Deciphera Pharmaceuticals, a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, and Zai Lab Ltd, a China and U.S.-based innovative biopharmaceutical company has announced an exclusive license agreement to advance the development and commercialization of ripretinib in Greater China (mainland China, Hong Kong, Macau and Taiwan).

Discovered and developed by Deciphera, ripretinib is an investigational, oral, kinase switch control inhibitor in clinical development for the treatment of GIST and other solid tumors driven by KIT or PDGFRα.

Under the terms of the agreement, Deciphera will receive an upfront cash payment of $20 million and will be eligible to receive up to $185 million in potential development and commercial milestone payments. In addition, Zai Lab would pay Deciphera royalties from low to high teens on annual net sales of ripretinib in Greater China. Zai Lab receives exclusive regional development and commercialization rights for ripretinib in Greater China. 

Zai Lab plans to leverage its regulatory and clinical expertise to lead development of ripretinib in this territory. Deciphera intends to expand the ongoing global Phase 3 INTRIGUE study, comparing ripretinib to sunitinib in second-line GIST patients, and is currently assessing the addition of clinical trial sites in China.

Steve Hoerter, President and Chief Executive Officer of Deciphera said, “We believe Zai Lab is the ideal partner for the development and potential commercialization of ripretinib in Greater China. Zai Lab’s strong track record of rapidly progressing the development of innovative product candidates will be a major asset in accelerating the development of ripretinib in this area of the world. We are excited to be working with Zai Labto potentially offer patients in Greater China what we believe is a much needed therapeutic option for the treatment of GIST.”

Dr. Samantha Du, Chairman and Chief Executive Officer of Zai Lab said, “We are very pleased to enter into this exclusive agreement for ripretinib and look forward to partnering with Deciphera to potentially bring ripretinib to GIST patients in Greater China. Based on encouraging clinical data reported to-date, we believe ripretinib, if approved, could alter the treatment landscape for GIST patients. Ripretinib has strong clinical and commercial synergies with our existing pipeline of late stage gastrointestinal cancer programs. We are committed to working with Deciphera to expand the global effort to bring this important potential therapy to patients.”

Dr. Lin Shen, Head of the Chinese Society of Clinical Oncology GIST Expert Committee and Vice President of Clinical Oncology at Beijing Cancer Hospital said, “Each year in China, approximately 30,000 patients are newly diagnosed with GIST, and an estimated 100,000 GIST patients are currently under treatment. There are significant unmet medical needs in GIST treatment especially for refractory patients after imatinib therapy. Based on preliminary data, I believe that ripretinib has a promising efficacy and safety profile that, if approved, could make it a good potential option for GIST patients.”

Ripretinib is an investigational KIT and PDGFRα kinase switch control inhibitor in clinical development for the treatment of KIT and/or PDGFRα-driven cancers, including GIST, systemic mastocytosis, or SM, and other cancers.

Ripretinib was specifically designed to improve the treatment of GIST patients by inhibiting a broad spectrum of mutations in KIT and PDGFRα.