GNI is a clinical-stage bio-pharmaceutical company focusing on major diseases prevalent in Asia, especially China and Japan. Our drug development value chain is composed of discovery, development, manufacturing, and sales of drugs for the treatment of cancer and inflammatory diseases.
GNI is headquartered in Tokyo, Japan, with its major drug discovery and clinical research teams in Shanghai, China. The unique business model of GNI is to utilize the cost-effective and abundant clinical resources in China as our competitive strength to conduct proof-of-concept Phase I and II clinical trials in China, and then expand to Japan and other global markets.
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F647 is an oral, low molecular weight compound for the treatment of idiopathic pulmonary fibrosis (IPF) and radiation pneumonitis (RP). The IND had been approved by Chinese FDA in May 2005, and the Phase I clinical trail was completed in January 2006. Subsequently, Phase II human clinical trial was completed in August, 2008. In December, 2009, New Drug Application (NDA) for IPF was submitted to SFDA.
F351 is another oral compound to treat liver fibrosis and cirrhosis. GNI has filed PCT for F351 and the Chinese patent for F351 has been granted. After the IND filing for F351 was approved by the Chinese FDA in December 2007, F351 now is in Phase I clinical trial.
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Feb 23, 2010
Update On Progress Of F647 NDA Filing
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Jan 8,2010
PharmAsia News reported that China might be the third country in the world to have pirfenidone approved for Idiopathic Pulmoary Fibrosis. "In China, IPF is estimated to affect up to about 400,000 to 500,000 patients every year ......Our company is evaluating alternatives to secure a new plant to manufacture F647 in China ......," said Luo, CEO of GNI and Shanghai Genomics in the article." more |
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