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Medical Network News, April 16th.
Recently, Chengdu Beite product line is dynamic: Azithromycin for injection has been reviewed, dabigatran etexilate capsules have been approved for production and deemed to have been reviewed, and budesonide suspension for inhalation has entered the "under review" ".
.
.
At present, Chengdu Beite has 29 varieties that have been reviewed, 10 of which meet the national centralized procurement requirements, and the company's market share is low or 0; 32 new products are closely focused on the 30 billion market, and 11 varieties are temporarily unavailable.
The first imitation was approved, 5 of which were exclusively reported for production under the new classification by Chengdu Better; 13 innovative drugs (including 10 Class 1 new drugs) are under development, BTK inhibitor BT-1053 tablets, dexmedetomidine hydrochloride nasal spray Drugs, etc.
are already in phase I clinical trials.
Recently, Chengdu Beite product line is dynamic: Azithromycin for injection has been reviewed, dabigatran etexilate capsules have been approved for production and deemed to have been reviewed, and budesonide suspension for inhalation has entered the "under review" ".
.
.
At present, Chengdu Beite has 29 varieties that have been reviewed, 10 of which meet the national centralized procurement requirements, and the company's market share is low or 0; 32 new products are closely focused on the 30 billion market, and 11 varieties are temporarily unavailable.
The first imitation was approved, 5 of which were exclusively reported for production under the new classification by Chengdu Better; 13 innovative drugs (including 10 Class 1 new drugs) are under development, BTK inhibitor BT-1053 tablets, dexmedetomidine hydrochloride nasal spray Drugs, etc.
are already in phase I clinical trials.
29 varieties have been evaluated, and 10 varieties meet the requirements for collective procurement
On March 31, the official website of the State Food and Drug Administration showed that the azithromycin for injection of Chengdu Better (including its subsidiaries, the same below) successfully passed the evaluation, and dabigatran etexilate capsules were approved for production and deemed to have been evaluated.
According to data from Mi Nei.
com, currently 29 varieties of Chengdu Better have passed or deemed to have passed the consistency evaluation.
According to data from Mi Nei.
com, currently 29 varieties of Chengdu Better have passed or deemed to have passed the consistency evaluation.
Chengdu Better Reviews
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
The first review of 9 varieties, cefdinir granules, propofol tenofovir fumarate tablets as the first imitation + the first review, ampicillin sodium for injection, cefodizime sodium for injection, ketorolac tromethamine Four varieties of alcohol injection and fluconazole capsules have been reviewed exclusively.
In terms of dosage form, among the approved varieties of Chengdu Better, 13 are injections and 3 are inhalants; from the treatment field, 29 varieties cover 8 treatment categories, focusing on systemic anti-infective drugs.
12 varieties have been reviewed.
12 varieties have been reviewed.
Among the 29 over-rated varieties, 14 varieties have been included in the national centralized procurement, and 10 of the remaining 15 varieties have met the requirements for centralized procurement.
They are dabigatran etexilate capsules, ceftazidime for injection, and compound for inhalation.
Ipratropium Bromide Solution, Fasudil Hydrochloride Injection, Tirofiban Hydrochloride Sodium Chloride Injection, Lipoic Acid Injection, Cefdinir Granules, Ipratropium Bromide Solution for Inhalation, Propofol Fumarate Tenofovir tablets, Azithromycin for injection.
They are dabigatran etexilate capsules, ceftazidime for injection, and compound for inhalation.
Ipratropium Bromide Solution, Fasudil Hydrochloride Injection, Tirofiban Hydrochloride Sodium Chloride Injection, Lipoic Acid Injection, Cefdinir Granules, Ipratropium Bromide Solution for Inhalation, Propofol Fumarate Tenofovir tablets, Azithromycin for injection.
According to data from Mi Nei.
com, in the first half of 2020 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, Chengdu Better has a relatively low market share in the above 10 varieties.
Or 0.
com, in the first half of 2020 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, Chengdu Better has a relatively low market share in the above 10 varieties.
Or 0.
