Ivonescimab's Updated Label Shows Positive Dual Results in PFS and OS from HARMONi-A Study
HONG KONG, Jan. 6, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) announced that the National Medical Products Administration has approved a significant label update inChina for its internally developed, first-in-class PD-1/VEGF bispecific antibody, ivonescimab. The updated label incorporates final a...
Cadonilimab (PD-1/CTLA-4) Receives FDA Clearance for Global Phase III First-Line Gastric Cancer Trial Versus Nivolumab
HONG KONG, Dec. 11, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced FDA approval to initiate COMPASSION-37/AK104-311 trial, a global multicenter Phase III trial in gastric cancer evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody. The study wi...
Updated Efficacy Data of Ivonescimab Combined with Chemotherapy as First-Line Treatment for TNBC Presented at ESMO IO 2025
HONG KONG, Dec. 10, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced the presentation of a Phase II clinical study that included a longer-term efficacy data evaluating ivonescimab (a PD-1/VEGF bispecific antibody) combined with chemotherapy as a first-line treatment...
Phase II Data of Cadonilimab Regimen as Neoadjuvant Therapy for Resectable Gastric Cancer Presented at ESMO Asia 2025
HONG KONG, Dec. 9, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that data from the Phase II study (COMPASSION-25) for its first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, in combination with SOX regimen (oxaliplatin + tegafur/gimeracil/oteracil) as n...
Significant Improvement in Quality of Life Reported in Updated HARMONi-6 Data for Ivonescimab at ESMO Asia
HONG KONG, Dec. 8, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that at the 2025 ESMO Asia Congress, updated results from the pivotal Phase III HARMONi-6 study (AK112-306) were shared in an oral presentation by ProfessorShun Lu from Shanghai Chest Hospital. The ...
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
HONG KONG, Dec. 7, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced the successful inclusion of all five of the Company's self-developed innovative drugs into the updated National Reimbursement Drug List (NRDL) for 2025, released byChina's National Healthcare Securi...
Akeso's Bispecific Antibody Targeting Aβ and BBB-Expressed Receptor Approved for Alzheimer's Disease Clinical Trials in China
HONG KONG, Nov. 16, 2025 /PRNewswire/ -- Akeso, Inc. (HKEX: 9926.HK) announced that its AK152, a novel bispecific antibody targeting both amyloid-beta (Aβ) and blood-brain barrier (BBB) expressed receptor, has been granted approval by the National Medical Products Administration (NMPA) to initiat...
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
HONG KONG, Nov. 10, 2025 /PRNewswire/ -- Akeso, Inc. (HKEX: 9926. HK) is pleased to announce that the first patient has been dosed in a Phase I clinical trial evaluating the personalized mRNA vaccine AK154. This trial is investigating AK154 both as a monotherapy and as a combination with the com...
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 Desi...
Significant OS Benefit with Cadonilimab in First-Line Advanced Gastric Cancer: Final Analysis of COMPASSION-15 Presented at ESMO 2025
HONG KONG, Oct. 19, 2025 /PRNewswire/ -- On October 19, 2025, Akeso (9926.HK) announced the final analysis results from the COMPASSION-15/AK104-302 study at the 2025 European Society of Medical Oncology Congress (ESMO 2025) . COMPASSION-15 is a Phase III clinical trial evaluating cadonilimab, Ak...
HARMONi-6 Data: mPFS 11.14 Months (HR=0.6, P<0.0001) Simultaneously Released at ESMO and in The Lancet
* Ivonescimab plus chemotherapy demonstrated a median PFS of 11.14 months, PFS HR=0.60, P < 0.0001. * The absolute difference in median PFS between the two groups was 4.24 months (ΔPFS = 4.24 months), indicating significantly prolonged progression-free survival with ivonescimab combination th...
HARMONi-6 Phase III Study of Ivonescimab Accepted by The Lancet and Selected for ESMO 2025 LBA Presentation
HONG KONG, Oct. 16, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) today announced that the groundbreaking results from the registrational Phase III AK112-306/HARMONi-6 study of ivonescimab have been accepted for publication in The Lancet. The study evaluated ivonescimab, a first-in-class PD-1/VEGF b...
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
HONG KONG, Sept. 22, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) has announced that the first patient has been dosed in its registrational Phase II study (AK130-202), evaluating AK130, a fully independently developed TIGIT/TGF-β bifunctional antibody fusion protein, in combination with ivonescimab ...
Akeso's Ligufalimab (CD47 mAb) Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia (AML)
HONG KONG, Sept. 15, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) today announced that its proprietary next-generation humanized IgG4 monoclonal antibody targeting CD47, ligufalimab (AK117), has been granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of acute myeloid leukemia (A...
Akeso Announces First Patient Dose in Global Registrational Trial of Cadonilimab (PD-1/CTLA-4) for PD-1 Treatment-Resistant Hepatocellular Carcinoma
HONG KONG, Sept. 15, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225). The trial will evaluate cadonilimab, Akeso's first-in-class P...
Cadonilimab(PD-1/CTLA-4) plus Pulocimab (VEGFR-2) Combination Therapy Shows Promising Results in IO-Resistant Non-Small Cell Lung Cancer in Oral Presentation at the 2025 WCLC
HONG KONG, Sept. 9, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) announced that data from a Phase Ib/II clinical study evaluating the combination of cadonilimab and pulocimab (an anti-VEGFR-2 antibody) in patients with immunotherapy (IO)-resistant NSCLC were presented in a Mini Oral session at the ...
Ivonescimab Plus Chemotherapy Demonstrates Consistent Global Benefit: HARMONi Data Update Shows OS HR=0.78, Nominal P=0.0332
* The overall survival (OS) hazard ratio (HR) in the HARMONi trial was 0.78, with a nominal p-value of 0.0332 * In the North American patients, the OS HR was 0.70 * The HARMONi trial has already demonstrated clinically meaningful and statistically significant progression-free survival (PFS) ...
Akeso Announces Completion of Patient Enrollment in Phase III Clinical Trial for Ivonescimab as First-Line Treatment for Biliary Tract Cancer Compared to PD-L1 Therapy
HONG KONG, Sept. 2, 2025 /PRNewswire/ -- Akeso (9926.HK) has recently announced the completion of patient enrollment in its Phase III, multicenter, randomized, controlled, registrational study evaluating ivonescimab, in combination with standard therapy, against durvalumab (PD-L1) combination the...
Akeso Reports Phase 3 Trials Show Positive Results: Gumokimab (IL-17) for Ankylosing Spondylitis and Manfidokimab (IL-4Rα) for Atopic Dermatitis Achieve Primary Endpoints
HONG KONG, Aug. 25, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) ("Akeso" or "the Company") today announced positive results from its Phase 3 clinical trial of gumokimab (AK111), a novel, fully human anti-IL-17A monoclonal antibody, for the treatment of active ankylosing spondylitis (AS). The study ...
First Patient Dosed in Pivotal Phase III Trial of Cadonilimab (PD-1/CTLA-4) for Perioperative Treatment of Resectable Gastric Cancer
HONG KONG, Aug. 20, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced the enrollment and dosing of the first patient in the pivotal Phase III clinical trial (AK104-310/COMPASSION-33) evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody developed b...
