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ZIIHERA BeOne Medicines AUS Pty Ltd
Product name
ZIIHERA
Sponsor
Accepted date
Apr-2026
Active ingredients
zanidatamab
Summary of proposed indication
ZIIHERA (zanidatamab) is proposed as a treatment for adults with HER2-positive biliary tract cancer (cancers that form in the bile ducts or the gallbladder) that has already been treated, cannot be removed with surgery, and has spread nearby or to other parts of the body.
Application type
A (new medicine)
Publication date
Apr-2026
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration.