Phase II Trial of Cadonilimab(PD-1/CTLA-4) Combination Regimen Launches in the United States for Perioperative Treatment of Gastric Cancer

This Phase II study will generate robust clinical evidence to support the future initiation of an international multicenter Phase III trial of the cadonilimab combination regimen for the perioperative treatment of GC/GEJ adenocarcinoma.

Cadonilimab and ivonescimab, as first-in-class bispecific antibodies with breakthrough global clinical value, have garnered significant attention and recognition from the international medical community. These innovative IO 2.0 therapies are increasingly favored by global partners as the preferred backbone for combination regimens and novel treatment paradigms across a wide range of cancers. Their global therapeutic value continues to be scientifically explored and realized through ongoing clinical data and new studies.

Building on cadonilimab's unique dual-target synergistic mechanism, this Phase II study is supported by strong evidence from the Phase III COMPASSION-15 trial and previous Phase II neoadjuvant studies in gastric/GEJ adenocarcinoma.

Gastric cancer is the fifth most common malignancy worldwide, with nearly one million new cases annually. For patients with locally advanced, resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma, standard perioperative FLOT chemotherapy achieves a 3-year overall survival rate of only 48%. Although the addition of PD-1 inhibitors to FLOT has become the new standard of care, the pathologic complete response (pCR) rate remains limited at approximately 19%, and nearly one-third of patients experience disease recurrence or death within two years. Dual PD-1/CTLA-4 inhibition has shown limited benefit due to overlapping toxicities and increased early mortality. A significant unmet medical need persists for more effective and better-tolerated treatment options.

As the first approved bispecific antibody for cancer immunotherapy, cadonilimab has demonstrated breakthrough clinical benefits across multiple pivotal studies and is now widely used in clinical practice. More than 12 registrational or Phase III studies of cadonilimab are currently underway globally, including two international multicenter registrational/Phase III trials led by Akeso.

In addition, Akeso is collaborating with INOVIO to explore a novel combination regimen using INOVIO's DNA-based therapy for glioblastoma (GBM) at Dana-Farber Cancer Institute and Mass General Brigham. The Company continues to accelerate the global development of cadonilimab through strategic partnerships with leading therapeutics and institutions.

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.