2017 chemical registration application panoramic perspective, Hengrui, dongyangguang, Zhengda Tianqing and other famous enterprises

Highlights: 1 The 10-year development process of chemical drugs has changed from pursuing quantity to pursuing quality in recent years; 2 2018 will be the crucial year for 289 generic drug conformity assessment, with the latest release of 19 domestic specific varieties by CDE, helping the new process of conformity assessment; 3 New drug 1 (1.1) new drug increased by 34.57% year-on-year 4 The number of chemical injections is about one third of the total With the proposal of injection consistency evaluation, there is a long way to go in the future, and good ways need to be explored in time 5 Many famous chemical companies, such as Hengrui, dongyangguang, Zhengda Tianqing, etc., still performed well in 2017, and Zhejiang huahaicheng won the first batch of generic consistency evaluation I overall registration and application trend of chemicals In drug registration and declaration, the status of chemical drugs has been high, and its proportion has only a small fluctuation in 10 years Influenced by more stringent drug quality requirements, stricter market supervision and more clear policy guidance in recent years, the total number of drug registration and declaration in 2017 is not high, and the specific number of chemical registration and declaration is not the same as before Figure 1 overall registration and application of chemical drugs in 2008-2017 2 Chemical application type in 2017, the number of supplementary applications in chemical registration was the largest, 2214 (calculated by acceptance number, the same below), 389 new drug applications, a year-on-year decrease of 73.26%, 469 generic applications, a year-on-year decrease of 36.03% This situation has to be related to the launch of generic conformity assessment Since July 22, 2015, the State Council has clearly pointed out to speed up the consistency evaluation of generic drugs, and then CFDA has issued a series of supporting policies By the end of 2018, 289 varieties of consistency evaluation will be completed If not passed, the approval number of drugs will be cancelled, and the products will face off the shelf As a result, most of the energy in the past two years has been spent on improving generic drugs, especially in 2017, while 2018, as the last year, will be a critical year for 289 varieties to overcome difficulties and other varieties to strive to be superior   At the critical moment, the enterprise makes precise efforts, CFDA and CDE also give full play to their initiative and help customs clearance Yesterday (January 30), CDE issued the notice on further improving the consistency evaluation of domestic unique varieties in 289 base drug catalog, combing 19 unique varieties (see the end of the article for specific drug accessories), highlighting the focus and assisting the consistency evaluation Smooth progress and achieve the best results Figure 2 In 2017, there were 324 new drugs of category 1 (1.1) in the chemical registration application type registration classification (389 new drugs), with a year-on-year increase of 34.57% It can be seen that although the total number of new drugs is less than the past, the number of new drugs of category 1 (1.1) has increased compared with 2016, from which we can see the development trend of chemical drugs, and quality drugs will become the leading role in the future Figure 3: in 2017, the review and approval of chemical drugs in the registration and classification of new chemical drugs (III) CDE processing status has been completed by 50.89%, and the processing efficiency is similar to that of traditional Chinese medicine and biological drugs in the previous article Figure 4 chemical application status in 2017 IV application for registration of chemical application forms in 2017 are mainly tablets, injections, APIs and capsules It is worth mentioning that the total number of chemical injection is 1115, about one third of the total In December 2017, CDE issued a notice on Soliciting Opinions on technical requirements for conformity evaluation of listed chemical generic drugs (injections) Chemical injection will embark on the journey after the consistency evaluation of oral preparations Relevant enterprises are already exploring the most appropriate development path, which is a long way to go Figure 5 chemical application dosage form in 2017 5 Application enterprises in 2017 the number of chemical applications was more than that of Beijing Novartis and Jiangsu Hengrui, with only one acceptance number difference However, Jiangsu Hengrui has absolute advantage in new drugs, and is the most chemical new drug application enterprise Secondly, Guangdong dongyangguang, Zhengda Tianqing and other famous enterprises also performed well, not only in the top ten in the total number, but also in the top three in the number of new drugs Figure 6 ranking of chemical drug application companies in 2017 (Note: the application and registration rankings here only look at a single company, not the head office) Beijing Novartis - 3 chemical drugs category 1 import acceptance numbers Beijing Novartis has 74 acceptance numbers, including 3 