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OnAugust 12 , the NMPA official website revealed that the review status of the listing application for the third-class generic drug "Azisartan Tablets" of Yangtze River Pharmaceutical was changed to under review, which is expected to be approved in the near future
.
At present, only Hengrui's first copy of this product has been approved in China, and the original research has not yet been listed in China
.
Azilsartan (azilsartan) is a new generation of selective AT1 subtype angiotensin II receptor antagonists (ARBs) antihypertensive drug developed by Takeda Pharmaceuticals.
It antagonizes angiotensin by binding to angiotensin II receptors.
The role of II, thereby inhibiting vasoconstriction, reducing the tension of peripheral blood vessels, in order to achieve antihypertensive effect .
Azilsartan was first developed by Japan's Takeda Pharmaceutical Company and was approved in Japan in January 2012, and was listed under the name "Azilva" .
The company's 2016 annual report shows that Azilva and its series of products will help the company lead the Japanese pharmaceutical market in 2016-2018.
Analysts believe that sales of the drug will continue to grow, with sales of approximately US$749 million in 2022 .
Head ago, azilsartan core patent has expired, the original research is not yet available in the country .
It is understood that the total sales of angiotensin inhibitor drugs in China in 2017 was 9.
6 billion yuan; of which sartan sales accounted for 83.
7%.
At present, there are eprosartan, candesartan medoxomil tablets, and irbe in China.
Sartan, Olmesartan, Valsartan and other 17 single or compound sartan drugs, the total sales of candesartan medoxomil was 624 million in 2017, accounting for 7.
7% of the sales of sartan .
Azilsartan is the second-generation product of candesartan cilexetil.
Azilsartan has better antihypertensive effect and stability, and its safety is equivalent to candesartan cilexetil, and sales are expected to exceed candesartan cilexetil
.
According to the Insight database , as of August 2021, there are 59 domestic companies that are researching Azilsartan tablets
.
Three companies, Yangzijiang Pharmaceutical, Zhaoke Pharmaceutical, and Baiao Pharmaceutical, are in the process of listing applications.
Six companies including Shandong New Times, Ruiyang Pharmaceutical, and Kexing Pharmaceutical are under BE testing.
In addition, Dongyang Sunshine and Simcere Forty-seven pharmaceutical companies such as China Industry and Chengdu Better have received clinical approvals but have not started clinical trials
.
From: Insight database (http://db.
dxy.
cn/v5/) In the
first tier of listing applications, Zhaoke Pharmaceutical and Baiao Pharmaceutical followed Hengrui and reported production before Yangzijiang
.
However, according to the Insight review timeline, Azilsartan of Yangtze River Pharmaceutical entered the administrative approval stage only after the review of the new report task was completed
.
.
At present, only Hengrui's first copy of this product has been approved in China, and the original research has not yet been listed in China
.
Azilsartan (azilsartan) is a new generation of selective AT1 subtype angiotensin II receptor antagonists (ARBs) antihypertensive drug developed by Takeda Pharmaceuticals.
It antagonizes angiotensin by binding to angiotensin II receptors.
The role of II, thereby inhibiting vasoconstriction, reducing the tension of peripheral blood vessels, in order to achieve antihypertensive effect .
Azilsartan was first developed by Japan's Takeda Pharmaceutical Company and was approved in Japan in January 2012, and was listed under the name "Azilva" .
The company's 2016 annual report shows that Azilva and its series of products will help the company lead the Japanese pharmaceutical market in 2016-2018.
Analysts believe that sales of the drug will continue to grow, with sales of approximately US$749 million in 2022 .
Head ago, azilsartan core patent has expired, the original research is not yet available in the country .
It is understood that the total sales of angiotensin inhibitor drugs in China in 2017 was 9.
6 billion yuan; of which sartan sales accounted for 83.
7%.
At present, there are eprosartan, candesartan medoxomil tablets, and irbe in China.
Sartan, Olmesartan, Valsartan and other 17 single or compound sartan drugs, the total sales of candesartan medoxomil was 624 million in 2017, accounting for 7.
7% of the sales of sartan .
Azilsartan is the second-generation product of candesartan cilexetil.
Azilsartan has better antihypertensive effect and stability, and its safety is equivalent to candesartan cilexetil, and sales are expected to exceed candesartan cilexetil
.
According to the Insight database , as of August 2021, there are 59 domestic companies that are researching Azilsartan tablets
.
Three companies, Yangzijiang Pharmaceutical, Zhaoke Pharmaceutical, and Baiao Pharmaceutical, are in the process of listing applications.
Six companies including Shandong New Times, Ruiyang Pharmaceutical, and Kexing Pharmaceutical are under BE testing.
In addition, Dongyang Sunshine and Simcere Forty-seven pharmaceutical companies such as China Industry and Chengdu Better have received clinical approvals but have not started clinical trials
.
From: Insight database (http://db.
dxy.
cn/v5/) In the
first tier of listing applications, Zhaoke Pharmaceutical and Baiao Pharmaceutical followed Hengrui and reported production before Yangzijiang
.
However, according to the Insight review timeline, Azilsartan of Yangtze River Pharmaceutical entered the administrative approval stage only after the review of the new report task was completed
.
