Core Viewpoint - Akeso, Inc. has initiated a global Phase II registrational trial for cadonilimab, a bispecific antibody, to treat advanced hepatocellular carcinoma (HCC) in patients previously treated with atezolizumab and bevacizumab, marking a significant step in cancer immunotherapy development [1][2]. Group 1: Clinical Trials and Development - The COMPASSION-36 trial is the first global registrational Phase III trial for cadonilimab, currently being conducted in China, the U.S., and Europe, highlighting Akeso's commitment to advancing cancer treatment [2]. - Additional Phase III clinical trials for cadonilimab are in preparation, with a focus on both in-house development and open collaboration to enhance treatment accessibility [3]. - Patient enrollment for a Phase III trial of cadonilimab as adjuvant therapy for high-risk recurrence after curative surgery for HCC has been completed, and another trial combining cadonilimab with lenvatinib and TACE is ongoing [8]. Group 2: Market Need and Treatment Landscape - There is a critical need for effective second-line treatment options for patients with advanced malignancies who have progressed after immune checkpoint inhibitor (IO) combination therapies, as current options are limited [4]. - Hepatocellular carcinoma (HCC) is a prevalent malignancy, with approximately 865,000 new cases reported globally in 2022, and there are currently no FDA-approved second-line therapies available in the U.S. for patients who progress after first-line treatment [5]. - The combination of cadonilimab with other therapies has shown promising results in overcoming IO resistance and achieving high disease control rates in various studies [6][7]. Group 3: Company Overview - Akeso is a leading biopharmaceutical company focused on developing innovative biological medicines, with a robust pipeline of over 50 assets in various disease areas, including cancer [13]. - The company utilizes a comprehensive end-to-end drug development platform and has developed a unique integrated R&D innovation system, positioning itself as a globally competitive entity in the biopharmaceutical industry [13].