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    Home > Medical News > Latest Medical News > Domestic heavy-weight new drugs have been approved, innovative drug product selection is the key!

    Domestic heavy-weight new drugs have been approved, innovative drug product selection is the key!

    • Last Update: 2021-03-22
    • Source: Internet
    • Author: User
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    60。,B(BLyS)(APRIL)。
     
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    ,(GSK)(belimumab),BLyS。2019,SLE,201979,040。
     
    (systemic lupus erythematosus,SLE),、,。
     
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    8%8108。
     
    ,,SLE,。
     
     
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    252019609.
    60,14.
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      It can be seen that China’s pharmaceutical industry already has the foundation for innovation.
    Both talents and capital can support the advancement of China’s pharmaceutical industry to a higher level.
    However, it is worth noting that there are still some in my country’s innovative drug industry.
    problem.
     
      Taking PD-1 as an example, the brand-new target, outstanding therapeutic effect, and excellent market performance have all proved that PD-1 is undoubtedly a very good innovative drug.
    However, there are currently 8 PD-1/PD-L1 listed in China, and 15 PD1/PDL1 monoclonal antibodies have applied for listing.
    In addition, there are nearly 200 PD-1 related clinical trials, which can be foreseen The future competition pattern of PD1 is not optimistic.
    Sun Piaoyang, a representative of the National People's Congress and chairman of Jiangsu Hengrui Pharmaceutical Group Co.
    , Ltd.
    , also mentioned the problem of getting together on the PD-1 track a few days ago.
     
      This situation is not only a waste of production capacity, which is not conducive to the development of innovative drugs in China.
    On the other hand, for companies, if the product is not innovative and does not form enough barriers to protect, it is likely to cause competition for products that have just been launched.
    The situation has deteriorated, and products have entered the road of price reduction and centralized procurement.
     
      China does not lack the ability to innovate, and what it lacks is the direction of innovation.
    Enterprises should seize the current window of innovation under the support of valuable policies, quickly improve their innovation capabilities, and continue to introduce barriers and difficult-to-copy products.
     
      Recently, the Pharmaceutical Research and Development Industry Committee (RDPAC) of the China Association of Enterprises with Foreign Investment released the "Jointly Innovative Medicine Industry to Help the Construction of a Healthy China".
    The report predicts that future R&D and innovation will rely on ten breakthrough technologies to enter the medical field.
     
      Among them, the five technological revolutions of omics and molecular technology, next-generation pharmaceuticals, cell therapy and regenerative medicine, innovative vaccines and electronic drugs are closely related to drug therapy.
     
      In addition, at present, a number of first-in-class drugs that are relatively leading in the world have emerged in China, such as double antibodies, polyethylene glycol modification, CAR-T and other fields.
     
      It is believed that my country's innovative drug industry will develop better and better in the future.
      Medical Network, March 11, tens of billions market, the first domestically produced innovative drug approved
     
      Ten billion Blue Ocean Class 1 new drug approved
     
      Recently, Rongchang Bio-independently developed a new drug type 1 drug, the application status of the new drug testacept has been updated to "approval completed-pending certification", which means that this new drug has been officially approved in China.
    In addition, in April last year, the FDA also granted fast-track designation to testacept.
     
      Taltazep is the first domestically produced Chinese drug for the treatment of systemic lupus erythematosus that has been approved for marketing in China in more than 60 years.
    According to public information, Taltazep is a new type of recombinant fusion protein that simultaneously targets two important cell signaling molecules, B lymphocyte stimulating factor (BLyS) and proliferation-inducing ligand (APRIL).
     
      Overexpression of these two factors is an important cause of systemic lupus erythematosus and other B-lymphocyte-related autoimmune diseases, and has become an important target for autoimmune therapy.
    However, most of the clinical stage drug candidates for this signaling pathway are aimed at In one of the two.
     
      Tatacept's main domestic competitor in the future, belimumab of GlaxoSmithKline (GSK), is a humanized monoclonal antibody targeting BLyS.
    In 2019, belyumumab was approved by the China Food and Drug Administration for the treatment of SLE in China.
    In 2019, its estimated annual treatment cost in China under the patient assistance program is approximately RMB 79,040.
     
      Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with clinical manifestations of multi-system damage.
    It often leads to multi-organ and multi-system damage.
    It is a major life-threatening disease.
     
      According to Frost & Sullivan, the global SLE population in 2019 was approximately 7.
    7 million, and it is estimated that it will reach 8.
    6 million by 2030.
    In China, there are approximately 1 million SLE patients in 2019, and it is estimated that it will increase to approximately 1.
    1 million by 2030.
    According to Frost & Sullivan's data, it is estimated that the global SLE biotherapy market will grow at a compound annual growth rate of 26.
    8% from US$800 million in 2019 to US$10.
    8 billion in 2030.
     
