Ligufalimab (CD47)-Based Combination Achieves Deep Responses and Survival Benefit in Frontline AML: Phase II Results Presented in Oral Session at EHA 2026

Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that compelling results from its randomized, double-blind, placebo-controlled Phase II trial (AK117-206) of ligufalimab (AK117) were presented as an oral presentation at the 2026 European Hematology Association (EHA) Congress. Ligufalimab is Akeso's proprietary next-generation humanized IgG4 anti-CD47 monoclonal antibody. The study evaluated ligufalimab in combination with azacitidine (AZA) and venetoclax (VEN) in patients with treatment-naïve acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. Ligufalimab-based combination therapy demonstrates a significant trend toward survival benefit At a median follow-up of 10 months in the ligufalimab group and 8.8 months in the control group, median event-free survival (EFS) was 9.1 months in the ligufalimab group versus 6.9 months in the control group (hazard ratio [HR] = 0.46). The 6-month EFS rate was 67.8% versus 55.5% in the control group, and the 9-month EFS rate was 53.2% versus 14.1%. Median overall survival (mOS) was not reached in the ligufalimab group versus 8.3 months in the control group (HR = 0.46). The 6-month OS rate was 83.3% versus 73.2%, and the 9-month OS rate was 78.7% versus 43.1% in the control group. Ligufalimab-based combination therapy yields deep tumor responses The objective response rate (ORR) was 80.0% in the ligufalimab group versus 66.7% in the control group, and the composite complete response (CRc) rate was 56.7% versus 53.3%; the proportion of patients achieving CRc with minimal residual disease (MRD) negativity was higher in the ligufalimab group than in the control group (46.7% vs. 36.7%). The median duration of CRc was 10.4 months in the ligufalimab group, which was markedly superior to 5.6 months in the control group. Favorable Safety Profile With No New Safety Signals Observed The incidence of overall treatment-emergent adverse events (TEAEs) and serious adverse events was comparable between treatment arms. The most common TEAEs were generally consistent with those expected in the context of AML and AZA+VEN therapy. Anemia occurred in 46.7% of patients in the ligufalimab arm versus 50.0% in the control arm. Notably, ligufalimab has already received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of AML. Akeso is advancing its ligufalimab clinical development programs at a globally competitive pace across both hematologic malignancies and solid tumors. Ligufalimab is also the first anti-CD47 monoclonal antibody worldwide to enter a registrational Phase III clinical trial in solid tumors. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, Akeso has built a comprehensive R&D innovation ecosystem anchored by its proprietary Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Backed by world-class GMP manufacturing facilities and a highly efficient, integrated commercialization system, Akeso has developed into a globally competitive biopharmaceutical enterprise. Leveraging its fully integrated, multi-functional platform, the company maintains a robust pipeline of more than 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic disorders, and other major therapeutic areas. Of these, 27 candidates have advanced into clinical trials—including 15 bispecific or multispecific antibodies and bispecific ADCs—and 8 innovative drugs have reached commercial stage. Through efficient and groundbreaking R&D, Akeso integrates premier global resources to develop transformative medicines, deliver high-quality, affordable therapeutic antibodies to patients worldwide, and generate sustained commercial and societal value as it strives to become a global leader in biopharmaceutical innovation.