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Blueprint Medicines, Zai Lab Ink $615M Licensing Agreement for EGFR Inhibitors

NEW YORK – Blueprint Medicines and Zai Lab on Tuesday entered into a collaboration and license agreement to develop and commercialize BLU-945 and BLU-701 in EGFR-mutated non-small cell lung cancer in greater China.

Zai Lab will pay Blueprint $25 million upfront, and Blueprint will be eligible for an additional $590 million in potential development, regulatory, and sales-based milestone payments. Zai Lab will also pay tiered royalties ranging from the low-teens to mid-teens on annual net sales of BLU-945 and BLU-701 in greater China, which includes mainland China, Hong Kong, Macau, and Taiwan.

BLU-945 and BLU-701 were developed to address resistance mechanisms in EGFR-driven NSCLC. Both drugs have shown activity against activating EGFR mutations and resistance mutations, including T790M and C797S. BLU-945 is being studied in the Phase I/II SYMPHONY trial involving patients with previously treated EGFR-driven NSCLC.

BLU-701 is still in preclinical studies, but Blueprint has filed an investigational new drug application with the US Food and Drug Administration and expects to begin a Phase I/II trial in EGFR-positive NSCLC next quarter.

"With more than 800,000 newly diagnosed lung cancer patients annually, one of the highest EGFR mutation rates in the world, and with no available therapies to address on-target resistance to early-generation EGFR therapies, we believe we have a tremendous opportunity to improve patient care in China," Zai Lab CEO Samantha Du said in a statement.