SINO BIOPHARM(01177) 格隆汇·2025-05-27 09:44Core Insights - China Biologic Products (01177.HK) announced preliminary data from the first human Phase I clinical study of TQB2102, a HER2 bispecific antibody-drug conjugate (ADC), presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] Efficacy Summary - The trial included 181 patients with advanced solid tumors who had no standard treatment options as of October 1, 2024, including both HER2-positive and HER2 low-expressing patients [1] - In terms of efficacy, the objective response rate (ORR) for HER2-positive breast cancer in the 6mg/kg and above dose group was 51.3%, while for HER2 low-expressing breast cancer, the ORR was 51.5% [1] - The ORR for HER2 high-expressing (HER2 IHC 3+) colorectal cancer was 34.8%, and for HER2-positive gastric or gastroesophageal junction adenocarcinoma, the ORR was 70% [1] - Among the subgroup of HER2-positive breast cancer patients with brain metastases, the ORR was 70%, with one case achieving complete resolution of intracranial lesions [1] - 31% of breast cancer patients who were resistant to T-DM1/DS-8201 still responded to TQB2102 treatment [1] Safety Summary - In terms of safety, the main ≥3 grade adverse events (AE) in the overall population included neutropenia (21.7%), decreased white blood cell count (10.6%), anemia (8.9%), and decreased platelet count (6.1%) [2] - Notably, only one case (0.55%) of grade 2 interstitial lung disease (ILD) was reported, which is significantly lower than the incidence seen with similar drug DS-8201 (greater than 10%) [2] - TQB2102 has shown significant clinical benefits across multiple advanced malignancies while maintaining a low incidence of ILD, achieving a balance between efficacy and safety [2] - Currently, TQB2102 is undergoing Phase III clinical trials and has the potential to reshape the treatment landscape for HER2 ADCs [2]