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Recently, Chia Tai Tianqing’s application for the listing of three generic drugs of Polymyxin E Methanesulfonate for Injection has been approved by the National Medical Products Administration.
This is the first approved Polymyxin E Methanesulfonate for Injection in China.
It is mainly used to treat infections that are diagnosed or highly suspected of being caused by sensitive bacteria
.
The product was jointly developed by CP Tianqing and Shanghai Pharmaceutical Industry Research Institute
.
The approved indications for polymyxin E sodium methanesulfonate are mainly acute or chronic infections caused by sensitive strains of Gram-negative bacilli, especially those caused by sensitive strains of Pseudomonas aeruginosa
.
It is clinically effective for infections caused by Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.
In order to reduce the production of drug-resistant bacteria and maintain the effectiveness of this product and other antibacterial properties, Sodium polymyxin E methanesulfonate should only be used to treat infections that are diagnosed or highly suspected of being caused by sensitive bacteria
.
Due to the abuse of antibiotics, the problem of bacterial resistance has become a major difficulty in clinical antibacterial treatment.
Polymyxin has excellent efficacy in treating multidrug resistance and was once known as the star variety in drug-resistant peptides
.
Polymyxin E sodium methanesulfonate is a peptide antibiotic.
It is currently the drug of choice for the treatment of infections caused by multi-drug-resistant Pseudomonas aeruginosa and other gram-negative bacteria.
The drug resistance rate is low (less than 5%), and it is compatible with Other types of antibiotics or antibacterial drugs will not produce cross-resistance, and they are super antibiotics urgently needed by domestic patients with acute and severe illness
.
In addition, polymyxin E sodium methanesulfonate has also been awarded the "Adult Hospital Acquired Pneumonia and Ventilator-Associated Pneumonia Clinical Practice Guidelines" of the American Association of Infectious Diseases, the European Society of Surgical Infections "Guidelines for the Management of Abdominal Infections", and the Chinese Medical Association.
The unanimous recommendation of "Guidelines for Clinical Application of Antibiotics in Patients with Neutrophil Deficiency and Fever"
.
The raw material of polymyxin E sodium methanesulfonate is independently developed by Chia Tai Tianqing.
It has obtained the CEP (European Pharmacopoeia Applicability Certification) certificate issued by the European Medicines Quality Administration, and has been sold to European countries
.
CP Tianqing Polymyxin E Methanesulfonate was supported by the national major scientific and technological project of "Major New Drug Development" in 2015, and submitted a domestic marketing application in December 2017.
The application was approved by the Drug Evaluation Center of the State Food and Drug Administration Included in the priority review process, it will benefit more patients after it is marketed
.
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