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414 ，、“”，。，4，，？，1，？，。
20，1
1：2020
：
，2020，20%，，，9%，65。，，，？
1：2021（）
：MED2.
0
0
Since 2021, a total of 20 new antithrombotic drugs (according to product name + company statistics) have been approved for marketing.
Except for Nanjing Xingyin Pharmaceutical Group's bivalrudine for injection, which has been approved for 6 types of imitations, the remaining 19 products are considered the same After review, Zhaoke Pharmaceutical (Hefei) is the first company to review Fondaparinux Sodium Injection.
Except for Nanjing Xingyin Pharmaceutical Group's bivalrudine for injection, which has been approved for 6 types of imitations, the remaining 19 products are considered the same After review, Zhaoke Pharmaceutical (Hefei) is the first company to review Fondaparinux Sodium Injection.
Figure 2: The status of new class 1 antithrombotic drugs approved for clinical use in 2021
Source: CDE official website
In terms of Class 1 new drugs, Xinlitai announced on March 31, 2021 that the company's SAL0104 capsule was approved for clinical use.
The product is a factor XIa inhibitor, and its intended development indication is the prevention and treatment of thrombotic diseases.
This is the first Class 1 new drug approved for clinical use in this field so far this year, and it is also one of Xinlitai's key research and development products.
The product is a factor XIa inhibitor, and its intended development indication is the prevention and treatment of thrombotic diseases.
This is the first Class 1 new drug approved for clinical use in this field so far this year, and it is also one of Xinlitai's key research and development products.
Xinlitai, the domestic leader in antithrombotic drugs, was ranked behind Sanofi in public hospitals in key provinces and cities in 2013-2017, occupying the TOP2 position.
Since 2018, the country started to pharmnet.
com.
cn/news/yyzb/" target="_blank">purchase in quantity .
Antithrombotic drugs frequently appear in the catalog as commonly used clinical drugs.
After the market has been reshuffled, the ranking of enterprises has also changed.
In 2020, Xinlitai is only ranked in the TOP5.
Generic drugs can hardly escape the situation of centralized procurement and price reduction.
Innovative drugs are the future of the company.
Xinlitai is currently in the stage of continuous transformation from a generic drug company to an innovative drug company.
SAL0104 capsules are the company's new breakthrough in the field of antithrombotic drugs.
.
Since 2018, the country started to pharmnet.
com.
cn/news/yyzb/" target="_blank">purchase in quantity .
Antithrombotic drugs frequently appear in the catalog as commonly used clinical drugs.
After the market has been reshuffled, the ranking of enterprises has also changed.
In 2020, Xinlitai is only ranked in the TOP5.
Generic drugs can hardly escape the situation of centralized procurement and price reduction.
Innovative drugs are the future of the company.
Xinlitai is currently in the stage of continuous transformation from a generic drug company to an innovative drug company.
SAL0104 capsules are the company's new breakthrough in the field of antithrombotic drugs.
.
The fate of nationally sourced varieties is very different, the former TOP1 products plummeted by more than 60%
Table 2: Sales growth rate of antithrombotic drugs included in the national procurement in the past three years
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
Among the TOP10 products of terminal antithrombotic drugs in public hospitals in key provinces and cities from 2015 to 2018, clopidogrel bisulfate tablets firmly held the top spot with sales of over 2 billion yuan, and was included in the first batch (4+7, alliance expansion).
(Wei) After the national mining, sales fell precipitously for two consecutive years.
In 2019, it fell to 1.
7 billion yuan but still ranked first.
In 2020, only 660 million yuan is left, which was won by rivaroxaban with a sales of 960 million yuan.
Championship throne.
(Wei) After the national mining, sales fell precipitously for two consecutive years.
In 2019, it fell to 1.
7 billion yuan but still ranked first.
In 2020, only 660 million yuan is left, which was won by rivaroxaban with a sales of 960 million yuan.
Championship throne.
Figure 3: Competitive landscape of clopidogrel bisulfate tablets enterprises
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
Clopidogrel bisulfate tablets can be regarded as an old variety of antithrombotic drugs.
The original research product entered the Chinese market in 2001, but as early as 2000, the domestic pharmaceutical company Xin Litai obtained the second-class new drug certificate and production approval.
The patent of the original research drug expired in 2012.
Prior to this, the market had been divided by Sanofi and Xinlitai.
It is not easy for the subsequent approved generic drugs to grab the market.
In 2018, the first batch of national sourcing companies took a fancy to this heavy variety.
In order to maintain their market position, Xinlitai and Sanofi joined the price reduction war one after another: in the first batch (4+7) of national sourcing, Xinlitai Exclusively won the bid, a decrease of 58%; during the alliance expansion stage, Sanofi's price was 20% lower than the winning bid of Xinlitai 4+7, showing full sincerity.
Guocai helps the market reshuffle.
Lepu’s market share in 2020 will be more than 10%, while CSPC will also occupy 7%, Sanofi will remain at half of the country, and Xinlitai will remain at around 30%.
The original research product entered the Chinese market in 2001, but as early as 2000, the domestic pharmaceutical company Xin Litai obtained the second-class new drug certificate and production approval.
The patent of the original research drug expired in 2012.
Prior to this, the market had been divided by Sanofi and Xinlitai.
It is not easy for the subsequent approved generic drugs to grab the market.
In 2018, the first batch of national sourcing companies took a fancy to this heavy variety.
In order to maintain their market position, Xinlitai and Sanofi joined the price reduction war one after another: in the first batch (4+7) of national sourcing, Xinlitai Exclusively won the bid, a decrease of 58%; during the alliance expansion stage, Sanofi's price was 20% lower than the winning bid of Xinlitai 4+7, showing full sincerity.
Guocai helps the market reshuffle.
