Ruike Biologics Announces the Latest Progress of Phase III Clinical Development of Recombinant Nine-valent HPV Vaccine

Jiangsu Recco Biotechnology Co.

The phase III clinical trial of REC603 in China consists of three parts: the main efficacy trial, the immune bridging trial in small age groups, and the immunogenicity comparison trial with Gardasil? For 16,050 cases:

Main efficacy trial: In healthy women aged 18-45 years, evaluating the protective efficacy of high-grade cervical, vulvar, and vaginal high-grade intraepithelial neoplasia and above lesions associated with high-risk HPV infection contained in the experimental vaccine is the primary efficacy endpoint.

Small age group immune bridging trial: evaluating the non-inferiority of serum neutralizing antibodies in healthy women aged 9-17 years compared with healthy women aged 18-45 at 1 month after full-scale vaccination with the experimental vaccine

Immunogenicity Comparison Trial with Gardasil® 9: To evaluate the non-inferiority of serum neutralizing antibodies compared with Gardasil® 9 at 1 month after full vaccination with the test vaccine in healthy women aged 16-26 years

The nine-valent HPV vaccine can prevent approximately 90% of cervical cancers and 90% of anal and genital warts, and is widely regarded as the most effective vaccine against HPV