Chinese Journal of Dermatology ›› 2021, Vol. 54 ›› Issue (11): 1001-1004.doi: 10.35541/cjd.20210600

• Survey Report • Previous Articles     Next Articles

Analysis of clinical trials of dermatological drugs in China, 2020

Zhu Beibei1, Li Jing1, Huang Huiyao2, Li Ning2, Liu Lijun3, Zhang Lihua4, Huan Jing1, Ni Qi1, Hou Wei1, Liu Yi1, Yang Xueyuan1   

  1. 1Department of Clinical Trial Institution, Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China; 2Department of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China; 3Department of Clinical Trials Center, National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin 300020, China; 4National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China
  • Received:2021-08-18 Revised:2021-09-18 Online:2021-11-15 Published:2021-11-01
  • Contact: Yang Xueyuan; Liu Yi E-mail:yangxueyuan@medmail.com.cn; liuyi@ pumcderm.cams.cn
  • Supported by:
    Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences（2020-I2M-2-007）

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Abstract: 【Abstract】 Objective To deliver understanding of the latest research progress on clinical trials and approval of dermatological drugs in China in 2020. Methods A registration and information disclosure platform for drug clinical studies and a query system for domestic and imported drugs in the National Medical Products Administration of China were searched for registered clinical trials and approved dermatological drugs, respectively. The number and stages of clinical trials, indications and classification of involved products, and listed dermatological drugs in 2020 were summarized and depicted. Results There were 157 dermatological drug trials registered in China in 2020, accounting for 6.16% of all the 2 548 clinical drug trials, including 127 （80.9%） initiated by Chinese pharmaceutical enterprises and 25 （15.9%） international multicenter trials. Among the 127 drug trials initiated by Chinese pharmaceutical enterprises, bioequivalence trials were mostly common, accounting for 55.9% （71/127）. Compared with global pharmaceutical enterprises, domestic pharmaceutical companies initiated significantly decreased proportions of international multicenter trials （1.9% ［3/157］ vs. 14.0% ［22/157］, P < 0.001）, but significantly increased proportions of phaseⅠclinical trials and bioequivalence trials （24.4% ［31/127］ vs. 10.0% ［3/30］, 55.9% ［71/127］ vs. 0, respectively, both P < 0.001）. Totally, 90 kinds of dermatological drug were involved in all the trials, psoriasis, atopic dermatitis and melanoma were the most common indications, and innovative drugs accounted for 53.3% （48/90）; the proportion of innovative drugs was significantly lower in domestic pharmaceutical companies than in global pharmaceutical companies（43.2% ［32/74］ vs. 16/16, P < 0.001）. In addition, 28 dermatological drugs developed by 22 pharmaceutical companies were approved in China in 2020, of which 21 drugs were developed by domestic pharmaceutical companies. Conclusion Clinical drug trials carried out by domestic pharmaceutical companies mostly focus on generic drugs, and it is still necessary for domestic pharmaceutical companies to further improve the innovation ability.

Key words: Clinical trial, Skin diseases, Pharmaceutical preparations, China, Therapeutic equivalency