Mirati Therapeutics & Zai Lab Enter Development & Commercialization Collaboration

Mirati Therapeutics, Inc. and Zai Lab Limited recently announced the companies have entered into a collaboration and license agreement for adagrasib, a small-molecule KRASG12C inhibitor, in Greater China (mainland China, Hong Kong, Macau, and Taiwan).

“We believe Zai Lab is an ideal partner to enable us to expand and accelerate Mirati’s global adagrasib development,” said Charles M. Baum, MD, PhD, President and Chief Executive Officer, Mirati Therapeutics, Inc. “Zai Lab has an established record of rapid and high quality development and commercialization of innovative oncology product candidates in China. Their capabilities position Mirati to further develop adagrasib for patients with cancer who harbor the KRASG12C mutation around the world.”

“We are delighted to collaborate with Mirati to bring adagrasib to patients in need in Greater China as soon as possible,” said Samantha Du, PhD, Founder, Chairperson, and Chief Executive Officer of Zai Lab. “Lung cancer is the most common cancer in China, and we aim to make adagrasib an important product in our growing lung cancer franchise. We are also excited about the potential of adagrasib to treat colorectal, pancreatic and other cancers characterized by KRASG12C mutations.”

Under the terms of the agreement, Zai Lab obtains the right to research, develop, manufacture, and exclusively commercialize adagrasib in Greater China. Zai Lab will support accelerated enrollment in key global, registration-enabling clinical trials of adagrasib in patients with cancer who have a KRASG12C mutation.

Mirati has an option to co-commercialize in Greater China and retains full and exclusive rights to adagrasib in all countries outside of Greater China. Mirati will receive a $65 million upfront payment, with the potential to receive up to an additional $273 million in development, regulatory, and sales-based milestone payments. Mirati is also eligible to receive high-teen- to low-twenties-percent tiered royalties based on annual net sales of adagrasib in Greater China.

Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C mutated cancers, which regenerates every 24-48 hours. Studies of adagrasib have shown that the drug has a long half-life and extensive tissue distribution and is well tolerated. Adagrasib has shown single-agent responses in non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer, and other solid tumors with KRASG12C mutations. Adagrasib is also being evaluated in several clinical trials in combination with other anticancer therapies with strong scientific rationale in patients with advanced solid tumors. Registration-enabling studies are ongoing in NSCLC and colorectal cancer. For more information, visit Mirati.com/science.

KRASG12C is the most common KRAS mutation in non-small cell lung cancer (NSCLC). The mutation is a biomarker of poor prognosis in Chinese patients with NSCLC. Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases. According to the World Health Organization, the incidence of lung cancer in China in 2020 was 815,563 cases, with 714,699 deaths.

Colorectal cancer (CRC) is the second most commonly diagnosed cancer type in China. According to the World Health Organization, the incidence of colorectal cancer in China in 2020 was 550,628 cases, with 283,751 deaths.

Mirati Therapeutics Inc. is a clinical-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer. For more information, visit Mirati.com.

Zai Lab is an innovative commercial-stage biopharmaceutical company focused on bringing transformative medicines for cancer and infectious and autoimmune diseases to patients in China and around the world. We aim to address significant unmet medical needs in large, fast-growing segments of the pharmaceutical market. Our experienced team has secured partnerships with leading global biopharmaceutical companies to generate a broad pipeline of potentially innovative, marketed products and product candidates. We have also built an in-house team with strong drug discovery and translational research capabilities and are establishing a pipeline of proprietary drug candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to positively impact human health worldwide. For more information, visit www.zailaboratory.com.