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Akeso Receives Fifth Breakthrough Therapy Designation from NMPA for Ivonescimab in First-Line Treatment of Advanced Biliary Tract Cancer
Ivonescimab showed a 63.6% objective response rate and 100% disease control rate in advanced biliary tract cancer, supporting its fifth breakthrough therapy designation by China’s NMPA.
- From Hong Kong on Feb. 6, 2026, Akeso announced ivonescimab received its fifth Breakthrough Therapy Designation from the NMPA's CDE for first-line advanced biliary tract cancer.
- The AK112-309 / HARMONi-GI1, randomized Phase III registrational study, is enrolling patients for evaluating ivonescimab plus chemotherapy versus durvalumab plus chemotherapy.
- Study data show ivonescimab plus chemotherapy achieved an Objective Response Rate of 63.6% and a Disease Control Rate of 100%.
- Akeso said the BTD should accelerate ongoing clinical development and the regulatory review process in China, but warned these are forward‑looking statements subject to risks.
- The repeated recognition positions ivonescimab's broad clinical potential as Akeso, Inc. develops over 50 assets with 26 candidates in clinical trials, supported by global‑standard GMP manufacturing and integrated commercialization model.
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Akeso Receives Fifth Breakthrough Therapy Designation from NMPA for Ivonescimab in First-Line Treatment of Advanced Biliary Tract Cancer
HONG KONG, Feb. 5, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) is pleased to announce that ivonescimab, its global first-in-class bispecific antibody targeting PD-1 and VEGF, has been granted its fifth Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE)…
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Total News Sources49
Leaning Left5Leaning Right4Center19Last UpdatedBias Distribution68% Center
Bias Distribution
- 68% of the sources are Center
68% Center
L 18%
C 68%
14%
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