Wantai Bio launches phase III trial for male HPV vaccine

Beijing Wantai Biological Pharmacy Enterprise (SSE:603392) has announced the commencement of its Phase III clinical trial for its nine-valent Human Papillomavirus (HPV) vaccine (Escherichia coli) in men. The trial aims to evaluate the efficacy, immunogenicity, and safety of the vaccine in a cohort of 18 to 45-year-old Chinese men. This follows the approval from the National Medical Products Administration (NMPA) received in November 2024. The company notes that the vaccine targets HPV types 6/11/16/18/31/33/45/52/58, relevant in preventing genital warts and cancers. While the trial progresses, Wantai Bio acknowledges the uncertainties associated with achieving pre-set endpoints, securing NMPA approval, and the competitive landscape, including the existing quadrivalent HPV vaccine by Merck already approved for males in China.