China Approves First Domestically Produced Nine-Valent HPV Vaccine
Cecolin 9, developed jointly by Xiamen University and Wantai BioPharm, enhances China's capabilities in HPV prevention.
On May 30, China announced the approval of Cecolin 9, its first domestically developed nine-valent human papillomavirus (HPV) vaccine, as sanctioned by the National Medical Products Administration.
This significant development positions China as the second country globally, following the United States, to independently offer high-valency HPV vaccines.
Cecolin 9 was developed through a collaborative effort involving the Xiang An Biomedicine Laboratory, Xiamen University, and Wantai BioPharm.
The approval comes after extensive clinical trials conducted since 2019, which included over 11,000 healthy volunteers aged between nine and 45 years across various locations in China.
The clinical trial outcomes indicated that Cecolin 9 provides robust protection against HPV types 16 and 18, which are also targeted by the existing two-valent vaccine.
Additionally, it is effective against five other HPV strains—31, 33, 45, 52, and 58—demonstrating a protection rate exceeding 98 percent against persistent infections that last longer than 12 months and achieving a full 100 percent protection rate against cervical infections.
For the demographic of girls aged nine to 17, only two doses of Cecolin 9 are necessary to generate an immune response comparable to that of women aged 18 to 26 who receive three doses.
Notably, for those aged 15 to 17, it is currently the only two-dose HPV vaccine available in China.
A comparative analysis affirmed that the immune responses elicited by the new vaccine remain on par with international counterparts for a minimum duration of 30 months post-immunization.
These findings have been documented in The Lancet Infectious Diseases.
Cecolin 9 follows the achievement of China's first domestically produced two-valent HPV vaccine, launched in 2019, which received prequalification from the World Health Organization (WHO) in 2021. This initial vaccine has since penetrated the markets of 21 countries.
As of 2022, cervical cancer ranked as the fourth most prevalent cancer among women worldwide, as reported by the WHO.
In alignment with its public health goals, China made HPV vaccination available for free to approximately 40 percent of girls aged 13 to 14 in 2024, reflecting its commitment to combat cervical cancer significantly.
This significant development positions China as the second country globally, following the United States, to independently offer high-valency HPV vaccines.
Cecolin 9 was developed through a collaborative effort involving the Xiang An Biomedicine Laboratory, Xiamen University, and Wantai BioPharm.
The approval comes after extensive clinical trials conducted since 2019, which included over 11,000 healthy volunteers aged between nine and 45 years across various locations in China.
The clinical trial outcomes indicated that Cecolin 9 provides robust protection against HPV types 16 and 18, which are also targeted by the existing two-valent vaccine.
Additionally, it is effective against five other HPV strains—31, 33, 45, 52, and 58—demonstrating a protection rate exceeding 98 percent against persistent infections that last longer than 12 months and achieving a full 100 percent protection rate against cervical infections.
For the demographic of girls aged nine to 17, only two doses of Cecolin 9 are necessary to generate an immune response comparable to that of women aged 18 to 26 who receive three doses.
Notably, for those aged 15 to 17, it is currently the only two-dose HPV vaccine available in China.
A comparative analysis affirmed that the immune responses elicited by the new vaccine remain on par with international counterparts for a minimum duration of 30 months post-immunization.
These findings have been documented in The Lancet Infectious Diseases.
Cecolin 9 follows the achievement of China's first domestically produced two-valent HPV vaccine, launched in 2019, which received prequalification from the World Health Organization (WHO) in 2021. This initial vaccine has since penetrated the markets of 21 countries.
As of 2022, cervical cancer ranked as the fourth most prevalent cancer among women worldwide, as reported by the WHO.
In alignment with its public health goals, China made HPV vaccination available for free to approximately 40 percent of girls aged 13 to 14 in 2024, reflecting its commitment to combat cervical cancer significantly.
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