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2019
August 27, 2019, Shanghai, China - HaiHe Biopharma, a biopharmaceutical company focusing on the discovery, development and commercialization of innovative anti-tumor drugs, announced that the first patient has been dosed in the Phase Ib clinical trial of the company's innovative drug, Glumetinib, for the treatment of MET-positive advanced non-small cell lung cancer. The principal investigator of this clinical trial in China is Professor Lu Shun from Shanghai Chest Hospital.
This is a multi-country, multi-center, open-label Phase Ib clinical trial to evaluate the efficacy and safety of Glumetinib in advanced NSCLC patients with c-MET mutations. It has been initiated in several sites nationwide, mainly enrolling the patients with locally advanced or metastatic non-small cell lung cancer diagnosed by histology or by cytology who had failed to respond to the previous standard treatment and were intolerant to or unsuitable for chemotherapy with at least one MET mutation (skipping , amplification, or overexpression) .
Lung cancer is the leading cause of cancer deaths in men and women, accounting for about one-fifth of all cancer deaths, more than the deaths caused by breast, prostate and colorectal cancer combined. Lung cancer can be divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), and 80%~85% of them are NSCLC. The abnormal activation of MET pathway can be divided into three cases: MET exon 14 skipping mutation, MET amplification and overexpression of MET protein. The incidence of MET exon 14 skipping mutation in NSCLC was 1-3%. The incidence of primary MET amplification in lung adenocarcinoma was about 2.4% (3 to 21%), and MET amplification resulted in 5-22% EGFR-TKI resistance. The incidence of MET protein overexpression was 22.2%-74.6%. Positive MET is associated with poor clinical prognosis, and no treatment targeting the mutation has been approved.
Glumetinib (SCC244) is an oral, potent and highly selective small molecule MET inhibitor. Glumetinib has excellent pharmacokinetic characteristics with long half-life and high steady-state trough concentration in human body, which is conducive to the continuous inhibition of the target. Glumetinib has shown robust efficacy and favorable safety profile in GLORY study in NSCLC patients with MET alterations. Haihe Biopharma owns the independent global intellectual property rights of Glumetinib.
Haihe Biopharma is an innovation-driven biotechnology company in China focusing on the discovery, development, production and commercialization of innovative anti-tumor drugs. Haihe brings life-saving therapies to cancer patients worldwide. It also has a research and management team with a global perspective, and is proactively mapping out the international development of innovative drugs. The Company currently has thirteen key drug candidates. As of today, Haihe Biopharma has received 21 IND or clinical trial approvals in four countries and regions.
