Shiyao Group (01093): Phase II clinical trial of SYS 6026 injection for the treatment of high-grade cervical squamous intraepithelial lesions associated with HPV16 or type 18 was officially launched in China

Zhitong Finance App News, Shiyao Group (01093) announced that the phase II clinical trial of the SYS 6026 injection (this product) developed by the Group to treat high-grade cervical squamous intraepithelial lesion (HSIL) related to human papillomavirus (HPV) type 16 or 18 has been officially launched in China.

This product is a therapeutic m RNA vaccine. The registered category is therapeutic biological product class 1, and its action targets HPV16 and 18 subtypes E6 and E7 protein antigens. The product is delivered to cells through lipid nanoparticles (LNP), and then translated and expressed E6 and E7 proteins within the cell, and then presented on the cell surface by human leukocyte antigen (HLA) molecules, which induce the body to produce E6 and E7 specific T cells and kill HPV-infected cells or tumor cells that express target antigen genes.

HPV16 and type 18 are the most pathogenic HPV subtypes currently known. About 10% of women infected with HPV type 16 or 18 will develop high-grade precancerous cervical disease within 3 years after infection, and more than 70% of high-grade cervical lesions and cervical cancer are related to HPV type 16 or 18. As a new non-surgical treatment option, this product is expected to provide new treatment options for HPV16 or type 18 related HSIL.

Previously, the Group had received a clinical trial approval notice issued by the State Drug Administration of the People's Republic of China in November 2024, and subsequently initiated phase I clinical trials to evaluate the safety and tolerability of this product in HPV 16 or 18 related HSIL patients. The Phase II clinical trial initiated this time is a multi-center, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of this product compared to placebo treatment for HPV 16 or 18 related HSIL participants. Currently, the recruitment and selection of project participants is being actively promoted.