Ivonescimab First-Line Biliary Tract Cancer Phase III Overall Survival Data Selected as ESMO Late-Breaking Abstract; Nearly 30 Akeso Studies to Be Presented at ESMO 2026

HONG KONG, Sept. 21, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that nearly 30 clinical studies of its globally first-in-class bispecific antibodies will be presented at the 2026 European Society for Medical Oncology (ESMO) Congress, taking place October 23–27 in Madrid, Spain. The presentations include one Late-Breaking Abstract (LBA) selected for the Presidential Symposium and two oral presentations.

Ivonescimab, the world's first approved PD-1/VEGF bispecific antibody, will be featured in 12 presentations at ESMO 2026. Notably, positive overall survival results from the Phase III HARMONi-GI1 trial evaluating ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer have been selected as a Late-Breaking Abstract for the Presidential Symposium and will be delivered as a late-breaking oral presentation. In addition, two rapid oral presentations will present breakthrough data on ivonescimab-based regimens as first-line treatment for advanced renal cell carcinoma and recurrent/metastatic thymic carcinoma. The presentations will also highlight ivonescimab's expanding development across multiple tumor types, including continued progress in lung cancer (including brain metastases), gastrointestinal cancers (esophageal and gastric cancer), and rare or difficult-to-treat malignancies such as pancreatic cancer, glioblastoma, endometrial cancer, thymic carcinoma, and head and neck squamous cell carcinoma.

Cadonilimab, the world's first PD-1/CTLA-4 bispecific antibody, will be featured in 15 presentations covering more than ten tumor types, including gastric cancer, renal cell carcinoma, lung cancer, esophageal squamous cell carcinoma, colorectal cancer, nasopharyngeal carcinoma, ovarian cancer, soft tissue sarcoma, pleural mesothelioma, and rectal cancer. These studies span neoadjuvant settings as well as first- and second-line treatment of advanced disease, underscoring the broad anti-tumor potential of this dual checkpoint inhibitor.

The extensive data to be presented at ESMO 2026 reflect Akeso's ongoing commitment to advancing next-generation immuno-oncology therapies for major global diseases and our continued efforts to build a differentiated global oncology portfolio. Full results will be released during the Congress. Please stay tuned for updates.

Key Presentations Highlights:

LBA8 - Ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double- blinded, Phase 3 trial (HARMONi-GI1)

• Speakers: Jian Zhou (Shanghai, China)
• Session Name: Presidential Symposium II
• Room: Alicante Auditorium - Hall 6
• Date: Sunday, 25 October 2026
• Time: 16:30 - 18:15 (Madrid)

Efficacy and Safety of AK112 (Ivonescimab), a PD-1/VEGF Bispecific Antibody, as First-Line Treatment for Patients with IMDC Favorable-Risk Advanced Renal Cell Carcinoma (aRCC): Results from a Phase Ib/II Study

• Session: Rapid Oral 2: Genitourinary tumours, renal and urothelial 
• Abstract: 3592RO 
• Presentation time: Sunday, 25 October 2026, 14:45–16:15 (Madrid) 
• Presenter: Professor Xieqiao Yan, Peking University Cancer Hospital

Ivonescimab plus chemotherapy as first-line treatment in recurrent/metastatic thymic carcinoma: interim results from the iTHYM study

• Session: Rapid Oral: Non-metastatic NSCLC and other thoracic malignancies 
• Abstract: 4156RO 
• Presentation time: Monday, 26 October 2026, 10:15–11:45 (Madrid)
• Presenter: Professor Xue Hou, Sun Yat-sen University Cancer Center

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 multi-specific 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 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.