Core Insights - The National Medical Products Administration of China has approved the listing application for the candidate drug Meiyouheng (injectable Vebecotuzumab) developed by the company, which is an innovative antibody-drug conjugate targeting epidermal growth factor receptor (EGFR) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/MNPC) [1][2] Company Overview - Meiyouheng is an ADC composed of an EGFR-targeting monoclonal antibody linked to a potent microtubule inhibitor, demonstrating high affinity for tumor cells expressing EGFR, which is a significant target in cancer therapy [1] - The drug targets EGFR, which is highly expressed in various malignancies, including colorectal cancer, lung cancer, and head and neck cancer, with 89% of advanced NPC cases showing EGFR expression [1] Clinical Efficacy - Meiyouheng has shown clinically meaningful efficacy in patients who have failed second-line or higher systemic chemotherapy and PD-(L)1 inhibitors, with controllable safety [2] - Key registration clinical trial results for Meiyouheng in treating R/MNPC will be presented as a "late-breaking abstract" at the 2025 American Society of Clinical Oncology annual meeting [2] - The combination therapy of Meiyouheng with Puyouheng (putilizumab injection) has demonstrated significant and durable clinical benefits, achieving 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