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CTTQ Akesobio
Akeso Pharma
Marketing approval: In August 2021, Penpulimab was officially approved for marketing by the National Medical Products Administration (NMPA) for the treatment of relapsed or refractoryclassical Hodgkin’s lymphoma (r/r cHL) after at least second-line systemic chemotherapy treatment.
NDA: In July 2021, the marketing application for Penpulimab plus chemotherapy in the first-line treatment of locally advanced or Metastatic squamous non-small cell lung cancer was accepted by the NMPA.
BLA: In May 2021, Akeso submitted a Biologics License Application (BLA) for Penpulimab to the Food and Drug Administration of the United States (FDA) for the third-line treatment of Metastatic nasopharyngeal carcinoma.
NDA：In?August 2021, NDA of Penpulimab for third-line treatment of Metastatic nasopharyngeal carcinoma was submitted and was accepted by the NMPA.
Marketing approval: In January 2023, Penpulimab was officially approved for first-line treatment of locally advanced or Metastatic sq-NSCLC.
Marketing approval: Penpulimab was officially approved for?third-line treatment of Metastatic nasopharyngeal carcinoma.
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Akeso News
Monthly News
2024-09-30
Akeso's Cadonilimab Receives Second Indication Approval from NMPA for First-Line Treatment of Gastric/GEJ Cancer in All-Comers Population
2024-09-30
Akeso’s Ebronucimab（PCSK9) Approved for Two Indications for the Treatment of Hypercholesterolemia in China
2024-09-18
ESMO 2024 | Akeso Published First-Ever Efficacy Data for PD-1/VEGF Bispecific Antibody Ivonescimab with or without CD47 Antibody plus FOLFOXIRI for mCRC
2024-09-18
ESMO 2024 | Akeso’s Ivonescimab plus Chemo in First-Line Triple-negative Breast Cancer Showed Promising Preliminary Efficacy and Good Safety
2024-09-18
ESMO 2024 | Akeso Published Ivonescimab plus Ligufalimab as First-Line Treatment for PD-L1–Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
2024-09-09
WCLC 2024 | Perioperative Ivonescimab (PD-1/VEGF) for NSCLC Demonstrated Clinically Significant Phase II Results, Presented in Oral Session
2024-09-08
WCLC 2024 | Akeso's Ivonescimab Head-to-Head Phase III Data Against Pembrolizumab Unveiled
2024-09-06
Akeso to Present Data from 13 Clinical Studies at ESMO 2024, Featuring its Internally Developed Cadonilimab, Ivonescimab, Ligufalimab, and other I/O Antibodies
2024-08-29
Akeso's 2024 First Half Interim Results: Expanding Global Lead in IO Bispecific Antibodies, Advancing New Therapies, and Accelerating Commercialization
2024-08-15
Ivonescimab (PD-1/VEGF) Received Priority Review from China’s NMPA for First-Line Treatment of PD-L1 Positive NSCLC
2024-08-10
Two Ivonescimab (PD-1/VEGF) Results including Phase 3 Monotherapy versus Pembrolizumab Monotherapy in First-Line Treatment for PD-L1 Positive NSCLC to Be Presented at WCLC 2024
2024-08-06
First Patient Enrolled in the US Phase 2 Combination Therapy of Akeso's Ligufalimab with Azacitidine for Myelodysplastic Syndrome
2024-07-29
Akeso's sNDA for Ivonescimab in 1L Treatment of PD-L1 Positive NSCLC Accepted by NMPA
2024-05-31
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
2024-05-30
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
