SBP GROUP (01177.HK): TQB2102 Data at ESMO; Phase III Breast Cancer Median PFS 16.4 Months

NewTimeSpace News: On 26 October 2026, Sino Biopharmaceutical Limited (stock code: 1177) announced that TQB2102, a Class 1 innovative HER2 biparatopic antibody-drug conjugate independently developed by its subsidiary Chia Tai Tianqing, presented two sets of clinical data at the 2026 ESMO Congress, selected as a proffered paper (LBA) and a rapid oral presentation respectively.

In breast cancer, the Phase III APEX-Breast01 study enrolled 543 patients with HER2-low recurrent or metastatic breast cancer who had not received prior chemotherapy in the advanced setting (269 in the TQB2102 arm and 274 in the chemotherapy arm), with the primary endpoint being progression-free survival assessed by blinded independent review in the HR-positive/HER2-low population. As at 31 May 2026, median PFS was 16.4 months versus 5.5 months in both that population and the overall HER2-low population, with a hazard ratio of 0.29 (P<0.0001). The objective response rate was 68.8% versus 31.0%, median duration of response 15.0 versus 7.1 months and the clinical benefit rate 78.8% versus 44.2%; overall survival hazard ratios were 0.47 and 0.44 in the two populations.

Grade 3 or above treatment-related adverse events were mainly decreased neutrophil count (30.1% versus 23.3%) and decreased white blood cell count (21.6% versus 14.0%); permanent discontinuation due to adverse events was 1.5% in both arms and fatal treatment-related events 0.4% in both. Treatment-related interstitial lung disease occurred in 2.2% of the TQB2102 arm, including 1.1% grade 3 or above, with no related deaths.

In gastric cancer, the Phase II TQB2102-II-04 study enrolled 86 patients with HER2-positive advanced gastric/gastroesophageal junction cancer; objective response rates in the doublet cohort A and triplet cohorts B and C were 69.6%, 75.8% and 95.8%, disease control rates were 95.7%, 100% and 100%, and grade 3 or above treatment-related adverse events occurred in 60.0%, 78.4% and 58.3%. A dose of 6 mg/kg has been selected for the subsequent Phase III study. In September 2026, the NDA for TQB2102 in HER2-low breast cancer was accepted by the NMPA's Centre for Drug Evaluation.