CSPC Pharmaceutical Group Limited (CSPC Pharma) reported that its therapeutic mRNA candidate SYS6026 has entered Phase II evaluation in China for the treatment of human papillomavirus (HPV) type 16- or 18-related cervical high-grade squamous intraepithelial lesion (HSIL). The announcement was released on 22 July 2026.

SYS6026 is classified as a Class 1 therapeutic biological product. Encapsulated in lipid nanoparticles, the mRNA encodes the E6 and E7 antigens of HPV16 and HPV18. After intracellular translation, these antigens are presented on the cell surface via human leukocyte antigen molecules, triggering E6- and E7-specific T-cell responses aimed at eliminating HPV-infected or tumour cells.

HPV16 and HPV18 represent the most pathogenic HPV subtypes. Approximately 10% of women infected with either subtype develop high-grade cervical precancerous lesions within three years, and over 70% of high-grade cervical lesions and cervical cancers are associated with these strains.

The newly initiated Phase II study is multicentre, randomised, double-blind and placebo-controlled, designed to assess the efficacy and safety of SYS6026 versus placebo in patients with HPV16- or HPV18-related HSIL. Participant recruitment and screening have commenced.

The programme follows the National Medical Products Administration’s approval to begin clinical trials in November 2024 and a completed Phase I trial focused on safety and tolerability. As a non-surgical therapeutic candidate, SYS6026 could offer an alternative treatment pathway for patients with HPV16/18-related HSIL, subject to positive clinical outcomes.