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Alphamab Oncology says China NMPA accepts Anbenitamab NDA for first-line HER2+ advanced breast cancer

PUBT·08/18/2026 10:01:34
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Alphamab Oncology says China NMPA accepts Anbenitamab NDA for first-line HER2+ advanced breast cancer
  • China’s NMPA accepted an NDA for anbenitamab (KN026) plus albumin-bound docetaxel HB1801 in first-line HER2-positive advanced breast cancer.
  • Application entered priority review; regimen previously received NMPA breakthrough therapy designation.
  • NDA backed by Phase III KN026-003/Healer, showing superior progression-free survival versus trastuzumab, pertuzumab, docetaxel standard regimen.
  • Anbenitamab was co-developed with CSPC Pharma unit JMT-Bio; JMT-Bio holds exclusive China mainland breast, gastric cancer rights.


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-20260818-12288837), on August 18, 2026, and is solely responsible for the information contained therein.