HongKong:9926

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...

2024-10-16 19:02 2292

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...

2024-10-13 20:27 5003

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...

2024-09-30 13:42 2111

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...

2024-09-16 15:35 5894

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...

2024-09-15 15:10 4323

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...

2024-09-06 08:54 2570

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...

2024-08-29 04:20 3443

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...

2024-08-15 07:30 3258

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...

2024-08-06 12:44 2845

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...

2024-07-29 17:26 3050

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...

2024-06-01 19:10 4854

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...

2024-05-31 02:21 3651

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 ...

2024-04-09 04:53 3110

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 ...

2024-03-06 18:07 3039

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...

2024-02-28 17:27 2793

Akeso Presented Promising Results of Cadonilimab and Lenvatinib in Combination with TACE in uHCC at 2024 ASCO GI

HONG KONG, Jan. 23, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso," "we," or the "Company") today announced that the Company presented the promising phase II results of cadonilimab (a tetravalent PD-1/CTLA-4 bispecific antibody) and Lenvatinib (Len) combined with TACE for the treatment of mi...

2024-01-23 21:00 4235

Akeso to Present at the 42nd Annual J.P. Morgan Healthcare Conference and Share Its Corporate & Innovative Clinical Development Roadmap

HONG KONG, Jan. 8, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso," "we," or the "Company") today announced thatMichelle Xia, Ph.D, the founder, chairwoman, president, and CEO of Akeso, will deliver a keynote speech focusing on the Company's achievements in the development of new bispecific a...

2024-01-08 21:38 2720

Supplemental New Drug Application for Akeso's Cadonilimab (PD-1/CTLA-4) Accepted by NMPA for First-line Treatment of Gastric Cancer

HONG KONG, Jan. 5, 2024 /PRNewswire/ -- Akeso (9926.HK) announced the China National Medical Products Administration (NMPA) has accepted the supplemental new drug application (sNDA) of cadonilimab(开坦尼®, PD-1/CTLA-4 bispecific antibody, AK104) in combination with capecitabine plus oxaliplatin (XEL...

2024-01-05 21:00 6956

Akeso Published Results from CD47 Antibody Ligufalimab in Combination with Azacitidine for Newly Diagnosed Higher-Risk Myelodysplastic Syndrome and Treatment-naïve Acute Myeloid Leukemia at ASH 2023

HONG KONG, Dec. 15, 2023 /PRNewswire/ -- Akeso published two phase Ib clinical results of its innovative CD47 monoclonal antibody ligufalimab (AK117) in combination with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) and treatment-naïve acute myeloid le...

2023-12-15 21:00 2972

Results of three investigator-initiated trials on cadonilimab (PD-1/CTLA-4) for G/GEJC, pMMR/MSS mCRC, and HCC neoadjuvant therapy published at ESMO Asia 2023

First-line therapy for gastric cancer and metastatic colorectal cancer, neoadjuvant therapy for hepatocellular carcinoma HONGKONG, Dec. 5, 2023  /PRNewswire/ -- Akeso (9926.HK) published results from three investigator-initiated trials (IITs) of its bispecific IO drug, cadonilimab (a PD-1/CTLA-4...

2023-12-05 21:00 2661