How about FDA approval of new drug registration in China in 2015?

16 of the 45 new drugs have relevant registration and evaluation in China, including 13 chemical applications and 3 therapeutic biological products applications FDA approved new drugs have always been the focus of attention of domestic pharmaceutical researchers It is an essential course for pharmaceutical companies to understand the specific information of these new drugs In 2015, FDA approved 45 new drugs, including 33 new molecular entities (NME) and 12 biological product licensing applications (BLA) According to the statistics of medchina drug review database of minenet, 16 of the 45 new drugs have relevant registration and review in the domestic drug review center, including 13 chemical drug applications and 3 therapeutic biological product applications 7 antineoplastic agents Among the 16 new drugs, there are 8 antineoplastic drugs and immunosuppressants, 7 antineoplastic drugs and 1 immunosuppressant; 2 systemic anti infective drugs, including 1 antiviral drug and 1 antifungal drug; 1 digestive system and metabolic drug, which are diabetes drugs; 4 cardiovascular system drugs, including 2 antithrombotic drugs, heart disease treatment drugs and actions One drug for renin-a system, one for other therapeutic products, and one for neuromuscular block reversal From the above analysis, we can see that the proportion of anti-tumor, cardiovascular and anti infection drugs is the largest three sectors, and these three areas are also the research and development hotspot in recent years The latest progress of domestic review 1 only 7 new drugs applied by the original research company according to the statistics of medchina drug review database of minenet, 7 of the above 16 new drugs only have the corresponding registration review of the original research company It is worth noting that tresiba (degu insulin injection) has been approved by the Japanese pharmaceutical medical device comprehensive agency (PMDA) on September 28, 2012, by the European Drug Administration (EMA) on January 21, 2013, and by the US FDA on September 25, 2015 At present, the drug is in the review stage in China, and the application type is listing application If all goes well, it is expected to be listed in China in 2017 The three new drugs in the approval clinical stage are alectinib capsule, daclatasvir dihydrochloride tablet and necitumumab, which still need a relatively long review time 2 it can be seen from Figure 2 that the 9 new drugs with domestic imitations are favored by many domestic drug developers, including 11, 18 and 14 domestic enterprises Among them, corlanor: ivabradine hydrochloride tablet is the most imitated enterprise, and Servier, the original research company, has been approved for listing in China on April 29, 2015 Novartis entresto (sacubitril / valsartan compound), which is one of the promising anti heart failure drugs in the industry, has also been imitated by many domestic enterprises, up to 14 The industry generally expects that the global sales of entresto will reach more than 4 billion US dollars in 2020 Pfizer's new antitumor drug, ibrance: palbociclib, pabacili capsule, was approved by the FDA on February 3, 2015 In 2015, the global sales reached as high as 723 million US dollars, and the sales peak is expected to reach more than 3 billion US dollars Due to the huge market demand, it is expected that entresto and ibrance will be sought after by domestic enterprises Through the analysis of the relevant review information of these nine new drugs, we can see the R & D strength of domestic enterprises Jiangsu Hengrui Pharmaceutical Co., Ltd., Jiangsu Shengdi Pharmaceutical Co., Ltd and Jiangsu aosaikang Pharmaceutical Co., Ltd are among the top three companies in terms of the number of imitations, which are 5, 5 and 4 respectively In addition, Beijing kanglisheng, Jiangsu Wanbang, Nanjing Zhengda Tianqing, Qilu pharmaceutical, Ruiyang pharmaceutical, Shijiazhuang Zhiheng pharmaceutical and Shiyao group all have two imitations, and the other 30 domestic enterprises all have one (not included in the analysis of the chart) Although this only refers to the imitation of FDA's new batch of drugs in 2015, it is only a small level, but it also indirectly shows the R & D strength of the top three companies