Have you kept up with the trend of class 1 new drug application?

1 The phase I clinical trial of small molecular compounds applied by Shenzhen junshengtai Biotechnology Co., Ltd for the treatment of chronic liver disease has been filed by the Australian pharmaceutical regulatory department, with the filing number 2017-02-131 2 Shanghai Jingfeng Pharmaceutical Co., Ltd plans to purchase jzb27 project drug clinical trial approval documents and phase I clinical trial related materials from Shanghai Jingze Biotechnology Co., Ltd., a joint-stock company, for RMB 64 million 3 129 drugs (calculated according to the acceptance number, the same below) entered the CDE evaluation center this time (March 27, 2017 to April 7, 2017), including 4 traditional Chinese medicines, 106 chemical drugs, 15 biological products and 4 other varieties This time, 13 new drugs (by varieties, the same below) of category 1 entered the evaluation center, including 2 imported new drugs of category 1 in chemistry, 8 new drugs of category 1 in chemistry and 3 new drugs of category 1 in biological products Zl-2302 and its tablets (acceptance No.: cxhl1700045-47) jointly declared by Shanghai xuantai Haimen Pharmaceutical Co., Ltd and zaiding Pharmaceutical (Shanghai) Co., Ltd are used for the treatment of non-small cell lung cancer; kangdariwei sodium and its tablets (acceptance No.: cxhl1700042-44) submitted by Guangdong dongyangguang Pharmaceutical Co., Ltd are potential drugs for the treatment of hepatitis C; Shanghai representative of Eli Lilly Asia Co., Ltd Ly2835219 (acceptance No.: jxhl1700063-64) declared by the table, with the drug name of abemaciclib mesylate, is used for the treatment of metastatic breast cancer and non-small cell lung cancer, and is currently in the clinical phase III 2 Recently, Tianfang Pharmaceutical Co., Ltd and Henan Zhongshuai pharmaceutical science and Technology Co., Ltd jointly applied for the class 3.1 new drug fenofibrate choline and its sustained-release capsule (acceptance No.: cxhl1502245, cxhl1502248-49), and obtained the clinical trial approval The indications of fenofibrate choline are blood lipid regulating drugs, which can reduce TG, LDL-C, total cholesterol, TG and apolipoprotein B in patients with severe hypertriglyceridemia, and increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia Fenofibrate choline sustained-release capsule is a kind of lipid regulating drug of chlorobetadic acid derivative, which was listed in FDA in December 2008 by Abbott ibuprofen The product on the market is trilipix, and has been listed in many countries At present, the product is not listed in China According to the data, the sales volume of ibovefenofibrate choline sustained release capsule in 2015 is about US $163.1 million 4 Recently, HISCO Pharmaceutical Group Co., Ltd and its subsidiaries Sichuan HISCO Pharmaceutical Co., Ltd and Liaoning HISCO Pharmaceutical Co., Ltd received the CFDA's approval for the clinical trial of indarterol maleate (acceptance No.: cxhl1600014), doxyramine succinate and its vitamin B6 enteric coated tablets (acceptance No.: cxhl1600047-48) Indarterol is a long-acting β 2-adrenergic receptor agonist, and its indications are maintenance therapy for adult COPD patients Prior to Hisilicon subject, the development of nindartrogram ammonium bromide inhalation powder mist compound is in progress, and the clinical trial application has been submitted according to the original chemical category 3.2 There is no import of indadroglom bromide inhalation powder and mist compound, and the global sales in 2016 was about US $363 million Doxyramine succinate vitamin B6 enteric coated tablet is a compound preparation composed of doxyramine succinate and vitamin B6 Each tablet contains 10mg doxyramine succinate and 10mg vitamin B6 The indication is used to treat nausea and vomiting during pregnancy which has poor response to conservative treatment Doxyramine succinate vitamin B6 enteric coated tablet was developed by duchesnay company of Canada and approved by FDA of the United States in April 2013 Its trade name is diclegis It is the only drug approved by FDA to treat vomiting during pregnancy At present, it has not been imported or produced in China Doxyramine succinate vitamin B6 enteric coated tablets developed by HISCO are used for the treatment of nausea and vomiting during pregnancy with poor response to conservative treatment Its active ingredients are the same as the original product 5 The 23 valent pneumococcal polysaccharide vaccine (acceptance No.: cxss1400005) independently researched and developed by Yunnan Watson Biotechnology Co., Ltd and declared by the wholly-owned subsidiary Yuxi Watson Biotechnology Co., Ltd has been approved for listing by CFDA with approval No.: gyzz s20170003 Each dose of 23 valent pneumococcal polysaccharide vaccine contains 25 mg of purified capsular polysaccharide of 23 serotypes This vaccine is used for the vaccination of people with increased risk of pneumococcal infection over 2 years old, and for the prevention of pneumococcal diseases caused by 23 pneumococcal serotypes contained in this vaccine At present, only 23 valent pneumococcal polysaccharide vaccines from MSD, Pasteur and Chengdu Institute of biological products are available for sale in the world Watson biology is the fourth company in the world and the second one in China that has obtained the listing license In addition, Watson biology's 23 valent pneumococcal polysaccharide vaccine adopts the preservative free preparation process, which is the first 23 valent pneumococcal polysaccharide vaccine without preservatives in the world 。 According to the data query, the global sales volume in 2016 was about $750 million, and the domestic market was about $150-150 million Original statement: This article is the original manuscript of yaozhi.com, welcome to reprint, reprint please indicate the source, thank you!