      With such a large market prospect, considering that the clinical needs of SLE patients are still difficult to meet, the drug may achieve good market performance after it is launched.
     
      Innovative drugs, product selection is the key
     
      In the past two years, the policy orientation of the pharmaceutical industry has gradually shifted towards improving efficiency, eliminating excess production capacity, and encouraging innovation.
    Save the cost of medical insurance by purchasing in quantity, freeing up cages and changing birds for innovative drugs.
    At the same time, in terms of review and evaluation, the government has also increased green channels, and the review and listing of innovative drugs and entrepreneurial devices have been greatly accelerated.
     
      Since the state has focused on encouraging pharmaceutical innovation, more and more companies have begun to innovate and have invested heavily.
    The overall R&D expenditure of pharmaceutical manufacturing enterprises increased from 21.
    125 billion yuan in 2011 to 60.
    960 billion yuan in 2019, with a compound annual growth rate of 14.
    15%.
     
      In the three years from 2018 to 2020, domestic Class 1 new drugs have entered the harvest period, with a total of 32 listed.
    In terms of years, 9 Class 1 new drugs were approved in 2018 and 2019, and there will be a big outbreak in 2020, with 14 of them on the market.
     
      It can be seen that China’s pharmaceutical industry already has the foundation for innovation.
    Both talents and capital can support the advancement of China’s pharmaceutical industry to a higher level.
    However, it is worth noting that there are still some in my country’s innovative drug industry.
    problem.
     
      Taking PD-1 as an example, the brand-new target, outstanding therapeutic effect, and excellent market performance have all proved that PD-1 is undoubtedly a very good innovative drug.
    However, there are currently 8 PD-1/PD-L1 listed in China, and 15 PD1/PDL1 monoclonal antibodies have applied for listing.
    In addition, there are nearly 200 PD-1 related clinical trials, which can be foreseen The future competition pattern of PD1 is not optimistic.
    Sun Piaoyang, a representative of the National People's Congress and chairman of Jiangsu Hengrui Pharmaceutical Group Co.
    , Ltd.
    , also mentioned the problem of getting together on the PD-1 track a few days ago.
     
      This situation is not only a waste of production capacity, which is not conducive to the development of innovative drugs in China.
    On the other hand, for companies, if the product is not innovative and does not form enough barriers to protect, it is likely to cause competition for products that have just been launched.
    The situation has deteriorated, and products have entered the road of price reduction and centralized procurement.
     
      China does not lack the ability to innovate, and what it lacks is the direction of innovation.
    Enterprises should seize the current window of innovation under the support of valuable policies, quickly improve their innovation capabilities, and continue to introduce barriers and difficult-to-copy products.
     
      Recently, the Pharmaceutical Research and Development Industry Committee (RDPAC) of the China Association of Enterprises with Foreign Investment released the "Jointly Innovative Medicine Industry to Help the Construction of a Healthy China".
    The report predicts that future R&D and innovation will rely on ten breakthrough technologies to enter the medical field.
     
      Among them, the five technological revolutions of omics and molecular technology, next-generation pharmaceuticals, cell therapy and regenerative medicine, innovative vaccines and electronic drugs are closely related to drug therapy.
     
      In addition, at present, a number of first-in-class drugs that are relatively leading in the world have emerged in China, such as double antibodies, polyethylene glycol modification, CAR-T and other fields.
     
      It is believed that my country's innovative drug industry will develop better and better in the future.
      Medical Network, March 11, tens of billions market, the first domestically produced innovative drug approved
      
     
      Ten billion Blue Ocean Class 1 new drug approved
      Ten billion Blue Ocean Class 1 new drug approved
     
      Recently, Rongchang Bio-independently developed a new drug type 1 drug, the application status of the new drug testacept has been updated to "approval completed-pending certification", which means that this new drug has been officially approved in China.
    In addition, in April last year, the FDA also granted fast-track designation to testacept.
     
      Taltazep is the first domestically produced Chinese drug for the treatment of systemic lupus erythematosus that has been approved for marketing in China in more than 60 years.
    According to public information, Taltazep is a new type of recombinant fusion protein that simultaneously targets two important cell signaling molecules, B lymphocyte stimulating factor (BLyS) and proliferation-inducing ligand (APRIL).
     
      Overexpression of these two factors is an important cause of systemic lupus erythematosus and other B-lymphocyte-related autoimmune diseases, and has become an important target for autoimmune therapy.
    However, most of the clinical stage drug candidates for this signaling pathway are aimed at In one of the two.
     
