Akeso, Inc. announced that data from the Phase II study (COMPASSION-25) for its first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, in combination with SOX regimen (oxaliplatin + tegafur/gimeracil/oteracil) as neoadjuvant therapy for resectable gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, was presented at the 2025 ESMO Asia Congress. Currently, Akeso is running the pivotal Phase III study (AK104-310/COMPASSION-33) investigating cadonilimab combined with the SOX regimen for perioperative treatment of resectable G/GEJ adenocarcinoma. This regimen is expected to further push the efficacy boundaries beyond existing single-target immunotherapies and establish a new standard for perioperative immunotherapy in gastric cancer.

This mechanism provides a stronger anti-tumor effect compared to PD-1/L1 monotherapies. Currently, cadonilimab's clinical value in gastric cancer is scientifically well-established. Beyond its ongoing phase III clinical trial in the perioperative setting, cadonilimab combined With chemotherapy as a first-line treatment for advanced gastric cancer (with survival benefits across the PD-L1 expression levels) has been approved for commercialization in China.

Additionally, a pivotal phase III trial exploring cadonilimab in combination with pulocimab (VEGFR-2) for immune therapy-resistant advanced gastric cancer is currently ongoing and is expected to offer a new therapeutic option for later-line gastric cancer. Collectively, these pivotal phase III studies will expand the use of cadonilimab, paving the way for a comprehensive gastric cancer treatment options that spans from advanced, unresectable gastric cancer to early-stage, resectable disease. 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. R 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.