Lepu’s market share in 2020 will be more than 10%, while CSPC will also occupy 7%, Sanofi will remain at half of the country, and Xinlitai will remain at around 30%.
At present, there are 10 companies that have reviewed clopidogrel bisulfate tablets (including deemed review), and 4 domestic pharmaceutical companies such as Dongyang Pharmaceutical and Yangzijiang have declared 4 types of imitations and are under review.
As follow-up products are successively approved After approval and review, more and more companies will have the opportunity to participate in the renewal bidding, and the price may continue to fall.
As follow-up products are successively approved After approval and review, more and more companies will have the opportunity to participate in the renewal bidding, and the price may continue to fall.
Figure 4: The competitive landscape of Apixaban tablets in 2020
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
Apixaban tablets were approved to enter the domestic market in 2013 and entered the National Medical Insurance Catalogue since 2017.
The growth rate of terminal sales in public hospitals in key provinces and cities exceeded 50% from 2017 to 2018.
In 2019, Hausen won the first imitation, and then Chia Tai Tianqing Pharmaceutical Group and Kelun were successively approved in the same year.
Up to now, 11 domestic pharmaceutical companies have been approved and reviewed.
After the listing of domestic generic drugs, the overall sales of the product have been greatly improved.
The sales growth rate of Hausen in 2020 will exceed 621%, and the Chia Tai Tianqing Pharmaceutical Group will reach 1406%.
At present, apixaban tablets are in the high-speed and high-volume stage.
The third batch of national procurement will be implemented in the fourth quarter of 2020.
With the rapid production of products from the winning bidders (Qilu, Hausen, Zhengda Tianqing Pharmaceutical Group, Jiangsu Jiayi Pharmaceutical ) Entering the hospital, the overall sales scale of the product is expected to rise again in 2021, while the market share of the original research drug may decline again.
The growth rate of terminal sales in public hospitals in key provinces and cities exceeded 50% from 2017 to 2018.
In 2019, Hausen won the first imitation, and then Chia Tai Tianqing Pharmaceutical Group and Kelun were successively approved in the same year.
Up to now, 11 domestic pharmaceutical companies have been approved and reviewed.
After the listing of domestic generic drugs, the overall sales of the product have been greatly improved.
The sales growth rate of Hausen in 2020 will exceed 621%, and the Chia Tai Tianqing Pharmaceutical Group will reach 1406%.
At present, apixaban tablets are in the high-speed and high-volume stage.
The third batch of national procurement will be implemented in the fourth quarter of 2020.
With the rapid production of products from the winning bidders (Qilu, Hausen, Zhengda Tianqing Pharmaceutical Group, Jiangsu Jiayi Pharmaceutical ) Entering the hospital, the overall sales scale of the product is expected to rise again in 2021, while the market share of the original research drug may decline again.
Table 3: Products that have been reviewed but not purchased by the country
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Fifth country adopted in full swing, the current has passed assessment of antithrombotic drugs a total of 12 products, which has passed assessment of rivaroxaban tablets enterprises reached 14, in addition, dabigatran etexilate capsules, tirofiban hydrochloride Ban Sodium Chloride Injection has also formed a pattern of "original research + 3 imitation".
Will these three varieties be favored by the national mining company? We will wait and see.
Will these three varieties be favored by the national mining company? We will wait and see.
12 over 100 million varieties, 7 of which are controlled by multinational pharmaceutical companies
Table 4: Antithrombotic drugs with sales exceeding 100 million yuan in 2020
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
In the public hospitals of key provinces and cities , among the large varieties of antithrombotic drugs with sales of over 100 million in 2019, the sales of Ureklin and Tirofiban fell by 28.
19% and 9.
38% respectively in 2020, and both fell out of 2020.
The 100 million yuan list.
19% and 9.
38% respectively in 2020, and both fell out of 2020.
The 100 million yuan list.
From the perspective of market leadership, 7 of the 12 varieties with more than 100 million yuan have been "kings" by multinational pharmaceutical companies, including rivaroxaban, ticagrelor, dabigatran etexilate, aspirin (acetylsalicylic acid), The market share of Alteplase original research drug companies is as high as 90%, and domestic high-end generic drugs must work harder to replace the original research.
Ticagrelor has been included in the national procurement, 6 domestic pharmaceutical companies won the bid, AstraZeneca’s share decline is a high probability event; rivaroxaban and dabigatran etexilate are expected to enter the next batch of catalogues, if included, Bayer and What kind of floor price will Boehringer Ingelheim offer to maintain its market position?
Table 5: Consistency evaluation of aspirin currently under review
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Aspirin is a traditional drug among anti-platelet aggregation drugs.
Due to the low price of the original research drug and the category of medical insurance, the cost-effective advantage of domestic generic drugs is not obvious, resulting in the dominant situation of the original research drug company.
Currently, no domestic pharmaceutical companies have applied for the generic listing of Category 3 and Category 4, but the consistency evaluation of aspirin enteric-coated tablets of Guilin Pharmaceutical and Chenxin Pharmaceutical is under review and approval, and there is still market space for over-evaluated products to replace the original drug.
Due to the low price of the original research drug and the category of medical insurance, the cost-effective advantage of domestic generic drugs is not obvious, resulting in the dominant situation of the original research drug company.
Currently, no domestic pharmaceutical companies have applied for the generic listing of Category 3 and Category 4, but the consistency evaluation of aspirin enteric-coated tablets of Guilin Pharmaceutical and Chenxin Pharmaceutical is under review and approval, and there is still market space for over-evaluated products to replace the original drug.
Alteplase is a recombinant tissue-type plasminogen activator, which can prevent thrombosis and enlargement.
It is the most commonly used thrombolytic agent for the treatment of acute myocardial infarction, cerebral infarction and pulmonary embolism.
At present, only Boehringer Ingelheim is produced and sold in the domestic market.
