SINO BIOPHARM (01177): "TQB6411 (EGFR/c-Met dual-targeted ADC)" clinical trial application accepted by CDE.

SINO BIOPHARM (01177) announced that its independently developed "TQB6411 (EGFR/c-Met dual antibody ADC)" has been submitted for clinical trial application to the China National Medical Products Administration's Center for Drug Evaluation (CDE) and has been accepted. Epidermal growth factor receptor (EGFR) and c-Met are two important driver genes for lung cancer, both belonging to receptor tyrosine kinases with synergistic downstream signaling pathways. Targeting both EGFR and c-Met can simultaneously block the PI3K/AKT/mTOR and Ras/Raf/Mek dual pathways, enhancing the anti-tumor effect by inhibiting compensatory activation. TQB6411 is an antibody-drug conjugate (ADC) targeting EGFR and c-Met, administered intravenously to block the EGFR and c-Met signaling pathways on the surface of tumor cells. The ADC is then internalized and transported to lysosomes, where the linker is cleaved by enzymes to release DDDXD, causing DNA damage and cell death. In vitro studies have shown that TQB6411 has antibody-dependent cell-mediated cytotoxicity (ADCC) and DDDXD can kill neighboring tumor cells through a bystander effect. TQB6411 has completed extensive pharmacology, pharmacokinetics, and safety validation, with a clear anti-tumor mechanism. It shows significant tumor-inhibiting effects on cells with different expressions and resistance to EGFR and c-Met, with in vitro activity comparable to the same target drug AZD9592 and superior in vivo activity. In addition to TQB6411, the company also has TQB2922 (EGFR/c-Met dual antibody) in the EGFR and c-Met target area, which started Phase I clinical trials in December 2023, TQB3002 (fourth-generation EGFR inhibitor) in Phase I clinical trials approved in the US, and FHND9041 (third-generation EGFR inhibitor) in Phase III clinical trials. The company will accelerate the clinical development process of these products, focusing on unmet global clinical needs to provide patients with better treatment options.