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    Home > Active Ingredient News > Drugs Articles > After 12 years, the new oxazolidinone antibacterial drug was finally approved

    After 12 years, the new oxazolidinone antibacterial drug was finally approved

    • Last Update: 2021-06-30
    • Source: Internet
    • Author: User
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    On June 2, the official website of the National Medical Products Administration (NMPA) of China announced that Shanghai Mengke Pharmaceutical Co.
    , Ltd.
    (hereinafter referred to as Mengke Pharmaceutical) declared a category 1 innovative drug , Contizolamide Tablets (trade name: Youxitai).
    ) The listing has been approved through the priority review and approval procedures
    .

    Source: NMPA official website

    The drug is an innovative drug independently designed by the Sino-US R&D team of the Chinese company Mengke Pharmaceutical and has independent intellectual property rights.
    It is used to treat Staphylococcus aureus (methicillin-sensitive and drug-resistant strains) sensitive to contizolamide , Complicated skin and soft tissue infections caused by Streptococcus pyogenes or Streptococcus agalactiae
    .

    Contazolamide is Mengke Pharmaceutical's first new generation of oxazolidinone original innovative drug that has been independently developed and approved for marketing.
    The new generation of oxazolidinone antibacterial drug obtained after 12 years of development is a domestic innovation in the field of infectious diseases.
    A major breakthrough in medicine
    .

    Contazolamide's first clinical trial application in China was approved in 2010.
    In 2019, the drug under investigation completed China's first phase 3 clinical trial
    .
    In 2018, it also obtained Fast Track status granted by the FDA in the United States to treat acute bacterial skin and skin tissue infections


    .


    From the beginning of clinical research to the official approval in 2021, the development of this new antibacterial drug has gone through 12 years
    .

    Contizolamide's unique mechanism of action

    Oxazolidinone antibacterial drugs have a unique mechanism of action that is different from ordinary antibacterial drugs.
    They mainly interfere with protein synthesis by inhibiting the formation of bacterial ribosomal 50S subunits, 30S subunits, mRNA and fMet-tRNA complexes
    .
    However, due to adverse reactions and other circumstances, it still cannot fully meet the clinical treatment needs of gram-positive drug-resistant bacteria such as MRSA


    .


    Contazolamide adds meta-fluorine to the benzene ring in the molecular structure and increases the'non-coplanar' design of ortho-fluorine, which greatly reduces the side effects and drug interactions of oxazolidinone antibacterial drugs; at the same time, dihydro The structure of the pyridine ring and isoxazole enhances the binding to the bacterial target, which makes the drug more active and more difficult to develop drug resistance
    .

    Clinical efficacy

    The results of a pivotal Phase III clinical study for the treatment of complex skin and soft tissue infections (cSSTI) conducted in 47 clinical institutions in China showed that contazolamide was in the primary endpoint of the cure test period (TOC, 7- after the last administration).
    14 days) clinical cure rate, non-inferior to linezolid, and showed lower drug-related hematological adverse events
    .
    This trial was carried out in 50 clinical centers in China.


    Among the enrolled 719 patients, there were 589 clinically evaluable patients


    The results of the study showed that the clinical cure rate of conzolid (93.
    0%) was equivalent to that of linezolid (93.
    4%)
    .
    The overall incidence of adverse events (TEAEs) after treatment was similar in the two groups of contazolamide and linezolid.


    TEAEs determined by the investigator to be related to the study drug were also similar, and most of them were mild or moderate


           Thus, Conde temozolomide is required to use narcotic analgesics, uncontrolled hypertension, patients with central nervous system disorders, diabetes medication safer choice
    .

           Mengke R&D pipeline

    Mengke R&D pipeline (photo source: Mengke official website)

           In addition to Contezolid tablets, Mengke Pharmaceutical's other drug under development, Contezolid phosphate (MRX-4, contezolid acefosamil), is a prodrug of Contezolid, and is being developed globally in both oral and injectable dosage forms
    .
    Mengke Pharmaceutical also has products under development such as the new polymyxin drug MRX-8 for MDR gram-negative bacteria, and the new drug MRX-12 for MDR gram-negative bacteria


    .


           At present, the widespread use of various antibiotics will inevitably bring about the increasingly serious problem of bacterial resistance, and the emergence of multi-drug resistant bacteria poses a severe challenge to the public health systems of all countries in the world
    .
    In 2017, the VitalSigns report of the U.


    S.


           Oxazolidinone antibacterial drugs are a kind of antibacterial drugs with a new structure, with a unique mechanism of action and good antibacterial activity, and are considered to be a new direction to solve the multi-drug resistance of Gram-positive bacteria
    .
    Today, when bacterial resistance is developing at an alarming rate, the successful launch of a new generation of oxazolidinone antibiotics is gratifying for the entire society and patients


    .


           Reference source :

           1.


           2.


           3.
    https://       4.
    The official website of Mengke Pharmaceutical
    .

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