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Follitropin alfa Fc fusion protein (UN008) is a long-acting recombinant human follicle-stimulating hormone (hFSH) Fc fusion protein developed by Guangzhou Unicohealth Biotechnology. The drug consists of a recombinant human FSH fused to a human IgG2 Fc variant (vIgG2Fc) via a peptide linker, structured with an hFSHβ subunit, CTP, an hFSHα subunit, a peptide linker, and the vIgG2Fc from N-terminal to C-terminal. By utilizing Unicohealth's proprietary γBloc Fc long-acting technology, the fusion protein achieves a significantly prolonged in vivo half-life (approximately 7 days) compared to conventional recombinant FSH, while avoiding potential ADCC/CDC side effects. It is designed to stimulate multifollicular development for assisted reproductive technology (ART) and controlled ovarian stimulation (COS) in women with female infertility and anovulation. The drug is currently in Phase I clinical development in China.
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