HONG KONG, Sept. 3, 2026 /PRNewswire/ — Akeso, Inc. (9926.HK) (“Akeso” or the “Company”) today announced that a pre-specified interim analysis of overall survival (OS) in the HARMONi-2 (AK112-303) trial, as assessed by the Independent Data Monitoring Committee (IDMC), met the key secondary endpoint of OS. The results demonstrated that ivonescimab showed statistically significant and clinically meaningful improvement over pembrolizumab.
HARMONi-2 is a randomized, double-blind, multicenter, registrational Phase III trial evaluating ivonescimab, Akeso’s first-in-class PD-1/VEGF bispecific antibody, versus pembrolizumab as first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (TPS ≥1%).
Detailed data from the interim OS analysis will be presented at an upcoming international medical conference and published in a peer-reviewed journal.
In May 2024, at a prespecified interim analysis conducted by the IDMC, ivonescimab met its primary endpoint of progression-free survival (PFS) in the HARMONi-2 study, with a median PFS of 11.14 months versus 5.82 months for pembrolizumab. HARMONi-2 is the first randomized, double-blind Phase III trial to show a significant positive outcome against pembrolizumab in this setting.
In 2025, this indication received regulatory approval in China. The approval removed previous restrictions on the use of VEGF-targeted agents in patients with squamous histology and provided a chemotherapy-free treatment option that has been well received in clinical practice.
Dr. Yu Xia, Founder, Chairwoman, President and Chief Executive Officer of Akeso:
“We are pleased that the fourth Phase III study of an ivonescimab-based regimen has now demonstrated statistically significant benefit in both overall survival and progression-free survival. These results further reinforce the clinical value of ivonescimab in the treatment of lung cancer.
We thank the investigators, clinical teams and patients who participated in the HARMONi-2 study for their important contributions.
To date, ivonescimab has achieved dual positive OS and PFS outcomes across multiple Phase III head-to-head trials versus PD-1/PD-L1 therapies. This growing body of evidence strengthens our confidence in its potential across a broader range of solid tumors. With its unique dual mechanism of action combining immunotherapy and anti-angiogenesis, we believe ivonescimab offers a more effective treatment option for patients and will contribute meaningfully to the evolving oncology treatment landscape.”
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, nearly 30 candidates have advanced into clinical trials, including 15 bispecific or multispecific antibodies and bispecific ADCs. Eight innovative drugs are commercially available, and two additional drugs with three indications are currently under regulatory review for marketing approval.
Akeso is committed to becoming a global leader in biopharmaceuticals through efficient and breakthrough innovation in R&D, developing novel therapies that are first-in-class or best-in-class, and providing better disease solutions for patients around the world.
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 the 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.
