Hutchmed completes rolling FDA submission for colorectal cancer drug
HUTCHMED (China) Limited
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12:34 24/12/24
Pharmaceuticals developer Hutchmed China announced the completion of its rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for its oral inhibitor ‘fruquintinib’.
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The AIM-traded firm said the drug is intended for the treatment of refractory metastatic colorectal cancer (CRC), one of the most common and fatal cancers globally.
Fruquintinib was made available to patients in China in 2018, and had reportedly proved to be an important treatment option for CRC.
The NDA was supported by a global phase three multi-regional clinical trial conducted in the US, Europe, Japan, and Australia.
Hutchmed said the trial investigated the effectiveness of fruquintinib in combination with the best supportive care, compared to placebo and best supported care, in patients with refractory metastatic CRC.
Additionally, data from a study conducted in China also supported the NDA submission.
“In March, Hutchmed and Takeda Pharmaceutical Company closed an exclusive licence agreement to further the global development, commercialisation and manufacture of fruquintinib outside China,” the board explained in its statement.
“In China, fruquintinib is approved under the brand name ‘Elunate’, and is included in the China National Reimbursement Drug List.
“Hutchmed markets fruquintinib in China in partnership with Eli Lilly and Company.”
At 1511 BST, shares in Hutchmed China were up 1.38% at 220p.
Reporting by Josh White for Sharecast.com.