imported drugs, 7 imported re registration, and the remaining 64 supplementary applications Among them, the import registration acceptance numbers of three chemicals class 1 lmb763 capsules have been approved for clinical use, and the supplementary applications of three tiralos dispersible tablets have also been approved for clinical use Two of LISS's clear and transdermal patches, three of oxcarbazepine tablets, and two of metformin and visgliptin tablets (II) have been approved for supplement Other acceptance numbers are still in progress or there is no conclusion Jiangsu Hengrui - 23 new drug acceptance numbers of Jiangsu Hengrui 73 acceptance numbers, 23 new drugs, 12 generic drugs, 38 supplementary applications Among them, 22 of 23 new drugs are chemical drugs of class 1, all of which are special approved varieties, pyrrolidine maleate tablets are also priority reviewed varieties, 1 new drug of class 2.2, and 9 acceptance numbers of chemical drugs of class 1 have been approved for clinical application, including 2 shr9146 tablets, 3 shr0532 tablets, 2 shr8554 injections, 2 shr1459 tablets In addition, there are three priority evaluation varieties in generic drugs, namely azilsartan tablets, temozolomide for injection and paclitaxel for injection (albumin binding type) Xi'an Janssen - 6 import re registration acceptance numbers Xi'an Janssen 49 acceptance numbers, there are 6 import re registration of procapride Succinate Tablets, which have been reviewed and approved, and the conclusion is not clear; 43 supplementary applications, 13 of which have been reviewed and approved, and the conclusion is not clear, which are itraconazole capsule, miconazole nitrate vaginal soft capsule, 2 risperidone tablets Three risperidone microspheres for injection, domperidone, three sustained-release tablets, flunarizine hydrochloride and tramadol Sichuan Kelun - 3 new drug acceptance numbers of 41 acceptance numbers of Sichuan Kelun, including 3 new drugs, 10 generic drugs, 20 supplementary applications and 8 reexamination Among them, two new drugs are chemical drugs of class 1 with special approval, including kl100137 API, kl100137 fat emulsion injection, and one cyclosporine fat emulsion injection of class 2.2 Guangdong dongyangguang - 20 new chemical class 1 drugs have been approved in the 33 acceptance numbers applied by Guangdong dongyangguang in 2017, 20 new chemical class 1 drugs have been approved in the clinical application, and all of them have been approved in the clinical application; 8 generic drug applications reported for production are in the review and approval, respectively 2 olmesartan tablets and priority review varieties Moxifloxacin hydrochloride tablets, 2 levofloxacin tablets, 2 clarithromycin tablets, clarithromycin sustained-release tablets; in addition, there are 5 supplementary applications Qilu pharmaceutical - among the 33 acceptance numbers of 3 new chemical drugs of category 1, Qilu pharmaceutical has 3 new chemical drugs of category 1, 17 generic drugs, 11 supplementary applications and 2 reexamination Among them, the approved clinical drugs are: the special approved ql-007 and its two tablets, the supplement application of two tegio capsules, and the review of two montelukast sodium oral dissolution membranes Zhengda Tianqing - 12 new drug acceptance numbers of Zhengda Tianqing 30 acceptance numbers, 12 of which are chemical class 1 new drugs, 12 generic drugs, and 5 supplementary applications Among them, tq-a3326 tablets have been approved for clinical use In addition, the Anda application and adefovir dipivoxil capsule supplement application of 6 generic drugs of lenalidomide capsule of Zhengda Tianqing have been reviewed and approved, indicating that they are not approved Jiangsu Haosen - among the 30 acceptance numbers of 3 class 1 new drugs, 3 are class 1 new drugs, 12 generic drugs and 15 supplementary applications In the application for supplement, desetabine for injection has been approved for supplement, recotinib maleate tablets and pemetrexed disodium for injection have also been reviewed and approved, and the conclusion is unclear temporarily Other drugs are still under review and approval Zhejiang Huahai - among the 28 acceptance numbers of the first batch of 9 product specifications that have passed the consistency Zhejiang Huahai, 17 generic drugs and 11 supplementary applications, among which 9 product specifications and 7 varieties are the first batch of drugs that have passed the consistency evaluation, making full use of the opportunity They are irbesartan tablets, fosinopril sodium tablets, two lisinopril tablets, two losartan potassium tablets, irbesartan hydrochlorothiazide tablets, risperidone tablets and paroxetine hydrochloride tablets In addition to these seven varieties of drugs, other drugs are still under review and approval Ouyi Pharmaceutical Co., Ltd - 17 acceptance numbers of generic drugs, of which 17 are generic drugs and 9 are supplementary applications At present, the generic application of metformin hydrochloride tablets and the generic anda application of three dasatinib tablets are not approved Appendix: CDE released the list of domestic unique varieties in 289 base drug catalogue on January 30, 2018