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Akeso's Ivonescimab Secures Fourth Breakthrough Therapy Designation in China for First-Line Treatment of Triple-Negative Breast Cancer

  • Akeso's Ivonescimab has received Breakthrough Therapy Designation from the Center for Drug Evaluation for treating triple-negative breast cancer, marking the fourth designation it has received.
  • This designation signifies Ivonescimab's substantial clinical benefit across multiple major cancer types, according to Akeso.
  • Ivonescimab is part of 14 Phase III clinical trials worldwide, enhancing its development and approval prospects.
  • It is recognized as the world's first bispecific antibody utilizing a synergistic 'immunotherapy plus anti-angiogenesis' mechanism.
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Akeso's Ivonescimab Secures Fourth Breakthrough Therapy Designation in China for First-Line Treatment of Triple-Negative Breast Cancer

HONG KONG, Nov. 2, 2025 /PRNewswire/ -- Akeso (9926.HK) announced that its first-in-class bispecific antibody, ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for first-line treatment of triple-negative breast cancer (TNBC) has been granted Breakthrough Therapy Designation (BTD) by the…

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PR Newswire broke the news in United States on Monday, November 3, 2025.
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