilun, etc.
    have approved clinical trials and are conducting clinical studies.
    .
    Medical Network News on April 13 
     
      Ten billion market, the first imitation is nearly
      Ten billion market, the first imitation is nearly
     
      Recently, CDE's official website showed that Simcere's application for the listing of Ibrutinib capsules was officially accepted by the State Food and Drug Administration, becoming the first generic drug of Ibrutinib submitted for marketing in China, and it is expected to realize the first imitation.
    Under the basic background of accelerating the replacement of the original research by the first generic drug in China and reducing the cost of the drug, once it goes on the market, it will definitely have a greater impact on the market of the original research.
     
      Ibruvica is the world's first BTK inhibitor to be marketed.
    It was jointly developed by Johnson & Johnson and Pharmacyclics (a subsidiary of AbbVie).
    It was approved by the FDA for listing in November 2013 under the trade name "Imbruvica".
    So far, Ibrutinib has been approved in more than 80 countries and regions.
     
      As a highly effective and highly selective small molecule inhibitor, ibrutinib is suitable for patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma and mantle cell lymphoma (MCL) who have received at least one treatment in the past.
    Therapeutics, sales have increased rapidly after it went on the market.
     
      According to a report on the world’s best-selling drugs, in 2014, the sales of ibrutinib reached US$692 million in the following year, US$1.
    443 billion in 2015, US$3.
    083 billion in 2016, US$4.
    446 billion in 2017, and US$4.
    446 billion in 2018.
    It is 6.
    205 billion U.
    S.
    dollars, 8.
    085 billion U.
    S.
    dollars in 2019, and 9.
    442 billion U.
    S.
    dollars in 2020.
     
      In the domestic market, Ibrutinib's performance is equally eye-catching.
     
      In 2017, Johnson & Johnson's ibrutinib was approved by the State Food and Drug Administration to be listed in China (the product name is "Yike", the dosage form is capsule, the specification is 140mg).
    After entering the hospital market, sales have grown rapidly.
    In 2018, after the medical insurance negotiation, the price was significantly reduced.
    It is fast and heavy.
    The price has been reduced from the original 48,600 yuan/box to 17,010 yuan/box.
    According to data from Mi Nei.
    com, sales increased from 44.
    42 million in 2018 to 557.
    17 million in 2019.
    Under the influence of the epidemic, sales will continue to rise in 2020, reaching 615.
    82 million in the first half of the year alone.
    Hospital hospital hospital
     
      
      (Data source: Mi Nei.
    com)
     
      intense market competition
      intense market competition
     
      BTK is a popular research target in recent years.
    Although there are not many drugs approved at present, there are already some drugs that have entered clinical phase III trials, and there are many drugs in clinical phase II and phase I trials.
    It can be foreseen in the future.
    Will face great market competition.
     
      At present, 5 BTK inhibitors have been approved globally, namely, Johnson & Johnson's ibrutinib, BeiGene's zebutinib, Nuocheng Jianhua's abutinib, AstraZeneca's acatinib, and Ono Pharmaceutical Tirabrutinib.
    The first three have been approved for listing in the country.
    Among them, Nuocheng Jianhua's abutinib and BeiGene's zebutinib are conditionally approved for listing.
     
      It is worth noting that although the market size is nearly 10 billion, the market share is basically dominated by Johnson & Johnson's ibrutinib, but the newly approved drugs, such as zebutinib and obetinib, which will be launched in 2020, may be more excellent.
    The selectivity and further better efficacy and safety gradually occupy the market and compete with Ibrutinib.
     
      According to Fengshuo Ventures' comprehensive clinical data analysis, Zebutinib has optimized its chemical structure on the basis of Ibrutinib.
    It has higher BTK target selectivity and deeper inhibition, which can minimize off-target.
    On this basis, abutinib also showed a significantly higher rate of complete remission.
     
      In addition to clinical manifestations, the price competition for BTK inhibitors is also fierce.
     
      Currently, both ibrutinib and zebutinib have entered the national medical insurance, and their agreement is valid from March 1, 2021 to December 31, 2022.
    The medical insurance price of Zebutinib is 99 yuan (80mg/capsule), and the monthly treatment cost is about 13 thousand, which is more advantageous than the monthly treatment cost of ibritinib of 17,000.
     
      According to a recent article published by Nature reviews Drug Discovery (2021 Volume 20, Issue 1, Page 10), the market for ibrutinib in 2021 may fall back to around US$7 billion.
     
      In terms of indications, according to Fengshuo Ventures, the current indications for BTK are concentrated in the subspecies of B-cell lymphoma such as mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, etc.
    In addition, the indications for BTK research have also Various immune system diseases , such as rheumatoid arthritis, systemic lupus erythematosus, lupus nephritis, psoriasis, etc.
    Disease disease disease
     
      It is worth noting that because the current rate of BTK resistance is relatively low, drugs that have been used in the market can continue to be used for a longer period of time.
    Under the fierce competition, follow-up drugs have already competed for the corresponding tumor market.
    Difficulty, it is necessary to actively explore other indications to obtain an ideal market return.
    Tumor tumor tumor
     
      It is understood that there are currently as many as 9 domestic manufacturers developing ibrutinib generic drugs.
    In addition to Simcere, which has already declared for listing, Chia Tai Tianqing, Hisun Pharmaceuticals, Shanghai Huilun, etc.
    have approved clinical trials and are conducting clinical studies.
    .
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