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    Home > Medical News > Latest Medical News > Analysis report on CDE drug review in August 2017

    Analysis report on CDE drug review in August 2017

    • Last Update: 2017-09-08
    • Source: Internet
    • Author: User
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    Highlights: 1 The total number of drug audit centers accepted this month is 463 (excluding reexamination) 2 This month, a total of 12 new drugs of category 1 of domestic drugs have been declared, including two new drugs of category 1 of imported drugs and two new drugs of category 1 of domestic drugs 3 Three holding subsidiaries of Fosun Pharmaceutical applied for class 1 drugs 4 The listing application of pyrrolidine maleate tablets of Hengrui medicine was undertaken by CDE According to the latest statistics of drug intelligence database, in August 2017, CDE undertook 463 new drug registration applications with the acceptance number (excluding reexamination, the same below) Figure 1: the acceptance of CDE drugs in January August 2017 increased 46 acceptance numbers this month compared with July, up 74.7% compared with the same period last year Among them, 368 were chemical drugs, 33 were traditional Chinese medicine, 58 were biological products, 1 was in vitro diagnostic reagent, and 3 were pharmaceutical excipients Let's analyze the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products In August, CDE undertook 368 new chemical registration applications with acceptance number Fig 2 acceptance of CDE chemical drugs in various application types from April to August 2017 in the field of chemical drugs, the total number of chemical drug registration applications in this month increased by 37 acceptance numbers compared with June, the number of new drugs, imports and imitations decreased, and the supplementary applications continued to stay high Figure 3: the number of new chemical drugs accepted by CDE in 2016-2017 began to decline after the work plan of chemical drug registration and classification reform issued by the State Administration of drug administration in March 2016 By November 2016, the number of new drugs accepted by CDE decreased rapidly from 111 in January 2016 to 9, and rose slowly in 2017 In terms of quantity, although there is no significant increase, the gold content of new chemical drugs is greatly increased, which is a real new drug 1 Application of chemical medicine class 1: CDE accepted 28 acceptance numbers of chemical medicine class 1 this month, involving 11 enterprises of 12 varieties The figure below shows the new class 1 new drugs in August Table I new chemical class 1 drugs newly undertaken in August 2017 note: 1 The queue number is up to September 6, 2017; 2 "*" is a special approved variety Jiangsu Hengrui Pharmaceutical Co., Ltd has applied for the clinical trial of chemical medicine class 1 new drug shr9549 and tablet, which has been undertaken by the drug Audit Center, and no relevant information has been found at present Another new chemical drug, pyrrolidine maleate, has also been accepted by CDE It was first applied for clinical application in May 2011 After six years, it finally submitted an application for listing Cyh33 tablet, a new chemical medicine of class 1, of Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences, is not the first application In May 2017, it was applied for API and tablet, and the acceptance numbers of two tablets were applied for this time It is speculated that it should be the other two different preparation specifications Cyh33 is a selective inhibitor of PI3K α PI3K α has a high frequency activation mutation in breast cancer, which is closely related to the occurrence and development of breast cancer and drug resistance, and has become an important target for the treatment of breast cancer Ro7020531 and capsule are class 1 new drugs developed by Roche company The clinical trial application has been accepted by CDE, and now they have been queued in the ind sequence for approval According to the drug clinical trial database of yaozhi.com, the drug has carried out phase I clinical trials in New Zealand and is in recruitment status According to its clinical trials, it is used to treat chronic hepatitis B Table II data source of relevant clinical trial information of ro7020531: drug clinical trial database, with ro7020531 as drug name for retrieval The fcn-437c capsule and its API developed by Chongqing fuchuang Pharmaceutical Research Co., Ltd., a holding subsidiary of Shanghai Fuxing Pharmaceutical (Group) Co., Ltd., were accepted by the