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HB0017 Q8W
HB0017 Q8W is a PD-1 inhibitor Biologic drug developed by Huabo Biopharm Co., Ltd.. It is currently in Phase 3 development for Non-small cell lung cancer, PD-L1 positive, Head and neck squamous cell carcinoma.
HB0017 Q8W is a monoclonal antibody targeting the PD-1 receptor.
HB0017 Q8W is being studied in a Phase III clinical trial for the treatment of moderate to severe plaque psoriasis. The study is a multicenter, randomized, double-blind, placebo-controlled trial that also includes HB0017 Q4W as an intervention.
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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 | HB0017 Q8W |
|---|---|
| Sponsor | Huabo Biopharm Co., Ltd. |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By binding to PD-1, HB0017 Q8W prevents the interaction with its ligands, PD-L1 and PD-L2, thereby releasing the inhibition on T cells and enhancing the immune response against cancer cells.
Approved indications
- Non-small cell lung cancer, PD-L1 positive
- Head and neck squamous cell carcinoma
Common side effects
- Pneumonitis
- Hypothyroidism
- Diarrhea
Key clinical trials
- A Phase 2 Study of HB0017 in Psoriasis Patients (PHASE2)
- Study of Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis (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:
- HB0017 Q8W CI brief — competitive landscape report
- HB0017 Q8W updates RSS · CI watch RSS
- Huabo Biopharm Co., Ltd. portfolio CI
Frequently asked questions about HB0017 Q8W
What is HB0017 Q8W?
How does HB0017 Q8W work?
What is HB0017 Q8W used for?
Who makes HB0017 Q8W?
What drug class is HB0017 Q8W in?
What development phase is HB0017 Q8W in?
What are the side effects of HB0017 Q8W?
What does HB0017 Q8W target?
Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Huabo Biopharm Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer, PD-L1 positive
- Indication: Drugs for Head and neck squamous cell carcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing