The company announced a series B-2 financing of $158m that it plans to use for pivotal Phase II development of TORL-1-23, which it called a first-in-class agent.

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.

After a US FDA site inspection raised questions about the contract manufacturer of the potential first-in-class Claudin 18.2 inhibitor that could not be answered by the original January PDUFA date, Astellas will need to refile the application, but has not committed to when that might be.

Astellas has received a US CRL for it's potential first-in-class drug zolbetuximab, after questions over a manufacturing line came up after an FDA site inspection and could not be answered by the original 12 January PDUFA date. The Japanese firm will refile the application after resolving the issues, but the likely revised timeline is not yet clear.