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Summary
SummaryIn August, CDE undertook a total of 1090 drug registration applications
For the first time, the 8 stock varieties have the consistency evaluation of the enterprise declaration
Kangfang Biological submits another application for the marketing of Paimrizumab injection
There are 15 types of imitation applications, and 1 type of import applications has not been approved for domestic use.
2 Class 1 new drugs were approved, 3 first imitation varieties were approved, 15 varieties ushered in the first review
CDE overall undertaking
CDE overall undertaking According to the statistics of the MED2.
0 Chinese Drug Evaluation Database of Minai.
com, in August 2021, the CDE undertook a total of 1090 drug registration applications
.
January-August 2021 CDE-organized drug registration applications (according to the acceptance number)
Consistency Evaluation Supplementary Application Undertaking
Consistency Evaluation Supplementary Application Undertaking In August 2021, the supplementary application for consistency evaluation of 48 varieties was undertaken by CDE
.
8 varieties are the first submission of supplementary applications for consistency evaluation: Azithromycin granules (Ⅱ), erythromycin enteric-coated tablets, progesterone soft capsules, lisinopril hydrochlorothiazide tablets, pantoprazole sodium enteric-coated capsules, cefaclor dispersion Tablets, methylene blue injection, ritodrine hydrochloride tablets
CDE supplementary application (consistency evaluation) variety undertaking in August
New drug application undertaking
New drug application undertaking In August 2021, 114 new drug applications were accepted by CDE
.
Among them, there are 81 new drugs in category 1, 22 improved new drugs in category 2, and 8 biosimilar drugs in category 3.
Zhongshan Kangfang Biologics then submitted a marketing application for Paimrizumab injection, which is speculated to be a new indication.
At present, the drug has been approved for the treatment of relapsed or refractory classic Hodgkin's lymphoma
.
Chia Tai Tianqing, Qilu Pharmaceutical and Anhui Anke Biological all have biosimilar applications
The status of domestic new drug listing applications in August
The status of domestic new drug clinical applications in August
Undertaking of imitation applications
Undertaking of imitation applications In August 2021, 110 varieties of imitation applications were undertaken by CDE, of which 15 varieties have not been approved domestically: idecalcidol soft capsules, baritinib tablets, perampanel tablets, favilavir tablets , Devenlafaxine Succinate Sustained Release Tablets, Idoxaban Tosylate Tablets, Liprodicaine Cream, Tedizolamide Phosphate Tablets, Regorafenib Tablets, Salmeterol Ticassone Inhalation Powder Fog, Shugeng Sodium Gluconate Injection, Bromhexine Hydrochloride Solution for Inhalation, Prasugrel Hydrochloride Tablets, High-purity Urotropin for Injection, Tedizolamide Phosphate for Injection
.
See the table below for details:
The status of domestic imitation applications in August
Import application undertaking
Import application undertaking In August 2021, the import applications of 49 varieties were undertaken by CDE
.
Among them, there are 32 class 1 new drugs, 6 class 2 improved new drugs, 5 class 5.
The status of import listing applications in August
The status of import clinical applications in August
Approval status
Approval statusIn August 2021, Chia Tai Tianqing Kang Prescription (Shanghai) Bio-Piplimumab Injection and Guangzhou Yuheng Bio-Sepalizumab Injection were approved for two new Class 1 drugs
44 generic drugs were approved, including Ecodextrin Peritoneal Dialysis Solution (Guangzhou Baxter Medical), Enzalutamide Soft Capsule (Jiangsu Haosen Pharmaceutical Group), Bupropion Hydrochloride Sustained Release Tablets (Ⅱ) (Yichang People) Fu Yaoye) and other varieties are the first domestic imitations approved
55 stock varieties have been reviewed by companies, including Azithromycin Granules (Changchun Leiyunshang Pharmaceutical), Aspirin Enteric-coated Tablets (Chenxin Pharmaceutical), Aminophylline Injection (Tianjin Jinyao Pharmaceutical), Ornidazole Dispersible Tablets ( Hunan Jiudian Pharmaceutical), Phenytoin Sodium Tablets (Suzhou Hongsen Pharmaceutical), Ioverol Injection (Jiangsu Hengrui Pharmaceutical), Glycerol Fructose Sodium Chloride Injection (Tianjin Jinyao Group Hubei Tianyao Pharmaceutical), Tartrate Torol Injection (Yichang Renfu Pharmaceutical), Nimesulide Dispersible Tablets (Hubei Shubang Pharmaceutical), Pitavastatin Calcium Dispersible Tablets (Zhejiang Jingxin Pharmaceutical), Cefpodoxime Proxetil Dry Suspension ( Hainan Sanye Meihao Pharmaceutical), Naloxone Hydrochloride Injection (Chengdu Yuandong Biopharmaceutical), Isoniazid Injection (Tianjin Jinyao Pharmaceutical), Norepinephrine Bitartrate Injection (Broad Pharmaceutical), Argentine for Injection Moxilin sodium and clavulanate potassium (North China Pharmaceutical) and other varieties were the first companies to have been evaluated
Approved status of listing application varieties and consistency evaluation varieties in August
