By Fineline Cube 
Bayer AG (ETR: BAYN) announced that China’s National Medical Products Administration (NMPA) has granted marketing clearance for Hyrnuo (sevabertinib), a tyrosine kinase inhibitor (TKI) indicated for the treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Approval Type | Priority review, full marketing authorization |
| Product | Hyrnuo (sevabertinib) tablets (oral TKI) |
| Indication | HER2-mutant NSCLC after ≥1 prior systemic therapy |
| Previous Designation | Breakthrough Therapy Designation (BTD), January 2026 |
| Approval Date | April 2026 |
| Basis | SOHO-01 Phase I/II clinical trial data |
Clinical Evidence – SOHO-01 Trial Results
The NMPA approval was based on positive results from the open-label, multicenter Phase I/II SOHO-01 trial, which evaluated sevabertinib in patients with advanced NSCLC harboring HER2-activating mutations who had progressed after at least one prior systemic therapy and had not previously received HER2-targeted TKI therapy.
Efficacy by Prior ADC Exposure
| Patient Subgroup | Objective Response Rate (ORR) | Median Duration of Response (mDoR) |
|---|---|---|
| No prior HER2-targeted ADC | 64% | 9.2 months (95% CI: 6.3–15.0; N=52) |
| Prior HER2-targeted ADC | 38% | 7.0 months |
- Safety Profile: Manageable and consistent with previously reported data for HER2-targeted TKIs
- Trial Population: Patients with confirmed HER2-activating mutations in NSCLC
- Study Design: Open-label, multicenter Phase I/II trial across multiple Chinese and international sites
Therapeutic Significance
- Molecule: Sevabertinib (Hyrnuo) – selective HER2 tyrosine kinase inhibitor
- Target Population: NSCLC patients with HER2 (ERBB2) activating mutations – approximately 2-4% of all NSCLC cases globally
- Clinical Need: Limited targeted therapy options for HER2-mutant NSCLC in China, particularly after progression on standard therapies
- Differentiation: First HER2 TKI approved in China specifically for this molecularly-defined NSCLC subgroup
Hyrnuo represents a significant advancement for precision oncology in China, providing a targeted therapeutic option for patients with HER2-mutant NSCLC who have limited treatment alternatives after first-line therapy failure.
Market Impact & Commercial Strategy
- China NSCLC Landscape: Estimated 800,000 new lung cancer cases annually, with NSCLC representing ~85% of cases
- HER2-Mutant Prevalence: Approximately 16,000-32,000 new HER2-mutant NSCLC cases per year in China
- Competitive Position: Addresses unmet need in biomarker-selected population; complements existing EGFR and ALK inhibitors in Bayer’s oncology portfolio
- Pricing & Access: Expected premium pricing with negotiations underway for inclusion in provincial reimbursement formularies
- Launch Strategy: Initial focus on major cancer centers and molecular testing partnerships to identify eligible patients
“This approval marks a significant milestone for precision medicine in China,” said a Bayer Oncology spokesperson. “Hyrnuo provides a much-needed targeted therapy option for NSCLC patients with HER2 mutations, demonstrating our commitment to bringing innovative cancer treatments to Chinese patients.”
Forward-Looking Statements
This brief contains forward-looking statements regarding regulatory approvals, clinical outcomes, market potential, and commercial expectations for Hyrnuo (sevabertinib). Actual results may differ due to risks including market adoption rates, competitive dynamics, pricing negotiations, and healthcare policy changes in China.-Fineline Info & Tech