China Hits Over 5,000 Clinical Trial Registrations in 2025 for First Time

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In 2025, China’s pharmaceutical innovation reached a historic milestone, with over 5,000 clinical trial registrations for the first time in a single year. Specifically, 5,215 clinical trials were registered on the country’s Drug Clinical Trial Registration and Information Disclosure Platform, marking a 6.4% increase from the previous year and doubling the number from 2020, according to a recent report from the country’s drug evaluation authority.

Of these, 72%, or 2,171 trials, were for first-in-class innovative drugs. Nearly 38% of these were dedicated to cancer treatments. First-in-class innovative drugs are globally groundbreaking pharmaceuticals that introduce new active substances and have not been previously approved either domestically or internationally. They can include chemical drugs, biological products, or traditional medicines, each characterized by unique active structures and confirmed pharmacological effects.

The report highlights that nearly 43% of the trials for these innovative drugs were Phase I studies, involving novel targets for therapy and cutting-edge drug development techniques such as cell and gene therapies. This substantial volume of early-stage trials underscores China’s growing ability to develop original pharmaceuticals. In fact, the number of Phase I clinical trials conducted domestically surpassed that of the United States last year, placing China at the top globally.

Additionally, almost 14% of the latest clinical trial registrations involved multi-regional studies, spanning over 70 countries and regions. The United States hosted the highest number of international trial sites, representing more than 22%. Japan, Germany, Spain, and Italy followed as the next leading locations.

The timeline from approval to the first patient enrollment continues to improve, with the average duration decreasing by four months from the previous year. Moreover, about 74% of trials obtained written informed consent from participants within six months of approval, up from 66% in 2024.