Akeso's Penpulimab Combination Therapy for First-line Treatment of Hepatocellular Carcinoma Accepted by NMPA
HONG KONG, Nov. 22, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the National Medical Products Administration (NMPA) of China has accepted its supplemental new drug application (sNDA) for penpulimab, a differentiated PD-1 monoclonal antibody, in combination...
Akeso Biopharma to Attend Jefferies London Healthcare Conference and Morgan Stanley 23rd Asia Pacific Summit
HONG KONG, Nov. 18, 2024 /PRNewswire/ -- Akeso Biopharma (9926. HK) ("Akeso" or the "Company") is pleased to announce thatDr. Michelle Xia, the company's founder, chairwoman, president, and CEO, will attend Morgan Stanley's 23rd Asia Pacific Summit.Dr. Bing C. Wang, the company's chief financial ...
Akeso Published Mechanism of Action for CLDN18.2/CD47 Bispecific Antibody AK132 for the First Time at SITC Annual Meeting
HONG KONG, Nov. 7, 2024 /PRNewswire/ -- At the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024), held inHouston, USA, from November 6 - 10, Akeso Biopharma (9926. HK) presented the mechanism of action (MOA) research findings of its innovative bispecific antibody, AK132, ...
Akeso Announces First Patient Enrollment in Phase 3 Trial of Ivonescimab Combination as First-Line Therapy for Biliary Tract Tumors, Compared to Durvalumab
HONG KONG, Oct. 31, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) is pleased to announce the successful enrollment of the first patient in the HARMONi-GI-01/AK112-309 study, a randomized, controlled, multicenter Phase III registration study for biliary track tumor. This trial is designed to comp...
Akeso Announces First Patient Enrollment in Phase 3 Trial of Ivonescimab Combined with Ligufalimab (CD47) for First-Line Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC), Compared to Pembrolizumab
HONG KONG, Oct. 30, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) is pleased to announce the enrollment of the first patient in its randomized, controlled, multicenter Phase III clinical study (AK117-302) for head and neck squamous cell carcinoma. This trial evaluates the innovative PD-1/VEGF bi...
IGCS Late Breaking Abstract and The Lancet: Akeso Published Positive PFS and OS Results from Phase 3 First-Line Study of Cadonilimab in Cervical Cancer
HONG KONG, Oct. 16, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) (" Akeso", the "Company" ) announced positive results in progression-free survival (PFS) and overall survival (OS) from its Phase 3 clinical study (COMPASSION-16/AK104-303). This study evaluated the efficacy of its independently...
Akeso Secures $250 Million USD to Propel Global Expansion of Its Innovative Drug Pipeline
Expediting International Clinical Trials for Pivotal Products Key Participants Include International Long-Term and Healthcare Funds HONG KONG, Oct. 13, 2024 /PRNewswire/ -- Akeso Biopharma (9926. HK) ("Akeso", the "Company" ) announced that it has successfully raised approximately$250 million US...
Akeso's Cadonilimab Receives Second Indication Approval from NMPA for First-Line Treatment of Gastric/GEJ Cancer in All-Comers Population
HONG KONG, Sept. 30, 2024 /PRNewswire/ -- September 30, 2024, Akeso (9926. HK) announced that its internally developed PD-1/CTLA-4 bispecific antibody, cadonilimab, has received approval from the National Medical Products Administration (NMPA) for a new indication: cadonilimab in combination with...
Akeso's Ivonescimab plus Chemo in First-Line Triple-negative Breast Cancer Showed Promising Preliminary Efficacy and Good Safety at ESMO 2024
HONG KONG, Sept. 16, 2024 /PRNewswire/ -- At the 2024 European Society for Medical Oncology (ESMO) Conference, Akeso (9926.HK) published the phase 2 results from its ivonescimab in combination with chemotherapy as a first-line (1L) treatment for triple-negative breast cancer (TNBC). The prelimina...
Akeso Published Ivonescimab plus Ligufalimab as First-Line Treatment for PD-L1-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma at ESMO 2024
Head-to-Head Phase 3 Trial Compared to Pembrolizumab Initiated HONG KONG, Sept. 15, 2024 /PRNewswire/ -- At the 2024 European Society for Medical Oncology (ESMO) Conference, Akeso released the Phase 2 clinical results of its internally developed PD-1/VEGF bispecific antibody, ivonescimab, with or...
Akeso to Present Data from 13 Clinical Studies at ESMO 2024, Featuring its Internally Developed Cadonilimab, Ivonescimab, Ligufalimab, and other I/O Antibodies
HONG KONG, Sept. 5, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) will showcase promising results from 13 clinical studies on its internally developed PD-1/CTLA-4 bispecific antibody cadonilimab, PD-1/VEGF bispecific antibody ivonescimab, next-generation CD47 monoclonal antibody ligufalimab, and co...
