TQB2102 receives BTD from the CDE for patients with unresectable or metastatic HER2-low Breast cancer

CAR-T Digest - August 2020

03 August 2026: TQB2102 receives BTD from the CDE for patients with unresectable or metastatic HER2-low Breast cancer

Sino Biopharmaceutical’s next-generation HER2 bispecific ADC TQB2102 has received its third Breakthrough Therapy Designation from China’s CDE for adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have not received chemotherapy in the relapsed/metastatic setting, following prior designations in HER2-positive early breast cancer and HER2 IHC 3+ advanced colorectal cancer

The BTD is supported by the phase 3 TQB2102-III-01 study, a randomized, open-label trial evaluating TQB2102 versus investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer who have not received chemotherapy in the metastatic setting
The designation addresses a substantial unmet need in HER2-low breast cancer, which accounts for approximately 45%–55% of breast cancers and has historically relied largely on palliative chemotherapy, particularly after endocrine therapy resistance in HR-positive disease or in HR-negative/TNBC patients
TQB2102 is a dual-epitope HER2 bispecific ADC that simultaneously binds the ECD II and ECD IV domains of HER2 to enhance tumor selectivity and internalization. It uses an enzyme-cleavable linker and a topoisomerase I inhibitor payload with an optimized DAR of 5.86-6, enabling payload release and a bystander effect while balancing efficacy and toxicity
Strategically, the third BTD further validates TQB2102’s broad potential across HER2-expressing tumors, while its ongoing phase 3 program spans HER2-low and HER2-positive breast cancer, biliary tract cancer and colorectal cancer, supporting Sino Biopharmaceutical’s strategy to establish the asset as a differentiated next-generation HER2 ADC