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Medical Network News, March 22.
Recently, the National Health Commission and other six departments officially announced the "Second Batch of Encouraged Generic Drugs Catalog", and 17 more varieties were included.
Up to now, the two batches of catalogs have included a total of 50 varieties ( According to the common name + dosage form, there are 56 products)
.
It is reported that the included varieties are drugs whose domestic patents are about to expire but have not yet filed for registration, clinical supply shortages or insufficient competition.
Companies imitating related drugs can receive clinical trials, research on key common technologies, and priority review and approval
.
According to data from Mi Nei.
com, domestic generic drug terminal sales in 2019 amounted to more than 1,000 billion yuan.
Affected by the volume procurement and key monitoring catalog policies, the growth rate of generic drugs continues to slow down.
The entry of high-end generic drugs is expected to stimulate new vitality in the market
.
Encourage imitation to produce results! Chia Tai Tianqing took the lead to win the "first domestic"
In June 2019, the "First Batch of Encouraging Generic Drugs Catalog Recommendation List" was released, and the list of catalogs was officially announced in October of the same year.
In the end, Ripavirin tablets were eliminated and 33 varieties were successfully selected.
.
In December 2020, the "Second Batch of Encouraging Generic Drugs Catalog Recommendation List" was released, and the list was officially announced in March 2021.
Brimonidine timolol eye drops and olaparib tablets were eliminated, and finally 17 varieties were successful Selected
.
Table 1: Status of products with domestic approvals in encouraging imitation drugs Source: One-click search on Mynet.
com According to statistics, 14 of the 56 drugs encouraged to imitation have domestic approvals.
Thanks to policy encouragement, Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
The Group, Zhaoke Pharmaceutical, and Shanghai Xuantai Haimen Pharmaceutical received priority review dividends, and their products were quickly approved for listing
.
According to data from Meinenet.
com, the fosapitant dimeglumine for injection of CP Tianqing Pharmaceutical Group declared for the listing of a 3.
1-category new drug in September 2015 and was included in the priority review in September 2017.
The reason was "before patent expiration.
" One-year drug production application" was approved for marketing in October 2019, becoming the first domestic product of this product
.
With the successive approvals of Hausen and Qilu, 3 domestic companies have been approved.
Shandong Luoxin Pharmaceutical Group's 3 types of generic listing applications have been reviewed and approved.
.
In 2020, CP Tianqing Pharmaceutical Group won the first domestic imitation of AstraZeneca's blockbuster injection fulvestrant
.
The global sales of the original research products in 2018 exceeded 1 billion U.
S.
dollars.
In 2019, the total sales in China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) terminals and Chinese urban physical pharmacies terminals More than 500 million yuan
.
Chia Tai Tianqing Pharmaceutical Group declared 4 types of generic listings in January 2019, and was included in the priority review in April 2020.
The reason was "overseas co-line", and it was approved for listing in August of the same year
.
At present, the 4 types of generic listing applications of Hausen and Hangzhou Jiuyuan Genetic Engineering are under review and approval.
Under the impact of domestic high-end generic drugs, AstraZeneca's market share is in jeopardy
.
Merck’s posaconazole sold for US$740 million globally in 2018.
Currently, the domestic dosage forms that have been imported include oral suspension, enteric-coated tablets and injections
.
In the first batch of encouraged imitation catalogs, injections and enteric-coated tablets were included.
Shanghai Xuantai Haimen Pharmaceuticals submitted posaconazole enteric-coated tablets 4 types of imitation listing applications in February 2019, and was included in the priority review in September of the same year.
, The reason is "overseas co-line", won the first domestic imitation in January 2021
.
Sichuan Kelun Pharmaceutical's 4 types of generic posaconazole enteric-coated tablets are under review and approval, and it is expected to become the second domestic company
.
At present, Merck’s enteric-coated tablets have not yet increased their sales in the domestic market, and domestic high-end imitations are expected to take the lead
.