Akeso's 2024 First Half Interim Results: Expanding Global Lead in IO Bispecific Antibodies, Advancing New Therapies, and Accelerating Commercialization
* Approval of ivonescimab for 2L+ EGFRm NSCL; HARMONi-A is the only phase III study that demonstrates significant benefit across all subgroups for PFS, and is also the only study to achieve the primary endpoint while showing a positive trend in OS benefit; HARMONi-A study presented in an oral p...
Ivonescimab (PD-1/VEGF) Received Priority Review from China's NMPA for First-Line Treatment of PD-L1 Positive NSCLC
The Second Indication of Ivonescimab in NSCLC 2L+ EGFRm NSCLC Already Approved in May 2024 HONG KONG, Aug. 14, 2024 /PRNewswire/ -- Akeso, Inc. (HKEX: 9926.HK) ("Akeso,") today announced that the National Center for Drug Evaluation of the State Drug Administration ofthe People's Republic of China...
First Patient Enrolled in the US Phase 2 Combination Therapy of Akeso's Ligufalimab with Azacitidine for Myelodysplastic Syndrome
HONG KONG, Aug. 6, 2024 /PRNewswire/ -- Akeso has announced the completion of the first patient enrollment in the US for the phase II clinical trial of its innovative CD47 monoclonal antibody, ligufalimab (AK117), in combination with azacitidine for patients with newly diagnosed higher-risk myelo...
Akeso's sBLA for Ivonescimab in 1L Treatment of PD-L1 Positive NSCLC Accepted by NMPA
HONG KONG, July 29, 2024 /PRNewswire/ -- Akeso (9926.HK) is delighted to announce that the supplemental biologics license application (sBLA) for its independently developed, world's first-in-class PD-1/VEGF bispecific antibody drug, 依达方® (generic name: ivonescimab Injection), as a monotherapy for...
Ivonescimab in Combination with Chemotherapy Approved in China by NMPA for 2L+ EGFRm NSCLC based on HARMONi-A Clinical Trial: Positive Trend Observed in Overall Survival towards Ivonescimab Plus Chemotherapy
Separate & Distinct from HARMONi-2 Announcement, HARMONi-A Showed Clinically Meaningful and Statistically Significant Benefit: PFS Hazard Ratio of 0.46 For Subset of Patients Previously Receiving 3rd Generation EGFR-TKI: PFS Hazard Ratio of 0.48 5.6% Treatment Discontinuation of Ivonescimab due...
Ivonescimab Monotherapy Decisively Beats Pembrolizumab Monotherapy Head-to-Head, Achieves Statistically Significant Superiority in PFS in First-Line Treatment of Patients with PD-L1 Positive NSCLC
* Monotherapy Ivonescimab Achieved Clinically Meaningful PFS Benefit in HARMONi-2 Trial Conducted by Akeso * PFS Improvement Was Observed Broadly in Patients Across Subgroups, including PD-L1 Low and PD-L1 High Expressing Tumors, Squamous and Non-Squamous Histologies * Full Data Set to be P...
Oral report | The positive interim analysis results from the Phase III clinical study of Akeso's Cadonilimab (PD-1/CTLA-4 BsAb) plus chemotherapy as first-line treatment for advanced gastric cancer presented at 2024 AACR
SAN DIEGO, April 8, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) today announced thatthe positive interim analysis results from Phase III clinical study of Cadonilimab (PD-1/CTLA-4 BsAb)combined with XELOX (capecitabine plus oxaliplatin) as first-line treatment for unresectable locally advanced or ...
Akeso Announced the First Patient Dosed in Phase III Trial of Cadonilimab(PD-1/CTLA-4) Combined with Chemotherapy versus Tislelizumab Combined with Chemotherapy in First-line Treatment of PD-L1 negative NSCLC
HONG KONG, March 6, 2024 /PRNewswire/ -- Akeso Inc. ("Akeso", 9926. HK) announced the enrollment of the first patient in the registrational Phase III clinical study comparingCadonilimab (PD-1/CTLA-4 bispecific antibody) combined with chemotherapy versus Tislelizumab (PD-1 antibody) combined with ...
The promising results of a phase II clinical study for Akeso's Cadonilimab (PD-1/CTLA-4) combined standard treatment for first-line treatment of R/M cervical cancer has been published in Clinical Cancer Research
HONG KONG, Feb. 28, 2024 /PRNewswire/ -- Akeso (9926.HK) announced that the results of a phase II clinical trial for PD-1/CTLA-4 bispecific antibody（cadonilimab）combined with standard treatment (chemotherapy +/- bevacizumab) as first-line treatment for recurrent/metastatic cervical cancer had be...
