The board of directors of the Akeso, Inc. announced that the latest results of Phase Ib/II clinical study for its first-in-class bi-specific antibody novel drug Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and development code: AK104), a novel immuno-oncology therapy independently developed by the Company, in combination with chemotherapy as first-line therapy on patients with advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer were published at the Gastrointestinal Cancers Symposium 2021 (2021 ASCO GI). As of the data cut-off date of November 2020, the confirmed objective response rate (ORR) for GC or GEJ patients receiving Cadonilimab in combination with oxaliplatin and capecitabine as first-line therapy was 64.1%, representing a disease control rate (DCR) of 87.2%. The median follow-up time for 4mg/kg cohorts patients was 8.0 months. The median duration of response (DoR) was not achieved, and the 6-month progression-free survival (PFS) was 76.5%. In terms of the enrolled 10mg/kg cohorts patients, three cases had partial responses (75%) and target lesions for one case shrined by 22%. All of them are still on the treatment. According to the study, Grade 3 or higher adverse reactions in relation to Cadonilimab or chemotherapy was 38.9% and incidence rate of Grade 3 or above immune-related adverse reactions was 7.4%. According to the study, Cadonilimab 10 mg/kg dosed once every two weeks (Q2W) in combination with chemotherapy for the first-line treatment of GC or GEJ has favorable safety profile and dosage tolerance. Cadonilimab, in combination with chemotherapy for the first-line treatment of GC or GEJ, is showing remarkable anti-tumor activities in all dosing levels, demonstrating a sustainable tumor response and is able to improve PFS for patients with advanced GC. Currently, the Phase III study for Cadonilimab in combination with chemotherapy for the first-line treatment of GC or GEJ is still under planning. Cadonilimab is planned to apply to major indications such as liver cancer, cervical cancer, lung cancer, esophageal squamous cell carcinoma and nasopharyngeal cancer.