15 consistent evaluation varieties are under review, and 5 are expected to be the first to be reviewed
On April 12, the supplementary application for consistency evaluation of lidocaine hydrochloride injection submitted by Chengdu Better was accepted by the CDE, and there was no enterprise review for this product.
At present, the company has submitted 30 supplementary applications for consistency evaluation, and 15 of them have passed the consistency evaluation.
Tirofiban Hydrochloride Sodium Chloride Injection and Cefixime Capsules were the first to have been evaluated, and Ampicillin Sodium for Injection, Injection Exclusively reviewed with cefodizime sodium and fluconazole capsules.
At present, the company has submitted 30 supplementary applications for consistency evaluation, and 15 of them have passed the consistency evaluation.
Tirofiban Hydrochloride Sodium Chloride Injection and Cefixime Capsules were the first to have been evaluated, and Ampicillin Sodium for Injection, Injection Exclusively reviewed with cefodizime sodium and fluconazole capsules.
Chengdu Beite’s Supplementary Application Varieties for Consistency Evaluation
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Of the 15 consistency evaluation supplementary application varieties under review, 5 have sales of more than 1 billion yuan at the terminal of Chinese public medical institutions in 2019, and the annual sales of the two major varieties of ceftriaxone sodium for injection and omeprazole sodium for injection exceed 3 billion yuan.
The 11 varieties under review have not yet been evaluated by the enterprise.
The 5 varieties of dexamethasone sodium phosphate injection, cefmetazole sodium for injection, ozagrel sodium for injection, amikacin sulfate injection, and digoxin tablets are composed of Chengdu Better is the first company to declare consistency evaluation, among which digoxin tablets and amikacin sulfate injection are the exclusive declarations.
The 5 varieties of dexamethasone sodium phosphate injection, cefmetazole sodium for injection, ozagrel sodium for injection, amikacin sulfate injection, and digoxin tablets are composed of Chengdu Better is the first company to declare consistency evaluation, among which digoxin tablets and amikacin sulfate injection are the exclusive declarations.
32 new products focus on the 30 billion market, and 11 varieties are the first to imitate
On April 1, Chengdu Better’s application for the listing of dapagliflozin tablets submitted for imitation of category 4 was accepted by CDE; on March 31, the company’s category 4 generic drug inhalation budesonide suspension entered the "under review".
The total sales volume of this product in China's public medical institutions and physical pharmacies in cities in China in 2019 was nearly 8 billion yuan.
The total sales volume of this product in China's public medical institutions and physical pharmacies in cities in China in 2019 was nearly 8 billion yuan.
At present, Chengdu Beite has 46 varieties reported for production under the newly registered classification, covering 9 major categories of treatment, focusing on the two major therapeutic areas of respiratory system drugs (13 varieties) and systemic anti-infective drugs (9 varieties).
14 varieties have been approved for production and deemed to have passed the consistency evaluation.
Among them, cefdinir granules, propofol tenofovir fumarate tablets, duloxetine hydrochloride enteric-coated capsules were the first to have been evaluated, and ketorolac ambutene Triol injection has been reviewed exclusively.
14 varieties have been approved for production and deemed to have passed the consistency evaluation.
Among them, cefdinir granules, propofol tenofovir fumarate tablets, duloxetine hydrochloride enteric-coated capsules were the first to have been evaluated, and ketorolac ambutene Triol injection has been reviewed exclusively.
The total market size of the 32 varieties under review in China's public medical institutions in 2019 is close to 30 billion yuan, of which 10 have annual sales exceeding 1 billion.
New classified newspaper product varieties under review by Chengdu Better
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
No first imitation (including the first imitation of the dosage form) of 11 varieties has been approved, and many of them have global sales of more than 1 billion U.
S.
dollars, including AstraZeneca’s dapagliflozin, Novartis’s sacubatril and valsartan, Gilead’s emtricitabine propofol tenofovir and others will have global sales of US$1.
964 billion, US$2.
497 billion, and US$1.
86 billion in 2020, respectively.
S.
dollars, including AstraZeneca’s dapagliflozin, Novartis’s sacubatril and valsartan, Gilead’s emtricitabine propofol tenofovir and others will have global sales of US$1.
