Breakthrough Therapy Designations in China and the United States

Since 2020, the Chinese NMPA received nearly twice as many breakthrough therapy designation (BTD) applications for drugs as the FDA, but granted a lower percentage than the US regulator. Most BTDs in China were for domestically developed drugs, and oncology led BTD approvals in both countries. As use of the BTD pathway continues, both countries should create clear, rigorous evaluation criteria to ensure the pathway prioritizes truly promising new therapies.