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825 ，，、
。，202160，、、、、122
。，100，、、16
。
。，202160，、、、、122
。，100，、、16
。
60，、、.
.
.
.
.
.
.
.
.
.
.
，2021（，），60（，），12，、
。
。
602040，、、、、、2；，、、、、、、122
。
。
，，/、/、、，202011、17、14、24（824）
。
。
2021
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
From the perspective of domestic sales, the sales of 11 varieties in China's urban public hospitals , county-level public hospitals, urban community centers, township health centers (referred to as China public medical institutions) and Chinese urban retail pharmacies will exceed 100 million in 2020.
Among them, succinate beauty Tolol sustained-release tablets exceed 3 billion yuan, mycophenolate sodium enteric-coated tablets, amlodipine atorvastatin calcium tablets each exceed 800 million yuan, and are expected to exceed the 1 billion mark next year
.
Among them, succinate beauty Tolol sustained-release tablets exceed 3 billion yuan, mycophenolate sodium enteric-coated tablets, amlodipine atorvastatin calcium tablets each exceed 800 million yuan, and are expected to exceed the 1 billion mark next year
.
Since 2021, it has been approved for the first domestic enterprises with 2 or more imitations
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Since 2021, Qilu has won 17 generic drugs (all of which are reported for production under the new classification), which is far ahead of other companies.
Three of them are the first to be imitated, namely rasagiline mesylate tablets and vildagliptin metformin tablets.
And trifluridine tepipyrimidine tablets
.
Three of them are the first to be imitated, namely rasagiline mesylate tablets and vildagliptin metformin tablets.
And trifluridine tepipyrimidine tablets
.
Hengrui, known as "the first brother of innovative drugs", has also made arrangements for high-end generic drugs and first generic drugs.
Since the beginning of this year, 10 generic drugs have been approved (all of which are reported for production under the new classification), of which 3 are the first The imitations are Azilsartan Tablets, Mycophenolate Sodium Enteric-coated Tablets and Dexmedetomidine Hydrochloride Sodium Chloride Injection.
Among them, Mycophenolate Sodium Enteric-coated Tablets will be sold in China in 2020 (Chinese public medical institutions and The total terminal sales of physical pharmacies in cities in China (the same below) is close to 900 million yuan
.
Since the beginning of this year, 10 generic drugs have been approved (all of which are reported for production under the new classification), of which 3 are the first The imitations are Azilsartan Tablets, Mycophenolate Sodium Enteric-coated Tablets and Dexmedetomidine Hydrochloride Sodium Chloride Injection.
Among them, Mycophenolate Sodium Enteric-coated Tablets will be sold in China in 2020 (Chinese public medical institutions and The total terminal sales of physical pharmacies in cities in China (the same below) is close to 900 million yuan
.
With the title of "King of First Imitation", Chia Tai Tianqing Pharmaceutical won 6 first imitations last year, ahead of other companies
.
Since the beginning of this year, 7 generic drugs have been approved (all reported for production under the new classification), of which 2 are the first imitations, namely Futhiaxetine Hydrobromide Tablets and Lenvatinib Mesylate Capsules
.
Although the number of first imitations approved by the company is not the most, the global sales of the two products in 2020 will both exceed $1 billion
.
.
Since the beginning of this year, 7 generic drugs have been approved (all reported for production under the new classification), of which 2 are the first imitations, namely Futhiaxetine Hydrobromide Tablets and Lenvatinib Mesylate Capsules
.
Although the number of first imitations approved by the company is not the most, the global sales of the two products in 2020 will both exceed $1 billion
.
Both Kelun and CSPC have approved more than 10 generic drugs this year, of which 2 are the first generic drugs
.
As a leading infusion company, Kelun’s first imitations are focused on nutritional injections; among the 2 first imitations approved by CSPC, nintedanib ethanesulfonate soft capsules will have global sales of approximately US$2.
4 billion in 2020
.
.
As a leading infusion company, Kelun’s first imitations are focused on nutritional injections; among the 2 first imitations approved by CSPC, nintedanib ethanesulfonate soft capsules will have global sales of approximately US$2.
4 billion in 2020
.
16 blockbuster first imitations on the road, Kelun, Zhengda Tianqing, Hausen.
.
.
.
.
On August 20th, the CDE official website showed that a number of the first imitation products were reported by companies under the new classification, including Regorafenil tablets (Nanjing Zhengda Tianqing), and Trixagliptin succinate tablets (Shiyao Ouyi Pharmaceutical Co.
, Ltd.
) , pyrazolyl talampanel sheet (Hong edge medicine) or the like
.
According to data from Mi Nei.
com, since 2021, about 100 companies with first imitation products have submitted listing applications under the new classification
.
, Ltd.
) , pyrazolyl talampanel sheet (Hong edge medicine) or the like
.
According to data from Mi Nei.
com, since 2021, about 100 companies with first imitation products have submitted listing applications under the new classification
.
Some of the first generic drugs that have been reported by companies since 2021
Note: with * is the first report
Source: Mi Nei Net Database
The competition among the three varieties of Shugeng Sodium Gluconate Injection, Aposterol Tablets, and Sacubatril and Valsartan Sodium Tablets is fierce
.
.
Sugammadex is the world's first selective relaxation antagonist for reversing neuromuscular blockers developed by Merck.
The global sales in 2020 reached 1.
198 billion U.
S.
dollars.
It was approved for import in May 2017, and its domestic sales scale in 2020 Over 170 million yuan, there are currently 18 domestic companies submitting applications for the listing of the product under the new classification, of which Kelun is the first
.
The global sales in 2020 reached 1.
198 billion U.
S.
dollars.
It was approved for import in May 2017, and its domestic sales scale in 2020 Over 170 million yuan, there are currently 18 domestic companies submitting applications for the listing of the product under the new classification, of which Kelun is the first
.
Apster is a PDE-4 inhibitor developed by Sunbase (which has been acquired by Amgen).
In 2020, its global sales reached 2.
195 billion U.
S.
dollars, and it was approved for import in August 2021
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, among which CSPC Ouyi is the first, but Qilu's products are the first to enter the administrative examination and approval stage
.
In 2020, its global sales reached 2.
195 billion U.
S.
dollars, and it was approved for import in August 2021
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, among which CSPC Ouyi is the first, but Qilu's products are the first to enter the administrative examination and approval stage
.
Sacubitril and Valsartan is an angiotensin receptor/enkephalinase inhibitor developed by Novartis.
It is a new anti-heart failure drug.
The global sales in 2020 reached 2.
497 billion U.
S.
dollars.
It was approved for import in August 2017.
In 2019, it was negotiated to be included in the National Medical Insurance Category B.
In 2020, the domestic sales scale will exceed 800 million yuan
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, of which Xuantai Haimen is the first
.
It is a new anti-heart failure drug.
The global sales in 2020 reached 2.
497 billion U.
S.
dollars.
It was approved for import in August 2017.
In 2019, it was negotiated to be included in the National Medical Insurance Category B.
In 2020, the domestic sales scale will exceed 800 million yuan
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, of which Xuantai Haimen is the first
.
Five varieties of osimertinib mesylate tablets, mabaloxavir tablets, ibrutinib capsules, selepagram tablets, and idoxaban tosylate tablets are exclusively reported for production
.
.
Osimertinib is a third-generation EGFR-TKI developed by AstraZeneca.
In 2020, its global sales reached 4.
328 billion U.
S.
dollars.
It was approved for import in March 2017.
In the same year, it was included in the national medical insurance category B through negotiations.
The domestic sales scale will be in 2020.
Over 4.
5 billion yuan, Jiangsu Wanbang Biochemical submitted a listing application with imitation 4 types on May 12, 2021
.
In 2020, its global sales reached 4.
328 billion U.
S.
dollars.
It was approved for import in March 2017.
In the same year, it was included in the national medical insurance category B through negotiations.
The domestic sales scale will be in 2020.
Over 4.
5 billion yuan, Jiangsu Wanbang Biochemical submitted a listing application with imitation 4 types on May 12, 2021
.
Mabaloxavir is an anti-influenza single-dose oral drug with a new mechanism of action jointly developed by Shiono Yoshio/Roche, and is the third batch of clinically urgently needed overseas new drugs
.
