Analysis of Clinical Trials of New Drugs for Liver Diseases in China

Abstract

Background

Liver diseases are a major public health concern worldwide, and the development of novel therapeutic drugs is an important research focus. But no overview has been conducted so far on the current research and development for liver-specific drugs in China, and the actual situation regarding the development and evaluation of new drugs in clinical trials.

Methods

The information of all clinical trials on liver diseases were obtained through the “Pharmaceutical Clinical Trial Registration and Information Disclosure Platform” before December 31, 2020.

Results

A total of 751 clinical trials on liver disease-related drugs were published on the above platform, including 574 chemical drugs, 128 biological products, and 49 traditional Chinese medicine (TCM)/natural drugs. The number of annual registrations has increased on an annual basis. The main indications for these clinical trials are viral hepatitis, liver malignancies, liver abscess, liver transplantation, congenital liver metabolic disease, and other hepatitis-related diseases. Hepatitis B, hepatitis C and liver cancer accounted for 72.4% of the total clinical trials, and the majority are related to generic drug research. There are 103 innovative drugs currently in clinical testing, mainly for hepatitis B, hepatitis C and hepatocellular carcinoma.

Conclusion

The stronger macro-control is required for the clinical trials conducted in China, and it is necessary to identify new therapeutic targets and develop novel drugs for the key liver diseases, as well as preventive hepatitis C vaccines, and targeted therapy, TCM/natural drugs and immunotherapy for liver cancer.

Keywords:

• clinical trials
• liver diseases
• hepatitis B
• hepatitis C
• liver cancer

Acknowledgment

Thanks are due to Yuling Liu for assistance with the data collation in the process of manuscript revision.

Abbreviations

CHC, chronic hepatitis C, CTLA-4, cytotoxic T lymphocyte antigen-4; DAAs, direct antiviral agents; DCV, daclatasvir; HBV, hepatitis B virus; HCC, hepatocellular carcinoma; HCV, hepatitis C virus; IFNα, interferon alpha; NTCP, sodium taurocholate cotransporting polypeptide; R&D, Research and Development; RBV, ribavirin; SFDA, State Food and Drug Administration; TCM, traditional Chinese Medicine; TLR-7, Toll-like receptor-7; TNFα, tumor necrosis factor; Tα1, thymosin-α1; WHO, World Health Organization.

Disclosure

The authors declare that they have no conflicts of interest in this work.

Additional information

Funding

This study was financially supported by the Fundamental Research Funds for the Central public welfare research institutes (ZZ13-YQ-059).