Akeso Announces First Patient Dosed in Phase III Trial of Ivonescimab as Consolidation Therapy for Limited-Stage SCLC After Definitive Radiotherapy
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 deve...
Akeso Announces Approval to Initiate Global Registrational Trial of Cadonilimab (PD-1/CTLA-4) for PD-1 Treatment-Resistant Hepatocellular Carcinoma
HONG KONG, Aug. 4, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225) has been approved to initiate by bothChina's National Medical Products Administration (NMPA) and the ...
Akeso Announces Completion of First Dosing in Phase III Clinical Trial of Ivonescimab (PD-1/VEGF) Combination Therapy for Immunotherapy-Resistant NSCLC
HONG KONG, July 30, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in its pivotal Phase III clinical study (AK112-305/HARMONi-8A) of ivonescimab (PD-1/VEGF bispecific antibody) in combination with docetaxel for the treatment o...
NMPA Accepts sNDA for Ivonescimab in Combination with Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer
HONG KONG, July 28, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with ...
Akeso Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer
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 dev...
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
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 metastati...
Akeso's First Bispecific ADC (Trop2/Nectin4 ADC) Enters Clinical Trials, Strengthening Leadership in 'IO+ADC' 2.0 Strategy
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 bispec...
Subgroup Analysis of Cadonilimab as First-Line Therapy for Advanced Cervical Cancer Reported in an Oral Presentation at ASCO 2025
HONG KONG, June 15, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") presented the subgroup analysis data from the Phase III COMPASSION-16 trial, evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody, in the first-line treatment of advanced, recurrent, or ...
Akeso's PD-1/CTLA-4 Bispecific Antibody Cadonilimab Approved for First-Line Treatment of Cervical Cancer in All-Comer Populations--Third Approved Indication for Cadonilimab
HONG KONG, June 4, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has approved the company's first- in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, for the first-line treatment of persist...
Ivonescimab Receives NMPA Approval for First-Line Treatment of PD-L1-Positive NSCLC, Based on Breakthrough Head to Head Phase III Trial Demonstrating Superior Efficacy Over Pembrolizumab
HONG KONG, April 25, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that its globally first-in-class PD-1/VEGF bispecific antibody, ivonescimab, has received approval from the National Medical Products Administration (NMPA) for its supplementary New D...
Akeso Announces FDA Approval for Penpulimab-kcqx in Two BLA Indications for Comprehensive Treatment of Advanced Nasopharyngeal Carcinoma
HONG KONG, April 24, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabin...
Akeso's Ebdarokimab ( IL - 12/IL - 23 Dual - Targeted Monoclonal Antibody) Approved in China for Moderate - to - Severe Plaque Psoriasis
HONG KONG, April 18, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that ebdarokimab, an investigational monoclonal antibody developed by the company, has received marketing approval from the National Medical Products Administration (NMPA) for the tre...
Akeso's 2024 Results: Strengthening Global Competitiveness and Transforming the Treatment Landscape with Bispecific Antibodies
Key Highlights: * Global first "immuno + anti-vascular" bispecific antibody approved: ivonescimab for EGFR-TKI resistant nsq-NSCLC. Phase III HARMONi study topline data expected mid-2025 (FDA FTD). * ivonescimab outperforms pembrolizumab in Phase III study for first-line PD-L1+ NSCLC: mPFS H...
Akeso's Cadonilimab Combined with Concurrent Chemoradiotherapy Demonstrates Promising Efficacy in Locally Advanced Cervical Cancer: Data Published at the 2025 SGO Annual Meeting
HONG KONG, March 20, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) presented promising phase III safety run-in results from the COMPASSION-18/AK104-305 study, at the 2025 Annual Meeting of the Society of Gynecologic Oncology (SGO). The study evaluates the global first-in-class PD-1/CTLA-4 bispecific ...
Akeso's Penpulimab Receives NMPA Approval for First-Line Treatment of Nasopharyngeal Cancer
HONG KONG, March 16, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) announced that its innovative, self-developed anti-PD-1 monoclonal antibody, penpulimab, has been officially approved by the National Medical Products Administration (NMPA) for the first-line treatment of recurrent or metastatic nasop...
Akeso Announces The Publication of Its Phase III Clinical Trial Results for Ivonescimab in Head-to-Head Comparison with Pembrolizumab in The Lancet
HONG KONG, March 7, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company")is excited to announce that the groundbreaking results of the Phase III clinical study (HARMONi-2/AK112-303) of its first-in-class PD-1/VEGF bispecific antibody, ivonescimab, as a monotherapy compared to pemb...
Akeso Announces Completion of Patient Enrollment in The Phase III Clinical Trial of Cadonilimab for Adjuvant Treatment of High-Risk Recurrent Hepatocellular Carcinoma
HONG KONG, March 5, 2025 /PRNewswire/ -- Akeso, Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce the completion of patient enrollment for its Phase III registrational clinical trial (COMPASSION-22/AK104-306) evaluating cadonilimab, the world's first PD-1/CTLA-4 bispecific antibod...
Akeso Announces First ADC Drug Clinical Trial, Marking a New Era for "IO 2.0 + ADC" Strategy
HONG KONG, Feb. 27, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) announced the first patient has been enrolled in the Phase I clinical trial of AK138 D1 for the treatment of advanced malignancies inAustralia. AK138D1, a self-developed and differentiated HER3-targeting ADC (antibody-drug conjugate)...
Akeso Highlights Collaboration Between Its Partner Summit Therapeutics and Pfizer to Explore Ivonescimab in Combination with Pfizer's ADCs
HONG KONG, Feb. 24, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that its partner on ivonescimab, Summit Therapeutics Inc. (NASDAQ: SMMT) has entered into a clinical trial collaboration with Pfizer Inc. (NYSE: PFE) to evaluate ivonescimab, a novel, investi...
Akeso Enrolled First Patient in The Phase III Clinical Trial of Ivonescimab in Combination with Chemotherapy for First-Line Treatment of Triple-Negative Breast Cancer
HONG KONG, Feb. 20, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced the company has successfully enrolled the first patient in its multicenter, randomized, double-blind Phase III clinical trial of ivonescimab in combination with chemotherapy for first-line tr...
