TQB2102 HER2 bispecific ADC included in the Breakthrough Therapeutic Designation process

CAR-T Digest - August 2020

13 October 2025: TQB2102 HER2 bispecific ADC included in the Breakthrough Therapeutic Designation process

TQB2102, a HER2 bispecific antibody-drug conjugate (ADC) developed by Sino Biopharmaceutical, has been granted Breakthrough Therapeutic Designation (BTD) by China’s CDE for HER2 IHC 3+ advanced colorectal cancer that failed standard chemotherapy
The ADC targets two distinct HER2 epitopes (ECD2 and ECD4), showing a differentiated bispecific design with strong anti-tumor potential
In a Phase I study (181 patients) presented at ASCO 2025, TQB2102 achieved an objective response rate (ORR) of 34.8% in HER2-high (IHC 3+) colorectal cancer, with manageable safety and improving efficacy over time
Current third-line colorectal cancer therapies show only 1-2% ORR and limited survival, highlighting a significant unmet clinical need for effective HER2-targeted options
The BTD designation will expedite development and approval, potentially allowing TQB2102 to reshape treatment for HER2 IHC 3+ advanced colorectal cancer in China