The first HER2 bispecific antibody drug Ziihera has received an orphan drug designation in Korea.

The Ministry of Food and Drug Safety (MFDS) recently announced so through the first orphan drug designation in the new year.

Its specific indication is for the treatment of adult patients with previously treated unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer.

Ziihera (zanidatamab), a bispecific antibody that targets the HER2 gene, received accelerated approval from the U.S. FDA in November last year after demonstrating efficacy in patients with biliary tract cancer.

This is the first time that a bispecific antibody targeti