The original researched product was approved for import in April 2021, and CSPC Ouyi Pharmaceutical submitted a marketing application for imitation type 4 on July 1, 2021
.
.
The original researched product was approved for import in April 2021, and CSPC Ouyi Pharmaceutical submitted a marketing application for imitation type 4 on July 1, 2021
.
Ibrutinib is the world's first BTK inhibitor developed by Johnson & Johnson/AbbVie.
In 2020, its global sales reached 9.
442 billion U.
S.
dollars.
It was approved for import in August 2017.
In the same year, it was included in the National Medical Insurance Category B through negotiations and will be available in China in 2020.
With a sales scale of more than 1.
1 billion yuan, Simcere Pharmaceuticals submitted its application for listing in 4 generic categories on April 7, 2021
.
In 2020, its global sales reached 9.
442 billion U.
S.
dollars.
It was approved for import in August 2017.
In the same year, it was included in the National Medical Insurance Category B through negotiations and will be available in China in 2020.
With a sales scale of more than 1.
1 billion yuan, Simcere Pharmaceuticals submitted its application for listing in 4 generic categories on April 7, 2021
.
Sleppug is an IP receptor agonist developed by Johnson & Johnson's Actylon.
It is a new drug for pulmonary hypertension.
In 2020, its global sales reached 1.
093 billion U.
S.
dollars.
It was approved for import in December 2018 and included in the national medical insurance through negotiations in 2019.
Category B, the domestic sales scale in 2020 will exceed 30 million yuan.
On June 25, 2021, Hausen submitted a listing application for the imitation of Category 4
.
It is a new drug for pulmonary hypertension.
In 2020, its global sales reached 1.
093 billion U.
S.
dollars.
It was approved for import in December 2018 and included in the national medical insurance through negotiations in 2019.
Category B, the domestic sales scale in 2020 will exceed 30 million yuan.
On June 25, 2021, Hausen submitted a listing application for the imitation of Category 4
.
Adoxaban is a new oral anticoagulant drug developed by Daiichi Sankyo, with global sales of 154.
1 billion yen in 2020.
It was approved for import in January 2019.
In 2020, it will be included in the national medical insurance category B through negotiations.
On June 2, 2021, the pharmaceutical industry submitted a marketing application for generic 4 categories
.
1 billion yen in 2020.
It was approved for import in January 2019.
In 2020, it will be included in the national medical insurance category B through negotiations.
On June 2, 2021, the pharmaceutical industry submitted a marketing application for generic 4 categories
.
Policy and market blessings, the domestic first generic drug competition is becoming increasingly fierce
The first generic drug has always been one of the priorities of the domestic pharmaceutical companies’ R&D layout.
With the comprehensive advancement of the drug review reform, as well as policies such as consistency evaluation and volume procurement , domestic pharmaceutical companies are increasingly competing for the first generic drug.
A wave of drug approvals has emerged
.
With the comprehensive advancement of the drug review reform, as well as policies such as consistency evaluation and volume procurement , domestic pharmaceutical companies are increasingly competing for the first generic drug.
A wave of drug approvals has emerged
.
Compared with innovative drugs, the development difficulty and cost of the first generic drugs are lower.
With the implementation of the consistency evaluation policy, the efficacy of their products can also be verified, which is one of the choices for generic drug companies to "explore and expand"
.
With the implementation of the consistency evaluation policy, the efficacy of their products can also be verified, which is one of the choices for generic drug companies to "explore and expand"
.
In addition, the first generic drug is an extension of corporate strategy and deep cultivation of the field, such as Hengrui, Qilu, and Hausen, which focus on the field of anti-tumor, Zhengda Tianqing, which focuses on the field of liver disease, and Xinli in the field of anticoagulation.
Tai et al.
These companies use innovative drugs and the first generic drugs to fight a combination of punches, and coordinate their efforts to deepen their advantageous fields
.
Tai et al.
These companies use innovative drugs and the first generic drugs to fight a combination of punches, and coordinate their efforts to deepen their advantageous fields
.
At the same time, in recent years, the domestic drug reform policy has also given vigorous advancement in "encouraging the first generic drugs"
.
.
The first is the reform of the review and approval system
.
The first generic drugs are easier to be included in the priority review and approval procedures, shortening their time to market, so that they can open the market faster
.
.
The first generic drugs are easier to be included in the priority review and approval procedures, shortening their time to market, so that they can open the market faster
.
The second is the period of market exclusivity
.
In July 2021, the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" was officially released.
The first generic drug that succeeds in the patent challenge will receive a one-year market exclusivity period
.
Prior to this, there have been many successful patent challenges and the first imitating cases that have been approved for listing, such as tofacitib from Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
, and ticagrelor from Xinlitai
.
.
In July 2021, the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" was officially released.
The first generic drug that succeeds in the patent challenge will receive a one-year market exclusivity period
.
Prior to this, there have been many successful patent challenges and the first imitating cases that have been approved for listing, such as tofacitib from Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
, and ticagrelor from Xinlitai
.
With the ever-faster review and approval speed, the superposition of the "patent link system" and the introduction of the "first imitation exclusive period", and the deepening of domestic pharmaceutical companies' awareness of drug patents, the competition for first generic drugs will intensify in the future
.
.
Source: Mi Nei Net Database
Note: China's urban entity pharmacy terminal competition pattern database is an enlarged version of the urban entity pharmacy database that covers 293 prefectures and cities across the country (excluding county and rural entity pharmacies), and continuously monitors all categories
.
The above sales are calculated based on the average retail price of the product at the terminal
.
Statistics are as of August 23.
If there are any omissions, please correct me!
.
The above sales are calculated based on the average retail price of the product at the terminal
.
Statistics are as of August 23.
If there are any omissions, please correct me!
Pharmaceutical Net, August 25.
Recently, a number of first generic drugs have been approved for listing, including Huilun Jiangsu Pharmaceutical's Serodosin Capsules and Chia Tai Tianqing's Futhiaxetine Hydrobromide Tablets
.
According to data from Mi Nei.
com, since 2021, more than 60 first generic drugs have been approved for listing, and 12 companies including Hengrui, Qilu, Renfu, Haisco, and Kelun have been approved with 2 or more first generic drugs
.
In addition, about 100 first imitation varieties have been reported by companies under the new classification, including 16 blockbuster star drugs such as Ibrutinib, Aprost and Osimertinib
.
Recently, a number of first generic drugs have been approved for listing, including Huilun Jiangsu Pharmaceutical's Serodosin Capsules and Chia Tai Tianqing's Futhiaxetine Hydrobromide Tablets
.
According to data from Mi Nei.
com, since 2021, more than 60 first generic drugs have been approved for listing, and 12 companies including Hengrui, Qilu, Renfu, Haisco, and Kelun have been approved with 2 or more first generic drugs
.
In addition, about 100 first imitation varieties have been reported by companies under the new classification, including 16 blockbuster star drugs such as Ibrutinib, Aprost and Osimertinib
.
More than 60 first copy approvals this year , Qilu, Hengrui, Renfu.
.
.
are eye-catching
.
.
are eye-catching
According to data from Mi Nei.
com, from 2021 to the present (counted by the start date of the state, the same below), more than 60 domestic first generic drugs (including the first imitation of the dosage form, the same below) have been approved for marketing, covering 12 major therapeutic categories, focusing on nerves Systemic drugs, anti-tumor and immunomodulators, and cardiovascular system drugs
.
com, from 2021 to the present (counted by the start date of the state, the same below), more than 60 domestic first generic drugs (including the first imitation of the dosage form, the same below) have been approved for marketing, covering 12 major therapeutic categories, focusing on nerves Systemic drugs, anti-tumor and immunomodulators, and cardiovascular system drugs
.
More than 60 first generic drugs involved more than 20 approved import companies and more than 40 domestic companies.
Multinational companies such as Novartis, Boehringer Ingelheim, Servier, Daiichi Sankyo, Bayer, Pfizer and other multinational companies involved 2 types.
Among the domestic pharmaceutical companies, 12 companies including Hengrui, Qilu, Haisco, Osaikang, Kelun, Renfu, and Chia Tai Tianqing have been approved for the first copy number of 2 or more
.
Multinational companies such as Novartis, Boehringer Ingelheim, Servier, Daiichi Sankyo, Bayer, Pfizer and other multinational companies involved 2 types.
