Akeso announced that its first-in-class bispecific antibody, Ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for first-line treatment of Triple-Negative Breast Cancer (TNBC) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) from China's National Medical Products Administration (NMPA).

The Phase III multicentre, randomised, double-blind clinical trial (HARMONi-BC1/AK112-308) for this combination therapy is ongoing in China. The BTD designation is expected to further expedite the clinical development and regulatory approval process of Ivonescimab for the treatment of TNBC. This marks the fourth BTD granted by the CDE for Ivonescimab. The previous three designations include the following:

• Ivonescimab, combined with chemotherapy for locally advanced or metastatic NSCLC resistant to EGFR-TKI therapy, which has now been approved for marketing in China and added to China's National Reimbursement Drug List.
• First-line treatment of PD-L1-positive locally advanced or metastatic NSCLC, which has also been approved for marketing in China.
• Ivonescimab, combined with docetaxel, for locally advanced or metastatic NSCLC patients who have failed previous PD-1/L1 inhibitors and platinum-based chemotherapy. The Phase III clinical trial for this indication in China is currently ongoing.

Receiving four BTDs affirms Ivonescimab's substantial clinical benefit across multiple major cancer types and reinforces Akeso's commitment to addressing critical unmet medical needs. The therapy is currently advancing in 14 Phase III clinical trials worldwide, including four international multicentre studies. These studies, backed by repeated regulatory recognition, position Ivonescimab to deliver transformative, life-saving outcomes for patients worldwide.