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Volume 13 Issue 6
Nov.  2022
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SUN Wenjuan, ZHANG Bo. Current Situation and Implications of Novel Antitumer Drugs in China[J]. Medical Journal of Peking Union Medical College Hospital, 2022, 13(6): 1036-1044. DOI: 10.12290/xhyxzz.2021-0521
Citation: SUN Wenjuan, ZHANG Bo. Current Situation and Implications of Novel Antitumer Drugs in China[J]. Medical Journal of Peking Union Medical College Hospital, 2022, 13(6): 1036-1044. DOI: 10.12290/xhyxzz.2021-0521
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Current Situation and Implications of Novel Antitumer Drugs in China

  • 1.

    Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

  • 2.

    State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China

Funds: 

National High Level Hospital Clinical Research Funding 2022-PUMCH-B-059

More Information
  • Corresponding author:

    ZHANG Bo, E-mail: zhangbopumchpumch@163.com

  • Received Date: July 08, 2021
  • Accepted Date: September 12, 2021
  • Issue Publish Date: November 29, 2022
    Graphical Abstract
    • Abstract
  •   Objective  To explore the trend of antitumor drugs by comparing and analyzing the novel antitumor drugs of China and US, in order to provide a basis for the selection of antitumor drugs.
      Methods  US Food and Drug Administration and China National Medical Products Administration databases were searched, and the drug name, marketing time, indication and other information were collected(as of April 30, 2021). The proportion of listed drugs in China were calculated.
      Results  As of April 30, 2021, there were 122 novel antitumor drugs marketed in the US, covering 14 disease types. Among them, 41.80% (51/122) were marketedin China. The proportion of monoclonal drugs was the highest(46.15%), followed by the small molecule targeted drugs (44.58%), and antibody-drug conjugate (15.38%). The number of novel antitumor drugs increased significantly(70.59%, 36/51) since 2015, and the proportion of listed drug in China from 2015 to 2021 was 50.70%(36/71), while that from 2010 to 2014 was only 19.35%(6/31). China has imported novel antitumor drugs covering 13 disease types. The average proportion of imported novel antitumor drugs for the top 5 tumors in China was 62.15%. A total of 14 novel antitumor drugs have been independently developed in China, including 7 monoclonal drugs and 7 small molecule targeted drugs, accounting for 21.54% (14/65) of the available novel antitumor drugs in China. Among them, 11 drugs (78.57%, 11/14) have been listed since 2015. The indications of novel antitumor drugs independently developed in China cover 8 disease types (57.14%, 8/14).
      Conclusions  There are still gaps between China and US in terms of novel antitumor drugs, but these drugs can basically meet the clinical needs in China. Since 2015, China has made progress in accelerating approval and independent innovation. We should consider the safety, effectiveness, economic and clinical necessity of the listed and unlisted drugs, so as to provide a basis for drug selection in the future.
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    • References (30)
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