---
title: "CSPC says China regulator grants breakthrough therapy designation for HER2-positive breast cancer combo"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/292612215.md"
description: "CSPC Pharmaceutical Group received China NMPA breakthrough therapy designation for HB1801 albumin-bound docetaxel combined with KN026 anbenitamab in first-line advanced HER2-positive breast cancer. KN026 is co-developed by CSPC's Shanghai JMT-BIO and Jiangsu Alphamab. The Phase III Healer study met its primary PFS endpoint, surpassing the THP standard regimen, with a New Drug Application filing planned soon."
datetime: "2026-07-14T11:01:44.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/292612215.md)
  - [en](https://longbridge.com/en/news/292612215.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/292612215.md)
generator: "portal-rs"
---

# CSPC says China regulator grants breakthrough therapy designation for HER2-positive breast cancer combo

-   CSPC won China NMPA breakthrough therapy designation for HB1801 albumin-bound docetaxel with KN026 anbenitamab in first-line advanced HER2-positive breast cancer. \* KN026 is co-developed by CSPC unit Shanghai JMT-BIO with Jiangsu Alphamab Biopharmaceuticals. \* Phase III Healer study met its primary PFS endpoint, beating the THP standard regimen; NDA filing planned soon. 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. CSPC Pharmaceutical Group Ltd. published the original content used to generate this news brief via IIS, the regulatory disclosure system operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260714-12244090), on July 14, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

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