(Yicai) June 23 -- China’s new drug research and development has achieved a historic milestone, as the number of annual clinical trial registrations exceeded the 5,000 mark for the first time last year.

A total of 5,215 clinical trials were registered on China’s Drug Clinical Trial Registration and Information Disclosure Platform in 2025, up 6.4 percent from the year before and doubling from 2020, according to a report released by the Center for Drug Evaluation under the National Medical Products Administration yesterday.

Seventy-two percent or 2,171 of the clinical trial registrations last year were for Class 1 innovative drugs, nearly 38 percent of which were anti-tumor treatments, the report showed.

Class 1 innovative drugs are first-in-class global innovative pharmaceuticals, according to the NMPA. They can be chemical drugs, biological products, or traditional Chinese medicines with novel active substance structures and definite pharmacological effects, featuring independent clinical value and never approved for marketing either domestically or overseas.

The report also showed that almost 43 percent of the 2,171 tests for Class 1 innovative drugs were Phase I trials last year. They cover novel therapeutic targets and innovative drug development modalities, including cell therapy and gene therapy, said Li Ning, chief physician at the clinical trial center of the National Cancer Center of China.

The high volume of Phase 1 clinical trials reflects China’s capacity for original pharmaceutical innovation, Li noted, adding that the number of Phase I clinical trials in China surpassed that in the United States last year to rank first globally.

Nearly 14 percent of last year’s new clinical trial registrations were for multi-regional tests, covering sites across more than 70 countries and regions, according to the report. The US hosted the largest number of overseas trial sites, accounting for more than 22 percent of the total. Japan, Germany, Spain, and Italy rank second to fifth.

The average time gap between a company obtaining clinical trial approval and the enrollment of its first subject was shortened by four months in 2025 from the year before, the report also showed. Around 74 percent of all projects secured written informed consent from their first enrolled subjects within six months of receiving approval last year, up from 66 percent in 2024.

Editors: Tang Shihua, Futura Costaglione