CSPC PHARMA (01093): Bivalent human papillomavirus mRNA therapeutic vaccine (SYS6026) approved for clinical trial.

CSPC PHARMA (01093) announced that the therapeutic bivalent messenger RNA (mRNA) vaccine SYS6026, developed by the group for the treatment of precancerous lesions caused by human papillomavirus (HPV) types 16 or 18, has been approved by the China National Medical Products Administration for clinical trials in China. This product is the group's first therapeutic vaccine developed independently based on the mRNA platform, composed of mRNA molecules combined with lipid nanoparticle (LNP) delivery system. The product induces a specific T cell immune response by expressing the E6 and E7 antigens of HPV types 16 or 18, thereby clearing cells infected with HPV and blocking the process of carcinogenesis. Current clinical treatment methods mainly rely on surgery, which carries the drawbacks of causing significant harm to patients and being prone to recurrence. As a highly effective non-surgical treatment option, this product is expected to meet significant clinical needs in the field and has a high clinical development value. As of now, there is no therapeutic HPV vaccine on the market globally. The approved clinical indication for this product is the treatment of high-grade squamous intraepithelial lesions (HSIL) related to HPV types 16 or 18.