Zhaoke Pharmaceutical’s Quqianlienier injection was declared for the 4 types of generic marketing in December 2018, and was included in the priority review in June 2019.
The reason was “drugs for rare diseases”.
The first imitation was approved in March 2020
.
Treprostinil is a synthetic prostacyclin drug that can promote vasodilation and inhibit platelet aggregation.
It is used for the symptomatic treatment of pulmonary hypertension.
This product has a long half-life, stable drug structure and convenient use.
It is used as a first-line treatment and Rescue drugs are widely used
.
In addition, although dapsone, mercaptopurine, methotrexate, cyclophosphamide and other varieties currently have domestic approvals, no companies have reviewed them.
Companies are encouraged to develop and produce high-end generic drugs, which will help improve the overall quality of the varieties
.
10 first imitations will be launched, Hengrui, Osaikang.
.
.
to sprint
Table 2: There is no domestic approval, but imitation products are under review.
Source: Meinenet MED2.
0 China Drug Evaluation Database Encourages 10 imitation catalogs The product is about to usher in the first domestic imitation, and the monopoly of domestic market by multinational giants such as Merck, Novartis and Sanofi is expected to be broken
.
As mentioned earlier, posaconazole is Merck’s blockbuster variety, and the injection was approved for import in 2021
.
Osaikang applied for posaconazole injection 3 generic listing application in August 2018, and was included in the priority review in February 2019.
The reason is "the drug production application 1 year before the patent expires".
The current acceptance number is in In the review and approval, Oseikon has the greatest probability of winning the first domestic imitation in terms of application time and policy encouragement
.
Qilu and Qingfeng Pharmaceutical Co.
, Ltd.
applied for 3 types of generic listings in September 2020 and January 2021 respectively, and are currently under review and approval; Simcere Pharmaceuticals|Hangzhou Aoya Biotechnology Co.
, Ltd.
declared 4 types of generic listings in February 2021.
It has been accepted
.
Chengdu Shengdi Pharmaceutical, a subsidiary of Hengrui , applied for the generic listing of tafluprost eye drops in January 2020, and was included in the priority review in May of the same year.
The reason was that "medicine in urgent clinical need and shortage in the market"
.
This product is the first preservative-free prostaglandin analog eye drops, which is clinically mainly used to reduce open-angle glaucoma or ocular hypertension in patients with elevated intraocular pressure.
It is now a negotiated product in the National Medical Insurance Catalogue
.
Mirabegron sustained-release tablets were included in the second batch of encouraged imitation catalogs.
The original research drug company Astellas sold 161.
6 billion yen (approximately US$1.
48 billion) globally in 2019, and was approved to enter the domestic market in 2017.
Successfully entered the national medical insurance catalog in the year of negotiation
.
Huadong Pharmaceutical Group Huayi Pharmaceutical Co.
, Ltd.
declared 4 types of generic listings in October 2019, and was included in the priority review in March 2020.
The reason was "the drug production application one year before the patent expires"
.
Currently, Nanjing Chia Tai Tianqing Pharmaceutical and Sichuan Guowei Pharmaceutical Co.
, Ltd.
applied for the 4 types of generic listing acceptance numbers in September 2020 and January 2021, respectively, are under review and approval
.
Eliglustat capsule is Sanofi-Aventis's blockbuster orphan drug, with global sales of 210 million euros (approximately US$250 million) in 2019.
The original research product has not yet been approved for import
.
Concord Pharmaceuticals|Beijing Gloria Tiancheng Pharmaceutical Technology Co.
, Ltd.
declared for the 3 types of generic listings in April 2019, and was subsequently included in the priority review.
The reason was "rare disease drugs".
Currently, no other companies have applied for listing
.
Sanofi, Johnson & Johnson’s blockbuster products were looted, Kelun, Qingfeng.
.
.
are at the forefront.
Table 3: No domestic approvals, no companies have applied for listing but existing companies have been approved for clinical products.
Source: Minet.
com MED2.
