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    Home > Medical News > Latest Medical News > Teva-dybutanine is approved immediately.

    Teva-dybutanine is approved immediately.

    • Last Update: 2020-08-01
    • Source: Internet
    • Author: User
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    On April 30, Teva's application for the listing of the xenon-butyl benzoine tablets (receiving the status of JXHS1900175, 176, 177, 178, 179, 180) was changed to "in approval", which means that the first drug in the country will soon be approved.
    deutetrabenazine is a class of cystic monoamine transporter 2 (VMAT2) inhibitors.
    VMAT2 (vesicle monoamine transporter 2) is a protein concentrated in the human brain and is primarily responsible for repackaging and transporting monoamine molecules (dopamine, norepinephrine, serotonin and histamines) in the pre-combined neurons.
    the drug was originally developed by Auspex Pharmaceuticals and later acquired by Teva.
    April 2017, the FDA approved the drug for the treatment of Huntington's disease, the product called Austedo ™, became the first FDA-approved drug to be marketed, and was subsequently approved by the FDA to treat late-onsic motor disorder.
    compared to Tetrabenazine (Tetrabenazine, Xenazine), a pyridine (-OCD3) genus that replaces two methoxygenate (-OCH3) atoms with the isotope thysium (D).
    changes in this structure make it metabolize more slowly than butyl phenyna, and its efficacy and safety are improved than butyl phenyna.
    since its launch, sales of thoratopentine have grown rapidly, with global sales of $204 million and $412 million in 2018 and 2019, respectively.
    believe that with the development of new adaptations, such as primary dystonia (Phase I/II), motor-impaired cerebral palsy (Phase III), and pumping-naratinsyndrome (Phase III), sales of pyridoxine will reach a new level.
    unfortunately, in February this year, Teva announced that the primary endpoint was not reached in clinical stage 2/3 ARTISTS 1 and clinical stage 3 ARTISTS 2 in the treatment of children with moderate to severe convulsive language syndrome.
    in China, the drug-based benzodiazepine was included in the First Clinically Urgently Needed Overseas New Drugs List in November 2018, and the indications are late-onset movement disorders and Huntington's disease.
    December 2019, the listing application for buprenorphine was accepted by CDE and included in the priority review in March 2020.
    it is worth mentioning that the application for listing is submitted directly in accordance with the Procedure for the Review and Approval of Clinically Urgent overseas New Drugs.
    in accordance with the procedures for the review and approval of overseas drug treatments for rare diseases, the technical review shall be completed within 3 months after acceptance, and the technical review shall be completed within 6 months after acceptance of other new drugs abroad.
    the author expected that may be due to the cause of the new crown outbreak, the drug after acceptance of more than 4 months to complete the technical review, the drug is expected to be officially approved in china.
    Huntington's disease is a rare autosomal dominant genetic disease, which is characterized by abnormalities in motor cognition and mental function.
    and delayed movement disorder is a central nervous system disease characterized by repetitive rhythmic movements of the face, torso, or limbs, including mouth,ghost, tongue, facial movement, wink, and mouth.
    part of the characteristics of both diseases are dopamine, which regulates the concentration of dopamine in neurons in these diseases, which can be beneficial to patients.
    currently very limited number of drugs approved to treat these two diseases, in addition to butpeninine and thypline, the FDA has approved TheIngrezza of Neurocrine Biosciences for the treatment of late-onsis movement disorders in adults.
    Ingrezza is also a selective VMAT2 inhibitor, later approved than pyridothin, but it is safer, without a black-frame warning of predobenzin depression and suicidal thoughts (the first indications approved for both drugs are different).
    at home, these two diseases have not yet been approved for sale, the urgent need for effective treatment drugs.
    is a hydrogen isotope present in nature, after replacing hydrogen with thorium, it may close the metabolic site, prolonging the half-life of the drug without affecting pharmacological activity (small differences in the shape of H and D).
    in addition to pyridoxine, Teva is also developing the zoobio-dopa's progenitor derivative SD-1077, Venrafasine derivative SD-254 and pyridine derivative SD-560, which are currently in the clinical phase. in addition to teva,
    , there are a number of domestic and foreign companies that have a presence in the pharmaceutical sector, such as BMS, Concert Pharma, Aclaris Therapeutics, Alkeus Pharma, DeuteRx, Euclises, Vertex and others.
    in the country, Zeyan Bio, Chengdu Haicheng Pharmaceuticals, Tongyuan Kang, Zhengda Tianqing and other enterprises are also developing the drug, in which Zexau bio's methicatol Donafini, is Bayer's first solafeni of the niobium, was developed for the treatment of a variety of tumors, the current treatment of advanced / metastatic thyroid cancer and colon clinical trials in stage III, according to the company's official website, Zee Bio has submitted the application for the drug.
    , The Jacktinib of Zetini (the jak inhibitor Momelotinib of Gilead) and Okatinib (the eGFR T790M inhibitor of AstraZeneca, the prototype drug is AstraZeneca) are also xenon substitutes, where Jacktinib is in the clinical stage of treatment for baldness, bone marrow fibrosis II, and Okatinib is in the clinical stage of treatment for late-stage NSCLC and ALK.c. hc-1119, the first compound of
    Haitron Pharmaceuticals, is a new androgen receptor (AR) antagonist, a product of encarnomine, and is currently undergoing a global multi-center Phase III clinical trial for mCRPC patients.
    References: s1. NMPA official website , 2 , Zeyu biological, Chengdu Haicheng official website.
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