The upsurge of car-t declaration is emerging, and 6 varieties have passed the consistency evaluation

Abstract: many car-t therapeutics have been accepted by CDE Four enterprises have submitted the application for the imitation of tenofovir fumarate dipivoxil tablets CFDA has announced the second batch of generic drug conformity evaluation announcement None = "shifumousedownstyle ('shifu_bus_002 ')" style = "margin: 1em Auto; padding: 0px; max width: 100%; color: rgb (62, 62, 62); font-family: "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif; font-size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> according to the statistics of MED China drug review database 2.0, in February 2018, there were 578 applications for drug registration undertaken by CDE In February, the applications for drug registration undertaken by CDE were not affected by the Spring Festival holiday, and the applications for drug registration undertaken by CDE increased year-on-year in January Figure 1: CDE applications for drug registration (by acceptance number) from September 2017 to February 2018 (data source: Med China drug review database 2.0, the same below) In February, 8 consistency evaluation applications were undertaken by CDE, involving 7 varieties, among which metformin hydrochloride sustained-release tablets and irbesartan tablets belong to non 289 categories Table 1: acceptance of generic drug conformity assessment in February 2018: none = "shifumousedownstyle ('shifu_bus_ ')" style = "margin: 1em Auto; padding: 0px; max width: 100%; color: rgb (62, 62, 62); font family:" hiragino sans GB "," Microsoft YaHei ", Arial, sans serif; font size: 16px; line height: 25.6px; width: 1; border style: none solid; Text align: Center; border bottom width: 1px; border bottom color: rgb (0, 0, 0); box sizing: border box! Im portant; word wrap: break word! Im portant; "> there are 95 new drug applications undertaken in China in February, of which 63 belong to class 1 NEW drug applications, involving 32 generic drug names, all of which are clinical applications Chongqing precision biology Co., Ltd., Shanghai Hengrun Dasheng biology Co., Ltd and Beijing Yimiao Medical Technology Co., Ltd all have one car-t therapy drug into CDE, while Shanghai yucadi biology Co., Ltd has another two car-t therapy drugs in February At present, the enterprise has three car-t therapy drugs into CDE Since the first car-t therapeutics was undertaken by CDE in December 2017, there are more than 10 car-t therapeutics under review by CDE In this paper, the author analyzes the characteristics of; Text align: Center; border bottom width: 1px; border bottom color: rgb (0, 0, 0); box sizing: border box! Im portant; word wrap: break word! Im portant; "> CDE undertook 94 generic drug applications in February, involving 53 varieties, 20 of which are currently exclusive in China At present, there are many domestic approvals for iohexol injection, ambroxol hydrochloride injection and metformin hydrochloride sustained-release tablets, showing signs of homogenization It is worth mentioning that in February, there were four enterprises that applied for the replication of tenofovir dipivoxil fumarate tablets to be undertaken by CDE As of the end of February 2018, two manufacturers have passed the generic drug consistency evaluation of the product At present, there are nine applications for the product under review, with fierce competition Table 3: processing of copy application in February 2018 (click to see the big picture) (only the application types in review are new drugs, copy and import acceptance No.) none = "shifumousedownstyle ('shifu bus_002 ')" style = "margin: 1em Auto; padding: 0px; max width: 100%; color: rgb (62, 62, 62); font family:" hiragino sans GB "," Microsoft YaHei ", Arial, sans serif; font size: 16px; line-height: 25.6px; widows: 1; border-style: none none solid; text-align: center; border-bottom-width: 1px; border-bottom-color: rgb(0, 0, 0); box-sizing: border-box !im portant; word-wrap: break-word !im portant; "> in February, CDE undertook 33 import applications involving 21 varieties, 7 of which were the first varieties undertaken by CDE Application for marketing of pabolizumab injection of mosadong, aletinib hydrochloride capsule of Roche and jetberine human albumin API 2; Text align: Center; border bottom width: 1px; border bottom color: rgb (0, 0, 0); box sizing: border box! Im assistant; word wrap: break word! Im assistant; "> in February, 6 varieties passed the consistency evaluation of generic drugs The production of paclitaxel for injection (albumin binding type) of Ouyi Pharmaceutical Co., Ltd of Sinopharm group was approved for the first time This application is a new type of 4-type imitation application, which is deemed to have passed the consistency evaluation At the same time, this product is the second injection that passed the consistency evaluation (pemetrexed disodium for injection of Sichuan Huiyu Pharmaceutical Co., Ltd passed the consistency evaluation for the first time) In addition, CFDA published the second batch of notices on the consistency evaluation of quality and efficacy of generic drugs in February This time, there are five varieties in total Jiangsu Huanghe Pharmaceutical Co., Ltd., a subsidiary of Fosun Pharmaceutical, became the first manufacturer to pass the consistency evaluation of amlodipine besylate tablets, and Qilu pharmaceutical became the second manufacturer to pass the consistency evaluation of tenofovir fumarate dipivoxil tablets after Zhengda Tianqing Table 5: approval of some applications in February 2018