0 There are still 32 products in the catalogue of imitations encouraged by the China Drug Evaluation Database.
There are currently no domestic approval documents and no companies have applied for listing.
17 of these products have been approved for clinical use.
Among them, Sanofi’s cabazitaxel and Pfizer’s demethylation Venlafaxine, Dofetilide and Johnson & Johnson's Bosentan are the hottest, with more than 7 domestic pharmaceutical companies approved for clinical trials
.
Cabazitaxel is a new generation of semi-synthetic taxanes.
A number of in vivo and in vitro studies have shown that it has good anti-tumor effects.
Sanofi was approved by the FDA in 2010 and its global sales exceeded 400 million euros in 2018.
Set a new high in 2020, reaching 540 million euros
.
Figure 1: Kelun’s latest clinical progress of cabazitaxel injection Source: Meinenet China Drug Clinical Trial Public Library At present, a total of 11 domestic pharmaceutical companies have declared and approved the clinical application of Cabazitaxel injection for category 3.
1 new drugs, Sichuan The Kelun Pharmaceutical Research Institute received clinical approval in 2015.
The latest progress is that the phase I clinical trial of advanced solid tumors has been completed, and related trials involving gastric cancer or gastroesophageal junction adenocarcinoma are underway
.
Johnson & Johnson's Bosentan is a specific and competitive dual endothelin receptor antagonist, which can increase cardiac output without increasing heart rate and improve idiopathic pulmonary hypertension by reducing pulmonary and systemic vascular resistance (PAH) The patient's exercise capacity and hemodynamic indicators were approved by the FDA in 2001 for listing in the United States.
In 2018, global sales exceeded 500 million U.
S.
dollars
.
The original research drug was approved to enter the domestic market in 2006.
The currently approved imported dosage forms include tablets and dispersible tablets.
They have successfully entered the national medical insurance catalog through negotiations in 2019 and 2020, respectively.
In 2019, they will be in the terminal of public medical institutions in China and cities in China.
The total sales of this product in the physical pharmacy terminal exceeded 100 million yuan
.
Figure 2: The latest clinical progress of Bosentan tablets from Zhejiang Pharmaceutical Xinchang Pharmaceutical Factory Source: Meinenet.
com China Drug Clinical Trials Announced that Cobosentan tablets were included in the first batch of encouraged imitation catalogs.
At present, 7 domestic pharmaceutical companies have declared 6 categories The imitation listing was approved for clinical use.
Among them, Zhejiang Pharmaceutical Xinchang Pharmaceutical Factory received clinical approval as early as 2014 for the treatment of pulmonary hypertension or pulmonary hypertension caused by scleroderma in patients with WHO grade III and IV primary pulmonary hypertension.
The effectiveness test has been completed
.
Perampanel is Eisai's new anti-epileptic drug.
It was first approved by the FDA in 2012 for the adjuvant treatment of partial seizures in patients with epilepsy over 12 years old.
Regardless of whether the patient is accompanied by secondary full-blown seizures, the variety will be sold globally in 2019 The amount has reached 25.
3 billion yen (approximately 230 million US dollars)
.
The original research drug was approved to enter the Chinese market in 2019, and successfully entered the national medical insurance catalog in 2020.
.
Figure 3: The latest clinical progress of Perampanel tablets of Nanjing Warwick Medical Technology Source: China Drug Clinical Trial Public Library of Meinenet.
At present, a total of 6 domestic pharmaceutical companies have applied for Perampanel tablets category 3.
1 clinical applications and have been approved.
, Nanjing Warwick Medical Technology obtained clinical approval in 2016.
The latest development is applicable to the adjuvant treatment of epilepsy patients with partial epileptic seizures of 4 years and older with or without secondary generalized seizures and applicable to Bioequivalence trials for adjuvant treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years and older are underway
.
Utimes's Buwaxitan (Briracetam) was approved by the European Union EMA and the US FDA in 2016.
