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  • GIST drug Qinlock receives orphan drug designation in KOR
  • by Eo, Yun-Ho | translator Alice Kang | Aug 6, 2025 06:09am
Selected as MFDS's GIFT candidate in July... Approved in the US in 2020
Demonstrated efficacy through the INVICTUS study, including improvement in PFS
The GIST treatment Qinlock has been designated as an orphan drug in Korea.

The Ministry of Food and Drug Safety announced the news through a public notice on the 4th. Ono Pharmaceutical's gastrointestinal stromal tumor (GIST) treatment Qinlock (ripreitinib) had previously been designated as a Global Innovative Products on Fast Track (GIFT) drug last month.

Qinlock is used to treat patients with advanced GIST who have a history of treatment with three or more kinase inhibitors, including Gleevec (imatinib).

Qinlock has also been designated as an orphan drug by the US FDA and the European EMA. It was selected for Fast Track review and received the Breakthrough Therapy Designation (BTD) from the FDA and receive
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