Sevabertinib Tablets 10 mg Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 10 mg
Reference Brands: Hyrnuo
Category: Oncology Cancer Care
Sevabertinib (Hyrnuo, Bayer) is an oral HER2 kinase inhibitor for non-small cell lung cancer with HER2 (ERBB2) mutations, approved by the US FDA in November 2025 and in Japan in August 2026. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers, API makers and licensees preparing for patent expiry.
Manufacture or export Sevabertinib Tablets? List it or send an offer →
Product Description:
Sevabertinib is a reversible tyrosine kinase inhibitor that targets mutated HER2 (ERBB2). Activating HER2 mutations, usually exon 20 insertions, occur in roughly 2 to 4 percent of non-small cell lung cancers.
The US FDA granted sevabertinib accelerated approval as Hyrnuo in November 2025 for previously treated, HER2-mutant, non-squamous non-small cell lung cancer, and extended it to first-line treatment in September 2026. Japan approved it in August 2026. A test confirming the HER2 mutation is needed before treatment. It is supplied as 10 mg tablets.
Sourcing and licensing notes. Sevabertinib is patented and made only by Bayer; there is no generic. Its HER2-mutant lung cancer competitor is zongertinib (Hernexeos), also listed on PharmaTradz. We handle authorised-supply enquiries and connect developers and licensees interested in the molecule ahead of patent expiry.
How Sevabertinib Tablets is supplied today, and licensing ahead of patent expiry
Where sevabertinib is approved
Checked 3 Oct 2026| Market | Status | Brand · regulator · date |
|---|---|---|
| United States | Approved | Hyrnuo · FDA · Nov 2025 (accelerated); first-line added Sep 2026 |
| Japan | Approved | Hyrnuo · MHLW · Aug 2026 |
| Generic / biosimilar | None | None approved as of the check date |
Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →
Frequently Asked Questions
Non-squamous non-small cell lung cancer with HER2 (ERBB2) mutations.
Hyrnuo, from Bayer. The US FDA approved it in November 2025, and Japan in August 2026.
Both are oral HER2-selective kinase inhibitors for HER2-mutant lung cancer. Sevabertinib is from Bayer and zongertinib (Hernexeos) from Boehringer Ingelheim.
No. It is patented. We handle authorised-supply enquiries and connect developers and licensees preparing for patent expiry.
Related Products
Relacorilant Capsules
Strength:
25 mg, 100 mg
Form: Soft capsules
Reference Brands: Lifyorli
View DetailsSonrotoclax Tablets
Strength:
1 mg, 5 mg, 20 mg, 80 mg
Form: Tablets
Reference Brands: Beqalzi
View Details
Pexidartinib Hydrochloride
Strength:
200 mg
Form: Capsules
Reference Brands: Turalio (USA/EU)
View Details
Mechlorethamine Hydrochloride
Strength:
0.016%
Form: Topical Gel
Reference Brands: Valchlor (USA), Ledaga (EU/LATAM/UK)
View Details
Valrubicin
Strength:
40 mg/mL
Form: Intravesical solution
Reference Brands: Valstar (USA)
View Details
Quizartinib Dihydrochloride
Strength:
17.7 mg , 26.5 mg
Form: Tablets
Reference Brands: Vanflyta (USA/EU)
View DetailsUsually answered within 48 hours | GMP documents shared before you commit
