Cadonilimab

Generic Name/API:Cadonilimab

Packaging:1 vial per box

Storage:Store refrigerated at 2°C to 8°C, protected from light

Dosage:For dosage information, please check the General Information section.

Strength:125 mg (10 mL)/bottle

Indication:The specific, approved clinical indications for Cadonilimab include: Cervical Cancer: Indicated for persistent, recurrent, or metastatic cases, particularly for patients who have progressed on platinum-based chemotherapy, including as a first-line treatment in combination with chemotherapy. G/GEJ Adenocarcinoma: Approved for locally advanced unresectable or metastatic cases in combination with chemotherapy

Cadonilimab is a novel, first-in-class PD-1/CTLA-4 bi-specific immunotherapy drug. Cadonilimab was granted marketing approval by the NMPA of China for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy malignant tumors on June 29th, 2022.

In September 2024, Cadonilimab was approved for first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, in combination with fluoropyrimidine and platinum-based chemotherapy

In May 2025, Cadonilimab was approved for the first-line treatment of persistent, recurrent, or metastatic cervical cancer, in combination with platinum-based chemotherapy, with or without bevacizumab. All the above-approved indications are included in China’s latest National Reimbursement Drug List (NRDL).

STRENGTH:

125 mg (10 mL)/bottle

DOSAGE:

Recurrent/Metastatic Cervical Cancer

6 mg/kg IV infusion every 2 weeks (Q2W) until disease progression, unacceptable toxicity, or treatment discontinuation.

First-line Gastric/Gastroesophageal Junction Adenocarcinoma

10 mg/kg IV infusion every 3 weeks (Q3W).

ADVERSE REACTIONS:

Most common Treatment-related adverse events (TRAEs) (Any Grade, incidence ≥ 10%): ✓ anemia, 37(33.3%); ✓ hypothyroidism, 22(19.8%); ✓ alanine aminotransferase increased, 20(18.0%).
Most common ≥3 Grade TRAEs (incidence ≥ 1%): ✓ anemia, 6(5.4%); ✓ decreases appetite, 3(2.7%); ✓ dyspnea.
Most common Immune-mediated adverse events (irAEs) (Any Grade, incidence ≥ 1%): hypothyroidism, 15(13.5%); hyperthyroidism, 13(11.7%); blood thyroid stimulating hormone decreased, 4(3.6%).
Most common irAEs (≥3 Grade): immune-mediated pneumonitis, 1(0.9%); hyperthyroidism, 1(0.9%); myocarditis, 1(0.9%); myositis, 1(0.9%); hepatitis, 1(0.9%); thrombocytopenia, (0.9%); diarrhea, 1(0.9%).

STORAGE:

Store refrigerated at 2°C to 8°C , protected from light.

Immune-Related Adverse Events (irAEs): Because cadonilimab enhances the immune system, it can cause severe or fatal inflammation in various organs. This most commonly includes the lungs, liver, intestines, endocrine system and kidneys.

Symptoms to Monitor and Report

Always seek immediate medical attention if you experience any of the following toxicity warning signs:

Colitis (Intestines): Severe abdominal pain, diarrhea or blood in the stool.
Pneumonitis (Lungs): New or worsening cough, chest pain or shortness of breath.
Hepatitis (Liver): Yellowing of the skin or eyes (jaundice), severe nausea or dark urine.
Endocrinopathies: Extreme fatigue, headache, dizziness, rapid heart rate, weight changes or changes in mood/behavior.
Severe Skin Reactions: Rash, blistering or peeling skin