中华皮肤科杂志 ›› 2021, Vol. 54 ›› Issue (11): 1001-1004.doi: 10.35541/cjd.20210600

• 调查报告 • 上一篇    下一篇

2020年中国皮肤病药物临床试验分析

朱蓓蓓1    李婧1    黄慧瑶2    李宁2    刘利军3    张丽华4    宦静1    倪琪1    侯伟1    刘毅1    杨雪源1   

  1. 1中国医学科学院、北京协和医学院皮肤病医院机构办公室，南京  210042；2国家癌症中心  国家肿瘤临床医学研究中心  中国医学科学院、北京协和医学院肿瘤医院药物临床试验研究中心，北京  100021；3中国医学科学院、北京协和医学院血液病医院临床试验研究中心，天津  300020；4国家心血管病中心  国家心血管疾病临床医学研究中心  中国医学科学院、北京协和医学院阜外医院心血管疾病国家重点实验室，北京  100037
  • 收稿日期:2021-08-18 修回日期:2021-09-18 发布日期:2021-11-01
  • 通讯作者: 杨雪源；刘毅 E-mail:yangxueyuan@medmail.com.cn; liuyi@ pumcderm.cams.cn
  • 基金资助:
    中国医学科学院医学与健康科技创新工程临床试验能力提升（GCP）平台建设项目（2020-I2M-2-007）

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 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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摘要： 【摘要】 目的 了解2020年中国皮肤病药物临床试验开展及上市情况。方法 从中国国家药品监督管理局药物临床试验登记与信息公示平台登记数据库和国产及进口药品数据查询系统，收集2020年皮肤病药物注册临床试验信息，包括试验数量、分期和受试药物主要适应证、类型等信息以及上市皮肤病药物情况。结果 2020年共有157项皮肤病药物注册临床试验在中国药物临床试验登记与信息公示平台登记，占同期全部药物临床试验（2 548项）的6.16%。其中，中国制药企业发起127项（80.9%），国际多中心试验25项（15.9%）。生物等效性临床试验在国制药企业发起的临床试验中占比最高（55.9%，71/127）。国内制药企业发起的国际多中心临床试验占比低于国际制药企业［1.9%（3/157）比14.0%（22/157），P < 0.001］，Ⅰ期临床试验和生物等效性试验占比［24.4%（31/127）和55.9%（71/127）］高于国际制药企业［10.0%（3/30）和0，均P < 0.001］。共涉及90种试验药物，银屑病、特应性皮炎、皮肤黑素瘤是常见适应证，创新药占53.3%（48/90）；国内制药企业创新药比例低于国际制药企业［43.2%（32/74）比16/16，P < 0.001］。2020年，共有22家制药企业研发的28种皮肤病治疗药物在中国获准上市，其中21种来自国内制药企业。结论 国内制药企业开展的药物临床试验多集中于仿制药，需进一步提高创新能力。

关键词: 临床试验, 皮肤疾病, 药用制剂, 中国, 治疗等效

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