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Summary
SummaryIn October, CDE undertook a total of 915 applications for drug registration
For the first time, the 7 stock varieties have the consistency evaluation of the enterprise declaration
Two blockbuster Class 1 new drugs were first declared for listing
Zejing Bio-Donafenib Toluenesulfonate Tablets New Indications Reported for Production
17 varieties apply for imitation, 2 varieties apply for import 5.
2 category
Microcore Diabetes Class 1 new drug Siglita Sodium Tablets Approved for Marketing
6 first imitation varieties were approved, and 2 stock varieties welcomed the first review
CDE overall undertaking
CDE overall undertaking According to the statistics of the MED2.
0 Chinese Drug Evaluation Database of Minenet.
com, in October 2021, CDE undertook a total of 915 drug registration applications
.
January-October 2021 CDE-organized drug registration application status (according to the acceptance number)
Consistency Evaluation Supplementary Application Undertaking
Consistency Evaluation Supplementary Application Undertaking In October 2021, the supplementary application for consistency evaluation of 43 varieties was undertaken by CDE
.
Seven varieties are the first submission of supplementary applications for consistency evaluation: Citicoline Sodium Injection, Compound α-keto Acid Tablets, Compound Glycyrrhizin Tablets, Mecobalamin Dispersible Tablets, Loxoprofen Sodium Dispersible Tablets, Tirofen Hydrochloride Feban concentrated solution for injection, venlafaxine hydrochloride tablets
October CDE Supplementary Application (Consistency Evaluation) Variety Undertaking Status
New drug application undertaking
New drug application undertaking In October 2021, 104 new drug applications were accepted by CDE
.
Among them, there are 76 class 1 new drugs, 22 class 2 improved new drugs, and 2 class 3.
Xuanzhu (Beijing) Pharmaceutical Technology submitted an application for the marketing of proton pump inhibitor Anaprazole sodium enteric-coated tablets
.
Lepu Biotechnology and Zhaoke Tumor Drugs each have a PD-(L)1 monoclonal antibody applied for listing
Undertaking of domestic new drug listing applications in October
The status of domestic new drug clinical applications in October
Undertaking of imitation applications
Undertaking of imitation applications In October 2021, 88 varieties of imitation applications were undertaken by CDE, of which 17 varieties have not been approved domestically: Apomilast tablets, amlodipine benazepril capsules, olaparib tablets, diquafossol Sodium eye drops, fenofibrate tablets (Ⅲ), fluconazole dry suspension, haloperidol oral solution, dimethyl fumarate enteric-coated capsules, cyclophosphamide capsules, lysine profen injection , Oseltamivir phosphate dry syrup, nilotinib capsules, peramivir injection, sugammadex sodium injection, terlipressin injection, clonidine hydrochloride sustained-release tablets, bromhexine hydrochloride oral Liquid
.
Among them, Apmilast has three corporate layouts, and the details are shown in the table below:
Domestic imitation application undertaking in October
Import application undertaking
Import application undertaking In October 2021, import applications for 36 varieties were undertaken by CDE
.
Among them, there are 15 class 1 new drugs, 10 class 2 improved new drugs, 6 class 5.
Status of application for import listing in October
The status of import clinical applications in October
Approval status
Approval status In October 2021, Chengdu Microchip Pharmaceuticals' new class 1 diabetes drug Siglita sodium tablets was approved for marketing
.
Nanjing Youke Pharmaceutical and Shanghai Yizhong Biology each have an improved new drug approved
59 generic drugs have been approved (including imported category 5.
The 35 stock varieties passed the consistency evaluation, among which sodium hyaluronate injection (Huaxi Biotechnology) and Laoxycephalosporin sodium for injection (Hainan Hailing Chemical Pharmaceutical) were the first companies to be evaluated
Approval of the variety of application for marketing and the variety of consistency evaluation in October
Data source: Meinenet MED2.
