News Center

3/28

2020

Haihe Biopharma obtains the IND Approval from FDA for its Gumatinib c-Met Inhibitor

March 28, 2020 ,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 IND approval from the US Food and Drug Administration (FDA) for its innovative drug Gumatinib, a highly selective MET inhibitor developed by the company, to conduct a phase Ib/II clinical study to evaluate the safety, tolerability and pharmacokinetics of Gumatinib in patients with advanced solid tumors with MET mutations in US. The global principal investigator of the study was Professor Shun Lu from Thoracic Hospital Affiliated to Shanghai Jiaotong University.

Dr. Ruiping Dong, CEO of Haihe Biopharma, commented:
“Following the IND approval in Japan at the end of last year, Haihe has obtained the IND approval in another global main market. We are very pleased to achieve this staged result of global deployment. It will help us further promote our global development and commercialization process and strive to benefit cancer patients around the world as soon as possible.”
 
About Glumetinib

Glumetinib (code: SCC244) is a potent and highly selective small molecule MET kinase inhibitor with global proprietary intellectual property rights developed by Haihe Biopharma Co., Ltd and the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences. Preclinical studies have shown that Glumetinib potently and specifically targets the inhibition of MET kinase in vitro activity. Preliminary clinical studies have shown that Glumetinib has better human pharmacokinetic characteristics than small molecule MET kinase inhibitors with the same selectivity, including longer metabolic half-life, good permeability through the blood-brain barrier, etc. It showed preliminary efficacy as well as good safety and tolerability in patients with MET-positive advanced non-small cell lung cancer.

About Haihe Biopharma

Haihe Biopharma focuses on discovery, development and commercialization of innovative anti-tumor drugs. Guided by our mission, “Inclusive and open to diversity, innovation oriented to win together and benefit the mankind”, Haihe Biopharma insists on the way of independent innovation and pursues for global development of Chinese original innovative drugs in partnership with Shanghai Institute of Materia Medica, Chinese Academy of Science (SIMM). The company is led by an academician of the Chinese Academy of Engineering. The senior management team has extensive experiences in drug research and development in China and abroad. Haihe Biopharma has built a precision medical platform guided by biomarkers, and established a fully integrated pre-clinical evaluation technical platform and clinical study system for innovative drugs, with advanced technology and operation in consistence with international standards and norms, covering subunits from compound synthesis, CMC study, biomarker discovery and validation, medical strategy and clinical study, etc. The company has established a globally competitive innovative drug R&D system and robust product pipeline. There are 7 compounds in clinical and 3 compounds in preclinical studies, among which 7 compounds are discovered in-house.

Please visit the company website for more information:?http://www.iacubed.com

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