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Hengrui Medicine announced on the evening of March 27 that the company's gadobutrol injection was successfully approved
.
This product is a paramagnetic contrast agent for magnetic resonance imaging (MRI), which is used for contrast-enhanced magnetic resonance imaging (CE-MRI) examinations for the diagnosis of lesions in various parts of the body (including the brain and spinal cord); Contrast-enhanced magnetic resonance angiography (CE-MRA)
.
Contrast agent is one of the subsidiary industries in the field of medical imaging equipment, and it is a kind of drug often used in interventional radiology operations
.
In the process of differential diagnosis of diseases, it is sometimes difficult to pass conventional imaging examinations, and the contrast agent is injected into the human body to enhance the contrast of the images, so as to differentially diagnose tumors and some cardiovascular diseases
.
In recent years, as the Healthy China Initiative has entered a critical stage, vigorously promoting early cancer screening has become a consensus from all walks of life.
In this context, the market size of contrast agents has shown a continuous upward trend
.
In 2021, China's contrast agent market will see great growth.
The sales in the first three quarters have approached 15 billion yuan, a year-on-year increase of 71%
.
Among them, non-ionic organic iodine contrast agents are widely used due to their low osmotic pressure, good tolerance and stable performance, occupying half of the contrast agent market
.
Gadobutrol injection is a non-ionic contrast agent based on gadolinium.
After entering the Chinese market in July 2012, due to the difficulty of research and development and the high threshold, Galexian has been in a monopoly position in the Chinese market for ten years
.
Relevant data shows that the global sales of gadobutrol injection in 2020 will be about 307 million US dollars, and according to Minet data, Bayer’s Galexian sales revenue will be 418 million euros in 2021
.
Hengrui Medicine submitted a generic application for the product in category 6 generic drugs as early as November 2012.
It was included in the priority review in July 2016, and a round of supplementary information was carried out in April 2017.
The production site inspection was completed in April 2018.
, until the NMPA issued the drug approval in April 2020, and the approval conclusion was "not approved"
.
In May 2020, Hengrui Medicine once again submitted the product listing application
.
Subsequently, Beilu Pharmaceuticals, Yangzijiang Pharmaceuticals, and Kelun Pharmaceuticals also submitted applications for the product's listing
.
Up to now, in addition to the original research products, only Hengrui Medicine's "Gadobutrol" injection has been approved for production, which is deemed to have passed the quality and efficacy consistency evaluation of generic drugs, which means that Hengrui has become the first visit to this product.
+The first company to pass the review, and it also broke the market monopoly of the original researcher Bayer in China for many years, which will help to consolidate the company's position as the head company of contrast agents
.
Up to now, Hengrui Medicine's gadobutrol injection-related projects have invested about 27.
38 million yuan in research and development
.
It is understood that Hengrui Medicine has long been the No.
1 player in the domestic contrast agent market.
In 2020, the in-hospital sales of contrast agents has exceeded 4 billion yuan
.
In addition to the approved gadobutrol injection this time, Hengrui Medicine also has 4 contrast media products, iodixanol, ioversol, gadoteric acid meglumine, and poppy lipiodol injection.
Overrated
.
Among them, 4 products, including gadobutrol injection, are the first to be reviewed
.
In addition, the sales of iodixanol and ioversol have exceeded those of the original research products, and the sales in the hospital in 2020 will reach 2.
3 billion and 1.
5 billion respectively
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
This product is a paramagnetic contrast agent for magnetic resonance imaging (MRI), which is used for contrast-enhanced magnetic resonance imaging (CE-MRI) examinations for the diagnosis of lesions in various parts of the body (including the brain and spinal cord); Contrast-enhanced magnetic resonance angiography (CE-MRA)
.
Contrast agent is one of the subsidiary industries in the field of medical imaging equipment, and it is a kind of drug often used in interventional radiology operations
.
In the process of differential diagnosis of diseases, it is sometimes difficult to pass conventional imaging examinations, and the contrast agent is injected into the human body to enhance the contrast of the images, so as to differentially diagnose tumors and some cardiovascular diseases
.
In recent years, as the Healthy China Initiative has entered a critical stage, vigorously promoting early cancer screening has become a consensus from all walks of life.
In this context, the market size of contrast agents has shown a continuous upward trend
.
In 2021, China's contrast agent market will see great growth.
The sales in the first three quarters have approached 15 billion yuan, a year-on-year increase of 71%
.
Among them, non-ionic organic iodine contrast agents are widely used due to their low osmotic pressure, good tolerance and stable performance, occupying half of the contrast agent market
.
Gadobutrol injection is a non-ionic contrast agent based on gadolinium.
After entering the Chinese market in July 2012, due to the difficulty of research and development and the high threshold, Galexian has been in a monopoly position in the Chinese market for ten years
.
Relevant data shows that the global sales of gadobutrol injection in 2020 will be about 307 million US dollars, and according to Minet data, Bayer’s Galexian sales revenue will be 418 million euros in 2021
.
Hengrui Medicine submitted a generic application for the product in category 6 generic drugs as early as November 2012.
It was included in the priority review in July 2016, and a round of supplementary information was carried out in April 2017.
The production site inspection was completed in April 2018.
, until the NMPA issued the drug approval in April 2020, and the approval conclusion was "not approved"
.
In May 2020, Hengrui Medicine once again submitted the product listing application
.
Subsequently, Beilu Pharmaceuticals, Yangzijiang Pharmaceuticals, and Kelun Pharmaceuticals also submitted applications for the product's listing
.
Up to now, in addition to the original research products, only Hengrui Medicine's "Gadobutrol" injection has been approved for production, which is deemed to have passed the quality and efficacy consistency evaluation of generic drugs, which means that Hengrui has become the first visit to this product.
+The first company to pass the review, and it also broke the market monopoly of the original researcher Bayer in China for many years, which will help to consolidate the company's position as the head company of contrast agents
.
Up to now, Hengrui Medicine's gadobutrol injection-related projects have invested about 27.
38 million yuan in research and development
.
It is understood that Hengrui Medicine has long been the No.
1 player in the domestic contrast agent market.
In 2020, the in-hospital sales of contrast agents has exceeded 4 billion yuan
.
In addition to the approved gadobutrol injection this time, Hengrui Medicine also has 4 contrast media products, iodixanol, ioversol, gadoteric acid meglumine, and poppy lipiodol injection.
Overrated
.
Among them, 4 products, including gadobutrol injection, are the first to be reviewed
.
In addition, the sales of iodixanol and ioversol have exceeded those of the original research products, and the sales in the hospital in 2020 will reach 2.
3 billion and 1.
5 billion respectively
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
