New developments in CDE drug review! GLP-1, SGLT2, FGFR multi-target new drug pile acceptance, Hengrui, Xinlitai, Lilly...

Introduction: Analysis report on CDE drug review in August.
the total number of drug review centers received in August was 959 (not counting review).
, 44 new class 1 drugs were accepted by CDE.
, 82 new acceptance numbers were added for the declaration of varieties evaluated on the quality and efficacy of generic drugs.
according to the latest statistics of pharmaceutical data, in August 2020 CDE hosted a total of 959 new drug registration applications with acceptance numbers (except for review, the same below).
2020 CDE drug reception increased by 144 reception numbers compared to August 2020, of which 177 were chemical drugs.
the following and look at the registration and acceptance and review of chemical, Chinese and biological products.
, chemical drug review situation in August CDE to undertake a total of 790 new chemical drug registration applications to accept the number.
Figure 2 April-August 2020 CDE chemical drug application type acceptance from the chemical drug declaration, August's contractor data compared to July, all types of applications in addition to new drugs and supplementary applications have different degrees of decline.
1. Chemical drugs 1 category of domestic declaration situation in August CDE accepted chemical drugs domestic 1 category of new drugs a total of 73 acceptance numbers, involving 33 varieties of 28 enterprises.
table below shows the new category 1 domestically produced new drugs in August.
, August 2020 newly hosted chemical drugs 1 new domestic drug note: queue number until September 1, 2020.
SHR1459 SHR1459 tablets are drugs developed by Ruishi Biopharmaceutical Co., Ltd. for the treatment of optic neurospinal cord disease spectrum disease, the product has been invested in research and development costs of about 67.76 million yuan.
S086 S086 is a hemangiotrophine II subject-brain morphinease double inhibitor developed by Xinlitai, which is tentatively defined as: chronic heart failure in adult patients, reducing the risk of cardiovascular death and hospitalization of heart failure.
HSK3486 emulsion HSK3486 is a new intravenous anesthetic drug with independent intellectual property rights developed by Sichuan Haisco Pharmaceutical Co., Ltd., which is intended to be used for surgical whole hemp induction, endoscopic sedation/anesthesia, ICU sedation and other adaptations.
CYH33 tablet CYH33 is a new structure drug developed by Haihe Biology in cooperation with the Shanghai Institute of Pharmaceutical Research of the Chinese Academy of Sciences with the global independent intellectual property rights of PI3K alpha selective inhibitors.
PZH2109 capsule PZH2109 capsule is a class 1 innovative drug of chemicals with independent intellectual property rights of the company, which is mainly used to treat non-alcoholic fatty hepatitis, currently in the United States and China do not have the same target of the same adaptive drug was approved for market.
so far, the company has invested a total of about 25 million yuan in research and development of the drug project.
ASC40 tablet ASC40 is a non-alcoholic fatty hepatitis (NASH) candidate developed by Goliath Pharmaceuticals, the world's only oral fatty acid synthase (Fatty Acid Synthase, FASN) extractor.
proline Hengle net proline Hengle net tablet is Hengrui Pharmaceuticals independently developed SGLT2 inhibitor class of new drugs, intended for the treatment of type 2 diabetes.
Tirzepatide injection Tirzepatide is a gastric-suppressing peptide (GIP)/glutatroglycemic peptide-1 (GLP-1) complex double agonist developed by Lilly.
the drug has been approved in China for a number of clinical trials.
Infigratinib capsule Infigratinib is a selective FGFR inhibitor developed by Otto Bio and is currently in the clinical stage for the treatment of diseases such as bile tube cancer (CCA) and urethra (bladder cancer) caused by abnormal FGFR genes.
2. The declaration of imported drugs in category 1 of chemical drugs was received in August with a total of 25 imported drugs in category 1 acceptance numbers. form
II August 2020 newly undertaken chemical drugs 1 category of imported drug notes: queue serial number as of September 1, 2020, Chinese medicine review situation in August CDE to undertake a new Chinese medicine registration application acceptance number of a total of 31, of which 2 new drugs, 25 supplementary applications, imitation of one, one one-time import of 3.
Figure III April-August 2020 CDE Chinese medicine acceptance situation III, biological products review situation in August CDE to undertake new biological products registration application acceptance number a total of 138, 31 new drugs, 92 supplementary applications, 9 imports, 6 one-time imports.
4 April-August 2020 CDE biological products acceptance in August, 37 category 1 therapeutic biological products acceptance numbers were accepted, have now entered the corresponding sequence queue for trial.
Table 3 New Drug Note 1 for Therapeutic Biologics, August 2020: Queue No. 1 until September 1, 2020.
, according to the consistent evaluation of the declaration of varieties in August, the addition of 82 in accordance with the consistency evaluation requirements for the declaration of the acceptance number.
(Space limit only display consistency information, like and specific information please pay attention to the pharmaceutical industry version of the drug registration and acceptance database) Figure V January-August 2020 consistency evaluation acceptance number table IV August 2020 new consistency evaluation note: queue number until September 1, 2020.
data source: Pharmaceutical Registration and Acceptance Database.