Ivonescimab positioned to reshape China’s TNBC market, says GlobalData

Chinese biotech Akeso (HKEX: 9926) has secured Breakthrough Therapy Designation for Idafang (ivonescimab) in triple-negative breast cancer, positioning the bispecific antibody to become China’s first next-generation immuno-oncology option in the first-line setting. The Phase III HARMONi BC1/AK112 study is due to complete in December 2026.

Ivonescimab targets PD-1 and VEGF-A to stimulate immune activity and block angiogenesis. In a Phase II study with chemotherapy, it achieved an objective response rate close to 79% and disease control in all patients, with progression-free survival around nine months and manageable side effects. GlobalData says the data reinforce its clinical promise.

China’s treatment landscape features checkpoint inhibitors Keytruda (pembrolizumab) and Tuoyi (toripalimab) for first-line use, while antibody drug conjugates Trodelvy (sacituzumab govitecan) and Giatelai (sacituzumab tirumotecan) are used in later lines. German biotech BioNTech (Nasdaq: BNTX) is also competing with Phase III bispecific candidate pumitamig.