The application for a phase 3 registration test of Theitan Growth Hormone of Tianyi Organisms was accepted by the State Drug Administration.

Guide: Etan Growth Hormone Differentiation Long-Acting Recombinant Human-derived Growth Hormone Phase 3 Registered Clinical Trials, a weekly drug-administered approach to clinical treatment studies for children with childhood growth hormone deficiency.
Tianyi Bio announced today that China's State Drug Administration (NMPA) has accepted a phase 3 registration 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 recombinant human-derived growth hormone (rhGH) designed and developed using the patented technology of Genexine, a South Korean company, known as the innovative hybrid Fc Fusion Protein Technology Platform (hyFc®, with novel molecular form and longer half-life, administered only once a week.
Etan growth hormone stimulates the synthesis of insulin-like growth factor 1 (IGF-1) in the liver and stimulates the growth stimulation of a variety of tissues, including bone cells and cartilage cells, to promote bone growth. in addition,
, prior studies and trials have shown that etan growth hormone, as a natural protein product, can not only maintain the efficacy of short-acting growth hormone, but also may avoid the market common polyethylglycolgrowth hormone safety hazards.
this phase 3 registered clinical trial is a multi-centered, randomized, open-label, positive-controlled 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-deefficiencies compared to the positive control drug Noze ® recombinant human growth hormone injections.
the study program will recruit about 165 subjects. "The acceptance of this phase 3 registered clinical trial by the State Drug Administration is an important step in the company's plan to bring this innovative product to the Chinese market," said Dr. Shen Huaqiong, CEO of
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through this study, we hope that this highly differentiated product will provide a safer and more convenient treatment for children with growth hormone deficiency and further address urgent medical needs.
", Genexine has previously demonstrated good safety, tolerance and initial efficacy of etane growth hormone in three international multicenter clinical trials in Europe and Asia, including a phase I trial for healthy subjects, a 1b/2 multi-region trial for adult growth hormone deficiency (NCT029466606) and a phase II multi-region clinical trial for child growth hormone deficiency (NCT033098911).
Skylife acquired the rights to the development, production and commercialization of Etan growth hormone in China from Genexine.
About 3.4 million children with growth hormone deficiency in Greater China receive growth hormone treatment, mainly with daily injections, according to Frost and Sullivan.
recombinant human growth hormone injections are now included in China's national health insurance catalogue.
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