Phase III clinical trial of TransCon human growth hormone obtains NMPA approval
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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growth hormone deficiency (GHD) refers to growth retardation caused by growth hormone secretion dysfunction, which is a disease that seriously affects the physical and mental
health of children and adolescents
(http://, with a incidence rate of about 1/10000 to 1/1000recently, VISEN Pharmaceuticals announced that its TransCon human growth hormone to China's NationalDrug(http://Regulatory Authority (NMPA) submitted the Phase III ClinicalTrial(http://application has been approved, will soon be conducted in China to treat childhood growth hormone deficiency clinical researchTransCon human growth hormone will become China's first unmodified long-acting human growth hormone, which is used once a week to continuously release the same human growth hormone as the daily formulationrecently, TransCon human growth hormone was awarded by the European Commission to treat childhood growth hormone deficiency orphan drug certificationThere is currently no long-acting growth hormone available in the United States or EuropeTransCon human growth hormone is the only human growth hormone pre-drug in the world designed using the "Temporary Connection"patented (http:// technology TransCon's mechanism of action differs from other technologies for long-acting growth hormone analogues It ensures the release of unmodified, active human growth hormone in the human body for 7 days, ensuring that the tissue distribution of active human growth hormone in the body is consistent with the daily recombinant growth hormone (rhGH) , TransCon has completed key Phase III clinical studies (heiGHt studies) for children with growth hormone deficiency in Europe and the United States, with first-line data presented at the Annual EndOcrinology Conference (ENDO 2019) in March and the recent European Paediatric Endocrinology Conference in Vienna TransCon human growth hormone's annualized growth rate after 52 weeks of treatment was significantly better than the daily recombinant human growth hormone (two groups of differences of 0.86cm/year, p.0088) The results also demonstrate the difference between TransCon human growth hormone, which uses TransCon technology
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