Phase II Data from a Randomized Double-Blind Trial of Ligufalimab (Anti-CD47) Combination Therapy in Frontline AML Published at EHA 2026

HONG KONG, May 15, 2026 /PRNewswire/ -- 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) will be presented as an oral presentation at the 2026 European Hematology Association (EHA) Congress. The abstract is now available on the EHA Congress platform.

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.

The abstract data demonstrated that the ligufalimab-based triplet regimen delivered encouraging efficacy, with significant improvements in survival outcomes. The combination also showed a manageable safety profile, offering a potentially better-tolerated treatment option for this vulnerable patient population.

As of the November 2025 data cutoff, key findings included:

Deep and Durable Tumor Remission

• The objective response rate (ORR) was 80.0% in the ligufalimab arm versus 66.7% in the control arm, with a composite complete remission (CRc) rate of 56.7% versus 53.3%. Among patients achieving CRc, the measurable residual disease (MRD) negativity rate was higher in the ligufalimab arm (46.7% versus 36.7%).
• Median duration of CRc was substantially longer in the ligufalimab arm at 10.4 months versus 6.5 months in the control arm.

Encouraging Survival Benefit Trend

• At a median follow-up of 8.84 months, median overall survival (mOS) in the ligufalimab arm was not yet reached, versus 8.3 months in the control arm. The 9-month overall survival rate was 78.7% in the ligufalimab arm versus 43.1% in the control arm; the 6-month OS rates were 83.3% versus 73.2%, respectively.

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, the company has established a robust R&D innovation ecosystem centered on its 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. Supported by a global-standard GMP manufacturing infrastructure and a highly efficient, integrated commercialization model, the company has evolved into a globally competitive biopharmaceutical focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 27 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

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.

SOURCE Akeso, Inc.