Description
Indication & Scope
Hernexeos® is a prescription HER2-selective tyrosine kinase inhibitor (TKI) indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating HER2 (ERBB2) tyrosine kinase domain (TKD) mutations.
- Mechanism: Zongertinib is a highly selective, irreversible HER2 tyrosine kinase inhibitor that blocks HER2 signaling and inhibits tumor cell proliferation.
- Drug class: HER2-selective irreversible tyrosine kinase inhibitor (TKI).
- Clinical use: Treatment of HER2-mutant locally advanced or metastatic NSCLC.
| Generic Name | Zongertinib Tablets |
| Brand Name | Hernexeos® |
| Ingredient | Zongertinib |
| Dosage Form | Tablet |
| Package | 60 mg x 60 tablets/box |
| Conditions Treated | Locally advanced or metastatic HER2-mutant NSCLC |
| Taboos | Hypersensitivity to zongertinib or any component of the product |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store below 30°C in the original package. Protect from moisture. |
| Manufacturer | Boehringer Ingelheim International GmbH |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | Refer to the approved package labeling. |
| Date of Revision | 2025 |
| Shelf Life | Refer to the approved package labeling. |
How to use ?
Recommended Dose: The recommended dose is 120 mg orally once daily (two 60 mg tablets), with or without food, until disease progression or unacceptable toxicity.
Time: Take the tablets once daily at approximately the same time each day. Tablets should be swallowed whole and should not be crushed, chewed, or split.
Instructions for use: Administer orally with or without food. Continue treatment until disease progression or unacceptable toxicity. Dose interruption, reduction, or permanent discontinuation may be required to manage adverse reactions. Regular monitoring of liver function and pulmonary symptoms is recommended during treatment, particularly for signs of hepatotoxicity or interstitial lung disease (ILD)/pneumonitis.
Interaction: Zongertinib has no clinically significant CYP-mediated drug interactions currently identified. However, caution is advised when co-administered with strong CYP3A inhibitors or inducers until additional clinical data become available.
Side effects: Common adverse reactions include diarrhea, elevated liver enzymes, rash, nausea, fatigue, decreased appetite, and interstitial lung disease (ILD)/pneumonitis. Most adverse reactions are manageable with appropriate dose modification and supportive care.
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 Hernexeos® (Zongertinib) used for?
Hernexeos® is indicated for the treatment of adults with locally advanced or metastatic HER2-mutant non-small cell lung cancer (NSCLC).
How is Hernexeos® administered?
It is taken orally once daily (120 mg), with or without food, until disease progression or unacceptable toxicity.
Is HER2 testing required before treatment?
Yes. Patients should have confirmed activating HER2 (ERBB2) tyrosine kinase domain (TKD) mutations before starting treatment.
What are the most common side effects?
Common adverse reactions include diarrhea, elevated liver enzymes, rash, nausea, fatigue, decreased appetite, and interstitial lung disease (ILD)/pneumonitis.
Hernexeos® | Zongertinib | NSCLC | DengYueRX
INN: Zongertinib
Indications: HER2-mutant NSCLC
Dosage Form: Tablet
Strength: 60 mg/Tablet
