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[Pharmaceutical Network Industry News] The progress of generic drug consistency evaluation has attracted much attention in the industry
.
According to incomplete statistics, in the last week (March 20, 2022-March 26, 2022), 23 new varieties (deemed as) have been reviewed, of which 5 are the first review, namely Hengrui's gadolinium Butol injection, Hisco's arginine and glutamate injection, Chia Tai Tianqing's methacholine for inhalation, Heyi Pharmaceutical's lidocaine hydrochloride ophthalmic gel, Chengji Pharmaceutical's cyproheptadine hydrochloride Oral solution
.
Among them, gadobutrol injection is a non-ionic contrast agent based on gadolinium, which is mainly used for magnetic resonance imaging examination of systemic lesions and whole-body magnetic resonance angiography examination
.
The original drug of this product is Bayer's Gallexian, which was approved for marketing in China in July 2012.
In 2021, Bayer's Gallexian sales revenue will be 418 million euros
.
This time, Hengrui successfully won the first imitation and is deemed to have passed the consistency evaluation, which will break the monopoly of the original drug in the market for ten years
.
Arginine and glutamate injection is a new generation of dual mechanism ammonia-lowering drugs, suitable for ammonia-lowering treatment of hepatic encephalopathy caused by various reasons
.
The drug has been included in the medical insurance.
According to Minet.
com, the terminal sales of arginine and glutamic acid injection in Chinese public medical institutions in 2019 have exceeded 100 million yuan
.
At present, only Haisco Pharmaceuticals sells arginine glutamic acid in China.
In 2019, the sales revenue of sample hospitals was 38.
64 million yuan, an increase of 11.
47% year-on-year
.
A few days ago, Haisco's first review of this variety will help further consolidate the company's dominant position in the field of liver and gallbladder adjuvant therapy drugs
.
Methacholine for inhalation is indicated for the methacholine challenge test for the diagnosis of bronchial airway hyperresponsiveness, in adult patients without clinically significant asthma symptoms and in well-cooperating pediatric patients 5 years of age and older
.
At present, the original research product of this variety has not been listed in China, and CP Tianqing has successfully won the first domestic imitation and the first home evaluation
.
Lidocaine is a local anesthetic and antiarrhythmic drug
.
The data shows that the sales revenue of lidocaine in public hospitals in key provinces and cities in China in 2021 will be 159 million yuan, a year-on-year increase of 37.
33%
.
There are many dosage forms of this variety, among which lidocaine hydrochloride ophthalmic gel is an innovative dosage form, which is mainly used for ophthalmic surgery and surface anesthesia for ophthalmic examinations
.
At present, only Sichuan Heyi Pharmaceutical has submitted a marketing application (new category 3), and has obtained the first copy, and the first home is deemed to have passed the consistency evaluation
.
Cyproheptadine hydrochloride oral solution is an anti-allergic drug, and Beijing Chengji Pharmaceutical successfully won the first copy of the drug this time
.
The data shows that the sales revenue of cyproheptadine in 2021 will be 280,000 yuan
.
Among them, Chongqing Kerui accounted for nearly 40% of the sales market, followed by Guangdong Huanan Pharmaceutical, Chenxin Pharmaceutical, Shanghai Xinyi and so on
.
It is worth mentioning that another pharmaceutical company has passed the consistency evaluation this week
.
On March 28, Harbin Sanlian Pharmaceutical announced that the company has recently received the approval notice for supplementary drug application approved and issued by the State Food and Drug Administration, and the company's product methylcobalamin injection has passed the quality and efficacy consistency evaluation of generic drugs
.
Methylcobalamin injection is mainly used for peripheral neuropathy
.
Treatment of macrocytic anemia due to vitamin B12 deficiency
.
This variety belongs to the national medical insurance category
B.
According to data from Minet.
com, the sales amount of methylcobalamin injection in China's public medical market in 2020 is 488 million yuan
.
Up to now, there are many manufacturers holding the production approval for this product, and 4 have passed the consistency evaluation
.
