Press Releases Akeso, Inc.

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KYG0146B1032

Biotechnology & Medical Research

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06/02	Akeso, Inc. Receives Fifth Breakthrough Therapy Designation from NMPA for Ivonescimab in First-Line Treatment of Advanced Biliary Tract Cancer	CI
03/02	Akeso granted exclusive commercialization rights for ebronucimab injection to Jumpcan Pharmaceutical	RE

Press Releases

06/02	Akeso Receives Fifth Breakthrough Therapy Designation from NMPA for Ivonescimab in First-Line Treatment of Advanced Biliary Tract Cancer	PR
30/01	Summit Therapeutics Announces U.S. FDA Acceptance of Biologics License Application Seeking Approval for Ivonescimab in Combination with Chemotherapy in Treatment of Patients with EGFRm NSCLC Post-TKI Therapy	AQ
29/01	Ivonescimab Included in FirstWord Pharma's "The Drugs That Will Shape 2026"	PR
19/01	Akeso Announces NMPA Acceptance of Second NDA for Gumokimab (IL-17A Inhibitor) in Active Ankylosing Spondylitis	PR
14/01	Head-to-Head Real-World Data: Cadonilimab Outperforms PD-1 Inhibitors in First-Line PD-L1-Low Gastric Cancer	PR
07/01	Ivonescimab's Updated Label Shows Positive Dual Results in PFS and OS from HARMONi-A Study	PR
12/12	Cadonilimab (PD-1/CTLA-4) Receives FDA Clearance for Global Phase III First-Line Gastric Cancer Trial Versus Nivolumab	PR
11/12	Updated Efficacy Data of Ivonescimab Combined with Chemotherapy as First-Line Treatment for TNBC Presented at ESMO IO 2025	PR
09/12	Phase II Data of Cadonilimab Regimen as Neoadjuvant Therapy for Resectable Gastric Cancer Presented at ESMO Asia 2025	PR
09/12	Significant Improvement in Quality of Life Reported in Updated HARMONi-6 Data for Ivonescimab at ESMO Asia	PR
07/12	All Approved Indications of Five Akeso's Innovative Drugs Included in China's Latest NRDL: Featuring Two First-in-Class Bispecifics with New First-Line Indications and Three Newly Negotiated Drugs	PR
17/11	Akeso's Bispecific Antibody Targeting Aβ and BBB-Expressed Receptor Approved for Alzheimer's Disease Clinical Trials in China	PR
10/11	Akeso Announces First Patient Dosed in Phase I Trial of Personalized mRNA Vaccine AK154 as Monotherapy or in Combination with Cadonilimab or Ivonescimab for Adjuvant Treatment of Pancreatic Cancer	PR
07/11	Akeso Unveils Promising Preclinical Data for IL-1RAP Targeting Antibody (AK135) at SITC 2025	PR
07/11	Ivonescimab HARMONi-A Study Final OS Analysis Results Presented at SITC 2025 with OS HR=0.74	PR
03/11	Overall Survival Data from HARMONi-A, Featuring Ivonescimab in Combination with Chemotherapy vs. Chemotherapy in 2L+ Treatment of Patients with EGFRm NSCLC in China, to be Showcased at SITC 2025	AQ
03/11	Akeso's Ivonescimab Secures Fourth Breakthrough Therapy Designation in China for First-Line Treatment of Triple-Negative Breast Cancer	PR
30/25/30	First Dual-Positive Immunotherapy with PFS and OS Benefit in EGFR+ NSCLC After EGFR-TKI Progression: Ivonescimab Final OS Analysis from HARMONi-A to Be Presented at SITC 2025	PR
19/25/19	Significant OS Benefit with Cadonilimab in First-Line Advanced Gastric Cancer: Final Analysis of COMPASSION-15 Presented at ESMO 2025	PR
19/25/19	HARMONi-6 Data: mPFS 11.14 Months (HR=0.6, P	PR
16/25/16	Summit Therapeutics to Host ESMO Data Update Third Quarter Earnings Call on October 20 2025	AQ
16/25/16	HARMONi-6 Phase III Study of Ivonescimab Accepted by The Lancet and Selected for ESMO 2025 LBA Presentation	PR
23/25/23	Ivonescimab HARMONi-6 Results Selected for ESMO 2025 LBA; Final Phase III Results of Cadonilimab as First-Line Therapy for Advanced Gastric Cancer to Be Published as an Oral Presentation	PR
22/25/22	Akeso Announces First Patient Dosed in Registrational Phase II Study of TIGIT/TGF-β Bifunctional Antibody Fusion Protein AK130 Combined with Ivonescimab for Advanced Pancreatic Cancer	PR
16/25/16	Akeso's Ligufalimab (CD47 mAb) Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia (AML)	PR

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Press Releases Akeso, Inc.

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