Junshi biological PD-1 monoclonal antibody applied for listing, and the first three generic drugs were approved

Abstract: in the first quarter of 2018, the application for drug registration showed a significant growth trend Junshi biological PD-1 monoclonal antibody trepril monoclonal antibody injection was applied for marketing Nanjing legendary biological car-t drug was approved for clinical application 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 March 2018, CDE undertook 678 drug registration applications, which continued to rise year on year On the whole, in the first quarter of 2018, drug registration applications showed a significant growth trend, with a high enthusiasm for new drug applications Figure 1: CDE applications for drug registration (by acceptance number) from October 2017 to March 2018 (data source: Med China drug review database 2.0, the same below) in March, 13 applications for conformity assessment entered CDE, involving 11 varieties, among which amlodipine besylate tablets, cefuroxime dipivoxil tablets and adefovir dipivoxil tablets have passed the conformity assessment Table 1: acceptance of generic drug conformity assessment in March 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! 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Im portant; "> CDE undertook 91 new drug applications in March, including 51 applications belonging to class 1 new drugs, involving 31 generic names of drugs Five kinds of products, including bivalent HPV vaccine of Xiamen Wantai Canghai biology, utidelong raw material and injection of Huahao Zhongtian Pharmaceutical Co., Ltd., rimazazolam toluene sulfonate raw material and injection of Hengrui medicine, treprizumab injection of Junshi biology and recombinant human endostatin injection of Jiangsu Wuzhong medicine, are listed applications, among which treprizumab injection of Junshi biology is China The second application for listing of PD-1 monoclonal antibody in China Some time ago, there was a message that Cinda biology withdrew its application for listing of PD-1 monoclonal antibody products At present, materials are being supplemented It is worth looking forward to who will be approved for listing in the end In addition, in March, the car-t drug ict19g1 of Shanghai stansai bio applied for clinical application Center; Border bottom width: 1px; border bottom color: rgb (0, 0, 0); box sizing: border box! 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Im assistant; "> in March, CDE undertook 81 generic applications involving 45 varieties, 19 of which are currently exclusive in China At present, docetaxel injection has 37 production approval documents from domestic manufacturers, while moxifloxacin hydrochloride raw materials have 42 applications under review, with fierce competition Table 3: processing of imitation application in March 2018 (only the acceptance numbers of application types "new drugs", "imitation" and "import" are counted in the application under review) 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 March, CDE undertook a total of 26 import applications involving 15 varieties, of which ivankasse tablet of kylin Co., Ltd was the first one undertaken by CDE In addition, several import varieties applied for listing in March See the table below for details Table 4: CDE import application in March 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; "> approval status Erbesartan hydrochlorothiazide tablets of Nanjing Zhengda Tianqing passed the consistency evaluation, becoming the second enterprise after Zhejiang Huahai Pharmaceutical Co., Ltd Nanjing legend's lcar-b38m car-t cell autotransfusion preparation (referred to as lcar-b38m cell preparation) has been approved for clinical use, becoming the first enterprise in China that has been approved for clinical use of car-t therapy drugs The flurbiprofen axetil injection of Wuhan Da'an Pharmaceutical Co., Ltd has been approved for listing, and is the first generic drug declared according to the new 3 categories, which is deemed to have passed the consistency evaluation The original research enterprise of the drug is Dazheng pharmaceutical, which is used for postoperative and cancer analgesia Previously, only Beijing Taide pharmaceutical was approved in 2004 Table 5: approval of some applications in March 2018