2024-04-08
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
2024-03-06
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
2024-02-28
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
2024-01-24
Akeso Presented Promising Results of Cadonilimab and Lenvatinib in Combination with TACE in uHCC at 2024 ASCO GI
2024-01-08
Akeso to Present at the 42nd Annual J.P. Morgan Healthcare Conference and Share Its Corporate & Innovative Clinical Development Roadmap
2023-12-14
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
2023-12-05
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
2023-11-27
Akeso Launches Construction of Shanghai Global R&D Center to Accelerate Its Innovation Globalization Strategy
2023-11-23
Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) Met Primary Endpoint of Progression-Free Survival in Phase III Trial for First-Line Treatment of Recurrent/Metastatic Cervical Cancer in All-Comer Patients
2023-11-07
Akeso’s Cadonilimab (PD-1/CTLA-4) Phase III Trial Meets Primary Endpoint at Interim Analysis Demonstrating Strong Overall Survival Benefit as First-line Treatment in All-comer Patients with Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC)
2023-11-03
Ivonescimab’s Novel Mechanism of Action Highlighting Cooperative Binding to be Featured in Poster Presentation at SITC 2023
2023-10-30
Journal of Thoracic Oncology Published Promising Results of Ivonescimab (PD-1/VEGF Bispecific) as First- or Second-line Therapy for Advanced or Metastatic Immunotherapy Naïve Non-Small-Cell Lung Cancer
2023-10-24
Phase Ib/II Results from Akeso’s PD-1/CTLA-4 Bispecific Antibody for First-Line Treatment for Advanced Hepatocellular Carcinoma Published at 2023 ESMO
2023-10-19
Phase 1a/1b Study Results of Akeso’s PD-1/CTLA-4 Bispecific Antibody Published in Cell Reports Medicine, Highlighting Promising Efficacy in Solid Tumors Refractory/Relapsed to Standard Therapy
2023-10-12
Akeso Announced The Lancet Oncology Publishes Promising Clinical Results from Cadonilimab in Patients with Advanced Solid Tumours (COMPASSION-03/AK104-201)
2023-09-28
Akeso and RemeGen Collaborate on Clinical Study Exploring the Potential of PD-1/CTLA-4 Bispecific Antibody with HER-2 ADC Combination Therapy in Gastric Cancer
2023-09-26
Akeso Announced FDA Clearance of IND for CD47 Monoclonal Antibody (AK117) in Combination with Azacitidine in Myelodysplastic Syndromes
2023-08-30
Akeso Announced 2023 Interim Results: First Profit, Growing Sales of PD-1/CTLA-4 Bispecific Antibody and Priority Review of PD-1/VEGF
2023-08-29
Akeso Announced Completion of Patient Enrollment in Phase 3 Trial of Ivonescimab (PD-1/VEGF) versus Pembrolizumab in First-line PD-L1 Positive Advanced NSCLC
2023-08-25
Akeso Announced that Ivonescimab Granted Priority Review of NDA by China NMPA
2023-08-24
The NDA Acceptance of IL-12/lL-23 Monoclonal Antibody Ebdarokimab for Moderate-to-severe Plaque Psoriasis by China NMPA
2023-08-18
Akeso Announced First Patient Dosed in Phase 3 Trial of Ivonescimab versus Tislelizumab for First-line Treatment of Squamous NSCLC
2023-08-06
The eClinical Medicine of Lancet Published Phase 2 Results of Ivonescimab for the Treatment of NSCLC
2023-06-06
Akeso updated 2-year data from cadonilimab combined with chemotherapy in first line treatment of gastric cancer at 2023 ASCO meeting