It is used as an additional treatment for other drugs to treat partial seizures in patients with epilepsy aged 16 years and older.
Globally in 2019 Sales rose to 220 million euros
.
Figure 4: The latest clinical progress of Buwaxitan tablets.
Source: Meinenet.
com China Drug Clinical Trial Publicity Library Jiangxi Qingfeng Pharmaceutical Co.
, Ltd.
declared a category 3 generic listing and was approved for clinical use in 2019.
The current latest development is the biological adjuvant treatment of partial epilepsy.
The equivalence test has been completed, and the phase III clinical treatment of partial seizure epilepsy in patients aged 4 years and older is underway; Hangzhou Heze Pharmaceutical Technology|Zhejiang Jingxin Pharmaceutical Co.
, Ltd.
applied for 3 types of generic clinical applications and was approved in September 2020.
The latest development is that the bioequivalence test for the treatment of partial-onset epilepsy over 4 years of age has been completed
.
Concluding remarks
encourage the introduction and expansion of the generic drug catalog, aiming to encourage more manufacturers to produce and compete, shorten the application time, optimize the application path, and to a certain extent alleviate the supply of clinically necessary, effective and in short supply drugs
.
Secondly, the development of consistency evaluation of generic drugs in recent years is changing the long-standing "small, chaotic, and scattered" situation of China's generic drugs industry.
Under the normalization of centralized procurement, the share of low-barrier generic drugs will slowly decline in the future, and high barriers.
The share of generic drugs will gradually increase
.
Currently, two batches of generic drugs are encouragedThere are still 15 products in the catalog that have no domestic pharmaceutical companies involved, including the latest products of Roche, GSK, AbbVie, Novo Nordisk and other multinational pharmaceutical companies.
Which domestic pharmaceutical companies will take the initiative in the future? We will continue to follow up and observe
.
Source: China Government Network, Mi Nei.
com database
review data statistics as of March 19, if there are any errors or omissions, please correct me
.
Recently, the National Health Commission and other six departments officially announced the "Second Batch of Encouraged Generic Drugs Catalog", and 17 more varieties were included.
Up to now, the two batches of catalogs have included a total of 50 varieties ( According to the common name + dosage form, there are 56 products)
.
It is reported that the included varieties are drugs whose domestic patents are about to expire but have not yet filed for registration, clinical supply shortages or insufficient competition.
Companies imitating related drugs can receive clinical trials, research on key common technologies, and priority review and approval
.
According to data from Mi Nei.
com, domestic generic drug terminal sales in 2019 amounted to more than 1,000 billion yuan.
Affected by the volume procurement and key monitoring catalog policies, the growth rate of generic drugs continues to slow down.
The entry of high-end generic drugs is expected to stimulate new vitality in the market
.
Encourage imitation to produce results! Chia Tai Tianqing took the lead to win the "first domestic"
In June 2019, the "First Batch of Encouraging Generic Drugs Catalog Recommendation List" was released, and the list of catalogs was officially announced in October of the same year.
In the end, Ripavirin tablets were eliminated and 33 varieties were successfully selected.
.
In December 2020, the "Second Batch of Encouraging Generic Drugs Catalog Recommendation List" was released, and the list was officially announced in March 2021.
Brimonidine timolol eye drops and olaparib tablets were eliminated, and finally 17 varieties were successful Selected
.
Table 1: Status of products with domestic approvals in encouraging imitation drugs Source: One-click search on Mynet.
com According to statistics, 14 of the 56 drugs encouraged to imitation have domestic approvals.
Thanks to policy encouragement, Chia Tai Tianqing Pharmaceutical Co.
, Ltd.
The Group, Zhaoke Pharmaceutical, and Shanghai Xuantai Haimen Pharmaceutical received priority review dividends, and their products were quickly approved for listing
.
According to data from Meinenet.
com, the fosapitant dimeglumine for injection of CP Tianqing Pharmaceutical Group declared for the listing of a 3.
