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    Home > Medical News > Latest Medical News > Teva thyphain benzene in China to submit new drug application

    Teva thyphain benzene in China to submit new drug application

    • Last Update: 2020-05-31
    • Source: Internet
    • Author: User
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    On December 27, CDE's official website showed that the FDA-approved first radon-for-the-drug, thorium-for-benin, had filed an NDA application in Chinadeuterlebenedeubonuclene (teva), the upper hydrogen (H) atom of Tetrabenazine (-OCH3) is replaced by its isotope thorium (-OCD3), approved by the U.SFDA on April 3, 2017 for the treatment of Huntington's disease (-OCD3), the first FDA approval for the treatment of Huntington's disease.)according to the first batch of clinically urgent lying new drugs released by CDE on November 1, 2018, which includes thorium-butylbenzene and butylbenzene, thorium-butylbenzene-inxandenopathy for late-onset motor disorder, Huntington's dance disease, butylnidine indications only Huntington's diseaseAt present, butylbenzene has not yet applied for listing in China, according to the national attention to rare diseases, in order to the current speed of the review of rare disease drugs, thorium benzene should soon land in the Chinese marketthe advantages of the development of thorium-on-drugwhy is it that the structure is almost identical to the butyl benzene or approved by the FDA in the case of the existing butyl benzene? The main reason is that the anti-thorium drug has the following advantages relative to its niobium-based drug:1, the anti-thorium drug is slow to decompose, stay longer in the body, the frequency of medication is reduced;At present, the development of niobium drugs is mainly the anti-drug generation of existing drugs, the main reasons for this trend of development are two: (1) the effectiveness and safety of existing drugs have been verified, hydrogen-based (H) atoms of radon (D) generation of the whole molecule has little impact, will not affect the effective binding effect of drug molecules and their binding sites, to maximize the retention of its effectiveness and Safety, and even the product of the later generation is better than its prototype drugs; (2) due to the lack of awareness of the drug niobium generation, resulting in many drug-based radon derivatives are not protected by patents, there is no patent protection of the trouble, for many enterprises, the research and development risk of this type of anti-drug drug is much smaller than the new skeleton structure of innovative drug research and developmentthe progress of research and development of foreign drugs
    including thorium-for-benin, there are now about 20 foreign drugs into the clinical development stage, the following will be on the clinical progress of these drugs to make an introductionTeva's thorium drugthorium-fortanion was first developed by Auspex PharmaceuticalsAuspex, an industry-renowned company focused on the development of radon and rare disease drugs, was acquired by Teva in 2015, giving It ownership of a range of thorium-based drugs developed by Auspex, including thorium-for-beninHuntington's disease, delayed motor disorder synod, pentobarbital has been approved by the U.S FDA At present, there are other indications in the clinical stage, including primary dystonia insufficiency (phase I/II), motor disorder cerebral palsy (phase III) and twitch-fouling syndrome (phase III) In addition, Teva also has the L-doba's radon derivative SD-1077, the Venlathein thorium derivative SD-254 and the niobium derivative SD-560 of niproquinone in the clinical phase I stage Concert develops xenon drugs
    Concert Pharmaceuticals, another foreign company focused on the development of the drug, has developed a number of radon-based drugs and has worked extensively with a number of other pharmaceutical companies its development of THE CTP-656 was acquired by Vertex Pharmaceuticals in 2017, CTP-656 is a derivative of Ivafettor's thorium, its indications are cystic fibrosis, and are currently in the clinical stage ii in addition , Concert has entered into an agreement with Avanir Pharmaceuticals to develop CTP-786, with Jazz Pharmaceuticals to develop JZP-386, with Processa Pharmaceuticals to develop CTP-499, and with Celgene Corporation to develop CTP-730 CTP-786 is a derivative of the thorium of right meschafin, and the current lynostic saccharine is developed for schizophrenia (phase II/III), bipolar disorder in Alzheimer's patients (phase III), NeuroinhibitDin (phase II) and refractory depression (phase II) JZP-386 is a radon derivative of sodium hydroxybutyrate, which has been clinically studied in Phase I of narcolepsy CTP-499 is a stage II clinical study of type 2 diabetes nephropathy, which is a derivative of thorium in the 1-(S) -5-hydroxylxyl-3-7-dimethylxanthi-ne (HDX) phase II CTP-730 is a derivative of Apremilast's radon generation and is currently only in the clinical stage of Phase I other drugs such as CTP-518, CTP-543, CTP-692, CTP-347 and CTP-354 are unique to Concert CTP-518 is a derivative of Azanavir's radon and is currently only completed in Phase I studies of healthy subjects CTP-543 is ruxolitinib's radon derivative, a JAK1/2 inhibitor whose indications are in the clinical state of Phase II CTP-692 is a derivative of D-serine, whose schizophrenia indications are in the clinical stage of Phase II CTP-347 is a radon derivative of paroxetine, which has been clinically phase I CTP-354 is a radon derivative of L-838417, which has been completed in Phase I clinical BMS-986165
    BMS-986165 is a new structure of the thorium drug developed independently by BMS, a selectty tyrosine kinase 2 (Tyk2) inhibitor At present, the research on psoriasis has entered the clinical stage of Phase III, and the indications for systemic lupus erythematosus, ulcerative colitis, granuloma colitis, lupus nephritis and psoriasis arthritis are in the clinical stage ii other representative radon drugs
    VX-984 is also a new structure of the xenon drug, developed by Vertex Pharmaceuticals in conjunction with Merck, a DNA-PK inhibitor that has completed phase I clinical studies for advanced solid tumors RT001 was developed by Retrotope, a thoradeant derivative that reduces the process of lipid peroxidation There are currently indications for Friedrich's co-employment disorder entering Phase III clinical, which is a rare genetic neurodegenerative disease associated with increased lipid peroxidation, accompanied by reflex disorders, sound disorders and sensory defects Based on the results of the study, the European Medicines Agency's Committee on Orphan Medical Products awarded RT001 orphan medicine certification for the treatment of infant-type neurosis malnutrition, which is in phase II/III, and based on the results of the study ALK-001, developed by Alkeus Pharmaceuticals, is a derivative of vitamin A," and currently has an indication of youth macular degeneration entering Phase II clinical, and an age-related macular degeneration (AMD) secondary map-like atrophy (GA) indication is in Phase III clinical studies GA is a late-stage form of AMD, characterized by the external retinal atrophy lesions, which in turn lead to the prosandance of visual function and irreversible loss of treatment, there is currently no approved treatment for GA, ALK-001 on GA clinical trialist is expected to be completed in 2022, it is expected to become the first approved treatment of GA In addition, Alkeus is preparing to test ALK001 in other eye diseases, including moderate dry AMD, pigmentation recessive retinal pigmentation, and autosomal recessive conical block-like malnutrition more than the development of foreign radon drugs in recent years, through the analysis of the above-mentioned drug structure found that the current research and development of the anti-thorium generation drugs is mainly concentrated on the existing drug radon generation, the new structure of the drug research is less However, whether it is the old drug's radon generation or the new structure of the drug research and development, have shown the advantages of introducing radon (D) into the drug molecule, drug niobium as a mature drug research and development ideas, will bring new possibilities for the drug effectiveness and safety improvement reference source: 1, CDE official website: http://
    2, the official website of the major companies
    3, ClinicalTrials.gov original title: NDA Teva thyphin benzene application for China NDA foreign radon drug research and development dynamics
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