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Stapokibart injection
Stapokibart injection is a Biologic drug developed by Chengdu Kangnuoxing Biopharma,Inc.. It is currently in Phase 3 development.
Stapokibart injection is designed to target and modulate a specific pathway involved in the disease process, though the exact mechanism is not publicly detailed.
Stapokibart injection is an antibody-based treatment being studied for various conditions, including Bullous Pemphigoid, Chronic Sinusitis, Lung Cancer, CRSWNP, and Prurigo Nodularis. It is being evaluated in a randomized, double-blind, placebo-controlled Phase III clinical study to assess its efficacy and safety.
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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).
| 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 | Stapokibart injection |
|---|---|
| Sponsor | Chengdu Kangnuoxing Biopharma,Inc. |
| Modality | Biologic |
| Phase | Phase 3 |
Mechanism of action
While the precise mechanism of action for Stapokibart is not fully disclosed, it is known to interact with a biological pathway relevant to its therapeutic area, potentially leading to improved outcomes in patients with the targeted condition.
Approved indications
Common side effects
Key clinical trials
- A Study of Stapokibart Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) .
- A Prospective Study of Stapokibart Injection in Patients With Seasonal Allergic Rhinitis (SAR)
- Efficacy and Safety of Stapokibart in Non-Allergic Rhinitis With Eosinophilia Syndrome (NA)
- Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid (PHASE3)
- A Study Evaluating the Efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) Combined With Stapokibart in the Treatment of Type 2 Chronic Rhinosinusitis (NA)
- Study on the Treatment of Prurigo Nodularis With Stapokibart Injection (PHASE3)
- An Open-label, Single-arm Clinical Study of Stapokibart Injection in Combination with Tislelizumab Injection in Patients with Non-Small Cell Lung Cancer (PHASE2)
- Study of Stapokibart Injection in Patients With Allergic Rhinitis (PHASE2)
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:
- Stapokibart injection CI brief — competitive landscape report
- Stapokibart injection updates RSS · CI watch RSS
- Chengdu Kangnuoxing Biopharma,Inc. portfolio CI
Frequently asked questions about Stapokibart injection
What is Stapokibart injection?
How does Stapokibart injection work?
Who makes Stapokibart injection?
What development phase is Stapokibart injection in?
Related
- Manufacturer: Chengdu Kangnuoxing Biopharma,Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing