Description

Indication & Scope

HYRNUO® Sevabertinib Tablets treats adult patients with locally advanced or metastatic non-small cell lung cancer confirmed to carry HER2 activating mutations, who have received at least one prior systemic anti-tumor therapy.

Mechanism: Savolitinib is a reversible selective tyrosine kinase inhibitor. It tightly binds to the kinase domain of mutant HER2 protein, blocks HER2 phosphorylation and downstream cell proliferation signaling pathways, suppresses the uncontrolled growth and metastasis of HER2-mutated lung tumor cells, and induces cancer cell apoptosis. It also exhibits mild inhibitory activity against EGFR kinases.
Drug class: Oral small-molecule tyrosine kinase inhibitor; HER2 targeted anti-neoplastic agent.
Clinical use: First-line or subsequent-line targeted monotherapy for HER2 mutant late-stage NSCLC. It delivers durable tumor shrinkage, prolongs overall patient survival, and relieves lung cancer-related symptoms including persistent cough, hemoptysis and chest pain in clinical trials.

Specification

Generic Name	Sevabertinib Tablets
Brand Name	HYRNUO
Ingredient	Sevabertinib
Dosage Form	Tablets
Package	10mg*120 tablets/box
Conditions Treated	Adults with unresectable locally advanced or metastatic non-small cell lung cancer harboring HER2 tyrosine kinase domain activating mutations after previous systemic anti-cancer treatment
Taboos	Patients with severe hypersensitivity to savolitinib or tablet excipients; pregnant and breastfeeding women; patients with severe uncontrolled liver or renal failure
Place of origin	Kaiser-Wilhelm-Allee, 51368 Leverkusen, Germany
Prescription type	Prescription-only
Storage Conditions	Store sealed tablets at controlled room temperature 20°C–25°C, protected from high humidity and direct sunlight, keep inside original sealed bottle with desiccant
Manufacturer	Bayer AG
Registration Authority	National Medical Products Administration (NMPA), China
Approval number	HJ20260044
Approval Date	May 21, 2026
Shelf Life	24 months

How to use ?

Recommended Dose: Standard daily oral dose is 100mg once per day, taken continuously in 28-day treatment cycles. Adjust dose to 50mg daily or suspend treatment if severe adverse toxicities occur.

Time: Take one tablet orally at a fixed time every day, either with or without food. If a dose is missed, skip the forgotten tablet and resume regular dosing the next day; never take double doses.

Instructions for use: Swallow whole tablets with plain water, do not crush, split or chew the film-coated tablets. Conduct regular blood liver function and kidney function testing every two weeks during the first treatment cycle. Stop medication and contact doctors immediately if severe diarrhea, persistent skin rash or dyspnea occurs. Complete HER2 gene mutation testing before starting therapy to confirm eligibility.

Interaction: Strong CYP3A4 inhibitors (such as ketoconazole) increase savolitinib blood concentration and raise toxicity risk, requiring dose reduction. Strong CYP3A4 inducers (rifampicin, carbamazepine) lower anti-tumor efficacy and should be avoided. Combined anti-diarrhea drugs can relieve gastrointestinal side effects without major efficacy interference.

Side effects:

1. Common mild to moderate adverse reactions: diarrhea, nausea, fatigue, mild dry skin, elevated liver transaminase levels, mild peripheral edema.

2. Severe rare adverse reactions: severe interstitial lung disease, grade 3/4 liver function injury, severe vomiting leading to dehydration, severe rash with blisters.

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

Which lung cancer patients are eligible to take Sevabertinib Tablets for treatment?

Adult patients with advanced non-small cell lung cancer confirmed positive for HER2 gene mutations after at least one round of prior systemic anti-cancer therapy.

What is the most frequent mild side effect during treatment of Sevabertinib Tablets?

Mild diarrhea and slight nausea are the most common early symptoms, which can be controlled with anti-diarrhea medicine after consulting your oncologist.

What medicines should be avoided using while taking Sevabertinib Tablets this targeted lung cancer drug?

Strong liver enzyme inducing medicines like rifampicin and antifungal drugs such as ketoconazole need doctor evaluation before combined use, as they alter drug concentration.

How should Sevabertinib Tablets be stored at home safely?

Keep the original sealed bottle with desiccant at normal room temperature, stay away from damp bathrooms and direct sunlight, never split or crush the tablets.