BioNTech Cancer Drug Licensed From MediLink Faces FDA Delay (1)

The Food and Drug Administration delayed a breast- and lung-cancer trial of an experimental treatment that BioNTech SE licensed from Chinese biotech MediLink Therapeutics Ltd., citing safety concerns.

MediLink stopped enrolling US patients in the study, which had aimed to recruit 80 volunteers to test a new antibody-drug conjugate, a type of medicine designed to deliver targeted therapy to a tumor, BioNTech said Monday. Run in China and the US, the study had been scheduled to deliver results at the end of this year, according to a US government registry of clinical trials.

The FDA told MediLink that it ...