964 billion, US$2.
497 billion, and US$1.
86 billion in 2020, respectively.
Chengdu Better is under review and there is no new classified product category that has been approved for the first imitation
Note: The sales are less than 100 million yuan with the symbol-
Source: Minet database
Iopromide injection, emtricitabine propofol tenofovir tablets, budesonide formoterol inhalation aerosol, fluticasone propionate inhalation aerosol, budesonide nasal spray, 5 varieties by Chengdu times It is exclusively reported to be produced under a new classification.
Among them, Bayer's iopromide injection has sales of more than 1 billion yuan in China's public medical institutions in 2019.
Among them, Bayer's iopromide injection has sales of more than 1 billion yuan in China's public medical institutions in 2019.
In terms of innovative drugs, Better Pharmaceuticals has 10 national Class 1 new drugs including BT-1053 and BT-101, and 3 improved new drugs including remazolam hydrobromide for injection and dexmedetomidine hydrochloride nasal spray.
In different stages of development.
In different stages of development.
BT-1053, a new class 1 drug, is undergoing phase I clinical trials for relapsed/refractory B-cell non-Hodgkin’s lymphoma.
This is a BTK inhibitor; a modified new drug dexmedetomidine hydrochloride nasal spray Phase I clinical is being carried out for sedation of patients undergoing general anesthesia and sedation of non-intubated patients.
This is a BTK inhibitor; a modified new drug dexmedetomidine hydrochloride nasal spray Phase I clinical is being carried out for sedation of patients undergoing general anesthesia and sedation of non-intubated patients.
Source: Minet database
Note: The statistics are as of April 13, if there are any omissions, please correct me!
Medical Network News, April 16th.
Recently, Chengdu Beite product line is dynamic: Azithromycin for injection has been reviewed, dabigatran etexilate capsules have been approved for production and deemed to have been reviewed, and budesonide suspension for inhalation has entered the "under review" ".
.
.
At present, Chengdu Beite has 29 varieties that have been reviewed, 10 of which meet the national centralized procurement requirements, and the company's market share is low or 0; 32 new products are closely focused on the 30 billion market, and 11 varieties are temporarily unavailable.
The first imitation was approved, 5 of which were exclusively reported for production under the new classification by Chengdu Better; 13 innovative drugs (including 10 Class 1 new drugs) are under development, BTK inhibitor BT-1053 tablets, dexmedetomidine hydrochloride nasal spray Drugs, etc.
are already in phase I clinical trials.
Recently, Chengdu Beite product line is dynamic: Azithromycin for injection has been reviewed, dabigatran etexilate capsules have been approved for production and deemed to have been reviewed, and budesonide suspension for inhalation has entered the "under review" ".
.
.
At present, Chengdu Beite has 29 varieties that have been reviewed, 10 of which meet the national centralized procurement requirements, and the company's market share is low or 0; 32 new products are closely focused on the 30 billion market, and 11 varieties are temporarily unavailable.
The first imitation was approved, 5 of which were exclusively reported for production under the new classification by Chengdu Better; 13 innovative drugs (including 10 Class 1 new drugs) are under development, BTK inhibitor BT-1053 tablets, dexmedetomidine hydrochloride nasal spray Drugs, etc.
are already in phase I clinical trials.
29 varieties have been evaluated, and 10 varieties meet the requirements for collective procurement
On March 31, the official website of the State Food and Drug Administration showed that the azithromycin for injection of Chengdu Better (including its subsidiaries, the same below) successfully passed the evaluation, and dabigatran etexilate capsules were approved for production and deemed to have been evaluated.
According to data from Mi Nei.
com, currently 29 varieties of Chengdu Better have passed or deemed to have passed the consistency evaluation.
According to data from Mi Nei.
com, currently 29 varieties of Chengdu Better have passed or deemed to have passed the consistency evaluation.
Chengdu Better Reviews
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
The first review of 9 varieties, cefdinir granules, propofol tenofovir fumarate tablets as the first imitation + the first review, ampicillin sodium for injection, cefodizime sodium for injection, ketorolac tromethamine Four varieties of alcohol injection and fluconazole capsules have been reviewed exclusively.
