 Home > Active Ingredient News > Drugs Articles > CDE Weekly Report on the Number of Improved New Drug Marketing Applications Sudden Increase!

CDE Weekly Report on the Number of Improved New Drug Marketing Applications Sudden Increase!

 Last Update: 2022-02-21
 Source: Internet
 Author: User

Tags

reel film

docp injection

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

Introduction: It's time for the weekly CDE weekly report again.
How about the innovative drugs and improved new drugs last week? See below for details (the statistical results in the text do not include supplementary application & import re-registration)
.

introduction:

Undertaking of innovative drugs

From January 10 to 16, 2022, CDE will undertake a total of 26 innovative drug acceptance numbers, including 12 chemical drug acceptance numbers, 13 biological product acceptance numbers, and 1 traditional Chinese medicine acceptance number
.

12 of the 26 chemical drug acceptance numbers, 13 biological product acceptance numbers, and 1 traditional Chinese medicine acceptance number

Among the 26 acceptance numbers, there are 24 clinical trial applications and 2 marketing registration applications
.

The 2 registration applications are for zebetumab injection (Zhejiang Borui Bio-Pharmaceutical Co.
, Ltd.
; Hisun Bio-Pharmaceutical Co.
, Ltd.
;)
.

According to the press release of Bori Bio, zebetuzumab is a novel anti-CD20 monoclonal antibody independently developed by the company .

Zebetuzumab injection, a new type of anti-CD20 mAb

Among the 26 acceptance numbers, there are 20 domestic drug acceptance numbers and 6 imported drug acceptance numbers
.

Undertaking of innovative drugs

Improved new drug undertaking

From January 10 to 16, 2022, CDE will undertake a total of 10 improved new drug acceptance numbers , including 9 chemical drug acceptance numbers, 1 biological product acceptance number , and no traditional Chinese medicine acceptance number
.

10 improved new drug acceptance numbers , 9 chemical drug acceptance numbers, and 1 biological product acceptance number

Among them, it is worth paying attention to the registration application of Lipin Pharmaceutical for aripiprazole oral dissolving film
.

According to the past data of CDE, the first company that has undertaken the application for registration of aripiprazole mouth-dissolving film products is Qilu Pharmaceutical

Lipin Pharmaceutical Aripiprazole Oral Dissolving Film

The only improved new drug for biological products is: Ruiki Orenza Injection (Shanghai WuXi Ju Nuo Biotechnology Co.
, Ltd.
)
.

Benoda (Ruiji Orenza Injection) is a CD19- targeting drug independently developed by WuXi Ju Nuo on the basis of the CAR-T cell technology platform of Ju Nuo Medical (a company of Bristol-Myers Squibb).

Autologous CAR-T cell immunotherapy product of biologics Ruiki Aurenzai injection CD19

Among the list of improved new drugs undertaken this time, 8 are applications for marketing registration , and only 2 are applications for clinical trials

8 applications for listing registration and 2 applications for clinical trials

Improved new drug undertaking

Consistency Evaluation Undertaking

From January 10th to 16th, 2022, CDE will undertake a total of 31 conformity evaluation acceptance numbers .

31 consistency evaluation acceptance numbers

Registration classification: 3 categories

Registration classification: 4 categories

Registration classification: 5 categories

This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.