Shanghai Haihe Pharmaceutical Co., Ltd’s Category 1 product, glumetinib, has obtained conditional market approval from the National Medical Products Administration (NMPA). The 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.
Development and Clinical Findings
Glumetinib, co-developed by the Chinese Academy of Sciences’ Shanghai Institute of Materia Medica (SIMM), has demonstrated preliminary efficacy in MET-positive advanced NSCLC. The drug exhibited a good pharmacokinetics safety and tolerability profile in a clinical study. The approval is based on the open, global, multi-center single-arm Phase II GLORY study, which showed that glumetinib was highly effective, safe, and controllable in locally advanced or metastatic NSCLC with METex14 hopping, either naïve or previously treated.
Advantages Over Existing Treatments
Glumetinib offers several advantages over similar products on the market. It has a higher steady-state valley concentration, ensuring continuous target inhibition. The drug also has a longer half-life, making it suitable for daily administration, and requires fewer drug interactions. Additionally, it has a lower safety risk when combined with other drugs. Glumetinib has also received an orphan drug designation from the US FDA for use in NSCLC with MET mutation.
Significance of the Approval
The NMPA approval of glumetinib marks a significant milestone for Haihe Pharmaceutical, providing a new treatment option for patients with MET-positive NSCLC. This development highlights the company’s commitment to advancing innovative therapies for lung cancer and improving patient outcomes.-Fineline Info & Tech