In terms of dosage form, among the approved varieties of Chengdu Better, 13 are injections and 3 are inhalants; from the treatment field, 29 varieties cover 8 treatment categories, focusing on systemic anti-infective drugs.
12 varieties have been reviewed.
12 varieties have been reviewed.
Among the 29 over-rated varieties, 14 varieties have been included in the national centralized procurement, and 10 of the remaining 15 varieties have met the requirements for centralized procurement.
They are dabigatran etexilate capsules, ceftazidime for injection, and compound for inhalation.
Ipratropium Bromide Solution, Fasudil Hydrochloride Injection, Tirofiban Hydrochloride Sodium Chloride Injection, Lipoic Acid Injection, Cefdinir Granules, Ipratropium Bromide Solution for Inhalation, Propofol Fumarate Tenofovir tablets, Azithromycin for injection.
They are dabigatran etexilate capsules, ceftazidime for injection, and compound for inhalation.
Ipratropium Bromide Solution, Fasudil Hydrochloride Injection, Tirofiban Hydrochloride Sodium Chloride Injection, Lipoic Acid Injection, Cefdinir Granules, Ipratropium Bromide Solution for Inhalation, Propofol Fumarate Tenofovir tablets, Azithromycin for injection.
，2020、、（），100。
15，5
412，CDE，。30，15，、，、、。
：MED2.
0
0
155201910，、230。
11，、、、、5，、。
32300，11
41，4CDE；331，4“”，201980。
，46，9，（13）、（9）。14，、、，。
322019300，1010。
：MED2.
0
0
11（），10，、、，202019.
64、24.
97、18.
6。
64、24.
97、18.
6。
：1-
：
、、、、5，201910。
，BT-1053、BT-101101，、3。
1BT-1053I，/B，BTK；I，、。
：
：413，，！
Medical Network News, April 16th.
Recently, Chengdu Beite product line is dynamic: Azithromycin for injection has been reviewed, dabigatran etexilate capsules have been approved for production and deemed to have been reviewed, and budesonide suspension for inhalation has entered the "under review" ".
.
.
At present, Chengdu Beite has 29 varieties that have been reviewed, 10 of which meet the national centralized procurement requirements, and the company's market share is low or 0; 32 new products are closely focused on the 30 billion market, and 11 varieties are temporarily unavailable.
The first imitation was approved, 5 of which were exclusively reported for production under the new classification by Chengdu Better; 13 innovative drugs (including 10 Class 1 new drugs) are under development, BTK inhibitor BT-1053 tablets, dexmedetomidine hydrochloride nasal spray Drugs, etc.
are already in phase I clinical trials.
Recently, Chengdu Beite product line is dynamic: Azithromycin for injection has been reviewed, dabigatran etexilate capsules have been approved for production and deemed to have been reviewed, and budesonide suspension for inhalation has entered the "under review" ".
.
.
At present, Chengdu Beite has 29 varieties that have been reviewed, 10 of which meet the national centralized procurement requirements, and the company's market share is low or 0; 32 new products are closely focused on the 30 billion market, and 11 varieties are temporarily unavailable.
The first imitation was approved, 5 of which were exclusively reported for production under the new classification by Chengdu Better; 13 innovative drugs (including 10 Class 1 new drugs) are under development, BTK inhibitor BT-1053 tablets, dexmedetomidine hydrochloride nasal spray Drugs, etc.
are already in phase I clinical trials.
29 varieties have been evaluated, and 10 varieties meet the requirements for collective procurement
29 varieties have been evaluated, and 10 varieties meet the requirements for collective procurement On March 31, the official website of the State Food and Drug Administration showed that the azithromycin for injection of Chengdu Better (including its subsidiaries, the same below) successfully passed the evaluation, and dabigatran etexilate capsules were approved for production and deemed to have been evaluated.
According to data from Mi Nei.
com, currently 29 varieties of Chengdu Better have passed or deemed to have passed the consistency evaluation.
