South Korean pharmaceutical company Handok announced Friday that GX-H9, a long-acting recombinant human growth hormone it co-developed with Genexine, has won orphan drug designation from the country's Ministry of Food and Drug Safety.
Handok said the designation for GX-H9, which it received on Monday this week, will help the company speed up the launch of the medicine.
In Korea, when a drug qualifies for the orphan drug designation, the drug is eligible for conditional approval based on results from phase 2 clinical studies.
Handok has currently completed its phase 2 clinical studies of GX-H9, but when the company will launch the drug has not yet been decided, according to an official from Handok.
“Handok will decide on the drug’s launch after seeing results from phase 3 clinical studies that its Chinese partner I-Mab Biopharma is conducting in China,” the official added.
I-Mab Biopharma, which has the sales rights of GX-H9 in China, is expected to apply for marketing authorization during this year based on the results.
GX-H9 is a next-generation growth hormone, using antibody-fusion technology (hyFc). Unlike conventional human growth hormones, which require daily administration, GX-H9, a long-acting recombinant HGH, only needs to be administered once a week or every two weeks.
GX-H9 received orphan drug designations from the US Food and Drug Administration in 2016 and the European Medicines Agency in 2021.
