Abstract
OBJECTIVE: To deliver a comprehensive picture of the landscape and changing trend of trials and approvals on targeted anticancer drugs in China from 2012 to 2021. METHODS: Trials, investigated products, and listed drugs were acquired from national databases. The status quo, changing trend of absolute number, and proportion of targeted trials, products, and drugs, as well as the corresponding difference between domestic and foreign companies were analyzed. RESULTS: A total of 2,632 trials on 1,167 targeted antitumor drugs were identified, accounting for 81.5% of all registered trials. The number and proportion of trials on targeted drugs increased steadily, with an average growth rate of 36.0% and 6.2%, respectively. A similar growth trend was observed in the number (33.7%) and proportion (13.8%) of targeted drugs. Targeted drugs and trials owned by domestic companies accounted for a higher proportion than that by foreign companies (80.5% vs. 19.5%; 83.2% vs. 16.8%, respectively), and the growing trend for both targeted drugs (13.8% vs. 5.7%) and trials (13.8% vs. 33.7%) owned by domestic companies was faster. The proportion of targeted drug trials (80.5% vs. 85.6%) and multicenter trials (6.0% vs. 69.9%) initiated by domestic companies was lower than that by foreign companies, with the gap gradually narrowing. Among the identified 18 targets of the 126 immune drugs under development, only one globally new target was found. CONCLUSIONS: Research and development of targeted antitumor drugs in China are booming and advancing rapidly, and domestic enterprises have become the pillar. Encouraging genomics activities and establishing incentives and public-private collaboration frameworks are crucial for innovation-oriented drug development in China.