HONG KONG, Dec. 10, 2025 — Akeso, Inc. (9926.HK) (“Akeso” or the “Company”) presented longer-term efficacy data from a Phase II clinical study at the 2025 European Society for Medical Oncology Immuno-Oncology Congress (ESMO IO) in London, UK. The data evaluated ivonescimab, a PD-1/VEGF bispecific antibody, in combination with chemotherapy as a first-line treatment for locally advanced or metastatic triple-negative breast cancer (TNBC).
Due to its positive efficacy and safety profile, this combination therapy for first-line TNBC was previously granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). A multicenter, randomized, double-blind Phase III clinical trial (HARMONi-BC1/AK112-308) for this indication is now underway.
Initial findings from the study were shared at the European Society for Medical Oncology (ESMO) Congress 2024 and the 2024 San Antonio Breast Cancer Symposium (SABCS). With the follow-up period extended to 22.1 months, the new data further confirms the treatment’s efficacy and safety in first-line TNBC.
As of the data cutoff on July 15, 2025, 36 TNBC patients were enrolled. The median age was 55, 83.3% of patients had a PD-L1 combined positive score (CPS) <10, and 55.6% had prior taxane-based neo/adjuvant therapy. Of these, 35 patients had at least one post-baseline tumor assessment and were included in the efficacy analysis. The results indicated that the ivonescimab-chemotherapy regimen provided effective tumor reduction, disease control, and survival benefits across all PD-L1 subgroups. Key outcomes include:
- In the overall population, the objective response rate (ORR) was 80.0%, the disease control rate (DCR) was 100.0%, and the median duration of response (mDOR) was 12.2 months; median progression-free survival (mPFS) was 15.2 months, with a 12-month PFS rate of 56.3%.
- In the CPS≥10 subgroup, the ORR was 83.3%, DCR was 100%, mDOR was 12.2 months; mPFS was 15.9 months, with a 12-month PFS rate of 66.7%.
- In the CPS<10 subgroup, the ORR was 79.3%, DCR was 100%, mDOR was 9.9 months; mPFS was 13.04 months, with a 12-month PFS rate of 54.3%.
- In the CPS≥1 subgroup, the ORR was 72.2%, DCR was 100%, mDOR was 12.2 months; mPFS was 15.9 months, with a 12-month PFS rate of 63.8%.
- Overall survival (OS) data remains immature.
- The combination therapy showed a favorable safety profile. No treatment-related adverse events (TRAEs) resulted in treatment discontinuation or death, and the most common TRAEs were predominantly grade 1-2.
Forward-Looking Statement of Akeso, Inc.
This announcement by Akeso, Inc. (9926.HK, “Akeso”) includes “forward-looking statements.” These statements represent the current views and expectations of Akeso’s management and are subject to significant risks and uncertainties. They are not intended to serve as a basis for any investment decision or for purchasing Akeso securities. There is no guarantee that the drug candidate(s) mentioned in this announcement or other pipeline candidates will secure the necessary regulatory approvals or achieve commercial success. Should underlying assumptions prove incorrect or risks materialize, actual results could differ significantly from those expressed in the forward-looking statements.
Risks and uncertainties include, but are not limited to: general industry conditions and competition; broader economic factors such as interest rate and currency fluctuations; the impact of pharmaceutical regulations and healthcare laws in China, the United States, and other countries; a global trend towards healthcare cost containment; technological advances and new patents obtained by competitors; the inherent challenges of new product development, including regulatory approval; Akeso’s ability to forecast future market conditions accurately; potential manufacturing issues or delays; financial instability in international economies and sovereign risk; reliance on the strength of Akeso’s patents and other intellectual property protections; and exposure to legal disputes, including patent litigation, and regulatory actions.
Except as required by law, Akeso assumes no obligation to update these forward-looking statements to reflect subsequent events or circumstances.
About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative biological medicines that are first or best-in-class globally. Established in 2012, the company has built a unique, integrated R&D innovation system centered on its comprehensive end-to-end drug development platform (ACE Platform) and bispecific antibody technology (Tetrabody), complemented by a GMP-compliant manufacturing system and an advanced commercial operation. Akeso has grown into a globally competitive biopharmaceutical company focused on innovative solutions. With its fully integrated, multi-functional platform, Akeso is developing a robust internal pipeline of over 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic diseases, and other major conditions. Twenty-six of these candidates are in clinical trials, including 15 bispecific/multispecific antibodies and bispecific ADCs. Seven new drugs are already on the market. Through efficient and groundbreaking R&D, Akeso consistently leverages global resources to develop first-in-class and best-in-class therapeutics, aims to provide affordable antibody treatments to patients worldwide, and strives to create lasting commercial and social value as a global biopharmaceutical leader.
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SOURCE Akeso, Inc.