New developments in CDE drug review!

Main points of progress in drug review and approval this week

In the past week, the drug approval center accepted a total of 229, involving 168 varieties

23 clinical applications for Class 1 new drugs were accepted by CDE

Added 11 new acceptance numbers for application of generic drug quality and efficacy consistency evaluation varieties

27 varieties passed (including deemed passed) consistency evaluation, 10 models passed the first evaluation

Treatment "King of Children's Tumors"-Dituximab Injection Approved for Market

Reply to the keyword "CDE Accepted 20210822" to get the list of CDE accepted varieties this week

The data statistics period is from August 13th, 2021 to August 19th, 2021.

From August 1st to August 12th, 2021, a total of 4 imported drugs were approved for marketing, and 20 varieties passed (including deemed passing) consistency evaluation, including Tianjin Jinyao Pharmaceutical’s "Isoniazid Injection" ", Chengdu Yuandong Biopharmaceuticals "Naloxone Hydrochloride Injection" and Chenxin Pharmaceuticals "Aspirin Enteric-coated Tablets" and other 10 first imitations; BeiGene's Datuximab β was approved for the market to treat nerves For blastoma, the specific information is as follows:

3 varieties have been approved for production

3 varieties approved for import

BeiGene's Dituximab injection is a monoclonal antibody that binds to a specific GD2 target overexpressed on neuroblastoma cells

1) Treatment of high-risk neuroblastoma patients ≥12 months of age, these patients have previously received induction chemotherapy and have achieved at least partial remission, and have subsequently undergone myeloablative therapy and stem cell transplantation;

2) Treatment of relapsed or refractory neuroblastoma with or without residual disease

tip: Dituximab injection is the only targeted tumor immunotherapy approved by EMA for the treatment of high-risk neuroblastoma, and it is included in the first batch of clinically needed overseas new drugs in China

Amgen’s Apomilast tablets were first developed by Xinji under Bristol-Myers Squibb.

In March 2014, Apomilast was approved for marketing in the United States, and its indication was adult active psoriatic arthritis, under the trade name Otezla

Over-rated variety information

In the review and approval stage

According to the drug review data of Yaorongyun China, from August 13th to August 19th, a total of 168 drugs (based on varieties, the same below) were contracted by CDE, including 101 chemical drugs, 33 biological products, and 34 traditional Chinese medicines.

Recently, a total of 35 domestic new drugs have been accepted, and there are 26 varieties, all of which are clinical applications, including 23 new category 1 drugs

Application for clinical new drugs

At the approval stage

A total of 38 varieties (26 acceptance numbers) have entered the approval stage recently

Among them, the marketing application of Sepalizumab (GLS-010 injection) has entered the administrative examination and approval stage and will be approved for marketing soon

GLS-010 injection was commissioned by Yuheng Biologics to develop and jointly declare WuXi Biologics.

Consistency evaluation application

Recently, 11 varieties have submitted applications for consistency evaluation