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    Home > Active Ingredient News > Drugs Articles > August 2020 Drug Registration Review and Approval Report.

    August 2020 Drug Registration Review and Approval Report.

    • Last Update: 2020-09-27
    • Source: Internet
    • Author: User
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    In August 2020, the drug registration review and approval report, August 2020 drug acceptance situation 1.2020 August acceptance of the general situation in August 2020, the State Drug Administration Drug Review Center (here is called the drug review center) received a total of 961 receiving numbers, an increase of 17.9% YoY, an increase of 39.9% Over the same period last year.
    2019 and 2020, chemical drugs accounted for 82%, biological products 15%, Chinese medicine 3%, of which 2 in-body diagnostic reagents.
    2 August 2020 acceptance of various drug types 2. The total number of chemical drug acceptances in August 2020 was 790.
    3 In August 2020, a total of 73 new acceptance numbers were declared for the acceptance of chemical drugs of various types of applications, including domestic and imported varieties.
    Figure IV August 2020 chemical drugs each registration classification acceptance situation this month newly declared a class of 1 chemical drugs a total of 23 varieties, involving 23 enterprises, this month a total of 20 new declared domestic innovative drugs varieties. Table
    1 of the newly registered clinical pharmaceutical innovation drugs in August, Minghui Pharmaceuticals (Shanghai) Co., Ltd., Lingke Pharmaceuticals (Hangzhou) Co., Ltd., Suzhou Xinxu Pharmaceutical Co., Ltd., Shandong Baiji Long Pharmaceutical Co., Ltd., Shanghai Runshi Pharmaceutical Technology Co., Ltd., Shenzhen Jin Ruiji Biotech Co., Ltd., Beijing Aitaipu Biopharmaceutical Technology Co., Ltd. and other 7 enterprises for the first time declared drugs.
    a total of 1 new Class 1 drugs were declared on the market this month.
    Vericiguat, a soluble bird nucleotide cyclic enzyme (sGC) developed jointly by Bayer and Mercedon for heart failure, has filed a listing application with the FDA, the European Union and Japan, and the FDA has accepted Vericiguat's new drug application (NDA) and granted it priority review eligibility.
    first domestic clinical declaration in 2015, the details of its clinical trials are as follows: Table 2 Vericiguat clinical trials carried out 2. Biological products acceptance in August 2020 a total of 138 biological products, mainly for therapeutic biological products.
    5 August 2020 Biological Products Acceptance This month, the declared heat of bio-innovative drugs remained high, with a total of 19 enterprises declaring 19 Class 1 biological drugs (Table 3). table
    Table 3 August newly registered clinical bio-innovative drug injection with wedisitto monoantigen anti-Rongchang biological independent research and development of injection with wedixito monoanti (previously used name: injection recombinant humanized antiHER2 monoantigen-MMAE coupled agent) is China's first independently developed antibody-drug association (ADC) into clinical development.
    for the drug, currently in the study of the adaptive diseases have breast cancer, urethra skin cancer, etc. , the application for the listing of the adaptive disease is presumed to be HER2 expression of stomach cancer.
    , the application for the listing of new drugs has been accepted by the State Drug Administration, and has entered the list to be included in the priority review, in the publicity stage.
    3. This month, Chinese medicine received 31 acceptance numbers, 25 of which were supplementary applications.
    Jiangsu Kangyuan Pharmaceutical Co., Ltd. declared a new class 1.2 Chinese medicine - Ginkgo terpenes.
    company Ginkgo terpene gluamine injection in 1998 set up research and development, after more than ten years of successful research and development, belongs to the original country of Chinese medicine 5 new drugs.
    The product is based on Ginkgo biloba as raw material, after extraction and purification to obtain its effective part of Ginkgo ginkgo glycerides A, B, K, etc., and as raw materials for injection, has been approved for market in 2012.
    the dosage form of this declared clinical is a drop pill, which was first declared clinical in 2005.
    , August 2020 Drug Review Completion In August 2020, the Drug Review Center completed a total of 584 new report task reviews, 439 chemical drugs, a total of 122 biological products, 23 Chinese medicine.
    Figure VI The completion of the review of various drug types in August 2020 1. The completion of the new chemical drug review in August completed 439 acceptance numbers, accounting for 75.2%, of which inD review completed 101 acceptance numbers and NDA completed 10 acceptance numbers.
    Figure VII The completion of the task review of the new chemical drug report in August 2020 in terms of the length of the review, the review rate of clinical trial applications remained highly efficient, including IND, supplementary application (clinical), and validated clinical, of which the average review time of IND was 68 days.
    NDA and ANDA reviews are relatively long and have a high chance of being replenished.
    Figure VIII August 2020 Chemical Drug New Report Task Review Time (days) Note: New Report Task Review Time Refers to the time it takes the Review Center to complete the new report review task 2. The completion of the review of therapeutic biological products this month completed the new report task review of therapeutic biological products 113 acceptance numbers.
    Figure 9 The completion of the task review of the new report on therapeutic biologics in August 2020 3.The completion of the review of Chinese medicine this month completed a total of 23 reviews of Chinese medicine, 20 supplementary applications, 3 Chinese medicine species review completed and approved for clinical trials (Table 4).
    Table 4 The market situation of Chinese medicines approved for clinical trials in March and August 2020 is incomplete, and this month the State Drug Administration approved a total of 99 drugs listed (by approval number), 65 generic drugs and 14 imported drugs.
    Table 5 in August approved the import of the original drug apatamine tablets in September 2019, apatamine tablets (trade name: Anson) were approved for the treatment of non-metastatic degenerative anti-prostate cancer (NM-CRPC) adult patients with a high risk of metastasis.
    , the new adaptation was approved by the State Drug Administration to treat adult patients with metastatic endocrine therapy for sensitive prostate cancer (mHSPC).
    August 2020, the National Drug Administration (NMPA) officially approved Gilead's Enrique Pentinaminofove tablets for hiv pre-exposure pre-exposure prevention (PrEP), becoming the first drug approved for PrEP in China.
    's Pentinofowe film was first released in China in December 2012.
    June 2020, Zhengda Tianqing Pharmaceutical Group Co., Ltd.'s first generic drug was officially approved, adaptive to be suitable for use with other antiretroviral drugs, the treatment of adults and children over 12 years of age (inclusive) HIV-1 infection.
    this month, Bayer Pharma's chlorinated radon injection was approved for sale by the State Drug Administration.
    the drug was first approved by the FDA on May 15, 2013 under the generic name Xofigo, for the treatment of late-stage desopathic bone metastasis against prostate cancer, and was first declared clinically in China in May 2012.
    November 2018, Bayer submitted a listing application for this product, which unfortunately was not approved.
    Tekmos particles Astellas submitted a clinical trial application for tekmos particles in February 2018, applying for adaptation to prevent transplant rejection after liver or kidney transplantation in children;
    approved for clinical practice in January 2019.
    Zoxi Mengdan injection Zoxi Mengdan injection is a patented drug developed and produced by Orion Corporation of Finland, which is suitable for short-term treatment of acute disprofusional heart failure (ADHF) that is not effective in traditional treatments and requires increased myocardial contraction.
    the product is the first original drug introduced by Hanguang Pharmaceuticals worldwide, and the company has been granted exclusive Chinese mainland the product in the market.
    .
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