Jing Ji Guan Cha Wang·2026-01-24 10:27Core Viewpoint - Daiichi Sankyo announced that Enhertu (injectable trastuzumab deruxtecan) has officially received approval from the National Medical Products Administration (NMPA) in China for second-line treatment of HER2-positive adult patients with gastric or gastroesophageal junction adenocarcinoma [1] Group 1: Approval and Indications - The new indication marks the sixth approval for trastuzumab deruxtecan in China and the second indication related to HER2-positive gastric cancer [1] - This approval signifies that trastuzumab deruxtecan is the first and only approved antibody-drug conjugate (ADC) for second-line treatment in this patient population in China [1] Group 2: Development and Clinical Trials - Trastuzumab deruxtecan is designed to target HER2 and is a DXd antibody-drug conjugate developed and commercialized by Daiichi Sankyo in collaboration with AstraZeneca [1] - The approval for the new gastric cancer indication is based on results from the international multicenter, randomized, open-label Phase III study DESTINY-Gastric04, which demonstrated statistically significant and clinically meaningful improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) [1]