Wednesday, July 08, 2020
Turning Point Therapeutics, Inc., a precision oncology company developing next-generation therapies that target genetic drivers of cancer, and Zai Lab, an innovative commercial-stage biopharmaceutical company, today announced an exclusive license agreement for the development and commercialization of Turning Point’s lead drug candidate, repotrectinib, in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan.
Under the terms of the agreement, Zai Lab will obtain exclusive rights to develop and commercialize repotrectinib in Greater China and Turning Point Therapeutics will receive a $25 million upfront payment, with potential to receive up to an additional $151 million in development, regulatory and sales-based milestone payments. Turning Point will also be eligible to receive mid-to-high teen royalties based on annual net sales of repotrectinib in Greater China.
“With more than 700,000 newly diagnosed lung cancer patients every year in Greater China, and the development and commercialization capabilities Zai Lab have shown over time in the region, we view Zai Lab as the ideal partner to help expand the potential reach of repotrectinib,” said Athena Countouriotis, M.D., President and Chief Executive Officer of Turning Point Therapeutics. “Our collaboration with Zai Lab is a strategic step to potentially accelerate the development of repotrectinib in Greater China.”
Zai Lab anticipates opening additional sites for the TRIDENT-1 Phase 2 registrational clinical study of repotrectinib. The ongoing study is currently active in 11 countries globally and enrolling patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and NTRK-positive solid tumors.
“We are very pleased to enter into this agreement with Turning Point Therapeutics. Repotrectinib is highly synergistic with Zai’s existing pipeline and further strengthens our disease area strongholds across most common tumor types in China, particularly in lung cancer. We are looking forward to bringing this potential best-in-class agent in the front-line setting and for patients previously treated with an approved tyrosine kinase inhibitor (TKI) where there are no approved targeted therapies,” said Samantha Du, Ph.D., Founder, Chairwoman and Chief Executive Officer of Zai Lab.
“In China, there is only one approved targeted therapy for patients with advanced ROS1-positive lung cancer and despite its efficacy, most patients eventually acquire resistance,” said Dr. Lu Shun, Director of Chinese Lung Cancer Association. “The unmet need in the ROS1-positive lung cancer patient population is significant. The preliminary clinical activity and safety data generated to date for repotrectinib represent a promising clinical profile. If approved, repotrectinib has the potential to be the standard of care for ROS1-positive patients with advanced non-small cell lung cancer in China.”
