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  • Zynyz receives orphan drug designation in Korea
  • by Eo, Yun-Ho | translator Alice Kang | Sep 5, 2025 06:20am
The immuno-oncology drug will be introduced to Korea by Handok
First FDA-approved treatment option for anal cancer
Demonstrated improved survival in the POD1UM-303 study
The immuno-oncology drug Zynyz that Handok has decided to market in Korea has been designated as an orphan drug in Korea.

The Ministry of Food and Drug Safety (MFDS) recently announced the designation through a public notice. Specifically, the drug is indicated for ¡ãMerkel cell carcinoma and ¡ã squamous cell carcinoma of the anal canal (SCAC). Among these, the Merkel cell carcinoma indication had already been granted orphan drug status earlier in June.

Zynyz (retifanlimab), which was developed by the US company Incyte, was also designated in July as a subject for the ¡°Global Innovative Products on Fast Track (GIFT)¡± program.

Since receiving approval from the U.S. FDA in May, the PD-1 inhibitor Zynyz has been
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