Contrast agent, also known as contrast agent, is a product injected/taken into human tissues or organs to enhance the effect of image observation, and is an indispensable diagnostic and differential diagnosis drug
in medical imaging.
The data shows that the market demand for contrast agents is broad, of which the sales scale of terminal contrast agents in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) exceeded 17 billion yuan
in 2021.
It is reported that recently, there has been new news in the contrast agent market, such as China Resources Shuanghe issued an announcement that the octafluoropropane lipid microsphere injection declared by the company as a domestic agent has obtained the "Drug Registration Certificate" of the National Medical Products Administration; Hengrui Pharmaceutical issued an announcement that the company's application for gadolinium butrol injection (ANDA, that is, the US generic drug application) was approved by the US Food and Drug Administration (FDA).
.
.
According to the data, the octafluoropropane lipid microsphere injection of CR Shuanghe can provide heart chamber development, endocardial boundary improvement and local wall motion evaluation, and can also provide contrast in liver and kidney ultrasound and Doppler ultrasound evaluation of liver vascular structure, which is of great significance
for early detection and early prevention of cardiovascular and cerebrovascular diseases, liver diseases and kidney diseases.
According to Lansos' 2021 annual report, its octafluoropropane lipid microsphere injection product "DEFINITY"® had global sales of $233 million
in 2021.
Hengrui Pharmaceutical's gadolinium butrol injection is a paramagnetic contrast agent
for magnetic resonance imaging (MRI).
In March 2011 and July 2012, Bayer's gadolinium butrol injection (trade name: Gadavist) was approved in the United States and China respectively, accounting for nearly 10 years of the market
.
Data shows that in 2021, Bayer gadolinium butrol global sales were 418 million euros
.
In 2020, the sales of terminal gadolinium butrol in China's public medical institutions exceeded 50 million yuan
.
In March this year, Hengrui Pharmaceutical's gadolinium butrol injection was approved for marketing by the State Food and Drug Administration (NMPA), becoming the first imitation
in China.
Data show that since 2022, a total of 6 contrast agent products have been approved for marketing in China, of which the first generic drug accounts for 3, including Hengrui Pharmaceutical's gadolinium butrol injection, Kelun Pharmaceutical's gadolinol injection, and Beite Pharmaceutical's iopromide injection
.
It is reported that up to now, 11 varieties of contrast agents have passed or are deemed to have passed the consistency evaluation
.
Among them, Hengrui Pharmaceutical and Beilu Pharmaceutical have 5 varieties have been evaluated, Kelun Pharmaceutical and Sitaili each have 3 varieties have been evaluated, and Chia Tai Tianqing, Yangtze River Pharmaceutical and Nanjing Chia Tai Tianqing each have 2 varieties have been evaluated
.
The five varieties evaluated by Hengrui Pharmaceutical are iodixanol injection, gadolinium butrol injection, gadolinated glucosamine injection, opium poppy ethyl iodine oil injection, and iobuferol injection; The three varieties evaluated by Kelun Pharmaceutical were iopamol injection, gadolinated acid disodium injection, and gadolinol injection; The three varieties evaluated by Stephen are iodixanol injection, iopafen injection and iohexol injection
.
From the perspective of varieties, iodixanol injection has been evaluated by 6 enterprises, iopamol injection and iohexol injection have been evaluated by 4 and 3 enterprises respectively, and these three varieties have been included in the collective procurement
.
Gadolinium butrol injection, gadolinated acid glucosamine injection and gadolinium acid disodium injection have only been evaluated by 2 enterprises, and have not yet reached the conditions
for centralized procurement.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.
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