NCE-1 Intelligence & Market Opportunity

Hyrnuo

Sevabertinib

Anticancer

Oral Tablet

Hyrnuo (sevabertinib) is an oral targeted therapy used to treat adults with locally advanced or metastatic non-squamous non–small cell lung cancer (NSCLC) that has HER2 (ERBB2) tyrosine kinase domain activating mutations. It is prescribed after patients have received at least one prior systemic therapy. Hyrnuo works by blocking HER2-driven tumor growth and is taken twice daily with food.

Approval Date

19-Nov-25

NCE-1 Date

19-Nov-29

NCE Date

19-Nov-30

Commercial snapshot

Market performance & projections

Revenue ($M)

CAGR (%)

Projected sales, 2026–2032 ($M)

Analyst projection, $M per year

2026

2027

2028

2029

2030

2031

119

2032

149

Molecule profile

Details & specifications

Molecule

Sevabertinib

Innovator

BAYER HEALTHCARE PHARMACEUTICALS INC

Dosage Form

Oral Tablet

Strength

10 mg

Therapeutic Category

Anticancer

Usage

To treat locally advanced or metastatic non-squamous non-small cell lung cancer with tumors that have activating HER2 tyrosine kinase domain activating mutations in patients who received a systemic therapy

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Milestones tracked against primary FDA sources and refreshed continuously.

Analyst-built projections

Seven-year sales outlooks modeled by our pharma intelligence team.

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