The application heat of class 1 new drugs does not decrease top 5 enterprises, and 13 class 1 new drugs are approved

In 2019, CDE undertook 700 class 1 new drug applications In recent years, the application of class 1 new drugs mainly focuses on chemical drugs and biological products The field of tumor immunotherapy is still hot, and new drugs for liver diseases are emerging The enthusiasm for the application of class 1 new drugs in enterprises is high, and top 5 enterprises are changing 13 new class 1 drugs have been approved for marketing, involving multiple treatment fields In 2019, CDE undertook 700 class 1 new drug registration applications, involving 319 common names, an increase of 28% over 2018 In the atmosphere of encouraging drug innovation, in recent years, the enthusiasm of enterprises to apply for class 1 new drugs has continued to rise Application of class 1 new drugs in 2017-2019 (according to acceptance number) In terms of drug types, in recent years, the application of class 1 new drugs mainly focuses on chemical drugs and biological products In 2019, the proportion of new chemical drugs in Category 1 rose Changes in the proportion of class 1 new drugs in 2017-2019 (according to the acceptance number) In 2019, anti-tumor drugs are still the most popular field for class 1 new drugs, followed by immunosuppressants In addition, there are many enterprises in the field of liver disease drugs such as anti hepatitis B drugs and fatty liver drugs in 2019 Proportion of all treatment fields of class 1 new drugs undertaken by CDE in 2019 (by drug name) Tumor immunotherapy is a hot spot in the research and development of new anti-tumor drugs in recent years At present, the research and development of enterprises in this field mainly focuses on PD-1 / PD-L1 monoclonal antibody In addition, EGFR is also one of the hot targets in the field of anti-tumor At present, the development of EGFR has developed to the fourth generation It is worth noting that there are also a number of hepatitis B RNAi therapy drugs in 2019 Target distribution of class 1 new drugs in 2019 (by drug name) From the perspective of enterprise application, in 2019, enterprises have a higher enthusiasm for the application of new class 1 drugs There are 25 enterprises applying for more than 3 new class 1 drugs, compared with 17 in 2018 Among the top 5 enterprises, Hengrui still ranks first, followed by Xinda biology, and Zhengda Tianqing also ranks third with eight class 1 new drugs, with six in Zhongqi Pharmaceutical Group and six in cornerstone Pharmaceutical Group (Statistics of enterprise declaration by drug name) The following is the specific application of class 1 new drugs of top 5 enterprises in 2019 According to the statistics of medchina drug review database 2.0 on midnet, in 2019, 13 new drugs of category 1 were approved for marketing, with a total of 17 product regulations The approved new drugs of category 1 involve many treatment fields such as anti-tumor, diabetes, psoriasis, anti infection, vaccine, etc Class 1 new drugs approved for market in 2019