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On October 13, the official website of China National Food and Drug Administration (NMPA) announced that Chia Tai Tianqing, a subsidiary of China National Biopharmaceutical Corporation, had submitted its "polymyxin E sodium methanesulfonate for injection" listing application submitted under the registration category 3 category
.
Data from the NMPA official website shows that no similar product has been approved in China yet.
Screenshot source: NMPA official website
According to the notice of the generic drug reference preparation catalog (the 28th batch) issued by the NMPA, the original product of polymyxin E methanesulfonate for injection is Colomycin, which is held by Teva and has been in the European Union.
Listed
.
Currently, this product has not been approved in China
Public information shows that polymyxin is a group of cyclic peptide antibacterial drugs produced by Bacillus polymyxa.
It has at least ten different structures.
The current clinical applications include polymyxin B and polymyxin E.
.
They are all narrow-spectrum antibacterial drugs and have strong antibacterial activity against most aerobic gram-negative bacteria
Among them, polymyxin E mainly exerts antibacterial effects through the following two aspects: First, it destroys the structure of the outer cell membrane to increase its permeability, or causes the bacterial inner membrane to contact the outer membrane, causing the components of the inner and outer membranes to cross.
Lead to cell membrane instability, final osmotic pressure imbalance, cell swelling, outflow of contents, and cell death; second, polymyxin can induce reactive oxygen species, superoxide, hydrogen peroxide and hydroxyl free radicals in gram-negative bacteria Formation, causing oxidative stress in cells, damaging bacterial DNA, lipids and proteins, and ultimately leading to rapid cell death
.
In December 2017, CP Tianqing submitted an application for the marketing of colistin sodium methanesulfonate for injection in China
.
The application was subsequently included in the priority review program by the NMPA Center for Drug Evaluation (CDE) as a "major project".
Screenshot source: CDE official website
According to the “Chinese Multidisciplinary Expert Consensus on the Rational Clinical Application of Polymyxin Antibiotics" published in the Chinese Journal of Tuberculosis and Respiratory Medicine in April 2021, colistin antibacterial drugs came out in the late 1950s, and later due to safety Sexual problems gradually fade out of the clinic
.
In recent years, with the emergence and prevalence of carbapenem-resistant gram-negative bacteria infections, clinicians often fall into the predicament of no antibacterial drugs available, and polymyxin drugs have regained attention and returned to the clinic
Reference materials:
Reference materials:[1] On October 13, 2021, the drug approval document pending information is released.
[2] China Biopharmaceuticals: Voluntary Announcement.
[3] Announcement of the State Food and Drug Administration on Issuing the Catalogue of Generic Drug Reference Preparations (Twenty-Eighth Batch).
[4] Infectious Diseases Professional Committee of China Medical Education Association, Respiratory Medicine Branch of Chinese Medical Association, Critical Care Medicine Branch of Chinese Medical Association, etc.
(2021).
Multidisciplinary expert consensus on the rational clinical application of colistin antibiotics in China.
Chinese Journal of Tuberculosis and Respiration DOI: 10.
3760/cma.
j.
cn112147-20201109-01091.