Among the domestic pharmaceutical companies, 12 companies including Hengrui, Qilu, Haisco, Osaikang, Kelun, Renfu, and Chia Tai Tianqing have been approved for the first copy number of 2 or more
.
From the perspective of the global sales of original products, there are many heavy varieties, such as Lingbei/Takeda’s vothiaxetine, Eisai/Mersha Dong’s lenvatinib, Astellas’ Mirabellon, and Boehringer Ingelheim’s Nintedanib, etc.
, global sales in 2020 will exceed 1.
1 billion U.
S.
dollars, 1.
7 billion U.
S.
dollars, 1.
4 billion U.
S.
dollars, and 2.
4 billion U.
S.
dollars (exchange rates are calculated on August 24)
.
, global sales in 2020 will exceed 1.
1 billion U.
S.
dollars, 1.
7 billion U.
S.
dollars, 1.
4 billion U.
S.
dollars, and 2.
4 billion U.
S.
dollars (exchange rates are calculated on August 24)
.
Some of the first imitations approved since 2021
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
From the perspective of domestic sales, the sales of 11 varieties in China's urban public hospitals , county-level public hospitals, urban community centers, township health centers (referred to as China public medical institutions) and Chinese urban retail pharmacies will exceed 100 million in 2020.
Among them, succinate beauty Tolol sustained-release tablets exceed 3 billion yuan, mycophenolate sodium enteric-coated tablets, amlodipine atorvastatin calcium tablets each exceed 800 million yuan, and are expected to exceed the 1 billion mark next year
.
Among them, succinate beauty Tolol sustained-release tablets exceed 3 billion yuan, mycophenolate sodium enteric-coated tablets, amlodipine atorvastatin calcium tablets each exceed 800 million yuan, and are expected to exceed the 1 billion mark next year
.
Since 2021, it has been approved for the first domestic enterprises with 2 or more imitations
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Since 2021, Qilu has won 17 generic drugs (all of which are reported for production under the new classification), which is far ahead of other companies.
Three of them are the first to be imitated, namely rasagiline mesylate tablets and vildagliptin metformin tablets.
And trifluridine tepipyrimidine tablets
.
Three of them are the first to be imitated, namely rasagiline mesylate tablets and vildagliptin metformin tablets.
And trifluridine tepipyrimidine tablets
.
Hengrui, known as "the first brother of innovative drugs", has also made arrangements for high-end generic drugs and first generic drugs.
Since the beginning of this year, 10 generic drugs have been approved (all of which are reported for production under the new classification), of which 3 are the first The imitations are Azilsartan Tablets, Mycophenolate Sodium Enteric-coated Tablets and Dexmedetomidine Hydrochloride Sodium Chloride Injection.
Among them, Mycophenolate Sodium Enteric-coated Tablets will be sold in China in 2020 (Chinese public medical institutions and The total terminal sales of physical pharmacies in cities in China (the same below) is close to 900 million yuan
.
Since the beginning of this year, 10 generic drugs have been approved (all of which are reported for production under the new classification), of which 3 are the first The imitations are Azilsartan Tablets, Mycophenolate Sodium Enteric-coated Tablets and Dexmedetomidine Hydrochloride Sodium Chloride Injection.
Among them, Mycophenolate Sodium Enteric-coated Tablets will be sold in China in 2020 (Chinese public medical institutions and The total terminal sales of physical pharmacies in cities in China (the same below) is close to 900 million yuan
.
With the title of "King of First Imitation", Chia Tai Tianqing Pharmaceutical won 6 first imitations last year, ahead of other companies
.
Since the beginning of this year, 7 generic drugs have been approved (all reported for production under the new classification), of which 2 are the first imitations, namely Futhiaxetine Hydrobromide Tablets and Lenvatinib Mesylate Capsules
.
Although the number of first imitations approved by the company is not the most, the global sales of the two products in 2020 will both exceed $1 billion
.
.
Since the beginning of this year, 7 generic drugs have been approved (all reported for production under the new classification), of which 2 are the first imitations, namely Futhiaxetine Hydrobromide Tablets and Lenvatinib Mesylate Capsules
.
Although the number of first imitations approved by the company is not the most, the global sales of the two products in 2020 will both exceed $1 billion
.
Both Kelun and CSPC have approved more than 10 generic drugs this year, of which 2 are the first generic drugs
.
As a leading infusion company, Kelun’s first imitations are focused on nutritional injections; among the 2 first imitations approved by CSPC, nintedanib ethanesulfonate soft capsules will have global sales of approximately US$2.
4 billion in 2020
.
.
As a leading infusion company, Kelun’s first imitations are focused on nutritional injections; among the 2 first imitations approved by CSPC, nintedanib ethanesulfonate soft capsules will have global sales of approximately US$2.
4 billion in 2020
.
16 blockbuster first imitations on the road, Kelun, Zhengda Tianqing, Hausen.
.
.
.
.
On August 20th, the CDE official website showed that a number of the first imitation products were reported by companies under the new classification, including Regorafenil tablets (Nanjing Zhengda Tianqing), and Trixagliptin succinate tablets (Shiyao Ouyi Pharmaceutical Co.
, Ltd.
) , pyrazolyl talampanel sheet (Hong edge medicine) or the like
.
According to data from Mi Nei.
com, since 2021, about 100 companies with first imitation products have submitted listing applications under the new classification
.
, Ltd.
) , pyrazolyl talampanel sheet (Hong edge medicine) or the like
.
According to data from Mi Nei.
com, since 2021, about 100 companies with first imitation products have submitted listing applications under the new classification
.
Some of the first generic drugs that have been reported by companies since 2021
Note: with * is the first report
Source: Mi Nei Net Database
The competition among the three varieties of Shugeng Sodium Gluconate Injection, Aposterol Tablets, and Sacubatril and Valsartan Sodium Tablets is fierce
.
.
Sugammadex is the world's first selective relaxation antagonist for reversing neuromuscular blockers developed by Merck.
The global sales in 2020 reached 1.
198 billion U.
S.
dollars.
It was approved for import in May 2017, and its domestic sales scale in 2020 Over 170 million yuan, there are currently 18 domestic companies submitting applications for the listing of the product under the new classification, of which Kelun is the first
.
The global sales in 2020 reached 1.
198 billion U.
S.
dollars.
It was approved for import in May 2017, and its domestic sales scale in 2020 Over 170 million yuan, there are currently 18 domestic companies submitting applications for the listing of the product under the new classification, of which Kelun is the first
.
Apster is a PDE-4 inhibitor developed by Sunbase (which has been acquired by Amgen).
In 2020, its global sales reached 2.
195 billion U.
S.
dollars, and it was approved for import in August 2021
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, among which CSPC Ouyi is the first, but Qilu's products are the first to enter the administrative examination and approval stage
.
In 2020, its global sales reached 2.
195 billion U.
S.
dollars, and it was approved for import in August 2021
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, among which CSPC Ouyi is the first, but Qilu's products are the first to enter the administrative examination and approval stage
.
Sacubitril and Valsartan is an angiotensin receptor/enkephalinase inhibitor developed by Novartis.
It is a new anti-heart failure drug.
The global sales in 2020 reached 2.
497 billion U.
S.
dollars.
It was approved for import in August 2017.
In 2019, it was negotiated to be included in the National Medical Insurance Category B.
In 2020, the domestic sales scale will exceed 800 million yuan
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, of which Xuantai Haimen is the first
.
It is a new anti-heart failure drug.
The global sales in 2020 reached 2.
497 billion U.
S.
dollars.
It was approved for import in August 2017.
In 2019, it was negotiated to be included in the National Medical Insurance Category B.
In 2020, the domestic sales scale will exceed 800 million yuan
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, of which Xuantai Haimen is the first
.
Five varieties of osimertinib mesylate tablets, mabaloxavir tablets, ibrutinib capsules, selepagram tablets, and idoxaban tosylate tablets are exclusively reported for production
.
.
Osimertinib is a third-generation EGFR-TKI developed by AstraZeneca.
In 2020, its global sales reached 4.
328 billion U.
S.
dollars.
It was approved for import in March 2017.
In the same year, it was included in the national medical insurance category B through negotiations.
The domestic sales scale will be in 2020.