1-category new drug in September 2015 and was included in the priority review in September 2017.
The reason was "before patent expiration.
" One-year drug production application" was approved for marketing in October 2019, becoming the first domestic product of this product
.
With the successive approvals of Hausen and Qilu, 3 domestic companies have been approved.
Shandong Luoxin Pharmaceutical Group's 3 types of generic listing applications have been reviewed and approved.
.
In 2020, CP Tianqing Pharmaceutical Group won the first domestic imitation of AstraZeneca's blockbuster injection fulvestrant
.
The global sales of the original research products in 2018 exceeded 1 billion U.
S.
dollars.
In 2019, the total sales in China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) terminals and Chinese urban physical pharmacies terminals More than 500 million yuan
.
Chia Tai Tianqing Pharmaceutical Group declared 4 types of generic listings in January 2019, and was included in the priority review in April 2020.
The reason was "overseas co-line", and it was approved for listing in August of the same year
.
At present, the 4 types of generic listing applications of Hausen and Hangzhou Jiuyuan Genetic Engineering are under review and approval.
Under the impact of domestic high-end generic drugs, AstraZeneca's market share is in jeopardy
.
Merck’s posaconazole sold for US$740 million globally in 2018.
Currently, the domestic dosage forms that have been imported include oral suspension, enteric-coated tablets and injections
.
In the first batch of encouraged imitation catalogs, injections and enteric-coated tablets were included.
Shanghai Xuantai Haimen Pharmaceuticals submitted posaconazole enteric-coated tablets 4 types of imitation listing applications in February 2019, and was included in the priority review in September of the same year.
, The reason is "overseas co-line", won the first domestic imitation in January 2021
.
Sichuan Kelun Pharmaceutical's 4 types of generic posaconazole enteric-coated tablets are under review and approval, and it is expected to become the second domestic company
.
At present, Merck’s enteric-coated tablets have not yet increased their sales in the domestic market, and domestic high-end imitations are expected to take the lead
.
Zhaoke Pharmaceutical’s Quqianlienier injection was declared for the 4 types of generic marketing in December 2018, and was included in the priority review in June 2019.
The reason was “drugs for rare diseases”.
The first imitation was approved in March 2020
.
Treprostinil is a synthetic prostacyclin drug that can promote vasodilation and inhibit platelet aggregation.
It is used for the symptomatic treatment of pulmonary hypertension.
This product has a long half-life, stable drug structure and convenient use.
It is used as a first-line treatment and Rescue drugs are widely used
.
In addition, although dapsone, mercaptopurine, methotrexate, cyclophosphamide and other varieties currently have domestic approvals, no companies have reviewed them.
Companies are encouraged to develop and produce high-end generic drugs, which will help improve the overall quality of the varieties
.
10 first imitations will be launched, Hengrui, Osaikang.
.
.
to sprint
Table 2: There is no domestic approval, but imitation products are under review.
Source: Meinenet MED2.
0 China Drug Evaluation Database Encourages 10 imitation catalogs The product is about to usher in the first domestic imitation, and the monopoly of domestic market by multinational giants such as Merck, Novartis and Sanofi is expected to be broken
.
As mentioned earlier, posaconazole is Merck’s blockbuster variety, and the injection was approved for import in 2021
.
Osaikang applied for posaconazole injection 3 generic listing application in August 2018, and was included in the priority review in February 2019.
The reason is "the drug production application 1 year before the patent expires".
The current acceptance number is in In the review and approval, Oseikon has the greatest probability of winning the first domestic imitation in terms of application time and policy encouragement
.
Qilu and Qingfeng Pharmaceutical Co.
, Ltd.
applied for 3 types of generic listings in September 2020 and January 2021 respectively, and are currently under review and approval; Simcere Pharmaceuticals|Hangzhou Aoya Biotechnology Co.
, Ltd.
declared 4 types of generic listings in February 2021.
It has been accepted
.
