8th Aug 2022 09:17
(Alliance News) - Hutchmed Ltd on Monday announced phase 3 of its fruquintinib FRESCO-2 study met its primary endpoint.
As a result, the company intends to submit marketing authorisation applications as soon as possible, it said.
Shares in Hutchmed were up 8.4% at 238.50 pence in London on Monday morning.
The Hong Kong-based biopharmaceutical company conducted phase 3 of its FRESCO-2 trial in the US, Europe, Japan and Australia to investigate the efficacy of fruquintinib, a chemical compound, in patients with advanced, refractory metastatic colorectal cancer. Refractory cancer is when the disease has not responded to treatment, while metastatic is when the disease spreads to other parts of the body.
The trail met the primary endpoint of overall survival in patients, and the safety of fruquintinib was found to be consistent with previous studies. Hutchmed will present full results at an upcoming medical meeting.
Looking ahead, Hutchmed plans for regulatory submissions regarding the trial's design and conduct, with marketing and authorisation applications in the US, Europe and Japan underway.
Hutchmed retains all commercial rights to fruquintinib outside of China and is partnered with Eli Lilly & company in China, where the chemical compound is marketed under the brand name Elunate.
"We are very happy to see the positive outcomes of the FRESCO-2 study which offers a potential new treatment for patients with advanced metastatic colorectal cancer, where the unmet need is very high and patients have limited treatment options... Results from the global FRESCO-2 study supplement findings from the original FRESCO study that led to the marketing approval and commercialization of fruquintinib in China," said Marek Kania, executive vice president, managing director and chief medical officer of Hutchmed International.
By Dominique Pretorius; [email protected]
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