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Penpulimab kcqx (PENPULIMAB)
Penpulimab works by binding to the PD-1 protein on immune cells, blocking its interaction with the PD-L1 protein on cancer cells and allowing the immune system to attack the cancer.
At a glance
| Generic name | PENPULIMAB |
|---|---|
| Sponsor | Akeso Biopharma |
| Target | Pd-1 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Penpulimab-kcqx injection is a humanized IgG1 monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In murine tumor models, blocking PD-1 activity resulted in decreased tumor growth.
Approved indications
- Recurrent or Metastatic Non-Keratinizing Nasopharyngeal Carcinoma
- Metastatic Non-Keratinizing Nasopharyngeal Carcinoma with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
Common side effects
- Nausea
- Vomiting
- Hypothyroidism
- Constipation
- Decreased appetite
- Decreased weight
- Cough
- COVID-19 infection
- Fatigue
- Rash
- Pyrexia
- Anemia
Key clinical trials
- A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma (PHASE2)
- Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C (PHASE1,PHASE2)
- Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer (PHASE2)
- A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma (PHASE2)
- Phase II Study of LM-24C5 (PHASE2)
- A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (PHASE2)
- Anlotinib, Penpulimab and Capecitabine in Recurrent/Metastatic Nasopharyngeal Carcinoma (PHASE2)
- Anlotinib Plus Penpulimab as Second-line Treatment for Patients With Small Cell Lung Cancer After Failure of Platinum-based Chemotherapy (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Penpulimab kcqx CI brief — competitive landscape report
- Penpulimab kcqx updates RSS · CI watch RSS
- Akeso Biopharma portfolio CI