Over 4.
5 billion yuan, Jiangsu Wanbang Biochemical submitted a listing application with imitation 4 types on May 12, 2021
.
In 2020, its global sales reached 4.
328 billion U.
S.
dollars.
It was approved for import in March 2017.
In the same year, it was included in the national medical insurance category B through negotiations.
The domestic sales scale will be in 2020.
Over 4.
5 billion yuan, Jiangsu Wanbang Biochemical submitted a listing application with imitation 4 types on May 12, 2021
.
Mabaloxavir is an anti-influenza single-dose oral drug with a new mechanism of action jointly developed by Shiono Yoshio/Roche, and is the third batch of clinically urgently needed overseas new drugs
.
The original researched product was approved for import in April 2021, and CSPC Ouyi Pharmaceutical submitted a marketing application for imitation type 4 on July 1, 2021
.
.
The original researched product was approved for import in April 2021, and CSPC Ouyi Pharmaceutical submitted a marketing application for imitation type 4 on July 1, 2021
.
Ibrutinib is the world's first BTK inhibitor developed by Johnson & Johnson/AbbVie.
In 2020, its global sales reached 9.
442 billion U.
S.
dollars.
It was approved for import in August 2017.
In the same year, it was included in the National Medical Insurance Category B through negotiations and will be available in China in 2020.
With a sales scale of more than 1.
1 billion yuan, Simcere Pharmaceuticals submitted its application for listing in 4 generic categories on April 7, 2021
.
In 2020, its global sales reached 9.
442 billion U.
S.
dollars.
It was approved for import in August 2017.
In the same year, it was included in the National Medical Insurance Category B through negotiations and will be available in China in 2020.
With a sales scale of more than 1.
1 billion yuan, Simcere Pharmaceuticals submitted its application for listing in 4 generic categories on April 7, 2021
.
Sleppug is an IP receptor agonist developed by Johnson & Johnson's Actylon.
It is a new drug for pulmonary hypertension.
In 2020, its global sales reached 1.
093 billion U.
S.
dollars.
It was approved for import in December 2018 and included in the national medical insurance through negotiations in 2019.
Category B, the domestic sales scale in 2020 will exceed 30 million yuan.
On June 25, 2021, Hausen submitted a listing application for the imitation of Category 4
.
It is a new drug for pulmonary hypertension.
In 2020, its global sales reached 1.
093 billion U.
S.
dollars.
It was approved for import in December 2018 and included in the national medical insurance through negotiations in 2019.
Category B, the domestic sales scale in 2020 will exceed 30 million yuan.
On June 25, 2021, Hausen submitted a listing application for the imitation of Category 4
.
Adoxaban is a new oral anticoagulant drug developed by Daiichi Sankyo, with global sales of 154.
1 billion yen in 2020.
It was approved for import in January 2019.
In 2020, it will be included in the national medical insurance category B through negotiations.
On June 2, 2021, the pharmaceutical industry submitted a marketing application for generic 4 categories
.
1 billion yen in 2020.
It was approved for import in January 2019.
In 2020, it will be included in the national medical insurance category B through negotiations.
On June 2, 2021, the pharmaceutical industry submitted a marketing application for generic 4 categories
.
Policy and market blessings, the domestic first generic drug competition is becoming increasingly fierce
The first generic drug has always been one of the priorities of the domestic pharmaceutical companies’ R&D layout.
With the comprehensive advancement of the drug review reform, as well as policies such as consistency evaluation and volume procurement , domestic pharmaceutical companies are increasingly competing for the first generic drug.
A wave of drug approvals has emerged
.
With the comprehensive advancement of the drug review reform, as well as policies such as consistency evaluation and volume procurement , domestic pharmaceutical companies are increasingly competing for the first generic drug.
A wave of drug approvals has emerged
.
Compared with innovative drugs, the development difficulty and cost of the first generic drugs are lower.
With the implementation of the consistency evaluation policy, the efficacy of their products can also be verified, which is one of the choices for generic drug companies to "explore and expand"
.
With the implementation of the consistency evaluation policy, the efficacy of their products can also be verified, which is one of the choices for generic drug companies to "explore and expand"
.
In addition, the first generic drug is an extension of corporate strategy and deep cultivation of the field, such as Hengrui, Qilu, and Hausen, which focus on the field of anti-tumor, Zhengda Tianqing, which focuses on the field of liver disease, and Xinli in the field of anticoagulation.
Tai et al.
These companies use innovative drugs and the first generic drugs to fight a combination of punches, and coordinate their efforts to deepen their advantageous fields
.
Tai et al.
These companies use innovative drugs and the first generic drugs to fight a combination of punches, and coordinate their efforts to deepen their advantageous fields
.
At the same time, in recent years, the domestic drug reform policy has also given vigorous advancement in "encouraging the first generic drugs"
.
.
The first is the reform of the review and approval system
.
The first generic drugs are easier to be included in the priority review and approval procedures, shortening their time to market, so that they can open the market faster
.
.
The first generic drugs are easier to be included in the priority review and approval procedures, shortening their time to market, so that they can open the market faster
.
The second is the period of market exclusivity
.
In July 2021, the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" was officially released.
The first generic drug that succeeds in the patent challenge will receive a one-year market exclusivity period
.
Prior to this, there have been many successful patent challenges and the first imitating cases that have been approved for listing, such as tofacitib from Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
, and ticagrelor from Xinlitai
.
.
In July 2021, the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" was officially released.
The first generic drug that succeeds in the patent challenge will receive a one-year market exclusivity period
.
Prior to this, there have been many successful patent challenges and the first imitating cases that have been approved for listing, such as tofacitib from Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
, and ticagrelor from Xinlitai
.
With the ever-faster review and approval speed, the superposition of the "patent link system" and the introduction of the "first imitation exclusive period", and the deepening of domestic pharmaceutical companies' awareness of drug patents, the competition for first generic drugs will intensify in the future
.
.
Source: Mi Nei Net Database
Note: China's urban entity pharmacy terminal competition pattern database is an enlarged version of the urban entity pharmacy database that covers 293 prefectures and cities across the country (excluding county and rural entity pharmacies), and continuously monitors all categories
.
The above sales are calculated based on the average retail price of the product at the terminal
.
Statistics are as of August 23.
If there are any omissions, please correct me!
.
The above sales are calculated based on the average retail price of the product at the terminal
.
Statistics are as of August 23.
If there are any omissions, please correct me!
Pharmaceutical Net, August 25.
Recently, a number of first generic drugs have been approved for listing, including Huilun Jiangsu Pharmaceutical's Serodosin Capsules and Chia Tai Tianqing's Futhiaxetine Hydrobromide Tablets
.
According to data from Mi Nei.
com, since 2021, more than 60 first generic drugs have been approved for listing, and 12 companies including Hengrui, Qilu, Renfu, Haisco, and Kelun have been approved with 2 or more first generic drugs
.
In addition, about 100 first imitation varieties have been reported by companies under the new classification, including 16 blockbuster star drugs such as Ibrutinib, Aprost and Osimertinib
.
Recently, a number of first generic drugs have been approved for listing, including Huilun Jiangsu Pharmaceutical's Serodosin Capsules and Chia Tai Tianqing's Futhiaxetine Hydrobromide Tablets
.
According to data from Mi Nei.
com, since 2021, more than 60 first generic drugs have been approved for listing, and 12 companies including Hengrui, Qilu, Renfu, Haisco, and Kelun have been approved with 2 or more first generic drugs
.
In addition, about 100 first imitation varieties have been reported by companies under the new classification, including 16 blockbuster star drugs such as Ibrutinib, Aprost and Osimertinib
.
More than 60 first copy approvals this year , Qilu, Hengrui, Renfu.
.
.
are eye-catching
.
.
are eye-catching
According to data from Mi Nei.
com, from 2021 to the present (counted by the start date of the state, the same below), more than 60 domestic first generic drugs (including the first imitation of the dosage form, the same below) have been approved for marketing, covering 12 major therapeutic categories, focusing on nerves Systemic drugs, anti-tumor and immunomodulators, and cardiovascular system drugs
.
com, from 2021 to the present (counted by the start date of the state, the same below), more than 60 domestic first generic drugs (including the first imitation of the dosage form, the same below) have been approved for marketing, covering 12 major therapeutic categories, focusing on nerves Systemic drugs, anti-tumor and immunomodulators, and cardiovascular system drugs
.
