Description
Indication & Scope
MaiRuiDong® Mifanertinib Maleate Tablet treats adult patients with locally advanced or metastatic non-small cell lung cancer carrying EGFR activating mutations.
- Mechanism: Mifanertinib maleate is an oral dual EGFR/HER2 tyrosine kinase inhibitor. It competitively binds the ATP pocket of mutant EGFR kinase domains, blocks downstream RAS/RAF proliferative signaling, inhibits EGFR-mutant lung cancer cell growth and suppresses metastatic spread.
- Drug class: Oral EGFR tyrosine kinase inhibitor; small molecule targeted anti-cancer agent.
- Clinical use: First-line monotherapy for EGFR-mutant locally advanced and metastatic NSCLC; provides durable tumor control for patients with EGFR exon 19 deletion and L858R substitution mutations.
| Generic Name | Mifanertinib Maleate Tablets |
| Brand Name | MaiRuiDong |
| Ingredient | Mifanertinib Maleate |
| Dosage Form | Tablets |
| Package | 45mg*28 tablets/box;
60mg*28 tablets/box |
| Conditions Treated | Locally advanced or metastatic non-small cell lung cancer with confirmed EGFR activating mutations |
| Taboos | Severe hypersensitivity to mifanertinib maleate or tablet inactive ingredients; patients with untreated grade 2+ interstitial lung disease |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store in sealed blister packs at 15°C–30°C, avoid damp storage environments |
| Manufacturer | ZhongMeiHuaDong Pharmaceutical, Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250061; H20250062 |
| Approval Date | Oct 21, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: 150 mg oral once daily continuous administration.
Time: Fixed daily dosing time, taken with or without food.
Instructions for use: Swallow tablets whole with plain water; grapefruit and grapefruit juice are prohibited during treatment. Conduct monthly pulmonary and liver function monitoring.
Interaction: Strong CYP3A4 inhibitors increase systemic mifanertinib exposure and toxic risk; CYP3A4 inducers drastically reduce therapeutic efficacy.
Side effects:
1. Common adverse reactions: diarrhea, paronychia, dry skin, stomatitis, elevated transaminases, QT interval prolongation.
2. Severe rare adverse events: severe interstitial lung disease, grade 3 persistent diarrhea, corneal epithelial erosion.
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
What is the main indication of Mifanertinib Maleate Tablets?
It treats locally advanced or metastatic non-small cell lung cancer with confirmed EGFR activating mutations in adults.
What food is strictly prohibited during medication of Mifanertinib Maleate Tablets?
Grapefruit and grapefruit juice are forbidden to avoid affecting drug metabolism.
What are the common skin adverse reactions of Mifanertinib Maleate Tablets?
Dry skin, paronychia and stomatitis are common skin and mucosal adverse reactions.
How do CYP3A4 inducers affect the efficacy of Mifanertinib Maleate Tablets?
They will greatly reduce the blood drug concentration and significantly weaken the therapeutic efficacy.
MaiRuiDong® | Mifanertinib Maleate Tablets | Lung Cancer | DengYueRX
INN: Mifanertinib Maleate Tablets
Indications: Lung cancer
Dosage Form: Tablets
Strength: 45mg/tablet; 60mg/tablet
