QL1012

QL1012 is a biosimilar version of follitropin alfa, a recombinant human follicle-stimulating hormone (FSH). It's being developed by Qilu Pharmaceutical for the treatment of female infertility, specifically for ovarian stimulation in women undergoing assisted reproductive technology (ART). Clinical trials have demonstrated therapeutic equivalence and similar safety profiles between QL1012 and the reference product Gonal-f®[2][5].\n\nIn a phase III clinical trial conducted at 13 centers in China between October 2018 and June 2019, QL1012 showed comparable efficacy to Gonal-f® in terms of the number of oocytes retrieved during ovarian stimulation. The mean number of oocytes retrieved was 14.7 ± 7.0 in the QL1012 group compared to 13.4 ± 6.1 in the Gonal-f® group[2][5]. The safety profile was also similar, with comparable rates of ovarian hyperstimulation syndrome (12.4% versus 13.1%) and other adverse events[2].

Other names

recombinant human follicle-stimulating hormonerhFSH biosimilar