Description
Indication & Scope
XuanFeiNing® is a prescription ALK tyrosine kinase inhibitor (ALK-TKI) indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors are positive for anaplastic lymphoma kinase (ALK) fusion.
- Mechanism: Dirozalkib is a selective ALK tyrosine kinase inhibitor that competitively binds to the ALK kinase domain and inhibits ALK signaling, including wild-type ALK and common resistance mutations. By blocking downstream PI3K-AKT and RAS-MAPK pathways, Dirozalkib suppresses tumor cell proliferation and survival.
- Drug class: Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (ALK-TKI).
- Clinical use: Treatment of adults with ALK fusion-positive locally advanced or metastatic NSCLC.
| Generic Name | Dirozalkib Tablets |
| Brand Name | XuanFeiNing® |
| Ingredient | Dirozalkib |
| Dosage Form | Tablet |
| Package | 50 mg × 28 tablets/box; 250 mg × 56 tablets/box |
| Conditions Treated | ALK fusion-positive locally advanced or metastatic non-small cell lung cancer |
| Taboos | Hypersensitivity to dirozalkib or any component of the product |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store in a sealed container at room temperature (10–30°C), protected from light and moisture. |
| Manufacturer | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Registration Authority | Xuanzhu Biopharmaceutical Co., Ltd. |
| Approval number | H20250055;H20250056 |
| Date of Revision | 2025 |
| Shelf Life | Refer to the approved package labeling. |
How to use ?
Recommended Dose: The recommended dose is 250 mg orally once daily with or without food. Treatment should continue until disease progression or unacceptable toxicity.
Time: Administer at approximately the same time each day. Tablets should be swallowed whole and should not be crushed, chewed, or split.
Instructions for use: Confirm ALK fusion positivity using an approved diagnostic method before initiating treatment. Dose interruption or reduction may be required based on the severity of adverse reactions. If a dose is missed, patients should skip the missed dose and take the next dose at the regular scheduled time. A double dose should not be taken.
Interaction: Dirozalkib is primarily metabolized by CYP3A4. Strong CYP3A4 inhibitors may increase drug exposure, while strong CYP3A4 inducers may reduce therapeutic effects. Concomitant use with strong CYP3A4 inducers should be avoided.
Side effects: Common adverse reactions include increased transaminases, diarrhea, nausea, constipation, fatigue, peripheral edema, and visual disorders. Other potential adverse reactions include myalgia, weight gain, bradycardia, interstitial lung disease, and hyperlipidemia.
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 XuanFeiNing® used for?
XuanFeiNing® is used for adults with ALK fusion-positive locally advanced or metastatic non-small cell lung cancer.
How does it work?
It inhibits ALK tyrosine kinase activity and blocks downstream signaling pathways involved in tumor growth and survival.
How is Dirozalkib administered?
Dirozalkib is administered orally at a recommended dose of 250 mg once daily.
What tests are required before treatment?
Patients should undergo ALK fusion testing using validated diagnostic methods such as NGS or FISH before starting treatment.
XuanFeiNing® | Dirozalkib | ALK-positive Non-Small Cell Lung Cancer | DengYueRX
INN: Dirozalkib
Indications: ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)
Dosage Form: Tablet
Strength: 50 mg/Tablet; 250 mg/Tablet
