SBP GROUP (01177): New drug marketing application for TQB2102 injection, a "HER2 bispecific epitope bispecific antibody ADC", has been accepted

SBP GROUP (01177) announced that the New Drug Application (NDA) for TQB2102 injection, a Class 1 innovative drug in China independently developed by the Company's subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Chia Tai Tianqing), a "HER2 bispecific epitope bispecific antibody ADC", has been submitted to and accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration, for the treatment of adult patients with unresectable or metastatic HER2-low expression (IHC 1+ or IHC 2+/ISH-) breast cancer who have not received prior chemotherapy in the recurrent or metastatic setting. Previously, this indication was granted Breakthrough Therapy Designation by the CDE. TQB2102 is the world's first HER2 bispecific epitope bispecific antibody ADC to achieve positive results in a Phase III clinical trial for HER2-low expression breast cancer. The TQB2102-III-01 study is a randomized, open-label, active-controlled, multicenter Phase III clinical study that enrolled a total of 543 patients with HER2-low expression breast cancer. According to the assessment by the Independent Data Monitoring Committee (IDMC), the study met the pre-specified primary endpoint and key secondary endpoints at the interim analysis. Compared with investigator-selected chemotherapy regimens, TQB2102 significantly reduced the risk of disease progression or death, with the primary endpoint of progression-free survival (PFS) achieving a statistically significant and clinically meaningful improvement. Detailed data from this study will be presented at an international academic conference in the future. The antibody arm of TQB2102 adopts an asymmetric structural design, enabling simultaneous binding to two different domains of HER2, ECD II and ECD IV, enhancing binding and endocytosis efficiency against tumor cells through bispecific epitope synergy; it also employs an enzyme-cleavable linker to expand the killing range against heterogeneous tumors through a "bystander effect". TQB2102 optimizes the drug-to-antibody ratio (DAR) to approximately 5.8-6.0 and carries a topoisomerase I (Topo I) inhibitor payload, enhancing antitumor activity while maintaining safety. This unique drug design overcomes the limitations of traditional HER2 monoclonal antibodies or single-target ADCs, offering greater potential advantages for the treatment of HER2-low expression tumors. Currently, TQB2102 is advancing multiple Phase III clinical studies covering different HER2 expression levels and multiple tumor types, including HER2-low expression breast cancer, neoadjuvant treatment for HER2-positive breast cancer, first-line and later-line treatment for HER2-positive advanced breast cancer, as well as later-line treatment for HER2-positive biliary tract cancer and colorectal cancer. Among these, three indications have been granted Breakthrough Therapy Designation by the CDE, further demonstrating its broad application potential in the treatment of HER2-expressing solid tumors. In August 2026, the Company announced the entry into an exclusive licensing and supply agreement with Cipla Limited (Cipla) for TQB2102. The Company granted Cipla an exclusive license to develop and commercialize TQB2102 in India, South Africa, and five other emerging markets (the licensed territory). Cipla will be responsible for local clinical development, regulatory filing, and commercialization within the licensed territory, while Chia Tai Tianqing will continue to be responsible for the manufacturing and supply of TQB2102. To date, TQB2102 has entered into two regional licensing collaborations, bringing the Company a cumulative total of approximately US$30 million in upfront and milestone payments, fully demonstrating the commercial value of this asset and the Company's robust regional collaboration layout.