Description
Indication & Scope
AnBiRui® (Andamertinib Benzoate) is an orally administered third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) developed for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations. By selectively targeting mutant EGFR signaling, Andamertinib Benzoate inhibits tumor cell proliferation and survival pathways, providing a targeted treatment option for patients with EGFR exon20 insertion-mutated NSCLC.
- Mechanism: Andamertinib Benzoate selectively inhibits mutant EGFR tyrosine kinase activity, including EGFR exon 20 insertion mutations, blocking downstream signaling pathways involved in tumor cell proliferation, survival, and progression.
- Drug class: Third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).
- Clinical use: Treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations who have progressed following platinum-based chemotherapy or are intolerant to platinum-based chemotherapy.
| Generic Name | Andamertinib Benzoate |
| Brand Name | AnBiRui® |
| Ingredient | Each capsule contains andamertinib benzoate. |
| Dosage Form | Capsule |
| Package | 40 mg × 1 capsule x 30/box |
| Conditions Treated | Adult patients with EGFR exon 20 insertion mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). |
| Taboos | Hypersensitivity to andamertinib benzoate or any component of the product. |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Refer to the approved package labeling. |
| Manufacturer | Avistone Pharmaceutical (Ningbo) Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20260023;H20260024 |
| Date of Revision | 2026 |
| Shelf Life | Refer to the approved package labeling |
How to use ?
Recommended Dose: 240 mg administered orally once daily according to the approved prescribing information.
Time: Administer once daily following the approved dosing schedule.
Instructions for use: Take orally as directed by a healthcare professional. Treatment should continue until disease progression or unacceptable toxicity. Dose adjustments may be required according to tolerability and clinical response.
Interaction: Andamertinib Benzoate may interact with drugs affecting CYP-mediated metabolism. Concomitant medications should be used according to the approved prescribing information.
Side effects: Common adverse reactions may include rash, diarrhea, decreased appetite, anemia, elevated liver enzymes, and skin-related adverse reactions.
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, indication, 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
What is its mechanism of action?
It irreversibly attaches to EGFR‑exon‑20 insertion‑mutated protein and blocks downstream signalling pathways, inhibiting proliferation of tumour cells.
What is its clinical advantage?
It is a domestic‑innovative Class‑1 new drug specifically targeting EGFR exon‑20 insertion mutations, which previously lacked effective oral targeted options in China. It brings new treatment choices for this difficult‑to‑treat NSCLC population.
How is AnBiRui administered?
The recommended dose is 240 mg orally once daily until disease progression or intolerable adverse reactions occur.
What indication is AnBiRui approved for?
It is indicated for adult patients with locally advanced or metastatic EGFR exon 20 insertion mutation-positive NSCLC.
AnBiRui®| Andamertinib Benzoate | EGFR Exon20‑Insertion‑Mutated NSCLC | DengYueRX
INN: Andamertinib Benzoate
Indications: EGFR exon 20 insertion-mutated NSCLC
Dosage Form: Capsule
Strength: 80 mg