Chengdu Shengdi Pharmaceutical, a subsidiary of Hengrui , applied for the generic listing of tafluprost eye drops in January 2020, and was included in the priority review in May of the same year.
The reason was that "medicine in urgent clinical need and shortage in the market"
.
This product is the first preservative-free prostaglandin analog eye drops, which is clinically mainly used to reduce open-angle glaucoma or ocular hypertension in patients with elevated intraocular pressure.
It is now a negotiated product in the National Medical Insurance Catalogue
.
Mirabegron sustained-release tablets were included in the second batch of encouraged imitation catalogs.
The original research drug company Astellas sold 161.
6 billion yen (approximately US$1.
48 billion) globally in 2019, and was approved to enter the domestic market in 2017.
Successfully entered the national medical insurance catalog in the year of negotiation
.
Huadong Pharmaceutical Group Huayi Pharmaceutical Co.
, Ltd.
declared 4 types of generic listings in October 2019, and was included in the priority review in March 2020.
The reason was "the drug production application one year before the patent expires"
.
Currently, Nanjing Chia Tai Tianqing Pharmaceutical and Sichuan Guowei Pharmaceutical Co.
, Ltd.
applied for the 4 types of generic listing acceptance numbers in September 2020 and January 2021, respectively, are under review and approval
.
Eliglustat capsule is Sanofi-Aventis's blockbuster orphan drug, with global sales of 210 million euros (approximately US$250 million) in 2019.
The original research product has not yet been approved for import
.
Concord Pharmaceuticals|Beijing Gloria Tiancheng Pharmaceutical Technology Co.
, Ltd.
declared for the 3 types of generic listings in April 2019, and was subsequently included in the priority review.
The reason was "rare disease drugs".
Currently, no other companies have applied for listing
.
Sanofi, Johnson & Johnson’s blockbuster products were looted, Kelun, Qingfeng.
.
.
are at the forefront.
Table 3: No domestic approvals, no companies have applied for listing but existing companies have been approved for clinical products.
Source: Minet.
com MED2.
0 There are still 32 products in the catalogue of imitations encouraged by the China Drug Evaluation Database.
There are currently no domestic approval documents and no companies have applied for listing.
17 of these products have been approved for clinical use.
Among them, Sanofi’s cabazitaxel and Pfizer’s demethylation Venlafaxine, Dofetilide and Johnson & Johnson's Bosentan are the hottest, with more than 7 domestic pharmaceutical companies approved for clinical trials
.
Cabazitaxel is a new generation of semi-synthetic taxanes.
A number of in vivo and in vitro studies have shown that it has good anti-tumor effects.
Sanofi was approved by the FDA in 2010 and its global sales exceeded 400 million euros in 2018.
Set a new high in 2020, reaching 540 million euros
.
Figure 1: Kelun’s latest clinical progress of cabazitaxel injection Source: Meinenet China Drug Clinical Trial Public Library At present, a total of 11 domestic pharmaceutical companies have declared and approved the clinical application of Cabazitaxel injection for category 3.
1 new drugs, Sichuan The Kelun Pharmaceutical Research Institute received clinical approval in 2015.
The latest progress is that the phase I clinical trial of advanced solid tumors has been completed, and related trials involving gastric cancer or gastroesophageal junction adenocarcinoma are underway
.
Johnson & Johnson's Bosentan is a specific and competitive dual endothelin receptor antagonist, which can increase cardiac output without increasing heart rate and improve idiopathic pulmonary hypertension by reducing pulmonary and systemic vascular resistance (PAH) The patient's exercise capacity and hemodynamic indicators were approved by the FDA in 2001 for listing in the United States.
In 2018, global sales exceeded 500 million U.
S.
dollars
.
The original research drug was approved to enter the domestic market in 2006.
The currently approved imported dosage forms include tablets and dispersible tablets.
They have successfully entered the national medical insurance catalog through negotiations in 2019 and 2020, respectively.
