Abstract
OBJECTIVES: To describe and compare the research and development (R&D) pipeline of cancer new drugs and newly approved drugs in China and the USA in 2020, thus to provide decision-making evidence for related stakeholders. METHODS: Clinical trials and tested cancer new drugs information in China and the USA were respectively acquired from Information Disclosure Platform for Drug Clinical Studies and Trialtrove database. Drug approval was tracked from the official release. Subgroup comparison in terms of initiated trials and drugs were conducted between the two countries. RESULTS: In 2020, 577 trials on 335 cancer new drugs were registered in China, accounting for 22.6% of all clinical drug trials, while in the USA, 916 trials on 678 cancer new drug trials were captured, accounting for 19.9% of the total. Relatively, a lower proportion of earlier phase (76.9% vs 87.4%), global (17.7% vs 39.0%), and top 20 pharmaceutics contribution (15.8% vs 43.2%) were found for cancer drug trials initiated in China. The fight against solid tumor took top billing in both countries, and the different distribution of cancer indications associated with cancer spectrum was also observed. Compared with the USA, more targeted agents (87.5% vs 77.0%, P < 0.001) and less immune agents (30.7% vs 41.6%, P < 0.001) were tested in China. In addition, 16 and 18 anticancer new drugs were approved in China and the USA, with 6 (37.5%) and 17 (94.4%) drugs being firstly approved worldwide, respectively. Among them, 32 drugs were granted by at least one expedited program, and 31 drugs were approved based on evidence from surrogate endpoints. A total of 17 cancer types were covered, and only one drug was targeted on digestive cancers, including gastric, liver, and esophageal cancers. CONCLUSIONS: R&D of anticancer new drugs is substantial, and great progress has been made in both China and the USA in 2020. The difference and gap between China and the USA highlight that more efforts should be paid to anticancer drug R&D on innovative agents and cancers unique to Chinese populations, as well as to facilitate global synchronous R&D in China.