Policy & Regulation
Deciphera Pharmaceuticals, Zai Lab Ink Exclusive License Agreement for Ripretinib in Greater China
13 June 2019 - - US-based biopharmaceutical company Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH) and China and US-based innovative biopharmaceutical company Zai Lab Ltd. (NASDAQ: ZLAB) have inked an exclusive license agreement to advance the development and commercialisation of ripretinib in Greater China (mainland China, Hong Kong, Macau and Taiwan), the company said.
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 USD 20m and will be eligible to receive up to USD 185m 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 commercialisation 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.
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.
It was specifically designed to improve the treatment of GIST patients by inhibiting a broad spectrum of mutations in KIT and PDGFRα.
Ripretinib is a KIT and PDGFRα inhibitor that blocks initiating and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, involved in GIST as well as the primary D816V exon 17 mutation involved in SM.
Ripretinib also inhibits primary PDGFRα mutations in exons 12, 14 and 18, including the exon 18 D842V mutation, involved in a subset of GIST.
Deciphera Pharmaceuticals (NASDAQ: DCPH) is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies.
Its small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers.
The company uses its understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a "switched off" or inactivated conformation.
These investigational therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages.
We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their responses to treatment.
Zai Lab (NASDAQ: ZLAB) is a China and US-based innovative commercial stage biopharmaceutical company focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world.
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