The Ministery of Food and Drug Safety said on the 19th it approved the rare bile duct cancer treatment "Zheheraju 300 mg (zanidatamab)."
Zheheraju is an anticancer drug developed by U.S.-based Jazz Pharmaceuticals and was approved by the U.S. Food and Drug Administration (FDA) in Nov. 2024 as a treatment for HER2-positive bile duct cancer. The domestic approval covers adult patients with unresectable or locally advanced or metastatic HER2-positive bile duct cancer who have previously received at least one line of systemic therapy.
This drug is a bispecific antibody targeting patients with HER2 protein overexpression (IHC 3+), binding to two different HER2 epitopes (ECD2, ECD4) to inhibit signal transduction and block tumor cell proliferation. It is the first domestic approval for this indication.
Bile duct cancer is often detected at an advanced stage at diagnosis and has limited treatment options, and this approval is meaningful in that it adds a new treatment option.
The Ministery of Food and Drug Safety designated the product as No. 40 under the "Global Innovative product Fast Track (GIFT)" support system and applied priority review. This shortened the approval period and moved up the timeline for its introduction in Korea.
The Ministery of Food and Drug Safety said it plans to continue related support to ensure the swift supply of treatments for rare and intractable diseases.