SINO BIOPHARM (01177) announced that its self-developed Class 1 innovative drug TQB2102 injection, a "HER2 bispecific antibody-drug conjugate (ADC)," has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration. The designation is for treating HER2 IHC 3+ advanced colorectal cancer in patients who have failed prior treatment with oxaliplatin, irinotecan, and fluorouracil-based therapies.

TQB2102 is a bispecific ADC drug that simultaneously targets both ECD2 and ECD4 non-overlapping epitopes of the HER2 protein, demonstrating superior efficacy in colorectal cancer treatment through its differentiated design. The company has presented preliminary Phase I clinical study data for TQB2102 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

As of October 1, 2024, the study enrolled 181 patients with pretreated advanced solid tumors, including both HER2-positive and HER2-low expressing cases. The results showed that the objective response rate (ORR) for HER2 high-expressing (HER2 immunohistochemistry (IHC) 3+) colorectal cancer reached 34.8%. Latest analysis indicates that TQB2102's efficacy in HER2 IHC 3+ advanced colorectal cancer continues to improve with extended treatment duration, while maintaining overall safety and tolerability.

Currently, there remains a lack of specific targeted treatment options for HER2-overexpressing advanced colorectal cancer. According to the Chinese Society of Clinical Oncology (CSCO) colorectal cancer treatment guidelines, first- and second-line treatments primarily consist of chemotherapy based on oxaliplatin, irinotecan, and fluorouracil, with or without anti-angiogenic agents. After failure of standard second-line treatment, third-line treatment options are extremely limited with insufficient efficacy: ORR of only 1.0%-2.0%, progression-free survival (PFS) of 1.9-3.7 months, and overall survival (OS) of 6.4-7.4 months.

There is urgent clinical demand for highly effective treatment regimens, with pressing need for more effective therapeutic breakthroughs. The formal inclusion of TQB2102 in BTD will accelerate its market approval process, potentially benefiting patients sooner and reshaping the treatment landscape for HER2 IHC 3+ colorectal cancer.