Chinese biopharmaceutical company Akeso (HK:9926) announced on Sunday that it has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for 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).

HARMONi-BC1/AK112-308, the Phase III multicentre, randomised, double-blind clinical trial for this combination therapy, is ongoing in China. BTD designation is expected to further accelerate the clinical development and regulatory approval process for ivonescimab for the treatment of TNBC.

The company says that this fourth Breakthrough Therapy Designations affirms the product's substantial clinical benefit across multiple major cancer types and reinforces its commitment to dealing with critical unmet medical requirements.

Ivonescimab is currently advancing in 14 Phase III clinical trials worldwide, including four international multicentre studies.