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JSKN016 injection
JSKN016 injection is a PD-1 inhibitor Small molecule drug developed by Jiangsu Alphamab Biopharmaceuticals Co., Ltd. It is currently in Phase 2 development for Non-small cell lung cancer, PD-L1 positive.
JSKN016 injection is a monoclonal antibody targeting PD-1.
JSKN016 injection is a monoclonal antibody targeting PD-1. Used for Non-small cell lung cancer, PD-L1 positive.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | JSKN016 injection |
|---|---|
| Sponsor | Jiangsu Alphamab Biopharmaceuticals Co., Ltd |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
It works by binding to PD-1 on T cells, preventing its interaction with PD-L1 on tumor cells, and thus enhancing the immune response against cancer cells.
Approved indications
- Non-small cell lung cancer, PD-L1 positive
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Rash
- Pyrexia
Key clinical trials
- JSKN016HC in Patients With Advanced or Metastatic Solid Malignant Tumors (PHASE1)
- Evaluation of JSKN016 Combination Therapy in Subjects with NSCLC (PHASE1)
- To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors (PHASE1)
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:
- JSKN016 injection CI brief — competitive landscape report
- JSKN016 injection updates RSS · CI watch RSS
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd portfolio CI
Frequently asked questions about JSKN016 injection
What is JSKN016 injection?
How does JSKN016 injection work?
What is JSKN016 injection used for?
Who makes JSKN016 injection?
What drug class is JSKN016 injection in?
What development phase is JSKN016 injection in?
What are the side effects of JSKN016 injection?
What does JSKN016 injection target?
Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Jiangsu Alphamab Biopharmaceuticals Co., Ltd — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer, PD-L1 positive
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing