China Biopharmaceutical (01177): TQB2102 injection “HER2 double epitope dual antibody ADC” new drug application accepted

Zhitong Finance App News, China Biopharmaceutical (01177) announced that the national Class 1 innovative drug TQB2102 injection “HER2 bi-epitopic dual antibody ADC” independently developed by the Group's subsidiary, Zhengda Tianqing Pharmaceutical Group Co., Ltd. (Zhengda Tianqing) has submitted a new drug marketing application to the China National Drug Administration Drug Evaluation Center (CDE) and has been accepted for use in the case of unresectable or metastatic HER2 low expression (IHC 1+ or IHC-ISH 2ISH) that has not received chemotherapy in the recurrent or metastatic stage of the disease) adult mammary gland cancer patients. Previously, this indication was included by CDE as a breakthrough treatment variety.

TQB2102 is the world's first HER2 bi-epitopic dual antibody ADC to achieve positive results in stage III clinical trials with low HER2 expression breast cancer. The TQB2102-III-01 study was a randomized, open, positive drug control, multicenter phase III clinical study. A total of 543 cases of breast cancer with low HER2 expression were included. As assessed by the Independent Data Monitoring Committee (IDMC), the study had reached the primary and key secondary endpoints anticipated by the programme during mid-term analysis. Compared with the chemotherapy regimen selected by the researchers, TQB2102 significantly reduced the risk of disease progression or death, and the main endpoint progression-free survival (PFS) achieved significant improvements in statistically significant and clinically significant improvements. Detailed data from the study will be presented later at an international academic conference.

The antibody end of TQB2102 uses an asymmetric structural design, which can simultaneously combine the ECD II and ECD IV domains of HER2 to enhance binding and endocytosis efficiency to tumor cells through double epitope synergy; at the same time, it uses enzymatic ligators to expand the range of killing of heterogeneous tumors through the “bystander effect”. TQB2102 optimizes the drug-antibody ratio (DAR) to approximately 5.8-6.0, and is loaded with topoisomerase I (Topo I) inhibitors to improve anti-tumor activity while taking safety into account. This unique drug design breaks through the limitations of traditional HER2 monoclonal antibodies or single-target ADCs, and has potential advantages for treating tumors with low HER2 expression.

Currently, TQB2102 is advancing a number of phase III clinical studies, covering different HER2 expression levels and multiple tumors, including HER2 low-expression breast cancer, new adjuvant treatment for HER2-positive breast cancer, first-line and late-line treatment for advanced HER2-positive breast cancer, and late-line treatment for HER2-positive biliary tract cancer and colorectal cancer. Among them, 3 indications have been included by CDE as a breakthrough treatment, further demonstrating its potential for wide application in the treatment of HER2-expressing solid tumors.

In August 2026, the Group announced an exclusive licensing and supply agreement with Cipla Limited (Cipla) for TQB2102. The Group has granted Cipla an exclusive license to develop and commercialize TQB2102 in India, South Africa and five other emerging markets (authorized regions). Cipla will be responsible for local clinical development, registration and commercialization within the authorized region, and Chia Tai Tianqing will continue to be responsible for the production and supply of TQB2102. Up to now, TQB2102 has reached two regional licensing agreements, and has brought a total of about 30 million US dollars in down payments and milestone payments to the Group, which fully reflects the commercial value of this asset and also shows the Group's steady regional cooperation layout.