Sino Biopharmaceutical announces NDA acceptance for TQB2102 in HER2-low Breast cancer in China

CAR-T Digest - August 2020

16 September 2026: Sino Biopharmaceutical announces NDA acceptance for TQB2102 in HER2-low Breast cancer in China

Sino Biopharmaceutical has received China CDE acceptance of the NDA for TQB2102 in adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH−) breast cancer who have not received prior chemotherapy in the relapsed/metastatic setting, following a prior Breakthrough Therapy Designation for this indication

The NDA is supported by the phase 3 TQB2102-III-01 study, which enrolled 543 patients and met its prespecified primary and key secondary endpoints at interim analysis; compared with investigator’s-choice chemotherapy, TQB2102 significantly reduced the risk of disease progression or death and delivered a statistically significant and clinically meaningful improvement in PFS
The NDA addresses an unmet need in HER2-low metastatic breast cancer, where treatment options remain limited and tumor heterogeneity and low HER2 expression can constrain the activity of conventional HER2-targeted approaches
TQB2102 is a HER2 dual-epitope bispecific ADC featuring an asymmetric antibody that binds both HER2 ECD II and ECD IV, an enzyme-cleavable linker designed to enable a bystander effect, a Topo I inhibitor payload, and an optimized DAR of approximately 5.8-6.0, supporting activity across heterogeneous HER2-low tumors
Strategically, the NDA advances TQB2102 toward its first potential approval while the asset is being evaluated across multiple phase 3 settings spanning HER2-low and HER2-positive breast cancer and HER2-positive biliary tract and colorectal cancers