23rd Oct 2026 13:16
(Alliance News) - Daiichi Sankyo Co Ltd on Friday said its cancer treatment Enhertu has received regulatory approval in China, while the company announced "promising" trial results.
The Tokyo-based pharmaceutical company said Enhertu, developed with Cambridge, England-based AstraZeneca PLC, has been approved in China for adults with unresectable or metastatic solid tumours that test strongly positive for HER2. The approval covers patients who have received prior treatment or have no satisfactory alternative options.
The treatment approval by China's National Medical Products Administration follows results from four phase 2 trials which demonstrated clinically meaningful responses across a broad range of tumours, the company said.
Enhertu is an antibody-drug conjugate that targets HER2, a protein that can promote cancer growth when present at high levels in tumour cells.
Daiichi Sankyo China President Michio Hayashi said: "This approval of Enhertu reflects the continued evolution of cancer care toward treatment regimens focused on the underlying biology of the disease rather than where a tumor originates in the body.
"As the first tumor agnostic HER2 directed medicine approved in China, Enhertu has
the potential to expand treatment for eligible patients across a broad range of HER2 positive metastatic cancers."
Separately, Daiichi Sankyo said new data from six trials reinforced the potential of Enhertu and Datroway in breast and lung cancer.
The company said analyses from two trials of raludotatug deruxtecan, an experimental drug that targets CDH6 on cancer cells, highlighted its potential as a treatment for ovarian cancer.
Daiichi Sankyo Global head of research & development John Tsai said: "The promising data for raludotatug deruxtecan in ovarian cancer and the robust scientific innovation demonstrated across our pipeline reflects our progress in advancing research for patients across multiple types of cancer."
New clinical research is set to be presented across in multiple cancers at the 2026 European Society for Medical Oncology Congress, Daiichi Sankyo confirmed.
Daiichi Sankyo shares closed down 0.7% to JPY2,817.50 per share on Friday in Tokyo.
AstraZeneca shares meanwhile were 1.5% lower at 12,782.00 pence each on Friday afternoon in London.
By Niall Holden, Alliance News reporter
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