Ivonescimab Plus Chemotherapy Demonstrates Significant Overall Survival Benefit Versus Durvalumab Plus Chemotherapy in First-Line Biliary Tract Cancer: HARMONi-GI1 Meets Primary Endpoint

HONG KONG, Aug. 25, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that a pre-specified interim analysis assessed by the Independent Data Monitoring Committee (IDMC) of the randomized, controlled, double-blinded, multicenter, registrational Phase III clinical study (AK112-309/HARMONi-GI1) of ivonescimab in combination with chemotherapy versus durvalumab (PD-L1 monoclonal antibody) in combination with chemotherapy for the first-line treatment of advanced biliary tract cancer (BTC), showed that the study met its primary endpoint of overall survival (OS), achieving a clinically meaningful and statistically significant positive result. The study also met all key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR).

Detailed results from this study will be presented at an upcoming international academic conference and published in a peer-reviewed journal.

Durvalumab in combination with chemotherapy is currently the preferred first-line immunotherapy regimen recommended by international guidelines and is regarded as the optimal standard of care (SOC). HARMONi-GI1 is the first Phase III study in biliary tract cancer to demonstrate a statistically significant positive OS result versus the global gold standard (PD-L1 monoclonal antibody plus chemotherapy), representing a major milestone in the treatment of this difficult disease.

Dr. Michelle Xia, Founder, Chairwoman, President and CEO of Akeso:
"We are delighted the Phase III clinical study of ivonescimab in combination with chemotherapy versus durvalumab in combination with chemotherapy for the first-line treatment of biliary tract cancer has achieved a statistically significant positive OS result. This is a major breakthrough for the treatment of biliary tract cancer.

"We sincerely thank the investigators, study teams, and patients who made HARMONi-GI1 possible. Their important contributions bring us closer to an innovative, safe, and highly effective new treatment option against this aggressive cancer.

"The positive result of HARMONi-GI1 marks the first positive Phase III study for ivonescimab in gastrointestinal tumors, following four positive Phase III results in lung cancer. The breakthrough clinical value of ivonescimab is now expanding from lung cancer to a broader range of solid tumors. We look forward to making this innovative therapy available to patients worldwide as soon as possible."

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.

SOURCE Akeso, Inc.