Panoramic perspective of application for registration of biological drugs in 2017, injection accounted for 90.42%

Source: IGU 2018-03-05 I The overall registration and application trend of biological products 2017 is a good year for the development of biomedicine According to the data of pharmaceutical intelligence, the overall trend of the number of biological products (including treatment and prevention) undertaken in the past 10 years has increased, reaching the maximum in 2017, 616 (calculated by acceptance number, the same below) Although the proportion of biological products in all drugs is less than that of chemical drugs, its trend has been greatly improved in the past three years, which also reflects the current wave of development of biological products Figure 1 Overall registration and application of biological products in 2008-2017 2 Application types of biological products in 2017 are shown in the figure below, with the maximum number of supplementary applications being 271 In addition, there are 193 new drug applications and 111 import applications, accounting for 31.33% and 18.02% respectively It can be seen that in the application for registration of biological products, new drugs still catch up with and surpass imports, 30 more than imports in 2016 and 82 more in 2017, with a year-on-year growth of 63.41% In the field of biological products, we are stepping up our steps with a promising future Figure 2 In 2017, 193 new drug registrations of biological product registration application types were classified into 193 new drugs We can see that 76 new drugs of category 1 were applied for the most, and 13 new drugs and 2 new drugs were applied for the most At present, 30 new drugs have been approved for clinical application, and 2 new drugs have been approved for production They are recombinant Ebola virus vaccine for class 1 heavy and excellent prevention biological products of kangxinuo biological Co., Ltd and polio inactivated vaccine (Vero cell) for class 6 prevention biological products of Beijing Beisheng research biological products Co., Ltd Figure 3 In 2017, the new drug registration classification of biological products III The current status of CDE processing is shown in Figure 4 There are 374 biological products under review and approval, 191 of which have been certified and approved Almost two fifths of the business has been completed It can be seen that the efficiency of CDE is getting higher and higher under the promotion of the new policy Figure 4 In 2017, the application status of biological products IV in 2017, we can see that injection and powder injection accounted for a large proportion, 419 and 138 respectively, accounting for 68.02% and 22.40% These two dosage forms belong to injection products, so injection is the key direction in biological products In 2017, CDE issued a notice on Soliciting Opinions on technical requirements for conformity evaluation of listed chemical generic drugs (injections) The issuance of this notice seems to mean that there will be new changes in the injection industry Chemical injection is facing reshuffle Biological products are just emerging at this moment 2018 will not be the best time for its development Figure 5 Application forms of biological products in 2017 5 The application enterprises can be seen from the following ranking of application quantity Among the 15 companies with the largest number, many are joint ventures between domestic enterprises and foreign companies, or foreign legal persons or wholly-owned group companies The top 15 domestic companies are Nanyue biopharmaceutical, Beijing Tiantan biology and Shanghai Institute of biology, which have applied for 11, 9 and 9 drugs respectively Although the number of applications accepted by these 15 enterprises is large, most of them are imported or supplementary applications, with fewer new drugs From the ranking with new drug companies, it can be seen that the national research capacity of biological products is clear at a glance, and Shanghai Pharmaceutical Research Institute is the winner of the application of biological products in 2017 (Note: the application for registration here only looks at a single company, not the head office.) Figure 6 Ranking of biological products application companies in 2017 Shanghai roche-4 varieties In 2017, Shanghai Roche registered and applied for 4 varieties, including 4 applications for rituximab injection, 4 applications for trastuzumab injection, 4 applications for pegylated interferon α - 2A injection, and 15 applications for recombinant human erythropoietin β injection (CHO cells) (10 imported re registration, 5 supplementary applications) Wyeth Pharma - three kinds of Wyeth Pharma are applied for registration of three kinds, namely, two supplementary applications for enacept for injection, 12 recombinant human coagulation factor IX for injection (8 supplementary applications, 4 import re registration), and 8 recombinant human coagulation factor VIII for injection (4 supplementary applications, 4 import re registration) Denmark novo Nord - 8 varieties Denmark Novo Nordisk registered and applied for 8 varieties, including 2 supplementary applications of degu insulin injection, 1 supplementary application of lilalutide injection, 1 supplementary application of aspartic insulin injection, 4 supplementary applications of aspartic insulin 30 injection, 4 supplementary applications of aspartic insulin 50 injection, 2 supplementary applications of recombinant human coagulation factor ⅶ a for injection, and 4 supplementary applications of recombinant human growth hormone injection Application for injection supplement, application for import clinical trial of three therapeutic biological products semaglutide tablets MSD R & D (China) - 5 varieties