Sino Biopharmaceutical (01177): TQB2102 "HER2 Bispecific ADC" included in breakthrough therapy program.

SINO BIOPHARM (01177) announced that the group's independently developed national class 1 new drug injection TQB2102 "HER2 dual specific antibody drug conjugate (ADC)" has been included in the Breakthrough Therapy Drug (BTD) program by the China Food and Drug Administration Drug Evaluation Center (CDE) for the treatment of advanced colorectal cancer with HER2 IHC 3+ that has failed treatment with oxaliplatin, irinotecan, and fluoropyrimidine drugs. TQB2102 is a dual antibody ADC drug that targets both non-overlapping sites of the HER2 protein ECD2 and ECD4, showing strong advantages in the treatment of colon cancer. The group presented preliminary data from the phase I clinical study of TQB2102 at the 2025 American Society of Clinical Oncology (ASCO) annual meeting. As of October 1, 2024, the study included a total of 181 treated patients with advanced solid tumors, including HER2-positive and HER2 low expression patients. The study results showed an objective response rate (ORR) of 34.8% in HER2 high expression (HER2 immunohistochemistry (IHC) 3+) colorectal cancer. The latest analysis indicates that the efficacy of TQB2102 in HER2 IHC 3+ advanced colorectal cancer continues to improve with prolonged treatment time, while maintaining overall safety. Currently, there is still a lack of specific targeted treatment options for HER2 overexpressing advanced colorectal cancer. According to the Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of colorectal cancer, first and second line treatments are mainly based on oxaliplatin, irinotecan, and fluoropyrimidine chemotherapy, with or without combination with anti-angiogenic drugs. After failure of second line standard treatment, third line treatment options are extremely limited, with insufficient efficacy: ORR only 1.0%-2.0%, progression-free survival (PFS) 1.9-3.7 months, and overall survival (OS) 6.4-7.4 months. There is a pressing need for highly effective treatment options, urgently requiring breakthroughs in more effective treatment strategies. The inclusion of TQB2102 in the BTD program will accelerate its market approval process, potentially benefiting patients sooner and reshaping the treatment landscape for HER2 IHC 3+ colorectal cancer.