|
Hutchmed China Ltd on Tuesday said it will start registration phase enrolments for two of its prospective treatments under study, HMPL-453 and savolitinib. The Hong Kong-based treatments of cancer and immunological diseases developer said it has agreed with the China National Medical Products Administration to initiate the registration of the ongoing phase 2 trial of HMPL-453 for intrahepatic cholangiocarcinoma patients with fibroblast growth factor receptors 2 fusion. This followed an initial consultation with the China NMPA. If positive, it said the data from the registration phase may be used to support a future new drug application filing. The first patient received their first dose in March 2023. Hutchmed said the study of HMPL-453 is a single-arm, multi-centre, open-label, phase 2 registration study to evaluate the efficacy, safety and pharmacokinetic of HMPL-453 in treating advanced IHCC patients with FGFR2 fusion. It has also agreed to initiate the registration phase of the ongoing phase 2 trial of savolitinib for gastric cancer patients with mesenchymal-epithelial transition amplification, following China NMPA consultation. If positive, the data from the registration phase may also be used to support a future NDA filing, while the first patient also received their first dose in March 2023. Hutchmed said the study of savolitinib is a single-arm, multi-centre, open-label, phase 2 registration study to evaluate the efficacy, safety and tolerability of savolitinib in treating gastric cancer and esophagogastric junction adenocarcinoma patients with MET amplification. The study is expected to enrol approximately 60 additional patients, it said. On Friday last week, Hutchmed said it had completed the rolling submission of a new drug application for its fruquintinib cancer drug to the US Food & Drug Administration, supported by 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. Hutchmed added that it intends to submit regulatory applications for the marketing of fruquintinib in Europe and Japan later in 2023. Shares in Hutchmed were up 6.9% to 218.00 pence each in London on Tuesday afternoon. Copyright 2023 Alliance News Ltd. All Rights Reserved.
|
