Give the medicine once a week! The clinical application for phase 3 registration of Thein growth hormone of Tianyi organism was accepted.

On the evening of August 4, Tianyi Bio announced that The State Drug Administration of China (NMPA) had accepted a three-phase registered clinical trial application for its etanesomatropin (eftansomatropin, TJ101) differentiated long-acting recombinant human-derived growth hormone.
the trial to conduct clinical treatment studies on children with childhood growth hormone deficiency, a weekly drug administration.
Etan Growth Hormone is a long-acting recombinant human-derived growth hormone (rhGH) designed and developed using Genexine's innovative hybrid Fc Fusion Protein Technology Platform (hyFc®), with novel molecular forms and a longer half-life, administered only once a week. Earlier
, Tianyi acquired the rights to the development, production and commercialization of Etan Growth Hormone in China from Genexine.
Etan growth hormone stimulates the synthesis of insulin-like growth factor 1 (IGF-1) in the liver and stimulates growth stimulation of a variety of tissues, including bone cells and cartilage cells, to promote bone growth, according to the Skylife Biology news release.
pre-research and tests have proved that, as a natural protein product, etan growth hormone can not only maintain the effect of short-acting growth hormone, but also may avoid the market common polyglycolgine growth hormone safety risks.
previously, Genexine has demonstrated good safety, tolerance and initial efficacy of etane growth hormone in three international multicenter clinical trials in Europe and Asia, including a Phase 1 trial for healthy subjects, a Phase 1b/2 multi-regional trial for adult growth hormone deficiency (NCT02946606) and a phase 2 multi-region clinical trial for child growth hormone deficiency (NCT03098911).
about 3.4 million children with growth hormone deficiency in Greater China, but only 3.7 percent receive growth hormone therapy, mainly with daily injections, according to frost and Sullivan.
recombinant human growth hormone injections are now included in China's national health insurance catalogue.
is known that etan growth hormone, which is being developed by Tianyi Bio, is expected to become a safer, more convenient and effective alternative to growth hormone deficiency, as a highly differentiated long-acting recombinant human-derived growth hormone.
program,3 phase 3 registered clinical trials in China are a multicenter, randomized, open-label, positive-control clinical study designed to assess the safety, efficacy and pharmacokinetics of Etan growth hormone in the treatment of growth hormone deficiency in children, and to demonstrate non-essential effects compared to the positive control drug Nozer ® recombinant human growth hormone injections.
the study program will recruit about 165 subjects.
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