CSPC's TQB2102 Meets Primary Endpoint in Phase III Breast Cancer Trial, Set for Filing and Cipla Licensing

Chia Tai Tianqing, a subsidiary of China Biopharmaceutical Holdings, has completed a pre-specified interim analysis of its Phase III clinical study of TQB2102, an investigational HER2 bispecific antibody-drug conjugate (ADC) targeting both the ECD II and ECD IV domains of HER2, in patients with HER2-low relapsed or metastatic breast cancer. The independent data monitoring committee determined that the study met its pre-specified primary and key secondary endpoints. This is the first global Phase III study to demonstrate success of a HER2 bispecific ADC in HER2-low breast cancer. Chia Tai Tianqing has received written agreement from the Center for Drug Evaluation of China's National Medical Products Administration and will submit a marketing application for this indication in the near future.

The TQB2102-III-01 study is a randomized, open-label, active-controlled, multicenter Phase III trial designed to evaluate the efficacy and safety of TQB2102 compared with investigator's choice of chemotherapy in HER2-low relapsed or metastatic breast cancer. The interim analysis showed that, compared with the investigator's choice of chemotherapy, the TQB2102 arm significantly reduced the risk of disease progression or death, with a statistically and clinically meaningful improvement in progression-free survival.

Chia Tai Tianqing is currently advancing multiple Phase III studies of TQB2102 across indications including first-line treatment of HER2-low breast cancer without prior chemotherapy, HER2-positive advanced breast cancer after failure of anti-HER2 therapy, neoadjuvant treatment of HER2-positive breast cancer, first-line treatment of HER2-positive advanced breast cancer, later-line treatment of HER2-positive advanced biliary tract cancer, and previously treated HER2-positive advanced colorectal cancer.

On August 31, Chia Tai Tianqing entered into an exclusive licensing and supply agreement with Cipla Limited, granting Cipla exclusive rights to develop and commercialize TQB2102 in India, South Africa, and five other emerging markets. Cipla will be responsible for local clinical development, regulatory filings, and commercialization in the licensed territories, while Chia Tai Tianqing will handle manufacturing and supply. China Biopharmaceutical Holdings is entitled to upfront payments, potential development, regulatory, and sales milestone payments of up to $123 million, as well as double-digit royalties based on TQB2102 sales.