Report card of domestic "class 1 new drugs" Application in the first half of 2018 - Biological Medicine

In recent years, the development of biopharmaceuticals has been stable and strong; whether it is the annual global sales list or the clinical situation of drugs under research, the development of biopharmaceuticals is gradually catching up - surpassing the status of small molecular drugs in clinical The first class of new drugs in biological medicine undoubtedly represents the latest R & D strength in the field of biological medicine in a country What is the situation of class 1 registration of biological drugs in China in the first half of 2018? Which enterprises have brought us what surprises? 1 Overall situation of domestic biological medicine application and registration in the first half of 2018 For biological products for prevention, in the first half of 2018, class 1 declared 6 varieties, class 2 declared 0 varieties, class 3 declared 2 varieties, class 4 declared 1 variety, class 5 declared 0 variety, class 6 declared 9 varieties, class 7 declared 0 variety, class 8 declared 0 variety, class 9 declared 1 variety, class 10 declared 0 variety, class 11 declared 1 variety, class 12 declared 1 variety, class 13 declared 0 variety There are 0 varieties declared in category 14 and 6 varieties declared in category 15 See the figure below for details Figure 1: Declaration of domestic biological products for prevention in the first half of 2018 (Note: supplementary application is not included) For biological products for treatment, in the first half of 2018, class 1 declared 62 varieties, class 2 declared 22 varieties, class 3 declared 3 varieties, class 4 declared 0 varieties, class 5 declared 0 varieties, class 6 declared 0 varieties, class 7 declared 21 varieties, class 8 declared 0 varieties, class 9 declared 0 varieties, class 10 declared 4 varieties, class 11 declared 1 variety, class 12 declared 0 varieties, class 13 declared 3 varieties There are 0 varieties declared in 14 categories and 0 varieties declared in 15 categories See the figure below for details Figure 2: Declaration of domestic biological products for treatment in the first half of 2018 (Note: supplementary application is not included) 2 Declaration of biological products for prevention category 1 In the first half of 2018, for the application of class 1 drugs for biological products for prevention, "human papillomavirus vaccine" is undoubtedly the biggest winner, and the domestic enterprise "Xiamen Wantai Canghai biology" has applied for the listing of this direction of products; the enterprises reported for clinical application are respectively "Beijing kangleywei", "Sinopharm Biotechnology Research Institute", "Beijing Shuanglu pharmaceutical industry", "Beibei" Jingnoning biology " In addition, for the prevention of category 1, except for the very popular "human papillomavirus vaccine", only the "Anhui zhifeilongkema" cow Mycobacterium vaccine (for people infected with tuberculosis) is declared as category 1 (for labor) Table 1: Declaration of class 1 biological products for prevention in the first half of 2018 (in chronological order) 3 The declaration of class 1 biological products for treatment is different from the "concentration" of biological products for prevention The use of biological products for treatment has always been relatively scattered In terms of product quantity, the number of class 1 new drugs in the first half of 2018 is far ahead of other categories In the first half of 2018, there were 58 clinical application varieties for class 1 therapeutic biological products, including 15 varieties that had entered special examination and approval, while there were 4 varieties that had applied for listing, namely, carrizumab for injection in "Suzhou shengdia", "sindelimab injection in" Xinda biology "," treprimab injection in "Suzhou Zhonghe biology", and "Jiangsu Wuzhong medicine" Group of recombinant human endostatin injection See the table below for details Table 2: Declaration of class 1 biological products for treatment in China in the first half of 2018 (in chronological order) 4 Summary & small sense For the prevention of class 1 biological products, through years of summing up, it is found that domestic Biopharmaceutical Enterprises are finally no longer around the old varieties, are trying to catch up with the world-class enterprises, and are trying to make better drugs In this regard, the author applauds For class 1 biological products for treatment, in terms of variety layout, it has gradually shifted from the general direction of anti-virus to the anti-tumor field which is still the hottest at present, especially some targets that we did not dare to touch Now we are trying hard to catch up with them as soon as possible Of course, it is better to go on the market synchronously Finally, it should be said that we should pay attention to the exploration of basic research (especially the national orientation) while catching up with the development frontier of pharmaceutical industry in the world It is not recommended to move with the trend After all, making medicine is a matter of patience.