Akeso Biopharma Inc.

40 articles about Akeso Biopharma Inc.

• Akeso Announced FDA Clearance of IND for CD47 Monoclonal Antibody (AK117) in Combination with Azacitidine in Myelodysplastic Syndromes

  9/28/2023

  Akeso, Inc. announced that the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug application for AK117, a next generation CD47 monoclonal antibody in combination with azacitidine for treatment of patients with newly diagnosed higher-risk myelodysplastic syndromes.

• Akeso Announced 2023 Interim Results: First Profit, Growing Sales of PD-1/CTLA-4 Bispecific Antibody and Priority Review of PD-1/VEGF

  8/30/2023

  Akeso released its 2023 interim performance: the Company achieved financial profitability for the first time in the first half of 2023, reaping success in new drug development, commercialization and globalization.

• Akeso Announced that Ivonescimab Granted Priority Review of NDA by China NMPA

  8/25/2023

  Akeso Inc. announced that the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China has granted priority review of New Drug Application for ivonescimab, a potential first-in-class investigational PD-1/VEGF bi-specific antibody.

• Akeso Announced First Patient Dosed in Phase 3 Trial of Ivonescimab versus Tislelizumab for First-line Treatment of Squamous NSCLC

  8/18/2023

  Akeso Inc. ("Akeso", 9926. HK) announced today that the first patient has been dosed in a head-to-head phase III trial of ivonescimab, a potential first-in-class investigational PD-1/VEGF bi-specific antibody discovered by Akeso.

• The eClinical Medicine of Lancet Published Phase 2 Results of Ivonescimab for the Treatment of NSCLC

  8/7/2023

  Akeso Inc. announced that eClinical Medicine, a sub-journal of The Lancet, recently published the results of a phase II clinical trial of ivonescimab combined with chemotherapy for the treatment of non-small cell lung cancer.

• Akeso Inc. Published 2023 Interim Results Positive Profit Alert

  7/31/2023

  Akeso Inc. announced that it is expected that the Company will record a profit of not less than RMB2.3 billion for the six months ended June 30, 2023.

• NMPA accepted Akeso's ebronucimab (PCSK9) marketing application in two cardiovascular indications

  6/2/2023

  Akeso Inc. announced that China's National Medical Products Administration has accepted its New Drug Application for its fully human anti-PCSK9 monoclonal antibody ebronucimab for 2 indications 1) primary hypercholesterolemia and mixed hyperlipidemia, and 2) heterozygous familial hypercholesterolemia.

• Akeso Reported 2022 Annual Results

  3/16/2023

  Akeso Inc. released its 2022 annual report. During the reporting period, the company enjoyed booming business development and made breakthrough progress in drug innovation and development, commercialization and internationalization.

• Patient Enrollment Completed for Phase III Clinical Trial of Akeso's Cadonilimab in Treatment of Gastric Cancer

  3/14/2023

  Akeso, Inc. announced that patient enrollment has been completed for its pivotal Phase III clinical trial for cadonilimab, the world's first approved and marketed dual-immune checkpoint bi-specific antibody drug, for use in combination with chemotherapy as first-line therapy for advanced gastric or gastroesophageal junction cancer.

• JITC publication of Akeso's Ligufalimab(CD47 monoclonal antibody) mechanism shows promising antitumor efficacy and favorable safety profile

  12/12/2022

  Akeso Inc. announced that the Journal for Immunotherapy of Cancer, a BMJ oncology journal, published the mechanism of action of its Ligufalimab.

• 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)

  12/6/2022

  Akeso Inc. to out-license to Summit Therapeutics exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan.

• Summit Therapeutics Partners with Akeso Inc. in Deal for Up to $5 Billion to In-License Breakthrough Innovative Bispecific Antibody$500 Million Upfront Payment to Activate the Partnership for Ivonescimab

  12/6/2022

  Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced a definitive agreement of its partnership with Akeso Inc. (HKEX Code: 9926.HK, “Akeso”), to in-license its breakthrough bispecific antibody, ivonescimab.

• Akeso's Ivonescimab (PD-1/VEGF Bispecific Antibody, AK112) Granted Breakthrough Therapy Designation for I-O Resistance NSCLC Patients in China

  11/14/2022

  Akeso, Biopharma announced that the Center for Drug Evaluation of the China National Medical Products Administration has granted Breakthrough Therapy Designation for Ivonescimab combined with docetaxel for the treatment of locally advanced or metastatic Non-Small-Cell Lung Carcinoma patients who failed to respond to prior PD-1 inhibitor combined with platinum-based doublet chemotherapy.

• Akeso Completes Enrollment in Phase III Trial of PD-1/VEGF Bispecific Antibody (AK112) Combined with Chemotherapy in EGFR-TKI-resistant nsq-NSCLC

  11/4/2022

  Akeso, Biopharma announced the patient enrollment completion for the Phase III clinical trial of Ivonescimab combined with chemotherapy for the treatment of EGFR-mutant locally advanced or metastatic non-squamous non-small cell lung cancer who have failed to epidermal growth factor receptor tyrosine kinase inhibitor treatment.

• Akeso Announces Oral Presentation of Ivonescimab (PD-1/VEGF Bi-Specific) in First-line Treatment of ES-SCLC on ACLC 2022

  10/31/2022

  Akeso, Biopharma released the Phase Ib clinical results of Ivonescimab in combination with etoposide and carboplatin in first-line treatment of extensive-stage small-cell lung cancer, in an oral presentation at the IASLC 2022 Asia Conference on Lung Cancer.

• Akeso's Ivonescimab (PD-1/VEGF BsAbs) Granted Breakthrough Therapy Designation by China NMPA for the Treatment of Advanced NSCLC

  10/20/2022

  Akeso, Inc. (9926. HK) ("Akeso") announced that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for Ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy for treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR-mutated who failed to prior EGFR-TKI treatment.

• Akeso's Cadonilimab (PD-1/CTLA-4 Bi-specific) included in the 2022 CSCO Guidelines as the Top Recommendation for Cervical Cancer Immunotherapy

  10/17/2022

  Chinese Society of Clinical Oncology, an authoritative Chinese oncology institution, recently published the 2022 CSCO Guidelines on Diagnosis and Treatment of Cervical Cancer.

• 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

  10/17/2022

  Akeso, Inc. announced the Phase Ib/II clinical trial of its in-house developed Ivonescimab combined with its Drebuxelimab for the treatment of advanced solid tumors, has been approved by the National Medical Products Administration.

• First and only TIGIT/TGF-β dual-targeting antibody fusion protein of Akeso demonstrated promise in preclinical results published at ESMO

  9/13/2022

  Akeso, Inc. published encouraging preclinical results in poster featuring its Fc-mutant anti-TIGIT antibody fused with TGF-βRII protein at the European Society for Medical Oncology Congress 2022.

• First approval of Cadonilimab (PD-1/CTLA-4 bispecific) published in Drugs, a peer-reviewed medical journal

  8/26/2022

  Akeso, Inc. announced a review article featuring on Cadonilimab, a first-in-class PD-1/CTLA-4 bi-specific antibody developed by the company, was published in Drugs, a peer-reviewed medical journal specializing in pharmaceutics.