美佑恒®(注射用维贝柯妥塔单抗)在既往经治过二线及以上系统性化疗及PD-(L)1抑制剂失败后的患者中 显示出临床意义的疗效优势，同时安全性可控。美佑恒®(注射用维贝柯妥塔单抗)用于治疗R/MNPC的 关键注册性临床研究结果于2025年美国临床肿瘤学会年会上以"重磅研究摘要(LBA)"形式公布，并于会 上作口头报告。 此外，美佑恒®(注射用维贝柯妥塔单抗)与普佑恒(普特利单抗注射液)的联合疗法呈现显著且持久的临 床效益，在该联用治疗的II期临床试验中，针对免疫治疗及铂类化疗失败的患者中实现了迄今为止最高 的确认客观缓解率(cORR)(73.3%，95%CI:54.1-87.7)及最长的无进展生存期(mPFS)(10.9m，95%CI:6.6- 15.4)，有望为抗PD-(L)1及铂类化疗失败的R/MNPC患者提供更为有效的治疗选择。上述数据已在2025 年欧洲肿瘤内科学会年会上公布。 格隆汇10月30日丨乐普生物-B(02157.HK)公告，董事会欣然宣布国家药品监督管理局("国家药监局")近 期批准候选药物美佑恒®(注射用维贝柯妥塔单抗)在中国的上市申请，该药物为公司自主研发的一种表 皮生长因子受体("EGF ...

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]