日本語
.jpg)
2019
December 11, 2019 ,Shanghai, China - HaiHe Biopharma, a company focusing on the discovery, development and commercialization of innovative anti-tumor drugs, announced that the company has recently obtained the Acknowledgement of Clinical Trial Notification (CTN) from the Pharmaceuticals and Medical Devices Agency of Japan (PMDA) for its innovative drug Glumetinib, a highly selective MET inhibitor developed by the company, to conduct a phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of Glumetinib in patients with advanced solid tumors in Japan. The principal investigator of the study was Professor Kazuhiko Nakagawa from the Kinki University Hospital, Japan.
“Glumetinib is the second project for which HaiHe has obtained the IND implied license outside China this year. We have taken a solid step towards international development while actively promoting our innovative drug pipeline. Based on HaiHe team’s years of research and accumulation in the field of tumor, we will bring more cutting-edge new drugs to the international market and further expand the global presence for HaiHe creativity,” said Academician Ding Jian, Chairman of HaiHe Biopharma.
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.
