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QED Therapeutics, Helsinn Group Ink $2B Agreement to Codevelop Infigratinib in Oncology

NEW YORK – QED Therapeutics and Helsinn Group entered into a $2 billion licensing agreement on Wednesday to codevelop and commercialize QED's FGFR1-3 inhibitor, infigratinib, in oncology in the US.

Under the terms of the deal, QED, a subsidiary of BridgeBio, will be eligible to receive up to $2 billion in upfront, regulatory, milestone, and royalty payments related to infigratinib. If the drug achieves US regulatory approval, QED and Helsinn will co-commercialize it in oncology indications in the US and will evenly split profits and losses.

Helsinn, headquartered in Switzerland, will also have exclusive rights to develop infigratinib in all other indications except skeletal dysplasias outside the US, excluding China, Hong Kong, and Macau. In these latter markets, BridgeBio partnered with Shanghai-based LianBio last year to develop and commercialize the drug.

BridgeBio and Helsinn have already begun a joint clinical investigation of the drug in first-line bile duct cancer and adjuvant urothelial cancer. They also plan to investigate infigratinib as a treatment for other FGFR-driven cancers.

"We are privileged to partner with Helsinn as we strive to unlock the full potential of infigratinib for patients with FGFR-driven cancers," BridgeBio CEO Neil Kumar said in a statement. "Helsinn has an impressive track record of advancing and commercializing oncology therapies around the globe. Our hope is that partnering with Helsinn will significantly strengthen our anticipated upcoming launch of infigratinib and our ongoing research into infigratinib's potential across other cancer indications."

QED submitted a new drug application for infigratinib to treat FGFR-altered bile duct cancer with the US Food and Drug Administration last year and received priority review status. The company is also studying infigratinib in a Phase III study involving urothelial cancer patients with a targetable FGFR3 alteration and a Phase II trial involving patients with solid tumors driven by FGFR1-3 gene fusions or translocations and other FGFR alterations.