CDE drug trial new dynamics! Bioproducts new drugs declared hot, Hengrui, Zhengda sunny, and the masses of biological ...

Introduction: CDE Drug Review Analysis Report, July. The total number of drug trial centers received in July
was 815 (excluding reviews).
July, 34 new drug varieties of class 1 of the chemical drug were accepted by CDE.
added 95 acceptance numbers in July to evaluate the quality and efficacy consistency of generic drugs.
According to the latest statistics of pharmaceutical data, in July 2020 CDE will undertake a total of 815 new drug registration applications with acceptance numbers (except review, the same below).
Figure I The number of CDE drug acceptances in March-July 2020 decreased by 334 acceptance numbers in July compared to June, of which 287 were received for chemical drugs.
below and the registration acceptance and evaluation of chemical drugs, Chinese medicine and biological products.
. CDE in July to undertake a total of 613 applications for registration of new chemical drugs with acceptance numbers.
Figure II The acceptance of applications for CDE chemical drugs in March-July 2020 from the declaration of chemical drugs, July's contract data compared to June, new drugs, imitation and supplementapplication applications have decreased significantly, of which the number of supplementary applications decreased by 295.
1. The declaration of domestic products of the 1st class of chemical drugs in July CDE accepted a total of 31 acceptance numbers for domestically produced 1 new drug, involving 15 varieties of 11 enterprises.
the table below is a new class of domestic new drugs in July.
Table I In July 2020, the newly-hosted New Domestic Drug Note: Line number ends on August 3, 2020.
ACT001 capsule ACT001 is an anti-tumor drug developed jointly by Tianjin Sunde Pharmaceutical Technology and Nankai University as a target statist 3 and NF-B,micheliolide.
malic acid famitini capsule is a small molecule multi-target tyrosine kinase inhibitor developed by Hengrui Pharmaceuticals, which has good inhibitory activity for a variety of receptor tyrosine kinases such as c-Kit, KDR, PDGFR, VEGFR3, Flt1, Flt3, c-Src, FGFR2, FGFR3 and PDGFR alpha.
, the drug is carrying out clinical studies on advanced solid tumors, nasopharyngeal cancer, gastrointestinal mesomas, neuroendocrine tumors, iexclusiveciatic fibrosis, colorectal cancer and many other indications.
HPG1860 capsule HPG1860 is a new drug of the original NASH of Yaton Pharmaceuticals, which is a non-bile acid structure, highly efficient, highly selective complete fenifol X receptor (FXR) agonis, with the potential to treat non-alcoholic fatty hepatitis (NASH), primary bile cirrhosis (PBC) and primary cirrhosis biliary itis (PSC).
PZH2111 tabletp2111 tablets are an innovative type 1 of chemicals with independent intellectual property rights, which is mainly used to treat endothelial cell cancer in urethra, biliary cell carcinoma and other advanced solid tumors.
Azftin tablet Azvedin (FNC) is the world's first target HIV reverse transcriptase and auxiliary protein Vif dual target inhibitor, the first anti-HIV oral drug with independent intellectual property rights in China, access to the country's "major new drug creation" technology major special support.
the drug will be marketed, will make great contributions to the treatment and prevention of AIDS in China.
Haiqupopa ethanolamine tablets haiquupa ethanolamine is a series of structural modifications carried out by Hengrui Pharmaceuticals on Aiqupopa, and developed an innovative drug with independent intellectual property rights, it is a highly selective non-peptide platelet-producing receptor (TPOR) agonists, which are mainly used in clinical treatment of platelet reduction.
Pamiparib (BGB-290) is an in-house PARP1 and PARP2 inhibitor developed by Baiji Shenzhou.
the drug is mainly used to treat patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received at least two lines of chemotherapy and have a disease-causing or suspected germ BRCA mutation.
2. The declaration of the 1st class of imported drugs of chemical drugs in July, a total of 40 imported chemical drugs class 1 acceptance number was received.
Table II New Lymics Class 1 Imported Drug Notes for July 2020: Line number ends on August 3, 2020.
、7CDE18,1,16,1。
Figure 3 March-July 2020 CDE Chinese medicine acceptance situation III, biological products review situation in July CDE to undertake a total of 184 new biological products registration application number, 64 new drugs, 56 supplementary applications, import 61, 3 one-time imports.
Figure IV The acceptance of CDE biological products in March-July 2020 July, 50 class 1 therapeutic biological products receiving numbers were received, and have now entered the corresponding sequence queue for trial.
Table III New Class 1 New Drug Note for Therapeutic Biologics, newly hosted in July 2020: Line number ends on August 3, 2020.
. Fourth, according to the consistency evaluation of the declaration of varieties in July, the addition of 95 in accordance with the consistency evaluation requirements for the declaration of the acceptance number.
(the length limit only shows consistency information, as follows and specific information please pay attention to the pharmaceutical enterprise version of the drug registration and acceptance database) Figure V January-July 2020 consistency evaluation acceptance number of the number of table 4 July 2020 new consistency evaluation note: queue number as of August 3, 2020.
source of data: database on the registration and acceptance of pharmaceutical sinnies.