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▎The content team editor of WuXi AppTec recently, an antibacterial drug for drug-resistant infections-Contizolamide tablets (trade name: UxiTai®), was approved for marketing by the National Medical Products Administration (NMPA) of China.
Treatment of complex skin and soft tissue infections caused by Staphylococcus aureus (methicillin sensitive and resistant strains), Streptococcus pyogenes or Streptococcus agalactiae that are sensitive to contizolid.
Screenshot source: NMPA official website.
At present, the global multidrug resistance (MDR) gram-positive bacteria is becoming more and more serious, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococcus (VRE) and methicillin-resistant Coagulase-negative staphylococci (MRCNS), etc.
, looking for effective treatments for multi-drug-resistant gram-positive bacteria is an urgent clinical need to fight infections today.
Among them, methicillin-resistant Staphylococcus aureus is one of the most common multi-drug resistant human bacterial pathogens in the world.
There are millions of people infected each year worldwide, which can cause various infections such as skin, bones, lungs, and blood.
And caused tens of thousands of deaths.
At present, some antibacterial drugs used to treat methicillin-resistant Staphylococcus aureus infections have played a certain therapeutic effect, but oral drugs for serious infections are rare.
From intravenous injection to oral treatment, patients need newer oral antibacterial drugs that are safer and more convenient.
Picture source: 123RF Contizolamide is a new generation of oxazolidinone oral antibacterial drugs used to treat drug-resistant bacterial infections, such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus infections.
According to public information, Contizolamide can inhibit the growth of bacteria by inhibiting the formation of the functional 70S initiation complex necessary for the process of bacterial protein synthesis, and effectively treat infections caused by drug-resistant gram-positive bacteria.
; At the same time reduce the myelosuppression-related toxic and side effects, blood adverse reactions and the tendency to induce drug resistance caused by such antibacterial drugs.So far, Contizolamide has completed nine clinical trials around the world.
The approval in China this time is based on the efficacy and safety data obtained in a Phase 3 clinical trial for complex skin and soft tissue infections.
The trial included a total of 719 subjects.
The results showed that the clinical cure rate of contizolamide during the cure test period (TOC, 7-14 days after the last dose) was similar to that of the control drug linezolid, but the drug There are fewer adverse events related to hematology.
The clinical cure rate of contizolamide (93.
0%) is comparable to that of the control drug (93.
4%); the overall incidence of adverse events (TEAE) after treatment is equivalent in the contizolamide group and the control group; judged by the investigator The adverse events related to the study drug were also similar, most of which were mild or moderate.
However, in the hematology examination, the incidence of adverse events related to the study drug was lower in the contizolamide group than in the control group.
Image source: 123RF's approval of Contizolamide tablets brings a new treatment plan for drug-resistant bacterial infections.
It is hoped that the approval of the new antibacterial drug will bring more treatment options to doctors and patients, and benefit patients with skin and soft tissue infections.
Recommended reading for the prevention and treatment of anaerobic infections.
New antibiotics are approved for marketing.
Innovative drugs suitable for general anesthesia have been approved in China, reducing the urgent clinical need for adverse events during anesthesia! The X-linked hypophosphatemia specific drug has been approved in China from drugless to preventable and controllable "chronic disease".
China's first NMOSD treatment drug has been approved.
Good news for Gaucher's patients! An Enzyme Replacement Therapy Approved in China Reference Materials [1] Mengke Pharmaceuticals announced that Contizolamide Tablets (Uxitai®), a new anti-drug-resistant bacteria drug, has been approved for marketing.
Retrieved Jun 3, 2021, from http:// The National Food and Drug Administration approved the marketing of Contizolamide tablets.
Retrieved Jun 3 ,2021,from https:// Note: This article aims to introduce the progress of medical and health research, not to recommend treatment options. If you need guidance on treatment plans, please go to a regular hospital for treatment.
Treatment of complex skin and soft tissue infections caused by Staphylococcus aureus (methicillin sensitive and resistant strains), Streptococcus pyogenes or Streptococcus agalactiae that are sensitive to contizolid.
Screenshot source: NMPA official website.
At present, the global multidrug resistance (MDR) gram-positive bacteria is becoming more and more serious, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococcus (VRE) and methicillin-resistant Coagulase-negative staphylococci (MRCNS), etc.
, looking for effective treatments for multi-drug-resistant gram-positive bacteria is an urgent clinical need to fight infections today.
Among them, methicillin-resistant Staphylococcus aureus is one of the most common multi-drug resistant human bacterial pathogens in the world.
There are millions of people infected each year worldwide, which can cause various infections such as skin, bones, lungs, and blood.
And caused tens of thousands of deaths.
At present, some antibacterial drugs used to treat methicillin-resistant Staphylococcus aureus infections have played a certain therapeutic effect, but oral drugs for serious infections are rare.
From intravenous injection to oral treatment, patients need newer oral antibacterial drugs that are safer and more convenient.
Picture source: 123RF Contizolamide is a new generation of oxazolidinone oral antibacterial drugs used to treat drug-resistant bacterial infections, such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus infections.
According to public information, Contizolamide can inhibit the growth of bacteria by inhibiting the formation of the functional 70S initiation complex necessary for the process of bacterial protein synthesis, and effectively treat infections caused by drug-resistant gram-positive bacteria.
; At the same time reduce the myelosuppression-related toxic and side effects, blood adverse reactions and the tendency to induce drug resistance caused by such antibacterial drugs.So far, Contizolamide has completed nine clinical trials around the world.
The approval in China this time is based on the efficacy and safety data obtained in a Phase 3 clinical trial for complex skin and soft tissue infections.
The trial included a total of 719 subjects.
The results showed that the clinical cure rate of contizolamide during the cure test period (TOC, 7-14 days after the last dose) was similar to that of the control drug linezolid, but the drug There are fewer adverse events related to hematology.
The clinical cure rate of contizolamide (93.
0%) is comparable to that of the control drug (93.
4%); the overall incidence of adverse events (TEAE) after treatment is equivalent in the contizolamide group and the control group; judged by the investigator The adverse events related to the study drug were also similar, most of which were mild or moderate.
However, in the hematology examination, the incidence of adverse events related to the study drug was lower in the contizolamide group than in the control group.
Image source: 123RF's approval of Contizolamide tablets brings a new treatment plan for drug-resistant bacterial infections.
It is hoped that the approval of the new antibacterial drug will bring more treatment options to doctors and patients, and benefit patients with skin and soft tissue infections.
Recommended reading for the prevention and treatment of anaerobic infections.
New antibiotics are approved for marketing.
Innovative drugs suitable for general anesthesia have been approved in China, reducing the urgent clinical need for adverse events during anesthesia! The X-linked hypophosphatemia specific drug has been approved in China from drugless to preventable and controllable "chronic disease".
China's first NMOSD treatment drug has been approved.
Good news for Gaucher's patients! An Enzyme Replacement Therapy Approved in China Reference Materials [1] Mengke Pharmaceuticals announced that Contizolamide Tablets (Uxitai®), a new anti-drug-resistant bacteria drug, has been approved for marketing.
Retrieved Jun 3, 2021, from http:// The National Food and Drug Administration approved the marketing of Contizolamide tablets.
Retrieved Jun 3 ,2021,from https:// Note: This article aims to introduce the progress of medical and health research, not to recommend treatment options. If you need guidance on treatment plans, please go to a regular hospital for treatment.
