"Eight year Anti Japanese War" of new drug application (data analysis from 2008 to 2015)

Source: Xinkangjie, January 18, 2016 | analysis of the top ten products in domestic declaration from 2008 to 2015, the top ten products in domestic declaration from 2008 to 2015 can be divided into three categories: 1) follow-up strategy: copy the original research products with large domestic sales through Xianda data v3.2 It is found that atorvastatin calcium tablets are the most frequently declared drugs by domestic manufacturers since 2008 Although there are many acceptance numbers for domestic declaration, there are only two approvals from real domestic manufacturers (excluding sub packaging), namely Beijing Jialin Pharmaceutical Co., Ltd and Zhejiang xindonggang Pharmaceutical Co., Ltd., which may be related to the patent of atorvastatin calcium tablets In addition, esomeprazole sodium for injection, which is also limited by patents but with a large number of applications, ranks third in the list At present, no generic drug has been approved 2) Simple repetition: the policy of antibiotics restricted three years before it affected the R & D Application of cefdixone sodium for injection, cefotiam hydrochloride for injection and Cefmetazole sodium for injection ranked second, sixth and ninth respectively After the promulgation of the regulations on the administration of antibiotics in 2011 and until 2013, almost every year, there are products of antibiotics injection in the top ten It can be seen that there is a certain time gap from policy supervision to market reaction to the change of R & D direction 3) Rush to copy: the products that have been listed in foreign countries but not in domestic market are the products that have been listed in foreign countries but not in domestic market, such products generally choose the generic product that has been listed in domestic market to change the dosage form After sorting out the annual cumulative declaration volume from 2008 to 2015, the author found that except for September 2015, the annual cumulative declaration volume of category 3.1 was almost lower than that of category 6 In terms of the overall trend, the number of category 3.1 and category 6 declaration is increasing, among which the annual cumulative declaration increment of category 6 in 2011 is higher than that of category 3.1, while that of category 3.1 and category 6 in 2012 and 2013 is basically the same, and that of category 3.1 in 2014 and 2015 is higher than that of category 6 This means that in recent two years, there have been more and more domestic anti-counterfeiting applications and "anti counterfeiting" has become a hot choice for R & D project application Annual cumulative declaration volume from 2008 to 2015: category 3.1 vs category 6 | top 10 domestic products declared in 2008 to 2015 from 2008 to 2009 In, antibiotic injections and tablets, such as cefdixone sodium for injection, Azithromycin Dispersible Tablets, Cefmetazole sodium for injection and levofloxacin hydrochloride capsules, cardiovascular oral drugs, such as simvastatin tablets and amlodipine besylate tablets, and infusion solutions, such as glucose injection and sodium chloride injection solution, were all hot spots for declaration Since 2014, there are no products in the top ten for antibiotic injection and tablet, and no products in the top ten for infusion after 2010 Cardiovascular products are always on the list This reflects from the side that when the use of drugs is developing towards standardization, the product declaration will also move towards the direction of therapeutic drugs Products driven by policies and profits can enjoy a while, but may not be good for a long time In terms of imitating the products that have been on the market in China, specialized drugs have always been the hot spot of application: in 2011, the most hot spot of application was clopidogrel bisulfate tablets, and in 2014, esomeprazole sodium for injection The reported treatment areas are also diversified: cancer drugs such as capecitabine and dasatinib, male erectile dysfunction drugs such as tadalafil, non steroidal anti-inflammatory and analgesic drugs such as celecoxib capsule are all emerging hot areas of research and application In addition to 2014, from 2010 to 2015, there were domestic unlisted and foreign listed rush to copy products ranked first in the number of application acceptance numbers In 2010, the largest number of non bustard tablets was accepted The type of application is 3.1 At present, there are 6 production approvals, all of which were approved in 2013, corresponding to 3 manufacturers Ibuprofen injection ranked first in 2011 and 2012 In 2013, azilsartan tablets ranked first in the treatment of hypertension In 2015, wotixitin hydrobromide was the first MDD drug for adults with severe depression Top 10 applicants from 2008 to 2010, top 10 applicants from 2011 to 2013, top 10 applicants from 2014 to 2015 In 2015, the number of application acceptance numbers of domestic unlisted and foreign listed imitation products was basically the same as that of domestic listed imitation products In 2015, the registration law cancelled the new drug certificate of domestic unlisted and foreign imitated products, and the national requirements for imitated drugs were raised to the same level as the original research drugs, the clinical examination was strict, the project implementation was more difficult, and the project establishment would be more and more cautious.