Review of drugs accepted by CDE in April 2014 (I)

In April 2014, CDE received 770 drug applications, an increase of 25 over March Among them, 249 new drug applications, 188 copy applications and 60 import applications Figure in April 2014, the distribution of drug application types accepted by CDE The new drug applications registered as class 1 are all new drug clinical applications, with 23 applications involving 13 varieties, including 11 chemicals and 2 biological drugs Among these 1 chemicals, compound edaravone injection is 1.5, albumin paclitaxel for injection and doxycycline hydrochloride tablets are 1.6, and the registration classification of other drugs is 1.1 This month, there are two antineoplastic drugs declared, namely, beretinib from puruno in Beijing and ditinib from bebet in Guangzhou Beretinib is enteric coated capsule, while ditinib is injection There are three anti infective drugs, namely, ceftoren sodium phosphate for injection of Sichuan Kelun, disodium levononidazole phosphate for injection synthesized in Shaanxi, and asc08 tablets declared by Geli biology Asc08, also known as danoprevir, is an effective small molecule NS3 / 4 protease inhibitor for oral use It was initially developed by intermune in the United States Roche and Gilead have obtained license Currently, it is in phase II clinical research stage in the world and used for the treatment of hepatitis C virus infection There is one blood and hematopoiesis system drug, which is applied for BEPC Kemei, also known as roxadustat, is an effective second-generation selective HIF stabilizer for oral administration It was developed by fibrogen, and approved by anstera and AstraZeneca Now Kemei is in phase III clinical research stage in the world, which is used to treat chronic anemia The class 1 biological products declared this month are the recombinant human follicle stimulating hormone Fc fusion protein injection of Jilin kangningjierui and the recombinant human thymosin β 4 for injection of Beijing Northland Table name of enterprises with general name of drugs for clinical application of class 1 new drugs accepted by CDE in April 2014 Ceftoren sodium phosphate for injection 1.1 application of Kemei capsule (fg-4592 capsule) in blood and hematopoiesis system of Guangzhou bibete Pharmaceutical Technology Co., ltd.1 Beijing fabojin Pharmaceutical Technology Development Co., Ltd compound edaravone injection nervous system medication 1.5 Nanjing Youke Pharmaceutical Co., Ltd 1.1 recombinant human follicle stimulating hormone Fc fusion protein injection of Geli Biotechnology (Hangzhou) Co., Ltd Reproductive system medicine and sex hormone Haikou Pharmaceutical Factory Ltd., phnquin bromide nasal spray, sensory organ 1.1 Silver Valley Pharmaceutical Co., Ltd 1.1 albumin paclitaxel for injection of Shaanxi Synthetic Pharmaceutical Co., Ltd Antitumor drugs 1.6 doxycycline hydrochloride tablets of Zhejiang Haizheng Pharmaceutical Co., ltd.1.6 Kaifeng Pharmaceutical (Group) Co., Ltd recombinant human thymosin β 4 immunomodulator for injection 1 Beijing Northland Biotechnology Co., Ltd Beijing puruno Biotechnology Co., Ltd