Akeso’s PD-1/CTLA-4 Bi-Specific Antibody Obtained Approval from the CDE to Submit NDA and has been Granted Priority Review Designation

(HONG KONG, 24 Aug 2021) Akeso, Inc. (9926.HK) announces that the phase II registrational clinical trial of Cadonilimab (PD-1/CTLA-4 bi-specific antibody, AK104), the global first-in-class novel drug independently developed by Akeso for the treatment of relapsed or metastatic cervical cancer, has reached primary endpoint and achieved significant encouraging results.


Akeso has obtained an approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China to submit the new drug application (NDA) for the treatment of relapsed or metastatic cervical cancer and has been granted priority review designation. Therefore, Cadonilimab is expected to be the first PD-1 based bi-specific antibody drug worldwide to submit NDA and receive approval for market launch.


The data analysis of the phase II pivotal clinical trial has shown favorable efficacy and safety results of Cadonilimab for treating patients suffering from relapsed or metastatic cervical cancer after the failure of platinum-based chemotherapy. Among the target indication population, Cadonilimab has shown potential for better efficacy compared to the published data of PD-1 monoclonal antibody in the market. Relevant clinical data will be published in relevant international medical conferences or medical journals.


Based on its well-performing clinical data, the clinical trial of Cadonilimab for the treatment of relapsed or metastatic cervical cancer after standard therapies was approved by the CDE to be included in the ‘‘Breakthrough Therapy Designation’’ in October 2020. In addition, the clinical trial of Cadonilimab was also recognized by the Food and Drug Administration of the United States (FDA). Cadonilimab has obtained fast track designation from the FDA in July 2020 for the treatment of relapsed or metastatic cervical cancer after the failure of platinum-based chemotherapy treatment, and the orphan drug designation from the FDA in February 2021 for the treatment of cervical cancer. The phase III clinical trial of Cadonilimab in combination with chemotherapy for first-line treatment of advanced cervical cancer has also been initiated in July 2021.


Information about Cadonilimab (PD-1/CTLA-4 Bi-Specific Antibody, AK104)

Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bi-specific PD-1/ CTLA-4 immuno-oncology backbone drug independently developed by the Company, and its major indications include liver cancer, cervical cancer, lung cancer, gastric cancer, esophageal squamous cell cancer and nasopharyngeal carcinoma. The preliminary research data of cervical cancer, gastric cancer and other tumors shows that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab has much lower toxicity and demonstrated promising safety profile and efficacy.     


Information about Akeso, Inc.

The Company is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable   to patients worldwide. Since the Company’s establishment, the Company has established an end-to-end comprehensive drug development platform (ACE Platform) and system, encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant scale production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology). The Company currently has a pipeline of over 20 innovative drugs for the treatment of major diseases like tumors, autoimmune diseases, inflammation and metabolism diseases, 13 of which have entered clinical stage, including two first-in-class bi-specific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). The Company’s vision is to become a global leading biopharmaceutical company through research and development of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.