The ranks of B7-H3-targeting antibody-drug conjugates under development in China have seen their first dropout, although elsewhere there are two FGFR2b-directed ADCs with first-in-class potential on the horizon. Meanwhile, there have been other discontinuations of KRAS G12C inhibitors and anti-BCMA CAR-T cell therapies in the country, while new players have surfaced in the areas of mRNA cancer vaccines and amyloid-beta-targeting antibodies for Alzheimer’s disease.

The company remained tight-lipped on the biomarker driving high response rates for its CDK9 inhibitor SLS009 from a Phase II trial, as a Phase III interim analysis for its AML cancer vaccine galinpepimut-S draws near.

CDER missed six goal dates among its 2023 novel approvals, reflecting safety concerns as well as pandemic-related inspection delays; Duchenne muscular dystrophy accelerated approval disagreements caused the biologics center’s lone missed goal.

Plus deals involving Menarini/VenatoRx, Orion/Glykos, Roche/MOMA, Janssen/Elektrofi, Galapagos/BridGene along with 13 other transactions.