Aireli®Adebrelimab Injection

1. ‌Indications and Usage‌
Indication‌: Adebrelimab Injection, in combination with ‌carboplatin and etoposide‌, is indicated for the ‌first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC)‌.
This approval is based on the results of the CAPSTONE-1 study, a multicenter, randomized, double-blind, placebo-controlled Phase III trial conducted in China.
2. ‌Dosage and Administration‌
Recommended Dose‌: ‌20 mg/kg‌ as an intravenous infusion every ‌3 weeks‌, in combination with carboplatin and etoposide for 4–6 cycles.
After induction, continue ‌Adebrelimab monotherapy‌ at the same dose and schedule until disease progression or unacceptable toxicity.
Infusion duration should be ≥60 minutes. If well tolerated, subsequent infusions may be shortened to ≥30 minutes.
Dose Modifications‌: May require interruption or discontinuation based on individual safety and tolerability, particularly for immune-mediated adverse reactions or severe infusion reactions.
3. ‌Mechanism of Action‌

Adebrelimab is a ‌humanized monoclonal antibody‌ targeting ‌programmed death-ligand 1 (PD-L1)‌. It blocks the interaction of PD-L1 with PD-1 and B7.1 receptors, thereby reactivating suppressed T-cell immune responses and enhancing anti-tumor activity.

4. ‌Safety and Warnings‌
Immune-Mediated Adverse Reactions‌: May include pneumonitis, colitis, hepatitis, endocrinopathies (e.g., thyroid disorders, adrenal insufficiency), nephritis, and skin reactions. Most are reversible with corticosteroids and treatment interruption.
Infusion-Related Reactions‌: Include chills, fever, chest tightness, pruritus, rash, hypotension, and hypoxemia. For Grade ≥3 reactions, discontinue infusion and permanently stop treatment.
Effects on Driving and Machinery‌: Fatigue has been reported; patients should exercise caution when driving or operating machinery.
Use in Special Populations‌:
Pregnancy and Lactation‌: Not studied; use only if potential benefit justifies potential fetal risk.
Pediatric Use‌: Safety and efficacy not established.
Elderly Patients‌: No dose adjustment required, but monitor closely due to increased susceptibility to adverse events.
5. ‌Adverse Reactions‌
Most Common (≥10%)‌: Proteinuria, fatigue, increased ACTH, elevated AST/ALT, increased TSH, hyperbilirubinemia, anemia, decreased appetite, rash.
Most Common ≥Grade 3‌: Pneumonitis, elevated ALT/AST, conjugated bilirubin increase, liver function abnormality, anemia, hypokalemia.
Hematologic Toxicity (from combination therapy)‌: Neutropenia (76%), leukopenia (46%), thrombocytopenia (38%), anemia (28%).
6. ‌Drug Interactions‌
No formal pharmacokinetic interaction studies conducted.
Due to its monoclonal antibody nature, metabolism via CYP450 enzymes is unlikely; thus, co-administration with CYP inhibitors or inducers is not expected to affect exposure.
Avoid systemic immunosuppressants (e.g., corticosteroids) before initiation unless for managing immune-mediated toxicities.
7. ‌Clinical Pharmacology‌
Target‌: PD-L1
Mechanism‌: Blockade of PD-1/PD-L1 pathway → T-cell activation → enhanced tumor cell killing.
Pharmacokinetics‌: Data not fully disclosed; typical monoclonal antibody profile with slow clearance and long half-life.
8. ‌Pharmaceutical Information‌
Brand Name‌: 艾瑞利® (Aireli®)
Generic Name‌: Adebrelimab Injection
Strength‌: 600 mg (12 mL)/vial
Manufacturer‌: Suzhou Salubris Biotherapeutics Co., Ltd. (a subsidiary of Hengrui Medicine)
Marketing Authorization Holder‌: Shanghai Hengrui Pharmaceuticals Co., Ltd.
Approval Date in China‌: March 3, 2023
Registration Number‌: 国药准字S20233106
Storage‌: Store refrigerated at 2–8°C; protect from light and freezing.