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    Home > Active Ingredient News > Infection > After 12 years, Mengke Pharmaceutical announced that Contizolamide Tablets, a new anti-drug-resistant bacteria drug, was approved for marketing

    After 12 years, Mengke Pharmaceutical announced that Contizolamide Tablets, a new anti-drug-resistant bacteria drug, was approved for marketing

    • Last Update: 2021-06-11
    • Source: Internet
    • Author: User
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    On June 2, Shanghai Mengke Pharmaceutical Co.
    , Ltd.
    announced that the National Medical Products Administration (NMPA) has approved its new drug listing application for the global original innovative drug Contizolamide Tablets (Uxitai) for drug-resistant bacterial infections.
    , The drug will be used to treat complicated skin and soft tissue infections.

    Contizolamide is a new generation of oxazolidinone antibacterial drug independently designed by the Chinese-American R&D team of Mengke Pharmaceutical, a Chinese company, after 12 years of development.
    It is a major breakthrough in domestically produced innovative drugs in the field of infectious diseases.

    The global demand for drugs for the treatment of drug-resistant bacteria has experienced a "starvation period" for nearly 30 years.
    In order to cope with the resistance of bacteria and solve the unmet clinical needs, we have developed effective and safe "super antimicrobials" that specifically fight drug-resistant bacteria.
    It has become an urgent strategic need for China.

    According to reports, through a lot of exploration and screening work, Mengke Pharmaceuticals discovered in 2008 a new generation of oxazolidinone drug candidates with independent intellectual property rights (code name MRX-I), intended to be used in the treatment of leather Infections caused by blue-positive bacteria (including multi-drug resistant bacteria).

    After twelve years of unremitting efforts, a large amount of data has confirmed that Contizolamide can effectively treat infections caused by drug-resistant Gram-positive bacteria, and at the same time significantly reduce the toxic and side effects related to myelosuppression of this type of antibacterial drug and the trend of inducing resistance.

    So far, Contizolamide has completed nine clinical trials at home and abroad.
    The approval in China this time is based on a multi-center randomized double-blind double simulation III for complex skin and soft tissue infections involving 719 patients.
    Efficacy and safety data obtained in phased clinical trials.

    Contizolamide was approved in China as the world's first release, and its advent opened a new journey of original innovative drugs in the field of anti-infection in China.

    At present, Contizolamide has successfully completed the Phase II clinical trial for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in the United States, and obtained the Qualified Anti-infective Product (QIDP) and Fast Review (Fast) granted by the US FDA.
    Track) identified. Mengke Pharmaceutical is about to launch an international multi-center phase III clinical trial to support the approval of Contizolamide in other countries and/or regions such as Europe and the United States.

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