In 2019, they will be in the terminal of public medical institutions in China and cities in China.
The total sales of this product in the physical pharmacy terminal exceeded 100 million yuan
.
Figure 2: The latest clinical progress of Bosentan tablets from Zhejiang Pharmaceutical Xinchang Pharmaceutical Factory Source: Meinenet.
com China Drug Clinical Trials Announced that Cobosentan tablets were included in the first batch of encouraged imitation catalogs.
At present, 7 domestic pharmaceutical companies have declared 6 categories The imitation listing was approved for clinical use.
Among them, Zhejiang Pharmaceutical Xinchang Pharmaceutical Factory received clinical approval as early as 2014 for the treatment of pulmonary hypertension or pulmonary hypertension caused by scleroderma in patients with WHO grade III and IV primary pulmonary hypertension.
The effectiveness test has been completed
.
Perampanel is Eisai's new anti-epileptic drug.
It was first approved by the FDA in 2012 for the adjuvant treatment of partial seizures in patients with epilepsy over 12 years old.
Regardless of whether the patient is accompanied by secondary full-blown seizures, the variety will be sold globally in 2019 The amount has reached 25.
3 billion yen (approximately 230 million US dollars)
.
The original research drug was approved to enter the Chinese market in 2019, and successfully entered the national medical insurance catalog in 2020.
.
Figure 3: The latest clinical progress of Perampanel tablets of Nanjing Warwick Medical Technology Source: China Drug Clinical Trial Public Library of Meinenet.
At present, a total of 6 domestic pharmaceutical companies have applied for Perampanel tablets category 3.
1 clinical applications and have been approved.
, Nanjing Warwick Medical Technology obtained clinical approval in 2016.
The latest development is applicable to the adjuvant treatment of epilepsy patients with partial epileptic seizures of 4 years and older with or without secondary generalized seizures and applicable to Bioequivalence trials for adjuvant treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years and older are underway
.
Utimes's Buwaxitan (Briracetam) was approved by the European Union EMA and the US FDA in 2016.
It is used as an additional treatment for other drugs to treat partial seizures in patients with epilepsy aged 16 years and older.
Globally in 2019 Sales rose to 220 million euros
.
Figure 4: The latest clinical progress of Buwaxitan tablets.
Source: Meinenet.
com China Drug Clinical Trial Publicity Library Jiangxi Qingfeng Pharmaceutical Co.
, Ltd.
declared a category 3 generic listing and was approved for clinical use in 2019.
The current latest development is the biological adjuvant treatment of partial epilepsy.
The equivalence test has been completed, and the phase III clinical treatment of partial seizure epilepsy in patients aged 4 years and older is underway; Hangzhou Heze Pharmaceutical Technology|Zhejiang Jingxin Pharmaceutical Co.
, Ltd.
applied for 3 types of generic clinical applications and was approved in September 2020.
The latest development is that the bioequivalence test for the treatment of partial-onset epilepsy over 4 years of age has been completed
.
Concluding remarks
encourage the introduction and expansion of the generic drug catalog, aiming to encourage more manufacturers to produce and compete, shorten the application time, optimize the application path, and to a certain extent alleviate the supply of clinically necessary, effective and in short supply drugs
.
Secondly, the development of consistency evaluation of generic drugs in recent years is changing the long-standing "small, chaotic, and scattered" situation of China's generic drugs industry.
Under the normalization of centralized procurement, the share of low-barrier generic drugs will slowly decline in the future, and high barriers.
The share of generic drugs will gradually increase
.
Currently, two batches of generic drugs are encouragedThere are still 15 products in the catalog that have no domestic pharmaceutical companies involved, including the latest products of Roche, GSK, AbbVie, Novo Nordisk and other multinational pharmaceutical companies.
Which domestic pharmaceutical companies will take the initiative in the future? We will continue to follow up and observe
.
Source: China Government Network, Mi Nei.
com database
review data statistics as of March 19, if there are any errors or omissions, please correct me
.
