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12.12.2025
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Cadonilimab (PD-1/CTLA-4) Receives FDA Clearance for Global Phase III First-Line Gastric Cancer Trial Versus Nivolumab
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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 will compare cadonilimab plus chemotherapy against che...
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11.12.2025
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Updated Efficacy Data of Ivonescimab Combined with Chemotherapy as First-Line Treatment for TNBC Presented at ESMO IO 2025
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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 for locally advanced unresectable or metastatic tri...
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09.12.2025
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Significant Improvement in Quality of Life Reported in Updated HARMONi-6 Data for Ivonescimab at ESMO Asia
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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 Professor Shun Lu from Shanghai Chest Hospital. The study evaluates ivonescimab (a first-in-class PD-1/...
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20.10.2025
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07.12.2025
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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
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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 by China's National Healthcare Security Administration (NHSA), effective January 1, 2026...
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Swarmalpha i/o · The Event Futures Prediction X
20.10.2025
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17.11.2025
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Akeso's Bispecific Antibody Targeting Aβ and BBB-Expressed Receptor Approved for Alzheimer's Disease Clinical Trials in China
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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 initiate clinical trials...
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10.11.2025
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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
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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 company's first-in-cl...
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07.11.2025
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Ivonescimab HARMONi-A Study Final OS Analysis Results Presented at SITC 2025 with OS HR=0.74
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The HARMONi-A study is the first Phase III trial of an immunotherapy for EGFR-TKI-resistant, EGFR-mutated non-squamous NSCLC to show statistically significant and clinically meaningful improvements in both progression-free survival (PFS) and overall survival (OS)
With a median follow-up of 32.5...
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07.11.2025
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Akeso Unveils Promising Preclinical Data for IL-1RAP Targeting Antibody (AK135) at SITC 2025
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HONG KONG, Nov. 7, 2025 /PRNewswire/ -- Akeso, Inc. (HKEX: 9926.HK) published the preclinical research data for its novel antagonistic monoclonal antibody targeting IL-1RAP, AK135, at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) held in National Harbor, Maryland.
The r...
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03.11.2025
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Akeso's Ivonescimab Secures Fourth Breakthrough Therapy Designation in China for First-Line Treatment of Triple-Negative Breast Cancer
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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 t...
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30.10.2025
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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
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HONG KONG, Oct. 30, 2025 /PRNewswire/ -- Akeso (9926.HK) is excited to announce that the significant results from the final overall survival analysis of the Phase III HARMONi-A study, which evaluates the first-in-class bispecific antibody ivonescimab (PD-1/VEGF bispecific antibody) combined with chemotherapy for...
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19.10.2025
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Significant OS Benefit with Cadonilimab in First-Line Advanced Gastric Cancer: Final Analysis of COMPASSION-15 Presented at ESMO 2025
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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, Akeso's first-in-cl...
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19.10.2025
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HARMONi-6 Data: mPFS 11.14 Months (HR=0.6, P<0.0001) Simultaneously Released at ESMO and in The Lancet
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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 therap...
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20.10.2025
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16.10.2025
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HARMONi-6 Phase III Study of Ivonescimab Accepted by The Lancet and Selected for ESMO 2025 LBA Presentation
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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 bispecific antibody...
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23.09.2025
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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
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HONG KONG, Sept. 22, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) is excited to announce that the Late-Breaking Abstract (LBA) from the registrational Phase III clinical study (AK112-306/HARMONi-6 study) of ivonescimab, a globally first-in-class bispecific antibody targeting PD-1 and VEGF, will be presented at the 2025 European Society for Medical O...
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16.09.2025
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Akeso's Ligufalimab (CD47 mAb) Receives FDA Orphan Drug Designation for Acute Myeloid Leukemia (AML)
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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 (AML).
The Orphan Drug Designation is a program esta...
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15.09.2025
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Akeso Announces First Patient Dose in Global Registrational Trial of Cadonilimab (PD-1/CTLA-4) for PD-1 Treatment-Resistant Hepatocellular Carcinoma
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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 PD-1/CTLA-4 bispecific antibody, in combination with...
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10.09.2025
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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
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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 2025 World Conference on Lung Cancer (WCLC). This ma...
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07.09.2025
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Ivonescimab Plus Chemotherapy Demonstrates Consistent Global Benefit: HARMONi Data Update Shows OS HR=0.78, Nominal P=0.0332
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The overall survival (OS) hazard ratio (HR) in the HARMONi trial was 0.78, with a nominal p-value of 0.0332In the North American patients, the OS HR was 0.70The HARMONi trial has already demonstrated clinically meaningful and statistically significant progression-free survival (PFS) outcomesIn the HARMONi trial, clinical endpoint benefits, includ...
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02.09.2025
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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
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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 therapy, for the first-line treatment of advanced bili...
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26.08.2025
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Akeso's 2025 Interim Results: Commercial Sales Reach New All-Time Highs
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IO 2.0 + ADC 2.0 Strategy Builds a "Next-Generation" Platform with Global Competitive Edge
Key Highlights:
Final analysis of HARMONi-A Study: Ivonescimab met the overall survival (OS) endpoint, demonstrating a statistically significant and clinically meaningful OS benefitFirst international Phase III HARMONi study of Ivonescimab: High concordance...
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25.08.2025
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Akeso Reports Phase 3 Trials Show Positive Results: Gumokimab (IL-17) for Ankylosing Spondylitis and Manfidokimab (IL-4Rα) for Atopic Dermatitis Achieve Primary Endpoints
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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 successfully met all primary efficacy endpoints, in...
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20.08.2025
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First Patient Dosed in Pivotal Phase III Trial of Cadonilimab (PD-1/CTLA-4) for Perioperative Treatment of Resectable Gastric Cancer
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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 by Akeso, in combination with chemotherapy for the p...
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11.08.2025
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Akeso Announces First Patient Dosed in Phase III Trial of Ivonescimab as Consolidation Therapy for Limited-Stage SCLC After Definitive Radiotherapy
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HONG KONG, Aug. 10, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its multicenter, randomized, double-blind Phase III study (AK112-311/HARMONi-9), evaluating ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by Akeso, in small cell lung cancer (SCLC). T...
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24.07.2025
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Akeso Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer
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HONG KONG, July 23, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the first patient has been enrolled in the pivotal/registration Phase III clinical trial (AK112-310/HARMONi-GI2) of ivonescimab, a first-in-class PD-1/VEGF bispecific antibody developed by the company. The trial is investigating i...
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16.07.2025
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Akeso Announces First Patient Enrolled in the Phase III Trial（AK112-312/HARMONi-GI6）of Ivonescimab for First-Line Treatment of Advanced Metastatic Colorectal Cancer
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HONG KONG, July 15, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the first patient has been successfully enrolled in the registration Phase III clinical trial (AK112-312/HARMONi-GI6) of ivonescimab in first-line treatment for advanced metastatic colorectal cancer (mCRC).
This randomized, contr...
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03.07.2025
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Akeso's First Bispecific ADC (Trop2/Nectin4 ADC) Enters Clinical Trials, Strengthening Leadership in 'IO+ADC' 2.0 Strategy
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HONG KONG, July 3, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") has announced the successful enrollment of the first patient in its Phase Ia clinical trial for AK146D1, a bispecific Antibody-Drug Conjugate (ADC) targeting Trop2 and Nectin4. AK146D1 is Akeso's first bispecific ADC to enter clinical trials.
AK146D1 has rec...
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