[heavyweight] data analysis of new antitumor drugs development in China

According to the prediction of global cancer report 2014 released by the World Health Organization (who), global cancer cases will show a rapid growth trend, from 14 million in 2012 to 19 million in 2025 and 24 million in 2035 Nearly half of the new cancer cases appear in Asia, most of which are in China China ranks first in new cancer cases, with 3.07 million new cancer patients and 2.2 million deaths, accounting for 21.9% and 26.8% of the global total respectively Who's data is slightly lower than China's own According to 2012 data released by the National Cancer Registration Center, about 3.5 million new cancer cases and 2.5 million people die each year in China The demand for antineoplastic drugs is increasing year by year Since 2007, anti-tumor drugs have been the leading category in the global pharmaceutical market, with a compound growth rate of 7.2% in 2008-2013 In China, the compound growth rate of this market is as high as 20.4%, far higher than the global growth level The number of applications for new drugs increased from 23 in 2010 to 44 in 2014; the number of applications for new drugs increased from 41 in 2010 to 233 in 2014, which has great potential in the anti-tumor drug market, causing great interest of domestic and foreign pharmaceutical companies At least 40% - 45% of the global new drug R & D investment is devoted to the research and development of anti-tumor drugs At present, several multinational pharmaceutical enterprises are competing to push the latest anti-tumor drugs to the Chinese market Although the research and development of anti-tumor drugs in China once lagged behind, many local enterprises began to focus on the research and development of anti-tumor drugs in the future under the influence of factors such as drug price adjustment, the start of medical reform and the expansion of serious illness medical insurance According to CDE review data, in recent five years, the number of new drug applications for anti-tumor drugs has increased year by year, from 75 in 2010 to 314 in 2014, and the number of varieties involved has increased from 30 to 79 From the perspective of registration type, the number of acceptance numbers of new anti-tumor drugs of category 1.1 increased from 23 in 2010 to 44 in 2014, involving varieties increased from 9 to 19 Among the 19 varieties, except that the p-toluenesulfonamide of Tianjin HongRi pharmaceutical industry belongs to the listing application, the remaining 18 are clinical applications The number of acceptance numbers of chemical 3.1 new drugs increased from 41 in 2010 to 233 in 2014, and the number of varieties involved increased from 16 to 48 It can be seen that the enthusiasm of drug companies in the research and development of new anti-tumor drugs is high The targets of VEGFR and EGFR inhibitors are the most serious ones in the line-up of TiNi group, but there are few popular targets of Raf / MEK, ALK, c-Met and JAK abroad In 2014, the acceptance numbers of afatinib, gefitinib, acitinib and erlotinib were more than 10 manufacturers applying for anti-tumor drug 1.1 in 2014, among which Guangdong dongyangguang Pharmaceutical Co., Ltd had the most acceptance numbers, up to 7, involving 2 varieties, and all of them were TiNi (tyrosine kinase inhibitor) varieties In the past decade, there are 1-2 new TiNi drugs on the market every year in the world, and they sell well TiNi drugs have been regarded as the future trend of clinical medicine by experts in the industry The excellent return has ignited the enthusiasm of many enterprises The R & D investment of major companies in TiNi drugs has reached 10 billion dollars In China, the application of TiNi innovative drugs is in full swing According to the application for new anti-tumor drugs in 2014, there are 23 TiNi varieties and 44 declaration manufacturers It is also common for one manufacturer to have multiple varieties and acceptance numbers, with 120 overall acceptance numbers Among the varieties, alfatinib has the most acceptance numbers, up to 17, and gefitinib, acitinib and erlotinib have more than 10 acceptance numbers, including 13 declaration manufacturers of gefitinib and 12 declaration manufacturers of erlotinib, with fierce competition From the perspective of registration classification, there are 10 varieties and 29 acceptance numbers for the application of class 1.1 TiNi new drugs, among which the clinical approval documents have been obtained from the New Drug Research Institute of Hangzhou East China Pharmaceutical Group; while the application of class 3.1 TiNi new drugs is the most, with 13 varieties and 86 acceptance numbers According to rough statistics, at present, there are at least 42 TiNi drugs independently developed in China, plus more than 20 imitated varieties The speed and heat of declaration of TiNi drugs are obviously higher than the industry expectation In 2012, the FDA approved six new TiNi drugs, reaching a peak, in 2013, only four were approved, and in 2014, only two were approved, which may be a signal that TiNi will gradually withdraw from the research and development field At present, more than 20 kinds of TiNi drugs have been listed abroad, and half of them have become domestic research and development direction It is worth noting that VEGFR and EGFR inhibitors (including multi-target) account for the majority of TiNi drugs, and the phenomenon of cluster research and development is quite serious; while the popular inhibitors such as Raf / MEK, ALK, c-Met and JAK are very rare in China According to the unwritten rules of the industry, there are more than five competitive manufacturers of the same variety In addition to the first imitated enterprises that may avoid huge risks, the price fight among other enterprises is bound to be fierce In the future, the research and development direction of anti-tumor drugs may need to be adjusted to avoid the risk of price reduction (BIOON Com)