Description
Indication & Scope
Befotertinib is an oral EGFR-targeted small-molecule agent for adult patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer, applied in first-line and second-line targeted treatment of NSCLC and used as monotherapy.
- Mechanism
As a third-generation reversible EGFR tyrosine kinase inhibitor, it selectively binds mutant EGFR protein, blocks downstream proliferation signaling pathways to suppress tumor growth and induce apoptosis of lung cancer cells. - Drug class
Class 1 innovative small-molecule chemical drug, third-generation EGFR-TKI, lung cancer targeted therapeutic agent. - Clinical use
Phase III clinical trials verified its durable anti-tumor efficacy and controllable safety for EGFR-mutant NSCLC; clinically administered orally at a daily dose of 75–100 mg, a domestic novel third-generation EGFR inhibitor covering exon 19 deletion, L858R and T790M mutations.
| Generic Name | Befotertinib Mesylate Capsules |
| Brand Name | SaiMeiNa® |
| Ingredient | Befotertinib Mesylate |
| Dosage Form | Capsule |
| Package | 25mg*40 capsule/box,50mg*20 capsule/box |
| Conditions Treated | First-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 19 deletion or exon 21 (L858R) substitution mutations and treatment for adult patients with locally advanced or metastatic non-small cell lung cancer with positive EGFR T790M mutation after progression on prior EGFR-TKI therapy |
| Taboos | Contraindicated for patients with hypersensitivity to the active ingredient or any excipients of this product, or those with severe allergic history |
| Place of origin | Zhejiang, China |
| Priscription Type | Prescription drug (Rx) |
| Storage Conditions | Seal tightly, store below 25℃ |
| Manufacturer | Betta Pharmaceuticals Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA) |
| Approval number | H20230011(25mg)/H20230012（50mg) |
| Date of Revision | May 31, 2023 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: Initial dose 75mg taken orally once daily; escalate to 100mg once daily if disease progression occurs, continuous administration until disease progression or intolerable toxicity.
Time: Take at fixed time every day; missed dose shall not be supplemented if more than 12 hours overdue.
Interaction:Oral capsule only, avoid strong CYP3A4 inhibitors or inducers during treatment. Monotherapy for EGFR-mutant NSCLC, routine combined chemotherapy is not recommended.
Side effects: Mild to moderate reactions common: rash, dry skin, diarrhea, stomatitis, elevated liver enzymes. Rare interstitial lung disease; severe anaphylactic reaction is extremely rare.
Important Notice
This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.
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 drugs should be avoided during medication?
Strong CYP3A4 inhibitors and strong CYP3A4 inducers should be avoided.
Can chemotherapy be routinely combined with this drug?
No, monotherapy is recommended, routine combined chemotherapy is not advised.
What gene mutations can Befotertinib target?
EGFR exon 19 deletion, exon 21 L858R substitution and EGFR T790M mutation.
What are the common adverse reactions of this drug?
Rash, dry skin, diarrhea, stomatitis and elevated liver enzymes are common mild-to-moderate side effects.
SaiMeiNa®Befotertinib Mesylate Capsules | NSCLC | DengYueRX
INN: Befotertinib Mesylate
Indications: NSCLC (Non-small cell lung cancer)
Dosage Form: Capsule
Strength: 25mg/capsule