      Tatacept's main domestic competitor in the future, belimumab of GlaxoSmithKline (GSK), is a humanized monoclonal antibody targeting BLyS.
    In 2019, belyumumab was approved by the China Food and Drug Administration for the treatment of SLE in China.
    In 2019, its estimated annual treatment cost in China under the patient assistance program is approximately RMB 79,040.
     
      Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with clinical manifestations of multi-system damage.
    It often leads to multi-organ and multi-system damage.
    It is a major life-threatening disease.
     
      According to Frost & Sullivan, the global SLE population in 2019 was approximately 7.
    7 million, and it is estimated that it will reach 8.
    6 million by 2030.
    In China, there are approximately 1 million SLE patients in 2019, and it is estimated that it will increase to approximately 1.
    1 million by 2030.
    According to Frost & Sullivan's data, it is estimated that the global SLE biotherapy market will grow at a compound annual growth rate of 26.
    8% from US$800 million in 2019 to US$10.
    8 billion in 2030.
     
      With such a large market prospect, considering that the clinical needs of SLE patients are still difficult to meet, the drug may achieve good market performance after it is launched.
     
      Innovative drugs, product selection is the key
      Innovative drugs, product selection is the key
     
      In the past two years, the policy orientation of the pharmaceutical industry has gradually shifted towards improving efficiency, eliminating excess production capacity, and encouraging innovation.
    Save the cost of medical insurance by purchasing in quantity, freeing up cages and changing birds for innovative drugs.
    At the same time, in terms of review and evaluation, the government has also increased green channels, and the review and listing of innovative drugs and entrepreneurial devices have been greatly accelerated.
    Medicine medicine medicine entrepreneurial business venture
     
      Since the state has focused on encouraging pharmaceutical innovation, more and more companies have begun to innovate and have invested heavily.
    The overall R&D expenditure of pharmaceutical manufacturing enterprises increased from 21.
    125 billion yuan in 2011 to 60.
    960 billion yuan in 2019, with a compound annual growth rate of 14.
    15%.
    Enterprise business enterprise
     
      In the three years from 2018 to 2020, domestic Class 1 new drugs have entered the harvest period, with a total of 32 listed.
    In terms of years, 9 Class 1 new drugs were approved in 2018 and 2019, and there will be a big outbreak in 2020, with 14 of them on the market.
     
      It can be seen that China’s pharmaceutical industry already has the foundation for innovation.
    Both talents and capital can support the advancement of China’s pharmaceutical industry to a higher level.
    However, it is worth noting that there are still some in my country’s innovative drug industry.
    problem.
     
      Taking PD-1 as an example, the brand-new target, outstanding therapeutic effect, and excellent market performance have all proved that PD-1 is undoubtedly a very good innovative drug.
    However, there are currently 8 PD-1/PD-L1 listed in China, and 15 PD1/PDL1 monoclonal antibodies have applied for listing.
    In addition, there are nearly 200 PD-1 related clinical trials, which can be foreseen The future competition pattern of PD1 is not optimistic.
    Sun Piaoyang, a representative of the National People's Congress and chairman of Jiangsu Hengrui Pharmaceutical Group Co.
    , Ltd.
    , also mentioned the problem of getting together on the PD-1 track a few days ago.
     
      This situation is not only a waste of production capacity, which is not conducive to the development of innovative drugs in China.
    On the other hand, for companies, if the product is not innovative and does not form enough barriers to protect, it is likely to cause competition for products that have just been launched.
    The situation has deteriorated, and products have entered the road of price reduction and centralized procurement.
     
      China does not lack the ability to innovate, and what it lacks is the direction of innovation.
    Enterprises should seize the current window of innovation under the support of valuable policies, quickly improve their innovation capabilities, and continue to introduce barriers and difficult-to-copy products.
     
      Recently, the Pharmaceutical Research and Development Industry Committee (RDPAC) of the China Association of Enterprises with Foreign Investment released the "Jointly Innovative Medicine Industry to Help the Construction of a Healthy China".
    The report predicts that future R&D and innovation will rely on ten breakthrough technologies to enter the medical field.
    Medicine medicine medicine health healthy health
     
      Among them, the five technological revolutions of omics and molecular technology, next-generation pharmaceuticals, cell therapy and regenerative medicine, innovative vaccines and electronic drugs are closely related to drug therapy.
     
      In addition, at present, a number of first-in-class drugs that are relatively leading in the world have emerged in China, such as double antibodies, polyethylene glycol modification, CAR-T and other fields.
     
      It is believed that my country's innovative drug industry will develop better and better in the future.
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