Latest data of new drug approval in the first half of 2014

At the same time, the drug review center (CDE) of the State Food and drug administration undertook 4551 new drug registration applications in the first half of 2014 (based on the acceptance number), a record high Compared with the same period of the first half of last year, the drug acceptance volume of CDE was 3500, with a high growth rate compared with the same period of last year 22%, of which the increase was mainly due to chemical stretching, while the acceptance of traditional Chinese medicine and biological products slightly decreased compared with previous years In the first half of 2014, in the new approval documents for registration of chemical drugs (only the new approval documents are counted, excluding the change of approval documents, the same below), the proportion of approval documents of API in the new approval documents is 27.65%, and the proportion continues to rise The proportion of injection was 27.19% From the perspective of drug classification, the number of approval documents for digestive system and Metabolic Drugs ranked first, accounting for 17.51%, followed by systemic anti infective drugs, accounting for 17.05%, and the number of new approval documents for anti-tumor and immunomodulator drugs increased significantly, accounting for 11.52%, followed by the proportion of new approval documents for nervous system drugs and cardiovascular system drugs not more than 10% (see Figure 1) In the first half of 2014, there were 101 newly applied chemical 1.1 new drug registration applications involving 39 varieties Among them, two generic varieties of new drugs of category 1.1 have been applied for listing, and two generic varieties of new drugs of chemical medicine of category 1.1 have been approved for production Adefovir dipivoxil tablets have been approved for production by 14 enterprises, and the competition is becoming white hot Morpholinidazole is a new generation of nitroimidazole antibacterial drug independently developed by Haosen, Jiangsu Province According to the enterprise information, compared with the similar products on the market, it has the characteristics of strong antibacterial activity, good tolerance and high safety It is also the first class 1.1 new drug variety approved by Jiangsu Haosen so far However, there are many manufacturers competing for nitroimidazoles The data of sample hospitals show that the top five manufacturers account for 75.9% of the market, with high maturity In the first half of 2014, the number of new approvals for ambroxol hydrochloride for injection was the largest among the approvals for chemical preparations, with 4 manufacturers obtaining 4 approvals in total In the number of approval documents, there are many products of digestive system and metabolic drugs, including pantoprazole sodium for injection, Lansoprazole for injection, orlistat capsule, metformin glipizide tablet, lansoprazole enteric coated capsule, etc (see Table 1) In the digestive system and metabolic drugs, in the first half of 2014, the proportion of the new approvals of this kind of drugs, including antacids, peptic ulcer and flatulence drugs, was the highest, reaching 48.28%, followed by diabetes drugs, 17.24%, accounting for more than 60% (see Table 2) Among the new approval documents for digestive system and metabolic drugs, there are six generic varieties, among which pantoprazole has five approvals, covering two dosage forms, which are pantoprazole sodium for injection and pantoprazole sodium enteric coated tablets The approved diabetes varieties are metformin glipizide tablets, metformin glipizide capsules, Protamine Recombinant Human Insulin mixed injection (40 / 60), protamine zinc recombinant insulin mixed injection (25R) In the first half of 2014, there were only nine new approvals of traditional Chinese medicine registered, of which respiratory diseases accounted for the largest proportion, accounting for 44.44% Other products involved digestive system diseases, gynecology, skeletal muscle system diseases, pediatrics and facial features, with the same number of approvals Among the six kinds of new Chinese medicine approved by the state, Ranjiangduoji capsule of Sichuan Kangding Jinzhu pharmaceutical, zhulingjianpi capsule of Fuzhou Meifeng pharmaceutical of Jinling pharmaceutical and sanfengtongqiao dropping pill of Beijing huayangkuilong Pharmaceutical Co., Ltd In the first half of 2014, there were only four new approvals for biological products, most of which were vaccines and diagnostic kits The invention relates to the fields of digestive system and metabolic drugs, hormone preparations (excluding sex hormones) for the whole body and anti infective drugs for the whole body, most of which are vaccines and injections Specific drugs such as typhoid Vi polysaccharide vaccine of Beijing Zhifei green bamboo biopharmaceutical Co., Ltd have been approved, with the specification of 0.5ml/bottle, the dosage of 0.5ml/time for human use, and the content of typhoid Vi polysaccharide should not be less than 30 μ G It is applicable to children and adults over 2 years old The approval of the product further enriched the product line of Beijing Zhifei green bamboo biopharmaceutical The refined protein recombinant human insulin mixed injection (40 / 60) of Tonghua Dongbao Pharmaceutical Co., Ltd is a series of products of "Ganshulin", which has been successfully developed by Tonghua Dongbao since 1998 and has independent intellectual property rights in China (data source: CFDA)