More than 60 first generic drugs involved more than 20 approved import companies and more than 40 domestic companies.
Multinational companies such as Novartis, Boehringer Ingelheim, Servier, Daiichi Sankyo, Bayer, Pfizer and other multinational companies involved 2 types.
Among the domestic pharmaceutical companies, 12 companies including Hengrui, Qilu, Haisco, Osaikang, Kelun, Renfu, and Chia Tai Tianqing have been approved for the first copy number of 2 or more
.
Multinational companies such as Novartis, Boehringer Ingelheim, Servier, Daiichi Sankyo, Bayer, Pfizer and other multinational companies involved 2 types.
Among the domestic pharmaceutical companies, 12 companies including Hengrui, Qilu, Haisco, Osaikang, Kelun, Renfu, and Chia Tai Tianqing have been approved for the first copy number of 2 or more
.
From the perspective of the global sales of original products, there are many heavy varieties, such as Lingbei/Takeda’s vothiaxetine, Eisai/Mersha Dong’s lenvatinib, Astellas’ Mirabellon, and Boehringer Ingelheim’s Nintedanib, etc.
, global sales in 2020 will exceed 1.
1 billion U.
S.
dollars, 1.
7 billion U.
S.
dollars, 1.
4 billion U.
S.
dollars, and 2.
4 billion U.
S.
dollars (exchange rates are calculated on August 24)
.
, global sales in 2020 will exceed 1.
1 billion U.
S.
dollars, 1.
7 billion U.
S.
dollars, 1.
4 billion U.
S.
dollars, and 2.
4 billion U.
S.
dollars (exchange rates are calculated on August 24)
.
Some of the first imitations approved since 2021
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
From the perspective of domestic sales, the sales of 11 varieties in China's urban public hospitals , county-level public hospitals, urban community centers, township health centers (referred to as China public medical institutions) and Chinese urban retail pharmacies will exceed 100 million in 2020.
Among them, succinate beauty Tolol sustained-release tablets exceed 3 billion yuan, mycophenolate sodium enteric-coated tablets, amlodipine atorvastatin calcium tablets each exceed 800 million yuan, and are expected to exceed the 1 billion mark next year
.
Among them, succinate beauty Tolol sustained-release tablets exceed 3 billion yuan, mycophenolate sodium enteric-coated tablets, amlodipine atorvastatin calcium tablets each exceed 800 million yuan, and are expected to exceed the 1 billion mark next year
.
Since 2021, it has been approved for the first domestic enterprises with 2 or more imitations
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Since 2021, Qilu has won 17 generic drugs (all of which are reported for production under the new classification), which is far ahead of other companies.
Three of them are the first to be imitated, namely rasagiline mesylate tablets and vildagliptin metformin tablets.
And trifluridine tepipyrimidine tablets
.
Three of them are the first to be imitated, namely rasagiline mesylate tablets and vildagliptin metformin tablets.
And trifluridine tepipyrimidine tablets
.
Hengrui, known as "the first brother of innovative drugs", has also made arrangements for high-end generic drugs and first generic drugs.
Since the beginning of this year, 10 generic drugs have been approved (all of which are reported for production under the new classification), of which 3 are the first The imitations are Azilsartan Tablets, Mycophenolate Sodium Enteric-coated Tablets and Dexmedetomidine Hydrochloride Sodium Chloride Injection.
Among them, Mycophenolate Sodium Enteric-coated Tablets will be sold in China in 2020 (Chinese public medical institutions and The total terminal sales of physical pharmacies in cities in China (the same below) is close to 900 million yuan
.
Since the beginning of this year, 10 generic drugs have been approved (all of which are reported for production under the new classification), of which 3 are the first The imitations are Azilsartan Tablets, Mycophenolate Sodium Enteric-coated Tablets and Dexmedetomidine Hydrochloride Sodium Chloride Injection.
Among them, Mycophenolate Sodium Enteric-coated Tablets will be sold in China in 2020 (Chinese public medical institutions and The total terminal sales of physical pharmacies in cities in China (the same below) is close to 900 million yuan
.
With the title of "King of First Imitation", Chia Tai Tianqing Pharmaceutical won 6 first imitations last year, ahead of other companies
.
Since the beginning of this year, 7 generic drugs have been approved (all reported for production under the new classification), of which 2 are the first imitations, namely Futhiaxetine Hydrobromide Tablets and Lenvatinib Mesylate Capsules
.
Although the number of first imitations approved by the company is not the most, the global sales of the two products in 2020 will both exceed $1 billion
.
.
Since the beginning of this year, 7 generic drugs have been approved (all reported for production under the new classification), of which 2 are the first imitations, namely Futhiaxetine Hydrobromide Tablets and Lenvatinib Mesylate Capsules
.
Although the number of first imitations approved by the company is not the most, the global sales of the two products in 2020 will both exceed $1 billion
.
Both Kelun and CSPC have approved more than 10 generic drugs this year, of which 2 are the first generic drugs
.
As a leading infusion company, Kelun’s first imitations are focused on nutritional injections; among the 2 first imitations approved by CSPC, nintedanib ethanesulfonate soft capsules will have global sales of approximately US$2.
4 billion in 2020
.
.
As a leading infusion company, Kelun’s first imitations are focused on nutritional injections; among the 2 first imitations approved by CSPC, nintedanib ethanesulfonate soft capsules will have global sales of approximately US$2.
4 billion in 2020
.
16 blockbuster first imitations on the road, Kelun, Zhengda Tianqing, Hausen.
.
.
.
.
On August 20th, the CDE official website showed that a number of the first imitation products were reported by companies under the new classification, including Regorafenil tablets (Nanjing Zhengda Tianqing), and Trixagliptin succinate tablets (Shiyao Ouyi Pharmaceutical Co.
, Ltd.
) , pyrazolyl talampanel sheet (Hong edge medicine) or the like
.
According to data from Mi Nei.
com, since 2021, about 100 companies with first imitation products have submitted listing applications under the new classification
.
, Ltd.
) , pyrazolyl talampanel sheet (Hong edge medicine) or the like
.
According to data from Mi Nei.
com, since 2021, about 100 companies with first imitation products have submitted listing applications under the new classification
.
Some of the first generic drugs that have been reported by companies since 2021
Note: with * is the first report
Source: Mi Nei Net Database
The competition among the three varieties of Shugeng Sodium Gluconate Injection, Aposterol Tablets, and Sacubatril and Valsartan Sodium Tablets is fierce
.
.
Sugammadex is the world's first selective relaxation antagonist for reversing neuromuscular blockers developed by Merck.
The global sales in 2020 reached 1.
198 billion U.
S.
dollars.
It was approved for import in May 2017, and its domestic sales scale in 2020 Over 170 million yuan, there are currently 18 domestic companies submitting applications for the listing of the product under the new classification, of which Kelun is the first
.
The global sales in 2020 reached 1.
198 billion U.
S.
dollars.
It was approved for import in May 2017, and its domestic sales scale in 2020 Over 170 million yuan, there are currently 18 domestic companies submitting applications for the listing of the product under the new classification, of which Kelun is the first
.
Apster is a PDE-4 inhibitor developed by Sunbase (which has been acquired by Amgen).
In 2020, its global sales reached 2.
195 billion U.
S.
dollars, and it was approved for import in August 2021
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, among which CSPC Ouyi is the first, but Qilu's products are the first to enter the administrative examination and approval stage
.
In 2020, its global sales reached 2.
195 billion U.
S.
dollars, and it was approved for import in August 2021
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, among which CSPC Ouyi is the first, but Qilu's products are the first to enter the administrative examination and approval stage
.
Sacubitril and Valsartan is an angiotensin receptor/enkephalinase inhibitor developed by Novartis.
It is a new anti-heart failure drug.
The global sales in 2020 reached 2.
497 billion U.
S.
dollars.
It was approved for import in August 2017.
In 2019, it was negotiated to be included in the National Medical Insurance Category B.
In 2020, the domestic sales scale will exceed 800 million yuan
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, of which Xuantai Haimen is the first
.
It is a new anti-heart failure drug.
The global sales in 2020 reached 2.
497 billion U.
