---
title: "Bayer says Japan approves sevabertinib for HER2-mutant NSCLC"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/296745277.md"
description: "Japan's MHLW has approved Bayer's Hyrnuo (sevabertinib) for HER2-mutant unresectable advanced or recurrent non-small cell lung cancer (NSCLC). This marks Japan's first targeted therapy for this indication, with a label allowing use across all treatment lines, including first-line. The approval is based on SOHO-01 data showing a 75.3% overall response rate and 13.5-month median progression-free survival in previously untreated patients."
datetime: "2026-08-24T06:34:47.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/296745277.md)
  - [en](https://longbridge.com/en/news/296745277.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/296745277.md)
generator: "portal-rs"
---

# Bayer says Japan approves sevabertinib for HER2-mutant NSCLC

-   Japan’s MHLW cleared Bayer’s Hyrnuo (sevabertinib) for HER2 (ERBB2) mutation-positive unresectable advanced or recurrent NSCLC. \* Label allows use across all treatment lines, including first-line, making it Japan’s first targeted therapy for this indication. \* Approval relied on SOHO-01 data showing 75.3% ORR in previously untreated advanced or recurrent patients; median PFS 13.5 months. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Bayer AG published the original content used to generate this news brief on August 24, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT) Original Document: here

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---
> **Disclaimer: This article is for reference only and does not constitute any investment advice.**