Shanghai Haihe Pharmaceutical Co., Ltd, a Chinese pharmaceutical company, has announced that it has received marketing approval in Japan for its MET targeted tyrosine kinase inhibitor (TKI), glumetinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET 14 exon mutation.
The approval is supported by the efficacy and safety data from the pivotal Phase II GLORY study, a multi-country, multi-center, open, single-arm trial designed to evaluate the efficacy and safety of glumetinib in patients with locally advanced or metastatic NSCLC with a MET 14 exon mutation. Glumetinib initially received marketing approval in China in March 2023 for this indication. The drug was discovered by the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and was included in the National Reimbursement Drug List in China at the end of 2023.- Flcube.com