S.
dollars.
It was approved for import in August 2017.
In 2019, it was negotiated to be included in the National Medical Insurance Category B.
In 2020, the domestic sales scale will exceed 800 million yuan
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, of which Xuantai Haimen is the first
.
Five varieties of osimertinib mesylate tablets, mabaloxavir tablets, ibrutinib capsules, selepagram tablets, and idoxaban tosylate tablets are exclusively reported for production
.
.
Osimertinib is a third-generation EGFR-TKI developed by AstraZeneca.
In 2020, its global sales reached 4.
328 billion U.
S.
dollars.
It was approved for import in March 2017.
In the same year, it was included in the national medical insurance category B through negotiations.
The domestic sales scale will be in 2020.
Over 4.
5 billion yuan, Jiangsu Wanbang Biochemical submitted a listing application with imitation 4 types on May 12, 2021
.
In 2020, its global sales reached 4.
328 billion U.
S.
dollars.
It was approved for import in March 2017.
In the same year, it was included in the national medical insurance category B through negotiations.
The domestic sales scale will be in 2020.
Over 4.
5 billion yuan, Jiangsu Wanbang Biochemical submitted a listing application with imitation 4 types on May 12, 2021
.
Mabaloxavir is an anti-influenza single-dose oral drug with a new mechanism of action jointly developed by Shiono Yoshio/Roche, and is the third batch of clinically urgently needed overseas new drugs
.
The original researched product was approved for import in April 2021, and CSPC Ouyi Pharmaceutical submitted a marketing application for imitation type 4 on July 1, 2021
.
.
The original researched product was approved for import in April 2021, and CSPC Ouyi Pharmaceutical submitted a marketing application for imitation type 4 on July 1, 2021
.
Ibrutinib is the world's first BTK inhibitor developed by Johnson & Johnson/AbbVie.
In 2020, its global sales reached 9.
442 billion U.
S.
dollars.
It was approved for import in August 2017.
In the same year, it was included in the National Medical Insurance Category B through negotiations and will be available in China in 2020.
With a sales scale of more than 1.
1 billion yuan, Simcere Pharmaceuticals submitted its application for listing in 4 generic categories on April 7, 2021
.
In 2020, its global sales reached 9.
442 billion U.
S.
dollars.
It was approved for import in August 2017.
In the same year, it was included in the National Medical Insurance Category B through negotiations and will be available in China in 2020.
With a sales scale of more than 1.
1 billion yuan, Simcere Pharmaceuticals submitted its application for listing in 4 generic categories on April 7, 2021
.
Sleppug is an IP receptor agonist developed by Johnson & Johnson's Actylon.
It is a new drug for pulmonary hypertension.
In 2020, its global sales reached 1.
093 billion U.
S.
dollars.
It was approved for import in December 2018 and included in the national medical insurance through negotiations in 2019.
Category B, the domestic sales scale in 2020 will exceed 30 million yuan.
On June 25, 2021, Hausen submitted a listing application for the imitation of Category 4
.
It is a new drug for pulmonary hypertension.
In 2020, its global sales reached 1.
093 billion U.
S.
dollars.
It was approved for import in December 2018 and included in the national medical insurance through negotiations in 2019.
Category B, the domestic sales scale in 2020 will exceed 30 million yuan.
On June 25, 2021, Hausen submitted a listing application for the imitation of Category 4
.
Adoxaban is a new oral anticoagulant drug developed by Daiichi Sankyo, with global sales of 154.
1 billion yen in 2020.
It was approved for import in January 2019.
In 2020, it will be included in the national medical insurance category B through negotiations.
On June 2, 2021, the pharmaceutical industry submitted a marketing application for generic 4 categories
.
1 billion yen in 2020.
It was approved for import in January 2019.
In 2020, it will be included in the national medical insurance category B through negotiations.
On June 2, 2021, the pharmaceutical industry submitted a marketing application for generic 4 categories
.
Policy and market blessings, the domestic first generic drug competition is becoming increasingly fierce
The first generic drug has always been one of the priorities of the domestic pharmaceutical companies’ R&D layout.
With the comprehensive advancement of the drug review reform, as well as policies such as consistency evaluation and volume procurement , domestic pharmaceutical companies are increasingly competing for the first generic drug.
A wave of drug approvals has emerged
.
With the comprehensive advancement of the drug review reform, as well as policies such as consistency evaluation and volume procurement , domestic pharmaceutical companies are increasingly competing for the first generic drug.
A wave of drug approvals has emerged
.
Compared with innovative drugs, the development difficulty and cost of the first generic drugs are lower.
With the implementation of the consistency evaluation policy, the efficacy of their products can also be verified, which is one of the choices for generic drug companies to "explore and expand"
.
With the implementation of the consistency evaluation policy, the efficacy of their products can also be verified, which is one of the choices for generic drug companies to "explore and expand"
.
In addition, the first generic drug is an extension of corporate strategy and deep cultivation of the field, such as Hengrui, Qilu, and Hausen, which focus on the field of anti-tumor, Zhengda Tianqing, which focuses on the field of liver disease, and Xinli in the field of anticoagulation.
Tai et al.
These companies use innovative drugs and the first generic drugs to fight a combination of punches, and coordinate their efforts to deepen their advantageous fields
.
Tai et al.
These companies use innovative drugs and the first generic drugs to fight a combination of punches, and coordinate their efforts to deepen their advantageous fields
.
At the same time, in recent years, the domestic drug reform policy has also given vigorous advancement in "encouraging the first generic drugs"
.
.
The first is the reform of the review and approval system
.
The first generic drugs are easier to be included in the priority review and approval procedures, shortening their time to market, so that they can open the market faster
.
.
The first generic drugs are easier to be included in the priority review and approval procedures, shortening their time to market, so that they can open the market faster
.
The second is the period of market exclusivity
.
In July 2021, the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" was officially released.
The first generic drug that succeeds in the patent challenge will receive a one-year market exclusivity period
.
Prior to this, there have been many successful patent challenges and the first imitating cases that have been approved for listing, such as tofacitib from Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
, and ticagrelor from Xinlitai
.
.
In July 2021, the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" was officially released.
The first generic drug that succeeds in the patent challenge will receive a one-year market exclusivity period
.
Prior to this, there have been many successful patent challenges and the first imitating cases that have been approved for listing, such as tofacitib from Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
, and ticagrelor from Xinlitai
.
With the ever-faster review and approval speed, the superposition of the "patent link system" and the introduction of the "first imitation exclusive period", and the deepening of domestic pharmaceutical companies' awareness of drug patents, the competition for first generic drugs will intensify in the future
.
.
Source: Mi Nei Net Database
Note: China's urban entity pharmacy terminal competition pattern database is an enlarged version of the urban entity pharmacy database that covers 293 prefectures and cities across the country (excluding county and rural entity pharmacies), and continuously monitors all categories
.
The above sales are calculated based on the average retail price of the product at the terminal
.
Statistics are as of August 23.
If there are any omissions, please correct me!
.
The above sales are calculated based on the average retail price of the product at the terminal
.
Statistics are as of August 23.
If there are any omissions, please correct me!
Pharmaceutical Net, August 25.
Recently, a number of first generic drugs have been approved for listing, including Huilun Jiangsu Pharmaceutical's Serodosin Capsules and Chia Tai Tianqing's Futhiaxetine Hydrobromide Tablets
.
According to data from Mi Nei.
com, since 2021, more than 60 first generic drugs have been approved for listing, and 12 companies including Hengrui, Qilu, Renfu, Haisco, and Kelun have been approved with 2 or more first generic drugs
.
In addition, about 100 first imitation varieties have been reported by companies under the new classification, including 16 blockbuster star drugs such as Ibrutinib, Aprost and Osimertinib
.
Recently, a number of first generic drugs have been approved for listing, including Huilun Jiangsu Pharmaceutical's Serodosin Capsules and Chia Tai Tianqing's Futhiaxetine Hydrobromide Tablets
.
According to data from Mi Nei.
com, since 2021, more than 60 first generic drugs have been approved for listing, and 12 companies including Hengrui, Qilu, Renfu, Haisco, and Kelun have been approved with 2 or more first generic drugs
.
In addition, about 100 first imitation varieties have been reported by companies under the new classification, including 16 blockbuster star drugs such as Ibrutinib, Aprost and Osimertinib
.
