echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Medical World News > In 2019, 123 non-marketed drugs in China received priority review, Dongyang Sunshine, CSPC, etc. lead the way!

    In 2019, 123 non-marketed drugs in China received priority review, Dongyang Sunshine, CSPC, etc. lead the way!

    • Last Update: 2020-02-25
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    April Chen CFDA issued the opinions of the General Administration on solving the backlog of drug registration applications for priority review and approval (sfjhg [2016] No 19) and the opinions of the General Administration on encouraging the implementation of priority review and approval of drug innovation (sfjhg [2017] No 126) on February 26, 2016 and December 28, 2017, marking that the "priority review" system is to solve the problem With the backlog of registration applications as the main task, the company began to accelerate the R & D and marketing of new drugs with clinical value and clinical urgently needed generic drugs For drugs included in the priority review, there is an opportunity to enter the clinical or market as early as possible In 2019, 123 drugs not listed in China will be included in the priority review and approval of the national drug review center, and the review types include new drug listing, import listing and clinical application From the perspective of drug types, the drugs that are not listed in China and included in the priority review in 2019 are mainly chemical drugs Among 69 generic drugs, there are 3 categories: domestic applicants copy 25 drugs that are listed overseas but not listed in China; 4 categories: domestic applicants copy 44 drugs that are listed in China Figure 1 drug types and application types not listed in China for priority review in 2019 Among the 14 new chemical drugs included in the priority review in 2019, class 1: 10 innovative drugs not listed at home and abroad; class 2: 4 improved new drugs not listed at home and abroad There are two new chemotherapeutic drugs that were included in the priority review in 2019 and approved in the same year One is nilaparil p-toluenesulfonate It took 11 months from January 18, 2019 to December 27, 2019 The indications were maintenance treatment for adult patients with recurrent epithelial ovarian cancer, salpingocarcinoma or primary peritoneal ovarian cancer who were completely or partially relieved by platinum chemotherapy New indications of xidabamide: treatment of patients with hormone receptor positive, human epidermal growth factor receptor-2 negative, postmenopausal, local advanced or metastatic breast cancer recurred or progressed through endocrine therapy, from January 18, 2019 to November 29, 2019, lasting for 10 months Table 1 new chemical drugs to be listed in the priority review in 2019 13 imported chemicals were included in the priority review in 2019, among which about 70% of the original drugs listed in category 5.1 overseas accounted for Figure 2 types of imported drugs included in the priority review in 2019 Novartis sinimod tablet is the only imported class 1 innovative drug not listed at home and abroad that was included in the priority review in 2019 It is the second sphingosine-1-phosphate receptor next to fengomod Receptor, sipr), the first listed drug for the treatment of secondary progressive multiple sclerosis, was accepted in China on February 18, 2019, approved by the U.S FDA as early as March 26, 2019, and included in the priority review channel as a rare disease drug in May 2019 Table 2 new chemical drugs applied for import into priority review in 2019 Two new therapeutic bioproducts were included in the priority review in 2019 Taitacip is a taci-fc fusion protein for the treatment of lupus erythematosus It has a new drug structure and double target mechanism It can inhibit the differentiation and maturation of BLyS and April B lymphocytes at the same time The overexpression of these two factors is an important reason for many B lymphocyte related autoimmune diseases such as systemic lupus erythematosus It only took 23 days for taitasipu to be accepted by CDE from its listing application on November 13 to be included in the priority review Recombinant human nuranglin (rhNRG-1, neucardin ®) is a first-in-class genetic engineering new drug for the treatment of mild and moderate chronic heart failure The listing application was included in the priority review about one month after it was undertaken by CED on February 1, 2019 However, it was not approved by the National Bureau due to the lack of existing research data on February 12, 2020 A clinical study with cardiac function as the main efficacy index needs to be carried out, and pharmaceutical and pharmacotoxicological data need to be supplemented to support conditional approval for listing Table 3 new biological products and biological similar drugs included in the priority review in 2019 Six applications for the listing of bio similar drugs have been included in the priority review Among them, the market competition of adamumab bio similar drugs will be intensified There are three applicants: in addition to Haizheng pharmaceutical which has been approved for listing, there are also Xinda bio and Fuhong Hanlin Rituximab and bevacizumab bio similar drugs of Xinda bio have also been included in the priority review Fuhong Hanlin is expected to win the first approved listing Trastuzumab is a biologically similar drug Guangdong dongyangguang, Sinopharm Ouyi, humanwell pharmaceutical, Novartis, Haizheng pharmaceutical and Cinda bio are the enterprises that have obtained the most priority review of listing applications in 2019, and most of the drugs are still under review Guangdong dongyangguang (statistics include Yichang dongyangguang), Shiyao Ouyi and humanwell pharmaceutical, in addition to innovative drugs, also have the layout of children's drugs and drugs in the United States that apply for domestic listing simultaneously and are urgently needed clinically, making them the most qualified for priority review under the national incentive policies, and new drugs and generic drugs will enter the harvest period Xinda bio's three applications for listing bio similar drugs have been given priority review, which will further consolidate its position as the first tier of bio similar drugs Table 4 enterprises with the largest number of priority reviews of unlisted drugs in China in 2019
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.