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Daiichi Sankyo Co Ltd and AstraZeneca PLC on Thursday said Chinese regulators have approved their jointly developed drug Enhertu to treat gastric cancer. Enhertu is now cleared as a second-line treatment for adults in China with the HER2 metastatic variant of the disease, who already have completed one round of trastuzumab-based therapy. This marks Enhertu’s sixth approved indication in the country, Daiichi noted. Back in 2020, the China Center for Drug Evaluation designated Enhertu a ‘breakthrough therapy’ for the second-line gastric cancer indication, based on early trial data. The drug also had priority review status, which fast-tracked the approval process. The decision was based on phase-three trial results tying Enhertu to ‘statistically significant and clinically meaningful improvement in overall survival’, when compared with a ramucirumab and paclitaxel combination, Daiichi said. The Tokyo-based pharmaceutical firm claims discovery of Enhertu, an antibody drug-conjugate, which it is commercialising with Cambridge, England-based AstraZeneca. Lin Shen, director of Gastrointestinal Oncology at Peking University Cancer Hospital and leader of the phase-three trial, called the approval decision ‘an important milestone for the clinical community in China, addressing a critical gap’. ‘This development is driving a paradigm shift from chemotherapy towards precision therapy in the second-line setting for patients with HER2 positive gastric cancer. At the same time, it provides clinicians with a powerful new option capable of significantly extending patient survival,’ Shen continued. Michio Hayashi, Daiichi’s China president, said: ‘This sixth approval for Enhertu in China in less than three years fully demonstrates the potential of this innovative medicine to make significant contributions in clinical practice.’ Dave Fredrickson, AstraZeneca’s vice president of Oncology Hematology, added: ‘Enhertu is already established in China in the third-line or later treatment setting for patients with HER2 positive metastatic gastric cancer and this approval brings this important medicine to an earlier line of therapy.’ Daiichi shares closed 1.3% lower at JP¥3,139.00 on Thursday in Tokyo. AstraZeneca edged up 1.1% to 13,482.00 pence per share on Thursday morning in London. Copyright 2026 Alliance News Ltd. All Rights Reserved.
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