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    Home > Medical News > Latest Medical News > In the first half of the year, the number of new drugs approved by the National Bureau reached a new high, and my country's innovative drugs entered the stage of full-scale outbreak

    In the first half of the year, the number of new drugs approved by the National Bureau reached a new high, and my country's innovative drugs entered the stage of full-scale outbreak

    • Last Update: 2021-08-04
    • Source: Internet
    • Author: User
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    With the opening of special review and approval channels such as "priority review", "fast track", "breakthrough therapy", and "conditional approval", the speed of review and approval of innovative drugs has been greatly improved


    Among the 36 new drugs approved for marketing in 2021, 22 are imported new drugs and 14 are domestic new drugs


    Furmonertinib

    On March 2, 2021, NMPA reviewed and conditionally approved the third representative skin growth factor receptor (EGFR) kinase inhibitor vomitinib (trade name: Ivesa) of Shanghai Ailisi Pharmaceutical.


    Telitacicept

    On March 9, 2021, NMPA prioritized review and conditionally approved Rongchang Biotech’s Taltazep (trade name: Tai'ai), combined with conventional treatment, suitable for activities with high disease activity on the basis of conventional treatment Adult patients with sexual, autoantibody-positive systemic lupus erythematosus (SLE)


    Utidelone

    On March 11, 2021, NMPA gave priority to Chengdu Huahao Zhongtian Pharmaceutical Co.


    Fospropofol (Fospropofol Disodium)

    On May 19, 2021, NMPA approved Renfu's short-acting intravenous general anesthetic, propofol


    Pamiparib

    On April 30, 2021, NMPA prioritized review and conditionally approved BeiGene's Pamipali (trade name: Baihuize) for use in previous second-line or above chemotherapy and susceptibility to germline breast cancer Treatment of patients with recurrent advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer with gene (gBRCA) mutations



    Contezolid

    On June 1, 2021, NMPA prioritized the review and approval of Shanghai Mengke Pharmaceutical's Contizolamide (trade name: Uxitai) for the treatment of Staphylococcus aureus (methicillin) sensitive to Contizolamide Sensitive and resistant strains), Streptococcus pyogenes or Streptococcus agalactiae caused complex skin and soft tissue infections


    Donafenib

    On June 8, 2021, the NMPA prioritized review and approved Suzhou Zejing Biopharmaceutical's Donafinil Tosylate (trade name: Zeprosyn) for use in unresectable liver cells that have not previously received systemic treatment.



    Disitamab Vedotin

    On June 8, 2021, NMPA prioritized review and conditional approval of Rongchang Biopharmaceutical's vedicitumumab (trade name: Aidixi) for the locally advanced HER2 overexpression that has received at least two systemic chemotherapy Or the treatment of patients with metastatic gastric cancer (including adenocarcinoma of the gastroesophageal junction)


    Savolitinib

    On June 22, 2021, the NMPA prioritized review and conditionally approved Hutchison Whampoa’s Saivotinib (trade name: Oresa/ORPATHYS) for use in disease progression or intolerance criteria after platinum-containing chemotherapy.


    Tenofovir Amibufenamide

    June 22, 2021, NMPA priority review approval Jiangsu Stockhausen Amy tenofovir (brand name: Hang Mu), for the treatment of adult patients with chronic hepatitis


    Hybutimibe

    On June 25, 2021, NMPA prioritized the review and approval of Zhejiang Hisun Pharmaceutical D Haibo Maibu (trade name: ), as an adjuvant treatment other than diet control, which can be used alone or in combination with HMG-CoA reductase inhibition Drugs (statins) are used in combination to treat primary (heterozygous familial or non-familial) hypercholesterolemia


    Ainuovirine

    On June 25, 2021, NMPA passed the priority review and approved Jiangsu Aidi Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor Ainovirin (trade name: Aibond) for use in combination with nucleoside antiretroviral drugs , Treatment of adult HIV-1 infection newly-treated patients


    Levornidazole Disodium

    On May 26, 2021, NMPA approved Yangtze River’s Levoornidazole Disodium, which is the prodrug of the nitroimidazole antibiotic Levoornidazole, which can be rapidly degraded into Levoornidazole Play a therapeutic role
    .
    Before this product was approved, Yangzijiang had completed three pharmacokinetics and one safety and effectiveness study
    .
    In the safety and effectiveness study (CTR20180384), a total of 147 people joined the clinical trial, which was completed in 2019, and detailed data has not been disclosed
    .

    In addition to the above 14 domestic new drugs, it is worth mentioning that NMPA also approved the first CAR-T akirenzine for the treatment of relapsed or refractory large B-cell lymphoma
    .
    Since Axicabtagene Ciloleucel is a cell therapy, which is different from traditional drugs, the author will not discuss it here
    .
    New domestic or imported drugs approved by my country in the first half of the year

    The above data is only based on the author's personal statistics.
    It contains chemical medicines and therapeutic biological products, but does not contain Chinese medicines, proteins, vaccines, blood products and cell products.
    The deadline is June 30

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