Ivonescimab Injection

The English version of the instructions for Ivonescimab Injection can be obtained through the official channels of China National Medical Products Administration (NMPA) and Kangfang Biotechnology. The following is a summary of the core content based on the approval document:

1. ‌Indications and Usage‌
Indications: Ivonescimab Injection is a bispecific antibody that targets PD-1 and VEGF-A, used to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with disease progression after platinum based chemotherapy.
This indication was conditionally approved by NMPA based on the results of a phase II clinical trial conducted in China (first approved in May 2024), demonstrating anti-tumor activity in both PD-L1 positive and negative patients.
2. ‌Dosage and Administration‌
Recommended dose: 7.5 mg/kg intravenous infusion, once every 3 weeks (Q3W), infusion time should be ≥ 60 minutes.
It can be used in combination with other standard treatments (such as chemotherapy), and the specific plan needs to be formulated by the doctor according to the patient’s condition.
Dose adjustment:
When there are ≥ 3 grade infusion related reactions or immune-mediated toxicity, medication should be suspended and evaluated.
If serious adverse reactions occur (such as pneumonia, colitis, hepatitis, etc.), the medication should be permanently discontinued or treatment should be resumed under specialized guidance.
3. ‌Mechanism of Action‌

Ivonescimab is the world’s first PD-1/VEGF dual antibody to enter phase III clinical trials, achieving a dual anti-tumor effect of “immune activation+anti angiogenesis” by simultaneously blocking the PD-1 immune checkpoint pathway and VEGF angiogenesis pathway. Its structural design enhances tissue penetration and target occupancy, improving therapeutic potential.

4. ‌Safety and Warnings‌
Immune mediated adverse reactions: may include pneumonia, colitis, hepatitis, endocrine disorders (such as thyroid dysfunction, pituitary inflammation), nephritis, etc., which require timely monitoring and treatment with glucocorticoids.
Bleeding risk: Inhibiting the VEGF pathway may increase bleeding events (such as nosebleeds and hemoptysis), and individuals with a history of severe hemoptysis should use with caution.
Thrombotic events: When arterial or venous thromboembolic events (such as pulmonary embolism, cerebral infarction) are observed, high-risk populations should be alerted.
Embryo fetal toxicity: Animal studies have shown that it can cause fetal damage. It is recommended that women with fertility potential take effective contraceptive measures during treatment and for at least 6 months after the last dose.
Infusion related reactions: About 10% of patients report mild to moderate reactions (such as fever, chills, itching), and it is recommended to use antihistamines and antipyretics in advance.
5. ‌Adverse Reactions‌
Common adverse reactions (≥ 20%):
Anemia, neutropenia, thrombocytopenia, fatigue, decreased appetite, cough, diarrhea, and elevated AST/ALT.
≥ Grade 3 adverse reactions:
Neutropenia (about 28%), anemia (about 22%), thrombocytopenia (about 15%), elevated liver enzymes, pneumonia.
Laboratory abnormality:
Decreased blood cells, abnormal liver function, and dyslipidemia are common and can mostly be managed through supportive therapy.
6. ‌Drug Interactions‌
Formal drug interaction studies have not yet been conducted.
The combination with other immunotherapy drugs (such as CTLA-4 antibodies) or anti angiogenic drugs (such as bevacizumab) may increase the risk of toxicity and should be carefully evaluated.
It can be used in combination with platinum containing dual drug chemotherapy regimens and has been validated for safety in clinical trials.
7. ‌Pharmaceutical Information‌
Product Name: Ivonescimab
Common name: Ivonescimab Injection
R&D company: Akeso, Inc
NMPA approval status: conditionally approved in May 2024, currently listed in Chinese Mainland
Storage conditions: Refrigerate at 2-8 ° C, store away from light, do not freeze; Stable for 24 hours at 2-8 ° C and 6 hours at room temperature after reconstitution