Marketing approval obtained in China for Meiyouheng (Becotatug Vedotin injection)

CAR-T Digest - August 2020

30 October 2025: Marketing approval obtained in China for Meiyouheng (Becotatug Vedotin injection)

The NMPA has granted marketing approval in China for Becotatug Vedotin injection, an innovative EGFR-targeted ADC developed for recurrent or metastatic nasopharyngeal cancer (R/M NPC)
Becotatug Vedotin is the first EGFR-targeted ADC approved in China, marking a significant milestone with first-in-class potential to improve treatment outcomes in R/M NPC
The ADC combines an EGFR-targeting monoclonal antibody with monomethyl auristatin E (MMAE) via a valine-citrulline linker, enabling selective tumor cell killing through internalization and controlled payload release
In pivotal trials, Becotatug Vedotin showed clinically meaningful efficacy and a manageable safety profile in patients who failed ≥2 prior systemic therapies including PD-L1 inhibitors, results were featured as a late-breaking abstract at ASCO 2025
The combination of Becotatug Vedotin and Puyouheng (Pucotenlimab injection) achieved a cORR of 73.3% and median PFS of 10.9 months in Phase 2 studies, as presented at ESMO 2025, suggesting a strong new treatment option for heavily pretreated R/M NPC patients