Of the 1397 varieties reviewed, Pfizer, Novartis, GSK, China biopharmaceutical, etc. who declared the most?

CDE mid-2018 inventory: 1770 variety applications were undertaken and 1397 varieties were reviewed; Pfizer's 8 new application varieties ranked first in the application, followed by Novartis, GSK and China Biopharmaceutics; nervous system and cardiovascular fields were the hot application fields in the first half of 2018; the number of chemical import applications decreased and the number of class 1 new drug applications increased slightly Source: half of insight database in dingxiangyuan has passed in 2018 The CDE drug review report of insight database in the middle of the year combs the data of CDE drug declaration and review from January to June 2018 The statistical data of this paper comes from the insight database of dingxiangyuan The statistical latitudes are all varieties The enterprises are calculated according to the parent enterprise The data statistical deadline is June 30, 2018, and the time is subject to the CDE undertaking time 1 Application acceptance: according to the statistics of insight database of DXY, CDE undertook 3553 acceptance numbers in 2018, involving 1770 drug varieties, an increase of 62% over the previous year (1092 varieties last year), and about 300 varieties each month Compared with the varieties declared every month in 2017, there is not a small increase every month this year, which may be closely related to the settlement of drug backlog acceptance Since the policy was introduced in 2015, the number of monthly contractors has plummeted, and now the number of varieties has begun to rise Chemical drugs account for nearly 80% of the drugs declared each month Let's first look at the application acceptance of chemical drugs In the first half of this year, it undertook 1329 chemical drug varieties In the first half of this year, it undertook 1329 chemical drug varieties, of which 1274 were declared according to the registration classification of the new version in 2016, and 55 were declared according to the registration classification of the old version in 2007, most of which were accepted by CFDA in 2014 In the first half of 2018, among the chemical drugs undertaken by CDE, 188 varieties (513 acceptance numbers) were listed applications, and 119 varieties (268 varieties) were clinical applications From the category of declaration, as shown in the figure below: supplementary application is the most important part of the declaration type Meanwhile, it is worth noting that in the first half of this year, the number of new drugs declared exceeded the number of imported drugs In the first half of the first half of the year, Pfizer ranked first among the eight new varieties declared by Pfizer, while Novartis ranked second this year China biopharmaceutical ranked third with four newly declared varieties, namely tqb3474, polymyxin E, tqa3526 declared by Zhengda Tianqing and fhnd9041 declared by Zhengda Fenghai pharmaceutical There are 67 varieties of new drugs of chemical category 1, 4 more than last year In the first half of 2018, there are 67 applications for new drugs of chemical category 1 The new drug team is growing constantly Compared with last year, there is no rule to follow in the number of new drugs of category 1 declared every month this year The number of imported chemicals undertaking 71 varieties has declined compared with that of last year In the first half of this year, the number of imported chemicals declared was 71 In May, the number of imported chemicals undertaking in the first half of 2018 was lower than that in the same period of 2017 In June 2018, there was a small peak in drug declaration, and the number of imported chemicals declared in that month was 25 This may be related to the decision to adjust the registration and administration of imported drugs issued in succession this year, which encourages the declaration of imported drugs The field of nervous system and cardiovascular system is the hot application field in the first half of 2018 According to the treatment field screening function of the varieties declared in insight database, we have made the review and approval of 14 treatment fields in the first half of this year As can be seen from the above figure, in the first half of the year, more than 20 varieties of treatment fields registered include cardiovascular system, nervous system, antibacterial drugs and anti-tumor These four areas are also the hot areas for application in 2017 It can be seen that at present, cardiovascular system, nervous system, antibacterial drugs and anti-tumor are still the hot areas for application in China 2 Overall review and approval in the first half of 2018, a total of 1397 drug varieties were reviewed, about 20% less than the same period last year (1734 varieties were reviewed last year) The main reason may be that the backlog of drug registration applications has been eased According to the application and completion review from January to June, in June 2018, the balance between registration application and completion review can be basically achieved Next, we will look at the approval of chemical drug listing application Compared with 2017, the queues of chemical drug ind review and confirmatory clinical review in the first half of 2018 are mainly concentrated in Anda, supplementary application and ind According to the consistency evaluation standard, priority examination and approval for generic drugs is up to the opinions of the General Administration on encouraging drug innovation to implement priority examination and approval issued in December 2017, which makes it clear that some drugs can obtain the priority examination and approval qualification Compared with last year, in six priority review categories of synchronous application in Europe and the United States, major special projects, rare diseases, children's drugs, and domestic generic drugs that have been listed in foreign countries simultaneously, and generic drugs that have been listed in conformity assessment standards, more drugs have obtained the priority review and approval qualification In 2018, there are 11 categories of priority review categories without corresponding priority review varieties in the first half of the year, which are patent application varieties before expiration, viral hepatitis, malignant tumor, clinical urgent need / market shortage, first application varieties, first imitation varieties, phase II / III clinical trial applications, anti hepatitis C drugs, hepatitis B treatment drugs, AIDS treatment drugs and car-t Therapy 3 The first half of the year approved the launch of the heavy-duty product "thipefigstein" of Hengrui Thiopefigeristine is a polyethylene glycol recombinant human granulocyte stimulating factor independently developed by Hengrui It is applicable to reduce the incidence of infection manifested by febrile neutropenia when patients with non osteomyelic cancer are treated with bone marrow suppressive anticancer drugs that are easy to cause clinically significant febrile neutropenia Amgen's peifeigeting has been listed in the United States, Japan, the European Union and other countries and regions, but not in China In 2017, the global sales volume of peferistine was about 4.76 billion US dollars, and the domestic sales volume of pegylated recombinant human granulocyte stimulating factor injection was about 75.986 million US dollars Zhengda Tianqing "androtinib" androtinib is a new type of small molecule and multi-target tyrosine kinase inhibitor (TKI), which can effectively inhibit vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR), c-kit Isokinases can inhibit tumor angiogenesis and tumor growth It can be used to treat lung cancer, colorectal cancer, renal cancer, soft tissue sarcoma, thyroid cancer, gastric cancer and so on It took only 9 days from the submission of the application to the conditional approval for the listing of the 9-valent HPV vaccine, which indicates that China's cervical cancer vaccine is officially in line with the international standard The vaccine is used to prevent cervical cancer, vulvar cancer, vaginal cancer, anal cancer, genital warts, persistent infection, precancerous lesions or atypical lesions caused by HPV It is suitable for women aged 16 to 26 years.