US FDA approves the PD-1 inhibitor 20 months after user fee goal, resolving one of the last applications delayed by China’s extended pandemic travel restrictions.

The success of Enhertu led Daiichi Sankyo to raise its annual forecast for the fiscal year ending 31 March, while Eisai is readying for Leqembi’s steady US growth. Meanwhile, Astellas, Chugai and Shionogi balanced growth for some products with declines for others.

CDER holds steady with a median time to approval of 11 months, while CBER posts 10.5 month median review time for its largest novel approvals class.

Companies from China single-handedly sponsored a total of eight Phase III clinical studies that included US sites in 2023 compared to six in 2022 - but the figure was still below the record of 11 in 2021.