Glumetinib, a MET targeted tyrosine kinase inhibitor (TKI) co-developed by CSPC Pharmaceutical Group Ltd (HKG: 1093) and Shanghai Haihe Pharmaceutical Co., Ltd, has been granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation (CDE) in China. The drug is indicated for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with negative driving genes and MET overexpression who have progressed after previous immunotherapy and chemotherapy.
Approval and Designation Milestones for Glumetinib
Glumetinib received approval for use in locally advanced or metastatic NSCLC with MET14 exon skipping in China in March this year. The drug also holds orphan drug designation (ODD) status in the US, awarded in 2022. CSPC entered into a licensing agreement with Haihe in December 2022, securing commercialization and promotion rights to the drug in Greater China, with Haihe serving as the Marketing Authorization Holder (MAH). Additionally, the drug was filed for marketing approval in Japan in September this year.- Flcube.com
