In October, 5 Class 1 new drugs were reported for production, and 7 varieties were approved for new indications

Overall CDE Undertaking

 

According to the statistics of Minai.
com China Declaration Progress (MED) database, CDE undertook a total of 975 drug registration applications in October 2022
.

 

Status of CDE drug registration applications from January to October 2022 (by acceptance number)

Consistency evaluation of supplementary application undertaking

 

In October 2022, the supplementary application for consistency evaluation of 41 varieties was undertaken by CDE
.
Seven varieties, including lithium carbonate tablets, adenosine injection, nifedipine sustained-release tablets, dacarbazine for injection, methotrexate for injection, and indocyanine green for injection, are declared
for the first time.

 

CDE supplementary application (consistency evaluation) varieties in October

New drug application undertake

 

In October 2022, 100 varieties of new drug applications were undertaken by CDE
.
Among them, there are 73 class 1 new drugs, 18 class 2 improved new drugs, and 4 biosimilars
.

 

Haisco Class 1 new drug HSK16149 capsules, Suzhou Zejing Biotech Class 1 new drug jacktinib hydrochloride tablets, Kaixing Life Science and Technology Class 1 new drug Zewoki Orencel injection, Jiangsu Zhuohe Pharmaceutical Class 1.
1 Chinese proprietary medicine Feng Ye cough and asthma oral liquid and Chengdu Huaxi Natural Medicine Class 1.
1 Chinese proprietary medicine Pain and Wind Relief Granules were declared for marketing
.
Hengrui Pharmaceutical's pyrotinib maleate tablets and dalcilib isethionate tablets are new
indications.

 

Domestic new drug marketing application in October

 

Domestic new drug clinical application undertaking in October

 

Acceptance of imitation applications

 

In October 2022, the generic applications of 157 varieties were undertaken by CDE, including omega-3 fish oil medium and long chain fat emulsion/amino acid (16)/glucose (16%) injection, omega-3 fish oil medium and long chain fat emulsion/amino acid (16)/glucose (30%) injection, elamod tablets, eltrombopag olamine tablets, sulfamepride oral solution, amisulpride injection, olaparib tablets, calcium acetate oral solution, sodium acetate Ringer glucose injection, technetium [99mTc] vulcanized colloidal injection , clovidipine butyrate injection emulsion, irbesartan amlodipine tablets (I.
), irbesartan amlodipine tablets (III.
), compound polyethylene glycol electrolyte scatter (III.
), glycopyrronium bromide neostigmine injection, pimovanserin tartrate capsules.
.
.
and other 35 varieties, currently no domestic generic drugs have been approved
.

 

In October, domestic imitation application undertake, pictures, pictures, pictures, pictures

 

Acceptance of import applications

 

In October 2022, the import application of 31 varieties was undertaken by CDE
.
Among them, there are 14 Class 1 new drugs, 9 Class 2 improved new drugs, 5 Class 5.
1 imported original drugs, and 1 Class 5.
2 imported generic drug
.
AbbVie's upatinib sustained-release tablets are filed
for new indications.

 

Import listing application in October

 

Import clinical application undertaking in October

 

Approval

 

In October 2022, Hua Medicine's Class 1 new drug Docagliptin tablets were approved for marketing, and cyclopofol injection (Liaoning Haisco Pharmaceutical), relma-cel injection (JW Therapeutics Shanghai), serplulimab injection (Henlius Shanghai), tobramycin inhalation solution (Health Yuan Pharmaceutical Group), tofacitinib citrate tablets (Pfizer), ramoximab injection (Eli Lilly), pembrolizumab injection (Merck) and other varieties were approved for new indications
。 50 generic drugs have been approved for marketing (including imported 5.
2 classes), and idecalcidol soft capsules (Henan Taifeng Biotechnology), mabalosavir tablets (CSPC Ouyi Pharmaceutical), and ibrutinib capsules (Simcere Pharmaceutical) are the first generic varieties
in China.
43 stock varieties have been evaluated by enterprises, and 5 stock varieties, including ozagrel sodium injection, metformin glipizide tablets (II.
), erythromycin enteric-coated tablets, amikacin sulfate injection, and ozagrel sodium for injection, have been evaluated
by enterprises for the first time.

 

Approval of listing application varieties and consistency evaluation varieties in October

 

Data sources: MED2.
0 drug evaluation database, CDE, NMPA; The relevant statistical fields are counted by drug name, as of October 31, 2022; Drug targets and indications are compiled from public information
.