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On December 1, Huluwa Pharmaceuticals issued an announcement stating that the company had recently received the "Drug Supplementary Application Approval Notice" on "Azithromycin for Injection" approved and issued by the State Food and Drug Administration.
The drug passed the quality and efficacy consistency of generic drugs.
Evaluation
.
This also means that another over-rated pharmaceutical company has ushered in antibiotics with more than 700 million yuan! The announcement shows that azithromycin belongs to the macrolide antibiotics and has good antibacterial effects against most Gram-positive bacteria, Legionella, Chlamydia, Mycoplasma, and anaerobic bacteria
.
Azithromycin is a 15-membered ring macrolide, the first species of azalides; its mechanism of action is to bind to the 50S subunit of the bacterial ribosome to inhibit bacterial protein synthesis; its pharmacodynamic and pharmacokinetic properties Compared with the used varieties, the adverse reactions are reduced; the in vitro antibacterial effect on Haemophilus influenzae, Moraxella catarrhalis, and Neisseria gonorrhoeae is 2-8 times that of erythromycin, and the effect on Mycoplasma and Chlamydia It has also been enhanced; increased stability in gastric acid, high bioavailability, increased blood drug concentration and drug concentration in tissues, prolonged elimination half-life, reduced daily dosage and number of administrations, gastrointestinal reactions and liver toxicity, etc.
Adverse reactions have also been significantly reduced, and clinical indications have been expanded, making it a suitable drug for the treatment of community-acquired respiratory infections
.
It is understood that the consistency evaluation project of azithromycin for injection by Huluwa Pharmaceutical was established in 2019, and a supplementary application for the consistency evaluation of azithromycin for injection was submitted in December 2020.
It was accepted on January 4 this year and received a supplementary application for drugs recently.
Approval
.
It took nearly a year from acceptance to approval
.
From the perspective of the market structure, many domestic companies’ related products have been approved for listing.
In addition to Gourd Baby Pharmaceutical, Hainan Puli Pharmaceutical, CSPC Ouyi Pharmaceutical, and Jiangsu Wuzhong have passed (or viewed Same as passed) Consistency evaluation
.
Among them, in November, Jiangsu Wuzhong announced that the wholly-owned subsidiary also received the "Drug Supplementary Application Approval Notice" on "Azithromycin for Injection" approved and issued by the State Food and Drug Administration.
The drug passed the generic drug quality and efficacy consistency.
Evaluation
.
From the perspective of the market size of the product, according to data from Minai.
com, the overall market size of azithromycin injection in public medical institutions nationwide in 2020 is about 770 million yuan.
.
According to relevant national policies and regulations, appropriate support should be given to medical insurance payment for drug varieties that have passed the consistency evaluation of generic drugs, and medical institutions should give priority to procurement and give priority to clinical selection
.
If there are more than 3 manufacturers of the same type of drugs that have passed the consistency evaluation of generic drugs, the products that have not passed the consistency evaluation of generic drugs will no longer be selected in terms of centralized drug procurement
.
The company said that the product passed the generic drug consistency evaluation, which is conducive to enhancing the drug’s market competitiveness and has a positive impact on the drug’s market sales.
At the same time, it has accumulated valuable for the company’s follow-up product to carry out generic drug consistency evaluation work.
Experience
.
As of the date of this announcement, the company has invested approximately 4.
68 million yuan (unaudited) in the research and development of the drug
.
In recent years, with the advancement of antimicrobial grading management and other restrictive measures, China's antibiotic market has grown slowly.
In 2020, the market size of China's antibiotic industry will be about 178 billion yuan
.
However, with the acceleration of China's population aging process and the expansion of national medical insurance investment, the industry expects that the antibiotic industry as a whole will maintain a large demand in the next few years, and the market size is expected to be close to 1.
950 billion yuan by 2022
.
The drug passed the quality and efficacy consistency of generic drugs.
Evaluation
.
This also means that another over-rated pharmaceutical company has ushered in antibiotics with more than 700 million yuan! The announcement shows that azithromycin belongs to the macrolide antibiotics and has good antibacterial effects against most Gram-positive bacteria, Legionella, Chlamydia, Mycoplasma, and anaerobic bacteria
.
Azithromycin is a 15-membered ring macrolide, the first species of azalides; its mechanism of action is to bind to the 50S subunit of the bacterial ribosome to inhibit bacterial protein synthesis; its pharmacodynamic and pharmacokinetic properties Compared with the used varieties, the adverse reactions are reduced; the in vitro antibacterial effect on Haemophilus influenzae, Moraxella catarrhalis, and Neisseria gonorrhoeae is 2-8 times that of erythromycin, and the effect on Mycoplasma and Chlamydia It has also been enhanced; increased stability in gastric acid, high bioavailability, increased blood drug concentration and drug concentration in tissues, prolonged elimination half-life, reduced daily dosage and number of administrations, gastrointestinal reactions and liver toxicity, etc.
Adverse reactions have also been significantly reduced, and clinical indications have been expanded, making it a suitable drug for the treatment of community-acquired respiratory infections
.
It is understood that the consistency evaluation project of azithromycin for injection by Huluwa Pharmaceutical was established in 2019, and a supplementary application for the consistency evaluation of azithromycin for injection was submitted in December 2020.
It was accepted on January 4 this year and received a supplementary application for drugs recently.
Approval
.
It took nearly a year from acceptance to approval
.
From the perspective of the market structure, many domestic companies’ related products have been approved for listing.
In addition to Gourd Baby Pharmaceutical, Hainan Puli Pharmaceutical, CSPC Ouyi Pharmaceutical, and Jiangsu Wuzhong have passed (or viewed Same as passed) Consistency evaluation
.
Among them, in November, Jiangsu Wuzhong announced that the wholly-owned subsidiary also received the "Drug Supplementary Application Approval Notice" on "Azithromycin for Injection" approved and issued by the State Food and Drug Administration.
The drug passed the generic drug quality and efficacy consistency.
Evaluation
.
From the perspective of the market size of the product, according to data from Minai.
com, the overall market size of azithromycin injection in public medical institutions nationwide in 2020 is about 770 million yuan.
.
According to relevant national policies and regulations, appropriate support should be given to medical insurance payment for drug varieties that have passed the consistency evaluation of generic drugs, and medical institutions should give priority to procurement and give priority to clinical selection
.
If there are more than 3 manufacturers of the same type of drugs that have passed the consistency evaluation of generic drugs, the products that have not passed the consistency evaluation of generic drugs will no longer be selected in terms of centralized drug procurement
.
The company said that the product passed the generic drug consistency evaluation, which is conducive to enhancing the drug’s market competitiveness and has a positive impact on the drug’s market sales.
At the same time, it has accumulated valuable for the company’s follow-up product to carry out generic drug consistency evaluation work.
Experience
.
As of the date of this announcement, the company has invested approximately 4.
68 million yuan (unaudited) in the research and development of the drug
.
In recent years, with the advancement of antimicrobial grading management and other restrictive measures, China's antibiotic market has grown slowly.
In 2020, the market size of China's antibiotic industry will be about 178 billion yuan
.
However, with the acceleration of China's population aging process and the expansion of national medical insurance investment, the industry expects that the antibiotic industry as a whole will maintain a large demand in the next few years, and the market size is expected to be close to 1.
950 billion yuan by 2022
.