2023-06-02
NMPA accepted Akeso's ebronucimab (PCSK9) marketing application in two indications
2023-03-16
Akeso Reported 2022 Annual Results
2023-03-14
Patient Enrollment Completed for Phase III Clinical Trial of Akeso’s Cadonilimab in Treatment of Gastric Cancer
2023-01-16
China NMPA Approved 安尼可® (Penpulimab) for First-line Treatment of Locally Advanced or Metastatic Squamous NSCLC
2022-12-06
Akeso Inc. Announces Collaboration and License Agreement for Up to US$5 Billion with Summit Therapeutics to Accelerate Global Development and Commercialization of its Breakthrough Bispecific Antibody, Ivonescimab (PD-1/VEGF)
2022-11-13
Akeso’s Ivonescimab (PD-1/VEGF Bispecific Antibody, AK112) Granted Breakthrough Therapy Designation for I-O Resistance NSCLC Patients in China
2022-11-04
Akeso Completes Enrollment in Phase III Trial of PD-1/VEGF Bispecific Antibody (AK112) Combined with Chemotherapy in EGFR-TKI-resistant nsq-NSCLC
2022-10-31
Akeso Announces Oral Presentation of Ivonescimab (PD-1/VEGF Bi-Specific) in First-line Treatment of ES-SCLC on ACLC 2022
2022-10-21
Akeso's Ivonescimab(PD-1/VEGF BsAbs) Granted Breakthrough Therapy Designation by China NMPA for the Treatment of Advanced NSCLC
2022-10-17
Akeso's Cadonilimab (PD-1/CTLA-4 Bi-specific) included in the 2022 CSCO Guidelines as the Top Recommendation for Cervical Cancer Immunotherapy
2022-10-17
Akeso Is Developing Combination Therapies Based on Its PD-1 BsAbs, Ivonescimab (PD-1/VEGF) in Combination with Drebuxelimab (CD73) Approved for a Clinical Trial on Treating Advanced Solid Tumors
2022-06-29
Akeso’s Cadonilimab (PD-1/CTLA-4), the First Dual Immune Checkpoint Inhibitor to Treat Cancer, Approved for Marketing in China
2022-06-06
Akeso announces oral presentation featuring promising clinical data of Cadonilimab (PD-1/CTLA-4 BsAbs, AK104) for the first-line treatment of R/M cervical cancer at ASCO 2022
2022-06-06
Akeso releases promising data of Ivonescimab (PD-1/VEGF BsAbs, AK112) combined with chemotherapy in advanced NSCLC at ASCO 2022
2022-06-06
Akeso releases promising data of Ivonescimab (PD-1/VEGF BsAbs, AK112) for advanced NSCLC at ASCO 2022
2022-04-26
Akeso Publishes Preclinical Results of TIGIT monoclonal antibody（AK127）at the American Association for Cancer Research (AACR) 2022 Annual Meeting
2022-04-26
Akeso Publishes Preclinical Results of PD-1/CD73 Bi-specific Antibody（AK131）at the American Association for Cancer Research (AACR) 2022 Annual Meeting
2022-04-26
Akeso Publishes Preclinical Results of PD-1/LAG-3 Bi-specific Antibody（AK129）at the American Association for Cancer Research (AACR) 2022 Annual Meeting
2022-03-08
Akeso Announces IND Approval from China NMPA for Phase II Clinical Trial of Cadonilimab in Combination with Docetaxel to Treat NSCLC
2022-03-02
Akeso Announces Clinical Trial Collaboration with Chipscreen Biosciences to Evaluate Cadonilimab in Combination with Chiauranib for Extensive-Stage Small-Cell Lung Cancer
2022-02-11
AKESO’S NGF MONOCLONAL ANTIBODY (AK115) APPROVED TO INITIATE CLINICAL TRIAL IN PAIN (INCLUDING CANCER PAIN)
2021-11-02
PD-1/VEGF BI-SPECIFIC ANTIBODY (AK112) OBTAINED APPROVAL TO INITIATE A PHASE II CLINICAL TRIAL FOR MONOTHERAPY OR COMBINED CHEMOTHERAPY...
