[ET Net News Agency, 3 August 2021] Akeso, Inc. (09926) said the company has received
the approval from the National Medical Products Administration of the People's Republic of
China to initiate a phase III pivotal registrational clinical trial for the global
first-in-class novel drug Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research and
development code: AK104), an immuno-oncology therapy independently developed by the
company, in combination with oxaliplatin and capecitabine (XELOX) versus placebo in
combination with XELOX for first-line treatment of advanced gastric adenocarcinoma or
gastroesophageal junction cancer (clinical registration number: CTR20211567).
The clinical trial is led by Beijing Cancer Hospital as the leading research centre, and
it plans to recruit approximately 500 patients to evaluate the efficacy and safety of
Cadonilimab in combination with chemotherapy, with progression-free survival (PFS) and
overall survival (OS) as primary endpoints. (RC)