Deciphera Pharmaceuticals and Zai Lab Limited Announce Exclusive License Agreement

Deciphera Pharmaceuticals, Inc. and Zai Lab Ltd. recently 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.

“We believe Zai Lab is the ideal partner for the development and potential commercialization of ripretinib in Greater China,” said Steve Hoerter, President and Chief Executive Officer of Deciphera. “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 Lab to potentially offer patients in Greater China what we believe is a much needed therapeutic option for the treatment of GIST.”

“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,” said Dr. Samantha Du, Chairman and Chief Executive Officer of Zai Lab. “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.”

“Each year in China, approximately 30,000 patients are newly diagnosed with GIST, and an estimated 100,000 GIST patients are currently under treatment,” said Dr. Lin Shen, Head of the Chinese Society of Clinical Oncology GIST Expert Committee and Vice President of Clinical Oncology at Beijing Cancer Hospital. “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. 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 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. Our 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. We use our deep 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 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. Zai Lab’s experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates targeting the fast-growing segments of China’s pharmaceutical market and addressing unmet medical needs. Zai Lab’s vision is to become a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing its partners’ and its own products in order to impact human health worldwide.

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