SBP GROUP (01177): TQB6411 "EGFR/C-MET ADC" will announce Phase I clinical data at ASCO in 2026.

SBP GROUP (01177) announced that the affiliated company Zhengdadianqing Pharmaceutical Group Co., Ltd. (Zhengdadianqing) independently developed the national first-class innovative drug TQB6411 "EGFR/c-Met ADC", which was presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting for the first-in-human phase I clinical study data in patients with advanced solid tumors. As of December 31, 2025, a total of 26 patients were enrolled in the study (NCT07043751), with a median age of 60 years (range 33-75 years), and 46.2% were females. Enrolled patients were all advanced malignant tumor patients who had failed standard treatment or were intolerant, including 21 cases of non-small cell lung cancer, 3 cases of esophageal cancer, and 2 cases of colorectal cancer, all of whom had received at least first-line systemic treatment prior. As of January 13, 2026, the dose has escalated from the initial dose of 0.8 mg/kg to 6.6 mg/kg in 5 dose levels without dose-limiting toxicity (DLT). In the 4 mg/kg dose group, among 9 evaluable patients who had at least one imaging evaluation, 4 achieved partial response (PR), the objective response rate (ORR) was 44.4%, and the disease control rate (DCR) reached 100%. Specifically, in the 5.3 mg/kg group, one patient with second-line treated NSCLC had a 55.2% reduction in target lesions from baseline; in the 4.0 mg/kg group, two patients with 3 lines of treatment for NSCLC had reductions of 30.4% and 48.1% in target lesions, demonstrating excellent efficacy in heavily treated advanced patients. In terms of safety, the incidence of grade 3 treatment-related adverse events (TRAE) in the 23 patients followed-up for at least 21 days was only 21.7%, and no grade 4 TRAE was observed in the entire group. There were no occurrences of interstitial lung disease (ILD) during the study. The study indicates that TQB6411 exhibits good safety characteristics at effective doses, particularly with low hematologic toxicity. TQB6411 has higher affinity for the c-Met end than the EGFR end (efficacy ratio of 1:2), enhancing its killing effect on c-Met overexpressing tumor cells while reducing skin toxicity and other adverse reactions associated with targeting EGFR. Overexpression of epidermal growth factor receptor (EGFR) and hepatocyte growth factor receptor (c-Met) is common in various solid tumors such as non-small cell lung cancer, esophageal cancer, and colorectal cancer. When the EGFR pathway is blocked by drugs, tumor cells often activate the c-Met pathway to evade inhibition, a mechanism considered one of the core mechanisms of resistance to existing EGFR targeted therapies. As the first global EGFR/c-Met ADC to be publicized with clinical data, TQB6411 has a mature target combination and affinity design biased towards the c-Met end, establishing a competitive advantage while reducing R&D risk. The phase I clinical data released in this announcement shows that the drug can induce tumor shrinkage at low doses in heavily treated advanced patients, with good safety characteristics. Based on this, the group is accelerating the clinical development of this drug.