Qinlock approved in Taiwan for treatment of GIST

Shanghai, China headquartered Zai Lab (Nasdaq: ZLAB) has announced that the Taiwan Food and Drug Administration has approved its New Drug Application (NDA) for Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. Qinlock targets the broad spectrum of KIT and PDGFRα mutations known to drive GIST.

Zai Lab and its partner Deciphera (Nasdaq: DCPH) are also exploring the use of Qinlock to treat patients with second-line GIST. Deciphera has completed target enrollment in the Phase III INTRIGUE study of Qinlock in patients with second-line GIST, with top-line results anticipated in the fourth quarter of 2021.

Zai Lab has an exclusive license agreement with Deciphera for the development and commercialization of ripretinib in Greater China (mainland China, Hong Kong, Macau and Taiwan) for which it paid $20 billion upfront along with a commitment to pay up to $185 million in potential development and commercial milestones, plus royalties on sales to Deciphera.