2021-10-22
Akeso, Inc. Doses First Patient in a Clinical Study of Anti-TIGIT Monoclonal Antibody (AK127) in Combination with Cadonilimab (Anti-PD-1/CTLA-4) for Treatment of Advanced or Metastatic Solid Tumors
2021-10-18
Akeso Will Publish Six Latest Research Results at the SITC 2021
2021-10-12
Rapid Advancement of Phase II Clinical Trial of IL-4R Monoclonal Antibody (AK120) for the Treatment of Atopic Dermatitis and Asthma
2021-10-11
AK112 (PD-1/VEGF Bi-Specific Antibody) in Combination with AK117 (CD47 Monoclonal Antibody) Obtained Approval to Initiate Clinical Trial for the Treatment of Advanced Malignant Tumors
2021-10-05
PD-1/VEGF Bi-Specific Antibody (AK112) Obtained Approval to Initiate Clinical Trial for the Treatment of Advanced Triple-Negative Breast Cancer
2021-09-29
Completion of Patient Enrollment for Phase II Clinical Trial of IL-17A Monoclonal Antibody AK111 for Treatment of Moderate-to-Severe Plaque Psoriasis
2021-09-27
IL-4Rα Monoclonal Antibody (AK120) Initiates a Global Phase II Clinical Trial for the Treatment of Moderate-to-Severe Atopic Dermatitis
2021-09-26
Latest Results of a Phase II Clinical Study of PD-1/VEGF Bi-Specific Antibody (AK112) in Combination with Chemotherapy for First-Line Treatment of Advanced NSCLC Published at 2021 CSCO
2021-09-26
Akeso was included in the “Chinese Antibody Drug Companies Innovation TOP 30” by “2020 Chinese Biopharma Companies Innovation TOP 100 Series Lists”
2021-09-24
New Drug Application for Cadonilimab (PD-1/CTLA-4 Bi-Specific Antibody) for the Treatment of Relapsed or Metastatic Cervical Cancer Accepted by NMPA
2021-09-23
2021 CSCO | Latest Results of Two Phase II Clinical Studies of Akeso’s PD-1/VEGF Bispecific Antibody (AK112) for Treatment of Lung Cancer and Ovarian Cancer
2021-09-19
Akeso Publishes Updated Results of a Phase II Study of Penpulimab Monoclonal Antibody for Treatment of Metastatic NPC with Progression after Two or More Lines of Chemotherapy at ESMO 2021
2021-09-19
Akeso’s Latest Updates of a Phase Ib/II Trial of AK104 (PD-1/CTLA-4 Bi-Specific Antibody) in Combination with Anlotinib in Patients with PD-L1 Positive and Anti-PD-1/L1 Resistant Advanced NSCLC at ESMO 2021
2021-09-19
Oral Presentation of Mechanism Study of IgG1 IsoType Anti-PD-1 Monoclonal Antibody Penpulimab at ESMO 2021 by Akeso’s CSO, Dr. Baiyong Li
2021-08-27
Akeso, Inc. Works with Pfizer to Conduct a Clinical Research of Cadonilimab (Bi-specific Antibody) with Combination of Axitinib for the First-line Treatment of Advanced / Metastatic Renal Clear Cell Carcinoma
2021-08-24
Akeso’s PD-1/CTLA-4 Bi-Specific Antibody Obtained Approval from the CDE to Submit NDA and has been Granted Priority Review Designation
2021-08-23
New PD-1 Monoclonal Antibody 安尼可® (Penpulimab) Officially for Sale, First Prescriptions Made Nationwide
2021-08-21
Akeso Shipped off its First Batch of Penpulimab Monoclonal Antibody Injection (安尼可®)
2021-08-09
Akeso’s Latest Updates on the Clinical Trials of Cadonilimab and 安尼可 ® (Penpulimab) will be Published at ESMO 2021
2021-08-05
Penpulimab Monoclonal Antibody (PD-1) Obtains Marketing Approval in China
2021-08-05
New Drug Application for Penpulimab Monoclonal Antibody (PD-1) for Third-Line Treatment of Metastatic Nasopharyngeal Carcinoma Accepted by NMPA
2021-08-04
PD-1/CTLA-4 Bi-specific Antibody in Combination with VEGFR-2 Monoclonal Antibody Obtained Approval to Initiate Phase Ib/II Clinical Trial for Treatment of Advanced Solid Tumors
2021-08-03
Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) Initiated Phase III Clinical Trial for First-Line Treatment of Advanced Gastric Cancer, National Researchers’ Conference Successfully Held
2021-07-13
CD47 Monoclonal Antibody (AK117) Completed Phase I Dose Escalation Trial and Obtained Approval to Initiate Clinical Trial in Combination with Azacitidine for Treatment of Acute Myeloid Leukemia
2021-07-09
Michael Xi: Anti-PD-1 bi-specific antibodies mark the immuno-oncology era 2.0
2021-07-06
Completed Patient Enrollment of the First Cohort with PD-1/CTLA-4 Bispecific Antibody (AK104) in Combination with CD47 Monoclonal Antibody (AK117) for Treatment of Solid Tumors
2021-07-05
Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) in Combination with VEGFR-2 Monoclonal Antibody Obtained Approval to Initiate Phase Ib/II Clinical Trial for Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Cancer
2021-07-02
New Drug Application for Penpulimab Monoclonal Antibody (PD-1) for First-Line Treatment of Squamous Non-Small-Cell Lung Cancer Accepted by NMPA
2021-06-30
Akeso Awarded as 2021 "Most Honored Company" by Institutional Investor
2021-06-21
Akeso among “TOP 10 Chinese Bispecific Antibody Drug Companies” Ranked by BioChina List of China Biopharmaceuticals
2021-06-18
Akeso Dr. Xia Yu and Dr. Wang Zhongmin Win the First “World-Benefiting Pharmaceutical Innovation” Award
2021-06-16
Out-Licensed by Akeso to MSD for US$200 Million, Monoclonal Antibody CTLA-4 Entered Phase III Clinical Trial
2021-06-15
ASCO21 | Latest Updates on Two Akeso’s AK104 (PD-1/CTLA-4 Bispecific Antibody) Clinical Trials
2021-06-11
Akeso Expands Development with New International Center Project Settles in Shanghai
2021-05-24
Akeso Penpulimab Monoclonal Antibody (PD-1) Submitted BLA in the United States
2021-05-20
Latest Updates on the Clinical Trials of AK104, AK112, AK117 and AK105 Published at ASCO 2021
2021-05-18
CD47 Monoclonal Antibody (AK117) Obtained Approval for Phase I/II Clinical Trial for Treatment of Medium- to High-Risk Myelodysplastic Syndromes (MDS)
2021-05-13
Akeso, Inc. Inclusion in the MSCI China Index
2021-05-12
Initiation of Various Clinical Trials of PD-1/VEGF Bispecific Antibody (AK112)
2021-04-28
Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) Obtained Approval to Initiate Phase III Clinical Trial for First-Line Treatment of Advanced Cervical Cancer
2021-04-27
New Level of Production Capacity Expansion Akeso Builds the World’s Largest FlexFactory Platform in Cooperation with Cytiva
2021-03-30
Penpulimab (PD-1) Obtained Breakthrough Therapy Designation from FDA for Third-Line Treatment of Metastatic Nasopharyngeal Carcinoma
2021-03-12
Akeso Guangzhou Manufacturing Base Project Phase I Goes into Operation
2021-03-03
Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) Obtained Orphan Drug Designation from FDA of the United States for Treating Cervical Cancer
2020-07-03
BoB半岛生物董事长兼首席执行官夏瑜女士入选2020福布斯“中国科技女性榜”
2020-05-25
Akesobio Announced NMPA Accepts its new drug Penpulimab (PD-1 Monoclonal Antibody) for the Treatment of relapsed or refractory Classic Hodgkin's Lymphoma
2020-05-11
Akesobio Doses First Patient in Phase 1 Study of AK117, a novel anti-CD47 monoclonal antibody in Australia
2020-04-02
AACR 2020 | Akesobio presents phase Ib/II preliminary results of AK104, a PD-1/CTLA-4 bispecific antibody in combination with chemotherapy as first-line therapy in patients (pts) with advanced gastric (G) or gastroesophageal junction (GEJ) cancer