No domestic pharmaceutical companies have applied for imitation and listing.
The original drug entered the 2009 version of the National Medical Insurance Catalog.
Thrombolysis is limited to within 12 hours of acute myocardial infarction and within 3 hours of cerebral infarction.
For treatment, the price was reduced during the 2020 medical insurance negotiations, but the payment price was not disclosed to the public.
It is the most commonly used thrombolytic agent for the treatment of acute myocardial infarction, cerebral infarction and pulmonary embolism.
At present, only Boehringer Ingelheim is produced and sold in the domestic market.
No domestic pharmaceutical companies have applied for imitation and listing.
The original drug entered the 2009 version of the National Medical Insurance Catalog.
Thrombolysis is limited to within 12 hours of acute myocardial infarction and within 3 hours of cerebral infarction.
For treatment, the price was reduced during the 2020 medical insurance negotiations, but the payment price was not disclosed to the public.
Conclusion
Cardiovascular and cerebrovascular diseases caused by thrombosis are a common disease that seriously threatens humans, especially among middle-aged and elderly people over 50.
With the accelerating aging of our country, the proportion of the affected population in the society is also increasing.
.
On the one hand, with the help of Guocai, domestic high-end generic drugs will have the opportunity to start a head-to-head confrontation with the original research drug.
On the other hand, the research and development results of domestic new drugs are gradually being introduced to the market.
With the continuous efforts of domestic pharmaceutical companies , The era when the antithrombotic drug market is dominated by multinational pharmaceutical companies will eventually come to an end.
With the accelerating aging of our country, the proportion of the affected population in the society is also increasing.
.
On the one hand, with the help of Guocai, domestic high-end generic drugs will have the opportunity to start a head-to-head confrontation with the original research drug.
On the other hand, the research and development results of domestic new drugs are gradually being introduced to the market.
With the continuous efforts of domestic pharmaceutical companies , The era when the antithrombotic drug market is dominated by multinational pharmaceutical companies will eventually come to an end.
Source: Minet database, CDE official website, company announcement
The review data statistics are as of April 13, if there are any errors or omissions, please correct me.
According to data from Meinenet.
com on April 14, Yuandong Bio's dabigatran etexilate capsules and Qianjin Pharmaceutical's apixaban tablets have entered the "under approval" status, and the antithrombotic drug market is expected to add new competition.
By.
The fifth batch of national procurement is like an arrow.
Four antithrombotic drugs have been included in the previous four batches and five rounds.
Among them, the sales of apixaban tablets have soared for three consecutive years.
What are the next batch of nationally-produced hot products? Earlier, the leading domestic pharmaceutical company Xin Litai's anti-thrombotic Class 1 new drug was approved for clinical use.
What is so outstanding about this innovative drug? Next, we analyze one by one.
com on April 14, Yuandong Bio's dabigatran etexilate capsules and Qianjin Pharmaceutical's apixaban tablets have entered the "under approval" status, and the antithrombotic drug market is expected to add new competition.
By.
The fifth batch of national procurement is like an arrow.
Four antithrombotic drugs have been included in the previous four batches and five rounds.
Among them, the sales of apixaban tablets have soared for three consecutive years.
What are the next batch of nationally-produced hot products? Earlier, the leading domestic pharmaceutical company Xin Litai's anti-thrombotic Class 1 new drug was approved for clinical use.
What is so outstanding about this innovative drug? Next, we analyze one by one.
20 new anti-thrombotic products have been approved, the domestic leading class 1 new drug is coming
Figure 1: Sales of antithrombotic drugs in 2020
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
According to data from Menet.
com, affected by the epidemic in the first quarter of 2020, the terminal antithrombotic drug market in public hospitals in key provinces and cities has plummeted by more than 20%.
As the epidemic slows, the sales decline has narrowed since the second quarter, and the annual decline is 9%.
Around, the total sales exceeded 6.
5 billion yuan.
After experiencing the impact of the country's centralized procurement and the epidemic, the overall market declined for the first time last year.
This year, many new products have been launched one after another.
Can it stimulate market vitality again?
com, affected by the epidemic in the first quarter of 2020, the terminal antithrombotic drug market in public hospitals in key provinces and cities has plummeted by more than 20%.
As the epidemic slows, the sales decline has narrowed since the second quarter, and the annual decline is 9%.
Around, the total sales exceeded 6.
5 billion yuan.
After experiencing the impact of the country's centralized procurement and the epidemic, the overall market declined for the first time last year.
This year, many new products have been launched one after another.
Can it stimulate market vitality again?
Table 1: Antithrombotic drugs approved for marketing since 2021 (statistics based on the date of approval)
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Since 2021, a total of 20 new antithrombotic drugs (according to product name + company statistics) have been approved for marketing.
Except for Nanjing Xingyin Pharmaceutical Group's bivalrudine for injection, which has been approved for 6 types of imitations, the remaining 19 products are considered the same After review, Zhaoke Pharmaceutical (Hefei) is the first company to review Fondaparinux Sodium Injection.
Except for Nanjing Xingyin Pharmaceutical Group's bivalrudine for injection, which has been approved for 6 types of imitations, the remaining 19 products are considered the same After review, Zhaoke Pharmaceutical (Hefei) is the first company to review Fondaparinux Sodium Injection.
Figure 2: The status of new class 1 antithrombotic drugs approved for clinical use in 2021
Source: CDE official website
In terms of Class 1 new drugs, Xinlitai announced on March 31, 2021 that the company's SAL0104 capsule was approved for clinical use.
The product is a factor XIa inhibitor, and its intended development indication is the prevention and treatment of thrombotic diseases.
This is the first Class 1 new drug approved for clinical use in this field so far this year, and it is also one of Xinlitai's key research and development products.
The product is a factor XIa inhibitor, and its intended development indication is the prevention and treatment of thrombotic diseases.
