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As a well-known private enterprise in China, Yangzijiang has achieved a lot in 2021: it won the first class 1 new drug, ranked first in the number of approved generic drugs, and the number of new generic drug applications was NO.
1.
At present, there are 18 innovative drugs in Yangtze River (14 are category 1 new drugs) in the stage of clinical application and above; 94 varieties have been reviewed (23 are the first ones), and 11 varieties (10 drugs) are planned to be included in the seventh batch of centralized procurement ; 85 new classification application varieties are under review, and 25 have not been approved for the first imitation
.
It has won 27 new products and 25 varieties of the first imitation rice.
Intranet data shows that in 2021, the State Food and Drug Administration has approved more than 900 domestic generic drug approvals (including generic 3/4/6 categories, not Including APIs), the number of approved varieties of Yangtze River, Qilu, Sino Biopharmaceutical, Kelun and CSPC ranks among the top five
.
In 2021, a total of 27 generic drugs in Yangtze River have been approved for the first time, ranking first in total, doubling from 13 in 2020
.
26 of the 27 generic drugs were reported for production under the new classification, and they were deemed to have been reviewed after being approved for production
.
In 2021, Yangtze River's first approved drug product source: Minet.
com MED2.
0 China Drug Evaluation Database.
In terms of generic drug application, Yangtze River submitted nearly 40 generic drug listing applications in 2021, continuing to lead other domestic companies
.
Up to now, the company's new classification declaration (including clinical/marketing) and 85 varieties are under review (excluding those that have been approved, withdrawn/disapproved)
.
No first imitation (including the first imitation in dosage form) of 25 varieties has been approved for marketing.
Regorafenib Tablets, Tedizolid Phosphate for Injection, Rupatadine Fumarate Oral Liquid, Neconazole Hydrochloride Cream, Mesylate 14 varieties such as Safinamide Tablets, Sodium Acetate Ringer's Dextrose Injection, Sodium Potassium Magnesium Sulfate Oral Solution were first or exclusively declared by Yangzijiang under new classification
.
Yangzijiang is under review and there is no new category application for the first imitation approved.
Note: The first/exclusive application source with * is: Minet MED2.
0 China Drug Evaluation Database Many of the major varieties sold globally, including Daiichi Sankyo Edoxaban from Amgen, Carfilzomib from Amgen, and Sugammadex from Merck & Co.
will all have global sales of more than $1 billion in 2020
.
On February 9, Yangzijiang's ropivacaine hydrochloride injection was approved for production and deemed to have been reviewed
.
According to the data of Minet.
com, 94 varieties of the company have passed or deemed to pass the consistency evaluation, of which 39 are injections
.
In terms of therapeutic areas, 94 varieties cover 11 major categories of treatment, focusing on systemic anti-infective drugs (17 varieties), anti-tumor and immunomodulatory agents (13 varieties), digestive system and metabolic drugs (12 varieties) etc.
_ Yangzijiang Over-evaluation Note: The first/exclusive over-evaluation source with * is: 23 of the 94 over-evaluated varieties in the MED2.
0 China Drug Evaluation Database are the first over-evaluation, among which tamoxifen citrate tablets, Methylcobalamin injection, entecavir oral liquid, risedronate sodium tablets and other varieties are exclusive reviews
.
The rich variety of over-rated varieties has made the Yangtze River fruitful in the national centralized procurement
.
Among the five batches of centralized procurement that have been implemented, 2, 4, 7, 8 and 10 varieties of Yangtze River have won the bid respectively, with a total of 31 varieties
.
A few days ago, the seventh batch of centralized procurement began to report, and 11 over-evaluated varieties (10 generic drugs) in Yangtze River were listed
.
Yangtze River plans to be included in the seventh batch of drugs for centralized procurement.
Note: sales below 100 million yuan are represented by *.
