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中国生物制药(01177):“TQB6411 (EGFR/c-Met双抗ADC)”临床试验申请获CDE受理
01177SINO BIOPHARM(01177) 智通财经网·2025-04-03 15:01

Core Viewpoint - China Biopharmaceutical has submitted a clinical trial application for its self-developed drug TQB6411 to the National Medical Products Administration (NMPA) and has received acceptance [1] Group 1: Product Development - TQB6411 is an antibody-drug conjugate (ADC) targeting EGFR and c-Met, which are key drivers of lung cancer, and it works by blocking the signaling pathways associated with these receptors [1] - The drug has demonstrated significant anti-tumor effects in vitro, showing antibody-dependent cell-mediated cytotoxicity (ADCC) and the ability to kill adjacent tumor cells through a bystander effect [1] - TQB6411 has completed pharmacology, pharmacokinetics, and safety validation, showing clear anti-tumor mechanisms and significant inhibitory effects on EGFR and c-Met positive cells [2] Group 2: Competitive Positioning - The in vivo activity of TQB6411 is significantly superior to that of the comparable drug AZD9592, while its in vitro activity is comparable [2] - In addition to TQB6411, the company has other products in the EGFR and c-Met target area, including TQB2922, which has entered Phase I clinical trials, and TQB3002, a fourth-generation EGFR inhibitor that has been approved for clinical trials in the U.S. [2] - The company aims to accelerate the clinical development of these products to address unmet clinical needs globally and provide better treatment options for patients [2]