This is the first Class 1 new drug approved for clinical use in this field so far this year, and it is also one of Xinlitai's key research and development products.
Xinlitai, the domestic leader in antithrombotic drugs, was ranked behind Sanofi in public hospitals in key provinces and cities in 2013-2017, occupying the TOP2 position.
Since 2018, the country started to pharmnet.
com.
cn/news/yyzb/" target="_blank">purchase in quantity .
Antithrombotic drugs frequently appear in the catalog as commonly used clinical drugs.
After the market has been reshuffled, the ranking of enterprises has also changed.
In 2020, Xinlitai is only ranked in the TOP5.
Generic drugs can hardly escape the situation of centralized procurement and price reduction.
Innovative drugs are the future of the company.
Xinlitai is currently in the stage of continuous transformation from a generic drug company to an innovative drug company.
SAL0104 capsules are the company's new breakthrough in the field of antithrombotic drugs.
.
Since 2018, the country started to pharmnet.
com.
cn/news/yyzb/" target="_blank">purchase in quantity .
Antithrombotic drugs frequently appear in the catalog as commonly used clinical drugs.
After the market has been reshuffled, the ranking of enterprises has also changed.
In 2020, Xinlitai is only ranked in the TOP5.
Generic drugs can hardly escape the situation of centralized procurement and price reduction.
Innovative drugs are the future of the company.
Xinlitai is currently in the stage of continuous transformation from a generic drug company to an innovative drug company.
SAL0104 capsules are the company's new breakthrough in the field of antithrombotic drugs.
.
The fate of nationally sourced varieties is very different, the former TOP1 products plummeted by more than 60%
Table 2: Sales growth rate of antithrombotic drugs included in the national procurement in the past three years
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
Among the TOP10 products of terminal antithrombotic drugs in public hospitals in key provinces and cities from 2015 to 2018, clopidogrel bisulfate tablets firmly held the top spot with sales of over 2 billion yuan, and was included in the first batch (4+7, alliance expansion).
(Wei) After the national mining, sales fell precipitously for two consecutive years.
In 2019, it fell to 1.
7 billion yuan but still ranked first.
In 2020, only 660 million yuan is left, which was won by rivaroxaban with a sales of 960 million yuan.
Championship throne.
(Wei) After the national mining, sales fell precipitously for two consecutive years.
In 2019, it fell to 1.
7 billion yuan but still ranked first.
In 2020, only 660 million yuan is left, which was won by rivaroxaban with a sales of 960 million yuan.
Championship throne.
Figure 3: Competitive landscape of clopidogrel bisulfate tablets enterprises
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
Clopidogrel bisulfate tablets can be regarded as an old variety of antithrombotic drugs.
The original research product entered the Chinese market in 2001, but as early as 2000, the domestic pharmaceutical company Xin Litai obtained the second-class new drug certificate and production approval.
The patent of the original research drug expired in 2012.
Prior to this, the market had been divided by Sanofi and Xinlitai.
It is not easy for the subsequent approved generic drugs to grab the market.
In 2018, the first batch of national sourcing companies took a fancy to this heavy variety.
In order to maintain their market position, Xinlitai and Sanofi joined the price reduction war one after another: in the first batch (4+7) of national sourcing, Xinlitai Exclusively won the bid, a decrease of 58%; during the alliance expansion stage, Sanofi's price was 20% lower than the winning bid of Xinlitai 4+7, showing full sincerity.
Guocai helps the market reshuffle.
Lepu’s market share in 2020 will be more than 10%, while CSPC will also occupy 7%, Sanofi will remain at half of the country, and Xinlitai will remain at around 30%.
The original research product entered the Chinese market in 2001, but as early as 2000, the domestic pharmaceutical company Xin Litai obtained the second-class new drug certificate and production approval.
The patent of the original research drug expired in 2012.
Prior to this, the market had been divided by Sanofi and Xinlitai.
It is not easy for the subsequent approved generic drugs to grab the market.
In 2018, the first batch of national sourcing companies took a fancy to this heavy variety.
In order to maintain their market position, Xinlitai and Sanofi joined the price reduction war one after another: in the first batch (4+7) of national sourcing, Xinlitai Exclusively won the bid, a decrease of 58%; during the alliance expansion stage, Sanofi's price was 20% lower than the winning bid of Xinlitai 4+7, showing full sincerity.
Guocai helps the market reshuffle.
Lepu’s market share in 2020 will be more than 10%, while CSPC will also occupy 7%, Sanofi will remain at half of the country, and Xinlitai will remain at around 30%.
At present, there are 10 companies that have reviewed clopidogrel bisulfate tablets (including deemed review), and 4 domestic pharmaceutical companies such as Dongyang Pharmaceutical and Yangzijiang have declared 4 types of imitations and are under review.
As follow-up products are successively approved After approval and review, more and more companies will have the opportunity to participate in the renewal bidding, and the price may continue to fall.
As follow-up products are successively approved After approval and review, more and more companies will have the opportunity to participate in the renewal bidding, and the price may continue to fall.
Figure 4: The competitive landscape of Apixaban tablets in 2020
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
Apixaban tablets were approved to enter the domestic market in 2013 and entered the National Medical Insurance Catalogue since 2017.
The growth rate of terminal sales in public hospitals in key provinces and cities exceeded 50% from 2017 to 2018.
In 2019, Hausen won the first imitation, and then Chia Tai Tianqing Pharmaceutical Group and Kelun were successively approved in the same year.
Up to now, 11 domestic pharmaceutical companies have been approved and reviewed.
After the listing of domestic generic drugs, the overall sales of the product have been greatly improved.
The sales growth rate of Hausen in 2020 will exceed 621%, and the Chia Tai Tianqing Pharmaceutical Group will reach 1406%.
At present, apixaban tablets are in the high-speed and high-volume stage.
