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

• 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.

Forward-Looking Statements

This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.

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SOURCE Akeso, Inc.