目的 探讨中国特应性皮炎治疗药物注册临床试验研究现状及发展趋势，为申办方、研究人员和监管部门提供参考。方法 登陆药物临床试验登记与信息平台（http://www.chinadrugtrials.org.cn/index.html） ，以“特应性皮炎”为关键词，检索自平台上线以来（2012年11月）至2025年12月31日登记的特应性皮炎治疗药物临床试验信息，统计注册时间、药物名称、剂型、药物分类、适应证、试验分期、研究进度、设计类型、组长单位、申办方等。基于国家药品监督管理局药品审评中心（https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c）公示信息检索药品注册分类。登陆新药情报（https://synapse.zhihuiya.com/）数据库、摩熵医药（https://data.pharnexcloud.com/1/table/44）数据库，结合申请人信息及申请人官方网站公示药品研发相关信息，检索药物作用机制。采用Microsoft Office Excel软件汇总录入，进行数据整理。结果 共检索到特应性皮炎治疗药物注册临床试验388项，其中1类新药临床试验191项（49.2%）。试验分期方面，I期临床试验85项（21.9%）、I/Ⅱ期临床试验15项（3.9%）、Ⅱ期临床试验67项（17.3%）、Ⅱ/Ⅲ期临床试验3项（0.8%）、Ⅲ期临床试验62项（16.0%）、Ⅲ/IV期临床试验1项（0.2%）、IV期临床试验4项（1.1%）、生物等效性（BE）试验151项（38.9%）。涉及药物共113个，化学药物71个、生物制品41个、中药/天然药物1个。试验药物涉及多种不同作用机制，其中抗体类药物38个（33.6%）、Janus激酶（JAK）抑制剂34个（30.1%）、磷酸二酯酶4（PDE4）抑制剂12个（10.6%）。所有药物中1类创新药共81个。牵头单位统计结果显示，排名前3的为北京市86项（22.1%）、上海市45项（11.5%）、湖南省45项（11.5%）。结论 特应性皮炎治疗新药临床试验基本处于早期阶段，距离获批上市尚需时日。试验预期纳入受试对象多为成年人，儿童用药研发不足。新靶点药物开发是特应性皮炎研究热门方向，但需警惕失败风险。从1类新药临床试验申请人分析，国内企业占比较大，展示了中国企业在特应性皮炎药物研发方向的发展实力。从牵头单位地域分布来看，呈现全国分布不均衡情况。

Objective To explore the current status and development trends of registered clinical trials for atopic dermatitis (AD) treatment drugs in China, and to provide a reference for sponsors, researchers and regulatory authorities. Methods Log in to the Drug Clinical Trial Registration and Information Disclosure Platform (http://www.chinadrugtrials.org.cn/index.html), search for clinical trial information of drugs for AD registered from the platform’s launch date (November 2012) to December 31, 2025, using “atopic dermatitis” as the keyword. Collect data including registration time, drug name, dosage form, drug classification, indication, trial phase, study progress, study design type, leading institution, and sponsor. Retrieve the drug registration classification based on the public information from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c). The mechanism of drug action was obtained by searching the New Drug Intelligence Database (https://synapse.zhihuiya.com/) and Pharnexcloud Pharmaceutical Database (https://data.pharnexcloud.com/1/table/44), combined with the drug research and development information published on the official websites of the applicants. Relevant information is summarized and entered using Microsoft Office Excel for data sorting and organization. Results A total of 388 registered clinical trials for AD treatment drugs were retrieved, including 191 clinical trials of Class 1 new drugs (49.2%). In terms of trial phases: 85 were Phase I trials (21.9%), 15 were Phase I/II trials (3.9%), 67 were Phase II trials (17.3%), 3 were Phase II/III trials (0.8%), 62 were Phase III trials (16.0%), one was Phase III/IV trial (0.2%), 4 were Phase IV trials (1.1%), and 151 were bioequivalence trials (38.9%). A total of 113 drugs were involved, including 71 chemical drugs, 41 biological products, and 1 traditional Chinese medicine/natural medicine. The trial drugs covered multiple mechanisms of action, among which 38 were antibody drugs (33.6%), 34 were Janus kinase (JAK) inhibitors (30.1%), and 12 were PDE4(phosphodiesterase-4) inhibitors (10.6%). Among all drugs, 81 were Class 1 innovative drugs. Statistics on leading institutions showed that the top three regions were Beijing with 86 trials (22.1%), Shanghai with 45 trials (11.5), and Hunan Province with 45 trials (11.5%). Conclusions Most clinical trials of new drugs for AD are in the early stages, and there is still a considerable time before they obtain approval for marketing. The trial is expected to enroll predominantly adult subjects, reflecting a lack of adequate investment in pediatric drug development. The development of drugs targeting new molecular targets is a hot direction in AD research, but the risk of failure warrants attention. Analysis of the applicants for clinical trials of Class 1 new drugs shows that domestic enterprises account for a relatively large proportion, demonstrating the innovative strength of Chinese enterprises in the field of AD drug research and development. From the perspective of the geographical distribution of leading institutions, there is an imbalance across the country. In the future, we hope that the launch of more new therapeutic drugs for AD treatment will provide all AD patients with more effective, safe and personalized treatment regimens, ultimately achieving the leap from disease control to disease prevention, and even to disease cure.

R287.6

辽宁省教育厅青年项目（JYTQN2023153）；辽宁省博士科研启动基金（2025-BS-0678）