The third batch of national procurement will be implemented in the fourth quarter of 2020.
With the rapid production of products from the winning bidders (Qilu, Hausen, Zhengda Tianqing Pharmaceutical Group, Jiangsu Jiayi Pharmaceutical ) Entering the hospital, the overall sales scale of the product is expected to rise again in 2021, while the market share of the original research drug may decline again.
The growth rate of terminal sales in public hospitals in key provinces and cities exceeded 50% from 2017 to 2018.
In 2019, Hausen won the first imitation, and then Chia Tai Tianqing Pharmaceutical Group and Kelun were successively approved in the same year.
Up to now, 11 domestic pharmaceutical companies have been approved and reviewed.
After the listing of domestic generic drugs, the overall sales of the product have been greatly improved.
The sales growth rate of Hausen in 2020 will exceed 621%, and the Chia Tai Tianqing Pharmaceutical Group will reach 1406%.
At present, apixaban tablets are in the high-speed and high-volume stage.
The third batch of national procurement will be implemented in the fourth quarter of 2020.
With the rapid production of products from the winning bidders (Qilu, Hausen, Zhengda Tianqing Pharmaceutical Group, Jiangsu Jiayi Pharmaceutical ) Entering the hospital, the overall sales scale of the product is expected to rise again in 2021, while the market share of the original research drug may decline again.
Table 3: Products that have been reviewed but not purchased by the country
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Fifth country adopted in full swing, the current has passed assessment of antithrombotic drugs a total of 12 products, which has passed assessment of rivaroxaban tablets enterprises reached 14, in addition, dabigatran etexilate capsules, tirofiban hydrochloride Ban Sodium Chloride Injection has also formed a pattern of "original research + 3 imitation".
Will these three varieties be favored by the national mining company? We will wait and see.
Will these three varieties be favored by the national mining company? We will wait and see.
12 over 100 million varieties, 7 of which are controlled by multinational pharmaceutical companies
Table 4: Antithrombotic drugs with sales exceeding 100 million yuan in 2020
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
In the public hospitals of key provinces and cities , among the large varieties of antithrombotic drugs with sales of over 100 million in 2019, the sales of Ureklin and Tirofiban fell by 28.
19% and 9.
38% respectively in 2020, and both fell out of 2020.
The 100 million yuan list.
19% and 9.
38% respectively in 2020, and both fell out of 2020.
The 100 million yuan list.
From the perspective of market leadership, 7 of the 12 varieties with more than 100 million yuan have been "kings" by multinational pharmaceutical companies, including rivaroxaban, ticagrelor, dabigatran etexilate, aspirin (acetylsalicylic acid), The market share of Alteplase original research drug companies is as high as 90%, and domestic high-end generic drugs must work harder to replace the original research.
Ticagrelor has been included in the national procurement, 6 domestic pharmaceutical companies won the bid, AstraZeneca’s share decline is a high probability event; rivaroxaban and dabigatran etexilate are expected to enter the next batch of catalogues, if included, Bayer and What kind of floor price will Boehringer Ingelheim offer to maintain its market position?
Table 5: Consistency evaluation of aspirin currently under review
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Aspirin is a traditional drug among anti-platelet aggregation drugs.
Due to the low price of the original research drug and the category of medical insurance, the cost-effective advantage of domestic generic drugs is not obvious, resulting in the dominant situation of the original research drug company.
Currently, no domestic pharmaceutical companies have applied for the generic listing of Category 3 and Category 4, but the consistency evaluation of aspirin enteric-coated tablets of Guilin Pharmaceutical and Chenxin Pharmaceutical is under review and approval, and there is still market space for over-evaluated products to replace the original drug.
Due to the low price of the original research drug and the category of medical insurance, the cost-effective advantage of domestic generic drugs is not obvious, resulting in the dominant situation of the original research drug company.
Currently, no domestic pharmaceutical companies have applied for the generic listing of Category 3 and Category 4, but the consistency evaluation of aspirin enteric-coated tablets of Guilin Pharmaceutical and Chenxin Pharmaceutical is under review and approval, and there is still market space for over-evaluated products to replace the original drug.
Alteplase is a recombinant tissue-type plasminogen activator, which can prevent thrombosis and enlargement.
It is the most commonly used thrombolytic agent for the treatment of acute myocardial infarction, cerebral infarction and pulmonary embolism.
At present, only Boehringer Ingelheim is produced and sold in the domestic market.
No domestic pharmaceutical companies have applied for imitation and listing.
The original drug entered the 2009 version of the National Medical Insurance Catalog.
Thrombolysis is limited to within 12 hours of acute myocardial infarction and within 3 hours of cerebral infarction.
For treatment, the price was reduced during the 2020 medical insurance negotiations, but the payment price was not disclosed to the public.
It is the most commonly used thrombolytic agent for the treatment of acute myocardial infarction, cerebral infarction and pulmonary embolism.
At present, only Boehringer Ingelheim is produced and sold in the domestic market.
No domestic pharmaceutical companies have applied for imitation and listing.
The original drug entered the 2009 version of the National Medical Insurance Catalog.
Thrombolysis is limited to within 12 hours of acute myocardial infarction and within 3 hours of cerebral infarction.
For treatment, the price was reduced during the 2020 medical insurance negotiations, but the payment price was not disclosed to the public.
Conclusion
Cardiovascular and cerebrovascular diseases caused by thrombosis are a common disease that seriously threatens humans, especially among middle-aged and elderly people over 50.
With the accelerating aging of our country, the proportion of the affected population in the society is also increasing.
.
On the one hand, with the help of Guocai, domestic high-end generic drugs will have the opportunity to start a head-to-head confrontation with the original research drug.
On the other hand, the research and development results of domestic new drugs are gradually being introduced to the market.
