Daiichi Sankyo/AstraZeneca's (AZN.US) Enhertu Approved in China for HER2-Positive Gastric Cancer

Stock News01-23 14:50

On January 22, Daiichi Sankyo and AstraZeneca PLC (AZN.US) jointly announced that the injectable drug Enhertu has been officially approved by China's National Medical Products Administration. The approval is for the monotherapy treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received a trastuzumab-containing regimen. This indication marks the sixth approved use for Enhertu in China and is the second indication specifically related to HER2-positive gastric cancer. Enhertu is an antibody-drug conjugate targeting HER2, designed using Daiichi Sankyo's proprietary technology. It was developed by Daiichi Sankyo and is being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The approval for this new gastric cancer indication was based on results from the international, multicenter, two-arm randomized, open-label, Phase 3 DESTINY-Gastric04 clinical trial. In the DESTINY-Gastric04 study, Enhertu demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of overall survival (OS), as well as in the secondary endpoints of progression-free survival (PFS) and objective response rate (ORR). The safety profile was acceptable, generally manageable, and consistent with the known safety characteristics of the drug, with no new safety concerns identified. The study results were presented as a featured oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and were simultaneously published in The New England Journal of Medicine.

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The approval is for the monotherapy treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received a trastuzumab-containing regimen. This indication marks the sixth approved use for Enhertu in China and is the second indication specifically related to HER2-positive gastric cancer. Enhertu is an antibody-drug conjugate targeting HER2, designed using Daiichi Sankyo's proprietary technology. It was developed by Daiichi Sankyo and is being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The approval for this new gastric cancer indication was based on results from the international, multicenter, two-arm randomized, open-label, Phase 3 DESTINY-Gastric04 clinical trial. 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