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Alphamab Oncology says China regulator grants breakthrough tag for anbenitamab in first-line HER2+ advanced breast cancer

PUBT·07/14/2026 11:02:07
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Alphamab Oncology says China regulator grants breakthrough tag for anbenitamab in first-line HER2+ advanced breast cancer
  • Alphamab Oncology’s anti-HER2 bispecific antibody anbenitamab (KN026) won NMPA breakthrough therapy status for first-line unresectable or metastatic HER2+ breast cancer.
  • Designation covers anbenitamab combined with albumin-bound docetaxel HB1801, co-developed with CSPC’s JMT-Bio.
  • Phase III KN026-003 met its primary endpoint of progression-free survival in June 2026, beating the current standard THP regimen.
  • New drug application planned for the breast cancer indication in the near term.
  • Anbenitamab previously received NMPA breakthrough status for HER2+ gastric cancer, gaining NMPA marketing clearance in May 2026 for later-line HER2+ gastric/GEJ cancer.


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. Alphamab Oncology 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-20260714-12244088), on July 14, 2026, and is solely responsible for the information contained therein.