With the continuous efforts of domestic pharmaceutical companies , The era when the antithrombotic drug market is dominated by multinational pharmaceutical companies will eventually come to an end.
With the accelerating aging of our country, the proportion of the affected population in the society is also increasing.
.
On the one hand, with the help of Guocai, domestic high-end generic drugs will have the opportunity to start a head-to-head confrontation with the original research drug.
On the other hand, the research and development results of domestic new drugs are gradually being introduced to the market.
With the continuous efforts of domestic pharmaceutical companies , The era when the antithrombotic drug market is dominated by multinational pharmaceutical companies will eventually come to an end.
Source: Minet database, CDE official website, company announcement
The review data statistics are as of April 13, if there are any errors or omissions, please correct me.
According to data from Meinenet.
com on April 14, Yuandong Bio's dabigatran etexilate capsules and Qianjin Pharmaceutical's apixaban tablets have entered the "under approval" status, and the antithrombotic drug market is expected to add new competition.
By.
The fifth batch of national procurement is like an arrow.
Four antithrombotic drugs have been included in the previous four batches and five rounds.
Among them, the sales of apixaban tablets have soared for three consecutive years.
What are the next batch of nationally-produced hot products? Earlier, the leading domestic pharmaceutical company Xin Litai's anti-thrombotic Class 1 new drug was approved for clinical use.
What is so outstanding about this innovative drug? Next, we analyze one by one.
com on April 14, Yuandong Bio's dabigatran etexilate capsules and Qianjin Pharmaceutical's apixaban tablets have entered the "under approval" status, and the antithrombotic drug market is expected to add new competition.
By.
The fifth batch of national procurement is like an arrow.
Four antithrombotic drugs have been included in the previous four batches and five rounds.
Among them, the sales of apixaban tablets have soared for three consecutive years.
What are the next batch of nationally-produced hot products? Earlier, the leading domestic pharmaceutical company Xin Litai's anti-thrombotic Class 1 new drug was approved for clinical use.
What is so outstanding about this innovative drug? Next, we analyze one by one.
20 new anti-thrombotic products have been approved, the domestic leading class 1 new drug is coming
20 new anti-thrombotic products have been approved, the domestic leading class 1 new drug is coming Figure 1: Sales of antithrombotic drugs in 2020
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
According to data from Menet.
com, affected by the epidemic in the first quarter of 2020, the terminal antithrombotic drug market in public hospitals in key provinces and cities has plummeted by more than 20%.
As the epidemic slows, the sales decline has narrowed since the second quarter, and the annual decline is 9%.
Around, the total sales exceeded 6.
5 billion yuan.
After experiencing the impact of the country's centralized procurement and the epidemic, the overall market declined for the first time last year.
This year, many new products have been launched one after another.
Can it stimulate market vitality again?
com, affected by the epidemic in the first quarter of 2020, the terminal antithrombotic drug market in public hospitals in key provinces and cities has plummeted by more than 20%.
As the epidemic slows, the sales decline has narrowed since the second quarter, and the annual decline is 9%.
Around, the total sales exceeded 6.
5 billion yuan.
After experiencing the impact of the country's centralized procurement and the epidemic, the overall market declined for the first time last year.
This year, many new products have been launched one after another.
Can it stimulate market vitality again?
Table 1: Antithrombotic drugs approved for marketing since 2021 (statistics based on the date of approval)
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Since 2021, a total of 20 new antithrombotic drugs (according to product name + company statistics) have been approved for marketing.
Except for Nanjing Xingyin Pharmaceutical Group's bivalrudine for injection, which has been approved for 6 types of imitations, the remaining 19 products are considered the same After review, Zhaoke Pharmaceutical (Hefei) is the first company to review Fondaparinux Sodium Injection.
Except for Nanjing Xingyin Pharmaceutical Group's bivalrudine for injection, which has been approved for 6 types of imitations, the remaining 19 products are considered the same After review, Zhaoke Pharmaceutical (Hefei) is the first company to review Fondaparinux Sodium Injection.
Figure 2: The status of new class 1 antithrombotic drugs approved for clinical use in 2021
Source: CDE official website
In terms of Class 1 new drugs, Xinlitai announced on March 31, 2021 that the company's SAL0104 capsule was approved for clinical use.
The product is a factor XIa inhibitor, and its intended development indication is the prevention and treatment of thrombotic diseases.
This is the first Class 1 new drug approved for clinical use in this field so far this year, and it is also one of Xinlitai's key research and development products.
The product is a factor XIa inhibitor, and its intended development indication is the prevention and treatment of thrombotic diseases.
This is the first Class 1 new drug approved for clinical use in this field so far this year, and it is also one of Xinlitai's key research and development products.
Xinlitai, the domestic leader in antithrombotic drugs, was ranked behind Sanofi in public hospitals in key provinces and cities in 2013-2017, occupying the TOP2 position.
Since 2018, the country started to pharmnet.
com.
cn/news/yyzb/" target="_blank">purchase in quantity .
Antithrombotic drugs frequently appear in the catalog as commonly used clinical drugs.
After the market has been reshuffled, the ranking of enterprises has also changed.
In 2020, Xinlitai is only ranked in the TOP5.
Generic drugs can hardly escape the situation of centralized procurement and price reduction.
Innovative drugs are the future of the company.
Xinlitai is currently in the stage of continuous transformation from a generic drug company to an innovative drug company.
SAL0104 capsules are the company's new breakthrough in the field of antithrombotic drugs.
.
pharmnet. Since 2018, the country started to pharmnet.
com.
cn/news/yyzb/" target="_blank">purchase in quantity .
Antithrombotic drugs frequently appear in the catalog as commonly used clinical drugs.
After the market has been reshuffled, the ranking of enterprises has also changed.
In 2020, Xinlitai is only ranked in the TOP5.
