# Cecolin 9 (nine-valent HPV vaccine made in E. coli)

Source: https://onco.cc/drugs/cecolin-9/  
OnCo record `cecolin-9` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-11-04
- Also known as: Cecolin9
- Tags: preventive-vaccine; hpv-vaccine
- 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: CN 2025: Marketing authorisation in China, May 2025, as reported by the trial authors

## Sources

- Zhong et al., Lancet Regional Health Western Pacific 2025 (three-year follow-up): https://doi.org/10.1016/j.lanwpc.2025.101671
- ClinicalTrials.gov NCT04782895: https://clinicaltrials.gov/study/NCT04782895
- ClinicalTrials.gov NCT06197802: https://clinicaltrials.gov/study/NCT06197802

## Connected records

- drugs: [Cecolin (bivalent HPV vaccine, Xiamen Innovax)](https://onco.cc/drugs/cecolin/), [Nonavalent HPV vaccine](https://onco.cc/drugs/gardasil-9/)
- fronts: [Prevention & Risk](https://onco.cc/fronts/prevention/)
- technologies: [HPV & HBV vaccination](https://onco.cc/technologies/hpv-vaccine/)
- pathways: [Oncogenic viruses](https://onco.cc/pathways/oncogenic-viruses/)

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