Among them, the methylcobalamin injection of Yangtze River is the first in the country to be reviewed
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
According to incomplete statistics, in the last week (March 20, 2022-March 26, 2022), 23 new varieties (deemed as) have been reviewed, of which 5 are the first review, namely Hengrui's gadolinium Butol injection, Hisco's arginine and glutamate injection, Chia Tai Tianqing's methacholine for inhalation, Heyi Pharmaceutical's lidocaine hydrochloride ophthalmic gel, Chengji Pharmaceutical's cyproheptadine hydrochloride Oral solution
.
Among them, gadobutrol injection is a non-ionic contrast agent based on gadolinium, which is mainly used for magnetic resonance imaging examination of systemic lesions and whole-body magnetic resonance angiography examination
.
The original drug of this product is Bayer's Gallexian, which was approved for marketing in China in July 2012.
In 2021, Bayer's Gallexian sales revenue will be 418 million euros
.
This time, Hengrui successfully won the first imitation and is deemed to have passed the consistency evaluation, which will break the monopoly of the original drug in the market for ten years
.
Arginine and glutamate injection is a new generation of dual mechanism ammonia-lowering drugs, suitable for ammonia-lowering treatment of hepatic encephalopathy caused by various reasons
.
The drug has been included in the medical insurance.
According to Minet.
com, the terminal sales of arginine and glutamic acid injection in Chinese public medical institutions in 2019 have exceeded 100 million yuan
.
At present, only Haisco Pharmaceuticals sells arginine glutamic acid in China.
In 2019, the sales revenue of sample hospitals was 38.
64 million yuan, an increase of 11.
47% year-on-year
.
A few days ago, Haisco's first review of this variety will help further consolidate the company's dominant position in the field of liver and gallbladder adjuvant therapy drugs
.
Methacholine for inhalation is indicated for the methacholine challenge test for the diagnosis of bronchial airway hyperresponsiveness, in adult patients without clinically significant asthma symptoms and in well-cooperating pediatric patients 5 years of age and older
.
At present, the original research product of this variety has not been listed in China, and CP Tianqing has successfully won the first domestic imitation and the first home evaluation
.
Lidocaine is a local anesthetic and antiarrhythmic drug
.
The data shows that the sales revenue of lidocaine in public hospitals in key provinces and cities in China in 2021 will be 159 million yuan, a year-on-year increase of 37.
33%
.
There are many dosage forms of this variety, among which lidocaine hydrochloride ophthalmic gel is an innovative dosage form, which is mainly used for ophthalmic surgery and surface anesthesia for ophthalmic examinations
.
At present, only Sichuan Heyi Pharmaceutical has submitted a marketing application (new category 3), and has obtained the first copy, and the first home is deemed to have passed the consistency evaluation
.
Cyproheptadine hydrochloride oral solution is an anti-allergic drug, and Beijing Chengji Pharmaceutical successfully won the first copy of the drug this time
.
The data shows that the sales revenue of cyproheptadine in 2021 will be 280,000 yuan
.
Among them, Chongqing Kerui accounted for nearly 40% of the sales market, followed by Guangdong Huanan Pharmaceutical, Chenxin Pharmaceutical, Shanghai Xinyi and so on
.
It is worth mentioning that another pharmaceutical company has passed the consistency evaluation this week
.
On March 28, Harbin Sanlian Pharmaceutical announced that the company has recently received the approval notice for supplementary drug application approved and issued by the State Food and Drug Administration, and the company's product methylcobalamin injection has passed the quality and efficacy consistency evaluation of generic drugs
.
Methylcobalamin injection is mainly used for peripheral neuropathy
.
Treatment of macrocytic anemia due to vitamin B12 deficiency
.
This variety belongs to the national medical insurance category
B.
According to data from Minet.
com, the sales amount of methylcobalamin injection in China's public medical market in 2020 is 488 million yuan
.
Up to now, there are many manufacturers holding the production approval for this product, and 4 have passed the consistency evaluation
.
Among them, the methylcobalamin injection of Yangtze River is the first in the country to be reviewed
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