More than 60 first copy approvals this year , Qilu, Hengrui, Renfu.
.
.
are eye-catching
More than 60 first copy approvals this year , Qilu, Hengrui, Renfu. .
.
are eye-catching
.
.
are eye-catching
According to data from Mi Nei.
com, from 2021 to the present (counted by the start date of the state, the same below), more than 60 domestic first generic drugs (including the first imitation of the dosage form, the same below) have been approved for marketing, covering 12 major therapeutic categories, focusing on nerves Systemic drugs, anti-tumor and immunomodulators, and cardiovascular system drugs
.
com, from 2021 to the present (counted by the start date of the state, the same below), more than 60 domestic first generic drugs (including the first imitation of the dosage form, the same below) have been approved for marketing, covering 12 major therapeutic categories, focusing on nerves Systemic drugs, anti-tumor and immunomodulators, and cardiovascular system drugs
.
More than 60 first generic drugs involved more than 20 approved import companies and more than 40 domestic companies.
Multinational companies such as Novartis, Boehringer Ingelheim, Servier, Daiichi Sankyo, Bayer, Pfizer and other multinational companies involved 2 types.
Among the domestic pharmaceutical companies, 12 companies including Hengrui, Qilu, Haisco, Osaikang, Kelun, Renfu, and Chia Tai Tianqing have been approved for the first copy number of 2 or more
.
Enterprise business enterpriseMultinational companies such as Novartis, Boehringer Ingelheim, Servier, Daiichi Sankyo, Bayer, Pfizer and other multinational companies involved 2 types.
Among the domestic pharmaceutical companies, 12 companies including Hengrui, Qilu, Haisco, Osaikang, Kelun, Renfu, and Chia Tai Tianqing have been approved for the first copy number of 2 or more
.
From the perspective of the global sales of original products, there are many heavy varieties, such as Lingbei/Takeda’s vothiaxetine, Eisai/Mersha Dong’s lenvatinib, Astellas’ Mirabellon, and Boehringer Ingelheim’s Nintedanib, etc.
, global sales in 2020 will exceed 1.
1 billion U.
S.
dollars, 1.
7 billion U.
S.
dollars, 1.
4 billion U.
S.
dollars, and 2.
4 billion U.
S.
dollars (exchange rates are calculated on August 24)
.
, global sales in 2020 will exceed 1.
1 billion U.
S.
dollars, 1.
7 billion U.
S.
dollars, 1.
4 billion U.
S.
dollars, and 2.
4 billion U.
S.
dollars (exchange rates are calculated on August 24)
.
Some of the first imitations approved since 2021
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
From the perspective of domestic sales, the sales of 11 varieties in China's urban public hospitals , county-level public hospitals, urban community centers, township health centers (referred to as China public medical institutions) and Chinese urban retail pharmacies will exceed 100 million in 2020.
Among them, succinate beauty Tolol sustained-release tablets exceed 3 billion yuan, mycophenolate sodium enteric-coated tablets, amlodipine atorvastatin calcium tablets each exceed 800 million yuan, and are expected to exceed the 1 billion mark next year
.
Hospital hospital hospital pharmacy pharmacy pharmacyAmong them, succinate beauty Tolol sustained-release tablets exceed 3 billion yuan, mycophenolate sodium enteric-coated tablets, amlodipine atorvastatin calcium tablets each exceed 800 million yuan, and are expected to exceed the 1 billion mark next year
.
Since 2021, it has been approved for the first domestic enterprises with 2 or more imitations
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Since 2021, Qilu has won 17 generic drugs (all of which are reported for production under the new classification), which is far ahead of other companies.
Three of them are the first to be imitated, namely rasagiline mesylate tablets and vildagliptin metformin tablets.
And trifluridine tepipyrimidine tablets
.
Three of them are the first to be imitated, namely rasagiline mesylate tablets and vildagliptin metformin tablets.
And trifluridine tepipyrimidine tablets
.
Hengrui, known as "the first brother of innovative drugs", has also made arrangements for high-end generic drugs and first generic drugs.
Since the beginning of this year, 10 generic drugs have been approved (all of which are reported for production under the new classification), of which 3 are the first The imitations are Azilsartan Tablets, Mycophenolate Sodium Enteric-coated Tablets and Dexmedetomidine Hydrochloride Sodium Chloride Injection.
Among them, Mycophenolate Sodium Enteric-coated Tablets will be sold in China in 2020 (Chinese public medical institutions and The total terminal sales of physical pharmacies in cities in China (the same below) is close to 900 million yuan
.
Since the beginning of this year, 10 generic drugs have been approved (all of which are reported for production under the new classification), of which 3 are the first The imitations are Azilsartan Tablets, Mycophenolate Sodium Enteric-coated Tablets and Dexmedetomidine Hydrochloride Sodium Chloride Injection.
Among them, Mycophenolate Sodium Enteric-coated Tablets will be sold in China in 2020 (Chinese public medical institutions and The total terminal sales of physical pharmacies in cities in China (the same below) is close to 900 million yuan
.
With the title of "King of First Imitation", Chia Tai Tianqing Pharmaceutical won 6 first imitations last year, ahead of other companies
.
Since the beginning of this year, 7 generic drugs have been approved (all reported for production under the new classification), of which 2 are the first imitations, namely Futhiaxetine Hydrobromide Tablets and Lenvatinib Mesylate Capsules
.
Although the number of first imitations approved by the company is not the most, the global sales of the two products in 2020 will both exceed $1 billion
.
.
Since the beginning of this year, 7 generic drugs have been approved (all reported for production under the new classification), of which 2 are the first imitations, namely Futhiaxetine Hydrobromide Tablets and Lenvatinib Mesylate Capsules
.
Although the number of first imitations approved by the company is not the most, the global sales of the two products in 2020 will both exceed $1 billion
.
Both Kelun and CSPC have approved more than 10 generic drugs this year, of which 2 are the first generic drugs
.
As a leading infusion company, Kelun’s first imitations are focused on nutritional injections; among the 2 first imitations approved by CSPC, nintedanib ethanesulfonate soft capsules will have global sales of approximately US$2.
4 billion in 2020
.
.
As a leading infusion company, Kelun’s first imitations are focused on nutritional injections; among the 2 first imitations approved by CSPC, nintedanib ethanesulfonate soft capsules will have global sales of approximately US$2.
4 billion in 2020
.
16 blockbuster first imitations on the road, Kelun, Zhengda Tianqing, Hausen.
.
.
16 blockbuster first imitations on the road, Kelun, Zhengda Tianqing, Hausen. .
.
.
.
On August 20th, the CDE official website showed that a number of the first imitation products were reported by companies under the new classification, including Regorafenil tablets (Nanjing Zhengda Tianqing), and Trixagliptin succinate tablets (Shiyao Ouyi Pharmaceutical Co.
, Ltd.
) , pyrazolyl talampanel sheet (Hong edge medicine) or the like
.
According to data from Mi Nei.
com, since 2021, about 100 companies with first imitation products have submitted listing applications under the new classification
.
, Ltd.
) , pyrazolyl talampanel sheet (Hong edge medicine) or the like
.
According to data from Mi Nei.
com, since 2021, about 100 companies with first imitation products have submitted listing applications under the new classification
.
Some of the first generic drugs that have been reported by companies since 2021
Note: with * is the first report
Source: Mi Nei Net Database
The competition among the three varieties of Shugeng Sodium Gluconate Injection, Aposterol Tablets, and Sacubatril and Valsartan Sodium Tablets is fierce
.
.
Sugammadex is the world's first selective relaxation antagonist for reversing neuromuscular blockers developed by Merck.
The global sales in 2020 reached 1.
198 billion U.
S.
dollars.
It was approved for import in May 2017, and its domestic sales scale in 2020 Over 170 million yuan, there are currently 18 domestic companies submitting applications for the listing of the product under the new classification, of which Kelun is the first
.
The global sales in 2020 reached 1.
198 billion U.
S.
dollars.
It was approved for import in May 2017, and its domestic sales scale in 2020 Over 170 million yuan, there are currently 18 domestic companies submitting applications for the listing of the product under the new classification, of which Kelun is the first
.
Apster is a PDE-4 inhibitor developed by Sunbase (which has been acquired by Amgen).
