Sino Biopharm’s TQB2102 gets breakthrough status for advanced colorectal cancer

Sino Biopharmaceutical Limited announced its independently developed national Class 1 new drug, TQB2102 “HER2 bispecific antibody-drug conjugate (ADC)” for injection, has been included in the Breakthrough Therapeutic Designation (BTD) process by China’s Center for Drug Evaluation (CDE). This designation is for the treatment of HER2 IHC 3+ advanced colorectal cancer that has failed prior oxaliplatin, irinotecan, and fluorouracil-based regimens. This inclusion is expected to accelerate the approval process for TQB2102.

TQB2102 is a bispecific ADC targeting dual non-overlapping HER2 protein epitopes (ECD2 and ECD4). Preliminary data from a Phase I clinical study, presented at the 2025 ASCO Annual Meeting, showed an objective response rate (ORR) of 34.8% in HER2-high expression (HER2 IHC 3+) colorectal cancer. As of October 1, 2024, the study had enrolled 181 patients with advanced solid tumors, demonstrating manageable safety.

The inclusion of TQB2102 in the BTD process addresses an urgent clinical need for highly effective treatment regimens in advanced colorectal cancer. Existing third-line options offer limited efficacy, with ORR ranging from 1.0% to 2.0%, progression-free survival of 1.9 to 3.7 months, and overall survival of 6.4 to 7.4 months.