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[Pharmaceutical Network Market Analysis] On August 4, Yuekang Pharmaceutical issued an announcement saying that the company recently received the "Approval Notice for Supplementary Drug Application" for azithromycin for injection (5g) approved and issued by the State Food and Drug Administrati.
Generic drug quality and efficacy consistency evaluati.
Azithromycin is a macrolide antibiot.
The antibacterial spectrum and antibacterial activity of these drugs are basically similar, and they have good antibacterial effects on most Gram-positive bacteria, Legionella, Chlamydia, Mycoplasma, and anaerobic bacter.
Its mechanism of action is to combine with the 50S subunit of bacterial ribosome to inhibit bacterial protein synthesis; its pharmacodynamics and pharmacokinetic properties are improved compared with those used, and adverse reactions are reduced; The in vitro antibacterial effect of bacteria and Neisseria gonorrhoeae is 2 to 8 times that of erythromycin, and the effect on Mycoplasma and Chlamydia is also enhanced; the stability in gastric acid is increased, the bioavailability is high, and the blood concentration and tissue concentration are increas.
The drug concentration is increased, the elimination half-life is prolonged, the daily dose and frequency of administration are reduced, the adverse reactions such as gastrointestinal reactions and liver toxicity are also significantly reduced, and the clinical indications are expanded, which is suitable for the treatment of community-acquired respiratory tract infectio.
dru.
According to data from Min.
com, the annual sales of azithromycin for injection in sample hospitals in China (urban public) in 2021 will be 453 million yu.
At present, in addition to Yuekang Pharmaceutical, a number of domestic companies have approved their products for listing, including Culuwa Pharmaceuticals, Asia Pacific Pharmaceuticals, Hainan Puli Pharmaceuticals, CSPC Ouyi Pharmaceuticals and other companies that have approved (or deemed approved) ) consistency evaluati.
According to the data, Yuekang Pharmaceutical is a large-scale pharmaceutical enterprise group dominated by high-end chemical dru.
Driven by R&D and innovation, it integrates the entire industrial chain of R&D, production and sales of chemical raw materials, high-end chemical drugs and biological dru.
Regarding this review, Yuekang Pharmaceutical stated that the drug review is a reflection of the company's comprehensive strength in R&D, production and quality management syste.
It is conducive to expanding the market share of the company's products and enhancing market competitivene.
At the same time, it has accumulated rich experience for the company's follow-up consistency evaluation product research, and further improved the company's overall research and development level and research and development capabiliti.
Yuekang Pharmaceutical has a strong level of R&D investme.
In 2021, the company's R&D expenses will be 261 million yuan, a year-on-year increase of 64
In the first quarter of 2022, R&D investment continued to increase, with a total investment of 108 million yuan, a year-on-year increase of 199
Under the continuous research and development, the company has made remarkable achievements in innovati.
The 1 class new drug Adenafil Citrate Tablets was successfully launched and commercialized, becoming the first nafil innovative drug approved in Chi.
At the same time, the company has built 8 core R&D platforms, covering nucleic acid medicine, traditional Chinese medicine and chemical medicine and other fiel.
It has reserved more than a dozen key pipelines, and has the dual advantages of technology accumulation and pipeline layo.
By the end of 2021, Yuekang Pharmaceutical has obtained a total of 157 patents, and will apply for 54 new patents in 2021, including 29 invention patents; in 2022, it will obtain the core patent in the field of nucleic acid drug delivery-LNP delivery system "a cationic lipid compound, Compositions and Uses Containing I.
At the same time, the company's performance also maintained a steady growth tre.
In 2021, the operating income will be 966 billion yuan, a year-on-year increase of 145%; the non-returnable net profit will be 510 million yuan, a year-on-year increase of 31
The operating performance in the first quarter of 2022 will continue the steady growth trend in 2021, achieving an overall operating income of 900 million yuan, a year-on-year increase of 4
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
Generic drug quality and efficacy consistency evaluati.
Azithromycin is a macrolide antibiot.
The antibacterial spectrum and antibacterial activity of these drugs are basically similar, and they have good antibacterial effects on most Gram-positive bacteria, Legionella, Chlamydia, Mycoplasma, and anaerobic bacter.
Its mechanism of action is to combine with the 50S subunit of bacterial ribosome to inhibit bacterial protein synthesis; its pharmacodynamics and pharmacokinetic properties are improved compared with those used, and adverse reactions are reduced; The in vitro antibacterial effect of bacteria and Neisseria gonorrhoeae is 2 to 8 times that of erythromycin, and the effect on Mycoplasma and Chlamydia is also enhanced; the stability in gastric acid is increased, the bioavailability is high, and the blood concentration and tissue concentration are increas.
The drug concentration is increased, the elimination half-life is prolonged, the daily dose and frequency of administration are reduced, the adverse reactions such as gastrointestinal reactions and liver toxicity are also significantly reduced, and the clinical indications are expanded, which is suitable for the treatment of community-acquired respiratory tract infectio.
dru.
According to data from Min.
com, the annual sales of azithromycin for injection in sample hospitals in China (urban public) in 2021 will be 453 million yu.
At present, in addition to Yuekang Pharmaceutical, a number of domestic companies have approved their products for listing, including Culuwa Pharmaceuticals, Asia Pacific Pharmaceuticals, Hainan Puli Pharmaceuticals, CSPC Ouyi Pharmaceuticals and other companies that have approved (or deemed approved) ) consistency evaluati.
According to the data, Yuekang Pharmaceutical is a large-scale pharmaceutical enterprise group dominated by high-end chemical dru.
Driven by R&D and innovation, it integrates the entire industrial chain of R&D, production and sales of chemical raw materials, high-end chemical drugs and biological dru.
Regarding this review, Yuekang Pharmaceutical stated that the drug review is a reflection of the company's comprehensive strength in R&D, production and quality management syste.
It is conducive to expanding the market share of the company's products and enhancing market competitivene.
At the same time, it has accumulated rich experience for the company's follow-up consistency evaluation product research, and further improved the company's overall research and development level and research and development capabiliti.
Yuekang Pharmaceutical has a strong level of R&D investme.
In 2021, the company's R&D expenses will be 261 million yuan, a year-on-year increase of 64
In the first quarter of 2022, R&D investment continued to increase, with a total investment of 108 million yuan, a year-on-year increase of 199
Under the continuous research and development, the company has made remarkable achievements in innovati.
The 1 class new drug Adenafil Citrate Tablets was successfully launched and commercialized, becoming the first nafil innovative drug approved in Chi.
At the same time, the company has built 8 core R&D platforms, covering nucleic acid medicine, traditional Chinese medicine and chemical medicine and other fiel.
It has reserved more than a dozen key pipelines, and has the dual advantages of technology accumulation and pipeline layo.
By the end of 2021, Yuekang Pharmaceutical has obtained a total of 157 patents, and will apply for 54 new patents in 2021, including 29 invention patents; in 2022, it will obtain the core patent in the field of nucleic acid drug delivery-LNP delivery system "a cationic lipid compound, Compositions and Uses Containing I.
At the same time, the company's performance also maintained a steady growth tre.
In 2021, the operating income will be 966 billion yuan, a year-on-year increase of 145%; the non-returnable net profit will be 510 million yuan, a year-on-year increase of 31
The operating performance in the first quarter of 2022 will continue the steady growth trend in 2021, achieving an overall operating income of 900 million yuan, a year-on-year increase of 4
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
