Akeso, Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce the completion of patient enrollment for its Phase III registrational clinical trial (COMPASSION-22/AK104-306) evaluating cadonilimab, the world's first PD-1/CTLA-4 bispecific antibody independently developed by the company, as an adjuvant treatment for hepatocellular carcinoma (HCC) with high recurrence risk following curative resection or ablation.

The completion of patient enrollment in the COMPASSION-22/AK104-306 trial marks a significant milestone in the clinical development of cadonilimab for HCC. In addition to this Phase III study, another Phase III trial investigating cadonilimab in combination with lenvatinib and transarterial chemoembolization (TACE) for the treatment of unresectable intermediate to advanced HCC is currently progressing on schedule. The extensive exploration of combination therapies involving cadonilimab for HCC is expected to offer more effective treatment options for both early-stage and advanced HCC patients.

HCC is one of the most common malignant tumors globally. According to 2024 data, there are about 865,000 new cases of liver cancer worldwide, with 370,000 occurring in China. The recurrence rate after surgery is high, especially in patients with high-risk factors, with a five-year recurrence rate exceeding 70%. Currently, no standard adjuvant treatment exists for HCC in clinical practice. Identifying effective adjuvant therapies to reduce recurrence risk and extend survival is a critical unmet need in HCC treatment.

Cadonilimab is the world's first approved bispecific immunotherapy for cancer. Previous studies have shown its significant efficacy and favorable safety profile in treating HCC. Research presented at the 2023 European Society for Medical Oncology (ESMO) Asia Annual Meeting demonstrated that cadonilimab combined with FOLFOX-HAIC as neoadjuvant therapy for resectable multinodular HCC achieved a 100% disease control rate (DCR) with manageable safety. Furthermore, data from the 2023 ESMO Congress highlighted that cadonilimab combined with lenvatinib as a first-line treatment for advanced HCC showed superior antitumor activity compared to approved therapies, effectively controlling tumor progression and offering long-term survival benefits over current treatment options.

Akeso will continue to advance cadonilimab clinical development for multiple malignant tumors, with the aim to provide more therapeutic options for patients worldwide. Currently, cadonilimab is currently involved in over 23 clinical studies across 16 indications, including gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer. It has already received approval for the treatment of recurrent/metastatic cervical cancer and first-line gastric cancer. The sNDA for cadonilimab for the treatment of first-line cervical cancer is currently under review. Additionally, five Phase III trials for HCC, non-small cell lung cancer (NSCLC), and gastric cancer are underway. Studies across multiple indications, including cervical cancer, gastric cancer, and NSCLC, have shown that cadonilimab offers meaningful efficacy benefits in all patient populations, regardless of PD-L1 expression levels (high, low, or negative). These patient data indicates that cadonilimab can also significantly broadens the eligible patient population that can benefit from cancer immunotherapies