Sevabertinib Tablets 10 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 10 mg

Reference Brands: Hyrnuo (Bayer)

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.

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.