智通财经APP获悉，9月28日，国家药监局(NMPA)官网显示，默沙东的帕博利珠单抗注射液(皮下注射，即MK-3475A)在华获批上市。该制剂可以每3周注射1次(1分钟内完成给药)，也可以每6周注射1次(2分钟内完成给药)，比需要静脉输注30分钟完成给药的静脉注射制剂更节省时间且便利，并且还可以选择大腿或腹部注射，避开肚脐周围5厘米的区域。

2024年11月，默沙东宣布关键性III期MK-3475A-D77研究取得了积极结果。该研究是一项随机、开放标签临床试验(n=378)，评估了帕博利珠单抗皮下注射剂MK-3475A与帕博利珠单抗静脉注射剂Keytruda相比，联合化疗用于转移性非小细胞肺癌(NSCLC)成人患者一线治疗的药代动力学(PK)、疗效和安全性。研究的双重主要终点分别是：首个给药周期内帕博利珠单抗的药时曲线下面积(AUC)以及稳态时测得的帕博利珠单抗给药最低浓度(Ctrough)。次要终点包括其他PK参数、疗效性指标(包括客观缓解率、缓解持续时间、无进展生存期和总生存期)和安全性终点。结果显示，该研究达到了其双重主要终点。

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