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Recently, CSPC has registered to start the BE clinical trial of roxadustat, which is also the fifth domestic company to enter clinical development of roxadustat generic drugs
.
The data show that roxadustat was discovered by Fibrogen, which is an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor
.
It can promote endogenous erythropoietin production, improve iron absorption and mobilization, and downregulate iron by inhibiting the ubiquitination degradation of hypoxia-inducible factor (HIF)
.
Roxadustat has been shown to maintain erythropoietin levels at or near the normal physiological range in multiple subgroups of patients with chronic kidney disease, thereby increasing red blood cell counts, without being affected by inflammatory states, and by avoiding intravenous iron supplementation
.
It is understood that Fibrex has cooperated extensively with major pharmaceutical companies to promote roxadustat
.
Among them, AstraZeneca is responsible for the development of the product in China, the United States, other markets in the Americas, Australia and New Zealand, and Southeast Asia
.
In December 2018, roxadustat entered the Chinese market through AstraZeneca and was approved for the treatment of anemia in patients with chronic kidney disease on dialysis.
Symptoms, and successfully entered the medical insurance catalog
.
The limited use of the 2021 version is for anemia caused by chronic kidney disease (CKD), including dialysis and non-dialysis patients
.
Thanks to the increase in medical insurance, roxadustat's domestic sales growth has accelerated in recent years
.
According to data from Minet.
com, in 2020, the product has exceeded 400 million yuan in terminals of public medical institutions in China, and the sales in the first half of 2021 will reach 500 million yuan, far exceeding the annual sales of the previous year.
Except in urban public hospitals, The market for this product in county-level public hospitals is also growing rapidly
.
According to data, in 2021, the sales of this product in the domestic market will exceed 1 billion yuan
.
AstraZeneca's financial report in 2021 shows that roxadustat's sales performance in 2021 will mainly come from the Chinese market, which will contribute US$174 million in revenue this year, in addition to a US$6 million cooperation share
.
It is worth mentioning that the original research drug is facing the challenge of patent expiration.
It is understood that the patent of roxadustat compound will partially expire in 2024, the patent of crystal form will expire in 2033, and the patent of preparation will also expire in 2034.
due
.
Relevant statistics show that, in addition to CSPC, there are four other companies including Chia Tai Tianqing, Jiangsu Wanbang, Jiangxi Shanxiang Pharmaceutical, and Chengdu Beite that have initiated BE trials of roxadustat generic drugs
.
Among them, Chia Tai Tianqing registered to start the BE trial as early as March 2020
.
In 2021, three companies, Jiangsu Wanbang, Shanxiang Pharmaceutical, and Chengdu Beite, will also start BE trials one after another
.
Judging from the clinical trial status, Chia Tai Tianqing, Jiangsu Wanbang, and Jiangxi Shanxiang Pharmaceutical have completed BE trials, while Chengdu Bite is still in progress
.
It is foreseeable that with the approval of these generic drugs, AstraZeneca's products will be impacted, and the market structure is expected to change
.
According to public information, CSPC is mainly engaged in the development, production and sales of pharmaceutical products
.
The company's products mainly include seven series of nearly 1,000 varieties, including cardiovascular and cerebrovascular, antibiotics, vitamins, antipyretic and analgesic, digestive system drugs, and anti-tumor drugs.
Among them, 30 products have sold over 100 million yuan per variety, and their products are sold all over the country.
and more than 100 countries around the world
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
The data show that roxadustat was discovered by Fibrogen, which is an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor
.
It can promote endogenous erythropoietin production, improve iron absorption and mobilization, and downregulate iron by inhibiting the ubiquitination degradation of hypoxia-inducible factor (HIF)
.
Roxadustat has been shown to maintain erythropoietin levels at or near the normal physiological range in multiple subgroups of patients with chronic kidney disease, thereby increasing red blood cell counts, without being affected by inflammatory states, and by avoiding intravenous iron supplementation
.
It is understood that Fibrex has cooperated extensively with major pharmaceutical companies to promote roxadustat
.
Among them, AstraZeneca is responsible for the development of the product in China, the United States, other markets in the Americas, Australia and New Zealand, and Southeast Asia
.
In December 2018, roxadustat entered the Chinese market through AstraZeneca and was approved for the treatment of anemia in patients with chronic kidney disease on dialysis.
Symptoms, and successfully entered the medical insurance catalog
.
The limited use of the 2021 version is for anemia caused by chronic kidney disease (CKD), including dialysis and non-dialysis patients
.
Thanks to the increase in medical insurance, roxadustat's domestic sales growth has accelerated in recent years
.
According to data from Minet.
com, in 2020, the product has exceeded 400 million yuan in terminals of public medical institutions in China, and the sales in the first half of 2021 will reach 500 million yuan, far exceeding the annual sales of the previous year.
Except in urban public hospitals, The market for this product in county-level public hospitals is also growing rapidly
.
According to data, in 2021, the sales of this product in the domestic market will exceed 1 billion yuan
.
AstraZeneca's financial report in 2021 shows that roxadustat's sales performance in 2021 will mainly come from the Chinese market, which will contribute US$174 million in revenue this year, in addition to a US$6 million cooperation share
.
It is worth mentioning that the original research drug is facing the challenge of patent expiration.
It is understood that the patent of roxadustat compound will partially expire in 2024, the patent of crystal form will expire in 2033, and the patent of preparation will also expire in 2034.
due
.
Relevant statistics show that, in addition to CSPC, there are four other companies including Chia Tai Tianqing, Jiangsu Wanbang, Jiangxi Shanxiang Pharmaceutical, and Chengdu Beite that have initiated BE trials of roxadustat generic drugs
.
Among them, Chia Tai Tianqing registered to start the BE trial as early as March 2020
.
In 2021, three companies, Jiangsu Wanbang, Shanxiang Pharmaceutical, and Chengdu Beite, will also start BE trials one after another
.
Judging from the clinical trial status, Chia Tai Tianqing, Jiangsu Wanbang, and Jiangxi Shanxiang Pharmaceutical have completed BE trials, while Chengdu Bite is still in progress
.
It is foreseeable that with the approval of these generic drugs, AstraZeneca's products will be impacted, and the market structure is expected to change
.
According to public information, CSPC is mainly engaged in the development, production and sales of pharmaceutical products
.
The company's products mainly include seven series of nearly 1,000 varieties, including cardiovascular and cerebrovascular, antibiotics, vitamins, antipyretic and analgesic, digestive system drugs, and anti-tumor drugs.
Among them, 30 products have sold over 100 million yuan per variety, and their products are sold all over the country.
and more than 100 countries around the world
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
