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KM04 is a biosimilar candidate of follitropin alfa, a recombinant human follicle-stimulating hormone (r-hFSH). Developed by Xentria Inc. under an exclusive licensing agreement with K-Bio, KM04 is intended for the treatment of female infertility. The drug acts as an agonist of the follicle-stimulating hormone receptor (FSHR), mimicking the physiological role of endogenous FSH in stimulating the recruitment and development of multiple ovarian follicles. This mechanism is essential for controlled ovarian stimulation in patients undergoing assisted reproductive technologies (ART), such as in vitro fertilization (IVF), and for the induction of ovulation in women with certain types of infertility who have not responded to other treatments.
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