{"entity":{"id":"cecolin-9","kind":"drug","name":"Cecolin 9 (nine-valent HPV vaccine made in E. coli)","aka":["Cecolin9"],"tldr":"A nine-valent HPV vaccine produced in E. coli bacteria, authorised in China in May 2025; three years after vaccination, antibody levels in young women were no lower than with Gardasil 9.","summary":"Cecolin 9 is a second-generation nine-valent HPV vaccine derived from the WHO-prequalified Cecolin; the authors of its trial report state that it received marketing authorisation in China in May 2025. In a randomised, single-blind trial in Chinese women aged 18 to 26 (NCT04782895), type-specific immune responses were non-inferior to Gardasil 9 at month 7. In the three-year extension (NCT06197802), 403 of the 487 women enrolled (82.8%) were followed; the ratio of antibody concentrations (Cecolin 9 versus Gardasil 9) across the nine HPV types ranged from 0.78 to 1.91, meeting the non-inferiority margin for every type, and seropositivity ranged from 84.7% to 100.0% with Cecolin 9 and from 86.2% to 100.0% with Gardasil 9 (Zhong et al., Lancet Regional Health Western Pacific 2025). Antibody levels are a surrogate: the trial does not report cervical precancer or cancer outcomes. No WHO prequalification was found in the WHO list read on 4 November 2026.","status":"approved","asOf":"2026-11-04","links":[{"label":"Zhong et al., Lancet Regional Health Western Pacific 2025 (three-year follow-up)","url":"https://doi.org/10.1016/j.lanwpc.2025.101671"},{"label":"ClinicalTrials.gov NCT04782895","url":"https://clinicaltrials.gov/study/NCT04782895"},{"label":"ClinicalTrials.gov NCT06197802","url":"https://clinicaltrials.gov/study/NCT06197802"}],"tags":["preventive-vaccine","hpv-vaccine"],"related":["cecolin","gardasil-9"],"cancers":[],"sections":["prevention"],"technologies":["hpv-vaccine"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":["oncogenic-viruses"],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Cecolin 9","modality":"Prophylactic vaccine (virus-like particles)","mechanism":"Recombinant HPV L1 capsid proteins form virus-like particles that train the immune system to make antibodies against the HPV types the vaccine covers.","approvals":[{"region":"CN","year":2025,"indication":"Marketing authorisation in China, May 2025, as reported by the trial authors"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/cecolin-9/","neighbours":{"drug":[{"id":"cecolin","kind":"drug","name":"Cecolin (bivalent HPV vaccine, Xiamen Innovax)","route":"/drugs/cecolin/"},{"id":"gardasil-9","kind":"drug","name":"Nonavalent HPV vaccine","route":"/drugs/gardasil-9/"}],"section":[{"id":"prevention","kind":"section","name":"Prevention & Risk","route":"/fronts/prevention/"}],"technology":[{"id":"hpv-vaccine","kind":"technology","name":"HPV & HBV vaccination","route":"/technologies/hpv-vaccine/"}],"pathway":[{"id":"oncogenic-viruses","kind":"pathway","name":"Oncogenic viruses","route":"/pathways/oncogenic-viruses/"}]}}