Source: Minet database, Hunan Medical Insurance Bureau There are 14 qualified companies, and the terminal sales of this product in China's public medical institutions will exceed 6 billion yuan in 2020; from the perspective of product competition, Yangzijiang is in tirofiban injection, nifedipine sustained-release and controlled-release dosage form, and Lula hydrochloride.
The market share of 5 varieties of Xanthone tablets, afatinib oral normal-release dosage form, and metformin vildagliptin oral normal-release dosage form is less than 1%, and the market is waiting to be developed
.
Traditional Chinese medicine, chemical medicine, and biological medicine go hand in hand, and 18 innovative drugs are on the way.
At present, the innovative medicines under development by Yangzijiang are mainly small-molecule chemical medicines, but the research and development of Chinese patent medicines is progressing in an orderly manner, and the exploration of biological medicines is also gradually in progress
.
According to data from Minet.
com, according to incomplete statistics, the company currently has 18 innovative drugs that are in the clinical application stage and above (excluding new indications for new drugs already on the market)
.
Source of Yangtze River's innovative drugs under development : Minet.
com China Drug Clinical Trials Publicity Library In addition, three new class 1 drugs, ucnafil (PDE-5 inhibitor), filsurazan (new PPI inhibitor), and YZJ-1139 (orexin receptor OX1/OX2 antagonist), have entered Phase III clinical trials , the market can be expected; YZJ-0673 is a pan-PI3K inhibitor in Phase I clinical trials, and no drug with the same target has been approved for marketing in China
.
In the field of biopharmaceuticals, Yangzijiang's new drugs under development are mainly introduced, including a class 1 new drug 8MW0511, which is a long-acting rhG-CSF with indications for neutropenia in Phase II/III clinical trials; MW11 is a PD- 1 monoclonal antibody, the domestic PD-1 monoclonal antibody market in 2020 has exceeded 10 billion yuan
.
In the field of proprietary Chinese medicines, Ganmao Shuangjie Granules for influenza has entered Phase III clinical trials, 1.
1 new drugs Qingchang Wenzhong Tablets and 2.
3 new drugs Sanfeng Tongqiao Dropping Pills have been approved for clinical use
.
1.
At present, there are 18 innovative drugs in Yangtze River (14 are category 1 new drugs) in the stage of clinical application and above; 94 varieties have been reviewed (23 are the first ones), and 11 varieties (10 drugs) are planned to be included in the seventh batch of centralized procurement ; 85 new classification application varieties are under review, and 25 have not been approved for the first imitation
.
It has won 27 new products and 25 varieties of the first imitation rice.
Intranet data shows that in 2021, the State Food and Drug Administration has approved more than 900 domestic generic drug approvals (including generic 3/4/6 categories, not Including APIs), the number of approved varieties of Yangtze River, Qilu, Sino Biopharmaceutical, Kelun and CSPC ranks among the top five
.
In 2021, a total of 27 generic drugs in Yangtze River have been approved for the first time, ranking first in total, doubling from 13 in 2020
.
26 of the 27 generic drugs were reported for production under the new classification, and they were deemed to have been reviewed after being approved for production
.
In 2021, Yangtze River's first approved drug product source: Minet.
com MED2.
0 China Drug Evaluation Database.
In terms of generic drug application, Yangtze River submitted nearly 40 generic drug listing applications in 2021, continuing to lead other domestic companies
.
Up to now, the company's new classification declaration (including clinical/marketing) and 85 varieties are under review (excluding those that have been approved, withdrawn/disapproved)
.
No first imitation (including the first imitation in dosage form) of 25 varieties has been approved for marketing.
Regorafenib Tablets, Tedizolid Phosphate for Injection, Rupatadine Fumarate Oral Liquid, Neconazole Hydrochloride Cream, Mesylate 14 varieties such as Safinamide Tablets, Sodium Acetate Ringer's Dextrose Injection, Sodium Potassium Magnesium Sulfate Oral Solution were first or exclusively declared by Yangzijiang under new classification
.
Yangzijiang is under review and there is no new category application for the first imitation approved.
