SINO BIOPHARM (01177) announced that the Group's self-developed Class 1 innovative drug, TQB2102, a HER2-targeting bispecific antibody-drug conjugate, has completed patient enrollment for a Phase III clinical trial. The trial, designated TQB2102-III-01, is a randomized, open-label, parallel-controlled study evaluating the efficacy and safety of TQB2102 injection compared to investigator-selected chemotherapy in patients with HER2-low expressing recurrent or metastatic breast cancer.
TQB2102 is a novel HER2-targeting bispecific ADC developed by the Group. It incorporates three core technological innovations designed to achieve an optimal balance between efficacy and safety. The drug features a bispecific design that targets two distinct domains of the HER2 receptor, enhancing tumor cell selectivity and drug internalization. It utilizes a cleavable linker that efficiently releases the cytotoxic payload and exhibits a bystander effect, enabling the elimination of neighboring heterogeneous tumor cells. Furthermore, the drug-to-antibody ratio is optimized and stabilized between 5.8 and 6.0, and it is conjugated with a Topoisomerase I inhibitor payload, which aims to increase efficacy while reducing toxicity.
The combination of these technologies is intended to overcome limitations associated with traditional HER2 monoclonal antibodies and single-target ADCs, demonstrating significant potential for treating HER2-low expressing tumors. At the 2025 American Society of Clinical Oncology annual meeting, the Group presented Phase Ib clinical results for TQB2102 in HER2-low advanced breast cancer, showing favorable efficacy and safety. The objective response rate was 53.4% in heavily pre-treated patients, with a rate of 58.3% observed in the 7.5mg/kg dose group. Notably, a response rate of 44.4% was seen even in patients who had previously progressed after ADC therapy. The safety profile was manageable, with the most common grade 3 or higher treatment-related adverse events including neutropenia, leukopenia, anemia, and hypokalemia.
In the field of breast cancer treatment, the Group has developed a comprehensive portfolio addressing various molecular subtypes, including HER2-positive, HER2-low, HR-positive/HER2-negative, and triple-negative breast cancer. The pipeline systematically covers the entire treatment journey from neoadjuvant and first-line therapy to later-line and adjuvant settings, aiming to provide new treatment options for a broader patient population.
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