Generic drugs can hardly escape the situation of centralized procurement and price reduction.
Innovative drugs are the future of the company.
Xinlitai is currently in the stage of continuous transformation from a generic drug company to an innovative drug company.
SAL0104 capsules are the company's new breakthrough in the field of antithrombotic drugs.
.
com.
cn/news/yyzb/" target="_blank">Procurementpharmnet.
com.
cn/news/yyzb/" target="_blank"> Procurement Procurement
The fate of nationally sourced varieties is very different, the former TOP1 products plummeted by more than 60%
The fate of nationally sourced varieties is very different, the former TOP1 products plummeted by more than 60% Table 2: Sales growth rate of antithrombotic drugs included in the national procurement in the past three years
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
Among the TOP10 products of terminal antithrombotic drugs in public hospitals in key provinces and cities from 2015 to 2018, clopidogrel bisulfate tablets firmly held the top spot with sales of over 2 billion yuan, and was included in the first batch (4+7, alliance expansion).
(Wei) After the national mining, sales fell precipitously for two consecutive years.
In 2019, it fell to 1.
7 billion yuan but still ranked first.
In 2020, only 660 million yuan is left, which was won by rivaroxaban with a sales of 960 million yuan.
Championship throne.
(Wei) After the national mining, sales fell precipitously for two consecutive years.
In 2019, it fell to 1.
7 billion yuan but still ranked first.
In 2020, only 660 million yuan is left, which was won by rivaroxaban with a sales of 960 million yuan.
Championship throne.
Figure 3: Competitive landscape of clopidogrel bisulfate tablets enterprises
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
Clopidogrel bisulfate tablets can be regarded as an old variety of antithrombotic drugs.
The original research product entered the Chinese market in 2001, but as early as 2000, the domestic pharmaceutical company Xin Litai obtained the second-class new drug certificate and production approval.
The patent of the original research drug expired in 2012.
Prior to this, the market had been divided by Sanofi and Xinlitai.
It is not easy for the subsequent approved generic drugs to grab the market.
In 2018, the first batch of national sourcing companies took a fancy to this heavy variety.
In order to maintain their market position, Xinlitai and Sanofi joined the price reduction war one after another: in the first batch (4+7) of national sourcing, Xinlitai Exclusively won the bid, a decrease of 58%; during the alliance expansion stage, Sanofi's price was 20% lower than the winning bid of Xinlitai 4+7, showing full sincerity.
Guocai helps the market reshuffle.
Lepu’s market share in 2020 will be more than 10%, while CSPC will also occupy 7%, Sanofi will remain at half of the country, and Xinlitai will remain at around 30%.
The original research product entered the Chinese market in 2001, but as early as 2000, the domestic pharmaceutical company Xin Litai obtained the second-class new drug certificate and production approval.
The patent of the original research drug expired in 2012.
Prior to this, the market had been divided by Sanofi and Xinlitai.
It is not easy for the subsequent approved generic drugs to grab the market.
In 2018, the first batch of national sourcing companies took a fancy to this heavy variety.
In order to maintain their market position, Xinlitai and Sanofi joined the price reduction war one after another: in the first batch (4+7) of national sourcing, Xinlitai Exclusively won the bid, a decrease of 58%; during the alliance expansion stage, Sanofi's price was 20% lower than the winning bid of Xinlitai 4+7, showing full sincerity.
Guocai helps the market reshuffle.
Lepu’s market share in 2020 will be more than 10%, while CSPC will also occupy 7%, Sanofi will remain at half of the country, and Xinlitai will remain at around 30%.
At present, there are 10 companies that have reviewed clopidogrel bisulfate tablets (including deemed review), and 4 domestic pharmaceutical companies such as Dongyang Pharmaceutical and Yangzijiang have declared 4 types of imitations and are under review.
As follow-up products are successively approved After approval and review, more and more companies will have the opportunity to participate in the renewal bidding, and the price may continue to fall.
As follow-up products are successively approved After approval and review, more and more companies will have the opportunity to participate in the renewal bidding, and the price may continue to fall.
Figure 4: The competitive landscape of Apixaban tablets in 2020
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
Apixaban tablets were approved to enter the domestic market in 2013 and entered the National Medical Insurance Catalogue since 2017.
The growth rate of terminal sales in public hospitals in key provinces and cities exceeded 50% from 2017 to 2018.
In 2019, Hausen won the first imitation, and then Chia Tai Tianqing Pharmaceutical Group and Kelun were successively approved in the same year.
Up to now, 11 domestic pharmaceutical companies have been approved and reviewed.
After the listing of domestic generic drugs, the overall sales of the product have been greatly improved.
The sales growth rate of Hausen in 2020 will exceed 621%, and the Chia Tai Tianqing Pharmaceutical Group will reach 1406%.
At present, apixaban tablets are in the high-speed and high-volume stage.
The third batch of national procurement will be implemented in the fourth quarter of 2020.
With the rapid production of products from the winning bidders (Qilu, Hausen, Zhengda Tianqing Pharmaceutical Group, Jiangsu Jiayi Pharmaceutical ) Entering the hospital, the overall sales scale of the product is expected to rise again in 2021, while the market share of the original research drug may decline again.
Medicine Medicine MedicineThe growth rate of terminal sales in public hospitals in key provinces and cities exceeded 50% from 2017 to 2018.
In 2019, Hausen won the first imitation, and then Chia Tai Tianqing Pharmaceutical Group and Kelun were successively approved in the same year.
Up to now, 11 domestic pharmaceutical companies have been approved and reviewed.
After the listing of domestic generic drugs, the overall sales of the product have been greatly improved.
The sales growth rate of Hausen in 2020 will exceed 621%, and the Chia Tai Tianqing Pharmaceutical Group will reach 1406%.
At present, apixaban tablets are in the high-speed and high-volume stage.
