|
Hutchmed China Ltd on Thursday announced regulatory approval for savolitinib, brand name ’ORPATHYS’, for a form of gastric cancer with ‘a very poor prognosis’. The Hong Kong-based biopharmaceutical company said the China National Medical Products Administration, or NMPA, has granted conditional approval to its new drug application for savolitinib, as a treatment for locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments. Shares in Hutchmed jumped 11% to 178.50 pence in London early on Thursday afternoon. Hutchmed said gastric cancer is ‘one of the most common cancers and leading causes of cancer death in China,’ and that MET-driven gastric cancer ‘has a very poor prognosis.’ The company is jointly developing savolitinib with AstraZeneca PLC, which is also commercialising the drug. The approval, it said, was supported by data from the ‘pivotal’ phase 2 registration study of savolitinib, which met its primary endpoint of objective response rate. The ORR was 32.3% as of the October 8 cut-off, which exceeded the pre-specified efficacy threshold. The secondary endpoints included a disease control rate of 63.1% and median progression-free survival of 4.0 months. ‘The approval of ORPATHYS for MET-amplified advanced gastric cancer is an important achievement that underscores Hutchmed’s enduring commitment to bringing in-house discovered innovations to patients,’ comments Acting Chief Executive Officer & Chief Financial Officer Johnny Cheng. ‘This marks the third approved indication for ORPATHYS in China and further validates our proprietary R&D platform’s ability to address deep unmet medical needs. ‘Together with our partner AstraZeneca, we are proud to expand the clinical application of this highly selective MET inhibitor and look forward to accelerating its commercial availability to transform gastric cancer treatment landscapes in China.’ Copyright 2026 Alliance News Ltd. All Rights Reserved.
|
