ETUARY®(艾思瑞® in Chinese)

CFDA Class 1.1 Pharmaceutical Drug

ETUARY®, originally designated at F647, is the commercial name for pirfenidone in China. Pirfenidone is a small molecule compound, with anti-fibrotic, anti-inflammatory, and anti-oxidation effects. Clinical studies have shown that pirfenidone significantly reduces decline in lung function and IPF (idiopathic pulmonary fibrosis) disease progression. Pre-clinical research in various animal models has also indicated that pirfenidone can inhibit the progress of liver fibrosis, pulmonary fibrosis, and kidney fibrosis in various animal models.

Clinical development

Shanghai Genomics, Inc. initiated the Phase I clinical trial for F647 in 2005 and in 2006 proceeded with the Phase II trial for idiopathic pulmonary fibrosis (IPF) therapy. A class 1.1 drug approval from the SFDA (State Food and Drug Administration, now the China Food and Drug Administration) was received in September 2011 as the only therapeutic treatment of IPF in China. Our joint venture subsidiary Beijing Continent Pharmaceutical Co., Ltd. obtained the manufacturing and sales permit in December 2013 and sales of ETUARY® (or艾思瑞® in Chinese) began in February 2014.

GNI is pursuing the following new indications for ETUARY®: treatment of radiation pneumonitis (RP), currently in pilot study for Phase III clinical trials; treatment of diabetic nephropathy (DN), pending IND approval; and treatment of connective tissue disease associated interstitial lung disease (CTD-ILD), pending IND approval.