Review of the Chinese Landscape in Phase 1 Clinical Trials for Noncancer Innovative Drugs Over 2015 to 2020.

Abstract

In recent years, the research and development (R&D) of innovative drugs in China has been dramatically accelerated. And the early clinical study is crucial for drug R&D. However, little is known involving the change of phase I trials for noncancer drugs. We retrieved the data of phase I clinical trials for noncancer innovative drugs on the Registration and Information Disclosure Platform for Drug Clinical Studies on the Center for Drug Evaluation. The number of clinical trials proliferating in recent years and the average annual growth rates of chemical and biological drugs were 55.5% and 42.1%, respectively. Most trials were distributed in Beijing, Shanghai, and other developed coastal cities. Moreover, the clinical trials of innovative drugs in China were focused on the digestive and endocrine systems, whereas the pediatric and orphan drugs were scarce. Based on the data assessment, this work provided comprehensive analysis and suggestions about Chinese drug R&D. Significant advancement has been made in mainland China with the implementation of available policies and the emergence of advanced technologies. Though shortcomings, including uneven geographic distribution and lack of pediatric and orphan drugs, still exist, we believe progress will continue to be made in mainland China.