First xenon drug Austedo approved for china

NMPA official website approval statusNovember 2018, the tablets of thoradebenzene tablets were included in the list of clinically urgent overseas new drugs (first batch), and then submitted the listing application directly in accordance with the "Clinically urgent overseas new drug review and approval procedures", and on December 27, 2019 by CDE, in March 2020, the listing application was included in the priority review procedureIt took just over four months from the time the application was submitted and the formal approval was grantedit is worth noting that the approval of the Antitan ® became the first chinese to approve the drug, and China became the second country in the world to approve the drug after the United StatesAntitan ® was approved by the U.SFDA in April 2017 (a product name Austedo ®), the first FDA-approved product and the second drug in the history of Huntington's disease-related dance diseaseApproved indications in the United States include dance disease associated with Huntington's disease (HD) and delayed motor disorder (TD) in adultsHuntington's disease is a rare and fatal neurodegenerative disease"Dance symptoms" are the most obvious symptoms of Huntington's disease, with nearly 90 percent of Huntington's patients experiencing convulsions and involuntary movements in the upper and lower limbs, faces or bodies during the illnessdelayed motor disorder (TD) is a debilitating motor disorder characterized by repetitive and uncontrollable movements in the tongue, lips, face, body, and limbsThe prevalence of TD in Chinese schizophrenia patients who have been treated with antipsychotic drugs for a long time is 33.7%, possibly caused by certain drugs used to treat mental health conditions, meaning that one-third of people with schizophrenia who use these drugs may have TDThe disease not only affects patients' therapeutic compliance, but also affects their quality of life and their social functionThere is currently no obvious effective treatment for TD in Chinaan anti-Titan ® approved for Huntington's disease-related dance disease was based on the results of a randomized, double-blind, placebo-controlled, multicenter trial involving 90 patients with dance disease with significant Huntington's diseaseThe study's main clinical evaluation indicators rated dance disease symptoms with the highest overall score (Total Maximal Chorea Score, TMC score)The results show that Antitan ®:has significant therapeutic effects The average TMC score improvement was 4.4 (placebo group 1.9, P 0.0001) in the thorium-deprex group and 33% (2% in the placebo group) According to the Unified Huntington Disease Rating Scale, UHDRS, the average improvement in the thorium-to-benin-benzoquine group was 7.4 (placebo group 3.4, P-0.002) can significantly improve treatment success rates According to the Patient's Overall Impression Change Scale (Patient Global Impression of Change, PGIC), the trial success rate of the thorium-deprecandain group was 51% (20% in the placebo group, P-0.002); have good security The incidence of neuropsychiatric events was lower in patients who started treatment Antitan ® approved for TD was based on the results of two phase III randomized, double-blind, placebo-controlled, parallel group studies The results of the study prove that Antitan ®: have significant therapeutic effects Abnormal involuntary movement levels (Abnormal Involuntary Movement Scale, AIMS) improved by 3.3 (placebo group 1.5, P 0.001 AIMS) in the 12th week of treatment with a 33% increase in the proportion of patients with a score of more than 50% (12% in the placebo group, P.0.007) can significantly improve treatment success rates In a comprehensive analysis of the ARM-TD and AIM-TD studies, patients who were treated with thoradepenbenzene were more than twice as likely to succeed at week 12 as those who used a placebo (2.1; P-0.005) and had an average CGIC score (48%) higher than placebo (30%) good safety and tolerance There was no negative effect on the measurement of drowsiness, weight, or heart metabolism thyfobutebenzene is a human cystic monoamine transport protein 2 (VMAT2) inhibitor, originally developed by Auspex Pharma, which was acquired by Teva in March 2015 for $3.5 billion Since its launch, the drug has been a stable product for Teva sales, with annual sales of $412 million, up more than 100 percent, in 2019 at present, Teva is also developing the treatment of thoradebutananin for primary dystonia dysplasia (phase I/II), motor-disorder cerebral palsy (phase III) and convulsive profanity syndrome (phase III) However, the drug's indications expansion is not plain sailing, in February this year, Tyva Pharmaceuticals announced that the treatment of moderate to severe lysing of children with 2/3 clinical ARTISTS 1 and 3 clinical ARTISTS 2 trials failed to reach the main endpoint Related read: Teva Austedo's treatment of convulsion syndrome fails in two clinical studies! in fact, VMAT2 inhibitors are not the Teva family that have suffered in the treatment of the convulsion syndrome As early as 2018, Neurocrine Biosciences abandoned its VMAT2 inhibitor class drug INGREZZA (valbenazine, phenyl-benzin) for the development of the disease after three failed clinical trials INGREZZA is the first new drug to receive FDA approval for delayed motor disorders However, even if the results of the clinical trial of the stoic syndrome are disappointing, the sales of thynophaph satout are still expected to reach the $650 million forecast by 2020, the best in the company's product line is an isotope of hydrogen, replacing it with thorium, may close the metabolic site, prolong the half-life of the drug, without affecting pharmacological activity, there are a number of domestic and foreign companies in the field of niobium drugs, such as BMS, Concert, Aclaris Therapeutics, Alkeus, PharmaDeeRx, Euclises, Vertex, as well as the domestic Zee Bio, Chengdu Haicheng Pharmaceuticals, Homo sac, etc.