There are 5 varieties registered and declared by MSD R & D (China), including 4 therapeutic biological products pembrolizumab injection (2 import applications have been approved for clinical use, 2 supplement applications), 6 supplement applications for pegylated interferon α - 2b injection, 4 supplement applications for recombinant human interferon α 2B injection, 6 supplement applications for inactivated hepatitis A vaccine (human diploid cells), 1 supplement application for four Supplementary application for human papillomavirus vaccine (Saccharomyces cerevisiae) Kylin Co., Ltd - 3 varieties Three varieties were registered and applied by kylin Co., Ltd., including two applications for clinical trial of imported treatment biological product broshumab injection, one application for clinical trial of imported treatment biological product baidarumab injection, and ten applications for recombinant human erythropoietin injection (CHO cells) (six supplementary applications and four import re registration applications) Lilly france-3 varieties Lilly France registered and applied for 3 varieties, including 4 applications for supplement of recombinant human insulin injection of protamine zinc, 4 applications for supplement of recombinant human insulin injection of protamine zinc, and 4 applications for supplement of recombinant human insulin injection Beijing Novartis - two varieties of Beijing Novartis registered and applied for two varieties, respectively, three applications for priority review of the import and marketing of therapeutic biological products, 11 applications for supplement of therapeutic biological products, and one application for import and re registration of therapeutic biological products and injection of baliximab Bristol Myers Squibb (China) - two varieties of Bristol Myers Squibb (China) are registered and applied for two varieties, respectively, eight applications for the import of nivolumab injection for therapeutic biological products (seven have been approved for clinical application), one supplementary application, and two injection of epimumumab (one has been approved for clinical application and one supplementary application) Nanyue bio - 4 varieties Nanyue bio registration application 4 varieties, respectively, are 2 new drug applications for therapeutic biological products of human prothrombin complex, 1 new drug application for therapeutic biological products of human coagulation factor Ⅷ 15, 4 supplementary applications for human albumin, 4 supplementary applications for intravenous injection of human immunoglobulin (pH4) Eli Lilly Nederland B.V - 2 varieties Eli Lilly Nederland B.V registered and applied for the import clinical trial of 4 priority review biological products dulaglutide injection, 7 recombinant insulin lysoprotein mixed injection (50R) (3 supplementary applications, 4 import re registration) F Hoffmann La Roche ltd-2 varieties F Hoffmann La Roche Ltd registered and applied for 2 varieties, respectively 9 atezolizumab injection (8 import applications, 1 supplementary application), 2 mpdl3280a injection supplementary application Sanofi pasteur-3 varieties Sanofi Pasteur applied for registration of 3 varieties, including 4 supplementary applications of Haemophilus influenzae type B combined vaccine, 4 supplementary applications of leucocyte free inactivated poliomyelitis and Haemophilus influenzae type B (combined) combined vaccine, and 2 supplementary applications of poliomyelitis inactivated vaccine Beijing Tiantan Biology - 9 species Beijing Tiantan Biological registration has applied for 9 varieties, including 1 supplementary application for Adsorbed Diphtheria Vaccine (for adults and adolescents), 1 supplementary application for adsorbed tetanus vaccine, 1 supplementary application for Adsorbed Diphtheria Tetanus Combined Vaccine, 1 supplementary application for Adsorbed Diphtheria Tetanus Combined Vaccine (for adults and adolescents), 1 supplementary application for adsorbed diphtheria vaccine, and 1 meningococcal group A Application for supplementation of polysaccharide vaccine, 1 application for supplementation of buffered normal saline, 1 application for supplementation of typhoid Vi polysaccharide vaccine, and 1 application for supplementation of adsorbed acellular pertussis combined vaccine Shanghai Institute of Biology - 7 varieties Shanghai Institute of biological products has registered and applied for 7 varieties, including 2 new drug applications for class I of influenza A virus split vaccine of biological products for prevention, 1 new drug application for class II of recombinant human mouse chimeric anti-CD20 monoclonal antibody injection of biological products for treatment, 1 new drug application for class II of recombinant anti HER2 humanized monoclonal antibody for injection of biological products for treatment, and 1 new drug application for biological products for prevention Application for 6 categories of new drugs of herpes zoster live attenuated vaccine, 2 categories of new drugs of pandemic influenza virus inactivated vaccine of biological products for prevention, 1 supplement application for varicella live attenuated vaccine, and 1 supplement application for mumps combined live attenuated vaccine Roche (China) - 5 varieties Roche (China) has applied for registration of 4 varieties, including 4 clinical trial applications for the import of therapeutic biological product emicizumab injection, 1 clinical trial application for the import of therapeutic biological product gantenerumab injection, 2 applications for the import of bevacizumab injection, 1 application for the import of therapeutic biological product crenezumab injection, and 1 application for the supplement of therapeutic biological product mpdl3280a injection Apply.