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Recently, the listing application (acceptance number: CYHS1700258) of Chia Tai Tianqing's 3 generic drug "polymyxin E sodium methanesulfonate for injection" changed its status in NMPA to "under approval", and the indication was adult hospital-acquired pneumonia.
.
CP Tianqing will become the first domestic imitation enterprise of polymyxin E sodium methanesulfonate
From NMPA official website
Since penicillin was used in clinics in 1940, antibacterial drugs have become the only therapeutic drugs for humans to fight against a variety of bacterial infections.
However, with the widespread use of antibacterial drugs in clinical practice, bacterial resistance to antibacterial drugs has become increasingly serious
.
The monitoring data of bacterial resistance at home and abroad have shown that multi-drug resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), extended-spectrum β-lactamase, and Klebsiella pneumoniae carbapenemase The detection rate of enterobacteria, multi-drug resistant Acinetobacter baumannii and Pseudomonas aeruginosa is increasing year by year, and multi-drug resistant bacteria infection has become one of the main causes of death in severely infected patients
Polymyxins are polypeptide antibiotics.
They were widely used in Gram-negative bacterial infections in the 1960s, but they were abandoned due to their potential nephrotoxicity, neurotoxicity and other adverse reactions
.
In recent years, with the emergence of a large number of multi-drug-resistant pathogens in hospital infections, polymyxins, as an old drug, are once again used in the clinical treatment of multi-drug-resistant and widely-drug-resistant Gram-negative bacteria infections
Polymyxin E sodium methanesulfonate is a peptide antibiotic.
It is currently the first 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 antibiotics or antibacterial drugs will not produce cross-resistance, and they are super antibiotics urgently needed by domestic patients with acute and severe illness
.
The original research drug of polymyxin E sodium methanesulfonate was first developed by Par Sterile Products.
The English name is Colistimethate Sodium for Injection and the trade name is Coly-Mycin M.
It is a classic old drug from the 1970s
.
However, the original research drug has not yet entered the country
According to the Insight database, currently, only Chia Tai Tianqing/Runzhong Pharmaceuticals and Jiangsu Osaikang have submitted listing applications in accordance with Class 3 generic drugs
.
Among them, the marketing application of polymyxin E sodium methanesulfonate for injection submitted by Chia Tai Tianqing/Runzhong Pharmaceutical was accepted by CDE in December 2017, and was subsequently included in the priority review procedure on the grounds of major special projects
Image source: Insight database
CP Tianqing’s colistin sodium methanesulfonate for injection was developed in conjunction with the Shanghai Pharmaceutical Industry Research Institute.
It submitted a listing application in 2014, but later withdrew the application during the self-examination of clinical trial data
.
In view of the strong antibacterial activity against drug-resistant bacteria, the increasing resistance to drugs such as hydrocarbons, and the global spread of the new crown epidemic, polymyxin E sodium methanesulfonate was approved for marketing and will become Chia Tai Tianqing A new growth point for future profits
.
The approval of polymyxin E sodium methanesulfonate will further establish the position of the first imitation king of CP Tianqing