The third batch of national procurement will be implemented in the fourth quarter of 2020.
With the rapid production of products from the winning bidders (Qilu, Hausen, Zhengda Tianqing Pharmaceutical Group, Jiangsu Jiayi Pharmaceutical ) Entering the hospital, the overall sales scale of the product is expected to rise again in 2021, while the market share of the original research drug may decline again.
Table 3: Products that have been reviewed but not purchased by the country
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Fifth country adopted in full swing, the current has passed assessment of antithrombotic drugs a total of 12 products, which has passed assessment of rivaroxaban tablets enterprises reached 14, in addition, dabigatran etexilate capsules, tirofiban hydrochloride Ban Sodium Chloride Injection has also formed a pattern of "original research + 3 imitation".
Will these three varieties be favored by the national mining company? We will wait and see.
Enterprise business enterpriseWill these three varieties be favored by the national mining company? We will wait and see.
12 over 100 million varieties, 7 of which are controlled by multinational pharmaceutical companies
12 over 100 million varieties, 7 of which are controlled by multinational pharmaceutical companies Table 4: Antithrombotic drugs with sales exceeding 100 million yuan in 2020
Source: The terminal competition pattern of public hospitals in key provinces and cities of Meinenet
In the public hospitals of key provinces and cities , among the large varieties of antithrombotic drugs with sales of over 100 million in 2019, the sales of Ureklin and Tirofiban fell by 28.
19% and 9.
38% respectively in 2020, and both fell out of 2020.
The 100 million yuan list.
Hospital hospital hospital19% and 9.
38% respectively in 2020, and both fell out of 2020.
The 100 million yuan list.
From the perspective of market leadership, 7 of the 12 varieties with more than 100 million yuan have been "kings" by multinational pharmaceutical companies, including rivaroxaban, ticagrelor, dabigatran etexilate, aspirin (acetylsalicylic acid), The market share of Alteplase original research drug companies is as high as 90%, and domestic high-end generic drugs must work harder to replace the original research.
Ticagrelor has been included in the national procurement, 6 domestic pharmaceutical companies won the bid, AstraZeneca’s share decline is a high probability event; rivaroxaban and dabigatran etexilate are expected to enter the next batch of catalogues, if included, Bayer and What kind of floor price will Boehringer Ingelheim offer to maintain its market position?
Table 5: Consistency evaluation of aspirin currently under review
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Aspirin is a traditional drug among anti-platelet aggregation drugs.
Due to the low price of the original research drug and the category of medical insurance, the cost-effective advantage of domestic generic drugs is not obvious, resulting in the dominant situation of the original research drug company.
Currently, no domestic pharmaceutical companies have applied for the generic listing of Category 3 and Category 4, but the consistency evaluation of aspirin enteric-coated tablets of Guilin Pharmaceutical and Chenxin Pharmaceutical is under review and approval, and there is still market space for over-evaluated products to replace the original drug.
Due to the low price of the original research drug and the category of medical insurance, the cost-effective advantage of domestic generic drugs is not obvious, resulting in the dominant situation of the original research drug company.
Currently, no domestic pharmaceutical companies have applied for the generic listing of Category 3 and Category 4, but the consistency evaluation of aspirin enteric-coated tablets of Guilin Pharmaceutical and Chenxin Pharmaceutical is under review and approval, and there is still market space for over-evaluated products to replace the original drug.
Alteplase is a recombinant tissue-type plasminogen activator, which can prevent thrombosis and enlargement.
It is the most commonly used thrombolytic agent for the treatment of acute myocardial infarction, cerebral infarction and pulmonary embolism.
At present, only Boehringer Ingelheim is produced and sold in the domestic market.
No domestic pharmaceutical companies have applied for imitation and listing.
The original drug entered the 2009 version of the National Medical Insurance Catalog.
Thrombolysis is limited to within 12 hours of acute myocardial infarction and within 3 hours of cerebral infarction.
For treatment, the price was reduced during the 2020 medical insurance negotiations, but the payment price was not disclosed to the public.
It is the most commonly used thrombolytic agent for the treatment of acute myocardial infarction, cerebral infarction and pulmonary embolism.
At present, only Boehringer Ingelheim is produced and sold in the domestic market.
No domestic pharmaceutical companies have applied for imitation and listing.
The original drug entered the 2009 version of the National Medical Insurance Catalog.
Thrombolysis is limited to within 12 hours of acute myocardial infarction and within 3 hours of cerebral infarction.
For treatment, the price was reduced during the 2020 medical insurance negotiations, but the payment price was not disclosed to the public.
Conclusion
Conclusion Cardiovascular and cerebrovascular diseases caused by thrombosis are a common disease that seriously threatens humans, especially among middle-aged and elderly people over 50.
With the accelerating aging of our country, the proportion of the affected population in the society is also increasing.
.
On the one hand, with the help of Guocai, domestic high-end generic drugs will have the opportunity to start a head-to-head confrontation with the original research drug.
On the other hand, the research and development results of domestic new drugs are gradually being introduced to the market.
With the continuous efforts of domestic pharmaceutical companies , The era when the antithrombotic drug market is dominated by multinational pharmaceutical companies will eventually come to an end.
Disease disease diseaseWith the accelerating aging of our country, the proportion of the affected population in the society is also increasing.
.
On the one hand, with the help of Guocai, domestic high-end generic drugs will have the opportunity to start a head-to-head confrontation with the original research drug.
On the other hand, the research and development results of domestic new drugs are gradually being introduced to the market.
With the continuous efforts of domestic pharmaceutical companies , The era when the antithrombotic drug market is dominated by multinational pharmaceutical companies will eventually come to an end.
Source: Minet database, CDE official website, company announcement
Source: Minet database, CDE official website, company announcement The review data statistics are as of April 13, if there are any errors or omissions, please correct me.
