Inventory of biological products approved for marketing in 2015

Recently, CFDA released the approval of drug listing in 2015 According to statistics, in 2015, the State Food and Drug Administration approved 76 applications for listing registration of traditional Chinese medicine and natural drugs, 241 applications for listing registration of chemical drugs and 25 applications for listing registration of biological products Of the 25 biological products approved for marketing in 2015, 16 were biological products for treatment, 7 were biological products for prevention, and 2 were in vitro diagnostic reagents under drug management Among the approved biological product drug classifications for marketing in 2015, there are 8 import application types, among which there are 6 therapeutic biological products, 1 preventive biological product and 1 in vitro diagnostic reagent managed by drug Among the remaining 17 domestic new drug applications, except for one in vitro diagnostic reagent managed by drug, the registration types are as follows: 3 in class 1, 1 in class 5, 3 in class 7, and 9 in class 15 The types of biological product registration approved for listing in China in 2015 (attachment: biological product registration classification: Class 1, biological products not marketed at home and abroad; class 5, multi-component products with biological activity extracted from human and animal tissues or liquids, or prepared by fermentation; Class 7: biological products that have been listed and sold abroad but not yet in China; class 15: biological products that have national drug standards.) Moreover, the three varieties of class 1 are all biological products for prevention It includes one polio vaccine and two ev-71 vaccines In addition, 2 of the 3 varieties in Category 1 are from the Institute of medical biology, Chinese Academy of Medical Sciences Of the remaining four biological products for prevention, three are classified into 15 categories (including 1 DPT combined vaccine and 2 oral polio vaccine), and one is imported (influenza virus split vaccine) The remaining 1 class 5, 3 class 7 and 6 class 15 are domestic applied biological products for treatment In 2015, 16 registered types of therapeutic biological products approved for marketing were distributed in 6 categories and 11 categories Among them, the number of drugs used in blood and hematopoiesis system was the most, 6, followed by digestive system and metabolic drugs, anti-tumor and immunomodulator, 3 The classification of therapeutic biological products approved for marketing in 2015 specifically, two new drugs were approved, including anti-tumor drugs, plasma substitutes and infusion fluids, hemostatic drugs, bile, liver disease treatment drugs, anti-inflammatory drugs and anti rheumatic drugs Classification II of therapeutic biological products approved for marketing in 2015 Among these varieties, there are two exclusive varieties worthy of attention Jianzan, a rare disease drug company owned by Sanofi, uses the enzyme alpha for injection to treat a rare disease called "Pompeii disease" The data showed that the prevalence of the disease was 1 / 40000-1 / 300000 In addition, the recombinant human tissue plasminogen activator TNK mutant (rhtnk TPA) for injection of 7 new drugs from Guangzhou Mingkang Bioengineering Co., Ltd is also the exclusive one in China, which is mainly used for thrombolysis in patients with acute myocardial infarction within 6 hours Biological products approved for marketing in 2015 (Note: the number of the same product review report refers to the number of varieties of the same name that are still under review and to be reviewed, and the same manufacturer's different specifications are calculated together The quantity of the same product on the market includes the varieties approved in the above table.) Data source of this paper: CFDA, Sipu Online