According to data from Mi Nei.
com, currently 29 varieties of Chengdu Better have passed or deemed to have passed the consistency evaluation.
Chengdu Better Reviews
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
The first review of 9 varieties, cefdinir granules, propofol tenofovir fumarate tablets as the first imitation + the first review, ampicillin sodium for injection, cefodizime sodium for injection, ketorolac tromethamine Four varieties of alcohol injection and fluconazole capsules have been reviewed exclusively.
In terms of dosage form, among the approved varieties of Chengdu Better, 13 are injections and 3 are inhalants; from the treatment field, 29 varieties cover 8 treatment categories, focusing on systemic anti-infective drugs.
12 varieties have been reviewed.
12 varieties have been reviewed.
Among the 29 over-rated varieties, 14 varieties have been included in the national centralized procurement, and 10 of the remaining 15 varieties have met the requirements for centralized procurement.
They are dabigatran etexilate capsules, ceftazidime for injection, and compound for inhalation.
Ipratropium Bromide Solution, Fasudil Hydrochloride Injection, Tirofiban Hydrochloride Sodium Chloride Injection, Lipoic Acid Injection, Cefdinir Granules, Ipratropium Bromide Solution for Inhalation, Propofol Fumarate Tenofovir tablets, Azithromycin for injection.
They are dabigatran etexilate capsules, ceftazidime for injection, and compound for inhalation.
Ipratropium Bromide Solution, Fasudil Hydrochloride Injection, Tirofiban Hydrochloride Sodium Chloride Injection, Lipoic Acid Injection, Cefdinir Granules, Ipratropium Bromide Solution for Inhalation, Propofol Fumarate Tenofovir tablets, Azithromycin for injection.
According to data from Mi Nei.
com, in the first half of 2020 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, Chengdu Better has a relatively low market share in the above 10 varieties.
Or 0.
Hospital hospital hospitalcom, in the first half of 2020 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, Chengdu Better has a relatively low market share in the above 10 varieties.
Or 0.
15 consistent evaluation varieties are under review, and 5 are expected to be the first to be reviewed
15 consistent evaluation varieties are under review, and 5 are expected to be the first to be reviewed On April 12, the supplementary application for consistency evaluation of lidocaine hydrochloride injection submitted by Chengdu Better was accepted by the CDE, and there was no enterprise review for this product.
At present, the company has submitted 30 supplementary applications for consistency evaluation, and 15 of them have passed the consistency evaluation.
Tirofiban Hydrochloride Sodium Chloride Injection and Cefixime Capsules were the first to have been evaluated, and Ampicillin Sodium for Injection, Injection Exclusively reviewed with cefodizime sodium and fluconazole capsules.
Enterprise business enterpriseAt present, the company has submitted 30 supplementary applications for consistency evaluation, and 15 of them have passed the consistency evaluation.
Tirofiban Hydrochloride Sodium Chloride Injection and Cefixime Capsules were the first to have been evaluated, and Ampicillin Sodium for Injection, Injection Exclusively reviewed with cefodizime sodium and fluconazole capsules.
Chengdu Beite’s Supplementary Application Varieties for Consistency Evaluation
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
Of the 15 consistency evaluation supplementary application varieties under review, 5 have sales of more than 1 billion yuan at the terminal of Chinese public medical institutions in 2019, and the annual sales of the two major varieties of ceftriaxone sodium for injection and omeprazole sodium for injection exceed 3 billion yuan.
The 11 varieties under review have not yet been evaluated by the enterprise.
The 5 varieties of dexamethasone sodium phosphate injection, cefmetazole sodium for injection, ozagrel sodium for injection, amikacin sulfate injection, and digoxin tablets are composed of Chengdu Better is the first company to declare consistency evaluation, among which digoxin tablets and amikacin sulfate injection are the exclusive declarations.
The 5 varieties of dexamethasone sodium phosphate injection, cefmetazole sodium for injection, ozagrel sodium for injection, amikacin sulfate injection, and digoxin tablets are composed of Chengdu Better is the first company to declare consistency evaluation, among which digoxin tablets and amikacin sulfate injection are the exclusive declarations.
