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Active Comparator: GARDASIL ®9
Active Comparator: GARDASIL ®9 is a Recombinant HPV vaccine Biologic drug developed by Shanghai Bovax Biotechnology Co., Ltd.. It is currently in Phase 3 development for Prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, 58, Prevention of genital warts caused by HPV types 6, 11, Prevention of anal cancer and other HPV-related cancers.
GARDASIL 9 is a recombinant human papillomavirus (HPV) vaccine that stimulates the immune system to produce antibodies against nine HPV types to prevent infection and associated cancers.
GARDASIL 9 is an active comparator in a clinical study evaluating its immunogenicity and safety in Chinese healthy females. The study is a randomized, double-blind, and positive-controlled Phase 3 study to evaluate the immunogenicity and safety of a 9-valent HPV recombinant vaccine in comparison to GARDASIL 9.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Active Comparator: GARDASIL ®9 |
|---|---|
| Sponsor | Shanghai Bovax Biotechnology Co., Ltd. |
| Drug class | Recombinant HPV vaccine |
| Target | Human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, 58 |
| Modality | Biologic |
| Therapeutic area | Oncology / Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
GARDASIL 9 contains virus-like particles (VLPs) derived from nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, and 58). When administered, these VLPs trigger a humoral immune response that generates neutralizing antibodies against the targeted HPV types, preventing viral infection of epithelial cells and reducing the risk of HPV-related malignancies and genital warts. The vaccine provides protection against both low-risk HPV types (6, 11) that cause benign warts and high-risk types (16, 18, 31, 33, 45, 52, 58) associated with cervical, anal, and other cancers.
Approved indications
- Prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, 58
- Prevention of genital warts caused by HPV types 6, 11
- Prevention of anal cancer and other HPV-related cancers
Common side effects
- Injection site pain/soreness
- Injection site swelling
- Injection site erythema
- Headache
- Fever
- Nausea
Key clinical trials
- Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls (PHASE3)
- Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Active Comparator: GARDASIL ®9 CI brief — competitive landscape report
- Active Comparator: GARDASIL ®9 updates RSS · CI watch RSS
- Shanghai Bovax Biotechnology Co., Ltd. portfolio CI
Frequently asked questions about Active Comparator: GARDASIL ®9
What is Active Comparator: GARDASIL ®9?
How does Active Comparator: GARDASIL ®9 work?
What is Active Comparator: GARDASIL ®9 used for?
Who makes Active Comparator: GARDASIL ®9?
What drug class is Active Comparator: GARDASIL ®9 in?
What development phase is Active Comparator: GARDASIL ®9 in?
What are the side effects of Active Comparator: GARDASIL ®9?
What does Active Comparator: GARDASIL ®9 target?
Related
- Drug class: All Recombinant HPV vaccine drugs
- Target: All drugs targeting Human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, 58
- Manufacturer: Shanghai Bovax Biotechnology Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology / Immunology / Infectious Disease
- Indication: Drugs for Prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, 58
- Indication: Drugs for Prevention of genital warts caused by HPV types 6, 11
- Indication: Drugs for Prevention of anal cancer and other HPV-related cancers
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing