Shanghai Haihe Pharmaceutical Co., Ltd’s Category 1 product, glumetinib, has received conditional market approval from the National Medical Products Administration (NMPA). This small-molecule MET inhibitor is now approved for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET14 exon hopping, marking a significant advancement in the therapeutic options available for this patient population.
Clinical Efficacy and Safety Profile
Glumetinib, co-developed by Haihe Pharma and the Chinese Academy of Sciences’ Shanghai Institute of Materia Medica (SIMM), has demonstrated preliminary efficacy in treating MET-positive advanced NSCLC. Clinical studies have shown that the drug has a favorable pharmacokinetics safety and tolerability profile. The approval is based on the results of the open, global, multi-center single-arm Phase II GLORY study, which indicated that glumetinib is highly effective, safe, and controllable in locally advanced or metastatic NSCLC with METex14 hopping, whether in treatment-naïve or previously treated patients.
Advantages Over Existing Therapies
Glumetinib stands out among similar products currently on the market due to its higher steady-state valley concentration, which ensures continuous target inhibition. It also has a longer half-life, making it suitable for daily administration. Additionally, glumetinib requires fewer drug interactions and poses a lower safety risk when combined with other medications. Furthermore, the drug has been designated as an orphan drug by the US FDA for use in NSCLC with MET mutation, highlighting its potential in addressing unmet medical needs.-Fineline Info & Tech
