China has taken a significant step in the fight against cervical cancer by approving its first domestically developed nine-valent human papillomavirus (HPV) vaccine, Cecolin 9.
The National Medical Products Administration announced the approval on Wednesday, marking China as the second country globally, after the United States, to independently supply high-valency HPV vaccines. Cecolin 9 is a collaborative creation of the Xiang An Biomedicine Laboratory, Xiamen University, and Wantai BioPharm.
Since 2019, Cecolin 9 has undergone extensive clinical trials across the Chinese mainland, involving over 11,000 healthy volunteers aged between 9 and 45. The results have been promising, showing strong protection against HPV types 16 and 18—the strains covered by the two-valent vaccine—as well as five additional types: 31, 33, 45, 52, and 58. The vaccine demonstrated over 98% efficacy against persistent infections lasting more than 12 months and provided 100% protection against cervical infections.
A notable advantage of Cecolin 9 is its dosing regimen for younger girls. For those aged 9 to 17, just two doses are sufficient to elicit an immune response comparable to the three-dose schedule in women aged 18 to 26. This makes it the only two-dose HPV vaccine available for girls aged 15 to 17 in China.
A comparative study published in The Lancet Infectious Diseases revealed that Cecolin 9 offers immune responses on par with international counterparts for at least 30 months post-immunization. This advancement builds upon the success of the research team that developed China’s first domestically made two-valent HPV vaccine in 2019. That vaccine received pre-qualification from the World Health Organization (WHO) in 2021 and has since been introduced to markets in 21 countries.
Cervical cancer remains a significant health concern, ranking as the fourth most common cancer among women worldwide in 2022, according to the WHO. In response, China has intensified its efforts to combat the disease. The National Health Commission announced that by 2024, free HPV vaccinations will be accessible to approximately 40% of girls aged 13 to 14, underscoring the country’s commitment to public health initiatives.
The approval of Cecolin 9 represents a major milestone in expanding access to advanced HPV vaccines, potentially reducing the incidence of cervical cancer and improving health outcomes for women and girls across the nation.
