GNI Announces Clearance Of Investigational New Drug (IND) By FDA For F351 Clinical Trials In The Treatment Of Liver Fibrosis

Published: Oct 10, 2017

TOKYO--(BUSINESS WIRE)--GNI Group Ltd., (TOKYO:2160) announced that GNI USA, Inc. (“GNI USA”), the wholly-owned subsidiary of GNI Group, had received U.S. FDA clearance on September 29 for the Investigational New Drug application (IND) for F351 (chemical name: Hydronidone) for U.S. clinical trials in the treatment of liver fibrosis.

F351 is an orally available, small molecule drug candidate with potential to treat liver fibrosis associated with chronic liver diseases. The patented new chemical entity (NCE) F351 drug has been shown to inhibit tumor growth factor (TGF)-ß1-induced collagen synthesis in hepatic stellate cell (HSC), a major fibrogenic cell type in the liver. It is also more potent than pirfenidone in reducing fibrosis in various animal models of liver fibrosis and kidney fibrosis. F351 is currently in a 240-subject Phase II clinical trial in China for the treatment of liver fibrosis associated with chronic hepatitis B infection.

GNI USA intends to initiate necessary procedures to start a Phase I open label study in the U.S. in early 2018 to determine safety, tolerability and pharmacokinetics of single and repeated doses of F351. Preliminary results are expected within 2018.

Dr. Ying Luo, GNI Group’s CEO, said: ”After successfully developed pirfenidone for iodiopathic lung fibrosis, we have been carefully screening for other candidates which may provide hope for liver fibrosis patients. Today’s IND approval is a major milestone for our company’s R&D strategy.”

GNI Group Ltd. does not expect the aforementioned submission will impact financial results for the year ending December 31, 2017.

About GNI Group Ltd.

GNI Group Ltd. is listed on the Tokyo Stock Exchange Mothers Market, Code 2160, with headquarters in Tokyo and subsidiaries in Hong Kong, Shanghai, Beijing and the United States. In the United States, GNI Group has, through its wholly-owned subsidiary GNI USA, Inc., a consolidated subsidiary, Berkeley Advanced Biomaterials LLC. which is a developer and manufacturer of high-quality, cost-effective bone grafts substitutes and headquartered in Berkeley, California. For further information about GNI Group Ltd., please visit www.gnipharma.com., and about Berkeley Advanced Biomaterials, Inc., please visit http://www.hydroxyapatite.com/.

This press release contains "forward-looking" statements, including statements related to the Group's plans to pursue development of product candidates and the timing thereof. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "continue," "expected to", "will" and similar expressions are intended to identify these forward-looking statements. There are a number of important factors that could cause the Group's results to differ materially from those indicated by these forward-looking statements, including risks associated with the timing and success of clinical trials and the commercialization of product candidates. The Group does not undertake any obligation to update forward-looking statements.

GNI Group Ltd.
Thomas Eastling, +81 (03) 6214-3600
infojapan@gnipharma.com

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