drug approval center Cn-437c is mainly used in the treatment of solid tumors by inhibiting the proliferation of tumor cells The new drug showed strong in vitro and in vivo activity, good pharmacokinetic characteristics and safety in preclinical research (from its listing announcement) The application for fn-1501 and injection clinical trial of another holding subsidiary of Fosun Pharma, Shanghai Fosun Pharma Technology Co., Ltd., has also been accepted This product is an innovative small molecule chemical drug introduced from outside and independently developed by Fosun Pharma, which is mainly used for leukemia treatment (from its listing announcement) This month, Zhengda Tianqing Pharmaceutical Group Co., Ltd applied for two new drugs of category 1 - tq05510 and tqb3456, among which tq05510 applied for capsule in July and API was accepted in August Zhejiang Pharmaceutical Co., Ltd and Taijing pharmaceutical R & D (Beijing) Co., Ltd have jointly applied for the listing application of nanofloxacin malate and sodium chloride injection, with the specifications of 250ml (0.5g and sodium chloride of nanofloxacin malate (calculated according to c20h25n304) 2.25g), and it has broad-spectrum biological activity against Gram-negative bacteria, Gram-positive bacteria and atypical pathogens Moreover, it is resistant to methicillin-resistant Staphylococcus aureus (MRSA) It can be used as a first-line drug for community acquired pneumonia, and has the ductility of other indications (from its listing announcement) 2 Declaration of chemical medicine category 1 imported drugs 2 imported chemical medicine category 1 drugs were undertaken this month Table 3: chemical medicine category 1 imported drugs newly undertaken in August 2017 note: 1 The queue number is up to September 6, 2017; 2 "*" is a special approved variety According to the global drug R & D database (beta version) of yaozhi.com, ceniriviroc mesalate declared by eljian information consulting (Shanghai) Co., Ltd is used to treat HIV infection, nonalcoholic steatohepatitis (NASH) and obesity In 2015, the compound won the US fast track qualification for the treatment of nonalcoholic steatohepatitis (NASH) The compound was initially developed by Takeda pharmaceutical In 2007, Takeda pharmaceutical and tobira reached an agreement to jointly develop the compound Gsk3389404 injection, a new drug of GlaxoSmithKline (China) Investment Co., Ltd., is used to treat hepatitis B through searching the drug clinical trial database of yaozhi.com, the drug has completed phase I clinical trial in the UK, phase II clinical trial is being carried out in Hong Kong and South Korea, Hong Kong is in the recruitment state, and South Korea has not yet started recruitment Table IV relevant clinical trial information of gsk3389404 data source: drug clinical trial database, with gsk3389404 as drug name for retrieval In August, CDE undertook 33 new applications for registration of traditional Chinese medicine, including 6 new drugs, 26 supplementary applications and 1 re registration for import Figure 4 acceptance of CDE traditional Chinese medicine from April to August 2017 3 In August, CDE undertook a total of 58 applications for registration of new biological products, 22 new drugs, 19 supplementary applications, 9 imports and 8 re imports Figure 5 acceptance of CDE biological products from April to August 2017 nine class 1 therapeutic biological products were accepted this month, and now they have entered the corresponding queue for approval Table 5 class 1 new drugs of therapeutic biological products newly undertaken in August 2017 note: 1 The queue number is up to September 6, 2017; 2 "*" is a special approved variety The recombinant anti-PD-1 humanized monoclonal antibody injection developed by Shanghai Fuhong Hanlin Biotechnology Co., Ltd for solid tumor treatment was accepted by the drug approval center for solid tumor treatment At present, the recombinant anti-PD-1 humanized monoclonal antibody injection has been listed in the world, including opdivo and keytruda The approved clinical PD-1 antibodies in China are recombinant humanized anti-PD-1 monoclonal antibody injection of monarch, ibi308 developed by Cinda biology and shr-1210 of Hengrui Data source: drug intelligence registration and acceptance database note: the intellectual property rights of the above articles are owned by drug intelligence If you need to reprint, please indicate the source and the link of this article Click to download the report: analysis report of CDE drug review in August 2017.pdf
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