32 new products focus on the 30 billion market, and 11 varieties are the first to imitate
32 new products focus on the 30 billion market, and 11 varieties are the first to imitate On April 1, Chengdu Better’s application for the listing of dapagliflozin tablets submitted for imitation of category 4 was accepted by CDE; on March 31, the company’s category 4 generic drug inhalation budesonide suspension entered the "under review".
The total sales volume of this product in China's public medical institutions and physical pharmacies in cities in China in 2019 was nearly 8 billion yuan.
Pharmacy pharmacy pharmacyThe total sales volume of this product in China's public medical institutions and physical pharmacies in cities in China in 2019 was nearly 8 billion yuan.
At present, Chengdu Beite has 46 varieties reported for production under the newly registered classification, covering 9 major categories of treatment, focusing on the two major therapeutic areas of respiratory system drugs (13 varieties) and systemic anti-infective drugs (9 varieties).
14 varieties have been approved for production and deemed to have passed the consistency evaluation.
Among them, cefdinir granules, propofol tenofovir fumarate tablets, duloxetine hydrochloride enteric-coated capsules were the first to have been evaluated, and ketorolac ambutene Triol injection has been reviewed exclusively.
14 varieties have been approved for production and deemed to have passed the consistency evaluation.
Among them, cefdinir granules, propofol tenofovir fumarate tablets, duloxetine hydrochloride enteric-coated capsules were the first to have been evaluated, and ketorolac ambutene Triol injection has been reviewed exclusively.
The total market size of the 32 varieties under review in China's public medical institutions in 2019 is close to 30 billion yuan, of which 10 have annual sales exceeding 1 billion.
New classified newspaper product varieties under review by Chengdu Better
Source: Meinenet MED2.
0 Chinese Drug Evaluation Database
0 Chinese Drug Evaluation Database
No first imitation (including the first imitation of the dosage form) of 11 varieties has been approved, and many of them have global sales of more than 1 billion U.
S.
dollars, including AstraZeneca’s dapagliflozin, Novartis’s sacubatril and valsartan, Gilead’s emtricitabine propofol tenofovir and others will have global sales of US$1.
964 billion, US$2.
497 billion, and US$1.
86 billion in 2020, respectively.
S.
dollars, including AstraZeneca’s dapagliflozin, Novartis’s sacubatril and valsartan, Gilead’s emtricitabine propofol tenofovir and others will have global sales of US$1.
964 billion, US$2.
497 billion, and US$1.
86 billion in 2020, respectively.
Chengdu Better is under review and there is no new classified product category that has been approved for the first imitation
Note: The sales are less than 100 million yuan with the symbol-
Source: Minet database
Iopromide injection, emtricitabine propofol tenofovir tablets, budesonide formoterol inhalation aerosol, fluticasone propionate inhalation aerosol, budesonide nasal spray, 5 varieties by Chengdu times It is exclusively reported to be produced under a new classification.
Among them, Bayer's iopromide injection has sales of more than 1 billion yuan in China's public medical institutions in 2019.
Among them, Bayer's iopromide injection has sales of more than 1 billion yuan in China's public medical institutions in 2019.
In terms of innovative drugs, Better Pharmaceuticals has 10 national Class 1 new drugs including BT-1053 and BT-101, and 3 improved new drugs including remazolam hydrobromide for injection and dexmedetomidine hydrochloride nasal spray.
In different stages of development.
In different stages of development.
BT-1053, a new class 1 drug, is undergoing phase I clinical trials for relapsed/refractory B-cell non-Hodgkin’s lymphoma.
This is a BTK inhibitor; a modified new drug dexmedetomidine hydrochloride nasal spray Phase I clinical is being carried out for sedation of patients undergoing general anesthesia and sedation of non-intubated patients.
This is a BTK inhibitor; a modified new drug dexmedetomidine hydrochloride nasal spray Phase I clinical is being carried out for sedation of patients undergoing general anesthesia and sedation of non-intubated patients.
Source: Minet database
Note: The statistics are as of April 13, if there are any omissions, please correct me!
