Akeso Announces Completion of Patient Enrollment in Phase III Clinical Trial for Ivonescimab as First-Line Treatment for Biliary Tract Cancer Compared to PD-L1 Therapy

Akeso Announces Completion of Patient Enrollment in Phase III Clinical Trial for Ivonescimab as First-Line Treatment for Biliary Tract Cancer Compared to PD-L1 Therapy

HONG KONG, Sept. 2, 2025 /PRNewswire/ -- Akeso (9926.HK) has recently announced the completion of patient enrollment in its Phase III, multicenter, randomized, controlled, registrational study evaluating ivonescimab, in combination with standard therapy, against durvalumab (PD-L1) combination therapy, for the first-line treatment of advanced biliary tract cancer (BTC) (AK112-309/HARMONi-GI1). This Phase III trial is being conducted in China.

Ivonescimab has previously shown significant positive results in the randomized, double-blind, controlled Phase III study (HARMONi-2), where it was compared head-to-head with pembrolizumab. These results led to its approval as a first-line treatment for PD-L1-positive non-small cell lung cancer (NSCLC), marking its second approved indication. In addition, the Phase III trial of ivonescimab in combination with chemotherapy compared to tislelizumab combined with chemotherapy as a first-line treatment for squamous NSCLC, also delivered significant positive outcomes. These results highlight ivonescimab's strong clinical breakthroughs. Whether compared to PD-1 monotherapy, PD-1 plus chemotherapy (current standard therapies for various cancers), or VEGF-related treatments, ivonescimab has consistently demonstrated its ability to drive clinical innovation.

Ivonescimab continues to validate its clinically meaningful profile and potential with a strategically expanded development program targeting key immuno-oncology settings:

Phase III trials for Lung cancer (8 registrational/Phase III trials, 4 already met primary endpoints):

• First-line NSCLC, squamous and non-squamous (versus pembrolizumab + chemotherapy; global trial)
• First-line squamous NSCLC (versus tislelizumab + chemotherapy)
• NSCLC after progression on EGFR-TKI therapy (HARMONi-A and HARMONi studies)
• First-line PD-L1-positive NSCLC (versus pembrolizumab monotherapy)
• First-line PD-L1-high expressing NSCLC (versus pembrolizumab)
• IO-resistant NSCLC
• Consolidation therapy for limited-stage small cell lung cancer (LS-SCLC) without progression after concurrent chemoradiotherapy (cCRT)

Phase III trials for core immuno-oncology indications (first-line therapy ):

• First-line biliary tract cancer (versus durvalumab + chemotherapy)
• First-line PD-L1-positive head and neck squamous cell carcinoma (HNSCC) in combination with ligufalimab (anti-CD47) versus pembrolizumab

Phase III trials for cold tumors and more:

• First-line triple-negative breast cancer (TNBC)
• First-line MSS/pMMR colorectal cancer (representing about 95% of CRC cases)
• First-line pancreatic cancer
• Additional global Phase III trials are in advanced stages of planning

An extensive clinical foundation includes over 20 Phase II studies across more than 10 additional tumor types, generating compelling efficacy and safety data that enable rapid transition to further registrational studies worldwide.

Ivonescimab uniquely targets both PD-1 and VEGF, producing a synergistic anti-tumor effect. This dual mechanism not only combines the benefits of PD-1 and VEGF inhibition but also overcomes the efficacy and safety limitations of each target alone, resulting in pronounced clinical benefits. These advantages have been confirmed across multiple Phase III trials and real-world use, rapidly establishing ivonescimab as a next-generation leader in immunotherapy and anti-angiogenic therapy.

For context, pembrolizumab (anti-PD-1) is approved for over 40 oncology indications, and bevacizumab (anti-VEGF) for more than 10. Akeso is implementing a dual-path strategy to maximize the value of ivonescimab worldwide: accelerating domestic commercialization and label expansion in China, while simultaneously advancing global development in partnership with Summit Therapeutics.

Forward-Looking Statement of Akeso, Inc.
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.

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, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.

For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.

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