Description
Indication & Scope
AnBiRui® Andamertinib Benzoate Capsules treats adult patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations, who progressed during or after platinum-based chemotherapy or cannot tolerate platinum combination chemotherapy.
- Mechanism: Andamertinib benzoate is an irreversible selective epidermal growth factor receptor tyrosine kinase inhibitor. It covalently binds to the mutant EGFR exon 20 insertion protein, irreversibly blocks EGFR downstream proliferation signaling, inhibits tumor cell division and metastasis, and effectively penetrates the blood-brain barrier to treat intracranial metastatic lung cancer lesions.
- Drug class: Oral irreversible EGFR-TKI small molecule; targeted anti-neoplastic agent for EGFR exon 20 insertion mutated NSCLC.
- Clinical use: Monotherapy for second-line or later treatment of EGFR exon 20 insertion mutated advanced NSCLC. It achieves stable tumor objective response, controls intracranial metastatic lesions, and alleviates lung cancer symptoms including persistent cough, dyspnea and bone metastatic pain in phase 2 clinical trials.
| Generic Name | Andamertinib Benzoate Capsules |
| Brand Name | AnBiRui |
| Ingredient | Andamertinib Benzoate |
| Dosage Form | Capsules |
| Package | 40mg(quantity to be determined);
80mg*30 capsules/box |
| Conditions Treated | Adults with unresectable locally advanced or metastatic NSCLC confirmed with EGFR exon 20 insertion mutations, with disease progression or intolerance to prior platinum-based chemotherapy regimens |
| Taboos | Patients with severe hypersensitivity to andamertinib benzoate or capsule excipients; pregnant and lactating women; patients with untreated severe interstitial lung disease |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Sealed capsules stored at room temperature 20°C–25°C, protected from high humidity and direct sunlight, retain inside original medicine bottle with built-in desiccant |
| Manufacturer | Asymchem Life Science (Tianjin) Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20260023; H20260024 |
| Approval Date | Apr 29, 2026 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Standard oral dose 240mg once daily, continuous administration in 28-day treatment cycles. Reduce dose to 160mg or suspend dosing for management of grade ≥3 treatment-related toxicities.
Time: Take capsules orally at a fixed time every day after meals to lower gastrointestinal irritation risk. If one daily dose is forgotten, skip the missed capsule and take regular dosage the next day; never double the dose.
Instructions for use: Swallow whole capsules with warm water, do not open, split or crush capsule shells. Conduct chest CT scan and liver function blood testing every two treatment cycles to screen interstitial lung disease and liver toxicity. Immediately stop medication and seek emergency care if unexplained dry cough or persistent shortness of breath develops. Complete EGFR exon 20 insertion gene testing before initiating treatment.
Interaction: Strong CYP3A4 inhibitors increase systemic andamertinib exposure and raise adverse toxicity risk, requiring mandatory dose reduction. Strong CYP3A4 enzyme inducers significantly reduce anti-tumor efficacy and must be avoided entirely during treatment. Antacid medicines should be taken 4 hours apart from this drug to prevent absorption interference.
Side effects:
1. Common mild to moderate adverse reactions: mild diarrhea, nausea, dry mouth, paronychia, mild elevated liver transaminase, skin dryness and acneiform rash.
2. Severe rare adverse reactions: severe interstitial lung disease, grade 3/4 liver damage, severe persistent diarrhea causing dehydration, severe ocular toxicities.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
Which lung cancer patients are suitable to take Andamertinib Benzoate Capsules?
Adult patients with advanced EGFR exon 20 insertion mutated lung cancer that worsened after platinum chemotherapy or who cannot stand platinum combination treatment.
Should this Andamertinib Benzoate Capsules targeted capsule should be on an empty stomach or after eating food?
It is recommended to take the capsule after meals every day to reduce stomach discomfort and nausea side effects.
What dangerous symptom is required to stop taking Andamertinib Benzoate Capsules and rush to hospital at once?
Unexplained persistent dry cough or sudden worsening shortness of breath may signal interstitial lung disease, which needs immediate medical evaluation.
What types of daily medicines should be avoided while taking Andamertinib Benzoate Capsules lung cancer targeted drug?
Strong liver enzyme accelerating drugs such as rifampicin and certain antifungal tablets will change drug effects and toxicity, so you must inform your oncologist of all other medicines you take.
AnBiRui® | Andamertinib Benzoate Capsules | Lung Cancer | DengYueRX
INN: Andamertinib Benzoate Capsules
Indications: Lung cancer
Dosage Form: Capsules
Strength: 40mg/capsule; 80mg/capsule
