SBP GROUP (01177) has announced that its subsidiary, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ), has received a third breakthrough therapy designation from the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This designation for TQB2102, a novel HER2 bispecific antibody-drug conjugate, is specifically for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have not yet received chemotherapy in the recurrent or metastatic disease setting.
This is the third breakthrough therapy designation granted to TQB2102, following earlier recognitions for neoadjuvant treatment of HER2-positive early-stage breast cancer and for HER2 IHC 3+ advanced colorectal cancer. This latest designation underscores the drug's broad potential across various HER2-expressing solid tumors.
TQB2102 is a next-generation HER2 bispecific ADC developed by the group. Its design incorporates three key technological breakthroughs to achieve a balanced optimization of efficacy and safety. First, the antibody adopts an asymmetric structural design, enabling simultaneous binding to the ECD II and IV domains of HER2, which significantly enhances tumor selectivity and internalization efficiency, thereby boosting anti-tumor activity. Second, a cleavable linker is used, allowing for efficient enzymatic cleavage and toxin release while preserving a "bystander effect" to expand the killing range of heterogeneous tumors. Third, the drug-to-antibody ratio is optimized to a range of 5.8–6.0, paired with a topoisomerase I inhibitor payload, to fine-tune the balance between anti-tumor efficacy and toxicity.
These differentiated design features overcome the limitations of traditional HER2 monoclonal antibodies or single-target ADCs. The dual-epitope binding model enhances receptor cross-linking and internalization, offering a clear and distinct advantage in treating patients with HER2-low expression.
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