2024年9月9日三家III期策略梳理
：科伦博泰确定性强，拥有好的合作伙伴；康方生物故事完美，也有美好未来；百利天恒看起来最不安心。总三者都在想如何分割Keytruda市场。
康方生物AK-112 ：共7项，2项开在国外，覆盖NSCLC和BC，2项国内III期已经取得PFS阳性结果，经EGFR-TKI治疗进展NSCLC和EGFR野生一线TPS≥1%NSCLC。
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Protocol/Trial ID
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Trial Title
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Trial Phase
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Sponsor/Collaborator
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Trial Status
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Start Date
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Primary Completion Date
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AK112-309CTR20243164TrialTroveID-532932
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A randomized, controlled, multicenter phase III clinical study of AK112 combined with chemotherapy versus valimumab combined with chemotherapy as the first-line treatment for
advanced biliary tract cancer
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III
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Akeso Biopharma/Kangfang Tiancheng (Guangdong) Pharmaceutical
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Planned
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AK112-301HARMONi-ANCT05184712
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A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who
Have Failed to EGFR-TKI Treatment
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III
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Summit Therapeutics {Summit plc}Akeso Biopharma
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Completed
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2021/12/31
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2025/12/31
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HARMONi-3NCT05899608
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A Randomized, Controlled, Multiregional Phase III Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the
First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (HARMONi-3)
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III
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Summit Therapeutics {Summit plc}
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Open
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2023/10/26
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2027/9/30
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AK112-306NCT05840016
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A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Combined With Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer
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III
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Akeso Biopharma
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Open
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2023/7/28
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2024/12/20
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AK112-303HARMONi-2/AK112-303NCT05499390
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A Randomized Controlled, Multi-center Phase III Clinical Trial of
AK112 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer
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III
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Akeso Biopharma
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Completed
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2022/10/21
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TrialTroveID-418150
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A phase III Clinical Study of AK112 in Patients with Non Small cell Lung Cancer after Treatment failure by Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI)
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III
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Akeso Biopharma
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Open
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|
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TrialTroveID-418075
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A Phase III Study of AK112 for the First-line Treatment of
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