Clinical trials for drugs in China have increased dramatically over the last 5-7 years. In September, China’s Center for Drug Evaluation (CDE) within the NMPA issued the – Annual Report on Progress of Clinical Trials for New Drug Registration in China (2022). This report, which utilizes data from the Drug Clinical Trials Registration and Information Publicity Platform, examines data in China for new clinical trials. Some of the findings in this report are outlined below.
In 2022, there were 2,410 new clinical trials, a slight increase over 2021. About 89% of these clinical trials were sponsored by domestic Chinese companies with the rest having foreign sponsors – which was less than foreign sponsors had previously initiated in prior years. About 50% of new drug clinical trials were for chemical drugs, and 43% for biologics. Cancer drug clinical trials comprised more than 38% of the total. With respect to the type of clinical trial, Phase 1 trials accounted for approximately 44%, Phase 2 trials almost 20%, and Phase 3 trials exceeded 20%. While there has been an increase in trials for rare diseases, the number of pediatric trials has remained low at less than 10%. Over the last few years, with increased R&D and new drug discoveries in China, the number of clinical trials for brand-new drugs has increased significantly.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.hankunlaw.com/en/portal/article/index/cid/8/id/13674.html