China’s Walvax Biotechnology Co., Ltd (SHE: 300142) announced the first subject enrollment for a Phase III clinical study assessing the immunogenicity of its in-house developed nine-valent human papillomavirus (HPV) vaccine compared with Merck Sharp & Dohme’s (MSD) Gardasil 9.
The vaccine is designed for the prevention of cervical cancer, vulvar cancer, vaginal cancer, and anal cancer caused by HPV infection types 16, 18, 31, 33, 45, 52, and 58, as well as genital warts caused by HPV types 6 and 11 in age-appropriate females. It is also intended to prevent anal cancer and genital warts in age-appropriate males caused by the same HPV types. The product, which initiated clinical studies in 2018, demonstrated a favorable safety and immunogenicity profile in Phase I trials.
Merck Sharp & Dohme is currently the only company marketing a nine-valent HPV vaccine globally, alongside its bivalent and quadrivalent HPV vaccines. The HPV vaccine market generated combined global sales of USD 6.3 billion in 2021.-Fineline Info & Tech