Note: The first/exclusive application source with * is: Minet MED2.
0 China Drug Evaluation Database Many of the major varieties sold globally, including Daiichi Sankyo Edoxaban from Amgen, Carfilzomib from Amgen, and Sugammadex from Merck & Co.
will all have global sales of more than $1 billion in 2020
.
On February 9, Yangzijiang's ropivacaine hydrochloride injection was approved for production and deemed to have been reviewed
.
According to the data of Minet.
com, 94 varieties of the company have passed or deemed to pass the consistency evaluation, of which 39 are injections
.
In terms of therapeutic areas, 94 varieties cover 11 major categories of treatment, focusing on systemic anti-infective drugs (17 varieties), anti-tumor and immunomodulatory agents (13 varieties), digestive system and metabolic drugs (12 varieties) etc.
_ Yangzijiang Over-evaluation Note: The first/exclusive over-evaluation source with * is: 23 of the 94 over-evaluated varieties in the MED2.
0 China Drug Evaluation Database are the first over-evaluation, among which tamoxifen citrate tablets, Methylcobalamin injection, entecavir oral liquid, risedronate sodium tablets and other varieties are exclusive reviews
.
The rich variety of over-rated varieties has made the Yangtze River fruitful in the national centralized procurement
.
Among the five batches of centralized procurement that have been implemented, 2, 4, 7, 8 and 10 varieties of Yangtze River have won the bid respectively, with a total of 31 varieties
.
A few days ago, the seventh batch of centralized procurement began to report, and 11 over-evaluated varieties (10 generic drugs) in Yangtze River were listed
.
Yangtze River plans to be included in the seventh batch of drugs for centralized procurement.
Note: sales below 100 million yuan are represented by *.
Source: Minet database, Hunan Medical Insurance Bureau There are 14 qualified companies, and the terminal sales of this product in China's public medical institutions will exceed 6 billion yuan in 2020; from the perspective of product competition, Yangzijiang is in tirofiban injection, nifedipine sustained-release and controlled-release dosage form, and Lula hydrochloride.
The market share of 5 varieties of Xanthone tablets, afatinib oral normal-release dosage form, and metformin vildagliptin oral normal-release dosage form is less than 1%, and the market is waiting to be developed
.
Traditional Chinese medicine, chemical medicine, and biological medicine go hand in hand, and 18 innovative drugs are on the way.
At present, the innovative medicines under development by Yangzijiang are mainly small-molecule chemical medicines, but the research and development of Chinese patent medicines is progressing in an orderly manner, and the exploration of biological medicines is also gradually in progress
.
According to data from Minet.
com, according to incomplete statistics, the company currently has 18 innovative drugs that are in the clinical application stage and above (excluding new indications for new drugs already on the market)
.
Source of Yangtze River's innovative drugs under development : Minet.
com China Drug Clinical Trials Publicity Library In addition, three new class 1 drugs, ucnafil (PDE-5 inhibitor), filsurazan (new PPI inhibitor), and YZJ-1139 (orexin receptor OX1/OX2 antagonist), have entered Phase III clinical trials , the market can be expected; YZJ-0673 is a pan-PI3K inhibitor in Phase I clinical trials, and no drug with the same target has been approved for marketing in China
.
In the field of biopharmaceuticals, Yangzijiang's new drugs under development are mainly introduced, including a class 1 new drug 8MW0511, which is a long-acting rhG-CSF with indications for neutropenia in Phase II/III clinical trials; MW11 is a PD- 1 monoclonal antibody, the domestic PD-1 monoclonal antibody market in 2020 has exceeded 10 billion yuan
.
In the field of proprietary Chinese medicines, Ganmao Shuangjie Granules for influenza has entered Phase III clinical trials, 1.
1 new drugs Qingchang Wenzhong Tablets and 2.
3 new drugs Sanfeng Tongqiao Dropping Pills have been approved for clinical use
.
