mairuidong mifanertinib maleate tablet 45mg 28tablets per box or 60mg 28tablets per box

Description

Indication & Scope

MaiRuiDong® is a prescription irreversible EGFR tyrosine kinase inhibitor (EGFR-TKI) indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 21 L858R substitution mutations.

Mechanism: Mifanertinib maleate is an irreversible EGFR tyrosine kinase inhibitor that covalently binds to EGFR and HER2 kinases, inhibiting receptor phosphorylation and downstream signaling pathways to suppress tumor cell proliferation and survival.
Drug class: EGFR tyrosine kinase inhibitor (EGFR-TKI).
Clinical use: First-line treatment of EGFR exon 21 L858R mutation-positive locally advanced or metastatic NSCLC.

Specification

Generic Name	Mifanertinib Maleate Tablets
Brand Name	MaiRuiDong®
Ingredient	Mifanertinib Maleate
Dosage Form	Tablet
Package	45 mg × 28 tablets/box;60 mg × 28 tablets/box
Conditions Treated	EGFR L858R-positive locally advanced or metastatic NSCLC
Taboos	Hypersensitivity to mifanertinib maleate or any component of the product
Place of origin	China
Prescription type	Prescription Drug (Rx)
Storage Conditions	Store at room temperature.
Manufacturer	Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA), China
Approval number	H20250061;H20250062
Date of Revision	2025
Shelf Life	Refer to the approved package labeling.

How to use ?

Recommended Dose: The recommended dose is 60 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.

Time: Take once daily at approximately the same time each day. Tablets may be taken with or without meals.

Instructions for use: Swallow the tablets whole with water. Continue treatment until disease progression or unacceptable toxicity. Dose interruption, reduction, or discontinuation may be required to manage adverse reactions such as diarrhea, rash, or stomatitis. No initial dose adjustment is required for elderly patients or patients with mild to moderate hepatic or renal impairment.

Interaction: Mifanertinib maleate is primarily metabolized through non-CYP450 pathways and has low potential for clinically significant drug-drug interactions. No significant inhibition or induction of major CYP enzymes has been observed.

Side effects: Common adverse reactions include diarrhea, rash, stomatitis, paronychia, dry skin, pruritus, and elevated liver enzymes. Most adverse events are manageable with supportive care and dose modification.

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

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What is MaiRuiDong® used for?

MaiRuiDong® is indicated for the first-line treatment of adult patients with EGFR exon 21 L858R mutation-positive locally advanced or metastatic NSCLC.

What type of drug is Mifanertinib Maleate?

It is an irreversible EGFR tyrosine kinase inhibitor (EGFR-TKI).

How does Mifanertinib Maleate work?

It irreversibly inhibits EGFR signaling by covalently binding to EGFR and HER2 kinases, suppressing tumor cell growth.

How is MaiRuiDong® administered?

It is taken orally once daily, with or without food.