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(Alliance News) - Hutchmed (China) Ltd on Friday said it has completed the rolling submission of a new drug application for its fruquintinib cancer drug to the US Food & Drug Administration.
The Hong Kong-based treatments of cancer and immunological diseases said the new drug application is supported by its global phase 3 multi-regional clinical trial, which was conducted in the US, Europe, Japan and Australia.
The FDA submission is for fruquintinib to be used to treat refractory metastatic colorectal cancer. Refractory cancer is when the disease does not respond to treatment. Metastatic cancer is when it spreads to distant parts of the body.
Chief Medical Officer Michael Shi said: "This FDA submission is a significant milestone for patients in the US with metastatic CRC, one of the most common and deadly cancers in the US and worldwide. Fruquintinib is an important treatment option for patients with metastatic CRC in China, where it has been available to patients since 2018."
The firm added that it intends to submit regulatory applications for the marketing of fruquintinib in Europe and Japan later in 2023.
Hutchmed shares rose 2.3% to 221.89 pence each in London on Friday afternoon.
By Harvey Dorset, Alliance News reporter
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