Last reviewed · How we verify
genakumab
genakumab is a Small molecule drug developed by Changchun GeneScience Pharmaceutical Co., Ltd.. It is currently in Phase 3 development. Also known as: • Gensci048, Tislelizumab.
-
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 | genakumab |
|---|---|
| Also known as | • Gensci048, Tislelizumab |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Clinical Study of Multiple Dose Genakumab for Injection in Chinese Healthy Adults (PHASE1)
- Clinical Study of Genakumab for Injection in Patients With Acute Gout (PHASE1, PHASE2)
- A Bioequivalence Study of Two Different Dosage Form of Genakumab (PHASE1)
- A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease (PHASE2)
- A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202) (PHASE2)
- Safety & Efffficacy of Genakumab in Patients With Frequent Flares (PHASE3)
- Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare (PHASE2)
- To Evaluate the Efficacy and Safety of Genalumab for Injection in the Treatment of Active Systemic Juvenile Idiopathic Arthritis. (NA)
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:
- genakumab CI brief — competitive landscape report
- genakumab updates RSS · CI watch RSS
- Changchun GeneScience Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about genakumab
What is genakumab?
Who makes genakumab?
Is genakumab also known as anything else?
What development phase is genakumab in?
Related
- Manufacturer: Changchun GeneScience Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: • Gensci048, Tislelizumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing