Application for clinical research registration of a new drug of Hainan Haiyao for anti renal fibrosis was accepted

Haikou Pharmaceutical Factory Co., Ltd., a wholly-owned subsidiary of Hainan Haiyao Co., Ltd (hereinafter referred to as "Haikou pharmaceutical factory") and Central South University jointly applied for the clinical research registration of two specifications of "flufenidone" products, which has recently been officially accepted by the State Food and drug administration The product has been developed and applied in accordance with relevant laws and regulations and documents, and its clinical research registration application has been officially accepted, as follows: 1、 Drug name: flufenidone; acceptance No.: cxhl1301406 Qiong; applicant: Haikou Pharmaceutical Factory Co., Ltd and Central South University; application items: new drug application, chemical medicine category 1.1; dosage form: non preparation, API; packaging specification: 5kg / barrel 2 Drug name: flufenidone capsule; acceptance No.: cxhl1301407 Qiong; applicant: Haikou Pharmaceutical Factory Co., Ltd and Central South University; application items: new drug application, chemical medicine category 1.1; dosage form: preparation, Chinese Pharmacopoeia dosage form capsule; specification: 0.2g; package specification: 12 capsules / box Flufenidone is a new drug aiming at the treatment of organ fibrosis (organ fibrosis, which refers to the excessive deposition of extracellular matrix components in tissues and organs caused by various pathogenic factors, and is an important intermediate link and necessary stage for further development to organ sclerosis) Flufenidone products are mainly used to treat and prevent liver fibrosis and decompensated cirrhosis caused by chronic viral hepatitis, alcoholic liver disease, toxic liver disease, biliary cirrhosis, autoimmune hepatitis, schistosomiasis and chronic passive liver congestion; and to treat and prevent obstructive and reflux nephropathy, diabetic nephropathy, toxic nephropathy and focal disease Segmental glomerulopathy, diffuse sclerosing glomerulonephritis, renal arteriosclerosis, arteriosclerotic nephritis (chronic, interstitial) and other chronic kidney diseases (ckd1-4 stage) cause renal fibrosis Flufenidone is a new drug of chemical 1.1, and there are no products on the market at home and abroad