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]
乐普生物-B(02157.HK)美佑恒(注射用维贝柯妥塔单抗)在中国获批上市