A recombinant human growth hormone fused to hyFc
Adult growth hormone deficiency (AGHD)
Pediatric growth hormone deficiency (PGHD)
Completed adult phase 2 clinical trial (2016), Designated by US FDA ODD (2016)
Completed pediatric phase 2 clinical trial (2019), Designated by EU EMA ODD (2021)
Pediatric phase 3 in China (on-going)
GX-H9 is one of the long-acting hGH products, which uses hyFc fusion protein technology to increase the half-life in the body, and it is administered once a week or twice-monthly. It is a biobetter product that significantly increases the convenience of administration for patients compared to the conventional short-acting hGH administered daily.
GX-H9 demonstrated safety and efficacy in both adults and pediatric patients in the previous clinical trials and is currently in phase 3 trial with PGHD patients in China.
A long-acting growth hormone preparation that combines a platform that has non-cytolytic properties because it uses a sequence that does not have the ability to induce cytotoxicity among the sites of IgG4 and IgD that exist in vivo and a human growth hormone secreted from the anterior pituitary
Growth hormone is an anterior pituitary protein that stimulates the hepatic production and release of insulin-like growth factor-1 (IGF-1) into the systemic circulation. IGF-1 is a potent hormone in promotion of growth for children and in the control of metabolism for adults.
GX-H9 has a unique potential to be a convenient long-term GH providing not only weekly but also twice-monthly treatment option, with comparable safety and efficacy profile to daily products.