By Fineline Cube 
Bayer AG (ETR: BAYN) announced that sevabertinib (trade name HYRNUO) received U.S. FDA approval for adult patients with locally advanced or metastatic non-squamous NSCLC whose tumors harbor HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, following prior systemic therapy, based on the SOHO-01 Phase I/II study demonstrating a 70.5% objective response rate in treatment-naïve patients.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | HYRNUO (sevabertinib) |
| Company | Bayer AG (ETR: BAYN) |
| Agency | U.S. Food and Drug Administration (FDA) |
| Approval Type | Full approval |
| Indication | NSCLC with HER2 TKD mutations post prior systemic therapy |
| Study Basis | Phase I/II SOHO-01 trial |
| Priority Review | Granted May 2025 |
| Next Steps | Commercial launch Q1 2026; companion diagnostic partnership expansion |
Clinical Evidence – SOHO-01 Study
| Cohort | Objective Response Rate (ORR) | Median Duration of Response (DoR) |
|---|---|---|
| HER2-targeted therapy-naïve | 70.5% | 8.7 months |
| Prior HER2-ADC treated | 35.3% | 9.5 months |
| Overall Safety | Favorable profile; consistent with TKI class |
All responses confirmed by independent central review
Drug Profile
- Mechanism: Oral, reversible tyrosine kinase inhibitor (TKI) targeting HER2 TKD mutations
- Innovation: First FDA-approved therapy specifically for HER2 TKD-mutated NSCLC (distinct from HER2 overexpression/amplification)
- Companion Diagnostic: Requires FDA-approved test to identify eligible patients
Market Impact & Outlook
| Metric | Value |
|---|---|
| U.S. HER2 TKD NSCLC Prevalence | ~2% of NSCLC cases (~5,000 patients annually) |
| Existing HER2-ADC Market | Enhertu approved for HER2-mutant NSCLC, but limited penetration in TKD subset |
| Peak Sales Forecast (U.S.) | $450‑600 million by 2030 (assuming 40% share of eligible patients) |
| Pricing | Expected premium to competitor (similar to Tagrisso at ~$18,000/month) |
| Global Expansion | EU filing planned Q2 2026; China bridging study under discussion |
- Competitive Edge: HYRNUO offers oral convenience vs. IV ADCs; 70.5% ORR in naïve patients outperforms historical ADC data
- Reimbursement: FDA approval enables immediate commercial access;医保谈判 expected within 12 months
- Pipeline Extension: Bayer exploring HYRNUO in first-line HER2-mutant NSCLC (Phase III initiation planned 2026)
Forward-Looking Statements
This brief contains forward‑looking statements regarding HYRNUO’s commercial launch, market penetration, and pipeline expansion. Actual results may differ materially due to risks including competitive responses, reimbursement negotiations, and real‑world efficacy data.-Fineline Info & Tech