China Grants Marketing Nod to Ferring Pharmaceuticals’ Rekovelle for Assisted Reproduction

Switzerland-based Ferring Pharmaceuticals Ltd announced that its recombinant human follicle stimulating hormone δ injection, Rekovelle, has been granted marketing approval in China. This product, a recombinant follicle stimulating hormone (rFSH) known as follitropin delta derived from human cell lines, has already received approvals across numerous countries and regions. It is utilized for controlled ovarian stimulation to induce the development of multiple follicles in women undergoing assisted reproductive technology treatments, such as in vitro fertilization or intracytoplasmic sperm injection.

Clinical data from the Asian population indicate that the sustained pregnancy rate for Rekovelle’s individualized dosing regimen is 31.3%, compared to 25.7% for the control group. The live birth rate in the Rekovelle group also reached 31.3%, which is notably higher than the control group’s rate of 24.7%. Furthermore, Rekovelle has demonstrated a significant reduction in the incidence of early ovarian hyperstimulation syndrome (OHSS), with a rate of 5.0% in the Rekovelle group, markedly lower than the 9.6% observed in the follicular hormone α group.- Flcube.com

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