SBP GROUP(01177.HK): HER2 Bispecific ADC TQB2102 Receives Third CDE Breakthrough Therapy Designation for HER2-Low

NewTimeSpace News: On August 3, 2026, Sino Biopharmaceutical Limited (01177.HK) issued a voluntary announcement disclosing that TQB2102, a Category 1 innovative drug self-developed by its subsidiary Chia Tai Tianqing (CTTQ) and a HER2 bispecific antibody-drug conjugate (ADC), has been included in the CDE Breakthrough Therapy Designation list for the treatment of unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) adult breast cancer in patients who have not received chemotherapy in the recurrent or metastatic setting. This marks the third BTD granted to the product, following prior designations for neoadjuvant treatment of HER2-positive early breast cancer and HER2 IHC 3+ advanced colorectal cancer.

TQB2102 features biparatopic targeting, cleavable linker, and drug-to-antibody ratio (DAR) optimization design. The Phase Ib study results presented at ASCO 2025 demonstrated an overall objective response rate (ORR) of 53.4% in HER2-low advanced breast cancer (median of 4 prior lines of therapy), reaching 58.3% in the target dose cohort. Notably, 44.4% of patients who progressed on prior ADC therapy still achieved a response. Approximately 45%–55% of breast cancer patients in China are HER2-low, with existing palliative chemotherapy offering limited clinical benefit and significant toxicity, underscoring substantial unmet medical needs.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.