Core Insights - The National Medical Products Administration of China has approved the listing application for the candidate drug Meiyouheng® (Injection Vebecotamab) developed by the company, which is an innovative antibody-drug conjugate targeting the epidermal growth factor receptor (EGFR) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/MNPC) [1] Group 1: Drug Development and Approval - Meiyouheng® is an ADC composed of an EGFR-targeting monoclonal antibody linked to a potent microtubule inhibitor, demonstrating high specificity for tumor cells expressing EGFR, which is prevalent in various malignancies [1] - The drug targets EGFR, which is expressed in 89% of advanced nasopharyngeal carcinoma cases, making it a significant target for cancer treatment [1] Group 2: Clinical Efficacy and Safety - Meiyouheng® has shown clinically meaningful efficacy advantages in patients who have failed second-line systemic chemotherapy and PD-(L)1 inhibitors, with manageable safety profiles [2] - In a Phase II clinical trial, the combination therapy of Meiyouheng® with Putiheng (Injection Putilizumab) achieved the highest confirmed objective response rate (cORR) of 73.3% and the longest median progression-free survival (mPFS) of 10.9 months in patients who failed immunotherapy and platinum-based chemotherapy [2]

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]