Anniko Penpulimab Injection

1. Indications and Usage
Classic Hodgkin Lymphoma: Indicated for adult patients with at least second-line systemic chemotherapy-refractory, relapsed or refractory classic Hodgkin lymphoma.
Non-Small Cell Lung Cancer (NSCLC): In combination with paclitaxel and carboplatin, indicated for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer.
2. Dosage and Administration
Recommended Dosage: 200 mg administered intravenously every 2 weeks.
Treatment Duration: Continue until disease progression or unacceptable toxicity.
Administration Details: Administer via intravenous infusion over 60 minutes (extend to 120 minutes if intolerable). Do not administer as an intravenous push or bolus.
Preparation: Dilute with 0.9% Sodium Chloride Injection to a final concentration of 1.0-5.0 mg/mL. Use a low-protein binding 0.22 μm filter. Discard any unused portion.
3. Mechanism of Action
PD-1 Blockade: Penpulimab is a recombinant humanized IgG4 monoclonal antibody that specifically targets programmed cell death-1 (PD-1).
Immune Reactivation: By binding to PD-1 on T cells, it blocks the interaction with its ligands (PD-L1 and PD-L2), thereby reinvigorating anti-tumor immune responses and promoting tumor cell killing.
4. Safety and Warnings
Immune-Mediated Adverse Reactions: Severe and fatal immune-mediated reactions can occur (e.g., pneumonitis, colitis, hepatitis, nephritis, endocrinopathies). Monitor closely and manage with corticosteroids, dose interruption, or permanent discontinuation.
Infusion-Related Reactions: Monitor for signs of hypersensitivity during and after infusion.
Embryo-Fetal Toxicity: Can cause fetal harm. Effective contraception is required during and for 5 months after the final dose.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Hypothyroidism, increased alanine aminotransferase, rash, increased aspartate aminotransferase, and anemia.
Serious Adverse Reactions: Immune-mediated pneumonitis, colitis, hepatitis, infusion-related reactions, and infectious pneumonias.
Clinical Research Highlights: Clinical trials have demonstrated significant objective response rates in refractory classic Hodgkin lymphoma and improved outcomes in squamous NSCLC when combined with chemotherapy.
6. Drug Interactions
Immunosuppressive Agents: Concomitant use of systemic corticosteroids or other immunosuppressants may reduce the efficacy of penpulimab.
Live Vaccines: Avoid live vaccines during treatment.
Chemotherapy: When used for NSCLC, interactions with paclitaxel and carboplatin are managed according to their standard dosing guidelines.
7. Pharmaceutical Information
Chemical Composition: Active ingredient: Penpulimab.
Appearance: Colorless to pale yellow clear liquid.
Packaging: Supplied in single-use vials (100 mg/10 mL).
Storage: Store at 2°C to 8°C; do not freeze or shake. Protect from light.