Home - Prescription Medicines - YiNuoXin® | Zurletrectinib Tablets | Solid Tumor | DengYueRX
Description
Indication & Scope
treats locally advanced or metastatic solid tumors harboring NTRK gene fusion in patients aged 12 years and older.
- Mechanism: Next-generation highly selective tropomyosin receptor kinase inhibitor (TRKA/TRKB/TRKC and ROS1 inhibitor). It binds ATP-binding pocket of NTRK fusion-derived TRK oncoproteins, blocks downstream tumor proliferation signaling pathways and induces cancer cell apoptosis, with strong blood-brain barrier penetration for intracranial metastatic lesions.
- Drug class: Oral small-molecule NTRK/ROS1 tyrosine kinase inhibitor / Pan-TRK anti-tumor targeted therapy.
- Clinical use: First-line targeted therapy for unresectable NTRK fusion-positive solid tumors across multiple tissue origins; effective for patients with central nervous system metastasis resistant to first-generation TRK inhibitors.
| Generic Name | Zurletrectinib Tablets |
| Brand Name | YiNuoXin |
| Ingredient | Zurletrectinib |
| Dosage Form | Tablets |
| Package | 4mg*60 tablets/box |
| Conditions Treated | NTRK fusion-positive locally advanced or metastatic solid tumors |
| Taboos | Severe hypersensitivity to zurletrectinib or tablet excipients; patients with severe untreated hepatic impairment; pregnant or breastfeeding individuals |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store sealed blister packs at controlled room temperature 10°C to 30°C, sealed to prevent moisture ingress |
| Manufacturer | Innocare Pharmaceutical, Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250071 |
| Approval Date | Dec 9, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Standard dose 100 mg oral twice daily, taken continuously until disease progression or intolerable toxicity occurs.
Time: Two equal doses administered at 12-hour intervals daily, with consistent food intake (low-fat meals recommended).
Instructions for use: Swallow whole tablet with water, do not split or crush; adjust dose downward for grade 3 or higher liver toxicities; perform baseline NTRK fusion genetic testing before treatment initiation.
Interaction: Strong CYP3A4 inhibitors increase systemic zurletrectinib exposure and toxicity risk; strong CYP3A4 inducers significantly reduce therapeutic plasma concentrations.
Side effects:
1. Common: mild fatigue, dizziness, nausea, diarrhea, elevated liver transaminases, myalgia.
2. Severe grade ≥3 adverse events: severe hepatotoxicity, sensory peripheral neuropathy, interstitial lung disease.
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 gene mutation must patients have to qualify for Zurletrectinib Tablets treatment?
Patients must harbor NTRK gene fusion positive advanced solid tumors.
What two kinase protein families does Zurletrectinib Tablets inhibit?
It inhibits TRKA/B/C tropomyosin receptor kinases and ROS1 kinase.
What key advantage does Zurletrectinib Tablets have over older first-generation TRK inhibitors?
It possesses strong blood-brain barrier penetration activity for brain metastatic lesions.
What liver lab abnormality is a common dose-limiting side effect during therapy of Zurletrectinib Tablets?
Elevated liver ALT and AST transaminase enzymes.
YiNuoXin® | Zurletrectinib Tablets | Solid Tumor | DengYueRX
INN: Zurletrectinib Tablets
Indications: Malignant solid tumor
Dosage Form: Tablets
Strength: 4mg/tablet