辉瑞CD47遇挫，莫得纳mRNA流感疫苗数据积极、信诺维推进ADC

医药经济报2025-07-02

1. 患者招募受阻，辉瑞终止一CD47药物试验日前，行业媒体Endpoints News报道，辉瑞宣布终止CD47药物maplirpacept联合化疗药来那度胺用于复发或难治性弥漫大B细胞淋巴瘤（DLBCL）患者的Ⅱ期临床试验。辉瑞发言人表示，试验终止的原因是“招募困难，并非出于安全性或疗效方面的担忧”。发言人还表示，公司仍在推进该药物用于治疗包括多发性骨髓瘤在内的多种血液恶性肿瘤的研究。此次试验...

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莫得纳季节性流感mRNA疫苗Ⅲ期研究数据积极6月30日，莫得纳宣布，其在研季节性流感疫苗mRNA-1010在Ⅲ期临床试验（P304）中取得积极结果。该研究评估了mRNA-1010相较于一款已获批的标准剂量季节性流感疫苗在50岁及以上成年人中的相对疫苗有效性（rVE）。研究结果显示，mRNA-1010达到了研究方案中预设的最严格优效性判定标准，在整体人群中的rVE为26.6%。此外，mRNA-1010对疫苗所涵盖的每一种流感毒株也表现出较强的相对有效性：A/H1N1毒株的rVE为29.6%，A/H3N2为22.2%，B/Victoria谱系为29.1%。亚组分析显示，该疫苗在不同年龄段、风险因素水平及既往接种流感疫苗与否的受试者中均有一致且显著的有效性。此外，mRNA-1010的安全性和耐受性与此前Ⅲ期研究报告结果一致。大多数受试者的不良反应为轻度，最常见的局部反应是注射部位疼痛。该试验共在11个国家招募了40805名50岁及以上的成年患者，受试者被随机分配接受一次性接种mRNA-1010或一款已获批的标准剂量流感疫苗，随访中位时间为6个月。3. 信诺维ADC开展胰腺癌Ⅲ期临床试验近日，药物临床试验登记与信息公示平台显示，信诺维登记了旗下抗体药物偶联物（ADC）XNW28012针对胰腺癌的Ⅲ期临床试验。据悉，该试验为随机、双盲、多中心试验，旨在比较XNW28012联合最佳支持治疗与安慰剂联合最佳支持治疗在转移性胰腺癌受试者中的总生存期（OS）。XNW28012 基于宜联生物TMALIN平台设计，实信诺维在研第二款ADC，采用可在肿瘤微环境中激活的三肽连接子偶联新型异构酶抑制剂毒素YL0014，载药比（DAR）达8。（来源：Endpoints 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