On March 18 in Chicago, Handok Inc. and Genexine Co., Ltd. attended ENDO 2018, the 100^th and world’s largest endocrine society meeting, where they presented the results of a 6-month pediatric clinical phase-2 trial of the long-acting growth hormone GX-H9 currently undergoing joint development.

The 6-month data of ‘long-acting growth hormone GX-H9’ is from analysis of yearly growth rate of height, and while the control group of daily type growth hormone “Genotropin” showed the height growth rate of 11.24 cm/year, the group that administered 2.4mg/kg of “long-acting growth hormone GX-H9” twice a month showed the average annual growth rate of 11.86 cm/year. Also, the groups that administered 1.2 mg/kg and 0.8 mg/kg of “long-acting growth hormone GX-H9” once a week each showed a yearly growth rate of 11.54 cm/year and 11.50 cm/year accordingly. Based on these clinical results, the 6-month data of 1^st evaluation item showed similar results compared to the original one-a-day type, by which the administration convenience for patients is expected to be improved.

GX-H9 is a next-generation long-acting growth hormone drug applying the hybrid Fc (hyFc) approach, a generic technology of Genexin, and can be administered once a week or twice a month. Currently, GX-H9 is in preparation for phase-3 clinical trials of the USFDA this year, following phase-2 clinical trials in Europe and Korea. Global sales of the once-a-day type growth hormone is estimated at 4 trillion won as of 2017, and with the launch of once-a-week and twice-a-month type, the growth hormone market is expected to grow rapidly.

Meanwhile, Handok Inc. and Genexine Co., Ltd. signed a technology transfer and joint development contract in June 2012 for a sustainable growth hormone agent as strategic partners. Handok Inc. became the largest shareholder of Genexine in 2014. GX-H9 has been selected by the Korea Drug Development Fund as a support project due of its outstanding technology and was assigned as a rare drug by the United States Food and Drug Administration (FDA) in the fourth quarter of 2016.