Akeso Inc’s Idafang (ivonescimab) received Breakthrough Therapy Designation (BTD) in China in November 2025 for triple-negative breast cancer (TNBC). As a result, ivonescimab, an investigational monoclonal antibody (mAb) currently in a Phase III trial, is positioned to become the first potential bispecific next-generation immuno-oncology (IO) agent as first-line treatment for TNBC in China, according to GlobalData, a leading data and analytics company.

Ivonescimab targets both PD-1 and VEGF-A, providing immune activation and angiogenesis blockade. In a Phase II trial combining ivonescimab with chemotherapy, the treatment demonstrated an objective response rate of approximately 78.8% and a 100% disease control rate, with a median progression-free survival of 9.3 months and manageable adverse events. The Phase III HARMONi BC1/AK112 trial for TNBC is expected to be completed by December 2026.

According to GlobalData’s Pharmaceutical Intelligence Center, the current TNBC treatment landscape in China includes checkpoint inhibitors such as Keytruda (pembrolizumab) and Tuoyi (toripalimab) as first-line therapies, along with antibody drug conjugates (ADCs) like Trodelvy (sacituzumab govitecan) and Giatelai (sacituzumab tirumotecan) for second and later lines of therapy. Additionally, BioNTech’s pumitamig, a Phase III bispecific agent, is also competing in this area.

China now leads TNBC IO innovation ahead of the US, with two marketed I-O therapies (Keytruda and Tuoyi) and two drugs (ivonescimab and pumitamig) in Phase III for TNBC. In the US, Keytruda and Keytruda Qlex are approved IO therapies, while Immutep Ltd’s eftilagimod alfa, a fusion protein, and Pumitamig are in Phase III for TNBC.

Chilamula Srija, Pharma Analyst at GlobalData, comments: “TNBC is one of the most aggressive breast cancer subtypes, typically associated with poor prognosis and limited targeted therapy options. A positive outcome in the Phase III trial for ivonescimab as a first-line treatment could significantly improve clinical outcomes for patients.”

Ivonescimab has previously received three BTDs for non-small cell lung cancer (NSCLC). In May 2024, Akeso obtained its first NMPA approval for ivonescimab for EGFR TKI-resistant NSCLC, followed by approval for first-line PD-L1-positive advanced NSCLC. It has also shown positive Phase III overall survival data and head-to-head results compared to pembrolizumab.

Chilamula concludes: “Despite advances in oncology, TNBC remains a significant clinical challenge due to difficulty in targeting it, as it lacks expression of estrogen receptors, progesterone receptors, and HER2. This underscores the need for novel options, such as ivonescimab. Additionally, the advantages of prior NSCLC approval and National Reimbursement Drug List listing present an opportunity for Akeso to compete with existing therapies and late-stage pipeline drugs in penetrating the TNBC market in China.”