In 2020, its global sales reached 2.
195 billion U.
S.
dollars, and it was approved for import in August 2021
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, among which CSPC Ouyi is the first, but Qilu's products are the first to enter the administrative examination and approval stage
.
In 2020, its global sales reached 2.
195 billion U.
S.
dollars, and it was approved for import in August 2021
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, among which CSPC Ouyi is the first, but Qilu's products are the first to enter the administrative examination and approval stage
.
Sacubitril and Valsartan is an angiotensin receptor/enkephalinase inhibitor developed by Novartis.
It is a new anti-heart failure drug.
The global sales in 2020 reached 2.
497 billion U.
S.
dollars.
It was approved for import in August 2017.
In 2019, it was negotiated to be included in the National Medical Insurance Category B.
In 2020, the domestic sales scale will exceed 800 million yuan
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, of which Xuantai Haimen is the first
.
It is a new anti-heart failure drug.
The global sales in 2020 reached 2.
497 billion U.
S.
dollars.
It was approved for import in August 2017.
In 2019, it was negotiated to be included in the National Medical Insurance Category B.
In 2020, the domestic sales scale will exceed 800 million yuan
.
At present, 8 domestic companies have submitted applications for the listing of this product under the new classification, of which Xuantai Haimen is the first
.
Five varieties of osimertinib mesylate tablets, mabaloxavir tablets, ibrutinib capsules, selepagram tablets, and idoxaban tosylate tablets are exclusively reported for production
.
.
Osimertinib is a third-generation EGFR-TKI developed by AstraZeneca.
In 2020, its global sales reached 4.
328 billion U.
S.
dollars.
It was approved for import in March 2017.
In the same year, it was included in the national medical insurance category B through negotiations.
The domestic sales scale will be in 2020.
Over 4.
5 billion yuan, Jiangsu Wanbang Biochemical submitted a listing application with imitation 4 types on May 12, 2021
.
In 2020, its global sales reached 4.
328 billion U.
S.
dollars.
It was approved for import in March 2017.
In the same year, it was included in the national medical insurance category B through negotiations.
The domestic sales scale will be in 2020.
Over 4.
5 billion yuan, Jiangsu Wanbang Biochemical submitted a listing application with imitation 4 types on May 12, 2021
.
Mabaloxavir is an anti-influenza single-dose oral drug with a new mechanism of action jointly developed by Shiono Yoshio/Roche, and is the third batch of clinically urgently needed overseas new drugs
.
The original researched product was approved for import in April 2021, and CSPC Ouyi Pharmaceutical submitted a marketing application for imitation type 4 on July 1, 2021
.
.
The original researched product was approved for import in April 2021, and CSPC Ouyi Pharmaceutical submitted a marketing application for imitation type 4 on July 1, 2021
.
Ibrutinib is the world's first BTK inhibitor developed by Johnson & Johnson/AbbVie.
In 2020, its global sales reached 9.
442 billion U.
S.
dollars.
It was approved for import in August 2017.
In the same year, it was included in the National Medical Insurance Category B through negotiations and will be available in China in 2020.
With a sales scale of more than 1.
1 billion yuan, Simcere Pharmaceuticals submitted its application for listing in 4 generic categories on April 7, 2021
.
In 2020, its global sales reached 9.
442 billion U.
S.
dollars.
It was approved for import in August 2017.
In the same year, it was included in the National Medical Insurance Category B through negotiations and will be available in China in 2020.
With a sales scale of more than 1.
1 billion yuan, Simcere Pharmaceuticals submitted its application for listing in 4 generic categories on April 7, 2021
.
Sleppug is an IP receptor agonist developed by Johnson & Johnson's Actylon.
It is a new drug for pulmonary hypertension.
In 2020, its global sales reached 1.
093 billion U.
S.
dollars.
It was approved for import in December 2018 and included in the national medical insurance through negotiations in 2019.
Category B, the domestic sales scale in 2020 will exceed 30 million yuan.
On June 25, 2021, Hausen submitted a listing application for the imitation of Category 4
.
It is a new drug for pulmonary hypertension.
In 2020, its global sales reached 1.
093 billion U.
S.
dollars.
It was approved for import in December 2018 and included in the national medical insurance through negotiations in 2019.
Category B, the domestic sales scale in 2020 will exceed 30 million yuan.
On June 25, 2021, Hausen submitted a listing application for the imitation of Category 4
.
Adoxaban is a new oral anticoagulant drug developed by Daiichi Sankyo, with global sales of 154.
1 billion yen in 2020.
It was approved for import in January 2019.
In 2020, it will be included in the national medical insurance category B through negotiations.
On June 2, 2021, the pharmaceutical industry submitted a marketing application for generic 4 categories
.
1 billion yen in 2020.
It was approved for import in January 2019.
In 2020, it will be included in the national medical insurance category B through negotiations.
On June 2, 2021, the pharmaceutical industry submitted a marketing application for generic 4 categories
.
Policy and market blessings, the domestic first generic drug competition is becoming increasingly fierce
The first generic drug has always been one of the priorities of the domestic pharmaceutical companies’ R&D layout.
With the comprehensive advancement of the drug review reform, as well as policies such as consistency evaluation and volume procurement , domestic pharmaceutical companies are increasingly competing for the first generic drug.
A wave of drug approvals has emerged
.
Procurement Procurement ProcurementWith the comprehensive advancement of the drug review reform, as well as policies such as consistency evaluation and volume procurement , domestic pharmaceutical companies are increasingly competing for the first generic drug.
A wave of drug approvals has emerged
.
Compared with innovative drugs, the development difficulty and cost of the first generic drugs are lower.
With the implementation of the consistency evaluation policy, the efficacy of their products can also be verified, which is one of the choices for generic drug companies to "explore and expand"
.
With the implementation of the consistency evaluation policy, the efficacy of their products can also be verified, which is one of the choices for generic drug companies to "explore and expand"
.
In addition, the first generic drug is an extension of corporate strategy and deep cultivation of the field, such as Hengrui, Qilu, and Hausen, which focus on the field of anti-tumor, Zhengda Tianqing, which focuses on the field of liver disease, and Xinli in the field of anticoagulation.
Tai et al.
These companies use innovative drugs and the first generic drugs to fight a combination of punches, and coordinate their efforts to deepen their advantageous fields
.
Tai et al.
These companies use innovative drugs and the first generic drugs to fight a combination of punches, and coordinate their efforts to deepen their advantageous fields
.
At the same time, in recent years, the domestic drug reform policy has also given vigorous advancement in "encouraging the first generic drugs"
.
.
The first is the reform of the review and approval system
.
The first generic drugs are easier to be included in the priority review and approval procedures, shortening their time to market, so that they can open the market faster
.
.
The first generic drugs are easier to be included in the priority review and approval procedures, shortening their time to market, so that they can open the market faster
.
The second is the period of market exclusivity
.
In July 2021, the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" was officially released.
The first generic drug that succeeds in the patent challenge will receive a one-year market exclusivity period
.
Prior to this, there have been many successful patent challenges and the first imitating cases that have been approved for listing, such as tofacitib from Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
, and ticagrelor from Xinlitai
.
.
In July 2021, the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" was officially released.
The first generic drug that succeeds in the patent challenge will receive a one-year market exclusivity period
.
Prior to this, there have been many successful patent challenges and the first imitating cases that have been approved for listing, such as tofacitib from Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
, and ticagrelor from Xinlitai
.
With the ever-faster review and approval speed, the superposition of the "patent link system" and the introduction of the "first imitation exclusive period", and the deepening of domestic pharmaceutical companies' awareness of drug patents, the competition for first generic drugs will intensify in the future
.
Medicine, medicine, medicine.
Source: Mi Nei Net Database
Source: Mi Nei Net Database Note: China's urban entity pharmacy terminal competition pattern database is an enlarged version of the urban entity pharmacy database that covers 293 prefectures and cities across the country (excluding county and rural entity pharmacies), and continuously monitors all categories
.
The above sales are calculated based on the average retail price of the product at the terminal
.
Statistics are as of August 23.
If there are any omissions, please correct me!
.
The above sales are calculated based on the average retail price of the product at the terminal
.
Statistics are as of August 23.
If there are any omissions, please correct me!
